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Assessing strength of evidence for regulatory decision making in licensing: What proof do we need for observational studies of effectiveness?

Before a medicine can be recommended for a marketing authorization research must be provided to regulators that convincingly supports the benefit‐risk of the product in the claimed indication. The established criteria for such research are usually expressed in terms of evidence from randomized contr...

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Detalles Bibliográficos
Autores principales: Slattery, Jim, Kurz, Xavier
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7687174/
https://www.ncbi.nlm.nih.gov/pubmed/32301230
http://dx.doi.org/10.1002/pds.5005