Specification of Drug Substances and Products is popular PDF and ePub book, written by Christopher M. Riley in 2020-07-23, it is a fantastic choice for those who relish reading online the Science genre. Let's immerse ourselves in this engaging Science book by exploring the summary and details provided below. Remember, Specification of Drug Substances and Products can be Read Online from any device for your convenience.
Specification of Drug Substances and Products Book PDF Summary
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. Presents a critical assessment of the application of ICH guidelines on method validation and specification setting Written by subject-matter experts involved in the development and application of the guidelines Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
Detail Book of Specification of Drug Substances and Products PDF
- Author : Christopher M. Riley
- Release : 23 July 2020
- Publisher : Elsevier
- ISBN : 9780081028254
- Genre : Science
- Total Page : 696 pages
- Language : English
- PDF File Size : 14,7 Mb
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