Extrapolation of a Brivaracetam Exposure-Response Model from Adults to Children with Focal Seizures.

ABSTRACT:

Introduction

Prediction of brivaracetam effects in children was obtained by scaling an existing adult pharmacokinetic/pharmacodynamic (PK/PD) model for brivaracetam to children, using an existing population PK model for brivaracetam in children. The scaling was supported by estimating the change from adults to children in the concentration-effect relationship parameters for levetiracetam, a compound interacting with the same target protein (synaptic vesicle protein SV2A).

Methods

The existing adult PK/PD model for brivaracetam was applied to a combined adult-pediatric dataset of levetiracetam. This model was then used to predict the effective oral twice-daily dose of brivaracetam in children aged ≥4 to <16 years as adjunctive treatment for focal (partial onset) seizures. The

SUBMITTER: Schoemaker R 

PROVIDER: S-EPMC5999174 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature