Significance of data mining in routine signal detection: Analysis based on the safety signals identified by the FDA-Reference-Cited by-同舟云学术

Significance of data mining in routine signal detection: Analysis based on the safety signals identified by the FDA

Published:2018-10-15 Issue:12 Volume:27 Page:1402-1408
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Fukazawa Chisato¹²^ORCID,Hinomura Yasushi²,Kaneko Masayuki¹,Narukawa Mamoru¹

Affiliation:

1. Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences; Kitasato University; Tokyo Japan

2. Japan Pharmaceutical Information Center; Tokyo Japan

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.4672/fullpdf

Reference25 articles.

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2. EMA Guideline on good pharmacovigilance practices 2012

3. Manual of Policies & Procedures (CDER) 6700 9 FDA posting of potential signals of serious risks identified by the adverse event reporting system https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM248882.pdf

4. Use of triage strategies in the WHO signal-detection process;Lindquist;Drug Saf,2007

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