Mutagenic impurities : strategies for identification and control / / edited by Andrew Teasdale

• Pubblicazione: Hoboken, New Jersey : , : John Wiley & Sons, Incorporated, , [2022]; ©2022
• Descrizione fisica: 1 online resource (547 pages)
• Disciplina: 576.542
• Soggetto topico: Drugs - Testing; Mutagenicity testing
• Persona (resp. second.): TeasdaleAndrew
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: 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.
• 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 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"--
• Titolo autorizzato: Mutagenic impurities
• ISBN: 1-119-55126-9; 1-119-55125-0; 1-119-55124-2
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910831035503321
• Lo trovi qui: Univ. Federico II