Clinical pharmacokinetic trials in pediatric patients based on a peak-and-trough sampling design
| Project/Area Number |
22790149
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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 富山大学, 大学院・医学薬学研究部(薬学), 准教授 (20324056)
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| Project Period (FY) |
2010 – 2011
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| Project Status |
Completed (Fiscal Year 2011)
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| Budget Amount *help |
¥3,900,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥900,000)
Fiscal Year 2011: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2010: ¥2,600,000 (Direct Cost: ¥2,000,000、Indirect Cost: ¥600,000)
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| Keywords | 医療薬剤学 / 採血デザイン / 臨床薬物動態試験 / 小児 |
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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 conducted a clinical trial to evaluate the pharmacokinetics of bosentan in Japanese pediatric patients. Plasma samples were taken twice at two time points corresponding to the peak concentration(C_<peak>) and trough concentration(C_<trough>) following repetitive oral drug administration to the petients. A large interindividual variability was observed in plasma concentrations of bosentan, and the weight-normalized values of CL/F were correlated negatively with age. We confirmed 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
(27 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: 280-287
NAID
Related Report
Peer Reviewed
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[Presentation] The pharmacokinetics of bosentan in routinely treated Japanese pediatric patients with pulmonary arterial hypertension2010
Author(s)
Taguchi M., Ichida F., Hirono K., Yoshimura N., Nakamura T., Akita C., Nakayama T., Saji T., Kato Y., Horiuchi I., Hashimoto Y.
Organizer
第46回日本小児循環器学会学術集会
Place of Presentation
千葉
Related Report
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