Bioequivalence and Bioavailability Forum

Dear All,

Thanks for your discussion regarding Sample Size Calculation. I have a question related to Sample size calculation.

While calculating Sample size from the results of a pilot study, should we need to consider T/R ratio and Intra CV both? I mean to ask, In the formula, we have to use both Intra CV and T/R Ratio resulted from Pilot study?

In literature (FARTSSIE Sample Size Calculation), I have seen they used Intra CV and Expected T/R Ratio (not what they got in Pilot study).

If we are use Expected T/R Ratio instead of Observed, that means we are not considering the observed Difference between Test and Reference. Am I right?

What the exact and right Procedure? Please Let me know.

Waiting for reply.


Regards,
SKR.