商品簡介
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.
作者簡介
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.
