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 the report of the findings from foreign site visits and a literature survey on the trend concerning microdosing and PET molecular imaging clinical trials in United States, United Kingdom, and Sweden, as the part of the study project"Innovative Strategies for Drug Development using Microdosing Clinical Studies (NEDO Microdose-PJ, Fiscal Year 2008-2010)", led by Prof Yuichi Sugiyama, University of Tokyo, sponsored by the New Energy and Industrial Technology Development Organization (NEDO).
The objective of this project is to find some factors to affect consistency between microdosing and therapeutic dosing and to develop methods of quantitative prediction on absorption, distribution, metabolism, excretion (ADME), through the newly developing analytical technologies such as AMS (Accelerator Mass Spectrometry), LC/MS/MS (Liquid Chromatograph/Mass Spectrometry/ Mass Spectrometry) and PET (Positron Emission Tomography) molecular imaging.
In order to translate scientific results into actual utilization in Japanese drug companies' clinical development process, surveys on the situation in the United States and Europe concerning these methodologies have been conducted in addition to experimental studies both in laboratories and clinical sites in Japan.
Main findings from this survey are that the scientific research level is almost the same among Japan, United States, and Europe, but the development of regulatory frameworks and collaborative initiatives among regulatory authorities, industries, and academia are more plentiful especially in the United States and also in Europe. In Japan, efforts to develop a regulatory framework and collaborative initiatives among the three parties would be critical for utilization of such newly emerging technologies as microdosing and PET molecular imaging for clinical pharmaceutical development.
マイクロドーズおよびPET分子イメージング臨床試験に関する海外動向調査 米国・英国・スウェーデン調査から（NEDO MicroDose-PJ）
