2012 Fiscal Year Final Research Report
Exploring international differences in approved doses of drugs
| Project/Area Number |
21790109
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Single-year Grants |
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| Research Field |
Drug development chemistry
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| Research Institution | The University of Tokyo |
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Principal Investigator |
KUSAMA Makiko 東京大学, 大学院・薬学系研究科, 講師 (80313146)
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| Research Collaborator |
ONO Shunsuke 東京大学, 大学院・薬学系研究科, 准教授 (40345591)
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| Project Period (FY) |
2009 – 2012
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| Keywords | レギュラトリーサイエンス / 評価科学 / 民族差 / 人種差 / 医薬品評価 |
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| Research Abstract |
Japan tended to have lower dose compared to the US, whose doses were similar to that of Europe. Dose differences in Japan and the US could not be accounted for by differences in pharmacokinetics between the two regions. The dose in Japan was more likely to be same to that of the US when non-Japanese firms were the sponsors and when Japanese dose-finding study was not conducted. No relation between dose differences and drug characteristics, such therapeutic class, could be identified. Post-market safety profiles did not show any obvious differences in Japan and the US in spite of dose differences.
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