Bioequivalence and Bioavailability Forum

Dear collegues,

This query appears novice but I am not a statistician. For a HVD, I have done a 4-way pilot and the ISCV's are >30% true to the drug nature. Please let me know if I need to carry a pivotal again with a replicate design or a 2 way cross-over would do.

Also please let me know if the sample size calculation from SAS is valid for 4 way cross-over. If not how do I calculate the sample size for a replicate design based on the ISCV's from a 4 way pilot.