Specification of Drug Substances and Products

ISBN: 978Show contact number
Author: Christopher M.R. Thomas W. Shelley R.
Pub: Elsevier
Year: 2014
Stock: 1

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.

Note: The book is an old stock, please expect few defects. Kindly chat to request to see the condition of the book.