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TITLE: Patient-reported, observer-reported and performance outcomes in qualification procedures at the European Medicines Agency 2013-2018 Full Text
AUTHORS: Silva, Marcio; Moseley, Jane; Vetter, Thorsten; Regnstrom, Jan; Tome, Maria; Aarum, Stiina; Cerreta, Francesca; Schabel, Elmer; Vamvakas, Spiros;
PUBLISHED: 2023, SOURCE: BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

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TITLE: Renal biomarker qualification submission: A dialog between the FDA-EMEA and Predictive Safety Testing Consortium Full Text
AUTHORS: Dieterle, F; Sistare, F; Goodsaid, F; Papaluca, M; Ozer, JS; Webb, CP; Baer, W; Senagore, A; Schipper, MJ; Vonderscher, J; Sultana, S; Gerhold, DL; Phillips, JA; Maurer, G; Carl, K; Laurie, D; Harpur, E; Sonee, M; Ennulat, D; Holder, D; Andrews Cleavenger, D; Gu, YZ; Thompson, KL; Goering, PL; Vidal, JM; Abadie, E; MacIulaitis, R; Jacobson Kram, D; Defelice, AF; Hausner, EA; Blank, M; Thompson, A; Harlow, P; Throckmorton, D; Xiao, S; Xu, N; Taylor, W; Vamvakas, S; Flamion, B; Lima, BS ; Kasper, P; Pasanen, M; Prasad, K; Troth, S; Bounous, D; Robinson Gravatt, D; Betton, G; Davis, MA; Akunda, J; McDuffie, JE; Suter, L; Obert, L; Guffroy, M; Pinches, M; Jayadev, S; Blomme, EA; Beushausen, SA; Barlow, VG; Collins, N; Waring, J; Honor, D; Snook, S; Lee, J; Rossi, P; Walker, E; Mattes, W; ...More
PUBLISHED: 2010, SOURCE: Nature Biotechnology, VOLUME: 28, ISSUE: 5

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