941 resultados para Multicriteria approval
Resumo:
Este artigo problematiza o acontecimento risco, em uma vertente histórica e política. Apresenta um panorama do debate sobre esta categoria analítica, desnaturalizando-a. Em uma segunda parte do texto, busca-se tecer uma descrição de como o acontecimento risco entrou em cena na política de proteção às crianças e aos jovens como modo estratégico de defesa social e prevenção. Em seguida, analisa-se como a gestão de riscos é materializada em práticas de conselheiros tutelares no Brasil, após a aprovação do Estatuto da Criança e do Adolescente. O conselho tutelar se torna um órgão central de gerência dos desvios em nome da proteção integral. Conclui-se que gerir riscos implica governar condutas a partir da lógica da sociedade de segurança.
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Este estudo avaliou o efeito de justificativas sobre o comportamento de seguir regras, quando foi construída uma história de reforço para não seguir regra. Dez crianças foram expostas a um procedimento de escolha segundo o modelo, cuja tarefa era tocar um de dois estímulos de comparação na presença de um estímulo contextual. Nas Condições I e II, as Fases 1, 2 e 4 eram iniciadas com a apresentação de instruções discrepantes das contingências programadas, cujo comportamento de segui-las produzia perda de fichas. Na Fase 3 era apresentada uma instrução correspondente com uma justificativa para seguir a instrução que produzia perda de fichas. A Condição I diferia da Condição II apenas com relação ao tipo de justificativa apresentada na Fase 3. Na Condição I era apresentada uma justificativa para ajudar crianças carentes e na Condição II uma justificativa que envolvia a aprovação do experimentador. O comportamento de nove dos 10 participantes ficou sob o controle da história de reforço para o não seguir instrução e das consequências imediatas produzidas pelo comportamento de não seguir instruções; o comportamento de um participante ficou sob o controle da justificativa para seguir a instrução correspondente.
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This manuscript provides an overview of past wildlife contraception efforts and discusses the current state of research. Two fertility control agents, an avian reproductive inhibitor containing the active ingredient nicarbazin and an immunocontraceptive vaccine, have received regulatory approval with the Environmental Protection Agency and are commercially available in the USA. OvoControl G Contraceptive Bait for Canada Geese and Ovo Control for pigeons are delivered as oral baits. An injectable immunocontraceptive vaccine (GonaCon Immunocontraceptive Vaccine) was registered with the Environmental Protection Agency for use in female white-tailed deer in September 2009. An injectable product (GonaCon Immunocontraceptive Vaccine) is registered for use in female white-tailed deer. Both products are labeled for use in urban/suburban areas where these species are overabundant. Several other compounds are currently being tested for use in wildlife in the USA, Europe, Australia and New Zealand that could have promise in the future. The development and use of reproductive inhibitors for resolving human–wildlife conflicts will depend on a number of factors, including meeting the requirements of regulatory agencies for use in the environment and on the biological and economical feasibility of their use. Use will also be dependent on health and safety issues and on public acceptance of the techniques.
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The Livestock Waste Management Act requires all livestock operations with 300 animal units or more to be inspected by the Nebraska Department of Environmental Quality (DEQ) to determine whether livestock wastes contaminate surface or ground water. This NebFact discusses the following parts of the Livestock Waste Management Act: Act (how cited); Terms (defined); Livestock operation, exemption, livestock waste control facility, permit, restriction; Construction permit or operating permit (when required), livestock waste control facilities, classification, restrictions; Section (how construed); Cold water class A streams (designation); Permit (acknowledgment required); Livestock operation (request inspection, when, fees, department, duties); Permits (duration, modification); Permit (application and modification fees, Livestock Waste Management Cash Fund (created, use, investment, report, legislative intent); Applicant (rejection, grounds, application, information required, certification required); Postconstruction inspection requirement; Department (contracts authorized, permit application, notice required); Permit application (approval from Department of Natural Resources and Department of Environmental Quality, powers); Council (rules and regulations); and Enforcement of act (legislative intent).
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I guess the impetus for laws in our state, really was the action of the city of Boston in 1963, when the Parks and Recreation Department felt that it was time to do something about massive populations of pigeons on the Boston Commons and in the city. The Parks Department came to our agency to find out what could be done. We immediately found as a result of a reorganization and recodification of the laws some 20 years before, that it was illegal to use or apply poisons for the purpose of killing any birds or mammals in the Commonwealth of Massachusetts. Property owners were given the privilege to destroy animals that were doing damage to their property, but only through mechanical means, certainly not by the use of toxicants. We helped the city of Boston draft a bill in 1963, which allowed our agency, the Division of Fisheries and Game, the agency responsible for all wildlife species in the state, the opportunity to issue certain permits for the use of poison, giving full authority to the director of Fisheries and Game with, of course, approval of my board. This allowed certain discretion on our part.
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This paper deals with the homologation process for obtaining carbon credits through the Clean Development Mechanism (CDM), that regulates the greenhouse gases reductions under the rules of the Kyoto Protocol. The CDM evaluates projects through a project cycle, which begins with the preparation of the Project Design Document (PDD) until the project certification to receive Certified Emission Reductions (CERs), popularly known as carbon credits. This study analyzed the implementation of the system Burner Recorder System for Low Flows of Biogas (QRBBV), developed by Marcelino Junior & Godoy (2009), in an eco-friendly wastewater treatment mini-plant (miniEETERA), built at the site of UNESP - Guaratinguetá SP. The QRBBV system is low cost and high reliability, developed to burn the methane generated at sites of low and variable production of biogas, which is not economically justified their energy recovery. Currently, almost all wastewater generated at the site of the campus is being treated by miniEETERA and, as a result, the biogas originated by this activity is being released into the atmosphere. Therefore, the project activity aims to capture and burn the biogas generated by miniEETERA, reducing the negative effects caused by the methane emissions into the atmosphere and, thus, claim to receive carbon credits. This work aimed to demonstrate the project applicability under CDM through the study and preparation of the PDD, as well as an analysis of the entire project cycle required for homologation. The result of the work obtained an estimate of only 20 CERs per year and proved to be economically unviable for approval through the CDM, since the spending with the approval process would not be compensated with the sale of CERs, mainly due the low carbon price in the world market. From an environmental standpoint, the project is perfectly... (Complete abstract click electronic access below)
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The first approach in this work is the concept of the electric power transmission and distribution system, as well as the survey of the current condition of substations chosen to thus identify the importance of having a suitable design with respect to security due to the need to obtain the approval for the operation of the substation according to the standards valid in the country. Present the guidelines and present needs when designing improvements, thus ensuring the company for more safety and reliability. From the company's point of view is an opportunity to reduce the cost of maintenance, and the professional point of view is an opportunity that allows a comprehensive study of legal requirements for the operation of substations
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The objective of this cross-sectional, descriptive study was to identify the activities of the Nursing Intervention Classification considered as priorities for an Ineffective Breathing Pattern and not performed for elderly inpatients of a teaching hospital in the state of Goias. The study participants were 43 nursing professionals, and data collection was performed in the period spanning October to December 2008, after receiving approval from the Ethics Committee. It was observed that among the 67 activities considered to be priorities for the referred diagnosis, only seven were performed by all of the participants; the other activities, with a varied frequency, were not performed, with the main reason cited being that a professional from a different area completed the activity. It is understood that the fact that the nursing staff does not perform these activities can cause lack of complete coverage in nursing care; therefore there is a need for a legal apparatus to describe the activities that comprise professional practice exclusive to nursing personnel and those activities that have an interdisciplinary nature.
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Cediranib is a potent inhibitor of the VEGF family receptor tyrosine kinases, and a new agent in cancer treatment. The drug has shown promising activity in a variety of solid malignancies, in preclinical models and in clinical trials. Its pharmacokinetics allow for a convenient once-daily administration, with a toxicity profile that is very similar to other VEGF inhibitors. Its main side effects include hypertension, nausea, dysphonia, fatigue and diarrhea. Adverse events seem to be manageable, especially when used in doses lower than 45 mg/day. Studies have shown some activity as a single agent or in combination in advanced tumors, but not enough to secure its approval for routine use up to now. Clinical trials are still evaluating the role of cediranib in combination chemotherapy with cytotoxic agents.
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PURPOSE: This study describes in Brazil and in the global biomedical community the time course of the development of animal research welfare guidelines. METHODS: The database of the Ethics Committee of the Faculty of Medicine of Ribeirao Preto (EC/FMRP-USP), Brazil, was surveyed since its inception in 2002 as the regulations became more stringent to provide better protection of animal research welfare at this institution. Medline database was evaluated to identify the number of publications in the period between 1968 and 2008 that used research animals and were in compliance with established ethics guidelines. RESULTS: The EC/FMRP-USP evaluated 979 projects up until 2009. Most of the applications came from Department of Physiology and the most frequently requested species was the rat. In 2004, national research funding agencies started to request prior approval from institutional review ethics committees prior to application review and this requirement became federal law in Brazil in 2008. The analysis of international publications revealed a relative reduction in studies involving research animals (18% in 1968 to 7.5% in 2008). CONCLUSIONS: The present work showed that in the last four decades major changes occurred in the guidelines dictating use of research animals occurred and they are being adopted by developing countries. Moreover, animal welfare concern in the scientific community preceded the introduction of journal guidelines for this purpose. Furthermore, in Brazil it was anticipated that laws were needed to protect animal research welfare from being not upheld.
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Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing stavudine (d4T) are reviewed. According to Biopharmaceutics Classification System (BCS), d4T can be assigned to BCS class I. No problems with BE of IR d4T formulations containing different excipients and produced by different manufacturing methods have been reported and, hence, the risk of bioinequivalence caused by these factors appears to be low. Furthermore, d4T has a wide therapeutic index. It is concluded that a biowaiver is appropriate for IR solid oral dosage forms containing d4T as the single active pharmaceutical ingredient (API) provided that (a) the test product contains only excipients present in the IR d4T drug products that have been approved in a number of countries for the same dosage form, and (b) both test product and its comparator are either very rapidly dissolving or rapidly dissolving with similarity of dissolution profiles demonstrated at pH 1.2, 4.5, and 6.8. (c) 2011 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:1016, 2012
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To report the radiological abnormalities of osteoarticular involvement in paracoccidioidomycosis (PCM). After institutional board approval, the medical records and conventional radiology findings of 19 patients with osseous PCM were retrospectively reviewed. Number, distribution, and lesion characteristics were evaluated in consensus by two experienced musculoskeletal radiologists. The mean age of patients was 16.1 years (range 4-49 years), 11 male and eight female. MSK involvement was the only or the primary presentation of the disease in eight of 19 patients (42.1%). In total, 51 focal bone lesions were detected, being 41 in long bones. In long bones lesions, 19 of 41 (46.4%) were metaphyseal, 12 of 41 (29.3%) meta-epiphyseal, and 12 of 41 (29.3%) diaphyseal. The most common presentation was a geographic osteolytic bone lesion (62.7%), without marginal sclerosis (82.4%) and without periosteal reaction (90.2%). Articular involvement was present in six of 19 patients (31.6%), being two cases of primary arthritis. All encountered bone lesions were osteolytic. Metaphyseal or meta-epiphyseal osteomyelitis of a long bone was the most prevalent osteoarticular manifestation of paracoccidioidomycosis. PCM osteoarticular involvement could be solitary or multifocal, occurs almost exclusively in the acute/subacute clinical form, and it is more common in children and in juvenile patients. Axial skeleton involvement, arthritis, or a disseminated osseous pattern of infection may occasionally occur in this fungal disease.
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Abstract Background Tobacco and cannabis use are strongly interrelated, but current national and international cessation programs typically focus on one substance, and address the other substance either only marginally or not at all. This study aimed to identify the demand for, and describe the development and content of, the first integrative group cessation program for co-smokers of cigarettes and cannabis. Methods First, a preliminary study using expert interviews, user focus groups with (ex-)smokers, and an online survey was conducted to investigate the demand for, and potential content of, an integrative smoking cessation program (ISCP) for tobacco and cannabis co-smokers. This study revealed that both experts and co-smokers considered an ISCP to be useful but expected only modest levels of readiness for participation.Based on the findings of the preliminary study, an interdisciplinary expert team developed a course concept and a recruitment strategy. The developed group cessation program is based on current treatment techniques (such as motivational interviewing, cognitive behavioural therapy, and self-control training) and structured into six course sessions.The program was evaluated regarding its acceptability among participants and course instructors. Results Both the participants and course instructors evaluated the course positively. Participants and instructors especially appreciated the group discussions and the modules that were aimed at developing personal strategies that could be applied during simultaneous cessation of tobacco and cannabis, such as dealing with craving, withdrawal, and high-risk situations. Conclusions There is a clear demand for a double cessation program for co-users of cigarettes and cannabis, and the first group cessation program tailored for these users has been developed and evaluated for acceptability. In the near future, the feasibility of the program will be evaluated. Trial registration Current Controlled Trials ISRCTN15248397
Resumo:
PURPOSE: This study describes in Brazil and in the global biomedical community the time course of the development of animal research welfare guidelines. METHODS: The database of the Ethics Committee of the Faculty of Medicine of Ribeirao Preto (EC/FMRP-USP), Brazil, was surveyed since its inception in 2002 as the regulations became more stringent to provide better protection of animal research welfare at this institution. Medline database was evaluated to identify the number of publications in the period between 1968 and 2008 that used research animals and were in compliance with established ethics guidelines. RESULTS: The EC/FMRP-USP evaluated 979 projects up until 2009. Most of the applications came from Department of Physiology and the most frequently requested species was the rat. In 2004, national research funding agencies started to request prior approval from institutional review ethics committees prior to application review and this requirement became federal law in Brazil in 2008. The analysis of international publications revealed a relative reduction in studies involving research animals (18% in 1968 to 7.5% in 2008). CONCLUSIONS: The present work showed that in the last four decades major changes occurred in the guidelines dictating use of research animals occurred and they are being adopted by developing countries. Moreover, animal welfare concern in the scientific community preceded the introduction of journal guidelines for this purpose. Furthermore, in Brazil it was anticipated that laws were needed to protect animal research welfare from being not upheld.
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The finished version of the human genome sequence was completed in 2003, and this event initiated a revolution in medical practice, which is usually referred to as the age of genomic or personalized medicine. Genomic medicine aims to be predictive, personalized, preventive, and also participative (4Ps). It offers a new approach to several pathological conditions, although its impact so far has been more evident in mendelian diseases. This article briefly reviews the potential advantages of this approach, and also some issues that may arise in the attempt to apply the accumulated knowledge from genomic medicine to clinical practice in emerging countries. The advantages of applying genomic medicine into clinical practice are obvious, enabling prediction, prevention, and early diagnosis and treatment of several genetic disorders. However, there are also some issues, such as those related to: (a) the need for approval of a law equivalent to the Genetic Information Nondiscrimination Act, which was approved in 2008 in the USA; (b) the need for private and public funding for genetics and genomics; (c) the need for development of innovative healthcare systems that may substantially cut costs (e.g. costs of periodic medical followup); (d) the need for new graduate and postgraduate curricula in which genomic medicine is emphasized; and (e) the need to adequately inform the population and possible consumers of genetic testing, with reference to the basic aspects of genomic medicine.