Bioequivalence and Bioavailability Forum

Dear all,

I cross-checked the L. Endrenyi/L Tothfalusi chapter in Kanfer/Shargel’s book “Generic Drug Product Development” and found a difference to the code provided by FDA for Progesterone:
The so called “x” (=PE²-SE²) in the Progesterone BE recommendation does not resemble the Em (=PE²) which would be necessary to have the identical formula for the Confidence limit calculation:

CL = Em-Es + √(Lm+Ls) acc. to your Kanfer/Shargel Chapter

I tried now to simulate data in EXCEL to find out, which one is correct and calculated a “third” way of concluding BE: simply the exponentiated CI for the difference of the means using the SE of the differences.

Instead of solving the problem, I have now 3 (slightly) differing results; This might be due to simple programming mistake but I couldn’t find them up to now;

1) Does anyone know, if there is a(nother) mistake in the FDA recommendation (the “x” as described above)?

Thanks a lot

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Edit: Category changed. [Helmut]