Overview

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.

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9781441908902

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