Bioequivalence and Bioavailability Forum

Dear All,

Good Afternoon,

One of my close friend asked the below query
Two-way cross over ANOVA model calculation was used for Unscaled average bio equivalence instead of Progesterone Guidelines program and study was submitted FDA regulatory. when he used the two-way crossover program study was met bio equivalence criteria (i.e., 80.00-125.00%). However, with the progesterone guidelines the study is not meeting Bio equivalence criteria for Cmax PK parameter (upper limit showing 126.14%). How can we justify this failure. please help to my friend.

Thanks in advance.

Thanks and Regards

G. Siva Krishna Teja.