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From Translational Research to a Large Randomized Clinical Trial : A Long and Streanuous Way from Bench to Bedside
https://doi.org/10.18999/nagjms.69.1-2.9
https://doi.org/10.18999/nagjms.69.1-2.9c874a00a-9fe3-4a53-954d-8ed5c9190b1d
| 名前 / ファイル | ライセンス | アクション |
|---|---|---|
p009-016.pdf (181.8 kB)
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| Item type | 紀要論文 / Departmental Bulletin Paper(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2007-03-19 | |||||
| タイトル | ||||||
| タイトル | From Translational Research to a Large Randomized Clinical Trial : A Long and Streanuous Way from Bench to Bedside | |||||
| 言語 | en | |||||
| 著者 |
Sakamoto, Junichi
× Sakamoto, Junichi× Morita, Satoshi |
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| アクセス権 | ||||||
| アクセス権 | open access | |||||
| アクセス権URI | http://purl.org/coar/access_right/c_abf2 | |||||
| キーワード | ||||||
| 主題Scheme | Other | |||||
| 主題 | Translational research | |||||
| キーワード | ||||||
| 主題Scheme | Other | |||||
| 主題 | Clinical trials | |||||
| キーワード | ||||||
| 主題Scheme | Other | |||||
| 主題 | Large-scale randomized clinical trial | |||||
| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | Several complicated steps are should be necessary to bring bioscientific products successfully to market. Products generated on the bench first have to be called screened for safety in a Phase I clinical trial. This step is called translational research, indicating that the material must be proven safe not only for experimental animals, but also for human subjects. Once the Phase I study is completed, Phase II determines the safety of the bioscientific products on humans, establishing both its maximum tolerated dose and recommended dose. In a Phase II study, the material should be tested for its efficacy against certain diseases. Once it is found to be effective, a comparison between the current actual standard therapy and the new therapy using the newly developed material will be implemented in a large or against scale randomized trial, after which a final decision must be made for its approval as a new drug. The authors have illustrated the steps of: a Phase I translational research by showing the data of a monoclonal antibody A33; a Phase II trial with several combination chemotherapies of chemotherapeutic agents; a Phase III clinical trial through a comparison of antihypertension agents to show the evolutionary process from translational research to a large randomized trial based on their own experience. | |||||
| 言語 | en | |||||
| 出版者 | ||||||
| 出版者 | Nagoya University School of Medicine | |||||
| 言語 | en | |||||
| 言語 | ||||||
| 言語 | eng | |||||
| 資源タイプ | ||||||
| 資源 | http://purl.org/coar/resource_type/c_6501 | |||||
| タイプ | departmental bulletin paper | |||||
| 出版タイプ | ||||||
| 出版タイプ | VoR | |||||
| 出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
| ID登録 | ||||||
| ID登録 | 10.18999/nagjms.69.1-2.9 | |||||
| ID登録タイプ | JaLC | |||||
| ISSN（print） | ||||||
| 収録物識別子タイプ | PISSN | |||||
| 収録物識別子 | 0027-7622 | |||||
| ISSN（Online） | ||||||
| 収録物識別子タイプ | EISSN | |||||
| 収録物識別子 | 2186-3326 | |||||
| 書誌情報 |
en : Nagoya Journal of Medical Science 巻 69, 号 1-2, p. 9-16, 発行日 2007-01 |
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| フォーマット | ||||||
| 値 | application/pdf | |||||
| 著者版フラグ | ||||||
| 値 | publisher | |||||
| URI | ||||||
| 識別子 | http://hdl.handle.net/2237/7473 | |||||
| 識別子タイプ | HDL | |||||
