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<b>5. JADER from Pharmacovigilance Point of View</b>
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- MAEDA Rei
- Surveillance & Epidemiology, Global Patient Safety Japan, Eli Lilly Japan K.K.
Bibliographic Information
- Other Title
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- <b>5. 医薬品安全性監視の観点から JADER について考える</b>
- 5. JADER from Pharmacovigilance Point of View
- JADER from Pharmacovigilance Point of View
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Description
From pharmacovigilance point of view in Japan, individual case safety reports from industries are important evidence when authorities make decision regarding safety issues, e.g., package insert change. On the other hand, aggregate analysis is not majority due to less infrastructure of available large database than EU/US. Japanese Adverse Drug Event Report database (JADER), which ICSRs have been cumulated, has been tried to use for aggregate analysis. It is not appropriate to use for the purpose of signal management or for primarily deriving safety measures, considering that its source does not cover all the safety information but “spontaneously reported serious adverse reaction”. However, it would be worthwhile to use JADER as a virtual tool to become able to utilize coming large EHR DB and National Claim Database which the authorities have been constructing to be available within few years.
Journal
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- Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku
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Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku 19 (1), 51-56, 2014
Japanese Society for Pharmacoepidemiology
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Keywords
Details 詳細情報について
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- CRID
- 1390282679460988928
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- NII Article ID
- 130004679418
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- ISSN
- 1882790X
- 13420445
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- Text Lang
- ja
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- Data Source
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- JaLC
- Crossref
- CiNii Articles
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- Abstract License Flag
- Disallowed