2．Consideration of Signal Management Process
Author:
Affiliation:
1. Pharmaceutical and Medical Device Regulatory Science Society of Japan
2. Janssen Pharmaceutical K.K., Japan
Publisher
Japanese Society for Pharmacoepidemiology
Subject
General Medicine
Link
https://www.jstage.jst.go.jp/article/jjpe/25/1/25_25.28/_pdf
Reference9 articles.
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2. 4) CIOMS Ⅷ Working Group. Practical aspects of signal detection in pharmacovigilance. CIOMS, 2010.
3. 7) Pacurariu AC, Coloma PM, Gross-Martirosyan L, Sturkenboom MC, Straus SM. Decision making in drug safety -a literature review of criteria used to prioritize newly detected safety issues. Pharmacoepidemiol Drug Saf 2017； 26 (3) ： 327-34.
4. 8) Caster O, Juhlin K, Watson S, Norén GN. Improved statistical signal detection in pharmacovigilance by combining multiple strength-of-evidence aspects in vigiRank. Drug Saf 2014； 37 (8) ： 617-28.
5. 9) Seabroke S, Wise L, Waller P. Development of a Novel Regulatory Pharmacovigilance Prioritisation System ： An Evaluation of Its Performance at the UK Medicines and Healthcare products Regulatory Agency. Drug Saf 2013； 36 (10) ： 1025-32.
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