tlast (Common) [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2019-02-21 16:32 (888 d 05:25 ago) – Posting: # 19961
Views: 6,822

Hello nobody,

» So what is your solution, do you specify in the protocol/SOP that AUC0-tlast is calculated employing tlast common? Any outcries in EU? Did anybody (sponsor/reg) recognize/ask back?

As far as I know, regulators are well aware of the publications of Getz et al. They totally get the idea aired in their papers, but they don't change their views or ask applicants to change practices.
We also need to bear in mind that it is quite common to have time point deviations on late samples, especially if they are ambulatory. Some of those are missing, even.
There is, for practical purposes, not always a crystal clear way we can speak of a meaningful last common time point regardless of how well the trial is planned and executed.

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,590 posts in 4,513 threads, 1,531 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Wednesday 22:58 CEST (Europe/Vienna)

If a man will begin with certainties, he will end in doubts;
but if he will be content to begin with doubts,
he will end in certainties.    Francis Bacon

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