Abstract

GONZALEZ DELGADO, Carlos; SANCHEZ GONZALEZ, Celeste A  and  ORTA HERNANDEZ, Santa Deybis. Experiencia cubana en estudios de bioequivalencia: intercambiabilidad terapéutica de genéricos. Rev Cubana Farm [online]. 2004, vol.38, n.1, pp. 1-1. ISSN 1561-2988.

Some elements on the evolution of the disolution, bioavailability and bioequivalence studies, which serve as support for new pharmaceuticals, are dealt with. The pharmaceutical, clinical and health setting of the country that has propitiated the use and manufacture of generic products and the creation of adequate conditions for the research and development of drugs was described. The antecedents of the therapeutical equivalence studies conducted in national products referred to in vitro and in vivo studies are exposed. Reference was made to the standing basic regulation that establishes the therapeutical interchangeability of the drugs in clinical practice and sets the guidelines of these studies in their quality of being the most used to show this condition. Examples of the investigated formulations were given. The paremeters and general conditions under which recent bioequivalence studies have been conducted in one of the specialized institutions of the country were characterized. It was concluded that the level attained was satisfactory.

Keywords : BIOEQUIVELENCE THERAPEUTICAL; THERAPEUTICAL EQUIVALENCE; DEVELOPMENTE FOR GENERIC OF PRODUCTS ON CUBA; THERAPEUTHICAL INTERCHANGEABILITY OF GENERIC PRODUCTS..