Regulating impurities in pharmaceutical products: A tolerability of risk approach?

Expert Review of Clinical Pharmacology

Volumn 1, Issue 2, 2008, Pages 241-250

  Bouder, Frederic ^a  

^a KING'S COLLEGE LONDON   (United Kingdom)

Author keywords

ALARP; Genotoxic impurities; Regulation; Tolerability of risk; ToR

Indexed keywords

AFLATOXIN; ANTIINFECTIVE AGENT; ANTIRETROVIRUS AGENT; CARCINOGEN; DRUG; MESYLIC ACID ETHYL ESTER; NELFINAVIR; ROFECOXIB;

ARTICLE; CANCER RISK; CARCINOGENICITY; CONCEPTUAL FRAMEWORK; DECISION MAKING; DRUG CONTAMINATION; DRUG DETERMINATION; DRUG EXPOSURE; DRUG INDICATION; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG PACKAGING; DRUG POTENCY; DRUG PURITY; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEASIBILITY STUDY; FOOD CONTAMINATION; GENOTOXICITY; GOVERNMENT REGULATION; HEALTH HAZARD; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MATHEMATICAL MODEL; MORTALITY; MUTAGENICITY; NONHUMAN; OCCUPATIONAL EXPOSURE; OCCUPATIONAL HAZARD; PHARMACEUTICAL CARE; POLLUTION; PRACTICE GUIDELINE; PREGNANT WOMAN; QUALITY CONTROL; RECOMMENDED DRUG DOSE; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; RISK REDUCTION; STANDARDIZATION; UNITED KINGDOM;

EID: 49249125564     PISSN: 17512433     EISSN: None     Source Type: Journal    
DOI: 10.1586/17512433.1.2.241     Document Type: Article

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