Bioequivalence and Bioavailability Forum

Dear Frieda,

welcome back to the forum!

❝ May I pick your gut-feeling and/or experience on the following issue?

I try not to think with my gut.
If I’m serious about understanding the world,
thinking with anything besides my brain, as tempting as that might be,
is likely to get me into trouble. Carl Sagan

❝ Due to a protocol violation in the second period of a two period cross-over BE study, the results of the second period cannot be used and this study period needs te be repeated. The violation did not present any safety hazard. The original second period is ongoing and has a long sampling interval post-dose.

My emphases. If you can’t use the data anyhow, why don’t you stop sampling at all?

I think that both of your options should be possible. Of course the first one is preferable. In any case be prepared to answer nasty questions about the protocol violation.