What is a Bioequivalence study?
A bioequivalence study is a clinical study designed to evaluate and compare the therapeutic equivalence of two drugs (A and B) which contain the same dose of the same molecule.
Drug A is usually the original drug, which was approved and licensed, and is the drug of reference. Drug B is the generic drug which, in order to receive the necessary approvals and license, needs the results of a bioequivalence study.
Thus, the aim of bioequivalence studies is to check the extent to which the two drugs are similar. This is identified by comparing the rate and the extent that the molecule is absorbed after the administration of drug A versus the rate and the extent that the molecule is absorbed after the administration of drug B.
The bioequivalence study is conducted through the participation of healthy volunteers who receive some compensation for the time devoted to the study conducted.
In order to ensure the safety of the individuals participating in clinical bioequivalence studies, and before each bioequivalence study begins, it must be approved by regulatory authorities such as the Hospital’s Scientific Board, the National Ethics Committee, and the National Organization for Medicines. During the evaluation process, the competent authorities also assess the potential risks and benefits related to the bioequivalence study and decide whether the study will ultimately be approved or not.