Model-informed Drug Development Intensive Interactive Courses

Overview: This hands-on workshop is designed to deepen your understanding of the biopharmaceutic aspects of physiologically based pharmacokinetic (PBPK) modelling and its practical applications, including formulation development, virtual bioequivalence and automated safe space assessment. Covering both foundational concepts and case studies. This event offers a comprehensive learning experience for professionals in industry, academia, and regulatory agencies. Workshop Highlights: 1. Overview of the biopharmaceutic/oral absorption modelling tools including modelling of in vitro solubility and dissolution experiments to better understand your data and parameterise biopharmaceutic aspects of PBPK models. 2. Handling of different formulations ranging from suspensions and IR to controlled and modified release including ASDs and salts. 3. Mechanistic modelling of food effects including advanced aspects such as the Magenstrasse. 4. Application of virtual bioequivalence (VBE) and automated safe space tools. 5. Learning best practices and regulatory requirements through case studies. Read more