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9781584889052

Statistical Design and Analysis of Stability Studies

by ;
  • ISBN13:

    9781584889052

  • ISBN10:

    1584889055

  • Edition: 1st
  • Format: Hardcover
  • Copyright: 2007-05-30
  • Publisher: Chapman & Hall/

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Summary

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

Introduction
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
Appendices
References
Index
Table of Contents provided by Publisher. All Rights Reserved.

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