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Bioequivalence Studies

Meaning

Bioequivalence studies are essential pharmacokinetic investigations comparing the rate and extent of absorption of a generic or new formulation of a drug, such as a hormone replacement therapy, with a reference standard. These clinical trials scientifically demonstrate that two different pharmaceutical products containing the same active compound will deliver the same concentration of the substance to the systemic circulation. Establishing bioequivalence is paramount in endocrinology to ensure that a substituted hormone product will yield an identical physiological effect and therapeutic outcome.