ABSTRACT
Drug development and preclinical trials are challenging processes and more than 80% to 90% of drug candidates fail to gain approval from the United States Food and Drug Administration. Predictive and efficient tools are required to discover high quality targets and increase the probability of success in the process of new drug development. One such solution to the challenges faced in the development of new drugs and combination therapies is the use of low-cost and experimentally manageable in vivo animal models. Since the 1980's, scientists have been able to genetically modify the mouse genome by removing or replacing a specific gene, which has improved the identification and validation of target genes of interest. Now genetically engineered mouse models (GEMMs) are widely used and have proved to be a powerful tool in drug discovery processes. This review particularly covers recent fascinating technologies for drug discovery and preclinical trials, targeted transgenesis and RNAi mouse, including application and combination of inducible system. Improvements in technologies and the development of new GEMMs are expected to guide future applications of these models to drug discovery and preclinical trials.
Subject(s)
Animals , Mice , Drug Discovery , Gene Transfer Techniques , Genome , Models, Animal , United States Food and Drug AdministrationABSTRACT
A utilização de animais em pesquisa é um procedimento antigo, sendo de extrema importância no desenvolvimento de novos fármacos e medicamentos. Os princípios éticos que norteiam essa prática estão em constante mudança. Atualmente a utilização de animais no ensino e/ou pesquisa está regulamentada pela Lei n.º 11.794/2008. O objetivo deste artigo é apresentar uma breve revisão da atual legislação e da importância que assumem os comitês de ética no uso animal (CEUA). Com a vigência da nova lei, a implementação dos CEUAs passou a ter maior respaldo para a análise dos projetos de aulas práticas e de pesquisas. O Ministério da Ciência e Tecnologia passará também a credenciar as instituições que pretendem criar e alojar esses animais, aumentando o controle sobre os cuidados dispensados a eles. A partir desse novo referencial, a utilização de animais terá maior controle e racionalidade com garantia do seu bem-estar.
The medical testing in animals is an old procedure and it is a very importance practice related to new drugs development. The ethical principles used as a reference to the practice are changing continuously. The animals used during the classes or researches are regulated by the Law n.º 11.794/2008. The objective of this article is to present a brief review of the legislation and the importance of the ethical committees of research with animals (CEUAs). The implementation of news laws provide to CEUAs greater support to perform the ethical review of the research projects and the practical classes. The Brazilian Ministry of Science and Technology is initiating the accreditation of the institutions which wants to raise laboratory animals, increasing control over the care provided to them. These measures will provide rational care for the experiments including animals as subjects.