Exploration of early food effect study of innovative drugs based on physiologically-based pharmacokinetic absorption model
10.12092/j.issn.1009-2501.2021.12.013
- Author:
Miao ZHANG
1
;
Qian LIU
1
;
Xueting YAO
1
;
Dongyang LIU
1
Author Information
1. Drug Clinical Trial Center, Peking University Third Hospital
- Publication Type:Journal Article
- Keywords:
Clinical trial design;
Food effect;
Physiologically-based pharmacokinetic absorption model
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2021;26(12):1426-1429
- CountryChina
- Language:Chinese
-
Abstract:
Since the impact of food on innovative drugs exposure will increase the risk of evaluation failures for safety and effectiveness, food effect study is routinely completed before multiple ascending dose (MAD) trials for innovative drugs. The prediction performance of physiologically-based pharmacokinetic absorption model (absorption PBPK model) in the application of food effect prediction has improved, we proposed a new strategy to explore food effect based on the absorption PBPK model. Based on the accurate prediction by absorption PBPK model, the food effect studies for qualified innovative drugs would be nested in MAD clinical trials to intend replacing the early independent food effect study. That would be promising to reduce costs and time for drug development, and also to provide the template for early food effect study in China.