Bcs Drug
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Bcs Drug List
Pharmacological therapy is essential in many diseases treatment and it is important that the medicine policy is intended to offering safe and effective treatment with affordable price to the population. One way to achieve this is through biowaiver, defined as the replacement of in vivo bioequivalence studies by in vitro studies. For biowaiver of new immediate release solid oral dosage forms, data such as intestinal permeability and solubility of the drug are required, as well as the product dissolution. The Biopharmaceutics Classification System (BCS) is a scientific scheme that divides drugs according to their solubility and permeability and has been used by various guides as a criterion for biowaiver. This paper evaluates biowaiver application, addressing the general concepts and parameters used by BCS, making a historical account of its use, the requirements pertaining to the current legislation, the benefits and risks associated with this decision. The results revealed that the use of BCS as a biowaiver criterion greatly expands the therapeutics options, contributing to greater therapy access of the general population with drug efficacy and safety guaranteed associated to low cost.
Bcs Iv Drugs
Key words: Medicines/biowaiver; Biopharmaceutics Classification System; Drugs/solubility; Drugs/permeability; Drugs/dissolution; Drugs/legislation. METHODS The laws related to biowaiver were checked at sites of the regulatory agencies of interest, ANVISA (), FDA () and EMA (), to evaluate the inclusion of BCS as a criterion to enable biowaiver. Additionally, we carried out search of scientific basis for allowing the presentation and discussion of the laws cited. With this goal bibliographic data bases PubMed (), Scopus () and SciELO () were consulted from November 2011 to February 2014, using the following search terms: biowaiver, BCS, permeability and solubility. Class Solubility Permeability I High High II Low High III High Low IV Low Low The solubility and intestinal permeability are among the main factors that govern the rate and extent of drug absorption and therefore are directly related to bioavailability ( ).
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