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Record Nr. |
UNINA9910831035503321 |
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Titolo |
Mutagenic impurities : strategies for identification and control / / edited by Andrew Teasdale |
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Pubbl/distr/stampa |
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Hoboken, New Jersey : , : John Wiley & Sons, Incorporated, , [2022] |
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©2022 |
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ISBN |
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1-119-55126-9 |
1-119-55125-0 |
1-119-55124-2 |
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Descrizione fisica |
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1 online resource (547 pages) |
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Disciplina |
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Soggetti |
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Drugs - Testing |
Mutagenicity testing |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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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. |
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Sommario/riassunto |
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"This book examines mutagenic impurities and their impact on the |
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