Product Description
This book is a proceedings of the AAPS Stability Workshop. This workshop provide an understanding of the regulatory perspective of Stability Testing and position the stability program for 21st century globally by:
- Learning regulatory initiatives on global stability submission.
- Stability testing in challenging storage environment such as ASEAN or Caribbean region.
- Exploring concept of Quality by Design as it applies to stability testing.
- Understanding stability challenges of biologics, generics, nutraceutical, and other new product technology.
- Setting specifications for Drug Substances as well as various type of drug products.
- Exploring concerns on changes of stability profiles such as repackaged products, split tablets.
- Discussing safety and toxicology concerns of emerging impurities.
- Understanding physical effects on product stability.
- Stability to support temperature excursion during shipping.
- Assessing impurities and degradation product in development.
- Leveraging stability data to expedite regulatory approval.
- Managing relationship with Contract Research Organizations.