Model Informed Drug Development Archives

Publication

Quantitative Prediction of Formulation-specific Food Effects and Their Population Variability from In Vitro Data Using the Physiologically-based ADAM Model: A Case Study Using BCS/BDDCS Class II Drug Nifedipine.

Quantitative prediction of food effects (FE) upon drug pharmacokinetics, including population variability, in advance of human trials may help with trial design by optimizing…

CertaraJune 16, 2014

Publication

Population Pharmacokinetics and Bayesian Estimation of Tacrolimus Exposure in Pediatric Liver Transplant Recipients

Objectives of this study were to develop a population pharmacokinetic (PopPK) model for tacrolimus in…

CertaraJune 1, 2014

Publication

The ISoP Standards and Best Practices Committee

The mission of the International Society of Pharmacometrics (ISoP) Standards and Best Practices Committee is…

CertaraJune 1, 2014

Publication

Model-based Meta-analysis for Quantifying Paclitaxel Dose Response in Cancer Patients

Model-based meta-analysis of dose response is a sophisticated method to guide dose and regimen selection.…

CertaraMay 21, 2014

Poster

Modeling the Binding Kinetics of Bispecific Antibodies under the Framework of a Minimal Human PBPK Model

CertaraMay 19, 2014

Publication

Improving the Assessment of Heart Toxicity for All New Drugs Through Translational Regulatory Science

Fourteen drugs have been removed from the market worldwide because they cause torsade de pointes.…

CertaraMay 1, 2014

Publication

Changes in Individual Drug-independent System Parameters during Virtual Pediatric Pharmacokinetic Trials: Introducing Time-varying Physiology into a Pediatric PBPK Model

Although both POPPK and physiologically based pharmacokinetic (PBPK) models can account for age and other covariates within…

CertaraMay 1, 2014

Publication

Evaluation of Tumor Size Response Metrics to Predict Survival in Oncology Clinical Trials

Model-based drug development in oncology is still lagging despite a good momentum in the clinical…

CertaraApril 1, 2014

Publication

Exploratory Modeling and Simulation to Support Development of Motesanib in Asian Patients with Non-small Cell Lung Cancer Based on MONET1 Study Results

The motesanib phase III MONET1 study failed to show improvement in overall survival (OS) in…

CertaraApril 1, 2014

Publication

Population Pharmacokinetics of Azithromycin in Whole Blood, Peripheral Blood Mononuclear Cells, and Polymorphonuclear Cells in Healthy Adults

Azithromycin's extensive distribution to proinflammatory cells, including peripheral blood mononuclear cells (PBMCs) and polymorphonuclear cells…

CertaraMarch 5, 2014

Model Informed Drug Development

Quantitative Prediction of Formulation-specific Food Effects and Their Population Variability from In Vitro Data Using the Physiologically-based ADAM Model: A Case Study Using BCS/BDDCS Class II Drug Nifedipine.

Population Pharmacokinetics and Bayesian Estimation of Tacrolimus Exposure in Pediatric Liver Transplant Recipients

The ISoP Standards and Best Practices Committee

Model-based Meta-analysis for Quantifying Paclitaxel Dose Response in Cancer Patients

Modeling the Binding Kinetics of Bispecific Antibodies under the Framework of a Minimal Human PBPK Model

Improving the Assessment of Heart Toxicity for All New Drugs Through Translational Regulatory Science

Changes in Individual Drug-independent System Parameters during Virtual Pediatric Pharmacokinetic Trials: Introducing Time-varying Physiology into a Pediatric PBPK Model

Evaluation of Tumor Size Response Metrics to Predict Survival in Oncology Clinical Trials

Exploratory Modeling and Simulation to Support Development of Motesanib in Asian Patients with Non-small Cell Lung Cancer Based on MONET1 Study Results

Population Pharmacokinetics of Azithromycin in Whole Blood, Peripheral Blood Mononuclear Cells, and Polymorphonuclear Cells in Healthy Adults

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