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

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• 作者：Andrew Teasdale ; David Elder ; Sou-Jen Chang ; Sophie Wang ; Richard Thompson ; Nancy Benz ; Ignacio H. Sanchez Flores
• 刊名：Organic Process Research & Development
• 出版年：2013
• 出版时间：February 15, 2013
• 年：2013
• 卷：17
• 期：2
• 页码：221-230
• 全文大小：300K
• 年卷期：v.17,no.2(February 15, 2013)
• ISSN：1520-586X

文摘

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 silico 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.