Risk assessment of genotoxic impurities in marketed compounds administered over a short-term duration: Applications to oncology products and implications for impurity control limits

Organic Process Research and Development

Volumn 14, Issue 4, 2010, Pages 986-992

  Callis, Courtney M ^a   Bercu, Joel P ^a   Devries, Keith M ^a   Dow, Linda K ^a   Robbins, David K ^a   Varie, David L ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL METHOD; ANALYTICAL TECHNIQUES; ANTICANCER COMPOUNDS; AS LOW AS REASONABLY PRACTICABLE; ASSESSMENT APPROACHES; ASSESSMENT OF PROCESS; CHRONIC TOXICOLOGY; DRUG DEVELOPMENT; DRUG SUBSTANCES; GENOTOXIC IMPURITIES; HUMAN USE; IMPURITIES IN; IMPURITY CONTROL; INTERNATIONAL CONFERENCE ON HARMONIZATIONS; LIFE-SAVING MEDICINES; PATIENT SAFETY; PRODUCT QUALITY; REGULATORY GUIDANCE; SAFETY RISKS; STANDARD ASSUMPTIONS; TECHNICAL REQUIREMENT;

DRUG THERAPY; IMPURITIES; MEDICINE; RATING; TOXICITY;

RISK ASSESSMENT;

EID: 77955361727     PISSN: 10836160     EISSN: 1520586X     Source Type: Journal    
DOI: 10.1021/op1000226     Document Type: Article

References (16)

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