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Specification of Drug Substances and Products

Development and Validation of Analytical Methods

2nd Edition - July 23, 2020

Editors: Christopher M. Riley, Thomas W. Rosanske, George L. Reid

Language: English
Paperback ISBN:
9 7 8 - 0 - 0 8 - 1 0 2 8 2 4 - 7
eBook ISBN:
9 7 8 - 0 - 0 8 - 1 0 2 8 2 5 - 4

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requireme… Read more

Specification of Drug Substances and Products

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Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.

The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.