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Approval Disparities for New Drugs in the US and Japan.

作者信息

Kasahara Shingo, Wakutsu Naohiko, Nakamura Hiroshi

机构信息

Keio University, Yokohama, Japan.

Nagoya City University, Nagoya, Aichi, Japan.

出版信息

JAMA Netw Open. 2025 Jun 2;8(6):e2513640. doi: 10.1001/jamanetworkopen.2025.13640.

DOI:10.1001/jamanetworkopen.2025.13640
PMID:40493372
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12152698/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/36b8/12152698/88c19d2e9a52/jamanetwopen-e2513640-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/36b8/12152698/88c19d2e9a52/jamanetwopen-e2513640-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/36b8/12152698/88c19d2e9a52/jamanetwopen-e2513640-g001.jpg

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本文引用的文献

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Bridging the new drug access gap between China and the United States and its related policies.弥合中美两国新药可及性差距及其相关政策。
Front Pharmacol. 2024 Jan 8;14:1296737. doi: 10.3389/fphar.2023.1296737. eCollection 2023.
2
Trends in oncology drug lags in Japan from 2001 to 2020: A cross-sectional study.2001 年至 2020 年日本肿瘤药物研发滞后趋势：一项横断面研究。
Clin Transl Sci. 2023 Dec;16(12):2665-2674. doi: 10.1111/cts.13660. Epub 2023 Oct 17.
3
Increasing orphan drug loss in Japan: Trends and R&D strategy for rare diseases.
日本孤儿药损失增加：罕见病的趋势和研发策略。
Drug Discov Today. 2023 Oct;28(10):103755. doi: 10.1016/j.drudis.2023.103755. Epub 2023 Aug 28.
4
Availability of New Medicines in the US and Germany From 2004 to 2018.2004 年至 2018 年美国和德国新药的供应情况。
JAMA Netw Open. 2022 Aug 1;5(8):e2229231. doi: 10.1001/jamanetworkopen.2022.29231.
5
Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia.美国、欧盟、瑞士、日本、加拿大和澳大利亚的癌症药物的临床获益和加速审批。
JCO Oncol Pract. 2022 Sep;18(9):e1522-e1532. doi: 10.1200/OP.21.00909. Epub 2022 Jun 22.
6
An Empirical Analysis of Japan's Drug Development Lag Behind the United States.日本药物研发落后于美国的实证分析
J Clin Pharmacol. 2022 Jul;62(7):847-854. doi: 10.1002/jcph.2023. Epub 2022 Feb 8.