Pharmaceutical Stability Testing to Support Global Markets
Pharmaceutical Stability Testing to Support Global Markets
Springer | 268 Pages | 2009-12-17 | ISBN-10 : 1441908889 | PDF | 3.06 Mb
Springer | 268 Pages | 2009-12-17 | ISBN-10 : 1441908889 | PDF | 3.06 Mb
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.