A roadmap for biomarker qualification

Urinary biomarkers trefoil factor 3 and albumin enable early detection of kidney tubular injury

(2010) Yan Yu et al.   NATURE BIOTECHNOLOGY

Urinary clusterin, cystatin C, β2-microglobulin and total protein as markers to detect drug-induced kidney injury

(2010) Frank Dieterle et al.   NATURE BIOTECHNOLOGY

Next-generation biomarkers for detecting kidney toxicity

(2010) Joseph V Bonventre et al.   NATURE BIOTECHNOLOGY

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

(2010) Frank Dieterle et al.   NATURE BIOTECHNOLOGY

Towards consensus practices to qualify safety biomarkers for use in early drug development

(2010) Frank D Sistare et al.   NATURE BIOTECHNOLOGY

A panel of urinary biomarkers to monitor reversibility of renal injury and a serum marker with improved potential to assess renal function

(2010) Josef S Ozer et al.   NATURE BIOTECHNOLOGY

Kidney injury molecule-1 outperforms traditional biomarkers of kidney injury in preclinical biomarker qualification studies

(2010) Vishal S Vaidya et al.   NATURE BIOTECHNOLOGY