Glossary entry (derived from question below)
Spanish term or phrase:
provisorio (in this context)
English translation:
interim; provisional
Spanish term
provisorio (in this context)
"Vida útil: 36 MESES PROVISORIO"
Me desorienta lo de "PROVISORIO" aquí.
TIA!
Non-PRO (1): philgoddard
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Proposed translations
interim
| ¡Gracias, Donal! |
| agree |
philgoddard
: Or provisional.
7 mins
|
|
Thanks Phil. That also works "the data from the accelerated study can be used to propose a provisional shelf life"
|
|
| agree |
lugoben
15 mins
|
|
Thanks lugoben.
|
Discussion
5. DISPOSICIONES GENERALES
5.1. Los ensayos de Estabilidad Acelerada permiten establecer un período de vida útil
provisorio.
Se deben complementar con Estudios de Larga Duración realizados en las condiciones
de almacenamiento determinadas para el producto. Forman parte de un programa serio
de estabilidad.
5.2. Los resultados de los estudios de Estabilidad de Larga Duración se emplean para:
—establecer el período de vida útil;
—confirmar el período de vida útil proyectado;
—recomendar las condiciones de almacenamiento.
5.3. Los estudios de Estabilidad Acelerada para la determinación del período de vida
útil y las condiciones de almacenamiento, pueden ser aceptados provisoriamente por un
período de 6 meses como requisito para el registro de un producto farmacéutico.
5.4. Vencido el período definido como provisorio, el período de vida útil debe ser
confirmado mediante la presentación de un estudio de Estabilidad de Larga Duración.