Physiologically based pharmacokinetic modeling for children and its application in pediatric drug research
10.16438/j.0513-4870.2019-0594
- VernacularTitle:儿童生理药代动力学模型及其在儿科药物研究中的应用
- Author:
Xiao-jie ZHENG
1
;
Si-ze LI
2
;
Ya-wen YUAN
2
;
Sha-sha JIN
2
;
Min LI
2
;
Xiao-qiang XIANG
2
Author Information
1. Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
2. School of Pharmacy, Fudan University, Shanghai 201203, China
- Publication Type:Research Article
- Keywords:
pediatric drug;
physiologically based pharmacokinetic modeling;
rug-drug interaction
- From:
Acta Pharmaceutica Sinica
2020;55(1):38-44
- CountryChina
- Language:Chinese
-
Abstract:
Physiologically based pharmacokinetic (PBPK) modeling is an important tool to predict pharmacokinetic or pharmacodynamic profiles in special populations, especially in children and infants where designing and conducting clinical studies is difficult. The application of PBPK modeling can effectively promote the development of pediatric drugs and their clinical use. At present, PBPK modeling of pediatric populations is mainly applied in clinical trial design, drug-drug interaction (DDI) risk assessment, and dose selection in children. This review discusses the advantages of PBPK modeling in pediatric drug research and summarizes how to extrapolate a PBPK model from adults to children. The theoretical basis for pediatric PBPK models, the modelling process and important physiological parameters during the modeling process are introduced. Some successful applications of PBPK modeling in pediatric drug research and development are also presented. This review also analyzes the current limitations and future directions of pediatric PBPK modeling.
