Multi-group studies ad nauseam [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2023-02-07 12:30 (52 d 17:10 ago) – Posting: # 23443
Views: 957

Hi Achievwin

❝ ❝ FDA is organizing a webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence

❝ Wishful thinking: I hope they give clear direction (kill once for all) - the annoying center/group effect portion for BE studies conducted in one country and in homogenous population.


[image]Get prepared. Wanjie is a tough discussant.

❝ As many times and on many platforms they mentioned it is irrelevant in BE/ANDA contecxt …


The FDA? Where?

❝ … some academic curiosity folks keep brining this topic and keep the topic alive.


On the the contrary. Not a single publication; only problems with some regulators.
Expecting that groups could differ in their PK responses is beyond – not only my – intellectual reach. Can one reasonably assume that a study performed in the same CRO, quite often groups separated by only a couple of days, samples analyzed with the same bioanalytical method in the same lab, in a cross­over each subject acting as its own reference, have an effect on the response variable‽ Of course, not. IMHO, assuming the opposite is an insult to the mind.

»Λόγον ἔχεις;« »ἔχω.« »τί οὖν οὐ χρᾷ;«
‘Hast thou reason?’ ‘I have.’ ‘Why then makest thou not use of it?’

   — Marcus Aurelius (Meditations. Transl. by Meric Casaubon; 1634: Book 4. XI.)


Remember the FDA’s slogan back in the day?

In God we trust;
all others must bring data.

   — W. Edwards Deming


Easy. See this post.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,559 posts in 4,725 threads, 1,607 registered users;
15 visitors (0 registered, 15 guests [including 8 identified bots]).
Forum time: 06:41 CEST (Europe/Vienna)

The penalty for scientific irrelevance is, of course,
that the statistician’s work is ignored by the scientific community.    George E.P. Box

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