Biologiska läkemedel är stora molekyler som har renats eller producerats från ett biologiskt ursprung. De används idag i stor utsträckning runt om i världen på grund av deras effektivitet att minska symtomen som kan uppstå vid olika mycket svåra sjukdomar. Detta arbete fokuserar på biologiska läkemedel som hämmar cytokinet tumörnekrotisk faktor (TNF). Läkemedlen används bland annat vid svåra autoimmuna sjukdomar. Vid autoimmuna sjukdomar aktiveras cellerna i immunsystemet vilket leder till utsöndring av olika cytokiner till exempel interleukin 1 och TNF. Dessa cytokiner påverkar kroppen på olika sätt genom att aktivera eller inhibera vissa produktionsprocesser i kroppen. Syftet med projektet var att verifiera en cellbaserad metod som används för koncentrationsmätning av det biologiska läkemedlet Infliximab (en TNF antagonist) i patientserum. Metoden som används i detta projekt kallas för reporter gene assay och den baseras på användning av en iLite cellinje. iLite är humana erytroleukemiceller K562 som är transfekterade med nukleär faktor kappa-B. Denna faktor aktiveras när TNF binder sig till TNF receptorer på cellytan. Aktiveringen av denna faktor leder till produktion av enzymet Eldflugeluciferas. Produktionen av enzymet är indirekt proportionell mot koncentrationen av TNF antagonist i serum. Dessutom innehåller cellerna en reporter gen för Renilla luciferas som uttrycks konstant. Renilla luciferas används som en internkontroll för att normalisera variationer som kan orsakas av provhantering samt transfektionseffektivitet. Luminescensen som utvecklas på grund av inverkan av Eldflugeluciferas på luciferas substrat samt inverkan av Renilla luciferas på stopp substrat mäts med hjälp av en luminometer. Dag-till-dag variationen för fem analyserade prov som analyserades vid fyra olika tillfällen var mellan 5 - 28 %, lot-till-lot variationen för fyra prov som analyserades fyra gånger vid fyra olika tillfällen var mellan 14 - 21 %. Alla normala serumprover från friska frivilliga blodgivare var negativa med en koncentration av Infliximab mindre än 0,65 µg/ ml. Resultaten visar att metoden är stabil och känslig jämfört med Biomonitors resultat. Dessutom visar resultaten att medelvärden av de olika körningarna från Euro Diagnostica (ett laboratorium som tillverkar immunologiska kit, Malmö) korrelerar väl med resultaten från Biomonitors laboratorium i Köpenhamn. Korrelationen för 19 analyserade prov var 0,99. / Biological drugs are large molecules that have been purified from or produced from a biological origin. They are used in great extent around the whole world because of their efficiency in reducing the symptoms of very severe diseases. The present work focus on biological drugs that inhibit tumor necrosis factor (TNF). Biological drugs are used for treatment of different autoimmune diseases. In autoimmune diseases activated cells of the immune system leads to secretion of various cytokines such as interleukin 1 and TNF. These cytokines affect the body in different ways by activating or inhibiting certain processes in the body. The purpose of this project was to verify a cell-based method which used for concentration measurement of the biological drug Infliximab (a TNF antagonist) in patient serum. The method which used in this project is called the reporter gene assay, and it is based on the use of an iLite cell line. iLite are human erythroleukemia K562 cells which are transfected with the nuclear factor kappa-B. This factor is activated when the tumor necrosis factor binds to its receptors on the cell surface. The activation of this factor leads to the production of the enzyme Firefly luciferase. Production of the enzyme is indirectly proportional to the concentration of TNF antagonist in the serum. Moreover, the cells contain a reporter gene for Renilla luciferase which is under constant expression. Renilla luciferase is used as an internal control to normalize the variations that may be caused by sample handling and transfection efficiency. The luminescence developed due to the influence of Firefly luciferase on luciferase substrate and Renilla luciferase on stop substrate is measured by using a luminometer. Day-to-day variations for five samples were analyzed at four different times were between 5 - 28 % while variations of lot-to-lot of 4 samples were analyzed at four different times were 14 - 21 %. The concentration of Infliximab in all the serum samples from healthy volunteer blood donors were less than 0.65 µg / ml. The results show that the method is robust and sensitive as compared to Biomonitors results. Furthermore, the results show that the mean value of the different runs from Euro Diagnostica (a laboratory that produces immunological kits, Malmö) for day-to-day and lot-to-lot variation agrees quite well with those from Biomonitors laboratory in Copenhagen. The correlation for the nineteen analyzed samples was 0.99.

In Peru, the coca growers’ movement emerged as a response to the State stance against the proliferation of illicit cultivation of coca leaf. To defend this product, this social movement has appealed mainly to three kinds of actors: pressure groups, political parties and insurgent groups. This article points that, in the exercise of this intermediation, these three actors deploy contradictory discourses and practices, according to the political arenas in which the movement requires navigate to defend the cultivation of the coca leaf. / En Perú, el movimiento cocalero surgió como una respuesta a la postura del Estado en contra de la proliferación de cultivos ilícitos de hoja de coca. Para defender este producto, ha recurrido principalmentea tres tipos de organizaciones para la intermediación política: los grupos de presión a través del gremio cocalero, partidos políticos y los grupos insurgentes. Este artículo muestra que, en el ejercicio de esta intermediación, estos tres actores despliegan discursos y prácticas muchas veces contradictorias, forjando la estructura coyuntural y permeable del movimiento, de acuerdo con el ámbito político en el que el movimiento requiere desplazarse para defender el cultivo de la hoja de coca.

Made available in DSpace on 2016-12-23T14:36:46Z (GMT). No. of bitstreams: 1 Fabiola Xavier Leal.pdf: 3047048 bytes, checksum: d7edc116ccbb5bf78e2a49e4f9fa5b72 (MD5) Previous issue date: 2006-07-25 / As políticas de enfrentamento ao uso indevido de drogas têm se desenvolvido ao longo de 67 anos e nesse contexto, essa Dissertação consiste em um Estudo de Caso sobre os Conselhos Municipais Antidrogas (COMADs) do Estado do Espírito Santo (ES). Tem como objetivos analisar os COMADs buscando identificar como ocorre a formulação da Política Municipal Antidrogas; analisar suas competências e tribuições; identificar e analisar a composição; verificar como a sociedade civil é representada nesses espaços e como ocorre sua participação; identificar e analisar as ações desenvolvidas; verificar se as competências estabelecidas em lei garantem aos COMADs formas de participação ativa na gestão da política antidrogas no município; identificar e analisar as principais estratégias de decisão empregadas nos COMADs. Dos 78 municípios do ES, apenas 26,9% criaram o COMAD estando somente 01 em funcionamento. Foi montada uma listagem contendo 21 Conselhos (sendo que 19 enviaram alguma documentação e/ou informação). Foram realizados contatos telefônicos e visitas aos municípios com Conselho ativo ou inativo. Para a coleta de dados foram utilizadas: pesquisa documental e entrevistas grupal (Grupo Focal) e individual. Para análise dos dados utilizou-se a análise de conteúdo. Os COMADs foram enfocados a partir de sua configuração institucional e das práticas que desenvolvem. A análise foi estruturada em 2 eixos: Processo de Criação; Funcionamento e Manutenção do Conselho. A maioria (68%) surgiu em 2001 e o tempo máximo de funcionamento foi de aproximadamente 3 anos. As funções legalmente estabelecidas a esses órgãos abrangeram 04 campos de ações: Prevenção; Fiscalização e Repressão; Ações normativas para funcionamento do conselho; e Tratamento. Nota-se a não efetivação do caráter deliberativo dos conselhos. O número de componentes dos conselhos variou entre 09 e 39 titulares, sendo a sociedade civil ocupante do maior número de assentos em 05 municípios, apresentando 08 principais entidades sendo a Igreja com maior representação. E a esfera governamental em 14 municípios, possui 13 órgãos representados, sendo as Secretarias de Governo com maior representação. A sociedade civil esteve mais presente as reuniões (54%). A paridade numérica ocorreu em 03 municípios. Identificou-se que o Executivo corresponde a 69% dos representantes seguido pelo Judiciário (17%) e Legislativo (14%). Os temas de pauta mais freqüentes foram: organização do conselho (43%), capacitação/ações de prevenção (26%) e Tratamento (5%). As ações limitaram-se à realização de palestras e eventos municipais de combate às drogas. De um modo geral, os COMADs se configuram como um fenômeno político, institucional, social e cultural, exigindo elaborações teóricas e conceituais, incursões históricas e fundamentações empíricas que têm a ver com as transformações ocorridas nas relações entre Estado e sociedade no país. Os conselhos ainda não conseguiram se desvencilhar das práticas autoritárias e impositivas por parte daqueles que detem o comando. Tem sido desafios para os conselhos a efetiva autonomia, formação continuada dos conselheiros, transformação da pauta em agenda, superação das condições de infra-estrutura, cultura de transparência e de difusão de informações. O que fica é que o processo de formulação e implementação da política oscila entre aquilo que deveria ser e aquilo que efetivamente tem sido / The policies of confrontation to the improper use of drugs have if developed throughout 67 years and of this context, this Dissertation consists of a Study of Case on the City councils Antidrogas (COMADs) of the State of the Espirito Santo (ES). It has as objective to analyze the COMADs searching to identify as the formularization of the Municipal Policies Antidrogas occurs; to analyze its abilities and attributions; to identify and to analyze the composition; to verify as the civil society is represented in these spaces and as its participation occurs; to identify and to analyze the developed actions; to verify if the abilities established in law they guarantee to the COMADs forms of active participation in the management of the policies antidrugs in the city; to identify and to analyze the main used strategies of decision in the COMADs. Of the 78 cities of the ES, only 26.9% had created COMAD being only 01 in functioning. A listing was mounted contends 21 councils (being that they had 19 sent some documentation and/or information). Telephonic contacts and visits to the cities with active or inactive councils had been carried through. For the collection of piece of information they had been used: documentary research and interviews group (Focal Group) and individual. For analysis of the piece of information it was used content analysis. The COMADs had been focused from its institucional configuration and of the practical ones that they develop. The analysis was structuralized in 2 axles: Process of Creation; Functioning and Maintenance of the Council. The majority (68%) appeared in 2001 and the maximum time of functioning was of approximately 3 years. The functions legally established these agencies had enclosed 04 fields of activity: Prevention; Fiscalization and Repression; Normative actions for functioning of the council; e Treatment. It is noticed that the Concil doesn t obtain to accomplish its deliberative character. The number of components of the council varied between 09 and 39 bearers, being the occupying civil society of the biggest number of seats in 05 cities, presenting 08 main entities being the Church with bigger representation. E the governmental sphere in 14 cities, possesss 13 represented agencies, being the Government secretaries with bigger representation. The civil society was more present in the meetings (54%). The numerical parity occurred in 03 cities. It was identified that the Executive corresponds 69% of the representatives followed by Judiciary (17%) and the Legislative one (14%). The more frequent subjects of guideline had been: organization of the council (43%), qualification/ action of prevention (26%) and Treatment (5%). The actions had limited it the accomplishment of lectures and municipal events of combat to the drugs. In a general way, the COMADs if configures as a phenomenon political, institucional, social and cultural, demanding theoretical and conceptual elaborations, historical incursions and empirical recitals that have to see with the occured transformations in the relations between State and society in the country. The council had still not obtained to separate themselves of practical authoritarian and the imposing ones on the part of whom he withholds the command. The effective has been challenges for the council autonomy, continued formation of the council members, transformation of the guideline in agenda, overcoming of the infrastructure conditions, culture of transparency and diffusion of information. What it is is that the process of formularization and implementation of the policies oscillates between what would have to be and what effectively it has been