Food and drug administration requirements for testing and approval of new radiopharmaceuticals

Seminars in Nuclear Medicine

Volumn 40, Issue 5, 2010, Pages 364-384

  Harapanhalli, Ravi S ^a  

^a PAREXEL INTERNATIONAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

3' FLUOROTHYMIDINE F 18; AMMONIA N 13; BIOLOGICAL MARKER; COPPER 67; ENDOTOXIN; FLUORODEOXYGLUCOSE F 18; INDIUM 111; IODINE 123; IODINE 131; RADIOISOTOPE; RADIOPHARMACEUTICAL AGENT; SODIUM FLUORIDE F 18; TECHNETIUM 99M; UNCLASSIFIED DRUG; YTTRIUM 90;

ADVISORY COMMITTEE; DECISION TREE; DIAGNOSTIC IMAGING; DOSIMETRY; DRUG APPROVAL; DRUG CONTROL; DRUG DISCRIMINATION; DRUG EFFICACY; DRUG FORMULATION; DRUG INDICATION; DRUG LABELING; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; DRUG STABILITY; DRUG SURVEILLANCE PROGRAM; DRUG SYNTHESIS; FOOD AND DRUG ADMINISTRATION; GENETIC TOXICOLOGY; GOVERNMENT REGULATION; HUMAN; IMMUNOPHENOTYPING; IMMUNOTOXICITY; ISOTOPE LABELING; MEDICAL LITERATURE; NATIONAL HEALTH ORGANIZATION; NONHODGKIN LYMPHOMA; PHARMACY; POSITRON EMISSION TOMOGRAPHY; POSTMARKETING SURVEILLANCE; QUALITY CONTROL; RADIATION ABSORPTION; RADIATION DOSE; RADIATION EXPOSURE; REVIEW; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SHELF LIFE; TOXICITY TESTING; TOXICOKINETICS;

ANIMALS; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; GOVERNMENT REGULATION; HUMANS; RADIOPHARMACEUTICALS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77955677786     PISSN: 00012998     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.semnuclmed.2010.05.002     Document Type: Review

References (23)

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