Review

リガンド結合法を用いた生体試料中薬物濃度分析法に関するガイドラインの策定状況
Current Status of Development of the Guideline on Bioanalytical Method Validation Using Ligand Binding Assay

石井明子
Akiko Ishii-Watabe

Division of biological chemistry and biologicals, National Institute of Health Sciences 1-18-1 kamiyoga, setagaya-ku, Tokyo 158-8501, Japan

Abstract:

Ligand binding assay (LBA) is a method for detecting an analyte using binding reagents such as antibodies against an analyte. Currently, LBA is used as a standard method for the bioanalysis of therapeutic peptides or proteins. In this review, the principle and examples of LBAs used for bioanalysis as well as the reason why LBA is used as a standard method for large molecule bioanalysis is described. In addition, current situation of the development of Japanese bioanalytical method validation guideline for LBA is mentioned. This review is based on of the presentation at the 20^th Chromatography symposium workshop held in Kobe in June 5^th 2013.

Keywords: Ligand Binding Assay, Bioanalytical Method Validation, Guideline.

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