## Hypotheses [Outliers]

Hi Loky do,

in addition to what Mittyri and Dr Gunasakaran wrote, a general remark about confirmatory studies:
1. You state a null hypothesis H0 and an alternative hypothesis H1.
In bioequivalence H0 is inequivalence – which you desire to reject.
2. You state an appropriate statistical method, most commonly the confidence inclusion approach.
3. You perform the study and assess #1 by #2.
The outcome is dichotomous, i.e., either the study passed (H0 rejected) or it failed (H0 not rejected).
What you must not do: The study failed according to the planned conditions and then you change #1 and/or #2 in order to make it pass. That’s the cherry-picking Mittyri was talking about.
In simple terms: The entire $${\small{\alpha=0.05}}$$ was already ‘spent’ in the original analysis. Hence, any ‘alternative’ evaluation will increase the patient’s risk, which is not acceptable.

Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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