A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group.

@article{Guo2010ARO,
  title={A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group.},
  author={Jeff J. Guo and Swapnil Pandey and John Doyle and Boyang Bian and Yvonne Lis and Dennis W. Raisch},
  journal={Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research},
  year={2010},
  volume={13 5},
  pages={657-66}
}
OBJECTIVE Although regulatory authorities evaluate the risks and benefits of any new drug therapy during the new drug-approval process, quantitative risk-benefit assessment (RBA) is not typically performed, nor is it presented in a consistent and integrated framework when it is used. Our purpose is to identify and describe published quantitative RBA methods for pharmaceuticals. METHODS Using MEDLINE and other Internet-based search engines, a systematic literature review was performed to… CONTINUE READING

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  • R Lea, PJ Whorwell
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