Specification of Drug Substances and Products
Development and Validation of Analytical Methods
- Christopher M. Riley, President of Riley and Rabel Consulting Services, Maryville, MO, USA
- Thomas W. Rosanske, Director of Business Development at Acceleration Laboratory Services, Inc., Lee's Summit, MO, USA
- Shelley R. Rabel Riley, Assistant Professor of Chemistry in the Department of Natural Sciences at Northwest Missouri State University, Maryville, USA
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.
For undergraduate pharmacy students and chemistry students; postgraduate students and faculty in analytical chemistry, pharmaceutical chemistry, pharmaceutical analysis, pharmaceutics and medicinal chemistry; analytical scientists in government, pharmaceutical industry and biotechnology industry and regulatory agencies.