4.2. Validation Criteria
The main validation criteria widely recommended by various regulatory documents (ICH, FDA, European Union) and commonly used in analytical laboratories are:
Specificity-selectivity.
Response function (calibration curve).
Linearity.
Precision (repeatability and intermediate precision).
Accuracy (trueness).
Measurement error (total error).
Limit of detection (LOD).
Limit of quantification (LOQ).
Assay range.
Sensitivity.
In addition, according to the domains concerned, other specific criteria can be required:
Analyte stability.
Recovery.
Effect of the dilution.
A full validation is necessary for an analytical procedure to pass from the development phase to the phase of routine analysis. The validation step is not only necessary but ...
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