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[null,null,"Titolo",null,"Mutagenic impurities : strategies for identification and control / / edited by Andrew Teasdale"]
[null,null,"Pubbl/distr/stampa",null,"Hoboken, New Jersey : , : John Wiley & Sons, Incorporated, , [2022]"]
[{"$nulls":4},"©2022"]
[null,null,"ISBN",null,"1-119-55126-9"]
[{"$nulls":4},"1-119-55125-0"]
[{"$nulls":4},"1-119-55124-2"]
[null,null,"Descrizione fisica",null,"1 online resource (547 pages)"]
[null,null,"Disciplina",null,"576.542"]
[null,null,"Soggetti",null,"Drugs - Testing"]
[{"$nulls":4},"Mutagenicity testing"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"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."]
[null,null,null,"Sommario/riassunto","\"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 "]
[{"$nulls":4},"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\"--"]