In Vitro Biopredictive Methods: A Workshop Summary Report

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