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

PBPK Model Describes the Effects of Comedication and Genetic Polymorphism on Systemic Exposure of Drugs That Undergo Multiple Clearance Pathways

(2014) M d L T Vieira et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Itraconazole and Clarithromycin as Ketoconazole Alternatives for Clinical CYP3A Inhibition Studies

(2014) A B Ke et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Physiologically Based Pharmacokinetic Modeling: From Regulatory Science to Regulatory Policy

(2014) V Sinha et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The Utility of Modeling and Simulation in Drug Development and Regulatory Review

(2013) Shiew-Mei Huang et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically Based Pharmacokinetics Joined With In Vitro–In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology

(2012) A Rostami-Hodjegan   CLINICAL PHARMACOLOGY & THERAPEUTICS

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

(2012) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

(2011) Malcolm Rowland et al.   Annual Review of Pharmacology and Toxicology

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

(2010) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Critique of the Two-Fold Measure of Prediction Success for Ratios: Application for the Assessment of Drug-Drug Interactions

(2010) E. J. Guest et al.   DRUG METABOLISM AND DISPOSITION

A Framework for Assessing Inter-individual Variability in Pharmacokinetics Using Virtual Human Populations and Integrating General Knowledge of Physical Chemistry, Biology, Anatomy, Physiology and Genetics: A Tale of ‘Bottom-Up’ vs ‘Top-Down’ Recognition of Covariates

(2009) Masoud Jamei et al.   Drug Metabolism and Pharmacokinetics