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The evolution of adaptiveness: balancing speed and evidence.
Eichler HG, Barker R, Bedlington N, Bouvy JC, Broekmans AW, Bucsics A, Cerreta F, Corriol-Rohou S, Granados A, Le Cam Y, Schuurman A. Eichler HG, et al. Nat Rev Drug Discov. 2018 Dec;17(12):845-846. doi: 10.1038/nrd.2018.90. Epub 2018 Jul 6. Nat Rev Drug Discov. 2018. PMID: 29977052 No abstract available.
Medicines Adaptive Pathways to Patients: Why, When, and How to Engage?
Eichler HG, Bedlington N, Boudes M, Bouvy JC, Broekmans AW, Cerreta F, Faulkner SD, Forda SR, Joos A, Le Cam Y, Mayer MH, Pirard V, Corriol-Rohou S; ADAPT SMART Consortium. Eichler HG, et al. Clin Pharmacol Ther. 2019 May;105(5):1148-1155. doi: 10.1002/cpt.1121. Epub 2018 Sep 11. Clin Pharmacol Ther. 2019. PMID: 29901216 Free PMC article. Review.
Recognizing that Evidence is Made, not Born.
Lim R, Lee DK, Sabourin P, Ferguson J, Metcalf M, Smith M, Corriol-Rohou S, Eichler HG, Lumpkin M, Hirsch G, Chen IM, O'Rourke B, Schiel A, Crabb N, Aronson N, Pezalla E, Boutin M, Binder L, Wilhelm L. Lim R, et al. Clin Pharmacol Ther. 2019 Apr;105(4):844-856. doi: 10.1002/cpt.1317. Epub 2019 Jan 4. Clin Pharmacol Ther. 2019. PMID: 30472743 Free PMC article.
Shared Learnings on the New EMA First-in-Human and Early Clinical Trial Guideline: Proceedings From a DIAlogue Session at DIA Europe 2018.
van der Laan JW, Benson CT, Janssens W, Bos J, Stahl E, Brady JT, Wändel-Liminga U, Corriol-Rohou S, Forster R, Hartmann A, Pertel PE, Robertson SM, Silva-Lima B, Malik RE, Chibout SD. van der Laan JW, et al. Ther Innov Regul Sci. 2020 Mar;54(2):462-467. doi: 10.1007/s43441-019-00077-3. Epub 2020 Jan 6. Ther Innov Regul Sci. 2020. PMID: 32072587 Clinical Trial.
Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014).
Musuamba FT, Manolis E, Holford N, Cheung S, Friberg LE, Ogungbenro K, Posch M, Yates J, Berry S, Thomas N, Corriol-Rohou S, Bornkamp B, Bretz F, Hooker AC, Van der Graaf PH, Standing JF, Hay J, Cole S, Gigante V, Karlsson K, Dumortier T, Benda N, Serone F, Das S, Brochot A, Ehmann F, Hemmings R, Rusten IS. Musuamba FT, et al. CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):418-429. doi: 10.1002/psp4.12196. Epub 2017 Jul 19. CPT Pharmacometrics Syst Pharmacol. 2017. PMID: 28722322 Free PMC article.
How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement.
Severin T, Corriol-Rohou S, Bucci-Rechtweg C, An Haack K, Fuerst-Recktenwald S, Lepola P, Norjavaara E, Dehlinger-Kremer M; EFGCP Children’s Medicines Working Party; Haertter S, Cheung SYA; IQ Pediatric Working Group. Severin T, et al. Ther Innov Regul Sci. 2020 Sep;54(5):1076-1084. doi: 10.1007/s43441-020-00116-4. Epub 2020 Feb 6. Ther Innov Regul Sci. 2020. PMID: 32030690 Free PMC article.
Orphan Medicines for Pediatric Use: A Focus on the European Union.
Bolislis WR, Corriol-Rohou S, Hill-Venning C, Hoogland H, Joos A, King D, Kitcatt V, Le Visage G, Kühler TC. Bolislis WR, et al. Clin Ther. 2019 Dec;41(12):2630-2642. doi: 10.1016/j.clinthera.2019.10.006. Epub 2019 Nov 5. Clin Ther. 2019. PMID: 31704041 Free 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. 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.
36 results