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Evidence generation throughout paediatric medicines life cycle: findings from collaborative work between European Medicines Agency (EMA) and EUnetHTA on use of extrapolation.
Karres D, Pino-Barrio MJ, Benchetrit S, Benda N, Cochat P, Galluzzo S, García-Solís A, Gonzalez S, de Lisa R, Khan D, Lankester R, Lentz F, Martínez-Ortega PA, Montilla S, Morales DR, Tshinanu FM, Sánchez SP, Montero AR, Scherer S, Thomson A, Garrido BT, Umuhire D, Wang S, Bax R, Hedberg N. Karres D, et al. Among authors: tshinanu fm. Br J Pharmacol. 2024 Nov 22. doi: 10.1111/bph.17396. Online ahead of print. Br J Pharmacol. 2024. PMID: 39574299 Review.
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. Among authors: tshinanu fm. 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.
In silico clinical trials: concepts and early adoptions.
Pappalardo F, Russo G, Tshinanu FM, Viceconti M. Pappalardo F, et al. Among authors: tshinanu fm. Brief Bioinform. 2019 Sep 27;20(5):1699-1708. doi: 10.1093/bib/bby043. Brief Bioinform. 2019. PMID: 29868882 Review.