3. Characterization: key information for method validation

The main features are :

• repeatability ;

• reproducibility (or intermediate fidelity) ;

• FITNESS;

• linearity ;

• sensitivity ;

• selectivity/specificity ;

• detection limit ;

• limit of quantification ;

• robustness.

Not all characteristics are systematically evaluated. A selection is made according to need and the analysis of the measurement process, but two of these characteristics are often present: repeatability and accuracy.