bioekvivalenciát

Bioekvivalencia, also known as bioequivalence, is a concept in pharmacology and drug development that refers to the similarity in the rate and extent to which two or more drug products are absorbed and become available at the site of action when administered at the same molar dose under similar conditions in the same individuals. In other words, bioequivalent drugs have the same effect on the body, regardless of their formulation or manufacturing process.

Bioequivalence is typically assessed through clinical trials, where the blood levels of the active ingredient are measured after administration of the drug products. The primary parameters used to determine bioequivalence are the area under the curve (AUC) and the maximum plasma concentration (Cmax). If the 90% confidence intervals (CIs) of the ratio of the test product to the reference product for both AUC and Cmax fall within the predefined range (usually 80% to 125%), the products are considered bioequivalent.

Bioequivalence is crucial in the development of generic drugs, as it ensures that the generic version has the same efficacy and safety profile as the brand-name drug. It also allows for the substitution of one drug product for another without changing the dosage regimen, which is important for patients who may have difficulty adhering to their medication schedules.

However, bioequivalence does not guarantee that two drug products are identical in all aspects. For example, they may differ in their excipients, which are inactive ingredients that can affect the drug's stability, solubility, and bioavailability. Therefore, bioequivalence should be evaluated on a case-by-case basis, considering the specific characteristics of the drug and the patient population.