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.
View this resource Bookmark this resource
Use of Biomarkers in Orphan Drug Development
Published by IRDiRC
Regulatory AffairsResearch and Drug DevelopmentClinical DevelopmentEndpoint BiomarkerOrphan DrugBiomarker DevelopmentEndpoint