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U.S. Department of Health and Human Services


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Drug Development Tool (DDT): Biomarker Qualification Program

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


 General  AreaSubmitter Biomarker(s) Referenced in GuidanceIssuance Date with Link to Specific Guidance Supporting Information
 NonclinicalPredictive Safety and Testing Consortium (PSTC), Nephrotoxicity Working Group (NWG)Urinary biomarkers: Albumin, β2 Microglobulin, Clusterin, Cystatin C, KIM-1, Total Protein, and Trefoil factor-3 4/14/2008 Drug-induced Nephrotoxicity Biomarkers Reviews
 Nonclinical International Life Sciences Institute (ILSI)/ Health and Environmental Sciences Institute (HESI), Nephrotoxicity Working Group Urinary biomarkers: Alpha-glutathione S-transferase (αGST), Clusterin, Renal Papillary Antigen (RPA-1)9/22/2010 Drug-induced Nephrotoxicity Biomarkers Reviews
 Nonclinical PJ O'Brien, WJ Reagan, MJ York and MC Jacobsen Serum/plasma biomarkers: Cardiac troponins T (cTnT) and I (cTnI) 2/23/2012 Drug-induced Cardiotoxicity Biomarkers Reviews
 ClinicalMycoses Study Group Serum/bronchoalveolar lavage fluid biomarker: Galactomannan 10/24/2014 Invasive Aspergillosis Biomarker 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.”