Abstract

BAENA, Y  and  PONCE D´LEON, L.F. The biopharmaceutic drug classification, the theoretical basis and its importance in the biowaiver studies. Rev. colomb. cienc. quim. farm. [online]. 2008, vol.37, n.1, pp.18-32. ISSN 0034-7418.

The Biopharmaceutics Classification System (BCS), published in 1995 by Gordon Amidon and coworkers, is proposed based on recognizing the underlying process that is controlling the drug absorption rate and extent, namely, drug solubility and intestinal membrane permeability, classifying a drug according to this. Its objective is the possibility to set standards for in vitro drug dissolution testing methodology which will correlate with the in vivo process, avoiding human studies. The BCS can be used to classify drugs and set standards for scale-up and post-approval changes to show that the efficacy has not been altered, as well as standards for in vitro/in vivo correlation for bioequivalence studies, for solid oral immediate release products. About this, exists discusses for further potential applications of the BCS in the development of new drugs and drug products and in the possibility of biowaivers for controlled-release products.

Keywords : Biowaiver; permeability; solubility; dissolution.

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