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Fases del Desarrollo de Fármacos

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Fases del Desarrollo de Fármacos

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Recorrido de la idea al fármaco seguro

Created by

Joaquin Sandoval
Joaquin Sandoval
Mexico

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Fases del Desarrollo de Fármacos
 

Fases del Desarrollo de FármacosOnline version

Recorrido de la idea al fármaco seguro

by Joaquin Sandoval
1

¿Qué se identifica en la Fase 1 del desarrollo de fármacos?

2

¿Qué se prueba en las primeras etapas para hallar candidatos?

3

¿Qué busca la optimización química en la Fase 1?

4

¿Qué evalúan las pruebas In Vitro e In Vivo en Fase 2?

5

¿Qué determina la dosis segura en Fase 1?

6

¿Qué tamaño de muestra se emplea típicamente en Fase III?

7

¿Qué se revisa en la Fase 6 de regulación?

8

¿Qué implica la Fase IV (post-comercialización)?

9

¿Qué indica la tasa de éxito mencionada?

10

¿Cuál es el objetivo principal de la Fase III?

Explicación

La Fase 1 identifica la diana biológica relacionada con la enfermedad.

En fases iniciales se cribaron moléculas para encontrar candidatos prometedores.

La optimización ajusta la molécula para mejor rendimiento y seguridad.

Se estudian toxicidad y cómo el cuerpo maneja el fármaco.

Se observa la respuesta frente a diferentes dosis para encontrar la segura.

La Fase III es extensa y multicéntrica para confirmar eficacia y seguridad.

Autoridades analizan todos los datos clínicos y preclínicos.

Se detectan efectos raros y a largo plazo tras salir al mercado.

El desarrollo farmacéutico es de alto riesgo y tasa baja de éxito.

Proporciona la evidencia necesaria para aprobación regulatoria.

 
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