Bioequivalence and Bioavailability Forum

Hi balakotu
1. Emissions for R-R are not considered and, therefore, it is possible that equivalence limits can be reduced.
2. Do not assessed the alpha and size of CI may be greater than the 90% CI.
Those. It may be more significant difference than it seems.
Regards

Hi balakotu,

please give complete information: Sample size (if unbalanced: number of subjects per sequences), observed GMR, and 90% CI. Was it a 4-period (TRTR|RTRT) or a 3-period (TRT|RTR) design? Target power and GMR assumed in study planning?

❝ […] relaxed 90% Confidence Intervals

<nitpick>

You mean: Expanded (acceptance) limits

</nitpick>

❝ Is there any way to justify Europe regulatory authority(ies) to accept this study data?

Are you talking about ‘bending the rules’ and convince them accepting it? Chances are pretty low (patient’s risk >0.05). Furthermore, some European statisticians are already aware of the potential inflation of Type I Error in reference-scaling, which might be the case with your CV_wR of 38.9%.