Specification of Drug Substances and Products : Elsevier : 9780080983509 : 0080983502 : 17 Sep 2013 : 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. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD)Critical assessment of the application of ICH guid