{"product_id":"mutagenic-impurities-strategies-for-identification-and-control","title":"Mutagenic Impurities: Strategies for Identification and Control","description":"\u003cp\u003eBy Andrew Teasdale Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, 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. 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. 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. Readers will also benefit from the inclusion of: 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 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 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 Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control 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. Product Details Publisher ‏ : ‎ Wiley; 1st edition (February 15, 2022) Language ‏ : ‎ English Hardcover ‏ : ‎ 544 pages ISBN-10 ‏ : ‎ 1119551218 ISBN-13 ‏ : ‎ 978-1119551218 ISBN-13 ‏ : ‎ 9781119551218 eText ISBN: 9781119551256\u003c\/p\u003e","brand":"Toxicology","offers":[{"title":"Default Title","offer_id":48975946023086,"sku":null,"price":35.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0765\/8179\/8062\/files\/9781119551218.jpg?v=1788000785","url":"https:\/\/ebooksmedical.com\/products\/mutagenic-impurities-strategies-for-identification-and-control","provider":"Ebooks Medical","version":"1.0","type":"link"}