From research to practice: clinical phases for drug development

Clinical trials become very relevant in the development of new drugs when their pharmacokinetics, pharmacodynamics, efficiency, safety and possible adverse effects are being assessed. So new drugs are available for their daily use in patients, a model has been proposed for more than four decades; Th...

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Main Authors: Jessie Nallely Zurita-Cruz, Lourdes Barbosa-Cortés, Miguel Ángel Villasís-Keever
Format: Article
Language:English
Published: Colegio Mexicano de Inmunología Clínica y Alergia, A.C. 2019-06-01
Series:Revista Alergia México
Subjects:
Online Access:http://revistaalergia.mx/ojs/index.php/ram/article/view/625
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author Jessie Nallely Zurita-Cruz
Lourdes Barbosa-Cortés
Miguel Ángel Villasís-Keever
author_facet Jessie Nallely Zurita-Cruz
Lourdes Barbosa-Cortés
Miguel Ángel Villasís-Keever
author_sort Jessie Nallely Zurita-Cruz
collection DOAJ
description Clinical trials become very relevant in the development of new drugs when their pharmacokinetics, pharmacodynamics, efficiency, safety and possible adverse effects are being assessed. So new drugs are available for their daily use in patients, a model has been proposed for more than four decades; This model consists in the realization of sequential research studies, which were called clinical phases I, II, III and IV, which begin once the drugs’ effects have been verified in cellular and animal models (preclinical phase). In this article, the general characteristics of each of the clinical phases are synthesized but, apart from that, the modifications that have been done over the years are described with the purpose of making new drugs available in a quicker way.
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spelling doaj.art-b0ed7832895d4fafbb3d81be64f960512023-09-02T20:57:39ZengColegio Mexicano de Inmunología Clínica y Alergia, A.C.Revista Alergia México0002-51512448-91902019-06-0166224625310.29262/ram.v66i2.625419From research to practice: clinical phases for drug developmentJessie Nallely Zurita-Cruz0Lourdes Barbosa-Cortés1Miguel Ángel Villasís-Keever2Instituto Mexicano del Seguro Social, Centro Médico Nacional Siglo XXI, Hospital de Pediatría, Ciudad de MéxicoInstituto Mexicano del Seguro Social, Centro Médico Nacional Siglo XXI, Hospital de Pediatría, Ciudad de MéxicoInstituto Mexicano del Seguro Social, Coordinación de Investigación en Salud, Unidad de Investigación en Análisis y Síntesis de la Evidencia, Ciudad de MéxicoClinical trials become very relevant in the development of new drugs when their pharmacokinetics, pharmacodynamics, efficiency, safety and possible adverse effects are being assessed. So new drugs are available for their daily use in patients, a model has been proposed for more than four decades; This model consists in the realization of sequential research studies, which were called clinical phases I, II, III and IV, which begin once the drugs’ effects have been verified in cellular and animal models (preclinical phase). In this article, the general characteristics of each of the clinical phases are synthesized but, apart from that, the modifications that have been done over the years are described with the purpose of making new drugs available in a quicker way.http://revistaalergia.mx/ojs/index.php/ram/article/view/625investigación clínicaensayos clínicosdiseño de fármacos
spellingShingle Jessie Nallely Zurita-Cruz
Lourdes Barbosa-Cortés
Miguel Ángel Villasís-Keever
From research to practice: clinical phases for drug development
Revista Alergia México
investigación clínica
ensayos clínicos
diseño de fármacos
title From research to practice: clinical phases for drug development
title_full From research to practice: clinical phases for drug development
title_fullStr From research to practice: clinical phases for drug development
title_full_unstemmed From research to practice: clinical phases for drug development
title_short From research to practice: clinical phases for drug development
title_sort from research to practice clinical phases for drug development
topic investigación clínica
ensayos clínicos
diseño de fármacos
url http://revistaalergia.mx/ojs/index.php/ram/article/view/625
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