Pharmaceutical Stability Testing to Support Global Markets

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 submissionStability testing in challenging storage environment such as ASEAN or Caribbean region.Exploring concept of Quality by Design as it applies to stability testingUnderstanding stability challenges of biologics, generics, nutraceutical, and other new product technologySetting specifications for Drug Substances as well as various type of drug productsExploring concerns on changes of stability profiles such as repackaged products, split tabletsDiscussing safety and toxicology concerns of emerging impurities.Understanding physical effects on product stabilityStability to support temperature excursion during shippingAssessing impurities and degradation product in developmentLeveraging stability data to expedite regulatory approvalManaging relationship with Contract Research Organizations