Simcyp Focused Workshop: DDI

July 11-12, 2024 - Post MDO Meeting

Hotel Olšanka, Prague, Czech Republic

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