Clinical research on new drugs (Phase I). Profile of scientific publications: data from the pre-clinical phase and bioethical aspects

OBJETIVO: Traçar o perfil das publicações científicas de fase I e procurar saber se a publicação oferece dados da fase pré-clínica com ênfase nos aspectos bioéticos. MÉTODOS: Foram analisados 61 artigos científicos publicados no ano de 2007, que relatam pesquisas envolvendo seres humanos com novos fármacos, medicamentos ou vacinas em fase I. Foi elaborado um roteiro para coleta de dados, com o qual fosse possível analisar e avaliar os artigos científicos. O roteiro contempla itens referentes à fase pré-clínica (associados à fase clínica) e itens referentes às características da amostra. RESULTADOS: Nos artigos analisados, a maioria das pesquisas foi realizada nos EUA. Devido ao grande número de publicações destinadas às doenças oncológicas a maioria delas foi realizada com voluntários doentes. Quanto às informações sobre a fase pré-clínica presente nas publicações de fase I observamos que são pobres ou inexistentes. Mesmo que os autores julguem a pesquisa fase I como promissora e sugiram estudos futuros de fase II, ao leitor não é possível este mesmo julgamento pela escassez de informações da fase pré-clínica. CONCLUSÃO: O perfil das publicações levanta dados que merecem reflexão e análise para melhor avaliação do que está ocorrendo com as publicações de fase I.

Scientific pedagogy at the end of the 19th century: Some readings and writings in the Portuguese debate

Through the text presented we intend to outline the debate that occurred in Portugal in the transition from the 19th to the 20th centuries. At the time, the imperatives of scientific development had reached education as a basis for the national prosperity. It was believed that Portugal had fallen behind in comparison to the other European countries because it was not capable of constructing a civilization directed by scientific criteria, through the expansion and spreading of culture. The debate over the extension of schools to increasingly broader segments of the population acquires a different meaning when the theorist of Education make use of language from several other areas of knowledge in order to create a mosaic of what has become known, since that time, as the Science of Education.

Scientific article in vitro evaluation of the influence of air abrasion on detection of occlusal caries lesions in primary teeth

The purpose of this study was to assess the influence of cleaning pits and fissures with an aluminum oxide air abrasion system on the detection of occlusal caries in primary teeth using laser fluorescence (LF) and visual examination. Methods: The sample comprised 65 pit and fissure sites on extracted primary teeth suspected to be carious. The sites were submitted to 2 visual examinations (examiner JAR) and 2 LF readings (examiner TMV). Next, the occlusal surfaces were air-abraded and re-examined thereafter using both methods. The teeth were sectioned, and the histological analysis of the sites with a stereoscopic magnifying lens at X32 magnifi cation was used as the gold standard. Results: Cohen's kappa statistic for LF and visual examination were, respectively, 0.282/0.884 before and 0.896/0.905 after air abrasion. LF showed a sensitivity of 0.28 increasing to 0.49 and a specifi city of 0.50 increasing to 0.92. Visual examination showed sensitivity of 0.78 and specifi city of 0.73. Both increased after air abrasion. Conclusion: The findings suggest that cleaning pits and fissures with aluminum oxide air abrasion increased the accuracy of LF and visual examination for detection of occlusal caries in primary teeth.

Brazilian experience with the medium-term multi-organ bioassay: Scientific and regulatory developments

In 1996 the Brazilian Institute for the Environment (IBAMA) officially adopted a variation of the multiorgan initiation-promotion DMBDD bioassay as a valid source of evidence of the carcinogenic potential of pesticides. The protocol adopted by IBAMA was a modification of the one originally proposed by researchers led by Nobuyuki Ito, from the Nagoya City University Medical School. Among the modifications established in the Brazilian protocol were the use of both sexes of the outbreed Wistar strain of rats and two positive control test chemicals. The adoption of the modified DMBDD protocol was instrumental during the last decade for qualifying technical people and to spread knowledge on chemical carcinogenesis in Brazil.

The University and its libraries: Reactions and resistance to scientific publishers

This paper addresses the relationship of copyright and the right of universities on scientific production. Information and Communication Technologies (ICTs) are causing many changes in the system of scientific communication, such as the creation of Institutional Repositories that aim to gather scientific production in digital format. The University needs quicker ways of spreading academic production and many questions are emerging due to contexts such as the Open Access movement. Thus, this paper questions the positioning of Universities, especially Public Universities, which despite having policies related to intellectual property to protect the transferring forms of research results to society; many times do not have a positioning or a mechanism that regulates the self-deposit of scientific production in these Institutional Repositories. In order to develop this paper, the following issues are addressed: lack of interest of the University in storing scientific production; reports on the relationship of the library with scientific publishing houses; the participation of faculty members and students in supporting the Free Access movement; and initiatives aimed at greater flexibility of copyright to the context of scientific production. In order to follow the development of these issues at international level, it was opted for qualitative research with non-participating direct observation to carry out the identification and description of copyright policy of important publishers from the ROMEO SHERPA site; therefore, it can be observed that there are changes regarding the publishers' flexibility before self-archiving of authors in open access institutional repositories in their universities. Given this scenario, we presente reflections and considerations that involve the progress and mainly the integration of the University and its faculty members; the institution should recommend and guide its faculty members not to transfer their copyrights, but to defend their right of copy to Institutional Repositories along with Publishing Houses.

Progreso científico-técnico para el desarrollo de América Latina = Scientific and technical progress for the development of Latin America

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