{"created":"2023-05-15T14:48:12.154659+00:00","id":66055,"links":{},"metadata":{"_buckets":{"deposit":"df556a59-5757-4200-a37a-d182297f251f"},"_deposit":{"created_by":1,"id":"66055","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"66055"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00066055","sets":["10:29"]},"author_link":["650440","650442","650448","650444","650441","650443","650446","650449","650439","650445","650447","650438"],"item_10005_date_7":{"attribute_name":"発表年月日","attribute_value_mlt":[{"subitem_date_issued_datetime":"2016-11-03","subitem_date_issued_type":"Issued"}]},"item_10005_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"放医研ではグレードA管理可能な無菌アイソレーターを導入し、[18F]FDG注射液において学会GMP準拠施設認定を受け、臨床提供を始めている。今回、我々は11C標識薬剤についても無菌アイソレーターを使用した製造を新たに開始したので報告する。無菌アイソレーターでは、11C標識薬剤合成前に過酸化水素ガス滅菌後、無菌環境下で最終ライン組み付けとリークチェックを行い、合成した11C標識薬剤をグレードA環境下に於いて導入し、ろ過滅菌、複数のバイアルへの分注、検体採取作業を行った。無菌アイソレーター内で製剤化を行うことにより、学会GMPに準拠した高品位の11C標識薬剤を提供可能とした。また、鉛遮蔽した環境で自動的に分注及びフィルター完全性試験を行えるため、作業者の被ばくを低減することができた。　しかし、無菌アイソレーターを使用すると合成終了から提供まで15分程度必要となり、半減期の短い11C標識薬剤の場合、提供被験者数に適した高い収量が必要となり、さらなる効率化を考慮する必要がある。","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56回日本核医学会学術総会に口頭発表の為","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":"武井, 誠"}],"nameIdentifiers":[{"nameIdentifier":"650438","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"河村, 和紀"}],"nameIdentifiers":[{"nameIdentifier":"650439","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"橋本, 裕輝"}],"nameIdentifiers":[{"nameIdentifier":"650440","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"狩谷, 香"}],"nameIdentifiers":[{"nameIdentifier":"650441","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"脇, 厚生"}],"nameIdentifiers":[{"nameIdentifier":"650442","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"張, 明栄"}],"nameIdentifiers":[{"nameIdentifier":"650443","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"武井 誠","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"650444","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"河村 和紀","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"650445","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"橋本 裕輝","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"650446","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"狩谷 香","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"650447","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"脇 厚生","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"650448","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"張 明栄","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"650449","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":"学会GMPに対応した無菌アイソレーターを用いた11C標識薬剤製造","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"学会GMPに対応した無菌アイソレーターを用いた11C標識薬剤製造"}]},"item_type_id":"10005","owner":"1","path":["29"],"pubdate":{"attribute_name":"公開日","attribute_value":"2016-12-22"},"publish_date":"2016-12-22","publish_status":"0","recid":"66055","relation_version_is_last":true,"title":["学会GMPに対応した無菌アイソレーターを用いた11C標識薬剤製造"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T20:53:14.756610+00:00"}