De la investigación a la práctica: fases clínicas para el desarrollo de fármacos

Jessie Nallely Zurita-Cruz, Lourdes Barbosa-Cortés, Miguel Ángel Villasís-Keever

Resumen


Los ensayos clínicos toman gran relevancia en el desarrollo de nuevos fármacos al evaluar la farmacocinética, farmacodinamia, eficacia, seguridad y sus posibles efectos adversos. Para que un nuevo fármaco esté disponible para su uso cotidiano en pacientes, desde hace más de cuatro décadas se propuso un modelo que consiste en la realización de estudios de investigación secuenciales que se denominaron fases clínicas I, II, III y IV, las cuales se inician una vez que se han comprobado los efectos del fármaco en modelos celulares y animales (fase preclínica). En este artículo se sintetizan las características generales de cada una de las fases clínicas, pero además se describen las modificaciones que se han realizado en el trascurso de los años, a fin de disponer rápidamente de nuevos fármacos.


Palabras clave


Investigación clínica; Ensayos clínicos; Diseño de fármacos

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Referencias


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DOI: http://dx.doi.org/10.29262/ram.v66i2.625

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