Last chance to register for CDER SBIA & CERSI Workshop - Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls – Sep. 23-25, 2019

Workshop: Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls Sep. 23-25, 2019 | College Park, MD A collaboration between CDER's Office of Pharmaceutical Quality, Small Business and Industry Association, and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). Agenda

Topics Include: Approaches to measure equilibrium (intrinsic) and kinetic solubility, surface pH and the impact on dissolution. The value of biorelevant media for measuring solubility and in the development of biopredictive dissolution methods. Strategies for determining solubility, supersaturation and critical supersaturation. Strategies for the development of biopredictive (clinically relevant) dissolution methods, a key element for successful modeling and simulation. Gastrointestinal systems parameters (mucus, volume, motility): Where are the pitfalls and how can we overcome them? Challenges to predict effects of formulation changes (e.g. particle size distribution changes) on dissolution and in vivo performance using in silico models.  Strategies to handle parameter uncertainty and variability within and between subjects. Register Now This workshop will provide a forum for regulators, drug developers, and academicians to: identify biopharmaceutics and modeling strategies (including model development, verification, and validation) to facilitate formulation development and to enhance risk management of bioperformance over the product’s life cycle; demonstrate the rewards and challenges of coupling biopredictive dissolution testing with translational PBBM; and identify knowledge gaps, and a path forward to advance the application of physiologically based biopharmaceutics modeling .