422. 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.
423. selected reaction monitoring (SRM) The most selective tandem quadrupole operating mode and well adapted for quantitative applications. Precursor ions are isolated and collision-activated dissociation of the precursor occurs, with product ion isolation completing the process.
424. 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.
