35 resultados para Good manufacturing practice
em Repositório Institucional UNESP - Universidade Estadual Paulista "Julio de Mesquita Filho"
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Statistical analysis of data is crucial in cephalometric investigations. There are certainly excellent examples of good statistical practice in the field, but some articles published worldwide have carried out inappropriate analyses. Objective: The purpose of this study was to show that when the double records of each patient are traced on the same occasion, a control chart for differences between readings needs to be drawn, and limits of agreement and coefficients of repeatability must be calculated. Material and methods: Data from a well-known paper in Orthodontics were used for showing common statistical practices in cephalometric investigations and for proposing a new technique of analysis. Results: A scatter plot of the two radiograph readings and the two model readings with the respective regression lines are shown. Also, a control chart for the mean of the differences between radiograph readings was obtained and a coefficient of repeatability was calculated. Conclusions: A standard error assuming that mean differences are zero, which is referred to in Orthodontics and Facial Orthopedics as the Dahlberg error, can be calculated only for estimating precision if accuracy is already proven. When double readings are collected, limits of agreement and coefficients of repeatability must be calculated. A graph with differences of readings should be presented and outliers discussed.
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Nas últimas duas décadas, o crescimento do interesse pela metodologia Seis Sigma intensificou a aplicação da abordagem estatística e de outras abordagens quantitativas com o intuito de melhorar não apenas a qualidade de produtos, serviços e processos, como também aumentar o desempenho organizacional e o processo de tomada de decisão. Este artigo trata da aplicação da abordagem estatística no contexto da gestão da qualidade em indústrias de alimentos de médio e grande porte do Estado de São Paulo com o propósito de: identificar quais ferramentas e técnicas estatísticas são mais amplamente empregadas por indústrias do setor para garantir e controlar a qualidade; avaliar a interdependência entre o sucesso da implementação de programas de qualidade e segurança alimentar como Boas Práticas de Fabricação (BPF) e sistema de Análise de Perigos e Pontos Críticos de Controle (APPCC) e o uso de estatística; e analisar estimativas do grau de relevância do pensamento estatístico e de seus benefícios como ferramenta de melhoria da qualidade. Um survey exploratório-descritivo foi realizado e os resultados revelaram que a abordagem estatística começa a ser mais valorizada nas indústrias de alimentos pela relevância de seus benefícios assim como já ocorre em outros setores. Há evidências de que a implantação bem sucedida dos programas de segurança alimentar seja uma condição primordial para o uso efetivo de estatística e de outras abordagens quantitativas.
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Background and Objectives - There are many questions and opinions about the value of routine preoperative tests as an integral part of the preanesthetic evaluation. Current trends suggest that such tests should be based on detailed clinical and physical evaluation. Since such tests are still routinely performed and questions about their real value still persist, the aim of this study was to assess the value of routine hematocrit (Ht), hemoglobin concentration (Hb), blood urea nitrogen (BUN) and serum creatinine results in patients undergoing elective surgery, to establish when they are needed and aiming at answering such questions. Methods - 1065 patients aged 12 years and above, physical status ASA I, II and III, scheduled for elective surgery were studied. Patients were divided into 7 different age groups with randomized distribution of gender. Ht, Hb, BUN and serum creatinine results, routinely asked by our surgical departments, were observed and analyzed. Variance Analysis was used for each variable, and the Bonferroni Multiple Comparison Test was used to compare group to group. Differences were considered significant when p < 0.05 (5%). Results - For all patients, 4025 laboratory tests were obtained. The number of tests was the same for each group. There were no differences in Ht and Hb values which remained within normal ranges. Considering BUN and serum creatinine, there was a difference between younger and older patients, but the results were normal in all groups. Conclusions - We concluded that mean Ht, Hb, BUN and serum creatinine values in all age groups were all acceptable for surgical patients in general. However, they are barely useful if performed regardless of clinical evaluation. Thus, such preoperative routine tests should be abandoned and the good clinical practice with common sense should prevail in indicating them.
Resumo:
Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. © 2013 by Anais Brasileiros de Dermatologia.
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
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Pós-graduação em Ciências Farmacêuticas - FCFAR
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Pós-graduação em Fisiopatologia em Clínica Médica - FMB
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Pós-graduação em Patologia - FMB
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
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Pós-graduação em Alimentos e Nutrição - FCFAR
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)