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Mutagenic Impurities – Strategies for Identification and Control de A Teasdale

Mutagenic Impurities – Strategies for Identification and Control

Autor A Teasdale
en Limba Engleză Hardback – 7 apr 2022
Das zentrale Thema dieses Buchs sind mutagene Verunreinigungen und deren Auswirkungen auf die pharmazeutische Industrie. Die aktuelle Ausgabe umfasst neue Kapitel und aktualisierte Inhalte, in denen die Anwendung der Richtlinie ICH M7 berücksichtigt wird. Gleichzeitig liegt der Schwerpunkt wie zuvor auf dem Thema mutagene Verunreinigungen aus toxikologischer und analytischer Sicht. Auch die neue Ausgabe ist eine wichtige Quelle für alle, die sich mit dem Problem mutagener Verunreinigungen befassen. Sie enthält eine klare Darstellung der Richtlinien und konkrete praktische Lösungen, die es den Leserinnen und Lesern ermöglichen, wirksame Kontrollmaßnahmen zu entwickeln.
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Specificații

ISBN-13: 9781119551218
ISBN-10: 1119551218
Pagini: 544
Dimensiuni: 183 x 257 x 39 mm
Greutate: 1.17 kg
Ediția:2nd Edition
Editura: Wiley
Locul publicării:Hoboken, United States

Descriere

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. 

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