Bioekvivalentsust

Bioekvivalens refers to the principle that two pharmaceutical products containing the same active ingredient are bioequivalent if they are expected to have the same therapeutic effect. This is primarily determined by comparing their pharmacokinetic profiles, specifically the rate and extent of drug absorption into the bloodstream. If a generic drug exhibits a similar rate and extent of absorption as the reference listed drug, it is considered bioequivalent.

This concept is crucial for the approval and use of generic medications. Regulatory agencies like the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) require bioequivalence studies to ensure that generic drugs are as safe and effective as their brand-name counterparts. These studies typically involve administering the drug to a group of healthy volunteers and measuring drug concentrations in their blood over time.

Key parameters assessed in bioequivalence studies include the maximum concentration of the drug in the blood (Cmax) and the total amount of drug absorbed (Area Under the Curve, AUC). If the confidence intervals for these parameters fall within specified ranges (usually 80-125%), the generic drug is deemed bioequivalent to the reference drug. This demonstrates that the generic product will deliver the same amount of active ingredient to the systemic circulation at the same rate as the original product, leading to comparable therapeutic outcomes.