Tag: Kim Huynh-Ba

Pharmaceutical Stability Testing to Support Global Markets: This book is written by Kim Huynh-Ba which you can download freely in pdf format. The International Conference on Harmonization (ICH) has worked on the harmonization of stability standards in the US, Europe, and Japan since the early 1990s. Although the Q1A(R2) Stability Guidelines were issued for more than a decade, issues related to this field continue to arise as the principles outlined in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and seek ways to harmonize regulatory requirements, streamline practices, and improve processes to bring safe and effective medical supplies to patients around the world. In 2007, the American Association of...