Individualized dosage study of vitamin D3 based on physiologically-based pharmacokinetic modeling
10.12092/j.issn.1009-2501.2025.08.007
- VernacularTitle:基于生理药代动力学模型的维生素D个体化给药方案研究
- Author:
Yuanyuan WEI
1
;
Tao MA
;
Yuezhou TANG
;
Hubo LI
;
Xiaoyu TIAN
;
Yunjie DANG
;
Xu ZHOU
Author Information
1. 河北医科大学药学院,石家庄 050017,河北
- Publication Type:Journal Article
- Keywords:
vitamin D3;
PK-Sim?;
PBPK;
pharma-cokinetics;
goodness of fit;
dose prediction
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2025;30(8):1067-1075
- CountryChina
- Language:Chinese
-
Abstract:
AIM:To establish a physiologically-based pharmacokinetic(PBPK)model for vitamin D in adults,aiming to provide guidance for the ratio-nal clinical use of vitamin D in individuals with vita-min D deficiency.METHODS:Relevant literature and databases were reviewed to obtain the physi-cochemical properties and pharmacokinetic param-eters of vitamin D3.The PBPK model for adult whole-body vitamin D was constructed,optimized,and predicted using PK-Sim? software.The model's predictive performance was evaluated using confi-dence intervals,goodness of fit,and fold error(FE).The effectiveness of commonly used clinical dosing regimens was assessed based on the final opti-mized model,and personalized dosing recommen-dations were provided.RESULTS:The established adult whole-body PBPK model for vitamin D had a goodness of fit R2 of 0.961,approaching 1,and the FE values for AUC0-∞ and Cmax were both within the range of 0.5 and 2,indicating that the constructed PBPK model possesses good data predictive capa-bility.CONCLUSION:A successful PBPK model for oral vitamin D3 in adults has been established,showing good predictive performance for single oral doses of vitamin D3.Single oral doses of vita-min D3(7 500 μg and 15 000 μg)are safe and effec-tive dosing regimens for improving vitamin D insuf-ficiency or deficiency in Asian adults.Regular moni-toring of vitamin D levels before and during treat-ment is recommended to achieve the optimal out-comes of personalized therapy.
