Hideki Maeda

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Meiji Pharmaceutical University

Japan

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Recent Grants

Grant: Close

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

Open Date: 2023-04-01

Close Date: 2026-03-01

Grant: Close

Research on the reconstruction of post-marketing safety measures for pharmaceutical products in view of the next system revision

Open Date: 2021-04-01

Close Date: 2024-03-01

Grant: Close

Consideration on drug lag, development start and review time for oncology drugs in Japan.

Open Date: 2020-04-01

Close Date: 2023-03-01

Articles (20)

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2022

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Hideki Maeda

Research Interests

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Contact this professor

Recent Grants

Articles (20)

A cross-sectional study on the first-in-human trials of anticancer drugs in Japan and the United States and the probability of approval.

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

Consideration on Food Effect Studies for Anticancer Drugs Approved in Japan Between 2001 and 2022

Comparison of National Lists of Essential Medicine among Japan, the United States of America, the European Union, the World Health Organization, Thailand, and China

Characterization of Japanese Risk Management Plans after 10 Years of Implementation: 2013–2023

Potential surrogate endpoint for B-cell hematologic malignancy: A systematic review and meta-analysis

Added Therapeutic Benefits of Top‐Selling Drugs in Japan: A Cross‐Sectional Study Using Health Technology Assessment

Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval

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

Gender differences in pharmacy professors in Japan and Korea

Correlation of Anticancer Drug Prices with Outcomes of Overall Survival and Progression-Free Survival in Clinical Trials in Japan

Comparison of the Speed of Enrollment for Clinical Trials Conducted by Japanese and Global Pharmaceutical Companies

Comparing cancer drug approval systems in the United States and Japan

Assessment of Surrogate End Point Trends in Clinical Trials to Approve Oncology Drugs From 2001 to 2020 in Japan

Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999–2019

Consideration for the trends on drug lag in oncology drugs during the last two decades in Japan; 2001-2020

Characteristics of the Compassionate Use Program in Japan: An Analysis of Expanded Access Clinical Trials from 2016 to 2021

Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan

Lag Time for New Innovative, First-in-Class, Drug Approval in Japan

The Current Status and Future Direction of Clinical Research in Japan From a Regulatory Perspective

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