What is the criterion for drugs to be deemed bioequivalent?

To determine whether two drug products are bioequivalent, the primary criterion is that the rate and extent of absorption are not significantly different. Bioequivalence means that two medications, usually a brand-name and a generic version, are expected to have the same therapeutic effect and safety profile when administered in the same dosage regimen.

The "rate" of absorption refers to how quickly the active ingredient is absorbed into the bloodstream, while the "extent" of absorption relates to the total amount of the drug that enters systemic circulation over time. For two formulations to be considered bioequivalent, it is essential that these characteristics fall within a defined range, typically established by regulatory agencies. This ensures that patients taking either formulation will experience similar effects.

Other options provided, such as significant differences in the rate of absorption or equivalence in pharmacodynamic effects, do not align with the official definition of bioequivalence. Cost comparison does not impact bioequivalence status; it's purely about the pharmacokinetic properties of the drugs in question.