Pharmacokinetic study methodology in compound Chinese drug development
10.13699/j.cnki.1001-6821.2015.16.034
- VernacularTitle:中药复方新药研发中的药代动力学研究方法学
- Author:
Jing-Feng BI
1
;
Bo-Hua YAN
;
Feng DUAN
;
Zhen-Man WEI
;
Wen-Tao XU
;
Jun-Yuan TAN
;
Zhen-Zhen ZHU
;
Ben-Chao CHEN
Author Information
1. 中国人民解放军第302 医院 新药临床试验中心
- Keywords:
pharmacokinetics;
compound Chinese medicine;
re-evualation
- From:
The Chinese Journal of Clinical Pharmacology
2015;(16):1671-1673,1691
- CountryChina
- Language:Chinese
-
Abstract:
This study discussed whether the current pharmacokinetic study method of compound Chinese medicine could meet its research ob-jectives in drug development process.The conclusion were that, firstly, because the single or multiple active ingredient often do not represent the true effect of compound Chinese medicine, its findings may be biased. Secondly, drug accumulation method, pharmacological effect method, serum pharmacological method and integration of multi-effect component classifier method often draw pharmacokinetic results by pharmacodynamic study with thrust reversers method, but these methods can not accurately reflect the true pharmacokinetics in vivo.It might be more clinical value to make pharmacodynamic studies with pharmacodynamic markers.
