The MIHARI project: establishing a new framework for pharmacoepidemiological drug safety assessments by the Pharmaceuticals and Medical Devices Agency of Japan

Ishiguro Chieko; Takeuchi Yoshinori; Uyama Yoshiaki; Tawaragi Tomiko

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The MIHARI project: establishing a new framework for pharmacoepidemiological drug safety assessments by the Pharmaceuticals and Medical Devices Agency of Japan

机译：MIHARI项目：由日本药物及医疗器械局建立药物流行病学药物安全性评估的新框架

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来源
《Pharmacoepidemiology and drug safety》 |2016年第7期|共6页
作者
Ishiguro Chieko; Takeuchi Yoshinori; Uyama Yoshiaki; Tawaragi Tomiko;
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原文格式 PDF
正文语种 eng
中图分类药学;
关键词
pharmacoepidemiology; post-marketing drug safety; regulatory science; pharmacoepidemiology;

机译：药物流行病学;上市后药物安全性;法规科学;药物流行病学;

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1. The MIHARI project: establishing a new framework for pharmacoepidemiological drug safety assessments by the Pharmaceuticals and Medical Devices Agency of Japan [J] . Ishiguro Chieko, Takeuchi Yoshinori, Uyama Yoshiaki, Pharmacoepidemiology and drug safety . 2016,第7期

机译：MIHARI项目：由日本药物及医疗器械局建立药物流行病学药物安全性评估的新框架
2. The utilization and challenges of Japan's MID-NET (R) medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies [J] . Itoh Maori, Uyama Yoshiaki, Ando Takashi, Pharmacoepidemiology and drug safety . 2019,第5期

机译：日本中期（r）医疗信息数据库网络在邮外市场药物安全评估中的利用与挑战：试点药物遗传学研究综述
3. Severe drug eruptions due to lamotrigine in Japan based on data from the relief system of the Pharmaceuticals and Medical Devices Agency [J] . Hidehisa Saeki, Kazuo Yamada, Norifumi Morikawa, Allergology international: official journal of the Japanese Society of Allergology . 2017,第1期

机译：根据药品和医疗器械局的救济系统提供的数据，日本因拉莫三嗪而导致的严重药疹
4. Safety assessment reevaluation of Biotechnology-Derived Pharmaceuticals as the imperative for getting renewed Marketing Authorisation Approval (MAA) Experience from Medicies and Medical Devices Agency of Serbia-Alims [C] . Stanimirovic V., Nikolic D., Nikolic A., European Congress of Pharmacology . 2012

机译：生物技术衍生的药物的安全评估重新评估为塞尔维亚 - Alims的Medicies和医疗器械机构获得营销授权批准（MAA）的必要性
5. Integrating relational data frameworks into risk assessment of networked medical devices. [D] . Seale, Katherine Augusta. 2017

机译：将关系数据框架集成到网络医疗设备的风险评估中。
6. Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency Japan [O] . Nobuhiro Handa, Kensuke Ishii, Yutaka Matsui, 2015

机译：向日本药品和医疗器械局报告心血管医疗器械不良事件
7. Severe drug eruptions due to lamotrigine in Japan based on data from the relief system of the Pharmaceuticals and Medical Devices Agency [O] . Hidehisa Saeki, Kazuo Yamada, Norifumi Morikawa, 2017

机译：根据制药和医疗器械局救济系统的数据，日本拉莫三嗪引发的严重药疹
8. Advances in FDAs Safety Program for Marketed Drugs: Establishing Premarket Safety Review and Marketed Drug Safety as Equal Priorities at FDAs Center for Drug Evaluation and Research. [R] . 2012

机译：FDas安全计划在市场营销中的应用：在FDas药物评估和研究中心建立上市前安全审查和上市药物安全作为平等优先事项。

The MIHARI project: establishing a new framework for pharmacoepidemiological drug safety assessments by the Pharmaceuticals and Medical Devices Agency of Japan

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