Results Analysis [Study As­sess­ment]

posted by Achievwin – US, 2021-08-17 21:26 (1006 d 14:10 ago) – Posting: # 22524
Views: 2,965

❝ 90% CI AUC: Lower limit - 98.35, Upper limit - 132.50, T/R ratio of AUC: 112.2

❝ 90% CI Cmax: Lower limit - 95.38, Upper limit - 127.80, T/R ratio of Cmax: 109.5

❝ Questions:

❝ 1. Primary reason for BE Failure?

Looking at your confidence intervals it looks like your ISCV computation may not be accurate, I am getting 33.6 for AUC. Your study is under powered!!!!!.

Assuming high bound of 34% ISCV and Ratio of 112 you 136 subjects (completers) for a standard 2x2 study design.

To improve probability of success go for 3-way (if your RLD CV is tight) or 4-way cross over replicated design with RSABE option. You have a shot at satisfying Bioequivalence.

Hope this helps

Complete thread:

UA Flag
 Admin contact
23,033 posts in 4,835 threads, 1,643 registered users;
45 visitors (0 registered, 45 guests [including 11 identified bots]).
Forum time: 11:37 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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