Concepedia

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

Frank Dieterle, Frank D. Sistare, Federico Goodsaid, Marisa Papaluca, Josef Ozer, Craig P. Webb, William Baer, Anthony J. Senagore, Matthew J. Schipper, Jacky Vonderscher,

Nature Biotechnology · 2010 · 406 citations · 9 references

DOI

Concepts

References

9

Comparing the Areas under Two or More Correlated Receiver Operating Characteristic Curves: A Nonparametric Approach

Elizabeth R. DeLong, David M. DeLong, Daniel L. Clarke‐Pearson · Biometrics · 1988 · 22.3K citations

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Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement

Jean W. Lee, Viswanath Devanarayan, Yu Chen Barrett et al. · Pharmaceutical Research · 2006 · 759 citations

, , +11

Next-generation biomarkers for detecting kidney toxicity

Joseph V. Bonventre, Vishal S. Vaidya, Robert Schmouder et al. · Nature Biotechnology · 2010 · 543 citations · Full text

, , +14

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

Frank Dieterle, Elias Perentes, André Cordier et al. · Nature Biotechnology · 2010 · 331 citations

, , +14

Urine Biomarkers Predict the Cause of Glomerular Disease

Sanju A. Varghese, T. Brian Powell, Milos N. Budisavljevic et al. · Journal of the American Society of Nephrology · 2007 · 221 citations · Full text

, , +17