Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices [Hardcover]

Stability Regulations.- Critical Regulatory Requirements for a Stability Program.- Understanding ICH Guidelines Applicable to Stability Testing.- Global Stability Practices.- Post-approval Changes  Stability Requirements and Regulations.- Understanding and Predicting Pharmaceutical Product Shelf-Life.- Stability Methodologies and Best Practices.- Development of Stability Indicating Methods.- Method Validation and Transfer.- Overview of USP-NF Requirements for Stability Purposes.- Non-chromatographic Methods to Support Stability Program.- Vibrational Spectroscopic Methods for Quantitative Analysis.- Impact of Solid-State Characteristics to the Physical Stability of Drug Substance and Drug Product.- Evaluation of Stability Data.- Qualification, Calibration, and Maintenance of Stability Chambers.- Stability Operation Practices.- Other Stability Programs.- Combination Products/Drugs in Devices.- Stability Studies for Biologics.

Kim Huynh-Ba is Technical Director of Pharmalytik. She has over 20 years of experiences in various analytical areas of pharmaceutical development, especially in Stability Sciences. She has involved with several projects harmonizing or optimizing analytical best practices in several companies, including those are under Consent Decree. Ms. Huynh-Ba has authored numerous technical publications and book chapters. She is a frequent invited speaker at national and international conferences. She has conducted several training courses on stability compliance and quality issues for American Chemical Society, American Association of Pharmaceutical Scientists, Pharmaceutical Training Institute, Eastern Analytical Symposium since 2001. She is the founder of AAPS Stability Focus Group and actively involved with Pharmaceutical Stability Discussion Group. She is an active member of ACS, AAPS, PSDG, ASQ, POMA and serves in the Governing Board of Eastern Analytical Symposium (EAS).

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