This workshop report summarizes the proceedings of Day 1 of a three-day workshop on “Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls”. Physiologically based biopharmaceutics models (PBBM) are tools which enable the drug product quality attributes to be linked to the in vivo performance. These tools rely on key quality inputs in order to provide reliable predictions. After introducing the objectives of the workshop and the expectations from the breakout sessions, Day 1 of the workshop focused on the best practices and challenges in measuring in vitro inputs needed for modeling, such as the drug solubility, the dissolution rate of the drug product, potential precipitation of the drug and drug permeability. This paper reports the podium presentations and summarizes breakout session discussions related to A) the best strategies for determining solubility, supersaturation and critical supersaturation; B) the best strategies for the development of biopredictive (clinically relevant) dissolution methods; C) the challenges associated with describing gastro-intestinal systems parameters such as mucus, liquid volume and motility; and D) the challenges with translating biopharmaceutical measures of drug permeability along the gastrointestinal tract to a meaningful model parameter.

By Xavier JH.Pepin, Jennifer Dressman, Neil Parrott, Poonam Delvadia, Amitava Mitra, Xinyuan Zhang, Andrew Babiskin, Vidula Kolhatkar, Paul Seo, Lynne S.Taylor, Erik Sjögren, James M.Butler, Edmund Kostewicz, Christer Tannergren, Mirko Koziolek, Filippos Kesisoglou, André Dallmann, Yang Zhao, Sandra Suarez-Sharp