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      Garantia da qualidade aplicada à produção de radiofármacos Translated title: Quality assurance in radiopharmaceutical production

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          Abstract

          Radiofármacos são produzidos e distribuídos no Brasil há mais de 40 anos pelos Institutos da Comissão Nacional de Energia Nuclear (CNEN), particularmente o Instituto de Pesquisas Energéticas e Nucleares (IPEN), para uso em procedimentos diagnósticos e terapêuticos em Medicina Nuclear. Alguns aspectos da produção, distribuição e utilização dos radiofármacos são bastante particulares, diferenciando-se dos fármacos convencionais, tornando necessário estabelecer regulamentação específica para tais produtos. Neste sentido, existem orientações da Organização Mundial de Saúde (OMS) bem como regulamentações de órgãos sanitários de diversos países que já fazem distinção aos radiofármacos nas legislações específicas.

          Translated abstract

          Radiopharmaceuticals have been produced and distributed in Brazil for almost 40 years, by the Institutes of the Comissão Nacional de Energia Nuclear (CNEN) particularly the Instituto de Pesquisas Energéticas e Nucleares (IPEN), and applied in Nuclear Medicine in diagnostic and therapeutic procedures. Some aspects related to the production, distribution and use of radiopharmaceuticals are very uncommon and different from the conventional drugs, making necessary the introduction of an specific regulation for these radioactive drugs. In this way, the World Health Organization (WHO) and health regulatory agencies from different countries have specific legislations to radiopharmaceuticals production and use.

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          Most cited references 49

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          Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice

          (2004)
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            Technetium-99m pharmaceuticals: preparation and quality control in nuclear medicine

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              WHO Expert Committe On Specifications for Pharnaceutical Preparations: fortieth report

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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                rbcf
                Revista Brasileira de Ciências Farmacêuticas
                Rev. Bras. Cienc. Farm.
                Divisão de Biblioteca e Documentação do Conjunto das Químicas da Universidade de São Paulo (São Paulo )
                1516-9332
                March 2008
                : 44
                : 1
                : 1-12
                Affiliations
                [1 ] Instituto de Pesquisas Energéticas e Nucleares Brazil
                Article
                S1516-93322008000100002
                10.1590/S1516-93322008000100002
                Product
                Product Information: website
                Categories
                PHARMACOLOGY & PHARMACY

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