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About Mutagenic Impurities: Strategies for Identification and Control
DESCRIPTION<p><b>Learn to implement effective control measures for mutagenic impurities in pharmaceutical development </b></p><p>In <i>Mutagenic Impurities: Strategies for Identification and Control</i>, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. </p><p>The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. </p><p>The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. </p><p>Readers will also benefit from the inclusion of: </p><ul><li>A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline </li><li>An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities </li><li>A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents </li></ul><p>Perfect for chemists, analysts, and regulatory professionals, <i>Mutagenic Impurities: Strategies for Identification and Control</i> will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control. </p>
Detailed Information
| Author: | Andrew Teasdale |
|---|---|
| Publication Year: | 2022 |
| ISBN: | 1119551218 |
| Pages: | 544 |
| Language: | other |
| File Size: | 15.5204 |
| Format: | |
| Price: | FREE |
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