{"product_id":"mutagenic-impurities-strategies-for-identification-and-control","title":"Mutagenic Impurities","description":"\u003cp\u003e\u003cb\u003eLearn to implement effective control measures for mutagenic impurities in pharmaceutical development \u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eIn \u003ci\u003eMutagenic Impurities: Strategies for Identification and Control\u003c\/i\u003e, 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. \u003c\/p\u003e \u003cp\u003eThe 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. \u003c\/p\u003e \u003cp\u003eThe 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. \u003c\/p\u003e \u003cp\u003eReaders will also benefit from the inclusion of: \u003c\/p\u003e \u003cul\u003e\n\u003cli\u003eA 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 \u003c\/li\u003e\n\u003cli\u003eAn 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 \u003c\/li\u003e\n\u003cli\u003eA discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents \u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003ePerfect for chemists, analysts, and regulatory professionals, \u003ci\u003eMutagenic Impurities: Strategies for Identification and Control\u003c\/i\u003e 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. \u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":54081381237080,"sku":null,"price":231.82,"currency_code":"EUR","in_stock":true}],"url":"https:\/\/agendabookshop.com\/products\/mutagenic-impurities-strategies-for-identification-and-control","provider":"Agenda Bookshop","version":"1.0","type":"link"}