Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban.

ABSTRACT:

Background

Venous thromboembolism has been increasingly recognised as a clinical problem in the paediatric population. Guideline recommendations for antithrombotic therapy in paediatric patients are based mainly on extrapolation from adult clinical trial data, owing to the limited number of clinical trials in paediatric populations. The oral, direct Factor Xa inhibitor rivaroxaban has been approved in adult patients for several thromboembolic disorders, and its well-defined pharmacokinetic and pharmacodynamic characteristics and efficacy and safety profiles in adults warrant further investigation of this agent in the paediatric population.

Objective

The objective of this study was to develop and qualify a physiologically based pharmacokinetic (PBPK) model for rivaroxaban dos

SUBMITTER: Willmann S 

PROVIDER: S-EPMC3889826 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature