ABSTRACT

The degree of assessment of bioequivalence (BE) of drug product is highly inuenced by the regulatory environment of the country of marketing. Highly regulated markets have more stringent regulatory policy than countries that are not tightly regulated. The magnitude of regulatory inuence is often dictated by the availability of resources, expertise, and lack of regulation or its implementation. Thus, there is a greater need to harmonize the regulatory environment globally for BE assessment so that the drug product marketed in different parts and regions of the world would have optimum drug product quality in terms of interchangeability.