@misc{oai:repo.qst.go.jp:00064053,
 author = {Kurihara, Chieko and Fukushima, Yoshiko and Hirata, Tomoko and Takizawa, Sachie and Takeguchi, Eriko and Sugiyama, Yuichi and 栗原 千絵子 and 福島 芳子},
 month = {Oct},
 note = {INNOVATIVE STRATEDIES FOR DRUG DEVELOPMENT USING MICRODOSING CLINICAL STUDIES (NEDO MICRODOSE-PJ) 2010 (1) - INTERNATINAL COMPARISON OF REGULATORY DOCUMENTS CONCERNING MICRODOSE CLINICAL TRIAL
Chieko Kurihara1, Yoshiko Fukushima1, Tomoko Hirara2 , Sachie Takizawa2, Eriko Takeguchi2, and Yuichi Sugiyama3
1 National Institute of Radiological Sciences, Anagawa 4-9-1, Inage, Chiba 263-8555, Japan,
2 NEDO Project Office, Association for Promoting Drug Development, c/o Graduate School of Pharmaceutical Sciences, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-0033, Japan and
3 Graduate School of Pharmaceutical Sciences, Tokyo University, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
[Purpose] To identify differences of regulatory policies concerning microdose clinical trial (MD) and people's interpretation of policy documents and scientific data, among United States (US), European Union (EU) and Japan, through the policy development process until the consensus at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use -M3 guidelines on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH-M3) and to find the points for which Japanese policy statements and scientific interpretation are desired to be clarified.
[Methods] Literature review and interview survay in US, EU and Japan, concerning science and regulations on MD.
[Results and Discussion] The people in US and EU tend to regard that after ICH-M3 the previous related guidance documents on non clinical studies requirements for MD are replaced by ICH-M3, on the other hand, Japanese people don't tend to regard as well, so for them it is not clear whether radiation dose estimation study is required for MD because it is required in the previous guidance but not required in the ICH-M3.
[Conclusions] Japanese policy should be made clear whether radiation dose estimation study is required for MD.
[Acknowledgement] This and the following 14 studies are sponsored by the New Energy and Industrial Technology Development Organization (NEDO)., 第25回日本薬物動態学会年会},
 title = {INNOVATIVE STRATEDIES FOR DRUG DEVELOPMENT USING MICRODOSING CLINICAL STUDIES (NEDO MICRODOSE-PJ) 2010 (1) - INTERNATINAL COMPARISON OF REGULATORY DOCUMENTS CONCERNING MICRODOSE CLINICAL TRIAL},
 year = {2010}
}