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Ameeting on Dissolution and Quality by Design (QbD), co-sponsored by Extension Services in Pharmacy, School of Pharmacy, University of Wisconsin and FDA in cooperation with AAPS, was held June 10–12, 2009, in Rockville, MD. In the first talk, “Impact of QbD and Future Expectations: Role of Biopharmaceutics and Quality by Design for in vitro Dissolution/Release Specifications Setting,” Helen Winkle of FDA stated that the future of CMC review is QbD and related tools that will allow companies to build better quality into their products. Significant scientific and technological advances are facilitating improved bridging of product development and manufacturing to clinical relevance. She asked, as we gain momentum from the new QbD paradigm, what would be new and unique opportunities from early integration of biopharmaceutics? An outcome of the conference could be a better understanding of the relationship between biopharmaceuticals and QbD and how the integration can improve the regulatory process. The second speaker was Arzu Selen, also of FDA, who spoke on “Introduction to the Conference Workshop Objectives, Program

dissolution technologies

Meeting Report: University of Wisconsin/ AAPS/FDA Workshop–Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit