1
TITLE: Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases  Full Text
AUTHORS: Maria E Sheean; Eva Malikova; Dinah Duarte; Giuseppe Capovilla; Laura Fregonese; Matthias P Hofer; Armando Magrelli; Segundo Mariz; Fernando Mendez Hermida; Robert Nistico; Tim Leest; Nikolaos V Sipsas; Stelios Tsigkos; Dinko Vitezic; Kristina Larsson; Bruno Sepodes; Violeta Stoyanova Beninska;
PUBLISHED: 2020, SOURCE: DRUG DISCOVERY TODAY, VOLUME: 25, ISSUE: 2
INDEXED IN: Scopus WOS
2
TITLE: Designation of orphan conditions in Europe: regulatory observations and considerations after implementation of regulation 141/2000
AUTHORS: Segundo Mariz; Kerstin Westermark; Bruno Sepodes;
PUBLISHED: 2020, SOURCE: EXPERT OPINION ON ORPHAN DRUGS, VOLUME: 8, ISSUE: 6
INDEXED IN: Scopus WOS
3
TITLE: Defining orphan conditions in the context of the European orphan regulation: challenges and evolution
AUTHORS: Daniel J O'Connor; Maria E Sheean; Matthias P Hofer; Stelios Tsigkos; Segundo Mariz; Laura Fregonese; Kristina Larsson; Virginie Hivert; Kerstin Westermark; Frauke Naumann Winter; Violeta Stoyanova Beninska; Ingeborg Barisic; Giuseppe Capovilla; Armando Magrelli; Bruno Sepodes;
PUBLISHED: 2019, SOURCE: NATURE REVIEWS DRUG DISCOVERY, VOLUME: 18, ISSUE: 7
INDEXED IN: WOS
4
TITLE: Establishing rarity in the context of orphan medicinal product designation in the European Union  Full Text
AUTHORS: Stelios Tsigkos; Matthias Philipp Hofer; Maria Elzbieta Sheean; Segundo Mariz; Kristina Larsson; Frauke Naumann Winter; Laura Fregonese; Bruno Sepodes;
PUBLISHED: 2018, SOURCE: DRUG DISCOVERY TODAY, VOLUME: 23, ISSUE: 3
INDEXED IN: WOS
5
TITLE: Comparative analysis of the scope of European Union paediatric investigation plans with corresponding orphan designations
AUTHORS: Andrea Ecker; Segundo Mariz; Frauke Naumann Winter; Koenraad Norga; Ingeborg Barisic; Thomas Girard; Paolo Tomasi; Dirk Mentzer; Bruno Sepodes;
PUBLISHED: 2018, SOURCE: ARCHIVES OF DISEASE IN CHILDHOOD, VOLUME: 103, ISSUE: 5
INDEXED IN: Scopus WOS
6
TITLE: Evolving prevalence of haematological malignancies in orphan designation procedures in the European Union  Full Text
AUTHORS: Benedetta Polsinelli; Stelios Tsigkos; Frauke Naumann Winter; Segundo Mariz; Bruno Sepodes;
PUBLISHED: 2017, SOURCE: ORPHANET JOURNAL OF RARE DISEASES, VOLUME: 12, ISSUE: 1
INDEXED IN: Scopus WOS
7
TITLE: The orphan drug pipeline in Europe
AUTHORS: Thomas Morel; Eline Picavet; Andre Lhoir; Jordi Llinares; Segundo Mariz; Bruno Sepodes; David Cassiman;
PUBLISHED: 2016, SOURCE: NATURE REVIEWS DRUG DISCOVERY, VOLUME: 15, ISSUE: 6
INDEXED IN: WOS
8
TITLE: Worldwide collaboration for orphan drug designation
AUTHORS: Segundo Mariz; James H Reese; Kerstin Westermark; Lesley Greene; Takahiro Goto; Tatsuro Hoshino; Jordi Llinares Garcia; Bruno Sepodes;
PUBLISHED: 2016, SOURCE: NATURE REVIEWS DRUG DISCOVERY, VOLUME: 15, ISSUE: 6
INDEXED IN: Scopus WOS CrossRef
9
TITLE: Erratum to: Establishing medical plausibility in the context of orphan medicines designation in the European Union  Full Text
AUTHORS: Stelios Tsigkos; Segundo Mariz; Jordi Llinares; Laura Fregonese; Stiina Aarum; Frauke Naumann-Winter; Kerstin Westermark; Bruno Sepodes;
PUBLISHED: 2015, SOURCE: Orphanet Journal of Rare Diseases - Orphanet J Rare Dis, VOLUME: 10, ISSUE: 1
INDEXED IN: CrossRef
10
TITLE: Establishing medical plausibility in the context of orphan medicines designation in the European Union (vol 9, 175, 2014)  Full Text
AUTHORS: Stelios Tsigkos; Segundo Mariz; Jordi Llinares; Laura Fregonese; Stiina Aarum; Frauke Naumann Winter; Kerstin Westermark; Bruno Sepodes;
PUBLISHED: 2015, SOURCE: ORPHANET JOURNAL OF RARE DISEASES, VOLUME: 10
INDEXED IN: WOS
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