Statistical Design and Analysis of Stability Studies

Front Cover
CRC Press, May 30, 2007 - Mathematics - 331 pages
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.
 

What people are saying - Write a review

User Review - Flag as inappropriate

Its very nice book

Contents

Chapter 1 Introduction
1
Chapter 2 Accelerated Testing
25
Chapter 3 Expiration Dating Period
53
Chapter 4 Stability Designs
73
Chapter 5 Stability Analysis with Fixed Batches
99
Chapter 6 Stability Analysis with Random Batches
125
Chapter 7 Stability Analysis with a Mixed Effects Model
165
Chapter 8 Stability Analysis with Discrete Responses
175
Chapter 10 Stability Analysis with Frozen Drug Products
193
Chapter 11 Stability Testing for Dissolution
203
Chapter 12 Current Issues and Recent Developments
233
Guidance for Industry
273
SAS Marco Files for STAB System for Stability Analysis
293
References
307
Index
323
Back cover
331

Chapter 9 Stability Analysis with Mulitiple Components
187

Other editions - View all

Common terms and phrases

Popular passages

Page 2 - Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.
Page xvii - This book series will provide comprehensive and unified presentations of statistical designs and analyses of important applications in biostatistics, such as those in biopharmaceuticals. A well-balanced summary will be given of current and recently developed statistical methods and interpretations for both statisticians and researchers/scientists with minimal statistical knowledge who are engaged in the field of applied biostatistics.
Page iii - Dalene K. Stangl and Donald A. Berry 5. Generalized Linear Models: A Bayesian Perspective, Dipak K. Dey, Sujit K. Ghosh, and Bani K. Mallick 6. Difference Equations with Public Health Applications, Lemuel A. Moye and Asha Seth Kapadia 7. Medical Biostatistics, Abhaya Indrayan and Sanjeev B. Sarmukaddam 8. Statistical Methods for Clinical Trials, Mark X. Norleans 9. Causal Analysis in Biomedicine and Epidemiology: Based on Minimal Sufficient Causation, Mikel Aickin 10. Statistics in Drug Research:...
Page 320 - ... changes: chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation...
Page 2 - ... direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those com-ponents that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (8) Inactive ingredient means any component other than an active ingredient.
Page xvii - Biostatistics series are to provide useful reference books for researchers and scientists in academia, industry, and government, and to offer textbooks for undergraduate and/or graduate courses in the area of biostatistics. This book series will provide comprehensive and unified presentations of statistical designs and analyses of important applications in biostatistics, such as those in biopharmaceuticals. A wellbalanced summary...

Bibliographic information