CHROMATOGRAPHY, Vol. 34 (2013), No. 3, pp. -141

マイクロドーズ臨床試験のためのLC/MS/MS 高感度測定技術
Highly Sensitive Quantification Using Liquid Chromatography-Tandem Mass Spectrometry for a Microdose Analysis in Clinical Trial

富樫一天¹、牟田口国則¹、山口建¹、小室勢津子¹、山下伸二²
Kazutaka Togashi¹, Kuninori Mutaguchi¹, Takeru Yamaguchi¹, Setsuko Komuro¹, Shinji Yamashita²

¹Pharmaceutical Business Division, Pharmaceutical Analysis Osaka Laboratory, Sumika Chemical Analysis Service, Ltd., 1-135, 3-chome, Kasugade-naka, Konohana-ku, Osaka 554-0022, Japan
²Faculty of Pharmaceutical Sciences, Setsunan University,
45-1, Nagaotoge-cho, Hirakata, Osaka 573-0101, Japan

The objective of microdose (MD) clinical study is to obtain human pharmacokinetics data at earlier phase of drug development, which is more informative than animal data to screen new drug candidates and improve success rate of drug development. Currently the MD study is a new approach for clinical study, which is examined actively in Europe, the USA and Japan. In the MD study, an ultratrace dose of less than one hundredth of the therapeutic dose of drug is administered to human subject, hence it requires the measurement technology with high sensitivity. The purpose of this report is to represent the methodologies of high sensitive quantification by LC/MS/MS (liquid chromatography-tandem mass spectrometry) for a microdose clinical trial and we try to mention about availability for cold MD study using LC/MS/MS analysis.