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

被引：95

作者：

Teasdale, Andrew ^{[1
]}

Elder, David ^{[2
]}

Chang, Sou-Jen ^{[3
]}

Wang, Sophie ^{[4
]}

Thompson, Richard ^{[5
]}

Benz, Nancy ^{[6
]}

Flores, Ignacio H. Sanchez ^{[7
]}

机构：

[1] AstraZeneca, Macclesfield SK10 2NX, Cheshire, England

[2] GlaxoSmithKline, Ware SG12 0DP, Herts, England

[3] Abbott Labs, Abbott Pk, IL 60064 USA

[4] Amgen Inc, Thousand Oaks, CA 91320 USA

[5] Ben Venue Labs Inc, Boehringer Ingelheim, Bedford, OH 44146 USA

[6] Abbott Labs, Dept R45T, Abbott Pk, IL 60064 USA

[7] Takeda Global Res & Dev Ctr Inc, Deerfield, IL 60015 USA

来源：

ORGANIC PROCESS RESEARCH & DEVELOPMENT | 2013年 / 17卷 / 02期

关键词：

D O I：

10.1021/op300268u

中图分类号：

O69 [应用化学];

学科分类号：

081704 ;

摘要：

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.

引用

页码：221 / 230

页数：10

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