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Position statement on radiopharmaceutical production for clinical trials.
Bormans, G; Buck, A; Chiti, A; Cooper, M; Croasdale, J; Desruet, M; Kumar, V; Liu, Y; Penuelas, I; Rossetti, C; Schiavo, R; Schwarz, S W; Windhorst, A D.
Afiliación
  • Bormans G; 1Radiopharmaceutical Research KU Leuven, Leuven, Belgium.
  • Buck A; 2University of Wurzburg, Würzburg, Germany.
  • Chiti A; Humanitas University and Humanitas Research Hospital, Milan, Italy.
  • Cooper M; 4Royal Liverpool University Hospital, Liverpool, UK.
  • Croasdale J; 5Sandwell & West Birmingham Hospitals NHS Trust, Birmingham, UK.
  • Desruet M; Hospital Grenoble-Alpes, La Tronche, France.
  • Kumar V; 7Sydney Medical School, Sydney University, Camperdown, Australia.
  • Liu Y; 8European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
  • Penuelas I; ClínicaUniversidad de Navarra, Pamplona, Spain.
  • Rossetti C; 10Ospedale Niguarda, Milan, Italy.
  • Schiavo R; 11Ospedale Belcolle, Viterbo, Italy.
  • Schwarz SW; 12Washington University School of Medicine, St. Louis, MO USA.
  • Windhorst AD; 13VU University Medical Center, Amsterdam, The Netherlands.
EJNMMI Radiopharm Chem ; 2(1): 12, 2017.
Article en En | MEDLINE | ID: mdl-29503853
The EU regulation 536/2014 aims to facilitate the experimental use of diagnostic radiopharmaceuticals in particular for GMP requirements and needs to be applied in EU countries. As definitely clarified by this survey, the application is still far from being completed due to national restrictions that are conflicting with the content of the above EU regulation. Although the nuclear medicine centers are obliged to be compliant with national regulatory, national authorities have to be required to work towards full application of the regulation. On the other hand, an update of 536/2014 that includes therapeutic radiopharmaceuticals would also be beneficial to a rational and safe advance of nuclear medicine.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: EJNMMI Radiopharm Chem Año: 2017 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Reino Unido
Texto completo
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Imprimir
XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: EJNMMI Radiopharm Chem Año: 2017 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Reino Unido