ABSTRACT
Chemical equivalence is relatively easy to establish; the gulf between the chemical equivalence of a multisource drug product and its bioequivalence (BE) is attributed mainly to the differences in the physical characteristics of the active drug, the choice and characteristics of excipients, the speci- cation of the drug delivery system, and also how the drug is tested for BE. It is thus crucial for the formulators to be keenly aware of the subtleties in the physical and chemical properties that may lead to substantial differences in the BE of the tested dosage forms.
