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Mutagenic Impurities

Strategies for Identification and Control

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Éditeur :

Wiley


Paru le : 2022-02-01



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Description

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. 
Pages
544 pages
Collection
n.c
Parution
2022-02-01
Marque
Wiley
EAN papier
9781119551218
EAN PDF
9781119551263
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
544
Taille du fichier
19978 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
223,61 €
EAN EPUB
9781119551256
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
544
Taille du fichier
33894 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
223,61 €

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