Development of Micro-blood-sampling Method for Pharmacokinetic Analysis in Clinical Studies

Research Project

Project/Area Number	25670070
Research Category	Grant-in-Aid for Challenging Exploratory Research
Allocation Type	Multi-year Fund
Research Field	Medical pharmacy
Research Institution	Chiba University (2014) The University of Tokyo (2013)
Principal Investigator	HISAKA Akihiro 千葉大学, 薬学研究科(研究院), 教授 (80420206)
Project Period (FY)	2013-04-01 – 2015-03-31
Project Status	Completed (Fiscal Year 2014)
Budget Amount *help	¥3,900,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥900,000) Fiscal Year 2014: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000) Fiscal Year 2013: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
Keywords	小児薬用量 / 薬物動態学 / DBS / LC-MS/MS / モデリング / クリアランス / 臨床試験 / 薬物動態 / 生理学的薬物速度論 / 薬物血中濃度
Outline of Final Research Achievements	It is a serious clinical problem that pediatric dosages are not determined based on scientific evidences. The objective of this study is to develop a micro-blood-sampling method which enables pharmacokinetic studies in pediatric populations. At the same time, we pursued reasonable methods for calculation of pediatric dosages. We improved the dried blood spot (DBS) method in which drug concentrations are determined from DBS on a filter paper. Preciseness of the DBS method has been restricted because sampling volume is unstable. We corrected the volume by measuring the concentration of control internal substances. The result indicated that serum drug concentrations can be estimated precisely from 5~20μL of blood by using the developed method.