Oncology/Hematology Archives

Publication

Model-based Drug Development in Oncology: What’s Next?

Model-based estimates of tumor growth inhibition (TGI) metrics have the potential to enhance learning in…

CertaraApril 1, 2013

Publication

Axitinib in Metastatic Renal Cell Carcinoma: Results of a Pharmacokinetic and Pharmacodynamic Analysis

Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors 1, 2,…

CertaraMarch 28, 2013

Publication

Autoinhibition of CYP3A4 Leads to Important Role of CYP2C8 in Imatinib Metabolism: Variability in CYP2C8 Activity May Alter Plasma Concentrations and Response

Recent data suggest that the role of CYP3A4 in imatinib metabolism is smaller than presumed.…

CertaraJanuary 1, 2013

Publication

Simulations to Assess Phase 2 Non-inferiority Trials of Different Doses of Capecitabine in Combination with Docetaxel for Metastatic Breast Cancer

A phase II trial in metastatic breast cancer (MBC) (NO16853) failed to show noninferiority (progression-free…

CertaraDecember 26, 2012

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

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

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

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

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

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

Oncology/Hematology

Model-based Drug Development in Oncology: What’s Next?

Axitinib in Metastatic Renal Cell Carcinoma: Results of a Pharmacokinetic and Pharmacodynamic Analysis

Autoinhibition of CYP3A4 Leads to Important Role of CYP2C8 in Imatinib Metabolism: Variability in CYP2C8 Activity May Alter Plasma Concentrations and Response

Simulations to Assess Phase 2 Non-inferiority Trials of Different Doses of Capecitabine in Combination with Docetaxel for Metastatic Breast Cancer

Simulations Using a Drug-disease Modeling Framework and Phase 2 Data Predict Phase 3 Survival Outcome in First-line Non-small Cell Lung Cancer

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

Exposure-response Relationship of AMG 386 in Combination with Weekly Paclitaxel in Recurrent Ovarian Cancer and Its Implication for Dose Selection

Therapeutic Index of Anticoagulants for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose-response Meta-analysis

Pharmacokinetics of SN2310, an Injectable Emulsion that Incorporates a New Derivative of SN-38 in Patients with Advanced Solid Tumors

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

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