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Regulating phage therapy: The biological master file concept could help to overcome regulatory challenge of personalized medicines

The clinical use of bacteriophages to treat bacterial infections faces regulatory difficulties in the EU. The ‘Biological Master File’ concept could overcome these hurdles for phage therapy as well as other personalized medicines. [Image: see text]

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Detalhes bibliográficos
Publicado no:EMBO Rep
Autor principal: Fauconnier, Alan
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2017
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5286392/
https://ncbi.nlm.nih.gov/pubmed/28082313
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.15252/embr.201643250
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