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Added therapeutic benefit and drug licensing.
Eichler HG, Enzmann H, Rasi G. Eichler HG, et al. Among authors: rasi g. Nat Rev Drug Discov. 2019 Sep;18(9):651-652. doi: 10.1038/d41573-019-00068-x. Nat Rev Drug Discov. 2019. PMID: 31477854 No abstract available.
The risks of risk aversion in drug regulation.
Eichler HG, Bloechl-Daum B, Brasseur D, Breckenridge A, Leufkens H, Raine J, Salmonson T, Schneider CK, Rasi G. Eichler HG, et al. Among authors: rasi g. Nat Rev Drug Discov. 2013 Dec;12(12):907-16. doi: 10.1038/nrd4129. Epub 2013 Nov 15. Nat Rev Drug Discov. 2013. PMID: 24232377 Review.
Access to patient-level trial data--a boon to drug developers.
Eichler HG, Pétavy F, Pignatti F, Rasi G. Eichler HG, et al. Among authors: rasi g. N Engl J Med. 2013 Oct 24;369(17):1577-9. doi: 10.1056/NEJMp1310771. Epub 2013 Oct 21. N Engl J Med. 2013. PMID: 24144395 Free article. No abstract available.
How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.
Tafuri G, Pagnini M, Moseley J, Massari M, Petavy F, Behring A, Catalan A, Gajraj E, Hedberg N, Obach M, Osipenko L, Russo P, Van De Casteele M, Zebedin EM, Rasi G, Vamvakas S. Tafuri G, et al. Among authors: rasi g. Br J Clin Pharmacol. 2016 Oct;82(4):965-73. doi: 10.1111/bcp.13023. Epub 2016 Jul 1. Br J Clin Pharmacol. 2016. PMID: 27245362 Free PMC article.
The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.
Tafuri G, Lucas I, Estevão S, Moseley J, d'Andon A, Bruehl H, Gajraj E, Garcia S, Hedberg N, Massari M, Molina A, Obach M, Osipenko L, Petavy F, Petschulies M, Pontes C, Russo P, Schiel A, Van de Casteele M, Zebedin-Brandl EM, Rasi G, Vamvakas S. Tafuri G, et al. Among authors: rasi g. Br J Clin Pharmacol. 2018 May;84(5):1013-1019. doi: 10.1111/bcp.13524. Epub 2018 Mar 5. Br J Clin Pharmacol. 2018. PMID: 29370449 Free PMC article.
107 results