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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: timon m. Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052. Nat Rev Drug Discov. 2010. PMID: 20190786 Review.
Allergen manufacturing and quality aspects for allergen immunotherapy in Europe and the United States: An analysis from the EAACI AIT Guidelines Project.
Bonertz A, Roberts G, Slater JE, Bridgewater J, Rabin RL, Hoefnagel M, Timon M, Pini C, Pfaar O, Sheikh A, Ryan D, Akdis C, Goldstein J, Poulsen LK, van Ree R, Rhyner C, Barber D, Palomares O, Pawankar R, Hamerlijnk D, Klimek L, Agache I, Angier E, Casale T, Fernandez-Rivas M, Halken S, Jutel M, Lau S, Pajno G, Sturm G, Varga EM, Gerth van Wijk R, Bonini S, Muraro A, Vieths S. Bonertz A, et al. Among authors: timon m. Allergy. 2018 Apr;73(4):816-826. doi: 10.1111/all.13357. Epub 2018 Jan 10. Allergy. 2018. PMID: 29150848 Free article. Review.
Challenges in the implementation of EAACI guidelines on allergen immunotherapy: A global perspective on the regulation of allergen products.
Bonertz A, Roberts GC, Hoefnagel M, Timon M, Slater JE, Rabin RL, Bridgewater J, Pini C, Pfaar O, Akdis C, Goldstein J, Poulsen LK, van Ree R, Rhyner C, Barber D, Palomares O, Sheikh A, Pawankar R, Hamerlijnk D, Klimek L, Agache I, Angier E, Casale T, Fernandez-Rivas M, Halken S, Jutel M, Lau S, Pajno G, Sturm G, Varga EM, Gerth van Wijk R, Bonini S, Muraro A, Vieths S. Bonertz A, et al. Among authors: timon m. Allergy. 2018 Jan;73(1):64-76. doi: 10.1111/all.13266. Epub 2017 Aug 30. Allergy. 2018. PMID: 28771830 Free article. Review.
The harmonization of World Health Organization International Nonproprietary Names definitions for cell and cell-based gene therapy substances: when a name is not enough.
Loizides U, Dominici M, Manderson T, Rizzi M, Robertson JS, de Sousa Guimarães Koch S, Timón M, Balocco R. Loizides U, et al. Among authors: timon m. Cytotherapy. 2021 May;23(5):357-366. doi: 10.1016/j.jcyt.2021.02.114. Epub 2021 Apr 2. Cytotherapy. 2021. PMID: 33820700 Free PMC article. Review.
54 results