Academic literature on the topic 'Medicine and sanitary affairs'

O controle sanitário no Brasil merece elevado nível de consideração, pois caracteriza-se por grande importância social e econômica. Abrange um leque grande de produtos e serviços de diversas naturezas, como: medicamentos, alimentos, produtos biológicos, vacinas, hemoderivados, saneantes e desinfetantes, produtos de higiene pessoal, perfumes e cosméticos, controle dos portos, aeroportos, estações de fronteiras e uma ampla variedade de serviços à saúde. A Agência Nacional de Vigilância Sanitária (ANVISA) foi criada no Brasil especificamente conforme artigo 3º da Lei nº 9782/1999, sendo relativamente recente comparando-se com as agências regulatórias no âmbito internacional, e desde então evoluiu, angariando respeito no nível nacional e internacional. Outras agências reguladoras igualmente importantes abrangem variedades de produtos e serviços semelhantes à ANVISA. Inclusive a Food and Drug Administration - (FDA) e a European Medicines Agency (EMA) apresentam em seu \"rool\" de medicamentos os veterinários, enquanto que no Brasil este tipo de produto é regulamentado pelo Ministério de Agricultura, Pecuária e Abastecimento (MAPA). O processo de registro no sistema de vigilância sanitária é um recurso de grande valia para assegurar a comercialização de produtos seguros e eficazes disponíveis à sociedade. Qualquer falha na cadeia produtiva pode impactar nos critérios de qualidade. Assim, a regulamentação sanitária sobre medicamentos abrange toda a cadeia farmacêutica desde o início dos estudos de pesquisa clínica até normas referente à publicidade. O objetivo desse trabalho é contribuir na promoção do conhecimento de regulação sanitária para os medicamentos pelo estudo da estrutura organizacional e atribuições da ANVISA, e paralelamente, efetuar a análise e comparação da regulamentação sanitária entre as diferentes categorias de medicamentos, bem como discutir a estratégia regulatória adotada pelo setor farmacêutico. Como material dessa pesquisa, empregou-se essencialmente, a regulamentação sanitária farmacêutica nacional, tendo como contrapontos a situação política e econômica do país, pautando-se como método a pesquisa qualitativa utilizando-se do modelo documental. Com vistas à estrutura organizacional das agências reguladoras de medicamentos descritas neste trabalho, verificou-se semelhanças inerentes as concepções técnicas e regulatórias, diferenciando-se, principalmente, da brasileira pelo fato dos medicamentos de uso humano e veterinário não estarem contemplados sob a responsabilidade da mesma instituição. Dentre as sete categorias de medicamentos estudadas, a composição técnica de seus dossiês de registro são consideravelmente análogas, sendo distintas as exigências regulatórias tangíveis aos quesitos específicos inerentes a cada tipo de medicamento. No período analisado (2009 a 2010), com o intuito de retratar a tendência regulatória adotada pelo setor farmacêutico brasileiro, as categorias de medicamentos genéricos e similares são as que mais apresentaram solicitações e deferimentos de registros no país.<br>The sanitary control in Brazil deserves a high level of consideration, because it is characterized by large social and economic importance. It encompasses a wide variety of products and services of various natures, as medicines, food, biological products, vaccines, blood products, sanitizing and disinfectants, toiletries, perfumes and cosmetics, control of ports, airports, frontiers stations and an extensive variety of health services. The National Agency for Sanitary Surveillance (ANVISA) was created in Brazil specifically as Article 3 of Law No. 9782/1999 and is relatively recent compared with regulatory agencies internationally, and has since evolved, gaining respect in the national and international level . Other regulatory agencies equally encompass important varieties of products and services similar from ANVISA. Even the Food and Drug Administration - (FDA) and European Medicines Agency (EMA) in its present \"rool\" medicine veterinarians, while in Brazil this type of product is regulated by the Ministry of Agriculture, Livestock and Supply (MAPA). The registration process in health monitoring system is a very valuable resource to ensure that commercialization of safe and effective products available to society. Any failure in the supply chain can impact on the quality criteria. Thus, the sanitary regulation on medicines covers the entire pharmaceutical chain since the early clinical research studies relating to the advertising standards. The objective of this work is to contribute in promoting knowledge of sanitary regulation for medicines by studying the organizational structure and responsibilities of ANVISA, and in parallel, perform analysis and comparison of the sanitary regulation between different categories of medicines, as well as discuss the regulatory strategy adopted by the pharmaceutical industry. As material of this research, we used essentially the national pharmaceutical the sanitary regulation, having as counterpoints the political and economic situation of the country, basing itself as a qualitative research method using the model document. With views to the organizational structure of drug regulatory agencies described in this study, it was found similarities inherent in the concepts and techniques regulatory, differentiating itself mainly by the fact that the Brazilian medicines for human and veterinary use are not covered under the responsibility of the same institution. Among the seven categories of drugs studied, the technical composition of their registration dossiers are considerably analogous, with different regulatory demands tangible to specific questions related to each type of medicine. In the analyzed period (2009 to 2010), in order to portray the regulatory trend adopted by the Brazilian pharmaceutical sector, the categories of generic medicines and similar are the ones that submitted more requests for deferrals and registries in the country.

Mestrado em Biomedicina Farmacêutica<br>The present monograph intends to present a Regulatory Affairs department at a Multinational Pharmaceutical Company, as well as the role of the professionals working in that department. The experience which led to this monograph occurred after the conclusion of the curricular part of the Masters in Pharmaceutical Medicine, and was an opportunity to apply all the knowledge previously acquired and to develop new technical and personal skills. After the contextualisation of this document, the first chapter of this monograph introduce the Regulatory Affairs Professionals describing their principal responsibilities inside of the team. Following this, the principal activities developed by these professionals are described as well as how they interact with the different stakeholders. After framing the professional and the tasks developed, the structure of the modern Regulatory Affairs department is introduced and its impact on a Pharmaceutical Company is analysed. The following chapters promote a more personal view, showing the main activities developed during this professional experience and how the knowledge acquired prior and during it influenced the achieved results.<br>A presente monografia propõe apresentar um departamento de Assuntos Regulamentares de uma Empresa Multinacional Farmacêutica bem como o papel do Profissional que nele trabalha. A experiência que deu origem a esta monografia foi realizada após a conclusão da parte curricular do Mestrado em Biomedicina Farmacêutica, e foi uma oportunidade de aplicar todos os conhecimentos previamente adquiridos e de desenvolver novas competências técnicas e pessoais. Após a contextualização deste documento, o primeiro capítulo desta monografia introduz o Profissional de Assuntos Regulamentares, descrevendo as suas principais atividades dentro da equipa. De seguida, apresentam-se as atividades desenvolvidas por estes profissionais descrevendo-se como interagem com as diferentes partes envolvidas. Após o enquadramento do profissional e das atividades desempenhadas, introduz-se a estrutura de um departamento de Assuntos Regulamentares moderno e analisa-se o seu impacto numa empresa farmacêutica. Os seguintes capítulos promovem uma visão mais pessoal, mostrando as principais atividades desenvolvidas durante esta experiência e como os conhecimentos adquiridos antes e durante a mesma influenciaram os resultados adquiridos.

In the United States alone, there were 25.8 million people suffering from diabetes in 2010. The prevalence of diabetes is expected to markedly increase worldwide over the next 30 years, an estimated 2.8% in 2000 and 4.4% in 2030. For individuals diagnosed with type 2 diabetes mellitus (T2DM), treatment is essential to control adverse effects such as hypertension and diabetic neuropathy. The focus of this study is to examine various approaches to maintain and improve the lifestyle of individuals suffering from T2DM. A comparative approach has been used to evaluate the differences in the treatment of T2DM with the use of traditional Chinese medicine (TCM) and Western medicine. In Western society, pharmaceuticals are commonly used as a treatment method to manage hyperglycemia, along with life-style modifications. Furthermore, TCM views the human body and its functioning in a holistic way, stating that no single body part or symptom can be understood apart from its relation to a whole. Herbal medications and other treatments in TCM are targeted to treat underlying medical complaints that resulted in symptoms, instead of treating one specific manifestation. Data collection has been gathered through Qualitative over the phone interviews with patients suffering from T2DM, as well as TCM physicians. Interviews were conducted on patients that were diagnosed with T2DM (fasting plasma glucose levels of 126 or greater and HbAlc levels [greater than] 8%), and had continued treatment longer than three months prior to interviews. Collection of chart notes containing glucose levels, levels of pain, lifestyle changes, and vital signs were also used. A total of 21 patients from a family practice were interviewed, answering 23 constructed questions based on treatment of choice (TCM or western) and their personal input on treatment satisfaction. Patients varied in age, ethnicities, and gender, ranging from 39-70 years of age. Two traditional Chinese medicine physicians were also interviewed. Interviews with TCM physicians elaborated on course of treatment and steps taken to diagnose T2DM. Furthermore, prescription medications were also charted and documented to further analyze with secondary data. Upon completing the interviews, the data stated 21 patients (total population questioned) had not experienced alternative medicine and were exposed only to western medicine as treatment. A major concern for most patients were the pharmaceutical side effects, and 85.1% of patients stated they would be interested in an alternative treatment. Due to insufficient sources and knowledge on TCM treatment, 14.2% of patients stated they were satisfied with their western medicine treatment of choice and would not change treatment. The research's objective was to evaluate the differences in treatment of T2DM. Data collected supported the objective and showed the lack of sources to alternative treatments aside from western medicine. The researcher informed and educated interviewees about literature review on traditional Chinese medicine about alternative treatments available to treat T2DM.<br>B.S.<br>Bachelors<br>Helath Professions<br>Health and Public Affairs<br>Health Science Pre-Clinical

Made available in DSpace on 2014-11-10T11:09:54Z (GMT). No. of bitstreams: 0 Previous issue date: 2014-01-31Bitstream added on 2014-11-10T11:57:45Z : No. of bitstreams: 1 000791018.pdf: 1531884 bytes, checksum: ae4013aba1ff9092a7c8a61c550632bf (MD5)<br>A partir de 2005, a comissão do Codex Alimentarius deu início a uma nova empreitada no que diz respeito às práticas da inspeção ante e pós-morte, inserindo-as definitivamente nos planos de segurança e inocuidade. Recomenda-se, a adoção de métodos e técnicas de exames ou de análises que possuam enfoque ou características baseados no sistema APPCC (Análise de Perigos e Pontos Críticos de Controle – HACCP), que tem fundamentos científicos e caráter sistemático, permitindo identificar perigos específicos e medidas para seu controle - prevenção, redução ou eliminação, garantindo a inocuidade dos alimentos em margens de risco (Risk Analysis) aceitáveis internacionalmente. Este estudo visou à análise e a discussão das práticas vigentes durante a inspeção pós-morte de bovinos com base no monitoramento das ocorrências sanitárias durante o ano de 2012 e estudo retrospectivo da evolução dessas ocorrências entre os anos 2007 e 2011, com vistas à discussão e possível adequação dessas práticas com base nos requisitos e recomendações do Codex Alimentarius e do sistema de gestão de caráter preventivo definido pelo plano APPCC, focando-as em análises de risco. Nesse período, foram observados 17.981 casos de cisticercose (1,68%), 557 casos de linfadenite do tipo tuberculosa (0,05%), 1315 ocorrências de abscessos hepáticos (0,12%) e 235 casos de pneumonia (0,02%), num total de 1.067.584 animais abatidos. O índice geral para ocorrência de alterações sanitárias no exame pósmorte para o período foi de 1,9%, significando que dois em cada 100 animais abatidos demandam providências que salvaguardem a saúde dos consumidores. Embora pareça pequena, essa ainda é uma cifra muito elevada que impõe a necessidade do aprimoramento dos programas sanitários na exploração animal e sua efetiva adoção e responsabilização com base nas boas práticas de produção<br>Since 2005, the Codex Alimentarius committee began a new journey regarding the ante and post morten inspection practices, including this practice permanently at the security and safety plans. Methods and techniques tests adoption are recommended or analyze that have focus or characteristics based on HACCP program that have scientific fundamentals and systematic character that permit identify the specific hazard and measures for their control – prevention, reduction or elimination, ensuring the food safety in risk analysis international tolerable. This review aimed to analyze and discussion from adopted practices during the bovine post mortem inspection based on the sanitary occurrence monitoring during 2012, and based on retrospective study of these sanitary occurrences from 2007 to 2011, order to discuss and possible adequacy from these practices based on Codex Alimentarius requirements and recommendations. In this period were observed, 17.981 cases of cysticercosis (1,68%), 557 tuberculosis (0,5%), 13315 hepatic abscess (0,12%) and 235 pneumonia. (0,02%) in a total of 1.067.584 slaughtered animals. The general index to the sanitary changes occurrence at the post mortem exam at the period were 1,9%, what mean that each 100 animals slaughtered 2 need procedures to take care about customers heath safety. Although looks like a small quantity, it’s a big number that impose the necessity of the sanitary programs upgrading

Orientador: Luiz Francisco Prata<br>Banca: Estevam Guilherme Lux Hoppe<br>Banca: Paulo Sérgio Jorge<br>Resumo: A partir de 2005, a comissão do Codex Alimentarius deu início a uma nova empreitada no que diz respeito às práticas da inspeção ante e pós-morte, inserindo-as definitivamente nos planos de segurança e inocuidade. Recomenda-se, a adoção de métodos e técnicas de exames ou de análises que possuam enfoque ou características baseados no sistema APPCC (Análise de Perigos e Pontos Críticos de Controle - HACCP), que tem fundamentos científicos e caráter sistemático, permitindo identificar perigos específicos e medidas para seu controle - prevenção, redução ou eliminação, garantindo a inocuidade dos alimentos em margens de risco (Risk Analysis) aceitáveis internacionalmente. Este estudo visou à análise e a discussão das práticas vigentes durante a inspeção pós-morte de bovinos com base no monitoramento das ocorrências sanitárias durante o ano de 2012 e estudo retrospectivo da evolução dessas ocorrências entre os anos 2007 e 2011, com vistas à discussão e possível adequação dessas práticas com base nos requisitos e recomendações do Codex Alimentarius e do sistema de gestão de caráter preventivo definido pelo plano APPCC, focando-as em análises de risco. Nesse período, foram observados 17.981 casos de cisticercose (1,68%), 557 casos de linfadenite do tipo tuberculosa (0,05%), 1315 ocorrências de abscessos hepáticos (0,12%) e 235 casos de pneumonia (0,02%), num total de 1.067.584 animais abatidos. O índice geral para ocorrência de alterações sanitárias no exame pósmorte para o período foi de 1,9%, significando que dois em cada 100 animais abatidos demandam providências que salvaguardem a saúde dos consumidores. Embora pareça pequena, essa ainda é uma cifra muito elevada que impõe a necessidade do aprimoramento dos programas sanitários na exploração animal e sua efetiva adoção e responsabilização com base nas boas práticas de produção<br>Abstract: Since 2005, the Codex Alimentarius committee began a new journey regarding the ante and post morten inspection practices, including this practice permanently at the security and safety plans. Methods and techniques tests adoption are recommended or analyze that have focus or characteristics based on HACCP program that have scientific fundamentals and systematic character that permit identify the specific hazard and measures for their control - prevention, reduction or elimination, ensuring the food safety in risk analysis international tolerable. This review aimed to analyze and discussion from adopted practices during the bovine post mortem inspection based on the sanitary occurrence monitoring during 2012, and based on retrospective study of these sanitary occurrences from 2007 to 2011, order to discuss and possible adequacy from these practices based on Codex Alimentarius requirements and recommendations. In this period were observed, 17.981 cases of cysticercosis (1,68%), 557 tuberculosis (0,5%), 13315 hepatic abscess (0,12%) and 235 pneumonia. (0,02%) in a total of 1.067.584 slaughtered animals. The general index to the sanitary changes occurrence at the post mortem exam at the period were 1,9%, what mean that each 100 animals slaughtered 2 need procedures to take care about customers heath safety. Although looks like a small quantity, it's a big number that impose the necessity of the sanitary programs upgrading<br>Mestre

A personal health record (PHR) allows a patient to exert control over his/her healthcare by enhancing communication with healthcare providers. According to research, patients find value in having access to information contained in their medical records. Often a glossary is required to aid in interpreting the information and understanding the content. However, giving patients the ability to speak with providers about their medical conditions empowers them to participate as informed healthcare consumers. The majority of patients (75%) at Medical Specialists expressed their intention to adopt the PHR if it is made available to them. Although the perceived usefulness of a PHR was a significant determining factor, comfort level with technology, health literacy, and socioeconomic status were indirectly related to intention to adopt as well. Perceived health status was not found to be a significant factor in this population for determining intention to adopt a PHR. The majority of patients in each category of gender, age, marital status, and race/ethnicity (except American Indian/Alaska Native) expressed interest in adopting a PHR, with most categories being above 70%. Findings indicate a broad acceptance of this new technology by the patients of Medical Specialists. Improvement of adoption and use rates may depend on availability of office staff for hands-on training as well as assistance with interpretation of medical information. Hopefully, over time technology barriers will disappear, and usefulness of the information will promote increased demand.<br>ID: 028916585; System requirements: World Wide Web browser and PDF reader.; Mode of access: World Wide Web.; Thesis (Ph.D.)--University of Central Florida, 2010.; Includes bibliographical references (p. 160-172).<br>Ph.D.<br>Doctorate<br>Health and Public Affairs<br>Public Affairs

<p> Electrophysiological behaviors in cardiomyocytes, such as the action potential and calcium transient, are emergent properties arising from the interaction of an ensemble of ion channels, transporters, and pumps. In this Thesis, I integrate mathematical modeling with experiments to gain new insight into cardiac electrophysiology. Cardiomyocyte models are probed using population-based parameter sensitivity analysis to comprehensively generate quantitative predictions of how key behaviors are determined by the levels of ion channels, transporters, and pumps. Experimental tests ground these predictions in reality and provide opportunities for model improvement when predictions differ from experiments. In Chapter 2, this approach was applied to the determinants of calcium transient amplitude in rat cardiomyocytes. Experiments validated the unexpectedly large predicted effect of the transient outward potassium current on calcium transient amplitude in epicardial cardiomyocytes, but others demonstrated that the sarco/endoplasmic reticulum calcium ATPase had a much larger impact than predicted. Further exploration revealed that model calcium fluxes were inaccurately balanced, which we corrected to yield an improved model accurately reflecting our experiments and previous reports. In Chapter 3, the determinants of action potential duration in guinea pig cardiomyocytes predicted by parameter sensitivity analysis were tested using dynamic clamp, which found generally larger experimental effect sizes than predicted. We adjusted the model using a genetic algorithm to match our results, which led us to show that the overly stable model action potential resulted from higher levels of the slow delayed rectifier current than in our experiments. Subsequent analysis revealed how this current more effectively stabilizes the action potential than a related current, the rapid delayed rectifier. Finally, in Chapter 4 I take a global approach to model analysis, exploring competing models of the rabbit cardiomyocyte by comparing patterns of variability and correlations between behaviors across a population of models with randomly varied parameters. This found key experimentally testable differences between the models, representing a novel potential method for assessing how well these mathematical models represent the electrophysiological system of these cells. Overall, this work adds to our understanding of cardiac electrophysiology and represents a potential new paradigm for combining modeling and experiments to understand complex behaviors.</p><p>

Exposure to air pollution can cause adverse health effects, may also adversely affect the central nervous system and affect cognitive performance. Epidemiological studies depend on central site monitors as surrogates to assess personal exposure to air pollution, which can be inaccurate because they do not assess personal exposure in a variety of activities and microenvironments. This thesis aims to assess the level of misclassification in data from central site monitors by using portable modern sensors with high temporal resolution to characterize personal inhaled doses of BC, PM2.5, and UFP, and compare the measurements with surrogate exposure metrics. It also seeks to identify contributing activities and sources associated with the highest concentrations of the three pollutants, and to determine the contribution of these activities and microenvironments to personal exposure, and to study the impact of short-term exposure to air pollution on cognitive function. The first finding is that central site monitors are not a good surrogate for personal exposure. Secondly, travelling in vehicles is linked to the highest concentrations of the three pollutants, while other outdoors activities and outdoors commuting are linked to the highest concentrations of BC and PM2.5, cooking is linked to the highest concentrations of UFP, and activities and time spent indoors are the highest contributors to personal exposure. Thirdly, the results provide strong evidence that short-term exposure to PM2.5 from candle burning and commuting has an adverse effect on cognitive performance.

This study aims to investigate the physical properties of particles and their implications for source apportionment and health human exposure studies. A wide range of particle number size distribution (PNSD) measurements was conducted in selected environments using state-of-the-art high time resolution instruments. It is found that PNSD varied in different environments, depending on emission sources and atmospheric processes. A mass balance model was used to predict the penetration, infiltration factors, deposition and loss rates of indoor particles. The loss rates of indoor particles, which are mainly subject to deposition, coagulation and evaporation, were found to be a function of particle size and time. Moreover, HTDMA measurements were performed to study the hygroscopic properties of particles in outdoor and indoor environments, and from five major indoor sources. The particles emitted from indoor sources were mostly hydrophobic. An enhanced lung deposition model based on the ICRP and MPPD models was developed to predict the deposition fraction of particles in the human respiratory tract, with consideration of their hygroscopicity. Furthermore, a combination of lung deposition models and the PMF technique was applied to identify which sources are mostly responsible for deposited particles in the different regions of lung.