Книга Mutagenic Impurities - Strategies for Identification and Control Andrew Teasdale

Mutagenic Impurities - Strategies for Identification and Control

Автор: Andrew Teasdale
Език: Английски език
Корици: С твърди корици
Издател: John Wiley and Sons Ltd
Наличност: Външен склад
Изпращаме след 10-18 дни
226.43 442.86 лв
Learn to implement effective control measures for mutagenic impurities in pharmaceutical development...

Информация за книгата

Автор
Език
Английски език
Корици
Книга - С твърди корици
Издадена
2022
страници
544
EAN
9781119551218
ISBN
1119551218
Enbook ID
24989005
Издател
Теглоt
1204
Размери
262 x 183 x 40

Пълно описание

Learn to implement effective control measures for mutagenic impurities in pharmaceutical developmentIn 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 reagentsPerfect 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.

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