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Author

Hideki Maeda

3 papers indexed here

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Review Open access Sep 2026

Race and trial region changes in cancer clinical trials between 2013 and 2024

Background The latest changes in racial and geographical enrollment in cancer clinical trials in the 2020s have not been fully characterized, despite ongoing measures by the US Food and Drug Administration (FDA) to enhance diversity. We aimed to quantitatively elucidate the trial population of FDA-approved cancer drugs...

Satoshi Hirano, Keisuke Hanada, Hideki Maeda · 0 citations
Open access Sep 2026

Important potential risks not reflected in Japanese drug labeling: implications for risk management plan termination

Risk management plans (RMPs) support lifecycle management of drug-related risks. In Japan, however, their use in clinical practice remains limited, and healthcare professionals often rely on the package insert for safety information. After RMP termination at re-examination, healthcare professionals may no longer readil...

Natsuko Kameyama, Ayana Ide, Hideki Maeda · 0 citations
Open access Sep 2026

Approval lag and loss for biologic-device combination products in Japan and the United States

Introduction The market for drug delivery devices (DDDs), including combination products that integrate pharmaceuticals and medical devices, has expanded rapidly with the increasing use of biopharmaceuticals and growing adoption of self-administration. However, the extent and causes of approval lag and approval loss fo...

Maki Mochizuki, Hideki Maeda · 0 citations

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