AOAC SPIFAN Stakeholder Program Meeting Book (March 17, 2021)

4. Linearity/Calibration Fit

X Textual changes to improve clarity X Sentence regarding relative error of back-calculated concentrations was changed to: X “Assessment of heteroscedasticity should be performed; for example, calculation of relative error of back-calculated concentrations” X Footnote added: No specific criterion in SMPR; recommend calibration errors to be <15% along the whole range. Higher calibration error at LLOQ can be accepted (see FDA 2018, Bioanalytical Method Validation, guidance for industry).

5. LOD/LOQ

X Textual changes: wording adapted to definitions for Matrix blank/Technical Reagent Blank X Two footnotes added: X 10 independent analyses: of independently prepared standards, if feasible X Concentration of analyte in Matrix Blank/Technical Reagent Blank to be <10% of the estimated LOQ

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