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

Softcover

ISBN 10: 0081028245 ISBN 13: 9780081028247

Publisher: Elsevier, 2020

Synopsis

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.

The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.

About this title

About the Authors

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.

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.

From the Back Cover

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 goes beyond 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. This thoroughly revised second edition covers topics not covered―or not substantially covered―in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and government laboratories. This book thus provides readers with not only an understanding of industry best practices and future directions, but also an insight into how International Guidelines were developed and the rationale behind them.

Edition details

• Publisher: Elsevier
• Publication date: 2020
• Language: English
• ISBN 10: 0081028245
• ISBN 13: 9780081028247
• Binding: Paperback
• Edition number: 2
• Number of pages: 694
• Editor: Riley Christopher M., Rosanske Thomas W., Reid George L.