What is a bioequivalence study?

In order to get marketing authorization, a generic must prove, among other things, its bioequivalence with the reference products.

Bioequivalence studies are intended to compare the in vivo pharmacokinetics of a test drug (generic) with the reference medicine (princeps).

The product to be evaluated (generic) and the reference product (princeps) are administered successively to healthy volunteers with an appropriate interval.

Samples of blood and / or urine shall be taken at regular intervals after administration of the medicinal product for the dosage of the active substance and / or one or more metabolites.

The pattern of these concentrations over time in each healthy volunteer provides an indication of how the substance is released for each product and how it is absorbed into the body.

The results obtained for each participant are submitted to a statistical analysis.