Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them.
Publisher: Elsevier Health Sciences
Number of pages: 390
Weight: 980 g
Dimensions: 235 x 191 x 20 mm
Edition: 2nd edition
"...a valuable addition to a pharmaceutical scientists' library....relevant and of interest to various "stake-holders" in the drug development arena, including chemists, analysts, and programme managers. I can recommend it."--Organic Process Research & Development Journal, Sep-14
"Its main role is to explain how to meet the most recent International Conference on Harmonization guidelines for drug development. The book is organized to offer a critical and comprehensive account of the approaches used to identify the key determinants of quality production that affect the safety, effectiveness, and marketability of a drug."--ProtoView.com, April 2014