Revisions of the PSGLs final [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2023-06-23 15:29 (747 d 19:49 ago) – Posting: # 23612
Views: 9,455

Hi ElMaestro & all,

❝ ❝ 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).


Final revisons of the PSGLs were published yesterday.Practically all comments/suggestions were  ignored  not accepted. The only relevant change is 80.00–125.00% of the reference’s median (from 80.00–120.00%). Good luck in sampling every five minutes. :thumb down:
—
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
23,428 posts in 4,929 threads, 1,685 registered users;
34 visitors (0 registered, 34 guests [including 11 identified bots]).
Forum time: 11:19 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

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