Specification of Drug Substances and Products
Development and Validation of Analytical Methods
||Riley, Christopher M.|
Rosanske, Thomas W.
Riley, Shelley R. Rabel
|Publication Date:||Oct 2013|
| Publisher:||Elsevier Science & Technology Books|
| Book Format:||Hardback|
|List Price:||USD $119.95|
| Book 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...