Unique/major human metabolites: Why, how, and when to test for safety in animals

Drug Metabolism Reviews

Volumn 40, Issue 3, 2008, Pages 447-463

  Luffer Atlas, Debra ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

FDA draft guidance; Major human metabolites; Metabolite safety testing; Unique human metabolites

Indexed keywords

DRUG METABOLITE;

DRUG INDUSTRY; DRUG METABOLISM; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; PRACTICE GUIDELINE; REVIEW;

ANIMALS; BIOTRANSFORMATION; CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; DRUGS, INVESTIGATIONAL; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; RISK ASSESSMENT; TOXICITY TESTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 47649088457     PISSN: 03602532     EISSN: 10979883     Source Type: Journal    
DOI: 10.1080/03602530802186561     Document Type: Review

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