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Intercambiabilidad NOM-177 (Sí/No)

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Intercambiabilidad NOM-177 (Sí/No)

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Desafío de falso o verdadero sobre la NOM-177-SSA1-1998

Created by

Diana Vásquez
Diana Vásquez
Mexico

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Intercambiabilidad NOM-177 (Sí/No)
 

Intercambiabilidad NOM-177 (Sí/No)Online version

Desafío de falso o verdadero sobre la NOM-177-SSA1-1998

by Diana Vásquez
1

La NOM-177-SSA1-1998 incluye criterios para la evaluación de perfiles de disolución en formas farmacéuticas orales de liberación inmediata dentro del apartado 7.

2

El índice de la NOM-177-SSA1-1998 señala que el capítulo 7 trata sobre la verificación y calibración del equipo de disolución.

3

La norma establece que, para la disolución, se deben realizar perfiles de disolución con al menos cinco tiempos de muestreo para caracterizar la curva.

4

En el apartado 8, la NOM-177-SSA1-1998 prohíbe el uso de diseños cruzados para estudios de bioequivalencia.

5

La norma indica que para la validación de métodos analíticos no es necesario incluir matriz biológica en el rango de validación.

6

El apéndice y las secciones de la NOM-177-SSA1-1998 detallan criterios para la excelencia de métodos analíticos y la documentación de informes de estudios.

7

Según la NOM-177-SSA1-1998, los terceros autorizados pueden realizar pruebas sin necesidad de aprobarse previamente por autoridades sanitarias.

8

En la NOM-177-SSA1-1998 se especifica que las pruebas de bioequivalencia en humanos se contemplan en el capítulo 8.

9

El documento establece que la intercomparabilidad se demuestra únicamente mediante pruebas in vitro y no se requieren estudios en humanos.

10

El capítulo 7 de la NOM-177-SSA1-1998 exige que el perfil de disolución se contraste solo con un único tiempo de muestreo para simplificar el análisis.

 
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