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RegisterObeticholic Acid Study [Design Issues]
Dear All, I'm about to conduct BE study on Obeticholic Acid, I'm a bit afraid from the enterohepatic circulation on OCA and its effect on AUC variability of elimination phase so I'm going for 4 periods fully replicate design to be more conservative,
my question is what are the measures should I take to ensure covering this elimination variability? Is scaling of AUC accepted by FDA or EMA or only scaling Cmax is accepted?
Should I measure AUC0-24 and AUC0-72 or AUC0-72 only and on which the confidence interval will be based? Please Advise
Edit: Category changed; see also this post #1. [Helmut]
my question is what are the measures should I take to ensure covering this elimination variability? Is scaling of AUC accepted by FDA or EMA or only scaling Cmax is accepted?
Should I measure AUC0-24 and AUC0-72 or AUC0-72 only and on which the confidence interval will be based? Please Advise
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Obeticholic Acid StudyResearcher101 2021-02-23 20:35 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
Ing. Helmut Schütz