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.
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Characterization: key information for method validation