La biosimilaridad de anticuerpos monoclonales frente a sus moléculas de referencia como concepto escalable mediante una ecuación de diseño experimental.
Tesis Materias > Biomedicina Universidad Internacional Iberoamericana Puerto Rico > Investigación > Tesis Doctorales Cerrado Español El intento de acercamiento de tratamientos biológicos, con elevado coste para los ciudadanos, ha impulsado el nacimiento y crecimiento de los medicamentos biosimilares. Moléculas cuya producción está enfocada a ser copias de los principios activos de los medicamentos de origen biológico catalogados como innovadores. Al ser moléculas biológicas, el hecho de ser copias del principio activo se hace complejo, pues pequeñas variaciones en su composición bioquímica pueden afectar a su seguridad y eficacia. A diferencia de los innovadores, cuyo razonamiento de comercialización está dirigido a la seguridad del medicamento mediante estudios clínicos, base para ser comercializado en condiciones seguras, sin embargo, los medicamentos biosimilares, se centran en que sus atributos de calidad sean los más próximos a la molécula que pretenden sustituir. Por ese motivo, mediante el estudio de los atributos críticos de calidad, la farmacología, su comportamiento en un organismo vivo y su composición es posible desarrollar una ecuación que permita facilitar la forma de estudiar la biosimilaridad de una molécula, y mediante una representación gráfica de la misma, se puede facilitar la compresión y graduar el nivel de calidad de un biosimilar. Los atributos que caracterizan a las moléculas son antagonistas o complementarios entre sí, permitiendo establecer un rango de aceptación que permita el desarrollo de un sistema de graduación de la comparabilidad entre innovadores y biosimilares, acercando el concepto hasta la fecha teórico, a un aspecto cuantitativo. Pero siempre tomando en consideración aspectos fundamentales como la incidencia del error del laboratorio en su valoración. Por lo que, basándose en un modelo radial de representación gráfica, resultante del análisis de los diferentes atributos antagonistas y complementarios, y apoyado en una clasificación cuantitativa, las agencias y compañías pueden identificar el tipo de molécula comercializada de forma estandarizada. metadata Lorenzana Suárez, Diego mail diego.lorenzana@doctorado.unib.org (2024) La biosimilaridad de anticuerpos monoclonales frente a sus moléculas de referencia como concepto escalable mediante una ecuación de diseño experimental. Doctoral thesis, SIN ESPECIFICAR.
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El intento de acercamiento de tratamientos biológicos, con elevado coste para los ciudadanos, ha impulsado el nacimiento y crecimiento de los medicamentos biosimilares. Moléculas cuya producción está enfocada a ser copias de los principios activos de los medicamentos de origen biológico catalogados como innovadores. Al ser moléculas biológicas, el hecho de ser copias del principio activo se hace complejo, pues pequeñas variaciones en su composición bioquímica pueden afectar a su seguridad y eficacia. A diferencia de los innovadores, cuyo razonamiento de comercialización está dirigido a la seguridad del medicamento mediante estudios clínicos, base para ser comercializado en condiciones seguras, sin embargo, los medicamentos biosimilares, se centran en que sus atributos de calidad sean los más próximos a la molécula que pretenden sustituir. Por ese motivo, mediante el estudio de los atributos críticos de calidad, la farmacología, su comportamiento en un organismo vivo y su composición es posible desarrollar una ecuación que permita facilitar la forma de estudiar la biosimilaridad de una molécula, y mediante una representación gráfica de la misma, se puede facilitar la compresión y graduar el nivel de calidad de un biosimilar. Los atributos que caracterizan a las moléculas son antagonistas o complementarios entre sí, permitiendo establecer un rango de aceptación que permita el desarrollo de un sistema de graduación de la comparabilidad entre innovadores y biosimilares, acercando el concepto hasta la fecha teórico, a un aspecto cuantitativo. Pero siempre tomando en consideración aspectos fundamentales como la incidencia del error del laboratorio en su valoración. Por lo que, basándose en un modelo radial de representación gráfica, resultante del análisis de los diferentes atributos antagonistas y complementarios, y apoyado en una clasificación cuantitativa, las agencias y compañías pueden identificar el tipo de molécula comercializada de forma estandarizada.
| Tipo de Documento: | Tesis (Doctoral) |
|---|---|
| Palabras Clave: | Inmunología, anticuerpo biosimilar, biosimilaridad inmunológica, comparabilidad de reacción inmunológica. |
| Clasificación temática: | Materias > Biomedicina |
| Divisiones: | Universidad Internacional Iberoamericana Puerto Rico > Investigación > Tesis Doctorales |
| Depositado: | 20 Sep 2024 23:30 |
| Ultima Modificación: | 20 Sep 2024 23:30 |
| URI: | https://repositorio.unib.org/id/eprint/11822 |
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Nut Consumption Is Associated with Cognitive Status in Southern Italian Adults
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