03063nam 2200457 450 991083103550332120230629215705.01-119-55126-91-119-55125-01-119-55124-2(MiAaPQ)EBC6881894(Au-PeEL)EBL6881894(CKB)21069156200041(EXLCZ)992106915620004120220923d2022 uy 0engurcnu||||||||txtrdacontentcrdamediacrrdacarrierMutagenic impurities strategies for identification and control /edited by Andrew TeasdaleHoboken, New Jersey :John Wiley & Sons, Incorporated,[2022]©20221 online resource (547 pages)Print version: Teasdale, Andrew Mutagenic Impurities Newark : John Wiley & Sons, Incorporated,c2022 9781119551218 Includes bibliographical references and index.Historical perspective on the development of the EMEA Guideline and subsequent ICH M7 Guideline -- ICH M7 -assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk -- Control strategies for mutagenic impurities -- Use of structure-activity relationship (SAR) evaluation as a critical tool in the evaluation of the genotoxic potential of impurities -- Evolution of quantitative structure-activity relationships ((Q)SAR) for mutagenicity -- Toxicity testing to understand the mutagenicity of pharmaceutical impurities -- Compound- and class-specific limits for common impurities in pharmaceuticals -- Genotoxic threshold mechanisms and points of departure -- Mutagenic impurities -assessment of fate and control options -- N-nitrosamines -- Conditions potentially leading to the formation of mutagenic impurities -- Strategic approaches to the chromatographic analysis of mutagenic impurities -- Analysis of mutagenic impurities by nuclear magnetic resonance (NMR) spectroscopy -- Addressing the complex problem of degradation-derived mutagenic impurities in drug substances and products."This book examines mutagenic impurities and their impact on the pharmaceutical industry, following the adoption of the ICH M7 guideline, while focusing on mutagenic impurities from both a toxicological and analytical perspective. The book serves as a primary reference point for anyone faced with addressing the issue of mutagenic impurities, providing readers with a definitive narrative of the guidelines and actual practical solutions to allow them to develop effective control measures"--Provided by publisher.DrugsTestingMutagenicity testingCongressesDrugsTesting.Mutagenicity testing576.542Teasdale AndrewMiAaPQMiAaPQMiAaPQBOOK9910831035503321Mutagenic impurities3965880UNINA