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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.
Metrology Standards for Quantitative Imaging Biomarkers.
Sullivan DC, Obuchowski NA, Kessler LG, Raunig DL, Gatsonis C, Huang EP, Kondratovich M, McShane LM, Reeves AP, Barboriak DP, Guimaraes AR, Wahl RL; RSNA-QIBA Metrology Working Group. Sullivan DC, et al. Radiology. 2015 Dec;277(3):813-25. doi: 10.1148/radiol.2015142202. Epub 2015 Aug 12. Radiology. 2015. PMID: 26267831 Free PMC article.
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
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. 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.
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
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