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Page 1
Expression profiling of human immune cell subsets identifies miRNA-mRNA regulatory relationships correlated with cell type specific expression.
Allantaz F, Cheng DT, Bergauer T, Ravindran P, Rossier MF, Ebeling M, Badi L, Reis B, Bitter H, D'Asaro M, Chiappe A, Sridhar S, Pacheco GD, Burczynski ME, Hochstrasser D, Vonderscher J, Matthes T. Allantaz F, et al. Among authors: vonderscher j. PLoS One. 2012;7(1):e29979. doi: 10.1371/journal.pone.0029979. Epub 2012 Jan 20. PLoS One. 2012. PMID: 22276136 Free PMC article.
Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
Goodsaid FM, Amur S, Aubrecht J, Burczynski ME, Carl K, Catalano J, Charlab R, Close S, Cornu-Artis C, Essioux L, Fornace AJ Jr, Hinman L, Hong H, Hunt I, Jacobson-Kram D, Jawaid A, Laurie D, Lesko L, Li HH, Lindpaintner K, Mayne J, Morrow P, Papaluca-Amati M, Robison TW, Roth J, Schuppe-Koistinen I, Shi L, Spleiss O, Tong W, Truter SL, Vonderscher J, Westelinck A, Zhang L, Zineh I. Goodsaid FM, et al. Among authors: vonderscher j. Nat Rev Drug Discov. 2010 Jun;9(6):435-45. doi: 10.1038/nrd3116. Nat Rev Drug Discov. 2010. PMID: 20514070 Review.
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: vonderscher j. 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
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: vonderscher j. Nat Biotechnol. 2010 May;28(5):455-62. doi: 10.1038/nbt.1625. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458315
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: vonderscher j. Nat Biotechnol. 2010 May;28(5):446-54. doi: 10.1038/nbt.1634. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458314
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: vonderscher j. 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.
44 results