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El Viaje de un Fármaco

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El Viaje de un Fármaco

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About this activity

Descubre el negocio y las fases del medicamento

Created by

Joaquin Sandoval
Joaquin Sandoval
Mexico

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El Viaje de un Fármaco
 

El Viaje de un FármacoOnline version

Descubre el negocio y las fases del medicamento

by Joaquin Sandoval
1

¿Qué porcentaje representa el éxito típico de Fase I para avanzar a la siguiente fase?

2

¿Qué objetivo tiene la Fase I en un ensayo clínico?

3

¿Qué porcentaje de compuestos que llegan a Fase III suelen aprobarse?

4

¿Qué bloquea la seguridad en el desarrollo de fármacos?

5

¿Qué cubre la Fase IV (farmacovigilancia)?

6

¿Qué costo promedio se menciona para el desarrollo completo de un fármaco?

7

¿Qué sucede durante la Fase II?

8

¿Qué significa ADME en farmacología?

9

¿Cuántas moléculas identificadas típicamente alcanzan el mercado?

Explicación

La Fase I evalúa tolerancia y dosis; ~63% avanza a Fase II.

Se buscan dosis tolerables y efectos secundarios.

La aprobación regulatoria es de menor proporción en Fase III.

La seguridad es prioritaria en Preclínica antes de humanos.

La vigilancia continúa tras la aprobación.

El proceso es caro y tardío incluso contando fracasos.

Se busca función real frente a la enfermedad y dosis óptima.

ADME describe el recorrido del fármaco en el cuerpo.

La tasa de éxito es extremadamente baja.

 
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