Cargando…

Authoring a periodic adverse drug experience report…here's what you need to know!

Aggregate reporting involves preparation and submission of safety reports for a given medicinal product to worldwide regulatory agencies and constitutes an essential part of safety monitoring of a medicinal product. There are specific aggregate safety reports required for a molecule in development c...

Descripción completa

Detalles Bibliográficos
Autores principales: Kulkarni, Tejashree N., Kulkarni, Niranjan G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463498/
https://www.ncbi.nlm.nih.gov/pubmed/31008077
http://dx.doi.org/10.4103/picr.PICR_126_18