Avaliação de ensaios clínicos no Brasil: histórico e atualidades

Resumo Ensaios clínicos devem ser aprovados e acompanhados por autoridades éticas e regulatórias para garantir que a conduta ética e os aspectos técnicos das pesquisas estejam em conformidade com os padrões exigidos. O conhecimento desse processo é primordial para que estudos sejam delineados e conduzidos de acordo com os padrões aplicáveis, sendo parte essencial para a capacitação técnica e científica nacional. No Brasil, a avaliação dos estudos é realizada pelos comitês de ética em pesquisa, pela Comissão Nacional de Ética em Pesquisa e pela Agência Nacional de Vigilância Sanitária. Pesquisadores e patrocinadores alegam que o tempo para aprovação e início de ensaios clínicos limita novos estudos. No entanto, as normas brasileiras estão em contínuo aperfeiçoamento, o que demonstra interesse e capacidade em aprimorar os trâmites, sem perder a qualidade na avaliação ética

Accessing the Global Value Chain in a Changing Institutional Environment : Comparing Aeronautics and Coffee

The aim of the paper, based on empirical research in Brazil, is to investigate how supply chains have evolved over time, what factors have driven this evolution and also how a specific set of contractual practices along these chains is linked to access to international markets. The two selected case studies in the field of agriculture and aeronautics permit comparison between different modes of accessing international markets and GVCs; they illustrate the roles of transnational corporations and those of public institutions both at domestic and international levels in promoting access and determining its modes and potential spillover effects onto local production systems. More specifically, the research identifies the alternative channels of access to GVCs and international markets, and the institutional, legal and economic obstacles which prevent access or make it very costly. It looks at the role of intermediaries who control access to international markets, examining when they operate as gateways and when as bottlenecks. It examines both private and public actors, trying to disentangle when they facilitate and when they hinder access. It focuses on the most relevant factors that may attract foreign direct investments in human and physical capital to Brazil

Accessing the Global Value Chain in a Changing Institutional Environment: Comparing Aeronautics and Coffee

The aim of the paper, based on empirical research in Brazil, is to investigate how supply chains have evolved over time, what factors have driven this evolution and also how a specific set of contractual practices along these chains is linked to access to international markets. The two selected case studies in the field of agriculture and aeronautics permit comparison between different modes of accessing international markets and GVCs; they illustrate the roles of transnational corporations and those of public institutions both at domestic and international levels in promoting access and determining its modes and potential spillover effects onto local production systems. More specifically, the research identifies the alternative channels of access to GVCs and international markets, and the institutional, legal and economic obstacles which prevent access or make it very costly. It looks at the role of intermediaries who control access to international markets, examining when they operate as gateways and when as bottlenecks. It examines both private and public actors, trying to disentangle when they facilitate and when they hinder access. It focuses on the most relevant factors that may attract foreign direct investments in human and physical capital to Brazil.

Biohydroxylation of (-)-ambrox®, (-)-sclareol, and (+)-sclareolide by whole cells of brazilian marine-derived fungi.

International audienceA screening was performed using nine marine-derived fungi as biocatalysts and the natural products (-)-ambrox® (1), (-)-sclareol (2), and (+)-sclareolide (3) in order to select the microorganisms able to catalyze the biooxidation of these compounds. It was observed that only the Aspergillus sydowii CBMAI 934, Botryosphaeria sp., Eutypella sp., and Xylaria sp. presented active oxidoreductases and catalyzed the regioselective hydroxylation in the natural products. The hydroxylated metabolites obtained were 1β-hydroxy-ambrox (1a) (14 %, A. sydowii CBMAI 934); 3β-hydroxy-ambrox (1b) (17 %, Botryosphaeria sp.; 11 %, Eutypella sp.); 3β-hydroxy-sclareol (2a) (31 %, Xylaria sp.; 69 %, Botryosphaeria sp.; 55 %, Eutypella sp.); 18-hydroxy-sclareol (2b) (10 %, Xylaria sp.); and 3β-hydroxy-sclareolide (3a) (34 %, Botryosphaeria sp.; 7 %, Eutypella sp.). This is the first report of biohydroxylation of (-)-ambrox® (1), (-)-sclareol (2), and (+)-sclareolide (3) by whole mycelia of marine-derived fungi

Longevity in Untreated Congenital Growth Hormone Deficiency Due to a Homozygous Mutation in the GHRH Receptor Gene

Context: Reduced longevity observed in hypopituitarism has been attributed to GH deficiency (GHD). It is, however, unclear whether GHD or other confounding factors cause this early mortality