Validation studies for quantitative analytical methods

Validation studies for quantitative analytical methods typically determine some or all of the following parameters:

Precision

The principal precision measures include repeatability standard deviation sr, reproducibility standard deviation sR, (ISO 3534-1) and intermediate precision

Bias

The bias of an analytical method is usually determined by study of relevant reference materials or by spiking studies.

Linearity

Linearity is an important property of methods used to make measurements at a range of concentrations.

Detection Limit

The detection limit is normally determined only to establish the lower end of the practical operating range of a method.

Robustness or ruggedness

the effect of one or more parameter changes is observed

Selectivity/specificity

Typical selectivity studies investigate the effects of likely interferents, usually by adding the potential interferent to both blank and fortified samples and observing the response.

Reference

EURACHEM / CITAC Guide CG 4. Quantifying Uncertainty in Analytical Measurement Second Edition.

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