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

posted by Sivakrishna – India, 2020-06-01 09:47 (237 d 14:25 ago) – Posting: # 21494
Views: 893

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.

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