The ISoP Standards and Best Practices Committee
The mission of the International Society of Pharmacometrics (ISoP) Standards and Best Practices Committee is…
CertaraJune 1, 2014
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
What Can We Learn from Dose Normalization?
Dose normalization is a common calculation performed with pharmacokinetic parameters. The general process is to…
CertaraMay 19, 2014
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
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
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
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
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
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
