Recorded: 10 April 2025

This webinar will discuss changes in regulatory guidance about predicting the risk of drug-drug interactions (DDIs), as codified in ICH M12 compared with previous FDA and EMA guidance.?

Agenda:

  • The regulatory landscape of in vitro DDI assays ?
  • New aspects of testing requirements according to ICH M12?
    • Drug-metabolizing enzymes?
    • Drug transporters?
    • Impact of binding?
  • Study designs and workflows?
  • Clinical DDI risk prediction?