Application of PBPK modelling in drug discovery and development at Pfizer

Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

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

Simulation of Human Intravenous and Oral Pharmacokinetics of 21 Diverse Compounds Using Physiologically Based Pharmacokinetic Modelling

(2011) Hannah M. Jones et al.   CLINICAL PHARMACOKINETICS

Preclinical and Clinical Pharmacokinetics of PF-02413873, a Nonsteroidal Progesterone Receptor Antagonist

(2011) P. J. Bungay et al.   DRUG METABOLISM AND DISPOSITION

Pharmacokinetic profile of fesoterodine

(2011) B. Malhotra et al.   INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

Assessment of algorithms for predicting drug-drug interactions via inhibition mechanisms: comparison of dynamic and static models

(2010) Eleanor J. Guest et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

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

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

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

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

Prediction of Oral Pharmacokinetics of cMet Kinase Inhibitors in Humans: Physiologically Based Pharmacokinetic Model Versus Traditional One-Compartment Model

(2010) S. Yamazaki et al.   DRUG METABOLISM AND DISPOSITION

Radioimmunotherapy with Anti-CD66 Antibody: Improving the Biodistribution Using a Physiologically Based Pharmacokinetic Model

(2010) P. Kletting et al.   JOURNAL OF NUCLEAR MEDICINE

Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect

(2010) Min Gao et al.   NATURE

Membrane transporters in drug development

(2010)   NATURE REVIEWS DRUG DISCOVERY

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

Metabolites in Safety Testing (MIST): Considerations of Mechanisms of Toxicity with Dose, Abundance, and Duration of Treatment

(2009) Dennis A. Smith et al.   CHEMICAL RESEARCH IN TOXICOLOGY

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

(2009) Agnès Poirier et al.   CHEMISTRY & BIODIVERSITY

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

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

Development of a PBPK Model for Monoclonal Antibodies and Simulation of Human and Mice PBPK of a Radiolabelled Monoclonal Antibody

(2009) Tomi Heiskanen et al.   CURRENT PHARMACEUTICAL DESIGN

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

Evaluation of drug–drug interactions with fesoterodine

(2009) Bimal Malhotra 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

Introduction to computational oral absorption simulation

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

Prediction of Human Pharmacokinetics From Preclinical Information: Comparative Accuracy of Quantitative Prediction Approaches

(2009) Natilie A. Hosea et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Improving Anti-CD45 Antibody Radioimmunotherapy Using a Physiologically Based Pharmacokinetic Model

(2009) P. Kletting et al.   JOURNAL OF NUCLEAR MEDICINE

Physiologically based pharmacokinetic model for T84.66: A monoclonal anti-CEA antibody

(2009) Shweta R. Urva et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Interplay of Drug Metabolism and Transport: A Real Phenomenon or an Artifact of the Site of Measurement?

(2009) Christopher J. Endres et al.   MOLECULAR PHARMACEUTICS

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

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

Physiology-Based Simulations of a Pathological Condition

(2008) Andrea N Edginton et al.   CLINICAL PHARMACOKINETICS

Evaluation of a Generic Physiologically Based Pharmacokinetic Model for Lineshape Analysis

(2008) Sheila Annie Peters   CLINICAL PHARMACOKINETICS

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

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

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

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

Pharmacokinetic predictions in children by using the physiologically based pharmacokinetic modelling

(2008) F. Bouzom et al.   FUNDAMENTAL & CLINICAL PHARMACOLOGY

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

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

A regulatory viewpoint on transporter-based drug interactions

(2008) L. Zhang et al.   XENOBIOTICA

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