Why are PK Parameters Lognormally Distributed?
The statistical analysis of pharmacokinetic parameters is often overlooked and not always well understood. The…
Certara2011 年 2 月 10 日
What are Direct and Indirect Pharmacodynamic Models?
When constructing pharmacodynamic (PD) models, you will often encounter the adjectives “direct” and “indirect” describing…
Certara2011 年 2 月 8 日
What is Modeling and Simulation?
I am currently attending a short conference on modeling and simulation in pediatric clinical pharmacology,…
Certara2011 年 2 月 1 日
Physiologically-based Pharmacokinetic Model for Topotecan in Mice
Topotecan is a chemotherapeutic agent of choice for the second-line treatment of recurrent ovarian cancer.…
Certara2011 年 2 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
Physiologically-based Pharmacokinetics in Drug Development and Regulatory Science
The application of physiologically-based pharmacokinetic (PBPK) modeling is coming of age in drug development and…
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
