TRT / RTR Design [RSABE / ABEL]

posted by ElMaestro  – Denmark, 2017-05-04 00:04 (2840 d 00:06 ago) – Posting: # 17303
Views: 9,621

Hi Hötzi,

❝ ❝ "The approach of reference-scaled average BE (RSABE) requires that the reference formulation be measured twice in each subject."

❝ … slipped through my intention. My fault. This statement is – despite the two great authors – wrong.


Not your fault. As a reviewer you are not and will never be responsible for anything authored by others. :ok:

But having said that I think the sentence is OK, only the meaning is a bit out of context. To calculate meaningfully the intra-subject variability for Ref we need subjects in whom it has been measured (at least) twice. That was presumably what the authors tried to remind readers.
The entire issue of rsaBE cannot be approached in the absence of such subjects, and therefore the sentence makes quite some sense.

Blumentopferde :cool:

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,379 posts in 4,913 threads, 1,661 registered users;
251 visitors (0 registered, 251 guests [including 29 identified bots]).
Forum time: 23:11 CET (Europe/Vienna)

Science is what you know.
Philosophy is what you don’t know.    Bertrand Russell

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