
Bioequivalence Studies
Bioequivalence studies are tests done to compare two versions of a drug, usually a brand-name and its generic counterpart. The goal is to ensure that the generic works in the same way and is absorbed in the body at a similar rate and extent as the brand-name drug. This is important because it assures doctors and patients that generics are equally effective and safe. These studies typically involve healthy volunteers and measure drug levels in the blood over time. If the results show no significant differences, the drugs are considered bioequivalent, allowing the generic to be approved for use.