Os ensaios clínicos ocorrem cada vez mais em uma escala global e as pesquisas patrocinadas vem mudando para as regiões emergentes. A condução desses estudos traz benefícios para centros de pesquisa, pacientes e para o país como um todo. No entanto, a alocação de ensaios clínicos por companhias farmacêuticas multinacionais é um processo complexo determinado por múltiplos fatores e o conhecimento de quais fatores as companhias farmacêuticas valorizam mais ao alocar ensaios clínicos é escasso. Assim, compreender melhor esse processo é essencial para governos e centros de pesquisa que desejam atrair mais ensaios clínicos patrocinados por companhias farmacêuticas multinacionais. O objetivo deste trabalho é apresentar os atributos de centros de pesquisa clínica necessários para melhorar a captação de estudos clínicos patrocinados. Para identificar os fatores considerados determinantes da seleção de centros de pesquisa por patrocinadores e organizações representativas de pesquisa clínica foi desenvolvido um estudo descritivo-exploratório por meio da revisão da literatura através de buscas em bases de dados. As buscas resultaram na seleção de 16 materiais bibliográficos que abordaram a questão seleção de centros de pesquisa. Os fatores considerados mais críticos para a seleção foram disponibilidade de população alvo e capacidade de recrutamento, tempo de start-up e interesse e motivação da equipe do centro. Além disso, a infraestrutura é considerada um pré-requisito que pode inviabilizar a seleção e a qualidade de dados também é muito valorizada. Os custos diretos de execução do ensaio não foram considerados muito importantes, ao contrário dos custos indiretos. A partir do conhecimento dos pré-requisitos e dos fatores determinantes da seleção de um centro para um ensaio clínico multicêntrico patrocinado por companhias farmacêuticas, a Empresa Brasileira de Serviços Hospitalares poderá promover e direcionar os esforços para organizar uma rede de centros de pesquisa que pode ser muito atrativa. / Clinical trials are increasingly occurring on a global scale and sponsored research has been shifting to emerging regions. Conducting these studies brings benefits to research centers, patients, and the country as a whole. However, the allocation of clinical trials by multinational pharmaceutical companies is a complex process determined by multiple factors and the knowledge of what factors pharmaceutical companies value most when allocating clinical trials is scarce. So, better understanding this process is essential for governments and research centers wishing to attract more clinical trials sponsored by multinational pharmaceutical companies. The objective of this work is to present the attributes of clinical research centers necessary to improve the capture of sponsored clinical studies. To identify the factors considered as determinants of the selection of research centers by sponsors and clinical research organizations, a descriptive-exploratory study was developed through the review of the literature through searches in databases. The search resulted in the selection of 16 bibliographic materials that addressed the issue of selection of research centers. The factors considered most critical for center selection were target population availability and recruiting capacity, start-up time, and interest and motivation of the center staff. In addition, infrastructure is considered a prerequisite that can make selection unfeasible and data quality is also highly valued. The direct costs of running the trial were not considered very important, as opposed to indirect costs. From the knowledge of the prerequisites and determinants of the selection of a center for a multi-center clinical trial sponsored by pharmaceutical companies, the Empresa Brasileira de Serviços Hospitalares can promote and direct efforts to organize a network of research centers that can be very attractive.

Made available in DSpace on 2016-03-15T14:17:05Z (GMT). No. of bitstreams: 2 5.pdf: 731938 bytes, checksum: 10ae8cfa98b79462e48442ff66508e04 (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2015 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos/Farmanguinhos. Rio de Janeiro, RJ, Brasil. / O bom emprego de recursos na pesquisa e desenvolvimento (P&D) pode possibilitar o tratamento dos indivíduos com novos medicamentos, como os fitoterápicos. O objetivo foi estimar custo das atividades da fase Fitoquímica de um projeto de pesquisa e desenvolvimento de um medicamento à base de uma espécie vegetal. O recorte das atividades da fase Fitoquímica permitiu acesso aos dados dos processos de extração, fracionamento e isolamento. A seguir, foram coletadas todas as informações que possibilitavam o cálculo do custo da pesquisa, sendo organizadas para a obtenção dos custos da matéria prima por unidade, o valor do homem/hora, o preço dos equipamentos e a depreciação dos mesmos. Com base nestas informações foi possível calcular os seguintes custos parciais: Materiais, MOD (mão de obra direta) e Custo Total dos Equipamentos (Depreciação). O emprego do modelo de custeio variável sugeriu as seguintes considerações: a mão de obra direta representou a maior participação entre os custos apurados (73,9%), indicando que o tempo de execução das tarefas tem impacto no custo total da Fitoquímica. O emprego do modelo de organização e apuração dos custos como referência de comparação e análise; estudos semelhantes podem ser aplicados para a obtenção dos custos das demais atividades para cada fase do projeto de P&D de modo a se chegar aos valores totais; o presente trabalho permitiu a elaboração de equações algébricas para representar o processo de aferição dos custos das atividades, possibilitando uma orientação para a padronização do cálculo. / The good use of resources in research and development (R & D) may enable the treatment of patients with new medicines, such as herbal medicines. The goal was to estimate the cost of the activities of Phytochemistry phase of a research project and development of a drug based on a plant species. The clipping of the activities of Phytochemistry phase allowed access to the data extraction processes, fractionation and isolation. Next, we collected all the information that enabled the calculation of the cost of research, obtaining the costs of raw materials per unit, the value of man / hour, the price of the equipment and of their depreciation. Based on this information it was possible to calculate the following partial costs: materials, MOD (direct labor) and Total Cost of equipment (depreciation). The use of variable cost model suggested the following considerations: the direct labor accounted for the largest share among the calculated costs (73.9%), indicating that the runtime of tasks impacts the total cost of Phytochemistry. The use of variable cost model made it possible to establish a criterion for the collection of information, organization and determination of costs as compared to reference and analysis; similar studies can be applied to obtain the costs of other activities for each phase of the project R & D in order to reach the total amounts; this work has enabled the development of algebraic equations to represent the process of benchmarking of the activities costs, providing guidance to standardize the calculation.

Os ensaios clínicos ocorrem cada vez mais em uma escala global e as pesquisas patrocinadas vem mudando para as regiões emergentes. A condução desses estudos traz benefícios para centros de pesquisa, pacientes e para o país como um todo. No entanto, a alocação de ensaios clínicos por companhias farmacêuticas multinacionais é um processo complexo determinado por múltiplos fatores e o conhecimento de quais fatores as companhias farmacêuticas valorizam mais ao alocar ensaios clínicos é escasso. Assim, compreender melhor esse processo é essencial para governos e centros de pesquisa que desejam atrair mais ensaios clínicos patrocinados por companhias farmacêuticas multinacionais. O objetivo deste trabalho é apresentar os atributos de centros de pesquisa clínica necessários para melhorar a captação de estudos clínicos patrocinados. Para identificar os fatores considerados determinantes da seleção de centros de pesquisa por patrocinadores e organizações representativas de pesquisa clínica foi desenvolvido um estudo descritivo-exploratório por meio da revisão da literatura através de buscas em bases de dados. As buscas resultaram na seleção de 16 materiais bibliográficos que abordaram a questão seleção de centros de pesquisa. Os fatores considerados mais críticos para a seleção foram disponibilidade de população alvo e capacidade de recrutamento, tempo de start-up e interesse e motivação da equipe do centro. Além disso, a infraestrutura é considerada um pré-requisito que pode inviabilizar a seleção e a qualidade de dados também é muito valorizada. Os custos diretos de execução do ensaio não foram considerados muito importantes, ao contrário dos custos indiretos. A partir do conhecimento dos pré-requisitos e dos fatores determinantes da seleção de um centro para um ensaio clínico multicêntrico patrocinado por companhias farmacêuticas, a Empresa Brasileira de Serviços Hospitalares poderá promover e direcionar os esforços para organizar uma rede de centros de pesquisa que pode ser muito atrativa. / Clinical trials are increasingly occurring on a global scale and sponsored research has been shifting to emerging regions. Conducting these studies brings benefits to research centers, patients, and the country as a whole. However, the allocation of clinical trials by multinational pharmaceutical companies is a complex process determined by multiple factors and the knowledge of what factors pharmaceutical companies value most when allocating clinical trials is scarce. So, better understanding this process is essential for governments and research centers wishing to attract more clinical trials sponsored by multinational pharmaceutical companies. The objective of this work is to present the attributes of clinical research centers necessary to improve the capture of sponsored clinical studies. To identify the factors considered as determinants of the selection of research centers by sponsors and clinical research organizations, a descriptive-exploratory study was developed through the review of the literature through searches in databases. The search resulted in the selection of 16 bibliographic materials that addressed the issue of selection of research centers. The factors considered most critical for center selection were target population availability and recruiting capacity, start-up time, and interest and motivation of the center staff. In addition, infrastructure is considered a prerequisite that can make selection unfeasible and data quality is also highly valued. The direct costs of running the trial were not considered very important, as opposed to indirect costs. From the knowledge of the prerequisites and determinants of the selection of a center for a multi-center clinical trial sponsored by pharmaceutical companies, the Empresa Brasileira de Serviços Hospitalares can promote and direct efforts to organize a network of research centers that can be very attractive.

[pt] Pensar o espaço urbano da cidade do Rio de Janeiro remete, num primeiro momento, a pensamentos de violência e medo. Destarte essa cidade vem assistindo a um forte e intenso processo de fragmentação de seu tecido sociopolítico-espacial. Compondo esse violento cenário emergem as facções criminosas de compra e venda de entorpecentes, que dominam grande parte das favelas cariocas, as forças do estado, via de regra apenas o braço policial, e a população comum que assiste abismada e amedrontada, a intensos conflitos armados, mormente a população localizada em favelas. O poderio sociopolítico-econômico alcançado pelas facções criminosas na metrópole do Rio de Janeiro é bastante influente, a ponto de se tornar legitimado nas unidades de internação de jovens infratores e nas unidades prisionais de adultos. Dessa forma esses locais de clausura em associação com as favelas se configuram em territórios de intensa disputa política e bélica, assumindo papel crucial no desenrolar da dinâmica cotidiana da cidade. Essa correlação é percebida e analisada através de um estudo transescalar, que permite enxergar o espaço não só em sua feição territorial - de contenção, de cárcere - mas também sob a forma de lugar, lugar de vida e lugar de clausura, simultaneamente. Portanto assiste-se à formação e a consequente interligação transescalar de diferentes territórios do cárcere em locais fechados, como as unidades de internação para jovens infratores, e em locais de residência, como as favelas e os condomínios exclusivos. Esta constatação tem importância vital para o desenvolvimento da rotina narcotraficante, influenciando diretamente a vida da população carioca. / [en] Think about urban space in Rio de Janeiro first refers to thoughts of violence and fear. Thus the city has been through a strong and intense process of fragmentation of its socialpolitical and spatial dimensions. Compounding this violent scenary emerge the drug dealers factions that dominates most of Rio’s favelas, the state forces – in fact just the police – and ordinary people who watch terrified and afraid, the intense armed conflict, especially the population living in favelas. The sociopolitical and economic power reached by criminal gangs in metropolis of Rio de Janeiro is so influent that legitimates itself at young offenders internment units and adult prisons. Thus these places of confinement connected with the favelas configured territories of intense political and war dispute and play a crucial role in the conduct of the daily dynamics of the city. This correlation is perceived and analyzed through a trans-scalar study which allows us to see the space not only in their territorial feature - as a contention, a prison - but also as a place of life and place of confinement simultaneously. Therefore we are witnessing the formation and its subsequent transescalar interconnection of different prison territories such as young offenders internment unities and places of residence like the favelas and exclusive condominiums. This finding is vital for the drug dealers faction routine development , directly influencing the lives of people in Rio.

Magister Artium - MA / The aim of this thesis is to explore the socio-economic factors that impact on the sustainable harvesting of buchu in the Western Cape of South Africa. Some of the factors that will be explored include poverty, natural resource tenure, legislation, and local practices with regard to the harvesting of buchu. In order to achieve the objectives of the study, which include documenting different local livelihoods, establishing the roles played by the harvesting of wild buchu within these livelihoods, and analyzing perceptions of different stakeholders regarding sustainable harvesting of buchu, the study employed two approaches. The first was a review of the literature, and the second, empirical research in the form of a case study (the communal land owners of Elandskloof, Western Cape) was utilized. Agathosma betulina, one type of buchu and cited as the best type of buchu, has gained popularity as there is a demand for plant material both locally and internationally. This demand has created some concerns for wild populations of buchu as much of the industry is still supplied by populations harvested from the wild. Cultivation of buchu has emerged as a possible pressure lifter to the wild populations, as a poverty reduction strategy (as rural people are also cultivating), and as a way to provide for some of the demand experienced in the market. The buchu industry is a very lucrative one and, therefore, many problems are being identified and experienced. Noting this, the study makes two broad arguments. Firstly, even though the buchu trade is dynamic and fraught with many difficulties, it is a trade that can benefit all stakeholders and, consequently, there is a need for new legislation or a review of the current legislation guiding the industry. Better monitoring and evaluating processes, as well as information and communication platforms where stakeholders can interact, prove important. Hence, this should include the participation from stakeholders at all levels. Secondly, in order to establish effective policy guidelines, an understanding of the social dynamics that influences buchu harvesting is important for the resource sustainability as well as the trade. / South Africa

Os ensaios clínicos ocorrem cada vez mais em uma escala global e as pesquisas patrocinadas vem mudando para as regiões emergentes. A condução desses estudos traz benefícios para centros de pesquisa, pacientes e para o país como um todo. No entanto, a alocação de ensaios clínicos por companhias farmacêuticas multinacionais é um processo complexo determinado por múltiplos fatores e o conhecimento de quais fatores as companhias farmacêuticas valorizam mais ao alocar ensaios clínicos é escasso. Assim, compreender melhor esse processo é essencial para governos e centros de pesquisa que desejam atrair mais ensaios clínicos patrocinados por companhias farmacêuticas multinacionais. O objetivo deste trabalho é apresentar os atributos de centros de pesquisa clínica necessários para melhorar a captação de estudos clínicos patrocinados. Para identificar os fatores considerados determinantes da seleção de centros de pesquisa por patrocinadores e organizações representativas de pesquisa clínica foi desenvolvido um estudo descritivo-exploratório por meio da revisão da literatura através de buscas em bases de dados. As buscas resultaram na seleção de 16 materiais bibliográficos que abordaram a questão seleção de centros de pesquisa. Os fatores considerados mais críticos para a seleção foram disponibilidade de população alvo e capacidade de recrutamento, tempo de start-up e interesse e motivação da equipe do centro. Além disso, a infraestrutura é considerada um pré-requisito que pode inviabilizar a seleção e a qualidade de dados também é muito valorizada. Os custos diretos de execução do ensaio não foram considerados muito importantes, ao contrário dos custos indiretos. A partir do conhecimento dos pré-requisitos e dos fatores determinantes da seleção de um centro para um ensaio clínico multicêntrico patrocinado por companhias farmacêuticas, a Empresa Brasileira de Serviços Hospitalares poderá promover e direcionar os esforços para organizar uma rede de centros de pesquisa que pode ser muito atrativa. / Clinical trials are increasingly occurring on a global scale and sponsored research has been shifting to emerging regions. Conducting these studies brings benefits to research centers, patients, and the country as a whole. However, the allocation of clinical trials by multinational pharmaceutical companies is a complex process determined by multiple factors and the knowledge of what factors pharmaceutical companies value most when allocating clinical trials is scarce. So, better understanding this process is essential for governments and research centers wishing to attract more clinical trials sponsored by multinational pharmaceutical companies. The objective of this work is to present the attributes of clinical research centers necessary to improve the capture of sponsored clinical studies. To identify the factors considered as determinants of the selection of research centers by sponsors and clinical research organizations, a descriptive-exploratory study was developed through the review of the literature through searches in databases. The search resulted in the selection of 16 bibliographic materials that addressed the issue of selection of research centers. The factors considered most critical for center selection were target population availability and recruiting capacity, start-up time, and interest and motivation of the center staff. In addition, infrastructure is considered a prerequisite that can make selection unfeasible and data quality is also highly valued. The direct costs of running the trial were not considered very important, as opposed to indirect costs. From the knowledge of the prerequisites and determinants of the selection of a center for a multi-center clinical trial sponsored by pharmaceutical companies, the Empresa Brasileira de Serviços Hospitalares can promote and direct efforts to organize a network of research centers that can be very attractive.

Text in English / The introduction of the New Growth Path (NGP) and the New Industrial Policy Framework (NIPF) have created an opportunity for the industrialisation of indigenous medicinal and aromatic plants (MAPs Amarula (Sclerocarya birrea), Buchu (Agathosma betulina), and Pelargonium (Pelargonium sidoides) for job creation and economic development in South Africa. The aim is to create a locally sustainable industry which creates jobs as well as improvement of the balance of payments. The National Growth Plan highlights some of the opportunities for industrialization as well as creation of decent jobs. There is increasing pressure on the harvesting of wild indigenous medicinal and aromatic plants (MAPS). The establishment of a local pharmaceutical and nutraceutical industry for processing MAPS remains a challenge in South Africa and many low income countries. The objective of this study was to assess the challenges and their impact looking at particular species, Amarula, Buchu and Pelargonium by using structured focus group interviews with users in communities and businesses in KwaZulu Natal Province, Eastern Cape and the Western Cape. More data/information was also collected from key stakeholder companies including desk-top reviews. Data/information was analysed using the SPSS computer programme and the Atlas software to summarize data and the results. Graphs and tables were used where necessary. The qualitative research reported on some qualitative assessments and challenges facing the establishment of medicinal and aromatic plants in South Africa. Comparative findings from BRICS were also reported. The results of the study indicated that there is continuous exploitation of several medicinal plant species, for plant trade, from the wild and substantial loss of their habitat. The research identifies a number of challenges such as: poor standards for raw materials, lack of research and development linking industry driven revenues, demand exceeding supply, regulatory risk, community risk, lack of understanding of judicious agronomic practices, ethical challenges, liquidity risk as well as political instability fail to attract foreign direct investments. The research concludes that for the establishment of a viable local pharmaceutical industry, iii beverage industry and nutraceutical industry with sustainable harvesting, there are serious hegemonic challenges which will require multi-stakeholder analysis. However, for the South African (SA) industry to be competitive, detailed feasibility studies need to be done comparing SA with other BRICS countries. There is also a need for the Research and Development to be strengthened. It must also be linked into industrial development in the industry. Furthermore there is a need to initiate the incentivizing of the pharmaceutical manufacturing to lower the cost of setting up the businesses in the industry and lessen the need to harvest from South African forests. Furthermore there is a need for programmes of production so that key species are given opportunity for cultivation and the attention they deserve to preserve these depleting resources. / Agriculture and  Animal Health / M.Sc. (Agriculture)

Text in English / The introduction of the New Growth Path (NGP) and the New Industrial Policy Framework (NIPF) have created an opportunity for the industrialisation of indigenous medicinal and aromatic plants (MAPs Amarula (Sclerocarya birrea), Buchu (Agathosma betulina), and Pelargonium (Pelargonium sidoides) for job creation and economic development in South Africa. The aim is to create a locally sustainable industry which creates jobs as well as improvement of the balance of payments. The National Growth Plan highlights some of the opportunities for industrialization as well as creation of decent jobs. There is increasing pressure on the harvesting of wild indigenous medicinal and aromatic plants (MAPS). The establishment of a local pharmaceutical and nutraceutical industry for processing MAPS remains a challenge in South Africa and many low income countries. The objective of this study was to assess the challenges and their impact looking at particular species, Amarula, Buchu and Pelargonium by using structured focus group interviews with users in communities and businesses in KwaZulu Natal Province, Eastern Cape and the Western Cape. More data/information was also collected from key stakeholder companies including desk-top reviews. Data/information was analysed using the SPSS computer programme and the Atlas software to summarize data and the results. Graphs and tables were used where necessary. The qualitative research reported on some qualitative assessments and challenges facing the establishment of medicinal and aromatic plants in South Africa. Comparative findings from BRICS were also reported. The results of the study indicated that there is continuous exploitation of several medicinal plant species, for plant trade, from the wild and substantial loss of their habitat. The research identifies a number of challenges such as: poor standards for raw materials, lack of research and development linking industry driven revenues, demand exceeding supply, regulatory risk, community risk, lack of understanding of judicious agronomic practices, ethical challenges, liquidity risk as well as political instability fail to attract foreign direct investments. The research concludes that for the establishment of a viable local pharmaceutical industry, iii beverage industry and nutraceutical industry with sustainable harvesting, there are serious hegemonic challenges which will require multi-stakeholder analysis. However, for the South African (SA) industry to be competitive, detailed feasibility studies need to be done comparing SA with other BRICS countries. There is also a need for the Research and Development to be strengthened. It must also be linked into industrial development in the industry. Furthermore there is a need to initiate the incentivizing of the pharmaceutical manufacturing to lower the cost of setting up the businesses in the industry and lessen the need to harvest from South African forests. Furthermore there is a need for programmes of production so that key species are given opportunity for cultivation and the attention they deserve to preserve these depleting resources. / Agriculture and  Animal Health / M. Sc. (Agriculture)

The aim of this thesis was to explore the socio-economic factors that impact on the sustainable harvesting of buchu in the Western Cape of South Africa. Some of the factors that were explored include poverty, natural resource tenure, legislation, and local practices with regard to the harvesting of buchu.

The aim of this thesis was to explore the socio-economic factors that impact on the sustainable harvesting of buchu in the Western Cape of South Africa. Some of the factors that were explored include poverty, natural resource tenure, legislation, and local practices with regard to the harvesting of buchu.