Model Informed Drug Development Archives

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

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…

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

論文

The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?

A collaboration between the Consortium for Innovation and Quality in Pharmaceutical Development and the Cardiac…

webdev2014年1月1日

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モデルに基づく医薬品開発

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

The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?

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