BE Guidelines (Bioequivalence Guidelines)

Bioequivalence Guidelines establish standards to ensure that a generic medication works the same way and has the same effect as a brand-name drug. These guidelines involve testing to compare the rate and extent of absorption of both versions in the body. If they are found to be sufficiently similar within specific ranges, the generic can be approved as an equivalent, providing a safe and cost-effective alternative. Essentially, these guidelines help guarantee that patients receive medications that are equally safe and effective, regardless of whether they are brand-name or generic.