FARMA Bioequivalencia y Biodisponibilidad

Bioequivalencia y Biodisponibilidad

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BIOEQUIVALENCIA

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Conceptos •

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Sustancia Activa: Activa: Es el fármaco puro que contiene el medicamento medicamento.. Presentación Farmacéutica: Es aquella forma de preparar el medicamento junto con la sustancia activa para su administración en el paciente y venta. Medicamento de patente: Es aquel medicamento que es fabricado de novó, por el laboratorio farmacéutico y cuenta con la patente

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Bioequivalencia

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Es un dictamen que deben de obtener los medicamentos genéricos si quieren ser vendidos en éxico.

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!n medicamente genérico es aquel que tiene la misma sustancia activa que el medicamento original o de patente.

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Bioequivalencia •

"#$er gasto millones de dólares en la investigación y permisos para la salida al mercado de viagra, para poderlo sacar al mercado "#$er , registro su producto de origen y le otorgaron una patente por %& a'os.

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Bioequivalencia

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(l pasar esos %& a'os otros laboratorios pueden vender la sustancia activa destinada para la misma función.  ) vender viagra como medicamento medicamento genérico. genérico.

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Bioequivalencia •

*a +ofepris es la instancia regulatoria dependiente de la secretaria de salud, que otorga los permisos para poder vender los medicamentos genéricos.

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Bioequivalencia

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*a +ofepris exige a los laboratorios que quieran vender los medicamentos genéricos la reali$ación de un estudio de biodisponibilidad comparada

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Bioequivalencia

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!n estudio de biodisponibilidad comparada, compara la farmacocinética del medicamento genérico con la farmacocinét farmacocinética ica del de "atente

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Bioequivalencia

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El estudio de biodisponibilidad comparada tiene tres fases:

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Bioequivalencia

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ase +l-nic +l-nica: a: o

/e elabora un protocol protocolo o de investigación acerca del

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