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Recent Advances in Development and Application of Physiologically-Based Pharmacokinetic (PBPK) Models: a Transition from Academic Curiosity to Regulatory Acceptance

Current pharmacology reports, 2016, Vol.2 (3), p.161-169

Jamei, Masoud

2016

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Prediction of maternal pharmacokinetics using physiologically based pharmacokinetic models: assessing the impact of the longitudinal changes in the activity of CYP1A2, CYP2D6 and CYP3A4 enzymes during pregnancy

Journal of pharmacokinetics and pharmacodynamics, 2020-08, Vol.47 (4), p.361-383

2020

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A Preterm Physiologically Based Pharmacokinetic Model. Part I: Physiological Parameters and Model Building

Clinical pharmacokinetics, 2020-04, Vol.59 (4), p.485-500

2020

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Preterm Physiologically Based Pharmacokinetic Model. Part II: Applications of the Model to Predict Drug Pharmacokinetics in the Preterm Population

Clinical pharmacokinetics, 2020-04, Vol.59 (4), p.501-518

2020

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Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective

Clinical pharmacology and therapeutics, 2018-07, Vol.104 (1), p.88-110

2018

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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

Drug metabolism and pharmacokinetics, 2009-01, Vol.24 (1), p.53-75

2009

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Does age affect gastric emptying time? A model-based meta-analysis of data from premature neonates through to adults

Biopharmaceutics & drug disposition, 2015-05, Vol.36 (4), p.245-257

2015

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Prediction of intestinal first-pass drug metabolism

Current drug metabolism, 2007-10, Vol.8 (7), p.676-684

2007

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Cytochrome p450 turnover: regulation of synthesis and degradation, methods for determining rates, and implications for the prediction of drug interactions

Current drug metabolism, 2008-06, Vol.9 (5), p.384-393

2008

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Development of a permeability-limited model of the human brain and cerebrospinal fluid (CSF) to integrate known physiological and biological knowledge: Estimating time varying CSF drug concentrations and their variability using in vitro data

Drug metabolism and pharmacokinetics, 2016-06, Vol.31 (3), p.224-233

2016

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Prediction of Concentration–Time Profile and its Inter-Individual Variability following the Dermal Drug Absorption

Journal of pharmaceutical sciences, 2012-07, Vol.101 (7), p.2584-2595

2012

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Accelerating the Progress of Kinase Inhibitors in Oncology: The potential of PBPK modeling in answering key questions around these drugs

Applied clinical trials, 2024-05, Vol.33 (5), p.16

2024

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Accelerating the Progress of Kinase Inhibitors in Oncology

Applied clinical trials, 2024-05, Vol.33 (5), p.16-17

2024

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Prediction of Maternal and Fetal Acyclovir, Emtricitabine, Lamivudine, and Metformin Concentrations during Pregnancy Using a Physiologically Based Pharmacokinetic Modeling Approach

Clinical pharmacokinetics, 2022-05, Vol.61 (5), p.725-748

2022

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Fetal Physiologically Based Pharmacokinetic Models: Systems Information on Fetal Blood Components and Binding Proteins

Clinical pharmacokinetics, 2020-05, Vol.59 (5), p.629-642

2020

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Prediction of basic drug exposure in milk using a lactation model algorithm integrated within a physiologically based pharmacokinetic model

Biopharmaceutics & drug disposition, 2022-10, Vol.43 (5), p.201-212

2022

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Fetal Physiologically Based Pharmacokinetic Models: Systems Information on Fetal Cardiac Output and Its Distribution to Different Organs during Development

Clinical pharmacokinetics, 2021-06, Vol.60 (6), p.741-757

2021

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Biopharmaceutic IVIVE—Mechanistic Modeling of Single- and Two-Phase In Vitro Experiments to Obtain Drug-Specific Parameters for Incorporation Into PBPK Models

Journal of pharmaceutical sciences, 2019-04, Vol.108 (4), p.1604-1618

2019

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Biopharmaceutic In Vitro In Vivo Extrapolation (IVIV_E) Informed Physiologically-Based Pharmacokinetic Model of Ritonavir Norvir Tablet Absorption in Humans Under Fasted and Fed State Conditions

Molecular pharmaceutics, 2020-07, Vol.17 (7), p.2329-2344

2020

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Incorporation and Performance Verification of Hepatic Portal Blood Flow Shunting in Minimal and Full PBPK Models of Liver Cirrhosis

Clinical pharmacology and therapeutics, 2023-12, Vol.114 (6), p.1264-1273

2023

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Model-Based Analysis of Biopharmaceutic Experiments To Improve Mechanistic Oral Absorption Modeling: An Integrated in Vitro in Vivo Extrapolation Perspective Using Ketoconazole as a Model Drug

Molecular pharmaceutics, 2017-12, Vol.14 (12), p.4305-4320

2017

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VIVD: A virtual in vitro distribution model for predicting intra- and sub-cellular concentrations in toxicity assays

Toxicology letters, 2017-10, Vol.280, p.S290-S290

2017

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The Simcyp® Population-based ADME Simulator

Expert opinion on drug metabolism & toxicology, 2009-02, Vol.5 (2), p.211-223

2009

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In Silico Modeling Approach for the Evaluation of Gastrointestinal Dissolution, Supersaturation, and Precipitation of Posaconazole

Molecular pharmaceutics, 2017-12, Vol.14 (12), p.4321-4333

2017

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In vitro models for the prediction of in vivo performance of oral dosage forms: Recent progress from partnership through the IMI OrBiTo collaboration

European journal of pharmaceutics and biopharmaceutics, 2019-03, Vol.136, p.70-83

2019

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Recent Advances in Development and Application of Physiologically-Based Pharmacokinetic (PBPK) Models: a Transition from Academic Curiosity to Regulatory Acceptance

Prediction of maternal pharmacokinetics using physiologically based pharmacokinetic models: assessing the impact of the longitudinal changes in the activity of CYP1A2, CYP2D6 and CYP3A4 enzymes during pregnancy

A Preterm Physiologically Based Pharmacokinetic Model. Part I: Physiological Parameters and Model Building

Preterm Physiologically Based Pharmacokinetic Model. Part II: Applications of the Model to Predict Drug Pharmacokinetics in the Preterm Population

Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective

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

Does age affect gastric emptying time? A model-based meta-analysis of data from premature neonates through to adults

Prediction of intestinal first-pass drug metabolism

Cytochrome p450 turnover: regulation of synthesis and degradation, methods for determining rates, and implications for the prediction of drug interactions

Development of a permeability-limited model of the human brain and cerebrospinal fluid (CSF) to integrate known physiological and biological knowledge: Estimating time varying CSF drug concentrations and their variability using in vitro data

Prediction of Concentration–Time Profile and its Inter-Individual Variability following the Dermal Drug Absorption

Accelerating the Progress of Kinase Inhibitors in Oncology: The potential of PBPK modeling in answering key questions around these drugs

Accelerating the Progress of Kinase Inhibitors in Oncology

Prediction of Maternal and Fetal Acyclovir, Emtricitabine, Lamivudine, and Metformin Concentrations during Pregnancy Using a Physiologically Based Pharmacokinetic Modeling Approach

Fetal Physiologically Based Pharmacokinetic Models: Systems Information on Fetal Blood Components and Binding Proteins

Prediction of basic drug exposure in milk using a lactation model algorithm integrated within a physiologically based pharmacokinetic model

Fetal Physiologically Based Pharmacokinetic Models: Systems Information on Fetal Cardiac Output and Its Distribution to Different Organs during Development

Biopharmaceutic IVIVE—Mechanistic Modeling of Single- and Two-Phase In Vitro Experiments to Obtain Drug-Specific Parameters for Incorporation Into PBPK Models

Biopharmaceutic In Vitro In Vivo Extrapolation (IVIV_E) Informed Physiologically-Based Pharmacokinetic Model of Ritonavir Norvir Tablet Absorption in Humans Under Fasted and Fed State Conditions

Incorporation and Performance Verification of Hepatic Portal Blood Flow Shunting in Minimal and Full PBPK Models of Liver Cirrhosis

Model-Based Analysis of Biopharmaceutic Experiments To Improve Mechanistic Oral Absorption Modeling: An Integrated in Vitro in Vivo Extrapolation Perspective Using Ketoconazole as a Model Drug

VIVD: A virtual in vitro distribution model for predicting intra- and sub-cellular concentrations in toxicity assays

The Simcyp® Population-based ADME Simulator

In Silico Modeling Approach for the Evaluation of Gastrointestinal Dissolution, Supersaturation, and Precipitation of Posaconazole

In vitro models for the prediction of in vivo performance of oral dosage forms: Recent progress from partnership through the IMI OrBiTo collaboration

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