Bioequivalence and Bioavailability Forum

Dear DLabes!

❝ I cannot imagine any criterion to decide what R1 and R2 is, if it is the same product, same batch and so on.

Yes, true. I thought I may overcome these problems in ‘fixing’ treatments – of course arbitrarily – in order to stay within a conventional layout.

❝ What you have is only

❝   S/P  |  I  II
❝  ------+---------
❝    RR  | µR  µR+p

❝ with µR the mean for R (your Reference product) and p a period effect.

❝ Within a subject you have to add an error term to specify the full model.

❝

❝ Thus you cannot and need not randomize any arbitrary sequences.

❝

❝ I would just run an ANOVA with a fixed period effect and a random subject effect. The residual error is then what you are looking for, I think.

Thanks, that helped a lot!