Summary
In most drug development programs more than one laboratory and/or assay method are used. Often in these cases demonstration of equivalence of data generated by different laboratories/methods is desired in order to prove the consitency of the bioanalytical data throughout the program. Here a scheme is presented for use in inter-laboratory or inter-assay comparison studies. The protocol is divided into two different phases: In the first spiked samples phase an indication of general assay performance and detection of potential major problems is obtained. Thereafter, in the second phase the final comparison is performed using dosed subject samples. Acceptance criteria were derived from standard bioanalytical validation requirements. An advantage of the present, scheme compared to others is that great statistical expertise is not required for its use and understanding.
It has been successfully applied to a number of cross-validation data sets and will be further evaluated in the future.
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References
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Gansser, D. Experience with a cross-validation approach. Chromatographia 55 (Suppl 1), S71–S74 (2002). https://doi.org/10.1007/BF02493356
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DOI: https://doi.org/10.1007/BF02493356