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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.
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 Review.
Clinical Trials for COVID-19: Can we Better Use the Short Window of Opportunity?
Eichler HG, Cavaleri M, Enzmann H, Scotti F, Sepodes B, Sweeney F, Vamvakas S, Rasi G. Eichler HG, et al. Among authors: vamvakas s. Clin Pharmacol Ther. 2020 Oct;108(4):730-733. doi: 10.1002/cpt.1891. Epub 2020 Jun 12. Clin Pharmacol Ther. 2020. PMID: 32407539 Free PMC article. Review.
Digital technologies for medicines: shaping a framework for success.
Cerreta F, Ritzhaupt A, Metcalfe T, Askin S, Duarte J, Berntgen M, Vamvakas S. Cerreta F, et al. Among authors: vamvakas s. Nat Rev Drug Discov. 2020 Sep;19(9):573-574. doi: 10.1038/d41573-020-00080-6. Nat Rev Drug Discov. 2020. PMID: 32398879 No abstract available.
Biomarkers in Progressive Chronic Kidney Disease. Still a Long Way to Go.
Ntrinias T, Papasotiriou M, Balta L, Kalavrizioti D, Vamvakas S, Papachristou E, Goumenos DS. Ntrinias T, et al. Among authors: vamvakas s. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2019 Dec 1;40(3):27-39. doi: 10.2478/prilozi-2020-0002. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2019. PMID: 32109222 Free article. Review.
The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson's Disease.
Stephenson D, Hill D, Cedarbaum JM, Tome M, Vamvakas S, Romero K, Conrado DJ, Dexter DT, Seibyl J, Jennings D, Nicholas T, Matthews D, Xie Z, Imam S, Maguire P, Russell D, Gordon MF, Stebbins GT, Somer E, Gallagher J, Roach A, Basseches P, Grosset D, Marek K; Critical Path for Parkinson’s Consortium. Stephenson D, et al. Among authors: vamvakas s. J Parkinsons Dis. 2019;9(4):825. doi: 10.3233/JPD-199003. J Parkinsons Dis. 2019. PMID: 31524182 Free PMC article. No abstract available.
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