This project has been archived.

Drug-Drug Interaction Victim Working Group

This group will explore methods and strategies to predict metabolism-based DDI potential of NCEs as “victim” drugs. It will be focused on how to determine the route of clearance of an NCE and on identifying enzymes involved in the clearance of an NCE and their contribution to total clearance of the NCEs. Two subteams will make recommendations about the scope of another focus area: how to predict DDI magnitude using available methods and models.

SCOPE

Integrate existing best practices for use of in vitro methods (estimation of clearance pathway and fraction metabolized), in vivo preclinical studies, modeling and simulation, to evaluate the potential of a NCE to be a victim of metabolic DDIs in the clinic

• Determine contribution of hepatic, biliary, and renal clearance, fCL

• Determine fractional contribution of CYPs & non-CYPs towards NCE disposition, fm, enzyme

• Recommend Modeling & Simulation Strategy (Integrating fCL & fm) for victim DDI prediction to influence decision-making at different stages of drug development via case studies