Overview
- Provides an understanding of the regulatory perspective of Stability Testing and position the stability program for 21st century globally
- Comprises several sessions organized in dual tracks to explore different stability related challenges, such as monitoring impurities, evaluating shipping excursions, setting specifications, estimating expiry
- Stability is a crucial sector of the Drug Development Process. Companies rely on the stability data to establish an expiry for marketed pharmaceutical products. Many guidelines have been developed around this arena; however, many issues are continued to raise and challenge our practices
Part of the book series: Biotechnology: Pharmaceutical Aspects (PHARMASP, volume XII)
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Table of contents (31 chapters)
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Front Matter
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Section I
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Front Matter
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Stability Studies in a Global Environment
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Front Matter
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Technical Concepts for Stability Program
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Front Matter
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Keywords
About this book
Editors and Affiliations
About the editor
Kim Huynh-Ba is the founder and Technical Director of Pharmalytik (www.pharmalytik.com). She has twenty two years of experience in various analytical areas of pharmaceutical development and a primary focus in stability sciences. Prior to Pharmalytik, she held positions in drug development at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She has been advising pharmaceutical companies including companies operating under Consent Decree on harmonization and optimization of analytical best practices since 2001.
In addition to her consulting activities, Kim is a short course instructor and organizer on topics ranging from cGMP compliance and quality issues to stability programs under sponsorship of global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, many other international training groups. She is the founder and past co-chair of the AAPS Stability Focus Group, and an active member of the Pharmaceutical Stability Discussion Group (PSDG). She serves on the Governing Board of Eastern Analytical Symposium (EAS). She currently is Chair of the AAPS APQ e-Learning Committee and the 2008 EAS Short Course Program. She is a member of USP's Prescription/Non-Prescription Stakeholder Forum and also USP Reference Standard Project Team.
Kim Huynh-Ba is a recipient of the 2008 AAPS APQ Service Award and 2008 Recognition Award of AAPS Regulatory Section. She also received the 2001 DPCAA Leadership Award.
Kim Huynh-Ba has authored numerous technical publications and book chapters. She is invited frequently to present at national and international conferences. She is the editor of the Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices, which has been recognized as a practical reference book in the stability community.
Bibliographic Information
Book Title: Pharmaceutical Stability Testing to Support Global Markets
Editors: Kim Huynh-Ba
Series Title: Biotechnology: Pharmaceutical Aspects
DOI: https://doi.org/10.1007/978-1-4419-0889-6
Publisher: Springer New York, NY
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: Springer-Verlag New York 2010
Hardcover ISBN: 978-1-4419-0888-9Published: 17 December 2009
Softcover ISBN: 978-1-4614-2536-6Published: 25 February 2012
eBook ISBN: 978-1-4419-0889-6Published: 04 December 2009
Edition Number: 1
Number of Pages: XX, 266
Number of Illustrations: 7 b/w illustrations, 4 illustrations in colour
Topics: Pharmacology/Toxicology
