(763 d 16:07 ago)
Posting: # 22208
I hope you are all fine
Recently i had got results of bioequivalence study for Glimepride Tablet 1 mg applying two way crossover design with 26 volunteers
The results are shown below:
Cmax: PI = 0.75, 90% CI [0.672 - 0.845]
AUCt: PI = 0.82, 90% CI [0.754 - 1.042]
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.
Thank you in advance
Edit: Category changed; see also this post #1. [Helmut]
(763 d 15:16 ago)
@ Ibrahim Komeil
Posting: # 22209
❝ 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 🖖🏼 Довге життя Україна!
The quality of responses received is directly proportional to the quality of the question asked. 🚮
(763 d 02:26 ago)
Posting: # 22210
Thank you very much for your reply
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]