Notes
including all PSUR-related costs for the pharmaceutical industry and regulatory agencies during the 1995−2009 period, assuming a cost between €6000 and €28 000 (2006 values) for one PSUR depending on the number of adverse drug reaction cases (< 100 to > 500)
Reference
Bouvy JC, et al. The Cost-Effectiveness of Periodic Safety Update Reports for Biologicals in Europe. Clinical Pharmacology and Therapeutics : 3 Apr 2013. Available from: URL: http://dx.doi.org/10.1038/clpt.2013.13
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PSURs for biologicals worth their high costs?. PharmacoEcon Outcomes News 676, 5 (2013). https://doi.org/10.1007/s40274-013-0316-7
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DOI: https://doi.org/10.1007/s40274-013-0316-7