Publication: Current Oncology
Abstract
Tamibarotene is a synthetic retinoid being investigated for pediatric and young adult patients with recurrent or refractory solid tumors, following an earlier Phase I safety study. This analysis used data from that Phase I trial, encompassing 109 samples from 22 patients receiving tamibarotene across a range of doses, to construct a population pharmacokinetic model using Phoenix NLME. Body surface area was identified as a significant covariate for clearance and both central and peripheral volumes of distribution in the final two-compartment model, which showed satisfactory predictive accuracy on validation. This population pharmacokinetic model provides a foundation for more precisely dosing tamibarotene in future pediatric and young adult oncology studies.
Author(s): Azechi T, Fukaya Y, Nitani C, Hara J, Kawamoto H, Taguchi T, Yoshimura K, Sato A, Hattori N, Ushijima T, Kimura T
Published: 2024 年 11 月 14 日
Phoenix NLME:A Foundation for Pediatric Dosing
Phoenix NLME built the first population PK model for this investigational retinoid, identifying body surface area as the key covariate for future pediatric oncology dosing. Within a Phoenix platform used by 100% of the top 20 pharma companies, Phoenix NLME can be paired with Model Designer to select, configure, and simulate models directly in the browser, guided by an AI assistant.



