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How long does it take to develop a new drug?

作者信息

Möhrle Jörg J

机构信息

Medicines for Malaria Venture, Geneva, Switzerland.

Swiss Tropical and Public Health Institute, Allschwil, Switzerland.

出版信息

Lancet Reg Health Eur. 2024 Jul 4;43:100998. doi: 10.1016/j.lanepe.2024.100998. eCollection 2024 Aug.

DOI:10.1016/j.lanepe.2024.100998
PMID:39070760
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11283072/
Abstract
摘要

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本文引用的文献

1
Factors associated with acceleration of clinical development for infectious diseases: a cross-sectional analysis of 10-year EMA registration data.传染病临床开发加速的相关因素：对欧洲药品管理局10年注册数据的横断面分析
Lancet Reg Health Eur. 2024 Jun 24;43:100983. doi: 10.1016/j.lanepe.2024.100983. eCollection 2024 Aug.
2
Uptake of the multi-arm multi-stage (MAMS) adaptive platform approach: a trial-registry review of late-phase randomised clinical trials.多臂多阶段（MAMS）自适应平台方法的应用：晚期随机临床试验的试验注册回顾。
BMJ Open. 2022 Mar 10;12(3):e055615. doi: 10.1136/bmjopen-2021-055615.
3
Clinical development times for innovative drugs.创新药物的临床开发时间。
Nat Rev Drug Discov. 2022 Nov;21(11):793-794. doi: 10.1038/d41573-021-00190-9.
4
The European Medicines Agency facilitates access to medicines in low- and middle-income countries.欧洲药品管理局为中低收入国家提供药品准入渠道。
Expert Rev Clin Pharmacol. 2020 Mar;13(3):321-325. doi: 10.1080/17512433.2020.1724782. Epub 2020 Feb 13.
5
Trial watch: Clinical trial cycle times continue to increase despite industry efforts.试验观察：尽管行业做出了努力，但临床试验周期仍在持续延长。
Nat Rev Drug Discov. 2017 Mar;16(3):157. doi: 10.1038/nrd.2017.21. Epub 2017 Feb 10.