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