Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control

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.