{"created":"2023-06-20T16:49:33.397180+00:00","id":21799,"links":{},"metadata":{"_buckets":{"deposit":"f826560b-4efa-4d20-9eb9-8f60adb3bc3f"},"_deposit":{"created_by":3,"id":"21799","owners":[3],"pid":{"revision_id":0,"type":"depid","value":"21799"},"status":"published"},"_oai":{"id":"oai:kindai.repo.nii.ac.jp:00021799","sets":["14:923:1477:4678"]},"author_link":["37606","37607","37605"],"item_2_biblio_info_21":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2021-06-25","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"1-2","bibliographicPageEnd":"31","bibliographicPageStart":"13","bibliographicVolumeNumber":"46","bibliographic_titles":[{"bibliographic_title":"近畿大学医学雑誌"},{"bibliographic_title":"Medical Journal of Kindai University","bibliographic_titleLang":"en"}]}]},"item_2_description_33":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"[抄録]抗悪性腫瘍薬は,悪性腫瘍病変の増大や転移の抑制,又は延命,症状コントロール等の何らかの臨床的有用性を悪性腫瘍患者において示す医薬品を指し,低分子化合物,抗体,ワクチン,腫瘍溶解性ウイルス,キメラ抗原受容体T細胞等,多様なものが含まれる.近年,相次いで画期的な抗悪性腫瘍薬が登場し,多くの悪性腫瘍の治療においてパラダイムシフトを起こしている.抗悪性腫瘍薬を含む医薬品の開発では,基礎研究の着手から,規制当局における審査,厚生労働大臣による承認までに,長い年月と莫大な研究開発費が必要となる.そのため,開発企業は薬事上の特別措置を利用し,「より良い薬をより早く」実用化するべく工夫を凝らす.一方で,抗悪性腫瘍薬の臨床的有用性を審査する立場にある規制当局では,その判断の誤りが患者の生命・健康に直結することがあるため,様々なピットフォールに注意しつつ,慎重な姿勢で審査に臨む.欧米と比較し,悪性腫瘍の患者数が多くない我が国では,抗悪性腫瘍薬の開発における様々な課題が存在する.これらの課題を迅速に解決してゆくためには,産官学連携に基づくオールジャパンの体制づくりが重要となる.","subitem_description_type":"Abstract"}]},"item_2_description_41":{"attribute_name":"フォーマット","attribute_value_mlt":[{"subitem_description":"application/pdf","subitem_description_type":"Other"}]},"item_2_identifier_registration":{"attribute_name":"ID登録","attribute_value_mlt":[{"subitem_identifier_reg_text":"10.15100/00021774","subitem_identifier_reg_type":"JaLC"}]},"item_2_publisher_14":{"attribute_name":"出版者 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Rheumatology, Faculty of Medicine, Kindai University: Office of New Drug V, Pharmaceuticals and Medical Devices Agency"},{"subitem_text_value":"Clinical Research Center,Kindai University Hospital"}]},"item_2_version_type_12":{"attribute_name":"版","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_be7fb7dd8ff6fe43","subitem_version_type":"NA"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"平瀬, 主税"},{"creatorName":"ヒラセ, チカラ","creatorNameLang":"ja-Kana"}],"nameIdentifiers":[{"nameIdentifier":"37605","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"佐野, 圭吾"},{"creatorName":"サノ, ケイゴ","creatorNameLang":"ja-Kana"}],"nameIdentifiers":[{"nameIdentifier":"37606","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"福岡, 和也"},{"creatorName":"フクオカ, 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