Bioequivalence and Bioavailability Forum

Dear All,

I would like to ask about sample size determination for conducting William Design (3 treatment - 3 period - 6 sequence) bioequivalence. We would like to compare two test product with one reference product. Based on available literature, the drug product we would like to compare has about 19.03% intra-subject CV for AUC. Usually, we calculate the sample size by intra-subject CV from the previous study and referred to Diletti table (E Diletti, D Hauschke, and VW Steinijans, Sample size determination for bioequivalence assessment by means of confidence intervals). Is that also applicable for the 3x3x6 study? Or, is there any other method to determine sample size for william design?

I would be very thankful for your help.

Thank you very much.

Regards,
Irene I

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Edit: Category changed; see also this post #1. [Helmut]