ULOQ [Study As­sess­ment]

posted by Ohlbe – France, 2017-10-30 15:10 (989 d 23:18 ago) – Posting: # 17953
Views: 6,239

Hi Helmut,

» Let’s assume that the subject with concentrations >ULOQ is observed in the last batch and we are already close to the validated long-term stability. Even if we revalidate with a higher dilution, we may exhaust the storage interval – resulting in unacceptable results as well. In such a case we have to exclude the subject.

If the storage interval is limited by the duration studied during validation (e.g. stability demonstrated for 30 days, still fine at the end): I would extend the validated period (always keep some extra stability samples in the freezer, just in case !). If the stab failed at the last time point: indeed in trouble. But I think that regulators would not see with a very positive eye the exclusion of the one subject with the highest Cmax in the whole study. Particularly if his Cmax was within range in the other period.

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
20,859 posts in 4,361 threads, 1,451 registered users;
online 30 (1 registered, 29 guests [including 20 identified bots]).
Forum time: 15:29 CEST (Europe/Vienna)

The interpretation of facts in a certain way
stimulates other scientists’ thoughts.    Róbert Bárány

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