Med baggrund i de komparative farmakokinetiske data er det dog muligt, at testproduktet er systemisk mindre biotilgængeligt end referenceproduktet.
During the referral procedure, it has been established that the submitted bioequivalence study was inadequate to demonstrate bioequivalence (as defined in current guidance EMEA/ CVMP/ 016/ 00-corr- FINAL), however from the comparative pharmacokinetic data it is possible that the test product is systemically less bioavailable than the reference product.