Simulations Using a Drug-disease Modeling Framework and Phase 2 Data Predict Phase 3 Survival Outcome in First-line Non-small Cell Lung Cancer Publication Simulations Using a Drug-disease Modeling Framework and Phase 2 Data Predict Phase 3 Survival Outcome in First-line Non-small Cell Lung Cancer Simulations were performed for carboplatin/paclitaxel (C/P) plus motesanib or bevacizumab vs. C/P as first-line treatment…CertaraNovember 1, 2012
Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of BMS-599626 (AC480), an Oral Pan-HER Receptor Tyrosine Kinase Inhibitor, in Patients with Advanced Solid Tumors Publication Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of BMS-599626 (AC480), an Oral Pan-HER Receptor Tyrosine Kinase Inhibitor, in Patients with Advanced Solid Tumors We studied the safety, tolerability, and recommended dose of BMS-599626, an orally bioavailable inhibitor of…CertaraFebruary 1, 2012
Exposure-response Relationship of AMG 386 in Combination with Weekly Paclitaxel in Recurrent Ovarian Cancer and Its Implication for Dose Selection Publication Exposure-response Relationship of AMG 386 in Combination with Weekly Paclitaxel in Recurrent Ovarian Cancer and Its Implication for Dose Selection The purpose of this study was to characterize exposure–response relationships of AMG 386 in a…CertaraJanuary 1, 2012
Therapeutic Index of Anticoagulants for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose-response Meta-analysis Publication Therapeutic Index of Anticoagulants for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose-response Meta-analysis Information on the comparative effectiveness of drugs is crucial for drug development decisions, in addition…CertaraDecember 1, 2011
Pharmacokinetics of SN2310, an Injectable Emulsion that Incorporates a New Derivative of SN-38 in Patients with Advanced Solid Tumors Publication Pharmacokinetics of SN2310, an Injectable Emulsion that Incorporates a New Derivative of SN-38 in Patients with Advanced Solid Tumors SN2310 is an injectable emulsion composed of vitamin E, a succinate derivative, as well as…CertaraOctober 1, 2011
In Vitro-In Vivo Extrapolation of CYP2C8-catalyzed Paclitaxel 6a-hydroxylation: Effects of Albumin on In Vitro Kinetic Parameters and Assessment of Interindividual Variability in Predicted Clearance Publication In Vitro-In Vivo Extrapolation of CYP2C8-catalyzed Paclitaxel 6a-hydroxylation: Effects of Albumin on In Vitro Kinetic Parameters and Assessment of Interindividual Variability in Predicted Clearance This study aimed to characterize the effects of bovine serum albumin (BSA) on the kinetics…CertaraAugust 1, 2011
Metabolism of [D10]Phenanthrene to Tetraols in Smokers for Potential Lung Cancer Susceptibility Assessment: Comparison of Oral and Inhalation Routes of Administration Publication Metabolism of [D10]Phenanthrene to Tetraols in Smokers for Potential Lung Cancer Susceptibility Assessment: Comparison of Oral and Inhalation Routes of Administration Polycyclic aromatic hydrocarbons (PAHs) are believed to be among the causative agents for lung cancer…CertaraJuly 1, 2011
Systematic Review: Diagnostic Accuracy of Clinical Decision Rules for Venous Thromboembolism in Elderly Publication Systematic Review: Diagnostic Accuracy of Clinical Decision Rules for Venous Thromboembolism in Elderly Physicians committed to the care of elderly patients are challenged with the diagnosis of venous…CertaraApril 1, 2011
Development of a Modeling Framework to Simulate Efficacy Endpoints for Motesanib in Thyroid Cancer Patients Publication Development of a Modeling Framework to Simulate Efficacy Endpoints for Motesanib in Thyroid Cancer Patients To develop a modeling framework that simulates clinical endpoints (objective response rate and progression-free survival)…CertaraNovember 1, 2010
Population Pharmacokinetic/Pharmacodynamic Modeling for the Time Course of Tumor Shrinkage by Motesanib in Thyroid Cancer Patients Publication Population Pharmacokinetic/Pharmacodynamic Modeling for the Time Course of Tumor Shrinkage by Motesanib in Thyroid Cancer Patients To develop a population pharmacokinetic/pharmacodynamic model describing the relationship between motesanib exposure and tumor response…CertaraNovember 1, 2010