Bioequivalence and Bioavailability Forum

Dear D. Labes,

Guess many other colleagues are looking for the answers of your QUESTION now. I don't know if I can really help here. But allow me to try first.
To calculate intra-individual variabilities and means seems not a problem for the guy like you. Or see Hauschke D, et al., "Bioequivalence Studies in Drug Development - Methods and Applications", 2007, pp. 258-9.
Why did they ask these questions? I really don't know. ABE and intra-subject variability (Liu JP, 1991)? One thing for sure is that they must see something on the output from using Drug2-replicate program. That's why they may also want to know these output contents from your study. I guess that probably you have found the answer yourself now if you have run your data with drug2-replicate program. [BTW, where to get it? Is this drug2-replicate program (SAS macros) freely available?]

❝ The company must supply the simple calculation of intra-individual variability (mean of individual experimental differences) based on experimental data, so that the results can be compared with model values obtained using the Drug2-replicate program.

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❝ Any body out there who knows to hell what they mean? Or has an idea? Variability=mean? Simple calculation? Experimental differences? Totally confused.

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❝ BTW: Drug2-replicate program is the name of a SAS project (couple of macros) implementing the Proc MIXED code as its heart.