Terms & Definitions • 374 scientific validation


To provide concentration data that are scientifically accurate, reproducible and traceable to allow valid decision-making for the intended purpose of the study and that can withstand independent review (and, although not following regulated guideline “standard operating procedure (SOP)”, also review from regulators if so required). Within scientific validation, the following tiers can be defined: “stage-appropriate scientific validation” or “assay-appropriate scientific validation”. Sometimes referred to as “fit-for-purpose” validation.


• 375 selected reaction monitoring (SRM)


The most selective tandem quadrupole operating mode and ideal for quantitative applications. Precursor ions are isolated then collision- activated dissociation of the precursor occurs, with product ion isolation completing the process.


• 376 selectivity


The ability of the bioanalytical method to measure and differentiate the analytes in the presence of components that may be expected to be present. These components are generally structurally related to the analyte and could include metabolites, impurities, degradants or matrix components.


• 377 sensitivity


The lowest analyte concentration that can be measured above the noise with acceptable accuracy and precision (i.e., lower limit of quantification [LLOQ]). An alternative and statistical definition is the slope of the concentration-response calibration curve at any given point on the curve.


• 378 serum


The liquid that is obtained after clotting of the blood and subsequent centrifugation.


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