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後発医薬品会社における個別症例安全性報告の因果関係評価基準
http://hdl.handle.net/2297/18244
http://hdl.handle.net/2297/18244aadacc5a-5ae4-44be-908d-2a94dced40b9
| 名前 / ファイル | ライセンス | アクション |
|---|---|---|
PH-PR-MIYAMOTO-K-173.pdf (1.1 MB)
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| Item type | 学術雑誌論文 / Journal Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2017-10-04 | |||||
| タイトル | ||||||
| タイトル | 後発医薬品会社における個別症例安全性報告の因果関係評価基準 | |||||
| タイトル | ||||||
| タイトル | Criteria for causality assessment of individual case safety report used in pharmaceutical manufacturers of generic drugs | |||||
| 言語 | en | |||||
| 言語 | ||||||
| 言語 | jpn | |||||
| 資源タイプ | ||||||
| 資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
| 資源タイプ | journal article | |||||
| 著者 |
高月, 公博
× 高月, 公博× 古川, 裕之× 宮本, 謙一 |
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| 書誌情報 |
臨床薬理 = Japanese journal of clinical pharmacology 巻 39, 号 5, p. 173-179, 発行日 2008-09-01 |
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| ISSN | ||||||
| 収録物識別子タイプ | ISSN | |||||
| 収録物識別子 | 0388-1601 | |||||
| NCID | ||||||
| 収録物識別子タイプ | NCID | |||||
| 収録物識別子 | AN0025404X | |||||
| DOI | ||||||
| 関連タイプ | isIdenticalTo | |||||
| 識別子タイプ | DOI | |||||
| 関連識別子 | 10.3999/jscpt.39.173 | |||||
| 出版者 | ||||||
| 出版者 | 日本臨床薬理学会 = The Japanese Society of Clinical Pharmacology and Therapeutics | |||||
| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | The purpose of this study was to determine the items necessary for causality assessment in order to improve the usefulness of the individual case safety report (ICSR) from medical institutions as adverse drug reaction (ADR) information. Thus, we evaluated the standard items for causality assessment by surveying the items used in pharmaceutical manufacturers of generic drugs. The number of respondents was 35, which was 89.7% of the member companies of Japan Generic Pharmaceutical Manufacturers Association. The use of algorithms for causality assessment, terms for causal relation, and criteria for assessing whether or not ADR were varied among the companies. These findings were similar to the previous results in a survey of pharmaceutical companies of original drug. The variety of assessment criteria is inconvenient for reporters to judge and also lowers the validity of judgment. Additionally, it will be inappropriate to assess ADR information all together. And these variations may cause wide differences in the frequency measurement of ADR. Therefore, it is crucial to immediately derive consensus on international assessment criteria for causality assessment. | |||||
| 権利 | ||||||
| 権利情報 | Copyright (c) 2009 日本臨床薬理学会 | |||||
| 著者版フラグ | ||||||
| 出版タイプ | VoR | |||||
| 出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
| 関連URI | ||||||
| 識別子タイプ | URI | |||||
| 関連識別子 | http://www.jscpt.jp/ | |||||
| 関連URI | ||||||
| 識別子タイプ | URI | |||||
| 関連識別子 | http://www.jstage.jst.go.jp/article/jscpt/39/5/39_173/_article/-char/ja | |||||
