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
What evidence do we need for biomarker qualification?
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DOI: 10.1126/scitranslmed.aal4599
Abstract: Predictable steps are needed to determine the evidence required for confident use of a biomarker in drug development. Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification—the use of a biomarker… read more here.
Keywords: biomarker qualification; biomarker; evidence need; need biomarker ... See more keywords
Preclinical biomarker qualification
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DOI: 10.1177/1535370217743949
Abstract: Biomarkers are ubiquitously used within drug development programs in both nonclinical species and in humans to assess safety and efficacy of novel compounds. To routinely apply such novel biomarkers with certainty, a well-defined data package… read more here.
Keywords: biomarker; drug; qualification; biomarker qualification ... See more keywords