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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 - October 2014 (updated 10/24/2014)

 General  Area Submitter  Biomarker(s) Referenced in Guidance Issuance Date with Link to Specific Guidance  Supporting Information
 Nonclinical Predictive 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
 Clinical Mycoses 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.”