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Research and Application Center of Drug Development and Pharmocokinetics

Bioavailability - Bioequivalence Studies

Bioequivalence; two drugs having the same pharmaceutical form have equivalent effects. To demonstrate bioequivalence, the maximum plasma concentrations of drugs (Cmax), the time to reach Cmax (tmax), and the areas under the plasma concentration-time curve (AUC0-∞) of drugs are generally compared in 24 healthy volunteers.
Bioavailability; is used to indicate the ratio of the amount of drug to systemic circulation that remains unchanged. In determining bioavailability, a single dose is usually administered in 12 healthy volunteers for each drug, and the plasma concentration time curve of the drug is drawn from the time of administration until the drug elimination is completed.