There are many differentiated product industries in which firms offer multiple products in the same market. In making strategic decisions regarding entry, quality and quantity to be supplied for their multiple products firms must consider the competition with rivals as well as cannibalization of their own products that are close substitutes. In this setting, understanding the relationship between the behavior of consumer demand and firms decisions' regarding product characteristics and strategic variables like advertising are fundamental issues in industrial organization. This dissertation empirically explores these fundamental issues in the pharmaceutical and airline industries. The first paper of my dissertation estimates consumer demand for different anti-cholesterol drugs using panel data on a nationally representative sample of individuals who were diagnosed with cholesterol problems in the period 1996-2002. The data provides detailed information on individuals' medical conditions, medical and drug insurance coverage, drug purchases (if any), and other demographic and medical information. Individuals choose whether to purchase an anti-cholesterol rug and, if so, which drug to buy. The model permits flexible substitution patterns among drug choices and persistence in those choices by incorporating both observed and unobserved consumer heterogeneity. The estimates suggest that lower income patients without prescription drug insurance are very price sensitive: they are less likely to use drugs and, if they do use them, they tend to purchase the less expensive drugs. I find that roughly 500 thousand individuals without drug insurance who are currently not purchasing anti-cholesterol drugs would do so in the counterfactual world in which they are given the standard co-payment plan. The second paper also looks at consumer demands for anti-cholesterol drugs. While the first paper focused on the differentiated products, this paper explores the market expansion effects of direct-to-consumer advertising (DTCA). The study combines the individual data used in the first paper with monthly expenditure data on DTCA for the period 1996-2002. The dynamic demand model estimated in this paper explores the heterogeneous effects of DTCA. Overall, I find a positive effect from DTCA with short term elasticity of 0.107. Through persistence in consumer demand this effect lasts over multiple time periods. I find that individuals not taking a cholesterol drug respond more to advertising than those on the drug. In addition, I find that less educated individuals, those that may be unaware of their health condition, and those without health insurance are most responsive to DTCA. Finally, the third paper studies the effect of product ownership and quality on entry in the airline industry. Specifically, this paper empirically examines the decision of an airline to offer high quality nonstop service between cities given that the airline may or may not be offering lower quality one-stop service. I find that airlines that offer one-stop service through a hub are less likely to enter that same market with nonstop service than those that do not. In addition, the quality of the one-stop service is another determinant of entry. Airlines are more likely to enter a market with nonstop service if their own or their rival's one-stop service in the market are of lower quality. / text

Thesis (MTech. degree in Pharmaceutical Sciences)--Tshwane University of Technology, 2009. / Quality control procedures are vital in the pharmaceutical industry to guarantee the authenticity and quality of products. A major challenge in quality assurance of herbal material is the vast variation of active constituents in plants from the same species. As a result of this variation, the selection of only a few compounds as criteria for quality control is inadequate. Pelargonium (P.) sidoides is indigenous to South Africa and highly valued by traditional healers as a remedy to treat coughs, upper respiratory tract irritations and gastrointestinal conditions. An ethanolic extract of P. sidoides is used in the proprietary herbal tincture known as Umckaloabo®. The composition and concentration of polyphenols are parameters which determine the quality of this herbal medicine because it provides several therapeutic benefits in the non-specific medicinal treatment of infectious diseases. Despite the commercial development of P. sidoides very few studies have been conducted to document the full phytochemical range of variation for natural populations and no study has been published on the development of a fast accurate quality control method for the validation of raw material.

Aktuell gibt es unterschiedliche Trends in der pharmazeutischen Industrie. Die Herstellung von API´s wird zunehmend bei den Herstellern der finalen Produkte vorgenommen. BIG Pharma integriert die API Herstellung in House. Die Batchproduktion geht tendenziell zu immer kleinen Volumen mit speziellen Anwendungsbereichen. Produkte mit größerem Volumen werden vom Batchvolumen in eine kontinuierliche Produktion überführt und speziell auch auf diese neue Herstellungstechnologie entwickelt. Die Anforderungen für diese unterschiedlichen Applikationen sind völlig unterschiedlich.

Research Doctorate - Doctor of Philosophy (PhD) / In January 2005 Australia implemented the Australia-United States Free Trade Agreement (AUSFTA). The AUSFTA was a historic document because it laid out a closer trading association between Australia and its close ally, the United States (US). The Agreement was generally welcomed in both countries but it contained provisions that were controversial, perhaps none more so than those covering pharmaceuticals. In Australia there was deep concern over the effects of these provisions on the Pharmaceutical Benefits Scheme (PBS). A Senate Committee investigating the likely impact of the AUSFTA was apprehensive that the provisions would result in the PBS paying higher prices for some medicines. The many outcomes from the research reported in this thesis are preliminary but amongst them, three stood out. First, the AUSFTA instituted a number of small but significant changes to Australian pharmaceutical policies and processes. Some changes, around transparency and listing times, were positive while others, such as sponsor hearings before the PBAC, will probably have limited negative impact. Second, there is now a need to consider the AUSFTA commitments when Australian health policy is reassessed in the future, which will now make Australia’s regulatory processes more complex. Third, it is argued that the AUSFTA may have had input into major reforms of the Australian PBS. These reforms delivered on an outcome that had been sought by the US: a weakening of reference pricing as used by the Australian PBS. The benefit from the change to reference pricing for Australia is unclear, but the PBS is now more vulnerable to higher prices for new medicines in the future.

Thesis (Ph. D.)--University of Chicago, Graduate School of Business, August 2002. / Includes bibliographical references. Also available on the Internet.

Material supply systems have for a long time been regarded as an important function with strong potential to increase the performance of companies in different industries. Consequently, substantial research has been conducted in the field. However, in the pharmaceutical industry within research and development plants, material supply systems have historically not been a prioritized function. Therefore, there is a research gap regarding material supply systems in that peculiar context. This study aims to fill that gap by investigating how a material supply system could be designed and which factors are critical to achieve a cost-efficient service level within a research and development plant in the pharmaceutical industry. To do so, a single case study has been conducted at a Swedish pharmaceutical company’s research and development plant. An abductive approach has been applied to both test if the general design principles developed in other industries and business functions can be applied to this context. Further, context specific factors affecting the material supply system design needed to be identified and investigated to adapt the general design principles to the specific context by generalizing data. The empirical data was collected by utilizing focus groups, interviews, observations and documents. The findings yielded that there is a substantial potential for improvement of material supply systems within the context of this study. The existing decentralized inventory structure at the case company was a particularly vital aspect that hindered the system from operating cost-efficiently in relation to the service level and a centralization is crucial to improve. Further, calibration and a general decrease of safety stocks, order points and order quantities is essential to uphold a consistent service level at a justifiable cost at the case company. The general design principles and formulas retrieved from the theoretical framework was partly applicable in the context of this study but needed some adjustments. Especially the low volume articles with high variety in consumption rate was not suitable to be managed by the existing methods and needed another approach. Further, the context establishes high requirements on system dynamics, it comes with boundaries due to laws regulating the industry, and companies in the context generally need to be better at aligning their design factors to the purpose. The result of this study adds valuable content to the research field and fills the gap for material supply systems in the context of research and development plants in the pharmaceutical industry. Further studies are needed in this field to investigate how articles with low and varying demands can be managed within material supply systems cost-efficiently and with high service levels.

A talidomida foi amplamente prescrita entre 1950 e 1960, em quase 50 países, como hipnosedativo não-barbitúrico e antiemético para indisposição matinal durante a gravidez, sendo em seguida fortemente controlada em função da ocorrência de sérios problemas de teratogenicidade. Nos últimos anos, vários esforços foram realizados no sentido de buscar identificar e elucidar as propriedades antiinflamatórias, imunomodulatórias e antiangiogênicas da talidomida. Na mesma direção, investigações clínicas foram conduzidas em pacientes com diversas doenças, como mieloma múltiplo, carcinoma renal, câncer de próstata, Síndrome da rejeição paciente-enxerto, entre outras. A talidomida possui um centro quiral e dois anéis amida em sua estrutura e é sintetizada como racemato, constituída por dois enantiômeros ativos: (+)-(R)- e (+)-(S)-talidomida. A talidomida racêmica apresenta duas formas polimórficas, alfa ( ) e beta ( ). Assim, a variabilidade observada em relação ao polimorfismo representa um ponto crítico se considerarmos o potencial de alteração de propriedades biofarmacêuticas em decorrência da predominância de um ou outro polimorfo. No Brasil o medicamento talidomida é fabricado exclusivamente pela FUNED – Fundação Ezequiel Dias, laboratório público do Estado de Minas Gerais que integra o Sistema Oficial de produção de Medicamentos do País. Neste contexto, este trabalho tem como principal objetivo a avaliação de características físicas, físico-químicas e tecnológicas dos polimorfos da talidomida, com ênfase nos ensaios de cristalização, dissolução, degradação e compressão. Os resultados deste trabalho contribuíram para um melhor entendimento da relação entre características cristalográficas e propriedades farmacêuticas, agregando uma base científica capaz de avaliar as diferenças existentes destes polimorfos e garantir o controle de qualidade adequado do produto final produzido em um Laboratório Oficial. Estes estudos contribuíram para o cumprimento de exigências regulatórias. / Thalidomide was widely prescribed between 1950 and 1960, in nearly 50 countries, as sedative and antiemetic for morning sickness during pregnancy. After the occurrence of serious problems of teratogenicity it was heavily controlled. Growing interest has been observed in recent years to identify and elucidate the anti-inflammatory, immunomodulatory and anti-angiogenic properties of thalidomide. In the same direction, clinical investigations have been conducted in patients with various diseases such as myeloma, renal carcinoma, and prostate cancer, among others. Thalidomide possesses a chiral center and two amide rings in its structure and is synthesized as racemate, consisting of two active enantiomers: (+)-(R)- and (+)-(S)-thalidomide. It is known that the racemic thalidomide has two polymorphic forms, alpha ( ) and beta ( ). Thus, the observed variability in relation to the polymorphism represents a critical point considering the potential of changes in biopharmaceutical properties due to the predominance of one of them. In Brazil thalidomide tablets are manufactured exclusively by FUNED – Fundação Ezequiel Dias, the public laboratory of the State of Minas Gerais, which integrates the Country's Official System of drug production. In this context, the objectives of this work are the assessment of physical characteristics, physicalchemical and technological properties of polymorphic forms of thalidomide, with emphasis on crystallization, dissolution, degradation and compression. The results of this work contributed to a better understanding of the relationship between characteristic crystallographic properties and pharmaceutical properties, aggregating a scientific basis to assess the differences of these polymorphs and ensure the appropriate quality control of the final product produced in an official laboratory. These studies contributed to compliance with regulatory requirements.

Submitted by Eduardo Gomensoro (eduardo.gomensoro@hotmail.com) on 2016-01-13T18:04:57Z No. of bitstreams: 1 Dissertação MEX 2014_Eduardo Eugênio Bittenourt de Gomensoro.pdf: 3249581 bytes, checksum: 6b2303bb623756497a892a0212462b9f (MD5) / Approved for entry into archive by Janete de Oliveira Feitosa (janete.feitosa@fgv.br) on 2016-01-14T19:17:31Z (GMT) No. of bitstreams: 1 Dissertação MEX 2014_Eduardo Eugênio Bittenourt de Gomensoro.pdf: 3249581 bytes, checksum: 6b2303bb623756497a892a0212462b9f (MD5) / Approved for entry into archive by Marcia Bacha (marcia.bacha@fgv.br) on 2016-01-21T13:35:05Z (GMT) No. of bitstreams: 1 Dissertação MEX 2014_Eduardo Eugênio Bittenourt de Gomensoro.pdf: 3249581 bytes, checksum: 6b2303bb623756497a892a0212462b9f (MD5) / Made available in DSpace on 2016-01-21T13:35:20Z (GMT). No. of bitstreams: 1 Dissertação MEX 2014_Eduardo Eugênio Bittenourt de Gomensoro.pdf: 3249581 bytes, checksum: 6b2303bb623756497a892a0212462b9f (MD5) Previous issue date: 2015-12-14 / In the pharmaceutical industry relationships based on trust are fundamental for work team function in all levels. There is a strong impact of change, and derived uncertainty, in the trust dynamics between the work teams and their motivation. In recent academic production, the liaisons between trust and performance have been explored and, particularly, we bring forth the results of the first empirical research conducted in Brazil to measure the interpersonal trust levels, trust indicators and employee commitment inside a representative sample of private sector Brazilian organizations. The organizations researched and compared by Prof. Marco Túlio Zanini were selected as being representative of the 'new' and 'old' economies, among which the main differentiators are the knowledge management and the high level of uncertainty secondary to the frequent organizational and environmental change. These aspects associate companies of the research-based pharmaceutical industry to companies of the 'new' economy, in accordance to Prof. Zanini’s study. Companies of the pharmaceutical industry are going to implement important changes in their ways of doing business in the coming years, most of all in which concerns their communication, promotion and management of commercial work teams, and this seems to be a particularly interesting time for a study like the described in this dissertation. The aim of this work was to determine the level of similarity between the trust indicators among a commercial workforce from the biotechnological product segment (vaccines) of a major global organization of the research-based pharmaceutical industry, and the indicators obtained from organizations of the 'new' economy. We intended to measure the interpersonal trust and commitment indicators among the commercial workforce of the organization, in order to access the effects of enterprise uncertainty upon them. Our research tools were a previously validated survey, conducted upon the whole promotional team (56 members) of a specific area of the studied organization; public and private company data (the company remains undisclosed and identified as Company 'J'), and complementary in-depth interviews with key managers of the subject team: national and regional managers. Some similarity was found between the trust and commitment indicators of the companies of the 'old' economy and the indicators from Company 'J', for most of the evaluations. Nevertheless, some resemblance was also found between the indicators from companies of the 'new' economy and Company 'J', most of all among the managers of the latter. This could be an indicator of the impact of some measures recently implemented by Company 'J', which could have increased organizational uncertainty and instability. From the acquisition, analysis and comparison of this indicators we propose some discussion on the impact of the recent changes implemented on the relational work contract within Company 'J' and the relative relational dynamics inside its commercial workforce. / Na indústria farmacêutica (IF) são fundamentais as relações de confiança nas equipes de trabalho em todos os níveis. Há um forte impacto das mudanças, e da consequente incerteza, na confiança entre as equipes e sua motivação. Na produção acadêmica recente, as relações entre confiança e desempenho são exploradas e, particularmente, temos os resultados da primeira pesquisa feita no Brasil para mensurar os níveis de confiança interpessoal, indicadores de confiança e comprometimento dos colaboradores dentro de grandes empresas privadas. As empresas estudadas, e comparadas pelo Prof. Zanini, foram representantes da 'nova' e 'velha' economia, entre as quais os grandes diferenciadores são a gestão do conhecimento e o nível de incerteza decorrente das frequentes mudanças. Estes são pontos que aproximam as empresas da indústria farmacêutica de pesquisa às da 'nova' economia segundo a abordagem proposta na pesquisa do Prof. Zanini. As empresas da indústria farmacêutica estarão implementando mudanças importantes em sua forma de conduzir o negócio, principalmente no que toca à comunicação, promoção e gestão das equipes comerciais nos próximos anos e este parece ser um momento particularmente interessante para uma pesquisa como esta. O objetivo deste trabalho foi determinar o nível de similaridade das equipes de propaganda (comerciais) do segmento de produtos biológicos (vacinas) de uma grande empresa multinacional da indústria farmacêutica de pesquisa, com os as equipes de empresas da nova economia. Pretendemos mensurar os níveis de confiança interpessoal, indicadores de confiança e comprometimento dos componentes das equipes comerciais da empresa, com vistas a examinar os efeitos das incertezas institucionais sobre os mesmos. As ferramentas de pesquisa foram: um formulário previamente validado aplicado aos 56 membros da força de vendas de uma área específica da empresa; dados públicos e privados da empresa (que permanecerá identificada como Empresa 'J') e entrevistas em profundidade com os gestores-chave da equipe sob avaliação: gerentes nacionais e distritais da força de vendas. Foi encontrada alguma similaridade entre os índices das empresas da 'velha' economia e os da empresa 'J', para a maioria das avaliações. Entretanto, alguma semelhança entre os índices da Empresa 'J' e os das empresas da 'nova' economia também foi evidenciada, sobretudo na avaliação dos gerentes desta. Isto poderia indicar o impacto de algumas medidas implementadas pela Empresa 'J' mais recentemente, que podem ter colaborado na geração de um ambiente de incerteza institucional e instabilidade. A partir da obtenção e comparação destes índices, são propostas considerações sobre as mudanças ocorridas nos contratos relacionais de trabalho dentro da Empresa 'J' nos últimos anos e sobre as dinâmicas aparentes nas relações de sua equipe comercial.

Made available in DSpace on 2015-08-19T13:52:52Z (GMT). No. of bitstreams: 2 2.pdf: 6249517 bytes, checksum: 33d31da982124bd94dd704386c611afa (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. / Atualmente, a indústria farmacêutica encontra-se inserida em um cenário de acirrada competição, enfrenta custos crescentes de pesquisa e desenvolvimento e está submetida a maiores exigências regulatórias. Soma-se a este quadro, reduzida eficiência operacional. Neste contexto, torna-se importante que as empresas farmacêuticas busquem mensurar e melhorar o desempenho de suas operações e equipamentos. Mundialmente e em diversos segmentos industriais, o indicador de eficácia global de equipamentos (Overall Equipment Effectiveness, OEE) é adotado como métrica do desempenho de máquinas e linhas produtivas. Através de estudo de caso, aplicado à produção de Farmanguinhos, verificou-se que o emprego da OEE permite identificar e quantificar as perdas que afetam o funcionamento dos recursos produtivos, servindo de base para o desenvolvimento de ações de melhoria contínua. Na implantação do indicador é fundamental assegurar que os operadores responsáveis pela coleta dos dados assimilem os objetivos e conceitos da metodologia e sejam capacitados a classificar corretamente as perdas. A análise dos resultados de OEE evidenciou que os processos de troca de máquina (set ups) representaram os desperdícios de maior impacto sobre a disponibilidade dos equipamentos em estudo. Foi verificado que princípios da troca rápida de ferramentas (Single Minute Exchange of Dies , SMED) podem ser utilizados para redução do tempo destas operações. / Currently, the pharmaceutical industry is inserted in a scenario of fierce competition, facing rising costs of research and development and is subjected to increased regulatory requirements. Reduced operational efficiency is added to this picture. In this context, it is important that pharmaceutical companies strive to measure and improve the performance of its operations and equipments. Worldwide and in several industrial sectors, Overall Equipment Effectiveness (OEE) indicator is adopted as the performance metric of machines and production lines. Through case study, applied to Farmanguinhos production, it was verified that the use of OEE enables identifying and quantifying the losses that affect productive resources operation, providing the basis for the development of continuous improvement actions. In the indicator’s implantation it is fundamental to assure that operators responsible for data collection assimilate the purposes and concepts of the methodology and are able to classify the losses correctly. The analysis of OEE results revealed that set up processes represented the waste of largest impact on the availability of the equipments under study. It was verified that principles of Single Minute Exchange of Dies (SMED) can be used to reduce the time of these operations.

Made available in DSpace on 2015-08-19T13:52:54Z (GMT). No. of bitstreams: 2 7.pdf: 1259773 bytes, checksum: c014c0a8beba83eb25b192dcfc910ae7 (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 papel e atuação de Farmanguinhos/FIOCRUZ, em parceria com o Ministério da Saúde, na produção de medicamentos com qualidade e eficácia para a população possuem reconhecimento nacional e internacional. Existe uma dependência em relação a um conjunto de fatores que integram poder econômico, questões sociais e bases legais, necessitando assim,como um de seus alicerces, de uma gestão estratégica competente, moderna, transparente e focada em resultados.Utilizando-se como referência a metodologia de gestão estratégica organizacional conhecida como Balanced Scorecard (BSC) e as exigências dos órgãos reguladores direcionadas às indústrias farmacêuticas, foi proposto um modelo de BSC para Farmanguinhos, representado na forma de Mapa Estratégico. Este modelo foi baseado nas diretrizes e fundamentos tradicionais da metodologia mencionada, com foco na administração pública. Foram realizadas, a partir de um questionário semi-estruturado, entrevistas junto a cinquenta e dois gestores de Farmanguinhos, com o propósito de levantar informações que fundamentassem a elaboração de um Mapa Estratégico. A partir das entrevistas foi realizado o tratamento das informações coletadas, sua classificação e organização das mesmas por temas importantes para a administração da Unidade. Os dados obtidos com o projeto permitiram a proposição de um Mapa Estratégico customizado para Farmanguinhos. O Mapa, apresentado neste estudo, é um instrumento a ser avaliado pela alta gestão da Instituição e necessita passar por um processo de validação antes de sua efetiva aplicação na rotina desta Instituição. A contribuição deste trabalho para a Unidade é o contínuo aprimoramento na condução das estratégias de Farmanguinhos. Pretende-se, com a elaboração desta proposta, contribuir com a gestão estratégica de Farmanguinhos, como unidade vinculada ao Ministério da Saúde, visando a obtenção de resultados necessários à uma indústria farmacêutica pública. Espera-se também que esta modelagem seja promotora de maior confiança e efetividade das suas ações, assim como, maior visibilidade, transparência, integração e controle social de suas atividades, com consequente melhora no atendimento frente às demandas do Ministério da Saúde. / The role and performance of the Farmanguinhos/FIOCRUZ, in partnership with the Health Ministry, in the production of quality and effectiveness medicines for population, possesses national and international acknowledgement. There is a reliance on a set of factors that include economic power, social and ethical issues and also legal bases, thus necessitating, as one of its foundations, a competent strategic management, modern, transparent and focused on results. Using as reference the organizational strategic management methodology known as Balanced Scorecard (BSC) and the requirements of regulators directed to pharmaceutical industries, it has proposed a BSC model for Farmanguinhos, represented as a Strategy Map. This model was based on the guidelines and rationale of the traditional method mentioned, with a focus on public administration. They were made, from a semi-structured questionnaire, interviews with fifty-two Farmanguinhos’s managers, for the purpose of gathering information to substantiate the development of a Strategy Map. From the interviews,it was carried out the processing of collected information, their classification and their organization by important issues to the unit administration. The datas obtained from the project allowed to propose a customized strategic map for Farmanguinhos. The map, presented in this study, isan instrument that will be evaluated by senior management of the institution and has to go through a validation process before its effective implementation in the institution routine. The contribution of this work is to drive the continuous improvement in the conduct of Farman guinhos’ strategies. The aim of this proposal is to contribute to the st rategic management of Farmanguinhos, as a unit under the Health Ministry,in order to obtain the required results to a pharmaceutical public industry. It is also hoped that this model will promote greater of confidence and effectiveness related to their actions, as well as greater visibility, transparency, integration and social control of its activities, with consequent improvement in the service meet according to demands of the Health Ministry.