量研学術機関リポジトリ「QST-Repository」は、国立研究開発法人 量子科学技術研究開発機構に所属する職員等が生み出した学術成果（学会誌発表論文、学会発表、研究開発報告書、特許等）を集積しインターネット上で広く公開するサービスです。 Welcome to QST-Repository where we accumulates and discloses the academic research results(Journal Publications, Conference presentation, Research and Development Report, Patent, etc.) of the members of National Institutes for Quantum Science and Technology.
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This is a report proposing draft guidance on exploratory investigational new drug (E-IND) clinical trials, except microdosing clinical trials, to succeed and complete the report on the proposed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Based on our previous report, MHLW formally issued the draft guidance on microdosing clinical trials, on 28 December 2007 in order tp receive public comments. Considering this draft guidance, we discussed the differences between microdosing but lower than used in traditional phase 1 clinical trials.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.
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)
