Reinjection Reproducibility (RR) [Bioanalytics]
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.
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.
Complete thread:
- Reinjection Reproducibility (RR) ksreekanth 2020-07-01 18:49 [Bioanalytics]
- Reinjection Reproducibility (RR) Ohlbe 2020-07-02 18:35
- Reinjection Reproducibility (RR) ksreekanth 2020-07-02 18:48
- Reinjection Reproducibility (RR)xtianbadillo 2020-07-03 03:25
- Reinjection Reproducibility (RR) ksreekanth 2020-07-02 18:48
- Reinjection Reproducibility (RR) Ohlbe 2020-07-02 18:35