Reinjection Reproducibility (RR) [Bioanalytics]

posted by xtianbadillo – Mexico, 2020-07-03 03:25 (813 d 22:16 ago) – Posting: # 21640
Views: 2,000

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:

UA Flag
 Admin contact
22,385 posts in 4,684 threads, 1,594 registered users;
online 11 (0 registered, 11 guests [including 4 identified bots]).
Forum time: Sunday 01:42 CEST (Europe/Vienna)

You really don’t know what you don’t know until you write about it.
Then, everyone knows what you don’t know.    Rod Machado

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