Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (7): 649-654.
DOI: 10.19803/j.1672-8629.2021.07.12

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Current Research on Quantitative Drug Benefit-Risk Assessment Methods and Its Englightenment

GUO Zhijian, HU Fangyuan, ZHENG Yi, LIANG Jizhou, XU Jinfang, GUO Xiaojing, YE Xiaofei, HE Jia*   

  1. Department of Medical Statistics, Faculty of Medical Services, Naval Medical University, Shanghai 200433, China
  • Received:2020-06-19 Online:2021-07-15 Published:2021-07-23

Abstract: Objective To introduce the basic principles and latest developments of current quantitative drug benefit-risk assessment methods. Methods Current guidelines for drug benefit-risk assessment were consulted while domestic and foreign literature on quantitative drug benefit-risk assessment methods was retrieved to conduct a literature review. Results Several well-grounded quantitative benefit-risk assessment methods were outlined. The current applications of quantitative benefit-risk assessment methods of drugs were analyzed and the developments of quantitative assessment methods were explored. Conclusion There is no specific consensus on the selection and use of quantitative drug benefit-risk assessment methods. The relatively novel methods have not been widely used and need to be verified and confirmed in the real drug benefit-risk assessment context.

Key words: drug, quantitative, benefit-risk assessment, method, adverse drug reaction

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