The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presen

In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all

This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development

Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutic