ABSTRACT

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 sta

chapter 1|24 pages

Introduction

chapter 2|28 pages

Accelerated Testing

chapter 3|20 pages

Expiration Dating Period

chapter 4|26 pages

Stability Designs

chapter 5|26 pages

Stability Analysis with Fixed Batches

chapter 6|40 pages

Stability Analysis with Random Batches

chapter 7|10 pages

Linear Mixed Effects Model

chapter 8|12 pages

Stability Analysis with Discrete Responses

chapter 10|10 pages

Stability Analysis with Frozen Drug Products

chapter 11|30 pages

Stability Testing for Dissolution

chapter 12|40 pages

Current Issues and Recent Developments