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Radionuclides and Radiopharmaceuticals for 2005

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NEWSLINE Radionuclides and Radiopharmaceuticals for 2005 he breakneck rate of change to which we have diagnosis of appendicitis in patients age 5 and over with become accustomed in the scientific world has not equivocal symptoms and signs. T been reflected in the number of changes in avail- Although PET agents such as 11C-carbon monoxide, able radionuclides and radiopharmaceuticals between my 11C-flumenazil, 11C-mespiperone, 11C-methionine, 11C- last compilation in 2003 (J Nucl Med. 2003;44[6]:27N– raclopride, 11C-acetate, 18F-fluorodopa, 13N-ammonia, and 31N) and the current lists. Economic and regulatory issues 15O-water are now being compounded under the state- have not kept pace with radiopharmaceutical science. regulated practice of medicine and pharmacy, these are Gone is radiolabeled hippuran (labeled with 123Ior not widely available outside of certain research institu- 131I), a stalwart of renal diagnosis since 1961, because of tions and so do not appear on the list. the excellent physical and biologic properties of 99mTc- I have added 2 radiopharmaceuticals classified as “de- mertiatide (MAG3). 99mTc-lidofenin has disappeared as a vices” for brachytherapy by the FDA: 90Y-microspheres hepatobiliary agent, leaving 99mTc-labeled disofenin and (for unresectable hepatocellular carcinoma) and 125I-3- mebrofenin on the market. iodo-4-hydroxybenzenesulfonate (for recurrent malignant 131I-tositumomab finally passed U.S. Food and Drug glioma). Administration (FDA) review as another labeled antibody A number of new radionuclides appear on this list, against lymphocyte antigen CD20 (as is 90Y-ibritumomab such as 7Be, 32Si, and 44Ti, produced by the U.S. Depart- tiuxetan) for the therapy of lymphoma. 99mTc- ment of Energy (DOE), as well as the radioisotopes of fanolesomab, an antibody directed against granulocyte plutonium, uranium, and thorium available from the antigen CD15, has been approved by the FDA for the (Continued on page 14N) TABLE 1 Commercially Available Radiopharmaceuticals, 2005 14C-urea 89Sr-strontium chloride 57Co-cyanocobalamin 99mTc-apcitide (GPIIa/IIIb)† 51Cr-sodium chromate 99mTc-arcitumomab (CEA)† 18F-sodium fluoride 99mTc-bicisate dihydrochloride (ECD)* 18F-fluorodeoxyglucose (FDG)* 99mTc-disofenin (DISIDA)* 67Ga-gallium citrate 99mTc-exametazime (HMPAO)* 111In-capromab pendetide (PMSA)† 99mTc-fanolesomab (CD15)† 111In-ibritumomab tiuxetan (CD20)† 99mTc-gluceptate 111In-indium chloride 99mTc-macroaggregated albumin (MAA)* 111In-indium oxyquinoline (oxine)* 99mTc-mebrofenin 111In-pentetate (DTPA)* 99mTc-medronate (MDP)* 111In-pentetreotide (SRS)† 99mTc-mertiatide (MAG3)* 123I-iobenguane (MIBG)* 99mTc-oxidronate (HDP)* 123I-sodium iodide 99mTc-pentetate (DTPA)* 125I-iodinated albumin (HSA)* 99mTc-sodium pertechnetate 125I-3-iodo-4-hydroxybenzenesulfonate** 99mTc-pyrophosphate (PYP)* 125I-sodium iothalamate 99mTc-red blood cells§ 131I-iobenguane 99mTc-sestamibi 131I-iodinated albumin 99mTc-succimer (DMSA)* 131I-sodium iodide 99mTc-sulfur colloid 131I-6-␤-iodomethyl-19-norcholesterol†† 99mTc-tetrofosmin 131I-tositumomab 201Tl-thallous chloride 32P-chromic phosphate (suspension) 133Xe-xenon gas 32P-sodium phosphate 90Y-ibritumomab tiuxetan (CD20)† 82Rb-rubidium chloride 90Y-microspheres** 153Sm-samarium lexidronam (EDTMP)* *Common chemical abbreviation. †Antigen or receptor with which interaction occurs. ††Investigational new drug (IND) approval with the University of Michigan required. §Red cells labeled with commercially available kit. **Classified as a medical device for brachytherapy by the U.S. Food and Drug Administration. Newsline 13N TABLE 2 Radionuclides Available in the United States, 2005 Radioisotopes Source Radioisotopes Source 225Ac/213Bi Alp, DOE 103Pd MURR, Nor, TCI, CNL 26Al CNL 109Pd MURR 241 NEWSLINE Am Aur, CNL 147Pm Aur, CNL 243Am DOE 149Pm MURR 41Ar TX, OR 210Po CNL 73As DOE 191Pt MURR 198Au MURR, OSU, TX 195mPt MURR, DOE-carrier free 133Ba DOE, INIS, Aur, CNL 240Pu DOE 7Be DOE, CNL 241Pu DOE 207Bi DOE, CNL 242Pu DOE 212Bi Alp 224Ra/212Pb/212Bi Alp 213Bi Alp 226Ra CNL 76Br WU 86Rb PE 77Br WU 186Re DOE, MURR, NOR 14C PE, Nor, CNL 188Re DOE, MURR 45Ca PE 105Rh MURR 109Cd DOE, PE, Aur, CNL 106Ru PE, CNL 139Ce CNL 33S CNL 141Ce PE 35S MURR, PE, CNL 252Cf DOE, Aur, CNL 122Sb MURR 36Cl PE 46Sc MURR, PE, TX 244Cm DOE, CNL 47Sc Alp 248Cm DOE 74Se CNL 57Co INIS, Nor, PE, Aur, CNL 75Se Aur, DOE, MURR 58Co CNL 76Se CNL 60Co DOE, INIS, PE, Nor, Aur, CNL 77Se CNL 51Cr MURR, PE, Nor 78Se CNL 137Cs INIS, Aur, CNL 80Se CNL 60Cu INIS, WU 82Se CNL 61Cu WU 32Si DOE 64Cu WU, Nor 153Sm MURR 67Cu Alp, DOE 113Sn PE 166Dy/166Ho MURR 117mSn DOE 55Fe Aur, DOE, PE, CNL 82Sr DOE, Nor, CNL 59Fe PE, CNL 85Sr DOE, PE, CNL 66Ga WU 89Sr DOE, CNL 67Ga BMS, Mal, Nor, CNL 90Sr DOE, Aur, CNL 68Ga CNL, TCI (from 68Ge generator) 160Tb MURR 153Gd PE, CNL, Aur 94mTc WU 68Ge DOE, INIS, PE, TCI, CNL 99Tc DOE, PE 3H PE, CNL 99mTc Mal 166Ho MURR 123mTe MURR, DOE 123I Alp, Am, Mal, Nor 125mTe MURR 124I WU 129mTe MURR 125I CAL-D, Nor, PE, TX, TCI, CNL 228Th Aur, CNL 129I PE, CNL 229Th DOE 131I Drax, INIS, Nor, PE, TCI, Mal, CNL 230Th DOE 111In Alp, Am, Mal, Nor, PE, CNL 44Ti DOE, CNL 114In PE 201Tl Am, BMS, Mal, Nor 192Ir Aur, DOE, MURR, Nor, WSU, CNL 234U DOE 42K MURR 235U DOE 85Kr Aur 236U CNL 177Lu Aur, DOE, INIS, MURR, Nor, PE 238U DOE 54Mn PE, Aur, CNL 188W/188Re DOE, CNL 99Mo Mal, Nor, TCI 133Xe Nor, Mal 22Na DOE, INIS, PE, Aur, CNL 86Y WU 24Na TX 88Y DOE, CNL 95Nb PE 90Y Aur, MURR, Nor, PE, CNL 63Ni Aur, DOE, PE 169Yb MURR, Aur 237Np CNL 65Zn DOE, MURR, PE, CNL 191Os MURR 68Zn CNL 32P MURR, Nor, PE, TCI, Mal, Aur, CNL 88Zr DOE 33P MURR, PE, CNL Alp ϭ AlphaMed (Acton, MA); Am ϭ Amersham Health (Princeton, NJ); Aur ϭ Auriga Medical of AEA Technology QSA, Inc. (Burlington, MA); BMS ϭ Bristol Myers Squibb (Princeton, NJ); CAL-D ϭ University of California-Davis (Davis, CA); CNL ϭ CNL Scientific Resources, Isotope Products Laboratories (Valencia, San Francisco, CA); DOE ϭ U.S. Department of Energy (Washington, DC); Drax ϭ Draximage Inc. (Quebec, Canada); INIS ϭ International Isotopes, Inc. (Idaho Falls, ID); Mal ϭ Mallinckrodt Corporation (St. Louis, MO); MURR ϭ University of Missouri Research Reactor (Columbia, MO); Nor ϭ MDS Nordion Corporation (Ottawa, ON, Canada); OR ϭ Oregon State University (Corvallis, OR); OSU ϭ Ohio State University (Columbus, OH); PE ϭ PerkinElmer Life and Analytical Sciences (Boston, MA); TCI ϭ TCI Medical, Inc. (Albuquerque, NM); TX ϭ Texas A&M University (College Station, TX); WSU ϭ Washington State University (Pullman, WA); WU ϭ Washington University (St. Louis, MO). (Continued on page 26N) 14N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 46 • No. 5 • May 2005 and Michael J. Welch, PhD, a professor of radiology and imaging/nuclear medicine on the cutting-edge of ever- chemistry and director of the department of radiology’s evolving modern medicine. research division at Washington University School of However, only Congress can reverse the budget cuts. Medicine (St. Louis, MO). We simply cannot afford to sit back and watch this We told the representatives from OMB and the Office situation become a reality. While we all cannot personally NEWSLINE of Science and Technology—and I repeated the concerns provide our perspectives on Capitol Hill, we can let our to Raymond L. Orbach, PhD, director of DOE’s Office of lawmakers know that these funding cuts are unacceptable. Science—that the future of effective therapies and Since SNM issued its call to action, nearly 2,700 mes- cutting-edge basic research in molecular imaging and sages (both e-mail and print) have been sent to Capitol nuclear medicine depends on DOE funding. SNM recog- Hill lawmakers denouncing the proposed budget cuts. nizes that there are many competing priorities in the FY Clearly, the impact on Congressional lawmakers would 2006 federal budget as well as serious fiscal challenges be exponentially greater if all of our 16,000 members and that the nation faces. However, without funding for Journal of Nuclear Medicine subscribers wrote to object to the suggested cuts. SNM has made this process very molecular/nuclear imaging programs, nuclear medicine easy, providing an online legislative action center that research will be severely curtailed, and millions of our supplies recommended e-mail text. The online action patients with cancer, brain diseases, and diseases of the center also automatically determines your representatives heart could be adversely affected. (based on your zip code) and provides their e-mail ad- Research and development carried out with DOE dresses. funding have made pioneering contributions that have On behalf of the society, I thank those who have formed the basis of molecular imaging/nuclear medicine already taken the time to send letters, and I appeal to as practiced today. These achievements have had a major others to take action and let your national representatives impact on the growth of molecular imaging/nuclear med- know you support molecular imaging/nuclear medicine icine and on the lead our nation enjoys in the field. The programs. Visit the SNM Web site at www.snm.org and list of accomplishments brought about by DOE funding is click on Government Relations for the link to the online long and includes the development of the Anger gamma legislative action center. The window of opportunity still camera, a primary tool; the 99mMo/99m Tc generator, the exists. Please do not procrastinate, as procrastination is workhorse; PET, the driving force of modern molecular the grave in which opportunity can get buried. SNM and imaging/nuclear medicine; 18F-FDG, which promotes the molecular imaging/nuclear medicine profession need metabolic imaging; and many other key radiopharmaceu- your help! ticals of diagnostic and therapeutic importance that are Mathew L. Thakur, PhD either in routine practice or promise to keep molecular President, SNM (Continued from page 14N) MS; and Wynn A.
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  • The Evolving Landscape of Therapeutic and Diagnostic Radiopharmaceuticals

    The Evolving Landscape of Therapeutic and Diagnostic Radiopharmaceuticals

    ARTICLE THE EVOLVING LANDSCAPE OF THERAPEUTIC AND DIAGNOSTIC RADIOPHARMACEUTICALS Therapeutic and diagnostic approaches involving the use of radiation and radioactive compounds have a long- standing history in the fields of science and medicine. Radiotherapy was first used in cancer treatments in 1896.1 Since then, the field of radiation has advanced to further understand how radioactive compounds interact with biological tissues and how they can be used in both diagnostic and therapeutic applications. Radiopharmaceuticals are compounds used for medicinal purposes that contain radioactive isotopes (also known as radionuclides) and can be diagnostic or therapeutic in nature, or both.2 They represent a unique category of pharmaceuticals due to their radioactive properties. As such, there are specific guidelines and regulations that impact and direct the study and use of these compounds. Radiopharmaceutical drug development has rapidly expanded over the last decade. Radiopharmaceuticals are widely used in the field of imaging for diagnosis, staging, and follow up; in the realm of therapeutics, their use has increased, most notably, in the area of oncology. In a recent webinar, experts from Medpace’s radiation oncology, imaging, regulatory, and operational teams discussed the growing space of radiopharmaceutical development with respect to their biological use and application, regulatory frameworks that govern their evaluation in support of approvals, operational manufacturing considerations, and associated imaging approaches. BIOLOGICAL MECHANISMS OF ACTION OF RADIONUCLIDES According to Dr. Jess Guarnaschelli, Medical Director, Radiation Oncology, the radioactivity of radionuclides can be employed for both diagnostic and therapeutic medical uses. While external beam ionizing radiation involves radiation emitted in the form of electromagnetic waves or particles, radiopharmaceuticals use radionuclides to deliver localized radiation to specific targets.
  • Pharmaceuticals Appendix

    Pharmaceuticals Appendix

    )&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ADAPALENE 106685-40-9 ABANOQUIL 90402-40-7 ADAPROLOL 101479-70-3 ABECARNIL 111841-85-1 ADEMETIONINE 17176-17-9 ABLUKAST 96566-25-5 ADENOSINE PHOSPHATE 61-19-8 ABUNIDAZOLE 91017-58-2 ADIBENDAN 100510-33-6 ACADESINE 2627-69-2 ADICILLIN 525-94-0 ACAMPROSATE 77337-76-9 ADIMOLOL 78459-19-5 ACAPRAZINE 55485-20-6 ADINAZOLAM 37115-32-5 ACARBOSE 56180-94-0 ADIPHENINE 64-95-9 ACEBROCHOL 514-50-1 ADIPIODONE 606-17-7 ACEBURIC ACID 26976-72-7 ADITEREN 56066-19-4 ACEBUTOLOL 37517-30-9 ADITOPRIME 56066-63-8 ACECAINIDE 32795-44-1 ADOSOPINE 88124-26-9 ACECARBROMAL 77-66-7 ADOZELESIN 110314-48-2 ACECLIDINE 827-61-2 ADRAFINIL 63547-13-7 ACECLOFENAC 89796-99-6 ADRENALONE 99-45-6 ACEDAPSONE 77-46-3 AFALANINE 2901-75-9 ACEDIASULFONE SODIUM 127-60-6 AFLOQUALONE 56287-74-2 ACEDOBEN 556-08-1 AFUROLOL 65776-67-2 ACEFLURANOL 80595-73-9 AGANODINE 86696-87-9 ACEFURTIAMINE 10072-48-7 AKLOMIDE 3011-89-0 ACEFYLLINE CLOFIBROL 70788-27-1