Bioequivalence
The correct answer is A) Bioequivalence, which specifically refers to the comparison of bioavailability between two dosage forms to demonstrate that they produce similar rates and extent of drug absorption. 1, 2
Definition and Concept
Bioequivalence is the term used when comparing two drug products (typically a generic versus a brand-name product) to determine if their bioavailabilities are similar enough that their clinical effects will be essentially the same. 1, 3
Two products are considered bioequivalent when their bioavailabilities after administration of the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, will be essentially the same. 3
The comparison focuses on pharmacokinetic parameters including the area under the curve (AUC) and maximum plasma concentration (Cmax), which characterize the extent and rate of drug absorption, respectively. 1, 4
Why Other Options Are Incorrect
Bioavailability (Option B) refers to the rate and extent to which the active drug ingredient is absorbed and becomes available at the site of action—it is a characteristic of a single product, not a comparison between two products. 1, 3
Biopharmaceutics (Option C) is a broader field that studies how the physicochemical properties of drugs, dosage forms, and routes of administration affect drug absorption and disposition, but it is not the specific term for comparing two dosage forms. 3
Biological (Option D) is too vague and non-specific to describe the comparison of bioavailability between dosage forms. 1
Regulatory Context
The U.S. FDA requires that for a generic drug to be approved as bioequivalent to a reference product, the 90% confidence interval of the pharmacokinetic ratio (generic/reference) must lie between 0.80 and 1.25 for both AUC and Cmax. 2, 3
This bioequivalence assessment allows generic drugs to be approved without necessarily requiring separate clinical efficacy and safety trials, provided bioequivalence is demonstrated. 1, 4