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Towards consensus practices to qualify safety biomarkers for use in early drug development.
Sistare FD, Dieterle F, Troth S, Holder DJ, Gerhold D, Andrews-Cleavenger D, Baer W, Betton G, Bounous D, Carl K, Collins N, Goering P, Goodsaid F, Gu YZ, Guilpin V, Harpur E, Hassan A, Jacobson-Kram D, Kasper P, Laurie D, Lima BS, Maciulaitis R, Mattes W, Maurer G, Obert LA, Ozer J, Papaluca-Amati M, Phillips JA, Pinches M, Schipper MJ, Thompson KL, Vamvakas S, Vidal JM, Vonderscher J, Walker E, Webb C, Yu Y. Sistare FD, et al. Nat Biotechnol. 2010 May;28(5):446-54. doi: 10.1038/nbt.1634. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458314
Kidney injury molecule-1 outperforms traditional biomarkers of kidney injury in preclinical biomarker qualification studies.
Vaidya VS, Ozer JS, Dieterle F, Collings FB, Ramirez V, Troth S, Muniappa N, Thudium D, Gerhold D, Holder DJ, Bobadilla NA, Marrer E, Perentes E, Cordier A, Vonderscher J, Maurer G, Goering PL, Sistare FD, Bonventre JV. Vaidya VS, et al. Nat Biotechnol. 2010 May;28(5):478-85. doi: 10.1038/nbt.1623. Nat Biotechnol. 2010. PMID: 20458318 Free PMC article.
A panel of urinary biomarkers to monitor reversibility of renal injury and a serum marker with improved potential to assess renal function.
Ozer JS, Dieterle F, Troth S, Perentes E, Cordier A, Verdes P, Staedtler F, Mahl A, Grenet O, Roth DR, Wahl D, Legay F, Holder D, Erdos Z, Vlasakova K, Jin H, Yu Y, Muniappa N, Forest T, Clouse HK, Reynolds S, Bailey WJ, Thudium DT, Topper MJ, Skopek TR, Sina JF, Glaab WE, Vonderscher J, Maurer G, Chibout SD, Sistare FD, Gerhold DL. Ozer JS, et al. Among authors: gerhold dl. Nat Biotechnol. 2010 May;28(5):486-94. doi: 10.1038/nbt.1627. Nat Biotechnol. 2010. PMID: 20458319
Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium.
Dieterle F, Sistare F, Goodsaid F, Papaluca M, Ozer JS, Webb CP, Baer W, Senagore A, Schipper MJ, Vonderscher J, Sultana S, Gerhold DL, Phillips JA, Maurer G, Carl K, Laurie D, Harpur E, Sonee M, Ennulat D, Holder D, Andrews-Cleavenger D, Gu YZ, Thompson KL, Goering PL, Vidal JM, Abadie E, Maciulaitis R, Jacobson-Kram D, Defelice AF, Hausner EA, Blank M, Thompson A, Harlow P, Throckmorton D, Xiao S, Xu N, Taylor W, Vamvakas S, Flamion B, Lima BS, Kasper P, Pasanen M, Prasad K, Troth S, Bounous D, Robinson-Gravatt D, Betton G, Davis MA, Akunda J, McDuffie JE, Suter L, Obert L, Guffroy M, Pinches M, Jayadev S, Blomme EA, Beushausen SA, Barlow VG, Collins N, Waring J, Honor D, Snook S, Lee J, Rossi P, Walker E, Mattes W. Dieterle F, et al. Among authors: gerhold dl. Nat Biotechnol. 2010 May;28(5):455-62. doi: 10.1038/nbt.1625. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458315
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