Construct · 1 fields · 1 citations

bioequivalence: a standalone construct

One name. One construct. A landmark on the map.

● anchor · interchangeable exposure, one field Nearest construct by meaning·not indexed
bioequivalence1 CONSTRUCTBioequivalenceSCHUIRMANN · TOST

A single standalone construct; nearby constructs are located against it in the Collider. Tap a field for its definition, unit, and measures.

Pharmacology

the standard judging whether two formulations of a drug deliver the active ingredient similarly enough to be interchangeable.

Bioequivalence is the standard for judging whether two formulations of the same drug (typically a generic and the reference product) deliver the active ingredient to the bloodstream similarly enough to be used interchangeably. Schuirmann's 1987 A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability established the statistical test now required, in which the ratio of exposure measures (AUC and peak concentration) must fall within preset equivalence limits. The referent is a regulatory equivalence of drug exposure between products, decided by confidence intervals on exposure ratios rather than by an ordinary test for a difference.[1]

Unit
Whether exposure ratios (AUC, peak concentration) fall within accepted equivalence limits
Recovery means
Not applicable
Measured by
Assessed by the two one-sided tests: the 90% confidence interval for the test/reference exposure ratio must lie within the equivalence bounds (commonly 80–125%)

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Nearby constructs

area under the curve3 fields · 3 citationsjingle · one area, three constructsconcentration4 fields · 4 citationsjingle · one word, four constructsconfidence4 fields · 5 citationsjingle · one word, four constructs

References

  1. Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of Pharmacokinetics and Biopharmaceutics, 15(6), 657–680. https://doi.org/10.1007/BF01068419

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