Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective

The European Medicines Agency (EMA) revises its guideline on minimizing risk in first‐in‐human trials to reflect changing practice and in light of a recent tragic incident.

Detalles Bibliográficos
Autores principales: Ponzano, Stefano, Blake, Kevin, Bonelli, Milton, Enzmann, Harald
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Perspectives
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5873368/
https://www.ncbi.nlm.nih.gov/pubmed/29105746
http://dx.doi.org/10.1002/cpt.899

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5873368/
https://www.ncbi.nlm.nih.gov/pubmed/29105746
http://dx.doi.org/10.1002/cpt.899

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