Survey on the tiered approach for Japanese bioanalysts operated by Japan bioanalysis forum DG2014-09
![](https://www.bioanalysis-zone.com/wp-content/uploads/2015/10/Guidelines-x1280-800x345.jpg)
“...the requirements for analytical method characterization level would depend on the intended purpose and the importance of the data.” 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 day-to-day laboratory works [6,7]. In principle, it complies with the Japanese bioanalytical method validation (BMV) guideline [2], but...