WEKO3
インデックスリンク
アイテム
{"_buckets": {"deposit": "5243af48-62f1-4363-acd0-19fc70cd807c"}, "_deposit": {"created_by": 3, "id": "26990", "owners": [3], "pid": {"revision_id": 0, "type": "depid", "value": "26990"}, "status": "published"}, "_oai": {"id": "oai:kanazawa-u.repo.nii.ac.jp:00026990", "sets": ["1763"]}, "author_link": ["22059", "706", "45726"], "item_4_biblio_info_8": {"attribute_name": "書誌情報", "attribute_value_mlt": [{"bibliographicIssueDates": {"bibliographicIssueDate": "2008-09-10", "bibliographicIssueDateType": "Issued"}, "bibliographicIssueNumber": "9", "bibliographicPageEnd": "846", "bibliographicPageStart": "838", "bibliographicVolumeNumber": "34", "bibliographic_titles": [{"bibliographic_title": "医療薬学"}]}]}, "item_4_description_21": {"attribute_name": "抄録", "attribute_value_mlt": [{"subitem_description": "The purpose of this study was to clarify the causality assessment information items necessary to improve the usefulness of individual case safety reports (ICSRs) from medical facilities as adverse drug reaction (ADR) information. To do this, we investigated standard causality assessment items used by pharmaceutical companies. The number of the companies responding was 76, 93.8% of all Japan Pharmaceutical Manufacturers Association (JPMA) member companies. We found that the use of algorithms for causality assessment, the grades and expressions used to describe causality, and criteria for determining whether reactions were ADRs or not varied among the companies as well as their divisions (whether they conducted clinical trials or post-marketing surveillance). Having such a variety of assessment criteria is inconvenient for the reporters who have to judge it and also lowers the validity of judgments. It also hampers the overall assessment of ADR information and may cause great differences in ADR frequencies. We therefore feel that it is desirable to agree on international criteria for causality assessment as soon as possible.", "subitem_description_type": "Abstract"}]}, "item_4_publisher_17": {"attribute_name": "出版者", "attribute_value_mlt": [{"subitem_publisher": "日本医療薬学会 = Japanese Society of Phamaceutical Health care and Sciences"}]}, "item_4_relation_12": {"attribute_name": "DOI", "attribute_value_mlt": [{"subitem_relation_type": "isIdenticalTo", "subitem_relation_type_id": {"subitem_relation_type_id_text": "10.5649/jjphcs.34.838", "subitem_relation_type_select": "DOI"}}]}, "item_4_relation_28": {"attribute_name": "関連URI", "attribute_value_mlt": [{"subitem_relation_type_id": {"subitem_relation_type_id_text": "http://www.jsphcs.jp/", "subitem_relation_type_select": "URI"}}, {"subitem_relation_type_id": {"subitem_relation_type_id_text": "http://ci.nii.ac.jp/naid/110006946024", "subitem_relation_type_select": "URI"}}, {"subitem_relation_type_id": {"subitem_relation_type_id_text": "https://japanlinkcenter.org/JST.JSTAGE/jjphcs/34.838", "subitem_relation_type_select": "URI"}}]}, "item_4_rights_23": {"attribute_name": "権利", "attribute_value_mlt": [{"subitem_rights": "Copyright (c) 2010 日本医療薬学会"}]}, "item_4_source_id_11": {"attribute_name": "NCID", "attribute_value_mlt": [{"subitem_source_identifier": "AA11527197", "subitem_source_identifier_type": "NCID"}]}, "item_4_source_id_9": {"attribute_name": "ISSN", "attribute_value_mlt": [{"subitem_source_identifier": "1346-342X", "subitem_source_identifier_type": "ISSN"}]}, "item_4_version_type_25": {"attribute_name": "著者版フラグ", "attribute_value_mlt": [{"subitem_version_resource": "http://purl.org/coar/version/c_970fb48d4fbd8a85", "subitem_version_type": "VoR"}]}, "item_creator": {"attribute_name": "著者", "attribute_type": "creator", "attribute_value_mlt": [{"creatorNames": [{"creatorName": "高月, 公博"}], "nameIdentifiers": [{"nameIdentifier": "45726", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "古川, 裕之"}], "nameIdentifiers": [{"nameIdentifier": "706", "nameIdentifierScheme": "WEKO"}, {"nameIdentifier": "50361986", "nameIdentifierScheme": "研究者番号", "nameIdentifierURI": "https://nrid.nii.ac.jp/nrid/1000050361986"}]}, {"creatorNames": [{"creatorName": "宮本, 謙一"}], "nameIdentifiers": [{"nameIdentifier": "22059", "nameIdentifierScheme": "WEKO"}, {"nameIdentifier": "30100514", "nameIdentifierScheme": "研究者番号", "nameIdentifierURI": "https://nrid.nii.ac.jp/nrid/1000030100514"}]}]}, "item_files": {"attribute_name": "ファイル情報", "attribute_type": "file", "attribute_value_mlt": [{"accessrole": "open_date", "date": [{"dateType": "Available", "dateValue": "2017-10-05"}], "displaytype": "detail", "download_preview_message": "", "file_order": 0, "filename": "HO-PR-MIYAMOTO-K-838.pdf", "filesize": [{"value": "132.3 kB"}], "format": "application/pdf", "future_date_message": "", "is_thumbnail": false, "licensetype": "license_free", "mimetype": "application/pdf", "size": 132300.0, "url": {"label": "HO-PR-MIYAMOTO-K-838.pdf", "url": "https://kanazawa-u.repo.nii.ac.jp/record/26990/files/HO-PR-MIYAMOTO-K-838.pdf"}, "version_id": "8a37a907-d595-497b-ab32-026f359365c0"}]}, "item_language": {"attribute_name": "言語", "attribute_value_mlt": [{"subitem_language": "jpn"}]}, "item_resource_type": {"attribute_name": "資源タイプ", "attribute_value_mlt": [{"resourcetype": "journal article", "resourceuri": "http://purl.org/coar/resource_type/c_6501"}]}, "item_title": "個別症例安全性報告の因果関係評価基準の問題点", "item_titles": {"attribute_name": "タイトル", "attribute_value_mlt": [{"subitem_title": "個別症例安全性報告の因果関係評価基準の問題点"}, {"subitem_title": "Problems with Causality Assessment Criteria for Individual Case Safety Reports", "subitem_title_language": "en"}]}, "item_type_id": "4", "owner": "3", "path": ["1763"], "permalink_uri": "http://hdl.handle.net/2297/28424", "pubdate": {"attribute_name": "公開日", "attribute_value": "2017-10-05"}, "publish_date": "2017-10-05", "publish_status": "0", "recid": "26990", "relation": {}, "relation_version_is_last": true, "title": ["個別症例安全性報告の因果関係評価基準の問題点"], "weko_shared_id": -1}
個別症例安全性報告の因果関係評価基準の問題点
http://hdl.handle.net/2297/28424
http://hdl.handle.net/2297/28424dc9f39e1-d5d8-45e3-9f6a-4afc70e540ee
名前 / ファイル | ライセンス | アクション |
---|---|---|
HO-PR-MIYAMOTO-K-838.pdf (132.3 kB)
|
|
Item type | 学術雑誌論文 / Journal Article(1) | |||||
---|---|---|---|---|---|---|
公開日 | 2017-10-05 | |||||
タイトル | ||||||
タイトル | 個別症例安全性報告の因果関係評価基準の問題点 | |||||
タイトル | ||||||
言語 | en | |||||
タイトル | Problems with Causality Assessment Criteria for Individual Case Safety Reports | |||||
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 |
|||||
書誌情報 |
医療薬学 巻 34, 号 9, p. 838-846, 発行日 2008-09-10 |
|||||
ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 1346-342X | |||||
NCID | ||||||
収録物識別子タイプ | NCID | |||||
収録物識別子 | AA11527197 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.5649/jjphcs.34.838 | |||||
出版者 | ||||||
出版者 | 日本医療薬学会 = Japanese Society of Phamaceutical Health care and Sciences | |||||
抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | The purpose of this study was to clarify the causality assessment information items necessary to improve the usefulness of individual case safety reports (ICSRs) from medical facilities as adverse drug reaction (ADR) information. To do this, we investigated standard causality assessment items used by pharmaceutical companies. The number of the companies responding was 76, 93.8% of all Japan Pharmaceutical Manufacturers Association (JPMA) member companies. We found that the use of algorithms for causality assessment, the grades and expressions used to describe causality, and criteria for determining whether reactions were ADRs or not varied among the companies as well as their divisions (whether they conducted clinical trials or post-marketing surveillance). Having such a variety of assessment criteria is inconvenient for the reporters who have to judge it and also lowers the validity of judgments. It also hampers the overall assessment of ADR information and may cause great differences in ADR frequencies. We therefore feel that it is desirable to agree on international criteria for causality assessment as soon as possible. | |||||
権利 | ||||||
権利情報 | Copyright (c) 2010 日本医療薬学会 | |||||
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.jsphcs.jp/ | |||||
関連URI | ||||||
識別子タイプ | URI | |||||
関連識別子 | http://ci.nii.ac.jp/naid/110006946024 | |||||
関連URI | ||||||
識別子タイプ | URI | |||||
関連識別子 | https://japanlinkcenter.org/JST.JSTAGE/jjphcs/34.838 |