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Data Rich, Information Poor: Can We Use Electronic Health Records to Create a Learning Healthcare System for Pharmaceuticals?
Eichler HG, Bloechl-Daum B, Broich K, Kyrle PA, Oderkirk J, Rasi G, Santos Ivo R, Schuurman A, Senderovitz T, Slawomirski L, Wenzl M, Paris V. Eichler HG, et al. Among authors: rasi g. Clin Pharmacol Ther. 2019 Apr;105(4):912-922. doi: 10.1002/cpt.1226. Epub 2018 Oct 14. Clin Pharmacol Ther. 2019. PMID: 30178490 Free PMC article.
Big Data - How to Realize the Promise.
Cave A, Brun NC, Sweeney F, Rasi G, Senderovitz T; HMA-EMA Joint Big Data Taskforce. Cave A, et al. Among authors: rasi g. Clin Pharmacol Ther. 2020 Apr;107(4):753-761. doi: 10.1002/cpt.1736. Epub 2020 Jan 27. Clin Pharmacol Ther. 2020. PMID: 31846513 Free PMC article.
Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth.
Eichler HG, Pignatti F, Schwarzer-Daum B, Hidalgo-Simon A, Eichler I, Arlett P, Humphreys A, Vamvakas S, Brun N, Rasi G. Eichler HG, et al. Among authors: rasi g. Clin Pharmacol Ther. 2021 May;109(5):1212-1218. doi: 10.1002/cpt.2083. Epub 2020 Nov 12. Clin Pharmacol Ther. 2021. PMID: 33063841 Free PMC article. Review.
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.
Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreements.
Eichler HG, Adams R, Andreassen E, Arlett P, van de Casteele M, Chapman SJ, Goettsch WG, Martinsson JL, Llinares-Garcia J, Nachtnebel A, Pean E, Rasi G, Reksten TR, Timmers L, Vreman RA, van de Vijver I, Wenzl M. Eichler HG, et al. Among authors: rasi g. Int J Technol Assess Health Care. 2021 Aug 23;37(1):e83. doi: 10.1017/S026646232100057X. Int J Technol Assess Health Care. 2021. PMID: 34424152
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.
107 results