Survey on the tiered approach for Japanese bioanalysts operated by Japan bioanalysis forum DG2014-09.

Abstract

Background The tiered approach is a strategy to limitedly characterize an analytical method initially and expand the range of characterization gradually to a full validation as the drug development process proceeds [1–3]. This approach has been discussed in European Bioanalysis Forum (EBF) [1,3] and Global Bioanalysis Consortium (GBC) [4,5] and is considered so beneficial that it enables the flexible use of analytical methods in dayto-day laboratory works [6,7]. In principle, it complies with the Japanese bioanalytical method validation (BMV) guideline [2], but the description in the guideline is not sufficient to put this approach into practice. In Japan, the importance of building a bioanalytical community was recognized in recent years, and the Japan Bioanalysis Forum (JBF) was established in 2011 [8]. As one of its activities, voluntary discussion groups (DGs) were organized in 2013. Under this circumstance, ‘tiered approach to the metabolite quantification’ was adopted as one of the DG topics in 2013 (named DG2013-03). In DG2013-03, analytical tiers raised by GBC were put into a typical workflow of drug discovery and development with consideration of regional practices as reported previously [9,10]. As a subsequent activity, a further survey on the tiered approach for Japanese bioanalysts was performed in a follow-up DG (DG2014-09) in the fiscal year 2014 [11]. Survey on the tiered approach A survey and discussion on following items were performed to facilitate the use of tiered approach in metabolite quantification. Initially, general opinions on tiered approach were collected: