Specification of Drug Substances and Products: Development and Validation of Analytical Methods (Hardcover)

Specification of Drug Substances and Products: Development and Validation of Analytical Methods By Christopher M. Riley (Editor), Thomas W. Rosanske (Editor) Cover Image
$119.95

Description


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.



Product Details
ISBN: 9780080983509
ISBN-10: 0080983502
Publisher: Elsevier
Publication Date: October 23rd, 2013
Pages: 390
Language: English