bioegyenértékesség

Bioegyenértékesség, a term in pharmacology and regulatory science, refers to the concept that two pharmaceutical products containing the same active ingredient(s) are equivalent in terms of their bioavailability and thus expected to have the same therapeutic effect. This equivalence is crucial for the approval and use of generic drugs.

Bioavailability measures the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action. For two drug products to be considered bioequivalent, their pharmacokinetic profiles must be similar. This is typically assessed through clinical studies where healthy volunteers receive single or multiple doses of both the reference product (usually the originator drug) and the test product (the generic drug).

Key parameters used to demonstrate bioequivalence include the area under the plasma concentration-time curve (AUC), which reflects the total exposure to the drug, and the maximum plasma concentration (Cmax), which indicates the peak drug levels. Statistical analysis, usually employing confidence intervals, is used to compare these parameters between the two products. If the mean of the test product's AUC and Cmax falls within a predefined range (often 80-125%) of the reference product's values, and the confidence intervals are within these limits, the products are considered bioequivalent.

Bioegyenértékesség is a fundamental principle that allows regulatory agencies to approve generic medications, ensuring they are safe and effective alternatives to brand-name drugs. This concept helps to increase access to affordable medicines and promote competition in the pharmaceutical market.