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Biospecimen reporting for improved study quality (BRISQ).
Moore HM, Kelly AB, Jewell SD, McShane LM, Clark DP, Greenspan R, Hayes DF, Hainaut P, Kim P, Mansfield EA, Potapova O, Riegman P, Rubinstein Y, Seijo E, Somiari S, Watson P, Weier HU, Zhu C, Vaught J. Moore HM, et al. Among authors: mansfield ea. Cancer Cytopathol. 2011 Apr 25;119(2):92-101. doi: 10.1002/cncy.20147. Epub 2011 Mar 22. Cancer Cytopathol. 2011. PMID: 21433001 Free article.
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.
The FDA and genetic testing.
Litwack ED, Mansfield E, Shuren J. Litwack ED, et al. N Engl J Med. 2015 Jun 4;372(23):2273-4. doi: 10.1056/NEJMc1504604. Epub 2015 May 27. N Engl J Med. 2015. PMID: 26014594 Free article. No abstract available.
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.