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Acta bioethica

versión On-line ISSN 1726-569X

Resumen

MORENO EXEBIO, Luis. INVESTIGATIONS’ ETHICAL ASPECTS REGARDING PHARMACEUTICAL PRODUCTS’ BIODISPONIBILITY AND BIOEQUIVALENCE IN LATIN AMERICAN LEGISLATIONS. Acta bioeth. [online]. 2004, vol.10, n.2, pp.247-259. ISSN 1726-569X.  http://dx.doi.org/10.4067/S1726-569X2004000200012.

This paper pretends to identify the ethical criteria established in certain countries with uptodate 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 email to the medicaments’ regulating agencies in Argentina, Bolivia, Brasil, Chile, Colombia, Costa Rica, Ecuador, México, Paraguay, Perú, Uruguay and Venezuela. Conclusions show that uptodate 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

Palabras clave : ethics; biodisponibility; bioequivalence; legislation.

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