tlast (Common) [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-02-21 16:32 (614 d 03:08 ago) – Posting: # 19961
Views: 5,738

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.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

Complete thread:

Activity
 Admin contact
21,179 posts in 4,414 threads, 1,474 registered users;
online 6 (0 registered, 6 guests [including 5 identified bots]).
Forum time: Tuesday 19:41 CET (Europe/Vienna)

No computer has ever been designed
that is ever aware of what it’s doing;
but most of the time, we aren’t either.    Marvin Minsky

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