Bioequivalence and Bioavailability Forum

Dear colleagues,

First of all I would like to give thanks for this forum, it seems very helpful.
This is my first time writting, and I'm very naive in BA/BE studies.

I would like some advice on how to justify pre-dose concentration in the 2nd period, as we found them in around 50 % of subjects. It's very clear that the wash-out period was insufficient, but I would like to report that in an elegant way.

As far as I know it should not be critical as all of them are below 5% of Cmax. Both test and reference were affected equally.

Any suggestion?

Thanks,

Averroes

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Edit: Category changed; see also this post #1. [Helmut]