1773212818     

Characterizing uncertainty in the assessment of benefits and risks of pharmaceutical products / Denise Caruso and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine

Institute of Medicine (U.S.), [MitwirkendeR]

Institute of Medicine (U.S.). / Forum on Drug Discovery, Development, and Translation, [VeranstalterIn]

[Washington, DC] : Institute of Medicine of the National Academies Press, April 2014

1 online resource (1 PDF file (7 pages)).

Englisch

Includes bibliographical references. - Description based on online resource; title from PDF title page (viewed January 18, 2019)

Elektronische Ressource: Zugang beim Produzenten (Lizenzangabe: Teilweise kostenfrei zugänglich (überwiegender Teil oder ab bzw. vor einem bestimmten Zeitpunkt (Moving Wall) kostenfrei zugänglich))

MeSH: Pharmaceutical Preparations ; Risk Assessment ; Health Communication ; Drug Industry ; Legislation, Drug ; United States ; Congress

On February 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop as the first of a two-part series to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, as well as their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. This brief summary of the workshop provides highlights from the presentations and discussions.