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Resource Name
PSTC Nephrotoxicity Biomarkers
RRID:SCR_003709 RRID Copied      
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PSTC Nephrotoxicity Biomarkers (RRID:SCR_003709)
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Resource Information

URL: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM382536.pdf

Proper Citation: PSTC Nephrotoxicity Biomarkers (RRID:SCR_003709)

Description: Urinary kidney biomarkers (KIM-1, albumin, total protein, 2-microglobulin, cystatin C, clusterin and trefoil factor-3) that are considered acceptable biomarkers for the detection of acute drug-induced nephrotoxicity in rats and can be included along with traditional clinical chemistry markers and histopathology in toxicology studies. These biomarkers may be used voluntarily as additional evidence of nephrotoxicity in nonclinical safety assessment studies to complement the standard data (BUN and sCr). In ROC analyses, some of these biomarkers showed better sensitivity and specificity than BUN and sCr relative to histopathological alterations considered to be the gold standard when tested with a limited number of nephrotoxicant and control compounds.

Abbreviations: PSTC Nephrotoxicity Biomarkers

Synonyms: Predictive Safety and Testing Consortium Drug-induced Nephrotoxicity Biomarkers, PSTC NWG Drug-induced Nephrotoxicity Biomarkers

Resource Type: standard specification, narrative resource, data or information resource

Keywords: biomarker, drug development, drug, urinary, urinary biomarker, gold standard, kim-1, albumin, total protein, beta2-microglobulin, cystatin c, clusterin, trefoil factor-3, kidney, nonclinical

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