Abstract
This is a summary report of the “AAPS Workshop on the Role of Dissolution in QbD and Drug Product Life Cycle” or ganized by the AAPS In Vitro Release and Dissolution Testing (IVDRT) Focus Group. Representatives from the pharmaceutical industry, regulatory authorities, and academia in the U.S. and Europe attended this workshop to discuss the role of dissolution in a Quality by Design (QbD) setting and its relevance in drug product development. Other areas of discussion included IVIVC/R and hot topics like alcohol dose-dumping. Numerous case studies were presented, and issues relevant to the dissolution scientist and areas needing further research were highlighted at this workshop. Views expressed in this paper are those of the participants from the industry and the agency and do not necessarily represent those of the FDA and USP.
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