Cardiac Safety Research Consortium: Can the Thorough QT/QTc Study Be Replaced by Early QT Assessment in Routine Clinical Pharmacology Studies? Scientific Update and a Research Proposal for a Path Forward Publication Cardiac Safety Research Consortium: Can the Thorough QT/QTc Study Be Replaced by Early QT Assessment in Routine Clinical Pharmacology Studies? Scientific Update and a Research Proposal for a Path Forward The International Conference on Harmonization E14 guidance for the clinical evaluation of QT/QTc interval prolongation…CertaraSeptember 1, 2014
Deciding on Success Criteria for Predictability of Pharmacokinetic Parameters from In Vitro Studies: An Analysis Based on In Vivo Observations Publication Deciding on Success Criteria for Predictability of Pharmacokinetic Parameters from In Vitro Studies: An Analysis Based on In Vivo Observations Prediction accuracy of pharmacokinetic parameters is often assessed using prediction fold error, i.e., being within 2-, 3-, or…CertaraSeptember 1, 2014
Development of Physiologically-based Pharmacokinetic Model to Evaluate the Relative Systemic Exposure to Quetiapine After Administration of IR and XR Formulations to Adults, Children, and Adolescents Publication Development of Physiologically-based Pharmacokinetic Model to Evaluate the Relative Systemic Exposure to Quetiapine After Administration of IR and XR Formulations to Adults, Children, and Adolescents Quetiapine is an atypical antipsychotic drug with a high permeability, moderate solubility and defined as…CertaraSeptember 1, 2014
Assessment of Tumor Growth Inhibition Metrics to Predict Overall Survival Publication Assessment of Tumor Growth Inhibition Metrics to Predict Overall Survival Modeling and simulation is proposed to support drug development phase transitions in oncology. Longitudinal tumor-size…CertaraAugust 1, 2014
Interaction Between Domperidone and Ketoconazole: Toward Prediction of Consequent QTc Prolongation Using Purely In Vitro Information Publication Interaction Between Domperidone and Ketoconazole: Toward Prediction of Consequent QTc Prolongation Using Purely In Vitro Information We aimed to investigate the application of combined mechanistic pharmacokinetic (PK) and pharmacodynamic (PD) modeling…CertaraAugust 1, 2014
Population Pharmacokinetic Analysis of Dutogliptin, a Selective Dipeptidyl Peptidase-4 Inhibitor Publication Population Pharmacokinetic Analysis of Dutogliptin, a Selective Dipeptidyl Peptidase-4 Inhibitor Dutogliptin is a selective dipeptidyl peptidase-4 inhibitor shown to be efficacious and safe in patients…CertaraJuly 14, 2014
Simulation of Monoclonal Antibody Pharmacokinetics in Humans Using a Minimal Physiologically-based Model Publication Simulation of Monoclonal Antibody Pharmacokinetics in Humans Using a Minimal Physiologically-based Model Compared to small chemical molecules, antibodies and Fc-containing derivatives (mAbs) have unique pharmacokinetic behavior characterized by…CertaraJuly 9, 2014
Application of a Physiologically-based Pharmacokinetic Model to Predict OATP1B1-related Variability in Pharmacodynamics of Rosuvastatin Publication Application of a Physiologically-based Pharmacokinetic Model to Predict OATP1B1-related Variability in Pharmacodynamics of Rosuvastatin Typically, pharmacokinetic-pharmacodynamic (PK/PD) models use plasma concentration as the input that drives the PD model. However, interindividual variability in…CertaraJuly 9, 2014
Model of the Distribution of Diastolic Left Ventricular Posterior Wall Thickness in Healthy Adults and Its Impact on the Behavior of a String of Virtual Cardiomyocytes Publication Model of the Distribution of Diastolic Left Ventricular Posterior Wall Thickness in Healthy Adults and Its Impact on the Behavior of a String of Virtual Cardiomyocytes Correlation of the thickness of the left ventricular posterior wall (LVPWd) with various parameters, including…CertaraJuly 1, 2014
A Re-evaluation and Validation of Ontogeny Functions for CYPs 1A2 and 3A4 Based on In Vivo Data Publication A Re-evaluation and Validation of Ontogeny Functions for CYPs 1A2 and 3A4 Based on In Vivo Data Current cytochrome P450 (CYP) 1A2 and 3A4 ontogeny profiles, which are derived mainly from in…CertaraJuly 1, 2014