Model Informed Drug Development Archives

Publication

Critique of the Two-fold Measure of Prediction Success for Ratios: Application for the Assessment of Drug-drug Interactions

Current assessment of drug-drug interaction (DDI) prediction success is based on whether predictions fall within a two-fold range of the observed data. This strategy…

CertaraFebruary 1, 2011

Publication

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

Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can help predict the…

CertaraFebruary 1, 2011

Publication

Assessment of Algorithms for Predicting Drug-drug Interactions Via Inhibition Mechanisms: Comparison of Dynamic and Static Models

The prediction of drug-drug interactions (DDIs) from in vitro data usually utilizes an average dosing…

CertaraJanuary 1, 2011

Publication

Modeling Disease Progression in Acute Stroke Using Clinical Assessment Scales

This article demonstrates techniques for describing and predicting disease progression in acute stroke by modeling…

CertaraDecember 1, 2010

Publication

Development of a Modeling Framework to Simulate Efficacy Endpoints for Motesanib in Thyroid Cancer Patients

To develop a modeling framework that simulates clinical endpoints (objective response rate and progression-free survival)…

CertaraNovember 1, 2010

Publication

Population Pharmacokinetic/Pharmacodynamic Modeling for the Time Course of Tumor Shrinkage by Motesanib in Thyroid Cancer Patients

To develop a population pharmacokinetic/pharmacodynamic model describing the relationship between motesanib exposure and tumor response…

CertaraNovember 1, 2010

Publication

Determination of a Quantitative Relationship Between Hepatic CYP3A51/3 and CYP3A4 Expression for Use in the Prediction of Metabolic Clearance in Virtual Populations

The creation of virtual populations allows the estimation of pharmacokinetic parameters, such as metabolic clearance…

CertaraNovember 1, 2010

Publication

Incorporating Human Dosimetry and Exposure into High-throughput In Vitro Toxicity Screening

Many chemicals in commerce today have undergone limited or no safety testing. To reduce the…

CertaraOctober 1, 2010

Publication

Mechanistic Toxicokinetic Model for γ-Hydroxybutyric Acid: Inhibition of Active Renal Reabsorption as a Potential Therapeutic Strategy

γ-Hydroxybutyric acid (GHB), a drug of abuse, exhibits saturable renal clearance and capacity-limited metabolism. The …

CertaraSeptember 1, 2010

Publication

A Pharmacokinetic/Pharmacodynamic Model for Cardiovascular Safety Assessment of R1551

Pharmacokinetic-pharmacodynamic relationships are crucial in understanding a drug's arrhythmogenic potential. Models assist to quantitatively relate…

CertaraAugust 21, 2010

Model Informed Drug Development

Critique of the Two-fold Measure of Prediction Success for Ratios: Application for the Assessment of Drug-drug Interactions

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

Assessment of Algorithms for Predicting Drug-drug Interactions Via Inhibition Mechanisms: Comparison of Dynamic and Static Models

Modeling Disease Progression in Acute Stroke Using Clinical Assessment Scales

Development of a Modeling Framework to Simulate Efficacy Endpoints for Motesanib in Thyroid Cancer Patients

Population Pharmacokinetic/Pharmacodynamic Modeling for the Time Course of Tumor Shrinkage by Motesanib in Thyroid Cancer Patients

Determination of a Quantitative Relationship Between Hepatic CYP3A51/3 and CYP3A4 Expression for Use in the Prediction of Metabolic Clearance in Virtual Populations

Incorporating Human Dosimetry and Exposure into High-throughput In Vitro Toxicity Screening

Mechanistic Toxicokinetic Model for γ-Hydroxybutyric Acid: Inhibition of Active Renal Reabsorption as a Potential Therapeutic Strategy

A Pharmacokinetic/Pharmacodynamic Model for Cardiovascular Safety Assessment of R1551

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