Accelerated Stability Assessment Program (ASAP): Fundamentals and Pharmaceutical Industry Practices

2017 | Medical & Veterinary

Accelerated Stability Assessment Program (ASAP): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and applications of the ASAP approach. This book includes practical knowledge and insights by presenting numerous industry case studies that cover important areas of drug development where stability testing is required, including the retest period/shelf life of a drug substance or product, support of chemical process development, and justification of use period for reference materials. Users will find a set of standard conditions on how to design an ASAP protocol. The book offers scientists and regulators a complete reference source that illustrates how the pharmaceutical industry can enhance the understanding of a product's stability attributes and more accurately, and quickly, determine drug expiry.

Fenghe Qiu (Author)

Garry Scrivens (Author)