@article{oai:repo.qst.go.jp:00057522,
 author = {杉山, 雄一 and 馬屋原, 宏 and 池田, 敏彦 and 矢野, 恒夫 and 須原, 哲也 and 栗原, 千絵子 and 海野, 隆 and 加藤, 基浩 and 大塚, 峯三 and 伊藤, 勝彦 and 残華, 淳彦 and 檜山, 行雄 and 戸塚, 善三郎 and 西村, 伸太郎 and 渡辺, 恭良 and 熊谷, 雄治 and 藤原, 博明 and 杉山 雄一 and 須原 哲也 and 渡辺 恭良},
 issue = {3},
 journal = {臨床評価},
 month = {Jun},
 note = {This is a report proposing draft guidance on exploratory investigational new drug (E-IND) clinical trials, except microdosing clinical trials, to succeed and complete the report on the proposed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 Based on our previous report, MHLW formally issued the draft guidance on microdosing clinical trials, on 28 December 2007 in order tp receive public comments. Considering this draft guidance, we discussed the differences between microdosing but lower than used in traditional phase 1 clinical trials.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.},
 pages = {633--650},
 title = {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)},
 volume = {35},
 year = {2008}
}