Obeticholic Acid Study [Design Issues]

posted by Researcher101 – Egypt, 2021-02-23 21:35 (649 d 17:21 ago) – Posting: # 22223
Views: 908

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]

Complete thread:

UA Flag
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
25 visitors (0 registered, 25 guests [including 9 identified bots]).
Forum time: 14:56 CET (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz