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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: benchetrit s. Br J Pharmacol. 2024 Nov 22. doi: 10.1111/bph.17396. Online ahead of print. Br J Pharmacol. 2024. PMID: 39574299 Review.
European regulatory strategy for supporting childhood cancer therapy developments.
Karres D, Lesa G, Ligas F, Benchetrit S, Galluzzo S, Van Malderen K, Sterba J, van Dartel M, Renard M, Sisovsky P, Wang S, Norga K. Karres D, et al. Among authors: benchetrit s. Eur J Cancer. 2022 Dec;177:25-29. doi: 10.1016/j.ejca.2022.09.025. Epub 2022 Oct 6. Eur J Cancer. 2022. PMID: 36323049 Free article.
Paediatric Strategy Forum for medicinal product development of DNA damage response pathway inhibitors in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson ADJ, Federico S, Gatz SA, Ortiz M, Lesa G, Scobie N, Gounaris I, Weiner SL, Weigel B, Unger TJ, Stewart E, Smith M, Slotkin EK, Reaman G, Pappo A, Nysom K, Norga K, McDonough J, Marshall LV, Ludwinski D, Ligas F, Karres D, Kool M, Horner TJ, Henssen A, Heenen D, Hawkins DS, Gore L, Bender JG, Galluzzo S, Fox E, de Rojas T, Davies BR, Chakrabarti J, Carmichael J, Bradford D, Blanc P, Bernardi R, Benchetrit S, Akindele K, Vassal G. Pearson ADJ, et al. Among authors: benchetrit s. Eur J Cancer. 2023 Sep;190:112950. doi: 10.1016/j.ejca.2023.112950. Epub 2023 Jun 21. Eur J Cancer. 2023. PMID: 37441939 Free article. Review.
Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases.
Prilla S, Groeneveld S, Pacurariu A, Restrepo-Méndez MC, Verpillat P, Torre C, Gartner C, Mol PGM, Naumann-Winter F, Breen KC, Gault N, Gross-Martirosyan L, Benchetrit S, Aylward B, Stoyanova-Beninska V, O'Donovan M, Straus S, Kjaer J, Arlett P. Prilla S, et al. Among authors: benchetrit s. Clin Pharmacol Ther. 2024 Nov;116(5):1188-1197. doi: 10.1002/cpt.3355. Epub 2024 Jul 4. Clin Pharmacol Ther. 2024. PMID: 38962830 Review.
The Patient's Perspective: Does It Align with Dialysis Adequacy?
Cohen-Hagai K, Kitani A, Benchetrit S, Erez D, Alon A, Wilf-Miron R, Saban M. Cohen-Hagai K, et al. Among authors: benchetrit s. Kidney360. 2024 Aug 1;5(8):1137-1144. doi: 10.34067/KID.0000000000000505. Epub 2024 Jul 12. Kidney360. 2024. PMID: 38995698 Free PMC article.
140 results