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Mutagenic Impurities: Strategies for Identification and Control by Andrew Teasda

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ISBN-13
9781119551218
Book Title
Mutagenic Impurities
ISBN
9781119551218
Publication Year
2021
Type
Textbook
Format
Hardcover
Language
English
Publication Name
Mutagenic Impurities: Strategies for Identification and Control
Author
Andrew Teasdale
Publisher
John Wiley & Sons AND Sons LTD
Subject
Biology
Item Weight
666g
Number of Pages
560 Pages

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Product Information

Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of 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 student studying 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 on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. 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 of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.

Product Identifiers

Publisher
John Wiley & Sons AND Sons LTD
ISBN-13
9781119551218
eBay Product ID (ePID)
27049955484

Product Key Features

Author
Andrew Teasdale
Publication Name
Mutagenic Impurities: Strategies for Identification and Control
Format
Hardcover
Language
English
Subject
Biology
Publication Year
2021
Type
Textbook
Number of Pages
560 Pages

Dimensions

Item Weight
666g

Additional Product Features

Title_Author
Andrew Teasdale
Country/Region of Manufacture
United States

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