Reformulate… [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-02-15 11:59 (711 d 00:14 ago) – Posting: # 22209
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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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