ABSTRACT
The assessment of ‘‘Bioequivalence’’ (BE) refers to a procedure that compares the bioavailability of a drug from di¡erent formulations. Bioavailability is de¢ned as the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to re£ect the rate and extent to which the active ingredient or active moiety becomes available at the site of action. In this chapter, we will not present methods for drugs that are not absorbed into the bloodstream (or absorbed so little as to be unmeasurable), but may act locally. However, statistical methodology, in general, will be approached in a manner consistent with methods presented for drugs that are absorbed.
