Acceptability of low levels of genotoxic impurities in new drug substances: Case reports

International Journal of Pharmaceutical Medicine

Volumn 18, Issue 4, 2004, Pages 215-220

  Leblanc, Bernard ^a   Charuel, Claude ^a   Ku, Warren ^b   Ogilvie, Ron ^c  

^a PFIZER INC   (United States)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^c PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALKYLATING AGENT; DRUG; DRUG ADDITIVE; DRUG INTERMEDIATE; DRUG METABOLITE; FUNCTIONAL GROUP; MUTAGENIC AGENT; REAGENT; UNCLASSIFIED DRUG;

ADVISORY COMMITTEE; ARTICLE; CONSENSUS DEVELOPMENT; DRUG ADMINISTRATION ROUTE; DRUG CONTROL; DRUG INDUSTRY; DRUG INFORMATION; DRUG INFORMATION ASSOCIATION; DRUG SYNTHESIS; EUROPE; EUROPEAN MEDICINES AGENCY; GENOTOXICITY; HUMAN; MAXIMUM ALLOWABLE CONCENTRATION; NONHUMAN; OCCUPATIONAL SAFETY; ORGANIZATION; PRIORITY JOURNAL; PUBLICATION; RISK ASSESSMENT; RISK MANAGEMENT; SAFETY WORKING PARTY OF THE EUROPEAN COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS; TIME; TOXICITY TESTING; TOXICOLOGY; TREATMENT DURATION; TREATMENT INDICATION; UNCERTAINTY;

EID: 10844271454     PISSN: 13649027     EISSN: None     Source Type: Journal    
DOI: 10.1097/00124363-200418040-00003     Document Type: Article

References (18)

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