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Page 1
Commentary on the MID3 Good Practices Paper.
Manolis E, Brogren J, Cole S, Hay JL, Nordmark A, Karlsson KE, Lentz F, Benda N, Wangorsch G, Pons G, Zhao W, Gigante V, Serone F, Standing JF, Dokoumetzidis A, Vakkilainen J, van den Heuvel M, Mangas Sanjuan V, Taminiau J, Kerwash E, Khan D, Musuamba FT, Skottheim Rusten I; EMA Modelling and Simulation Working Group. Manolis E, et al. CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):416-417. doi: 10.1002/psp4.12223. Epub 2017 Jul 22. CPT Pharmacometrics Syst Pharmacol. 2017. PMID: 28653481 Free PMC article.
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. Among authors: manolis e. 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.
Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges.
Musuamba FT, Bursi R, Manolis E, Karlsson K, Kulesza A, Courcelles E, Boissel JP, Lesage R, Crozatier C, Voisin EM, Rousseau CF, Marchal T, Alessandrello R, Geris L. Musuamba FT, et al. Among authors: manolis e. CPT Pharmacometrics Syst Pharmacol. 2020 Apr;9(4):195-197. doi: 10.1002/psp4.12504. Epub 2020 Apr 1. CPT Pharmacometrics Syst Pharmacol. 2020. PMID: 32237207 Free PMC article. No abstract available.
Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility.
Musuamba FT, Skottheim Rusten I, Lesage R, Russo G, Bursi R, Emili L, Wangorsch G, Manolis E, Karlsson KE, Kulesza A, Courcelles E, Boissel JP, Rousseau CF, Voisin EM, Alessandrello R, Curado N, Dall'ara E, Rodriguez B, Pappalardo F, Geris L. Musuamba FT, et al. Among authors: manolis e. CPT Pharmacometrics Syst Pharmacol. 2021 Aug;10(8):804-825. doi: 10.1002/psp4.12669. Epub 2021 Jul 13. CPT Pharmacometrics Syst Pharmacol. 2021. PMID: 34102034 Free PMC article.
Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective.
Manolis E, García-Arieta A, Lindahl A, Kotzagiorgis E, Limberg J, Holte Ø, Paixao P, Versantvoort C, Tshinanu FM, Blake K, Van Den Heuvel M. Manolis E, et al. CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):556-559. doi: 10.1002/psp4.12906. Epub 2023 Jan 11. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36628987 Free PMC article. No abstract available.
Model-Informed Drug Development: Steps Toward Harmonized Guidance.
Marshall S, Ahamadi M, Chien J, Iwata D, Farkas P, Filipe A, Frey N, Greene E, Kawai N, Li J, Lippert J, Musuamba Tshinanu F, Manolis E, Peterson MC, Sarem S, Shebley M, Tegenge M, Tsai CH, Tu CL, Otsubo Y, Wei J, Zhang L, Zhu H, Karlsson KE. Marshall S, et al. Among authors: manolis e. Clin Pharmacol Ther. 2023 Nov;114(5):954-959. doi: 10.1002/cpt.3006. Epub 2023 Aug 3. Clin Pharmacol Ther. 2023. PMID: 37534711 No abstract available.
70 results