Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (12): 752-754.

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Multiple Criteria Decision Analysis-Based Methodologies for Pharmaceutical Product Risk-Benefit Assessment

XIONG Wei-yi, DONG Duo*   

  1. Center for Drug Reevaluation, CFDA, Beijing 10045, China
  • Received:2017-08-28 Revised:2018-01-19 Online:2017-12-20 Published:2018-01-19

Abstract: Benefit-risk assessment is a critical issue throughout the whole life-cycle for pharmaceutical products. The importance of quantitative assessment has arisen. Assessment methodologies based on multiple criteria decision analysis (MCDA) are highly recommended by international regulatory authorities. In 2016, a task force from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) published an operational framework of MCDA application in health decisions and elaborated the key steps involved in implementing MCDA-based assessments. This paper aims to introduce MCDA and ISPOR framework to provide references to similar practices in China.

Key words: multi-criteria decision analysis, benefit-risk assessment

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