AUCt not covering at least 80% of AUCinf [Regulatives / Guidelines]

posted by Astea – Russia, 2020-06-05 21:05 (1382 d 16:48 ago) – Posting: # 21501
Views: 12,685

Dear Friends!
I've got I question concerned to this issue.
Until now I thought that the rule of 80% AUCinf was invented in order to demonstrate that the total duration of sampling is sufficient. But consider a following case:
IR drug with T1/2=12-18 hours (according to literature data).
The last sampling time in the protocol was choosen to be 48 hours with a large step before, like: ..8 hours, 12 hours, 24 hours and 48 hours.
For several subjects the PK curves were like this:

[image]
The concentration in the last point was below LLOQ, however AUClast didn't cover 80% of AUCinf.
So I may conclude, although the rule was not followed, the duration of the sampling time was sufficient. In this case the rule may indicate: too large distance between sample time points (48-24=24) that is an error in study planning or too large LLOQ. Am I right in this conclusion? How can regulators interpret this issue?

"Being in minority, even a minority of one, did not make you mad"

Complete thread:

UA Flag
Activity
 Admin contact
22,940 posts in 4,812 threads, 1,640 registered users;
47 visitors (1 registered, 46 guests [including 4 identified bots]).
Forum time: 12:54 CET (Europe/Vienna)

Those people who think they know everything
are a great annoyance to those of us who do.    Isaac Asimov

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