Mutagenic Impurities
Strategies for Identification and Control
Andrew Teasdale, Andrew Teasdale
- English
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Mutagenic Impurities
Strategies for Identification and Control
Andrew Teasdale, Andrew Teasdale
Informazioni sul libro
Learn to implement effective control measures for mutagenic impurities in pharmaceutical development
In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale deliversa thorough examinationof mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective.
The editor has created a primary reference for any professional or studentstudying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters onthe purge tool for risk assessment.
The book incorporates a discussion of N-Nitrosamines which was arguably the largestmutagenic impurityissue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugsresulting from N-Nitrosaminecontamination.
Readers will also benefit from the inclusion of:
- A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline
- An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities
- A discussion ofa toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential ofcommon synthetic reagents
Perfect forchemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries oftoxicologists and clinical safety scientists seeking a one-stop referenceon the subject of mutagenicimpurity identification and control.