bioekvivalenteiksi

Bioekvivalenteiksi refers to a concept in pharmacology and pharmaceutical sciences related to the similarity of drug products. Specifically, two drug products are considered bioequivalent if they exhibit comparable bioavailability when administered in the same molar dose under the same conditions. Bioavailability, in turn, describes the rate and extent to which the active ingredient of a drug product is absorbed from its dosage form and becomes available at the site of action.

The primary purpose of demonstrating bioequivalence is to ensure that a generic drug product is therapeutically equivalent to its reference listed drug. This means that the generic version can be expected to have the same clinical effect and safety profile as the original brand-name drug. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require bioequivalence studies to approve generic drugs for market.

Bioequivalence is typically established through pharmacokinetic studies in human subjects. These studies measure the concentration of the drug in the bloodstream over time after administration of both the test (generic) and reference (brand-name) products. Key pharmacokinetic parameters, such as the area under the plasma concentration-time curve (AUC) and the maximum plasma concentration (Cmax), are compared. If these parameters fall within a predefined range of similarity (usually 80-125%), the two products are considered bioequivalent. This scientific basis allows for the substitution of generic drugs for their brand-name counterparts, contributing to healthcare cost savings.