Quantitative Evaluation on Adverse Drug Reaction Signal in FDA and Its Illumination
- VernacularTitle:美国食品与药物管理局药品不良反应信号的定量评价方法概述及启示
- Author:
Yuxia BI
;
Chunfu WU
;
Jingyu YANG
- Publication Type:Journal Article
- Keywords:
ADR;
Risk signal;
Date mining;
Monitoring;
Quantitative evaluation
- From:
China Pharmacy
2005;0(18):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To analyze and evaluate the quantitative evaluation of ADR signals in FDA and to provide a reference for ADR evaluation in China. METHODS: By means of literature review,contrasting analysis and data reduction,ADR signal evaluation in FDA was investigated. RESULTS&CONCLUSION: In USA MGPS method is used for the quantitative evaluation of ADR signal, which can earlier obtain ADR signal and effectively promote the risk warning ability of ADR information. This is practical in our country and we should learn from them. Combined with various data analyzing methods, we can set up a high-quality evaluation database for ADR signals. The importance of pharmacoepidemiology and statistics in ADR evaluation should be highly recognized and the methods for ADR signals evaluation should be gradually shifted from qualitative to quantitative evaluation.
