Biomarkers can be utilized as primary surrogate endpoint as a basis for accelerated approval (US), and as secondary or exploratory endpoints for drug mechanism of action or aspects of Safety monitoring.
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Use of Biomarkers in Orphan Drug Development
Published by IRDiRC
Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentEndpoint BiomarkerOrphan DrugBiomarker DevelopmentEndpoint