Zobrazeno 1 - 10
of 79
pro vyhledávání: '"Xavier Kurz"'
Publikováno v:
Frontiers in Pharmacology, Vol 13 (2022)
Between 2000 and 2021, the European Medicines Agency (EMA) assigned the orphan designation to over 1,900 medicines. Due to their small target populations, leading to challenges regarding clinical trial recruitment, study design and little knowledge o
Externí odkaz:
https://doaj.org/article/c8802a5bb27f4f60947bf5660b93552c
Publikováno v:
BMC Medicine, Vol 16, Iss 1, Pp 1-14 (2018)
Abstract Background Antidepressant exposure during pregnancy has been associated with an increased risk of autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in several observational studies. We performed a systematic
Externí odkaz:
https://doaj.org/article/636402234e73490ca9a39d303dfba7e9
Publikováno v:
BMC Medicine, Vol 15, Iss 1, Pp 1-13 (2017)
Abstract Background The benefit-risk balance of vaccines is regularly debated by the public, but the utility of media monitoring for regulatory bodies is unclear. A media monitoring study was conducted at the European Medicines Agency (EMA) concernin
Externí odkaz:
https://doaj.org/article/5ac3222498034a34b17e6a61a07cd6bf
Autor:
Elisabeth Bakker, Kelly Plueschke, Carla J. Jonker, Xavier Kurz, Viktoriia Starokozhko, Peter G. M. Mol
Publikováno v:
Clinical Pharmacology & Therapeutics, 113(1), 135-151. Nature Publishing Group
Real-world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribution has been recognized for safety monitoring and disease epidemiology across medicines' life cycle
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9d12ce57148839066800fb07819fe443
https://doi.org/10.1002/cpt.2766
https://doi.org/10.1002/cpt.2766
Publikováno v:
Drug Safety. 45:747-754
As patient registries are not subject to regulatory requirements on the collection of adverse events (AEs) related to medicinal products, they may not have foreseen the collection of such information on a routine basis or as part of specific data col
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::89e1945f27d5b84f9be8c6cf183adfdc
https://doi.org/10.1007/s40264-022-01188-x
https://doi.org/10.1007/s40264-022-01188-x
Publikováno v:
Pharmacoepidemiology and Drug Safety.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::87d9f23ad04e2b4ae865bd155b9cf3ce
https://doi.org/10.1002/pds.5631
https://doi.org/10.1002/pds.5631
Publikováno v:
European Journal of Clinical Pharmacology.
Purpose Regulators are increasingly concerned with the impact of recalls on drug adherence. In 2018, N-nitrosamines impurities were detected in valsartan containing medical products. Concerned products were immediately recalled in July 2018 by regula
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::fa1f38dee9143f5cc12c9bf9f5da1c32
https://doi.org/10.1007/s00228-022-03439-3
https://doi.org/10.1007/s00228-022-03439-3
Autor:
Luis Correia Pinheiro, Xavier Kurz
Publikováno v:
Pharmacoepidemiology and Drug Safety. 31:1308-1310
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1edb4102d7200c123fa79295a57ad780
https://doi.org/10.1002/pds.5524
https://doi.org/10.1002/pds.5524
Autor:
Jim Slattery, Gianmario Candore, Xavier Kurz, Alexandra Pacurariu, Robert W. V. Flynn, Karin Hedenmalm
Publikováno v:
Drug Safety. 44:973-985
The analgesic metamizole, which has been withdrawn from the market in several countries due to the risk of agranulocytosis but is still available on the market in Germany and some other countries, has been associated with liver injury in published ca
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::016323270e8a6ebeb0036e85ea8c4140
https://doi.org/10.1007/s40264-021-01087-7
https://doi.org/10.1007/s40264-021-01087-7
Autor:
Maarit H Kokki, Lina Titievsky, Miriam C. J. M. Sturkenboom, Simon de Lusignan, Patrick Mahy, Susan Hahné, Vincent Bauchau, Heidi J. Larson, Alena Khromava, Laurence Torcel-Pagnon, Tyra Grove Krause, Antonella Chiucchiuini, Piotr Kramarz, Xavier Kurz, Priya Bahri
Publikováno v:
Vaccine. 38:B1-B7
The influenza A/H1N1 pandemic in 2009 taught us that the monitoring of vaccine benefits and risks in Europe had potential for improvement if different public and private stakeholders would collaborate better (public health institutes (PHIs), regulato
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::58db55085ee198063f2fffa73431fe2e
https://doi.org/10.1016/j.vaccine.2019.07.081
https://doi.org/10.1016/j.vaccine.2019.07.081