The qualification of nephrotoxicity biomarkers in preclinical and clinical laboratories in academic, government or industrial organizations requires intensive cooperation and communication between sponsors for biomarker qualification and regulatory scientists.On June 12, 2008, the United States Food and Drug Administration (FDA) and European Medicines Agency (EMEA) acknowledged their acceptance of seven urinary biomarkers for rat nephrotoxieity: kidney injury molecule-1 (KIM-1), albumin, total urinary protein, β2 microglobulin, Cystatin C, clusterin, and trefoil factor-3.Acceptance of these biomarkers was based onthe fact that limited sensitivity and specificity of accessible biomarkers of nephrotoxicity in current use (particularly serum creatinine and serum blood urea nitrogen (BUN)) prevents early detection of compound induced acute kidney injury (AKI).Serum creatinine and serum BUN have limited applicability because they are not region-specific and they increase significantly only after substantial kidney injury occurs after~≧2/3 of the nephron function is lost.The preclinical setting is an area where the urgency for the development and qualification of better nephrotoxicity biomarkers is clear and an accurate definition of application contexts needed for qualification is possible.Cisplatin is a chemotherapeutic agent used to treat solid tumors, including ovarian, head and neck, and testicular germ cell tumors; it adversely causes dose limiting nephrotoxicity.