• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impacts of Regulatory Actions and Safety Risk of a Drug at Postmarketing Stage.

作者信息

Kajiyama Kazuhiro, Komamine Maki, Horiuchi Naoya, Iguchi Toyotaka, Uyama Yoshiaki

机构信息

Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

Office of Regulatory Science Research, Center for Regulatory Science, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

出版信息

Pharmacoepidemiol Drug Saf. 2024 Sep;33(9):e70007. doi: 10.1002/pds.70007.

DOI:10.1002/pds.70007
PMID:39238427
Abstract
摘要

相似文献

1
PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impacts of Regulatory Actions and Safety Risk of a Drug at Postmarketing Stage.药品和医疗器械管理局关于用于监管目的的真实世界数据/真实世界证据利用的观点，包括对监管行动的影响以及药品上市后阶段安全风险的评估。
Pharmacoepidemiol Drug Saf. 2024 Sep;33(9):e70007. doi: 10.1002/pds.70007.
2
Sequential surveillance for drug safety in a regulatory environment.监管环境下药品安全性的序贯监测。
Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):707-712. doi: 10.1002/pds.4407. Epub 2018 Mar 5.
3
U.S. postmarketing pharmacovigilance compliance in the midst of regulatory uncertainty.在监管不确定性背景下美国上市后药物警戒的合规情况
Food Drug Law J. 2007;62(3):513-28.
4
The role of databases in drug postmarketing surveillance.数据库在药品上市后监测中的作用。
Pharmacoepidemiol Drug Saf. 2001 Aug-Sep;10(5):407-10. doi: 10.1002/pds.615.
5
The future of population-based postmarket drug risk assessment: a regulator's perspective.基于人群的上市后药物风险评估的未来：监管者视角。
Clin Pharmacol Ther. 2013 Sep;94(3):349-58. doi: 10.1038/clpt.2013.118. Epub 2013 Jun 5.
6
Pediatric post-marketing safety systems in North America: assessment of the current status.北美的儿科上市后安全系统：现状评估
Pharmacoepidemiol Drug Saf. 2015 Aug;24(8):785-92. doi: 10.1002/pds.3813. Epub 2015 Jun 22.
7
Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.评估定期上市后安全性总结分析对监管行动的影响。
Clin Pharmacol Ther. 2016 Jul;100(1):102-8. doi: 10.1002/cpt.346. Epub 2016 Mar 31.
8
Pharmacovigilance: Importance, concepts, and processes.药物警戒：重要性、概念与流程。
Am J Health Syst Pharm. 2017 Apr 15;74(8):606-612. doi: 10.2146/ajhp151031. Epub 2017 Feb 24.
9
The utilization and challenges of Japan's MID-NET medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies.日本 MID-NET 医疗信息数据库网络在后市场药物安全性评估中的利用与挑战：试点药物流行病学研究总结。
Pharmacoepidemiol Drug Saf. 2019 May;28(5):601-608. doi: 10.1002/pds.4777. Epub 2019 Apr 3.
10
Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan.药物获益-风险评估中使用真实世界证据在日本的监管决策方面的接受和使用情况的演变
Clin Pharmacol Ther. 2022 Jan;111(1):35-43. doi: 10.1002/cpt.2410. Epub 2021 Sep 18.

引用本文的文献

1
Trends in the use of validated claims-based algorithms in Japanese post-marketing database studies.日本上市后数据库研究中基于验证后的索赔算法的使用趋势。
Front Pharmacol. 2025 Sep 2;16:1642490. doi: 10.3389/fphar.2025.1642490. eCollection 2025.
2
Author response to: OSIN-D-24-01586, "Revisiting the safety of romosozumab in Japan: the need for clear contraindications for patients with cardiovascular risk".作者对编号为OSIN-D-24-01586的“重新审视日本罗莫佐单抗的安全性：明确心血管风险患者的禁忌证的必要性”的回复。
Osteoporos Int. 2025 Mar;36(3):565-567. doi: 10.1007/s00198-024-07348-2. Epub 2025 Jan 8.