Qualification studies are used to determine method performance capabilities for parameters such as specificity, linearity, accuracy and precision, which are required for an intended application. There are no predetermined method performance specifications, however, there may be minimal method performance capability requirements based on an intended application.
The essential parameters to ensure acceptability of the performance of a bioanalytical method are accuracy, precision, selectivity, sensitivity, reproducibility and stability. The stability of the analyte in a biological matrix at intended storage and operating conditions needs to be evaluated. The matrix-based standard curve should consist of a minimum of five standard points (excluding blanks) using single or replicate samples, and should cover the entire range of expected concentrations.