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Cerebrospinal Fluid Biomarkers for Alzheimer's Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team.
Arnerić SP, Batrla-Utermann R, Beckett L, Bittner T, Blennow K, Carter L, Dean R, Engelborghs S, Genius J, Gordon MF, Hitchcock J, Kaplow J, Luthman J, Meibach R, Raunig D, Romero K, Samtani MN, Savage M, Shaw L, Stephenson D, Umek RM, Vanderstichele H, Willis B, Yule S. Arnerić SP, et al. Among authors: raunig d. J Alzheimers Dis. 2017;55(1):19-35. doi: 10.3233/JAD-160573. J Alzheimers Dis. 2017. PMID: 27662307 Free PMC article. Review.
Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease.
Hill DLG, Schwarz AJ, Isaac M, Pani L, Vamvakas S, Hemmings R, Carrillo MC, Yu P, Sun J, Beckett L, Boccardi M, Brewer J, Brumfield M, Cantillon M, Cole PE, Fox N, Frisoni GB, Jack C, Kelleher T, Luo F, Novak G, Maguire P, Meibach R, Patterson P, Bain L, Sampaio C, Raunig D, Soares H, Suhy J, Wang H, Wolz R, Stephenson D. Hill DLG, et al. Among authors: raunig d. Alzheimers Dement. 2014 Jul;10(4):421-429.e3. doi: 10.1016/j.jalz.2013.07.003. Alzheimers Dement. 2014. PMID: 24985687
Comparative analytical performance of multiple plasma Aβ42 and Aβ40 assays and their ability to predict positron emission tomography amyloid positivity.
Zicha S, Bateman RJ, Shaw LM, Zetterberg H, Bannon AW, Horton WA, Baratta M, Kolb HC, Dobler I, Mordashova Y, Saad ZS, Raunig DL, Spanakis EM, Li Y, Schindler SE, Ferber K, Rubel CE, Martone RL, Weber CJ, Edelmayer RM, Meyers EA, Bollinger JG, Rosenbaugh EG, Potter WZ; Alzheimer's Disease Neuroimaging Initiative (ADNI); Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium Plasma Aβ as a Predictor of Amyloid Positivity in Alzheimer's Disease Project Team. Zicha S, et al. Among authors: raunig dl. Alzheimers Dement. 2022 Jul 12:10.1002/alz.12697. doi: 10.1002/alz.12697. Online ahead of print. Alzheimers Dement. 2022. PMID: 35820077 Free PMC article.
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. 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.
A prototypical process for creating evidentiary standards for biomarkers and diagnostics.
Altar CA, Amakye D, Bounos D, Bloom J, Clack G, Dean R, Devanarayan V, Fu D, Furlong S, Hinman L, Girman C, Lathia C, Lesko L, Madani S, Mayne J, Meyer J, Raunig D, Sager P, Williams SA, Wong P, Zerba K. Altar CA, et al. Among authors: raunig d. Clin Pharmacol Ther. 2008 Feb;83(2):368-71. doi: 10.1038/sj.clpt.6100451. Epub 2007 Dec 19. Clin Pharmacol Ther. 2008. PMID: 18091762
Introduction to metrology series.
Sullivan DC, Bresolin L, Seto B, Obuchowski NA, Raunig DL, Kessler LG. Sullivan DC, et al. Stat Methods Med Res. 2015 Feb;24(1):3-8. doi: 10.1177/0962280214537332. Stat Methods Med Res. 2015. PMID: 25804285 No abstract available.
Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities.
Buckler AJ, Bresolin L, Dunnick NR, Sullivan DC, Aerts HJ, Bendriem B, Bendtsen C, Boellaard R, Boone JM, Cole PE, Conklin JJ, Dorfman GS, Douglas PS, Eidsaunet W, Elsinger C, Frank RA, Gatsonis C, Giger ML, Gupta SN, Gustafson D, Hoekstra OS, Jackson EF, Karam L, Kelloff GJ, Kinahan PE, McLennan G, Miller CG, Mozley PD, Muller KE, Patt R, Raunig D, Rosen M, Rupani H, Schwartz LH, Siegel BA, Sorensen AG, Wahl RL, Waterton JC, Wolf W, Zahlmann G, Zimmerman B. Buckler AJ, et al. Among authors: raunig d. Radiology. 2011 Jun;259(3):875-84. doi: 10.1148/radiol.10100800. Epub 2011 Feb 15. Radiology. 2011. PMID: 21325035 Free PMC article.
A Framework for Evaluating the Technical Performance of Multiparameter Quantitative Imaging Biomarkers (mp-QIBs).
Obuchowski NA, Huang E, deSouza NM, Raunig D, Delfino J, Buckler A, Hatt C, Wang X, Moskowitz C, Guimaraes A, Giger M, Hall TJ, Kinahan P, Pennello G. Obuchowski NA, et al. Among authors: raunig d. Acad Radiol. 2023 Feb;30(2):147-158. doi: 10.1016/j.acra.2022.08.031. Epub 2022 Sep 27. Acad Radiol. 2023. PMID: 36180328 Free PMC article. Review.
39 results