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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: sistare fd. Nat Biotechnol. 2010 May;28(5):478-85. doi: 10.1038/nbt.1623. Nat Biotechnol. 2010. PMID: 20458318 Free PMC article.
A rapid urine test for early detection of kidney injury.
Vaidya VS, Ford GM, Waikar SS, Wang Y, Clement MB, Ramirez V, Glaab WE, Troth SP, Sistare FD, Prozialeck WC, Edwards JR, Bobadilla NA, Mefferd SC, Bonventre JV. Vaidya VS, et al. Among authors: sistare fd. Kidney Int. 2009 Jul;76(1):108-14. doi: 10.1038/ki.2009.96. Epub 2009 Apr 22. Kidney Int. 2009. PMID: 19387469 Free PMC article.
Novel biomarkers of acute kidney toxicity.
Goodsaid FM, Blank M, Dieterle F, Harlow P, Hausner E, Sistare F, Thompson A, Vonderscher J. Goodsaid FM, et al. Clin Pharmacol Ther. 2009 Nov;86(5):490-6. doi: 10.1038/clpt.2009.149. Epub 2009 Aug 26. Clin Pharmacol Ther. 2009. PMID: 19710639
Plasma MicroRNAs as sensitive and specific biomarkers of tissue injury.
Laterza OF, Lim L, Garrett-Engele PW, Vlasakova K, Muniappa N, Tanaka WK, Johnson JM, Sina JF, Fare TL, Sistare FD, Glaab WE. Laterza OF, et al. Among authors: sistare fd. Clin Chem. 2009 Nov;55(11):1977-83. doi: 10.1373/clinchem.2009.131797. Epub 2009 Sep 10. Clin Chem. 2009. PMID: 19745058
Research at the interface of industry, academia and regulatory science.
Mattes WB, Walker EG, Abadie E, Sistare FD, Vonderscher J, Woodcock J, Woosley RL. Mattes WB, et al. Among authors: sistare fd. Nat Biotechnol. 2010 May;28(5):432-3. doi: 10.1038/nbt0510-432. Nat Biotechnol. 2010. PMID: 20458309 No abstract available.
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
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. Nat Biotechnol. 2010 May;28(5):455-62. doi: 10.1038/nbt.1625. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458315
113 results