Bioequivalence

What is Bioequivalence?

Bioequivalence is a term in pharmacokinetics used to assess the expected biological equivalence of two proprietary preparations of a drug within the human body. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.

The United States Food and Drug Administration (FDA) has defined bioequivalence as, "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study".

What does this mean for you?

Do you have a bioequivalent product that you want to market? Do you want to prove that your product is as safe and effective as the Innovator Product? Do you want to back up your claims with strong clinical data?

At Exodon, we offer you the opportunity to have your products undergo pharmacokinetic studies which is the study of the mechanisms of absorption and distribution of an administered drug, the rate at which a drug action begins and the duration of the effect, the chemical changes of the substance in the body, and the effects and routes of excretion of the metabolites of the drug.

These studies are conducted whereby each of the preparations is administered in a cross-over study to volunteer subjects, generally healthy individuals but occasionally in patients. Serum/ plasma samples are obtained at regular intervals and assayed for parent drug (or occasionally metabolite) concentration.

For a pharmacokinetic comparison, we would facilitate for you, the testing of the plasma concentration data which are used to assess key pharmacokinetic parameters such as area under the curve (AUC), peak concentration (C_max), time to peak concentration (T_max), and absorption lag time (t_lag). Testing would be conducted at several different doses to determine bioequivalence between your product and the innovator product.

Occasionally, when blood concentration levels are neither feasible nor possible to compare the two products (e.g. inhaled corticosteroids), then pharmacodynamic endpoints rather than pharmacokinetic endpoints are used for comparison. When we say pharmacodynamic, we can use a dose-response relationship which measures the efficacy or potency of the drug on the subject which in effect can help determine the bioequivalence of your product to the innovator product.