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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...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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John Wiley & Sons, Inc.
2020
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| 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 |