Statistical Design and Analysis of Stability Studies

Hardcover (Print)
Buy New
Buy New from BN.com
$103.99
Used and New from Other Sellers
Used and New from Other Sellers
from $36.22
Usually ships in 1-2 business days
(Save 68%)
Other sellers (Hardcover)
  • All (6) from $36.22   
  • New (5) from $36.22   
  • Used (1) from $99.28   

Overview

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.

Read More Show Less

Product Details

Table of Contents

INTRODUCTION
Background
Regulatory Requirements
Stability Testing
Practical Issues
Aim and Scope of the Book

ACCELERATED TESTING
Chemical Kinetic Reaction
Statistical Analysis and Prediction
Examinations of Model Assumptions
An Example
Discussion

EXPIRATION DATING PERIOD
Basic Concepts
Shelf-Life Estimation
Other Methods
Concluding Remarks

STABILITY DESIGNS
Basic Design Considerations
Long-Term Stability Designs
Design Selection
Discussion

STABILITY ANALYSIS WITH FIXED BATCHES
Preliminary Test for Batch Similarity
Minimum Approach for Multiple Batches
Multiple Comparison Procedure for Pooling Batches
Example
Discussion

STABILITY ANALYSIS WITH RANDOM BATCHES
Linear Regression with Random Coefficients
Random Batch Effect and Other Fixed Effects
Shelf-Life Estimation with Random Batches
Comparison of Methods for Multiple Batches
Determining Shelf Life Based on the Lower Prediction Bound
Concluding Remarks

STABILITY ANALYSIS WITH A MIXED EFFECTS MODEL
Linear Mixed Effects Model
Restricted Maximum Likelihood Estimation
Restricted Maximum Likelihood Estimation
The EM Algorithm Procedure
Example
Discussion

STABILITY ANALYSIS WITH DISCRETE RESPONSES
Binary Data without Batch-To-Batch Variation
The Case of Random Batches
Testing for Batch-To-Batch Variation
Example
Ordinal Responses
Concluding Remarks

STABILITY ANALYSIS WITH MULTIPLE COMPONENTS
Basic Idea
Models and Assumptions
Shelf-Life Determination
Example
Discussion

STABILITY ANALYSIS WITH FROZEN DRUG PRODUCTS
Two-Phase Stability Study
Stability Data and Model
An Example
Discussion

STABILITY TESTING FOR DISSOLUTION
USP/NF Dissolution Testing
Dissolution Profile Testing
Statistical Methods for Assessing Similarity
Numerical Examples
Concluding Remarks

CURRENT ISSUES AND RECENT DEVELOPMENTS
Scale-Up and Postapproval Changes
Storage Conditions in Different Climatic Zones
Optimal Designs in Stability Studies
Current Issues in Stability Analysis
SAS Programs for Stability Analysis

APPENDIX A: Guidance for Industry
APPENDIX B: SAS Macro Files for STAB System for Stability Analysis

REFERENCES

INDEX

Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star

(0)

4 Star

(0)

3 Star

(0)

2 Star

(0)

1 Star

(0)

Your Rating:

Your Name: Create a Pen Name or

Barnes & Noble.com Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & Noble.com that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & Noble.com does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at BN.com or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation

Reminder:

  • - By submitting a review, you grant to Barnes & Noble.com and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Noble.com Terms of Use.
  • - Barnes & Noble.com reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & Noble.com also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on BN.com. It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

 
Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)