Bioequivalence and Bioavailability Forum

Hi Dan and Helmut,

Thanks a lot for your responses. I realize that I was not complete in my first message. The strength to be tested in the BE study falls in the therapeutic range and also in the range of linear PK. It concerns a product with a starting dose (two divided doses) and uptitration later on. Our single dose is below the maximum single daily dose. The reason I was worried is that my dose is higher thah the starting dose (I give in one single dose what the innovator gives daily in two divided doses).
I hope with this information, I am skating on thicker ice.

regards,
Petra