Construction of Clinical Trial Technological Platform of Traditional Chinese Medicine Live Disease
10.11842/wst.2013.05.010
- VernacularTitle:构建中医肝病新药临床试验研究技术平台探索
- Author:
Tao ZHANG
;
Li HU
;
Kewei SUN
;
Bin CHEN
- Publication Type:Journal Article
- Keywords:
Traditional Chinese medicine;
new drugs;
GCP;
liver disease;
technological platform
- From:
World Science and Technology-Modernization of Traditional Chinese Medicine
2013;(5):852-855
- CountryChina
- Language:Chinese
-
Abstract:
This study was aimed to construct a clinical trial technological platform of traditional Chinese medicine (TCM) live disease in accordance with the international good clinical practice (GCP) standard. Through the con-struction of technological platforms such as clinical new medicine ethics committee of liver disease of TCM, ex-perimental methods, curative effect evaluation, data management, and etc., the clinical evaluation method and in-dex system of new drugs with the curative effect characteristics of liver disease of TCM were established. It was concluded that under the construction of relevant technological platform, an effect evaluation method and index system with TCM diagnosis and treatment characteristics were built . And a key clinical trial technological platform of new drugs of TCM liver disease was established to meet requirements of the international GCP standard.
