bioekvivalens

Bioequivalence, often abbreviated as BE, is a concept in pharmacology and pharmacokinetics that refers to the situation where two drug products have the same rate and extent of absorption, leading to the same drug concentration over time in the body. This means that bioequivalent drugs are expected to produce the same clinical effect, assuming they have the same therapeutic dose.

Bioequivalence is typically assessed through clinical trials, where the rate and extent of drug absorption are measured using pharmacokinetic parameters such as the area under the plasma concentration-time curve (AUC) and the maximum plasma concentration (Cmax). The most common study design used to demonstrate bioequivalence is the crossover design, where each subject receives both the test and reference drug products in a randomized sequence.

Bioequivalence is a critical consideration in the development and regulation of generic drugs. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established guidelines for demonstrating bioequivalence, which typically require that the 90% confidence intervals for the ratio of the test product to the reference product for AUC and Cmax fall within a predefined range, usually 80-125%.

Bioequivalence is not the same as therapeutic equivalence, which refers to the situation where two drug products produce the same clinical effect. While bioequivalent drugs are expected to be therapeutically equivalent, the reverse is not necessarily true. In some cases, drugs may be therapeutically equivalent but not bioequivalent, due to differences in their pharmacokinetic profiles.