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Page 1
Impact of biomarker development on drug safety assessment.
Marrer E, Dieterle F. Marrer E, et al. Among authors: dieterle f. Toxicol Appl Pharmacol. 2010 Mar 1;243(2):167-79. doi: 10.1016/j.taap.2009.12.015. Epub 2009 Dec 28. Toxicol Appl Pharmacol. 2010. PMID: 20036272 Review.
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: dieterle f. Nat Biotechnol. 2010 May;28(5):478-85. doi: 10.1038/nbt.1623. Nat Biotechnol. 2010. PMID: 20458318 Free PMC article.
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
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. Among authors: dieterle f. 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
36 results