{"created":"2023-05-15T15:03:56.552475+00:00","id":86497,"links":{},"metadata":{"_buckets":{"deposit":"43ae8d37-2637-4940-ba65-08889077d582"},"_deposit":{"created_by":1,"id":"86497","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"86497"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00086497","sets":["1"]},"author_link":["1056227","1056241","1056239","1056231","1056235","1056238","1056226","1056228","1056232","1056233","1056237","1056230","1056234","1056240","1056225","1056229","1056236"],"item_8_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2022-05","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"2","bibliographicPageEnd":"177","bibliographicPageStart":"161","bibliographicVolumeNumber":"12","bibliographic_titles":[{"bibliographic_title":"レギュラトリーサイエンス学会誌"}]}]},"item_8_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"近年，治療分野での放射性医薬品開発は，大手製薬企業が参入するなど，グローバルで活発化している．放射性医薬品の一つの特徴として，リガンド自体が薬理作用を示すのではなく，標識された微量の放射性同位元素（RI）が放射性壊変した際に放出する放射線により効能または効果を示すことがあげられる．その特性から，放射性医薬品では一般医薬品とは異なる品質・安全性の評価手法が必要とされ，一般医薬品を対象とするガイドラインにおいて適用対象外とされているケースも珍しくない．本邦における放射性医薬品開発に関するガイドラインとしては，「診断用放射性医薬品の臨床評価方法に関するガイドライン（平成24年6月11日付薬食審査発0611第1号）」があげられるが，治療用放射性医薬品開発に関する文書は発出されていない．診断薬と治療薬では医薬品開発としての戦略が異なる側面も多く，ガイドライン類の発出が望まれている．一方，米国食品医薬品局（FDA）からは，腫瘍治療用放射性医薬品の非臨床試験および添付文書に関するガイダンス「Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry（Guidance for Industry，FDA-2018-D-1772）」が発出されている（2019年8月）．また，欧州医薬品庁（EMA）からは，「Guideline on the non-clinical requirements for radiopharmaceuiticals」（ドラフト段階）が出されている（2018年11月）．今回筆者らは，FDA発出のガイダンスの日本語訳を作成し，また，ガイダンスのより深い理解のために追加説明が必要であると判断した箇所に，補足を挿入した．前述したとおり，本邦において治療用放射性医薬品開発に関する文書は発出されていない状況であり，今後，FDAやEMAから発出されている文書などを参照し，ガイドライン整備を進めることが，本邦における放射性医薬品の開発を進める上で重要になると考えられる．","subitem_description_type":"Abstract"}]},"item_8_publisher_8":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"一般社団法人レギュラトリーサイエンス学会"}]},"item_8_relation_14":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type_id":{"subitem_relation_type_id_text":"10.14982/rsmp.12.161","subitem_relation_type_select":"DOI"}}]},"item_8_relation_17":{"attribute_name":"関連サイト","attribute_value_mlt":[{"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://www.jstage.jst.go.jp/article/rsmp/12/2/12_161/_article/-char/ja/","subitem_relation_type_select":"URI"}}]},"item_8_source_id_9":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"2185-7113","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":"蜂須賀, 暁子"}],"nameIdentifiers":[{"nameIdentifier":"1056225","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"東, 達也"}],"nameIdentifiers":[{"nameIdentifier":"1056226","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"細野, 眞"}],"nameIdentifiers":[{"nameIdentifier":"1056227","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"小野, 正博"}],"nameIdentifiers":[{"nameIdentifier":"1056228","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"上原, 知也"}],"nameIdentifiers":[{"nameIdentifier":"1056229","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"西村, 伸太郎"}],"nameIdentifiers":[{"nameIdentifier":"1056230","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"村上, 学"}],"nameIdentifiers":[{"nameIdentifier":"1056231","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"渡邉, リラ"}],"nameIdentifiers":[{"nameIdentifier":"1056232","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"根元, 貴行"}],"nameIdentifiers":[{"nameIdentifier":"1056233","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"高井, 希望"}],"nameIdentifiers":[{"nameIdentifier":"1056234","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"西條, 武明"}],"nameIdentifiers":[{"nameIdentifier":"1056235","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"波多野, 正"}],"nameIdentifiers":[{"nameIdentifier":"1056236","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"眞矢, 啓史"}],"nameIdentifiers":[{"nameIdentifier":"1056237","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"竹森, 英晃"}],"nameIdentifiers":[{"nameIdentifier":"1056238","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"香本, 祥太"}],"nameIdentifiers":[{"nameIdentifier":"1056239","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"佐治, 英郎"}],"nameIdentifiers":[{"nameIdentifier":"1056240","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Tatsuya, Higashi","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"1056241","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":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"FDA ガイダンス「Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry」の日本語訳および補足説明","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"FDA ガイダンス「Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry」の日本語訳および補足説明"}]},"item_type_id":"8","owner":"1","path":["1"],"pubdate":{"attribute_name":"公開日","attribute_value":"2022-07-01"},"publish_date":"2022-07-01","publish_status":"0","recid":"86497","relation_version_is_last":true,"title":["FDA ガイダンス「Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry」の日本語訳および補足説明"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T16:55:16.136979+00:00"}