Statistical design and analysis of stability studies /
Shein-Chung Chow.
Boca Raton, Fla. : Chapman & Hall/CRC, c2007.
xvii, 330 p.
1584889055 (hardcover : alk. paper), 9781584889052 (hardcover : alk. paper)
More Details
Boca Raton, Fla. : Chapman & Hall/CRC, c2007.
1584889055 (hardcover : alk. paper)
9781584889052 (hardcover : alk. paper)
contents note
Accelerated testing -- Expiration dating period -- Stability designs -- Stability analysis with fixed batches -- Stability analysis with random batches -- Stability analysis with mixed effects model -- Stability analysis with discrete responses -- Stability analysis with multiple components -- Stability analysis with frozen drug products -- Stability testing for dissolution -- Current issues and recent development.
catalogue key
Includes bibliographical references (p. 307-322) and index.
A Look Inside
This item was reviewed in:
SciTech Book News, September 2007
To find out how to look for other reviews, please see our guides to finding book reviews in the Sciences or Social Sciences and Humanities.
Main Description
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.
Table of Contents
Accelerated Testing
Expiration Dating Period
Stability Designs
Stability Analysis with Fixed Batches
Stability Analysis with Random Batches
Stability Analysis with a Mixed Effects Model
Stability Analysis with Discrete Responses
Stability Analysis with Multiple Components
Stability Analysis with Frozen Drug Products
Stability Testing for Dissolution
Current Issues and Recent Developments
Table of Contents provided by Publisher. All Rights Reserved.

This information is provided by a service that aggregates data from review sources and other sources that are often consulted by libraries, and readers. The University does not edit this information and merely includes it as a convenience for users. It does not warrant that reviews are accurate. As with any review users should approach reviews critically and where deemed necessary should consult multiple review sources. Any concerns or questions about particular reviews should be directed to the reviewer and/or publisher.

  link to old catalogue

Report a problem