Risk assessment of genotoxic impurities in new chemical entities: Strategies to demonstrate control

Organic Process Research and Development

Volumn 17, Issue 2, 2013, Pages 221-230

  Teasdale, Andrew ^a   Elder, David ^b   Chang, Sou Jen ^c   Wang, Sophie ^d   Thompson, Richard ^e   Benz, Nancy ^c   Sanchez Flores, Ignacio H ^f  

^a ASTRAZENECA   (United Kingdom)

^b GLAXOSMITHKLINE   (United Kingdom)

^c ABBOTT LABORATORIES   (United States)

^d AMGEN INC   (United States)

^e Boehringer Ingelheim   (United States)

^f TAKEDA PHARMACEUTICALS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ASSESSMENT TOOL; CLINICAL USE; GENOTOXIC IMPURITIES; IN-SILICO; KEY ELEMENTS; NEW CHEMICAL ENTITIES; PHYSICOCHEMICAL PROPERTY; QUALITY RISKS;

RISK ASSESSMENT;

EID: 84874104638     PISSN: 10836160     EISSN: 1520586X     Source Type: Journal    
DOI: 10.1021/op300268u     Document Type: Article

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