Abstract
This is a summary report of the workshop entitled “Dissolution Testing for the Twenty-first Century: Linking Critical Quality Attributes and Critical Process Parameters to Clinically Relevant Dissolution,” organized by the In Vitro Release and Dissolution Testing Focus Group of the American Association of Pharmaceutical Scientists. Participants from the pharmaceutical industry, regulatory authorities, and academia in the US, Europe, and Japan attended this workshop to review, discuss, and explore the role of traditional dissolution testing in the new arena of Quality by Design (QbD) and Process Analytical Technology (PAT). Other areas of discussion were the use of the dissolution test to evaluate drug release from novel dosage forms, challenges in dissolution testing and specification setting, and dissolution apparatus calibration using performance verification tablets versus mechanical calibration. The workshop identified areas where further research and collaboration are needed to advance knowledge and understanding of the science of dissolution. Views expressed in this report are those of the authors and do not necessarily reflect those of the FDA and USP.
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2006 AAPS Dissolution Workshop Planning Committee: Tahseen M. Mirza, Ph.D., Novartis Pharmaceuticals, Co-chair; Saji K. Thomas, M.Sc. Barr Labs, Inc., Co-chair; Vivian A. Gray, V.A. Gray Consulting, Inc.; Beverly Nickerson, Ph.D., Pfizer, Inc.; Alger Salt, GalxoSmithKline; Allen C. Templeton, Ph.D., Merck & Co., Inc.; Kailas, D. Thakker, Ph.D., Analytical Solutions, Inc.; Terry Wilke, Pfizer, Inc.; Melvin H. Weinswig, Ph.D., University of Wisconsin-Madison, Continuing Education
Highlights of the AAPS Workshop on Dissolution Testing for the 21st Century, Jan Parker and Vivian Gray, Dissolution Technologies, Volume 13, Issue 3, August 2006
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Tong, C., D’Souza, S.S., Parker, J.E. et al. Commentary on AAPS Workshop. Pharm Res 24, 1603–1607 (2007). https://doi.org/10.1007/s11095-007-9280-x
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DOI: https://doi.org/10.1007/s11095-007-9280-x