Not more on IS response variations [Regulatives / Guidelines]

posted by nobody – 2019-11-13 10:06  – Posting: # 20797
Views: 1,205

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
20,251 posts in 4,262 threads, 1,398 registered users;
online 10 (0 registered, 10 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 14:05 CET

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

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