Guidelines and pharmacopoeial standards for pharmaceutical impurities: Overview and critical assessment

Regulatory Toxicology and Pharmacology

Volumn 63, Issue 2, 2012, Pages 298-312

  Snodin, David J ^a   McCrossen, Sean D ^b  

^a Xiphora Biopharma Consulting   (United Kingdom)

^b IEXA100 Consulting   (United Kingdom)

Author keywords

Analysis; Drug safety; Genotoxic; Guideline; ICH; Impurities; Pharmacopoeia; Qualification; Risk assessment; Toxicology; TTC

Indexed keywords

GENERIC DRUG; METAL; PROPOFOL; SOLVENT;

ARTICLE; DRUG CONTAMINATION; DRUG CONTROL; DRUG INDUSTRY; DRUG QUALITY; DRUG SAFETY; DRUG STRUCTURE; GENOTOXICITY; HUMAN; MEDICAL LITERATURE; MIXED CONCENTRATION DOSE LIMIT; NONHUMAN; POTENT IMPURITY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; RISK ASSESSMENT; STANDARD; STRUCTURE BASED QUALIFICATION THRESHOLD; TOXICOLOGICAL PARAMETERS; TOXICOLOGY;

CONSUMER PRODUCT SAFETY; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG CONTAMINATION; GUIDELINES AS TOPIC; MUTAGENS; PHARMACEUTICAL PREPARATIONS; PHARMACOPOEIAS AS TOPIC; RISK ASSESSMENT; STRUCTURE-ACTIVITY RELATIONSHIP;

EID: 84861387134     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2012.03.016     Document Type: Article

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