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Early market access of cancer drugs in the EU.
Martinalbo J, Bowen D, Camarero J, Chapelin M, Démolis P, Foggi P, Jonsson B, Llinares J, Moreau A, O'Connor D, Oliveira J, Vamvakas S, Pignatti F. Martinalbo J, et al. Among authors: vamvakas s. Ann Oncol. 2016 Jan;27(1):96-105. doi: 10.1093/annonc/mdv506. Epub 2015 Oct 20. Ann Oncol. 2016. PMID: 26487583 Free 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: vamvakas s. 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.
Qualification opinion of novel methodologies in the predementia stage of Alzheimer's disease: cerebro-spinal-fluid related biomarkers for drugs affecting amyloid burden--regulatory considerations by European Medicines Agency focusing in improving benefit/risk in regulatory trials.
Isaac M, Vamvakas S, Abadie E, Jonsson B, Gispen C, Pani L. Isaac M, et al. Among authors: vamvakas s. Eur Neuropsychopharmacol. 2011 Nov;21(11):781-8. doi: 10.1016/j.euroneuro.2011.08.003. Epub 2011 Sep 7. Eur Neuropsychopharmacol. 2011. PMID: 21903360
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: vamvakas s. 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.
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: vamvakas s. 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.
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.
Moseley J, Vamvakas S, Berntgen M, Cave A, Kurz X, Arlett P, Acha V, Bennett S, Cohet C, Corriol-Rohou S, Du Four E, Lamoril C, Langeneckert A, Koban M, Pasté M, Sandler S, Van Baelen K, Cangini A, García S, Obach M, Gimenez Garcia E, Varela Lema L, Jauhonen HM, Rannanheimo P, Morrison D, Van De Casteele M, Strömgren A, Viberg A, Makady A, Guilhaume C. Moseley J, et al. Among authors: vamvakas s. Br J Clin Pharmacol. 2020 Jun;86(6):1034-1051. doi: 10.1111/bcp.14279. Epub 2020 Apr 24. Br J Clin Pharmacol. 2020. PMID: 32162368 Free PMC article. Review.
145 results