Causality Assessment of Adverse Drug Reactions and Its Guiding Significance for Post-evaluation of Chinese Patent Medicine
- VernacularTitle:不良反应因果关系判定方法对上市后中成药安全性评价的指导意义
- Author:
Shiqi CHEN
1
;
Rui ZHENG
;
Youping LI
;
S.W.Kwong JOEY
;
Hongcai SHANG
Author Information
- Keywords: ADRs; causality assessment; relevance analysis; chinese patent medicine; safety evaluation
- From: World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(10):1729-1733
- CountryChina
- Language:Chinese
- Abstract: This study introduces 5 methods of causality assessment of adverse drug reactions (ADRs) domestic and overseas. According to the assessment of ministry of public health of China, the key points about the relevance analysis have been illuminated for the post-evaluation of Chinese patent medicine. Under the guidance of the causality assessment, we should describe the ADR reports in detail and further detect the accurate ADR warning signals. In order to supplement the ADR information, more researches concerning the ADR mechanism should be fully explored.