Modeling and Predicting Drug Pharmacokinetics in Patients with Renal Impairment
Current guidance issued by the US FDA to assess the impact of renal impairment on…
Certara2011年3月1日
Resurgence in the Use of Physiologically-based Pharmacokinetic Models in Pediatric Clinical Pharmacology: Parallel Shift in Incorporating the Knowledge of Biological Elements and Increased Applicability to Drug Development and Clinical Practice
This study had two primary aims: (i) To describe an example of the development work…
Certara2011年3月1日
Excretion of the Principal Urinary Metabolites of Phenytoin and Absolute Oral Bioavailability Determined by Use of a Stable Isotope in Patients with Epilepsy
The anticonvulsant properties of phenytoin (PHT) were discovered in 1938. Since then, it has been…
Certara2011年2月1日
Poor Correlation between Urinary Excretion of the Principal Urinary Metabolites of Phenytoin and Absolute Oral Bioavailability Determined by a Stable Isotope Method in Epilepsy Patients
The anticonvulsant properties of phenytoin (PHT) were discovered in 1938. Since then, it has been…
Certara2011年2月1日
Unexpected Effect of Rifampin on the Pharmacokinetics of Linezolid: In Silico and In Vitro Approaches to Explain Its Mechanism
The effect of rifampin on the steady-state pharmacokinetics of linezolid was evaluated in an open-label,…
Certara2011年2月1日
Critique of the Two-fold Measure of Prediction Success for Ratios: Application for the Assessment of Drug-drug Interactions
Current assessment of drug-drug interaction (DDI) prediction success is based on whether predictions fall within a two-fold range of the observed data. This strategy…
Certara2011年2月1日
Applications of Physiologically-based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review
Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can help predict the…
Certara2011年2月1日
Assessment of Algorithms for Predicting Drug-drug Interactions Via Inhibition Mechanisms: Comparison of Dynamic and Static Models
The prediction of drug-drug interactions (DDIs) from in vitro data usually utilizes an average dosing…
Certara2011年1月1日
Modeling Disease Progression in Acute Stroke Using Clinical Assessment Scales
This article demonstrates techniques for describing and predicting disease progression in acute stroke by modeling…
Certara2010年12月1日
Development of a Modeling Framework to Simulate Efficacy Endpoints for Motesanib in Thyroid Cancer Patients
To develop a modeling framework that simulates clinical endpoints (objective response rate and progression-free survival)…
Certara2010年11月1日
