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Editorial: Reviews in: regulatory science.
Kerpel-Fronius S, Stoyanova-Beninska V, Giannuzzi V, Sun Z. Kerpel-Fronius S, et al. Among authors: stoyanova beninska v. Front Med (Lausanne). 2023 May 16;10:1206753. doi: 10.3389/fmed.2023.1206753. eCollection 2023. Front Med (Lausanne). 2023. PMID: 37261118 Free PMC article. No abstract available.
European Medicines Agency review of ataluren for the treatment of ambulant patients aged 5 years and older with Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene.
Haas M, Vlcek V, Balabanov P, Salmonson T, Bakchine S, Markey G, Weise M, Schlosser-Weber G, Brohmann H, Yerro CP, Mendizabal MR, Stoyanova-Beninska V, Hillege HL. Haas M, et al. Neuromuscul Disord. 2015 Jan;25(1):5-13. doi: 10.1016/j.nmd.2014.11.011. Epub 2014 Nov 24. Neuromuscul Disord. 2015. PMID: 25497400 No abstract available.
Stakeholder cooperation to overcome challenges in orphan medicine development: the example of Duchenne muscular dystrophy.
Straub V, Balabanov P, Bushby K, Ensini M, Goemans N, De Luca A, Pereda A, Hemmings R, Campion G, Kaye E, Arechavala-Gomeza V, Goyenvalle A, Niks E, Veldhuizen O, Furlong P, Stoyanova-Beninska V, Wood MJ, Johnson A, Mercuri E, Muntoni F, Sepodes B, Haas M, Vroom E, Aartsma-Rus A. Straub V, et al. Lancet Neurol. 2016 Jul;15(8):882-890. doi: 10.1016/S1474-4422(16)30035-7. Lancet Neurol. 2016. PMID: 27302365 Review.
Nonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditions.
Sheean ME, Stoyanova-Beninska V, Capovilla G, Duarte D, Hofer MP, Hoffmann M, Magrelli A, Mariz S, Tsigkos S, Shaili E, Polsinelli B, Ricciardi M, Bonelli M, Balabanov P, Larsson K, Sepodes B. Sheean ME, et al. Drug Discov Today. 2018 Jan;23(1):26-48. doi: 10.1016/j.drudis.2017.09.015. Epub 2017 Oct 4. Drug Discov Today. 2018. PMID: 28987289 Review.
Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases.
Sheean ME, Malikova E, Duarte D, Capovilla G, Fregonese L, Hofer MP, Magrelli A, Mariz S, Mendez-Hermida F, Nistico R, Leest T, Sipsas NV, Tsigkos S, Vitezic D, Larsson K, Sepodes B, Stoyanova-Beninska V. Sheean ME, et al. Drug Discov Today. 2020 Feb;25(2):274-291. doi: 10.1016/j.drudis.2019.10.015. Epub 2019 Nov 5. Drug Discov Today. 2020. PMID: 31704277 Free article. Review.
Can a Multistakeholder Prioritization Structure Support Regulatory Decision Making? A Review of Pediatric Oncology Strategy Forums Reflecting on Challenges and Opportunities of this Concept.
Karres D, Lesa G, Ligas F, Annunen P, van Dartel M, Demolis P, Galluzzo S, Herold R, van Criekingen OK, Stoyanova-Beninska V, Norga K. Karres D, et al. Clin Pharmacol Ther. 2020 Sep;108(3):553-556. doi: 10.1002/cpt.1939. Epub 2020 Jul 8. Clin Pharmacol Ther. 2020. PMID: 32559312 Review.
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