Bioequivalence and Bioavailability Forum

Hi Helmut,
Thanks for quick response.

❝ 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)?

Pardon me for missing out to mention the details . It is Pilot study for FDA's RSABE, however we want to know whether the outlier detection method which we had worked out according to mentioned in the paper is correct or not ?

❝ 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!

This data is of pilot study and we want to confirm the calculation only, whether it is for test product or reference product so that it can help for future pivotal studies. Specifically, if you could guide and check whether the residual values we calculated are correct or not!!

Thank you.