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Page 1
Challenges with advanced therapy medicinal products and how to meet them.
Committee for Advanced Therapies (CAT); CAT Scientific Secretariat; Schneider CK, Salmikangas P, Jilma B, Flamion B, Todorova LR, Paphitou A, Haunerova I, Maimets T, Trouvin JH, Flory E, Tsiftsoglou A, Sarkadi B, Gudmundsson K, O'Donovan M, Migliaccio G, Ancāns J, Maciulaitis R, Robert JL, Samuel A, Ovelgönne JH, Hystad M, Fal AM, Lima BS, Moraru AS, Turcáni P, Zorec R, Ruiz S, Akerblom L, Narayanan G, Kent A, Bignami F, Dickson JG, Niederwieser D, Figuerola-Santos MA, Reischl IG, Beuneu C, Georgiev R, Vassiliou M, Pychova A, Clausen M, Methuen T, Lucas S, Schüssler-Lenz M, Kokkas V, Buzás Z, MacAleenan N, Galli MC, Linē A, Gulbinovic J, Berchem G, Fraczek M, Menezes-Ferreira M, Vilceanu N, Hrubisko M, Marinko P, Timón M, Cheng W, Crosbie GA, Meade N, di Paola ML, VandenDriessche T, Ljungman P, D'Apote L, Oliver-Diaz O, Büttel I, Celis P. Committee for Advanced Therapies (CAT), et al. Among authors: flamion b. Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052. Nat Rev Drug Discov. 2010. PMID: 20190786 Review.
Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium.
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. Dieterle F, et al. Among authors: flamion b. Nat Biotechnol. 2010 May;28(5):455-62. doi: 10.1038/nbt.1625. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458315
Appropriate evidence for adaptive marketing authorization.
de Jong JP, Grobbee DE, Flamion B, Forda SR, Leufkens HG. de Jong JP, et al. Among authors: flamion b. Nat Rev Drug Discov. 2013 Sep;12(9):647-8. doi: 10.1038/nrd4114. Nat Rev Drug Discov. 2013. PMID: 23989775 No abstract available.
Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.
Banerjee AK, Okun S, Edwards IR, Wicks P, Smith MY, Mayall SJ, Flamion B, Cleeland C, Basch E; Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium. Banerjee AK, et al. Among authors: flamion b. Drug Saf. 2013 Dec;36(12):1129-49. doi: 10.1007/s40264-013-0113-z. Drug Saf. 2013. PMID: 24092596 Free PMC article.
Report on the joint EFPIA, DIA and EMEA pharmacogenetics workshop: moving toward clinical application.
McCarthy A, Kerr M, Abadie E, Chibout SD, Imbert G, Cohen N, Drakoulis N, Knudsen LE, Flamion B, Hashimoto L, Kreutz WV, McHale D, Mitchell T, Papaluca Amati M, Roberts R, Shaw P, Stuerzebecher CS, Townend D. McCarthy A, et al. Among authors: flamion b. Pharmacogenomics. 2004 Sep;5(6):731-9. doi: 10.1517/14622416.5.6.731. Pharmacogenomics. 2004. PMID: 15335293 No abstract available.
76 results