Bioequivalencia: Introducción a la correlación in vivo-in vitro. Parte I.

the quality control suggested by pharmacopeta for oral donage forms does not assure in many cases the bioequivalence of products going to the market, therefore, causes of this defficiency such as poor selection of dissolution specifications and conditions, and underestimation of the influence of critical manufacturing variable over the performance of formulations were discussed. in vivo - in vitro correlations were encouraged to be set since this is the most acceptable solution worldwide for guaranteeing batch per batch quality. also, the definitions of in vivo in vitro correlations and proposed correlation levels were presents. the importance of setting, adjustment and control of critical variables together with the obtained in vivo - in vitro correlation to determine adequate in - vitro dissolution specifications were underlined in the conclusions.