Specification of Drug Substances and Products

Specification of Drug Substances and Products Development and Validation of Analytical Methods

Hardback (17 Sep 2013)

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Publisher's Synopsis

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.

Book information

ISBN: 9780080983509
Publisher: Elsevier Science
Imprint: Elsevier
Pub date:
DEWEY: 615.19
DEWEY edition: 23
Language: English
Number of pages: 390
Weight: 970g
Height: 243mm
Width: 192mm
Spine width: 21mm