Applications of Linking PBPK and PD Models to Predict the Impact of Genotypic Variability, Formulation Differences, Differences in Target Binding Capacity and Target Site Drug Concentrations on Drug Responses and Variability Publication Applications of Linking PBPK and PD Models to Predict the Impact of Genotypic Variability, Formulation Differences, Differences in Target Binding Capacity and Target Site Drug Concentrations on Drug Responses and Variability This study aimed to demonstrate the added value of integrating prior in vitro data and…CertaraNovember 26, 2014
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
A Pharmacokinetic/Viral Kinetic Model to Evaluate the Treatment Effectiveness of Danoprevir Against Chronic HCV Publication A Pharmacokinetic/Viral Kinetic Model to Evaluate the Treatment Effectiveness of Danoprevir Against Chronic HCV CertaraOctober 16, 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
Understanding the Effect of the HCV Polymerase Inhibitor Mericitabine on Early Viral Kinetics in the Phase 2 JUMP-C and PROPEL Studies Publication Understanding the Effect of the HCV Polymerase Inhibitor Mericitabine on Early Viral Kinetics in the Phase 2 JUMP-C and PROPEL Studies CertaraAugust 21, 2014