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
Precision Criteria to Derive Sample Size When Designing Pediatric Pharmacokinetics Studies: Which Measure of Variability Should be Used?
A new approach for calculation of sample size in pediatric clinical pharmacokinetic studies was suggested based on desired precision for a pharmacokinetic parameter…
Certara2014 年 3 月 1 日
Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers
Axitinib is a potent and selective second generation inhibitor of vascular endothelial growth factor receptors…
Certara2014 年 2 月 21 日
A Model-based Meta-analysis to Compare Efficacy and Tolerability of Tramadol and Tapentadol for the Treatment of Chronic Non-malignant Pain
Pain is a major symptom in many medical conditions which can be relieved thanks to…
Certara2014 年 2 月 13 日
A Systems Pharmacology Perspective on the Clinical Development of Fatty Acid Amide Hydrolase Inhibitors for Pain
The level of the endocannabinoid anandamide is controlled by fatty acid amide hydrolase (FAAH). In…
Certara2014 年 1 月 15 日
The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?
A collaboration between the Consortium for Innovation and Quality in Pharmaceutical Development and the Cardiac…
Certara2014 年 1 月 1 日
Incorporating Target Shedding into a Minimal PBPK-TMDD Model for Monoclonal Antibodies
Shedding of a pharmacological target from cells, giving rise to a soluble target that can also bind therapeutic proteins, is…
Certara2014 年 1 月 1 日
Anatomical, Physiological and Metabolic Changes with Gestational Age During Normal Pregnancy: A Database for Parameters Required in Physiologically-based Pharmacokinetic Modeling
Pregnancy is associated with considerable changes in the physiological, anatomical and biochemical attributes in women.…
Certara2013 年 12 月 13 日
Bottom-up Modeling and Simulation of Tacrolimus Clearance: Prospective Investigation of Blood Cell Distribution, Sex and CYP3A5 Expression as Covariates and Assessment of Study Power
The objectives were to investigate the ability of population-based in vitro-in vivo extrapolation (IVIVE) to…
Certara2013 年 12 月 1 日
