Bioequivalence and Bioavailability Forum

Hi HS,

❝ Statistically speaking there are just two outcomes. The Null is bioinequivalence, which is either rejected (consumer risk with a probability of α) or not. The “grey zone” is related to the producer’s risk (with a probability of 1–β), which is important in study planning. Post hoc we get only this ‘bad luck’ feeling (in German: dumm gelaufen).

Accept the null hypo or not, yes that dicotomic, but that's not in itself what distinguishes between bioequivalent or bioinequivalent (although it usually is what determines regulatory aceptance of a submited dosssier, but this isn't the situaiton here). A product is in practice one of these two options but weare not able to tell which one if we end up with a CI that has includes areas inside and outside the acceptance range like we saw here.
In perspective, consider the ability to repeat studies. In my experience with regulators they accept repeat of a study when it is inconclusive (or some would say under-powered; but again the joker here is when the PE is outside the acceptance range - I shall not say anything generally about who accepts what in such situations).
I am not afraid of saying the FDAs study here was a little underpowered since it did not tell if the product was equivalent or inequivalent. It showed a tendency, possibly, nothing more than that in my opinion. Despite alpha and beta there is still a chance that the product is BE on basis of FDA's result, cf. the repeat issue.

In a country where every there is a lawyer for every 270 ordinary citizens, I understand why a regulatory agency might wish to safeguard against lawsuits just in case. I would however, be happier to see such reactions based on conclusions rather than trends and tendencies.