Accelerated Predictive Stability (APS)

Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. APS is an innovative science and risk-based pharmaceutical stability testing approach that has become increasingly popular in recent years. The fundamental chapters authored by the most respected scientists in this field explain the scientific basis of the APS approach, while the case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry as well as numerous specific examples on where and how APS can be applied in the drug development life cycle. In addition, the up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for a successful implementation of APS in a pharmaceutical company and sufficient details for newcomers to practice APS at the bench level. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product's stability and predict drug expiry more accurately and quickly.

• A comprehensive one-stop-shop resource for accelerated predictive stability (APS)
• Scientific basis of different APS models explained
• Applications and utilities of APS demonstrated through numerous case studies
• Up-to-date regulatory experience included