subject inclusion question in replicate design for ANVISA [RSABE / ABEL]

posted by Shuanghe  – Spain, 2019-09-05 16:38 (1836 d 06:22 ago) – Posting: # 20544
Views: 3,008

Hi Helmut,

❝ ❝ […] the client's statistical consultant commented that only subjects who complete all 4 period (2T+2R) should be included, otherwise, they should be excluded even if they completed 3 period.

❝

❝ IMHO, this doesn’t make sense. See the example in the vignette of replicateBE.


Thanks. That's my thought too so I insisted that the statistical section should be kept unchanged. Hopefully ANVISA will issue their own guideline soon...
—
All the best,
Shuanghe

Complete thread:

UA Flag
Activity
 Admin contact
23,225 posts in 4,879 threads, 1,652 registered users;
34 visitors (0 registered, 34 guests [including 9 identified bots]).
Forum time: 23:01 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

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