Model Informed Drug Development Archives

Publication

Poor Correlation between Urinary Excretion of the Principal Urinary Metabolites of Phenytoin and Absolute Oral Bioavailability Determined by a Stable Isotope Method in Epilepsy Patients

The anticonvulsant properties of phenytoin (PHT) were discovered in 1938. Since then, it has been…

Certara2011 年 2 月 1 日

Publication

Unexpected Effect of Rifampin on the Pharmacokinetics of Linezolid: In Silico and In Vitro Approaches to Explain Its Mechanism

The effect of rifampin on the steady-state pharmacokinetics of linezolid was evaluated in an open-label,…

Certara2011 年 2 月 1 日

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…

Certara2011 年 2 月 1 日

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…

Certara2011 年 2 月 1 日

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…

Certara2011 年 1 月 1 日

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…

Certara2010 年 12 月 1 日

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)…

Certara2010 年 11 月 1 日

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…

Certara2010 年 11 月 1 日

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…

Certara2010 年 11 月 1 日

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…

Certara2010 年 10 月 1 日

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Poor Correlation between Urinary Excretion of the Principal Urinary Metabolites of Phenytoin and Absolute Oral Bioavailability Determined by a Stable Isotope Method in Epilepsy Patients

Unexpected Effect of Rifampin on the Pharmacokinetics of Linezolid: In Silico and In Vitro Approaches to Explain Its Mechanism

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

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