Bioequivalence and Bioavailability Forum

Hi John,

❝ ❝ From the above parameters, calculate the final 95% upper confidence bound:

❝ ❝ theta=((log(1.25))/0.25)**2;

❝

❝ From the progesterone FDA guidance Dec 2012. I see different equation for theta:

❝

❝ theta=((log(1.11111))/0.1)**2;

❝

❝ Yours is wrong?

Nope. Maybe you had the warfarin-guidance also open in your reader.

Yours would mean downscaling. In the Dec 2012 revision FDA corrected only the ‘visibility’ (missing lines which were formatted in white on a white background). The formula I gave is still the same (upscaling) like in previous versions. See p.6 for the partial replicate and p.8 for the full replicate.