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European regulation on orphan medicinal products: 10 years of experience and future perspectives.
Committee for Orphan Medicinal Products and the European Medicines; Westermark K, Holm BB, Söderholm M, Llinares-Garcia J, Rivière F, Aarum S, Butlen-Ducuing F, Tsigkos S, Wilk-Kachlicka A, N'Diamoi C, Borvendég J, Lyons D, Sepodes B, Bloechl-Daum B, Lhoir A, Todorova M, Kkolos I, Kubáčková K, Bosch-Traberg H, Tillmann V, Saano V, Héron E, Elbers R, Siouti M, Eggenhofer J, Salmon P, Clementi M, Krieviņš D, Matulevičiene A, Metz H, Vincenti AC, Voordouw A, Dembowska-Bagińska B, Nunes AC, Saleh FM, Foltánová T, Možina M, Torrent i Farnell J, Beerman B, Mariz S, Evers MP, Greene L, Thorsteinsson S, Gramstad L, Mavris M, Bignami F, Lorence A, Belorgey C. Committee for Orphan Medicinal Products and the European Medicines, et al. Among authors: westermark k. Nat Rev Drug Discov. 2011 May;10(5):341-9. doi: 10.1038/nrd3445. Nat Rev Drug Discov. 2011. PMID: 21532564 Review.
Use of biomarkers in the context of orphan medicines designation in the European Union.
Tsigkos S, Llinares J, Mariz S, Aarum S, Fregonese L, Dembowska-Baginska B, Elbers R, Evers P, Foltanova T, Lhoir A, Corrêa-Nunes A, O'Connor D, Voordouw A, Westermark K, Sepodes B. Tsigkos S, et al. Among authors: westermark k. Orphanet J Rare Dis. 2014 Jan 27;9:13. doi: 10.1186/1750-1172-9-13. Orphanet J Rare Dis. 2014. PMID: 24461084 Free PMC article.
Worldwide collaboration for orphan drug designation.
Mariz S, Reese JH, Westermark K, Greene L, Goto T, Hoshino T, Llinares-Garcia J, Sepodes B. Mariz S, et al. Among authors: westermark k. Nat Rev Drug Discov. 2016 Jun 1;15(6):440-1. doi: 10.1038/nrd.2016.80. Nat Rev Drug Discov. 2016. PMID: 27245396 No abstract available.
Defining orphan conditions in the context of the European orphan regulation: challenges and evolution.
O'Connor DJ, Sheean ME, Hofer MP, Tsigkos S, Mariz S, Fregonese L, Larsson K, Hivert V, Westermark K, Naumann-Winter F, Stoyanova-Beninska V, Barišić I, Capovilla G, Magrelli A, Sepodes B. O'Connor DJ, et al. Among authors: westermark k. Nat Rev Drug Discov. 2019 Jul;18(7):479-480. doi: 10.1038/nrd.2018.128. Nat Rev Drug Discov. 2019. PMID: 30940922 No abstract available.
Orphan drugs. EU regulations.
Mariz S, Llinares J, Westermark K. Mariz S, et al. Among authors: westermark k. BMJ. 2011 Jan 11;342:d136. doi: 10.1136/bmj.d136. BMJ. 2011. PMID: 21224321 No abstract available.
54 results