Development of method for setting the rational and safe initial dose in first in human (FIH) studies.
| Project/Area Number |
15K08110
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical pharmacy
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| Research Institution | Tokyo University of Pharmacy and Life Science |
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Principal Investigator |
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| Project Period (FY) |
2015-04-01 – 2018-03-31
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| Project Status |
Completed (Fiscal Year 2017)
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| Budget Amount *help |
¥3,640,000 (Direct Cost: ¥2,800,000、Indirect Cost: ¥840,000)
Fiscal Year 2017: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2016: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2015: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
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| Keywords | FIH試験 / first in human / 初回投与量 / 医薬品開発 / 用量設定 / 薬物動態学 / 薬力学 / FIH |
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| Outline of Final Research Achievements |
Determining the safe initial dose of investigational drugs in the first in human (FIH) studies is one of the most important steps in clinical trials. Ideally, the initial dose should be low not to cause any harm in humans, while it is expected to be not too low for efficacy. The no observed adverse effects level (NOAEL) based approach was the most frequently used to set initial dose. Also, the minimal anticipated biological effect level (MABEL) based approach was used. However, there have been no reports on rational method for setting the initial dose. In this study, we tried to develop the method for setting the rational and safe initial dose by using target molecular binding occupancy theory.
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Report
(4 results)
Research Products
(2 results)
