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Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018.
Sultana J, Crisafulli S, Almas M, Antonazzo IC, Baan E, Bartolini C, Bertuccio MP, Bonifazi F, Capuano A, Didio A, Ehrenstein V, Felisi M, Ferrajolo C, Fontana A, Francisca R, Fourrier-Reglat A, Fortuny J, Gini R, Hyeraci G, Hoeve C, Kontogiorgis C, Isgrò V, Lalagkas PN, L'Abbate L, Layton D, Landi A, Narduzzi S, Roque Pereira L, Poulentzas G, Rafaniello C, Roberto G, Scondotto G, Sportiello L, Toma M, Toussi M, Verhamme K, Volpe E, Trifirò G; On behalf the Working Group 3 of ENCePP (Inventory of EU data sources and methodological approaches for multisource studies). Sultana J, et al. Among authors: bonifazi f. Pharmacoepidemiol Drug Saf. 2022 Jun;31(6):689-705. doi: 10.1002/pds.5413. Epub 2022 Feb 11. Pharmacoepidemiol Drug Saf. 2022. PMID: 35092329 Free PMC article.
Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.
Giannuzzi V, Landi A, Bosone E, Giannuzzi F, Nicotri S, Torrent-Farnell J, Bonifazi F, Felisi M, Bonifazi D, Ceci A. Giannuzzi V, et al. Among authors: bonifazi d, bonifazi f. BMJ Open. 2017 Sep 11;7(9):e017358. doi: 10.1136/bmjopen-2017-017358. BMJ Open. 2017. PMID: 28893754 Free PMC article.
Survey by TEDDY European Network of Excellence for Paediatric Clinical Research demonstrates potential for Europe-wide trials.
Ruggieri L, Bonifazi D, Landi A, Bonifazi F, Bartoloni F, Costello M, Felisi MG, Gasthuys E, Godo A, Martinon Torres F, Nadal D, Nuytinck L, Rocchi F, Turner M, Ceci A. Ruggieri L, et al. Among authors: bonifazi d, bonifazi f. Acta Paediatr. 2020 Mar;109(3):607-612. doi: 10.1111/apa.15020. Epub 2019 Oct 13. Acta Paediatr. 2020. PMID: 31532836
Paediatric Medicines in Europe: The Paediatric Regulation-Is It Time for Reform?
Toma M, Felisi M, Bonifazi D, Bonifazi F, Giannuzzi V, Reggiardo G, de Wildt S, Ceci A; TEDDY European Network of Excellence for Paediatric Research. Toma M, et al. Among authors: bonifazi d, bonifazi f. Front Med (Lausanne). 2021 Feb 2;8:593281. doi: 10.3389/fmed.2021.593281. eCollection 2021. Front Med (Lausanne). 2021. PMID: 33604345 Free PMC article.
Successful private-public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines.
Ruggieri L, Giannuzzi V, Baiardi P, Bonifazi F, Davies EH, Giaquinto C, Bonifazi D, Felisi M, Chiron C, Pressler R, Rabe H, Whitaker MJ, Neubert A, Jacqz-Aigrain E, Eichler I, Turner MA, Ceci A; GRiP Consortium. Ruggieri L, et al. Among authors: bonifazi d, bonifazi f. Eur J Pediatr. 2015 Apr;174(4):481-91. doi: 10.1007/s00431-014-2398-z. Epub 2014 Sep 23. Eur J Pediatr. 2015. PMID: 25241827 Free PMC article.
322 results