Hey wait a moment.... [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2018-06-27 06:29 (882 d 12:49 ago) – Posting: # 18972
Views: 8,762

Good morning Hötzi,

» Good point – I missed that! In the past I did not adjust because only one will be marketed (i.e., the entire patient’s risk lies with this product). However, some regulatory statisticians (you know, coffee break chats) seem to be more strict because one gets two chances of passing. Too lazy to crawl the supplementary material of your paper about pilot studies: Is such a case covered?

Whose paper? :-D:-D:-D Some crackpot had one published paper and it covered the case of one product being tested in a pilot, then in a pivotal trial, depending on the figures. Rumours have it he is working on another manuscript dealing with scenarios like the one in this thread and that reviewers are way too tough. But then again, you cannot always trust rumours. Only trust google and wikipedia. :-)


Hi all,

ok you'll think that I am nuts, but I think I will need to put it into reverse here:

Let us say both R1 and R2 are (truly) not BE. For simplicity think of them as products with the exact same properties even though they formally may be called something different. Since we are happy if we approve one of them, applying alpha=5% could inflate the type I error (approval of a non-BE product) if the true relative performances are around the acceptance borders.

We need that alpha correction. Sorry.


Edit: Two posts merged. [Helmut]

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

Complete thread:

Activity
 Admin contact
21,210 posts in 4,426 threads, 1,481 registered users;
online 10 (0 registered, 10 guests [including 6 identified bots]).
Forum time: Wednesday 19:19 UTC (Europe/Vienna)

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

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