Model Informed Drug Development Archives

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

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 …

Certara2010 年 9 月 1 日

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…

Certara2010 年 8 月 21 日

Publication

A Modeling and Simulation Framework to Support Early Clinical Drug Development Decisions in Oncology

Certara2010 年 7 月 13 日

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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

A Modeling and Simulation Framework to Support Early Clinical Drug Development Decisions in Oncology

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