Bioequivalence and Bioavailability Forum

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%.