Bioequivalence

How it is used

The basis for approving generic drugs. Bioequivalence studies, usually in healthy volunteers, compare AUC (total exposure) and Cmax; normally the 90% confidence interval of the ratio must fall within 80–125%. The adjective is bioequivalent: 'The generic is bioequivalent to the reference product.'

Example sentences

1. The company carried out a bioequivalence study in 30 healthy volunteers.

2. Bioequivalence means the generic gives the same blood levels, not that the tablets look the same.

Common collocations

• bioequivalence study
• demonstrate bioequivalence
• bioequivalent to
• reference product

Related terms

• generic drugA medicine with the same active ingredient, strength, dosage form and effect as an original branded medicine, usually sold after the original's patent has expired.
• bioavailabilityThe proportion of a dose that reaches the general circulation unchanged and can act in the body; by definition it is 100 percent for intravenous drugs.
• marketing authorisationThe official permission from a medicines regulator that allows a company to sell a medicine for specific uses, doses and patient groups.
• plasma concentrationThe amount of a drug in a given volume of blood plasma at a particular time, used to describe how a drug behaves and to check that levels are safe.

More terms: Regulation and Medication Safety

• over-the-counter
• brand name
• controlled drug
• pharmacovigilance
• GMP
• medication error
• formulary