the run passes = there is no problem? [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-11-13 17:35  – Posting: # 20799
Views: 991

Hi nobody,

» I like discussions along the line "problem -> solution". So: if the LLOQ is rock solid, the calibration function stable and the QCs don't indicate a problem, why should I take care of day-to-day variations in IS response too much?

Using the same kind of argumentation why would you worry about IS at all then? If the run passes why would IS responses in any way be a worry under any circumstance?
If the purpose of a car is to take you from A to B why would anyone care if it starts making sudden clonking noises?

I could be wrong, but...
Best regards,
ElMaestro

Complete thread:

Activity
 Admin contact
20,142 posts in 4,248 threads, 1,385 registered users;
online 24 (0 registered, 24 guests [including 10 identified bots]).
Forum time (Europe/Vienna): 17:58 CET

Maturity is the capacity to endure uncertainty.    John Finley

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