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Clin Pharmacol Ther. 2011 Feb;89(2):179-82. doi: 10.1038/clpt.2010.290.

Refining the benefit-risk framework for the assessment of medicines: valuing and weighting benefit and risk parameters.

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CMR International Institute for Regulatory Science, London, UK.

Erratum in

  • Clin Pharmacol Ther. 2011 Jun;89(6):928.
  • Clin Pharmacol Ther. 2012 Jan;91(1):150. Levitan, B S [added].


A common framework is necessary for the transparent articulation of the benefits and risks of a therapeutic product across disparate stakeholders. The assignment of value and weighting to each component parameter presents challenges deriving from different stakeholder objectives, methods, and perspectives. Building on prior experiences with a validated framework approach, this forum focused on identifying challenges and approaches to the assignment of values and weightings using a case study applied to a hypothetical medicinal product.

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