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

posted by Astea – Russia, 2020-06-05 19:05 (233 d 03:48 ago) – Posting: # 21501
Views: 6,165

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:

Activity
 Admin contact
21,310 posts in 4,445 threads, 1,489 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Sunday 21:54 CET (Europe/Vienna)

Every man gets a narrower and narrower field of knowledge
in which he must be an expert in order to compete with other people.
The specialist knows more and more about less and less
and finally knows everything about nothing.    Konrad Lorenz

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