Mechanistic PBPK Simulation in Place of In Vivo Drug-Drug Interaction (DDI) Studies for Compliance with Regulatory Requirements of EMA and FDA

Authors: Bolger MB, Woltosz WS, Lukacova V, Chung J, Zhou H, Fraczkiewicz G, Lavé T, Parrott N
Conference: AAPS
Keywords: DDIs, drug-drug interactions (DDIs), European Medicines Agency (EMA), PBPK, PBPK modeling, U.S. FDA
Software: GastroPlus®
Division: PBPK

Purpose

To highlight the application and validation of PBPK DDI simulation results obtained using GastroPlus™ in compliance with newly proposed European Medicines Agency (EMA) and US FDA guidelines for the investigation of drug interactions.

American Association of Pharmaceutical Scientists (AAPS), November 14-18, 2010, New Orleans, LA

By Michael B. Bolger, Walter S. Woltosz, Viera Lukacova, John I. Chung, Haiying Zhou, Grazyna Fraczkiewicz, Thierry Lave, Neil J. Parrott