Reinjection Reproducibility (RR) [Bioanalytics]

posted by xtianbadillo – Mexico, 2020-07-03 03:25 (117 d 10:19 ago) – Posting: # 21640
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Approach 2. “The QC samples are analysed against a calibration curve, obtained from freshly spiked calibration standards, and the obtained concentrations are compared to the nominal concentrations. The mean concentration at each level should be within ±15% of the nominal concentration.” (EMA validaton guidelines "Re-injection of samples can be made in case of instrument failure if reinjection reproducibility and oninjector stability have been demonstrated during validation")

Approach 2. Its equivalent to oninjector stability. So a different approach should be considered.

Approach 1. You can consider an anova with different injections at different times. or, check bias and precision between injections at diferrent times.

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