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Proper Citation: ILSI HESI Drug-induced Nephrotoxicity Biomarkers (RRID:SCR_003716)
Description: Urinary kidney biomarkers, Clusterin and Renal Papillary Antigen-1 (RPA-1), that sponsors may use to determine more conservative NOAELs for estimating starting doses in the initial human clinical trial of a drug that displays nonclinical nephrotoxicity as determined by histopathology. When tested with a limited number of nephrotoxic compounds, the Receiver Operating Characteristic (ROC) analyses showed that urinary clusterin and renal papillary antigen-1 (RPA-1) have better sensitivity and specificity than BUN and creatinine for the detection of specific kidney pathologies in male rats. Clusterin and RPA-1 provide additional and complementary information to BUN, serum creatinine (sCr), and histopathology for the detection of acute drug-induced nephrotoxicity in safety assessment studies.
Abbreviations: HESI Nephrotoxicity Biomarkers
Synonyms: HESI Drug-induced Nephrotoxicity Biomarkers, ILSI / HESI Nephrotoxicity Working Group Drug-induced Nephrotoxicity Biomarkers, International Life Sciences Institute / Health and Environmental Sciences Institute Nephrotoxicity Working Group Drug-induced Nephrotoxicity Biomarkers
Resource Type: narrative resource, data or information resource, standard specification
Keywords: biomarker, drug development, drug, urinary, urinary biomarker, gold standard, clusterin, renal papillary antigen, kidney, gold standard
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