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The advanced therapy classification procedure. Overview of experience gained so far.
Voltz-Girolt C, Celis P, Boucaumont M, D'Apote L, Pinheiro MH, Papaluca-Amati M. Voltz-Girolt C, et al. Among authors: d apote l. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 Jul;54(7):811-5. doi: 10.1007/s00103-011-1309-y. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011. PMID: 21698533 Review.
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: d apote l. Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052. Nat Rev Drug Discov. 2010. PMID: 20190786 Review.