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Bipolar Androgen Therapy (BAT) in Men with Prostate Cancer
Bipolar Androgen Therapy (BAT) in men with prostate cancer Samuel Denmeade, MD Professor of Oncology, Urology and Pharmacology The Johns Hopkins University School of Medicine, Baltimore, MD Presentation Overview • Androgen and Androgen Signaling 101 • Rationale For Bipolar Androgen Therapy (BAT) • Results from the RESTORE study testing BAT in Castration Resistant Prostate Cancer • The multi-center TRANSFORMER Trial • Future Directions • Results of BATMAN trial testing BAT as part of Intermittent Hormone Therapy strategy Testosterone Replacement Anabolic Steroids Trenbolone Acetate (Fina-Finaplix H pellets) High Dose Testosterone as Treatment for Prostate Cancer What Are Androgens? • Steroid hormone which can bind to Androgen Receptor – Testosterone, Dihydrotestosterone (DHT), DHEA, Androstenedione… • Sexual Differentiation – Needed to make a Male (Female is Default) • Primary Sex Characteristics: – Spermatogenesis – Accessory Sex Tissue Maintenance • Penis, Prostate... • Secondary Sex Characteristics: – Bone density – Muscle mass – Libido – Hair growth – Hematopoiesis What is a Steroid Hormone? Testosterone (T) Dihydrotestosterone (DHT) Estrogen How are Androgens Made? Androgen Receptor Signaling 101 Androgen Active Androgen Receptor (Testosterone) Androgen Receptor How Do Androgens Effect the Prostate Cell? NTD- Signaling Part DBD- DNA Binding Part LBD- Androgen Binding Part Cytoplasm Cell Nucleus Binds and activates genes: -Cell Growth -Cell Survival -Make prostate stuff like PSA, Acid Phosphatase, etc. DNA The Devilish Prostate • Physiologic -
Betamethasone Valerate Foam: a Look at the Clinical Data
Review: Clinical Trial Outcomes Betamethasone valerate foam: a look at the clinical data Clin. Invest. (2014) 4(3), 259–267 Topical corticosteroids and especially betamethasone valerate (BMV) have Avner Shemer1, Nicole Sakka1 & been used topically to relieve many inflammatory skin conditions such as Dov Tamarkin*2 psoriasis and atopic dermatitis. The vehicle used to deliver topical drugs 1Department of Dermatology, the Chaim Sheba Medical Center, Affiliated with the can influence the performance of these topical applications. BMV has Tel-Aviv University, Sackler School of Medicine, traditionally been available in creams, ointments, lotions and sprays. In Tel Hashomer, Israel the early 2000s, a topical hydroethanolic BMV foam became commercially 2Foamix Ltd., 2 Holzman Street, Weizmann available. Subsequently, alcohol-free emulsion- and petrolatum-based Science Park, Rehovot 76704, Israel foam formulations were also developed. This manuscript reviews the *Author for correspondence: Tel.: +972 52 457 5677 properties of BMV foams and clinical studies that have been conducted Fax: +972 8 853 1102 to assess their efficacy and safety as treatments for scalp and non-scalp [email protected] psoriasis, as well as other dermatological inflammatory conditions. Keywords: betamethasone valerate • foam • psoriasis • topical corticosteroids Topical corticosteroids have been ranked in four groups consisting of seven classes ranging from ultra-high potency preparations (class 1) to low-potency prepara- tions (class 7). Betamethasone valerate (BMV) is a mid-potency corticosteroid (class 3–5, depending on the dosage form), used topically to relieve inflammatory skin conditions. It is used as a treatment for psoriasis, atopic dermatitis and other corticosteroid-responsive dermatoses. The vehicle used to deliver topical drugs can influence the performance of these drugs. -
RELISTOR, INN: Methylnaltrexone Bromide
The European Medicines Agency Evaluation of Medicines for Human Use EMEA/CHMP/10906/2008 ASSESSMENT REPORT FOR RELISTOR International Nonproprietary Name: METHYLNALTREXONE BROMIDE Procedure No. EMEA/H/C/870 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 8613 E-mail: [email protected] http://www.emea.eu.int TABLE OF CONTENTS Page 1 BACKGROUND INFORMATION ON THE PROCEDURE......................................... 3 1.1 Submission of the dossier ...................................................................................................... 3 1.2 Steps taken for the assessment of the product ....................................................................... 3 2 SCIENTIFIC DISCUSSION............................................................................................... 4 2.1 Introduction............................................................................................................................ 4 2.2 Quality aspects....................................................................................................................... 5 2.3 Non-clinical aspects............................................................................................................... 7 2.4 Clinical aspects .................................................................................................................... 13 2.5 Pharmacovigilance...............................................................................................................41 -
(12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 De Juan Et Al
US 200601 10428A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 de Juan et al. (43) Pub. Date: May 25, 2006 (54) METHODS AND DEVICES FOR THE Publication Classification TREATMENT OF OCULAR CONDITIONS (51) Int. Cl. (76) Inventors: Eugene de Juan, LaCanada, CA (US); A6F 2/00 (2006.01) Signe E. Varner, Los Angeles, CA (52) U.S. Cl. .............................................................. 424/427 (US); Laurie R. Lawin, New Brighton, MN (US) (57) ABSTRACT Correspondence Address: Featured is a method for instilling one or more bioactive SCOTT PRIBNOW agents into ocular tissue within an eye of a patient for the Kagan Binder, PLLC treatment of an ocular condition, the method comprising Suite 200 concurrently using at least two of the following bioactive 221 Main Street North agent delivery methods (A)-(C): Stillwater, MN 55082 (US) (A) implanting a Sustained release delivery device com (21) Appl. No.: 11/175,850 prising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more (22) Filed: Jul. 5, 2005 bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more Related U.S. Application Data bioactive agents Subretinally; and (60) Provisional application No. 60/585,236, filed on Jul. (C) instilling (e.g., injecting or delivering by ocular ion 2, 2004. Provisional application No. 60/669,701, filed tophoresis) one or more bioactive agents into the Vit on Apr. 8, 2005. reous humor of the eye. Patent Application Publication May 25, 2006 Sheet 1 of 22 US 2006/0110428A1 R 2 2 C.6 Fig. -
Expression of Recombinant Human Androgen Receptor and Its Use for Screening Methods
Institut für Physiologie FML Weihenstephan Technische Universität München Expression of recombinant human androgen receptor and its use for screening methods Ellinor Rose Sigrid Bauer Vollständiger Abdruck der von der Fakultät Wissenschaftszentrum Weihenstephan für Ernährung, Landnutzung und Umwelt der Technischen Universität München zur Erlangung des akademischen Grades eines Doktors der Naturwissenschaften genehmigten Dissertation. Vorsitzender: Univ.-Prof. Dr. B. Hock Prüfer der Dissertation: Univ.-Prof. Dr. H. H. D. Meyer Univ.-Prof. Dr. H. Sauerwein (Rheinische Friedrich-Wilhelms-Universität Bonn) Die Dissertation wurde am 31.10.2002 bei der Technischen Universität München eingereicht und durch die Fakultät Wissenschaftszentrum Weihenstephan für Ernährung, Landnutzung und Umwelt am 03.12.2002 angenommen. Introduction Content 1. INTRODUCTION ..................................................................................................................................... 5 1.1. ENDOCRINE DISRUPTERS 5 1.2. ANDROGENS AND ANTIANDROGENS 7 1.2.1. DEFINITIONS 7 1.2.2. MODE OF ACTION 8 1.3. STRUCTURES OF ENDOCRINE DISRUPTERS 10 1.4. STRATEGIES FOR MONITORING ANDROGEN ACTIVE SUBSTANCES 13 1.4.1. IN VIVO METHODS 13 1.4.2. IN VITRO METHODS 15 1.5. OBJEKTIVE OF THE STUDIES 18 2. MATERIALS AND METHODS ................................................................................................................. 19 2.1. PREPARATION OF RECEPTORS 19 2.2. ASSAY SYSTEMS 19 2.2.1. IN SOLUTION AR ASSAY 19 2.2.2. IMMUNO-IMMOBILISED RECEPTOR ASSAY (IRA) 20 2.2.3. PR AND SHBG ASSAYS 21 2.2.4. DATA EVALUATION 21 2.3. ANALYTES 22 3. RESULTS AND DISCUSSION ................................................................................................................. 23 3.1. DEVELOPMENT OF NEW ASSAY SYSTEMS 23 3.1.1. BAR ASSAY 23 3.1.2. CLONING OF THE HUMAN AR AND PRODUCTION OF FUNCTIONAL PROTEIN 24 3.1.3. DEVELOPMENT OF A SCREENING ASSAY ON MICROTITRE PLATES (IRA) 25 3.2. -
Design and Synthesis of Cyclic Analogs of the Kappa Opioid Receptor Antagonist Arodyn
Design and synthesis of cyclic analogs of the kappa opioid receptor antagonist arodyn By © 2018 Solomon Aguta Gisemba Submitted to the graduate degree program in Medicinal Chemistry and the Graduate Faculty of the University of Kansas in partial fulfillment of the requirements for the degree of Doctor of Philosophy. Chair: Dr. Blake Peterson Co-Chair: Dr. Jane Aldrich Dr. Michael Rafferty Dr. Teruna Siahaan Dr. Thomas Tolbert Date Defended: 18 April 2018 The dissertation committee for Solomon Aguta Gisemba certifies that this is the approved version of the following dissertation: Design and synthesis of cyclic analogs of the kappa opioid receptor antagonist arodyn Chair: Dr. Blake Peterson Co-Chair: Dr. Jane Aldrich Date Approved: 10 June 2018 ii Abstract Opioid receptors are important therapeutic targets for mood disorders and pain. Kappa opioid receptor (KOR) antagonists have recently shown potential for treating drug addiction and 1,2,3 4 8 depression. Arodyn (Ac[Phe ,Arg ,D-Ala ]Dyn A(1-11)-NH2), an acetylated dynorphin A (Dyn A) analog, has demonstrated potent and selective KOR antagonism, but can be rapidly metabolized by proteases. Cyclization of arodyn could enhance metabolic stability and potentially stabilize the bioactive conformation to give potent and selective analogs. Accordingly, novel cyclization strategies utilizing ring closing metathesis (RCM) were pursued. However, side reactions involving olefin isomerization of O-allyl groups limited the scope of the RCM reactions, and their use to explore structure-activity relationships of aromatic residues. Here we developed synthetic methodology in a model dipeptide study to facilitate RCM involving Tyr(All) residues. Optimized conditions that included microwave heating and the use of isomerization suppressants were applied to the synthesis of cyclic arodyn analogs. -
Efficiency of Different Methods of Estrus Synchronization Followed by Fixed Time Artificial Insemination in Persian Downy Does
DOI: 10.21451/1984-3143-AR825 Anim. Reprod., v.14, n.2, p.413-417, Apr./Jun. 2017 Efficiency of different methods of estrus synchronization followed by fixed time artificial insemination in Persian downy does Majid Hashemi1, 2, 3, Mazaher Safdarian2 1Razi Vaccine and Serum Research Institute, Shiraz Branch, Agricultural Research, Education and Extension Organization (AREEO), Shiraz, Iran. 2Animal Science Research Department, Fars Agricultural and Natural Resource Research and Education Center, Agricultural Research, Education and Extension Organization (AREEO), Shiraz, Iran. Abstract estrus synchronization can play an important role for managing production system, allowing the density of For evaluating different methods of long term estrous mating and kidding and production of meat and milk synchronization followed by fixed time artificial during specific times of the year for strategic marketing insemination and to select the most efficient method, and other purposes (Baldassarre and Karatzas, 2004, during the breeding season 160 Persian downy does Zhao et al., 2010). In small ruminants, hormonal estrus were equally allocated to groups (n = 20/group). Estrus synchronization is achieved either by reducing the was synchronized using controlled internal drug release length of the luteal phase of the estrous cycle with devices alone (CIDR) or with equine chorionic prostaglandin F2α or by extending the cycle artificially gonadotropin (CIDR-eCG), intravaginal sponge with exogenous progesterone or more potent impregnated with 45 mg fluorgestone acetate alone progestagens (Hashemi et al., 2006, Abecia et al., (Sponge) or with eCG (Sponge-eCG), subcutaneous 2012). Progestogen administration is common and has auricular implant of 2 mg norgestomet alone (Implant) been used with or without accompanying treatments or with eCG (Implant-eCG) or two intramuscular such as gonadatropins or prostaglandin analogs. -
Anabolic-Androgenic Steroids in Horses: Natural Presence and Underlying Biomechanisms
ANABOLIC-ANDROGENIC STEROIDS IN HORSES: NATURAL PRESENCE AND UNDERLYING BIOMECHANISMS Anneleen Decloedt Dissertation submitted in the fulfilment of the requirements for the degree of Doctor of philosophy (PhD) in Veterinary Sciences, Faculty of Veterinary Medicine, Ghent University PROMOTER Prof. dr. ir. Lynn Vanhaecke Ghent University, Faculty of Veterinary Medicine Department of Veterinary Public Health and Food Safety Laboratory of Chemical Analysis MEMBERS OF THE READING COMMITTEE Prof. dr. James Scarth HFL Sport Science, Cambridgeshire, United-Kingdom Prof. dr. Peter Van Eenoo Ghent University, DoCoLab, Zwijnaarde, Belgium Prof. dr. Ann Van Soom Ghent University, Faculty of Veterinary Medicine, Merelbeke, Belgium MEMBERS OF THE EXAMINATION COMMITTEE Dr. Ludovic Bailly-Chouriberry Laboratoires des Courses Hippiques, Verrières-le-Buisson, France Dr. Leen Van Ginkel Wageningen University, RIKILT, Wageningen, The Netherlands Prof. dr. Myriam Hesta Ghent University, Faculty of Veterinary Medicine, Merelbeke, Belgium This work was funded by the Fédération Nationale des Courses Françaises (via the Laboratoire des Courses Hippiques) and executed at the Laboratory of Chemical Analysis (Faculty of Veterinary Medicine, Ghent University, Merelbeke). The author and the promoter give the authorisation to consult and to copy parts of this work for personal use only. Every other use is subject to the copyright laws. Permission to reproduce any material contained in this work should be obtained from the author. “The universe is full of magic, Just patiently waiting for our wits to grow sharper” TABLE OF CONTENTS TABLE OF CONTENTS Chapter I – General Introduction 1 1. Steroids 3 1.1 Chemical structure 1.2 (Steroid) hormones and their role in the endocrine system 1.3 Biosynthesis of steroid hormones 1.4 Anabolic-androgenic steroids (AAS) 1.5 Synthesis and absorption of the steroid precursor cholesterol 2. -
A Review of Unique Opioids and Their Conversions
A Review of Unique Opioids and Their Conversions Jacqueline Cleary, PharmD, BCACP Assistant Professor Albany College of Pharmacy and Health Sciences Adjunct Professor SAGE College of Nursing DISCLOSURES • Kaleo • Remitigate, LLC OBJECTIVES • Compare and contrast unique pharmacotherapy options for the treatment of chronic pain including: methadone, buprenoprhine, tapentadol, and tramadol • Select methadone, buprenorphine, tapentadol, or tramadol based on patient specific factors • Apply appropriate opioid conversion strategies to unique opioids • Understand opioid overdose risk surrounding opioid conversions and the use of unique opioids UNIQUE OPIOIDS METHADONE, BUPRENORPHINE, TRAMADOL, TAPENTADOL METHADONE My favorite drug because….? METHADONE- INDICATIONS • FDA labeled indications – (1) chronic pain (2) detoxification Oral soluble tablets for suspension NOT indicated for chronic pain treatment • Initial inpatient detoxification of opioids by a licensed trained provider with methadone and supportive care is appropriate • Methadone maintenance provider must have special credentialing and training as required by state Outpatient prescription must be for pain ONLY and say “for pain” on RX • Continuation of methadone maintenance from outside provider while patient is inpatient for another condition is appropriate http://cdn.atforum.com/wp-content/uploads/SAMHSA-2015-Guidelines-for-OTPs.pdf MECHANISM OF ACTION • Potent µ-opioid agonist • NMDA receptor antagonist • Norepinephrine reuptake inhibitor • Serotonin reuptake inhibitor ADVERSE EVENTS -
Methylnaltrexone Nonf
Methylnaltrexone Bromide Subcutaneous Injection and Tablets Criteria for Use May 2020 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives The following recommendations are based on medical evidence, clinician input, and expert opinion. The content of the document is dynamic and will be revised as new information becomes available. The purpose of this document is to assist practitioners in clinical decision-making, to standardize and improve the quality of patient care, and to promote cost- effective drug prescribing. THE CLINICIAN SHOULD USE THIS GUIDANCE AND INTERPRET IT IN THE CLINICAL CONTEXT OF THE INDIVIDUAL PATIENT. INDIVIDUAL CASES THAT ARE EXCEPTIONS TO THE EXCLUSION AND INCLUSION CRITERIA SHOULD BE ADJUDICATED AT THE LOCAL FACILITY ACCORDING TO THE POLICY AND PROCEDURES OF ITS P&T COMMITTEE AND PHARMACY SERVICES. The Product Information should be consulted for detailed prescribing information. Exclusion Criteria If ANY item below applies, the patient should NOT receive methylnaltrexone subcutaneous injections. Known or suspected mechanical gastrointestinal obstruction or other condition that may compromise drug action or cause bowel dysfunction (e.g., acute abdomen, ostomy, active diverticulitis, ischemic bowel, etc.) Placement of peritoneal catheter for chemotherapy or dialysis (not studied) End-stage renal impairment on dialysis (not studied) Use of methylnaltrexone solely for prevention of opioid-induced constipation or impaction (no supporting evidence). Use of methylnaltrexone for postoperative ileus (preliminary results showed inefficacy). Use of methylnaltrexone for constipation that is not opioid-related (not studied) Concomitant use of other opioid antagonists (potential for increased risks of additive effects and opioid withdrawal) Inclusion Criteria for Opioid-induced Constipation in Adults with Chronic Noncancer Pain All of the following criteria must be fulfilled. -
Pharmaceuticals and Endocrine Active Chemicals in Minnesota Lakes
Pharmaceuticals and Endocrine Active Chemicals in Minnesota Lakes May 2013 Authors Mark Ferrey Contributors/acknowledgements The MPCA is reducing printing and mailing costs This report contains the results of a study that by using the Internet to distribute reports and characterizes the presence of unregulated information to wider audience. Visit our website contaminants in Minnesota’s lakes. The study for more information. was made possible through funding by the MPCA reports are printed on 100 percent post- Minnesota Clean Water Fund and by funding by consumer recycled content paper manufactured the U.S. Environmental Protection Agency without chlorine or chlorine derivatives. (EPA), which facilitated the sampling of lakes for this study. The Minnesota Pollution Control Agency (MPCA) thanks the following for assistance and advice in designing and carrying out this study: Steve Heiskary, Pam Anderson, Dereck Richter, Lee Engel, Amy Garcia, Will Long, Jesse Anderson, Ben Larson, and Kelly O’Hara for the long hours of sampling for this study. Cynthia Tomey, Kirsten Anderson, and Richard Grace of Axys Analytical Labs for the expert help in developing the list of analytes for this study and logistics to make it a success. Minnesota Pollution Control Agency 520 Lafayette Road North | Saint Paul, MN 55155-4194 | www.pca.state.mn.us | 651-296-6300 Toll free 800-657-3864 | TTY 651-282-5332 This report is available in alternative formats upon request, and online at www.pca.state.mn.us. Document number: tdr-g1-16 Contents Contents ........................................................................................................................................... -
A10 Anabolic Steroids Hardcore Info
CONTENTS GENERAL INFORMATION 3 Anabolic steroids – What are they? 4 How do they Work? – Aromatisation 5 More molecules – More problems 6 The side effects of anabolic steroids 7 Women and anabolic steroids 8 Injecting steroids 9 Abscesses – Needle Exchanges 10 Intramuscular injection 11 Injection sites 12 Oral steroids – Cycles – Stacking 13 Diet 14 Where do steroids come from? Spotting a counterfeit 15 Drug Information – Drug dosage STEROIDS 16 Anadrol – Andriol 17 Anavar – Deca-Durabolin 18 Dynabolon – Durabolin – Dianabol 19 Esiclene – Equipoise 20 Primobolan Depot – Proviron – Primobolan orals – Pronobol 21 Sustanon – Stromba, Strombaject – Testosterone Cypionate Testosterone Enanthate 22 Testosterone Propionate – Testosterone Suspension 23 Trenbolone Acetate – Winstrol OTHER DRUGS 24 Aldactone – Arimidex 25 Clenbuterol – Cytomel 26 Ephedrine Hydrochloride – GHB 27 Growth Hormone 28 Insulin 30 Insulin-Like Growth Factor-1 – Human Chorionic Gonadotrophin 31 Tamoxifen – Nubain – Recreational Drugs 32 Steroids and the Law 34 Glossary ANABOLIC STEROIDS People use anabolic steroids for various reasons, some use them to build muscle for their job, others just want to look good and some use them to help them in sport or body building. Whatever the reason, care needs to be taken so that as little harm is done to the body as possible because despite having muscle building effects they also have serious side effects especially when used incorrectly. WHAT ARE THEY? Anabolic steroids are man made versions of the hormone testosterone. Testosterone is the chemical in men responsible for facial hair, deepening of the voice and sex organ development, basically the masculine things Steroids are in a man. used in medicine to treat anaemia, muscle weakness after These masculine effects surgery etc, vascular are called the androgenic disorders and effects of testosterone.