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

posted by Shuanghe  – Spain, 2019-09-05 14:38 (774 d 07:29 ago) – Posting: # 20544
Views: 1,731

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:

Activity
 Admin contact
21,737 posts in 4,546 threads, 1,543 registered users;
online 9 (0 registered, 9 guests [including 4 identified bots]).
Forum time: Monday 22:07 CEST (Europe/Vienna)

Law is mind without reason.    Aristotle

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