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...

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Detalhes bibliográficos
Publicado no:Drug Des Devel Ther
Main Authors: Nomura, Kaori, Takahashi, Kunihiko, Hinomura, Yasushi, Kawaguchi, Genta, Matsushita, Yasuyuki, Marui, Hiroko, Anzai, Tatsuhiko, Hashiguchi, Masayuki, Mochizuki, Mayumi
Formato: Artigo
Idioma:Inglês
Publicado em: Dove Medical Press 2015
Assuntos:
Original Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4472069/
https://ncbi.nlm.nih.gov/pubmed/26109846
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.2147/DDDT.S81998
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