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

posted by Helmut Homepage – Vienna, Austria, 2023-02-07 12:30 (529 d 01:38 ago) – Posting: # 23443
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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❝ ❝ FDA is organizing a webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence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, same in-/exclusion criteria (→ similar demographics), 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.

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