Objective To find out more about foreign benefit-risk assessment methods of drugs and to provide reference for related work in China via a comparison of their advantages and disadvantages.Methods Foreign literature and other publicly available information on benefit-risk assessment methods for pharmaceuticals were reviewed and analyzed.Results Seven qualitative methods and 18 quantitative methods were identified that could be used for regulatory decision-making from theories on research abroad,and related cases were collected for adaptive research,as well as,recommendations to promote benefit-risk evaluation methodology for medicines in China were made.Conclusion Some of the methods are highly applicable.It is recommended that the framework of benefit-risk assessment of drugs be specified in China,quantitative evaluation methods be established within a qualitative evaluation framework,the standard for comparison of benefits and risks be set,and a comprehensive data collection network be constructed in China.
关键词
药物警戒/药品/获益/风险/评价/药品不良反应
Key words
pharmacovigilance/drug/benefit/risk/assessment/adverse drug reactions
维普
万方数据