{"created":"2023-05-15T14:46:19.226375+00:00","id":63586,"links":{},"metadata":{"_buckets":{"deposit":"5f01e127-a36d-47f7-a13e-edcd02f4e6b5"},"_deposit":{"created_by":1,"id":"63586","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"63586"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00063586","sets":["10:29"]},"author_link":["627562","627561","627559","627564","627560","627566","627563","627565"],"item_10005_date_7":{"attribute_name":"発表年月日","attribute_value_mlt":[{"subitem_date_issued_datetime":"2009-10-03","subitem_date_issued_type":"Issued"}]},"item_10005_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"背景：医薬品開発研究の過程において候補化合物を放射性同位元素で標識し化合物の\n薬物動態を予測する臨床試験が必要とされるが日本国内に実施環境が十分整備されて\nいない。目的：実施環境整備に必要な一要素としての被ばく線量評価に関する審査委\n員会のあるべき方向性と重要な着眼点を明らかにする。方法：医薬品開発支援機構に\n設置された放射線被ばく評価委員会における手順書作成、実際の審査過程と審査結果\nの検討、これらについての核医学専門家を含む関係者からの聴き取り調査、国内外の\n審査体制の文献調査。結果：審査実施の際、臨床試験実施計画書、被験者用説明文書\nにおいて、外部委員会の核医学専門家より線量評価の記述方法につき重要な指摘がな\nされるとともに、本審査方式を国内に定着させる手順、あるべき方向性が明確になっ\nた。結論：臨床試験の被験者の放射線被ばく線量の正当性の評価においては、核医学\nの専門家を含む外部委員会における審査が、規制上の要件ではないにも関わらず有用\nであり、医薬品開発研究の推進に寄与すると考える。","subitem_description_type":"Abstract"}]},"item_10005_description_6":{"attribute_name":"会議概要（会議名, 開催地, 会期, 主催者等）","attribute_value_mlt":[{"subitem_description":"第４９回日本核医学界学術総会","subitem_description_type":"Other"}]},"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":"627559","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"福島, 芳子"}],"nameIdentifiers":[{"nameIdentifier":"627560","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"稲野, 彰洋"}],"nameIdentifiers":[{"nameIdentifier":"627561","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"伊藤, 久裕"}],"nameIdentifiers":[{"nameIdentifier":"627562","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"池田, 敏彦"}],"nameIdentifiers":[{"nameIdentifier":"627563","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"杉山, 雄一"}],"nameIdentifiers":[{"nameIdentifier":"627564","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"栗原 千絵子","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"627565","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"福島 芳子","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"627566","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":"conference object","resourceuri":"http://purl.org/coar/resource_type/c_c94f"}]},"item_title":"１４C標識薬剤投与試験における被ばく線量評価のあり方-外部審査実施例からの検討","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"１４C標識薬剤投与試験における被ばく線量評価のあり方-外部審査実施例からの検討"}]},"item_type_id":"10005","owner":"1","path":["29"],"pubdate":{"attribute_name":"公開日","attribute_value":"2009-10-05"},"publish_date":"2009-10-05","publish_status":"0","recid":"63586","relation_version_is_last":true,"title":["１４C標識薬剤投与試験における被ばく線量評価のあり方-外部審査実施例からの検討"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T21:21:17.317396+00:00"}