Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

Effect of Obesity on the Pharmacokinetics of Drugs in Humans

(2010) Michael J. Hanley et al.   CLINICAL PHARMACOKINETICS

Predictions of Metabolic Drug-Drug Interactions Using Physiologically Based Modelling

(2010) Nathalie Perdaems et al.   CLINICAL PHARMACOKINETICS

A Semi-Mechanistic Model to Predict the Effects of Liver Cirrhosis on Drug Clearance

(2010) Trevor N. Johnson et al.   CLINICAL PHARMACOKINETICS

Applying Physiological and Biochemical Concepts to Optimize Biological Drug Development

(2010) PJ Lowe   CLINICAL PHARMACOLOGY & THERAPEUTICS

Inflammation: Planning for a Source of Pharmacokinetic/Pharmacodynamic Variability in Translational Studies

(2010) V D Schmith et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Therapeutic Protein–Drug Interactions and Implications for Drug Development

(2010) S-M Huang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Dosing in Children

(2010) N Holford   CLINICAL PHARMACOLOGY & THERAPEUTICS

Design and Application of Microfluidic Systems for In Vitro Pharmacokinetic Evaluation of Drug Candidates

(2010) T. Maguire et al.   CURRENT DRUG METABOLISM

Quantitative Prediction of Intestinal Metabolism in Humans from a Simplified Intestinal Availability Model and Empirical Scaling Factor

(2010) K. Kadono et al.   DRUG METABOLISM AND DISPOSITION

Confidence Assessment of the Simcyp Time-Based Approach and a Static Mathematical Model in Predicting Clinical Drug-Drug Interactions for Mechanism-Based CYP3A Inhibitors

(2010) Y.-H. Wang   DRUG METABOLISM AND DISPOSITION

Prediction of Human Intestinal First-Pass Metabolism of 25 CYP3A Substrates from In Vitro Clearance and Permeability Data

(2010) M. Gertz et al.   DRUG METABOLISM AND DISPOSITION

Theoretical Considerations on Quantitative Prediction of Drug-Drug Interactions

(2010) Akihiro Hisaka et al.   Drug Metabolism and Pharmacokinetics

Pharmacokinetic modeling of the hepatobiliary transport mediated by cooperation of uptake and efflux transporters

(2010) Hiroyuki Kusuhara et al.   DRUG METABOLISM REVIEWS

Unexpected Effect of Rifampin on the Pharmacokinetics of Linezolid: In Silico and In Vitro Approaches to Explain Its Mechanism

(2010) Kuan Gandelman et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Bioavailability Considerations in Evaluating Drug-Drug Interactions Using the Population Pharmacokinetic Approach

(2010) John Z. Duan et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Whole-body physiologically based pharmacokinetic population modelling of oral drug administration: inter-individual variability of cimetidine absorption

(2010) Stefan Willmann et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

Membrane transporters in drug development

(2010)   NATURE REVIEWS DRUG DISCOVERY

Drug interactions evaluation: An integrated part of risk assessment of therapeutics

(2010) Lei Zhang et al.   TOXICOLOGY AND APPLIED PHARMACOLOGY

Predicting Pharmacokinetics of Drugs Using Physiologically Based Modeling—Application to Food Effects

(2009) N. Parrott et al.   AAPS Journal

Simulations of the Nonlinear Dose Dependence for Substrates of Influx and Efflux Transporters in the Human Intestine

(2009) Michael B. Bolger et al.   AAPS Journal

Mechanistic Approaches to Predicting Oral Drug Absorption

(2009) Weili Huang et al.   AAPS Journal

Prediction of Hepatic Clearance in Human From In Vitro Data for Successful Drug Development

(2009) Masato Chiba et al.   AAPS Journal

Predicting Drug–Drug Interactions: An FDA Perspective

(2009) Lei Zhang et al.   AAPS Journal

Modelling and PBPK Simulation in Drug Discovery

(2009) Hannah M. Jones et al.   AAPS Journal

Prediction of Modified Release Pharmacokinetics and Pharmacodynamics from In Vitro, Immediate Release, and Intravenous Data

(2009) Viera Lukacova et al.   AAPS Journal

Population-Based Mechanistic Prediction of Oral Drug Absorption

(2009) Masoud Jamei et al.   AAPS Journal

Proposals for model-based paediatric medicinal development within the current European Union regulatory framework

(2009) Efthymios Manolis et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

A population-based study of the drug interaction between proton pump inhibitors and clopidogrel

(2009) D. N. Juurlink et al.   CANADIAN MEDICAL ASSOCIATION JOURNAL

Prediction of Pharmacokinetic Profile of Valsartan in Humans Based onin vitroUptake-Transport Data

(2009) Agnès Poirier et al.   CHEMISTRY & BIODIVERSITY

Methodological Uncertainty in Quantitative Prediction of Human Hepatic Clearance from In Vitro Experimental Systems

(2009) D. Hallifax et al.   CURRENT DRUG METABOLISM

Towards a Quantitative Framework for the Prediction of DDIs Arising from Cytochrome P450 Induction

(2009) L. Almond et al.   CURRENT DRUG METABOLISM

Prediction of Human Drug-Drug Interactions from Time-Dependent Inactivation of CYP3A4 in Primary Hepatocytes Using a Population-Based Simulator

(2009) L. Xu et al.   DRUG METABOLISM AND DISPOSITION

Quantitative Prediction of in Vivo Profiles of CYP3A4 Induction in Humans from in Vitro Results with a Reporter Gene Assay

(2009) M. Kozawa et al.   DRUG METABOLISM AND DISPOSITION

Identification of Cytochrome P450 Isoforms Involved in the Metabolism of Paroxetine and Estimation of Their Importance for Human Paroxetine Metabolism Using a Population-Based Simulator

(2009) J. Jornil et al.   DRUG METABOLISM AND DISPOSITION

Semiphysiologically Based Pharmacokinetic Models for the Inhibition of Midazolam Clearance by Diltiazem and Its Major Metabolite

(2009) X. Zhang et al.   DRUG METABOLISM AND DISPOSITION

In Vitro and in Vivo Induction of Cytochrome P450: A Survey of the Current Practices and Recommendations: A Pharmaceutical Research and Manufacturers of America Perspective

(2009) V. Chu et al.   DRUG METABOLISM AND DISPOSITION

The Conduct of in Vitro Studies to Address Time-Dependent Inhibition of Drug-Metabolizing Enzymes: A Perspective of the Pharmaceutical Research and Manufacturers of America

(2009) S. W. Grimm et al.   DRUG METABOLISM AND DISPOSITION

Comparison of Different Algorithms for Predicting Clinical Drug-Drug Interactions, Based on the Use of CYP3A4 in Vitro Data: Predictions of Compounds as Precipitants of Interaction

(2009) O. A. Fahmi et al.   DRUG METABOLISM AND DISPOSITION

In vitro-in vivo Extrapolation of Transporter-mediated Clearance in the Liver and Kidney

(2009) Hiroyuki Kusuhara et al.   Drug Metabolism and Pharmacokinetics

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

Physiologically based pharmacokinetics (PBPK)

(2009) Pascal Espié et al.   DRUG METABOLISM REVIEWS

Assessment of inter-individual variability in predicted phenytoin clearance

(2009) Thomas M. Polasek et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

In vitro-in vivo extrapolation of zolpidem as a perpetrator of metabolic interactions involving CYP3A

(2009) Thomas M. Polasek et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Physiologically based mechanistic modelling to predict complex drug–drug interactions involving simultaneous competitive and time-dependent enzyme inhibition by parent compound and its metabolite in both liver and gut—The effect of diltiazem on the time-course of exposure to triazolam

(2009) Karen Rowland Yeo et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Human clearance prediction: shifting the paradigm

(2009) Thierry Lavé et al.   Expert Opinion on Drug Metabolism & Toxicology

The Simcyp®Population-based ADME Simulator

(2009) Masoud Jamei et al.   Expert Opinion on Drug Metabolism & Toxicology

Introduction to computational oral absorption simulation

(2009) Kiyohiko Sugano   Expert Opinion on Drug Metabolism & Toxicology

Quantitative Evaluation of Pharmacokinetic Inhibition of CYP3A Substrates by Ketoconazole: A Simulation Study

(2009) Ping Zhao et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Authors' Response

(2009) Shiew-Mei Huang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Development of a novel method for predicting human volume of distribution at steady-state of basic drugs and comparative assessment with existing methods

(2009) Patrick Poulin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically Based Predictions of the Impact of Inhibition of Intestinal and Hepatic Metabolism on Human Pharmacokinetics of CYP3A Substrates

(2009) Frederique Fenneteau et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Assessing drug distribution in tissues expressing P-glycoprotein using physiologically based pharmacokinetic modeling: identification of important model parameters through global sensitivity analysis

(2009) Frederique Fenneteau et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Prediction of pharmacokinetic profile of valsartan in human based on in vitro uptake transport data

(2009) Agnès Poirier et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

A method for robust model order reduction in pharmacokinetics

(2009) Aristides Dokoumetzidis et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Mechanistic Insight from In Silico Pharmacokinetic Experiments: Roles of P-glycoprotein, Cyp3A4 Enzymes, and Microenvironments

(2009) T. N. Lam et al.   JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Scientific and Regulatory Perspectives on Metabolizing Enzyme−Transporter Interplay and Its Role in Drug Interactions: Challenges in Predicting Drug Interactions†

(2009) Lei Zhang et al.   MOLECULAR PHARMACEUTICS

Impact of Hepatic Uptake Transporters on Pharmacokinetics and Drug−Drug Interactions: Use of Assays and Models for Decision Making in the Pharmaceutical Industry

(2009) Mathew G. Soars et al.   MOLECULAR PHARMACEUTICS

Mechanistic Modeling of Hepatic Transport from Cells to Whole Body: Application to Napsagatran and Fexofenadine

(2009) Agnès Poirier et al.   MOLECULAR PHARMACEUTICS

Interplay of Transporters and Enzymes in Drug and Metabolite Processing

(2009) K. Sandy Pang et al.   MOLECULAR PHARMACEUTICS

Physiologically-Based PK/PD Modelling of Therapeutic Macromolecules

(2009) Peter Thygesen et al.   PHARMACEUTICAL RESEARCH

Assessing the efficiency of mixed effects modelling in quantifying metabolism based drug-drug interactions: usingin vitrodata as an aid to assess study power

(2009) Trevor N. Johnson et al.   PHARMACEUTICAL STATISTICS

Prediction of Phase I single-dose pharmacokinetics using recombinant cytochromes P450 and physiologically based modelling

(2009) C. R. Gibson et al.   XENOBIOTICA

Utilization of estimated physicochemical properties as an integrated part of predicting hepatic clearance in the early drug-discovery stage: Impact of plasma and microsomal binding

(2009) C. Emoto et al.   XENOBIOTICA

Application of Gastrointestinal Simulation for Extensions for Biowaivers of Highly Permeable Compounds

(2008) Marija Tubic-Grozdanis et al.   AAPS Journal

Application of CYP3A4 in vitro data to predict clinical drug–drug interactions; predictions of compounds as objects of interaction

(2008) Kuresh A. Youdim et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Maraviroc:in vitroassessment of drug-drug interaction potential

(2008) Ruth Hyland et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Physiology-Based Simulations of a Pathological Condition

(2008) Andrea N Edginton et al.   CLINICAL PHARMACOKINETICS

General Framework for the Prediction of Oral Drug Interactions Caused by CYP3A4 Induction from In Vivo Information

(2008) Yoshiyuki Ohno et al.   CLINICAL PHARMACOKINETICS

Free Drug Metabolic Clearance in Elderly People

(2008) Jennifer M Butler et al.   CLINICAL PHARMACOKINETICS

Emerging Evidence of the Impact of Kidney Disease on Drug Metabolism and Transport

(2008) TD Nolin et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Monoclonal Antibody Pharmacokinetics and Pharmacodynamics

(2008) W Wang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Cytochrome P450 Turnover: Regulation of Synthesis and Degradation, Methods for Determining Rates, and Implications for the Prediction of Drug Interactions

(2008) Jiansong Yang et al.   CURRENT DRUG METABOLISM

Methods for Predicting In Vivo Pharmacokinetics Using Data from In Vitro Assays

(2008) J. Houston et al.   CURRENT DRUG METABOLISM

Predictive Physiologically Based Pharmacokinetic Model for Antibody-Directed Enzyme Prodrug Therapy

(2008) L. Fang et al.   DRUG METABOLISM AND DISPOSITION

Prediction of the Pharmacokinetics of Atorvastatin, Cerivastatin, and Indomethacin Using Kinetic Models Applied to Isolated Rat Hepatocytes

(2008) S. W. Paine et al.   DRUG METABOLISM AND DISPOSITION

The "Albumin Effect" and Drug Glucuronidation: Bovine Serum Albumin and Fatty Acid-Free Human Serum Albumin Enhance the Glucuronidation of UDP-Glucuronosyltransferase (UGT) 1A9 Substrates but Not UGT1A1 and UGT1A6 Activities

(2008) A. Rowland et al.   DRUG METABOLISM AND DISPOSITION

Modeling, Prediction, and in Vitro in Vivo Correlation of CYP3A4 Induction

(2008) M. Shou et al.   DRUG METABOLISM AND DISPOSITION

A Combined Model for Predicting CYP3A4 Clinical Net Drug-Drug Interaction Based on CYP3A4 Inhibition, Inactivation, and Induction Determined in Vitro

(2008) O. A. Fahmi et al.   DRUG METABOLISM AND DISPOSITION

Trend Analysis of a Database of Intravenous Pharmacokinetic Parameters in Humans for 670 Drug Compounds

(2008) R. S. Obach et al.   DRUG METABOLISM AND DISPOSITION

Design, Data Analysis, and Simulation of in Vitro Drug Transport Kinetic Experiments Using a Mechanistic in Vitro Model

(2008) A. Poirier et al.   DRUG METABOLISM AND DISPOSITION

Physicochemical characterization of five glyburide powders: A BCS based approach to predict oral absorption

(2008) H WEI et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Computer simulations using GastroPlus™ to justify a biowaiver for etoricoxib solid oral drug products

(2008) Arthur Okumu et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

The utility of microdosing over the past 5 years

(2008) Graham Lappin et al.   Expert Opinion on Drug Metabolism & Toxicology

Whole body physiologically-based pharmacokinetic models: their use in clinical drug development

(2008) Andrea N Edginton et al.   Expert Opinion on Drug Metabolism & Toxicology

New Era in Drug Interaction Evaluation: US Food and Drug Administration Update on CYP Enzymes, Transporters, and the Guidance Process

(2008) Shiew-Mei Huang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Methodology for development of a physiological model incorporating CYP3A and P-glycoprotein for the prediction of intestinal drug absorption

(2008) Raj Badhan et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically Based Pharmacokinetic Modeling to Predict Transporter-Mediated Clearance and Distribution of Pravastatin in Humans

(2008) T. Watanabe et al.   JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Approaches for Applications of Physiologically Based Pharmacokinetic Models in Risk Assessment

(2008) Chad M. Thompson et al.   JOURNAL OF TOXICOLOGY AND ENVIRONMENTAL HEALTH-PART B-CRITICAL REVIEWS

Applications of Physiologically Based Absorption Models in Drug Discovery and Development

(2008) Neil Parrott et al.   MOLECULAR PHARMACEUTICS

Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation

(2008) Ivan Kovačević et al.   MOLECULAR PHARMACEUTICS

The Quantitative Prediction of CYP-mediated Drug Interaction by Physiologically Based Pharmacokinetic Modeling

(2008) Motohiro Kato et al.   PHARMACEUTICAL RESEARCH

Prediction of the Effects of Genetic Polymorphism on the Pharmacokinetics of CYP2C9 Substrates from In Vitro Data

(2008) Makiko Kusama et al.   PHARMACEUTICAL RESEARCH

Dynamic Dissolution Testing To Establish In Vitro/In Vivo Correlations for Montelukast Sodium, a Poorly Soluble Drug

(2008) Arthur Okumu et al.   PHARMACEUTICAL RESEARCH

Pre-clinical pharmacokinetics of UK-453,061, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI), and use ofin silicophysiologically based prediction tools to predict the oral pharmacokinetics of UK-453,061 in man

(2008) G. Allan et al.   XENOBIOTICA

A physiologically based pharmacokinetic (PBPK) model to characterize and predict the disposition of monoclonal antibody CC49 and its single chain Fv constructs

(2007) Jasmine P. Davda et al.   INTERNATIONAL IMMUNOPHARMACOLOGY