Clinical pharmacokinetic trials using limited sampling design and robust data analysis
| Project/Area Number |
21590152
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Medical pharmacy
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| Research Institution | University of Toyama |
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Principal Investigator |
HASHIMOTO Yukiya 富山大学, 大学院・医学薬学研究部(薬学), 教授 (90228429)
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| Co-Investigator(Kenkyū-buntansha) |
NOZAWA Takashi 富山大学, 大学院・医学薬学研究部(医学), 准教授 (00180737)
ICHIDA Fukiko 富山大学, 大学院・医学薬学研究部(医学), 准教授 (30223100)
TAGUCHI Masato 富山大学, 大学院・医学薬学研究部(医学), 准教授 (20324056)
ISHIDA Kazuya 富山大学, 大学院・医学薬学研究部(医学), 助教 (90550509)
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| Project Period (FY) |
2009 – 2011
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| Project Status |
Completed (Fiscal Year 2011)
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| Budget Amount *help |
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2011: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2010: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2009: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
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| Keywords | 採血デザイン / 臨床薬物動態試験 |
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| Research Abstract |
Evaluation of the relationship between pharmacological effect and blood concentration of the drug and investigation of the mechanisms for interindividual variability of the pharmacokinetics of the drug are needed to optimize the drug therapy for patients. Recently, we have clarified that the 3 step analysis is useful method to analyze the limited number of patients and/or data in the exploratory clinical trials. In the present study, we verified whether 3 step data analysis is useful to evaluate the pharmacokinetics of the drug in small or medium scale clinical trials
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Report
(4 results)
Research Products
(50 results)
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[Journal Article] Pharmacokinetics of bosentan in routinely treated Japanese pediatric patients with pulmonary arterial hypertension2011
Author(s)
Taguchi M, Ichida F, Hirono K, Miyawaki T, Yoshimura N, Nakamura T, Akita C, Nakayama T, Saji T, Kato Y, Horiuchi I, and Hashimoto Y
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Journal Title
Drug Metab. Pharmacokinet.
Volume: 26
Pages: 280-27
NAID
Related Report
Peer Reviewed
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[Presentation] Optimal limited sampling designs to estimate maximal concentration and area under the curve of mizoribine in pediatric patients with renal disease2010
Author(s)
Ishida K, Takaai M, Uemura O, Nagai T, Satomura K, Kaneda H, Ohta K, Fujieda M, Wada N, Goto Y, Morooka M, and Hashimoto Y
Organizer
Pharmaceutical Sciences World Congress 2010
Place of Presentation
New Orleans
Related Report
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[Presentation] 小児腎疾患患者におけるミゾリビンのAUCとC_<max>予測のための最適少数採血デザインの評価2010
Author(s)
石田和也,鷹合麻里,上村治,永井琢人,里村憲一,金田尚,太田和秀,藤枝幹也,和田尚弘,後藤芳充,諸岡正史,橋本征也
Organizer
第45回日本小児腎臓病学会学術集会
Place of Presentation
大阪
Related Report
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[Presentation] 小児腎疾患患者におけるミゾリビンの最適少数採血デザインの評価2010
Author(s)
石田和也,鷹合麻里,上村治,永井琢人,里村憲一,金田尚,太田和秀,藤枝幹也,和田尚弘,後藤芳充,諸岡正史,橋本征也
Organizer
医療薬学フォーラム2010
Place of Presentation
広島
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
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