Bioequivalence and Bioavailability Forum

Hi Vivekanand!

❝ Couple of subjects were selected into the study where the BMI range is not as per protocol.

❝

❝ Can we proceed by raising protocol deviation or by a Note to file for the study.

The former. See ICH E3 Section 10.2 Protocol Deviations

All important deviations related to study inclusion or exclusion criteria, conduct of the trial, patient management or patient assessment should be described.

In the body of the text, protocol deviations should be appropriately summarised by centre and grouped into different categories, such as:

those who entered the study even though they did not satisfy the entry criteria

I would not expect a substantial impact since the comparison between treatments is based on a within-subject comparison. On the other there must have been reasons to define the BMI-range in the protocol. I casts a damning light on your procedures not complying with the protocol. Expect in the worst case that an assessor wants you to perform the BE assessment excluding these subjects.