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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 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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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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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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PBPK models for the prediction of in vivo performance of oral dosage forms

European journal of pharmaceutical sciences, 2014-06, Vol.57 (SI), p.300-321

2014

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An Application of a Physiologically Based Pharmacokinetic Approach to Predict Ceftazidime Pharmacokinetics in a Pregnant Population

Pharmaceutics, 2024-04, Vol.16 (4), p.474

2024

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Simulation of Monoclonal Antibody Pharmacokinetics in HumansUsing a Minimal Physiologically Based Model

The AAPS journal, 2014-07, Vol.16 (5), p.1097-1109

2014

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Population-Based Mechanistic Prediction of Oral Drug Absorption

The AAPS journal, 2009-06, Vol.11 (2), p.225-237

2009

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Mechanistic PBPK Modelling to Predict the Advantage of the Salt Form of a Drug When Dosed with Acid Reducing Agents

Pharmaceutics, 2021-07, Vol.13 (8), p.1169

2021

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Prediction of intestinal first-pass drug metabolism

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

2007

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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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Application of a Physiologically Based Pharmacokinetic Approach to Predict Theophylline Pharmacokinetics Using Virtual Non-Pregnant, Pregnant, Fetal, Breast-Feeding, and Neonatal Populations

Frontiers in pediatrics, 2022-05, Vol.10, p.840710-840710

2022

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Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Predict the Impact of CYP2C9 Genetic Polymorphisms, Co-Medication and Formulation on the Pharmacokinetics and Pharmacodynamics of Flurbiprofen

Pharmaceutics, 2020-11, Vol.12 (11), p.1049

2020

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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

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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Developing Clinically Relevant Dissolution Specifications for Oral Drug Products-Industrial and Regulatory Perspectives

Pharmaceutics, 2019-12, Vol.12 (1), p.19

2019

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Development of physiologically‐based pharmacokinetic models for standard of care and newer tuberculosis drugs

CPT: pharmacometrics and systems pharmacology, 2021-11, Vol.10 (11), p.1382-1395

2021

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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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Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin

CPT: pharmacometrics and systems pharmacology, 2022-08, Vol.11 (8), p.1060-1084

2022

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Application of Physiologically Based Pharmacokinetic (PBPK) Modeling Within a Bayesian Framework to Identify Poor Metabolizers of Efavirenz (PM), Using a Test Dose of Efavirenz

Frontiers in pharmacology, 2018-03, Vol.9, p.247-247

2018

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Prediction of the Pharmacokinetics, Pharmacodynamics, and Efficacy of a Monoclonal Antibody, Using a Physiologically Based Pharmacokinetic FcRn Model

Frontiers in immunology, 2015-01, Vol.5, p.670-670

2015

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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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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 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

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

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

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

PBPK models for the prediction of in vivo performance of oral dosage forms

An Application of a Physiologically Based Pharmacokinetic Approach to Predict Ceftazidime Pharmacokinetics in a Pregnant Population

Simulation of Monoclonal Antibody Pharmacokinetics in HumansUsing a Minimal Physiologically Based Model

Population-Based Mechanistic Prediction of Oral Drug Absorption

Mechanistic PBPK Modelling to Predict the Advantage of the Salt Form of a Drug When Dosed with Acid Reducing Agents

Prediction of intestinal first-pass drug metabolism

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

Application of a Physiologically Based Pharmacokinetic Approach to Predict Theophylline Pharmacokinetics Using Virtual Non-Pregnant, Pregnant, Fetal, Breast-Feeding, and Neonatal Populations

Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Predict the Impact of CYP2C9 Genetic Polymorphisms, Co-Medication and Formulation on the Pharmacokinetics and Pharmacodynamics of Flurbiprofen

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

Developing Clinically Relevant Dissolution Specifications for Oral Drug Products-Industrial and Regulatory Perspectives

Development of physiologically‐based pharmacokinetic models for standard of care and newer tuberculosis drugs

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

Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin

Application of Physiologically Based Pharmacokinetic (PBPK) Modeling Within a Bayesian Framework to Identify Poor Metabolizers of Efavirenz (PM), Using a Test Dose of Efavirenz

Prediction of the Pharmacokinetics, Pharmacodynamics, and Efficacy of a Monoclonal Antibody, Using a Physiologically Based Pharmacokinetic FcRn Model

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

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