Genotoxic Impurities: Strategies for Identification and Control

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Product Description

This book examines genotoxic impurities and their impact on the pharmaceutical industry. �Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation.� The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. �In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.

Genotoxic Impurities: Strategies for Identification and Control Review

This book by Teasdale et al. is the best reference for the topic of identification and control of genotoxic impurities (GTIs) in pharmaceuticals, providing a comprehensive treatment of current industry and academic knowledge. Teasdale has assembled a world-class set of thought leaders and scientists, providing a reference book that should be required reading for anyone dealing with this topic. The history of guidance development and the development of the risk posed by genotoxic impurities is nicely tied to CM&C Quality perspectives. Additionally, the significant challenges involved in manufacturing and in developing analytical control strategies for the low level detection limits required for GTIs are nicely covered. This book will undoubtedly be an important reference as the International Conference on Harmonization develops a new guidance for genotoxic impurities in pharmaceuticals.

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