Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (5): 286-289.

• Orginal Article • Previous Articles     Next Articles

Brief Analysis of Foreign Quantitative Risk-Benefit Assessing Method of Medicines

LI Shan1, XU Yan2, YANG Yue1, *   

  1. 1 School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016,China;
    2 Center for ADR monitoring of Guangdong, Guangdong Guangzhou 510080, China
  • Received:2011-11-28 Online:2012-05-10 Published:2015-08-10

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Abstract: Objective To analyze and compare the existed medicine risk-benefit assessment methods and provide suggestions to our medicine risk-benefit assessment. MethodsLiterature study and comparative study were used to analyze and compare the foreign materials. ResultsFDA and EMEA has already attached much importance to medicine risk-benefit assessment, and now each of the existed risk-benefit assessment methods has its own strengthness and weakness. ConclusionRegulatory agencies should try to study and explore a standard method that can apply to the whole life period of medicines.

Key words: medicine risk-benefit, assessment method