Proposed changes [Two-Stage / GS Designs]

posted by Mauricio Sampaio  – Brazil, 2020-02-17 13:50 (529 d 13:03 ago) – Posting: # 21177
Views: 3,762

» Consequences for the Consulta Pública N° 760.

Instead of: "Type I error must be preserved and adjusted, and to demonstrate bioequivalence the level of confidence is 94.12%;"

I will only propose that: It must be demonstrated that the type I error of the study is controlled.

Instead of: "This second group must have at least 50% of the previous group"

I will propose that: The number of participants in the second stage must be calculated based on the data extracted from the first stage. The calculation must be justified considering possible losses and / or dropouts observed in the first stage.

In this way, the dialogue is open and not restricted. = "on top of the wall"

[image]


Edit: Subject line changed; see also this post #2. [Helmut]

Complete thread:

Activity
 Admin contact
21,594 posts in 4,515 threads, 1,532 registered users;
online 10 (0 registered, 10 guests [including 4 identified bots]).
Forum time: Saturday 03:54 CEST (Europe/Vienna)

Restlessness is discontent –
and discontent is the first necessity of progress.
Show me a thoroughly satisfied man 
and I will show you a failure.    Thomas Alva Edison

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