Dose‐Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis

In the development process for new drugs, dose‐finding studies are of major importance. Absence of these studies may lead to failed phase 3 trials and delayed marketing authorization. In our study we investigated to what extent dose‐finding studies are performed in the case of orphan drugs for metab...

Descripción completa

Detalles Bibliográficos
Autores principales: Schuller, Yvonne, Gispen‐de Wied, Christine, Hollak, Carla E. M., Leufkens, Hubertus G. M., Stoyanova‐Beninska, Violeta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Orphan Drugs
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6585723/
https://www.ncbi.nlm.nih.gov/pubmed/30192386
http://dx.doi.org/10.1002/jcph.1304

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6585723/
https://www.ncbi.nlm.nih.gov/pubmed/30192386
http://dx.doi.org/10.1002/jcph.1304

Ejemplares similares