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Remodeling an existing rare disease registry to be used in regulatory context: Lessons learned and recommendations
Disease registries have been used as an interesting source of real-world data for supporting regulatory decision-making. In fact, drug studies based on registries cover pre-approval investigation, registry randomized clinical trials, and post-authorization studies. This opportunity has been investig...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9537464/ https://www.ncbi.nlm.nih.gov/pubmed/36210847 http://dx.doi.org/10.3389/fphar.2022.966081 |