Obeticholic Acid Study [Design Issues]
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]
- Obeticholic Acid StudyResearcher101 2021-02-23 20:35 [Design Issues]