Bioequivalence and Bioavailability Forum

Hi Ravi,

I agree with HS, but you may have an ace up your sleeve still:
There is one point on the curve that is known much better than any other point, and thats the one corresponding to a zero dose when Cmax or AUC is zero (we not talking endogenous compounds, right?).

So if your curve for linearity, when extraploted backwards, goes through (0,0) with overwhelming certainty*, then you have a rather strong argument for linearity in the region 0 - 3 which I guess is what you need. It may well be accepted by regulators.


Best regards
EM.

*: No principles here. Fight for it with your own arguments.