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Kit de herramientas del JECFA para la evaluación de riesgos de residuos de medicamentos veterinarios

Sección 5. Determinación de los límites máximos de residuos.













FAO. 2024. Kit de herramientas del JECFA para la evaluación de riesgos de residuos de medicamentos veterinarios – Sección 5. Determinación de los límites máximos de residuos. Roma.




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    A estas alturas, el lector ya habrá comprendido las funciones de los estudios de agotamiento tanto de residuos totales (RT) como de residuos indicadores (RI).Consulte el documento de orientación para:-revisar cómo se calcula la relación entre residuos indicadores y totales (RI:RT) en los tejidos comestibles en cualquier punto del tiempo después de la administración del medicamento;-saber cómo se calculan las estimaciones del RT en función de los datos de agotamiento del RI y de la RI:RT.
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    Las autoridades de reglamentación deben controlar la presencia de los residuos de medicamentos veterinarios en los alimentos. Los laboratorios de seguimiento no pueden cuantificar fácilmente los residuos “totales” de medicamentos. Para detectar los RT, el laboratorio de seguimiento debería realizar ensayos que detectaran y cuantificaran todos los componentes de los residuos (es decir, todos los metabolitos). En lugar de tratar de controlar los RT en los alimentos, las organizaciones de reglamentación controlan un RI.Consulte el documento de orientación para obtener información sobre estos aspectos:-las características de un RI adecuado con ejemplos de diferentes tipos de RI;-la relación entre los RI y los RT (RI:RT), en particular cómo varía dicha relación entre distintos tejidos comestibles y lo largo del tiempo;-otros enfoques de evaluación de los RT, como el residuo de interés (RoC), y conceptos relacionados como la biodisponibilidad y la bioaccesibilidad.
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    Incluso después de determinar HBGV, todavía quedan muchas incógnitas con respecto a los residuos una vez que el medicamento se administra a la especie animal objetivo (productora de alimentos). ¿En qué tejidos comestibles se encontrarán residuos del medicamento? ¿Qué residuos específicos se encontrarán en los tejidos comestibles? ¿En qué cantidad estará presente cada residuo específico? ¿Cuánto tiempo persistirán los residuos en los tejidos comestibles después de que se administre el medicamento?Consulte el documento de orientación sobre residuos totales para obtener información sobre estos aspectos:-la aplicación de estudios radiomarcados de agotamiento de residuos de medicamentos para determinar los residuos totales en tejidos comestibles;-los resultados decisivos y las limitaciones de los estudios de agotamiento de residuos totales en comparación con los estudios tradicionales de agotamiento de residuos (no radiomarcados) y la función de cada uno en la evaluación más amplia de los residuos;-la importancia de identificar y caracterizar los componentes específicos de los residuos (metabolitos) producidos por la especie objetivo mediante estudios radiomarcados de agotamiento de residuos u otros medios;-documentos de orientación pertinentes para obtener asesoramiento técnico adicional sobre la planificación y el análisis de estudios de agotamiento de residuos totales.

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