Bioequivalence and Bioavailability Forum

Hi ElMaestro,

THX for your elaborate answer.

❝ […] and I could very well have misunderstood you due to my walnut-sized brain […]

For sure my confusion is caused by my peanut-sized brain. The GL states

The statistical analysis should take into account sources of variation that can be reasonably [sic] assumed to have an effect on the response variable.

Think about my example (forget about Xovers now; see also this one). Even in large centers we might have more than one group per treatment due to difficult recruitment. What if one group shows only ⅛ of the ‘normal’ response? We know that handling and storage of samples in University hospitals might not be that well-controlled like in spezialised CROs… Can/should we pool the data in such a case? Not only the CV will be inflated, the treatment effect will be biased as well. Referring to the – canceled – presentation above it seems to me that the BfArM is concerned about “group and centre effects”.

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P.S.: Any idea why I get unequal variances of T and R in ~28% of studies? I expect only ~5%…