Bioequivalence (BE), Bioavailability (BA) Studies Assay Testing Services | NorthEast BioLab

What Are Bioequivalence And Bioavailability Studies?

Bioequivalence and Bioavailability: Measuring and Comparing Systematic Drug Circulation

Bioavailability of drugs is the concentration of the drug compound that reaches the systemic circulation or the site of action.

Most of the medicines or pharmaceuticals consumed orally reach the systemic circulation through the gastrointestinal tract. These drug compounds then enter the site of action through the systemic circulation. Bioavailability of drugs is measured by assessing the active ingredient (API) concentration of the drug and any metabolites in plasma or serum. The API concentration also helps in determining the active ingredient release from the drug compounds along with its absorption, distribution, metabolism, and excretion.

The three primary variables of pharmacokinetic studies used in assessing the bioavailability of drugs are i) maximum concentration of the drug in the systemic circulation (Cmax), ii) time to reach this concentration (Tmax), and iii) time-drug concentration area under the curve (AUC).

If the bioavailability of two drug products is similar, the drug products are called bioequivalent.