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

“…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...

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