Not more on IS response variations [Regulatives / Guidelines]

posted by nobody – 2019-11-13 10:06 (351 d 19:24 ago) – Posting: # 20797
Views: 2,743

Not a key opinion leader in this field, but:

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?

If have had cases where different lab people (in the good old days of liquid-liquid extraction, though...) could produce different IS response with absolute same equipment, solutions, protocols to follow. Why bother to much, as long the quality of the method/validation covers that?

Kindest regards, nobody

Complete thread:

Activity
 Admin contact
21,179 posts in 4,414 threads, 1,474 registered users;
online 5 (0 registered, 5 guests [including 2 identified bots]).
Forum time: Friday 05:30 CET (Europe/Vienna)

The idea is to try and give all the information to help others
to judge the value of your contribution;
not just the information that leads to judgment
in one particular direction or another.    Richard Feynman

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