ABSTRACT
Chemical equivalence is relatively easy to establish; the gulf between the chemical equivalence
of a multisource drug product and its bioequivalence is attributed mainly to the differences in
the physical characteristics of the active drug, the choice and characteristics of excipients, the
specification of the drug delivery system, and also how the drug is tested for bioequivalence. 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 bioequivalence of the tested
dosage forms.
