{"created":"2023-05-15T14:56:59.749178+00:00","id":77345,"links":{},"metadata":{"_buckets":{"deposit":"9e0fefb2-ddc9-4f67-937a-fde8b1cb9b68"},"_deposit":{"created_by":1,"id":"77345","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"77345"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00077345","sets":["10:28"]},"author_link":["800194","800196","800192","800201","800195","800191","800204","800199","800203","800197","800198","800193","800202","800200"],"item_10005_date_7":{"attribute_name":"発表年月日","attribute_value_mlt":[{"subitem_date_issued_datetime":"2019-11-01","subitem_date_issued_type":"Issued"}]},"item_10005_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"【目的】[64Cu]Cu-ATSMは脳腫瘍の治療に効果が期待されている日本発の治療用放射性薬剤である。今回、将来の承認申請を見据えた本薬剤の規格値の設定および品質検査法の確立を行い、治験薬の規格に採用したので実績を報告する。【方法】治療用[64Cu]Cu-ATSM注射液の品質検査項目として、製造ごとに液量、放射能、性状、pH、放射性異核種、放射化学的異物、[64Cu]Cu-ATSM特異性、エンドトキシン、無菌試験、1年に1回以上、アセトンとジメチルスルホキシドの濃度測定を行うこととした。【結果】Radio-TLCによる放射化学的異物の測定においては、放射能検出器の定量限界と定量上限から、10%の放射化学的異物を定量可能な検体の放射能濃度を300～500 kBq/μLに設定し、希釈法による検査法を確立し、分析法バリデーションを行った上で採用した。また、他の検査も日本薬局方に準拠した方法で行うことで将来の承認申請に対応できる治療用[64Cu]Cu-ATSM注射液の品質検査法及び規格値を確立できた。さらに、本規格試験を3ロット試験製造および治験薬に適用し、すべての製造ロットについて適合した。","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59回日本核医学会学術総会","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":"橋本, 裕輝"}],"nameIdentifiers":[{"nameIdentifier":"800191","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"破入, 正行"}],"nameIdentifiers":[{"nameIdentifier":"800192","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"大久保, 崇之"}],"nameIdentifiers":[{"nameIdentifier":"800193","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"河村, 和紀"}],"nameIdentifiers":[{"nameIdentifier":"800194","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"吉井, 幸恵"}],"nameIdentifiers":[{"nameIdentifier":"800195","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"脇, 厚生"}],"nameIdentifiers":[{"nameIdentifier":"800196","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"張, 明栄"}],"nameIdentifiers":[{"nameIdentifier":"800197","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Hashimoto, Hiroki","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"800198","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Hanyu, Masayuki","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"800199","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Ohkubo, Takayuki","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"800200","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Kawamura, Kazunori","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"800201","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Yoshii, Yukie","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"800202","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Waki, Atsuo","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"800203","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Ming-Rong, Zhang","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"800204","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":"承認申請を見据えた[64Cu]Cu-ATSM注射液の品質検査法の設定","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"承認申請を見据えた[64Cu]Cu-ATSM注射液の品質検査法の設定"}]},"item_type_id":"10005","owner":"1","path":["28"],"pubdate":{"attribute_name":"公開日","attribute_value":"2019-11-07"},"publish_date":"2019-11-07","publish_status":"0","recid":"77345","relation_version_is_last":true,"title":["承認申請を見据えた[64Cu]Cu-ATSM注射液の品質検査法の設定"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T23:48:28.361577+00:00"}