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

Name: Specification of Drug Substances and Products: Development and Validation of Analytical Methods
Brand: Elsevier
SKU: 9780080983509
Price: 8506.0 INR
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by Christopher M. Riley

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ISBN13: 9780080983509
Binding: Hardcover
Subject: N/A
Publisher: Elsevier
Publisher Imprint: Elsevier
Publication Date: October 23, 2013
Pages: 390
Original Price: GBP 83.0
Language: English
Edition: N/A
Item Weight: 975 grams
BISAC Subject(s): Life Sciences / Biochemistry, Biotechnology, and Chemistry / Analytic

About The Book

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.

About The Author

Riley, Christopher M.: -

Dr. Christopher Riley is the President of Riley and Rabel Consulting Services. He received a bachelor's degree in Pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, UK. He taught Pharmaceutical Chemistry, at the Universities of Florida (1983-6) and the University of Kansas (1986-94), and was a Vice President at DuPont Merck (1994-2001) and ALZA (a division of J&J) (2001-7). He has coauthored more than 140 book chapters and papers in peer-reviewed journals, as well as 5 books. He has extensive experience in CMC regulatory affairs and the development of all types of dosage forms.

Rosanske, Thomas W.: - Former Director of Business Development at Acceleration Laboratory Services, Incorporated. He has previously held scientific and senior management positions at The Upjohn Company, Marion Laboratories, Marion Merrell Dow, Hoechst Marion Roussel, Quintiles, Eli Lilly, Beckloff Associates, and PPD. He currently serves on a Small Molecule USP Expert Committee.

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