Investigations’ ethical aspects regarding pharmaceutical products’ biodisponibility and bioequivalence in Latin American legislations


  • Luis Moreno Exebio


This paper pretends to identify the ethical criteria established in certain countries with up-to-date norms on biodisponibility/bioequivalence, and to determine if such criteria really protect participants in these investigations. In order to obtain information a questionnaire on biodisponibility/bioequivalence topics was sent via e-mail to the medicaments' regulating agencies in Argentina, Bolivia, Brasil, Chile, Colombia, Costa Rica, Ecuador, México, Paraguay, Perú, Uruguay and Venezuela. Conclusions show that up-to-date norms regarding necessary ethical aspects to protect people who participate in those investigations are unequal Ethical requirements should be uniformed so as to allow a quicker legislation development in those countries that still lack it. This would also strengthen the region's pharmacaeutical regulations


Ethics, biodisponibility, bioequivalence, legislation.

Author Biography

Luis Moreno Exebio

Área de Investigación, Centro Nacional de Control de Calidad, Instituto Nacional de Salud.