Quantitative Imaging Test Approval and Biomarker Qualification: Interrelated but Distinct Activities

Autor: Lawrence H. Schwartz, Lisa Karam, Claus Bendtsen, Bernard Bendriem, Ronald Boellaard, Maryellen L. Giger, Gary S. Dorfman, Edward F. Jackson, Willy Eidsaunet, Brian Zimmerman, Mark A. Rosen, David E. Gustafson, Barry A. Siegel, Patricia E. Cole, Walter Wolf, Cathy Elsinger, Pamela S. Douglas, Haren Rupani, N. Reed Dunnick, Gary J. Kelloff, Geoffrey McLennan, Colin G Miller, Gudrun Zahlmann, Rick Patt, Sandeep N. Gupta, Richard L. Wahl, Keith E. Muller, Otto S. Hoekstra, James J Conklin, Andrew J. Buckler, David Raunig, John C. Waterton, Richard Frank, Hugo J.W.L. Aerts, John M. Boone, A. Gregory Sorensen, Daniel C. Sullivan, P. David Mozley, Constantine Gatsonis, Paul E. Kinahan, Linda B. Bresolin

Publikováno v: Radiology, 259(3), 875-884. Radiological Society of North America Inc.
Radiology, 259(3), 875-884. Radiological Society of North America, Inc.
Buckler, A J, Bresolin, L, Dunnick, N R, Sullivan, D C, Aerts, H J W L, Bendriem, B, Bendtsen, C, Boellaard, R, Boone, J M, Cole, P E, Conklin, J J, Dorfman, G S, Douglas, P S, Eidsaunet, W, Elsinger, C, Frank, R A, Gatsonis, C, Giger, M L, Gupta, S N, Gustafson, D, Hoekstra, O S, Jackson, E F, Karam, L, Kelloff, G J, Kinahan, P E, McLennan, G, Miller, C G, Mozley, P D, Muller, K E, Patt, R, Raunig, D, Rupani, H, Schwartz, L H, Siegel, B A, Sorensen, A G, Wahl, R L, Waterton, J C, Wolff, W, Zahlmann, G & Zimmerman, B 2011, ' Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities ', Radiology, vol. 259, no. 3, pp. 875-884 . https://doi.org/10.1148/radiol.10100800

Quantitative imaging biomarkers could speed the development of new treatments for unmet medical needs and improve routine clinical care. However, it is not clear how the various regulatory and nonregulatory (eg, reimbursement) processes (often referr

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d6bc03ea15c42cf93a1e87177e49efcd
https://doi.org/10.1148/radiol.10100800