“Forced BE” 101 [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2017-12-27 12:23  – Posting: # 18097
Views: 23,012

» what about regulatory queries on "unintentional forced Bioequivalence"

What do you mean by unintentional?
Again: Stop estimating post hoc power! Either the study demonstrated BE or not.*
Going back to my example (study planned for 90% power): The chance to obtain a post hoc power of ≥95% is ~35%. Now what?
It only means thatHowever, the patient’s risk (α = probability of the Type I Error) is independent from the producer’s risk (β = probability of the Type II Error). The latter might be of concern for the IEC in study planning (see Yura’s example) whereas only the former is of regulatory concern – and not affected by power.

I still think that you calculations are wrong. Therefore, you are facing high values more often. Would you mind giving us the data ElMaestro and I asked for?



Cheers,
Helmut Schütz
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