Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020
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DOI: 10.1002/cpt.2554
Abstract: Regulatory qualification of biomarkers facilitates their harmonized use across drug developers, enabling more personalized medicine. This study reviews various aspects of the European Medicines Agency’s (EMA’s) biomarker qualification procedure, including frequency and outcome, common challenges,… read more here.
Keywords: qualification procedures; european medicines; biomarker; qualification ... See more keywords