Publication / Source: Bioanalysis 8(2)
Authors: Makoto Niwa, Nozomu Koseki, Yoshitaka Hashimoto et. al
“…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 , but the description in the guideline is not sufficient to put this approach into practice.