Publication: British Journal of Clinical Pharmacology
Abstract
Pharmacokinetic data on oral vinorelbine in children are critically needed given the paucity of pediatric-specific dosing information for this chemotherapy agent. This multicenter Phase II study characterized oral vinorelbine pharmacokinetics in 36 children (ages 6-17) with recurrent or progressive primary low-grade glioma, using non-compartmental analysis in Phoenix WinNonlin and multivariate regression to assess covariate effects. Body surface area was found to significantly influence both clearance and volume of distribution, and children showed lower drug exposure (AUC) than adults at comparable doses. The findings suggest higher vinorelbine doses may be necessary for children with low-grade glioma, providing a foundation for further concentration-response studies in this population.
Author(s): Hamimed M, Gattacceca F, André N, Tresch‑Bruneel E, Probst A, Chastagner P, Pagnier A, De Carli E, Entz‑Werlé N, Grill J, Aerts I, Frappaz D, Bertozzi‑Salamon AI, Solas C, Leblond P
Published: 2021 年 12 月 13 日
Phoenix WinNonlin: Pediatric-Specific PK Data
Phoenix WinNonlin's non-compartmental analysis filled a pediatric dosing data gap for oral vinorelbine in this low-grade glioma study. As part of a Phoenix platform built on a validated, secure foundation, Phoenix WinNonlin can be paired with AI PK Reports to turn an analysis into a complete PK document in minutes rather than days.
