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Medicines for an aging population: The EMA perspective and policies.
Cerreta F, Iskra EB, Cupelli A, Sepodes B, Rönnemaa E, Rosa MM, Mayrhofer S, Trauffler M, Torre C, Berntgen M, Vucic K, Bahri P, Koch A, Herdeiro MT, Mirošević Skvrce N, Pallos J, Laslop A. Cerreta F, et al. J Am Geriatr Soc. 2024 May 17. doi: 10.1111/jgs.18953. Online ahead of print. J Am Geriatr Soc. 2024. PMID: 38757979
Inclusion of functional measures and frailty in the development and evaluation of medicines for older adults.
Denkinger M, Knol W, Cherubini A, Simonds A, Lionis C, Lacombe D, Petelos E, McCarthy M, Ouvrard P, Van Kerrebroeck P, Szymański P, Cupelli A, Laslop A, Koch A, Sepodes B, Torre C, Rönnemaa E, Bałkowiec-Iskra E, Herdeiro MT, Rosa MM, Trauffler M, Mirošević Skvrce N, Mayrhofer S, Berntgen M, Silva I, Cerreta F. Denkinger M, et al. Among authors: cerreta f. Lancet Healthy Longev. 2023 Dec;4(12):e724-e729. doi: 10.1016/S2666-7568(23)00208-8. Epub 2023 Nov 15. Lancet Healthy Longev. 2023. PMID: 37977177 Free article. Review.
Evolving regulatory perspectives on digital health technologies for medicinal product development.
Colloud S, Metcalfe T, Askin S, Belachew S, Ammann J, Bos E, Kilchenmann T, Strijbos P, Eggenspieler D, Servais L, Garay C, Konstantakopoulos A, Ritzhaupt A, Vetter T, Vincenzi C, Cerreta F. Colloud S, et al. Among authors: cerreta f. NPJ Digit Med. 2023 Mar 29;6(1):56. doi: 10.1038/s41746-023-00790-2. NPJ Digit Med. 2023. PMID: 36991116 Free PMC article. Review.
Commentary on the EMA reflection paper on the pharmaceutical development of medicines for use in the older population.
van Riet-Nales DA, van den Bemt B, van Bodegom D, Cerreta F, Dooley B, Eggenschwyler D, Hirschlérova B, Jansen PAF, Karapinar-Çarkit F, Moran A, Span J, Stegemann S, Sundberg K. van Riet-Nales DA, et al. Among authors: cerreta f. Br J Clin Pharmacol. 2022 Feb;88(4):1500-1514. doi: 10.1111/bcp.15207. Epub 2022 Feb 9. Br J Clin Pharmacol. 2022. PMID: 35141926 Free article.
First Regulatory Qualification of a Novel Digital Endpoint in Duchenne Muscular Dystrophy: A Multi-Stakeholder Perspective on the Impact for Patients and for Drug Development in Neuromuscular Diseases.
Servais L, Camino E, Clement A, McDonald CM, Lukawy J, Lowes LP, Eggenspieler D, Cerreta F, Strijbos P. Servais L, et al. Among authors: cerreta f. Digit Biomark. 2021 Aug 5;5(2):183-190. doi: 10.1159/000517411. eCollection 2021 May-Aug. Digit Biomark. 2021. PMID: 34723071 Free PMC article. Review.
Roadmap to 2030 for Drug Evaluation in Older Adults.
Liu Q, Schwartz JB, Slattum PW, Lau SWJ, Guinn D, Madabushi R, Burckart G, Califf R, Cerreta F, Cho C, Cook J, Gamerman J, Goldsmith P, van der Graaf PH, Gurwitz JH, Haertter S, Hilmer S, Huang SM, Inouye SK, Kanapuru B, Pirmohamed M, Posner P, Radziszewska B, Keipp Talbot H, Temple R. Liu Q, et al. Among authors: cerreta f. Clin Pharmacol Ther. 2022 Aug;112(2):210-223. doi: 10.1002/cpt.2452. Epub 2021 Nov 8. Clin Pharmacol Ther. 2022. PMID: 34656074
Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults.
Reginster JY, Beaudart C, Al-Daghri N, Avouac B, Bauer J, Bere N, Bruyère O, Cerreta F, Cesari M, Rosa MM, Cooper C, Cruz Jentoft AJ, Dennison E, Geerinck A, Gielen E, Landi F, Laslop A, Maggi S, Prieto Yerro MC, Rizzoli R, Sundseth H, Sieber C, Trombetti A, Vellas B, Veronese N, Visser M, Vlaskovska M, Fielding RA. Reginster JY, et al. Among authors: cerreta f. Aging Clin Exp Res. 2021 Jan;33(1):3-17. doi: 10.1007/s40520-020-01663-4. Epub 2020 Jul 31. Aging Clin Exp Res. 2021. PMID: 32737844 Free PMC article. Review.
27 results