Pharmaceutical Stability Testing to Support Global Markets
| Preis: | 203.29 EUR* (inkl. MWST zzgl. Versand - Preis kann jetzt höher sein!) |
| Versand: | 0.00 EUR Versandkostenfrei innerhalb von Deutschland |
| Partner: | buecher.de |
| Hersteller: | Springer, Berlin; Aaps Press (Ed.: Huynh-Ba, Kim) |
| Stand: | 2015-08-04 03:50:33 |
Produktbeschreibung
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 21 st 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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