Publication: Sistema de clasificación biofarmacéutica en la solicitud de una bioexención
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2018-02
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Abstract
El Sistema de Clasificación Biofarmacéutica (SCB) se basa en un sólido fundamento científico que clasifica los fármacos en función de los parámetros de solubilidad y permeabilidad. Estos dos factores están directamente relacionados con el proceso de absorción. Además, el SCB y plantea como objetivo la posibilidad de sustituir los ensayos realizados en humanos, in vivo, por ensayos de disolución, in vitro, de acuerdo con la clasificación obtenida para el fármaco. Actualmente la aplicación del SCB está enfocada a los estudios de bioequivalencia para demostrar el intercambio de medicamentos de administración oral, presentados en forma sólida de liberación inmediata.
La proyección de la aplicación del SCB se dirige hacia su implantación como herramienta en el desarrollo de nuevos fármacos, en el diseño y desarrollo de medicamentos y en la posibilidad solicitar bioexenciones para los fármacos de liberación inmediata.
The Biopharmaceutical Classification System (SCB) is based on a solid scientific foundation that classifies drugs according to the parameters of solubility and permeability. These two factors are directly related to the absorption process. In addition, the SCB purposes the possibility of replacing the tests performed in humans, live test, by dissolution tests, in vitro, according to the classification obtained for the drug. Currently the application of the SCB is focused on the bioequivalence studies to demonstrate the exchange of orally administered drugs, presented in solid form of immediate release and to ensure that the modifications made during the change of scale, in the formulations or processes, once approved, have no impact on their behaviour live test. The projection of the application of the SCB is directed towards implantation as a tool in the development of new drugs, in the design and development of medicines and in the possibility of biowaiver for immediate release systems.
The Biopharmaceutical Classification System (SCB) is based on a solid scientific foundation that classifies drugs according to the parameters of solubility and permeability. These two factors are directly related to the absorption process. In addition, the SCB purposes the possibility of replacing the tests performed in humans, live test, by dissolution tests, in vitro, according to the classification obtained for the drug. Currently the application of the SCB is focused on the bioequivalence studies to demonstrate the exchange of orally administered drugs, presented in solid form of immediate release and to ensure that the modifications made during the change of scale, in the formulations or processes, once approved, have no impact on their behaviour live test. The projection of the application of the SCB is directed towards implantation as a tool in the development of new drugs, in the design and development of medicines and in the possibility of biowaiver for immediate release systems.