Obeticholic Acid Study [Design Issues]

posted by Researcher101 – Egypt, 2021-02-23 20:35 (52 d 09:03 ago) – Posting: # 22223
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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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