Bioequivalence in Pharmacokinetics

In pharmacokinetics, the term bioequivalence is used to assess the expected in-vivo biological equivalence of two different versions of a drug, where one of them is usually commercially available and is used as a reference drug.

If two products are said to be bioequivalent it’s expected that their behavior in the human body is, for all intents and purposes, the same.

The World Health Organization generally considers two formulations to be bioequivalent if a 90% confidence interval for the ratio of the generic/ tested product lies within an 80.00-125.00% acceptance range for the two observed parameters (AUC0-t and cmax).

For high-variable finished pharmaceutical products, the applicable acceptance range for the cmax parameter can be widened, or in cases of narrow therapeutic drugs, tightened.

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