Characteristics of the Compassionate Use Program in Japan: An Analysis of Expanded Access Clinical Trials from 2016 to 2021
Author:
Affiliation:
1. Department of Regulatory Science, Faculty of Pharmacy Meiji Pharmaceutical University Tokyo Japan
2. Global Regulatory Science Gifu Pharmaceutical University Gifu Japan
3. Astellas Pharma Inc. Tokyo Japan
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2641
Reference36 articles.
1. Diagnosing the decline in pharmaceutical R&D efficiency
2. Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan
3. FDA Breakthrough Therapy Designation–Trial Design and More – Commentary
4. Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval
5. Impact of Regulatory Incentive Programs on the Future of Pediatric Drug Development
Cited by 7 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. Addressing the knowledge gap in the genomic landscape and tailored therapeutic approaches to adolescent and young adult cancers;ESMO Open;2024-08
2. A Qualitative Interview Study on Expanded Access Clinical Trials for Compassionate Use in Japan;Patient Preference and Adherence;2024-07
3. Availability of genome-matched therapy based on clinical practice;International Journal of Clinical Oncology;2024-04-26
4. Efficacy and safety of compassionate use for rare diseases: a scoping review from 1991 to 2022;Orphanet Journal of Rare Diseases;2023-11-28
5. Trastuzumab deruxtecan in patients with locally advanced or metastatic HER2-positive gastric cancer: a multicenter, open-label, expanded-access study;International Journal of Clinical Oncology;2023-11-14
1.学者识别学者识别
2.学术分析学术分析
3.人才评估人才评估
"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370
www.globalauthorid.com
TOP
Copyright © 2019-2024 北京同舟云网络信息技术有限公司 京公网安备11010802033243号 京ICP备18003416号-3