Ibrahim Komeil
☆    

Egypt,
2021-02-15 09:07
(17 d 12:04 ago)

Posting: # 22208
Views: 218
 

 Bioequivalence study of Glimepride Tablet [Study As­sess­ment]

Dear All
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]
Helmut
★★★
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Vienna, Austria,
2021-02-15 09:59
(17 d 11:12 ago)

@ Ibrahim Komeil
Posting: # 22209
Views: 195
 

 Reformulate…

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.

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Ibrahim Komeil
☆    

Egypt,
2021-02-15 22:48
(16 d 22:23 ago)

@ Helmut
Posting: # 22210
Views: 162
 

 Reformulate…

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]
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