2021-02-23 19:35
(56 d 00:43 ago)

Posting: # 22223
Views: 290

 Obeticholic 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]
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