Bioequivalence and Bioavailability Forum

Hi Gopinath,

how about auditing the study before you take any further decisions?

I am hearing you more or less say that you think the products in spite of the data are BE. That's why you want to exclude the subject in question, and that's why you think there is a grounds to believe the subject in question does not reflect the product's average performance, variance taken into consideration .

Therefore, a for-cause audit might have merit. If your audit illustrates a general issue at the CRO then that's some pretty valuable knowledge to have prior to deciding on a repeat study (and especially where it is to take place).