Regulation of genotoxic and carcinogenic impurities in drug substances and products

TrAC - Trends in Analytical Chemistry

Volumn 25, Issue 8, 2006, Pages 790-795

  McGovern, Timothy ^a   Jacobson Kram, David ^a  

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

Author keywords

Carcinogenic; Genotoxic; Impurity; Pharmaceutical; Regulation

Indexed keywords

BIOASSAY; IMPURITIES; REGULATORY COMPLIANCE; RISK ASSESSMENT; TOXICITY; TUMORS;

CARCINOGENIC IMPURITIES; DRUG SUBSTANCES; GENOTOXIC IMPURITIES; INTERNATIONAL GUIDELINES;

DRUG PRODUCTS;

CARCINOGEN;

ANALYTIC METHOD; ARTICLE; ASSAY; CARCINOGENICITY; DRUG IMPURITY; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; GENOTOXICITY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK ASSESSMENT; THEORETICAL STUDY;

EID: 33747890096     PISSN: 01659936     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.trac.2006.06.004     Document Type: Article

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