Bioequivalence and Bioavailability Forum

Dear Ravi,

❝ Can we use 2 treatment, 3 sequence, 3 period replicate design i.e RTR/TRR/RRT. Wheather this design will be acceptable to FDA or not and Please also tell me if above mentioned design is balanced or not.

The above reference replicated design will be acceptable by the USFDA. And the following link having that thread, may helps you regarding the design and analysis of RSABE

❝ By using above mentioned replicate design can we get the Intra CV for reference and use it for Reference scaling average bioequivalence apporach.

Yeah definitely we will get the Intra CV for reference. As this design is for that purpose only.
(For example if you are dealing with 2 treatment 4 period 2 seq replicated design you will get the intra subject CV for test and Reference individually like in the same way we will get only for Reference in this type of design.)

Thank you.