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Clinical Pharmacology and Therapeutics|June 10, 2021
Assessment of Drugs Approved by Public Knowledge-Based Applications (Kouchi-shinsei) During the Last Two Decades in JapanHideki Maeda, Yuka Fukuda, Marika Uchida
Clinical and Translational Science|July 15, 2025
Consideration on Food Effect Studies for Anticancer Drugs Approved in Japan Between 2001 and 2022Maho Shibuya, Hayataka Kubota, Hideki Maeda
Current Oncology (Toronto, Ont.)|February 24, 2023
Correlation of Anticancer Drug Prices with Outcomes of Overall Survival and Progression-Free Survival in Clinical Trials in JapanAyano Okabe, Haruto Hayashi, Hideki Maeda
Frontiers in Medicine|June 14, 2024
Current situation and issues regarding termination of risk management plans in JapanNatsuko Kameyama, Aoi Hosaka, Hideki Maeda
Biological & Pharmaceutical Bulletin|September 4, 2023
Comparison of the Speed of Enrollment for Clinical Trials Conducted by Japanese and Global Pharmaceutical CompaniesHideki Maeda, Moeka Yamanoi, Yuka Fukuda, et al.
Therapeutic Innovation & Regulatory Science|April 8, 2025
Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and ApprovalKojiro Kobayashi, Yuina Inaba, Mayu Hashimoto, et al.
Clinical and Translational Science|November 12, 2025
Surrogate Endpoints in Pivotal Clinical Trials for Drug Approval in Japan Compared to the United StatesYuko Yamamoto, Harumi Kosaka, Hanami Nojiri, et al.
Clinical Pharmacology and Therapeutics|May 21, 2025
Dose Optimization in Oncology Drug Development: Risk Factors for Postmarketing Requirements and CommitmentsHiroe Kitagaki, Kentaro Takeda, Kazuya Murai, et al.
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