Mutagenic impurities strategies for identification and control
"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 wi...
| Otros Autores: | |
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| Formato: | Libro electrónico |
| Idioma: | Inglés |
| Publicado: |
Hoboken, NJ :
Wiley
2022.
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| Colección: | Wiley ebooks.
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| Acceso en línea: | Conectar con la versión electrónica |
| Ver en Universidad de Navarra: | https://innopac.unav.es/record=b46146386*spi |
Tabla de Contenidos:
- 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.
