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Page 1
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.
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.
Open clinical trial data for all? A view from regulators.
Eichler HG, Abadie E, Breckenridge A, Leufkens H, Rasi G. Eichler HG, et al. Among authors: rasi g. PLoS Med. 2012;9(4):e1001202. doi: 10.1371/journal.pmed.1001202. Epub 2012 Apr 10. PLoS Med. 2012. PMID: 22505851 Free PMC article.
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.
From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.
Eichler HG, Baird LG, Barker R, Bloechl-Daum B, Børlum-Kristensen F, Brown J, Chua R, Del Signore S, Dugan U, Ferguson J, Garner S, Goettsch W, Haigh J, Honig P, Hoos A, Huckle P, Kondo T, Le Cam Y, Leufkens H, Lim R, Longson C, Lumpkin M, Maraganore J, O'Rourke B, Oye K, Pezalla E, Pignatti F, Raine J, Rasi G, Salmonson T, Samaha D, Schneeweiss S, Siviero PD, Skinner M, Teagarden JR, Tominaga T, Trusheim MR, Tunis S, Unger TF, Vamvakas S, Hirsch G. Eichler HG, et al. Among authors: rasi g. Clin Pharmacol Ther. 2015 Mar;97(3):234-46. doi: 10.1002/cpt.59. Epub 2015 Feb 4. Clin Pharmacol Ther. 2015. PMID: 25669457 Free PMC article.
107 results