Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

Ping Zhao, L Zhang, Joseph A. Grillo et al. · Clinical Pharmacology & Therapeutics · 2010 · 518 citations

Pharmacy, Pharmacokinetics, Pharmacology +13

Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK

Christian Wagner, Ping Zhao, Y. Pan et al. · CPT Pharmacometrics & Systems Pharmacology · 2015 · 268 citations · Full text

Pharmacy, Pharmacokinetics, Pharmacology +13

Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions

Ping Zhao, Malcolm Rowland, Huang Sm · Clinical Pharmacology & Therapeutics · 2012 · 211 citations · Full text

Pharmacy, Pharmacokinetics, Pharmacology +14

Cyclosporine Inhibition of Hepatic and Intestinal CYP3A4, Uptake and Efflux Transporters: Application of PBPK Modeling in the Assessment of Drug-Drug Interaction Potential

Michael Gertz, Catherine M. Cartwright, Michael Hobbs et al. · Pharmaceutical Research · 2012 · 148 citations

Pharmacy, Pharmacokinetics, Pharmacology +17

Predicting the Effect of Cytochrome P450 Inhibitors on Substrate Drugs: Analysis of Physiologically Based Pharmacokinetic Modeling Submissions to the US Food and Drug Administration

Christian Wagner, Yuzhuo Pan, Vicky Hsu et al. · Clinical Pharmacokinetics · 2014 · 145 citations

Pharmacy, Pharmacokinetics, Pharmacology +17