Cargando…

Evaluation of quantitative signal detection in EudraVigilance for orphan drugs: possible risk of false negatives

Different strategies have been studied to allow a better characterization of the safety profile of orphan drugs soon after their approval. At the end of the development phases only few data are available because of the small number of subjects exposed to an orphan medicine for the treatment of rare...

Descripción completa

Detalles Bibliográficos
Autores principales: Sardella, Marco, Lungu, Calin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6804351/
https://www.ncbi.nlm.nih.gov/pubmed/31673326
http://dx.doi.org/10.1177/2042098619882819