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Volumn 67, Issue 105, 2002, Pages 37988-37998
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New drug and biological drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Final rule.
[No Author Info available]
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Author keywords
[No Author keywords available]
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Indexed keywords
BIOLOGICAL PRODUCT;
DRUG;
ANIMAL;
ANIMAL DISEASE;
ARTICLE;
BIOMEDICAL AND BEHAVIORAL RESEARCH;
DRUG APPROVAL;
DRUG LABELING;
DRUG SCREENING;
DRUG TOXICITY;
ETHICS;
FOOD AND DRUG ADMINISTRATION;
HUMAN;
HUMAN EXPERIMENT;
LEGAL APPROACH;
LEGAL ASPECT;
MEDICAL ETHICS;
METHODOLOGY;
TOXICITY TESTING;
UNITED STATES;
BIOMEDICAL AND BEHAVIORAL RESEARCH;
LEGAL APPROACH;
ANIMALS;
BIOLOGICAL PRODUCTS;
DRUG APPROVAL;
DRUG EVALUATION;
DRUG LABELING;
DRUG TOXICITY;
ETHICS, MEDICAL;
HUMAN EXPERIMENTATION;
HUMANS;
PHARMACEUTICAL PREPARATIONS;
TOXICITY TESTS;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
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EID: 0037205534
PISSN: 00976326
EISSN: None
Source Type: Journal
DOI: None Document Type: Article |
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Times cited : (205)
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References (0)
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