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, ...
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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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Add this copy of Pharmaceutical Stability Testing to Support Global to cart. $98.40, very good condition, Sold by Greenworld Books rated 5.0 out of 5 stars, ships from Arlington, TX, UNITED STATES, published 2009 by Springer.
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Fast-Very good condition with a sturdy cover and clean pages. Lightly read and well cared for showing only minimal shelf wear. May contain a few small marks but remains a solid copy to enjoy. Supplemental items like CDs or access codes may not be included.
Add this copy of Pharmaceutical Stability Testing to Support Global to cart. $140.64, good condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Santa Clarita, CA, UNITED STATES, published 2009 by Springer.
Add this copy of Pharmaceutical Stability Testing to Support Global to cart. $180.70, new condition, Sold by Just one more Chapter rated 4.0 out of 5 stars, ships from Miramar, FL, UNITED STATES, published 2009 by Springer.
