Bioequivalence and Bioavailability Forum

Dear Helmut
Thanks a lot!

❝     Higher response is considered ‘better’ → Non-Inferiority

❝     Lower response is considered ‘better’  → Non-Superiority

❝ I know, that’s confusing. Some background in this article.

You really hit the nail on the head.
Beacause we will compare the difference of complication rates of CVD surgery between two groups (group A and group B), lower response is considered ‘better’.

❝ You hope that the complication rates in group A (with medicine) are lower than in group B (without medicine), right?

However, we try to show the complication rates in group B (without medicine) are lower (or not worse or non-inferiority) than in group A (with medicine), duo to the medicine is very expensive.

And thank you very much for providing the paper and explaing the role of PowerTOST and PASS when coduct the analysis in our study. We are ignoring the key point.

Is there any other probelm for the design?

Best regards
Dennis