Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials-Reference-Cited by-同舟云学术

Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials

Published:2021-07 Issue:4 Volume:35 Page:253-260
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Ushijima Satoshi^ORCID,Matsumaru Naoki,Tsukamoto Katsura

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

https://link.springer.com/content/pdf/10.1007/s40290-021-00393-w.pdf

Reference31 articles.

1. Kaitin KI. Deconstructing the drug development process: the new face of innovation. Clin Pharmacol Ther. 2010;87:356–61. https://doi.org/10.1038/clpt.2009.293.

2. Munos B. Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Discov. 2009;8:959–68. https://doi.org/10.1038/nrd2961.

3. IQVIA. Global medicine spending and usage trends outlook to 2024. 2020. https://www.iqvia.com/insights/the-iqvia-institute/reports/global-medicine-spending-and-usage-trends. Accessed 1 Jun 2021.

4. Wardell W. Therapeutic implication of the drug lag. Clin Pharmacol Ther. 1974;15:73–96. https://doi.org/10.1002/cpt197415173.

5. Tsuji K, Tsutani K. Approval of new drugs 1999–2007: comparison of the US, the EU and Japan situations. J Clin Pharm Ther. 2010;35:289–301. https://doi.org/10.1111/j.1365-2710.2009.01099.x.

Cited by 12 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Assessing drug lag in new drug approvals by the Iran Food and Drug Administration compared to the U.S. FDA, EMA, and PMDA: A 20-year analysis (2001–2021);Medicine;2024-06-21

2. Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology;Therapeutic Innovation & Regulatory Science;2024-04-23

3. Different Development Strategies Affecting Japan’s Drug lag between Japan-Based and Foreign-Based Companies;Therapeutic Innovation & Regulatory Science;2024-04-04

4. Trends in oncology drug lags in Japan from 2001 to 2020: A cross‐sectional study;Clinical and Translational Science;2023-10-17

5. Increasing orphan drug loss in Japan: Trends and R&D strategy for rare diseases;Drug Discovery Today;2023-10