Bioequivalence and Bioavailability Forum

❝ Good morning folks of BEBAC,

Good afternoon, Marcel.

❝ Does anyone (...) study (...) bioequivalence (...)un(...)dressed?

❝ Do I make sense?

Yeah, you make a lot of sense, Marcel.

I do recall an innovator getting away with it (late development issue; needed to change something in the CMC and then show eq. to the drug that was tested in the pivotals). My personal opinion is that a drug is bioequivalent if BE is shown, regardless of what's written in the protocol. The drug does not get any better or worse because of a sentence in a protocol somewhere, but this is not always the reasoning of regulators. If this issue hits CMD(h) in a referral I think the chances would be reasonably high for approval. This of course requires that the RMS is willing to approve. So submit it in Sweden?