Conference Report: 4th Japan Bioanalysis Forum Symposium: Japanese guidelines on bioanalytical method validation and latest discussion within the Japanese bioanalyst community

Abstract

The Japan Bioanalysis Forum (JBF) was established in 2011 as a group for the purpose of discussion on regulated bioanalysis in Japan. The forum has played a prominent role in the development of Japanese bioanalytical method validation guidelines and has supported Japanese Harmonization Team members of the Global Bioanalysis Consortium. At the 4th JBF Symposium, the outline of the bioanalytical method validation guideline for small molecules in Japan, which was just published in July 2013, and that of the JBF draft guideline for ligand-binding assay, were presented. In addition, the outcomes of discussion groups, in which regulated bioanalysis issues were scientifically discussed, were also presented to about 250 attendees from industry, government and academia.