Assessment and acceptance of thresholds of genotoxic impurities in new drug substances: A regulatory perspective

International Journal of Pharmaceutical Medicine

Volumn 18, Issue 4, 2004, Pages 209-214

  Kasper, Peter ^a,b  

^a Fed Inst for Drugs/Med Devices   (Germany)

^b Federal Institute for Drugs and Medical Devices   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; DRUG ADDITIVE; EXCIPIENT;

ADVISORY COMMITTEE; ANALYTIC METHOD; AS LOW AS REASONABLY ACHIEVABLE PRINCIPLE; CONSENSUS DEVELOPMENT; DOSE CALCULATION; DRUG ANALYSIS; DRUG CONTROL; DRUG EXPOSURE; DRUG IMPURITY; DRUG INFORMATION; DRUG MANUFACTURE; DRUG SAFETY; EUROPE; GENOTOXICITY; HUMAN; IN VIVO STUDY; INTERNATIONAL CONFERENCE ON HARMONIZATION Q3A; MATHEMATICAL MODEL; MAXIMUM ALLOWABLE CONCENTRATION; NO EFFECT LEVEL UNCERTAINTY FACTOR APPROACH; NONHUMAN; POPULATION EXPOSURE; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; QUANTITATIVE RISK ASSESSMENT; REVIEW; RISK ASSESSMENT; SAFETY WORKING PARTY OF THE EUROPEAN COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE; THEORY; THRESHOLD OF TOXICOLOGICAL CONCERN; TIME; TOXICOLOGY; TREATMENT DURATION; TREATMENT INDICATION;

EID: 10844254687     PISSN: 13649027     EISSN: None     Source Type: Journal    
DOI: 10.1097/00124363-200418040-00002     Document Type: Review

References (16)

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