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The inability to unequivocally predict translatable drug-induced kidney injury in nonclinical studies during pharmacological development is evidenced by drug attrition in human clinical trials. Eight urinary proteins have been qualified as renal safety biomarkers for limited context of use in nonclinical drug development studies in rats. Formal qualification of human renal safety biomarkers is pending the submission of data from prospective clinical trials and analyses of biomarker performance to the Food and Drug Administration and European Medicines Agency by the Foundation for the National Institutes of Health and Predictive Safety Testing Consortium’s Nephrotoxicity Working Group. In vitro kidney platforms may be leveraged to investigate the potential risk of compound-induced acute kidney injury and/or dysfunction. The early assessment of drug-related kidney safety profiles using biomarker-level changes in animal models and in vitro platforms could significantly reduce renal safety-related drug attrition; yet, there are no well-validated in vitro systems to enable comprehensive investigations of compound-induced nephrotoxicity. Thus, histopathology remains the gold standard for diagnosing nephron-specific damage. Traditional and emerging biomarker panels should be combined with histopathology and/or cytopathology to enable early identification of compound-induced kidney injury.

Brief Overview: Assessment of Compound-induced Acute Kidney Injury Using Animal Models, Biomarkers, and In Vitro Platforms