Qualification studies are used to determine method performance capabilities for parameters such as specificity, linearity, accuracy and precision as 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 parameters essential to ensure the acceptability of the performance of a bioanalytical method are accuracy, precision, selectivity, sensitivity, reproducibility and stability. The stability of the analyte in biological matrix at intended storage and operating conditions should be established. 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.