Regarding used normal Two-way crossover program was used for un-scaled average [Study Assessment]
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.