According to the ICH Q2(R1) guidelines, the acceptability criteria for precision and accuracy are critical in evaluating the performance of analytical methods. These criteria differ for analytical methods (used primarily for chemical substances) and bioanalytical methods (applied in biological matrices), with analytical methods generally requiring stricter thresholds than bioanalytical methods. The relative standard deviation (RSD) should generally be ≤2%? (For bioanalytical is within ≤15% (or ≤20% for the lower limit of quantitation, LLOQ). And Accuracy? Acceptable recovery is generally within 98-102%?
The eligibility criteria may differ for different analysed objects and research methods. In some cases the acceptance criteria are precisely specified in the regulatory documentation (e.g. for validation of analytical techniques used in conjunction with a comparative dissolution kinetics test), and in some cases (mainly in scientific, exploratory studies) the acceptance criteria are set by the researcher. The researcher also provides a rationale for the chosen range of acceptability criteria based on the nature and characteristics of the sample being analysed, the scientific data and regulations that apply to the analysis.
Accuracy can be analysed at three levels: repeatability, intra-laboratory precision and reproducibility.
Fabiola Carrara
The analytical method validation is to be performed on the samples alongwith its placebo( A placebo is the formulation except active ingredient (API)) where as Bio-Analytical method validation involved blood sample matrix that is plasma is to taken to find out about product equivalent. Both the technique is different and hence sensitivity is also different hence both criteria are different.
Hopefully, It will resolve your query. Feel free to send question if any
Just an addition to what others have already commented:
If there is no strong reason to use the Q2(R1) guideline - do not use it. There is a Q2(R2) guideline which is updated and came in effect in June 2024.
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