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Page 1
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. Among authors: ozer js. 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. Nat Biotechnol. 2010 May;28(5):486-94. doi: 10.1038/nbt.1627. Nat Biotechnol. 2010. PMID: 20458319
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
The current state of serum biomarkers of hepatotoxicity.
Ozer J, Ratner M, Shaw M, Bailey W, Schomaker S. Ozer J, et al. Toxicology. 2008 Mar 20;245(3):194-205. doi: 10.1016/j.tox.2007.11.021. Epub 2007 Dec 5. Toxicology. 2008. PMID: 18291570 Review.
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: ozer js. Nat Biotechnol. 2010 May;28(5):455-62. doi: 10.1038/nbt.1625. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458315
A systematic approach to preclinical and clinical safety biomarker qualification incorporating Bradford Hill's principles of causality association.
Chetty RK, Ozer JS, Lanevschi A, Schuppe-Koistinen I, McHale D, Pears JS, Vonderscher J, Sistare FD, Dieterle F. Chetty RK, et al. Among authors: ozer js. Clin Pharmacol Ther. 2010 Aug;88(2):260-2. doi: 10.1038/clpt.2010.77. Epub 2010 Jun 30. Clin Pharmacol Ther. 2010. PMID: 20592723 Review. No abstract available.
17 results