non-accuracy and precision validation runs in ICH M10 guideline [Regulatives / Guidelines]

posted by Ohlbe – France, 2023-07-10 11:29 (144 d 11:08 ago) – Posting: # 23666
Views: 1,112

Dear Avinash,

❝ Here does non-accuracy and precision validation runs means all other runs except accuracy and precision runs, which includes selectivity, specificity, matrix effect, carry-over, dilution integrity, stability and reinjection reproducibility?

❝ Please help me to understand what is non-accuracy and precision validation runs?

My interpretation would be: all runs with quantitative assessments in matrix. For these runs, you would have QC samples, used for acceptance of the runs.

Obviously this would not apply to e.g. stock or working solution stability.


Complete thread:

UA Flag
 Admin contact
22,811 posts in 4,783 threads, 1,643 registered users;
38 visitors (0 registered, 38 guests [including 6 identified bots]).
Forum time: 21:37 CET (Europe/Vienna)

Nothing shocks me. I’m a scientist.    Harrison Ford (as Indiana Jones)

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