Normal view MARC view ISBD view

Pharmaceutical Stability Testing to Support Global Markets Ed by Kim Huynh-Ba

By: Huynh-Ba, Kim.
Material type: materialTypeLabelBookPublisher: New York Springer Science+Business Media, Inc 2010Description: 265p.ISBN: 9781441908889.DDC classification: 615.19
Tags from this library: No tags from this library for this title. Log in to add tags.
    average rating: 0.0 (0 votes)
Item type Current location Collection Call number Status Date due Barcode Item holds
Book Book Institute of Pharmacy
Reference 615.19 PHA (Browse shelf) Not For Loan P0007322
Total holds: 0

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.

There are no comments for this item.

Log in to your account to post a comment.

Copyrights © Nirma University 2018. All Right Reserved