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Page 1
Pharmacogenomics and regulatory decision making: an international perspective.
Mendrick DL, Brazell C, Mansfield EA, Pietrusko R, Barilero I, Hackett J, Stürzebecher S, Jacobson-Kram D. Mendrick DL, et al. Among authors: mansfield ea. Pharmacogenomics J. 2006 May-Jun;6(3):154-7. doi: 10.1038/sj.tpj.6500364. Pharmacogenomics J. 2006. PMID: 16415918 No abstract available.
Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop.
Lesko LJ, Salerno RA, Spear BB, Anderson DC, Anderson T, Brazell C, Collins J, Dorner A, Essayan D, Gomez-Mancilla B, Hackett J, Huang SM, Ide S, Killinger J, Leighton J, Mansfield E, Meyer R, Ryan SG, Schmith V, Shaw P, Sistare F, Watson M, Worobec A. Lesko LJ, et al. J Clin Pharmacol. 2003 Apr;43(4):342-58. doi: 10.1177/0091270003252244. J Clin Pharmacol. 2003. PMID: 12723455
Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics.
Rodriguez H, Tezak Z, Mesri M, Carr SA, Liebler DC, Fisher SJ, Tempst P, Hiltke T, Kessler LG, Kinsinger CR, Philip R, Ransohoff DF, Skates SJ, Regnier FE, Anderson NL, Mansfield E; Workshop Participants. Rodriguez H, et al. Clin Chem. 2010 Feb;56(2):237-43. doi: 10.1373/clinchem.2009.136416. Epub 2009 Dec 10. Clin Chem. 2010. PMID: 20007859 Review.
Companion diagnostics.
Becker R Jr, Mansfield E. Becker R Jr, et al. Clin Adv Hematol Oncol. 2010 Jul;8(7):478-9. Clin Adv Hematol Oncol. 2010. PMID: 20864915 No abstract available.
Continuing to strengthen FDA's science approach to emerging technologies.
Anatol R, Bauer S, Epstein S, Filice R, Lauritsen K, Lee MH, Mansfield E, McMurry-Heath M, Milone J, Peña C, Pollack S, Zineh I. Anatol R, et al. Nanomedicine. 2013 Jul;9(5):594-9. doi: 10.1016/j.nano.2013.04.005. Epub 2013 May 18. Nanomedicine. 2013. PMID: 23692697
Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration.
Regnier FE, Skates SJ, Mesri M, Rodriguez H, Tezak Z, Kondratovich MV, Alterman MA, Levin JD, Roscoe D, Reilly E, Callaghan J, Kelm K, Brown D, Philip R, Carr SA, Liebler DC, Fisher SJ, Tempst P, Hiltke T, Kessler LG, Kinsinger CR, Ransohoff DF, Mansfield E, Anderson NL. Regnier FE, et al. Clin Chem. 2010 Feb;56(2):165-71. doi: 10.1373/clinchem.2009.140087. Epub 2009 Dec 10. Clin Chem. 2010. PMID: 20007858
23 results