ICH guidelines: Inception, revision, and implications for drug development

Toxicological Sciences

Volumn 118, Issue 2, 2010, Pages 356-367

  Wang, Tao ^a   Jacobson Kram, David ^b   Pilaro, Anne M ^b   Lapadula, Daniel ^a   Jacobs, Abigail ^b   Brown, Paul ^b   Lipscomb, John ^c   McGuinn, William David ^b  

^a NOVARTIS PHARMA AG   (Switzerland)

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

^c U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOTECHNOLOGY; CARCINOGENICITY; DOSE RESPONSE; DRUG SAFETY; DRUG SCREENING; GENOTOXICITY; HUMAN; IMMUNOGENICITY; NONHUMAN; PRACTICE GUIDELINE; REPRODUCTIVE TOXICITY; TOXICITY TESTING;

ANIMALS; ANTINEOPLASTIC AGENTS; BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; DRUG DESIGN; DRUG DISCOVERY; GUIDELINES AS TOPIC; HUMANS; INTERNATIONAL AGENCIES; INTERNATIONAL COOPERATION; MUTAGENICITY TESTS; PHARMACEUTICAL PREPARATIONS; REPRODUCTION;

EID: 78549259732     PISSN: 10966080     EISSN: 10960929     Source Type: Journal    
DOI: 10.1093/toxsci/kfq286     Document Type: Article

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