Proposed changes [Two-Stage / GS Designs]

posted by Mauricio Sampaio  – Brazil, 2020-02-17 13:50 (824 d 18:51 ago) – Posting: # 21177
Views: 4,406

» 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:

UA Flag
Activity
 Admin contact
22,091 posts in 4,630 threads, 1,566 registered users;
online 6 (0 registered, 6 guests [including 5 identified bots]).
Forum time: Sunday 09:42 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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