Journal
ORGANIC PROCESS RESEARCH & DEVELOPMENT
Volume 17, Issue 2, Pages 221-230Publisher
AMER CHEMICAL SOC
DOI: 10.1021/op300268u
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The control of genotoxic impurities (GTIs) is a crucial activity that is performed for any new chemical entity intended for clinical use. A key element of this is the quality risk assessment. This article seeks to examine the primary components of such a strategy, focusing specifically on the effective use of in silica assessment tools to augment this process, in particular the calculation of theoretical purge factors based on the physicochemical properties of a specific GTI and its interrelationship to the process.
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