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

Comparison of regulatory approval system for medicines in emergency among Japan, the United States, the United Kingdom, Europe, and China.

Edo K, 真秀川野, Hideki Maeda

PloS one, Sep 16, 2024
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
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
Current situation and issues regarding termination of risk management plans in Japan

Natsuko Kameyama, Aoi Hosaka, Hideki Maeda

Frontiers in Medicine, May 30, 2024
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
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
Comparison of the Speed of Enrollment for Clinical Trials Conducted by Japanese and Global Pharmaceutical Companies

Hideki Maeda, Moeka Yamanoi, Yuka Fukuda, Yuina Inaba

Biological and Pharmaceutical Bulletin, 46(9) 1289-1295, Sep 1, 2023 Peer-reviewedLead authorCorresponding author
Comparing cancer drug approval systems in the United States and Japan

Yudai Kaneda, Hideki Maeda, Akihiko Ozaki, Yuka Higuchi, Tetsuya Tanimoto

Health Science Reports, 6(5) e1265, May 10, 2023 Peer-reviewed
Assessment of Surrogate End Point Trends in Clinical Trials to Approve Oncology Drugs From 2001 to 2020 in Japan.

Hideki Maeda, Riko Shingai, Kentaro Takeda, Asuka Hara, Yuna Murai, Momoka Ofuchi

JAMA network open, 6(4) e238875, Apr 3, 2023 Peer-reviewedLead authorCorresponding author
Correlation of Anticancer Drug Prices with Outcomes of Overall Survival and Progression-Free Survival in Clinical Trials in Japan

Ayano Okabe, Haruto Hayashi, Hideki Maeda

Current Oncology, 30(2) 1776-1783, Feb 1, 2023 Peer-reviewedLast authorCorresponding author
Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999–2019

Minami Nakao, Yuri Nakamura, Masafumi Shimokawa, Hideki Maeda

International Journal of Clinical Pharmacy, 45(1) 108-116, Nov 2, 2022 Peer-reviewedLast authorCorresponding author
Characteristics of the Compassionate Use Program in Japan: An Analysis of Expanded Access Clinical Trials from 2016 to 2021.

Hideki Maeda, Marika Uchida, Mikiko Kusano, Katsura Tsukamoto, Moeka Yamanoi

Clinical pharmacology and therapeutics, 112(4) 817-823, Oct, 2022 Peer-reviewedLead authorCorresponding author
Consideration for the trends on drug lag in oncology drugs during the last two decades in Japan; 2001-2020

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

Annals of Oncology, 33, Jul, 2022
Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan

Hideki Maeda, Daniel Bin Ng

Frontiers in Medicine, 9, Apr 15, 2022 Peer-reviewedLead authorLast authorCorresponding author
The Current Status and Future Direction of Clinical Research in Japan From a Regulatory Perspective

Hideki Maeda

Frontiers in Medicine, 8, Jan 13, 2022 Peer-reviewedLead authorLast authorCorresponding author
Lag Time for New Innovative, First-in-Class, Drug Approval in Japan.

Takayuki Miyazaki, Michiyuki Komiyama, Naoki Matsumaru, Hideki Maeda, Katsura Tsukamoto

Biological & pharmaceutical bulletin, 45(4) 477-482, 2022 Peer-reviewed
Relationships between developmental strategies for additional indications and price revisions for anticancer drugs in Japan.

Hideki Maeda, Ayano Okabe, Kenichi Sakakura, Daniel Bin Ng, Manabu Akazawa

BMC health services research, 21(1) 1329-1342, Dec 11, 2021 Peer-reviewedLead authorCorresponding author
Study of the compatibility of oral magnesium oxide preparations sold in Japan with the ICH-Q3D guideline for elemental impurities.

Mitsutoshi Satoh, Kimitaka Motokawa, Yoshihiro Uesawa, Yoichi Ishikawa, Hideki Maeda, Katsumi Iida, Hiroyuki Tanaka, Takayoshi Kosugi, Kenji Nishizawa

Drug discoveries & therapeutics, 15(5) 227-235, Nov 21, 2021 Peer-reviewed
4

Regulatory approval with real world data from regulatory science perspective

Hideki Maeda

Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku, 26(Supplement) S69-S70, Nov, 2021 Peer-reviewedInvitedLead authorLast authorCorresponding author
Medical Affairs in Pharmaceutical Companies and Related Pharmaceutical Regulations in Japan

Hideki Maeda

Frontiers in Medicine, 8 672095-672095, Aug 9, 2021 Peer-reviewedLead authorCorresponding author

Major Misc.

日本発の創薬革命-革新的創薬・育薬に向けたアカデミア・行政・企業の果たすべき役割-早期・探索臨床研究の実際-医薬品開発をリードする国の1つとして-日本企業における日本でのFIH,早期・探索的臨床試験への取り組み

前田英紀

臨床医薬, 30(10) 835-840, 2014 Lead authorLast authorCorresponding 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

Profile Information

Papers

Major Misc.

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