Hideki Maeda

Profile Information

Affiliation: Professor (PhD), Laboratory of Regulatory Science, Department of Clinilcal Pharmacy, Meiji Pharmaceutical University

Contact information: maedamy-pharm.ac.jp
Researcher number: 90870048
ORCID iD: https://orcid.org/0000-0002-0117-3961
J-GLOBAL ID: 202001017716669579
researchmap Member ID: R000003055

External link: https://www.my-pharm.ac.jp/en/research/laboratories/post.html

Papers

Prognostic value of HER2 discordance between primary and metastatic or recurrent breast cancer: a systematic review and meta-analysis.

Shunsuke Nakatani, Takuya Hayashi, Aoi Hosaka, Hideki Maeda

Critical reviews in oncology/hematology, 105016-105016, Nov 11, 2025
Surrogate Endpoints in Pivotal Clinical Trials for Drug Approval in Japan Compared to the United States.

Yuko Yamamoto, Harumi Kosaka, Hanami Nojiri, Hideki Maeda

Clinical and translational science, 18(11) e70413, Nov, 2025
A cross-sectional study on the first-in-human trials of anticancer drugs in Japan and the United States and the probability of approval.

Akari Mukaida, Hideki Maeda

International journal of clinical oncology, Aug 6, 2025 Peer-reviewedLast authorCorresponding author
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.

Keiko Yamamoto, Kentaro Takeda, Hideki Maeda

Clinical and translational science, 18(8) e70313, Aug, 2025 Peer-reviewedLast authorCorresponding author
Comparison of National Lists of Essential Medicine among Japan, the United States of America, the European Union, the World Health Organization, Thailand, and China

Masahide Kawano, Ayaka Kojima, Hideki Maeda

Asian Pacific Journal of Health Economics and Policy, Jul 4, 2025 Peer-reviewedLast authorCorresponding author
Consideration on Food Effect Studies for Anticancer Drugs Approved in Japan Between 2001 and 2022.

Maho Shibuya, Hayataka Kubota, Hideki Maeda

Clinical and translational science, 18(7) e70304, Jul, 2025 Peer-reviewedLast authorCorresponding author
Characterization of Japanese Risk Management Plans after 10 Years of Implementation: 2013-2023.

Sono Sawada, Keiko Asao, Ryohei Kobayashi, Jaclyn Bosco, Hideki Maeda

Therapeutic innovation & regulatory science, Jun 3, 2025 Peer-reviewedCorresponding author
Potential surrogate endpoint for B-cell hematologic malignancy: A systematic review and meta-analysis.

Satoshi Hirano, Keisuke Hanada, Hideki Maeda

Scientific reports, 15(1) 19300-19300, Jun 2, 2025 Peer-reviewedLast authorCorresponding author
Added Therapeutic Benefits of Top-Selling Drugs in Japan: A Cross-Sectional Study Using Health Technology Assessment.

Hayase Hakariya, Akihiko Ozaki, Takanao Hashimoto, Frank Moriarty, Hideki Maeda, Tetsuya Tanimoto

Clinical and translational science, 18(6) e70243, Jun, 2025 Peer-reviewed
Dose Optimization in Oncology Drug Development: Risk Factors for Postmarketing Requirements and Commitments.

Hiroe Kitagaki, Kentaro Takeda, Kazuya Murai, Hideki Maeda

Clinical pharmacology and therapeutics, May 20, 2025 Peer-reviewedLast authorCorresponding author
Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval.

Kojiro Kobayashi, Yuina Inaba, Mayu Hashimoto, Hideki Maeda

Therapeutic innovation & regulatory science, Apr 8, 2025 Peer-reviewedLast authorCorresponding author
Impact of loss of HER2 positivity following neoadjuvant therapy in HER2 positive breast cancer patients on long-term prognosis: A systematic review and meta-analysis

Shunsuke Nakatani, Takuya Hayashi, Keiko Yamamoto

Cancer Treatment Reviews, 135 102923-102923, Mar 17, 2025 Peer-reviewedLast authorCorresponding author
Gender differences in pharmacy professors in Japan and Korea

Hideki Maeda, Hyunseo Soh, Mayu Hashimoto, Euna Han, Eri Ohno

The Lancet Regional Health - Western Pacific, 54 101469-101469, Jan, 2025 Peer-reviewedLead authorCorresponding author
Has risk management plan system influenced the speed of package insert revisions in Japan?

Natsuko Kameyama, Aoi Hosaka, Hideki Maeda

Frontiers in Medicine, Oct 29, 2024 Peer-reviewedLast authorCorresponding author
Trends in the market for drug delivery devices categorized as combination drugs and medical devices and regulatory challenges for autoinjectors in Japan

Makiko Mochizuki, Hideki Maeda

Frontiers in Medical Technology, 6, Aug 6, 2024 Peer-reviewedLast authorCorresponding author
A Qualitative Interview Study on Expanded Access Clinical Trials for Compassionate Use in Japan

Haruto Hayashi, Takehide Nogita, Hideki Maeda

Patient Preference and Adherence, Jul, 2024 Peer-reviewedLast authorCorresponding author
Current situation and issues regarding termination of risk management plans in Japan

Natsuko Kameyama, Aoi Hosaka, Hideki Maeda

Frontiers in Medicine, May 30, 2024 Peer-reviewedLast authorCorresponding author
Adult and pediatric relapsing multiple sclerosis phase II and phase III trial design and their primary end points: A systematic review.

Katsutoshi Hiramatsu, Hideki Maeda

Clinical and translational science, 17(5) e13794, May, 2024 Peer-reviewedLast authorCorresponding author
Comparison of regulatory approval system for medicines in emergency among Japan, the United States, the United Kingdom, Europe, and China.

Kazuki Edo, Masahide Kawano, Hideki Maeda

PloS one, 19(9) e0309992, Sep 16, 2024 Peer-reviewedLast authorCorresponding author
Trends in oncology drug lags in Japan from 2001-2020: A cross-sectional study.

Hideki Maeda, Asuka Hara, Momoka Ofuchi, Riko Shingai, Toshihiro Misumi, Yuna Murai

Clinical and translational science, 16(12) 2665-2674, Oct 10, 2023 Peer-reviewedLead authorCorresponding author

Major Misc.

製造販売後調査及びRWD活用の現状と課題

前田英紀

JAPIC News, (489), 2025
タイの医療保障制度について—Health Security Systems in Thailand

前田英紀

Monthly IHEP, (337) 31-36, Feb, 2024
International Comparison of Reporting Systems for Medical Device Malfunctions

AKAISHI Koko, SATOMI Tomomi, MAEDA Hideki

Regulatory Science of Medical Products, 14(3) 293-306, 2024
Design of First-in-Human Clinical Trial to Acquire Proof of Concept

前田英紀

月刊Pharm Stage, 23(10), 2024
8350

The Establishment of Medical Affairs Functions in Japan-History, Current Status, and Future Perspective-

前田英紀

医薬品医療機器レギュラトリーサイエンス, 51(6-7) 345-353, Jul, 2020 Peer-reviewedLead author

Research Projects

Study on surrogate end points of clinical trials for supporting drug approvals.

JSPS, Grant-in-Aid for Scientific Research (C), Japan Society for the Promotion of Science, Apr, 2023 - Mar, 2026

Hideki Maeda
Research on product recalls of pharmaceuticals and medical devices in Japan.

JSPS, JSPS, Apr, 2022 - Mar, 2025
Research on the reconstruction of post-marketing safety measures for pharmaceutical products in view of the next system revision

Research on Regulatory Science of Pharmaceuticals and Medical Devices, Research on Regulatory Science of Pharmaceuticals and Medical Devices, Health, Labour and Welfare Policy Research Grant, Apr, 2021 - Mar, 2024

Hideki Maeda
Consideration on drug lag, start timing of clinical development and review timefor oncology drug in Japan.

Grants-in-Aid for Scientific Research Grant-in-Aid for Early-Career Scientists, Grant-in-Aid for Early-Career Scientists, Japan Society for the Promotion of Science, Apr, 2020 - Mar, 2023

Maeda Hideki

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