Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs Publication Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs Concentration-QT (C-QT) modeling has been conducted for multiple compounds at various stages of development in…CertaraNovember 1, 2009
Model-based Prediction of Phase 3 Overall Survival in Colorectal Cancer on the Basis of Phase 2 Tumor Dynamics Publication Model-based Prediction of Phase 3 Overall Survival in Colorectal Cancer on the Basis of Phase 2 Tumor Dynamics We developed a drug-disease simulation model to predict antitumor response and overall survival in phase…CertaraSeptember 1, 2009
On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies: Toward a New Paradigm to Design and Evaluate Phase 2 Studies Publication On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies: Toward a New Paradigm to Design and Evaluate Phase 2 Studies Drug-independent models that link biomarker response to clinical end points are critical to support early…CertaraAugust 1, 2009
Pharmacokinetic Analysis of Capsaicin After Topical Administration of a High-concentration Capsaicin Patch to Patients With Peripheral Neuropathic Pain Publication Pharmacokinetic Analysis of Capsaicin After Topical Administration of a High-concentration Capsaicin Patch to Patients With Peripheral Neuropathic Pain Capsaicin, a pungent compound in chili peppers, is a highly selective agonist for the transient…CertaraAugust 1, 2009
Assessing the Efficiency of Mixed Effects Modeling in Quantifying Metabolism-based Drug-drug Interactions: Using In Vitro Data as an Aid to Assess Study Power Publication Assessing the Efficiency of Mixed Effects Modeling in Quantifying Metabolism-based Drug-drug Interactions: Using In Vitro Data as an Aid to Assess Study Power The clinical assessment of metabolic drug-drug interactions (mDDI) may involve population-based pharmacokinetic (POPPK) assessment as…CertaraJuly 1, 2009
Population-based Mechanistic Prediction of Oral Drug Absorption Publication Population-based Mechanistic Prediction of Oral Drug Absorption The bioavailability of drugs from oral formulations is influenced by many physiological factors including gastrointestinal…CertaraJune 1, 2009
Population Pharmacokinetics of Intravenous Pantoprazole in Pediatric Intensive Care Patients Publication Population Pharmacokinetics of Intravenous Pantoprazole in Pediatric Intensive Care Patients What is already known about this subject The use of intravenous pantoprazole, a proton pump…CertaraFebruary 1, 2009
Pain Relief Model for a COX-2 Inhibitor in Patients with Postoperative Dental Pain Publication Pain Relief Model for a COX-2 Inhibitor in Patients with Postoperative Dental Pain The aim of this study was to develop a pain relief model for a cyclooxygenase…CertaraJuly 1, 2008
Predictive Population Pharmacokinetic/Pharmacodynamic Model for a Novel COX-2 Inhibitor Publication Predictive Population Pharmacokinetic/Pharmacodynamic Model for a Novel COX-2 Inhibitor The objectives of these analyses were to (1) develop a population pharmacokinetic/pharmacodynamic model for a…CertaraMarch 1, 2007
Development of a Predictive Pharmacokinetic Model for a Novel Cyclooxygenase-2 Inhibitor Publication Development of a Predictive Pharmacokinetic Model for a Novel Cyclooxygenase-2 Inhibitor A predictive population pharmacokinetic model was developed for a novel cyclooxygenase-2 (COX-2) inhibitor CS-706, using…CertaraMay 1, 2006