Bioequivalence and Bioavailability Forum

Dear PK,

❝ I correct the code and value also.

❝ I also verify it by FARTSSIE, I got same value from both.

Fine!
But notice that FARTSSIE gives you also a lower widened BE limit.

❝ Now Pls tell me for showing Bioequivalece what criteria I have to apply.

❝ 1. upper scaled BE limit is less then zero

❝ 2. 95%CI is less than upper scaled BE limit (I calculated the 95%CI by normal Average bioequivalence).

You mixed up terms! I strongly suggest you to read the references I mentioned above! See also this thread.

ad 1.: With the formula for the widened BE limits you never get a value <0! Try it.
ad 2.: The 90% CI (calculated as usual/normal) must be contained in the widened BE limits. Tothfalusi et.al. call this "Average bioequivalence with expanding limits (ABEL)". But this is statistically only correct if you know (have the true) value of the intra-individual variability. But you have only an estimate from your data.
The rest of the story, the upper 95% confidence interval of the linearized SABE criterion
   (µT-µR)2-thetaS2*sigma2WR with thetaS=ln(1.25)/sigma0
you must read in the references or in the above mentioned thread, this post of mine. But notice that theta there is theta² here.

❝ In the scaled Average BE, if intra CV is >30 then we have to apply scaled BE approach otherwise we calculate only average bioequivalence?

Yes.

❝ In my calculation for Cmax its shows >30% Intra CV but for AUCt and AUCi its show <30%.

So you have to go with SABE for Cmax only.

❝ this is all for FDA subbmission study.

So eventually you have to go with sigma₀=0.25 according to Haidar et.al.

BTW: Can you explain from where you have the values of sigma_WR? What was the study design?