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Page 1
Quantitative imaging biomarkers: a review of statistical methods for technical performance assessment.
Raunig DL, McShane LM, Pennello G, Gatsonis C, Carson PL, Voyvodic JT, Wahl RL, Kurland BF, Schwarz AJ, Gönen M, Zahlmann G, Kondratovich MV, O'Donnell K, Petrick N, Cole PE, Garra B, Sullivan DC; QIBA Technical Performance Working Group. Raunig DL, et al. Among authors: kondratovich mv. Stat Methods Med Res. 2015 Feb;24(1):27-67. doi: 10.1177/0962280214537344. Epub 2014 Jun 11. Stat Methods Med Res. 2015. PMID: 24919831 Free PMC article. Review.
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.
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: kondratovich mv. Clin Chem. 2010 Feb;56(2):165-71. doi: 10.1373/clinchem.2009.140087. Epub 2009 Dec 10. Clin Chem. 2010. PMID: 20007858
The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions.
Kessler LG, Barnhart HX, Buckler AJ, Choudhury KR, Kondratovich MV, Toledano A, Guimaraes AR, Filice R, Zhang Z, Sullivan DC; QIBA Terminology Working Group. Kessler LG, et al. Among authors: kondratovich mv. Stat Methods Med Res. 2015 Feb;24(1):9-26. doi: 10.1177/0962280214537333. Epub 2014 Jun 11. Stat Methods Med Res. 2015. PMID: 24919826
Patient safety and the next generation of HPV DNA tests.
Simon K, Kondratovich MV, Hojvat S, Gutierrez A. Simon K, et al. Among authors: kondratovich mv. Am J Clin Pathol. 2011 May;135(5):798-9; author reply 799-803. doi: 10.1309/AJCPMF4DSDIW3ILO. Am J Clin Pathol. 2011. PMID: 21502437 No abstract available.