Strategies for the Evaluation of Genotoxic Impurity Risk
Author:
Publisher
John Wiley & Sons, Inc.
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/9780470929377.ch9/fullpdf
Reference25 articles.
1. Toxicological overview of impurities in pharmaceutical products;Jacobson-Cram;Advanced Drug Delivery Reviews,2007
2. The application of structure based assessment to support safety and chemistry diligence to manage genotoxic impurities in actives pharmaceutical ingredients during drug development;Dobo;Regulatory Toxicology and Pharmacology,2006
3. Approaches to assessment, testing decisions and analytical determination of genotoxic impurities in drug substances;Pierson;Organic Process Research and Development,2009
4. Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process;Lui;Journal of Pharmaceutical and Biomedical Analysis,2009
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3. Comparative evaluation of 11 in silico models for the prediction of small molecule mutagenicity: role of steric hindrance and electron-withdrawing groups;Toxicology Mechanisms and Methods;2016-11-04
4. Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control;Organic Process Research & Development;2013-02-04
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