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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: ruiz s. Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052. Nat Rev Drug Discov. 2010. PMID: 20190786 Review.
In support of the European Union biosimilar framework.
Schneider CK, Borg JJ, Ehmann F, Ekman N, Heinonen E, Ho K, Hoefnagel MH, van der Plas RM, Ruiz S, van der Stappen AJ, Thorpe R, Tiitso K, Tsiftsoglou AS, Vleminckx C, Waxenecker G, Welin M, Weise M, Trouvin JH; Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP); Biologicals Working Party (BWP) of the Committee for Medicinal Products for Human Use (CHMP). Schneider CK, et al. Among authors: ruiz s. Nat Biotechnol. 2012 Aug;30(8):745-8; author reply 748-9. doi: 10.1038/nbt.2322. Nat Biotechnol. 2012. PMID: 22871707 No abstract available.
Meeting Report: 2013 PDA Virus & TSE Safety Forum.
Willkommen H, Blümel J, Brorson K, Chen D, Chen Q, Gröner A, Hubbard BR, Kreil TR, Ruffing M, Ruiz S, Scott D, Silvester G. Willkommen H, et al. Among authors: ruiz s. PDA J Pharm Sci Technol. 2014 May-Jun;68(3):193-214. doi: 10.5731/pdajpst.2014.00980. PDA J Pharm Sci Technol. 2014. PMID: 25188343
920 results