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Opening remarks and Ethics and regulations in Japan and in NEDO MicroDose-PJ
https://repo.qst.go.jp/records/64174
https://repo.qst.go.jp/records/6417484c5c1a9-ddfa-48ad-afc6-6b22ee9b72bf
| Item type | 会議発表用資料 / Presentation(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2010-12-28 | |||||
| タイトル | ||||||
| タイトル | Opening remarks and Ethics and regulations in Japan and in NEDO MicroDose-PJ | |||||
| 言語 | ||||||
| 言語 | eng | |||||
| 資源タイプ | ||||||
| 資源タイプ識別子 | http://purl.org/coar/resource_type/c_c94f | |||||
| 資源タイプ | conference object | |||||
| アクセス権 | ||||||
| アクセス権 | metadata only access | |||||
| アクセス権URI | http://purl.org/coar/access_right/c_14cb | |||||
| 著者 |
Kurihara, Chieko
× Kurihara, Chieko× 栗原 千絵子 |
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| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | In Japan, clinical trials aimed at new drug/device application (NDA) are regulated by the Pharmaceutical Affairs Law, and other clinical research without such aim are regulated by 'Ethical Guideline for Clinical Research' (the Guideline) issued by the Ministry of Health, Labor and Welfare (MHLW). The MHLW issued in 2008 the guidance specific to microdose clinical trial (microdosing) and issued in 2008 guidance on non-clinical research requirements for several stages of clinical trials including microdosing, implementing ICH-M3 guideline. Our project named 'Innovative strategies for drug development using microdosing clinical studies' (NEDO MicroDose-PJ) started October 2010 under the regulation of the Guideline, using marketed drugs, without intention of NDA but with scientific research intention. In our NEDO MicroDose-PJ, Compliance of the researches has been duplicately assured by the ethics committees of the institute where research is conducted and of the University of Tokyo, the affiliation of the Project Leader. This process is most important to assure internal and external reliability of the research. This is especially important because the MHLW authorization is not required in clinical researches without intention of NDA. Additionally, through this process, safety assurance of the test drugs has been integrated by the Project Leader. Even if pharmacological effect is not expected in microdosing, safety of synthesizing process has to be assured. We now conclude that significant points for clinical research in Japan is mainly the validity of ethics committee review and safety assurance of the test drug, and in all the clinical researches in NEDO MicroDose-PJ these issues have been assured. Acknowledgement: This study is a part of 'Innovative strategies for drug development using microdosing clinical studies' (NEDO MicroDose-PJ), sponsored by the New Energy and Industrial Technology Development Organization. |
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| 会議概要（会議名, 開催地, 会期, 主催者等） | ||||||
| 内容記述タイプ | Other | |||||
| 内容記述 | 第31回日本臨床薬理学会年会 | |||||
| 発表年月日 | ||||||
| 日付 | 2010-12-03 | |||||
| 日付タイプ | Issued | |||||
