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…
Danielle Pillsbury2013年4月1日
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,…
Danielle Pillsbury2013年3月28日
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.…
Danielle Pillsbury2013年1月1日
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…
Danielle Pillsbury2012年12月26日
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…
Danielle Pillsbury2012年11月1日
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…
Danielle Pillsbury2012年2月1日
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…
Danielle Pillsbury2012年1月1日
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…
Danielle Pillsbury2011年12月1日
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…
Danielle Pillsbury2011年10月1日
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…
Danielle Pillsbury2011年8月1日
