Rchr
J-GLOBAL ID：202001017716669579
Update date: Dec. 27, 2025
Maeda Hideki
マエダ ヒデキ | Maeda Hideki
Affiliation and department：
Job title：
Professor
Homepage URL (2)：
https://www.my-pharm.ac.jp/education/kdb/kyoin/kyoin_159.html
,
https://www.my-pharm.ac.jp/en/research/laboratories/post.html
Research theme for competitive and other funds (4)：
- 2023 - 2026 Study on surrogate end points of clinical trials for supporting drug approvals.
- 2022 - 2025 Research on product recalls of pharmaceuticals and medical devices in Japan.
- 2021 - 2024 Research on the reconstruction of post-marketing safety measures for pharmaceutical products in view of the next system revision
- 2020 - 2023 Consideration on drug lag, start timing of clinical development and review timefor oncology drug in Japan.
Papers (54)：
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Ayaka Kikuchi, Asuka Hara, Akihiko Ozaki, Natsuya Sakata, Hiroaki Saito, Tetsuya Tanimoto, Hideki Maeda. Interactions Between Pharmaceutical Companies and Patient Advocacy Groups in Japan: A Qualitative and Quantitative Interview Study. Risk Management and Healthcare Policy. 2025
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Shunsuke Nakatani, Takuya Hayashi, Aoi Hosaka, Hideki Maeda. Prognostic value of HER2 discordance between primary and metastatic or recurrent breast cancer: a systematic review and meta-analysis. Critical reviews in oncology/hematology. 2025. 105016-105016
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Yuko Yamamoto, Harumi Kosaka, Hanami Nojiri, Hideki Maeda. Surrogate Endpoints in Pivotal Clinical Trials for Drug Approval in Japan Compared to the United States. Clinical and translational science. 2025. 18. 11. e70413
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Akari Mukaida, Hideki Maeda. A cross-sectional study on the first-in-human trials of anticancer drugs in Japan and the United States and the probability of approval. International journal of clinical oncology. 2025
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Keiko Yamamoto, Kentaro Takeda, Hideki Maeda. Retrospective Analysis of Master Protocols in Tumor-Agnostic Drug Development: Evaluation of Application to Single-Agent Therapies With ORR as the Endpoint for Approval of Oncology Drugs. Clinical and translational science. 2025. 18. 8. e70313
ｍore...
MISC (55)：
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北垣 博恵, 武田 健太朗, 村井 和哉, 前田 英紀. 抗がん剤開発における用量最適化 市販後要件及び市販後義務のリスク因子. 日本癌治療学会学術集会抄録集. 2025. 63回. P49-5
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平澤理子, 前田英紀. A cross-sectional study on compassionate use (expanded access clinical trials) of medical devices and regenerative medicine products in Japan. 月刊Precision Medicine. 2025. 8. 12
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望月真紀子, 望月真紀子, 前田英紀. コンビネーション医薬品と医療機器に分類されるドラッグデリバリーデバイスの市場動向とオートインジェクターの規制上の課題. レギュラトリーサイエンス学会誌. 2025. 15. Supplement
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小林孝二郎, 小林孝二郎, 前田英紀. 米国の薬事的特別措置が日本の抗がん剤の薬価収載に与える影響について. レギュラトリーサイエンス学会誌. 2025. 15. Supplement
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平野誠巳, 花田圭介, 前田英紀. B細胞性血液がんにおける早期代替エンドポイントの後方視的解析. レギュラトリーサイエンス学会誌. 2025. 15. Supplement
ｍore...
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