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Page 1
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. Among authors: kasper p. 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. Among authors: kasper p. Nat Biotechnol. 2010 May;28(5):455-62. doi: 10.1038/nbt.1625. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458315
Interlaboratory evaluation of genomic signatures for predicting carcinogenicity in the rat.
Fielden MR, Nie A, McMillian M, Elangbam CS, Trela BA, Yang Y, Dunn RT 2nd, Dragan Y, Fransson-Stehen R, Bogdanffy M, Adams SP, Foster WR, Chen SJ, Rossi P, Kasper P, Jacobson-Kram D, Tatsuoka KS, Wier PJ, Gollub J, Halbert DN, Roter A, Young JK, Sina JF, Marlowe J, Martus HJ, Aubrecht J, Olaharski AJ, Roome N, Nioi P, Pardo I, Snyder R, Perry R, Lord P, Mattes W, Car BD; Predictive Safety Testing Consortium; Carcinogenicity Working Group. Fielden MR, et al. Among authors: kasper p. Toxicol Sci. 2008 May;103(1):28-34. doi: 10.1093/toxsci/kfn022. Epub 2008 Feb 14. Toxicol Sci. 2008. PMID: 18281259
The utility of genetically modified mouse assays for identifying human carcinogens: a basic understanding and path forward. The Alternatives to Carcinogenicity Testing Committee ILSI HESI.
MacDonald J, French JE, Gerson RJ, Goodman J, Inoue T, Jacobs A, Kasper P, Keller D, Lavin A, Long G, McCullough B, Sistare FD, Storer R, van der Laan JW. MacDonald J, et al. Among authors: kasper p. Toxicol Sci. 2004 Feb;77(2):188-94. doi: 10.1093/toxsci/kfh037. Epub 2003 Dec 2. Toxicol Sci. 2004. PMID: 14657512 Review.
Critical issues with the in vivo comet assay: A report of the comet assay working group in the 6th International Workshop on Genotoxicity Testing (IWGT).
Speit G, Kojima H, Burlinson B, Collins AR, Kasper P, Plappert-Helbig U, Uno Y, Vasquez M, Beevers C, De Boeck M, Escobar PA, Kitamoto S, Pant K, Pfuhler S, Tanaka J, Levy DD. Speit G, et al. Among authors: kasper p. Mutat Res Genet Toxicol Environ Mutagen. 2015 May 1;783:6-12. doi: 10.1016/j.mrgentox.2014.09.006. Epub 2014 Sep 22. Mutat Res Genet Toxicol Environ Mutagen. 2015. PMID: 25953395
324 results