Pharmaceutical equivalence and bioequivalence of drugs: reviewing concepts and quality

Abstract

Introduction: Safety, efficacy and quality of medicines are important for achieving the desired therapeutic effect, especially after 1999 when the Generic Act comes into force. Pharmaceutical equivalence and bioequivalence tests are essential for the production of generic medicines and since they have ensured the efficacy of the medicines compared to the reference medicines. Methods: A review of the literature was carried out from researches of scientific works in PubMed, Scielo and Google Scholar databases, using as keywords: pharmaceutical equivalence and bioequivalence. Development: The importance of pharmaceutical equivalence tests and bioequivalence was reported by the authors, especially when it comes to generic and / or similar drug analyzes. Pharmaceutical equivalence between two drugs is carried out by physical and physical-chemical analysis, indicating the presence of the same active principle, dose, pharmaceutical form, as well as route of administration. However, such testing does not always imply therapeutic equivalence, since differences in the excipients used and the production processes may lead to a change in the action of the drug in the body. For this, the bioequivalence test evaluates the bioavailability of drugs in different drugs, classifying them as bioequivalents when they present equivalent effects after administration of the same dose. Conclusion: The acceptance of generic and similar drugs by the population is still questioned, which may be a reflection of the quality deviations found in bioequivalence tests.