305 resultados para Reprodutibilidade


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Apesar da política nacional de medicamentos propor que os mesmos tenham qualidade, efi cácia e segurança, os hospitais sentinelas têm recebido notifi cações de queixa técnica, reações adversas e suspeita de inefetividade terapêutica de medicamentos. Este estudo propôs identifi car os tipos de medicamentos notifi cados num hospital da Rede Sentinela, durante 18 meses, por suspeita de inefetividade terapêutica e verifi car a possibilidade de existência de polimorfos do fármaco, através de levantamento bibliográfi co. Foram identifi cadas 31 notifi cações de suspeita de inefetividade terapêutica de medicamentos similares, provenientes de onze fármacos diferentes, dos quais cinco podem apresentar polimorfos. No entanto, não signifi ca que os demais fármacos não apresentem polimorfos, sendo necessários estudos mais prolongados sobre o polimorfi smo, priorizando os estudos de fármacos com histórico de notifi cação de inefetividade terapêutica. Dados do presente estudo sugerem que testes de polimorfos sejam implantados na rotina do controle de qualidade da matéria-prima do fármaco, no desenvolvimento farmacotécnico do medicamento pela indústria farmacêutica e que o órgão sanitário federal exija os testes de polimorfi smo nos estudos de equivalência farmacêutica e estabilidade para o registro e pós-registro de medicamentos similares e genéricos, a fi m de assegurar a reprodutibilidade da qualidade, segurança e efi cácia comprovadas nos estudos in vivo de bioequivalência e biodisponibilidade relativa. Palavras-chave: polimorfi smo; vigilância sanitária; medicamento genérico; medicamento similar

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Pós-graduação em Odontologia - FOA

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Objetivo:traduzir o instrumento Venous legulcer quality of life questionnaire (VLU-QoL), adaptá-lo culturalmente para o português do Brasil e validá-lo com pacientes do Hospital das Clínicas da Faculdade de Medicina de Botucatu (FMB) da Universidade Estadual Paulista (Unesp). Métodos:o questionário foi traduzido por um tradutor profissional e por dois dermatologistas especialistas na área de úlceras venosas (UV), sendo reformulado em reunião com os três tradutores. O constructo (VLU-QoL-Br) foi submetido a pré-entrevista com 10 portadores de UV para a adaptação da linguagem. Posteriormente, foi aplicado em pacientes do HC-Unesp, e como teste-reteste para verificação de sua reprodutibilidade. Resultados:foram avaliados 82 pacientes, sendo 56 (68%) do sexo feminino. A idade média foi de 67,3 anos. O questionário foi traduzido, adaptado e aplicado aos pacientes. O constructo apresentou alta consistência interna (alfa= 0,94) e adequada correlação item-total. Quando avaliados os 32 retestes, observou-se correlação intraclasse para concordância de 0,78 (p < 0,01), indicando boa reprodutibilidade do constructo. A análise fatorial confirmatória corroborou as dimensões do questionário original: atividades, psicológico e sintomas. Escores do VLU-QoL-Br se associaram, independentemente, à área total das úlceras e a menor escolaridade dos sujeitos (p < 0,01). Conclusão:a tradução, a adaptação e a validação do questionário VLU-Qol-Br demonstrou boa performance psicométrica, permitindo seu uso clínico no Brasil. É importante avaliar seu desempenho em outras regiões e em diferentes amostras de indivíduos.

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Pós-graduação em Pesquisa e Desenvolvimento (Biotecnologia Médica) - FMB

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Pós-graduação em Serviço Social - FCHS

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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Pós-graduação em Pesquisa e Desenvolvimento (Biotecnologia Médica) - FMB

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Pós-graduação em Engenharia Mecânica - FEG

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Pós-graduação em Ciência e Tecnologia de Materiais - FC

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This experimental study aimed the evaluation of the use of anthropomorphic phantoms in the analysis of the influence of the acquisition parameters in the contrast of radiographic images. The analyzed factors were the variation of the peak kilovoltage (kVp) and the product of the filament circuit by the time of exposition (mAs). The influence of these factors was verified for different anthropomorphic phantoms: foot, knee and chest. The image contrast behavior with the simulators was compared to values obtained with the use of an aluminum ladder being the behavior of this reference for analysis and discussion. To assure the reproducibility of images, quality control tests were made and evaluation of procedure conditions before the experiments. The results obtained are shown in a scale of images where it was possible to evaluate the impact in the darkness of images. Regions with different compositions were analyzed which were different in image, this way the values of optical density and contrast are represented as charts and graphics. We conclude that the use of anthropomorphic phantoms in the evaluation of the influence of tension of the tube and time of exposition in the contrast of the radiographic images is not indicated for a quantitative analysis through optical density, once they present incompatible results with the data as reference as the aluminum ladder even so these simulators present a great property in qualitative analysis regarding the differentiation of structures and subjective evaluations

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The comet assay is a method of DNA damage analysis widely used to quantify oxidative damage, crosslinks of DNA, apoptosis and genotoxicity of chemicals substances as chemical, pharmaceuticals, agrochemicals products, among others. This technique is suitable to detect DNA strand breaks, alkali-labile sites and incomplete excision repair sites and is based on the migration of DNA fragments by microeletroforesis, DNA migrates for the anode forming a “tail”, and the formed image has the appearance of a comet. The slides can be stained with fluorescence or silver, having differences in the microscopy type used for the analysis and the possibility of storage of the slides, moreover, the first one is a stained-method with more difficulties of accomplishment. The image analysis can be performed by a visual way, however, there is a disadvantage as the subjectivity on the results, that can be minimized by an automated method of digital analysis. This process was studied in this report with the aim to perceive the validation of the digital analysis turning it a quantitative method with larger reproductibility, minimizing the variability and imprecision due to the subjective analysis. For this validation we selected 50 comets photographed in a standardized way and printed, afterwards, pictures were submitted to three experienced appraisers, who quantified them manually. Later, the images were processed by free software ImageJ 1.38x, printed and quantified manually by the same appraisers. The intraclass correlation was higher to comet measures after image processing. Following, an algorithm of automated digital analysis from the measures of the comet was developed; the values obtained were compared with those 12 estimated manually after the processing resulting high correlation among the measures. The use of image analysis systems increases ...(Complete abstract click electronic access below)

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Technology is growing interest in the use of composites, due to the requirement of lighter materials and more resistant, factors essential to meet the project specifications and reduce the operational cost. In the production of high performance structural composites, considering the aerospace criteria, the domestic industry has shown interest in the process of resin transfer molding (RTM) for reproducibility and low cost. This process is suitable for producing components of polymeric composites with relatively simple geometries, consistent thicknesses, high quality finish with no size limitations. The objective of this work was machined carbon steel to make a matched-die tooling for RTM and produce two composite plates of epoxy resin and carbon fiber fabric with and without induced discontinuities, which were compared towards their impregnation with ultrasound, their properties via tensile tests and thermal analysis. In ultrasonic inspection, it was found good impregnation of the preform of both composites. In the thermal analysis it was possible to check the degradation temperature of the composites, the glass transition temperature and it was found that the composites showed no effective cure cycles, but presented good performance in the tensile test when compared with aluminum alloy 7050 T7451 . The results showed that the injection strategy was appropriate since the laminate exhibited a good quality for the proposed application

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Nuclear medicine uses non-sealed sources for exams and treatments, because the movement of these sources, source of patients injected or not, involve a wide range of environmental radiometric levels. To better control of these levels this study was aimed at monitoring points strategically distributed in all environments Sector Technical Nuclear Medicine, Hospital of the Botucatu Medical School, performing two measurements at random times daily for a period of three months, sampling the normal routine of the sector. The detector Geiger-Muller was used for the acquisition of exposure rates of the points, efficiency and reprodutibility test have shown good performance of this equipment for this purpose. The results allowed to make a projection of annual dose for each environment indicating higher risks for Occupationally Exposed Individuals as well as Public Individuals compared with the limits established by the National Commission of Nuclear Energy. Was developed a spatial map of dose that can be used as a visual warning to the regions with the highest exposure to ionizing radiation, enabling reduced risk of a potential exposure