The Process Quality Control and Key Technology of Post-Marketing Clinical Safety Evaluation of Chinese Medical Injection (Draft Report for Comment)
10.11842/wst.2016.12.010
- VernacularTitle:中药注射剂上市后临床安全性评价研究的过程质量控制技术规范(征求意见稿)
- Author:
Wenke ZHENG
;
Junhua ZHANG
;
Jingbo ZHAI
;
Hui WANG
;
Chunxiang LIU
;
Jingtian REN
;
Xiaoxi DU
;
Baohe WANG
;
Yuhong HUANG
- Keywords:
Traditional Chinese medical injection;
clinical safety evaluation;
quality control;
key technology
- From:
World Science and Technology-Modernization of Traditional Chinese Medicine
2016;18(12):2088-2092
- CountryChina
- Language:Chinese
-
Abstract:
At present,the various levels of safety evaluations of traditional Chinese medical (TCM) injections were in force in post-marketing clinical researches,while the process quality is guaranteed with difficulty.Therefore,it is requisite to call for technical guidance.By drawing lessons from the international experience of drug marketing safety evaluation and the related methods,we proposed the key techniques of quality control for clinical safety evaluation of TCM injections from the three aspects:preparation,implementation and summarization of researches,combining with the characteristics of TCM injections.The key techniques contained some scientific problems,ethics,publicity,data management,statistical analysis,specification report,etc.This paper comprehensively introduced the requisite technologies and methods over research quality,laying a foundation for the studies of post-marketing clinical safety evaluation of TCM injections.
