Using total error as decision criterion in analytical method transfer

Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products

“…For example, Dewe et al [9] proposed the total error approach with a β-expectation tolerance interval method, in which a proportion (β) of the new laboratory population is expected to fall within the acceptance limits around the mean estimate of the sending laboratory ([1 -γ]μ s , [1 + γ]μ s ) where μ s is the mean of the sending laboratory, and a risk assessment approach, in which the method transfer is accepted if the probability of having results outside the acceptance limits is less than 1 -β. The performance of this approach depends on the acceptance limits ([1 -γ]μ s , [1 + γ]μ s ) and prespecified β.…”

“…With regard to mean values, most published studies proposed the comparison of the mean difference between two laboratories, while others proposed the comparison of the ratio of the means between two laboratories [9].…”

“…While the US FDA guidance to industry [1,2] and further publications [3][4][5][6][7][8][9][10][11][12][13][14][15] discuss the general principles for the design, analysis and evaluation of method transfer studies, they do not explicitly specify the acceptance criteria by which assay transfers are considered acceptable. Although these general principles apply to the majority of assay transfer studies, depending on the type and the intended purpose of the assays, different statistical analysis methods have been proposed to suit specific needs.…”

“…Samples of commercial production batches are recommended to be used [5,[8][9][10][11][12][13] as testing materials. Samples from at least one batch are recommended to be tested [4,[9][10][11][12].With regard to the study designs, method transfer studies should evaluate the impact of factors including analysts, days, number of runs, equipment (brand and/or model), environment and reagent suppliers on the results obtained in the sending and receiving laboratories, using the same testing materials. Wieling proposed to keep the methods, chemicals, reagents, disposables, glassware, equipment (brand and model) and data reduction as identical as possible [6].…”

“…Lin et al [7] recommended that bioanalytical methods use the incurred samples or a set of QC samples prepared to cover the low, medium and high concentrations in both laboratories. Samples of commercial production batches are recommended to be used [5,[8][9][10][11][12][13] as testing materials. Samples from at least one batch are recommended to be tested [4,[9][10][11][12].…”