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早期探索的臨床試験(マイクロドーズ試験を除く)実施に関する指針(草案)
https://repo.qst.go.jp/records/57522
https://repo.qst.go.jp/records/5752265f03765-4283-41b4-adab-4dab7981b1ee
| Item type | 一般雑誌記事 / Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2009-01-07 | |||||
| タイトル | ||||||
| タイトル | 早期探索的臨床試験(マイクロドーズ試験を除く)実施に関する指針(草案) | |||||
| 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 |
杉山, 雄一
× 杉山, 雄一× 馬屋原, 宏× 池田, 敏彦× 矢野, 恒夫× 須原, 哲也× 栗原, 千絵子× 海野, 隆× 加藤, 基浩× 大塚, 峯三× 伊藤, 勝彦× 残華, 淳彦× 檜山, 行雄× 戸塚, 善三郎× 西村, 伸太郎× 渡辺, 恭良× 熊谷, 雄治× 藤原, 博明× 杉山 雄一× 須原 哲也× 渡辺 恭良 |
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| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | This is a report proposing draft guidance on exploratory investigational new drug (E-IND) clinical trials, except microdosing clinical trials, to succeed and complete the report on the proposed guidance on E-IND, focussing on microdosing, nad published in the May 2007 issue of Clinical Evaluation. Both of these reports were drafted by a committee led by Yuichi Sugiyama of the Association for Promoting Drug Development(APDD), commissioned by Yasuo Ohno, head of the MHLW(Ministry of Health, Labor and Welfare) task force study group on this subject. The committee took on the work on this subject by the "Microdosing & E-IND Study Group", a private group led by Sugiyama. Based on our previous report, MHLW formally issued the draft guidance on microdosing clinical trials, on 28 December 2007 in order tp receive public comments. Considering this draft guidance, we discussed the differences between microdosing but lower than used in traditional phase 1 clinical trials. Considering also the discussion at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), we proposed two types of E-INDs: (1)subtherapeutic, single-dose; (2)therapeutic, single ore repeat dose, and described the scientific considerations for each in view of dose setting; necessary pre-clinical data; manufacturing; radioactive protection of human subjects; etc.. We hope this report will contribute to further discussions on the development of regulatory guidance, and become an effective tool for successful drug development. |
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| 書誌情報 |
臨床評価 巻 35, 号 3, p. 633-650, 発行日 2008-06 |
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| ISSN | ||||||
| 収録物識別子タイプ | ISSN | |||||
| 収録物識別子 | 0300-3051 | |||||
