Physiologically-based pharmacokinetic (PBPK) modeling is being increasingly used in drug development to avoid unnecessary clinical drug–drug interaction (DDI) studies and inform drug labels.
Thus, regulatory agencies are recommending more rigorous demonstration of the prediction accuracy of PBPK platforms in their intended use.
During this webinar, we present a framework for qualification of the Simcyp Simulator with respect to competitive and mechanism-based CYP-mediated DDIs involving inhibition that was published recently (click on link below for our recent publication).
We also discuss our strategy and ongoing qualification efforts for other key areas.
Prediction of CYP‐mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator – Kilford – – CPT: Pharmacometrics & Systems Pharmacology – Wiley Online Library