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米国RDRCシステムにおけるPET分子イメージングと創薬開発
https://repo.qst.go.jp/records/57784
https://repo.qst.go.jp/records/57784b2b112f2-91cb-4845-aefb-d653b37ec2f0
| Item type | 一般雑誌記事 / Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2010-10-15 | |||||
| タイトル | ||||||
| タイトル | 米国RDRCシステムにおけるPET分子イメージングと創薬開発 | |||||
| 言語 | ||||||
| 言語 | jpn | |||||
| 資源タイプ | ||||||
| 資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
| 資源タイプ | article | |||||
| 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 |
栗原, 千絵子
× 栗原, 千絵子× 井上, 登美夫× 栗原 千絵子× 井上 登美夫 |
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| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | This is a commentary on the interview with David Yang, Professor, Department of ExperimentalDiagnostic Imaging, The University of Texas M.D. Anderson Cancer Center, by Tomio Inoue, Professor,Yokohama City University, and Chieko Kurihara, Senior Researcher, National Institute of RadiologicalSciences. The interview was held on November 18, 2009, in Yokohama, Japan. Translation of thetranscription of the interview is included in this issue of Clinical Evaluation. In this commentary, we explained the background of the discussion with Prof. Yang, concerningguidance documents by United States Food and Drug Administration (FDA) on medical imaging drug:safety assessment; clinical indications; trial design, current Good Manufacturing Practice of PET drugs,and on the Radioactive Drug Research Committee (RDRC). In particular, the RDRC system is unique andeffective to be utilized for basic clinical research to determine the bio-distribution of drugs or biochemicalprocesses of human. It is also effective to switch the usages of this RDRC framework and the other inwhich investigational new drug (IND) applications are submitted to FDA (IND framework). They can getthrough pipelines of drug development, from finding biochemical information in academia, in RDRCframework, towards diagnostic or therapeutic assessment of efficacy and safety of the drug in collaborationof academia and industry, in IND framework. The authors wish to introduce this kind of system to Japanthrough our activity of the Molecular Imaging Strategic task force of the Society of Nuclear Medicine topromote molecular imaging clinical research and drug development in Japan. |
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| 書誌情報 |
臨床評価 巻 38, 号 2, p. 353-358, 発行日 2010 |
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| ISSN | ||||||
| 収録物識別子タイプ | ISSN | |||||
| 収録物識別子 | 0300-3051 | |||||
