Reformulate… [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-02-15 10:59 (166 d 15:03 ago) – Posting: # 22209
Views: 526

Hi Ibrahim,

» I am confusing to be sure that the test product is bad, so i am asking your help to know the real cause of these results.

Difficult to guess the ‘real cause’ but repeating the study in a larger sample size – given the point estimates – is futile. Even if you believe that the result were due to chance and hope that the point estimates will shift to 0.85 you would need hundreds of subjects to show BE with 80% power.
BTW, the CV of AUC (~0.351) is larger than the one of Cmax (~0.245). Possible but uncommon.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 7 (0 registered, 7 guests [including 3 identified bots]).
Forum time: Sunday 03:02 CEST (Europe/Vienna)

Sit down before fact as a little child,
be prepared to give up every conceived notion,
follow humbly wherever and whatever abysses nature leads,
or you will learn nothing.    Thomas Henry Huxley

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