oa SA Pharmaceutical Journal - Average, population and individual bioequivalence - answering questions on drug interchangeability : original paper



The introduction of generic medicines brings about the debate around drug efficacy and safety, where bioavailability and bioequivalence play an important role. In recent years, many questions have emerged regarding utilisation of average bioequivalence as the only criterion of evaluating bioequivalence for all drug categories. In this scenario, population and individual bioequivalence were presented as alternative criteria. This paper aims to discuss some of the main questions concerning average bioequivalence as criterion of evaluating bioequivalence, especially in the interchangeability aspect, and emphasises the main differences among these three methodologies: average, population and individual bioequivalence.


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