Application of Physiologically Based Pharmacokinetic Modeling of Lamotrigine Using PK-Sim in Predicting the Impact of Drug Interactions and Dosage Adjustment

Objectives To build a lamotrigine (LTG) physiologically based pharmacokinetic (PBPK) model (LTG PBPK) and compare it to the clinical data from South Asian Indian patients use this understand drug interactions of LTG explore optimal doses. Methods Material The PBPK was developed using PK-Sim software platform qualified with plasma concentration an study. European population database chosen as patient setting in software. Physiochemical enzyme kinetic were incorporated literature. Dosing protocols per previous Interaction models for carbamazepine valproate also simulated. Results Most predicted concentration-time profiles at steady-state well within observed concentrations. suitably qualified. interaction used assess impact induction inhibition profile LTG. Conclusions concentrations very similar patients. are applicable predicting can yield appropriate doses be administered.