Bioequivalence and Bioavailability Forum

Hi everyone,

I am researching scaling and would be grateful if anyone could answer the following questions for me.

Is (uT-uR) the geometric mean ratio (point estimate) that has to be within 80 - 125 % and also the value that has to be within the limits produced bt the FDAs recommended method?

If I have a three period two sequence (TRR and RTR) partial crossover study design, is the within-subject reference variance calculated using all the reference data or just period three reference data?

Is uR the mean of all of the reference data (from all periods and sequences) or just the mean of the references in the first two periods?

Thus is the replicated reference solely for calculation of the within-subject reference varaince by which the confidence limits are widened (then period 3 data is forgotten about) and the confidence intervals calculated using a two period crossover study as normal?

Any help is much appreciated!

Thank-you,

M Murphy

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Edit: Please start a new thread, if your question is not a direct response to another post (was linked to this post and that one as well; don't double post). See here. [Helmut]