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

posted by Shuanghe  – Spain, 2019-09-05 14:38  – Posting: # 20544
Views: 504

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
20,134 posts in 4,245 threads, 1,386 registered users;
online 37 (0 registered, 37 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 12:40 CET

A Camel is a Horse designed by committee.    Anonymous

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