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Bioequivalence of Peptides

Meaning

Bioequivalence of peptides refers to the scientific and regulatory standard demonstrating that two different peptide drug products, often a generic and a reference product, exhibit the same rate and extent of absorption into the systemic circulation. This determination is crucial in the clinical setting to ensure that an alternative peptide formulation delivers the identical therapeutic effect and safety profile as the original branded product. Achieving bioequivalence means that the concentration-time curves of the active peptide in the blood plasma are statistically indistinguishable. The concept is central to drug substitution and maintaining consistent patient outcomes in hormonal therapies.