Simcyp Focused Workshop: DDI (Predicting and evaluating complex DDIs) Japan

Join us in Japan for a two-day hands-on workshop on predicting and evaluating complex DDIs—applying the Simcyp Population-based Simulator to real-world cases.

• Participants will learn good practices in combining data from both in vitro and clinical studies, whilst gaining experience in using such data within physiologically-based dynamic models to evaluate the DDI liability of drug candidates.

  • Static vs. dynamic models (including discussion around regulatory guidance)

  • Metabolic and transporter mediated DDIs

  • Competitive inhibition, mechanism-based inhibition, induction, and suppression

  • Complex DDIs involving combined interaction mechanisms and multiple inhibitors (including inhibitory metabolites)

  • Importance of in vitro study design

  • The role of non-hepatic metabolism in DDIs

  • Use of parameter estimation and sensitivity analysis

  • Optimal clinical study design

  • Special populations—identification of individuals at risk of DDI