Bioequivalence and Bioavailability Forum

Hi all,

I am working with very strange formulators...

Question. Has anyone tried running a BE study with two or 3 lots of a reference product (yes, same country, same product, just a different batch/lot)?
If so, what if the study shows 1) test shows BE to all lots of reference 2)test shows BE to 1 or 2 lots of the reference only but failed the other lot + the failed lot doesn't show BE to the other 2 reference lots.

Now the question. Has anyone filed such study(s) to FDA/EMA/TPD???

I know, I know, waste of money. But then with products such as Procardia XL which fails on its own (I don't think it's HVD but very close if I am correct)... Can one present the argument and end up with an "acceptable" reply from the agency?

Personally I think it's feasible. Does it happen in real life? I dunno.

John