By Kim Huynh-Ba, Editor
Published in: Pharmaceutical Stability Testing to Support Global Markets
Published on: January 1, 2010
This book provides an understanding of the regulatory perspective of Stability Testing and positions the stability program for the 21st century globally. It comprises several sessions organized in dual tracks to explore different stability related challenges, such as monitoring impurities, evaluating shipping excursions, setting specifications and estimating expiry. Stability is a crucial sector of the Drug Development Process. Companies rely on the stability data to establish an expiry for marketed pharmaceutical products. Many guidelines have been developed around this arena; however, many continue to be raised and challenge our practices.
Best Practices • Best Practices • Best Practices • Best Practices • Data Analysis • Determination • Excursions • Extension • Extrapolation • Guidances • Methods • Parameters • Planning • Regulations • Regulatory • Shelf-Life • Specifications • Statistics • Study Design • Testing
