{"created":"2023-05-15T14:47:48.137297+00:00","id":65539,"links":{},"metadata":{"_buckets":{"deposit":"8afbbad2-e75b-47bc-a9b5-08569934fa05"},"_deposit":{"created_by":1,"id":"65539","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"65539"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00065539","sets":["10:29"]},"author_link":["645500","645503","645498","645499","645497","645508","645506","645509","645505","645507","645502","645501","645496","645504"],"item_10005_date_7":{"attribute_name":"発表年月日","attribute_value_mlt":[{"subitem_date_issued_datetime":"2014-11-06","subitem_date_issued_type":"Issued"}]},"item_10005_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"18F-FDG注射液は製造方法のバリデーションとして定期的に比放射能及び残留溶媒試験に適合することが求められている。放医研ではこれらの試験を外部機関から受託するに当たり、教育訓練や手順書整備、機器の校正、分析法バリデーション、試験毎にシステム適合性試験等を実施することで、試験結果の信頼性をより高いレベルで保証する体制を構築している。特に定期的な分析法バリデーションにより、HPLC-電気化学検出器によるFDGおよびClDG濃度測定法ではそれぞれ0.02ppm、0.1ppmまで、またGCによる残留溶媒濃度測定法についてもアセトニトリルなど5成分を50ppmまでを定量下限として保証している。また精度は、FDGおよびClDGについては相対標準偏差値として2%以下、残留溶媒についても5%以下と良好な再現性を示した。本演題では、上記のような放医研の受託試験の信頼性確保の方法について詳細を報告し、また受託試験結果から見た18F-FDG注射液の製造方法のバリデーションについて、留意点を述べたい。","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54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":"645496","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"狩谷, 香"}],"nameIdentifiers":[{"nameIdentifier":"645497","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"河村, 和紀"}],"nameIdentifiers":[{"nameIdentifier":"645498","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"岩隈, 佳寿子"}],"nameIdentifiers":[{"nameIdentifier":"645499","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"脇, 厚生"}],"nameIdentifiers":[{"nameIdentifier":"645500","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"藤林, 康久"}],"nameIdentifiers":[{"nameIdentifier":"645501","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"張, 明栄"}],"nameIdentifiers":[{"nameIdentifier":"645502","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"橋本 裕輝","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"645503","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"狩谷 香","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"645504","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"河村 和紀","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"645505","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"岩隈 佳寿子","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"645506","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"脇 厚生","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"645507","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"藤林 康久","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"645508","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"張 明栄","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"645509","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":"[M1VIA3]放医研における18F-FDG注射液の受託試験の信頼性保証について","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"[M1VIA3]放医研における18F-FDG注射液の受託試験の信頼性保証について"}]},"item_type_id":"10005","owner":"1","path":["29"],"pubdate":{"attribute_name":"公開日","attribute_value":"2014-11-18"},"publish_date":"2014-11-18","publish_status":"0","recid":"65539","relation_version_is_last":true,"title":["[M1VIA3]放医研における18F-FDG注射液の受託試験の信頼性保証について"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T20:58:55.608417+00:00"}