{"created":"2023-05-15T14:42:22.219395+00:00","id":58075,"links":{},"metadata":{"_buckets":{"deposit":"2da84c91-9109-4242-90a8-c2c0af149653"},"_deposit":{"created_by":1,"id":"58075","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"58075"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00058075","sets":["11"]},"author_link":["583093","583092"],"item_10004_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2012-04","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"4月","bibliographicPageEnd":"7","bibliographicPageStart":"2","bibliographicVolumeNumber":"696","bibliographic_titles":[{"bibliographic_title":"Isotope News"}]}]},"item_10004_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"「マイクロドーズ臨床試験（ＭＤ試験）」をめぐる議論は、「基準づくり」「（日本国内での）実施可能性」「線形性（マイクロドーズ（ＭＤ）と治療用量の薬物動態の類似性）」についての議論から、「（ＭＤから治療用量の薬物動態の）予測可能性」「経済効果」「成功確率」，さらに「応用可能性」へと移行しつつある。\n　基準、国内実施可能性の課題は、国際基準が整備され、日本で既承認薬を用いたＭＤ試験を実施する大型プロジェクトが遂行され、達成された。また、欧州と日本での大型プロジェクトにより一定程度の線形性と、線形でない場合にもＭＤから治療用量の薬物動態を「予測できる」ことが論証された。「経済効果」「成功確率」については、理論上の支持論が語られているが、実証されたとは言い難い。「応用可能性」については、ＭＤ試験の手法を第?相試験に組み合わせる新たな試験デザインが活用されている。","subitem_description_type":"Abstract"}]},"item_10004_source_id_9":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"0285-5518","subitem_source_identifier_type":"ISSN"}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"metadata only access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_14cb"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"栗原, 千絵子"}],"nameIdentifiers":[{"nameIdentifier":"583092","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"栗原 千絵子","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"583093","nameIdentifierScheme":"WEKO"}]}]},"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":"article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"ﾏｲｸﾛﾄﾞｰｽﾞ臨床試験の現状と展望","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"ﾏｲｸﾛﾄﾞｰｽﾞ臨床試験の現状と展望"}]},"item_type_id":"10004","owner":"1","path":["11"],"pubdate":{"attribute_name":"公開日","attribute_value":"2012-05-18"},"publish_date":"2012-05-18","publish_status":"0","recid":"58075","relation_version_is_last":true,"title":["ﾏｲｸﾛﾄﾞｰｽﾞ臨床試験の現状と展望"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T22:20:02.776233+00:00"}