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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. Among authors: makady a. 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.
Are CAR-T therapies living up to their hype? A study using real-world data in two cohorts to determine how well they are actually working in practice compared with bone marrow transplants.
Schulthess D, Gassull D, Makady A, Ludlow A, Rothman B, Have PT, Wu Y, Ekstrom L, Minnema M, Jagasia M. Schulthess D, et al. Among authors: makady a. BMJ Evid Based Med. 2021 Jun;26(3):98-102. doi: 10.1136/bmjebm-2019-111226. Epub 2019 Jul 17. BMJ Evid Based Med. 2021. PMID: 31315904 Free PMC article.
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