The quest for assay robustness across the life cycle of a bioanalytical method

The successful validation or qualification of an assay plus incurred sample reproducibility gives the bioanalyst confidence of assay suitability. However, these elements alone do not give the full picture of how reliable an assay may be during routine production use for analysis of unknown study samples. The robustness of an assay can be understood by applying key performance indicators to monitor assay performance pre- and post-transfer between laboratories, plus a cross-validation step during assay transfer. The measurement of assay robustness (beyond the context of cross-validation) should not be considered as yet another regulatory layer, but more as a means for...