Pharmaceutical Industry Practices on Genotoxic Impurities (Hardcover)

A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text: Explores the safety, quality, and regulatory aspects of GTIs Provides an overview of the latest FDA and EMEA guidelines Explains the how and why of various GTI control tactics and practices Describes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testing Includes real-life examples of GTI control in drug substance and drug product development processes Containing case studies from large and small pharmaceutical firms in multiple geographical regions, Pharmaceutical Industry Practices on Genotoxic Impurities supplies an overview of-and a current framework for-GTI control in the pharmaceutical industry, demonstrating how proper management of GTIs can occur with the appropriate guidance, a firm grasp of the practical implications, and effective information sharing between disciplines.

General

Imprint:	Crc Press
Country of origin:	United States
Series:	Chromatographic Science Series
Release date:	August 2014
First published:	2014
Editors:	Heewon Lee
Dimensions:	234 x 156 x 34mm (L x W x T)
Format:	Hardcover
Pages:	536
ISBN-13:	978-1-4398-7420-2
Categories:	Books > Medicine > Pre-clinical medicine: basic sciences > Medical genetics Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
LSN:	1-4398-7420-4
Barcode:	9781439874202

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