Bioequivalence and Bioavailability Forum

Dear All,

We have used a replicate crossover (4 period, 2 sequence) design for testing bioequivalence of one of our formulation. Two sequences used in the design were RTRT and TRTR.

Now my question is as CV_intra for reference is well above .70 or 70% can we go for reference scaling average bioequivalence apporach (RSABE). We are going for US market.

One more question is that Can we apply RSABE if we have not specified this approach in the protocol and if yes is it acceptable to USFDA and if not what should be the alternative.

Waiting for ur invaluable comments and suggestions.