920 resultados para distributional equivalence


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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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Pós-graduação em Ciências Biológicas (Zoologia) - IBRC

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Pós-graduação em Ciências Biológicas (Zoologia) - IBRC

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A regulamentação sanitária de medicamentos é uma das oito diretrizes da Política Nacional de Medicamentos. Trata-se da fiscalização e regulamentação de registro de medicamentos e da autorização de funcionamento desde os produtores até o varejo de medicamentos, bem como das restrições àqueles sujeitos a controle especial. A regulamentação sanitária de medicamentos tem como objetivo garantir eficácia, segurança, qualidade e custo aos produtos farmacêuticos. Os estudos clínicos dos medicamentos de Referência, a bioequivalência ou biodisponibilidade relativa e testes de equivalência dos medicamentos similares e genéricos são meios de avaliar a eficácia e a segurança. A qualidade é garantida lote a lote pelas Boas Práticas de Fabricação e Controle dos produtos farmacêuticos e a certificação da empresa pela ANVISA. O custo é avaliado pela câmara técnica de medicamento (CMED), que estabelece os critérios para fixação e ajuste de preços dos produtos farmacêuticos. No pós-registro, a efetividade, segurança e qualidade dos produtos são avaliadas por meio das comprovações exigidas na renovação do registro e, principalmente, pelo programa de farmacovigilância. Palavras-chave: Registro de Produtos. Medicamentos de Referência. Medicamentos Similares. Medicamentos Genéricos. Alteração de Registro de Produtos. ABSTRACT Health Regulations for Drugs The health regulation of drugs is one of eight guidelines issued within the National Drug Policy. It refers to the supervision and regulation of drug registration and the approval of operations, from the manufacturers to the retailers of medicines, as well as the restrictions that apply to drugs under special control. The health regulation of medicines is aimed at controlling the effectiveness, safety, quality and cost of pharmaceutical products. Clinical studies of brand-name (innovator) medicines, bioequivalence or relative bioavailability and the equivalence tests of generic and ‘similar’ brand-name drugs are means used to assess efficacy and safety. Quality is assured on a batch-to-batch basis by compliance with the Good Manufacturing Practices and Control of pharmaceutical products and by the certification of companies offered by ANVISA. The cost of a medicine is assessed by the Technical Chamber of Medicine (CMED), which establishes the criteria for setting and adjusting the prices of pharmaceutical products. After registration, the effectiveness, safety and quality of products are monitored by means of the tests required on renewal of registration and especially by the pharmacovigilance program. Keywords: Product Registration. Original Brand-name Drugs. Similar Drugs. Generic Drugs. Modification of Product Registration.

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

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Pós-graduação em Desenvolvimento Humano e Tecnologias - IBRC

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Pós-graduação em Fonoaudiologia - FFC

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A-Nperp, Pg-Nperp e mandibular plane). Thirty patients (male or female), with age varying from 19 to 48 years old were analyzed. All patients were diagnosted with mandibular retrognathism and submitted to bilateral sagital mandibular advancement. All tracings were performed in lateral cephalometric radiographs obtained one week before surgery. The intraclass correlation coefficient analysis (ICC), the t test adjusted for Tukey-Kramer test and Schuirmann test were applied. The results showed that the manual tracings and Nemotec® tracing had excellent reliabilities for all measures (ICC > 0.98). The Dolphin Imaging® showed low reliability in anterior facial height (value of ICC = 0.70), Co-A (value of ICC = 0.47) and Co-Gn (ICC value = 0.49). In A-Nperp, Pg-Nperp, Mandibular plan, SNA and SNB there were no differences between the 3 tracings (p > 0.05), for the anterior facial height measures differences were found between the Dolphin Imaging® and Nemotec® tracings, but no differences were observed as compared to the manual tracing (p > 0.05), in Co-A and Co-Gn measures t Dolphin Imaging® presented a significantly lower mean than the other methods (p > 0.05). The manual tracings were equivalent in 6 of 8 measures (A-Nperp, Pg-Nperp, md Plan, SNA, SNB and Co-A), there was no equivalence between the methods in the anterior facial height and Co-Gn measures (p < 0.01). The Dolphin Imaging® method was not equivalent in any of the 8 measures. It was concluded that in the manual tracing only the Co- Gn, Pg-Nperp and SNB measures confirmed the diagnosis of mandibular retrognathism, and the Nemotec® software showed better results than the Dolphin Imaging® software.

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The objective of this work is to develop a non-stoichiometric equilibrium model to study parameter effects in the gasification process of a feedstock in downdraft gasifiers. The non-stoichiometric equilibrium model is also known as the Gibbs free energy minimization method. Four models were developed and tested. First a pure non-stoichiometric equilibrium model called M1 was developed; then the methane content was constrained by correlating experimental data and generating the model M2. A kinetic constraint that determines the apparent gasification rate was considered for model M3 and finally the two aforementioned constraints were implemented together in model M4. Models M2 and M4 showed to be the more accurate among the four developed models with mean RMS (root mean square error) values of 1.25 each.Also the gasification of Brazilian Pinus elliottii in a downdraft gasifier with air as gasification agent was studied. The input parameters considered were: (a) equivalence ratio (0.28-035); (b) moisture content (5-20%); (c) gasification time (30-120 min) and carbon conversion efficiency (80-100%). (C) 2014 Elsevier Ltd. All rights reserved.

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The aim of this work is to develop stoichiometric equilibrium models that permit the study of parameters effect in the gasification process of a particular feedstock. In total four models were tested in order to determine the syngas composition. One of these four models, called M2, was based on the theoretical equilibrium constants modified by two correction factors determined using published experimental data. The other two models, M3 and M4 were based in correlations, while model M4 was based in correlations to determine the equilibrium constants, model M3 was based in correlations that relate the H-2, CO and CO2 content on the synthesis gas. Model M2 proved to be the more accurate and versatile among these four models, and also showed better results than some previously published models. Also a case study for the gasification of a blend of hardwood chips and glycerol at 80% and 20% respectively, was performed considering equivalence ratios form 0.3 to 0.5, moisture contents from 0%-20% and oxygen percentages in the gasification agent of 100%, 60% and 21%. (C) 2013 Elsevier Ltd. All rights reserved.

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Different mathematical methods have been applied to obtain the analytic result for the massless triangle Feynman diagram yielding a sum of four linearly independent (LI) hypergeometric functions of two variables F-4. This result is not physically acceptable when it is embedded in higher loops, because all four hypergeometric functions in the triangle result have the same region of convergence and further integration means going outside those regions of convergence. We could go outside those regions by using the well-known analytic continuation formulas obeyed by the F-4, but there are at least two ways we can do this. Which is the correct one? Whichever continuation one uses, it reduces a number of F-4 from four to three. This reduction in the number of hypergeometric functions can be understood by taking into account the fundamental physical constraint imposed by the conservation of momenta flowing along the three legs of the diagram. With this, the number of overall LI functions that enter the most general solution must reduce accordingly. It remains to determine which set of three LI solutions needs to be taken. To determine the exact structure and content of the analytic solution for the three-point function that can be embedded in higher loops, we use the analogy that exists between Feynman diagrams and electric circuit networks, in which the electric current flowing in the network plays the role of the momentum flowing in the lines of a Feynman diagram. This analogy is employed to define exactly which three out of the four hypergeometric functions are relevant to the analytic solution for the Feynman diagram. The analogy is built based on the equivalence between electric resistance circuit networks of types Y and Delta in which flows a conserved current. The equivalence is established via the theorem of minimum energy dissipation within circuits having these structures.

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To design connections between timber parts with metal dowels (nails or bolts), two phenomena must be considered: bending of the metal dowel and the embedment strength in the wood. The Brazilian Standard ABNT NBR 7190:1997 proposes the methods used in the laboratory tests to determine the embedment strength with the metal dowell and, in the absence of testing, specifies relations to calculate the embedment strength from the compression strength. The aim of this research was to compare the embedment strength values obtained by experimental tests and calculated by the relationships established by the Brazilian Standard ABNT NBR 7190:1997. By the results of the hypothesis tests, it was possible to conclude that the estimate of the embedment strength parallel to the grain proposed by the Brazilian standard ABNT NBR 7190:1997, establishing equivalence with the strength compression results in the same direction, must be effective to the wood species Pinus taeda L., however, the same was not found in the perpendicular direction with respect to the grain, possibly explained by the alpha(e) values in the equation to calculed fe(90)