Bioequivalence Guidelines

Bioequivalence guidelines are a set of standards used to compare two medications, typically a brand-name drug and its generic version. These guidelines ensure that the generic drug performs similarly in the body to the original, meaning it should release the same active ingredient at the same rate and to the same extent. This comparison aims to ensure safety, effectiveness, and quality, allowing patients to switch to generics confidently. Regulatory agencies, like the FDA, oversee these studies to make sure that generics are just as reliable as their branded counterparts.