Pre-dose concentrations in period 2 [Study Assessment]
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
Edit: Category changed; see also this post #1. [Helmut]
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
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Pre-dose concentrations in period 2Averroes 2011-02-22 14:05
- Pre-dose concentrations in period 2 Helmut 2011-02-22 14:45
- Pre-dose concentrations in period 2 Averroes 2011-02-22 18:14
- Pre-dose concentrations in period 2 Helmut 2011-02-22 14:45