Thesis (MBA)--Stellenbosch University, 2012. / Analgesics are the medication most-generally used by modern society. The pain management market has therefore experienced substantial growth over the last few years. This research report aims to provide a critical review of pain management in the pharmaceutical market in South Africa, in order to establish and evaluate the most significant growth factors. This research report provides an overview of the history of pain, the basic physiology of pain and pain classification systems. There are three categories of analgesics - opioid analgesics, non-opioid analgesics and adjuvant analgesics. These categories of analgesics have been analysed according to the most generally-used MIMS pharmacological classification system referring to the analgesic therapeutic classes. These are narcotic analgesics, analgesics and antipyretics, combination analgesics, others such as tramadol and musculo-skeletal agents which consist of NSAIDs and COX inhibitors. Growth over the last four years (from August 2009 to July 2012) will be determined by analysing data per molecule, per product and per manufacturer. Splits between branded and generic drugs will also be analysed. Top prescribers by healthcare professionals will be examined, analysing scripting data from ImpactRx, which covers 85% of the private market data nationally. There are currently approximately 41 analgesic molecules in the assessed pain market which has produced 738 analgesic products. The analgesic market (worldwide and in South Africa) has seen the launch of only a few new drugs. New molecules of the same drug class or family have been launched, but in effect they can be viewed as mere line extensions with claimed reduction in side effects, advanced delivery times or improved efficacy. Two new molecules have been launched in the South African market in the narcotic analgesic class, (oxycodone and hydromorphone), however these molecules have been available internationally for years. Accelerated growth of the pain management market has mainly been met by combination analgesics, which in essence are not new, but rather a combination of different active ingredients or new drug delivery systems. The impact of product withdrawals on market share is also evaluated. The development and acceptance of generics are highlighted as key contributing factors in the growth of the analgesic market. Important to note is that generics often compete in their own generic market share. This may be the reason why the generic market does not show a significant increase over branded products. Another significant trend evident in the increased acceptance of generics, is that manufacturers, in order to keep market share, may choose to produce their own generic medication after their branded products patent has expired. Pain is one of the main reasons why patients seek medical attention and it is the physician’s ethical responsibility to treat patients and provide them with effective pain relief medication. The WHO analgesic ladder as a guideline for treating pain has proven to be effective after 25 years in practice. It is forecasted that an increase in the narcotic analgesic class will be noted. Pain is heavily undertreated worldwide and in South Africa, Increased awareness, education, new advanced research and knowledge may help to address this dilemma.

published_or_final_version / Business Administration / Master / Master of Business Administration

published_or_final_version / Urban Planning / Master / Master of Science in Urban Planning

Thesis titled Commercial communications in czech pharmaceutical industry is about how to use marketing communication tools (advertising, public relations, sales promotion, personal selling, etc.) in the pharmaceutical industry. A specific feature of pharmaceutical marketing is separate communication to public (patients) and to professionals (doctors) which requires using different communication messages and also different channels to each target group. Pharmaceutical marketing is regulated by advertising law, by the Council for Radio and TV Broadcasting and by the provisions of the State Institute for Drug Control which control the ways how two target groups are addressed. Possible marketing tools are described from both theoretical (legal) and also practical (marketing communication of specific pharmaceutical company) terms.

This thesis is dedicated to the potential of pharmaceutical industry targeting an increase in EU world competitiveness. Pharmaceutical industry plays an important role in world economy, both from the social and economic point of view. In particular, this thesis is focused on macroeconomic contribution of pharmaceutical industry into world economy emphasizing the situation of EU. Particularly, the thesis consists of evaluating the situation, importance and barriers of development of pharmaceutical industry in EU and it, also, points out the main directions towards positive development of this sector, including the international and national cooperation. Pharmaceutical industry is the key sector in the EU competitiveness increase.

A FDA tem incentivado a indústria farmacêutica a implantar no seu sistema de controle de qualidade métodos rápidos para avaliação do produto durante seu processo de produção e/ou na sua forma final para comercialização. Na indústria farmacêutica, o doseamento microbiológico é amplamente utilizado pelo setor de Controle de Qualidade com objetivo de avaliar a eficácia e segurança do medicamento produzido, principalmente no que diz respeito a produção de antibióticos. No caso desses, a aplicabilidade de métodos rápidos é de suma importância a fim de se obter uma avaliação rápida e confiável do produto, garantindo assim a comercialização de medicamentos com a qualidade e segurança necessárias para o sucesso do tratamento terapêutico. O objetivo deste trabalho foi desenvolver e validar método para doseamento microbiológico de nistatina, com leitura cinética em microplaca, perfeitamente intercambiável com o método tradicional de difusão em ágar, porém com redução do tempo de execução e de liberação do resultado final. Os parâmetros definidos para este ensaio foram: utilização de inóculo com 5% de Candida albicans (ATCC 10231), meio de cultura líquido, tempos de 48 horas para crescimento do micro-organismo e 8 horas para leitura das micro-placas, , temperatura de análise de 30 °C e absorbância de 630 nM. Os parâmetros avaliados no processo de validação, de acordo com os códigos oficiais vigentes, demonstraram que o método é sensível, robusto, linear (r = 0,97332), precisão (repetibilidade: 96 %, DPR= 6 % / precisão intermediária: 97 %; DPR = 7 %) e exato ( 97 %, DPR = 7 %). Em comparação ao método de difusão em ágar tradicional, o método desenvolvido demonstrou a mesma eficiência do método já utilizado, contemplando todos os parâmetros do processo de validação, com a vantagem de ser realizado em menor tempo e com o uso reduzido de material de análise, como meio de cultura, padrão e amostra. Em função disso, pode-se concluir que o método desenvolvido e validado além de representar uma tendência mundial, por ser efetuado de modo rápido, eficaz e econômico, é perfeitamente aplicável a rotina laboratorial. / The FDA have been encouraging the pharmaceutical industry to deploy in their system of quality control a rapid method for assessment of the product during its production process and/or in their final form for sale. In the pharmaceutical industry, the microbiological assay is widely used by the Quality Control sector to evaluate the efficacy and safety of the product produced, especially as regards the production of antibiotics. In such case, the applicability of rapid methods is very important in order to obtain a rapid and reliable evaluation of the product, thus ensuring the marketing of medicinal products with the quality and security necessary for the success of therapeutic treatment. The aim of this study was to develop and validate an method for the microbiological assay of Nystatin with kinetic micro-plate reading, perfectly interchangeable with the traditional method of agar diffusion, but with reduced time for implementation and release of the final result. The parameters set for this assay were using 5 % inoculum of Candida albicans (ATCC 10231), liquid culture medium, time of 48 hours for growth of micro-organisms and 8 hours for reading the micro-plate temperature analysis of 30 °C and absorbance of 630 nM. The parameters evaluated in the validation process, according to the current official codes, shows that the method is sensitive, robust, linear (r = 0,97332), precision (repeatability: 96 %, RDS = 6 % / inter-day precision = 97 %, RSD = 7%) and accurate (97 %, RDS = 7%). Compared to the traditional method of diffusion in agar, the developed method demonstrated the same efficiency of the method already used, covering all parameters of the validation process, with the advantage of being performed in less time and with reduced use of material for analysis, as the culture medium and standard sample. As a result, it can be concluded that the method developed and validated besides representing a global trend, being made fast, effective and economical way, is perfectly applicable to routine clinical practice.

O objetivo deste trabalho foi realizar diagnóstico para solução de problemas de atraso na entrega das atividades e relatórios de pesquisa, bem como de dificuldade de se definir o objetivo e escopo do projeto, encontrados no departamento de estudos pré-clínicos e clínicos de empresa de saúde animal. Isso porque, antes dos novos produtos veterinários entrarem no mercado, estes devem passar por testes que comprovem sua eficácia e segurança, conforme exigido pelo órgão regulatório. Neste contexto, verifica-se a importância da realização de estudos clínicos conforme planejamento e prazos previamente estabelecidos, pois estes impactam diretamente nos resultados e planejamento estratégico da empresa. Para tanto, foi realizado diagnóstico dos atrasos através de avaliação de cronogramas de projetos finalizados. Como proposta de solução foi elaborado um formulário de planejamento de projetos a partir dos conceitos do PMBOK®. Este foi aplicado no início de cada novo projeto e inserido no fluxograma de processos do departamento. Para avaliação dos resultados da inserção deste formulário foram aplicados aos colaboradores do departamento questionários fechados juntamente a cada preenchimento do formulário. Os dados obtidos destes questionários foram avaliados através da análise de componentes principais. Além disso, foi realizada entrevista semiestruturada com os colaboradores para verificar efetivamente a mudança no cenário do departamento pós-formulário, sendo os dados avaliados conforme método de análise de discurso. Como resultados foi verificado que ocorreram atrasos em pelo menos 50% das atividades presentes nos 22 cronogramas de projetos avaliados, isso devido principalmente ao planejamento inadequado, de acordo com os relatos dos colaboradores. Com a aplicação do formulário e análise dos dados dos questionários e das entrevistas foi possível verificar que a utilização do formulário tem grande importância na definição dos objetivos do projeto, definição de escopo, e consequente definição das atividades indicadas para cada estudo, ou seja, auxilia no planejamento do estudo. Além disso, proporciona aos colaboradores a reflexão e visão crítica dos projetos, assim como deixa documentado tudo aquilo que foi pensado evitando retrabalhos posteriores. / The objective of this study was to perform a diagnosis to solve problems of delay in activities and research reports\' delivery, as well as the difficulty to define project\'s objective and scope, found in the pre-clinical and clinical studies department of animal health company. This happens because new veterinary products must undergo tests that prove their efficacy and safety, as required by the regulatory agencies before being marketed. In this context, it is important to carry out clinical studies according to the planning and deadlines previously established, as these have a direct impact on the results and strategic planning of the company. For this purpose, the delays were diagnosed through the evaluation of completed project schedules. As a proposal for solution, a project planning form was developed based on PMBOK® concepts. This was applied at the beginning of each new project and inserted into the department\'s process flowchart. To evaluate insertions\' results of this form a closed questionnaire was applied to employees of the department with each filling out form. The data obtained from these questionnaires were analyzed through principal components analysis. In addition, a semi-structured interview was conducted with the employees to effectively verify the change in the post-form department scenario and the data were evaluated according to the discourse analysis method. As results it was verified that there were delays in at least 50% of the activities present in the 22 schedules of evaluated projects, mainly due to inadequate planning, according to the collaborators reports. With form\'s application and data\'s analysis of questionnaires and interviews it was possible to verify that the use of the form has great importance in the definition of project\'s objectives, definition of scope and consequent activities\' definition indicated for each study. In other words, it assists in the planning of the study. In addition, it provides the employees with the reflection and critical vision of projects, as well as documenting everything that was thought avoiding subsequent rework.

Esta tese de doutorado trata de como processos inovativos podem ser viabilizados e estimulados a partir da externalização de capabilities antes realizadas internamente à empresa. Para atingir o objetivo proposto foi escolhido o setor farmacêutico, cujo processo inovativo é constante e permeia, em diferentes graus, todas as etapas da cadeia, além da organização da sua cadeia ser propícia à desverticalização. A unidade de análise utilizada é a capability, neste caso as atividades relacionadas a pesquisa e desenvolvimento e manufatura. A partir da consulta de uma base de dados estrangeira, foi selecionado um conjunto de artigos técnicos que incluiu o tema e o setor alvo da tese. A sistematização dos dados permitiu identificar o tipo de atividade externalizada, a situação em que isso ocorria, suas principais motivações e resultados, bem como os detalhes das empresas envolvidas. A análise da externalização de atividades de pesquisa mostra quatro formas de aceleração da inovação: (1) aquela alcançada a partir do acesso a tecnologias que não seriam acessíveis de outra maneira, acelerando a fase clínica do desenvolvimento; (2) a que agrega etapas permitindo acelerar a fase clínica do desenvolvimento; (3) a da etapa de formulação que possibilitou acelerar o estágio de desenvolvimento, e (4) a relacionada a estágios da química de descoberta permitindo acelerar a própria fase, além da conseguinte. A análise da externalização de atividades de manufatura mostra um movimento de inclusão de etapas a jusante da cadeia, no caso aquelas de desenvolvimento, constantes nos dados analisados beneficia a manufatura além do produto final, mas também em termos de inovação de processo. A aceleração da inovação ocorre principalmente por possibilitar ter o produto mais rápido para ser lançado ao mercado. Os dados são convergentes com o argumento central de que ao permitir acesso a capabilities fora das fronteiras da firma, o outsourcing é ferramenta que viabiliza a inovação. A conclusão é de que as decisões tomadas não seguem uma norma pré-determinada, uma prescrição. Não há mais o referencial seguro da integração vertical, nem de uma best practice. Cada empresa deve decidir, a partir de parâmetros que ela mesma pode determinar, a melhor forma de resolver os desafios competitivos que lhe são propostos de maneira irrecusável e incontornável. / Innovation has become a central element of the economic system. This thesis focuses on how outsourcing capabilities can foster innovation process. It does so by analyzing the pharmaceutical sector, an innovative industry which value chain can be easily disaggregated in several stages that embrace different industrial actors. The analysis unit is the capability, in this case the capabilities related to research and manufacturing activities. By means of a database searching, a system with a range of technical articles treating the central subject of the thesis was build up. The information has been classified in order to identify outsourced activities, in which situations outsourcing happens, as well as main reasons and outcomes of the outsourcing process. It also allowed knowing better what kind of companies were involved in the strategy. Outsourcing research pharmaceutical capabilities provides four main routes to nurture innovation: (1) by accessing new technologies, (2) by aggregating research phases, (3) by means of outsourced formulation activity and (4) outsourced drug discovery chemistry. In the case of manufacturing capabilities, outsourcing has incorporated upstream phases of the value chain, mainly the ones related to development activities. Eventually, innovation is boosted as products can reach the market in a faster way. The analysis demonstrates the core argument herein developed: by connecting distributed capabilities, outsourcing is a useful tool that accelerates innovation.

Au milieu du XIXe siècle les pharmaciens français ont le sentiment que leur monopole sur la vente et la fabrication de médicaments est de plus en plus menacé. Ils sont en effet de plus en plus dépendants, sur le marché, d’autres professions qui délivrent des produits en gros. C’est dans ce contexte de crise que la Pharmacie centrale de France, une coopérative d’achat et de production entre pharmaciens, est fondée en octobre 1852 par François-Louis-Marie Dorvault, lui-même pharmacien. L’étude de cette coopérative nous permet de mieux comprendre les liens entre l’industrie pharmaceutique et l’officine. Les historiens de la santé ont déjà très largement montré que l’industrie pharmaceutique contemporaine plongeait ses racines dans l’officine du XIXe siècle. Trop souvent cependant on réduit cette transition à celle d’acteurs individuels. Les historiens sociaux quant à eux ont souvent opposé la grande entreprise au petit commerce, l’émergence de l’un signifiant la disparition de l’autre. Le cas de la Pharmacie centrale de France est, de ce point de vue, original, qui offre à étudier une entreprise industrielle collective portée par des pharmaciens d’officine. Ce passage à l’industrie est perçu de façon positive et nécessaire par ces coopérateurs. Aux yeux de Dorvault, la naissance de la Pharmacie centrale va consolider l’officine dans ses fonctions commerciales et scientifiques. Elle n’a pas vocation à supplanter le pharmacien mais à le soutenir en lui permettant de mieux préparer et de vendre des produits de qualité achetés à moindre coût. Le capital de l’entreprise ne cesse de croître au cours de la période, passant de un million en 1852 à 5 millions en 1878. La Pharmacie centrale est également un succès commercial. Le chiffre d’affaires se situe à 400 000 francs en 1853 et 8 millions en 1878. La puissance de l’entreprise s’incarne à travers des bâtiments (usines de Paris et de Saint-Denis) et un réseau de succursales. La complexification du marché, la croissance de l’entreprise et les exigences de rentabilité, la concurrence féroce que se livrent les grossistes répartiteurs poussent cependant la PCF à rompre progressivement avec cette ligne. L’officine, tout en consolidant son monopole sur la vente au détail, voit disparaître les fondements de ce monopole, notamment l’élection (le choix des éléments naturels entrant dans la composition du médicament) et la préparation des produits. Les procédures de contrôle, la fabrication des produits, leur diffusion sont désormais centralisées par de grandes entreprises comme la Pharmacie centrale. La PCF accélère ainsi le passage de l’officine-laboratoire vers l’officine-comptoir. Par conséquent, la PCF a joué un rôle dans la redéfinition de l'identité professionnelle du pharmacien : une activité commerciale articulée autour d'un diplôme. La PCF a renforcé l'industrialisation de la pharmacie en amont et le monopole du pharmacien en aval. / In the middle of the nineteenth century the French pharmacists have the feeling their drug’s monopoly is threatened. They are more and more dependent towards other professions as druggists, herbalists. The Pharmacie centrale de France is a purchase co-operative between pharmacists founded by a Parisian pharmacist François-Louis-Marie Dorvault in october 1852. The PCF tries to achieve corporatist and industrial’s goals and allows us to understand the links between industry and the drugstore sector. Historians have already widely shown that the contemporary pharmaceutical industry derived from the pharmacy of the XIXth century. Too often however, we reduce this transition to individual actors. The social historians have often set the big company over against shopkeepers, the emergence of the first meaning the decline of the second. The case of the Pharmacie centrale de France is original on that account, which allows us to study an industrial co-operative between pharmacists. This transition to industry is perceived in a positive and necessary way by these co-operators. For someone like Dorvault, the Pharmacie centrale de France will strengthen the pharmacy in its commercial and scientific functions. The purpose of the co-operative is not to supplant the pharmacist but to sustain him, allowing him to prepare and to sell better medications bought at a lower cost. PCF’s capital never stops increasing during the period. From one million in 1852 the capital reaches 8 millions in 1878. The PCF is also a commercial success. Sales are estimated around 400 000 F in 1853 and 8 millions in 1878. The power of the company becomes incarnated through buildings (factories of Paris and Saint-Denis) and branches network. The PCF unfolds professional, social and scientific projects like the creation of a newspaper, the Union Pharmaceutique, in 1860; the scheme of a pharmacist’s pension fund between 1854 and 1859; the scheme of a drugstore’s insurance in 1863 and 1864; or the organization of scientific concourses. The market’s complexity, the growth of big company, the profitability’s imperatives, the fierce competition between wholesalers induce however the Pharmacie centrale to break gradually with this line. The pharmacy, while strengthening its sale’s monopoly, sees the foundations of this monopoly disappear, particularly the election (the choice of the natural elements entering the composition of the medicine) and the preparation of products. Control procedures, manufacturing, distribution are henceforth centralized by big companies as the Pharmacie centrale de France. The PCF accelerate the transformation of pharmacist’s work and the transition from preparation to sale only. In consequence, the PCF played a part in the redefinition of pharmacist’s professional identity: a commercial activity articulated around a degree. The PCF strengthened pharmacy’s industrialisation above and pharmacist’s monopoly below.

Submitted by Odilio Hilario Moreira Júnior (odilio@espm.br) on 2016-11-10T17:21:47Z No. of bitstreams: 1 Felipe Gonzalez Abuin.pdf: 924644 bytes, checksum: d88ecaadea656614106cf5f23152e874 (MD5) / Approved for entry into archive by Henrique Ribeiro (hribeiro@espm.br) on 2016-11-10T17:23:38Z (GMT) No. of bitstreams: 1 Felipe Gonzalez Abuin.pdf: 924644 bytes, checksum: d88ecaadea656614106cf5f23152e874 (MD5) / Approved for entry into archive by Odilio Hilario Moreira Júnior (odilio@espm.br) on 2016-11-10T17:25:35Z (GMT) No. of bitstreams: 1 Felipe Gonzalez Abuin.pdf: 924644 bytes, checksum: d88ecaadea656614106cf5f23152e874 (MD5) / Made available in DSpace on 2016-11-10T17:28:20Z (GMT). No. of bitstreams: 1 Felipe Gonzalez Abuin.pdf: 924644 bytes, checksum: d88ecaadea656614106cf5f23152e874 (MD5) Previous issue date: 2016-05-31 / This study goal to analyze the factors influence to choice of certain countries to carry out clinical research and elucidate an influence of different variables that were defined in this study. To meet the goal we use the quantitative methodology to create parameters for understanding how these studies are distributed by countries. The literature review contributed to the analysis and selection of the determining factors for the choice of where to conduct clinical research, defining the authors like Gehring (2014), Huijstee; Schipper (2011), Thiers (2007) and Swan; Robertson (2009) as a foundation to this study. The literature review enabled we did a list of twenty-two variables influencing the choice of where to conduct clinical research. All this variables are put together in seven categories: Freedom Business, Government of Freedom, Property Rights, Previous Experiences, Education Index, GDP and Costs . To this study we used the Institutional Theory by North (1990), Rodrik (1999), Rodrik and Subramanian (2002), applying through the economic freedom index of the base "The Heritage Foundation" and the “World Bank”. Global data about countries where they are developed clinical research were found in ClinicalTrials.org database. A regression in panel was implemented to goal to quantify the influence of each determining variable for the attraction of clinical research. This study is important to International Business, as clinical research is lucrative for the pharmaceutical industry. That makes many countries interest in receiving these studies and highlights all factors used for choosing where and why a particular country will be selected to carry out a clinical research. / O presente trabalho tem por objetivo analisar os fatores que levam a escolha de determinados países para a realização da pesquisa clínica e elucidar o peso entre as diferentes variáveis que foram delimitadas no presente trabalho. Para atender à proposta de trabalho fizemos uso de uma metodologia quantitativa para parametrizar a decisão locacional dos estudos clínicos. A revisão da literatura específica acerca do tema se fez necessária para a busca, análise e seleção dos fatores determinantes para a escolha de onde realizar a pesquisa clínica contribuindo assim, para que alcançássemos o objetivo proposto. Pesquisas qualitativas que utilizamos por base, como em Gehring (2014), Huijstee; Schipper (2011), Thiers (2007) e Swan; Robertson (2009) entre outros, permitiram a obtenção de uma lista com vinte e dois fatores responsáveis por influenciar a escolha de onde realizar a pesquisa clínica. Essas variáveis foram agrupadas em torno de sete categorias que levam os nomes das variáveis que irão compor a regressão em painel. São elas: Liberdade Empresarial, Liberdade de Governo, Direito de Propriedade, Experiências Anteriores, Índice Educacional, PIB e Custos. Foi utilizada a Teoria Institucional segundo North (1990), Rodrik (1999), Rodrik e Subramanian (2002), com aplicação por meio dos índices de liberdade econômica da base “The Heritage Foundation” e Banco Mundial. Os dados mundiais acerca dos países onde são desenvolvidas pesquisas clínicas foram obtidos na base de dados ClinicalTrials.org, uma base antiga que apresenta amplitude global. Uma regressão em painel desbalanceado foi implementada com o objetivo de quantificar a influência de cada variável determinante para a atração da pesquisa clínica. Esse estudo apresenta relevância para a área de Negócios Internacionais, pois a pesquisa clínica representa a criação de novas receitas para o setor farmacêutico. O que faz com que diversos países demonstrem interesse em receber essas pesquisas e coloca em evidência os critérios utilizados para a escolha de onde e por que um determinado país será selecionado para a realização da pesquisa clínica.