Use of genotoxicity data to support clinical trials or positive genetox findings on a candidate pharmaceutical or impurity . . . . Now what?

International Journal of Toxicology

Volumn 24, Issue 3, 2005, Pages 129-134

  Jacobson Kram, David ^a   Jacobs, Abigail ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Carcinogenicity; Clinical trials; Genotoxic impurities; Genotoxicity; Pharmaceutical safety; Weight of evidence

Indexed keywords

ANIMAL CELL; CARCINOGENICITY; CELL TRANSFORMATION; CONFERENCE PAPER; EMBRYO; GENETIC TOXICOLOGY; GENOTOXICITY; NONHUMAN; SINGLE DRUG DOSE; SYRIAN HAMSTER;

ANIMALS; CLINICAL TRIALS; DRUG APPROVAL; DRUG CONTAMINATION; DRUG EVALUATION, PRECLINICAL; DRUGS, INVESTIGATIONAL; HUMANS; MUTAGENICITY TESTS; RISK ASSESSMENT;

MESOCRICETUS AURATUS;

EID: 22244450327     PISSN: 10915818     EISSN: None     Source Type: Journal    
DOI: 10.1080/10915810590952933     Document Type: Conference Paper

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