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

posted by Sivakrishna – India, 2020-06-01 11:47 (502 d 10:38 ago) – Posting: # 21494
Views: 1,229

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.

Complete thread:

Activity
 Admin contact
21,729 posts in 4,543 threads, 1,543 registered users;
online 5 (0 registered, 5 guests [including 5 identified bots]).
Forum time: Saturday 22:25 CEST (Europe/Vienna)

If you want to converse with me,
define your terms.    Voltaire

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5