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Novel Biomarkers of Kidney Tissue Stress Response

4 NOVEL BIOMARKERS OF KIDNEY TISSUE STRESS RESPONSE [Pg.436]

Cnrrent regnlatory opinion supports inclusion of these biomarkers in nonclinical safety studies supporting clinical trials, for pnrposes of monitoring DIKI in animal (e.g., rat) stndies, and encourages exploratory inclusion in nonclinical stndies (rodent and nonrodent species) and in clinical trials of pharmacenticals where DIKI has been identified as a potential canse for concern (Dieterle et al., 2010a). [Pg.436]



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