Paediatric pharmacokinetic modelling for sparse Lamotrigine data using Adapt®

Abstract

PURPOSE: The paediatric population represents a vulnerable group with developmental, physiological and psychological differences from adults, which makes age and development related research particularly important. It is estimated that between 50 and 90% of medicinal products used in the paediatric population have never been specifically evaluated for use in that age group. Most physicians use ad hoc reasoning in the design of therapeutics and dosage regimens for these drugs in children, as there is still a lack of satisfactory models and software packages that will allow accurate predictions of drug levels with these drugs in these populations. This is of particular importance in a chronic neurological condition such as epilepsy.

METHODS: In this study, the value of a sparse data model, using Adapt® 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 using a novel validated high performance liquid chromatography (HPLC) technique. The pharmacokinetic parameters in the four groups (lamotrigine alone, valproate co-medication group, carbamazepine co-medication group, and clonazepam co-medication group) were estimated in this study using model independent pharmacokinetic equations.

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