ArticleDrug design, development and therapy2025
Development and Validation of a Population Pharmacokinetics Model of Perampanel for Pediatric Epilepsy Patients for Optimized Dosing.
Article in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Perampanel exhibits substantial interindividual variability, and pharmacokinetic data in pediatric patients are scarce. The aim of this study was to develop a population pharmacokinetic (PPK) model to optimize the dosing of perampanel in children with epilepsy. Methods: The PPK model was developed via a nonlinear mixed-effects modeling approach, utilizing a dataset comprising 454 plasma concentrations of perampanel obtained from 151 pediatric patients with epilepsy, 120 (79.5%) of whom were aged < 12 years. Goodness-of-fit plots and bootstrap analysis were employed to evaluate the final model. Monte Carlo simulations were utilized to suggest perampanel dosing strategies using a reference plasma concentration range of 100-1000 ng/mL. Results: In the final PPK models of perampanel, linear centralized age, coadministration of oxcarbazepine (OXC), carbamazepine (CBZ), and valproic acid (VPA) were covariates of clearance (CL/F), and log-transformed body weight was a covariate of the apparent distribution volume (V). The CL/F was estimated via the formula CL/F=0.177*((age+10)/8.8) Conclusion: A reliable perampanel PPK model for pediatric patients was successfully developed. This result could be helpful for dosing optimization in pediatric patients receiving perampanel, especially those aged under 12 years.
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