Analytical method transfer using equivalence tests with reasonable acceptance criteria and appropriate effort: Extension of the ISPE concept

Transfer of high performance liquid chromatography with diode array detection method for determination in serum of psychotropic drugs

“…The objective of this study was to transfer to LADAMET an HPLC analytical method coupled to a Diode Array Detection (HPLC/DAD) used in the Laboratory of Clinical, Forensic, Environmental and Industrial Toxicology, University Hospital-Liege. The analytical method transfer (AMT) consists in transferring an analytical procedure from a laboratory, where it was originally developed and validated or where it is in routine use (sender), to a new laboratory (receiver) for its application in routine (Fontenay, 2008;Dewé et al, 2007;Kaminski, Schepers, & Wätzig, 2010). The purpose of AMT is to qualify the receiver to use the analytical procedure.…”

Design and Statistical Analysis of Method Transfer Studies for Biotechnology Products

“…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].…”

“…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.…”

“…With regard to statistical analysis methods, although it has been commonly accepted that the significance test should be avoided for the comparative data in method transfer studies, several statistical analysis approaches, including the equivalence test, tolerance interval method and total error method [3,6,[8][9][10][11]13] have been proposed. However, these proposals did not discuss on how to establish the acceptance criteria.…”