Reinjection Reproducibility (RR) [Bioanalytics]

posted by xtianbadillo – Mexico, 2020-07-03 03:25 (110 d 06:41 ago) – Posting: # 21640
Views: 1,028

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.

Complete thread:

 Admin contact
21,171 posts in 4,412 threads, 1,475 registered users;
online 12 (1 registered, 11 guests [including 3 identified bots]).
Forum time: Wednesday 10:06 CEST (Europe/Vienna)

But it is in matters beyond the limits of mere rule
that the skill of the analyst is evinced.
He makes in silence a host of observations and inferences…    Edgar Allan Poe

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz