Bioequivalence and Bioavailability Forum

Hello All,

Candaian BE Guideline states that
"No more than 5% of the subjects may be considered to be outliers"

Now my questions are:

1) How to handle a situation where >5% subjects are detected to be outlier?

2) I have mentioned in protocol that `No more than 5% of the subjects shall be considered as outliers`. Now this leaves the reader of my protocol with an obvious doubt that what to do if >5% subjects are detected as outliers????? I need to clarify this too in the protocol right to avoid any biasness in data analysis?!!!!!!
How to handle this? what to mention in protocol?


Regards,
Hiren