Model Informed Drug Development Archives

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…

Certara2014年5月1日

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…

Certara2014年4月1日

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…

Certara2014年4月1日

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…

Certara2014年3月5日

Publication

Impact of Electrocardiographic Data Quality on Moxifloxacin Response in Thorough QT/QTc Studies

Thorough QT studies are typically conducted for drugs with systemic bioavailability and include a positive…

Certara2014年3月1日

Publication

Electrocardiographic Data Quality in Thorough QT/QTc Studies

Most drugs with systemic bioavailability have to undergo a thorough QT (TQT) study, which includes…

Certara2014年3月1日

Publication

In Vitro-In Vivo Extrapolation of Drug-induced Proarrhythmia Predictions at the Population Level

Drug cardiotoxicity is a serious issue for patients, regulators, pharmaceutical companies and health service payers…

Certara2014年3月1日

論文

Precision Criteria to Derive Sample Size When Designing Pediatric Pharmacokinetics Studies: Which Measure of Variability Should be Used?

A new approach for calculation of sample size in pediatric clinical pharmacokinetic studies was suggested based on desired precision for a pharmacokinetic parameter…

Certara2014年3月1日

Publication

Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers

Axitinib is a potent and selective second generation inhibitor of vascular endothelial growth factor receptors…

Certara2014年2月21日

Publication

A Model-based Meta-analysis to Compare Efficacy and Tolerability of Tramadol and Tapentadol for the Treatment of Chronic Non-malignant Pain

Pain is a major symptom in many medical conditions which can be relieved thanks to…

Certara2014年2月13日

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モデルに基づく医薬品開発

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

Impact of Electrocardiographic Data Quality on Moxifloxacin Response in Thorough QT/QTc Studies

Electrocardiographic Data Quality in Thorough QT/QTc Studies

In Vitro-In Vivo Extrapolation of Drug-induced Proarrhythmia Predictions at the Population Level

Precision Criteria to Derive Sample Size When Designing Pediatric Pharmacokinetics Studies: Which Measure of Variability Should be Used?

Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers

A Model-based Meta-analysis to Compare Efficacy and Tolerability of Tramadol and Tapentadol for the Treatment of Chronic Non-malignant Pain

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