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Rev Alerg Mex. 2019 Apr-Jun;66(2):246-253. doi: 10.29262/ram.v66i2.625.

[From research to practice: clinical phases for drug development].

[Article in Spanish; Abstract available in Spanish from the publisher]

Author information

1
Instituto Mexicano del Seguro Social, Centro Médico Nacional Siglo XXI, Hospital de Pediatría, Ciudad de México, México. villasis@gmail.com.

Abstract

in English, Spanish

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.

KEYWORDS:

Clinical research; Clinical trials; Drug design

PMID:
31200422
DOI:
10.29262/ram.v66i2.625

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