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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: schneider ck. Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052. Nat Rev Drug Discov. 2010. PMID: 20190786 Review.
[Clinical trials with advanced therapy medicinal products].
Schüssler-Lenz M, Schneider CK. Schüssler-Lenz M, et al. Among authors: schneider ck. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010 Jan;53(1):68-74. doi: 10.1007/s00103-009-0984-4. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010. PMID: 20011994 German.
Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.
Salmikangas P, Menezes-Ferreira M, Reischl I, Tsiftsoglou A, Kyselovic J, Borg JJ, Ruiz S, Flory E, Trouvin JH, Celis P, Ancans J, Timon M, Pante G, Sladowski D, Lipnik-Stangelj M, Schneider CK. Salmikangas P, et al. Among authors: schneider ck. Regen Med. 2015;10(1):65-78. doi: 10.2217/rme.14.65. Regen Med. 2015. PMID: 25562353 Review.
Regulatory evaluation of Glybera in Europe - two committees, one mission.
Melchiorri D, Pani L, Gasparini P, Cossu G, Ancans J, Borg JJ, Drai C, Fiedor P, Flory E, Hudson I, Leufkens HG, Müller-Berghaus J, Narayanan G, Neugebauer B, Pokrotnieks J, Robert JL, Salmonson T, Schneider CK. Melchiorri D, et al. Among authors: schneider ck. Nat Rev Drug Discov. 2013 Sep;12(9):719. doi: 10.1038/nrd3835-c1. Epub 2013 Aug 19. Nat Rev Drug Discov. 2013. PMID: 23954897 No abstract available.
57 results