bioekvivalentsus

Bioekvivalentsus, also known as bioequivalence, refers to the relationship between two pharmaceutical products that contain the same active ingredient and demonstrate comparable bioavailability when administered at the same molar dose under similar conditions. This concept is fundamental in the approval process of generic drugs, ensuring that they produce the same therapeutic effect as the original branded medications.

Bioequivalence studies typically involve clinical testing in healthy volunteers to compare the pharmacokinetic parameters of the test (generic) and reference (brand-name) products. The key metrics evaluated include the maximum concentration of the drug in plasma (Cmax), the time to reach this maximum (Tmax), and the area under the plasma concentration-time curve (AUC), which represents the total drug exposure.

Regulatory agencies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require demonstration of bioequivalence before approving generic drugs for market. This ensures that generics are interchangeable with their branded counterparts in terms of safety, efficacy, and quality.

Establishing bioequivalence allows for the substitution of generic medicines, often resulting in reduced healthcare costs and increased medication accessibility. However, minor differences in excipients or manufacturing processes do not usually impact the overall bioavailability or clinical performance if bioequivalence criteria are met.

In summary, bioekvivalentsus is a critical concept in pharmaceutics and drug regulation, facilitating the approval and acceptance of generic medications while maintaining therapeutic consistency and patient safety.