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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...

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Detalles Bibliográficos
Autores principales: Mordenti, Marina, Boarini, Manila, D’Alessandro, Fabio, Pedrini, Elena, Locatelli, Manuela, Sangiorgi, Luca
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
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