EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations

AIMS: The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) produce guidelines for the design of pivotal psychiatric drug trials used in new drug applications. It is unknown who are involved in the guideline development and what specific trial design recommendations they...

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Detalles Bibliográficos
Autores principales: Boesen, Kim, Gøtzsche, Peter C., Ioannidis, John P. A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2021
Materias:
Original Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8157504/
https://www.ncbi.nlm.nih.gov/pubmed/33926608
http://dx.doi.org/10.1017/S2045796021000147

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8157504/
https://www.ncbi.nlm.nih.gov/pubmed/33926608
http://dx.doi.org/10.1017/S2045796021000147

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