Pharmaceutical Stability Testing to Support Global Markets

Name: Pharmaceutical Stability Testing to Support Global Markets
Brand: Springer-Verlag New York Inc.
SKU: 9781441908889
Price: 878.89 RON
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Autor: Kim Huynh-Ba

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Legare: Copertă tare

Editura: Springer-Verlag New York Inc.

Disponibilitate: În depozitul extern

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This book is a proceedings of the AAPS Stability Workshop. This workshop provide an understanding of...

Informații despre carte

Autor

Kim Huynh-Ba

Limbă

engleză

Legare

Carte - Copertă tare

Publicat

2009

Pagini

266

EAN

9781441908889

ISBN

1441908889

Enbook ID

01420503

Editura

Springer-Verlag New York Inc.

Greutate

810

Dimensiuni

186 x 260 x 25

Descriere completă

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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Pharmaceutical Stability Testing to Support Global Markets

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