Statistical Design and Analysis of Stability Studies (Chapman & Hall/CRC Biostatistics Series) - Softcover

Chow, Shein-Chung

Softcover

ISBN 10: 0367577682 ISBN 13: 9780367577681

Publisher: Routledge, 2020

Synopsis

The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies.

After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies.

To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.

About this title

About the Author

Shein-Chung Chow

Edition details

• Publisher: Routledge
• Publication date: 2020
• ISBN 10: 0367577682
• ISBN 13: 9780367577681
• Binding: Paperback
• Language: English
• Edition number: 1
• Number of pages: 348