Model Informed Drug Development Archives

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…

webdev2014 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…

webdev2014 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…

webdev2014 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…

webdev2014 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…

webdev2014 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…

webdev2014 年 3 月 1 日

刊物

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…

webdev2014 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…

webdev2014 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…

webdev2014 年 2 月 13 日

Publication

A Systems Pharmacology Perspective on the Clinical Development of Fatty Acid Amide Hydrolase Inhibitors for Pain

The level of the endocannabinoid anandamide is controlled by fatty acid amide hydrolase (FAAH). In…

webdev2014 年 1 月 15 日

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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

A Systems Pharmacology Perspective on the Clinical Development of Fatty Acid Amide Hydrolase Inhibitors for Pain

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