Zobrazeno 1 - 6
of 6
pro vyhledávání: '"Lourens T Bloem"'
Autor:
Gabe S Sonke, Amos J de Jong, Lourens T Bloem, Christine C van Hattem, Jolien S de Groot, Jarno Hoekman, K Esther Broekman, Paula B van Hennik
Publikováno v:
BMJ Open, Vol 14, Iss 11 (2024)
Objective The collection of comprehensive data from post-authorisation trials for conditionally authorised anticancer medicines is frequently delayed. This raises questions about the feasibility of post-authorisation randomised controlled trials (RCT
Externí odkaz:
https://doaj.org/article/4fe87bd87ee346fdb277817cb56dabf2
Autor:
Rick A. Vreman, Lourens T. Bloem, Stijn van Oirschot, Jarno Hoekman, Menno E. van der Elst, Hubert GM Leufkens, Olaf H. Klungel, Wim G. Goettsch, Aukje K. Mantel-Teeuwisse
Publikováno v:
International Journal of Health Policy and Management, Vol 11, Iss 5, Pp 642-650 (2022)
BackgroundThe European Medicines Agency (EMA) aims to resolve uncertainties associated with conditionally approved drugs by imposing post-approval studies. Results from these studies may be relevant for health technology assessment (HTA) organization
Externí odkaz:
https://doaj.org/article/b08a5601b3234a34901de533ff590f12
Autor:
Lourens T. Bloem, Rick A. Vreman, Niels W. L. Peeters, Jarno Hoekman, Menno E. van derElst, Hubert G. M. Leufkens, Olaf H. Klungel, Wim G. Goettsch, Aukje K. Mantel‐Teeuwisse
Publikováno v:
Clinical and Translational Science, Vol 14, Iss 4, Pp 1566-1577 (2021)
Abstract We aimed to determine whether uncertainties identified by the European Medicines Agency (EMA) were associated with negative relative effectiveness assessments (REAs) and negative overall reimbursement recommendations by national health techn
Externí odkaz:
https://doaj.org/article/a2e8481c77804dc8b050c8e96f840417
Autor:
Lourens T. Bloem, Jasmin Schelhaas, Lucía López‐Anglada, Carla Herberts, Paula B. van Hennik, Olli Tenhunen
Since 2006, the European conditional marketing authorization (CMA) aims to facilitate timely patient access to medicinal products for which there is an unmet medical need by accepting less comprehensive data than normally required. The granting of CM
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4135e212be33e6200812c4b1f281a967
https://dspace.library.uu.nl/handle/1874/429487
https://dspace.library.uu.nl/handle/1874/429487
Autor:
Chiel F, Ebbelaar, Anne M R, Schrader, Marijke, van Dijk, Ruud W J, Meijers, Wendy W J, de Leng, Lourens T, Bloem, Anne M L, Jansen, Willeke A M, Blokx
Publikováno v:
Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc. 35(8)
Cutaneous deep penetrating melanocytic neoplasms frequently simulate melanoma and might occasionally progress to metastatic melanoma. Distinguishing deep penetrating nevi (DPN) and deep penetrating melanocytomas (DPM) from malignant deep penetrating
Autor:
Mariia V. Maksimova, Ghislaine J. M. W. van Thiel, Yke Tromp, Rosan Lechner, Johannes J. M. van Delden, Lourens T. Bloem
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
The European Medicines Agency’s conditional marketing authorization (CMA) aims to expedite patient access to medicines for unmet medical needs by shifting a part of the drug development process post-authorization. We highlight ethical issues surrou
Externí odkaz:
https://doaj.org/article/07f3fa560b54482783616b74dd73c243