Oncology/Hematology Archives

Publication

Modeling & Simulation Relating Survival to Tumor Growth Inhibition in Patients

The published OS model and resultant simulations can be leveraged to support Phase II design…

CertaraSeptember 1, 2015

Publication

Population Pharmacokinetic Modeling of Motesanib and Its Active Metabolite, M4, in Cancer Patients

Motesanib is a small molecule and potent multikinase inhibitor with antiangiogenic and antitumor activity. Population…

CertaraJuly 23, 2015

Publication

Population Pharmacokinetic Analysis of Thrombomodulin Alfa to Support Dosing Rationale in Patients with Renal Impairment

Thrombomodulin alfa is a soluble recombinant human thrombomodulin that was reported to enhance the reversal…

CertaraMay 1, 2015

Publication

Onartuzumab with or without Bevacizumab in Combination with Weekly Paclitaxel Does Not Prolong QTc or Adversely Affect Other ECG Parameters in Patients with Locally Recurrent or Metastatic Triple-negative Breast Cancer

The purpose of this study was to examine the potential effect of onartuzumab, when administered…

CertaraDecember 17, 2014

Publication

Assessment of Tumor Growth Inhibition Metrics to Predict Overall Survival

Modeling and simulation is proposed to support drug development phase transitions in oncology. Longitudinal tumor-size…

CertaraAugust 1, 2014

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

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

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

Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers

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

CertaraFebruary 21, 2014

Oncology/Hematology

Modeling & Simulation Relating Survival to Tumor Growth Inhibition in Patients

Population Pharmacokinetic Modeling of Motesanib and Its Active Metabolite, M4, in Cancer Patients

Population Pharmacokinetic Analysis of Thrombomodulin Alfa to Support Dosing Rationale in Patients with Renal Impairment

Onartuzumab with or without Bevacizumab in Combination with Weekly Paclitaxel Does Not Prolong QTc or Adversely Affect Other ECG Parameters in Patients with Locally Recurrent or Metastatic Triple-negative Breast Cancer

Assessment of Tumor Growth Inhibition Metrics to Predict Overall Survival

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

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

Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers

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