Bioequivalence and Bioavailability Forum

Dear all,

I think this was an interesting question, and I agree with the two responders. But I wonder about a thing:

Let's assume that there is an interference between OTC-drug/contraceptive X and the analyte Y. That means that the subjects subjected to X will have measurements of Y that are wrong (or more wrong than they would be in the absence of X).
In this situation, who runs the risk, the sponsor or the patient?

In BE-studies randomisations are always used, which means the patients subject to factor X will be 'equally' (on average) partitioned into the two sequences. That's one headache eliminated. If we assume the interference is equal in the two periods, the interference should have equal effects on T and R provided that T and R are actually equivalent. So, this interference will just translate into higher variability. Sponsor's risk, I guess.
However, I am not able to convince myself that this is also so when T and R are not actually equivalent, as interferences between X and Y typically show a bit of dependence on the amounts of both.

Am I wrong?

Thank you.
EM.