P10-drugs for half the world : paediatric clinical pharmacology using Adapt® in paediatric patients : pharmacokinetic modelling for Lamotrigine

Abstract

It is estimated that around 70 % of medicinal products used in paediatric population have never been specifically evaluated for use in that age group. There is still a lack of models that will allow accurate predictions of drug levels in these populations. This is of particular importance in a chronic neurological condition such as epilepsy. In this study, a sparse data model, using AdaptÒ software was developed for lamotrigine in a group of paediatric patients. Plasma lamotrigine levels in 20 paediatric patients (mean ± S.D., age 8.85 ± 3.47 years and weight, 32.22 ±20.81 kg) were measured. The pharmacokinetic parameters in the four groups (lamotrigine alone, with valproate, with carbamazepine, and with clonazepam) were estimated. The only significant difference (P < 0.05)was obtained between the four groups in the case of estimated volume of distribution, predicated minimum plasma concentration, and area under the curve. [excerpt]