Bioequivalence and Bioavailability Forum

Hi Pash,

please give complete information in the future; see also this post #4. Which jurisdiction / method are you targeting at (the FDA’s RSABE, the EMA’s ABEL)?

❝ As per in the post, I have worked out outlier calculation on my data of 12 subjects.

Did you read the post in its entirety (especially the linked RTR-guidance)? Keep in mind that FDA’s guidance you maybe had in mind is 15 years old. Even then, you should have contacted the FDA before running the analysis.

If you want to submit to the FDA:

The minimum sample size for RSABE is 24 (dosed). I doubt that you had 13 drop outs in the study and that the FDA would accept removal of an outlier of the test product. Even if the FDA generously would accept removal of subject #12 the study would still fail (PE >125.00%, critbound >0). So why all that fuzz?

If you want to submit to the EMA:

The minimum sample size is 12 eligible subjects. Bad luck with 11. Statistical tests to assess outliers are not acceptable. Furthermore, only the reference product should be assessed for potential outliers by box plots (in your case it was after test).

If this was a pilot study of course you are free to do anything you prefer. However, you should be very wary and not close your eyes / cross fingers by removing an outlier after the test product!