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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...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Cambridge University Press
2021
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| Materias: | |
| 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 |