Department of Pharmaceutics Graduate Review Schedule March 18-20th 2008 Jeff ‘s Cell Phone # 352 219-6603

March 18th (Travel and check in the hotel)

Dr. Juliano will be driving up from Tampa and should be here about 5pm Dr. Khan is flying in on Delta Flight 4627 and should be here about 2pm Dr. Zimmerman is flying in on Delta Flight 4338 and should be here about 4:25pm

Jeff Hughes will transport Dr. Khan and Zimmerman from the Airport to the Hotel

Dinner 7 pm meet in the Hotel Lobby

March 19th

8:00 AM Jeff Hughes will transport review panel from hotel to the College of Pharmacy

8:30 Meet with Dr. Millard and Palmieri (Dean’s Conference Room)

9:45 Meeting with Graduate Faculty (p4-20)

11:00 Tour of Pharmaceutics Facilities

11:30 Tour of Pharmacy Practice Facilities

12-1:30 Lunch with Graduate Students and Post-Doctoral Fellows (p4-20)

1:30-2:00 Break

2:00-4:00 Graduate Student Presentations (p4-20)

4:00-5:00 Dr. Johnson and Dr. Derendorf (p3-04)

Transport to Hotel

7 pm Meet in hotel lobby for dinner

March 20th

8:30 Panel Report Preparation Time

10:00 Transport to UF (Jeff Hughes) Meet in Hotel Lobby

10:30 Dean Henry Frierson, Room 164 Graduate School 392-6622

11:30 Dean Millard and Dr. Palmieri (Dean’s Conference Room)

12:00 Lunch or Departure

Departure Times Dr. Zimmerman flight 2:25 Dr. Kahn Delta 4338 4:55 pm

Table of Contents

A) History of Program Reviews of University of Florida College of Pharmacy Graduate Review

B) Pharmaceutics Self Study Report

Appendixes

1) Faculty CV’s 2) Adjunct Faculty Listing 3) Departmental Graduate Courses 4) Description of the Pharmaceutics Graduate Program 5) Description of the Clinical Pharmaceutical Sciences Ph.D Program 6) Survey Results of Currently Enrolled Graduate Students 7) Survey results of Alumni of Pharmaceutics Graduate Program

Other Items Link to 2008 Research Showcase This is a online video showcasing a few of our students to give you an introduction to some of the exciting research in the graduate program. http://pharm.digiscript.net/B33/550054/player.HTM#

History of Program Reviews of University of Florida, College of Pharmacy Graduate Programs:

Although graduate education was first established in the College in the mid 1920’s (see below: Graduate Programs in the College of Pharmacy), it was not until 1989 that the first comprehensive, self-study with external review of graduate programs within the College was initiated. The initial review was completed in 1990 whereby overall assessment of graduate faculty, students and physical resources in the College, Health Science Center and University of Florida were reviewed. The external review committee met with each program in April of 1990 and prepared a single summary report that was sent to the Dean of the College. Briefly, this report noted that overall the graduate programs in the college were of good quality. However, the college needed to pay particular attention to five areas: (1) interdepartmental interactions and multidisciplinary activities; (2) acquisition of additional research space; (3) improvement of College/graduate School interactions; (4) support of graduate students; and (5) recruitment of faculty into areas of research strength and emerging areas of research with in the Pharmaceutical Sciences. The Dean appointed a Faculty Task Force to study the issues raised by the 1990 external report. The Faculty Task Force prepared a brief report that was presented at the College’s 1990 summer faculty retreat. In 1993 the College conducted a second “internal” self study process of the graduate programs. The overall charge of this review was four-fold (1) review each of their departmental mission statements; (2) review respective graduate programs since the 1990 review; (3) appraise departmental graduate program strengths and weaknesses; and (4) describe their respective vision of their graduate programs for the year 2000 and outline a plan to achieve that vision. A summary of the internal review was prepared and submitted to the College faculty in October 1993. Graduate programs within the College have not undergone any organized self-study with either external or internal review since 1993.

Process, Guidelines and Timelines for the Current Review of Graduate Programs in the College:

In 2006, the Florida Board of Governors mandated that the University of Florida and all 10 other SUS Universities in Florida conduct program reviews every seven years to provide continuous quality improvement of programs and to meet accreditation cycles of the respective institution. Both undergraduate (baccalaureate) and professional degree programs were targeted by this initial 2006 mandate. However, in 2007, SUS Universities were notified that the seven-year review of programs was extended to graduate programs as well, thus requiring UF colleges to conduct the current review. The UF-College of Pharmacy was sent Guidelines to incorporate as they see fit into their individual program reviews. The Dean of the College of Pharmacy, Dr. William H. Riffee, required that each graduate program review should be independent of each other and conducted by external committees consisting of a minimum of three external reviewers. The respective departments were charged with selecting and inviting faculty from peer institutions to serve in this capacity. Dr. Anthony Palmieri, Assistant Professor in Pharmaceutics was asked to serve as the coordinator of the Graduate program reviews. In this capacity, Dr Palmieri established the program review timeline and was involved in preparing program surveys for: current graduate faculty/departmental current graduate students graduate alumni (dating back as far as 10-12 years)

The goal was to make each survey as comprehensive as possible, but to minimize the number of questions and restrict answer format to maximize brevity for the person asked to complete the respective survey. In following, each of the surveys generated were web-based and synthesized from survey templates from multiple sources, including the American Association of Colleges of Pharmacy; peer institutions and health center colleges within the University of Florida. Departments and members of the College’s Graduate Studies Committee reviewed the surveys multiple times through out survey development to prepare the final formats. All surveys were submitted to the respective groups in early October, 2007 with a target completion date of November 15, 2007 to allow time for the respective departments to prepare their self study reports. In addition to the surveys, each department was given a 10-11 year history file prepared by the College’s Office for Research and Graduate Studies (ORGS) containing respective graduate student information, including entering credentials, stipend levels, and graduation statistics. Department’s were also recommended to gather pertinent and any additional student information from ORGS annual report website to complete their self-study document. Information from the above two sources (surveys and student informational data) as well as a narrative of the history of graduate program reviews in the college including peer institutional date were used to complete the final self study report from each department. The finalized departmental self-study report was sent to the outside review teams in mid January with March/early April dates established by the respective departments for the respective site visit teams to visit UF to conduct their two-day review. Review teams were asked to submit their final 3-5 page reports to the College by mid-May so that college can prepare and submit the final report for all graduate programs to University Administration and the State of Florida Board of Governors by July 1, 2008.

Overview of Administrative Structure of the University of Florida with Respect to Graduate Education:

An abbreviated University of Florida Administrative Organizational Chart is outlined below (Figure 1).

Figure 1: Administrative Flow Chart for the University of Florida

University of Florida Board of Trustees

Dr. J. Bernard Machen President

Dr. Jimmy G. Cheek Dr. Janie M. Fouke Dr. Douglas J. Barrett Dr. Kyle Cavanaugh Senior Vice President for Agriculture Provost and Senior Vice President for Senior Vice President for Health Senior Vice President for and Natural Resources, IFAS Academic Affairs Affairs Administration

Dr. Henry T. Frierson Dr. William H. Riffee Dean, Graduate School Dean, College of Pharmacy

A detailed description of the organizational structure for the University can be found at: Statement of Organization and Operation. Briefly, the UF Board of Trustees (BOT) sets policy for the University and serves as the Institution’s legal owner and final authority. The President is appointed by the BOT and the institution’s chief executive officer and is responsible for the general administration of all university activities. Reporting to the President are four Senior Vice-Presidents: (1) the Provost and Senior Vice for Academic Affairs; (2) Senior Vice President for Agriculture and Natural Resources; (3) Senior Vice president for Health Affairs and (4) Senior Vice President for Administration. As the College of Pharmacy is one of the six professional degree colleges within the Heath Science Center at UF, its Dean, Dr. William H. Riffee reports directly to the Senior Vice President for Health Affairs for all matters relating to the academic mission of the professional degree programs in the College. Graduate education at the University of Florida is administered through the Graduate School. The organizational chart of the Graduate School is found on the following page (please see, Figure 2). Because research is a primary foundation upon which graduate education is built, the Graduate School is, in fact, a major component of the Office of Research at the University of Florida. Dr. Henry Frierson, Associate Vice-President and Dean of the Graduate School is responsible for administration of all graduate degree programs and reports directly to the Provost and Senior Vice President for Academic Affairs.

Figure 2: Organizational Chart for the University of Florida Graduate School

Dr. Henry Frierson Associate Vice President Dean of the Graduate School

Dr. Kenneth Gerhardt Associate Dean for Academic Affairs

Dr. Laurence B. Alexander Dr. Karen Bradley Interim Associate Dean Associate Director Graduate Minority Programs

Mr. Earl Wade Ms. Gann Enholm Coordinator Coordinator Graduate Minority Programs Graduate Student Records

Ms. Janet Broiles To Be Announced Coordinator Coordinator Recruitment & Retention Data Management

Ms. Anne Taylor Coordinator Editorial .

The Mission, Vision and Organization of the University of Florida Graduate School are outlined below: Graduate School Mission:

Graduate education is an integral component of a major research university that impacts education at all levels. The mission of graduate education at UF is to produce individuals with advanced knowledge in their fields, who appreciate learning and are constant learners, and who are prepared to address creatively issues of significance to the local and global community for improving the quality of life. Essential to this mission is an environment that fosters

Effectively transmitting knowledge for future generations. Inquiry and critical analysis. Assimilation and creation of new knowledge. Skills contributing to success and leadership in academic and creative arenas and in the world of practice. Applying that knowledge in service to Florida, the nation, and the international community.

Graduate School Vision

The vision is a university internationally recognized for its graduates, Graduate Faculty, and scholarly achievements. This university produces intellectually energized individuals who excel at future careers in diverse settings, and who provide bold leadership in new directions. Important signs of this recognition include: Graduates recognized for strength of preparation in their chosen discipline, for abilities to solve problems in new environments, and for high standards of excellence in scholarly activity and professional practice. Significant scholarly, creative achievements and service that contribute to improvement of human society and the natural environment. A highly qualified, diverse student population. Strong disciplinary and interdisciplinary programs that prepare graduates to assume their roles in a changing world. Evidence of service in their disciplines by students and faculty at state, national, and international levels.

Graduate School Organization:

The Graduate School consists of the Dean, Associate Deans, Graduate Council, Council of Graduate Deans, and the Graduate Faculty (see above Figure 2) . General policies and standards of the Graduate School are established by the Graduate Faculty. Any policy change must be approved by the graduate dean(s) and the Graduate Council. The Graduate School is responsible for enforcing minimum general standards of graduate work in the University and for coordinating the graduate programs of the various colleges and divisions of the University. Responsibility for detailed operation of graduate programs is vested in individual colleges, schools, divisions, and academic units. In most colleges an associate dean or other administrator is directly responsible for graduate study in that college. The Graduate Council helps the Dean in being the agent of the Graduate Faculty for executing policy related to graduate study and associated research. The Graduate Council (chaired by the graduate dean) considers petitions and policy changes. The Council of Graduate Deans has also been established by the Dean as an advisory group and forum by which respective graduate deans can discuss graduate education policies in an open, university-wide setting. A graduate program’s academic unit appoints members of the Graduate Faculty, with approval of the graduate dean. All faculty members who serve on supervisory committees or who direct master’s theses and doctoral dissertations must first be appointed to the Graduate Faculty. The academic unit determines the level of duties for each Graduate Faculty member.

Graduate Programs in the College of Pharmacy

The College of Pharmacy (COP) was established in 1923 as a school to train future practitioners in the profession of Pharmacy for the State of Florida. In 1925, the College initiated the graduate program for the Master of Science in Pharmacy (MSP). Subsequently, in 1930, the COP admitted the University of Florida’s first doctoral (PhD) degree student into their Doctor of Philosophy with a Major in Pharmacy program. The Doctor of Philosophy with a Major in Pharmacy degree program was subsequently changed to a doctoral program in Pharmaceutical Sciences in 1932. Both the PhD in Pharmaceutical Sciences and Master of Science in Pharmacy programs and degrees remain in effect to this day. Noteworthy is that in 1934, the first PhD degree awarded by the University of Florida was in Pharmaceutical Sciences and was awarded to Dr. I.J. Klotz. Graduate Education remains a core function of the University of Florida, College of Pharmacy as outlined in the college’s Mission Statement:

Mission Statement of the College of Pharmacy

The University of Florida, College of Pharmacy promotes the health and welfare of the citizens of Florida and the Nation by preparing graduates in Pharmacy to take independent professional responsibility for the outcome of drug therapy in patients. Graduates have the scientific and cultural background necessary to assume leadership roles in the profession and the community. The College promotes and fosters graduate education in the Pharmaceutical, Clinical, Administrative and Psychosocial sciences. The College educates students to be distinguished contributors to Pharmacy and related disciplines. The College provides faculty members the opportunity to develop fully as teachers and scholars. The College supports development of quality research programs, which serve to advance the knowledge and skills of pharmacists, other health care professionals and the associated scientific community. The College provides leadership for the continuing professional growth and development of Pharmacy in Florida, nationally, and internationally. The College cooperates in a service capacity with other institutions in the provision of specialty advanced training, as well as with the state and the profession in areas where the College Faculty possess unique expertise. The College provides opportunities for practicing pharmacists to maintain and enhance their competencies for professional practice.

Under the umbrella of the PhD in Pharmaceutical Sciences there are currently four graduate concentrations that are recognized in the College of Pharmacy by the Graduate School. These graduate concentrations are: Medicinal Chemistry (recognized in 1978), Pharmacodynamics (recognized in 1989), Pharmacy Health Care Administration (recognized in 1996), and Pharmaceutics (recognized in 1998). Because of the growing need to have clinically-trained individuals who also have sufficient research training to conduct bench–to-bedside (translational) research, the Departments of Pharmaceutics and Pharmacy Practice developed a collaborative Clinical PhD track within the Pharmaceutics graduate program in the fall of 2004. This Clinical Pharmaceutical Sciences Program is geared to prepare motivated individuals to pursue independent clinical research careers in academia, industry or government. Tied to each of the PhD programs in the College is an associated Master of Science in Pharmacy (MSP) Program. The MSP program in the departments of Medicinal Chemistry, Pharmaceutics, and Pharmacodynamics requires each student to prepare and defend a thesis as part of their degree. The Pharmacy Health Care Administration Department has the option of a thesis or non-thesis M.S. degree. In general, students are discouraged from entering directly into an MSP program; instead, students are strongly encouraged to enter into one of the PhD programs. However, students may opt for the MSP. degree in their discipline if they find that the PhD degree is not what they desire (see below: Graduate Degrees Awarded in the College). During FY 1991/1992 all Graduate Studies/Programs were decentralized in the College from the Office of Research and Graduate Studies (ORGS) and into each of the individual departments. With this decentralization the review or setting of graduate policies and graduate student recruitment is now in the hands of the individual departments. To assist the ORGS in the management of graduate activities in the College, the Graduate Studies Committee (GSC) was established.

Office of Research and Graduate Studies in the College.

The Office of Research and Graduate Studies (ORGS) was established in the College of Pharmacy (COP) in 1989 as the major unit within the College responsible for the oversight of all aspects of the graduate programs as well as research activities. Within the purview of these two major activities are a number of functions that are coordinated by ORGS personnel and make up the daily operations of the office. The structure of the ORGS is outlined in Figure 3 (please next page). Dr. William Millard, Professor in the Department of Pharmacodynamics, accepted the role as Associate Dean for Research and Graduate Studies on an acting basis in January 1995, and then on a permanent basis in August 1997. On January 1, 1999, Dr. Millard accepted the permanent position as Executive Associate Dean for the College of Pharmacy and as part of this position maintains oversight of the ORGS and reports all ORGS activities directly to the Dean of the College. The Executive Associate Dean is responsible for monitoring all graduate student applications, quality of graduate students and the progression of students through the graduate programs in the College. The Executive Associate Dean's role also includes monitoring of the quality of graduate programs and seeking ways to expand or improve graduate education within the COP. The Executive Associate Dean also acts as the major liaison between the Office of Research (see below) at the University of Florida and the COP faculty and graduate students. To facilitate this activity the Executive Associate Dean sits on the Council of graduate Deans that is integral in facilitating policy within the Graduate School at the University of Florida (see above: Organization of Graduate Education at the University of Florida).

Figure 3: Administrative Flow Chart for the ORGS

Anthony Palmieri, Ph.D. William Millard, Ph.D. Grad. Prog. Rev. Coord. Executive Associate Dean William Riffee, Ph.D. Dean, College of Pharmacy Raymond Bergeron, Ph.D. Grad. Coord., Medicinal Chemistry

Deborah Stowell Jeffrey Hughes, PharmD., Ph.D. Program Assistant Grad. Coord.,Pharmaceutics

Joanna Peris, Ph.D. Grad. Coord.,Pharmacodynamics

Carole Kimberlin, Ph.D. Grad. Coord., Pharmacy Health Care

Reginald Frye, PharmD., Ph.D. Grad. Coord., Pharmacy Practice

Information concerning graduate programs and education within the COP is communicated from the Executive Associate Dean to faculty or graduate students through the Departmental Chairs and Graduate Coordinators. The Graduate Studies Committee and COP Graduate Student Organization assist the Executive Associate Dean in the responsibility of governing graduate education in the COP (see below: Graduate Studies Committee and College of Pharmacy Graduate Student Organization). The Executive Associate Dean is assisted in the ORGS by a Program Assistant. Since June 2001 the ORGS Program Assistant has been Ms. Deborah Stowell. The Program Assistant’s role is to handle the daily operations of the ORGS. This includes the submission of needed reports to the COP, University and outside agencies. Communication of informational items to the faculty and graduate students related to issues of graduate education is also a responsibility of the Program Assistant as well as dealing individually with graduate students and assisting them with various problems and graduate course registration.

Graduate Studies Committee (GSC)

The primary goal for the GSC is to be a medium through which graduate and research programmatic goals are reviewed on a continual basis and aligned with the goals of the College and the University (i.e., continuous quality improvement, CQI). The primary charge of the GSC is to review and make recommendations on graduate programs in the College of Pharmacy. This would include both new and existing graduate programs. The GSC is involved in considering how the College can attract/fund more graduate students with an emphasis on bringing in more U.S. students and professional (pharmacy) students. This committee is also involved in reviewing any future major mandate(s) from the Graduate School that may impact the functioning of the overall graduate program within the College (i.e., stipends; tuition waivers). The committee continues to select finalists in the College’s Spring Research Competition and also makes recommendations on how to improve this College function. The makeup of the GSC includes graduate coordinator representatives from each of the departments and the President of the COP Graduate Student Organization. Beginning April 2007, Dr. Anthony Palmieri, Clinical Assistant Professor in the Department of Pharmaceutics, was asked to join the GSC to head-up the College's graduate program review. The Executive Associate Dean serves as the non-voting chair, and the Dean as ex-officio member of the committee. The Program Assistant sits in on all committee meetings as the recording secretary. Representatives on the Graduate Studies Committee are:

Non-voting Chair: Dr. William Millard Office of Research and Graduate Studies Non-voting Secretary: Ms. Deborah Stowell Office of Research and Graduate Studies

Voting Members: Dr. Raymond Bergeron Medicinal Chemistry Dr. Joanna Peris Pharmacodynamics Dr. Carole Kimberlin Pharmacy Health Care Administration Dr. Jeffrey Hughes Pharmaceutics Dr. Tony Palmieri Pharmaceutics Dr. Reginald Frye Pharmacy Practice Ms. Matthais Fueth President of COP Graduate Student Organization.

Ex-officio Member: Dr. William Riffee Dean

The GSC meets monthly throughout the academic year. Some of the issues that are routinely deliberated include:

Selection of the new Alumni Scholarship Awardees. Review of the use of Liberty Award monies for graduate students in each of the 4 Ph.D. granting departments. Use of State Line OPS monies for graduate student stipends. Establishment of TA assignments for each of the semesters. Establishment of goals and objectives for each graduate program within the College. Selection of finalists for the College’s Annual Research Showcase and Awards Recognition Day. Preparation for external review of each of the four graduate specialties in the College.

College of Pharmacy Graduate Student Organization.

The COP Graduate Student Organization (GSO) is an avenue by which graduate students can discuss common issues related to graduate education and bring their concerns to the attention of the Executive Associate Dean for Research and Graduate Studies. The COP GSO elects a president on an annual basis. The president of the organization coordinates and runs the meetings (1-2 per year) and also sits in on the Graduate Studies Committee as a voice for the graduate students. Mr. Matthias Fueth, from the department of Pharmaceutics, currently serves as president of the organization. At the beginning of each Fall and Spring term, the ORGS sponsors a luncheon for COP graduate students to promote a forum for exchange of information between each other and the ORGS.

College’s Strategic Plan and Graduate Education

In response to the recommendations of the Accreditation Council for Pharmacy Education (ACPE) based on the College’s self-study of its Professional Degree Programs in January 2007, the College has begun to update its Strategic Plan. In following, the faculty and staff of the College met in St. Augustine, FL on May 17-18, 2007 to begin the process. The Research and Graduate studies focus group identified two goals for the short- and long-term improvement of the College’s graduate program.

1. Increase critical mass of graduate students in graduate programs and

2. Increase graduate student stipend levels.

Although we are still at a preliminary stage in the overall process, we have identified steps and specific targets for each of the two goals. For Goal #1, the primary target is to reach a level of 3-6 students per tenure track research-intensive faculty; or a total of 110 graduate students in the college graduate programs. The College’s faculty and administration realize that we will have to take active steps to increase the number and funding levels of the endowed graduate student and post-doc lines. The second goal is related to the first in that to increase the critical mass, we will need to increase graduate student stipends to become competitive with peer colleges and universities (see below Peer Institutional Comparisons). The College will need to increase our efforts in philanthropic giving, extramural support dollars, and developing legislative budget requests for specific activities that would support graduate students during their education.

Graduate Degrees Awarded in the College

The total number of graduate degrees (Masters of Science in Pharmacy (MSP) and PhD) awarded by decade in the College can be found in Table 1. It is evident that over time the PhD degree has been the primary degree awarded in the college with 67.7% of all graduate degrees awarded a doctorate in Pharmaceutical Sciences. Doctoral training has become very active in the college since 1990 with over half (162 of 314; 51.6%) of all PhD degrees awarded in the college during this period. Over this same time-period, the number of MS degrees (29 of 150; 19.3%) has diminished, owing to the fact that each of College’s graduate programs recruits students only into their respective PhD programs. In general, MSP degrees are awarded to those students who opt out of the PhD track while in a given graduate program.

Table 1: Graduate Degrees Awarded by Decade Decade MSP PhD Total 1920-1929 2 0 2 1930-1939 12 5 17 1940-1949 11 4 15 1950-1959 22 43 65 1960-1969 14 21 35 1970-1979 34 22 56 1980-1989 26 57 83 1990-1999 15 74 89 2000-2007 14 88 102 Total 150 314 464

Table 2 illustrates further the numbers of MSP and PhD students awarded by year in the College since Academic Year (AY) 1996-1997. Again, the PhD degree is the preferred degree awarded in the College during this time period with 87% of the degrees conferred being doctoral degrees.

Table 2: Graduate Degrees Awarded by Year Academic Year* MS PhD Total 1996-1997 3 6 9 1997-1998 1 11 12 1998-1999 0 15 15 1999-2000 0 11 11 2000-2001 1 9 10 2001-2002 5 12 17 2002-2003 1 5 6 2003-2004 0 12 12 2004-2005 2 16 18 2005-2006 4 10 14 2006-2007 1 14 15 Total 18 121 139 *Academic year = begins July 1 and ends June 30 of following year

Graduate Survey

To assess the quality of the graduate programs in each department, two surveys were constructed; one for graduates where there was a valid e-mail address and one for currently enrolled graduate students. College wide, there were 59 responses total for alumni. Thirty percent are currently in a faculty position. Forty-five percent of the alumni entered a post-doc experience upon graduation. Of those responding the positives of their UFCOP experience they mentioned included mentoring, publishing, advising and the research environment. The major lack in their education, as they view it, is that lack of opportunity to learn about grant writing and how to be successful in writing grant applications. They believed that obtaining a graduate degree made a significant difference in their career. Almost ninety percent of the respondents were satisfied with their education and that enrolling at UFCOP was a good decision.

Sixty-three currently enrolled graduate students responded to the survey. The average time in the program was two years. Half of the students are most interested in an industrial position. Ninety percent chose UFCOP because of the academic reputation of the programs. Almost seventy percent thought that the level and breadth of the academic offerings were high as well as the level of instruction. The only area of disappointment appears to be the level of the stipend. This is not surprising given the comparator school data.

Peer Institutional Comparisons

To discern where the University of Florida, College of Pharmacy is positioned with regard to other comparable institutions, graduate program data from 14 other schools having comprehensive doctoral (PhD) programs. The schools and programs identified were geographically diverse, and usually do compete for similar students to those that attend UF. The summative data presented in Table 3 represent for academic years 2002-2003 through 2005-2006 (4-year comparisons) for all indices except for # of graduate students and average graduate student stipends. The number of graduate students and student stipends are identified for academic years 2004-2005 and 2005-2006 only. Also please note that not all data was provided by all schools as indicated by the yellow-shaded cells.

The University of Florida, College of Pharmacy compared very favorably in nearly all academic categories noted in the Table (student qualifications, number of students, student-faculty ratios, time-to- degree (TTD), and placement of graduates). The one area of concern is that of the average graduate stipend. The UF-COP average stipend is second to the lowest of all comparator schools. While it is admirable that UF COP compared favorably with the other schools, it is critical that the University do all that is possible to increase the average stipend amount. If this stipend does not compare favorably with other schools, we may find that we are loosing students to other comparable institutions.

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Self-Study of the Pharmaceutics Graduate (Ph.D.) Program, Spring 2008

The objectives of the Ph.D. program in the Department of Pharmaceutics are:

1 To provide a foundation in the pharmaceutical sciences in general, as well as in the specific tracks identified, with emphasis on pharmacokinetics, biopharmaceutics, pharmaceutical analysis, pharmaceutical technology/drug delivery, pharmacodynamics, pharmaceutical biotechnology, pharmacogenomics, translational research and drug design and discovery.

2 To educate individuals capable of conducting independent research and with in-depth specialized knowledge in one of the above areas and to provide a solid educational, technical and experiential foundation for students in the industrial, academic, governmental or other arenas.

3 To provide an environment that nurtures and stimulates the research interests and the intellectual advancement of students and faculty, including a forum for scientific and professional discussion.

Department of Pharmaceutics The Department of Pharmaceutics is located in the University of Florida, J. Hillis Miller Health Center, 1600 SW Archer Rd., a complex that includes the Colleges of Pharmacy, Medicine, Nursing, Health Related Professions, Dentistry, and Veterinary Medicine, Shands Hospital, and is in close proximity to the Veterans Administration Medical Center. The variety of disciplines in the health science complex guarantees a stimulating scientific environment.

The Department of Pharmaceutics at the University of Florida has an extensive, externally supported research program. Research in the Pharmaceutics Department encompasses basic, applied, and clinical investigations in (i) pharmacokinetics/ pharmacodynamics, (ii) pharmaceutical analysis, (iii) gene and drug delivery, and (iv) herbal medicine. The Department has the responsibility for teaching Pharmaceutics to first through fourth year pharmacy students. The Department has a Ph.D. degree-granting graduate program in Pharmaceutics. Its Faculty members participate in several interdisciplinary Ph.D. programs. Faculty of the Department train and teach Residents and Fellows and offer required and elective courses for pharmacy and Ph.D. graduate students. In addition to teaching, all faculty members are involved in collaborative research projects with clinical and other basic scientists within the Health Center or on campus. Many maintain collaborative ties with scientists in other universities and the pharmaceutical industry worldwide.

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The Department of Pharmaceutics graduate faculty are listed below (CV’s are provided in Appendix 1) and the adjunct faculty are in Appendix 2

Faculty and Staff Pharmaceutics Graduate Faculty

Graduate Research Professor Nicholas Bodor, Ph.D.

Full Professor Hartmut Derendorf, Ph.D. Julie Johnson, PharmD, FCCP, BCPS Leslie Hendeles, PharmD Guenther Hochhaus, Ph.D. Mike Scwhartz, Ph.D.

Associate Professor Sihong Song, Ph.D. Reggie Frye, PharmD, Ph.D.

Assistant Professor Veronia Butterweck, Ph.D. Amber Beitelshees, Pharm.D. Issam Zineh, PharmD

Research Assistant Professor Rhonda Cooper-DeHoff, PharmD, MS Taimour Langaee, MSPH, Ph.D.

Clinical Associate Professor Cary Mobley, Ph.D. Tony Palmieri, Ph.D.

Dr. Derendorf serves as Department Chair of Pharmaceutics and Dr. Johnson is Department Chair of Pharmacy Practice. Dr. Hughes and Dr. Frye serve as Graduate Coordinators for Pharmaceutics and Pharmacy Practice, respectively.

Faculty research and scholarly activities

The faculty members are actively engaged in research and supervision of graduate students. External research funds are obtained from the pharmaceutical industry, research foundations and the federal government funded by external funding agencies including NIH, the American Diabetes Foundation, American Heart Association, Florida Department of Health and the Pharmaceutical Industry, Table 1.

Table 1. Departmental Research Dollars Pharmaceutics Pharmacy Practice 2006-2007 $1,426,989 $2,752,560 2006-2005 $1,532.052 $3,241,370 2005-2004 $1,099,022 $1,348,430 3

Departmental faculty actively participate in multiple professional activities including serving on review panels for national and international grant review panels. One faculty member is a full member of NIH study sections and other faculty members have served as ad-hoc members of study sections in the past five years. Several faculty members are currently or have recently been members of the editorial boards of journals in the biomedical or pharmaceutical sciences (Derendorf, Palmieri, Hochhaus, Butterweck, and Hughes). All faculty members publish their research and are well cited.

All of the departmental faculty members teach in the professional pharmacy curriculum and all faculty members participate in didactic graduate courses. (The courses are listed in Appendix 3

Facilities

The departments occupy laboratories in the P-wing in the Health Science Center. The department has state of the art bioanalytical instruments including a LC-MS- MS, pharmacogenomics instruments, along with facilities for conducting synthetic chemistry, molecular biology and animal studies. Each research faculty also has specialized instruments for his or her own research.

Ph.D. program description.

The admission policies and general description of the graduate program is given in Appendix 4. The Ph.D. in the Clinical Pharmaceutical Sciences is provided in Appendix 5.

Sources of stipend funding All students in the Pharmaceutics pre-doctoral program are awarded a stipend and tuition waiver. The College of Pharmacy currently (2007-8) provides the department with funds for 16 teaching assistantships. The base stipend is $14,500. Well qualified students are eligible to compete for an additional $3,000 per year for the first three years through the Grinter scholarship program. Extremely well qualified students can compete for an Alumni scholarship, which in 2007 carried a stipend of $22,500 + tuition. In addition we have six industrial supported graduate lines from Pfizer and Merck. In the past five years some students have been supported (tuition and stipend) through a training core funded by NIH Training grant. Graduate students in the Clinical Sciences program have the option of working part time at UF/Shands hospital for higher stipends.

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Graduate Student Recruitment Activity. Table 2 provides a snap shot of recent recruitment activity of the department. The average GRE score of accepted students was 1220 for the past 5 years.

Departmental Graduate Student Recruitment Activity # # Completed # Applications % Applicants %

Department # of Requests Applications Accepted Accepted Entered Entered Pharmaceutics 07/08 N/A 83 8 9.6% 8 100.0% Pharmaceutics 06/07 N/A 100 5 5.0% 3 60.0% Pharmaceutics 05/06 186 111 21 18.9% 16 76.2% Pharmaceutics 04/05 169 98 9 9.2% 6 66.7% Pharmaceutics 03/04 315 134 5 3.7% 3 60.0% Pharmaceutics 02/03 431 96 9 9.0% 6 67.0%

Careers of graduates

The department does not offer formal career guidance, but leaves it up to each faculty member to advise his or her students of the opportunities available. The department does not formally track the careers of our graduates, but faculty mentors encourage them to keep in touch. Table 3 provides information concerning some of our recent graduates and their first position.

5

Table 3

Graduates LAST FIRST Date Left WORKNAME Arya Vikram 9/1/2003 FDA Coowanitwong Intira 12/30/2003 Chrysalis Technologies Incorporated Driessen Wouter 5/1/2007 M.D. Anderson Cancer Center Gong Yan 5/1/2004 Pharmacogenomics, UF, Grundmann Oliver 12/14/2007 University of Arizona Hirko Aaron 8/1/2006 University of Pittsburg Iyengar Adarsh 8/4/2004 Dismissed Khunvichai Ariya 12/30/2003 Hoffmann La Roche Liu Ping 12/30/2002 Groton Laboratories, Pfizer Inc. Liu Qi 5/1/2004 FDA Napaporn Jintana 6/1/2002 Professor, Thailand Nguyen Vien 6/1/2006 Phebus Kathryn 7/1/2002 Withdrawn Ren Ke 12/31/2005 FDA Sahasranaman Srikumar 8/1/2004 Novartis Pharmaceuticals Corp. Sarawek Sasiporn 9/30/2007 Lexicon Schuck Virna Josiane Aurelio 12/30/2004 Astrazenica Schuck Edgar 12/30/2004 Eisai Tang Mei 8/30/2006 Merck Tiab Zia 9/30/2006 Dismissed Toussaint Nathalie Y 5/1/2007 Bristol Meyers Squibb Wang Yaning 8/30/2003 FDA Winkler Julia 7/1/2004 Jerini AG Wu Kai 12/30/2006 Novartis Yadava Preeti 5/1/2007 Philadelphia College of Pharmacy Zhu Hao 8/4/2004 FDA

Survey Assessment of Current Students and Alumni

A survey was also conducted of all current students and alumni. The response to these general questions are provided in Appendix 6 for the current students and in Appendix 7 for the Alumni. 6

Program assessment

The department faculties meet and discussed our current graduate program and where we see us progressing over the next few years.

The department perceives the following strengths. We continue to have an excellent reputation in the area of pharmacokinetics and pharmacodynamic modeling. The majority of the current students are working in these disciplines. The department continues to grow its recognition in the fields of drug delivery, herbal medicine and gene delivery. The department decided that new faculty hires and resources should be deployed in these research areas to continue to grow and national and international reputation. A recent new strength is also the Ph.D. in clinical sciences while this is a relative new program it has already grown to be one of the largest. The program recruits from students in our own Professional Pharmacy Program as well as external students. A description of this program is provided in Appendix 4.

Ability to recruit students continues to be a major strength of the department. We consistently have 80-90 applicants for around 4 openings per year. A high number of applicants allows for the selection of outstanding students to grow our program. The applicant pool is very diverse with 70% coming from international students and about 50% of the applicants having a pharmacy degree.

The infrastructure of the University of Florida continues to be a major strength of the department both for research efforts of the faculty and the recruitment of students. New University initiatives will continue to strengthen our graduate program. In particular the Genetics institute (www.ufgi.edu), the Particle Engineering (www.perc.ufl.edu) Research Center, Nano technology center, the Biomedical Engineering (www.bme.ufl.edu) and the clinical research center (www.gcrc.ufl.edu) all play important roles in the departmental research focus.

The alumni from the department remain a strength of the department. They are an unexpected source of recruitment of new students; they also provide industrial rotation sites for our current students as well as financial support for conducting research within the department.

Departmental Weaknesses

We also discussed weakness of the department both internal and external. External weaknesses have resulted from budgetary restraints. Currently, we have two open faculty lines. These vacancies have limited our potential to grow over the past few years. To offset a portion of this problem the college has increased support for the teaching mission of the department (hiring new faculty for teaching) which has maintained the current lecture load to around 40 hours per year of pharmacy education and about 20 hours of graduate classes per 7 year. This teaching intensive faculty has allowed the more research based faculty to continue their high productivity. The increased difficulty in obtaining Federal research funds in the current environment will continue to face the department over the next few years and will continue to be a potential weakness

CURRICULUM VITAE

NICHOLAS BODOR

Date of Birth: February 1, 1939

Address: 10225 Collins Avenue, Apt. 1002/1004 Bal Harbour, FL 33154

Telephone: (305) 868-8250 (residence) (305) 575-6028 (office)

Married To: Sheryl Lee Bodor

Children: Nicole, Erik

Education: Diploma in Science (B.S., M.S., Organic Chemistry) with special honors; straight A's throughout the five years, Bolyai University, Cluj, Romania, 1959

Doctor in Chemistry Babes-Bolyai University, and Supreme Council of Scientific Titles of the Romanian National Academy of Science, 1965

R.A. Welch Postdoctoral Fellow University of Texas at Austin, 1968-1969; 1970-1972

Employment Positions:

Present: Chief Scientific Officer IVAX Corporation 4400 Biscayne Blvd. Miami, Florida 33137 (April 2003-present)

Managing Director IVAX Drug Research Institute, Ltd. 47-49 Berlini Street, H-1045 Budapest, HUNGARY (October 1999-present)

President IVAX Research Institute, Inc. 4400 Biscayne Blvd. Miami, Florida 33137 (September 2002-present)

Senior Vice President Basic Research and Drug Discovery IVAX Research, Inc. 4400 Biscayne Blvd. Miami, Florida 33137 (February 2000-present)

Executive Director Center for Drug Discovery College of Pharmacy, P.O. Box 100497 J. Hillis Miller Health Center University of Florida, Gainesville, FL, 32610 1990-present

Graduate Research Professor Emeritus (active) Department of Pharmaceutics College of Pharmacy University of Florida, Gainesville, FL 32610

Affiliate Graduate Research Professor Department of Ophthalmology College of Medicine J. Hillis Miller Health Center University of Florida, Gainesville, FL, 32610, 1991-present

Former: Graduate Research Professor Departments of Medicinal Chemistry (1983-2003) and Pharmaceutics (1991-2003) College of Pharmacy University of Florida, Gainesville, FL, 32610

V Ravi Chandran PhD Professor in Drug Design and Targeting College of Pharmacy University of Florida, Gainesville, FL, 32610 2000-2003

Vice President and Director, Pharmatec, Inc. Alachua, FL, 32615, 1983-1992

Director Center for Drug Design and Delivery Box J-497, J. Hillis Miller Health Center University of Florida, Gainesville, FL, 32610, 1986-1990

Chairman Department of Medicinal Chemistry College of Pharmacy J. Hillis Miller Health Center University of Florida, Gainesville, FL, 32610, 1989-1990

Professor (1979-1983) and Chairman (1979-1984) Department of Medicinal Chemistry J. Hillis Miller Health Center University of Florida, Gainesville, FL, 32610

Associate Director of Medicinal Chemistry INTERx Research Corporation, Lawrence, KS, 1973-1979

Adjunct Professor of Pharmaceutical Chemistry University of Kansas, Lawrence, KS, 1978-1980

Adjunct Professor of Medicinal Chemistry University of Kansas, Lawrence, KS, 1974-1978

Senior Research Scientist ALZA Corporation, Lawrence, KS, 1972-1973

R.A. Welch Postdoctoral Fellow, 1968-1969; 1970-1972 University of Texas at Austin, TX

Principal Investigator and Group Leader Chemical-Pharmaceutical Research Institute Cluj, Romania, 1961-1968; 1969-1970

Research Investigator and Group Leader "1 September" Factory, Satu Mare, Romania, 1959-1961

Honors, Fellowships: National Scholarship for Outstanding Achievement, 1954-1959

Various honors and awards for undergraduate research

Diploma of Honor (straight A's for five years)

R.A. Welch Fellowship (two occasions, 1968-1969; 1970-1972)

The Nagai Foundation Tokyo Fellowship 1994

Listed in: Who's Who in America Who's Who in Science and Technology Who's Who in Frontiers of Science Who's Who in Technology Today Who's Who Worldwide (Platinum Edition) Ki Kicsoda (Who's Who Worldwide--Hungarian Edition) American Scientist

Elected to:

Fellow, Academy of Pharmaceutical Research and Science, 1983

Fellow, American Association of Pharmaceutical Scientists, 1986

Fellow, American Association for the Advancement of Science, 1989

Honorary Member, Hungarian Chemical Society, 1988

Honorary Member, Panhellenic Association of Pharmacists, 1989

Fellow, American College of Clinical Pharmacology, 1991

Hungarian Academy of Sciences, 1995

Elected Member, Dermatology Advisory Board, Glaxo Wellcome, 1997

Fellow, the World Innovation Foundation, 2002

Name Lectureships:

Hoechst-Rousell Lectureship in Chemistry, Somerville, NJ, 1983; Hoshi University Diploma, Tokyo, Japan, 1983; Bombay College of Pharmacy Silver Medal, Bombay, India, 1984; Nichols Distinguished Symposium, American Chemical Society, Tarrytown, NY, 1986; Sigma Xi Lectureship, 1987; The Högyes Lecture, Semmelweises Univ. of Medicine, Budapest, Hungary, 2000.

Awards: University of Florida Graduate Research Professor in 1983

"The 1984 Florida Scientist of the Year"

AAPS Research Achievement Award (the first) in Medicinal and Natural Product Chemistry, 1988

APhA Research Achievement Award in Pharmaceutical and Medicinal Chemistry, 1989

University of Florida Research Achievement Award, 1990

Doctor Honoris Causa, Technical University of Budapest, Hungary, 1989

Doctor Honoris Causa, Medical University of Debrecen, Hungary, 1990

University of Florida Research Achievement Award, 1991

Leo Friend Award, American Chemical Society, 1996

Professorial Excellence Program Award, Univ. of FL, 1996

Volwiler Research Achievement Award, AACP, 1997

Gold Cross of Merit of the Hungarian Republic, awarded by Ferenc Madl, President of Hungary, on March 31, 2004

Other:

Visiting Professor, Assiut University, Assiut, Egypt, 1984

Visiting Professor, Hoshi University, Tokyo, Japan, 1995

Principal Investigator of numerous National Institutes of Health research grant awards

Member, Board of Trustees, ARKAT-USA

Chairman, Policy Committee of the Florida Center for Heterocyclic Compounds

Consultant, advisor, or Board of Directors member for numerous major pharmaceutical companies (Schering-Plough, ALCHEM Laboratories,ONO Pharmaceutical Co., Otsuka Pharmaceutical Co., Xenon Vision, Inc., Helene Curtis, Inc., etc.)

Invited speaker of over 400 international and national symposia and special lectures

Editorial Boards:

AAPS Journal Burger’s Medicinal Chemistry, 6th Edition Drug Design & Discovery Pharmaceutical Research Advanced Drug Delivery Reviews Pharmaceutical Science Communications Magyar Kemiai Folyoirat Journal of Ocular Pharmacology and Therapeutics Current Medicinal Chemistry Pharmacy and Pharmacology Communications Current Drugs Journal of Pharmacy and Pharmacology STP Pharma Sciences American Journal of Drug Delivery Expert Opinion on Drug Delivery

Languages: Speak: English, Hungarian, and Romanian Read and Write: French, Russian, and German

Publications: 500+

Patents: 180+

Memberships: American Chemical Society American Pharmaceutical Association Academy of Pharmaceutical Sciences American Association of Colleges of Pharmacy American Association of Pharmaceutical Scientists American Association for the Advancement of Science American Epilepsy Society Association for Ocular Pharmacology and Therapeutics New York Academy of Sciences International Union of Pure and Applied Chemistry Sigma Xi Controlled Release Society American College of Clinical Pharmacology International Scientific Advisory Panel of Oxford Molecular Group, PLC Worldwide Hungarian Medical Academy Hungarian National Academy of Sciences International Council of Scientific Unions

Graduate and Postdoctoral Supervised more than 50 doctoral students and 100 postdoctoral Supervision: research associates/fellows

PUBLICATIONS

1. N. Bodor, L. Fey, M. Kircz and F. Hodosan, "On Direct Iodination of the 20-Oxopregnanes," Rev. Roumaine Chim., 9, 147 (1964) (in English).

2. N. Bodor, "Isonitrosation of the Substituted Nitroalkylbenzenes. Application of the Hammet-Taft Equation," Chemistry Thesis, Babes-Bolyai University, Cluj, Romania (1965).

3. N. Bodor and A. Kovendi, "Structure and Reactivity in the Substituted Nitrobenzene Series. I. Kinetics and Mechanism of the Isonitrosation of Nitroalkylbenzenes in Alkaline Solution," Rev. Roumaine Chim., 11, 393 (1966) (in English).

4. N. Bodor, L. Fey and A. Kovendi, "Structure and Reactivity in the Substituted Nitrobenzene Series. II. The Effects of the Structure of Aliphatic Side-Chain on the Isonitrosation of the Nitroalkylbenzenes and on the Properties of the Corresponding Oximes Resulted from This Reaction," Rev. Roumaine Chim., 11, 405 (1966) (in English).

5. N. Bodor and A. Kovendi, "Structure and Reactivity in the Substituted Nitrobenzene Series. III. The Effect of p-Substituents on the Isonitrosation of the o-Nitroethylbenzene," Rev. Roumaine Chim., 11, 413 (1966) (in English).

6. N. Bodor, L. Fey and A. Kovendi, "Structure and Reactivity in the Substituted Nitrobenzene Series. IV. The Effect of p-Substituents on the Dissociation and Polarographic Reduction of the o-Nitroacetophenonoxime," Rev. Roumaine Chim., 11, 421 (1966) (in English).

7. N. Bodor, "Remote Effects in the Steroid Reactions," Rev. Chimie (Bucharest), 19(9), (1968) (in Romanian).

8. N. Bodor, "Remote Effects. I. On the Nature of the Effects of Remote Substituents," Rev. Roumaine Chim., 13, 555 (1968) (in English).

9. N. Bodor and O. Mantsch, "Remote Effects. II. Substituent Effects in Epoxidation of the Sterodic C-4,5 Double Bond " Rev. Roumaine Chim., 13, 1153 (1968) (in English).

10. N. Bodor, L. Fey and A. Kovendi, "Structure and Reactivity in the Substituted Nitrobenzene Series. V. The Effects of o-Substituents on the Dissociation and Polarographic Reduction of the p-Nitroacetophenonoxime," Rev. Chimie (Bucharest), 19, 552 (1968) (in Romanian). 11. O. Mantsch, N. Bodor and F. Hodosan, "Kinetische Untersuchungen am System Essigsaurehydrid-Salpetersaure-Essigsaure-Acetylnitrat," Rev. Roumaine Chim., 13, 1435 (1968) (in German).

12. N. Bodor and M. Dewar, "Ground States of Alpha-Bonded Molecules. VIII: MINDO Calculation for Species Involved in Nitration by Acetylnitrate," Tetrahedron, 25, 5777-5784 (1969).

13. L. Fey and N. Bodor, "Electronic Spectra of the Substituted α-Oximinoalkylbenzenes. I. Steric Effects on Electronic Absorption Spectra of the Substituted o-Nitro-α- Oximinoalkylbenzenes," Rev. Roumaine Chim., 14, 225 (1969) (in English).

14. L. Fey and N. Bodor, "Electronic Spectra of the Substituted Alpha-Oximinoalkylbenzenes. II. MO-Calculations of the Bathochromic Shifts Produced by the Dissociation of Benzaldoxime and p-Nitrobenzaldoxime," Rev. Roumaine Chim., 14, 319 (1969) (in English).

15. L. Fey and N. Bodor, "Electronic Spectra of the Substituted α-Oximinoalkylbenzenes. III. Steric Effects on Electronic Spectra of the o-Substituted p-Nitro-α-Oximinoalkylbenzenes," Rev. Roumaine Chim., 14, 481 (1969) (in English).

16. O. Mantsch and N. Bodor, "Kinetik und Mechanismus der Veresterungsreaktion von Steroidalkoholen mit Acetylnitrat," Rev. Roumaine Chim., 14, 1295 (1969) (in German).

17. N. Bodor, M. Dewar and A. Harget, "Ground States of Conjugated Molecules. XIX. Tautomerism of Heteroaromatic Hydroxy and Amino Derivatives and Nucleotide Bases," J. Amer. Chem. Soc., 92, 2929 (1970).

18. N. Bodor, M. Dewar, A. Harget and E. Haselbach, "Ground States of Alpha-Bonded Molecules. X. Extension of the MINDO/2 Method to Compounds Containing Nitrogen and/or Oxygen," J. Amer. Chem. Soc., 92, 3854-3859 (1970).

19. N. Bodor and M. Dewar, "Ground States of α-Bonded Molecules. XI. Conformation Analyses by MINDO/2 Method," J. Amer. Chem. Soc., 92, 4270-4274 (1970).

20. N. Bodor, M. Dewar and S. Worley, "Photoelectron Spectra of Molecules. III. Ionization Potentials of Some Cyclic Hydrocarbons and Their Derivatives, and Heats of Formation and Ionization Potentials Calculated by the MINDO SCF Method," J. Amer. Chem. Soc., 92, 19- 24 (1970).

21. N. Bodor, M. Dewar, W. Jennings and S. Worley, "Photoelectron Spectra of Molecules. IV. Ionization Potentials and Heats of Formation of Some Hydrazines and Amines," Tetrahedron, 26, 4109-4113 (1970).

22. N. Bodor and N. Trinajstic, "Valence-Shell MO-Calculations for Formamide and Related Compounds," Rev. Roumaine Chim., 15, 1807 (1970) (in English).

23. N. Bodor and M. Dewar, "Protonation of Cyclopropane" J. Amer. Chem. Soc., 93, 6685- 6686 (1971).

24. N. Bodor, M. Farkas and N. Trinajstic, "SCF MO Calculations for 1,3-Thiazole and 2- Phenyl-1, 3-Thiazole and Rotational Barriers in 2-Phenyl-1, 3-Thiazole and Its Protonated Form," Croat. Chem. Acta, 43, 107-111 (1971) (in English).

25. N. Bodor, E. Pop and N. Trinajstic, "Valence Shell and I-Electron SCF MO Calculations for the Isomerism of 21-Benzylidene 20-Oxopregnane Derivatives," Rev. Roumaine Chim., 16(9), 1427-1433 (1971) (in English).

26. N. Bodor, I. Schwartz and N. Trinajstic, "SCF MO Study of the Tautomerism of Anilino- thiazole and Related Compounds," Zeitschrift fur Naturforschung, 26b, 400-402 (1971) (in English).

27. N. Bodor, M. Dewar and D. Lo, "Ground States of Sigma-Bonded Molecules. XVIII. An Improved Version of MINDO/2 and Its Application to Carbonium Ions and Protonated Cyclopropanes," J. Amer. Chem. Soc., 94, 5303-5310 (1972).

28. N. Bodor, M. Dewar and J. Wasson, "Ground States of Molecules. XIX. Carbenes and Its Reactions," J. Amer. Chem. Soc., 94, 9095-9102 (1972).

29. N. Bodor and M. Dewar, "Ground States of Molecules. XX. MINDO/2 Study of Some Carbenes and Their Intramolecular Rearrangements," J. Amer. Chem. Soc., 94, 9103-9106 (1972).

30. N. Bodor, M. Dewar and Z. Maksic, "Ground States of Molecules. XXIV. MINDO/2 Study of Some Reactions of Cyclopropylidene," J. Amer. Chem. Soc., 95, 5245-5249 (1973).

31. N. Bodor, B. Chen and S. Worley, "Photoelectron Spectra and SCF MO Calculations for the Dimers of Cyclobutadiene," J. Elect. Spect. Rel. Phen., 4, 65-71 (1974).

32. N. Bodor, J. Kaminski, S. Worley, R. Colton, T. Lee and J. Rabalais, "Photoelectron Spectra, Hydrolytic Stability, and Antimicrobial Activity of N-Chlorinated Piperidines," J. Pharm. Sci., 63, 1387-1391 (1974).

33. N. Bodor, E. Shek and T. Higuchi, "Delivery of a Quaternary Pyridinium Salt Across the Blood-Brain Barrier by Its Dihydropyridine Derivative," Science, 190, 155-156 (1975).

34. A. Repta, B. Rawson, R. Shaffer, K. Sloan, N. Bodor and T. Higuchi, "Rational Development of a Soluble Prodrug of Cytotoxic Nucleoside: Preparation and Properties of Arabinosyladenine-5'-Formate," J. Pharm. Sci., 64, 392-396 (1975).

35. N. Bodor, M. Dewar and Z. Maksic, "A Study of the Interactions Between the Double Bonds in Unsaturated Ketones," Croat. Chem. Acta, 48, 9-15 (1976).

36. N. Bodor, E. Shek and T. Higuchi, "Improved Delivery Through Biological Membranes. I. Synthesis and Properties of 1-Methyl-1,6-dihydropyridine-2-carbaldoxime, a Prodrug of N- Methylpyridinium-2-carbaldoxime Chloride," J. Med. Chem., 19, 102-107 (1976).

37. J. Kaminski and N. Bodor, "3-Bromo-4, 4-Dimethyl-2-oxazolidinone: Preparation and Investigation of a New Brominating Agent," Tetrahedron, 32, 1097-1099 (1976).

38. J. Kaminski, N. Bodor and T. Higuchi, "N-Halo Derivatives III: Stabilization of Nitrogen Chlorine Bond in N-Chloroamino Acid Derivatives," J. Pharm. Sci., 65, 553-557 (1976).

39. J. Kaminski, N. Bodor and T. Higuchi, "N-Halo Derivatives IV: Synthesis of Low Chlorine Potential Soft N-Chloramine Systems," J. Pharm. Sci., 65, 1733-1737 (1976).

40. J. Kaminski, M. Huycke, S. Selk, N. Bodor and T. Higuchi, "N-Halo Derivatives V: Comparative Antimicrobial Activity of Soft N-Chloramine Systems," J. Pharm. Sci., 65, 1737-1742 (1976).

41. M. Kosugi, J. Kaminski, S. Selk, I. Pitman, N. Bodor and T. Higuchi, "N-Halo Derivatives VI: Microbiological and Chemical Evaluations of 3-Chloro-2-oxazolidinones," J. Pharm. Sci., 65, 1743-1746 (1976).

42. E. Shek, T. Higuchi and N. Bodor, "Improved Delivery Through Biological Membranes. 2. Distribution, Excretion, and Metabolism of N-Methyl-1, 6-dihydropyridine-2-carbaldoxime Hydrochloride, a Pro-Drug of N-Methylpyridinium-2carbaldoxime Chloride," J. Med. Chem., 19, 108-112, (1976).

43. E. Shek, T. Higuchi and N. Bodor, "Improved Delivery Through Biological Membranes. 3. Delivery of N-Methylpyridinium-2-carbaldoxime Chloride through the Blood-Brain Barrier in Its Dihydropyridine Pro-Drug Form," J. Med. Chem., 19, 113-117 (1976).

44. K. Sloan and N. Bodor, "O-Acylation of Acidic Methylene Compounds," J. Org. Chem., 41, 165-166 (1976).

45. S. Yuan and N. Bodor, "Synthesis and Activity of (R)-(-)-m-Trimethylacetoxy- α[(methylamino)methyl]benzyl Alcohol Hydrochloride: A Prodrug Form of (R)-(-)- Phenylephrine," J. Pharm. Sci., 65, 929-931 (1976).

46. N. Bodor, "Novel Approaches for the Design of Membrane Transport Properties of Drugs," Chapter 7 in Design of Bio-Pharmaceutical Properties Through Pro-Drugs and Analogs, E. B. Roche, Ed., Symposium Proceedings of Academy of Pharm. Sci., 98-135 (1977).

47. N. Bodor, K. Sloan, T. Higuchi and K. Sasahara, "Improved Delivery Through Biological Membranes. 4. Prodrugs of L-Dopa," J. Med. Chem., 20, 1435-1445, (1977).

48. J. Kaminski, S. Worley and N. Bodor, "N-Halo Derivatives. VII. Mass Spectra of a Series of 3-Halo-2-Oxazolidinones," Org. Mass Spectrom., 12, 145-149 (1977).

49. K. Sloan, N. Bodor, T. Higuchi, R. Little and M. Wu, "Micellar Acceleration of Phosphorylation of Hydroxamic Acids: Effect of Chain Length and of an Intramolecular Tertiary Amino-group," J. Chem. Res.(S), 290-291 (1977).

50. N. Bodor, J. Kaminski and R. Roller, "Improved Delivery Through Biological Membranes. VI. Potent Sympathomimetic Adrenalone Derivatives," Int. J. Pharm., 1, 189-196 (1978).

51. N. Bodor and R. Pearlman, "Formation, Stability and Protonation of Dihydropyridines. A MINDO/3 Study," J. Am. Chem. Soc., 100, 4946-4953 (1978).

52. N. Bodor, R. Roller and S. Selk, "Elimination of a Quaternary Pyridinium Salt Delivered as Its Dihydropyridine Derivative from Brain of Mice," J. Pharm. Sci., 67, 685-687 (1978).

53. N. Bodor, K. Sloan, N. Kuo and T. Higuchi, "Controlled Delivery of Theophylline: Chemistry of 7-Acyl- and 7,7' Acylditheophylline Derivatives," J. Pharm. Sci., 67, 1045- 1050 (1978).

54. J. Epstein, J. Kaminski, N. Bodor, R. Enever, J. Sowa and T. Higuchi, "Micellar Acceleration of Organophosphate Hydrolysis by Hydroximinomethylpyridinium Type Surfactants," J. Org. Chem., 43, 2816-2821 (1978).

55. S. Gerson, S. Worley, N. Bodor, J. Kaminski and T. Flechtner, "The Photoelectron Spectra of some Heterocyclic Compounds which contain N, O, C1 and Br," J. Electr. Spectr. Rel. Phen., 13, 421-434 (1978).

56. S. Gerson, S. Worley, N. Bodor and J. Kaminski, "Electronic Structures of Some Antimicrobial N-Chloramines. Possible Existence of Intramolecular Hydrogen Bonding and Its Effect on Germicidal Efficiency," J. Med. Chem., 21, 686-688 (1978).

57. J. Kaminski, K. Knutson and N. Bodor, "A Convenient Method of Anion Exchange in Quaternary Salts," Tetrahedron, 34, 2857-2859 (1978).

58. K. Sloan, R. Little and N. Bodor, "Acid-Catalyzed Rearrangements of the Dihydroxyacetone Side Chain in Steroids during Ketal Exchange," J. Org. Chem., 43, 3405-3408 (1978).

59. S. Worley, S. Gerson, N. Bodor and J. Kaminski, "The Electronic Structures of Some Biological Piperazines," Chem. Phys. Letters, 60, 104-107 (1978).

60. S. Worley, S. Gerson, N. Bodor, J. Kaminski and T. Flechtner, "On the Structure of N- Chlorosuccinimide and N-Bromosuccinimide. A Photoelectron Spectroscopic Study," J. Chem. Phys., 68, 1313-1315 (1978).

61. J. Kaminski and N. Bodor, "Determination of Penicillins and Cephalosporins Using 3- Bromo-4, 4-dimethyl-2-oxazolidinone," Int. J. Pharm., 3, 151-156 (1979).

62. R. Pearlman and N. Bodor, "Configurational Analysis, Inversion and Reduction of Some Pyridine Carbaldoximes," ACS Symposium Series, No. 112., Computer-Assisted Drug Design, E. Olson and R. Christoffersen, Eds., Washington D.C., p. 489-506 (1979).

63. N. Bodor, J. Kaminski and S. Selk, "Soft Drugs 1. Labile Quaternary Ammonium Salts as Soft Antimicrobials," J. Med. Chem., 23, 469-474 (1980).

64. N. Bodor and J. Kaminski, "Soft Drugs 2. Soft Alkylating Compounds as Potential Antitumor Agents," J. Med. Chem., 23, 566-569 (1980).

65. N. Bodor, J. Kaminski, S. Worley and S. Gerson, "Quantitative Evaluation of the Reactivity of Alkylating Agents," Z. Naturforsch, 35b, 758-763 (1980).

66. N. Bodor, K. Knutson and T. Sato, "Resolution of Chiral Phosphamides," J. Am. Chem. Soc., 102, 3969-3971 (1980).

67. N. Bodor, R. Woods, C. Raper, P. Kearney and J. Kaminski, "Soft Drugs 3. A New Class of Anticholinergic Agents," J. Med. Chem., 23, 474-480 (1980).

68. N. Bodor, J. Zupan and S. Selk, "Improved Delivery Through Biological Membranes VII. Dermal Delivery of Cromoglycic Acid (Cromolyn) Via its Prodrugs," Int. J. Pharm., 7, 63- 75 (1980).

69. H. Kohl, W. Wheatley, S. Worley and N. Bodor, "Antimicrobial Activity of N-Chloramine Compounds," J. Pharm. Sci., 69, 1292-1295 (1980).

70. N. Bodor, "Novel Approaches in Prodrug Design," Drugs of the Future, 6(3), 165-182 (1981).

71. N. Bodor, H. Farag and M. Brewster, "Site-Specific, Sustained Release of Drugs to the Brain," Science, 214, 1370-1372 (1981).

72. H. Burkett, J. Faison, H. Kohl, W. Wheatley, S. Worley and N. Bodor, "A Novel Chloramine Compound for Water Disinfection," Water Res. Bul., 17, 874-879 (1981).

73. T. Loftsson, J. Kaminski and N. Bodor, "Improved Delivery Through Biological Membranes. VIII. Design, Synthesis and In Vivo Testing of True Prodrugs of Aspirin," J. Pharm, Sci., 70, 743-749 (1981).

74. T. Loftsson and N. Bodor, "Improved Delivery Through Biological Membranes. IX. Kinetics and Mechanism of Hydrolysis of Methylsulfinylmethyl-2-acetoxybenzoate and Related Aspirin Prodrugs," J. Pharm. Sci., 70, 750-755 (1981).

75. T. Loftsson and N. Bodor, "Improved Delivery Through Biological Membranes. X. Percutaneous Absorption and Metabolism of Methylsulfinylmethyl-2-Acetoxybenzoate and Related Aspirin Prodrugs," J. Pharm. Sci., 70, 756-758 (1981)

76. K. Sloan, N. Bodor and R. Little, "13C NMR Spectroscopy of 4,5-and 5,6-Double Bond Isomers of Spiro-3-Steroidal Ketone Derivatives: The Determination of the Structures of Steroidal Thiazolidines," Tetrahedron, 37, 3467-3471 (1981).

77. K. Sloan, N. Bodor and J. Zupan, "Acylation of the 4,5- and 5,6 Double Bond Isomers of 3- Steroidal Thiazolidines," Tetrahedron, 37, 3463-3466 (1981).

78. S. Worley, W. Wheatley, H. Kohl, H. Burkett, J. Faison, J. Van Hoose and N. Bodor, "A Novel Bactericidal Agent for Treatment of Water," Chapter 78 in Water Chlorination Environmental Impact and Health Effects, Vol. 4., R. Jolley, W. Brungs, J. Cotruvo, R. Cumming, J. Mattice and V. Jacobs, Eds., Proceedings of the Fourth Conference on Water Chlorination, 1105-1113 (1981).

79. N. Bodor, "Designing Safer Drugs Based on the Soft Drug Approach," Trends in Pharmacological Sciences, 3(2), 53-56 (1982).

80. N. Bodor, "Novel Approaches to Prodrug Design," Optimization of Drug Delivery, Alfred Benzon Symposium, 17, H. Bundgaard, A. B. Hansen and H. Kofod, Eds., Munksgaard, Copenhagen, 156-177, 1982.

81. N. Bodor, "Soft Drugs: Strategies for Design of Safer Drugs," in Strategy in Drug Research, Proceedings of the 2nd IUPAC-IUPHAR Symposium on Research, Noordwijkerhout, J. A. Keverling Buisman, Ed., Elsevier Scientific Publishing Company, Amsterdam, 137-164, 1982.

82. N. Bodor, K. Sloan, R. Little, S. Selk and L. Caldwell, "Soft Drugs 4. 3-Spirothiazolidines of Hydrocortisone and Its Derivatives," Int. J. Pharm., 10, 307-321 (1982).

83. N. Bodor and K. Sloan, "Soft Drugs V. Thiazolidine-Type Derivatives of Progesterone and Testosterone," J. Pharm. Sci., 71(5), 514-520 (1982).

84. T. Loftsson and N. Bodor, "Synthesis and Hydrolysis of Some Pivaloyloxymethyl and Pivaloyl Derivatives of Phenolic Compounds," Arch. Pharm. Chemi. Sci. Ed., 10, 104-110 (1982).

85. E. Mora, H. Kohl, W., Wheatley, S. Worley, J. Faison, H. Burkett and N. Bodor, "Properties of a New Chloramine Disinfectant and Detoxicant," Poultry Science, 61, 1968-1971 (1982).

86. K. Sloan and N. Bodor, "Hydroxymethyl and Acyloxymethyl Prodrugs of Theophylline: Enhanced Delivery of Polar Drugs Through Skin," Int. J. Pharm., 12, 299-313 (1982).

87. N. Bodor, "Soft Drugs: Strategies for Design of Safer Drugs," Metab. Concept. Med. Quo Vadis? [Symp.], 217-251 (1983).

88. N. Bodor and M. Brewster, "Problems of Delivery of Drugs to the Brain," Pharm. Ther., 19(3), 337-386 (1983).

89. N. Bodor and H. Farag, "Improved Delivery Through Biological Membranes 11. A Redox Chemical Drug-Delivery System and Its Use for Brain Specific Delivery of Phenylethylamine," J. Med. Chem., 26, 313-318 (1983).

90. N. Bodor and K. Sloan, "Improved Delivery Through Biological Membranes XII. The Effect of the Incorporation of Biphasic Solubilizing Groups Into Prodrugs of Steroids," Int. J. Pharm., 15, 235-250 (1983).

91. N. Bodor and H. Farag, "Improved Delivery Through Biological Membranes. 13. Brain Specific Delivery of Dopamine with a Dihydropyridine _ Pyridinium Salt Type Redox Delivery System," J. Med. Chem., 26, 528-534 (1983).

92. N. Bodor and M. Brewster, "Improved Delivery Through Biological Membranes XV. Sustained Brain Delivery of Berberine," Eur. J. Med. Chem., 18, 235-240 (1983).

93. N. Bodor, A. Harget and E. Phillips, "Structure-Activity Relationships in the Antiinflammatory Steroids: A Pattern Recognition Approach," J. Med. Chem., 26, 318-328 (1983).

94. N. Bodor, A. Harget and E. Phillips, "Structure-Activity Relationships in the Antiinflammatory Steroids: A Pattern Recognition Approach," Croat. Chem. Acta, 56(2), 175-183 (1983) (in English).

95. N. Bodor and J. Simpkins, "Redox Delivery System for Brain-Specific, Sustained Release of Dopamine, " Science, 221(4605), 65-67 (1983).

96. N. Bodor, K. Sloan, J. Kaminski, C. Shih and S. Pogany, "A Convenient Synthesis of (Acyloxy)alkyl α-Ethers of Phenols," J. Org. Chem., 48, 5280-5284 (1983).

97. M. Brewster and N. Bodor, "Improved Delivery Through Biological Membranes XVI. Enhancement of the Brain Specificity of a Dihydropyridine _ Pyridinium Salt Drug Delivery System by Controlled Infusion," J. Parenteral Sci. Tech., 37(5), 159-164 (1983).

98. T. Sato, H. Ueda, K. Nakagawa and N. Bodor, "Asymmetric Synthesis of Enantiomeric Cyclophosphamides," J. Org. Chem., 48, 98-101 (1983).

99. K. Sloan, M. Hashida, J. Alexander, N. Bodor and T. Higuchi, "Prodrugs of 6-Thiopurines: Enhanced Delivery Through the Skin," J. Pharm. Sci., 72(4), 372-378 (1983).

100. S. Worley, W. Wheatley, H. Kohl, H. Burkett, J. Faison, J. Van Hoose and N. Bodor, Water Chlorination: Environmental Impact and Health Effects, 4, 372-378 (1983).

101. S. Worley, W. Wheatley, H. Kohl, H. Burkett, J. Van Hoose and N. Bodor, "A New Water Disinfectant: A Comparative Study," Ind. Eng. Chem. Prod. Res. Dev., 22, 716-718 (1983).

102. S. Worley, W. Wheatley, H. Kohl, J. Van Hoose, H. Burkett and N. Bodor, "The Stability in Water of a New Chloramine Disinfectant," Water Res. Bul., 19, 97-100 (1983).

103. N. Bodor, "Novel Approaches to the Design of Safer Drugs: Soft Drugs and Site-Specific Chemical Delivery Systems," chapter in Advances in Drug Research, 13, 255-331, Academic Press, London, 1984.

104. N. Bodor, "The Soft Drug Approach," Chemtech, January, 28-38 (1984).

105. N. Bodor, "Soft Drugs: Principles and Methods for the Design of Safe Drugs," Med. Res. Reviews, 3(4), 449-469 (1984).

106. N. Bodor and H. Farag, "Improved Delivery Through Biological Membranes XIV. Brain Specific, Sustained Delivery of Testosterone Using a Redox Chemical Delivery System," J. Pharm. Sci., 73(3), 385-389 (March 1984).

107. N. Bodor, Y. Oshiro, T. Loftsson, M. Katovich and W. Caldwell, "Soft Drugs VI. The Application of the Inactive Metabolite Approach for Design of Soft β-Blockers, Pharm. Res., 3, 120-125, May (1984).

108. N. Bodor and G. Visor, "Formation of Adrenaline in the Iris-Ciliary Body from Adrenalone Diesters," Exp. Eye Res., 38, 621-626 (1984).

109. N. Bodor and G. Visor, "Improved Delivery Through Biological Membranes. XVII. A Site- Specific Chemical Delivery System as a Short-Acting Mydriatic Agent," Pharm. Res., 4, 168-173 (1984).

110. M. Katovich, J. Simpkins, I. Song, N. Bodor and R. Tuttle, "A Rapid Quantitative In Vivo Assay for Narcotic Antagonists," Substance and Alcohol Actions/Misuse, 5, 87-95 (1984).

111. T. Loftsson, M. Matsuo, R. Caldwell, N. Gildersleeve and N. Bodor, "Synthesis and Evaluation of Novel Lidocaine Sulfur Analogs," Int. J. Pharm., 22, 345-355 (1984).

112. N. Bodor, "Novel Approaches to the Design of Safer Drugs by Site-Specific Chemical Delivery Systems," chapter in Advances in Drug Delivery Systems, H. P. Tipnis, Ed., MSR Foundation, Bombay, India, 111-127 (1985).

113. N. Bodor, "Prodrugs Vs. Soft Drugs," chapter in Design of Prodrugs, H. Bundgaard, Ed., Elsevier Science Publishers B. V., Amsterdam, The Netherlands, 333-354, 1985.

114. N. Bodor, "Targeting of Drugs to the Brain," Chapter in Methods in Enzymology, Drug & Enzyme Targeting, Part A, K. J. Widder, Ed., Academic Press, 112, 381-396, 1985.

115. N. Bodor and M. Abdelalim, "Improved Delivery Through Biological Membranes XIX: Novel Redox Carriers for Brain-Specific Chemical Delivery Systems," J. Pharm. Sci., 74(3), 241-245 (1985).

116. B. Michniak-Mikolzjczak and N. Bodor, "A Study of the Penetration of Five Novel Synthetic Steroids Through Hairless Mouse Skin In Vitro, Int. J. Cosmetic Sci., 7, 175-179 (1985).

117. J. Simpkins, N. Bodor and A. Enz, "Direct Evidence for Brain Specific Release of Dopamine from a Redox Delivery System," J. Pharm. Sci., 74(10), 1033-1036 (1985).

118. N. Bodor and M. Abdelalim, "Improved Delivery Through Biological Membranes XX. Nicotinamide _ Dihydronicotinamide Based Ester-linked Redox Carrier Systems," J. Pharm. Sci., 75(1), 29-35 (1986).

119. N. Bodor and M. Brewster, "A MINDO/3 Study of a Substituted Benzo(b)-isoquinolizinium Salt _ Benzo(b)quinolizine System," J. Mol. Struct. (THEOCHEM), 138, 261-270 (1986).

120. N. Bodor and M. Brewster, "Problems of Delivery of Drugs to the Brain," chapter in Methods of Drug Delivery, Int. Enc. of Pharm. & Ther., Section 120, G. M. Ihler, Ed., Pergamon Press, New York, 153-202 (1986).

121. N. Bodor, M. El-Kommos and C. Nath, "In Vivo Elimination of Dihydropyridine Drug Delivery Carriers from Brain and Blood of Rats," Bulletin of Pharmaceutical Sciences, Assiut University, 9(2), 14-29 (1986).

122. N. Bodor, T. Nakamura and M. Brewster, "Improved Delivery Through Biological Membranes XXIII. Synthesis, Distribution and Neurochemical Effects of a Tryptamine Chemical Delivery System," Drug Des. & Del., 1, 51-64 (1986).

123. M. Brewster, K. Estes and N. Bodor, "Improved Delivery Through Biological Membranes XXIV. Synthesis, In Vitro Studies, and In Vivo Characterization of Brain-Specific and Sustained Progestin Delivery Systems," Pharm. Res., 3, 278-285 (1986).

124. K. Rand, N. Bodor, A. El-Koussi, I. Raad, A. Miyake, H. Houck and N. Gildersleeve, "Potential Treatment of Herpes Simplex Virus Encephalitis by Brain-Specific Delivery of Trifluorothymidine Using a Dihydropyridine _ Pyridinium Salt Type Redox Delivery System," J. Med. Virol., 20, 1-8 (1986).

125. J. Simpkins, J. McCornack, K. Estes, M. Brewster, E. Shek and N. Bodor, "Sustained Brain- Specific Delivery of Estradiol Causes Long-Term Suppression of Luteinizing Hormone Secretion," J. Med. Chem., 29, 1809-1812 (1986).

126. N. Bodor, "Chemical Drug Delivery Systems," Chapter in Theory and Application of Bioreversible Carriers Drug Design, E. B. Roche, Ed., Symposium Proceedings of Academy of Pharm. Sci., Pergamon Press, New York, 95-120 (1987).

127. N. Bodor, "Novel Site-Specific Chemical Drug Delivery Systems," chapter in Trends in Medicinal Chemistry, Proceedings of the IXth International Symposium on Medicinal Chemistry," E. Mutschler and E. Winterfeldt, Eds., VCH Verlagsgesellschaft, West Germany, 195-210 (1987).

128. N. Bodor, "Redox Drug Delivery Systems for Targeting Drugs to the Brain," Biological Approaches to the Controlled Delivery of Drugs, Ann. N. Y. Acad. Sci., 507, 289-306 (1987).

129. N. Bodor and J. Kaminski, "Prodrugs and Site-Specific Chemical Delivery Systems," Chapter 30 in Ann. Reports in Med. Chem., 22, D. Bailey, Ed., Academic Press, 303-313 (1987).

130. N. Bodor and T. Loftsson, "Novel Chemical Approaches for Sustained Drug Delivery," Chapter in Controlled Drug Delivery, J. R. Robinson and V. H. L. Lee, Eds., Marcel Dekker, 337-371 (1987).

131. N. Bodor, J. McCornack and M. Brewster, "Improved Delivery Through Biological Membranes XXII. Synthesis and Distribution of Brain-Selective Estrogen Delivery Systems," Int. J. Pharm., 35, 47-59 (1987).

132. W. Anderson, J. Simpkins, M. Brewster and N. Bodor, "Evidence for the Reestablishment of Copulatory Behavior in Castrated Male Rats with a Brain-Enhanced Estradiol-Chemical Delivery System," Pharmacol. Biochem. & Behav., 27, 265-271 (1987).

133. W. Anderson, J. Simpkins, M. Brewster and N. Bodor, "Evidence for Suppression of Serum LH Without Elevation in Serum Estradiol or Prolactin with a Brain-Enhanced Redox Delivery System for Estradiol," Life Sci., 42(16), 1493-1502 (1987).

134. W. Anderson, J. Simpkins, P. Woodard, D. Winwood, W. Stern and N. Bodor, "Anxiolytic Activity of a Brain Delivery System for GABA," Psychopharmacol., 92(2), 157-163 (1987).

135. M. Brewster, V. Venkatraghavan, E. Shek and N. Bodor, "Facile, One-Step Preparation of Trigonellinate Esters," Synth. Commun., 17(4), 451-455 (1987).

136. A. El-Koussi and N. Bodor, "Improved Delivery Through Biological Membranes XXV. Enhanced and Sustained Delivery of Trifluorothymidine to the Brain Using a Dihydropyridine _ Pyridinium Salt Type Redox Delivery System," Drug Des. & Del., 1, 275-283 (1987).

137. K. Estes, M. Brewster and N. Bodor, "Use of a Chemical Redox System for Brain-Enhanced Delivery of Estradiol Decreases Prostate Weight," Biological Approaches to the Controlled Delivery of Drugs, Ann. N. Y. Acad. Sci., 507, 334-336 (1987).

138. K. Estes, M. Brewster, J. Simpkins and N. Bodor, "A Novel Redox System for CNS- Directed Delivery of Estradiol Causes Sustained LH Suppression in Castrate Rats," Life Sci., 40, 1327-1334 (1987).

139. T. Loftsson, N. Gildersleeve and N. Bodor, "The Effect of Vehicle Additives on the Transdermal Delivery of Nitroglycerin," Pharm. Res., 4(5), 436-437 (1987).

140. K. Raghavan, E. Shek and N. Bodor, "Improved Delivery Through Biological Membranes XXX. Synthesis and Biological Aspects of a 1,4-Dihydropyridine Based Chemical Delivery System for Brain-Sustained Delivery of Hydroxy CCNU," Anti-Cancer Drug Des., 2, 25-36 (1987).

141. K. Rand, I. Raad, A. El-Koussi, H. Houck, W. Brey, J. Rocca, T. Loftsson and N. Bodor, "Trifluorothymidine: Potential Non-Invasive Diagnosis of Herpes Simplex Infection Using 19F Nuclear Magnetic Resonance in a Murine Hepatitis Model," J. Virol. Methods, 18, 257- 270 (1987).

142. P. Stacpoole, M. Gonzalez, J. Vlasak, Y. Oshiro and N. Bodor,2 "Dichloroacetate Derivatives: Metabolic Effects and Pharmacodynamics in Normal Rats," Life Sci., 41, 2167- 2176 (1987).

143. N. Bodor, "The Application of Soft Drug Approaches to the Design of Safer Corticosteroids," Chapter in Topical Corticosteroid Therapy: A Novel Approach to Safer Drugs, E. Christophers et al., Eds., Raven Press, Ltd., New York, 13-25 (1988).

144. N. Bodor, M. Brewster and J. Kaminski, "Theoretical Studies on the Hydride Transfer Between 1-Methyl-1,4-Dihydronicotinamide and Its Corresponding Pyridinium Salt," Tetrahedron, 44(24), 7601-7610 (1988).

145. N. Bodor and A. El-Koussi, "Novel 'Soft' β-Blockers as Potential Safe Antiglaucoma Agents," (Part 8 in Soft Drug Series), Cur. Eye Res., 7(4), 369-374 (1988).

146. N. Bodor, A. El-Koussi, M. Kano, and M. Khalifa, "Soft Drugs 7. β-Blockers for Systemic and Ophthalmic Use," J. Med. Chem., 31, 1651-1656 (1988).

147. N. Bodor, A. El-Koussi, M. Kano and T. Nakamura, "Improved Delivery Through Biological Membranes 26. Design, Synthesis, and Pharmacological Activity of a Novel Chemical Delivery System for β-Adrenergic Blocking Agents," J. Med. Chem., 31, 100-106 (1988).

148. N. Bodor and J. Kaminski, "Reactivity of Biologically Important Reduced Pyridines I. Correlation Between Hydride Transfer and One-Electron Oxidation of Dihydropyridines and Heterocycles," J. Mol. Struct. (THEOCHEM), 163, 315-330 (1988).

149. W. Anderson, J. Simpkins, M. Brewster and N. Bodor, "Brain-Enhanced Delivery of Testosterone Using a Chemical Delivery System Complexed with 2-Hydroxypropyl-β- Cyclodextrin," Drug Des. & Del., 2(4), 287-298 (1988).

150. W. Anderson, J. Simpkins, M. Brewster and N. Bodor, "Effects of a Brain-Enhanced Chemical Delivery System for Estradiol on Body Weight and Serum Hormones in Middle- Aged Male Rats," Endo. Res., 14(2&3), 131-148 (1988).

151. M. Brewster, K. Estes and N. Bodor, "Improved Delivery Through Biological Membranes. XXXII. Synthesis and Biological Activity of Brain-Targeted Delivery Systems for Various Estradiol Derivatives," J. Med. Chem., 31, 244-249 (1988).

152. M. Brewster, K. Estes and N. Bodor, "Use of a Chemical Redox System for Delivery of Drugs to the Brain: Ethinyl Estradiol," Ann. N. Y. Acad. Sci., 529, 298-300 (1988).

153. M. Brewster, K. Estes, T. Loftsson, R. Perchalski, H. Derendorf, G. Mullersman and N. Bodor, "Improved Delivery Through Biological Membranes XXXI. Solubilization and Stabilization of an Estradiol Chemical Delivery System by Modified β-Cyclodextrins," J. Pharm. Sci., 77, 981-985 (1988).

154. M. Brewster, K. Estes, R. Perchalski and N. Bodor, "A Dihydropyridine Conjugate Which Generates High and Sustained Levels of the Corresponding Pyridinium Salt in the Brain Does Not Exhibit Neurotoxicity in Cynomolgus Monkeys," Neurosci. Letters, 87, 277-282 (1988).

155. M. Brewster, J. Kaminski and N. Bodor, "Reactivity of Biologically Important Reduced Pyridines. 2. The Oxidation of 1-Methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP). An MNDO Study," J. Am. Chem. Soc., 110(19), 6337-6341 (1988).

156. M. Brewster, T. Loftsson, K. Estes, G. Mullersman, H. Derendorf and N. Bodor, "Water Soluble Complexes of a Brain-Targeted Drug Delivery System," Proceeding of the Fourth International Symposium on Cyclodextrins, O. Huber and J. Szejtli, Eds., Kluwer Academic Publishers, Dordrecht, 399-405 (1988).

157. K. Estes, M. Brewster and N. Bodor, "A Redox System for Brain Targeted Estrogen Delivery Causes Chronic Body Weight Decrease in Rats," Life Sci., 42, 1077-1084 (1988).

158. R. Hammer, K. Amin, Z. Gunes, G. Brouillette and N. Bodor, "Novel Soft Anticholinergic Agents," Drug Des. & Del., 2, 207-219 (1988).

159. G. Mullersman, H. Derendorf, M. Brewster, K. Estes and N. Bodor, "High Performance Liquid Chromatographic Assay of a Central Nervous System-Directed Estradiol Chemical Delivery System and Its Application after Intravenous Administration to Rats," Pharm. Res., 5, 172-177 (1988).

160. J. Simpkins, W. Anderson, R. Dawson, Jr., A. Seth, M. Brewster, K. Estes and N. Bodor, "Chronic Weight Loss in Lean and Obese Rats with a Brain-Enhanced Chemical Delivery System for Estradiol," Physiol. & Behav., 44(5), 573-580 (1988).

161. N. Bodor, "Designing Safer Ophthalmic Drugs," chapter in Proceedings of the Xth International Symposium on Medicinal Chemistry, Trends in Med. Chem. '88, H. van der Goot, G. Domany, L. Pallos and H. Timmerman, Eds., Elsevier Science Publishers, B.V., Amsterdam, 145-164 (1989).

162. N. Bodor, Z. Gabanyi and C. Wong, "A New Method for the Estimation of Partition Coefficient," J. Am. Chem. Soc., 111, 3783-3786 (1989).

163. N. Bodor, V. Venkatraghavan, D. Winwood, K. Estes and M. Brewster, "Improved Delivery Through Biological Membranes. XLI. Brain-Enhanced Delivery of Chlorambucil," Int. J. Pharm., 53, 195-208 (1989).

164. W. Anderson, J. Simpkins, M. Brewster and N. Bodor, "Evidence for Prolonged Suppression of Stress-Induced Release of Adrenocorticotropic Hormone and Corticosterone with a Brain- Enhanced Dexamethasone Redox Delivery System," Neuroendocrinol., 50(1), 9-16 (1989).

165. M. Brewster, K. Estes and N. Bodor, "Development of a Non-Surfactant Formulation for Alfaxalone Through the Use of Chemically-Modified Cyclodextrins," J. Parenteral Sci. & Tech., 43(6), 262-265 (1989).

166. M. Brewster, J. Kaminski, Z. Gabanyi, K. Czako, Agnes Simay and N. Bodor, "Reactivity of Biologically Important Reduced Pyridines V. Relative Importance of Electron Versus Proton Loss in Ferricyanide-Mediated Oxidation of Dihydronicotinamides," Tetrahedron, 45(14), 4395-4402 (1989).

167. M. Brewster, C. Robledo-Luiggi, A. Miyake, E. Pop and N. Bodor, "Improved Delivery Through Biological Membranes 44. Brain-Enhanced Delivery of Anti-Dementia Drugs," Chapter in Neurobiology of Aging, E. Meyers, Ed., Plenum, New York, 173-183 (1989).

168. M. Brewster, Agnes Simay, K. Czako, D. Winwood, H. Farag and N. Bodor, "Reactivity of Biologically Important Reduced Pyridines. 4. Effect of Substitution on Ferricyanide- Mediated Oxidation Rates of Various 1,4-Dihydropyridines," J. Org. Chem., 54, 3721-3726 (1989).

169. M. Brewster, J. Simpkins, M. Hora, W. Stern and N. Bodor, "The Potential Use of Cyclodextrins in Parenteral Formulations," J. Parenteral Sci. Tech., 43(5), 231-240 (1989).

170. A. El-Koussi and N. Bodor, "Formation of Propranolol in the Iris-Ciliary Body from Its Propranolol Ketoxime Precursor - A Potential Antiglaucoma Drug," Int. J. Pharm., 53, 189- 194 (1989).

171. A. Katritzky, G. Savage, M. Pilarska, N. Bodor and M. Brewster, "The Response to Vapor Challenges of New Microsensor Coatings: Nicotinic Acid Derivatives," Chemica Scripta, 29, 319-323 (1989).

172. T. Loftsson, S. Bjornsdottir, G. Palsdottir and N. Bodor, "The Effects of 2-Hydroxypropyl-β- Cyclodextrin on the Solubility and Stability of Chlorambucil and Melphalan in Aqueous Solution," Int. J. Pharm., 54, 63-72 (1989).

173. T. Loftsson and N. Bodor, "Effects of 2-Hydroxypropyl-β-Cyclodextrin on the Aqueous Solubility of Drugs and Transdermal Delivery of 17-β-Estradiol," Acta Pharm. Nordica, 1(4), 185-194 (1989).

174. T. Loftsson, N. Gildersleeve, R. Soliman and N. Bodor, "Effect of Oleic Acid on Diffusion of Drugs Through Hairless Mouse Skin," Acta Pharm. Nordica, 1(1), 17-22 (1989).

175. T. Loftsson, G. Somogyi and N. Bodor, "Effect of Choline Esters and Oleic Acid on the Penetration of Acyclovir, Estradiol, Hydrocortisone, Nitroglycerin, Retinoic Acid and Trifluorothymidine Across Hairless Mouse Skin in Vitro," Acta Pharm. Nordica, 1(5), 279- 286 (1989).

176. T. Murakami, E. Shek, E. Pop and N. Bodor, "Improved Anticonvulsant Activity of Phenytoin by a Redox Brain Delivery System: Stability in Buffers and Biological Materials," (XXVIII in Improved Delivery Series), J. Pharm. Sci., 78(9), 732-737 (1989).

177. M. Phelan and N. Bodor, "Improved Delivery Through Biological Membranes XXXVII. Synthesis and Stability of Novel Redox Derivatives of Naproxen and Indomethacin," Pharm. Res., 6(8), 667-676 (1989).

178. E. Pop, M. Brewster, J. Kaminski and N. Bodor, "Theoretical Aspects of Cephalosporin Isomerism," Int. J. Quan. Chem., Quantum Biol. Symposium, 16, 291-300 (1989).

179. E. Pop, M. Brewster, J. Kaminski and N. Bodor, "Theoretical Study of Some Heterocyclic Amines with Applications to the Chemistry of 9-Amino-1,2,3,4-tetrahydroacridine, Int. J. Quantum Chem., 35, 315-324 (1989).

180. E. Pop, E. Shek, T. Murakami and N. Bodor, "Improved Anticonvulsant Activity of Phenytoin by a Redox Brain Delivery System I: Synthesis and Some Properties of the Dihydropyridine Derivatives," (XXVII in Improved Delivery Series), J. Pharm. Sci., 78(8), 609-616 (1989).

181. E. Pop, W. Wu and Nicholas Bodor, "Improved Delivery Through Biological Membranes XL. Chemical Delivery Systems for Some Penicillinase-Resistant Semisynthetic Penicillins," J. Med. Chem., 32, 1789-1795 (1989).

182. E. Pop, W. Wu, E. Shek and N. Bodor, "Chemical Delivery Systems for Drugs Containing an Amino Group: Synthesis and Properties of Some Pyridine Derivatives of Desipramine," (Improved Delivery Through Biological Membranes. XLII), Drug Des. & Del., 5, 93-115 (1989).

183. E. Pop, W. Wu, E. Shek and N. Bodor, "Improved Delivery Through Biological Membranes XXXVIII. Brain-Specific Chemical Delivery Systems for β-Lactam Antibiotics. Synthesis and Properties of Some Dihydropyridine and Dihydroisoquinoline Derivatives of Benzylpenicillin," J. Med. Chem., 32, 1774-1781 (1989).

184. L. Prokai, B. Hsu, H. Farag and N. Bodor, "Desorption Chemical Ionization, Thermospray, and Fast Atom Bombardment Mass Spectrometry of Dihydropyridine _ Pyridinium Salt- Type Redox Systems," Anal. Chem., 61, 1723-1728 (1989).

185. M. Rahimy, N. Bodor and J. Simpkins, "A Rapid, Sensitive Method for the Simultaneous Quantitation of Estradiol and Estradiol Conjugates in a Variety of Tissues: Assay Development and Evaluation of the Distribution of a Brain-Enhanced Estradiol-Chemical Delivery System," J. Steroid Biochem., 33, 179-187 (1989).

186. E. Shek, T. Murakami, C. Nath, E. Pop and N. Bodor, "Improved Anticonvulsant Activity of Phenytoin by a Redox Brain Delivery System: Brain Uptake and Pharmacological Effects," (XXIX in Improved Delivery Series), J. Pharm. Sci., 78(10), 837-843 (1989).

187. A. Simay, L. Prokai and N. Bodor, "Oxidation of Aryloxyaminoalcohols with Activated Dimethylsulfoxide: A Novel C-N Oxidation, Facilitated by Neighboring Group Effect," Tetrahedron, 45(13), 4091-4102 (1989).

188. J. Simpkins, W. Anderson, R. Dawson, Jr., and N.Bodor, "Effects of a Brain-Enhanced Chemical Delivery System for Estradiol on Body Weight and Food Intake in Intact and Ovariectomized Rats," Pharm. Res., 6(7), 592-600 (1989).

189. J. Simpkins, M. Rahimy, W. Anderson, W. Millard and N. Bodor, "A Brain-Enhanced Delivery System for Gonadal Steroids: Implication for Neurogenerative Diseases," Chapter in Novel Procedures for the Treatment of Alzheimer's Disease, E. Meyer, J. Simpkins, Eds., Plenum Press, New York, 197-212 (1989).

190. W. Wu, E. Pop, E. Shek and N. Bodor, "Improved Delivery Through Biological Membranes. 39. Brain-Specific Chemical Delivery Systems for β-Lactam Antibiotics. In Vitro and In Vivo Studies of Some Dihydropyridine and Dihydroisoquinoline Derivatives of Benzylpenicillin in Rats," J. Med. Chem., 32, 1782-1788 (1989).

191. N. Bodor, M. Brewster and J. Kaminski, "Reactivity of Biologically Important Reduced Pyridines III. Energetics and Mechanism of Hydride Transfer Between 1-Methyl1,4- Dihydronicotinamide and the 1-Methylnicotinamide Cation, A Theoretical Study," J. Mol. Struct. (THEOCHEM), 206, 315-334 (1990).

192. N. Bodor, A. ElKoussi and R. Hammer, "Soft Drug 9. The Ultra-Short Duration of the Muscarinolytic Activity of a New Short-Acting 'Soft' Mydriatic Agent," J. Pharm. Biopharm. Sci., 1(3), 215-223 (1990).

193. N. Bodor and T. Loftsson, "The Effect of Phosphine Oxides on Transdermal Delivery," Acta Pharm. Nordica, 123-126 (1990).

194. N. Bodor and L. Prokai, "Site- and Stereospecific Ocular Drug Delivery by Sequential Enzymatic Bioactivation," Pharm. Res., 7(7), 723-725 (1990).

195. N. Bodor and M. Varga, "Effect of a Novel Soft Steroid on the Wound Healing of Rabbit Cornea," Exp. Eye Res., 50(2), 183-187 (1990).

196. M. Brewster, M. Deyrup, K. Czako and N. Bodor, "Extension of a Redox-Based Delivery System to α,β-Unsaturated Ketones," (Improved Delivery Series XXXVI), J. Med. Chem., 33, 2063-2065 (1990).

197. M. Brewster, K. Estes and N. Bodor, "An Intravenous Toxicity Study of 2-Hydroxypropyl- β-Cyclodextrin (A Useful Drug Solubilizer) in Rats and Monkeys," Int. J. Pharm., 59, 231- 243 (1990).

198. M. Brewster, J. Kaminski, Z. Gabanyi, K. Czako, Agnes Simay and N. Bodor, "Reactivity of Biologically Important Reduced Pyridines VI. Lack of Through-Resonance Stabilization in the Ferricyanide-Mediated Oxidation of Substituted 1-Phenyl-1,4Dihydronicotinamides," Tetrahedron, 46(2), 319-324 (1990).

199. M. Brewster, J. Kaminski, M. Huang and N. Bodor, "Reactivity of Biologically Important Reduced Pyridines 7. Energetics and Effect of Substitution on Hydride Versus Electron Transfer in Dihydropyridines, Dihydroquinolines and Dihydroisoquinolines," J. Org. Chem., 33, 2361-2366 (1990).

200. M. Brewster, J. Simpkins and N. Bodor, "Brain-Targeted Delivery of Estrogens," Reviews in the Neurosciences, 2(4), 241-285 (1990).

201. K. Dietzel, K. Estes, M. Brewster, N. Bodor and H. Derendorf, "The Use of Hydroxypropyl- β-Cyclodextrin as a Vehicle for Intravenous Administration of Dexamethasone in Dogs," Int. J. Pharm., 59, 225-230 (1990).

202. K. Dietzel, V. Keuth, K. Estes, M. Brewster, R. Clemmons, Richard Vistelle, N. Bodor and H. Derendorf, " A Redox-Based System That Enhances Delivery of Estradiol to the Brain: Pharmacokinetic Evaluation in the Dog," Pharm. Res., 7(8), 879-883 (1990).

203. P. Druzgala and N. Bodor, "Selective 17α-Alkylation of Cortinenic Acid Derivatives in a Solid-Liquid Biphasic System," Synth. Com., 20(8), 1133-1141 (1990).

204. K. Estes, M. Brewster, A. Webb and N. Bodor, "A Non-Surfactant Formulation for Alfaxalone Based on an Amorphous Cyclodextrin: Activity Studies in Rats and Dogs," Int. J. Pharm., 65, 101-107 (1990).

205. J. Kaminski and N. Bodor, "Chemical Approaches for Site-Specific Drug Delivery," Chapter in Modern Drug Discoveries Technologies," C. Clark and W. Moos, Eds. Horwood Publishers, Spring/Summer (1990).

206. R. Little, D. Bailey, M. Brewster, K. Estes, R. Clemmons, A. Saab and N. Bodor, "Improved Delivery Through Biological Membranes XXXIII. Brain Enhanced Delivery of Azidothymidine (AZT)," J. Biopharm. Sci., 1(1), 001-018 (1990).

207. W. Millard, T. Romano, N. Bodor and J. Simpkins, "GH Secretory Dynamics in Animals Administered Gonadal Steroids Utilizing a Chemical Delivery System," Pharm. Res., 7(10), 1011-1018 (1990).

208. E. Pop, W. Anderson, K. Prokai-Tatrai, M. Brewster, M. Fregly and N. Bodor, "Antihypertensive Activity of Redox Derivatives of Tryptophan," (Improved Delivery Through Biological Membranes. 50), J. Med. Chem., 33, 2216-2221 (1990).

209. E. Pop, M. Brewster and N. Bodor, "Central Nervous System-Enhanced Delivery of β- Lactam Antibiotics," Drugs of the Future, 15(5) 473-492 (1990).

210. E. Pop, T. Loftsson and N. Bodor, "Novel Central Nervous System Targeted Semisynthetic Penicillins," (Improved Delivery Through Biological Membranes XLIII), Drug Des. & Del., 5, 221-237 (1990).

211. E. Pop, K. Prokai-Tatrai, W. Anderson, J. Lin, M. Brewster and N. Bodor, "Application of a Brain-Specific Chemical Delivery System Approach to Tranylcypromine," Eur. J. Pharmacol., 183, 1909 (1990).

212. E. Pop, K. Prokai-Tatrai, J. Scott, M. Brewster and N. Bodor, "Improved Delivery Through Biological Membranes. 49. Application of a Brain-Targeting Chemical Delivery System to 9-Amino-1,2,3,4-Tetrahydroacridine," Pharm. Res., 7(6) 658-664 (1990).

213. B. Radhakrishnan, D. Winwood and N. Bodor, "A Convenient Preparation of Phosphate Diester Monoanions," Synth. Com., 20(17), 2654-2658 (1990).

214. M. Rahimy, J. Simpkins and N. Bodor, "Dose and Time-Course Evaluation of a Redox- Based Estradiol-Chemical Delivery System for the Brain. I. Tissue Distribution," Pharm. Res., 7, 1061-1067 (1990).

215. M. Rahimy, J. Simpkins and N. Bodor, "Dose and Time-Course Evaluation of a Redox- Based Estradiol-Chemical Delivery System for the Brain. II. Pharmacodynamic Responses," Pharm. Res., 1107-1112 (1990).

216. M. Rahimy, J. Simpkins and N. Bodor, "Tissue Distribution of a Brain-Enhanced Chemical Delivery System for Estradiol," Drug Des. & Del., 6, 29-40 (1990).

217. P. Woodard, D. Winwood, M. Brewster, K. Estes and N. Bodor, "Improved Delivery Through Biological Membranes XXI. Brain-Targeted Anticonvulsive Agents," Drug Des. & Del., 6, 15-28 (1990).

218. N. Bodor, "Soft Drugs," in Enc. of Human Biol., 7, Academic Press, Harcourt Brace Jovanovich, Publishers, San Diego, 101-117 (1991).

219. N. Bodor and M. Brewster, "Chemical Delivery Systems," chapter 7 in Handbook of Experimental Pharmacology, 100, Targeted Drug Delivery, R. Juliano Ed., Springer-Verlag, Berlin Heidelberg, 231-284 (1991).

220. N. Bodor, S. Buris and L. Buris, "Novel Soft Steroids: Effects on Cell Growth In Vitro and on Wound Healing in the Mouse," Steroids, 56, 434-439 (1991).

221. N. Bodor and P. Chikhale, "Improved Delivery of Acyclovir to the Skin Using a Dihydrotigonelline _ Trigonelline Redox Carrier," (XLVII in Improved Delivery Series), J. Pharm. Sci., 80(4), 402-403 (1991).

222. N. Bodor and A. ElKoussi, "Improved Delivery Through Biological Membranes LVI. Pharmacological Evaluation of Alprenoxime - A New Potential Antiglaucoma Agent," Pharm. Res., 8(11), 1389-1395 (1991).

223. N. Bodor, A. Harget and M. Huang, "Neural Network Studies. 1. Estimation of the Aqueous Solubility of Organic Compounds," J. Amer. Chem. Soc., 113, 9480-9483 (1991).

224. N. Bodor and M. Huang, "Predicting Partition Coefficients for Isomeric Diastereoisomers of Some Tripeptide Analogs," J. Comp. Chem., 12(9), 1182-1186 (1991).

225. N. Bodor, W. Wu and J. Larsen, "Effect of Cyclodextrins on the Solubility and Stability of Loteprednol Etabonate: A Novel, Soft Corticosteroid," Pharm. Sci. Comms., submitted for publication (1991).

226. M. Alberth, W. Wu, D. Winwood and N. Bodor, "Lipophilicity, Solubility and Permeability of Loteprednol Etabonate: Novel Soft Anti-inflammatory Corticosteroid," J. Biopharm. Sci., 2(2), 115-125 (1991).

227. W. Anderson, E. Pop, S. Lee, M. Bhagrath, N. Bodor and M. Brewster, "Brain-Targeting Chemical Delivery Systems for Adenosine Depresses Locomotor Behavior in Rats," Med. Chem. Res., 1, 74-79 (1991).

228. W. Anderson, M. Rahimy, M. Brewster, N. Bodor and J. Simpkins, "The Effects of a Brain- Enhanced Estradiol Delivery System on Androgen and Androgen-Dependent Tissues. II. Assessment of the Testosterone Role," Endocrinol., 129(2), 726-733 (1991).

229. M. Bhagrath, R. Sidwell, K. Czako, K. Seyda, W. Anderson, N. Bodor and M. Brewster, "Improved Delivery Through Biological Membranes 54. Synthesis, Characterization and Antiviral Activity of a Series of Ribavirin Chemical Delivery Systems: 5' and Carboxamide Derivatives," Antiviral Chem. & Chemo., 2(5), 265-286 (1991).

230. M. Brewster, W. Anderson and N. Bodor, "Brain, Blood and Cerebrospinal Fluid Distribution of an Azidothymidine Chemical Delivery System in Rabbits," (Improved Delivery Through Biological Membranes. 52), Pharm. Res., 80(9) 843-846 (1991).

231. M. Brewster, W. Anderson, K. Estes and N. Bodor, "Development of Aqueous Parenteral Formulations for Carbamazepine Through the Use of Modified Cyclodextrins," J. Pharm. Sci., 80, 380-383 (1991).

232. M. Brewster, W. Anderson, K. Estes and N. Bodor, "Simple Reduced Nicotinamide Derivatives Exert Potent Anticonvulsant Activity," Med. Chem. Res., 1, 80-85 (1991).

233. M. Brewster, M. Deyrup, K. Seyda and N. Bodor, "Synthesis, Characterization and In Vitro Evaluation of Various Sulfonamide Chemical Delivery Systems," (Improved Delivery Through Biological Membranes. 46), Int. J. Pharm., 68, 215-229 (1991).

234. M. Brewster, D. Doerge, M. Huang, J. Kaminski, E. Pop and N. Bodor, "Application of Semiempirical Molecular Orbital Techniques to the Study of Peroxidase-Mediated Oxidation of Phenols, Anilines, Sulfides and Thiobenzamides," Tetrahedron, 47(36), 7525- 7536 (1991).

235. M. Brewster, M. Hora, J. Simpkins and N. Bodor, "Use of 2-Hydroxypropyl-β-cyclodextrin as a Solubilizing and Stabilizing Excipient for Protein Drugs," Pharm. Res., 8(6), 792-795 (1991).

236. M. Brewster, M. Huang and N. Bodor, "Reactivity of Biologically Important Reduced Pyridines IX. Effects of Substitution on Rotational Barriers in 1-Phenyl-1,4-dihydropyridine

and the 1-Phenylpyridinium Cation and Related Systems," J. Mol. Struct. (THEOCHEM), 257, 49-56 (1991).

237. M. Brewster, M. Huang, J. Kaminski, E. Pop and N. Bodor, "Reactivity of Biologically Important Reduced Pyridines VIII. Use of Semiempirical Parameters to Probe Oxidative Conversion in a Series of 3-Substituted 1-Methyl-1,4 Dihydropyridines," J. Comp. Chem., 12, 1278-1282 (1991).

238. M. Brewster, M. Huang, J. Kaminski, E. Pop and N. Bodor, "Use of Semiempirical Molecular Orbital Parameters to Probe Dihydropyridine Stability - Implications to Brain- Targeting Chemical Delivery Systems," Rev. Roumaine Chim., 36, 647-656 (1991).

239. M. Brewster, T. Loftsson, J. Baldvinsdottir and N. Bodor, "Stabilization of Aspartame by Cyclodextrins," J. Int. Pharm., 75, R5-R8 (1991).

240. M. Deyrup, R. Sidwell, R. Little, P. Druzgala, N. Bodor and M. Brewster, "Improved Delivery Through Biological Membranes [55]. Synthesis and Antiviral Activity of a Series of Ribavirin Chemical Delivery Systems: 2' and 3' Derivatives," Antiviral Chem. & Chemo., 2(6), 337-355 (1991).

241. P. Druzgala and N. Bodor, "Regioselective Alkylation of Cortienic Acid and Synthesis of a New Class of Glucocorticoids Containing A 17α-Alkoxy, A 17α-(1'-Alkoxyethyloxy), A 17,α-Alkoxymethyloxy, or A 17α-Methylthiomethyloxy Function," Steroids, 56, 490-494 (1991).

242. P. Druzgala, G. Hochhaus and N. Bodor, "Soft Drugs--10. Blanching Activity and Receptor Binding Affinity of a New Type of Glucocorticoid: Loteprednol Etabonate," J. Steroid Biochem., 38(2), 149-154 (1991).

243. P. Druzgala, W. Wu and N. Bodor, "Ocular Absorption and Distribution of Loteprednol Etabonate, A Soft Steroid in Rabbit Eyes," Cur. Eye Res., 10(10), 933-937 (1991).

244. K. Estes, P. Dewland, M. Brewster, H. Derendorf and N. Bodor, "A Redox-Based Chemical Delivery System (CDS) Applied to Estradiol," Pharm. Zeit. Wissen., 153-158 (1991).

245. K. Estes, V. Keuth, K. Dietzel, M. Brewster, N. Bodor and H. Derendorf, "A Redox-Based Chemical Delivery System That Enhances Estradiol to the Brain: Disposition Studies in the Rat," Pharm. Res., 8(9), 1180-1185 (1991).

246. R. Hammer, W. Wu J. Sastry and N. Bodor, "Short Acting Mydriatics," Cur. Eye Res., 10(6), 565-570 (1991).

247. G. Hochhaus, P. Druzgala, R. Hochhaus, J. Huang and N Bodor, "Glucocorticoid Activity and Structure Activity Relationships in a Series of Some Novel 17-α-Ether-Substituted Steroids: Influence of 17-α Substituents," Drug Des. & Del., 8, 117-125 (1991).

248. T. Loftsson, M. Brewster, H. Derendorf and N. Bodor, "2-Hydroxypropyl-β-cyclodextrin: Properties and Usage in Pharmaceutical Formulations," Pharm. Zeitung, 1, 5-10 (1991).

249. T. Loftsson, B. Olafsdottir and N. Bodor, "The Effects of Cyclodextrins on Transdermal Delivery of Drugs," Eur. J. Pharm. Biopharm., 37(1), 30-33 (1991).

250. S. Nishitani and N. Bodor, "Polymer Supported 1-Benzyl-1,2-Dihydroisonicotinamides as Reducing Agents," Rev. Roumaine Chim., 36, 635-645 (1991).

251. P. Polgar and N. Bodor, "Cardiac Electrophysiologic Effects of Adaprolol Maleate, a New β- Blocker, in Closed Chest Dogs," (Soft Drugs 11), Life Sci., 48(16), 1519-1528 (1991).

252. E. Pop, W. Anderson, M. Brewster and N. Bodor, "Enhanced onamine Oxidase Inhibitor Activity of Tranylcypromine," Med. Chem. Res., 1, 230-234 (1991).

253. E. Pop, W. Anderson, K. Prokai-Tatrai, M. Brewster and N. Bodor, "Redox Analogs of Centrally Acting Amines: Design, Synthesis and Properties of a Tranylcypromine Derivative with a Potentially Enhanced Therapeutic Index," (Improved Delivery Through Biological Membranes. 53), J. Biopharm. Sci., 2(1), 11-23 (1991).

254. E. Pop, M. Brewster and N. Bodor, "Improved Central Nervous System Delivery and Activity of Antiepileptic Drugs," Drugs of the Future, 16(3), 221-248 (1991).

255. E. Pop, M. Brewster and N. Bodor, "Site Specific Delivery of the Central Nervous System Acting Amines," Drugs of the Future, 16(10), 919-944 (1991).

256. E. Pop, M. Huang, N. Bodor, S. Bercovici and S. Shatzmiller, "Ionic and Radical Intermediates of 3-Substituted 5,6-Dihydro-1,4,2-Dioxazines; A Theoretical (AM1) Study," J. Mol. Struct. (THEOCHEM), 235, 343-353 (1991).

257. E. Pop, M. Huang, S. Matei, M. Brewster and N. Bodor, "Electrophilic Substitution in the Benzofuran Series: A Theoretical (AM1) Study," Int. J. Quant. Chem.: Quant. Chem. Symp., 25, 325-333 (1991).

258. E. Pop, T. Loftsson and N. Bodor, "Solubilization and Stabilization of a Benzylpenicillin Chemical Delivery System by 2-Hydroxypropyl-β-Cyclodextrin," Pharm. Res., 8(8) 1044- 1049 (1991).

259. K. Prokai-Tatrai, E. Pop, W. Anderson, J. Lin, M. Brewster and N. Bodor, "Redox Derivatives of Tranylcypromine: Syntheses, Properties and Monoamine Oxidase Inhibitor Activity of Some Chemical Delivery Systems and Novel Analogs," (Improved Delivery Through Biological Membranes. 51), J. Pharm. Sci., 80(3), 255-261 (1991).

260. K. Prokai-Tatrai, E. Pop, W. Anderson, J. Lin, M. Brewster and N. Bodor, "Redox Derivatives of Tranylcypromine: Syntheses, Properties and Monoamine Oxidase Inhibitor Activity of Some Chemical Delivery Systems and Novel Analogs," (Improved Delivery Through Biological Membranes. 51), selected to be published in recognition of excellence in Clinical Digest Series (1991).

261. L. Prokai and N. Bodor, "Reversed-Phase High-Performance Liquid Chromatography - Thermospray Mass Spectrometry of Alprenolol and Its Ketoxime Analogues," J. Chromatog., 541, 474-479 (1991).

262. L. Prokai, E. Koltai and N. Bodor, "Isolation and Characterization of Amine(N-B)- Aminoborane Internal Complexes and a Cyclic Diaminoborane as Intermediates of the Borane Reduction of Hexahydro-1H-Imidazo[2,1-d][1,2,5] dithiazepines, J. Am. Chem. Soc., submitted for publication (1991).

263. L. Prokai, A. Simay and N. Bodor, "Reversed-Phase High-Performance Liquid Chromatography and Liquid Chromatography of Ketoxime Analogues of β-Adrenergic Blockers," J. of Chromatog., 541, 469-473 (1991).

264. M. Rahimy, W. Anderson, M. Brewster, N. Bodor and J. Simpkins, "The Effects of Brain- Enhanced Estradiol Delivery System on Androgen and Androgen-Dependent Tissues. I. Dose-Response and Time-Course Evaluation," Endocrinol., 129, 717-725 (1991).

265. M. Rahimy, N. Bodor and J. Simpkins, "Effects of a Brain-Enhanced Estrogen Delivery System on Tail-Skin Temperature of the Rat: Implications for Menopausal Hot Flush," Maturitas, 13, 51-63 (1991).

266. M. Rahimy, N. Bodor and J. Simpkins, "Prolonged Suppression of Androgens and Androgen-Dependent Tissues by a Brain-Enhanced Estrogen Delivery System in the Rat," J. Biopharm. Sci., accepted for publication (1991).

267. W. Wu, E. Pop, E. Shek, R. Clemmons and N. Bodor, "Brain and CSF Specific Chemical Delivery Systems for β-Lactam Antibiotics. In Vitro and In Vivo Studies of Dihydropyridine Derivatives of Benzylpenicillin in Rabbits and Dogs," (Improved Drug Delivery Series 48), Drug Des. & Del., 7, 33-43 (1991).

268. N. Bodor, "New Methods of Drug Targeting," chapter in Trends in Medicinal Chemistry '90, S. Sarel, R. Mechoulam and I. Agranat, Eds., Blackwell Scientific Publications, 35-44 (1992).

269. N. Bodor, Nicole Bodor and W. Wu, "A Comparison of Intraocular Pressure Elevating Activity of Loteprednol Etabonate and Dexamethasone in Rabbits," Cur. Eye Res., 11(6), 525-530 (1992).

270. N. Bodor and A. ElKoussi, "A New Ocular Site-Specific Chemical Delivery System for Antiglaucoma Drugs," S.T.P Pharma Sciences, 2(1), 61-67 (1992).

271. N. Bodor and M. Huang, "An Extended Version of a Novel Method for the Estimation of Partition Coefficients," J. Pharm. Sci., 81(3), 272-281 (1992).

272. N. Bodor and M. Huang, "Intermolecular Interactions of Methyl Acetate, β-Propiolactone, Ethyl Acetate and γ-Butyrolactone: An AM1 Study," Int. J. Quantum Chem., 44, 81-89 (1992).

273. N. Bodor and M. Huang, "A New Method for the Estimation of the Aqueous Solubility of Organic Compounds," J. Pharm. Sci., 81(9), 954-960 (1992).

274. N. Bodor and M. Huang, "Optimized Structures and Relative Stabilities of the Isomers of (CO2)2n=1(1≤n6≤) from AM1 Calculations," Chem. Physics Letters, 192(4), 386-389 (1992).

275. N. Bodor, M. Huang and A. Harget, "Neural Network Studies. 4. An Extended Study of the Aqueous Solubility of Organic Compounds," Int. J. Quan. Chem.: Quant Chem. Symp., 26, 853-867 (1992).

276. N. Bodor, M. Huang, C, Szantay and C. Szantay, Jr., "On the Reactivity of CFnH3-n CH2X (n = 0,1,2, and 3, and X = H or Halogen Atom)," Tetrahedron, 48(28), 5823-5830 (1992).

277. N. Bodor, E. Koltai and L. Prokai, "Borohydride Reduction of Imidazolidino[1,2- d]dithiazepines+," Tetrahedron, 48(23), 4767-4772 (1992).

278. N. Bodor, T. Loftsson and W. Wu, "The Metabolism, Distribution and Transdermal Permeation of a Soft Corticosteroid, Loteprednol Etabonate," Pharm. Res., 9(10), 1275-1278 (1992).

279. N. Bodor and L. Prokai, "Intermediates of the Borane Reduction of Some Imidazolidines: An AM1 Study," Int. J. Quantum Chem., 44, 795-805 (1992).

280. N. Bodor, L. Prokai, W. Wu, H. Farag, S. Jonnalagadda, M. Kawamura and J. Simpkins, "A Strategy for Delivering Peptides into the Central Nervous System by Sequential Metabolism," Science, 257, 1698-1700 (1992).

281. D. Bailey, R. Perchalski, M. Bhagrath, E. Shek, D. Winwood and N. Bodor, "Synthesis of Pyridinium Salt Derivatives of 1,1'-[[1-{Aminomethyl}-1,2-Ethandediyl]Diimino]Bis[2-Met hyl-2 -Propanethiol]: Potential Brain Specific Ligands Tc-99m Complexes," J. Biopharm. Sci., 2(3), 205-218 (1992).

282. M. Brewster, W. Anderson and N. Bodor, "Enhanced Brain Delivery of Amino Acids and Peptides Through the Use of Redox Targeting Systems," in Treatment of Dementias: A New Generation of Progress, E. Meyer, J. Simpkins and J. Yamamoto, Eds., Plenum Press, New York, 301-316 (1992).

283. M. Brewster and N. Bodor, "Parenteral Safety and Applications of 2-Hydroxypropyl-β- Cyclodextrin," In Proceedings of the Fifth International Symposium on Cyclodextrins, D. Duchene, Ed., Editions de Sante Publishers, Paris, 315-350 (1992).

284. M. Brewster and N. Bodor, "Redox Approaches to Drug Delivery to the Central Nervous System," NIDA Research Monograph Series, Bioavailability of Drugs to the Brain and the Blood-Brain Barrier, J. Frankenheim and R. Brown, Eds., 120, 169-201 (1992).

285. M. Brewster, M. Huang, A. Harget and N. Bodor, "Neural Network Studies 2. Use of a Neural Net to Estimate Oxidation Energies for Substituted Dihydropyridines and Related Heterocycles," Tetrahedron, 48(17), 3463-3472 (1992).

286. N. Brewster, T. Loftsson, K. Estes, J. Lin and N. Bodor, "Effect of Various Cyclodextrins on Solution Stability and Dissolution Rate of Doxorubicin Hydrochloride," Int. J. Pharm., 79(2- 3), 289-299 (1992).

287. P. Druzgala, D. Winwood, M. Drewniak-Deyrup, S. Smith, N. Bodor and J. Kaminski, "New Water Soluble Pilocarpine Derivatives with Enhanced and Sustained Muscarinic Activity," Pharm. Res., 3, 372-377 (1992).

288. A. Harget and N. Bodor, "Computer-Aided Drug Design: A Neural Network Approach," Pers. Comps. & Intel. Sys., F. Vogt, Ed., Elsevier Science Publishers, North Holland, 252- 258 (1992).

289. G. Hochhaus, L. Chen, A. Ratka, P. Druzgala, J. Howes, N. Bodor and H. Derendorf, "Pharmacokinetic Characterization and Tissue Distribution of the New Glucocorticoid Soft Drug Loteprednol Etabonate in Rats and Dogs," J. Pharm. Sci., 81, 1210-1215 (1992).

290. M. Huang and N. Bodor, "Structure Studies of Bitetrahedryl Molecule C8H6, Coupled Tricyclo[3.1.0.0]Hexyl Molecule C12H14, and Coupled Bicyclo[1.1.0]Butane Derivatives," Chem. Physics Letters, 190(1,2), 25-28 (1992).

291. E. Pop, W. Anderson, K. Prokai-Tatrai, J. Vlasak, M. Brewster and N. Bodor, "Syntheses and Preliminary Pharmacological Evaluation of Some Chemical Delivery Systems of 2,6- Diisopropylphenol (Propofol)," Med. Chem. Res., 2, 16-21 (1992).

292. E. Pop, W. Anderson, J. Vlasak, M. Brewster and N. Bodor, "Enhanced Brain Delivery of 2'- Fluoro-5-Methylarabinosyluracil," (Improved Delivery Through Biological Membranes. LVII.), Int. J. Pharm., 84, 39-48 (1992).

293. E. Pop and N. Bodor, "Chemical Systems for Delivery of Antiepileptic Drugs to the Central Nervous System," Epilepsy Res., 13, 1-16 (1992).

294. E. Pop, M. Brewster, W. Anderson and N. Bodor, "Biodistribution of Azidothymidine Mediated by a Highly Lipophilic Chemical Delivery System," Med. Chem. Res., 2, 457-466 (1992).

295. E. Pop, M. Huang, M. Brewster and N. Bodor, "A Theoretical Study of the Hydrolysis of Some Sterically Hindered Phenolic Esters," Int. J. Quant. Chem.: Quant. Biol. Symp., 19, 77- 85 (1992).

296. K. Raghavan, T. Loftsson and N. Bodor, "Improved Delivery Through Biological Membranes XLV: Synthesis, Physical-Chemical Evaluation, and Brain Uptake Studies of 2-Chloroethyl Nitrosourea Delivery Systems," Pharm. Res., 9(6), 743-749 (1992).

297. M. Rahimy, N. Bodor and J. Simpkins, "Evaluation of a Novel Redox-Based Estrogen Chemical Delivery System for the Brain," Trends in Medicinal Chemistry '90, S. Sarel, R. Mechoulam and Agranat, Eds., Blackwell Scientific Publications, 369-376 (1992).

298. A. Simay and N. Bodor, "Site- and Stereospecific Drug Delivery to the Eye," Trends in Medicinal Chemistry '90, S. Sarel, R. Mechoulam and I.Agranat, Eds., Blackwell Scientific Publications, 361-368 (1992).

299. J. Simpkins and N. Bodor, "Brain-Enhanced Drug Delivery Systems for the Treatment of Dementia," Chapter 4 in Alzheimer's Disease, Z. Khachaturian and J. Blass, Eds., Marcel Dekker, Inc., New York, 37-55 (1992).

300. J. Simpkins and N. Bodor, "Brain Targeted Delivery of Neurotransmitters: Use of a Redox Based Chemical Delivery System," chapter in The Treatment of Dementias, A New Generation of Progress, E. Meyer, J. Simpkins, F. Crews and J. Yamamoto, Eds., Plenum Press, New York, 317-331 (1992).

301. J. Simpkins, M. Rahimy and N. Bodor, "Enhanced Brain Delivery of Steroids and Neurotransmitters," Proc. of 18th Intl. Symp. of Controlled Release of Bioactive Materials, in press (1992).

302. N. Bodor, "Design of Novel Soft Corticosteroids," in Topical Glucocorticoids with Increased Benefit-Risk Ratio, Vol. 21 of Cur. Probl. Dermatol., H. Korting, Ed., 11-19 (1993).

303. N. Bodor, "Soft Drugs," Hung. Chem. J., 2, 45-58 (1993).

304. N. Bodor and M. Brewster, "Chemical Approaches to Brain-Targeting of Biologically Active Compounds," chapter in Organic Chemistry for the Neurosciences, A. Kozikowski, Ed., Raven Press, 435-467 (1993).

305. N. Bodor, M. Huang and J. Kaminski, "A Theoretical Study of Prednisolone, 6α- Flouroprednisolone, 9α-Flouroprednisolone, 6α,9α-Difluoroprednisolone and Related Compounds," J. Mol. Struct. (THEOCHEM), 279, 59-69 (1993).

306. C. Betlach, M. Gonzalez, B. McKiernan, C. Neff-Davis and N. Bodor, "The Oral Pharmacokinetics of Carbamazepine in Dogs from Commercial Tablets and a Cyclodextrin Complex," J. Pharm. Sci., 82(10), 1058-1060 (1993).

307. M. Brewster, M. Huang, E. Pop and N. Bodor, "Hydroxyl Stretching in Substituted Phenols: An AM1 Study," Int. J. Quant. Chem.: Quant Biol. Symp., 20, 7-15 (1993).

308. M. Brewster, M. Huang, E. Pop, J. Pitha, M. Dewar, J. Kaminski and N. Bodor, "An AM1 Molecular Orbital Study of α-D-Glucopyranose and β-Maltose: Evaluation and Implications," Carbohydrate Res., 242, 53-67 (1993).

309. M. Brewster, E. Pop and N. Bodor, "Chemical Approaches to Brain-Targeting of Biologically Active Compounds," chapter 16 in Drug Des. for Neuroscience, A. Kozikowski, Ed., Raven Press, Ltd., New York, 435-467 (1993).

310. M. Brewster, E. Pop, A. Braunstein, A. Pop, P. Druzgala, W. Anderson, A. ElKoussi and N. Bodor, "The Effect of Dihydronicotinate N-Substitution on the Brain-Targeting Efficacy of a Zidovudine Chemical Delivery System," Pharm. Res., 10(9), 1356-1362 (1993).

311. R. Hammer, E. Gunes, G. Kumar, W. Wu, V. Srinivasan and N. Bodor, "Soft Drugs--XIV. Synthesis and Anticholinergic Activity of Soft Phenylsuccinic Analogs of Atropine," Bioorg. & Med. Chem., 1(3), 183-187 (1993).

312. G. Kumar, R. Hammer and N. Bodor, "Soft Drugs 12. Design, Syntheses, Stability and Evaluation of Soft Anticholinergics," Drug Des. & Discov., 10, 11-21 (1993).

313. G. Kumar, R. Hammer and N. Bodor, "Soft Drugs 13: Design and Evaluation of Phenylsuccinic Analogs of Scopolamine as Soft Anticholinergics," Drug Des. & Discov., 10, 1-9 (1993).

314. G. Kumar, R. Hammer, W. Wu and N. Bodor, "Soft Drugs 15. Mydriatic Activity of Phenylsuccinic Analogs of Methscopolamine and Transcorneal Penetration of Short Acting Mydiratics," Cur. Eye Res., 12(6), 501-506 (1993).

315. G. Kumar, R. Hammer and N. Bodor, "Soft Drugs 16. Design, Evaluation and Transdermal Penetration of Novel Soft Anticholinergics Based on Methatropine," Bioorg. & Med. Chem., 1(5), 327-332 (1993).

316. E. Pop, M. Brewster, M. Huang and N. Bodor, "Dihydropyridine Isomerisms in the Chemical Delivery System Series," Croat. Chem. Acta, 66(3-4), 531-537 (1993).

317. E. Pop, M. Brewster, M. Huang and N. Bodor, "Dithionite Reduction of Pyridinium Salts: An AM1 Study," J. Mol. Struct. (THEOCHEM), 283, 27-32 (1993).

318. E. Pop, M. Brewster, M. Huang and N. Bodor, "A Theoretical Study of Dithionite Reduction of Pyridinium Salts," Int. J. Quant. Chem.: Quant. Chem. Symp. 20, 17-24 (1993).

319. E. Pop, Z. Liu, J. Vlasak, W. Anderson, M. Brewster and N. Bodor, "A Dihydroisoquinoline Targetor-Based Acid Resistant Chemical Delivery System of Azidothymidine (AZT), Drug Del., 1, 143-149 (1993).

320. L. Prokai, K. Prokai-Tatrai, E. Pop, N. Bodor, J. Lango and J. Roboz, "Fast Atom Bombardment and Tandem Mass Spectrometry of Quaternary Pyridinium Salt-Type Tryptophan Derivatives," Org. Mass Spectrom., 28, 707-715 (1993).

321. M. Rahimy, N. Bodor and J. Simpkins, "Suppression of Plasma Testosterone and Prostate Carcinoma Size by a Redox-Based, Brain-Targeted Estrogen Delivery System in the Rat," The Prostate, 23, 79-90 (1993).

322. I. Reddy and N. Bodor, "Chemical Approaches to Design Ophthalmic Drugs," Ind. J. Pharm. Sci., 55(5), 163-167 (1993).

323. S. Yoon, N. Bodor and J. Simpkins, "Synthesis and In Vitro Dopaminergic Activity of (2'Aminoethyl)-1-Hydroxy-2-Pyridone Type Dopamine Analogs," Drug Des. & Discov., 10, 35-44 (1993).

324. N. Bodor, "Designing Safer Ophthalmic Drugs by Soft Drug Approaches," J. Ocular Pharmacol., 10(1), 3-15 (1994).

325. N. Bodor, "Drug Targeting and Retrometabolic Drug Design Approaches," Adv. Drug Del. Revs., 14, 157-166 (1994).

326. N. Bodor, "Optimizing Drug Targeting by Combination of Delivery Systems and Cyclodextrins," Proceedings of the 7th International Cyclodextrins Symposium, April 25-29, 1994, Tokyo, Japan, 3-12 (1994).

327. N. Bodor, A. Harget and M. Huang, "Neural Network Studies. Part 3. Prediction of Partition Coefficients," J. Mol. Struct. (Theochem), 309, 259-266 (1994).

328. N. Bodor and L. Prokai, "Delivery of Peptides into the Central Nervous System by Sequential Metabolism," in Peptides: Chemistry, Structure and Biology, (Proceedings of the Thirteenth American Peptide Symposium, Edmonton, Alberta, Canada, June 20-25, 1993), ESCOM Science, Leiden, The Netherlands , R.S. Hodges and J.A. Smith, Eds., 830-833 (1994).

329. W. Anderson, M. Brewster, E. Pop, K. Estes and N. Bodor, "Improvement of Parenteral Formulations for Traditional Antiepileptics," J. Parenteral Sci. Technol., 48(6), 333-335 (1994).

330. M. Brewster and N. Bodor, "Improved Brain Delivery of Antiviral Agents Through the Use of Redox Targeting," Adv. Drug Del. Revs., 14, 177-197 (1994).

331. M. Brewster, A. Braunstein, M. Bartruff, E. Pop and N. Bodor, "Solubilization and Electrochemical Stabilization of Substituted Phenols Through the Use of 2-Hydroxypropyl- β-cyclodextrin," Supramolecular Chem., 4, 69-76 (1994).

332. M. Brewster, C. Kibbey, M. Huang, E. Pop and N. Bodor, "Interaction of Substituted Phenols and 2-Hydroxypropyl-β-Cyclodextrin," Proceedings of the 7th International Cyclodextrins Symposium, April 25-28, 1994, Tokyo, Japan, 250-253 (1994).

333. M. Brewster, E. Pop, M. Huang and N. Bodor, "Contributions of Molecular Orbital Techniques to the Study of Dihydropyridines," Heterocycles, 37(2), 1373-1415 (1994).

334. M. Brewster, E. Pop, M. Huang and N. Bodor, "Rotational Barriers in Phenol and Sterically Congested Phenol Derivatives, an AM1 Study," J. Mol. Struct. (Theochem), 303, 25-38 (1994).

335. M. Brewster, V. Raghavan, E. Pop and N. Bodor, "Enhanced Delivery of Ganciclovir to the Brain through Use of Redox Targeting," Antimicrob. Agts. and Chemo., 38(4) 817-823 (1994).

336. M. Brewster, M. Scott, M. Bartruff, W. Anderson, P. Druzgala, N. Bodor and E. Pop," Effect of Molecular Manipulation on the Estrogenic Activity of a Brain-Targeted Estradiol Chemical Delivery System," J. Med. Chem., 37, 4237-4244 (1994).

337. P. Chikhale, E. Marvanyos and N. Bodor, "Improved Delivery Through Biological Membranes LXI: Design, Synthesis, and Evaluation of a Lipolol-Based Intradermal Drug Targeting System for 5-Flourouracil," Cancer Biother., 9(3), 245-252 (1994).

338. K. Estes, M. Brewster and N. Bodor, "Evaluation of an Estradiol Chemical Delivery System (CDS) Designed to Provide Enhanced and Sustained Hormone Levels in the Brain," in Adv. Drug Del. Revs., 14, 167-175 (1994).

339. M. Huang and N. Bodor, "Quantitative Structure-Inhibitory Activity Relationships of Substituted Phenols on Bacillus Subtilis Spore Germination," Int. J. Quant. Chem.: Quant. Biol. Symp. 21, 181-185 (1994).

340. G. Kumar, M. Huang, R. Hammer and N. Bodor, "Soft Drugs 17: Quantitative Structure- Activity Relationships of Soft Anticholinergics Based on Methatropine and Methscopolamine," J. Pharm. Sci., 83(1), 117-118 (1994).

341. T. Loftsson and N. Bodor, "The Pharmacokinetics and Transdermal Delivery of Loteprednol Etabonate and Related Soft Steroids," Adv. Drug Del. Revs., 14, 293-299 (1994).

342. A. Miyake and N. Bodor, "Improved Delivery Through Biological Membranes XXXV. Synthesis of Novel Bioreversible Redox Derivatives of Trifluorothymidine," Pharm. Sci. Comms., 4(4), 231-237 (1994).

343. F. Omar, H. Farag and N. Bodor, "Synthesis and Evaluation of a Redox Chemical Delivery System for Brain-Enhanced Dopamine Containing an Activated Carbamate-Type Ester," J. Drug Targeting, 2, 309-316 (1994).

344. E. Pop, M. Brewster, A. Dinculescu, M. Huang and N. Bodor, "Isomerism of Cephalosporin Esters; Theoretical and Practical Aspects," Heterocycles, 37(1), 477-486 (1994).

345. E. Pop, M. Brewster, K. Prokai-Tatrai and N. Bodor, "Novel Redox Derivatives of Tryptophan," Heterocycles, 38, 2051-2064 (1994).

346. E. Pop, M. Brewster, K. Prokai-Tatrai and N. Bodor, "Preparation of Redox Derivatives of 3α-Hydroxy-5α-Pregnane-11,20-Dione," OPPI Briefs, 26(3), 379-382 (1994).

347. E. Pop, M. Huang, M. Brewster and N. Bodor, "On the Mechanism of Cephalosporin Isomerization," J. Mol. Struct. (THEOCHEM), 315, 1-7 (1994).

348. E. Pop, M. Huang, M. Brewster and N. Bodor, "Stability of the 1,3-Substituted 1,4- Dihydropyridines; Substituent Effects on the Acid Catalyzed Hydration and Oxidation Reactions," Int. J. Quant. Chem.: Quant. Biol. Symp. 21, 173-180 (1994).

349. E. Pop, K. Prokai-Tatrai, M. Brewster and N. Bodor, "Analogs of Tryptophan," OPPI Briefs, 26(6), 687-690 (1994).

350. L. Prokai, X. Ouyang, W. Wu and N. Bodor, "Chemical Delivery System to Transport a Pyroglutamyl Peptide Amide to the Central Nervous System," J. Am. Chem. Soc., 116(6), 2643-2644 (1994).

351. I. Reddy and N. Bodor, "In Vitro Evaluation of a Controlled-Release, Site-Specific Diisovaleryl tert-Butalone Chemical Delivery System for the Eye," J. Pharm. Sci., 83(3), 450-453 (1994).

352. I. Reddy and N. Bodor, "Novel Approaches to Design and Deliver Safe and Effective Anti- glaucoma Agents to the Eye," Adv. Drug Del. Revs., 14, 251-267 (1994).

353. J. Simpkins and N. Bodor, "Enhanced Delivery of Steroids to the Brain Using a Redox- Based Chemical Delivery System," in Methods in Neurosciences, 22, R. de Kloet and W. Sutanto, Eds., 23-35 (1994).

354. J. Simpkins and N. Bodor," The Brain-Targeted Delivery of Dopamine Using a Redox Based Chemical Delivery System," Adv. Drug Del. Revs., 14, 243-249 (1994).

355. J. Simpkins, X. Ouyang, L. Prokai and N. Bodor, "Delivery of Peptides into the Central Nervous System by Molecular Packaging and Sequential Metabolism as a Method to Alter Neuropeptide Activity During Aging," Neuroprotocols, 4, 225-234 (1994).

356. N. Bodor, "Design of Biologically Safer Chemicals," Chemtech, October, 22-32 (1995).

357. N. Bodor, "Retrometabolic Approaches to Drug Targeting,"in NIDA Research Monograph Series, Membranes and Barriers: Targeted Drug Delivery, R. Rapaka, Ed., 154, 1-27 (1995).

358. N. Bodor, "Retrometabolic Drug Design Concepts in Ophthalmic Target-Specific Drug Delivery," Adv. Drug Del. Revs., 16, 21-38 (1995).

359. N. Bodor, "Targeted Drug Delivery to the Brain Using Chemical Delivery Systems," Proceedings of the AFMC International Medicinal Chemistry Symposium (AIMECS '95) Tokyo (Japan): 3-8 September 1995, Blackwell Science, Oxford, 183-190 (1995).

360. N. Bodor, "Targeting Drugs to the Brain by Sequential Metabolism," NIDA Research Monograph Series, Discovery of Novel Opioid Medications, R. Rapaka and H. Sorer, Eds., 147, 1-32 (1995).

361. N. Bodor, H. Farag and F. Omar, "Preparation, Preliminary Characterization and Complexation of a Crystalline Redox-Based Chemical Delivery System for Dopamine," Pharm. Sci., 1, 301-306 (1995).

362. N. Bodor and M. Huang, "Computer-Aided Design of New Drugs Based on Retrometabolic Concepts," chapter 7 in Computer Aided Molecular Design, ACS Symposium Series 589, C. Reynolds, M. Holloway and H. Cox, Eds., 98-113 (1995).

363. N. Bodor, M. Huang and J. Watts, "Theoretical Studies on the Structures of Natural and Alkylated Cyclodextrins," J. Pharm. Sci., 84(3), 330-336 (1995).

364. N. Bodor, T. Murakami, and W. Wu, "Soft Drugs 18. Oral Delivery of Loteprednol Etabonate, a Novel Soft Corticosteroid, in Rats - For Safer Treatment of Gastrointestinal Inflammation," Pharm. Res., 12(6), 869-874 (1995).

365. N. Bodor, T. Murakami, W. Wu, and S, Engel, "Soft Drugs 19. Rectal Application and Pharmacokinetics, Metabolism and Excretion of a Novel Soft Corticosteroid, Loteprednol Etabonate, in Rats," Pharm. Res., 12(6), 875-879 (1995).

366. N. Bodor and L. Prokai, "Molecular Packaging: Peptide Delivery to the Central Nervous System by Sequential Metabolism," chapter 14 in Peptide-Based Drug Design: Controlling Transport and Metabolism, M. Taylor and G. Amidon, Eds., ACS Professional Reference Book, 317-337 (1995).

367. N. Bodor, L. Prokai, W. Wu, G. Somogyi and H. Farag, "Sequential Bioactivation of Methoxime Analogs of β-Adrenergic Antagonists in the Eye," Proceedings of the annual Meeting of the Association for Ocular Pharmacology and Therapeutics in J. Ocular Pharmacol. & Ther., 11(3), 305-318 (1995).

368. S. Anselem, D. Friedman, A. Yogev, W. Anderson, D. Helton, N. Bodor, E. Pop and M. Brewster, "Formulation Development for a Zidovudine Chemical Delivery System: Towards Oral and Non-Parenteral Dosage Forms," Int. J. Pharm., 125, 31-43 (1995).

369. M. Brewster, W. Anderson, K. Estes, N. Bodor, E. Pop and J. Panetta, "Tissue Distribution of LY231617, An Antioxidant with Neuroprotectant Activity, in the Rat," J. Pharm. Sci., 84(7), 791-793 (1995).

370. M. Brewster, W. Anderson, D. Helton, N. Bodor and E. Pop, "Dose-Dependent Brain Delivery of Zidovudine Through the Use of a Zidovudine Chemical Delivery System," Pharm. Res., 12(5), 796-798 (1995).

371. M. Brewster, W. Anderson, T. Loftsson, N. Bodor and E. Pop, "Preparation, Characterization and Anesthetic Properties of 2-Hydroxypropyl-β-cyclodextrin Complexes of Pregnanolone and Pregnenolone in Rat and Mouse," J. Pharm. Sci., 84, 1154-1159 (1995).

372. M. Brewster and N. Bodor, "Passive and Facilitative Transport of Nucleobases, Nucleosides,and Oligonucleotides - Application to Antiviral and Other Therapies," NIDA Research Monograph Series, Membranes and Barriers: Targeted Drug Delivery, R. Rapaka, Ed., 154, 61-85 (1995).

373. M. Brewster, P. Druzgala, W. Anderson, M. Huang, N. Bodor and E. Pop, "Efficacy of a 3- Substituted versus 17-Substituted Chemical Delivery System for Estradiol Brain Targeting," J. Pharm. Sci., 84(1), 38-43 (1995).

374. M. Brewster, M. Huang, C. Browne, N. Bodor and E. Pop, "Relative Reactivity of 1,4- and 1,6-Dihydronicotinic Acid Derivatives to Radically Mediated Oxidation - A Theoretical and Experimental Evaluation," Int. J. Quant. Chem.: Quant. Biol. Symp., 22:161-170 (1995).

375. M. Brewster, M. Huang, E. Pop and N. Bodor, "Isomeric Interconversions in Tamoxifen and Related Compounds, An AM1 Study," Int. J. Quant. Chem., 53, 343-352 (1995).

376. M. Huang, D. Doerge, N. Bodor, E. Pop and M. Brewster, "Nitrogen Radical Cations as Intermediates in Enzymatically Mediated Oxidative Deaminations - Application of Molecular Parametric Models," Int. J. Quant. Chem.: Quant. Biol. Symp., 22:171-179 (1995).

377. A. Kourounakis, M. Badawi, N. Bodor and J. Simpkins, "Synthesis of Two Isosters of 4- Methylcatechol and Evaluation of Their NGF-Inducing Effect," Pharm. Sci., 1, 407-410 (1995).

378. A. Kourounakis and N. Bodor, "Quantitative Structure Activity Relationships of Catechol Derivatives on Nerve Growth Factor Secretion in L-M Cells," Pharm. Res., 12(8), 1199- 1204 (1995).

379. T. Loftsson and N. Bodor, "The Effect of Cyclodextrins on Percutaneous Transport of Drugs," chapter 13.1 in Percutaneous Penetration Enhancers, E. Smith and H. Maibach, Eds., CRC Press, Inc., Boca Raton, 335-342 (1995).

380. P. Polgar and N. Bodor, "Minimal Cardiac Electrophysiological Activity of Alprenoxime, A Site-Activated Ocular β-Blocker, in Dogs," Life Sci., 56(14), 1207-1213 (1995).

381. E. Pop, M. Brewster, M. Huang and N. Bodor, "Substituent Effects on the Stability of 1,4- Dihydropyridines," J. Mol. Struct. (THEOCHEM), 337, 49-55 (1995).

382. E. Pop, M. Huang, N. Bodor and M. Brewster, "Hydrolytic Stability of Allylic and Phenolic Esters of Some Synthetic Cannabinoids; A Theoretical (AM1) Study," Int. J. Quant. Chem.: Quant. Biol. Symp. 22., John Wiley & Sons, 137-143 (1995).

383. E. Pop, Z. Liu, J. Vlasak, W. Anderson, M. Brewster and N. Bodor, "Synthesis and Evaluation of a Novel Chemical Delivery System of Zidovudine with Increased Stability at Low pH," Pharm. Sci., 1, 265-269 (1995).

384. L. Prokai, W. Wu, G. Somogyi and N. Bodor, "Ocular Delivery of β-Adrenergic Antagonist Alprenolol by Sequential Bioactivation of Its Methoxime Analog," J. Med. Chem., 38(11), 2018-2020 (1995).

385. I. Reddy and N. Bodor, "Comparative Ocular Hypotensive Activity and In vivo Disposition of Dipivalyl Terbutalone in the Rabbit Model," Exp. Eye Res., submitted for publication (1995).

386. M. Saah and N. Bodor, "Evidence for Drug Binding via Enzyme Catalyzed Mixed Disulfide Linkages as a Probable Mechanism for Drug Targeting to Lung Tissue," J. Pharm. Sci., submitted for publication (1995).

387. H. Yang, W. Wu and N. Bodor, "Soft Drugs 20. Design, Synthesis and Evaluation of Ultra- Short Acting Beta-Blockers," Pharm. Res., 12(3), 329-336 (1995).

388. N. Bodor, "Design of Biologically Safer Chemicals Based on Retrometabolic Concepts," chapter 5 in Designing Safer Chemicals, III, ACS Books, R. Garrett and S. DeVito, Eds., ACS Symposium Series, 84-115 (1996).

389. N. Bodor, "The Use of Retrometabolic Drug Design Concepts in Ophthalmic Drug Discovery," in Ocular Therapeutics and Drug Delivery, I. Reddy, Ed., Technomic Publishing Company, Inc., Lancaster, PA, chapter 11, 335-361 (1996).

390. N. Bodor and P. Buchwald, "Estimating the Role of the van der Waals Molecular Size in Solute Partitioning," J. Pharm. Sci., submitted for publication (1996).

391. N. Bodor, A. ElKoussi, K. Zuobi and P. Kovacs, "Synthesis and Pharmacological Activity of Adaprolol Enantiomers: A New Soft Drug for Treating Glaucoma," J. Ocular Pharmacol. & Ther., 12(2), 115-122 (1996).

392. N. Bodor and M. Huang, "Computational Approaches to the Design of Safer Drugs and Their Molecular Properties," chapter 7 in Computational Chemistry: Reviews of Current Trends, Volume 1, J. Leszczynski Ed., World Scientific, Singapore, 219-266 (1996).

393. N. Bodor, M. Huang and J. Watts, "Theoretical AM1 Studies of Inclusion Complexes of α- and β-Cyclodextrins With Methylated Benzoic Acids and Phenol, and γ-Cyclodextrin With Buckminsterfullerene," Proceedings of the Eighth International Symposium on Cyclodextrins Symposium, Budapest (Hungary): 3-30 to 4-02, 1996, and Journ. Incl. Phenomena and Mol. Recog. In Chem., 25(1-3), 97-102 (1996).

394. M. E. Brewster, W. R. Anderson, T. Loftsson, N. Bodor and E. Pop, "Effect of 2- Hydroxypropyl-β-Cyclodextrin Complexes of the Neurosteroids, Alfaxalone, Pregnanolone And Pregnenolone, On Various Convulsant Stimuli In The Mouse," Proceedings of the 8th International Cyclodextrin Symposium, Budapest (Hungary): 3-30 to 4-02, 1996, Editions de Sante, Paris, accepted for publication (1996).

395. M. E. Brewster, W. R. Anderson, A. Webb, N. Bodor and E. Pop, "Anesthetic Activity and Pharmacokinetics of the Neurosteroid Alfaxalone Formulated in 2-Hydroxypropyl-β- Cyclodextrin in the Rat," Proceedings of the 8th International Cyclodextrin Symposium, Budapest (Hungary): 3-30 to 4-02, 1996, Editions de Sante, Paris, accepted for publication (1996).

396. M. E. Brewster, J. Howes, W. Griffith, N. Garty, N. Bodor, W. R. Anderson and E. Pop, "Intravenous and Buccal 2-Hydroxypropyl-β-Cyclodextrin Formulations of E2-CDS - Phase I Clinical Trials," Proceedings of the 8th International Cyclodextrin Symposium, Budapest (Hungary): 3-30 to 4-02, 1996, Editions de Sante, Paris, accepted for publ. (1996).

397. M. Brewster, M. Huang, N. Bodor and E. Pop, "AM1-Based Model System for Estimation of Brain/Blood Concentration Ratios," Int. J. Quantum Chem., 60, 51-63 (1996).

398. M. E. Brewster, T. Murakami, W. R. Anderson, N. Bodor and E. Pop, "Improved Bioavailability of the Brain-Targeting Estrogen, E2-CDS, Through the Use of Carboxymethylethl-β-Cyclodextrin," Proceedings of the 8th International Cyclodextrin Symposium, Budapest (Hungary): 3-30 to 4-02, 1996, Editions de Sante, Paris, (1996).

399. G. Brouillette, M. Kawamura, G. Kumar and N. Bodor, "Soft Drugs 21. Design and Evaluation of Soft Analogs of Propantheline," J. Pharm Sci., 85(6), 619-623 (1996).

400. P. Chikhale, V. Venkatraghavan and N. Bodor, "Improved Delivery Through Biological Membranes LX: Intradermal Targeting of Acyclovir Using Redox-Based Chemical Delivery System," Drug Del., 3, 17-26 (1996).

401. A.Kourounakis, N. Bodor and J. Simpkins, "Synthesis and Evaluation of Brain-Targeted Catechol Derivative as a Potential NGF-Inducer," Int. J. Pharm., 141 239-250 (1996).

402. G. Kumar and N. Bodor, "Soft Anticholinergics," Cur. Med. Chem.., 3, 23-36 (1996).

403. E. Pop, F. Soti, W. Anderson, J. Panetta, K. Estes, N. Bodor and M. Brewster, "Redox Targeting of LY231617, An Antioxidant with Potential Use in the Treatment of Brain Damage," Int. J. Pharm., 140, 33-44 (1996).

404. K. Prokai-Tatrai, L. Prokai and N. Bodor, "Brain-Targeted Delivery of a Leu-Enkephalin Analogue by Retrometabolic Design," J. Med. Chem., 39, 4775-4782(1996).

405. O. Rabbani, K. Panickar, G. Rajakumar, M. King, N. Bodor, E. Meyer and J. Simpkins, "17 β-Estradiol Attentuates Fimbrial Lesion-Induced Decline of ChAT-Immunoreactive Neurons in the Rat Medial Septum," Experimental Neurology, 146, 179-186 (1997).

406. I. Reddy, M. Khan, W. Wu and N. Bodor, "Permeability of a Soft Steroid, Loteprednol Etabonate Through An Excised Rabbit Cornea," J. Ocular Pharmacol. & Ther., 12(2), 159- 167 (1996).

407. M. Saah, W. Wu, K. Eberst, E. Marvanyos and N. Bodor, "Design, Synthesis and Pharmacokinetic Evaluation of a Chemical Delivery System for Drug Targeting to Lung Tissue," J. Pharm. Sci., 85(5), 496-504 (1996).

408. N. Bodor, "Brain Targeting of Drugs and Neuropeptides by Retrometabolic Design Approaches," s.t.p. pharma sciences Editions De Sante, 1, 43-55 (1997).

409. N. Bodor, "Drug Discovery in Universities," Farumashia, 33(10) 1116-118 (1997) (in Japanese).

410. N. Bodor, "Retrometabolic Approaches for Drug Design and Targeting," Die Pharmazie, 52(7), 491-494 (1997).

411. N. Bodor and P. Buchwald, "A Molecular Size Based Approach to Estimate Partition Properties for Organic Solutes," J. Phys. Chem. B, 101, 3404-3412 (1997).

412. N. Bodor and P. Buchwald, "Drug Targeting via Retrometabolic Approaches," Proceedings of the 6th Int'l Symposium on Molecular Aspects of Chemotherapy, Gdansk (Poland): 7/9- 12, 1997; Pharm. and Ther., 76(103), 1-27 (1997).

413. N. Bodor and P. Chen, "Redox Aminoacids Can Serve as Targeting Building Blocks for Peptides," J. Amer. Chem. Soc., submitted for publication (1997).

414. N. Bodor, H. Farag, G. Somogyi, W. Wu, D. Barros and L. Prokai, "Ocular-Specific Delivery of Timolol by Sequential Bioactivation of its Oxime and Methoxime Analogs," J. Ocular Pharmacol. & Ther., 13(5), 389-403 (1997).

415. N. Bodor and M. Huang, "On the Mechanism of the E ↔ Interconversion of β- aminoketoximes," J. Amer. Chem. Soc., submitted for publication (1997).

416. N. Bodor and M. Huang, "Theoretical Study of the Stereoisomers of Tetrahydrocannabinols," Int. J. Quant. Chem., 61, 127-135 (1997).

417. M. Brewster, W. Anderson, D. Meinsma, D. Moreno, A. Webb, L. Pablo, K. Estes, H. Derendorf, N. Bodor, R. Sawchuk, B. Cheung and E. Pop, "Intravenous and Oral Pharmacokinetic Evaluation of a 2-Hydroxypropyl-β-cyclodextrin-Based Formulation of Carbamazepine in the Dog: Comparison with Commercially Available Tablets and Suspensions," J. Pharm. Sci., 86(3), 335-339 (1997).

418. M. Brewster, W. Anderson, A. Webb, L. Pablo, D. Meinsma, D. Moreno, H. Derendorf, N. Bodor and E. Pop, "Evaluation of a Brain-Targeting Zidovudine Chemical Delivery System in Dogs," Antimicrobial Agents and Chemotherapy, 41(1), 122-128 (1997).

419. H. Farag, W. Wu, D. Barros, G. Somogyi, L. Prokai and N. Bodor, "Ocular-Specific Chemical Delivery Systems of Betaxolol for Safe Local Treatment of Glaucoma," Drug Design and Discovery, 15, 117-130 (1997).

420. M. Huang, J. Watts and N. Bodor, "Theoretical Studies of Inclusion Complexes of α- and β- Cyclodextrin with Benzoic Acid and Phenol," Int'l. J. Quant. Chem., for the Proceedings of the 1997 Sanibel Symposium, 65, 1135-1152 (1997).

421. M. Huang, J. Watts and N. Bodor, "Theoretical Studies of Inclusion Complexes of β- Cyclodextrin with Methylated Benzoic Acids," Int. J. Quant. Chem., 64, 711-719 (1997).

422. A. Kourounakis, N. Bodor and J. Simpkins, "Synthesis and Evaluation of Brain-Targeted Chemical Delivery Systems for the Neurotrophomodulator 4-Methylcatechol," J. Pharm. & Pharmacol., 49, 1-9 (1997).

423. L. Prokai, K. Prokai-Tatrai, W. Wu, J. Wu, X. Ouyang, H. Kim, A. Zharikova, J. Simpkins and N. Bodor, "Brain delivery and targeting of thyrotropin-releasing hormone analogs by covalent packaging and sequential metabolism," in Peptides: Chemistry, Structure and

Biology (J. P. Tam and P. T. P. Kauyama, Eds.) Kluwer Academic Publ., Doredrecth, 834- 836 (1997).

424. J. Simpkins, G. Rajakumar, Y. Zhang, C. Simpkins, D. Greenwald, C. Yu, N. Bodor and A. Day, "Estrogens Reduce Mortality and Ischemic Damage Induced by Middle Cerebral Artery Occlusion in the Female Rat," J. Neurosurgery, 87, 724-730 (1997).

425. N. Bodor and P. Buchwald, "All in the Mind," Chemistry in Britain," January, 36-40 (1998).

426. N. Bodor, P. Buchwald and M. Huang, "Computer-Assisted Design of New Drugs Based on Retrometabolic Concepts, Proceedings of the Data Management in Computer-Aided Drug Design Workshop, Ispra (Italy): 1/20 to 22, 1997, SAR and QSAR in Envir. Research, 8, 41- 92 (1998).

427. N. Bodor, P. Chen, W-M. Wu and L. Prokai, “Brain Targeting of Basic Amino Acids and Their Redox Analogs Containing Peptides,” Proceedings of the 2nd World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Paris, France, May 25- 28 (1998).

428. N. Bodor, K. Prokai-Tatrai, E. Koltai and L. Prokai, "Preparation of O-(3,3,8,10,10- pentamethyl-1,2-dithia-5,8-diaza-cyclodecan-5-yl)ethyl-O-pivaloyloxymethylene-P-phenyl phosphonate,’ OPPI Briefs, 30(4), 485-488, (1998).

429. P. Buchwald and N. Bodor, "Molecular Size-Based Model to Describe Simple Organic Liquids," J. Phys. Chem., 102(29), 5715-5726 (1998).

430. P. Buchwald and N. Bodor, "Octanol-Water Partition Coefficient for Non-Zwitterionic Peptides: Predictive Power of a Molecular Size Based Model," Proteins Structure, Function, and Genetics, 30. 86-99 (1998).

431. P. Buchwald and N. Bodor, "Octanol-water partition: Searching for predictive models," Curr. Med. Chem., 5(5), 353-380 (1998).

432. L. Buris, Jr., N. Bodor and L. Buris, "Loteprednol etabonate, a new soft steroid is effective in a rabbit acute experimental model for arthritis," Die Pharmazie, 53(12), 1-6 (1998).

433. P. Chen, N. Bodor, W. Wu and L. Prokai, "Strategies to Target Kyotorphin Analogs to the Brain," J. Med. Chem., 41(20), 3773-3781 (1998).

434. A. Juhasz, F. Huang, F. Ji, P. Buchwald, W. M. Wu and N. Bodor, "Design and Evaluation of New Soft Anticholinergic Agents," Drug Devel. Res., 43, 117-127 (1998).

435. L. Prokai, X. Ouyang, K. Prokai-Tatrai, J. Simpkins, N. Bodor, "Synthesis and behavioral evaluation of a chemical brain-targeting system for a thyrotropin-releasing hormone analogue," Eur. J. Med. Chem., 33, 879-886 (1998).

436. G. Somogyi, P. Buchwald, D. Nomi, L. Prokai and N. Bodor, "Targeted Drug Delivery to the Brain via Phosphonate Derivatives II. Anionic Chemical Delivery System for Zidovudine (AZT)," Int. J. Pharm., 166, 27-35 (1998).

437. G. Somogyi, S. Nishitani, D. Nomi, P. Buchwald, L. Prokai and N. Bodor, "Targeted Drug Delivery to the Brain via Phosphonate Derivatives I. Design, Synthesis, and Evaluation of an Anionic Chemical Delivery System for Testosterone," Int. J. Pharm., 166, 15-26, (1998)

438. N. Bodor, “Recent Advances in Retrometabolic Design Approaches,” Proceedings of the Conference on Challenges for Drug Delivery and Pharmaceutical Technology, in honor of Professor Tsuneji Nagai’s 65th Birthday, Waseda University, Tokyo, Japan, June 9-11, 1998, special issue, Journal of Controlled Release, 62, 209-222 (1999).

439. N. Bodor, “Retrometabolic Concepts for the Design of Safer Drugs,” Proceedings of the 80th Anniversary of the Debrecen University Medical School, Debrecen, Hungary, October 17- 25, 1998, G. Barabas, L. Fesus, and M. Gyorffi, Eds., Trends in Biomedical Sciences at the turn of the Millenium, Hungary, 3-26 (1999).

440. N. Bodor and P. Buchwald, "Recent Advances in the Brain Targeting of Neuropharmaceuticals by Chemical Delivery Systems," chapter in Adv. Drug Del. Reviews, 36, 229-254 (1999).

441. N. Bodor and P. Buchwald, "Retrometabolic Drug Design: Principles, Examples, and Computational Techniques, Magyar Kemiai Folyoirat, 105, 337-362 (1999).

442. N. Bodor and P. Buchwald, “Soft Drugs: Designing Safer Drugs by Simplifying Drug Metabolism,” Chapter in IUPAC Monograph: Drug Metabolism Databases and High- Throughput Testing During Drug Design and Development,” 223-235 (1999).

443. N. Bodor, P. Buchwald and M. Huang, “The role of computational techniques in retrometabolic drug design strategies,” chapter 15 in Theoretical and Computational Chemistry, Computational Molecular Biology, J. Leszcynski, Ed., Elsevier Science B.V., Vol. 8, 569-618 (1999).

444. N. Bodor and J. Kaminski, "Chemical Approaches to Drug Delivery," Encyclopedia of Controlled Drug Delivery, 1, 285-298 (1999).

445. N. Bodor, W-M. Wu and J. Wu, “The Effect of 2-Hydroxypropyl-ß-Cyclodextrin on the Solubility, Stability and Brain Targeting of Chemical Delivery Systems for Neuropeptides,”

Proceedings of the 9th International Symposium on Cyclodextrins, Santiago de Compostela, Spain: 05/31-06/03/98, Kluwer Academic Publishers, 251-256 (1999).

446. P. Buchwald and N. Bodor, "Quantitative Structure-Metabolism Relationships: Steric and Other Effects in the Enzymatic Hydrolysis of Non-Congener Carboxylic Esters," Journal of Medicinal Chemistry, 42, 5160-5168 (1999).

447. V. Goskonda, M. Khan, N. Bodor and I. Reddy, "Chemical Delivery Systems: Evaluation of Physicochemical Properties and Enzymatic Stability of Phenylephrone Derivatives," Prod. Dev. Tech., 4(2), 189-198 (1999).

448. A. Juhasz, N. Bodor, P. Milner and P. Druzgala, "The Use of Esterases in the Design of Safer Drugs: Amiodarone Analogs with Rapid Onset and Fast Offset of Antiarrhythmic Activity, J. Med. Chem., submitted for publication (1999).

449. R.J. Little, N. Bodor and T. Loftsson, "Soft Drugs Based on Hydrocortisone. The Inactive Metabolite Approach and its Application to Steroidal Antiinflammatory Agents," Pharmaceutical Research, 16(6), 961-967 (1999).

450. K. Prokai-Tatrai, V. Dhawan, L. Szabo and N. Bodor, “Synthesis of Novel Derivatives of S- Adenosylmethionine as Potential Prodrugs,” J. Org. Chem., submitted for publication (1999).

451. L. Prokai, K. Prokai-Tatrai, X. Ouyang, H. Kim, W. Wu, A. Zharikova and N. Bodor, “Metabolism-Based Brain-Targeting System for a Thyrotropin-Releasing Hormone Analogue,” J. Med. Chem., 42(22), 4563-4571 (1999).

452. N. Bodor, “Recent advances in retrometabolic drug design and targeting approaches,” Die Pharmazie, 55(3), 163-166 (2000).

453. N. Bodor and P. Buchwald, "Extended Covalent Polymeric Form of Carbon Dioxide: A Possible Structure," Chemical Physics Letters, 319, 645-649 (2000).

454. N. Bodor and P. Buchwald, "Soft Drug Design: General Principles and Recent Applications," Medicinal Research Reviews, 20, 58-101 (2000).

455. N. Bodor, J. Drustrup and W.-M. Wu, “Effect of cyclodextrins on the solubility and stability of a novel soft corticosteroid, loteprednol etabonate,” Die Pharmazie, 55(3), (2000).

456. N. Bodor, S. C. Moon and L. Bruno-Blanch, “Synthesis and pharmacological evaluation of prodrugs of valproic acid,” Die Pharmazie, 55(3), 184-186 (2000).

457. A. Buchwald, C. E. Browne, W.-M. Wu, F. Ji and N. Bodor, “Soft cannabinoid analogues as potential anti-glaucoma agents,” Die Pharmazie, 55(3), 196-201, (2000).

458. P. Buchwald and N. Bodor, “Structure-based estimation of enzymatic hydrolysis rates and its application in computer-aided retrometabolic drug design,” Die Pharmazie, 55(3), 210-217 (2000).

459. P. Buchwald and N. Bodor, “Simple Model for Non-associative Organic Liquids and Water,” J. Amer. Chem. Soc., 122(43), 10671-10679, (2000).

460. F. Ji, F. Huang, A. Juhász, W. Wu and N. Bodor, “Design, synthesis, and pharmacological evaluation of soft glycopyrrolate and its analog,” Die Pharmazie, 55(3), 187-191 (2000).

461. S-K Hwang, A. Juhasz, S-H Yoon and N. Bodor, "Soft Drugs XXII; Design, Synthesis and Evaulation of Soft Bufuralol Analogues," Journal of Medicinal Chemistry, 43(8), 1525-1532 (2000).

462. A Juhász and N. Bodor, “Cardiovascular studies on different classes of soft drugs,” Die Pharmazie, 55(3), 228-238 (2000).

463. L. Prokai, K. Prokai-Tatrai and N. Bodor, “Targeting Drugs to the Brain by Chemical Delivery Systems,” Medicinal Research Reviews, 20(5), 367-416 (2000).

464. S-H Yoon, J. Wu, W-M Wu, L. Prokai and N. Bodor, "Brain-Targeted Chemical Delivery of [Leu2, Pip3]-TRH: Synthesis and Biological Evaluation", Bioorganic & Medicinal Chemistry, 8, 1059-1063 (2000).

465. N. Bodor, “Retrometabolic Drug Design – Novel Aspects, Future Directions,” Die Pharmazie, 56, Suppl. 1, S67-S74 (2001).

466. N. Bodor and P. Buchwald, “Design and Development of a Soft Corticosteroid, Loteprednol Etabonate,” chapter in Inhaled Steroids in Asthma: Optimizing Effects in the Airways, Eds. R. Scheimer, P. O’Byrne, S. Szefler and R. Brattsand; Marcel Dekker, Inc., 541-564 (2001).

467. N. Bodor and P. Buchwald, “Drug Targeting by Retrometabolic Design: Soft Drugs and Chemical Delivery Systems,” Journal of Receptor and Signal Transduction Research, 21 (2- 3), 287-310 (2001).

468. N. Bodor and P. Buchwald, “Drug Targeting by Retrometabolic Design: Soft Drugs and Chemical Delivery Systems,” chapter in book, Drug Targeting Technology: Physical · Chemical · Biological Methods, Marcel Dekker, Inc., 115, 163-187 (2001).

469. Bodor, H. Farag, and P. Polgar, "A tryptamine analog with high affinity to the heart tissues is a potential antiarrhythmic agent," Journal of Pharmacy and Pharmacology, 53(6), 889-894 (2001).

470. P. Buchwald and N. Bodor, “A Simple, Predictive, Structure-Based Skin Permeability Model,” J. Pharm. & Pharmacol., 53(8), 1087-1098 (2001).

471. F. Huang, P. Buchwald, C. E. Browne, H. H. Farag, W.-M. Wu, F. Ji, G. Hochhaus and N. Bodor, “Receptor Binding Studies of Soft Anticholinergic Agents,” AAPS PharmSci., 3(4), 1-13 (2001).

472. Reddy, S. R. Vaithiyalingam, M. Khan and N. Bodor, "Design, In Vitro Stability and Ocular Hypotensive Activity of t-Butalone Chemical Delivery Systems," J. Pharm. Sci., 90(8), 1026-1033 (2001).

473. N. Bodor and P. Buchwald, “Designing Safer (Soft) Drugs by Avoiding the Formation of Toxic and Oxidative Metabolites,” chapter 32 in book, Oxidative Stress Biomarkers and Antioxidant Protocols, Humana Press, Ed. D. Armstrong, 186, 301-312 (2002).

474. N. Bodor and P. Buchwald, “Barriers to Remember: Brain-Targeting Chemical Delivery Systems and Alzheimer’s Disease,” Drug Discovery Today, 7(14), 766-774 (2002).

475. N. Bodor and P. Buchwald, “Theoretical Insights into the Formation, Structure, and Energetics of Some Cyclodextrin Complexes,” Journal of Inclusion Phenomena and Macrocyclic Chemistry; proceedings of the 11th International Cyclodextrin Symposium, May 5-8, 2002, Reykjavik, Iceland, 44(1-4), 9-14 (2002).

476. N. Bodor, H. H. Farag, M. D. C. Barros, W.-M. Wu and P. Buchwald, “In Vitro and In Vivo Evaluations of Dihydroquinoline- and Dihydroisoquinoline-Based Targetor Moieties for Brain-Specific Chemical Delivery Systems,” Journal of Drug Targeting, 10(1), 63-71 (2002).

477. Buchwald, H. Derendorf, F. Ji, N. Nelamangala, W.-M. Wu and N. Bodor, “Soft cannabinoid analogues as potential anti-glaucoma agents,” Proceedings of the 3rd Retrometabolism Based Drug Design and Targeting Conference, held May 13-16, 2001, Amelia Island, Florida; Die Pharmazie, 57, 108-114 (2002).

478. P. Buchwald and N. Bodor, “Physicochemical Aspects of the Enzymatic Hydrolysis of Carboxylic Esters,” Proceedings of the 3rd Retrometabolism Based Drug Design and Targeting Conference, held May 13-16, 2001, Amelia Island, Florida; Die Pharmazie, 57, 87-93 (2002).

479. P. Buchwald and N. Bodor, “Computer-aided drug design: the role of quantitative structure- property, structure-activity, and structure-metabolism relationships, (QSPR, QSAR, QSMR),” Drugs of the Future, 27(6), 577-588 (2002).

480. F. Huang, W.-M. Wu, F. Ji, A. Juhász and N. Bodor, “Design, pharmacokinetic, and pharmacodyamic evaluation of soft anticholinergics based on tropyl α- phenylcyclopentylacetate,” Proceedings of the 3rd Retrometabolism Based Drug Design and Targeting Conference, held May 13-16, 2001, Amelia Island, Florida; Die Pharmazie, 57, 115-121 (2002).

481. F. Ji, W.-M. Wu and N. Bodor, “Studies on a soft glycopyrrolate analog, SG-1,” Proceedings of the 3rd Retrometabolism Based Drug Design and Targeting Conference, held May 13-16, 2001, Amelia Island, Florida; Die Pharmazie, 57, 138-141 (2002).

482. A. Miklós, Z. Magyar, É. Kiss, I. Novák, M. Grósz, M. Nyitray, I. Dereszlay, E. Czégeni, A. Druga, J. Howes and N. Bodor, “28-Day oral toxicity study with soft corticosteroid BNP- 166 in rats and dogs, followed by a 14-day recovery period,” Proceedings of the 3rd Retrometabolism Based Drug Design and Targeting Conference, held May 13-16, 2001, Amelia Island, Florida; Die Pharmazie, 57, 142-146 (2002).

483. G. Somogyi, P. Buchwald and N. Bodor, “Targeted drug delivery to the central nervous system via phosphonate derivatives (anionic delivery system for testosterone,” Proceedings of the 3rd Retrometabolism Based Drug Design and Targeting Conference, held May 13-16, 2001, Amelia Island, Florida; Die Pharmazie, 57, 135-137 (2002).

484. W.-M. Wu, J. Wu and N. Bodor, “Effect of 2-hydroxypropyl-ß-cyclodextrin on the solubility, stability, and pharmacological activity of the chemical delivery system of TRH analogs,” Proceedings of the 3rd Retrometabolism Based Drug Design and Targeting Conference, held May 13-16, 2001, Amelia Island, Florida; Die Pharmazie, 57, 130-134 (2002).

485. J. Wu, S.-H. Yoon, W.-M. Wu and N. Bodor, “Synthesis and Biological Evaluations of Brain Targeted Chemical Delivery Systems of [Nva2]-TRH,” Journal of Pharmacy and Pharmacology, 54(7), 945-950 (2002).

486. N. Bodor and P. Buchwald, “Retrometabolism-Based Drug Design and Targeting,” chapter in book, Burger’s Medicinal Chemistry, 6th Edition, John Wiley & Sons, Ed. D. Abraham, 2(15), 533-608 (2003).

487. N. Bodor and P. Buchwald, “Brain-Targeted Drug Delivery: Experiences to Date,” Am. J. Drug Deliv., 1(1), 13-26 (2003).

488. F. Huang, C. E. Browne, W.-M. Wu, At. Juhász, F. Ji and N. Bodor, “Design Pharmacokinetic, and Pharmacodynamic Evaluation of a New Class of Soft Anticholinergics,” Pharmaceutical Reseach, 20(10), 1681-1689 (2003).

489. A. Juhász, J. Howes, L. Mantelle, A. Halabi and N. Bodor, “Evaluation of a Buccal Delivery Formulation of E2CDS in Postmenopausal Women,” Proceedings of the North American Menopause Society 14th Annual Meeting, Sept. 17-19, 2003 (poster presentation).

490. I. Kurucz, S. Tóth, K. Németh, K. Török, V. Csillik-Perczel, Á. Pataki, C. Salamon, Z. Nagy, J. Székely, K. Horváth and N. Bodor, “Potency and specificity of the pharmacological action of a new, anti-asthmatic, topically administered soft steroid, etiprednol dicloacetate (BNP- 166), J. Pharm. & Exp. Ther., 307(1), 83-92 (2003). Also published online July 31, 2003 as DOI:10.1124/jpet.103.053652.

491. M. Tapfer, L. Sebestyen, I. Kurucz, K. Horváth, I. Szelenyi and N. Bodor, “New evidence for the selective, long-lasting central effects of the brain-targeted estradiol, Estredox,” Pharmacol. Biochem. Behav., in press (2003).

492. N. Bodor and P. Buchwald, “Corticosteroid Design for the Treatment of Asthma: Structural Insights and the Therapeutic Potential of Soft Corticosteroids,” Curr. Pharm. Design, submitted for publication (2004).

493. N. Bodor and P. Buchwald, “Designing Safer (Soft) Drugs by Avoiding the Formation of Toxic and Oxidative Metabolites,” Molecular Biotechnology, 26(2), 123-132 (2004).

494. M. Brewster, T. Loftsson and N. Bodor, “Applications of chemically-modified cyclodextrins: use of hydroxypropyl-β-cyclodextrin as an enabling excipient for brain targeting, redox-based derivatives of estradiol – A review of preclinical and clinical findings,” J. Drug Del. Sci. Tech., 14(1), 21-34 (2004).

495. P. Buchwald and N. Bodor, “Soft Glucocorticoid Design: Strucutural Elements and Physicochemical Parameters Determining Receptor-Binding Affinity,” Proceedings of the 4th Retrometabolism Based Drug Design and Targeting Conference, held May 11-14, 2003, Palm Coast, Florida; Die Pharmazie, 5, 396-404 (2004).

496. P. Buchwald, B. Einstein and N. Bodor, “QSAR Study of 2,3-Benzodiazepin-4(thi)one- and 1,2-Phthalazine-Related Negative Allosteric Modulators of the AMPA Receptor: A Structural Descriptors-Based Reassessment,” QSAR & Combinatorial Science, accepted for publication (2004).

497. P. Buchwald, A. Juhász, C. Bell, M. Pátfalusi, J. Howes and N. Bodor, “Unified Phamacogenomics-Based Parent-Metabolite Pharmacokinetic Model Incorporating

Acetylation Polymorphism for Talampanel in Humans,” Drug Metabolism and Disposition, submitted for publication (2004).

498. Á. Csanádi Gy. Horváth, t. Szekeres, T. Haskó, L. ila, J. Ivanics, M. Patthy, J. Salát, G. Seres, I. Pallagi, G. Tóth, F. Szederkényi, A. Kónya, A. Tegdes, N. Bodor and Z. Zubovics, “Etiprednol Dicloacetate, a New Soft Glucocorticoid Drug Candidate. Development of Chemistry,” Proceedings of the 4th Retrometabolism Based Drug Design and Targeting Conference, held May 11-14, 2003, Palm Coast, Florida; Die Pharmazie, 5, 349-359 (2004).

499. A. Juhász, P. Buchwald, C. Camarasu, A. Csárdi, M. Pátfalusi, P. Kovács and N. Bodor, “The Effects of a High-Calorie, High-Fat Diet on the Oral Bioavailability of Talampanel among Healthy Volunteers from Different N-Acetylation Polymorphism Groups Determined by Genotyping, J. Clin. Pharm., submitted for publication (2004).

500. I. Kurucz, K. Németh, S. Mészáros, K. Török, Z. Nagy, Z. Zubovics, K. Horváth and N. Bodor, “Anti-inflammatory Effect and Soft Properties of Etiprednol Dicloacetate (BNP- 166), a New, Anti-Asthmatic Steroid,” Proceedings of the 4th Retrometabolism Based Drug Design and Targeting Conference, held May 11-14, 2003, Palm Coast, Florida; Die Pharmazie, 5, 412 - 416 (2004).

501. M. Patthy, G. Seres, Á. Csanádi, T. Szekeres, Z. Zubovics and N. Bodor, “HPLC Separation of Related Impurities in Etiprednol Dicloacetate, a Novel Soft Corticosteroid,” Proceedings of the 4th Retrometabolism Based Drug Design and Targeting Conference, held May 11-14, 2003, Palm Coast, Florida; Die Pharmazie, 5, 382-386 (2004).

502. G. Somogyi, P. Buchwald and N. Bodor, “Metabolic Properties of Phosphonate Esters,” Proceedings of the 4th Retrometabolism Based Drug Design and Targeting Conference, held May 11-14, 2003, Palm Coast, Florida; Die Pharmazie, 5, 378-381 (2004).

503. N. Bodor and P. Buchwald, “Targeting of Neuropharmaceuticals by Chemical Delivery Systems,” chapter in book, Blood-Brain Interfaces – From Ontogeny to Artificial Barriers, Dermietzel, Spray, Nedergaard, Eds., Wiley Press, submitted for publication (2005).

Last Updated: February 2, 2005 INVITED LECTURES GIVEN BY NICHOLAS BODOR

March, 1978- November, 1999

Location Date Institution

Lake Ozark, MO 3/78 11th Higuchi Research Seminar

JAPAN:

Osaka 5/78 Otsuka Pharmaceutical Co. Osaka 5/78 Kanebo, Ltd. Tokyo 5/78 Sankyo

Aberdeen Proving 6/78 Edgewood Arsenal Ground, MD

Chicago, IL 11/78 Abbott Laboratories

Kalamazoo, MI 1/79 Upjohn Comnpany

Lake Ozark, MO 3/79 Ayerst Laboratory

Honolulu, HI 4/1-6/79 ACS/CSJ Symposium Computer Assisted Drug Design

Palo Alto, Ca 4/79 Syntex Research

Raleigh, NC 6/79 Decontamination of Chemical Agents ARO Special Meeting

Philadelphia, PA 11/79 McNeil Laboratories

ENGLAND:

London 11/79 Chemical Society- Royal Society London 11/79 University of London Portsmouth 11/79 American Cyanamid Birmingham 11/79 University of Birmingham

Bloomfield, NJ 2/80 Schering-Plough Curriculum Vitae--Presentations Nicholas Bodor

Lake, Ozark, MO 3/80 13th Higuchi Research Seminar

Skokie, IL 4/80 G.D. Searle Skokie, IL 4/80 APhA National Meeting

Las Vegas, NV 8/24-29/80 ACS Symposium, "Soft Drugs: Strategies for Design of Safer Drugs"

8/80 Gordon Conference Research Conference on Medicinal Chemistry

Reston, VA 11/3-15/80 ARO Conference on Defense Against Chemical Agents, "Acceleration of Deactivation of Chemical Agents"

Ann Arbor, MI 12/8/80 University of Michigan, "The Soft Drug Approach: Strategies for the Design of Safer Drugs"

12/9/80 Warner Lambert, "The Soft Drug Approach: Strategies for the Design of Safer Drugs"

Washington, DC 2/23/81 National Institute for Aging, "Soft Drugs"

Lake Ozark, MO 3/15-18/81 14th Higuchi Research Seminar

Atlanta, GA 4/12-17/81 FASEB Symposium on Drug Carrier Systems, "The Prodrug Approach to Controlled Delivery" Curriculum Vitae--Presentations Nicholas Bodor

New London, NH 8/3-7/81 Gordon Research Conference on Medicinal Chemistry

Noordwijkerhout, 8/25-28/81 IUPAC-IUPHAR THE NETHERLANDS Symposium, "Strategy in Drug Research"

Indianapolis, IN 10/20/21/81 Lilly Research Company

Montpellier, FRANCE 11/27-28/81 Clin Midy Research Center Symposium, "Drug Metabolism and Drug Design: Quo Vadis?"

JAPAN:

Osaka 12/6-14/81 Otsuka Pharmaceutical Co. Kyoto 12/7/81 Kyoto University

Painesville, OH 1/10-11/82 Diamond Shamrock

Clifton, NJ 1/25/82 American Cyanamid Company

Hillside, NJ 2/15-16/82 Bristol Myers

Boston, MA 2/22/82 Gillette Company

Lake Ozark, MO 3/15-17/82 15th Higuchi Research Seminar

Painesville, Oh 3/29/82 Diamond Shamrock

Groton, Ct 3/31/82 Pfizer Company

Curriculum Vitae--Presentations Nicholas Bodor

Aberdeen Proving 4/1/82 Edgewood Arsenal Ground, MD

Austin, TX 5/6/82 University of Texas

College Station, 5/7/82 Texas A&M University TX

Chicago, IL 5/25/82 Abbott Laboratories, "Brain-Specific Delivery of Drugs"

JAPAN:

Osaka 12/82 Fujisawa Pharmaceutical Co. Hiroshima 12/82 Umezawa Research Institute, "Brain- Specific Delivery of Drugs" Kyoto 12/82 University of Kyoto, "Soft Drugs"

Lake Ozark, Mo 3/13/-16/83 16th Higuchi Research Seminar

Skokie, IL 4/25/83 G.D. Searle

San Francisco, CA 5/6/83 University of California at San Francisco

Somerville, NJ 9/29/83 Hoechst-Roussel

Gainesville, FL 10/19/83 University of Florida Frontiers of Science, "Strategies to Design Safe Drugs"

Curriculum Vitae--Presentations Nicholas Bodor

JAPAN: 10/25-11/15/83

Tokyo Sankyo, Ltd. Tokyo Hoshi University, Special Lecture Tokyo Snow Brand Milk Products Tokyo Toyo Jozo Co., Ltd. Osaka Takeda Chemical Industries, Ltd. Osaka Fujisawa Pharmaceutical Co. Osaka Tanabe Co., Ltd. Osaka Sumitomo Company Osaka Otsuka Pharmaceutical Co. Osaka Yoshitomi Company Hiroshima Hiroshima University, Key Lecture at Drug Design and Metabolism Symposium Kyoto Ono Pharmaceuticals Kyoto Kyoto University-- Japanese Pharmaceutical Association Takata Wakunaga Pharmaceutical Co.

Boston, MA 12/7/83 New England Nuclear

Detroit, MI 12/8/83 Warner Lambert

Gainesville, FL 12/14/83 University of Florida Endocrinology Seminar

Chicago, Il 12/19/83 Smith Labs

Assiut, EGYPT 1/84 University of Assiut, Lecture Series Curriculum Vitae--Presentations Nicholas Bodor

Milan, ITALY 1/84 Recordati Pharmaceutica e Chimica

Basel, SWITZERLAND 1/84 Sandoz, Inc.

INDIA:

Bombay 1/28/84 Bombay College of Pharmacy, International Symposium Celebrating 25th Anniversary New Delhi 2/1/84 Indian Pharmaceutical Association Satellite Seminar on Advances in Drug Delivery Systems

JAPAN:

Osaka 2/84 Ono Pharmaceuticals Osaka 2/84 Yoshitomi Company Osaka 2/84 Fujisawa Pharmaceutical Co.

Lake Ozark, Mo 3/11-14/84 17th Higuchi Research Seminar

Arlington, VA 4/19/84 NIH Special Study Section on "Boronate, Redox and Related Compounds as Vital Reagents"

Boston, MA 5/15/84 American Chemical Society, NE Section, Invited Lecture

Miami, FL 7/26/84 Key Pharmaceuticals Curriculum Vitae--Presentations Nicholas Bodor

New London, NH 7/30-8/3/84 Gordon Conference on Medicinal Chemistry

Philadelphia, PA 8/26-31/84 American Chemical Society Symposium on Drug Design and Discovery

Gainesville, FL 9/27/84 University of Florida Department of Chemistry

Philadelphia, PA 10/28-31/84 American Pharmaceutical Association Academy of Pharmaceutical Sciences Symposium on Theory and Application of Bioreversible Carriers to Drug Design

West Chester, PA 11/1/84 SmithKline and Beckman Corporation

Gainesville, FL 11/9/84 Engineering Advisory Council

Austin, TX 2/21-22/85 University of Texas

Lake Ozark, Mo 3/10-13/85 18th Higuchi Research Seminar

Curriculum Vitae--Presentations Nicholas Bodor

JAPAN:

Tokyo 3/18/85 Tokyo University- Pharmaceutical Society of Japan (Divisional) Tsukuba 3/19/85 Eisai Company Osaka 3/20/85 Takeda Pharmaceutical Co. Osaka 3/21/85 Sumitomo Pharmaceutical Co.

Hiroshima 3/22/85 Hiroshima University- Pharmaceutical Society of Japan (Divisional) Osaka 3/23/85 Ono Pharmaceuticals Tokushima 3/25/85 Otsuka Pharmaceutical Co. Kyoto 3/26/85 Biwako Research Institute Osaka 3/27/85 Nihon Medi-Physics

Anaheim, CA 4/21-25/85 FASEB

Cincinnati, OH 5/7/85 Proctor & Gamble

Raleigh-Durham, NC 5/8/85 Burroughs-Wellcome

Magnolia, AR 5/30/85 Medicinal Chemistry Symposium

Budapest, HUNGARY 6/10/85 National Academy of Science

Milan, ITALY 6/20/85 Recordati Industria Chimica e Farmaceutica S.P.A.

Geneva, SWITZERLAND 6/24/85 Arcopharma

Curriculum Vitae--Presentations Nicholas Bodor

London, ENGLAND 7/4/85 The Institute of Cancer Research and London University College Hospital

Plymouth, NH 7/22-25/85 Gordon Conference on Drug Metabolism

Philadelphia, PA 9/16/85 McNeil Pharmaceutical Co.

Kingsport, TN 9/17/85 Eastman Chemical Co.

Belfast, IRELAND 9/25/85 Queen's University of Belfast, Symposium on Prodrugs, Biochemical Society

Reykjavik, ICELAND 9/27/85 University of Iceland

Copenhagen, DENMARK 9/30/85 Lunbeck A/C

Helsingborg, SWEDEN 10/1/85 Leo Pharmaceuticals

London, ENGLAND 10/3/85 University College Hospital

Kalamazoo, MI 11/7/85 Upjohn Company

Rochester, NY 12/3/85 Eastman Kodak Company

Lake Ozark, MO 3/9-12/86 19th Higuch Research Seminar

Tarrytown, NY 4/4/86 ACS Nichols Distinguished Symposium

Edgewood, MD 5/19/86 Edgewood Arsenal Conference Curriculum Vitae--Presentations Nicholas Bodor

Baltimore, MD 5/20/86 Nova Pharmaceutical Co.

Chapel Hill, NC 6/15-19/86 ACS Medicinal Chemistry Symposium

Budapest, HUNGARY 7/29-8/13/86 Conference on the Role of Hungarians in Science and Technology in the World; National Academy of Science of Hungary; Central Research Institute for Drug Research;

Budapest, Hungary Chinoin Pharmaceutical Co.

Castres Cedex, FRANCE 9/12/86 Pierre Fabre Research Center

West Berlin, GERMANY 9/14-18/86 IXth International Symposium on Medicinal Chemistry

Helsingborg, SWEDEN 9/19/86 Leo Pharmaceutical Co.

Curriculum Vitae--Presentations Nicholas Bodor

JAPAN:

Tokushima 9/29-30/86 Otsuka Research Institute Hiroshima 10/1/86 Hiroshima University Osaka 10/2/86 Takeda Chemical Industries 10/3/86 Sumitomo Pharmaceutical Co. Kyoto 10/4/86 Kyoto University Tokyo 10/6/86 Hoshi University and Kanto Division of Japanese Pharmaceutical Society 10/7/86 Tokyo University 10/7/86 Snow Brand Milk Industries Tsukuba 10/8/86 Eisai Company 10/8/86 Tsukuba Research Institute Osaka 10/9/86 Fujisawa Pharmaceutical Co.

Osaka 10/10/86 Ono Pharmaceutical Co.

Washington, DC 11/2-6/86 American Association Pharmaceutical Scientists

Edgewood, MD 11/18-21/86 Edgewood Arsenal Conference

New York, NY 1/12-015/87 New York Academy of Sciences

Gainesville, FL 2/10/87 Sigma Xi, "Concepts to Design Safer Drugs"

Curriculum Vitae--Presentations Nicholas Bodor

Lake Ozark, MO 3/14-18/87 20th Higuchi Research Seminar

Washington, DC 3/30-4/3/87 FASEB

Milan, ITALY 4/2/87 Recordati Industria Chimica e Farmaceutica S.P.A.

Paris, FRANCE 4/3/87 Delagrange, Inc.

Budapest, HUNGARY 4/3-13/87 Institute for Drug Research and Hungarian Academy of Sciences

Bloomfield, NJ 4/20-21/87 Schering Corporation

Frankfurt, GERMANY 5/20-23/87 Hoechst AG and Cassella Riedel Pharma GmbH

Boston, MA 6/4-7/87 American Association of Pharmaceutical Scientists

Madison, NJ 6/7-12/87 Residential School in Medicinal Chemistry of Drew University

Washington, DC 6/23-25/87 NIH Special Study Section

New York, NY 7/29/87 Pfizer

New London, NH 8/3-7/87 Gordon Conference on Medicinal Chemistry

Curriculum Vitae--Presentations Nicholas Bodor

JAPAN:

Takasaki 9/21/87 Upjohn Tokyo 9/22/87 Eisai Osaka 9/24/87 Takeda Osaka 9/25/87 Ono Hiroshima 9/26/87 Hiroshima University Osaka 9/28/87 Osaka University Tokushima 9/29/87 Otsuka

EUROPE:

Budapest, Hungary 10/17/87 Chinoin Munich, Germany 10/22/87 Cyanamid Frankfurt, Germany 10/22/87 Hoechst Frankfurt, Germany 10/23/87 Merck London, England 10/26/87 May & Baker

Edgewood, MD 11/17-20/87 1987 Scientific Conference on Chemical Defense Research

Honolulu, HI 12/2-7/87 JUC PHARM SCI '87

Raleigh, NC 12/10/87 Burroughs-Wellcome and Glaxco

Beaverton, Or 12/17/87 Tektronix

Chicago, IL 2/3-4/88 Hayes & Griffith

New York, NY 2/7-9/88 Pfizer

Austin, TX 2/25-27/88 Dewar Symposium

Lake Ozark, MO 3/12-16/88 Higuchi Research Seminar

Lexington, KY 3/16-18/88 University of Kentucky

Curriculum Vitae--Presentations Nicholas Bodor

CALIFORNIA:

Palo Alto 4/26/88 Syntex Palo Alto 4/27/88 Alza San Francisco 4/28/88 Genentech

Gainesville, FL 5/6/88 College of Pharmacy Dev. Adv. Board ISRAEL:

Jerusalem 5/29-6/4/88 International Conference on Pharmaceutical Science, "Structure-

Pharmacokinetic Relationships"

Philadelphia, PA 6/22/88 HGP, Inc.

Newark, NJ 7/14/88 Johnson & Johnson

HUNGARY:

Budapest 8/12-19/88 Xth International Symp. on Medicinal Chemistry

Debrecen 8/19-26/88

JAPAN:

Tokyo 10/7-13/88

Tokushima 10/14/88

INDIA:

Newark, NJ 10/24-25/88 Johnson & Johnson

Orlando, FL 10/30-11/3/88 AAPS

Curriculum Vitae--Presentations Nicholas Bodor

Miami, FL 1/27/89 Schering-Plough Corporation

Lake Ozark, MO 3/12-15/89 22nd Higuchi Research Seminar

Anaheim, CA 4/8-11/89 APhA Annual Meeting

GREECE:

Thessaloniki 5/11-16/89 Aristotelian University Postgraduate Seminar on Medicinal Chemistry

JAPAN:

Osaka 5/29-5/30/89 Ono Tokushima 5/31-6/1/89 Otsuka Pharmaceutical Co., Ltd. Tokyo 6/2/89 Upjohn

Curriculum Vitae--Presentations Nicholas Bodor

INVITED LECTURES GIVEN BY NICHOLAS BODOR

July 1, 1989-Present

Location Date Conference or Institution Title

HUNGARY:

Budapest 8/12-19/89 Xth International Symposium on Medicinal Chemistry

Budapest 8/21-25/89 The Role of Hungarians in the "Recent Advances in the Scientific & Technological Design of Safer Drugs" Progress of the World

Bethesda, 9/14-15/89 APhA End-of-Summer "Chemically Designed MD Symposium Targeted Drug Delivery System"

Morgantown, 9/20-21/89 Department of Chemistry "Site-Specific Chemical WV Symposium Delivery Systems"

Atlanta, 10/22-26/89 American Association of "Concepts in the Design of GA Pharmaceutical Scientists Safer Drugs"

Phoenix, 11/3-7/89 Preuss Foundation Seminar "Role of the BBB in the AZ Therapy of Brain Tumors"

JAPAN:

Kyoto 11/23/89 ONO Pharmaceutical Co., Ltd. "Site-Specific Drug Delivery"

Osaka 11/24/89 Otsuka Pharmaceutical Co., Ltd. "Soft Drugs"

Tokyo 11/27/89 Japan Tobacco Company "Novel Strategies in Drug Design"

London, 12/1/89 IBC Conference on Recent "Role of Prodrugs and Soft ENGLAND Advances in Site-Specific Drugs in Drug Delivery and Chemical Delivery Systems Targeting Systems" Curriculum Vitae--Presentations Nicholas Bodor

Debrecen, 12/4/89 Medical University of "Redox Delivery Systems of HUNGARY Debrecen Drugs to the Brain"

Maui, 12/11-15/89 American College of Neuro- "Clinical Utilization of HI psychopharmacology Redox Drug Combinations"

Memphis, 2/12-14/90 College of Pharmacy "Novel Strategies to Design TN University of Tennessee Safer Drugs"

Cleveland, 2/15-16/90 College of Pharmacy "Site-Specific Chemical OH Case Western Reserve Delivery Systems" University

Reno, 2/25-28/90 AAPS Western Regional "Brain-Specific Delivery of NV Meeting Peptides and Related Compounds"

Palo Alto, 3/1/90 Syntex "Novel Strategies in Drug CA Design and Delivery"

Lake Ozark, 3/10-14/90 Higuchi Research Seminar "Delivery of Peptides to the MO Brain"

Bath, 3/31-4/8/90 The Biochemical Society "Design Strategies for Safer ENGLAND Drugs"

Amsterdam, 7/1-6/90 XIth International Congress "Drug Targeting by Site- THE of Pharmacology Specific Chemical Drug NETHER- Delivery Systems" LANDS

JAPAN:

Tokyo 7/16-18/90 Fifth Japanese-American Con- "Novel Site-Specific Chemical ference on Pharmacokinetics Drug Delivery Systems" and Biopharmaceutics

Kyoto 7/18-19/90 ONO Pharmaceutical Co. "Brain Delivery of Peptides"

Curriculum Vitae--Presentations Nicholas Bodor

Tokushima 7/22-23/90 Otsuka Pharmaceutical Co. "Brain Delivery of Neuro- peptides and Related Compounds"

Osaka 7/25-26/90 Fujisawa Pharmaceutical Co. "Delivery of Peptides to the Brain"

Tokyo 7/26/90 Nihon Medi-Physics "Technetium Chelates"

HUNGARY:

Debrecen 8/22/90 Hungarian Pharmaceutical "Recent Advances in the Society Design of Safer Drugs"

Budapest 8/23/90 Federation of European "Recent Advances in Site- Biochemical Societies Specific Chemical Delivery Systems"

Las Vegas, 11/4-8/90 AAPS Annual Meeting "Pharmacological Evaluation NV of Alprenolone Oxime--A New Potential Antiglaucoma Agent"

Gainesville, 2/6/91 Division of Cardiovascular Roundtable discussion on: "A FL Medicine, UF College of New Site-Specific Endo- Medicine vascular Drug Delivery Catheter System"

Charleston, 4/4/91 AAPS Regional Meeting "Topical Drug Targeting by SC Chemical Delivery Systems and Soft Drugs"

JAPAN:

Osaka 4/9/91 Takeda Chemical Industries, "Recent Advances in Inc. Chemical-Enzymatic Target- ing of Drugs"

Osaka 4/10/91 Otsuka Pharmaceutical Co., Ltd.

Curriculum Vitae--Presentations Nicholas Bodor

Osaka 4/11-12/91 ONO Minase Research Institute

Tokyo 4/15/91 Eisai Tsukuba Research Laboratories

Tokyo 4/16/91 Japan Tobacco Company "Novel Soft Drugs"

KOREA:

Suwon 4/18/91 Ajou University "Design of Soft Drugs"

Suwon 4/19/91 Korean Drug Delivery Sym- "Brain-Specific Drug posium Delivery"

Suwon 4/22/91 Korea Research Institute of "Design of Soft Drugs" Chemical Technology

Dallas, TX 5/6/91 Alcon Laboratories, Inc. "Enzymes in the Eye"

Gainesville, 5/10/91 Florida School on Apllied "Molecular Orbitals and Drug FL Molecular Orbital Theory Design"

Jamaica, NY 5/21/91 St. John's University "Chemical-Enzymatic Drug College of Pharmacy and Targeting" Health RelatedProfessions

San Diego, CA 6/6/91 Gensia Pharmaceutical Co. "Metabolism-Based Drug Design"

La Jolla, CA 6/7/91 Agouron Pharmaceutical Co. "Rational Design of Drugs Based on Metabolic Considerations"

Amsterdam, 7/8-13/91 Controlled Release Society "Chemical Delivery Systems THE Symposium for Brain Targeting of Drugs" NETHERLANDS

Basel, 7/12/91 F. Hoffmann-La Roche AG "Strategies to Design Safer SWITZER- Drugs" LAND

Curriculum Vitae--Presentations Nicholas Bodor

Tampa, 7/24/91 Bausch & Lomb, Inc. FL

Budapest, 8/17-22/91 33rd IUPAC Congress "Drug Discovery by HUNGARY Retrometabolism-- Concepts and Applications"

East Bruns- 9/30-10/1/91 Technology Management Group "Targeted Chemicals for wick, NJ Conference on "Pharmaceutical Imaging (Brain and Heart)" Markets in Imaging Agents and Related Products

Atlanta, 10/13-16/91 American College of Clinical "Topical Drug Targeting by GA Pharmacology Meeting Chemical Delivery and Soft Drugs"

Gainesville, 10/30/91 College of Pharmacy Honors "Metabolism-Based Drug FL Seminar Course in Design" Pharmaceutical Research

JAPAN: 11/23-30/91

Kyoto 11/26-28/91 ONO Pharmaceuticals

Itami 11/28/91 Senju Pharmaceutical Company "Drug Design Based on Retrometabolism Concepts"

Osaka 11/29/91 Otsuka

London, 12/6/91 IBC Conference--Drug "Drug Targeting by Chemical ENGLAND Delivery III Delivery and Soft Drugs"

Gainesville, 1/22-24/92 Short Course on Surface Science "Drug Targeting by Chemical FL in Pharmaceutical Technology Delivery and Soft Drugs"

King of 2/8-12/92 CAChe Scientific Conference "Chemistry by Design" Prussia, PA

Baltimore, 3/26-27/92 Johns Hopkins Oncology Center "Novel Methods of Drug MD Design"

Curriculum Vitae--Presentations Nicholas Bodor

JAPAN: 5/14-22/92

Tokushima 5/15/92 Otsuka Pharmaceutical Co. "Recent Advances in Retrometabolic Drug Design"

Osaka 5/18/92 Japan Tobacco Company

Itami 5/19/92 Senju Research Company

Kyoto 5/20/92 ONO Pharmaceutical Company

ISRAEL:

Jerusalem, 5/24-29/92 Second Jerusalem Conference on "Chemical-Enzymatic Pharmaceutical Sciences and Approaches to Drug Clinical Pharmacology Targeting: Retrometabolism Concepts"

Rehovot 5/25/92 Pharmos, Ltd.

Budapest, 6/1-4/92 Hungarian Academy of Sciences "Recent Results in HUNGARY Retrometabolic Drug Design"

Tarrytown, 6/8-10/92 Conference on Topical "Chemical Variability of NY Glucocorticoids with Increased Glucocorticoid Molecules: Benefit/Risk Ratio Application of the Soft Drug Concept to Topical Anti- inflammatory Agents"

Washington, 7/22-24/92 NIH/Drug Discovery Groups "Brain Targeting of DC for Alzheimer's Disease Peptides"

Miami, 8/12/92 IVAX "Novel Soft Drugs" FL

Madrid, 9/10/92 12th World Computer Congress "Computer Aided Drug SPAIN (Presentor: Dr. Alan Harget) Design: A Neural Network Approach"

Washington, 9/15-17/92 American College of Clinical "Development of New DC Pharmacology Corticosteroids"

Curriculum Vitae--Presentations Nicholas Bodor

Gainesville, 9/18,21, Frontiers of Human Knowledge "Drug Design and Discovery FL 23/92 (University-Wide Honors Based on Retrometabolism Course) Concepts"

Leiden, THE 10/9-11/92 Symposium on Drug Transport "The Application of Chemical NETHER- to the Brain: Concepts and Delivery Systems for Brain LANDS Strategies Targeting of Drugs"

Rehovot, 10/13-14/92 Pharmos Corporation "Phosphate and Phosphonate ISRAEL Delivery Systems"

Gainesville, 10/26, Faculty Honors Course "In Search of Magic Bullets" FL 28/92 University of Florida

San Antonio, 11/15-19/92 AAPS "Brain Targeting of Peptides" TX

Fort Worth, 11/19-20/92 Alcon "Chemical Delivery Systems TX for the Eye"

Chicago, 12/1/92 Helene Curtis, Inc "Novel Soft Anticholinergic IL Compounds"

Miami, 2/20-22/93 IVAX "Soft Drugs for the Treatment FL of Asthma"

Raleigh, 2/24/93 Cato Research, Ltd. "Soft Steroids for the NC Treatment of Colitis"

Amelia Island, 3/5-8/93 Pharmos "Soft Ophthalmic Drugs" FL

Garden City, 4/20-21/93 35th Annual Pharmacy "Application of NY Congress Retrometabolic Approaches for Design of Novel Ophthalmic Drugs"

Washington, 6/5-8/93 Patent Office "Novel Anionic Delivery DC System"

Curriculum Vitae--Presentations Nicholas Bodor

Edmonton, 6/20-25/93 13th American Peptide "Delivery of Peptides into Alberta, Symposium the Central Nervous System CANADA by Sequential Metabolism"

Szeged, 7/23-24/93 International Workshop "Strategies for Opening the HUNGARY on Molecular Mechanism Gateway to the Brain" Regulating the Permeability of the Blood-Brain Barrier

Rockville, 7/28-29/93 NIDA Technical Review "Targeting Drugs to the Brain MD Meeting on Opiate by Sequential Metabolism" Pharmacotherapy

Bethesda, 8/6/93 NIH Drug Discovery Group "Discovery of Novel Drugs MD Meeting for Alzheimer’s Disease: Project 3--Neuropeptides"

Novi, 8/8-10/93 Symposium on Ocular "The Application of Soft Drug MI Pharmacology Concepts to the Design of Ophthalmic Drugs"

Chicago, 8/22-27/93 206th ACS National Meeting "Brain Targeting of Peptides IL via Sequential Metabolism"

JAPAN:

Kyoto 9/2-4/93 International Symposium on "Peptide Delivery to the Brain Delivery of Protein Drugs - by Sequential Metabolism" The Next 10 Years

Kobe 9/6/93 Senju Pharmaceuticals

Tokyo 9/7/93 Japan Tobacco Company

Tsukuba 9/10/93 Upjohn Pharmaceuticals Ltd. "Soft Drugs Concept"

Bethesda, 9/28-29/93 NIDA Technical Review "Retrometabolic Approaches MD Meeting on Membranes and to Drug Targeting" Barriers: Targeted Drug Delivery Curriculum Vitae--Presentations Nicholas Bodor

Gainesville, 10/22, 25, Frontiers of Human Knowledge "Drug Design and Discovery FL 27/93 University of Florida Based on Retrometabolism Concepts"

London, 11/22-24/93 IBC Drug Delivery 4 "Site-Specific Drugs by ENGLAND Chemical Trransformations"

Washington, 12/2-3/93 IBC Allergic Disease and "Soft Drugs: A DC Asthma Retrometabolic Drug Design Concept"

JAPAN:

Tokyo 4/23/94 Hoshi University Lecture "Recent Studies on Cyclo- Meeting on Comprehensive dextrins and Their Use in Cyclodextrins Drug Delivery and Targeting"

Tokyo 4/25-28/94 7th International Cyclodextrins "Optimization of Drug Symposium Targeting by Combinations of Chemical Delivery Systems and Cyclodextrins"

Edmonton, 6/20-25/93 13th American Peptide "Delivery of Peptides into Alberta, Symposium the Central Nervous System CANADA by Sequential Metabolism"

Rockville, 7/28-29/93 NIDA Technical Review "Targeting Drugs to the Brain MD Meeting on Opiate by Sequential Metabolism" Pharmacotherapy

Chicago, 8/22-27/93 206th ACS National Meeting "Brain Targeting of Peptides IL via Sequential Metabolism"

Kyoto, 9/2-4/93 International Symposium on "Peptide Delivery to the Brain JAPAN Delivery of Protein Drugs - by Sequential Metabolism" The Next 10 Years

Rockville, 9/28-29/93 NIDA Technical Review "Retrometabolic Design MD Meeting on Membranes and Approaches to Drug Barriers: Targeted Drug Targeting" Delivery Curriculum Vitae--Presentations Nicholas Bodor

Tokyo, 4/25-28/94 7th International Cyclodextrins "Optimization of Drug JAPAN Symposium Targeting by Combinations of Chemical Delivery Systems and Cyclodextrins"

Washington, 8/21-25/94 208th Am. Chem. Soc. National "Design of Biologically Safer DC Meeting Chemicals Based on Retrometabolic Concepts"

Buenos Aires, 11/14-19/94 XV Panamerican Congress of "Retrometabolic Drug Design ARGENTINA Pharmacy and Biochemistry Concepts"

HUNGARY: 12/7-13/94 National Academy "Retrometabolic Drug Design Concepts"

Technical University "Computer-Assisted Drug Design"

Gedeon Richter Works "Soft Steroids"

Debrecen Medical University "Novel Safe Ophthalmic Drugs"

New Orleans, 1/26-29/95 AOPT Annual Meeting "Sequential Bioactivation of LA Methoxime Analogs of β- Adrenergic Antagonists in the Eye"

Anaheim, 4/2-7/95 209th Am. Chem. Soc. National "Optimization of Drug CA Meeting Targeting by Cyclodextrins"

Amelia 4/10-13/95 3rd Suncoast Workshop on the "The Application of the Island, FL Neurobiology of Aging Molecular Packaging Method to Brain Targeting of TRH Analogs"

San Diego, 4/28-30/95 Houghten Pharmaceutical Co. CA

Curriculum Vitae--Presentations Nicholas Bodor

Birmingham, 5/5/95 U. of Alabama Vision "Retrometabolic Approaches AL Research Ctr. Visiting for the Design of Novel Scholar Program Ophthalmic Drugs"

Thessaloniki, 5/19-20/95 4th Conference in Advanced "Retrometabolic Drug Design GREECE Medicinal Chemistry Concepts in Drug Targeting"

Hiroshima, 7/6-7/95 11th Annual Meeting of "Drug Targeting by Chemical JAPAN Japan Drug Delivery and Enzymatic Retrometabolic Systems Society Approaches to the Brain and Eye"

Heidelberg, 7/17/95 BioResearch, BASF Pharma/ "Chemical-Enzymatic GERMANY Knoll Pharmaceuticals Targeting of Drugs"

JAPAN:

Tokyo 9/1-10/31/95 Hoshi University Visiting Several Lectures on Drug Professorship Design

Tokyo 9/3-8/95 AFMC International "Targeted Drug Delivery to Medicinal Chemistry Sym- to the Brain Using Chemical posium, Plenary Session Delivery Systems"

Kobe 9/11-13/95 Academy of Pharmaceutical "Computer-Assisted Design Science and Technology, of Targeted Drugs Based on Plenary Session Retrometabolic Concepts"

Osaka 9/14/95 Fujisawa Pharmaceutical "Optimal Combination of Co., Ltd. Chemical-Enzymatic and Physical Drug Targeting Approaches"

Osaka 9/20/95 Ono Pharmaceutical Co., Ltd. "Retrometabolic Drug Design Approaches and Computer Assisted Design of New Drugs on Retrometabolic Concepts"

Osaka 9/22/95 Takeda Chemical Industries, Ltd. "Retrometabolic Drug Design Approaches"

Curriculum Vitae--Presentations Nicholas Bodor

SWITZERLAND:

Geneva 9/28-10/01/95 International Symposium on "Retrometabolic Design Experimental and Clinical Concepts in Ophthalmic Ocular Pharmacology and Drug Discovery" Pharmaceutics, Plenary Session

Milan, 10/02/95 BioResearch, BASF Pharma/ "Brain Targeting of Drugs" ITALY Knoll Pharmaceutical Co.

SINGAPORE 10/06/95 The National University of "Design and Development of Singapore Soft Drugs"

Ako, 10/12/95 Ostuka Pharmaceutical Co., Ltd. "Design of Safer Ophthalmic JAPAN Drugs"

Gainesville, 11/01/95 Frontiers Of Science "Designing Targeted Drugs FL for the Brain and Eye"

Budapest, 11/14/95 Induction into the Hungarian "The Chemical and Enzymatic HUNGARY Academy of Sciences, Plenary Basis of the Retrometabolic Session Drug Design Approaches"

Ann Arbor, 12/04-05/95 Parke-Davis "Retrometabolic Drug Design MI Design Approaches"

Frankfurt, 02/09/96 Drug Targeting Symposium, "Drug Targeting Based on GERMANY German Chemical Society Retrometabolic Drug Design Approaches"

Budapest, 02/05/96 Gedeon Richter, Ltd. "Brain Targeting Chemical HUNGARY Works of Gedeon Richter, Ltd."

Budapest, 04/01/96 8th International Cyclodextrin "Recent Studies on the Use HUNGARY Symposium and Structure of Cyclodextrin Complexes"

Gainesville, 04/19/96 Department of Neuroscience "Retrometabolic Approaches FL University of Florida to Drug Design and Targeting" Curriculum Vitae--Presentations Nicholas Bodor

SINGAPORE 07/04/96 The National University of "Recent Advances In Singapore Retrometabolic Drug Design"

Osaka, 07/09/96 Senju Pharmaceutical Co. "Novel Antiglaucoma Drugs" JAPAN

New York, 08/28/96 Forest Laboratories "Soft Drugs" NY

Budapest, 09/05-12/96 Institute for Drug Research "Issues in Drug HUNGARY Development"

Seattle, 10/27-31/96 American Association of "Drug Targeting Based On WA Pharmaceutical Scientists Retrometabolic Drug Design Annual Meeting & Exposition Approaches"

Gainesville, 11/18-20/96 Pharmacy Honors Seminar, "In "Retrometabolism-Based FL Search of Magic Bullets" Drug Design"

Ispra, 01/20-22/97 "Data Management in Computer- "Computer-Assisted Design of ITALY Aided Drug Design" Workshop New Drugs Based on Joint Research Centre Retrometabolic Concepts"

Brussels, 01/23-25/97 Janssen Pharmaceutica "The Application of Chemical BELGIUM Delivery Systems For Brain Targeting of Drugs"

Gainesville, 03/20/97 Univ. of FL Coll of Pharmacy "Issues in Drug Discovery FL Nat'l. Devel. Advisory Board and Targeting"

Austin, 04/03/97 University of Texas at Austin "Design of Safer Drugs Using TX College of Pharmacy Retrometabolic Approaches"

San Francisco, 04/13-17/97 National Meeting of the Amer. "Design of Biologically CA Chemical Society Safer Chemicals"

Amelia Island, 05/06-09/97 "1st Drug Optimization via "Retrometabolic Drug Design FL Retrometabolism Conference" Concepts" Center for Drug Discovery, University of Florida Curriculum Vitae--Presentations Nicholas Bodor

St. Petersburg, 05/23-24/97 Glaxo Dermatology Advisory "Overview of the Soft FL Board Meeting Molecule Concept"

Raleigh, 06/17/97 Glaxo Wellcome, Inc. "Retrometabolic Drug Design NC Approaches"

Gdansk, 07/09-12/97 6th Int'l Symp. on Molecular "Retrometabolic Approaches POLAND Aspects of Chemotherapy for Drug Targeting"

Budapest, 9/04/97 Chemical Works of Gedeon "Design of Soft Drugs" HUNGARY Richter

Frankfurt, 9/08/97 ASTA Medica "Design of Soft Drugs" GERMANY

Munich, 9/11-14/97 2nd Int'l Symp. on Exp. and "Targeted Drug Delivery to GERMANY Clin. Ocular Pharmacol. and Retina via Systemic Routes" Pharmaceutics

Chicago, 9/27-30/97 Abbott Laboratories, Acceptance "Retrometabolic Drug Design IL of Volwiler Research and Targeting Concepts" Achievement Award

Bethesda, 10/22-24/97 3rd Annual Mtg. of the Asn. for "Targeted Drug Delivery to MD Ocular Pharmacol. and Ther. Retina via Systemic Routes"

Arlington, 10/27-28/97 IBC's 7th Annual Conf. on "Design of Soft VA Asthma & Allergy Corticosteroids"

Budapest, 11/11/97 Institute for Drug Research "Drug Development Concepts" HUNGARY

Gainesville, 11/17 & Honors Seminar in Pharm. "Retrometabolism-Based Drug FL 11/19/97 Research, College of Pharmacy, Design: Making MBs Better University of Florida and Safer"

Osaka, 01/14/98 Santen Pharmaceutical Co., Ltd. "Design of Safer Ophthalmic JAPAN Drugs by Retrometabolic Approaches"

Curriculum Vitae--Presentations Nicholas Bodor

Hiroshima, 01/16/98 Hiroshima University School "Design of Safer Ophthalmic JAPAN of Medicine Drugs Using Retrometabolic Approaches"

Gainesville, 01/27/98 University of Florida Dep't. "Brain Targeting of Neuro- FL of Neuroscience pharmaceuticals by Chemical Delivery Systems"

Miami, 03/02/98 IVAX Corporation "Retrometabolic Drug Design FL and Targeting Approaches"

Saskatchewan, 03/26 & University of Saskatchewan "Retrometabolic Approaches CANADA 03/27/98 College of Pharmacy for Drug Design & Targeting"

Budapest, 4/07-11/98 Institute for Drug Research "The Past and Future of Drug HUNGARY Discovery Research"

Budapest, 5/06/98 Institute for Drug Research "Recent Advances In HUNGARY Retrometabolic Drug Design"

Paris, 5/25-28/98 2nd World Meeting on "Brain Targeting of FRANCE Pharmaceutics, Biopharm. Basic Amino Acids and and Pharm. Tech.; Inv. Speaker Their Redox Analogs and Session Chair Containing Peptides"

Santiago de 5/31-6/03/98 9th Intl. Symposium on "The Effect of 2- Compostela, Cyclodextrins; Hydroxypropyl-β SPAIN Inv. Speaker and Cyclodextrin on the Solubility, Session Chair Stability and Brain Targeting of Chemical Delivery Systems for Neuropeptides"

Tokyo, 6/09-11/98 Challenges for Drug Delivery "Retrometabolic Drug Design JAPAN and Pharmaceutical Technology; Approaches" Inv. Speaker and Session Chair

Budapest, 7/16-20/98 Institute for Drug Research, Ltd. “Neuropeptide Targeting HUNGARY to the Brain”

Reykjavik, 7/28-8/3/98 University of Iceland “Soft Drug Approach in ICELAND Drug Design”

Curriculum Vitae--Presentations Nicholas Bodor

Debrecen, 10/19-23/98 Medical Univ. of Debrecen; “Retrometabolic Concepts HUNGARY Scientific Symposium to for the Design of Safer Drugs” Celebrate 80th Anniversary

Gainesville, 10/28/98 Honors Seminar in Pharm. "Retrometabolism-Based Drug FL Research, College of Pharmacy Design: Making MBs Better University of Florida and Safer"

Budapest, 1/04-31/99 Institute for Drug Research "Computer Drug Design" & HUNGARY & the Hungarian Academy of "Computer Assisted Design of Sciences Soft Drugs"

Budapest, 3/23-4/02/99 Institute for Drug Research "Retrometabolism-Based HUNGARY & the Technical University "Drug Design" & "Graduate Of Budapest Education at the University of Florida"

Dresden, 4/18-20/99 Technical University of "Chemical Approaches GERMANY Dresden in the Design of Targeted Invited Speaker Drugs"

Jerusalem, 4/25-30/99 7th Euro. Congress of "Drug Targeting Using ISRAEL Biopharmaceutics & Retrometabolic Approaches" Pharmacokinetics and 5th Congress of the Euro. Fed. Of Pharmaceutical Sciences Invited Speaker & Session Co-Chair

Amelia Island, 5/11-14/99 2nd Retrometabolism Based "Recent Advances in FLORIDA Drug Design and Targeting Retrometabolic Drug Design" Conference Founder and Organizer

Monroe, 5/20-21/99 AAPS-SRDG 2nd Annual "Drug Targeting Using LOUISIANA Meeting Retrometabolic Approaches" Keynote Address

Curriculum Vitae--Presentations Nicholas Bodor

Groton, 5/24/99 Pfizer Central Research "Retrometabolic Drug Design CONNECTICUT Invited Lecturer and Targeting" & "Computational Approaches to Retrometabolic Drug Design and Targeting"

New Brunswick, 6/2/99 Bristol-Myers Squibb "Computer-Assisted Design of NEW JERSEY Invited Lecturer New Drugs Based on Retrometabolic Concepts" & "Recent Advances in Retrometabolic Design Approaches"

Beerse, 9/2-7/99 Janssen Pharmaceuticals "Computational Approaches to BELGIUM Invited Lecturer Retrometabolic Drug Design And Targeting"

Tampa, 9/21/99 Bausch and Lomb "Novel Soft Steroids for FLORIDA Pharmaceuticals Opthalmic Use" Invited Lecturer

Budapest, 9/23-30/99 Institute for Drug Research "Computer Assisted Soft Drug HUNGARY Invited Lecturer Design"

Gainesville, 10/25 & 27/99 Honors Seminar in Pharm. "Retrometabolic Design" FLORIDA Research, College of Pharmacy University of Florida

New Orleans, 11/14-18/99 AAPS Annual Meeting "Retrometabolic Approaches LOUISIANA and Exposition for Drug Design and Invited Lecturer Targeting"

Lisbon, 2/10-13/00 3rd Intl. Symposium on Ocular “The Creation of a Site Active PORTUGAL Pharmacology & Pharmaceutics (Soft) Steroid.” (ISOPP); Invited Lecturer

London, 2/18/00 Norton Healthcare “Design of a New Class of ENGLAND Soft Steroids”

Cincinnati, 4/28/00 Procter & Gamble “Brain Targeting of OHIO Pharmaceuticals Neuropeptides”

Curriculum Vitae--Presentations Nicholas Bodor

Paris, 7/07/00 27th Intl. Symp. On Controlled “Cyclodextrins and FRANCE Release of Bioactive Brain Delivery” Materials

Philadelphia, 8/29/00 Rohm and Haas Co. “Retrometabolic Drug PENNSYLVANIA Design and Targeting”

Gainesville, 10/23 & 25/00 Honors Seminar, In Search of "Retrometabolic Design" FLORIDA Magic Bullets”, Coll. of Pharmacy University of Florida

Indianapolis, 11/01/00 AAPS Annual Meeting “Retrometabolic Appr. to INDIANA and Exposition Design of Ophth. Drugs”

Budapest, 11/13-16/00 Semmelweiss Univ. of “The Högyes Lecture” HUNGARY Medicine

Osaka, 11/22/00 Takeda Chemical “Recent Results in JAPAN Industries, Ltd. Retrometabolic Drug Design”

Atlanta, 2/08/01 IBC 9th Annual Conf. On “Brain-Targeting of Drugs Georgia Alzheimer’s and Neuropeptides”

Tempe, 3/31/01 Muro Asta Medica “Design of Loteprednol ARIZONA Investigator Meeting on A Soft Corticosterid” LE Nasal Spray

Basel, 3/28/01 Roche Pharm., Ltd. and “Design of Retrometabolism- SWITZERLAND Novartis Pharma Based and Specific Receptor (two presentations) Oriented Drugs”

Hawthorne, 4/17/01 Taro Pharmaceuticals USA, Inc. “Design of Loteprednol NEW YORK Etabonate, A Novel Soft Steroid”

Amelia Island, 5/14/01 3rd Retrometabolism Based Drug “Design of a New Class of FLORIDA Design and Targeting Conf. Soft Corticosteroids”

Stockholm, 5/31/01 Stockholm University “Recent Advances in SWEDEN Retrometabolic Drug Design and Targeting Approaches” Curriculum Vitae--Presentations Nicholas Bodor

San Francisco, 10/25-28/01 Foundation Fighting Blindness “Design of Novel Ophthalmic CALIFORNIA Meeting, “Drug Delivery: Drugs Using Retrometabolic Focusing on the Posterior Principles” Segment of the Eye”

Gainesville, 11/05 & 07/01 Honors Seminar in Pharm. "Retrometabolic Design --- FLORIDA Research, College of Pharmacy Magic Bullets” University of Florida

Budapest, 2/13/02 Institute for Drug Research “Retrometabolic Drug HUNGARY Scientific Retreat Design”

Ventura, 2/24-3/01 Drug Carriers in Medicine & “Brain Drug Delivery CALIFORNIA Biology (Gordon Res. Conf.) via Redox Carriers”

Gainesville, 3/06-08/02 3rd Annual Florida Heterocyclic “The Use of Dihydropyridine FLORIDA Conference Pyridinium Salt Redox System for Development of Brain- Specific Drugs”

Taormina, 4/07-11/02 6th Eilat Conference on New “Talampanel” SICILY Antiepileptic Drugs

Reykjavik, 5/05-08/02 11th International “Theoretical Insights into the ICELAND Cyclodextrin Symposium Formation, Structure, and Energetics of Some Cyclodextrin Complexes”

Gainesville, 10/30 &11/01/02 Honors Seminar in Pharm. “Retrometabolic Design” FLORIDA Research, College of Pharmacy University of Florida

Budapest, 2/20/03 Institute for Drug Research “Drug Design and HUNGARY Annual Scientific Meeting Discovery”

Palm Coast, 5/11-14/03 4th Retrometabolism Based “Soft Corticosteroids: Design FLORIDA Drug Design and Targeting Considerations and Recent Conference Advances”

Curriculum Vitae--Presentations Nicholas Bodor

Tokyo, 2/05-06/04 Metabolism & Membrane “Retrometabolic Approaches JAPAN Transport in Drug Discovery in Drug Design and Targeting” and Devel. Conf. (MMT3D)

Osaka, 2/09/04 Takeda Chemical Ind., Ltd. “Computer Assisted Drug JAPAN (three lectures) Design” “Novel Approaches to Treat Sepsis” Use of AMPA Antagonists For Treatment of Neurological Diseases”

Budapest, 2/18/04 Institute for Drug Research “Design of Novel Soft HUNGARY Annual Scientific Meeting Steroids” (two lectures) “Recent Advances in Talampanel”

Sardinia, 5/08-13/04 Eilat VII Conference on New “Talampanel” ITALY Antiepileptic Drugs

Budapest, 5/17-19/04 Hungarian Biochemical “Retrometabolic Drug Design, HUNGARY Society Meeting CDS and Soft Drugs”

Honolulu, 6/12-17/04 Controlled Release Society “Drug Targeting to the Brain HAWAII 31st Annual Meeting by Chemical-Enzymatic Approaches”

Baltimore, 11/07-11/04 2004 AAPS Annual “Insights for Drug Design MARYLAND Meeting Based on Metabolic Activity Of the Eye – Soft Drugs and Chemical Delivery Systems”

NICHOLAS BODOR, Ph.D., D.Sc. PATENTS ISSUED

1. N. Bodor, L. Fey, M. Kircz and F. Hodosan, "Synthesis of the Deoxycorticosterone Acetate (DCA)," Rom. Pat. 48,094, January 11, 1967.

2. N. Bodor and D. Rotaru, "Synthesis of 4-Chlorotestosterone Acetate," Rom. Pat. 48,624, January 31, 1967.

3. O. Mantsch, N. Bodor and A. Becanu, "Synthesis of the 6-α-Methyl-β-acetoxy Progesterone (Provera)," Rom. Pat., February 2, 1967; Fr. Pat. 1,547,748, November 29, 1968.

4. N. Bodor and E. Silaghi, "Synthesis of the Chloramphenicol Palmitate," Rom. Pat. 51,893, March 26, 1969.

5. N. Bodor and O. Mantsch, " Synthesis of 5β-Androstan-3α, 6α-diol-17-one from 16,20- Oxido-3α,6α,20-triacetoy-pregnane," Reg. Rom Pat. 65,038, November 20, 1970.

6. O. Mantsch and N. Bodor, "Synthesis of the 17-α-Acetoxy-progesterone from Pregnane- 3α,6α-diol-20-one," Rom. Pat. 65-309, November 20, 1970.

7. O. Mantsch, N. Bodor, F. Hodosan, N. Serban, I. Jude and A. Balogh, "Synthesis of 3-(5α- Andostan-3α-6α,17β-triol-17α-yl)-Propiolic Acid," Reg. Rom. Pat., 65,309, November 20, 1970.

8. F. Hodosan, N. Serban, A. Balogh, I. Jude, O. Mantsch and N. Bodor, "Novel Process for 3β,17β-Dihydroxy-5-Androstene-17α-Propynoic Acid," Rom. Pat. 64,146/1970; U.S. Pat. 3,734,938, May 22, 1973.

9. N. Bodor, "Pro-Drug Forms of Digoxin," U.S. Pat. 3,884,905, May 20, 1975.

10. N. Bodor and J. Kaminski, "1,4-Dichloro-2,2,5,5-Tetrasubstituted-3,6-Piperazinediones," U.S. Pat. 3,891,649, June 24, 1975.

11. N. Bodor, K. Sloan and A. Hussain, "Novel, Transient Pro-Drug Forms of L-DOPA," U.S. Pat. 3,891,696, July 29, 1975.

12. N. Bodor and J. Kaminski, "3-Chloro-Tetrahydro-1,3-Oxazines or Oxazolidines," U.S. Pat. 3,897,425, July 29, 1975.

13. T. Higuchi, N. Bodor and E. Shek, "Novel Pro-Drug Derivatives of Pyridinium Aldoxime Type Cholinesterase Reactivators and Process for Preparing Same," U.S. Pat. 3,929,813, December 30, 1975.

14. N. Bodor and J. Kaminski, "3-Chloro-2-Oxazolidinones," U.S. Pat. 3,931,213, January 6, 1976.

15. T. Higuchi, N. Bodor and Y. Kuo, "Useful Pro-Drug Forms of Theophylline," U.S. Pat. 3,935,196, January 27, 1976.

16. N. Bodor and J. Kaminski, "3-Chloro-Tetrahydro-1,3-Oxazines or Oxazolines Spiro Substituted," U.S. Pat. 3,936,466, February 3, 1976.

17. N. Bodor, K. Sloan and A. Hussain, "Novel, Transient Pro-Drug Forms of L-DOPA Useful in the Treatment of Parkinson's Disease," U.S. Pat. 3,939,253, February 17, 1976.

18. N. Bodor and J. Kaminski, "Method for Inhibiting Bacterial Growth with Certain Selected 3- Chloro-Tetrahydro-1,3-Oxazines or Oxazolidines," U.S. Pat. 3,954,985, May 4, 1976.

19. N. Bodor and K. Sloan, "Certain Transient Pro-Drug Forms of Phenylbutazone," U.S. Pat. 3,957,803, May 18, 1976.

20. T. Higuchi, N. Bodor and E. Shek, "Novel Pro-Drug Derivatives of Pyridinium Aldoxime Type Cholinesterase Reactivators and Method of Using Same," U.S. Pat. 3,962,447, June 8, 1976.

21. N. Bodor and S. Yuan, "Novel Synthesis of Optically Active M-Acyloxy-α- [(Methylamino)Methyl]Benzyl Alcohols, the Pharmaceutically Acceptable Acid Addition Salts Thereof and Intermediate Useful in the Preparation Thereof," U.S. Pat. 3,966,749, June 29, 1976.

22. J. Kaminski and N. Bodor, "N-Chloro-Amino Acid Derivatives Activity," U.S. Pat. 3,966,796, June 29, 1976.

23. N. Bodor, "Soft Quaternary Surface Active Agents Exhibiting Antibacterial Activity," U.S. Pat. 3,989,711, November 2, 1976.

24. N. Bodor, "1-Hydrocarbonoyloxymethyl-3-carbamoyl or 3-Carboethoxy-Pyridinium Salts," U.S. Pat. 3,998,815, December 21, 1976.

25. N. Bodor, K. Sloan and A. Hussain, "Novel, Transient Pro-Drug Forms of L-DOPA," U.S. Pat. 3,998,799, December 21, 1976.

26. N. Bodor, K. Sloan and Y. Kuo, "Method for Synthesizing Certain Selected Pro-Drug Forms of Theophylline," U.S. Pat. 4,000,132, December 28, 1976.

27. J. Kaminski and N. Bodor, "Method of Inhibiting Bacterial Growth with Certain Selected 3- Chloro-2-Oxazolidinones," U.S. Pat. 4,000,393, December 28, 1976.

28. T. Higuchi, N. Bodor and Y. Kuo, "Useful Prodrug Forms of Theophylline," U.S. Pat. 4,002,756, January 11, 1977.

29. N. Bodor and J. Kaminski, "Brominating and Oxidizing Agent and Method of Using Same," U.S. Pat. 4,009,178, February 22, 1977.

30. N. Bodor and J. Kaminski, "Method of Arresting Bacterial Growth with Certain Selected Dichloro-2,2,5,5-Tetrasubstituted-3,6-Piperazinediones," U.S. Pat. 4,018,925, April 19, 1977.

31. N. Bodor, "Pro-Drug Forms of Digoxin and Method of Preparing and Using Same," U.S. Pat. 4 ,021,546, May 3, 1977.

32. N. Bodor and S. Yuan, "Novel Intermediates Useful in the Synthesis of Optically Active M- Acyloxy-α-[(Methylamino)Methyl]Benzyl Alcohols," U.S. Pat. 4,028,368, June 7, 1977.

33. N. Bodor, K. Sloan and A. Hussain, "Novel, Transient Produg Forms of L-DOPA," U.S. Pat. 4,035,507, July 12, 1977.

34. N. Bodor and S. Yuan, "Novel Synthesis for Preparing the Hydrochloride Salt of Selected Catecholamine Derivatives," U.S. Pat. 4,035,405, July 12, 1977.

35. N. Bodor and K. Sloan, "Novel Transient Acyl Derivatives of Phenylbutazone," U.S. Pat. 4,036,845, July 19, 1977.

36. J. Kaminski and N. Bodor, "Certain Chloroamino Esters of Pyridine Carboxylates and Derivatives Thereof," U.S. Pat. 4,036,843, July 19, 1977.

37. J. Kaminski and N. Bodor, "N-Chloro-Amino Acid Derivatives Exhibiting Antibacterial Activity," U.S. Pat. 4,045,578, August 30, 1977.

38. N. Bodor, "Labile Quaternary Ammonium Salts Useful in Binding Bile Acids in Warm- blooded Animals," U.S. Pat. 4,046,899, September 6, 1977.

39. N. Bodor and J. Kaminski, "3-Chloro-1,3-Oxazines or Oxazolidines as Antibacterial Agents," U.S. Pat. 4,049,818, September 20, 1977.

40. N. Bodor, "Selected Quaternary Ammonium Salts of Pilacarpine Useful in Reducing Intraocular Pressure in Warm-blooded Animals," U.S. Pat. 4,061,722, December 6, 1977.

41. N. Bodor and K. Sloan, "Treating Psoriasis with Transient Prodrug Forms of Xanthine Derivatives," U.S. Pat. 4,061,753, December 6, 1977.

42. N. Bodor, K. Sloan and A. Hussain, "N-Nicotinoyl-3,4-dinicotinoyloxy-L-phenylalanine and Derivatives, Pharmaceutical Compositions and Methods Containing Same," U.S. Pat. 4,065,566, December 27, 1977.

43. N. Bodor and K. Sloan, "Pro-drugs for the Improved Delivery of Certain Selected Anti- inflammatory Steroids," U.S. Pat. 4,069,322, January 17, 1978.

44. T. Higuchi, N. Bodor and Y. Kuo, "Stable Prodrug Forms of Theophylline," U.S. Pat. 4,085,214, April 18, 1978.

45. N. Bodor and S. Yuan, "Novel Optically Active M-Acyloxy-α[(Methylamino)- Methyl]Benzyl Alcohols and the Pharmaceutically Acceptable Acid Addition Salts Thereof," U.S. Pat. 4,088,783, May 9, 1978.

46. J. Kaminski and N. Bodor, "Novel Soft N-Chloroamino Alcohol Derivatives Exhibiting Antibacterial Activity," U.S. Pat. 4,092,420, May 30, 1978.

47. N. Bodor, "Method for Reducing Intraocular Pressure in Warm-blooded Animals," U.S. Pat. 4,094,983, June 13, 1978.

48. N. Bodor and K. Sloan, "Antibacterial Novel Soft N-Chloroamino Alcohol Derivatives," U.S. Pat. 4,115,588, September 19, 1978.

49. N. Bodor and K. Sloan, "Transient Pro-drug Forms of Phenylbutazone," U.S. Pat. 4,117,232, September 26, 1978.

50. N. Bodor, "Labile Quaternary Ammonium Salts Useful in Binding Bile Acids in Warm- blooded Animals," U.S. Pat. 4,120,959, October 17, 1978.

51. J. Kaminski and N. Bodor, "Novel Soft N-Chloroamino Alcohol Derivatives Exhibiting Antibacterial Activity," U.S. Pat. 4,132,805, January 2, 1979.

52. N. Bodor and K. Sloan, "1,2-Diphenyl,5-Ditrifluoroacetyloxy-4-Butyl5-Hydroxy-3- Pyrazoline," U.S. Pat. 4,139,709, February 13, 1979.

53. N. Bodor, "Labile Quaternary Ammonium Salts Useful in Binding Bile Acids in Warm- blooded Animals," U.S. Pat. 4,140,796, February 20, 1979.

54. N. Bodor, "Sympathomimetic Amines Exhibiting Anti-hemorrhoidal Activity," U.S. Pat. 4,145,441, March 20, 1979.

55. N. Bodor and T. Higuchi, "Nonbitter Tasting Potassium Product for Oral Administration to Warm-blooded Animals and Method for Preparing Same," U.S. Pat. 4,154,824, May 15, 1979.

56. N. Bodor and S. Yuan, "Intermediates Useful in the Synthesis of Optically Active M- Acyloxy-α[Methylamino)Methyl]Benzyl Alcohols," U.S. Pat. 4,158,005, June 12, 1979.

57. N. Bodor, "Novel 'Soft' Anticholinergic Agents Exhibiting Anti-secretory Activity," U.K. Appln. GB2010270A, published June 27, 1979.

58. N. Bodor, "Labile Non-Heterocyclic Quaternary Ammonium Salts/Esters as Transient Derivatives," U.S. Pat. 4,160,099, July 3, 1979.

59. N. Bodor and K. Sloan, “Novel Transient Pro-Drug Forms of Phenylbutazone and Oxyphenbutazone in Compositions and Methods of Use,” U.S. Pat. 4,169,147, September 25, 1979.

60. J. Kaminski and N. Bodor, "Antibacterially Active N-Chloroamino Ester Derivatives of Alkyl Carboxylates," U.S. Pat. 4,171,452, October 16, 1979.

61. N. Bodor and S. Yuan, "Intermediates Useful in the Preparation of Optically and Therapeutically Active m-Acyloxy-α-(Methyl-Amino)Methyl Benzyl Alcohols," U.S. Pat. 4,174,450, November 13, 1979.

62. N. Bodor and J. Zupan, “Esters of Cromoglycates,” U.S. Pat. 4,189,571, February 19, 1980.

63. N. Bodor, "Soft Quaternary Surface Active Agents and Method of Using Same," U.S. Pat. 4,204,065, May 20, 1980.

64. Bodor and K. Sloan, “Anti-acne and Anti-seborrhea Prodrug Derivatives of Progesterone,” U.S. Pat. 4,213,978, July 22, 1980.

65. N. Bodor and K. Sloan, "Esteramide Prodrugs of Anti-inflammatory Corticosteroids," U.S. Pat. 4,221,787, September 9, 1980.

66. N. Bodor and K. Sloan, "Thiazolidine Prodrugs for the Improved Delivery of Antiinflammatory Corticosteroids," U.S. Pat. 4,239,757, December 16, 1980.

67. J. Epstein and N. Bodor, "Novel Pyridinium Aldoximes Having Micellar Characteristics," U.S. Pat. 4,263,305, April 21, 1981.

68. N. Bodor and L. Freiberg, "Salts of Erythromycin A Esters," U.S. Pat. 4,264,765, April 28, 1981.

69. N. Bodor, K. Sloan and S. Pogany, "Novel Prodrugs of Biologically Active Agents Containing Mercapto Groups, Process for Preparing and Therapeutically Effective Composition Containing the Same," Eur. Pat. 81,102,940.4, May 14, 1981.

70. N. Bodor and K. Sloan, "Prodrugs for Improved Bioavailability of Certain ∆4 Keto-Steroidal Sex Hormones," U.S. Pat. 4,268,441, May 19, 1981.

71. N. Bodor and K. Sloan, "Novel, Transient Pro-drug Forms of Xanthine Derivatives and Their Use as Topical Antiinflammatory Agents," U.S. Patent 4,275,064, June 23, 1981.

72. N. Bodor and K. Sloan, "Prodrugs for the Improved Delivery of Halogen-Containing Glucocorticosteroids," U.S. Pat. 4,279,900, July 21, 1981.

73. N. Bodor, "Soft Steroids Having Antiinflammatory Activity," Belg. BE889,563 (Cl. CO7J) November 3, 1981.

74. N. Bodor, K. Sloan and S. Pogany, "Novel Derivatives of Bio-affecting Phenolic Compounds and Pharmaceutical Composition Containing Them," Eur. Pat. 81,106,277.7, December 2, 1981.

75. N. Bodor, K. Sloan and S. Pogany, “Novel Dopa/Dopamine Prodrugs,” U.S. Pat. 4,311,706, January 19, 1982.

76. N. Bodor, “Soft Quaternary Surface Active Agents,” U.S. Pat. 4,313,889, February 2, 1982.

77. N. Bodor, K. Sloan and S. Pogany, “Novel Sypathomimetic Amine Prodrugs,” U.S. Pat. 4,313,956, February 2, 1982.

78. N. Bodor, K. Sloan and S. Pogany, "Novel Inotropic Prodrugs," U.S. Pat. 4,340,603, July 20, 1982.

79. N. Bodor, K. Sloan and S. Pogany, "Prodrugs of 6-Mercaptopurine and 6-Mercaptopurine Ribosides and Therapeutic Compositions and Methods Employing Them," U.S. Pat. 4,443,435, April 17, 1984.

80. N. Bodor, "Brain Specific Drug Delivery," U.S. Pat. 4,479,932, October 30, 1984.

81. N. Bodor, "4,5αEpoxymorphinan-6-Spiro-2'-(4'-Carboxy, 1',3'-Thiazolidine) Derivatives," U.S. Pat. 4,496,570, January 29, 1985.

82. N. Bodor, "Brain-Specific Drug Delivery," U.S. Pat. 4,540,564, September 10, 1985.

83. N. Bodor, "Methods for Inducing Mydriasis in Animals," U.S., Pat. 4,594,356, June 10, 1986.

84. N. Bodor, K. Sloan and S. Pogany, “Novel Prodrugs of Biologically Active Agents Containing Mercapto Groups, Process for Preparing and Therapeutically Effective Composition Containing the Same,” Eur. Pat. 0038541, August 13, 1986.

85. N. Bodor, K. Estes and J. Simpkins, "Method and Compositions for Weight Control," U.S. Pat. 4,617,298, October 14, 1986.

86. N. Bodor, "Testicular-Specific Drug Delivery," U.S. Pat. 4,622,218, November 11, 1986.

87. N. Bodor and Y. Oshiro, "Certain 3-Pyridiniumesters of Mono- or Di-Lower Alkyl Carbamates Having Anticholinesterase Activity," U.S. Pat. 4,661,502, April 28, 1987.

88. N. Bodor, “Orally Active Heparin Salts Containing Multivalent Cationic Units,” U.S. Pat. 4,703,042, October 27, 1987.

89. N. Bodor, "Soft Steroids Having Ani-Inflammatory Activity," U.S. Pat. 4,710,495, December 1, 1987.

90. N. Bodor, "Brain-Specific Dopaminergic Activity Involving Dihydropyridine Carboxamides, Dihydroquinoline and Isoquinoline Carboxamides," U.S. Pat. 4,727,079, February 23, 1988.

91. N. Bodor, "Labile Quaternary Amminium Salts as Prodrugs," U.S. Pat. 4,727,151, February 23, 1988.

92. N. Bodor and Y. Ohshiro, "Anticholinesterase Pyridine Derivatives," European Pat. 122376 (GB, FR, DE), June 29, 1988.

93. N. Bodor, “Novel 4,5-g(a) Epoxymorphinan-6-Spiro-2’-(4’-Carboxy, 1’,3’-Thiazolidine) Derivatives,” Eur. Pat. 0144341, July 6, 1988.

94. N. Bodor and T. Loftsson, "Percutaneous Penetration Enhancer of Oleic Acid and 2-Ethyl- 1,3-Hexanediol," U.S. Pat. 4,764,381, August 16, 1988.

95. N. Bodor, "Brain-Specific Analogues of Centrally Acting Amines," U.S. Pat. 4,771,059, September 13, 1988.

96. P. Stacpoole and N. Bodor, "Certain Inositol-Nicotinate Ester Derivatives and Polyionic Complexes Therefore Useful for Treating Diabetes Mellitus, Hyperlipidemia and Lactic Acidosis," U.S. Pat. 4,801,597, January 31, 1989.

97. N. Bodor, “Orally Active Heparin Multiplets,” Eur. Pat. 0189427, February 8, 1989.

98. N. Bodor, "Brain Specific Drug Delivery," U.S. Pat. 4,824,850, April 25, 1989.

99. N. Bodor, "Physiological Means of Enhancing Transdermal Delivery of Drugs," U.S. Pat. 4,824,676, April 25, 1989.

100. N. Bodor, "Novel Redox Carriers for Brain-Specific Drug Delivery," U.S. Pat. 4,829,070, May 9, 1989.

101. N. Bodor, "Soft β-Adrenergic Blocking Agents," U.S. Pat. 4,829,086, May 9, 1989.

102. T. Loftsson and N. Bodor, “Sulfur-Substituted Phenylacetamides," U.S. Pat. 4,859,707, August 22, 1989.

103. W. Anderson, N. Bodor and J. Simpkins, "Method for Treating Male Sexual Dysfunction," U.S. Pat. 4,863,911, September 5, 1989.

104. N. Bodor, "Brain-Specific Delivery of Dopamine Utilizing Dihydropyridine/Pyridinium Salt-Type Redox Carriers," U.S. Pat. 4,880,816, November 14, 1989.

105. N. Bodor, "Brain-Specific Drug Delivery," U.S. Pat. 4,880,921, November 14, 1989.

106. N. Bodor and T. Loftsson, "Percutaneous Penetration Enhancer of Oleic Acid and 2-Ethyl- 1,3-Hexanediol," U.S. Pat. 4,885,174, December 5, 1989.

107. N. Bodor, "Amino Acids Containing Dihydropyridine Ring Systems for Site-Specific Delivery of Peptides to the Brain," U.S. Pat. 4,888,427, December 19, 1989.

108. N. Bodor, “Brain-Specific Analogues of Centrally Acting Amines,” Eur. Pat. 0174342, December 20, 1989.

109. N. Bodor and T. Loftsson, “Composition and Method for Enhancing Permeability of Topical Drugs,” U.S. Pat. 4,892,737, January 9, 1990.

110. N. Bodor, “Pharmaceutical Composition for Parenteral Administration,” Japan Pat. 2009825, January 12, 1990.

111. N. Bodor, "Brain-Specific Drug Delivery of Steroid Sex Hormones Cleaved from Pyridinium Carboxylates and Dihydro-Pyridine Carboxylate Precursors," U.S. Pat. 4,900,837, February 13, 1990.

112. N. Bodor, "Brain Specific Analogues of Centrally Acting Amines," U.S. Pat. 4,933,438, June 12, 1990.

113. N. Bodor, “Soft –g(b)-Adrenergic Blocking Agents,” Eur. Pat. 0174956, August 16, 1990.

114. N. Bodor, "Compounds for Site-Enhanced Delivery of Radionuclides and Uses Thereof," U.S. Pat. 4,963,688, October 16, 1990.

115. N. Bodor, "Novel Radiopharmaceuticals and Chelating Agents Useful in Their Preparation," U.S. Pat. 4,963,682, October 16, 1990.

116. N. Bodor, "Pharmaceutical Formulations for Parenteral Use," U.S. Pat. 4,983,586, January 8, 1991.

117. N. Bodor and T. Loftsson, "Percutaneous Penetration Enhancer of Oleic Acid and 2-Ethyl- 1,3-Hexanediol," U.S. Pat. 4,983,396, January 8, 1991.

118. J. Houdeshell, N. Bodor and M. Brewster, “Low Allergic Steroid Type Anesthetic/Hypnotic Agent,” Japan Pat. 3011018, January 18, 1991.

119. N. Bodor, “Soft Steroids Having Anti-Inflammatory Activity,” U.S. Pat. 4,996,335, February 26, 1991.

120. N. Bodor, "Improvements in Redox Systems for Brain-Targeted Drug Delivery," U.S. Pat. 5,002,935, March 26, 1991.

121. N. Bodor, "Physiological Means of Enhancing Transdermal Delivery of Drugs," U.S. Pat. 5,008,111, April 16, 1991.

122. N. Bodor, "Brain-Specific Drug Delivery," U.S. Pat. 5,008,257, April 16, 1991.

123. N. Bodor, "Labile Ketone Derivative of 3-Substituted-1-Alkylamino-2-Propranols and Their Use as Beta-Adrenergic Blockers," U.S. Pat. 5,017,618, May 21, 1991.

124. N. Bodor, "Redox Systems for Brain-Targeted Drug Delivery," U.S. Pat. 5,017,566, May 1, 1991.

125. N. Bodor, “Physiological Means of Enhancing Transdermal Delivery of Drugs,” Eur. Pat. 0198034, June 12, 1991.

126. N. Bodor, "Pharmaceutical Formulations for Parenteral Use," U.S. Pat. 5,024,998, June 18, 1991.

127. N. Bodor, "Labile Ketone Derivative of 3-Substituted-1-Alkylamino-2-Propranols and Their Use as β-Adrenergic Blockers," U.S. Pat. 609,788, September 2, 1991.

128. K. Rand, N. Bodor and W. Brey, "NMR-Assayable Ligand-Labelled Trifluorothymidine Containing Composition and Method for Diagnosis of HSV Infection," U.S. Pat. 5,053,215, October 1, 1991.

129. N. Bodor, "Quaternary Pyridinium Salts (as amended)," U.S. Pat. 5,079,366, January 7, 1992.

130. N. Bodor, "Brain-Specific Analogues of Centrally Acting Amines," U.S. Pat. 5,082,853, January 21, 1992.

131. N. Houdeshell, N. Bodor and M. Brewster, "Hypoallergenic Steroidal Anesthetic-Hypnotic Compositions," South African Pat. 90/3992, January 29, 1992.

132. N. Bodor, "Redox Carriers for Brain-Specific Drug Delivery," U.S. Pat. 5,087,618, February 11, 1992.

133. W. Anderson, N. Bodor and J. Simpkins, "Method for Treating Male Sexual Dysfunction," Can. Pat. 1,300,020, May 5, 1992.

134. N. Bodor, "Pharmaceutical Formulations for Parenteral Use," Australian Pat. 618995, June 1, 1992.

135. N. Bodor, "Redox Systems for Brain-Targeted Drug Delivery," Australian Pat. 619788, June 22, 1992.

136. N. Bodor, "Novel Radiopharmaceuticals and Chelating Agents Useful in Their Preparation," U.S. Pat. 5,136,038, August 4, 1992.

137. N. Bodor, “Soft Beta-Adrenergic Blocking Agents,” U.S. Pat. 5,135,926, August 4, 1992.

138. N. Bodor, "Compounds for Site-Enhanced Delivery of Radionuclides and Uses Thereof," U.S. Pat. 5,155,227, October 13, 1992.

139. W. Anderson, N. Bodor and J. Simpkins, “Method for Treating Male Sexual Dysfunction,” Eur. Pat. 0256668, November 4, 1992.

140. N. Bodor, "Targeted Drug Delivery Via Phosphonate Derivatives," U.S. Pat. 5,177,064, January 5, 1993.

141. N. Bodor, "Brain-Specific Drug Delivery," U.S. Pat. 5,187,158, February 16, 1993.

142. N. Bodor, "Labile Ketone Derivatives of 3-Substituted 1-Alkylamino-2-Propanols and Their Use as β-Adrenergic Blockers," Nor. Pat. 171,312, February 24, 1993.

143. R. Hammer and N. Bodor, “Anticholinergic Compounds, Pharmaceutical Compositions and Method of Treatment,” Eur. Pat. 0238982, March 10, 1993.

144. N. Bodor and T. Loftsson, “Transdermal Delivery System,” Eur. Pat. 0250542, March 17, 1993.

145. N. Bodor, “Soft Beta-Adrenergic Blocking Agents,” U.S. Pat. 5,202,347, April 13, 1993.

146. N. Bodor, "Pharmaceutical Formulations for Parenteral Use," Eur. Pat. 0335545, June 9, 1993.

147. N. Bodor, “Soft Steroids Having Anti-Inflammatory Activity,” Eur. Pat. 0334853, June 9, 1993.

148. R. Hammer and N. Bodor, "Anticholinergic Compounds, Compositions and Methods of Treatment," U.S. Pat. 5,223,528, June 29, 1993.

149. N. Bodor, "Method of Improving Oral Bioavailability of Carbamazepine," U.S. Pat. 5,231,089, July 27, 1993.

150. N. Bodor, "Redox Amino Acids and Peptides Containing Them," Eur. Pat. 0293071, September 1, 1993.

151. R. Hammer and N. Bodor, "Anticholinergic Compounds, Compositions and Methods of Treatment," U.S. Pat. 5,258,388, November 2, 1993.

152. J.Houdeshell, N. Bodor and M. Brewster, “Hypoallergenic Steroidal Anesthetic/Hypotnic Compositions,” Eur. Pat. 0399716, January 26, 1994.

153. N. Bodor, "Brain Specific Drug Delivery," Can. Pat. 1,327,566, March 8, 1994.

154. N. Bodor, "Brain Specific Analogues of Centrally Acting Amines," U.S. Pat. 5,296,483, March 22, 1994.

155. N. Bodor, "Brain-Enhanced Delivery of Neuroactive Peptides by Sequential Metabolism," PCT WO 94/06450, March 31, 1994.

156. N. Bodor, “3-Substituted-1-Alkylamino-2-Propanol as Beta-Adrenergic Effect Blocking Medicine,” Japan Pat. 6122624, May 6, 1994.

157. N. Bodor, "Labile Ketone Derivatives of 3-Substituted-1-Alkylamino-2-Propanols and Their Use as Beta-Adrenergic Blockers," Eur. Pat. 0283147, May 11, 1994.

158. N. Bodor, “Soft Beta-Adrenergic Blocking Agents,” U.S. Pat. 5,334,601, August 2, 1994.

159. N. Bodor, "Pharmaceutical Formulations for Parenteral Use," Irish Pat. No. 62095,

December 5, 1994.

160. N. Bodor, "Redox Amino Acids and Peptides Containing Them," Irish Pat. No. 62072, December 5, 1994.

161. N. Bodor, "Labile Ketone Derivatives of 3-Substituted-1-Alkylamino-2-Propanols and Their Use as Beta-Adrenergic Blockers," Irish Pat. 62828, February 14, 1995.

162. N. Bodor, "Redox Carriers for Brain-Specific Drug Delivery," U.S. Pat. 5,389,623, February 14, 1995.

163. N. Bodor, "Labile Ketone Derivatives of 3-Substituted-1-Alkylamino-2-Propanols and Their Use as β-Adrenergic Blockers," Can. Patent 1,335,286, April 18, 1995.

164. N. Bodor, "Targeted Drug Delivery Via Phosphonate Derivatives," U.S. Pat. 5,413,996, May 9, 1995.

165. R. Hammer and N. Bodor, "Anticholinergic Compounds, Compositions and Methods of Treatment," U.S. Pat., 5,418,244, May 23, 1995.

166. N. Bodor, "Pharmaceutical Formulations for Parenteral Use," Canadian Pat. 1,336,498, August 1, 1995.

167. N. Bodor, "Brain-Specific Drug Delivery," Eur. Pat. 0110955, August 23, 1995.

168. N. Bodor, “Mitigation of Beta-Adrenergic Blocking Agent,” Japan Pat. 7238017, September 12, 1995.

169. N. Bodor, “Soft Beta-Adrenergic Blocking Agents,” U.S. Pat. 5,482,961, January 9, 1996.

170. N. Bodor, "Brain-Specific Drug Delivery," U.S. Pat. 5,525,727, June 11, 1996.

171. N. Bodor, “Soft Beta-Adrenergic Blocking Agents” U.S. Pat. 5,576,332, November 19, 1996.

172. R. Hammer and N. Bodor, "Anticholinergic Compounds, Compositions and Methods of Treatment," U.S. Pat., 5,610,188, March 11, 1997.

173. N. Bodor, “Targeted Drug Delivery via Phosphonate Derivatives,” United Kingdom Pat. 0539493, March 26, 1997.

174. N. Bodor, “Targeted Drug Delivery via Phosphonate Derivatives,” Eur. Pat. 0539493; Ger. Pat P69125377; Austria Pat. E150759; March 26, 1997.

175. N. Bodor, “Brain-Specific Drug Delivery,” Singapore, Pat. 9790597-0, March 29, 1997.

176. N. Bodor, “Pharmaceutical Formulations for Parenteral Use,” Singapore, Pat. 9790596-2, March 29, 1997.

177. N. Bodor, "Targeted Drug Delivery via Phosphonate Derivatives," U.S. Pat. 5,618,803, April 8, 1997.

178. R. Hammer and N. Bodor, "Anticholinergic Compounds, Pharmaceutical Compositions and Methods of Treatment," U.S. Pat., 5,618,826, April 8, 1997.

179. N. Bodor, "Brain-Enhanced Delivery of Neuroactive Peptides by Sequential Metabolism," U.S. Pat., 5,624,894, April 29, 1997.

180. N. Bodor, “Pharmaceutical Formulations for Parenteral Use,” Japan Pat. 2643426, May 2, 1997.

181. W. Anderson, N. Bodor and J. Simpkins, "Method for Treating Male Sexual Dysfunction," Japan Pat., 2646568, May 9, 1997.

182. R. Hammer and N. Bodor, "Anticholinergic Compounds, Pharmaceutical Compositions and Methods of Treatment," U.S. Pat., 5,637,601, June 10, 1997.

183. N. Bodor, "Redox Amino Acids and Peptides Containing Them," U.S. Pat., 5,639,885, June 17, 1997.

184. R. Hammer and N. Bodor, "Anticholinergic Compounds, Pharmaceutical Compositions and Methods of Treatment," Japan Pat. 2672311, July 11, 1997.

185. N. Bodor, “Redox Systems for Brain-Targeted Drug Delivery,” Austria Pat. E164855; European Pat. 0327766; Germany P3856160; April 8, 1998.

186. N. Bodor, “Pharmaceutical Formulations for Parenteral Use,” Eur. Pat. 0335545, September 23, 1998.

187. N. Bodor, “Androstene Derivatives,” U.S. Pat. 5,981,517, November 9, 1999.

188. N. Bodor, “Androstene Derivatives,” Eur. Pat. EP 0 902 789 B1, January 23, 2002.

189. N. Bodor and M. Grant, “Compounds and Method for the Prevention and Treatment of Diabetic Retinopathy,” U.S. Pat. 6,440,933, August 27, 2002.

190. N. Bodor, “Inactive Metabolite Approach to Soft Drug Design,” U.S. Pat. 6,610,675, August 26, 2003.

PATENTS PENDING

Approximately twenty-five patent applications are pending. Updated: October 13, 2003 CURRICULUM VITAE

Name: Hartmut Derendorf

Born: August 6, 1953 in Dortmund, Germany

Address: 100494, College of Pharmacy University of Florida Gainesville, Florida 32610 Phone (352) 846-2726 Fax (352) 392-3249 E-mail: [email protected]

Home Address: 8708 SW 42nd Place Gainesville, Florida 32608 Phone (352) 335-0074 Fax (352) 384-0965

Present Position: Distinguished Professor and Chairman Dept. of Pharmaceutics, College of Pharmacy University of Florida

Previous Positions:

1993 - 2003 Professor Dept. of Pharmaceutics College of Pharmacy University of Florida

1987 - 1995 Chairman 1998 - Dept. of Pharmaceutics College of Pharmacy University of Florida

1987 - 1993 Associate Professor Dept. of Pharmaceutics College of Pharmacy University of Florida

1983 - 1987 Assistant Professor Dept. of Pharmaceutics College of Pharmacy University of Florida

Education

1972 - 1976 B.S. in Pharmacy, University of Münster, Germany

1977 Registered Pharmacist

1977 - 1979 Graduate Study of Pharmacy at University of Münster, Germany

1979 Dr. rer. nat. (Ph.D.) with a dissertation on "Biopharmaceutical investigations of weak analgesics" (summa cum laude)

1979 - 1980 Assistant Scientist Institute for Pharmaceutical Chemistry, University of Münster

1981 - 1982 Postdoctoral Fellow with E.R. Garrett, College of Pharmacy, University of Florida

Awards 1980 Award for the best dissertation University of Münster, Germany 1983 Rottendorf-Award for Outstanding Research in the Area of Pharmaceutical Sciences 1988 Fellow of the American College of Clinical Pharmacology (ACCP) 1994 McKeen-Cattell-Award for best publication in the Journal of Clinical Pharmacology 1995 Teaching Improvement Award, University of Florida 1996 Fellow of the American Association of Pharmaceutical Scientists (AAPS) 2000 Honorary Regent, American College of Clinical Pharmacology 2001 Honorary Fellowship, Slovakian Chemotherapy Society 2002 University of Florida Research Foundation Professorship 2003 Nathaniel T. Kwit Distinguished Service Award, American College of Clinical Pharmacology 2003 Research Achievement Award in Clinical Sciences, American Association of Pharmaceutical Scientists 2004 International Educator of the Year Award University of Florida 2005 Faculty Award in Pharmaceutical Sciences University of Utrecht, The Netherlands 2005 International Educator of the Year Award University of Florida 2007 CVS Professorship, College of Pharmacy, University of Florida 2007 International Educator of the Year Award University of Florida

Teaching Experience 1983 - present Teacher for Biopharmaceutics, Pharmacokinetics (undergraduate and graduate courses) and Clinical Pharmacokinetics, University of Florida 1990 - present Adjunct Professor for Pharmacokinetics at the Federal University of Rio Grande do Sul, Porto Alegre, Brazil 1981 - present Instructor at more than 20 courses on Pharmacokinetics, Biopharmaceutics and Clinical Pharmacokinetics in Germany, England, Brazil and U.S.A 1983 - 1990 Adjunct Lecturer for Pharmacokinetics and Biopharmaceutics at the University of Münster, Germany 1977 - 1980 Teaching assistant for courses in Medicinal Chemistry, Pharmacology for Pharmacists, Biochemistry for Pharmacists and Analytical Chemistry at University of Münster; Teacher for Pharmacology for Pharmacists at University of Münster; Teacher for Pharmacology and Toxicology at Schools for Pharmacy Technicians in Münster and Osnabrück

Textbooks 1983 H. Derendorf, Drugs - Applied Pharmacology for Pharmacists and Pharmacy Technicians (in German), 280 p., Deutscher Apotheker-Verlag, Stuttgart, Germany 1987 H. Derendorf and E.R. Garrett, Pharmacokinetics - Introduction into Theory and Practice" (in German), 175 p., Deutscher Apotheker -Verlag, Stuttgart, Germany 1988 H. Derendorf, Drugs - Applied Pharmacology for Pharmacists and Pharmacy Technicians (in German), 4th edition, 286 p., Deutscher Apotheker Verlag, Stuttgart, Germany 1994 H. Derendorf, Drugs - Applied Pharmacology for Pharmacists and Pharmacy Technicians (in German), 5th edition, 264 p., Deutscher Apotheker Verlag, Stuttgart, Germany 1995 E. Mutschler and H. Derendorf, Drug Actions (in English), 799 p., Deutscher Apotheker Verlag, Stuttgart, Germany 1995 H. Derendorf and G. Hochhaus, Handbook of Pharmacokinetic-Pharmacodynamic Correlations (in English), 483 p., CRC Press, Boca Raton, Florida 1997 J. Framm, M. Schäfer, H. Derendorf, Pharmaceutical Care (in German), 118 p., Deutscher Apotheker Verlag, Stuttgart, Germany 1998 H. Derendorf, M. Schmidt, Drugs - Applied Pharmacology for Pharmacists and Pharmacy Technicians (in German), 6th edition, 269 p., Deutscher Apotheker Verlag, Stuttgart, Germany 1998 J. Framm, M. Anschütz, H. Derendorf, D. Hammersdorfer, E. Heydel, A. Mehrwald, G. Schomaker, Drug Profiles (in German), 252 p., Deutscher Apotheker Verlag, Stuttgart, Germany 2001 J. Framm, M. Anschütz, H. Derendorf, D. Hammersdorfer, E. Heydel, A. Mehrwald, G. Schomaker, Drug Profiles (in German), 2nd edition, 294 p., Deutscher Apotheker Verlag, Stuttgart, Germany 2002 H. Derendorf, T. Gramatte, H.G. Schaefer, Pharmacokinetics - Introduction into Theory and Practice" (in German), 2nd edition, 175 p., Deutscher Apotheker -Verlag, Stuttgart, Germany 2002 J. Framm, D. Placek, M. Anschütz, H. Derendorf, D. Hammersdorfer, E. Heydel, A. Mehrwald, G. Schomaker, Profily leciv (Drug Profiles, in Czech), 277 p., Grada Publishing, Prague, Czech Republic 2003 H. Derendorf, M. Schulz, R. Wemhöner Pharmacology for Pharmacists and Pharmacy Technicians (in German), 7th edition, 304 p., Deutscher Apotheker Verlag, Stuttgart, Germany

Present Research Interest

Pharmacokinetics and pharmacodynamics of glucocorticoids and antibiotics drugs. Use of pharmacokinetic/pharmacodynamic modeling in drug development.

Affiliations

American College of Clinical Pharmacology American Association of Pharmaceutical Scientists American Pharmaceutical Association Florida Pharmacy Association German Pharmaceutical Society American Society for Clin. Pharmacology and Therapeutics American Association of Colleges of Pharmacy American Society for Microbiology European Society for Biomodulation and Chemotherapy International Society for Anti-infective Pharmacology Phi Lamda Sigma

Other Activities

President, American College of Clinical Pharmacology (2006- 2008)

President, International Society for Anti-infective Pharmacology (2004-2006)

Member, Scientific Organizing Committee, 2nd Symposium on Antimicrobial resistance in Animals and the Environment, Tours (2007)

Co-Chair, EUFEPS Conference on Optimizing Drug Discovery and Development- Integrating Systems Approaches into Pharmaceutical Sciences, Basel (2007)

Member, Program Committee, Pharmaceutical Sciences World Congress, Amsterdam (2007)

Member, Advisory Committee for Pharmaceutical Science Clinical Pharmacology Subcommittee, FDA (2002-2006)

Member, Scientific Advisory Board, Bavarian Academy of Clinical Pharmacy (2006-present)

Program Chairman, National Meeting of the American College of Clinical Pharmacology (2003)

Member of the International Pharmaceutical Education Advisory Committee of the American Association of Colleges of Pharmacy (2001-03)

Chair, AAPS Microdialysis Focus Group (2003)

Secretary, American College of Clinical Pharmacology (1996- 00)

Council Member, International Society for Anti-infective Pharmacology (1999-02)

Member of the Board of Regents, American College of Clinical Pharmacology (1991-00)

Member of the FDA Expert Panel on Oral Inhalation and Nasal Drug Products (OINDP) (1999-00)

Member of AAPS/PPDM Program Committee (1996/97)

Member, National RCMI Advisory Board, Florida A&M University (1992-05).

Member of Credentials Committee, American College of Clinical Pharmacology (1990-00).

Member of the Nutrition and Therapeutics Integrated Project Team of the NASA-JSC Space Medicine Program (1997-04).

Member of the AAPS Globalization Committee (1995)

National Chair of the AACP Meeting of Department Chairs of Pharmaceutics (1992).

Member of the Graduate Education and Research Committee (PDD) of the American Association of Pharmaceutical Scientists (1992-1993).

Program Chairman, National Meeting of the American College of Clinical Pharmacology (1992).

Chairman, Southeastern Regional Meeting of the American Association of Pharmaceutical Scientists 1991 and 1992.

President of the Southeastern Chapter of the American College of Clinical Pharmacology (1990-91).

Member of Scientific Excellence Committee, American Association of Pharmaceutical Scientists (1990-91).

Member of Scientific Program Committee, American College of Clinical Pharmacology (1989-1992, 1997).

Reviewer for J. Pharm. Sci., Int. J. Pharm., Pharm. Res., J. Pharmacokin. Biopharm., Life Sci., Biopharm. Drug Disp. and J. Pharm. Biomed. Anal.

Member of several ad-hoc NIH Study Sections (NCI, NIAID). Grant-Reviewer for the National Science Foundation. Grant Reviewer for the Italian Ministry for University and Research.

Book-Reviewer for Am. J. Pharm. Ed., J. Am. Chem. Soc. and J. Pharm. Sci.

Editorial Advisory Boards

Editor, International Journal of Clinical Pharmacology and Therapeutics

US-Editor, Editorial Board, Die Pharmazie.

Associate Editor, Journal of Clinical Pharmacology.

Member, Honorary Editorial Board, Clinical Pharmacokinetics.

Member, Editorial Board, Journal of Pharmacokinetics and Pharmacodynamics.

Member, Editorial Advisory Board, European Journal of Pharmaceutical Sciences.

Member, Editorial Board, Journal of Pharmaceutical Sciences

Member, Editorial Board, Antimicrobial Agents and Chemotherapy

Member, Editorial Board, Planta Medica

Member, Executive Editorial Board, Research Communications in Pharmacology and Toxicology.

Member, Editorial Board, Clinical Research and Regulatory Affairs.

Patents

H. Derendorf, M. Müller: Patent US 6,904,309 B2 (June 7, 2005), Microdialysis probes and methods of use.

List of Publications

1. P. Rohdewald, H. Derendorf, C.E. Elger, O. Knoll Quantification of the attenuation of pain sensation through evoked potentials after the application of mild analgesics. Z. EEG-EMG 11, 199-204 (1980).

2. H. Derendorf Electroencephalography in drug research. Dtsch. Apoth. Ztg. 120, 1474-1476 (1980).

3. H. Derendorf, P. Rohdewald Pharmaceutical availability of analgesic derivatives of salicylic acid. Dtsch. Apoth. Ztg. 121, 493-498 (1981).

4. H. Derendorf, P. Rohdewald Pharmaceutical availability of analgesic derivatives of pyrazolone. Dtsch. Apoth. Ztg. 121, 549-552 (1981).

5. H. Derendorf, P. Rohdewald Measurement of analgesic action by subjective and objective parameters. In "Pain research - Pain measurement - Chest pain", ed. by A. Struppler and M. Gessler, pg. 143-150, Springer (1981).

6. H. Derendorf, P. Rohdewald Pharmaceutical availability of analgesic derivatives of p-aminophenol in tablets. Dtsch. Apoth. Ztg. 121, 653-656 (1981).

7. P. Rohdewald, H. Derendorf, C.E. Elger, O. Knoll Evoked potentials as objective parameters for the analgesic response of weak analgesics. Adv. in Neurology 32, 375-381 (1982).

8. P. Rohdewald, H. Derendorf, G. Drehsen, C.E. Elger, O. Knoll Changes in cortical evoked potentials as correlates of the efficacy of weak analgesics. Pain 12, 329-34l (1982).

9. H. Derendorf, G. Drehsen, P. Rohdewald Cortical evoked potentials and saliva levels as basis for the comparison of pure analgesic to analgesic combinations. Pharmacology 25, 227-236 (1982).

10. H. Derendorf Phencyclidine - angel dust or devil's drug? Dtsch. Apoth. Ztg. 122, 2642-2646 (1982).

11. H. Derendorf, E.R. Garrett HPLC-Assay of methadone, phencyclidine and metabolites by post-column ion-pair extraction and "on-line" fluorescence detection of the counter-ion with applications. J. Pharm. Sci. 72, 630-635 (1983).

12. P. Rohdewald, G. Drehsen, E. Milsmann, H. Derendorf Relationship between saliva levels of metamizol metabolites, bioavailability and analgesic efficacy. Arzneimittelforschung (Drug Research) 33(II), 985-988 (1983).

13. H. Derendorf, G. Drehsen, P. Rohdewald In vivo- in vitro- correlations of salicylate saliva levels and continuous flow cell dissolution rates. Int. J. Pharm. 15, 167-175 (1983).

14. H. Derendorf, A.A. El-Koussi, E.R. Garrett Electrochemical chromatographic determination of morphine - antagonists in biological fluids with applications. J. Pharm. Sci. 73, 621-624 (1984).

15. H. Derendorf, G. Drehsen, P. Rohdewald Antipyrine - new light on an old drug. Pharm. Res. 1, 225-229 (1984).

16. P. Rohdewald, G. Drehsen, H. Derendorf Phenazone, the underestimated analgesic. Pharm. Ztg. 129, 552-558 (1984).

17. G. Drehsen, H. Derendorf, P. Rohdewald Pain relief- but when ? Münch. Med. Wschr. 126, 736-738 (1984).

18. P. Rohdewald, J. Rehder, G. Drehsen, G. Hochhaus, H. Derendorf, H. Möllmann Simultaneous determination of glucocorticoid alcohols, their succinates and hydrocortisone in plasma. J. Pharm. Biomed. Anal. 3, 565-573 (1985).

19. H. Derendorf, H. Möllmann, P. Rohdewald, J. Rehder, E.W. Schmidt Kinetics of methylprednisolone and its hemisuccinate ester. Clin. Pharm. Ther. 37, 502-507 (1985).

20. R.L. Yost, H. Derendorf Rapid chromatographic determination of cefotaxime and its metabolite in biological fluids. J. Chromatogr. 341, 131-138 (1985).

21. H. Derendorf, P. Rohdewald, H. Möllmann, J. Rehder, J. Barth, D. Neveling Pharmacokinetics of prednisolone after high doses of prednisolone hemisuccinate. Biopharm. Drug Disp. 6, 423-432 (1985).

22. E.R. Garrett, H. Derendorf, A. Mattha Pharmacokinetics of morphine and its surrogates VI: HPLC-Analyses and pharmacokinetics of methadone and its derived metabolites in dogs. J. Pharm. Sci. 74, 1203-1214 (1985).

23. H. Möllmann, P. Rohdewald, E.W. Schmidt, V. Salomon, H. Derendorf Pharmacokinetics of triamcinolone acetonide and its phosphate ester. Eur. J. Clin. Pharmacol. 29, 85-89 (1985).

24. P. Rohdewald, H. Derendorf, G. Drehsen, H.W. Granitzki, E. Neddermann The attenuation of experimental pain by pyrazolones. In "100 years pyrazolones", ed. by K. Brune and R. Lanz, Urban & Schwarzenberg, pg. 61-67 (1985).

25. H. Möllmann, J. Barth, K.M. Müller, P. Rohdewald, A. Grüner, H. Derendorf Pulmonary complications in intensive care patients- therapeutic approaches for the treatment of ARDS BGA-Schriften 486, 193-207 (1986).

26. H. Derendorf, P. Rohdewald, G. Hochhaus, H. Möllmann HPLC determination of glucocorticoid alcohols, their phosphates and hydrocortisone in aqueous solutions and biological fluids. J. Pharm. Biomed. Anal. 4, 197-206 (1986).

27. H. Derendorf, G. Mullersman, J. Barth, A. Grüner, H. Möllmann Pharmacokinetics of diclofenac sodium after intramuscular administration in combination with triamcinolone acetate. Eur. J. Clin. Pharmacol. 31, 363-365 (1986).

28. G. Mullersman, H. Derendorf Ranitidine - rapid analysis in biological fluids and determination of erythrocyte partitioning. J. Chromatogr. 381, 385-391 (1986).

29. G. Mullersman, V.P. Gotz, W.L. Russell, H. Derendorf Lack of clinically significant in vitro and in vivo interactions between ranitidine and sucralfate. J. Pharm. Sci. 75, 995-998 (1986).

30. R.L. Yost, H. Derendorf Pharmacokinetics of cefotaxime and its metabolite in normal and morbidly obese patients. Ther. Drug Monitor. 8, 189-194 (1986).

31. H. Derendorf, H. Möllmann, A. Grüner, D. Haack, G. Gyselby Pharmacokinetics and pharmacodynamics of glucocorticoid suspensions after intraarticular administration. Clin. Pharm. Ther. 39, 313-317 (1986).

32. H. Möllmann, J. Rehder, P. Rohdewald, B.E. Braun, J. Barth, H. Derendorf, B. Holtmann, A. Grüner Exogenous and endogenous glucocorticoid plasma level after intramuscular administration of diclofenac and triamcinolone diacetate Med. Welt 37, 371-377 (1986).

33. H. Möllmann, J. Barth, D. Haack, A. Grüner, D. Stroband G. Gyselby, P. Rohdewald, H. Derendorf Comparison of the kinetics and dynamics of intraarticular glucocorticoid suspensions. Akt. Rheumatol. 11, 55-60 (1986).

34. H. Derendorf, M. Kaltenbach Coulometric high-performance liquid chromatographic- analysis morphine in biological fluids. J. Pharm. Sci. 75, 1198-1200 (1986).

35. P. Rohdewald, H. Möllmann, J. Barth, J. Rehder, H. Derendorf Pharmacokinetics of dexamethasone and its phosphate ester. Biopharm. Drug Disp. 8, 205-212 (1987).

36. S.A. Stout, H. Derendorf Local treatment of respiratory infections with antibiotics. Drug Intel. Clin. Pharm. 21, 322-329 (1987).

37. H. Derendorf Erythrocyte - binding of cepholosporins. J. Pharm. Pharmacol. 39, 129-131 (1987).

38. P. Rohdewald, J. Rehder, H. Möllmann, J. Barth, H. Derendorf Pharmacokinetics and pharmacodynamics of prednisolone after extremely high doses of prednisolone hemisuccinate. Arzneimittelforschung (Drug Research), 37 (I), 194-198 (1987).

39. G. Mullersman, S. Toufflin, H. Derendorf HPLC analysis of buprenorphine in plasma and urine using coulometric detection. J. Pharm. Biomed. Anal. 5, 303-308 (1987).

40. S.A. Stout, C.M. Riley, H. Derendorf The correlation between the pharmacokinetics of melphalan and the pharmacodynamic response of neuroblastoma cells treated in vitro. Proc. Biopharm. Pharmacokin. II, 252-260 (1987).

41. H. Derendorf Pharmacokinetic evaluation of cefotaxime in normal and obese subjects. Proc. Biopharm. Pharmacokin. III, 11-18 (1987).

42. H. Möllmann, P. Rohdewald, J. Barth, H. Derendorf Effect of high doses of glucocorticoids on the kinetics of human white blood cells in vivo. Med. Klinik 83, 159-163 (1988).

43. G. Mullersman, H. Derendorf, M.E. Brewster, K.S. Estes, N. Bodor HPLC-Assay of a CNS directed estradiol chemical delivery system and its application after intravenous administration to rats. Pharm. Res. 5, 172-177 (1988).

44. H. Möllmann, P. Rohdewald, J. Barth, H. Derendorf, C. Möllmann, M. Verho. Comparative pharmacokinetics of methylprednisolone phosphate and hemisuccinate in high doses. Pharm. Res. 5, 509-513 (1988).

45. L.A. Berglund, H. Derendorf, J.W. Simpkins Desensitation of brain opiate receptor mechanisms by gonadal steroid treatments that stimulate luteinizing hormone secretion. Endocrinology 122, 2718-2726 (1988).

46. R.W. Townsend, V. Keuth, K. Embil, G. Mullersman, J.H. Perrin, H. Derendorf High-performance liquid chromatographic determination of conjugated estrogens in tablets. J. Chromatogr. 450, 414-419 (1988).

47. J. Limberg, H. Derendorf Pharmacy education in the U.S.A. Deut. Apoth. Ztg. 128, 2458-2461 (1988).

48. E.W. Schmidt, H.W. Möllmann, B.E. Braun, J. Barth, H. Derendorf Circadian theophylline levels after single and multiple administration of a sustained released dosage form. Therapiewoche 38, 2046-2051 (1988).

49. M.E. Brewster, K.S. Estes, T. Loftsson, R. Perchalski H. Derendorf, G. Mullersman, N. Bodor Improved delivery through biological membranes XXXI: Solubilization and stabilization of an estradiol chemical delivery system by modified ß-cyclodextrins. J. Pharm. Sci. 77, 981-985 (1988).

50. H. Derendorf Pharmacokinetic evaluation of -lactam antibiotics. J. Antimicrob. Chemother. 24, 407-413 (1989).

51. H. Möllmann, J. Barth, D. Schött, W.T. Ulmer, H. Derendorf, G. Hochhaus Differential therapeutic aspects of the treatment of toxic gas poisoning with glucocorticoids. Intensivmed. 26, 2-15 (1989).

52. M.E. Brewster, T. Loftsson, K.E. Estes, G. Mullersman, H. Derendorf, N. Bodor Water soluble complexes of a brain-targeted drug delivery system. Proc. Intl. Symp. Cyclodextr. 4, 399-405 (1989).

53. H. Möllmann, P. Rohdewald, J. Barth, M. Verho, H. Derendorf Pharmacokinetics and dose linearity testing of methylprednisolone phosphate. Biopharm. Drug Disp. 10, 453-464 (1989).

54. H. Derendorf, H. Möllmann, P. Rohdewald, D. Strohband, J. Barth, G. Hochhaus Pharmacokinetic aspects of intra-articular administration of glucocorticoids. in Willert, Heuck (ed.), New Results in Osteology, Springer, Berlin, pp. 474-481 (1989).

55. J. Barth, H.W. Möllmann, H. Derendorf, G. Hochhaus Pharmacodynamic interactions in systemic glucocorticoid therapy. in Willert, Heuck (ed.), New Results in Osteology, Springer, Berlin, pp. 533-541 (1989).

56. J. Barth, A. Möllmann, G. Hochhaus, H. Derendorf, H.W. Möllmann Absorption and transfer of water-soluble glucocorticoids through pulmonary membranes. Atemw.-Lungenkrkh. 15, 412-416 (1989).

57. E.W. Schmidt, H. Derendorf, B. Rasche, H.W. Möllmann Clinical and pharmacokinetic evaluation for the replacement therapy of -protease-inhibitor in patients with congenital 1 -protease-inhibitor deficiency and lung emphysema.1 Atemw.-Lungenkrkh. 15, 479-488 (1989).

58. H.G. Schaefer, D. Harrison, M.P. Hocking, J. Limberg, H. Derendorf Effect of truncal vagotomy and partial gastrectomy on the pharmacokinetics of propranolol enantiomers in dogs. J. Pharm. Sci. 79, 292-294 (1990).

59. H. Schreier, G. Hochhaus, R.J. Prankerd, H. Derendorf, M.E. Brewster, R.A. Baughman Pharmaceutical Biotechnology: A new graduate course at the University of Florida College of Pharmacy. Am. J. Pharm. Educ. 54, 46-50 (1990).

60. J. Limberg, M. LeBel, H. Derendorf Evaluation of free tissue concentrations of fleroxacin after oral administration. Pharm. Res. 7, 422-424 (1990).

61. E. Brunt, J. Limberg, H. Derendorf High performance liquid chromatographic-assay and erythrocyte partitioning of fleroxacin, a new fluoroquinolon antibiotic. J. Pharm. Biomed. Anal. 8, 67-71 (1990).

62. H. Derendorf, H. Möllmann, J. Barth Comparative pharmacokinetic evaluation of glucocorticoids after intraarticular administratation. Akt. Rheumatol. 15, 145-153 (1990).

63. F.F.T. Ververs, H.G. Schaefer, J.F. Lefevre, L.M. Lopez, H. Derendorf Simultaneous HPLC-assay of propranolol, diltiazem and diltiazem-metabolites in human plasma with application. J. Pharm. Biomed. Anal. 8, 535-539 (1990).

64. P. Adland-Davenport, M.P. Brown, J.D. Robinson, H. Derendorf Pharmacokinetics of amikacin in critically ill neonatal foals treated for presumed or confirmed sepsis. Equine Vet. J. 22, 18-22 (1990).

65. H. Derendorf, H. Möllmann, G. Voortman, F.A. van den Ouweland, L.B.A. van de Putte, G. Gevers, J. Dequeker, E. van Vliet-Daskalopoulou Pharmacokinetics of rimexolone after intra-articular administration. J. Clin. Pharmacol. 30, 476-479 (1990).

66. K. Dietzel, V. Keuth, K.S. Estes, M.E. Brewster, R. Clemmons, R. Vistelle, N.S. Bodor, H. Derendorf A redox-based system that enhances delivery of estradiol to the brain: Pharmacokinetic evaluation in the dog. Pharm. Res. 7, 879-883 (1990).

67. H.G. Schaefer, H. Spahn, L.M. Lopez, H. Derendorf Simultaneous determination of propranolol and 4- hydroxypropranolol enantiomers after chiral derivatization using reversed phase high-performance liquid chromatography. J. Chromatogr. 527, 351-359 (1990).

68. J. Limberg, D. Harrison, M.P. Hocking, H. Derendorf Theophylline absorption and gastric emptying after partial gastrectomy in dogs. J. Pharm. Sci. 79, 968-969 (1990).

69. M. Kaltenbach, S.H. Curry, H. Derendorf Extent of drug absorption at the time of peak plasma concentration in an open one-compartment body model with first-order absorption. J. Pharm. Sci. 79, 462 (1990).

70. K. Dietzel, K.S. Estes, M.E. Brewster, N.S. Bodor, H. Derendorf The use of hydroxypropyl- -cyclodextrin as a vehicle for intravenous administration of dexamethasone in dogs. Int. J. Pharm. 59, 225-230 (1990).

71. J. Barth, H. Fett, M. Pörtner, B.E. Braun, H. Möllmann, P. Rohdewald, J. Krämer, H. Derendorf Exogenous and endogenous glucocorticoid levels after epidural administration of glucocorticoid crystal suspensions in different volumes. Orthop. Praxis 26, 729-736 (1990).

72. H. Möllmann, B. Armbruster, J. Barth, H. Derendorf, O.W. Flörke, G. Hochhaus, C.R. Möllmann, P. Rohdewald, E.W. Schmidt Distribution and aggregation of crystals in glucocorticoid suspensions. Akt. Rheumatol. 15, 101-124 (1990).

73. C.D. Hepler, L.M. Strand, H. Derendorf The pharmacist and pharmaceutical care - future opportunities and responsibility. Pharmazeutische Zeitung 135, 3087-3092 (1990).

74. K.S. Estes, V. Keuth, K. Dietzel, M.E. Brewster, N.S. Bodor, H. Derendorf A redox-based chemical delivery system that enhances estradiol to the brain: Disposition studies in the rat. Pharm. Res.8, 1180-1185 (1991).

75. O. Makil, M. Kaltenbach, J. Limberg, D. Harrison, M.P. Hocking, H. Derendorf Pharmacokinetics of ranitidine after partial gastrectomy in dogs. J. Pharm. Sci. 80, 1034-1036 (1991).

76. H. Derendorf, H. Möllmann, J. Barth, C. Möllmann, S. Tunn, M. Krieg Pharmacokinetics and oral bioavailability of hydrocortisone. J. Clin. Pharmacol. 31, 473-476 (1991).

77. H. Möllmann, J. Barth, C. Möllmann, S. Tunn, M. Krieg, H. Derendorf Pharmacokinetics and rectal bioavailability of hydrocortisone acetate. J. Pharm. Sci. 80, 835-836 (1991).

78. H. Derendorf, H. Möllmann, M. Krieg, S. Tunn, C. Möllmann, J. Barth, H.J. Röthig Pharmacodynamics of methylprednisolone phosphate after single intravenous administration to healthy volunteers. Pharm. Res. 8, 263-268 (1991).

79. B. Wichert, H. Schreier, H. Derendorf Sensitive HPLC-assay for the determination of amikacin in human plasma. J. Pharm. Biomed. Anal. 9, 251-254(1991).

80. C.D. Page, M. Mautino, H. Derendorf, W. Mechlinski Multiple-dose pharmacokinetics of ketoconazole administered orally to gopher tortoises (Gopherus polyphemus). J. Zoo & Wildlife Med. 22, 191-198 (1991).

81. T. Loftsson, M.E. Brewster, H. Derendorf, N. Bodor 2-Hydroxypropyl- -cyclodextrin: Properties and usage in pharmaceutical formulations. PZ Wissenschaft 4, 5-10 (1991).

82. C.D. Page, M. Mautino, H. Derendorf, J.P. Anhalt Comparative pharmacokinetics of trimethoprim- sulfamethoxazole administered intravenously and orally to captive elephants. J. Zoo & Wildlife Med. 22, 409-416 (1991).

83. K.H. Rand, K. Gibbs, H. Derendorf, J. Graham-Pole Pharmacokinetics of intravenous immunoglobulin in bone marrow transplant patients. J. Clin. Pharmacol.31, 1151-1154 (1991).

84. K.S. Estes, P. Dewland, M.E. Brewster, H. Derendorf, N. Bodor A redox-based chemical delivery system (CDS) applied to estradiol. PZ Wissenschaft 4, 153-158 (1991).

85. G. Hochhaus, H. Derendorf, H. Möllmann, J. Barth A selective HPLC/RIA for dexamethasone and its prodrug dexamethasone-21-isonicotinate in biological fluids. J. Pharm. Biomed. Anal.9, 761-767 (1991).

86. M.A. Longer, H.G. Schaefer, H. Derendorf Fundamentals of assessing bioequivalence studies. PZ Wissenschaft 5, 15-22 (1992).

87. G. Hochhaus, L.S. Chen, A. Ratka, P. Druzgala, J. Howes, N. Bodor, H. Derendorf Pharmacokinetic characterization and tissue distribution of the new glucocorticoid soft drug loteprednol etabonate in rats and dogs. J. Pharm. Sci. 81, 1210-1215 (1992).

88. H. Schreier, K.J. McNicol, M. Ausborn, D.M. Soucy, H. Derendorf, A.A. Stecenko, R.J. Gonzalez-Rothi Pulmonary delivery of amikacin liposomes and acute liposome toxicity in the sheep. Int. J. Pharmac. 87, 183-193 (1992).

89. S. Tunn, H. Möllmann, J. Barth, H. Derendorf, M. Krieg Simultaneous measurement of cortisol in serum and saliva after different forms of cortisol administration. Clin. Chem. 38, 1491-1494 (1992).

90. G. Hochhaus, R. Hochhaus, G. Werber, H. Derendorf, H. Möllmann A selective HPLC/RIA for dexamethasone and its prodrug dexamethasone-21-sulphobenzoate sodium in biological fluids Biomedical Chromatography 6, 283-286 (1992).

91. H. Möllmann, H. Derendorf, J. Barth, C. Möllmann, S. Tunn, M. Krieg Bioavailability of hydrocortisone after rectal administration of hydrocortisone acetate foam. Med. Welt 43, 609-615 (1992).

92. H. Derendorf Choice of appropriate pharmacokinetic-pharmacodynamic models for predicting drug effects. Klin. Pharmakol. aktuell 3, 19-21 (1992).

93. J. Barth, M. Damoiseaux, H. Möllmann, K.H. Brandis, G. Hochhaus, H. Derendorf Pharmacokinetics and pharmacodynamics of prednisolone after intravenous and oral administration. Int. J. Clin. Pharmacol. Ther. Toxicol. 30, 317-324 (1992).

94. S. Mohammed, M. Butschkau, H. Derendorf A reversed phase liquid chromatographic method for the determination of codeine in biological fluids with application. J. Liq. Chromatogr. 16, 2325-2334 (1993).

95. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth, M. Krieg, S. Tunn, C. Möllmann Receptor-based pharmacokinetic-pharmacodynamic analysis of corticosteroids. J. Clin. Pharmacol. 33, 115-123 (1993).

96. T. Wagner, J. Barth, A. Tromm, C. Bigalke, S. Tunn, M. Krieg, H. Derendorf, H. Möllmann, B. May, G. Hochhaus Bioavailability of hydrocortisone after single and multiple dosing of hydrocortisone acetate foam in patients with chronic distal inflammatory bowel disease and healthy controls Akt. Koloproktol. 10, 223-226 (1993).

97. S.S. Mohammed, M. Christopher, P. Mehta, A. Kedar, S. Gross, H. Derendorf Increased erythrocyte and protein binding of codeine in patients with sickle cell disease J. Pharm. Sci 82, 1112-1117 (1993).

98. S.S. Mohammed, M. Ayass, P. Mehta, A. Kedar, S. Gross, H. Derendorf Codeine disposition in sickle cell patients compared with healthy volunteers J. Clin. Pharmacol. 33, 811-815 (1993).

99. J. Barth, G. Hochhaus, H. Derendorf, K.H. Lehr, T. Hoehler, H. Möllmann Prednicarbate after different forms of administration: plasma levels of drug and metabolites and effects on endogenous cortisol levels in humans Curr. Probl. Dermatol. 21, 147-156 (1993).

100. J. Barth, K.H. Lehr, H. Derendorf, H. Möllmann, T. Höhler, G. Hochhaus Studies on the pharmacokinetics and metabolism of prednicarbate after cutaneous and oral administration. Skin Pharmacol. 6, 179-186 (1993).

101. J. Barth, H. Möllmann, B. Armbruster, W. Flörke, G. Hochhaus, C. Möllmann, H. Derendorf Analysis of shape, particle size, distribution and aggregation of the crystals of sodium cromoglycate and nedocromil sodium Eur. J. Hosp. Pharm. 3, 20-28 (1993).

102. H. Möllmann, G. Hochhaus, A. Tromm, J. Barth, C. Bigalke, B. May, A. Möllmann, U. Schwegler, H. Derendorf, S. Tunn, M. Krieg Topical use of steroids in gastroenterology In "Inflammatory Bowel Diseases", ed. by J. Schölmerich, W. Kruis, H. Goebell, W. Hohenberger and V. Gross, pg. 343-349, Kluwer Academic Publishers, Dordrecht (1993).

103. M.L. Kaltenbach, S.S.Mohammed, G. Mullersmann, J.H. Perrin, H. Derendorf Pharmacokinetic evaluation of two ibuprofen-codeine combinations Int. J. Clin. Pharmacol. Ther. 32, 210-214 (1994).

104. G.N. Henderson, P.O. Whalen, R.A. Darr, S.H. Curry, H. Derendorf, T.G. Baumgartner, P.W. Stacpoole Development of an oral drug formulation for dichloroacetate and thiamine Drug Developm. Ind. Pharm. 20, 2425-2437 (1994).

105. H. Derendorf Pharmacokinetic/pharmacodynamic consequences of space flight J. Clin. Pharmacol. 34, 684-691 (1994).

106. H. Schreier, K.J. McNicol, D.B. Bennett, Z. Teitelbaum, H. Derendorf Pharmacokinetics of detirelix following intratracheal instillation and aerosol inhalation in the unanesthetized awake sheep Pharm. Res. 11, 1056-1059 (1994).

107. A. Nolting, H. Derendorf Pharmacokinetic Profile: Ceftazidime Antiinf. Drugs Chemoth. 12, 31-35 (1994).

108. R. Mies, J. van der Aa, C. Dixon, M. Kaltenbach, H. Derendorf, N. Gravenstein Computer-modulated patient-controlled analgesia: Preliminary evaluation of a prototype Regional Anesthesia 19, 270-276 (1994).

109. H. Derendorf Pharmacodynamic aspects of systemic drug delivery Drug Developm. Ind. Pharm. 20, 485-502 (1994).

110. J. Barth, H. Möllmann, T. Wagner, G. Hochhaus, H. Derendorf The validity of „equivalent doses‟ in corticosteroid therapy - a comparison of the clinical pharmacokinetics and pharmacodynamics of prednisolone and methylprednisolone Dtsch. Med. Wschr. 119, 1671-1676 (1994).

111. H. Schreier, J. Engel, K.J. McNicol, H. Derendorf, K. Groot, A.V. Schally Systemic delivery of the luteinizing hormone-releasing hormone (LH-RH) antagonist cetrorelix (SB-75) via pulmonary instillation in the unanesthetized awake sheep Eur. J. Pharm. Sci. 2, 303-306 (1994).

112. G. Hochhaus, R.J. Gonzalez-Rothi, A. Lukyanov, H. Derendorf, H. Schreier, T. Dalla Costa Assessment of glucocorticoid lung targeting by ex-vivo receptor binding studies in rats Pharm. Res. 12, 134-137 (1995).

113. H. Möllmann, S. Balbach, G. Hochhaus, J. Barth, H. Derendorf Pharmacokinetic-pharmacodynamic correlations of corticosteroids In “Handbook of pharmacokinetic-pharmacodynamic correlations”, ed. by H. Derendorf and G. Hochhaus, CRC Press, Boca Raton, 323-362 (1995).

114. A. Nolting, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of antibiotics In “Handbook of pharmacokinetic-pharmacodynamic correlations”, ed. by H. Derendorf and G. Hochhaus, CRC Press, Boca Raton, 363-388 (1995).

115. G. Hochhaus, H. Derendorf Dose optimization based on pharmacokinetic- pharmacodynamic modeling In “Handbook of pharmacokinetic-pharmacodynamic correlations”, ed. by H. Derendorf and G. Hochhaus, CRC Press, Boca Raton, 79-120 (1995).

116. H. Derendorf, G. Hochhaus, S. Rohatagi, H. Möllmann, J. Barth, H. Sourgens, M. Erdmann Pharmacokinetics of triamcinolone acetonide after intravenous, oral and inhaled administration J. Clin. Pharmacol. 35, 302-305 (1995).

117. H. Möllmann, G. Hochhaus, S. Rohatagi, J. Barth, H. Derendorf Pharmacokinetic/pharmacodynamic evaluation of deflazacort in comparison to methylprednisolone and prednisolone Pharm. Res. 12, 1096-1100 (1995).

118. L.B. Panton, G.J. Guillen, L. Williams, J.E. Graves, C. Vivas, M. Cediel, M.L. Pollock, L. Garzarella, J. Krumerman, H. Derendorf, D.T. Lowenthal The lack of effect of aerobic exercise training on propranolol pharmacokinetics in young and elderly adults J. Clin. Pharmacol. 35, 885-894 (1995).

119. A. Nolting, H. Derendorf Pharmacokinetic Profile: Ceftriaxone Antiinf. Drugs Chemoth. 13, 27-31 (1995).

120. S. Rohatagi, G. Hochhaus, H. Möllmann, J Barth and H. Derendorf Pharmacokinetic interaction between endogenous cortisol and exogenous corticosteroids Die Pharmazie, 50, 610-613 (1995).

121. S. Rohatagi, G. Hochhaus, H. Möllmann, J. Barth, E. Galia, M. Erdmann, H. Sourgens, H. Derendorf Pharmacokinetic/pharmacodynamic evaluation of triamcinolone acetonide after intravenous, oral and inhaled administration J. Clin. Pharmacol. 35, 1187-1193 (1995).

122. S. Rohatagi, U. Täuber, K. Richter, H. Derendorf Pharmacokinetic/pharmacodynamic modeling of cortisol suppression after oral administration of fluocortolone J. Clin. Pharmacol. 36, 311-314 (1996).

123. S. Rohatagi, A. Bye, A. Mackie, H. Derendorf Mathematical modeling of cortisol circadian rhythm and cortisol suppression Eur. J. Pharm. Sci. 4, 341-350 (1996).

124. T. Dalla Costa, H. Derendorf AUIC - a general target for the optimization of dosing regimens of antibiotics? Ann. Pharmacother. 30, 1024-1028 (1996).

125. H. Möllmann, G. Hochhaus, S. Rohatagi, J. Barth, H. Derendorf, M. Krieg, H. Weisser, A. Möllmann Pharmacokinetics and pharmacodynamics of cloprednol Int. J. Clin. Pharmacol. Ther. 34, 1-5 (1996).

126. H. Möllmann, M. Wagner, J. Barth, H. Derendorf, M. Schulz Fluticasone, a new glucocoritcoid for inhalation (in German) Pharm. Ztg. 141, 3662-3672 (1996).

127. A. Kovar, C. Schäfer, H. Derendorf Pharmacokinetic Profile: Cefepime Antiinf. Drugs Chemoth. 14, 95-103 (1996).

128. A. Nolting, T. Dalla Costa, R. Vistelle, K.H. Rand, H. Derendorf Determination of free extracellular concentrations of piperacillin by microdialysis J. Pharm. Sci. 85, 369-372 (1996).

129. A. Nolting, T. Dalla Costa, K.H. Rand, H. Derendorf Pharmacokinetic-pharmacodynamic modelling of the antibiotic effect of piperacillin Pharm. Res. 13, 91-96 (1996).

130. H. Derendorf, T. Dalla Costa Pharmacokinetics of piperacillin, tazobactam and its metabolite in renal impairment Int. J. Clin. Pharmacol. Ther. 34, 482-488 (1996).

131. H. Möllmann, J. Barth, G. Hochhaus, A. Möllmann, H. Derendorf, A. Tromm Concepts of corticosteroid therapy of chronic inflammatory bowel disease: topical vs. systemic administration (in German) In “Corticosteroid therapy of chronic inflammatory bowel disease”, ed. by B. May and H. Möllmann, Falk Foundation, 69-90 (1996).

132. G. Hochhaus, H. Derendorf, H. Möllmann, J. Barth, R. Hochhaus Pharmacodynamic aspects of corticosteroid effects (in German) In “Corticosteroid therapy of chronic inflammatory bowel disease”, ed. by B. May and H. Möllmann, Falk Foundation, 91-117 (1996).

133. H. Derendorf, H. Möllmann, G. Hochhaus, J. Barth Kinetic/dynamic interrelationships as basis for rational therapy (in German) In “Corticosteroid therapy of chronic inflammatory bowel disease”, ed. by B. May and H. Möllmann, Falk Foundation, 119-135 (1996).

134. H. Möllmann, G. Hochhaus, A. Tromm, P. Froehlich, A. Möllmann, M. Krieg, H. Weisser, H. Derendorf, J. Barth Pharmacokinetics and pharmacodynamics of budesonide-pH- modified release capsules (in German) In “Corticosteroid therapy of chronic inflammatory bowel disease”, ed. by B. May and H. Möllmann, Falk Foundation, 149-167 (1996).

135. R. Gonzalez-Rothi, S. Suarez, G. Hochhaus, H. Schreier, A. Lukyanov, H. Derendorf, T. Dalla Costa Pulmonary targeting of liposomal triamcinolone acetonide phosphate Pharm. Res. 13, 1699-1703 (1996).

136. B.G. Danielson, T. Salmonson, H. Derendorf, P. Geisser Pharmacokinetics of iron(III)-hydroxide sucrose complex after a single i.v. dose in healthy volunteers Arzneimittelforschung (Drug Research) 46, 615-621 (1996).

137. A. Suri, M. Kaltenbach, B. Grundy, H. Derendorf Pharmacodynamic evaluation of codeine using tooth pulp evoked potentials J. Clin. Pharmacol. 36, 1126-1131 (1996).

138. S. Rohatagi, A. Bye, C. Falcoz, A. Mackie, B. Meibohm, H. Möllmann, H. Derendorf Dynamic modeling of cortisol reduction after inhaled administration of fluticasone propionate J. Clin. Pharmacol. 36, 938-941 (1996).

139. H. Möllmann, J. Barth, G. Hochhaus, A. Möllmann, H. Derendorf, A. Tromm Principles of topical versus systemic corticoid treatment in inflammatory bowel disease in „Glucocorticoid Therapy in Chronic Inflammatory Bowel Disease‟, ed. by H. Möllmann and B. May, Kluwer, 42-60 (1996).

140. G. Hochhaus, H. Derendorf, H. Möllmann, J. Barth, R. Hochhaus Pharmacodynamic aspects of glucocorticoid action in „Glucocorticoid Therapy in Chronic Inflammatory Bowel Disease‟, ed. by H. Möllmann and B. May, Kluwer, 61-79 (1996).

141. H. Derendorf, H. Möllmann, G. Hochhaus, J. Barth Kinetic/dynamic interrelationships as basis for rational therapy in „Glucocorticoid Therapy in Chronic Inflammatory Bowel Disease‟, ed. by H. Möllmann and B. May, Kluwer, 80-98 (1996).

142. H. Möllmann, G. Hochhaus, A. Tromm, P. Froehlich, A. Möllmann, M. Krieg, H. Weisser, H. Derendorf, J. Barth Pharmacokinetics and pharmacodynamics of budesonide pH- modified release capsules in „Glucocorticoid Therapy in Chronic Inflammatory Bowel Disease‟, ed. by H. Möllmann and B. May, Kluwer, 107-120 (1996).

143. A. Suri, B. Grundy, H. Derendorf Pharmacokinetics and pharmacodynamics of enantiomers of ibuprofen and flurbiprofen after oral administration Int. J. Clin. Pharm. Ther. 35, 1-8 (1997).

144. H. Sourgens, H. Derendorf, H. Schifferer Pharmacokinetic profile of cefaclor Int. J. Clin. Pharmacol. Ther. 35, 374-380 (1997).

145. A. Suri, K.S. Estes, G. Geisslinger, H. Derendorf Pharmacokinetic-pharmacodynamic relationships for analgesics Int. J. Clin. Pharmacol. Ther. 35, 307-323 (1997).

146. M. Brewster, W. Anderson, A. Webb, L.M. Pablo, D. Meinsma, D. Moreno, H. Derendorf, N. Bodor, E. Pop Evaluation of a brain-targeting zidovudine chemical delivery system in dogs Antimicrob. Agents Chemother. 41, 122-128 (1997).

147. A. Kovar, A. Nolting, H. Derendorf Microdialysis for the determination of unbound tissue concentrations (in German) PharmUZ 26, 17-23 (1997).

148. A. Kovar, T. Dalla Costa, H. Derendorf Comparison of plasma and free tissue levels of ceftriaxone in rats using microdialysis J. Pharm. Sci. 86, 52-56 (1997).

149. G.N. Henderson, S.H. Curry, H. Derendorf, E.C. Wright, P.W. Stacpoole Pharmacokinetics of dichloroacetate in adult patients with lactic acidosis J. Clin. Pharmacol. 37, 416-425 (1997).

150. M.E. Brewster, W.R. Anderson, D. Meinsma, D. Moreno, A.I. Webb, L. Pablo, K.S. Estes, H. Derendorf, N. Bodor, R. Sawchuk, B. Cheung, E. Pop Intravenous and oral pharmacokinetic evaluation of a 2- hydroxypropyl- -cyclodextrin-based formulation of carbamazepine in the dog: Comparison with commercially available tablets and suspensions J. Pharm. Sci. 86, 335-339 (1997).

151. B. Meibohm, H. Derendorf Basic concepts of pharmacokinetic/pharmacodynamic (PK/PD) modeling Int. J. Clin. Pharmacol. Ther. 35, 401-413 (1997).

152. T. Dalla Costa, A. Nolting, K. Rand, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of the in- vitro antiinfective effect of piperacillin-tazobactam combinations Int. J. Clin. Pharmacol. Ther. 35, 426-433 (1997).

153. H. Derendorf, H. Möllmann, G. Hochhaus, B. Meibohm, J. Barth Clinical PK/PD modeling as a tool in drug development of corticosteroids Int. J. Clin. Pharmacol. Ther. 35, 481-488 (1997).

154. B. Meibohm, G. Hochhaus, S. Rohatagi, H. Möllmann, J. Barth, M. Wagner, M. Krieg, R. Stöckmann, H. Derendorf Dependency of cortisol suppression on the administration time of inhaled corticosteroids J. Clin. Pharmacol. 37, 704-710 (1997).

155. S. Rohatagi, S. Kan, H. Derendorf Non-compartmental analysis of pharmacokinetic data after multiple intravenous and oral administration Pharmazie 52, 529-532 (1997).

156. G. Hochhaus, H. Möllmann, H. Derendorf, R.J. Gonzalez- Rothi Pharmacokinetic/pharmacodynamic aspects of aerosol therapy using glucocorticoids as a model J. Clin. Pharmacol. 37, 881-892 (1997).

157. H. Möllmann, H. Derendorf, J. Barth, B. Meibohm, M. Wagner, M. Krieg, H. Weisser, J. Knöller, A. Möllmann, G. Hochhaus Pharmacokinetic/pharmacodynamic evaluation of systemic effects of flunisolide after inhalation J. Clin. Pharmacol. 37, 893-903 (1997).

158. A. Kovar, H. Derendorf Plasma and free tissue concentrations – significance for the evaluation of antibiotics (in German) Krankenhauspharmazie 18, 564-567 (1997).

159. S. Rohatagi, J. Barth, H. Möllmann, G. Hochhaus, A. Soldner, C. Möllmann, H. Derendorf Pharmacokinetics of methylprednisolone and prednisolone after single and multiple oral dosing J. Clin. Pharmacol. 37, 916-925 (1997).

160. M. Müller, B. Rohde, A. Kovar, A. Georgopoulos, H.G. Eichler, H. Derendorf Relationship between plasma and free interstitial concentrations of cefodizime and cefpirome in muscle and subcutaneous adipose tissue of healthy volunteers measured by microdialysis J. Clin. Pharmacol. 37, 1108-1113 (1997).

161. H. Derendorf Pharmacokinetic and pharmacodynamic properties of inhaled corticosteroids in relation to efficacy and safety Resp. Med. 91A, 22-28 (1997).

162. G. Hochhaus, P. Froehlich, R. Hochhaus, A. Möllmann, H. Derendorf, H. Möllmann A selective HPLC/RIA for the determination of budesonide J. Pharm. Biomed. Anal. 17, 1235-1242 (1998).

163. H. Derendorf, G. Hochhaus Pharmacodynamic aspects of drug delivery Klin. Pharmakol. 15, 10-18 (1998).

164. H. Möllmann, M. Wagner, B. Meibohm, G. Hochhaus, J. Barth, R. Stöckmann, M. Krieg, H. Weisser, C. Falcoz, H. Derendorf Pharmacokinetic and pharmacodynamic evaluation of fluticasone after inhaled administration Eur. J. Clin. Pharmacol. 53, 459-467 (1998).

165. D. Gravenstein, A. Suri, H. Derendorf, J. Koska Influence of plasma expansion on plasma protein binding of ketorolac J. Clin. Anesth. 10, 464-468 (1998).

166. H. Derendorf, G. Hochhaus, B. Meibohm, H. Möllmann, J. Barth Pharmacokinetics and pharmacodynamics of inhaled corticosteroids J. Allergy Clin. Immunol. 101, S440-446 (1998).

167. E. Liang, H. Derendorf Pitfalls in pharmacokinetic multi-compartmental analysis J. Biopharm. Pharmacokin. 26, 247-260 (1998).

168. S.A. Lottenberg, D. Gianella-Neto, H. Derendorf, M. Rocha, A. Bosco, S.V. Carvalho, A.E. Moretti, A.C. Lerario, B.L. Wajchenberg Effect of fat distribution on the pharmacokinetics of cortisol in obesity Int. J. Clin. Pharm. Ther. 36, 501-505 (1998).

169. B. Meibohm, H. Möllmann, M. Wagner, G. Hochhaus, A. Möllmann, H. Derendorf The clinical pharmacology of fluticasone propionate Rev. Contemp. Pharmacother. 8, 535-549 (1998).

170. Hämmerlein, H. Derendorf, D. Lowenthal Pharmacokinetic and pharmacodynamic changes in the elderly – clinical implications Clin. Pharmacokin. 35, 49-64 (1998).

171. H. Sourgens, R. Hoerr, A. Biber, H. Steinbrede, H. Derendorf KA 672-HCl, a neuronal activator against dementia: Tolerability, safety and preliminary pharmacokinetics after single and multiple oral doses in healthy male and female volunteers J. Clin. Pharm. 38, 373-381 (1998).

172. T. Dalla Costa, A. Nolting, A. Kovar, H. Derendorf Determination of free interstitial concentrations of piperacillin-tazobactam combinations by microdialysis J. Antimicrob. Chemother. 42, 769-778 (1998).

173. H. Möllmann, M. Wagner, J. Barth, H. Derendorf, M. Schulz Broncholytics/Antiasthmatics – Fluticasone In “Offizin und Praxis 16/17”, ed. by H. Morck, H. Liekfeld, L. Schneider, Govi-Verlag, 105-113 (1998).

174. S. Modric, A.I. Webb, H. Derendorf Pharmacokinetics and pharmacodynamics of tilmicosin in sheep and cattle, J. Vet. Pharmacol. Ther. 21, 444-452 (1998).

175. M. Wagner, R. Stöckmann, A.C. Möllmann, G. Hochhaus, H. Derendorf, J. Barth, H. Möllmann Fluticasone propionate: First long-acting inhaled corticosteroid Atemwegs- und Lungenerkrank. 25, 580-598 (1999).

176. A. de la Peña, H. Derendorf Pharmacokinetic properties of beta-lactamase inhibitors Int. J. Clin. Pharmacol. Ther. 37, 63-75 (1999).

177. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, M. Wagner, M. Krieg, R. Stöckmann, H. Derendorf A PK/PD approach to predict the cumulative cortisol suppression of inhaled corticosteroids J. Biopharm. Pharmacokin. 27, 127-147 (1999).

178. E.U. Graefe, H. Derendorf, M. Veit Pharmacokinetics and bioavailability of the flavonol quercetin in humans Int. J. Clin. Pharmacol. Ther. 37, 209-218 (1999).

179. I. Beierle, B. Meibohm, H. Derendorf Gender differences in pharmacokinetics and pharmacodynamics Int. J. Clin. Pharmacol. Ther. 37, 529-547 (1999).

180. B. Mayer, C. Mensik, S. Krishnaswami, H. Derendorf, H.G. Eichler, L. Schmetterer, M. Wolzt Pharmacokinetic-pharmacodynamic profile of systemic nitric oxide-synthase inhibition with L-NMMA in humans Br. J. Clin. Pharm. 47, 539-544 (1999).

181. B. Meibohm, H. Derendorf, H. Möllmann, P. Froehlich, A. Tromm, M. Wagner, S. Homrighausen, M. Krieg, G. Hochhaus Mechanism based PK/PD –model for the lymphocytopenia induced by endogenous and exogenous corticosteroids Int. J. Clin. Pharmacol. Ther. 37, 367-376 (1999).

182. H. Derendorf, B. Meibohm Modeling of pharmacokinetic/pharmacokinetic (PK/PD) relationships: Concepts and perspectives Pharm. Res. 16, 176-185 (1999).

183. C. Rojas, N.V. Nagaraja, H. Derendorf In vitro recovery of triamcinolone acetonide in microdialysis Pharmazie 55, 659-662 (2000).

184. D.H. Schweitzer, P.P.H. LeBrun, S. Krishnaswami, H. Derendorf Pharmacodynamic effects of an accidental triamcinolone acetonide overdose – a case study Neth. J. Med. 56, 12-16 (2000).

185. M. Schwahn, N.V. Nagaraja, H. Derendorf Population pharmacokinetic modeling of cetrorelix, a novel LH-RH antagonist, and testosterone in rats and dogs Pharm. Res. 17, 328-335 (2000).

186. B. Pechstein, N.V. Nagaraja, R. Hermann, P. Romeis, M. Locher, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of testosterone and luteinizing hormone suppression by cetrorelix in healthy volunteers J. Clin. Pharmacol. 40, 266-274 (2000).

187. A. de la Peña, A. Gräbe, H. Derendorf Pharmacokinetics of beta-lactamase inhibitors in renal impairment (in German) Chemotherapy J. 9, 107-113 (2000).

188. S. Delacher, H. Derendorf, U. Hollenstein, M. Brunner, C. Joukhadar, S. Hofmann, A. Georgopoulos, H.G. Eichler, M. Müller A combined in vivo pharmacokinetic–in vitro pharmacodynamic approach to simulate target site pharmacodynamics of antibiotics in humans J. Antimicrob. Chemother. 46, 733-739 (2000).

189. H. Derendorf, L. Lesko, P. Chaikin, W.A. Colburn, P. Lee, R. Miller, R. Powell, G. Rhodes, D. Stanski, J. Venitz Pharmacokinetic/pharmacodynamic modeling in drug research and development J. Clin. Pharmacol. 40, 1399-1418 (2000).

190. H. Derendorf, G. Hochhaus, S. Krishnaswami, B. Meibohm, H. Möllmann Optimized therapeutic ratio of inhaled corticosteroids using retrometabolism Pharmazie 55, 223-227 (2000).

191. S. Krishnaswami, H. Möllmann, H. Derendorf, G. Hochhaus A sensitive LC-MS/MS method for the quantification of fluticasone propionate in human plasma J. Pharm. Biomed. Anal. 22, 123-129 (2000).

192. N.V. Nagaraja, Y.J. Park, S. Jeon, C.D. Sands, H. Derendorf Population pharmacokinetics of digoxin in Korean patients Int. J. Clin. Pharmacol. Ther. 38, 291-297 (2000).

193. A. de la Peña, P. Liu, H. Derendorf Microdialysis in peripheral tissues Adv. Drug Deliv. Rev. 45, 189-216 (2000).

194. G. Hochhaus, J. Barrett, H. Derendorf Evolution of pharmacokinetics and pharmacokinetic/dynamic correlations during the 20th century J. Clin. Pharmacol. 40, 908-917 (2000).

195. S. Krishnaswami, G. Hochhaus, H. Derendorf An interactive algorithm for the assessment of cumulative cortisol suppression during inhaled corticosteroid therapy AAPS Pharmsci. (http://www.pharmsci.org) 2(3), article 22 (2000).

196. B. Meibohm, H. Derendorf Pharmacokinetics and pharmacodynamics of biotechnological drugs (in German) In “Pharmazeutische Biotechnologie“, edited by O. Kayser and R.H. Müller, Wissenschaftliche Verlagsgesellschaft Stuttgart, p. 103-124 (2000).

197. N.V. Nagaraja, B. Pechstein, K. Erb, C. Klipping, R. Hermann, G. Niebch, H. Derendorf PK/PD modeling of cetrorelix, a LH-RH anatgonist, after subcutaneous administration in healthy postmenopausal women Clin. Pharm. Ther. 68,617-625 (2000).

198. A. Kovar, T. Peters, N. Beier, H. Derendorf Pharmacokinetic/pharmacodynamic evaluation of eniporide J. Clin. Pharmacol. 41, 139-148 (2001).

199. G. Hochhaus, J. Barth, S. Al-Fayoumi, S. Suarez, H. Derendorf, H. Möllmann Pharmacokinetics and pharmacodynamics of dexamethasone sodium-m-sulfobenzoate (DS) after intravenous and intramuscular administration: A comparison with dexamethasone phosphate (DP) J. Clin. Pharmacol. 41, 425-434 (2001).

200. H. Derendorf, G. Hochhaus, H. Möllmann Evaluation of pulmonary absorption using pharmacokinetic methods J. Aerosol Med. 14, S9-S17 (2001).

201. S. Krishna, N.V. Nagaraja, T. Planche, T. Agbenyega, G. Bedo-Addo, D. Ansong, A. Owusu-Ofori, A. Shroads, G. Henderson, A. Hutson, H. Derendorf, P. Stacpoole Population pharmacokinetics of intramuscular quinine in children with severe malaria Antimicrob. Agents Chemother. 45, 1803-1809 (2001).

202. H. Möllmann, M. Wagner, S. Krishnaswami, H. Dimova, Y. Tang, C. Falcoz, P. Daley-Yates, M. Krieg, R. Stöckmann, J. Barth, C. Lawlor, A. Möllmann, H. Derendorf, G. Hochhaus Single-dose and steady-state pharmacokinetic and pharmacodynamic evaluation of therapeutically clinically equivalent doses of inhaled fluticasone propionate and budesonide, given as Diskus or Turbohaler dry-powder J. Clin. Pharmacol. 41, 1329-1338 (2001).

203. H. Derendorf, P.T. Daley-Yates, J. Efthimiou Systemic bioavailability of inhaled steroids: The importance of appropriate and comparable methodology Eur. Resp. J. 17, 157-158 (2001).

204. E.U. Gräfe, J. Wittig, S. Müller, A.K. Riethling, B. Uehleke, B. Drewelow, H. Pforte, G. Jacobasch, H. Derendorf, M. Veit Pharmacokinetics and bioavailability of quercetin glycosides in humans J. Clin. Pharmacol. 41, 492-499 (2001).

205. A. Tromm, H. Möllmann, J. Barth, G. Hochhaus, M. Krieg, C. Bigalke, A. Möllmann, H. Derendorf Pharmacokinetics and rectal bioavailability of hydrocortisone acetate after single and multiple administration in healthy subjects and patients J. Clin. Pharmacol. 41, 536-541 (2001).

206. C. Joukhadar, H. Derendorf, M. Müller Microdialysis - a novel tool for clinical studies of antiinfective agents Eur. J. Clin. Pharmacol. 57, 211-219 (2001).

207. M. Müller, U. Müller-Zellenberg, G. Hochhaus, H. Derendorf Current concepts in pharmacokinetics and their implications for clinical medicine Wien. Klin. Wochenschr. 15/16, 566-572 (2001).

208. A. de la Peña, T. Dalla Costa, J.D. Talton, E. Rehak, J. Gross, U. Thyroff-Friesinger, A.I. Webb, M. Müller, H. Derendorf Penetration of cefaclor into the interstitial space fluid of skleletal muscle and lung tissue in rats Pharm. Res. 18, 1310-1314 (2001).

209. H. Derendorf, S. Krishnaswami, G. Hochhaus, H. Möllmann Systemic disposition and effects of inhaled corticosteroids In „Airway activity and selectivity of inhaled steroids in asthma‟, ed. by R. Schleimer, P. O‟Byrne, S. Szefler, R. Brattsand, Dekker, Lung biology in health and disease, Vol. 163, pg. 247-272 (2001).

210. G. Hochhaus, H. Derendorf, J. Talton, H. Möllmann Factors involved in the pulmonary targeting of inhaled glucocorticoids In „Airway activity and selectivity of inhaled steroids in asthma‟, ed. by R. Schleimer, P. O‟Byrne, S. Szefler, R. Brattsand, Dekker, Lung biology in health and disease, Vol. 163, pg. 283-307 (2001).

211. B. Meibohm, H. Derendorf Pharmacokinetic/pharmacodynamic studies in drug product development J. Pharm. Sci. 91, 18-31 (2002).

212. H. Derendorf, P.T. Daley-Yates, L.N. Pierre, J. Efthimiou Bioavailability and metabolism of mometasone furoate - pharmacology versus methodology J. Clin. Pharmacol. 42, 383-387 (2002).

213. A. de la Peña, M. Brunner, H.-G. Eichler, E. Rehak, J. Gross, U. Thyroff-Friesinger, M. Müller, H. Derendorf Comparative target site pharmacokinetics of immediate and modified-release formulations of cefaclor in humans J. Clin. Pharmacol. 42, 403-411 (2002).

214. G. Hochhaus, S. Sahasranaman, H. Derendorf, H. Möllmann Intranasal glucocorticoid delivery: competition between local and systemic effects S.T.P. Pharma Sciences 12, 23-31 (2002).

215. A. Buchwald, H. Derendorf, F. Ji, N.V. Nagaraja, M.W. Wu, N. Bodor Soft cannabinoid analogues as potential anti-glaucoma agents Pharmazie 57, 108-114 (2002).

216. P. Liu, M. Müller, M. Grant, A. Webb, B. Obermann, H. Derendorf Interstitial tissue concentration of cefpodoxime J. Antimicrob. Chemother. 50, 19-22 (2002).

217. B. Meibohm, I. Beierle, H. Derendorf How important are gender differences in pharmacokinetics Clin. Pharmacokinet. 41, 329-342 (2002).

218. P. Liu, M. Müller, H. Derendorf Rational dosing of antibiotics: the use of plasma concentrations versus tissue concentrations Int. J. Antimicrob. Agents 19, 285-290 (2002).

219. J.W. Mouton, M.N. Dudley, O. Cars, H. Derendorf, G.L. Drusano Standardization of pharmacokinetic/pharmacodynamic (PK/PD) terminology for anti-infective drugs Int. J. Antimicrob. Agents 19, 355-358 (2002).

220. C. Kohlert, G. Schindler, R.W. März, G. Abel, B. Brinkhaus, H. Derendorf, E.U. Gräfe, M. Veit Systemic availability and pharmacokinetics of thymol in humans J. Clin. Pharmacol. 42, 731-737 (2002).

221. V.A. Bhattaram, E.U. Gräfe, C. Kohlert, M. Veit, H. Derendorf Pharmacokinetics and bioavailability of herbal medicinal products Phytomedicine 9 (Suppl. III), 1-36 (2002).

222. E.S. El Desoky, N.V. Nagaraja, H. Derendorf Population pharmacokinetics of digoxin in Egyptian pediatric patients: Impact of one data point utilization Am. J. Ther. 9, 492-498 (2002).

223. K. Erb, K. Junge, B. Pechstein, E. Schneider, H. Derendorf, R. Hermann Novel formulations of cetrorelix acetate in healthy men: Pharmacodynamic effects and noncompartmental pharmacokinetics J. Clin. Pharmacol. 42, 995-1001 (2002).

224. C. Rojas, N.V. Nagaraja, A.I. Webb, H. Derendorf Microdialysis of triamcinolone acetonide in rat muscle J. Pharm. Sci. 92, 394-397 (2003).

225. N.V. Nagaraja, B. Pechstein, K. Erb, C. Klipping, R. Hermann, M. Locher, H. Derendorf Pharmacokinetic/pharmacodynamic modeling of Luteinizing Hormone (LH) suppression and LH surge delay by cetrorelix after single and multiple doses in healthy premenopausal women J. Clin. Pharmacol. 43, 243-251 (2003).

226. A.M. Persky, M. Müller, H. Derendorf, M. Grant, G.A. Brazeau, G. Hochhaus Single- and multiple-dose pharmacokinetics of oral creatine J. Clin. Pharmacol. 43, 29-37 (2003).

227. H. Sourgens, J. Schmidt, H. Derendorf Comparison of talinolol and atenolol effects on blood presure in relation to lipid and glucose metabolic parameters. Results from the TALIP study Int. J. Clin. Pharmacol. Ther. 41, 22-29 (2003).

228. T. Agbenyega, T. Planche, G. Bedu-Addo, D. Ansong, A. Owusu-Ofori, V.A. Bhattaram, N.V. Nagaraja, A.L. Shroads, G.N. Henderson, A.D. Hutson, H. Derendorf, S. Krishna, P.W. Stacpoole Population kinetics, efficacy, and safety of dichloroacetate for lactic acidosis due to severe malaria in children J. Clin. Pharmacol. 43, 386-396 (2003).

229. B. Meibohm, H. Derendorf Pharmacokinetics and pharmacodynamics of biotechnology products (in Polish) In “Biotechnologia Farmaceutyczna“, edited by O. Kayser and R.H. Müller, Wydawnictwo Lekarskie PZWL Warszawa, p. 91-110 (2003).

230. D.B. Allen, L. Bielrory, H. Derendorf, R. Dluhy, G.L. Colice, S.J. Szefler Inhaled corticosteroids: Past lessons and future issues Journal Allergy Clin. Immunol. 112, S1-40 (2003).

231. A.M. Persky, N.D. Eddington, H. Derendorf A review of the effects of chronic exercise and physical fitness level on resting pharmacokinetics Int. J. Clin. Pharmacol. Ther. 41, 504-516 (2003).

232. P. Liu, H. Derendorf Antimicrobial tissue concentrations Infect. Dis. Clin. N. Am. 17, 599-613 (2003).

233. S. Rohatagi, S. Appajoyula, H. Derendorf, S. Szefler, R. Nave, K. Zech, D. Banerji Risk-benefit value of inhaled glucocorticoids: a pharmacokinetic/pharmacodynamic perspective J. Clin. Pharmacol. 44, 37-47 (2004).

234. A. de la Peña, A. Gräbe, K. Rand, E. Rehak, J. Gross, U. Thyroff-Friesinger, M. Müller, H. Derendorf PK-PD modeling of the effect of cefaclor on four different bacterial strains Int. J. Antimicrob. Agents 24, 218-225 (2004)

235. B. Meibohm, H. Derendorf Pharmacokinetics and pharmacodynamics of biotech drugs In “Pharmaceutical Biotechnology‟,edited by O. Kayser and R.H. Müller, Wiley-VCH, Weinheim, p. 147-172 (2004).

236. M. Müller, A. de la Pena, H. Derendorf Issues in parmacokinetics and parmacodynamics of anti- infective agents: Kill curves versus MIC Antimicrob. Agents Chemother. 48, 369-377 (2004).

237. R. Hermann, M. Locher, M. Siebert-Weigel, N.LaVallee, H. Derendorf, G. Hochhaus Intranasal loteprednol etabonate in healthy male subjects: Pharmacokinetics and effects on endogenous cortisol J. Clin. Pharmacol. 44, 510-519 (2004).

238. Q. Liu, K. Rand, H. Derendorf Impact of tazobactam pharmacokinetics on the antimicrobial effect of piperacillin-tazobactam combinations Int. J. Antimicrob. Agents 23, 494-497 (2004).

239. H. Derendorf Relevant pharmacokinetic parameters for determining efficacy and safety ininhaled corticosteroids Eur. Respir. Rev. 13, 62-65 (2004).

240. A. Graebe, E.L. Schuck, P. Lensing, L. Putcha, H. Derendorf Physiological, pharmacokinetic and pharmacodynamic changes in space J. Clin. Pharmacol. 44, 837-853 (2004).

241. M. Müller, A. de la Pena, H. Derendorf Issues in parmacokinetics and parmacodynamics of anti- infective agents: Distribution in tissue Antimicrob. Agents Chemother. 48, 1441-1453 (2004).

242. J. Winkler, G. Hochhaus, H. Derendorf How the lung handles drugs: Pharmacokinetics and pharmacodynamics of inhaled corticosteroids Proc. Am. Thorac. Soc. 1, 356-363 (2004).

243. V.A. Schuck, I. Rinas, H. Derendorf In vitro microdialysis sampling of docetaxel J. Pharm. Biomed. Anal. 36, 807-813 (2004).

244. K. Kim, J.A. Johnson, H. Derendorf Differences in drug pharmacokinetics between East Asians and Caucasians and the role of genetic polymorphisms J. Clin. Pharmacol. 44, 1083-1105 (2004).

245. J. Barth, J. Winkler, R. Schumann, N.V. Nagaraja, R. Madabushi, S. Balbach, H. Derendorf, H. Möllmann, G. Möllenhoff Population pharmacokinetics of methylprednisolone in accident victims with spinal cord injury Int. J. Clin. Pharmacol Ther. 42, 504-511 (2004).

246. V. Butterweck, H. Derendorf, W. Gaus, A. Nahrstedt, V. Schulz, M. Unger Pharmacokinetic herb-drug interactions: Are preventive screenings necessary and appropriate? Planta Med. 70, 784-791 (2004).

247. H. Derendorf, S. Pedersen Choosing an inhaled corticosteroid for once-daily administration in asthma Resp. Dig. 6(2), 1-11 (2004).

248. S.M. Wittemer, M. Ploch, T. Windeck, S.C. Müller, B. Drewelow, H. Derendorf, M. Veit Bioavailability and pharmacokinetics of caffeoylquinic acids and flavonoids after oral administration of Artichoke leaf extracts in humans Phytomedicine 12, 28-38 (2005).

249. V.A. Bhattaram, N.V. Nagaraja, T. Peters, T. Machnig, S. Kroesser, A. Kovar, H. Derendorf Population pharmacokinetics of eniporide and its metabolite in healthy subjects and patients with acute myocardial infarction J. Clin. Pharmacol. 45, 631-639 (2005).

250. S. Krishnaswami, G. Hochhaus, H. Möllmann, H. Derendorf Interpretation of absorption rate data for fluticasone propionate obtained in compartmental pharmacokinetic modeling Int. J. Clin. Pharmacol. Ther. 43, 117-122 (2005).

251. C. Buck, N. Bertram, T. Ackermann, T. Sauerbruch, H. Derendorf, W.D. Paar Pharmacokinetics of piperacillin-tazobactam: intermittent dosing versus continuous infusion Int. J. Antimicrob. Agents 25, 62-67 (2005).

252. O. Burkhardt, J. Majcher-Peszynska, K. Borner, R. Mundkowski, B. Drewelow, H. Derendorf, T. Welte Penetration of ertapenem into different pulmonary compartments of patients undergoing lung surgery J. Clin. Pharmacol. 45, 659-665 (2005).

253. E.L. Schuck, A. Dalhoff, H. Stass, H. Derendorf Pharmacokinetic/pharmacodynamic (PK/PD) evaluation of a once-daily treatment using ciprofloxacin in an extended-release dosage form Infection 33 Suppl. 2, 22-28 (2005).

254. J. Mouton, M.N. Dudley, O. Cars, H. Derendorf. G.L. Drusano Standardization of pharmacokinetic/pharmacodynamic (PK/PD) terminology for antiinfective drugs: An update J. Antimicrob. Chemother. 55, 601-607 (2005).

255. P. Liu, K.H. Rand, B. Obermann, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of antibacterial activity of cefpodoxime and cefixime in in vitro kinetic models Int. J. Antimicrob. Agents 25, 120-129 (2005).

256. P. Liu, R. Fuhrherr, A.I. Webb, B. Obermann, H. Derendorf Tissue penetration of cefpodoxime into the skeletal muscle and lung in rats Eur. J. Pharm. Sci. 25, 439-444 (2005).

257. P. Liu, M. Müller, M. Grant, B. Obermann, H. Derendorf Tissue penetration of cefpodoxime and cefixime in healthy subjects J. Clin. Pharmacol. 45, 564-569 (2005).

258. W.R. Heizmann, H. Derendorf Criteria for comparison of the combinations piperacillin/tazobactam and piperacillin/sulbactam Z Herz- Thorax- Gefäßchir. 19, 89-99 (2005).

259. H. Derendorf, G. Hochhaus What is the best marker for inhaled corticosteroid safety? Allergy Asthma Proceed. 26, 89-94 (2005).

260. E.L. Schuck, M. Grant, H. Derendorf Effect of simulated microgravity on the disposition and tissue penetration of ciprofloxacin in healthy volunteers J. Clin. Pharmacol. 45, 822-831 (2005).

261. H. Derendorf, C.P. Van der Maelen, R.S. Brickel, T.R, MacGregor, W. Eisert Dipyridamole bioavailability in subjects with reduced gastric acidity J. Clin. Pharmacol. 45, 845-850 (2005).

262. R.P.E. Yanong, E.W. Curtis, V.A. Bhattaram, M. Gopalakrishnan, N. Ketabi, N.V. Nagaraja, H. Derendorf Pharmacokinetic studies of florfenicol in Koi Carp and Threespot Gourami Trichogaster trichopterus after oral and intramuscular treatment J. Aquat. Anim. Health 17, 129-137 (2005).

263. E.L. Schuck, H. Derendorf Pharmacokinetic/pharmacodynamic evaluation of anti- infective drugs Expert Rev. Antiinfect. Ther. 3, 361-373 (2005).

264. M. Hübner, G. Hochhaus, H. Derendorf Comparative pharmacology, bioavailability, pharmacokinetics and pharmacodynamics of inhaled glucocorticoids Immunol. Allergy Clin. N. Am. 25, 469-488 (2005).

265. M. Brunner, H. Derendorf, M. Müller Microdialysis for in vivo pharmacokinetic/ pharmacodynamic characterization of anti-infective drugs Curr. Opin. Pharmacol. 5, 1-5 (2005).

266. H. Derendorf Corticosteroid pharmacokinetic/pharmacodynamic parameters and their relationship to safety and efficacy Allergy Asthma Proceed. 26, 327-335 (2005).

267. E. ElDesoky, R. Madabushi, Sel D. Amry, V.A. Bhattaram, H. Derendorf Application of two-point assay of digoxin serum concentration in studying population pharmacokinetics in Egyptian pediatric patients with heart failure: does it make sense? Am. J. Ther. 12, 320-327 (2005).

268. W.V. De Castro, S. Mertens-Talcott, A. Rubner, V. Butterweck, H. Derendorf Variation of flavonoids and furanocoumarins in grapefruit juices: a potential source of variability in grapefruit juice-drug interaction studies J. Agric. Food Chem. 11, 249-255 (2006).

269. E. ElDesoky, H. Derendorf. U. Klotz Variability in response to cardiovascular drugs Curr. Clin. Pharmacol. 1, 35-46 (2006).

270. O. Burkhardt, H. Derendorf, T. Welte Achieving eradication of MRSA colonization in patients. Therapeutic options Med. Monatsschr. Pharm. 29, 17-21 (2006).

271. O. Burkhardt, H. Derendorf, T. Welte New antibiotics for the treatment of MRSA infections Med. Monatsschr. Pharm. 29, 56-62 (2006).

272. S.U. Mertens-Talcott, I. Zadezensky, W.V. De Castro, V. Butterweck, H. Derendorf Drug interactions of grapefruit and other citrus – what have we learned? In Y.W.F. Lam, S.M. Huang, S. Hall (Ed.), Herbal Supplements-Drug Interactions, Marcel Dekker, p.147-190 (2006).

273. R. Madabushi, B. Frank, B. Drewelow, H. Derendorf, V. Butterweck Hyperforin in St. John‟s wort drug interactions Eur. J. Clin. Pharmacokin. 62, 225-233 (2006).

274. J.G. Stark, S. Werner, S. Homrighausen, Y. Tang, M. Krieg, H. Derendorf, H. Möllmann, G. Hochhaus Pharmacokinetic/pharmacodynamic modeling of total lymphocytes and selected subtypes after oral budesonide J. Pharmacokinet. Pharmacodyn. 33, 441-459 (2006).

275. M.J. Salvador, E.O. Ferreira, S.U. Mertens-Talcott, W.V. De Castro, V. Butterweck, H. Derendorf, D.A. Dias Isolation and HPLC quantitative analysis of antioxidant flavonoids from Alternanthera tenella Colla Z. Naturforsch. 61, 19-25 (2006).

276. L.A. Boothby, R. Madabushi, V. Kumar, B.D. Bredland, R.C. Hatton, P.L. Doering, H. Derendorf Extended stability of oxytocin in Ringer‟s Lactate Solution at 4o and 25oC Hospital Pharmacy 41, 437-441 (2006).

277. Y. Li, J. Peris, L. Zhong, H. Derendorf Microdialysis as a tool in local pharmacodynamics AAPS Journal 8, E222-235 (2006).

278. M. Brunner, H. Derendorf Clinical microdialysis: Current applications and potential use in drug development Trends in Analytical Chemistry 25, 674-680 (2006).

279. V. Kumar, R. Madabushi, L.A. Boothby, B.D. Breland, R.C. Hatton, P.L. Doering, H. Derendorf Development and validation of an HPLC method for oxytocin in Ringer‟s lactate and its application in stability analysis J. Liq. Chromatog. Rel. Technol. 29, 2353-2365 (2006).

280. O. Burkhardt, C. Lehmann, R. Madabushi, V. Kumar, H. Derendorf, T. Welte Once-daily tobramycin in cystic fibrosis: better for clinical outcome than thrice-daily tobramycin but more resistant development? J. Antimicrob. Chemother. 58, 822-829 (2006).

281. O. Burkhardt, M. Brunner, S. Schmidt, M. Grant, Y. Tang, H. Derendorf Penetration of ertapenem into skeletal muscle and subcutaneous adipose tissue in healthy volunteers measured by microdialysis J. Antimicrob. Chemother. 58, 632-636 (2006).

282. U. Theuretzbacher, F. Ihle, H. Derendorf Pharmacokinetic/pharmacodynamic profile of voriconazole Clin. Pharmacokin. 45, 649-663 (2006).

283. C.J. Clancy, H. Huang, S. Cheng, H. Derendorf, M.H. Nguyen Characterizing the effects of caspofungin on Candida albicans, Candida parapsilosis, and Candida glabrata isolates by simultaneous time-kill and postantifungal- effect experiments Antimicrob. Agents Chemother. 50, 2569-2572 (2006).

284. V.A. Bhattaram, R. Madabushi, H. Derendorf Role of Food and Drug Administration in drug development in K.C. M. Campbell, Pharmacology and Ototoxicity for Audiologists, Thomson Delmar Learning, Clifton Park NY, pg. 33-45 (2006)

285. V. Butterweck, H. Derendorf Pharmacokinetics of botanical products In Y.W.F. Lam, S.M. Huang, S. Hall (Ed.), Herbal Supplements-Drug Interactions, Marcel Dekker, p.205-244 (2006).

286. S.U. Mertens-Talcott, P. Jilma-Stohlawetz, J. Rios, L. Hingorani, H. Derendorf Absorption, metabolism, and antioxidant effects of pomegranate (Punica granatum L.) polyphenols after ingestion of a standardized extract in healthy human volunteers J. Agric. Food Chem. 54, 8956-8961 (2006).

287. W.V. De Castro, M.A. Pires, C.D. Vianna-Soares, E.A. Nunan, G.A. Pianetti, L.M. Moreira-Campos, S.U. Mertens-Talcott, H. Derendorf The influence of formulation on the dissolution profile of diclofenac sodium tablets Drug Dev. Ind. Pharm. 32, 1103-1109 (2006).

288. O. Burkhardt, H. Derendorf, D. Jäger, V. Kumar, R. Madabushi, K. Rohl, J. Barth Moxifloxacin distribution in the interstitial space of infected decubitus ulcer tissue of patients with spinal cord injury measured by in vivo microdialysis Scand. J. Infect. Dis. 38, 904-908 (2006).

289. E.O. Meltzer, H. Derendorf The systemic safety of inhaled corticosteroid therapy: a focus on ciclesonide Ann Allergy Asthma Immunol. 97, 149-157 (2006).

290. H. Derendorf, R. Nave, A. Drollmann, F. Cerasoli, W. Wurst Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma Eur. Respir. J. 28, 1042-1050 (2006).

291. S.U. Mertens-Talcott, I. Zadezensky, W.V. De Castro, H. Derendorf, V. Butterweck Grapefruit-Drug Interactions: Can Interactions with drugs be avoided? J. Clin. Pharmacol. 46, 1390-1416 (2006).

292. V. Kumar, S. Mostafa, M.W. Kayo, E.P. Goldberg, H. Derendorf HPLC Determination of dexamethasone in human plasma and its application to an in vitro release study from endovascular stents Pharmazie 61, 908-911 (2006).

293. J.A. Manthey, K Myung, S. Mertens-Talcott, H. Derendorf, V. Butterweck, W.W. Widmer The isolation of minor-occuring furanocoumarins in grapefruit and analysis of their inhibition of CYP3A4 and P-glycoprotein transport of talinolol from Caco-2 cells Proc. Fla. State Hort. Soc. 119, 361-366 (2006).

294. O. Burkhardt, V. Kumar, D. Katterwe, J. Majcher- Peszynska, B. Drewelow, H. Derendorf, T. Welte Ertapenem in critically ill patients with early-onset ventilator-associated pneumonia: Pharmacokinetics with special consideration on the free drug concentration J. Antimicrob. Chemother. 59, 277-284 (2007).

295. W. Treyaprasert, S.Schmidt, K.H. Rand, U. Suvanakoot, H.Derendorf Pharmacokinetic/pharmacodynamic modeling of in vitro activity of azithromycin against four different bacterial strains Int. J. Antimicrob. Agents 29, 263-270 (2007).

296. M. Vogt, H. Derendorf, J. Kramer, H.E. Junginger, K.K. Midha, V.P. Shah, S. Stavchansky, J.B. Dressman, D.M. Barends Biowaiver monographs for immediate release solid oral dosage forms: Prednisolone J. Pharm. Sci. 96, 27-37 (2007).

297. O. Burkhardt, H. Derendorf, T. Welte Ertapenem: the new carbapenem 5 years after first FDA licensing for clinical practice Expert Opin Pharmacother. 8, 237-56 (2007).

298. H. Derendorf Clinical trials and dipyridamole formulation selection Cerebrovasc Dis. 23, 72-73 (2007).

299. J. Xu, J. Winkler, H. Derendorf A pharmacokinetic/pharmacodynamic approach to predict total prednisolone concentrations in human plasma J Pharmacokinet. Pharmacodyn. 34, 355-372(2007).

300. H. Derendorf, M. Hübner, B. Drewelow, U. Fuhr, C.H. Gleiter, B. Lemmer, G. Mikus, I. Roots, A. Ziegler, D. Ukena Pharmacokinetics and pharmacodynamics of ciclesonide, Arzneimitteltherapie 25, 89-94 (2007).

301. C.S.Chaurasia, M. Müller, E.D. Bashaw, E. Benfeldt, J. Bolinder, R. Bullock, P.M. Bungay, E.C.M. DeLange, H. Derendorf, W.F. Elmquist, M. Hammarlund-Udenaes, C. Joukhadar, D.L. Kellogg, C.E. Lunte, C.H. Nordstrom, H. Rollema, R.J. Sawchuk, B.W.Y. Cheung, V.P. Shah, L. Stahle, U. Ungerstedt, D.F. Welty, H. Yeo AAPS-FDA workshop white paper: Microdialysis principles, application and regulatory perspectives J. Clin. Pharmacol. 47, 589-603 (2007).

302. H. Derendorf Pharmacokinetic and pharmacodynamic properties of inhaled ciclesonide J. Clin. Pharmacol. 47, 782-789 (2007).

303. S. Schmidt, E. Schuck, V. Kumar, O. Burkhardt, H. Derendorf Integration of pharmacokinetic/pharmacodynamic modeling and simulation in the development of new anti-infective agents – minimum inhibitory concentrations vs. kill curves Expert Opin. Drug Discov. 2, 849-860 (2007).

304. S.U. Mertens-Talcott, W.V. De Castro, J.A. Manthey, H. Derendorf, V. Butterweck Polymethoxylated flavones and other phenolic derivates from Citrus in their inhibitory effects on P- glycoprotein-mediated transport of talinolol in Caco-2 cells J. Agric. Food Chem. 55, 2563-2568 (2007).

305. M. Vogt, H. Derendorf, J. Krämer, H.E. Junginger, K.K. Midha, V.P. Shah, S. Stavchansky, J.B. Dressman, D.M. Barends Biowaiver monographs for immediate release solid oral dosage forms: prednisone J. Pharm. Sci. 96, 1480-1489 (2007).

306. W.V. De Castro, S.U. Mertens-Talcott, H. Derendorf. V. Butterweck Grapefruit juice-drug interactions: Grapefruit juice and its components inhibit P-glycoprotein (ABCB1) mediated transport of talinolol in Caco-2 cells J. Pharm. Sci. 96, 2808-2817 (2007).

307. Y. Li, H. Nguyen, H. Derendorf, S. Cheng, C.J. Clancy Measurement of voriconazole activity against Candida albicans, C. glabrata, and C. parapsilosis isolates using time-kill methods validated by high-performance liquid chromatography Antimicrob. Agents Chemother. 51, 2985-2987 (2007).

308. M. Lobmeyer, S. Schmidt, H. Derendorf Pharmacogenetics and personalized medicine Deutsche Apotheker Zeitung (2007).

309. H. Derendorf, K.S. Estes The significance of optimized formulation for dipyridamole in stroke risk reduction European Neurological Disease 2007 (II), 21-23 (2007).

310. C. Scheerans, H. Derendorf, C. Kloft Proposal for a standardized identification of the mono- exponential terminal phase for orally administered drugs Biopharm. Drug. Dispos. 29, 145-157 (2008).

311. Y. Li, M.H. Nguyen, S. Cheng, S. Schmidt, L. Zhong, H. Derendorf, C.J. Clancy A pharmacokinetic/pharmacodynamic mathematical model accurately describes the activity of voriconazole against Candida spp. in vitro Int. J. Antimicrob. Agents (2008).

312. J.W. Mouton, U. Theuretzbacher, W.A. Craig, P.MM. Tulkens, H. Derendorf, O. Cars Tissue concentrations: Do we ever learn? J Antimicrob Chemother. 61, 235-237 (2008).

313. F.B. Mayr, A.O. Spiel, J.M. Leitner, C. Firbas, T. Kliegel, P. Jilma-Stohlawetz, H. Derendorf, B. Jilma Duffy antigen modifies the chemokine response in human endotoxemia Crit Care Med. 36, 159-165 (2008).

314. S. Schmidt, R. Banks, V. Kumar, K.H. Rand, H. Derendorf Clinical microdialysis in skin and soft tissues: an update. J Clin Pharmacol. 48, 351-364 (2008).

List of Papers Presented at Meetings

1. H. Derendorf, P. Rohdewald Measurement of the analgesic action by subjective and objective parameters. 4th Meeting on the Pain Society of Germany, Austria and Switzerland, Munich, October 1979

2. P. Rohdewald, H. Derendorf, C.E. Elger, O. Knoll Evoked potentials as objective parameters of the analgesic response of weak analgesics. Clinical Applications of Evoked Potentials in Neurology, Lyon, October 1980

3. H. Derendorf, E.R. Garrett HPLC of methadone, its major metabolite and cocaine using a post-column extraction of a fluoresent ion-pair. 31st National Meeting of the American Pharmaceutical Association Academy of Pharmaceutical Sciences, Orlando, November 1981

4. H. Derendorf, E.R. Garrrett Determination of morphine-antagonists in biological fluids using HPLC with electrochemical detection. 3lst National Meeting of the American Pharmaceutical Association Academy of Pharmaceutical Sciences, Orlando, November 1981

5. H. Derendorf, G. Drehsen, P. Rohdewald Relative potency of over-the-counter analgesics estimated by somatosensory evoked potentials. 83rd Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics, Lake Buena Vista, March 1982

6. H. Derendorf, G. Drehsen, P. Rohdewald Drug release, saliva levels and efficacy of weak analgesics. 1st General Conference on Pharmaceutical Sciences, Munich, April 1983

7. P. Rohdewald, H. Möllmann, E.W. Schmidt, G. Drehsen, H. Derendorf Influences of high doses of water-soluble glucocorticoids on the cortisol-level in humans. 1st General Conference on Pharmaceutical Sciences Munich, April 1983

8. H. Derendorf, A.A. El-Koussi, E.R. Garrett Electrochemical determination of erythrocyte partitioning and protein binding of naloxone and naltrexone. 1st General Conference on Pharmaceutical Sciences, Munich, April 1983

9. P. Rohdewald, H. Derendorf, G. Drehsen, C.E. Elger, O. Knoll Attenuation of pain by over-the-counter analgesics. Serturner-Symposium, Paderborn, June 1983

10. H. Derendorf, G. Hochhaus, H. Möllmann, P. Rohdewald Determination of glucocorticoids and their water soluble esters in biological fluids. 35rd National Meeting of the American Pharmaceutical Association Academy of Pharmaceutical Sciences, Miami, November 1983

11. H. Derendorf, G. Drehsen, P. Rohdewald Analgesic activity of antipyrine in humans. 85th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Atlanta, March 1984

12. H. Derendorf, H. Möllmann, P. Rohdewald Pharmacokinetics and pharmacodynamics of methylprednisolone and its hemisuccinate ester. 131st Annual Meeting of the American Pharmaceutical Association, Montreal, May 1984

13. P. Rohdewald, H. Derendorf, H. Möllmann, J. Rehder, E.W. Schmidt Pharmacokinetics of water soluble glucocorticoids. Annual Meeting of the German Pharmaceutical Association, Dusseldorf, September 1984

14. H. Derendorf, R.L. Yost Determination of cephalosporins and their metabolites in biological fluids. 37th National Meeting of the American Pharmaceutical Association Academy of Pharmaceutical Sciences, Philadelphia, October 1984

15. H. Derendorf, H. Möllmann, P. Rohdewald Pharmacokinetics of glucocorticoids following the application of high doses of water soluble glucocorticoids. 7th European Workshop on Inflammation, Capri, April 1985

16. R.L. Yost, H. Derendorf, M.B. Affrime Pharmacokinetics of cefotaxime and its metabolite in normal and morbidly obese subjects. Annual meeting of the American College of Clinical Pharmacy, Orlando, July 1985

17. H. Derendorf, H. Möllmann, P. Rohdewald Pharmacokinetics of high dose glucocorticoids 45th International Congress of Pharmaceutical Sciences of F.I.P., Montreal, September 1985

18. H. Derendorf, M. Kaltenbach Coulometric HPLC analysis of morphine in biological fluids. International Symposium on Drug Analysis, Ottawa, September 1985

19. R. Townsend, J.H. Perrin, H. Derendorf HPLC - Determination of free and conjugated estrogens in tablets. 133rd Annual Meeting of the American Pharmaceutical Association, San Francisco, March 1986

20. H. Derendorf, H. Möllmann, P. Rohdewald, G. Gyselby Pharmacokinetics and pharmacodynamics of glucocorticoid suspensions after intraarticular administration. 133rd Annual Meeting of the American Pharmaceutical Association, San Francisco, March 1986

21. H. Derendorf Pharmacokinetics and pharmacodynamics of high-dose glucocorticoids. 19th Annual Higuchi Research Seminar, Lake Ozark, March 1986

22. H. Derendorf, M. Kaltenbach, G. von der Lippe Coulometric HPLC-analysis of morphine-surrogates in biological fluids. 2nd International Symposium on Drug Analysis, Brussels, May 1986

23. G. Mullersman, V.P. Gotz, W.L. Russell, H. Derendorf In vitro and in vivo interactions between ranitidine and sucralfate. Annual Meeting of the American College of Clinical Pharmacy, Chicago, July 1986

24. G. Mullersman, H. Möllmann, A. Gruner, H. Derendorf Influence of triamcinolone acetate on the pharmacokinetics of diclofenac after i.m. - administration. Meeting of the Austrian and German Pharmaceutical Association, Innsbruck, September 1986

25. G. Mullersman, V. Gotz, H. Derendorf In vitro and in vivo interaction between ranitidine and sucralfate. Meeting of the Austrian and German Pharmaceutical Association, Innsbruck, September 1986

26. G. Mullersman, S. Toufflin, H. Derendorf Coulometric HPLC-Analysis of buprenorphine Meeting of the Austrian and German Pharmaceutical Association, Innsbruck, September 1986

27. M. Butschkau, J.H. Perrin, H. Derendorf HPLC - determination, erythrocyte binding and relative bioavailability of codeine. Meeting of the Austrian and German Pharmaceutical Association, Innsbruck, September 1986

28. H. Derendorf, R. Townsend, K. Embil HPLC - determination of conjugated estrogens. Meeting of the Austrian and German Pharmaceutical Association, Innsbruck, September 1986

29. H. Derendorf, G. Mullersman, M.E. Brewster, K.S. Estes, N.S. Bodor Pharmacokinetics and pharmacodynamics of a brain-specific estradiol chemical delivery system. Meeting of the Austrian and German Pharmaceutical Association, Innsbruck, September 1986

30. H. Derendorf, M. Butschkau, J.H. Perrin HPLC-assay, erythrocyte binding and relative bioavailability of codeine. Annual Meeting of the American Association of Pharmaceutical Scientists, Washington, November 1986

31. G. Mullersman, V. Gotz, H. Derendorf In vitro and in vivo interactions between ranitidine and sucralfate. Annual Meeting of the American Association of Pharmaceutical Scientists, Washington, November 1986

32. G. Mullersman, H. Möllmann, A. Grüner, H. Derendorf Pharmacokinetics of diclofenac after intramuscular administration in combination with triamcinolone acetate. Annual Meeting of the American Association of Pharmaceutical Scientists, Washington, November 1986

33. G. Mullersman, S. Toufflin, H. Derendorf Coulometric HPLC-Analysis of buprenorphine. Annual Meeting of the American Association of Pharmaceutical Scientists, Washington, November 1986

34. S.A. Stout, D. Worthington-White, C.M. Riley, H. Derendorf Comparison of a short term assay and a clonogenic assay for the determination of anticancer drug effects. 88th Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics, Orlando, March 1987

35. H. Derendorf, H. Möllmann, P. Rohdewald Pharmacokinetics and pharmacodynamics of high-dose glucocorticoid esters. 88th Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics, Orlando, March 1987

36. H. Derendorf Pharmacokinetics and pharmacodynamics of a chemical delivery system for estradiol. 20th Annual Higuchi Research Seminar, Lake Ozark, March 1987

37. H. Derendorf Pharmacokinetics of glucocorticoids. Workshop on Glucocorticoids in Rheumatology and Orthopedics, Rottach-Egern, April 1987

38. S. A. Stout, C. M. Riley, H. Derendorf The correlation between the pharmacokinetics of melphalan and the pharmacodynamic response of neuroblastoma cells treated in vitro. 3rd European Congress of Biopharmaceutics and Pharmacokinetics, Freiburg, April 1987

39. H. Derendorf Pharmacokinetic evaluation of cefotaxime in normal and obese subjects. 3rd European Congress of Biopharmaceutics and Pharmacokinetics, Freiburg, April 1987

40. S.A. Stout, C.M. Riley, H. Derendorf In vitro pharmacokinetics and pharmacodynamics of melphalan. Biennial Conference on Chemotherapy of Infectious Diseases and Malignancies, Munich, April 1987

41. H. Derendorf Estimation of free tissue levels for the pharmacokinetic evaluation of antibiotics. Biennial Conference on Chemotherapy of Infectious Diseases and Malignancies, Munich, April 1987

42. H. Derendorf Pharmacokinetic significance of free tissue levels. Interscience Conference on Antimicrobial Agents and Chemotherapy, New York, October 1987

43. H. Derendorf Pharmacokinetic criteria for the evaluation of beta-lactam antibiotics. American Association of Pharmaceutical Scientists Western Regional Meeting, Reno, February 1988

44. H. Derendorf, H. Möllmann, P. Rohdewald Pharmacokinetics and pharmacodynamics of methylprednisolone phosphate and hemisuccinate. 89th Annual Meetings of the American Society of Clinical Pharmacology and Therapeutics, San Diego, March 1988

45. H. Derendorf Estimation of free tissue levels of antibiotics. 21st Annual Higuchi Research Seminar, Lake Ozark, March 1988

46. M.E. Brewster, K.S. Estes, T. Loftsson, G. Mullersman, H. Derendorf, R. Perchalski, N. Bodor Chemical and biological properties of a 2-hydroxy-propyl- -cyclodextrin complex of an estradiol chemical delivery system. 4th International Symposium on Cyclodextrins, Munich, April 1988

47. K.S. Estes, H. Derendorf, M.E. Brewster, N. Bodor Buccal administration of a brain-targeted redox-based chemical delivery system for estradiol in rats. Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1988

48. H. Derendorf, H. Möllmann, P. Rohdewald, C. Möllmann, J. Barth Clinical pharmacodynamics of methylprednisolone phosphate. Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1988

49. J. Barth, A. Fett, M. Pörtner, B.E. Braun, H.W. Möllmann, J. Krämer, P. Rohdewald, H. Derendorf Pharmacokinetics of two glucocorticoid suspensions after epidural administration. Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1988

50. H. Derendorf, K.S. Estes, R. Vistelle, M.E. Brewster, R. Clemmons, N. Bodor Pharmacokinetics of an estradiol chemical delivery system in dogs. Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1988

51. H. Möllmann, P. Rohdewald, J.Barth, C. Möllmann, H. Derendorf Comparison of pharmacokinetic and pharmacodynamic properties of high doses of methylprednisolone prodrugs. Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1988

52. E. Brunt, J. Limberg, H. Derendorf HPLC-assay, protein binding and red blood cell partitioning of fleroxacin. Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1988

53. H. Derendorf, H. Möllmann, P. Rohdewald, D. Stroband Comparison of pharmacokinetic properties of several glucocorticoids after intraarticular administration. Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1988

54. C.J. Betlach, A. Cohen, W. Huang, H. Derendorf, M.A. Gonzalez The multiple dose pharmacokinetics of two 24 hour theophylline tablets in normal subjects. 45th Annual Congress of the American College of Allergy and Immunology, Los Angeles, November 1988

55. H. Möllmann, H. Derendorf, G. Hochhaus, J. Barth Biopharmaceutical and pharmacological aspects of locally and systemically administered glucocorticoids. 4th Annual Meeting of the German Society for Osteology, Göttingen, February 1989

56. H. Möllmann, H. Derendorf, G. Hochhaus, J. Barth Pharmacodynamic and mechanic interactions of locally administered glucocorticoid crystal suspensions. 4th Annual Meeting of the German Society for Osteology, Göttingen, February 1989

57. J. Barth, H. Möllmann, H. Derendorf, G. Hochhaus Pharmacodynamic interactions of systemic glucocorticoid therapy. 4th Annual Meeting of the German Society for Osteology, Göttingen, February 1989

58. H. Derendorf, H. Möllmann, P. Rohdewald, D. Stroband, J. Barth, G. Hochhaus Pharmacokinetic aspects of intraaarticular administration of glucocorticoids. 4th Annual Meeting of the German Society for Osteology, Göttingen, February 1989

59. H. Derendorf Pharmacokinetics and pharmacodynamics of glucocorticoids. 22nd Annual Higuchi Research Seminar, Lake Ozark, March 1989

60. H. Derendorf, J. Limberg, E. Brunt Erythrocyte uptake and protein binding of fleroxacin. 4th European Congress of Clinical Microbiology, Nice, April 1989

61. H. Derendorf, H. Möllmann, P. Rohdewald, C. Möllmann, M. Krieg, S. Tunn, J. Barth, H.J. Röthig Clinical pharmacokinetics and pharmacodynamics of methylprednisolone phosphate. 4th World Conference on Clinical Pharmacology and Therapeutics, Mannheim- Heidelberg, July 1989

62. G. Hochhaus, H. Derendorf, H. Möllmann, C. Möllmann, M. Krieg, S. Tunn, J. Barth, H.J. Röthig Comparison of the clinical pharmacodynamics of dexamethasone, methylprednisolone and triamcinolone acetonide. 4th World Conference on Clinical Pharmacology and Therapeutics, Mannheim- Heidelberg, July 1989

63. H. Möllmann, J. Barth, H. Derendorf, G. Hochhaus Time course of bronchospasmolytic effects after injection of different water- soluble glucocorticoids. 4th World Conference on Clinical Pharmacology and Therapeutics, Mannheim- Heidelberg, July 1989

64. F.F.T. Ververs, L Lopez, H.G. Schaefer, S. Freyer, H. Derendorf Simultaneous HPLC-assay of propranolol, diltiazem and diltiazem-metabolites in human plasma with applications. 49th International Congress of Pharmaceutical Sciences of F.I.P., Munich, September 1989

65. H. Derendorf, Y.L. Kan, J. Perrin Effect of lovastatin on the pharmacokinetics of glipizide. 49th International Congress of Pharmaceutical Sciences of F.I.P., Munich, September 1989

66. J. Limberg, J. Sastry, N. Bodor, H. Derendorf Analysis, stability and receptor binding studies on a chemical delivery system for enkephalins. 49th International Congress of Pharmaceutical Sciences of F.I.P., Munich, September 1989

67. K.S. Estes, K. Dietzel, M.E. Brewster, N. Bodor, H. Derendorf Improved bioavailability of dexamethasone administered intravenously as a water soluble cyclodextrin inclusion complex. 49th International Congress of Pharmaceutical Sciences of F.I.P., Munich, September 1989

68. K. Dietzel, V. Keuth, K.S. Estes, M. Brewster, N. Bodor, H. Derendorf Pharmacokinetics of a chemical delivery system for estradiol in dogs. 49th International Congress of Pharmaceutical Sciences of F.I.P., Munich, September 1989

69. H.G. Schaefer, H. Spahn, J. Limberg, H. Derendorf Effects of partial gastrectomy on the pharmacokinetics of propranolol-enantiomers. 49th International Congress of Pharmaceutical Sciences of F.I.P., Munich, September 1989

70. H. Derendorf, H. Möllmann Clinical pharmacokinetics and pharmacodynamics of methylprednisolone phosphate. Annual Meeting of the Southeastern Chapter of the American College of Clinical Pharmacology, Augusta, September 1989.

71. K. Dietzel, K.S. Estes, M.E. Brewster, N.S. Bodor, H. Derendorf Dose linearity testing for a chemical delivery system for estradiol in dogs. Fourth Annual Meeting of the American Association of Pharmaceutical Scientists, Atlanta, October 1989.

72. K. Dietzel, K.S. Estes, M.E. Brewster, N.S. Bodor, H. Derendorf Pharmacokinetics of dexamethasone after intravenous administration of an inclusion complex in ß-hydroxypropylcyclodextrin. Fourth Annual Meeting of the American Association of Pharmaceutical Scientists, Atlanta, October 1989.

73. H. Derendorf, J. Limberg, J. Sastry, N. Bodor Stability and receptor binding of chemical delivery systems for enkephalins. Fourth Annual Meeting of the American Association of Pharmaceutical Scientists, Atlanta, October 1989.

74. H. Derendorf, H.G. Schaefer, J. Limberg, D. Harrison, M.P. Hocking Effects of partial gastrectomy on the pharmacokinetics of propranolol-enantiomers and theophylinne in dogs. Fourth Annual Meeting of the American Association of Pharmaceutical Scientists, Atlanta, October 1989.

75. H. Möllmann, J. Barth, E.W. Schmidt, P. Rohdewald, H. Derendorf, G. Hochhaus Bronchospasmolytic activity of methylprednisolone in patients with severe pulmonary obstruction. Fourth Annual Meeting of the American Association of Pharmaceutical Scientists, Atlanta, October 1989.

76. E.W. Schmidt, B. Rasche, H. Möllmann, J. Barth, W.T. Ulmer, H. Derendorf Plasma-levels of -protease inhibitor, trypsin inhibitor and elastase-inhibitor in patients with lung1 emphysema. Fourth Annual Meeting of the American Association of Pharmaceutical Scientists, Atlanta, October 1989.

77. H. Derendorf Dose optimization based on pharmacokinetic/pharmacodynamic modelling. 23rd Annual Higuchi Research Seminar, Lake Ozark, March 1990.

78. H. Derendorf The role of pharmacokinetics in clinical trials. 7th Symposium on Chemotherapeutics, Munich, March 1990.

79. B. Wichert, H. Derendorf, R.J. Gonzalez-Rothi, H. Schreier Anti-TB drug liposome aerosols: formulation, characterization, stability and uptake by pulmonary alveolar macrophages (AM) in vitro. 36th Annual Congress of the International Association for Pharmaceutical Technology (APV), Kiel, March 1990.

80. H. Derendorf Estimation of free tissue levels as predictors of antibiotic activity. Symposium on Antibiotic Policies, Vienna, March 1990.

81. J. Barth, H. Möllmann, H. Derendorf, G. Hochhaus Pharmacokinetic-pharmacodynamic optimization of systemic glucocorticoid therapy of colitis. Ulmer Symposium on Colitis, Ulm, March 1990.

82. H. Möllmann, J. Barth, H. Derendorf, G. Hochhaus Clinical significance of pharmacokinetics, intrinsic activity and biopharmaceutical properties of glucocorticoids after oral and intravenous administration. Ulmer Symposium on Colitis, Ulm, March 1990.

83. H. Möllmann, J. Barth, D. Hüppe, H. Derendorf, G. Hochhaus Clinical pharmacology of rectally administered glucocorticoids for Crohn's Disease and colitis ulcerosa. Ulmer Symposium on Colitis, Ulm, March 1990.

84. H. Möllmann, J. Barth, S. Tunn, M. Krieg, H. Derendorf, C.R. Möllmann Pharmacokinetics and bioavailability of hydrocortisone after rectal administration of hydrocortisone acetate foam in comparison to oral or intravenous administration of hydrocortisone. Ulmer Symposium on Colitis, Ulm, March 1990.

85. H. Derendorf, H. Möllmann, G. Hochhaus Free peripheral compartment levels as interface between pharmacokinetics and pharmacodynamics of glucocorticoids. 3rd Symposium Frontiers of Pharmacokinetics and Pharmacodynamics, Baltimore, April 1990.

86. H. Derendorf, H. Möllmann, J. Barth, G. Hochhaus Dose optimization of glucocorticoids based on pharmacokinetic-pharmacodynamic modelling. Symposium on Measurement and Kinetics of In Vivo Drug Effects, Noordwijk, June 1990.

87. J. Barth, H. Möllmann, H. Derendorf, C. Möllmann, G. Hochhaus, K.H. Lehr, T. Höhler Systemic absorption of prednicarbate after dermal, oral and pulmonary administration. 11th International Congress of Pharmacology, Amsterdam, July 1990.

88. K.S. Estes, K. Dietzel, M.E. Brewster, G. Ellison, N. Bodor, H. Derendorf The oxidized metabolite of a redox-based chemical delivery system for estradiol is rapidly eliminated in bile and urine of dogs. Gordon Conference on Drug Carriers in Medicine and Biology, Tilton, July 1990.

89. K.S. Estes, K. Dietzel, M.E. Brewster, N. Bodor, H. Derendorf Dexamethasone administered intravenously as a water soluble cyclodextrin inclusion complex. APhA End of Summer Meeting, Arlington, September 1990.

90. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth Dose optimization of corticosteroids. Annual Meeting of the Southeastern Chapter of the American College of Clinical Pharmacology, Johnson City, September 1990.

91. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth Prediction of clinical potency of corticosteroids by pharmacokinetic- pharmacodynamic modelling. Nineteenth Annual Meeting of the American College of Clinical Pharmacology, Las Vegas, November 1990.

92. P. LaBelle, P.D. Ronca, R.V. Zupkis, S. Schwartz, J. Perrin, H. Derendorf, Y.L. Kan The short-term effects of lovastatin on glipizide pharmacokinetics and glycemic control in hypercholesterolemic diabetics. Nineteenth Annual Meeting of the American College of Clinical Pharmacology, Las Vegas, November 1990.

93. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth Area under the effect-time-curve as measure of cumulative drug effects. Fifth Annual Meeting of the American Association of Pharmaceutical Scientists, Las Vegas, November 1990.

94. G. Hochhaus, L.S. Chen, H. Derendorf, P. Druzgala Loteprednol etabonate: Tissue distribution and receptor binding. Fifth Annual Meeting of the American Association of Pharmaceutical Scientists, Las Vegas, November 1990.

95. H.G. Schäfer, S. Freyer, J. Urciola, H. Schmidt, L. Lopez, H. Derendorf Pharmacokinetic interaction of diltiazem and propranolol enantiomers. Fifth Annual Meeting of the American Association of Pharmaceutical Scientists, Las Vegas, November 1990.

96. S.S. Mohamed, H. Derendorf Binding of codeine to healthy and sickle erythrocytes. Fifth Annual Meeting of the American Association of Pharmaceutical Scientists, Las Vegas, November 1990.

97. H. Derendorf, H. Möllmann, J. Barth, S. Tunn, M. Krieg Saliva levels as predictors for free corticosteroid levels in plasma. Fifth Annual Meeting of the American Association of Pharmaceutical Scientists, Las Vegas, November 1990.

98. K.S. Estes, K. Dietzel, M.E. Brewster, G. Ellison, N. Bodor, H. Derendorf Rapid biliary elimination of the oxidized metabolite of a redox-based chemical delivery system for estradiol in dogs. Fifth Annual Meeting of the American Association of Pharmaceutical Scientists, Las Vegas, November 1990.

99. H. Derendorf The role of the pharmacist today and tomorrow. 21st International Pharmaceutical Continuing Education Week, Davos, January 1991.

100. H. Derendorf Pharmacokinetic aspects of drug evaluation. 5th Symposium of the Section Pharmaceutical Chemistry of the German Pharmaceutical Society, Münster, March 1991.

101. H. Derendorf, H. Möllmann, J. Barth Treatment of pulmonary diseases with corticosteroids on the basis of pharmacokinetic-pharmacodynamic relationships. Pulmonology Symposium, Braunschweig, March 1991.

102. H. Derendorf Dose optimization of corticosteroids based on pharmacokinetic-pharmacodynamic modelling. International Workshop on Differential Corticosteroid Therapy of Chronically Inflamed Bowel Diseases, Köln, March 1991.

103. H. Derendorf Twin peaks - stereoselective pharmacokinetics of propranolol. 24th Annual Higuchi Research Seminar, Lake Ozark, March 1991.

104. G. Hochhaus, R. Hochhaus, H. Möllmann, C. Barmeyer, H. Derendorf A sensitive assay for the simultaneous measurement of dexamethasone and dexamethasone-21-isonicotinate. 1991 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Charleston, April 1991.

105. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth Prediction of clinical potency of corticosteroids by pharmacokinetic- pharmacodynamic modelling. 1991 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Charleston, April 1991.

106. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth Area under the effect-time-curve as measure of cumulative drug effects. 1991 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Charleston, April 1991.

107. S. Freyer, L. Lopez, H. Derendorf Pharmacokinetic interaction of diltiazem and propranolol enantiomers. 1991 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Charleston, April 1991.

108. M.L. Kaltenbach, A.P. Mauderli, F. Bauman, B.L. Grundy, H. Derendorf Tooth-pulp evoked potentials in human pain research: Methods and apparatus. 1991 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Charleston, April 1991.

109. S.S. Mohamed, P. Mehta, S. Gross, A. Kedar, M. Ayass, B. Tomlinson, H. Derendorf Pharmacokinetics of codeine in sickle cell patients and healthy controls. 1991 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Charleston, April 1991.

110. K.H. Rand, K. Gibbs, H. Derendorf, J. Graham-Pole Pharmacokinetics of intravenous immunoglobulin in bone marrow transplant patients. Fifth International Conference on Immunopharmacology, Tampa, May 1991.

111. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth Lymphocyte depression as a pharmacodynamic parameter for clinical corticosteroid activity. Fifth International Conference on Immunopharmacology, Tampa, May 1991.

112. H. Derendorf Relevant pharmacokinetic parameters for antibiotics. 17th International Congress of Chemotherapy, Berlin, June 1991.

113. K.S. Estes, M.E. Brewster, H. Derendorf, R.M. Clemmons, N. Bodor Sustained estradiol in CSF with a chemical delivery system. Controlled Release Society, Amsterdam, July 1991.

114. J. Barth, H. Möllmann, S. Tunn, T. Wagner, H. Derendorf, G. Hochhaus Systemic absorption from hydrocortisone acetate rectal foam after single and multiple administration in healthy volunteers and patients with ulcerative colitis 11th Congress of the European Association of Internal Medicine, Lissabon, September 1991

115. H. Derendorf Significance of pharmacokinetic parameters for drug evaluation. First Pharmacy Congress of the South Cone, Gramado, September 1991.

116. H. Derendorf Drug level monitoring in pharmacy practice. First Pharmacy Congress of the South Cone, Gramado, September 1991.

117. H. Möllmann, J. Barth, I. Wagner, S. Tunn, M. Krieg, C. Möllmann, H. Derendorf Pharmacokinetics and rectal bioavailability of hydrocortisone acetate after single and multiple administration. 20th Annual Meeting of the American College of Clinical Pharmacology, Atlanta, October 1991.

118. S. Freyer, L. Lopez, H. Derendorf Pharmacokinetic interaction of diltiazem and propranolol enantiomers. 20th Annual Meeting of the American College of Clinical Pharmacology, Atlanta, October 1991.

119. H. Möllmann, J. Barth, U. Bötel, G. Hochhaus, H. Derendorf, T. Wagner Ultra-high doses of methylprednisolone in acute spinal cord injury: pharmacokinetic considerations. 20th Annual Meeting of the American College of Clinical Pharmacology, Atlanta, October 1991.

120. G. Hochhaus, H. Derendorf, E.W. Schmidt, H. Möllmann Effects versus side-effects: dose optimization based on an integrated pharmacokinetic/dynamic approach. 20th Annual Meeting of the American College of Clinical Pharmacology, Atlanta, October 1991.

121. S.S. Mohamed, P. Mehta, S. Gross, A. Kedar, M. Ayass, B. Tomlinson, H. Derendorf Pharmacokinetics of codeine in sickle cell patients and healthy controls. 20th Annual Meeting of the American College of Clinical Pharmacology, Atlanta, October 1991.

122. H. Derendorf Choice of appropriate pharmacokinetic-pharmacodynamic models for predicting drug effects. First Annual Meeting of the Society for Clinical Pharmacology, Kloster Arnsburg, October 1991.

123. K. Rand, K. Gibbs, H. Derendorf, J. Graham-Pole Pharmacokinetics of intravenous immunoglobulin in bone marrow transplant patients. Sixth Annual Meeting of the American Association of Pharmaceutical Scientists, Washington, November 1991.

124. C.D. Page, M. Mautino, H. Derendorf, J.P. Anhalt Comparative pharmacokinetics of trimethoprim-sulfamethoxazole administered intravenously and orally to captive elephants. Sixth Annual Meeting of the American Association of Pharmaceutical Scientists, Washington, Novemeber 1991.

125. M. Kaltenbach, A. Mauderli, B.L. Grundy, H. Derendorf Tooth-pulp evoked potentials in human pain research: application to the study of the analgesic effect of codeine and ibuprofen. Sixth Annual Meeting of the American Association of Pharmaceutical Scientists, Washington, November 1991.

126. S.S. Mohamed, P. Mehta, S. Gross, A. Kedar, M. Ayass, B. Tomlinson, H. Derendorf Pharmacokinetics of codeine in sickle cell patients and healthy controls. Sixth Annual Meeting of the American Association of Pharmaceutical Scientists, Washington, November 1991.

127. J. Barth, H. Möllmann, J. Armbruster, O.W. Flörke, G. Hochhaus, H. Derendorf Biopharmaceutical characterization of crystals in glucocorticoid suspensions. Sixth Annual Meeting of the American Association of Pharmaceutical Scientists, Washington, November 1991.

128. G. Hochhaus, R. Hochhaus, H. Möllmann, C. Barmeyer, H. Derendorf A sensitive assay for the simultaneous measurement of dexamethasone and dexamethasone-21-isonicotinate. Sixth Annual Meeting of the American Association of Pharmaceutical Scientists, Washington, November 1991.

129. G. Hochhaus H. Derendorf, H. Möllmann, E. Schmidt Is there a dose with an optimal effect/side effect ratio ? Sixth Annual Meeting of the American Association of Pharmaceutical Scientists, Washington, November 1991.

130. J. Barth, H. Möllmann, S. Tunn, T. Wagner, H. Derendorf, G. Hochhaus Systemic absorption from hydrocortisone acetate rectal foam after single and multiple administration in healthy volunteers and patents with ulcerative colitis. 11th Congress of the European Association of Internal Medicine, Lisbon, November 1991.

131. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth Comparative pharmacokinetics and pharmacodynamics of intravenously administered prodrugs for corticosteroids. Japanese-U.S.-Symposium on Drug Delivery, Maui, December 1991.

132 H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf Pulmonary delivery of lipophilic and water-soluble glucocorticoids: pharmacokinetic evaluation. Japanese-U.S.-Symposium on Drug Delivery, Maui, December 1991.

133. J. Barth, H. Möllmann, H. Derendorf, G. Hochhaus Glucocorticoid suspensions for sustained release delivery in orthopedics and rheumatology: factors modulating bioavailability Japanese-U.S.-Symposium on Drug Delivery, Maui, December 1991.

134. H. Möllmann, U. Bötel, J. Barth, C. Möllmann, G. Hochhaus, H. Derendorf Acute treatment of spinal trauma. Symposium on Treatment of Spinal Cord Injuries, Erfurt, March 1992.

135. H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf, E. van Winden Pharmacokinetic/dynamic investigations during therapeutic use of mega-dose methylprednisolone in patients with acute spinal trauma. International Workshop on Neurological Recovery after Spinal Cord Injuries, Heidelberg, March 1992.

136. H. Derendorf Hard-linked pharmacokinetic-pharmacodynamic models. 25th Annual Higuchi Research Seminar, Lake Ozark, March 1992

137. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth Receptor based pharmacokinetic-pharmacodynamic model for corticosteroids. Ninety-third Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Orlando, March 1992.

138. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth Comparative pharmacokinetics and pharmacodynamics of intravenously administered prodrugs for corticosteroids. 1992 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Wilmington, April 1992.

139. H. Derendorf, H. Möllmann, J. Barth, S. Tunn, M. Krieg Saliva levels as predictors for free corticosteroid levels in plasma. 1992 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Wilmington, April 1992.

140. K. Rand, H. Derendorf, K. Gibbs, J. Graham-Pole Pharmacokinetics of intravenous immunoglobulin in bone marrow transplant patients. 1992 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Wilmington, April 1992.

141. C.D. Page, M. Mautino, H. Derendorf, J.P. Anhalt Comparative pharmacokinetics of trimethoprim-sulfamethoxazole administered intravenously and orally to captive elephants. 1992 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Wilmington, April 1992.

142. H. Möllmann, J. Barth, I. Wagner, S. Tunn, M. Krieg, C. Möllmann, H. Derendorf Pharmacokinetics and rectal bioavailability of hydrocortisone acetate after single and multiple administration to healthy volunteers and patients. 1992 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Wilmington, April 1992.

143. S. Balbach, H. Möllmann, U. Boetel, J. Barth, T. Wagner, G. Hochhaus, E. van Winden, H. Derendorf CSF/plasma concentrations of methylprednisolone after ultra-high doses in acute spinal cord injury. 1992 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Wilmington, April 1992.

144. A. Nolting, J. Limberg, M. Lebel, H. Derendorf Free tissue levels as predictors of antibiotic activity 1992 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Wilmington, April 1992.

145. S.S. Mohamed, P. Mehta, S. Gross, A. Kedar, M. Ayass, B. Tomlinson, H. Derendorf Pharmacokinetics of codeine in sickle cell patients and healthy controls. 1992 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Wilmington, April 1992.

146. K.S. Estes, M.E. Brewster, H. Derendorf, R.M. Clemmons, N. Bodor A chemical delivery system (CDS) enhances estradiol (E2) in CSF vs. plasma 1992 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Wilmington, April 1992.

147. J. Barth, H. Möllmann, H. Derendorf, G. Hochhaus Morphological properties, pharmacokinetics and local availability of intraarticularly administered glucocorticoid crystal suspensions. 98th Conference of the German Society of Internal Medicine, Wiesbaden, April 1992.

148. K. McNicol, M. Ausborn, H. Derendorf, R. Gonzalez-Rothi, D. Soucy, A. Stecenko, H. Schreier Pharmacokinetics of pulmonary delivery of amikacin liposomes and liposome toxicity in sheep. International Conference of the American Lung Association / American Thoracic Society, Miami Beach, May 1992.

149. H. Derendorf Pharmacokinetic/pharmacodynamic consequences of space flight. Twelfth Frontiers of Pharmacology Symposium on Pharmacology Beyond Earth's Boundaries, Houston, May 1992.

150. G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf Molecular pharmacological aspects of glucocorticoid therapy Current Concepts of Glucocorticoid Therapy, Darmstadt, May 1992.

151. H. Möllmann, J. Barth, H. Derendorf, G. Hochhaus Fundamentals of corticosteroid therapy Current Concepts of Glucocorticoid Therapy, Darmstadt, May 1992.

152. H. Derendorf, H. Möllmann, J. Barth, G. Hochhaus Rational dose optimization in corticosteroid therapy Current Concepts of Glucocorticoid Therapy, Darmstadt, May 1992.

153. J. Barth, H. Möllmann, G. Hochhaus, H. Derendorf Pharmacodynamic interaction of corticosteroids with immunological and inflammatory processes Current Concepts of Glucocorticoid Therapy, Darmstadt, May 1992.

154. H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf Comparison of the pharmacokinetics of water- and lipid-soluble corticosteroids in various dosage forms after intrabronchial administration and inhalation Current Concepts of Glucocorticoid Therapy, Darmstadt, May 1992.

155. H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf, E. van Winden, U. Bötel Pharmacokinetic-pharmacodynamic investigations after therapeutic use of mega-high doses of methylprednisolone in patients with acute spinal injury. Current Concepts of Glucocorticoid Therapy, Darmstadt, May 1992.

156. J. Barth, T. Wagner, S. Tunn, A. Tromm, H. Derendorf, M. Krieg, H. Möllmann, G. Hochhaus Bioavailability of hydrocortisone after rectal administration in healthy volunteers Inflammatory Bowel Diseases - Pathophysiology and Therapy, Regensburg, June 1992.

157. T. Wagner, J. Barth, A. Tromm, S. Tunn, M. Krieg, H. Derendorf, H. Möllmann Systemic absorption from hydrocortisone acetate rectal foam after single and multiple administration in healthy volunteers Inflammatory Bowel Diseases - Pathophysiology and Therapy, Regensburg, June 1992.

158. H. Möllmann, J. Barth, A. Tromm, C. Bigalke, T. Wagner, U. Schwegler, S. Tunn, H. Derendorf, M. Krieg, B. May, G. Hochhaus Pharmacokinetics and bioavailability of hydrocortisone after single and multiple rectal administration of hydrocortisone acetate foam in patients with distal chronic and inflammatory bowel diseases in comparison to healthy volunteers Inflammatory Bowel Diseases - Pathophysiology and Therapy, Regensburg, June 1992.

159. H. Derendorf What exactly is "tissue concentration"? 4th Biennial Conference on Chemotherapy of Infectious Diseases and Malignancies, Prague, August 1992.

160. A. Nolting, J. Limberg, M. Lebel, H. Derendorf Free tissue concentrations as predictors of antibiotic activity 4th Biennial Conference on Chemotherapy of Infectious Diseases and Malignancies, Prague, August 1992.

161. K. Rand, H. Derendorf, K. Gibbs, J. Graham-Pole Pharmacokinetics of intravenous immunoglobulin in bone marrow transplant patients 4th Biennial Conference on Chemotherapy of Infectious Diseases and Malignancies, Prague, August 1992.

162. S. Rohatagi, H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf Evaluation of pharmacokinetic interactions between prednisolone and hydrocortisone 21st Annual Meeting of the American College of Clinical Pharmacology, Washington, September 1992.

163. A. Suri, H. Derendorf, R.J.M. Mies, M. Kaltenbach, J. van der Aa, N. Gravenstein Use of a spreadsheet program for the determination of variable infusion rates to produce stepwise changes of morphine steady state levels 21st Annual Meeting of the American College of Clinical Pharmacology, Washington, September 1992.

164. H. Möllmann, M. Damoiseaux, J. Barth, K.H. Brandis, G. Hochhaus, H. Derendorf Pharmacokinetics and pharmacodynamics of prednisolone after intravenous and oral administration 21st Annual Meeting of the American College of Clinical Pharmacology, Washington, September 1992.

165. H. Derendorf Clinical significance of pharmacokinetic-pharmacodynamic models 21st Annual Meeting of the American College of Clinical Pharmacology, Washington, September 1992.

166. K.S. Estes, M. Brewster, H. Derendorf, R.M. Clemmons, N. Bodor A chemical delivery system (CDS) enhances estradiol in CSF vs. plasma of dogs 7th Annual Meeting of the American Association of Pharmaceutical Scientists, San Antonio, November 1992.

167. C. Vivas, L. Panton, M. Gonzalez, D. Lowenthal, J. Graves, H. Derendorf Analysis of propranolol in human plasma by reversed phase liquid chromatography 1993 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Research Triangle Park, April 1993.

168. A. Nolting, H. Derendorf Determination of piperacillin in broth solution by high performance liquid chromatography 1993 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Research Triangle Park, April 1993.

169. S. Rohatagi, H. Möllmann, J. Barth, A. Soldner, G. Hochhaus, H. Derendorf Analysis of hydrocortisone, prednisolone and methylprednisolone in biological fluids using normal phase chromatography 1993 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Research Triangle Park, April 1993.

170. A. Suri, V. Srinivasan, M. Kaltenbach, B. Grundy, H. Derendorf Pharmacodynamic evaluation of codeine using tooth pulp evoked potentials 1993 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Research Triangle Park, April 1993.

171. H. Möllmann, A. Tromm, U. Schwegler, B. May, J. Barth, T. Wagner, H. Derendorf, G. Hochhaus Pharmacokinetics and pharmacodynamics of budesonide after rectal application 9th Annual Meeting of the American Gastroenterological Association, Boston, May 1993.

172. A. Tromm, H. Möllmann, U. Schwegler, B. May, J. Barth, H. Derendorf, G. Hochhaus Pharmacokinetics and pharmacodynamics of budesonide after oral topical administration Pharmacokinetics and pharmacodynamics of budesonide after rectal application 9th Annual Meeting of the American Gastroenterological Association, Boston, May 1993.

173. H. Derendorf The significance of free tissue analysis for the pharmacokinetic evaluation of antibiotics Hungarian Society for Chemotherapy, Debrecen, June 1993.

174. H. Derendorf Prospects for controlled drug delivery systems: Impact on drug therapy Florida Pharmacy Association, Marco Island, July 1993.

175. H. Derendorf, J. Barth, G. Hochhaus, H. Möllmann Kinetic/dynamic interrelationships as basis for rational therapy Conference on Corticosteroids for Inflammatory Bowel Diseases, Strassburg, September 1993.

176. H. Derendorf, H. Möllmann, A. Tromm Optimization of therapy by development of disease-related specific dose regimens Conference on Corticosteroids for Inflammatory Bowel Diseases, Strassburg, September 1993.

177. H.W. Ecker, H. Möllmann, A. Tromm, W. Lindemann, J. Barth, H. Derendorf, G. Hochhaus, B. May Comparison of pharmacodynamic effects of 3 mg budesonide in healthy volunteers and patients with inflammatory bowel disease after ileostomy IV. International Symposium on Chronic Inflammatory Bowel Diseases, Strassburg, September 1993.

178. H. Möllmann, A. Tromm, U. Schwengler, B. May, J. Barth, A. Wagner, S. Tunn, M. Krieg, H. Derendorf, G. Hochhaus Pharmacodynamics of budesonide after rectal application in healthy volunteers: evidence for low systemic side effects IV. International Symposium on Chronic Inflammatory Bowel Diseases, Strassburg, September 1993.

179. H. Möllmann, A. Tromm, J. Barth, S. Tunn, M. Krieg, U. Schwengler, B. May, H. Derendorf, G. Hochhaus Plasma levels of budesonide after multiple oral administration of budesonide in healthy volunteers IV. International Symposium on Chronic Inflammatory Bowel Diseases, Strassburg, September 1993.

180. J. Barth, H. Möllmann, A. Tromm, S. Tunn, M. Krieg, U. Schwengler, B.May, H. Derendorf, G. Hochhaus Systemic effects of orally administered budesonide: comparison of a single and divided dose regimen IV. International Symposium on Chronic Inflammatory Bowel Diseases, Strassburg, September 1993.

181. U. Bötel, E. Gläser, J. Barth, R. Schumann, G. Hochhaus, H. Derendorf, S. Tunn, M. Krieg, C. Möllmann, H. Möllmann Pharmacokinetics and metabolic interactions of ultra-high dosed methylprednisolone in patients with acute spinal cord injury 3rd Scientific Meeting of the Scandinavian Medical Society of Paraplegia, Lahti, September 1993.

182. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth Clinical significance of pharmacokinetic-pharmacodynamic modeling of corticosteroids World Congress of Pharmacy and Pharmaceutical Sciences FIP '93, Tokyo, September 1993.

183. H. Derendorf Pharmacodynamic aspects of oral, buccal and nasal systemic drug delivery FIP Taipei Post-Congress Symposium, Taipei, September 1993.

184. A. Tromm, H. Möllmann, U. Schwengler, B. May, J. Barth, H. Derendorf, G. Hochhaus Orla treatment with budesonide in healthy volunteers: evidence of low systemic side effects 22nd Annual Meeting of the American College of Clinical Pharmacology, Boston, November 1993.

185. H. Möllmann, A. Tromm, U. Schwegler, B. May, J. Barth, T. Wagner, H. Derendorf, G. Hochhaus Pharmacodynamics of budesonide after rectal application in healthy volunteers 22nd Annual Meeting of the American College of Clinical Pharmacology, Boston, November 1993.

186. G. Henderson, P. Whalen, R. Darr, S. Curry, H. Derendorf, T. Baumgatner, P. Stacpoole Development and stability of an oral drug formulation for dichloroacetate and thiamine 8th Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1993.

187. A. Nolting, H. Derendorf, K. Rand An in vitro pharmacokinetic-pharmacodynamic model for piperacillin 8th Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1993.

188. S. Rohatagi, H. Möllmann, J. Barth, A. Soldner, G. Hochhaus, H. Derendorf Pharmacokinetic and pharmacodynamic modeling of multiple dosing regimens of methylprednisolone and prednisolone 8th Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1993.

189. A. Tromm, H. Möllmann, U. Schwengler, B. May, J. Barth, H. Derendorf, G. Hochhaus Oral treatment with budesonide: results of a pharmacodynamic study in healthy volunteers 8th Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1993.

190. A. Suri, V. Srinivasan, M. Kaltenbach, B. Grundy, H. Derendorf Somatosensory evoked potentials for measuring the analgesic effect of codeine 8th Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1993.

191. H. Möllmann, A. Tromm, U. Schwengler, B. May, J. Barth, T. Wagner, H. Derendorf, G. Hochhaus Budesonide enemas and suppositories in healthy volunteers: evidence for low systemic side effects 8th Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1993.

192. J. Barth, G. Hochhaus, H. Derendorf, K.H. Lehr, T. Hoehler, H. Möllmann Pharmacokinetics of prednicarbate in humans after oral, pulmonary and cutaneous administration 8th Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1993.

193. J. Barth, G. Hochhaus, R. Hochhaus, H. Derendorf, H. Möllmann Pharmacokinetics and pharmacodynamics of dexamethasone sulfobenzoate and dexamethasone phosphate 8th Annual Meeting of the American Association of Pharmaceutical Scientists, Orlando, November 1993.

194. L. Williams, L.B. Panton, G.J. Guillen, J.E. Graves, C. Vivas, M. Gonzalez, H. Derendorf, M.L. Pollock, D.T, Lowenthal Effect of aerobic exercise training on propranolol pharmacokinetics in young and elderly adults Ninety-fifth Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, New Orleans, March 1994.

195. L. Panton, D. Lowenthal, G. Guillen, L. Williams, J. Graves, H. Derendorf, L. Garzarella, C. Vivas, M. Pollock Effect of aerobic exercise training on resting hepatic blood flow and propranolol kinetics in young and elderly adults Annual Meeting of the American Geriatrics Society, Los Angeles, March 1994.

196. A. Nolting, T. Dalla Costa, H. Derendorf, K. Rand An in vitro pharmacokinetic-pharmacodynamic model for piperacillin 1994 AAPS Southeast Regional Meeting, Durham, April 1994

197. S. Rohatagi, G. Hochhaus, H. Derendorf Pharmacokinetic and pharmacodynamic modeling of triamcinolone acetonide after intravenous, oral and pulmonary administration 1994 AAPS Southeast Regional Meeting, Durham, April 1994

198. E. Galia, S. Rohatagi, G. Hochhaus, H. Derendorf Hydrocortisone suppression after triamcinolone acetonide administration by various routes 1994 AAPS Southeast Regional Meeting, Durham, April 1994

199. S. Rohatagi, G. Hochhaus, H. Derendorf Oral and pulmonary bioavailability of triamcinolone acetonide 1994 AAPS Southeast Regional Meeting, Durham, April 1994

200. S. Rohatagi, E. Galia, G. Hochhaus, H. Derendorf Pharmacokinetic and pharmacodynamic modeling of triamcinolone acetonide after intravenous, oral and pulmonary administration 5th Symposium: Frontiers in Pharmacokinetics and Pharmacodynamics, Baltimore, April 1994.

201. H. Derendorf Pharmacokinetic-pharmacodynamic models Forum on current therapeutic concepts and rational use of corticosteroids for lung and intestinal diseases, Dresden, June 1994.

202. H. Derendorf Pharmacokinetic/pharmacodynamic analysis of corticosteroids - implications for clinical use. International Workshop on Corticosteroids, Göttingen, September 1994.

203. H. Derendorf, G. Hochhaus, S. Rohatagi, J. Barth, H. Möllmann Receptor-based PK/PD model for corticosteroids Second European Congress of Pharmaceutical Sciences, Berlin, September 1994.

204. G. Hochhaus, R. Gonzalez-Rothi, E.W. Schmidt, H. Möllmann, H. Derendorf, T. Dalla Costa, H. Schreier PK/PD characterization of pulmonary targeting Second European Congress of Pharmaceutical Sciences, Berlin, September 1994.

205. G. Hochhaus, P. Froehlich, H. Derendorf, H. Möllmann Selective HPLC/RIA assay for budesonide in biological fluids Second European Congress of Pharmaceutical Sciences, Berlin, September 1994.

206. H. Derendorf Pharmaceutical education in the U.S.A. ABDA Symposium on Pharmaceutical Care, Frankfurt, October 1994.

207. H. Derendorf Influence of systemic delivery on pharmacodynamics 23rd Annual Meeting of the American College of Clinical Pharmacolgy, Orlando, October 1994.

208. A. Suri, M. Kaltenbach, B. Grundy, H. Derendorf Pharmacodynamic evaluation of codeine using tooth pulp evoked potentials 23rd Annual Meeting of the American College of Clinical Pharmacolgy, Orlando, October 1994.

209. A. Nolting, T. Dalla Costa, R. Vistelle, H. Derendorf Free tissue levels of piperacillin, measured by microdialysis, as indicators of antibacterial activity 23rd Annual Meeting of the American College of Clinical Pharmacolgy, Orlando, October 1994.

210. S. Rohatagi, E. Galia, G. Hochhaus, H. Derendorf Influence of endogenous hydrocortisone on pharmacokinetics and pharmacodynamics of exogenous corticosteroids 23rd Annual Meeting of the American College of Clinical Pharmacolgy, Orlando, October 1994.

211. S. Rohatagi, A. Soldner, J. Barth, H. Möllmann, G. Hochhaus, H. Derendorf Pharmacokinetic and pharmacodynamic modelling of oral multiple dosing of methylprednisolone 23rd Annual Meeting of the American College of Clinical Pharmacolgy, Orlando, October 1994.

212. P. Froehlich, H. Derendorf, H. Möllmann, G. Hochhaus A novel method for analysis of budesonide and its metabolites in biological fluids 23rd Annual Meeting of the American College of Clinical Pharmacolgy, Orlando, October 1994.

213. A. Suri, H. Derendorf Determination of ibuprofen enantiomers by reversed phase HPLC using a derivatization technique 9th Annual Meeting of the American Association of Pharmaceutical Scientists, San Diego, November 1994.

214. S. Rohatagi, E. Galia, G. Hochhaus, H. Derendorf Influence of endogenous hydrocortisone on pharmacokinetics and pharmacodynamics of exogenous corticosteroids 9th Annual Meeting of the American Association of Pharmaceutical Scientists, San Diego, November 1994.

215. S. Rohatagi, A. Soldner, J. Barth, H. Möllmann, G. Hochhaus, H. Derendorf Pharmacokinetic and pharmacodynamic modeling of oral multiple dosing of methylprednisolone 9th Annual Meeting of the American Association of Pharmaceutical Scientists, San Diego, November 1994.

216. S. Rohatagi, E. Galia, G. Hochhaus, H. Derendorf Pharmacokinetic and pharmacodynamic modeling of triamcinolone acetonide after intravenous, oral and pulmonary administration 9th Annual Meeting of the American Association of Pharmaceutical Scientists, San Diego, November 1994.

217. A. Nolting, T. Dalla Costa, R. Vistelle, H. Derendorf Free tissue levels of piperacillin measured by microdialysis as indicators of antibacterial activity 9th Annual Meeting of the American Association of Pharmaceutical Scientists, San Diego, November 1994.

218. H. Derendorf Introduction to PK/PD modelling 1st Pharmacokinetic Experts Meeting, Wuppertal, January 1995.

219. H. Derendorf Tissue pharmacokinetics 4th Annual Meeting of the Association for Applied Human Pharmacology, Neuss, January 1995.

220. H. Derendorf Combination of pharmacokinetics and pharmacodynamics 4th Annual Meeting of the Association for Applied Human Pharmacology, Neuss, January 1995.

221. P. Froehlich, H. Derendorf, H. Möllmann, G. Hochhaus A novel method for analysis of budesonide and its metabolites in biological fluids 4th Annual Meeting of the Association for Applied Human Pharmacology, Neuss, January 1995.

222. S. Rohatagi, G. Hochhaus, H. Möllmann, J. Barth, M. Erdmann, H. Sourgens, H. Derendorf Oral and pulmonary bioavailability of triamcinolone acetonide 4th Annual Meeting of the Association for Applied Human Pharmacology, Neuss, January 1995.

223. S. Rohatagi, E. Galia, G. Hochhaus, H. Möllmann, J. Barth, M. Erdmann, H. Sourgens, H. Derendorf Pharmacokinetic and pharmacodynamic modelling of triamcinolone acetonide after intravenous, oral and pulmonary administration 4th Annual Meeting of the Association for Applied Human Pharmacology, Neuss, January 1995.

224. S. Rohatagi, H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf Evaluation of the pharmacokinetic interaction between prednisolone and hydrocortisone 4th Annual Meeting of the Association for Applied Human Pharmacology, Neuss, January 1995.

225. A. Tromm, H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf Plasma levels and pharmacodynamic effects of budesonide tablets and pH-modified- release capsules. Results of a comparative study in healthy volunteers 4th Annual Meeting of the Association for Applied Human Pharmacology, Neuss, January 1995.

226. J. Barth, G. Hochhaus, R. Hochhaus, H. Derendorf, H. Möllmann Pharmacokinetics and pharmacodynamics of the water-soluble dexamethasone-21- sulfobenzoate and dexamethasone phosphate 4th Annual Meeting of the Association for Applied Human Pharmacology, Neuss, January 1995.

227. H. Möllmann, J. Barth, M. Krieg, T. Wagner, H. Derendorf, G. Hochhaus Absorption from hydrocortisone after single and multiple rectal administrations of a hydrocortisone acetate foam preparation 4th Annual Meeting of the Association for Applied Human Pharmacology, Neuss, January 1995.

228. J. Barth, H. Möllmann, H. Derendorf, C. Möllmann, G. Hochhaus, K.H. Lehr, T. Höhler Pharmacokinetics and metabolism of prednicarbate after different routes of administration 4th Annual Meeting of the Association for Applied Human Pharmacology, Neuss, January 1995.

229. A. Möllmann, H. Möllmann, A. Tromm, G. Hochhaus, J. Barth, C. Bigalke, H. Derendorf, B. May Plasma levels and systemic effects after administration of budesonide enemas and foams 4th Annual Meeting of the Association for Applied Human Pharmacology, Neuss, January 1995.

230. J. Barth, H. Möllmann, H. Derendorf, G. Hochhaus Glucocoricoid crystal suspensions for intra-articular administration: crystal morphology, pharmacokinetics and local drug concentrations 4th Annual Meeting of the Association for Applied Human Pharmacology, Neuss, January 1995.

231. H. Derendorf Dose optimization of corticosteroids based on PK/PD-modeling PhRMA Foundation Annual Awardee Meeting, Washington, February 1995.

232. H. Derendorf Dose optimization of anti-infective drugs using microdialysis 28th Annual Higuchi Research Seminar, Lake Ozark, March 1995.

233. H. Derendorf New developments in the field of pharmacokinetics 25 Anos do Curso de Pós-Graduação em Ciências Farmacêuticas da UFRGS, Porto Alegre, March 1995.

234. A. Tromm, H. Möllmann, J. Barth, B. May, G. Hochhaus, H. Derendorf Budesonide plasma levels and quantitative pharmacodynamic effects after oral administartion of pH-modified release tablets and capsules 4th Conference of Gastroenterology, Bonn, March 1995.

235. H. Derendorf Ambulatory intravenous anti-infective therapy Symposium on Effective Antibiotic Therapy, Rostock, June 1995.

236. H. Derendorf Clinical Pharmacokinetics of Antibiotics Symposium on Effective Antibiotic Therapy, Rostock, June 1995.

237. S. Rohatagi, G. Hochhaus, H. Derendorf Correlation of in vitro and in vivo corticosteroid receptor affinity Eastern Regional Meeting of the American Association of Pharmaceutical Scientists, New Brunswick, June 1995.

238. A. Suri, H. Derendorf Pharmacodynamic-pharmacokinetic modeling of the analgesic effect of ibuprofen and flurbiprofen Eastern Regional Meeting of the American Association of Pharmaceutical Scientists, New Brunswick, June 1995.

239. S. Rohatagi, A. Bye, A. Mackie, H. Derendorf Mathematical modeling of cortisol circadian rhythm and cortisol suppression Eastern Regional Meeting of the American Association of Pharmaceutical Scientists, New Brunswick, June 1995.

240. S. Rohatagi, H. Derendorf Correlation of in vitro and in vivo corticosteroid receptor affinity GRASP Meeting, New York, June 1995

241. S. Rohatagi, H. Derendorf Mathematical mndeling of cortisol circadian rhythm and cortisol suppression GRASP Meeting, New York, June 1995

242. T. Dalla Costa, H. Derendorf, A. Nolting, A. Kovar Microdialysis determination of free tissue concentrations of tazobactam and piperacillin administered alone and in combination GRASP Meeting, New York, June 1995

243. S. Suarez, G. Hochhaus, R. Gonzalez-Rothi, A. Lukyanov, H. Derendorf, H. Schreier, T. Dalla Costa Liposomes as a targeted delivery system to the lung GRASP Meeting, New York, June 1995

244. A. Suri, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of the analgesic effect of ibuprofen and flurbiprofen GRASP Meeting, New York, June 1995

245. A. Kovar, T. Dalla Costa, H. Derendorf Determination of plasma and free tissue levels of ceftriaxone in rats using microdialysis Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Morrisville, June 1995

246. T. Dalla Costa, A. Nolting, A. Kovar, H. Derendorf Microdialysis determination of free tissue concentrations of tazobactam and piperacillin administered alone and in combination Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Morrisville, June 1995

247. A. Suri, B.L. Grundy, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of analgesic effects of ibuprofen and flurbiprofen Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Morrisville, June 1995

248. R. Gonzalez-Rothi, S. Suarez, A. Lukyanov, H. Derendorf, H. Schreier, T. Dalla Costa, G. Hochhaus Liposomes as a targeted drug delivery system to the lungs Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Morrisville, June 1995

249. S. Rohatagi, A. Bye, A. Mackie, H. Derendorf Mathematical modeling of cortisol circadian rhythm and cortisol suppression Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Morrisville, June 1995

250. S. Rohatagi, G. Hochhaus, H. Derendorf Optimizing dosing time of systemic corticosteroid administration using PK/PD modeling Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Morrisville, June 1995

251. S. Rohatagi, H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf Receptor based integrated pharmacokinetic modeling of corticosteroids Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Morrisville, June 1995

252. S. Rohatagi, H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf Pharmacokinetics and pharmacodynamics of cloprednol Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Morrisville, June 1995

253. H. Derendorf, A. Nolting, T. Dalla Costa, K. Rand Application of an Emax-model to evaluate the pharmacodynamics of antimicrobials Satellite Symposium on Pharmacodynamics of Antimicrobials, Quebec City, July 1995.

254. A. Suri, B. Grundy, H. Derendorf Intra- and interindividual variability in pharmacokinetics and pharmacodynamics of flurbiprofen and ibuprofen 24th Annual Meeting of the American College of Clinical Pharmacology, Washington, September 1995.

255. S. Rohatagi, Y.L. Kan, H. Derendorf Noncompartmental analysis of pharmacokinetic data after oral and intravenous administration 24th Annual Meeting of the American College of Clinical Pharmacology, Washington, September 1995.

256. S. Rohatagi, U. Täuber, H. Derendorf Pharmacokinetic and pharmacodynamic modeling of cortisol suppression after oral administration of fluocortolone 24th Annual Meeting of the American College of Clinical Pharmacology, Washington, September 1995.

257. T. Dalla Costa, H. Derendorf AUIC - a general target for the optimization of dosing regimens of antibiotics? 24th Annual Meeting of the American College of Clinical Pharmacology, Washington, September 1995.

258. H. Derendorf Pharmacokinetics - today Conference on Safe and Rational Use of Broad-Spectrum Antibiotics, San Francisco, September 1995.

259. R. Gonzalez-Rothi, S. Suarez, A. Lukyanov, H. Derendorf, H. Schreier, T. Dalla Costa, G. Hochhaus Liposomes as a targeted drug delivery system to the lungs 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, November 1995.

260. A. Kovar, T. Dalla Costa, H. Derendorf Determination of plasma and free tissue levels of ceftriaxone in rats using microdialysis 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, November 1995.

261. T. Dalla Costa, A. Nolting, A. Kovar, H. Derendorf Microdialysis determination of free tissue concentrations of tazobactam and piperacillin administered alone and in combination 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, November 1995.

262. S. Rohatagi, A. Bye, A. Mackie, H. Derendorf Mathematical modeling of cortisol circadian rhythm and cortisol suppression 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, November 1995.

263. S. Rohatagi, G. Hochhaus, H. Derendorf Optimizing dosing time of systemic corticosteroid administration using PK/PD modeling 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, November 1995.

264. S. Rohatagi, H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf Receptor based integrated pharmacokinetic and pharmacodynamic modeling of corticosteroids after single and multiple administration 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, November 1995.

265. A. Suri, B.L. Grundy, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of analgesic effect of ibuprofen and flurbiprofen 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, November 1995.

266. S. Rohatagi, H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf Pharmacokinetics and pharmacodynamics of cloprednol 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, November 1995.

267. A. Nolting, T. Dalla Costa, K. Rand, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of the antibacterial effects of piperacillin 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, November 1995.

268. P. Fröehlich, H. Möllmann, H. Derendorf, G. Hochhaus Pharmacokinetic and pharmacodynamic modeling of budesonide after single and multiple oral administration 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, November 1995.

269. H. Derendorf Tissue pharmacokinetics of beta-lactam antibiotics Conference on Comparison of Beta-lactam Antibiotics, Munich, November 1995.

270. H. Derendorf, A. Nolting, T. Dalla Costa, K.Rand Pharmacokinetic-pharmacodynamic modeling of the antibacterial effect of piperacillin in vitro IBC International Conference on Pharmacokinetic/Pharmacodynamic Analysis, Washington, February 1996.

271. G. Hochhaus, S. Suarez, R. Gonzalez-Rothi, H. Derendorf, T. Dalla Costa PK/PD based characterization of pulmonary targeting of glucocorticoids IBC International Conference on Pharmacokinetic/Pharmacodynamic Analysis, Washington, February 1996.

272. S. Rohatagi, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf Disposition and blood cell effects of prednisolone and methylprednisolone 97th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Orlando, March 1996.

273. H. Derendorf, T. Dalla Costa, A. Kovar, A. Nolting Pharmacokinetic aspects of antiinfective therapy 6th Biennial Conference on Antiinfective Agents and Chemotherapy, Leipzig, May 1996.

274. H. Derendorf, A. Kovar Significance of tissue concentrations of macrolides 6th Biennial Conference on Antiinfective Agents and Chemotherapy, Leipzig, May 1996.

275. H. Derendorf Pharmacokinetic-pharmacodynmaic (PK/PD) relationships for antiinfective therapy 6th Biennial Conference on Antiinfective Agents and Chemotherapy, Leipzig, May 1996.

276. T. Dalla Costa, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of piperacillin-tazobactam combinations 6th Biennial Conference on Antiinfective Agents and Chemotherapy, Leipzig, May 1996.

277. A. Kovar, T. Dalla Costa, H. Derendorf Comparison of plasma and free tissue levels of ceftriaxone in rats using microdialysis 6th Biennial Conference on Antiinfective Agents and Chemotherapy, Leipzig, May 1996.

278. H. Derendorf Renal impairment and PK/PD relationships Nephropharmacology 1996, Berlin, June 1996.

279. A. Kovar, T. Dalla Costa, A. Nolting, H. Derendorf Comparison of plasma and free tissue levels of -lactam antibiotics in rats using microdialysis 2nd International Symposium on Infection Models in Antimicrobial Chemotherapy, Reykjavik, July 1996.

280. H. Derendorf, A. Kovar, T. Dalla Costa, A. Nolting, K.H. Rand Comparison of pharmacodynamic models to describe the activity of anti-infective drugs 2nd International Symposium on Infection Models in Antimicrobial Chemotherapy, Reykjavik, July 1996.

281. H. Derendorf, T. Dalla Costa Effect of impaired renal function on the pharmacokinetics of piperacillin, tazobactam and its metabolite VI World Conference on Clinical Pharmacology and Therapeutics, Buenos Aires, August 1996.

282. H. Derendorf, S. Rohatagi, G. Hochhaus, J. Barth, H. Möllmann Receptor-based integrated pharmacokinetic and pharmacodynamic evaluation of corticosteroids VI World Conference on Clinical Pharmacology and Therapeutics, Buenos Aires, August 1996.

283. J. Barth, H. Möllmann, A. Möllmann, M. Krieg, U. Bötel, G. Hochhaus, H. Derendorf Ultra-high dosed methylprednisolone in acute spinal cord injury (SCI) - pharmacokinetics and effects on cortisol, potassium, glucose and blood cells VI World Conference on Clinical Pharmacology and Therapeutics, Buenos Aires, August 1996.

284. T. Dalla Costa, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of piperacillin-tazobactam combinations VI World Conference on Clinical Pharmacology and Therapeutics, Buenos Aires, August 1996.

285. H. Derendorf Pharmacokinetic and pharmacodynamic evaluation of anti-infective agents Workshop on Anti-infective Therapy, German Society of Hospital Pharmacy, Göppingen, September 1996.

286. H. Derendorf Pharmacodynamic aspects of drug absorption 6th Annual Meeting of the German Society for Clinical Pharmacology and Therapeutics, Dresden, September 1996.

287. J. Barth, H. Möllmann, G. Lehr, T. Höhler, H. Derendorf, G. Hochhaus Pharmacokinetics of prednicarbate after dermal, oral and pulmonary administration and monitoring of potential side effects 6th Annual Meeting of the German Society for Clinical Pharmacology and Therapeutics, Dresden, September 1996.

288. G. Hochhaus, R. Gonzalez-Rothi, H. Derendorf, H. Schreier, H. Möllmann Pharmacokinetic/pharmacodynamic relationships relevant for optimizing the effect/risk ratios after topical administration - Pulmonary delivery as an example 6th Annual Meeting of the German Society for Clinical Pharmacology and Therapeutics, Dresden, September 1996.

289. H. Möllmann, G. Hochhaus, A. Tromm, A. Möllmann, H. Derendorf, J. Barth, P. Fröhlich, K.W. Ecker, A. Lindemann, M. Krieg Serum and ileostoma liquid pharmacokinetics and the influence of food after oral administration of pH-modified-release capsules in healthy volunteers and ileostoma patients 6th Annual Meeting of the German Society for Clinical Pharmacology and Therapeutics, Dresden, September 1996.

290. A. Tromm, H. Möllmann, S. v. Heymann, J. Barth, B. May, G. Hochhaus, H. Derendorf Pharmacokinetics and -dynamics after application of budesonide pH-modified-release capsules in patients with Crohn‟s disease and healthy volunteers 6th Annual Meeting of the German Society for Clinical Pharmacology and Therapeutics, Dresden, September 1996.

291. H. Derendorf, A. Kovar, T. Dalla Costa Pharmacokinetic/pharmacodynamic modelling of anti-infective activity Third European Congress of Pharmaceutical Sciences, Edinburgh, September 1996.

292. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf Modulation of lymphocyte count in blood by the circadian rhythm of endogenous cortisol 25th Annual Meeting of the American College of Clinical Pharmacology, Philadelphia, September 1996.

293. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf Cumulative cortisol suppression as a measure of the systemic effect of inhaled corticosteroids 25th Annual Meeting of the American College of Clinical Pharmacology, Philadelphia, September 1996.

294. G. Hochhaus, H. Möllmann, M. Krieg, A. Möllmann, A. Tromm, H. Derendorf, J. Barth Pharmacokinetic/pharmacodynamic evaluation of budesonide after oral delivery 25th Annual Meeting of the American College of Clinical Pharmacology, Philadelphia, September 1996.

295. H. Derendorf PK-PD modeling in drug development 11th Annual Meeting of the American Association of Pharmaceutical Scientists, Seattle, October 1996.

296. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf Circadian rhythm of lymphocytes in blood and its interrelation to endogenous cortisol 11th Annual Meeting of the American Association of Pharmaceutical Scientists, Seattle, October 1996.

297. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf Quantification of cortisol suppression as a measure for the cumulative systemic effect of corticosteroids 11th Annual Meeting of the American Association of Pharmaceutical Scientists, Seattle, October 1996.

298. S. Rohatagi, H. Derendorf Relationship of mean residence time and effective half life after oral and intravenous administration 11th Annual Meeting of the American Association of Pharmaceutical Scientists, Seattle, October 1996.

299. T. Dalla Costa, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of piperacillin-tazobactam combinations 11th Annual Meeting of the American Association of Pharmaceutical Scientists, Seattle, October 1996.

300. H. Derendorf, G. Hochhaus, B. Meibohm, H. Möllmann, J. Barth Pharmacokinetics of inhaled glucocorticoids Workshop on Inhaled Glucocorticosteroids, Brussels, January 1997.

301. H. Derendorf PK/PD modeling of anti-infective drugs: Why MIC is poison for the mind 6th Annual Meeting of the Association for Applied Human Pharmacology, Neu-Ulm, February 1997.

302. H. Derendorf Clinical PK/PD modeling as a tool in drug development of corticosteroids 6th Annual Meeting of the Association for Applied Human Pharmacology, Neu-Ulm, February 1997.

303. H. Derendorf Changes in Pharmacy ABDA Symposium, Königswinter, February 1997.

304. H. Derendorf, G. Hochhaus, B. Meibohm, H. Möllmann, J. Barth Pharmacokinetics and Pharmacodynamics of Inhaled Corticosteroids Landmark Symposium, London, February 1997.

305. B. Meibohm, G. Hochhaus, H. Derendorf Time dependency of the pharmacologic response to glucocorticoids 98th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, San Diego, February 1997.

306. H. Derendorf Pitfalls in tissue pharmacokinetics Thirtieth Annual Higuchi Research Seminar, Lake Ozark, March 1997

307. M. Schwahn, P. Romeis, H. Derendorf, M. Herbst Absolute bioavailability and dose proportionality of cetrorelix, a novel LH-RH- antagonist, in male and female albino Wistar rats Annual Meeting of the German Pharmacological Society, Mainz, March 1997

308. H. Derendorf, G. Hochhaus, B. Meibohm, H. Möllmann, J. Barth Pharmacokinetics and pharmacodynamics of soft corticosteroids for inhalation 1st Drug Optimization via Retrometabolism Conference, Amelia Island, May 1997.

309. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf PK/PD-modeling of the circadian rhythm of the lymphocyte count in blood modulated by endogenous cortisol 1st Drug Optimization via Retrometabolism Conference, Amelia Island, May 1997.

310. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf A PK/PD-approach to assess the systemic activity of inhaled corticosteroids as cumulative cortisol suppression 1st Drug Optimization via Retrometabolism Conference, Amelia Island, May 1997.

311. K.S. Estes, K. Dietzel, M.E. Brewster, N. Bodor, H. Derendorf Rapid renal and biliary elimination of a redox-based chemical delivery system for estradiol in dogs 1st Drug Optimization via Retrometabolism Conference, Amelia Island, May 1997.

312. B. Meibohm, G. Hochhaus, H. Möllmann, J, Barth, H. Derendorf Pharmacokinetic/pharmacodynamic (PK/PD) modeling of inhaled corticosteroids 17th Annual Meeting of the Graduate Research Association of Students in Pharmaceutics, Gainesville, June 1997.

313. E. Liang, H. Derendorf A pitfall in the pharmacokinetics of oral multicompartment analysis 17th Annual Meeting of the Graduate Research Association of Students in Pharmaceutics, Gainesville, June 1997.

314. H. Derendorf Pharmacokinetic and pharmacodynamic properties of inhaled corticosteroids in relation to efficacy and safety Workshop on Targeting Drugs to the Lung, Bagshot, June 1997

315. H. Derendorf Influence of drug absorption and protein binding on drug disposition and pharmacodynamics Residential School on Medicinal Chemistry „Designing Drugs with Optimal In-Vivo Activity After Oral Administration‟, Princeton, July 1997.

316. H. Derendorf Pharmacokinetics in neonates and geriatric patients 1st Uruguyan Congress of Biochemistry, Montevideo, September 1997.

317. S. Rohatagi, G. Hochhaus, A. Kovar, H. Derendorf Algebraic solutions for nonlinear protein binding interactions 26th Annual Meeting of the American College of Clinical Pharmacology, Phoenix, October 1997.

318. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf Advanced PK/PD-model for the modulation of lymphocyte count by glucocorticoids and endogenous cortisol 26th Annual Meeting of the American College of Clinical Pharmacology, Phoenix, October 1997.

319. B. Meibohm, G. Hochhaus, H. Möllmann. J. Barth, H. Derendorf Predictive Power of PK/PD-modeling for inhaled corticosteroids 26th Annual Meeting of the American College of Clinical Pharmacology, Phoenix, October 1997.

320. J. Knoeller, K. Schiffer, H. Derendorf Determination of salbutamol in human plasma using LC/MS/Ms 26th Annual Meeting of the American College of Clinical Pharmacology, Phoenix, October 1997.

321. M. Wagner, G. Hochhaus, R. Stöckmann, H. Derendorf, J. Barth, B. Meibohm, M. Krieg, H. Möllmann Pharmacokinetics and pharmacodynamics after inhaled administration of flunisolide XVI International Congress of Allergology & Clinical Immunology, Cancun, October 1997.

322. H. Möllmann, M. Wagner, R. Stöckmann, H. Derendorf, G. Hochhaus, B. Meibohm, J. Barth, M. Krieg pharmacokinetic/pharmacodynamic evaluation after single-dose inhaled fluticasone propionate XVI International Congress of Allergology & Clinical Immunology, Cancun, October 1997.

323. H, Möllmann, H. Derendorf, J. Barth, B. Meibohm, M. Wagner, M. Krieg, J. Knoeller, A. Möllmann, G. Hochhaus Pharmacokinetic/pharmacodynamic evaluation of systemic effects of flunisolide after inhalation 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November 1997.

324. G. Hochhaus, H. Derendorf, B. Meibohm Pharmacokinetic/pharmacodynamic evaluation of systemic effects of inhaled glucocorticoids 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November 1997.

325. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf Chronopharmacology of cortisol suppression during inhaled corticosteroid therapy 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November 1997.

326. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf Absorption profiles of inhaled corticosteroids 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November 1997.

327. E. Liang, H. Derendorf Pitfalls in pharmacokinetic multi-compartment analysis 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November 1997.

328. S. Rohatagi, H. Derendorf Mathematical description of diurnal cortisol variation using a modified exponential model and characterization of cortisol suppression following corticosteroid administration using an induction model 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November 1997.

329. U. Graefe, H. Derendorf, M. Veit Urinary metabolites of flavonoids in humans after application of a crude extract from Equisetum arvense 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November 1997.

330. D. Gravenstein, A. Suri, J. Koska, H. Derendorf Influence of plasma expansion on plasma protein binding of ketorolac 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November 1997.

331. G. Hochhaus, B. Meibohm, H. Möllmann, H. Derendorf, J. Barth, M. Wagner, M. Krieg, J. Knoeller Pharmacokinetic/pharmacodynamic evaluation of systemic effects of budesonide after oral delivery 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November 1997.

332. H. Derendorf The role of pharmacokinetics and pharmacodynamics in drug discovery and development – future challenges for kineticists and applied mathematicians 1997 Biomedical Kinetics Workshop, Orlando, November 1997.

333. H. Derendorf Pharmacokinetic-pharmacodynamic evaluation of inhalation products Thirty-first Annual Higuchi Research Seminar, Lake Ozark, March 1998

334. H. Derendorf, R. Hermann, P. Romeis, M. Locher, Y. Schnaars, H. Riethmüller- Winzen, B. Pechstein PK-PD modeling of cetrorelix effects on circadian testosterone production 99th Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics, New Orleans, March 1998.

335. B. Meibohm, H. Derendorf, H. Möllmann, M. Wagner, P. Froehlich, G. Hochhaus Physiologically based PK/PD-model for the interaction between endogenous and exogenous corticosteroids and lymphocytes 99th Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics, New Orleans, March 1998.

336. H. Derendorf Local pharmacokinetics of drugs in the lung Respiratory Challenges ‟98, Madrid, March 1998.

337. H. Derendorf, T. Dalla Costa, A. de la Peña Tissue microdialysis of antibiotics 1st International Symposium on Microdialysis in Drug Research and Development, Noordwijkerhout, March 1998.

338. H. Derendorf Pharmacokinetic-pharmacodynamic relationships of antibiotics 2nd European Congress of Chemotherapy, Hamburg, May 1998.

339. H. Derendorf Pharmacists and Physicians – A joint way into the future Meeting of the German Society of Hospital Pharmacists, Hannover, May 1998.

340. H. Derendorf Pharmacokinetics/pharmacodynamics in drug development and drug registration German Drug Regulatory Agency (BfArM), Berlin, May 1998.

341. H. Derendorf, B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, M. Wagner, M. Krieg, R. Stöckmann Pharmacokinetic/pharmacodynamic modeling of cumulative cortisol suppression by inhaled corticosteroids 2nd World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Paris, May 1998.

342. G. Hochhaus, H. Derendorf, B. Meibohm Effect of clearance and volume of distribution on pulmonary targeting of inhaled corticosteroids 3rd International Symposium on Measurements and Kinetics of In Vivo Drug Effects, Noordwijkerhout, May 1998.

343. G. Hochhaus, B. Meibohm, J. Stark, H. Möllmann, H. Derendorf, M. Wagner Interaction between endogenous and exogenous corticosteroids and blood lymphocytes: the buffering capacity of cortisol suppression 3rd International Symposium on Measurements and Kinetics of In Vivo Drug Effects, Noordwijkerhout, May 1998.

344. B. Meibohm, H. Derendorf, H. Möllmann, M. Wagner, G. Hochhaus Mechanism-based PK/PD-model for the interaction between endogenous and exogenous corticosteroids and blood lymphocytes 3rd International Symposium on Measurements and Kinetics of In Vivo Drug Effects, Noordwijkerhout, May 1998.

345. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf Chronopharmacological aspects in cortisol suppression during inhaled corticosteroid therapy 3rd International Symposium on Measurements and Kinetics of In Vivo Drug Effects, Noordwijkerhout, May 1998.

346. A. Nolting, T. Dalla Costa, K. Rand, H. Derendorf Pharmacokinetic-pharmacodynamic model of the antibacterial effects of piperacillin 3rd International Symposium on Measurements and Kinetics of In Vivo Drug Effects, Noordwijkerhout, May 1998.

347. T. Dalla Costa, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of piperacillin-tazobactam combinations 3rd International Symposium on Measurements and Kinetics of In Vivo Drug Effects, Noordwijkerhout, May 1998.

348. H. Derendorf Evaluation and optimization of inhaled corticosteroids Asthma & Allergy Conference, Baltimore, June 1998.

349. H. Derendorf Pharmacokinetics of inhaled corticosteroids Workshop on Asthma and Inflammation, Hamburg, June 1998.

350. H. Derendorf Linked Pharmacokinetic-pharmacodynamic models 4th International Workshop on the Pharmacodynamics of Anticancer Agents, Dunkeld, August 1998.

351. H. Derendorf Pharmacokinetics of second-generation antihistamines 57th Annual Meeting of the American Academy of Otolaryngic Allergy, San Antonio, September 1998.

352. G. Hochhaus, B. Meibohm, A. Tromm, H. Derendorf, J. Stark, J. Barth, H. Möllmann, M. Wagner, M. Krieg, S. Homrighausen, A. Möllmann Interaction between endogenous and exogenous corticosteroids and blood lymphocytes: the buffering capacity of cortisol suppression 27th Annual Meeting of the American College of Clinical Pharmacology, Toronto, October 1998.

353. H. Derendorf Applied pharmacokinetics in intensive care patients German Surgical Society, Frankfurt, October 1998.

354. H. Derendorf Perspectives of Clinical Pharmacy in Research and Practice Annual Meeting of the German Pharmaceutical Society, Tübingen, November 1998.

315. H. Derendorf The role of the pharmacist in the OTC market: A comparison of Germany and the USA 12th Annual Pharmacy Management Conference, Munich, November 1998.

316. H. Derendorf The role of pharmacokinetic-pharmacodynamic modeling in drug development Wolfgang A. Ritschel Symposium, Cincinnati, November 1998.

317. N.V. Nagaraja, B. Pechstein, R. Herrmann, P. Romeis, M. Locher, Y. Schnaars, H. Riethmüller-Winzen, H. Derendorf PK-PD modeling of cetrorelix effects on circadian rhythm of testosterone release 13th Annual Meeting of the American Association of Pharmaceutical Scientists, San Francisco, November 1998.

358. T. Dalla Costa, A. de la Peña, A. Nolting, A. Kovar, H. Derendorf Determination of unbound tissue concentrations of antibiotics by microdialysis 13th Annual Meeting of the American Association of Pharmaceutical Scientists, San Francisco, November 1998.

359. H. Derendorf, A. de la Peña, T. Dalla Costa PK/PD approaches in antibiotic drug evaluation 13th Annual Meeting of the American Association of Pharmaceutical Scientists, San Francisco, November 1998.

360. A. de la Peña, H. Derendorf HPLC method with UV detection for the quantification of cefaclor in biological samples 13th Annual Meeting of the American Association of Pharmaceutical Scientists, San Francisco, November 1998.

361. N.V. Nagaraja, Y.J. Park, H. Cha, C.D. Sands, H. Derendorf Population pharmacokinetics of digoxin in Korean patients 13th Annual Meeting of the American Association of Pharmaceutical Scientists, San Francisco, November 1998.

362. A. de la Peña, T. Dalla Costa, A.I. Webb, H. Derendorf Measurement of unbound tissue concentrations of antibiotics by microdialysis 13th Annual Meeting of the American Association of Pharmaceutical Scientists, San Francisco, November 1998.

363. A. de la Peña, A. Gräbe, M. Cheok, O. Abbas, K.H. Rand, H. Derendorf Instability of cefaclor in different bacterial growth media 13th Annual Meeting of the American Association of Pharmaceutical Scientists, San Francisco, November 1998.

364. S. Krishnaswami, M. Wolzt, C. Mensik, H. Eichler, L. Schmetterer, B. Mayer, H. Derendorf Pharmacokinetic-pharmacodynamic profile of systemic nitric oxide-synthase inhibition by L-NMMA in humans 13th Annual Meeting of the American Association of Pharmaceutical Scientists, San Francisco, November 1998.

365. H. Derendorf Pharmacokinetics and pharmacodynamics of inhaled corticosteroids as basis of rational therapy Pharmaceutical Care – Consultation by Hospital Pharmacists in Clinical Therapy, Hamburg, November 1998.

366. M. Wagner, G. Hochhaus, H. Möllmann, A. Möllmann, M. Krieg, H. Derendorf Duration of pulmonary efficacy after inhalation of fluticasone propionate 171st Annual Meeting of the Society of Internal Medicine, Düsseldorf, November 1998.

367. M. Wagner, M. Kölsch, H. Dimova, A. Möllmann, G. Hochhaus, H. Derendorf, H.D. Tauschel, B. May, A. Tromm, H. Möllmann Rectal administration of budesonide foam: A therapeutic advance? 171st Annual Meeting of the Society of Internal Medicine, Düsseldorf, November 1998.

368. S. Homrighausen, M. Wagner, H. Möllmann, A. Möllmann, J. Barth, M. Krieg, H. Derendorf, A. Tromm, G. Hochhaus Food effect on the pharmacokinetics and systemic effects of a budesonide ph- modified release capsule 171st Annual Meeting of the Society of Internal Medicine, Düsseldorf, November 1998.

369. H. Derendorf PK/PD modeling as a tool in drug development AAPS Indianapolis/Cincinnati Discussion Group, January 1999.

370. H. Derendorf, W. Colburn Accelaration of clinical drug development by the use of PK/PD modeling Annual Meeting of the Society of Applied Human Pharmacology, Heidelberg, February 1999.

371. H. Derendorf Review of current „in vivo‟ dose measurement techniques International Respiratory Forum, London, February 1999.

372. H. Derendorf The expanded role of PK/PD in drug development in the 21st century 100th Annual meeting of the American Society for Clinical Pharmacology and Therapeutics, San Antonio, March 1999.

373. H. Derendorf Pharmacokinetic-pharmacodynamic approach to evaluate antiinfective therapy 9th European Congress of Clinical Microbiology and Infectious Diseases, Berlin, March 1999.

374. H. Derendorf Determination of free tissue levels of antiinfective agents using microdialysis Delaware Valley Drug Metabolism Discussion Group, Philadelphia, April 1999.

375. H. Derendorf, G. Hochhaus, S. Krishnaswami, H. Möllmann Optimized therapeutic ratio of inhaled corticosteroids using retrometabolism 2nd Retrometabolism Based Drug Design and Targeting Conference, Amelia Island, May 1999.

376. H. Derendorf Pharmacokinetics of antihistamines Cleveland Allergy Group, Cleveland, May 1999.

377. H. Derendorf Pharmacokinetic methods of assessing lung deposition 12th International Congress of the International Society for Aerosols in Medicine, Vienna, June 1999.

378. H. Derendorf Pharmacodynamic models to predict anti-infective activity 21st International Congress of Chemotherapy, Brimingham, July 1999.

379. H. Derendorf Correlation of pharmacokinetics and pharmacodynamics 2nd Rostock Antibiotic Days, Rostock, September 1999.

380. H. Derendorf Dose adjustment in impaired renal and hepatic function 2nd Rostock Antibiotic Days, Rostock, September 1999.

381. H. Möllmann, M. Wagner, A. Möllmann, H. Dimova, Y. Tang, A. Tromm, H.D. Tauschel, M. Krieg, H. Weisser, H. Derendorf, G. Hochhaus Pharmacokinetics/pharmacodynamics of budesonide after single and multiple dosing 28th Annual Meeting of the American College of Clinical Pharmacology, Rockville, September 1999.

382. M. Wagner, G. Hochhaus, H. Derendorf, S. Krishnaswami, Y. Tang, A. Möllmann, M. Krieg, H. Möllmann Pharmacokinetics of fluticasone propionate (FP) after single and bidaily inhaled administration over five days 28th Annual Meeting of the American College of Clinical Pharmacology, Rockville, September 1999.

383. H. Derendorf Antimicrobial Therapy Pharmacokinetics/Pharmacodynamics 39th ICAAC, San Francisco, September 1999.

384. H. Derendorf Protein binding: myths and facts 6th International Symposium of the International Society of Anti-Infective Pharmacology, San Francisco, September 1999.

385. E.U. Graefe, J. Wittig, B. Drewelow, A. Riethling, S. Mueller, I. Wukasch, H. Derendorf, M. Veit Relative systemic availability of the flavonoids quercetin and rutin in humans Annual Meeting of the German Pharmaceutical Society, Frankfurt, September 1999.

386. H. Derendorf Evaluation/assessment of anti-infectives in research and practice 28th European Symposium on Clinical Pharmacy, Berlin, October 1999.

387. H. Derendorf Pharmacokinetics of essential fatty acids 1st Conference on The essential Fatty Acid Balance, Miami, Ocotber 1999.

388. S. Werner, J. Stark, H. Möllmann, S. Homrighausen, H. Derendorf, G. Hochhaus, M. Krieg Pharmacokinetics/pharmacodynamic modeling of lymphocyte subpopulations after oral budesonide administration 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November 1999.

389. C. Rojas, N. Nagaraja, H. Derendorf In vitro recovery of triamcinolone acetonide in microdialysis 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November 1999.

390. A. de la Peña, T. Dalla Costa, J.D. Talton, A.I. Webb, E. Rehak, U. Thyroff- Friesinger, H. Derendorf Plasma and tissue concentrations of cefaclor in rats 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November 1999.

391. A. de la Peña, M. Müller, H. Eichler, E. Rehak, U. Thyroff-Friesinger, H. Derendorf Plasma and tissue concentrations of cefaclor in humans 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November 1999.

392. N.V. Nagaraja, B. Pechstein, H. Derendorf A model for suppression of LH and delay in LH surge by cetrorelix in women 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November 1999.

393. N.V. Nagaraja, B. Pechstein, R. Herrmann, P. Romeis, M. Locher, H. Derendorf PK-PD modeling of testosterone and luteinizing hormone supopression by cetrorelix in healthy volunteers 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November 1999.

394. S. Krishnaswami, H. Möllmann, G. Hochhaus, M. Wagner, R. Stöckmann, H. Derendorf Pharmacokinetics of fluticasone propionate after single and multiple inhalations 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November 1999.

395. S. Krishnaswami, H. Möllmann, H. Derendorf. G. Hochhaus Determination of fluticasone propionate in human plasma by liquid chromatography- tandem mass spectrometry 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November 1999.

396. A. Kovar, T. Drave, D.E. de Vries, H. Derendorf Pharmacokinetic/pharmacodynamic evaluation of eniporide 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November 1999.

397. H. Derendorf Value of pharmacodynamic endpoints: Quantifiability, statistical power, and clinical relevance AAPS Workshop on Drug-Drug and Drug-Food Interactions, Arlington, December 1999.

398. H. Derendorf Clinical pharmacokinetics – specific applications in critically ill patients Pharma Hospital 2000 – Rational Drug Therapy in Critically Ill Patients, Sulzbach, February 2000.

399. H. Derendorf, A. de la Peña Pharmacokinetics and pharmacodynamics of betalactam antibiotics in patients with renal impairment 8th Biennial Conference on Antiinfective Agents and Chemotherapy, Munich, March 2000.

400. H. Derendorf, A. de la Peña Determination of active drug levels at the site of infection 8th Biennial Conference on Antiinfective Agents and Chemotherapy, Munich, March 2000.

401. H. Derendorf, P. Liu The clinical relevance of the pharmacokinetic properties of cefpodoxime – a new approach 8th Biennial Conference on Antiinfective Agents and Chemotherapy, Munich, March 2000.

402. H. Derendorf, A. de la Peña Protein binding – myths and facts 8th Biennial Conference on Antiinfective Agents and Chemotherapy, Munich, March 2000.

403. H. Derendorf Pharmacokinetics and systemic exposure of inhaled corticosteroids Inhaled Corticossteroids Relative Potency Workshop, Toronto, May 2000.

404. H. Derendorf The basic concepts of pharmacokinetics 10th European Congress of Clinical Microbiology and Infectious Diseases, Stockholm, May 2000.

405. H. Derendorf General concepts of pharmacodynamics 10th European Congress of Clinical Microbiology and Infectious Diseases, Stockholm, May 2000.

406. H. Derendorf General concepts of PK/PD modeling 10th European Congress of Clinical Microbiology and Infectious Diseases, Stockholm, May 2000.

407. H. Derendorf PK/PD evaluation of antibiotics using microdialysis 2nd International Symposium on Microdialysis in Drug Research and Development, Stockholm, June 2000.

408. A. de la Peña, T. Dalla Costa, J. Talton, P. Liu, A. Webb, H. Derendorf Microdialysis of beta-lactam antibiotics in rat muscle and lung 2nd International Symposium on Microdialysis in Drug Research and Development, Stockholm, June 2000.

409. H. Derendorf Pharmacy Curriculum at the University of Florida 2nd Workshop for Education in Clinical Pharmacy, Bonn, June 2000.

410. H. Derendorf Clinical Pharmacy - a field for all pharmacists Workshop of the Westphalian Chamber of Pharmacy, Münster, June 2000.

411. N.V. Nagaraja, B. Pechstein, K. Erb, M. Locher, R. Hermann, H. Derendorf A PK/PD model for suppression of LH and delay in LH surge by cetrorelix in women VII World Conference on Clinical Pharmacology and Therapeutics, Florence, July 2000.

412. H. Derendorf Pharmacokinetics and drug interactions XVI Latinamerican Congress of Pharmacology, Aguas de Lindoia, September 2000.

413. H. Derendorf The general concepts of pharmacokinetics 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, September 2000.

414. H. Derendorf Microdialysis, protein binding and general concepts of pharmacodynamics 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, September 2000.

415. H. Derendorf General concepts of PK/PD modeling 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, September 2000.

416. M. Kurowski, J. Barrett, E. Waalberg, N.V. Nagaraja, H. Derendorf, H. Wiltshire Oral oseltamivir rapidly delivers active drug levels to middle ear and sinuses in humans 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, September 2000.

417. H. Derendorf The significance of antimicrobial concentrations in extravascular sites 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, September 2000.

418. H. Derendorf Pharmacokinetics vs. pharmacodynamics: Which is more relevant in the 21st century? 29th Annual Meeting of the American College of Clinical Pharmacology, Chicago, September 2000.

419. H. Derendorf Topical and systemic effects after pulmonar administration Annual Meeting of the German Pharmaceutical Association, Münster, October 2000.

420. H. Derendorf Contribution of pharmacokinetics and pharmacodynamics to drug development Annual Meeting of the German Pharmaceutical Association, Münster, October 2000.

421. H. Derendorf Integration of preclinical data into early clinical drug development 2nd Annual Congress for Clinical Pharmacology, Berlin, October 2000.

422. H. Derendorf Pharmacokinetics and bioavailability of phytopharmaceuticals 3rd International Congress on Phytomedicine, Munich, October 2000.

423. S. Krishnaswami, G. Hochhaus, H. Möllmann, M. Wagner, R. Stöckmann, H. Derendorf Pharmacokinetic/pharmacodynamic modeling of inhaled fluticasone propionate 15th Annual Meeting of the American Association of Pharmaceutical Scientists, Indianapolis, November 2000.

424. A. de la Peña, T. Dalla Costa, J.D. Talton, A.I. Webb, M Müller, K. Rand, H. Derendorf Microdialysis and bacterial kill curves as tools in pharmacokinetic/pharmacodynamic modeling of antibiotics 15th Annual Meeting of the American Association of Pharmaceutical Scientists, Indianapolis, November 2000.

425. J.G. Stark, H. Derendorf, H. Möllmann, G. Hochhaus Interplay of endogenous and exogenous corticosteroids and the effects on blood lymphocytes 15th Annual Meeting of the American Association of Pharmaceutical Scientists, Indianapolis, November 2000.

426. H. Derendorf Pharmacokinetics in critical care patients Workshop on Rational Drug Therapy in Critical Care Patients, Frankfurt, November 2000.

427. H. Derendorf Significance of pharmacokinetics and pharmacodynamics for anti-infectious therapy 3rd Workshop on Infections in Neutropenia, Bonn, November 2000.

428. N.V. Nagaraja, B. Pechstein, K. Erb, C. Klipping, R. Hermann, M. Locher, H. Derendorf Pharmacokinetic/pharmacodynamic modeling of LH suppression and LH surge delay by cetrorelix after single and multiple doses in healthy premenopausal women Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Orlando, March 2001.

429. H. Derendorf Optimizing oral delivery: PK and PD Strategies for Oral Drug Delivery, Garmisch-Partenkirchen, March 2001.

430. H. Derendorf PK/PD as a tool in clinical drug development Pharmaceutical Congress of the Americas, Orlando, March 2001.

431. C. Rojas, N.V. Nagaraja, H. Derendorf In vivo recovery of triamcinolone acetonide in microdialysis Pharmaceutical Congress of the Americas, Orlando, March 2001.

432. P.E. Fröehlich, H. Derendorf, G. Hochhaus, B. Meibohm, H. Möllmann Pharmacokinetic/pharmacodynamic modeling of budesonide after oral administration in single and multiple doses Pharmaceutical Congress of the Americas, Orlando, March 2001.

433. J.G. Stark, H. Derendorf, H. Möllmann, G. Hochhaus The influence of administration time on the systemic effects observed during corticosteroid therapy Pharmaceutical Congress of the Americas, Orlando, March 2001.

434. H. Derendorf Can we predict therapeutic failure with pharmacodynamic models? 16th International Course on Chemotherapy, Bratislava, May 2001.

435. H. Derendorf The role of the pharmacist in the new century Pharmacy Strategic Economic Forum, Oberhausen, May 2001.

436. H. Derendorf Basic concepts of pharmacokinetics and pharmacodynamics 33rd Annual Meeting of the German Society for Internal Emergency Medicine, Halle, June 2001.

437. H. Derendorf Interstitial tissue concentrations of cefpodoxime in humans 22nd International Congress of Chemotherapy, Amsterdam, July 2001.

438. H. Derendorf Rational dosing: The use of plasma concentrations versus tissue concentrations ISAP Symposium: Developments in PK/PD: Optimizing Efficacy and Prevention of Resistance, Nijmegen, July 2001.

439. E.S. El Desoky, N.V. Nagaraja, M.S. Abdel-Rahman, S. El Din Amry, H. Derendorf Population pharmacokinetics of digoxin in Egyptian pediatric patients 7th International Congress on Therapeutic Drug Monitoring and Clinical Toxicology, Washington, September 2001.

440. H. Derendorf Innovations in antibiotics therapy 4th Antibiotics Conference, Rostock, September 2001.

441. H. Derendorf Pharmacodynamics in the elderly 16th Annual Meeting of the American Association of Pharmaceutical Scientists, Denver, October 2001.

442. H. Derendorf PK/PD-based development of modified-release dosage forms of established drugs as an alternative to clinical efficacy testing 16th Annual Meeting of the American Association of Pharmaceutical Scientists, Denver, October 2001.

443. H. Derendorf Microdialysis-based PK/PD-approaches in antimicrobial drug development 16th Annual Meeting of the American Association of Pharmaceutical Scientists, Denver, October 2001.

444. A. Buchwald, W. Wu, N.V. Nagaraja, H. Derendorf, N. Bodor The rationale of soft drug design confirmed by pharmacokinetic and pharmacodynamic results on soft-cannabinoid analogs 16th Annual Meeting of the American Association of Pharmaceutical Scientists, Denver, October 2001.

445. J. Kurz, N.V. Nagaraja, S. Balbach, J. Barth, R. Schumann, G. Hochhaus, H. Möllmann, H. Derendorf Population pharmacokinetics of methylprednisolone in patients with acute spinal cord injury 16th Annual Meeting of the American Association of Pharmaceutical Scientists, Denver, October 2001.

446. P. Liu, A. Webb, H. Derendorf Tissue penetration of cefpodoxime measured by microdialysis 16th Annual Meeting of the American Association of Pharmaceutical Scientists, Denver, October 2001.

447. H. Derendorf Pharmacokinetics and pharmacodynamics in the elderly ABDA Symposium Gesünder länger leben, Frankfurt, November 2001.

448. H. Derendorf Collaboration of Clinical Pharmacy and Clinical Pharmacology 3rd Annual Conference of Clinical Pharmacology, Cologne, November 2001.

449. H. Derendorf Microdialysis for PK/PD-studies 3rd Annual Conference of Clinical Pharmacology, Cologne, November 2001.

450. H. Derendorf The general concepts of pharmacokinetics and pharmacodynamics ISAP Workshop at the 41st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, December 2001.

451. H. Derendorf The general concepts of PK/PD modeling ISAP Workshop at the 41st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, December 2001.

452. A. Khunvichai, M. Hirt, M. Karmann, L. Joliff, K. Rand, H. Derendorf A novel indirect response pharmacokinetic/pharmacodynamic model to characterize the effect of faropenem on Streptococcus pneumoniae and Haemophilus influenzae 41st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, December 2001.

453. K. Erb, N.V. Nagaraja, B. Pechstein, C. Klipping, R. Hermann, H. Derendorf PK/PD modeling of hormone effects by cetrorelix Annual Meeting of the Association for Applied Human Pharmacology, Garmisch- Partenkirchen, January 2002.

454. H. Derendorf What constitutes the ideal inhaled corticosteroid? Current Ststus of Inhaled Corticosteroids for Asthma, New York, February 2002.

455. H. Derendorf Optimizing oral drug delivery: Pharmacokinetics and pharmacodynamics Strategies for Oral Drug Delivery, Lake Tahoe, March 2002.

456. H. Derendorf, V.A. Bhattaram, S. Boettcher, J. Dasenbrock, T. Machnig, T. Peters, A. Kovar, N.V. Nagaraja Population pharmacokinetics of eniporide and its emtabolite in healthy volunteers and patients Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Atlanta, March 2002.

457. H. Derendorf PK/PD modelling of anti-Infectives Fourth International Symposium on Measurement and Kinetics of In Vivo Drug Effects, Noordwijkerhout, April 2002.

458. H. Derendorf New aspects for the evaluation of antibiotics Workshop Clinical Pharmacy, Munich, May 2002.

459. H. Derendorf, H. Möllmann Are all steroids alike? Workshop Clinical Pharmacy, Munich, May 2002.

460. H. Derendorf Pharmacokinetics and pharmacodynamics of anti-infective drugs Annual Meeting of the Slovak Society of Chemotherapy, Bratislava, May 2002.

461. H. Derendorf New insights into inhaled corticosteroids 2002 American Thoracic Society Annual Meeting, Atlanta, May 2002.

462. H. Derendorf Integrating preclinical data into the clinical phase of the drug development process AAPS Workshop on Exposure Response Relationships, Arlington, June 2002.

463. S. Rohatagi, H. Derendorf, K. Zech Risk-benefit value of inhaled corticosteroids: A pharmacokinetic/pharmacodynamic perspective 45th Annual Thomas L.Petty Lung Conference, Aspen, June 2002.

464. P. Liu, M. Müller, M. Grant, A.I. Webb, B. Obermann, H. Derendorf Interstitial tissue concentrations of cefpodoxime using microdialysis 3rd International Symposium on Microdialysis in Drug Research & Development, Minneapolis, June 2002.

465. V. Schuck, M. Müller, M. Grant, G. Hochhaus, H. Derendorf Use of microdialysis to evaluate dexamethasone tissue distribution 3rd International Symposium on Microdialysis in Drug Research & Development, Minneapolis, June 2002.

466. H. Derendorf Biomarkers and PK/PD Modeling AAPS NAtional Biotechnology Conference, San Diego, June 2002.

467. R.P.E. Yanong, E.W. Curtis, V.A. Bhattaram, M. Gopalakrishnan, N. Ketabi, N.V. Nagaraja, H. Derendorf, R. Simmons Single-dose pharmacokinetics of florfenicol in Koi (Cyprinus carpio) and Gourami (Trichogaster trichopterus) 4th International Symposium on Aquatic Animal Health, New Orleans, September 2002.

468. H. Derendorf Pharmacokinetic-pharmacodynamic modeling in oncology Meeting of the Austrian Society of Oncology Pharmacy, Vienna, September 2002.

469. P. Liu, M. Müller, M. Grant, K. Rand, H. Derendorf Pharmacokinetics and pharmacodynamics of cefpodoxime and cefixime 31st Annual Meeting of the American College of Clinical Pharmacology, San Francisco, September 2002.

470. V.A. Bhattaram, C. deMey, H. Stammer, C. Beichl, K. Erb, R. Beise, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of ACE inhibition by a modified release captopril formulation based on total and free concentrations 31st Annual Meeting of the American College of Clinical Pharmacology, San Francisco, September 2002.

471. H. Derendorf Pharmacokinetics of beta-lactam inhibitors ICAAC Wyeth Symposium on Therapy of Nosocomial Infections, San Diego, September 2002.

472. H. Derendorf The general concepts of pharmacokinetics and pharmacodynamics ISAP Workshop at the 42nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, September 2002.

473. H. Derendorf The general concepts of PK/PD modeling ISAP Workshop at the 42nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, September 2002.

474. E.L. Schuck, A. Dalhoff, H. Stass, H. Derendorf Pharmacokinetic-pharmacodynamic (PK/PD) evaluation of a once-daily treatment using ciprofloxacin in an extended-release dosge form 42nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, September 2002.

475. H. Derendorf Are all corticosteroids alike? 57th Annual Meeting of the Southeastern Allergy, Asthma and Immunology Society, Sea Island, October 2002.

476. S. Wittemer, M. Ploch, T. Windeck, S. Müller, B. Drewelow, H. Derendorf, M. Veit Bioavailability of caffeoylquinic acids and flavonoids in humans after application of two different artichocke leaf extracts Annual Meeting of the German Pharmaceutical Society, Berlin , October 2002.

477. E.L. Schuck, V.A. Bhattaram, H. Derendorf Antibiotic therapy during space flights: A disaster bound to happen? Use of Monte Carlo Simulations to evaluate 1G recommended dosing regimens of ciprofloxacin in microgravity International Head-Out Water Immersion Symposium, Houston, October 2002.

478. H. Derendorf Relevance of protein binding and lung activation for inhaled corticosteroids Inhaled Corticosteroids in Asthma Maangement, Cannes, November 2002.

479. A. Khunvichai, M. Hirt, M. KArmann, k. Rand, H. Derendorf A novel indirect response PK-PD model to characterize the effect of faropenem on Streptococcus pneumoniae and Hemophilus influenzae Globalization of Pharmaceutics Education Network Meeting, Ann Arbor, November 2002.

480. J. Kurz, V.A. Bhattaram, H. Derendorf Predictions of dose-dependent pharmacokinetics of prednisolone Globalization of Pharmaceutics Education Network Meeting, Ann Arbor, November 2002.

481. P. Liu, M. Müller, M. Grant, K. Rand, H. Derendorf Pharmacokinetics and pharmacodynamics of cefpodoxime and cefixime Globalization of Pharmaceutics Education Network Meeting, Ann Arbor, November 2002.

482. Q. Liu, N. Lamberty, S. Hintze, K. Rand, H. Derendorf In vitro pharmacodynamic modeling of ceftriaxone Globalization of Pharmaceutics Education Network Meeting, Ann Arbor, November 2002.

483. V.A. Schuck, M. Müller, M. Grant, G. Hochhaus, H. Derendorf Use of microdialysis to evaluate dexamethasone tissue distribution after oral and topical administration Globalization of Pharmaceutics Education Network Meeting, Ann Arbor, November 2002.

484. J. Kurz, V.A. Bhattaram, H. Derendorf Predictions of dose-dependent pharmacokinetics of prednisolone 2002 AAPS Annual Meeting and Exposition, Toronto, November 2002.

485. V.A. Schuck, M. Müller, M. Grant, G. Hochhaus, H. Derendorf Use of microdialysis to evaluate dexamethasone tissue distribution after oral and topical administration 2002 AAPS Annual Meeting and Exposition, Toronto, November 2002.

486. V.A. Bhattaram, R.P.E. Yanong, E. Curtis, N. Ketabi, M. Gopalakrishnan, N.V. Nagaraja, H. Derendorf Single dose pharmacokinetic studies of florfenicol in Koi (Cyprinus carpio) and Blue Gouramis (Trichogaster trichopterus) 2002 AAPS Annual Meeting and Exposition, Toronto, November 2002.

487. V.A. Bhattaram, A.L. Shroads, G.N. Henderson, A.D. Hutson, S. Krishna, G. Bedo- Addo, A. Owusu-Ofori, N.V. Nagaraja, T. Planche, T. Agbenyega, D. Ansong, H. Derendorf, P.W. Stacpoole Population kinetics-dynamics, efficacy and safety of dichloroacetate for lactic acidosis due to severe malaria 2002 AAPS Annual Meeting and Exposition, Toronto, November 2002.

488. P. Liu, M. Grant, M. Müller, K. Rand, H. Derendorf Pharmacokinetics and pharmacodynamics of cefpodoxime and cefixime 2002 AAPS Annual Meeting and Exposition, Toronto, November 2002.

489. Q. Liu, N. Lamberty, S. Hintze, K. Rand, H. Derendorf In vitro pharmacodynamic modeling of ceftriaxone 2002 AAPS Annual Meeting and Exposition, Toronto, November 2002.

490. A. Khunvichai, M. Hirt, M. Karmann, K. Rand, H. Derendorf A novel indirect response PK-PD model to characterize the effect of faropenem on Streptococcus pneumoniae and Hemophilus influenzae 2002 AAPS Annual Meeting and Exposition, Toronto, November 2002.

491. H. Derendorf Integrating preclinical data into clinical phases of drug development EUFEPS Conference on Optimising Drug Development, Basel, December 2002.

492. H. Derendorf Biomarkers and PK/PD Modelling Conference on Innovative Strategies for Achieving Clinical Proof-of-Concept, Phoenix, January 2003.

493. E.L. Schuck, A. Dalhoff, H. Stass, H. Derendorf Pharmacokinetic-pharmacodynamic (PK/PD) evaluation of a once-daily treatment using ciprofloxacin in an extended-release dosge form Hot Topics in Urinary Tract Infections, Budapest, January 2003.

494. S. Rohatagi, H. Derendorf, K. Zech, R. Nave, D. Banerji PK/PD of Inhaled Corticosteroids: The Risk/Benefit of Inhaled Ciclesonide 60th Anniversary Meeting of AAAAI, Denver, March 2003.

495. H. Derendorf, H. Möllmann Are all steroids alike? Garmisch Drug Forum, Garmisch-Partenkirchen, April 2003.

496. H. Derendorf Microdialysis in drug development Health Care Forum NRW, Cologne, April 2003.

497. H. Derendorf The general concepts of pharmacokinetics and pharmacodynamics 13th European Congress of Clinical Microbiology and Infectious Diseases, Glasgow, May 2003.

498. H. Derendorf Kill curve analysis 13th European Congress of Clinical Microbiology and Infectious Diseases, Glasgow, May 2003.

499. H. Derendorf Clinical pharmacokinetic monitoring 4th Spring Conference on Clinical Pharmacy, Lisbon, May 2003.

500. H. Derendorf Redirecting our attention to the PK/PD profile: Relevance in clinical practice XXII Congress of the European Academy of Allergology and Clinical Immunology, Paris, June 2003.

501. H. Derendorf Modelling of anti-infective drugs 10th Scientific Meeting of the European Society of Chemotherapy Vienna, June 2003.

502. H. Derendorf PK/PD of ICS therapy and the clinical implications MST Asthma Educational Session, Baltimore, August 2003.

503. E.S. El Desoky, V.A. Bhattaram, S. El Din Amry, H. Derendorf Population analysis of intravenous digoxin therapy in pediatric patients 8th International Congress of Therapeutic Drug Monitoring & Clinical Toxicology, Basle, September 2003.

504. H. Derendorf MIC indices or kill curve analysis. Pro and cons. Workhop on Predicitve Value of PK/PD Models of Antimicrobial Drugs, Leiden, September 2003.

505. H. Derendorf New methods to investigate the antibacterial efficacy of antibiotics Workshop on Antibiotic Therapy of Ambulatory Acquired Pulmonary Infections, Zurich, September 2003.

506. H. Derendorf The general concepts of pharmacokinetics and pharmacodynamics 43rd Annual ICAAC, Chicago, September 2003.

507. H. Derendorf Kill curve analysis 43rd Annual ICAAC, Chicago, September 2003.

508. H. Derendorf New developments in tissue pharmacokinetics 43rd Annual ICAAC, Chicago, September 2003.

509. Q. Liu, K.H. Rand, H. Derendorf Impact of tazobactam pharmacokinetics on the antimicrobial effect of piperacillin- tazobactam combinations 43rd Annual ICAAC, Chicago, September 2003

510. E.L. Schuck, A. Dalhoff, H. Stass, H. Derendorf Modeling the biphasic killing kinetics of ciprofloxacin 12th ISAP International Symposium, Chicago, September 2003.

511. Q. Liu, K. Rand, H. Derendorf PK/PD Modeling of antiinfective activity and resistance 12th ISAP International Symposium, Chicago, September 2003.

512. Q. Liu, K. Rand, H. Derendorf Impact of tazobactam pharmacokinetics on the antimicrobial effect of piperacillin- tazobactam combinations 12th ISAP International Symposium, Chicago, September 2003.

513. H. Derendorf Seeking to improve the benefit-risk ratio of inhaled steroids Child & Adolescent Asthma – Current & Future Management, Chicago, September 2003.

514. H. Derendorf New developments in the area of inhaled glucocorticoids 32nd Annual Meeting of the American College of Clinical Pharmacology, Tampa, September 2003.

515. H. Derendorf Pharmacokinetics of natural products 32nd Annual Meeting of the American College of Clinical Pharmacology, Tampa, September 2003.

516. J. Winkler, V.A. Bhattaram, H. Derendorf Predictions of dose-dependent pharmacokinetics and pharmacodynamics of prednisolone 32nd Annual Meeting of the American College of Clinical Pharmacology, Tampa, September 2003.

517. A. Khunvichai, M. Karmann, M. Hirt, L. Joliffe, H. Derendorf Pharmacokinetic/pharmacodynamic modeling of faropenem daloxate 32nd Annual Meeting of the American College of Clinical Pharmacology, Tampa, September 2003.

518. E.L. Schuck, A. Dalhoff, H. Stass, H. Derendorf Pharmacokinetic/pharmacodynamic (PK/PD) evaluation of a onece-daily treatment using ciprofloxacin in an extended-release dosage form 32nd Annual Meeting of the American College of Clinical Pharmacology, Tampa, September 2003.

519. H. Derendorf Pharmacokinetics and pharmacodynamics of anti-infective agents in renal impairment NephroPharmacology 7, Ulm, October 2003.

520. H. Derendorf Integration of preclinical data to streamline clinical drug development 2003 AAPS Annual Meeting, Salt Lake City, October 2003.

521. V.A. Schuck, I. Rinas, H. Derendorf In vitro microdialysis of docetaxel 2003 AAPS Annual Meeting, Salt Lake City, October 2003.

522. A. Khunvichai, M. Hirt, M. Karmann, L.Joliff, I. Zdrojewski, K. Rand, H. Derendorf A novel indirect response PK-PD model to characterize the effect of faropenem on Streptococcus pneumoniae and Haemophilus influenzae 2003 AAPS Annual Meeting, Salt Lake City, October 2003.

523. E.L. Schuck, A. Dalhoff, H. Stass, H. Derendorf Modeling the biphasic killing kinetics of quinolones 2003 AAPS Annual Meeting, Salt Lake City, October 2003.

524. H. Derendorf How the lung handles drugs, permeability, metabolism and retention Transatlantic Airway Conference, Lucerne, January 2004.

525. H. Derendorf Pharmacokinetics of antimicrobial agents Antibiotic Therapy and DRGs, Berlin, January 2004.

526. H. Derendorf Pharmacokinetics and pharmacodynamics: Relevance for asthma therapy 45th Congress of the German Society for Pulmunology, Frankfurt, March 2004.

527. H. Derendorf Comparing potencies of inhaled steroids Annual Meeting of the American Academy of Allergy, Asthma and Immunology, San Francisco, March 2004.

528. H. Derendorf Microdialysis as a key technique to evaluate exposure-response relationships in drug development Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Miami, March 2004.

529. H. Derendorf Microdialysis as a key technique to evaluate exposure-response relationships in drug development FDA Committee for Advanced Education Workshop, Rockville, March 2004.

530. R. Madabushi, V.A. Bhattaram, E.L. Desoky, H. Derendorf Population pharmacokinetic analysis of digoxin in egyptian pediatric patients: A comparison of three different softwares 6th Annual Conference & Themed Workshop of the East Coast Population Analysis Group, Rockville, April 2004.

531. H. Derendorf Pharmaceutical care and health care politics Konrad Adenauer Society, Langenfeld, April 2004.

532. H. Derendorf The general concepts of pharmacokinetics and pharmacodynamics 14th European Congress of Clinical Microbiology and Infectious Diseases, Prague, May 2004.

533. H. Derendorf Kill-curve analysis 14th European Congress of Clinical Microbiology and Infectious Diseases, Prague, May 2004.

534. H. Derendorf, P. Liu, K. Rand, B. Obermann Pharmacokinetic-pharmacodynamic modelling of activities of cefpodoxime and cefixime based on in vivo tissue concentrations and in vitro kill curves 14th European Congress of Clinical Microbiology and Infectious Diseases, Prague, May 2004.

535. H. Derendorf What is the best marker for inhaled corticosteroid safety? Eastern Allergy Conference, Key Biscayne, May 2004.

536. H. Derendorf Dose selection for anti-infective drugs PharmForum 2004, Memphis, May 2004.

537. H. Derendorf The pharmacokinetic basis for once-daily dosing of inhaled corticosteroids 100th International Conference of the American Thoracic Society, Orlando, May 2004.

538. Q. Liu, K. Rand, M. Müller, H. Stass, H. Derendorf Pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation of moxifloxacin Annual Infectious Diseases Pharmacotherapy Fellowship Forum, Vail, June 2004.

539. H. Derendorf Microdialysis as a key technique to evaluate exposure-response relationships in drug development 4th International Symposium Microdialysis in Drug Research and Development, Vienna, June 2004.

540. E.L. Schuck, M. Grant, H. Deendorf Pharmacokinetics and tissue penetration of ciprofloxacin in simulated weightlessness: a pilot study 4th International Symposium Microdialysis in Drug Research and Development, Vienna, June 2004.

541. V.A. Schuck, H. Derendorf In vitro and in vivo microdialysis of dexamethasone 4th International Symposium Microdialysis in Drug Research and Development, Vienna, June 2004.

542. V.A. Schuck, I. Rinas, H. Derendorf In vitro microdialysis of docetaxel 4th International Symposium Microdialysis in Drug Research and Development, Vienna, June 2004.

543. H. Derendorf Introduction to PK/PD World Conference on Dosing of Antiinfectives, Nürnberg, September 2004.

544. H. Derendorf PK/PD based on kill curves World Conference on Dosing of Antiinfectives, Nürnberg, September 2004.

545. H. Derendorf Dosing of antiinfectives in special populations World Conference on Dosing of Antiinfectives, Nürnberg, September 2004.

546. H. Derendorf Protein binding – a pharmacologist‟s view World Conference on Dosing of Antiinfectives, Nürnberg, September 2004.

547. H. Derendorf Pharmacodynamics of antibiotics World Conference on Dosing of Antiinfectives, Nürnberg, September 2004.

548. H. Derendorf PK/PD of inhaled corticosteroids Pharmacolgists Workshop on Inhaled Corticosteroids, Konstanz, September 2004.

549. H. Derendorf PK/PD parameters and their impact on adverse events in inhaled corticosteroid therapy Asthma Management Update, New York, September 2004.

550. Q. Liu. K. Rand, M Müller, H. Stass, H. Derendorf Pharmacokinetic/pharmacodynamic modeling and simulation of moxifloxacin for the treatment of Streptocoosus pneumoniae infections 33rd Annual Meeting of the American College of Clinical Pharmacology, Phoenix, October 2004.

551. E. Schuck. M. Grant, H. Derendorf Effect of modeled microgravity on the deposition and tissue enetration of ciprofloxacin in healthy volunteers 33rd Annual Meeting of the American College of Clinical Pharmacology, Phoenix, October 2004.

552. R. Madabushi, V. Bhattaram, E. ElDesoky, H. Derendorf Population pharmacokinetic analysis of digoxin in Egyptian pediatric patients with heart failure 33rd Annual Meeting of the American College of Clinical Pharmacology, Phoenix, October 2004.

553. H. Derendorf Eng‟s principle and the fight against resistance Clinical PK/PD Symposium, Groton/New London, October 2004.

554. H. Derendorf Resistance development – A pharmacological approach Workshop on Antibiotic Therapy of Community Acquired Respiratory Tract Infections, Vienna, October 2004.

555. H. Derendorf The general concepts of pharmacokinetics and pharmacodynamics ISAP Workshop, Washington, October 2004.

556. H. Derendorf PK/PD based on kill curves ISAP Workshop, Washington, October 2004.

557. H. Derendorf Pharmacokinetics of beta-lactamase inhibitors Symposium on New trends in the Therapy of Nosocomial Infections, Washington, October 2004.

558. H. Derendorf Can variability in tissue penetration explain failures or successes of therapy? 44th ICAAC, Washington, October 2004.

559. E.L. Schuck, M. Grant, L. Putcha, H. Derendorf Pharmacokinetic and pharmacodynamic evaluation of ciprofloxacin in modeled microgravity 44th ICAAC, Washington, November 2004.

560. H. Derendorf, E. Schuck, Q. Liu, A. Khunvichai MIC versus kill curve-based PK/PD indices 44th ICAAC, Washington, November 2004.

561. H. Derendorf MIC vs. Kill corve-based PK/PD indices 44th ICAAC, Washington, November 2004.

562. E.L. Schuck, M. Grant, L. Putcha, H. Derendorf Pharmacokinetic and pharmacodynamic evaluation of ciprofloxacin in modeled microgravity ISAP Symposium, Washington, November 2004.

563. H. Derendorf Examples of how PK/PD models that incorporte biomarkers and surrogate endpoints can be used to accelerate drug development: Corticosteroids AAPS Workshop Clinical Biomarkers in Drug Development, Baltimore, November 2004.

564. J. Shen, H. Bozigian, H. Derendorf, S. Struthers, T. Chen, R. Jimenez, B. Campbell Pharmacokinetic and pharmacodynamic evaluation of NBI-42902, a new gonadotropin releasing hormone antagonist, in healthy post-menopausal women 2004 AAPS Annual Meeting, Baltimore, November 2004.

565. S. Sarawek, F. Qadan, H. Derendorf, V. Butterweck An extract of Gundelia tournefortii L. shows hypouricemic activity in in vitro and in vivo assays 2004 AAPS Annual Meeting, Baltimore, November 2004.

566. V. Schuck, H. Derendorf Dexamethasone tissue penetration determined by microdialysis 2004 AAPS Annual Meeting, Baltimore, November 2004.

567. R. Madabushi, V. Bhattaram, E. El Desoky, H. Derendorf Intravenously administered digoxin in Egyptian pediatric patients with heart failure: Population pharmacokinetic analysis 2004 AAPS Annual Meeting, Baltimore, November 2004.

568. R. Madabushi. V. Bhattaram, E. El Desoky, H. Derendorf Mixed effects modeling of sparse data: A comparison of NONMEM and PKBUGS 2004 AAPS Annual Meeting, Baltimore, November 2004.

569. Q. Liu, K. Rand, M. Mueller, H. Stass, H. Derendorf Pharmacokinetic/pharmacodynamic (PK/PD) modeling of antimicrobial effect and resistance development for moxifloxacin and ceftriaxone 2004 AAPS Annual Meeting, Baltimore, November 2004.

570. E. Schuck, M. Grant, L. Putcha, H. Derendorf Pharmacokinetics and pharmacodynamics of ciprofloxacin in simulated microgravity 2004 AAPS Annual Meeting, Baltimore, November 2004.

571. H. Derendorf, C.P. VanderMaelen, R.S. Brickl, W. Eisert Improved dipyridamole formulation insures absorption in elderly patients Karolinska Stroke Update, Stockholm, November 2004.

572. H. Derendorf Corticosteroid PK/PD parameters and their relationship to safety and efficacy Southwest Allergy Forum, Puerto Vallarta, January 2005.

573. H. Derendorf Integration of PK-PD modeling and simulation in the development of new anti- infective agents Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics, Orlando, March 2005.

574. H. Derendorf Pharmacology of inhaled corticosteroids: Are they all alike? Annual Meeting of the German Pulmunology Society, Berlin, March 2005.

575. H. Derendorf Basics of pharmacokinetics and pharmacodynamics Workshop on Optimum Therapy of Complicated Infections, Berlin, March 2005.

576. H. Derendorf Pharmacokinetics and pharmacodynamics of piperacillin-tazobactam and tigecycline Workshop on Optimum Therapy of Complicated Infections, Berlin, March 2005.

577. H. Derendorf, P. Liu, K. Rand, B. Obermann MIC vs. kill curve based pharmacokinetic/pharmacodynamic modeling of activities of cefpodoxime and cefixime 15th ECCMID, Copenhagen, April 2005

578. H. Derendorf The importance of protein binding and how to expose highly-protein bound antimicrobials in the in-vitro model Post-ECCMID ISAP Meeting, Copenhagen, April 2005.

579. H. Derendorf Pharmacology of inhaled corticosteroids – Are they all alike? Pneumological Workshop on Asthma, Frankfurt, April 2005.

580. H. Derendorf Daptomycin – Profile, pharmacokinetics, pharmacodynamics and side effects Daptomycin Expert Meeting, Berlin, April 2005.

581. H. Derendorf, G. Hochhaus Relevance of pharmacokinetic and pharmacodynamic data in the efficacy and safety of inhaled corticosteroids 5th Retrometabolism Based Drug Design and Targeting Conference, Hakone, May 2005

582. H. Derendorf Special PK/PD characteristics of proteins and peptides 1st PharmSciFair, Nice, June 2005.

583. H. Derendorf Optimizing drug development of anti-infective agents using pharmacokinetics and pharmacodynamics Faculty Award Presentation, University of Utrecht, June 2005.

584. H. Derendorf, S. Mertens-Talcott, V. Butterweck Recent advances in food-drug interactions: How concerned should we be? 2005 Institute of Food Technologists Annual Meeting, New Orleans, July 2005.

585. H. Derendorf, V. Butterweck Pharmacokinetics and drug interactions of herbal medicinal products 53rd Annual Congress of the Society for Medicinal Plant Research, Florence, August 2005

586. W.V. de Castro, S. Mertens-Talcott, A. Rubner, V. Butterweck, H. Derendorf Great variability of flavonoids and furanocoumarins in commercially available grapefruit juices: A source of inconsistancy in grapefruit-drug interaction studies 53rd Annual Congress of the Society for Medicinal Plant Research, Florence, August 2005

587. M.J. Salvador, S. Mertens-Talcott, E.O. Ferreira, W.V. de Castro, V. Butterweck, H. Derendorf, D.A. Dias Phenolic constituents and antioxidant capacity of Alternanthera tenella Colla 53rd Annual Congress of the Society for Medicinal Plant Research, Florence, August 2005

588. W.V. de Castro, S. Mertens-Talcott, A. Rubner, V. Butterweck, H. Derendorf Flavonoids and furanocoumarins in grapefruit juice: Analysis and effect of naringin and 6‟,7‟-dihydroxybergamottin on P-glycoprotein in vitro 34th Annual Meeting of the American College of Clinical Pharmacology, Rockville, September 2005.

589. O. Burkhardt, R. Madabushi, C. Lehmann, T. Welte, H. Derendorf Once-daily tobramycin in cystic fibrosis: Better clinical outcome then tid but more resistance development? 34th Annual Meeting of the American College of Clinical Pharmacology, Rockville, September 2005.

590. H. Derendorf In vitro and animal models for the development of surrogate markers for optimal microbiological and clinical outcome 34th Annual Meeting of the American College of Clinical Pharmacology, Rockville, September 2005.

591. H. Derendorf Quantification of biomarkers and integration with exposure for dose optimization AAPS Workshop on Integrated Roadmap to Biomarkers for Drug Development – Method Validation and Qualification, Rockville, September 2005.

592. H. Derendorf PK/PD in special populations 7th European Congress of Chemotherapy and Infection, Florence, October 2005.

593. H. Derendorf PK/PD – does it make a difference? 7th European Congress of Chemotherapy and Infection, Florence, October 2005.

594. H. Derendorf Trends in Pharmacy and opportunities for the future Forum Futurum, Miami, November 2005.

595. V. Kumar, R. Madabushi, L.A. Boothby, H. Derendorf Development and validation of an HPLC-UV method for oxytocin quantitation in Ringer lactate solution for stability studies AAPS Annual Meeting, Nashville, November 2005.

596. W. Castro, S. Talcott-Mertens, A. Rubner, V. Butterweck, H. Derendorf Analysis of flavonoids and furanocoumarins in grapefruit juice AAPS Annual Meeting, Nashville, November 2005.

597. O. Burkhardt, C. Lehmann, R. Madabushi, T. Welte, H. Derendorf Once daily tobramycin in cystic fibrosis: Better clinical outcome than TID but more resistance development? 45th Annual ICAAC, Washington, December 2005.

598. H. Derendorf Is protein binding important for lipophilic drugs? 45th Annual ICAAC, Washington, December 2005.

599. H. Deendorf Modeling and simulation for drug candidate selection AGAH/ACCP Workshop on Computer Simulation and its Role in Drug Development, Düsseldorf, February 2006.

600. H. Derendorf Improving asthma therapy through scientific innovation American Academy of Allergy, Asthma and Immunology, Miami, March 2006.

601. H. Derendorf, G. Hochhaus The effect of protein binding om adrenal suppression potential of inhaled corticosteroids American Academy of Allergy, Asthma and Immunology, Miami, March 2006.

602. H. Derendorf Biomarker-guided drug development 2006 Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Baltimore, March 2006

603. H. Derendorf Use of PK/PD modeling to streamline drug development 2006 Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Baltimore, March 2006

604. H. Derendorf Pharmacokinetic exposure, response and dermal drug absorption 2006 Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Baltimore, March 2006

605. S. Mertens-Talcott, W.V. de Castro, V. Butterweck, H. Derendorf Grapefruit drug interactions: The effect of furanocoumarins and polymethoxylated flavones on P-glycoprotein activity in vitro 2006 FASEB Meeting, San Francisco, April 2006.

606. W. Treyapasert, U. Suvanakoot, H. Derendorf Pharmacokinetic-pharmacodynamic modeling of in vitro activity of azithromycin against four different bacterial strains 16ht European Congress of Clinical Microbiology and Infectious Diseases, Nice, April 2006.

607. S. Schmidt, O. Burkhardt, W. Treyaprasert, H. Derendorf PK/PD challenges of in vitro time-kill curves – a new modelling approach 16ht European Congress of Clinical Microbiology and Infectious Diseases, Nice, April 2006.

608. S. Schmidt, O. Burkhardt, S. Schubert, A. Dalhoff, H. Derendorf Carbapenems – differences in their antibacterial activity due to their protein binding 16ht European Congress of Clinical Microbiology and Infectious Diseases, Nice, April 2006.

609. S. Schmidt, O. Burkhardt, M. Sahre, H. Derendorf Experimental pitfalls in protein binding measurements 16ht European Congress of Clinical Microbiology and Infectious Diseases, Nice, April 2006.

610. J. Barth, D. Jäger, M. Müller, O. Burkhardt, H. Derendorf Penetration of moxifloxacin into normal and infected subcutaneous tissue in patients with spinal cord injury measured by microdialysis 16ht European Congress of Clinical Microbiology and Infectious Diseases, Nice, April 2006.

611. H. Derendorf Use of biomarkers, modeling and simulation to streamline drug development 11th Pharmacokinetic/Pharmacodynamic Expert Meeting, Berlin, May 2006.

612. H. Derendorf The race against resistance: How can we find new drugs against bad bugs South Eastern Regional Interdisciplinary Symposium, Gainesville, May 2006.

613. H. Derendorf Strengths and weakness of antimicrobial PK/PD analysis Third International Conference on Antimicrobial Agents in Vetenary Medicine, Orlando, May 2006.

614. H. Derendorf Clinical trials and FDA process British Medical Association, London, July 2006.

615. H. Derendorf Pharmacokinetic options Symposium on Multiresistance and New Antibiotics, Hannover, July 2006.

616. H. Derendorf Pharmacokinetic options Symposium on Multiresistance and New Antibiotics, Hamburg, August 2006. 617. W.V. DeCastro, S.U. Mertens-Talcott, H. Derendorf, V. Butterweck Grapefruit Juice Drug Interactions: grapefruit juice and its components inhibit P- glycoprotein mediated transport of talinolol in Caco-2 Cells 47th Annual Meeting of the American Society of Pharmacognosy, Arlington, August 2006.

618. W.V. DeCastro, S.U. Mertens-Talcott, H. Derendorf, V. Butterweck Grapefruit Juice Drug Interactions: grapefruit juice and its components inhibit P- glycoprotein mediated transport of talinolol in Caco-2 Cells 54th Annual Meeting of the Society of Medicinal Plant Research, Helsinki, September 2006.

619. H. Derendorf Which characteristics of an ICS do you consider to have the most significant impact of effectiveness of the agent? European Respiratory Society Annual Congress, Munich, September 2006.

620. H. Derendorf Pharmacokinetic options Symposium on Multiresistance and New Antibiotics, Berlin, September 2006.

621. H. Derendorf PK/PD as basis of dose optimization Annual Meeting of the German Society for Hygiene and Microbiology, Würzburg, October 2006.

622. H. Derendorf Information on GI performance: nice-to-know or essential tool for accelerated product development and approval? Symposium on Magnetic Marker Monitoring, Berlin, October 2006.

623. H. Derendorf Pharmacokinetics of lipoproteins Daptomycin Symposium, Langenlois, October 2006.

624. S. Sarawek, H. Derendorf, V. Butterweck Xanthine oxidase inhibitory activity of various flavonoids in vitro on plasma uric acid levels in oxonate-induced rats AAPS Annual Meeting, San Antonio, October 2006.

625. V. Kumar, O. Burkhardt, M. Pletz, T. Welte, H. Lode, H. Derendorf Comparison of pharmacodynamic target attainment of ertapenem in healthy volunteers and intensive care unit patients using Monte Carlo simulations AAPS Annual Meeting, San Antonio, October 2006.

626. V.W. DeCastro, S. Talcott, V. Butterweck, H. Derendorf Effects of grapefruit juice and its components on the activity of P-glycoprotein AAPS Annual Meeting, San Antonio, October 2006.

627. S. Talcott, V.W. DeCastro, H. Derendorf, V. Butterweck Citrus flavonoids in the inhibition of P-glycoprotein in vitro AAPS Annual Meeting, San Antonio, October 2006.

628. H. Derendorf Inhaled corticosteroids today: Are they lessening the systemic effects ACAAI Annual Meeting, Philadelphia, November 2006.

629. H. Derendorf Pharmacokinetic/pharmacodynamic modeling: Current concepts Conference on Effective Integration of Systems Biology, Biomarkers, Biosimulation and Modelling in Streamlining Drug Development, Basel, November 2006.

630. M. Lobmeyer, H. Derendorf Clinical manifestation of polymorphisms – Consulting opportunities for pharmacists Bavarian Academy for Clinical Pharmacy, Würzburg, December 2006.

631. W. Treyaprasert, U. Suvanakoot, H. Derendorf Pharmacokinetic-Pharmacodynamic Modeling of In Vitro Activity of Azithromycin Against Four Different Bacterial Strains 23rd Annual Research Conference in Pharmaceutical Sciences and JSPS of Asia/Africa Scientific Program, Bangkok, December 2006.

632. S. Schmidt, H. Derendorf PK/PD modeling of linezolid against MRSA 17th European Congress of Clinical Microbiology and Infectious Diseases, Munich, March 2007.

633. H. Derendorf Introduction to PK/PD of anti-infectives – the essentials in 60 minutes 1st Symposium on PK/PD-approaches to suppression of resistance to anti-infectives, Munich, March 2007.

634. H. Derendorf Models of infection: In vitro vs. in vivo 1st Symposium on PK/PD-approaches to suppression of resistance to anti-infectives, Munich, March 2007.

635. H. Derendorf Introduction to PK/PD 25th ICC Educational Workshop on Pharmacokinetics and pharmacodynamics of anti- infective agents, Munich, March 2007

636. H. Derendorf Pharmacokinetic options Symposium on Multiresistance and New Antibiotics, Munich, April 2007.

637. H. Derendorf Pharmacotherapy in the elderly 3rd Pharmaceutical Sciences World Congress, Amsterdam, April 2007.

638. J. Xu, J. Winkler, H. Derendorf A novel pharmacokinetic/pharmacodynamic (PK/PD) approach to predict total prednisolone levels in human plasma 3rd Pharmaceutical Sciences World Congress, Amsterdam, April 2007.

639. Y. Li, C.J. Clancy, M.H.T. Nguyen, H. Derendorf Time-kill and post-antifungal effects (PAFE) of voriconazole against Candida clinical strains: Verifying experimental validity by determination of voriconazole concentrations using HPLC 3rd Pharmaceutical Sciences World Congress, Amsterdam, April 2007.

640. H. Derendorf The significance of an optimized formulation for dipyridamole 16th European Stroke Conference, Glasgow, May 2007.

641. H. Derendorf Pharmacokinetic/pharmacodynamic studies in drug product development 6th Retrometabolism Based Drug Design and Targeting Conference, Göd, June 2007.

642. H. Derendorf Phamacists in the USA – Experience and future opportunities Northrhine Chamber of Pharmacists, Neuss, June 2007. . 643. V. Kumar, E.S. ELDesoky, M.M. Hamdi, M. Alorainy, H. Derendorf Population pharmacokinetics of lithium in Egyptian patients with bipolar affective disorder 36th ACCP Annual Meeting, San Francisco, September 2007.

644. S. Schmidt, D. Abbanat, P. Manitpisitkul, J. Blake, S. Sha, H. Derendorf Linezolid against MRSA – A new modeling approach 36th ACCP Annual Meeting, San Francisco, September 2007.

645. H. Derendorf Tissue levels of antibiotics HAI-Congress of Anesthesiology and Intensive Care Medicine, Berlin, September 2007.

646. H. Derendorf Tissue penetration and PK/PD of antibiotics HAI-Congress of Anesthesiology and Intensive Care Medicine, Berlin, September 2007.

647. H. Derendorf Introduction to PK/PD 47th Annual ICAAC, Chicago, September 2007.

648. H. Derendorf PK/PD based on kill curves 47th Annual ICAAC, Chicago, September 2007.

649. H. Derendorf Shortcomings of current pharmacodynamic assessment tools 47th Annual ICAAC, Chicago, September 2007.

650. S. Schmidt, A. Barbour, O. Ghobrial, D. Abbanat, P. Manitpisitkul, J. Blake, S. Sha, H. Derendorf Characterization of in vitro resistance to RWJ-416457 against MRSA compared to linezolid 47th Annual ICAAC, Chicago, September 2007.

651. Y. Li, H. Derendorf, M.H. Nguyen, C.J. Clancy Pharmacokinetic (PK)/pharmacodynamic (PD) modeling of voriconazole activity against Candida spp. using a dynamic in-vitro model 47th Annual ICAAC, Chicago, September 2007.

652. H. Badrane, M.H. Nguyen, V. Kumar, H. Derendorf, C.J. Clancy Candida albicans Irs4p interacts with Inp51p to regulate phosphatidylinositol-4,5- biphosphate (PI(4,5)P2) levels, vesicle trafficking and virulence 47th Annual ICAAC, Chicago, September 2007.

653. H. Derendorf Galenic formulations of dipyridamole Future Perspectives in Modern Stroke Management, Warsaw, September 2007.

654. H. Derendorf The use of PK/PD in drug development 39th Brazilian Congress of Pharmacology and Experimental Therapeutics, Ribeirão Preto, October 2007.

655. J. Xu, J. Winkler, H. Derendorf Impact of dosing time on the pharmacokinetics/pharmacodynamics of prednisone AAPS 2007 Annual Meeting, San Diego, November 2007.

656. H. Derendorf PK/PD modeling and the rational selection of dosage regimens for the prudent use of antimicrobial drugs 2nd Symposium on Antimicrobial Resistance in Animals and the Environment, Tours, December 2007.

657. Y. Li, M. Nguyen, H. Derendorf, C. J. Clancy Dynamic time-kill experiments and pharmacokinetic/pharmacodynamic mathematical models of voriconazole activity against Candida isolates in vitro support target peak concentrations of 4×MIC 9th ASM Conference on Candida and Candidiasis, Jersey City, March 2008.

658.

Research Group

Dr. Gotelind Mullersman (Post-doc) Dr. Richard Vistelle (Post-doc) Dr. Jobst Limberg (Post-doc) Dr. Volker Keuth (Post-doc) Dr. Hans-Günter Schäfer (Post-doc) Dr. Klaus Dietzel (Post-doc) Dr. Burkhard Wichert (Post-doc) Dr. Long-Shiuh Chen (Post-doc) Dr. George Henderson (Post-doc) Dr. Stefan Balbach (Post-doc) Dr. Siyawosh Moghaddam (Post-doc) Dr. Andreas Kovar (Post-doc) Dr. Bernd Meibohm (Post-doc) Dr. Birgit Pechstein (Post-doc) Dr. Nelamangala Nagaraja (Post-doc) Dr. Atul Bhattaram (Post-doc) Dr. Maria Gogova (Post-doc) Dr. Rajanikanth Madabushi (Post-doc) Dr. Susanne Mertens-Talcott (Post-doc) Dr. Olaf Burkhardt (Post-doc) Dr. Vipul Kumar (Post-doc) Dr. Eliane Oliveira Ferreira (Post-doc) Dr. Marcos Salvador (Post-doc) Dr. Hao Pan (Post-doc) Dr. Sabarinath Sreedharan Nair (Post-doc) Prof. Maritza Cediel (Visiting Professor) Prof. Carolina Vivas (Visiting Professor) Prof. Cioli Rojas (Visiting Professor) Prof. Dr. Markus Müller (Visiting Professor) Prof. Dr. Samia Mostafa (Visiting Professor) Prof. Dr. Bernd Jilma (Visiting Professor) Kiman Kim (Visiting Scientist) Dr. Yan-hong Liu (Visiting Scientist)

Susan Stout (Graduate Student) Robert Townsend (Graduate Student) Matthieu Kaltenbach (Graduate Student) Sumia Mohamed (Graduate Student) Arno Nolting (Graduate Student) Michael Marcon (Graduate Student) Ajit Suri (Graduate Student) Shashank Rohatagi (Graduate Student) Viny Srinivasan (Graduate Student) Teresa Dalla Costa (Graduate Student) Pedro Froehlich (Graduate Student) Sanja Modric (Graduate Student) Amparo de la Peña (Graduate Student) Sriram Krishnaswami (Graduate Student) Ulrike Gräfe (Graduate Student) Ping Liu (Graduate Student) Julia Winkler(Graduate Student) Ariya Khunvichai (Graduate Student) Dorothee Krone (Graduate Student) Antina Barger (Graduate Student) Claudia Kohlert (Graduate Student) Edgar Schuck (Graduate Student) Virna Schuck (Graduate Student) Qi Liu (Graduate Student) Sabine Wittemer (Graduate Student) Whocely Victor de Castro (Graduate Student) Immo Zdrojewski (Graduate Student) Wanchai Treyaprasert (Graduate Student) Elizabeth Potocka (Graduate Student) Stephan Schmidt (Graduate Student) Yanjun Li (Graduate Student) Jiang Liu (Graduate Student) Jian Xu (Graduate Student) April Barbour (Graduate Student) Oliver Ghobrial (Graduate Student) Martina Sahre (Graduate Student) Rong Shi (Graduate Student) Runa Naik (Graduate Student)

Martina Butschkau (Pharmacist, Research Associate) Sophie Toufflin (Pharmacist, Research Associate) Jean-Frederic Lefevre (Pharmacist, Research Associate) Yau-Lin Kan (Pharmacist, Research Associate) Elsbeth Brunt (Pharmacist, Research Associate) Tessa Ververs (Pharmacist, Research Associate) Olivier Makil (Pharmacist, Research Associate) Herbert Schmidt (Pharmacist, Research Associate) Hanneke Schreurs (Pharmacist, Research Associate) Bettina Goldberg (Pharmacist, Research Associate) Myriam Damoiseaux (Pharmacist, Research Associate) Ewoud van Winden (Pharmacist, Research Associate) Andrea Soldner (Pharmacist, Research Associate) Jan Georg Möller (Pharmacist, Research Associate) Eric Galia (Pharmacist, Research Associate) Bart Metselaar (Pharmacist, Research Associate) Heike Bauer (Pharmacist, Research Associate) Christine Schäfer (Pharmacist, Research Associate) Ulrike Gräfe (Biologist, Research Associate) Andrea Hämmerlein (Pharmacist, Research Associate) Christine Wellsow (Pharmacist, Research Associate) Meyling Cheok (Pharmacist, Research Associate) Otmar Abbas (Pharmacist, Research Associate) Anne Gräbe (Pharmacist, Research Associate) Jana Pfeifer (Pharmacist, Research Associate) Cornelia Dressler (Pharmacist, Research Associate) Ulrike Krauss (Pharmacist, Research Associate) Frank Deselaers (Pharmacist, Research Associate) Julia Kurz (Pharmacist, Research Associate) Petra Lensing (Pharmacist, Research Associate) Olaf Orthen (Pharmacist, Research Associate) Daniel Svedmyr (Pharmacist, Research Associate) Kennia Rocha Rezende (Pharmacist, Research Associate) Susanne Kunz (Pharmacist, Research Associate) Marion Stoll (Pharmacist, Research Associate) Nahal Ketabi (Pharmacist, Research Associate) Jörg Stütz (Pharmacist, Research Associate) Marion Hirt (Pharmacist, Research Associate) Michaela Karmann (Pharmacist, Research Associate) Juliane Platz (Pharmacist, Research Associate) Richard Fuhrherr (Pharmacist, Research Associate) Sabine Hintze (Pharmacist, Research Associate) Saskia Stilke (Pharmacist, Research Associate) Nina Lamberty (Pharmacist, Research Associate) Anja Klein (Pharmacist, Research Associate) Irene Rinas (Pharmacist, Research Associate) Immo Zdrojewski (Pharmacist, Research Associate) Jana Kroll (Pharmacist, Research Assistant) Christian Scheerans (Pharmacist, Research Assistant) Christian Hampp (Pharmacist, Research Assistant) Ralph Rüdiger Holl (Pharmacist, Research Assistant) Dirk Krane (Pharmacist, Research Assistant) Nina Schulte-Loebbert (Pharmacist, Research Assistant) Birgit Hempsch (Pharmacist, Research Assistant) Stephan Schmidt (Pharmacist, Research Assistant) Stefan Galler (Pharmacist, Research Assistant) Anne Wandrey (Pharmacist, Research Assistant) Sarah Thum (Pharmacist, Research Assistant) Anne Wandrey (Pharmacist, Research Associate) Stefan Galler (Pharmacist, Research Associate) Anke Rubner (Pharmacist, Research Associate) Melanie Hübner (Pharmacist, Research Associate) Vanessa Klett (Pharmacist, Research Associate) Franziska Ihle (Pharmacist, Research Associate) Matthias Fueth (Pharmacist, Research Associate) Sarah Dizayee (Pharmacist, Research Associate) Philos Shtapit (Pharmacist, Research Associate) Dörthe Ludwig (Pharmacist, Research Associate) Kira Namockel (Pharmacist, Research Associate) Martina Sahre (Pharmacist, Research Associate) Sandra Weiss (Pharmacist, Research Associate) Rebecca Banks (Pharmacist, Research Associate) Katharina Röck (Pharmacist, Research Associate)

Funding for Research

1983 Division of Sponsored Research, University of Florida, New Faculty Research Support ($9,480).

Hoechst-Roussel Pharmaceuticals, Inc. (with R.L. Yost) Prepharmacokinetic studies on cefotaxime and its metabolites ($7,000).

Hoechst-Roussel Pharmaceuticals, Inc. (with R.L. Yost) Pharmacokinetic studies in morbidly obese patients using cefotaxime ($22,000).

College of Pharmacy, University of Florida Biomedical Research Support Grant ($5,000).

Perkin-Elmer Corp. Research Donation ($2,687).

State of Florida Development of electrochemical techniques to determine morphine - derivatives ($4,000).

1984 State of Florida Development of electrochemical techniques to determine morphine- derivatives ($24,000).

College of Pharmacy, University of Florida Biomedical Research Support Grant ($5,000).

Hugh Little Research Donation ($l2,000).

1985 Boots Inc. (with J. Perrin) Bioavailability of codeine and ibuprofen ($65,520).

State of Florida Development of electrochemical techniques to determine morphine - derivatives ($24,000).

Boots Inc. (with J. Perrin) Plasma levels of a new ibuprofen formulation ($22,464).

Glaxo Inc. Interaction of sucralfate and ranitidine ($9,000).

Boots Inc. (with J. Perrin) Bioavailability of ibuprofen suspensions ($13,690).

1986 College of Pharmacy, University of Florida Biomedical Research Support Grant ($1,950).

Janssen Pharmaceuticals Comparison of Sufentanil vs Fentanyl vs Isoflurane in Neuroanesthesia (PI B. L. Grundy, $35,000).

Cyanamid Interaction between diclofenac and triamcinolone acetate ($5,000).

Embil Pharmaceuticals Analysis and stability of conjugated estrogens ($1,500).

State of Florida Development of electrochemical techniques to determine morphine - derivatives ($18,638).

1987 Hoechst Pharmacokinetics of methylprednisolone phosphate ($10,000).

Hoffmann-LaRoche Erythrocyte binding of fleroxacin ($8,300).

Pharmatec Inc. Bioavailability of estradiol-CDS ($9,000).

Merck (with J. Perrin) Pharmacokinetic interactions between glipizide and lovastatin ($10,395).

1988 Organon Pharmacokinetics of intraarticular glucocorticoids ($10,816).

Schering Bioavailability of theophylline ($25,760).

Pharmatec Inc. Bioavailability of estradiol-CDS ($18,000).

1989 Pharmatec Inc. Bioavailability of estradiol-CDS ($30,000).

Xenon Inc. (with G. Hochhaus) Pharmacokinetics of glucocorticoids ($11,000)

Bristol-Myers (with H. Schreier) Amikacin microemulsions for drug delivery ($24,000)

1990 Pharmatec Inc. Bioavailability of estradiol-CDS ($20,000).

PMA Foundation Evaluation of calcium blocker/beta blocker interactions ($5,000)

Bristol-Myers (with H. Schreier) Amikacin microemulsions for drug delivery ($46,000.00)

Xenon Inc. (with G. Hochhaus) Pharmacokinetics of loteprednol in dogs ($16,000.00)

1991 Xenon Inc. Stability of soft drugs ($3,500.00)

Thomae (with G. Hochhaus) Pharmacokinetics and pharmacodynamics of dexamethasone isonicotinate ($43,000.00)

Schering-Plough Graduate Student Fellowship ($15,000.00)

NASA Effects of simulated microgravity on the pharmacokinetics and pharmacodynamics of antibiotics ($22,000)

1992 Dept. of Anesthesiology, University of Florida Patient controlled morphine analgesia ($2,000)

Hefa Frenon (with G. Hochhaus) Pharmacokinetics of dexamethasone sulfobenzoate ($10,000)

Dorsch Pharmacokinetics and pharmacodynamics of prednisolone ($10,000)

Schering-Plough Graduate Student Fellowship ($15,000)

Daniels Pharmaceuticals, Inc. Research Donation ($30,000)

Hartford Foundation (with D. Lowenthal) Hepatic Blood Flow and Propranolol Kinetics in Response to Exercise Training in the Elderly ($5,000)

Pfizer, Inc. Evaluation of analgesic activity using tooth pulp evoked potentials ($42,350)

NIH RO1 GM45922 (co-PI, with R. Gonzalez-Rothi) Targeted Liposomal Corticoids for Lung Immunomodulation ($156,563)

1993 Schering-Plough Graduate Student Fellowship ($15,000)

NIH RO1 GM45922 (co-PI, with R. Gonzalez-Rothi) Targeted Liposomal Corticoids for Lung Immunomodulation ($163,234)

Falk (with G. Hochhaus) Pharmacokinetics of Corticosteroids ($40,000)

1994 Glaxo Inc. (with G. Hochhaus) Pharmacokinetics and Pharmacodynamics of Corticosteroids ($120,000)

Byk-Gulden (with G. Hochhaus) Pharmacokinetics of Corticosteroids ($25,000)

NIH RO1 GM45922 (co-PI, with R. Gonzalez-Rothi) Targeted Liposomal Corticoids for Lung Immunomodulation ($163,234)

Cyanamid Pharmacokinetics and Pharmacodynamics of Antibiotics ($50,000)

Falk (with G. Hochhaus) Pharmacokinetics of Corticosteroids ($60,000)

1995 Cyanamid Pharmacokinetics and Pharmacodynamics of Antibiotics ($50,000)

Falk (with G. Hochhaus) Pharmacokinetics of Corticosteroids ($15,000)

1996 Cyanamid Pharmacokinetics and Pharmacodynamics of Antibiotics ($50,000)

Boehringer Ingelheim (with G. Hochhaus) Pharmacokinetics of Corticosteroids ($237,440.00)

1997 Cyanamid Pharmacokinetics and Pharmacodynamics of Antibiotics ($50,000)

Hexal Pharmacokinetics and Pharmacodynamics of Antibiotics ($40,000)

NIH N01-A1-75317 Pathobiology and Treatment of Malaria in Africa (co-I, with P. Stacpoole) ($536,389)

NASA Undergraduate Space Research Grant (with J. Hughes) ($4,000)

Boehringer Ingelheim (with G. Hochhaus) Pharmacokinetics of Corticosteroids in Humans ($146,020)

1998 Glaxo-Wellcome Pharmacokinetics and Pharmacodynamics of Corticosteroids (with G. Hochhaus) ($154,560)

Hexal Pharmacokinetics and Pharmacodynamics of Antibiotics ($40,000)

Cyanamid Pharmacokinetics and Pharmacodynamics of Antibiotics ($50,000)

Boehringer Ingelheim (with G. Hochhaus) Pharmacokinetics of Corticosteroids in Mice ($13,600)

Berlex Stability of fludarabine ($5,000)

1999 Hexal Pharmacokinetics and Pharmacodynamics of Antibiotics ($25,000)

Cyanamid Pharmacokinetics and Pharmacodynamics of Antibiotics ($35,000)

Wyle Laboratories Pharmacokinetics of flurazepam ($9,000)

2000 Hexal Pharmacokinetics and Pharmacodynamics of Antibiotics ($25,000)

Sankyo Pharmacokinetics and Pharmacodynamics of Cefpodoxime ($37,500)

Cyanamid Pharmacokinetics and Pharmacodynamics of Antibiotics ($25,000)

Tropical Aquaculture Laboratory Pharmacokinetics of Flurfenicol ($12,075)

Bayer Pharmacokinetics and Pharmacodynamics of Faropenem ($46,875)

2001 Sankyo Pharmacokinetics and Pharmacodynamics of Cefpodoxime ($62,500)

Bayer Deyermination of kill curves of Faropenem ($187,500)

Cyanamid Pharmacokinetics and Pharmacodynamics of Antibiotics ($25,000)

CAPES Bioavailability of 4-Nerolidylcatechol ($5,774)

Berlex Stability and Sterility of Campath ($5,000)

2002 Sankyo Protein Binding of Cefpodoxime ($12,500)

Innaphase Pharmacokinetic/pharmacodynamic Modeling ($30,000)

Wyeth Pharmacokinetics and Pharmacodynamics of Antibiotics ($25,000)

Center for Biological Defense (with J. Hughes) Expression of Defensins as Novel Anthrax Agents ($125,000)

2003 Sankyo Pharmacodynamics of Cefpodoxime ($75,000)

Florida Department of Citrus Drug Interaction with Citrus Fruits ($24,000)

US Department of Agriculture Grapefruit Juice-Drug Interaction ($232,180)

2004 Wyeth Pharmacokinetics and Pharmacodynamics of Antibiotics ($25,000)

Eisai Microdialysis in Tissues ($5,000)

US Department of Agriculture Grapefruit Juice-Drug Interaction ($207,085)

Pfizer Pharmacokinetics and Skin Microdialysis of Cefpodoxime ($80,000)

State of Florida Department of Citrus Analysis of Atorvastatin ($80,000)

2005 State of Florida Department of Citrus Drug Interactions with Grapefruit Juice ($20,000)

US Department of Agriculture Grapefruit Juice-Drug Interaction ($321,318)

Pfizer Graduate Student Support ($100,000)

Merck Graduate Student Support ($50,000)

2006 Geni Herbs Bioavailability and antioxidant effects of Pomella, a Pomegranate extract ($15,437)

Pfizer Graduate Student Support ($100,000)

Johnson & Johnson In vitro study investigating the effects of antibiotics on bacterial strains ($163,125)

Golin & Harris Drug Interaction Website ($5,000)

Johnson & Johnson Microdialysis validation of ceftobiprole ($43,650)

US Department of Agriculture Grapefruit Juice-Drug Interactions After Acute and Chronic Use ($317,933)

Merck Graduate Student Support ($50,000)

2007 Johnson & Johnson Evaluation of BAL9141 Solution ($14,650) Johnson & Johnson An Exploratory Study to Evaluate the Penetration of Ceftobiprole Into Soft Tissue Determined by In Vivo Microdialysis in Healthy Volunteers ($272,845)

Pfizer Graduate Student Support ($100,000)

Merck Graduate Student Support ($50,000)

2008 Johnson & Johnson Pharmacokinetics of Ceftobiprol ($22,000)

Trius In vitro PK/PD Investigations of TR-700 ($163,125)

Trius Microdialysis Validation of TR-700 ($37,500)

CURRICULUM VITAE

JULIE A. JOHNSON

September 2007

PERSONAL INFORMATION

Address: Residence - 8152 Alderman Road Melrose, Florida 32666

Office - Department of Pharmacy Practice College of Pharmacy The University of Florida Box 100486 Gainesville, FL 32610-0486 Email - [email protected]

Telephone: Residence - (352) 475-9653 Office - (352) 273-6007 FAX - (352) 273-6242

Place of Birth: Greenville, Ohio

Date of Birth: March 22, 1962

EDUCATION AND TRAINING

Bachelor of Science in Pharmacy, The Ohio State University, Columbus, Ohio, June 1985.

Doctor of Pharmacy, The University of Texas at Austin and The University of Texas Health Science Center at San Antonio, August 1987.

Postdoctoral Fellowship in Pharmacokinetics/Clinical Pharmacology - The Ohio State University, Columbus, Ohio. July 1987 to June 1989.

LICENSURE AND BOARD CERTIFICATION

Licensure: Ohio #03317131 (1987 to present) Florida #PS 36111 (2001 to present) Tennessee #007898 (1990 to 1999) Texas #28598 (1985-1988)

Board Certification: Board Certified Pharmacotherapy Specialist October 1992, #292162 Added Qualifications in Cardiology, 2004

Julie A. Johnson Curriculum Vitae - Page 2

PROFESSIONAL APPOINTMENTS

1989-1993 Assistant Professor of Clinical Pharmacy - Department of Clinical Pharmacy, College of Pharmacy, The University of Tennessee, Memphis, Tennessee. August 1989 to June 1993.

1993-1998 Associate Professor of Clinical Pharmacy - Department of Clinical Pharmacy, College of Pharmacy, The University of Tennessee, Memphis, Tennessee. July 1993 to April 1998. Tenure granted July 1995.

1995-1998 Associate Professor of Pharmaceutical Sciences with Graduate Faculty Status - Department of Pharmaceutical Sciences, College of Pharmacy, The University of Tennessee, Memphis, Tennessee. July 1995 to April 1998.

1998-2001 Associate Professor of Pharmacy Practice – Department of Pharmacy Practice, College of Pharmacy, University of Florida, Gainesville, Florida. May 1998 to June 2001. Tenure granted July 1999.

1999-2001 Associate Professor of Medicine – Department of Medicine, Division of Cardiovascular Medicine, College of Medicine, University of Florida, Gainesville, Florida. July 1999 to June 2001.

2001-present Professor of Pharmacy Practice, tenured –Department of Pharmacy Practice, College of Pharmacy, University of Florida, Gainesville, Florida. July 2001 to present.

2001-present Professor of Medicine – Department of Medicine, Division of Cardiovascular Medicine, College of Medicine, University of Florida, Gainesville, Florida. July 2001 to present

2001-present Director, University of Florida Center for Pharmacogenomics. September 2001 to present.

2002-present Professor of Pharmaceutics and Graduate Faculty Member, Department of Pharmaceutics, College of Pharmacy, University of Florida, Gainesville, Florida, July 2002-present

2002-present Chair, Department of Pharmacy Practice, College of Pharmacy, University of Florida. Gainesville, Florida. July 2002 to present

2004-present V. Ravi Chandran Professor of Pharmaceutical Sciences, endowed professorship. September 2004 to present

PROFESSIONAL EXPERIENCE

Community Pharmacy Intern - SuperX Drug Stores, Dublin, Ohio. May 1980 to May 1983.

Hospital Pharmacy Intern - Riverside Methodist Hospital, Columbus, Ohio. May 1983 to June 1985.

Part-time Staff Pharmacist - Bexar County Hospital District, Medical Center Hospital, San Antonio, Texas. July 1985 to July 1987.

Part-time Staff Pharmacist - Drug Emporium, San Antonio, Texas. March 1986 to July 1987.

Part-time Staff Pharmacist - SuperX Drug Stores, Columbus, Ohio, March 1988 to July 1989.

Julie A. Johnson Curriculum Vitae - Page 3

Clinical Pharmacist - Cardiac Intensive Care Unit - Regional Medical Center at Memphis. July 1990 to March 1995 (CICU was closed by the hospital in March 1995).

Clinical Pharmacist - Cardiology/CCU - Veterans Administration Medical Center at Memphis. April 1996 to April 1998.

Clinical Pharmacist – Heart Failure/Heart Transplant Clinic – Shands Hospital at University of Florida. 1998 to 2002.

PROFESSIONAL AFFILIATIONS

American Association of Colleges of Pharmacy American College of Clinical Pharmacy American Heart Association American Society for Clinical Pharmacology and Therapeutics American Society of Human Genetics

GRANTS AND CONTRACTS (EXTRAMURAL)

Current funding

Source: NIH, National Heart Lung and Blood Institute, R01 HL74730 Title: “Hypertension pharmacogenetics” Time period: September 2003 to August 2007 Amount: $2,513,387 (direct), $3,517,699 (total) Role: Principal Investigator

Source: NIH, National Institute of General Medical Sciences, U01 GM74492 Title: “Pharmacogenomic Evaluation of Antihypertensive Responses” Time period: August 2005 to July 2010 Amount: $9,773,655 (direct), $11,149,034 (total) Role: Principal Investigator

Source: NIH, National Heart Lung and Blood Institute, K24 HL68834 Title: “ -receptor polymorphisms and cardiovascular pharmacogenomics” Time period: July 2002 to June 2007 Amount: $554,425 (direct), $598,779 (total) Role: Principal Investigator

Source: American Heart Association, Florida/Puerto Rico Affiliate Title: AHA Postdoctoral Fellowship; Fellow: Jaekyu Shin, Pharm.D. Time period: July 2005-June 2007 Amount: $93,224 Role: Mentor

Source: American Heart Association, Florida/Puerto Rico Affiliate Title: AHA Postdoctoral Fellowship; Fellow: Michael Pacanowski, Pharm.D. Time period: July 2006-June 2008 Amount: $93,224 Role: Mentor

Source: American Heart Association, Florida/Puerto Rico Affiliate Julie A. Johnson Curriculum Vitae - Page 4

Title: AHA Predoctoral Fellowship; Fellow: Anzeela Schentrup, Pharm.D. Time period: July 2006-June 2008 Amount: $43,540 Role: Mentor

Source: American Heart Association, Florida/Puerto Rico Affiliate Title: AHA Predoctoral Fellowship; Fellow: Maximilian Lobmeyer, B.S. Time period: July 2006-June 2008 Amount: $43,540 Role: Mentor

Source: NIH National Heart Lung Blood Institute T32 HL083810 (PI: C. Baylis) Title: “Multidisciplinary Training Program in Hypertension Time period: April 2007 to March 2012 Role: Co-program director

Previous funding (chronological order)

Source: American College of Clinical Pharmacy Research Institute Key Pharmaceuticals Hypertension Research Award. Title: "Role of ß-receptor density and function in the antihypertensive response to metoprolol" Time period: July 1990 to June 1992 Amount: $5,000 Role: Principal Investigator

Source: American Heart Association Tennessee Affiliate, New Investigator Award Title: "Racial differences in ß-blocker response: Examination of receptor mediated mechanisms" Time period: July 1990 to June 1992 Amount: $70,000 Role: Principal Investigator

Source: American Association of Colleges of Pharmacy, New Investigator Grants Program Title: "Mechanisms of racial differences in propranolol pharmacokinetics” Time period: March 1992 to February 1993 Amount: $5,000 Role: Principal Investigator

Source: Baker Norton Pharmaceuticals, Inc. Title: "Determination of verapamil and norverapamil enantiomer concentrations by HPLC" Time period: April 1992 to December 1993 Amount: $173,530 Role: Principal Investigator

Source: American Heart Association, Tennessee Affiliate Grant-in-Aid. Title: "Racial differences in antihypertensive response to ß-blockade" Time period: July 1992 to June 1994 Amount: $50,000 Role: Principal Investigator

Source: Glaxo, Inc. Title: “Racial differences in antihypertensive response to ß-blockade” Time period: December 1992 - November 1994 Amount: $15,600 Role: Principal Investigator

Source: American College of Clinical Pharmacy Research Institute Title: Genentech Cardiovascular Research Fellowship - Fellow: Wendell S. Akers, Pharm.D. Time period: July 1993 to June 1994 Amount: $19,500 Role: Preceptor (Mentor) Julie A. Johnson Curriculum Vitae - Page 5

Source: National Heart Lung and Blood Institute, NIH, R15 HL50055. Title: “Racial differences in propranolol kinetics and response” Time period: May 1993 to April 1996 Amount: $74,983 (direct), $106,851 (total) Role: Principal Investigator

Source: American Heart Association, Tennessee Affiliate Title: AHA Fellowship - Fellow: Kevin M. Sowinski, Pharm.D. Time period: July 1993 to June 1995 Amount: $37,608 Role: Sponsor (Mentor)

Source: American Heart Association, Tennessee Affiliate Grant-in-Aid Title: “Racial differences in 1- and ß2-receptor mediated responses” Time period: July 1994 to June 1996 Amount: $50,000 Role: Principal Investigator

Source: Glaxo Regional Research Institute Title: “ß2-receptor sensitivity in black and white asthmatics” Time period: July 1995 to May 1998 Amount: $43,500 Role: Principal Investigator

Source: NIH, National Institute of General Medical Sciences, R15 GM54297 Title: “Racial differences in propranolol 4-hydroxlyation” Time period: June 1996 to November 1998 Amount: $70,000 (direct), $99,750 (total) Role: Principal Investigator

Source: Searle Title: “The effects of Covera-HS on diurnal variation in forearm vascular resistance and blood pressure in hypertensive patients” Time period: July 1997 to June 1999 Amount: $101,000 Role: Principal Investigator

Source: NIH, National Institute on Aging, R03 AG16854 Title: “ 2-adrenoceptor polymorphisms and hypertension” Time period: April 1999 to March 2000 Amount: $50,000 (direct), $72,250 (total) Role: Principal Investigator

Source: American College of Clinical Pharmacy Research Institute Title: Merck and Company Cardiovascular Fellowship - Fellow: Larisa M. Humma, Pharm.D. Time period: accepted, then declined when AFPE fellowship (below) awarded Amount: $22,500 Role: Preceptor (Mentor)

Source: American Heart Association, Florida/Puerto Rico Affiliate Title: “ 2-adrenoceptor polymorphisms and hypertension” Time period: July 1999 to June 2001 (Award returned upon activation of R01) Amount: $100,000 (direct), $110,000 (total) Role: Principal Investigator

Source: American Foundation for Pharmaceutical Education Title: Post-Pharm.D. Fellowship in Biomedical Research Sciences; Fellow: Larisa M. Humma, Pharm.D. Time period: July 1999 to December 2000 Amount: $55,000 Role: Mentor

Source: American College of Clinical Pharmacy Research Institute Julie A. Johnson Curriculum Vitae - Page 6

Title: Merck and Company Cardiovascular Fellowship - Fellow: Steven G. Terra, Pharm.D., BCPS Time period: July 2000 to June 2001 Amount: $22,500 Role: Preceptor (Mentor)

Source: University of Florida Opportunity Fund Title: “Genetic and pharmacogenetic determinants of outcomes in cardiovascular disease” Time period: March 2001-February 2003 Amount: $175,000 Role: Co-principal Investigator

Source: American Foundation for Pharmaceutical Education Title: Post-Pharm.D. Fellowship in Biomedical Research Sciences; Fellow: Steven G. Terra, Pharm.D. Time period: July 2001-June 2002 Amount: $27,500 Role: Mentor

Source: Orchid Biosciences, Inc Title: “Dobutamine pharmacogenetics” Time period: March 2001 to February 2003 Amount: $58,654 (direct), $73,317 (total) Role: Principal Investigator

Source: NIH, National Heart Lung Blood Institute, R03 HL65729 Title: “ -adrenoceptor genetic polymorphisms and obesity” Time period: April 1, 2001 to March 31, 2003 Amount: $100,000 (direct), $144,500 (total) Role: Principal Investigator

Source: American Foundation for Pharmaceutical Education Title: Post-Pharm.D. Fellowship in Biomedical Research Sciences; Fellow: Christina L. Aquilante, Pharm.D. Time period: July 2002-June 2004 Amount: $55,000 Role: Mentor

Source: American Heart Association, Florida/Puerto Rico Affiliate Title: AHA Postdoctoral Fellowship; Fellow: Issam Zineh, Pharm.D. Time period: July 2002-June 2004 Amount: $76,500 Role: Mentor

Source: NIH, National Heart Lung Blood Institute, Supplement to U01 HL69758 Title: “ -blocker pharmacogenetics in ethnic populations” Time period: November 2001 to October 2003 Amount: $99,988 (direct); $144,983 (total) Role: Principal Investigator of Supplement

Source: Orchid Biosciences, Inc Title: “ -adrenergic receptor polymorphisms and response to -blockers in heart failure” Time period: March 2001 to April 2004 Amount: $248,298 (direct), $303,058 (total) Role: Principal Investigator

Source: NIH, National Heart Lung and Blood Institute, R01 HL64691 Title: “ -adrenergic receptor polymorphisms and hypertension” Time period: May 2000 to April 2005 Amount: $500,000 (direct), $722,500 (total) Role: Principal Investigator

Source: Abbott Laboratories Title: Heart Disease Outcomes: Impact of Genetics and Pharmacogenetics Time period: July 2002 to June 2006 Amount: $1,121,482 (direct); $1,385,310 (total) Julie A. Johnson Curriculum Vitae - Page 7

Role: Principal Investigator

Source: University of Florida Opportunity Fund Title: “Pharmacogenomic Evaluation of Antihypertensive Responses” – Equipment grant Time period: May 2005 Amount: $95,000 Role: Co-principal Investigator

Source: NIH, National Heart Lung Blood Institute, R01 HL64924 Title: “Altered renin angiotensin system as a mechanism for coronary microvascular dysfunction” Time period: May 1, 2001 to April 30, 2006 Amount: $1,686,594 (direct); $2,080,127 (total) Role: Co-Investigator

PUBLICATIONS Original Articles

1. Nahata MC, Johnson JA, Powel DA. Prophylactic antibiotics in plastic surgery. J Qual Assurance 1985; 7: 29-30.

2. Nahata MC, Johnson JA, Powel DA. Management of bronchiolitis. Clin Pharm 1985; 4: 299-303.

3. Nahata MC, Johnson JA, Powel DA. Management of pediatric patients with bronchiolitis in the emergency department. J Qual Assurance 1986;8: 18-21.

4. Lima JJ, Binkley PF, Johnson JA, Leier CV. Dose, time-dependent kinetics and binding of pindolol in patients with congestive heart failure. J Clin Pharmacol 1986; 26: 253-257.

5. (Johnson) Krukemyer JA, Talbert RL. Lovastatin: A new cholesterol lowering agent. Pharmacotherapy 1987;7: 198-210.

6. Lima JJ, (Johnson) Krukemyer JA, Boudoulas H. Drug- hormone-induced adaptation: Model of adrenergic hypersensitivity. J Pharmacokinet Biopharm 1989;17: 347-364.

7. (Johnson) Krukemyer JA, Boudoulas H, Binkley PF, Lima JJ. Biphasic pattern of adrenergic hypersensitivity following abrupt propranolol withdrawal in normal volunteers. Life Sci 1989;45: 1547-1551.

8. (Johnson) Krukemyer JA, Boudoulas H, Binkley PF, Lima JJ. Comparison of adrenergic hypersensitivity following abrupt withdrawal of propranolol and nadolol: Influence of half-life differences. Am Heart J 1990;120: 572-579.

9. (Johnson) Krukemyer JA, Boudoulas H, Binkley PF, Lima JJ. Comparison of single dose and steady state nadolol plasma concentrations. Pharmaceut Res 1990;7: 953-956.

10. (Johnson) Krukemyer JA. Use of ß-adrenergic blocking agents in congestive heart failure. Clin Pharm 1990;9: 853-63.

11. (Johnson) Krukemyer JA, Boudoulas H, Binkley PF, Lima JJ. Relationship between lymphocyte ß-receptor density and physiologic response during and after propranolol and nadolol treatment. Pharmacol (Life Sci Adv) 1990;9: 385-91 .

12. Johnson JA. Diastolic dysfunction in congestive heart failure. Clin Pharm, 1991;10: 850-61.

13. Johnson JA, Burlew BS. Racial differences in propranolol pharmacokinetics. Clin Pharmacol Ther 1992;51: 495-500.

Julie A. Johnson Curriculum Vitae - Page 8

14. Herring VL, Johnson JA. Direct HPLC determination in urine of the enantiomers of propranolol and its major basic metabolite 4-hydroxypropranolol. J Chromatog 1993;612:215-221.

15. Johnson JA. Racial differences in lymphocyte ß-receptor sensitivity to propranolol. Life Sci 1993;53:297-304.

16. Johnson JA, Robinson JL, Rich JM, Boudoulas H, Lima JJ. Differences in apparent sensitivities of chronotropy and inotropy to propranolol. Hellenic J Cardiol 1993;34:256-262.

17. Johnson JA, Burlew BS, Stiles RN. Racial differences in ß-adrenoceptor-mediated responsiveness. J Cardiovasc Pharmacol 1995;25:90-96.

18. Johnson JA, Akers WS, Miller ST, Applegate WB. Metoprolol minimizes nighttime blood pressure dip in hypertensive black males. Am J Hypertens 1995;8:254-259.

19. Johnson JA, Akers WS, Miller ST, Applegate WB. Lymphocyte ß2-receptor activity, metoprolol kinetics and response to metoprolol in hypertensive black males. Pharmacotherapy 1995;15:150- 157.

20. Johnson JA, Akers WS. Influence of metabolites on protein binding of verapamil enantiomers. Br J Clin Pharmacol 1995;39:536-538.

21. Sowinski KM, Burlew BS, Johnson JA. Racial differences in sensitivity to the negative chronotropic effects of propranolol in healthy males. Clin Pharmacol Ther 1995;57:678-83.

22. Sowinski KM, Lima JJ, Burlew BS, Massie JD, Johnson JA. Racial differences in propranolol enantiomer kinetics following simultaneous IV and oral administration. Br J Clin Pharmacol 1996;42:339-46.

23. Johnson JA, Burlew BS. Metoprolol metabolism via CYP2D6 in ethnic populations. Drug Metab Dispos 1996;24:350-355.

24. Johnson JA, Livingston TN. Differences between blacks and whites in plasma protein binding of drugs. Eur J Clin Pharmacol 1997;51:485-488.

25. Johnson JA. Influence of race or ethnicity on pharmacokinetics of drugs. (Invited review) J Pharm Sci 1997;86:1328-1333.

25. Nguyen BNT, Johnson JA. The role of endothelin-1 in heart failure and hypertension. Pharmacotherapy 1998;18:706-719.

26. Mohamed MHN, Lima JJ, Eberle LV, Self TH, Johnson JA. Effects of gender and race on albuterol pharmacokinetics. Pharmacotherapy 1999;19:157-161.

27. Deitcher SR, Tuller J, Johnson JA. Intranasal DDAVP-induced increases in plasma Von Willebrand factor alter the pharmacokinetics of high-purity Factor VIII concentrates in severe hemophilia A patients. Hemophilia, 1999;5:88-95.

28. Lima JJ, Thomason DB, Mohamed MHN, Eberle LV, Self TH, Johnson JA. Impact of genetic

polymorphisms of the 2-adrenergic receptor on albuterol bronchodilator pharmacodynamics. Clin Pharmacol Ther 1999;65:519-525.

29. Johnson JA. Predictability of the effects of race or ethnicity on pharmacokinetics of drugs (Invited review). Int J Clin Pharmacol Ther 2000;38:53-60.

Julie A. Johnson Curriculum Vitae - Page 9

30. Johnson JA, Akers WS, Herring VL, Wolfe MS, Sullivan JM. Gender differences in labetalol kinetics: Importance of determining stereoisomer kinetics for racemic drugs. Pharmacotherapy 2000;20:622-28.

31. Herring VL, Johnson JA. A simple method for determination of terbutaline plasma concentrations by HPLC. J Chromatog B 2000;741:307-312.

32. Lima JJ, Mohamed MHN, Self TS, Eberle LV, Johnson JA. Importance of 2 adrenergic receptor genotype, gender and race on albuterol-evoked bronchodilation in asthmatics. Pulm Pharmacol Ther 2000;13:127-134.

33. Nguyen BNT, Parker RB, Noujedehi M, Sullivan JM, Johnson JA. Effects of COER-verapamil on circadian pattern of blood pressure and forearm vascular resistance. J Clin Pharmacol 2000;40:1480-87.

34. Humma LM, Farmerie WG, Wallace MR, Johnson JA. Sequencing of 2-adrenoceptor gene PCR products using Taq BigDye-Terminator chemistry results in inaccurate base-calling. BioTechniques 2000;29:962-970.

35. Johnson JA, Herring VL, Wolfe MS, Relling MV. CYP1A2 and CYP2D6 4-hydroxylate propranolol and both reactions exhibit racial differences. J Pharmacol Exp Ther 2000;294:1099-1105.

36. Tuteja S, Alloway RR, Johnson JA, Gaber AO. The effect of gut metabolism on tacrolimus bioavailability in renal transplant recipients. Transplantation 2001;71:1303-07.

37. Evans WE, Johnson JA. Pharmacogenomics: The inherited basis for inter-individual differences in drug response. (Invited review) Ann Rev Genomics Hum Genet, 2001;2:9-39.

38. Wang J, Humma LM, Mougey EB, David CJ, Johnson JA, Lima JJ, Sylvester JE. Determination of

human 2-adrenergic receptor haplotypes by denaturation selective amplification and subtractive genotyping. Am J Pharmacogenom 2001;1:315-322.

39. Humma LM, Puckett BJ, Richardson HE, Terra SG, Andrisin TE, Lejeune BL, Farmerie WG, Wallace MR, Lewis JF, McNamara DM, Picoult-Newberg L, Pepine CJ, Johnson JA. Effects of 1- adrenoceptor genetic polymorphisms on resting hemodynamics in patients undergoing diagnostic testing for ischemia. Am J Cardiol 2001;88:1034-37.

40. Johnson JA. Drug target pharmacogenomics: An overview. (Invited review). Am J Pharmacogenomics 2001;1:271-281.

41. Johnson JA, Humma LM. Pharmacogenetics of cardiovascular drugs. (Invited review). Briefings Functional Genom and Proteom 2002;1:66-79.

42. Keltai M, Johnson JA, Kowey PR, Ried LD, Tueth M. INVEST substudies: design and patient characteristics. Clin Cardiol 2001;24:V9-11.

43. Humma LM, Richardson HE, Lewis JF, McGorray SP, Pepine CJ, Johnson JA. Dobutamine pharmacodynamics during Dobutamine Stress Echocardiography and the Impact of -blocker Withdrawal: A report from the NHLBI-sponsored WISE Study. Pharmacotherapy 2002;22:939-46.

44. Andrisin TE, Humma LM, Johnson JA. Collection of genomic DNA by noninvasive mouthwash method for use in pharmacogenetic studies. Pharmacotherapy 2002;22:954-960.

45. Terra SG, Johnson JA. Pharmacogenetics, Pharmacogenomics and Cardiovascular Therapeutics: The Way Forward (Invited review) Am J Cardiovasc Drugs. 2002;2:287-96. Julie A. Johnson Curriculum Vitae - Page 10

46. Johnson JA, Evans WE. Molecular diagnostics as a predictive tool: Genetics of drug efficacy and toxicity. (Invited review) Trends Mol Med 2002;8:300-305.

47. Johnson JA, Terra SG. -adrenergic receptor polymorphisms: Cardiovascular disease associations and pharmacogenetics (Invited review). Pharmaceut Res 2002;19:1779-1787.

48. Johnson JA, Bootman JL, Evans WE, Hudson RA, Knoell D, Simmons L, Straubinger RM, Meyer SM. Pharmacogenomics: A scientific revolution in pharmaceutical sciences and pharmacy practice. Report of the 2001/02 Academic Affairs Committee. Am J Pharmaceut Ed 2002;66:12S-15S.

49. Lou X-Y, Casella G, Littell RC, Yang MCK, Johnson JA, Wu R. A haplotype-based algorithm for multilocus linkage disequilibrium mapping of quantitative trait loci with epistasis. Genetics 2003;163:1533-48.

50. Johnson JA, Zineh I, Puckett BJ, McGorray SP, Pauly DF. 1-adrenergic receptor genetic polymorphisms and antihypertensive response to metoprolol. Clin Pharmacol Ther 2003;74:44-52.

51. Zineh I, Schofield RS, Johnson JA. The evolving role of nesiritide in advanced/decompensated heart failure. Pharmacotherapy 2003;23:1266-1280.

52. Johnson JA, Lima JJ. Drug receptor/effector polymorphisms and pharmacogenetics: Current status and challenges. (Invited review) Pharmacogenetics 2003;13:525-534.

53. Johnson JA. Pharmacogenetics: Potential for individualized drug therapy through genetics. (Invited review) Trends Genet 2003;19:660-666.

54. Aquilante CL, Lobmeyer MT, Langaee TY, Johnson JA. Comparison of CYP2C9 genotyping methods and implications for the clinical laboratory. Pharmacotherapy 2004;24:720-726.

55. Gong Y, Zhu Y, Wang Z, Zhao W, Johnson JA, Wu R. A statistical model for functional mapping of quantitative trait loci regulating drug response. Pharmacogenomics J 2004;4:315-321.

56. Johnson JA, Langaee TY, Zineh I, Beitelshees AL. Caution with 1-adrenergic receptor genotyping (Letter). Clin Pharmacol Ther 2004;76:186.

57. Aquilante CL, Humma LM, Yarandi HN, Andrisin TE, Lewis JF, Hamilton KK, Johnson JA. The influence of sex and race on pharmacodynamics response to dobutamine during dobutamine stress echocardiography. Am J Cardiol 2004;94:535-538.

58. Kim K, Johnson JA, Derendorf H. Differences in drug pharmacokinetics between Asians and Caucasians and the role of genetic polymorphisms. J Clin Pharmacol 2004;44:1083-1105.

59. Liu T, Johnson JA, Casella G, Wu R. Sequencing complex diseases with HapMap. Genetics 2004;168:503-511.

60. Zineh I, Beitelshees AL, Gaedigk A, Walker JR, Pauly DF, Leeder JS, Phillips MS, Gelfand CA, Johnson JA. Pharmacokinetics and CYP2D6 genotypes do not predict metoprolol adverse events or efficacy in hypertension. Clin Pharmacol Ther 2004;76:536-544.

61. Terra SG, Pauly DF, Lee CR, Patterson JH, Adams KF, Schofield RS, Hamilton KK, Aranda JM, Hill JA, Yarandi HN, Johnson JA. Effect of -adrenergic receptor polymorphisms on the tolerability of metoprolol CR/XL in patients with heart failure. Clin Pharmacol Ther 2005;77:127-37.

Julie A. Johnson Curriculum Vitae - Page 11

62. Lima JJ, Beasley BNT, Parker RB, Johnson JA. A pharmacodynamic model of the effects of controlled-onset extended-release verapamil on 24 hour ambulatory blood pressure. Int J Clin Pharmacol Ther 2005;43:187-194.

63. Lin M, Aquilante CL, Johnson JA, Wu R. Sequencing drug response with HapMap. Pharmacogenomics J 2005;5:149-56.

64. Terra SG, Hamilton KK, Pauly DF, Lee CR, Patterson JH, Adams KF, Schofield RS, Belgado BS,

Hill JA, Aranda JM, Yarandi HN, Johnson JA. 1-adrenergic receptor polymorphisms and left ventricular remodeling changes in response to -blocker therapy. Pharmacogenet Genomics 2005;15:227-234.

65. Johnson JA, Cavallari LH. Cardiovascular pharmacogenomics. (Invited review). Exp Physiol 2005;90:283-289.

66. Terra SG, McGorray SP, McNamara DM, Cavallari LH, Wu R, Walker J, Wallace MR, Johnson BD, Bairey Merz CN, Sopko G, Pepine CJ, Johnson JA. Association between -adrenergic receptor polymorphisms and their G-protein coupled receptors with body mass index and obesity in women: A report from the NHLBI-sponsored WISE study. Int J Obes 2005;29:746-54

67. Johnson JA, Turner ST. Hypertension Pharmacogenomics: Current Status and Future Directions. (Invited review) Curr Opin Molec Ther 2005;7:218-225.

68. Aquilante CL, Terra SG, Schofield RS, Pauly DF, Hatton PS, Binkley PF, Johnson JA. Sustained restoration of autonomic balance with long- but not short-acting metoprolol in patients with heart failure. J Card Failure 2006;12:171-76.

69. Aquilante CL , Langaee TY, Lopez LM, Yarandi HN, Tromberg JS, Mohuczy D, Gaston KL, Waddell CD, Chirico MJ, Johnson JA. Influence of coagulation factor, vitamin K epoxide reductase complex subunit 1 and CYP2C9 gene polymorphisms on warfarin dose requirements. Clin Pharmacol Ther 2006;79:291-302

70. Beitelshees AL, Zineh I, Puckett BJ, Yarandi HN, Pauly DF, Johnson JA. Genetic determinants of -blocker response: influence of phenotype and pharmacokinetics on drug target pharmacogenetics. Pharmacogenom J 2006;6:174-78.

71. Lin M, Wu R, Johnson JA. A bivariate model for identifying genetic variants that control drug response for systolic and diastolic blood pressures. Pac Symp Biocomput 2006;11:572-83.

72. Beitelshees AL, Zineh I, Puckett BJ, Yarandi HN, Pauly DF, Johnson JA. Discordant -blocker effects on clinical, ambulatory, resting and exercise hemodynamics in patients with hypertension. Pharmacotherapy 2006;26:1247-1254.

73. Zineh I, Johnson JA. Pharmacogenetics of Chronic Cardiovascular Drugs: Applications and Implications. Exp Opin Pharmacother 2006;7:1417-27.

74. Roden DM, Altman RB, Benowitz NL, Flockhart DA, Giacomini KM, Johnson JA, Krauss RM, McLeod HL, Ratain MJ, Relling MV, Ring H, Shuldiner AR, Weinshilboum RM, Weiss ST, for the Pharmacogenetics Research Network. Pharmacogenomics: challenges and opportunities. Ann Intern Med 2006;145:749-57.

75. Wang D, Papp AC, Binkley PF, Johnson JA, Sadee W. Inter-individual variability in splice variants of L-type voltage-dependent calcium channel alpha subunit 1c (CACNA1C) in human heart tissues. Pharmacogenet Genom 2006;16:735-45.

Julie A. Johnson Curriculum Vitae - Page 12

76. Gong Y, Beitelshees AL, Wessel J, Langaee TY, Schork NJ, Johnson JA. SNP discovery and haplotype analysis of BK channel beta1 subunit. Pharmacogenet Genom 2007;17:267-276.

77. Shin J, Lobmeyer MT, Gong Y, Zineh I, Langaee TY, Yarandi HN, Schofield RS, Aranda JM, Hill JA, Pauly DF, Johnson JA. A ß2-adrenoceptor haplotype is associated with the increased risk for death and heart transplantation in heart failure patients. Am J Cardiol 2007;99:250-55.

78. Lobmeyer MT, Gong Y, Terra SG, Beitelshees AL, Langaee TY, Pauly DF, Schofield RS, Hamilton KK, Patterson JH, Adams KF, Hill JA, Aranda JM, Johnson JA. Synergistic polymorphisms of β1- and α2c-adrenergic receptors and the influence on left ventricular ejection fraction response to β- blocker therapy in heart failure. Pharmacogenet Genom 2007;17:277-282.

79. Wu R, Li H Lin M, Terra SG, Pepine CJ, McGorray SP, Johnson DB, Johnson JA. Epistatic control of human obesity as revealed by linkage disequilibrium mapping: a report from the NHLBI- sponsored WISE Study. Curr Genom 2007;7:463-468.

80. Langaee TY, Gong Y, Yarandi H, Katz D, Cooper-DeHoff RM, Pepine CJ, Johnson JA Association of CYP3A5 polymorphisms with hypertension and antihypertensive response to verapamil. Clin Pharmacol Ther 2007;81:386-91.

81. Gaedigk A, Ndjountsche L, Divakaran K, Bradford LD, Zineh I, Oberlander TF, Brousseau DC, McCarver G, Johnson JA, Alander SW, Riggs W, Leeder JS. Cytochrome P4502D6 (CYP2D6) gene locus heterogeneity: discovery of novel gene duplications in African Americans. Clin Pharmacol Ther 2007;81:242-51.

82. Giacomini KM, Brett CM, Altman RB, Benowitz NL, Dolan EM, Flockhart DA, Johnson JA, Krauss RM, Kroetz DL, McLeod HL, Ratain MJ, Relling MV, Roden DM, Schaefer CA, Shuldiner AR, Skaar T, Tyndale RF, Weinshilboum RM, Weiss ST, Zineh I for the Pharmacogenetics Research Network. The Pharmacogenetics Research Network: From SNP Discovery to Clinical Drug Response. Clin Pharmacol Ther 2007;81:328-345.

83. Beitelshees AL, Gong Y, Wang D, Schork NJ, Cooper-DeHoff RM, Langaee TY, Shriver MJ, Sadee W, Knot HJ, Pepine CJ, Johnson JA, for the INVEST Investigators. KCNMB1 genotype influences response to verapamil and adverse outcomes in the INternational VErapamil SR/Trandolapril STudy (INVEST). KCNMB1 genotype influences response to verapamil and adverse outcomes in the INternational VErapamil SR/Trandolapril STudy (INVEST). Pharmacogenetic Genom 2007;17:719- 729.

84. Shin J, Johnson JA. Beta-blocker pharmacogenetics. (Invited review). Pharmacotherapy 2007;27:874-887.

85. Brunner M, Cooper-DeHoff RM, Gong Y, Karnes JH, Langaee TY, Pepine CJ, Johnson JA.. Factors influencing blood pressure response to ACE inhibitor add-on therapy in patients of the International Verapamil SR/Trandolapril Study (INVEST). Am J Cardiol 2007;99:1549-54.

86. Pacanowski MA, Johnson JA. PharmGKB submission update: IX. ADRB1 Gene Summary. Pharmacol Rev 2007;59:2-4.

87. Lin M, Hou W, Li HY, Johnson JA and Wu RL. Modeling interactive quantitative trait nucleotides for drug response. Bioinformatics 2007;23:1251-7.

88. Levin GM, Bowles TM, Ehret MJ, Langaee TY, Tan JY, Johnson JA, Millard WJ. Assessment of human serotonin 1A receptor polymorphisms and SSRI responsiveness. Mol Diag Ther 2007;11:155-160.

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89. Shin J, Kline S, Moore M, Gong Y, Bhanderi V, Schmalfuss CM, Johnson JA, Schofield RS. Association of Diurnal Blood Pressure Pattern with Risk for Hospitalization or Death in Men with Heart Failure. J Card Failure 2007;13:656-662.

90. Aquilante CL, Cavallari LH, Yarandi HN, Andrisin TE, Terra SG, Lewis JF, Hamilton KK, Johnson JA. Beta-adrenergic receptor polymorphisms and response to dobutamine during dobutamine stress echocardiography. Pharmacogenom J 2007, in press.

91. Johnson JA, Moore MJ, Shin J, Frye RF. Fostering PharmD student interest in research through a formalized summer research training program. Am J Pharm Ed 2007; in press.

92. Shin J, Johnson JA. Beta-blocker pharmacogenetics in heart failure. (Invited Review) Heart Fail Rev 2007, in press.

93. Gerhard T, Gong Y, Beitelshees AL, Lobmeyer M, Cooper-DeHoff RM, Langaee TY, Shriver MD, Schork NJ, Pepine CJ, Johnson JA, for the INVEST Investigators. Association between Cardiovascular Outcomes, Diuretic Therapy and the α-adducin Polymorphism: Results from the INternational VErapamil SR-trandolapril STudy GENEtic Substudy (INVEST-GENES). Submitted for publication, 2007.

94. Gong Y, Handberg EM, Gerhard T, Cooper-DeHoff RM, Ried DL, Johnson JA, Pepine CJ. Association of systolic blood pressure and health related quality of life in patients with coronary artery disease: An analysis from the International Verapamil SR-trandolapril Study (INVEST). Submitted for publication, 2007.

95. Dungan JR, Langaee TY, Conley YP, Johnson JA, Kneipp SM, Hess PJ, Yucha CB. Differential alpha1A- and beta2-adrenergic receptor gene expression in clinical hypertension. Submitted for publication, 2007.

96. Weiss ST, McLeod HL, Flockhart DA, Dolan E, Benowitz NL, Johnson JA, Ratain MJ, Weinshilboum RM, Giacomini KM on behalf of the Pharmacogenetics Research Network Investigators. Diagnostic testing in pharmacogenetics: Standards for creating and evaluating genetic tests predictive of drug effects in the era of genomic medicine: A guide for clinicians. Submitted for publication, 2007.

97. Gong Y, Beitelshees AL, Langaee TY, Cooper-DeHoff RM, Pepine CJ, Johnson JA. β2-adrenergic receptor polymorphisms are associated with response to β-blocker therapy: Results from the INVEST Genetic Substudy (INVEST-GENES). Submitted for publication, 2007.

98. Gage BF, Eby C, Johnson JA, Rieder MJ, Ridker PM, Rettie AE, Aquilante CL, Milligan PE, Deych E, Grosso L, Marsh S, Langaee TY, Farnett LE, Voora D, Veenstra DL, Glynn R, McLeod HL. Use of pharmacogenetics and clinical factors to predict the therapeutic dose of warfarin. Submitted for publication, 2007.

99. Hassan M, York KM, Li H, Li Q, Gong Y, Langaee TY, Fillingham RB, Johnson JA, Sheps DS. Β1- adrenergic receptor polymorphism predicts hemodynamic and myocardial ischemia responses to mental stress in patients with coronary artery disease. Submitted for publication, 2007.

100. Langaee TY, Burkley B, Feng H, Johnson JA, Stacpoole PW. Inter-population variation frequency of human zeta-class glutathione transferase polymorphisms and kinetic differences in biotransformation of dichloroacetate. Submitted for publication, 2007.

101. Lima JJ, Mohapatra S, Feng H, Lockey R, Jones A, Castro M, Irvin C, Johnson JA, Wang J, Sylvester JE. A polymorphism in the NPPA genetic associates with asthma. Submitted for publication, 2007. Julie A. Johnson Curriculum Vitae - Page 14

Editorials and Letters to the Editor

102. Johnson JA. Improving cardiovascular drug therapy through pharmacogenomics? Hellenic J Cardiol 2002;43:16-19.

103. Johnson JA. -blockers in heart failure: Will we someday select therapy based on genetics? Pharmacogenetics 2003;13:375-77.

104. Johnson JA. Use of pharmacogenetics in clinical medicine: Hype or hope? Personalized Med 2005;2:279-282.

105. Gerhard T, Beitelshees AL, Johnson JA. Letter to the Editor RE: Meckley LM, Veenstra DL. Screening for the alpha-adducin Gly460Trp variant in hypertensive patients: a cost effectiveness analysis. Pharmacogenet Genom 2006;16:613.

Book chapters

106. Johnson JA, Lalonde RL. Congestive Heart Failure. In: DiPiro JT, Talbert RL, Hayes PE, Yee GC, Posey LM (eds). Pharmacotherapy A Pathophysiologic Approach, 2nd Edition. Appleton & Lange: Norwalk, Connecticut. 1992, pp. 160-193.

107. Sowinski KM, Johnson JA. Angina Pectoris. In Herfindal ET, Gourley DR (eds). Textbook of Therapeutics, 6th Edition. Williams & Wilkins: Baltimore, Maryland. 1996:811-828.

108. Johnson JA, Lalonde RL. Congestive Heart Failure. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM (eds). Pharmacotherapy A Pathophysiologic Approach, 3rd Edition. Appleton & Lange: Norwalk, Connecticut. 1997, pp. 219-256.

109. Johnson JA, Parker RB, Geraci SA. Heart Failure. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG,Posey LM (eds). Pharmacotherapy A Pathophysiologic Approach, 4th Edition. Appleton & Lange: Norwalk, Connecticut, 1999, pp.153-181.

110. Johnson JA, Parker RB, Patterson JH. Heart Failure. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG,Posey LM (eds). Pharmacotherapy A Pathophysiologic Approach, 5th Edition. McGraw Hill: New York, New York, 2002, pp.185-218.

111. Johnson JA. Drug target pharmacogenetics. In: Pharmacogenomics – Applications to Patient Care. ACCP: Kansas City, Missouri, 2004, pp. 337-376.

112. Johnson JA, Cavallari LH. Cardiovascular pharmacogenomics. In: Raizada MK, Paton JFR, Kasparov S, Katovich MJ (eds). Cardiovascular Genomics. Humana Press, Inc: Totowa, NJ, 2005, pp. 71-93.

113. Parker RB, Patterson JH, Johnson JA,. Heart Failure. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG,Posey LM (eds). Pharmacotherapy A Pathophysiologic Approach, 6th Edition. McGraw Hill: New York, New York, 2005, pp. 219-260.

114. Johnson JA, Zineh I. Cardiovascular Pharmacogenomics and Personalized Medicine. In: Liew CC, Dzau V (eds). Cardiovascular Genetics and Genomics for the Cardiologist. Blackwell Publishing: Oxford, England. 2007, pp. 250-276.

Julie A. Johnson Curriculum Vitae - Page 15

115. Johnson JA, Zineh I, Pacanowski MA. Pharmacogenetics and Pharmacogenomics. In: Roden DM (ed). Cardiovascular Genetics and Genomics. Blackwell Publishing: Oxford, England. 2008, in press.

Peer-reviewed electronic publications

116. Pacanowski MA, Johnson JA. Annotated pharmacogenetic gene information for the β1-adrenergic receptor gene (ADRB1). http://www.pharmgkb.org/search/annotatedGene/adrb1/ and http://www.pharmgkb.org/search/annotatedGene/adrb1/.

117. Litonjua A, Shin J, Johnson JA, Weiss ST. Annotated pharmacogenetic gene information for the β2-adrenergic receptor gene (ADRB2). http://www.pharmgkb.org/search/annotatedGene/adrb2/ and http://www.pharmgkb.org/search/annotatedGene/adrb2/variant.jsp.

118. Schentrup AM, Lima JJ, Johnson JA. Annotated pharmacogenetic gene information for the arachidonate 5-lipoxygenase gene (ALOX5). http://www.pharmgkb.org/search/annotatedGene/alox5/index.jsp and http://www.pharmgkb.org/search/annotatedGene/alox5/variant.jsp.

119. Bushwitz J, Pacanowski MA, Johnson JA. Annotated pharmacogenetic gene information for the coagulation factor 5 gene (F5). http://www.pharmgkb.org/search/annotatedGene/f5/index.jsp and http://www.pharmgkb.org/search/annotatedGene/f5/ImportantVariantInformationforF5.jsp.

120. Gonzales D, Pacanowski MA, Johnson JA. Annotated pharmacogenetic gene information for the potassium inwardly-rectifying channel, subfamily J, member 11 (KCNJ11). http://www.pharmgkb.org/search/annotatedGene/kcnj11/index.jsp and http://www.pharmgkb.org/search/annotatedGene/kcnj11/ImportantVariantInformationforKCNJ11.jsp

Abstracts (since 2000)

37. Humma LM, B. Nhi Nguyen, Farmerie WG, Wallace MR, Johnson JA. 2-adrenoceptor polymorphisms are associated with nocturnal blood pressure decline in hypertensives. J Am Coll Cardiol 2000;35:333A. Presented at the 49th Annual Scientific Session of the American College of Cardiology, Anaheim, CA, March 2000.

38. Humma LM, Richardson HE, Lewis JF, Pepine CJ, Johnson JA. Dobutamine pharmacodynamics. Clin Pharmacol Ther 2000;67:117. Presented at the 101st Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Los Angeles, CA, March 2000.

39. Lima JJ, Nguyen BNT, Parker RB, Johnson JA. Clin Pharmacol Ther 2000;67:125. Chronopharmacodynamic model of S-verapamil evoked antihypertensive effects. Presented at the 101st Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Los Angeles, CA, March 2000.

40. Tuteja S, Alloway RR, Meier-Kriesche HU, Streetman DS, Johnson JA, Gaber AO. The effect of gender on ketoconazole induced changes in tacrolimus pharmacokinetics. Transplantation 2000;69 (Suppl):S163. Presented at the First Joint Annual Meeting of the American Society of Transplant Surgeons and the American Society of Transplantation, Chicago, IL, May 2000.

41. Humma LM, Richardson HE, Puckett BJ, Lejeune BL, Farmerie WG, Wallace MG, Lewis JF, McNamara DM, Pepine CJ, Johnson JA. Functional significance of 1-adrenergic receptor polymorphisms in humans. J Cardiac Failure 2000;6 (Suppl 2):29. Presented at the 4th Annual Scientific Meeting of the Heart Failure Society of America, Boca Raton, FL, September 2000.

Julie A. Johnson Curriculum Vitae - Page 16

42. Puckett BJ, Humma LM, Lejeune BL, Lewis JF, Pepine CJ, Johnson JA. Effects of -adrenoceptor polymorphisms on resting hemodynamics and dobutamine response in humans. Pharmacotherapy 2000;20:1262. Presented at the 21st Annual Meeting of the American College of Clinical Pharmacy, Los Angeles, CA, November 2000. ** First runner up in the Best Poster Competition for Students, Residents and Fellows.

43. Humma LM, Nguyen BNT, Wallace MR, Farmerie WG, Johnson JA. 1- and 2-adrenergic receptor polymorphisms and diurnal blood pressure variation. Pharmacotherapy 2000;20:1263. Presented at the 21st Annual Meeting of the American College of Clinical Pharmacy, Los Angeles, CA, November 2000. ** Winner in the Best Poster Competition for Students, Residents and Fellows and Runner-up in Best Overall Poster Competition.

44. Humma LM, Puckett BJ, Lejeune BL, McNamara DM, Pepine CJ, Johnson JA. 1-adrenergic receptor polymorphisms and obesity. Clin Pharmacol Ther 2001;69:P63. Presented as a platform presentation at the 102nd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Orlando, FL, March 2001.

45. Wang J, Humma L., Mougey E., CJ David, Johnson JA, Lima JJ,Sylvester J. Determination of 2- adrenergic receptor haplotype by denaturation selective amplification and subtractive genotyping. Amer J Hum Genet 2001;69:542. Presented at the Annual Meeting of the American Society of Human Genetics, San Diego, California, October 2001.

46. Puckett BJ, Pauly DF, Zineh I, Johnson JA. -adrenergic receptor polymorphisms and antihypertensive response to -blocker therapy. Clin Pharmacol Ther 2002;71:P2. Presented as a platform presentation at the 103rd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Atlanta, GA, March 2002. Awarded the ASCPT Presidential Trainee Award for outstanding trainee abstract.

47. Terra SG, McGorray SP, Wallace MR, Picoult-Newberg L, Pepine CJ, Johnson JA. Linkage

disequilibrium of common 1-adrenergic receptor polymorphisms. Clin Pharmacol Ther 2002;71:P70. Presented at the 103rd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Atlanta, GA, March 2002.

48. Aquilante CL, Humma LM, Andrisin TE, Lejeune BL, Lewis JF, Johnson JA. The influence of gender and race on pharmacodynamic response to dobutamine during dobutamine stress echocardiography. Clin Pharmacol Ther 2002;71:P80. Presented at the 103rd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Atlanta, GA, March 2002.

49. Puckett BJ, Pauly DF, Zineh I, Johnson JA. -blockers decrease heart rate and inhibit exercise tachycardia regardless of antihypertensive effect. Pharmacotherapy 2002;22:407. Presented at the 2002 Spring Practice and Research Forum of the American College of Clinical Pharmacy, Savannah, GA, April 2002.

50. Aquilante CL, Humma LM, Terra SG, Andrisin TM, Lewis JF, Hamilton KK, Walker J, Picoult- Newberg L, Johnson JA. Adrenergic Receptor Polymorphisms and Response to Dobutamine. Pharmacotherapy 2002; 22:240. Presented at the 23rd Annual Meeting of the American College of Clinical Pharmacy, Albuquerque, New Mexico, October 2002.

51. Zineh I, Puckett BJ, McGorray SP, Pauly DF, Johnson JA. 1-adrenergic receptor polymorphisms predict antihypertensive response to -blockers. Circulation 2002;106(19, Suppl 2):II-574. Presented at the American Heart Association Scientific Sessions, Chicago, IL, November 2002.

52. Zineh I, Puckett BJ, Pauly DF, McGorray SP, Johnson JA. Beta-1 adrenoreceptor gene haplotypes and antihypertensive response to beta-blocker therapy. Clin Pharmacol Ther 2003;73(2):P97. Presented as a moderated poster at the 104th Annual Meeting of the American Julie A. Johnson Curriculum Vitae - Page 17

Society for Clinical Pharmacology and Therapeutics, Washington, D.C., April 2003. *Awarded the ASCPT Presidential Trainee Award for outstanding trainee abstract.

53. Beitelshees AL, Zineh I, Yarandi HN, Puckett BJ, Pauly DF, Johnson JA. Contribution of Gs and

2AR polymorphisms to antihypertensive response to -blockers. Clin Pharmacol Ther 2003;73(2):P98. Presented as a moderated poster at the 104th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Washington, D.C., April 2003.

54. Beitelshees AL, Zineh I, Parangi HN, Puckett BJ, Langaee TY, Pauly DF, Johnson JA. Utility of clinic versus ambulatory blood pressure for pharmacogenetic studies. Pharmacotherapy 2003;23:1356. Presented at the American College of Clinical Pharmacy Annual Meeting, Atlanta, GA, November 2003.

55. Zineh I, Beitelshees AL, Walker JR, Puckett BJ, Pauly DF, Phillips MS, Gellan CA, Johnson JA. Impact of Cytochrome P450 2D6 genotypes on metoprolol response rate and adverse effects among hypertensive. Pharmacotherapy 2003;23:1356. Presented at the American College of Clinical Pharmacy Annual Meeting, Atlanta, GA, November 2003.

56. Aquilante CL, Yarandi HN, Langaee TY, Tromberg JS, Lopez LM, Waddell CD, Johnson JA. The influence of coagulation factor and CYP2C9 polymorphisms on warfarin dose. Circulation 2003;108:IV-424. Presented at the 2003 Scientific Sessions of the American Heart Association. Orlando, Florida, November 2003.

57. Zineh I, McGorray SP, Jernigan LL, McNamara DM, Pauly DF, Bairey Merz CN, Pepine CJ, Johnson JA. Influence of genetic and non-genetic factors on endothelium-dependent microvascular reactivity in the NHLBI-sponsored Women’s Ischemia Syndrome Evaluation (WISE). J Am Coll Cardiol 2004;43(5):452A. Presented at the 2004 Annual Meeting of the American College of Cardiology, New Orleans, Louisiana, March 2004.

58. Zineh I, McGorray SP, Jernigan LL, McNamara DM, Pauly DF, Bairey Merz CN, Pepine CJ, Johnson JA. Relationship between b-adrenergic system polymorphisms and coronary peak flow velocity ratio in women: analysis from the NHLBI-sponsored Women’s Ischemia Syndrome Evaluation (WISE). J Am Coll Cardiol 2004;43(5):253A. Presented at the 2004 Annual Meeting of the American College of Cardiology, New Orleans, Louisiana, March 2004.

59. Beitelshees AL, Zineh I, Gaedigk A, Leeder JS, Walker JR, Eberst K, Timmerbeil BS, Lobmeyer M, Pauly DF, Johnson JA. Effect of CYP2D6 phenotype and metoprolol pharmacokinetics on adverse effects. Clin Pharmacol Ther 2004;75(2):P95. Presented as a moderated poster at the 105th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Miami, Florida, March 2004.

60. Rantinella RP, Zineh I, Potvin ML, Yarandi HN, Sloan AJ, Pauly DF, Johnson JA. Consideration of beta-1 adrenergic receptor polymorphisms along with traditional risk factors as predictors of prognosis in patients with heart failure. Clin Pharmacol Ther 2004;75(2):P55. Presented at the 105th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Miami, Florida, March 2004.

61. Beitelshees AL, Cavallari LH, Gaston KG, Okorochukwu TU, Johnson JA. Beta1-adrenergic receptor polymorphisms and hypertension. Clin Pharmacol Ther 2004;75(2):P61. Presented at the 105th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Miami, Florida, March 2004.

62. Terra SG, Hamilton KK, Pauly DF, Lee CR, Patterson JH, Adams KF, Schofield RS, Hill JA, Aranda JM, Yarandi HN, Johnson JA. Arg389Gly 1-adrenergic receptor polymorphism and left ventricular remodeling changes to -blocker therapy. Clin Pharmacol Ther 2004;75:P2. Presented at the 105th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Miami, Julie A. Johnson Curriculum Vitae - Page 18

Florida, March 2004. *Awarded the ASCPT Presidential Trainee Award for outstanding trainee abstract.

63. Terra SG, Pauly DF, Lee CR, Patterson JH, Adams KF, Schofield RS, Hamilton KK, Hill JA, Aranda JM, Yarandi HN, Johnson JA. Effect of the 1-adrenergic receptor polymorphisms on the tolerability of metoprolol CR/XL in heart failure. Clin Pharmacol Ther 2004;75:P16. Presented at the 105th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Miami, Florida, March 2004.

64. Langaee TY, Givens RC, Sloan A, Watkins PB, Johnson JA. Association of CYP3A5 *3, *6, and *7 polymorphisms with hypertension. Clin Pharmacol Ther 2004;75:P13. Presented at the 105th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Miami, Florida, March 2004.

65. Belgado BS, Cavallari LH, Langaee TY, Okorochukwu T, Sloan A, Johnson JA. Association of the

2-adrenergic receptor ( 2AR) haplotype and hypertension in African Americans and Caucasians. Association of CYP3A5 *3, *6, and *7 polymorphisms with hypertension. Clin Pharmacol Ther 2004;75:P95. Presented at the 105th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Miami, Florida, March 2004.

66. Zineh I, Luo X, Langaee TY, Johnson JA, Chegini N. Th1- and Th2-related cytokine and chemokine balance in blood pressure responders and non-responders to metoprolol monotherapy. Pharmacotherapy 2004;24:1427. Presented at the 25th Annual meeting of the American College of Clinical Pharmacy, Dallas, Texas, October 2004.

67. Gaston KL, Aquilante CL, Langaee TY, Lopez LM, Johnson JA. Vitamin K epoxide reductase polymorphisms rare in warfarin-treated population. Pharmacotherapy 2004; 24:1458 Presented 25th Annual Meeting of the American College of Clinical Pharmacy Annual Meeting, Dallas, Texas, October 2004.

68. Beitelshees AL, Langaee TY, Johnson JA. SNP discovery using denaturing HPLC for the CACNA1C gene. Pharmacotherapy 2004;24:1458. Presented at the 25th Annual meeting of the American College of Clinical Pharmacy, Dallas, Texas, October 2004. First runner-up in Best Student, Resident and Fellow Poster competition.

69. Hudson AA, Zineh I, Yarandi HN, Langaee TY, Pauly DF, Johnson JA. Angiotensin system polymorphisms and traditional risk factors as predictors of heart failure prognosis. Clin Pharmacol Ther 2005;77:P63. Presented at the 106th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Orlando, Florida, March 2005.

70. Beitelshees AL, Gong Y, DeHoff RM, Moss JI, Pepine CJ, Johnson JA. Variable blood pressure response to verapamil by KCNMB1 genotype. Clin Pharmacol Ther 2005;77:P97. Presented at the 106th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Orlando, Florida, March 2005.

71. Gong Y, Beitelshees AL, Stauffer L, Gaston K, Sloan A, Yarandi HN, Langaee TY, DeHoff RM, Pepine CJ, Johnson JA. Beta2-adrenergic receptor polymorphisms and antihypertensive response to -blocker therapy in the INVEST trial. Clin Pharmacol Ther 2005;77:P22. Presented at the 106th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Orlando, Florida, March 2005.

72. Gerhard T, Gong Y, Beitelshees AL, Lobmeyer M, Schiefelbein L, Langaee TY, Cooper-Dehoff RM, Johnson JA. Association between CV Outcomes, Diuretic Use and the α-adducin Gene: Results from the International VErapamil SR-Trandolapril Study (INVEST). Circulation. 2005;112(17):SII- 608. Presented at the 2005 Scientific Sessions of the American Heart Association. November 2005. Julie A. Johnson Curriculum Vitae - Page 19

73. Gong Y, Beitelshees AL, Stauffer LA, Langaee TY, Cooper-DeHoff RM, Pepine CJ, Johnson JA, Beta adrenergic receptors polymorphisms are associated with response to beta-blocker therapy in the INternational VErapamil SR-Trandolapril Study (INVEST). Clin Pharmacol Ther 2006;79:P30. Presented as a podium presentation at the 107th Annual meeting of the American Society for Clinical Pharmacology and Therapeutics, Baltimore, MD, March 2006. *Awarded the ASCPT Presidential Trainee Award for outstanding trainee abstract.

74. Langaee TY, Yarandi HN, Katz DA, Dehoff RM, Kehoe JM, Klocman AS, Pepine CJ, Johnson JA. Differences in verapamil response between CYP3A5 genotypes. Clin Pharmacol Ther 2006;79(2):P12. Presented at the 107th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Baltimore, Maryland, March 2006.

75. Brunner M, Karnes JH, Gong Y, Langaee TY, Cooper-DeHoff RM, Pepine CJ, Johnson JA. Association of angiotensin II type I receptor (AGTR1) 1166A>C polymorphism with blood pressure response to ace inhibitor in a subgroup of patients of the International Verapamil CR/trandolapril Study (INVEST). Clin Pharmacol Ther 2006;79(2):P14. Presented at the 107th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Baltimore, Maryland, March 2006.

76. Kroetz DL, Yu Z, Langaee TY, Johnson JA. Functionally significant variants of CYP2J2 and EPHX2 are not associated with hypertension. Clin Pharmacol Ther 2006;79(2):P15. Presented at the 107th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Baltimore, Maryland, March 2006.

77. Shin J, Lobmeyer MT, Gong Y, Zineh I, Langaee TY, Yarandi HN, Pauly DF, Aranda JM, Schofield RS, Hill JA, Johnson JA. A haplotype of β2-adrenoceptor is associated with the increased risk for transplant or death in heart failure patients. Clin Pharmacol Ther 2006;79(2):P30. Presented as a podium presentation at the 107th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Baltimore, Maryland, March 2006. *Awarded the ASCPT Presidential Trainee Award for outstanding trainee abstract.

78. Lobmeyer MT, Terra SG, Gong Y, Hamilton KK, Pauly DF, Patterson JH, Adams Jr. KF, Schofield RS, Hill JA, Aranda JM, Johnson JA. Synergistic polymorphisms of β1- and 2C-adrenergic receptors and the influence on left ventricular ejection fraction in response to β-blocker therapy in heart failure. Clin Pharmacol Ther 2006;79(2):P31. Presented as a podium presentation at the 107th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Baltimore, Maryland, March 2006. *Awarded the ASCPT Presidential Trainee Award for outstanding trainee abstract.

79. Beitelshees AL, Gong Y, Cooper-DeHoff RM, Burt L, Stauffer LA, Pepine CJ, Johnson JA. KCNMB1 genotype associated with cardiovascular outcomes in the International Verapamil SR/trandolapril Study (INVEST). Clin Pharmacol Ther 2006;79(2):P41. Presented at the 107th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Baltimore, Maryland, March 2006.

80. Johnson JA, Karnes JH, Brunner M, Gong Y, Langaee TY, Cooper-DeHoff RM, Pepine CJ. Lack of association of the angiotensin II type I receptor (AGTR1) 1166A>C polymorphism with cardiovascular and cerebrovascular outcomes in a subgroup of patients of the International Verapamil SR/trandolapril Study (INVEST. Clin Pharmacol Ther 2006;79(2):P43. Presented at the 107th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Baltimore, Maryland, March 2006.

81. Shin J, Kline S, Moore M, Gong Y, Bhanderi V, Schmalfuss CM, Schofield RS, Johnson JA. Diurnal blood pressure pattern is associated with risk for hospitalization or death in heart failure. Julie A. Johnson Curriculum Vitae - Page 20

Clin Pharmacol Ther 2007;81:S15. Presented at the 108th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Anaheim, California, March 2007.

82. Pacanowski MA, Gong Y, Langaee TY, Cooper-DeHoff RM, Schork NJ, Pepine CJ, Johnson JA. Β2-adrenergic receptor polymorphisms and antihypertensive treatment outcomes in the International Verapamil SR/Trandolapril Study-Genetic Substudy (INVEST-GENES). Clin Pharmacol Ther 2007;81:S34. Presented at the 108th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Anaheim, California, March 2007.

83. Schentrup AM, Nino G, Gong Y, Lima JJ, Cooper-DeHoff RM, Pepine CJ, Johnson JA. LTA4H variant confers drug therapy-dependent reduced risk of cardiovascular events in INVEST (International Verapamil SR/Trandolapril Study). Clin Pharmacol Ther 2007;81:S35. Presented at the 108th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Anaheim, California, March 2007.

84. Gerhard T, Winterstein AG, Shuster, JJ, Johnson, JA, Hartzema AG, Pepine CJ. Estimating Effects of Antihypertensive Therapy on Adverse Outcomes in the Presence of Time-Dependent Confounding by Blood Pressure. Pharmacoepidemiology and Drug Safety, 2007; 16:S32. Presented at the 2007 Annual Meeting of the International Society for Pharmacoepidemiology (ISPE) in Quebec City, Quebec, August 2007.

85. Gerhard T, Winterstein AG, Shuster, JJ, Johnson, JA, Hartzema AG, Pepine CJ. Impact of Operationalizion of Longitudinal Blood Pressure on Adverse Outcomes. Pharmacoepidemiology and Drug Safety, 2007; 16:S115. Presented at the 2007 Annual Meeting of the International Society for Pharmacoepidemiology (ISPE) in Quebec City, Quebec, August 2007.

86. Gerhard T, Winterstein AG, Shuster, JJ, Johnson, JA, Hartzema AG, Pepine CJ. Use of Average Surrogate Values Introduces Bias: A Simple Simulation. Pharmacoepidemiology and Drug Safety, 2007; 16:S115-116. Presented at the 2007 Annual Meeting of the International Society for Pharmacoepidemiology (ISPE) in Quebec City, Quebec, August 2007.

INVITED PRESENTATIONS since 2000

“Impact of 2-adrenergic Receptor Polymorphisms on Drug Response and Cardiovascular Disease”. 101st Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Los Angeles, CA, March 2000.

“Mock Study Section: Industry, Foundation and Federal Grants”. 2000 Spring Practice and Research Forum – American College of Clinical Pharmacy, Monterey, CA, April 2000.

“Drug Target Pharmacogenomics – Current and Future Approaches” IBC USA’s 3rd Annual Pharmacogenomics, SNPs and Genetic Patenting Conference, San Diego, CA, February 2001.

“Treatment of Chronic Heart Failure” North Carolina Society of Hospital Pharmacists Annual Meeting, Greensboro, NC, March 2001.

“Drug Target Pharmacogenomics”. American Pharmaceutical Association 148th Annual Meeting, San Francisco, CA, March 2001.

“ -adrenoceptor Polymorphisms and Cardiovascular Pharmacogenetics”. University of California at San Francisco, Pharmacogenomics and Biopharmaceutical Sciences Seminar Series, San Francisco, California, March 2001.

Julie A. Johnson Curriculum Vitae - Page 21

“ -adrenoceptor Polymorphisms: Cardiovascular Disease and Pharmacogenetics”. Ohio State University Heart Lung Research Institute Lecture, Columbus, Ohio, July 2001.

“Pharmacogenomics: Impact on Pharmacy and Medicine”. Keynote Address, Florida Society of Hospital Pharmacists Annual Meeting, Orlando, Florida, August 2001.

“Pharmacogenetics”. Florida Medical Association Annual Meeting. Miami, Florida, September 2001.

“Drug Target Pharmacogenetics”. 2001 Annual Meeting – American College of Clinical Pharmacy. Tampa, Florida, October 2001.

“Shifting the Paradigm in Decompensated Heart Failure: Treating Pathophysiology versus Symptoms. 2001 Annual Meeting – American College of Clinical Pharmacy. Tampa, Florida, October 2001.

“Neurohormonal Paradigm of Heart Failure” 2001 Midyear Clinical Meeting, American Society of Health-System Pharmacists, New Orleans, Louisiana, December 2001

“ -adrenergic receptor polymorphisms and pharmacogenetics” Clinical Pharmacology Seminar Series, Indiana University, Indianapolis, Indiana, February 2002.

“Clinical Applications of Pharmacogenomics” Johnson & Johnson Pharmacogenomics Symposium, Johnson & Johnson World Headquarters, New Brunswick, New Jersey, February, 2002.

” -blocker pharmacogenetics” Molecular Pharmacology and Experimental Therapeutics Seminar Series, Mayo Clinic, Rochester, Minnesota, May 2002.

“Pharmacogenomics: Moving from proof of concept to clinical practice” NIH/NHLBI Workshop on Genetic Determinants of Response to Drug Therapies in Heart Failure, Bethesda, Maryland, September 2002

“Pharmacogenetics of Cardiovascular Drugs”, New York Academy of Medicine 2002 Basic Science Symposium: Pharmacogenetics: From Bench to Bedside, New York, New York, October 2002.

“Drug Target Pharmacogenomics: Complexity of the drug response”, Institut Pasteur Euroconferences and New England Journal of Medicine: Pharmacogenomics: The Promise and Reality of Individualized Treatment, Paris, France, October 2002.

“ -blocker pharmacogenetics”. Philip C. and Ethel F. Ashby Lecture Series, University of Oklahoma College of Pharmacy, Oklahoma City, Oklahoma, February 2003.

“ -blocker pharmacogenetics”. Pfizer, Inc. Visiting Professor, Ann Arbor, Michigan, March 2003

“ -blocker pharmacogenetics”. Department of Clinical Pharmacy Seminar Series, University of Michigan, Ann Arbor, Michigan, March 2003.

“Racial/ethnic differences in pharmacokinetics and drug response”. Public Policy Forum, American Society for Clinical Pharmacology and Therapeutics 104th Annual Meeting, Washington, DC, April 2003.

“ -blocker pharmacogenetics”. Louis Ebert Memorial Rho Chi Lecture, University of Illinois, Chicago, Illinois, April 2003.

“Hypertension pharmacogenetics”. NIH National Institute on Aging Gerontology Research Center Seminar, Baltimore, Maryland, May 2003.

Julie A. Johnson Curriculum Vitae - Page 22

“Moving pharmacogenomics to clinical practice”. NIH, NHLBI Working Group on Polymorphisms of the -adrenergic Receptor Gene: Implications for the Pharmacotherapy of Asthma. Washington, DC, June 2003.

“ -blocker pharmacogenetics”. Visiting Professor Lecture Series, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, July 2003.

“Pharmacogenomics: The Promise of Personalized Medicine”. 32nd Annual Meeting of the American College of Clinical Pharmacology. Tampa, Florida, September 2003.

“Employing pharmacogenetics to optimize pharmacotherapeutics outcomes”. 2003 Annual Meeting of the American College of Clinical Pharmacy. Atlanta, Georgia, November, 2003.

“Understanding variable -blocker response: From pharmacokinetics to pharmacogenetics”. American Society for Clinical Pharmacology and Therapeutics Leon I. Goldberg Young Investigator Award Lecture, 105th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Miami, Florida, March 2004.

“Pharmacogenomics: Genetically-guided therapy and potential impact on adherence”. 2nd Scientific Conference on Compliance in Healthcare and Research, American Heart Association, Washington D.C. May 2004.

“Pharmacogenomics: The Promise of Personalized Medicine through Genetics”. 7th Annual Pharmacogenetics and Medicine Lectures: From Bench to Bedside: Developing Innovative Therapies in the Age of Pharmacogenomics. Yale University School of Medicine and Genaissance Pharmaceuticals, New Haven, Connecticut, May 2004.

“Impact of Genetics on PK/PD, Efficacy and Safety: Clinical Implications and Regulatory Requirements in the Pharmacogenomic Era”. Speaker and session moderator. American Association of Pharmaceutical Scientists Pharmacokinetics, Pharmacodynamics and Drug Metabolism Section Open Forum. Baltimore, MD, November 2004.

“ -blocker pharmacogenetics in hypertension and heart failure.” Ohio State University Department of Pharmacology and Program in Pharmacogenomics Seminar Series. Columbus, Ohio, December 2004.

“ -blocker pharmacogenetics in hypertension and heart failure.” University of Minnesota, Department of Clinical Pharmacy Seminar Series, Minneapolis, Minnesota, January 2005.

“ -blocker pharmacogenetics in hypertension and heart failure.” Medtronic Forum Visiting Professor, Medtronic, Inc. Minneapolis, Minnesota, January 2005.

“ -receptor polymorphisms and heart failure”. American College of Cardiology Annual Scientific Session, Orlando, Florida, March 2005.

“Drug target pharmacogenetics: A focus on -blockers”. American Society for Experimental Pharmacology and Therapeutics Annual Meeting, San Diego, California, April 2005.

“Establishing and maintaining a research program”. American College of Clinical Pharmacy Spring Forum, Myrtle Beach, South Carolina, April 2005.

“ -blocker pharmacogenetics in hypertension and heart failure.” Cornell University Department of Pharmacology Seminar Series, New York, New York, May 2005.

“Cardiovascular drug pharmacogenetics: Potential clinical implication.” Cornell University College of Medicine Advanced Basic Sciences Course guest lecturer, New York, New York, May 2005. Julie A. Johnson Curriculum Vitae - Page 23

“Pharmacogenetics and Behavioral Medicine”. Behavioral Genetics and Cardiovascular Disease Workshop, National Heart Lung Blood Institute, NIH. Bethesda, Maryland, August 2005.

“ -blocker pharmacogenetics in hypertension and heart failure.” Rennebohm Symposium, University of Wisconsin, Madison, Wisconsin, September 2005.

“Pharmacogenomics – the promise of personalized medicine”. David Guttman Memorial Lecture, University of Kentucky College of Pharmacy, Lexington, Kentucky, September 2006.

“Hypertension Pharmacogenomics”. University of Kentucky College of Pharmacy Research Seminar, Lexington, Kentucky, September 2006.

“Cardiovascular Pharmacogenomics”. American Heart Association 2006 Scientific Sessions, Chicago, Illinois, November 2006.

“Personalized Medicine: The Promise of Pharmacogenomics”. Plenary Session, American Heart Association 2006 Scientific Sessions; session organizer and moderator. Chicago, Illinois, November 2006.

“Cardiovascular Pharmacogenetics and the Unique Perspective of the Clinical Pharmaceutical Scientist”. NIH Conference on PharmD Pathways to Biomedical Research. Bethesda, Maryland, December 2006.

“Hypertension Pharmacogenetics – Clinical Potential and Challenges” 108th Scientific meeting of the American Society for Clinical Pharmacology and Therapeutics, Anaheim, California, March 2007.

“Genetic and Genomic Markers of Response to Antihypertensive Therapy. American Society for Pharmacology and Experimental Therapeutics Annual Meeting, Washington DC, April 2007.

“Hypertension pharmacogenetics: Academic pursuit or clinical paradigm shift?” University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania, May 2007. “Pharmacogenetics” American Thoracic Society International Conference, San Francisco, California, May 2007.

“Beta-adrenoceptor polymorphisms and drug response” XIX World Congress of the International Society for Heart Research, Bologna, Italy, June 2007.

“Pharmacogenomics: Pipedream or Clinical Reality?” Closing Science Plenary. American Association of Colleges of Pharmacy Annual Meeting, Orlando, Florida, July 2007

INVITED PRESENTATIONS – UNIVERSITY OF FLORIDA (NON COLLEGE OF PHARMACY)

“Pharmacogenetics” – Genetics Institute Seminar Series, March 2003

“Cardiovascular pharmacogenetics” – Cardiology Grand Rounds, Division of Cardiovascular Medicine, May 2005

“Hypertension pharmacogenetics and the Pharmacogenomic Evaluation of Antihypertensive Responses study” – Family Medicine Grand Rounds, Division of Community Health and Family Medicine, August 2005

“Hypertension pharmacogenetics” – Nephrology Grand Rounds, Division of Nephrology, May 2006

Julie A. Johnson Curriculum Vitae - Page 24

“Hypertension pharmacogenetics” – Cardiology Grand Rounds, Division of Cardiovascular Medicine, October 2006.

“Pharmacogenomics” – Florida Genetics, November 2006.

INVITED CONTINUING EDUCATION PRESENTATIONS since 1995

“Update on Treatment of Hypertension: JNC V”. St Mary’s Medical Center Regional Educational Conference, Duluth MN, March 1996.

“Update on Treatment of Hypertension”. Memphis Area Pharmacists Society, Memphis, TN, May 1997.

“Pathophysiology of Cardiovascular Disease”. University of Tennessee Cardiovascular Certificate Program. Presented in Nashville, Knoxville and Memphis, TN, October-November 1997.

“Clinical Considerations of Statin Therapy: Safety”. Cardiovascular Event Reduction: A Consultant’s Conference, White Sulphur Springs, WV and Boston, MA, June 1999; San Diego, CA, July 1999.

“ -blockers in Heart Failure: Standard of Care”. Continuing Education Program. Orlando, FL, October 2000; Lake Wales, FL, November 2000, Naples, FL, February 2001.

“Nesiritide in Decompensated Heart Failure”. Florida Society of Hospital Pharmacists Annual Meeting, Orlando, Florida, August 2001.

“Pharmacogenomics”. Ed Bates Memorial CE Program. Gainesville, Florida, April 2002.

“Pharmacogenomics”. Sponsored by Genetic Diagnostics, Inc., Atlanta, Georgia, November 2002.

“Hypertension Update 2004” UF College of Pharmacy Alumni Reunion Weekend CE Program, September 2004.

“Contemporary Management of Heart Failure” Ed Bates Memorial CE Program. Gainesville, Florida, September 2004.

“Genetics, Pharmacogenetics and the Human Genome” University of Florida CE Program, Alajuela, Costa Rica, June 2006

“Hypertension: Contemporary Pharmacotherapy and Pharmacogenetics” University of Florida CE Program, Alajuela, Costa Rica, June 2006

“Heart Failure Pharmacotherapy and Pharmacogenetics” University of Florida CE Program, Alajuela, Costa Rica, June 2006

“Dyslipidemias: Current treatment guidelines and Pharmacogenetics” University of Florida CE Program, Alajuela, Costa Rica, June 2006

“Clinical use of pharmacogenetics: Practical issues and potential ethical, legal and social implications: What does the practicing pharmacist need to know?” University of Florida CE Program, Alajuela, Costa Rica, June 2006

POST-DOCTORAL FELLOWS

Julie A. Johnson Curriculum Vitae - Page 25

Kevin M. Sowinski, Pharm.D., BCPS (State University of New York at Buffalo). July 1992 to June 1995. First position: Assistant Professor of Clinical Pharmacy, tenure track, Purdue University.

Wendell Scott Akers, Pharm.D., BCPS (University of Tennessee). July 1992 to July 1994. First position: Assistant Professor of Pharmacy Practice, tenure track, University of Kentucky.

Mohamad Haniki Nik Mohamed, Pharm.D. (University of Tennessee) July 1996 to October 1997. First position: Permanent Lecturer (equivalent to Assistant Professor), tenure track, School of Pharmaceutical Sciences, Universiti Sains Malaysia.

B. Nhi T. Nguyen, Pharm.D. (Philadelphia College of Pharmacy and Science). July 1997 to June 1999. First position: Pharmacokineticist/Reviewer, Food and Drug Administration, Center for Drug Evaluation and Research.

Larisa M. Humma, Pharm.D., BCPS (University of Georgia). July 1998 to December 2000. First position: Assistant Professor of Clinical Pharmacy, tenure track, University of Illinois, Chicago.

Brian J. Puckett, Pharm.D. (University of Texas). August 1999 to August 2001. First position: Assistant Professor of Clinical Pharmacy, tenure track, Medical College of Virginia – Virginia Commonwealth University.

Steven G. Terra, Pharm.D., BCPS (Northeastern University). July 2000 to June 2002. First position: Clinical Research Scientist, Cardiovascular/Metabolic Disease, Pfizer Global Research and Development.

Christina L. Aquilante, Pharm.D. (University of North Carolina at Chapel Hill). July 2001 to December 2003. First position: Assistant Professor of Clinical Pharmacy, tenure track, University of Colorado.

Issam Zineh, Pharm.D. (Northeastern University). July 2001 to December 2003. First position: Assistant Professor of Pharmacy Practice, tenure track, University of Florida College of Pharmacy.

Amber Beitelshees, Pharm.D. (University of Florida). July 2002 to June 2005. First position: Research Assistant Professor, Division of Cardiovascular Medicine, Department of Medicine, College of Medicine, Washington University (St. Louis).

Lauren Brum, Ph.D – Genetics (University of Florida). May 2003 to April 2004.

Yan Gong, Ph.D. – Pharmaceutics (University of Florida). July 2004 to June 2005. First position: Research Assistant Professor, University of Florida College of Pharmacy.

Jaekyu Shin, Pharm.D. (University of Florida). July 2004 to August 2007.

Martin Brunner, M.D. (University of Vienna). January 2005 to June 2006. First position: Assistant Professor, Department of Clinical Pharmacology, University of Vienna.

Michael Pacanowski, Pharm.D. (Philadelphia College of Pharmacy). July 2005 to present.

GRADUATE STUDENTS

Major Professor Maximilian Lobmeyer, BS. 2004 to present Anzeela Schentrup, MS, Pharm.D., 2005 to present Hrishikesh Navare, BS, MS, 2006 to present MyPhuong Le, BS, 2006 to present Elvin Price, Pharm.D. 2006 to present (co-chair) Julie A. Johnson Curriculum Vitae - Page 26

Committee Member Jennifer Dungan, RN. UF College of Nursing, February 2006 Tobias Gerhard, BS. Department of Pharmacy Healthcare Administration, February 2007 Laurie Duckworth, MSN, ARNP. College of Nursing. August 2007 Hongying Li, MS. Department of Statistics, College of Liberal Arts and Sciences, July 2007.

AWARDS AND HONORS

Ohio State University Scholarship - 1980, 1981

Rho Chi Society, Upsilon Chapter - initiated May 1984

Mortar Board National Senior Honor Society , Ohio State University chapter - initiated May 1984.

Lemmon Company Award for Outstanding Achievement in the Study of Pharmacy, 1985

The University of Texas Competitive Scholarship, 1985

The Robert G. Leonard Memorial Scholarship, University of Texas,1986

Teaching Excellence Award, 1996 - Presented by the UT Student Government Association

Elected Fellow - American College of Clinical Pharmacy, 1996

Ohio State University William Oxley Thompson Alumni Award, 1999 – awarded for distinctive career achievement to an Ohio State University alumnus less than 36 years old.

Elected Officer (Regent) – American College of Clinical Pharmacy Board of Regents, 2000-2003

FDA Committee Appointee – Nonprescription Drug Advisory Committee, 2000-2004

Phi Lambda Sigma – National Pharmacy Leadership Honor Society, inducted 2000

Outstanding Faculty of the Year, Working Professional Pharm.D. Program, University of Florida, 2001

Philip C. and Ethel R. Ashby Lecturer, University of Oklahoma College of Pharmacy, February 2003

31st Annual Albert Ebert Lecturer, University of Illinois-Chicago College of Pharmacy, April 2003

Leon I. Goldberg Young Investigator Award, American Society for Clinical Pharmacology and Therapeutics, March 2004

University of Florida Research Foundation Professorship Award, 2004-2006

V. Ravi Chandran Professor of Pharmaceutical Sciences, endowed professorship, 2004 – present

Ohio State University College of Pharmacy Distinguished Alumni Award, May 2005

David E. Guttman Memorial Lecturer, University of Kentucky College of Pharmacy, September 2006

University of Florida Faculty Achievement Recognition Award, April 2007

Paul Dawson Biotechnology Research Award, American Association of Colleges of Pharmacy, July 2007

Julie A. Johnson Curriculum Vitae - Page 27

PROFESSIONAL SERVICE

National Institutes of Health Council activities: - NIGMS National Advisory Council, ad hoc, January 2006 Study Section/Grant Review activities: - Pediatric Heart Disease Clinical Research Network, Protocol Review Committee member, January 2002 to August 2007. - Special Emphasis Panel member, February 2002, May 2002, April 2004, November 2004 - XNDA Study Section, ad hoc member, February 2006, October 2006 - XNDA Study Section member, July 2007 to June 2011 Workshops/Other activities - Workshop on Genetic Determinants of Response to Drug Therapies in Heart Failure, NHLBI, participant/speaker, September 2002 - Working Group on Polymorphisms of the -adrenergic Receptor Gene: Implications for the Pharmacotherapy of Asthma, NHLBI, participant/speaker, June 2003. - Working Group on Behavioral Genetics and Cardiovascular Disease, NHLBI, participant/speaker, August 2005 - NHLBI Advisory Group – Genotype-Guided Trial of Warfarin Therapy, NHLBI, November, 2006. NIH Pharmacogenetics Research Network (PGRN) - Coordinating Committee member, 2005 to present - Heart Lung Action Group, Chair, 2006 to present - International Warfarin Pharmacogenetics Consortium, leadership team, 2007 to present

National Science Foundation - SBIR grant review committee, May 2002

Food and Drug Administration - Nonprescription Drugs Advisory Committee member, June 2000 – May 2004.

American Heart Association Functional Genomics and Translational Biology Working Group - Steering Committee, July 2006 to June 2008 - Program Committee, Co-chair July 2006 to June 2008 Review Committee Activities: Julie A. Johnson Curriculum Vitae - Page 28

- AHA Southern/Ohio Valley Research Consortium Peer Review Committee 3A, Committee member 2004 - AHA Southern/Ohio Valley Research Consortium Peer Review Committee 3A, Committee Co- chair, 2005 - AHA Southern/Ohio Valley Research Consortium Peer Review Committee 3B, Committee Chair, 2006-2007 Research Affiliate/Consortium Service - AHA Florida/Puerto Rico Affiliate Research Committee, member 2004-2006 - AHA Research Consortium II Steering Committee member, 2007 to 2009 Other Service - UT-AHA High School Research Seminar - speaker, pharmacy representative and judge for summer research positions. 1996, 1997 - Mended Hearts - Organization of post-open heart surgery patients. Invited speaker - 1993, 1996. - Memphis Area AHA Speakers Bureau - speaker for AHA to schools, lay and civic organizations, 1997-98.

American College of Clinical Pharmacy - Research Affairs Committee member, 1989-90 - Public and Professional Relations Committee member, 1990-91 - Publications Committee member, 1991-92 - Educational Affairs Committee member, 1993, 1994 - Abstract Reviewer, 1992,1993, 1994, 1995, 1996, 1997, 1998 - 1994 Pharmacotherapy Exam Preparatory Course Planning Committee - 1993 Strategic Planning Conference, participant - ACCP Research Institute Review Panel, 1994 - Fellowship Review Committee member, 1995 to 1997 - Pharmacotherapy Self Assessment Program III - manuscript reviewer - Educational Affairs Committee chair, 1998 - 2000 Annual Meeting Program Committee chair, 1999-2000 - Pharmacotherapy Self Assessment Program IV - manuscript reviewer - Elected Officer (Regent), Board of Regents, 2000 to 2003 - Task Force on Science, secretary, 2001 - Editorial Board, Pharmacogenomics Curriculum, 2001 to present. - Credentials Committee, secretary, 2002, 2003 - Member at large representative to Pharmacotherapy Board of Directors, 2004 to present

Julie A. Johnson Curriculum Vitae - Page 29

American Association of Colleges of Pharmacy - Academic Affairs Committee, Chair, 2001-02. - Volwiler Research Achievement Award Selection Committee, 2004-05.

American Society for Clinical Pharmacology and Therapeutics - Membership Committee member, 1995 to 1998 - Scientific Program Committee member, 2004 to 2007 - Vice Chair, 2004-05 - Chair, 2005-06 - Past-chair, 2006-07 - Scientific Awards Selection Task Force, 2007 to 2008

Board of Pharmaceutical Specialties - Expert Review Panel member for 1994 Pharmacotherapy exam assembly, 1994 - Cardiology Item Writing Panel for BPS Specialty Council on Pharmacotherapy, 1995 to 1998.

American Pharmaceutical Association - Expert Reviewer for APhA Guidebook on Disease - Specific Pharmaceutical Care Protocols - Lipid Disorders, 1996 - Hypertension, 1996, 1998 - Advisory Board – APhA Special Report on Primary and Secondary Prevention of Atherosclerotic Disease, 1998

Pharmacotherapy - Quality Improvement Task Force, 1999 - Board of Directors, 2004-present

Scientific Editor - Pharmacotherapy, 2006 to present

Editorial Boards: - Clinical Pharmacology and Therapeutics, 2005 to present - Pharmacotherapy, 1993-present - Pharmacogenomics: Applications to Patient Care; 2001 to present - Pharmacogenetics and Genomics, 2002-present - Personalized Medicine, 2004-present

Julie A. Johnson Curriculum Vitae - Page 30

Manuscript reviewer (since 1995): - American Journal of Pharmacogenomics - American Pharmaceutical Association Special Publications - Biopharmaceutics and Drug Disposition - BMC Medical Genetics - British Journal of Clinical Pharmacology - Clinical Pharmacology and Therapeutics - Current Pharmacogenomics - Current Opinions in Molecular Therapeutics - DICP - The Annals of Pharmacotherapy - European Heart Journal - Genomics - Heart Journal - Human Genetics - Human Genomics - JAMA – Journal of the American Medical Association - Journal of Pharmacology and Experimental Therapeutics - Journal of Pharmacy and Pharmacology - Journal of Pharmaceutical Sciences - Nature Genetics - Nature Cardiovascular Medicine - New England Journal of Medicine - Pharmacogenetics and Genomics - Pharmacogenomics Journal - Pharmacological Reviews - Pharmacotherapy - Pharmacotherapy Self Assessment Program IV - Psychosomatic Medicine - Vascular Medicine

UNIVERSITY SERVICE

UNIVERSITY OF TENNESSEE - Faculty Senate, College of Pharmacy At Large Representative, 1991 - 1994. Member, Communications Committee, 1993-94 Member, Faculty Affairs Committee, 1994-95 - Mentor, Office of Career Programs. Program for minority high school students, 1993. - Campus Research Committee member, 1994 -1995. Member, Research Development Subcommittee, 1994-95. - General Clinical Research Center Scientific Advisory Committee member, 1994-1998. - Mentor - Cardiovascular-Renal Summer Minority Research Program. 1995, 1996, 1997

University of Tennessee College of Pharmacy - Department of Clinical Pharmacy Chairman Search Advisory Committee, 1990-91. - Academic Standards and Promotion Review Committee, 1990-1994. - Van Vleet Professor of Pharmacy (Endowed Chair) Search Advisory Committee, 1991-92. - Chair, Sub-committee to review Drug Information Course, 1993 - Coordinator, Molecular Biology Journal Club, 1994 to 1997 - Curriculum committee, 1995-96 Chair, Subcommittee for development of external Pharm.D. degree, 1996 Chair, Subcommittee to review Pharmacology course, 1996. - Promotion and Tenure Committee, appointed representative, 1996 to 1998. Julie A. Johnson Curriculum Vitae - Page 31

University of Tennessee Department of Clinical Pharmacy - Postdoctoral training committee, 1990-91. - Coordinator, Pharmacotherapy Exam study group, 1992. - Coordinator, Departmental Pharmacokinetics/dynamics Journal Club, 1991 to 1997. - Research committee, 1993 to 1996. - Coordinator - Department of Clinical Pharmacy Research Seminar, 1993 to 1998.

UNIVERSITY OF FLORIDA University of Florida

- Institute on Aging Advisory Board, 2000 to 2001 - Institute on Aging Faculty Search Committee, 2000 - Center for Pharmacogenomics, Director, 2001-present - University of Florida Genetics Institute, Executive Committee member, 2003 – present - University of Florida NIH K-30 funded Advanced Postgraduate Program in Clinical Investigation Advisory Committee – 2003 – present - University of Florida Institute for Biotechnology Research Director Search Committee, 2005- 2006. - Center for Translational Science Award Steering Committee (Pharmacy Representative) – 2006 to present

College of Pharmacy

- Academic Performance Committee, 1999 to 2002 - Curriculum Committee, 1999 to 2001 - Tenure and Promotion Committee, 2001 to 2003 - Executive Committee, 2002 to present

Department of Pharmacy Practice

- Faculty Search Committee, 1998-99. - Chair, Department of Pharmacy Practice, 2002 to present

Department of Pharmaceutics

- Faculty Search Committee, 2002

TEACHING

AWARDS:

Teaching Excellence Award, 1996 - Presented by the University of Tennessee Student Government Association

Outstanding Faculty Award, University of Florida Working Professional Pharm.D. Program, 2001

UNIVERSITY OF TENNESSEE

CLPH 311 and 312 - Therapeutics I and II Julie A. Johnson Curriculum Vitae - Page 32

1989-1998: Team taught therapeutics course for third year Pharm.D. students with class sizes of 70 to 100 students. Delivered approximately 20 lecture hours per year on cardiovascular therapeutics as well as leading 4 to 5 recitation sessions per year. Presented lectures on most topics in cardiovascular therapeutics. Course coordinator: 1991, 1992.

CLPH 410: Cardiology Clerkship

1990-1998: Preceptor for a cardiology clerkship based in the Coronary Care Unit/Cardiology Service at the Veterans Administration Medical Center at Memphis. Site co-precepted by Dr. Robert B. Parker; combined we had approximately 18 to 22 fourth year students per year.

CLPH 315 Applied Clinical Pharmacokinetics:

1991-1996: Course lecturer (3-6 hours per year) plus recitation leader. Class size of 70-100 students. Lecture topics included: clearance concepts, hepatic clearance, hepatic drug interactions, hepatic drug metabolism, P-glycoprotein’s impact on kinetics and clinical pharmacokinetics of: lidocaine, procainamide, digoxin, other antiarrhythmics

1997: Course coordinator.

Other:

Also participated in Women’s Health Selective Course, Applied Therapeutics, and Critical Care Selective Course for pharmacy students and Clinical Pharmacology and Therapeutics Course for 4th year medical students.

UNIVERSITY OF FLORIDA

PHA5683; Ambulatory Care Clerkship

1999 to 2002: Co-precepted with 3 other faculty members. Precepted students in heart failure/heart transplantation clinic

Research Elective Clerkship – course number varies by month

2002 to present. Precept students in an elective research rotation that provides them with exposure to clinical research, informed consent, clinical trial design and statistic issues, pharmacogenomics, genetics and genomics nomenclature, laboratory aspects of pharmacogenomics research.

PHA 5781; Pharmacotherapy I

2001: Coursemaster and lecturer. Class size of approximately 130 students. Course covering introductory pharmacotherapy topics.

PHA 5782; Pharmacotherapy II

1998: Course co-coordinator and small group leader. Class size of approximately 130 students. Course covers the pharmacotherapy of cardiovascular, pulmonary, gastrointestinal, psychiatric and renal diseases and transplantation. Lectures given in cardiovascular pharmacotherapy.

1999: Coursemaster, lecturer and small group leader, class size of 130 students

2000-present: Lecturer on cardiovascular pharmacotherapy topics; class size – 2000-2002: 130 students; since 2003: 270 to 300 students. Julie A. Johnson Curriculum Vitae - Page 33

PHA5784 Pharmacotherapy IV

2000-present: Pharmacokinetics case faculty leader. Course is a case-based course where students are provided a case assignment and then must answer in class the questions posed to them by a faculty member; class size – 130 students.

PHA5887; Pharmacotherapy V

2000-present: Pharmacokinetics case faculty leader. Course is a case-based course where students are provided a case assignment and then must answer in class the questions posed to them by a faculty member; class size – 130 students.

PHA 5128; Basic Principles of Dose Optimization II

1999-2004: Course lecturer on drug metabolism/drug-drug interactions, pharmacogenetics. Class size of approximately 130 students.

PHA 5516; Pharmacologic Basis of Therapeutics

1999-2001: Course lecturer on antihyperlipidemic agents pharmacology. Class size of approximately 130 students.

GMS6181; Science of Clinical Research

2000-present. Lecturer. Survey course on clinical research for post-doctoral fellows, and graduate students enrolled in the K30 Clinical Sciences program. Class size: approximately 60 students.

PHA 5941; Practicum I

1998: Small group facilitator. Class size of approximately 20 students.

CURRICULUM VITAE

Leslie Hendeles, Pharm.D. September 2007

BIOGRAPHICAL

Birth Date: May 30, 1943 Birth Place: Alhambra, CA

Home Address: 3549 N.W. 30th Blvd. Home Phone/Fax: 352- 377-0954 Gainesville, FL 32605

Business Address: University of Florida Business Phone: 352-273-6027 Health Science Center (Box 100486) 1600 SW Archer Road, Room PG-05 Business Fax: 352-273-6120 Gainesville, FL 32610-0486

Email Address: [email protected] Cell Phone: 352-494-7932

EDUCATION Pre-Pharmacy, Los Angeles City College, Los Angeles, CA, 1961-1963

Undergraduate Psychology, San Francisco State College, San Francisco, CA, 1964-1965

Pharm.D., University of Southern California, Los Angeles, CA , June 1969

LICENSES/CERTIFICATES Registered Pharmacist, Florida, 1981-present National Provider Identifier # 1205944584

Asthma Disease State Management Examination, National Association of Boards of Pharmacy, passed 1999

Spirometry Certificate, National Institute for Occupational Safety and Health, 2000

Asthma Educator, National Asthma Educator Certification Board, 2003

AWARDS AND HONORS American Society of Hospital Pharmacists Research and Education Foundation Award for an Outstanding Contribution to the Literature of Research in Hospital Pharmacy, 1981

American College of Clinical Pharmacy, Russell R. Miller Award for sustained and outstanding contribution to the literature of clinical pharmacy, 1987

University of Southern California, School of Pharmacy's Outstanding Alumnus, 1993

Q:Home/Rice/CV’s\LH-CV.doc Curriculum Vitae Leslie Hendeles Page 2

American College of Clinical Pharmacy, Therapeutic Frontiers Lecture Award, 1996

American Pharmaceutical Association, Research Achievement Award in Pharmaceutical Sciences, March 2002

University of Florida Working Professional Pharm.D. Program, Outstanding Faculty of the Year, August 2002

University of Florida Research Foundation Professorship Award for 2003- 2006, March 2003

Pediatric Pharmacy Advocacy Group, Sumner J. Yaffe Lifetime Achievement Award for 2007

NATIONAL COMMITTEES AND APPOINTMENTS United States Pharmacopeial Convention, Inc., Pulmonary Disease Advisory Committee, 1981-1985

American Academy of Allergy, Task Force on Guidelines for Clinical Investigation of Non-Bronchodilator Antiasthmatic Drugs, 1985

National Asthma Mortality Task Force, 1986

Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee, 1986-1992

American Pharmaceutical Association, Task Force on Bioequivalency Guidelines, 1989

Food and Drug Administration, Center for Drug Evaluation and Research, Special Government Consultant, 1991-present

NHLBI's National Asthma Education and Prevention Program, Coordinating Committee, representing the American Society of Hospital Pharmacists, 1992-2005

NHLBI Special Review Committee for RFA for Asthma Clinical Research Network, February 2003

CDC, Expert Panel on Guidelines for Asthma Treatment by Emergency Medical Services (EMS), April 2004.

PROFESSIONAL AND SCIENTIFIC MEMBERSHIPS American Society of Health-System Pharmacists, 1968-present

Curriculum Vitae Leslie Hendeles Page 3

American Academy of Allergy & Immunology, 1976-present

American College of Clinical Pharmacy, 1979-present Founding Member, 1979 Fellow, 1985 Research Affairs Committee, 1985 Chairperson, Scientific Session, 1985 Annual Meeting Chairperson, Awards Committee, 1987-1988

American Pharmaceutical Association, 1980-present

American Thoracic Society, 1980-present

Florida Pharmacy Association, 1981-2004

PROFESSIONAL EXPERIENCE Cedars of Lebanon Hospital, Los Angeles Intern Pharmacist, 1967-1969

Memorial Hospital Medical Center of Long Beach, CA Clinical Pharmacist, 1969-1971

University of Georgia, School of Pharmacy Assistant Professor of Clinical Pharmacy, 1971-1972

The University of Iowa Assistant Professor, College of Pharmacy, 1972-1978 Clinical Pharmacist, Pediatric Allergy Clinic, 1975-1980 Associate Professor with tenure, College of Pharmacy, 1978-1980

The University of Florida Associate Professor of Pharmacy and Pediatrics, 1980-1984 Clinical Pharmacist, Pediatric Clinical Pharmacology/Toxicology Division, 1980-1988 Professor of Pharmacy and Pediatrics with tenure, 1984-present Clinical Pharmacist, Pediatric Pulmonary Division, 1988-present

U.S. Food and Drug Administration Visiting Scientist, Division of Pulmonary/Allergy Drugs, 8/93-5/94

EDITORIAL ACTIVITIES Editorial Advisor Board, Drug Intelligence and Clinical Pharmacy, 1975- 1980

Reviewer, American Journal of Hospital Pharmacy, 1975-1998

Reviewer, Journal of Allergy and Clinical Immunology, 1979-present

Reviewer, The Medical Letter, 1981-present

Curriculum Vitae Leslie Hendeles Page 4

Editorial Board, Pharmacotherapy, 1981-2006

Reviewer, Journal of Pediatrics, 1981-present

Reviewer, Chest, 1981-present

Reviewer, American Journal of Respiratory and Critical Care Medicine, 1984-present

Editorial Board, Journal of Pediatric Pharmacology and Therapeutics, 2000-present

Reviewer, New England Journal of Medicine, 2002-present

Reviewer, Journal of the American Medical Association, 2002-present

Member, Prescriber’s Letter/Pharmacist’s Letter Specialty Consultant Panel, 2005

OTHER ACTIVITIES Emergency Medical Services Advisory Council, Alachua County, FL 12/95-present

Board of Directors, Alachua County Organization for Rural Need, Inc. (ACORN), 2002-present

PATENTS Golub A, Hendeles L. Method and Composition for Treating Bronchospastic Airway Disease. U.S. Patent Number 4,689,213. August 25, 1987.

Innovata Biomed Ltd/University of Florida International Patent Application No PCT/GB01/02648

Methacholine Disposable Inhaler, 2001

JOURNAL ARTICLES (REFEREED)

1. Hendeles L. A guide to gentamicin therapy. Drug Intell Clin Pharm 1971;5:393-96.

2. Hendeles L. Uncomplicated gonococcal infections. Drug Intell Clin Pharm 1973;7:205-7.

3. Hanson D, Hendeles L. Guide to total dose intravenous iron dextran therapy. Am J Hosp Pharm 1974;31:592-5.

4. Hendeles L. A need for counter-detailing antibiotics. Am J Hosp Pharm 1976;33:918-24.

5. Weinberger M, Hendeles L. Pharmacotherapy of asthma. Am J Hosp Pharm 1976;33:1071-80.

6. Hendeles L, Bighley L, Richardson RH, Hepler CD, Carmichael J. Frequent toxicity from IV aminophylline infusions in critically ill patients. Drug Intell Clin Pharm 1977;11:12-18. (published Curriculum Vitae Leslie Hendeles Page 5

again as a historical view -– Ann Pharmacother 2006;40:1417-23).

7. Weinberger M, Hendeles L. Management of asthma. Postgrad Med 1977;61:85-103.

*8. Hendeles L, Weinberger M, Bighley L. Absolute bioavailability of oral theophylline. Am J Hosp Pharm 1977;34:525-7.

9. Matheson LE, Bighley L, Hendeles L. Drug interference with the Schack and Waxler plasma theophylline assay. Am J Hosp Pharm 1977;34:496-9.

10. Alexander MR, Hendeles L, Guernsey B. The beta-2 agonist bronchodilators. Drug Intell Clin Pharm 1977;11:526-32.

11. Hendeles L, Burkey S, Bighley L, Richardson R. Unpredictability of theophylline saliva measurements in chronic obstructive pulmonary disease. J Allergy Clin Immunol 1977;60:335-8.

12. Hendeles L, Kagan BM. The prevention of meningococcal disease in the community. Drug Intell Clin Pharm 1978;12:278-3.

13. Wyatt R, Weinberger M, Hendeles L. Oral theophylline dosage for the management of chronic asthma. J Pediatr 1978;92:125-30.

14. Sintek C, Hendeles L, Weinberger M. Activated charcoal adsorption of theophylline in-vitro. Drug Intell Clin Pharm 1978;12:158-9.

15. Ekwo E, Hendeles L, Weinberger M. Those who make decisions about management of children with asthma: pharmacist-physician interaction. Am J Hosp Pharm 1978;35:295-9.

16. Hendeles L, Weinberger M, Bighley L. Disposition of theophylline after a single intravenous infusion of aminophylline. Am Rev Resp Dis 1978;118:97-103.

17. Hendeles L, Weinberger M, Johnson G. Monitoring serum theophylline levels. Clin Pharmacokinet 1978;3:294-312.

18. Hendeles L, Weinberger M, Wyatt A. Guide to oral theophylline therapy for the treatment of chronic asthma. Am J Dis Child 1978;132:876-80.

19. Weinberger M, Hendeles L, Bighley L. The relation of product formulation to absorption of oral theophylline. N Engl J Med 1978;299:852-7.

20. Sintek C, Hendeles L, Weinberger M. Inhibition of theophylline absorption by activated charcoal. J Pediatr 1979;94:314-6.

21. Schaaf L, Hendeles L, Weinberger M. Suppression of seasonal allergic rhinitis symptoms with daily hydroxyzine. J Allergy Clin Immunol 1979;63:129-33.

22. Walker J, Hendeles L. The interaction of erythromycin and theophylline in the asthmatic dental patient. JADA 1979;99:995-6.

Curriculum Vitae Leslie Hendeles Page 6

23. Hendeles L, Weinberger M, Wong L. Medical management of non-infectious rhinitis. Am J Hosp Pharm 1980;37:1496-504.

* The most frequently cited article from AJHP for the years 1955-1986 (Am J Hosp Pharm 1989;46:126-28).

24. Weinberger M, Hendeles L. Experience with theophylline for the management of chronic asthma. Eur J Respir Dis 1980(suppl 109);61:120-33.

25. Hendeles L, Weinberger M. Avoidance of adverse effects during chronic therapy with theophylline. Eur J Resp Dis 1980(suppl 109);61:103-19.

26. Sarrazin E, Hendeles L, Weinberger M, Muir K, and Riegelman S. Dose-dependent kinetics for theophylline: Observations among ambulatory asthmatic children. J Pediatr 1980;97:825-8.

27. Bonham A, Hendeles L, Vaughan L, Weinberger M. The reliability of serum theophylline determinations from clinical laboratories. Am Rev Resp Dis 1980;122:829-32.

28. Nassif EG, Weinberger MM, Shannon D, Guiang SF, Hendeles L, Jimenez D, Ekwo E. Theophylline disposition in infancy. J Pediatr 1981;98:158-61.

29. Hendeles L, Vaughan L, Weinberger M, Smith G. Influence of gender on theophylline dosage requirements in children with chronic asthma. Drug Intell Clin Pharm 1981;15:338-40.

30. Wong L, Hendeles L, Weinberger M. Pharmacologic prophylaxis of allergic rhinitis: relative efficacy of hydroxyzine and chlorpheniramine. J Allergy Clin Immunol 1981;67:223-8.

31. Weinberger M, Hendeles L, Wong L, Vaughan L. Relationship of formulation and dosing interval to fluctuation of serum theophylline concentration in children with chronic asthma. J Pediatr 1981;99:145-52.

32. Prince RA, Wing DS, Weinberger M, Hendeles LS, Riegelman S. Effect of erythromycin on theophylline kinetics. J Allergy Clin Immunol 1981;68:427-31.

33. Hendeles L, Weinberger M. Improved efficacy and safety of theophylline for control of airways hyperreactivity. Ann Allergy 1982;49:247-56.

34. Iafrate RP, Hendeles L, Karnes HT. Measurement of low tobramycin concentrations by the EMIT assay. Am J Hosp Pharm 1982;39:1965-6.

35. Whelan HT, Hendeles L, Haberkern CM, Neims AH. High intravenous phenytoin dosage requirement in a newborn infant. Neurology 1983;33:106-8.

36. Hittel WP, Iafrate RP, Karnes HT, Hendeles L. Stability of pentobarbital sodium in 5% dextrose injection and 0.9% sodium chloride injection. Am J Hosp Pharm 1983;40:294-6.

37. Hendeles L, Weinberger M. Theophylline: "A state of the art" review. Pharmacotherapy 1983;3:2- 44.

38. Weinberger M, Hendeles L. Slow-release theophylline rationale and basis for product selection. N Curriculum Vitae Leslie Hendeles Page 7

Engl J Med 1983;308:760-4.

39. Quattrocchi F, Karnes HT, Robinson JD, Hendeles L. Effect of serum separator blood collection tubes on drug concentrations. Ther Drug Monit 1983;5:359-62.

40. Hendeles L, Iafrate RP, Weinberger M. A clinical and pharmacokinetic basis for the selection and use of slow release theophylline products. Clin Pharmacokinet 1984;9:95-135.

41. Hendeles L, Weinberger M. Non-prescription sale of inhaled metaproterenol: déjà vu. N Engl J Med 1984;310:207-8.

42. Spehar AM, Hill MR, Mayhew IG, Hendeles L. Preliminary study on the pharmacokinetics of phenobarbital in the neonatal foal. Equine Vet J 1984;16:368-71.

43. Karnes HT, Iafrate RP, Gudat JC, Hendeles L. Evaluation of a rapid immunoassay for monitoring serum pentobarbital concentrations. Am J Hosp Pharm 1984;41:2642-6.

44. Hendeles L, Hill M, Iafrate RP. Measurement of tobramycin concentrations in saliva. Drug Intell Clin Pharm 1985;19:378-80.

45. Hendeles L, Weinberger M, Milavetz G, Hill M, Vaughan L. Food-induced “dose-dumping” from a once-a-day theophylline product as a cause of theophylline toxicity. Chest 1985;87:758-65.

46. Hendeles L, Weinberger M. Theophylline product and dosing interval selection for chronic asthma. J Allergy Clin Immunol 1985;76(suppl):285-91.

47. Weinberger M, Hendeles L. Theophylline use: an overview. J Allergy Clin Immunol 1985;76(suppl):277-84.

48. Hendeles L, Massanari M, Weinberger M. Update on the pharmacodynamics and pharmaco- kinetics of theophylline. Chest 1985;88(suppl):103S-11S.

49. Iafrate RP, Massey KL, Hendeles L. Current concepts in clinical therapeutics: asthma. Clin Pharm 1986;5:206-27.

50. Milavetz G, Vaughan LM, Weinberger MM, Hendeles L. Evaluation of a scheme for establishing and maintaining dosage of theophylline in ambulatory patients with chronic asthma. J Pediatr 1986;109:351-4.

51. Massey KL, Hendeles L, Neims A. Identification of children for whom routine monitoring of aminoglycoside serum concentrations is not cost effective. J Pediatr 1986;109:897-901.

52. Hill MR, Gotz VP, Harman E, McLeod I, Hendeles L. Evaluation of the asthmogenicity of propafenone, a new antiarrhythmic drug; comparison of spirometry with methacholine challenge. Chest 1986;90:698-702.

53. Hendeles L, Weinberger M. Selection of a slow-release theophylline product. J Allergy Clin Immunol 1986;78:743-51.

Curriculum Vitae Leslie Hendeles Page 8

54. Weinberger M, Hendeles L. Therapeutic effect and dosing strategies for theophylline in the treatment of chronic asthma. J Allergy Clin Immunol 1986;78:762-8.

55. Hendeles L, Iafrate RP, Stillwell PC, Mangos JA. Individualizing gentamicin dosage in patients with cystic fibrosis: limitations to the pharmacokinetic approach. J Pediatr 1987;110:303-10.

56. Massey KL, Hendeles L. Calcium antagonists in the management of asthma: breakthrough or ballyhoo? Drug Intell Clin Pharm 1987;21:505-9.

57. Harman E, Hill M, Fiebelman R, Pieper J, Hendeles L. The effect of oral diltiazem on airway reactivity to methacholine and exercise in subjects with mild intermittent asthma. Am Rev Resp Dis 1987;136:1179-82.

58. Sallent J, Hill M, Stecenko A, McKenzie M, Hendeles L. Bioavailability of a slow-release theophylline capsule given twice daily to preschool children with chronic asthma: comparison with liquid theophylline. Pediatrics 1988;81:116-20.

59. Hendeles L, Hill M, Harman E, Moore P, Pieper J. Dose-response of inhaled diltiazem on airway reactivity to methacholine and exercise in subjects with mild asthma. Clin Pharmacol Ther 1988;43:387-92.

60. Blake KV, Bailey D, Zientek GM, Hendeles L. Death of a child associated with multiple overdoses of acetaminophen. Clin Pharm 1988;7:391-7.

61. Massey KL, Hill M, Harman E, Rutledge DR, Ahrens R, Hendeles L. Dose response of inhaled gallopamil (D600), a calcium channel blocker, in attenuating airway reactivity to methacholine and exercise. J Allergy Clin Immunol 1988;81:912-8.

62. Hendeles L, Edwards C. Clinical assessment of an enzyme immunoassay (EMIT) for measurement of serum salicylate. J Clin Pharm Ther 1988;13:131-8.

63. Hill M, Hendeles L. Evaluation of an office method of measuring theophylline serum concentrations. J Allergy Clin Immunol 1988;82:30-4.

64. Massey KL, Harman E, Hendeles L. Duration of protection of calcium channel blockers against exercise-induced bronchospasm: comparison of oral diltiazem and inhaled gallopamil. Eur J Clin Pharmacol 1988;34:555-9.

65. Massey KL, Harman E, Hendeles L. Duration of effect of gallopamil, a calcium channel blocker, on methacholine-induced bronchoconstriction. Pharmacotherapy 1988;8:189-92.

66. Mac Millan M, Petty W, Hendeles L. Effect of irrigation and tourniquet application on aminoglycos- ide antibiotic concentrations in bone. J Orthop Res 1988;6:311-6.

67. Christopher MA, Wyzan D, Harman E, Hendeles L. The effects of nalmefene, a potent oral opiate antagonist, on exercise-induced bronchospasm. J Allergy Clin Immunol 1988;82:1037-41.

68. Blake KV, Massey KL, Hendeles L, Nickerson D, Neims A. Relative efficacy of phenytoin and Curriculum Vitae Leslie Hendeles Page 9

phenobarbital for the prevention of theophylline-induced seizures in mice. Ann Emerg Med 1988;17:1024-28.

69. Christopher MA, Harman E, Hendeles L. Clinical relevance of the interaction of theophylline with diltiazem or nifedipine. Chest 1989;95:309-13.

70. Milov DE, Hill M, Andres JM, Cynamon HA, Hendeles L. Measurement of plasma prednisolone level to evaluate a prednisone treatment failure in an adolescent with Crohn's disease. J Pediatr Gastroenterol Nutr 1989;8:404-07.

71. Hendeles L, Dorf A, Stecenko A, Weinberger M. Treatment failure after substitution of generic pancrelipase capsules; correlation with in vitro lipase activity. JAMA 1990;263:2459-61.

72. Harman E, Hill M, Pieper JA, Hendeles L. Inhaled verapamil-induced bronchoconstriction in mild asthma. Chest 1991;100:17-22.

73. Blake KV, Harman E, Hendeles L. Evaluation of a generic albuterol metered-dose inhaler: importance of priming the MDI. Ann Allergy 1992;68:169-74.

74. Blake KV, Hoppe M, Harman E, Hendeles L. Relative amount of albuterol delivered to lung receptors from a metered-dose inhaler and nebulizer solution; bioassay by histamine bronchoprovocation. Chest 1992;101:309-15.

75. Hendeles L, Weinberger M, Szefler S, Ellis E. Safety and efficacy of theophylline in children with asthma. J Pediatr 1992;120:177-83.

76. Hoppe M, Harman E, Hendeles L. The effect of inhaled gallopamil, a potent calcium channel blocker, on the late-phase response in subjects with allergic asthma. J Allergy Clin Immunol 1992;89:688-95.

77. Idris AH, McDermott MF, Raucci JC, Morrabel A, McGorray S, Hendeles L. Emergency department treatment of severe asthma: metered-dose inhaler plus holding chamber is equivalent in effectiveness to nebulizer. Chest 1993;103:665-72.

78. Hendeles L, Hochhaus G, Kazerounian S. Generic and alternative brand-name pharmaceutical equivalents: Select with caution. Am J Hosp Pharm 1993;50:323-9.

79. Carter E, Cruz M, Chesrown S, Shieh G, Reilly K, Hendeles L. Efficacy of intravenously administered theophylline in children hospitalized with severe asthma. J Pediatr 1993;122:470-6.

80. Hendeles L. Efficacy and safety of antihistamines and expectorants in non prescription cough and cold preparations. Pharmacotherapy 1993;13:154-8.

81. Huang D, O'Brien R, Harman E, Aull L, Reents S, Visser J, Shieh G, Hendeles L. Does aminophyl- line benefit adults admitted to the hospital for an acute exacerbation of asthma? Ann Intern Med 1993;119:1155-60.

82. Hochhaus G, Hendeles L, Harman E, Moellmann H. PK/PD analysis of albuterol action: application Curriculum Vitae Leslie Hendeles Page 10

to a comparative assessment of Beta-adrenergic drugs. Eur J Pharm Sci 1993;1:73-80.

83. Hendeles L. Selecting a decongestant. Pharmacotherapy 1993;13:129S-34S.

84. Kraisinger M, Hochhaus G, Stecenko A, Bowser E, Hendeles L. Clinical pharmacology of pancreatic enzymes in patients with cystic fibrosis and in vitro performance of microencapsulated formulations. J Clin Pharmacol 1994;34:158-66.

85. Kanthawatana S, Ahrens RC, McCubbin M, Bronsky E, Blake K, Hendeles L. Bioequivalence of a generic slow-release theophylline tablet in children. J Pediatr 1994;125:987-91.

86. Hendeles L, Harman E, Huang D, O'Brien R, Blake K, Delafuente J. Theophylline attenuation of airway responses to allergen; comparison with cromolyn MDI. J Allergy Clin Immunol 1995;95:505- 14.

87. Hendeles L, Breton AL, Beaty R, Harman E. Therapeutic equivalence of a generic slow-release theophylline tablet. Pharmacotherapy 1995;15:26-35.

88. Hendeles L, Jenkins J, Temple R. Revised FDA labeling guideline for theophylline oral dosage forms. Pharmacotherapy 1995;15:409-27.

89. National Asthma Education and Prevention Program. Role of the pharmacist in improving asthma care. Am J Health-Syst Pharm 1995;52:1411-16.

90. Weinberger M, Hendeles L. Theophylline in asthma. N Engl J Med 1996;334:1380-88.

91. Hendeles L, Harman E. Use of allergen bronchoprovocation to screen drugs for anti-asthma activity. Pharmacotherapy 1997;17:39S-49S.

92. Brueckner JW , Marshik P, Sherman J, Hendeles L. Reliability of the Medtrac MDI Chronolog; J Allergy Clin Immunol 1997;100:488-91.

93. Reiss TF, Hill JB, Harman E, Zhang J, Tanaka WK, Bronsky E, Guerreiro D, Hendeles L. Increased urinary excretion of LTE4 after exercise and attenuation of exercise-induced bronchospasm by montelukast, a cysteinyl leukotriene receptor antagonist. Thorax 1997;52:1030-5.

94. Asmus MJ, Weinberger M W, Milavetz G, Marshik P, Teresi M E, Hendeles L. Apparent decrease in population clearance of theophylline: implications for dosage. Clin Pharmacol Ther 1997;62:483- 89.

95. Foster M, Kottler WF, Hendeles L. Relative antihistaminic potency of doxepin and hydroxyzine. J Clin Derm 1998;1:7-10.

96. Beasley R, Fishwick D, Miles J, Hendeles L. Preservatives in nebulizer solutions: risks without benefit. Pharmacotherapy 1998;18:130-139.

97. Leff JA, Busse WW, Pearlman D, Bronsky ED, Kemp J, Hendeles L, Dockhorn R, Kundu S, Zhang J, Seidenberg BC, Reiss TF. Montelukast, a leukotriene-receptor antagonist, for the treatment of mild asthma and exercise-induced bronchoconstriction. N Engl J Med 1998;339:147-52. Curriculum Vitae Leslie Hendeles Page 11

98. Marshik P, Moghaddam S, Tebbett I, Hendeles L. Degradation of histamine solutions used for bronchoprovocation. Chest 1999;115:194-9.

99. Pizzichini E, Leff JA, Reiss TF, Hendeles L, Boulet L-P, Wei LX, Efthimiadis A, Zhang J, Hargreave FE. Montelukast reduces airway eosinophilic inflammation in asthma: a randomized controlled trial. Eur Respir J 1999;14:12-8.

100. Sherman JM, Hendeles L. Improving adherence to asthma medications. Contemp Pediatr 1999;16:51-64.

101. Ahrens RC, Hendeles L, Clarke WR, Dockhorn RJ, Hill MR, Vaughan LM, Lux C, Han S-H. Therapeutic equivalence of Spiros dry powder inhaler and Ventolin metered dose inhaler: a bioassay using methacholine. Am J Resp Crit Care Med 1999;160:1238-43.

102. Asmus MJ, Sherman J, Hendeles L. Bronchoconstrictor additives in bronchodilator solutions. J Allergy Clin Immunol 1999;104:S53-60.

103. Hendeles L, Davison D, Harman E, Sherman JM. The effect of cys LT1 receptor blockade on airway responses to allergen. Pharmacotherapy 1999;19:1243-51.

104. Asmus M, Hendeles L. Levalbuterol nebulizer solution: is it worth five times the cost of albuterol? Pharmacotherapy 2000;20:123-9.

105. Sherman J, Hutson A, Baumstein S, Hendeles L. Telephoning the patient’s pharmacy to assess adherence with asthma medications by measuring refill rate for prescriptions. J Pediatr 2000;136:532-6.

106. Asmus MJ, Barros MD, Liang J, Chesrown SE, Hendeles L. Pulmonary function response to EDTA, an additive in nebulized bronchodilators. J Allergy Clin Immunol 2001;107:68-72.

107. Sherman JM, Baumstein S, Hendeles L. Intervention strategies for children poorly adherent with asthma medications; one center’s experience. Clin Pediatr 2001;40:253-8.

108. Hendeles L, Asmus M, Chesrown S. What is the role of budesonide inhalation suspension for nebulization? J Pediatr Pharmacol Ther 2001;6:162-6.

109. Bessmertny O, Liang J, Hochhaus G, Chesrown S, Hendeles L. Fluticasone plasma concentrations in children with asthma after delivery by MDI. J Pediatr Pharmacol Ther 2001;6:212-7.

110. Sherman J, Patel P, Hutson A, Chesrown S, Hendeles L. Adherence to oral montelukast and inhaled fluticasone in children with persistent asthma. Pharmacotherapy 2001;21:1464-7.

111. Faro A, DeNicola L, Beierle E, Langham MR, Kissoon N, Pham N, Hendeles L, Kays D, Chen M. Extracorporeal membrane oxygenation rescue therapy in a child with status asthmaticus: limits of conventional therapy. J Pediatr Pharmacol Ther 2001;6:504-8.

112. Julius SM, Sherman JM, Hendeles L. Accuracy of three electronic monitors for meter dose inhalers. Chest 2002;121:871-6. Curriculum Vitae Leslie Hendeles Page 12

113. Twiss MA, Harman E, Chesrown S, Hendeles L. Efficacy of calcium channel blockers as maintenance therapy for asthma. Br J Clin Pharmacol 2002;53:243-9.

114. Lilly CM, Churg A, Lazarovich M, Pauwels R, Hendeles L, Rosenwasser LJ, Ledford D, Wechsler ME. Asthma therapies and Churg-Strauss Syndrome. J Allergy Clin Immunol 2002;109:S1-20.

115. Asmus MJ, Vaughan LM, Hill MR, Chesrown SE, Hendeles L. Stability of frozen methacholine solutions in unit-dose syringes for bronchoprovocation. Chest 2002;121:1634-7.

116. Liang J, Asmus MJ, Hochhaus G, Chesrown S, Hendeles L. Differences in inhaled fluticasone bioavailability between holding chambers in children with asthma. Pharmacotherapy 2002;22:947- 53.

117. Hendeles L, Sherman J. Are inhaled corticosteroids effective for acute exacerbations of asthma in children? J Pediatr 2003;142(2 Suppl):26S-33S.

118. Hendeles L. Selecting a systemic corticosteroid for acute asthma in young children. J Pediatr 2003;142(2 Suppl):40S-44S.

119. Hendeles L, Asmus MJ, Chesrown S. Management of exercise-induced bronchospasm. J Pediatr Pharmacol Ther 2003;8:13-21.

120. Hendeles L, Asmus M, Chesrown S. Evaluation of cytokine modulators for asthma. Paediatr Respir Rev 2003;4(Suppl 1):S105-S110.

121. Wubbel C, Asmus MJ, Stevens G, Chesrown SE, Hendeles L. Methacholine challenge testing - comparison of the two American Thoracic Society-recommended methods. Chest 2004;125:453-8.

122. Hendeles L, Beaty R, Ahrens R, Stevens G, Harman EM. Response to inhaled albuterol during nocturnal asthma. J Allergy Clin Immunol 2004;113:1058-62.

123. Hendeles L, Hatton RC, Coons TJ, Carlson L. Automatic replacement of albuterol nebulizer therapy by metered-dose inhaler and valved holding chamber. Am J Health-Syst Pharm 2005;62:1053-61.

124. Hendeles L, Marshik PL, Ahrens R, Kifle Y, Shuster J. Response to nonprescription epinephrine inhaler during nocturnal asthma. Ann Allergy Asthma Immunol 2005;95:530-4.

125. Khan YR, McDonough P, Cockcroft DW, Davis BE, Hendeles L. Nebulizer output for methacholine challenges with the KoKo Digidoser. J Allergy Clin Immunol 2005;116:924-6.

126. Borowitz D, Goss CH, Stevens C, Hayes D, Newman L, O’Rourke A, Konstan MW, Wagener J, Moss R, Hendeles L, Orenstein D, Ahrens R, Oermann CM, Aitken ML, Mahl TC, Young KR, Dunitz J, Murray FT. Safety and preliminary clinical activity of a novel pancreatic enzyme preparation in pancreatic insufficient cystic fibrosis patients. Pancreas 2006;32:258-63.

127. Pearlman DS, van Adelsberg J, Philip G, Tilles SA, Busse W, Hendeles L, Loeys T, Dass SB, Curriculum Vitae Leslie Hendeles Page 13

Reiss TF. Onset and duration of protection against exercise-induced bronchoconstriction by a single oral dose of montelukast. Ann Allergy Asthma Immunol 2006;97:98-104.

128. Khan Y, Tang Y, Hochhaus G, Shuster JJ, Spencer T, Chesrown S, Hendeles L. Lung bioavailability of hydrofluoroalkane fluticasone in young children when delivered by an antistatic chamber/mask. J Pediatr 2006;149:793-7.

129. Workgroup on EMS Management of Asthma Exacerbations. A model protocol for Emergency Medical Services management of asthma exacerbations. Prehosp Emerg Care 2006;10:418-29.

130. Hendeles L, Colice GL, Meyer RJ. Withdrawal of albuterol inhalers containing chlorofluorocarbon propellants. N Engl J Med 2007;356:1344-51. 131. Hatton RC, Winterstein AG, McKelvey RP, Shuster J, Hendeles L. Efficacy and safety of oral phenylephrine: systematic review and meta-analysis. Ann Pharmacother 2007;41:381-90.

132. Borowitz D, Konstan MW, O’Rourke A, Cohen M, Hendeles L, Murray FT. Coefficients of fat and nitrogen absorption in healthy subjects and individuals with cystic fibrosis. J Pediatr Pharmacol Ther 2007;12:47-52.

133. Hendeles L, Sorkness CA. Anti-Immunoglobulin E therapy with omalizumab for asthma. Ann Pharmacother 2007;41:1397-410.

EDITORIALS AND COMMENTARIES

1. Hendeles L. Wandering from bed to bed. Drug Intell Clin Pharm 1975;9:270-271.

2. Hendeles L, Weinberger M. Dyphylline - the "untheophylline" xanthine bronchodilator. Drug Intell Clin Pharm 1977;11:424.

3. Kagan B, Hendeles L. Meningococcal prophylaxis in 1977. Infectious Diseases 1977;7:4.

4. Weinberger M, Hendeles L. Role of dialysis in the management and prevention of theophylline toxicity. Dev Pharmacol Ther 1980;1:26-30.

5. Hendeles L, Weinberger M. Poisoning patients with intravenous theophylline. Am J Hosp Pharm 1980;37:49-50.

6. Hendeles L, Weinberger M. A time to abandon the use of iodides in pulmonary diseases. J Allergy Clin Immunol 1980;66:177-78.

7. Hendeles L. Adjusting theophylline dosage for smokers. J Resp Dis 1983;4:73-74.

8. Hendeles L, Weinberger M. Combined use of theophylline and beta-2 agonists. Immunol Allergy Pract 1983;5:300-04.

9. Hendeles L, Harman E. Should we abandon the notion that calcium channel blockers are potentially useful for asthma? J Allergy Clin Immunol 1987;79:853-56.

10. Weinberger MW, Hendeles L. Reassessing the therapeutic range for theophylline: Another Curriculum Vitae Leslie Hendeles Page 14

perspective. Pharmacotherapy 1993;13:598-01.

11. Hendeles L, Marshik P. Zileuton: A new therapy for asthma or just the first of a new class of drugs? Ann Pharmacother 1996;30:873-75.

12. Hendeles L. Cetirizine: A new antihistamine with minimal sedation. Pharmacotherapy 1996;16;967-68.

13. Hendeles L, Marshik P. Zafirlukast for chronic asthma: safe, convenient but is it effective? Ann Pharmacother 1997;31:1084-86.

14. Hendeles L, Segal R. Pharmacoeconomic studies of asthma controller drugs: marketing gimmick or icing on the cake? Pharmacother 2002;22:131-3.

15. Hendeles L, Altenburger KM, Benton T. Self-administration at school of prescribed medications for asthma and anaphylaxis. J Pediatr Pharmacol Ther 2003;8:250-1.

16. Hendeles L. Fifty years ago in The Journal of Pediatrics -- Aminophylline (theophylline ethylenediamine) poisoning in children. J Pediatr 2006;149:361.

EDITOR FOR JOURNAL SUPPLEMENTS

1. Hendeles L (Guest Editor) and Scheife RT (Editor). Clinical use of decongestants. Pharmacotherapy 1993;13:1015-465.

2. Hendeles L (Guest Editor) and Scheife RT (Editor). New Frontiers in asthma therapy: Leukotriene receptor antagonists and 5-lipozxygenase inhibitors. Pharmacotherapy 1997;12:1S-54S.

OTHER ARTICLES (NON-REFEREED JOURNALS)

1. Hendeles L. Drug therapy of allergic rhinitis. Iowa Pharmacist 1977;32:10-11.

2. Hendeles L, Weinberger M. The interaction of theophylline and erythromycin. US Pharmacist 1978;3:10-11.

3. Weinberger M, Hendeles L. Formulation and dosage requirements for theophylline in the treatment of asthma. Curr Med Res Opin 1979(suppl 6):6:116-130.

4. Weinberger M, Hendeles L. How to keep serum levels in the therapeutic range: practical guide to using theophylline. J Resp Dis 1981;2:12-27.

5. Hendeles L. OTC metaproterenol. Fla Pharm J 1983;47:4-6.

6. Hendeles L, Weinberger M. Measurement of theophylline serum concentrations in the physician's office. Immunol Allergy Pract 1984;6:104-10.

7. Hendeles L, Weinberger M. Slow-release theophylline for the management of chronic asthma. Singapore Med J 1985;26:83-90.

8. Anonymous. Drugs for Asthma. The Medical Letter 1987;29:11-16.

Curriculum Vitae Leslie Hendeles Page 15

9. Hendeles L. Asthma therapy: state of the art, 1988. J Respir Dis 1988;3:82-08.

10. Hoppe MM, Iafrate RP, Hendeles L, Neims A. A pediatric drug dosing and monitoring guide. Fl J Hosp Pharm 1988;8:259-69.

11. Hendeles L, Weinberger M. Pharmacokinetic basis for the selection of a slow-release theophylline product. Proceedings from the International Colloquium of Progress in Pulmonary Medicine in Cannes, France, Pracon, Inc., Reston VA, October, 1988.

12. Hendeles L. Slow-release theophylline: Do not substitute. Am Pharm 1989;182:22-24.

13. Hendeles L. Switch Candidates from the Pulmonary Perspective. Drug Information 1990;24:83-89.

14. Knudsen AK, Hendeles L, Williams RB. Selecting generic drugs and generic drug vendors: a guide for Florida pharmacists. J Fla Pharm Assoc 1990;54:10-13.

15. Hendeles L, Weinberger M. Theophylline - a model for therapeutic drug monitoring. Proceedings of the 1st Pan Pacific - Asian Congress of Clinical Pharmacy. Penang, Malaysia November 1990.

16. Anonymous. Drugs for ambulatory asthma. Medical Letter 1991;33:9-12.

17. Hendeles L. Bronchoconstrictors may damage lung function when administered repetitively. Board of Pharmacy Newsletter, Florida Department of Health 1998;1:6.

18. Hendeles L. Montelukast for persistent asthma. Florida Pharmacy Today, 1999;63:12-4 and 30.

19. Hendeles L. Dose selection and dosing interval determination for LTRA use in asthma. Postgrad Med, September 2000(special issue):12-21.

20. Sherman J, Hendeles L. Practical pharmacotherapy for pediatric asthma. Pediatr Ann 2000;29:768-73.

21. Carroll RC, Hendeles L. Pancreatic enzyme supplementation in cystic fibrosis patients. U.S. Pharmacist, January 2002;27:HS 34, 37-38, 42-43.

22. Hendeles L. Can pharmacist-compounded tobramycin be substituted for TOBI? University of Florida Pediatric Pulmonary Cystic Fibrosis Newsletter. Summer, 2005.

ELECTRONIC MEDIA

1. Hendeles L, Weinberger M. Pharmacotherapy of Asthma: A Primer for Pharmacists. Glaxo Wellcome Trends in Pharmacy April 1997 (on Website): www.helix.com/member /news/trends pharm/April 97/April97_ce.htar

2. Hendeles L and Weinberger M. Theophylline Use in Asthma. UPTODATE in Pulmonary and Critical Care Medicine, American Thoracic Society, 2007 (CD Rom).

BOOKS

1. Merkus FWHM, Hendeles L (eds): Sustained-Release Theophylline: A Biopharmaceutical Challenge to a Clinical Need. Amsterdam, Excerpta Medica, 1983.

BOOK CHAPTERS AND MONOGRAPHS

1. Hendeles L. Venereal diseases, in Gerbino P (ed): Self Assessment of Current Knowledge in Clinical Pharmacy. Flushing, NY, Medical Examination Publishing Co, 1974, pp 114-121. Curriculum Vitae Leslie Hendeles Page 16

2. Tatro D, Hendeles L. Adverse drug reactions in children, in Gillis S, Kagan BM (eds): Current Pediatric Therapy - 7. Philadelphia, WB Saunders, 1975, pp 687-692.

3. Hendeles L, Weinberger M. Treatment of chronic obstructive lung disease, in Gerbino P (ed): Self Assessment of Current Knowledge of Clinical Pharmacy, ed 2. Flushing, NY, Medical Examination Publishing Co, 1978, pp 192-215.

4. Weinberger M, Hendeles L. Antiasthmatic drugs, in Miller R, Greenblatt D (eds), Handbook of Drug Therapy. New York, Elsevier/North Holland, 1979, pp 927-951.

5. Weinberger M, Hendeles L. Pharmacotherapy of asthma, in Miller RR, Greenblatt D (eds), Drug Therapy Reviews, New York, Elsevier/North Holland, 1979, vol 2, pp 1-23.

6. Weinberger M, Hendeles L. Asthma, in Gillis S, Kagan BM (eds), Current Pediatric Therapy, ed 9. Philadelphia, WB Saunders, 1980, pp 631-640.

7. Weinberger M, Hendeles L. Pharmacologic management of asthma rhinitis, anaphylaxis and urticaria, in Bierman CW, Pearlman DS (eds), Allergic Diseases of Infancy, Childhood and Ado- lescence. Philadelphia, WB Saunders, Philadelphia, 1980, pp 311-332.

8. Hendeles L, Weinberger M, Johnson G. Theophylline, in Jusko W, Schentag J, Evans W (eds), Applied Pharmacokinetics. San Francisco, Applied Therapeutics, Inc, 1980, pp 95-138.

9. Ahrens R, Hendeles L, Weinberger M. Clinical pharmacology of drugs used in the treatment of asthma, in Yaffe SJ (ed), Pediatric Pharmacology. New York, Grune and Statton Inc, 1980, pp 233- 280.

10. Weinberger M, Hendeles L, Ahrens R. Clinical pharmacology of drugs used for asthma. Pediatr Clin N Am 1981;28:47-75.

11. Weinberger M, Hendeles L, Johnson G. Rationale and procedures for measuring serum levels of theophylline, in Baer D, Dito W (eds), Interpretation of Therapeutic Drug Monitoring. Chicago, Am Soc Clin Pathologists, 1981, pp 98-137.

12. Hendeles L, Weinberger M. Theophylline: therapeutic use and serum concentration monitoring, in Taylor WJ, Finn AL (eds), Individualizing Drug Therapy. Practical Applications of Drug Monitoring. New York, Gross, Townsend, Frank, 1981, pp 31-65.

13. Weinberger M, Hendeles L, Ahrens R. Pharmacologic management of reversible obstructive airways disease. Med Clin N Am 1981;65:579-613.

14. Weinberger M, Hendeles L. Asthma in childhood, in Conn HF (ed), Current Therapy. Philadelphia, WB Saunders, 1982, pp 589-597.

15. Hendeles L, Weinberger M. Theophylline, in Middleton E, Ellis E, Reed C (eds), Allergy: Principles and Practice, ed 2. St. Louis, CV Mosby, 1983, pp 535-574.

16. Weinberger M, Hendeles L. Theophylline, in Petty T (ed), Recent Advances in Respiratory Medicine - 3, Edinburgh, Scotland, Churchill Livingstone, 1983, pp 63-77.

Curriculum Vitae Leslie Hendeles Page 17

17. Hendeles L, Weinberger M. Methods of determining bioavailability of slow-release theophylline products, in Merkus FWHM, Hendeles L (eds), Sustained Release Theophylline: A Biophar- maceutical Challenge to a Clinical Need. Amsterdam, Excerpta Medica, 1983, pp 118-135.

18. Weinberger M, Hendeles L. The importance of the absorption characteristics of theophylline in clinical practice, in Merkus FWHM, Hendeles L (eds), Sustained-Release Theophylline: A Biopharmaceutical Challenge to a Clinical Need. Amsterdam, Excerpta Medica, 1983, pp 155-168.

19. Hendeles L, Weinberger M. Measurement of theophylline serum concentrations in the physician's office, in Jonkman JHG, Jenne JW, Simons FER (eds), Sustained Release Theophylline in the Treatment of CRAO. Amsterdam, Excerpta Medica, 1984, pp 41-48.

20. Weinberger M, Hendeles L. Theophylline for chronic asthma: rationale for treatment, product selection and dosage schedule, in Jonkman JHG, Jenne JW, Simons FER (eds), Sustained Release Theophylline in the Treatment of CRAO. Amsterdam, Excerpta Medica, 1984, pp 131-142.

21. Weinberger M, Hendeles L. Use of theophylline for asthma, in Clark TJH, Godrey S (eds), Asthma. London, Chapman and Hill, 1984, pp 336-358.

22. Weinberger M, Hendeles L. Methylxanthines, in Weiss EB, Segal MS, Stein MS (eds), Bronchial Asthma: Mechanisms and Therapeutics. Boston, Little, Brown & Co, 1985, pp 646-674.

23. Hendeles L, Weinberger M. Slow-release oral bronchodilators for prophylactic therapy of chronic asthma, in Prescott LF, Nimmo WS (eds) Rate Control in Drug Therapy. Edinburgh, Scotland, Churchill Livingstone, 1985, pp 254-264.

24. Hendeles L, Massanari MJ, Weinberger M. Theophylline, in Evans WE, Schentag JJ, Jusko WJ (eds), Applied Pharmacokinetics, ed 2. San Francisco, Applied Therapeutics Inc. 1986, pp 1105- 1188.

25. Ellis E, Hendeles L. in Taylor WJ, Cavaness MHD (eds), A Textbook for the Clinical Applications of Therapeutic Drug Monitoring, Abbott Laboratories, Diagnostics Division, Irving, TX, 1986, pp 185- 201.

26. Weinberger M, Hendeles L. in Bierman CW, Pearlman DS (eds), Allergic Diseases from Infancy to Adulthood, ed 2. Philadelphia, WB Saunders, 1988, pp 253-278.

27. Hendeles L, Massanari M, Weinberger M. Theophylline, in Middleton E, Reed CE, Ellis EF, Adkinson NF, Yunginger JW (eds), Allergy: Principles and Practice, ed 3. St. Louis, CV Mosby, 1988, pp 673-714.

28. Iafrate RP, Hendeles L. Asthma, in Herfindal ET, Gourley DR, Hart LL (eds), Clinical Pharmacy and Therapeutics, ed 4. Baltimore, Williams & Wilkins, 1988, pp 354-373.

29. Weinberger M, Hendeles L. Theophylline, in Middleton E, Reed CE, Ellis EF, Adkinson NF, Yunginger JW, Busse WW (eds), Allergy: Principles and Practice, ed 4. St. Louis, CV Mosby, 1993, pp 816-855. Curriculum Vitae Leslie Hendeles Page 18

30. Weinberger M, Hendeles L. Theophylline and Phosphodiesterase Inhibitors, in Middleton E, Reed CE, Ellis EF, Adkinson NF, Yunginger JW. (eds), Allergy: Principles and Practice, ed 5. St. Louis, CV Mosby, 1998, pp 589-611.

31. Hayden ML, Hendeles L, Ortiz G. Diagnostic Challenges in Allergic Rhinitis: Monograph #1, Pragmaton Office of Medical Education, 2001.

32. Hayden ML, Hendeles L, Ortiz G. Improving the Outcomes of Allergic Rhinitis Treatment: Monograph #2, Pragmaton Office of Medical Education, 2001.

LETTERS IN LAST 5 YEARS

1. Hendeles L. Unapproved generic pancreatic enzymes. J Pediatr Pharmacol Ther 2001;6:10-11.

2. Asmus MJ, Hendeles L, Ahrens RC, Clarke WR, Nielsen LP, Dahl R. Therapeutic ratio of inhaled corticosteroids: fact or fiction? Am J Respir Crit Care Med 2001;164:1998-9.

3. Asmus MJ, Hendeles L, Weinberger M, Ahrens RC, Bisgaard H, Lötvall J, O’Byrne PM, Cockcroft DW. Levalbuterol has not been established to have therapeutic advantage over racemic albuterol. J Allergy Clin Immunol 2002;110:325.

4. Hendeles L, Hartzema A. Levalbuterol is not more cost-effective than albuterol for COPD. Chest 2003;124:1176.

5. Weinberger M, Hendeles L. Levalbuterol. Ann Allergy Asthma Immunol 2003;91:587-8.

6. Hendeles L, Hatton RC. Oral phenylephrine: an ineffective replacement for pseudoephedrine? J Allergy Clin Immunol 2006;118:279-80.

7. Meyer RJ, Hendeles L, Colice GL. Albuterol inhalers. N Engl J Med 2007;356:2749.

ABSTRACTS

1. Hendeles L, Khan Y, Massanari M, Spencer T, Shuster J, Chesrown S. The effect of omalizumab on airway responsiveness to adenosine in asthma patients with poor adherence to inhaled steroids. Presented at the 2007 Annual Meeting of the American Thoracic Society, San Francisco, California, May, 2007.

2. Blake K, Hendeles L, Spencer T, Mehta R, Beerahee M, Daley-Yates P, Kunka R. Systemic exposure following fluticasone propionate metered dose inhaler using hydrofluoroalkane propellant with valved holding chambers and face-masks in pre-school children. Presented at the 2006 Annual Meeting of the American College of Clinical Pharmacy, St. Louis, Missouri, October 29, 2006.

Curriculum Vitae Leslie Hendeles Page 19

3. Mack CL, Zineh I, Hendeles, L. Systemic cytokine balance differs between asthma patients with and without positive response to adenosine bronchoprovocation. Presented at the 2006 Annual Meeting of the American College of Clinical Pharmacy, St. Louis, Missouri, October 27, 2006.

4. Khan YR, Hochhaus G, Spencer T, Shuster J, Hendeles L. Relative amount of fluticasone delivered by HFA-MDI to children of different ages. J Allergy Clin Immunol 2006;117:S91.

5. Asmus MJ, Hochhaus G, Tang Y, Spencer LT, Chesrown SE, Hendeles L. Impact of new anti-static valved-holding chamber on airway delivery of inhaled fluticasone propionate in asthmatic children. Am J Respir Crit Care Med 2004;169:A150.

6. Asmus MJ, Hochhaus G, Tang Y, Chesrown SE, Hendeles L. Effect of MDI valved holding chamber antistatic coating on bioavailability of inhaled fluticasone in subjects with asthma. Am J Respir Crit Care Med 2004;169:A313.

7. Ward M, Weitzel KW, Hendeles L, Asmus MJ, Van Riper BW. Evaluation of existing patient data from a community pharmacy-based asthma program. J Am Pharm Assoc 2004;44:262-3.

8. Dugan BD, Weitzel KW, Asmus MJ, Hendeles L, Buie B, Van Riper BW, Chesrown SE. Comparison of pharmacy refill history versus spirometry as an indicator of asthma control in community pharmacy practice. J Am Pharm Assoc 2004;44:233-4.

9. Hendeles L, Erb TA, Bird S, Hustad CM, Edelman JM. Post-exercise response to albuterol after addition of montelukast or salmeterol to inhaled fluticasone. J Allergy Clin Immunol 2004;113(suppl):S34.

10. Wubbel C, Asmus MJ, Chesrown SE, Hendeles L, Comparison of the two ATS-recommended methacholine challenge tests (MCT). Am J Respir Crit Care Med 2003;167:A635.

11. Ahrens RC, Hendeles L, Teresi ME, Lux CR, Vanden Burgt J, Hart KA, Ekholm BP. Relative potency of beclomethasone propionate (BDP), delivered by HFA-MDI, and fluticasone propionate (FP) delivered by diskus. Eur Respir J 2003;22(suppl 45):236s.

12. Asmus MJ, Liang J, Chesrown SE, Hendeles L. Efficacy of albuterol delivery by Pari LC-Star nebulizer. J Allergy Clin Immunol 2002;109:S242.

13. Liang J, Asmus MJ, Hochhaus G, Chesrown SE, Hendeles L. Relative amount of inhaled fluticasone delivered to the airways of asthmatic children by two similar MDI chambers. J Allergy Clin Immunol 2002;109:S242.

14. Bessmertney O, Liang J, Hochhaus G, Chesrown S, Hendeles L. Fluticasone propionate (FP) plasma concentrations in children with asthma. Am J Respir Crit Care Med 2001;163:A518.

15. Patel P, Hutson A, Sherman J, Chesrown S, Hendeles L. Do children with asthma take oral montelukast more consistently than inhaled fluticasone? Pharmacotherapy 2000;20:1267-8.

16. Teresi M, Wilson J, Scher H, Han S-H, Flewelling J, Sherman J, Hendeles, L, Ahrens R. Airway responsiveness to allergen and histamine as a bioassay for comparing inhaled corticosteroid Curriculum Vitae Leslie Hendeles Page 20

preparations. Am J Resp Crit Care Med 1997;155:A353.

SELECTED PRESENTATIONS

1. IV Aminophylline Dosing for Revised Package Insert. FDA Pulmonary-Allergy Drugs Advisory Committee. Bethesda, MD, November 1976.

2. OTC Inhaled Metaproterenol. FDA Pulmonary-Allergy Drugs Advisory Committee Meeting. Bethesda, MD, May 1983.

3. Merrell-Dow Lecturer in Clinical Pharmacy, University of Manchester, Manchester, England, May 1991.

4. Efficacy of Antihistamines for Cold Symptoms. Testimony before the House Subcommittee on Human Resources and Intergovernmental Relations. Conducted by Congressman Ted Weiss. Washington D.C., April 1992.

5. Howard Q. Ferguson Pharmacotherapy Lecture Award, University of North Carolina School of Pharmacy, Chapel Hill, NC, March 1994.

6. Daniel Simmons Honorary Lecturer, UCLA Department of Medicine, Los Angeles, CA, September 1999.

7. Use of Nocturnal Asthma to Evaluate Bronchodilation, FDA-Visiting Scientist Program, Rockville, MD, August, 2000.

8. Recommendations for Pancreatic Enzymes, CF Foundation Pediatric Nutrition Consensus Conference, Bethesda, MD, March, 2001.

9. Cytokine Modulation as Novel Therapy for Asthma, International Congress of Pediatric Pulmonology, Nice, France, February, 2002.

10. Delivery of Inhaled Medications to Young Children with Asthma, Visiting Professor Lecture Series, US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Rockville, MD, October, 2002.

11. New CFC-Free Asthma Inhalers -- What You Need to Know and Optimizing the Delivery of Inhaled Medications, NHLBI National Conference on Asthma 2003 Grand Rounds, Washington, D.C., June, 2003.

12. Role of Health-System Pharmacists in Asthma, National Asthma Education and Prevention Program, Coordinating Committee Meeting, Bethesda, MD, December. 2003.

13. Pharmaceutical Care for Asthma, Sixth Annual Kuwait Pharmaceutical Association Conference, Kuwait, February, 2004.

14. ICS Pharmacokinetics: The Impact of Safety and Efficacy, American Academy of Allergy Asthma and Immunology Annual Meeting, San Antonio, TX, March, 2005. Curriculum Vitae Leslie Hendeles Page 21

15. Study Designs for Bronchodilators and ICS Pharmacokinetics, American Academy of Asthma, Allergy & Immunology Annual Meeting, Miami, FL, March, 2006.

16. Update in Asthma Management, 14th World Congress for Bronchology, Buenos Aires, Argentina, June, 2006.

GRANTS AND CONTRACTS

(available upon request)

RESEARCH FELLOWS AND TRAINEES

(available upon request) Günther Hochhaus

Address: College of Pharmacy, Box 100494 University of Florida Gainesville, Florida, 32610 Tel. (352) 273 7861; FAX (352) 392 4447 [email protected]

Personal Data: Place of Birth: Paderborn, Germany (12/12/1955) Nationality: German Marital Status: Married, 1984

Education: 1975-1979 Undergraduate Student in Pharmacy Westf. Wilhelms - Universität, Münster, FRG 1979 State Examination in Pharmacy (B.Sc.) 1979-1980 Practical Pharmacy Education Elisabeth Apotheke, Detmold, FRG 1980-1984 Graduate Studies at the Institute of Pharm. Chem. (Ph.D.) 1994 GLP Short Course

Positions held: Oct. 1980 - Nov. 1984 Teaching Assistant for Pharm. Chemistry and Biochemistry, Westf. Wilhelms Universitaet Jan. 1985 - June 1987 Postdoctoral Research Pharmacologist Department of Pharm. Chemistry, School of Pharmacy, Univ. of California, San Francisco, Group Leader: Prof. Dr. W. Sadee July 1987 - July 1992 Assistant Professor of Pharmacy, Department of Pharmaceutics, University of Florida, Gainesville July 1992-July 2001 Associate Professor of Pharmacy, University of Florida July 1999-present Adjunct Faculty at the Engineering Research Center July 2001-present Professor of Pharmacy, University of Florida Professional Licensures: “Approbation Apotheker”, Muenster, 1983

Scientific/Professional Societies: Member of American Association of Pharmaceutical Scientists Member of American Association for the Advancement of Science Member of the European Federation for Pharmaceutical Sciences

Services to Scholarly and Professional Journals: Professional Organizations: Regent of the American College of Clinical Pharmacology (1999-2005) Chairman, Honors & Award Committee, American College of Clinical Pharmacology (2000-2005) Editorial Advisory Board: J. Clin. Pharmacol. AAPS PharmSci. Journal of Pharmacy and Pharmacology Pharmaceutical Research

Referee: J. Chromat.J. Pharmacokin. Biopharm., J. Pharmacol. Res., J. Pharm. Sci. J. Pharmaceut., Clin. Pharmacokin., Eur. J. Clin. Investigations, J. Allergy Clin. Immunology, J. Contr. Rel.

Major University Services: Health Center Institutional Review Board (until 1995) Member of the Health Center Student Conduct Standards Committee. Honary Degrees, UF Distinguished Alumni Awards and Memorials Committee (since 2003)

Awards: Young Investigator Award from the "Deutsche Gesellschaft für Atemwegs und Lungenforschung" (1991) Fellow of the American College of Clinical Pharmacology (1992) Tanabe Young Investigator Award of the American Association of Clinical Pharmacology (1998) Teaching Improvement Award of the Univ. of Florida (1998) Fellow of American Association of Pharmaceutical Scientists (2004)

University of Florida Research Foundation Professorship (2006)

2 Teaching Experience: Responsible for pharmaceutical analysis courses on the graduate level, and the biopharmaceutics and pharmacokinetic class

Research Interests: PK/PD based Design and Evaluation of Pulmonary Delivery Systems for Asthma Drugs, Clinical Trial Simulations, Population pharmacokinetic Approaches Pulmonary Peptide Delivery for Heroin Addiction

PUBLICATIONS

1. Identification of glucocorticoid receptors in normal and adult human lung. G. Hochhaus, P. Rohdewald, H. Möllmann, D. Greschuchna. Res. Exp. Med. 182, 71-78 (1983)

2. Comparison of the glucocorticoid receptor of the human lung with those of other human and bovine target organs. G. Hochhaus, P. Rohdewald, H. Möllmann, W.T. Ulmer. Atemw.-Lungenkrkh. 9, 281-283 (1983)

3. Receptor binding affinities of commercial glucocorticoids to the glucocorticoid receptor of human lung. P. Rohdewald, H. Möllmann, G. Hochhaus. Atemw.-Lungenkrkh. 10, 484-487 (1984)

4. Simultaneous determination of glucocorticoid alcohols, their succinates and hydrocortisone in plasma. P. Rohdewald, J. Rehder, G. Drehsen, G. Hochhaus, H. Derendorf, H. Möllmann. J. Pharm. Biomed. Anal. 3, 565-573 (1985)

5. Glucocorticoid receptors in the respiration tract. P. Rohdewald, H. Möllmann, K.M. Mueller, G. Hochhaus. In: Bochumer Treff 1984, Rezeptoren und nervoese Versorgung des bronchopulmonalen Systems, Verlag Gedon & Reuss, Muenchen, 223-242 (1985)

6. Affinities of glucocorticoids for glucocorticoid receptors in the human lung. P. Rohdewald, H. Möllmann, G. Hochhaus. Agents and Action. 17, 290-291 (1985)

7. HPLC determination of glucocorticoid alcohols, their phosphates and hydrocortisone in biological fluids. H. Derendorf, P. Rohdewald, G. Hochhaus, H. Möllmann. J. Pharm. Biomed. Anal. 4, 197-206 (1986)

8. Delta opiate receptors in human neuroblastoma cell lines. G. Hochhaus, V.C. Yu, W. Sadee. Brain Res. 382, 327-331 (1986)

9. Development of a biotin-avidin probe for detecting opiate receptors. G. Hochhaus, B.W. Gibson, W. Sadee. NIDA Research Monographs. 75, 33-36 (l987)

10. Biotinylated human ß-endorphins as probes for the opiate receptor G. Hochhaus, B.W. Gibson, W. Sadee. J. Biol. Chem. 263, 92-97 (1988)

11. A biotin-avidin based enzyme immunoassay for ßh-endorphin. G. Hochhaus, W. Sadee. Pharm. Res. 5, 232- 235 (1988)

12. Effects of opioid peptides on human neuroblastoma cells. W. Sadee, V.C. Yu, G. Hochhaus. NIDA Research Monograph 87, Opioid peptides: an update. Rao S. Rapaka, Bhola N. Dhawan (eds.). National Institute on Drug Abuse. (1988)

3 13. [Biocytin13]dynorphin A1-13 amide: a potential probe for the k-opioid receptor. G. Hochhaus, A. Patthy, R. Schwieter, D.V. Santi, W. Sadee. Pharm. Res. 5, 790-794 (1988)

14. Neuronal cell differentiation of human neuroblastoma cells by retinoic acid plus herbimycin-A1. P.N. Preis, H. Saya, L. Nadasdi, G. Hochhaus, V. Levin, W. Sadee. Cancer Research. 48, 6530-6534 (1988)

15. Differentiation of human neuroblastoma cells: marked potentiation of PGE1-stimulated accumulation of cyclic AMP by retinoic acid. V.C. Yu, G. Hochhaus, F-H. Chang, M.L. Richards, H. R. Bourne, W. Sadee. J. Neurochem. 51, 1892-1899 (1988)

16. Differential therapeutic aspects of the treatment of toxic gas poisoning with glucocorticoids. H.W. Möllmann, J. Barth, D. Schött, H. Derendorf, G. Hochhaus. Intensivmed. 26, 2-15 (1989)

17. An avidin/biotin based enzyme-linked Immunosorbent assay for dynorphin A1-13. G. Hochhaus, Lase Hu. J. Pharm. Biomed. Anal. 8, 541-545 (1990)

18. Binding affinities of rimexolone (ORG 6216), flunisolide and their putative metabolites for the glucocorticoid receptor of human synovial tissue. G. Hochhaus, H. Möllmann. Agents and Actions. 30, 377- 380 (1990)

19. Absorption and transfer of water-soluble glucocorticoids through pulmonary membranes. J. Barth, A. Möllmann, G. Hochhaus, H. Derendorf, H.W. Möllmann. Atemw.-Lungenkrkh. 15, 412-416 (1989)

20. Oral bioavailability of triamcinolone tablets and a triamcinolone diacetate suspension. G. Hochhaus, M. Pörtner, J. Barth, H. Möllmann, P. Rohdewald. Pharm. Res. 7, 558-560 (1990)

21. Pharmaceutical biotechnology: A new graduate course at the University of Florida College of Pharmacy. H. Schreier, G. Hochhaus, R.J. Prankerd, H. Derendorf, M.E. Brewster, R.A. Baughman. Am. J. Pharm. Educ. 54, 46-50 (1990)

22. Pharmacodynamic aspects of systemic glucocorticoid action (German). J. Barth, H. Möllmann, H. Derendorf, G. Hochhaus. In: Willert, Heuck (eds.), New Results in Osteology, Springer, Heidelberg, 533- 541(1989)

23. Pharmacokinetic aspects of intra-articular glucocorticoid administration (German). H. Derendorf, H. W. Möllmann, P. Rohdewald, D. Strohband, J. Barth, G. Hochhaus. In Willert, Heuck (eds.), New Results in Osteology, Springer, Heidelberg, 474-481, (1989)

24. Glucocorticoids for the intra-articular therapy: Pharmacodynamic characterization via receptor binding studies. G. Hochhaus, H. Möllmann, J. Barth. Akt. Rheumatol. 15, 66-69 (1990)

25. Distribution and aggregation of crystals in glucocorticoid suspensions (German). H.W. Möllmann, B. Armbruster, J. Barth, H. Derendorf, O.W. Flörke, G. Hochhaus, C.R. Möllmann, P. Rohdewald, E.W. Schmidt. Akt. Rheumatol. 15, 101-124 (1990)

26. Fluorescence immunoassay. S. Schulman, G. Hochhaus, H.T. Karnes. In W.R.G. Baeyens (ed.) Luminescence Techniques in Chemical and Biochemical Analysis. Marcel Dekker, New York, 341-380 (1990)

27. cAMP accumulation in opioid sensitive SH-SY5Y neuroblastoma cells is modified by estradiol and progesterone. A. Ratka, G. Hochhaus, R.N. Wissler, J.W. Simpkins. Mol. Cell. Endo. 78, 155-162 (1991)

28. Soft drugs 10: blanching activity and receptor binding affinity of a new type of glucocorticoid: loteprednol etabonate. P. Druzgala, G. Hochhaus, N. Bodor. J. Steroid Biochem. 38, 149-154 (1991)

4 29. Glucocorticoid activity and structure activity relationships in a series of some novel 17 -ether-substituted steroids: influence of 17 -substituents. G. Hochhaus, P. Druzgala, R. Hochhaus, M-J. Huang, N. Bodor. Drug Design and Discovery. 8, 117-125 (1991)

30. Pharmacokinetic/pharmacodynamic correlation of pulmonary and cardiac effects of fenoterol in asthmatic patients after different routes of administration. G. Hochhaus, E.W. Schmidt, K.L. Rominger, H.W. Möllmann. Pharm. Res. 9, 291- 297 (1992)

31. A selective LC/RIA for dexamethasone and its prodrug dexamethasone-21-isonicotinate in biological fluids. G. Hochhaus, H. Derendorf, H. Möllmann, J. Barth. J. Pharm. Biomed. Anal. 9, 761-767 (1991)

32. A new fluorogenic assay for tyrosine-containing peptides. M. Tellier, R.J. Prankerd, G. Hochhaus. J. Pharm. Biomed. Anal. 9, 557-563 (1991)

33. Pharmacokinetic evaluation of a new glucocorticoid soft drug: loteprednol etabonate. G. Hochhaus, L.S. Chen, A. Ratka, P. Druzgala, J. Howes, N. Bodor, H. Derendorf. J. Pharm. Sci. 81, 1210-1215 (1992)

34. A selective HPLC/RIA for dexamethasone and its prodrug dexamethasone-21-sulfobenzoate in biological fluids. G. Hochhaus, R. Hochhaus, G. Werber, H. Derendorf, H. Möllmann. Biomedical Chromatography 6, 283-286 (1992)

35. Analysis of shape, particle size distribution and aggregation of the crystals of intal aerosol, sodium cromoglycate, tilade aerosol and nedocromil sodium. J. Barth, H.W. Möllmann, W. Floerke, B. Armbruster, G. Hochhaus, H. Derendorf. Eur. J. Hosp. Pharm. 3, 20-28 (1993)

36. Receptor-based pharmacokinetic-pharmacodynamic analysis of corticosteroids. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth, M. Krieg, S. Tunn, C. Möllmann. J. Clin. Pharmacol. 33, 115-123 (1993)

37. Generic and alternative brand name pharmaceutical equivalents; substitute with caution! L. Hendeles, G. Hochhaus, S. Kazerounian. Am. J. Hosp. Pharm. 50, 323-329 (1993)

38. Studies on the pharmacokinetics and metabolism of prednicarbate after cutaneous and oral administration. J. Barth, H. Möllmann, K.H. Lehr, T. Höhler, H. Derendorf, G. Hochhaus. Skin Pharmacol. 6, 179-186 (1993)

39. Pharmacokinetics and pharmacodynamics of prednisolone after intravenous and oral administration. J. Barth, M. Damoiseaux, H. Möllmann, K.H. Brandis, G. Hochhaus, H. Derendorf. Int. J. Clin. Pharmacol. Ther. Toxicol. 30, 317-324 (1992)

40. PK/PD analysis of albuterol action: application to a comparative assessment of beta-2-adrenergic drugs. G. Hochhaus, L. Hendeles, E. Harmon, H. Möllmann. Eur. J. Pharm. Sci. 1, 73-80 (1993)

41. Pharmacokinetic/pharmacodynamic characteristics of the beta-2-agonists terbutaline, salbutamol and fenoterol . G. Hochhaus, H. Möllmann. Int. J. Clin. Pharmacol. Ther. Toxicol. 30,342-362 (1992)

42. Prednicarbate after different forms of administration: plasma levels of drug and metabolites and effects on endogenous cortisol levels in humans. J. Barth, G. Hochhaus, H. Derendorf, K.H. Lehr, T. Hoehler, H. Möllmann. Curr. Probl. Dermatol. 21, 147-156 (1993)

43. Topical use of steroids in gastroenterology. H.W. Möllmann, G. Hochhaus, A. Tromm, J. Barth, C. Bigalke, B. May, A.C. Möllmann, U. Schwegler, H. Derendorf, S. Tunn. In: Schoelmerisch, W. Kruis, H. Goebell, W. Hohenberger, V. Gross (eds.), Inflammatory Bowel Diseases-Pathophysiology as Basis of Treatment, Kluwer Academic Publishers, London, 343-349 (1993)

44. Immunoassay. H.T. Karnes, M. A. Sarkar, G. Hochhaus, S.G. Schulman. In: J. Swarbrickand, J.C. Boylan (eds.), Encyclopedia of Pharmaceutical Technology, Volume 8, Marcel Dekker, New York, 31-52 (1993)

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45. Clinical pharmacology of pancreatic enzymes in patients with cystic fibrosis and in-vitro performance of microencapsulated formulations. M. Kraisinger, G. Hochhaus, A. Stecenko, E. Bowser, L. Hendeles. J. Clin. Pharmacol. 34, 158-166 (1994)

46. Bioavailability of hydrocortisone after single und multiple dosing of hydrocortisone foam in patients with distal chronic inflammatory diseases and healthy volunteers. T. Wagner, J. Barth, C. Bigalke, S. Tunn, M. Krieg. H. Derendorf, H. Möllmann, B. May, G. Hochhaus. Aktuelle Koloproktologie 10, 223-226 (1993)

47. Leucine enkephalin-tyrosinase reaction products: Identification by mass spectrometry and biological activity. V. Larsimont, L. Prokai, G. Hochhaus. Biochim. Biophys. Acta 1222, 95-100 (1994)

48. Pharmacokinetics of triamcinolone acetonide after IV, oral & inhaled administration . H. Derendorf, G. Hochhaus, S. Rohatagi, H. Möllmann, J. Barth, M. Erdmann. J. Clin. Pharmacol. 35, 302-305 (1995)

49. Response to commentary on pharmacokinetic characterization and tissue distribution of a new glucocorticoid soft drug loteprednol etabonate in rats and dogs. G. Hochhaus, P. Druzgala, J. Howes, N. Bodor, H. Derendorf. J. Pharm. Sci. 83, 1067-1068 (1994)

50. Assessment of glucocorticoid lung targeting by ex-vivo receptor binding studies. G. Hochhaus, R. Gonzales- Rothi, A. Lukyanov, H. Derendorf, H. Schreier, T. Dalla Costa. Pharm. Res. 12, 134-137 (1995)

51. Dose optimization based on pharmacokinetic/pharmacodynamic modeling. G. Hochhaus, H. Derendorf. In: H. Derendorf, G. Hochhaus (eds.), Handbook of pharmacokinetic/ pharmacodynamic correlations, CRC, New York, 79-120 (1995)

52. Pharmacokinetic-pharmacodynamic correlations of glucocorticoids, H. Möllmann, S. Balbach, G. Hochhaus, J. Barth, H. Derendorf. In: H. Derendorf, G. Hochhaus (eds.), Handbook of pharmacokinetic/ pharmacodynamic correlations, CRC, New York, 323-362 (1995)

53. Beta-agonists: terbutaline, albuterol, and fenoterol. G. Hochhaus, H. Möllmann. In: H. Derendorf, G. Hochhaus (eds.), Handbook of pharmacokinetic/ pharmacodynamic correlations, CRC, New York, 299-322 (1995)

54. Metabolism of dynorphin A1-13 in blood and plasma. S. Mueller, G. Hochhaus. Pharm. Res. 12, 1165-1170 (1995)

55. Pharmacokinetic/pharmacodynamic evaluation of deflazacort in comparison to methylprednisolone and prednisolone. H. Möllmann, G. Hochhaus, S. Rohatagi, J. Barth, H. Derendorf. Pharm. Res. 12, 1096-1100 (1995)

56. Problems with the equivalency of glucocorticoids. A comparison of the pharmacokinetics and pharmacodynamics of prednisolone and methylprednisolone (German). J. Barth, H. Möllmann, G. Hochhaus, H. Derendorf. Dtsch. med. Wschr. 119, 1671-1676 (1994)

57. Thermodynamic and kinetic aspects of the interaction of triamcinolone acetonide with liposomes. H. Schreier, A.N. Lukyanov, G. Hochhaus, R.J. Gonzalez-Rothi. Proceed. Intern. Symp. Control. Rel. Bioact. Mater. 21, 228-229 (1994)

58. Pulmonary targeting of liposomal triamcinolone acetonide phosphate. R. Gonzales-Rothi, S. Suarez, G. Hochhaus, H. Schreier, A. Lukyanov, H. Derendorf, T. Dalla Costa. Pharm. Res. 13, 1699-1703 (1996)

59. Pharmacokinetic interaction between endogenous cortisol and exogenous corticosteroids. S. Rohatagi, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf. Pharmazie 50, 610-613 (1995)

6 60. Concepts of corticosteroid therapy of chronic inflammatory bowel disease: topical vs. systemic administration H. Möllmann, J. Barth, G. Hochhaus, A. Möllmann, H. Derendorf, A. Tromm In “Corticosteroid therapy of chronic inflammatory bowel disease”, B. May and H. Möllmann (eds.), Falk Foundation, 69-90 (1996)

61. Pharmacodynamic aspects of corticosteroid effects. G. Hochhaus, H. Derendorf, H. Möllmann, J. Barth, R. Hochhaus In “Corticosteroid therapy of chronic inflammatory bowel disease”, B. May and H. Möllmann (eds.), Falk Foundation, 91-117 (1996)

62. Wechselseitige beziehungen zwischen pharmakokinetik und pharmakodynamik als grundlage einer rationalen therapie, H. Derendorf, H. Möllmann, G. Hochhaus, J. Barth, In “Glukokortikoidtherapie chronisch entzündlicher Darmerkrankungen” B. May and H. Möllmann (eds.), Falk Foundation, 119-135 (1996)

63. Pharmacokinetics and pharmacodynamics of budesonide-pH-modified release capsules, H. Möllmann, G. Hochhaus, A. Tromm, P. Froehlich, A. Möllmann, M. Krieg, H. Weisser, H. Derendorf, J. Barth In “Corticosteroid therapy of chronic inflammatory bowel disease”, B. May and H. Möllmann (eds.), Falk Foundation, 149-167 (1996)

64. Pharmacodynamic aspects of glucocorticoid action, G. Hochhaus, H. Derendorf, H. Möllmann, J. Barth, R. Hochhaus. Kongressband, IV International Symposium of Inflammatory Bowel Diseases, Kluwer Academic Publishers Dordrecht, Boston, London, 61-79 (1996)

65. Pharmacokinetics and pharmacodynamics of cloprednol, H. Möllmann, G. Hochhaus, S. Rohatagi, J. Barth, H. Derendorf, M. Krieg, H. Weisser, A. Möllmann. Int. J. Clin. Pharmacol. Ther. 34, 1-5 (1996)

66. Kinetic/dynamic interrelationships as basis for rational therapy, H. Derendorf, H.W. Möllmann, G. Hochhaus, J. Barth, Kongressband, IV International Symposium of Inflammatory Bowel Diseases, B. May and H. Möllmann (eds.), Kluwer Academic Publishers, Dordrecht, Boston, London, 80-98 (1996)

67. Principles of topical versus systemic corticoid treatment in inflammatory bowel disease, H.W. Möllmann, J. Barth, G. Hochhaus, IV International Symposium of Inflammatory Bowel Disease, B. May and H. Möllmann (eds.), Kluwer, Academic Publishers, Dordrecht, Boston, London, 42-60 (1996)

68. Pharmacokinetics and pharmacodynamics of budesonide-pH modified release capsules, H.W. Möllmann, G. Hochhaus, A. Tromm, P. Froehlich, A.C. Möllmann, M, Krieg, H. Weisser, H. Derendorf, J. Barth, Kongressband, IV International Symposium of Inflammatory Bowel Diseases, B. May and H. Möllmann (eds.), Kluwer, Academic Publishers, Dordrecht, Boston, London, 107-120 (1996)

69. Pharmacokinetic and pharmacodynamic evaluation of triamcinolone acetonide after intravenous, oral and inhaled administration, S. Rohatagi, G. Hochhaus, H. Möllmann, J. Barth, E. Galia, M. Erdmann, H. Sourgens, H. Derendorf. J. Clin. Pharmacol. 35, 1187-1193 (1996)

70. Interspecies comparison of in-vitro plasma degradation of dynorphin A1-13. S. Mueller, R. Dunker, G. Hochhaus. Die Pharmazie 51, 581-585 (1996)

71. Metabolism of dynorphin A1-13 in human CSF, S. Mueller, B.L. Grundy, G. Hochhaus. Neurochem. Res. 21, 1213-1219 (1996)

72. Pharmacokinetic/pharmacodynamic aspects of aerosol therapy using glucocorticoids as a model, G. Hochhaus, H. Derendorf, H. Möllmann, R. Gonzalez-Rothi. J. Clin. Pharmacol. 37, 881-892 (1997)

73. Pharmacokinetic/pharmacodynamic evaluation of systemic effects of flunisolide after inhalation, H. Möllmann, H. Derendorf, J. Barth, B. Meibohm, M. Wagner, M. Krieg, J. Knoeller, and G. Hochhaus. J. Clin. Pharmacol. 37, 893-903 (1997).

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74. An HPLC/RIA method for dynorphin A1-13 and its main metabolites in human blood, S. Müller, B. Ho, P.L. Gambus, W. Millard, G. Hochhaus. J. Pharm. Biomed. Anal. 16, 101-109 (1997)

75. A selective HPLC/RIA for the determination of budesonide, G. Hochhaus, P. Froehlich, R. Hochhaus, A. Möllmann, H. Derendorf, H.W. Möllmann. J. Pharm. Biomed. Anal., 17, 1235-1242 (1998)

76. Displacement of [3H]-L-glutamate in rat brain membranes by metabolic dynorphin fragments, S. Mueller, F. B. Chang-Sing-Pang, and G. Hochhaus, Die Pharmazie, 53, 142-143 (1998)

77. The pharmacokinetics of i.v. dynorphin A (1-13) in opioid naive and opioid tolerant human volunteers, P.L. Gambus, T.W. Schnider, C.F. Minto, E. Youngs, V. Billard, G. Hochhaus, W.L. Brose, S.L. Shafer. Clin. Pharmacol. Therapeutics, 64, 27-38 (1998)

78. Pharmacodynamic aspects of drug delivery, H. Derendorf, G. Hochhaus. Clin. Pharmacology 15: Aspekte der intestinalen Absorption und der Modellentwicklung in Pharmakokinetik und Pharmacodynamik, ed. By T. Gramatte and M. Weiss, W. Zuckschwerdt Verlag, München, 10-18 (1998)

79. Pharmacokinetic and pharmacodynamic evaluation of fluticasone after inhaled administration, H. Möllmann, M. Wagner, B. Meibohm, G. Hochhaus, J. Barth, C. Falcoz, M. Wagner, H. Derendorf. Eur. J. Clin. Pharmacol., 53, 459-467 (1998)

80. Pharmacokinetics of methylprednisolone and prednisolone after single and multiple oral dosing, S. Rohatagi, J. Barth, H. Möllmann, G. Hochhaus, A. Soldner, H.Derendorf. J. Clin. Pharmacol. 37, 916-925 (1997)

81. Dependency of cortisol suppression on the administration time of inhaled corticosteroids, B. Meibohm, G. Hochhaus, S. Rohatagi, H. Möllmann, J. Barth, M. Wagner, M. Krieg, R. Stöckmann, H. Derendorf. J. Clin.Pharmacol. 37, 704-710 (1997)

82. Clinical PK/PD modeling as a tool in drug development of corticosteroids, H. Derendorf, H. Möllmann, G. Hochhaus, B. Meibohm, J. Barth. Int. J. Clin. Pharmacol.Therapeut. 35, 481-488 (1997)

83. Pharmacokinetics and pharmacodynamics of inhaled corticosteroids. H. Derendorf, G. Hochhaus, B. Meibohm, H. Möllmann, J. Barth. J. Allergy Clin. Immunol. 101 S440-446 (1998)

84. Effect of dose and release rate pulmonary targeting of inhaled on pulmonary targeting of liposomal triamcinolone acetonide. S. Suarez, R.J. Gonzales-Rothi, H. Schreier, G. Hochhaus. J. Pharm. Res., 15, 461- 465 (1998)

85. Pulmonary selectivity of glucocorticoids: How is it influenced by formulation? G. Hochhaus, S. Suarez, R.J. Gonzales-Rothi, H. Schreier, Respiratory Drug Delivery VI, R. Dalby, P. Byron, S.J. Farr, eds, Interpharm Press, Buffalo Grove, IL, 45-52 (1998)

86. Pharmacokinetic and pharmacodynamic aspects of salmeterol therapy, A. Buchwald, G. Hochhaus Int. J. Clin. Pharmacol. Therapeut., 36, 652-660 (1998)

87. The clinical pharmacology of fluticasone propionate. B. Meibohm, H. Möllmann, M. Wagner, G. Hochhaus, A. Möllmann, H. Derendorf. Rev. Contemp. Pharmacother. 8, 535-549 (1998)

88. Salmeterol, langwirkendes inhalatives ß2-Sympathomimetikum, G. Hochhaus, Amy Buchwald, M. Schulz. Pharmz. Zeit. 143, 2318-2324 (1998)

89. Formoterol, langwirkendes inhalatives ß2-Sympathomimetikum, G. Hochhaus, Amy Buchwald, M. Schulz. Pharmz. Zeit. 143, 4354-4361 (1998)

8 90. A PK/PD approach to predict the cumulative cortisol suppression of inhaled corticosteroids, B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, M. Wagner, M. Krieg, R. Stöckmann, H. Derendorf. J. Pharmacokin. Biopharm., 27, 127-147 (1999)

91. Analysis of leucine-enkephalin by HPLC using enzymatic derivatization by tyrosinase and electrochemical or fluorescence detection, V. Larsimont, M. Bogaards, P. Mulleneers, G. Hochhaus. J. Pharm. Biomed. Anal., 19, 855-864 (1999)

92. Mechanism based PK/PD-model for the lymphocytopenia induced by endogenous and exogenous corticosteroids. B. Meibohm, H. Derendorf, H. Möllmann, P. Fröehlich, A. Tromm, M. Wagner, M. Krieg, G. Hochhaus. Int. J. Clin. Pharmacol. Therapeut., 37, 367-376 (1999)

93. Assessment of complex peptide degradation pathways via structured multi-compartmental modeling approaches: the metabolism of dynorphin A1-13 and related fragments in human plasma, S. Müller, A. Hutson, V. Arya, G. Hochhaus. J. Pharm. Sci., 88, 938-944 (1999)

94. Kinetic modeling of plasmid DNA degradation in rat plasma. B.E. Houk, G. Hochhaus, J.A. Hughes. AAPS PharmSci. 1, issue 4 (1999)

95. Pharmacokinetic considerations in the design of pulmonary drug delivery systems for glucocorticoids. C. Mobley, G. Hochhaus . In: H. Schreier (ed.), Drug Targeting Technology, Marcel Dekker, New York, 51- 83 (2001)

96. Pharmacokinetics and pharmacodynamics of dexamethasone sodium-m-sulfobenzoate (DS) after intravenous and intramuscular administration: a comparison with Dexamethasone Phosphate (DP). G. Hochhaus, J. Barth, S. Al-Fayoumi, S. Suarez, H. Derendorf, R. Hochhaus, H. Möllmann. J. Clin. Pharmacol. 41:425-434 (2001)

97. Nano-thin coatings for improved lung targeting of glucocorticoid dry powders: In-vitro and In-vivo characteristics. J. Talton, J. Fitz-Gerald, R. Singh, G. Hochhaus. Respiratory Drug Delivery VII, R. Dalby, P. Byron, S.J. Farr, eds, Interpharm Press, Buffalo Grove, IL, 67-74 (2000)

98. Loteprednol etabonate: a soft steroid for the treatment of allergic diseases in the airways. I. Szelenyi, G. Hochhaus, S. Heer, S. Küsters, D. Marx, H. Poppe, J.Engel. Drugs of Today, 36, 313-320 (2000)

99. Factors involved in the pulmonary targeting of inhaled glucocorticoids: the use of pharmacokinetic/dynamic simulations. G. Hochhaus, H. Derendorf, J. Talton, H. Moellmann. Inhaled Steroids in Asthma, Lung Biology in Health and Disease, Volume 163, R.P. Schleimer, P.M. O'Byrne, S.J. Szefler, R. Brattsand. (eds); Marcel Dekker, New York, 283-305 (2001)

100. Systemic disposition and effects of inhaled corticosteroids. H. Derendorf, G. Hochhaus, S. Krishnaswami. Inhaled Steroids in Asthma, Lung Biology in Health and Disease, Volume 163, R.P. Schleimer, P.M. O'Byrne, S.J. Szefler, R. Brattsand. (eds); Marcel Dekker, New York, 247-270 (2001)

101. A sensitive LC-MS/MS method for the quantification of fluticasone propionate in human plasma. S. Krishnaswami, H. Möllmann, H. Derendorf, G. Hochhaus. J. Pharm. Biomed. Analysis 22, 123-129 (2000)

102. Methods to assess pulmonary deposition and absorption of drugs. C. Mobley, G. Hochhaus. Drug Discovery Today, 6:367-375 (2001)

103. Evolution of pharmacokinetics and pharmacokinetic/dynamic correlations during the 19th century. G. Hochhaus, J. Berratt, H. Derendorf. J. Clin. Pharmacol. 40, 908-917 (2000)

104. Pharmacokinetic modeling of plasmid DNA degradation in rats. B.E. Houk, G. Hochhaus, J.A. Hughes. Pharm. Res. 18;67-74 (2001).

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105. Fluticasone propionate: first long acting inhaled corticosteroid-analysis of clinical studies based on its pharmacokinetic profile. M. Wagner, R. Stöckmann, AC Möllmann, G. Hochhaus, H. Derendorf, J. Barth, HW Moellmann. Atemwegs uund Lungenerkrankungen, 25, 580-598 (1999)

106. Optimized therapeutic ratio of inhaled corticosteroids using retrometabolism. H. Derendorf, G. Hochhaus, S. Krishnaswami, B. Meibohm, H. Möllmann, Pharmazie 55, 223-227 (2000).

107. An interactive algorithm for the assessment of cumulative cortisol suppression during inhaled corticosteroid therapy. S. Krishnaswami, G. Hochhaus, H. Moellmann, H. Derendorf. AAPS PharmSci, 2, article 22 (http://www.pharmsci.org/)

108. Evaluation of pulmonary absorption using pharmacokinetic methods. H. Derendorf, G. Hochhaus, H. Moellmann. J. Aerosol Med. 14, Suppl.1, S9-S18 (2001)

109. Pharmacokinetics and rectal bioavailability of hydrocortisone acetate after single and multiple administration in healthy subjects and patients. A. Tromm, H. Moellmann, J. Barth, G. Hochhaus, M. Krieg, C. Bigalke, A. Moellmann, H. Derendorf. J. Clin. Pharmacol. 41 536-541 (2001)

110. Single dose and steady state pharmacokinetic and pharmacodynamic evaluation of therapeutically equipotent doses of inhaled fluticasone propionate and budesonide in healthy subjects. H. Möllmann, M. Wagner, S. Krishnaswami, H. Dimova, Y. Tang, C. Falcoz, P.T. Daley-Yates, M. Krieg, R. Stöckmann, J. Barth, A.C. Möllmann, H. Derendorf, G. Hochhaus. J Clin Pharmacol, 41, 1329-1338 (2001)

111. Systemic Disposition and Effects of inhaled Corticosteroids. , H. Derendorf, G. Hochhaus, S. Krishinaswami, H. Moellmann. Inhaled Steroids in Asthma, Lung Biology in Health and Disease, Volume 163, R.P. Schleimer, P.M. O'Byrne, S.J. Szefler, R. Brattsand. (eds); Marcel Dekker, New York, 247-272 (2001)

112. Current concepts in pharmacokinetics and their implications for clinical medicine. M. Mueller, G. Hochhaus, H. Derendorf. Wien.Klin.Wochenschr. 15/16: 566-572 (2001)

113. Fluticasone propionate plasma concentrations after a metered-dose inhaler in children. O. Bessmertny, J. Liang, G. Hochhaus, S. Chesrown, L. Hendeles. J. Pediatr. Pharmacol. Ther. 6, 212-217 (2001)

114. Receptor binding studies of soft anticholinergic agents. F. Huang, P. Buchwald, C.E Browne, H.H. Farag, W. Wu, G. Hochhaus, N.Bodor. AAPS PharmSci, 3, article 30, 2001 (http://www.pharmsci.org)

115. A New Solution Based Intranasal Triamcinolone Acetonide Formulation In Patients With Perennial Allergic Rhinitis: How Does The PK/PD Profile For Cortisol Suppression Compare With An Aqueous Suspension Based Formulation? G. Hochhaus, M. A. Gonzalez, J. Shilstone, J. Karafilidis. J. Clin Pharmacol. 42:662- 669 (2002)

116. SPE/RIA vs LC/MS for the measurement of low levels of budesonide in plasma. H. Dimova, Y. Wang, S. Pommery, H. Möllmann, G. Hochhaus. Biomedical Chromatography 17, 14-20 (2003)

117. In-Vitro deposition of fluticasone aerosol from a metered-dose inhaler with and without two common valved holding chambers. MJ Asmus , J. Liang , I. Coowanitwong , R Vafadari, G. Hochhaus. Annals of Allergy, Asthma, & Immunology 88:204-208 (2002)

118. Differences in inhaled fluticasone bioavailability between holding chambers in children with asthma. J. Liang, M.J Asmus., G. Hochhaus, S. Chesrown, L. Hendeles. Pharmacotherapy. 2002;22, 947-953 (2002)

10 119. Performance of a corticosteroid inhaler with a spacer fashioned from a plastic cold-drink bottle: Effect of changing bottle volume. S.A. Taylor, M..J Asmus , J. Liang , I. Coowanitwong , R. Vafadari, G. Hochhaus. J Asthma 40, 237-242 (2003)

120. Intranasal glucocorticoid delivery competition between local and systemic effects. G. Hochhaus, S. Sahasranaman, H. Derendorf, H. Moellmann. S.T.P. Pharma Sciences 12, 23-31 (2002)

121. In-vitro and in-vivo anti-inflammatory activity of ciclesonide, a novel on-site activated glucocorticoid. M. Stoeck, R. Rieder, G. Hochhaus, D. Haefner, J.M. Masso, A. Hatzelmann, D. Marx, D. S. Bundschuh. JPET. 309, 249-258 (2004)

122. Population pharmacokinetics and pharmacodynamics of ciclesonide. S. Rohatagi, V. Arya, K. Zech, R. Nave, .JS. Barrett, G. Hochhaus, BK Jensen and J.S. Barrett, J. Clin. Pharmacol., 43, 365-378 (2003)

123. Pharmacokinetics of the dietary supplement creatine. A. Persky, G. Brazeau, G. Hochhaus. Clin. Pharmacokinetics 42, 557-574 (2003)

124. Validation of a simple liquid chromatography assay for creatine suitable for pharmacokinetic applications, determinations of plasma protein binding and verification of percent labeled claim of various creatine products.. A. Persky, G. Hochhaus, G. Brazeau. J. Chromatography B 794, 157-165 (2003)

125. Single and multiple dose pharmacokinetics of creatinine. A. Persky, M. Müller, H. Derendorf, M. Grant, G. Brazeau, G. Hochhaus. J Clin. Pharmacol. 43: 29-37 (2003)

126. Simultaneous quantification of budesonide, and its two metabolites, 6 -hydroxybudesonide and 16 - hydroxyprednisolone, in human plasma by liquid chromatography electrospray ionization tandem mass spectrometry.Y. Wang, Y. Tang, H. Moellmann, G. Hochhaus. Biomedical Chromatography 17, 158-163 (2003)

127. Pharmacokinetic and pharmacodynamics of drugs delivered to the lungs. M. Issar, C. Mobley, P. Khan, G. Hochhaus. In: Pharmaceutical Inhalation Aerosol Technology, second edition. A. Hickey (ed), 215-252, 2003, Marcel Dekker, New York.

128. Pharmacokinetic/pharmacodynamic modeling of total lymphocytes and selected subtypes after oral budesonide. J. Stark, S. Werner, S. Homrighausen, H. Derendorf, H. Moellmann, G. Hochhaus J. Pharmacokin. Pharmacodyn 33:441-459 (2006)

129. Laser based synthesis of nanofunctionalized particulates for pulmonary based controlled drug delivery application. R.K. Singh, W.-S. Kim, M. Ollinger, V. Craciun, I Coowanitwong, G. Hochhaus, N. Koshizaki. Applied Surface Science, 197-198, 610-614 (2002)

130. Pharmacokinetics and pharmacodynamics of omalizumab (Xolair ): implications for clinical efficacy and dosing. G. Hochhaus, L. Brookman, Y. Deniz, H. Fox. Current Medical Research and Opinion, 19, 491-498 (2003)

131. In vitro performance of two common valved holding chamber with a chlorofluorocarbon-free beclomethasone metered-dose inhaler. Asmus MJ, Kwon SH, Coowanitwong I, Khorsand N, Hochhaus G. Pharmacotherapy. 23, 1538-1544 (2003).

132. Pharmacokinetic aspects of biotechnology products. L. Tang, A. Persky, G. Hochhaus, B. Meibohm, J. Pharm. Sci. 9, 2184-2204 (2004).

133. Drugs used in the treatment of opioid tolerance and physical dependence. K. Raith, G. Hochhaus. Int. J. Clin. Pharmacol, 42, 191-203 (2004)

11 134. In-vitro performance characteristics of valved holding chamber and spacer devices with a fluticasone metered-dose inhaler. Liang J, Coowanitwong I, Hochhaus G, Asmus MJ. Pharmacotherapy 24, 159-166 (2004).

135. Simultaneous quantification of beclomethasone dipropionate and its metabolite, beclomethasone 17- monopropionate in rat plasma and different tissues by liquid chromatography positive electrospray ionization tandem mass spectrometry. Y Wang, G. Hochhaus. J Chromatography B 805, 203-210 (2004).

136. Characterization of degradation products of mometasone furoate. S. Sahasranaman, M. Issar, G. Toth, G. Horvath, G. Hochhaus. Die Pharmazie 59, 367-373 (2004)

137. Metabolism of dynorphin A(1-13). B. Brugos, G. Hochhaus. Die Pharmazie 59, 339-343 (2004)

138. New Developments for corticosteroids. G. Hochhaus. Proc Am Thorac Soc 1, 269- 274 (2004)

139. Optimizing pharmaceutical properties of inhalation drugs. G. Hochhaus. Respiratory Drug Delivery IX, R. Dalby, P. Byron, J. Peart, J.D. Suman, S.J. Farr, eds, Davis Healthcare International Publishing, Raleigh, NC, Volume 1, 59-67 (2004)

140. Intranasal loteprednol etabonate in healthy male subjects: Pharmacokinetics and effects on endogenous cortisol. R. Hermann, M. Locher, M. Siebert-Weigel, N.La Vallee, H. Derendorf, G. Hochhaus. J. Clin. Pharmacol., 44, 510-519 (2004)

141. Age effects on the pharmacokinetics of tityustoxin from Tityus serrulatus scorpion venom in rats. E.A. Nunan, V. Arya, G. Hochhaus, V.N. Cardoso, T. Moraes-Santos. Braz. J. Med. Res, 37, 385-390 (2004)

142. Possibilities in improvement of glucocorticoid treatments in asthma with special reference to loteprednol etabonate. I. Szelenyi, R. Hermann, G. Hochhaus, A. Pahl. Die Pharmazie 59, 409-411 (2004)

143. Identification of stabilized dynorphin derivatives for suppressing tolerance in morphine dependent rats. S. I. Al-Fayoumi, B. Brugos, V. Arya, E. Mulder , B. Epple, A. Mauderli and G. Hochhaus. Pharm Res 21, 1450-1456 (2004)

144. Stabilized dynorphin derivatives for modulating antinociceptive activity in morphine tolerant rats: Effect of different routes of administration. B. Brugos, Vikram Arya, Guenther Hochhaus. AAPS J. 2004; 6, article 36(4); www.aapsj.org

145. Brain permeability of inhaled corticosteroids. V. Arya, M. Issar, Y. Wang, J. D. Talton, G. Hochhaus. JPP 57, 1159-1168 (2005)

146. Contrary to adult, neonatal rats show pronounced brain uptake of corticosteroids. V. Arya, V. DeMarco, M. Issar, G. Hochhaus. Drug Metab Dispos 34;939-42 (2006).

147. A novel method for polymer coating of plasmid DNA: Initial investigations into the use of pulsed laser deposition and gene delivery. H. Coulen, J. Hughes, J. Talton, G. Hochhaus. J. Drug Targeting 12, 237-241 (2004)

148. Evaluation of oral budesonide in the treatment of active distal ulcerative colitis: Influence of the dosing regimen on pharmacokinetics, clinical efficacy and safety . H.H. Kolkman, H.W Moellmann, A.C. Moellmann, AS Pena, R. Greinwald, H.-D. Tauschel, G. Hochhaus. Drugs of Today, 40, 589-601 (2004)

149. How the lung handles drugs pharmacokinetics and pharmacodynamics of inhaled corticosteroids. J. Winkler, G. Hochhaus, H. Derendorf. Proc Am Thorac Soc 1, 356-363 (2004)

12 150. Pharmacokinetic-pharmacodynamic evaluation of inhalation drugs: application to targeted pulmonary delivery systems using inhaled glucocorticoids as the main example. Z. Tayab, G. Hochhaus. Expert opinions on drug delivery 2, 519-532 (2005)

151. A sensitive liquid chromatography–tandem mass spectrometry method for the quantification of mometasone furoate in human plasma. S. Sahasranaman, Y. Tang, D. Biniasz, G. Hochhaus. J Chromatography B 819, 175-179 (2005)

152. Do Intensive Care Patients Need to Receive an Individualized Dosing Regimen for Levofloxacin? Z. Tayab, G. Hochhaus, S. Kaufmann, D. Jäger, J. Barth. Int. J. Clin. Pharmacol.Ther. 44: 262-9 (2006)

153. Differences in the Glucocorticoid to Progesterone Receptor Selectivity of Inhaled Glucocorticoids M. Issar, S. Sahasranaman, P. Buchwald, G. Hochhaus. Eur. Resp. J. 27, 511-516 (2006)

154. Interpretation of absorption rate data for inhaled fluticasone propionate obtained in compartmental pharmacokinetic modeling. S. Krishnaswami, G. Hochhaus, H. Moellmann, J. Barth, H. Derendorf. Int J. Clin Pharmacol. Ther. 43, 117-122 (2005)

155. Metabolism of Mometasone Furoate and Biological Activity of the Metabolites. S. Sahasranaman, M. Issar, G. Hochhaus. DMD 34: 225-233 (2006)

156. Plasma concentrations of inhaled corticosteroids in relation to airflow obstruction in asthma, K. Mortimer, T.W. Harrison, Y.T. Kai Wu, ,S. Lewis, S. Sahasranaman, G. Hochhaus, A.E. Tattersfield. Br. J. Clin. Pharmacol. 62, 412-419 (2006)

157. Budesonide in previously untreated autoimmune hepatitis. J Wiegand, A Schuler, S Kanzler, A Lohse, U Beuers, W Kreisel, U Spengler, S Koletzko, PL Jansen, G Hochhaus, HW Moellmann, M Prols, MP Manns Liver Int 25:927-934 (2005).

158. Comparative pharmacology, bioavailability, pharmacokinetics, and pharmacodynamics of inhaled glucocorticosteroids. M. Hubner, M., G. Hochhaus, , H. Derendorf, Immunol Allergy Clin North Am, 25, 469-488 (2005)

159. What is the best marker for inhaled corticosteroid safety? H. Derendorf, G. Hochhaus. Allergy Asthma Proc 26, 89-93 (2005).

160. Pharmacological effects of some newly developed soft anticholinergics and a receptor-binding QSAR study. N. Mori, P. Buchwald, W.-M. Wu, F. Ji, G. Hochhaus, N. Bodor. Pharmazie 61, 148-153 (2006)

161. Influence of the N-acetylation polymorphism on the metabolism of talampanel: an investigation in fasted and fed subjects genotyped for NAT2 variants. P. Buchwald, A. Juhasz, C. Bell, M. Patfalusi, P. Kovacs, G. Hochhaus, J. Howes, N. Bodor..Pharmazie 61, 125-34 (2006).

162. Lung bioavailability of hydrofluoroalkane fluticasone in young children when delivered by an antistatic chamber/mask. Y. Khan, Y. Tang, G. Hochhaus, J. J. Shuster, T. Spencer, S. Chesrown, L. Hendeles, J. Pediatr. 149, 793- 797 (2006)

163. Pulmonary targeting of sustained release formulation of budesonide in neonatal rats. V. Arya, I. Coowanitwong, B. Brugos, W.-S. Kim, R. Singh, G. Hochhaus. J. Drug Targeting 14, 680-686 (2006)

164. Pharmacokinetic Evaluation of Dosage Forms for Colonic Delivery. G. Hochhaus. Future Drug Delivery 1, 49-51 (2006)

13 165. Advances in single-entity inhaled corticosteroid therapy. Z. Tayab, G. Hochhaus, Allergy and Asthma Proceedings, 28, 125-135 (2007)

166. What pharmacokinetic and pharmacodynamic properties are important for inhaled glucocorticoids? G. Hochhaus. Annals of Allergy, Asthma, & Immunology 98, S7-S15 (2007)

167. Pharmacokinetic/Pharmacodynamic Profile of Mometasone Furoate Nasal Spray: Potential Effects on Clinical Safety and Efficacy. G. Hochhaus. Clin. Therapeutics 30, 98-107 (2008).

168. Laser-ablated nanofunctional polymers for the formulation of slow-release powders for dry powder inhalers: physicochemical characterization and slow-release characteristics. I. Coowanitwong, G. Patel, W-S Kim, V. Craciun, J. R. Rocca, R. R. Singh, and G. Hochhaus. J Pharmacy Pharmacol. 59, 1473-1484 (2007)

169. Plasma levels of fluticasone and budesonide following inhalation: effect of bronchoconstriction. K. Mortimer, T.W. Harrison, Y.T. K. Wu, S. Lewis, S. Sahasranaman, G. Hochhaus, A.E. Tattersfield. Br. J. Clin. Pharmacol. 64, 439-444 (2007)

170. Pharmacokinetic/pharmacodynamic evaluation of urinary cortisol suppression after inhalation of fluticasone propionate and mometasone furoate. Z.R. Tayab, T.C. Fardon, D.K.C. Lee, K. Haggart, L.C. McFarlane, B.J. Lipworth, G. Hochhaus. Br. J. 64, 698-705 (2007)

171. Pharmacokinetic/pharmacodynamic factors and steroid sensitivity. G. Hochhaus. Steroid Insensitivity. Edited by B. Adcock (in press).

172. Slow release formulations of Inhaled Rifampin. AAPS Journal (in revision)

173. Simultaneous Determination of Dexamethasone, Dexamethasone 21-Acetate. N.Govan, G. Hochhaus. J Liquid Chromatography (in press)

174. Nasal Fluticasone Furoate Monography, N. Govin, G. Hochhaus, Drugs of Today (in press)

175. Relative receptor affinity comparisons among inhaled/intranasal corticosteroids: Perspectives on scientific pursuit and clinical relevance. G. Hochhaus, J Respir. Research (submitted)

14 ABSTRACTS PRESENTED AT MEETINGS

1. Identification of glucocorticoid receptors in normal and neoplastic human lung. G. Hochhaus, H. Möllmann, P. Rohdewald. Tagung der Gesellschaft fuer Lungen- und Atemwegforschung, Bochum (1982)

2. Affinity of glucocorticoids to their receptors in adult human lung. G. Hochhaus, H. Möllmann, P. Rohdewald. 35th meeting of the Academy of Pharmaceutical Sciences, Miami (1983)

3. Binding affinities of commercial glucocorticoids to the glucocorticoid receptor of the adult human lung. G. Hochhaus, P. Rohdewald, H. Möllmann, K.M. Mueller. 1. Gesamtkongress der pharmazeutischen Wissenschaften, Muenchen (1983)

4. Rezeptoraffinitäten handelsüblicher Glukokortikoide zum Glukokortikoid-Rezeptor der menschlichen Lunge. G. Hochhaus, P. Rohdewald, H. Möllmann G. Greschuchna, J. Barth, E.W. Schmidt. 31. Kongreß der Deutschen Gesellschaft für Pneumologie und Tuberkulose, Essen (1984)

5. Pharmakokinetische Wechselbeziehung intravenös applizierter Glukokortikoide in Serum und Lunge. J. Barth, H. Möllmann, E.W. Schmidt, P. Rohdewald, J. Rehder, G. Hochhaus. 31. Kongreß der Deutschen Gesellschaft für Pneumologie und Tuberkulose, Essen (1984)

6. Characterization of mu and delta opioid binding sites in a human neuroblastoma cell line. V. C Yu, M.L. Richards, G. Hochhaus, W. Sadee. International Narcotic Research Conference, North Falmouth, Massachusetts (1985)

7. Biotinylated ßh-endorphin derivatives as markers of the opiate receptors. G. Hochhaus, B.W. Gibson, W. Sadee. International Narcotics Research Conference, San Francisco, CA (1986)

8. Dynamics of receptor and second messenger regulation in human neuroblastoma cells. W. Sadee, V. C. Yu, G. Hochhaus. American Association of Pharmaceutical Scientists Annual Meeting, Washington D.C. (1986)

9. Second messengers of opioid and muscarinic receptors in human neuroblastoma cells. V.C. Yu, G. Hochhaus, W. Sadee. American Association of Pharmaceutical Scientists Annual Meeting, Washington, D.C. (1986)

10. Biotin labeled ßh-endorphin analogs as probes for the opiate receptor. G. Hochhaus, B.W. Gibson, W. Sadee. American Association of Pharmaceutical Scientists Annual Meeting, Washington D.C. (1986)

11. An avidin-biotin based enzyme-immunoassay for ß-endorphin. G. Hochhaus, W. Sadee. American Association of Pharmaceutical Scientists Western Regional Meeting, Reno, NV (1988)

12. [Biocytin13]dynorphin A1-13 amide: a potential probe for the kappa opioid receptor. G. Hochhaus, A. Patthy, R. Schwietert, D.V. Santi, W. Sadee. American Association of Pharmaceutical Scientists Annual Meeting, Orlando, FL (1988)

13. Pharmacodynamic and mechanic interactions of locally administered glucocorticoid crystal suspensions. H. W. Möllmann, H. Derendorf, G. Hochhaus, J. Barth. 4th Annual Meeting of the German Society for Osteology, Göttingen (1989)

14. Pharmacodynamic interactions of systemic glucocorticoid therapy. J. Barth, H.W. Möllmann, H. Derendorf, G. Hochhaus. 4th Annual Meeting of the German Society for Osteology, Göttingen (1989)

15. Pharmacokinetic aspects of intra-articular administration of glucocorticoids. H. Derendorf, H.W. Möllmann, P. Rohdewald, D. Strohband, J. Barth, G. Hochhaus, 4th Annual Meeting of the German Society for Osteology, Göttingen (1989)

15 16. Biopharmaceutical and pharmacological aspects of locally and systemically administered glucocorticoids. H. W. Möllmann, H. Derendorf, G. Hochhaus, J. Barth, 4th Annual Meeting of the German Society for Osteology, Göttingen (1989)

17. Comparison of the clinical pharmacodynamics of dexamethasone, methylprednisolone and triamcinolone acetonide. G. Hochhaus, H. Derendorf, H.W. Möllmann, C. Möllmann, M. Krieg, S. Tunn, J. Barth, H. J. Röthig. IV World Conference on Clinical Pharmacology and Therapeutics, Mannheim-Heidelberg (1989)

18. Time course of bronchospasmolytic effects after injection of different water-soluble glucocorticoids. H.W. Möllmann, J. Barth, H. Derendorf, G. Hochhaus. IV World Conference on Clinical Pharmacology and Therapeutics, Mannheim-Heidelberg (1989)

19. Transfer of different water-soluble glucocorticoids through the alveolar membrane. J. Barth, G. Hochhaus, H.W. Möllmann, P. Rohdewald. IV World Conference on Clinical Pharmacology and Therapeutics, Mannheim-Heidelberg (1989)

20. A sensitive enzyme-linked immunoassay for dynorphin A1-13. G. Hochhaus, L. Hu. American Association of Pharmaceutical Scientists Annual Meeting, Atlanta, Georgia (1989)

21. Pharmacodynamic profiles of fenoterol after different routes of administration. G. Hochhaus, E.W. Schmidt, H. Möllmann, W.T. Ulmer. American Association of Pharmaceutical Scientists Annual Meeting, Atlanta, Georgia (1989)

22. Bronchospasmolytic activity of methylprednisolone in patients with severe pulmonary obstruction. H. Möllmann, J. Barth, E.W. Schmidt, P. Rohdewald, H. Derendorf, G. Hochhaus. American Association of Pharmaceutical Scientists Annual Meeting, Atlanta, Georgia (1989)

23. Techniques for small peptides analysis: studies of pentigetide by capillary electrophoresis and immunoassay. S.-L. Chiang, K. Sasaki, T. Lobl, E. Morgan, S. Taylor, G. Hochhaus, J.L. Noone, T. Stolzer, M. Smith, J.C. Colburn. Eleventh American Peptide Symposium. San Diego CA (1989)

24. Pharmacokinetic and pharmacodynamic optimization of systemic glucocorticoid therapy in colitis. J. Barth, H.W. Möllmann, H. Derendorf, G. Hochhaus. Ulmer Symposium on Colitis, Ulm (1990)

25. Free peripheral compartment levels as interface between pharmacokinetics and pharmacodynamics of glucocorticoids. H. Derendorf, H. Möllmann, G. Hochhaus. 3rd Frontiers of Pharmacokinetics and Pharmacodynamics Symposium, Baltimore, Maryland (1990)

26. Pharmacokinetic-pharmacodynamic modeling of beta-adrenergic effects of fenoterol. G. Hochhaus, E.W. Schmidt, K.L. Rominger, H. Möllmann. 3rd Frontiers of Pharmacokinetics and Pharmacodynamics Symposium, Baltimore, Maryland (1990)

27. Clinical pharmacology of rectally administered glucocorticoids for Crohn's disease and colitis ulcerosa. H. Möllmann, J. Barth, D. Hüppe, H. Derendorf, G. Hochhaus. Ulmer Symposium on Colitis, Ulm (1990)

28. Clinical pharmacology of pharmacokinetics, intrinsic activity and biopharmaceu-tical properties of glucocorticoids after oral and intravenous administration. H. Möllmann, J. Barth, H. Derendorf, G. Hochhaus. Ulmer Symposium on Colitis, Ulm (1990)

29. Pharmacokinetic-pharmacodynamic modeling of beta-adrenergic effects of fenoterol after different routes of administration. G. Hochhaus. 23rd Annual Higuchi Research Seminar, Lake Ozark (1990)

30. An integrated pharmacokinetic-pharmacodynamic model for fenoterol. G. Hochhaus, E.W. Schmidt, K.L. Rominger, H. Möllmann. International Symposium on Measurement and Kinetics of in-vivo drug effect. Noordwijk (1990)

16

31. Glucocorticoid therapy for Crohn's disease and colitis ulcerosa. H. Möllmann, J. Barth, H. Derendorf, G. Hochhaus. Ulmer Symposium on Colitis, Ulm (1990)

32. Prediction of clinical potency of corticosteroids by pharmacokinetic-pharmacodynamic modeling. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth. Fifth Annual Meeting and Exposition of the American College of Clinical Pharmacology (ACCP), Las Vegas (1990). J. Clin. Pharmacol. 30, 835 (1990)

33. Area under the effect-time-curve as measure of cumulative drug effects. H. Derendorf. G. Hochhaus, H. Möllmann, J. Barth. American Association of Pharmaceutical Scientists. Annual Meeting, Las Vegas, Nevada (1990). Pharm. Res. 7, S-216 (1990)

34. Loteprenol etabonate: tissue distribution and receptor binding. G. Hochhaus, L.S. Chen, H. Derendorf, P. Druzgala, A. Ratka, American Association of Pharmaceutical Scientists. Annual Meeting, Las Vegas, Nevada (1990). Pharm. Res. 7, S-227 (1990)

35. Stability, opioid receptor binding and in-vivo evaluation of novel, brain specific redox carrier peptide systems. E. Brunt, G. Hochhaus, J. Sastry. American Association of Pharmaceutical Scientists. Annual Meeting, Las Vegas, Nevada (1990). Pharm. Res. 7, S-65 (1990)

36. Pharmacokinetics and pharmacodynamics of fenoterol. G. Hochhaus, E.W. Schmidt, K.L. Rominger, H. Möllmann. Fifth Annual Meeting and Exposition of the American College of Clinical Pharmacology (ACCP), Las Vegas (1990). J. Clin. Pharmacol. 30, 848 (1990)

37. A new class of anti-inflammatory glucocorticoids: soft analogs with 17 alkoxy side chains. P. Druzgala, G. Hochhaus, N. Bodor. Am. Chem. Society, Boston (1990)

38. Soft glucocorticoids: 17 -ether substitution and receptor binding. G. Hochhaus, R. Hochhaus, P. Druzgala, M-J. Huang, N. Bodor. American Association of Pharmaceutical Scientists. Southeast Region Meeting, Charleston (1991)

39. A sensitive assay for the simultaneous measurement of dexamethasone and dexamethasone-21-isonicotinate. G. Hochhaus, R. Hochhaus, H. Möllmann, C. Barmeyer, H. Derendorf. American Association of Pharmaceutical Scientists. Southeast Region Meeting, Charleston (1991)

40. Prediction of clinical potency of corticosteroids by pharmacokinetic pharmacodynamic modeling. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth. American Association of Pharmaceutical Scientists. Southeast Region Meeting, Charleston (1991)

41. Area under the effect-time curve as measure of cumulative drug effects. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth. American Association of Pharmaceutical Scientists. Southeast Region Meeting, Charleston (1991)

42. Dose optimization of corticosteroids. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth. The Southeastern Chapter of the American College of Clinical Pharmacology, Johnson City, TN (1990)

43. Systemic absorption of prednicarbate after dermal, oral and pulmonary administration. J. Barth, H.W. Möllmann, H. Derendorf, C. Möllmann, G. Hochhaus, K.H. Lehr, Th. Höler. XIth International Congress of Pharmacology. Amsterdam, The Netherlands (1990)

44. The nose as localization where bronchodilators act. E.W. Schmidt, G. Hochhaus, K.L. Rominger, H. Möllmann, W.T. Ulmer. 9th Congress of the European Society of Pneumology, London (1990)

17 45. Biopharmaceutical characterization of crystals in glucocorticoid suspension, J. Barth, H. Möllmann, J. Armbruster, O.W. Flörke, G. Hochhaus, H. Derendorf. Fifth Annual Meeting of the American Association of Pharmaceutical Scientists, Las Vegas (1990)

46. Differences in the profile of action and in the pharmacokinetics of fenoterol after nasal application and inhalation. E.W. Schmidt, G. Hochhaus, K.L. Rominger, H. Möllmann, W.T. Ulmer. Pneumologie 44,1038 (1990)

47. Clinical relevance of pharmacokinetic/dynamic and biopharmaceutical properties of glucocorticoids after oral, intravenous and rectal administration. H.W. Möllmann, J. Barth, H. Derendorf, G. Hochhaus, Glucocorticoids for the disease specific therapy of chronic inflammatory disorders, Cologne, Germany (1991)

48. Dose optimization using integrated pharmacokinetic/dynamic models. H. Derendorf, H.W. Möllmann, J. Barth, G. Hochhaus, Glucocorticoids for the disease specific therapy of chronic inflammatory disorders, Cologne, Germany (1991)

49. Pharmacodynamic interactions of glucocorticoids with inflammatory and immunological processes. J. Barth, H.W. Möllmann, H. Derendorf, G. Hochhaus, Glucocorticoids for the disease specific therapy of chronic inflammatory disorders, Cologne, Germany (1991)

50. Pharmacokinetics/pharmacodynamic model for fenoterol after different routes of administration E.W. Schmidt, G. Hochhaus, K.L. Rominger, H. Möllmann, W.T. Ulmer, Klin. Wochenschr. 69 (Suppl. XXIII), 166 (1991)

51. An integrated pharmacokinetic/pharmacodynamic model for beta2-adrenergic bronchodilators. E.W. Schmidt, G. Hochhaus, K.L. Rominger, H. Möllmann, W.T. Ulmer. 1st Annual Congress of the European Respiratory Society. Brüssel (1991)

52. Ultra-high doses of methylprednisolone in acute spinal cord injury: pharmacokinetic considerations. H. Möllmann, J. Barth, U. Bötel, G. Hochhaus, H. Derendorf, T. Wagner, 20th Annual Meeting of the American College of Clinical Pharmacology Atlanta (1991)

53. Effects versus side-effects : dose optimization based on an integrated pharmaco-kinetic/dynamic approach. G. Hochhaus, H. Derendorf, E.W. Schmidt, H. Möllmann, 20th Annual Meeting of the American College of Clinical Pharmacology, Atlanta (1991)

54. Receptor based pharmacokinetic-pharmacodynamic model for corticosteroids. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth. American Society for Clinical Pharmacology and Therapeutics, Orlando (1991)

55. Pharmacodynamic profiles of fenoterol after different routes of administration. E.W. Schmidt, G. Hochhaus, K.L. Rominger, H. Möllmann, W.T. Ulmer. American College of Chest Physicians, 57th Annual Scientific Assembly, San Francisco (1991)

56. A sensitive assay for the simultaneous measurement of dexamethasone and dexamethasone-21-isonicotinate. G. Hochhaus, R. Hochhaus, H. Möllmann, C. Barmeyer, H. Derendorf. American Association of Pharmaceutical Scientists, Washington DC (1991), Pharm. Res. 8, S-44 (1991)

57. New fluorescence assay of tyrosine containing peptides. M. Tellier, G. Hochhaus, R.J. Prankerd. American Association of Pharmaceutical Scientists, Washington DC (1991), Pharm. Res. 8, S-24 (1991)

58. Glucocorticoid receptor binding affinity of novel soft steroids. E. Brunt, G. Hochhaus, N. Bodor. American Association of Pharmaceutical Scientists, Washington DC (1991), Pharm. Res. 8, S-80 (1991)

18 59. Soft glucocorticoids: 17 -ether substitution and receptor binding. G. Hochhaus, P. Druzgala, M.-J. Huang, N. Bodor. American Association of Pharmaceutical Scientists, Washington DC (1991), Pharm. Res. 8, S- 245 (1991)

60. Is there a dose with an optimal effect/side effect ratio? G. Hochhaus, H. Derendorf, H. Möllmann, E. Schmidt. American Association of Pharmaceutical Scientists, Washington DC (1991), Pharm. Res. 8, S-316 (1991)

61. Systemic absorption from hydrocortisone acetate rectal foam after single and multiple administration in healthy volunteers and patients with ulcerative colitis. J. Barth, H. Möllmann, S. Tunn, T. Wagner, H. Derendorf, G. Hochhaus. 11th Congress of the European Association of Infernal Medicine, Lisbon (1991)

62. Comparative pharmacokinetics and pharmacodynamics of intravenously administered prodrugs for corticosteroids. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth. Japanese-U.S. Symposium on Drug Delivery, Maui (1991)

63. Glucocorticoid suspensions for sustained release delivery in orthopedics and rheumatology: factors modulating bioavailability. J. Barth, H. Möllmann, H. Derendorf, G. Hochhaus. Japanese-U.S. Symposium on Drug Delivery, Maui (1991)

64. Morphological properties, pharmacokinetics and local availability of intraarticularly administered glucocorticoid crystal suspension. J. Barth, H. Möllmann, H. Derendorf, G. Hochhaus. 98th Conference of the German Society of Internal Medicine, Wiesbaden (1992)

65. Bioactivity of a generic pancreatic enzyme in cystic fibrosis. L. Hendeles, J. Pedersen, E. Bowser, A. Stecenko, L. Monlino, P. Toskes, H. Sitren, R. Cooper, G. Hochhaus, S. Kazerounian. ACCP, Orlando (1992)

66. Receptor based pharmacokinetic-pharmacodynamic model for corticosteroids. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth. Ninety-third Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Orlando (1991)

67. Comparative pharmacokinetics and pharmacodynamics on intravenously administered prodrugs for corticosteroids. H. Derendorf, G. Hochhaus, H. Möllmann. 1992 Southeast Regional Meeting of the American Association of Pharmaceutical Scientist, Wilmington (1992)

68. A sensitive assay for the simultaneous measurement of dexamethasone and dexamethasone-21- sulfobenzoate. G. Hochhaus, H. Derendorf, H. Möllmann, J. Barth, 1992 Southeast Regional Meeting of the American Association of Pharmaceutical Scientist, Wilmington (1992)

69. Receptor-binding affinities of novel soft steroids. G. Hochhaus, N. Bodor, E. Brunt. Southeast Regional Meeting of the American Association of Pharmaceutical Scientist, Wilmington (1992)

70. Is there a dose with an optimal effect/side effect ratio. G. Hochhaus, H. Derendorf, H. Möllmann. Southeast Regional Meeting of the American Association of Pharmaceutical Scientist, Wilmington (1992)

71. Clinical potencies of beta-2-agonists as assessed by a PK/PD approach. G. Hochhaus, L. Hendeles, L. Harmon, H. Möllmann. Southeast Regional Meeting of the American Association of Pharmaceutical Scientist, Wilmington (1992)

72. Bioactivity of a generic pancreatic enzyme in cystic fibrosis. L. Hendeles, J. Pedersen, E. Bowser, A. Stecenko, L. Molino, P. Toskes, H. Sitren, R. Cooper, G. Hochhaus. 13th Annual Meeting ACCP, Toronto, Canada (1992)

19 73. Suppression of the hypopituitary adrenal axis by a topical glucocorticoid of the non-fluorinated double ester type? G. Hochhaus. World Congress of Dermatology, Dermatology Symposium, Tarrytown (1992)

74. Molecular pharmacology of glucocorticoids. First Interdisciplinary Forum on Therapy Concepts for Glucocorticoids. G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf. Darmstadt, Germany (1992)

75. Dose optimization for the therapy of glucocorticoids. First Interdisciplinary Forum on Therapy Concepts for Glucocorticoids. H. Derendorf, H. Möllmann, J. Barth, G. Hochhaus, Darmstadt, Germany (1992)

76. Pharmacodynamic interactions of glucocorticoids with inflammatory and immunological processes. J. Barth, H. Möllmann, G. Hochhaus, H. Derendorf. First Interdisciplinary Forum on Therapy Concepts for Glucocorticoids, Darmstadt, Germany (1992)

77. Pharmacokinetic/dynamic investigations of ultra-high doses of methylprednisolone in patients with acute spinal injury. H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf, E. v. Winden, U. Bötel. First Interdisciplinary Forum on Therapy Concepts for Glucocorticoids, Darmstadt, Germany (1992)

78. Bioactivity of a generic equivalent to pancrease MT16. L. Hendeles, E. Bowser, A. Stecenko, L. Molino, P. Toskes, R. Cooper, G. Hochhaus, S. Kazerounian. Pediatric Pulmonology, Suppl. 8, 311 (1992)

79. Pharmacokinetics and pharmacodynamics of prednisolone after intravenous and oral administration. H. Möllmann, M. Damoiseaux, J. Barth, K.-H. Brandis, G. Hochhaus, H. Derendorf. J. Clin. Pharmacol. 32, 750 (1992)

80. Clinical activities of selected beta-2-adrenergic drugs: A PK/PD based comparative approach. G. Hochhaus. L. Hendeles, H. Möllmann. J. Clin. Pharmacol. 32, 752 (1992)

81. Evaluation of pharmacokinetic interactions between prednisolone and hydrocortisone. S. Rohatagi, H. Möllmann, J. Barth. J. Clin. Pharmacol. 32, 756 (1992)

82. Use of ultra-high doses of methylprednisolone in acute spinal cord injury-steroid pharmacokinetics in plasma and cerebrospinal fluid, influence on adrenal cortisol and on some relevant blood parameters. J. Barth, G. Hochhaus, H.W. Möllmann, F. Schumann, U. Bötel, E. v. Winden, H. Derendorf. 6th European Congress on Intensive Care Medicine. Barcelona, Spain (1992)

83. Analysis of hydrocortisone, prednisolone and methylprednisolone in biological fluids using normal phase chromatography S. Rohatagi, H. Möllmann, J. Barth, A. Soldner, G. Hochhaus, H. Derendorf 1993 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Research Triangle Park (1993)

84. In-vitro plasma degradation ofdynorphin A1-13. S. Müller, L. Prokai, G. Hochhaus. 1993 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Research Triangle Park (1993)

85. Leucine enkephalin-tyrosinase reaction products-Identification and biological activity. V. Larsimont, L. Prokai, G. Hochhaus. 1993 Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Research Triangle Park (1993)

86. Pharmacokinetics and pharmacodynamics of budesonide after rectal application. H. Möllmann, A. Tromm, U. ScH.W.egler, B. May, J. Barth, T. Wagner, H. Derendorf, G. Hochhaus. 9th Annual Meeting of the American Gastroenterological Association, Boston (1993)

87. Pharmacokinetics and pharmacodynamics of budesonide after oral topical administration. A. Tromm, H. Möllmann, U. Schwegler, B. May, J. Barth, H. Derendorf, G. Hochhaus. 9th Annual Meeting of the American Gastroenterological Association, Boston (1993)

20 88. Comparison of pharmacodynamic effects of 3 mg budesonide in healthy volunteers and patients with inflammatory bowel disease after ileostomy. H.W. Ecker, H. Möllmann, A. Tromm, W. Lindemann, J. Barth, H. Derendorf, G. Hochhaus, B. May. IV. International Symposium on Chronic Inflammatory Bowel Diseases, Strassburg (1993)

89. Mode of action of receptor mediated glucocorticoid action. G. Hochhaus IV. International Symposium on Chronic Inflammatory Bowel Diseases, Strassburg (1993)

90. Pharmacodynamics of budesonide after rectal application in healthy volunteers: evidence for low systemic side effects. H. Möllmann, A. Tromm, U. Schwengler, B. May, J. Barth, A. Wagner, S. Tunn, M. Krieg, H. Derendorf, G. Hochhaus. IV. International Symposium on Chronic Inflammatory Bowel Diseases, Strassburg (1993)

91. Plasma levels of budesonide after multiple oral administration of budesonide in healthy volunteers. H. Möllmann, A. Tromm, J. Barth, S. Tunn, M. Krieg, U. Schwengler, B. May, H. Derendorf, G. Hochhaus. IV. International Symposium on Chronic Inflammatory Bowel Diseases, Strassburg (1993)

92. Systemic effects of orally administered budesonide: comparison of a single and divided dose regimen. J. Barth, H. Möllmann, A. Tromm, S. Tunn, M. Krieg, U. Schwengler, B. May, H. Derendorf, G. Hochhaus. IV. International Symposium on Chronic Inflammatory Bowel Diseases, Strassburg (1993)

93. Pharmacokinetics and metabolic interactions of ultra-high dosed methylprednisolone in patients with acute spinal cord injury. U. Bötel, E. Gläser, J. Barth, R. Schumann, G. Hochhaus, H. Derendorf, S. Tunn, M. Krieg, C. Möllmann, H. Möllmann. 3rd Scientific Meeting of the Scandinavian Medical Society of Paraplegia, Lahti (1993)

94. Clinical significance of pharmacokinetic-pharmacodynamic modeling of corticosteroids. H. Derendorf, G. Hochhaus, H. Möllmann, J. Barth. World Congress of Pharmacy and Pharmaceutical Sciences FIP 1993, Tokyo (1993)

95. Oral treatment with budesonide in healthy volunteers: evidence of low systemic side effects. A. Tromm, H. Möllmann, U. ScH.W.engler, B. May, J. Barth, H. Derendorf, G. Hochhaus. 22nd Annual Meeting of the American College of Clinical Pharmacology, Boston (1993)

96. Pharmacodynamics of budesonide after rectal application in healthy volunteers. H. Möllmann, A. Tromm, U. Schwengler, B. May, J. Barth, T. Wagner, H. Derendorf, G. Hochhaus. 22nd Annual Meeting of the American College of Clinical Pharmacology, Boston (1993)

97. New electrochemical and fluorogenic assays for leucine enkephalin based on enzymatic derivatization by tyrosinase. V. Larsimont, M. Bogaards, P. Mulleneers, G. Hochhaus. AAPS Eighth Annual Meeting, Orlando, Florida (1993). Pharm. Res. 10, S62 (1993)

98. In-vitro plasma degradation of dynorphin A1-13. S. Müller, L. Prokai, G. Hochhaus. AAPS Eighth Annual Meeting, Orlando, Florida (1993). Pharm. Res. 10, S92 (1993)

99. Pharmacokinetic and pharmacodynamic modeling of multiple dosing regimens of methylprednisolone and prednisolone. S. Rohatagi, H. Möllmann, J. Barth. A. Soldner, G. Hochhaus. AAPS Eighth Annual Meeting, Orlando, Florida (1993). Pharm. Res. 10, S384 (1993)

100. Oral treatment with budesonide: results of a pharmacodynamic study in health volunteers. A. Tromm., H. Möllmann, U. Schwengler, B. May, J. Barth, H. Derendorf, G. Hochhaus. AAPS Eighth Annual Meeting, Orlando, Florida (1993). Pharm. Res. 10, S385 (1993)

101. PK/PD based comparison of beta-2-adrenergic drugs. G. Hochhaus, L. Hendeles, H. Möllmann. AAPS Eighth Annual Meeting, Orlando, Florida (1993). Pharm. Res. 10, S385 (1993)

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102. Leucine enkephalin tyrosinase reaction products-identification and biological activity. V. Larsimont, L. Prokai, G. Hochhaus. AAPS Eighth Annual Meeting, Orlando, Florida (1993). Pharm. Res. 10, S386 (1993)

103. Budesonide enemas and suppositories in healthy volunteers: evidence for low systemic side effects. H. Möllmann, A. Tromm, U. Schwegler, B. May, J. Barth, Th. Wagner, H. Derendorf, G. Hochhaus. AAPS Eighth Annual Meeting, Orlando, Florida (1993). Pharm. Res. 10, S387 (1993)

104. Pharmacokinetics of prednicarbate in humans after oral, pulmonary and cutaneous administration. J. Barth, G. Hochhaus, H. Derendorf, K. Lehr, T. Hoehler, H. Möllmann. AAPS Eighth Annual Meeting, Orlando, Florida (1993). Pharm. Res. 10, S389 (1993)

105. Receptor-based PK/PD model for corticosteroids. H. Derendorf, G. Hochhaus, S. Rohatagi, J. Barth, H. Möllmann. Second European Congress of Pharmaceutical Sciences, Berlin (1994). Eur. J. Pharm. Sci. 2, 92 (1994)

106. PK/PD characterization of pulmonary targeting. G. Hochhaus, R. Gonzalez-Rothi, E.W. Schmidt, H. Möllmann, H. Derendorf, T. Dalla Costa, H. Schreier. Second European Congress of Pharmaceutical Sciences, Berlin (1994). Eur. J. Pharm. Sci. 2, 102 (1994)

107. Pharmacokinetic and pharmacodynamic modeling of oral multiple dosing of methylprednisolone. S. Rohatagi, A. Soldner, J. Barth, H. Möllmann, G. Hochhaus, H. Derendorf. 23rd Annual Meeting of the American College of Clinical Pharmacology, Orlando (1994)

108. A novel method for analysis of budesonide and its metabolites in biological fluids. P. Froehlich, H. Derendorf, H. Möllmann, G. Hochhaus. 23rd Annual Meeting of the American College of Clinical Pharmacology, Orlando (1994)

109. Pharmacokinetic and pharmacodynamic modeling of oral multiple dosing of methylprednisolone. S. Rohatagi, A. Soldner, J. Barth, H. Möllmann, G. Hochhaus, H. Derendorf. 9th Annual Meeting of the American Association of Pharmaceutical Scientists, San Diego (1994). Pharm. Res. 11, S369 (1994)

110. Kinetic Evaluation of dynorphin A1-13 metabolism in human plasma in vitro. S. Müller, G. Hochhaus. 9th Annual Meeting of the American Association of Pharmaceutical Scientists, San Diego (1994). Pharm. Res. 11, S369 (1994)

111. Influence of endogenous hydrocortisone on pharmacokinetics and pharmacodynamics of exogenous corticosteroids. S. Rohatagi, E. Galia, G. Hochhaus, H. Derendorf. 9th Annual Meeting of the American Association of Pharmaceutical Scientists, San Diego (1994). Pharm. Res. 11, S369 (1994)

112. Pharmacokinetic and pharmacodynamic modeling of triamcinolone acetonide after intravenous, oral and pulmonary administration. S. Rohatagi, E. Galia, G. Hochhaus, H. Derendorf. 9th Annual Meeting of the American Association of Pharmaceutical Scientists, San Diego (1994). Pharm. Res. 11, S386 (1994)

113. Kinetic evaluation of the N-terminal metabolism of dynorphin A1-13 fragments in human plasma. S. Müller, G. Hochhaus. 9th Annual Meeting of the American Association of Pharmaceutical Scientists, San Diego (1994). Pharm. Res. 11, S410 (1994)

114. Clinical efficacy of beta-2-adrenergic drugs, A PK/PD approach. G. Hochhaus, L. Hendeles, E.W. Schmidt, H. Möllmann. Second European Congress of Pharmaceutical Sciences, Berlin (1994). Eur. J. Pharm. Sci. 2, 108 (1994)

115. A selective HPLC/RIA for budesonide in biological fluids. G. Hochhaus, P. Froelich, H. Derendorf, H. Möllmann, Second European Congress of Pharmaceutical Sciences, Berlin (1994). Eur. J. Pharm. Sci. 2, 153 (1994)

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116. New electrochemical and fluorogenic assays for leucine enkephalin based on enzymatic derivatization by tyrosinase. V. Larsimont, M. Bogaards, P. Mulleneers, G. Hochhaus. Second European Congress of Pharmaceutical Sciences, Berlin (1994). Eur. J. Pharm. Sci. 2, 156 (1994)

117. Metabolism of Dyn A1-13 in human plasma. G. Hochhaus, S. Müller. Second European Congress of Pharmaceutical Sciences, Berlin (1994). Eur. J. Pharm. Sci. 2, 175 (1994)

118. PK/PD based assessment of pulmonary effects and systemic side effects after inhalation. G. Hochhaus. Southeastern Annual Meeting of the American Association of Pharmaceutical Scientists, Research Triangle Park (1995)

119. Pharmacokinetic aspects of liposomes. G. Hochhaus (invited speaker). Fourth International Liposome Meeting, Freiburg (1995)

120. Absorption from hydrocortisone after single and multiple rectal administrations of a hydrocortisone acetate foam preparation. H. Möllmann, J. Barth, M. Krieg, T. Wagner, H. Derendorf, and G. Hochhaus. Annual Meeting of AGAH, Neuss, (1995)

121. Pharmacokinetics and metabolism of prednicarbate after different routes of administration. J. Barth, H. Möllmann, H. Derendorf, C. Möllmann, G. Hochhaus, K. Lehr, and Th. Hohler. Annual Meeting of AGAH, Neuss, (1995)

122. Plasma levels and systemic effects after administration of budesonde enemas and foams. A. Möllmann, H. Möllmann, A. Tromm, G. Hochhaus, J. Barth, C. Bigalke, H. Derendorf, and B. May. Annual Meeting of AGAH, Neuss, (1995)

123. Glukokortikoid-Kristallsuspensionen fur die intraartikulare Applikation: Kristallmorphologie, Pharmacokinetik und lokale Wirkstoffkonzentration. J. Barth, H. Möllmann, H. Derendorf, and G. Hochhaus. Annual Meeting of AGAH, Neuss, (1995)

124. Pulmonary targeting: is it really possible? G. Hochhaus, 28th Annual Higuchi Research Seminar, (1995)

125. Pharmacokinetic/dynamic model for budesonide after oral delivery of ph modified release capsules (Budenofalk). G. Hochhaus, H. Möllmann, A. Tromm, J. Barth, A. Möllmann, M. Krieg. J. of Gastroenterology and Hepatology, Abstracts First International Conference of Gastroenterolgoy Hong Kong/Shanghai, (1995)

126. Pharmacokinetic and pharmacodynamics of budesonide after oral application of budenofalk modified- release capsules in ileostoma patients. H. Möllmann, A. Tromm, J. Barth, C. Bigalke, A. Möllmann, K. Ecker, S. Lindemann, A. Ewe, H. Derendorf, G. Hochhaus. J. of Gastroenterology and Hepatology, Abstracts First International Conference of Gastroenterolgoy Hong Kong/Shanghai, (1995)

127. Pharmacokinetics of budesonide after oral delivery of pH modified release capsules (budenofalk) in healthy volunteers and patients with Crohn‟s disease and ileostoma. H. Möllmann, G. Hochhaus, A. Tromm, H. Derendorf, A. Möllmann, J. Barth, K. Ecker, A. Lindemann. J. of Gastroenterology and Hepatology, Abstracts First International Conference of Gastroenterolgoy Hong Kong/Shanghai, (1995)

128. Systemic absorption from hydrocortisone acetate rectal foam after single and multiple administration in healthy subjects and patients with distal ulcerative colitis. J. Barth, H. Möllmann, A. Tromm, C. Bigalke, H. Derendorf, G. Hochhaus. J. of Gastroenterology and Hepatology, Abstracts Thirst International Conference of Gastroenterolgoy Hong King/Shanghai, (1995)

23 129. Liposomes as a targeted drug delivery system to the lungs. R. Gonzalez-Rothi, S. Suarez, A. Lukyanov, H. Derendorf, H. Schreier, T. Dalla Costa and G. Hochhaus. 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami (1995), Pharm. Res. 12 Suppl. 314 (1995)

130. PK/PD based assessment of pulmonary effects and systemic side effects after inhalation. G. Hochhaus. 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami (1995), Pharm. Res. 12 Suppl. 314 (1995)

131. Optimizing dosing time of systemic corticosteroid administration using PK/PD modeling. S. Rohatagi, G. Hochhaus, and H. Derendorf. 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami (1995), Pharm. Res. 12 Suppl. 367 (1995)

132. Receptor based integrated pharmacokinetic and pharmacodynamic modeling of corticosteroids after single and multiple administration. S. Rohatagi, H. Möllmann, J. Barth, G. Hochhaus, and H. Derendorf. 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami (1995), Pharm. Res. 12 Suppl. 370 (1995)

133. Pharmacokinetics and pharmacodynamics of cloprednol. S. Rohatagi, H. Möllmann, J. Barth, G. Hochhaus and H. Derendorf, #PDDM8335, Pharm. Res. 12 Suppl. 410 (1995)

134. Pharmacokinetic and pharmacodynamic modeling of budesonide after single and multiple oral administration. P. Fröehlich, H. Möllmann, H. Derendorf and G. Hochhaus. 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami (1995), Pharm. Res. 12(9) Suppl. 413 (1995)

135. Displacement of 3H-L-glutamate in rat brain membranes by metabolic dynorphin fragments. S. Müller, S. Al-Fayoumi, F. Chang-sing-Pang and G. Hochhaus. 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami (1995), Pharm. Res. 12(9) Suppl. 349 (1995)

136. Plasma levels and pharmacodynamic effects of budesonide tablets and pH-modified-release capsules. Results of a comparative study in healthy volunteers. A. Tromm, H. Möllmann, J. Barth, G. Hochhaus, and H. Derendorf, Annual Meeting of AGAH, Neuss, (1995)

137. Pharmakokinetic/-dynamik - vergleich der wasserloeslichen dexamethasonester dexamethason-21- sulfobenzoate und dexamethasonphosphat. J. Barth, G. Hochhaus, R. Hochhaus, H. Derendorf and H. Möllmann. Annual Meeting of AGAH, Neuss, (1995)

138. Correlation of in vitro and in-vivo corticosteroid receptor affinity. S. Rohatagi, G. Hochhaus, H. Derendorf. Eastern Regional Meeting of the American Association of Pharmaceutical Scientists, New Brunswick, (1995)

139. Liposomes as a targeted delivery system to the lung. S. Suarez, G. Hochhaus, R. Gonzalez-Rothi, A. Lukyanov, H. Derendorf, H. Schreier, T. Dalla Costa.GRASP Meeting, New York, (1995)

140. Liposomes as a targeted drug delivery system to the lungs. R. Gonzalez-Rothi, S. Suarez, A. Lukyanov, H. Derendorf, H. Schreier, T. Dalla Costa, G. Hochhaus.Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Morrisville, (1995)

141. Optimizing dosing time of systemic corticosteroid administration using PK/PD modeling. S. Rohatagi, G. Hochhaus, H. Derendorf. Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Morrisville, (1995)

142. Receptor based integrated pharmacokinetic modeling of corticosteroids. S. Rohatagi, H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf. Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Morrisville, (1995)

24 143. Pharmacokinetics and pharmacodynamics of cloprednol. S. Rohatagi, H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf. Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Morrisville, (1995)

144. Liposomes as a targeted drug delivery system to the lungs. R. Gonzalez-Rothi, S. Suarez, A. Lukyanov, H. Derendorf, H. Schreier, T. Dalla Costa, G. Hochhaus. 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, (1995)

145. Optimizing dosing time of systemic corticosteroid administration using PK/PD modeling. S. Rohatagi, G. Hochhaus, H. Derendorf. 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, (1995)

146. Receptor based integrated pharmacokinetic and pharmacodynamic modeling of corticosteroids after single and multiple administration. S. Rohatagi, H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf. 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, (1995)

147. Pharmacokinetics and pharmacodynamics of cloprednol. S. Rohatagi, H. Möllmann, J. Barth, G. Hochhaus, H. Derendorf. 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, (1995)

148. Pharmacokinetic and pharmacodynamic modeling of budesonide after single and multiple oral administration. P. Fröehlich, H. Möllmann, H. Derendorf, G. Hochhaus. 10th Annual Meeting of the American Association of Pharmaceutical Scientists, Miami, (1995)

149. PK/PD based characterization of pulmonary targeting of glucocorticoids. G. Hochhaus, S. Suarez, R. Gonzalez-Rothi, H. Derendorf, T. Dalla Costa.IBC International Conference on Pharmacokinetic/Pharmacodynamic Analysis, Washington, (1996)

150. Disposition and blood cell effects of prednisolone and methylprednisolone. S. Rohatagi, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf. 97th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Orlando, (1996)

151. Receptor-based integrated pharmacokinetic and pharmacodynamic evaluation of corticosteroids. H. Derendorf, S. Rohatagi, G. Hochhaus, J. Barth, H. Möllmann. VI World Conference on Clinical Pharmacology and Therapeutics, Buenos Aires, (1996)

152. Ultra-high dosed methylprednisolone in acute spinal cord injury (SCI) - pharmacokinetics and effects on cortisol, potassium, glucose and blood cells. J. Barth, H. Möllmann, A. Möllmann, M. Krieg, U. Bötel, G. Hochhaus, H. Derendorf. VI World Conference on Clinical Pharmacology and Therapeutics, Buenos Aires, (1996)

153. Pharmacokinetics of prednicarbate after dermal, oral and pulmonary administration and monitoring of potential side effects. J. Barth, H. Möllmann, G. Lehr, T. Höhler, H. Derendorf, G. Hochhaus. 6th Annual Meeting of the German Society for Clinical Pharmacology and Therapeutics, Dresden, (1996)

154. Pharmacokinetic/pharmacodynamic relationships relevant for optimizing the effect/risk ratios after topical administration - Pulmonary delivery as an example. G. Hochhaus, R. Gonzalez-Rothi, H. Derendorf, H. Schreier, H. Möllmann. 6th Annual Meeting of the German Society for Clinical Pharmacology and Therapeutics, Dresden, (1996)

155. Pharmacokinetics and -dynamics after application of budesonide pH-modified-release capsules in patients with Crohn‟s disease and healthy volunteers. A. Tromm, H. Möllmann, S.V. Heymann, J. Barth, B. May, G. Hochhaus, H. Derendorf. 6th Annual Meeting of the German Society for Clinical Pharmacology and Therapeutics, Dresden, (1996)

25 156. Modulation of lymphocyte count in blood by the circadian rhythm of endogenous cortisol. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf. 25th Annual Meeting of the American College of Clinical Pharmacology, Philadelphia, (1996)

157. Cumulative cortisol suppression as a measure of the systemic effect of inhaled corticosteroids. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf. 25th Annual Meeting of the American College of Clinical Pharmacology, Philadelphia, (1996)

158. Pharmacokinetic/pharmacodynamic evaluation of budesonide after oral delivery. G. Hochhaus, H. Möllmann, M. Krieg, A. Möllmann, A. Tromm, H. Derendorf, J. Barth. 25th Annual Meeting of the American College of Clinical Pharmacology, Philadelphia, (1996)

159. The effect of dose and release rate on pulmonary targeting of glucocorticoids using liposomes as a model dosage form. S. Suarez, R. Gonzalez-Rothi, G. Hochhaus. 11th Annual Meeting of the American Association of Pharmaceutical Scientists, Seattle, (1996)

160. Circadian rhythm of lymphocytes in blood and its interrelation to endogenous cortisol. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf. 11th Annual Meeting of the American Association of Pharmaceutical Scientists, Seattle, (1996)

161. Pharmacokinetics of inhaled glucocorticoids. H. Derendorf, G. Hochhaus, B. Meibohm, H. Möllmann, J. Barth. Workshop on Inhaled Glucocorticoids, Brussels, (1997)

162. Stability of Budesonide and Triamcinolone Acetonide in Nebulizer Solution. J. Talton, L. Hendeles, G. Hochhaus. Poster, SEAAPS Conference (1997).

163. Pharmacokinetics of inhaled glucocorticoids. Derendorf, G. Hochhaus, B. Meibohm, H. Möllmann, J. Barth Landmark Symposium London, (1997)

164. Time dependency of the pharmacologic response to glucocorticoids. 98th Annual Meeting of the Am. Soc. Clin. Pharmacology & Therapeutics. San Diego, (1997)

165. Pharmacokinetics and pharmacodynamics of soft corticosteroids for inhalation. H. Derendorf, G. Hochhaus, B. Meibohm, H. Möllmann, J. Barth. 1st Drug Optimization via Retrometabolism Conference, Amelia Island, (1997)

166. PK/PD-modeling of the circadian rhythm of the lymphocyte count in blood modulated by endogenous cortisol 1st Drug Optimization via Retrometabolism Conference. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf, Amelia Island, (1997)

167. PK/PD-approach to assess the systemic activity of inhaled corticosteroids as cumulative cortisol suppression. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf. 1st Drug Optimization via Retrometabolism Conference, Amelia Island, Ma (1997)

168. The effects of dose and release rate on pulmonary targeting. S. Suarez, R. Gonzalez-Rothi, H. Schreier, G. Hochhaus. 1st Drug Optimization via Retrometabolism Conference, Amelia Island, (1997)

169. Receptor binding studies of soft anticholinergics. F. Huang, G. Hochhaus, N. Bodor. 1st Drug Optimization via Retrometabolism Conference, Amelia Island, (1997)

170. An AM1-based model for the estimation of the relative binding affinity for glucocorticoids.M.-J. Huang, S. Tamada, G. Hochhaus, N. Bodor. 1st Drug Optimization via Retrometabolism Conference, Amelia Island, (1997)

26 171. Predictive power of PK/PD –modeling for inhaled glucocorticoids. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf. American College of Clinical Pharmacology. 16th Annual Meeting, Phoenix, (1997)

172. Advanced PK/PD model for the modulation of lymphocyte count by glucocorticoids and endogenous cortisol. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth, H. Derendorf. American College of Clinical Pharmacology. 16th Annual Meeting, Phoenix, (1997)

173. Algebraic solutions for non-linear protein binding interactions. S. Rohatagi, G. Hochhaus, A. Kovar, H. Derendorf. American College of Clinical Pharmacology. 16th Annual Meeting, Phoenix, (1997)

174. Basic concepts in pulmonary targeting. G. Hochhaus. American College of Clinical Pharmacology. 16th Annual Meeting, Phoenix, (1997)

175. Pharmacokinetic/Pharmacodynamic aspects of asthma therapy. G. Hochhaus, Physiological Science Seminar 1997, Gainesville, (1997)

176. Pharmacokinetic/Pharmacodynamic aspects of pulmonary targeting of inhaled glucocorticoids. G. Hochhaus, Pharmacy Science Seminar, Richmond. (1997)

177. Pharmacokinetis and pharmacodynamics after inhaled administration of flunisolide. M. Wagner, R. Stöckmann, H.Derendorf, G. Hochhaus, B. Meibohm, J. Barth M. Krieg. XVI International Congress of Allergology & Clinical Immunology, Cancun, (1997)

178. Pharmacokinetics and pharmacodynamic evaluation after single-dose inhaled fluticasone propionate. H.W. Möllmann, M. Wagner, R. Stöckmann, H.Derendorf, B. Meibohm, M. Krieg, G. Hochhaus,. XVI International Congress of Allergology & Clinical Immunology, Cancun, (1997)

179. Pharmacokinetic/pharmacodynamic evaluation of systemic effects of flunisolide after inhalation. H. Möllmann, H. Derendorf, J. Barth, B. Meibohm, M. Wagner, M. Krieg, A. Möllmann, G. Hochhaus. 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November (1997). Pharm Res. 14, S-140 (1997)

180. Pharmacokinetic/pharmacodynamic evaluation of systemic effects of inhaled glucocorticoids. G. Hochhaus, H. Derendorf, B. Meibohm. Pharm Res. 14, S-140 (1997)

181. Chronopharmacology of cortisol suppression during inhaled corticosteroid therapy. B.Meibohm, G. Hochhaus, H. Möllmann, J. Barth and H. 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November (1997). Pharm Res. 14, S-141 (1997)

182. Absorption profiles of inhaled corticosteroids. B. Meibohm, G. Hochhaus, H. Möllmann, J. Barth and H. Derendorf. 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November (1997). Pharm Res. 14, S-141 (1997)

183. Pharmacokinetic/Pharmacodynamic evaluation of systemic effects of inhaled glucocorticoids G. Hochhaus, H. Derendorf, B. Meibohm. 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November (1997). Pharm Res. 14, S-140 (1997)

184. Pharmacokinetic/pharmacodynamic evaluation of systemic effects of budesonide after oral delivery. G. Hochhaus, B. Meibohm, H. Moellmann, H. Derendorf, J. Barth, M. Wagner, M. Krieg, J. Knoeller. 12th Annual Meeting of the American Association of Pharmaceutical Scientists, Boston, November (1997). Pharm Res. 14, S-617 (1997)

185. Basic principles of pulmonary targeting. G. Hochhaus. 31st Annual Higuchi Research Seminar, Lake Ozark (1998)

27

186. Pulmonary targeting of inhaled glucocorticoids: How is it influenced by formulation? G. Hochhaus, S. Suarez, R.J. Gonzalez-Rothi, H. Schreier. Respiratory Drug Delivery VI. Hilton Head, South Carolina (1998)

187. Assessment of pulmonary selectivity of triamcinolone acetonide powders using an ex vivo receptor binding assay. S. Suarez, J.D. Talton. G. Hochhaus. Respiratory Drug Delivery VI. Hilton Head, South Carolina (1998)

188. Pharmacokinetic-Pharmacodynamic modeling of cumulative cortisol suppression by inhaled corticosteroids. H. Derendorf, B. Meibohm, H. Moellmann, J. Barth, M. Wagner, M. Krieg, R. Stoeckmann. 8th International conference on Pharmaceutical Technology, Paris (1998)

189. Effect of formulation aspects on pulmonary targeting of glucocorticoids . G. Hochhaus, S. Suarez, J. Talton, R.J. Gonzalez-Rothi. 8th International conference on Pharmaceutical Technology, Paris (1998)

190. Effect of clearance and volume of distribution on pulmonary targeting of inhaled glucocorticoids. G. Hochhaus, H. Derendorf, B. Meibohm. Measurement and Kinetics of in vivo drug effects Advances in simultaneous pharmacokinetic/pharmacodynamic modeling. Noordwijkerhout, The Netherlands (1998)

191. Interaction between endogenous and exogenous corticosteroids and blood lymphocytes: The buffering capacity of cortisol suppression. G. Hochhaus, B. Meibohm, J. Stark, H. Moellmann, H. Derendorf, M. Wagner. Measurement and Kinetics of in vivo drug effects Advances in simultaneous pharmacokinetic/pharmacodynamic modeling. Noordwijkerhout, The Netherlands (1998)

192. Mechanism based PK/PD model for the interaction between endogenous and exogenous corticosteroids and blood lymphocytes. B. Meibohm, H. Derendorf, H. Moellmann, M. Wagner, G. Hochhaus. Measurement and Kinetics of in vivo drug effects Advances in simultaneous pharmacokinetic/pharmacodynamic modeling. Noordwijkerhout, The Netherlands (1998)

193. Chronopharmacological aspects in cortisol suppression during inhaled corticosteroid therapy. B. Meibohm, G. Hochhaus, H. Moellmann, J. Barth, H. Derendorf. Measurement and Kinetics of in vivo drug effects Advances in simultaneous pharmacokinetic/pharmacodynamic modeling. Noordwijkerhout, The Netherlands (1998)

194. Release characteristics of budesonide from pH-modified release capsules and controlled ileal release capsules. H.W. Moellmann, M. Wagner, A. Tromm, A.C. Moellmann, S. Homrighausen, J. Barth, M. Krieg, G. Hochhaus. American Gastroenterological Association and American Association for the study of Liver Disease. New Orleans (1998)

195. Interaction between endogenous and exogenous corticosteroids and blood lymphocytes: The buffering capacity of cortisol suppression. G. Hochhaus, B. Meibohm, J. Stark, H. Moellmann, H. Derendorf, M. Wagner. American College of Clinical Pharmacology. 17th Annual Meeting, Toronto (1998)

196. Pharmacokinetic/pharmacodynamic relationships for ß2-adrenergic drugs. G. Hochhaus. American College of Clinical Pharmacology. Tanabe Young Investigator recipient lecture. 17th Annual Meeting, Toronto (1998)

197. Dynorphin A1-13 derivatives with enhanced metabolic stability. S. I. Al-Fayoumo, E. Mulder, G. Hochhaus, 13th Annual Meeting of the American Association of Pharmaceutical Scientists, San Francisco, November (1998). Pharm Sci. 1, S-38 (1998)

198. Pulmonary targeting of intratracheal triamcinolone acetonide dry-powder using an ex-vivo receptor binding assay. J. D. Talton, S. Suarez, R. Gonzales-Rothi, G. Hochhaus, 13th Annual Meeting of the American Association of Pharmaceutical Scientists, San Francisco, November (1998). Pharm Sci. 1, S-63 (1998)

28

199. Pulmonary targeting of intratracheal fluticasone propionate dry-powder vs. intravenous solution using an ex-vivo receptor binding assay. J. D. Talton, S. Suarez, R. Gonzales-Rothi, G. Hochhaus, 13th Annual Meeting of the American Association of Pharmaceutical Scientists, San Francisco, November (1998). Pharm Sci. 1, S-63 (1998)

200. A novel assay for the pharmacokinetic/pharmacodynamic analysis of gene delivery in vitro. B.E. Houk, G. Hochhaus, J.A. Hughes, 13th Annual Meeting of the American Association of Pharmaceutical Scientists, San Francisco, November (1998). Pharm Sci. 1, S-471 (1998)

201. Pulsed laser deposited polymer films onto pulmonary dry powders for improved drug delivery. J. Talton, G. Hochhaus, J. Fitz-Gerald, R. Singh. MRS 1998 Fall Meeting, Boston, MA (1998), p 597

202. Investigations on the pulmonary effect-time profile after inhalation of fluticasone propionate. M. Wagner, G. Hochhaus, A.C. Moellmann, M. Krieg, H. Derendorf, H.W. Moellmann. 171th Meeting of the „Rheinisch Westfaelische Gesellschaft fuer Innere Medizin” Duesseldorf (November 1998).

203. Rectal Application of Budesonide foam: A therapeutic advantage?. M. Koelsch, M. Wagner, H. Dimova, G. Hochhaus, A.C. Moellmann, H. Derendorf,H.D. Tauschel, B. May, A. Tromm, H.W. Moellmann. 171th Meeting of the „Rheinisch Westfaelische Gesellschaft fuer Innere Medizin” Duesseldorf (November 1998).

204. Pharmacokinetic/pharmacodynamic evaluation of inhaled glucocorticoids. MUSC, College of Pharmacy, Charleston (October 1998)

205. Pharmacokinetic/pharmacodynamic evaluation of inhaled antiasthmatic agents. G. Hochhaus, University of Colorado, College of Pharmacy, Denver, (January 1999)

206. A physiological Pharmacokinetic (PK) model for beclomethasone dipropionate (BDP) delivered via conventional metered dose inhaler (MDI) and Spiros, an investigational dry powder inhaler (DPI). G. Hochhaus, S. Scranton, LM Vaughan, M. Hill. AAAAI 55th Annual Meeting, Orlando (1999), J. Allergy Clin. Immunol. 103, S135 (1999)

207. Synthesis of Biodegradable Poly(lactic-co-glycolic acid) Films by Pulsed Laser Deposition. J. Talton, G. Hochhaus, J. Fitz-Gerald, R. Singh, Presentation, Materials Research Society, Spring (1999).

208. Factors Influencing Pulmonary Targeting. G. Hochhaus, Boehringer Ingelheim, Ridgefield CT, (May 1999)

209. Pulmonary Targeting of commercially Inhaled glucocorticoids. G. Hochhaus, Retrometabolism Based Drug Design and Conference, Amelia Island Plantation, FL (May 1999)

210. Loteprednol Etabonate - A Soft Steroid for the Treatment of Allergic Diseases of the Airways. S. Szelenvi, G. Hochhaus, H. Dimova, S. Krishnaswami and J. Engel, Retrometabolism Based Drug Design and Conference, Amelia Island Plantation, FL (May 1999)

211. Optimized therapeutic Ratio of Inhaled Corticosteroids Using Retrometabolism. H. Derendorf, G. Hochhaus, S. Krishnaswami, H. Moellman,, Retrometabolism Based Drug Design and Conference, Amelia Island Plantation, FL (May 1999)

212. Pharmacokinetics of plasmid DNA in vitro and after IV bolus administration in the rat. B.E. Houk, G. Hochhaus, J.A. Hughes, Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Durham, NC (1999)

213. Pharmacokinetic/Dynamic considerations for the topical and systemic lung delivery of glucocorticoids and proteins. G. Hochhaus, Southeast Regional Meeting of the American Association of Pharmaceutical Scientists, Durham, NC (1999)

29

214. Pulmonary Targeting: What is important. G. Hochhaus, University of Halle, Halle, Germany (June 1999)

215. Pulmonary targeting of inhaled glucocorticoids. G. Hochhaus. 2nd Symposium on New Developments in Clinical Pharmacy and Clinical Pharmacology, Reims, France (June, 1999)

216. Pharmacokinetics/Pharmacodynamics of budesonide foam after single and multiple dosing. H.W. Möllmann, M. Wagner, A.C. Möllmann, X Koelsch, H. Dimova, Y. Tang, A. Tromm, H.-D. Tauschel, M. Krieg, H. Weisser, H. Derendorf, G. Hochhaus, 28th Annual Meeting of the American College of Clinical Pharmacology, Washington (1999), J. Clin Pharmacol. 39, 985 (1999)

217. Pharmacokinetics of fluticasone propionate (FP) after single and bidaily inhaled administration over 5 days. M. Wagner, G. Hochhaus, H. Derendorf, Y. Tang, A.C. Moellmann, M. Krieg, H.W. Moellmann 28th Annual Meeting of the American College of Clinical Pharmacology, Washington (1999), J. Clin Pharmacol. 39, 985 (1999)

218. PK/PD workshop. Guenther Hochhaus, ESCP 28th Symposium on clinical pharmacy, Berlin 1999

219. Pharmacokineitc/pharmacodynamic modeling of lymphocyte subpopulations after oral budesonide administration. S. Werner, J. Stark, H. Moellmann, S. Homrighausen, H.Derendorf, G. Hochhaus, M. Krieg. 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November (1999). Pharm Sci. 1, Issue 4, # 1060 (1999)

220. Determination of fluticasone propionate in human plasma by liquid chromatography-tandem mass spectrometry. S. Krishnaswami, H. Möllmann, H. Derendorf, G. Hochhaus. 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November (1999). Pharm Sci. 1, Issue 4, # 2017 (1999)

221. Pharmacokinetics of plasmid DNA in vitro and after Iv bolus administration in the rat. B.E. Houk, G. Hochhaus, J.A. Hughes. 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November (1999). Pharm Sci. 1, Issue 4, # 3155 (1999)

222. Pharmacokinetics of fluticasone propionate after single and multiple inhalations. S. Krishnaswami, H. Möllmann, G. Hochhaus, M. Wagner, R. Stöckmann, H. Derendorf. 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November (1999). Pharm Sci. 1, Issue 4, # 3167 (1999)

223. Plasma concentrations and pulmonary targeting of budesonide after intravenous and intratracheal administration in rats. J.D. Talton, G. Hochhaus. 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November (1999). Pharm Sci. 1, Issue 4, # 3669 (1999)

224. Characterization of biodegradable poly(lactic-co-glycolic acid) coatings on budesonide using pulsed laser deposition. J.D. Talton, J.M. Fitz-Gerald, R. Singh, G. Hochhaus. 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November (1999). Pharm Sci. 1, Issue 4, # 3671 (1999)

225. Pulmonary targeting of poly(lactic-co-glycolic acid) coated budesonide dry powders vs uncoated powders using an ex vivo receptor binding assay in rats. J.D. Talton, J.M. Fitz-Ger ald, R. Singh, G. Hochhaus. 14th Annual Meeting of the American Association of Pharmaceutical Scientists, New Orleans, November (1999). Pharm Sci. 1, Issue 4, # 3672 (1999)

226. Computer simulations for assessing pulmonary targeting. G. Hochhaus. Airway activity and selectivity of inhaled steroids (IS) in asthma- Mechanism, models of evaluation and clinical impacts. Palm Beach, Florida, December 1-3, 1999

30 227. How does PK/PD modeling affect the selection of a dose. G. Hochhaus. Accelerating PK/PD drug development: biomarkers & surrogate endpoints, modeling outcomes & toxicity. Washington, DC, January 27-28, 2000

228. Streamlining dosing requirements with mechanism-based PK/PD modeling. G. Hochhaus. Clinical pharmacokinetics and pharmacodynamics. Arlington, VA, February 28-29, 2000

229. Coating of Steroid Particles. G. Hochhaus. Recent advantages in pressurized inhalers. London, UK, March 2-3, 2000

230. Pharmacokinetic/Pharmacodynamic aspects of pulmonary delivery of liposomes. G. Hochhaus7th Liposome Research Days Conference. Napa Valley. April 12-15, 2000.

231. Nano-thin coatings for improved lung targeting of glucocorticoid dry powders: In-vitro and In-vivo characteristics. J. Talton, J. Fitz-Gerald, R. Singh, G. Hochhaus. Respiratory Drug Delivery VII, Tarpon Springs, May 14-18, 2000

232. Fluticasone propionate (FP plasma concentrations in children with asthma. O. Bessmertny, J. Liang, G. Hochhaus, S. Chesrown, L. Hendeles. ATS 2001, San Francisco, CA May 18-23, 2001.

233. Effect of Holding Chambers on In Vitro Respirable Dose of Fluticasone from a Metered-Dose Inhaler M. J. Asmus, Z. M. Liang, I. Coowanitwong, G. Hochhaus 2000 AAPS Annual Meeting , Indianapolis, IN. 2000. AAPS PharmSci Supplement 2000;2(4), available at http//www.aapspharmaceutica.com/scientificjournals/pharmsci/am_abstracts/2000/627.html

234. Pharmacokinetic/Pharmacodynamic Modeling of Inhaled Fluticasone Propionate S. Krishnaswami, G. Hochhaus, H. Moellmann, M. Wagner, R. Stockmann, H. Derendorf, 2000 AAPS Annual Meeting, Indianapolis, IN., Nov. 2000.

235. Effect of Spacers on In-Vitro Respirable Dose of Fluticasone Propionate From a Metered-Dose Inhaler M. J. Asmus, Z. M. Liang, I. Coowanitwong, G. Hochhaus, 2000 AAPS Annual Meeting, Indianapolis, IN., 2000. AAPS PharmSci Supplement 2000;2(4), available at http//www.aapspharmaceutica.com/scientificjournals/pharmsci/am_abstracts/2000/906.html

236. Simultaneous Determination of the Glucocorticoid Soft Drug Loteprednol Etabonate, PJ91 and Cortisol in Plasma by Liquid Chromatography-Tandem Mass Spectromerty H. G. Dimova, S. Krishnaswami, G. Hochhaus, 2000 AAPS Annual Meeting, Indianapolis, IN., Nov. 2000.

237. Interplay of Endogenous and Exogenous Corticosteroids and the Effects on Blood Lymphocytes J. G. Stark, H. Derendorf, H. Mollmann, G. Hochhaus, 2000 AAPS Annual Meeting, Indianapolis, IN., Nov. 2000.

238. Sustained Release Formulations of Rifampin for Inhalation Therapy I. Coowanitwong, J. D. Talton, R. Singh, J. A. Hughes, G. Hochhaus, J. M. Fitz-Gerald, 2000 AAPS Annual Meeting, Indianapolis, IN, Nov. 2000

239. Stabilization of cellular membranes by glucocorticosteroids: demonstration of dose-dependency in an ex vivo/in vitro model using human erythrocytes. J. Barth, M. Cziborra, H.W. Moellmann, D. Jaeger, G. Hochhaus. ACJ International, Suppl 2:11, 2000. XVII International Congress of Allergology & Clin. Immunology. South Australia, Oct. 2000.

240. Pharmacokinetics of fluticasone propionate (FP) after inhalation into the lung and nose. A.C. Moellmann, M. Wagner, G. Hochhaus. H. Derendorf, H. Dimova, S. Krishnaswami, M. Krieg, H.W. Moellmann. ACJ International, Suppl 2:11, 2000. XVII International Congress of Allergology & Clin. Immunology. South

31 Australia, Oct. 2000.

241. Endogenous cortisol after inhalation of fluticasone propionate and budesonide over 5 days. M. Wagner, G. Hochhaus, A.C. Möllmann, H. Derendorf, R. Stöckmann, M. Krieg, J. Barth, H.W. Möllmann. ACJ International, Suppl 2:119, 2000. XVII International Congress of Allergology & Clin. Immunology. South Australia, Oct. 2000.

242. PK/PD modeling : Does it have a future in drug development. AGAH Annual Meeting 2001. Dresden, Germany, February 2001.

243. Home-made spacer in vitro performance with a fluticasone metered dose inhaler. M.J. Asmus, J. Kiang, I. Coowanitwong, G. Hochhaus, 57th Annual Meeting AAAAI, New Orleans, LA, March 16-21, 2001.. J. Allergy Clin Immunol. 107, S103, 2001

244. Comparison of aerochamber and aerochamber-plus valved holding chamber in vitro performance with a fluticasone metered dose inhaler. J. Liang, M.J. Asmus, I. Coowanitwong, G. Hochhaus, 57th Annual Meeting AAAAI, New Orleans, LA, March 16-21, 2001. J. Allergy Clin Immunol. 107, S103, 2001

245. Low flow rate in vitro performance of fluticasone inhaled delivery systems used in the dice trial, M.J. Asmus, J. Liang, I. Coowanitwong, G. Hochhaus. 57th Annual Meeting AAAAI, New Orleans, LA, March 16-21, 2001. Am. J. Resp. Critical Care, 165, A444 (2001)

246. Respirable dose of fluticasone from a metered dose inhaler (MDI) and two dry-powder inhalers (DPI). M.J. Asmus, J. Liang, I. Coowanitwong, G. Hochhaus. 57th Annual Meeting AAAAI, New Orleans, LA, March 16-21, 2001. Am. J. Resp. Critical Care, 165, A444 (2001)

247. In vitro performance characteristics of MDI spacers with fluticasone. M.J. Asmus, J. Liang, I. Coowanitwong, G. Hochhaus. 57th Annual Meeting AAAAI, New Orleans, LA, March 16-21, 2001. Am. J. Resp. Critical Care, 165, A444 (2001)

248. In vitro performance characteristics of rigid valved holding chambers (VHC) with fluticasone. M.J. Asmus, J. Liang, I. Coowanitwong, G. Hochhaus. 57th Annual Meeting AAAAI, New Orleans, LA, March 16-21, 2001

249. Fluticasone propionate (FP) plasma concentrations in children with asthma. O. Bessmertny, J. Liang, G. Hochhaus, S. Chesrown, L. Hendeles. ATS 2001, San Francisco, May 2001.

250. Attenuation of Gentamicin Induced Nephrotoxicity by Interaction of Strychnine with a Putative Glycine Receptor. A. Arya, S.I. Fayoumi, S. Thamilselvan, S.R. Khan, G. Hochhaus. AAPS, Pharmaceutical Congress of the Americas, Orlando, FL March 24-29, 2001.

251. Comparison of Two Sustained-Release Inhaled rifampin Formulations Prepared by Pulse Laser Deposition (PLD) and Spray Drying. I. Coowanitwong, J.D. Talton, J.M. Fitz-Gerald, R. Singh, P. Kulvanich, J.A. Hughes, G. Hochhaus. AAPS, Pharmaceutical Congress of the Americas, Orlando, FL March 24-29, 2001.

252. Pharmacokinetic/Pharmacodynamic Modeling of Budesonide After Oral Administration in Single and Multiple Doses. P.E. Fröehlich, H. Derendorf, G. Hochhaus, B. Meibohm, H. Möllmann. AAPS, Pharmaceutical Congress of the Americas, Orlando, FL March 24-29, 2001.

253. The Influence of Administration Time on the systemic Effects Observed During Corticosteroid Therapy. J.G. Stark, H. Derendorf, H. Moellmann, G. Hochhaus. AAPS, Pharmaceutical Congress of the Americas, Orlando, FL March 24-29, 2001.

32 254. Pharmaceutical Considerations for Laser Ablation Based Coatings. G. Hochhaus. Industrial Advisory Board/Science Advisory Board Meeting, Gainesville, FL April 24-25, 2001

255. Laser-Polymer Interactions for Controlled Drug Delivery Systems. V. Craciun, W-S. Kim, I. Coowanitwong, G. Hochhaus, M. Ollinger, K.R. Rau and R.K. Singh. Industrial Advisory Board/Science Advisory Board Meeting, Gainesville, FL April 24-25, 2001

256. Pharmaceutical Considerations for Laser Ablation Based Coatings. G. Hochhaus. Industrial Advisory Board/Science Advisory Board Meeting, Gainesville, FL April 24-25, 2001

257. Pharmaceutical Considerations for Laser Ablation Based Coatings. G. Hochhaus. IFPRI 2001 ERC visit, Gainesville, FL June 6, 2001

258. Comparison of fluticasone aerosol in vitro deposition via Gentle-Haler, Optihaler, and conventual MDI actuator , M.J. Asmus, J. Liang, I. Coowanitwong, G. Hochhaus. Journal of Aerosol Medicine, 14, 410 (2001)

259. The effect of volume on in-vitro performance characteristics of an MDI spacer fashioned from plastic cold drink bottle. M.J. Asmus, S. Amburgy, J. Liang, R. Vafadari R., I. Coowanitwong, G. Hochhaus. Pharmacotherapy 21, 1295 (2001)

260. Development of a boothstrap procedure for resampling pharmacokinetic data. V. Arya, A. Agarwal, E. Nunan, T. Santos, G. Hochhaus. AAPS Annual Meeting, Denver, CO, Oct. 21-25, 2001.

261. Population pharmacokinetics of methylprednisolone in patients with acute spinal cord injury. J. Kurz, N.V. Nagaraya, S. Balbach, J. Barth, R. Schuhmann, G. Hochhaus, H. Moellmann, H. Derendorf. AAPS Annual Meeting, Denver, CO, Oct. 21-25, 2001.

262. Ultrathin coatings for pulmonary drug delivery. G. Hochhaus, I. Coowanitong, S.-K. Kim, V. Craciun, R. Singh. Presentation, Materials Research Society, Fall (2001) , Boston, November, 2001.

263. Fundamental studies on nanoencapsulated pulmonary drug delivery systems. W.S. Kim, M. Ollinger, V. Craciun, R. Singh, , I. Coowanitong, G. Hochhaus, H. Hofmann, R. Houriet, N. Koshizaki. Presentation, Materials Research Society, Fall (2001), Boston, November, 2001.

264. Pharmacokinetic data analysis via bootstrap resampling. V. Arya, A. Agarwal, G. Hochhaus. AAPS Short Course on Computer Simulation and its role in Drug Development Research. Arlington, Virginia, Jan 28- 29, 2002

265. The perils of prescription, introduction and case studies, D. Benjamin, G. Hochhaus, AGAH Annual Meeting, Garmisch-Partenkirchen, Jan 27-29, 2002

266. Population Pharmacokinetics/Pharmacodynamics of Ciclesonde. S. Rohatagi, V. Arya, K. Zech, J. Barrett, G. Hochhaus, B. Jensen. AAAAI, 58th Annual Meeting, New York. J Allergy Clin. Immunol., 716 (2002)

267. Clinical Pharmacokinetics and Pharmacodynamics. Building the foundation for optimal predictions of drug design, action and dose (Short course). Institute for International Research, Philadelphia, March 11-12 2002.

268. Common Valved Holding Chamber In-Vitro Performance With a Beclomethasone HFA Metered-Dose Inhaler. Kwon SH, Asmus MJ, Coowanitwong I, Khorsand N, Hochhaus G. American Journal of Respiratory and Critical Care Medicine. 2002;165(5):in-press.

33 269. Relative Amount of Inhaled Fluticasone Delivered to The Airways of Asthmatic Children by Two Similar MDI Chambers. Liang J, Asmus MJ, Hochhaus G, Chesrown SE, Hendeles L. Journal of Allergy and Clinical Immunology. 2002;109(1):S242.

270. Approaches to slow release pulmonary drug delivery. Guenther Hochhaus. Particles 2002, Orlando (April 2002)

271. Receptor based PK/PD Modeling. Guenther Hochhaus. 7. Pharmacokinetic/pharmacodynamic Expertentreffen Heiligkreuztal (April 2002)

272. Pulmonary Targeting of Ciclesonide and its active Metabolite as determined in an ex-vivo rat receptor binding assay. G. Hochhaus, J. Talton, M. Stoeck. European Respiratory Society Annual Meeting. Stockholm, October 2002.

273. The Design and Development of the Optimal Inhalation Drug: A PK/PD based discussion. G. Hochhaus. Business and Clinical Developments in Aerosol Therapy. Institute for International Research. Boston, November 2002

274. Inhaled Corticosteroids: Potency vs Efficacy-What really matters. G. Hochhaus. ACAAI. San Antonio, November 2002.

275. Pharmacokinetic/pharmacodynamic evaluations of inhalation drugs. G. Hochhaus. Rio De Janeiro, College of Pharmacology, November 2002.

276. Pharmacokinetic/pharmacodynamic modeling for streamlining drug development. G. Hochhaus. Brazilian Congress of Pharmacology, Aguas de Lindoia, November 2002.

277. Pharmacokinetic/dynamic aspects for targeting drugs to the lung. G. Hochhaus. College of Pharmacy, University of Sao Paulo, Ribeirao Preto, November 2002.

278. Role of p-glycoprotein transporters in the brain permaeability of inhaled glucocorticoids. M. Issar, V. Arya, S. Shresta, G. Hochhaus. AAPS Annual Meeting, Toronto, Canada, November, 2002.

279. Pulmonary targeting of beclomethasone dipropionate in rats. Y. Wang, G. Hochhaus. AAPS Annual Meeting, Toronto, Canada, November, 2002.

280. Use of microdialysis to evaluate dexamethasone tissue distribution after oral and topical administration. M. Muller, V.A. Schuck, M. Grant, H. Derendorf, G. Hochhaus. AAPS Annual Meeting, Toronto, Canada, November, 2002.

281. Pulmonary Targeting: What are the critical issues involved? G. Hochhaus. AstraZeneca, 17th December 2002.

282. The clinical relevance of pharmacokinetic and pharmacodynamic data. G. Hochhaus. Current trends in allergic reactions. A multidisciplinary approach to patient care. NIAID/ NIH. Bethesda, Maryland, February 2003.

283. Relative Amount of Inhaled Fluticasone Delivered to The Airways of Asthmatic Children by Two Similar MDI Chambers. Liang J, Asmus MJ, Hochhaus G, Chesrown SE, Hendeles L. Journal of Allergy and Clinical Immunology. 2002;109(1):S242.

284. Inhaled Corticosteroids: Pharmacokinetic and Pharmacodynamics. G. Hochhaus. ATS Annual Meeting, Seattle May 19, 2003

34 285. PK/PD of inhaled Glucocorticoids-New Developments. G. Hochhaus. 4th Retrometabolism based drug design and targeting conference, Palm Coast, May 2003

286. New Developments in Corticosteroids. G. Hochhaus. Congress on inhaled Corticosteroids in the treatment of Asthm,a and COPD. July 2003, New York.

287. An In-Vitro Comparison of Two Non-Electrostatic Valved Holding Chambers with a Fluticasone Metered- Dose Inhaler. Asmus MJ, Arya V, Hochhaus G. Chest. 2003;124(suppl 4): (in-press).

288. In-Vitro Comparison of Fluticasone Respirable Dose from a Metered Dose Inhaler and Three Rigid Valved Holding Chambers. Asmus MJ, Wu K, Arya V, Hochhaus G. Chest. 2003;124(suppl 4): (in-press).

289. S. Sahasranaman, M. Issar, G. Hochhaus. Metabolism of mometasone furoate in rat and human liver, lung and plasma. Retrometabolism Based Drug Design and Targeting Conference, May 2003. Is the binding of inhaled glucocorticoids to the glucocorticoid receptors specific? M. Issar, S. Sahasranaman, G. Hochhaus. Annual Meeting of the American Association of Pharmaceutical Scientists, October 2003.

290. S. Why does mometasone furoate exhibit low systemic exposure after oral inhalation? Sahasranaman, M. Issar, G. Hochhaus. Annual Meeting of the American College of Clinical Pharmacology, September 2003.

291. S. Sahasranaman, M. Issar, G. Toth, G. Horvath, G. Hochhaus. Degradation of mometasone furoate in the lung. Annual Meeting of the American Academy of Allergy, Asthma, and Immunology, March 2004.

292. Differences in selectivity of inhaled glucocorticoids to the glucocorticoid receptor. M. Issar, S. Sahasranaman, G. Hochhaus. Annual Meeting of the American Academy of Allergy, Asthma, and Immunology, March 2004.

293. Optimizing pharmaceutical properties of inhalation drugs. G. Hochhaus. Respiratory Drug Delivery IX, Palm Springs, April 2004

294. Impact of New Anti-Static valved-holding chamber on airway delivery of inhaled fluticasone propionate in asthmatic children. M.J. Asmus, G. Hochhaus, Y. Tang, L.T. Spencer, S.E. Chesrown, L. Hendeles. ATS 2004, Orlando, May 2004.

295. Effect of MDI valved holding chamber antistatic coating on bioavailability of inhaled fluticasone in subjects with asthma. M.J. Asmus, G. Hochhaus, Y. Tang, S.E. Chesrown, L. Hendeles. ATS 2004, Orlando, May 2004.

296. Population Pharmacokinetics of Levofloxacin in a Medical Intensive Care Unit Z. R. Tayab, S. Kaufmann, G. Hochhaus, D. Jager, and J. Barth.., American College of Clinical Pharmacology. Phoenix, Arizona. October, 2004.

297. A Sensitive and Specific LC/MS/MS Assay for the Detection of Mometasone Furoate in Human Plasma. Y. Tang, S. Sahasranaman, D. Biniasz, G. Hochhaus. AAPS Annual Meeting, Baltimore, November 2004

298. Pharmacological Properties of the Metabolites of Mometasone Furoate. S. Sahasranaman, M. Issar, G. Hochhaus. AAPS Annual Meeting, Baltimore, November 2004

299. Relative anti-inflammatory potency of corticosteroids measured by AP-1-inhibitory potency. N. Dirks, S.Li, C. Yates, G. Hochhaus, B. Meibohm. AAPS Annual Meeting, Baltimore, November 2004

300. PK/PD of inhaled glucocorticoids. Las Vegas March 2005, Summit Speaker Education

35

301. Nanothin Coatings for pulmonary delivery: A method to improve the local selectivity of inhalation drugs. G. Hochhaus. FDA Course: “The use of Nanotechnology in New Drug Development.” Rockville, March 2005

302. PK/PDModeling as Tool in per-clinical and clinical Drug Development. Guenther Hochhaus. 19th JSSX, Tokyo, April 2005

303. Is the distribution of glucocorticoids affected by transporters. G. Hochhaus. 5th Retrometabolism Conference. Hakone, Japan, May 2005

304. Pharmacokinetic Evaluation of dosage forms for colonic delivery. Guenther Hochhaus. 32 Annual meeting and exposition of the controlled release society. Miami, June 2005

305. Glucocorticoid transrepression and transactivation potencies as measured by inhibition of AP-1, NF- B and activation of GRE. N.L. Dirks, S. Li, G. Hochhaus, C.R. Yates, B. Meibohm. AAPS, Nashville, TN Nov. 2005

306. Effects of the administration time on the cumulative cortisol and lymphocytes suppression of inhaled corticosteroids. K. Wu, J. Stark, H. Derendorf, G. Hochhaus, AAPS, Nashville, TN, Nov. 2005.

307. A pharmacokinetic/pharmacodynamic evaluation of fluticasone propionate and mometasone furoate using adrenal suppression as a surrogate marker. Z.R. Tayab, T.C. Fardon, D.K.C. Lee, K. Haggart, L.C. McFarlane, B.J. Lipworth and G. Hochhaus, AAPS, Nashville, TN, Nov. 2005.

308. ICS Pharmacokinetics: the key for improving Safety and efficacy. Guenther Hochhaus. ACAAI, Annual Scientific meeting. Anaheim November 2005

309. The Science: Advancing Inhaled Corticosteroid Pharmacology. Guenther Hochhaus. Southeastern Allergy Forum, Eastern Allergy Forum, Puerto Vallarta, January 2006

36 BIOGRAPHY MICHAEL A. SCHWARTZ

PERSONAL Date of Birth: August 4, 1930

EDUCATION 1952 B.S. in Pharmacy Brooklyn College of Pharmacy 1956 M.S. Columbia University, College of Pharmacy 1959 Ph.D. University of Wisconsin Major Professor Takeru Higuchi Dissertation Mediation of Complex Formation in the Hydrolysis of Sarin 1956-59 Fellow American Foundation for Pharmaceutical Education

EXPERIENCE

1952 - 1954 Military Service Pharmacist, Tokyo Army Hospital, U.S. Army Medical Service

Aug. 1959 - April 1963 Senior Research Scientist Bristol Laboratories, Syracuse, New York

May 1963 - June 1965 Assistant Professor of Pharmaceutics, School of Pharmacy, State University of New York at Buffalo

July 1965 - June 1966 Associate Professor of Pharmaceutics, SUNY/Buffalo

July 1966 - March 1970 Assistant Dean, School of Pharmacy and Associate Professor of Pharmaceutics, SUNY/Buffalo

Administrative responsibilities included student affairs (admissions, review, recruitment, and advisement), development of continuing education programs, professional relations (state and national). Continued teaching, research and supervision of graduate students.

April 1970 - June 1976 Dean, School of Pharmacy and Professor of Pharmaceutics, SUNY/Buffalo

Responsible for management of the academic programs and administration of the School of Pharmacy. Major accomplishments included implementation of the Doctor of Pharmacy degree program, development of the first clinical pharmacokinetics laboratory, development of postdoctoral clinical fellowships providing research training for clinical scientists. The school was ranked among the top ten schools of pharmacy.

1

June 1974 Member, U.S. Herbal Pharmacology Delegation to People's Republic of China

July 1976 - April 1978 Professor of Pharmaceutics SUNY/Buffalo

Returned to full time teaching in graduate and undergraduate pharmaceutics and research. Carried out major study of drug shortages in the U.S. This study was funded by the Center for the Study of Drug Development (then at University of Rochester)and resulted in publication of a book.

April 1978 - May 31, 1996 Dean and Professor, College of Pharmacy, University of Florida

Responsible for management of academic programs and administration of the College of Pharmacy, which encompassed a budget (all sources) of about $12 M, and a faculty of 54 in five academic departments. Major accomplishments include increase in state budget from $1.3 M to $6 M, increase in external funding from $240,000 to over $6 million, development of external clinical teaching sites throughout the state with a large adjunct clinical faculty, development of the entry Doctor of Pharmacy program. Major activities include strategic planning, development of a private giving program and enhancement of the graduate program in the pharmaceutical sciences.

June 1, 1996 – June 30, 2003 Dean Emeritus and Professor of Pharmaceutics and Pharmacy Health Care Administration, College of Pharmacy, University of Florida

July 1, 2003 – Present Dean Emeritus, University of Florida, College of Pharmacy

Sept. 1989 - February 1990: Scholar in Residence, American Association of Colleges of Pharmacy

Developed case studies in strategic planning in colleges of pharmacy to be used in training programs for deans, department chairmen and other administrators; authored a paper on the role of strategic planning in pharmacy's future.

2 CONSULTANT TO:

Bristol-Myers Co. (1968-78) in Pharmaceutics Research Academy of Pharmaceutical Sciences (1984-86) in Strategic Planning Alabama Pharmaceutical Association (1986) in Strategic Planning Center for Pharmaceutical Sciences and Technology - University of Kentucky (1986) in Strategic Planning Strategic Planning Consultant (1989-90) to: University of Cincinnati College of Pharmacy St. Louis College of Pharmacy Medical College of Virginia School of Pharmacy Massachusetts College of Pharmacy (1995-7) in Strategic Planning Amer. Assn. of Colleges of Pharmacy (1994-5) in Strategic Planning National Pharmacy Cholesterol Council (1996) in Strategic Planning America Pharmaceutical Assn. Foundation (1997) in Strategic Planning Florida Pharmacy Assn. (1996-7) in Strategic Planning Louisiana Board of Regents (1997) on Pharm. D. at NE Louisiana Univ.

MEMBERSHIPS

Member, Pharmaceutical Sciences Section Committee, 1978-81 American Pharmaceutical Association Elected Board of Trustees, 1982-84 Chairman, Policy Committee on Scientific Affairs, 1980 Member, APhA Foundation Board of Trustees, 1985 - 1994 Member, Strategic Planning Committee 1996-7 American Society of Hospital Pharmacists Member, Commission on Goals, 1993-5 American Association of Colleges of Pharmacy Chairman, Professional Affairs Committee, 1982-83 American Association of Pharmaceutical Scientists Chairman, Strategic Planning Committee, 1986-87 APhA, Academy of Pharmaceutical Sciences Co-Chairman, Program Committee, 1980-81; Chairman, 1981-82 Research Funding Committee, Vice Chairman, 1982-83, Chairman, 1983-84 Founding Member, Higuchi Research Prize Committee Chair, Strategic Planning Committee, 1984-6 Florida Pharmacy Association Florida Pharmacy Association Foundation Member, Board of Directors, 1998 - American Society for Training and Development

HONORS APhA's Hugo H. Schaefer Award - March 1995 APhA Foundation Research Achievement Award for Stimulation of Research – 1986

3 Distinguished Alumnus, Arnold and Marie Schwartz College of Pharmacy and Health Sciences (formerly Brooklyn College of Pharmacy), 1992 Citation of Merit, University of Wisconsin, 2007 Fellow, APhA Academy of Pharmaceutical Sciences Fellow, American Association of Pharmaceutical Scientists Fellow, American Association for the Advancement of Science Elected to Rho Chi (Honorary Pharmaceutical Society) – 1955 Elected to Phi Lambda Sigma (Pharmacy Leadership Society) – 1981 Elected to Sigma Xi (Honorary Research Society) – 1956 Member, American Council on Pharmaceutical Education, 1990-96

OTHER PROFESSIONAL AND COMMUNITY ACTIVITIES Member, Board of Directors, ANDRX Corp. 1993-2003 Member, Board of Directors, Jewish Council of North Central Florida Vice president (1998-2000), President (2000-2002) Member, Board of Directors, Big Brothers/Big Sisters of Gainesville (1997-2002) Vice president (1997-9), President (1999-2000) Member, Board of Advisors, B'nai Brith Hillel at UF

4 PUBLICATIONS

1. Schwartz, M.A., Kuramoto, R. and Malspeis. L., "Chromatographic Separation and Analysis of Naphazoline and its Hydrolytic Degradation Products", J. Am. Pharm. Assn., Sci. Ed., 45, 814 (1956).

2. Higuchi, W.I., Schwartz, M.A., Rippie, E.G., and Higuchi, T., "A Thermometric Method for Determination of Thermodynamic Activity and Molecular Weight", J. Phys. Chem., 63, 996 (1959).

3. Schwartz, M.A., Granatek, A.P., and Buckwalter, F.H., "Stability of Potassium Phenethicillin I. Kinetics of Degradation in Aqueous Solution", J. Pharm. Sci., 51, 523 (1962).

4. Schwartz, M.A. and Buckwalter, F.H., "Pharmaceutics of Penicillin", J. Pharm. Sci., 51, 1119 (1962).

5. Schwartz, M.A., "Catalysis of Penicillin Hydrolysis by Catechol and 3,6-bis(dimethylaminomethyl)-catechol", J. Pharm. Sci., 53, 1433 (1964).

6. Schwartz, M.A., "The Mechanism of Degradation of Penicillin G in Acidic Solution", J. Pharm. Sci., 54, 472 (1965).

7. Schwartz, M.A., Bara, E., Rubycz, I, and Granatek, A.P., "Stability of Methicillin", J. Pharm. Sci., 54, 149 (1965).

8. Schwartz, M.A. and Nelson, E., "Drug Stability", Chapter in Husa's Pharmaceutical Dispensing, 6th Edition, Mack Publishing Co., Easton, PA, 1966.

9. Schwartz, M.A., "Model Catalysts Which Simulate Penicillinase I. Effect of Ionic Interaction on Catalysis of Penicillin Hydrolysis by Certain Catecholamines", J. Pharm. Sci., 54, 1308 (1965).

10. Schwartz, M.A. and Wu, Gay-May, "Kinetics of Reactions Involved in Penicillin Allergy I. Mechanism of Reaction of Penicillins and 6-Aminopenicillanic Acid with Glycine in Alkaline Solution", J. Pharm. Sci., 55, 550 (1966).

11. Schwartz, M.A. and Amidon, G.L., "The Reaction of Aspirin with Amines, a Potential Mechanism for Aspirin Allergy", J. Pharm. Sci., 55, 1464 (1966). (Abstract).

12. Wicher, K., Arbesman, C.E., Schwartz, M.A. and Milgrom, F., "Antibodies to Proteins Conjugated with Aspiryl Chloride", Fed. Proc., 25, 726 (1966).

5 13. Gibaldi, M. and Schwartz, M.A., "The Pharmacokinetics of Penamecillin", Brit. J. Pharmacol. and Chemother., 28, 360 (1966).

14. Schwartz, M.A., "Penicillin Allergy and the Community Pharmacist", J. Amer. Pharm. Assn., NS7, 28 (1967).

15. Schaeffer, H.J., Schwartz, M.A. and Odin, E., "Enzyme Inhibitors XVI. Kinetic Studies on the Irreversible Inhibition of Adenosine Deaminase", J. Med. Chem., 10, 686 (1967).

16. Schwartz, M.A. and Pflug, G.R., "Model Catalysts Which Simulate Penicillinase II. Mechanism of Hydrolysis of Penicillins Catalyzed by Catechol", J. Pharm. Sci., 56, 1459 (1967).

17. Wicher, K. and Schwartz, M.A., "Inhibition of Antisera to Aspiryl Protein Conjugated by Salicylamide Derivatives", Fed. Proc., 26, 580 (1967).

18. Gibaldi, M. and Schwartz, M.A., "Apparent Effect of Probenecid on the Distribution of Penicillins in Man", Clin. Pharmacol. and Therapy, 9, 345-9 (1968).

19. Schwartz, M.A., "Aminolysis of Benzylpenicillin by Aliphatic Diamines", J. Pharm. Sci., 57, 1209 (1968).

20. Kinget, R.D. and Schwartz, M.A., "Model Catalysts Which Simulate Penicillinase III. Structure-Reactivity Relationship in Catalysis of Penicillin Hydrolysis by Morpholinomethyl Derivatives of Catechol and Pyrogallol", J. Pharm. Sci., 57, 1916 (1968).

21. Wicher, K., Schwartz, M.A., Arbesman, C.E., and Milgrom, F., "Immunologic Studies on Aspirin I. Antibodies to Aspiryl-Protein Conjugates", J. Immunology, 101, 342 (1968).

22. Schwartz, M.A., "Catalysis by Poly-L-lysine of Aminolysis of Penicillin by Tris(hydroxymethyl)aminomethane", J. Med. Chem., 12, 36 (1969).

23. Schwartz, M.A., "Chemical Aspects of Penicillin Allergy", (a review) J. Pharm. Sci., 58, 643 (1969).

24. Gibaldi, M., Schwartz, M.A., and Plaut, M.E., "Serum Levels of Penicillin, a Pharmacokinetic View", Antimicrobial Agents and Chemotherapy, 378 (1968).

25. Kinget, R.D. and Schwartz, M.A., "Model Catalysts Which Simulate Penicillinase IV. Steric and Electronic Effects in the Catalysis of Hydrolysis of Penicillins and Cephalothin by Aminolkylcatechols", J. Pharm. Sci., 58, 1102 (1969).

6 26. Schwartz, M.A. and DelDuce, A.J., "Kinetic Analysis of Penicilloic Acid and Penicilloamides in Combination. Application to Products of Reaction of Penicillin with Tris and Poly-L-lysine", J. Pharm. Sci., 58, 1137 (1969).

27. Gibaldi, M., Davidson, D., Plaut, M.E., and Schwartz, M.A., "Modification of Penicillin G. Distribution and Elimination by Probenecid", Int. J. Clin. Pharmacol., Therapy and Toxicology, 3, 182 (1970).

28. Tutt, D.E. and Schwartz, M.A., "Cycloamylose Catalyzed Hydrolysis of Penicillins", Chem. Comm., 113 (1970).

29. Schwartz, M.A., Editorial, "Chemistry and Drug Allergy", Review of Allergy, 24, 249 (1970).

30. Tutt, D.E. and Schwartz, M.A., "Model Catalysts Which Simulate Penicillinase V. The Cyclopheptaamylose-Catalyzed Hydrolysis of Penicillins", J. Am. Chem. Soc., 93, 787 (1971).

31. Tutt, D.E. and Schwartz, M.A., "The Spectrophotometric Assay of Ampicillin (alpha- aminobenzylpenicillin) Involving Initial Benzoylation of the Side Chain Amino Group", Anal. Chem., 43, 338 (1971).

32. Schwartz, M.A., "Stabilization" Chapter, Dispensing of Medication, E.W. Martin, Ed., Mack Publishing Co., Easton, PA (1971). 33. Schwartz, M.A., "The Drug Store and Pharmacy", J. Am. Pharm. Assn., NS12, 66 (1972).

34. Schwartz, M.A. and Hayton, W., "An Explanation of the Relative Stability of Hetacillin and Ampicillin in Solution", J. Pharm. Sci., 61, 906 (1972).

35. Schaeffer, H.J., Johnson, R.M., Schwartz, M.A., and Schwender, C.F., "Enzyme Inhibitions 25. An Equation to Calculate the Unknown Ki from Two Known Values of an R, S, and RS Series. Stereo-Selectivity of Inhibition of Adenosine and Deaminase by (R)-, (S)-, and (RS)-9-(1-hydroxy-2-alkyl and aralkyl) adenines", J. Med. Chem., 15, 456 (1972).

36. Schwartz, M.A., "Approaching the Future of Community Pharmacy", Drug Intel. and Clin. Pharm., 8, 65 (1974).

37. Schwartz, M.A., "Educational Needs for Pharmacy Practice in the Year 2000", Drug Intel. and Clin. Pharm., 9, 451 (1975).

38. Schwartz, M.A., "A Comprehensive Curriculum for Continuing Education in Pharmacy", Am. J. Pharm. Educ., 40, 327 (1975).

7 39. Schwartz, M.A., "The House that Jack Built", A Commentary on the Millis Commission Report, Drugs in Health Care, 3, 62 (1976).

40. Schwartz, M.A., "Role of the Pharmacist in the Patient Health Team Relationship", Chapter 8 in Principles and Techniques of Human Research in Therapeutics, Vol. X, Patient Compliance, L. Lasagna, Ed., Futura Press, Mt. Kisco, NY (1976).

41. Schwartz, M.A., "Factors Influencing Formation of Antigens from Penicillin", Alfred Benzon Symposium, Drug Design and Adverse Reactions, Munksgaard, Copenhagen (1977).

42. Schwartz, M.A., "An Analysis of the Institute of Medicine Cost Study", Am. J. Pharm. Educ., 40, 456 (1976).

43. Schwartz, M.A., "Teaching Effectiveness and Research Activity in Schools of Pharmacy; They are Related", Am. J. Pharm. Educ., 41, 402-405 (1977).

44. Schwartz, M.A., "Non-Enzymic Analogs of Beta-lactamases", Chapter in Beta-Lactamases, J.M.T. Hamilton-Miller and J.T. Smith, Eds., Academic Press, London (1979).

45. Schwartz, M.A., “Prescription Drugs in Short Supply: Case Histories”, Marcel Dekker, NY (1980).

46. Schwartz, M.A., "The No B.S.-Pharm.D. Degree", Drug Intel. and Clin. Pharm., 14, 37-39 (1980).

47. Schwartz, M.A., "Catalysis of Hydrolysis and Aminolysis of Benzyl-penicillin Mediated by a Ternary Complex with Zinc Ion and Tris (hydroxymethyl)amino-methane", Bioorg. Chem., 11, 4-18 (1982).

48. Tomida, H. and Schwartz, M.A., "Further Studies on the Catalysis of Hydrolysis and Aminolysis of Benzylpenicillin by Metal Chelates", J. Pharm. Sci., 72, 331 (1983).

49. Schwartz, M.A., "Postdoctoral Education for Pharmacy Practice Faculty", Drug Intel. and Clin. Pharm., 18, 327 (1984).

50. Schwartz, M.A., "Chair Report for the Professional Affairs Committee", Am. J. Pharm. Educ., 48, 425-8 (1984).

51. Schwartz, M.A. and Ray, M.D., "College of Pharmacy - Teaching Hospital Relationships", Report of a Survey, Am. J. Hosp. Pharm., 42, 803-16 (1985).

8 52. Tomida, H., Kohashi, K., Tsuruta, Y., Kiryu, S., Schwartz, M. A., "Kinetics and Mechanism of Zinc Ion Mediated Degradation of Cephalosporins in Tromethamine Solution", Pharmaceutical Research, 4(3) (1987).

53. Schwartz, M.A. "Are Academic Pharmacists Meeting the Clinical Scientist Role?", Drug Intel. and Clin Pharm., 21, 114-117 (1987).

54. Schwartz, M.A., "Managing Potential Conflicts of Interest in University-Industrial Relationships", Pharmaceutical Research, 4(2) (1987).

55. Schwartz, M.A., "The Role of Pharmacy in Drug Development", Clinical Research Practices and Drug Regulatory Affairs, 5(5&6) (1987).

56. Schwartz, M.A., "A Strategic Plan For Pharmacy's Future", Am. J. Pharm. Educ., 53(2), 152-156 (1989).

57. Schwartz, M.A., "Envisioning Pharmacy's Future -- A Further Commentary on Strategic Planning", Am. J. Pharm. Educ., 54(2), 167-174 (1990).

58. Chen, S., Yan, G., Schwartz, M. A., Perrin, J. H., and Schulman, S. G., "Penicillin- 2+ Enhanced Chemiluminescence of the Luminol-H2O2-Co System", J. Pharm. Sci., 80, 1017-19 (1991).

59. Schwartz, M. A., "On Fear, Vision and Power", editorial, Am. J. Hosp. Pharm. 49, 1401 (June) 1992

60. Schwartz, M. A., "Creating Our Own Future in Pharmacy", Florida Pharmacy Today 58, Jan, 1994

61. Schwartz, M. A. "Creating Pharmacy's Future", American Pharmacy, NS34, No. 10, 44, Oct. 1994

62. Schwartz, M. A. "Are Today's Pharmacy Students Ready for the Real World?” Florida Pharmacy Today, Vol. 60, No. 2, Mar/Apr 1996, p.18

63. Schwartz, M. A. "Restructuring the Academic Health Center for the Twenty-first Century", Am. J. Health-System Pharmacy 54, 1711 (1997)

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SIHONG SONG ______

Office Address Home Address Department of Pharmaceutics 3418 NW 67th Ave University of Florida College of Pharmacy Gainesville, FL 32653 Powell Gene Therapy Center, Genetics Institute P. O. Box 100494 Gainesville, FL 32610 Phone: (352) 392-5280 Fax: (352) 392-4447 e-mail: [email protected] ______

EDUCATION 1996-1999 Post Doctoral Associate in Gene Therapy, University of Florida, Gainesville, FL 1992-1996 Ph.D. in Animal Molecular and Cell Biology, University of Florida, Gainesville, FL

1985-1989 M.S. in Animal Science, Jilin Agricultural University, Changchun, P.R. China

1978-1982 B.S. in Animal Science, Jilin Agricultural University, Changchun, P.R. China

PROFESSIONAL EXPERIENCE 2006.7-present Associate Professor Department of Pharmaceutics, University of Florida College of Pharmacy 2001.8-2006.6 Assistant Professor Department of Pharmaceutics, University of Florida College of Pharmacy 1999-2001.7 Research Assistant Professor Department of Pediatrics, Powell Gene Therapy Center, University of Florida 1996-1999 Post Doctoral Associate Department of Molecular Genetics and Microbiology, University of Florida 1992-1996 Graduate Assistant Department of Dairy and Poultry Sciences, University of Florida. 1987-1991 Lecturer (Faculty) Jilin Agriculture University, China 1982-1986 Teaching and Research Assistant (Faculty) Department of Animal Science, Jilin Agricultural University, China.

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TEACHING EXPERINCE Pharmaceutical Gene Delivery, Coordinator (PHA 6183), 2005 spring and 2007 spring, University of Florida Clinical Biochemistry Coordinator (PHA 5451), 2007 fall, University of Florida Clinical Biochemistry (PHA 5451), 2003 fall -2006 fall, University of Florida Clinical Biochemistry (PHA 5933), 2002 fall, University of Florida Graduate Seminar (Coordinator), 2002 fall, University of Florida Paper Discussion (GMS 6002), 2000 spring Animal Nutrition, 1987-1990, Jilin Agricultural University Animal Production, 1982-1986, Jilin Agricultural University

SUPERVISED STUDENTS AND POST DOCTORAL ASSOCIATES Ph.D. Students: 1. Mei Tang, Ph. D. student (Adviser, August 2002-August 2006) “Alpha 1 antitrypsin gene therapy and its immunoregulatory function for preventing type 1 diabetes in non-obese diabetic mouse”. Winner of poster competition: 17th Annual Research Showcase of College of Pharmacy, University of Florida, April 15, 2004. 2. Hong Li, Ph. D. student (Adviser, August 2004-present) “Adult stem cell based gene therapy for alpha 1 antitrypsin deficiency” 3. Christian Grimstein, Ph. D. student (Adviser, January 2005-present) “Gene therapy for arthritis”

Winner of senior oral competition: 21st Annual Research Showcase of College of Pharmacy, University of Florida, Feb 21, 2008 4. Matthias Futh, Ph. D. student (Adviser, August 2007-Present) “Stem cell mediated gene correction therapy” Postdoctoral Associates: 1. Yuanqing Lu, M.D., Postdoc (Adviser, November 2002-present) “Prevention of type 1 diabetes and stem cell biology”. 2. Young-Kook Choi, Ph. D., Postdoc, (Adviser, April 2003-Decmber 2007) “AAV vector Biology and gene therapy”. 3. Bin Zhang, Ph. D. (Adviser. May 2004- present) “Islet Biology and AAT gene expression and regulation” Visiting Professor: Hongxia Ma, Ph. D. (Associate professor in Pharmacology from Jilin Agricultural University, Changchun, China, August 2007-present) “Effect of hAAT on islet cell gene expression and

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Prevention of T1D using Tet-On-hAAT system” Pharm.D. Students: 1. Keith Lowe, 2PD student, recipient of 2003-2004 Merck Research Scholar Program Award (Adviser, May 2003-August 2004) “Construction and In Vitro Evaluation of a Noval AAV vector for Type 1 Diabetes Mellitus”. 2. Yitsung Wang, 1PD student, recipient of a NIH fellowship award (NIH T35-HL07489, Adviser, May 2005-Aggust 2005) “Construction and Evaluation of Regulatable Gene Therapy for Type I Diabetes” German Exchange Students: 1. Andreas Niclas Foerster (March – Sep. 2002) “Infection of five serotype of AAV vector to culture cells”. 2. Vera Wallmeier (April – Oct. 2002) “estimation of efficiency of rAAV integration in vitro” 3. Thomas Gardemann (January 2003-July 2003) “In vitro and in vivo detection of elafin and construction of dsAAV vector”. 4. Holger Piekuth (May 1, 2003-October 31, 2003) “Construction of dsAAV vectors”. 5. Katharina Manzer (May 1, 2003-October 31, 2003) “Construction of dsAAV vectors”. 6. Christian Grimstein (May 12, 2004-October 12, 2004) “Construction of scAAV vectors”. 7. Miriam Siemer (November 14, 2005 – May 14, 2006) “Development of rAAV vectors for dynorphin gene delivery” 8. Kay Werner Klindwort (May 1, 2006-October 31,2006) “Dynorphin gene delivery” 9. Astrid Holzinger (November 2, 2006-present) “scAAV vectors for Dynorphin gene therapy” 10. Katharana Tomala (June 10, 2007- December 10, 2007) “Salivary delivery of rAAV5-DYN and rAAV5-CB-hAAT for pain relieve” 11. Benjamin Ma (January 14, 2008-present) 12. Anna Ullrich (January 14, 2008-present) IDP Rotation Students: 1. Yi Hua (Fall, 1998) "Construction and evaluation of rAAV vectors for regulated transgene expression". 2. Nikki Rhodin (Spring, 1999) "In vivo evaluations of regulated transgene (IL-4 and IL-10) expression in myoblast cells (C2C12)" 3. Thomas Conlon (1999-2001) "Liver-directed gene delivery for alpha-1-antitrypsin deficiency". Under graduate students: 1. Kevin Foust, (1999-2001) "Characterization and identification of the promoter of human translation elongation factor 1 2 (EF-1 2) gene for muscle-directed gene delivery". 2. Chris Porter, (2000-2001), "In vitro and in vivo analysis of GT-enhancer activities". 3. Xueying Wang (2007-present), recipients of University Scholar and HHMI Undergraduate Research Award “Alpha 1 antitrypsin gene therapy for the treatment of rheumatoid arthritis” 4. Chia-Wei Tsai (2006 fall-present) “Evaluation of mutant human alpha 1 antitrypsin (hAAT

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for their anti-enzymatic activities” High School Students: 1. Frankie Beauliey (June 11-July 29, 2006), Student Science Training Program at the University of Florida. Graduate Committees: Chairman: 1. Mei Tang, 2006 Ph. D., Department of Pharmaceutics, College of Pharmacy. 2. Hong Li, Ph. D. student, Department of Pharmaceutics. 3. Christian Grimstein, Ph. D. student, Department of Pharmaceutics. 4. Matthias Futh, Ph.D. student, Department of Pharmaceutics.

Member: 1. Yan Gong, 2004 Ph. D., Department of Pharmaceutics. 2. Hao Zhu, 2004 Ph. D., Department of Pharmaceutics. 3. Ke Ren, 2005 Ph. D. Student, Department of Pharmaceutics. 4. Gregory G. Simon, 2005 Ph. D., IDP program, College of Medicine. 5. R. Flecter Schwartz, 2005 M.S., College of Medicine 6. Todd Brusko, 2006 Ph. D., IDP program, College of Medicine. 7. Aaron Hirko, 2006 Ph. D., Department of Pharmaceutics. 8. Wouter Driessen, 2007 Ph.D., Department of Pharmaceutics. 9. Nathalie Toussaint, 2007 Ph. D., Department of Pharmaceutics. 10. Leah Villegas, 2007 Ph.D. student, Department of Pharmaceutics. 11. Yanfei Qi, Ph.D. student, Department of Pharmacodynamics. 12. VinayakShenoy, Ph.D. student, Department of Pharmacodynamics. 13. MyPhoung Le, Ph.D. student, Department of Pharmaceutics. 14. Patricio Tapia, 2007 Ph.D. student, Dept. of Civil & Coastal Engineering 15. Michael Weide, Ph.D. student, Department of Pharmaceutics. 16. Yao Sun, Ph.D. student, Dept. of Biomedical Engineering 17. Ruixin Jiang, Ph.D. student, Dept. of Biomedical Engineering

INVITED AND ORAL PRESENTATIONS: 1. Song S, “Adeno-associated virus (AAV) vector mediated gene delivery for alpha-1- antitrypsin deficiency”. January 28, 2000, Animal Molecular and Cell Biology Seminar Series, University of Florida 2. Song S, “Recombimant Adeno-Associated Virus (AAV) Vector for Gene Therapy”, National Advisory Board Meeting , Best Western Gateway Hotel, Gainesville, Sep. 29, 2001 3. Song S, “Effect of DNAA-PK on the molecular fate of the rAAV2 genome”, College of Medicine, May 1, 2002 4. Song S, “Gene Therapy for Type 1 Diabetes”, University of Florida, March 21, 2003.

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5. Song S, “Ex Vivo Gene Transfer and Transplantation of Liver Stem Cell for Alpha-1 Antitrypsin Deficiency”. Sixth Annual Meeting of American Society of Gene Therapy, Washington DC, May, 2003. 6. Song S, “Effect of DNA-PK on rAAV2 Persistence in Mouse Liver”. Sixth Annual Meeting of American Society of Gene Therapy, Washington DC, May, 2003. 7. Song S, “Recombinant Adeno-Associated Virus (rAAT) Vector Mediated Gene Delivery for Preventing Type I diabetes” October 8, 2003, Interdisciplinary Reproductive Biology Group Seminar, University of Florida. 8. Song S, “Effect of hepatocyte division on rAAV integration”. Xth Parvovirus Workshop, St. Petersburg, FL, September 11, 2004. 9. Song, S. “AAV mediated AAT gene therapy for autoimmune diabetes” XIth Parvovirus Workshop, Les Diablerats, Switzerland, August, 27-31, 2006 10. Song, S. “Alpha 1 Antitrypsin (AT) for the Prevention of Type 1 Diabetes”, 6th International Scientific Conference New Insights into the Biology of AAT: The Expanded Role of AAT in the Treatment of AAT Deficient Individuals and Other Diseases, Coral Gables, Florida, Feb 8-10, 2007. 11. Song, S. “Therapeutic Potential of Alpha 1 Antitrypsin (AAT) for Type 1 Diabetes and Rheumatoid Arthritis” August 31, 2007, Pharmacy Practice, University of Florida. 12. Song, S. “Differential immune responses to hAAT in animal models” September 19, 2007, Pulmonology, University of Florida. 13. Song, S. “The therapeutic potential of alpha 1 antitrypsin for autoimmune diseases”. October 5, 2007, Animal Molecular and Cell Biology Seminar Series, University of Florida.

FUNDING RECEIVED ONGOING: 1. NHLBI, R21 HL079132 (PI=Song) July 1, 2005-June 30, 2008. $363,750 “Gene Therapy for Correction of PiZ Mutation”.

2. NIDDK, 2-P01-DK05327-06 (PI of the P01=Flotte; PI of the project 2=Song) Sep 1, 2005-August 31, 2010. $6,689,938 “Recombinant AAV for correction of genetic abnormalities Project 2: Adult stem cell as a platform for liver gene therapy”

3. NIH R01 HL69877 (PI-Flotte; Co-Investigator=Song) April 1, 2003-March 31, 2007. $1,160,000 “Preclinical & Phase I/II Trials of AAV-AAT Vectors”

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4. UF-RGP opportunity fund (PI=Song) May 1, 2006-April 30, 2008 $74,117 “Alpha 1 antitrypsin for the treatment of rheumatoid arthritis” COMPLETED: 1. NIDDK R21 DK062652-01 (PI=Song) July 1, 2002-June 30, 2005. $290,000 “Anti-inflammatory Serpin (AAT and AAV) gene Transfer to Enhance Islet Transplantation”.

2. Juvenal Diabetes Research Foundation (PI=Song) July 1, 2002-July 1, 2005. $450,000 ($150,000/year, for 3 years) “Anti-inflammatory Serpin Gene Therapy for Preventing Type 1 Diabetes”

3. March of Dimes Birth Defects Foundation (PI=Laipis, Co-PI=Song) July 1, 2002-June 30, 1005 $84,745/year “Gene Therapy Approaches to the Treatment of Phenylketonuria (PKU): Prevention of Maternal PKU Syndrome with rAAV Vectors Expressing Phenylalanine Hydroxylase”

4. Young Investigator Fellowship Award from Alpha One Foundation (PI=Song). July, 2001-July, 2002. $50,000 “Adeno-Associated Virus (AAV) Vectors for Skeletal Muscle Mediated Gene Therapy for Alpha-1 Antitrypsin (AAT) Deficiency-Preclinical Study in Non-human Primates”.

5. 2001 Children’s miracle Network Fall Award (PI=Song) January, 2002- January, 2003. $20,000 (equipment only) “Alpha-1 Antitrypsin Gene Therapy for Juvenile Diabetes”.

6. 2002 University of Florida Research Opportunity Fund (PI=Song). May 1, 2002-April 30, 2003 $30,000 “Gene Therapy for Type 1 Diabetes”

7. The JDRF gene Therapy Center for Diabetes and Diabetic Complication at the University of Florida and University of Miami. May 1, 2002-May 1, 2003 $5,000 “A Pilot study for Diabetes”

8. Merck Research Scholar Program Award (PI-Song, recipient Keith Lowe) May 2003-July 2004 $5,500 “Construction and In Vitro Evaluation of a Noval AAV vector for Type 1 Diabetes Mellitus”

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9. NIH T35-HL07489, a fellowship award to Yitsung Wang (Advisor=Song), May 9, 2005 to August 5, 2005. $4,328 “Construction and evaluation of regulatable gene therapy for type 1 diabetes mellitus”

PATENT 1. Flotte, T.R., Song, S., Byrne, B., Morgan, M. Materials and Methods for Gene Therapy. U.S 6,641,606 B1. 2. Flotte, T.R., Song, S., Byrne, B., Morgan, M. rAAV Composition for Gene Therapy. U.S. SN 10/267,117. 3. Flotte, T.R., Song, S., Byrne, B., Morgan, M. Adeno-Associated Viral Vectors for the treatment and Prevention of Diabetes. U.S. SN 10/340,112. 4. Song, S., Flotte, T.R., Atkinson, M.A., Loiler, S. rAAV Vector-Based Composition and Methods for the Prevention and Treatment of Mammalian Diseases. U.S. SN 10/512,008. 5. Womer K. Song, S., Samulski, R.J., Flotte, T.R., Loiler, S., Li, C., Atkinson, M.A., Clare- Salzler, M. Method and Compositions for Expressing a Nucleic Acid in a Dendritic Cell. U.S. SN 10/427,165.

HONORS 1. 2005 Junior Faculty Research Award of Sigma Xi, The Scientific Research Society. 2. 1999 Young Investigator Fellowship Awards of the Alpha One Foundation.

MEMBERSHIPS 1. Member of the American Society of Gene Therapy (ASGT) 2. Member of the American Diabetes Association (ADA) 3. Member of Sigma Xi, The Scientific Research Society 4. Member of American Association of College of Pharmacy 5. Member of Gamma Sigma Delta, Honor Society of Agriculture 6. Member of American Association for the Advancement of Science

PUBLICATIONS (** trainees in Song’s lab, * Song as a corresponding author) Journal Articles: 1. Zbang, B.**, Lu, Y.**, Campbell-Thompson, M., Spencer, T., Wasserfall, C., Atkinson, M., Song, S.* (2007) Alpha 1 antitrypsin protects -cells from apoptosis. Diabetes, 2007 56:1316-1323.

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2. Brantly, M.L., Spencer, L.T., Humphries, M., Conlon, T.J., Spencer, C.T., Poirier, A., Song, S., Berns, K., Muzyczks, N Snyder R.O., Byrne, B.J., Flotte, T.R. (2006) Phase I Trial of Intramuscular Injection of a Recombinant Adeno-associated Virus Serotype 2 (rAAV2) Alpha-1 Antitrypsin (AAT) Vector in AAT-deficient Adults. Human Gene Therapy, 17(12):1177-1186. 3. Lu, Y.**, Tang, M.**, Wasserfall, C., Kou, Z., Campbell-Thompson, M., Gardemann, T.**, Crawford, J., Atkinson, M., and Song, S.* (2006) 1-antitrypsin gene therapy modulates cellular immunity and efficiently prevents type 1 diabetes in nonobese diabetic mice. Human Gene Therapy, 17 (6):625-634. 4. Lu, Y.**, Choi, Y-K.**, Campbell-Thompson, M., Li, C., Tang, Q., Crawford, J., Flotte, T. R. and Song, S.* (2006) Therapeutic level of functional human alpha 1 antitrypsin (hAAT) secreted from murine muscle transduced by adeno-associated virus (rAAV1) vector. Journal of Gene Medicine, 8:730-735. 5. Petrache, I., Fijalkowska, I., Zhen, L., Medler1, T.R., Brown, E., Cruz, P., Choe, K-H., Taraseviciene-Stewart, L., Scerbavicius, R., Shapiro, L., Zhang, B.**, Song, S., Hicklin, D., Voelkel, N.F., Flotte, T., and Tudert, R.M. (2006) A novel anti-apoptotic role for alpha 1 antitrypsin in the prevention of emphysema. Am J Respir Crit Care Med, 173:1222- 1228. 6. Kwak, I., Song, S., Blum, J.L. Simmen, R.C.M. and Simmen, F.A. (2005) Enhancer- and Silencer-like Sequences that Mediate Insulin-Like Growth Factor-Binding Protein-2 Gene Expression in Uterine Cells of Pregnancy. DNA and Cell Biology 25(1):6-18.

7. Burkhardt, B.R., Parker, M.J., Zhang, Y.C., Song, S., Wasserfall, C.H., Atkinson, M.A. (2005) Glucose transporter-2 (GLUT2) promoter mediated transgenic insulin production reduces hyperglycemia in diabetic mice. FEBS Letters 579:5759-5764 8. Conlon, T., Cossette, T., Erger, K., Choi, Y-K.**, Clarke, T., Scott-Jorgensen, M., Song, S., Campbell-Thomson, M., Crawford, J. and Flotte T. (2005) Efficient Hepatic Delivery and expression from a recombinant adeno-associated virus 8 (rAAV8) pseudotyped alpha-1 antitrypsin vector. Molecular Therapy, 12 (5):867-875 9. Virella-Lowell, I., Zusman, B., Forst, K., Loiler, S., Conlon, T., Song, S., Chesnut, K. A., Ferkol, T., Flotte, T. R. (2005) Enhancing rAAV vector expression in the lung. J Gene Med. 7:842-850 10. Song, S.*, Witek, R. P., Lu, Y**., Choi, Y-K.**, Zheng, D., Jorgensen, M., Li, C., Flotte, T. R., Petersen, B. E. Ex vivo transduced liver stem cells as a platform for gene therapy. Hepatology, 40:918-924. 11. Poirier, A., Campbell-Thompson, M, Tang, Q., Scott-Jorgensen, M., Combee, L, Loiler, S., Crawford, J., Song, S., Flotte, T.R. (2004) Toxicology and Biodistribution Studies of a Recombinant Adeno-associated virus 2 (rAAV2)-Alpha-1 Antitrypsin (AAT) Vector. Preclinica, 2(1): 43-51.

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12. Wei, F-S., Song, S., Zhao, G.**, Lu, Y.**, Li, C., Wei, J-F. And Flotte, T.R. (2004) Stable transduction of murine embryonic stem (ES) cells with recombinant adeno-associated viruse serotype 2 (AAV2) vectors. Preclinica 2(4). 13. Song, S.*, K Goudy, M Campbell-Thompson, C Wasserfall, M Scott-Jorgensen, J Wang, Q Tang, JM Crawford, TM Ellis, MA Atkinson, and TR Flotte. (2004) Recombinant adeno- associated virus (rAAV2) mediated alpha-1 antitrypsin gene therapy prevents type 1 diabetes in NOD mice. Gene Therapy, 11: 181-186. 14. Song, S.*, Lu, Y.**, Choi, Y.**, Han, Y-K., Tang, Q., Zhao, G.**, Berns, KI and Flotte, T.R. (2004) DNA dependent Protein Kinase (DNA-PK) inhibits adeno-associated virus (AAV) integration. ). Proc. Natl. Acad. Sci. USA. 101(7): 2112-2116. 15. Zhang, Y.C., Powers, M., Wasserfall, C., Brusko, T., Song, S., Flotte, T.R., Snyder, R.O., Potter, M., Scott-Jorgensen, M., Campbell-Thompson, M., Crawford, J.M., Nick, H.S., Agarwal, A., Ellis, T.M., and Atkinson, M.A. (2004) Immunity to adeno-associated virus serotype 2 delivered transgenes imparted by genetic predisposition to autoimmunity. Gene Therapy. 11:233-240 16. Loiler, S.A., Conlon, C.J., Song, S., Tang, Q., Warrington, K.H., Agarwal,A., Kapturczak, M., Li, C., Ricordi, C., Atkinson, M.A., Muzyczka, N., Flotte, T.R. (2003) Targeting Recombinant Adeno-Associated Virus Vectors to Enhance Gene Transfer. Gene Therapy, 10:1551-1558. 17. Goudy, K., Burkhardt, B., Wasserfall, C., Song, S., Campbell-Thompson, M., Brusko, T., Powers, M., Clare-Salzler, M., Sobel, E., Ellis, T., Flotte, T.R., and Atkinson, M.A. (2003) Systemic Over Expression of IL-10 Induces CD4+ CD25+ Cell Populations In Vivo and Ameliorates Type 1 Diabetes in nonobese diabetic Mice in a Dose-Dependent Fashion. Journal of Immunology, 171:2270-2278. 18. Song, S., Scott-Jorgensen, M., Wang, J., Poirier, A., Crawford, J., Camphell-Thompson, M., Flotte, T.R., (2002) Recombinant adeno-associated virus 2-alpha 1-antitrypsin (rAAV- AAT) vectors in a non-human primate model: safety and immunologic aspects. . Molecular Therapy, 6(3):329-335 19. Mah, C., Fraites, T.J., Zolotukhin I., Song, S., Flotte, T.R., Batich, C., Byrne B.J. (2002) Improved method of recombinant AAV2 delivery for systemic targeted gene therapy. Molecular Therapy, 6(1):106-112. 20. Goudy, K., Song, S., Wasserfall, C., Zhang, Y.C., Kapturczak, M., Muir, A., Scott- Jorgensen, M., Campbell-Thompson, M., Crawford, J.M., Ellis, T.M., Flotte, T.R., and Atkinson, M.A. (2001) Adeno-associated virus vector-mediated IL-10 gene delivery prevents type 1 diabetes in NOD mice. Proc. Natl. Acad. Sci. USA. 98(24):13913-13918. 21. Song, S., Laipis, P.J., Berns, K.I., Flotte, T.R. (2001) Effect of DNA-PKcs on the molecular fate of the rAAV2 genome in skeletal muscle. Proc. Natl. Acad. Sci. USA. 98(7):4084- 4088.

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22. Song, S., Embury, J. Laipis, P.J., Berns, K.I., Crawford J.M., Flotte, T.R. (2001) Stable therapeutic serum levels of human alpha-1 antitrypsin (AAT)after portal vein injection of recombinant adeno-associated virus (rAAV) vectors. Gene Therapy, 8:1299-1306. 23. Flotte, T.R., Agarwal, A., Wang, J., Song, S., Fenjves, E.S., Inverardi, L., Chesnut, K., Fione, S., Loiler, S., Wasserfall, C., Kapturczak, M., Ellis, T., Nick, H., Atkinson, M. (2001) Efficient ex vivo transduction of pancreatic islet cell with recombinant adeno- associated virus vectors. Diabetes, 50:515-520. 24. Xu, L., Daly, T., Gao, C., Byrne, B.J., Flotte, T.R., Song, S., Sands, M.S., Ponder, K.P. (2001) The CMV- -actin promoter directed higher expression from an AAV vector in the liver than the CMV or EF1 promoter and results in therapeutic levels of human factor X in mice. Human Gene Therapy, 12:563-573. 25. Badinga, L., Song, S., Simmen, R.C.M., Clarke, J.B., Clemons, D.R., Simmen, F.A. (1999) Complex mediation of uterine endometrial epithelial cell growth by insulin-like growth factor-II (IGF-II) and IGF-binding protein-2. Journal of Molecular Endocrinology, 23:277-285. 26. Song, S., Morgan, M., Ellis, T., Poirier, A., Chesnut, K., Wang, J., Brantly, M., Byrne, B.J., Atkinson, M., Muzyczka, N., Flotte, T.R. (1998) Sustained secretion of human alpha-1- antitrypsin from murine muscle transduced with adeno-associated virus vectors. Proc. Natl. Acad. Sci. USA. 95(24):14384-14388. 27. Simmen, F.A., Badinga, L., Green, M.L., Kwak, I., Song, S. and Simmen, R.C.M. (1998) The Porcine IGF System: At the Interface of Nutrition, Growth and Reproduction. Journal of Nutrition, 128:315s-320s. 28. Badinga, L., Song, S., Simmen, R.C.M., Simmen, F.A. (1998) A distal regulatory region of the insulin-like growth factor binding protein-2 (IGFBP-2) gene interacts with the basic helix-loop-helix transcription factor, AP-4. Endocrine, 8(3):281-289. 29. Song, S., Lee, C.Y., Green, M.L., Chung, C.S., Simmen R.C.M., Simmen, F.A. (1996) The unique endometrial expression and genomic organization of the porcine IGFBP-2 Gene. Molecular and Cellular Endocrinology, 120:193-202. 30. Wang, C., Song, S., Bailey, L.B., Gregory, J. F. (1994) Relationship between urinary excretion of p-aminobezoylglutamate and folate status of growing rats. Nutrition Research, Vol. 14, pp. 875-884.

Abstracts: 1. Lu, Y., and Song, S. (2007) Differential immune responses to transgene productsfrom rAAV1 and rAAV8 vectors. Molecular Therapy, 15: s323. 2. Li, H., Lu, Y., Witek, R., Chang, L-J., Campbell-Thompson, M., Flotte, T., Petersen, B., and Song, S. (2007) Ex vivo transduction and transplantation of bone marrow cells for liver gene delivery of alpha 1 antitrypsin (AAT). Molecular Therapy, 15: s398.

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3. Flotte, T.R., Brantly, M.L., Spencer, L.T., Humphries, M., Conlon, T.J., Spencer, C.T., Poirier, A., Garlington, W., Baker, D., Song, S., Berns, K., Muzyczks, N Snyder R.O., Walsher, S., Byrne, B.J., (2007) Phase I clinical trials of intramuscular injection of rAAV2 and rAAV-pseudotyped versions of alpha-1 antitrypsin (AAT) vector in AAT-deficient adults. Molecular Therapy, 15:s402.

4. Choi, Y-K.**, Grimstein, C.**, Compbell-Thompson, M., Brantly, M., Spencer, T., and Song, S.* (2007) Effect of alpha 1 antitrypsin (AAT) on rheumatoid arthritis development in mouse model. Poster presentation in 6th International Scientific Conference New Insights into the Biology of AAT: The Expanded Role of AAT in the Treatment of AAT Deficient Individuals and Other Diseases, Coral Gables, Florida, Feb 8-10, 2007. 5. Zhang, B.**, Lu, Y**., Campbell-Thompson, M., Wasserfall, C., Atkinson, M. Brantly, M. and Song, S.* Alpha 1 antitrypsin protects against islet cell apoptosis and prevents diabetes. Poster presentation in 6th International Scientific Conference New Insights into the Biology of AAT: The Expanded Role of AAT in the Treatment of AAT Deficient Individuals and Other Diseases, Coral Gables, Florida, Feb 8-10, 2007. 6. Zhang, B.**, Tang, M..**, Wasserfall, C., Atkinson, M. Brantly, M. and Song, S.* Alpha 1 antitrypsin (AAT) inhibits Granzyme B activity and NK cell killing. Poster presentation in 6th International Scientific Conference New Insights into the Biology of AAT: The Expanded Role of AAT in the Treatment of AAT Deficient Individuals and Other Diseases, Coral Gables, Florida, Feb 8-10, 2007. 7. Song, S*, Lu, Y**., Tang, M.**, Zhang, B.**, Wasserfall, C., Campbell-Thompson, M., Atkinson, M. (2006) Alpha 1 Antitrypsin (AAT) Gene Therapy for the Prevention of Type 1 Diabetes. Molecular Therapy, 13: s30. 8. Glushakova, L.G., Gorbatuyk, M., Lu, Y.**, Song, S., Zheng, M., Shinohara, T., Hauswirth, W.W. (2006) Transfer of LEDGF to the Mouse Retina Via Systemic AAV Vector Administration. Molecular Therapy, 13: s192. 9. Brantly, M.L., Spencer, T., Spencer, C.T., Conlon, T.J., Song, S., Humphries, M., Byrne, B.J., Snyder, R.O., Flotte, T.R. (2006) Safety and Bioactivity of rAAV2-hAAT in alpha-1 Antitrypsin-Deficient Patients in a Phase I Clinical Trial. Molecular Therapy, 13: s281. 10. Zhang,, B.**, Lu, Y.**, Campbell-Thompson, M., Wasserfall, M., Atkinson, M. and Song, S.* (2006) Alpha 1 antitrypsin protects against islet cell apoptosis. Diabetes, 55 (supplement):A357. 11. Zhang, B.**, Compbell-Thompson, M., and Song, S.* (2006) Alpha 1 antitrypsin gene expression in islet cells. Diabetes, 55 (supplement):A357. 12. Choi, Y-K.**, Lu, Y.**, Song, S.* (2005) Effect of hepatocyte division on molecular fate of rAAV DNA. Molecular Therapy, 11(s1):s198. Poster presentation, 8th Annual Meeting of ASGT, St. Louis, June 1-5.

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13. Choi, Y-K.**, Zolotukin, I., Byrne, B. and Song, S.* (2005) Effect of DNA-PKcs rAAV repication. Molecular Therapy, 11(s1):s199Poster presentation, 8th Annual Meeting of ASGT, St. Louis, June 1-5. 14. Brantly, M. L., Humphries, M., Song, S., Conlon, T., Poirier, A., Byrne B. J., Snyder R., Flotte, T. R. (2005) Phase I clinical trials of recombinant adeno-associated virus (rAAV)- alpha-1 antitrypsin vectors. Molecular Therapy 11(s1):s415. Oral presentation, 8th Annual Meeting of ASGT, St. Louis, June 1-5, 2005. 15. Tang, M.**, Lu, Y.**, Brusko, T., Wasserfall, C., Zhang, B.**, Campbell-Thompson, M., Atkinson, M. and Song, S.* Prevention of type 1 diabetes by AAT gene therapy is dose and time dependent. Diabetes, 54(s1):A312. Poster presentation, 65th ADA annual meeting, San Diego, June 10-14, 2005. 16. Wasserfall, C., Schwartz, R., Simon, G., Annbinns, S., Brusko, T., Stalvey, M., Clare- Salzler, M., Song, S., Campbell-Thompson, M., Flotte, T., Atkinson, M. (2005) A dichotomous role for interleukin-10 in the pathogenesis of type 1 diabetes. Diabetes, 54(s1):A24. Oral presentation, 65th ADA annual meeting, San Diego, June 10-14, 2005. 17. Brantly, M.L., Hunphries, M., Song, S., Conlon, T., Poirier, A., Byrne, B.J., Snyder, R., and Flotte, T.R. (2005) Preclinical and Phase I/II clinical trails of recombinant adeno- associated virus (rAAV)-alpha-a antitrypsin vectors. Pediatric Academic Society Annual Meeting, May 14-17, 2005, Washington DC. 18. Lowe, K. C.**, Song, S. (2004) Construction and In Vitro Evaluation of a Novel AAV Vector for Type I Diabetes Mellitus. AACP annual meeting, Salt Lake City, UT, July 14, 2004. 19. Witek, R. P., Song, S., Lu, Y.**, Choi, Y-K.**, Zheng, D., Jorgensen, M., Li, C., Flotte, T. R., Petersen, B. E. (2004) Ex vivo transduced liver stem cells as a platform for gene therapy. FASEB Summer Research Conferences, Mechanisms of Liver Growth, Development and Disease. Snowmass Village, Colarado, August 7-12, 2004. 20. Brantly, M. L., Song, S., Humphries, M., Byrne B. J., Snyder R., Flotte, T. R. (2004) Preclinical and phase I/II clinical trials of recombinant adeno-associated virus (rAAV)- alpha-1 antitrypsin vectors. Xth Parvovirus Workshop, St. Petersburg, FL, September 11, 2004. 21. Choi, Y-K.**, Lu, Y.**, Song, S.* (2004) Effect of hepatocyte division on rAAV integration. Xth Parvovirus Workshop, St. Petersburg, FL, September 11, 2004. 22. Choi, Y-K.**, Lu, Y., Han, Y., Tang, Q., Zhao, G.**, Byrne, B. J., Berns, K. I., Flotte, T. R. Song, S.* (2004) Host cell effect on the molecular fate of rAAV genome. Xth Parvovirus Workshop, St. Petersburg, FL, September 11, 2004. 23. Song, S.*, Witek, R. P. Lu, Y.**, Choi, Y-K.**, Zheng, D., Jorgensen, M., Li, C., Flotte T. R. Petersen, B. E. (2004) Transplantation of ex vivo transduced liver progenitor cells by rAAV vector. Xth Parvovirus Workshop, St. Petersburg, FL, September 11, 2004.

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24. Lu, Y.**, Tang, M.**, Wasserfall, C., Choi1, Y-K.**, Gardmann, T., Campbell- Thompson, M., Atkinson, M. A., Song, S.* (2004) Prevention of Type 1 Diabetes by Alpha 1 Antitrypsin Gene Therapy. 2004 ADA annual meeting, June 4-8, Orlando. 25. Choi, Y-K.**, Barry J. Byrne, B. J., Song, S.* (2004) Targeting DNA-PK by siRNA to study AAV replication. 2004 ASGT annual meeting, June 2-6, Minneapolis. 26. Lu, Y.**, Tang, M.**, Wasserfall, C., Choi1, Y-K.**, Gardmann, T., Campbell- Thompson, M., Atkinson, M. A., Song, S.* (2004) Alpha 1 antitrypsin gene delivery for preventing type 1 diabetes in NOD mice. 2004 ASGT annual meeting, June 2-6, Minneapolis.. 27. Lu, Y.**, Compbell-Thompson, M., Li, C., Flotte, T.R., Song, S. (2004) Functional human alpha 1 antitrypsin secreted from muscle transduced by adeno-associated virus (rAAV1) vector. 2004 ASGT annual meeting, June 2-6, Minneapolis. 28. Song, S.*, Lu, Y.*, Choi, Y-K.**, Han, Y., Tang, Q., Zhao, G., Berns I.K., and Flotte, T.R., (2004) DNA Dependent Protein Kinase (DNA-PK) Inhibits Adeno-Associated Virus (AAV) DNA Integration. Gordon Conference, The Science of Viral Vectors for Gene Therapy, Santa Barbara, CA. Feb 8-13, 2004 29. Song, S.*, Zhao, G.**, Wu, K.**, Tang, Q. and Flotte, T.R. (2003) Molecular fate of rAAV2 genome in the liver of SCID and C57BL/6 mice. Poster presentation, American Society for Microbiology Conferences-Gene therapy: The Next Five Years, Banff, Canada (February 26- March 2, 2003). 30. Song, S.*, Zhao, G.**, Lu, Y.**, Tang, Q. and Flotte, T.R. (2003) Effect of DNA-PK on rAAV2 Persistence in Mouse Liver. Molecular Therapy 7 (5, part 2 of 2 parts): S106. 31. Song, S.*, Witek, R., Lu, Y., Petersen, B.E., Flotte, T.R. (2003) Ex Vivo Gene Transfer and Transplantation of Liver Stem Cell for Alpha-1 Antitrypsin Deficiency. Molecular Therapy 7 (5, part 2 of 2 parts): S13. 32. Song, S. *, and Zhou, G.**. (2003) Identification of promoters controlling alpha-1 antitrypsin gene expression in islet cells. Poster presentation, Air-2003, Barcelona, Spain. 33. Song, S.*, Witek, R., Lu, Y.**, Petersen, B.E., Flotte, T.R. (2003) Engineered Liver Stem Cell Transplantation for Alpha-1 Antitrypsin Deficiency. Poster presentation, Air-2003, Barcelona, Spain. 34. Wei, F., Song, S., Cruz, P., Lu, Y.**, Wei, J., Zhao, G., Flotte, T.R. (2003) Optimal Transductions of mouse Embryonic Stem Cells with recombinant AAV serotypes (1-5). Molecular Therapy 7 (5, part 2 of 2 parts): S34. 35. Chen, S., Kapturczak, M., Loiler, S.A., Song, S., Glushakova, O.Y., Li, C., Hauswirth, W.W., Berns, K.I., Madsen, K.M,, Samulski, R.J., Flotte, T.R., Atkinson, M.A., Tisher, C.C., Agarwal, A. (2003) Endothelial cell transduction with recombinant adeno-associated viral (AAV) serotypes: Implications for gene therapy in diabetic macrovascular complications. Abstract for 2003 American Diabetes Association Annual Meeting.

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36. Goudy, K., Burkhardt, B., Wasserfall, C., Sobel, E., Song, S., Ellis, T., Clare-Salzler, M., Flotte, T. and Atkinson, M. (2003) Immunomodulation of antigen presenting cells and induction of regulatory T cells prevents type I diabetes in NOD mice using AAV-IL10 gene therapy. Abstract for 2003 American Diabetes Association Annual Meeting. 37. Wei, F., Song, S., Loiler, S., Cruz, P., Conlon, T., Wei, J., Zhao, G., Flotte, T.R. (2003) Recombinant adeno-associated virus-mediated gene transfer for embryonic stem cell gene therapy. Pediatrics Research 53(4, part 2 of 2):256A 38. Song, S.*, Goudy, K., Compbell-Thompson, M., Wasserfall, Clive., Scott-Jorgensen M., Wang, J., Crawford, J.M., Atkinson, M.A., Flotte, T.R. (2002) Recombinant AAV mediated alpha-1 antitrypsin gene therapy prevents type 1 diabetes in NOD mice. Molecular Therapy, 5(5, part 2 of 2 parts):S342. 39. Wormer, K.L., Song, S., Loiler, S., Li, C., Atkinson, M.A., Flotte, T.R., Clare-Saltler, M. (2002) Murine Dendritic cells are transduced more efficiently by rAAV serotype 1 vectors compared with other serotypes. Molecular Therapy, 5(5, part2 of part2):S423. 40. Loiler, S., Song, S., Warrington, K.H., Agarwal A., Kapturczak, M., Li, C., Ricordi, C., Atkinson, M.A., Muzyczka,N., Flotte, T.R. (2002) Enhanced transduction of pancreatic islet cells with targeted recombinant adeno-associated virus vectors. Molecular Therapy, 5(5, part2 of part2):S429. 41. Goudy, K., Wasserfall, Clive., Burkhardt, B., Brusko, T., Song, S., Ellis, T., Flotte, T.R., Atkinson, M.A. (2002) Elucidation of time and dose dependencies using AAV-IL-10 gene therapy for prevetion of type 1 diabetes in the NOD mouse. Molecular Therapy, 5(5, part2 of part2):S17. 42. Goudy, K., Wasserfall, C., Burkhardt, B., Brusko, T., Song, S., Ellis, T., Flotte, T., Atkinson, M. Evaluation of Mechanism, Dose, and Time Dependency for AAV-IL-10 Gene Therapy in NOD Mice. Abstract for 2002 American Diabetes Association Annual Meeting. 43. Song, S.*, Flotte, T. R. (2001) Gene therapy for alpha-1 antitrypsin deficiency. First Siena International Conference on Animal Model of Chronic Obstructive Pulmonary Disease, Sep. 30-Oct. 2, 2001, Siena, Italy. 44. Gueerassimove, A., Song, S., Takubo, Y., Triantafillopoulos, A., Ghezzo, H., Flotte, T.R., and Cosio, M.G. (2001) Gene Transfer of alpha 1 antitrypsin in smoking pallid mice. First Siena International Conference on Animal Model of Chronic Obstructive Pulmonary Disease, Sep. 30-Oct. 2, 2001, Siena, Italy 45. Song, S. , Laipis, P. J., . Berns, K. I., Flotte, T. R. Effect of DNA-PK on the Molecular Fate of the rAAV2 Genome: A Possible Role in the Formation of Stable Circular Episomes and Protection Against Insertional Mutagenesis. Molecular Therapy, 3(5) S131, 2001. 46. Song, S., Goudy, K., Wasserfall, C., Wang, J., Ottendorfer, E., Ellis, T., Crawford, J. M., Atkinson, M. Flotte, T. R. Adeno-Associated Virus (AAV2) Vector Mediated IL-10 Gene Delivery Prevents Type I Diabetes in NOD Mice. Molecular Therapy, 3(5) S306, 2001.

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47. Loiler, S.A., Wang, J., Song, S., Atkinson, M, Flotte, T.R., Optimizing Promoter Expression and Transduction Efficiency of Human Islet Cells for the Treatment of Type I Diabetes. Molecular Therapy, 3(5) S179, 2001. 48. Wei, F., Song, S., Wei, J., Brannan, C.I. Flotte, T. R. Cloning and Seuence Analysis of Murine Genomic DNA Containing the DOM1 and DOM2 Alpha-1 proteinase Inhibitor (alpha-1 PI) Genes. Molecular Therapy, 3(5) S237, 2001. 49. Reyes, L., Alexander, J.J., Song, S., Steele, H.A., Berns, K.I., Chace, D.H., Flotte, T.R., Laipis, P.J. Effect of Sex Hormones on rAAV-Mediated Gene Trerapy in Female Phaenu2 Mice, an Animal Model for PKU. Molecular Therapy, 3(5) S232, 2001. 50. Laipis, P.J., Reyes, L., Embury, J.E., Alexander, J.J., Hurt, C.B., Wei, D.A., Song, S., Wang, J., Berns, K.I., Chace, D.H., Flotte, T.R. Long-term Reduction of Serum Phenylalanine Levels in a Mouse Model of PKU by rAAV-Mediated Gene Therapy. Molecular Therapy, 3(5) S293, 2001. 51. Guerassimov, A., Song, S., Takubo, Y., Triantafillopoulos, A., Ghezzo, H., Flotte, T.R. and Cosio, M.G. Gene Transfer of Alpha1-Antitrypsin in Smoking Pallid Mice. American Journal of Respiratory and Critical Care Medicine, 163(5), 2001 52. Goudy, K., Ellis, T., Ottendorfer, E., Song, S., Wasserfall, C., Flotte, T., Atkinson, M. Interleukin-10 Gene Therapy Utilizing Adeno-Associated Virus Vectors Prevents Type I Diabetes in NOD Mice. Diabetes, 50(supplement 2), 136-OR, 2001. 53. Song, S., Embury, J., Laipis, P., Conlon, T., Morgan, M., Wang, J., Berns, K., Flotte, T. (2000) Sustained therapeutic serum levels of human-1-antitrypsin (AAT) following a single portal vein injection of recombinant AAV. (Oral presentation) The Third Annual Meeting of the American Society of Gene Therapy, May 31 - June 4, 2000, Denver, Colorado. Molecular Therapy, 1(5) S133, 2000. 54. Virella-Lowell, I., Zusman, B., Conlon, T., Song, S., Morgan, M., Flotte, T. (2000) New Recombinant AAV Vectors for Improved Gene Expression in the Lung. (Oral presentation) The Third Annual Meeting of the American Society of Gene Therapy, May 31 - June 4, 2000, Denver, Colorado. Molecular Therapy, 1(5) S240, 2000. 55. Xu, L., Daly, T., Gao, C., Byrne, B.J., Flotte, T.R., Song, S., Sands, M.S., Ponder, K.P. (2000) Evaluation of Different Promoters in AAV Vectors and Therapeutic Levels of Expression of Human Factor X in Mice From an AAV with the CMV Enhancer –actin Promoter. The Third Annual Meeting of the American Society of Gene Therapy, May 31 - June 4, 2000 Denver, Colorado. Molecular Therapy, 1(5) S289, 2000. 56. Song, S., Embury, J., Laipis, P.J., Conlon, T.J., Morgan, M., Wang, J., Berns, K.I., Flotte, T.R. Therapeutic level of human alpha-1-antitrypsin secreted from murine liver transduced with recombinant adeno-associated virus (rAAV) vectors. 2000 International Conference, May 5-10, Toronto, Canada. American Journal of Respiratory and Critical Care Medicine 161 (3), A285.

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57. Virella-Lowell, I. Zusman, B., Conlon, T., Song, S., Morgan, M., Flotte, T. (2000) A CMV/beta actin hybrid promoter improves rAAV vector expression in vitro and in vivo. 2000 International Conference, May 5-10, Toronto, Canada. American Journal of Respiratory and Critical Care Medicine 161 (3), A287. 58. Virella-Lowell, I., Song, S., Morgan, M., Flotte, T.R. (1999) A cmv/beta actin hybrid promoter greatly improves recombinant adeno-associated virus (rAAV) vector expression in the murine lung. Thirteenth Annual North American Cystic Fibrosis Conference, October 7-10, 1999, Seattle, Washington. Pediatric Pulmonology, Supplement 19, September 1999. 59. Song, S., Wang, J., Morgan, M., Rhodin, N., Ellis, T., Flotte, T., Atkinson, M. (1999) Regulated high-level expression of cytokines interleukin-4 (IL-4) and IL-10 from murine muscle transduced with recombinant adeno-associated virus (rAAV) vectors. 4th Immunology of Diabetes Society Congress, Nov. 13-15, 1999, Roma, Italy 60. Song S., Wang, J., Morgan, M., Flotte, T.R. (1999) Analysis of integrated and episomal forms of recombinant AAV in murine skeletal muscle. Oral presentation, 2nd Annual Meeting of the American Society of Gene Therapy in Washington, DC, June 9-13, 1999. 61. Song, S., Morgan, M., Ellis, T., Poirier, A., Chesnut, K., Wang, J., Brantly, M., Byrne, B.J., Atkinson, M., Flotte, T.R. (1998) Sustained secretion of therapeutic level of human alpha- 1-antitrypsin from murine muscle transduced with adeno-associated virus vectors. Fourth Cold Spring Harbor Meeting on Gene Therapy, Sep 23-27, 1998. 62. Song, S., Morgan, M., Ellis, T., Poirier, A., Chesnut, K., Wang, J., Brantly, M., Byrne, B.J., Atkinson, M. Flotte, T.R. (1998) Sustained secretion of human alpha-1-antitrypsin from murine muscle transduced with adeno-associated virus vectors. Program & Abstracts of the first Annual Meeting of American Society of Gene Therapy (Seattle, Washington) p.49a. 63. Song, S., Wang, J., Chesnut, K., Morgan, M., Byrne, B. J., Flotte, T.R. (1998) Adeno- associated virus (AAV) vector for gene therapy of alpha-1-antitrypsin (AAT) deficiency. 1998 International Conference (Chicago, Illinois), American Journal of Respiratory and Critical Care Medicine 157, p.A565. 64. Kwak, I, Song, S., Badinga, L., Simmen, R.C.M., Simmen, F.A. (1998) Tanscriptional motifs of the insulin-like growth factor-binding protein-2 (IGFBP-2) gene in endometrium. Program & Abstracts of the 80th Annual Meeting of The Endocrine Society (New Orleans, Louisiana). 65. Badinga, L., Song, S., Yang, J., Collante, W. R., Simmen, R.C.M., Simmen, F.A. (1997) Recombinant porcine insulin-like growth factor-binding protein-2 (IGFBP-2) interacts with human insulin-like growth factor-2 (IGF-II) to modulate human and porcine uterine epithelial cell proliferation. Biology of Reproduction (supplement), 156:104.

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66. Song, S., Simmen, R.C.M., Simmen, F.A. (1995) Identification of 5' flanking DNA sequences that mediate endometrial expression of the Insulin-Like Growth Factor-Binding Protein-2 (IGFBP-2) gene. In Proceedings of the 77th Annual Meeting of the Endocrine Society (Washington, D. C.), P.165. 67. Song, S., Lee, C.Y., Collante, W., Chung, C.S., Simmen, F.A. (1994) Endometrial expression, chromosomal organization and potential 5'-regulatory sequences of the porcine Insulin-Like Growth Factor-Binding Protein-2 gene. In Proceedings of the 76th Annual Meeting of the Endocrine Society (Anaheim, CA) p. 438. 68. Wang, C., Song, S., Bailey, L.B., Gregory, J.F. (1992) Relationship between urinary excretion of p-aminobenzoylglutamate (pABG) and folate status of growing rats. Presentation at the 1992 meeting of the Federation of American Societies for Experimental Biology, Anaheim, CA. FASEB Journal 6:A1499. Invited or Non-peer reviewed articles: 1. Song, S. (2004) Book Review of “Generation of cDNA Libraries. Methods and Protocols” Pharmaceutical Research, 21 (3):545 Dissertation and Thesis: 1. Sihong Song. (1996) Structural and Functional Analysis of the Endometrial Gene Encoding Insulin-like Growth Factor-Binding Protein-2. Ph.D. Dissertation, University of Florida.

2. Sihong Song. (1989) Strategy for developing animal husbandry in Daqing City. M. S. Thesis, Jilin Agricultural University, Changchun, China.

17 Curriculum Vitae

Reginald F. Frye

March 2008

Office Address: University of Florida College of Pharmacy Department of Pharmacy Practice PO Box 100486, HSC Gainesville, FL 32610 Phone: (352) 273-5453 Fax: (352) 273-6121 Email: [email protected]

EDUCATION

1995 University of Pittsburgh Ph.D., Clinical Pharmaceutical Science 1990 Mercer University Pharm.D, Doctor of Pharmacy 1986 Oglethorpe University B.S., Biology

APPOINTMENTS AND POSITIONS 2003-present Associate Professor, Departments of Pharmacy Practice and Pharmaceutics; Associate Director, Center for Pharmacogenomics; Graduate Coordinator, Department of Pharmacy Practice, College of Pharmacy, University of Florida (tenure awarded July 2004). 2002-2003 Associate Professor with tenure, Department of Pharmaceutical Sciences, School of Pharmacy, and Member, Center for Clinical Pharmacology, School of Medicine, University of Pittsburgh. 2001-2003 Associate Member, Center for Pharmacogenetics, School of Pharmacy, University of Pittsburgh. 1998-2003 Director, Clinical Pharmacology Analytical Facility, Center for Clinical Pharmacology, School of Medicine, University of Pittsburgh 1995-2002 Assistant Professor, Department of Pharmaceutical Sciences, School of Pharmacy, and Member, Center for Clinical Pharmacology, School of Medicine, University of Pittsburgh. 1993-1996 Staff Pharmacist, Veterans Administration Medical Center, Pittsburgh, PA. 1991-1995 Graduate Student, Department of Pharmacy and Therapeutics, School of Pharmacy, and Member, Center for Clinical Pharmacology, School of Medicine, University of Pittsburgh. 1991-1993 ASHP Fellow in Clinical Pharmacokinetics, Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh. 1990-1991 Clinical Pharmacokinetics Fellow and Clinical Instructor, School of Pharmacy, University of North Carolina, Chapel Hill, NC. Preceptors: Gary R. Matzke, Pharm.D., Stanley W. Carson, Pharm.D.

CV – Reginald F. Frye, Jr. Page 2

PHARMACY LICENSURE 1990 North Carolina, #10912

HONORS AND AWARDS 1986-1990 Mercer University Dean's List 1987 M.A. Chambers Award for Academic Achievement 1988 Outstanding Young Men of America 1988 Rho Chi Honor Society 1989 Mercer University Dean's Merit Scholarship 1989 Phi Kappa Phi National Honor Society 1990 Hoechst-Roussel Excellence in Clinical Pharmacy Award 1990 Summa Cum Laude graduate, Mercer University 1991-1993 American Society of Hospital Pharmacists Research and Education Foundation Fellowship in Clinical Pharmacokinetics 1991-1993 1992 Gordon Research Conferences Graduate Student Travel Award 2000 University of Pittsburgh Senior Vice Chancellor’s Research Seminar Series Presenter

MEMBERSHIPS IN PROFESSIONAL AND SCIENTIFIC SOCIETIES American Association of Colleges of Pharmacy, 1995- American Association of Pharmaceutical Scientists, 1991- American College of Clinical Pharmacy, 1990- American College of Clinical Pharmacology, 2003- American Society for Clinical Pharmacology and Therapeutics, 1997- American Society of Health System Pharmacists, (1986-1997) International Society for the Study of Xenobiotics, 1992-

TEACHING RESPONSIBILITIES

UNIVERSITY OF FLORIDA, 2003 – present Appointed to Graduate Faculty November 2003 College of Pharmacy: Professional PHA5782 2003 - Pharmacotherapy II (drug dosing in renal disease, pharmacokinetics of cardiovascular drugs, and drug interactions; 6 lecture hrs) PHA5783 2004 - Pharmacotherapy III (clinical pharmacokinetics of anti-epileptic and anti- infective drugs; 5 lecture hrs) PHA5121 2004 - Advanced Clinical Pharmacokinetics (2-4 lecture hrs) PHA5113 2004 - Drug therapy Monitoring and Pharmacogenomics (Course coordinator, 12-16 lecture hours). Graduate PHA6427 2005 - Pharmacogenetics of Drug Metabolism and Transport (Course director)

CV – Reginald F. Frye, Jr. Page 3

UNIVERSITY OF PITTSBURGH, 1995 – 2003 School of Pharmacy: Professional Pharm 3407 1993 - 1998 Clinical Pharmacokinetics (Lecturer in Population & Bayesian Pharmacokinetics, Computer applications, Theophylline, Phenytoin; 20 contact hrs) Pharm 3402 1997 Pharmacokinetic Concepts (Course Coordinator 1997, 10 contact hrs) Pharm 3002 1995 – 2003 Advanced Pharmacokinetics (Lecturer; 14-22 contact hrs) Pharm 1790 1995 – 2003 Undergraduate Research Pharm 5218 1998 – 2003 Drug Development 2 (Pharmacokinetics/Drug Metabolism Course for PharmD students; Course Coordinator 1998-2001; 18-24 lecture hrs) Graduate Pharm 3102 1995 – 2001 Drug metabolism (Course Coordinator; 6 contact hrs) Pharm 3027 1997 – 2003 Topics in Biopharmaceutics/Pharmacokinetics Pharm 3020 2002 – 2003 Pharmacogenomics (Course Coordinator; 17 contact hrs) Pharm 3021 2002 – 2003 Topics in Pharmacogenomics (Course Coordinator; 14 contact hrs)

School of Medicine (1996 to 1998, 2001) Med 5710 1996 – 1998 Selective Course in Clinical Pharmacology (Lecturer in Pharmacokinetic Concepts for Clinicians, Pharmacokinetics workshop, Drug removal during continuous dialytic procedures; 5 contact hrs) Med 5710 2001 Selective Course in Clinical Pharmacology (Facilitator in Pharmacokinetic Concepts for Clinicians; 3 contact hrs)

UNIVERSITY OF NORTH CAROLINA, 1991: Pharm.D. Curriculum PhPr 139 Computer Applications in Clinical Pharmacokinetics (DrugCalc, Phenytoin) Undergraduate PhPr 77 Pharmacotherapeutics (Chronic Renal Failure, Drug Dosing in Renal Failure)

EDUCATIONAL RESEARCH University of Florida Professional Pharmacy Students Melonie Potvin 2004 Dana Fishbain 2005 Fiadora Avramidis 2004 Jason Karnes 2006 Julio Duarte 2004 Tyler Barker 2006 Erika Diaz 2005 Jessica Enogieru 2007 Tanisha Cooper 2005 Stephen Harvey 2007 Matthew Soto 2005

University of Pittsburgh Undergraduate Students Michael Drummond 1996 Ivan Colaizzi 1999-2000 Graduate Students Aarti Ranade 2000 Matthew Hruska 2001 Mohammed Al-Dosary 2000 Gregor Bendor 2002

CV – Reginald F. Frye, Jr. Page 4

Professional Pharmacy Students Robert Berringer 1996 Bill Gentsch 2000 Jodie Campbell 1998 Shelby Corman 2001 Susan Byrne 1998 Sara Bristol 2001 Madelaine Betancourt 1999 Steven Ganchuk 2002 Thomas Nolin, M.S. 1999 Irina Sheyko 2002 Matthew Hruska 1999

UPMC Hospital Pharmacy Residents Patricia Pecora, PharmD 1995-6 Michael Shullo, PharmD 1997-8 Lisa (Dreger) Opatik, PharmD 1996-7 Laurel (Evers) Riemenn, PharmD 1998-9 Brian Kearney, PharmD 1997 Jackie Dix, PharmD 2002

GRADUATE RESEARCH University of Florida Member, Graduate Faculty 2003. Graduate Major Advisor Prajakta Dravid Graduated, M.S. degree December 2007 Department of Pharmaceutics Mohamed Eslam Mohamed Anticipated Graduation: 2009 Clinical Pharmaceutical Scientist Program Graduate Committee Member Immo Zdrojewski Anticipated Graduation: 2008 Department of Pharmaceutics Elvin D. Price, Pharm.D. Anticipated Graduation: 2009 Clinical Pharmaceutical Scientist Program Hrishikesh Navare Anticipated Graduation: 2009 Department of Pharmaceutics MyPhoung Le Anticipated Graduation: 2009 Department of Pharmaceutics

University of Pittsburgh Member, Graduate Faculty 1997. Graduate Major Advisor J. Ike Lee, Pharm.D. Graduated, Ph.D. degree April 2001 Clinical Pharmaceutical Scientist Program Khalid Alkharfy, Pharm.D. Graduated, Ph.D. degree July 2002 Clinical Pharmaceutical Scientist Program Thomas Nolin, M.S., Pharm.D. Graduated, Ph.D. degree May 2003 Clinical Pharmaceutical Scientist Program Sara Fitzgerald Graduated, M.S. degree April 2004 Genetic Counseling Program Matthew Hruska, Pharm.D. Graduated, Ph.D. degree October 2004 Clinical Pharmaceutical Scientist Program Rama Sivasubramanian, M.S. Graduated, Ph.D. degree November 2005 CV – Reginald F. Frye, Jr. Page 5

Department of Pharmaceutical Sciences

Graduate Committee Member Amy Pittenger, Pharm.D. Graduated, M.S. degree August 1996 Clinical Pharmaceutical Scientist Program Thomas Dowling, Pharm.D. Graduated, Ph.D. degree June 1999 Clinical Pharmaceutical Scientist Program Firoozeh S. Salek, Pharm.D. Graduated, Ph.D. degree July 1999 Clinical Pharmaceutical Scientist Program Fahd Al-Genoby, B.S. Graduated, Ph.D. degree December 2000 Department of Pharmaceutical Sciences Vinod Ramachandran, M.S. Graduated, Ph.D. degree January 2001 Department of Pharmaceutical Sciences Jaya Pisaputi, M.S. Graduated, Ph.D. degree August 2001 Department of Pharmaceutical Sciences Elsa Crick Graduated, M.S. degree April 2002 Graduate School of Public Health Vera Donnenberg, MS Graduated, Ph.D. degree July 2002 Department of Pharmaceutical Sciences Abdullah Al-Mohizea Graduated, Ph.D. degree: November 2002 Department of Pharmaceutical Sciences Matthew Hummel Graduated, M.S. degree: January 2003 West Virginia University Junhai Oo Graduated, M.S. degree: February 2003 Department of Pharmaceutical Sciences Christopher Bolcato Graduated, M.S. degree: June 2003 Department of Pharmaceutical Sciences Maggie Folan, RN, BSN Graduated, Ph.D. degree July 2003 Department of Pharmaceutical Sciences Bernard Komoroski Graduated, Ph.D. degree March 2005 Department of Pharmaceutical Sciences William Zamboni Graduated, Ph.D. degree May 2005 Department of Pharmaceutical Sciences Aarati Ranade Graduated, Ph.D. degree November 2005 Department of Pharmaceutical Sciences Comprehensive Examination Committee Member (Department of Pharmaceutical Sciences) Mohammed Al-Dosary January 2003 Gregor Bender March 2003

CV – Reginald F. Frye, Jr. Page 6

SERVICE University of Florida Health Science Center General Clinical Research Center Advisory Committee, 2005 – Advanced Post Graduate Program in Clinical Investigation Advisory Committee, 2007 – CTSA Training Core Committee, 2006 – 2007

College of Pharmacy Graduate Coordinator, Department of Pharmacy Practice, 2004 – Graduate Studies Committee, 2005 – Tenure and Promotion Committee, 2004 – 2006, 2006 – 2008 Equipment committee, 2003 – Department of Pharmacy Practice, Faculty search committee: 2004 search A (chair), 2004 search B (chair), 2005 Search (chair), 2007 Search (chair)

University of Pittsburgh University Departmental and Faculty Computing Working Group of the Executive Committee for Academic Computing, University of Pittsburgh, 1996 – 1999. Department of Anesthesiology and Critical Care Medicine, Manuscript Review Committee, 1996 University of Pittsburgh, Biomedical Institutional Review Board, 1998 – 2003. General Clinical Research Center Advisory Committee, 1999 – 2003. GCRC Education Committee, 2001 – 2003 University of Pittsburgh Cancer Institute, Clinical Pharmacology Core Internal Advisory Committee, 2002 - 2003 School of Pharmacy Department of Pharmacy and Therapeutics Faculty Search Committee: Cardiology 1997, MICU 1997, Internal medicine 1998-9, Internal Medicine 2000, Infectious Disease 2001-2. Department of Pharmaceutical Sciences Faculty Search Committee: Neuropsychiatry position 1998, Population pharmacokinetics position 2000. Code of Conduct Committee, School of Pharmacy, 1996 – 2000. Department of Pharmaceutical Sciences, Research Seminar Committee, 1997 – 2003. University of Pittsburgh Pharmacy Associates, Advisory Committee, 1998 – 2000. Graduate Committee, School of Pharmacy, 1998 – 2001. Department of Pharmaceutical Sciences, Graduate Program Council, 2002 – 2003. Other Interferon treatment and drug interactions – KQV radio

MANUSCRIPT REVIEWER American Journal of Health-Systems Pharmacy Human Genetics American Journal of Kidney Disease Journal of Antimicrobial Chemotherapy American Journal of Obstetrics and Gynecology Journal of Chromatography A American Journal of Pharmaceutical Education Journal of Chromatography B American Journal of Transplantation Journal of Clinical Pharmacology Annals of Pharmacotherapy Journal of Clinical Psychopharmacology Biological Psychiatry Journal of Pharmaceutical and Biomedical Analysis Biomedical Chromatography Journal of Pharmacology and Experimental Therapeutics CV – Reginald F. Frye, Jr. Page 7

British Journal of Clinical Pharmacology Journal of Pharmacy Technology Cancer Chemotherapy and Pharmacology Kidney International Clinical Pharmacology and Therapeutics Life Sciences Clinical Pharmacokinetics Open Drug Metabolism Journal Digestive Diseases and Sciences Pediatrics Drug Metabolism and Disposition Pharmaceutical Research European Journal of Clinical Pharmacology Pharmacogenetics and genomics Food and Chemical Toxicology Pharmacotherapy Gerontology Planta Medica

EDITORIAL BOARD MEMBER Pharmacotherapy, 2006 Open Drug Metabolism Journal, 2007

GRANT REVIEWER American College of Clinical Pharmacy Research Institute. Pharmacotherapy Review panel. 1998, 2002. PPP Foundation, London, England. Themed Grant: Older People Program. Pharmacogenetics/Drug Metabolism grant reviewer. January 2002. National Institute of Mental Health, Special Emphasis Panel (ZMH1-CRB-B-01), Research on the Mental Health of Minority Populations (Pharmacogenetics reviewer). December 2001. National Center for Complementary and Alternative Medicine, Special Emphasis Panel (ZAT1 CP-10), Cranberry: Urinary Tract Infection and Other Conditions. (Drug Metabolism / Drug Interaction reviewer). September 2003. National Institutes of Health, Center for Scientific Review Special Emphasis Panel (ZRG1 RPHB-B (05): Cancer Treatment), Ad hoc reviewer. November 2004. National Institutes of Health, Center for Scientific Review Special Emphasis Panel (ZRG1 RPHB-B (05) and ZRG1 RPHB-J (02)), Ad hoc reviewer. July 2005.

OTHER PROFESSIONAL ACTIVITIES American Association of Pharmaceutical Scientists (AAPS) Abstract Reviewer, Annual Meeting, 1996, 1997 Abstract Screening Committee, Clinical Science Section Chair, 1997 Clinical Science Research Achievement Award Selection Committee, 1997 Hot Topics Committee, 2004 Annual Meeting American College of Clinical Pharmacy (ACCP) Abstract Reviewer, Annual and/or Spring Meetings, 1997 – present American Society for Clinical Pharmacology and Therapeutics (ASCPT) Abstract Reviewer, Annual Meeting, pharmacokinetics/drug metabolism section 1999 – present Membership Committee, 2001 – 2004 Vice Chair, Pharmacokinetics and Drug Metabolism section, 2006 – present

CV – Reginald F. Frye, Jr. Page 8

CONSULTING ACTIVITIES Abbott Laboratories, Pharmacokinetics/drug metabolism consultant, 1996-8 Baxter Pharmaceutical Products, (formerly Ohmeda, Inc.), Pharmacokinetics consultant, 1993- 2001 Bayer Corporation, drug metabolism/drug interaction consultant, 2004 Otsuka America Pharmaceutical, Inc., Pharmacokinetics/drug metabolism/bioanalytics consultant, 1995-9. PharmaSolutions, consultant, drug interactions, 2004

PUBLICATIONS BOOK CHAPTERS: 1. Matzke GR, Luke DR, Frye RF, Dupuis RE. Dialysis and Renal Transplantation. In: Herfindal ET, Gourley DR, Hart LL (eds.). Clinical Pharmacy and Therapeutics. Fifth Edition. Baltimore, MD: William and Wilkins, 1992:372-392. 2. Matzke GR, Frye RF. Drug dosing in renal failure. In: Posey LM, DiPiro J, Talbert R, Hayes P, Yee G, Matzke GR (eds.). Pharmacotherapy: A Pathophysiologic Approach. Second Edition. Amsterdam: Elsevier Science Publishers B.V., 1992:750-763. 3. Frye RF, Matzke GR. Vancomycin. In: Murphy JE (ed.). Clinical Pharmacokinetics Pocket Reference. American Society of Hospital Pharmacists' Special Projects Division, 1993:281-291. 4. Matzke GR, Frye RF: Drug therapy individualization for patients with renal insufficiency. In: Pharmacotherapy: A Pathophysiologic Approach, Third Edition. DiPiro J, Talbert R, Yee G, Matzke GR, Wells B, Posey LM, (eds). Appleton Lange: Norwalk, CT, 1996. 5. Frye RF, Matzke GR: Drug therapy individualization for patients with renal insufficiency. In: Pharmacotherapy: A Pathophysiologic Approach, Fourth Edition. DiPiro J, Talbert R, Yee G, Matzke GR, Wells B, Posey LM, (eds). Appleton Lange: Norwalk, CT, 1999. 6. Frye RF, Matzke GR. Vancomycin. In: Murphy JE (ed.). Clinical Pharmacokinetics Pocket Reference. Second edition. American Society of Health-System Pharmacists' Special Publishing, 2001:375-87. 7. Frye RF, Matzke GR: Drug therapy individualization for patients with renal insufficiency. In: Pharmacotherapy: A Pathophysiologic Approach, Fifth Edition. DiPiro J, Talbert R, Yee G, Matzke GR, Wells B, Posey LM, (eds). Appleton Lange: Norwalk, CT, 2002. 8. Frye RF, Capitano B, Matzke GR. Vancomycin. In: Murphy JE (ed.). Clinical Pharmacokinetics Pocket Reference. Third edition. American Society of Health-System Pharmacists' Special Publishing, 2005; 349- 64. 9. Frye RF. Pharmacogenetics of oxidative drug metabolism and its clinical application. Pharmacogenomics: Applications to Patient Care. American College of Clinical Pharmacy, Kansas City, MO. 2004; 273-307. 10. Nolin TD, Frye RF. Potential Role of Pharmacogenetics in Improving Medication Adherence. In: Methodological Issues in the Study of Adherence. Dunbar-Jacob J, Erlen J, Schlenk E, and Stilley C, (eds). University of Pittsburgh Press, Pittsburgh, PA, 2005; 121-33. 11. Frye RF, Matzke GR: Drug therapy individualization for patients with renal insufficiency. In: Pharmacotherapy: A Pathophysiologic Approach, Sixth Edition. DiPiro J, Talbert R, Yee G, Matzke GR, Wells B, Posey LM, (eds). Appleton Lange: Norwalk, CT, 2005; 919-35. 12. Capitano B, Frye RF, Matzke GR. Vancomycin. In: Murphy JE (ed.). Clinical Pharmacokinetics Pocket Reference. Fourth edition. American Society of Health-System Pharmacists' Special Publishing, 2007; Chapter 20, pages 329-344. CV – Reginald F. Frye, Jr. Page 9

13. Matzke GR, Frye RF: Drug therapy individualization for patients with renal insufficiency. In: Pharmacotherapy: A Pathophysiologic Approach, Seventh Edition. DiPiro J, Talbert R, Yee G, Matzke GR, Wells B, Posey LM, (eds). Appleton Lange: Norwalk, CT, 2008; in press.

LETTERS, CASE REPORTS: 1. Marshall LL, Frye RF, Murphy JE. Students' experience in a phase III clinical trial. Am J Hosp Pharm 1990; 47:1014-6. 2. Frye RF, Matzke GR. Book review: Infectious Diseases: Prophylaxis & Chemotherapy. Am J Hosp Pharm 1991; 48:843-7. 3. Frye RF, Job ML, Dretler RH, Rosenbaum BJ. Teicoplanin Nephrotoxicity: First Case Report. Pharmacotherapy 1992;12(3):240-242. 4. Gleason PP, Frye RF, O’toole T. Debilitating Reaction Following the Initial Dose of Tramadol. Ann Pharmacother 1997;31:1150-2.

PEER REVIEWED ARTICLES – REVIEW PAPERS: * = individuals in training are indicated by an asterisk 1. Matzke GR, Frye RF. Drug administration in patients with renal insufficiency: Minimizing renal and extrarenal toxicity. Drug Safety 1997;16(3):205-231. 2. Kroboth PD, *Salek FS, *Pittenger AL, *Fabian TJ, Frye RF. DHEA and DHEA-S: A Review. J Clin Pharmacol 1999; 39(4):327-48. 3. *Nolin TD, Frye RF, Matzke GR. Hepatic Drug Metabolism and Transport in Patients with Kidney Disease. Amer J Kid Dis 2003; 42(5):906-925. 4. Frye RF. Probing the World of Cytochrome P450 Enzymes. Mol Interv. 2004 Jun;4(3):157-62.

PEER REVIEWED ARTICLES – ORIGINAL RESEARCH: * = Trainees working under my direction are indicated by an asterisk 1. Stiff DD, Frye RF, Branch RA. Sensitive high-performance liquid chromatographic determination of chlorzoxazone and 6-hydroxychlorzoxazone in plasma. J Chromatogr Biomed Appl 1993;613:127-131. 2. Kisor DF, Frye RF, Kudsk KA. Estimation of the hepatic extraction ratio of indocyanine green in swine. Clin Sci 1993;84:681-685. 3. Carcillo J, Romkes-Sparks M, Parise RA, Adedoyin A, Frye RF, Branch RA. CYP2D6 mRNA expression in circulating peripheral blood mononuclear cells correlates with in vivo debrisoquine hydroxylase activity in extensive metabolizers. Res Comm Molec Pathol Pharmacol 1996;91(2):149-159. 4. Matzke GR, Frye RF, *Alexander A, Reynolds R, Dixon R, Johnston J, Rault R. The effect of renal insufficiency and hemodialysis on the pharmacokinetics of nalmefene. J Clin Pharmacol 1996;36:144- 151. 5. Frye RF, Branch RA. Improved high performance liquid chromatographic determination of debrisoquine and 4-hydroxydebrisoquine in human urine following direct injection. J Chromatogr B Biomed Appl 1996 677;1:178-82. 6. Karara AH, Frye RF, Hayes PE, Weaver ML, Rault R, Robinson WT, Matzke GR. Pharmacokinetics of abecarnil in patients with renal insufficiency. Clin Pharmacol Ther 1996;59:520-8. 7. Frye RF, Matzke GR, Jallad NS, Wilhelm JA, Bikhazi GB. The effect of age on the pharmacokinetics of the opioid antagonist nalmefene. Br J Clin Pharmacol 1996;42:301-306. CV – Reginald F. Frye, Jr. Page 10

8. Frye RF, Stiff DD. Determination of chlorzoxazone and 6-hydroxychlorzoxazone in human plasma and urine by high performance liquid chromatography. J Chromatogr B Biomed Appl 1996;686(2): 291-6. 9. Frye RF, Matzke GR, Dixon R, Schade RR, Rabinovitz M. Effects of liver disease on the disposition of the opioid antagonist nalmefene. Clin Pharmacol Ther 1996;61(1):15-23. 10. Frye RF, Matzke GR, Adedoyin A, Porter J, Branch RA. Validation of the Pittsburgh cocktail approach to assess selective regulation of drug metabolizing enzymes. Clin Pharmacol Ther 1997;62(4):365-376. 11. Frye RF, Adedoyin A, Mauro K, Matzke GR, Branch RA. Use of chlorzoxazone as an in vivo probe of Cytochrome P450 2E1: Choice of dose and phenotypic trait measure. J Clin Pharmacol 1998;38:82-89. 12. Burckart GJ, Frye RF, *Kelly P, Branch RA, Jain A, Fung JJ, Starzl TE, Venkataramanan R. Induction of CYP2E1 activity in liver transplant patients as measured by chlorzoxazone 6-hydroxylation. Clin Pharmacol Ther 1998;63:296-302. 13. Frye RF, Stiff DD, Branch RA. A sensitive method for the simultaneous determination of caffeine and its dimethylxanthine metabolites in human plasma: Application to CYP1A2 phenotyping. J Liq Chrom Rel Tech 1998;21(8):1161-71. 14. *Joy MS, Matzke GR, Frye RF, Palevsky PM. Determinants of vancomycin clearance by continuous venovenous hemofiltration and continuous venovenous hemodialysis. Am J Kidney Dis 1998; 31:1019- 1027. 15. Marx MA, Frye RF, Matzke GR, Golper TA. Cefazolin as empiric therapy in hemodialysis-related infections: Efficacy and blood concentrations. Am J Kidney Dis 1998;32:410-414. 16. Adedoyin A, Frye RF, Mauro K, Branch RA. Chloroquine modulation of specific metabolizing enzymes activities: investigation with selective five drug cocktail. Br J Clin Pharmacol 1998;46(3):215-9. 17. *Dowling TC, Frye RF, Zemaitis MA. Simultaneous determination of para-aminohippuric acid, acetyl- para-aminohippuric acid and iothalamate in human plasma and urine by high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 1998; 716(1-2):305-13. 18. Murphy JE, Austin ML, Frye RF. Evaluation of gentamicin pharmacokinetics and dosing protocols in 195 neonates. Amer J Health Syst Pharm 1998; 55(21):2280-8. 19. Grabe DW, Bailie GR, Eisele G, Frye RF. Pharmacokinetics of intermittent intraperitoneal ceftazidime. Am J Kidney Dis 1999; 33(1):111-7. 20. Manley HJ, Bailie GR, Asher RD, Eisele G, Frye RF. Pharmacokinetics of intermittent intra-peritoneal cefazolin in continuous ambulatory peritoneal dialysis patients. Perit Dial Int 1999;19:65-70. 21. *Dowling TC, Frye RF, Fraley DS, Matzke GR. Comparison of iothalamate clearance methods for measuring GFR. Pharmacotherapy 1999;19(8):943-50. 22. *Dowling TC, Frye RF. Determination of famotidine in human plasma and urine by high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 1999;732:239-43. 23. Frye RF, Tammara B, Cowart TD, Bramer SL. Effect of disulfiram-mediated CYP2E1 inhibition on the disposition of vesnarinone. J Clin Pharmacol 1999; 39(11):1177-1183. 24. Matzke GR, Frye RF, Early JJ, Straka RJ, Carson SW. The influence of diabetes on drug metabolism. Pharmacotherapy 2000; 20(2):182-90. 25. Matzke GR, Frye RF, *Joy MS, Palevsky PM. Determinants of ceftazidime clearance by CVVH and CVVHD. Antimicrob Agent Chemother 2000 Jun;44(6):1639-44. 26. Frye RF, Kroboth FJ, Stone RA, Folan MM, Salek FS, Pollock BG, Linares AM, Hakala C, Kroboth PD. Sex differences in the pharmacokinetics of dehydroepiandrosterone (dhea) following single and multiple- dose administration in healthy older adults. J Clin Pharmacol 2000; 40:596-605. 27. Matzke GR, Frye RF, *Joy MS, Palevsky PM. Determinants of ceftriaxone clearance by CVVH and CVVHD. Pharmacotherapy 2000; 20(6):635-43. CV – Reginald F. Frye, Jr. Page 11

28. Manley HJ, Bailie GR, Frye RF, Hess LD, McGoldrick MD. Pharmacokinetics of intermittent intravenous cefazolin and tobramycin in patients treated with automated peritoneal dialysis. J Am Soc Neph 2000; 11: 1310-16. 29. Rosen DA, Morris JL, Rosen KR, Steelman RJ, Gustafson RA, Wilhelm J, Chang CT, Thackara J, Frye RF. Pharmacokinetics of nalmefene in pediatric patients during prophylaxis for epidural narcotics. Pharmacotherapy 2000; 20(7):745-749. 30. *Alkharfy KM, Kellum JA, Frye RF, Matzke GR. Effect of Ceftazidime on Systemic Cytokine Concentrations in Rats. Antimicrob Agents Chemother 2000 Nov;44(11):3217-3219. 31. Hutzler JM, Frye RF, Tracy TS. Sensitive and specific high-performance liquid chromatography assay for 4’-hydroxyflurbiprofen and flurbiprofen in urine and plasma. J Chromatogr B Biomed Sci Appl 2000; 749(1):119-125. 32. Manley HJ, Bailie GR, Frye RF, McGoldrick MD. Pharmacokinetics of intermittent intravenous piperacillin in patients treated with automated peritoneal dialysis. Perit Dial Int 2000; 20:686-94. 33. Branch RA, Adedoyin A, Frye RF, Wilson J, Romkes M. In vivo modulation of CYP enzymes by quinidine and rifampin. Clin Pharmacol Ther 2000; 68:401-11. 34. *Dowling TC, Frye RF, Fraley DS, Matzke GR. Characterization of tubular functional capacity in man using PAH and famotidine. Kidney Int 2001;59:295-303. 35. *Alkharfy KM, Frye RF. High-performance liquid chromatographic assay for acetaminophen glucuronide in human liver microsomes. J Chromatogr B Biomed Sci Appl 2001 Apr 5;753(2):303-8. 36. Sowinski KM, Mueller BA, Grabe DW, Manley HJ, Frye RF, Bailie GR, and Marx MA. Cefazolin Dialytic Clearance by High-Efficiency and High-Flux Hemodialyzers. Am J Kidney Dis 2001;37(4):766- 776. 37. Hutzler JM, Frye RF, Korzekwa KR, Branch RA, Huang SM, Tracy TS. In vivo activation of CYP2C9- mediated flurbiprofen metabolism by dapsone. Eur J Pharm Sci 2001 Aug;14(1):47-52. 38. Manley HJ, Bailie GR, Frye RF, McGoldrick MD. Intravenous vancomycin pharmacokinetics in automated peritoneal dialysis patients. Perit Dial Int 2001; 21(4): 378-85. 39. Frye RF, Branch RA. Effect of chronic disulfiram administration on activities of CYP1A2, CYP2C19, CYP2D6, CYP2E1, and N-acetyltransferase in healthy human subjects. Br J Clin Pharmacol 2002; 53:155-162. 40. *Nolin TD, *Colaizzi IV, Palevsky PM, Matzke GR, and Frye RF. Rapid Microtiter Plate Assay for Determination of Inulin in Human Plasma and Dialysate. J Pharm Biomed Anal 2002;28:209-215. 41. *Alkharfy KM, Frye RF. Sensitive HPLC-fluorescence method for the determination of estradiol-3 and 17 glucuronides in rat and human liver microsomes. J Chromatogr B Biomed Sci Appl 2002;774:33-38. 42. Zemaitis M, Poloyac S, Frye R. Identification of omega hydroxy fatty acids in biological samples as their pentafluoropropyl derivatives by gas chromatography/mass spectrometry with positive and negative ion detection. Rapid Commun Mass Spectrom 2002; 16: 1411-15. 43. *Islam M, Frye RF, Richards TJ, Sbeitan I, Donnelly SS, Glue P, Agarwala SS, Kirkwood JM. Differential Effect of Interferon Alfa-2b (IFNa2b) on the Cytochrome P450 Enzyme System: A Potential Basis of IFN Toxicity and its Modulation by Other Drugs. Clinical Cancer Research 2002;8(8): 2480-7. 44. Solai LK, Pollock BG, Mulsant BH, Frye RF, Miller M, Sweet R, Kirshner M, Sorisio D, Begley A, and Reynolds CF. Effect of nortriptyline and paroxetine on CYP2D6 activity in depressed elderly patients. J Clin Psychopharmacol 2002; 22: 481-6. 45. Frye RF, Schneider VM, Frye CS, Feldman AM. Plasma levels of TNF-α and IL-6 are inversely related to cytochrome P450-dependent drug metabolism in patients with congestive heart failure. J Card Failure 2002; 8(5):315-9. CV – Reginald F. Frye, Jr. Page 12

46. *Lee JI, Chaves-Gnecco D, Amico JA, Kroboth PD, Wilson JW, Frye RF. Application of semisimultaneous midazolam administration for hepatic and intestinal CYP3A phenotyping. Clin Pharmacol Ther 2002;72:718-28. 47. *Nolin TD, Frye RF. Stereoselective determination of the CYP2C19 probe drug mephenytoin in human urine by gas chromatography mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2003;783:265-271. 48. Lee CR, Pieper JA, Frye RF, Hinderliter AL, Blaisdell JA, Goldstein JA. Tolbutamide, Flurbiprofen and Losartan as Probes of CYP2C9 Activity in Humans. J Clin Pharmacol 2003;43:84-91. 49. Kroboth PD, Amico JA, Stone RA, Folan MM, Frye RF, Kroboth FJ, Bigos KL, Fabian TJ, Linares AM, Pollock BG, Hakala C. Influence of DHEA Administration on 24-Hour Cortisol Concentrations. J Clin Psychopharmacol 2003; 23(1):96-99. 50. Chalon SA, Desager JP, DeSante KA, Frye RF, Witcher J, Long AJ, Sauer JM, Golnez JL, Smith BP, Thomasson HR, Horsmans Y. Effect of hepatic impairment on the pharmacokinetics of atomoxetine and its metabolites. Clin Pharmacol Ther. 2003 Mar;73(3):178-191. 51. Lee CR, Pieper JA, Frye RF, Hinderliter AL, Blaisdell JA, Goldstein JA. Flurbiprofen Metabolism in CYP2C9*1 Heterozygotes. Eur J Clin Pharmacol 2003; 58(12):791-4. 52. Carcillo JA, Doughty L, Kofos D, Frye RF, Kaplan SS, Sasser H, Burckart GJ. Cytochrome P450 mediated-drug metabolism is reduced in children with sepsis-induced multiple organ failure. Intensive Care Med. 2003; Jun;29(6):980-4. 53. Carcillo JA, Adedoyin A, Burckart GJ, Frye RF, Venkataramanan R, Knoll C, Thummel K, Roskos L, Wilson JW, Sereika S, Romkes M, Bebia Z, Branch RA. Coordinated Intrahepatic and Extrahepatic Regulation of CYP2D6 in Health and Following Liver Transplantation. Clin Pharmacol Ther 2003; 73: 456-67. 54. *Bolcato CA, Frye RF, Poloyac SM. Determination of 20-hydroxyeicosatetraenoic acid (20-HETE) in microsomal incubates using high-performance liquid chromatography–mass spectrometry (HPLC-MS). J Chromatogr B 2003:794:363-372. 55. *Dix J, Weber RJ, Frye RF, Nolin TD, Mrvos R, Krenzelok E. Stability of atropine sulfate prepared for mass chemical terrorism. Journal of Toxicology - Clinical Toxicology 2003; 41(6):771-775. 56. *Nolin TD, Gastonguay MR, Bies RR, Matzke GR, Frye RF. Impaired 6-Hydroxychlorzoxazone elimination in patients with kidney disease: implication for CYP2E1 pharmacogenetic studies. Clin Pharmacol Ther 2003;74(6):555-568. 57. *Hruska MW, Frye RF. Simplified method for determination of rosiglitazone in human plasma. J Chromatogr B 2004;803:317-20. 58. Komoroski BJ, Zhang S, Cai H, Hutzler JM, Frye R, Tracy TS, Strom SC, Lehmann T, Ang, Yan CY, Cui Y, Venkataramanan R. Induction and inhibition of cytochromes P450 by the St. John's wort constituent hyperforin in human hepatocyte cultures. Drug Metab Dispos 2004 May;32(5):512-8. 59. Poloyac SM, Tortorici MA, Przychodzin DI, Reynolds RB, Xie W, Frye RF, Zemaitis MA. The effect of isoniazid on CYP2E1 and CYP4A mediated hydroxylation of arachidonic acid in the rat liver and kidney. Drug Metab Dispos 2004 July;32(7):727-33. 60. *Hruska MW, Frye RF. Determination of trimethoprim in low-volume human plasma by liquid chromatography. J Chromatogr B 2004; 807(2):301-5. 61. Frye RF, *Fitzgerald SM, Lagattuta TF, *Hruska MW, Egorin MJ. Effect of St. John’s wort on imatinib mesylate pharmacokinetics. Clin Pharmacol Ther 2004;76:323-9. 62. Elwell RJ, Volino LR, Frye RF. Stability of Cefepime in Icodextrin Peritoneal Dialysis Solution. Ann Pharmacother 2004;38(12):2041-4. CV – Reginald F. Frye, Jr. Page 13

63. *Hruska MW, Frye RF, Langaee TY. A Pyrosequencing Method for Genotyping Cytochrome P450 2C8 and 2C9 Enzymes. Clin Chem 2004; 50(12):2392-5. 64. Bebia Z, Buch SC, Wilson JW, Frye RF, Romkes M, Cecchetti A, Chaves-Gnecco D, Branch RA. Bio- equivalence revisited: Influence of age and sex on CYP enzymes. Clin Pharmacol Ther 2004;76:618-27. 65. *Hruska MW, Amico JA, Langaee TY, Ferrell RE, Fitzgerald SM, Frye RF. The Effect of Trimethoprim on CYP2C8 Mediated Rosiglitazone Metabolism in Human Liver Microsomes and Healthy Subjects. Br J Clin Pharmacol 2005;59(1):70-9. 66. Harbrecht BG, Frye RF, Zenati MS, Branch RA, Peitzman AB. Cytochrome P-450 activity is differentially altered in severely injured patients. Crit Care Med. 2005 Mar;33(3):541-6. 67. Liu S, Frye RF, Branch RA, Venkataramanan R, Fung J, Burckart GJ. Changes in CYP450 enzyme activity over time following liver transplantation. J Clin Pharmacol. 2005 Jun;45(6):666-73. 68. Elwell RJ, Frye RF, Bailie GR. Pharmacokinetics of intraperitoneal cefepime in automated peritoneal dialysis. Perit Dial Int 2005 Jul-Aug;25:380-6. 69. Elwell RJ, Manley HJ, Frye RF, Bailie GR. Pharmacokinetics of intraperitoneal cefazolin and ceftazidime coadministered to CAPD Patients. Int J Artif Organs 2005;28(8):808-16. 70. Haas CE, Brazeau D, Cloen D, Booker BM, Frerichs V, Zaranek C, Frye RF, Kufel T. Cytochrome P-450 mRNA expression in peripheral blood lymphocytes as a predictor of enzyme induction. Eur J Clin Pharmacol 2005; Sep;61(8):583-93. 71. Frye RF, *Zgheib NK, Matzke GR, Chaves-Gnecco D, Rabinovitz M, Shaikh OS, Branch RA. Liver disease selectively modulates cytochrome P450-mediated metabolism. Clin Pharmacol Ther 2006; 80:235-45. 72. *Zgheib NK, Frye RF, Tracy TS, Romkes M, Branch RA. Validation of incorporating flurbiprofen into the Pittsburgh cocktail. Clin Pharmacol Ther 2006; 80:257-63. 73. O’Connell MB, Frye RF, Matzke GR, St. Peter JV, Willhite LA, Welch MR, Kowal P, LaValleur J. Effect of conjugated equine estrogens on oxidative metabolism in middle-age and elderly postmenopausal women. J Clin Pharmacol 2006; 46(11):1299-307. 74. Blowey DL, Warady BA, Abdel-Rahman S, Frye RF, Manley HJ. Vancomycin disposition following intraperitoneal administration in children receiving peritoneal dialysis. Perit Dial Int 2007; Jan- Feb;27(1):79-85. 75. *Alkharfy KM, Frye RF. Effect of valerian, valerian/hops extracts, and valerenic acid on glucuronidation in vitro. Xenobiotica 2007;37:113-23. 76. *Zgheib NK, Frye RF, Tracy TS, Romkes M, Branch RA. Evaluation of flurbiprofen urinary ratios as in vivo indexes for CYP2C9 activity. Br J Clin Pharmacol 2007;63(4):477-87. 77. *Dravid PV, Frye RF. Determination of N-desethylamodiaquine by hydrophilic interaction liquid chromatography with tandem mass spectrometry: application to in vitro drug metabolism studies. J Chromatogr B 2008; 863: 129-34. 78. Johnson JA, Moore MJ, Shin J, Frye RF. Fostering PharmD student interest in research through a formalized summer research training program. Am J Pharm Educ (in press). 79. Elewa HF, Kozak A, Frye R, Johnson MH, Ergul A, Fagan SC: Effect of early atorvastatin on hemorrhagic transformation after acute cerebral ischemia in diabetic rats. (submitted to Stroke). 80. Pacanowski M, Frye RF, *Enogieru O, Schofield RS, Zineh I. Plasma Coenzyme Q10 Predicts Lipid- lowering Response to High-Dose Atorvastatin. (submitted).

CV – Reginald F. Frye, Jr. Page 14

ABSTRACTS & SCIENTIFIC PRESENTATIONS: * = individuals in training are indicated by an asterisk 1. Frye RF, Marshall LL, Murphy JE, Goodhart GL. An evaluation of cefpirome use in adult patients with urinary tract infections. American Society of Hospital Pharmacists Midyear Clinical Meeting, Atlanta, GA. December, 1990. 2. Marshall LL, Frye RF, Murphy JE, Goodhart GL. Experiences in a phase III clinical trial: a student's perspective. American Society of Hospital Pharmacists Midyear Clinical Meeting, Atlanta, GA. December, 1990. 3. Frye RF, Job ML, Dretler RH. Teicoplanin nephrotoxicity: first case report. American College of Clinical Pharmacy Annual Meeting, San Francisco, CA. August, 1990. Pharmacother 1990;10:234. 4. Matzke GR, Carson SW, Millikin SP, Frye RF. The use of saliva concentrations to determine antipyrine pharmacokinetics in patients with various degrees of renal function. American Society for Clinical Pharmacology and Therapeutics, San Antonio, TX. March, 1991. Clin Pharmacol Ther 1991;49(2):171. 5. Matzke GR, Halstenson CE, Frye RF. An assessment of predicted vs. actual fractional drug removal by hemodialysis. Winter Practice and Research Forum of the American College of Clinical Pharmacy, Ft. Lauderdale, FL. February, 1991. Pharmacother 1991;11:106. 6. Frye RF, Carson SW, Matzke GR. Effect of type I diabetes mellitus and renal insufficiency on hepatic P450 oxidative metabolism. Winter Practice and Research Forum of the American College of Clinical Pharmacy, Ft. Lauderdale, FL. February, 1991. Pharmacother 1991;11:96. 7. Matzke GR, Frye RF, Dupuis RE, Harris TG. Optimization of vancomycin Bayesian analysis: Initial population parameters (IPP) vs. forecasting programs. American College of Clinical Pharmacy Annual Meeting, Minneapolis, MN. August, 1991. Pharmacother 1991;11:267-8. 8. Matzke GR, Frye RF, Carson SW, Venkataramanan R, Jelliffe RW. Utility of antipyrine (AP) population pharmacokinetic parameters (PPP) derived from subjects with normal and impaired hepatic function (IHF) to predict AP pharmacokinetics in subjects with renal insufficiency. American Association of Pharmaceutical Scientists Annual Meeting, Washington, D.C. November, 1991. Pharm Research 1991; 8(10):60 and Pharmacother 1991;11(6):P41. 9. Carson SW, Frye RF, Matzke GR. A micro HPLC assay for determination of antipyrine and its metabolites in human urine. American Association of Pharmaceutical Scientists Annual Meeting, Washington, D.C. November, 1991. Pharm Research 1991; 8(10):20. 10. Murphy JE, Frye RF, Erkan V, Fakhreddine F. Evaluating gentamicin dosing methods in premature and normal gestation neonates utilizing first dose pharmacokinetic data. American College of Clinical Pharmacology, September, 1991. J Clin Pharmacol 1991; 31:846. 11. Matzke GR, Halstenson CE, Frye RF. Hemodialysis clearance (CLhd) of aminoglycosides and cephalosporins. 31st Interscience Conference on Antimicrobial Agents and Chemotherapeutics, Chicago, IL. October, 1991 and encore presentation at Winter Practice and Research Forum of the American College of Clinical Pharmacy, Phoenix, AZ. February, 1992. Pharmacother 1992;11(6):P41. 12. Frye RF, Matzke GR, Carson SW, Cohen HJ, Pritchett ELC. Effect of age and gender on antipyrine disposition. American Society for Clinical Pharmacology and Therapeutics, Orlando, FL. March, 1992. Clin Pharmacol Ther 1992;51:174. 13. Matzke GR, Frye RF, Carson SW, Millikin SP, Lyon JA. The influence of type I and type II diabetes mellitus on antipyrine disposition. American Society for Clinical Pharmacology and Therapeutics, Orlando, FL. March, 1992. Clin Pharmacol Ther 1992;51:134. 14. Frye RF, Matzke GR, Adedoyin A, Stiff DD, Porter J, Kubisty C, Branch RA. Utility of a cocktail strategy in assessing in vivo hepatic drug metabolism. Gordon Research Conference on Drug Metabolism, Plymouth, NH. July, 1992. CV – Reginald F. Frye, Jr. Page 15

15. Matzke GR, Comstock TJ, Frye RF, Gillikin S, Rault RM, Schwinghammer TL, Kirschbaum B. The pharmacokinetics of epoetin alfa (EPO) are nonlinear following low dose administration. American Society of Nephrology Annual Meeting, Baltimore, MD. November, 1992. J Amer Soc Neph 1992;3(3):428. 16. Matzke GR, Frye RF, *Poloyac S. Pharmacodynamic modeling of erythropoietin (EPO) therapy. American Society of Nephrology Annual Meeting, Baltimore, MD. November, 1992. J Amer Soc Neph 1992;3(3):428. and encore presentation at American College of Clinical Pharmacy, Ft. Lauderdale, FL. February, 1993. Pharmacother 1993;12(6):504. 17. Matzke GR, *Poloyac S, Rault RM, Frye RF. Effect of time, dose, and hematocrit on erythropoietin disposition. American Society of Nephrology Annual Meeting, Boston, MA. November, 1993. J Amer Soc Neph 1993;4(3):428. 18. Frye RF, Stiff DD, Matzke GR, Branch RA. A sensitive method for the simultaneous determination of caffeine and its dimethylxanthine metabolites in human serum, saliva, and plasma. American Association of Pharmaceutical Scientists Annual Meeting, Orlando, FL, November, 1993. Pharm Research 1993;10(10):S43. 19. Frye RF, Stiff DD, Matzke GR, Adedoyin A, Kubisty C, Branch RA. Pharmacokinetics of chlorzoxazone: an in vivo probe of cytochrome P4502E1 activity. American Association of Pharmaceutical Scientists Annual Meeting, Orlando, FL, November, 1993. Pharm Research 1993;10(10):S388. 20. Frye RF, Matzke GR, Stiff DD, Adedoyin A, Porter J, Kubisty C, Branch RA. Validation of a five drug cocktail for use in population phenotyping. American Association of Pharmaceutical Scientists Annual Meeting, Orlando, FL, November, 1993. Pharm Research 1993;10(10):S388 and encore presentation at American College of Clinical Pharmacy Annual Meeting, St. Louis, MO. July, 1994. 21. Frye RF, Matzke GR, Rabinovitz M, Schade RR. Establishment of a quantitative hepatic function monitoring program. American College of Clinical Pharmacy Annual Meeting, St. Louis, MO. July, 1994. Pharmacother 1994;14:38. 22. Matzke GR, Frye RF, Carson SW, Cohen HJ, Pritchett ELC. Disposition of antipyrine and its metabolites in healthy, elderly, non-smoking males and females. 1994 Annual Meeting of American Geriatrics Society/American Federation for Aging Research. Los Angeles, CA. May 21, 1994. 23. Schade R, Nelson F, Matzke GR, Frye R. Salivary Caffeine/Antipyrine Clearance: A non-invasive approach to hepatic functional capacity. American Gastroenterology Association. San Francisco, CA. September 18-19, 1994. 24. Nelson FA, Frye R, Matzke G, Schade RR. Caffeine / Antipyrine clearance : A better tool for assessment of hepatic functional capacity in patients with hepatitis C ? Hepatology 1994;20(4):381. 25. Matzke GR, Comstock T, Frye RF, Weiner M, Carter W. Computerized bayesian pharmacodynamic modeling for erythropoietin dosage individualization. 27th Annual Meeting of the American Society of Nephrology. Orlando, FL. October, 1994. J Amer Soc Neph 1994;5(4):464 and encore presentation at American College of Clinical Pharmacy Annual Meeting, Washington, D.C. August, 1995. 26. Matzke GR, *Alexander ACM, Frye RF, Reynolds R, Palevsky P, Johnston J, Whitman C, Dixon RB, Rault R. The effect of hemodialysis on the disposition of nalmefene and nalmefene glucuronide. 27th Annual Meeting of the American Society of Nephrology. Orlando, FL. October 26-29, 1994. J Amer Soc Neph 1994;5(4):499. 27. Adedoyin A, Mauro K, Frye R, Porter J, Branch RA. Selective modulation of specific metabolizing activities by chloroquine. American Society for Clinical Pharmacology and Therapeutics, San Diego, CA. March, 1995. Clin Pharmacol Ther 57(2):150. CV – Reginald F. Frye, Jr. Page 16

28. Matzke GR, Karara A, Hayes P, Frye RF, Weaver ML, Rault R, Robinson WT. Effect of renal insufficiency on the pharmacokinetics of abecarnil. American Society for Clinical Pharmacology and Therapeutics, San Diego, CA. March, 1995. Clin Pharmacol Ther 1995;57(2):218. 29. Matzke GR, *Alexander A, Frye RF, Reynolds R, Whitman C, Dixon R, Rault R. The disposition of nalmefene is significantly altered in patients with end stage renal disease. American Society for Clinical Pharmacology and Therapeutics, San Diego, CA. March, 1995. Clin Pharmacol Ther 1995;57(2):218. 30. Frye RF, Mauro K, Adedoyin A, Matzke GR and Branch RA. Nonlinear pharmacokinetics of chlorzoxazone in humans. American Society for Clinical Pharmacology and Therapeutics, San Diego, CA. March, 1995. Clin Pharmacol Ther 1995;57: 217. 31. Frye RF, Matzke GR, Schade RR. Lack of correlation between Pugh score and quantitative measures of hepatic function in patients with hepatitis C. American College of Clinical Pharmacy Annual Meeting, Washington, DC. August, 1995 and Pharmacother 1995;15(3): 389-90. 32. Frye RF, Matzke GR, McVey JL, Reynolds R, Dixon R, Rabinovitz M, Schade RR. Effect of hepatic insufficiency on the pharmacokinetics of nalmefene. American College of Clinical Pharmacy Annual Meeting, Washington, DC. August, 1995 and Pharmacother 1995;15(3): 390. 33. *Kelly PA, Frye RF, Burckart GJ, Lever J, Venkataramanan RV, Fung JJ, Matzke GR, Branch RA. Differential recovery of cytochrome P450 isozymes following orthotopic liver transplantation. American College of Clinical Pharmacy Annual Meeting, Washington, DC. August, 1995 and Pharmacother 1995;15(3): 396. 34. Adedoyin A, Frye RF, Matzke GR, Stiff DD, Branch RA. A model to study metabolic drug interaction in vivo: Use of a five drug cocktail. American Association of Pharmaceutical Scientists Annual Meeting, Miami, FL, November, 1995 and Pharm Research 1995;12(9):S373. 35. Frye RF, Matzke GR, Adedoyin A, Schade RR, Branch RA. Effect of liver disease on CYP activity assessed utilizing a cocktail approach. American Association of Pharmaceutical Scientists Annual Meeting, Miami, FL, November, 1995 and Pharm Research 1995;12(9):S380. 36. Matzke GR, *Joy M, Palevsky P, Frye R, Johnston J, Greenberg A. Continuous venovenous hemodialysis clearance of vancomycin is highly membrane dependent. International Conference on Continuous Renal Replacement Therapies. San Diego, CA., November, 1995 and Blood Purif 1995;13:401. 37. Comstock TJ, Matzke GR, *Joy MS, Frye RF, Dover T. Pharmacist training for an outcomes-based multicenter clinical trial. Thirtieth ASHP Midyear Clinical Meeting. Las Vegas, NV. December, 1995, and Int Pharmaceutical Abstracts 1995; 32:2405. 38. *Alexander ACM, Matzke GR, Frye RF, Bruns F, Rault R. Differential response of serum iron indices (SII) to iron dextran (ID) in hemodialysis patients. American Society for Clinical Pharmacology and Therapeutics, Orlando, FL, March, 1996 and Clin Pharmacol Ther 1996;59: 155. 39. *Kelly PA, Frye RF, Burckart GJ, Lever J, Venkataramanan RV, Fung JJ, Matzke GR, Branch RA. Differential CYP450 isozyme activity following orthotopic liver transplantation. American Society for Clinical Pharmacology and Therapeutics, Orlando, FL, March, 1996 and Clin Pharmacol Ther 1996;59: 136. 40. Frye RF, Matzke GR, *Alexander ACM, Palevsky P, Rault R, Branch RA. Effect of renal insufficiency on CYP activity. American Society for Clinical Pharmacology and Therapeutics, Orlando, FL, March, 1996 and Clin Pharmacol Ther 1996;59: 155. 41. Frye RF, Matzke GR, Palevsky P, Rault R. Impaired 6-hydroxychlorzoxazone elimination in patients with renal insufficiency: Implication for pharmacogenetic studies. American Society for Clinical Pharmacology and Therapeutics, Orlando, FL, March, 1996 and Clin Pharmacol Ther 1996;59: 168. CV – Reginald F. Frye, Jr. Page 17

42. *Kelly PA, Frye RF, Burckart GJ, Venkataramanan R, Jain A, Fung JJ, Romkes M, Branch RA. Tacrolimus dosing in stable liver transplant (OLTX) recipients correlates with phenotypic CYP3A4 enzyme activity but not leukocyte CYP3A4 mRNA expression. American Society of Transplant Physicians Annual Meeting, Dallas, TX, May, 1996. 43. Matzke GR, Frye RF, *Joy M, Palevsky P. Continuous venovenous hemodialysis (CVVHD) clearance of ceftriaxone. 42nd Annual Conference with the Cardiovascular Science and Technology Conference Washington, DC. May 2-4, 1996, and ASAIO Journal 1996; 42(2):90. 44. Eibling DE, Romkes M, Adedoyin A, White C, Frye R, Johnson J, Branch RA. Evaluation of CYP2D6 genotype and phenotype in patients with head and neck cancer. Presented at the 4th International Conference on Head and Neck Cancer. Toronto, Ontario, Canada, July 1996. 45. *Kelly PA, Burckart GJ, Zeevi A, Banas R, Pavlik M, Frye RF, Duquesnoy R, Venkataramanan R, Fung JJ. Immune modulating effects of ciprofloxacin on peripheral blood lymphocytes. American College of Clinical Pharmacy Annual Meeting, Nashville, TN. August, 1996. 46. Matzke GR, Frye RF, *Joy MS, Palevsky P. Determinants of ceftriaxone clearance by CVVHD and CVVH. Annual Meeting of the American Society of Nephrology. New Orleans, LA., November 1996, and J Amer Soc Neph 1996; 7(9) 1521. 47. Matzke GR, *Joy MS, Frye RF, Palevsky P. Clearance of ceftazidime by continuous venovenous hemofiltration (CVVH) and hemodialysis (CVVHD). Annual Meeting of the American Society of Nephrology. New Orleans, LA., November 1996, and J Amer Soc Neph 1996; 7(9) 1521. 48. *Pecora PG, Frye RF, Ptachcinski RJ. Stability of omeprazole in alkaline solutions. ASHP Midyear Clinical Meeting. New Orleans, LA. December, 1996. 49. *Berringer RA, Frye RF, Matzke GR. Clinical significance of vancomycin removal during high-flux hemodialysis. ASHP Midyear Clinical Meeting. New Orleans, LA. December, 1996. 50. Doughty L, Kaplan S, Burckart G, Frye R, Carcillo J. Cytochrome P450 (P450) function is decreased in pediatric sepsis-induced multiple organ failure. Crit Care Med 1997;25(1):A125. 51. *Dowling TD, Frye RF, Matzke GR, Fraley DS. Para-aminohippuric acid renal clearance after an intravenous bolus is not an accurate marker of effective renal plasma flow. American Society for Clinical Pharmacology and Therapeutics, San Diego, CA, March, 1997 and Clin Pharmacol Ther 1997;61: 215. 52. Romkes M, Adedoyin A, White C, Frye R, Johnson J, Eibling D, Branch R. Role of CYP and Phase II enzymes in head and neck cancer risk. Proc Am Assoc Cancer Res 1997;38:1452. 53. *Dowling TD, Frye RF, Matzke GR, Fraley DS, Rabinovitz M. Reduced acetylation of para- aminohippuric acid in liver disease. American Society for Clinical Pharmacology and Therapeutics, San Diego, CA, March, 1997 and Clin Pharmacol Ther 1997;61: 215. 54. O’Connell MB, Frye RF, St. Peter JV, Matzke GR, La Valleur J. Effect of conjugated estrogen replacement therapy on CYP activity. American Society for Clinical Pharmacology and Therapeutics, San Diego, CA, March, 1997 and Clin Pharmacol Ther 1997;61: 226. 55. *Dowling TC, Frye RF, Matzke GR, Fraley DS. Characterization of saturable renal elimination of para- aminohippurate (PAH) and its acetyl metabolite in man. 1997 Spring Practice and Research Forum. American College of Clinical Pharmacy. Panama City, FL. April 6-9, 1997. 56. *Kearney B, Frye RF. Dextromethorphan as a CYP3A4/5 probe: Evaluation of plasma-based phenotypic trait measures. Eastern States Residents Conference, May 1997. 57. Marx MA, Frye RF, Matzke GR, Golper TA. Cefazolin is efficacious for empiric treatment of hd-related infections. 15th meeting of the International Society of Blood Purification, 1997. 58. *Kofos D, Frye R, Burckart G, Reyes J, Carcillo J. Drug metabolism in pediatric liver transplantation. Ped Res 1997;41(4):36A. CV – Reginald F. Frye, Jr. Page 18

59. Doughty L, Kaplan S, Burckart G, Frye R, Carcillo J. Cytochrome P450 function in pediatric sepsis- induced multiple organ failure. Ped Res 1997;41(4):32A. 60. Frye RF, Bertz RJ, Granneman GR, Qian J, Lamm J, Dennis S, Valdes J. Effect of ritonavir on the pharmacokinetics and pharmacodynamics of alprazolam. 37th Interscience Conference on Antimicrobial Agents and Chemotherapeutics, Toronto, Ontario, Can. September 1997. 61. Marx MA, Frye RF, Matzke GR, Golper TA. Cefazolin for empiric treatment of hd-related infections: efficacy and blood concentrations. 30th Annual Meeting of the American Society of Nephrology. San Antonio, TX. November, 1997. J Amer Soc Neph 1997;8:202A-3A. 62. Grabe DW, Bailie GR, Frye RF. Pharmacokinetics of intermittent intraperitoneal ceftazidime in CAPD patients with and without residual renal function. American College of Clinical Pharmacy Annual Meeting, Phoenix, AZ. November, 1997 and Pharmacother 1997;17(5): 1099. 63. *Kofos D, Frye R, Burkcart G, Carcillo J. Diminished oxidative metabolizing capacity of specific cytochrome P450 (P450) isozymes in sepsis induced pediatric multiple organ failure (MOF). Society of Critical Care Medicine Annual Meeting. Crit Care Med 1998;26(1):A79. 64. *Dowling TC, Frye RF, Matzke GR, Fraley DS. Bolus administration of nonradiolabeled iothalamate (NRI) provides an accurate index of glomerular filtration rate (GFR). Seventh Annual Spring Clinical Nephrology Meeting, Nashville, TN. March 26-29, 1998, and Am J Kidney Dis 1998; 31: A14. 65. Adedoyin A, Trump DL, Brufsky A, Frye RF, Hofacker J, Branch RA. Selective alteration of specific metabolizing enzyme activities by disulfiram and ketoconazole. American Society for Clinical Pharmacology and Therapeutics, New Orleans, LA, March, 1998 and Clin Pharmacol Ther 1998;63:154. 66. Frye RF, Bertz RJ, Granneman GR, Lauva I, Lamm J, Dennis S,Valdes J. Effect of ritonavir on CYP1A2, 2C19, and 2E1 activities in vivo. American Society for Clinical Pharmacology and Therapeutics, New Orleans, LA, March, 1998 and Clin Pharmacol Ther 1998;63:148; Encore Presentation 1998 ACCP Annual Meeting, Cincinnati, OH, November 1998. 67. *Opatik LM, Frye RF, *Campbell JA, Ptachcinski RJ, Shapiro R, Marsh JW. Valacyclovir bioavailability in kidney and liver transplant patients. Presented at the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, CA. September 1998; Encore Presentation 1998 ACCP Annual Meeting, Cincinnati, OH, November 1998. 68. *Dowling TC, Frye RF, Fraley DS, Matzke GR. Tubular secretion of famotidine in man is not capacity limited. J Amer Soc Neph 1998; 9:69A. 69. *Dowling TC, Frye RF, Fraley DS, Matzke GR. Validation of a sequential PAH infusion method to characterize anionic tubular secretion in man. 31st Annual Meeting of the American Society of Nephrology. Philadelphia, PA. November 1998 and J Amer Soc Neph 1998; 9:70A. 70. Frye RF, Kroboth PD, Linares AM, Folan MM, Hakala C, Stone R, Kroboth FJ. Gender differences in the pharmacokinetics of dehydroepiandrosterone following single and multiple-dose administration in healthy older adults. Presented at the 1998 Society for Neuroscience Annual Meeting, November 1998, Los Angeles, CA; Encore Presentation 1998 ACCP Annual Meeting, Cincinnati, OH, November 1998. 71. Folan M, Kroboth P, Stone R, Frye R, Kroboth F, Sweeney J. Endogenous dehydroepiandrosterone (DHEA), DHEA-S and saccadic eye movement (SEM) function in older adults. Presented at the 1998 Society for Neuroscience Annual Meeting, November 1998, Los Angeles, CA; Encore Presentation 1998 ACCP Annual Meeting, Cincinnati, OH, November 1998. 72. Frye RF. Evaluation of the selectivity of disulfiram inhibition on in vivo cytochrome P450 activity. Presented at the 1998 ACCP Annual Meeting, Cincinnati, OH, November 1998 and Pharmacother 1998;18:1157. CV – Reginald F. Frye, Jr. Page 19

73. *Al-Kharfy K, Matzke GR, Frye RF, Kellum JA. Ceftazidime clearance in septic and non-septic rats receiving continuous arteriovenous hemofiltration (CAVH). Presented at the 1999 ACCP Spring Meeting, Orlando, FL. 74. *Islam, M, Donnelly S, Kirkwood J, Frye RF. Differential effect of IFN ([alpha]-2b) on the CYP450 enzyme system: a potential issue of ifn toxicity and its modulation by other drugs. Presented at the 1999 Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA., May 1999. 75. Burckart GJ, Frye RF, Branch RA, Venkataramanan R, McKaveney T, Hammond R, Rosenberg C, Fung JJ, Jain A. Drug metabolism in older OLTX patients: effects of donor and recipient age. Presented at the American Society of Transplant Physicians Annual Meeting, May, 1999. 76. Chaves-Gnecco DG, Branch RA, Cressman MD, Frye RF, Vyas SJ, Cannon YM, Pauli MM, Data JL, Ramu K, Daniell G. An open-label, crossover Phase I pharmacokinetics study of licostinel alone or in combination with probenecid in healthy volunteers. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, New Orleans, LA, November, 1999. 77. Matzke GR, Frye RF, Nolin TD, Baritot DA, Palevsky PM. Vancomycin removal by low and high flux hemodialysis with polymethylmethacrylate dialyzers. Presented at the Annual Meeting of the American Society of Nephrology, November 1999 and J Amer Soc Neph 1999;10:193A. 78. Matzke GR, Frye RF, Nolin TD, Baritot DA, Palevsky PM. Cefazolin and ceftazidime clearance during hemodialysis with low and high flux polymethylmethacrylate dialyzers. Presented at the Annual Meeting of the American Society of Nephrology, November 1999 and J Amer Soc Neph 1999;10:193A. 79. Matzke GR, Nolin TD, Frye RF, Baritot DA, Palevsky PM. In vitro model for tobramycin disposition during hemodialysis with low and high flux biocompatible membranes. Presented at the Annual Meeting of the American Society of Nephrology, November 1999 and J Amer Soc Neph 1999;10:193A. 80. Frye RF, Tracy TS, Hutzler JM, Huang SM, Branch RA. Flurbiprofen as a selective in vivo probe of CYP2C9 activity. Presented at the American Society for Clinical Pharmacology and Therapeutics, Los Angeles, CA, March, 2000 and Clin Pharmacol Ther 2000;67:109. 81. Frye RF, Kroboth PD, Folan MM, et al. Effect of DHEA on CYP3A-mediated metabolism of triazolam. Presented at the American Society for Clinical Pharmacology and Therapeutics, Los Angeles, CA, March, 2000 and Clin Pharmacol Ther 2000;67:109. 82. Wilson JW, Frye RF, Huang SM, Branch RA. Sample size effects in assessing gender population bioequivalence (GPB) in a Pittsburgh cocktail. Presented at the American Society for Clinical Pharmacology and Therapeutics, Los Angeles, CA, March, 2000 and Clin Pharmacol Ther 2000;67:116. 83. Hutzler JM, Frye RF, Korzekwa KR, Branch RA. Does dapsone-mediated activation of flurbiprofen metabolism by CYP2C9 occur in vivo? Presented at the American Society for Clinical Pharmacology and Therapeutics, Los Angeles, CA, March, 2000 and Clin Pharmacol Ther 2000;67:134. 84. *Alkharfy KM, Frye RF. Determination of acetaminophen glucuronide in human liver microsomes. Presented at the annual meeting of the International Society for the Study of Xenobiotics, October 2000 and Drug Metab Rev 2000; 32(suppl 2): 177. 85. Poloyac SM, Zemaitis MA, Frye RF. Cytochrome P450 mediated arachidonic acid metabolism: tissue specific activity and alterations by endotoxin. Presented at the annual meeting of the International Society for the Study of Xenobiotics, October 2000. Drug Metab Rev 2000; 32(suppl 2): 220. 86. Matzke GR, Palevsky PM, Frye RF. In-vitro model for tobramycin disposition during hemodialysis with conventional and high flux biocompatible membranes. Presented at the American Society of Nephrology Annual Meeting, October, 2000. 87. Matzke GR, Palevsky PM, Frye RF. In-vitro model for ceftazidime disposition during hemodialysis with conventional and high flux biocompatible membranes. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, November, 2000. CV – Reginald F. Frye, Jr. Page 20

88. Muir K, Frye RF, Arumugham T, Sale M. Lack of effect of GW320659 on cytochrome P450 (CYP450) activity. Presented at the American Society for Clinical Pharmacology and Therapeutics, Orlando, FL, March, 2001 and Clin Pharmacol Ther 2001; 69: P57. 89. Lathia CD, Frye RF, Ferry S, Yeh S, Sundaresan PR. Evaluation of CYP3A, CYP2C9, and CYP2C19 enzyme induction in very early Phase I studies. Presented at the annual meeting of the American Society for Clinical Pharmacology and Therapeutics, Orlando, FL, March, 2001 and Clin Pharmacol Ther 2001; 69: P55. 90. *Lee JI, Pauli M, Chaves-Gnecco D, Amico JA, Kroboth PD, Frye RF. Application of the semi- simultaneous bioavailability approach to CYP3A phenotyping with midazolam. Presented at the American Society for Clinical Pharmacology and Therapeutics, Orlando, FL, March, 2001 and Clin Pharmacol Ther 2001; 69: P39. 91. Jung LL, Zamboni WC, Frye RF, Johnson CS, Adedoyin A, Hofacker JK, Branch RA, and Trump DL. Modulation of all-trans-retinoic Acid (ATRA) disposition with ketoconazole and disulfiram in patients with hormone-refractory prostate cancer. Presented at the American Society for Clinical Oncology Annual Meeting, May 2001. 92. Palevesky PM, Frye RF, Matzke GR. Effect of dialyzer reprocessing on the clearance of low and intermediate molecular weight solutes. Thirty-fourth Annual meeting of the American Society of Nephrology. San Francisco, CA. October 2001, and J Am Soc Nephrol 2001. 93. Carson SW, Hill-Zabala CE, Hoyler SL, Kotlyar M, Frye RF, Golding M. Acute and chronic effects of St. John’s wort (Hypericum Perforatum) on cytochromes P450 enzyme activity in healthy volunteers. Presented at the 2001 Annual meeting of the American College of Clinical Pharmacy, Tampa, FL. 94. Bolcato CA, Frye RF, Zemaitis MA, Poloyac SM. Cytochrome P450 mediated bioactivation of arachidonic acid in rat and human brain. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, Denver, CO, October 2001. 95. *Alkharfy KM, Poloyac SM, Frye RF. Effect of the acute-phase response on in vivo UGT activity in rats. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, Denver, CO, October 2001. 96. Lee CR, Pieper JA, Frye RF, Hinderliter AL, Blaisdell JA, Goldstein JA. Consequences of CYP2C9 polymorphisms on flurbiprofen pharmacokinetics. Presented at the American Society for Clinical Pharmacology and Therapeutics, Atlanta, GA, March 2002 and Clin Pharmacol Ther 2002; 71: 62. 97. Lee CR, Pieper JA, Frye RF, Hinderliter AL, Blaisdell JA, Goldstein JA. Assessment of CYP2C9 phenotypic:genotypic relationships with potential probes. Presented at the American Society for Clinical Pharmacology and Therapeutics, Atlanta, GA, March 2002 and Clin Pharmacol Ther 2002; 71: 25. 98. Kroboth PD, Amico JA, Stone RA, Folan MM, Frye RF, Kroboth FJ, Bigos KL, Fabian TJ, Linares AM, Pollock BG, Hakala C. Influence of oral DHEA administration on 24-Hour cortisol concentrations in older women and men. 42nd Annual NCDEU Meeting, Boca Raton, FL, June 2002. 99. Matzke GR, Palevsky PM, Frye RF. In-vitro assessment of influence of molecular weight on drug clearance by conventional and synthetic dialyzers. J Clin Pharmacol 2002; 42 (9): 85. 100. *Dix J, Weber RJ, Frye RF, Nolin TD, Mrvos R, Krenzelok E. Stability of atropine sulfate prepared for mass chemical terrorism. Presented at the North American Congress of Clinical Toxicology, September 2002. 101. Komoroski BJ, Zhang S, Cai HB, Hutzler JM, Frye RF, Tracy TS, Strom SC, Ang C, Cui YY, Venkataramanan R. The inductive effect of hyperforin (St. John’s wort) predominates over the inhibitory potential of hyperforin at physiological concentrations. Presented at the annual meeting of the International Society for the Study of Xenobiotics, October 2002. CV – Reginald F. Frye, Jr. Page 21

102. *Nolin TD, Bies RR, Gastonguay MR, Frye RF. A model for the simultaneous description of the pharmacokinetics of chlorzoxazone and its primary metabolite 6-hydroxychlorzoxazone after a single oral dose. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, Toronta, CA, November 2002. 103. Bolcato CA, Frye RF, Zemaitis MA, Poloyac SM. Quantification of 20-HETE, a vasoconstrictive cytochrome P450 metabolite of arachidonic acid, by high performance liquid chromatography/electrospray mass spectrometry. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, Toronta, CA, November 2002. 104. Elwell RJ, Frye RF, Ganchuk SR, Bailie GR. Pharmacokinetics of intraperitoneal cefepime in automated peritoneal dialysis. Presented at the Annual Dialysis Conference, Seattle, WA, March 2003. 105. Blowey DL, Warady BA, Manley HJ, Frye RF, Smith C. Vancomycin absorption after intraperitoneal administration in children receiving peritoneal dialysis. Presented at the American Society for Clinical Pharmacology and Therapeutics, Washington, DC, April 2003 and Clin Pharmacol Ther 2003; 73: P37. 106. Blowey DL, Warady BA, Manley HJ, Frye RF, Smith C. Pharmacokinetics of vancomycin in children receiving peritoneal dialysis. Presented at the American Society for Clinical Pharmacology and Therapeutics, Washington, DC, April 2003 and Clin Pharmacol Ther 2003; 73: P38. 107. *Nolin TD, Gastonguay MR, Bies RR, Matzke GR, Bernardo JF, Aslam N, Frye RF. Population pharmacokinetic model of chlorzoxazone and 6-hydroxychlorzoxazone in renal failure: impact of patient covariates on CYP2E1 activity. Presented at the American Society for Clinical Pharmacology and Therapeutics, Washington, DC, April 2003 and Clin Pharmacol Ther 2003;73: P80. 108. Frye RF, Chaves-Gnecco D, Matzke GR, Rabinovitz M, Shakil AO, Branch RA. Selective modulation of CYP-mediated metabolism in liver disease. Presented at the American Society for Clinical Pharmacology and Therapeutics, Washington, DC, April 2003 and Clin Pharmacol Ther 2003;73: P28. 109. *Hruska MW, Amico JA, Frye RF. Effect of CYP2C8 inhibition by trimethoprim on the pharmacokinetics of rosiglitazone. Presented at the American College of Clinical Pharmacology Annual Meeting, Tampa, FL, September 2003 and J Clin Pharmacol 2003;43:P1036. 110. Nicholas TM, Gastonguay MR, Sweeney KR, Nolin TD, Frye RF. Application of a map Bayesian method for CYP2E1 phenotyping. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, Miami, FL, March 2004 and Clin Pharmacol Ther 2004;75:P41. 111. Frye RF, *Fitzgerald SM, Lagattuta TF, Egorin MJ. Effect of St. John’s wort on imatinib mesylate pharmacokinetics. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, Miami, FL, March 2004 and Clin Pharmacol Ther 2004;75:P96. 112. Elwell RJ, Volino LR, Frye RF. Stability of Cefepime in Icodextrin Peritoneal Dialysis Solution. Presented at the 2004 Annual meeting of the American College of Clinical Pharmacy, Dallas, TX, October 2004 and Pharmacother 2004;24:1447. 113. Persky A, Moore K, Kim Y, Symonds W, Denning J, Frye RF. Effect of 695634, a Next Generation NNRTI, on Cytochrome P450 (CYP) Probe Substrates. Presented at the 2004 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Washington, DC, October 2004. 114. *Sivasubramanian R, Frye RF, Venkataramanan R. Components of valerian extracts and valerenic acid alter acetaminophen glucuronidation, in vitro. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, Baltimore, MD, November 2004. 115. Liu S, Frye R, Branch R, Venkataramanan R, Fung J, Burckart G. Changes in CYP450 enzyme activity over time following liver transplantation. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, Orlando, FL, March 2005 and Clin Pharmacol Ther 2005;77:P34. CV – Reginald F. Frye, Jr. Page 22

116. *Hruska MW, Cheong JA, Amico JA, Langaee TY, Frye RF. Effect of CYP2C8 genotype on rosiglitazone pharmacokinetics. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, Orlando, FL, March 2005 and Clin Pharmacol Ther 2005;77:P35. 117. *Hruska MW, Cheong JA, Langaee TY, Frye RF. Effect of St. John’s wort administration on CYP2C8 mediated rosiglitazone metabolism. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, Orlando, FL, March 2005 and Clin Pharmacol Ther 2005;77:P36. 118. *Sivasubramanian R, Frye RF, Venkataramanan R. Valerian does not alter acetaminophen glucuronidation. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, Nashville, TN, November 2005. 119. *Price E, Galloway CD, Frye RF. Development of a rapid method for the determination of rosiglitazone in human plasma by liquid chromatography tandem mass spectrometry in a 96-well format: application to pharmacokinetic studies. Presented at the 19th Annual Research Showcase, College of Pharmacy, University of Florida, February 2006. 120. Zgheib N, Frye R, Tracy T, Romkes M, Branch R. Validation of incorporating flurbiprofen into the Pittsbugh cocktail. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, Baltimore, MD, March 2006 and Clin Pharmacol Ther 2006;79:P46. 121. *Dravid P, Frye R. Quantitative determination of chlorzoxazone in human plasma and urine by LC/MS/MS: application to CYP2E1 phenotyping studies. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, San Antonio, TX, October 2006. AAPS Journal. 2006; 8(S2). Abstract W1063. 122. *Karnes J, Galloway C, Frye R. The influence of CYP2C9 polymorphisms on in vitro metabolism of repaglinide. Presented at the 20th Annual Research Showcase, College of Pharmacy, University of Florida, February 2007. 123. *Dravid P, Frye R. Determination of desethylamodiaquine by liquid chromatography tandem mass spectrometry: Application to cytochrome P450 2C8 studies in human liver microsomes. Presented at the 20th Annual Research Showcase, College of Pharmacy, University of Florida, February 2007. 124. *Nolin TD, Matzke GR, *Barker TJ, Frye RF. Effect of chronic kidney disease on Cytochrome P450 2C19 activity and 4-Hydroxymephenytoin urinary recovery. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, Anaheim, CA, March 2007 and Clin Pharmacol Ther 2007;81:S56. 125. Elewa HF, Kozak A, Rychly D, Ergul A, Frye RF, Fagan SC. Atorvastatin reduces intracerebral hemorrhage after experimental stroke. Presented at the American Heart Association Scientific Sessions 2007, Orlando, FL, November 2007. 126. *Dravid P, Frye R. Determination of Desethylamodiaquine by liquid chromatography tandem mass spectrometry: application to CYP2C8 metabolism studies in human liver microsomes. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, San Diego, CA, November 2007. AAPS Journal. 2007; 9(S2). Abstract W4056. Available from: http://www.aapsj.org/. 127. Nolin TD, Frye RF, Sadr H, Le P, Himmelfarb J. The pharmacokinetics of fexofenadine but not midazolam are altered in end-stage renal disease. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, Orlando, FL, April 2008 and Clin Pharmacol Ther 2008; (in press). 128. *Enogieru O, Pacanowski M, Frye RF, Zineh I. Changes in Coenzyme Q10 (CoQ10) Following High- Dose Atorvastatin Therapy. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, Orlando, FL, April 2008 and Clin Pharmacol Ther 2008; (in press). CV – Reginald F. Frye, Jr. Page 23

129. *Mohamed MF, *Harvey SS, Frye RF. Effect of ginkgo biloba and valerian root extracts on mycophenolic acid glucuronide formation in human liver microsomes. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, Orlando, FL, April 2008 and Clin Pharmacol Ther 2008; (in press). 130. Hastie BA, Stavropoulos MF, Frye RF, Wallace MR, Quintero LD, Tomalty S, Fillingim RB. Evidence for Response Differences in Acute Post-Operative Pain and Side Effects in a Multi-Ethnic Sample. American Pain Society's 27th Annual Scientific Meeting.

RESEARCH SUPPORT ∗ = active projects 1. Influence of aging on the expression of genetic polymorphic and non-polymorphic drug metabolism. Co- Investigator. John A. Hartford Foundation, 1990-1991. $10,000. 2. Impact of computerized pharmacokinetic forecasting on practitioner competency, kinetic consultation activity and patient outcome. Co-Investigator. Demonstration Projects Program. American Society of Hospital Pharmacists Research and Education Foundation, 1990-1991. $4,989. 3. The influence of type 1 and type 2 diabetes on the expression of genetic polymorphic drug metabolism. Co- Investigator. Diabetes Research and Education Foundation, 1990-1991. $19,935. 4. Burroughs Wellcome Clinical Pharmacokinetics Fellowship. Fellowship, Administered by the American Society of Hospital Pharmacists Research and Education Foundation, 1991-1993. $47,000. 5. An assessment of the fundamental relationships on which erythrokinetic modeling is based and the clinical utility of the model to guide intravenous and subcutaneous dosing of Epogen®. Co-Investigator. Amgen Clinical Grants Program, 1991-1993. $45,000. 6. A study to determine the effect of impaired renal function on the pharmacokinetics of abecarnil. Co- Investigator. Sandoz Research Institute, 1992-1993. $143,897. 7. Evaluation of a "cocktail strategy" to assess P450 isozyme-specific metabolic activity. Co-Principal Investigator. Upjohn Company (investigator-initiated research proposal), 1991-1992. $5,000. 8. Characterization of hepatic P450 isozyme activity in patients with various degrees of renal function. Co- Investigator. Harris Laboratories (investigator-initiated research proposal), 1992-1994. $24,000. 9. A study to determine the safety and pharmacokinetics of intravenous nalmefene in renally impaired patients. Co-Investigator, Ohmeda, Inc. 1993-1994. $58,756. 10. Effect of estrogen replacement therapy on liver metabolism in young and elderly postmenopausal women. Co-Investigator, National Institutes of Health 1993-1994. $19,440. 11. Nalmefene disposition in patients with mild, moderate, and severe hepatic dysfunction and healthy volunteers. Co-Investigator, Ohmeda, Inc. 1993-1994. $146,042. 12. Determination of the effect of 1.25 MAC desflurane on antipyrine pharmacokinetics in the beagle dog. Co- Investigator, Ohmeda, Inc., 1993-1994. $27,390. 13. Determination of nornalmafene concentrations after nalmefene dosing in normal subjects, subjects with moderate or severe hepatic dysfunction and subjects with renal disease. Co-Investigator. Ohmeda Pharmaceutical Products Inc. 1994. $34,087. 14. Sex hormones and P450 activity in women with liver disease. Principal Investigator, American College of Clinical Pharmacy Research Institute. 1995-96. $10,000. 15. Evaluation of cytochrome P450 inhibition by the chronic administration of disulfiram: effects on the disposition of chlorzoxazone and vesnarinone. Principal Investigator. Otsuka America Pharmaceuticals. 1995-97. $88,956. CV – Reginald F. Frye, Jr. Page 24

16. The effect of impaired enterohepatic recycling on the disposition of nalmefene and nalmefene glucuronide. Principal Investigator. Ohmeda Pharmaceutical Products Inc. 1996. $41,269. 17. Evaluation of the relationship of metabolic P450 activity and circulating plasma concentrations of vesnarinone and metabolites to the occurrence of neutropenia with vesnarinone. Principal Investigator. Otsuka America Pharmaceuticals. 1996. $31,226. 18. Drug disposition in transplant patients. Co-Investigator. (PI: Gilbert J. Burckart) NIDDK, National Institutes of Health. 1996-98. 19. DHEA & GABA-receptor mediated responses in aged adults. Co-Investigator. (PI: Patricia D. Kroboth) NIMH, National Institutes of Health. 1997-99. $685,528 TDC. 20. The effect of ritonavir on the pharmacokinetics and pharmacodynamics of alprazolam. Principal Investigator. Abbott Laboratories. 1997. 21. Pharmacokinetics of valacyclovir in solid organ transplant patients. Co-Investigator. (PI: Richard Ptachcinski). GlaxoWellcome (investigator-initiated research proposal). 1997. $35,181. 22. Evaluation of the predictive performance of EpoCalc pharmacodynamic modeling. Principal Investigator. Amgen. 1998. $9,400. 23. Evaluation of hepatic and renal function in patients participating in OAPI 103-96-205. Principal Investigator. Otsuka America Pharmaceuticals. 1998. $12,500. 24. In vitro metabolism/drug interaction and human clinical drug studies. FDA contract. Co-investigator (Principal investigator Robert A. Branch, M.D.) 9/97 – 11/99. $103,500. 25. Effects of citric acid/heat and peracetic acid reprocessing on the in vitro performance of polysulfone dialyzers. Co-Investigator. (PI: Paul Palevsky, M.D.). Veterans Administration Stars and Stripes Pilot Project Fund. $49,994. 26. Effect of peracetic acid and formaldehyde reprocessing on the in vitro performance of cellulose acetate and polysulfone dialyzers. Co-Investigator. (PI: Paul Palevsky, M.D.). Dialysis Clinics, Inc., Paul Teschan Research Fund. $49,708. 27. Evaluation of the effect of SB 223412 on the metabolism of multiple cytochrome P450 substrates. Principal Investigator. SmithKline Beecham. 2000. $101,568. 28. A study to assess the effect of 1555U88 on probe drugs eliminated by cytochrome P450 enzymes in healthy volunteers. Principal Investigator. GlaxoWellcome. 2000. $39,244. 29. Preclinical pharmacological studies of antitumor and anti-HIV agents (N01). Co-investigator (6% effort; PI: Merrill Egorin, MD), National Cancer Institute, NIH. 12/01/00 - 12/31/02. TDC: $890,925 TC: $1,285,232. 30. Interventions Research Center for the Study of Late-Life Mood Disorders (Principal Investigator Charles F. Reynolds III, MD; R.F. Frye, Co-investigator, 5% effort (no salary), Psychopharmacology Core) 2 P30 MH 52247. TDC (years 6 – 10; 3/2000 – 2/2005): $5,432,131. TC: $8,121,693. 31. Drug Metabolizing Enzymes - Risk Factors in Bladder Cancer (R01). Co-investigator (20% effort; PI: Robert A. Branch, MD), National Cancer Institute, NIH. 07/01/01 - 06/30/05. TDC: $890,925 TC: $1,285,232. 32. In vitro studies of the effects of St. John’s wort on the metabolism of docetaxel. Co-investigator (5% effort; PI: Merrill Egorin, MD). Rhone Poulenc Rhorer (RPR) Grant-in-aid. 07/01/02 – 06/30/03. TDC: $91,187 TC: $113,984. 33. Drug metabolism in chronic liver disease (R01). Co-investigator (15% effort; PI: Robert A. Branch, MD), National Institute of General Medical Sciences, NIH. 09/15/02 - 09/14/07. TDC: $1,296,315, TC: $1,934,334. CV – Reginald F. Frye, Jr. Page 25

34. St. John’s wort and CYP3A metabolism in Men & Women (R01). Principal Investigator (20% effort). National Institute of Mental Health, NIH. 05/01/2001 – 04/30/2005. TDC: $650,000, TC: $1,001,292. 35. Mechanisms of atypical drug kinetics and interactions (R01). Co-investigator (10% effort; PI: Timothy S. Tracy, PhD, West Virginia University), National Institute of General Medical Sciences, NIH. 07/01/2001 - 06/30/05. TDC: $625,000. University of Pittsburgh subcontract: TDC: $83,612, TC: $125,000. University of Florida subcontract TDC: $34,483, TC: $50,000. 36. Effect of St. John’s wort on Gleevec Pharmacokinetics. Principal Investigator. Novartis Investigator Initiated Research Program. 12/2002 – 06/2004. $59,960. 37. A Double-Blind, Parallel, Randomized, Placebo-Controlled, Ascending Repeat-Dose Study to Investigate GW695634X and GW678248X Safety, Tolerability and Pharmacokinetics following Oral Administration of GW695634G to Healthy Subjects for 10 Days. Principal Investigator. GlaxoSmithKline. 10/04 – 12/05. $54,960. 38. Effect of BAY 43-9006 on CYP3A activity in patients with advance refractory cancer. Principal Investigator (consulting and analytical services). GlaxoSmithKline. 12/04 – 12/05. $28,056. 39. Effect of Kidney Disease on CYP3A Metabolism and P-glycoprotein Transport. Co-investigator (PI: Dr. Thomas Nolin), 07/05 – 06/07. $130,000. 40. A Phase I, Single-Center, Open-Label, Multiple-Probe Drug Interaction Study to Determine the Effects of GW823093 on the metabolism of CYP450 Probe Substrates in Healthy Subjects (GSK Study 102875). Principal Investigator. GlaxoSmithKline. 8/05 – 2/07. $135,476. 41. 1K01NS055094; NIH/NIDDS; (PI Hastie). Ethnic Differences in Acute Pain and Analgesic Response. Co-Mentor. 04/06 – 03/11.*

PRESENTATIONS The Role of Drug Metabolizing Enzymes in Chemical Carcinogenesis. University of Pittsburgh, School of Pharmacy, February 1992. Pharmacokinetics and Pharmacodynamics of Torsemide, a potent loop diuretic. University of Pittsburgh, School of Pharmacy, April 1993. Vancomycin Therapeutic Drug Monitoring: Dosing for a target level at a target time and fitting serum levels. Satellite Workshop on Bayesian Individualization of Drug Dosage Regimens, Nonparametric EM Population Pharmacokinetic Modeling, Modeling Drug Diffusion into Endocardial Vegetations, and Bacterial Killing Curves, Philadelphia, PA, May 1993. Erythrokinetic Modeling for the chronic hemodialysis patient. University of Pittsburgh, School of Pharmacy, January 1994. University of Arizona, School of Pharmacy, February 1994. Medical College of Virginia, March 1994. Characterization of In Vivo Drug Metabolizing Enzyme Activities: Validation of Chlorzoxazone as a Probe of CYP2E1 and a Cocktail to Assess Multiple Enzymes. University of Pittsburgh, June 14, 1995. Use of a cocktail strategy to assess drug and disease state effects on in vivo CYP450 activity. Abbott Laboratories, December 7, 1995. Methods to assess CYP activity in patients with renal disease. American Society of Clinical Pharmacology Renal Section Symposium: Research Methods for Renal Pharmacology. March 21, 1996. CYP activity in patients with varying degrees of renal function. Renal Grand Rounds, University of Pittsburgh. March 28, 1996. CV – Reginald F. Frye, Jr. Page 26

The Cytochrome P450 enzyme system: Alphabet Soup? Brigham & Women’s Hospital, Department of Pharmacy. May 9, 1996. Methods to assess in vivo cytochrome P450 activity. Brigham & Women’s Hospital, Department of Obstetrics and Gynecology. May 9, 1996. Mono-acetyldapsone disposition is altered in the presence of disulfiram. School of Pharmacy Seminar Series, University of Pittsburgh, February 20, 1997. Application of the “Pittsburgh Cocktail” approach to drug interaction studies. Presentation to visiting FDA scientific reviewers, Center for Clinical Pharmacology, June 1997. Assessment of in vivo CYP enzyme activity in humans. Center for Clinical Pharmacology, August 1997. Drug interactions with the protease inhibitor ritonavir. Center for Clinical Pharmacology Seminar Series, November 1997. A generalized approach for determining the potential for drug interactions in vivo. Presented at the 17th Annual Rozman Symposium on Drug Metabolism, Delaware Valley Drug Metabolism Discussion Group, Philadelphia, PA, May 1998. Clinical significance of cytochrome P450 (CYP) enzymes. Housestaff Patient Management Conference, Montefiore University Hospital, September 1998. Flurbiprofen and the Pittsburgh Cocktail: Should it stay or should it go now? Center for Clinical Pharmacology Seminar Series, December 1998. The Pittsburgh Cocktail Approach: A generalized approach for assessing drug and disease state effects on in vivo CYP activity. West Virginia School of Pharmacy, Morgantown, WV, March 1999. Effect of Congestive Heart Failure on drug metabolism: Relevance to cardiovascular pharmacotherapy. Cardiovascular Institute, University of Pittsburgh, April 1999. A generalized in vivo approach for determining the potential for drug-drug interaction. Presented at the Barnett International Conference: Predicting, Managing, and Understanding Drug-Drug Interactions. September 1999. A generalized in vivo approach for assessing drug and disease state effects on cytochrome P450 (CYP) enzymes. Senior Vice Chancellor’s Research Seminar Series. July 2000. Strategies for In Vivo Assessment of Drug Interaction Potential: Selection and Application of Probe Substrates. Presented at the 2nd Annual Barnett International Conference: Predicting, Managing, and Understanding Drug-Drug Interactions. October 2000. Interindividual Variability in Drug Response: Pharmacokinetics and Genetics. Presented at the Conference on Chronic Disorders: “Methodological Issues in Studies of Adherence” workshop sponsored by the University of Pittsburgh School of Nursing Center for Research in Chronic Disorders, October 2000. Drugs and Genes. University of Pittsburgh Discovery Weekend, School of Pharmacy, University of Pittsburgh. October 2000. Interindividual Variability in Response: Pharmacogenetic Determinants. University of Pittsburgh, School of Pharmacy. January 2001. Pharmacogenetics of Drug Metabolism. Molecular Therapeutics / Drug Discovery Seminar Series, University of Pittsburgh Cancer Institute. May 2001. Pharmacogenomics. GEAR-UP program, School of Pharmacy, University of Pittsburgh. February 2002. Characterization of Genetic and Non-Genetic Factors that affect Cytochrome P450-Mediated Metabolism In Vivo. College of Pharmacy, University of Florida, October 2002. CV – Reginald F. Frye, Jr. Page 27

New and Improved Methodologies for Measuring Drugs and Metabolites in Biological Fluids. ACCP Spring Practice and Research Forum, April 2003. Advances and Updates in Chromatography – Workshop. ACCP Spring Practice and Research Forum, April 2003. Application of Probe Drugs to Estimate In Vivo Activity of Drug Metabolizing Enzymes. 2003 Workshop, Advanced Methods of PK/PD Systems Analysis, sponsored by the Biomedical Simulations Resource, University of Southern California, June 2003. Selection and Application of Probe Substrates for Assessing Potential Drug-Drug Interactions In Vivo. 6th International Conference on Drug-Drug Interactions, sponsored by the Institute for Scientific Exchange, Inc. June 2003. Probing the World of Cytochrome P450 Enzymes. Center for Food-Drug Interaction Research and Education and Department of Pharmaceutics, University of Florida, February 2004. Variability in drug response: Herbs, SNPs, and CYPs. College of Pharmacy Faculty Research Forum, University of Florida, May 2004. Herb-Drug Interactions. 55th Annual Wisconsin Pharmacy Institute: An Update on Herbal and Nutritional Therapies. University of Wisconsin, Madison, WI, November 2004. In vivo evaluation of CYP activity: Clinical Implications of genetic polymorphism. AAPS short course: An update on Cytochrome P450 (CYP450). AAPS Annual Meeting, Baltimore, MD, November 2004. Effect of CYP2C8 Pharmacogenetics and Drug Interactions on Rosiglitazone Pharmacokinetics. Department of Pharmacy Practice, College of Pharmacy, University of Florida, April 2005. Effect of Chronic Kidney Disease on the Drug Metabolism Phenotype. Department of Pharmacy Practice, College of Pharmacy, University of Florida, March 2006. Effect of Aging on Cytochrome P450-mediated Metabolism. Institute on Aging Research Seminar Series, College of Medicine, University of Florida, March 2006. Clinical Pharmaceutical Sciences at the University of Florida. Clinical Scientist Task Force Open Hearing, American Association of Colleges of Pharmacy Annual Meeting, San Diego, July 2006. Effect of disease and inflammation on cytochrome P450 mediated metabolism in man. Drug Metabolizing Enzymes and Disease Pathogenesis Symposium, AAPS Annual Meeting, San Antonio, TX, November 2006. Pharmacogenetics and Drug Abuse Research. Interdisciplinary Drug Abuse Research Group Seminar Series, University of Florida, February 2007. Effect of genotypic variation on CYP2C8 phenotype. DMET Forum, Affymetrix, Santa Clara, CA, March 2007. Pharmacogenetic and environmental factors that alter human drug metabolism. Invited Distinguished Alumni Speaker, Oglethorpe Symposium, Oglethorpe University, Atlanta, GA, April 2007. Variability in drug metabolism: Interactions, SNPs, and CYPs. Keynote Speaker, School of Pharmacy Research Day, University of Iowa, April 2007. Role of Pharmacogenetics in Primary Care. The New Drug Update, Continuing Education Symposium, Medical University of South Carolina, Charleston, SC, May 2007. Mechanisms and Assessment of Drug Interactions Involving Metabolic Enzymes. ACCP Annual Meeting, Curricular Track 4 – Approach to Complex Drug Interactions: Clinical and Research Applications. Denver, CO, October 2007. Veronika Butterweck, PhD

Office: College of Pharmacy Phone: 352-846-2470 Department of Pharmaceutics Fax: 352-392-4447 1600 SW Archer Road, Room P3-31 [email protected] Gainesville, FL 32610

Home: 5333 SW 75th Street, Apt. 195 Gainesville, FL 32608 Phone: +1-352-377-7825

CITIZENSHIP: German

DATE OF BIRTH: 04/16/1968

POSITION HELD: since September 2003 Assistant Professor at the Department of Pharmaceutics, College of Pharmacy, University of Florida

EDUCATION: July 2003 – Habilitation (venia legendi for pharmacology) Westfälische Wilhelms-Universität, Münster, Germany

July 1997 – PhD degree Westfälische Wilhelms-Universität, Münster, Germany • Thesis title: Pharmacological and phytochemical investigations of Hypericum perforatum L. (Hypericaceae) and its active constituents

Janary 1994 – July 1997 - PhD student Institute of Pharmacology and Toxicology. This work was in cooperation with the Institute of Pharmaceutical Biology and Phytochemistry, Westfälische Wilhelms-Universität, Münster, Germany. • Supervisor: Prof. Dr. Hilke Winterhoff and Prof. Dr. Adolf Nahrstedt • Techniques: behavioural pharmacology, drug administration, radioimmuno assays, phytochemical techniques: HPLC, MLCCC, isolation of compounds

December 1993 – licensed in Germany as a pharmacist

October 1992 – December 1993 - Residency in pharmacies • Ungerer-Bad Apotheke, München, Germany

CV - page 1 • Sonnen Apotheke, Brilon, Germany

October 1988 – October 1992 Study of Pharmaceutical Sciences Westfälische Wilhelms-Universität, Münster, Germany

POSTDOCTORAL EXPERIENCE: August 1998 to August 2003 – Institute of Pharmacology and Toxicology Westfälische Wilhelms-Universität, Münster, Germany • Supervisor: Prof. Dr. Hilke Winterhoff • Focus: Pharmacological, endocrinological and biochemical investigations of St. John’s wort and its active constituents, Antidepressant activity of Apocynum venetum, investigation of Kava-Kava in animal models of alcohol dependency • Techniques: small animal surgery , in vivo animal models (psychotropic and neurotropic activity, animal models of alcoholism), isolation of discrete brain regions, HPLC – electrochemical and fluorescent detection, radioimmuno assays, receptor binding assays

May 1999 – December 1999 & January 2001 – July 2001 – National Institute of Mental Health Bethesda, Maryland, USA • Supervisor: Dr. Miles Herkenham • Focus: Influence of St. John’s wort on the hypothalamic- pituitary- adrenal (HPA) axis • Techniques: in vivo animal models include immobilization stress, in situ hybridization, basic histology, RNA isolation and quantitation, densitometry, light microscopy and photography

INDUSTRIAL EXPERIENCE: January 1999 - December 2000 • Cooperative Research • Lichtwer Pharma AG, Berlin, Germany • Project: Investigations on the mode of action of St. John’s wort

September 2003 - present • Cooperative Research and Development Agreement • Steigerwald Arzneimittel, Darmstadt, Germany • Project: Investigations on the mode of action of St. John’s wort

January 2004 – December 2004 • Cooperative Research and Development Agreement • Pascoe Pharmaforschung, Giessen, Germany • Project: Antidepressant activity of Neurapas, a combination of Passionflower, St. John’s wort and Valerian root

CV - page 2 January 2004 – present • Cooperative Research and Development Agreement • Tokiwa Phytochemicals, Chiba, Japan • Project: Antidepressant activity of Apocynum venetum in animal models

January 2005 – December 2005 • Cooperative Research and Development Agreement • Finzelberg GmbH, Andernach, Germany • Project: Screening of medicinal plant with hypouricemic activity

January 2005 – present • Cooperative Research and Development Agreement • Max Zeller AG, Romanshorn, Switzerland • Project: Sleep inducing properties of hops extract

July 2006 - present • Cooperative Research and Development Agreement • Steigerwald Arzneimittel, Darmstadt, Germany • Project: Anti-stress effects of St. John´s wort extracts

ACADEMIC COLLABORATIONS: January 2000 to July 2003 • PD Dr. Markus Schwaninger, Clinic of Neurology, Ruprecht-Karls-University of Heidelberg, Germany • Project: Role of Interleukin-6 in stressed induced hyperthermia and emotional behaviour in mice

April 2000 to April 2003 • Prof. Dr. Adolf Nahrstedt • Institute of Pharmaceutical Biology and Phytochemistry, Münster, Germany • Project: Studies on the bioavailability of hypericin

June 2000 to present • Prof. Dr. Sansei Nishibe, Faculty of Pharmaceutical Sciences, Health Sciences University of Hokkaido, Ishikari-Tobetsu, Hokkaido, Japan • Project: Pharmacological and phytochemical investigations on Apocynum venetum L.

January 1999 to December 2001 • Prof. Dr. Bryan Roth, Case Western Reserve University, Cleveland, Ohio, USA • Project: In vitro receptor screening of pure constituents of St. John’s wort (funded by the NIMH Psychoactive Drug Screening Program)

AWARDS:

1998 Rudolf Fritz Weiss Award of the Society of Phytotherapy 2002 Phoenix Scientific Award for the Section Pharmacognosy

CV - page 3

HONORS: 2005 Member of the Expert Committee Dietary Supplements / Botanicals of the United States Pharmacopoeia (USP)

Further Qualifications / Titles:

2000 Title: “Fachpharmakologin Deutsche Gesellschaft für experimentelle und klinische Pharmakologie und Toxikologie (DGPT) (= Certified Expert in Pharmacology)

PATENTS: Apocynum venetum extract for use as an antidepressant. Patent Number 6737085, Assignee: Tokiwa Phytochemical Co., Ltd, Chiba, Japan.

TEACHING EXPERIENCE: October 2001 – July 2003 • Teaching classes and seminars for students of pharmaceutical sciences, Westfälische Wilhelms-University, Münster, Germany:

Topics: - Immune system - Blood - Hormones of the pituitary and thyroid - Insulin - Design and quality of clinical studies - Problem based learning (case reports)

April 2000 – July 2003 • Teaching classes and seminars for students of medicine, Westfälische Wilhelms- University, Münster, Germany:

Topics: - Drugs affecting the central nervous system - Diuretic drugs - Drugs affecting the cardiovascular system - Toxicology of heavy metals - Therapy with phytomedicines - Problem based learning (case reports)

May 1995 – July 1996 • Teaching classes for geriatric nurses, Diakonissenmutterhaus, Münster, Germany

Topics: - Absorption, distribution and elimination of drugs - Pharmacokinetic and drugs receptors - Chemotherapeutic drugs

CV - page 4 April 2003 - present • Herbal Medicines Class: Quality, Safety and Efficacy of Herbal Medicinal Products, Required Class for Pharmacy students (4th year), College of Pharmacy, University of Florida • Phytopharmaceutics: Pharmacognosy and Biochemistry of Natural products; Elective Class for Graduate students, College of Pharmacy, University of Florida

Further teaching experiences: - Duties included laboratory lectures, supervision of PhD-students, technical assistants

Editorial Board

• Planta Medica (Co-Editor)

REVIEWER ACTIVITIES

• Planta Medica • Journal of Psychiatric Research • Pharmacopsychiatry • Hormone and Metabolic Research • Progress in Neuro-Psychopharmacology & Biological Psychiatry • Journal of Ethnopharmacology • Journal of Pharmacy and Pharmacology • Neurochemistry International • Journal of Pharmacological Research

PROFESSIONAL ASSOCIATIONS: • Society for Neuroscience • Society of Medicinal Plant Research (Gesellschaft für Arzneipflanzenforschung) • Deutsche Pharmazeutische Gesellschaft (German Pharmaceutical Society) • Gesellschaft für Phytotherapy (Society of Phytotherapy) • Deutsche Gesellschaft für experimentelle und klinische Pharmakologie and Toxikologie (German Society of experimental and clinical Pharmacology and Toxicology) • American Society of Pharmacognosy

Administrative Duties: Co-director of the Center for Food-Drug Interaction, Research & Education, University of Florida, Gainesville, USA

CV - page 5 Papers published

Books

1. Pharmakologische Untersuchungen zur antidepressiven Wirkung von Hypericum perforatum L. WINTERHOFF, H., BUTTERWECK, V., NAHRSTEDT, A., GUMBINGER, H.G., SCHULZ, V., ERPING, S., BOSSHAMMER, F., WIELIGMANN, A. In: LOEW, D., RIETBROCK, N., Phytopharmaka in Forschung und klinischer Anwendung, Steinkopff Verlag, Darmstadt, pp. 39-56 (1995)

2. Pharmacokinetics of Herbal Products BUTTERWECK, V., DERENDORF, H. In: FRANCIS LAM, Y.W., HUANG, S.M., HALT, S.D., Herbal Supplement-Drug Interactions Taylor and Francis, New York pp 205-244 (2006)

3. Drug-Interactions of Grapefruit- and Other Citrus- Polyphenolics – What have we learned? MERTENS-TALCOTT, S.U., ZDROJEWSKI. I., DE CASTRO, W.V., BUTTERWECK, V., DERENDORF, H. In: FRANCIS LAM, Y.W., HUANG, S.M., HALT, S.D., Herbal Supplement-Drug Interactions Taylor and Francis., New York, pp 147-190 (2006)

Papers

1. Effects of the total extract and fractions of Hypericum perforatum in animal assays for antidepressant activity BUTTERWECK, V., WALL, A., LIEFLAENDER-WULF, U., WINTERHOFF, H., NAHRSTEDT, A., Pharmacopsychiatry, 30, 117-124, Suppl.2 (1997)

2. Biologically active and other chemical constituents of the herb of Hypericum perforatum NAHRSTEDT, A., BUTTERWECK, V. Pharmacopsychiatry, 30, 129-134, Suppl. 2 (1997)

3. Solubilized hypericin and pseudohypericin from Hypericum perforatum L. exert antidepressant activity in the forced swimming test BUTTERWECK, V., PETEREIT, F., WINTERHOFF, H., NAHRSTEDT, A. Planta Medica, 64, 291-294 (1998)

4. Flavonoids from Hypericum perforatum show antidepressant activity in the forced swimming test BUTTERWECK, V., JUERGENLIEMK, G., NAHRSTEDT, A., WINTERHOFF, H. Planta Medica, 66, 3-6 (2000)

5. Pharmacological and endocrine effects of Hypericum perforatum and hypericin after repeated treatment BUTTERWECK, V., KORTE, B., WINTERHOFF, H. Pharmacopsychiatry, 34 (Suppl. 1), S2-S7 (2001)

CV - page 6

6. St. John’s wort, hypericin, and imipramine: a comparative analysis of mRNA levels in brain areas involved in HPA axis control following short-term and long-term administration in normal and stressed rats BUTTERWECK, V., WINTERHOFF, H., HERKENHAM, M. Molecular Psychiatry, 6, 547-564 (2001)

7. Antidepressant effects of Apocynum venetum leaves in the forced swimming test BUTTERWECK, V., NISHIBE, S., SASAKI, T., UCHIDA, M. Biol. Pharm. Bull., 24, 7, 848-851 (2001)

8. Long-term effects of St. John’s wort and hypericin on monoamine levels in rat hypothalamus and hippocampus BUTTERWECK, V., BÖCKERS, T., KORTE, B., WITTKOWSKI, W., WINTERHOFF, H. Brain Res., 930, 21-29 (2002)

9. In vitro receptor screening of pure constituents of St. John’s wort reveals novel interactions with a number of GPCRs BUTTERWECK, V., NAHRSTEDT, A., EVANS, J., HUFEISEN, B., ERNSBERGER, P., ROTH, B.L. Psychopharmacology, 162, 193-202 (2002)

10. Pharmakologische und klinische Untersuchungen zum Einsatz von Cimicifuga racemosa bei klimakterischen Beschwerden WINTERHOFF, H., BUTTERWECK, V., JARRY, H., WUTTKE, W. Wien. Med. Wschr. 152, 360 – 363 (2002)

11. Mechanism of action of St. John’s wort in depression: What is known? BUTTERWECK, V., Review, CNS Drugs, 17 (8), 539-562 (2003)

12. Plasma levels of hypericin in presence of procyanidin B2 and hyperoside: A pharmacokinetic study in rats BUTTERWECK, V., LIEFLÄNDER-WULF, U., WINTERHOFF, H., NAHRSTEDT, A. Planta Medica, 69 (3), 189-192 (2003)

13. Cimicifuga extract BNO 1055: Reduction of hot flushes and hints on antidepressant activity WINTERHOFF, H., SPENGLER, B., CHRISTOFFEL, V., BUTTERWECK, V., LÖHNING, A. Maturitas, 44 (Suppl. I), S51-S58 (2003)

14.Step by step removal of hyperforin and hypericin: Activity profile of different Hypericum preparations in behavioural models BUTTERWECK, V., CHRISTOFFEL, V., NAHRSTEDT, A., PETEREIT, F., SPENGLER, B., WINTERHOFF, H. Life Sciences, 73 (5), 627-639 (2003)

15. Hypericum Review : Phytochemie und Pharmakologie des Johanniskrautes. Was ist bekannt? BUTTERWECK, V., NAHRSTEDT, A. Pharmazie in unserer Zeit, 32 (3), 212-219 (2003)

CV - page 7 16. Long-term effects of an Apocynum venetum extract on brain monoamine levels and β-AR density in rats BUTTERWECK, V., SIMBREY, K., SEO, S., SASAKI, T., NISHIBE, S. Journal of Biochemistry, Pharmacology and Behavior, 75(3), 557-564 (2003)

17. The role of IL-6 in stress induced hyperthermia and emotional behaviour in mice BUTTERWECK, V., PRINZ, S., SCHWANINGER, M. Behavioural Brain Research, 144 (1-2), 49-56 (2003)

18. Hyperforin fails to affect gene transcription in brain areas involved in HPA axis control BUTTERWECK, V., WINTERHOFF, H., HERKENHAM, M. Neuropsychopharmacology, 28, 2160 – 2168 (2003)

19. Different extracts of St. John’s wort and various constituents affect β-adrenergic binding in rat frontal cortex SIMBREY, K., WINTERHOFF, H. BUTTERWECK, V. Life Sciences, 74, 1027 – 1038 (2004)

20. An update on the treatment of thyroid disease BUTTERWECK, V. Drug Topics, 4, 93 – 102 (2004)

21. Pharmacokinetic herb-drug interactions: Are preventive screenings necessary and appropriate? BUTTERWECK, V., DERENDORF, H., GAUS, W., NAHRSTEDT, A., SCHULZ, V., UNGER, M. Planta Medica 70 (9), 784 - 791 (2004)

22. Flavonoids of St. John’s wort reduce HPA-axis function in rats BUTTERWECK, V., HEGGER, M., WINTERHOFF, H. Planta Medica 70 (10), 1008 – 1011 (2004)

23. Apocynum venetum extract does not induce CYP3A and P-glycoprotein in rats KOBAYASHI, M., SAITOH, H., SEO, S., BUTTERWECK, V., NISHIBE, S. Biol Pharm Bull 27 (10), 1649 – 1652 (2004)

24. Effects of forced swimming stress on rat brain function. SAKAKIBARA, H., ISHIDA, K., MINAMI, Y, SAITO, S., BUTTERWECK, V., TAMAKI, T., NAKAYA, Y., TERAO, J. J Med Invest. 52 Suppl: 300-1 (2005)

25. Variation of Flavonoids and Furanocumarins in Grapefruit Juices DE CASTRO, W.V., MERTENS-TALCOTT, S., RUBNER, A., BUTTERWECK, V., DERENDORF, H. J Agricul Food Chem 54(1):249-55 (2006)

26. Antidepressant effect of extracts from Ginkgo biloba leaves in behavioral models SAKAKIBARA, H., ISHIDA, K., GRUNDMANN, O., NAKAJIMA, J., SEO, S., BUTTERWECK, V., MINAMI, Y., SAITO, S., KAWAI, Y., NAKAYA, Y., TERAO, J.

CV - page 8 Biol Pharm Bull 29(8): 1767-70 (2006)

27. Isolation and HPLC quantitative analysis of antioxidant flavonoids from Alternanthera tenella Colla. SALVADOR, M.J., FERREIRA, E.O., MERTENS-TALCOTT, S.U., DE CASTRO, W.V., BUTTERWECK, V., DERENDORF, H., DIAS, D.A. Z Naturforsch 61(1-2): 19-25 (2006)

28. Hyperforin in St. John´s wort drug interactions MADABUSHI, R., FRANK, B., DREWELOW, B., DERENDORF, H., BUTTERWECK,V. Eur J Clin Pharmacol 62(3): 225-33 (2006)

29. Effects of St. John’s wort extract and isolated compounds on stress-induced hyperthermia in mice GRUNDMANN, O., KELBER, O., BUTTERWECK, V. Planta Medica 72(15): 1366-72 (2006)

30. Anxiolytic activity of Apocynum venetum extract in the elevated plus maze in mice O.GRUNDMANN, J. NAKAJIMA, S.SEO., V.BUTTERWECK J Ethnopharmacol 110(3): 406-11 (2006)

31. Grapefruit-drug interactions: can interactions with drugs be avoided? MERTENS-TALCOTT, S., ZADEZENSKY, I., DE CASTRO, W.V., DERENDORF, H., BUTTERWECK, V. J Clin Pharmacol. 46(12):1390-416 (2006)

32. Hypothermic effects of hops are antagonized with the competitive melatonin receptor antagonist luzindole in mice. BUTTERWECK, V., BRATTSTROEM, A., GRUNDMANN, O., KOETTER, U. J Pharm Pharmacol 59: 549-52 (2007)

33. MERTENS-TALCOTT, S., DE CASTRO, W.V., MANTHEY, J.A., DERENDORF, H., BUTTERWECK, V. Polymethoxylated flavones and other phenolic derivates from citrus in their inhibitory effects on P- glycoprotein-mediated transport of talinolol in Caco-2 cells. J Agric Food Chem. 55(7):2563-8 (2007)

Lectures

1. The solubility-dependent antidepressant activity of hypericin and pseudohypericin in the rats forced swimming test BUTTERWECK, V., NAHRSTEDT, A., WINTERHOFF, H. Lecture: International Symposium on Bioassay Methods in Natural Product Research and Drug Development, Biomedical Centre, Uppsala University, Sweden 24.-27.8.1997

2. Solubilized hypericin and pseudohypericin with antidepressant activity in the forced swimming test from Hypericum perforatum L. BUTTERWECK, V., PETEREIT, F., NAHRSTEDT, A., WINTERHOFF, H. Short lecture at the 45th Annual Meeting of the Society of Medicinal Plant Research in Regensburg, Germany, 7. – 12. September 1997

CV - page 9

3. Effects of acute and chronic Hypericum extract and hypericin administration in the rat brain: in situ hybridization studies BUTTERWECK, V. Lecture: Symposium ‘Pharmacology of St. John’s wort (Hypericum perforatum L.) and its constituents, Frankfurt, Germany, February 20th – 22nd, 2000

4. Neuroendocrinological investigations after short-term and chronic treatment with St. John’s wort and hypericin BUTTERWECK, V., KORTE, B., WINTERHOFF, H. Short-lecture: at the 3rd International Congress on Phytomedicine, Munich, Germany, October 11 - 13, 2000 Organized by the Society of Phytotherapy, the Society for Medicinal Plant Research, and the European Scientific Cooperative on Phytotherapy (ESCOP)

5. Selective effects of long-term administration of St. John’s wort and hypericin on gene expression in brain areas involved in HPA axis control BUTTERWECK, V., WINTERHOFF, H., HERKENHAM, M. Lecture: at the Annual Meeting of the Society of Biological Psychiatry, New Orleans, USA, May 3-7, 2001 6. St. John’s wort: a herbal mood buster? BUTTERWECK, V. Lecture: Post-Doc Meeting at the National Institutes of Mental Health, Bethesda, USA, July 15th, 2001

7. Antidepressant effects of Apocynum venetum leaves in the forced swimming test BUTTERWECK, V., NISHIBE, S., SASAKI, T., UCHIDA, M. Lecture: at the 49th Annual Meeting of the Society for Medicinal Plant Research, Erlangen, Germany, September 2-6, 2001

8. Antidepressant Activity of St. John’s wort in animal models of depression BUTTERWECK, V. Lecture: Department of Agriculture, University of Tokio, Japan, March 18th, 2002

9. St. John’s wort: A possible strategy to examine the CNS activity of plant extracts BUTTERWECK, V. Lecture: Department of Pharmaceutics, University of Florida, Gainesville, USA, July 8th, 2002

10. A lipophilic extract of St. John’s wort and hyperforin-trimethoxybenzoate fail to attenuate gene transcription in brain areas involved in HPA axis control BUTTERWECK, V., WINTERHOFF, H., HERKENHAM, M. Lecture: Annual Meeting of the German Society of Phytotherapy, Berlin, Germany, October 10 – 12th, 2002

11. Hypouricemic activity of an extract of Gundelia tournefortii L. BUTTERWECK, V.,LECHTENBERG, M., QUANDT, B., NAHRSTEDT A., QUADAN, F.Lecture: at the 51st Annual Meeting of the Society for Medicinal Plant Research, Kiel, Germany, September 1-3, 2003

12. Interaktionen pflanzlicher Arzneimittel: Möglichkeiten der Prüfung und klinische Relevanz BUTTERWECK, V. Lecture: Phytopharmaka Symposium, Goslar, Germany, March 24 – 25th, 2004

CV - page 10 13. Apocynum venetum L. – A novel herbal antidepressant BUTTERWECK, V., KIPKE, S., NAHRSTEDT, A. Lecture: Chiba University, Department of Agriculture, Chiba, Japan, June 15th, 2004

14. Anti-stress effects of selected herbal medicines BUTTERWECK, V. Lecture: Tokushima University, Institute of Psychology, Tokushima, Japan, September 1st, 2004

15. Apocynum venetum L. – A new herbal mood booster BUTTERWECK, V. Lecture: SupplySide West, International Trade Show and Conference, Las Vegas, USA, September 29th- October 1st 2004

16. Herbal approaches to malignant diseases BUTTERWECK, V. Joint Cancer Conference of the Florida Universities, Orlando, USA, January 27th – 29th 2005

17. Mechanisms of drug-nutrient interactions BUTTERWECK, V. American Pharmacists Association, Orlando, USA, April 1st – 3rd 2005

18. Natural Products as causes of drug-interactions BUTTERWECK, V. Lecture: International Congress of the European Society of Clinial Pharmacology, Poznan, Poland June 26 – 29th, 2005

19. Hypericum perforatum as a modern antidepressant : Active compounds and quality BUTTERWECK, V. Lecture: 53rd Meeting of the Polish Herbal Committee, Poznan, Poland June 25 – 26th, 2005

20. Effects of St. John’s wort extract and single compounds on stress-induced hyperthermia in mice GRUNDMANN, O., KELBER, O., BUTTERWECK, V. Lecture: 53rd Annual Meeting of the Society of Medicinal Plant Research, Florence, Italy August 21st – 26th, 2005

21. Depression, Anxiety and New Herbal Research BUTTERWECK, V. Lecture: Supply Side West, International Trade Show and Conference, Anaheim, USA, March 26th – 29th, 2006

22. Commonly used Herbal Medicines BUTTERWECK, V. Lecture: Mayo Clinic Jacksonville, USA, May 21st, 2006

23. Effects of St. John’s wort extract and single compounds on stress-induced hyperthermia in mice GRUNDMANN, O., KELBER, O., BUTTERWECK, V.

CV - page 11 Lecture: 47th Annual Meeting of the Society American Society of Pharmacognosy, Arlington, VA, August 5th – 9th 2006

24. Grapefruit Juice Drug Interactions: grapefruit juice and its components inhibit P-glycoprotein mediated transport of talinolol in Caco-2 Cells DE CASTRO, W.V., MERTENS-TALCOTT, S.U., DERENDORF, H., BUTTERWECK, V. Lecture: 54th Annual Meeting of the Society of Medicinal Plant Research, Helsinki, Finland August 29st – September 2nd, 2006

25. Evaluation of Grapefruit Juice and its components on P-glycoprotein activity BUTTERWECK, V., DE CASTRO, W.V., DERENDORF, H. Lecture: Experimental Biology Annual Meeting, section: PHENRIG, Washington DC, USA, April 28th – May 2nd, 2007

Poster presentations

1. Changes in body temperature of mice give evidence for central effects of Hypericum perforatum L. WALL, A., BUTTERWECK, V., WINTERHOFF, H., GUMBINGER, H.G., NAHRSTEDT, A. Posterpresentation on the 43th Annual Meeting of the Society of Medicinal Plant Research (GA) Halle, Germany, 3.-7. September, 1995

2. Preparations from Hypericum perforatum L. interfere with the ketamine-induced sleeping time in mice BUTTERWECK, V., WINTERHOFF, H., GUMBINGER, H.G., NAHRSTEDT, A. Posterpresentation on the 43th Annual Meeting of the Society of Medicinal Plant Research (GA) Halle, Germany, 3.-7. September, 1995

3. Effects of Hypericum perforatum L., in animal models of depression were counteracted by dopamine- receptor antagonists BUTTERWECK, V., NAHRSTEDT, A., WINTERHOFF, H., HÜBNER, W.D. Posterpresentation at the ESCOP-Symposium in Köln, Germany, 15.03.1996

4. An extract of Hypericum perforatum L. decreases immobility time of rats in the forced swimming test BUTTERWECK, V., WINTERHOFF, H., SCHULZ, V., NAHRSTEDT, A. Posterpresentation on the Annual Meeting of the American Chemical Society (ACS) in Orlando, USA, 25. – 29. August 1996

5. Isolation by MLCCC and NMR-spectroscopy of hypericin, pseudohypericin and I3,II8-biapigenin from Hypericum perforatum L. BUTTERWECK, V., PETEREIT, F., WINTERHOFF, H., WRAY, V., NAHRSTEDT, A. Posterpresentation on the 44th Annual Meeting of the Society of Medicinal Plant Research (GA) in Prague, 3. – 7. September 1996

6. Pharmacological in vivo testing of fractions obtained from Hypericum perforatum L.

CV - page 12 BUTTERWECK, V., WINTERHOFF, H., SCHULZ, V., NAHRSTEDT, A. Posterpresentation , 2nd International Congress on Phytomedicine and the 7th Congress of the German Society of Phytotherapy, Munich, Germany, 11.-14. September 1996

7. Neurotransmitter concentrations and endocrine parameters in rats following repeated treatment with extracts and isolated constituents from Hypericum perforatum L. BUTTERWECK, V., WINTERHOFF, H. Posterpresentation on the 39th. Annual Meeting of the German Society for experimental and clinical Pharmacology and Toxicology, Mainz,Germany, März 1998 Published: Naunyn-Schmiedeberg`s Archives of Pharmacology Suppl. 357 Nr. 4, R 100 (1998)

8. Effects of Hypericum perforatum extract and isolated constituents on neurotransmitter concentrations and endocrine parameters BUTTERWECK, V., NAHRSTEDT, A., WINTERHOFF, H. Posterpresentation at the 46th Annual Meeting of the Society of Medicinal Plant Research (GA) in Vienna, Austria, 31.08.-03.09.1998

9. Flavonoid-Fraktionen und Hyperosid aus Hypericum perforatum L. zeigen antidepressive Aktivität im Forced Swimming Test nach Porsolt BUTTERWECK, V., JÜRGENLIEMK, G., NAHRSTEDT, A., WINTERHOFF, H. Posterpresentation auf dem gemeinsamen Symposium der Gesellschaft für Arzneipflanzenforschung und der Gesellschaft für Phytotherapie, Bonn, 27. – 28. November 1998

10. Piper methysticum (Kava-Kava): Pharmacological investigations on the central activity KOHLENBERG, F.J., BUTTERWECK, V., VERSPOHL, E.J., WINTERHOFF, H. Posterpresentation on the 40th Annual Meeting of the German Society of experimental and clinical Pharmacology and Toxicology, Mainz, Germany, March 18 – 20 1999

11. The role of Interleukin-6 in stress-induced hyperthermia and emotional behaviour in mice BUTTERWECK, V., PRINZ, S., SCHWANINGER, M. Posterpresentation on the 41th Annual Meeting of the German Society of experimental and clinical Pharmacology and Toxicology, Mainz, Germany, March 21-23 2000

12. Selctive effects of long-term administration of St. John’s wort and hypericin ob gene transcription in brain areas involved in HPA axis control HERKENHAM, M., BRADY, LS., WINTERHOFF, H., BUTTERWECK, V. Posterpresentation on the 30th Annual Meeting of the Society of Neuroscience, New Orleans, USA, November 4 – 9 2000

13. Chronic administration of imipramine and St. John’s wort prevents the stress induced mRNA increase in brain areas involved in HPA axis control BUTTERWECK, V., WINTERHOFF, H., HERKENHAM, M. Posterpresentation on the 30th Annual Meeting of the Society of Neuroscience, New Orleans, USA, November 4 – 9 2000

14. MHC class I – a novel in vivo indicator of cellular stress

CV - page 13 FOSTER, J.A., BUTTERWECK, V., QUAN, N., STERN, E.L., HERKENHAM, M. Posterpresentation on the 30th Annual Meeting of the Society of Neuroscience, New Orleans, USA, November 4 – 9 2000

15. Long-term effects of St. John’s wort and hypericin on monoamine levels in rat hypothalamus and hippocampus BUTTERWECK, V., BÖCKERS, T., KORTE, B., WITTKOWSKI, W., WINTERHOFF, H. Posterpresentation on the 49th Annual Meeting of the Society for Medicinal Plant Research, Erlangen, Germany, September 2-6, 2001

16. In vitro receptor screening of pure constituents of St. John’s wort reveals novel interactions with a number of GPCRs BUTTERWECK, V., NAHRSTEDT, A., EVANS, J., HUFEISEN, B., ERNSBERGER, P., ROTH, B.L. Posterpresentation on the 31th Annual Meeting of the Society of Neuroscience, San Diego, USA, November 10 – 15 2001

17. Selective effects of long-term administration of St. John’s wort and isolated compounds on β-adrenergic binding in rat frontal cortex SIMBREY, K., WINTERHOFF, H., BUTTERWECK, V., WITTKOWSKI, W. Posterpresentation on the 31th Annual Meeting of the Society of Neuroscience, San Diego, USA, November 10 – 15 2001

18. Plasma levels of hypericin in presence of procyanidin B2: a pharmacokinetic study in rats BUTTERWECK, V., LIEFLÄNDER-WULF, U., WINTERHOFF, H., NAHRSEDT, A. Posterpresentation on the 50th Annual Meeting of the Society for Medicinal Plant Research, Barcelona, Spain, September 8-12, 2002

19. Neurotransmitter concentrations in different brain regions of rats following repeated treatment of a Cimicifuga racemosa extract BUTTERWECK, V., LÖHNING, A., SPENGLER, B., CHRISTOFFEL, V., WINTERHOFF, H. Posterpräsentation auf der Jahrestagung der Deutschen Pharmazeutischen Gesellschaft (DPhG), Berlin, 9.-12. Oktober, 2002

20. Extracts from Cimicifuga racemosa reduce the incidence of hot flush equivalents in a rat model WINTERHOFF, H., BUTTERWECK, V., LÖHNING, A., SPENGLER, B., CHRISTOFFEL, V. Posterpräsentation auf der Jahrestagung der Deutschen Pharmazeutischen Gesellschaft (DPhG), Berlin, 9.-12. Oktober, 2002

21. Activity of a hydroethanolic Hypericum-extract in behavioural, biochemical and pharmacokinetic models in rats WINTERHOFF, H., BUTTERWECK, V., SIMBREY, K., KELBER, O., OKPANYI, S.N. Posterpräsentation auf der Jahrestagung der Gesellschaft für Phytotherapie (GPht), Berlin, 10.-12. Oktober 2002

22. Flavonoids of St. John’s wort affect circulating levels of ACTH and corticosterone in rats BUTTERWECK, V., HEGGER, M., WINTERHOFF, H.

CV - page 14 Posterpräsentation auf der Jahrestagung der American Society of Pharmacognosy, International Congress on Natural Products Research, Phoenix, Arizona, USA, 31.Juli – 4. August, 2004

23. An extract of Gundelia tournefortii L. shows hypouricemic activity in vitro and in vivo assays SARAWEK, S., QADAN, F., DERENDORF, H., BUTTERWECK, V. Posterpräsentation auf der Jahrestagung der American Association of Pharmaceutical Sciences, Baltimore, USA, 7 – 11. November, 2004

24. Antioxidant and anxiolytic activity of Apocynum venetum L. GRUNDMANN, O., MERTENS-TALCOTT, S., BUTTERWECK, V. Posterpresentation on the 53rd Annual Meeting of the Society of Medicinal Plant Research, Florence, Italy August 21st – 26th, 2005

25. Variation of flavonoids and furanocoumarins in grapefruit juice: A source of variability in grapefruit drug- interaction studies DE CASTRO, W.V., MERTENS-TALCOTT, S., RUBNER, A., BUTTERWECK, V., DERENDORF, H. Posterpresentation on the 53rd Annual Meeting of the Society of Medicinal Plant Research, Florence, Italy August 21st – 26th, 2005

26. An extract and phenolic compounds from Apocynum venetum L. exert antidepressant activity in the tail suspension test in mice KIPKE, S., GRUNDMANN, O., PETEREIT, F., BUTTERWECK, V., NAHRSTEDT, A. Posterpresentation on the 53rd Annual Meeting of the Society of Medicinal Plant Research, Florence, Italy August 21st – 26th, 2005

27. Evaluation of Grapefruit juice and its compounds on P-gp activity DE CASTRO, W.V., MERTENS-TALCOTT, S., DERENDORF, H., BUTTERWERCK, V. Posterpresentation on the 47th Annual Meeting of the Society American Society of Pharmacognosy, Arlington, VA, August 5th – 9th 2006

CV - page 15 CURRICULUM VITAE - Amber L. Beitelshees

Date October 18, 2007

Personal Information: Sex Female Date of Birth 02-29-1976 Place of Birth Sarasota, FL

Citizenship USA

Address and Telephone

Office University of Florida Department of Pharmacy Practice PO Box 100486 Gainesville, FL 32610-0486 (352) 273-6262

Home: 1646 SW 16th St. Gainesville, FL 32608 (352) 373-2771

Present Position Assistant Professor

Education

Undergraduate

1994-1997 University of Florida, Gainesville, FL

Graduate

2001 Doctor of Pharmacy, University of Florida, Gainesville, FL

Postgraduate

2005 Master of Public Health (Epidemiology track), Summa Cum Laude. University of Florida College of Public Health and Health Professions, Gainesville, FL. Funded by the NIH Clinical Research Curriculum Award (K30) Graduated April 28, 2005.

Academic Positions/Employment

2007 – Present Assistant Professor, University of Florida, College of Pharmacy, Department of Pharmacy Practice, Gainesville, FL

2005- 2007 Research Assistant Professor of Medicine, Washington University, Cardiovascular Division, St. Louis, MO

Amber L. Beitelshees Page 2 of 10 2002-2005 University of Florida College of Pharmacy Cardiovascular Pharmacogenomics Fellow, Department of Pharmacy Practice. Mentor: Julie A. Johnson, Pharm.D.

2003 – 2005 Advanced Postgraduate Program in Clinical Investigation Fellow University of Florida, College of Medicine; Funded through NIH K30 award; Marian Limacher, M.D., Program Director, Gainesville, FL.

2001-2002 ASHP-Accredited Pharmacy Practice Residency University of Illinois Medical Center at Chicago; Frank Paloucek, PharmD, ABAT, Director, Chicago, IL

2001 – 2002 Clinical Associate, University of Illinois at Chicago, Chicago, IL

University and Hospital Appointments and Committees

2007 Genomic Medicine Curriculum Working Group, Washington University, St. Louis, MO

Medical Licensure and Board Certification

Licensed Pharmacist, Illinois. License number: 51288396; September 2001- present Licensed Pharmacist, Florida. License number: PS35818; July 2001- present

Honors and Awards

2005 Kenneth F. Finger Award, Research Fellow of the Year, University of Florida 2004 Runner-up, Best Student, Resident, Fellow Paper Award , American College of Clinical Pharmacy 2004 Annual Meeting 2003 Finalist, Best Student, Resident, Fellow Paper Award, American College of Clinical Pharmacy 2003 Annual Meeting 2003 Best Poster, Post-Doctoral Fellow Division, 16th Annual Research Showcase and Awards Day 2002 Richard Hutchinson Award, Resident of the Year, University of Illinois at Chicago

Editorial Responsibilities

2007 Grant Reviewer: American Heart Association, National Center 2006 Abstract reviewer, American Society of Clinical Pharmacology and Therapeutics Annual Meeting 2007 – present Manuscript reviewer, American Journal of Cardiology 2006 – present Manuscript reviewer, Expert Opinion on Pharmacotherapy 2006 – present Manuscript reviewer, Current Opinion in Molecular Therapeutics 2005 – present Manuscript reviewer, American Journal of Health System Pharmacy 2001 – present Manuscript reviewer; Annals of Pharmacotherapy. 2003 Pharmacology reviewer; ACC/ESC Clinical Expert Consensus Document on Hypertrophic Cardiomyopathy

Amber L. Beitelshees Page 3 of 10 Professional Societies and Organizations

2001 – present Member, American College of Clinical Pharmacy

2002 – present Member. American Society of Clinical Pharmacology and Therapeutics

2002 – present Member, American Heart Association Council on Epidemiology and Prevention

2000-2002 Member, American Society of Health-System Pharmacists

1997-2001 ASP-APhA

Research Support (role, title, duration, amount)

Active American Heart Association, Heartland Affiliate (Beitelshees) $145,000 07/01/2006-06/30/2008 Beginning Grant-in-Aid “Pathway pharmacogenetics and angiotensin receptor blocker responses”

The aim of this study is to determine in patients with cardiovascular disease and features of the metabolic syndrome whether the effects of telmisartan on glucose and lipid metabolism, adipocytokines, and ventricular remodeling differ by ADIPOQ genotype. Role: PI

P50 HL077113 (Kelly) 2/22/2005-12/31/2009 $742,225 NIH/NHLBI SCCOR in Cardiac Dysfunction and Disease Project 5 - Pharmacogenetics of Post-ACS Therapy (Province)

The major aim is to provide a quantitative assessment of the predictive impact of relevant genetic variants in the context of modern treatment for acute coronary syndrome. Role: Co-Investigator

Completed P50 HL077113 (Kelly) 2/22/2005-12/31/2009 NIH/NHLBI $804,620 SCCOR in Cardiac Dysfunction and Disease Core B- Applied Genomics Core (Beitelshees)

The applied genomics core provides sample processing and analytical support to the SCCOR Projects such as DNA extraction, analysis of single nucleotide polymorphisms, and gene informatics expertise to mine and annotate genetic variants in candidate genes. Role: PI

American College of Clinical Pharmacy (Beitelshees) $28,269 07/01/2006-06/30/2007 Frontiers Career Development Research Award “Uncoupling protein polymorphisms and acute coronary syndrome outcomes”

The aim of this study is to provide a replication dataset for evaluating the influence of UCP2 polymorphisms on outcomes and response to medications after an acute coronary syndrome. Amber L. Beitelshees Page 4 of 10 Role: PI

K24 HL68834-01 (Johnson) 1/1/02-12/31/06 NIH/NHLBI “ -receptor polymorphisms and cardiovascular pharmacogenomics”

The purpose of this Research Career Award is to provide additional protected research time to insure the continued success of the PI (mentor) in patient-oriented research and to aid in her training of future patient-oriented researchers. This award provides support to reduce teaching and administrative responsibilities of the PI to insure the ability to carry out patient-oriented research, including the project described in the current application. Role: Post-doctoral fellow

R01 HL64691 (Johnson) 4/1/00-3/31/04 NIH/NHLBI “ -adrenoceptor polymorphisms and hypertension”

The aims of this study are to determine if the 1 and/or 2 adrenergic receptor genes are: 1) hyptertension genes and/or contribute to racial differences in hypertension, 2) disease modifying genes specifically looking at the dipper phenotype in hypertension, or 3) drug modifying genes by looking at antihypertensive response to -blocker therapy. Role: Co-Investigator

Source: Abbott Laboratories (Johnson) 7/1/2002-6/30/04 “Heart disease outcomes: impact of genetics and pharmacogenetics”

The aims of this study are to investigate genetic biomarkers in a substudy of patients enrolled in the INVEST trial. INVEST is a 22,559 patient study of calcium channel blockers, -blockers, ACE inhibitors, and diuretics and their effects on outcomes in hypertension. Specifically, we will test hypotheses related to the pharmacogenetics of drug response and their effect on outcomes. Role: Co-Investigator

Pending

K23HL091120 (Beitelshees) 12/1/2007-11/30/2012 NIH/NHLBI “Uncoupling Protein Polymorphisms and Cardiometabolic Responses to -blockers”

This proposal serves to promote the career development of the PI in a mentored, structured program. This award will allow development of expertise in the area of cardiovascular pharmacogenomics and functional genomics by characterizing the variability in cardiometabolic responses to beta-blockers among individuals with diabetes. Role: PI; Mentor: Samuel Klein, M.D.

Clinical Title and Responsibilities

2003 – present Hospital Pharmacist, Malcolm Randall VA Medical Center, Gainesville, FL. 2001-2002 Clinical Pharmacist On-Call, University of Illinois at Chicago Amber L. Beitelshees Page 5 of 10 1998-2001 Pharmacy Intern, Walgreen’s Pharmacy, St. Petersburg, Florida and Gainesville, Florida. 1999 Pharmacy Intern, North Florida Reception Center, Gainesville, Florida. Teaching Title and Responsibilities

Pharmacotherapy II, University of Florida, 2nd year pharmacy students Chronic Heart Failure, 4 hours of lecture and 1 hour case, Fall 2007.

Principles of Pharmacology, Washington University, 2nd year medical students Pharmacogenomics I & II, 2 hour lecture, Fall 2006.

Introduction to Clinical Translational Research, Washington University, sub-specialty research fellows and junior faculty Integration of genomic information into therapy selection, 1.5 hour lecture, Spring 2006.

Computational Statistics Genetics, M21-621, Washington University, Genetic Epidemiology Masters Students Pharmacodynamic pharmacogenetics 1.5 hour lecture, Fall 2005 and Spring 2007 Leveraging informatic tools to conduct pharmacogenetics research, 1.5 hour lecture, Fall 2005 and Spring 2007. Introduction to Pharmacogenomics, 1.5 hour lecture, Spring 2007.

Pharmacological Basis of Therapeutics I, PHA 5516, University of Florida, 2nd year pharmacy students Calcium channel blockers, 1.5 hour lecture, Fall 2003-2004. Antihyperlipidemics, 1.5 hour lecture, Fall 2002-2004. Anticoagulants, 1.5 hour lecture, Fall 2002.

Pharmacotherapy II, PHA 5782, University of Florida, 2nd year pharmacy students Arrhythmias, 4 hour lecture, Fall 2004. Chronic stable angina, 2 hour lecture, Fall 2003.

Pharmacotherapy I, PHA 5781, University of Florida, 1st year pharmacy students Introduction to cardiovascular disease, 2 hour lecture, Spring 2003-2005.

Practicum I, PHA 5941, University of Florida, 3 hours of supervision to 1st year pharmacy students in community outreach sites. Fall 2002-2003.

Bibliography

Beitelshees AL, Gong Y, Schork NJ, Cooper-DeHoff RM, Langaee TY, Shriver MD, Pepine CJ, Johnson JA. KCNMB1 genotype influences response to verapamil SR and adverse outcomes in the INternational VErapamil SR/Trandolapril STudy (INVEST). Pharmacogenet Genom 2007;17(9):719-29.

Gong Y, Beitelshees AL, Wessel J, Langaee TY, Schork NJ, Johnson JA. SNP discovery and haplotype analysis of BK channel -1 subunit. Pharmacoget Genom 2007;17(4):267-75.

Aquilante CL, Beitelshees AL, Zineh I. Predictors of serum matrix metalloproteinase-8 (MMP-8) concentrations in nondiabetic subjects without cardiovascular disease. Clin Chim Acta 2007;379:48-52

Amber L. Beitelshees Page 6 of 10 Zineh I, Beitelshees AL, Haller MJ. NOS3 Polymorphisms are Associated with Arterial Stiffness in Children with Type 1 Diabetes. Diabetes Care 2007;30: 689-693.

Lobmeyer MT, Gong Y, Terra SG, Beitelshees AL, Langaee TY, Pauly DF, Scofield RS, Hamilton KK, Patterson JH, Adams KF, Hill JA, Aranda JM, Johnson JA. Synergistic polymorphisms of the 1- and 2c-adrenergic receptors and the influence on left ventricular ejection fraction response to -blocker therapy in heart failure. Pharmacoget Genom 2006; 17(4):277-82.

Beitelshees AL, Zineh I, Yarandi HN, Pauly DF, Johnson JA. Influence of phenotype and pharmacokinetics on -blocker drug target pharmacogenetics. Pharmacogenomics J 2006;6(3):174-8.

Beitelshees AL, Zineh I, Yarandi HN, Pauly DF, Johnson JA. Discordant -blocker effects on clinic, ambulatory, resting, and exercise hemodynamics in patients with hypertension. Pharmacotherapy 2006;26(9):1247-54.

Zineh I, Aquilante CL, Langaee TY, Beitelshees AL, Arrant CB, Wessel TR, Schofield RS. CXCL5 gene polymorphisms are related to systemic concentrations and leukocyte production of epithelial neutrophil-activating peptide (ENA-78). Cytokine 2006;33(5):258-63.

Zineh I, Pebanco GD, Aquilante CL, Gerhard T, Beitelshees AL, Beasley BN, Hartzema AG. Discordance between availability of pharmacogenetic studies and pharmacogenetics-based prescribing information for the top 200 drugs. Ann of Pharmacother 2006; 40(4):639-44.

Zineh I, Gerhard T, Aquilante CL, Beitelshees AL, Beasley BN, Hartzema AG. Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs. Pharmacogenomics J 2004;4:354-8.

Zineh I, Beitelshees AL, Gaedigk A, Walker JR, Pauly DF, Eberst K, Leeder JS, Phillips MS, Gelfand CA, Johnson JA. Pharmacokinetics and CYP2D6 genotypes do not predict metoprolol adverse events or efficacy in hypertension. Clin Pharmacol Ther 2004;76(6):536-44.

Cavallari LH, Fashingbauer, LA, Beitelshees AL, Groo VL, Southworth MR, Viana MAG, Williams RE, Dunlap SH. Racial differences in patients' potassium concentrations during spironolactone therapy for heart failure. Pharmacotherapy 2004;24(6):750-756.

Abstracts: Beitelshees AL, Zineh I, Cresci S, Wu J, Minton MR, Province MA, Spertus JA. CXCL5 genotype is associated with mortality after acute coronary syndromes. Circulation 2007 [in press]. To be presented as an oral presentation at the 2007 Scientific Sessions, Orlando, FL.

Baker J, Xiao L, Lanfear DE, Cresci S, Jones PG, Wu J, Province MA, Spertus JA, Beitelshees AL. Interaction between ADRA2C genotype and beta-blocker response in acute coronary syndromes [363]. Pharmacotherapy 2007;348. Presented at the American College of Clinical Pharmacy 2007 Annual Meeting in Denver, CO October 14-17.

Beitelshees AL, Xiao L, Cresci S, Jones PG, Wu J, Minton MR, Province MA, Kelly DP, McLeod HL, Spertus JA. UCP2 -866 G/A polymorphism influences beta-blocker response in post-acute coronary syndrome diabetic individuals [373]. Pharmacotherapy 2007;348. Presented at the American College of Clinical Pharmacy 2007 Annual Meeting, October 14-17, 2007, Denver, CO.

Amber L. Beitelshees Page 7 of 10 Zineh I, Welder GJ, Beitelshees AL, Chegini N, Wu J, Cresci S, Province MA, Spertus JA. CXCL5 is an endothelial target and pharmacogenetic candidate for statins [289]. J Clin Lipidol 2007;1(5):449. Presented at the Drugs Affecting Lipid Metabolism (DALM) Meeting, October 4- 7, 2007, New York, NY.

Ma CX, Cresci S, Wu J, Minton M, Jones PG, Province MA, McLeod HL, Spertus JA, Beitelshees AL. Aromatase Genotype Predicts Survival After Acute Coronary Syndrome. Clin Pharmacol Ther 2007;81(Suppl 1):S11. Oral presentation at the American Society of Clinical Pharmacology and Therapeutics (ASCPT) 2007 Annual Meeting, March 21-24, 2007, Anaheim, CA.

Zineh I, Beitelshees AL, Haller MJ. Association between NOS3 polymorphisms and arterial stiffness in children with type 1 diabetes. Clin Pharmacol Ther 2007;81(Suppl 1):S15. Poster presentation at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, March 21-24, 2007, Anaheim, CA.

Price ET, Beitelshees AL, Zineh I. Liver-X receptor- (LXRA) haplotype and C-reactive protein response to atorvastatin. Clin Pharmacol Ther 2007;81(Suppl 1):S34. Poster presentation at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, March 21-24, 2007, Anaheim, CA.

Welder GJ, Beitelshees AL, Aquilante CL, Allayee H, Langaee TY, Schofield RS, Zineh I. Influence of CXCL5 polymorphisms on blood pressure in adults without cardiovascular disease. Poster presentation at the Cold Spring Harbor Laboratory Pharmacogenomics Meeting, Cold Spring Harbor, NY. November 2006.

Beitelshees AL, Cresci S, Jones P, Minton MR, Kelly DP, Spertus J, McLeod HL. UCP2 genotype influences response to post-acute coronary syndrome therapy. Circulation 2006:114(18):II-788. Presented as an oral presentation at the American Heart Association Scientific Sessions 2006, Chicago, IL. November 2006.

Lanfear D, Jones PG, Marsh S, Beitelshees AL, Cresci S, McLeod HL, Spertus JA. Genetic Polymorphisms in the ACE Gene and the GJA4 Gene Modify ACE-inhibitor Efficacy in Post- ACS Patients. Circulation 2006. Presented as an oral presentation at the American Heart Association Scientific Sessions 2006, Chicago, IL. November 2006.

Cresci S, Huss JM, Beitelshees AL, Jones PG, Minton MR, Spertus JA, McLeod HL. Mortality in Diabetic Acute Coronary Syndrome Patients is Associated with a Novel Variant in the PPAR alpha Gene Promoter that Confers Differential ERR Binding. Circulation 2006. Presented as an oral presentation at the American Heart Association Scientific Sessions 2006, Chicago, IL. November 2006.

Beitelshees AL, Gong Y, Cooper-DeHoff RM, Burt L, Stauffer L, Pepine CJ, Johnson JA. KCNMB1 genotype associated with cardiovascular outcomes in the INternational VErapamil SR/trandolapril STudy (INVEST). Clin Pharmacol Ther 2006;79(2):P41. Presented as poster presentation at the American Society for Clinical Pharmacology and Therapeutics 107th Annual Meeting. Baltimore, MD. March 2006.

Gong Y, Beitelshees AL, Stauffer LA, Langaee TY, Cooper-DeHoff RM, Pepine CJ, Johnson JA, 2006. Beta adrenergic receptors polymorphisms are associated with response to beta-blocker therapy in the INternal VErapamil SR-Trandolapril Sudy (INVEST). Clin Pharmacol Ther 2006;79(2):P30. Presented as podium presentation at the 107th Annual meeting of the American Society for Clinical Pharmacology and Therapeutics in Baltimore, MD, March 2006.

Amber L. Beitelshees Page 8 of 10 Aquilante CL, Beitelshees AL, Rome LC, Kosmiski L. Influence of resistin promoter polymorphisms on plasma resistin levels in nondiabetic subjects. Pharmacotherapy 2006; 26: number 87. Presented as poster at the American College of Clinical Pharmacy 2006 Spring Practice and Research Forum. Monterey, CA. April 2006.

Gerhard T, Gong Y, Beitelshees AL, Lobmeyer M, Schiefelbein L, Langaee TY, Cooper-DeHoff RM, Johnson JA. Association between CV outcomes, diuretic use and the alpha-adducin gene; Results from the INternational VErapamil SR-Trandolapril STudy (INVEST). Circulation 2005; 112 (17): U670-U670 Suppl. S.

Beitelshees AL, Gong Y, Moss J, Cooper-Dehoff RM, Pepine CJ, Johnson JA. Variable blood pressure response to verapamil by KCNMB1 genotype. Clin Pharmacol Ther 2005;77(2):P97. Presented as oral presentation at the American Society for Clinical Pharmacology and Therapeutics 106th Annual Meeting, Orlando, FL, March 2005.

Gong Y, Beitelshees AL, Stauffer L, Gaston K, Sloan A, Yarandi HN, Langaee TY, Cooper- Dehoff RM, Pepine CJ. 2-adrenergic receptor (B2AR) polymorphisms and antihypertensive response to -blocker therapy in the INVEST trial. Clin Pharmacol Ther 2005;77(2):P97. Presented as a poster presentation at the American Society for Clinical Pharmacology and Therapeutics 106th Annual Meeting, Orlando, FL, March 2005.

Beitelshees AL, Langaee TY, Johnson JA. SNP discovery using denaturing HPLC for the CACNA1C gene. Pharmacotherapy 2004;124(10):1458. Runner-up, Best Student, Resident, Fellow Paper Award Competition. Presented as platform presentation at the ACCP 2004 Annual Meeting, Dallas, TX, October 2004.

Zineh I, Gerhard T, Aquilante CL, Beitelshees AL, Beasley BN, Hartzema AG. Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs. Pharmacogenomics J 2004;4:354-8. Presented at the 20th International Conference on Pharmacoepidemiology and Therapeutic Risk Management of the International Society for Pharmacoepidemiology, Bordeaux, France, August 2004.

Beitelshees AL, Zineh I, Gaedigk A, Leeder JS, Walker JR, Eberst K, Timmerbeil BS, Lobmeyer M, Pauly DF, Johnson JA. Effect of CYP2D6 phenotype and metoprolol pharmacokinetics on adverse effects. Clin Pharmacol Ther 2004;75(2):P95. Presented as moderated poster presentation at the 105th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Miami, FL, April 2004.

Beitelshees AL, Cavallari LH, Gaston KG, Okorochukwu TU, Johnson JA. Beta1-adrenergic receptor polymorphisms and hypertension. Clin Pharmacol Ther 2004;75(2):P61. Presented as poster presentation at the 105th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Miami, FL, April 2004.

Beitelshees AL, Zineh I, Yarandi HN, Puckett BJ, Langaee TY, Pauly DF, Johnson JA. Utility of clinic versus ambulatory blood pressure for pharmacogenetic studies. Pharmacotherapy 2003;23(10):1357. Finalist Best Student, Resident, Fellow Paper Award. Presented as poster at the American College of Clinical Pharmacy 2003 Annual Meeting, Atlanta, GA, November 2003. Beitelshees AL, Zineh I, Yarandi HN, Puckett BJ, Pauly DF, Johnson JA. Contribution of Gs and 2-adrenergic receptor polymorphisms to antihypertensive response to -blockers. Clin Pharmacol Ther 2003;73(2):P98. Abstract. Presented as a moderated poster at the 104th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Washington, D.C., April 2003.

Amber L. Beitelshees Page 9 of 10 Beitelshees AL, Bauman JL, Southworth MR, DiDomenico RJ, Dunlap SH, Fashingbauer LA, Humma LM. Cost-savings associated with a decreased need for potassium supplementation in heart failure patients started on spironolactone. Pharmacotherapy 2002;22:1327. Presented as platform presentation at American College of Clinical Pharmacy 2002 Annual Meeting. Albuquerque, NM. October 21, 2002.

Humma LM, Fashingbauer LA, Beitelshees AL, Just VL, Southworth MR, Williams RE, Dunlap S. Effects of race and gender on potassium requirements with spironolactone therapy in heart failure. J Cardiac Failure 2002;8(4):S60 (P218).

Invited publications (e.g. reviews, book chapters, letters, etc)

Beitelshees AL, Zineh I. Renin-angiotensin-aldosterone system (RAAS) pharmacogenomics: implications in heart failure management. Heart Failure Reviews. In press.

Zineh I, Beitelshees AL, van Schaik RHN. Comment on the SACGHS`s report "Realizing the Promise of Pharmacogenomics: Opportunities and Challenges"

Aquilante CL, Zineh I, Beitelshees AL, Langaee TY. Common laboratory methods in pharmacogenomic studies. Am J Health Syst Pharm 2006;63(21):2101-10.

Beitelshees AL, McLeod HL. Applying pharmacogenomics to enhance the use of biomarkers for drug effect and drug safety. Trends Pharmacol Sci 2006;27(9):498-502.

Beitelshees AL, McLeod HL. Clopidogrel Pharmacogenetics: Promising steps towards patient care? Arterioscl Throm Vasc 2006;26:1681-1683.

Gerhard T, Beitelshees AL, Johnson JA. Re: Meckley LM, Veenstra DL. Screening for the alpha- adducin Gly460Trp variant in hypertensive patients: a cost-effectiveness analysis. Pharmacogenet Genom 2006; 16:139-147. [letter] Pharmacogenet Genomics 2006 Aug;16(8):613.

Beitelshees AL. ACC/AHA guidelines for treatment of STEMI updated. Today in Cardiology 2004;7(10):8-10.

Johnson JA, Zineh I, Langaee TY, Beitelshees AL. “Caution with 1-adrenergic receptor genotyping - Reply". [letter] Clin Pharmacol Ther 2004;76:186.

Beitelshees AL, Humma LM, DiDomenico RJ. What’s best in the cath lab? Today in Cardiology 2003;6(1):18.

Invited presentations

Integration of genomics into therapy selection. ACPE approved seminar, American Society of Health-System Pharmacists Midyear Meeting, Anaheim, CA. December 6, 2006.

The influence of pharmacogenomics on health disparity and pain management. ACPE approved seminar, Pain and Palliative Care PRN Focus Session, 2006 ACCP Annual Meeting, St. Louis, MO. October 26, 2006.

Optimizing cardiovascular therapeutics: from genotype to phenotype and back. CME approved seminar. Washington University Center for Cardiovascular Research Seminar Series. April 11, 2006.

Amber L. Beitelshees Page 10 of 10 Heart failure therapeutics in the genomic era. CME approved seminar, Missouri Baptist Medical Center Grand Rounds. February 8, 2006.

Heart failure therapeutics in the genomic era. CME approved seminar, Plenary Address, Congestive Heart Failure Update, Washington University School of Medicine. December 3, 2005.

Antihypertensive pharmacogenomics: a focus on genotype-phenotype relationships. ACPE approved seminar, University of Florida Center for Pharmacogenomics seminar series, February 2005.

Verapamil Pharmacogenetics. ACPE approved seminar, University of Florida Center for Pharmacogenomics seminar series, April 2004.

Utility of Clinic Versus Ambulatory Blood Pressure for Pharmacogenetic Studies. ACPE approved seminar, University of Florida College of Pharmacy, Ken Finger Memorial Golf Classic October 2003.

Principal Investigator/Program Director (Last, First, Middle): Zineh, Issam

BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES.

NAME POSITION TITLE Issam Zineh, Pharm.D. Assistant Professor eRA COMMONS USER NAME izineh EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) DEGREE INSTITUTION AND LOCATION YEAR(s) FIELD OF STUDY (if applicable) Northeastern University (Boston) Pharm.D. 09/94-06/00 Pharmacy Duke University Medical Center (Durham) Residency 07/00-06/01 Clinical pharmacy University of Florida (Gainesville) Fellowship 07/01-12/03 Cardiovascular Pharmacogenomics

A. Positions and Honors

Professional Experience 2000-2001 Duke University Medical Center, Surgery Pharmacist 2002-present Malcolm Randall (N. Florida/S. Georgia) VA Medical Center, Staff Pharmacist 2004-present Assistant Professor (Pharmacy Practice), University of Florida 2005-present Assistant Professor (Pharmaceutics), University of Florida 2005-present Fellow, Advanced Program in Post-Graduate Investigation (NIH K30 RR022258-07), University of Florida

Professional Awards and Honors Rho Chi Honor Society Sophomore Honors Award (1996); Golden Key National Honor Society (1996); Rho Chi Honor Society, Beta Tau Chapter, Boston, MA (1998); Excellence in Non-prescription Medications Teaching Award (1999); American Institute of the History of Pharmacy Certificate of Recognition (1999); Summa Cum Laude, Northeastern University (2000); Harold D. Hodgkinson Achievement Award (2000); Sears B. Condit Award (2000); Pfizer U.S. Pharmaceutical Outstanding Leader Award (2000); Eli Lilly & Co. Ethics, Scholarship, and Leadership Award (2000); Massachusetts Society of Health-System Pharmacists Excellence Award (2000); Outstanding Postdoctoral Fellow of 2002, American Heart Association (AHA) Florida/Puerto Rico Affiliate (2002); Best Overall Paper, American College of Clinical Pharmacy (ACCP) (2002); Best Postdoctoral Paper, 15th Annual Research Showcase and Awards Day, University of Florida (2002); Best Postdoctoral Paper, 16th Annual Research Showcase and Awards Day, University of Florida (2003); American Society for Clinical Pharmacology and Therapeutics (ASCPT) Presidential Trainee Award (2003); Best Overall Paper, ACCP Spring Practice and Research Forum (2006); ASCPT Presidential Trainee Award (awarded to my trainee GJ Welder) (2007)

National and International Invited Lectures 2003 Pharmacogenomics and the Risk Management Paradigm; International Society for Pharmacoepidemiology (ISPE) (Philadelphia, PA) 2004 Influence of Pharmacogenomics on Clinical Trial Design; ACCP (Dallas, TX) 2006 From Bench to Bedside and Back: The Role of the Pharmacist in Translational Research; International Symposium on Clinical Pharmacy; Fudan University (Shanghai, China) Pharmacogenomics of Metabolic Syndrome: Hope or Hype?; ACCP (St. Louis, MO)

Professional Appointments and Activities 2005-present NIH Pharmacogenetics Research Network (PGRN) Task Force on FDA Relations, member NIH Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) Steering Committee, member 2006-present AHA Behavioral Science, Epidemiology, & Prevention 1 and 2 study sections (BSEP) AHA International Mentoring Program, mentor Vice Chair, Pharmacogenetics and Molecular Pharmacology Section, Coordinating Committee on Scientific Sections, ASCPT NIH PGRN White Papers Task Force, Heart Lung Action Group, and Adverse Drug Reactions Working Group Editorial Board, Journal of Clinical Lipidology 2007-present University of Florida Genetics Institute Executive Committee

PHS 398/2590 (Rev. 09/04) Page Biographical Sketch Format Page Principal Investigator/Program Director (Last, First, Middle): Zineh, Issam

Ad hoc reviewer: European Journal of Clinical Pharmacology; American Journal of Health-System Pharmacy; Journal of Cardiovascular Nursing (2006-present); Expert Opinion on Drug Metabolism and Toxicology; Clinical Cardiology; Clinical Pharmacology and Therapeutics; Future Cardiology; American Journal of Cardiology (2005-present); Human Genomics; Journal of Clinical Pharmacology; British Journal of Clinical Pharmacology (2004-present); Pharmacotherapy (2001- present); Annals of Pharmacotherapy; Journal of the American Pharmaceutical Association (2000-2004)

Professional Memberships and Affiliations American Society of Health-System Pharmacists (1999-2002); ACCP (2000-present); ACCP Cardiology Practice and Research Network; University of Florida Center for Pharmacogenomics (2001-present); American Society for Clinical Pharmacology and Therapeutics (2002-present); ISPE; International Atherosclerotic Society; AHA Council on Arteriosclerosis, Thrombosis, and Vascular Biology and Functional Genomics and Translational Biology Interdisciplinary Working Group (2004-present); National Lipid Association (2005-present)

B. Selected peer-reviewed publications and book chapters (in chronological order)

1. Johnson JA, Zineh I, Puckett BJ, McGorray SP, Yarandi HN, and Pauly DF. β1-adrenergic receptor polymorphisms and antihypertensive response to metoprolol. Clin Pharmacol Ther 2003;74(1):44-52. 2. Zineh I, Schofield RS, and Johnson JA. The evolving role of nesiritide in advanced or decompensated heart failure. Pharmacotherapy 2003;23(10):1266-80. 3. Langaee TY, Zineh I. Applied Molecular and Cellular Biology. In: Allen WL, Johnson JA, Knoell DL, et al. (eds). Pharmacogenomics: Applications to Patient Care; Modules 1-3. Kansas City: American College of Clinical Pharmacy, 2004:53-116.

4. Johnson JA, Langaee TY, Zineh I, Beitelshees AL. Caution with β1-adrenergic receptor genotyping [reply]. Clin Pharmacol Ther 2004;76(2):186. 5. Zineh I. Genetic polymorphisms and statin therapy [letter]. JAMA 2004;292(11):1302-3. 6. Zineh I, Gerhard T, Aquilante CL, Beitelshees AL, Beasely BN, Hartzema AG. Availability of pharmacogenomics- based prescribing information in drug package inserts for currently approved drugs. Pharmacogenomics J 2004;4(6):354-8. 7. Zineh I, Beitelshees AL, Gaedigk A, Walker JR, Pauly DF, Eberst K, Leeder JS, Phillips MS, Gelfand CA, Johnson JA. Pharmacokinetics and CYP2D6 genotypes do not predict metoprolol adverse events or efficacy in hypertension. Clin Pharmacol Ther 2004;76:536-44. 8. Zineh I. HMG-CoA reductase inhibitor pharmacogenomics: overview and implications for practice [invited review]. Future Cardiol 2005;1(2):191-206. 9. Zineh I, Cooper-DeHoff RM, Wessel TR, Arant CB, Slight P, Geiser EA, Pepine CJ. Global differences in blood pressure control and clinical outcomes in the INternational VErapamil-SR Trandolapril STudy (INVEST). Clin Cardiol 2005;28:321-8. 10. Gerhard T, Zineh I, Winterstein AG, Hartzema AG. Pharmacoeconomic modeling of nesiritide versus dobutmaine for decompensated heart failure. Pharmacotherapy 2006;26(1):34-43. 11. Beitelshees AL, Zineh I, Yarandi HN, Pauly DF, Johnson JA. Influence of phenotype and pharmacokinetics on β- blocker drug target pharmacogenetics. Pharmacogenomics J 2006;6:174-8. 12. Zineh I, Luo X, Welder GJ, DeBella AE, Wessel TR, Arant CB, Schofield RS, Chegini N. Modulatory effects of atorvastatin on endothelial cell-derived chemokines, cytokines, and angiogenic factors. Pharmacotherapy 2006;26(3):333-340. 13. Zineh I, Pebanco GD, Aquilante CL, Gerhard T, Beitelshees AL, Beasley BN, Hartzema AG. Discordance between availability of pharmacogenetic studies and pharmacogenetics-based prescribing information for the top 200 drugs. Ann Pharmacotherapy 2006;40(4):639-44. 14. Zineh I, Aquilante CL, Langaee TY, Beitelshees AL, Arant CB, Wessel TR, Schofield RS. CXCL5 gene polymorphisms are related to systemic concentrations and leukocyte production of epithelial neutrophil-activating peptide (ENA-78). Cytokine 2006;33:258-63. 15. Zineh I, Welder GJ, Langaee TY. Development and cross-validation of sequencing-based assays for genotyping common polymorphisms of the CXCL5 gene. Clin Chim Acta 2006;370(1-2):72-5. 16. Aquilante CL, Langaee TY, Anderson PL, Zineh I, Fletcher CV. Multiplex PCR-pyrosequencing assay for genotyping CYP3A5 polymorphisms. Clin Chim Acta 2006;372(1-2):195-8. 17. Zineh I, Johnson JA. Pharmacogenetics of chronic cardiovascular drugs: applications and implications [invited review]. Expert Opin Pharmacother 2006;7(11):1417-27. 18. Li R, Luo X, Pan Q, Zineh I, Archer DF, Williams RS, Chegini N. Doxycycline alters expression of inflammatory and immune related cytokines and chemokines in human endometrial cells: implications in dysfunctional uterine bleeding. Hum Reprod 2006;21(10):2555-63. 19. Beitelshees AL, Zineh I, Yarandi HN, Pauly DF, Johnson JA. Discordant β-blocker effects on clinic, ambulatory, resting, and exercise hemodynamics in patients with hypertension. Pharmacotherapy 2006;26(9):1247-54.

PHS 398/2590 (Rev. 09/04) Page Biographical Sketch Format Page Principal Investigator/Program Director (Last, First, Middle): Zineh, Issam

20. Aquilante CL, Zineh I, Beitelshees AL, Langaee TY. Common laboratory methods in pharmacogenomics. Am J Health-Syst Pharm 2006;63:2101-10. 21. Zineh I, Welder GJ, DeBella AE, Arant CB, Wessel TR, Schofield RS. Atorvastatin effect on circulating and leukocyte-produced CD40 ligand concentrations in people with normal cholesterol: a pilot study. Pharmacotherapy 2006;26(11):1572-7. 22. Welder GJ, Wessel TR, Arant CB, Schofield RS, Zineh I. Complementary and alternative medicine (CAM) use among individuals participating in research: implications for research and practice. Pharmacotherapy 2006;26(12):1794-1801. 23. Shin J, Lobmeyer MT, Gong Y, Zineh I, Langaee TY, Yarandi H, Schofield RS, Aranda Jr. JM, Hill JA, Pauly DF, Johnson JA. Relation of A ß2-adrenoceptor haplotype to risk of death and heart transplantation in patients with heart failure. Am J Cardiol 2007;99:250-5. 24. Gaedigk A, Ndjountche L, Divakaran K, Bradford LD, Zineh I, Oberlander TF, Brousseau DC, McCarver GD, Johnson JA, Alander SW, Riggs KW, Leeder JS. Cytochrome P4502D6 (CYP2D6) gene locus heterogeneity: discovery of novel gene duplications in African Americans. Clin Pharmacol Ther 2007;86(2):242-51. 25. Zineh I, Beitelshees AL, Haller MJ. NOS3 polymorphisms are associated with arterial stiffness in children with type 1 diabetes. Diabetes Care 2007;30:689-93. 26. Johnson JA, Zineh I. Pharmacogenetics and Personalized Medicine. In: Zhao V (ed). Cardiovascular Genetics and Genomics for the Cardiologist [in press]. 27. Zineh I. Pharmacogenetics of response to statins [invited review]. Curr Atheroscler Rep 2007;9(5) [in press]. 28. Aquilante CL, Beitelshees AL, Zineh I. Correlates of serum matrix metalloproteinase-8 (MMP-8) concentrations in nondiabetic patients without cardiovascular disease. Clin Chim Acta 2006 [in press]. 29. Bleske BE, Hwang HS, Zineh I, Boluyt MO. Evaluation of immunomodulatory biomarkers in a pressure overload model of heart failure. Pharmacotherapy 2006 [accepted for publication]..

C. Research Support Active Research Support 0435278B July 2004 to June 2007 American Heart Association (FL/PR Affiliate) Role: PI Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis The aims of this study are to characterize the systemic immunomodulatory effects of atorvastatin in patients who are currently recommended for lifestyle modifications, but not drug treatment, based on dyslipidemia guidelines. Genetic variation as a contributor to variable statin immunomodulation is also explored.

U01 HL083459 (PI: Julie A. Johnson, Pharm.D.) September 2005 to August 2010 National Institutes of Health (NIH) Role: Co-investigator Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) This study investigates genetic determinants of antihypertensive and adverse drug responses to commonly used blood pressure medications through candidate gene and genome-wide approaches. Dr. Zineh serves on the steering committee and leads efforts in pharmacogenetics of adverse metabolic side effects.

Completed Research Support 1 R01 HL64691 (PI: Julie A. Johnson, Pharm.D.) April 2000 to December 2003 NIH/NHLBI Role: Postdoctoral Fellow, 07/01 to 12/03 β-Adrenoreceptor Polymorphisms and Hypertension The aims of this study are to determine if the β1- and/or β2-adrenergic receptor genes are: 1) hypertension genes and/or contribute to racial differences in hypertension, 2) disease modifying genes specifically looking at the dipper phenotype in hypertension, or 3) drug response modifying genes by looking at antihypertensive response to β-blocker therapy.

0225248B July 2002 to December 2003 American Heart Association (FL/PR Affiliate) Role: PI (Post-doctoral fellowship grant) Type-A Natriuretic Peptide Receptor Polymorphisms in Hypertension, Heart Failure Prognosis, and Response to Nesiritide The aims of this study are to identify common polymorphisms of the NPR-A receptor and determine whether these: 1) influence hypertension, 2) are associated with differences in prognosis among patients with heart failure, or 3) influence drug response by looking at clinical improvement with nesiritide in patients with heart failure.

T35 HL07489 National Institutes of Health (NIH) May 2004 to July 2004 UF Medical Sciences Research Program Role: Faculty sponsor

PHS 398/2590 (Rev. 09/04) Page Biographical Sketch Format Page Principal Investigator/Program Director (Last, First, Middle): Zineh, Issam

Association Between Renin-Angiotensin-Aldosterone System (RAAS) Gene Polymorphisms and Heart Failure Prognosis The aim of this study is to determine if polymorphisms in angiotensinogen, ACE, or angiotensin II type 1 receptor genes are associated with differences in prognosis among patients with heart failure being treated within contemporary management guidelines.

Kos Dyslipidemia Research Award July 2004 to June 2005 American College of Clinical Pharmacy Role: PI Atorvastatin Immunomodulation in Early Atherosclerosis The aims of this study are to determine atorvastatin immunomodulation in subjects with 0-1 risk factor according to ATP III guideline stratification, as this represents a pure population in which to study the pleotropic effects of statins as a drug class.

T35 HL07489 National Institutes of Health (NIH) May 2005 to August 2005 UF Medical Sciences Research Program Role: Faculty sponsor Effect of an HMG-CoA Reductase Inhibitor on Serum Leptin and IP-10 Concentrations in Early Atherosclerosis The aim of this study is to determine if part of the disease-modifying effects of statins is through systemically measurable changes in leptin and IP-10 concentrations in young adults without coronary disease or coronary disease risk equivalents.

American Heart Association (FL/PR Affiliate) May 2006 to August 2006 UF Medical Science Research Program Role: Faculty Sponsor Immunomodulation of human endothelial cells by Vaccinium berry extract and astaxanthin The aim of this study is to investigate the effects of wild Vaccinium berry and astaxanthin on chemokines, cytokines, and angiogenic factors produced from human umbilical vein endothelial cells (HUVECs).

PHS 398/2590 (Rev. 09/04) Page Biographical Sketch Format Page

TAIMOUR Y. LANGAEE

1505 Ft-Clarke Blvd. 8-201 (352)333-0260 Gainesville, Fl 32606 [email protected]

EXPERIENCE:

Research Assistant Professor; 2002-Present Director; UF Center for Pharmacogenomics (UFCPGx) Genotyping Core Laboratory, Dept. of Pharmacy Practice, College of Pharmacy, University of Florida

• Directing the UFCPGx core genotyping laboratory • Teaching Pharmacy professional and graduate students • Advising pharmacy students • Supervising and mentoring professional and graduate Pharmacy students and Postdoctoral fellows • Supervising and training of laboratory Technicians • Developing and establishing new assays • Planning and establishing high throughput systems for genotyping • Large scale genotyping, processing and genetic analysis of clinical samples • Collaborating on clinical research projects in College of Pharmacy and other Colleges at UF and Other universities

Postdoctoral Fellow; 2001-2002 University of Florida, Dept. of Molecular Genetics and Microbiology

• Plan, develop and execute projects • Develop DNA chips for Pseudomonas aeruginosa • Apply DNA chip technology to study gene duplication/deletion and expression Profiles of CF (Cystic Fibrosis) isolates of P. aeruginosa • Applying in vivo and in vitro conditions to study the expression profile of P. aeruginosa under CF lung environment • Large scale screening of potential antimicrobial targets

Postdoctoral Fellow; 1999-2001 University of McGill and Montreal, Dept. of Molecular Genetics and Immunology

• Involved in vaccine development project • Establish new techniques • Bioinformatics, search DNA and protein databases for sequence pattern, gene finding; prediction of protein sequence

• Provide training and supervision of graduate students and technicians • Attend scientific meetings, interact and collaborate with other scientists

Ph.D. Candidate; 1994–1999 Laval University, Dept. of Molecular Genetics and Microbiology

• Planing projects, designing appropriate experimental techniques, problem solving • Gene discovery, using the existing search engines in NCBI to discover new genes involved in resistance to beta-lactam antibiotics in Pseudomonas aeruginosa • Drug Resistance, elucidating the model for beta-lactam antibiotics resistance in Gram-negative bacteria and proposing new model for Pseudomonas aeruginosa, • Analyzing and discussing results, attending scientific meetings, giving seminars • Supervising technicians and students, teaching and assisting microbiology courses

Director of Quality Control Laboratory 1987–1994 Bayer Pharmaceutical Corporation

• Write and Implement USP Microbiological procedures • Review results and technical reports prior to release of product • Evaluation of raw material, intermediates, and finished products • Train personnel on cGMP, cGLP, SOP and other regulatory requirements. • Supervise technicians, evaluate employee performance, and ensure career development

SKILLS:

Molecular Biology: DNA and RNA extraction; PCR; RT-PCR; DNA Chip Technology (Microarray slide processing and post processing, Cy labeling of genomic DNAand RNA, Competitive hybridization, Microarray data analysis); Plasmid and Strain construction; Electrophoresis; DNA Cloning; Transformation; Hybridization; In Situ-Hybridization; Southern and Northern Blotting; Dot Blotting; Screening of DNA Libraries; Amplification of Bacteriophage Library; Expression of Cloned Genes in E. coli; Protein Expression, Protein Assay and analysis, Fluorescence Imaging Applications and Analysis by Storm and Typhoon Fluorimager, Genotyping (RFLP, Pyrosequencing, TaqMan), Mutation Discovery by Denaturing HPLC (DHPLC).

General and Clinical Microbiology: Routine diagnostic culture methods, Automated Microbial Identification, Genetic Probes: Preparation and utilization, Nucleic Acid Hybridization for Identification and Detection of pathogens and their products; and Lyophilization Method for Preservation of pathogens; Electron Microscopy.

Immunology and Cell Biology: Isolation of PBMC; Separation and Purification of CD4+ and CD8+ Cells; Characterization of Human and Macaque TCR Repertoire by the HTA (Heteroduplex Tracking Analysis); Familiar with Cell Culture; and FACS (Fluorescence Activated Cell Sorter).

Industrial (Pharmaceutical) Microbiology: Microbial Limit Assays; Antimicrobial Preservatives-Effectiveness Test; Sterility Test; Antibiotic-Microbial Assays; Bacterial Endotoxin Test; In Vitro; Pyrogen Test, Ames Test, familiar with cGMP, cGLP guidelines for establishing limits.

Pharmacogenomics Design Assays for different genotyping methods (eg. RFLP, Pyrosequencing, TaqMan, Primer Extension, ABI SNPlex genotyping system…) Whole Genome Analysis, Whole Genome Amplifications, Single Nucleotide Polymorphism (SNP) discovery using DHPLC, Trained on Illumina GoldenGate and Infinium genotyping methods (MicroArray) Apply Robotic systems (Packard MultiProbes, Eppendorf) to automate genotyping processing

Bioinformatics: • Familiar with genomic and protein databases • Knowledge of DNA sequence analysis tools • Experience with analysis of genomic data • Haplotype Inference and analysis

EDUCATION: Ph.D., Microbiology and Immunology 1994-1999 Laval University, Ste-Foy, Quebec, Canada

Master of Science (M.Sc.), Microbiology 1984-1987 Master of Science in Public Health (M.S.P.H.) Tehran University of Medical Sciences, Tehran, Iran.

Bachelor of Science (B.Sc.), Microbiology 1976-1979 University of Texas at Arlington, Arlington, Texas, U.S.A.

TEACHING:

Drug Metabolism, Drug Transporters, and Pharmacogenomics; PHA 6936 Therapeutic and Diagnostic Analysis and Pharmacogenomics; PHA 5113 Clerkship Course PHA 5663 (Cardiovascular Research)

STUDENT ADVISING:

Graduate student Advisor Faculty Advisor

SUPERVISING AND MENTORING:

Postdoctoral Fellows Professional/Undergraduate Research Mentoring UF Minority students

GRANTS AND RESEARCH:

Co-Principal Investigator UF Research and Graduate opportunity Fund Grant (2003) $60,000

Co-Principal Investigator UF Research and Graduate opportunity Fund Grant (2005) $92,500

Co-Investigator U01 HL083459 (PI: Dr. Julie Johnson); 40% Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) 08/2005-09/30/2010: $11,149,034. D $1,352,144; I $262,835; T $1,614,979

Co-Investigator RO1-HL0747000; NIH/HLBI; (PI: Dr. Julie Johnson); 45% 10/01/2003-09/30/2007: D $2,513,387; I $1,004,312 ; T $3,517,699. Hypertension Pharmacogenomics;

Co-Investigator B 0435278 B AHA FL/Peurto Rico Affiliate (PI: Dr. Issam Zineh); (Co-investigator; 5%), 07/2004 to 06/2007: $80,000 American Heart Association National Research Program Systemic Immunomodulatory Effects and Pharmacogentics of Atorvastatin in Early Atherosclerosis

Co-Investigator 5% NIH (National Institute for Environmental Health Science, NIEHS); (PI: Dr.Peter stacpoole); Health Effects of Chlorinated Compounds: Pharmacotoxicology of Trichloroethylene Metabolites 04/01/2005- 03/30/2010: $718,114; $599,527 ; $1,317,641

Co-Investigator R21/R33 NIH Planning Grant (PI; Dr. Frank Catalanotto) 5% 10/01/2007 to 12/31/2008 $50,000 To plan and establish the feasibility of the key technology underlying a planned P50 proposal to support the expanding chemosensory clinical research program of the University of Florida’s Center for Smell and Taste.

Pending

Principal Investigator Investigator initiated research proposal to AstraZeneca Pharmaceutical Company, 10/01/2007 to 11/30/2008 $50,000.00 Effect of CYP3A5 polymorphisms on systemic exposure to Budesonide (Pulmicort Flexhaler)

PUBLICATIONS:

Langaee, T. Y., M. Dargis and A. Huletsky. 1998. An ampD gene in Pseudomonas aeruginosa encodes a negative regulator of AmpC beta-lactamase expression. Antimicrobial Agents And Chemotherapy, Dec. 1998, p. 3296-3300.

Langaee, T. Y., Luc Gagnon and A. Huletsky. 2000. Inactivation of the ampD gene in Pseudomonas aeruginosa leads to moderate basal level and hyperinducible AmpC beta-lactamase expression. Antimicrobial Agents And Chemotherapy, Mar. 2000, p. 583-589.

Langaee TY, and Zineh I.(Book chapter) Applied Molecular and Cellular biology In: Pharmacogenomics: Applications to Patient Care. Published by American College of Clinical Pharmacy (ACCP), August 2004.

Aquilante CL, Lobmeyer MT, Langaee TY, Johnson JA. Johnson, Pharm.D. Comparison of cytochrome P450 2C9 genotyping methods and implications for the clinical laboratory. Pharmacotherapy. 2004; 24(6):720-6.

Julie A. Johnson, Taimour Y. Langaee, Issam Zineh, Amber L. Beitelshees. Caution with β1-adrenergic receptor genotyping. Clinical Pharmacology & Therapeutics. 2004;76(2):185-86.

Hruska MW, Frye RF, Langaee TY. Pyrosequencing Method for Genotyping Cytochrome P450 CYP2C8 and CYP2C9 Enzymes. Clin Chem. 2004 Dec;50(12):2392-5.

Hruska MW, Amico JA, T. Y. Langaee, Ferrell RE, Fitzgerald SM, Frye RF. The Effect of Trimethoprim on CYP2C8 Mediated Rosiglitazone Metabolism in Human Liver Microsomes and Healthy Subjects. Br J Clin Pharmacol. 2005 Jan;59(1):70-79.

Taimour Langaee and Mostafa Ronaghi. Genetic Variation Analyses by Pyrosequencing. Mutation Research. (2005); 573(1-2):96-102.

Mostafa Ronaghi and Taimour Langaee. Single Nucleotide Polymorphism: Discovery, Detection and Analysis. Personalized Medicine (2005) 2(2), 111-125.

Aquilante CL, Langaee TY, Lopez LM, Yarandi HN, Tromberg JS, Mohuczy D, Gaston KL, Waddell CD, Chirico MJ, Johnson JA. Influence of coagulation factor, vitamin K epoxide reductase complex subunit 1, and cytochrome P450 2C9 gene polymorphisms on warfarin dose requirements. Clin Pharmacol Ther; 2006; 79:291-302.

Issam Zineh, Gregory J Welder, Taimour Y Langaee. Development and Cross-Validation of Sequencing-Based Assays for Genotyping Common Polymorphisms of the CXCL5 Gene. Clinica. Chemica. Acta 2006 Mar 27; [Epub ahead of print]

Issam Zineh,, Christina L. Aquilante, Taimour Y. Langaee, Amber L. Beitelshees, Christopher B. Arant, Timothy R. Wessel, Richard S. Schofield. CXCL5 gene polymorphisms are related to systemic concentrations and leukocyte production of epithelial neutrophil-activating peptide (ENA-78); Cytokine 2006 Mar 24; [Epub ahead of print]

Christina L. Aquilante, Taimour Y. Langaee, Peter L. Anderson, Issam Zineh, Courtney V. Fletcher. Multiplex PCR- Pyrosequencing Genotyping Assay for CYP3A5 Polymorphisms. Clin Chim Acta 2006 May 13; [Epub ahead of print].

Melissa Ortega, T.Y. Langaee, Ph.D., Y. Gong, Ph.D., H. Feng MD MS, J. A. Johnson, PharmD. G protein β3 subunit (GNβ3) Polymorphism and Hypertension.UF Journal of Undergraduate Research,Volume 7, Issue 4 - March/April 2006.

Taimour Y. Langaee, Yan Gong, Hossein Yarandi, David Katz, Rhonda M. Cooper-DeHoff, Carl J, Pepine, Julie A. Johnson. Association of CYP3A5 polymorphisms with hypertension and antihypertensive reponse to verapamil. Clin Pharmacol Ther. 2007 Mar;81(3):386-91.

Yan Gong, Amber L. Beitelshees, Jennifer Wessel, Taimour Y. Langaee, Nicholas J. Schork, Julie A. Johnson*. SNP DISCOVERY AND HAPLOTYPE ANALYSIS OF BK CHANNEL BETA 1 SUBUNIT. Pharmacogenetics and Genomics 2007, 17:267-275.

Maximilian T. Lobmeyer, BS, Yan Gong, PhD, Steven G. Terra, PharmD, Amber L. Beitelshees, PharmD, MPH, Taimour Y. Langaee, PhD, Daniel F. Pauly, MD, PhD, Richard S. Schofield, MD, Karen K. Hamilton, MD, J. Herbert Patterson, PharmD, Kirkwood F. Adams, Jr, MD, James A. Hill, MD, MS, Juan M. Aranda, Jr., MD, and Julie A. Johnson, PharmD, Synergistic polymorphisms of 1- and 2C-adrenergic receptors and the influence on left ventricular ejection fraction response to -blocker therapy in heart failure. Pharmacogenetics and Genomics 2007, 17:277-282.

Shin J, Lobmeyer MT, Gong Y, Zineh I, Langaee TY, Yarandi H, Schofield RS, Aranda JM Jr, Hill JA, Pauly DF, Johnson JA. Relation of beta(2)-adrenoceptor haplotype to risk of death and heart transplantation in patients with heart failure. Am J Cardiol. 2007 Jan 15;99(2):250-5.

Martin Bruner, Rhonda M. Cooper-DeHoff, Yan Gong, Jason H. Karnes, Taimour Y. Langaee, Carl J. Pepine, Juli A. Johnson. Factors Influencing Blood Pressure Response to Trandolapril Add-on Therapy in Patients taking Verapamil SR (From the International Verapamil SR/Tandolapril [INVEST] Study). American Journal of Cardiology (In press).

Gary M. Levin, Toya M. Bowles, Megan J.Ehrel, Taimour Y. Langaee, Jennifer Y. tan, Julie A. Johnson, and William Millard. Assessment of Human Serotonin 1A Receptor Polymorphisms and SSRI responsiveness. Mol Diag Ther 2007 (In press).

Amber L. Beitelshees, Yan Gong, Nicholas J. Schork, Rhonda M. Cooper-DeHoff, Taimour Y. Langaee, Mark D. Shriver, Carl J. Pepine, Julie A. Johnson. KCNMB1 genotype influences response to verapamil SR and adverse outcomes in the INternational VErapamil SR/Trandolapril STudy (INVEST); (In press).

Tobias Gerhard, Yan Gong, Amber L. Beitelshees, Maximilian Lobmeyer, Rhonda M. Copper-DeHoff, Taimour Y. Langaee, Nicholas J. Schork, Carl J. Pepine, Julie A. Johnson. Association between Cardiovascular Outcomes, Diuretics Therapy and the α-adducin Polymorphism: Results from the International Verapamil STudy GENEtic substudy (INVEST- GENES), (Submitted, 2007)

Yan Gong, Amber L. Beitelshees, Taimour Y. Langaee, Rhonda M. Cooper-DeHoff, Carl J. Pepine, Julie A. Johnson. β2 ADRENERGIC RECEPTOR POLYMORPHISMS ARE ASSOCIATED WITH RESPONSE TO β-BLOCKER THERAPY: RESULTS FROM THE INVEST GENETIC SUBSTUDY (INVEST GENES). (Submitted, 2007).

Jennifer R. Dungan, Taimour Y. Langaee, Yvette P. Conley, Julie A. Johnson, Shawn M. Kneipp, Philip J. Hess, & Carolyn B. Yucha. DIFFERENTIAL ALPHA1A AND BETA2 ADRENERGIC RECEPTOR GENE EXPRESSION IN CLINICAL HYPERTENSION(Submitted, 2007).

Issam Zineh, Amber L Beitelshees, Christina L Aquilante, Hooman Allayee, Taimour Langaee, Gregory J Welder, Richard S Schofield. CXCL5 Polymorphisms are Associated with Variable Blood Pressure in Cardiovascular Disease-Free Adults. (Submitted 2007).

Mustafa Hassan, Kaki M. York, Haihong Li, Qin Li,Yan Gong, Taimour Y. Langaee, Roger B. Fillingim, Julie A. Johnson, | David S. Sheps. ß-Adrenergic Receptor Polymorphisms Predict Hemodynamic and Myocardial Ischemic Responses to Mental Stress in Patients with Coronary Artery Disease (Submitted, 2007).

Membership

American Society for Clinical Pharmacology and Therapeutics (ASCPT) American Society of Human Genetics (ASHG)

AWARDS:

1996 ASM (American Society for Microbiology) Sustaining Member Student Grant. 1997 ASM (American Society for Microbiology) Sustaining Member Student Grant.

ABSTRACTS AND PRESENTATIONS:

I Zineh, PharmD, TY Langaee, PhD, JA Hill, MD, MS, DF Pauly, MD, PhD, RS Schofield, MD, JM Aranda, Jr., MD, and JA Johnson, PharmD. Type-A Natriuretic Peptide Receptor Polymorphism in Hypertension, Heart Failure Prognosis, and Response to Nesiritide. Presented as a poster at the 2002 American College of Clinical Pharmacy Meeting, Cardiology Practice and research Network, Albuquerque, NM, October 2002.

A. Albekairy, Pharm.D. , T. Luu, H. Yarandi, Ph.D., T. Y. Langaee, Ph.D., C. Formea, Pham.D., V. Greene, PA., S. Fujita, MD., W. Vander Werf, MD., A. Hemming, MD, R. Howard, MD., A. Reed, MD., J. Karlix, Pharm.D., University of Florida, College of Pharmacy and medicine, Gainesvlle, FL. CYTOCHROME P-450 3A4*1B AS PHARMACOGENOMIC PREDICTOR OF TACROLIMUS PHARMACOKINETICS AND CLINICAL OUTCOME IN THE LIVER TRANSPLANT RECIPIENTS. Presented as a poster at the 2002 American College of Clinical Pharmacy Meeting, Cardiology Practice and research Network, Albuquerque, NM, October 2002.

R.P. Rantinella, T.Y. Langaee Ph.D., C. Aquilante PharmD., J.A. Johnson PharmD., University of Florida College of Pharmacy, Gainesville, FL. Association of Alpha 2b-Adrenergic Receptor Insertion/Deletion Polymorphism with Hypertension and Obesity. Selected for a poster presentation at the 104th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT). Marriott Wardman Park Hotel, Washington, DC. April 2-5, 2003.

Aquilante CL, Yarandi HN, Langaee TY, Tromberg JS, Lopez LM, Waddell CD, Johnson JA. University of Florida, College of Pharmacy and medicine, Gainesvlle, FL. The Influence of Coagulation Factor and CYP2C9 Polymorphisms on Warfarin Dose. Abstract was accepted by American Heart Association and will be presented at the American Heart Association meeting, Orlando, Florida, November 9-12, 2003.

TM Bowles, PhrmD., GM Levin, PharmD., TY Langaee, Ph.D., JY Tan, PharmD., HN Yarandi, Ph.D., JA Johnson, PharmD., WJ Millard, Ph.D. Assessment of serotinin type1A (5-HT1A) receptor genotype in a normal versus a depressed population and the relationship to predictability of antidepressant responsiveness. Abstract was accepted by American College of Clinical Pharmacy (ACCP) and will be presented at the 2003 American College of Clinical Pharmacy Meeting, Atlanta, GA, November 2-5, 2003.

Aquilante CL, Yarandi HN, Langaee TY, Tromberg JS, Lopez LM, Waddell CD, Johnson JA. The Influence of Coagulation Factor and CYP2C9 Polymorphisms on Warfarin Dose. University of Florida, College of Pharmacy and medicine, Gainesvlle, FL. Presented at the Annual Meeting of the American Heart Association (AHA) Meeting, Orlando, FL, November 2003.

T. Y. Langaee, PhD., R. C. Givens, BS, A. Sloan, MS., P. B. Watkins, MD., J. A. Johnson, PharmD. ASSOCIATION OF CYP3A5*3, *6, AND *7 POLYMORPHISMS WITH HYPERTENSION. University of Florida, Gainesville, FL, University of North Carolina, Chapel Hill, NC. Abstract was accepted by American Society for Clinical Pharmacology and Therapeutics (ASCPT) and presented at the 2004 American Society for Clinical Pharmacology and Therapeutics Meeting, Miami Beach, FL, March 25, 2004.

Gaston KL, Aquilante CL, Langaee TY, Lopez LM, Johnson JA. Vitamin K epoxide reductase polymorphisms rare in warfarin-treated population. Pharmacotherapy 2004; 24(10): 1458

J. R. Dungan, RN, MSN, ARNP, T.Y. Langaee, MSPH, PhD, J. A. Johnson, Pharm.D., and C. B. Yucha, PhD, RN. Exploring the Relationship Between Beta-2 Adrenergic Receptor Gene Polymorphisms and Biofeedback Outcomes in Hypertension. University of Florida, College of Pharmacy and medicine, Gainesvlle, FL. Abstract was accepted by Association for Applied Psycophysiology and Biofeedback (AABP) and will be presented at the 2004 Association for Applied Psychophysiology and Biofeedback Meeting, Colorado Springs, CO, April, 2004.

B.S. Belgado, L.H. Cavallari, T. Langaee, T. Okorochukwu J. A. Johnson, PharmD. ASSOCIATION OF ß2-Adrenergic Receptor Haplotype and Hypertension in African-Americans and Caucasians. University of Florida, Gainesville, FL, University of Illinois at Chicago, College of Pharmacy. Abstract was accepted by American Society for Clinical Pharmacology and Therapeutics (ASCPT) and presented at the 2004 American Society for Clinical Pharmacology and Therapeutics Meeting, Miami Beach, FL, March 25, 2004.

C. Formea, PharmD., T. Luu, BS, A. Albekairy, PharmD., H. Yarandi, Ph.D., T. Langaee, Ph.D., V. Freene, PA., S. Fuijita, MD., W. Van der Werf, MD., A. Hemming, MD., R. Howard, MD.,Ph.D., A. Reed, MD., J. Karlix, PharmD. Cytochrome P-450 3A4, 3A5, and MDR-1 As Pharmacogenomic Predictors of Tacrolimus Pharmacokinetics And Clinical Outcomes in Liver Transplant recipients. University of Florida, Gainesville, FL. Abstract was accepted by American Society for Clinical Pharmacology and Therapeutics(ASCPT) and presented at the 2004 American Society for Clinical Pharmacology and Therapeutics Meeting, Miami Beach, FL, March 25, 2004.

Zineh I, Luo X, Langaee TY, Johnson JA, Chegini N. Th1- and Th2-related cytokine and chemokine balance in blood pressure responders and non-responders to metoprolol monotherapy. Pharmacotherapy 2004;24(10):1427.

Hruska MW, Cheong JA, Amico JA, Langaee TY, Frye RF. Effect of CYP2C8 Genotype on rosiglitazone pharmacokinetics. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, Orlando, FL, March 2005 and Clin Pharmacol Ther 2005; in press.

Hruska MW, Cheong JA, Langaee TY, Frye RF. Effect of St. John’s Wort Administration on CYP2C8 Mediated Rosiglitazone Metabolism. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, Orlando, FL, March 2005 and Clin Pharmacol Ther 2005; in press.

B.S. Belgado, L.H. Cavallari, T. Langaee, T. Okorochukwu J. A. Johnson, PharmD. ASSOCIATION OF ß2-Adrenergic Receptor Haplotype and Hypertension in African-Americans and Caucasians. Clin Pharmacol Ther 2004;75(2):P95.

C. Formea, PharmD., T. Luu, BS, A. Albekairy, PharmD., H. Yarandi, Ph.D., T. Langaee, Ph.D., V. Freene, PA., S. Fuijita, MD., W. Van der Werf, MD., A. Hemming, MD., R. Howard, MD.,Ph.D., A. Reed, MD., J. Karlix, PharmD. Cytochrome P-450 3A4, 3A5, and MDR-1 As Pharmacogenomic Predictors of Tacrolimus Pharmacokinetics And Clinical Outcomes in Liver Transplant recipients. Clin Pharmacol Ther 2004;75(2):P39.

Zineh I, Luo X, Langaee TY, Johnson JA, Chegini N. Th1- and Th2-related cytokine and chemokine balance in blood pressure responders and non-responders to metoprolol monotherapy. Pharmacotherapy 2004;24(10):1427.

Hruska MW, Cheong JA, Amico JA, Langaee TY, Frye RF. Effect of CYP2C8 Genotype on rosiglitazone pharmacokinetics. Clin Pharmacol Ther 2005;77(2):P36.

Hruska MW, Cheong JA, Langaee TY, Frye RF. Effect of St. John’s Wort Administration on CYP2C8 Mediated Rosiglitazone Metabolism. Clin Pharmacol Ther 2005;77(2):P35.

Hudson AA, Zineh I, Yarandi HN, Langaee TY, Pauly DF, Johnson JA. Angiotensin system polymorphisms and traditional risk factors as predictors of heart failure prognosis. Clin Pharmacol Ther 2005;77(2):P63.

Gong Y, Beitelshees AL, Stauffer L, Gaston K, Sloan A, Yarandi HN, Langaee TY, Cooper-DeHoff RM, Pepine CJ, Johnson JA. BETA 2- ADRENERGIC RECEPTOR (B2AR) POLYMORPHISMS AND ANTIHYPERTENSIVE RESPONSE TO BETA-BLOCKER THERAPY IN THE INVEST TRIAL. Clin Pharmacol Ther 2005; 77 (2): P22. ACTIVE GRANTS/CONTRACTS

Zineh I, Langaee TY, Welder GJ, Luo X, Arant CB, Wessel TR, Schofield RS, Chegini N. eNOS polymorphism is associated with early inflammation in normocholesterolemic patients. Pharmacotherapy 2005;25(3):473.

Zineh I, Arant CB, Wessel TR, Langaee TY, Welder GJ, Schofield RS. Apolipoprotein B/A ratio within the normal range is associated with elevated C-reactive protein in apparently healthy women. Pharmacotherapy 2005;25(3):453.

Hruska MW, Cheong JA, Amico JA, Langaee TY, Frye RF. Effect of CYP2C8 Genotype on rosiglitazone pharmacokinetics. Clin Pharmacol Ther 2005;77(2):P36.

Hruska MW, Cheong JA, Langaee TY, Frye RF. Effect of St. John’s Wort Administration on CYP2C8 Mediated Rosiglitazone Metabolism. Clin Pharmacol Ther 2005;77(2):P35.

Hudson AA, Zineh I, Yarandi HN, Langaee TY, Pauly DF, Johnson JA. Angiotensin system polymorphisms and traditional risk factors as predictors of heart failure prognosis. Clin Pharmacol Ther 2005;77(2):P63.

Gong Y, Beitelshees AL, Stauffer L, Gaston K, Sloan A, Yarandi HN, Langaee TY, Cooper-DeHoff RM, Pepine CJ, Johnson JA. BETA 2- ADRENERGIC RECEPTOR (B2AR) POLYMORPHISMS AND ANTIHYPERTENSIVE RESPONSE TO BETA-BLOCKER THERAPY IN THE INVEST TRIAL. Clin Pharmacol Ther 2005; 77 (2): P22. ACTIVE GRANTS/CONTRACTS

T.Y. Langaee, H.N. Yarandi, D. Katz, R.M. Dehoff, J.M. Kehoe, A.S. Klocman, C.J. Pepine, J.A. Johnson. DIFFERENCES IN VERAPAMIL RESPONSE BETWEEN CYP3A5 GENOTYPES. Clin Pharmacol Ther 2006;79(2):P12.

I. Zineh, T.Y. Langaee, T.R. Wessel, C.B. Arant, R.S. Schofield. Influence of SLCO1B1 (OATP1B/OATP-C) gene polymorphisms on cholesterol responses to Atorvastatin. Clin Pharmacol Ther 2006;79(2):P5.

M. Bruner, J.H. Karnes, Y. Gong, T.Y. Langaee, R.M. Cooper-Dehoff, C.J. Pepine, J.A. Johnson. Association of Angiotensin II type I receptor (AGTR1) 1166A>C polymorphism with blood pressure response to ACE inhibitor in a subgroup of patients of the International Verapamil SR/Trandolapril Study (INVEST). Clin Pharmacol Ther 2006;79(2):P14.

D.L. Kroetz, Z. Yu, T.Y. Langaee, J.A. Johnson. Functionally significant variants of CYP2J2 and EPHX2 are not associated with hypertension. Clin Pharmacol Ther 2006;79(2):P15.

Y. Gong, A.L. Beitelshees, L.A. Stauffer, T.Y. Langaee, R.M. Cooper-Dehoff, C.J. Pepine, J.A. Johnson. Beta Adrenergic Receptors polymorphisms are associated with response to beta-blocker therapy in the International Verapamil SR/Trandolapril Study (INVEST). Clin Pharmacol Ther 2006;79(2):P130.

J. Shin, M.T. Lobmeyer, Y. Gong, I. Zineh, T.Y. Langaee, H.N. Yarandi, D.F. Pauly, J.M. Aranda, R.S. Schofield, J.A. Hill, J.A. Johnson. A haplotype of Beta2- Adrenoceptor is associated with the increased risk for transplant or death in heart failure patients. Clin Pharmacol Ther 2006;79(2):P30.

J.A. Johnson, J.H. Karnes, M. Bruner, Y. Gong, T.Y. Langaee, R.M. Cooper-Dehoff, C.J. Pepine. Association of Lack of association of the Angiotensin II type I receptor (AGTR1) 1166A>C polymorphism with cardiovascular and cerebrovascular outcomes in a subgroup of patients of the International Verapamil SR/Trandolapril Study (INVEST). Clin Pharmacol Ther 2006;79(2):P43.

I. Zineh, C.L. Aquilante, T.Y. Langaee, A. L. Beitelshees, T.R. Wessel, C.B. Arant, R.S. Schofield. Association of CXCL5 polymorphisms with plasma and leukocyte-produced epithelial neutrophil-activating peptide (ENA-78) concentrations. Clin Pharmacol Ther 2006;79(2):P59.

Pacanowski MA, Gong Y, Langaee TY, Cooper-DeHoff RM, Schork NJ, Pepine CJ, Johnson JA. β2-adrenergic receptor polymorphisms and antihypertensive treatment outcomes in the INternational VErapamil SR/ trandolapril STudy – GENEtic Substudy (INVEST-GENES). [abstract] Clin Pharmacol Ther 2007;81(S1):S34. Presented as a poster at the American Society for Clinical Pharmacology and Therapeutics 108th Annual Meeting, Anaheim, CA, March 2007.

T.Y. Langaee, B. Burkley, Y. Gong, I. Zineh. EFFECTS OF CYP3A4 AND CYP3A5 POLYMORPHISMS ON CHOLESTEROL RESPONSES TO ATORVASTATIN. [abstract] Clin Pharmacol Ther 2007;81(S1):S89. Presented as a poster at the American Society for Clinical Pharmacology and Therapeutics 108th Annual Meeting, Anaheim, CA, March 2007.

Resume of William Cary Mobley, Ph.D., R.Ph.

Home Address: (for correspondence) Work Address: 3201 NW 38TH St., University of Florida College of Pharmacy Gainesville, Florida 32608 Department of Pharmaceutics Phone: (352)378-7838 JHMHC Box 100494 e-mail: [email protected] Gainesville, FL 32610 Phone: (252)273-6282 e-mail: [email protected]

Education 1994 Ph.D. in Pharmaceutics from the University of Florida College of Pharmacy Thesis Title: “The Physical Characterization of Lyophilized Liposomes” 1985 B.S. with Honors in Pharmacy from the University of Florida 1980 B.S. in Biology from the University of Miami – Coral Gables, FL

Employment 5/05-current Clinical Associate Professor, Director of Pharmacy Skills Training Curriculum University of Florida College of Pharmacy 6/02-5/05 Clinical Assistant Professor, University of Florida College of Pharmacy 9/00- 6/02 Assistant Professor in Pharmaceutical Sciences and Facilitator, Nova Southeastern University College of Pharmacy – W. Palm Beach Distance Pharmacy Education Program 9/98-9/00 Assistant Professor in Pharmaceutical Sciences, Nova Southeastern College of Pharmacy. Davie, Florida 10/94-9/98 Assistant Professor in Pharmaceutical Sciences, Idaho State Univ. College of Pharmacy 1/94-8/94 Visiting Assistant in Postdoctoral Program, U.F. College of Pharmacy 8/88-5/94 Research and Teaching Assistant at U.F. Department of Pharmaceutics 12/86-2/92 Chief, Staff, and Relief Pharmacist at Wal-Mart – Gainesville, Florida 5/85 to 12/86 Chief and Staff Pharmacist at Walgreens – Orlando, FL and Ocala, FL

Consultant 2003-current Consultant, Writer, and Instructor for the Certificate Training Program: The Science of Pharmaceutical Compounding co-sponsored by UF College of Pharmacy and Medisca, Inc. 2006 Reviewer, PCAT Practice Test – Quantitative Section Reviewer, Journal of Liposome Research 2004 Consultant on pharmacy compounding related matters for Mager and Associates, Inc. Attorneys 2004 Consultant on pharmacy compounding course design and management – Idaho State University College of Pharmacy 1998-2002 Consultant for Clickpharmacy.com (an internet pharmacy) –Consulted on business model development and website design, and wrote policies and procedures for pharmacy operations

Teaching Experience 2006 Designer, Writer, Coordinator and Facilitator for 2PD Interprofessional Case Studies Pilot Program with the Medical School 2002-current Coordinator and Instructor for Dosage Forms II and for Pharmacy Compounding Designer, Writer, Coordinator and Facilitator for 1PD and 2PD Integrated Case Studies 2005 - current Coordinator and Instructor for Dosage Forms I 2004, 2006 Coordinator and Instructor for Drug Stability (Graduate program) 2005-2007 Facilitator for Interdisciplinary Family Health Program 2002-2003 1998-2002 Coordinator and Instructor for Dosage Formulation, Drug Delivery, Pharmacy (Nova University) Compounding, Pulmonary Drug Delivery. Designed and equipped a new Pharmacy Compounding lab for the W. Palm Beach Pharmacy Program 1994-1998 Coordinator and Lecturer for Pharmaceutics: Pharmaceutical Preformulation, (Idaho State Univ.) Pharmaceutical Analysis, Biopharmaceutics, Pharmacy Calculations, Dosage Formulation, Drug Delivery, Pharmacy Compounding, and Pharmaceutical Biotechnology. (All lectures are in HTML format for Internet access and delivery. Lecture experience includes live videoconference lectures and asynchronous videostreamed lectures) 1996-1998 Facilitator for Cases Studies (Idaho State Univ.) Graduate Seminar in Pharmaceutics - Coordinator 1994 Pharmaceutics: Dosage Forms and Drug Delivery Systems (Univ. of Florida) 8/88-5/91 Teaching Assistant in the Compounding and Pharmaceutical Analysis labs, and Pharmaceutics Discussion Groups

Research Experience Main interests: (1) Development of liposome powders for pulmonary drug delivery. (2) Development of a liposome-cholera toxin conjugate for oral vaccine delivery. (3) Development of hypertext methods for facilitating curricular integration.

Technical experience FTIR spectroscopy Lyophilization Liposome preparation and characterization Differential scanning calorimetry Chromatography Gel electrophoresis Thermogravimetry Radiochemistry Western blot Electron microscopy Dialysis Sterile techniques UV and fluorescence spectroscopy Dynamic light scattering Centrifugation

Publications Journal Articles L. D. Reid, C. Motycka, C. Mobley, M. Meldrum (2006) Comparing Self-reported Burnout of Pharmacy students on the Founding Campus with Those at Distance Campuses. Amer. J. Pharmaceutical Edu. 70 (5) Article 114. C. T. Ward, J. A. Rey, W. C. Mobley, C. D. Evans, (2003) Establishing a distance learning site for a traditional doctor of pharmacy program. Am. J. of Pharmaceutical Educ. 67:article 20. C. Mobley (2002) Adaptation of a hypertext pharmaceutics course for long-distance pharmacy education. Am. J. of Pharmaceutical Educ. 66:140-144. C. Mobley and G. Hochhaus (2001) Methods to assess the pulmonary deposition and absorption for drugs for the treatment of respiratory disease. Drug Discovery Today. 6:367-375. W. C. Mobley (1998) The effect of jet-milling on lyophilized liposomes. Pharmaceutical Res. 15:149-152. W.C. Mobley and H. Schreier (1994) Phase transition temperature reduction and glass formation in dehydroprotected lyophilized liposomes. J. Contr. Rel. 31:73-87. H. Schreier, W.C. Mobley, N. Concessio, A.J. Hickey and R.W. Niven (1994) Formulations and in vitro performance of liposome powder aerosols. STP. Pharma Sci. 4:38-44.

Book Chapters M. Issar, C. Mobley, P. Khan, G. Hochhaus (2004) Pharmacokinetics and pharmacodynamics of drugs delivered to the lungs in Pharmaceutical Inhalation Aerosol Technology, 2nd Ed. AJ Hickey Ed. C. Mobley and G. Hochhaus (2001) Pharmacokinetic considerations in the design of pulmonary drug delivery systems for glucocorticoids in Drug Targeting Technology: A Critical Analysis of Physical, Chemical, and Biological Methods. H. Schreier, Ed., Marcel Dekker. pp. 51-84

Continuing Education C. Mobley (2003) Anatomical and physiological considerations for pharmacy compounding. Drug Topics, 147:64.

Abstracts Pharm. Res. 10 (Suppl.) s266 (1993) Proceed. Intern. Symp. Control. Rel. Bioact. Mater., 19, 250-251 (1992) Pharm. Res., 9 (Suppl.) s 226 (1992)

Other 2000 Wrote Policies and Procedures for Clickpharmacy.com (an internet pharmacy) that helped the company obtain a VIPPS seal by the National Association of the Boards of Pharmacy.

Presentations Poster 2007 AACP Annual Meeting, Orlando, FL 2005 AACP Annual Meeting, Cincinnati, OH 1997 Colorado Biopharmaceutical Delivery Conference, Breckenridge, CO 1993 AAPS Annual Meeting and Exposition, Orlando, FL 1992 AAPS Annual Meeting and Exposition, San Antonio, TX 9th International Symp. on the Controlled Release of Bioactive Materials, Orlando, FL AAPS S.E. Regional Meeting- Wilmington, N.C. 2nd Annual Liposome Research Days- Leiden, Netherlands 5th Annual Excellence in Research Competition, U.F. College of Pharmacy

Computer 1998 “Hyperlinking to facilitate lecturing and curricular integration” American Association of Colleges of Pharmacy Annual Meeting, Aspen, CO

Other 2007 Keynote Address to the UF College of Pharmacy Awards Ceremony – Jacksonville Campus 2005 Presentation about the Skills Lab to the UF College of Pharmacy National Advisory Board 1998 Facilitator of the Glaxo Pathway Evaluation Program for Pharmacy Professionals (for Nova University pharmacy students) 1996 Facilitator of the Glaxo Pathway Evaluation Program for Pharmacy Professionals (for I.S.U. pharmacy students)

Other Meeting Activities 2007 Alternate Delegate to American Association of Colleges of Pharmacy Annual Meeting, Orlando, FL 2006 Poster Judge for SERIS Meeting, Gainesville, FL 2005 Poster Judge for 18th Annual College of Pharmacy Research Showcase 2005 Attended UF College of Agricultural and Life Sciences Teaching Workshop: Creating Virtual Labs 2005 Attended Practical Application of General Chapter <797> by USP, San Francisco, CA 2005 Attended AACP Institute: Preparing Pharmacy Graduates for the Future , Lansdowne, Virginia 2004 Delegate to American Association of Colleges of Pharmacy Annual Meeting, Salt Lake City, Utah 2003 Attended AACP Institute: Assessing Student Performance, Lansdowne, Virginia

Grants and Contracts Awarded 1999 Principle Investigator - Nova Southeastern University Internal Research Grant- “Investigation of a Liposome - Cholera Toxin B Conjugate Intended as an Oral Vaccine Adjuvant ($5000) 1996 Principle Investigator - Accumetrics, Inc.- “Feasibility of Producing Protein-Coated Large Unilamellar Liposomes” ($835 contract) 1995 Principle Investigator - I.S.U. Faculty Research Committee Grant- “Marker-Retaining Ability of Liposomes During Jet-Milling” ($3970)

Not Awarded 2001 Collaborator - Dept. of Health and Human Services Public Health Service – “Studies on the Regulation of VEGF Gene Expression”. Principle Investigator – A. Rathinavelu – Nova Southeastern University. ($686,209) 1997 Principle Investigator - AACP New Investigator Grant- “Development of a Liposome- Cholera Toxin Conjugate for Oral Vaccine Delivery” 1996 Principle Investigator - Idaho State Board of Education- “Development of a Hypertext Model for Integrating Basic Sciences with Pharmaceutical Sciences at ISU College of Pharmacy” 1996 Principle Investigator - AACP New Investigator Grant- “Development of a Liposome- Cholera Toxin Conjugate for Delivery to Peyer’s Patches” 1996 Principle Investigator - Pharmaceutical Researchers and Manufacturers of America Foundation Research Starter Grant- “Stability of Jet-Milled Lactate Dehydrogenase: Towards the Development of Therapeutic Proteins for Lung Administration”

Honors and Awards 2007 Teacher of the Year - U.F. College of Pharmacy 2006 Nominated, Teacher of the Year - U.F. College of Pharmacy 2002 Teacher of the Year W. Palm Beach (Nova Southeastern University College of Pharmacy) 1999 P1 Male Teacher of the Year (Nova Southeastern University College of Pharmacy) 1996, 1997 Nominated, Teacher of the Year (I.S.U. College of Pharmacy) 1992 1st Place Senior Division, Oral Competition Section, 5th Annual Excellence in Research Competition (University of Florida College of Pharmacy) 1990 Teaching Assistant of the Year (University of Florida College of Pharmacy)

Academic Committees University of Florida 2006 – current Active Learning Ad hoc Committee 2003 - current Curriculum Committee – maintain updated outcomes revisions for the committee, created email survey to assess active learning 2003 - current Assessment Committee 2005 - 2006 Masters in Medication Therapy Management ad hoc Committee 2005- 2006 Pharmacy Skills ad hoc Committee Nova University 1999-2002 Admissions Committee 1999 Patient Care Management Committee I.S.U. 1997-1998 Pharmaceutical Sciences Faculty Search Committee 1997-1998 Curricular Affairs Committee 1997-1998 Faculty Affairs Committee 1996-1998 I.S.U. Academic Standards Council 1996-1997 General Collection and Government Documents Committee 1995-1997 Graduate Education and Faculty Research Affairs Committee 1995-1996 Writing Assessment Committee

Professional Memberships 2002-current Alachua County Association of Pharmacists 1994-current American Association of Colleges of Pharmacy 2006-2007 American Association of Health-Systems Pharmacists 1982-current Kappa Psi Pharmaceutical Fraternity 1983-current Rho Chi Society 1988-2002 American Association of Pharmaceutical Scientists

Professional Licensure 1985-current Florida Registered Pharmacist

Extracurricular Activities 2003-current Soccer and Basketball Coach, St. Patrick Interparish School / YMCA 2005 Judge - 18th Annual College of Pharmacy Research Showcase poster competition 1998 Soccer Coach- Pocatello, ID 1996,1998 Science Fair Judge, Indian Hills Elementary School 1995-1996 Assistant Soccer Coach- Pocatello, ID

ANTHONY PALMIERI III, Ph.D.

University of Florida Office: (352) 273-7868 Department of Pharmaceutics P4-31 1600 SW Archer Road JHMHC Gainesville, Florida 32610 E mail: [email protected]

BACKGROUND SUMMARY

Presently on the faculty at the University of Florida College of Pharmacy in the Department of Pharmaceutics. Twenty-five years of progressive responsibilities in an intellectual property management and technology transfer position coupled with ten years as a professor of pharmaceutics at major universities. Demonstrated and proven ability to set a vision, goals and direction of a department. Demonstrated leadership skills in a departmental and organizational setting. Successfully led projects across management lines where reporting relationships were often difficult to establish, no precedent existed and the use of creative problem solving and communication skills were necessary. President of a national scientific academy and a major inter-fraternal organization including setting a vision and goals for these organizations during a critical growth period. Author of over 80 publications and presentations on intellectual property, pharmaceutics, pharmacy education and the history of pharmacy. Has interacted extensively with USAN and WHO to obtain non-proprietary names for Pharmacia and Upjohn. Currently Chairman of the USAN Council. Consultant and Expert Witness on patent litigation involving controlled release dose forms, excipients, bioequivalence, for numerous litigations. Expert witness for Pentech Pharmaceuticals before the Office of Generic Drugs.

PROFESSIONAL EXPERIENCE

UNIVERSITY OF FLORIDA 2000 – Present

Assistant Clinical Professor of Pharmaceutics 2006 - Present Responsibilities include advising on intellectual property, teaching graduate and undergraduate courses in clinical biochemistry, dose form design, sustained release and dissolution.

Assistant Director, Office Technology Licensing 2000 - 2006 Evaluating the University’s intellectual property portfolio in the life sciences and providing assistance in the protection and marketing of this intellectual property. Negotiating and drafting legal documents including license agreements, option agreements, stock agreements, materials transfer agreements, confidential disclosure agreements and/or providing guidance and oversight in the drafting of such agreements. Coordinating licensing activities with the intake of new invention disclosures and with the patent prosecution of new disclosures. Managing the University’s active licenses and contractual obligations in the assigned areas in the life sciences.

ANTHONY PALMIERI III, Ph.D. Page 2 of 12 PHARMACIA & UPJOHN, Kalamazoo, Michigan 1984 – 2000

Manager, Technology Protection Managed three Ph.D. professionals responsible for providing accurate, critically evaluated, concise, strategic patent information concerning company and competitor patents. Evaluated commercial potential of inventions, and educated the scientific community on intellectual property issues. Determined patentability of inventions. Made decisions and recommendations on filing worldwide patents, USAN names, INN names. Reviewed publications prior to release outside of the company. Evaluated competitor patented compounds and technologies as potential acquisitions. Also evaluated patents considered for in-licensing and served on numerous corporate committees such as the US patent committee, the US Trademark Committee and various process improvement teams. Copyright transfer agent.

Manager, Technology Protection and Tracking 1994 – 1996

Manager, Intellectual Property and Research Contracts 1992 – 1994

Responsibilities included patent decisions, manuscript review, negotiation of scientific and monetary terms for research and scientific collaborations between Upjohn, other companies, academia and government agencies.

Manager, Intellectual Property, The Upjohn Company 1988 – 1992

Senior Patent Liaison Scientist, The Upjohn Company 1984 – 1988

THE UNIVERSITY OF WYOMING, LARAMIE, Wyoming 1975 – 1984

Associate Professor of Pharmaceutics

PREVIOUS TEACHING RESPONSIBILITIES

Dose Form Design Pharmacy Seminar Calculations Physical Pharmacy Biopharmaceutics and Problems in Pharmacokinetics Pharmacy

ANTHONY PALMIERI III, Ph.D. Page 3 of 12 ADMINISTRATIVE EXPERIENCE

Chair Contributed Papers Section, AIHP (2004-2006) Chair APRS Basic Pharmaceutics Section, APRS (2004-2005) Chair-elect APRS Basic Pharmaceutics Section, APRS (2002-2004) Chair-elect, Contributed Papers Section, Am. Inst. History of Pharmacy. (2002-2004) Councilor, American Institute History of Pharmacy (2002-2004) International officer, Kappa Psi Pharmaceutical Fraternity (1999-2007) Member at-large Basic Pharmaceutics Section, APRS (1999-2001) Plainwell School Board: Vice President and Treasurer (1998-1999) President, Academy of Pharmaceutical Research and Sciences (1990) Councilor, American Institute for the History of Pharmacy (1991-1993) Chairman-Elect, Academy of Pharmaceutical Research and Science (1989) Member, Industrial Advisory Board, University of Rhode Island (1990-2000) Member, Industrial Advisory Board, Creighton University (1991-2000) Chairman, Basic Pharmaceutical Sciences Section APRS-APhA (1988) President, College Fraternity Editors Association (1988-1989) President-elect, College Fraternity Editors Association (1987-1988) Secretary, College Fraternity Editors Association (1986-1987) Treasurer, College Fraternity Editors Association (1985-1986) Member of the Board of Directors, College Fraternity Editors Association (1983-1990) Secretary, Faculty Senate, University of Wyoming (1982-1983) Editor, The Mask of Kappa Psi, a quarterly magazine, circulation 15,000 (1980-1984) Member of various university committees such as the Vice-President for Finance Search Committee, Research Coordination, Health Sciences College Review, University Development, Promotion and Tenure. Chairman of University of Wyoming Graduate School Committee.

MEMBERSHIP IN PROFESSIONAL SOCIETIES

Academy of Pharmaceutical Research and College Fraternity Editors Science Association American Association of Pharmaceutical American Institute of the History of Scientists Pharmacy American Pharmaceutical Association Kappa Psi Pharmaceutical Fraternity Sigma Xi Rho Chi American Association of Colleges of Pharmacy

ANTHONY PALMIERI III, Ph.D. Page 4 of 12 NATIONAL PROFESSIONAL COMMITTEE SERVICE

APhA Handbook of Pharmaceutical Excipients, 2nd ed., Steering Committee Chairman APhA Handbook of Pharmaceutical Excipients 3rd ed., Laboratory Chairman APhA Scientific Affairs Reference Committee Chairman (1992) Kappa Psi, various national committees (1980 -present) APhA Scientific Affairs Policy Committee Chairman (1990) APRS Policy Committee, Chairman (1989-1990) APRS Policy Committee, Vice-Chairman (1988) APhA Policy Advisory Committee (1988) APhA Reference Committee on Scientific Affairs, Chairman (1988) APRS Policy Committee, Vice-Chairman (1988) AIHP Committee on Membership (1987-present) AAPS Professional Affairs Committee (1986-1987) APhA Policy Committee on Educational Affairs (1986-1987) APS Professional Affairs Committee (1985-1986) APS Committee on Public Affairs (1984) CFEA Membership Committee, Chairman (1984) College Fraternity Editors Long-Range Planning Committee (1982-1984) AIHP Committee on Nominations (1983) APS Committee on Resolutions (1983) AIHP Committee on Preservation of Sources, Chairman (1981-1983) AACP Council of Sections Administrative Board, Representative from the Pharmaceutics Sections (1981-1983) APS Monograph Committee for the Handbook of Pharmaceutical Excipients (1977-1983) Academy of Pharmaceutical Sciences Dissolution Methodology Committee (1977)

PROFESSIONAL RECOGNITION AND AWARDS

Fellow, APhA Academy of Pharmaceutical Sciences (1994) Editor Emeritus, THE MASK of Kappa Psi (1994) College Fraternity Editor's Association, Ford Award for outstanding service (1994) University of Rhode Island, College of Pharmacy Leadership Award (1990) Adjunct Professor, Creighton University School of Pharmacy (1991-present) PMA Faculty Fellow (1978) Lederle Pharmacy Faculty Award (1977) University of Wyoming Faculty Professional Growth Award (1977) Bristol Award (1971)

ANTHONY PALMIERI III, Ph.D. Page 5 of 12 PHARMACIST LICENSURE

Rhode Island Georgia EDUCATION

University of Rhode Island, B.S. Pharmacy University of Rhode Island, M.S. Pharmacy University of Georgia, Ph.D. Pharmaceutics

CONTINUING EDUCATION

Covey Seven Habits of Highly Effective People Training Career Development Workshop Assertiveness Training Problem-Solving and Decision-Making Perceptive Management Pharmacology Review Coaching, Counseling, Communications and Conflict Management Communications and Problem-Solving

RESEARCH INTERESTS

Industrial Academic Interactions Pharmaceutical Patents Dose Form Design Microencapsulation and Other Sustained Release Delivery Systems Drug Release from Suppositories History of Pharmacy Development of Student Experiments for the Laboratory Development and Evaluation of Student Admission Methods

GRANTS

Summer Research Fellowship, The University of Wyoming, 1976. Sandoz Research Grant Dissolution of Suppositories, 1982. Various travel grants to attend national and international meetings.

ANTHONY PALMIERI III, Ph.D. Page 6 of 12 REFEREED PUBLICATIONS

1. Palmieri, A., Intellectual Property and the Pharmaceutical Scientist - A View from the Other Side, AM. J. PHARM. ED., 53:353-355 (1989).

2. Palmieri, A., Dissolution of Suppositories V: Effect of Aging on Aspirin Release from Polyethylene Suppositories with and without Crospovidone, DRUG DEV. IND. PHARM., 12:1477 (1986).

3. Palmieri, A., Dissolution of Suppositories IV: Effect of Povidone on Aspirin Release from PEG Bases, DRUG DEV. IND. PHARM., 10:137 (1984).

4. Palmieri, A., John C. Davis, Sr., Portrait of a Rocky Mountain Drug Wholesaling Pioneer, ANNALS OF WYOMING, 55(2): 33 Fall (1983).

5. Palmieri, A., Dissolution of Suppositories III: Effect of Povidone on Acetaminophen Release from PEG Suppositories, DRUG DEV. IND. PHARM., 421 (1983).

6. Palmieri, A., Dissolution of Suppositories and Acetaminophen Release, PHARMACEUTICAL TECHNOLOGY, 6(6): 70 (1982).

7. Palmieri, A. and Humberson, C., Medical Incidents in the Life of Dr. John H. Finfrock, ANAL OF WYOMING, 53(2): 64 Fall 1981.

8. Palmieri, A., Suppository Dissolution Testing: Apparatus Design and Release of Aspirin, DRUG DEV. IND. PHARM., 7:247 (1981).

9. Palmieri, A., A Review of Oxidative Stability of Pharmaceutically Important Compounds, ASIAN J. PHARM. SCI., 2:3 (1980).

10. Palmieri, A., Microencapsulation and Dissolution Parameters of Undecenovanillylamide - A Potential Coyote Deterrent, J. PHARM. SCI., 68:1561 (1979).

11. Palmieri, A., Multivariate Prediction of Academic Success of Transfer Students II: Evaluation of the Predictor Equations, AM. J. PHARM. ED., 43:110 (1979).

12. Palmieri, A., An Undergraduate Experiment in Biopharmaceuticals: The Serum and Urine Assay of Ampicillin Generics, AM. J. PHARM. ED., 43:21 (1979).

13. Palmieri, A., Drug Therapy at a Frontier Fort Hospital, PHARMACY IN HISTORY, 21:31 (1979).

14. Palmieri, A., Effect of Dissolved Oxygen Levels on the Oxidative Degradation of Pyrogallol, J. PHARM. SCI. 67:1338 (1978).

ANTHONY PALMIERI III, Ph.D. Page 7 of 12 15. Palmieri, A., Dissolution of Prednisone Microcapsules in Conditions Simulating the pH of the GI Tract, CAN. J. PHARM. SCI., 12:88 (1977). 16. Palmieri, A., Production of a Coacervate Film for Microcapsule Diffusion Studies, DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 3:309 (1977).

17. Palmieri, A., A Model for Multivariate Prediction of Academic Success of Transfer Studies in Pharmacy School, AM. J. PHARM. ED., 41:264 (1977).

18. Palmieri, A., Lausier, J.M. and Paruta, A.N., Utilization of Deaeration Via Gas Permeation and Oxidative Stabilization of Pyrogallol, DRUG DEVELOPMENT COMMUNICATIONS, 2:171 (1976).

19. Palmieri, A. and Sternson, L.A., A Student Experiment in Biopharmaceutics: The Effect on the Enzymatic Oxidation of Xanthine by Xanthine Oxidase, AM. J. PHARM. ED., 38:541 (1974).

BOOKS AND CHAPTERS IN BOOKS 1. Dissolution Theory, Methodology and Testing. Editor and contributor, Dissolution Technologies, 2007.

2. Voices, A History of the College Fraternity Editors Association, 1998

3. Thirty Years of Scientific Excellence: the American Pharmaceutical Association Academy of Pharmaceutical Research and Science, 1965-1995. APhA (1996).

4. Handbook of Pharmaceutical Excipients, Am. Pharm. Assoc., Chairman US Steering Committee, (1994).

5. Palmieri, A., Introduction to Pharmacokinetics, Pharmat, Inc. - A Continuing Education Course for Pharmacists, Vol. VIII, #16. This course has been updated and formatted for use on the IBM- PC (1986).

6. Palmieri, A. and Luzzi, L.A., "Pharmaceutical Applications of Microcapsules", Chapter 1 in Biomedical Applications of Microcapsules, F. Lim, ed., CRC Text (1984).

7. Palmieri, A., "Wyoming" in the Dictionary of American Medical Biography, M. Kaufman, ed., Greenwood Press (1984).

8. Palmieri, A. and Price, J.C., Microencapsulation: New Techniques and Applications, Chapter 8, "Microencapsulation of Drugs Suspended in Oil, Preparation and Evaluation of Prednisone and Hydrocortisone Microcapsules", T. Kondo, ed., Techno, Inc. (1979).

ANTHONY PALMIERI III, Ph.D. Page 8 of 12 PRESENTATIONS

1. Palmieri, A., Academic Industrial Interactions. Presented at major conferences, Universities and pharmacy schools.

2. Palmieri A., Opportunities for Collaboration Between Academics and Industry. How to Improve Your Chances of Funding, AAPS, November, 1995.

3. Palmieri, A., The Challenges Posed by Mergers and Acquisitions in the Pharmaceutical Industry, An Industrial Perspective, AACP Meeting of Chairs, November 1995.

4. Palmieri, A., Kalamazoo Celery Patent Medicines, American Institute for the History of Pharmacy, March 1995.

5. Palmieri, A. Patents and Inventions, American Chemical Society Great Lakes and Central Joint Meeting, June 1994.

6. Palmieri, A., A Comparison of Ayer's Almanacs, 1880-1894, Am. Institute of the History of Pharmacy, March 1, 1994.

7. Palmieri, A., Academic Industrial Interactions, APRS, March 1994.

8. Palmieri, A., Patent Considerations in Material Transfer Agreement, American Society of Pharmacy Law, Dallas, TX, March 1993.

9. Palmieri, A., Patents and the Industrial-Academic Interface, University of Rhode Island, October 1992, Duquesne 1995, Creighton 1993.

10. Palmieri, A., Industry-Academic Interactions, Vanderbilt University, August 1992. University of Georgia, 1993.

11. Palmieri, A., Biotechnology Drug Development, Distinguished lecturer, Society of Sigma Xi, University of Tennessee, Memphis, May 1992.

12. Palmieri, A., Patents, University of Tennessee, Memphis TN, May 1992.

13. Palmieri, A., Emerging Trends in Biotechnology Drug Development, Sanford University, October 1991.

14. Palmieri, A., Dose Form Patents; presented to Upjohn Drug Delivery Worldwide Conference, Sept 1991.

15. Palmieri, A., Transformation of the Pharmaceutical Sciences, 1941-1991, a symposium, American Institute for the History of Pharmacy, New Orleans, March 11, 1991.

ANTHONY PALMIERI III, Ph.D. Page 9 of 12 16. Palmieri, A., Biotechnology Rationing - A Scientific Perspective, Seminar-by-the-Sea, Newport, RI, February 28, 1991.

17. Palmieri, A., Conference moderator, Globalization of Pharmaceuticals, Washington, DC, Sept. 13-14, 1990.

18. Palmieri, A., Biotechnology, Scientific Considerations for the Pharmacist, University of Wyoming Continuing Education, August 1990.

19. Palmieri, A., Material Transfer Agreements, Statement of Investigator Forms, PMA-NIH Meeting, Washington, D.C., March 1990.

20. Palmieri, A., Intellectual Property and the Pharmaceutical Scientist - One Traitors Perspective. Symposium at the Am. Assoc. of Colleges of Pharmacy, Portland, Oregon, July 9, 1989.

21. Palmieri, A., Intellectual Property in Industry, Duquesne University, March 1989.

22. Palmieri, A., Seminar on Patents and Publications, Control Division of Upjohn, November 7, 1986.

23. Palmieri, A., Seminar on Patents in the Pharmaceutical Sciences, Duquesne University School of Pharmacy, October 1986.

24. Palmieri, A., Influence of Aging on Aspirin Release from PEG Suppositories with and without Crospovidone, APS, Montreal, 1984.

25. Palmieri, A., The Hamlin Wizard Oil Songbook - An Example of Early Twentieth Century Advertising, AIHP, Montreal, 1984.

26. Palmieri, A., John C. Davis, Sr.: Portrait of a Rocky Mountain Drug Wholesaling Pioneer, 1901- 1909, AIHP, New Orleans, 1983.

27. Palmieri, A., Dissolution of Suppositories IV: Effect of Crospovidone on Aspirin Release from PEG Bases, APS, New Orleans, 1983.

28. Palmieri, A., Dissolution from Suppositories, Fifteenth Annual Industrial Pharmacy Conference, Madison, Wisconsin, 1982. 29. Palmieri, A., Patent Medicine Advertising, Annual Meeting of the Wyoming Pharmaceutical Association, Cheyenne, WY, 1982.

30. Palmieri, A., Dissolution of Suppositories III: Effect of Crospovidone on Acetaminophen Release, APS Meeting, Las Vegas, 1982.

31. Palmieri, A. and Humberson, C., An Early Wyoming Ranch Medicine Kit, AIHP Meeting, Las Vegas, 1982. ANTHONY PALMIERI III, Ph.D. Page 10 of 12

32. Palmieri, A., Dissolution of Suppositories II: Acetaminophen Release from PEG Bases and Commercially Available Bases, APS Meeting, St. Louis, MO, 1981.

33. Palmieri, A. and Humberson, C., Dr. John H. Finfrock, Laramie's First Physician and Druggist, AIHP, St. Louis, MO, 1981.

34. Palmieri, A. and Hunter, R., A Student Experiment in Biopharmaceutics - Ampicillin, American Association of Colleges of Pharmacy, Boston, 1980.

35. Palmieri, A., Suppository Dissolution Testing I: Apparatus Design and Validation, APS Meeting, Washington, D.C., 1980.

36. Palmieri, A. and Ballek, J., Health Care in Pioneer Wyoming, AIHP, Washington, D.C. 1980.

37. Palmieri, A., Early Wyoming Medicine, Laramie Westerners, 1979.

38. Palmieri, A., Comparison of Urban and Rural Drug Information Centers: Utilization and Personnel, Academy of Pharmacy Practice, Anaheim, CA, 1979.

39. Palmieri, A., Frontier Medicine, Laramie County Historical Society, 1979.

40. Palmieri, A., Microencapsulation and Dissolution Parameters of Undecenovanillyamide - A Potential Coyote Deterrent, APS Meeting, 1979.

41. Palmieri, A., A Frontier Fort Hospital: Fort Laramie, Wyoming Territory, 1870-1889, AIHP Annual Meeting, Montreal, 1978.

42. Palmieri, A., Effect of Dissolved Oxygen Levels on the Oxidative Degradation of Pyrogallol, APS Meeting, Phoenix, AZ, 1977.

43. Palmieri, A., Dissolution of Prednisone Microcapsules in Conditions, Simulating The pH of the GI Tract, APhA-APS Meeting, NY, 1977.

44. Palmieri, A., A Model for Multivariate Prediction of Academic Success of Transfer Students in Pharmacy Schools, Annual Meeting of District 7, NABP-AACP, Casper, WY, 1976.

45. Harelik, J., Palmieri, A. and Scalley, R., A Model for the Development Computer Assisted Random Selection of Students for Clerkship Placement AACP Annual Meeting, Minneapolis, MN, 1976.

46. Palmieri, A. and Price, J.C., Microencapsulation of Drugs Suspended in Oil, Third International Symposium on Microencapsulation, Tokyo, 1976. ANTHONY PALMIERI III, Ph.D. Page 11 of 12

JOURNAL AND BOOK REVIEWS

Reviewed manuscripts for J. Pharm. Sci., and Am. J. Pharm. Ed., J. Pharm. Research. Reviewer for The Handbook of Nonprescription Drugs, published by APhA. Textbooks Reviewed for Am. J. Pharm. Ed.: a) "The Hydrophobic Effect" by C. Tanford, AM. J. PHARM. ED., 44:318. b) "Sustained and Controlled Release Drug Delivery Systems" by J.R. Robinson, AM. J. PHARM. ED., 43:165. c) "Microencapsulation and Related Drug Processes" by P.F. Darcy, AM. J. PHARM. ED., 48:455. d) "Validation of Aseptic Pharmaceutical Processes" by Carleton and Agalloco, AM. J. PHARM. ED. e) "Remington's Pharmaceutical Sciences", AM. J. PHARM. ED.

OTHER PUBLICATIONS

1. Palmieri, A., My heros have always been pharmacists, American Pharmacy (Leadership Forum), Vol. NS30, No. 6, p. 64, June 1990.

2. Palmieri, A., Globalization, It's a small world after all..., APRS Academy Report, Vol. 27, No. 1, April 1990.

3. Palmieri, A., Professional Status and Shortages, American Pharmacy (Leadership Forum), Vol. NS29, #10, p. 54, Oct. 1989.

4. Palmieri, A., 21st Century Drug Development: Many Questions, Few Answers, Academy Reporter, Vol. 26, #2, June 1989.

5. Palmieri, A., Analytical Pharmaceutical Chemistry (letter to the editor), AM. J. PHARM. ED., 48:92, 1984.

6. Palmieri, A., Wasting Space on Conversion Tables, AMERICAN PHARMACY, NS22, 9 p. 5 September 1982.

7. Palmieri, A., There are No Pills Anymore, (letter to the editor), HOSPITAL PHARMACY, 16:627, 1981.

8. Palmieri, A., Equivalent Drugs, Home Economics Extension Journal, University of Wyoming, March 1979.

9. Palmieri, A., The FDA - Protector or Violator of Consumer Rights, Home Economics Extension Journal, University of Wyoming, July 1977.

10. Palmieri, A., Comment on Dr. Clinical Series, (letter to the editor), DRUG INTELLIGENCE ANTHONY PALMIERI III, Ph.D. Page 12 of 12 AND CLINICAL PHARMACY, 10:656, 1976.

11. Palmieri, A., Drug Substitution, Home Economics Extension Journal, University of Wyoming, June 1976.

12. Palmieri, A., Pharmaceutical Preparations, Wyoming Drug Information Newsletter,Vol. 1, Winter 1976. Adjunct Faculty Pharmaceutics Department Page 1 of 16

Adjunct Faculty

Last updated October 22, 2007

Vikram Arya, PhD, FCP FDA Coming soon Email: [email protected]

Dr. Vikram Arya is a Senior Clinical Pharmacology Reviewer in the Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), FDA. He earned his Ph.D. in Pharmaceutics from the University of Florida, Gainesville, FL, in 2003. He has several publications in peer reviewed journals and has presented at various national and international conferences. He is a Fellow of the American College of Clinical Pharmacology (ACCP). He holds an Adjunct Clinical Professor (Special Title) appointment in the Department of Pharmacy Practice at Mercer University, Atlanta, GA. He serves as the Section Editor in the Journal of Clinical Pharmacology (JCP) and is a member of the Editorial Board of JCP and International Journal of Clinical Pharmacology and Therapeutis (IJCPT).

Jeffrey Barrett,PhD, FCP

Children's Hospital of Philadelphia Email: [email protected]

Dr. Barrett is Associate Professor of Pediatrics and Pharmacology at the Children's Hospital of Philadelphia (CHOP) and University of Pennsylvania. He is also the Director of the Laboratory for Applied PK/PD within the Clinical Pharmacology and Therapeutics Division at CHOP. Prior to joining CHOP, Dr. Barrett spent 13 years in the pharmaceutical industry most recently at Aventis Pharmaceuticals where he was Global Head of Biopharmaceutics supporting late stage development. He received his B.S in Chemical Engineering from Drexel University in 1986 and his Ph.D. in Pharmaceutics from the University of Michigan in 1990 under Dr. John G. Wagner. He has been a faculty member of the Pharmaceutical Education and Research Institute (PERI) as a lecturer for the Pharmacokinetics and Nonclinical Statistics training courses since 1992. and was a member of both the PhRMA and FDA Expert Panels on Individual and Population Bioequivalence. Dr. Barrett has co-authored over 50 manuscripts and has given 35 invited lectures on a variety of topics related to clinical drug development. He founded the Mid-Atlantic Population Approach Users Group in 1992 and is a member of the Advisory Boards of the East Coast Population Approach Group, the American Association of Pharmaceutical Scientists (AAPS) Bioequivalence and Population Pharmacokinetics Focus Groups, and the Innaphase Corporation. Dr. Barrett is a member of AAPS, ASCPT, ACCP and ASPET and was former Chair http://www.cop.ufl.edu/safezone/pat/pc/adjunct_faculty.htm 2/19/2008 Adjunct Faculty Pharmaceutics Department Page 2 of 16 of the Delaware Valley Drug Metabolism Discussion Group. He was elected to Fellow of the American College of Clinical Pharmacology in 2000 and was awarded the Tanabe Young Investigator Award in 2002. Dr. Barrett was also recently elected to the Board of Regents of ACCP and as Vice-Chair of the Clinical Sciences Section of AAPS.

Focus at Children's Hospital of Philadelphia:

Dr. Barrett's current efforts in conjunction with the mission of the Clinical Pharmacology and Therapeutics Division are focused on the investigation of sources of variation in pediatric pharmacokinetics and pharmacodynamics. Applied clinical pharmacologic investigation coupled with modeling and simulation strategies are pursued with the intention of developing rational dosing guidance in various pediatric populations for both marketed and exploratory compounds. Clinical trial simulation is to be utilized prospectively to explore design dependencies and parameter sensitivities. Dr. Barrett also directs the Laboratory for Applied PK/PD which is focused on the development of pharmacometric approaches to advance PK/PD, novel biomarker development and disease progression modeling.

Research Interests / Current Efforts

"The focus of my research is really driven by two objectives: (1) the utilization of PK/PD modeling and simulation techniques to establish links between drug exposure, actions, and therapeutic outcomes and (2) pursuit of therapeutic drug monitoring (TDM) in conjunction with modeling and simulation strategies to improve the management of pediatric drug therapy within CHOP." The list below describes ongoing efforts and research topics I am currently exploring. - Development of physiologically-based PK models to explore maternal to fetal drug transfer, - Population-based PK model development in support of ongoing/proposed study drugs (Heparin, Midazolam and Actinomycin-D), - Data warehousing and data mining approaches in bio- and medical informatics, - Development of novel biomarkers for the investigation of heparin and LMWH patient management through anticoagulant PK/PD, - Exploration of physiologic - developmental PK/PD models which predict drug exposure in various pediatric populations based on drug substance /physiochemical characteristics in conjunction within adult PK/PD behavior, - Exploration of trial design characteristics for optimal pediatric drug trials focused on safety, PK, PK/PD and/or efficacy through clinical trial simulation.

Robert Baughman, PharmD, PhD

Email: [email protected]

Dr. Baughman received his B.Sc. from Loyola University in 1974, and both Pharm.D. (1978) and Ph.D. (Pharmaceutical Chemistry, 1982) degrees from the University of California, San Francisco. He has held research positions at Lederle Laboratories, Genentech, Penederm, Cholestech, and Emisphere Technologies. He is currently the Managing Director, Corporate Strategy at Emisphere while also serving as a consultant to the pharmaceutical and venture capital industries.

Dr. Baughman's research interests include characterizing absorption mechanisms for macromolecules, http://www.cop.ufl.edu/safezone/pat/pc/adjunct_faculty.htm 2/19/2008 Adjunct Faculty Pharmaceutics Department Page 3 of 16

optimizing oral drug delivery, the disposition of therapeutic peptides and proteins, and the effect of disease states on drug pharmacokinetics. His publications include more than 130 manuscripts and abstracts in these areas, and he has authored three book chapters on the kinetics of therapeutic proteins. He co-edited the book Therapeutic Proteins: Pharmacokinetics and Pharmacodynamics (W.H. Freeman, 1992), and serves on the editorial board of the International Journal of Clinical Pharmacology and Therapeutics. He has conducted pharmacokinetic studies on over 15 recombinant products, including clinical pharmacokinetic trials with rhInsulin, rtPA, rhGH, rTNFα and rIFN-g .

Dr. Baughman is a past Chairman of the Biotechnology Section of the American Association of Pharmaceutical Scientists (AAPS), and in 1994 was elected to a three year term as the association’s Treasurer. He served on the AAPS Executive Council from 1995 – 1997. He sits on the advisory board of the American College of Clinical Pharmacology and holds an adjunct faculty appointment in Pharmaceutical Biotechnology at the University of Florida, College of Pharmacy. He is a member of AAPS, ACS, CRS, Rho Chi and Rho Pi Phi.

Robert Bell, PhD Drug and Biotechnology Development, LLC

Email:[email protected]

Drug & Biotechnology Development, LLC (D&BD) is a comprehensive consortium of experienced clinicians, pharmaceutical scientists, regulatory strategists and business development experts that provide product and business development assistance and solutions for the pharmaceutical, biotech, medical product and related industries. From project conception to product launch, D&BD provides a focused approach to the pharmaceutical and clinical development of drugs, devices and biologics for regulatory submissions. D&BD has extensive experience with all phases of product development, including pre-clinical, clinical (Phase I-IV), CMC (analysis, formulations, process, production), outsourcing, CRO oversight and regulatory interactions, document preparation, review and filings.

Marcus Brewster, PhD Senior Research Fellow Head of Dept. Drug Delivry Research Janssen Research Foundation

Email: [email protected]

Dr. Marcus E. Brewster is a Senior Research Fellow and Head of the Department of Drug Delivery Research at the Janssen Research Foundation, Beerse Belgium. He also serves on the faculty of the University of Florida, College of Pharmacy as an Adjunct Associate Professor. He received his BS degree from Mercer University in 1978 and his Ph.D. from the University of Florida in 1982 working with Prof. Nicholas Bodor. Dr.

http://www.cop.ufl.edu/safezone/pat/pc/adjunct_faculty.htm 2/19/2008 Adjunct Faculty Pharmaceutics Department Page 4 of 16

Brewster also spent two years as a Visiting Scientist at the Weizmann Institute of Science in Rehovot, Israel (1996-97). He has published 146 journal articles, written or contributed to over 20 book chapters and proceedings and holds 12 patents. He is an member of several editorial boards and a recipient of the Johnson and Johnson Excellence in Science Award. Dr. Brewster’s main research interests include the use of chemically modified cyclodextrin derivatives for pharmaceutical application, brain-targeted drug delivery through the use of chemical delivery systems and the application of molecular orbital and other computational approaches in addressing items of chemical and biological concern.

Staffan Edsbäcker, PhD Astra Zeneca

Email:[email protected]

Age 48, married, 2 children 15 and 18 yrs; Chemical engineer, M.Sci 1979; Joined Astra 1980 (Dept of Metabolism and Pharmacokinetics); Ph D 1986 (”Studies on the metabolic fate and pharmacokinetics of budesonide”); Assoc Prof., Experimental Clinical Pharmacology, Faculty of Medicine, Univ of Lund 1997- current; Section Head from 1990 - March 1999; Scientific Adviser at Experimental Medicine, AstraZeneca R&D Lund for 6 global AstraZeneca projects March 1999-June 2001; Secondment as Sr Director, Experimental Medicine, AstraZeneca Pharmaceuticals LP, Wilmington USA 2001-2003; Currently Sr Scientific Advisor for GI and respiratory projects. Preclinical experience in metabolism (tissue homogenates, isolated perfused tissues); Human pharmacology experience in traditional pharmacokinetics (exploratory and documentative); Lung, nasal and gut deposition studies using various techniques (modelling, scintigraphy, charcoal block etc); Interaction and tolerability studies; Scientific marketing activites; Regulatory issues (Experimental Medicine responsibility for 6 NDAs). Staffan has published about 30 full length original papers, 12 book chapters and reviews, and about 50 abstracts dealing with the deposition, pharmacokinetics and systemic pharmacodynamics of topical corticosteroids in healthy subjects and patients with asthma, rhinitis and inflammatory bowel diseases. Invited lecturer at several conferences. Tutor for 2 PhD students, one of whom defended his thesis in October 1998.

Ronald Evens, PharmD President of MAPS 4 Biotec, Inc

Email: [email protected]

Ron Evens is President of MAPS 4 Biotec, Inc, consulting to biotechnology segment of pharmaceutical http://www.cop.ufl.edu/safezone/pat/pc/adjunct_faculty.htm 2/19/2008 Adjunct Faculty Pharmaceutics Department Page 5 of 16

industry concerning medical affairs roles of communications, information, and clinical trials (peri-approval and post launch). Dr. Evens is clinical professor at University of Florida, College of Pharmacy. Ron serves on the Board of Directors of Cheladerm, Inc (drug company), Healthcare Distribution Management Association Healthcare Foundation and American Society of Health-Systems Pharmacists Research and Education Foundation (Vice-Chairman); and three Dean's Advisory Boards for Colleges of Pharmacy at Universities of Florida, Kentucky and Midwestern. Invited presentations exceed 150 at national and state associations or universities. Publications are over 100, including 10 book chapters and 40 journal articles. Previously (12 years, 1989-200) at Amgen, he created and was Senior Director and Head of Professional Services Department. Professional Services was responsible for medical communications/education, marketing support, phase 2 & 4 studies, field based clinical liaisons, and product information for marketed and pipeline products. Also, he created and was Senior Director and Head of PeriApproval Research at Amgen (2000-2001). Prior to Amgen, Dr. Evens was Associate Director, Clinical Research and Medical Services at Bristol-Myers Co. (1984-89); Associate Professor and Acting Chairman of Department of Pharmacy Practice at University of Tennessee Health Sciences Center, Memphis, TN (1981-84); Associate Professor & Director of Drug Information Center at University of Texas at Austin, College of Pharmacy, and University of Texas Center for Health Sciences, College of Medicine, San Antonio (1974-81).

CV

Mario Gonzalez, PhD President P'Kinetics International

Email: [email protected]

Dr. González is President of P'Kinetics International, Inc. specializing in biopharmaceutics and pharmacokinetics research. Dr. González was previously President of GloboMax Américas and prior to that was Director of Biopharmaceutics and Pharmacokinetics at Schering Research, Miami (formerly Key Pharmaceuticals, Inc). His research has concentrated on the pharmacokinetic and pharmacodynamic evaluation of extended-release oral and transdermal drug delivery systems as well as in vitro/in vivo correlations. Prior to joining the pharmaceutical industry, Dr. González was on the Pharmacy faculty at Purdue University with teaching and graduate research responsibilities in clinical pharmacokinetics. Dr. González has been active in AAPS since its inception and was Chair of the Pharmacokinetics Section in 1995. He also served on the organizing committees of the first four AAPS/FDA SUPAC Workshops and was Co-Chair of the Organizing Committee for the first Pharmaceutical Congress of the Americas held in March, 2001. Dr. Gonzalez is also a member of the Controlled-Release Society, the American College of Clinical Pharmacology, and the American Society of Health-System Pharmacists. He serves on the editorial advisory boards of the European Journal of Pharmaceutics and Biopharmaceutics and the International Journal of Clinical Pharmacology and Therapeutics.

Ricardo Gonzalez-Rothi, MD http://www.cop.ufl.edu/safezone/pat/pc/adjunct_faculty.htm 2/19/2008 Adjunct Faculty Pharmaceutics Department Page 6 of 16

Professor of Medicine and Pharmaceutics University of Florida Not Available Email: [email protected]

Dr. Gonzalez-Rothi is Professor of Medicine and Pharmaceutics at the University of Florida. Since joining the faculty in 1982, he has also been a Staff Physician at the Gainesville VA Medical Center, and since 1991 has had a joint appointment in the Department of Pharmaceutics and was granted Graduate Research Faculty Status. He is Chief of the Pulmonary and Respiratory Therapy Section at the Gainesville VA Medical Center and Acting Chief of the Division of Pulmonary and Critical Care at the University of Florida. Dr. Gonzalez-Rothi's major faculty responsibilities have centered on clinical teaching and education, where he has been recognized in the College of Medicine as the recipient of various teaching awards over the years. Most recently, he was awarded a State of Florida University-wide Teaching Incentive Performance Award, Dr. Gonzalez-Rothi has also been involved in education extramurally, as invited Program Faculty in clinical symposia, as well as in public education via radio and television. He is the recipient of a National Institutes of Health Tuberculosis Academic Award, for the promotion of tuberculosis education at the medical center, as well as to health professionals and the public throughout the State of Florida. He has been recognized by the Florida Voluntary Health Association as Medical Volunteer of the Year for his efforts in educating the citizens of Florida. He was selected as Founding Member of the University of Florida Society of Teaching Scholars. Dr. Gonzalez-Rothi is listed in Woodward and White's "The Best Doctors in America: Southeast Region". Dr. Gonzalez-Rothi's research interests have centered on interactions between inhaled particles and lung macrophage functions, for which he has identified specific smoking-associated defects, and described functional abnormalities in macrophages of patients with alveolar proteinosis. His interest in this area shifted to exploiting the phagocytic capacity of macrophages in developing targeted drug delivery to the lungs by the use of liposomal vesicles, specifically to deliver antimyeobacterials and glucocorticoids, He has sustained continuous extramural support since joining the faculty, has served on Graduate Student doctoral committees, and as peer-reviewer for scholarly journals and grant review sections. He is alveolar/co-author of 37 peer reviewed publications, two book chapters and multiple abstracts on various clinical and research topics.

Ulrike Graefe-Mody, PhD

Boehringer Ingelheim Pharma GmbH & Co.

Email: [email protected]

Dr. Graefe-Mody is working in Clinical Pharmacokinetics/Pharmacodynamics at Boehringer Ingelheim Pharma GmbH & Co. KG, Germany. Her responsibilities include the conduct of clinical pharmacokinetic/pharmacodynamic studies in the course of drug development and approval of new drug candidates in various therapeutic areas. This also includes POP PK/PD modeling and trial simulation to support drug development. Prior to joining Boehringer Ingelheim, Dr. Graefe received her Diploma in Biology in 1997 and PhD degree in Pharmaceutical Biology in 2001 from the University of Wuerzburg, Germany. Her thesis focused on the clinical pharmacokinetics and bioavailability of phenolic compounds in phytomedicines, which was carried out in cooperation with Prof. Hartmut Derendorf at the University of Florida, Gainesville, FL. In 2001, Dr. Graefe-Mody received the Carl-Wilhem-Scheele Award of the German Pharmaceutical Society for outstanding dissertations in Pharmaceutical Sciences.

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Ray Jurgens, PhD

Regional Medical Science Liaison Ligand Pharmaceuticals Email:

Dr. Jurgens received his Bachelor of Science in Pharmacy from Drake University. After working in retail pharmacy for a year and a half, heenrolled at the University of Florida and completed his PhD in the Pharmaceutical Sciences in 1973. He initially started out in academia, but after 3 years moved into the pharmaceutical industry. Over the last 25 years, he has moved through various departments, worked in several pharmaceutical companies and has had increasing areas of responsibilities. The first half of his career he developed expertise in formulations, parenterals and project management. The last 14 years, Dr. Jurgens has done clinical research in GI, CNS, female health care and most recently oncology. He has lectured in drug development and clinical in major academic institutions throughout the country. Currently, he owns several patents and has over 40 publications. He is on several scienitific advisory boards for academic institutions and companies. He is professionally affliated with Rho Chi, Kappa Psi, ACRP, ASHP, ACCP, and DIA. He is also a registered pharmacist. Dr.Jurgens currently resides near Clearwater, Florida and is a regionally based medical science liaison in the Medical Affairs department at Ligand Pharmaceuticals - a biotech firm located in San Diego, California.

Kiman Kim, MS

Email: [email protected]

Mr. Kiman Kim is a deputy director of herbal medicine management team at Korea Food and Drug Administration (KFDA). He is responsible for herbal medicine approval, pharmaceutical company inspection, and international collaboration at KFDA. He received his bachelor of pharmacy degree from Seoul National University, Republic of Korea in 1983, and got a master of pharmaceutics degree from the same university in 1985. He was a senior researcher developing drug dosage forms and drug delivery systems at the research center of Yuhan Pharmaceutical Co. in Korea (1985—1990). He was with the Seoul Metropolitan Government as a pharmaceutical inspector (1993— 1996), and has been working for KFDA since 1996. Since 1993 he has inspected hundreds of pharmaceutical companies in Korea and in the world as a pharmaceutical inspector. He researched the harmonization activities in the drug approval process between the USA, Europe and Asia with particular emphasis on biopharmaceutics and pharmacokinetics under the supervision of Dr. Hartmut Derendorf at University of Florida (2002—2004). He published a paper with Dr. Derendorf concerning the differences in the drug pharmacokinetics between East Asians and Caucasians http://www.cop.ufl.edu/safezone/pat/pc/adjunct_faculty.htm 2/19/2008 Adjunct Faculty Pharmaceutics Department Page 8 of 16 and the role of genetic polymorphisms in 2004. He is interested in building the international harmonization of herbal medicine approval and study.

Sriram Krishnaswami, PhD

Email: [email protected]

Dr. Sriram Krishnaswami is an Associate Director in Clinical Pharmacology at Pfizer Global R&D based in Ann Arbor, MI. He received his B.S. in Pharmacy in 1996 from the Birla Institute of Technology and Science, Pilani, India and Ph.D. in Pharmacokinetics/Pharmacodynamics in 2000 from the University of Florida, Gainesville. Dr. Krishnaswami is responsible for representing the clinical pharmacology function in development teams and during interactions with regulatory authorities. His current research activities include designing dose-finding strategies using modeling and simulation for new chemical entities in the inflammation/dermatology therapeutic area where treatments for diseases such as rheumatoid arthritis, psoriasis and osteoarthritis and prevention of allograft rejection are pursued. Dr. Krishnaswami has published over 30 articles, abstracts, a book chapter and presentations with focus on PK/PD modeling and pediatric pharmacology. He is chair-elect of the AAPS modeling and simulation focus group and peer reviews manuscripts for the Journal of Clinical Pharmacology.

Michael Kurowski, PhD, MD

Email: [email protected]

Dr. Michael Kurowski, became a Licensed Pharmacist in 1977 and then went on to study Pharmaceutical Chemistry and received his PhD from the Freie Universität Berlin in 1980. He continued his education, receiving his MD from Friedrich Alexander Universität, Erlangen-Nuremberg, Germany in 1986. In 1989 he was Privatdozent, Senior Lecturer for Pharmacology and Toxicology at the Friedrich Alexander Universität, Erlangen-Nuremberg, and then in 1992 became a Specialist for Clinical Pharmacolgy, Charite, Humboldt Universität, Berlin. In addition to being Co-editor of the Journal Pharmacotherapy, Dr. Kurowski has been a consultatnt to the community of practicing physicians and Ciba-Geigy, a member of the "Drugs Commision", Chairte, University Hospital, and is an Associate Professor of Pharmacology and Toxicology, Martin Luther Universität Halle Wittenberg. Dr. Kurowski has received numerous awards and fellowships for his work. Dr. Kurowksi has been involved in clinical studies and analytics of analgesic and novel antiretrovial compounds http://www.cop.ufl.edu/safezone/pat/pc/adjunct_faculty.htm 2/19/2008 Adjunct Faculty Pharmaceutics Department Page 9 of 16 since 1997 at the Private Practise Laboratory Medicine and was a Founder Therapia GmbH. He supervises not only PhD candidates but also medical students who are required to write a thesis in Germany. In addition to more than 50 publications in prestigious scientific journals he published 3 books.

Richard Lalond, PhD

Email: [email protected]

Richard is currently the Executive Director and Head of Clinical Pharmacokinetics and Pharmacodynamics at Pfizer Global Research and Development in Ann Arbor, Michigan. Prior to joining Pfizer (formerly Parke- Davis/Warner Lambert) in 1998, he was Senior Scientific Director at Phoenix International Life Sciences (now MDS) in Montreal, Canada. From 1984 to 1991, Richard was Assistant Professor then Associate Professor and Vice Chairman for Research at the University of Tennessee, Memphis. From 1980 – 1984 he worked at the University of Ottawa Health Sciences Centre in Ottawa, Canada. His research over the past 25 years has been focused on how to integrate pharmacokinetic and pharmacodynamic information to provide improved drug therapy in patients. He is a fellow of the American College of Clinical Pharmacology and the American College of Clinical Pharmacy and a member of the Editorial Board for Clinical Pharmacology and Therapeutics. Richard is a graduate of the University of Minnesota (Pharm.D.) and the University of Toronto (B.Sc. Pharmacy).

Lawrence J. Lesko, PhD

Email: [email protected]

Lawrence J. Lesko, Ph.D. is Director of the Office of Clinical Pharmacology and Biopharmaceutics (OCPB) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (1995- present). This Office is responsible for the review and evaluation of the biopharmaceutic, pharmacokinetic and pharmacodynamic data contained in IND’s and New Drug Applications (NDA’s). Dr. Lesko is also Chair of the Clinical Pharmacology Section of the Medical Policy Coordinating Committee, and Co-Chair of the Biopharmaceutics Coordinating Committee, in CDER that is responsible for developing guidances for industry. Dr. Lesko currently represents FDA on the Common Technical Document (Efficacy) Working Group http://www.cop.ufl.edu/safezone/pat/pc/adjunct_faculty.htm 2/19/2008 Adjunct Faculty Pharmaceutics Department Page 10 of 16

in the International Conference on Harmonization. Dr. Lesko was previously Associate Director of Research at the FDA where he was responsible for developing and managing the Product Quality Research Program in the Office of Generic Drugs (1992-95). Prior to joining FDA, Dr. Lesko was Vice President of PharmaKinetics Laboratories (1988-92) and Associate Professor of Pharmaceutics at the University of Maryland at Baltimore (1981-88). He also held an appointment in the Laboratory of Neuroscience, National Institute on Aging, National Institutes of Health, from 1985-1988 investigating the effects of age on the pharmacokinetics and pharmacodynamics of drug substances. He was a Laboratory Director in the Clinical Pharmacology Division of the University of Massachusetts Medical Center from 1979-1981 and was on the faculty of the Massachusetts College of Pharmacy from 1973-1979. Dr. Lesko received his B.S. and Ph.D. degrees in pharmaceutics from Temple University in Philadelphia, Pennsylvania and was board certified in Clinical Pharmacology by the American Board of Clinical Pharmacology in 1992. In 1998, Dr. Lesko was awarded the Outstanding Alumni Award from Temple University. He is a member and Fellow of American Association of Pharmaceutical Sciences and serves as Chair of the Drug Development and Regulatory Science Section of American Association of Clinical Pharmacology and Therapeutics. Dr. Lesko is a Fellow and a member of the Board of Regents of the American College of Clinical Pharmacology. He is also the FDA’s Federal Liaison to European Federation for Pharmaceutical Sciences. Dr. Lesko has authored or co- authored over 125 peer-reviewed articles in biopharmaceutics and clinical pharmacology and he is a frequent speaker at national and international meetings.

Nicola Luciani, BS Email:[email protected]

Mr. Nicola Luciani is a Registered Pharmacist with the Ontario College of Pharmacy, having received his Bachelor of Science Degree in Pharmacy from the University of Toronto in June 1994. He currently holds the position of Pharmacy Manager with Dell Pharmacy in Hamilton, Ontario, Canada and has been working for Dell since September 1994. Mr. Luciani is an accomplished Compounding Pharmacist specializing in Veterinary Medicine and Advanced Sports Medicine. Mr. Luciani also holds a Doctorate of Acupuncture from Medicina Alternativa, received in April 2000. He has additional special interests in Nutrition, Anti-Aging and Botanical Medicine. He is currently a Board Member of SportPharm Pharmaceuticals, California, USA. Mr. Luciani is a Consultant and Lead Facilitator for Medisca Network Inc. for Certificate Programs in Pharmacy specific to Pharmaceutical Compounding; accredited by and offered at the University of Florida College of Pharmacy.

Maureen A. McKenzie, PhD Email:[email protected]

Maureen A. McKenzie, Ph.D. is the Chief Executive Officer of DENALI BioTechnologies, L.LC. Dr. McKenzie

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has almost 20 years of experience in biotechnology as an entrepreneur, researcher and executive, and founded the first and only company in Alaska dedicated to pharmaceutical and nutraceutical discovery and development from boreal territories. DENALI BioTechnologies focuses on plants, microbes, and marine organisms that thrive in harsh habitats, with special emphasis on novel molecules from psychrophiles (“cold- lovers”). Dr. McKenzie was Affiliate Assistant Professor in the Department of Physiology and Pharmacology at the College of Veterinary Medicine of Iowa State University, Ames, in 1994, and was an Assistant Professor of Chemical Biology and Pharmacognosy and member of the Laboratory for Cancer Research in the College of Pharmacy at Rutgers, The State University of New Jersey, New Brunswick, from 1990-1993. From 1989-1990, she was a Research/Teaching Specialist in the Departments of Biochemistry and Environmental and Community Medicine of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, Piscataway, New Jersey. Dr. McKenzie was a Staff Fellow Scientist in the Diabetes Branch of the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, from 1987-1989. Prior to graduate school, she was a Microbiologist for the Mobil Oil Corporation, Princeton, New Jersey, from 1979-1981. Dr. McKenzie received a Diabetes Research and Education Foundation Fellowship in basic research from the Hoechst-Roussel Corporation (1990-1992), The New Jersey State Commission for Cancer Research -Ciba Geigy Corporation Award for Scientific Excellence in Cancer Research (1992), and the Epsilon Award for Teacher of the Year in the College of Pharmacy at Rutgers University (1993). She was selected by the American Chemical Society in 1993 as a Preceptor for Science Experience for the Economically Disadvantaged. In 1994, she was chosen by the Des Moines Register as an Iowa “Up and Comer” for extraordinary leadership in business. In 1995, she received the Linda K. Neuman Award for the Professions by the Quad-Cities Women’s Encouragement Board, and was honored as a “Woman of Spirit and Note” in the community. She served on the Board of Directors of the Quad-Cities Chapter of the American Red Cross in 1995. She has authored or co-authored numerous peer- reviewed articles, patents and is the editor-in-chief of the Encyclopedia of Medicinal Plants scheduled for publication in 2006. Dr. McKenzie holds a Ph.D. in Biochemistry from a joint program of Rutgers, the University of Medicine and Dentistry of New Jersey and Princeton University (1987), a M.S. in Food Science from Rutgers (1982) and a B.S. in Nutrition/Food Technology from Iowa State University (1978).

Markus Müller, MD

Email: [email protected]

Markus Müller, M.D. is Professor and Head of the Department of Clinical Pharmacology of the Medical University Vienna / Vienna General Hospital in Austria. He has received his M.D. from the University of Vienna Medical School with highest possible honours (sub auspiciis praesidentis rei publicae). He was trained in Emergency Medicine, Oncology, Endocrinology, Infectious Diseases, Chemotherapy and Angiology and is board certified for Internal Medicine, Clincal Pharmacology and Emergency Medicine. He holds the position of a Professor for Internal Medicine and Clinical Pharmacology. Dr. Müller serves as a European Expert for the European Agency for the Evaluation of Medicinal Products (EMEA) in London, UK and is a a frequent speaker at international meetings and a reviewer for several biomedical and pharmaceutical journals and scientific societies. He has published over 150 original articles in the field of clinical pharmacology and has received several awards including Tanabe Award of the American College of Clinial Pharmacology (ACCP) in acknowledgement of innovations in clinical pharmacology trials and the Billroth Award of the Austrian Board of Physicians.

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Adolf Nahrstedt, PhD

Institute of Pharmaceutical Biology and Phytochemistry Westfälische Wilhelms Universität Email:[email protected]

Education in Pharmacy (1962 – 1966) and Food Chemistry (1966-1968) at the University of Freiburg/Germany. PhD (Pharmacognosy) Freiburg, 1971; habilitation (Pharmaceutical Biology) Freiburg,1976; assoc. Professor of Pharmaceutical Biology, Techn. Univ. of Braunschweig/Germany 1977- 1986; full Professor and chair of Pharm. Biology and Phytochemistry, Univ. of Münster/Germany, 1986- 2004. Since Oct 2004 Prof. em.; Dr.h.c. of the Ovidius University, Constanta, Romania (2004). Honorary member of the Society of Medicinal Plant Research (GA; 2005). Scientific areas: Phytochemistry, physiological activity and biopharmaceutical aspects of traditionally used medicinal plants and their constituents. Biochemistry and physiology of secondary constituents of plants and insects, in particular the cyanogenic compounds; >190 papers in these fields; >160 lectures; >120 posters together with coworkers and students.Teaching experiences: Analytics of natural products and plant secondary constituents; Phytochemistry and biochemistry of nature-derived drugs; Pharmacology of crude drugs and plant derived compounds; Pharmacognosy (microscopy) of crude drug material; Morphology and anatomy of plants. Member of the Committee of Experts "Pharmaceutical Biology (Pharmacognosy)" of the German Pharmacopoeia (since 1987); Member of the “Board of Directors” of the Gesellschaft für Arzneipflanzenforschung (Society of Medicinal Plant Research, 1981-2005) and the “Board of Directors” of the Gesellschaft für Phytotherapie (Society of Phytoptherapy, 1995-2004); deputy-member of the Commission E of the Federal Institute of Medicinal Products and Medical Advices (2002-2004). Coeditor of Planta Medica 1983 - 1992; Editor in Chief of Planta Medica - Natural Products and Medicinal Plant Research" (1993 - 2004), since then Senior Editor of Planta Medica.

Emil Pop, PhD

Alchem Laboratories, Alachua FL Email: [email protected]

Research Chemist (1962-1965); Research Scientist (1965- 1978); Principal Research Scientist, Group Leader (1978- 1983) Chemical Pharmaceutical Research Institute, Cluj, Romania. Visiting Scientist, The Rugjer Boskovic Institute, Zagreb, Croatia (1971-72). Postdoctoral Research Associate, University of Florida, Gainesville, FL (1983-86). Senior Research Scientist (1986- 87); Group Leader (1987- 89); http://www.cop.ufl.edu/safezone/pat/pc/adjunct_faculty.htm 2/19/2008 Adjunct Faculty Pharmaceutics Department Page 13 of 16

Associate Director for Chemical Development (1989-1992; Director of Chemistry (1992), Pharmatec, Inc., Alachua, FL. Director of chemistry (1992-95); Senior Director of Chemistry (1995-1998), Pharmos Corporation, Alachua, FL. Founder, President and CEO, Alchem Laboratories Corporation, Alachua, FL (1996-); Awards: The "N. Teclu" award for chemistry granted by the Romanian Academy (1980), Honors, Distinctions: Fellow, American Association of Pharmaceutical Scientists, Fellow, American Institute of Chemists, Who’s Who in: Frontiers of Science and Technology; World; Science and Engineering; South and Southeast; America (Marquis). Men of Achievement, Dictionary of International Biography, The International Who’s Who of Intellectuals, American Men and Women of Science. Courtesy Professor, CDD, University of Florida; Inaugural Member of the Advisory Board, Florida Center for Heterocyclic Compounds, University of Florida.Professional Membership: ACS, AIC, AAAS, AAPS, IUPAC, New York Academy of Sciences, International Society of Quantum Biology and Pharmacology, Association de Pharmacie Galenique Industrielle. Chairman at the First World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology; International Advisory Board, International Conferences on Drug Optimization via Retrometabolism;Inaugural Member of the Florida Center for Heterocyclic Compounds Industrial Advisory Board; Guest Editor of a "hot topic" issue of Current Pharmaceutical Design; Member Editorial Advisory Board Letters in Drug Design & Delivery. Scientific Activity: 126 publications, 23 patents, 127 presentations. Expertise: organic, pharmaceutical, medicinal and theoretical chemistry. Drug design, synthesis and evaluation of novel drugs, prodrugs, chemical drug delivery systems; chemistry of synthetic cannabinoids. Basic research scale-up product and process development.

Lakshmi Putcha, PhD, FCP

NASA Johnson Space Center Email: [email protected]

Shashank Rohatagi, PhD,MBA,FCP

Sankyo Pharma Development Email: [email protected]

Dr. Shashank Rohatagi is a Senior Director in Translational Medicine and Clinical Pharmacology Department at Daiichi Sankyo Pharma Development (DSPD), Edison, NJ, since August, 2004. I am currently responsible for the pharmacokinetic and pharmacodynamic analysis (population and two-stage) of new drug candidates and line extension projects and oversee all 14C labeled pharmacokinetic studies. Previous to joining DSPD, Dr. Rohatagi was a Director, Drug Metabolism and Pharmacokinetics at Aventis

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Pharmaceuticals in Bridgewater, N.J, since 1996. He received a PhD degree in Pharmaceutics from the University of Florida, Gainesville, FL in 1995 and an MBA degree from St. Joseph's University in 2000. His main interest is in elucidating pharmaceutical principles especially pharmacokinetics and pharmacodynamics in the field of asthma, oncology, immunology, cardiovascular disease, diabetes and central nervous system (CNS). He has currently published more than 50 peer-reviewed articles, given more than 60 poster or oral presentations at various national and international meetings. He is currently a member of American Association of Pharmaceutical Scientists (AAPS), American College of Clinical Pharmacology (ACCP), American Society of Clinical Pharmacology and Therapeutics (ASCPT) and American Academy of Allergy, Asthma, and Immunology (AAAAI). He is a Fellow of American College of Clinical Pharmacology. He serves on the Editorial Board of the Journal of Clinical Pharmacology and peer review manuscripts for the International Journal of Clinical Pharmacology and Therapeutics.

Hans Schreier, PhD

Email: schreier@schreier-vonmetternich- finearts.com

Dr. Hans Schreier is a founder and CEO of MCS Micro Carrier Systems GmbH, a formulation development company based in Neuss, Germany. He received his dipl. pharm. ETH degree in 1976 and his Dr. sc. nat. degree in 1981 from the Swiss Federal Institute of Technology (ETH) Zurich, Switzerland, followed by postdoctoral training from 1981-1983 at the University of California – San Francisco (UCSF) and a Senior Scientist position at Liposome Technology, Inc., in Menlo Park, California from 1983-1986. During his academic career, he held appointments as Assistant Professor and Associate Professor of Pharmaceutics at the University of Florida College of Pharmacy (1986-1993) and Associate Professor of Medicine at Vanderbilt University School of Medicine (1993-1995). He has been a founder, Director and the Principal Scientist of Advanced Therapies, Inc., a nonviral gene delivery company (1995-1998) and is a co-founder of ARYx Therapeutics, Los Altos Hills, CA, a virtual drug discovery and pharmaceutical development company. He is the Executive Director of Liposome Research Days, Inc., a non-profit organization (since 1994) and co-organizer of the biennial international "Liposome Research Days" conference. He has published over 70 articles, reviews and book chapters and holds several patents. He is the editor of a recent book on 'Drug Targeting Technology: Physical, Chemical and Biological Methods' (Marcel Dekker, 2001). He is an Editorial Board member of the Journal of Liposome Research, and a member and elected Governor (1996-1999) of the Controlled Release Society (CRS). He maintains extensive professional links with individuals, companies, agencies and scientific organizations in the US, Europe, Japan, and Australia.

Sean Sullivan, PhD

Vical Inc. San Diego CA email: [email protected]

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Dr. Sullivan has been in the field of drug delivery for the past 13 years with emphasis being placed on increasing the effectiveness of drugs and decreasing side effects. Areas of therapeutic applications have included infectious disease (HIV, HSV and Hepatitis), arthritis and cancer. The drug delivery vehicles have included both liposomes and polymers for small molecular weight, such as doxorubicin and large molecular weight drugs, such as oligonucleotides and plasmids. For the past 6 years, his research efforts have applied this technology toward the development of non-viral gene delivery systems. Non-viral gene delivery systems consist of plasmid DNA encoding a therapeutic gene isolated from bacteria and formulated with either cationic lipids or polymers yielding transfection complexes. The cationic lipid based transfection complexes were developed for transfection of tumor endothelial cells for the purpose of inhibiting tumor angiogenesis. A combination of peptide targeting to receptors on tumor endothelial cells and control of therapeutic gene expression by proliferating endothelial cell promoters are being developed to yield selective delivery and therapeutic gene expression to the tumor vasculature. In addition, polymer based formulations are being developed for intramuscular administration. The purpose is to convert the transfected muscle cells into bioreactors for expression and secretion of therapeutic proteins into the blood stream. His present research program is focused on applying these technologies to the treatment of cancer, with emphasis being placed upon brain cancer.

Melanie Pecins-Thompson, PhD

Email: [email protected]

Dr. Thompson received her B.S. from University of Florida in 1989, and her Ph.D. in Pharmaceutical Science from the University of Florida in 1993. She held a research position at the Oregon National Primate Research Center. While at the Oregon National Primate Research Center, Dr. Thompson received a National Research Service Award which funded her postdoctoral studies. She was also a recipient of A Women in Endocrinology travel award. Her primary research interests are the effects of steroid hormones on serotonin neural function. She has also taught Endocrinology at Portland State University. Dr. Thompson is married with three children ages 3, 5 and 10.

Markus Veit, PhD

Managing Director International Drug Regulatory Services http://www.cop.ufl.edu/safezone/pat/pc/adjunct_faculty.htm 2/19/2008 Adjunct Faculty Pharmaceutics Department Page 16 of 16

i.DRAS GmbH Munich, Germany Email: [email protected]

In addition to his duties as Managing Director, Dr. Veit teaches at the University of Frankfurt School of Pharmacy, at the Humboldt University, Berlin and at the College of Pharmacy, University of Florida, where he conducts a two week course on the quality and efficacy of herbal medicinal products. Dr. Veit received his PhD from Julius Maximilians University, Würzburg Germany in 1990. In 1998 he received the Egon- Stahl-Price award from the International Society of Medicinal Plant Research. His current research interests include Bioanalytical methods for active ingredients in herbal medicinal products, Quality of herbal medicinal products, Pharmacokinetics and bioavailability of plant phenolics, Pharmacodynamics of plant phenolics, and the efficacy of herbal medicinal products. Dr. Veit has more than 50 peer reviewed publications. He is a member of the Member, German Pharmacopeia: Expert committee Pharmaceutical Chemistry, Chair, Scientific Expert Committee, German Pharmaceutical Manufacturers Research Association, Member, German Pharmaceutical Manufacturers Association, Expert committee on analytics and hygiene, Member, German Pharmaceutical Manufacturers Association, Expert committee on validation, Member, German Pharmaceutical Manufacturers Association, Expert committee on herbal medicinal products, a Member of the Society of medicinal plant research, in addition to being on the Expert committee on clinical studies.

Susan Way, PhD Not Available Email:[email protected]

Dr. Way received her BS in Chemistry and Biology from Georgetown College, Georgetown, KY in 1983. She later received her Ph.D. in Pharmaceutical Sciences from the University of Kentucky in 1992. She has worked in the pharmaceutical industry since 1992 and is experienced in both solid and non-solid dosage form development. She is currently a Senior Principal Scientist in the Pharmaceutics Department at Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT. where her responsibilities include preclinical and clincial dosage form development and preformulation. This includes discovery interfacing to assist in the selection of compounds entering development. Her research interests include solubilization of poorly water soluble compounds, promotion of oral absorption, as well as in vitro/in situ models for assessing drug transport.

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http://www.cop.ufl.edu/safezone/pat/pc/adjunct_faculty.htm 2/19/2008 Pharmaceutics

College of Pharmacy

Graduate Faculty 2007-2008 Chair: H. Derendorf. Graduate Coordinator: J. Hughes. Graduate Research Professor: N. Bodor. Distinguished Professor: H. Derendorf. Professors: L. Hendeles; G. Hochhaus; J. Hughes; J. Johnson; M. A. Schwartz. Associate Professors: R. Frye; S. Song; Assistant Professor: A. Beitelshees; V. Butterweck; I. Zineh. Clinical Associate Professor: W.C. Mobley; Clinical Assistant Professor: A. Palmieri. Research Assistant Professor: Rhonda Cooper-DeHoff; Taimour Langaee.

The Department of Pharmaceutics offers the Doctor of Philosophy in pharmaceutical sciences. Pharmaceutics is the scientific endeavor concerned with the design, formulation, evaluation, and use of drug delivery systems. A foundation in physical chemistry, chemistry, mathematics, and in the life sciences, is necessary. Its domain extends from studies of the physiochemical properties of drugs and related molecules to investigations of the mechanisms of physiological processes affecting drug delivery and therapeutic effectiveness. The Department's general focus involves studying the design and evaluation of traditional and novel dosage forms for delivering drug molecules and macromolecules. The design involves physical chemical studies and development of analytical techniques involving spectroscopy and chromatography. Evaluation includes development of sensitive analytical techniques for the drug in biological fluids and subsequent biopharmaceutical and clinical pharmacokinetic studies.

PHA 5121: Advanced Clinical Pharmacokinetics (2) An advanced course on pharmacokinetics and pharmacodynamics of the time course of drugs in the body. Pharmacokinetic aspects include absorption, distribution metabolism, and elimination. Pharmacodynamic aspects include quantitative relationships between drug concentration and wanted or undesired effects. Spring term.

PHA 5172: Biotechnology and Pharmacy Practice (3) Principles of recombinant DNA technology needed to interact and communicate as a pharmaceutical scientist in biotechnology. Recombinant peptide and protein drugs, including protein purification, stability, quality control, and dosage form design. Fall term. PHA 6115: Equilibria, Complexations, and Interactions of Drugs (3) Models for drug interactions in solution. Physical chemistry characteristics of drugs and their complexes in pharmaceutical systems.

PHA 6116: Drug Stability (3) Drug degradation mechanisms, shelf-life determination, and drug product stabilization from industrial and pharmacy practice perspectives. Fall term even years.

PHA 6118: Molecular Diversity (2) Combinatorial and high throughput methods to generate leads for drug discovery and accelerated drug development.

PHA 6125: Pharmacokinetics and Biopharmaceutics (3) Compartmental analysis with computers. Spring term, even years.

PHA 6170C: Pharmaceutical Product Formulation (3) Rationale and design of pharmaceutical dosage forms. Fall term, odd years.

PHA 6183: Pharmaceutical Gene Delivery (3) This course is designed for graduate students, whose research is related to gene delivery. The course include three sections: 1) lectures of vector design and construction including review of related molecular biology and cell biology; 2) lectures of gene delivery systems (both viral and nonviral vectors) and their applications; 3) recent progress of gene therapy for human diseases. In this section, each student selects one topic and gives a presentation. Odd years

PHA 6185: Pharmaceutical Drug Development (3) Drug development from discovery to post-market surveillance. Good manufacturing process (GMP), good clinical practice (GCP), and good laboratory practice (GLP); intellectual property, regulatory agencies, generic approvals and case studies.

PHA 6416: Pharmaceutical Analysis I (3) Theory and applications of relevant analytical techniques for analysis of drugs in biological samples. Spring term, odd years.

PHA 6427: Pharmacogenetics of Drug Metabolism and Transport (2): Examination of factors that affect drug disposition and response including genetics, as well as, additional factors such as environment, diet, age, and concurrent drug therapy and health status. Students will acquire an understanding of pharmacogenetics/pharmacogenomics in the context of variability in drug disposition and the application of pharmacogenetics to drug development and drug treatment. Offered fall semester in even- numbered years.

PHA 6440: Seminar in Drug Discovery (1; max: 8) Weekly presentations of research topics related to drug design and discovery. S/U option.

PHA 6449: Pharmacogenomics (2): Pharmacogenetics and pharmacogenomics research design, including utilization of key knowledge from the human genome and HapMap projects, candidate gene, versus genome-wide approaches, other considerations in design of human pharmacogenomics investigations, and approaches to defining functional effects of pharmacogenetic candidates. Students with acquire knowledge and skills to undertake pharmacogenomics research. Offered fall semester in odd-numbered years

PHA 6938: Seminar Series PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 1 of 23

PhD in Pharmaceutical Sciences

Last modified February 25, 2008

The current Ph.D. in Pharmaceutical Sciences with specialization in Pharmacy graduate program is offered by the Department of Pharmaceutics. The departmental faculty has decided to use 'track' method for accommodating the diversity of the Deparment's graduate population, its multi- and interdisciplinarity.

The focus of the Department of Pharmaceutics, which houses the Center for Drug Discovery, differs sufficiently from that of other departments as to justify a specialization. The uniqueness of the department is evident in present research activities which encompass basic, applied and clinical investigations in the areas of Biopharmaceutics and Pharmacokinetics, Pharmaceutical Biotechnology, Pharmaceutical Analysis, Drug Delivery, and Drug Discovery. Specifically, Biopharmaceutics and Pharmacokinetics, encompasses the absorption, distribution, metabolism and excretion of drugs in animals and humans, and the relationship between drug concentration and effect; Pharmaceutical Biotechnology includes molecular biology, immunology, and aspects of the delivery of peptide and protein drugs; Pharmaceutical Analysis involves the application of spectroscopy, chromatography, extraction, electrophoresis, immunoassays, and radioisotope assays to drug determination; Drug Delivery includes physical, biological and chemical approaches to drug delivery, formulation and evaluation of dosage forms; and Drug Discovery is associated with receptor-oriented/retrometabolic drug design, computer assisted drug design, chemical/physical approaches to controlled drug delivery, pharmacokinetic-pharmacodynamic correlation approach to improved therapeutic index.

z Objectives of the Ph.D. Program z Faculty z Adjunct Faculty z Governance z Recruitment of Students z Admission Procedures z Financial Assistance z Selection of Discipline for Degree and Major Professor z Supervisory Committee z Curriculum z Qualifying Examination z Final Examination z Specific Requirements for the Master of Science in Pharmacy Degree

The objectives of the Ph.D. program in the Department of Pharmaceutics are:

z To provide a foundation in the pharmaceutical sciences in general, as well as in the specific tracks identified, with emphasis on pharmacokinetics, biopharmaceutics, pharmaceutical analysis, pharmaceutical technology/drug delivery, pharmacodynamics, pharmaceutical biotechnology, and drug design and discovery. z To educate individuals capable of conducting independent research and with in-depth specialized knowledge in one of the above areas and to provide a solid educational, technical and experiential foundation for students in the industrial, academic, governmental or other arenas. z To provide an environment that nurtures and stimulates the research interests and the intellectual http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 2 of 23 advancement of students and faculty, including a forum for scientific and professional discussion.

Faculty

Nicholas Bodor, PhD, Graduate Research Professor, Director, Center for Drug Discovery

Research Interests: Design of drugs with improved therapeutic index, based on retrometabolic concepts, design of new chemical and physical delivery systems, computer assisted drug design, drug transport and metabolism, and theoretical mechanistic organic chemistry. Ongoing research is performed in all of the areas mentioned.

Veronika Butterweck, PhD, Assistant Professor,

Research Interests: Research program focuses on the study of herbal medicines with CNS activity. Specific areas of focus include the investigation of plants with antidepressant or anxiolytic activity, phytomedicines for the treatment of restlessness and sleep disturbances and herbal remedies for the prevention of alcohol dependency.

Hartmut Derendorf, PhD, Professor of Pharmaceutics

Research Interests: Correlation of pharmacokinetic and pharmacodynamic behavior of drugs (corticosteroids, analgesics, antibiotics); analysis of drugs and metabolites in biological fluids by HPLC- pharmacodynamic evaluations by pharmaco-electroencephalography (EEG); pharmacokinetics in sickle cell patients.

Reginald Frye, PharmD, PhD, Associate Professor

Research Interests Dr. Frye's clinical research program has focused on the identification and characterization of factors that contribute to interindividual variability in drug response. Current focus is on genetic and non genetic (e.g., age, disease) factors that cause variability in drug metabolism, which can be assessed with in vivo probes that can measure the activity of specific drug- metabolizing enzymes in individual subjects. Dr. Frye has received funding for his research from the Pharmaceutical Industry and the National Institutes of Health.

Leslie Hendeles, PharmD, Professor

Research Interests: Leslie Hendeles, PharmD, is Professor of Pharmacy and Pediatrics in the Colleges of Pharmacy and Medicine, at the University of Florida. He received his PharmD degree from the University of Southern California in 1969. His current interests are improving adherence to asthma medications and delivery of inhaled drugs to young children. Dr. Hendeles has authored numerous articles and book chapters on the clinical pharmacology of drugs for asthma and allergic rhinitis. He has received national recognition-for outstanding contribution to the literature from both the American Society of Hospital Pharmacists and the American College of Clinical Pharmacists as well as the American Pharmaceutical Association's award for Lifetime Research Achievement. He is a consultant to the FDA's Pulmonary Division and serves on the Coordinating Committee of NIH's National Asthma Program . The University of Southern California http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 3 of 23 selected him as their 1993 Outstanding Alumnus, and students in the Working Professional Pharm.D. program at UF selected him as their Outstanding Faculty of the Year for 2002. Dr. Hendeles provides advice on drug therapy to physicians and teaches in the Pediatric Pulmonary Clinic at UF.

Guenther Hochhaus, PhD, Professor of Pharmaceutics,

Research Interests: Dr. Hochhaus' research includes the development of novel analytical techniques for the measurement of drugs in biological fluids by chromatographic and immunological techniques- the metabolism, pharmacokinetic and pharmacodynamic properties of opioid peptides, pharmacokinetic/dynamic (PK/PD) behavior of anti-asthmatic drugs and their relevance for the formulation of targeted pulmonary delivery systems.

Jeffrey Hughes, PhD, Professor of Pharmaceutics,

Research Interests: Dr. Hughes' long term goals are to elucidate the physicochemical parameters of antisense oligonucleotides and other macromolecules which influence their cellular permeability and disposition. After a basic understanding is achieved he intends to use these principles to develop better delivery systems for oligonucleotides and other biotechnology derived products.

Julie Johnson, PharmD, FCCP, BCPS, Professor and Chair, Dept. Pharmacy Practice

Research Interests: Dr. Johnson's research focus is cardiovascular drug pharmacogenomics, disease-gene associations that may be relevant to pharmacogenomics, and the influence of race/ethnicity on drug response and pharmacogenomics. She currently has studies ongoing in the areas of hypertension, heart failure, ischemic heart disease and obesity, with a primary focus on proteins that are drug targets and the impact of their genetic polymorphisms on drug response and disease. Her research has been continuously funded by the National Institutes of Health and/or the American Heart Association since 1990.

Taimour Y. Langaee, MSPH, PhD, Research Assistant Professor, Dept. Pharmacy Practice

Taimour Y. Langaee, MSPH, Ph.D., is Research Assistant Professor in the Department of Pharmacy Practice at the University of Florida (UF) College of Pharmacy and Director of the UF Center for Pharmacogenomics Genotyping Core Laboratory. Before joining the UF faculty in 2002, he completed three years of post-doctoral fellowship in Immunology and Molecular Biology, and Microbiology and Molecular Genetics working on developing HIV vaccine at the College of Medicine University of Montreal and High Density DNA chips for Pseudomonas aeruginosa at the College of Medicine University of Florida.

Dr. Langaee's research interests are focused on pharmacogenetics (genetic-based variability in drug response) in cardiovascular and auto-immune diseases and developing microarray-based technology methods to facilitate disease diagnosis, genotyping of patients and discovering disease-gene associations.

Cary Mobley, PhD, Clinical Associate Professor

Research Interests: Use of liposomes for pulmonary delivery and as oral vaccine adjuvants. Conceptual integration of the pharmacy curriculum.

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 4 of 23 Anthony Palmieri III, PhD,RPh, Clinical Associate Professor Dr. Palmieri's major responsibilities include licensing of pharmaceutical and life sciences intellectual property. Palmieri holds a BS and MS in pharmacy from the University of Rhode Island and the Ph.D. from the University of Georgia. Prior to his present position he was at The Upjohn Company for sixteen years. . Palmieri was Professor of Pharmacy at the University of Wyoming. He is the author of numerous scientific, academic, and historical papers. He served as the Laboratory Editor for the third edition of the Handbook of Pharmaceutical Excipients. Palmieri is very active on the national level of Kappa Psi Pharmaceutical Fraternity and is currently the national vice-president. Palmieri is past chairman of APRS. Currently he is Chair-elect of the Basic Sciences section. He is a fellow of APhA-APRS and has authored chapters on dissolution, microencapsulation, pharmaceutical excipients and history of pharmacy.

Michael A. Schwartz, PhD, Professor of Pharmaceutics, Dean Emeritus

Dr. Schwartz will lecture in graduate courses related to dosage forms and drug stability in the program.

Sihong Song, PhD, Associate Professor

Research Interests: Dr. Song's interests are in 1)improvement of safety and efficiency of rAAV vector by understanding molecular mechanisms of persistence and integration of the AAV genome in mammalian cells and 2) the use of recombinant Adeno-Associated Virus (rAAV) vectors mediated gene transfer to develop gene therapy approaches for common diseases such as diabetes and arthritis.

Amber Beitelshees, PharmD, Assistant Professor

Amber Beitelshees, PharmD, MPH, is Assistant Professor in the Department of Pharmacy Practice at the University of Florida College of Pharmacy. She received her Pharm.D. degree from the University of Florida in 2001. She then completed a residency in Pharmacy Practice at the University of Illinois Medical Center at Chicago. In 2005, Dr. Beitelshees completed her postdoctoral fellowship in Cardiovascular Pharmacogenomics and Master of Public Health degree in epidemiology. After serving on faculty at Washington University in St. Louis School of Medicine she returned to the University of Florida in 2007. Her research is aimed at investigating the metabolic effects of cardiovascular medications and the pharmacogenomics of diabetic cardiovascular disease.

Rhonda Cooper-DeHoff, PharmD, Research Assistant Professor

Dr. Cooper-DeHoff joined the Division of Cardiovascular Medicine Faculty in September 1999, having previously held a research pharmacist position at Shands UF. My primary responsibilities have been focused in research, both clinically and administratively. In clinical research , she is currently PI on an NIH (NHLBI) funded K23 5 year grant entitled Metabolic Effects of Antihypertensive Drugs. Additionally, Dr. Cooper-DeHoff is a co-investigator on 2 NIH grants focused in the area of pharmacogenetics and hypertension. In 2001 she received a New Investigator Award from the American Heart Association. In research administration , she serves as the Associate Director for the Clinical Trials Section of the Division of Cardiovascular Medicine. In this capacity she oversees the development, facilitation, and management of investigator initiated and extramurally funded clinical research.

Leslie Hendeles, PharmD, Professor

Leslie Hendeles, PharmD, is Professor of Pharmacy and Pediatrics in the Colleges of Pharmacy and Medicine, at the University of Florida. He received his PharmD degree from the University of Southern California in 1969. His current interests are improving adherence to asthma medications and delivery of

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 5 of 23 inhaled drugs to young children. Dr. Hendeles has authored numerous articles and book chapters on the clinical pharmacology of drugs for asthma and allergic rhinitis. He has received national recognition-for outstanding contribution to the literature from both the American Society of Hospital Pharmacists and the American College of Clinical Pharmacists as well as the American Pharmaceutical Association's award for Lifetime Research Achievement. He is a consultant to the FDA's Pulmonary Division and serves on the Coordinating Committee of NIH's National Asthma Program . The University of Southern California selected him as their 1993 Outstanding Alumnus, and students in the Working Professional Pharm.D. program at UF selected him as their Outstanding Faculty of the Year for 2002. Dr. Hendeles provides advice on drug therapy to physicians and teaches in the Pediatric Pulmonary Clinic at UF.

Julie Johnson, PharmD, FCCP, BCPS, Professor and Chair, Dept. Pharmacy Practice

Julie A. Johnson, Pharm.D., FCCP, BCPS is Professor and Chair of the the Departments of Pharmacy Practice, Professor of Pharmaceutics and Professor of Medicine (Cardiovascular Medicine) at the University of Florida Colleges of Pharmacy and Medicine, and Director, University of Florida Center for Pharmacogenomics. She joined the faculty at the University of Florida in May 1998. Prior to her appointment on the UF faculty, she spent 9 years on the University of Tennessee College of Pharmacy faculty. She received her B.S. in Pharmacy from the Ohio State University and her Pharm.D. from the University of Texas at Austin and the University of Texas Health Science Center at San Antonio. Following her Pharm.D., she completed a post-doctoral fellowship in cardiovascular pharmacology/ pharmacokinetics at the Ohio State University. Dr. Johnson's research focus is cardiovascular drug pharmacogenomics, disease-gene associations that may be relevant to pharmacogenomics, and the influence of race/ethnicity on drug response and pharmacogenomics. She currently has studies ongoing in the areas of hypertension, heart failure, ischemic heart disease and obesity, with a primary focus on proteins that are drug targets and the impact of their genetic polymorphisms on drug response and disease. Her research has been continuously funded by the National Institutes of Health and/or the American Heart Association since 1990. Dr. Johnson is presently serving a four year term on the Nonprescription Drugs Advisory Committee of the Food and Drug Administration. She is also serving a five year term on the Pediatric Heart Disease Clinical Research Network Protocol Review Committee for the National Heart Lung and Blood Institute at NIH. She is on the editorial boards of the journals Pharmacogenetics and Pharmacotherapy and serves as manuscript reviewer for numerous other scientific journals. Dr. Johnson's awards include the University of Tennessee Excellence in Teaching Award from the Student Government Association (1996), induction as Fellow of the American College of Clinical Pharmacy (1996), the Ohio State University Alumni Association William Oxley Thompson Award for early career achievement (1997), the Outstanding Faculty Award from the University of Florida Working Professional Pharm.D. Program (2001), the Philip C. and Ethel E. Ashby Lecturer at the University of Oklahoma (2003), the Albert Ebert 31st Annual Lecturer at University of Illinois (2003) and the Leon I Goldberg Young Investigator Award from the American Society for Clinical Pharmacology and Therapeutics (2004).

Issam Zineh, PharmD, Assistant Professor

Research Interests: Issam Zineh, Pharm.D., is Assistant Professor in the Department of Pharmacy Practice at the University of Florida College of Pharmacy. Dr. Zineh received his Pharm.D. from Northeastern University (Boston) in 2000. He then went on to Duke University Medical Center where he completed his residency in Pharmacy Practice. Dr. Zineh came to the University of Florida as a post-doctoral fellow in cardiovascular pharmacogenomics in August 2001 and completed his training in December 2003. His research has focused on how polymorphisms in the 1-adrenergic receptor and type-A natriuretic peptide receptor genes contribute to variability in response to various pharmacological agents. Currently, his research focuses on the immunomodulatory effects of cardiovascular and endocrine drugs commonly used in clinical practice. Dr. Zineh has received numerous awards for both his research and clinical

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 6 of 23 service including the American Society for Clinical Pharmacology and Therapeutics Presidential Trainee Award (2003), the American He

Adjunct Faculty

Adjunct faculty will be selected by the faculty of the department and the center based on the suggestion of individual faculty member(s) and a departmental ballot. The role of adjunct faculty is to give guest lectures in graduate courses offered by the department and the center upon mutual agreement between the course coordinator and the adjunct faculty, and to advise students in graduate research (The adjunct faculty, the student, and the chair of the supervisory committee should decide about the level of involvement by the adjunct faculty). Participation in supervisory committees by an adjunct faculty will be governed by the guidelines given in the current Graduate Catalog of the University of Florida.

Richard H. Hammer, PhD, Professor Emeritus

Research Interests: Design, synthesis, and pharmacological testing of novel soft anticholinergic analogs of atropine and scopolamine as non-toxic short-acting mydriatics, antiperspirants, and cardiovascular agents.

Vikram Arya, PhD, FCP

Dr. Vikram Arya is a Senior Clinical Pharmacology Reviewer in the Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), FDA. He earned his Ph.D. in Pharmaceutics from the University of Florida, Gainesville, FL, in 2003. He has several publications in peer reviewed journals and has presented at various national and international conferences. He is a Fellow of the American College of Clinical Pharmacology (ACCP). He holds an Adjunct Clinical Professor (Special Title) appointment in the Department of Pharmacy Practice at Mercer University, Atlanta, GA. He serves as the Section Editor in the Journal of Clinical Pharmacology (JCP) and is a member of the Editorial Board of JCP and International Journal of Clinical Pharmacology and Therapeutis (IJCPT).

Jeffrey Barrett, PhD, FCP Dr. Barrett is Global Head of Biopharmaceutics at Aventis Pharmaceuticals. He received his B.S. in Chemical Engineering from Drexel University in 1986 and his Ph.D. in Pharmaceutics from the University of Michigan in 1990 under Dr. John G. Wagner. From 1990 to 1994 he was a Senior Research Pharmacokineticist at Merck Research Laboratories and from 1994 to 1997 he was the Director of Pharmacokinetics and Computer Resources at Somerset Pharmaceuticals. He was most recently at DuPont Pharmaceuticals where he was Director of Clinical Pharmacokinetics. Dr. Barrett has an adjunct appointment at the University of Florida (Pharmaceutics Department, College of Pharmacy). He has been a faculty member of the Pharmaceutical Education and Research Institute (PERI) as a lecturer for the Pharmacokinetics and Nonclinical Statistics training courses since 1992. Dr. Barrett has co-authored over 40 manuscripts. He founded the Mid-Atlantic Population Approach Users Group in 1992 and is a member of the Advisory Boards of the East Coast Population Approach Group, the AAPS Bioequivalence Focus Group, and the Innaphase Corporation. He was the co-developer of the NM-Win program (a windows-based front-end for NONMEM). Dr. Barrett is a member of AAPS, ASCPT, ACCP and ASPET and was former Chair of the Delaware Valley Drug Metabolism Discussion Group. He is a Fellow of the American College of Clinical Pharmacology. His research interests include: pharmacokinetics and pharmacodynamics, surrogate marker validation, computer applications for nonlinear mixed effect modeling, and bioequivalence. He is a current member of both the PhRMA and FDA Expert Panels on Individual and Population Bioequivalence.

Robert A. Baughman, PhD, Vice President and Director of Research & Development Emisphere Technologies, Inc.

Research Interests: Characterizing absorption mechanism for macromolecules, optimizing oral drug delivery, the disposition

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 7 of 23 of therapeutic peptides and proteins, and the effect of disease states on drug pharmacokinetics. Dr. Baughman has conducted pharmacokinetic studies on over 15 recombinant products, including clinical pharmacokinetic trials with tPA, rhGH, TNF and rlFN-b.

Robert Bell, PhD, Vice President of New and Proprietary Drug Development Barr Laboratories

Drug & Biotechnology Development, LLC (D&BD) is a comprehensive consortium of experienced clinicians, pharmaceutical scientists, regulatory strategists and business development experts that provide product and business development assistance and solutions for the pharmaceutical, biotech, medical product and related industries. From project conception to product launch, D&BD provides a focused approach to the pharmaceutical and clinical development of drugs, devices and biologics for regulatory submissions. D&BD has extensive experience with all phases of product development, including pre-clinical, clinical (Phase I-IV), CMC (analysis, formulations, process, production), outsourcing, CRO oversight and regulatory interactions, document preparation, review and filings.

Marcus E. Brewster, PhD, Director of Drug Delivery Janssen Pharmaceutica, Belgium

Research Interests: Dr. Brewster has three main research interests including (1) The use of cyclodextrins and chemically modified cyclodextrins as solubilizing and stabilizing pharmaceutical excipients. These approaches have been applied to improving parenteral dosing forms. (2) The use of quantum mechanical (molecular orbital) approaches to examine problems of biological and chemical importance. Applications include evaluating enzymatic pathways and drug stabilities. (3) Organ targeting and especially brain targeting of drugs using redox and other technologies.

Staffan Edsbäcker, PhD, Astra Zeneca

Research Interests: Age 48, married, 2 children 15 and 18 yrs; Chemical engineer, M.Sci 1979; Joined Astra 1980 (Dept of Metabolism and Pharmacokinetics); Ph D 1986 (”Studies on the metabolic fate and pharmacokinetics of budesonide”); Assoc Prof., Experimental Clinical Pharmacology, Faculty of Medicine, Univ of Lund 1997- current; Section Head from 1990 - March 1999; Scientific Adviser at Experimental Medicine, AstraZeneca R&D Lund for 6 global AstraZeneca projects March 1999-June 2001; Secondment as Sr Director, Experimental Medicine, AstraZeneca Pharmaceuticals LP, Wilmington USA 2001-2003; Currently Sr Scientific Advisor for GI and respiratory projects. Preclinical experience in metabolism (tissue homogenates, isolated perfused tissues); Human pharmacology experience in traditional pharmacokinetics (exploratory and documentative); Lung, nasal and gut deposition studies using various techniques (modelling, scintigraphy, charcoal block etc); Interaction and tolerability studies; Scientific marketing activites; Regulatory issues (Experimental Medicine responsibility for 6 NDAs). Staffan has published about 30 full length original papers, 12 book chapters and reviews, and about 50 abstracts dealing with the deposition, pharmacokinetics and systemic pharmacodynamics of topical corticosteroids in healthy subjects and patients with asthma, rhinitis and inflammatory bowel diseases. Invited lecturer at several conferences. Tutor for 2 PhD students, one of whom defended his thesis in October 1998.

Ronald Evens, PharmD, MAPS 4 Biotec Inc.

Research Interests: Ron Evens is President of MAPS 4 Biotec, Inc, consulting to biotechnology segment of pharmaceutical industry concerning medical affairs roles of communications, information, and clinical trials (peri-approval and post launch). Dr. Evens is clinical professor at University of Florida, College of Pharmacy. Ron serves on the Board of Directors of Cheladerm, Inc (drug company), Healthcare Distribution Management Association Healthcare Foundation and American Society of Health-Systems Pharmacists Research and Education Foundation (Vice-Chairman); and three Dean's Advisory Boards for Colleges of Pharmacy at Universities of Florida, Kentucky and Midwestern. Invited presentations exceed 150 at

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 8 of 23 national and state associations or universities. Publications are over 100, including 10 book chapters and 40 journal articles. Previously (12 years, 1989-200) at Amgen, he created and was Senior Director and Head of Professional Services Department. Professional Services was responsible for medical communications/education, marketing support, phase 2 & 4 studies, field based clinical liaisons, and product information for marketed and pipeline products. Also, he created and was Senior Director and Head of PeriApproval Research at Amgen (2000-2001). Prior to Amgen, Dr. Evens was Associate Director, Clinical Research and Medical Services at Bristol-Myers Co. (1984-89); Associate Professor and Acting Chairman of Department of Pharmacy Practice at University of Tennessee Health Sciences Center, Memphis, TN (1981-84); Associate Professor & Director of Drug Information Center at University of Texas at Austin, College of Pharmacy, and University of Texas Center for Health Sciences, College of Medicine, San Antonio (1974-81).

Mario Gonzalez, PhD, President P'Kinetics International

Research Interests: Dr. González is President of P'Kinetics International, Inc. specializing in biopharmaceutics and pharmacokinetics research. Dr. González was previously President of GloboMax Américas and prior to that was Director of Biopharmaceutics and Pharmacokinetics at Schering Research, Miami (formerly Key Pharmaceuticals, Inc). His research has concentrated on the pharmacokinetic and pharmacodynamic evaluation of extended-release oral and transdermal drug delivery systems as well as in vitro/in vivo correlations. Prior to joining the pharmaceutical industry, Dr. González was on the Pharmacy faculty at Purdue University with teaching and graduate research responsibilities in clinical pharmacokinetics. Dr. González has been active in AAPS since its inception and was Chair of the Pharmacokinetics Section in 1995. He also served on the organizing committees of the first four AAPS/FDA SUPAC Workshops and was Co-Chair of the Organizing Committee for the first Pharmaceutical Congress of the Americas held in March, 2001. Dr. Gonzalez is also a member of the Controlled-Release Society, the American College of Clinical Pharmacology, and the American Society of Health-System Pharmacists. He serves on the editorial advisory boards of the European Journal of Pharmaceutics and Biopharmaceutics and the International Journal of Clinical Pharmacology and Therapeutics.

Ricardo Gonzalez-Rothi, MD, Associate Professor of Medicine, Pulmonary Division

Research Interests: Dr. Gonzalez-Rothi is board certified in Internal Medicine with a Pulmonary Medicine subspecialty. His research interests center around targeted drug delivery to the lung via the aerosol route, specifically delivery of anti-mycobacterials and corticosteroids to pulmonary alveolar macrophages. He is presently involved in a multidisciplinary project to design liposome formulations of various corticosteroids in order to modulate lung macrophage functions. Besides in vitro studies on macrophage cell lines, which include receptor binding assays and a variety of immune macrophage functions, various pharmacokinetic aspects of intrapulmonary delivery of liposomal corticosteroid formulations will be studied in vivo. Dr. Gonzalez-Rothi is on the NASA Space Shuttle Medical Support Team.

Ulrike Grafe-Mody, PhD, Boehringer Ingelheim Pharma GmbH & Co.

Research Interests: Dr. Graefe-Mody is working in Clinical Pharmacokinetics/Pharmacodynamics at Boehringer Ingelheim Pharma GmbH & Co. KG, Germany. Her responsibilities include the conduct of clinical pharmacokinetic/pharmacodynamic studies in the course of drug development and approval of new drug candidates in various therapeutic areas. This also includes POP PK/PD modeling and trial simulation to support drug development. Prior to joining Boehringer Ingelheim, Dr. Graefe received her Diploma in Biology in 1997 and PhD degree in Pharmaceutical Biology in 2001 from the University of Wuerzburg, Germany. Her thesis focused on the clinical pharmacokinetics and bioavailability of phenolic compounds

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 9 of 23 in phytomedicines, which was carried out in cooperation with Prof. Hartmut Derendorf at the University of Florida, Gainesville, FL. In 2001, Dr. Graefe-Mody received the Carl-Wilhem-Scheele Award of the German Pharmaceutical Society for outstanding dissertations in Pharmaceutical Sciences.

Ray Jurgens, PhD

Dr. Jurgens received his Bachelor of Science in Pharmacy from Drake University. After working in retail pharmacy for a year and a half, heenrolled at the University of Florida and completed his PhD in the Pharmaceutical Sciences in 1973. He initially started out in academia, butafter 3 years moved into the pharmaceutical industry. Over the last 25 years, he has moved through various departments, worked in several pharmaceutical companies and has had increasing areas of responsibilities. The first half of his career he developed expertise in formulations, parenterals and project management. The last 14 years, Dr. Jurgens has done clinical research in GI, CNS, female health care and most recently oncology. He has lectured in drug development and clinical in major academic institutions throughout the country. Currently, he owns several patents and has over 40 publications. He is on several scienitific advisory boards for academic institutions and companies. He is professionally affliated with Rho Chi, Kappa Psi, ACRP, ASHP, ACCP, and DIA. He is also a registered pharmacist. Dr.Jurgens currently resides near Clearwater, Florida and is Manager, Scientific Affairs for Berlex Laboratories, a USA Division of Schering AG.

Kiman Kim, MS

Research Interests:

Mr. Kiman Kim is a deputy director of herbal medicine management team at Korea Food and Drug Administration (KFDA). He is responsible for herbal medicine approval, pharmaceutical company inspection, and international collaboration at KFDA. He received his bachelor of pharmacy degree from Seoul National University, Republic of Korea in 1983, and got a master of pharmaceutics degree from the same university in 1985. He was a senior researcher developing drug dosage forms and drug delivery systems at the research center of Yuhan Pharmaceutical Co. in Korea (1985—1990). He was with the Seoul Metropolitan Government as a pharmaceutical inspector (1993— 1996), and has been working for KFDA since 1996. Since 1993 he has inspected hundreds of pharmaceutical companies in Korea and in the world as a pharmaceutical inspector. He researched the harmonization activities in the drug approval process between the USA, Europe and Asia with particular emphasis on biopharmaceutics and pharmacokinetics under the supervision of Dr. Hartmut Derendorf at University of Florida (2002— 2004). He published a paper with Dr. Derendorf concerning the differences in the drug pharmacokinetics between East Asians and Caucasians and the role of genetic polymorphisms in 2004. He is interested in building the international harmonization of herbal medicine approval and study.

Sriram Krishnaswami, PhD

Dr. Sriram Krishnaswami is an Associate Director in Clinical Pharmacology at Pfizer Global R&D based in Ann Arbor, MI. He received his B.S. in Pharmacy in 1996 from the Birla Institute of Technology and Science, Pilani, India and Ph.D. in Pharmacokinetics/Pharmacodynamics in 2000 from the University of Florida, Gainesville. Dr. Krishnaswami is responsible for representing the clinical pharmacology function in development teams and during interactions with regulatory authorities. His current research activities include designing dose-finding strategies using modeling and simulation for new chemical entities in the inflammation/dermatology therapeutic area where treatments for diseases such as rheumatoid arthritis, psoriasis and osteoarthritis and prevention of allograft rejection are pursued. Dr. Krishnaswami has published over 30 articles, abstracts, a book chapter and presentations with focus on PK/PD modeling and pediatric pharmacology. He is chair-elect of the AAPS modeling and simulation focus group and peer reviews manuscripts for the Journal of Clinical Pharmacology.

Michael Kurowski, PhD,MD

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 10 of 23 Dr. Michael Kurowski, became a Licensed Pharmacist in 1977 and then went on to study Pharmaceutical Chemistry and received his PhD from the Freie Universität Berlin in 1980. He continued his education, receiving his MD from Friedrich Alexander Universität, Erlangen-Nuremberg, Germany in 1986. In 1989 he was Privatdozent, Senior Lecturer for Pharmacology and Toxicology at the Friedrich Alexander Universität, Erlangen-Nuremberg, and then in 1992 became a Specialist for Clinical Pharmacolgy, Charite, Humboldt Universität, Berlin. In addition to being Co-editor of the Journal Pharmacotherapy, Dr. Kurowski has been a consultatnt to the community of practicing physicians and Ciba-Geigy, a member of the "Drugs Commision", Chairte, University Hospital, and is an Associate Professor of Pharmacology and Toxicology, Martin Luther Universität Halle Wittenberg. Dr. Kurowski has received numerous awards and fellowships for his work. Dr. Kurowksi has been involved in clinical studies and analytics of analgesic and novel antiretrovial compounds since 1997 at the Private Practise Laboratory Medicine and was a Founder Therapia GmbH. He supervises not only PhD candidates but also medical students who are required to write a thesis in Germany. In addition to more than 50 publications in prestigious scientific journals he published 3 books.

Richard Lalong, PhD

Research Interests:

Richard is currently the Executive Director and Head of Clinical Pharmacokinetics and Pharmacodynamics at Pfizer Global Research and Development in Ann Arbor, Michigan. Prior to joining Pfizer (formerly Parke-Davis/Warner Lambert) in 1998, he was Senior Scientific Director at Phoenix International Life Sciences (now MDS) in Montreal, Canada. From 1984 to 1991, Richard was Assistant Professor then Associate Professor and Vice Chairman for Research at the University of Tennessee, Memphis. From 1980 – 1984 he worked at the University of Ottawa Health Sciences Centre in Ottawa, Canada. His research over the past 25 years has been focused on how to integrate pharmacokinetic and pharmacodynamic information to provide improved drug therapy in patients. He is a fellow of the American College of Clinical Pharmacology and the American College of Clinical Pharmacy and a member of the Editorial Board for Clinical Pharmacology and Therapeutics. Richard is a graduate of the University of Minnesota (Pharm.D.) and the University of Toronto (B.Sc. Pharmacy).

Lawrence J. Lesko, PhD Lawrence J. Lesko, Ph.D. is Director of the Office of Clinical Pharmacology and Biopharmaceutics (OCPB) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (1995-present). This Office is responsible for the review and evaluation of the biopharmaceutic, pharmacokinetic and pharmacodynamic data contained in IND’s and New Drug Applications (NDA’s). Dr. Lesko is also Chair of the Clinical Pharmacology Section of the Medical Policy Coordinating Committee, and Co-Chair of the Biopharmaceutics Coordinating Committee, in CDER that is responsible for developing guidances for industry. Dr. Lesko currently represents FDA on the Common Technical Document (Efficacy) Working Group in the International Conference on Harmonization. Dr. Lesko was previously Associate Director of Research at the FDA where he was responsible for developing and managing the Product Quality Research Program in the Office of Generic Drugs (1992-95). Prior to joining FDA, Dr. Lesko was Vice President of PharmaKinetics Laboratories (1988-92) and Associate Professor of Pharmaceutics at the University of Maryland at Baltimore (1981-88). He also held an appointment in the Laboratory of Neuroscience, National Institute on Aging, National Institutes of Health, from 1985-1988 investigating the effects of age on the pharmacokinetics and pharmacodynamics of drug substances. He was a Laboratory Director in the Clinical Pharmacology Division of the University of Massachusetts Medical Center from 1979-1981 and was on the faculty of the Massachusetts College of Pharmacy from 1973-1979. Dr. Lesko received his B.S. and Ph.D. degrees in pharmaceutics from Temple University in Philadelphia, Pennsylvania and was board certified in Clinical Pharmacology by the American Board of Clinical Pharmacology in 1992. In 1998, Dr. Lesko was awarded the Outstanding Alumni Award from Temple University. He is a member and Fellow of American Association of Pharmaceutical Sciences and serves as Chair of the Drug Development and Regulatory Science Section

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 11 of 23 of American Association of Clinical Pharmacology and Therapeutics. Dr. Lesko is a Fellow and a member of the Board of Regents of the American College of Clinical Pharmacology. He is also the FDA’s Federal Liaison to European Federation for Pharmaceutical Sciences. Dr. Lesko has authored or co- authored over 125 peer-reviewed articles in biopharmaceutics and clinical pharmacology and he is a frequent speaker at national and international meetings.

Nicola Luciani, BS

Research Interests:

Mr. Nicola Luciani is a Registered Pharmacist with the Ontario College of Pharmacy, having received his Bachelor of Science Degree in Pharmacy from the University of Toronto in June 1994. He currently holds the position of Pharmacy Manager with Dell Pharmacy in Hamilton, Ontario, Canada and has been working for Dell since September 1994. Mr. Luciani is an accomplished Compounding Pharmacist specializing in Veterinary Medicine and Advanced Sports Medicine. Mr. Luciani also holds a Doctorate of Acupuncture from Medicina Alternativa, received in April 2000. He has additional special interests in Nutrition, Anti-Aging and Botanical Medicine. He is currently a Board Member of SportPharm Pharmaceuticals, California, USA. Mr. Luciani is a Consultant and Lead Facilitator for Medisca Network Inc. for Certificate Programs in Pharmacy specific to Pharmaceutical Compounding; accredited by and offered at the University of Florida College of Pharmacy.

Maureen A. McKenzie, PhD

Maureen A. McKenzie, Ph.D. is the Chief Executive Officer of DENALI BioTechnologies, L.LC. Dr. McKenzie has almost 20 years of experience in biotechnology as an entrepreneur, researcher and executive, and founded the first and only company in Alaska dedicated to pharmaceutical and nutraceutical discovery and development from boreal territories. DENALI BioTechnologies focuses on plants, microbes, and marine organisms that thrive in harsh habitats, with special emphasis on novel molecules from psychrophiles (“cold-lovers”). Dr. McKenzie was Affiliate Assistant Professor in the Department of Physiology and Pharmacology at the College of Veterinary Medicine of Iowa State University, Ames, in 1994, and was an Assistant Professor of Chemical Biology and Pharmacognosy and member of the Laboratory for Cancer Research in the College of Pharmacy at Rutgers, The State University of New Jersey, New Brunswick, from 1990-1993. From 1989-1990, she was a Research/Teaching Specialist in the Departments of Biochemistry and Environmental and Community Medicine of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, Piscataway, New Jersey. Dr. McKenzie was a Staff Fellow Scientist in the Diabetes Branch of the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, from 1987-1989. Prior to graduate school, she was a Microbiologist for the Mobil Oil Corporation, Princeton, New Jersey, from 1979-1981. Dr. McKenzie received a Diabetes Research and Education Foundation Fellowship in basic research from the Hoechst-Roussel Corporation (1990-1992), The New Jersey State Commission for Cancer Research -Ciba Geigy Corporation Award for Scientific Excellence in Cancer Research (1992), and the Epsilon Award for Teacher of the Year in the College of Pharmacy at Rutgers University (1993). She was selected by the American Chemical Society in 1993 as a Preceptor for Science Experience for the Economically Disadvantaged. In 1994, she was chosen by the Des Moines Register as an Iowa “Up and Comer” for extraordinary leadership in business. In 1995, she received the Linda K. Neuman Award for the Professions by the Quad-Cities Women’s Encouragement Board, and was honored as a “Woman of Spirit and Note” in the community. She served on the Board of Directors of the Quad-Cities Chapter of the American Red Cross in 1995. She has authored or co-authored numerous peer-reviewed articles, patents and is the editor-in-chief of the Encyclopedia of Medicinal Plants scheduled for publication in 2006. Dr. McKenzie holds a Ph.D. in Biochemistry from a joint program of Rutgers, the University of Medicine and Dentistry of New Jersey and Princeton University (1987), a M.S. in Food Science from Rutgers (1982) and a B.S. in Nutrition/Food Technology from Iowa State University (1978).

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 12 of 23 Markus Müller, MD Markus Müller, M.D. is Head of the Department of Clinical Pharmacokinetics at the University of Vienna Medical School / Vienna General Hospital in Austria. He is also Co-Chair of the Clinical Pharmacology Section of the Austrian Pharmacological Society and the Austrian delegate to the European Association for Clinical Pharmacology and Therapeutics. He holds the position of an ao.Professor for Internal Medicine and Clinical Pharmacology. He has received his M.D. from the University of Vienna Medical School with highest possible honours (sub auspiciis praesidentis rei publicae). He was trained in Emergency Medicine, Oncology, Endocrinology, Infectious Diseases, Chemotherapy and Angiology and is board certified for Internal Medicine in Austria. Dr. Müller is a frequent speaker at international meetings and a reviewer for several biomedical and pharmaceutical journals and scientific societies.He has published over 70 original articles in the field of clinical pharmacology and has received several national awards including the Achievement Award of the Austrian Ministry of Science and the Billroth Award of the Austrian Board of Physicians.

Adolf Nahrstedt, PhD

Education in Pharmacy (1962 – 1966) and Food Chemistry (1966-1968) at the University of Freiburg/Germany. PhD (Pharmacognosy) Freiburg, 1971; habilitation (Pharmaceutical Biology) Freiburg,1976; assoc. Professor of Pharmaceutical Biology, Techn. Univ. of Braunschweig/Germany 1977-1986; full Professor and chair of Pharm. Biology and Phytochemistry, Univ. of Münster/Germany, 1986-2004. Since Oct 2004 Prof. em.; Dr.h.c. of the Ovidius University, Constanta, Romania (2004). Honorary member of the Society of Medicinal Plant Research (GA; 2005). Scientific areas: Phytochemistry, physiological activity and biopharmaceutical aspects of traditionally used medicinal plants and their constituents. Biochemistry and physiology of secondary constituents of plants and insects, in particular the cyanogenic compounds; >190 papers in these fields; >160 lectures; >120 posters together with coworkers and students.Teaching experiences: Analytics of natural products and plant secondary constituents; Phytochemistry and biochemistry of nature-derived drugs; Pharmacology of crude drugs and plant derived compounds; Pharmacognosy (microscopy) of crude drug material; Morphology and anatomy of plants. Member of the Committee of Experts "Pharmaceutical Biology (Pharmacognosy)" of the German Pharmacopoeia (since 1987); Member of the “Board of Directors” of the Gesellschaft für Arzneipflanzenforschung (Society of Medicinal Plant Research, 1981-2005) and the “Board of Directors” of the Gesellschaft für Phytotherapie (Society of Phytoptherapy, 1995-2004); deputy- member of the Commission E of the Federal Institute of Medicinal Products and Medical Advices (2002- 2004). Coeditor of Planta Medica 1983 - 1992; Editor in Chief of Planta Medica - Natural Products and Medicinal Plant Research" (1993 - 2004), since then Senior Editor of Planta Medica.

Emil Pop, PhD Research Chemist (1962-1965); Research Scientist (1965- 1978); Principal Research Scientist, Group Leader (1978- 1983) Chemical Pharmaceutical Research Institute, Cluj, Romania. Visiting Scientist, The Rugjer Boskovic Institute, Zagreb, Croatia (1971-72). Postdoctoral Research Associate, University of Florida, Gainesville, FL (1983-86). Senior Research Scientist (1986- 87); Group Leader (1987- 89); Associate Director for Chemical Development (1989-1992; Director of Chemistry (1992), Pharmatec, Inc., Alachua, FL. Director of chemistry (1992-95); Senior Director of Chemistry (1995-1998), Pharmos Corporation, Alachua, FL. Founder, President and CEO, Alchem Laboratories Corporation, Alachua, FL (1996-); Awards: The "N. Teclu" award for chemistry granted by the Romanian Academy (1980), Honors, Distinctions: Fellow, American Institute of Chemists, Who’s Who in: Frontiers of Science and Technology; World; Science and Engineering; South and Southeast; America (Marquis). Men of Achievement, Dictionary of International Biography, The International Who’s Who of Intellectuals, American Men and Women of Science. Courtesy Professor, Center for Drug Discovery, University of Florida; Inaugural Member of the Advisory Board, Florida Center for Heterocyclic Compounds, University of Florida.Professional Membership: ACS, AIC, AAAS, AAPS, IUPAC, New York Academy of Sciences, International Society of Quantum Biology and Pharmacology, Association de Pharmacie Galenique Industrielle.Scientific Activity: 119 publications, 23 patents, 127 presentations. Expertise: organic,

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 13 of 23 pharmaceutical, medicinal and theoretical chemistry. Drug design, synthesis and evaluation of novel drugs, prodrugs, chemical drug delivery systems; chemistry of synthetic cannabinoids. Basic research scale-up product and process development.

Lakshmi Putcha, PhD, FCP

Shashank Rohatagi, PhD, MBA

Dr. Rohatagi, is a Distinguished Scientist in Global Biopharmaceutics, Aventis Pharmaceuticals, NJ. Global Biopharmaceutics Dept. uses PK/PD modeling/simulation methodologies and conducts biopharmaceutics related clinical studies to support the development and approval of drug candidates. Prior to joining Aventis Pharmaceuticals (formerly Rhone Poulenc Rorer) in 1996, Dr. Rohatagi was senior pharmacokineticist at Somerset Pharmaceuticals, Tampa, FL. He received a PhD degree in Pharmaceutics from the University of Florida, Gainesville, FL in 1995 and an MBA degree from St. Joseph's University in 2000. Dr. Rohatagi received his B.Pharmacy degree from Birla Institute of Technology and Science, Pilani, India in 1991. His main interest is in elucidating pharmaceutical principles especially pharmacokinetics and pharmacodynamics in the field of asthma, cardiovascular disease and CNS. Dr. Rohatagi has currently published more than 30 peer reviewed articles, given more than 40 poster or oral presentations at various national and international meetings. He is currently a Fellow of American College of Clinical Pharmacology. He serves on the Editorial Board of the Journal of Clinical Pharmacology.

Hans Schreier, PhD Dr. Hans Schreier is a founder and CEO of MCS Micro Carrier Systems GmbH, a formulation development company based in Neuss, Germany. He received his dipl. pharm. ETH degree in 1976 and his Dr. sc. nat. degree in 1981 from the Swiss Federal Institute of Technology (ETH) Zurich, Switzerland, followed by postdoctoral training from 1981-1983 at the University of California – San Francisco (UCSF) and a Senior Scientist position at Liposome Technology, Inc., in Menlo Park, California from 1983-1986. During his academic career, he held appointments as Assistant Professor and Associate Professor of Pharmaceutics at the University of Florida College of Pharmacy (1986-1993) and Associate Professor of Medicine at Vanderbilt University School of Medicine (1993-1995). He has been a founder, Director and the Principal Scientist of Advanced Therapies, Inc., a nonviral gene delivery company (1995-1998) and is a co-founder of ARYx Therapeutics, Los Altos Hills, CA, a virtual drug discovery and pharmaceutical development company. He is the Executive Director of Liposome Research Days, Inc., a non-profit organization (since 1994) and co-organizer of the biennial international "Liposome Research Days" conference. He has published over 70 articles, reviews and book chapters and holds several patents. He is the editor of a recent book on 'Drug Targeting Technology: Physical, Chemical and Biological Methods' (Marcel Dekker, 2001). He is an Editorial Board member of the Journal of Liposome Research, and a member and elected Governor (1996-1999) of the Controlled Release Society (CRS). He maintains extensive professional links with individuals, companies, agencies and scientific organizations in the US, Europe, Japan, and Australia.

Sean Sullivan, PhD

Dr. Sullivan has been in the field of drug delivery for the past 13 years with emphasis being placed on increasing the effectiveness of drugs and decreasing side effects. Areas of therapeutic applications have included infectious disease (HIV, HSV and Hepatitis), arthritis and cancer. The drug delivery vehicles have included both liposomes and polymers for small molecular weight, such as doxorubicin and large molecular weight drugs, such as oligonucleotides and plasmids. For the past 6 years, his research efforts have applied this technology toward the development of non-viral gene delivery systems. Non-viral gene delivery systems consist of plasmid DNA encoding a therapeutic gene isolated from bacteria and formulated with either cationic lipids or polymers yielding transfection complexes. The cationic lipid based transfection complexes were developed for transfection of tumor endothelial cells for the purpose of

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 14 of 23 inhibiting tumor angiogenesis. A combination of peptide targeting to receptors on tumor endothelial cells and control of therapeutic gene expression by proliferating endothelial cell promoters are being developed to yield selective delivery and therapeutic gene expression to the tumor vasculature. In addition, polymer based formulations are being developed for intramuscular administration. The purpose is to convert the transfected muscle cells into bioreactors for expression and secretion of therapeutic proteins into the blood stream. His present research program is focused on applying these technologies to the treatment of cancer, with emphasis being placed upon brain cancer.

Melanie Pecins-Thompson, PhD

Dr. Thompson received her B.S. from University of Florida in 1989, and her Ph.D. in Pharmaceutical Science from the University of Florida in 1993. She held a research position at the Oregon National Primate Research Center. While at the Oregon National Primate Research Center, Dr. Thompson received a National Research Service Award which funded her postdoctoral studies. She was also a recipient of A Women in Endocrinology travel award. Her primary research interests are the effects of steroid hormones on serotonin neural function. She has also taught Endocrinology at Portland State University.

Markus Veit, PhD Academic Positions: January 1991 – December 1996: Lecturer and position equivalent to an Assistant Professor (C1) since 1.4.1997: position equivalent to an Assistant Professor (C2) , Department of Pharmaceutical Biology, University, Würzburg, Germany Non academic positions: since October 1999: Managing & Scientific Director, Zentralinstitut für Arzneimittelforschung GmbH. Since December 1999: Scientific Director of the German Pharmaceutical Manufactures Research Association

Susan Way, PhD

Dr. Way received her BS in Chemistry and Biology from Georgetown College, Georgetown, KY in 1983. She later received her Ph.D. in Pharmaceutical Sciences from the University of Kentucky in 1992. She has worked in the pharmaceutical industry since 1992 and is experienced in both solid and non-solid dosage form development. She is currently a Senior Principal Scientist in the Pharmaceutics Department at Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT. where her responsibilities include preclinical and clincial dosage form development and preformulation. This includes discovery interfacing to assist in the selection of compounds entering development. Her research interests include solubilization of poorly water soluble compounds, promotion of oral absorption, as well as in vitro/in situ models for assessing drug transport

Governance Decisions concerning curricular revision and student admissions are made after the department faculty has met to discuss such matters and each faculty member has voted on that particular issue.

Recruitment of Students The PhD program of the Department of Pharmaceutics is listed in the graduate catalog, and is advertised in mailings to well qualified graduates of the University of Florida and on the College of Pharmacy Home Page on the Internet.

Admission Policies and Procedures The College of Pharmacy adheres to the minimum standards set forth by the Graduate School:

z A grade point average (GPA) of at least 3.0 (4-point system); z Three (3) letters of recommendation.

In addition to the above requirements, foreign applicants must have: http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 15 of 23

z All international students seeking admission to the Graduate School must submit satisfactory scores on the GRE General Test

Although a formal interview is not required at this time, applicants are encouraged to visit the department/center prior to or during the application process.

Financial Assistance It is the general policy of the Department of Pharmaceutics that all students accepted to pursue graduate studies receive support in the form of a teaching or research assistantship, or show evidence of adequate support from a fellowship or other source. Currently, the minimum stipend is approximately $14,000/year.

Teaching assistantships are normally provided for a four (4) year period of time contingent upon continuing funding from State sources. A student may receive support for one (1) more year if a relevant reason is presented to the departmental faculty by the major advisor, and the departmental faculty approves the request by majority vote of all the faculty. Except in extenuating circumstances, the department or the center is not financially responsible for any student taking longer than 5 years to complete the doctoral program.

Those students assigned to teach during any given semester by the graduate studies coordinator are appointed Teaching Assistant (0.33 FTE) and are required to work 13.3 hours per week. All graduate students receiving a stipend who are not employed as teaching assistants will be designated Research Assistants or Fellows depending on the source of funds. Stipends are provided so that students may pursue research required to complete their educational programs. Students are expected to diligently pursue that research.

Prior to the beginning of each fiscal year, every graduate student will receive a statement specifying (i) total amount of stipend for that period, (ii) position to which appointed, e.g. TA, R.A., or other, (iii) starting and ending dates of appointment, (iv) assignment for that period, (v) the supervisor for that period, and (vi) other pertinent information. A copy of this document will be kept in the student's personnel file. Students will be asked to sign the form to indicate that it has been read, understood and accepted.

At the end of each fiscal year, each student will be evaluated on his/her assigned duties by the supervisor in writing. The student has the right to a written rebuttal in case he/she does not agree with the evaluation. The evaluation will also be kept in the student's personnel file.

A professor may usually not have more than three (3) College-supported graduate students at any one time.

A faculty member may support with his/her own funds any number of graduate students in addition to the College-supported graduate students. The stipend paid by the faculty member cannot be used to supplement an existing college supported stipend.

Students are encouraged to apply for national and graduate school fellowships and awards. If a student succeeds in receiving a grant, the department or the center may supplement the student's salary with a fraction of the amount up to the current funding levels (provided the granting agency allows such an arrangement).

Decisions concerning the allocation of state stipends are made by the departmental/center faculty at the same time as a decision is made to admit a particular candidate.

Selection of Discipline for Degree and Major Professor Upon entering the department, students are required to meet with each faculty member before selecting http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 16 of 23 an advisor. Even if a student indicates an interest in working with a particular faculty member, he/she must nevertheless interview with all (graduate) faculty members of the whole department before a final decision is made. However, students who have made individual arrangements with a professor prior to entering the program and are sponsored through non-College funds provided by this professor will not need to go through this selection process.

Students must select a major advisor by the end of their second semester of graduate school but are encouraged to do so as early as possible.

If a student desires to change the major advisor, he/she must discuss the change with the current advisor. If both parties agree to such change, the student can select a new advisor. If the parties cannot come to an agreement concerning the proposed change, then the student and the faculty member must each write a letter to the department chairperson explaining the situation. The student must specify the reason(s) for wanting to change. The advisor's letter must specify the reason(s) for the disagreement and contain an overall evaluation and appraisal of the situation. The department chairperson will evaluate the letters, discuss the situation with both individuals, and make a decision. If the student is permitted to change advisors, he/she will not be allowed to continue the same research project with another faculty member, except if both faculty members agree in writing to the department chairperson that the student should continue the same project under the new advisor.

The department graduate coordinator will advise the student in general policies as set forth in this document. This individual is also responsible for general oversight of the graduate program for quality assurance, assignment of teaching duties, and recruitment of graduate students.

Supervisory Committee The supervisory committee is proposed by the student's major advisor in consultation with the student, nominated by the department chairperson, approved by the Dean of the College of Pharmacy, and appointed by the Dean of the Graduate School. Each committee member should hold Graduate Faculty status with the Graduate School. The Dean of the Graduate School is an ex-officio member of all supervisory committees. The supervisory committee must be appointed no later than the second term of the doctoral program. The student is encouraged to meet with the supervisory committee as often as possible.

The supervisory committee shall consist of at least four (4) members of the Graduate Faculty. At least two (2) members must be from the Department of Pharmaceutics, and at least one (1) member other than the chairperson must be tenured faculty; at least one (1) member must be from a different educational discipline outside the College of Pharmacy. The chairperson need not be tenured, but must hold a full-time tenure track position in the Department of Pharmaceutics.

In unusual cases, the doctoral research may require the guidance of a specialist in an area of study other than that of the supervisory committee chairperson. In such cases, the department chairperson may recommend the appointment of a co-chairperson who should be on the graduate faculty.

DUTIES OF THE SUPERVISORY COMMITTEE

z To provide optimum support and guidance to the student to help the student meet his/her academic goals. z Inform the student of all regulations governing the Ph.D. degree. This does not absolve the student from the responsibility of becoming informed of these regulations. z To meet soon after appointment with the student to consider the student's individual goals and proposed program, and evaluate the student's progress to date. z To conduct the student's written qualifying examination after the student has completed all required course work. The supervisory committee should also assist in the departmental oral qualifying exam. After successful completion of the written and oral exam the committee will also

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 17 of 23 discuss and approve the student's dissertation topic, and, if the student has passed the examination to the committee's satisfaction, recommend the student's admission to candidacy. z The supervisory committee should monitor and evaluate the student's progress and give clear directions as to the final work plan leading to graduation. It is recommended that the committee meets once a year before the student advances to candidacy and every six months thereafter to review the student's research and to make suggestions for completion of research, and approve that the student is ready to write up the dissertation as soon as the major advisor and student believe that the research is nearing completion. z To conduct the final oral examination in defense of the thesis.

Curriculum A minimum of 90 semester hours beyond the Bachelor's degree is required for the doctoral degree. All credits earned in the approved degree program count toward this minimum. Course work must be 5000 level or higher. Courses for major credit must be taken by letter grade, except for those courses listed as S/U in the catalog.

Each student, together with his/her committee, will put together a course program of study specifically designed to meet the student's interest this will include the following core courses:

z A statistics course: Statistics STA 6166 (4 credits), or Analysis of Research Data STA 6201 (3 credits) z A Drug Metabolism Course (For example PHA 6425 or Pharmacogenomics PHA 6449) z Ethics Course (VME 676 or equivalent) z Grant Writing Course (ALS 6046 or equivalent) z Pharmaceutical Analysis (PHA 6416)

Course Schedule for required courses

PHA 6414 Pharmaceutical Analysis Spring 2007, Spring 2009, ODD Numbered Years

PHA 6425 Drug Metabolism & Toxicity Fall 2005, Fall 2007, Fall 2009; ODD Numbered Years

VME 6767 Ethics Spring 2006, Spring 2007

ALS 6046 Grant Writing Spring semesters

Students with adequate training in any of the above courses may apply for exemption from such courses, but they must have credit for a minimum of thirty (30) semester hours of approved didactic courses. The remaining course requirements can be fulfilled by completion of electives from the provided list or the graduate catalog selected in consultation with the students advisory committee. I t is also essential that the student ensure that they have a basic understanding of Pharmaceutics either by taking the appropriate classes or from previous education. They should be proficient in the basics sciences at a minimum to the same degree as students in the professional program. QUESTIONS WILL BE ASKED DURING THE ORAL QUALIFYING EXAM Following is a list of approved courses. Course numbers may change, and courses may be added or deleted upon approval by the Faculty.

The following are course the students should consider taking to become familiar with Pharmaceutics

PHA 5172 Pharmaceutical Biotechnology Fall 2005, Fall 2006, Fall 2007

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 18 of 23 PHA 5475 Synthesis of Prodrugs Fall 2006, Fall 2008, Fall 2010

PHA 6116 In vivo and In vitro stability of drugs Fall 2006, Fall 2008, Fall 2010

PHA 6125 Advanced Pharmacokinetics Spring 2006, Spring 2008, EVEN Numbered Years

PHA 6170C Product Formulation Fall 2005 Fall 2007, Fall 2009, ODD Numbered Years

PHA 6183 Pharmaceutical Gene Delivery Spring 2007, Spring 2009

PHA 6185 Pharmaceutical Drug Developement, Fall 2008

PHA 6427 Pharmacogenomics of drug metabolism and transport, Fall 2006, EVEN Numbered Years

PHA 6449 Pharmacogenomics #1 Fall 2005 ODD Numbered Years

LIST OF APPROVED GRADUATE COURSES: PHA 5161 - Pharmaceutical Biotechnology (3 credits) PHA 5475 - Synthesis of Prodrugs (3 credits) PHA 5515 - Introduction to Pharmacology (1 credit) PHA 5516 - Pharmacological Basis of Therapeutics (4 credits) PHA 5517 - Pharmacology II (4 credits) PHA 6115 - Equilibria, Complexations, and Interactions of Drugs (3 credits) PHA 6116 - In Vivo and In Vitro Stability of Drugs (3 credits) PHA 6118 - Molecular Diversity (2 credits) PHA 6125 - Advanced Pharmacokinetics (3 credits) PHA 6170C - Pharmaceutical Product Formulation (3 credits) PHA 6354 - Natural Medicinal Products (3 credits) PHA 6416 - Pharmaceutical Analysis I (3 credits) PHA 6417 - Pharmaceutical Analysis II (3 credits) PHA 6425 - Drug Metabolism & Toxicity (3 credits) PHA 6445 - Drug Discovery (3 credits) PHA 6508 - Mammalian Physiology (4 credits) PHA 6509 - Mammalian Physiology (4 credits) BCH 6206 - Advanced Metabolism (3 credits) BCH 6740 - Advanced Physical Biochemistry (3 credits) BCH 7515 - Enzyme Kinetics and Mechanisms (2 credits) BMS 5201 - Introduction to Biochemistry and Molecular Biology (3 credits) BMS 5520C - Principles of Physiology (2 credits) BMS 6400 - Introduction to Pharmacology (5 credits) BMS 6402 - Autonomic and Cellular Pharmacology (2 credits) CAP 5506 - Programming Language Principles [3 credits) CAP 6627 - Expert Systems (3 credits) CAP 6652 - Artificial Intelligence Concepts (3 credits) CAP 6653 - Neuroal Networks for Computing (3 credits) CHM 4411 - Physical Chemistry (4 credits) CHM 5224 - Basic Principles far Organic Chemistry (3 credits) CHM 5235 - Organic Spectroscopy (3 credits) CHM 5275 - The Organic Chemistry of Polymers (2 credits) CHM 5305 - Chemistry of Biological Molecules (3 credits) CHM 5514 - Chemical Computations (2 credits) CHM 6154 - Chemical Separations CHM 6155 - Spectrochemical Methods (3 credits] CHM 6225 - Advanced Principles of Organic Chemistry (4 credits) OHM 6226 - Advanced Synthetic Organic Chemistry (3 credits) CHM 6211 - Chemistry of High Polymers (2 credits) CHM 6480 - Elements of Quantum Chemistry (3 credits) CHM 6520 - Chemical Physics (3 credits) CHM 6720 - Chemical Dynamics (3 credits) CHS 5110 - Radiochemistry (2 credits) CHS 5110L - Radiochemistry Laboratory (3 credits) GMS 6500 - Introduction to Pharmacology (5 credits) GMS 6563 - Molecular Pharmacology (3 credits) GMS 6735 - Neuropharmacology (3 credits) GMS 7593 - Principles of Drug Action (2 credits) GMS 7595 - Topics in Pharmacology (e.g. Principles of Drug Action, 2 credits) MBS 7423 - Principles of Drug Action (2 credits) STA 6166 - Statistical Methods in Research I (4 credits) STA 6167 - Statistical Methods in Research II (4 credits) STA 6200 - Fundamentals of Research Design (2 credits) STA 6201 - Analysis of Research Data (3 credits) VME 6767—Issues in the Responsible Conduct of Research (1 credit), ALS 6046 - Grant Writing (2 credits)

z ALL GRADUATE STUDENTS should register for (a) the 1 credit Pharmaceutics Department

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 19 of 23 research seminar each semester, using number PHA 6938 (Research Seminar; 1 credit; S/U option; maximum 3 credits). z FOR NON- CANDIDATES: Graduate students who have not yet attained candidacy for the Ph.D. should register for PHA 7979 (Advanced Research; 1 to 9 credits). z FOR CANDIDATES: Candidates for the Ph.D. degree should register for PHA 7980 (Research for Doctoral Dissertation; 1 to 15 credits).

Qualifying Examination Satisfactorily passing the qualifying examination is a requirement for admission to candidacy, i.e., when the student actually becomes a candidate for the Ph.D. degree. In order to take the qualifying examination, the student must (I) have a minimum 3.00 GPA; (ii) have completed letter-grade course work; (iii) have completed all core courses; and (iv) be registered at the time the examination is taken. Exceptions (e.g., if a core course is not offered, but the student has fulfilled all other requirements and has formulated a research program) may be granted by the supervisory committee. It is expected that the qualifying exam will focus on the student’s own prepared NIH grant proposal but in addition background information from course work and a general questions of pharmaceutics is also expected of the student.

General Guidelines

z The format for the comprehensive examination will be a combined written/oral examination. z The comprehensive examination should be completed at or about the time when all course work is completed and no later than eight months prior to scheduling of the dissertation defense. It is expected that the oral comprehensive examination will be taken by the end of the third year in the graduate program. z The written part of the comprehensive examination committee for each student will be chaired by a faculty member in the Department of Pharmaceutics who is a member of the graduate faculty. The student’s academic advisor will be a member of the committee but may not be the committee chair. Composition of the committee will be consistent with University guidelines for dissertation committees (i.e., at least four faculty members with the majority being graduate faculty). It is anticipated that the examination committee will subsequently serve as the dissertation committee. z The comprehensive examination committee members will have a meeting prior to the comprehensive examination to discuss lines of questioning and to address core competencies (relative to each focus area). The chair of the examination committee will communicate the proceedings of this meeting to the Graduate Program Administrator. The oral part of the exam is open to the entire department.

Guidelines for proposal Preparation

1. The topic of the research proposal must be an original research project. The topic may be the student’s proposed dissertation research. A written abstract of the research proposal, maximum of one page in length, should be examined and approved by the academic advisor and the oral comprehensive examination committee prior to preparation of the complete proposal.

2. The written proposal, maximum of 10 pages of text plus references, prepared in the format of a granting agency (e.g., NIH R03) should be distributed along with "key" references to the committee at least 14 days prior to the oral comprehensive examination.

3. The graduate student will give an oral presentation that should be succinct, yet complete (approximately 20-30 minutes), and be supported by visual aids (slides/overheads).

4. The committee will identify questions relevant to each research focus area, which may include but not be limited to:

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z Literature evaluation skills z Writing skills z Scientific background z Study design z Utility of animal models of disease or conditions relative to the human situation z Analytical methods z Clinical measurement methods z Data and statistical analysis skills z Differentiation of clinical and statistical significance z Basic Sciences covered in the Professional Program ( Physical Pharmacy, Biochemistry, Pharmacokinetics, Biochemistry, Pharmacology, Medicinal Chemistry and Statistics)

5. The final evaluation by the dissertation committee should be communicated to the student and the graduate academic affairs committee utilizing the following scale:

a. Pass - With written feedback on strengths and weaknesses

b. Remedial work needed:

z Specific needs for additional learning experiences (e.g., scientific area, statistics, writing, etc.) may be identified. z Remedial work may include a minor rewrite of the proposal or a major rewrite and re-defense of the proposal. z Remedial work must be completed within six months from the time of examination.

c. Fail - A student who fails the qualifying examination will be terminated from the Ph.D. program.

Oral Comprehensive Examination

Guidelines for Proposal Preparation

Procedures

Oral comprehensive exam proposals are to be submitted on NIH grant application form PHS 398 continuation pages (rev. 12/04) and prepared according to the directions in the application packet, with the exceptions noted below. Forms and instructions are available on the internet at:

http://grants.nih.gov/grants/funding/phs398/phs398.html

Research Plan

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 21 of 23 Do not exceed a total of ten pages for the following parts (a-d): Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Experimental Design and Methods. Tables and figures are included in the ten page limitation. Applications that exceed the page limitation or PHS requirements for type size and margins (Refer to PHS 398 application for details) will be returned for revision. The ten page limitation does not include parts e through i. (Human Subjects, Vertebrate Animals, or Literature Cited).

(a) - Specific Aims – (1 page). List the broad, long-term objectives and what the specific research proposed in this application is intended to accomplish, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, or develop new technology.

(b) - Background and Significance – (2-3 pages). Briefly sketch the background leading to the present application, critically evaluate existing knowledge, and specifically identify the gaps that the project is intended to fill. State concisely the importance and healthcare relevance of the research described in this application by relating the specific aims to the broad, long-term objectives.

(c) - Preliminary Studies/Progress Report – (2-3 pages). Use this section to provide an account of the students’/academic advisors’ preliminary studies pertinent to the application information that will also help to establish the feasibility of the proposed project.

(d) - Research Design and Methods – (4-5 pages). Describe the research design and the procedures to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted. Describe any new methodology and its advantage over existing methodologies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project.

See http://grants.nih.gov/grants/funding/phs398/section_1.html#8_research for complete instructions regarding sections (e) and (f).

(e) – Human Subjects Research

(f) – Vertebrate Animals

(g) – Literature Cited. (No page limits). List all references. Each reference must include the title, names of all authors, book or journal, volume number, page numbers, and year of publication. The reference should be limited to relevant and current literature. While there is not a page limitation, it is important to be concise and to select only those literature references pertinent to the proposed research.

Final Examination After submission of the original copy of the dissertation to the Graduate School (see below) and completion of all other work for the degree, and the appropriate dates and time intervals will follow the guidelines set forth by the University of Florida Graduate School, as detailed in the Graduate Catalog.

An announcement of the scheduled examination must be submitted in writing to the Dean of the Graduate School by the chairperson of the supervisory committee at least ten (10) working days prior to the scheduled date. An announcement of the examination is sent at least one (1) week prior to the date of examination to faculty members in the College of Pharmacy, inviting them to attend.

At least four (4) faculty members, including all members of the supervisory committee, must be present at the final oral portion of the final examination. The four (4) faculty members must be Graduate Faculty members. Only the official members of the supervisory committee may sign the dissertation signature pages.

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 22 of 23 Assuming the candidate is successful, the Final Examination Report shall be signed by all faculty members attending the examination. The dissertation, original and copies, are to be signed by the official members of the supervisory committee and by the Dean of the College of Pharmacy. The signed Final Examination Report and the original copy of the dissertation should be returned to the Graduate School after the dissertation has been corrected.

Every candidate for a doctoral degree is required to prepare and present a dissertation that shows independent investigation, and is acceptable in form and content to the supervisory committee and to the Graduate School. Since all doctoral dissertations will be published by microfilm, it is necessary that the work be of publishable quality and that it be in a form for publication. A draft copy of the dissertation must be given to the supervisory committee at least one month prior to the defense. This allows time for any major changes to be made. A final copy of the thesis should be circulated to the committee at least one week before the final defense.

All copies of the dissertation, except the original copy and the Health Center copy, must be provided as a hard bound copy by the student. The original copy and the second copy of the dissertation must be presented to the Dean of the Graduate School on or before the date specified in the University Calendar.

Students will not generally be admitted for studies toward an M.S. in this specialization. However, a student admitted to the doctoral program may be allowed to graduate with a Masters in Pharmacy subject to approval by the students supervisory committee. The M.S. in Pharmaceutical Sciences is described in the graduate catalog and requires the completion of a thesis or dissertation.

Specific Requirements for the Master of Science in Pharmacy Degree

Graduate Student Classification: Students pursuing the Master of Science in Pharmacy degree are classified 7PH.

Degree Requirements: Unless otherwise specified, for any master' degree, the student must carry a minimum of 30 credits including no fewer than 24 hours of regular course work and up to 6 credits in thesis research as a graduate student at the University of Florida, of which no more than six semester hours of course work earned with a grade A, B+ or B may be transferred from institutions approved by the Dean of the Graduate School.

Major: All course work for a master' degree must be in courses open only for graduate credit (5000 and above).

Credits and Grades: The 24 credits of minimum regular course work recommended by the supervisoy committe and the supervisory chair, must be taken by letter grade. The student must have a minumum 3.00 GPA for all course work attempted for the degree, and as well, a minimum 3.00 GPA for course work in the major. The course program will be determined by the thesis committee.

Thesis: The candidate is required to prepare and present a thesis acceptable to his/her supervisory committee and the Graduate School. He/she should consult the Graduate School for instructions concerning the forms of the thesis, binding, and the date when the original copy, accompanied by three (3) copies of abstracts are to be submitted to the Graduate School.

Supervisory Committee for the Master of Science in Pharmacy: At least three members selected from the Graduate Faculty must be on the supervisory committee. These members are recommended by the student's supervisory chair, approved by the College Dean for

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008 PhD in Pharmaceutical Sciences with Specialization in Pharmacy Page 23 of 23 Research and Graduate Studies, and appointed by the Graduate School. The Dean of the Graduate School is an ex-officio member of all supervisory committees. If a minor is designated, it should be represented by one member of the committee who is on the Graduate Faculty. The committee should be appointed as soon as possible, and no later than the end of the second semester or 24 credits, whichever comes first.

Only members of the Graduate Faculty may be members of the supervisory committee. Names of courtesy faculty, regular faculty, and others not on the Graduate Faculty should not appear on the student's official supervisory committee.

At least three faculty members must be present at the student's final examination, but only members of the official supervisory committee are required to sign the thesis and the report of the final examination.

Residency Requirement: There is no residency requirement for the master's degree.

Admissison to Candidacy: Admission to candidacy is no longer required for students pursuing master's degrees.

Final Examination: A written announcement of the examination is sent to the Graduate School Dean and all faculty in the College of Pharmacy. When all of the student's course work is completed, or practically so, and the thesis is in final form, the student's supervisory committee is required to examine him/her in writing or orally on his/her thesis and the subject matter of the courses taken for the degree. The form Report on Thesis/Dissertation and Final Examination should be completed and signed by the official members of the committee, and then by the department chair/center director and the College Dean. This form should then be submitted to the Graduate School.

The Final Examination Record should be submitted to the Graduate School with the thesis by the date specified in the University Calendar. The final examination may not be held any earlier than six month before the degree is to be conferred.

Time Limitation for Completion of The Master of Science in Pharmacy: All work counted toward the M.S.P. degree must be completed during the seven years immediately preceeding the date on which the degree is to be awarded.

Correspondence and Extension Work: No courses may be taken for graduate credit by correspondence. No extension courses may be used for graduate credit.

http://www.cop.ufl.edu/safezone/pat/pc/phd_prg.htm 2/25/2008

CURRENTLY ENROLLED GRADUATE STUDENTS – QUESTIONNAIRE AND RESULTS The College of Pharmacy is assessing the quality of all our graduate degree programs. We need to know what you think of the program to determine how you view your education including the faculty, coursework, research environment, and how the program is enabling you to meet your career objectives. Your responses will be held in the strictest confidence. Thanks for making the College of Pharmacy an even better place.

1. In what academic discipline (field) will you receive your Ph.D.? (total n=63 responses) Pharmaceutics 34 Medicinal Chemistry 11 ( out of 14 current students) Pharmacodynamics 7 Pharmacy Health Care Admin. 11

2. What was your undergraduate major? For Pharmaceutics students, 4 biological sciences, 2 biology, 2 biopharmaceutics, 1 botany, 1 BS, 1 chemical engineering, 1 math, 1 microbiology and PharmD, 1 pharmaceutical engineering, 1 pharmaceutical sciences, 1 pharmaceutics, 2 pharmacology, 14 pharmacy, and 1 pharmacy and chemical engineering.

3. Was your undergraduate degree from U.S. institution?

All Pharmaceutics Yes 19 11 No 42 21 No Answer 2 2

4. Presently, I am most interested in a career in: All Pharmaceutics Academia 18 8 Industry 31 15 Other 3 2 Don’t Know 10 8

5. If other, please specify

Answers were: healthcare consulting and small business

With regard to my choosing UF for graduate school, the most important considerations were (rank from 1 to 4)

Note: the survey did not specify whether 1 or 4 was favorable; one student noted in comments that she/he assumed 1 was low and 4 was high

All Students Mean Pharmaceutics Mean Ranking 1 2 3 4 All 1 2 3 4 Pharmaceutics 6. Reputations of 6 16 25 16 2.81 4 10 12 8 2.71 UF 7. Quality of 13 13 13 24 2.76 7 8 6 13 2.74 Faculty and Research 8. Geographic 9 12 27 15 2.76 4 8 15 7 2.74 location 9. Stipend level 12 13 22 16 2.67 8 7 12 7 2.53

How would you rate the following characteristics of your graduate experience? Key 1- very poor , 5 - excellent

All Students Mean Pharmaceutics Mean Rating 1 2 3 4 5 All 2 3 4 5 10. Level, 0 3 16 33 10 3.81 2 11 17 4 3.68 breadth, and content of course 11. Quality of 0 5 16 33 9 3.73 5 9 16 4 3.56 Instruction 14.Mentoring 2 3 14 26 18 3.87 2 1 10 12 9 3.74 Guidance 15.Career Guidance 3 6 25 19 8 3.39 1 2 16 9 6 3.5 16. Research 1 6 13 24 18 3.84 4 9 9 12 3.59 Environment 17. Program activities 1 7 10 33 12 3.76 5 5 18 6 3.74 (eg. Seminars) 18. Interactions with 3 4 13 24 19 3.83 1 2 6 17 8 3.85 fellow students 19. Thesis Advisory 3 6 13 23 13 3.64 2 1 8 15 7 3.44 20. Program 2 8 17 23 11 3.54 2 6 12 9 5 3.26 Administration 21. Regular Feedback 3 10 18 19 12 3.44 3 4 10 8 9 3.47 regarding progress towards degree 22. Mechanism for 3 8 24 18 7 3.3 2 5 15 8 3 3.15 addressing grievances 23. Overall level of 2 6 11 34 10 3.7 2 2 8 17 5 3.62 satisfaction 24. Thesis committee 4 4 13 22 14 3.67 2 9 13 8 3.84

25. If you could make the decision over again, would you attend the University of Florida for your graduate education? All Pharmaceutics Yes 45 23 No 3 3 Not Sure 14 7 No Response 1 1

Alumni Questionnaire and Survey Results

The College of Pharmacy is assessing the quality of all our graduate degree programs. As a former student your input is an integral part of his process. To that end we are asking you to please take a moment to complete the following survey. Your responses will be held in the strictest confidence. Thanks for making the College of Pharmacy an even better place.

1. In what academic discipline (field) did you receive your Ph.D.?

Total responses -59 Pharmaceutics- 21

2. How many years did you spend as a full-time student and/or part-time student between receiving your first baccalaureate degree (or first professional degree or equivalent) and receiving your doctorate (including the period you spent on your thesis and/or dissertation)?

Years as full-time Years as part-time All Pharmaceutics All Pharmaceutics 4.97 ± 2.16 4.67 ± 1.49 .5-8(n=7 of the 59) 0

3. Which of the following classes, programs, training, seminars, and/or activities were provided to you during your Ph.D. experience to prepare you for your professional life?

All Pharmaceutics Was Was Would Was Was Would provided helpful have provided helpful have liked liked Leadership/management 12 10 31 3 3 14 training Interdisciplinary work 14 29 13 6 10 4 Cross-cultural/international 20 21 13 9 8 3 experiences Technology Training 17 25 14 5 11 4 Externships/internships 9 10 33 5 4 11 Mentoring 19 31 7 10 7 3

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4. To what extent did earning a Ph.D. at UF make a difference in your career?

Scale 1 no difference 2 3 4 5 impossible to do without All Pharmaceutics 1 2 3 4 5 Scale 1 2 3 4 5 1 1 4 19 34 Number of respondents 0 0 1 6 14

5. Please Indicate the sector in which you are currently employed. All Pharmaceutics Business or industry 21 11 Government agency 5 2 National Laboratory 1 0 Non-profit organization 3 2 Medical facility 2 1 Research-intensive 22 4 academic institutions Teaching-intensive 3 1 academic institution (liberal arts or community college, Master’s-granting institution) Self-employed 0 Other 2 still looking

6. In your current position, how do you participate as a scholar in your field? Check all that apply. All Pharmaceutics Faculty position 18 4 Publishing 32 11 Research 47 16 Non-profit Work 11 2 Community Service 14 4 Public Speaking 19 6 I no long participate as a 4 scholar in my particular field

7. If you are now or were previously employed by an institution of higher education: What is/was your faculty rank? Check only one. All Pharmaceutics Professor 2 Associate Professor 8 Assistant Professor 11 2 Instructor 2 3 Lecturer 1

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Adjunct faculty 3 Other Please specify 4 Does not apply 22 14 (only two options were associate and assistant professor) Other-all were post-doctoral fellows

8. How would you rate the following characteristics of your graduate experience? Key 1 –worst 5-best

Level, breadth, and content 4.2 ± 0.8 4.29 ± 0.96 of course Quality of Instruction 4.3 ± 0.8 4.10 ± 1.0 Mentoring guidance 4.3 ± 1.1 4.24 ± 0.98 Career guidance 3.4 ± 1.2 3.29 ± 1.38 Research environment 4.3 ± 0.9 4.19 ± 0.98 Program activities (eg 4.0 ± 1.1 3.76 ± 1.13 seminars) Interactions with fellow 4.4 ± 0.9 4.15 ± 1.09 students Thesis advisory committee 4.3 ± 0.9 3.95 ± 1.07 Program administration 3.9 ± 0.9 3.8 ± 1.00 Regular feedback regarding 4.0 ± 1.0 3.81 ± 1.12 progress toward degree Mechanism for addressing 3.7 ± 1.1 3.15 ± 0.75 grievances Overall level of satisfaction 4.4 ± 0.9 4.33 ± 0.97 Thesis committee 4.4 ± 0.9 4.05 ± 1.00 N= 59 N = 20, 21

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April 16, 2008

To: Dr. Anthony Palmieri, Dr. William Millard From: University of Florida Pharmaceutics Graduate Program Review Team: Cheryl L. Zimmerman, Ph.D. University of Minnesota, Chair Rudy Juliano, Ph.D., University of North Carolina Iklis Khan, Ph.D. University of Mississippi

The Pharmaceutics Graduate Program Review Team (PRT) visited the University of Florida Department of Pharmaceutics on March 19-20, 2008. Jeffrey Hughes, the graduate program coordinator, was our host and had previously made available to us the “self-study” document for the graduate program. The self-study document was somewhat limited and the PRT needed to specifically request information such as the research funding of individual faculty members, list of graduate students, complete information on the alumni and a list of graduate student publications. Based on the self-study document and our visits with faculty, graduate students and administrators, we report our findings.

Pharmaceutics Graduate Program Strengths 1. The Pharmaceutics graduate students are generally satisfied with their educational experience. • The students indicate that there are very positive interactions between faculty and students and a good atmosphere for learning.

2. There exist some strong individual peer-reviewed and externally-funded research programs.

3. The faculty members are nationally and internationally recognized among their peers.

4. The newly developed Clinical Pharmacy Ph.D. program is a bright spot in the program. • Dr. Johnson and her colleagues have a clearly stated vision for future progress, and are energetically pursuing opportunities for supporting their vision.

5. The research presentations of the graduate students were one of the highlights of our visit. The presentations were of very high quality, and these selected students were bright, well-spoken young scientists.

6. The graduates of the program are highly sought after by employers, particularly the pharmaceutical industry. There are very few graduate programs at the University of Florida that can rival the near-100% placement of the Pharmaceutics Ph.D. graduates in permanent positions, without additional post-doctoral training.

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Pharmaceutics Graduate Program Areas for Development (most of these areas are relevant for the “Core” pharmaceutics graduate program, and not the Clinical Pharmacy Ph.D. program). 1. The stipend for graduate students is inadequate and significantly below that of peer institutions, as well as significantly below that of other graduate programs within the UF College of Pharmacy. The inadequate stipend has several serious consequences. • There are very few domestic students in the program. • The graduate students are very concerned about their health insurance, which apparently covers very little and is of poor quality. The concern about out-of-pocket expenses for health care is exacerbated by the low stipend they receive. • The students gave the PRT the impression that, economically, they were barely managing, and one even spoke about considering a second job in order to support themselves. • The inequity in stipends both within the department and between departments are of significant concern to the PRT. This inequity is apparently allowed to exist even within individual laboratories. • In addition to having a low stipend for graduate students, there are students in program who are self-funded. This would not be allowed in a top-tier pharmaceutics graduate program. • The stipends are based on a 0.33 FTE appointment, which is out of line with top-tier pharmaceutics graduate programs, for which the standard is 0.5 FTE.

2. There is a lack of administrative infrastructure to support the graduate program. • There is no graduate program assistant (for example, a high-level secretary or professional administrative person) to assist the graduate students in navigating the University of Florida system. • The students expressed frustration regarding the lack of a central administrative figure to whom they could go with questions regarding such items as visa status, reimbursements, filing of graduate program documents, etc. • The students indicated that they did not wish to bother their faculty advisors with these administrative issues. • The PRT was later informed that there was such a person, but there was rapid turnover in the position, and the students expressed frustration that the individuals in that position were unresponsive to their requests.

3. Use of teaching assistant monies to support graduate students is of significant concern. The PRT agrees that it is of value that graduate students do some teaching activities while in their graduate program, but in the present case, these funds are being misused. • The graduate program uses teaching assistant funds to subsidize faculty research programs that may attract only modest external funding. If students are being placed in laboratories in which the research is not of high enough quality to obtain substantial external funding, the PRT has a concern that the students are not being trained in cutting-edge research. • A large proportion of students are on TA money for most of their time in program. This is out of line with top-tier Pharmaceutics graduate programs.

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• Students who are supported by research funding are apparently still required to teach. In some Universities, this would be considered by financial comptrollers to be out of compliance with auditing rules.

4. There are no program funds available for travel support to national meetings, including to the regional graduate student meetings. This support is dependent upon the individual investigator’s ability and willingness to fund their students’ travel.

5. There is no strategy for recruiting domestic students into the program. • However, the low stipend would render such a strategy futile, so the stipend issue must be resolved first.

6. The adjunct faculty roster is large, and there is no mechanism for review, no term of appointment, or formal requirements for continued appointment.

7. There is no formal effort for maintaining contact with the graduate program alumni. • Individual faculty members do maintain contact with their own graduates, but there is no departmental database.

8. With regards to the Clinical Pharmacy Ph.D. program, the evolution from a fellowship training mentality to a graduate training mentality is incomplete.

It should be noted that many of these issues are beyond the ability of the Graduate Program Coordinator or other faculty members to solve; they require action at the departmental or college levels.

Department of Pharmaceutics (Core) Areas for Development 1. There appears to be no administrative push or indeed, motivation, for increasing peer- reviewed external research funding. • Since the graduate students are supported by teaching assistant funds, this reduces the motivation for increasing research funding to support graduate students. • Since there is modest research funding, there are few post-doctoral scientists in the department. o The department head estimated that the graduate student to post-doctoral ratio was 6:1. o Lack of post-doctoral scientists deprives the graduate students of access to important scientific mentoring that can occur on a daily basis within an individual laboratory.

2. There is a lack of appreciation or desire to treat graduate students equitably within and between graduate programs, specifically with regards to stipend levels and teaching responsibilities.

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3. There has been very little progress made on issues raised in 1993 review. • There is a sense of complacency or lack of ambition with no indication that there is a strong desire for pursuing major improvement in the program. • There is a lack of a vision for the future of the graduate program and department.

4. The mechanism for development of departmental discretionary funds is currently of little value for department. • The department receives 7.5% of the indirect cost recovery (ICR) that it generates. • However, since the external research funds generated are modest, this mechanism is not of great utility.

College of Pharmacy Strengths 1. There are few programs at the University of Florida that can boast the national ranking of the College of Pharmacy Professional Pharm.D. Program (#9 in the U.S. in the most recent U.S. News and World Report rankings), not to mention the near 100% placement of its professional graduates in highly-paid positions (approximately $100,000 or more per year) immediately after graduation.

2. The College of Pharmacy faculty members are highly regarded among their peers.

College of Pharmacy Areas for Development 1. There is a lack of college oversight or even sense of responsibility for the inequities within and between graduate programs in terms of stipend floors, teaching activities, etc. 2. There appears to be a culture of modest expectations for the Pharmaceutics research and graduate program enterprise. 3. There is an apparent lack of interaction among graduate programs of the College of Pharmacy. 4. There does not appear to be transparency in budget allocations.

University of Florida Areas for Development 1. College of Pharmacy faculty ambitions have been undermined by lack of central support or recognition, despite their high rankings of the professional program and the outstanding record of placement of their graduates. • College of Pharmacy faculty undertook a fund-raising campaign to support the remodeling of research facilities; the re-modeled space was then transferred by Central Administration to the Medical School. • School resources have been strained by expansion of class sizes by 100% without University meeting its funding commitments to the College. The College received only 75% of the promised recurring costs.

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Recommendations 1. The stipend for the current and future Pharmaceutics graduate students should be immediately raised to the NIH floor for graduate research assistants, with appointments at 0.5 FTE.

2. The inequities in stipends within and between graduate programs should be eliminated. This may require leadership at the level of the College, or even the central administration, if the will to make this happen cannot be generated at the level of the departments.

3. A competent high-level administrative staff member, with specific responsibilities for the Pharmaceutics graduate program should be immediately named. • The performance evaluation of this staff member should be partially based upon the improvement of services to the graduate students.

4. Teaching responsibilities should be limited to a total of 2 semesters for each graduate student.

5. In order to train graduate students, faculty members must have the funds to support each student as a 0.5 FTE graduate research assistant (at the NIH floor for graduate research assistants) for three to four years. • The admissions process each year should be driven by how many faculty members can guarantee such research support. • Considering its current size, the graduate program should consider significantly diminishing the size of its entering class for several years, or even skip a year.

6. The College should take the lead in impressing upon the University central administration that the health insurance program for students and post-docs is grossly inadequate. • This inadequacy is particularly troubling considering that the University of Florida has a major Academic Health Center on campus.

7. Increase the number of domestic students in the Pharmaceutics graduate program. • Setting an adequate stipend is the first step. • A formal recruitment program should be undertaken by the College of Pharmacy in order to attract well-qualified students from Florida and the rest of the U.S. to all of the graduate programs in the College.

8. Set clear standards for the appointment of adjunct faculty in terms of contributions to program, and set terms of appointment with scheduled reviews for continuation.

9. Increase specific fund-raising activities for departmental support of student travel.

Response to Pharmaceutics Graduate Program Review

We very much appreciate the input provided by the Program Review Team (PRT). The report will be very helpful in guiding the faculty in deciding on the future structure of the Department’s Graduate Program.

Here are some specific responses:

Pharmaceutics Graduate Program Strengths (1-6) We appreciate the kind words, thank you very much.

Pharmaceutics Graduate Program Areas for Development

1. We fully agree that our current stipend level is very low and will increase the minimum pay in the future. Obviously, this will also result is a smaller number of graduate students that we will be able to support. We will look into the right balance of stipend and program size and make that decision jointly by faculty discussion and vote. As to the specific points raised: a. We will do more to encourage domestic students to join our program. We are hopeful that the Ph.D. Program in Clinical Sciences will facilitate this goal. b. We are also very concerned about the student’s health. However, health insurance issues are out of the control of the Department. We will raise this issue with the University administration. c. Although we believe that the student speaking about a second job is representative of our student population, we will increase the stipend level as mentioned above. d. The inequity of the stipend levels is not induced by the Department but rather by outside funding sources that provide fixed stipend levels. For example, the University has introduced recruitment stipend at very high levels ($25K) to recruit outstanding new students. Some foreign countries provide even higher stipends for their students. It is impossible for us to raise everybody to these externally determined levels so some inequity will always remain. We will try our best to minimize this. e. It turns out that after this semester we will no longer have any self-funded students. However, the Department does not feel that it is intrinsically wrong to admit self-funded students as long as they meet all academic requirements. Any Private School would be out of business otherwise, so, frankly, we cannot quite follow the recommendation of the PRT. f. The 0.33FTE is mandated by our University and not under the control of the Department. 2. We will review the internal infrastructure and design a more transparent administrative set-up. As was pointed out by the PRT, some recent turn-over in the Office may have contributed to the perceived confusion. 3. The Departmental Faculty strongly believes that teaching is an integral part of Graduate Education and should not be limited to two semesters only. There is a tremendous shortage of future educators in the Phamraceutical Sciences, and we feel it is our responsibility to prepare our Graduate Students for potential teaching careers as best as we can. 4. There seems to be a misconception that there is no travel support for graduate students. This year alone many students go overseas to present their work. As a matter of fact, I am not aware of a single student who was denied travel to a conference where he/she wanted to presen their research data. 5. As mentioned above, we are working at recruiting domestic students. The Clinical Science Program will help faciltitating this. 6. We continuously review the roster and encourage activities by our Adjunct Faculty. This group has been extremely supportive to the Department at absolutely no cost, and the Faculty is somewhat surprised that the PRT considers this as an issue. 7. This is a misconception. We stay in close contact with our alumni. The biannual Global Gator meeting is an event that brings together alumni from around the world. Furthermore, the College keeps a database will all contact information of our graduates. 8. It is not exactly clear what this point is referring to. However, there will be no more Fellows in the program in the future.

Department of Pharmaceutics (Core) Areas for Development

1. This is a clear misconception. Of course, there is a continuous encouragement for faculty to seek peer-reviewed external research funding and, of course, like most institutions, we can do better. We agree that post-docs can be helpful in mentoring graduate students. Most of our research groups have post-docs although the number can certainly be increased in the future. We will try to accomplish that. 2. The inequity was addressed earlier, this is almost always imposed externally. Within the department, we try to treat every student equally with all rights and duties. 3. We strongly disagree that there was no progress since 1993. The program size has more than tripled. We had the vision to focus on specific areas (PK/PD, Pharmacogenomics, Gene delivery, Herbal Medicine) and believe that we were correct in doing so. We provide a good education to our students with almost guaranteed employment opportunities and are a little surprised that is perceived as lack of vision. The future structure and philosophy of the program is in the hands of the faculty who all have built up very successful and productive academic programs with great future potential. 4. The IDC rate is not in the control of the Department.