Biopharmaceutical Quality and Interchange of Drugs
DOI:
https://doi.org/10.30827/ars.v62i3.15917Keywords:
Therapeutic equivalency, interchangeability of Drug, generic drug, reference drugsAbstract
Introduction: The pharmaceutical industry seeking approval to market a generic drug must submit data demonstrating that the generic formulation provides the same quality, efficacy, and safety of the innovative drug. Therefore, most orally administered generic drugs are approved based on the results of one or more physicochemical and biopharmaceutical studies to demonstrate bioequivalence and subsequent interchangeability.
Objective: Identify in research articles the possible differences between the physicochemical and biopharmaceutical tests of bioequivalence of generic drugs with that of their corresponding innovative equivalents.
Method: The original research studies, published from January 2003 to December 2019, were reviewed. 4 databases were consulted Pubmed, ScienceDirect, Lilacs, Scielo. In English and Spanish. The descriptors used were generic medicine, bioequivalence, therapeutic equivalence and interchangeability, likewise only those articles where their study pharmaceutical form was tablets were selected.
Results: A total of 40 articles were selected for evaluation, of which 19 reached the conclusion of bioequivalence, another 19 determined non-bioequivalence, for 1 there was no definitive conclusion, while in a study that evaluated 3 drugs, the conclusion was no bioequivalence for 2 of them and bioequivalence for one.
Conclusions: The review reveals that the studies are insufficient to indicate bioequivalence between multi-source (generic) and innovative drugs, so that bioequivalence studies need to be expanded.
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