Predicting the Effect of Cytochrome P450 Inhibitors on Substrate Drugs: Analysis of Physiologically Based Pharmacokinetic Modeling Submissions to the US Food and Drug Administration
Authors:
- 27 September 2014
- journal article
- research article
- Published by Springer Nature in Clinical Pharmacokinetics
- Vol. 54 (1) , 117-127
Abstract
The US Food and Drug Administration (FDA) has seen a recent increase in the application of physiologically based pharmacokinetic (PBPK) modeling towards assessing the potential of drug–drug interactions (DDI) in clinically relevant scenarios. To continue our assessment of such approaches, we evaluated the predictive performance of PBPK modeling in predicting cytochrome P450 (CYP)-mediated DDI.Keywords
This publication has 11 references indexed in Scilit:
- Physiologically Based Pharmacokinetic Modeling: From Regulatory Science to Regulatory PolicyClinical Pharmacology & Therapeutics, 2014
- PBPK Model Describes the Effects of Comedication and Genetic Polymorphism on Systemic Exposure of Drugs That Undergo Multiple Clearance PathwaysClinical Pharmacology & Therapeutics, 2014
- The Utility of Modeling and Simulation in Drug Development and Regulatory ReviewJournal of Pharmaceutical Sciences, 2013
- Evaluation of the Use of Static and Dynamic Models to Predict Drug-Drug Interaction and Its Associated Variability: Impact on Drug Discovery and Early DevelopmentDrug Metabolism and Disposition, 2012
- Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory QuestionsClinical Pharmacology & Therapeutics, 2012
- Physiologically Based Pharmacokinetics Joined With In Vitro–In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems PharmacologyClinical Pharmacology & Therapeutics, 2012
- Physiologically-Based Pharmacokinetics in Drug Development and Regulatory ScienceAnnual Review of Pharmacology and Toxicology, 2011
- Critique of the Two-Fold Measure of Prediction Success for Ratios: Application for the Assessment of Drug-Drug InteractionsDrug Metabolism and Disposition, 2011
- Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory ReviewClinical Pharmacology & Therapeutics, 2010
- 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 CovariatesDrug Metabolism and Pharmacokinetics, 2009