Subject non compliance (or product failure?) [Study As­sess­ment]

posted by Loky do – Egypt, 2020-07-16 20:29 (187 d 04:38 ago) – Posting: # 21724
Views: 966

Many Thanks, Helmut for your reply

» ... it is considered acceptable that low-lier profiles can be excluded from statistical analysis […] if they occur with the same or lower frequency in the test product compared to the reference product.
» (my emphases)

Is this case-specific for this product, and its formula? or it could be followed for other products with the same cases?

thanks in advance:-)

Complete thread:

Activity
 Admin contact
21,306 posts in 4,443 threads, 1,488 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Wednesday 01:08 UTC (Europe/Vienna)

Power: That which is wielded by the priesthood of
clinical trials, the statisticians, and a stick which they use
to beta their colleagues.    Stephen Senn

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