Preliminary simulations [BE/BA News]

posted by ElMaestro  – Denmark, 2022-04-30 21:10 (783 d 04:14 ago) – Posting: # 22946
Views: 5,056

Hi Hötzi,

your post is potentially highly significant.

❝ Is this really the intention? The wider the range in tmax, the more easily products will pass. Counterintuitive.


The intention, as I understand it, was exactly the opposite. It goes completely against all intention, doesn't it?
I think this knowledge, if it holds in confirmatory simulations, should be published quickly and made available to regulators.

I very much hope that regulators will abstain completely from letting pride prevail over the regard for the EU patient. So I hope they will not dismiss the argumentation. For example, I could fear they would dismiss your findings because they don't have a palate for simulations (but note they like simulations well enough when it comes to f2; bootstrapping is a simulation, too).

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,059 posts in 4,841 threads, 1,663 registered users;
31 visitors (0 registered, 31 guests [including 6 identified bots]).
Forum time: 01:24 CEST (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

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