Improving the Assessment of Heart Toxicity for All New Drugs Through Translational Regulatory Science
Fourteen drugs have been removed from the market worldwide because they cause torsade de pointes.…
Certara2014 年 5 月 1 日
Changes in Individual Drug-independent System Parameters during Virtual Pediatric Pharmacokinetic Trials: Introducing Time-varying Physiology into a Pediatric PBPK Model
Although both POPPK and physiologically based pharmacokinetic (PBPK) models can account for age and other covariates within…
Certara2014 年 5 月 1 日
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…
Certara2014 年 4 月 1 日
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…
Certara2014 年 4 月 1 日
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…
Certara2014 年 3 月 26 日
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…
Certara2014 年 3 月 5 日
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…
Certara2014 年 3 月 1 日
Electrocardiographic Data Quality in Thorough QT/QTc Studies
Most drugs with systemic bioavailability have to undergo a thorough QT (TQT) study, which includes…
Certara2014 年 3 月 1 日
In Vitro-In Vivo Extrapolation of Drug-induced Proarrhythmia Predictions at the Population Level
Drug cardiotoxicity is a serious issue for patients, regulators, pharmaceutical companies and health service payers…
Certara2014 年 3 月 1 日
