Original PDF Ebook – Specification of Drug Substances and Products2nd EditionDevelopment and Validation of Analytical Methods -9780081028247

Original PDF Ebook – Specification of Drug Substances and Products2nd EditionDevelopment and Validation of Analytical Methods -9780081028247

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._x000D_
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._x000D_
Presents a critical assessment of the application of ICH guidelines on method validation and specification setting_x000D_
Written by subject-matter experts involved in the development and application of the guidelines_x000D_
Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products_x000D_
Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction