Get How Bioequivalence Are Documented

Two products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action.

In general, bioequivalence is assessed using three parameters namely, Cmax, tmax and AUC. Urinary excretion data may also be used if the amount excreted unchanged is significant.

Bioequivalence is usually studied by administering dosages to subjects and measuring concentration of the drug in the blood just before and at set times after the administration. These data are then used to determine if the drugs are absorbed at the same rate.

Possible methods for assessing bioavailability include determining drug liberation and dissolution at the administration or absorption site, determining free drug in systemic circulation, measuring pharmacologic effect or clinical response, and determining urinary excretion of the drug.

In general, bioequivalence is evaluated by comparing the bioavailability of the test, and the reference products, in crossover clinical studies on healthy subjects. The study may include the evaluation of bioavailability of products administered with, and without, food.

Bioequivalence is usually studied by administering dosages to subjects and measuring concentration of the drug in the blood just before and at set times after the administration. These data are then used to determine if the drugs are absorbed at the same rate.

The bioavailability studies are done by measuring the concentration of the drug in the plasma or blood after administration of drug following systemic protocol of studies and documented over time.

, an anticoagulant, and , an antiseizure drug, are examples of such drugs.