Reinjection Reproducibility (RR) [Bioanalytics]

posted by xtianbadillo – Mexico, 2020-07-03 05:25 (1449 d 15:03 ago) – Posting: # 21640
Views: 3,000

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
Activity
 Admin contact
23,059 posts in 4,841 threads, 1,664 registered users;
32 visitors (0 registered, 32 guests [including 7 identified bots]).
Forum time: 20:29 CEST (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5