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Register90%CI in fasting and fed condition [General Statistics]
Dear all,
May I ask something about 90%CI and ANOVA, when bioequivalence study have to be conducted under both of fasting and fed condition and the design of four-way cross-over was considered.
According to "GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE" both of draft and new version allowed the design of four-way cross-over to be able to be used.
As everyone known, the 90%CI was calculated from formula that contains the MSE from the ANOVA.
My question are
Best Regards,
BL
I am looking for your suggestion and Thanks in advance for your reply.
May I ask something about 90%CI and ANOVA, when bioequivalence study have to be conducted under both of fasting and fed condition and the design of four-way cross-over was considered.
According to "GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE" both of draft and new version allowed the design of four-way cross-over to be able to be used.
As everyone known, the 90%CI was calculated from formula that contains the MSE from the ANOVA.
My question are
- Are the 90%CI of geometric mean ratio of test/reference for fasting and fed state calculated from the same MSE? or even the ratio food/fasting and 90%CI for test and reference, Is it the same MSE? Because there is only one ANOVA.
- 2. If this design is not suitable for BE study, why they still recommend to use?
Best Regards,
BL
I am looking for your suggestion and Thanks in advance for your reply.
Complete thread:
- 90%CI in fasting and fed conditionboonchai_l 2010-05-11 16:17
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Lengthy Fasting and fed d_labes 2010-05-11 16:40
- Lengthy Fasting and fed boonchai_l 2010-05-24 11:47
- Lengthy Fasting and fed d_labes 2010-05-11 16:40
Ing. Helmut Schütz