Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases

BACKGROUND: The use of a statistical approach to analyze cumulative adverse event (AE) reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection). Further, differences in regulations, social issues, and health care systems can c...

Descripción completa

Detalles Bibliográficos
Autores principales: Nomura, Kaori, Takahashi, Kunihiko, Hinomura, Yasushi, Kawaguchi, Genta, Matsushita, Yasuyuki, Marui, Hiroko, Anzai, Tatsuhiko, Hashiguchi, Masayuki, Mochizuki, Mayumi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2015
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4472069/
https://www.ncbi.nlm.nih.gov/pubmed/26109846
http://dx.doi.org/10.2147/DDDT.S81998

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4472069/
https://www.ncbi.nlm.nih.gov/pubmed/26109846
http://dx.doi.org/10.2147/DDDT.S81998

Ejemplares similares