Outlier in fixed dose combination [Outliers]

posted by yoyo87 – Egypt, 2022-07-21 14:01 (617 d 02:26 ago) – Posting: # 23154
Views: 1,147

Dears

In a BE study of bilayer fixed combination product, one is immediate release and other is sustained, one volunteer in one phase shows no concentrations for the immediate release product (test product) :confused:, while the other sustained active ingredient shows normal concentration profile, all other phases in the volunteer also show regular profile for both actives, no evidence for emesis or any adverse event occurred, what is the probability of this case, could this volunteer be outlier, or its related to the formulation and production? what the suggested solution for this case, that could be accepted by authorities?

Thanks

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
108 visitors (0 registered, 108 guests [including 4 identified bots]).
Forum time: 15:28 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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