pre-update Archives

Publication

Model-based Meta-analysis for Quantifying Paclitaxel Dose Response in Cancer Patients

Model-based meta-analysis of dose response is a sophisticated method to guide dose and regimen selection.…

CertaraMay 21, 2014

Poster

Modeling the Binding Kinetics of Bispecific Antibodies under the Framework of a Minimal Human PBPK Model

CertaraMay 19, 2014

Publication

Improving the Assessment of Heart Toxicity for All New Drugs Through Translational Regulatory Science

Fourteen drugs have been removed from the market worldwide because they cause torsade de pointes.…

CertaraMay 1, 2014

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…

CertaraMay 1, 2014

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…

CertaraApril 1, 2014

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…

CertaraApril 1, 2014

Publication

Physiologically-based Pharmacokinetic Modeling Framework for Quantitative Prediction of an Herb–Drug Interaction

Herb–drug interaction predictions remain challenging. Physiologically based pharmacokinetic (PBPK) modeling was used to improve prediction…

CertaraMarch 26, 2014

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…

CertaraMarch 5, 2014

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…

CertaraMarch 1, 2014

Publication

Electrocardiographic Data Quality in Thorough QT/QTc Studies

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

CertaraMarch 1, 2014

pre-update

Model-based Meta-analysis for Quantifying Paclitaxel Dose Response in Cancer Patients

Modeling the Binding Kinetics of Bispecific Antibodies under the Framework of a Minimal Human PBPK Model

Improving the Assessment of Heart Toxicity for All New Drugs Through Translational Regulatory Science

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

Physiologically-based Pharmacokinetic Modeling Framework for Quantitative Prediction of an Herb–Drug Interaction

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

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