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Page 1
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: robert jl. 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.
Where is industry getting it wrong? A review of quality concerns raised at Day 120 by the Committee For Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products.
Borg JJ, Robert JL, Wade G, Aislaitner G, Pirozynski M, Abadie E, Salmonson T, Vella Bonanno P. Borg JJ, et al. Among authors: robert jl. J Pharm Pharm Sci. 2009;12(2):181-98. doi: 10.18433/j3fw2q. J Pharm Pharm Sci. 2009. PMID: 19732496 Free article.
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: robert jl. Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052. Nat Rev Drug Discov. 2010. PMID: 20190786 Review.
Dehazing Ultrasound Using Diffusion Models.
Stevens TSW, Meral FC, Yu J, Apostolakis IZ, Robert JL, van Sloun RJG. Stevens TSW, et al. Among authors: robert jl. IEEE Trans Med Imaging. 2024 Oct;43(10):3546-3558. doi: 10.1109/TMI.2024.3363460. Epub 2024 Oct 28. IEEE Trans Med Imaging. 2024. PMID: 38324427
Effects of azithromycin and doxycycline on the vaginal microbiota of women with urogenital Chlamydia trachomatis infection: a substudy of the Chlazidoxy randomized controlled trial.
Tamarelle J, Penaud B, Tyssandier B, Guichoux E, de Barbeyrac B, Peuchant O; Chlazidoxy study group. Tamarelle J, et al. Clin Microbiol Infect. 2023 Aug;29(8):1056-1062. doi: 10.1016/j.cmi.2023.04.020. Epub 2023 Apr 24. Clin Microbiol Infect. 2023. PMID: 37100225 Free article. Clinical Trial.
66 results