Bioequivalence and Bioavailability Forum

Hi Petra
Maybe it could be a good idea to evaluate the possibility toperform the BE study on the lower strength in order to be on the safe side. I know, a bioequivalence study should in general be conducted at the highest strength. However, for products with linear pharmacokinetics and where the drug substance is highly soluble, selection of a lower strength than the highest is also acceptable. Selection of a lower strength may also be justified if the highest strength cannot be administered to healthy volunteers for safety/tolerability reasons. For products with non-linearity not caused by limited solubility but due to e.g. saturation of uptake transporters it could also be sufficient to demonstrate bioequivalence at the lowest strength. What do you think, would it be possible to perform the BE study on the lower strength and to waive the higher strength?
Kind regards
Dan


Provided that the two strengths have the same qualitative composition and are quantitatively proportional