Requirements to Establishing Confidence in Physiologically Based Pharmacokinetic (PBPK) Models and Overcoming Some of the Challenges to Meeting Them

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

(2018) Mohamad Shebley et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Food Effect Projections via Physiologically Based Pharmacokinetic Modeling: Predictive Case Studies

(2018) Christophe Tistaert et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Commentary on fit-for-purpose models for regulatory applications

(2018) Yaning Wang et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Assessment of OATP transporter-mediated drug-drug interaction using physiologically-based pharmacokinetic (PBPK) modeling - a case example

(2018) Yuan Chen et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Prediction of ARA/PPI Drug-Drug Interactions at the Drug Discovery and Development Interface

(2018) Stephanie Dodd et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

(2018) Manuela Grimstein et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically based pharmacokinetic modeling in regulatory decision-making at the European Medicines Agency

(2016) E Luzon et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Forecasting oral absorption across biopharmaceutics classification system classes with physiologically based pharmacokinetic models

(2016) Simone Hansmann et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

PBPK modeling and simulation in drug research and development

(2016) Xiaomei Zhuang et al.   Acta Pharmaceutica Sinica B

Mechanistic understanding of the nonlinear pharmacokinetics and intersubject variability of simeprevir: A PBPK-guided drug development approach

(2015) J Snoeys et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Physiologically based pharmacokinetic modeling in drug discovery and development: A pharmaceutical industry perspective

(2015) HM Jones et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Development of physiologically based pharmacokinetic model to evaluate the relative systemic exposure to quetiapine after administration of IR and XR formulations to adults, children and adolescents

(2014) Trevor N. Johnson et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Combining the ‘bottom up’ and ‘top down’ approaches in pharmacokinetic modelling: fitting PBPK models to observed clinical data

(2013) Nikolaos Tsamandouras et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

The Utility of Modeling and Simulation in Drug Development and Regulatory Review

(2013) Shiew-Mei Huang et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

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

Sources of interindividual variability in IVIVE of clearance: an investigation into the prediction of benzodiazepine clearance using a mechanistic population-based pharmacokinetic model

(2011) Helen E. Cubitt et al.   XENOBIOTICA

In silico prediction of efavirenz and rifampicin drug-drug interaction considering weight and CYP2B6 phenotype

(2010) Dinko Rekić et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Human radiolabeled mass balance studies: objectives, utilities and limitations

(2009) Natalia Penner et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Identification of Intestinal Loss of a Drug through Physiologically Based Pharmacokinetic??Simulation of Plasma??Concentration-Time Profiles

(2008) Sheila Annie Peters   CLINICAL PHARMACOKINETICS

Evaluation of a Generic Physiologically Based Pharmacokinetic Model for Lineshape Analysis

(2008) Sheila Annie Peters   CLINICAL PHARMACOKINETICS

Biomedical accelerator mass spectrometry: recent applications in metabolism and pharmacokinetics

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