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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: leufkens h. 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.
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: leufkens h. PLoS Med. 2012;9(4):e1001202. doi: 10.1371/journal.pmed.1001202. Epub 2012 Apr 10. PLoS Med. 2012. PMID: 22505851 Free PMC article.
Factors influencing non-approval of new drugs in Europe.
Putzeist M, Mantel-Teeuwisse AK, Aronsson B, Rowland M, Gispen-de Wied CC, Vamvakas S, Hoes AW, Leufkens HG, Eichler HG. Putzeist M, et al. Nat Rev Drug Discov. 2012 Dec;11(12):903-4. doi: 10.1038/nrd3894. Nat Rev Drug Discov. 2012. PMID: 23197028 No abstract available.
Regulatory evaluation of Glybera in Europe - two committees, one mission.
Melchiorri D, Pani L, Gasparini P, Cossu G, Ancans J, Borg JJ, Drai C, Fiedor P, Flory E, Hudson I, Leufkens HG, Müller-Berghaus J, Narayanan G, Neugebauer B, Pokrotnieks J, Robert JL, Salmonson T, Schneider CK. Melchiorri D, et al. Nat Rev Drug Discov. 2013 Sep;12(9):719. doi: 10.1038/nrd3835-c1. Epub 2013 Aug 19. Nat Rev Drug Discov. 2013. PMID: 23954897 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: leufkens h. 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.
585 results