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

2014 Fiscal Year Final Research Report

• 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
• 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

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.

Free Research Field

臨床薬理学