Pharmaceutical Statistics Using SAS

8.2. Bioequivalence Testing

Bioequivalence testing is performed to provide evidence that a new formulation of drug substance (e.g., a new tablet) is equivalent in vivo to an existing formulation of drug product. Such testing is used by manufacturers of new chemical entities when making changes to a formulation of drug product used in confirmatory clinical trials, and additionally is used by the generic pharmaceutical industry to secure market access at patent expiration of an existing marketed product.

The new formulation (T) is generally studied relative to the existing formulation (R) in a randomized, open-label, cross-over trial (Jones and Kenward, 2003; Wellek, 2003; Senn, 2002; Chow and Liu, 2000). The structure of testing the question ...