Applying Physiologically-Based Pharmacokinetic (PBPK) Modeling & Simulation to Assist with Pharmaceutical Research and Regulatory Submissions

Applying Physiologically-Based Pharmacokinetic (PBPK) Modeling & Simulation to Assist with Pharmaceutical Research and Regulatory Submissions

Authors: Morris D
Conference: CERSI
Keywords: drug inputs, Physiologically based pharmacokinetic (PBPK) modeling, regulatory submission, United States Food and Drug Administration
Software: GastroPlus®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Open communication between regulatory agencies, pharmaceutical companies, universities, and software providers will help identify new M&S applications.

Development of a Physiologically Based Pharmacokinetic Model for Raltegravir and Prediction of its Interactions with Rifampicin

Development of a Physiologically Based Pharmacokinetic Model for Raltegravir and Prediction of its Interactions with Rifampicin

Authors: Macwan J, Bolger MB, Lukacova V, Fraczkiewicz G, Woltosz WS
Conference: AAPS
Keywords: drug-drug interactions (DDIs), HIV/TB, metabolism, PBPK modeling, Raltegravir, Rifampicin
Software: GastroPlus®
Division: PBPK

Raltegravir (MK-0518; Isentress™), the HIV-1 integrase strand transfer inhibitor is approved for HIV-1 therapy in combination with other antiretroviral agents.