Precision and accuracy of clinical repeated-dose pharmacokinetic trials applying a peak-and-trough sampling design to estimate oral clearance
| Project/Area Number |
20790130
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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 |
Medical pharmacy
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| Research Institution | University of Toyama |
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Principal Investigator |
TAGUCHI Masato University of Toyama, 大学院・医学薬学研究部(薬学), 講師 (20324056)
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| Project Period (FY) |
2008 – 2009
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| Project Status |
Completed (Fiscal Year 2009)
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| Budget Amount *help |
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2009: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2008: ¥2,860,000 (Direct Cost: ¥2,200,000、Indirect Cost: ¥660,000)
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| Keywords | 臨床薬学 / 薬物動態 / 臨床試験 / 個別投与設計 / 採血デザイン / 2点採血デザイン / 経口クリアランス / 臨床薬物動態試験 / カルベジロール / 心不全 / CYP2D6 |
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| Research Abstract |
The area under the concentration-time curve (AUC) and/or oral clearance (CL/F) of drugs is a key pharmacokinetic parameter to evaluate drug exposure in patients. In the present study, we performed a simulation for the clinical pharmacokinetic study, in which blood was sampled at two time points corresponding to the peak concentration (C_<peak>) and trough concentration (C_<trough>) following repetitive oral drug administration to subjects. The approximate oral clearance (CL/F_<approx>) and/or an alternative oral clearance (CL/F_<exp>) were accurate for hypothetical drugs with varied pharmacokinetic properties. We performed that the peak-and-trough sampling design is promising for the clinical repeated-dose pharmacokinetic trial for drugs.
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Report
(3 results)
Research Products
(41 results)
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[Presentation] 小児肺高血圧患者におけるボセンタンの体内動態変動性評価.2009
Author(s)
田口雅登, 加藤悠也, 堀内威佐男, 橋本征也, 廣野恵一, 伊吹圭二郎, 市田蕗子, 芳村直樹, 秋田千里, 中村常之, 中山智孝, 佐地勉
Organizer
第37回北陸小児肺循環研究会
Place of Presentation
金沢
Year and Date
2009-09-19
Related Report
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[Presentation] 小児肺高血圧患者におけるボセンタンの体内動態解析.2009
Author(s)
田口雅登, 森ゆんい, 堀内威佐男, 橋本征也, 廣野恵一, 上勢敬一郎, 市田蕗子, 芳村直樹, 北岡千佳, 中村常之, 高月晋一, 中山智孝, 佐地勉
Organizer
第15回日本小児肺循環研究会
Place of Presentation
東京
Year and Date
2009-02-07
Related Report
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