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The FDAs LOS encourages the exploratory use of these urinary biomarkers (-GST, CLU, CysC, KIM-1, NGAL, OPN, ALB, and TPRO) as biomarkers of renal tubule injury in early clinical trials. Additionally, the FDA stated that the exploratory human data suggests that the candidate drug-induced renal tubular injury biomarkers may be more sensitive and specific for the detection of acute kidney injury, especially when used in combination, than traditional means of monitoring for nephrotoxicity

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