bioegyenértékség

Bioegyenértékség is a Hungarian term that translates to "bioequivalence" in English. It is a concept used in pharmacology and drug development to assess whether two medicinal products containing the same active ingredient are interchangeable. Specifically, bioequivalence means that the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action are essentially the same as that of another drug product.

This assessment is crucial for generic drugs. When a patent expires for an original brand-name drug, pharmaceutical companies can develop generic versions. To gain regulatory approval, these generic drugs must demonstrate bioequivalence to the reference listed drug. This is typically achieved through clinical studies that measure pharmacokinetic parameters, such as the maximum concentration of the drug in the blood (Cmax) and the area under the plasma concentration-time curve (AUC), which represents the total exposure to the drug.

If a generic drug is bioequivalent to the reference product, it is assumed to have the same therapeutic effect and safety profile. This allows healthcare providers and patients to confidently switch between the brand-name and generic versions of a medication, promoting cost-effectiveness in healthcare without compromising patient outcomes. Regulatory agencies worldwide, such as the FDA in the United States and the EMA in Europe, have established guidelines and standards for demonstrating bioequivalence.