{"created":"2023-05-15T14:42:14.634447+00:00","id":57904,"links":{},"metadata":{"_buckets":{"deposit":"5b4abb3a-0e59-47ac-a08e-c58edef58e4d"},"_deposit":{"created_by":1,"id":"57904","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"57904"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00057904","sets":["11"]},"author_link":["582399","582400"],"item_10004_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2011-01","bibliographicIssueDateType":"Issued"},"bibliographicPageEnd":"510","bibliographicPageStart":"503","bibliographic_titles":[{"bibliographic_title":"Advanced Drug Delivery Reviews"}]}]},"item_10004_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"A 'microdose clinical trial' (microdosing) is one kind of early phase exploratory clinical trial, administering\nthe compound at doses estimated to have no pharmacological or toxicological effects, aimed at screening\ncandidates for further clinical development. This article's objective is to clarify the ethical, legal, and social\nimplications (ELSI) of such an exploratory minimum-risk human trial. The definition and non-clinical study\nrequirements for microdosing have been harmonized among the European Union (EU), United States (US),\nand Japan. Being conducted according to these regulations, microdosing seems to be ethically well justified in\nterms of respect for persons, beneficence, justice, human dignity, and animal welfare. Three big projects have\nbeen demonstrating the predictability of therapeutic dose pharmacokinetics from microdosing. The article\noffers suggestions as how microdosing can become a more useful and socially accepted strategy.","subitem_description_type":"Abstract"}]},"item_10004_source_id_9":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"0169-409X","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":"Kurihara, Chieko"}],"nameIdentifiers":[{"nameIdentifier":"582399","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"栗原 千絵子","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"582400","nameIdentifierScheme":"WEKO"}]}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"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":"Ethical, legal, and social implications (ELSI) of microdose clinical trials","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"Ethical, legal, and social implications (ELSI) of microdose clinical trials"}]},"item_type_id":"10004","owner":"1","path":["11"],"pubdate":{"attribute_name":"公開日","attribute_value":"2011-06-14"},"publish_date":"2011-06-14","publish_status":"0","recid":"57904","relation_version_is_last":true,"title":["Ethical, legal, and social implications (ELSI) of microdose clinical trials"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T22:21:56.266237+00:00"}