Population Pharmacokinetics Analysis of Vigabatrin in Adults and Children with Epilepsy and Children with Infantile Spasms Publication Population Pharmacokinetics Analysis of Vigabatrin in Adults and Children with Epilepsy and Children with Infantile Spasms Vigabatrin is an inhibitor of γ-aminobutyric acid transaminase. The purpose of these analyses was to…CertaraNovember 1, 2014
The Rise of Systems Pharmacology in Drug Discovery and Development Publication The Rise of Systems Pharmacology in Drug Discovery and Development CertaraOctober 1, 2014
Lost in Centrifugation: Accounting for Transporter Protein Losses in Quantitative Targeted Absolute Proteomics Publication Lost in Centrifugation: Accounting for Transporter Protein Losses in Quantitative Targeted Absolute Proteomics In drug development, considerable efforts are made to extrapolate from in vitro and preclinical findings…CertaraOctober 1, 2014
Time Course of Bone Mineral Density Changes with Denosumab Compared with Other Drugs in Postmenopausal Osteoporosis: A Dose-response-based Meta-analysis Publication Time Course of Bone Mineral Density Changes with Denosumab Compared with Other Drugs in Postmenopausal Osteoporosis: A Dose-response-based Meta-analysis Our objective was to compare the time course of bone mineral density (BMD) changes at…CertaraOctober 1, 2014
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