Publication: Drug Design, Development and Therapy
Abstract
Venetoclax, a BCL-2 inhibitor used in pediatric hematologic malignancies, has limited individualized dosing data in Chinese children. This study developed a population pharmacokinetic model from 225 plasma concentrations across 96 Chinese pediatric patients using Phoenix NLME, then examined the relationship between drug exposure and minimal residual disease (MRD) status in a retrospective cohort of 52 acute myeloid leukemia patients. Body surface area and triazole co-administration significantly influenced venetoclax clearance, and higher trough and post-dose concentrations were consistently associated with MRD-negative status in both newly diagnosed and relapsed/refractory patients. This first real-world Chinese pediatric PopPK model supports using therapeutic drug monitoring and model-guided dosing to optimize venetoclax therapy in pediatric AML.
Author(s): Zhao Y, Song X, Zhang L, Zhu Y, Chen J, Gong Y, Luo X, He H, Zhang X, Huang L.
Published: March 20, 2026
Phoenix NLME: Pediatric Population Modeling
Phoenix NLME built the population PK model behind this venetoclax study, linking drug exposure to treatment response in pediatric leukemia patients. As part of a Phoenix platform used by more than 1,600 companies across 60 countries, Phoenix NLME remains the engine behind population PK/PD modeling, combining the flexibility of code with the ease of a guided interface.
