Ophthalmic medicine regulatory approvals through the European Centralised Procedure, 1999–2017: Clinical efficacy considerations
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DOI: 10.1177/1120672119830932
Abstract: Objectives: Regulatory approval of new medicines requires a thorough assessment of the potential clinical benefits and risks. Study end-points are expected to demonstrate a clinically relevant treatment effect that will translate into direct patient benefits.… read more here.
Keywords: medicine; 1999 2017; clinical efficacy; end points ... See more keywords