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  1. C100 医学部/医学系研究科
  2. C100b 紀要
  3. Nagoya journal of medical science
  4. 69(1-2)

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.69.1-2.9
c874a00a-9fe3-4a53-954d-8ed5c9190b1d
名前 / ファイル ライセンス アクション
p009-016.pdf p009-016.pdf (181.8 kB)
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
著者 Sakamoto, Junichi

× Sakamoto, Junichi

WEKO 15590

Sakamoto, Junichi

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Morita, Satoshi

× Morita, Satoshi

WEKO 15591

Morita, Satoshi

Search repository
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 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.
内容記述タイプ Abstract
出版者
出版者 Nagoya University School of Medicine
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
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 ISSN
収録物識別子 0027-7622
書誌情報 Nagoya Journal of Medical Science

巻 69, 号 1-2, p. 9-16, 発行日 2007-01
フォーマット
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
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