Establishment and prediction of physiologically based pharmacokinetic model of theophylline in premature infants using GastroPlus simulation technology
10.13699/j.cnki.1001-6821.2018.05.012
- VernacularTitle:用GastroPlus构建茶碱的早产儿生理药代动力学模型研究
- Author:
Xiang-Bo GAO
1
;
Shao-Qing NI
;
Zhou-Hong JIANG
;
Jian-Zhong SHENTU
;
Lu-Shan YU
Author Information
1. 浙江大学 医学院 附属儿童医院药剂科
- Keywords:
theophylline;
premature infant;
physiologically based pharmacokinetic model;
GastroPlus
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(5):528-531
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a physiologically based pharmacokinetic (PBPK) model and predict the pharmacokinetics (PK) of theophylline in premature infants.Methods Collected the drug-specific properties and clinical trial data of theophylline from published literatures,theophylline PBPK model was established by GastroPlus simulation technology.The accuracy and applicability of model were verified in different type populations.It was also verified to predict premature population.The model was used to predict the PK of theophylline in each preterm after parameter optimization.Results It was verified with good accuracy and applicability.The area under curve AUCsim/AUCobs ratio was 0.85-1.15 and the coefficient of determination (R2) was greater than 0.85.It's less errors and good fit of the simulated value and observed data in each preterm.Conclusion The PBPK model of theophylline established by GastroPlus can reflect the PK process of theophylline in premature infants and provide a reference for theophylline individualized medication.It will be able to improve the model accuracy by the supplement of the important physiological and anatomical data of premature and infants in China.
