Bioequivalence and Bioavailability Forum

Hi,

That's all very good, but theory and practice often differ quite a bit.
Typically it is the wish of a generic company to argue for linearity, but data for doing so are not produced by the generic company. In stead values are looked up in the literature (googling stuff is still cheaper than doing a clinical study). And that does more often than not gives 'something' which is difficult to handle.
Perhaps, if you are really lucky, you find 4 or 5 data points for AUC as function of dose.
So let me therefore ask: Given 4 or 5 points of AUC as function of Cmax, what criteria would you evaluate in order to argue for or against linearity?
R squared in my opinion is rather useless here. Agreed you get a 'free' point (0,0) - that in fact is the only point that will be known with certainty for exogenous molecules. But still you are not really in the comfort zone, are you?!

EM.