ArticleDrug design, development and therapy2026
A Physiologically-Based Pharmacokinetic Model to Predict Posaconazole Suspension Exposure and Optimize Dosing Strategy in Pediatric Hematology Patients: Incorporating the Impact of Food Intake.
Article in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Mean Exposure Does Not Validate Target Attainment Predictions in Children: A Comment on the Study by Wu et al [Letter].Drug design, development and therapy · 2026Article
- Mean Exposure Does Not Validate Target Attainment Predictions in Children [Response to Letter].Drug design, development and therapy · 2026Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: This study aimed to develop and validate a physiologically based pharmacokinetic (PBPK) model for posaconazole oral suspension in pediatric hematology patients to predict systemic exposure and optimize dose regimens that incorporate food intake. Methods: A PBPK model was established and validated in adults. The model was then extrapolated to pediatric patients by integrating age-specific physiological parameters. The pediatric model was validated using published data and local therapeutic drug monitoring results. The validated model was employed to simulate posaconazole exposure across different age groups, dosing regimens, and meal conditions. Results: The adult PBPK model showed good predictability, with fold errors within 0.5-2.0 and a geometric mean fold error < 2.0. Sensitivity analysis identified the bile salt solubilization ratio, gastric pH, and hepatic UGT1A4 as critical determinants. The pediatric model accurately predicted plasma concentrations, with a mean absolute prediction error of 12.3%. Simulations revealed that achieving prophylactic trough concentration (C Conclusion: This study successfully developed and validated a PBPK model for posaconazole suspension in pediatric hematology patients, which could serve as a supportive in silico tool for model-informed dose optimization in this population. Further prospective clinical validation is still required to support its real-world dosing decision application.
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