BIOEQUIVALENCE: HEALTH, COMMERCIAL AND POLITICAL IMPLICATIONS OF THIS TECHNICAL TOOL

Main Article Content

Rosa Maria Vera
Marcelo Estrin
Gustavo H. Marin

Keywords

Bioequivalence, pharmacokinetics, generic substitution, Limitations, implications

Abstract

Bioequivalence (BE) is a clinical-pharmacological research method that has acquired great relevance in most of the countries due to its health, commercial, and political importance. Some regulatory agencies require routine BE for all products registered in their national territory, while others opt for policies that require this study only for certain products. The truth is that even today there are current debates about its definition, its clinical relevance and the level of requirements that each country must ask to those companies that aim to register a new product.


The objective of this paper is to provide different perspectives on the concept of bioequivalent drugs, establish what are the advantages or disadvantages of adopting different policies on BE, identify the interests associated with this concept and clarify its real importance for public health.

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