Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008–2012)

The present study aimed at systematically reviewing the role and extent of patient-reported outcomes (PROs) usage within the package of scientific evidence considered for marketing authorization (MA). All regulatory information published by the European Medicines Agency (EMA) for products authorized...

Descripción completa

Detalles Bibliográficos
Autores principales: Bansal, Dipika, Bhagat, Anil, Schifano, Fabrizio, Gudala, Kapil
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Atlantis Press 2015
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7320500/
https://www.ncbi.nlm.nih.gov/pubmed/26031612
http://dx.doi.org/10.1016/j.jegh.2015.04.006

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7320500/
https://www.ncbi.nlm.nih.gov/pubmed/26031612
http://dx.doi.org/10.1016/j.jegh.2015.04.006

Ejemplares similares