A quantitative approach to benefit-risk assessment of medicines - part 1: the development of a new model using multi-criteria decision analysis.

Abstract

PURPOSE One of the most important uses of benefit-risk assessment pertains to approval of new medicines by regulatory authorities and the subsequent review of these products during their life-cycle when new safety and/or efficacy data becomes available. At present, there exist no validated, well-accepted models for benefit-risk assessment that have the… (More)

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