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RegisterRegarding used normal Two-way crossover program was used for un-scaled average [Study Assessment]
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.
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.
Complete thread:
- Regarding used normal Two-way crossover program was used for un-scaled averageSivakrishna 2020-06-01 11:47 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- (2×2×2?) ANOVA instead of mixed model Helmut 2020-06-01 15:08
Ing. Helmut Schütz