Bioequivalence and Bioavailability Forum

Dear Helmut! Dear All!

❝ ❝ 3. Statistical analysis: How to do [...]

❝

❝ First you have to have suitable software (SAS, WinNonlin,...) which will give you CV_intra of the reference. Then follow Method C2 given in Haidar et al. to calculate to scaled BE limits [...]

❝ [...]

❝ Procedure: if you have sigma2WR [...]

Is it really that simple?

I have read up to now from Haidar et. al.:
"[...] Furthermore,
  theta=(ln Delta)2/sigma2W0
where Delta is 1.25, the usual average BE upper limit for the untransformed test/reference ratio of geometric means, and sigma_W0=0.25. [...] A 95% upper confidence bound for (µ_T-µ_R)²/sigma²_WR determined in a BE study must be < theta, or equivalently, a 95% upper confidence bound for (µ_T-µ_R)²-theta*sigma²_WR must be <0. [...]".
(emphasis by me)

Thus I think the statistical method must calculate a confidence interval, recommended is that for the linearized SABE criterion (last in the excerpt above). This is so because we have only estimates of (µ_T-µ_R) and sigma²_WR with a certain variability.

Dave Dubins has given this above quote in his Fartssie.xls also, but I can not find a confidence interval calculation there in.