Bioequivalence and Bioavailability Forum

Hi Smog,

❝ I have a little question regarding the pilot study (2x2x2, 11 subjects). The point estimate for the Cmax was 116.97. CI is: LL 95,28, UL 146,01 in the pilot study. The drug is not HVD.

❝ Is there any sence to go forward with pivotal study in case of such GMR? If so which GMR to use: 0,95 or 1,1697?

Those were wise words from Helmut even though he is quoting some very dubious sources . I am a tiny bit less certain than he is, I must admit; like Helmut I am also leaning towards reformulation. Using a GMR of 0.95 for sample size calculation is functionally -in terms of sample size- exactly the same as using 1/0.95 (=1.053) and that is nicely within your confidence interval and could perhaps be used. Eyeballing it, the chance that the true GMR is 1.053 or better appears smaller than the chance (risk) that the true GMR is completely outside the acceptance range. So chances are not much in your favour, I'd say.
But I am not at all very certain about anything in this case.