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

posted by ElMaestro  – Denmark, 2019-11-13 18:35 (1566 d 19:59 ago) – Posting: # 20799
Views: 3,808

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?

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
22,912 posts in 4,806 threads, 1,635 registered users;
26 visitors (0 registered, 26 guests [including 5 identified bots]).
Forum time: 14:34 CET (Europe/Vienna)

It is the peculiar and perpetual error of the human understanding
to be more moved and excited by affirmatives than negatives.    Francis Bacon

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