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In this section: Biomarker Qualification Program

Reviews: Qualification of Biomarker: clusterin (CLU), Cystatin-C (CysC), Kidney Injury Molecule-1 (KIM-1), N-acetyl-beta-D-glucosaminidase (NAG), Neutrophil Gelatinase-Associated Lipocalin (NGAL), and osteopontin (OPN)

DDTBMQ000014 FNIH PSTC Executive summary final
Biomarker Qualification Program Office of Clinical Pharmacology Full Qualification Package Review
Clinical Review of PSTC/FNIH Kidney Safety Biomarker Qualification Submission
Foundation for the National Institutes of Health Predictive Safety Testing Consortium Nephrotoxicity Working Group Executive Summary
Statistical Review and Evaluation Biomarker Qualification
Qualification Determination CPath Clinical Nephrotox Limited
Review of CDRH Analytical validation consultation FNIH PSTC CM urinary biomarkers

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