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Page 1
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: llinares garcia j. Nat Rev Drug Discov. 2011 May;10(5):341-9. doi: 10.1038/nrd3445. Nat Rev Drug Discov. 2011. PMID: 21532564 Review.
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: llinares garcia j. 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.
Identification and validation of biomarkers for autism spectrum disorders.
Loth E, Spooren W, Ham LM, Isaac MB, Auriche-Benichou C, Banaschewski T, Baron-Cohen S, Broich K, Bölte S, Bourgeron T, Charman T, Collier D, de Andres-Trelles F, Durston S, Ecker C, Elferink A, Haberkamp M, Hemmings R, Johnson MH, Jones EJ, Khwaja OS, Lenton S, Mason L, Mantua V, Meyer-Lindenberg A, Lombardo MV, O'Dwyer L, Okamoto K, Pandina GJ, Pani L, Persico AM, Simonoff E, Tauscher-Wisniewski S, Llinares-Garcia J, Vamvakas S, Williams S, Buitelaar JK, Murphy DG. Loth E, et al. Among authors: llinares garcia j. Nat Rev Drug Discov. 2016 Jan;15(1):70-3. doi: 10.1038/nrd.2015.7. Nat Rev Drug Discov. 2016. PMID: 26718285 No abstract available.
Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreements.
Eichler HG, Adams R, Andreassen E, Arlett P, van de Casteele M, Chapman SJ, Goettsch WG, Martinsson JL, Llinares-Garcia J, Nachtnebel A, Pean E, Rasi G, Reksten TR, Timmers L, Vreman RA, van de Vijver I, Wenzl M. Eichler HG, et al. Among authors: llinares garcia j. Int J Technol Assess Health Care. 2021 Aug 23;37(1):e83. doi: 10.1017/S026646232100057X. Int J Technol Assess Health Care. 2021. PMID: 34424152
Therapeutic genome editing: regulatory horizons.
Hines PA, Agricola E, Llinares Garcia J, O'Dwyer L, Herold R. Hines PA, et al. Among authors: llinares garcia j. Nat Rev Drug Discov. 2022 Jan;21(1):1-2. doi: 10.1038/d41573-021-00130-7. Nat Rev Drug Discov. 2022. PMID: 34326503 No abstract available.