Zobrazeno 1 - 10
of 60
pro vyhledávání: '"Tomas, Salmonson"'
Autor:
Myrto Lee, Hugo Larose, Martin Gräbeldinger, Jon Williams, Anne-Marie Baird, Susan Brown, Johannes Bruns, Russell Clark, Javier Cortes, Giuseppe Curigliano, Andrea Ferris, Louis P. Garrison, Y.K. Gupta, Ravindran Kanesvaran, Gary Lyman, Luca Pani, Zack Pemberton-Whiteley, Tomas Salmonson, Peter Sawicki, Barry Stein, Dong-Churl Suh, Galina Velikova, Jens Grueger
Publikováno v:
Health Policy Open, Vol 6, Iss , Pp 100116- (2024)
The move toward early detection and treatment of cancer presents challenges for value assessment using traditional endpoints. Current cancer management rarely considers the full economic and societal benefits of therapies. Our study used a modified D
Externí odkaz:
https://doaj.org/article/e4d6e9cf3a8d4b7d88dee937863945b9
Autor:
Elaine Julian, Mira Pavlovic, Oriol Sola-Morales, Fabrizio Gianfrate, Mondher Toumi, Heiner C. Bucher, Christian Dierks, Wolfgang Greiner, Peter Mol, Jean-François Bergmann, Tomas Salmonson, Ansgar Hebborn, Mathilde Grande, Antonella Cardone, Jörg Ruof
Publikováno v:
Health Economics Review, Vol 12, Iss 1, Pp 1-15 (2022)
Abstract Objectives Key challenges for a joint European Health Technology Assessment (HTA) include consolidated approaches towards the choice of adequate comparator(s), selection of endpoints that are relevant to patients with a given disease, dealin
Externí odkaz:
https://doaj.org/article/49b7e3fc8c3140c6be0c21e052b00350
Autor:
Elaine Julian, Fabrizio Gianfrate, Oriol Sola-Morales, Peter Mol, Jean-François Bergmann, Tomas Salmonson, Ansgar Hebborn, Mathilde Grande, Jörg Ruof
Publikováno v:
Health Economics Review, Vol 12, Iss 1, Pp 1-12 (2022)
Abstract Objectives We conducted a multi-stakeholder survey to determine key areas where a joint European health technology assessment (HTA) could provide ‘additional benefit’ compared to the status quo of many parallel independent national and s
Externí odkaz:
https://doaj.org/article/2ba07948754a4eed9306acaeee9a8759
Publikováno v:
Upsala Journal of Medical Sciences, Vol 124, Iss 1, Pp 37-41 (2019)
The pragmatic clinical trial addresses scientific questions in a setting close to routine clinical practice and sometimes using routinely collected data. From a regulatory perspective, when evaluating a new medicine before approving marketing authori
Externí odkaz:
https://doaj.org/article/0fa1f35e1c714c499ced75bd52ff4433
Autor:
Alexander R Giaquinto, Alberto Grignolo, Lawrence Liberti, John C W Lim, Tomas Salmonson, Fernand Sauer, Henrietta Ukwu
Publikováno v:
PLoS Medicine, Vol 17, Iss 8, p e1003092 (2020)
Alexander Giaquinto and co-authors discuss the East African Community's Medicines Regulatory Harmonization initiative.
Externí odkaz:
https://doaj.org/article/6aea43aca56d457aade0303ba75b9eff
Autor:
Yang Yu, kyriaki Tzogani, Tomas Salmonson, Christian Gisselbrecht, Francesco Pignatti, Didier Meulendijks, Carla Herberts, Paula Hennik, Remy Verheijen, Torunn Wangen, Gro Dahlseng Håkonsen, Torny Kaasboll, Marianne Dalhus, Bjorg Bolstad
Publikováno v:
ESMO Open, Vol 4, Iss 6 (2019)
On 18 September 2017, a marketing authorisation valid through the European Union (EU) was issued for midostaurin in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy and for patients i
Externí odkaz:
https://doaj.org/article/4ca5e08d64734ec4aef2f64b34b02f26
Publikováno v:
Upsala Journal of Medical Sciences, Vol 124, Iss 1, Pp 37-41 (2019)
Upsala Journal of Medical Sciences
Upsala Journal of Medical Sciences
The pragmatic clinical trial addresses scientific questions in a setting close to routine clinical practice and sometimes using routinely collected data. From a regulatory perspective, when evaluating a new medicine before approving marketing authori
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::96a4df7325c1d3c72b36c327d8e76bf3
https://doaj.org/article/0fa1f35e1c714c499ced75bd52ff4433
https://doaj.org/article/0fa1f35e1c714c499ced75bd52ff4433
Autor:
John Joseph Borg, Jean-Louis Robert, George Wade, George Aislaitner, Michal Pirozynski, Eric Abadie, Tomas Salmonson, Patricia Vella Bonanno
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 12, Iss 2 (2009)
ABSTRACT – Purpose. The aim of this study was to identify common trends in the deficiencies identified in the quality part of the dossier during the evaluation of marketing authorisation applications for medicinal products for human use submitted t
Externí odkaz:
https://doaj.org/article/fc969a00cabe4c4a8b1c439ba830c36b
Autor:
Jonas Bergh, Paula van Hennik, Tomas Salmonson, Jan Sjöberg, Edward Laane, Kyriaki Tzogani, Christian Gisselbrecht, Pieter de Graeff, Francesco Pignatti, Ita Walsh, Annika Folin, Heinz Ludwig
Publikováno v:
The Oncologist
This article summarizes the scientific review of panobinostat that led to regulatory approval in the European Union.
On August 28, 2015, a marketing authorization valid through the European Union was issued for panobinostat, in combination with
On August 28, 2015, a marketing authorization valid through the European Union was issued for panobinostat, in combination with
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3af7cbd290c7b1aa5d99a60e046ec8d9
https://doi.org/10.1634/theoncologist.2017-0301
https://doi.org/10.1634/theoncologist.2017-0301
Autor:
Francesca Wirth, John Joseph Borg, Tomas Salmonson, Sol Ruiz, Mark Cilia, Peter Richardson, Anthony Serracino-Inglott
Publikováno v:
AAPS PharmSciTech. 19:489-511
The aim of this study was to identify trends in deficiencies raised during the EU evaluation of the quality part of dossiers for marketing authorisation applications of biosimilar medicinal products. All adopted day 120 list of questions on the quali
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f9044d8feecd13e1d035bb1bfee8f3d3
https://doi.org/10.1208/s12249-017-0892-0
https://doi.org/10.1208/s12249-017-0892-0