Log in
RegisterReformulate… [Study Assessment]
posted by Helmut 
– Vienna, Austria, 2021-02-15 11:59 (1606 d 04:08 ago) – Posting: # 22209
Views: 2,645
Hi Ibrahim,
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.
❝ 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!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Bioequivalence study of Glimepride Tablet Ibrahim Komeil 2021-02-15 10:07 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Reformulate…Helmut 2021-02-15 10:59
- Reformulate… Ibrahim Komeil 2021-02-15 23:48
- Reformulate…Helmut 2021-02-15 10:59
Ing. Helmut Schütz