939 resultados para Analysis Phase


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Phase I trials use a small number of patients to define a maximum tolerated dose (MTD) and the safety of new agents. We compared data from phase I and registration trials to determine whether early trials predicted later safety and final dose. We searched the U.S. Food and Drug Administration (FDA) website for drugs approved in nonpediatric cancers (January 1990-October 2012). The recommended phase II dose (R2PD) and toxicities from phase I were compared with doses and safety in later trials. In 62 of 85 (73%) matched trials, the dose from the later trial was within 20% of the RP2D. In a multivariable analysis, phase I trials of targeted agents were less predictive of the final approved dose (OR, 0.2 for adopting ± 20% of the RP2D for targeted vs. other classes; P = 0.025). Of the 530 clinically relevant toxicities in later trials, 70% (n = 374) were described in phase I. A significant relationship (P = 0.0032) between increasing the number of patients in phase I (up to 60) and the ability to describe future clinically relevant toxicities was observed. Among 28,505 patients in later trials, the death rate that was related to drug was 1.41%. In conclusion, dosing based on phase I trials was associated with a low toxicity-related death rate in later trials. The ability to predict relevant toxicities correlates with the number of patients on the initial phase I trial. The final dose approved was within 20% of the RP2D in 73% of assessed trials.

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ResumoThe main idea of this work is based on the analysis of the electric torque through the acting of the PS in the power system, provided of a control for the compensation degree (PSC). A linear model of the single machine-infinite bus system is used with a PS installed (SMIB/PS system). The variable that represents the presence of PS in the net is associated to the phase displacement introduced in the terminal voltage of the synchronous machine by PS. For the input signals of the PSC are evaluated variations of the angular speed of the rotor, the current magnitude and the active power through the line where the PS is located. The simulations are accomplished to analyze the influence of the PS in the torque formation (synchronizing and damping), of the SMIB/PS system. The analysis are developed in the time and frequency domain.

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Principal component analysis phase shifting (PCA) is a useful tool for fringe pattern demodulation in phase shifting interferometry. The PCA has no restrictions on background intensity or fringe modulation, and it is a self-calibrating phase sampling algorithm (PSA). Moreover, the technique is well suited for analyzing arbitrary sets of phase-shifted interferograms due to its low computational cost. In this work, we have adapted the standard phase shifting algorithm based on the PCA to the particular case of photoelastic fringe patterns. Compared with conventional PSAs used in photoelasticity, the PCA method does not need calibrated phase steps and, given that it can deal with an arbitrary number of images, it presents good noise rejection properties, even for complicated cases such as low order isochromatic photoelastic patterns. © 2016 Optical Society of America.

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A method was optimized for the analysis of omeprazole (OMZ) by ultra-high speed LC with diode array detection using a monolithic Chromolith Fast Gradient RP 18 endcapped column (50 x 2.0 mm id). The analyses were performed at 30 degrees C using a mobile phase consisting of 0.15% (v/v) trifluoroacetic acid (TFA) in water (solvent A) and 0.15% (v/v) TFA in acetonitrile (solvent B) under a linear gradient of 5 to 90% B in 1 min at a flow rate of 1.0 mL/min and detection at 220 nm. Under these conditions, OMZ retention time was approximately 0.74 min. Validation parameters, such as selectivity, linearity, precision, accuracy, and robustness, showed results within the acceptable criteria. The method developed was successfully applied to OMZ enteric-coated pellets, showing that this assay can be used in the pharmaceutical industry for routine QC analysis. Moreover, the analytical conditions established allow for the simultaneous analysis of OMZ metabolites, 5-hydroxyomeprazole and omeprazole sulfone, in the same run, showing that this method can be extended to other matrixes with adequate procedures for sample preparation.

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This work presents a methodology to analyze transient stability (first oscillation) of electric energy systems, using a neural network based on ART architecture (adaptive resonance theory), named fuzzy ART-ARTMAP neural network for real time applications. The security margin is used as a stability analysis criterion, considering three-phase short circuit faults with a transmission line outage. The neural network operation consists of two fundamental phases: the training and the analysis. The training phase needs a great quantity of processing for the realization, while the analysis phase is effectuated almost without computation effort. This is, therefore the principal purpose to use neural networks for solving complex problems that need fast solutions, as the applications in real time. The ART neural networks have as primordial characteristics the plasticity and the stability, which are essential qualities to the training execution and to an efficient analysis. The fuzzy ART-ARTMAP neural network is proposed seeking a superior performance, in terms of precision and speed, when compared to conventional ARTMAP, and much more when compared to the neural networks that use the training by backpropagation algorithm, which is a benchmark in neural network area. (c) 2005 Elsevier B.V. All rights reserved.

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The successful management of change is a key factor in ensuring growth in the restaurant industry. The author discusses how to evaluate and act on a management change plan beginning with a total understanding and knowledge of the environment within which it operates.

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MEGAGEO - Moving megaliths in the Neolithic is a project that intends to find the provenience of lithic materials in the construction of tombs. A multidisciplinary approach is carried out, with researchers from several of the knowledge fields involved. This work presents a spatial data warehouse specially developed for this project that comprises information from national archaeological databases, geographic and geological information and new geochemical and petrographic data obtained during the project. The use of the spatial data warehouse proved to be essential in the data analysis phase of the project. The Redondo Area is presented as a case study for the application of the spatial data warehouse to analyze the relations between geochemistry, geology and the tombs in this area.

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Chaotic signals have been considered potentially attractive in many signal processing applications ranging from wideband communication systems to cryptography and watermarking. Besides, some devices as nonlinear adaptive filters and phase-locked loops can present chaotic behavior. In this paper, we derive analytical expressions for the autocorrelation sequence, power spectral density and essential bandwidth of chaotic signals generated by the skew tent map. From these results, we suggest possible applications in communication systems. (C) 2009 Elsevier B.V. All rights reserved.

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Background: kappa-PVIIA is a 27-residue polypeptide isolated from the venom of Conus purpurascens and is the first member of a new class of conotoxins that block potassium channels. By comparison to other ion channels of eukaryotic cell membranes, voltage-sensitive potassium channels are relatively simple and methodology has been developed for mapping their interactions with small-peptide toxins, PVIIA, therefore, is a valuable new probe of potassium channel structure. This study of the solution structure and mode of channel binding of PVIIA forms the basis for mapping the interacting residues at the conotoxin-ion channel interface. Results: The three-dimensional structure of PVIIA resembles the triple-stranded beta sheet/cystine-knot motif formed by a number of toxic and inhibitory peptides. Subtle structural differences, predominantly in loops 2 and 4, are observed between PVIIA and other conotoxins with similar structural frameworks, however. Electrophysiological binding data suggest that PVIIA blocks channel currents by binding in a voltage-sensitive manner to the external vestibule and occluding the pore, Comparison of the electrostatic surface of PVIIA with that of the well-characterised potassium channel blocker charybdotoxin suggests a likely binding orientation for PVIIA, Conclusions: Although the structure of PVIIA is considerably different to that of the alpha K scorpion toxins, it has a similar mechanism of channel blockade. On the basis of a comparison of the structures of PVIIA and charybdotoxin, we suggest that Lys19 of PVIIA is the residue which is responsible for physically occluding the pore of the potassium channel.

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Objective To compare the effects of transferring from low-dose transdermal estrogen to raloxifene (RLX), with a phase of alternate-day RLX therapy with or without low-dose transdermal estrogen, on serum lipids and fibrinogen in postmenopausal women previously administered estrogen plus progestogen therapy. Methods Sixty postmenopausal women (mean age 55 years) were randomized to one of two treatment groups: RLX + low-dose transdermal estrogen (RLX + E) or RLX + placebo. The study consisted of four 8-week phases: phase I (all subjects low-dose transdermal estrogen 25 mug/day), phase II (double-blind RLX 60 mg every 2nd day in combination with either low-dose transdermal estrogen or placebo), phase III (all subjects RLX 60 mg every 2nd day + placebo) and phase IV (all subjects RLX 60 mg/day + placebo). Results No significant differences existed between groups for baseline measurements prior to phase I. In phase I, for all subjects combined, total cholesterol and low-density lipoprotem cholesterol both showed a significant increase (median increase of 0.2 mmol/l, p = 0.008 and 0.4 mmol/l, p < 0.001, respectively), while triglycerides decreased significantly (median decrease of 0.2 mmol/l, p < 0.001). For the primary analysis (phase II to phase IV), the mean change from baseline observations showed no significant differences between the therapy groups for serum lipids, fibrinogen, vital signs or weight. In the comparison phase (phase II), changes in serum lipids, fibrinogen, vital signs and weight were not significantly different between groups. Conclusion Gradual conversion to RLX from low-dose transdermal estrogen, with a phase of alternate-day RLX therapy with or without low-dose transdermal estrogen, does not have any effect on the serum lipid profile or fibrinogen level.

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Para o projeto de qualquer estrutura existente (edifícios, pontes, veículos, máquinas, etc.) é necessário conhecer as condições de carga, geometria e comportamento de todas as suas partes, assim como respeitar as normativas em vigor nos países nos quais a estrutura será aplicada. A primeira parte de qualquer projeto nesta área passa pela fase da análise estrutural, onde são calculadas todas as interações e efeitos de cargas sobre as estruturas físicas e os seus componentes de maneira a verificar a aptidão da estrutura para o seu uso. Inicialmente parte-se de uma estrutura de geometria simplificada, pondo de parte os elementos físicos irrelevantes (elementos de fixação, revestimentos, etc.) de maneira a simplificar o cálculo de estruturas complexas e, em função dos resultados obtidos da análise estrutural, melhorar a estrutura se necessário. A análise por elementos finitos é a ferramenta principal durante esta primeira fase do projeto. E atualmente, devido às exigências do mercado, é imprescindível o suporte computorizado de maneira a agilizar esta fase do projeto. Existe para esta finalidade uma vasta gama de programas que permitem realizar tarefas que passam pelo desenho de estruturas, análise estática de cargas, análise dinâmica e vibrações, visualização do comportamento físico (deformações) em tempo real, que permitem a otimização da estrutura em análise. Porém, estes programas demostram uma certa complexidade durante a introdução dos parâmetros, levando muitas vezes a resultados errados. Assim sendo, é essencial para o projetista ter uma ferramenta fiável e simples de usar que possa ser usada para fins de projeto de estruturas e otimização. Sobre esta base nasce este projeto tese onde se elaborou um programa com interface gráfica no ambiente Matlab® para a análise de estruturas por elementos finitos, com elementos do tipo Barra e Viga, quer em 2D ou 3D. Este programa permite definir a estrutura por meio de coordenadas, introdução de forma rápida e clara, propriedades mecânicas dos elementos, condições fronteira e cargas a aplicar. Como resultados devolve ao utilizador as reações, deformações e distribuição de tensões nos elementos quer em forma tabular quer em representação gráfica sobre a estrutura em análise. Existe ainda a possibilidade de importação de dados e exportação dos resultados em ficheiros XLS e XLSX, de maneira a facilitar a gestão de informação. Foram realizados diferentes testes e análises de estruturas de forma a validar os resultados do programa e a sua integridade. Os resultados foram todos satisfatórios e convergem para os resultados de outros programas, publicados em livros, e para cálculo a mão feitos pelo autor.

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Nos últimos anos tem-se verificado a constante evolução dos mercados em plataformas na Internet como forma de melhoria não só dos serviços prestados, mas também para o aumento de vendas de produtos e respetiva internacionalização dos mesmos. Este aumento da procura por este tipo de softwares, assim como a constante evolução e atualização dos mesmos tem contribuído para que estas aplicações evoluam em termos de funcionalidades e complexidade. Isto contribui cada vez para a dificuldade de formar equipas capazes de manter e desenvolver estes sistemas sem que comprometa em grandes custos para as organizações. Neste sentido surgiram diversas ferramentas que permitem criar soluções pré desenvolvidas de aplicações na Internet denominadas de "E-commerce applications". Estas plataformas, apesar do utilizador não ter obrigatoriamente que deter conhecimentos de programação para proceder à sua instalação, são bastante restritas tanto aos serviços que podem ser usados, e na sua escalabilidade, visto que normalmente correm em servidores específicos e por vezes as configurações necessárias para instalação tornam-se bastante complexas de ser efetuadas. Pretende-se no âmbito desta dissertação de mestrado propor um modelo de uma arquitetura de um sistema baseado em mecanismos MDA para a área de retalho, particularmente em ambientes de e-commerce. Serão inicialmente sistematizados os principais tipos de ecommerce numa perspetiva de evolução histórica. Será igualmente enquadrado o MDA no desenvolvimento de um sistema de e-commerce. Neste sentido, serão equacionadas as diferenças entre o modelo típico de desenvolvimento de software e o desenvolvimento de software orientado pelas metodologias do MDA. No processo de especificação e desenvolvimento do modelo proposto será realizada uma análise de requisitos, assim como, a proposta do modelo da arquitetura de um sistema baseado em mecanismos MDA, tendo como orientação os requisitos e arquitetura definida na fase de análise. Finalmente no sentido de analisar o resultado esperado para um sistema orientado por metodologias definidas por MDA, serão realizado alguns testes no sistema desenvolvido de forma a analisar o seu desempenho e validar a sua adequabilidade no âmbito do processo de desenvolvimento de sistemas e-commerce

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The main purpose of the poster is to present how the Unified Modeling Language (UML) can be used for diagnosing and optimizing real industrial production systems. By using a car radios production line as a case study, the poster shows the modeling process that can be followed during the analysis phase of complex control applications. In order to guarantee the continuity mapping of the models, the authors propose some guidelines to transform the use cases diagrams into a single object diagram, which is the main diagram for the next phases of the development.