Inflation of the TIE as well [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-01-29 16:38 (1771 d 08:50 ago) – Posting: # 21095
Views: 25,727

Hi Elena,

you are modifying the common decision scheme. Why?
Since you are making essentially the same decisions though in a different order, you gain nothing.

❝ And another question: is this obligatory to include the detailed description of null and alternative hypotheses for Cmax (ABEL) and AUCt (ABE) together with description of conditions that lead to acceptance/rejection of a hypothesis in a protocol of a full replicate study?


Well, that’s the problem with ABEL (and the FDA’s RSABE as well). There is no Null Hypothesis. Before you assess the data you have no clue which path(s) of the framework you will follow. You can – and should – only describe the procedure.

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
23,332 posts in 4,899 threads, 1,660 registered users;
20 visitors (0 registered, 20 guests [including 10 identified bots]).
Forum time: 01:29 CET (Europe/Vienna)

I don’t write drafts.
I write from the beginning to the end,
and when it’s finished, it’s done.    Clifford Geertz

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