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La sécurité des médicaments. Législation pharmaceutique européenne et indemnisation des risques médicamenteux. / Drug safety. European pharmaceutical legislation and compensation for the risks linked to medication.Bortoluzzi, Chiara 06 July 2017 (has links)
Un niveau élevé de protection de la santé humaine est assuré dans la définition et la mise en oeuvre de toutes les politiques et actions de l’Union européenne. L’une des politiques les plus importantes, conformément aux enjeux de santé et au développement économique, est celle des médicaments. Leur sécurité est garantie par un cadre juridique donné par une législation pharmaceutique d’envergure présidant à l’octroi de l’autorisation de mise sur le marché et au suivi post-autorisation. Ce cadre juridique est supporté par un dispositif institutionnel d’exception, caractérisé par une interaction étroite entre l’Agence européenne des médicaments, la Commission européenne et les autorités nationales compétentes. Il a récemment été réformé à travers la nouvelle législation de pharmacovigilance. Le concept de sécurité sanitaire est ainsi devenu le principe directeur de la gestion du risque pharmaceutique. Toutefois, lorsque le risque inhérent à tout produit pharmaceutique se manifeste, le dommage médicamenteux se produit ainsi que la demande de réparation. Face à la nécessité d’indemniser les victimes de tels accidents, les réponses nationales des systèmes juridiques français et italien, par les biais de la responsabilité civile de droit commun et de la responsabilité du fait des produits défectueux issue de la directive 85/374/CEE, se révèlent inefficaces, car peu respectueuses de la spécificité du médicament. Ce constat conduit à plaider en faveur d’une dissociation entre responsabilité et indemnisation, en garantissant cette dernière à travers la création d’un fonds d’indemnisation général pour les dommages médicamenteux à participation mixte public-privé. Cette solution garantit une socialisation des risques justifiée par le caractère social du risque thérapeutique. Cela constitue le contrepoids aux dangers inhérents aux innovations de la science, tout en faisant profiter les malades des bénéfices thérapeutiques de demain. En prônant une approche holistique de la politique du médicament, la proposition de ce fonds constitue un instrument d’une politique de santé publique qui ne voit dans l’indemnisation des risques médicamenteux qu’un complément et un prolongement de la garantie de sécurité à la base de la législation pharmaceutique européenne. / The definition and implementation of the European Union’s policies and activities guarantee a very high level of human health protection. One of its most important policies, in accordance with the relative health and economic development issues, is that on medicinal products. Drug safety is guaranteed by a legal framework, constructed on the pharmaceutical legislation laying down rules and procedures for obtaining marketing authorisation and for post authorisation monitoring. This legal framework is supported by a special institutional system,which in particular ensures close interaction between the European Medicines Agency, the European Commission and the national competent authorities. This legal framework has recently been revised as a result of the new pharmacovigilance legislation. As such, health safety has become a key directive in managing pharmaceutical risk. Yet, whenever a risk relating directly to a particular pharmaceutical product becomes apparent, medical damages and compensation claims arise. The response of the national French and Italian legal systems to the application for compensation of the victims of such accidents, by way of the ordinary rules of civil liability and the liability for defective products as defined in Council Directive85/374/EEC, has proven ineffective: they fail to take into account the specific nature ofpharmaceutical products. Based on this observation, there is a sound case for separating liability from compensation: the latter can be guaranteed by setting up a general compensationfund for medical damages, with both public and private sector participation. This solutionwould guarantee a socialisation of risks that is justified by the social nature of therapeutic risk. It would provide a counterbalance to the dangers inherent in scientific innovation, whilst simultaneously allowing patients to benefit from future therapeutic developments. By advocating a holistic approach to drug policy, this proposed compensation fund would act as apublic health policy instrument, in the context of which compensation for medical risks would only be considered an addition to, and extension of, the security guarantee that constitutes the cornerstone of the European pharmaceutical legislation.
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Maila-go-fenywa, Rangwato Magoro and Mmino wa Kosa: some perspectives on theory and practiceMasoga, Mogomme Alpheus 25 August 2009 (has links)
Looking at current African music studies, one notices an interesting shift from the `norm' to a fresh engagement and analysis. Fresh perspectives are increasingly being presented to position African music dialogue in the arena of the so-called `established music fields'. While these developments are noticeable, the unmentioned, unsung and uncelebrated indigenous African music practitioners, composers, performers, poets, praise singers and so forth must not be forgotten. This work does not claim novelty in terms of the latter gap, but takes the debate further to highlight, though in a small way, such a need. Mme Rangwato Magoro, from Malatane village in the greater Ga-Seloane community, is included as the main research collaborator in this brief piece of work. The work may come as a shock to any established researcher in music and music science. The author could not help but attempt to allow the voice of Mme Magoro to determine the format and content of this piece of work. In addition, the Maila-go-fenywa performance group is linked with the compositional and performance work and the praise poems of Mme Magoro. In conclusion, discussions and debates on musical arts education are addressed in terms of implementation, with examples drawn from the work of Maila-go-fenywa. / Art History, Visual Arts & Musicology / M.A. (Musicology)
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Employees' adherence to the Occupational Health and Safety Act in the steel manufacturing sectorMojapelo, Jerry 09 1900 (has links)
M. Tech. (Labour Relations Management, Faculty of Management Sciences), Vaal University of Technology. / Industrial accidents have proved to be more prevalent and costly than anticipated especially in developing countries including South Africa. Occupational accidents have direct and indirect cost implications for an organisation as well as society. Governments in many countries have tried to implement legislation to try and curb the scourge of industrial accidents. The primary purpose of this research was to investigate the level of employee adherence to the Occupational, Health and Safety Act (OHSA) 85 of 1993 in the steel manufacturing sector. This research provided an overview of various factors that influences employee’s level of understanding and adherence to the OHSA. This included factors such as information and training in health and safety; employee safety perception, employee safety awareness, employee safety adherence, employee behaviour with regard to health and safety, the role of the union in health and safety issues, accident reporting mechanism, and employee’s perceptions of the influence of rewards on health and safety. A structured questionnaire consisting of closed-ended questions was developed and disseminated in order to gather relevant data. Given the scale of the research, a quantitative research method was implemented. The population for the study strictly consisted of employees working in the steel manufacturing sector. A purposive sampling technique was selected. Statistical Package for Social Sciences 22.0 (SPSS) was used to analyse the data. The sample size of (n) =165 employees was involved in the study. The response rate for the total was (98.5%). Descriptive, frequency, correlation, regression and means analysis was employed in this study. The results of the study indicated that majority of the employees were aware and adhered with the requirements of the OHSA with the organisation.
It was suggested that strong stake holder partnerships between unions, employers and employees be formulated. The state should reinforce the Department of Labour inspectorate by giving it more powers to be able to execute its task meritoriously and efficiently. It further suggested that the state must rapidly focus on recruiting and training more health and safety labour inspectors to ensure appropriate enforcement of health and safety regulations. Lastly it is advisable to create and engrave a health and safety culture within the organisation that focuses on highly on employee involvement and mutual trust. The proposed recommendation for the study, limitations and the conclusion of the study were outlined in Chapter 5.
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Emissão de gases de efeito estufa em solo cultivado com pastagem (Tifton 85) e irrigado com efluente de esgoto tratado / Emission of greenhouse gases from soil cultived with pasture (Tifton 85) and irrigated with treated sewage effluentSantin, Roberta Clemente 21 June 2012 (has links)
Atualmente, os maiores desafios para a humanidade são a iminente escassez de água, o aumento da produção de alimentos e a busca de fontes alternativas de energia. O uso de efluentes de esgoto tratado (EET) para irrigação agrícola pode, além de fornecer água, nutrientes e matéria orgânica para produção agrícola, minimizar o impacto ambiental causado pela sua disposição nos corpos dágua e aumentar a disponibilidade de água para outros fins. Pode ainda, aumentar a produção agrícola em uma mesma área, conservando as áreas florestadas, reduzir as despesas do agricultor com fertilizantes nitrogenados, e atuar na redução dos gases de efeito estufa na atmosfera, pela maior produção de biomassa e pelo acúmulo de carbono no solo através da rizodeposição e deposição de resíduos vegetais. Apesar desses aspectos favoráveis, esta prática interfere no sistema soloplanta- água modificando as entradas e saídas de carbono e nitrogênio de seus diferentes reservatórios Até o presente momento, pouco foi investigado sobre os efeitos da irrigação com esgoto tratado nas emissões de CH4, CO2 e N2O pelo solo. Desta forma, o presente trabalho teve como objetivo principal quantificar as emissões de CO2, CH4 e N2O, por meio do estudo de um Argissolo Vermelho Distrófico Latossólico, cultivado com capim Tifton 85 e irrigado com efluente de esgoto tratado produzido por tratamento biológico do esgoto do Município de Lins, SP. Tem ainda como objetivo avaliar mudanças ocorridas na química do solo em relação as concentrações de sódio, carbono e nitrogênio e a produtividade da capim. As principais conclusões foram que (i) o capim Tifton 85 foi mais produtivo nos tratamentos que receberam irrigação com EET, quando comparados àqueles irrigados com água; (ii) a concentração de Na no solo apresentou um aumento significativo independente do tipo de irrigação utilizada (EET ou água); (iii) a irrigação com EET contribuiu para elevar as concentrações de carbono e nitrogênio no solo; (iv) as emissões de N2O e CO2 dependem predominantemente da umidade do solo, da temperatura e das quantidades de fertilizantes nitrogenado mineral aplicados e menos do tipo de água utilizada na irrigação; (v) o CH4 foi o único que não apresentou relação direta de suas emissões com a sazonalidade climática; (vi) as emissões de CO2, N2O e CH4 pelos solos irrigados com EET não diferem de pastagens não irrigadas ou irrigadas com água, sendo mais influenciadas pelas práticas de manejo. Os resultados indicam que a irrigação de culturas com EET é uma pratica sustentável. / Nowadays, the humanity is faced with great challenges such as the impending water shortage, the increase in food production or the search for alternative energy sources. The use of treated sewage effluent (TSE) as water and/or nutrient source for agricultural irrigation, can preserve existing water resources by minimising environmental impacts caused by its discharge to surface waters and increase water availability for other purposes. Moreover, wastewater use can contribute to increase agricultural production, preserving forested areas; reduce costs for nitrogen fertilization, and can diminish greenhouse gas emissions to the atmosphere due to higher biomass production and carbon accumulation in soil through root and plant residue deposition. Despite these favorable aspects, this practice interferes in the soil-plant-water system by modifying the inputs and outputs of carbon and nitrogen from their different pools. Thus, this study aimed at quantifying CO2, CH4 and N2O emissions from a Typic Haplustox cropped with Tifton 85 and irrigated with treated sewage effluent from the wastewater treatment plant (anaerobic and facultative ponds) at the city of Lins, SP and evaluates moreover changes in soil chemistry related to sodium, carbon and nitrogen concentrations and grass productivity. The study revealed that: (i) Tifton-85 was more productive at in treatments with TSE irrigation, compared to potable water irrigation, (ii) the Na concentration in the soil increased significantly regardless of the type of irrigation used (TSE or potable water), (iii) TSE irrigation increased the carbon and nitrogen concentrations in soil, (iv) N2O and CO2 emissions were predominantly dependent on soil moisture, temperature and the quantities of mineral nitrogen fertilizers applied as from the type of water used for irrigation, (v) only CH4 emissions had no direct relation to climate seasonality, and (vi) CO2, N2O and CH4 emissions of TSE irrigated soils did not differ from not irrigated or water irrigated pastures, being mainly affected by different management practices. The results indicate that crop irrigation with TSE can represent is a sustainable agricultural practice.
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Maillages hex-dominants : génération, simulation et évaluation / Hex-dominant meshes : generation, simulation and evaluationReberol, Maxence 23 March 2018 (has links)
Cette thèse s'intéresse à la génération, à l'utilisation et à l'évaluation des maillages hex-dominants, composés d'hexaèdres et de tétraèdres, dans la cadre de la simulation numérique par la méthode des éléments finis. Les éléments finis hexaédriques sont souvent préférés aux éléments tétraédriques car ils offrent un meilleur ratio entre précision et temps de calcul dans un certain nombre de situations. Cependant, si la génération automatique de maillages tétraédriques est aujourd'hui un domaine bien maîtrisé, ce n'est pas le cas de la génération de maillages hexaédriques alignés avec le bord, qui reste un problème largement ouvert. En l'absence de progrès significatifs, les approches actuelles se contentent de maillages hex-dominants afin de tirer parti des performances supérieures des hexaèdres et de la flexibilité géométrique des tétraèdres, qui rend possible le maillage automatique. Dans une première partie, nous développons des algorithmes robustes pour la génération de maillages hex-dominants à partir de champs de directions, notamment pour l'isolement et le remplissage des régions difficiles à mailler (singularités et autres dégénérescences). Dans la seconde partie, nous essayons de déterminer dans quelles situations et dans quelle mesure les maillages hexaédriques, et hex-dominants générés précédemment, sont plus intéressants que les maillages tétraédriques. Ceci implique spécifiquement d'étudier plusieurs manières d'effectuer des simulations par éléments finis avec les maillages hybrides, dont une approche où nous utilisons des contraintes de continuité pour maillages non-conformes. Pour mesurer l'influence du maillage sur l'approximation des solutions, nous proposons une nouvelle méthode d'échantillonnage pour calculer très efficacement des distances globales entre solutions éléments finis définies sur des domaines compliqués / This thesis focuses on generation, usage and evaluation of hex-dominant meshes, which are made of hexaehedra and tetrahedra, in the context of the finite element method. Hexahedron finite elements are often preferred to tetrahedron elements because they offer a better compromise between accuracy and computation time in certain situations. However, if tetrahedral meshing is a well mastered subject, it is not the case of hexahedral meshing. Generating hexahedral meshes with elements aligned to the borders is still an open and difficult problem. Meanwhile, current automated approaches can use hex-dominant meshes in order to take advantage of both hexahedron accuracy and geometrical flexibility of tetrahedra. In the first part, we develop robust algorithms for the generation of hex-dominant meshes with elements aligned with the borders. Specifically, we propose a method to extract and fill the areas where hexahedral meshing is difficult (singularities and degeneracies). In the second part, we try to identify and to quantify the advantages of hexahedral and hex-dominant meshes over tetrehedral ones. This requires to study various ways to apply the finite element method on hybrid meshes, including one in which we propose to use continuity constraints on hexahedral-tetrahedral non-conforming meshes. To measure the impact of meshes on the finite element accuracy, we develop a new sampling method which allows to compute efficiently global distances between finite element solutions defined on complicated 3D domains
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Emissão de gases de efeito estufa em solo cultivado com pastagem (Tifton 85) e irrigado com efluente de esgoto tratado / Emission of greenhouse gases from soil cultived with pasture (Tifton 85) and irrigated with treated sewage effluentRoberta Clemente Santin 21 June 2012 (has links)
Atualmente, os maiores desafios para a humanidade são a iminente escassez de água, o aumento da produção de alimentos e a busca de fontes alternativas de energia. O uso de efluentes de esgoto tratado (EET) para irrigação agrícola pode, além de fornecer água, nutrientes e matéria orgânica para produção agrícola, minimizar o impacto ambiental causado pela sua disposição nos corpos dágua e aumentar a disponibilidade de água para outros fins. Pode ainda, aumentar a produção agrícola em uma mesma área, conservando as áreas florestadas, reduzir as despesas do agricultor com fertilizantes nitrogenados, e atuar na redução dos gases de efeito estufa na atmosfera, pela maior produção de biomassa e pelo acúmulo de carbono no solo através da rizodeposição e deposição de resíduos vegetais. Apesar desses aspectos favoráveis, esta prática interfere no sistema soloplanta- água modificando as entradas e saídas de carbono e nitrogênio de seus diferentes reservatórios Até o presente momento, pouco foi investigado sobre os efeitos da irrigação com esgoto tratado nas emissões de CH4, CO2 e N2O pelo solo. Desta forma, o presente trabalho teve como objetivo principal quantificar as emissões de CO2, CH4 e N2O, por meio do estudo de um Argissolo Vermelho Distrófico Latossólico, cultivado com capim Tifton 85 e irrigado com efluente de esgoto tratado produzido por tratamento biológico do esgoto do Município de Lins, SP. Tem ainda como objetivo avaliar mudanças ocorridas na química do solo em relação as concentrações de sódio, carbono e nitrogênio e a produtividade da capim. As principais conclusões foram que (i) o capim Tifton 85 foi mais produtivo nos tratamentos que receberam irrigação com EET, quando comparados àqueles irrigados com água; (ii) a concentração de Na no solo apresentou um aumento significativo independente do tipo de irrigação utilizada (EET ou água); (iii) a irrigação com EET contribuiu para elevar as concentrações de carbono e nitrogênio no solo; (iv) as emissões de N2O e CO2 dependem predominantemente da umidade do solo, da temperatura e das quantidades de fertilizantes nitrogenado mineral aplicados e menos do tipo de água utilizada na irrigação; (v) o CH4 foi o único que não apresentou relação direta de suas emissões com a sazonalidade climática; (vi) as emissões de CO2, N2O e CH4 pelos solos irrigados com EET não diferem de pastagens não irrigadas ou irrigadas com água, sendo mais influenciadas pelas práticas de manejo. Os resultados indicam que a irrigação de culturas com EET é uma pratica sustentável. / Nowadays, the humanity is faced with great challenges such as the impending water shortage, the increase in food production or the search for alternative energy sources. The use of treated sewage effluent (TSE) as water and/or nutrient source for agricultural irrigation, can preserve existing water resources by minimising environmental impacts caused by its discharge to surface waters and increase water availability for other purposes. Moreover, wastewater use can contribute to increase agricultural production, preserving forested areas; reduce costs for nitrogen fertilization, and can diminish greenhouse gas emissions to the atmosphere due to higher biomass production and carbon accumulation in soil through root and plant residue deposition. Despite these favorable aspects, this practice interferes in the soil-plant-water system by modifying the inputs and outputs of carbon and nitrogen from their different pools. Thus, this study aimed at quantifying CO2, CH4 and N2O emissions from a Typic Haplustox cropped with Tifton 85 and irrigated with treated sewage effluent from the wastewater treatment plant (anaerobic and facultative ponds) at the city of Lins, SP and evaluates moreover changes in soil chemistry related to sodium, carbon and nitrogen concentrations and grass productivity. The study revealed that: (i) Tifton-85 was more productive at in treatments with TSE irrigation, compared to potable water irrigation, (ii) the Na concentration in the soil increased significantly regardless of the type of irrigation used (TSE or potable water), (iii) TSE irrigation increased the carbon and nitrogen concentrations in soil, (iv) N2O and CO2 emissions were predominantly dependent on soil moisture, temperature and the quantities of mineral nitrogen fertilizers applied as from the type of water used for irrigation, (v) only CH4 emissions had no direct relation to climate seasonality, and (vi) CO2, N2O and CH4 emissions of TSE irrigated soils did not differ from not irrigated or water irrigated pastures, being mainly affected by different management practices. The results indicate that crop irrigation with TSE can represent is a sustainable agricultural practice.
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A profile of changes in vehicle characteristics following the I-85 HOV-to-HOT conversionDuarte, David 15 April 2013 (has links)
A 15.5-mile portion of the I-85 high-occupancy vehicle (HOV) lane in the metropolitan area of Atlanta, GA was converted to a high-occupancy toll (HOT) lane as part of a federal demonstration project designed to provide a reliable travel option through this congested corridor. Results from the I-85 demonstration project provided insight into the results that may follow the Georgia Department of Transportation's planned implementation of a $16 billion HOT lane network along metropolitan Atlanta's other major roadways [2]. To evaluate the impacts of the conversion, it was necessary to measure changes in corridor travel speed, reliability, vehicle throughput, passenger throughput, lane weaving, and user demographics. To measure such performance, a monitoring project, led by the Georgia Institute of Technology collected various forms of data through on-site field deployments, GDOT video, and cooperation from the State Road and Toll Authority (SRTA). Changes in the HOT lane's speed, reliability or other performance measure can affect the demographic and vehicle characteristics of those who utilize the corridor. The purpose of this particular study was to analyze the changes to the vehicle characteristics by comparing vehicle occupancy, vehicle classifications, and vehicle registration data to their counterparts from before the HOV-to-HOT conversion.
As part of the monitoring project, the Georgia Tech research team organized a two-year deployment effort to collect data along the corridor during morning and afternoon peak hours. One year of data collection occurred before the conversion date to establish a control and a basis from which to compare any changes. The second year of data collection occurred after the conversion to track those changes and observe the progress of the lane's performance. While on-site, researchers collected data elements including visually-observed vehicle occupancy, license plate numbers, and vehicle classification [25]. The research team obtained vehicle records by submitting the license plate tag entries to a registration database [26]. In previous work, vehicle occupancy data were collected independently of license plate records used to establish the commuter shed. For the analyses reported in this thesis, license plate data and occupancy data were collected concurrently, providing a link between occupancy records of specific vehicles and relevant demographic characteristics based upon census data. The vehicle records also provided characteristics of the users' vehicles (light-duty vehicle vs. sport utility vehicle, model year, etc.) that the researchers aggregated to identify general trends in fleet characteristics.
The analysis reported in this thesis focuses on identifying changes in vehicle characteristics that resulted from the HOV-to-HOT conversion. The data collected from post-conversion are compared to pre-conversion data, revealing changes in vehicle characteristics and occupancy distributions that most likely resulted from the implementation of the HOT lane. Plausible reasons affecting the vehicle characteristics alterations will be identified and further demographic research will enhance the data currently available to better pinpoint the cause and effect relationship between implementation and the current status of the I-85 corridor.
Preliminary data collection outliers were identified by using vehicle occupancy data. However, future analysis will reveal the degree of their impact on the project as a whole. Matched occupancy and license plate data revealed vehicle characteristics for HOT lane users as well as indications that the tested data collectors are predominantly synchronized when concurrently collecting data, resulting in an argument to uphold the validity of the data collection methods.
Chapter two provides reasons for why HOT lanes were sought out to replace I-85's HOV lanes. Chapter two will also provide many details regarding how the HOT lanes function and it will describe the role the Georgia Institute of Technology played in the assessment the HOV-to-HOT conversion. Chapter three includes the methodologies used to complete this document while chapter four provides results and analysis for the one year period before the conversion and the one year period after the conversion.
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Rethinking downtown highwaysLaRoche, Lealan Dorothy Marie 21 December 2010 (has links)
Freeways have had a strong influence not only on the urban transportation but also on downtown areas both physically and socially. Certainly, they have extended the commuting limits of the city and made lower land costs more accessible. However, many of the mid-century freeways, once championed by planners as tools for urban renewal, have created swaths of blight through city neighborhoods. Their negative impacts on the larger urban framework requires new ideas for healthier alternatives to aid in preserving and building sustainable cities.
Removal of any downtown highway requires careful thought— even more consideration than when it was built. Quick solutions are what resulted in the problems that downtown highways of the Interstate-Era have today. If it is the simple interactions between people and place are that make up the positive aspects an urban environment, then what are the possibilities and strategies for removing urban highway, which are one of the primary impediments separating people in place in contemporary cities? This question is the focus of this thesis.
At its core, the removal of freeways represents a trade-off between mobility objectives and economic development objectives. Evidence from other cities’ decisions to redesign or remove their downtown highways suggests multiple benefits. Making design changes, such as to replace a downtown highway with a well-designed surface boulevard, can stimulate economic activities without necessarily causing traffic chaos.
Solutions come in different shapes and sizes. The selected case studies in this thesis reflect a diversity of approaches – suggesting no single strategy exists for addressing downtown highway issues. This reflects the fact that multiple alternatives must be considered in every situation because each approach varies in costs and opportunities. A typology of highway alternations derived from the case studies includes seven different techniques: burying, demolishing, taming, capping or bridging, elevating, retaining, and relocating. The final chapter applies the conclusions from the case studies to the Downtown Connector– Interstate 75/85– in Downtown Atlanta, Georgia.
Urban design and transportation planning has an emerging new set of values. Transportation planning is seeking to promote alternate modes of transportation to the private vehicle, like transit, by foot, or by bicycle. We now understand that connectivity is not served only by highways but also by urban street networks that invite modes other than just automobiles. An important role for urban design will be to shape the way these interactions are made to benefit the citizens, its urban spaces, and the economy.
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Analysis of the Development Options to Improve the Income Situation of Dairying Households in Punjab / Analysis of the Development Options to Improve the Income Situation of Dairying Households in PunjabMahmood, Khalid 13 May 2008 (has links)
No description available.
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Developing Controlling and Performance Evaluation of Multinational Companies Operating in Egypt / Entwicklung des Controllings und die leistungsbewertung der multinationalen Firmen, die in Ägypten operierenElsharawy, Hatem 11 September 2006 (has links)
No description available.
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