Resumo

ESTEVEZ, Francisco; PARRILLO, Susana  e  CEDRES, Mónica. Estudios de bioequivalencia in vivo para demostrar la intercambiabilidad de medicamentos. Rev. Méd. Urug. [online]. 2012, vol.28, n.3, pp.165-173. ISSN 1688-0390.

Abstract Introduction: the demand to prove the interchangeability of generic drugs with innovative medicines originated in 1970, in the developed world. Objective: the present article comprises a brief historical summary, pointing out the first drugs that caused bioequivalence problems. Results: the study states the implementation of interchangeability in Latin America started the first decade of the current century, encouraged by a working team of the PAHO, and in January, 2007, Uruguay passed the first laws on this matter. The concepts of drug bioequivalence and interchangeability are defined and the drugs that should observe this regulation are mentioned. The criteria for the design of a priorities list for the demand of bioequivalence are examined, and a review of the regulatory framework in our country since 2007 is also included in the present study. Reference to specific designs of these studies is made, aiming to assess the interaction of the new retard formulations with food or to minimize the effects of intra-individual variability on the statistical value of the studies. Conclusions: a few improvable details in terms of regulation and the impact of bioequivalence studies on prescription habits, the pharmaceutical market in Uruguay and accessibility to effective and safe drugs are commented upon.

Palavras-chave : : THERAPEUTIC, EQUIVALENCY; INTERCHANGE OF DRUGS.

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