{"created":"2023-05-15T14:42:10.095049+00:00","id":57803,"links":{},"metadata":{"_buckets":{"deposit":"660357f9-b134-4567-9116-f4d5eb412c37"},"_deposit":{"created_by":1,"id":"57803","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"57803"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00057803","sets":["11"]},"author_link":["581854","581853"],"item_10004_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2010-10","bibliographicIssueDateType":"Issued"},"bibliographicPageEnd":"195","bibliographicPageStart":"188","bibliographic_titles":[{"bibliographic_title":"創薬技術の革新 : マイクロドーズからPET分子イメージングへの新展開 (遺伝子医学MOOK ; 別冊)"}]}]},"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)、PET分子イメージングが医薬品臨床開発の新たな手法として注目される。欧米諸国ではこれらを活用した研究推進の政策立案と規制整備が進められ、日本もこれを追いかける形である。2008年6月にはIHC(日米EU医薬品規制調和国際会議)でMD試験を含む探索的臨床試験の規制調和が行われた。本稿では、日米EU三極における、MD試験とPET分子イメージングの規制・政策の動向を概観する。","subitem_description_type":"Abstract"}]},"item_10004_publisher_8":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"メディカルドゥ"}]},"item_10004_relation_10":{"attribute_name":"ISBN","attribute_value_mlt":[{"subitem_relation_type_id":{"subitem_relation_type_id_text":"978-4-9441-5780","subitem_relation_type_select":"ISBN"}}]},"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":"581853","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"栗原 千絵子","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"581854","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":"マイクロドーズ・PET分子イメージングに関する政策・規制の世界的動向","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"マイクロドーズ・PET分子イメージングに関する政策・規制の世界的動向"}]},"item_type_id":"10004","owner":"1","path":["11"],"pubdate":{"attribute_name":"公開日","attribute_value":"2010-11-18"},"publish_date":"2010-11-18","publish_status":"0","recid":"57803","relation_version_is_last":true,"title":["マイクロドーズ・PET分子イメージングに関する政策・規制の世界的動向"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T22:23:04.196171+00:00"}