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U.S. Department of Health and Human Services

Drugs

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Drug Development Tool (DDT): Biomarker Qualification Program

Biomarker Recommendations - December 2012 (updated 12/1/2012) 

 

 General AreaGuidance Type Biomarker(s) Referenced in GuidanceIssuance Date with Link to Specific GuidanceLink to Supporting Information
 
 NonclinicalFinalUrinary biomarkers: Albumin, β2 Microglobulin, Clusterin, Cystatin C, KIM-1, Total Protein, and Trefoil factor-3  4/14/2008 Reviews
     
     
     
     
     
     
     

 Note: All referenced biomarkers in this table are qualified for a specific context of use. For information about how the referenced biomarkers should be used, refer to table columns “Issuance Date with Link to Specific Guidance” and “Link to Supporting Information.”