Results Analysis [Study As­sess­ment]

posted by Achievwin – US, 2021-08-17 19:26 (107 d 23:15 ago) – Posting: # 22524
Views: 1,075

» 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

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