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  • About
  • The Global ETD Search service is a free service for researchers to find electronic theses and dissertations. This service is provided by the Networked Digital Library of Theses and Dissertations.
    Our metadata is collected from universities around the world. If you manage a university/consortium/country archive and want to be added, details can be found on the NDLTD website.
821

Alteração de conservantes no pós-registro e possíveis impactos na qualidade dos medicamentos fabricados no Brasil /

Pereira, Silvio Luiz Gonçalves. January 2011 (has links)
Resumo: Na sua quase totalidade, as formas farmacêuticas líquidas apresentam agentes conservantes em suas fórmulas visando a proteção contra o desenvolvimento microbiano. Entretanto, pesquisas indicam que conservantes são substâncias tóxicas, pois dependendo da concentração administrada podem provocar reações adversas ou intoxicações. A inclusão desses agentes na fórmula de um medicamento deve seguir rigorosamente os parâmetros de eficácia e segurança, garantindo assim proteção antimicrobiana máxima sem provocar danos aos usuários. Por essas razões, este estudo teve como objetivo analisar os possíveis impactos na qualidade das dispersões moleculares de uso oral comercializadas no Brasil em decorrência das alterações na concentração de excipientes no pós-registro de medicamentos, em especial a modificação "moderada" de conservantes (5 - 10%). Foram analisadas as fórmulas de todas as dispersões moleculares de uso oral, de referência, registradas na ANVISA em março de 2009, e os respectivos sistemas conservantes foram identificados. A elaboração de uma matriz "medicamentos versus sistemas conservantes" propiciou a definição dos principais sistemas conservantes empregados industrialmente e sua inserção em oito fórmulas de bancada. Os testes de efetividade antimicrobiana realizados nestas fórmulas indicaram que metade delas não atendeu aos critérios de aceitação propostos na monografia oficial (USP 32), além de outras duas que apresentaram frágil proteção antimicrobiana, pois nelas o crescimento microbiano esteve muito próximo do limite máximo permitido. Em se tratando dos riscos que tais alterações possam provocar na conservação de um medicamento, estes valores são preocupantes, especialmente em escala industrial e, no mínimo, as fórmulas não aprovadas deveriam ser retestadas / Abstract: Almost all liquid dosage forms have preservative agents in their formulas in order to protect against microbial growth. However, researches indicate that preservatives are toxic, because depending on the administered concentration they can cause adverse reactions or intoxications. The inclusion of these agents in the formulation of a product should strictly follow the parameters of efficacy and safety, thus ensuring maximum antimicrobial protection without causing harm to users. For these reasons, this study aimed to examine the possible impacts on the quality of molecular dispersions for oral administration commercialized in Brazil as a result of changes in the concentration of excipients in the post-registration of medicines, particularly the "moderate" modification of preservative agents (5 - 10%). All formulas of molecular dispersions for oral use, as reference drugs, recorded at ANVISA in March 2009 were analyzed and the preservative agents were identified. The development of a matrix "drugs versus preservative systems" led to the definition of major preservative systems used industrially and their inclusions in eight formulas studied. The antimicrobial effectiveness tests conducted on these formulas indicated that half of them did not meet the acceptance criteria proposed in the official monograph (USP 32), beyond two other formulas that presented weak antimicrobial protection, because microbial growth in them was very close to the maximum allowed. Considering the risks that such changes may result in the conservation of a drug these negative values are worrisome, especially on an industrial scale and, at least, the formulas not approved should be retested / Orientador: Taís Maria Bauab / Coorientador: Ana Dóris de Castro / Banca: Lauro Domingos Moretto / Banca: Hérida Regina Nunes Salgado / Mestre
822

Recalages non-linéaires pour la génération automatique de modèles biomécaniques patients-spécifiques à partir d'imagerie médicale / Non-linear registration for the automatic generation of patient-specific biomechanical models from medical images

Bijar, Ahmad 07 March 2017 (has links)
Les techniques de chirurgie assistée par ordinateur suscitent depuis quelques années un vif intérêt, depuis l’aide au diagnostic jusqu’à l’intervention chirurgicale elle-même, en passant pas les prises de décision. Dans ce but, l’Analyse par Éléments Finis (AEF) du comportement de modèles biomécaniques tridimensionnels est une des méthodes numériques les plus utilisées et les plus efficaces. Cependant, la fiabilité des solutions de l’AEF dépend fortement de la qualité et de la finesse de la représentation des organes sous la forme de maillages d'éléments finis (MEF). Or la génération de tels maillages peut être extrêmement longue et exigeante en ressources computationnelles, car il est nécessaire de procéder à l’extraction précise de la géométrie de l’organe-cible à partir d’images médicales avant de recourir à des algorithmes sophistiqués de maillage. Confrontés à ces enjeux, certains travaux se sont attachés à éviter la procédure de maillage en exploitant des méthodes fondées pour chaque patient sur la déformation géométrique d’un maillage défini sur un sujet de référence, dit « Atlas ». Mais ces méthodes nécessitent toujours une description géométrique précise de l’organe-cible du patient, sous la forme de contours, de modèles surfaciques tridimensionnels ou d’un ensemble de points de référence. Dans ce contexte, le but de la thèse est de développer une méthodologie de conception automatique de maillages « patient-spécifiques », basée sur un Atlas, mais évitant cette étape de segmentation de la géométrie de l’organe-cible du patient. Dans une première partie de la thèse, nous proposons une méthode automatique qui, dans une première phase, procède au recalage volumétrique de l'image anatomique de l’Atlas sur celle du patient, afin d’extraire la transformation géométrique permettant de passer de l’Atlas au patient, puis, dans une seconde phase, déforme le maillage de l’Atlas et l’adapte au patient en lui appliquant cette transformation. Le processus de recalage est conçu de telle manière que la transformation géométrique préserve la régularité et la haute qualité du maillage. L’évaluation de notre méthode, à savoir l'exactitude du processus de recalage inter-sujets, s’est faite en deux étapes. Nous avons d’abord utilisé un ensemble d’images CT de la cage thoracique, en accès libre. Puis nous avons exploité des données IRM de la langue que nous avons recueillies pour deux sujets sains et deux patients souffrant de cancer de la langue, en condition pré- et post-opératoire.Dans une seconde partie, nous développons une nouvelle méthode, toujours basée sur un Atlas, qui exploite à la fois l'information fournie par les images anatomiques et celle relative à la disposition des fibres musculaires telles qu’elle est décrite par imagerie par résonance magnétique du tenseur de diffusion (RM-DT). Cette nouvelle démarche s’appuie ainsi, d’abord sur le recalage anatomique proposé dans notre première méthode, puis sur l’identification et le recalage d’un ensemble de faisceaux de fibres musculaires qui seront ensuite intégrés aux maillages « patient-spécifiques ». Contrairement aux techniques usuelles de recalage d’images RM-DT, qui impliquent pour chaque image la réorientation des tenseurs de diffusion soit au cours de l'estimation de la transformation géométrique, soit après celle-ci, notre technique ne nécessite pas cette réorientation et recale directement les faisceaux de fibres de l’Atlas sur ceux du patient. Notre démarche est très importante, car la détermination et l’identification précises de toutes les sous-structures musculaires nécessiteraient une intervention manuelle pour analyser des milliers, voire des millions, de fibres, qui sont grandement influencées par les limitations et aux distorsions inhérentes aux images RM-DT et aux techniques de tractographie des fibres. L’efficacité de notre méthodologie est démontrée par son évaluation sur un ensemble d’images IRM et RM-DT de la langue d’un sujet. / During the last years, there has been considerable interest in using computer-aided medical design, diagnosis, and decision-making techniques that are rapidly entering the treatment mainstreams. Finite Element Analysis (FEA) of 3D models is one of the most popular and efficient numerical methods that can be utilized for solving complex problems like deformation of soft tissues or orthopedic implant designs/configurations. However, the accuracy of solutions highly depends upon the quality and accuracy of designed Finite Element Meshes (FEMs). The generation of such high-quality subject/patient-specific meshes can be extremely time consuming and labor intensive as the process includes geometry extraction of the target organ and meshing algorithms. In clinical applications where the patient specifiity has to be taken into account via the generation of adapted meshes these problems become methodological bottlenecks. In this context, various studies have addressed these challenges by bypassing the meshing phase by employing atlas-based frameworks using the deformation of an atlas FE mesh. However, these methods still rely on the geometrical description of the target organ, such as contours, 3D surface models, or a set of land-marks.In this context, the aim of this thesis is to investigate how registration techniques can overcome these bottlenecks of atlas-based approaches.We first propose an automatic atlas-based method that includes the volumetric anatomical image registration and the morphing of an atlas FE mesh. The method extracts a 3D transformation by registering the atlas' volumetric image to the subject's one. The subject-specific mesh is then generated by deforming a high-quality atlas FE mesh using the derived transformation. The registration process is designed is such a way to preserve the regularity and the quality of meshes for subsequent FEAs. A first step towards the evaluation of our approach, namely the accuracy of the inter-subject registration process, is provided using a data set of CT ribcage. Then, subject-specific tongue meshes are generated for two healthy subjects and two patients suffering from tongue cancer, in pre- and post-surgery conditions. In order to illustrate a tentative fully automatic process compatible with the clinical constraints, some functional consequences of a tongue surgery are simulated for one of the patients, where the removal of the tumor and the replacement of the corresponding tissues with a passive flap are modeled. With the extraction of any formal priorknowledge on the shape of the target organ and any meshing algorithm, high-quality subject-specific FE meshes are generated while subject’s geometrical properties are successfully captured.Following this method, we develop an original atlas-based approach that employs the information provided by the anatomical images and diffusion tensor imaging (DTI) based muscle fibers for the recognition and registration of fiber-bundles that can be integrated in the subject-specific FE meshes. In contrast to the DT MR images registration techniques that include reorientation of tensors within or after the transformation estimation, our methodology avoids this issue and directly aligns fiber-bundles. This also enables one to handel limited or distorted DTIs by deformation of an atlas fibers’ structure according to the most reliable and non-distorted subject’s ones. Such a manner becomes very important, since the classification and the determination of muscular sub-structures need manual intervention of thousands or millions of fibers for each subject, which are influenced by the limitations associated with the DTI image acquisition process and fiber tractography techniques. To evaluate the performance of our method in the recognition of subject’s fiber-bundles and accordingly in the deformation of the atlas ones, a simulated data set is utilized. In addition, feasibility of our method is demonstrated on acquired human tongue data set.
823

Problém korespondence v úlohách geometrické morfometrie / Correspondence Problem in Geometrics Morphometric Tasks

Krajíček, Václav January 2015 (has links)
Title: Correspondence Problem in Geometric Morphometrics Tasks Author: Václav Krajíček Department / Institute: Department of Software and Computer Science Education Supervisor of the doctoral thesis: RNDr. Josef Pelikán Supervisor's e-mail address: pepca@cgg.mff.cuni.cz Abstract: Shape analysis in physical anthropology, biomedicine, and related disci- plines is mostly done using landmarks or by measuring distances. New techno- logical advancements allow the digitization of object's appearance in the form of triangular meshes or volume images. These digital images are especially beneficial in the cases when landmarks cannot be used to effectively describe the shape. In order to statistically analyze shape in a sample of observations, which are represented by these modalities, correspondence has to be found. Registration is a crucial tool in mapping the shape representations into a common space where correspondence is found by nearest neighbor principle in the case of triangular meshes or by overlaps in the case of volume images. B- spline based non-rigid registration is chosen because of its versatility, relative speed and ability to handle both meshes and volume images. Experiments were also performed with other alternatives - Thin-plate splines and Coherent point drift. The algorithm was modified to handle...
824

On a Divide-and-Conquer Approach for Sensor Network Localization

Sanyal, Rajat January 2017 (has links) (PDF)
Advancement of micro-electro-mechanics and wireless communication have proliferated the deployment of large-scale wireless sensor networks. Due to cost, size and power constraints, at most a few sensor nodes can be equipped with a global positioning system; such nodes (whose positions can be accurately determined) are referred to as anchors. However, one can deter-mine the distance between two nearby sensors using some form of local communication. The problem of computing the positions of the non-anchor nodes from the inter-sensor distances and anchor positions is referred as sensor network localization (SNL). In this dissertation, our aim is to develop an accurate, efficient, and scalable localization algorithm, which can operate both in the presence and absence of anchors. It has been demon-strated in the literature that divide-and-conquer approaches can be used to localize large net-works without compromising the localization accuracy. The core idea with such approaches is to partition the network into overlapping subnetworks, localize each subnetwork using the available distances (and anchor positions), and finally register the subnetworks in a single coordinate system. In this regard, the contributions of this dissertation are as follows: We study the global registration problem and formulate a necessary “rigidity” condition for uniquely recovering the global sensor locations. In particular, we present a method for efficiently testing rigidity, and a heuristic for augmenting the partitioned network to enforce rigidity. We present a mechanism for partitioning the network into smaller subnetworks using cliques. Each clique is efficiently localized using multidimensional scaling. Finally, we use a recently proposed semidefinite program (SDP) to register the localized subnetworks. We develop a scalable ADMM solver for the SDP in question. We present simulation results on random and structured networks to demonstrate the pro-posed methods perform better than state-of-the-art methods in terms of run-time, accuracy, and scalability.
825

Registro automático de superfícies usando spin-image / Automatic surface registration using spin-images

Vieira, Thales Miranda de Almeida 06 February 2007 (has links)
This work describes a method based on three stages for reconstructing a model from a given set of scanned meshes obtained from 3D scanners. Meshes scanned from different scanner s view points have their representation in local coordinate systems. Therefore, for final model reconstruction, an alignment of the meshes is required. The most popular algorithm for cloud data registration is the ICP algorithm. However, ICP requires an initial estimate of mesh alignment, which is, many times, done manually. To automate this process, this work uses a surface representation called spin-images to identify overlap areas between the meshes and to estimate their alignment. After this initial registration, the alignment is refined by the ICP algorithm, and finally the model is reconstructed using a method called VRIP. / Fundação de Amparo a Pesquisa do Estado de Alagoas / Este trabalho descreve um método baseado em três etapas para reconstrução de modelos a partir de malhas capturadas de scanners 3D. Malhas obtidas a partir de diferentes pontos de visão de um scanner têm sua representação em sistemas de coordenadas local. Portanto, para a reconstrução final do modelo, é necessário realizar um alinhamento dessas malhas, ou registro. O algoritmo mais famoso para realizar registro de nuvens de pontos é o algoritmo ICP. Porém, um dos requisitos desse algoritmo é uma estimativa inicial do alinhamento das malhas, que muitas vezes é feita manualmente. Para automatizar esse processo, este trabalho utiliza descritores spin-image para identificar regiões de sobreposição entre as malhas e estimar seus alinhamentos. Após este registro inicial, o alinhamento é refinado através do algoritmo ICP, e finalmente o modelo é reconstruído usando uma técnica chamada VRIP.
826

Os efeitos de sistema de registro de preço nas compras públicas: estudo de caso da Secretaria Municipal de Obras, Serviços Básicos e Habitação da cidade de Manaus

Carvalho, Carlos Henrique Soares January 2008 (has links)
Made available in DSpace on 2009-11-18T18:56:16Z (GMT). No. of bitstreams: 1 csoares.pdf: 727521 bytes, checksum: bc6ee933e50b6ff0ddd2d84322bc1ded (MD5) Previous issue date: 2008 / Public administration has been labeled as inefficient for decades, with society seen it as a great waste of public money with a low generation of results. Its services are notably classified as sluggish, bureaucratic, with a low productivity level and a high incidence of mistakes. In periods of crisis, public administration must be the first to give good examples of balance and parsimony in its expenditures, or it could lead to the failure of the government, in general, causing damages to the population. To reach this goal, some corrective measures must be done, in different directions, by selecting the expenditures and fostering the maximum economy for the exchequer. This is only possible through the application of correct planning techniques, a still far way reality from the culture of our public organisms. One way to this change is the adoption of the Price Registration System, that in the Federal scope was already adopted by the Decree nº 3.931/01, and in the scope of the municipality of Manaus was ordered by the Decree nº 8.270/06. The present study verifies the influence of the use of the Price Registration System in purchases and contracts undertaken by the Local Secretariat of Construction, Basic Services and Housing, in the city of Manaus concerning the economy obtained when compared to other methods of tenders. / Há décadas a administração pública vem sendo rotulada de ineficiente, com grande desperdício de dinheiro público e baixa geração de resultados percebidos pela sociedade. Seus serviços são notoriamente classificados como morosos, burocráticos, com baixo grau de produtividade e alta incidência de erros. Nos momentos de crise, a administração pública deve ser a primeira a dar exemplos de equilíbrio e parcimônia nos seus gastos, sob pena de fracassar o governo, como um todo, causando prejuízo à população. Para atingir esse objetivo, há que se tomarem medidas saneadoras, em diversificadas direções, selecionando as despesas e procurando o máximo de economia para o erário. Isso só é possível mediante a aplicação das corretas técnicas de planejamento, uma realidade ainda distante da cultura de nossos órgãos públicos. Um dos caminhos para essa mudança é a adoção do Sistema de Registro de Preços que, no âmbito federal, já foi adotado pelo Decreto nº 3.931/01, e no âmbito do município de Manaus pelo Decreto nº 8.270/06. Esse estudo verifica a influência da utilização do Sistema de Registro de Preços nas compras e contratações realizadas pela Secretaria Municipal de Obras, Serviços Básicos e Habitação, na cidade de Manaus, no tocante relacionado à economia gerada em comparação às demais modalidades de licitação.
827

A regulação de registro de novas moléculas do setor de defensivos agrícolas

Fonseca, Juliana Munefiça da 22 January 2018 (has links)
Submitted by Juliana Fonseca (juliana-munefica.fonseca@dupont.com) on 2018-02-21T02:54:41Z No. of bitstreams: 1 Dissertação MPAgro 2017_Juliana Fonseca_REVISAO FINAL_OK.docx: 382070 bytes, checksum: dc8820b3cde88b684fd7c352de49671e (MD5) / Rejected by Mayara Costa de Sousa (mayara.sousa@fgv.br), reason: Prezada Juliana, Alguns ajustes a serem feitos de acordo com as normas: 1. O trabalho deve estar em PDF 2. As palavras-chave devem estar separadas por ponto e virgula 3. O trabalho estar sem paginação, por favor verificar as normas ABNT. Qualquer dúvida estou à disposição. Att, Mayara 3799/3438 on 2018-02-23T17:13:37Z (GMT) / Submitted by Juliana Fonseca (juliana-munefica.fonseca@dupont.com) on 2018-02-23T20:18:06Z No. of bitstreams: 1 Dissertação MPAgro 2017_Juliana Fonseca_REVISAO FINAL_23022017 pdf.pdf: 376710 bytes, checksum: 31c2e1617e6c32c5d3689589edfa1abf (MD5) / Approved for entry into archive by Mayara Costa de Sousa (mayara.sousa@fgv.br) on 2018-02-27T17:30:48Z (GMT) No. of bitstreams: 1 Dissertação MPAgro 2017_Juliana Fonseca_REVISAO FINAL_23022017 pdf.pdf: 376710 bytes, checksum: 31c2e1617e6c32c5d3689589edfa1abf (MD5) / Made available in DSpace on 2018-02-27T20:09:24Z (GMT). No. of bitstreams: 1 Dissertação MPAgro 2017_Juliana Fonseca_REVISAO FINAL_23022017 pdf.pdf: 376710 bytes, checksum: 31c2e1617e6c32c5d3689589edfa1abf (MD5) Previous issue date: 2018-01-22 / Esta dissertação busca analisar o comportamento e atuação do MAPA, ANVISA e IBAMA ao longo do processo de registro de uma nova molécula no setor de defensivos agrícolas, com o objetivo de analisar como as atuais aplicações da regulamentação tem afetado a disponibilização destes produtos aos agricultores. A pesquisa utilizou informações de variados sites (órgãos federais, associações, entidades de pesquisa, jornais agrícolas de grande circulação), bem como atas de reuniões, relatórios, planilhas e apresentações dos três órgãos federais. Os dados levantados indicaram uma tendência de aumento no tempo de registro de um novo ingrediente ativo. Esta pesquisa reforça a importância de uma discussão profunda sobre a eficiência na gestão pública e incentivo a inovação no Brasil. É possível notar que houve um grande avanço no segmento de produtos equivalentes, importantes para aumentar a oferta e competividade no setor, no entanto, percebe-se que o cenário atual pode não ser atrativo às empresas que focam em inovação devido a falta de previsibilidade no retorno de seus investimentos. / This research analyzes the behavior and performance of MAPA, ANVISA and IBAMA throughout the process of a new pesticide registration in order to evaluate how the regulation application affect the availability of new products to Brazilian farmers. The research based on information from a variety of websites (federal agencies, associations, entities and agricultural journals), as well as meetings minutes, reports, spreadsheets and presentations from the three federal agencies. The data collected indicated a trend to increase the approval timing of a new active ingredient. The data also indicated the importance of a deep discussion about efficiency in public management and incentive to innovation in Brazil. It is possible to notice that there has been a great advance in the segment of equivalent products, important to increase the supply and competitiveness to benefit growers, however, it is noteworthy that the current scenario may not be attractive to the companies that focus on innovation due to the lack of predictability in the return on investment.
828

A regulamentação sanitária de desenvolvimento e registro de medicamentos no Brasil: inserção no cenário internacional / The sanitary regulation of development and drug registration in Brazil: inclusion in the international arena

Castro, Renata Ribeiro de January 2012 (has links)
Made available in DSpace on 2015-08-19T13:52:55Z (GMT). No. of bitstreams: 2 3.pdf: 1059229 bytes, checksum: 39be1eda6ee4a190cf2e3aaa8add3d0d (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2012 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos/Farmanguinhos. Rio de Janeiro, RJ, Brasil. / O processo de desenvolvimento de um medicamento (PD) é vital para a funcionalidade do insumo farmacêutico ativo (IFA), pois estabelece a forma farmacêutica, a formulação e o processo de produção, viabilizando sua função terapêutica. Cabe pontuar a íntima relação que o PD tem com a etapa de solicitação de registro do medicamento junto à Agência Nacional de Vigilância Sanitária (ANVISA), visto que o mesmo subsidia a produção de lotes piloto, indispensáveis a esta solicitação, e diversas informações necessárias à estruturação documental.Entretanto, ainda que dotado de tais importâncias, em âmbito nacional, o setor regulado não dispõe de qualquer diretriz específica que oriente a condução do PD. Logo, o PD é norteado pelas exigências contidas nas regulamentações direcionadas à solicitação de registro. Esta dissertação objetiva avaliar, para o PD, a extensão da adesão das regulamentações sanitárias, emanadas pela ANVISA, que dispõem sobre a concessão de registro de medicamentos novos, genéricos e similares, atualmente vigentes, com os reques itos internacionais apresentados pela International Conference on Harmonization (ICH). Para tanto, é realizada uma comparação e contextualização por assunto (IFA, excipientes, formulação, processo produtivo, sistema de acondicionamento, atributos microbiológicos e compatibilidade com diluentes de reconstituição) das regulamentações mencionadas, com o Guia da ICH, especificamente, direcionado ao PD –Guia ICH Q8(R2). O princípio do Guia ICH Q8(R2), denominado Qualiy by Design(QbD), usado para a condução do PD, consiste na estruturação do mesmo segundo uma metodologia sistemática, científica, baseada na avaliação do risco, que parte da definição das características ideais de qualidade para o medicamento. Esta estruturação prevê o pleno conhecimento do medicamento, de seu processo de obtenção e controles. Este Guia também fomenta a construção do Design Space (DS), que se estabelece pela avaliação multivariada dos insumos e parâmetros do processo e a influência da variação sobre as características de qualidade do medicamento. Os resultados provenientes da comparação das regulamentações nacionais tratadas nesta dissertação com o Guia ICH Q8(R2), evidenciam que o QbD e a construção do DS não figuram nestas regulamentações. Assim , as divergências entre o Guia ICH Q8(R2) e as regulamentações superam em quantidade e qualidade as coincidências, evidenciando significativo distanciamento, no que tange o PD, entre as regulamentações nacionais de registro considerada se o pensamento internacional, representado pela ICH. / The process of developing a product (PD) is vital to the functionality of the active pharmaceutical ingredient (API), for determining the dosage form, formulation and production process, allowing their therapeutic function. It punctuate the close relationship that the PD has with the step of applying for registration of the drug by Agência Nacional de Vigilância Sanitária(ANVISA -Brazilian equivalent to FDA), since it subsidizes the production of pilot batches, which are essential to this request, and various information necessary for structuring documents. However, although endowed with such sums,the regulated sector has no specific guidelines to conduct of the PD. Therefore, the PD is guided by the requirements contained in regulations aimed at the registration request. This thesis aims to evaluate, for the PD, the extent of adherence of health regulations, issued by ANVISA, which provide for the granting of registration of new drugs, generic and similar currently in force, with the international requisites established by the International Conference on Harmonization (ICH). Therefore,it was done a comparison by subject (API, excipients, formulation, production process, packaging system, microbiological attributes and compatibility with diluents for reconstitution) of the regulations m entioned, with the ICH guide, specifically directed to PD -ICH Q8(R2). The principle of the ICH Q8(R2), called the Quality by Design (QbD), used to drive the PD, consists on scientific systematic methodology and risk assessment based on the definition of ideal drug quality characteristics. This structure provides the knowledge of medicine, of the production process and controls. This guide also encourages the construction of the Design Space (DS), which is established by multivariate assessment of inputs and process parameters and the influence of variation on the product quality.The results from the comparison of national regulations in this dissertation dealt with the Guide ICH Q8(R2), shown that the QBD and construction of the DS are not included in these regulations. Thus, the differences between the Guide ICH Q8(R2) and the regulations exceed in quantity and quality of the matches, showing a significant gap in relation to PD, between the national record and considered international thought, represented by the ICH.
829

Analyse morphométrique 3D de structures anatomiques pour la paléoanthropologie / 3D morphometric analysis of anatomical structures for paleoanthropology

Dumoncel, Jean 06 April 2017 (has links)
L'évolution biologique des organismes peut être étudiée comme une succession de transformations morphologiques qui sont caractérisées par le changement de leur géométrie tridimensionnelle globale et locale. Dans ce contexte, il est nécessaire de développer des outils mathématiques et informatiques comparatifs de formes tridimensionnelles afin d'étudier ces transformations et de pouvoir les comparer avec les variabilités inter- et intra-espèces. Dans la chaîne de traitement des données tridimensionnelles (images 3D ou maillages 3D) employée en " paléoanthropologie virtuelle ", la méthode la plus souvent utilisée en analyse comparative est basée sur des points de repère (en général, anatomiques) dont les coordonnées sont analysées à l'aide d'outils mathématiques tels que la " morphométrie géométrique ". Plus récemment, une autre classe de méthodes a été proposée. Elle permet des comparaisons globales entre les surfaces complètes de structures anatomiques sans avoir besoin de définir des points de repère. On obtient ainsi une analyse statistique de la forme moyenne et de sa variabilité en tout point. Dans cette thèse, nous proposons d'étudier la chaîne d'analyse morphométrique des données 3D utilisées en paléoanthropologie, de la numérisation à l'exploitation des données par les chercheurs. Cette thèse présente des méthodes analytiques pour le traitement des données issues de la paléoanthropologie, depuis la numérisation des sites de fouilles jusqu'à l'acquisition et l'analyse des spécimens. Nous établissons des modèles numériques de terrain (analyses multidimensionnelles de données issues de différentes modalités d'acquisition telles que les scans laser et la photogrammétrie) qui permettent d'appréhender les vestiges dans leur contexte et nous proposons des analyses qui répondent à des problématiques qui sont spécifiques aux études en biologie. En particulier, nous apportons des outils d'analyse et de visualisation (cartographies 3D et analyses statistiques) pour des problématiques de déformation basées sur des recalages surfaciques. Nous proposons également une méthode d'analyse sur des données partielles afin de pouvoir exploiter l'ensemble des données disponibles dans les registres fossiles et modernes. Nos résultats mettent en évidence que les méthodes par recalage surfacique augmentent non seulement les possibilités de capter les formes et leurs variations, mais permettent également de travailler sur des formes globales et non uniquement sur certains points. Nous montrons notamment que ces méthodes permettent le développement d'outils qui sont bien adaptés pour les études en paléoanthropologie. / The biological evolution of organisms can be studied as a set of morphological transformations which are characterized by the modification of their global three- dimensional geometry and by some discrete traits. In this context, it is necessary to develop comparative mathematical and computational tools for the study of the inter- and intraspecific variation. Within the three-dimensional data processing workflow (3D images or 3D meshes) employed in " virtual paleoanthropology ", the method that is most commonly used in comparative analysis is based on landmarks (most often anatomical landmarks) from which coordinates are analyzed by using mathematical tools such as " geometric morphometrics ". More recently, other methods allowing global comparisons between three-dimensional reconstructions without landmarks have been proposed. They allow for example the statistical analysis of a global shape and its variability. We suggest to study the process for morphometric analysis of 3D data commonly used in paleoanthropology, from the digitization to the exploration of 3D data. This dissertation introduces analytical methods for the processing of data provided by paleoanthropological studies, from the digitization of the excavation sites to the acquisition and the analysis of specimens. We established digital ground models (multidimensional analyses of data from various modalities of acquisition such as laser scanner and photogrammetry) that contribute to a comprehensive understanding of fossil remains in their context and we proposed relevant analyses for resolving specific problems inherent to biological studies. In particular, we developed appropriate tools for analyses and viewing (3D mappings and statistical analyses) dedicated specifically to problems of deformation-based registrations. Additionally, we introduced a method for the analysis of partial data in order to use all the specimens available in the fossil and modern records. Besides opening up new possibilities of capturing shape variation, our results highlight that techniques based on surface registration provide a reliable methodological framework for working on global shapes without focusing on specific points. We reported in particular that these methods allow the development of tools which are particularly suitable for the paleoanthropological studies.
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Novas demandas, outros desafios: estudo sobre a implementação da política do patrimônio imaterial no Brasil e seus desdobramentos no processo de inventário, registro e salvaguarda do jongo / New demands, other challenges: study on the implementation of the intangible heritage policy in Brazil and its consequences in the inventory, recording and safeguarding process of registration of jongo

Andréa Rizzotto Falcão 06 December 2011 (has links)
Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro / A questão do patrimônio vem ganhando destaque nos últimos anos, sendo relacionada a temas e universos sociais variados e bastantes distintos. Este trabalho discute um dos aspectos mais recentes das políticas de patrimônio no Brasil, a política de inventário, registro e salvaguarda, instituída pelo Decreto 3.551. A tônica desta pesquisa foi refletir sobre a dinâmica do processo de transformação de determinadas expressões e práticas culturais em "bens patrimoniais", processo caracterizado aqui como a patrimonialização da cultura. O trabalho discute os impasses decorrentes da aplicação e operacionalização da política do patrimônio imaterial tendo como suporte o estudo do processo de inventário, registro e salvaguarda do jongo no Sudeste, realizado pelas equipes de pesquisa do Centro Nacional de Folclore e Cultura Popular CNFCP como parte do Projeto Celebrações e Saberes da Cultura Popular. / The issue of heritage has been gaining attention in recent years, related to diverse and quite distinct topics and social worlds. This paper discusses one of the most recent aspects of the heritage policies in Brazil, ie, the policy of inventory, registration and safeguard, established by Decree 3551, in 2000. The emphasis of this research was to reflect on the dynamics of the transformation of certain expressions and cultural practices in "patrimonial goods", a process characterized here as patrimonialization of culture. The work aims to discuss the impasse arising from the implementation and operationalization of the intangible heritage policy having as support the study of the inventory, registration and safeguard process of the jongo conducted by research teams of the National Center for Folklore and Popular Culture CNFCP, as part of Celebrations and Knowledge of Popular Culture Project.

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