Optimization of gabapentin dosage in pediatric patients with renal impairment: a physiologically based pharmacokinetic modeling approach.

ABSTRACT:

Background

Gabapentin (GAB) is an adjunctive antiepileptic drug widely used in pediatric patients. However, little is known about its pharmacokinetics in pediatric patients under 3 years old or with renal impairment (RI). To address this, we developed a physiologically based pharmacokinetic (PBPK) model for precise dosing guidance.

Methods

A PBPK model for GAB was first developed in healthy adults using PK-Sim® and then extended to pediatric populations, accounting for age-related physiological changes. For RI simulations, reduced glomerular filtration and tubular secretion were incorporated based on adult RI models.

Results

The PBPK model accurately predicted GAB exposure in adults and children after single and multiple administration (geometric mean fold error <2).

SUBMITTER: Qin X 

PROVIDER: S-EPMC12511071 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature