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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. Among authors: tezak z. Clin Chem. 2010 Feb;56(2):237-43. doi: 10.1373/clinchem.2009.136416. Epub 2009 Dec 10. Clin Chem. 2010. PMID: 20007859 Review.
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. Among authors: tezak z. Clin Chem. 2010 Feb;56(2):165-71. doi: 10.1373/clinchem.2009.140087. Epub 2009 Dec 10. Clin Chem. 2010. PMID: 20007858
The journey to regulation of protein-based multiplex quantitative assays.
Boja ES, Jortani SA, Ritchie J, Hoofnagle AN, Težak Ž, Mansfield E, Keller P, Rivers RC, Rahbar A, Anderson NL, Srinivas P, Rodriguez H. Boja ES, et al. Among authors: tezak z. Clin Chem. 2011 Apr;57(4):560-7. doi: 10.1373/clinchem.2010.156034. Epub 2011 Feb 7. Clin Chem. 2011. PMID: 21300740
Statistical design for biospecimen cohort size in proteomics-based biomarker discovery and verification studies.
Skates SJ, Gillette MA, LaBaer J, Carr SA, Anderson L, Liebler DC, Ransohoff D, Rifai N, Kondratovich M, Težak Ž, Mansfield E, Oberg AL, Wright I, Barnes G, Gail M, Mesri M, Kinsinger CR, Rodriguez H, Boja ES. Skates SJ, et al. Among authors: tezak z. J Proteome Res. 2013 Dec 6;12(12):5383-94. doi: 10.1021/pr400132j. Epub 2013 Oct 28. J Proteome Res. 2013. PMID: 24063748 Free PMC article.
Direct-to-consumer genetic testing: reliable or risky?
Spencer DH, Lockwood C, Topol E, Evans JP, Green RC, Mansfield E, Tezak Z. Spencer DH, et al. Among authors: tezak z. Clin Chem. 2011 Dec;57(12):1641-4. doi: 10.1373/clinchem.2011.167197. Epub 2011 Sep 1. Clin Chem. 2011. PMID: 21885623 No abstract available.
32 results