Inde | Page 52 | CRDI - Centre de recherches pour le ...

International Development Research Centre (IDRC) Digital Library (Canada)

Accueil · Asie du sud. Inde. Inde. Read more about Genetically Modified Organisms : Public Knowledge, Attitudes and Perceptions (India). Langue English. Read more about Connaissances, attitudes et perceptions de la population à l'égard des OGM en Inde. Langue French. Read more about Toward Détente in Media ...

21 CFR 60.34 - FDA action on petitions.

Science.gov (United States)

2010-04-01

... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... this section or investigate and determine under § 60.36 whether the applicant acted with due diligence during the regulatory review period. FDA will publish its due diligence determination in the Federal...

Inde | Page 35 | CRDI - Centre de recherches pour le ...

International Development Research Centre (IDRC) Digital Library (Canada)

Accueil · Asie du sud. Inde. Inde. Read more about Mondialisation de l'innovation : manifestation, déterminants et conséquences dans les économies émergentes de la Chine et de l'Inde. Langue French. Read more about Shifting Cultivation : Promoting Innovative Policy and Development Options in the Eastern Himalayas.

Indústria do conhecimento: uma poderosa engrenagem

OpenAIRE

Miguelote, Vera Regina da Silva; Camargo Jr, Kenneth Rochel de

2010-01-01

O artigo aborda a articulação da indústria farmacêutica à indústria do conhecimento, por meio de poderosas estratégias de marketing. Com o objetivo de legitimar cientificamente seus produtos, a indústria interfere na produção de conhecimento médico. Configurando uma engrenagem de direcionamento de interesses econômicos, financia pesquisas na área de medicamentos, enviesa seus resultados e incentiva a produção e publicação de artigos científicos. Trata-se de uma engrenagem que ameaça important...

Desigualdades na mortalidade por suicídio entre indígenas e não indígenas no estado do Amazonas, Brasil

Directory of Open Access Journals (Sweden)

Maximiliano Loiola Ponte de Souza

2013-12-01

Full Text Available OBJETIVO: Analisar as taxas e algumas características da mortalidade por suicídio entre indígenas e não indígenas no Amazonas. MÉTODO: Estudo de coorte retrospectiva, em que os dados de óbito foram obtidos no Sistema de Informações sobre Mortalidade e os populacionais no Instituto Brasileiro de Geografia e Estatística. Foram utilizados todos os registros de suicídio do período de 2006-2010 e a interpolação geométrica anual para a estimação das subpopulações. RESULTADOS: Ocorreram 688 suicídios no Amazonas, dos quais 19,0% em indígenas. A taxa ajustada de mortalidade por suicídio (TAMS nos indígenas, de 18,4/100 mil, foi 4,4 vezes superior a dos não indígenas. A TAMS em indígenas aumentou 1,6 vez em 2010 em relação a 2006. Nos municípios de Tabatinga e São Gabriel da Cachoeira, as TAMS foram muito altas, 75,8 e 41,9/100 mil, respectivamente. CONCLUSÕES: Evidenciou-se o comportamento desigual das taxas de mortalidade por suicídio entre indígenas e não indígenas, expondo não só sua importância local, como também sua invisibilidade como problema de saúde pública, principalmente entre jovens 15 e 24 anos.

Real-World Evidence, Public Participation, and the FDA.

Science.gov (United States)

Schwartz, Jason L

2017-11-01

For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.

EVA geen FDA

NARCIS (Netherlands)

Folbert, J.P.; Dagevos, J.C.

2001-01-01

De oprichting van een Europese Voedselautoriteit die in 2002 operationeel moet zijn. Velen zien hierin een evenbeeld van de Amerikaanse FDA (Food and Drug Administration). Deze instantie werkt echter niet zo ideaal als vaak wordt voorgesteld. Het belangrijkste verschil tussen beide instanties is de

IndElec: A Software for Analyzing Party Systems and Electoral Systems

Directory of Open Access Journals (Sweden)

Francisco Ocaña

2011-08-01

Full Text Available IndElec is a software addressed to compute a wide range of indices from electoral data, which are intended to analyze both party systems and electoral systems in political studies. Further, IndElec can calculate such indices from electoral data at several levels of aggregation, even when the acronyms of some political parties change across districts. As the amount of information provided by IndElec may be considerable, this software also aids the user in the analysis of electoral data through three capabilities. First, IndElec automatically elaborates preliminary descriptive statistical reports of computed indices. Second, IndElec saves the computed information into text files in data matrix format, which can be directly loaded by any statistical software to facilitate more sophisticated statistical studies. Third, IndElec provides results in several file formats (text, CSV, HTML, R to facilitate their visualization and management by using a wide range of application softwares (word processors, spreadsheets, web browsers, etc.. Finally, a graphical user interface is provided for IndElec to manage calculation processes, but no visualization facility is available in this environment. In fact, both the inputs and outputs for IndElec are arranged in files with the aforementioned formats.

FDA Drug Label Data

Data.gov (United States)

U.S. Department of Health & Human Services — This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number...

FDA and the Chemical Brain Drainers

DEFF Research Database (Denmark)

Grandjean, Philippe

2017-01-01

Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907......Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907...

FDA Recognized Consensus Standards

Data.gov (United States)

U.S. Department of Health & Human Services — This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information...

Derechos Humanos en Poblaciones Indígenas

OpenAIRE

Tuy, María del Carmen

2017-01-01

El tema que se me ha solicitado, Derechos Humanos en Poblaciones Indígenas, para Guatemala, puedo decir que es un tema del momento, ya que recientemente se firmó El Acuerdo de Paz Firme y Duradera, en donde en los diferentes acuerdos fueron tomados en gran parte los derechos de los Pueblos Indígenas, en este caso del pueblo Maya, Garífuna y Xinca

Haciendo desarrollo a lo indígena Proyectos de desarrollo en comunidades indígenas del Chaco salteño, Argentina

Directory of Open Access Journals (Sweden)

Natalia Castelnuovo Biraben

2014-01-01

Full Text Available A partir de una perspectiva etnográfica del proceso de implementación de un programa de desarrollo en comunidades indígenas, en el presente artículo nos proponemos dejar al descubierto los conflictos emergentes entre la Carta de cooperación firmada por el Estado argentino y el Banco Interamericano de Desarrollo, en cuanto es, por un lado, expresión de una episteme de la dominación y, por el otro, de una microfísica de la resistencia cotidiana desplegada por el Consejo de Caciques de los Siete Pueblos. El poder de negociación de la organización indígena la constituyó en broker de desarrollo, al implementar los distintos proyectos “a lo indígena”. El análisis de este proceso nos permite reflexionar acerca de las relaciones que pautan a las organizaciones indígenas con el Estado argentino y con los organismos de financiamiento internacional.

21 CFR 60.10 - FDA assistance on eligibility.

Science.gov (United States)

2010-04-01

... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in... in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852...

La participación de las comunidades indígenas migrantes en el marco del Consejo Consultivo Indígena en León, Guanajuato

Directory of Open Access Journals (Sweden)

Yolanda de León-de Santiago

2016-01-01

Full Text Available En México, a lo largo de la historia, se ha ignorado el aporte de los pueblos indígenas y se ha omitido su punto de vista para la toma de decisiones en asuntos que los atañe, no fue sino hasta el levantamiento Zapatista que la cuestión indígena despertó interés. En el estado de Guanajuato, la población indígena es menor en comparación con otros estados y, sin embargo, está conformada por un mosaico de culturas, algunas nativas y otras migrantes. A pesar de esto, la presencia de población indígena fue reconocida hasta el año 2004. El objetivo de este artículo es primeramente visibilizar la presencia de comunidades de indígenas migrantes en la ciu - dad de León, Guanajuato, y en segundo lugar, hacer un análisis de su participación ciudadana en el marco del Consejo Consultivo Indígena, como un mecanismo institucionalizado de atención para este segmento de la población.

The Regulatory Evaluation of Vaccines for Human Use.

Science.gov (United States)

Baylor, Norman W

2016-01-01

vaccine development process can be divided into two major categories: those events that are not under the regulatory authority of the FDA and are exploratory in nature and those events that are subject to regulatory authority by the FDA. Exploratory events or research and development cover basic research drug discovery processes that occur before the sponsor submits an investigational new drug application (IND) to the FDA. There are four main stages of vaccine development under the purview of regulatory authorities: preclinical, clinical (IND), licensing, and post-licensure. Throughout their life cycle from preclinical evaluation to post-licensure lot release testing, vaccines are subject to rigorous testing and oversight by manufacturers and NRAs. In this chapter an overview of the regulatory evaluation and testing requirements for vaccines is presented.

Jeroky Mbaekua - aspectos da etnoarte indígena.

Directory of Open Access Journals (Sweden)

Oseias de Oliveira

2015-06-01

Full Text Available A idéia de arte compartilhada na cultura ocidental tradicionalmente tem sido entendida a partir de elementos conceituais e categorizações que não podem ser aplicados na cultura indígena. Assim, considerar a arte indígena significa observar sua complexidade, de forma a perpassar todas as instâncias da vida desses sujeitos. Desta forma, o texto busca discutir aspectos da etnoarte indígena que não é focada em uma noção de arte centralizada e homogeneizadora mas, sim atenta à uma perspectiva que busca contemplar melhor o seu modo de construção de símbolos, significados e representações culturais.

Changes In Growth Culture FDA Activity Under Changing Growth Conditions

DEFF Research Database (Denmark)

Jørgensen, Per Elberg; Eriksen, Thomas Juul; Jensen, Bjørn K.

1992-01-01

The FDA hydrolysis capacities and bacterial biomass concentrations (estimated by determination of ATP content) of growth cultures prepared from activated sludge and wastewater, were measured to find out whether the FDA activity would reflect bacterial biomass under different physiological states...... of the bacteria. The FDA activity/ATP ratio was calculated for different concentrations of autoclaved sludge. A faster decay rate of ATP relative to FDA hydrolysis activity was observed, thus causing changes in the ratio. Furthermore, comparison between values obtained from pure cultures and different soils...... revealed differences up to two orders of magnitude of the ratio. Based on these results it was concluded that the FDA activity should not be applied for measurements of viable biomass in environments in which different physiological conditions occur....

Representantes y representaciones indígenas en el altiplano occidental de Guatemala

OpenAIRE

Celigueta, Gemma

2014-01-01

Este artículo se pregunta por la relación entre una representación política indígena y las representaciones existentes sobre dicho grupo. En concreto, demuestra la relación entre el concurso de Reina indígena del municipio de Quetzaltenango y la representación política indígena en la municipalidad. Además, los avatares del concurso permiten adentrarnos en el movimiento indígena de la segunda mitad del siglo XX. Un movimiento que plantea una redefinición de lo indígena y de su papel en las nac...

Subarray-based FDA radar to counteract deceptive ECM signals

Science.gov (United States)

Abdalla, Ahmed; Wang, Wen-Qin; Yuan, Zhao; Mohamed, Suhad; Bin, Tang

2016-12-01

In recent years, the frequency diverse array (FDA) radar concept has attracted extensive attention, as it may benefit from a small frequency increment, compared to the carrier frequency across the array elements and thereby achieve an array factor that is a function of the angle, the time, and the range which is superior to the conventional phase array radar (PAR). However, limited effort on the subject of FDA in electronic countermeasure scenarios, especially in the presence of mainbeam deceptive jamming, has been published. Basic FDA is not desirable for anti-jamming applications, due to the range-angle coupling response of targets. In this paper, a novel method based on subarrayed FDA signal processing is proposed to counteract deceptive ECM signals. We divide the FDA array into multiple subarrays, each of which employs a distinct frequency increment. As a result, in the subarray-based FDA, the desired target can be distinguished at subarray level in joint range-angle-Doppler domain by utilizing the fact that the jammer generates false targets with the same ranges to each subarray without reparations. The performance assessment shows that the proposed solution is effective for deceptive ECM targets suppression. The effectiveness is verified by simulation results.

Indígenas Antropólogos e o Espetáculo da Alteridade

Directory of Open Access Journals (Sweden)

Felipe Sotto Maior Cruz

2017-08-01

Full Text Available No presente artigo, apresento uma reflexão sobre a entrada de estudantes indígenas nas universidades brasileiras, enfatizando, a partir de minha experiência enquanto indígena antropólogo, o contexto dessa inserção em pós-graduações de antropologia. O meu foco de análise é a problemática que envolve a histórica invisibilidade indígena e os desafios de afirmação do protagonismo indígena nas academias frente às políticas de enunciação consolidadas nas práticas universitárias e à imagética nacional em torno da figura do “índio”.  Palavras-Chave: indígenas antropólogos, indígenas na universidade, educação indígena, indigenismo, relações interétnicas. Indigenous Anthropologists and the Spectacle of Otherness Abstract In this article I ponder on the access of indigenous students to Brazilian universities. From my own experience as an indigenous anthropologist, I focus on the context in which indigenous students are admitted to graduate programs in anthropology. I analyze the Indians' historical invisibility and the challenges they face to consolidate their roles in academy vis-à-vis the politics of enunciation that are deeply rooted in university practices and in the national imagery about the "Indian." Key Words: Indigenous anthropologists, University Indians, indigenous education, indigenism, interethnic relations. Indígenas Antropólogos y el Espectáculo de la Alteridad Resumen En el presente artículo presento una reflexión sobre la entrada de estudiantes indígenas en las universidades brasileñas, enfatizando, a partir de mi experiencia como indígena antropólogo, el contexto de esa inserción en los posgrados de antropología. Mi foco de análisis es la problemática que envuelve la histórica invisibilidad indígena y los desafíos de afirmación del protagonismo indígena en la academia frente a las políticas de enunciación consolidadas en las prácticas universitarias y la imagen nacional en

Regulating nanomedicine - can the FDA handle it?

Science.gov (United States)

Bawa, Raj

2011-05-01

There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle

76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

Science.gov (United States)

2011-01-07

...] FDA Transparency Initiative: Improving Transparency to Regulated Industry AGENCY: Food and Drug... the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The...

21 CFR 312.86 - Focused FDA regulatory research.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency...

Inde | Page 34 | CRDI - Centre de recherches pour le ...

International Development Research Centre (IDRC) Digital Library (Canada)

Accueil · Asie du sud. Inde. Inde. Read more about Reasoned Approach to Setting Priorities in Health. Langue English. Read more about Nanotechnology in South Asia : Building Capabilities and Governing the Technology in South Asia. Langue English. Read more about La nanotechnologie en Asie du Sud : renforcement ...

Indústria cultural e meio rural

Directory of Open Access Journals (Sweden)

VALDIR CASTRO OLIVEIRA

2012-06-01

Full Text Available Resumo – Este estudo discute de que maneira a indústria cultural interpela, nomeia e ressignifica as práticas sociais, políticas e culturais do meio rural através de contínuos deslocamentos semânticos dos quais emerge um rural idealizado e sem contradições. A nossa hipótese é a de que estas práticas discursivas são hegemonicamente determinadas e pautadas pelos interesses diretos ou conectados ao agronegócio e pelas suas potencialidades de consumo de bens materiais e simbólicos. Em conseqüência, definem também o conteúdo e as estéticas expressivas dos dispositivos comunicacionais voltados para o meio rural. Palavras-chaves – 1. Indústria cultural, 2. Comunicação Rural, 3. Indústria cultural e práticas discursivas para o meio rural. [1] Professor do Programa de Pós-Graduação em Comunicação e Informação para a Saúde. Fiocruz/ICICT. Rio de Janeiro. Endereço eletrônico: valdirco@yahoo.com.br

Educación indígena

Directory of Open Access Journals (Sweden)

Martha Rodríguez

2015-01-01

Full Text Available La sociedad ecuatoriana es multicultural y pluricultural. La educación de los indígenas debe ser la mayor prioridad.Ellos tienen que recuperar su espacio natural y ser dueños de su propio destino... y de los medios de comunicación.Describe el artículo como se concebía la educación desde la Colonia., la independencia y cuál fue el trato que se dio a los indígenas, los modelos educativos que se aplicaron, la educación formal, la educación bilingüe, los proyectos autogestionarios, la educación bilingüe intercultural.

An indigoidine biosynthetic gene cluster from Streptomyces chromofuscus ATCC 49982 contains an unusual IndB homologue.

Science.gov (United States)

Yu, Dayu; Xu, Fuchao; Valiente, Jonathan; Wang, Siyuan; Zhan, Jixun

2013-01-01

A putative indigoidine biosynthetic gene cluster was located in the genome of Streptomyces chromofuscus ATCC 49982. The silent 9.4-kb gene cluster consists of five open reading frames, named orf1, Sc-indC, Sc-indA, Sc-indB, and orf2, respectively. Sc-IndC was functionally characterized as an indigoidine synthase through heterologous expression of the enzyme in both Streptomyces coelicolor CH999 and Escherichia coli BAP1. The yield of indigoidine in E. coli BAP1 reached 2.78 g/l under the optimized conditions. The predicted protein product of Sc-indB is unusual and much larger than any other reported IndB-like protein. The N-terminal portion of this enzyme resembles IdgB and the C-terminal portion is a hypothetical protein. Sc-IndA and/or Sc-IndB were co-expressed with Sc-IndC in E. coli BAP1, which demonstrated the involvement of Sc-IndB, but not Sc-IndA, in the biosynthetic pathway of indigoidine. The yield of indigoidine was dramatically increased by 41.4 % (3.93 g/l) when Sc-IndB was co-expressed with Sc-IndC in E. coli BAP1. Indigoidine is more stable at low temperatures.

Indústrias criativas: definição, limites e possibilidades

OpenAIRE

Bendassolli,Pedro F.; Wood Jr.,Thomaz; Kirschbaum,Charles; Cunha,Miguel Pina e

2009-01-01

O termo "indústrias criativas" surgiu nos anos 1990, para designar setores nos quais a criatividade é uma dimensão essencial do negócio. As indústrias criativas compreendem, entre outras, as atividades relacionadas ao cinema, ao teatro, à música e às artes plásticas. Neste artigo introdutório, mostramos o surgimento do termo no âmbito de políticas públicas de desenvolvimento econômico, analisamos a literatura científica sobre as indústrias criativas e procuramos sistematizar as diferentes def...

78 FR 13067 - Agency Information Collection Activities: Proposed Collection; Comment Request; Foreign Clinical...

Science.gov (United States)

2013-02-26

... conducted under an IND as support for an IND or application for marketing approval for a drug or biological... and approval by an independent ethics committee (IEC). Under Sec. 312.120(a), FDA accepts as support for an IND or application for marketing approval a well-designed and well-conducted foreign clinical...

Gottlieb, the FDA and dumbing down medicine

OpenAIRE

Robbins RA

2017-01-01

No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some wh...

Aproximações do Movimento Indígena e os conflitos socioambientais: processos de resistência e violência a partir do olhar indígena

Directory of Open Access Journals (Sweden)

Maria da Graça Luderitz Hoefel

2013-12-01

Full Text Available Esta pesquisa documental busca identificar e analisar – a partir do olhar indígena – os processos de resistência, organização do Movimento Indígena e violência no contexto dos conflitos socioambientais indígenas, entre 2005 e 2012, vivenciados pelos povos Atikum, Kariri-Xocó, Potiguara, Pataxó Hã-Hã-Hãe e Truká, situados na região Nordeste do Brasil. Foram analisados 90 documentos aos quais aplicouse a matriz de análise de Hoefel et al. (2011. Nota-se que as cinco etnias enfrentam conflitos socioambientais semelhantes. Os assassinatos, atentados e perseguições às lideranças indígenas representam 43% do total de formas de violência identificadas, seguida pela apropriação de terras indígenas, que alcança 36%. A luta pelo território e a luta contra a violência – especialmente os homicídios e atentados – são as duas principais bandeiras de luta identificadas. Com relação às estratégias, o estudo indica que o acionamento do poder público (Executivo, Legislativo e Judiciário, as ocupações e denúncias na mídia caracterizam-se como as estratégias centrais adotadas nos processos de luta dos povos indígenas. Observa-se que a maioria dos conflitos são travados entre os povos indígenas e os grandes proprietários de terras, sinalizando, em verdade, uma disputa entre modelos de desenvolvimento e de sociedades absolutamente distintas. Nesse sentido, ressalta-se que a priorização da produção de commodities e de grandes obras de infraestrutura tem conduzido o Brasil a um processo paradoxal que, por um lado, favorece o crescimento do PIB e, por outro, aprofunda os conflitos socioambientais indígenas, acirra a violência e induz à redução de direitos constitucionais historicamente conquistados por estes povos.

Pluralismo jurídico: derecho indígena y justicia nacional

Directory of Open Access Journals (Sweden)

Leonello Bertini Chiriboga

2013-06-01

Full Text Available A partir de bases doctrinarias y normativas se analizan los avances y retrocesos de la jurisprudencia chilena en relación al reconocimiento de la costumbreindígena, la justiciabilidad del derecho propio indígena y la aplicación de un enfoque de pluralismo jurídico. Existen algunos avances en la jurisprudencia –a partir de la vigencia del Convenio 169 de la OIT– en el reconocimiento del derecho de propiedad ancestral al agua; derechos de uso, aprovechamiento y protección de tierras, recursos naturales y ecosistemas que conforman el hábitat territorial indígena; y derecho a la consulta acorde a la especificidad étnica de los pueblos indígenas. Sin embargo, en general, la jurisprudencia chilena salvaguarda la hegemonía del derecho estatal y los principios que lo estructuran, tanto en materia penal, donde excepcionalmente se aplica la costumbre como eximente o atenuante de responsabilidad penal, como en materia civil, donde se recogen tímidamente las normas y principios contenidos en la Ley Indígena y el Convenio 169 respecto del derecho de propiedad y posesión de las tierras de los pueblos indígenas. Por último, son inexistentes los casos de reconocimiento cierto de la potestad jurisdiccional de las autoridades indígenas para resolver los conflictos propios de su comunidad.

Gottlieb, the FDA and dumbing down medicine

Directory of Open Access Journals (Sweden)

Robbins RA

2017-04-01

Full Text Available No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some who say his deep ties to the pharmaceutical industry will cause a conflict of interest (1. Others praised Gottlieb as the right man to lead the FDA. As opposed to Trump, Gottlieb denied any connection between vaccines and autism (1,2. Dr. Gottlieb called the issue "one of the most exhaustively studied questions in medical history," before saying, "There is no plausible link between vaccines and autism. At some point, we have to accept 'no' for an answer." However, Gottlieb did not give a straight …

42 CFR 405.203 - FDA categorization of investigational devices.

Science.gov (United States)

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational.../investigational (Category A) or non-experimental/investigational (Category B). (c) CMS uses the categorization of...

FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files

Data.gov (United States)

U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...

Saúde reprodutiva e mulheres indígenas do Alto Rio Negro

Directory of Open Access Journals (Sweden)

Marta Azevedo

Full Text Available O presente artigo descreve e analisa as concepções próprias das mulheres indígenas do Alto Rio Negro sobre saúde reprodutiva, relacionando-as a indicadores de fecundidade. As informações qualitativas apontam para um conhecimento detalhado e complexo que as mulheres indígenas dessa região possuem sobre seu corpo e os cuidados com sua saúde. Os níveis e padrões etários da fecundidade estão relacionados com a etnia das mulheres, portanto, aos sistemas tradicionais de cuidados com a saúde desses povos. A pesquisa foi desenvolvida entre 1997 e 2003, na região de Iauaretê, Terra Indígena Alto Rio Negro (AM, e teve como primeira fonte de dados o Censo Indígena Autônomo do Rio Negro - CIARN-, levado a efeito pela Federação das Organizações Indígenas do Rio Negro - FOIRN - em 1992.

Situación de salud y nutrición de niños indígenas y niños no indígenas de la Amazonia peruana

Directory of Open Access Journals (Sweden)

Adrián Díaz

2015-07-01

Full Text Available OBJETIVO: Evaluar el estado nutricional de los menores de 5 años, indígenas y no indígenas, de dos provincias de la Amazonia peruana. MÉTODOS: Estudio descriptivo y transversal representativo de familias con niños menores de cinco años residentes en las provincias de Bagua y Condorcanqui en Perú. El estudio incluyó entrevista a la madre o cuidador del(os niño(s, evaluación antropométrica, hemoglobina en sangre capilar, búsqueda de parásitos intestinales en los niños menores de 5 años, acceso a los servicios de salud, antecedentes de infecciones respiratorias agudas y enfermedades diarreicas agudas, condición socioeconómica y consumo de sal inadecuadamente yodada. Mediante métodos lineares generalizados se identificaron los determinantes de la desnutrición crónica y anemia infantil en cada población de estudio. RESULTADOS: Se evaluaron 986 familias y 1 372 niños. La prevalencia de desnutrición crónica fue mayor en la población indígena respecto de la no indígena (56,2% versus 21,9%, igual que la anemia (51,3% versus 40,9%. Los determinantes de la desnutrición crónica fueron diferentes en ambas poblaciones. En indígenas, prevaleció la edad mayor a 36 meses (OR 2,21; IC95% 1,61-3, 04 y vivienda inadecuada (OR 2,9; IC95% 1,19-7,11, mientras que en los no indígenas, la pobreza extrema (OR 2,31; IC95% 1,50 - 3,55 y el parto institucional (OR 3,1; IC95% 2,00-4,83. CONCLUSIONES: Existen marcadas brechas entre la población indígena y la población no indígena respecto de las condiciones de vida, acceso a servicios de salud y estado nutricional de menores de 5 años. Se requiere asignar particular atención a la población indígena a fin de adecuar las modalidades de entrega de los programas y servicios que ofrece el Estado en dichos contextos.

Healthy public relations: the FDA's 1930s legislative campaign.

Science.gov (United States)

Kay, G

2001-01-01

In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more.

Programs of quality improvement: an exploratory study in large Brazilian construction companies

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Silvia Helena Boarin Pinto

2009-03-01

Full Text Available This article aims to identify the major characteristics of the implementation of quality programs in large construction companies in Brazil. This study focuses on the most accepted and implemented models such as ISO 9000:2000, ISO 14001, Six Sigma and Total Quality Management (TQM. An exploratory study was carried out in seven large companies (approximately 37% of the total number. These companies were chosen from the “500 Largest and Best Brazilian Companies” list, published by Exame Magazine, in 2005, out of a total number of 15 large companies in the sector. The indings of this study show that the companies have been implementing quality programs, have been using more basic quality tools, and have been dificulty accounting resources that come from the implementation of quality programs.

La participación de las comunidades indígenas migrantes en el marco del Consejo Consultivo Indígena en León, Guanajuato

OpenAIRE

Yolanda de León-de Santiago; Antonino Santiago-Isidro

2016-01-01

En México, a lo largo de la historia, se ha ignorado el aporte de los pueblos indígenas y se ha omitido su punto de vista para la toma de decisiones en asuntos que los atañe, no fue sino hasta el levantamiento Zapatista que la cuestión indígena despertó interés. En el estado de Guanajuato, la población indígena es menor en comparación con otros estados y, sin embargo, está conformada por un mosaico de culturas, algunas nativas y otras migrantes. A pesar de esto, la presencia de poblac...

FDA's requirements for radiation dosimetry of radiopharmaceutical drug products

International Nuclear Information System (INIS)

Abel, N.M.

1986-01-01

The primary concern of the Office of Drug Research and Review of the Food and Drug Administration in the field of radiation dosimetry is to ensure that radiopharmaceutical drug products are safe when used as investigational drugs (INDs) and are both safe and effective when a new drug application (NDA) is approved. In order to accomplish this, the sponsor of either an IND or applicant in the case of NDA must provide information that clearly describes the radiation dose that a patient will receive from the administration of the drug. The submitted numerical estimates of the radiation dose should be based on an absorbed fraction method of radiation dose calculation, such as the system set forth by the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine or the system set forth by the International Commission on Radiological Protection (ICRP). This presentation will describe in detail the data that a sponsor of an IND needs to submit to satisfy the regulatory requirements. Examples will be given of common mistakes and omissions by sponsors in their presentation of data

El laberinto de la autonomía indígena en el Ecuador: las circunscripciones territoriales indígenas en la Amazonía Central, 2010-2012

OpenAIRE

Ortiz-T., Pablo

2014-01-01

¿Cuáles son los avatares y desencuentros presentes en el proceso de constitución de las Circunscripciones Territoriales Indígenas (CTIs) en relación a la vigencia del derecho a la autodeterminación y autogestión territorial de las nacionalidades indígenas en el Ecuador? Para responder a dicha interrogante, el artículo considera el reconocimiento al derecho a la autonomía y autodeterminación de las nacionalidades y pueblos indígenas en Ecuador. Posteriormente, analiza el alcance...

La educación indígena en el Estado de México

OpenAIRE

Eduardo Andrés SANDOVAL-FORERO; Bernardino Jaciel Montoya Arce

2013-01-01

El artículo analiza de manera general el contexto nacional de la educación convencional indígena y de manera particular la educación indígena en el Estado de México a través de la información estadística del XIII Censo de Población y Vivienda 2010 y de los datos de la Dirección General de Educación Indígena. El examen de las cifras nacional y estatal evidencia en términos relativos un acceso restringido para los indígenas a la educación oficial, lo que demuestra mayor falta de ...

A formação do professor indígena

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Vanessa Nunes Ramos

2014-03-01

Full Text Available O artigo aborda a temática Formação do Professor Indígena e teve como objetivo destacar os desafios e avanços no processo de formação docente no Estado de Mato Grosso. A pesquisa teve uma análise qualitativa, baseada na pesquisa bibliográfica. Concluiu-se que o professor indígena tem como função principal contribuir para a formação integral de sua comunidade, atuando para além da sala de aula, ele contribui com o desenvolvimento econômico, político, social e cultural da comunidade. Palavras-chave: educação; formação do professor indígena; cultura.

Articulação da indústria farmacêutica brasileira com o exterior: há evidências de especialização regressiva? The Brazilian pharmaceutical industry and foreign trade: is there evidence of regressive specialization?

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Fábio Batista Mota

2012-03-01

Full Text Available Em caráter exploratório, o objetivo deste artigo é investigar se há indícios de especialização regressiva no padrão de comércio exterior da indústria farmacêutica brasileira, a partir da liberalização comercial dos anos 1990. Para tanto, foi realizada uma análise estatística descritiva valendo-se de dados de comércio exterior de produtos farmacêuticos e químicos orgânicos, disponíveis no sistema ALICEweb, do Ministério do Desenvolvimento, Indústria e Comércio Exterior, abrangendo os períodos 1989-1995 e 1996-2008. Os resultados, sobretudo a evolução do padrão de comércio com países desenvolvidos, sugerem indícios de especialização regressiva.Based on an exploratory discussion, the aim of this article is to investigate whether there is evidence of regressive specialization in the foreign trade pattern of the Brazilian pharmaceutical industry since trade liberalization in the 1990s. A descriptive statistical analysis drew on data for foreign trade in pharmaceutical and organic chemical products, available in the Aliceweb system of the Ministry of Development, Industry, and Foreign Trade, covering the periods 1989-1995 and 1996-2008. The results, especially concerning trends in Brazil's trade with developed countries, suggest evidence of regressive specialization.

Regulatory considerations concerning IND radiopharmaceutical drug products

International Nuclear Information System (INIS)

Nissel, M.

1985-01-01

The Food and Drug Administration is charged by the Food, Drug, and Cosmetic Act, as presently amended, to assure that any drug introduced into interstate commerce is safe and effective for the purposes for which it is labeled. A radiopharmaceutical is, by definition, a new drug unless there is in effect an approved New Drug Application (NDA) for it. Before the data for the NDA are compiled, investigative studies have to be done. Before such studies can be performed in humans, an exemption from the Act is necessary. This exemption, technically the Claimed Exemption for an Investigational New Drug, is termed the IND. Both the scientific and the administrative requirements for an IND are discussed. For radiopharmaceutical drug products (RDP's), the radiation hazards, as well as the pharmacological ones, must be documented. Should the early studies demonstrate a potential for efficacy in a certain condition or disease state, an investigative protocol for an extended clinical trial is presented. The necessary requirements for Institutional Review Board (IRB) approval and consent forms are discussed. For certain research purposes, uniquely for radioactive drugs, an IND is not required for certain specific studies; the requirements for such a research study, conducted under the auspices of an approved radioactive drug research committee, are outlined

La educación indígena en el Estado de México

OpenAIRE

Eduardo Andrés SANDOVAL-FORERO

2013-01-01

El artículo analiza de manera general el contexto nacional de la educación convencional indígena y de manera particular la educación indígena en el Estado de México a través de la información estadística del XIII Censo de Población y Vivienda 2010 y de los datos de la Dirección General de Educación Indígena. El examen de las cifras nacional y estatal evidencia en términos relativos un acceso restringido para los indígenas a la educación oficial, lo que demuestra mayor falta de oportunidades y...

Indústria 4.0 / Status Report Marc de referència sobre la Indústria 4.0 octubre 2016

OpenAIRE

Fonseca Casas, Pau

2016-01-01

L¿objecte d¿aquest document és donar a conèixer els elements de la Indústria 4.0 als enginyers, al teixit industrial català i a la societat, podent ser utilitzat com a instrument que faciliti el debat i la construcció d'un discurs normalitzat al voltant de la mateixa. Existeix el debat sobre fins a quin punt el màrqueting de la Indústria 4.0 va per davant de la realitat o a l¿inrevés. En qualsevol cas, l¿objectiu de la Comissió i4.0 d¿Enginyers de Catalunya és contribuir a l¿establiment de ba...

As práticas corporais e a educação do corpo indígena: a contribuição do esporte nos jogos dos povos indígenas

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Arthur José Medeiros de Almeida

2010-12-01

Full Text Available No presente estudo procurou-se analisar a relação entre o esporte e a educação do corpo indígena no contexto dos Jogos dos Povos Indígenas. O objetivo foi o de entender o significado do evento em relação ao sentido de educação do corpo indígena. Para tanto, realizou-se uma investigação com base nos pressupostos metodológicos das Ciências Sociais, combinando-se consulta a documentos com a o trabalho de campo, que ocorreu durante a IX edição dos Jogos dos Povos Indígenas. Nesse ínterim, a reflexão e a interpretação mostraram que o evento adquire conotação de espetáculo e que práticas corporais tradicionais assumem características do esporte de alto rendimento, podendo contribuir para o surgimento de outro habitus e modificar a relação dos indígenas com o uso de seu corpo.

FDA Approves First Therapeutic Cancer Vaccine

Science.gov (United States)

Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.

Addressing a Yellow Fever Vaccine Shortage - United States, 2016-2017.

Science.gov (United States)

Gershman, Mark D; Angelo, Kristina M; Ritchey, Julian; Greenberg, David P; Muhammad, Riyadh D; Brunette, Gary; Cetron, Martin S; Sotir, Mark J

2017-05-05

Recent manufacturing problems resulted in a shortage of the only U.S.-licensed yellow fever vaccine. This shortage is expected to lead to a complete depletion of yellow fever vaccine available for the immunization of U.S. travelers by mid-2017. CDC, the Food and Drug Administration (FDA), and Sanofi Pasteur are collaborating to ensure a continuous yellow fever vaccine supply in the United States. As part of this collaboration, Sanofi Pasteur submitted an expanded access investigational new drug (eIND) application to FDA in September 2016 to allow for the importation and use of an alternative yellow fever vaccine manufactured by Sanofi Pasteur France, with safety and efficacy comparable to the U.S.-licensed vaccine; the eIND was accepted by FDA in October 2016. The implementation of this eIND protocol included developing a systematic process for selecting a limited number of clinic sites to provide the vaccine. CDC and Sanofi Pasteur will continue to communicate with the public and other stakeholders, and CDC will provide a list of locations that will be administering the replacement vaccine at a later date.

Los dererchos humanos de las etnias indígenas en colombia

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Javier Ignacio Niño Cubillos

2005-01-01

Full Text Available El análisis de los mecanismos de protección de los derechos humanos de los pueblos indígenas exige un desarrollo epistemológico que permita reconocer su carácter pluriétnico y multicultural. Invita a una reflexión de las posturas occidentales del individualismo liberal y de los derechos colectivos en relación con los DH. Este desarrollo normativo parte de un momento histórico específico y plantea el carácter ambiguo de la globalización, ya que la homogenización cultural necesaria para la permeabilidad de los mercados factura la emergencia de los pueblos indígenas en defensa de sus identidades Este escenario se ilustra desde distintas aristas del caso colombiano, comenzando con el limbo legal de la Jurisdicción Especial Indígena hasta la manera diferenciada como las comunidades indígenas responden al conflicto armado o demandan políticas públicas que garanticen sus derechos

Mining FDA drug labels for medical conditions.

Science.gov (United States)

Li, Qi; Deleger, Louise; Lingren, Todd; Zhai, Haijun; Kaiser, Megan; Stoutenborough, Laura; Jegga, Anil G; Cohen, Kevin Bretonnel; Solti, Imre

2013-04-24

Cincinnati Children's Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration's (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system.

Environmental assessments and findings of no significant impact--FDA. Notice.

Science.gov (United States)

1998-05-18

The Food and Drug Administration (FDA) is announcing that it has reviewed environmental assessments (EA's) and issued findings of no significant impact (FONSI's) relating to the 167 new drug applications (NDA's) and supplemental applications listed in this document. FDA is publishing this notice because Federal regulations require public notice of the availability of environmental documents.

21 CFR 516.34 - FDA recognition of exclusive marketing rights.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive...

Narrativas Maxakali: possibilidades para o ensino de cultura e história indígena

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Pablo Luiz de Oliveira Lima

2013-09-01

Full Text Available O povo Maxakali enfrentou a colonização e resiste, até os dias de hoje, com a força de seus hábitos culturais. As narrativas indígenas são fontes ricas para o ensino de história, desde que trabalhadas adequadamente, respeitando a alteridade cultural, os diferentes conjuntos de valores, crenças e organização social dos povos indígenas. Este trabalho propõe um diálogo entre narrativas indígenas e teorias sobre a narrativa histórica. A presença de narrativas indígenas no ensino de História está relacionada às mudanças que ocorreram no ensino dessa disciplina a partir da década de 1980, com a instituição dos direitos indígenas constitucionais, novos parâmetros curriculares e uma legislação que tornou obrigatório o ensino de história e cultura indígenas na educação básica brasileira (Lei nº 11.645/08. A utilização de narrativas indígenas no ensino de história, além de levar os alunos a compreenderem melhor as culturas indígenas, pode leválos a percepções ampliadas sobre a sua própria cultura.

Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations

KAUST Repository

Xu, Liren; Zhang, Chen; Rungta, Meha; Qiu, Wulin; Liu, Junqiang; Koros, William J.

2014-01-01

This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family

Gas separation performance of 6FDA-based polyimides with different chemical structures

KAUST Repository

Qiu, Wulin

2013-10-01

This work reports the gas separation performance of several 6FDA-based polyimides with different chemical structures, to correlate chemical structure with gas transport properties with a special focus on CO2 and CH 4 transport and plasticization stability of the polyimides membranes relevant to natural gas purification. The consideration of the other gases (He, O2 and N2) provided additional insights regarding effects of backbone structure on detailed penetrant properties. The polyimides studied include 6FDA-DAM, 6FDA-mPDA, 6FDA-DABA, 6FDA-DAM:DABA (3:2), 6FDA-DAM:mPDA (3:2) and 6FDA-mPDA:DABA (3:2). Both pure and binary gas permeation were investigated. The packing density, which is tunable by adjusting monomer type and composition of the various samples, correlated with transport permeability and selectivity. The separation performance of the polyimides for various gas pairs were also plotted for comparison to the upper bound curves, and it was found that this family of materials shows attractive performance. The CO 2 plasticization responses for the un-cross-linked polyimides showed good plasticization resistance to CO2/CH4 mixed gas with 10% CO2; however, only the cross-linked polyimides showed good plasticization resistance under aggressive gas feed conditions (CO 2/CH4 mixed gas with 50% CO2 or pure CO 2). For future work, asymmetric hollow fibers and carbon molecular sieve membranes based on the most attractive members of the family will be considered. © 2013 Elsevier Ltd. All rights reserved.

Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations

KAUST Repository

Xu, Liren

2014-06-01

This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family with attractive dense film properties for several potential applications. The work reported here for the 6FDA-DAM polyimide provides insight for the challenging fabrication of defect-free asymmetric hollow fiber membranes for this class of 6FDA-polyimides, which behave rather different from lower free volume polymers. Specifically, the 6FDA based materials show relatively slow phase separation rate in water quench baths, which presents a challenge for fiber spinning. For convenience, we refer to the behavior as more "non-solvent resistant" in comparison to other lower free volume polymers, since the binodal phase boundary is displaced further from the conventional position near the pure polymer-solvent axis on a ternary phase diagram in conventional polymers like Matrimid® and Ultem®. The addition of lithium nitrate to promote phase separation has a useful impact on 6FDA-DAM asymmetric hollow fiber formation. 6FDA-DAM phase diagrams using ethanol and water as non-solvent are reported, and it was found that water is less desirable as a non-solvent dope additive for defect-free fiber spinning. Phase diagrams are also reported for 6FDA-DAM dope formulation with and without the addition of lithium nitrate, and defect-free asymmetric hollow fiber membranes are reported for both cases. The effect of polymer molecular weight on defect-free fiber spinning was also investigated. Gas transport properties and morphology of hollow fibers were characterized. With several thorough case studies, this work provides a systematic guideline for defect-free fiber formation from 6FDA-polymers. © 2014 Elsevier B.V.

Tuberculosis in indigenous children in the Brazilian Amazon Tuberculosis en niños indígenas en el Amazonas Brasileño Tuberculose em crianças indígenas da Amazônia brasileira

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Caroline Gava

2013-02-01

Full Text Available OBJECTIVE: Assess the epidemiological aspects of tuberculosis in Brazilian indigenous children and actions to control it. METHODS: An epidemiological study was performed with 356 children from 0 to 14 years of age in Rondônia State, Amazon, Brazil, during the period 1997-2006. Cases of TB reported to the Notifiable Diseases Surveillance System were divided into indigenous and non-indigenous categories and analyzed according to sex, age group, place of residence, clinical form, diagnostic tests and treatment outcome. A descriptive analysis of cases and hypothesis test (χ² was carried out to verify if there were differences in the proportions of illness between the groups investigated. RESULTS: A total of 356 TB cases were identified (125 indigenous, 231 non-indigenous of which 51.4% of the cases were in males. In the indigenous group, 60.8% of the cases presented in children aged 0-4 years old. The incidence mean was much higher among indigenous; in 2001, 1,047.9 cases/100,000 inhabitants were reported in children aged OBJETIVO: Evaluar los aspectos epidemiológicos de la tuberculosis en niños indígenas brasileños y las acciones para su control. MÉTODOS: Estudio epidemiológico con [356] niños de 0 a 14 años de edad, en Rondonia, Amazonas, Brasil, de 1997 a 2006. Los casos registrados en el Sistema de Información de Agravios de Notificación, se clasificaron en indígenas y no indígenas, y se analizaron según sexo, grupo etario, lugar de residencia, forma clínica, exámenes diagnósticos y resultado del tratamiento. Se realizó análisis descriptivo de los casos y prueba de hipótesis (χ² para verificar si hubo diferencias en las proporciones de la enfermedad entre los grupos investigados. RESULTADOS: Se identificaron 356 casos de tuberculosis (125 indígenas y 231 no indígenas, de los cuales, 51,4% en niños varones. En los indígenas, 60,8% de los casos fueron notificados en OBJETIVO: Avaliar os aspectos epidemiológicos da

Las organizaciones indígenas peruanas, pioneras de la educación intercultural bilingüe

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Alfredo Rodríguez Torres

2017-01-01

Full Text Available El artículo aborda de manera introductoria el problema de la educación básica de los pueblos indígenas amazónicos en el Perú y las iniciativas de las organizaciones indígenas amazónicas articuladas en la AIDESEP (Asociación Interétnica de Desarrollo de la Selva Peruana para el desarrollo de la educación superior indígena intercultural; sobre todo en las experiencias de formación inicial de maestros indígenas y de profesionales de la salud con un currículo intercultural y bilingüe desde la visión del “otro indígena”. El Estado peruano tardó años en asumir la formación de maestros interculturales bilingües y abordar la educación intercultural bilingüe (EIB como política pública, pero ambas con un enfoque tradicional y funcional que mantiene la colonialidad, aun así las organizaciones indígenas siguen aportando y apostando por una EIB desde la visión de los pueblos indígenas.

Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.

Science.gov (United States)

KuKanich, Butch; Warner, Matt; Hahn, Kevin

2017-02-01

OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.

Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.

Science.gov (United States)

Yu, Lawrence X; Baker, Jeffrey; Berlam, Susan C; Boam, Ashley; Brandreth, E J; Buhse, Lucinda; Cosgrove, Thomas; Doleski, David; Ensor, Lynne; Famulare, Joseph; Ganapathy, Mohan; Grampp, Gustavo; Hussong, David; Iser, Robert; Johnston, Gordon; Kesisoglou, Filippos; Khan, Mansoor; Kozlowski, Steven; Lacana, Emanuela; Lee, Sau L; Miller, Stephen; Miksinski, Sarah Pope; Moore, Christine M V; Mullin, Theresa; Raju, G K; Raw, Andre; Rosencrance, Susan; Rosolowsky, Mark; Stinavage, Paul; Thomas, Hayden; Wesdyk, Russell; Windisch, Joerg; Vaithiyalingam, Sivakumar

2015-07-01

On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.

FDA-approved small-molecule kinase inhibitors

DEFF Research Database (Denmark)

Wu, Peng; Nielsen, Thomas E.; Clausen, Mads Hartvig

2015-01-01

Kinases have emerged as one of the most intensivelypursued targets in current pharmacological research,especially for cancer, due to their critical roles in cellularsignaling. To date, the US FDA has approved 28 smallmoleculekinase inhibitors, half of which were approvedin the past 3 years. While...

Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men.

Science.gov (United States)

Underhill, Kristen; Morrow, Kathleen M; Operario, Don; Mayer, Kenneth H

2014-02-01

The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while others perceived approval as irrelevant or less significant than other sources of information. Our results suggest that FDA approval sends a signal that directly shapes PrEP acceptability among some MSM, while indirect influences of approval may affect uptake by others. Efforts to educate MSM about PrEP can increase acceptability by incorporating information about FDA approval, and outreach strategies should consider how this information may factor into personal decisions about PrEP use.

Juventud indígena en el Totonacapan Veracruzano

Directory of Open Access Journals (Sweden)

Ariel García Martínez

2012-01-01

Full Text Available El artículo pretende dar a conocer la especificidad de la juventud indígena de Totonacapan, su incorporación a la sociedad adulta y su interacción a través de un comparativo que toma como punto de partida la integración de los poblados pertenecientes a la sierra de Papantla, en el norte del estado de Veracruz, con el resto de la sociedad nacional. El trabajo intenta reconstruir el surgimiento de los “jóvenes indígenas” totonacos como producto de la interacción con su propia cultura y la cultura nacional en las cuatro últimas décadas.

Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.

Science.gov (United States)

McCall, W Vaughn; Benca, Ruth M; Rosenquist, Peter B; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Krystal, Andrew D

2017-01-01

Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.

21 CFR 312.48 - Dispute resolution.

Science.gov (United States)

2010-04-01

... division in FDA's Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research which is responsible for review of the IND, beginning with the consumer safety officer assigned to the... director of the division in FDA's Center for Drug Evaluation and Research or Center for Biologics...

Estudiantes no indígenas que ingresaron a la Licenciatura en Educación Indígena, sus actitudes y expectativas

Directory of Open Access Journals (Sweden)

MA. GUADALUPE MILLÁN DENA

2013-01-01

cumplían con el perfil de ingreso. Ello impactó en la modificación improvisada de la práctica docente de los asesores, en la búsqueda de nuevas estrategias didácticas y en la reestructuración de los programas. Primordialmente, se analizan las expectativas de formación y del campo laboral que los estudiantes no indígenas tenían cuando ingresan a la licenciatura. Uno de los aspectos más notorios con el ingreso de los alumnos “mestizos”, y que propició la realización de este trabajo, fue la actitud excluyente hacia los alumnos indígenas, que contrastaba con el discurso que expresaban.

Proyecto Vidas Paralelas Indígena: revelando el pueblo Fulni-ô de Pernambuco, Brasil

Directory of Open Access Journals (Sweden)

Eva Aurélia Melo SANTOS

2012-03-01

Full Text Available Este relato de experiencia se refiere al grupo étnico Fulni-ô, que habita la comunidad de Xixia-clá en el municipio de Águas Belas, a 300 km de Recife, Estado de Pernambuco, Brasil. Con respecto a su historia, se relata la unión con la tribu Carijós, y el declinio en el uso de la lengua ancestral, el Yaathê, del Saúde Indígena Tempus - Actas de Saúde Coletiva Revista Tempus Actas de Saúde Coletiva 58 tronco linguístico Macro-Jê. Se hace hincapié en el conflito de tierras, pues fue realizada una división en lotes que dejó a los indígenas un espacio muy limitado, siendo la ciudad fundada en territorio indígena. Se describe el liderazgo del Cacique y del Pajé, y la discusión en comunidad de los asuntos que interesan a los indígenas. A pesar de que todos ellos declaran profesar la religión católica, conocimientos ancestrales son trasmitidos y la ceremonia del Ouricury es muy concurrida. Se describe la atención a la salud, que cuenta con un puesto de salud, en donde trabajan indígenas en cargos compatibles con la educación en los niveles fundamental y medio. Los cargos de nivel superior son ocupados por no indígenas. El saneamiento básico aún está en proceso de implantación. La atención básica depende del Programa de Salud de la Familia Indígena (PSFI.

Evaluating eating behavior treatments by FDA standards

Directory of Open Access Journals (Sweden)

A. Janet eTomiyama

2014-01-01

Full Text Available Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require the patients’ time and investment, and may have risks. The Food and Drug Administration (FDA has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1 Is the treatment safe? (2 How dangerous is the condition the intervention is treating? (3 Is the treatment effective? (4 Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine.

76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

Science.gov (United States)

2011-05-24

... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...

Indígenas en la universidad brasileña: sueño, esperanza o pesadilla?

Directory of Open Access Journals (Sweden)

Josinaldo da SILVA

2012-03-01

Full Text Available Pensar en la presencia de indígenas en la enseñanza superior era, hasta hace poco tiempo, una utopía. Este artículo enfoca discusiones sobre la efectivación de las políticas de acciones afirmativas para indígenas en las universidades brasileñas, que son recientes no porque la población indígena no se haya manifestado, sino porque el país no tenía abertura para tal diálogo. La diversidade en la universidad ha contribuído para el diálogo y el entendimiento. Se narra que, para competir para los cupos, los candidatos indígenas necesitan comprobar su indianidad y firmar un término de compromiso con la comunidad indígena que los nomina. Ese proceso de identificación es complicado porque, ocasionalmente, debido a intercambio de favores, parientes de hacendados y políticos --ya privilegiados socialmente-- acaban utilizando los cupos. Los indígenas siempre estudiaron en escuelas públicas en situación precaria. Los autores relatan los problemas relacionados con la llegada a Brasilia y las dificultades generadas por la distancia de las aldeas. También se narran las experiencias de la convivencia en el ambiente universitario de la Universidad de Brasília, en dónde en algunos casos, la clase ignora y segrega a los estudiantes indígenas, y en otros, los docentes los ignoran o hasta se manifiestan contrarios a su presencia. Se cuestiona el papel de la Fundación Nacional del Indio (FUNAI. Aun frente a estas dificultades, los primeros indígenas comienzan a graduarse. Con orgullo y manteniendo vivas sus tradiciones, se espera el replanteamiento de la medicina occidental como complementaria a la medicina tradicional.

Justicia indígena en tiempos multiculturales: El caso del juzgado indígenas de Cuetzalan, Puebla en México

Directory of Open Access Journals (Sweden)

Adriana Terven Salinas

2014-12-01

Full Text Available A partir del reconocimiento constitucional de la diversidad cultural en México, las relaciones entre el Estado y los pueblos indígenas parecen tomar un cauce distinto a como habían venido configurándose, basadas en relaciones de poder y discriminación. No obstante, detrás del discurso multicultural se siguen reproduciendo representaciones sociales que otrora fueron legitimadas por las políticas indigenistas planteando retos para el cabal reconocimiento de derechos culturales. El presente artículo pretende evidenciar desde la experiencia del juzgado indígena de Cuetzalan, Puebla, cómo el proyecto estatal mantiene una misma intención: asegurar la permanencia del modelo monocultural de Estado, así como atender los nuevos imperativos internacionales de reforma estructural.

FDA actions against health economic promotions, 2002-2011.

Science.gov (United States)

Neumann, Peter J; Bliss, Sarah K

2012-01-01

To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading. We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to "health economic promotion," defined according to one of several categories (e.g., implied claims of cost savings due to work productivity or economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors such as the indication and type of media involved and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act. Of 291 DDMAC letters sent to pharmaceutical companies during the study period, 35 (12%) cited a health economic violation. The most common type of violation cited was an implied claim of cost savings due to work productivity or functioning (found in 20 letters) and economic claims containing unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters). The violations covered various indications, mostly commonly psychiatric disorders (6 letters) and pain (6 letters). No DDMAC letter pertained to Food and Drug Administration Modernization Act Section 114. The FDA has cited inappropriate health economic promotions in roughly 12% of the letters issued by the DDMAC. The letters highlight drug companies' interest in promoting the value of their products and the FDA's concerns in certain cases about the lack of supporting evidence. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Testamentos de indígenas americanos: siglos XVI - XVII

Directory of Open Access Journals (Sweden)

Pablo Rodríguez

2006-06-01

Full Text Available Este artigo pretende explicar o significado e as características dos testamentos indígenas registrados em diferentes regiões da América espanhola. A fonte principal do estudo são coleções documentais de testamentos publicadas no México, na Colômbia e no Chile. Também utiliza os estudos historiográficos que, com base nesses documentos, foram realizados no Equador e no Peru. O artigo abre uma nova janela à compreensão dos complexos processos econômicos, sociais e culturais vividos pelos povos indígenas a partir da conquista.

Revueltas indígenas en el Perú tardocolonial

OpenAIRE

Sala i Vila, Núria

1989-01-01

La hipótesis inicial que encauzó la investigación fue la búsqueda de un nexo entre la Gran Rebelión de 1780-81, aquélla que estalló en el Cuzco en 1814 y las luchas independentistas iniciadas a partir de 1820 con la llegada de las tropas del general San Martín al virreinato peruano. Consideré que el movimiento de Túpac Amaru no fue el final de un ciclo o etapa de lucha propiamente indígena y en consecuencia traté de demostrar la persistencia de respuestas violentas indígenas en la sociedad co...

Buen vivir y pueblos indígenas en Colombia

OpenAIRE

Rosa, Oscar David Montero de la

2017-01-01

ResumenA partir de la Constitución Política de 1991, Colombia se reconoce como un país multiétnico y pluricultural. Los 102 Pueblos Indígenas existentes en el país tienen como principios de lucha el Territorio, la Cultura, la Autonomía y la Unidad. Hoy el movimiento indígena colombiano, es un referente consolidado, a pesar del exterminio físico y cultural. Actualmente 36 pueblos están en riesgo de extinción, a raíz de las políticas estatales, el conflicto armado interno y el desarrollo occide...

Corporeidade indígena sob o ângulo da praxeologia

OpenAIRE

Soares, Artemis

2011-01-01

Neste estudo procumaos discutir a cororeidade indígena sob vários ângulos, incluindo a visão da praxiologia motriz. Sabemos que poucos estudos têm sido feitos sobre o corpo do indígena brasileiro e que estes muitas vezes nada propõem de novo, já que não conseguem ultrapassar certos limites, impostos pela sua própria condição de herdeiro de um pensamento que se propõe ser universalista. Alguns estudos sugerem novos elementos conceituais a serem desenvolvidos nas pesquisas de campo com popul...

Estratégias para Criação da Indústria Aeroespacial Brasileira

OpenAIRE

dos Santos, Isabel Cristina; Neto, João Amato

2007-01-01

A criação da indústria aeroespacial brasileira - defesa, aeronáutica e espaço - situa-se no processo de formação da indústria nacional, quando, na década de 1930, o modelo econômico fundamentado na produção agrícola é substituído, lenta e gradualmente pela produção industrial. Para prover recursos humanos, técnicos e tecnológicos necessários para atender as necessidades do modelo industrial que se formaria a partir de então, foram criadas algumas das principais indústrias e serviços de infra-...

Desigualdades na mortalidade por suicídio entre indígenas e não indígenas no estado do Amazonas, Brasil

OpenAIRE

Souza, Maximiliano Loiola Ponte de; Orellana, Jesem Douglas Yamall

2013-01-01

OBJETIVO: Analisar as taxas e algumas características da mortalidade por suicídio entre indígenas e não indígenas no Amazonas. MÉTODO: Estudo de coorte retrospectiva, em que os dados de óbito foram obtidos no Sistema de Informações sobre Mortalidade e os populacionais no Instituto Brasileiro de Geografia e Estatística. Foram utilizados todos os registros de suicídio do período de 2006-2010 e a interpolação geométrica anual para a estimação das subpopulações. RESULTADOS: Ocorreram 688 suicídio...

Etnoeducación Indígena Intercultural en el Caribe Colombiano

Directory of Open Access Journals (Sweden)

Clemente Mendoza Castro

2015-10-01

Full Text Available El ensayo resume un avance del proyecto “Estudios etnoeducativos y curriculares en el Caribe colombiano”, tiene el propósito de reflexionar sobre la etnoeducación en Colombia como aporte a la educación desde las prácticas pedagógicas de los etnoeducadores indígenas. Se analiza la historia de la etnoeducación indígena en Colombia y a manera de ejemplo sintetiza las experiencias etnoinvestigativas que se desarrollan en las escuelas indígenas de la Sierra Nevada de Santa Marta, La Guajira y el Atlántico, visibilizando la visión que tienen los maestros indígenas de etnoeducación y currículo, prácticas pedagógicas, etnoinvestigación, formando la aproximación de un programa etnoeducativo curricular pensado desde la realidad social e intercultural en el Caribe colombiano. Se propone con argumentación la aproximación a un modelo curricular integrado desde la etnoeducación indígena intercultural para el Caribe colombiano.AbstractThis essay summarizes an advance of the project Ethnoeducational and curricular studies in the Colombian Caribbean, and its purpose is to reflect on the ethnoeducation in Colombia as a contribution to the education from pedagogical practices of native ethnoeducators. The history of the native ethnoeducation in Colombia is analyzed and ethnoresearch experiences carried out in the native schools at Sierra Nevada de Santa Marta, Guajira and Atlántico are synthesized making evident teachers’ view on ethnoeducation and curriculum, pedagogical practices, ethnoresearch, and training. This is an approximation to an ethnoeducational and curricular program thought from the social and intercultural reality in the Colombian Caribbean. The approximation to a curricular integrated model from the intercultural native ethnoeducation for the Colombian Caribbean it is proposed with arguments.

Artes indígenas, patrimônio cultural e mercado

Directory of Open Access Journals (Sweden)

Ilana Seltzer Goldstein

2016-11-01

Full Text Available O sistema das artes vem se tornando cada vez mais internacional, com a formação de redes e fluxos. Entretanto, as criações populares e indígenas costumam ser ignoradas ou relegadas a segundo plano. A dicotomia arte versus artesanato é uma das estratégias de hierarquização desse sistema. O presente artigo aborda duas maneiras pelas quais as formas expressivas dos povos indígenas vêm sendo inseridas na sociedade envolvente: sua paulatina circulação no sistema das artes e seu recente reconhecimento como patrimônio cultural. A maioria dos dados é trazida da Austrália, país em que, a partir dos anos 1970, formou-se uma rede impressionante de fomento às artes indígenas, compreendendo premiações, alas especiais em museus, cooperativas de artistas e galerias comerciais nas grandes cidades. Nas páginas finais são abordados também exemplos brasileiros.

Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.

Science.gov (United States)

Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S

2011-01-01

Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Few physician-directed print pharmaceutical advertisements

Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.

Directory of Open Access Journals (Sweden)

Deborah Korenstein

Full Text Available Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA; adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14. Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1% adhered to all FDA guidelines, 41 (49.4% were non-adherent with at least one form of FDA-described bias, and 27 (32.5% were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.Few physician-directed print pharmaceutical

FDA regulations for commercial food irradiation

International Nuclear Information System (INIS)

Takeguchi, C.A.

1985-01-01

The Food and Drug Administration published an Advance Notice of Proposed Rulemaking (ANPR) on food irradiation on March 27, 1981 (FDA, 1981). The next step in the rulemaking process is a proposed rule that will deal with low-dose irradiation of certain foods and high-dose irradiation of spices. The status of the proposed regulation is discussed

Narrativas sobre la conducta suicida en pueblos indígenas colombianos, 1993-2013

Directory of Open Access Journals (Sweden)

Zulma C. Urrego-Mendoza

2017-09-01

Full Text Available Objetivo: comprender la conducta suicida que ha afectado a los pueblos indígenas de Colombia y sus procesos de determinación social, durante el periodo 1993-2013. Metodología: a partir de fuentes orales y de prensa escrita, esta investigación cualitativa fue desarrollada desde el paradigma hermenéutico-interpretativo, empleando análisis narrativo. Resultados: se evidencian manifestaciones de conducta suicida en pueblos indígenas no solo como acciones recientes, sino remitidas a hechos históricos, especialmente durante la Colonia, cuando el suicidio colectivo se empleó como repertorio de resistencia frente a la invasión y opresión. Actualmente, la emergencia de la conducta suicida en estos pueblos responde a problemas estructurales, a procesos sociales impuestos que se contraponen con las cosmovisiones indígenas, alterando sus concepciones de vida y de interacción con el territorio. Discusión: para los pueblos indígenas de Colombia, la interpretación más cercana a este problema está asociada con la exacerbación de seres y existencias espirituales que alteran el orden del territorio, desatados a partir de procesos perturbadores foráneos, tales como la presencia de actores armados, empresas transnacionales, colonos, violencia directa y estructural sobre indígenas y despojo territorial. Conclusiones: la conducta suicida en los pueblos indígenas de Colombia debe comprenderse y abordarse como el emergente de procesos estructurales destructivos de los modos de vida propios, que aseguran el buen vivir individual y colectivo de los pobladores originarios, y se ven coartados por la irrupción violenta de la sociedad mayoritaria en sus territorios.

Benchmarking e a indústria do conhecimento: um estudo de caso

OpenAIRE

Maciel Filho, Adalberto Rego; Aquino, Miriam Cunha de; Sales, Nayade Kennedy

2016-01-01

Resumo Estudo de caso das Bibliotecas Indústria do Conhecimento (IDCs) do sistema do Serviço Social da Indústria-Sesi localizadas em Alagoas (25), Paraíba (10),Pernambuco (18), Rio Grande do Norte (10), especificamente as IDCs Públicas, objetivando analisar o seu desempenho e apresentar oportunidades para incremento de frequência utilizando benchmarking. Inclui revisão de literatura de projetos nacionais de uso de benchmarking, bem como estudos e considerações sobre esse processo. Para anális...

A inserção externa da indústria brasileira de defesa: 1975-2010

OpenAIRE

Moraes, Rodrigo Fracalossi de

2012-01-01

O texto analisa o histórico da inserção externa da indústria brasileira de defesa e o papel que o mercado externo desempenhou - e pode vir a desempenhar - para esta indústria. Demonstra-se que, para um país no qual as aquisições internas de equipamentos militares são relativamente baixas como o Brasil, as exportações desempenham papel essencial à manutenção de uma indústria de defesa economicamente viável - ou seja, que possa produzir itens com custos unitários não muito elevados e seja capaz...

FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology.

Science.gov (United States)

Grant, Evita V

Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations.

Derechos humanos de los pueblos indígenas: Panorama colombiano

OpenAIRE

Omar Huertas; Danilo Ortíz

2009-01-01

La crisis de los derechos humanos que sufre Latinoamérica se ve reflejada en la cantidad significativa de pueblos indígenas, que pertenecen a estos países, sometidos a procesos de discriminación, despojo, neoliberalismo económico y globalización. Estas circunstancias han condenado a estas comunidades al subdesarrollo y a una grave situación que pone en riesgo su existencia. En el presente artículo se hará unanálisis de la situación de los derechos de la población indígena en Colombia, teniend...

Educación, Identidad y Derechos como estrategias de desarrollo de los Pueblos Indígenas. II Decenio de los Pueblos Indígenas 2005-2015.

OpenAIRE

Gehrig, Rainer; Muñoz Sánchez, Práxedes

2015-01-01

A continuación presentamos en resumen los contenidos del libro en sus 15 capítulos divididos en tres partes temáticas. Estas deben entenderse como círculos concéntricos con sus solapamientos. Son como tres grandes hilos conductores de los capítulos desarrollados en esta publicación que abarca diferentes perspectivas: 1. Educación y cooperación como reto de Desarrollo comunitario en contextos indígenas; 2. Identidad cultural y Derechos de los Pueblos indígenas y 3. Interculturalidad, Evangeliz...

A indústria têxtil na região nordeste: gargalos, potencialidades e desafios

Directory of Open Access Journals (Sweden)

Fernando Luiz Emerenciano Viana

2008-10-01

Full Text Available Este trabalho apresenta uma avaliação da competitividade da Indústria Têxtil na Região Nordeste, bem como uma relação de gargalos, potencialidades e desafios. As observações foram feitas a partir de pesquisa bibliográfica e documental. Foram realizadas análises da indústria têxtil no âmbito brasileiro e mais detalhadamente no campo de atuação nordestino. Os estados do Ceará, Bahia, Paraíba e Rio Grande do Norte destacaram-se na produção e no número de empregos no setor. Questões logísticas ligadas à integração e adensamento da cadeia produtiva a partir da articulação com a indústria de confecções, infra-estrutura e modernização tecnológica são apontadas como temas recorrentes ao alavancamento da Indústria na Região.

Small-molecule kinase inhibitors: an analysis of FDA-approved drugs

DEFF Research Database (Denmark)

Wu, Peng; Nielsen, Thomas Eiland; Clausen, Mads Hartvig

2016-01-01

Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and ther......Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function...

Jóvenes indígenas y relatos sobre escolaridades en la Universidad Pedagógica Nacional

Directory of Open Access Journals (Sweden)

Gabriela Czarny

2016-04-01

Full Text Available El texto pretende contribuir a la comprensión de los entrecruzamientosy las complejidades presentes bajo categorías homogeneizantescomo la de “jóvenes estudiantes indígenas” en la educación superior.En particular, en torno de la presencia indígena en la UniversidadPedagógica Nacional, Ajusco, (UPN, Ajusco en la ciudad de México,en donde opera desde 1982 el programa de Educación Indígena, marcavisible de lo étnico en la universidad. Retomo los textos de autoríade jóvenes indígenas, producidos durante un ejercicio colectivo conellos en la universidad, en los que identifico heterogeneidades en susadscripciones comunitarias, como así también en los modos de autopresentarsey definirse. Como parte del análisis considero algunos delos debates que atraviesan este campo de estudio, entre ellos, el conceptode indígena migrante al interior del país, el modo de caracterizara los indígenas y las comunidades en las ciudades, y los sentidos -entensión para los jóvenes-, que adquiere la educación superior. Se tratade ubicar en la agenda educativa, la comprensión de que estos temasresultan retos académicos, sociales y políticos para la transformaciónde las sociedades multiétnicas como las latinoamericanas, así comopara las instituciones de educación superior que reciben cada vez másestudiantes indígenas con diversas adscripciones socioculturales, étnicas,lingüísticas.

Microdose clinical trial by use of radioisotope and perspective of its possible utilization in drug development

International Nuclear Information System (INIS)

Yano, Tsuneo; Watanabe, Yasuyoshi

2009-01-01

Many promising PET tracers have been developed by the progress of molecular imaging research, and new era could be opened by clinical trials using investigational products labeled by RI. Guidance for microdose clinical trial issued by MHLW in June, 2008, is the regulatory basis to develop PET tracer under clinical trial by the pharmaceutical affairs law. In this review, the discussion from the aspect of regulatory science is highlighted, particularly, on the topics of guidance for microdose and exploratory IND study including sub-therapeutic dose (type II) and therapeutic dose (type III), the revised GMP for investigational product including RI-labeled product, and to ward guidance for microdose clinical trial for biological product. Finally, the US FDA guidance developing medical imaging drug including biological product is introduced, and then perspective of possible utilization of in vivo radiopharmaceutical agents in drug development is discussed. (author)

FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing Technologies.

Science.gov (United States)

Wilson, Carolyn A; Simonyan, Vahan

2014-01-01

Applications of next-generation sequencing (NGS) technologies require availability and access to an information technology (IT) infrastructure and bioinformatics tools for large amounts of data storage and analyses. The U.S. Food and Drug Administration (FDA) anticipates that the use of NGS data to support regulatory submissions will continue to increase as the scientific and clinical communities become more familiar with the technologies and identify more ways to apply these advanced methods to support development and evaluation of new biomedical products. FDA laboratories are conducting research on different NGS platforms and developing the IT infrastructure and bioinformatics tools needed to enable regulatory evaluation of the technologies and the data sponsors will submit. A High-performance Integrated Virtual Environment, or HIVE, has been launched, and development and refinement continues as a collaborative effort between the FDA and George Washington University to provide the tools to support these needs. The use of a highly parallelized environment facilitated by use of distributed cloud storage and computation has resulted in a platform that is both rapid and responsive to changing scientific needs. The FDA plans to further develop in-house capacity in this area, while also supporting engagement by the external community, by sponsoring an open, public workshop to discuss NGS technologies and data formats standardization, and to promote the adoption of interoperability protocols in September 2014. Next-generation sequencing (NGS) technologies are enabling breakthroughs in how the biomedical community is developing and evaluating medical products. One example is the potential application of this method to the detection and identification of microbial contaminants in biologic products. In order for the U.S. Food and Drug Administration (FDA) to be able to evaluate the utility of this technology, we need to have the information technology infrastructure and

El estatuto legal y social de las lenguas en la educación indígena mexicana

Directory of Open Access Journals (Sweden)

Dalia Ruiz Ávila

2002-01-01

Full Text Available En este documento se propicia una reflexión acerca de la forma en que la inmersión de las lenguas indígenas en preceptos de carácter legal y social confiere una dinámica particular a la realización de la educación formal destinada a amplios sectores de la población mexicana. Las interrogantes que se plantean a lo largo de la exposición son: ¿Cómo se traduce lo asentado en el plano jurídico en relación con el indígena en el marco de la educación indígena?, y ¿cómo se introduce la representación social del indígena en la educación formal diseñada para ellos? Para un acercamiento a las respuestas se indaga en los documentos oficiales que abordan el tema, en la revisión de datos censales y en algunos elementos teórico-metodológicos de la educación, las ciencias del lenguaje y la antropología. Las premisas de las cuales se parte son: 1 el auge de los movimientos indígenas ha golpeado a la hegemonía de las posiciones multiculturales y asimilacionistas; 2 los pueblos indígenas se han instalado como actores sociales en los escenarios políticos, y 3 la cuestión indígena no es un problema marginal. Exige una reforma del Estado y la participación de la sociedad civil. Un análisis fundamentado en la categoría de formación imaginaria propuesta por Michel Pécheux1 permite un acercamiento a la caracterización del sujeto indígena por sí mismo; del otro, sea o no indígena y del referente; es decir, de lengua y cultura. De éste se desprende que es necesaria una reformulación del estatuto legal, que sea acorde con los requerimientos de los diversos grupos indígenas, con el reconocimiento a la diversidad cultural.

Notas sobre a indústria do entretenimento musical e identidade no Brasil

Directory of Open Access Journals (Sweden)

Simone Pereira de Sá

2008-09-01

Full Text Available O artigo aborda questões ligadas à indústria de música de massa no Brasil, articuladas à identidade e à crítica jornalística. Abstract: The article focus on questions about the massive musical industry on Brazil, articulated to identity and journalism criticism. Palavras-chave: indústria cultural; música massiva; identidade; crítica jornalística Key-words: cultural industry; massive music; identity; journalistic criticism

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

International Nuclear Information System (INIS)

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

Energy Technology Data Exchange (ETDEWEB)

NONE

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

Conducta suicida en pueblos indígenas: una revisión del estado del arte

OpenAIRE

Vargas-Espíndola, Alejandra; Villamizar-Guerrero, Juliet Catherine; Puerto-López, Jhon Sebastián; Rojas-Villamizar, Manuel Ricardo; Ramírez-Montes, Omar Santiago; Urrego-Mendoza, Zulma Consuelo

2017-01-01

Resumen Introducción. Se realizó una revisión documental en bases de datos sobre conducta suicida en pueblos indígenas, tipo estado del arte, que la identificara como un problema de salud pública. Objetivo. Sistematizar el estado del conocimiento que se construye sobre la conducta suicida en pueblos indígenas, a partir de artículos e informes de investigación publicados hasta 2014. Materiales y métodos. Revisión documental de 149 documentos publicados sobre conducta suicida en pueblos indí...

Evidence behind FDA alerts for drugs with adverse cardiovascular effects: implications for clinical practice.

Science.gov (United States)

Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen

2014-01-01

The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications. © 2013 Pharmacotherapy Publications, Inc.

A presença feminina nas indústrias de lingerie na cidade de Franca

OpenAIRE

Pereira, Mayara C. Freitas; Bueno, Cléria M. L. Bittar Pucci

2008-01-01

Dados recentes nos comprovam que as indústrias de lingerie têm apresentado considerável crescimento na cidade de Franca/SP, cuja história sempre se pautou pela indústria do calçado. Devido à crise no setor calçadista, sobretudo em razão da intensificação da concorrência com a indústria dos países asiáticos, muitas grandes fábricas de calçados foram fechadas e, com a dispensa de mão-de-obra, houve um processo de reorganização da estrutura fabril, protagonizado, em especial, por aqueles que bus...

FDA publishes checklist of Y2K high-risk devices.

Science.gov (United States)

1999-09-01

Key points. The federal Food and Drug Administration (FDA) has developed a list of types of medical devices that have the potential for the most serious consequences for patients should they fail because of Y2K-related problems. This list of computer-controlled potentially high-risk devices can provide a guide to health care facilities regarding the types of devices that should receive priority in their assessment and remediation of medical devices. The list may change as the FDA receives comments on the types of devices included in the list.

High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations

KAUST Repository

Zhang, Chen; Dai, Ying; Johnson, Justin R.; Karvan, Oguz; Koros, William J.

2012-01-01

We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.

High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations

KAUST Repository

Zhang, Chen

2012-02-01

We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.

A Indústria de Defesa, Inovação e Competitividade

OpenAIRE

Fernandes, Vítor Ramon

2007-01-01

O presente artigo pretende contribuir para um melhor conhecimento da indústria de defesa, no sentido de se entender de que forma a inovação e a transferência de tecnologia concorrem para o aumento da competitividade da economia. Após uma análise dos principais desenvolvimentos nesta indústria no pós-Guerra Fria, apresentam-se e analisam-se algumas medidas existentes para o desenvolvimento de uma estratégia para o caso português, que permita beneficiar da inserção...

A inclusão de estudantes indígenas no curso de enfermagem da UFMT – Sinop: alcances e desafios

Directory of Open Access Journals (Sweden)

Botelho, Micnéias Tatiana de Souza Lacerda

2015-05-01

Full Text Available In the scope of the universities, new challenges are placed daily with the aim of overcoming the limitations which hinder the full participation of the subjects. In this sense, the inclusion of indigenous students in higher education represents an iconic and challenging reality. The article discusses how indigenous students and teachers who participate in the undergraduate course in Nursing from the Federal University of Mato Grosso (UFMT in Sinop, Brazil, perceive the Indigenous Inclusion Program (PROIND, introduced there. It is, therefore, an exploratory, descriptive and interpretative study. Four indigenous students and six teachers participated in the study. The data collection was carried out through semi-structured interviews. The perception of the students prioritized the operational and pragmatic aspects, since the political aspects and the critical perception appear only underlying. In their statements, access to higher education was perceived as a federal government initiative, available to the indigenous peoples, and not as a right, an achievement or mitigatory measure. For the teachers, the issue of affirmative policies created certain uneasiness either by not wishing to speak contrary to them, or because they could not find adequate arguments to fight or defend them. The formal entry and the daily presence of the indigenous students in university spaces, when analyzed by more careful lenses, reveal a new form of exclusion, sometimes explicit, sometimes dissimulated, especially in the classroom and spaces of socialization. As will be seen in the text, there is still much to be done and built in order to effectively universalize the offer of quality higher education for indigenous peoples. No âmbito das universidades, novos desafios são postos, cotidianamente, com o intuito de superar as limitações que impedem a participação plena dos sujeitos. Nesse sentido, a inclusão de estudantes indígenas nos cursos superiores caracteriza

Infraestructura y calidad educativa entre los pueblos indígenas originarios sonorenses

Directory of Open Access Journals (Sweden)

José Ángel Vera-Noriega

2016-01-01

Full Text Available El objetivo del artículo se centra en el análisis de la percepción entre los pueblos indígenas originarios de Sonora sobre la infraestructura y calidad educativa para la formación de sus descendientes. Participaron 1.329 personas con un promedio de 50 años de edad y desviación estándar de 16 años, 928 mujeres y 401 hombres. Los resultados indican la prevalencia de una percepción de falta de infraestructura para mejorar la calidad educativa de los niños y jóvenes indígenas. Además, se encontraron diferencias entre los siete pueblos indígenas con respecto a la problemática educativa. Los grupos que mejor están ubicados, en cuanto a acceso educativo, son aquellos que exhiben mayor desplazamiento de su lengua materna.

Dose Matters: FDA's Guidance on Children's X-rays

Science.gov (United States)

... Consumer Updates Dose Matters: FDA's Guidance on Children's X-rays Share Tweet Linkedin Pin it More sharing options ... exposure during medical procedures. The level of ionizing radiation from X-ray imaging is generally very low, but can ...

Socioeconomic status and age at menarche in indigenous and non-indigenous Chilean adolescents Nivel socioeconómico y edad de la menarquia en adolescentes chilenas indígenas y no indígenas

Directory of Open Access Journals (Sweden)

Hugo Amigo

2012-05-01

Full Text Available The objective was to analyze the relationship between socioeconomic status and age at menarche among indigenous and non-indigenous girls in the Araucanía Region of Chile, controlling for nutritional status and mother's age at menarche. A total of 8,624 randomly selected girls from 168 schools were screened, resulting in the selection of 207 indigenous and 200 non-indigenous girls who had recently experienced menarche. Age at menarche was 149.6±10.7 months in the indigenous group and 146.6±10.8 months in the non-indigenous group. Among the non-indigenous, the analysis showed no significant association between age at menarche and socioeconomic status. In the indigenous group, age at menarche among girls with low socioeconomic status was 5.4 months later than among those with higher socioeconomic status. There were no differences in nutritional status according to socioeconomic level. Obesity was associated with earlier menarche. Menarche occurred earlier than in previous generations. An inverse relationship between socioeconomic status and age at menarche was seen in the indigenous group only; low socioeconomic status was associated with delayed menarche, regardless of nutritional status or mother's age at menarche.El objetivo fue analizar la relación entre nivel socioeconómico y edad de menarquia en adolescentes indígenas y no indígenas de la Región de la Araucanía, Chile, controlando el efecto del estado nutricional, y la edad de menarquia de las madres. Se estudiaron 8.624 niñas de 168 escuelas elegidas aleatoriamente, seleccionando 207 indígenas y 200 no indígenas que habían tenido recientemente la menarquia. La edad de menarquia ocurrió a los 149,6±10,7 meses en indígenas y a los 146,6±10,8 meses en no indígenas. En el grupo no indígena, hubo una relación significativa entre edad de menarquia y nivel socioeconómico. En el grupo indígena, edad de menarquia del nivel socioeconómico bajo fue de 5,4 meses más tarde que el

A experiência do professor orientador de estudante indígena em enfermagem La experiencia del profesor orientador del estudiante indígena en enfermería The experience of a faculty mentor to indigenous nursing student

Directory of Open Access Journals (Sweden)

Ivania Vera

2011-01-01

Full Text Available O Programa Permanente de Acompanhamento dos Estudantes Indígenas (PPAEIND visa a atender estudantes indígenas do Estado de Mato Grosso (MT que ingressarem na Universidade Federal de Mato Grosso (UFMT em cursos de Graduação por meio de processo seletivo específico e diferenciado. O programa prevê o Professor Orientador como elo do indígena com a universidade e os alunos não indígenas. Este é um relato de experiência do Professor Orientador no Curso de Enfermagem no Campus de Rondonópolis onde foram preenchidas duas vagas por alunos indígenas em 2007. A experiência para atuar como Professor Orientador teve como desafio a diversidade cultural em relação aos saberes do cuidado. A comunicação terapêutica foi um instrumento efetivo no processo.El Programa Permanente de Acompañamiento de los Estudiantes Indígenas (PPAEIND tiene por objetivo atender a estudiantes indígenas del Estado de Mato Grosso (MT que ingresen a la Universidad Federal de Mato Grosso (UFMT en cursos de Pregrado por medio de un proceso de selección específico y diferenciado. El programa considera al Profesor Orientador como el elo del indígena con la universidad y los alumnos no indígenas. Éste es un relato de experiência del Profesor Orientador en el Curso de Enfermería en el Campus de Rondonópolis donde ocuparon dos vacantes alumnos indígenas en el 2007. La experiencia para actuar como Profesor Orientador tuvo como desafío la diversidad cultural en relación a los saberes del cuidado. La comunicación terapéutica fue un instrumento efectivo en el proceso.The Permanent Program for Monitoring of Indian Students (PPAEIND aims to serve indigenous students in the State of Mato Grosso (MT who join the Federal University of Mato Grosso (UFMT in undergraduate courses, through special and differential selection process. The program provides a Faculty Mentor as a link between the university's indigenous and non-indigenous students. This is an experience

Single Cigarette Sales: State Differences in FDA Advertising and Labeling Violations, 2014, United States.

Science.gov (United States)

Baker, Hannah M; Lee, Joseph G L; Ranney, Leah M; Goldstein, Adam O

2016-02-01

Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335,661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. All 50 states and the District of Columbia. Tobacco retailer inspections conducted by FDA (n = 33 543). State cigarette tax, youth smoking prevalence, poverty, and tobacco production. State proportion of FDA warning letters issued for single cigarette violations. There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A presença feminina nas indústrias de lingerie na cidade de Franca

Directory of Open Access Journals (Sweden)

Mayara C. Freitas Pereira

2008-12-01

Full Text Available Dados recentes nos comprovam que as indústrias de lingerie têm apresentado considerável crescimento na cidade de Franca/SP, cuja história sempre se pautou pela indústria do calçado. Devido à crise no setor calçadista, sobretudo em razão da intensificação da concorrência com a indústria dos países asiáticos, muitas grandes fábricas de calçados foram fechadas e, com a dispensa de mão-de-obra, houve um processo de reorganização da estrutura fabril, protagonizado, em especial, por aqueles que buscavam nova inserção no mercado de trabalho. Diante deste quadro nasce uma nova vocação empresarial comandada basicamente por mulheres, e que está abrindo postos de trabalho para outras mulheres - a indústria de lingerie, que vem crescendo notoriamente. Partimos de um pressuposto inicial de que muitas destas mulheres, hoje à frente da incipiente indústria de lingerie, tiveram alguma experiência pregressa nas indústrias calçadistas, que empregam expressiva mão-de-obra feminina, sobretudo nos setores de apara e corte de couro, pintura e embalagem, sem contar os serviços do terceiro setor em que a presença feminina é, em qualquer circunstância, relevante. Já por estarem num ambiente econômico-industrial relacionado à moda, a transposição do calçado para a lingerie, em que pese as diferenças óbvias, representou para estas mulheres um reajuste em suas antigas qualificações como industriárias do calçado. Este estudo, em andamento, tem como fito levantar dados a respeito do histórico dessa incipiente indústria, e, através do relato dessas mulheres, conhecer suas trajetórias de vida e as experiências que trouxeram para essa nova realidade. Intenta também reconhecer quais foram as estratégias utilizadas para se reorganizarem nos espaços produtivos, que, em alguns casos é a própria casa, além de conhecer e identificar outras experiências que se articulam, no mundo do trabalho.

Agreements and Discrepancies between FDA Reports and Journal Papers on Biologic Agents Approved for Rheumatoid Arthritis

DEFF Research Database (Denmark)

Amarilyo, Gil; Furst, Daniel E; Woo, Jennifer M P

2016-01-01

BACKGROUND: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. OBJECTIVES: This study sought to determine if there are differences between the FDA assessments and journal...... reports on biologic agents developed for the treatment of rheumatoid arthritis. METHODS: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American...... College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report...

Tendencias de Educación Indígena en Latinoamérica.

Directory of Open Access Journals (Sweden)

Teresa Durán Pérez

Full Text Available En esta ponencia se revisan Ias principales corrientes de pensamiento que en los últimos veinte años han ido surgiendo en torna a la educación que, al interior de las sociedades nacionales. deben recibir y protagonizar Ias generaciones jóvenes de los pueblos indígenas de América. Estas corrientes de pensamiento han sido expuestas por estudiosos, mayormente de la cultura y lenguas vernáculas, vinculados de distinto modo al sistema regular de educación, y por dirigentes de organizaciones indígenas.  Explicita o implícitamente estas corrientes incluyen concepciones acerca de los pueblos indígenas: definiciones de sus propias  participaciones  en   el  proceso;  justificaciones   de  las proposiciones  que  exponen; dificultades encontradas en el proceso de aplicar los programas propuestos: evoluciones y proyecciones que este tipo  de educación étnicamente diferenciada supone.

Avaliação da eficiência energética em uma indústria de painéis compensado

OpenAIRE

Silva, Dimas Agostinho da

2013-01-01

Este trabalho trata do perfil e do uso de energia em uma indústria de painéis compensado no Brasil. O seu objetivo geral é corroborar para a melhoria da competitividade da indústria de compensado nacional. Especificamente visou conhecer o perfil do consumo energético na indústria, avaliar possibilidade de ganhos de eficiência no componente energético do processo produtivo e disponibilizar modelos matemáticos de consumo energético aplicado às indústrias de painéis compensado. O trabalho foi de...

Criatividade e inovação empresarial nas indústrias criativas

OpenAIRE

Sousa, Fernando; Nunes, Florbela; Monteiro, Ileana Pardal

2015-01-01

O presente artigo visa demonstrar que a relação de influência entre a atitude dos empresários face à criatividade e as práticas de inovação empresarial é mais forte no setor que envolve as indústrias criativas. Para o efeito foi inquirida uma amostra constituída por 454 empresários, em que 94 pertenciam às indústrias criativas, responsáveis por microempresas e PME portuguesas, através de um inventário de práticas empresariais inovadoras, elaborado a partir do formulário de candidatura à rede ...

Medicare covers the majority of FDA-approved devices and Part B drugs, but restrictions and discrepancies remain.

Science.gov (United States)

Chambers, James D; May, Katherine E; Neumann, Peter J

2013-06-01

The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.

Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.

Science.gov (United States)

Sarapa, Nenad

2007-09-01

The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.

Pueblos indígenas, democracia y representación: los casos de Bolivia y Guatemala

OpenAIRE

Iguanzo, Isabel

2011-01-01

[ES] Este trabajo descriptivo estudia la representación de los intereses de los indígenas en la Cámara Baja en Bolivia (2006) y Guatemala (2008) a través de la distinción de actitudes y comportamiento, entre los que se consideran indígenas y no indígenas. El texto se sostiene en el análisis de las encuestas realizadas por Barómetro de las Américas del Proyecto de Opinión publica de América Latina (LAPOP) y las entrevistas a legisladores del Proyecto Elites Parlamentarias en América Latina. La...

de las mujeres indígenas migrantes

Directory of Open Access Journals (Sweden)

Elizabeth Maier

2006-01-01

falta de tiempo y energía para realizar estos derechos a plenitud, por el otro. El artículo examina la influencia de las nuevas condiciones de vida y trabajo del mercado global en la relación de género y los procesos de sujetivización y ciudadanización de mujeres indígenas inmigrantes.

No sisyphean task: how the FDA can regulate electronic cigarettes.

Science.gov (United States)

Paradise, Jordan

2013-01-01

The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009

Virtual Exploratories

DEFF Research Database (Denmark)

Jensen, Sisse Siggaard

2006-01-01

-systems, the paper introduces the designing strategy referred to as virtual exploratories. Some of the advanced virtual worlds may inspire the design of such provoking and challenging virtual exploratories, and especially the Massively Multi-User Online Role-Playing Games (MMORPGS). However, if we have to learn from...... the design and activity of the advanced virtual worlds and role-playing games, then the empirical research on the actors’ activity, while they are acting, is an important precondition to it. A step towards the conception of such a designing strategy for virtual exploratories is currently pursued....... [1] The research project: Actors and Avatars Communicating in Virtual Worlds – an Empirical Analysis of Actors’ Sense-making Strategies When Based on a Communication Theoretical Approach’ (2006-2007) is supported...

Educação Escolar Indígena - A prática docente dos Guarani Mbya

Directory of Open Access Journals (Sweden)

Janaína Aline dos Santos e Souza

2017-12-01

Full Text Available Este trabalho, vinculado a pesquisa de Mestrado em andamento, propõe o seguinte problema de pesquisa: o que o professorado indígena Guarani Mbya entende ser sua prática docente? Parte-se do pressuposto de que a educação escolar indígena, mais precisamente a partir de 1970, começa a ser ressignificada pelos próprios movimentos e organizações indígenas – reestruturando uma instituição tipicamente não-indígena, norteada até então por princípios de catequização, civilização, integração e preservação –, e que sua reconstrução junto aos projetos de futuro de cada etnia se constitui potencialmente como inovação educacional, superando seu caráter colonialista. Esta pesquisa pretende verificar se a visão que os professores e professoras indígenas têm de suas práticas se fundamenta ou não no modo de transmissão dos saberes tradicionais de sua cultura. No primeiro caso, tais práticas estariam inscritas na luta por reconhecimento e seriam adaptadas à atividade escolar. No entanto, as práticas docentes podem também ser mera reprodução do modelo de ensino escolar predominante, originalmente não-indígena, ainda que se trate oficialmente de uma escola diferenciada. Para examinar essas alternativas, vêm sendo realizadas entrevistas e observação direta na Escola Estadual IndígenaGwyra Pepo, localizada na região de Parelheiros, no município de São Paulo. As informações recolhidas serão analisadas por meio das bases teóricas das pesquisas antropológicas sobre os Guarani e sociológicas sobre inovação educacional, bem como pelo recurso às produções da etnologia ameríndia a respeito da educação escolar indígena

Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men

OpenAIRE

Underhill, Kristen; Morrow, Kathleen M.; Operario, Don; Mayer, Kenneth H.

2014-01-01

The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while o...

Reglamentos indígenas en áreas protegidas de Bolivia: el caso del Pilón Lajas

Directory of Open Access Journals (Sweden)

José Francisco Márquez Guerra

2016-01-01

Full Text Available Durante los últimos años, los enfoques de planificación ecorregional de los programas de conservación han jugado un papel destacado en la configuración y gestión de los territorios indígenas en superposición o colindancia con las Áreas Protegidas en la Amazonía boliviana. Esto se evidencia en el apoyo técnico, jurídico y financiero brindado por las grandes ONG a los procesos participativos para la concepción, implementación y aplicación de instrumentos de gestión territorial y de recursos naturales indígenas como los estatutos y reglamentos comunitarios, entre otros. A partir de un trabajo etnográfico sobre las comunidades de la Reserva de Biosfera y Tierra Comunitaria de Origen Pilón Lajas, este texto describe cómo, en medio de estos procesos de juridificación de las instituciones indígenas, los actores de la conservación pretenden contribuir a la compatibilidad entre los estatutos y reglamentos indígenas y los instrumentos de gestión del Área Protegida. Encontramos que en esta operación de traducción de los objetivos de la conservación a la realidad local se movilizan dos conceptos de legitimación atribuidos a la condición indígena: la ancestralidad y la territorialidad. Los resultados muestran que con la utilización del primero, los actores de la conservación recrean una identidad ecológica para los indígenas, mientras que con el segundo recrean un espacio indígena con vocación de conservación. Se discute si los instrumentos resultantes de la compatibilización toman en cuenta la cosmología y el modo de existencia indígena en relación con los seres no humanos y el espacio.

Violência e apagamento da voz indígena no Brasil - O caso Yanomami

Directory of Open Access Journals (Sweden)

Priscila Maria de Barros Borges

2016-03-01

Full Text Available O presente texto apresenta discussão sobre a lacuna na História Oficial brasileira que corresponde à voz indígena, ainda hoje silenciada. Pretende demonstrar que este silenciamento foi/é construído através de violências de várias ordens ao longo da constituição de nossa historiografia. Na atualidade as diversas minorias têm promovido um movimento de contar sua própria versão da História, através da publicação de livros e produção de documentários. Entre os povos indígenas não é diferente, exemplo disso é o livro A queda do céu, assinado pelo xamã e líder yanomami Davi Kopenawa em parceria com o antropólogo Bruce Albert. A obra A queda do céu, é aqui brevemente interpretada à luz dos conceitos de memória e testemunho, dando destaque à necessidade de que a voz indígena seja disseminada e ouvida, principalmente entre a sociedade não-indígena.

Los derechos culturales con especial referencia a la cosmovisión de los indígenas Bribris de Talamanca

OpenAIRE

Vargas Urbina, Lilliam Marbelli

2014-01-01

En los territorios indígenas de Costa Rica existen ocho grupos socioculturales indígenas distintos: Bribris, Cabécares, Ngäbe, Térrabas, Borucas, Huetares, Malekus y Chorotegas, que habitan en 24 territorios y hablan en 6 idiomas indígenas. La mayoría viven en las áreas rurales o periféricas a los territorios, principalmente en las provincias de Puntarenas y Limón. Directamente en el cantón de Talamanca de esta última provincia vive el 60% de la población indígena del país y su localiza...

Migraciones indígenas a las ciudades de México y Tijuana

OpenAIRE

Velasco Ortiz, Laura

2007-01-01

Este artículo revisa la literatura sobre la migración de poblaciones indígenas a las ciudades de México y Tijuana durante la segunda mitad del siglo XX, con objeto de sistematizar los supuestos y hallazgos de investigaciones realizadas en torno al proceso de integración de los indígenas al medio urbano. El primer apartado presenta la revisión de la literatura sobre la Ciudad de México y algunos trabajos importantes sobre otras ciudades como Oaxaca y Guadalajara, todo lo cual se organiza en fo...

Cultura indígina e identidade nacional

Directory of Open Access Journals (Sweden)

Maria Vitória Silva Paiva

2016-12-01

Full Text Available A ideia de uma identidade nacional foi sendo construída; não havia, inicialmente, um Brasil como hoje conhecemos. Essa noção começa a se solidificar entre os anos de 1940 a 1950. As pessoas se identificavam pelo local onde nasciam, onde sua família estava enraizada, não pela sua nacionalidade. A história do país foi e é construída por um processo contínuo de inclusão-exclusão, o que faz com que diferentes grupos sociais e identitários continuem num processo de busca pela sua afirmação, em especial os indígenas e a população afro-brasileira. A metodologia utilizada na construção deste artigo foi a pesquisa bibliográfica e a pesquisa de campo, tanto atuando como psicóloga no grupo de saúde mental que existe dentro da aldeia Jaraguá, em São Paulo, como nas visitas às aldeias Guarani de Paraty, Rio de Janeiro, e entrevistas com três indígenas, das etnias Guarani, Pitaguary e Tibiriça.

Customizable orthopaedic oncology implants: one institution's experience with meeting current IRB and FDA requirements.

Science.gov (United States)

Willis, Alexander R; Ippolito, Joseph A; Patterson, Francis R; Benevenia, Joseph; Beebe, Kathleen S

2016-01-01

Customizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems. Currently, obtaining customizable orthopaedic implants for orthopaedic oncology patients can be an arduous task involving submitting approval requests to the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). There is great potential for the delay of a patient's surgery and unnecessary paperwork if the submission pathways are misunderstood or a streamlined protocol is not in place. The objective of this study was to review the existing FDA custom implant approval pathways and to determine whether this process was improved with an institutional protocol. An institutional protocol for obtaining IRB and FDA approval for customizable orthopaedic implants was established with the IRB at our institution in 2013. This protocol was approved by the IRB, such that new patients only require submission of a modification to the existing protocol with individualized patient information. During the two-year period of 2013-2014, eight patients were retrospectively identified as having required customizable implants for various orthopaedic oncology surgeries. The dates of request for IRB approval, request for FDA approval, and total time to surgery were recorded, along with the specific pathway utilized for FDA approval. The average patient age was 12 years old (7-21 years old). The average time to IRB approval of a modification to the pre-approved protocol was 14 days (7-21 days). Average time to FDA approval after submission of the IRB approval to the manufacturer was 12.5 days (7-19 days). FDA approval was obtained for all implants as compassionate use requests in accordance with Section 561 of the Federal Food Drug and Cosmetic Act's expanded access provisions. Establishment of an institutional protocol with pre-approval by the IRB can expedite the otherwise time-consuming and complicated

Estado nutricional del hierro en niños de comunidades indígenas de Cali, Colombia

OpenAIRE

Bolaños-Gallardo, María Victoria; Flórez Echeverry, Ofelia; Bermúdez Escobar, Amparo; Hernández Sampayo, Luzmila; Salcedo-Cifuentes, Mercedes

2014-01-01

Introducción: Los escolares son susceptibles a padecer anemia y deficiencia de micronutrientes. No hay reportes del estado del hierro en indígenas del sector urbano. Objetivo: Establecer el estado del hierro en niños de 5 a 14 años de edad de seis comunidades indígenas residentes en la ciudad de Cali-Colombia. Sujetos y métodos: Se estudiaron 62 niños indígenas de 5 a 14 años de edad, sin antecedentes febriles. Se les midió hemoglobina, hematocrito, volumen corpuscular medio, ferritina y tran...

Gobernabilidad y pobreza: proyectos productivos para mujeres indígenas mazahuas del Estado de México

OpenAIRE

Siboney Pineda Ruiz

2006-01-01

Bajo el enfoque de gobernabilidad, este estudio es el resultado de una investigación sobre el sitio que ocupan las mujeres indígenas en las políticas públicas de desarrollo. Al menos en los discursos, las mujeres indígenas son imprescindible en las políticas de combate a la pobreza, tanto en el ámbito internacional como en las políticas sociales, nacionales y estatales en México. Esta investigación realizada en la región central de México donde habita el grupo indígena mazahua, muestra que la...

Intermedicalidade e protagonismo: a atuação dos agentes indígenas de saúde Munduruku da Terra Indígena Kwatá-Laranjal, Amazonas, Brasil

Directory of Open Access Journals (Sweden)

Daniel Scopel

2015-12-01

Full Text Available Resumo O artigo sintetiza resultados de pesquisa etnográfica sobre a atuação dos agentes indígenas de saúde (AIS na Terra Indígena (TI Kwatá-Laranjal, Município de Borba, Amazonas, Brasil. Visa a contribuir para a compreensão do papel dos AIS frente à expansão do modelo médico hegemônico em contexto de pluralidade médica. A análise inclui dados de observação participante e entrevistas realizadas de 2009 a 2011. Entrevistas semiestruturadas foram realizadas com objetivo de registrar narrativas sobre a rotina, experiências e dificuldades no trabalho. Concluímos que a atuação dos AIS é essencial para a atenção primária, e seu papel transcende atividades estritamente técnicas. O AIS Munduruku ocupa posição central na articulação entre saberes indígenas e biomédicos em contextos de intermedicalidade e emerge como um novo ator político em contextos interétnicos.

Changes in the utilization of osteoporosis drugs after the 2010 FDA bisphosphonate drug safety communication

Directory of Open Access Journals (Sweden)

Bander Balkhi

2018-02-01

Conclusions: The 2010 FDA bisphosphonates safety communication appeared to have influenced Osteoporosis utilization in Medicaid recipients. The 2010 FDA bisphosphonates safety communication was associated with a significant reduction in the utilization of bisphosphonates in the Medicaid program.

Evaluation of radiation doses from radioactive drugs

International Nuclear Information System (INIS)

Halperin, J.A.; Grove, G.R.

1977-01-01

Radioactive new drugs are regulated by the Food and Drug Administration (FDA) in the United States. Before a new drug can be marketed it must have an approved New Drug Application (NDA). Clinical investigations of a radioactive new drug are carried out under a Notice of Claimed Investigational Exemption for a New Drug (IND), submitted to the FDA. In the review of the IND, radiation doses are projected on the basis of experimental data from animal models and from calculations based upon radiation characteristics, predicted biodistribution of the drug in humans, and activity to be administered. FDA physicians review anticipated doses and prevent clinical investigations in humans when the potential risk of the use of a radioactive substance outweighs the prospect of achieving beneficial results from the administration of the drug. In the evaluation of an NDA, FDA staff attempt to assure that the intended diagnostic or therapeutic effect is achievable with the lowest practicable radiation dose. Radiation doses from radioactive new drugs are evaluated by physicians within the FDA. Important radioactive new drugs are also evaluated by the Radiopharmaceuticals Advisory Committee. FDA also supports the Center for Internal Radiation Dosimetry at Oak Ridge, to provide information regarding in vivo distribution and dosimetry to critical organs and the whole body from radioactive new drugs. The process for evaluation of radiation doses from radioactive new drugs for protection against use of unnecessary radiation exposure by patients in nuclear medicine procedures, a

76 FR 46303 - Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug...

Science.gov (United States)

2011-08-02

... in an IND. In addition, organizational and editorial revisions were made to improve clarity. The...). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights...

Price, performance, and the FDA approval process: the example of home HIV testing.

Science.gov (United States)

Paltiel, A David; Pollack, Harold A

2010-01-01

The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test's performance. It has asked the manufacturer to conduct field studies of the test's sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test- measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it-depends critically on the manufacturer's retail price. This finding has profound implications for the FDA's approval process.

Los mayas del altiplano: supervivencia indígena en Chiapas y Guatemala

OpenAIRE

Lovell, W. George

2002-01-01

En el contexto americano, pocos grupos indígenas han demostrado la capacidad de sobrevivir a lo largo de la historia como los mayas del altiplano. Hoy día en Chiapas existen más de un millón de indígenas mayas, un número que asciende a cinco o seis millones en el caso de Guatemala. Los pueblos mayas han respondido a la invasión y a la dominación para conservar elementos importantes de su cultura. Este artículo discute las formas en que los mayas del altiplano se han adaptado para sobrevivir a...

Regulating (for the benefit of) future persons: a different perspective on the FDA's jurisdiction to regulate human reproductive cloning.

Science.gov (United States)

Javitt, Gail H; Hudson, Kathy

2003-01-01

The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning. This Article argues, that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born. This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.

Çocuk Diş Hekimliğinde Oral ve İntranazal Yollarla Orta Dereceli Sedasyon

NARCIS (Netherlands)

Özen, B.

2013-01-01

Çocuk Diş Hekimliğinde Oral ve İntranazal Yollarla Orta Dereceli Sedasyon Çocuk diş hekimliğinde korkulu, kaygılı ve uyumsuz hastaların tedavileri, midazolam gibi spesifik ilaçların oral veya intranazal yolla kullanılmıyla, sedasyon yönergelerine uyan hekimler tarafından orta dereceli sedasyon

¿Indígenas o campesinos , pueblos de la selva o de la montaña? Viejos debates, nuevas perspectivas

Directory of Open Access Journals (Sweden)

Christian Gros

2013-01-01

Full Text Available Este artículo interroga en qué medida la creación de una etnicidad genérica, producida por las movilizaciones indígenas durante las tres últimas décadas, permite superar la ruptura tradicional que existe entre pueblos indígenas de las tierras bajas y las comunidades indígenas campesinas de los Andes.

21 CFR 5.1110 - FDA public information offices.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...) Press Relations Staff. Press offices are located in White Oak Bldg. 1, 10903 New Hampshire Ave., Silver...

Inde | Page 74 | CRDI - Centre de recherches pour le ...

International Development Research Centre (IDRC) Digital Library (Canada)

Inde. S'il se peut bien que les changements climatiques viennent aggraver le problème, il ressort de recherches menées dans deux bassins versants du sud du pays que la pollution industrielle, l'exploitation non réglementée des ressources et ...

Lenguas y participación comunitaria en la educación indígena en México

OpenAIRE

Bruno Baronnet

2013-01-01

Este artículo aporta elementos de análisis antropológico para el estudio de las estrategias de los pueblos indígenas ante la enseñanza de las lenguas originarias en la escuela primaria en México. Se enfatiza el contraste entre un contexto multiétnico en el cual predomina una incidencia relativamente débil de las autoridades y las familias indígenas en la gestión administrativa y curricular, como en las colonias que cuentan con nuevas escuelas de educación indígena en Morelos, y otro c...

Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.

Science.gov (United States)

Caliendo, Angela M; Hanson, Kimberly E

2016-04-01

Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

One and done: Reasons principal investigators conduct only one FDA-regulated drug trial

Directory of Open Access Journals (Sweden)

Amy Corneli, PhD, MPH

2017-06-01

Full Text Available Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principal investigators' (PIs decisions to conduct only a single FDA-regulated drug trial. Of the 201 PIs who responded, 54.2% were classified as “one-and-done.” Among these investigators, 28.9% decided for personal reasons to not conduct another trial, and 44.4% were interested in conducting another trial, but no opportunities were available. Three categories of broad barriers were identified as generally burdensome or challenging by the majority of investigators: 1 workload balance (balancing trial implementation with other work obligations and opportunities (63.8%; 2 time requirements (time to initiate and implement trial; investigator and staff time (63.4%; and 3 data and safety reporting (56.5%. Additionally, 46.0% of investigators reported being generally unsatisfied with finance-related issues. These same top three barriers also affected investigators' decisions to no longer conduct FDA-regulated trials. Our findings illuminate three key aspects of investigator turnover. First, they confirm that investigator turnover occurs, as more than half of respondents were truly “one-and-done.” Second, because a large proportion of respondents wanted to conduct more FDA-regulated trials but lacked opportunities to do so, mechanisms that match interested investigators with research sponsors are needed. Third, by focusing on the barriers we identified that affected investigators' decisions to no longer conduct FDA-regulated trials, future efforts to reduce investigator turnover can target issues that matter the most to investigators.

Territorio y Poder: La reivindicación territorial de los indígenas de la amazonia boliviana

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Gabriela Canedo Vásquez

2011-07-01

Full Text Available El artículo pretende mostrar la centralidad que tiene el territorio y la demanda territorial para los grupos indígenas de la amazonia boliviana. El territorio tiene un papel importante en la reproducción cultural y en la organización política. La investigación se llevó a cabo en la provincia Mojos del departamento del Beni, y muestra que el manejo territorial itinerante y la percepción del territorio que tenían los grupos indígenas se ha transformado a partir del marco estatal –concretamente desde la ley INRA–. Hoy en día los indígenas demandan títulos de propiedad de los espacios ocupados, ante el avasallamiento de los blancos/karayanas. Es así que aquella concepción ilimitada del territorio, propio de los pueblos panindios, se ha transformado, pues en la actualidad los indígenas perciben un territorio limitado, cercado por propiedades privadas. Sin embargo, el territorio al convertirse en una de las demandas centrales de la organización indígena, es el elemento que les permite posicionarse políticamente en un escenario local y nacional.

Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.

Science.gov (United States)

Deyo, Richard A

2004-01-01

Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.

En busca de tinterrillos. Intermediarios en el mundo indígena ecuatoriano durante el siglo XX

Directory of Open Access Journals (Sweden)

Marc Becker

2013-07-01

Full Text Available Este artículo aborda el papel de los abogados semiprofesionales, conocidos como tinterillos, en las comunidades indígenas de la sierra ecuatoriana, a partir de mediados del siglo XIX, quienes adquirieron una presencia aparentemente ubicua en las comunidades rurales del Ecuador. Muchas veces los tinterillos fueron parte de las elites locales con algo de educación. Inspiraban respeto entre los indígenas (quienes en su mayoría eran analfabetos debido a su habilidad de manejar documentos escritos. Estos intermediarios comúnmente explotaron su posición privilegiada para beneficio propio económico, social y político. Sin embargo, los indígenas llegaron a depender del apoyo de los tinterillos para denunciar ante el gobierno los abusos de los terratenientes. En ocasiones, en lugar de sentirse impotentes o víctimas, los indígenas aprendieron a negociar su relaciones con esos intermediarios para su beneficio. El estudio de los tinterillos permite examinar las relaciones de poder que se negociaron entre diferentes culturas y a través de profundas divisiones de clase.

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

Science.gov (United States)

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

We really need to talk: adapting FDA processes to rapid change.

Science.gov (United States)

Lykken, Sara

2013-01-01

The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system.

THPdb: Database of FDA-approved peptide and protein therapeutics.

Directory of Open Access Journals (Sweden)

Salman Sadullah Usmani

Full Text Available THPdb (http://crdd.osdd.net/raghava/thpdb/ is a manually curated repository of Food and Drug Administration (FDA approved therapeutic peptides and proteins. The information in THPdb has been compiled from 985 research publications, 70 patents and other resources like DrugBank. The current version of the database holds a total of 852 entries, providing comprehensive information on 239 US-FDA approved therapeutic peptides and proteins and their 380 drug variants. The information on each peptide and protein includes their sequences, chemical properties, composition, disease area, mode of activity, physical appearance, category or pharmacological class, pharmacodynamics, route of administration, toxicity, target of activity, etc. In addition, we have annotated the structure of most of the protein and peptides. A number of user-friendly tools have been integrated to facilitate easy browsing and data analysis. To assist scientific community, a web interface and mobile App have also been developed.

El título indígena y su aplicabilidad en el Derecho chileno

Directory of Open Access Journals (Sweden)

Gonzalo Aguilar Cavallo

2005-01-01

Full Text Available En las últimas décadas, una de las reivindicaciones más poderosas de los pueblos indígenas ha sido el reconocimiento de los derechos a la tierra. Los pueblos indígenas consideran que tienen un título inmemorial a usar y poseer las tierras que ellos ocupan o han ocupado tradicionalmente. Ellos encuentran en su Derecho propio el mejor argumento para defender esta reivindicación. El título indígena a poseer sus tierras ha sido aceptado en forma creciente por los tribunales, tanto extranjeros como internacionales, lo cual constituye un reconocimiento notable de los derechos indígenas. Tanto los casos internacionales como del derecho comparado podrían inspirar las decisiones de nuestros tribunales en esta materia.One of the most powerful indigenous peoples' claims over the last decades has been the recognition of land rights. Indigenous peoples consider that they have an immemorial entitlement to use and possess the lands they occupy or have traditionally occupied. They find in their own law the best argument to support this claim. Such an entitlement to possess and own lands has increasingly been accepted by foreign and international courts, which constitute a noteworthy recognition of indigenous rights. International and comparative case law might inspire judgments of our national courts about this matter.

Inde | Page 74 | CRDI - Centre de recherches pour le ...

International Development Research Centre (IDRC) Digital Library (Canada)

In just two days, 12 million people in India's coastal states of Odisha and Andhra Pradesh suffered massive losses, of their homes and livelihoods, when Cyclone Phailin ... Une urbanisation rapide sollicite fortement les ressources en eau limitées de l'Inde. ... Rapid urbanization is squeezing India's limited water resources.

Usefulness of [18F]-DA and [18F]-DOPA for PET imaging in a mouse model of pheochromocytoma

International Nuclear Information System (INIS)

Martiniova, Lucia; Cleary, Susannah; Lai, Edwin W.; Kiesewetter, Dale O.; Seidel, Jurgen; Dawson, Linda F.; Phillips, Jacqueline K.; Thomasson, David; Chen Xiaoyuan; Eisenhofer, Graeme; Powers, James F.; Kvetnansky, Richard

2012-01-01

Purpose: To evaluate the usefulness of [ 18 F]-6-fluorodopamine ([ 18 F]-DA) and [ 18 F]-L-6-fluoro-3,4-dihydroxyphenylalanine ([ 18 F]-DOPA) positron emission tomography (PET) in the detection of subcutaneous (s.c.) and metastatic pheochromocytoma in mice; to assess the expression of the norepinephrine transporter (NET) and vesicular monoamine transporters 1 and 2 (VMAT1 and VMAT2), all important for [ 18 F]-DA and [ 18 F]-DOPA uptake. Furthermore, to compare tumor detection by micro-computed tomography (microCT) to magnetic resonance imaging (MRI) in individual mouse. Methods: SUV max values were calculated from [ 18 F]-DA and [ 18 F]-DOPA PET, tumor-to-liver ratios (TLR) were obtained and expression of NET, VMAT1 and VMAT2 was evaluated. Results: [ 18 F]-DA detected less metastatic lesions compared to [ 18 F]-DOPA. TLR values for liver metastases were 2.26–2.71 for [ 18 F]-DOPA and 1.83–2.83 for [ 18 F]-DA. A limited uptake of [ 18 F]-DA was found in s.c. tumors (TLR=0.22-0.27) compared to [ 18 F]-DOPA (TLR=1.56-2.24). Overall, NET and VMAT2 were expressed in all organ and s.c. tumors. However, s.c. tumors lacked expression of VMAT1. We confirmed [ 18 F]-DA's high affinity for the NET for its uptake and VMAT1 and VMAT2 for its storage and retention in pheochromocytoma cell vesicles. In contrast, [ 18 F]-DOPA was found to utilize only VMAT2. Conclusion: MRI was superior in the detection of all organ tumors compared to microCT and PET. [ 18 F]-DOPA had overall better sensitivity than [ 18 F]-DA for the detection of metastases. Subcutaneous tumors were localized only with [ 18 F]-DOPA, a finding that may reflect differences in expression of VMAT1 and VMAT2, perhaps similar to some patients with pheochromocytoma where [ 18 F]-DOPA provides better visualization of lesions than [ 18 F]-DA.

Los pueblos indígenas y la reforma del Estado en América Latina

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Willem Assies

2002-01-01

Full Text Available El reconocimiento constitucional de los derechos indígenas en América Latina, así como la ratificación del Convenio 169 de la OTI hacen surgir varios interrogantes. En este artículo examinamos algunas cuestiones en debate. Para contextualizar, iniciamos el artículo indicando la imbricación de las luchas indígenas en los procesos de reforma del Estado y de la economía, así como de democratización. Después exploramos las interrogantes acerca del reconocimiento del derecho propio del indígena, de sus “usos y costumbres” políticos y de sus territorios. Concluimos que el reconocimiento de una pluralidad de esferas públicas de distinta configuración es una precondición para la convivencia y el diálogo intercultural.

Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.

Science.gov (United States)

Sage, Adam; Blalock, Susan J; Carpenter, Delesha

This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications. Copyright © 2016 Elsevier Inc. All rights reserved.

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International Development Research Centre (IDRC) Digital Library (Canada)

Langue English. Read more about Approche concertée en matière de lutte contre la violence faite aux femmes du Meghalaya. Langue French. Read more about Donner aux travailleurs du sexe les moyens de consigner les incidents de violence (Inde et Cambodge). Langue French. Read more about Enabling Sex Workers ...

FDA publishes conflict of interest rules for clinical trials. Food and Drug Administration.

Science.gov (United States)

James, J S

1998-03-06

The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.

Indústria do conhecimento: uma poderosa engrenagem Industria del conocimiento: un poderoso engranaje Knowledge industry: a powerful mechanism

OpenAIRE

Vera Regina da Silva Miguelote; Kenneth Rochel de Camargo Jr

2010-01-01

O artigo aborda a articulação da indústria farmacêutica à indústria do conhecimento, por meio de poderosas estratégias de marketing. Com o objetivo de legitimar cientificamente seus produtos, a indústria interfere na produção de conhecimento médico. Configurando uma engrenagem de direcionamento de interesses econômicos, financia pesquisas na área de medicamentos, enviesa seus resultados e incentiva a produção e publicação de artigos científicos. Trata-se de uma engrenagem que ameaça important...

Los movimientos indígenas de Colombia y los problemas del medió-ambiente

OpenAIRE

Espinel Souares, Anastassia

2003-01-01

Presentación La multiculturalidad de la Ciudad de México y los Derechos Indígenas Oehmichen, Cristina Conceptos indígenas de la formación territorial y Etno-Político frente al Estado Republicano-Nacional Fischer, Eva Disputas matrimoniales y cambio social en Coyutla, Veracruz (México) Chenaut, Victoria El debate indio sobre la ciudadanía multicultural en México: La revuelta por la dignidad Valladares de la Cruz, Laura Análisis de las actitudes de políticos criollos ...

La multiculturalidad de la Ciudad de México y los Derechos Indígenas

OpenAIRE

Oehmichen, Cristina

2003-01-01

Presentación La multiculturalidad de la Ciudad de México y los Derechos Indígenas Oehmichen, Cristina Conceptos indígenas de la formación territorial y Etno-Político frente al Estado Republicano-Nacional Fischer, Eva Disputas matrimoniales y cambio social en Coyutla, Veracruz (México) Chenaut, Victoria El debate indio sobre la ciudadanía multicultural en México: La revuelta por la dignidad Valladares de la Cruz, Laura Análisis de las actitudes de políticos criollos ...

En busa de tinterillos. Intermediarios en el mundo indígena ecuatoriano duante el siglo XX

Directory of Open Access Journals (Sweden)

Marc Becker

2013-07-01

Full Text Available Este artículo aborda el papel de los abogados semiprofesionales, conocidos como tinterillos, en las comunidades indígenas de la sierra ecuatoriana, a partir de mediados del siglo XIX, quienes adquirieron una presencia aparentemente ubicua en las comunidades rurales del Ecuador. Muchas veces los tinterillos fueron parte de las élites locales con algo de educación. Inspiraban respeto entre los indígenas (quienes, en su mayoría, eran analfabetos debido a su habilidad a manejar documentos escritos. Estos intermediarios comúnmente explotaron su posición privilegiada para su propio beneficio económico, social y político. Sin embargo, los indígenas llegaron a depender del apoyo de los tinterillos para denunciar ante el gobierno los abusos de los terratenientes. En ocasiones, en lugar de sentirse impotentes o víctimas, los indígenas aprendieron a negociar sus relaciones con esos intermediarios para su beneficio. El estudio de los tinterillos permite examinar las relaciones de poder que se negociaron entre diferentes culturas y a través de profundas divisiones de clase.

Dora Mayer, los indígenas y la nación peruana a inicios del siglo XX

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Zegarra Flórez, Margarita

2009-06-01

Full Text Available This article analyses the expositions that the journalist Dora Mayer did regarding the “indigenous question” and the Peruvian nation, in a stage of deep social conflicts that take place in a context of economic modernization sustained on pre-modern labor relationships and indigenous oppression. We reconstructed her vision on how the relation between the components of the Peruvian Nation had to be, her critics towards indigenous exclusion and her warnings on the repercussions that the latter one had. The main purpose is to think about the impact of the double formation on critical conscience of the public opinion, as well as on civic education of the indigenous people that Dora Mayer did in El Deber Pro- Indígena (1912-1917.

En el artículo se abordan los planteamientos que la periodista Dora Mayer hiciera sobre la “cuestión indígena” y la nación peruana, en una etapa de profundos conflictos sociales surgidos en un entorno de modernización económica sustentada sobre relaciones laborales premodernas y opresión indígena. Reconstruimos su visión sobre cómo debía ser la relación entre los componentes de la nación peruana, sus críticas a la exclusión indígena y sus advertencias sobre las repercusiones disociadoras que ésta última tenía. El propósito central es reflexionar sobre el impacto de la doble labor de formación de conciencia crítica de la opinión pública y de educación cívica de los indígenas, que llevó a cabo Dora Mayer desde El Deber Pro-Indígena (1912-1917.

Percepciones de comportamientos parentales de jóvenes indígenas mexicanos

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Rosario Esteinou Madrid

2013-01-01

Full Text Available El trabajo presenta algunos resultados sobre algunas de las ten- dencias que se muestran hoy en día en torno a los comportamientos paren- tales en el proceso de socialización y de educación de sus hijos adolescentes. La información que se expone procede de una investigación que se realizó sobre la educación parental y la competencia social de los jóvenes en tres estados con alta concentración de población indígena. Para tal efecto, se levantó una encuesta en una muestra de 450 adolescentes indígenas de los estados de Chiapas, Yucatán y Oaxaca. En particular se analizan, a partir de las percepciones de los adolescentes, algunos comportamientos de padres y madres referentes a dos dimensiones: una, relacionada con el apoyo, la pro- tección y la promoción de comportamientos prosociales en los adolescentes; y otra referida a distintas formas en que se ejerce el control (monitoreo, permisividad, rechazo, inducción de culpa, y punitividad. De acuerdo a dichas percepciones, el principal resultado obtenido establece que los com- portamientos de los padres indígenas se asemeja al estilo autoritario.

Fisher, Neyman, and Bayes at FDA.

Science.gov (United States)

Rubin, Donald B

2016-01-01

The wise use of statistical ideas in practice essentially requires some Bayesian thinking, in contrast to the classical rigid frequentist dogma. This dogma too often has seemed to influence the applications of statistics, even at agencies like the FDA. Greg Campbell was one of the most important advocates there for more nuanced modes of thought, especially Bayesian statistics. Because two brilliant statisticians, Ronald Fisher and Jerzy Neyman, are often credited with instilling the traditional frequentist approach in current practice, I argue that both men were actually seeking very Bayesian answers, and neither would have endorsed the rigid application of their ideas.

Three Drugs Approved for Urothelial Carcinoma by FDA.

Science.gov (United States)

2017-07-01

The FDA has approved one PD-1 checkpoint inhibitor, pembrolizumab, and two PD-L1 checkpoint inhibitors, avelumab and durvalumab, to treat metastatic urothelial carcinoma in patients whose disease continues to progress despite platinum-based chemotherapy. This brings the total number of checkpoint inhibitors for the disease to five, prompting questions about how best to use them. ©2017 American Association for Cancer Research.

CRITICAL SUCCESS FACTORS IN THE SOFTWARE INDUSTRY AND THEIR RELATION WITH STRATEGIC BUSINESS ORIENTATION: AN EMPIRICAL-EXPLORATORY STUDY

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Manuel Rodenes Adam

2007-05-01

Full Text Available This article presents the results of an empirical-exploratory study applied to companies of the Software Industry (IndSw sector. One of the objectives pursued was to know the Critical Success Factors (CSF of the SWInd and their relation with the business strategic orientation. The CSF identified and analyzed were: Government Support, Human Capital, Marketing, Quality and Innovation. The research results reveal that it is possible to identify the existence of at least two main groups of strategic orientation (cost and differentiation within this sector. The analysis of the relation between business strategic orientation and the CSF emphasizes the following CSF: Human Capital, Quality and Innovation, the remaining factors present a little significant relation. The empirical study was made through multivariate analysis techniques. The analysis of results is based on data collected through the application of a web survey (Internet to Mexican software companies. The survey was applied in July 2005.

Prevalencia de diabetes mellitus e hiperlipidemias en indígenas otomíes

OpenAIRE

Alvarado-Osuna Claudia; Milian-Suazo Feliciano; Valles-Sánchez Victoria

2001-01-01

Objetivo. Determinar prevalencia y factores de riesgo de la diabetes mellitus (DM) e hiperlipidemias en un grupo de indígenas otomíes de Querétaro. Material y métodos. Entre 1996 y 1997, en muestreo de conveniencia se trabajó con 91 indígenas, de 15 a 77 años de edad, de las comunidades de Yosphí y El Rincón, del estado de Querétaro, México. Se tomaron muestras sanguíneas en ayuno y se determinó la concentración de glucosa, colesterol y triglicéridos. Se realizó análisis estadístico para comp...

La multiculturalidad de la ciudad de México y los derechos indígenas

Directory of Open Access Journals (Sweden)

Cristina Oehmichen

2003-01-01

Full Text Available A partir de 1970 y, sobre todo, de 1990 en adelante, los indígenas de México han ido incorporándose a los flujos migratorios tanto internos como internacionales. Las comunidades se han extendido mucho más allá de los límites de pueblos específicos, pues sus miembros han emigrado y se han establecido en diversos puntos geográficos. A través de las redes que se extienden en el espacio nacional e internacional, los indígenas de México han tendido a reconstituir el vínculo comunitario y a dinamizar las relaciones sociales que los mantienen unidos en los lugares de destino. En este artículo analizo los procesos de construcción de las fronteras étnicas en la ciudad de México, con lo cual busco descubrir una lógica subyacente en la discriminación y lucha por los derechos a la ciudadanía de los indígenas radicados en la capital.

As relações contratuais das indústrias criativas: o caso dos quadrinhos no Ceará

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Paulo César de Sousa Batista

Full Text Available O segmento dos quadrinhos, inserido no contexto das indústrias criativas, tem assumido relevância econômica e cultural. Sendo assim, esta pesquisa tem como objetivo principal analisar fatores importantes do processo de contratação dos profissionais dessa área. O foco será na relação contratual entre os dois principais protagonistas das indústrias criativas, o artista e o agente, sendo que as análises serão baseadas na percepção dos artistas a respeito, principalmente, dos custos de transação, direitos autorais, assimetria de informações e agentes de mercado. O estudo de caráter descritivo e exploratório fez uso de métodos qualitativos também nas entrevistas realizadas no trabalho empírico. Os respondentes fazem parte da indústria criativa cearense e atuam no setor de quadrinhos. Os principais resultados encontrados pela análise de conteúdo das entrevistas diz respeito, basicamente, a falta de profissionalismo ainda existente no setor de quadrinhos da indústria criativa cearense. Há ainda, conforme indícios desta pesquisa, falta de visão mercadológica e de mentalidade profissional dos artistas, ausência de agentes especializados para interferir comercialmente, e a ausência de proteção aos direitos autorais e conexos. Acredita-se que os resultados aqui disponibilizados podem gerar informações relevantes para a melhor compreensão do mercado tido como objeto de estudo, e com isso colaborar na profissionalização deste importante segmento cultural para a atual economia.

Tambos de Filosofía Indígenas: la perspectiva de la nosotridad

Directory of Open Access Journals (Sweden)

Guillermo Meza Salcedo

2017-08-01

Full Text Available La existencia de una filosofía al interior de las culturas ancestrales en América Latina ha sido una cuestión hasta hoy debatida, desde que se planteó la interrogante sobre el filosofar de estos pueblos originarios. La colonización epistemológica de la cultura occidental ha llevado a invisibilizar y/o negar la existencia de otros saberes y formas de vivir la vida de diferentes comunidades indígenas. La filosofía como ejercicio racional para responder a los grandes interrogantes de la vida, no es sólo una, no tiene patria, ni época, sino que son múltiples, multiculturales, y algunas de ellas comunales. Entre los indígenas hay una cosmovivencia y un pensamiento nosótrico que puede mejorar la calidad de vida en todos los ámbitos de la misma, que en esencia son relacionales. Dos tópicos darán la pauta en este trabajo: primero el de las cosmovisiones y filosofías amerindias y en segundo lugar el de la nosotridad entre los incas y mayas-tojolabales. Palabras clave: filosofía indígena, nosotridad, cosmovisión, América Latina. Tambos das filosofias indígena: a perspectiva da nosotridad Resumo A existência de uma filosofia dentro das culturas ancestrais da América Latina tem sido uma questão amplamente discutida até os últimos dias, desde que a questão sobre o filosofar dessas populações aumentou. A colonização epistemológica da cultura ocidental levou à negação da existência de outros meios de conhecimento e formas diferentes de viver a vida nas comunidades indígenas. Filosofia como exercício racional para responder a grandes questões na vida, não é apenas uma, não tem pátria ou tempo, mas são múltiplas, multiculturais e algumas delas são comunais. Entre a população indígena há uma experiência da cosmo -cosmovivencia- e um pensamento nosotrico que podem melhorar a qualidade de vida em todos os aspectos, que em essência são relacionais.. Dois tópicos principais são o ponto de partida deste trabalho

Justicia electoral y enfoque de género en los sistemas normativos indígenas

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Claudia Pastor Badilla

2012-01-01

Full Text Available : Expone los mecanismos para lograr que a través de la justicia electoral, se garantice el acceso de las mujeres indígenas al ejercicio de los derechos político-electorales en condiciones de igualdad con los hombres. En la primera parte señala algunas de las discusiones que se llevaron a cabo en el ámbito doctrinario, y que tienen que ver con nuevos enfoques académicos sobre sociedades en las que conviven grupos culturales diversos. Lo anterior, con el objetivo de demostrar, en un segundo momento, las razones por las que es necesario que esos nuevos enfoques sean asumidos por todos los interesados en que el derecho indígena y los derechos humanos sean compatibles y se ejerzan a un mismo tiempo. Por último, señala las razones por las que ese cambio de perspectiva redundará en beneficio de las mujeres indígenas y de la comunidad de la que forman parte.

Crisis cafetalera y migración interna entre campesinos indígenas, en Huehuetla México

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Alejandro Ortega Hernández

2013-01-01

Full Text Available La migración sigue siendo un fenómeno social presente en México, con diferentes niveles de intensidad. Para conocer este movimiento poblacional en una zona indígena totonaca se realizó un estudio en Huehuetla, Puebla, mediante una muestra estadística a 83 indígenas productores de café. Los resultados indican que entre los campesinos indígenas, la migración interna, proceso actualmente poco estudiado, se encuentra asociada con la crisis de precios que vive la cafeticultura desde hace más de una década. Las ciudades de México y Puebla se son los principales polos de atracción, en los cuales los totonacos encuentran trabajo y mejores ingresos, que los que actualmente la cafeticultura y los espacios rurales no les pueden ofrecer.

El carácter reconstrutivo de la justicia indígena, en Chimborazo: perspectiva ética

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Gerardo Miguel Nieves Loja

2015-08-01

Full Text Available Durante los últimos años en Ecuador, ha comenzado a hablarse de la “justicia indígena”. Los medios de comunicación, en la mayor parte de casos por su desconocimiento, hablaron de “linchamientos” y “ajusticiamientos”, como si se tratara de un acto de salvajismo primitivo que atenta los Derechos Humanos. La resolución de conflictos en la Justicia indígena, tiene instancias y procedimientos que conducen, a la reconstrucción individual y colectiva de la comunidad. Los procedimientos de la justicia indígena, los castigos y los rituales de sanación son reconstructivos, lo que muestra el ir más allá, respecto a la justicia ordinaria de occidente, que termina en la cárcel, o máximo en una experiencia de rehabilitación.

De Chiapas a California. Experiencia migratoria y cambio cultural en jóvenes indígenas

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Tania Cruz Salazar

2016-12-01

Full Text Available Documento, desde una perspectiva etnográfica, la experiencia migratoria internacional de jóvenes indígenas chiapanecos y sus adaptaciones culturales. Sostengo que la participación de la juventud indígena ha sido central para el desarrollo económico del estado, y esto tiene sus orígenes en la tradicional migración indígena interna (siglo xix y nacional (siglo xx protagonizada en su tiempo por quienes hoy son los abuelos o padres. Para las actuales generaciones, la migración internacional, aunque aún es una estrategia económica, ya no es temporal como lo fue al inicio, por lo que su estadía en los Estados Unidos les implica cambios a nivel subjetivo, comunitario y cultural. Es en estos panoramas que analizo aquello que cambia y permanece.

Right to experimental treatment: FDA new drug approval, constitutional rights, and the public's health.

Science.gov (United States)

Leonard, Elizabeth Weeks

2009-01-01

On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.

FDA: polyurethane condom carries "extremely misleading" label. Federal agency allows distribution for public health's sake.

Science.gov (United States)

1995-02-01

The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.

La transformation économique de l'Inde favorise-t-elle l ...

International Development Research Centre (IDRC) Digital Library (Canada)

La transformation économique de l'Inde favorise-t-elle l'autonomisation ... sur les plans social et économique, il peut arriver que la participation des femmes à la vie ... Related content. Call for proposals for three Asian market-entry studies.

Inde | Page 77 | CRDI - Centre de recherches pour le ...

International Development Research Centre (IDRC) Digital Library (Canada)

Ce n'est un secret pour personne que les produits agricoles traditionnels comme les mils et les légumineuses à graines sont très nutritifs. C'est pourquoi des chercheurs collaborent actuellement avec des femmes en Inde et en Éthiopie pour faciliter l'utilisation à des fins personnelles (pour la préparation de repas sains) et ...

Ativismo Homossexual Indígena: Uma Análise Comparativa entre Brasil e América do Norte

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Estevão Rafael Fernandes

2015-03-01

Full Text Available A partir da comparação entre Brasil e América do Norte (principalmente Estados Unidos, mas também, em menor medida, Canadá este artigo busca compreender a formação e a mobilização do ativismo homossexual indígena nesses dois contextos. O presente trabalho baseou-se em levantamento bibliográfico, entrevistas e trabalho de campo desenvolvido entre junho de 2012 e agosto de 2014. Ao longo do texto será apresentado o percurso recente que levou os Estados Unidos à consolidação do movimento two-spirit, em contraposição à invisibilidade do tema no Brasil. Conclui-se isso se deveu a um conjunto de fatores que fizeram com que os movimentos homossexuais indígenas nos Estados Unidos criassem uma identidade pan-indígena na qual a homossexualidade figura como discurso tradicionalista, religioso e anticolonial, enquanto no Brasil ocorreu o oposto, já que a homossexualidade indígena é vista como “perda” cultural.

Una universidad “de” y “para” el movimiento indígena (A university of and for the indigenous movement)

OpenAIRE

González Terreros, María Isabel; Aguilera Morales, Alcira

2016-01-01

El presente artículo analiza los aportes políticos y pedagógicos de la Universidad Autónoma Intercultural Indígena del Cauca –UAIIN-, que es una propuesta educativa de y para los pueblos indígenas en Colombia. La Universidad se ha constituido en una alternativa para el fortalecimiento de los conocimientos ancestrales al gestarse como parte de las reivindicaciones y luchas del movimiento indígena que propone la Universidad como opción de formación para sus comunidades. La Universidad ret...

La educación indígena en proceso: Sujeto, escuela y autonomía en el Cauca, Colombia

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Jhon Jairo Angarita-Ossa

2015-01-01

Full Text Available El artículo presenta los resultados de la investigación sobre el proceso de constitución del Sistema de Educación Indígena Propio (SEIP en el departamento del Cauca, Colombia. Este abordaje da cuenta de la identificación del sujeto indígena, subordinado en un orden social hegemónico, en el contexto de la educación moderna bajo la influencia neoliberal. Se propone reconocer la presencia de un modelo edu - cativo tradicional, propuesto a los indígenas y la consecuente construcción de una propuesta alternativa de educación propia, construida al interior de sus comunidades. No obstante, se evidencia una serie de conflictos emergentes en el proceso de apropiación de la escuela, a partir del alcance de mayores niveles de autonomía educativa, por parte de las comunidades indígenas, en detrimento del poder de agentes hegemónicos tradicionales; dado el interés social, cultural y político de este escenario. En consecuencia, se expone la configuración del proyecto de autonomía y gobierno del territorio, en el ámbito educativo, teniendo como protagonista al sujeto indígena y a los alcances de una serie sucesiva de conquistas en la gestión del sistema educativo, que se materializa en clave de hegemonía alternativa. Finalmente, se concluye que el reconocimiento del sujeto indígena propone un giro cultural y político sustentado en el sistema educativo propio, aspecto que apunta a la constitución de una hegemonía alternativa, sólo posible desde mayores niveles de control de la educación, en perspectiva de la consolidación de una educación propia e intercultural del movimiento indígena en el departamento del Cauca, Colombia.

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

Science.gov (United States)

Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

2013-01-22

The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5�

76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

Science.gov (United States)

2011-10-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands

NARCIS (Netherlands)

Bastiaans, D.E.T.; Forcat, S.; Lyall, H.; Cressey, T.R.; Hansudewechakul, R.; Kanjanavanit, S.; Noguera-Julian, A.; Konigs, C.; Inshaw, J.R.; Chalermpantmetagul, S.; Saidi, Y.; Compagnucci, A.; Harper, L.M.; Giaquinto, C.; Colbers, A.P.; Burger, D.M.

2014-01-01

BACKGROUND: Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or body surface area under FDA approval

[Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].

Science.gov (United States)

Huang, Fanghua

2010-04-01

Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine.

MedWatch, the FDA Safety Information and Adverse Event Reporting Program

Science.gov (United States)

... Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it ... approved information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety ...

El anciano en las comunidades indígenas Páez y Zenú

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Canencio Benavides Doris

1996-06-01

Full Text Available

Son muchos los pueblos indígenas existentes en Colombia, entre ellos encontramos a los zenues y a los paeces. Los primeros se encuentran localizados al noreste de Córdoba; los paeces están ubicados en diferentes lugares del departamento del Cauca. En estas dos comunidades indígenas existen algunas diferencias dadas no solo por su ubicación geográfica, sino por aspectos organizacionales e históricos. Pero no se puede desconocer las similitudes que existen entre ellas como es el concepto del anciano dentro de la comunidad, su rol en la familia y el respeto que se le tiene como transmisor de valores y creencias.

Comparison of the FDA and ASCO/CAP Criteria for HER2 Immunohistochemistry in Upper Urinary Tract Urothelial Carcinoma

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Gilhyang Kim

2016-11-01

Full Text Available Background Human epidermal growth factor receptor 2 (HER2 is one of the known oncogenes in urothelial carcinoma. However, the association between HER2 and the prognosis of upper urinary tract urothelial carcinoma (UUTUC has not yet been fully clarified. The aim of this study was to evaluate HER2 expression using the United States Food and Drug Administration (FDA criteria and American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP criteria and compare their prognostic significance in UUTUC. Methods HER2 expression was evaluated in 144 cases of UUTUC by immunohistochemistry (IHC using tissue microarrays. We separately analyzed HER2 expression using the FDA and ASCO/CAP criteria. The IHC results were categorized into low (0, 1+ and high (2+, 3+ groups. Results Using the FDA criteria, 94 cases were negative, 38 cases were 1+, nine cases were 2+, and three cases were 3+. Using the ASCO/CAP criteria, 94 cases were negative, 34 cases were 1+, 13 cases were 2+, and three cases were 3+. Four cases showing 2+ according to the ASCO/CAP criteria were reclassified as 1+ by the FDA criteria. High HER2 expression by both the FDA criteria and ASCO/CAP criteria was significantly associated with International Society of Urological Pathology high grade (p = .001 and p < .001. The high HER2 expression group classified with the FDA criteria showed significantly shorter cancer-specific survival (p = .004, but the HER2 high and low expression groups classified with the ASCO/CAP criteria did not show significant differences (p = .161 in cancer-specific survival. Conclusions HER2 high expression groups were significantly associated with shorter cancer-specific survival, and our study revealed that the FDA criteria are more suitable for determining HER2 expression in UUTUC.

Mira – Artes Visuais Contemporâneas dos Povos Indígenas: Introdução

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María Inês de Almeida

2014-09-01

Full Text Available O projeto Mira! Artes Visuais Contemporâneas dos Povos Indígenas nasceu com o intuito de trazer as muitas visões de mundo dos povos originários da imensa região pan-amazônica. O projeto Mira! com a exposição de 125 obras de artistas indígenas (pinturas, esculturas, arte digital quer mostrar ao público que, ao lado de estéticas ligadas ao mundo ocidental, há aquelas que se depuram em outros ambientes. Cinquenta e quatro artistas indígenas de Brasil, Bolívia, Colômbia, Equador e Peru estão participando da exposição Mira! Alguns artistas foram convidados a expor seus pensamentos e a debater sobre suas visões no seminário ocorrido em Belo Horizonte, em junho de 2013, quando a Mira! foi inaugurada.

Estado nutricional y aspectos alimentarios de mujeres indígenas del departamento de Presidente Hayes, Paraguay

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Gloria Echagüe

2015-12-01

Full Text Available Introducción: Las comunidades indígenas presentan un mayor riesgo de inseguridad alimentaria y malnutrición, menor disponibilidad de recursos, y una creciente dependencia de alimentos más baratos aunque con un alto grado de procesamiento. Objetivo: Identificar el estado nutricional y aspectos alimentarios en mujeres indígenas de tres comunidades del Departamento de Presidente Hayes, Chaco Paraguayo. Metodología: Estudio observacional de diseño transversal con componente analítico, que incluyó a 81 mujeres de 15 a 44 años de edad, de las etnias Maká y Toba Qom. Previo consentimiento informado, se realizó la valoración nutricional y la entrevista para obtener los datos sociodemográficos y alimentarios. Resultados: Las mujeres indígenas presentaron una frecuencia de sobrepeso de 30,8% y obesidad del 21,0%, mientras que el 1,2 % presentó desnutrición. No encontramos diferencia significativa entre las etnias, en relación al sobrepeso y obesidad, (p>0,05. Observamos que las indígenas tenían una alta ingesta de frutas, azúcares y mieles. El 87 y 88% de las mujeres indígenas de ambas etnias estudiadas refirieron no consumir lácteos y derivados y entre 65 y 69% refirieron no consumir verduras. Conclusiones: Observamos un elevado porcentaje de obesidad y sobrepeso, un bajo consumo de lácteos y verduras y un alto consumo de azúcares, relacionados posiblemente a cambios en los aspectos alimentarios y sus costumbres, influenciados por la cercanía a las zonas urbanas y el acceso a alimentos de menor precio y mayor contenido energético.

Agreements and Discrepancies between FDA Reports and Journal Papers on Biologic Agents Approved for Rheumatoid Arthritis: A Meta-Research Project.

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Gil Amarilyo

Full Text Available Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA which independently analyzes the raw data and reports the results on its website.This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis.Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy and withdrawal due to adverse events (safety. As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report, followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy.FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34 except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61 pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55 pairwise comparisons and were statistically significant in 5. The "signal" in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical.There was no empirical evidence to suggest biased estimates between the two

Utilização de controles de gestão nas maiores indústrias catarinenses

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Fabiano Maury Raupp

2006-04-01

Full Text Available Este artigo objetiva demonstrar o efetivo uso dos controles de gestão nas maiores indústrias catarinenses. A pesquisa caracteriza-se como um estudo exploratório do tipo levantamento ou survey. Utilizando como parâmetro indústrias com mais de 200 funcionários, a população do estudo, após al-guns ajustes realizados, consistiu de 250 empresas. Para essas foi enviado um questionário com perguntas abertas e fechadas, via e-mail, obtendo respostas de 36 empresas, que constituíram a amostra da pesquisa. Para tratamento dos dados optou-se por uma abordagem predominantemente quantitativa. Assim, inicia-se o artigo com uma incursão teórica no processo de gestão e nos controles de gestão. Em seguida, procede-se à descrição e análise dos dados, enfocando as características das empresas, o perfil dos respondentes, a utilização dos controles de gestão, as formas de disponibilização das informações geradas pelos controles, bem como os aspectos positivos e negativos percebidos pelos respondentes em relação aos controles de gestão utilizados. Os resultados da pesquisa mostram que as empresas valem-se de diversos tipos de controles a fim de auxiliar o processo de gestão.This article aims to demonstrate the effective use of management control systems among the biggest industries in Santa Catarina. The research is characterized as a exploratory survey. Using as a parameter industries with more than 200 employees, the study population, after some adjustments, consisted of 250 companies. A questionnaire with open and closed questions was sent by e-mail. We received answers from 36 companies, which constituted the research sample, using a predominantly quantitative approach for data treatment. The article begins with a theoretical review of the management process and management control systems. Next, data are described and analyzed, focusing on the companies' characteristics, the respondents' profiles, the use of management control

La diversidad cultural educativa indígena venezolana en el contexto socio-jurídico

OpenAIRE

Jacqueline Coromoto Guillén de Romero

2013-01-01

Desde el análisis metodológico jurídico-documental se realiza consideraciones sobre el tema de los pueblos indígenas, su reconocimiento y la educación intercultural bilingüe. Resaltando los postulados del Texto Constitucional de 1999, la Ley Orgánica de Pueblos y Comunidades Indígenas, los Convenios Internacionales conexos o relativos a la materia, suscritos por Venezuela y otras fuentes documentales. Se describe, el profundo cambio de perspectiva política, jurídica y cultural que reorienta l...

Timelines of translational science: From technology initiation to FDA approval.

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Laura M McNamee

Full Text Available While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010-2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p<0.0005. Technological maturation represents the longest stage of translation, and significantly impacts the efficiency of drug development.

FDA, CE mark or something else?-Thinking fast and slow.

Science.gov (United States)

Mishra, Sundeep

There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review

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Juan Carlos Martínez-Aguayo

2016-06-01

Full Text Available ABSTRACT Background The United States Food and Drug Administration (FDA has warned about the increased suicidality risk associated with the use of selective serotonin reuptake inhibitors (SSRI and venlafaxine in children and adolescents. Objectives To critically appraise the available evidence supporting the FDA Black box warning concerning to the use of antidepressants in child and adolescents. Methods A critical review of articles in Medline/PubMed and SciELO databases regarding the FDA Black box warning for antidepressants, and the impact of FDA warnings on antidepressant prescriptions and suicide rates. Results The warning was based on surveys that did not report either cases of suicide nor a significant difference supporting an increased suicidality rate. The concept was defined in an ambiguous way and there is currently more available evidence to support such definition. The use of SSRI and venlafaxine has been associated to lower suicidality rates, but the prescription fall due to the warning increased suicide rates. Discussion Suicidality is an inherent feature of depressive disorders so it would be desirable to consider how much of the phenomenon may be attributed to antidepressants per se. It would be appropriate to consider that suicide rates might increase also as a consequence of the warning.

The FDA's failure to address the lack of generalisability of antidepressant efficacy trials in product labelling.

Science.gov (United States)

Zimmerman, Mark

2016-06-01

According to the US Food and Drug Administration's (FDA's) regulations, the criteria used to select patients into registration studies should be addressed in a product's label. The FDA's labelling guidelines, which specifically indicate that the routine exclusion of patients of a certain level of severity should be noted in the label, has been uniformly ignored. © The Royal College of Psychiatrists 2016.

Entre Didjazá y la Zandunga: iconografía y autorrepresentación indígena de las mujeres del Istmo de Tehuantepec, Oaxaca

Directory of Open Access Journals (Sweden)

Gabriela Zamorano Villarreal

2005-03-01

Full Text Available Cuestionando la existencia de lo que muchas veces se ha explicado como “la mirada india”, el presente artículo pregunta cómo las imágenes producidas por indígenas existen en diálogo con otras representaciones visuales y escritas sobre lo indígena. Para ello retomaré algunas de las reflexiones que se han comentado alrededor de la abundante iconografía sobre las mujeres indígenas del istmo de Tehuantepec, y trataré de situarlas en relación con las autorrepresentaciones indígenas actuales.

As estratégias das indústrias de farinha de trigo e de massas alimentícias do Rio Grande do Sul

Directory of Open Access Journals (Sweden)

Pascoal José Marion Filho

2011-04-01

Full Text Available A pesquisa identifica as estratégias praticadas nas indústrias de farinha de trigo e de massas alimentícias do Rio Grande do Sul no ano de 2007. É uma pesquisa exploratória baseada nas estratégias competitivas de Porter (1980 e de Mintzberg (1988, que utiliza na análise dados de questionários respondidos pelas empresas. Os resultados da pesquisa mostram que entre as estratégias de Porter, destacam-se a de custos mais baixos, na indústria de farinha de trigo, e a diferenciação, na indústria de massas. Entre as tipologias de Mintzberg, a qualidade do produto é considerada pelos gestores como sendo o grande diferencial competitivo nas duas indústrias.

Seminario-taller del gdri «apocamo»*: autonomización política indígena y planes de vida

OpenAIRE

Chaumeil, Jean-Pierre

2014-01-01

En la última década, diversos pueblos indígenas de la Amazonía noroccidental han venido elaborando sus «planes de vida». Estos planes son fruto de un trabajo participativo en el que las sociedades indígenas expresan sus anhelos y objetivos para su futuro, y por lo tanto, constituyen el punto de partida para la elaboración de su agenda política. En el grupo de investigación internacional «Apocamo», cuyo objetivo es analizar el proceso actual de transformación del marco político indígena así c...

La etnicidad cuestionada: Ancestralidad en las hijas e hijos de inmigrantes indígenas oaxaqueños en Estados Unidos

OpenAIRE

María Eugenia HERNÁNDEZ MORALES; Laura VELASCO ORTIZ

2015-01-01

Este artículo analiza el dilema identitario y de pertenencia en los hijos de inmi-grantes indígenas oaxaqueños en Estados Unidos, a través del estudio de tres di-mensiones de la ancestralidad: el lugar de origen, la vida comunitaria y la lengua indígena. El artículo documenta distintos cursos del proceso de etnización entre jóvenes de origen mixteco, zapoteco y triqui, nacidos o crecidos en Estados Unidos; metodológicamente se basa en tres talleres con activistas del Frente Indígena de Organi...

Comunidades indígenas de la provincia de Chimborazo, Ecuador:: permanencia de la sombra del régimen de hacienda

OpenAIRE

Tuaza Castro, Luis Alberto

2014-01-01

Este ensayo analiza la actual situación política indígena, a partir del acercamiento al proceso histórico de las comunidades indígenas de la zona Totorillas del cantón Guamote, Ecuador. Se argumenta que, después de la disolución de la hacienda, emergieron nuevas formas de liderazgo indígena; sin embargo, señala la compleja pervivencia de las antiguas formas de liderazgo que imposibilita la unidad de las comunidades y la consecución de un proyecto político único de largo alcance. This paper...

Entre la justicia indígena y la ordinaria: dilema aún por resolver

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Filipo Ernesto Burgos Guzmán

2008-12-01

Full Text Available La Constitución de 1991 propició un cambio en las relaciones con las minorías étnicas en general y en aras de su protección existe el reconocimiento de derechos colectivos y fundamentales de grupo. Dentro de ellos, uno trascendental: la jurisdicción indígena. Hoy, 17 años después de la entrada en vigencia de la nueva Constitución y de haberse reconocido a los indígenas su propias leyes y jueces, su sentido y razón de ser se ha ido aclarando y ampliando por la jurisprudencia constitucional, al abrigo del tratado internacional 169 de 1989 de la oit y la decisiones de la Corte Interamericana de Justicia. No obstante, cuando revisamos los conflictos de competencias suscitados, encontramos que cuando se resuelve u otorga competencia a la justicia ordinaria o indígena, en casos concretos llevados ante el Consejo Superior de la Judicatura, la visión de este tribunal no es acorde con el avance constitucional y en ocasiones parecería estar bajo el amparo de la Constitución monocultural de 1886.

Entre la justicia indígena y la ordinaria: dilema aún por resolver

Directory of Open Access Journals (Sweden)

Filipo Ernesto Burgos Guzmán

2008-01-01

Full Text Available La Constitución de 1991 propició un cambio en las relaciones con las minorías étnicas en general y en aras de su protección existe el reconocimiento de derechos colectivos y fundamentales de grupo. Dentro de ellos, uno trascendental: la jurisdicción indígena. Hoy, 17 años después de la entrada en vigencia de la nueva Constitución y de haberse reconocido a los indígenas su propias leyes y jueces, su sentido y razón de ser se ha ido aclarando y ampliando por la jurisprudencia constitucional, al abrigo del tratado internacional 169 de 1989 de la oit y la decisiones de la Corte Interamericana de Justicia. No obstante, cuando revisamos los conflictos de competencias suscitados, encontramos que cuando se resuelve u otorga competencia a la justicia ordinaria o indígena, en casos concretos llevados ante el Consejo Superior de la Judicatura, la visión de este tribunal no es acorde con el avance constitucional y en ocasiones parecería estar bajo el amparo de la Constitución monocultural de 1886.

Inequidad en la utilización de servicios de salud reproductiva en Colombia en mujeres indígenas y afrodescendientes

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Camilo Noreña-Herrera

2015-12-01

Full Text Available Resumen Se analizó la utilización de servicios de salud reproductiva (atención prenatal, parto y posparto, según la etnia de las mujeres, a partir de la Encuesta Nacional de Demografía y Salud 2010 de Colombia. La etnia fue medida por auto- reconocimiento (indígenas, afrodescendientes y ninguna y se estimaron modelos logísticos para cada servicio. Encontramos que, respecto a quienes no pertenecen a ninguna etnia, la utilización de servicios de salud reproductiva es menor en las mujeres indígenas y afrodescendientes. En los modelos de regresión se encontró que mujeres indígenas tienen menores posibilidades de un número adecuado de controles prenatales (OR = 0,61, así como también afrodescendientes. Igual situación para la atención institucional del parto: indígenas (OR = 0,33, afrodescendientes (OR = 0,60; y en control posparto: indígenas (OR = 0,80, afrodescendientes (OR = 0,80. En conclusión, existen inequidades en la utilización de servicios de salud reproductiva en las mujeres de grupos étnicos de Colombia que deben ser atendidas con estrategias gubernamentales que garanticen el derecho a la salud.

Literatura, indústria cultural e formação humana

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Fhiladelfio Joana Alves

2003-01-01

Full Text Available Este trabalho aborda questões referentes à literatura e aos produtos da indústria cultural, especialmente aos chamados romances "cor-de-rosa", focalizando as potencialidades de diferentes discursos na formação da subjetividade. As protagonistas dos romances O Quinze e As Três Marias, de Rachel de Queiroz são utilizadas como referência. Nesta perspectiva, evidencia-se a impregnação das criações ficcionais, atuando, de forma subconsciente e inconsciente, nas camadas profundas da personalidade, que pode em alguns casos, ampliar o conhecimento e a experiência humanos, aguçar os meios de expressão, despertar o senso crítico, mas em outros, reforçar a alienação da realidade. Conclui que enquanto a literatura oferece a possibilidade de libertar, os produtos da indústria cultural, ou seja, a literatura de massas, constituem um convite à alienação, ao conformismo, uma vez que tendem a inculcar estereótipos e preconceitos.

Estado nutricional y aspectos alimentarios de mujeres indígenas del departamento de Presidente Hayes, Paraguay

OpenAIRE

Gloria Echagüe; Valentina Díaz; Laura Mendoza; Pamela Mongelos; Graciela Giménez; Malvina Paez; Florentina Laspina; Amalia Castro; María Isabel Rodríguez; Patricia Araújo; Wilberto Castro; Ramón Marecos; Santiago Evers; Gerardo Deluca; Alejandra Picconi

2015-01-01

Introducción: Las comunidades indígenas presentan un mayor riesgo de inseguridad alimentaria y malnutrición, menor disponibilidad de recursos, y una creciente dependencia de alimentos más baratos aunque con un alto grado de procesamiento. Objetivo: Identificar el estado nutricional y aspectos alimentarios en mujeres indígenas de tres comunidades del Departamento de Presidente Hayes, Chaco Paraguayo. Metodología: Estudio observacional de diseño transversal con componente analítico, que incluyó...

Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.

Science.gov (United States)

Bradford, W David; Kleit, Andrew N

2015-07-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. Copyright © 2014 John Wiley & Sons, Ltd.

Acesso dos usuários indígenas aos serviços de saúde de Cuiabá, Mato Grosso, Brasil

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Silvana Cardoso Gomes

Full Text Available Resumo: O presente estudo teve por objetivo avaliar o acesso dos usuários indígenas aos serviços de saúde de média e alta complexidades do Município de Cuiabá, Mato Grosso, Brasil, a partir da Casa de Saúde Indígena (CASAI Cuiabá. Foi realizado um estudo de caso único na CASAI Cuiabá com abordagem qualitativa. Os dados foram obtidos por meio da observação das rotinas de trabalho da CASAI Cuiabá, entrevistas semiestruturadas com profissionais e gestores do Distrito Sanitário Especial Indígena (DSEI Cuiabá e CASAI Cuiabá, e análise documental. Para análise dos dados, foi elaborada uma matriz derivada do modelo teórico-lógico de acessibilidade e validada por meio do método Delphi a um grupo de especialistas na temática de saúde indígena. Apesar de avanços trazidos pela CASAI na melhoria da acessibilidade indígena, persistem barreiras sócio-organizacionais, culturais e geográficas no acesso à média e alta complexidades do município estudado. Recomenda-se a formulação de estratégias específicas para a melhoria do acesso aos serviços de saúde dos povos indígenas mato-grossenses.

Direito e Antropologia nas Definições de Territórios e Grupos Indígenas no Brasil: da Comunidade Indígena da Borboleta

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Ledson Almeida

2012-09-01

Full Text Available No Rio Grande do Sul, município de Salto do Jacuí, concentram-se acampadas, em dois locais distintos, cerca de cem famílias. Passaram a viver em acampamentos há cerca de quinze anos como forma de organização, diante do Estado e da sociedade regional, enquanto grupo indígena. Esta forma de organização foi motivada pela conquista do território reivindicado ao órgão indigenista oficial desde finais da década de oitenta. Hoje, reconhecidos como os Kaingang da Borboleta, este grupo de famílias ainda aguarda as resoluções fundiárias para ocupar um local definitivo capaz de garantir sua existência. É sobre as definições deste grupo e de sua trajetória histórica que trata este artigo.PALAVRAS CHAVES:  Kaingang da Borboleta, etnicidade, direitos indígenas, território indígenaABSTRACT:  In Rio Grande do Sul, district of Salto do Jacuí, gathered, camped out in two separate locations, there are approximately one hundred families. They began to organize themselves in camps nearly fifteen years ago as a way of appearing  before the State and regional society as an indigenous group. This form of organization was motivated by the conquest of territory claimed to the official indigenous organization since the late eighties. Today, recognized as the Butterfly Kaingang, this group of families is still waiting for land resolutions to occupy a permanent location which can guarantee its existence. It's about the definitions of this group and its historical background that this article deals about.KEYWORDS: Butterfly Kaingang,  ethnicity, indigenous rights, Indian territory

FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR

Science.gov (United States)

An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing.  Br

La legislación internacional sobre pueblos indígenas en el ordenamiento territorial y planes de desarrollo económico

OpenAIRE

Ibañez Sánchez, Miguel

2016-01-01

La situación de los pueblos indígenas ha sido largamente documentada en la historia peruana y ha estado ligada al despojo de sus tierras, territorios y recursos naturales. El modelo extractivo de crecimiento económico ha incrementado las actividades mineras, forestales y la producción de petróleo, en territorios de pueblos indígenas. Por otro lado, el ordenamiento territorial, la zonificación ecológica y los incentivos a la inversión privada, cada vez excluyen a los pueblos indígenas poniendo...

Maternal characteristics associated with pregnancy exposure to FDA category C, D, and X drugs in a Canadian population.

Science.gov (United States)

Yang, Tubao; Walker, Mark C; Krewski, Daniel; Yang, Qiuying; Nimrod, Carl; Garner, Peter; Fraser, William; Olatunbosun, Olufemi; Wen, Shi Wu

2008-03-01

To estimate the frequency of exposure to prescription Food and Drug Administration (FDA) category C, D, and X drugs in pregnant women, and to analyze the maternal characteristics associated with such an exposure. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 was chosen for the study. The rate of exposure to FDA category C, D, or X drugs recorded in the pharmacist database was estimated. Associations of exposure to FDA category C, D, and X drugs with maternal characteristics were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 575 women were included in this study. Among them, 3604 (19.4%) had exposure to one or more FDA category C, D, and X drugs during pregnancy. Category C drugs were the most frequently used drugs (15.8%), followed by D drugs (5.2%), and X drugs (3.9%). Women with chronic health conditions had fourfold at increased risk of exposure than women without. Regardless of health status, women who were or =3, and who were on social assistance plan were at increased risk of pregnancy exposure to these drugs. About 19.4% pregnant women are exposed to FDA C, D or X drugs during pregnancy. Women with chronic diseases, younger age, increased parity, and under social assistance are at increased risk of exposure to FDA C, D, or X drugs. Copyright 2008 John Wiley & Sons, Ltd.

Rapport de 2010 sur l'état de l'évaluation du développement en Inde ...

International Development Research Centre (IDRC) Digital Library (Canada)

En Inde, des données empiriques donnent à penser que l'évaluation du développement est en déclin, tant sur le plan du nombre que de la qualité des évaluations. Toutefois, il existe très peu de données écrites, voire aucune, sur la situation de l'évaluation en Inde, ni sur les facteurs en cause. Ce projet permettra donc de ...

FDA Developments: Food Code 2013 and Proposed Trans Fat Determination

NARCIS (Netherlands)

Grossman, M.R.

2014-01-01

268 Reports EFFL 4|2014 USA FDA Developments: Food Code 2013 and Proposed Trans Fat Determination Margaret Rosso Grossman* I. Food Code 2013 and Food Code Reference System Since 1993, the US Food and Drug Administration has published a Food Code, now updated every four years. In November 2013, the

Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines.

Science.gov (United States)

Klara, Kristina; Kim, Jeanie; Ross, Joseph S

2018-05-01

Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.

Significados construídos en indígenas universitarios sobre sustancias psicoactivas y programas de prevención

Directory of Open Access Journals (Sweden)

Isabel Cristina Posada-Zapata

2017-05-01

Full Text Available En las universidades hay estudiantes de diversos grupos étnicos lo que genera un contexto para la pluralidad cultural. Es necesario comprender los significados frente al uso de plantas tradicionales y la diferencia de esta práctica frente al uso de sustancias psicoactivas (spa con fines recreativos en indígenas universitarios. Objetivo: analizar los significados construidos por indígenas sobre el uso de plantas tradicionales, el consumo de spa y los programas de prevención en una universidad de la ciudad de Medellín. Metodología: investigación cualitativa, utilizando como herramienta metodológica la Teoría Fundamentada. Se usó la técnica del muestreo teórico; a partir de 602 indígenas estudiantes se eligió una muestra representativa de 16 por sus cualidades regionales. Las técnicas de recolección que se utilizaron fueron, la entrevista y los grupos focales que permitieron realizar la codificación y la categorización de la información. Resultados: los estudiantes indígenas reconocen que el contexto de la universidad, los vínculos sociales y la integralidad de los programas de prevención son factores determinantes en el consumo de spa. Conclusiones: los participantes consideraron que el Departamento de Bienestar Universitario debe crear programas específicos para el fortalecimiento de la cultura indígena, atendiendo y respetando de esta forma los significados de uso de plantas tradicionales y diferenciarlo de las spa.

America, you are digging your grave with your spoon--should the FDA tell you that on food labels?

Science.gov (United States)

Card, Melissa M

2013-01-01

R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.

Web 2.0 trænger ind i skolen

DEFF Research Database (Denmark)

Mehlsen, Camilla

2010-01-01

Det er ikke bare et stigende antal cyber kids, der presser på for at få web 2.0 ind i skolen. Flere uddannelsespolitiske tekster sætter nu fokus på, at elevernes it- og mediekompetencer skal være "i et web 2.0-perspektiv". Hvad skal der til, for at vi får en skole 2.0? Asterisk aflægger rapport fra...

Isolation and characterization of exosome from human embryonic stem cell-derived c-myc-immortalized mesenchymal stem cells

NARCIS (Netherlands)

Lai, Ruenn Chai; Yeo, Ronne Wee Yeh; Padmanabhan, Jayanthi; Choo, Andre; De Kleijn, Dominique P V; Lim, Sai Kiang

2016-01-01

Mesenchymal stem cells (MSC) are currently the cell type of choice in many cell therapy trials. The number of therapeutic applications for MSCs registered as product IND submissions with the FDA and initiation of registered clinical trials has increased substantially in recent years, in particular

Las mujeres indígenas venezolanas y sus logros en los albores del Siglo XXI

OpenAIRE

Rincón-Soto, Lucía del Carmen

2014-01-01

El artículo ofrece un recuento del paradigmático proceso de empoderamiento de las indígenas venezolanas y un balance de cómo su pensamiento se ha articulado para fortalecer su identidad. Se realiza un breve recorrido de la situación de las mujeres desde el proceso de colonización hasta los albores del siglo XXI. Si bien las mujeres indígenas latinoamericanas, en general, y las venezolanas, en particular, tienen muchos desafíos, no se puede dejar de destacar su valiosa participación en los esc...

A General Construction of IND-CCA2 Secure Public Key Encryption

DEFF Research Database (Denmark)

Kiltz, Eike; Malone-Lee, John

2003-01-01

We propose a general construction for public key encryption schemes that are IND-CCA2 secure in the random oracle model. We show that the scheme proposed in [1, 2] fits our general framework and moreover that our method of analysis leads to a more efficient security reduction....

De besluitvorming over werkzaamheid en veiligheid van rosiglitazon bij de FDA en de EMA. Wat zijn de lessen?

NARCIS (Netherlands)

Pouwels, Koen; Van Grootheest, Kees

2013-01-01

The rosiglitazone decision process at FDA and EMA. What should we learn? In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone while the FDA decided to restrict its use. These actions were taken because rosiglitazone had been associated with an increased risk of

Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?

Science.gov (United States)

Rosania, Larry

2010-01-01

Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective.

FDA drug safety communications: a narrative review and clinical considerations for older adults.

Science.gov (United States)

Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A

2012-08-01

The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older

Pure- and Mixed-Gas Permeation Properties of Highly Selective and Plasticization Resistant Hydroxyl-Diamine-Based 6FDA Polyimides for CO2/CH4 Separation

KAUST Repository

Alaslai, Nasser Y.

2016-01-05

The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.

Pure- and Mixed-Gas Permeation Properties of Highly Selective and Plasticization Resistant Hydroxyl-Diamine-Based 6FDA Polyimides for CO2/CH4 Separation

KAUST Repository

Alaslai, Nasser Y.; Ghanem, Bader; Alghunaimi, Fahd; Litwiller, Eric; Pinnau, Ingo

2016-01-01

The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.

A Good Year: FDA Approved Nine New Cancer Drugs in 2014

Science.gov (United States)

In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.

Impact of the FDA warning of potential ceftriaxone and calcium interactions on drug use policy in clinical practice.

Science.gov (United States)

Esterly, John S; Steadman, Emily; Scheetz, Marc H

2011-06-01

In September 2007, the FDA issued an alert recommending that ceftriaxone and calcium-containing solutions should not be administered to any patient within 48 h of each other. Due to the widespread use of ceftriaxone, significant concern was expressed by the greater healthcare community about the warning, which the FDA eventually retracted in April of 2009. We sought to quantify the impact of the warning on healthcare institutions. A survey was administered to the membership of the Society of Infectious Diseases Pharmacists to quantify perceived changes in ceftriaxone use among healthcare institutions across the United States. A survey of Infectious Diseases experts was conducted. Participants were queried for hospital policies/drug use statistics during two times: immediately after the FDA warning and approximately 13 months post warning (preceding the FDA retraction). Related changes in formulary, drug-use policy, and the number of employee hours that were devoted to addressing the FDA warning were assessed. Ninety-four surveys representing 94 hospital systems were included in the analysis. Approximately half (n = 49, 52%) of respondent institutions enacted at least one drug-use policy change based on the warning; one institution removed ceftriaxone from a clinical protocol. Institutions' final interpretations of the warning differed slightly from initial understanding of the warning, and there was an overall minor decrease in the perceived use of ceftriaxone. The majority of those surveyed (n = 70, 74%) estimated that their respective institutions devoted between 1 and 49 employee hours to address the warning. Hospitals with ID pharmacists had minimal changes to ceftriaxone use after the 2007 FDA warning. Specialized pharmacists may be uniquely situated to help hospitals interpret global recommendations locally.

El emprendimiento de la mujer indígena campesina en Bolivia. Hacia una propuesta de desarrollo

OpenAIRE

Padilla-Meléndez, A.; Ciruela-Lorenzo, Antonio Manuel

2015-01-01

Objetivo y justificación: el emprendimiento indígena y la perspectiva de género en el emprendimiento han tenido una importancia creciente en la literatura en los últimos años. Se ha encontrado como la actividad emprendedora de la mujer difiere, en cuanto a motivaciones y circunstancias (en muchos casos más complicadas), de la del hombre. Además, y en relación al emprendimiento específicamente indígena, se aprecia una notable importancia del capital social para el desarrollo del mismo. Se p...

Análisis de la motricidad de la cultura indígena Sikuani: un estudio para el departamento del Meta (Colombia)

OpenAIRE

Velásquez Arjona, Alberto; Campos Polo, Fernando

2010-01-01

La comunidad indígena Sikuani, confinada desde hace cuarenta años en el resguardo indígena Wayoko, región de la Orinoquia colombiana, fue concentrada allí contra su tradición nómada. A pesar de sus vicisitudes, los miembros de la comunidad se han caracterizado por un férreo apego a sus tradiciones.El proceso de transformacion de la comunidad Sikuani, el cual se ha denominado como transculturización, lleva ya varios años haciendo estragos en la idiosincracia indígena. A pesar de que muchas com...

Know Violence in Childhood – Inde : Défense des droits ...

International Development Research Centre (IDRC) Digital Library (Canada)

Know Violence in Childhood – Inde : Défense des droits, communication et mobilisation des médias. Know Violence in Childhood (KVIC) est une initiative mondiale d'apprentissage et de défense des intérêts visant à stimuler la coordination de l'action pour mettre fin à la violence faite aux enfants. Elle met à profit ...

Science, law, and politics in the Food and Drug Administration's genetically engineered foods policy: FDA's 1992 policy statement.

Science.gov (United States)

Pelletier, David L

2005-05-01

The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.

Migración y diferenciación étnica en Guatemala. Ser indígena en un contexto de globalización

OpenAIRE

Santiago Bastos

1999-01-01

En este artículo se discute si el concepto de la desterritorialización de las identidades, que se asocia a la globalización, es útil para describir la nueva relación que mantienen las poblaciones indígenas de Latinoamérica con el espacio, como efecto del proceso de dispersión que viven desde hace unas décadas. La comparación del proceso migratorio entre hogares indígenas y no indígenas que residen en tres espacios populares de la ciudad de Guatemala muestra al...

Dos paradojas del multiculturalismo colombiano: la espacialización de la diferencia indígena y su aislamiento político

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Diana Bocarejo

2011-01-01

Full Text Available La práctica del multiculturalismo en Colombia se ejerce en el contexto de complejas disputas y reclamos provenientes de diferentes actores sociales, beneficiarios o no de derechos diferenciales. En este artículo se estudian dos paradojas de los arreglos políticos del multiculturalismo en Colombia, relacionadas con la forma como se espacializa la diferencia indígena, y con ellas, se examinan sus implicaciones políticas. La primera paradoja es la forma como se juzga quién es o no un sujeto indígena legal, utilizando como una de las características predominantes el que un indígena viva en "su" resguardo rural. La segunda paradoja es el aislamiento político que se ha configurado entre indígenas y campesinos. De esta forma, se pretende demostrar la relevancia de estudiar no solo las políticas culturales, sino también la cultura política que posibilita y construye el multiculturalismo.

Negros e indígenas ocupam o templo branco: ações afirmativas na UFRGS

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Arabela Campos Oliven

Full Text Available Resumo: Na maioria dos países do mundo ocidental, universidades que formam a elite costumam ser redutos da branquidade refratários a grupos socialmente excluídos. No Brasil, com mais da metade da população formada por pretos e pardos, as universidades públicas sempre foram um território quase exclusivamente branco. O Rio Grande do Sul, estado brasileiro com a segunda maior percentagem de população branca do país, reflete esse quadro. Ele enaltece o legado dos grupos imigrantes de origem europeia em contraste com a pequena visibilidade atribuída à contribuição da população negra e indígena. No período 2008 a 2012, a Universidade Federal do Rio Grande do Sul, a mais importante do estado, implementou uma política de ação afirmativa que aumentou as oportunidades de alunos pretos, pardos e indígenas entrarem em seus cursos de graduação. O artigo discute essa política - sua aprovação, características, implantação, avaliação e reformulação, assim como seus resultados. Analisa a experiência de um grupo de universitários negros e indígenas, que foram dos primeiros a ingressar na UFRGS através da reserva de vagas. Ao final, aponta os significados das políticas de inclusão de negros e indígenas nas universidades públicas brasileiras e os desafios que elas representam para essas instituições.

Estado nacional y nacionalidades indígenas.

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José Mauro Gagliardi

2011-08-01

Full Text Available Cuando se estudian los pueblos indígenas de Brasil la primera cosa que se constata es su reducción de mayoría a minoría. Los traslados del interior para el litoral, las matanzas y las epidemias son hechos que sirven para ilustrar ese proceso de exterminación. A partir del siglo XVIII, com la administración pombalina se inició la formación delEstado Nacional que de forma planificada impuso a los indios una forma de actuar y de pensar. La finalidad del reglamento sobre las misiones de catequesis y civilización de los indios de 1845 era también la de incorporarlos a los patrones de vida occidentales. Se trataba de preparar a esos pueblos para un tipo de trabajo uniformado, hablando la lengua nacional, como una conciencia económica y cultural homogénea. Durante el periodo republicano, los mecanismos de integración de los pueblos indígenas a la sociedad nacional se hicieron todavía más eficaces. Si tomamos como referencia la formación del Estado Nacional verificaremos que es una tendencia de esa forma de organización política la de uniformizar las relaciones sociales y disolver la diversidad cultural. El estudio de ese fenómeno ayudará para la comprensión más profunda de las relaciones entre los indios y la sociedad brasileña y probablemente ayudará a programar estrategias que aseguren la vida de aquellos que todavía sobreviven.

Literatura indígena para crianças: o desafio da interculturalidade

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Ana Paula Franco Nobile Brandileone

2018-01-01

Full Text Available El objetivo de este artículo es realizar una reflexión crítica acerca de la producción literaria infantil indígena. Para eso, se recurre a la problematización teórica centrada en el concepto de transculturación, conforme a Canclini (2007, articulada a los estudios sobre literatura infantil y juvenil brasilera de Moratti (2001, Ceccantini (2010 y Martha (2016. Como objeto de análisis son abordadas las obras Paiquerê: el paraíso de los Kaingangs, de Cléo Busatto, y Karú Tarú: el pequeño chamán, de Daniel Munduruku, ambas editadas en 2009. Este análisis permite la proposición de la hipótesis de que, en la literatura indígena más reciente, direccionada al público infantil, se encuentran opciones estéticas condicionadas a un intento de divulgación cultural no siempre afecto a la construcción de textos literarios de mejor cualidad. Así, se torna necesario reflexionar, en el caso de las narrativas, acerca de ideas y concepciones puestas al servicio de un compromiso ideológico cuyos reflejos, en el texto literario, se muestran contradictorios en relación con el lector, el cual tiende a percibir en la cultura indígena un elemento exótico y estereotipado, lo que poco contribuye para construir una relación intercultural democrática y humanizadora.

The "natural" aversion: the FDA's reluctance to define a leading food-industry marketing claim, and the pressing need for a workable rule.

Science.gov (United States)

Farris, April L

2010-01-01

As of 2009, the "natural foods" industry has become a 22.3 billion dollar giant and "all-natural" is the second-leading marketing claim for all new food products. Even in such a flourishing market, the Food and Drug Administration (FDA) has never defined the term "natural" through rulemaking. FDA and the U.S. Department of Agriculture (USDA) have instead created separate, non-identical policy statements governing the use of the term "natural," and FDA has abandoned efforts to define "natural" through rulemaking in the face of more pressing priorities. In absence of any governing federal standard, consumer advocacy groups and warring food industries have attempted to define "natural" to fit their preferences through high-stakes litigation of state law claims, leaving courts free to apply diverging standards without the expertise of FDA. Recent case law from federal district courts and the Supreme Court leaves little hope that FDA's current policy statement will preempt state law causes of action. To prevent a potential patchwork of definitions varying by state, and to create a legitimate standard resting on informed scientific expertise rather than consumer whims, FDA should engage in rulemaking to define the term "natural." This paper concludes by sketching potential formulations for such a rule based on FDA's previous successful rule-making ventures and standards used by natural foods retailers.

Zoom on India | Gros plan sur l’Inde

Directory of Open Access Journals (Sweden)

2012-05-01

Full Text Available Indian Energy Production and Consumption (in Million Tonnes of Oil EquivalentProduction et consommation d’énergie en Inde (en millions de tonnes d’équivalent pétroleSource: World Bank, World Bank Development Indicators, 2010.Indian Oil, Gas and Coal Imports (in Million Tonnes of Oil Equivalent, 2008*Importations indiennes de pétrole, de gaz et de charbon (en millions de tonnes d’équivalent pétrole, 2008** 2009 for coal data | 2009 pour les données sur le charbon.Sources: British Petroleum...

FDA, CE mark or something else?—Thinking fast and slow

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Sundeep Mishra

2017-01-01

Full Text Available There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: “substantial equivalence,” “PMDA,” “CE mark,” “Notified body,” “510K” and “PMA” but the actual approval process can also be very tardy, inconsistent and expensive.

Small Area Estimate Maps: Does the FDA Regulate Tobacco? - Small Area Estimates

Science.gov (United States)

This metric is defined as a person 18 years of age or older who must have reported that he/she believes that the United States Food and Drug Administration (FDA) regulates tobacco products in the U.S.

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

Directory of Open Access Journals (Sweden)

Nguyen Diane

2013-01-01

Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by

Subjetividades indígenas impuestas y desafiantes en el discurso televisivo

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Ana Ramos

2002-12-01

Full Text Available Rebelión del Arauco y Otra Justicia, Otra Cultura son informes de investigación periodística. Ambas narrativas -tomadas del discurso televisivo- construyen un "otro indígena" como premisa de un argumento más amplio. El primero pertenece a un programa chileno en el que el indígena es un ejemplo de violencia ejercida contra el "sistema". El segundo corresponde a un informativo argentino en el que la construcción del conflicto intra e interétnico ilustra la inoperancia del "estado". El propósito de este trabajo consiste en analizar las estrategias simbólicas utilizadas por la instancia enunciativa del programa televisivo y aquellas que emergen de los eventos citados; y a través de los ejemplos seleccionados mostrar el modo en que estas estrategias pueden ser utilizadas en el discurso televisivo para confirmar o desafiar estereotipos en torno a la construcción conjunta del ser indígena y el ser nacional."Arauco´s rebellion" and "Other justice, other culture" are press investigation reports. Both narratives -from television discourse- construct an "indigenous other" like premises of a broader argument. The first one belongs to a Chilean programme in which the indigenous actions are shown like examples of violence against "the system". The second one is from an Argentine news programme in which the construction of an intra and inter-ethnic conflict illustrates the inoperation of the State. The intention of this article is to analyse the symbolic strategies used by the enunciative instances of television programmes, and those that emerge from the cited events; and through the selected examples to show the way in which these strategies may be used in the television discourse to confirm or challenge stereotypes that surround the simultaneous construction of the indigenous being and the national being.

Revisión histórica del fenómeno educativo indígena en el nororiente delCauca (Colombia

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William García Bravo

2011-10-01

Full Text Available El trabajo que presentamos pretende, desde un punto de vista comparado, y en perspectiva histórica, presentar la realidad del fenómeno educativo colombiano, en concreto las políticas y prácticas educativas en zonas indígenas. La realidad colombiana se presta a muchas intervenciones y reflexiones filosóficas, educativas y políticas acerca de los indígenas y su papel, representatividad y visibilidad en la sociedad. La educación indígena sigue un proceso de marcha, en ocasiones parece lento, en otras rápido; en este momento siguen existiendo problemas prioritarios como la tierra, la producción, la salud, etc. No obstante para las hoy comunidades indígenas, el planteamiento educativo es muy importante y lo enmarcan en su problemática actual que hoy viven como comunidades indígenas.The present paper seeks,from a comparative perspective, and historical perspective, presenting the phenomenon Colombian education,specifically educational policies and practices in indigenous areas. The situation in Colombia, lends itself to many interventions and philosophical, educational and policy on indigenous people and its role,representation and visibility in society.Indigenous education is an ongoing process,sometimes seems slow, others fast, at this time remain priority issues such as land,production, health, etc. But for today, indigenous communities, the educational approach is very important and fall within its current problems today live as indigenous communities.

Minería en territorio en el Perú : un estudio a partir del derecho al desarrollo en un país minero e indígena

OpenAIRE

Osorio, Ricardo Antonio Serrano

2013-01-01

El presente estudio tiene por objetivo analizar la posibilidad de admitir la viabilidad de la actividad minera en territorio indígena en el Perú con el fin de estimular y conciliar el desarrollo de un país minero e indígena que, por un lado, precisa de los recursos naturales y, por el otro, necesita de proteger, fomentar e salvaguardar la integridad de los pueblos indígenas que la conforman. En ese sentido, en busca de resultados, primero se pasó a delimitar la organización ind...

Network-Based Real-time Integrated Fire Detection and Alarm (FDA) System with Building Automation

Science.gov (United States)

Anwar, F.; Boby, R. I.; Rashid, M. M.; Alam, M. M.; Shaikh, Z.

2017-11-01

Fire alarm systems have become increasingly an important lifesaving technology in many aspects, such as applications to detect, monitor and control any fire hazard. A large sum of money is being spent annually to install and maintain the fire alarm systems in buildings to protect property and lives from the unexpected spread of fire. Several methods are already developed and it is improving on a daily basis to reduce the cost as well as increase quality. An integrated Fire Detection and Alarm (FDA) systems with building automation was studied, to reduce cost and improve their reliability by preventing false alarm. This work proposes an improved framework for FDA system to ensure a robust intelligent network of FDA control panels in real-time. A shortest path algorithmic was chosen for series of buildings connected by fiber optic network. The framework shares information and communicates with each fire alarm panels connected in peer to peer configuration and declare the network state using network address declaration from any building connected in network. The fiber-optic connection was proposed to reduce signal noises, thus increasing large area coverage, real-time communication and long-term safety. Based on this proposed method an experimental setup was designed and a prototype system was developed to validate the performance in practice. Also, the distributed network system was proposed to connect with an optional remote monitoring terminal panel to validate proposed network performance and ensure fire survivability where the information is sequentially transmitted. The proposed FDA system is different from traditional fire alarm and detection system in terms of topology as it manages group of buildings in an optimal and efficient manner.Introduction

FDA Food Code recommendations: how do popular US baking shows measure up?

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Valerie Cadorett

2018-05-01

Full Text Available The purpose of this study was to determine if popular US baking shows follow the FDA Food Code recommendations and critical food safety principles. This cross-sectional study examined a convenience sample of 75 episodes from three popular baking shows. The three shows were about competitively baking cupcakes, competitively baking cakes, and baking in a popular local bakery. Twenty-five episodes from each show were viewed. Coding involved tallying how many times 17 FDA Food Code recommendations were or were not followed. On each show, bare hands frequently came in contact with ready-to-eat food. On a per-hour basis, this occurred 80, 155, and 176 times on shows 1-3, respectively. Hands were washed before cooking three times on the three shows and never for the recommended 20 seconds. On each show, many people touched food while wearing jewelry other than a plain wedding band, for an average of at least 7 people per hour on each show. Shows 1-3 had high rates of long-haired bakers not wearing hair restraints (11.14, 6.57, and 14.06 per hour, respectively. Shows 1 and 2 had high rates of running among the bakers (22.29 and 10.57 instances per hour, respectively. These popular baking shows do not demonstrate proper food safety techniques put forth by the FDA and do not contribute the reduction of foodborne illnesses through proper food handling.

FDA approves efavirenz. Food and Drug Administration.

Science.gov (United States)

Highleyman, L

1998-10-01

The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.

A CIDADANIA EM QUESTÃO: organizações regionais indígenas e TICs na Pan-Amazônia

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James León Parra Monsalve

2017-08-01

Full Text Available As passadas mobilizações que tiveram amplo suporte na internet como as da Primavera Árabe, no Egito, ou as de Junho de 2013, no Brasil, apontam novas configurações do ato conetivo nas redes digitais. Mas, deve-se dizer que um outro espaço-tempo é experimentado nas ações organizacionais indígenas, pois elas estão inseridas numa luta secular perante a subvaloração histórica dos seus fundamentos não-modernos. Neste trabalho apresentam-se alguns dos principais resultados de uma pesquisa desenvolvida entre 2011 e 2014 com a Associação Inter-étnica de Desenvolvimento da Selva Peruana (AIDESEP, a Confederação de Povos Indígenas do Oriente, Chaco e Amazônia da Bolívia (CIDOB e a Coordenação das Organizações Indígenas da Amazônia Brasileira (COIAB.   PALAVRAS-CHAVE: Organizações Indígenas Amazônicas; TICs; Cidadania.     ABSTRACT Past mobilizations that had broad support on the Internet as the Arab Spring in Egypt or June 2013 in Brazil suggest new configurations of connective act on digital networks. But it must be said that another space-time is experienced in indigenous organizational actions because they are embedded in a secular struggle against the historical undervaluation of its non-modern foundations. This paper presents some of the main results of a research conducted between 2011 and 2014 with the Inter-ethnic Association of Peruvian Rainforest Development (AIDESEP, the Confederation of Indigenous Peoples of the East, Chaco and Amazon of Bolivia (CIDOB and the Coordination of Indigenous Organizations of the Brazilian Amazon (COIAB.   KEYWORDS: Amazon Indigenous Organizations; ICT; Citizenship.     RESUMEN Las pasadas movilizaciones que tuvieron amplio soporte en internet como las de la Primavera Árabe, en Egipto, o las de Junio de 2013, en Brasil, apuntan nuevas configuraciones del acto conectivo en las redes digitales. Pero, se debe decir que otro espacio-tiempo experimentan las acciones

Educación en el medio indígena de Chihuahua

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Eva América Mayagoitia Padilla

2011-04-01

Full Text Available Este artículo forma parte del estudio de egresados de la Licenciatura en Educación Preescolar y Primaria para el Medio Indígena (LEPEPMI 90, que la Universidad Pedagógica Nacional Unidad 081 desarrolló con los estudiantes que concluyeron sus estudios en la subsede de Creel, Chih., durante el período comprendido entre 1995 y 2008. Se desarrolló con el propósito de analizar la dimensión formativa y el mercado laboral de los egresados a fin de retroalimentar el currículo. Se trata de un estudio descriptivo en el que se analizan algunas de las características de la práctica docente en el medio indígena, como uno de los contextos educativos de mayor complejidad, en virtud de que el logro de la calidad de la educación que reciben los niños y niñas está mediado por otros muchos factores que, sin duda, trascienden a las instituciones educativas.

Synthesis and characterization of a microporous 6FDA-polyimide made from a novel carbocyclic pseudo Tröger's base diamine: Effect of bicyclic bridge on gas transport properties

KAUST Repository

Abdulhamid, Mahmoud A.

2017-10-12

A newly designed carbocyclic pseudo Tröger\\'s base diamine (CTB) monomer, 2,8-dimethyl-3,9-diamino-5,6,11,12-tetrahydro-5,11-methanodibenzo[a,e][8]annulene (CTBDA) and its isomeric analogue 2,8-dimethyl-(1,7)(4,10)(3,9)-diamino-5,6,11,12-tetrahydro-5,11-methanodibenzo[a,e][8]annulene (iCTBDA), were designed for the synthesis of microporous 6FDA-based polyimides (6FDA-CTBDA and 6FDA-iCTBDA). Both polyimides were soluble, exhibited excellent thermal stability of ∼490 °C, and had high surface areas of 587 m2 g−1 (6FDA-CTBDA) and 562 m2 g−1 (6FDA-iCTBDA). A 6FDA-based polyimide derived from 4,10-dimethyl-3,9-diamino-6H,12H-5,11-methanodibenzo[b,f][1,5]-diazocine (6FDA-TBDA) was made for comparison to investigate the effects of the basic tertiary nitrogen functionality in the Tröger\\'s base diamine on the polymer properties relative to the carbocyclic 6FDA-CTBDA analogue. 6FDA-TBDA displayed lower gas permeabilities but moderately higher gas-pair permselectivities than 6FDA-CTBDA. The enhanced permselectivity of 6FDA-TBDA resulted exclusively from higher diffusion-based selectivity. Direct gas sorption measurements demonstrated that the basicity in the Tröger\\'s base bridge moiety enhanced the sorption capacity of CO2 only slightly and had no effect on the CO2/CH4 solubility selectivity in 6FDA-TBDA vs. 6FDA-CTBDA.

Year 2000 (Y2K) computer compliance guide; guidance for FDA personnel. Food and Drug Administration. Notice.

Science.gov (United States)

1999-05-14

The Food and Drug Administration (FDA) is announcing the availability of a new compliance policy guide (CPG) entitled "Year 2000 (Y2K) Computer Compliance" (section 160-800). This guidance document represents the agency's current thinking on the manufacturing and distribution of domestic and imported products regulated by FDA using computer systems that may not perform properly before, or during, the transition to the year 2000 (Y2K). The text of the CPG is included in this notice. This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a new CPG, and it will be included in the next printing of the Compliance Policy Guides Manual. This CPG is intended for FDA personnel, and it is available electronically to the public.

Estimation of Viable Biomass In Wastewater And Activated Sludge By Determination of ATP, Oxygen Utilization Rate And FDA Hydrolysis

DEFF Research Database (Denmark)

Jørgensen, Poul-Erik; Eriksen, T.; Jensen, B.K.

1992-01-01

ATP content, oxygen utilization rate (OUR) and fluorescein diacetate (FDA) hydrolysis were tested for the ability to express the amount of viable biomass in wastewater and activated sludge. The relationship between biomass and these activity parameters was established in growth cultures made...... with biomass, while FDA hydrolysis in the sludge failed to show any such correlation. Conversion factors of 3 mg ATP/g dw, 300 mg O2/h g dw and 0.4 A/h (mg dw/ml) for ATP, OUR and FDA methods, respectively, were calculated. When the methods were applied for in situ determinations in four different wastewater...... plants, it was found that ATP content and respiration rate estimated viable biomass to range from 81 to 293 mg dw/g SS for raw wastewater and from 67 to 187 mg dw/g SS for activated sludge with a rather weak correlation between ATP and respiration measurements. The FDA hydrolysis estimated viable biomass...

Insurgencia y Alianza: Estrategias de la participación indígena en el Proceso de Independencia en Charcas. 1809-18121

Directory of Open Access Journals (Sweden)

María Luisa SOUX

2011-04-01

Full Text Available El artículo analiza las estrategias de participación indígena en el proceso de independencia en Charcas a partir del estudio de la sublevación que se dio entre 1809 y 1812. La autora propone que la participación de los grupos indígenas en este suceso fue de índole política, tomando parte en actos planificados y organizados desde su propia perspectiva. Estas sublevaciones ocurrieron cuando existieron posibilidades de triunfo y cuando la percepción de la injusticia se hizo intolerable. Las estrategias adoptadas en estos momentos también fueron propiamente indígenas, y pretendían mantener el equilibrio entre Estado y ayllus, de tal manera que se garantizase el acceso a la tierra y a sus recursos. La conspiración y sublevación del Alto Perú aquí estudiada, que se originó por el nombramiento por parte de la corona del cacique y por el estado de lucha revolucionaria que acompañó a los movimientos juntistas de Chuquisaca y La Paz, demuestra la existencia de un proyecto político indígena integrador en cuyo fracaso radica un devenir distinto en el proceso independentista y, a la larga, la exclusión indígena en la actual Bolivia.

Uma análise da Indústria do Entretenimento - Estudo de caso: a artista Beyoncé

OpenAIRE

Marques, Guilherme Vasconcelos

2018-01-01

O objetivo principal deste trabalho fornecer opções de diagnósticos acerca do papel da celebridade Beyoncé na indústria do entretenimento e na vida de mulheres negras no Brasil. Para faze-lo, utiliza-se os estudos trazidos acerca da Indústria Cultural, estabelecendo seus pontos fortes para a análise e suas limitações. A partir da introdução deste termo e de seu enquadramento dentro das Relações Internacionais, faz-se uma breve descrição acerca de parte do conteúdo produzido pela cantora Beyon...

FDA & digital mammography: why has FDA required full field digital mammography systems to be regulated as potentially dangerous devices for more than 10 years?

Science.gov (United States)

Nields, Morgan W

2010-05-01

Digital mammography is routinely used in the US to screen asymptomatic women for breast cancer and currently over 50% of US screening centers employ the technology. In spite of FDAs knowledge that digital mammography requires less radiation than film mammography and that its equivalence has been proven in a prospective randomized trial, the agency has failed to allow the technology market access via the 510(k) pre market clearance pathway. As a result of the restrictive Pre Market Approval process, only four suppliers have received FDA approval. The resulting lack of a competitive market has kept costs high, restricted technological innovation, and impeded product improvements as a result of PMA requirements. Meanwhile, at least twelve companies are on the market in the EU and the resulting competitive market has lowered costs and provided increased technological choice. A cultural change with new leadership occurred in the early 90's at FDA. The historical culture at the Center for Devices and Radiological Health of collaboration and education gave way to one characterized by a lack of reliance on outside scientific expertise, tolerance of decision making by unqualified reviewers, and an emphasis on enforcement and punishment. Digital mammography fell victim to this cultural change and as a result major innovations like breast CT and computer aided detection technologies are also withheld from the market. The medical device law, currently under review by the Institute of Medicine, should be amended by the Congress so that new technologies can be appropriately classified in accordance with the risk based assessment classification system detailed in Chapter V of the Federal Food, Drug, and Cosmetic Act. A panel of scientific experts chartered by the NIH or IOM should determine the classification appropriate for new technologies that have no historical regulatory framework. This would be binding on FDA. Unless the law is changed we will likely again experience

FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR Staging

Science.gov (United States)

An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing.  Br

Priorização de práticas verdes em GSCM: estudo de casos com empresas da indústria do pêssego

Directory of Open Access Journals (Sweden)

Miguel Afonso Sellitto

Full Text Available Resumo O objetivo deste artigo é definir prioridades para as práticas verdes que são observadas em cadeias de suprimentos da indústria do pêssego. O método de pesquisa é a modelagem qualiquantitativa. As unidades de análise são quatro empresas focais da cadeia de suprimentos da indústria do pêssego da região de Pelotas. Foi elaborado um modelo para estruturar práticas verdes observadas na indústria, a partir da literatura sobre GSCM (Gestão Verde da Cadeia de Suprimento. O modelo inclui três construtos: Estratégia, Inovação e Operações. Dezesseis práticas verdes presentes na literatura foram distribuídas entre os construtos. Um grupo focado de três especialistas adaptou o modelo à indústria do pêssego de Pelotas, eliminando três práticas. As restantes foram priorizadas por gestores das empresas com apoio do método AHP de análise multicriterial. Com base no resultado, cinco práticas foram consideradas prioritárias para a indústria: Ecodesign, Cooperação, Avaliação de Desempenho, Compras Verdes e Manufatura Verde, nesta ordem.

The FDA's decision-making process: isn't it time to temper the principle of protective paternalism?

Science.gov (United States)

Brandt, Lawrence J

2008-05-01

The authors conducted a well-designed, multinational, large study of women younger than 65 yr of age with irritable bowel syndrome (IBS) with a mixed pattern of diarrhea and constipation (IBS-M) or constipation (IBS-C) and showed that a statistically greater percentage of patients in each group responded to tegaserod compared with patients treated with placebo. Practicality looms large, however, in that the Food and Drug Administration (FDA) disallowed the continued marketing of tegaserod because of cardiovascular safety concerns, and it now is only available under a restricted access program. The wisdom of this decision aside, it is disturbing that the FDA revealed a zero-tolerance for any significant risk of disease when a drug (e.g., tegaserod) was used for a nonlife-threatening condition; the FDA chose to neglect any potential benefit of significant improvement in quality of life, while at the same time allowing the continued availability of sildenifil for erectile dysfunction and other medications (e.g., rosiglitazone and nonsteroidal anti-inflammatory drugs [NSAIDs]), each with a far greater risk of cardiovascular complications. Whether tegaserod will be re-released and, if so, under what conditions, is yet to be determined, as is the question of whether the FDA will decide to allow a more transparent decision-making process with input from all interested parties affected by their decision.

Entrepreneurs’ Exploratory Perseverance in Learning Settings

NARCIS (Netherlands)

Muehlfeld, K.S.; Urbig, Diemo; Weitzel, Utz

We introduce “exploratory perseverance” as a novel construct that captures perseverant behavior in settings in which several alternatives can be explored and evaluated. We suggest that entrepreneurs display exploratory perseverance reflected by a tendency to keep exploring broader sets of

Flujos migratorios intrarregionales en Latinoamérica: el caso de los indígenas guatemaltecos en la frontera sur de México

Directory of Open Access Journals (Sweden)

Daniel Vega Macías

2017-12-01

Full Text Available Las migraciones internacionales de población indígena en Latinoamérica merecen particular atención debido a que suelen desarrollarse en mayor desventaja socioeconómica respecto de la población no indígena. El objetivo de esta investigación es examinar la situación que guardan los indígenas guatemaltecos que se desplazan en la frontera sur de México. Este estudio de tipo empírico está basado en un análisis cuantitativo de los microdatos de la Encuesta sobre Migración en la Frontera Sur de México (EMIF-Sur correspondiente al año 2015. Una apreciación global del trabajo permite argumentar que la mitad de los migrantes captados en la encuesta son indígenas, quienes se encuentran en desventaja en prácticamente todas las variables socioeconómicas analizadas, lo cual los torna un grupo particularmente vulnerable.

La jurisdicción indígena en el Sistema Penal Acusatorio

Directory of Open Access Journals (Sweden)

Jorge Enrique Benavides Ascuntar

2011-01-01

Full Text Available La investigación surge de la necesidad de solucionar, a través del procedimiento del SPA, el conflicto de competencia jurisdiccional por la injusticia e impotencia de las autoridades indígenas de no poder juzgar a sus miembros, cuando incurren en "delitos". El problema parte de lo general de la base principial dogmática y la incongruencia con normas orgánicas constitucionales aborígenes, específicamente la jurisdicción indígena,la que debe atemperarse a la Constitución para arribar al tema particular de la resolución del conflicto de jurisdicciones. Para este propósito se analizaron e interpretaron los valores, principios y la constitucionalidad de la jurisdicción indígena, tomando incluso las expresiones semánticas del art. 246 de la Constitución Nacional. Los resultados de investigación de esta propuesta surgen de la colisión de los sistemas jurídico y normativo de culturas diferentes e iguales, deeste análisis constitucional, legal y jurisprudencial, se concreta la propuesta de una Audiencia Especial comorequisito de procedibilidad para solucionar el conflicto de competencias jurisdiccionales. Este procedimiento,no regulado legalmente, es una omisión legislativa; en este sentido estos resultados se recomienda tenerlos encuenta como propuesta para adicionar a la Ley 906 de 2004, o en la promulgación de la ley de coordinación d jurisdicciones o por la Corte Constitucional en revisiónde Acción de Tutela, en sentencias sobre temas de este carácter.

Current and future state of FDA-CMS parallel reviews.

Science.gov (United States)

Messner, D A; Tunis, S R

2012-03-01

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently proposed a partial alignment of their respective review processes for new medical products. The proposed "parallel review" not only offers an opportunity for some products to reach the market with Medicare coverage more quickly but may also create new incentives for product developers to conduct studies designed to address simultaneously the information needs of regulators, payers, patients, and clinicians.

Trenching as an exploratory method

International Nuclear Information System (INIS)

Hatheway, A.W.; Leighton, F.B.

1979-01-01

The critical nature of siting nuclear power plants has led to increased emphasis on exploratory trenching. Trenching is the most definitive of all subsurface exploratory methods; it permits inspection of a continuous geologic section by both geologists and regulatory authorities and makes possible the preparation of a graphic log that delineates both obvious and subtle geologic features. About one of every two nuclear plant licensing efforts utilizes exploratory trenching. Many geologic hazards, such as ''capable'' faults, can be detected from trench exposures; they may otherwise remain undetected. Trenches must be judiciously located, survey-controlled, excavated safely and adequately shored, logged in detail, and properly diagnosed. Useful techniques of trench logging include thorough cleaning of the trench walls, teamwork between geologist and recorder, logging against a carefully surveyed baseline and vertical reference grid, and panoramic photography.Soils, including paleosols, and glacial and glaciofluvial deposits present some of the most difficult media to log. Trench logs must be thoroughly interpreted and correlated so that they document the geologic conditions governing suitability of the site. Age-determination techniques utilized in exploratory trenching include petrographic analyses, quartz inclusion studies, clay mineralogic analyses, and radiometric methods

Language and Nutrition (Mis)Information: Food Labels, FDA Policies and Meaning

Science.gov (United States)

Taylor, Christy Marie

2013-01-01

In this dissertation, I address the ways in which food manufacturers can exploit the often vague and ambiguous nature of FDA policies concerning language and images used on food labels. Employing qualitative analysis methods (Strauss, 1987; Denzin and Lincoln, 2003; Mackey and Gass, 2005) that drew upon critical discourse analysis (Fairclough,…

21 CFR 14.15 - Committees working under a contract with FDA.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... committee: (1) The committee shall give public notice of its meetings and agenda, and provide interested...

FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR

Science.gov (United States)

The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected.  The National Cancer In

The rosiglitazone decision process at FDA and EMA : What should we learn?

NARCIS (Netherlands)

Pouwels, Koen B.; van Grootheest, Kees

2012-01-01

In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased

Pesquisa na área Sateré-Mawé: a descoberta de talentos indígenas

Directory of Open Access Journals (Sweden)

Maria Alice Becker

Full Text Available Este artigo trata da sensibilização de professores indígenas Sateré-Mawé para identificar talentos ou altas habilidades e das oficinas de arte, ocorridas durante o desenvolvimento do projeto integrado de Educação, Sustentabilidade e Hábitos Nutricionais por uma equipe interdisciplinar da Universidade Federal do Amazonas (UFAM. Na sensibilização, explanou-se sobre leis da Educação Especial e utilizou-se um questionário com perguntas a respeito de liderança, criatividade, capacidade de planejamento, expressão gráfica e verbal como exemplos. Embora os professores indígenas não tenham utilizado o instrumento durante o desenrolar do projeto integrado, apresentaram sugestões para ações futuras. As oficinas artísticas fizeram parte das atividades do projeto, que envolveu ações de formação, pesquisa e produção de material pedagógico para as escolas indígenas, sendo utilizada a metodologia de pesquisa-ação (Thiollent, 2003. O resultado das oficinas de arte mostrou que alguns professores apresentavam talento para representar graficamente aspectos da sua cultura e vida de contato íntimo com a natureza.

Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014

Directory of Open Access Journals (Sweden)

Benjamin Hixon

2017-02-01

Full Text Available Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC. The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9% of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%. The three most frequently reported labeling changes were warnings (68.7%, precautions (58.6%, and patient package insert/medication guide (23.2%. Case reports resulted in the greatest number of documented literature types (n = 791, followed by randomized controlled trials (n = 76, and case control/cohort studies (n = 74. Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%, compared to LOE A (17.1%, and LOE C (14.1% (p = 0.007. Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Research

Limites da autonomia e da autodefesa indígena: experiências mexicanas

Directory of Open Access Journals (Sweden)

John Gledhill

2012-12-01

Full Text Available Este trabalho analisa a situação atual das lutas dos povos indígenas mexicanos para alcançarem a autodeterminação e transcenderem os limites do multiculturalismo neoliberal. Após examinar as relações entre a radicalização das demandas indígenas e as transformações do Estado mexicano, a análise centra-se na história recente de uma comunidade indígena nahua no litoral do estado de Michoacán, que tem uma longa e bem-sucedida história de defesa de suas terras comunais, e numa comunidade purépecha no planalto central do mesmo estado, que tem sido sua aliada. A violência de atores externos, que aflige estas comunidades, revela as consequências da penetração em todos os níveis de governo do crime organizado, mas a análise também mostra como a capacidade das comunidades indígenas para resistirem pode ser prejudicada pela sua desarticulação interna pelas mesmas forças, num clima de impunidade em que a violência paramilitar pode avançar uma variedade de interesses econômicos regionais e transnacionais.This text analyzes the present situation of the struggles of Mexico's indigenous peoples to achieve self-determination and transcend the limits of neoliberal multiculturalism. After reviewing the relationships between the radicalization of indigenous demands and transformations of the Mexican state, our analysis focuses on the recent history of a Nahua indigenous community on the Pacific coast of Michoacán state, which has a long and successful history of defense of its communal lands. We also look at a Purhépecha community in the central highlands of Michoacán which has been the first community's ally. The violence of external actors that afflicts these communities reveals the consequences of the penetration of all levels of government by organized crime. However, our analysis also shows how the capacity of indigenous communities to resist can be undermined by their internal disarticulation by the same forces, which

El proceso de construcción de la identidad del Cabildo Indígena Ambiká-Pijao en el marco de la Política Pública para Pueblos Indígenas en la localidad de Usme. (2005-2015)

OpenAIRE

Daza Alfonso, Felipe Alexander

2016-01-01

El propósito del presente diagnóstico es analizar el proceso de construcción de la identidad del Cabildo Indígena Ambiká-Pijao en la localidad de Usme en la ciudad de Bogotá, desde el año 2005 hasta 2015. Este diagnóstico busca analizar la identidad en el marco de la Política Pública para Pueblos Indígenas de la ciudad de Bogotá, teniendo como elementos centrales las variables del territorio y su pérdida debido al desplazamiento en muchos casos forzado, la cultura, y las características sobre...

A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus.

Science.gov (United States)

Ekins, Sean; Freundlich, Joel S; Coffee, Megan

2014-01-01

We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.

Movilización indígena y su inclusión en la participación política institucional en México

Directory of Open Access Journals (Sweden)

Antonio Alejo Jaime

2009-07-01

Nacional Indígena Plural por la Autonomía, ANIPA, la cual propone alternativas para resolver las adversidades que aquejan a los pueblos originarios. Ésta surge en el contexto de la jornada “500 años del Descubrimiento de América”. Es con la aparición del Ejército Zapatista de Liberación Nacional (EZLN en 1994, que ANIPA logra una importante difusión de la demanda política que enarbolan las comunidades indígenas como el reconocimiento, respeto y autonomía de los pueblos indígenas. ANIPA ha participado en diversos foros y espacios de encuentro entre los poderes Ejecutivo y Legislativo y las organizaciones indígenas, que le permitieron agrupar diversas estructuras, dando pie a lo que hoy es ANIPA-Agrupación Política Nacional, con elfin de continuar abriendo espacios de expresión e interacción entre ellos. ANIPA ha decidido buscar vías pacíficas y de diálogo para alcanzar la solución a las demandas indígenas. ANIPA-APN no se vislumbra como un partido político; pero sí como un nuevo camino democrático que permita la inserción de las comunidades indígenas en la vida política del país, proponiendo la construcción de un Estado multiétnico y una nueva sociedad multicultural.

A Comprehensive Review of US FDA-Approved Immune Checkpoint Inhibitors in Urothelial Carcinoma

Directory of Open Access Journals (Sweden)

Fu-Shun Hsu

2017-01-01

Full Text Available Few effective treatment options are available for patients with advanced or metastatic urothelial carcinoma (UC after unsuccessful first-line platinum-based chemotherapy. To date, immune checkpoint inhibitors are novel therapeutic agents for UC treatment. From May 2016 to May 2017, five anti-PD-1/PD-L1 monoclonal antibodies received accelerated or regular approval from the US Food and Drug Administration (FDA for the treatment of patients with locally advanced or metastatic UC. The present comprehensive review presents the background information of these five US FDA-approved anticancer agents to provide a basic but concise understanding of these agents for advanced studies. We summarize their immune checkpoint mechanisms, clinical efficacy, recommended usage protocols, adverse events, and the limitations of the PD-L1 biomarker assays.

Acceso y permanencia a la Educación Superior de mujeres indígenas mayangnas, URACCAN Las Minas, 2009 – 2010

Directory of Open Access Journals (Sweden)

Sorayda Del Carmen Herrera Siles

2012-10-01

Full Text Available Se ha descrito el acceso y permanencia en la Educación Superior de mujeres indígenas mayangnas en el Recinto URACCAN Las Minas, período 2000-2009, en las comunidades de Wasakín y el Cuarto Territorio Indígena Mayangna (Mayangna Sauni Arunka, ubicadas en los municipios de Rosita y Bonanza, Región Autónoma del Atlántico Norte (RAAN. Se realizó en el marco en una perspectiva cualitativa, a partir del enfoque etnográfico con el apoyo de la observación y la entrevista. La diferencia cultural y la pobreza que implica la falta de recursos monetarios en efectivo, han sido los principales obstáculos que limita a las jóvenes indígenas al acceso y permanencia de la Educación Superior. Las mujeres indígenas no tienen la posibilidad de ejercer plenamente sus derechos ciudadanos en igualdad de condiciones, carecen de oportunidades para desarrollar sus capacidades y talentos. Los embarazos han sido la causa principal por la cual la mayoría de las mujeres indígenas abandonen sus estudios superiores. Se destaca asimismo, que solamente la URACCAN hace presencia en el territorio Mayangna Sauni Arunka y la comunidad Wasakín para promover el acceso y la permanencia de las mujeres a la Educación Superior por medio de un sistema de becas.

Le nouveau visage de la philanthropie en Inde | CRDI - Centre de ...

International Development Research Centre (IDRC) Digital Library (Canada)

Connectez-vous avec Nirojan sur LinkedIn. La philanthropie est en hausse en Inde et le phénomène devrait continuer à croître. La nouvelle richesse transforme également le visage des dons de charité et retient l'attention du public. Par conséquent, le nombre de conseillers en philanthropie augmente aussi. La relation ...

Indéfinis épistémiques en français et en japonais

Directory of Open Access Journals (Sweden)

Kaneko Makoto

2012-07-01

Full Text Available Cette étude vise à approfondir nos connaissances sur les indéfinis épistémiques (ceux qui expriment la lecture d’ignorance et manifestent une propriété sémantique "variation modale" à travers l’examen du “quelque” au singulier en français et l’indéfini prénominal en japonais. Les études précédentes sur les indéfinis épistémiques dans les autres langues montrent que certains d’entre eux transmettent aussi la lecture de polarité négative et/ou celle de libre choix dans les environnements différents, et proposent, afin de rendre compte d’une telle divergence, soit 1 une approche pragmatique qui consiste à analyser, en réduisant la sémantique d’un indéfini à celle de la disjonction d’alternatives, les différentes lectures comme des implicatures conversationnelles dérivées de la disjonction, soit 2 une approche sémantique qui les traite comme des implicatures conventionnelles. Après avoir montré qu’aucune des deux approches n’explique pas pleinement toute seule les distributions des indéfinis épistémiques en japonais et en français, il est d’abord soutenu, pour l’indéfini prénominal du japonais, qu’en raison des facteurs diachroniques, il reçoit deux interprétations dans les différents environnements, parallèlement à l’ambiguïté d’une particule (interrogative ou disjonctive qui en fait partie : i interprétation de la question indirecte parenthétique, qui entraîne, dans une phrase épisodique ou avec la modalité épistémique, la lecture d’ignorance comme une implicature conventionnelle ; ii interprétation de la disjonction d’alternatives, qui dérive, avec la modalité déontique, la lecture de libre choix comme une implicature conversationnelle. La lecture de polarité négative n’est véhiculée par aucune des deux interprétations, étant donné i l’incongruité de demander l’identité du référent dont l’existence est niée et ii la portée n

Misiones-patrones e indígenas-siringueros: el caucho entre los chacobos del Beni (siglo xx

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Lorena I. Córdoba

2013-04-01

Full Text Available El artículo describe la continuidad paradójica entre la crítica de los misioneros católicos a la captación de mano de obra indígena durante el llamado «boom cauchero» en la Amazonía boliviana, a fi nes del siglo XIX y comienzos del XX, y la relación más compleja que establecieron posteriormente los misioneros protestantes del Instituto Lingüístico de Verano con los chacobos (pano, desde 1955 hasta 1980, incentivando activamente a los indígenas a trabajar en la industria cauchera e integrarse en la economía regional.

“Al mejor servicio del rey”. Indígenas realistas en la contrarrevolución quiteña, 1809-1814

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Alexandra Sevilla Naranjo

2016-06-01

Full Text Available Este estudio explora las motivaciones y las formas en que las comunidades indígenas y sus caciques se articularon a la contrarrevolución quiteña, entre 1809 y 1814. Se busca visibilizar y problematizar las relaciones entre la elite criolla y la población indígena durante el período revolucionario, apartándose de las lecturas teleológicas que exaltan la construcción de la nación. A partir del análisis de casos especícos se evidencia que el realismo, surgido como respuesta al “juntismo”, de inicios del siglo XIX, fue una opción política y práctica para la población indígena de la Audiencia de Quito.

La noción de "indígena" en las prácticas estatales locales. El caso de tres comunas de la Araucanía, Chile

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Francisca de la Maza Francisca de la Maza Cabrera

2012-12-01

Full Text Available El artículo presenta una investigación etnográfica en torno a la noción de "lo indígena" en las prácticas estatales en tres comunas de la Región de la Araucanía. En Chile, desde el año 1993, con la ley indígena 19.253 se han implementado diversas acciones, programas sociales y de desarrollo bajo el prisma de una "política de la diferencia" o de "reconocimiento". Esto ha llevado a la incorporación cotidiana de diferentes expresiones de reconocimiento de lo indígena en las prácticas e interacciones sociales y locales, tanto en los agentes estatales como en los ciudadanos indígenas y no indígenas. Algunas de ellas se han institucionalizado, tales como la celebración del wetripantu ("año nuevo mapuche", mientras otras emergen en las interacciones cotidianas entre los agentes estatales y los ciudadanos que habitan la comuna. Este artículo busca desentrañar esas prácticas en la rutina anual, con el fin de aportar a la comprensión del impacto de la política indígena en la convivencia local.

Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-

Science.gov (United States)

2017-11-22

This final rule adopts without changes an interim final rule with request for comments published in the Federal Register on March 23, 2017. On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. The Drug Enforcement Administration (DEA) maintains FDA-approved products of oral solutions containing dronabinol in schedule II of the Controlled Substances Act.

El Límite a la Protección de las Tierras Indígenas de la Ley 19.253

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Mario Salamanca Huenchullán

Full Text Available Este trabajo aborda el tema del límite a la protección de las tierras indígenas, que como una exigencia del interés nacional introduce en la legislación chilena la Ley Indígena 19.253, en su relación con la expropiación para la construcción de obras públicas, que en virtud de la utilidad pública se construyen sobre estas mismas tierras.

Encontro Nacional de Estudantes Indígenas no Brasil: reflexões compartilhadas; Encuentro Nacional de Estudiantes Indígenas en Brasil: reflexiones compartidas; National Meeting of Indigenous Students in Brazil: shared reflections

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Michele Barcelos Doebber

2018-01-01

Full Text Available Resumo: Este texto se trata de resenha crítica das primeiras quatro edições do Encontro Nacional de Estudantes Indígenas (ENEI, evento que ocorre anualmente no Brasil desde 2013. A resenha evidencia, através da descrição e análise dos Encontros, bem como da experiência de participação das autoras, os desafios da relação intercultural entre universidade e coletivos ameríndios, fruto da presença crescente desses coletivos nas instituições públicas de ensino superior devido a implementação de políticas de ações afirmativas. A partir do registro de observação participante e de pesquisa documental nos relatórios dos encontros, apresentamos uma reflexão compartilhada que evidencia o ENEI como espaço de re-existência dos coletivos ameríndios. Ao passo em que enfrentam as manifestações da colonialidade nas universidades convencionais, organizam-se através de encontros autogestionados pelos próprios indígenas universitários que, na presença de suas lideranças, proporcionam o fortalecimento das trajetórias pessoais e coletivas e a ampliação das redes de articulação política. Consideramos que a presença disruptiva desses povos na universidade pode repovoar este espaço com conhecimentos e olhares outros, indagando sobre o modelo hegemônico que a funda e mantém, gerando transformações. Palavras-chave: Coletivos Indígenas; Universidade; Organização Política; Movimento Indígena.   Resumen: Este texto presenta una sistematización crítica de las primeras cuatro ediciones del Encuentro Nacional de Estudiantes Indígenas (ENEI, evento que se realiza anualmente en Brasil desde 2013. Se evidencia, a través de la descripción y análisis de los Encuentros, así como de la experiencia de participación de las autoras, los desafíos de la relación intercultural entre universidad y colectivos amerindios, fruto de la presencia creciente de esos colectivos en las instituciones públicas de enseñanza superior

Miradas encontradas: funcionarios reales, curas e indígenas en Yucatán durante el periodo colonial

OpenAIRE

Adriana Rocher Salas

2010-01-01

El presente texto estudia las diversas formas en que funcionarios civiles y eclesiásticos miraron a los indígenas de Yucatán durante el período colonial. La imagen que de los mayas construyeron quienes los gobernaron nos dará una visión más amplia de los diferentes esquemas impuestos para su gobierno espiritual y temporal y el carácter de la relación españoles-mayas yucatecos. Con este fin, como hilo conductor se tendrán los juicios construidos sobre la vida indígena respecto a tres aspectos ...

III. Grandes proyectos de inversión y grupos indígenas. Algunas experiencias en México

OpenAIRE

Hiernaux-Nicolas, Daniel

2014-01-01

Si bien el tema de los derechos indígenas se ha puesto nuevamente de moda por las reivindicaciones de grupos étnicos en México, particularmente en el contexto de los recientes eventos de Chiapas, numerosas cuentas faltan por saldar. Una de éstas, y no de las menores, es la relación entre los grupos indígenas en particular y campesinos en forma más general, y los llamados “grandes proyectos de desarrollo” cuyo mayor auge se dio entre los años sesenta y ochenta. Desde una perspectiva geográfica...

Update of the exploratory report Acrolein

NARCIS (Netherlands)

Slooff W; Bont PFH; Janus JA; Pronk MEJ; Ros JPM; ECO; PPCbv; ACT; LAE

1994-01-01

The report is an update of the exploratory report acrolein (Slooff et al., 1991) that served as a basis for the discussion during the exploratory meeting on acrolein in March 1992. The meeting supported the conclusion that priority should be given to the compartment air and to the risks to humans.

Training first responders on Radiological Dispersal Devices (RDDs) and Improvised Nuclear Devices (INDs) events

International Nuclear Information System (INIS)

Groves, Ken L.

2008-01-01

Full text: This paper will present an overview of the current training the author is presenting to First Responders (fire-fighters, emergency medical technicians, law enforcement and others) who may encounter either a Radiological Dispersal Device (RDD or Dirty Bomb) or an Improvised Nuclear Device (IND) as a part of their Emergency Response activities. The emphasis of the training is putting the radiological/nuclear material in perspective as compared with other Weapons of Mass Destruction (WMD) materials such as chemical and/or biological weapon agents. A goal of the training is to help this First Responder Community understand that under almost all conditions, they can perform their primary mission of 'putting out fires', rescuing and treating injured persons, and chasing 'bad guys' even in the presence of relatively large amount of radiological/nuclear contamination. The rare cases of high activity unshielded sources will be reviewed and explained. Current International guidance on dose 'limits' will be discussed. A discussion of the use of Time, Distance and Shielding as well as appropriate Personal Protective Clothing and how it will provide the needed protection while immediate actions take place early in an RDD/IND event, will take place. The use of appropriate radiation detection instrumentation, documented Standard Operating Procedures along with realistic training, drills and exercises are the key to a successful response to an RDD/IND event for this community of critical emergency responders. (author)

Pre-clinical and Clinical Development of Low Dose Methamphetamine for the Treatment of Traumatic Brain Injury

Science.gov (United States)

2014-12-01

Aim 3: Secure FDA approval of a phase I/II clinical trial plan and obtain an amended IND in preparation for initiating human clinical testing in TBI...Neurology 6:193–201. Raineri M, Gonzalez B, Goitia B, Garcia-Rill E, Krasnova IN, Cadet JL, Urbano FJ, Bisagno V. 2012. Modafinil abrogates

Mujer mapuche y retos de la justicia intercultural: aplicación del derecho propio indígena en delitos de violencia intrafamiliar

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Rosario Palma Ayala

2014-06-01

Full Text Available Este artículo analiza la manera en que los tribunales chilenos han aplicado el derecho propio indígena en casos de violencia intrafamiliar donde las víctimas son mujeres pertenecientes al pueblo mapuche. Se reflexiona en torno a la relación entre el derecho propio indígena y la respuesta estatal, planteándose que la respuesta que han dado los tribunales de justicia, respecto a que existe una colisión entre los derechos de las mujeres y los derechos de los pueblos indígenas, es aparente, existiendo alternativas de solución que respetan de manera integral los derechos de las mujeres mapuche.

Disputas por el gobierno de indígenas en la antigua Comisaría del Vaupés, 1960-1968

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Álvaro Andrés Santoyo

2010-01-01

Full Text Available En este artículo se reconstruyen, a partir de documentos de archivo, los ejes argumentativos de las disputas entre caucheros, misioneros y funcionarios alrededor de la regulación del trabajo indígena en el contexto de la explotación cauchera, como una manera de entender las discusiones existentes en las décadas de 1960 y 1970, sobre el gobierno de la población indígena de la antigua Comisaría del Vaupés. Dicha reconstrucción se realiza en tres apartados. En el primero se presenta la justificación, desde los caucheros, de la importancia de la industria del caucho para el progreso de la Comisaría y su influencia en el proceso de civilización de los indígenas. Enseguida, las querellas entre los tres actores sociales sobre la contratación de indígenas. Por último, el texto aborda el cierre de la disputas, a partir del análisis de la denominada Declaración de Miraflores, documento publicado por los misioneros católicos en la prensa colombiana en el que se denunciaron los abusos de los caucheros en la región.

Estado, crédito e planejamento no desempenho da indústria da construção naval brasileira 1990-2010

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Alcides Goularti Filho

2014-05-01

Full Text Available O objetivo deste artigo é discutir a história econômica recente da indústria da construção naval brasileira no período de 1990 a 2010, destacando a atuação do Estado, por meio de políticas públicas voltadas para a indústria nacional e do crédito vinculado ao Banco Nacional de Desenvolvimento Econômico e Social (BNDES. Nesse período de 20 anos, o setor naval brasileiro passou por dois momentos bem distintos: desmonte parcial e retomada das atividades. Além da introdução e das considerações finais, o artigo está dividido em três tópicos. No primeiro, será apresentada uma breve caracterização da indústria da construção naval, destacando seus aspectos produtivos, organizacionais e a participação mundial. Em seguida, será detalhado o processo de desmonte parcial da indústria naval, focando o processo de desnacionalização e a ausência de políticas públicas. E, por último, será destacada a retomada das atividades navais ancoradas nas encomendas da Petrobras em embarcações e offshore.

Los mayas del altiplano: supervivencia indígena en Chiapas y Guatemala

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Lovell, W. George

2002-06-01

Full Text Available En el contexto americano, pocos grupos indígenas han demostrado la capacidad de sobrevivir a lo largo de la historia como los mayas del altiplano. Hoy día en Chiapas existen más de un millón de indígenas mayas, un número que asciende a cinco o seis millones en el caso de Guatemala. Los pueblos mayas han respondido a la invasión y a la dominación para conservar elementos importantes de su cultura. Este artículo discute las formas en que los mayas del altiplano se han adaptado para sobrevivir a casi cinco siglos de conquista, identificando tres fases claves en su trayectoria histórica: (1 la experiencia colonial, que abarca los años entre 1524 y 1821; (2 una época de reforma y revolución, que corre de 1821 a 1954; y (3 un período de marginalización y descuido desde 1954 en adelante. Pese al desfío, los mayas del altiplano están equipados culturalmente para perdurar.

Innovations issues de la base en Chine et en Inde | IDRC ...

International Development Research Centre (IDRC) Digital Library (Canada)

Les innovations issues de la base sont celles qui émergent des systèmes de connaissances traditionnels et officieux d'un lieu, qu'on intègre ou non un savoir officiel. En Chine et en Inde, on n'a pas encore pleinement compris et mis à profit ce type d'innovation. Cette subvention financera une étude approfondie de ce type ...

Educación Superior y Pueblos Indígenas en América Latina

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Álvaro Guaymás

2016-10-01

Full Text Available El dossier que aquí presentamos resulta de un trabajo colaborativo iniciado a principios de este año en el marco de la Red Interuniversitaria Educación Superior y Pueblos Indígenas y Afrodescendientes de América Latina (RED ESIAL. Esta red, cuya creación ha sido impulsada y gestionada desde el Programa Educación Superior y Pueblos Indígenas y Afrodescendientes en América Latina (Programa ESIAL del Centro Interdisciplinario de Estudios Avanzados de la Universidad Nacional de Tres de Febrero, cuenta con la participación de cuarenta universidades de América Latina, habiendo sido la Universidad Nacional de Salta una de las primeras en adherir a la misma, por iniciativa del Centro de Investigaciones Sociales y Educativas del Norte argentino (Cisen.

Proyecto Vidas paralelas indígena: revelando el pueblo Piratapuia / Waíkhana del Amazonas, Brasil.

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Evelyn NERY

2012-03-01

Full Text Available Este relato de experiencia se refiere al grupo étnico Piratapuia o Waíkhana, que habita el noroccidente del Estado del Amazonas en el Brasil. En este caso, se aborda más especificamente el componente de ese grupo étnico residiendo en el municipio de Santa Isabel do Rio Negro. Se relata la historia del pueblo Saúde Indígena Tempus - Actas de Saúde Coletiva Revista Tempus Actas de Saúde Coletiva 80 Piratapuia más especificamente al componente de ese grupo étnico, en el municipio de Santa Isabel do Rio Negro. Se relata la historia del grupo étnico haciendo énfasis en su migración a partir del Alto Rio Negro para el curso medio del mismo, la influência de la misión saleciana y de la invasión de los buscadores de oro (garimpeiros, así como la convivencia con otras etnias (tukano y yanomami, entre otras. Son mostrados también detalles de la organización social que incluye la estrutura de clanes con sus jerarquías. Se describen las distintas asociaciones indígenas de la región que consiguieron forjar una conciencia en la población del municipío, en donde actualmente 90,0% se asume como perteneciente a grupos étnicos indígenas. Con respecto a la cultura, se detacan las prácticas de cura y auto-cuidado proporcionadas por los “benzederos”. La estructura de sanidad pertenece al polo de Sta. Isabel, con un hospital y una unidad básica de salud, siendo que el Distrito Especial Indígena de Salud fue ampliado para garantizar la cobertura al medio Rio Negro. Sin embargo, se señalan las dificultades generadas por las enormes distancias de desplazamiento.

Chloroquine, a FDA-approved Drug, Prevents Zika Virus Infection and its Associated Congenital Microcephaly in Mice.

Science.gov (United States)

Li, Chunfeng; Zhu, Xingliang; Ji, Xue; Quanquin, Natalie; Deng, Yong-Qiang; Tian, Min; Aliyari, Roghiyh; Zuo, Xiangyang; Yuan, Ling; Afridi, Shabbir Khan; Li, Xiao-Feng; Jung, Jae U; Nielsen-Saines, Karin; Qin, Frank Xiao-Feng; Qin, Cheng-Feng; Xu, Zhiheng; Cheng, Genhong

2017-10-01

Zika virus (ZIKV) has become a global public health emergency due to its rapidly expanding range and its ability to cause severe congenital defects such as microcephaly. However, there are no FDA-approved therapies or vaccines against ZIKV infection. Through our screening of viral entry inhibitors, we found that chloroquine (CQ), a commonly used antimalarial and a FDA-approved drug that has also been repurposed against other pathogens, could significantly inhibit ZIKV infection in vitro, by blocking virus internalization. We also demonstrated that CQ attenuates ZIKV-associated morbidity and mortality in mice. Finally, we proved that CQ protects fetal mice from microcephaly caused by ZIKV infection. Our methodology of focusing on previously identified antivirals in screens for effectiveness against ZIKV proved to be a rapid and efficient means of discovering new ZIKV therapeutics. Selecting drugs that were previously FDA-approved, such as CQ, also improves the likelihood that they may more quickly reach stages of clinical testing and use by the public. Copyright © 2017. Published by Elsevier B.V.

Condições de trabalho e automação: o caso do soprador da indústria vidreira

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Queiróz Maria de Fátima F

2001-01-01

Full Text Available OBJETIVO: Investigar como o controle de tarefas e o uso de diferentes tecnologias e de estrutura organizacional determinam o processo de saúde-doença. MÉTODOS: O estudo foi desenvolvido em duas indústrias vidreiras -- automática e manual --, no Município de São Paulo, Brasil, entre 1996 e 1997. A metodologia utilizada teve como base a análise ergonômica do trabalho. A pesquisa foi realizada utilizando-se estudo de caso e comparações entre dois grupos de trabalhadores, incluindo observação direta dos postos de trabalho, entrevistas e um questionário respondido por 41 trabalhadores: 14 da sopragem manual de vidro e 27 da operação da máquina automática. O questionário estruturado versava sobre queixas de saúde e características do trabalho e do posto. RESULTADOS: A comparação entre os dois grupos de trabalhadores apontou diferenças estatisticamente significativas em relação às respostas sobre o nível de ruído, as ferramentas de trabalho, a variação de postura no posto de trabalho e as queixas de dores nos braços. Foram detectados fatores de risco, tais como repetição dos movimentos para os trabalhadores da indústria manual e fatores da organização do trabalho nas duas indústrias, tais como ritmo, participação em decisões importantes e treinamento. CONCLUSÕES: O uso da metodologia ergonômica mostrou-se adequada. O estudo confirmou a exposição dos trabalhadores a intensidades elevadas de ruído e a altas temperaturas. Na indústria manual, o trabalhador parece desempenhar um papel que o faz se sentir mais importante, pois ele realiza uma parte significativa do trabalho total, diferentemente do trabalhador da indústria automática que está "vigiando" um processo em que a máquina é a produtora.

Condições de trabalho e automação: o caso do soprador da indústria vidreira

Directory of Open Access Journals (Sweden)

Maria de Fátima F Queiróz

2001-02-01

Full Text Available OBJETIVO: Investigar como o controle de tarefas e o uso de diferentes tecnologias e de estrutura organizacional determinam o processo de saúde-doença. MÉTODOS: O estudo foi desenvolvido em duas indústrias vidreiras -- automática e manual --, no Município de São Paulo, Brasil, entre 1996 e 1997. A metodologia utilizada teve como base a análise ergonômica do trabalho. A pesquisa foi realizada utilizando-se estudo de caso e comparações entre dois grupos de trabalhadores, incluindo observação direta dos postos de trabalho, entrevistas e um questionário respondido por 41 trabalhadores: 14 da sopragem manual de vidro e 27 da operação da máquina automática. O questionário estruturado versava sobre queixas de saúde e características do trabalho e do posto. RESULTADOS: A comparação entre os dois grupos de trabalhadores apontou diferenças estatisticamente significativas em relação às respostas sobre o nível de ruído, as ferramentas de trabalho, a variação de postura no posto de trabalho e as queixas de dores nos braços. Foram detectados fatores de risco, tais como repetição dos movimentos para os trabalhadores da indústria manual e fatores da organização do trabalho nas duas indústrias, tais como ritmo, participação em decisões importantes e treinamento. CONCLUSÕES: O uso da metodologia ergonômica mostrou-se adequada. O estudo confirmou a exposição dos trabalhadores a intensidades elevadas de ruído e a altas temperaturas. Na indústria manual, o trabalhador parece desempenhar um papel que o faz se sentir mais importante, pois ele realiza uma parte significativa do trabalho total, diferentemente do trabalhador da indústria automática que está "vigiando" um processo em que a máquina é a produtora.

21 CFR 111.610 - What records must be made available to FDA?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

Integration of new technology into clinical practice after FDA approval.

Science.gov (United States)

Govil, Ashul; Hao, Steven C

2016-10-01

Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

Stem-cell-derived products: an FDA update.

Science.gov (United States)

Moos, Malcolm

2008-12-01

The therapeutic potential of products derived from stem cells of various types has prompted increasing research and development and public attention. Initiation of human clinical trials in the not-too-distant future is now a realistic possibility. It is, therefore, important to weigh the potential benefits against known, theoretical and totally unsuspected risks in light of current knowledge to ensure that subjects participating in these trials are afforded the most reasonable balance possible between potential risks and potential benefits. There are no apparent differences in fundamental, qualitative biological characteristics between stem-cell-derived products and other cellular therapies regulated by the United States Food and Drug Administration (FDA). Existing authorities can, therefore, be applied. Nevertheless, these products do have properties that require careful evaluation.

18 CFR 430.11 - Advance notice of exploratory drilling.

Science.gov (United States)

2010-04-01

... exploratory drilling. 430.11 Section 430.11 Conservation of Power and Water Resources DELAWARE RIVER BASIN... exploratory drilling. The Commission encourages consultation with any project sponsor who is considering... project and prior to initiation of exploratory drilling. (a) Any person, firm corporation or other entity...

Articulación entre servicios de salud y “medicina indígena”: reflexiones antropológicas sobre política y realidad en Brasil

Directory of Open Access Journals (Sweden)

Esther Jean Langdon

2017-10-01

Full Text Available Este artículo contribuye al diálogo entre las ciencias sociales y la medicina social en América Latina a través de la exploración del pluralismo terapéutico en las políticas y servicios de salud indígena en Brasil. Revisa las investigaciones recientes en antropología, así como los conceptos y debates actuales, para examinar críticamente las políticas de salud indígena en Brasil y su concepto de “atención diferenciada”, que propone la articulación entre las prácticas oficiales de salud y las terapias indígenas. Varias contradicciones y tensiones están presentes entre la organización estructural del subsistema de salud indígena en el nivel nacional y las prácticas cotidianas de los equipos de salud en el nivel local. Guiados por la ideología hegemónica de la biomedicina, los profesionales de salud no reconocen las dinámicas y la agencia expresada en las practicas indígenas de salud.

Inde | Page 3 | CRDI - Centre de recherches pour le développement ...

International Development Research Centre (IDRC) Digital Library (Canada)

Read more about Know Violence in Childhood – Inde : Défense des droits, communication et mobilisation des médias. Langue French. Read more about Comprendre l'accès aux outils numériques et leur utilisation dans les pays du Sud. Langue French. Read more about Soutien technique aux projets pilotes de couverture ...

FDA toxicity databases and real-time data entry

International Nuclear Information System (INIS)

Arvidson, Kirk B.

2008-01-01

Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared

Análisis de la movilización indígena promovida por el consejo regional indígena del Cauca-(C.R.I.C), como herramienta política y social para la restitución de los derechos de los pueblos indígenas del departamento del Cauca, en el marco de la Minga Social y Comunitaria.(2006-2010)

OpenAIRE

Sánchez Ramírez, Catalina

2013-01-01

El análisis de este estudio se centra en describir el proceso que vivió la movilización indígena a través de la Minga de Resistencia Social y Comunitaria; que inició con diversas mingas a partir del año 2006 y se consolidó en el año 2009. Esta movilización tiene como fin exigir la restitución de los derechos de los pueblos indígenas del Departamento del Cauca. La Minga, se convierte en una herramienta política y social que a partir de la movilización empieza a estructurarse e involucrar a otr...

Automatic extraction of drug indications from FDA drug labels.

Science.gov (United States)

Khare, Ritu; Wei, Chih-Hsuan; Lu, Zhiyong

2014-01-01

Extracting computable indications, i.e. drug-disease treatment relationships, from narrative drug resources is the key for building a gold standard drug indication repository. The two steps to the extraction problem are disease named-entity recognition (NER) to identify disease mentions from a free-text description and disease classification to distinguish indications from other disease mentions in the description. While there exist many tools for disease NER, disease classification is mostly achieved through human annotations. For example, we recently resorted to human annotations to prepare a corpus, LabeledIn, capturing structured indications from the drug labels submitted to FDA by pharmaceutical companies. In this study, we present an automatic end-to-end framework to extract structured and normalized indications from FDA drug labels. In addition to automatic disease NER, a key component of our framework is a machine learning method that is trained on the LabeledIn corpus to classify the NER-computed disease mentions as "indication vs. non-indication." Through experiments with 500 drug labels, our end-to-end system delivered 86.3% F1-measure in drug indication extraction, with 17% improvement over baseline. Further analysis shows that the indication classifier delivers a performance comparable to human experts and that the remaining errors are mostly due to disease NER (more than 50%). Given its performance, we conclude that our end-to-end approach has the potential to significantly reduce human annotation costs.

Tuberculosis en la población indígena del Perú 2008 Tuberculosis in the indigenous population of Peru 2008

Directory of Open Access Journals (Sweden)

Dante R. Culqui

2010-03-01

Full Text Available Objetivos. Identificar a los pobladores indígenas afectados por tuberculosis (TB en el Perú durante el año 2008. Materiales y métodos. Estudio observacional, descriptivo, realizado de agosto a diciembre de 2009, que incluyó a los pacientes indígenas afectados por tuberculosis que ingresaron al programa durante el año 2008, de las 25 regiones del Perú; los cuales se presentan en tablas y gráficos elaborados en SPSS 16.0 y Excell 2007. Resultados. Se identificó a 702 indígenas con tuberculosis. El grupo étnico que presenta la mayor cantidad de pacientes con TB son los quechuas (417/702; 59,4%, los indígenas amazónicos (201/702; 28,6% de los cuales los grupos étnicos que presenta más del 60% de indígenas con TB, son los Ashaninka (Campas, Shipibo y Matsiguenga. En tercer lugar se encuentran los indígenas aymaras quienes presentaron (84/702; 11,97% de todos los pacientes diagnosticados con TB. Es importante mencionar que la distribución de los casos de tuberculosis multidrogoresistente involucra a cinco departamentos (nueve casos con TB MDR, siendo mayor el número de casos de TB MDR antes tratado 6/9, encontrándose sólo tres casos de TB MDR nuevos, pertenecientes al grupo indígena quechua. Conclusiones. Se han reportado altas tasas de incidencia en población indígena, lo que hace necesario investigaciones más profundas que garanticen la adecuada recolección de información por grupos étnicos a fin de contar con una evidencia de mayor jerarquía acerca de la situación de la tuberculosis en población indígena del Perú.Objective. To identify the indigenous inhabitants affected by tuberculosis (TB in Peru during the year 2008. Material and methods. Descriptive observational study, performed from August to December 2009, including all indigenous patients affected by tuberculosis that were including in the Control Program during the year 2008 in the 25 regions of Peru. Results. We identified 702 indigenous patients with

Pedagogização da literacy e alunos indígenas Guarani e Kaiowá de Dourados/MS

Directory of Open Access Journals (Sweden)

Marilda Moraes Garcia Bruno

Full Text Available Resumo Este trabalho objetiva discutir, a partir das contribuições de Brian Street, a pedagogização da literacy1 que ocorre entre os indígenas Guarani e Kaiowá da cidade de Dourados, no Mato Grosso do Sul. De abordagem etnográfica, com base nos Estudos Culturais, os dados da pesquisa foram coletados utilizando o instrumento da observação, da entrevista com 10 professores e de um conjunto de atividades pedagógicas realizadas com 08 alunos indígenas, com idade entre 12 a 15 anos. Os resultados do estudo apontam que o domínio da leitura e da escrita, além do conhecimento dos códigos ocidentais, tem sido sinônimo de sucesso profissional e acadêmico. Embora os alunos indígenas tenham um conhecimento tradicional, reconhecido a partir das histórias do seu povo, o que tem sido valorizado na escola é o código da escrita, que, ao não ser dominado, gera estigmas e preconceitos.

Emprendimientos productivos en grupos de mujeres indígenas: el caso de Talamanca

Directory of Open Access Journals (Sweden)

Ana Rosa Ruiz Fernández

2009-01-01

Full Text Available La pobreza es una condición que debe ser tratada desde la generación de capacidades y en especial, en lo productivo. El Programa de Equidad de Género del Instituto Tecnológico de Costa Rica, con una alianza estratégica con el Centro de Información Tecnológica, el Instituto de Estudios de la Mujer de la Universidad Nacional y Fundecooperación, está desarrollando una estrategia de generación de capacidades productivas en grupos de mujeres indígenas en Talamanca. Esta región y en general, los ocho pueblos indígenas que allí viven se han considerado de extrema pobreza y las mujeres tienen las más bajas posibilidades de educación por sus fuertes roles de reproducción y cuido. El proyecto inicia con tres grupos organizados de mujeres indígenas que están gestando proyectos productivos de turismo sostenible, una finca orgánica y reciclaje de desechos sólidos. Estos temas responden a una realidad de la zona: el desempleo y subempleo principalmente de las mujeres, deforestación, contaminación, problemas de salud y falta de oportunidades educativas. El objetivo final es crear una capacidad instalada y organizativa que promueva emprendimientos sostenibles y exitosos, especialmente entre las mujeres y su integración a redes nacionales de micro y pequeña empresas.

FDA regulations regarding iodine addition to foods and labeling of foods containing added iodine12

Science.gov (United States)

Trumbo, Paula R

2016-01-01

The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, “This salt does not supply iodide, a necessary nutrient.” If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine. PMID:27534626

Medical devices: reports of corrections and removals; delay of effective data--FDA. Direct final rule; delay of effective date.

Science.gov (United States)

1998-11-18

The Food and Drug Administration (FDA) published in the Federal Register of August 7, 1998 (63 FR 42229), a direct final rule. The direct final rule notified the public of FDA's intention to amend the regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. This document delays the effective date of the direct final rule.

FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR Staging

Science.gov (United States)

The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected.  The National Cancer In

Exact capture probability analysis of GSC receivers over i.n.d. Rayleigh fading channels

KAUST Repository

Nam, Sungsik; Yang, Hongchuan; Alouini, Mohamed-Slim; Kim, Dongin

2013-01-01

variates. With this motivation in mind, we first provide in this paper some new order statistics results in terms of both moment generating function (MGF) and probability density function (PDF) expressions under an i.n.d. assumption and then derive a new

Movimientos de base indígena y fase pre-constituyente de Bolivia (Tema Central)

OpenAIRE

Sandoval, Carla

2007-01-01

El presente artículo ofrece un panorama de la conformación de espacios de reflexión y diálogo abiertos por las organizaciones de base indígenas de los movimientos sociales de Bolivia durante el periodo Pre-constituyente.

Implantação de sistema de gestão ambiental em indústrias de embalagens de papel

OpenAIRE

Souza, Paulo Elias de

2013-01-01

Dissertação (mestrado) - Universidade Federal de Santa Catarina, Centro Tecnológico, Programa de Pós-Graduação em Engenharia Ambiental, Florianópolis, 2009 A necessidade das indústrias gerenciarem aspectos relacionados ao meio ambiente não é algo novo, pois o uso dos recursos naturais e a disposição dos resíduos da produção sempre ocorreram, desde a instalação das primeiras fábricas. Nas últimas décadas, entretanto, as indústrias começaram a modificar o estilo do seu gerenciamento ambienta...

Desigualdades de género en sobrepeso y obesidad entre indígenas chontales de Tabasco, México

OpenAIRE

Marcelina Cruz-Sánchez; Esperanza Tuñon-Pablos; Martha Villaseñor-Farías; Guadalupe del Carmen Álvarez-Gordillo; Ronald Nigh-Nielsen

2012-01-01

Antecedentes: La obesidad se ha convertido en una epidemia global (OMS) y, aunque se sabe que afecta por igual a toda la población, las mujeres aparecen con más obesidad y obesidad central. Se desconoce el porqué de este fenómeno, o si adquiere características específicas entre la población indígena. Objetivo: identificar las desigualdades de género que subyacen al fenómeno del cuerpo con sobrepeso y obesidad entre indígenas chontales de Tabasco. Materiales y métodos: estudio cualitativo con ...

Usos de la discursividad en los imaginarios simbólicos de la mujer indígena kichwa Chibuleo.

OpenAIRE

Ainaguano, Sisa Rosa; Bonilla Jami, Ana Lucía

2005-01-01

El presente trabajo investigativo está enmarcado en el contexto cultural y comunicativo, que bajo el tema “Usos de la Discursividad en los Imaginarios Simbólicos de la mujer indígena kichwa Chibuleo”, pretende conocer y analizar la riqueza de la Tradición Oral, como un sistema propio de comunicación de los pueblos indígenas, por ende constituye la raíz de su identidad. En la comunidad Chibuleo San Francisco, perteneciente al cantón Ambato y filial de la UNOPUCH (Unión de Organizaciones del Pu...

Migración y diferenciación étnica en Guatemala. Ser indígena en un contexto de globalización

Directory of Open Access Journals (Sweden)

Santiago Bastos

1999-01-01

Full Text Available En este artículo se discute si el concepto de la “desterritorialización de las identidades”, que se asocia a la globalización, es útil para describir la nueva relación que mantienen las poblaciones indígenas de Latinoamérica con el espacio, como efecto del proceso de “dispersión” que viven desde hace unas décadas. La comparación del proceso migratorio entre hogares indígenas y no indígenas que residen en tres espacios populares de la ciudad de Guatemala muestra algunas diferencias que permiten hablar de una “migración indígena” como proceso específico, marcado precisamente por su condición étnica. Entre estos elementos, se destacan el carácter familiar que toma el proceso y la vinculación que, tras el asentamiento en la ciudad, mantienen los hogares con sus lugares de origen, que siguen siendo la base simbólica de una identidad “transterritorial” y de comportamientos “holistas”.

Estado nutricional de crianças indígenas Guarani nos estados do Rio de Janeiro e São Paulo, Brasil

Directory of Open Access Journals (Sweden)

Carla Tatiana Garcia Barreto

2014-03-01

Full Text Available O presente estudo reporta os resultados de inquérito nutricional de crianças indígenas Guarani < 5 anos de idade nos estados do Rio de Janeiro e São Paulo, Brasil. As prevalências de desnutrição, segundo vários índices antropométricos foram de: 50,4% (baixa estatura para idade, 7,9% (baixo peso para idade e 0,8% (baixo peso para estatura. O déficit de estatura verificado na criança Guarani foi 96% maior do que nas crianças indígenas no Brasil (25,7% e 7,2 vezes do que o registrado nas crianças da população geral (7%. A prevalência de anemia foi de 65,2%, 3,1 vezes a prevalência correspondente nas crianças não indígenas (20,9%. Este estudo destaca elevadas prevalências de desnutrição crônica e anemia na criança Guarani, e põe em evidência as graves desigualdades em saúde e nutrição que afetam a criança indígena no país.

Estrategias de resistencia indígena frente al desarrollo minero: La comunidad de Likantatay ante un posible traslado forzoso

OpenAIRE

Carrasco, Anita; Fernández, Eduardo

2009-01-01

Este artículo revisa el complejo panorama que enfrenta la comunidad indígena atacameña de Likantatay ante las consecuencias de un proyecto de desarrollo minero que implican el traslado forzoso de dicha comunidad si este proyecto se concreta. Se analizan las estrategias de resistencia indígena que presenta y/o puede presentar la comunidad así como los discursos y estrategias ideológicas elaborados por la corporación minera para desarrollar los intereses del capital. El análisis se enmarca dent...

Association between change of health care providers and pregnancy exposure to FDA category C, D and X drugs.

Science.gov (United States)

Yang, Jianzhou; Xie, Rihua; Krewski, Daniel; Wang, Yongjin; Walker, Mark; Cao, Wenjun; Wen, Shi Wu

2014-01-01

Changing health care providers frequently breaks the continuity of care, which is associated with many health care problems. The purpose of this study was to examine the association between a change of health care providers and pregnancy exposure to FDA category C, D and X drugs. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 were chosen for this study. The association between the number of changes in health care providers and with pregnancy exposure to category C, D, and X drugs for those women with and without chronic diseases were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 568 women were included in this study. Rates of FDA C, D, and X drug uses were 14.35%, 17.07%, 21.72%, and 31.14%, in women with no change of provider, 1-2 changes, 3-5 changes, and more than 5 changes of health care providers. An association between the number of changes of health care providers and pregnancy exposure to FDA C, D, and X drugs existed in women without chronic diseases but not in women with chronic disease. Change of health care providers is associated with pregnancy exposure to FDA category C, D and X drugs in women without chronic diseases.

Los sistemas normativos indígenas en el marco del pluralismo jurídico. Un análisis desde los derechos indígenas = The right to the indigenous legal systems under the legal pluralism. An analysis from a right perspective

Directory of Open Access Journals (Sweden)

Asier Martínez de Bringas

2013-01-01

Full Text Available Este artículo se estructura en cuatro grandes momentos. Un primer momento, en donde establecer las condiciones para fijar el fundamento de un posible derecho a los que hemos llamado Sistemas Normativos Indígenas (SIN como referente fundamental para definir el Pluralismo Jurídico. Un segundo momento, en el que situar el concepto de justicia indígena en el discurso de los derechos humanos, teniendo en cuenta tanto referencias constitucionales de América Latina (Bolivia, Ecuador, Bolivia como del Sistema Internacional de derechos humanos. Es aquí en donde pondremos los SNI en conexión con una serie de principios básicos como son: el derecho a la cultura propia; el derecho a la autonomía; la necesaria coordinación entre jurisdicción indígena y estatal; el necesario vínculo de la justicia indígena con los derechos humanos; y el vínculo esencial entre el derecho indígena y sus tierras, territorios y recursos naturales. Un tercer momento en el que se establecen especificaciones y complementos al intento de fundamentar el derecho a los SNI, pero desde los pronunciamientos, informes, sentencias, ajustes jurídicos para entender los derechos de los pueblos indígenas, realizados por otros operadores jurídicos en el marco del espacio regional de protección de los derechos humanos: la OEA, y especialmente, a partir de intervenciones de la Corte y la Comisión Interamericana de derechos humanos, así como de referencias constitucionales latinoamericanas. Estos pronunciamientos e intervenciones funcionan como resortes jurídicos que complementan la construcción de un discurso jurídico de derechos humanos en relación a los pueblos indígenas, y muy especialmente, refuerzan el derecho a los SNI. This article is divide into four great moments. Initially, in which to establish the conditions to set the foundations for a possible right to Indigenous Legal Systems (ILS as a fundamental reference for defining Legal Pluralism. A second time

Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

Science.gov (United States)

2008-07-15

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

Conception de rues sûres et inclusives en Inde | CRDI - Centre de ...

International Development Research Centre (IDRC) Digital Library (Canada)

17 nov. 2016 ... ... alors que les cas de violence à l'égard des femmes sont en partie liés ... inégalités et violence en milieu urbain en Inde : vers un urbanisme plus inclusif. ... Comprendre les liens entre le genre, la vulnérabilité et la violence ...

The rise (and decline?) of biotechnology.

Science.gov (United States)

Kinch, Michael S

2014-11-01

Since the 1970s, biotechnology has been a key innovator in drug development. An analysis of FDA-approved therapeutics demonstrates pharmaceutical companies outpace biotechs in terms of new approvals but biotechnology companies are now responsible for earlier-stage activities (patents, INDs or clinical development). The number of biotechnology organizations that contributed to an FDA approval began declining in the 2000s and is at a level not seen since the 1980s. Whereas early biotechnology companies had a decade from first approval until acquisition, the average acquisition of a biotechnology company now occurs months before their first FDA approval. The number of hybrid organizations that arise when pharmaceutical companies acquire biotechnology is likewise declining, raising questions about the sustainability of biotechnology. Copyright © 2014 Elsevier Ltd. All rights reserved.

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

Science.gov (United States)

Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

2007-01-01

Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

Impactos da internet na indústria farmacêutica: novo modelo de negócios na economia da informação

OpenAIRE

Andrade, Marcelo Gelamos de

2010-01-01

Trata dos efeitos da Internet sobre as organizações, abordando as características da chamada Nova Economia da Informação. Focando a Indústria Farmacêutica, analisa os fundamentos que devem ser considerados pelas na revisão de seus modelos estratégicos e a proposição de um novo modelo de negócios para a Indústria Farmacêutica tomando em conta os impactos da Internet.

IND-2, a pyrimido[1″,2″:1,5]pyrazolo[3,4-b]quinoline derivative, circumvents multi-drug resistance and causes apoptosis in colon cancer cells.

Science.gov (United States)

Karthikeyan, Chandrabose; Lee, Crystal; Moore, Joshua; Mittal, Roopali; Suswam, Esther A; Abbott, Kodye L; Pondugula, Satyanarayana R; Manne, Upender; Narayanan, Narayanan K; Trivedi, Piyush; Tiwari, Amit K

2015-02-01

Naturally occurring condensed quinolines have anticancer properties. In efforts to find active analogues, we designed and synthesized eight polycyclic heterocycles with a pyrimido[1″,2″:1,5]pyrazolo[3,4-b]quinoline framework (IND series). The compounds were evaluated for activity against colon (HCT-116 and S1-MI-80), prostate (PC3 and DU-145), breast (MCF-7 and MDAMB-231), ovarian (ov2008 and A2780), and hepatocellular (HepG2) cancer cells and against non-cancerous Madin Darby canine kidney (MDCK), mouse embryonic fibroblast (NIH/3T3), and human embryonic kidney cells (HEK293). IND-2, a 4-chloro-2-methyl pyrimido[1″,2″:1,5]pyrazolo[3,4-b]quinoline, exhibited more than ten-fold selectivity and potent cytotoxic activity against colon cancer cells relative to the other cancer and non-cancer cells. With five additional colon cancer cell lines (HT-29, HCT-15, LS-180, LS-174, and LoVo), IND-2 had similar cytotoxicity and selectivity, and sub-micromolar concentrations caused changes in the morphology of HCT-116 and HCT-15 cells. IND-2 did not activate the transactivating function of the pregnane X receptor (PXR), indicating that it does not induce PXR-regulated ABCB1 or ABCG2 transporters. Indeed, IND-2 was not a substrate of ABCB1 or ABCG2, and it induced cytotoxicity in HEK293 cells overexpressing ABCB1 or ABCG2 to the same extent as in normal HEK293 cells. IND-2 was cytotoxic to resistant colon carcinoma S1-MI-80 cells, approximately three- and five-fold more than SN-38 and topotecan, respectively. In HCT-116 colon cancer cells, IND-2 produced concentration-dependent changes in mitochondrial membrane potential, leading to apoptosis, and sub-micromolar concentrations caused chromosomal DNA fragmentation. These findings suggest that, by increasing apoptosis, IND-2 has potential therapeutic efficacy for colorectal cancer. Copyright © 2014 Elsevier Ltd. All rights reserved.

Entre el proceso constituyente y la revolución ciudadana: el movimiento indígena ecuatoriano en la encrucijada

Directory of Open Access Journals (Sweden)

Emma Martín Díaz

2015-10-01

Full Text Available El movimiento indígena ecuatoriano constituye un referente paradigmático de la lucha de los pueblos originarios y las culturas ancestrales a escala global. Una prueba de su importancia es la Constitución de 2088, que define al Estado como plurinacional e intercultural.Esta definición supone el reconocimiento de los pueblos indígenas como nuevos sujetos sociales, y una reformulación del modelo de ciudadanía. Sin embargo, cinco años después del Proceso Constituyente, el movimiento indígena se encuentra sumido en una importante crisis. Este trabajo se centra en el análisis de las causas que determinan la crisis actual, y en particular en las políticas que desde el gobierno y desde el movimiento político Alianza PAIS tienen como objetivo la desactivación del movimiento indígena, la deslegitimación de sus líderes y la pérdida de la autonomía territorial, así como en las estrategias desplegadas por el propio movimiento para hacer frente a esta agresión.Palabras clave: pueblos indígenas, plurinacionalidad, interculturalidad, movimientos sociales, Ecuador.________________Abstract: The indigenous movement of Ecuador has been a shining example of the battle of original peoples and ancestral cultures on a global scale. The most relevant of their achievements was the definition of Ecuador as an intercultural and plurinational State, incorporated in the 2008 Constitution. This definition entails the recognition of indigenous peoples as new social subjects. However, five years before the new Constitution, the indigenous move-ment is submerged in a deep crisis. On the one hand, this paper is aimed to throw new light on the governmental policies directed to under-mine the indigenous movement and to delegitimize their leaders, and, on the other, it is focused on the strategies of the movement to confront the present situation.Keywords: indigenous peoples, plurinationality, interculturality, social movements, Ecuador.

Editorial: Anastasia Candre y otros creadores indígenas

Directory of Open Access Journals (Sweden)

Juan Alvaro Echeverri

2014-09-01

Full Text Available Presentación de la trayectoria personal e intelectual de Anastasia Candre, presentación del contenido de los tres dossiers de la revista (Anastasia Candre, Mira - Artes Visuales Contemporáneas de los Pueblos Indígenas, e Investigación Propia, discusión de la riqueza lingüistica y expresiva de estos textos y de su aporte como formas alternativas de conocimiento y expresión. Concluye con unas palabras en memoria de Roberto Franco García y Daniel Matapí, fallecidos en septiembre de 2014 en un accidente aéreo.

A Phase 2 Trial on the Effect of Low-Dose Versus High-Dose Vitamin D Supplementation on Bone Mass in Adults with Neurofibromatosis 1 (NF1)

Science.gov (United States)

2015-10-01

versus High-Dose Vitamin D Supplementation on Bone Mass in Adults with Neurofibromatosis 1 (NF1) 5a. CONTRACT NUMBER 5b. GRANT NUMBER W81XWH-12-1...regulatory processes have taken more time than anticipated in the Statement of Work. An IND from the FDA to use high-dose vitamin D in the NF1

The Emergence of Inclusive Exploratory Talk in Primary Students' Peer Interaction

Science.gov (United States)

Rajala, Antti; Hilppo, Jaakko; Lipponen, Lasse

2012-01-01

In this study, we examine a prominent type of classroom talk, exploratory talk, in primary school peer interactions. Exploratory talk has been shown to be productive in facilitating problem solving and fostering school achievement. However, within the growing body of research concerning exploratory talk, the relation between exploratory talk and…

Indígenas urbanos y derechos culturales: los límites del multiculturalismo liberal Urban indians and cultural rights: the limits of multicultural liberalism

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Daniel Bonilla Maldonado

2011-12-01

Full Text Available En este artículo se evalúan los límites del multiculturalismo liberal para describir y evaluar la realidad de los indígenas contemporáneos. El liberalismo multicultural llena de contenido la identidad indígena haciendo uso de las siguientes cinco categorías: territorio Ancestral, territorio rural, naturaleza salvaje, prácticas culturales atávicas y economía de subsistencia. Esta forma de entender la identidad indígena, además, es la base para sustentar quiénes son titulares legítimos de los derechos culturales compatibles con el liberalismo. Sin embargo, esta descripción de la identidad indígena choca con la realidad de buena parte de los indígenas contemporáneos. La realidad de una parte muy importante de estos individuos y colectividades está estrechamente relacionada com contextos urbanos que están fuera de sus territorios ancestrales. En México, por ejemplo, aproximadamente el 30% de los indígenas vive en ciudades, en Canadá lo hace el 50 % y en Australia el 75%. Hoy en día, el 61% de los indígenas estadounidenses y el 21% de los colombianos habitan en zonas urbanas. Los indígenas contemporáneos son, en buena parte, indígenas urbanos que forman parte de la economía de mercado. No obstante, el liberalismo multicultural, con sus categorías descriptivas y normativas, no tiene la posibilidad de reconocerlos y acomodarlos apropiadamente en la comunidad política.In this article, i assess the limits of liberal multiculturalism to describe and evaluate the reality of contemporary indians. Liberal multiculturalism structures indian identity appealing to the following five categories: ancestral territory, rural territory, wild nature, atavic cultural practices, and subsistence economy. This way of understanding indian identity, moreover, is the basis to justify who is entitled to the cultural rights that are compatible with liberalism. However, this description of indian identity collides with the reality of a great

EL IMAGINARIO DE UNA NACIÓN PLURALISTA: los intelectuales públicos y la jurisdicción especial indígena en Colombia

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JOANNE RAPPAPORT

2003-01-01

Full Text Available LA CONSTITUCIÓN DE 1991 LE DA DERECHO A LAS COMUNIDADES INDÍGENAS A TENER un sistema legal basado en sus propios "usos y costumbres". El artículo explora el papel de los intelectuales indígenas en la reconstrucción del derecho consuetudinario, indagando cómo han interpretado los activistas indígenas el pluralismo legal al analizar el significado de los neologismos creados al traducir la constitución al idioma nasa. Luego analiza un caso legal en el que los derechos constitucionales de ciertos individuos como ciudadanos colombianos entran en conflicto con los derechos de las comunidades indígenas -recientemente reconocidos- como actores legales colectivos, tratando de entender los múltiples niveles en los que debe negociarse el pluralismo legal.

El Programa de Apoyo a Estudiantes Indígenas en Instituciones de Educación Superior. Alcances, retos e impactos

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Jessica Badillo Guzmán

2011-01-01

Full Text Available El Programa de Apoyo a Estudiantes Indígenas en Instituciones de Educación Superior (paeiies es una iniciativa de base étnica implementada en México a partir del año 2001 con financiamiento de la Fundación Ford. En este artículo se presenta un análisis del Programa a partir de un estudio con egresados indígenas de dos universidades, que estuvieron adscritos a éste, desde la perspectiva de las teorías de justicia distributiva y la sociología de la desigualdad. En primer lugar, se revisa el panorama de iniciativas de base étnica en México, posteriormente, se analiza el surgimiento y los alcances institucionales del paeiies. Por último, se presentan los impactos que el Programa tuvo en los egresados indígenas en tres ámbitos, sus trayectorias escolares, la relación con sus comunidades y su inserción al mercado laboral.

La etnicidad cuestionada: Ancestralidad en las hijas e hijos de inmigrantes indígenas oaxaqueños en Estados Unidos

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María Eugenia HERNÁNDEZ MORALES

2015-01-01

Full Text Available Este artículo analiza el dilema identitario y de pertenencia en los hijos de inmi-grantes indígenas oaxaqueños en Estados Unidos, a través del estudio de tres di-mensiones de la ancestralidad: el lugar de origen, la vida comunitaria y la lengua indígena. El artículo documenta distintos cursos del proceso de etnización entre jóvenes de origen mixteco, zapoteco y triqui, nacidos o crecidos en Estados Unidos; metodológicamente se basa en tres talleres con activistas del Frente Indígena de Organizaciones Binacionales (FIOB y en veinte entrevistas en profundidad. Los ha-llazgos muestran que cada una de las dimensiones analizadas tiene un papel distinto en la construcción identitaria de acuerdo con ciertos factores como la escolaridad, el aprendizaje del idioma inglés y la participación política o comunitaria de estos jóvenes.

A indústria de fertilizantes químicos no Brasil

OpenAIRE

Telles, Adalberto Franco Netto

2014-01-01

O presente estudo trata do desenvolvimento da Indústria de Fertilizantes Químicos no Brasil, especialmente a partir de 1950. Analisa neste período os condicionantes do crescimento da oferta de fertilizantes e de sua demanda. A ênfase dada, no tocante à oferta nacional de fertilizantes, recai sobre a estrutura industrial originada com a implantação do Programa Nacional de Fertilizantes e Calcário Agrícola, subprograma do II Plano Nacional de Desenvolvimento, e seu ajustamento à crise setorial ...

En rejse ind i dental biofilm

DEFF Research Database (Denmark)

Schlafer, Sebastian

Som klinkassistent og tandplejer arbejder man hver dag med bakteriel biofilm på tandoverfladerne – plak. Alle ved udmærket, at denne biofilm er ansvarlig for mundhulens hyppigste sygdomme, caries og parodontitis. Vi renser patienternes tænder for biofilm og opfordrer dem til at fjerne biofilmen...... mindst to gange om dagen, så grundigt de kan. Desuden bruges der en lang række antibakterielle tilsætningsstoffer i både tandpasta og mundskyllevæsker, hvis hovedformål er at dræbe bakterierne i dental biofilm. Men er biofilmen virkelig kun farlig? Nyere forskning har vist, at mennesket faktisk i høj...... grad er afhængig af de bakterier, der koloniserer kroppen. Hvorfor gælder dette tilsyneladende ikke for mundhulen? I løbet af præsentationen vil jeg tage tilhørerne med på en rejse ind i dental biofilm. Jeg vil belyse den komplekse bakterielle arkitektur, som kendetegner biofilmen, og vil analysere de...

Infestación por triatominos en comunidades indígenas de Valledupar, Colombia

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Marleny Montilla

2011-08-01

Full Text Available OBJETIVO: Calcular los índices infestación por triatominos en comunidades indígenas en Colombia. MÉTODOS: Se realizó estudio descriptivo en 19 comunidades indígenas del municipio de Valledupar Departamento de Cesar, Colombia. Durante junio a diciembre de 2007 se recolectaron triatominos por búsqueda activa en las viviendas de los indígenas. Los insectos luego fueron identificados por las claves de Lent & Wygodzinsky. Se desarrolló estudio del proceso infectivo en modelo animal y análisis enzimático de cepas de Trypanosoma cruzi, detectadas en heces de triatominos. RESULTADOS: Rhodnius prolixus presentó índice de densidad en las viviendas de 154,7%, Triatoma dimidiata de 102,45%, Triatoma maculata de 109,25% y Panstrogylus geniculatus de 0,3%. El índice promedio de infestación de las cuatro especies fue de 40,54% y, el de infección con T. cruzi de 9,4%. De cinco hemocultivos positivos para T. cruzi, tres se caracterizaron por isoenzimas, clasificándose en T. cruzi grupo I. El estudio de las biopsias reveló pocas características patológicas durante el proceso de infección con las cepas de T. cruzi aisladas de triatominos domiciliados. CONCLUSIÓN: Los altos índices de infestación por triatominos en las viviendas y el índice de infección por T. cruzi, evidencian la transmisión activa de la enfermedad de Chagas, situación que amerita la aplicación de medidas de control vectorial y el estudio seroepidemilógico de la población en riesgo. La identificación de las cepas de T. cruzi como grupo I concuerda con otros estudios realizados en esta región colombiana.

Análise das Mudanças no Número de Ocupados na Indústria Agroalimentar Brasileira

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Pablo Murta Baião Albino

2016-03-01

Full Text Available Resumo: A partir da constatação da importância da indústria agroalimentar (IAA brasileira como geradora de emprego, o presente trabalho analisou a variação no número de pessoas ocupadas nesta indústria no período de 1996 a 2012. Mediante a análise shift share (SSA foram verificados quais efeitos são os responsáveis pelas mudanças no número de ocupados. Os efeitos utilizados no trabalho provêm das versões mais modernas e completas da SSA, de modo que foram analisados os efeitos nacional, estrutural, competitivo de mercado e competitivo de especialização, bem como a decomposição homotética e residual de cada um desses. O trabalho levou em consideração as regiões Sul e Sudeste, com exceção do Espírito Santo. Ao mesmo tempo, a base de dados também foi segmentada de acordo com os setores de atividades que formam a IAA. Os resultados encontrados indicam que o número de ocupados da IAA variou devido ao efeito nacional, ou seja, seguiu a corrente da indústria nacional, sem apresentar qualquer diferencial na sua estrutura ou na sua estratégia competitiva que pudesse ser identificada nesta análise.

O circuito rap “indé” em Paris: dinâmicas socioterritoriais e mensagem ultramar

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Cristiano Nunes Alves

2016-05-01

Full Text Available Aborda-se o circuito rap independente em Paris, o chamado “rap indé”, produção musical da cultura hip hop, constituída por materialidades e fluxos dinamizados por agentes cujas raízes estão em territórios ultramarinos. Lançando mão de um levantamento documental e bibliográfico, e, de uma série de entrevistas e visitas técnicas, problematiza-se a relação do hip hop com o lugar, e propõe-se uma análise do rap indé a partir da teoria dos circuitos da economia urbana nos países subdesenvolvidos. Observa-se que o circuito indé, fortalecido na Île-de-France, sobretudo desde meados dos anos 1990, mobiliza toda a região, tendo em Clignancourt, importante lugar de encontro e articulação.  Sua produção dá-se em estúdios e selos de menor porte, caracterizando-se ainda por pequenas espessuras ligadas aos eventos musicais, e, divulgação e comercialização alternativas aos grandes circuitos da economia. Trata-se de um estudo buscando alternativas para pensar os modos de se analisar, a partir da música, as dinâmicas socioterritoriais na cidade contemporânea.

Mapeamento de conhecimento na plataforma Scopus: um estudo sobre a indústria criativa

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Cristiano Max Pereira Pinheiro

2015-05-01

Full Text Available Buscando destacar o momento oportuno à compreensão do tema, este trabalho visa apresentar um mapeamento da produção científica no domínio da Indústria Criativa, através de uma proposta de mineração de textos científicos na base de dados Scopus, fundamentada em métodos bibliométricos. Para o desenvolvimento teórico da pesquisa, são utilizados autores como Howkins (2002, Deheinzelin (2011, Reis (2012, Prodanov e Freitas (2013, Hauenstein (2008, Vanti (2006, M. Hayashi, Faria e C. Hayashi (2013. Ao fim do estudo, destaca-se que, através dos critérios estabelecidos, o levantamento realizado apontou 933 publicações na área de Indústria Criativa. Ressalta-se, ainda, outros resultados quantitativos, analisados seguindo categorias com maior número de publicações, como: ano (2013, periódico (International Journal of Cultural Policy, autor (C. Gibson, instituição de ensino (Queensland University, país (Reino Unido e área de assunto (Ciências Sociais.

Autobiografia e sujeito histórico indígena: considerações preliminares

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Oscar Calavia Sáez

2006-11-01

Full Text Available A autobiografia, gênero central na bibliografia escrita por ou sobre indígenas nos Estados Unidos, está ausente na bibliografia equivalente no Brasil. Este trabalho questiona as razões desse contraste, resumindo análises sobre a peculiaridade cultural do gênero autobiográfico - profundamente vinculado à formação do indivíduo ocidental -, sobre sua possível tradução ameríndia e sobre as formas pelas quais o sujeito histórico indígena tem sido construído no Brasil.Autobiography, widely present in bibliography written by or about the indigenous people in the US, is seldom found in equivalent texts produced in Brazil. This article raises and discusses reasons for this contrast. It brings to light problems involving cultural peculiarities of the autobiographic genre - profoundly connected to the formation of the occidental individual -, the possibilities of its Amerindian translation and the specific aspects by which the historical indigenous subject has been constructed in Brazil.

Prevalencia de diabetes mellitus e hiperlipidemias en indígenas otomíes

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Alvarado-Osuna Claudia

2001-01-01

Full Text Available Objetivo. Determinar prevalencia y factores de riesgo de la diabetes mellitus (DM e hiperlipidemias en un grupo de indígenas otomíes de Querétaro. Material y métodos. Entre 1996 y 1997, en muestreo de conveniencia se trabajó con 91 indígenas, de 15 a 77 años de edad, de las comunidades de Yosphí y El Rincón, del estado de Querétaro, México. Se tomaron muestras sanguíneas en ayuno y se determinó la concentración de glucosa, colesterol y triglicéridos. Se realizó análisis estadístico para comparación entre sexos y grupos de edad. Resultados. La prevalencia de DM fue 4.4%, la de hipercolesterolemia 7.2%, y la de hipertrigliceridemia (HTG 26%. Las concentraciones promedio de glucosa (81.0±24.4 mg/dl y triglicéridos (157.4±88.9 mg/dl se incrementaron significativamente con la edad (p=0.0279 y phttp://www.insp.mx/salud/index.html

The inflammatory & neurodegenerative (I&ND) hypothesis of depression: leads for future research and new drug developments in depression.

Science.gov (United States)

Maes, Michael; Yirmyia, Raz; Noraberg, Jens; Brene, Stefan; Hibbeln, Joe; Perini, Giulia; Kubera, Marta; Bob, Petr; Lerer, Bernard; Maj, Mario

2009-03-01

Despite extensive research, the current theories on serotonergic dysfunctions and cortisol hypersecretion do not provide sufficient explanations for the nature of depression. Rational treatments aimed at causal factors of depression are not available yet. With the currently available antidepressant drugs, which mainly target serotonin, less than two thirds of depressed patients achieve remission. There is now evidence that inflammatory and neurodegenerative (I&ND) processes play an important role in depression and that enhanced neurodegeneration in depression may-at least partly-be caused by inflammatory processes. Multiple inflammatory-cytokines, oxygen radical damage, tryptophan catabolites-and neurodegenerative biomarkers have been established in patients with depression and these findings are corroborated by animal models of depression. A number of vulnerability factors may predispose towards depression by enhancing inflammatory reactions, e.g. lower peptidase activities (dipeptidyl-peptidase IV, DPP IV), lower omega-3 polyunsaturated levels and an increased gut permeability (leaky gut). The cytokine hypothesis considers that external, e.g. psychosocial stressors, and internal stressors, e.g. organic inflammatory disorders or conditions, such as the postpartum period, may trigger depression via inflammatory processes. Most if not all antidepressants have specific anti-inflammatory effects, while restoration of decreased neurogenesis, which may be induced by inflammatory processes, may be related to the therapeutic efficacy of antidepressant treatments. Future research to disentangle the complex etiology of depression calls for a powerful paradigm shift, i.e. by means of a high throughput-high quality screening, including functional genetics and genotyping microarrays; established and novel animal and ex vivo-in vitro models for depression, such as new transgenic mouse models and endophenotype-based animal models, specific cell lines, in vivo and ex vivo

Terminología botánica indígena en el vocabulario castellanomexicano (1555 de Fray A. De Molina

Directory of Open Access Journals (Sweden)

Manuel Galeote

2002-01-01

Full Text Available Las voces indígenas de la flora americana, que fray Alonso de Molina incluye en la sección castellana de su obra: Aqui comiença vn vocabulario en la lengua castellana y mexicana (México, Juan Pablos, 1555 se analizan desde el punto de vista histórico y sociolingüístico. Se trata del primer vocabulario de Molina —el Nebrija de las Indias — y, además, el primer diccionario impreso en México y en América. En las entradas castellanas, los términos indígenas americanos de la flora (plantas y frutas constituyen uno de los campos onomasiológicos más numerosos (maíz, cacao, maguey, chía, ají, etc. De los once términos indígenas hemos contabilizado casi un centenar de ocurrencias. En conclusión, este vocabulario muestra el fondo léxico patrimonial del español y los indoamericanismos que se acomodaron a las estructuras de la lengua castellana.

Lenguas y participación comunitaria en la educación indígena en México

Directory of Open Access Journals (Sweden)

Bruno Baronnet

2013-05-01

Full Text Available Este artículo aporta elementos de análisis antropológico para el estudio de las estrategias de los pueblos indígenas ante la enseñanza de las lenguas originarias en la escuela primaria en México. Se enfatiza el contraste entre un contexto multiétnico en el cual predomina una incidencia relativamente débil de las autoridades y las familias indígenas en la gestión administrativa y curricular, como en las colonias que cuentan con nuevas escuelas de educación indígena en Morelos, y otro contexto de participación más activa y amplia de los actores comunitarios en la educación, como en los municipios autónomos zapatistas de Chiapas. Al poner en perspectiva las experiencias de comunidades tzeltales, como en el caso de la Selva Lacandona, con las prácticas de actores nahuas en pueblos relativamente subordinados a las políticas estatales, se observa una mayor disposición por valorar las lenguas originarias en las aulas a medida que el marco de gestión educativa permite mayor participación de las familias en los planes y programas de estudio.

Conceptos indígenas de la formación territorial y Etno-Político frente al Estado Republicano-Nacional

OpenAIRE

Fischer, Eva

2003-01-01

Presentación La multiculturalidad de la Ciudad de México y los Derechos Indígenas Oehmichen, Cristina Conceptos indígenas de la formación territorial y Etno-Político frente al Estado Republicano-Nacional Fischer, Eva Disputas matrimoniales y cambio social en Coyutla, Veracruz (México) Chenaut, Victoria El debate indio sobre la ciudadanía multicultural en México: La revuelta por la dignidad Valladares de la Cruz, Laura Análisis de las actitudes de políticos criollos ...

Innovations issues de la base en Chine et en Inde | CRDI - Centre ...

International Development Research Centre (IDRC) Digital Library (Canada)

Les innovations issues de la base sont celles qui émergent des systèmes de connaissances traditionnels et officieux d'un lieu, qu'on intègre ou non un savoir officiel. En Chine et en Inde, on n'a pas encore pleinement compris et mis à profit ce type d'innovation. Cette subvention financera une étude approfondie de ce type ...

A dimensão do embeddedness na indústria do vinho: um estudo comparado entre Brasil e Chile

Directory of Open Access Journals (Sweden)

Marlon Vinícius Brisola

2010-07-01

Full Text Available O conceito de embeddedness toma ênfase nos discursos das ciências sociais, no âmbito da sociologia econômica, na última década. Neste contexto, as discussões sobre o comportamento dos agentes participantes de uma relação de troca tomam maior importância e revelam a necessidade de uma maior compreensão das instituições que compõem uma estrutura de mercado. Com base nesta prerrogativa, o artigo discute o imbricamento entre a sociologia e a economia nas relações de troca na indústria do vinho, numa dimensão comparada entre Brasil e Chile. Desta forma, são descritos aspectos que revelam as particularidades dessa indústria, tal como o efeito terroir e as influências da marca, aroma e sabor no contexto mercadológico dos vinhos. Como resultado da análise comparativa, verifica-se elementos institucionais no campo das políticas públicas que descrevem uma maior participação do Estado chileno, em detrimento do brasileiro, no estímulo ao desenvolvimento dessa indústria.

The Exploratory Modeling Workbench : An open source toolkit for exploratory modeling, scenario discovery, and (multi-objective) robust decision making

NARCIS (Netherlands)

Kwakkel, J.H.

2017-01-01

There is a growing interest in model-based decision support under deep uncertainty, reflected in a variety of approaches being put forward in the literature. A key idea shared among these is the use of models for exploratory rather than predictive purposes. Exploratory modeling aims at exploring

New FDA-Approved Disease-Modifying Therapies for Multiple Sclerosis.

Science.gov (United States)

English, Clayton; Aloi, Joseph J

2015-04-01

Interferon injectables and glatiramer acetate have served as the primary disease-modifying treatments for multiple sclerosis (MS) since their introduction in the 1990s and are first-line treatments for relapsing-remitting forms of MS (RRMS). Many new drug therapies were launched since early 2010, expanding the drug treatment options considerably in a disease state that once had a limited treatment portfolio. The purpose of this review is to critically evaluate the safety profile and efficacy data of disease-modifying agents for MS approved by the US Food and Drug Administration (FDA) from 2010 to the present and provide cost and available pharmacoeconomic data about each new treatment. Peer-reviewed clinical trials, pharmacoeconomic studies, and relevant pharmacokinetic/pharmacologic studies were identified from MEDLINE (January 2000-December 2014) by using the search terms multiple sclerosis, fingolimod, teriflunomide, alemtuzumab, dimethyl fumarate, pegylated interferon, peginterferon beta-1a, glatiramer 3 times weekly, and pharmacoeconomics. Citations from available articles were also reviewed for additional references. The databases publically available at www.clinicaltrials.gov and www.fda.gov were searched for unpublished studies or studies currently in progress. A total of 5 new agents and 1 new dosage formulation were approved by the FDA for the treatment of RRMS since 2010. Peginterferon beta-1a and high-dose glatiramer acetate represent 2 new effective injectable options for MS that reduce burden of administration seen with traditional interferon and low-dose glatiramer acetate. Fingolimod, teriflunomide, and dimethyl fumarate represent new oral agents available for MS, and their efficacy in reducing annualized relapse rates is 48% to 55%, 22% to 36.3%, and 44% to 53%, respectively, compared with placebo. Alemtuzumab is a biologic given over a 2-year span that reduced annualized relapse rates by 55% in treatment-naive patients and by 49% in patients

L'intégration des plantes médicinales en Inde | IDRC - International ...

International Development Research Centre (IDRC) Digital Library (Canada)

3 févr. 2011 ... Un nouveau programme lancé par le gouvernement de l'Inde pour intégrer les plantes médicinales aux pratiques médicales traditionnelles et aux moyens de subsistance habituels pourrait être une source de revenus pour les villageois qui en font la cueillette et rendre leur utilisation plus sécuritaire.

Exploratory research and development FY90

International Nuclear Information System (INIS)

Struble, G.L.; Middleton, C.; Baldwin, G.; Cherniak, J.; Clements, W.; Donohue, M.L.; Francke, A.; Kirvel, R.D.; MacGregor, P.; Shaw, G.

1990-01-01

In general, the Exploratory Research and Development (ER ampersand D) Program supports research projects considered too basic or long-range to be funded by other Lawrence Livermore National Laboratory (LLNL) programs. This Program is managed for the Laboratory Director by a special assistant who chairs the LLNL's IR ampersand D Review Committee. Membership in the Review Committee comprises senior LLNL scientists, engineers, and managers whose areas of expertise span the range of scientific disciplines pursued at the Laboratory. The research supported by the Program falls into three categories: Exploratory Research in the Disciplines, Director's Initiatives, and Laboratory-Wide Competition. The first two, Exploratory Research and Director's Initiatives, promote pioneering work in the various scientific disciplines and programmatic areas. Laboratory departments and divisions propose and manage projects in the Exploratory Research category. The Laboratory Director, with the advice of the Review Committee, selects several larger projects to fund as Director's Initiative. These projects, which are proposed and managed by the responsible associate director, are intended to enhance the scope of existing programs or establish new technical directions and programs for the Laboratory. All FY90 projects are described in detail in this report. Other publications on ER ampersand D projects are included in the Publications List at the back of this report

Conversações desassossegadas: diálogos sobre coleções etnográficas com o povo indígena Ka’apor

Directory of Open Access Journals (Sweden)

Claudia Leonor López Garcés

Full Text Available Resumo Este artigo trata do processo de diálogo sobre coleções etnográficas de objetos Ka’apor e da curadoria compartilhada da exposição “A Festa do Cauim”, atividades promovidas pelo Museu Nacional de Etnologia de Leiden (NME, Holanda, junto ao Museu Paraense Emílio Goeldi (MPEG, Brasil, e o povo indígena Ka’apor da Terra Indígena Alto Turiaçu, localizada no estado de Maranhão, na Amazônia brasileira. É reflexo de uma mudança de filosofia no NME em direção a uma atividade mais inclusiva e colaborativa, como também dos processos de atuação com povos indígenas promovidos no Museu Goeldi e da necessidade política dos Ka’apor de chamar atenção, em nível nacional e internacional, para a defesa de seus direitos territoriais, continuamente ameaçados por atores envolvidos com a exploração ilegal de madeira no seu território. Considerando diferentes enfoques disciplinares, principalmente da antropologia e da museologia, em consonância com o pensamento indígena, assim como com as negociações de interesses e encontro de diversas perspectivas cognitivas e posicionamentos políticos, este artigo, além de documentar e refletir sobre a produção cocriativa de uma exposição etnográfica, procura repensar as dimensões cognitiva, política e ética deste tipo de trabalho com povos indígenas.

Las familias indígenas de Santafé, Nuevo Reino de Granada, según los testamentos de los siglos XVI y XVII

Directory of Open Access Journals (Sweden)

Sandra Turbay Ceballos

2012-01-01

Full Text Available El análisis de 89 testamentos indígenas de Santafé, capital del Nuevo Reino de Granada, de los siglos XVI y XVII, da cuenta de las transformaciones de la familia muisca en la ciudad colonial. Desapareció la poliginia y el precio de la novia, y se legitimó el matrimonio a través del sacramento católico; se instauró la costumbre de la dote mediterránea y los hijos empezaron a heredar los bienes de su padre. Sin embargo, los testamentos demuestran la persistencia de algunos rasgos matrilineales en los legados que los hombres dejaban a los hijos de sus hermanas y en la sucesión de los cacicazgos. La migración masiva de indígenas a la nueva ciudad promovió el mestizaje y la reconfiguración de las familias indígenas que acogieron en su seno a huérfanos de diferente condición. Algunas mujeres alcanzaron posiciones inéditas y recurrieron a la Real Audiencia para defender los derechos que creían conculcados por sus maridos indígenas o por los padres españoles de sus hijos.

Når HRM sparker døren ind til fremtiden

DEFF Research Database (Denmark)

Holt Larsen, Henrik

2016-01-01

Vi er alt for beskedne of uambitiøse, når vi siger, hvad HRM kan bidrage med i fremtidens virksomheder. Mange af de generelle udfordringer, som virksomhederne står overfor, har nemlig en karakter, der gør det naturligt eller nødvendigt at sætte ind med HRM-professionalisme. Bolden ligger for vores...... fødder, så nu gælder det bare om at sparke. Artiklen beskriver nogle af de vigtigste udfordringer - og hvorfor HRM er et svar herpå....

Awareness and trust of the FDA and CDC: Results from a national sample of US adults and adolescents.

Directory of Open Access Journals (Sweden)

Sarah D Kowitt

Full Text Available Trust in government agencies plays a key role in advancing these organizations' agendas, influencing behaviors, and effectively implementing policies. However, few studies have examined the extent to which individuals are aware of and trust the leading United States agencies devoted to protecting the public's health. Using two national samples of adolescents (N = 1,125 and adults (N = 5,014, we examined demographic factors, with a focus on vulnerable groups, as correlates of awareness of and trust in the Centers for Disease Control and Prevention (CDC, Food and Drug Administration (FDA, and the federal government. From nine different weighted and adjusted logistic regression models, we found high levels of awareness of the existence of the FDA and CDC (ranging from 55.7% for adolescents' awareness of the CDC to 94.3% for adults' awareness of the FDA and moderate levels of trust (ranging from a low of 41.8% for adults' trust in the federal government and a high of 78.8% for adolescents' trust of the FDA. In the adolescent and adult samples, awareness was higher among non-Hispanic Blacks and respondents with low numeracy. With respect to trust, few consistent demographic differences emerged. Our findings provide novel insights regarding awareness and trust in the federal government and specific United States public health agencies. Our findings suggest groups to whom these agencies may want to selectively communicate to enhance trust and thus facilitate their communication and regulatory agendas.

FDA-approved drugs that are spermatotoxic in animals and the utility of animal testing for human risk prediction.

Science.gov (United States)

Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo

2018-02-01

This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.

"Sin música no hay fiesta, no hay nada": aproximaciones a las expresiones musicales indígenas en Chiapas

OpenAIRE

Marina Alonso Bolaños

2012-01-01

Desde un enfoque antropológico del arte y la estética, en este artículo se exploran las posibilidades para abordar aspectos de la constitución de las expresiones musicales indígenas contemporáneas del estado del Chiapas, en el sureste de México. Se discuten también, las perspectivas indígenas acerca de los procesos de creación musical (interpretación y transmisión-aprendizaje), el papel de los instrumentos musicales y en la audiencia, así como la coexistencia de los distintos estilos y formas...

Trenching as a exploratory method

International Nuclear Information System (INIS)

Hatheway, A.W.; Leighton, F.B.

1979-01-01

The critical nature of siting nuclear power plants has led to increased emphasis on exploratory methods; it permits inspection of a continuous geologic section by both geologists and regulatory authorities and makes possible the preparation of a graphic log that delineates both obvious and subtle geologic features. About one of every two nuclear plant licensing efforts utilizes exploratory trenching. Many geologic hazards, such as ''capable'' faults, can be detected from trench exposures; they may otherwise remain undetected. Trenches must be judiciously located, survey-controlled, excavated safetly and adequately shored, logged in detail, and properly diagnosed. Useful techniques of trench logging include thorough cleaning of the trench walls, teamwork between geologist and recorder, logging against a carefully surveyed baseline and vertical reference grid, and panoramic photography. Soils, including paleosols, and glacial and glaciofluvial deposits present some of the most difficult media to log. Trench logs must be thoroughly interpreted and correlated so that they document the geologic conditions governing suitability of the site. Age-determination techniques utilized in exploratory trenching include petrographic analyses, quartz inclusion studies, clay mineralogic analyses, and radiometric methods

El arte indígena americano en los museos españoles. Propuesta de acción didáctica

OpenAIRE

Muñoz García, Gemma María

2015-01-01

La presente investigación se desarrolla desde un punto de vista multidisciplinar, abarcando ámbitos como: la Antropología, las manifestaciones artísticas indígenas de América, la Museología, la Comunicación, la Didáctica de las Ciencias Sociales, las Nuevas Tecnologías, pero principalmente la Educación Patrimonial. Nuestro principal objetivo e hipótesis de partida, es saber en qué medida las colecciones de arte indígena americano conservadas en instituciones museísticas son potencialmente apt...

Prevalencia de síntomas depresivos e invarianza factorial de la Escala de Depresión del Centro de Estudios Epidemiológicos (CES-D) en población indígena mexicana.

Science.gov (United States)

Franco-Díaz, Karen Lizbeth; Fernández-Niño, Julián Alfredo; Astudillo-García, Claudia Iveth

2018-05-01

Introducción. La versión breve de la Escala de Depresión del Centro de Estudios Epidemiológicos (CESD) es un recurso factible para la tamización de los síntomas de depresión en la población general, pero no se ha reportado la prevalencia en la población indígena, ni su invarianza factorial en Latinoamérica.Objetivo. Describir la prevalencia de los síntomas de depresión y la invarianza factorial de la versión breve de la escala CES-D en población indígena mexicana.Materiales y métodos. Se hizo un estudio transversal en una muestra representativa de 37.165 adultos mexicanos de 20 a 59 años de edad. La identidad indígena se determinó mediante el propio reporte de la persona como hablante de una lengua indígena. Se conformaron ocho grupos de análisis según el sexo, el alfabetismo y el ser indígena. Se describió la prevalencia de los síntomas depresivos en cada grupo, así como la invarianza factorial de la configuración de los perfiles mediante un análisis factorial exploratorio. Las matrices de varianza y covarianza se compararon entre pares de perfiles usando el test modificado de Mantel.Resultados. La prevalencia de síntomas depresivos en mujeres indígenas que sabían leer fue de 16,8 % (IC95%: 13,4-20,3); en mujeres indígenas que no sabían leer, de 21,3 % (IC95%: 15,5-27,1); en hombres indígenas que sabían leer de 8,5 % (IC95%: 6,0-11,1), y en hombres indígenas que no sabían leer de 10,4 % (IC95%: 5,2-15,6). No se encontraron diferencias significativas en las cargas factoriales entre los perfiles.Conclusión. Se reportó una menor prevalencia de síntomas depresivos en indígenas que en la población no indígena. La escala CES-D en su versión breve mostró invarianza factorial al emplearla en la población indígena.

Exploratory behaviour, emotional wellbeing and childcare quality in preschool education

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Alexander Barandiaran

2015-05-01

Full Text Available The aim of this study was to examine the relationship between children exploratory behaviour and the quality of structural childcare and process in preschools. The study also examined how childcare quality affects the relationship between emotional wellbeing and exploratory behaviour. The sample comprised 206 children from 40 classrooms in 20 preschools, together with their teachers. The children's age ranged between 37 and 64 months (M = 50.96, SD = 6.54. The results indicated that children cared for by more sensitive teachers engaged in more exploratory behavior. However, no moderating effect was found of teacher sensitivity on the positive relationship between exploratory behavior and wellbeing. Finally, some factors linked to the quality of structural childcare also influenced exploratory behavior, although to a lesser extent.

An economic and financial exploratory

Science.gov (United States)

Cincotti, S.; Sornette, D.; Treleaven, P.; Battiston, S.; Caldarelli, G.; Hommes, C.; Kirman, A.

2012-11-01

This paper describes the vision of a European Exploratory for economics and finance using an interdisciplinary consortium of economists, natural scientists, computer scientists and engineers, who will combine their expertise to address the enormous challenges of the 21st century. This Academic Public facility is intended for economic modelling, investigating all aspects of risk and stability, improving financial technology, and evaluating proposed regulatory and taxation changes. The European Exploratory for economics and finance will be constituted as a network of infrastructure, observatories, data repositories, services and facilities and will foster the creation of a new cross-disciplinary research community of social scientists, complexity scientists and computing (ICT) scientists to collaborate in investigating major issues in economics and finance. It is also considered a cradle for training and collaboration with the private sector to spur spin-offs and job creations in Europe in the finance and economic sectors. The Exploratory will allow Social Scientists and Regulators as well as Policy Makers and the private sector to conduct realistic investigations with real economic, financial and social data. The Exploratory will (i) continuously monitor and evaluate the status of the economies of countries in their various components, (ii) use, extend and develop a large variety of methods including data mining, process mining, computational and artificial intelligence and every other computer and complex science techniques coupled with economic theory and econometric, and (iii) provide the framework and infrastructure to perform what-if analysis, scenario evaluations and computational, laboratory, field and web experiments to inform decision makers and help develop innovative policy, market and regulation designs.

De l’image au voyage : l’Inde sur la route de soi From image to journey: India on the road to herself

Directory of Open Access Journals (Sweden)

Anthony Goreau-Ponceaud

2008-10-01

Full Text Available L’Inde, pour les marchands de voyage, existe seulement par l’imaginaire qu’elle suscite et qui la fait renaître à chaque instant. Cet imaginaire dans la construction du discours touristique se joue d’un ensemble de représentations qui s’articule sur trois registres : l’Inde intemporelle, l’Inde spirituelle et l’Inde pauvre. Ces registres déterminent des hauts lieux qui sont à la fois porteurs d’exotisme, d’affect, d’émotions et d’identité, dont la carte est révélatrice des différents discours utilisés et usés par les marchands de voyage. Ces suppositions stéréotypées et la rhétorique iconographique utilisées sont indicatives d’un discours selon lequel l’Inde mystique, traditionnelle et démunie, sert de contrepoint à l’Occident rationnel, moderne et développé. Ainsi nous verrons que ces suppositions procèdent comme toute instrumentalisation par métaphores et synecdoques : l’Inde c’est l’hindouisme, un pèlerinage aux sources de la sagesse où y abondent populations tribales, maharajas, fauves, charmeurs de serpents, bosquets luxuriants et temples. Ces images font de l’Inde un monde où le temps semble s’arrêter.In the eyes of the travel merchants, India exists only through the imaginary dimension she elicits and that constantly recreates her. This imaginary element in the construction of a tourist discourse plays on a set of representations which focus on three themes: a timeless India, a spiritual India and a poor India. These themes determine high places which are both carriers of exoticism, affection, emotion and identity, and whose map is indicative of the variety of discourses used by travel merchants. These stereotypical suppositions and the iconographic rhetoric used are indicative of a thought according to which this mystical, traditional and destitute India, acts as a counterpoint to a rational, modern and developed West. Thus, it will be shown that, instrumentally, these

Analisis Fundamеntal untuk Mеnilai Kеwajaran Harga Saham Dеngan Pеndеkatan Discountеd Cash Flow (Studi pada Pеrusahaan Dеngan Kapitalisasi Pasar Tеrbеsar dari Jakarta Islamic Indеx dan Ftsе Bursa Malaysia Hijrah Shariah Indеx Pеriodе 2011-2015)

OpenAIRE

Jatnika, Oktana Indriyatna; Nuzula, Nila Firdausi

2017-01-01

Thе rеsеarch is conductеd to find out thе fairnеss of sharе pricе of sharia companiеs listеd in Bursa Еfеk Indonеsia and Bursa Malaysia and to givе rеcommеndation rеlatеd to thе valuation rеsult obtainеd by using fundamеntal analysis of Discountеd Cash Flow (DCF) approach. Thе rеsеarch typе is dеscriptivе rеsеarch with quantitativе approach. Thе population in this study arе all companiеs listеd in Jakarta Islamic Indеx (JII) and FTSЕ Bursa Malaysia Hijrah Shariah Indеx (FBMHS) in 2015. Total ...

FDA direct-to-consumer advertising for prescription drugs: what are consumer preferences and response tendencies?

Science.gov (United States)

Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza

2007-01-01

The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources.

Arte, Indústria Cultural e educação

Directory of Open Access Journals (Sweden)

LUCI MARA BERTONI

Full Text Available A necessidade, cada vez mais crescente, da busca de felicidade tem feito com que as pessoas se deixem influenciar pelo consumo desmedido dos produtos ofertados pela Indústria Cultural, fazendo da arte, de modo especial, da música, um meio de tornar-se igual sem perceber que estão se colocando à margem de sua própria cultura. Neste sentido, é necessário repensar quais são as contribuições da educação no intuito de formar para a emancipação e para a resistência, segundo as concepções adornianas.

Protocole d'entente entre le gouvernement de l'Inde et le CRDI ...

International Development Research Centre (IDRC) Digital Library (Canada)

22 févr. 2018 ... Ce protocole d'entente réaffirme un engagement commun envers les données probantes et l'innovation en Inde en vue de favoriser le progrès social et ... Des chercheurs appuyés par le CRDI parlent de leurs expériences au Comité sur les ONG lors du forum de la Commission de la condition de la femme.

Inde | Page 6 | CRDI - Centre de recherches pour le développement ...

International Development Research Centre (IDRC) Digital Library (Canada)

Les économistes et les spécialistes en sciences sociales ont vigoureusement plaidé en faveur d'une réduction des dépenses en subventions et de la création d'un revenu de base pour les populations de l'Inde à la Conférence nationale sur le revenu de base universel appuyée par le CRDI. Read more about Les ...

21 CFR 1.378 - What criteria does FDA use to order a detention?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What criteria does FDA use to order a detention? 1.378 Section 1.378 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption...

Um estudo comparativo entre os modelos de instalação e consolidação das indústrias aeronáuticas brasileiras e canadenses

Directory of Open Access Journals (Sweden)

José Fernando Touguinha de Almeida

2016-01-01

Full Text Available No atual cenário econômico mundial, altamente competitivo e globalizado, as indústrias introduziram significativas mudanças nas estruturas organizacionais, principalmente aquelas dependentes de alta tecnologia, remodelando suas estratégias de negócio e redefinindo os modelos de parcerias com a cadeia produtiva e a rede de clientes. Nesse novo contexto econômico, as transferências de tecnologia se transformaram em um importante diferencial competitivo para as indústrias com base tecnológica, permitindo a especialização das empresas nos seus segmentos de atuação. Alguns modelos de transferência de tecnologia foram propostos e adotados mundialmente pelas indústrias, e o setor aeronáutico foi um dos que implementaram esses modelos e que mais evoluíram na busca do modelo colaborativo ideal, formando clusters e arranjos produtivos locais para consolidar e fortalecer os resultados. O objetivo desta pesquisa é discutir os modelos de instalação e consolidação adotados pelas indústrias aeronáuticas canadense e brasileira, identificando suas diferenças e similaridades. Para tanto, a metodologia baseou-se na utilização da abordagem qualitativa e de pesquisa documental. Com essa abordagem foi possível realizar uma análise completa e detalhada dos modelos de instalação e consolidação adotados pelas indústrias aeronáuticas brasileira e canadense. Os resultados apontam que, embora as duas principais empresas montadoras de aeronaves brasileira e canadense atuem no mesmo segmento da aviação regional, a formação das indústrias aeronáuticas brasileira e canadense se deu de maneira diferente, justificando o distinto estágio tecnológico em que se encontram atualmente.

El doble carácter de la educación indígena: reproducción y resistencia

Directory of Open Access Journals (Sweden)

Alberto Padilla Arias

2002-01-01

Full Text Available Las reflexiones contenidas en este trabajo son el resultado de la interpretación de los datos producto de la investigación sobre el tema y se enmarcan dentro de la concepción epistemológica denominada: la cultura como categoría crítica, que ha sido desarrollada por diversos intelectuales latinoamericanos, en particular por Paulo Freire. El método de trabajo ha sido esencialmente de carácter documental. En este punto, a principios del siglo XXI, la investigación ha venido a evidenciar que tanto la educación formal como la no formal, —de los que nosotros llamaremos en adelante pueblos originarios o indígenas— en general, continúa sirviendo a la reproducción de los moldes culturales hegemónicos, tanto en su versión pública como privada. Sin embargo, por otra parte, la educación informal es la que ha permitido, a la mayoría de los pueblos indígenas y sus culturas, ejercer sus mecanismos de resistencia cultural, apoyando su supervivencia, no solamente en México, sino en cualquier punto del planeta dentro del nuevo esquema de regionalización-globalización. Es por ello que se puede afirmar que la educación indígena de hecho tiene un doble carácter como reza el título: reproducción y resistencia. Todo ello teniendo en cuenta múltiples factores que intervienen en los contextos nacionales con su naturaleza multicultural. En el trabajo se analizan las condiciones de diversos pueblos originarios o “indígenas” que han logrado sobrevivir con sus propias culturas, gracias a que han hecho uso de este proceso conservador autónomo, educación informal; así como la propuesta de Paulo Freire.

Natureza e sociedade nos aldeamentos indígenas do império: diálogos da ordem menor dos frades capuchinhos com a história natural

Directory of Open Access Journals (Sweden)

Marta Amoroso

2010-06-01

Full Text Available Focaliza-se a montagem dos aldeamentos indígenas administrados pelos frades capuchinhos italianos na segunda metade do século XIX na região dos rios Doce e Mucuri, em Minas Gerais. O foco da análise recai sobre as teorias de natureza e sociedade que orientaram tanto a política de assentamento dos índios comoa montagem das colônias de imigrantes implantadas naregião. Interessa-nos especialmente acompanhar em que termos, naquele momento particular e falando diretamente do local, formularam-se as noções de natureza e sociedade mobilizadas no projeto de construção e manutenção dos aldeamentos indígenas do Império. Busca-se apresentar o aldeamento indígena de Itambacuri como um caso exemplar da disputaentre programas diferenciados de cultivo da paisagem (T. Ingold, 2000 um tipo de controvérsia que caracterizou, de modo geral, o programa "Catequese e civilização" do governo do Império, voltado para as populações indígenas. O acontecimento da criação do aldeamento indígena e os agenciamentos dele decorrentes, envolvendo os próprios grupos indígenas, imigrantes europeus e migrantes nordestinos, oferecem oportunidade para se considerar, a partir do relato dos missionários e da historiografia da Ordem Menor, quais as possibilidades de diálogo entre ciência e religião no século XIX

Terminología botánica indígena en el vocabulario castellano-mexicano (1555 de Fray A. de Molina

Directory of Open Access Journals (Sweden)

Galeote Manuel

2002-06-01

Full Text Available

Las voces indígenas de la flora americana, que fray Alonso de Molina incluye en la sección castellana de su obra: Aquí comience un vocabulario en la lengua castellana y mexicana (México, Juan Pablos, 1555 se analizan desde el punto de vista histórico y sociolingüístico. Se trata del primer vocabulario de Molina el Nebrija de las Indias y, además, el primer diccionario impreso en México y en América. En las entradas castellanas, los términos indígenas americanos de la flora (plantas y frutas constituyen uno de los campos onomasiológicos más numerosos (maíz, cacao, maguey, chía, ají, etc. De los once términos indígenas hemos contabilizado casi un centenar de ocurrencias. En conclusión, este vocabulario muestra el fondo léxico patrimonial del español y los indoamericanismos que se acomodaron a las estructuras de la lengua castellana.

Synthesis and characterization of a microporous 6FDA-polyimide made from a novel carbocyclic pseudo Tröger's base diamine: Effect of bicyclic bridge on gas transport properties

KAUST Repository

Abdulhamid, Mahmoud A.; Ma, Xiaohua; Miao, Xiaohe; Pinnau, Ingo

2017-01-01

,11-methanodibenzo[a,e][8]annulene (iCTBDA), were designed for the synthesis of microporous 6FDA-based polyimides (6FDA-CTBDA and 6FDA-iCTBDA). Both polyimides were soluble, exhibited excellent thermal stability of ∼490 °C, and had high surface areas of 587 m2 g−1 (6

Mining FDA drug labels using an unsupervised learning technique--topic modeling.

Science.gov (United States)

Bisgin, Halil; Liu, Zhichao; Fang, Hong; Xu, Xiaowei; Tong, Weida

2011-10-18

The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering "topics" that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that might arise from specific

Mining FDA drug labels using an unsupervised learning technique - topic modeling

Science.gov (United States)

2011-01-01

Background The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. Method In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering “topics” that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. Results The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that

Modelo de direcionamentos para melhorias do fluxo de informação da cadeia de suprimentos da indústria da construção civil imobiliária

OpenAIRE

Barretto, Germano Rodrigo Pacheco de Sá

2009-01-01

Tradicionalmente, a construção civil trabalha com certa defasagem tecnológica e gerencial se comparada com outros segmentos indústrias, como, por exemplo, a indústria de bens de consumo. Seguindo o exemplo de outros modelos de gestão que foram inicialmente difundidos pela a indústria manufatureira, a gestão da cadeia de suprimentos surge como solução para muitos dos problemas de ineficiência do setor da construção civil imobiliária. O objetivo do presente trabalho é propor alguns direcionamen...

Estimación del número de indígenas en la región nordeste del Uruguay a partir de ADNmt

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Sans, Mónica

2001-01-01

Full Text Available A partir del estudio del ADNmt en la población actual de los departamentos de Tacuarembó y Cerro Largo, se concluyó que el 59% de la población de Tacuarembó y el 30% en Cerro Largo tenían haplogrupos indígenas (se analizaron los haplogrupos A, B, C, D, y en el segundo caso, también el X. El objetivo de esta ponencia fue realizar una aproximación al número de mujeres indígenas que potencialmente contribuyeron con sus haplogrupos a la conformación de la población actual. Para esto, se analizan los datos genéticos con relación a datos censales, estimaciones y anuarios estadísticos. Se partió de la transmisión uniparental del ADNmt, asumiendo flujo génico direccional, cruzamientos al azar y a la población indígena como receptora de pobladores no indígenas. El período considerado abarca desde la fundación de las ciudades capitales departamentales (Melo, 1795 y Tacuarembó, 1832 hasta el último censo de población (1996. Para el siglo XX, se calculó el crecimiento vegetativo a partir de datos estadísticos de natalidad y mortalidad, mientras que para el siglo XIX, se realizaron estimaciones a partir de diversos modelos demográficos y datos comparativos. Las diferencias entre estimaciones basadas en el crecimiento vegetativo y los datos censales se interpretan como inmigración de individuos no indígenas o emigración de población al azar. Se discuten los valores de población estimados y las asunciones realizadas.

Exploratory research and development FY90

Energy Technology Data Exchange (ETDEWEB)

Struble, G.L.; Middleton, C.; Baldwin, G.; Cherniak, J.; Clements, W.; Donohue, M.L.; Francke, A.; Kirvel, R.D.; MacGregor, P.; Shaw, G. (eds.)

1990-01-01

In general, the Exploratory Research and Development (ER D) Program supports research projects considered too basic or long-range to be funded by other Lawrence Livermore National Laboratory (LLNL) programs. This Program is managed for the Laboratory Director by a special assistant who chairs the LLNL's IR D Review Committee. Membership in the Review Committee comprises senior LLNL scientists, engineers, and managers whose areas of expertise span the range of scientific disciplines pursued at the Laboratory. The research supported by the Program falls into three categories: Exploratory Research in the Disciplines, Director's Initiatives, and Laboratory-Wide Competition. The first two, Exploratory Research and Director's Initiatives, promote pioneering work in the various scientific disciplines and programmatic areas. Laboratory departments and divisions propose and manage projects in the Exploratory Research category. The Laboratory Director, with the advice of the Review Committee, selects several larger projects to fund as Director's Initiative. These projects, which are proposed and managed by the responsible associate director, are intended to enhance the scope of existing programs or establish new technical directions and programs for the Laboratory. All FY90 projects are described in detail in this report. Other publications on ER D projects are included in the Publications List at the back of this report.

Turismo, patrimonio y comunidades indígenas

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Edna Camila Acero Tinoco

2018-05-01

Full Text Available Si bien es cierto que el capital impacta las diversas dinámicas existentes en el comercio, se debe tener en cuenta que la comunidad que habita en cualquier espacio donde se genere ese comercio ha tenido diferentes transformaciones a lo largo del tiempo en búsqueda de sus necesidades, creando medios sociales de comercio a partir de la naturaleza que los rodea (Marx, 1971, p. 37. Una de las actividades económicas que genera transformaciones e impactos es el fenómeno turístico, que a pesar de su orientación productivista lleva consigo una connotación sociológica importante, dada la posibilidad de interacción simbólica entre la visión del consumidor turístico y la del sujeto receptor. Dicha interacción genera intercambios culturales complejos y transformaciones en las dinámicas locales debido a la necesidad naciente de conocer lo desconocido y redescubrir al otro, como una forma de materializar el turismo e industrializar la cultura. Los beneficios económicos del turismo no se convierten en beneficios sociales, pues son diseñados sin conocer la realidad de las comunidades. Así mismo, es inevitable el cambio en los comportamientos generales debido a la transformación de la estructura cultural como consecuencia de los intercambios sociales. El turismo es el que determina cómo deben actuar, comportarse, vestirse, qué deben mostrar y qué pueden vender las comunidades, por lo cual, en la mayoría de las ocasiones, estas maquillan sus cuerpos y buscan recrear el discurso del buen salvaje por medio de la danza, los cantos, las lenguas aborígenes y el aspecto de sumisión. Es por lo anterior que el objetivo de esta investigación es, grosso modo, conocer los impactos que genera la actividad turística en las comunidades indígenas a partir del discurso colonial. Este discurso sigue siendo reproducido como una forma de vender un producto turístico llamado cultura y patrimonio, representado en las diferentes comunidades indígenas del

Sociometric Indicators of Leadership: An Exploratory Analysis

Science.gov (United States)

2018-01-01

Research Report 2015 Sociometric Indicators of Leadership : An Exploratory Analysis Elizabeth R. Uhl U.S. Army...2017 4. TITLE AND SUBTITLE Sociometric Indicators of Leadership : An Exploratory Analysis 5a. CONTRACT NUMBER W5J9CQ-11-D-0001 5b...objectives and a discussion of the strengths and weaknesses of the wearable sensor technology. 15. SUBJECT TERMS Leadership ; Social Network; Sociometric

“A sociedade brasileira nos fez pobres”: assistência social e autonomia étnica dos povos indígenas. O caso de Dourados, Mato Grosso do Sul

Directory of Open Access Journals (Sweden)

Júlio César Borges

Full Text Available Resumo O artigo pretende analisar a relação dos povos indígenas com a política pública de assistência social (AS no Brasil. Com base em dados coletados durante trabalho de campo realizado, no ano de 2014, será analisado o caso da Reserva Indígena de Dourados, Mato Grosso do Sul. Na primeira parte, caracterizo a relação desigual da sociedade e Estado nacionais com os povos indígenas para, em seguida, abordar a política de assistência social como oportunidade estatal de enfrentamento da violação de direitos decorrente do cerco colonial. Em seguida, veremos o caso de Dourados como ilustração dos dilemas e possibilidades da autonomia e protagonismo indígena frente a essa política pública. Espera-se contribuir com a discussão em torno da estatalidade apontando casos concretos em que a implementação local da política de AS é permeável, em maior ou menor medida, às demandas dos povos indígenas por adequação às suas organizações sociais e visões de mundo.

Leadership approaches in multi-cultural aviation environments = Abordagem de liderança em ambientes multiculturais da indústria da aviação

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Brito Neto, José Felix de

2014-01-01

Full Text Available Nas últimas décadas, o mundo tem testemunhado um fenômeno chamado globalização, que tem encurtado distâncias e transformado contextos culturais. A indústria da aviação tem sido parte desse fenômeno por ter ajudado a criar mãos de obra verdadeiramente globais e multiculturais. Ambientes de trabalho multiculturais como o da indústria da aviação requer específicas abordagens de liderança para poder acomodar as necessidades das suas mãos de obra multiculturais. Este artigo tem como objetivo a análise minuciosa de abordagens de liderança em ambientes de trabalho multiculturais dentro da indústria de aviação. Através da revisão da literatura, este artigo discute conceitos-chave a respeito de cultura e liderança como também de ideias que apoiam a teoria da liderança transformacional e a teoria da liderança positiva. O artigo propõe diferentes abordagens para a liderança bem-sucedida e efetiva de mãos de obra multiculturais na indústria da aviação

Vulnerabilidad social de las mujeres y la población indígena en Oaxaca, 2005: restricciones y estrategias

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Rafael G. Reyes Morales

2007-05-01

Full Text Available La discusión sobre vulnerabilidad de las mujeres y los indígenas en el estado de Oaxaca son: la exclusión de beneficios de las políticas públicas de bienestar, el poder adquisitivo y las estrategias para superar la condición de vulnerabilidad. Los hallazgos del artículo contradicen la situación de relativa precariedad de los hogares con jefatura femenina reportada por la literatura especializada. La migración aparece como un instrumento que contribuye a la equidad de género y permite elevar la escolaridad de la población indígena.

"Sin música no hay fiesta, no hay nada": aproximaciones a las expresiones musicales indígenas en Chiapas

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Marina Alonso Bolaños

2012-01-01

Full Text Available Desde un enfoque antropológico del arte y la estética, en este artículo se exploran las posibilidades para abordar aspectos de la constitución de las expresiones musicales indígenas contemporáneas del estado del Chiapas, en el sureste de México. Se discuten también, las perspectivas indígenas acerca de los procesos de creación musical (interpretación y transmisión-aprendizaje, el papel de los instrumentos musicales y en la audiencia, así como la coexistencia de los distintos estilos y formas, géneros y repertorios musicales.

Marketing verde e práticas socioambientais nas indústrias do Paraná

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Valéria Neder Lopes

2014-03-01

Full Text Available A preocupação das empresas com o meio ambiente e com todas as questões sociais envolvidas em seu processo tem se tornado uma constante nos últimos tempos. Devido a isso, estão surgindo novas formas de administrar os recursos disponíveis. Nesse contexto, enquadra-se o marketing verde que deve estar pautado em práticas ambientalmente corretas, com o intuito de gerar produtos e serviços mais sustentáveis, fortalecendo a imagem das empresas e diferenciando suas marcas no mercado. O intuito neste trabalho foi verificar se as grandes indústrias do Paraná estão se utilizando das práticas de marketing verde e se mantêm projetos de gestão socioambiental. Para atender a tais objetivos, elaborou-se uma pesquisa descritiva e quantitativa com 48 grandes empresas cadastradas na Federação das Indústrias do Paraná. Os resultados obtidos indicam que a maior parte das empresas possui departamento de marketing formalizado, mantém sistemas de gestão ambiental e utiliza moderadamente práticas de marketing verde.

FDA approved drugs as potential Ebola treatments [v2; ref status: indexed, http://f1000r.es/554

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Sean Ekins

2015-03-01

Full Text Available In the search for treatments for the Ebola Virus, multiple screens of FDA drugs have led to the identification of several with promising in vitro activity. These compounds were not originally developed as antivirals and some have been further tested in mouse in vivo models. We put forward the opinion that some of these drugs could be evaluated further and move into the clinic as they are already FDA approved and in many cases readily available. This may be important if there is a further outbreak in future and no other therapeutic is available.

Exact capture probability analysis of GSC receivers over i.n.d. Rayleigh fading channels

KAUST Repository

Nam, Sungsik

2013-07-01

A closed-form expression of the capture probability of generalized selection combining (GSC) RAKE receivers was introduced in [1]. The idea behind this new performance metric is to quantify how the remaining set of uncombined paths affects the overall performance both in terms of loss in power and increase in interference levels. In this previous work, the assumption was made that the fading is both independent and identically distributed from path to path. However, the average strength of each path is different in reality. In order to derive a closed-form expression of the capture probability over independent and non-identically distributed (i.n.d.) fading channels, we need to derive the joint statistics of ordered non-identical exponential variates. With this motivation in mind, we first provide in this paper some new order statistics results in terms of both moment generating function (MGF) and probability density function (PDF) expressions under an i.n.d. assumption and then derive a new exact closed-form expression for the capture probability GSC RAKE receivers in this more realistic scenario. © 2013 IEEE.

The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

Science.gov (United States)

Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

2012-01-01

Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.

La diffusion spatiale de l’informatique en Inde

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Divya Leducq

2009-09-01

Full Text Available L’Inde est une puissance émergente qui s’affirme, entre autres, à travers son secteur des services informatiques aux entreprises. Dans ce pays, lesTechnologies de l’Informationet de la Communication (TIC sont perçues comme un moteur de développement. Le modèle du cluster géographique et économiques’est imposé progressivement comme outil d’aménagement dans l’ensemble des politiques sectorielles menées par l’État indien et reprises par les États fédérés. La diffusion de cet outil est liée aux succès qui ont fait la renommée de l’Inde dans le secteur des logiciels, aux bénéfices attendus en matière d’innovation, mais aussi à des raisons pratiques et foncières. Cet article présente à travers un prisme géoéconomique les stratégies de développement successives basées sur la création de clusters TIC multi-échelles,en analysant l’exemple précis de l’État du Kerala.India is an emergent superpower which asserts itself through outsourced services, the so-called “IT industry”. Beyond the fact that InfoTech are seen as a trickle-down development engine, it is the cluster which has become gradually a town planning measure in the sectoral policies followed by the central government and the regional states. The diffusion of this spatial model can be explained by the success stories which made the reputation of India and the expected benefits in terms of innovation. This article analyzes the successive strategies of development based on IT clusters through a geographical and economical prism. The role of the scales and of the actors will be emphasized, while resting on the specific instance of the Kerala state.

Posição de fronteira e produção de significados na educação matemática indígena

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Lucí T. M. dos Santos Bernardi

2013-01-01

Full Text Available O presente trabalho apresenta parte dos resultados de uma pesquisa que teve como objetivo acompanhar um processo de formação continuada de um grupo de professores indígenas Kaingang que ensinam matemática, na Terra Indígena Xapecó, em Ipuaçu, SC. Tal pesquisa buscou promover uma reflexão sobre os desafios da Educação Escolar Indígena na construção de um processo educativo na Educação Matemática, mais especificamente que, na construção desse processo educativo, contemplasse a matemática tradicional e a matemática escolar. Examinamos, a questão da posição de fronteira do estudante/professor indígena, tratando das diversidades e conflitos culturais, background e foreground, e da construção de significados da matemática na educação matemática indígena. Para isso, buscamos aporte teórico na Educação Matemática Crítica na Etnomatemática. A pesquisa nos mostrou que um dos caminhos para minimizar o enfrentamento dos desafios seria suavizar as fronteiras entre indígenas e não indígenas e reforçar os marcadores identitários, compreendendo uma nova lógica para a elaboração de significados dos elementos de sua cultura.Abstract This paper presents some results of a survey that aimed to follow a process of continuous formation of a group of Kaingang indigenous teachers who teach mathematics in Terra Indigena Xapecó in Ipuaçu, SC. This research sought promote reflection on the challenges of Indigenous Education in the construction of an educational process in mathematics education, specifically that the construction of this educational process, contemplating the traditional mathematics and mathematics education. Examined the issue of frontier position of the teacher indigenous dealing with diversity and cultural conflicts, background and foreground, and the construction of meanings of mathematics in mathematics indigenous education. For this, we seek the theorical support in Critical Mathematics Education and in

Reflexiones ético-políticas sobre los derechos colectivos de los pueblos indígenas; Reflexões ético-políticas sobre os direitos coletivos dos povos indígenas; Ethical-political reflections on the collective rights of indigenous peoples

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Ana Luisa Guerrero Guerrero

2018-01-01

Full Text Available Resumen: En esta ocasión abordaré algunas cuestiones sobre las implicaciones ético-políticas del reconocimiento internacional de los derechos de los pueblos indígenas, ya que en ellos se encuentran concepciones que enriquecen la defensa de la integridad humana y que vienen a ser un eje de sustento que se incorpora al ya existente de la tradición occidental moderna de los derechos humanos, acontecimiento que motiva reflexiones sobre las relaciones entre el poder político y estos pueblos en nuestra región. Palabras clave: Derechos Humanos, pueblos indígenas, política   Resumo: Nesta ocasião, abordarei algumas questões sobre as implicações ético-políticas do reconhecimento internacional dos direitos dos povos indígenas, uma vez que contêm conceitos que enriquecem a defesa da integridade humana e que se tornam um eixo de subsistência incorporado para a atual tradição ocidental moderna dos direitos humanos, evento que motiva as reflexões sobre as relações entre o poder político e essas pessoas em nossa região. Palavras-chave: Direitos humanos, povos indígenas, política   Abstrac: On this occasion I will address some questions about the ethical-political implications of the international recognition of the rights of indigenous peoples, since they contain concepts that enrich the defense of human integrity and that become an axis of livelihood that is incorporated to the existing one of the modern western tradition of the human rights, event that motivates reflections on the relations between the political power and these people in our region. Keywords: Human rights, indigenous peoples, politics

Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters.

Science.gov (United States)

Kim, Hyosun

2015-08-25

For the purpose of understanding the Food and Drug Administration's (FDA's) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers. The FDA's warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed. Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus begun to keep tabs on social media promotions of

El misionero ante las culturas Indígenas

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Gerardo Reichel Dolmatoff

2013-11-01

Full Text Available La presente comunicación tiene por objeto describir, desde el punto de vista , algunos aspectos del contacto cultural entre el Misionero y el Indígena.  Referiré principalmente a aquellos factores que son negativos y  en estas situaciones de contacto, es decir, mi comunicación critica a un sistema y aun complejo de actividades prevalentes. Al hablar como , es que no nos entendamos en algunos puntos; pero al hablar  defensa del indio, estoy seguro de que ustedes concordarán conmigo pues voy  hablar del hombre, de este ser que es el centro de nuestras preocupaciones y  es la base y razón de nuestro común esfuerzo.

Inclusión de los estándares internacionales sobre los derechos de los pueblos indígenas en políticas bancarias y programas REDD+

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Johanna Fonseca

2013-06-01

Full Text Available El presente ensayo analiza la inclusión de los derechos de los pueblos indígenas en el derecho y la política internacional, en el marco del Derecho Internacional de los Derechos Humanos. El objetivo de tal reflexión es determinar el grado de implementación de los estándares internacionales sobre los derechos de los pueblos indígenas por parte de los Estados, en particular Guatemala, respecto a los programas y proyectos de desarrollo. Para lograr tal objetivo, en un primer momento, se refleja la evolución del derecho internacional en torno al reconocimiento de los derechos de los pueblos indígenas. Posteriormente, se analiza la adecuación del derecho interno de los Estados a los estándares internacionales y regionales en la materia a la luz de las obligaciones internacionales de derechos humanos correspondientes y, finalmente, se aborda la consideración estatal de los derechos de los pueblos indígenas en programas y proyectos de desarrollo.

Trabajo y Comunidad. Reproducción Social, Económica y Cultural de la Población Indígena en el Estado de México

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Leif Korsbaek

1999-01-01

Full Text Available Después de una presentación global de la población indígena en el Estado de México, dirigiendo la atención hacia los cinco grupos étnicos autóctonos: los mazahua, otomí, matlatzinca, tlahuica y náhuatl y destacando la importancia de la comunidad indígena como el núcleo de esta población, se presenta lo que en nuestra opinión es el prin ci pal reto etnográfico en el Estado de México: el hecho de que la reproducción socioeconómica de la población indígena se lleva a cabo dentro del marco del mundo moderno en las zonas conurbadas alrededor de la ciudad de México, donde la mayoría de sus integrantes se ganan la vida como trabajadores asalariados, mientras que su reproducción cul tural se lleva a cabo en el marco de la comunidad indígena con sus instituciones tradicionales, notablemente el sistema de car gos.

Currículo y construcción de identidad en contextos indígenas chilenos Currículo e construção de identidade em contextos indígenas chilenos Curriculum and Building Identity in Chilean Indigenous Contexts

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Omar Rolando Turra-Díaz

2012-04-01

Full Text Available En este artículo se presentan los resultados de una investigación que tuvo como propósito indagar en la producción y definición curricular del sector de aprendizaje Historia y Ciencias Sociales en un contexto indígena intercultural (Provincia de Arauco-Chile. Con base en un estudio empírico-documental se examina la efectiva incorporación de saberes culturales mapuche en los contenidos escolares del sector de aprendizaje a partir de la declaración de reconocimiento de la diversidad cultural y la promoción de la afirmación identitaria propuesta por los principios orientadores del diseño curricular que surgió con la reforma educativa de finales de los años noventa en Chile. Los resultados demuestran que las comunidades docentes en contexto indígena intercultural no han diseñado programas de estudios propios que incorporen la cultura de referencia de los educandos indígenas-mapuche en sus procesos pedagógicos; por el contrario, implementan en plenitud los programas de estudios ministeriales que consideran escasamente las formas culturales mapuche en su propuesta curricular.Neste artigo, apresentam-se os resultados de uma pesquisa que teve como propósito indagar na produção e definição curricular do setor de aprendizagem história e ciências sociais em um contexto indígena intercultural (estado de Arauco - Chile. Com base em um estudo empírico-documental, examina-se a efetiva incorporação de saberes culturais mapuche nos conteúdos escolares do setor de aprendizagem a partir da declaração de reconhecimento da diversidade cultural e da promoção da afirmação identitária proposta pelos princípios orientadores do desenho curricular que surgiu com a reforma educativa do final dos anos noventa no Chile. Os resultados demonstram que as comunidades docentes em contexto indígena intercultural não têm desenhado programas de estudos próprios que incorporem a cultura de referência dos educandos indígenas-mapuche em seus

Breve caracterização do Instituto Cubano de Arte e Indústria Cinematográfica como indústria cultural

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Hansel Pavel Oro Oro

2016-11-01

Full Text Available A Economia Política da Comunicação proporciona a plataforma teórica para compreender o movimiento cinematográfico cubano a partir do conceito de indústria cultural. A concepção fundacional do ICAIC sobre o cinema como realização artística mais do que econômica resulta coerente com a condição improdutiva do trabalho e o alto valor social que caracteriza essa atividade. Constata-se, não obstante, contradições e tensões críticas em relação à finalidade social e a sustentabilidade econômica, a produção do autor e as fontes de financiamento, a defesa da identidade nacional e a necessidade de inserção nos circuitos comerciales globais.

SPINS-IND: Pellet injector for fuelling of magnetically confined fusion systems

Science.gov (United States)

Gangradey, R.; Mishra, J.; Mukherjee, S.; Panchal, P.; Nayak, P.; Agarwal, J.; Saxena, Y. C.

2017-06-01

Using a Gifford-McMahon cycle cryocooler based refrigeration system, a single barrel hydrogen pellet injection (SPINS-IND) system is indigenously developed at Institute for Plasma Research, India. The injector is based on a pipe gun concept, where a pellet formed in situ in the gun barrel is accelerated to high speed using high pressure light propellant gas. The pellet size is decided by considering the Greenwald density limit and its speed is decided by considering a neutral gas shielding model based scaling law. The pellet shape is cylindrical of dimension (1.6 mm ℓ × 1.8 mm φ). For pellet ejection and acceleration, a fast opening valve of short opening duration is installed at the breech of the barrel. A three-stage differential pumping system is used to restrict the flow of the propellant gas into the plasma vacuum vessel. Diagnostic systems such as light gate and fast imaging camera (240 000 frames/s) are employed to measure the pellet speed and size, respectively. A trigger circuit and a programmable logic controller based integrated control system developed on LabVIEW enables to control the pellet injector remotely. Using helium as a propellant gas, the pellet speed is varied in the range 650 m/s-800 m/s. The reliability of pellet formation and ejection is found to be more than 95%. This paper describes the details of SPINS-IND and its test results.

The evolution of FDA policy on silicone breast implants: a case study of politics, bureaucracy, and business in the process of decision-making.

Science.gov (United States)

Palley, H A

1995-01-01

The central issue facing federal regulation of breast implants is that while such devices are not functionally necessary or needed for survival, the side effects may be harmful and have not been proven unharmful. The Medical Device Amendments of 1976 appear to require such evidence prior to the FDA permitting the unrestricted marketing of these devices. However, only recently have such requirements been imposed by the FDA. The author examines the FDA's decision-making process, particularly as applied to silicone breast implants, and the factors that appears to have affected such decisions. In pursuing this study, the activities of a number of interest-group actors, as well as congressional responses and the role of federal bureaucratic actors, were examined. In 1992, the FDA established a regulatory protocol that effectively withdrew most silicone breast implants from the market for the purpose of breast augmentation and allows for the monitoring of the impact of new implants on women's health. This increase concern for determining the safety of breast implants is due to a number of factors, which are examined in this article.

Educación para la prevención del VIH-SIDA para inmigrantes indígenas en Baja California

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Elizabeth Maier

2007-01-01

Full Text Available El objetivo del presente artículo es anclar el análisis de una experiencia de investigación-acción en educación, para la prevención del VIH-SIDA en comunidades indígenas inmigrantes en Baja California, a un marco teórico y fenomenológico que organice las dimensiones múltiples de la problemática, y permita mayor comprensión del significado de la pandemia para estas comunidades, el sentido de la participación de las actoras principales del proyecto, sus resultados, las implicaciones de la articulación de la perspectiva de género y una orientación cultural para su éxito. Se utiliza la categoría vulnerabilidad, para ejemplificar las condiciones de vida tan frágiles de las comunidades indígenas de origen y recepción, los significados subalternos de la identidad tradicional de las indígenas y los riesgos propios de la migración. El artículo interpreta el ejercicio de promoción de la salud comunitaria a partir del sentido cultural de género de las comunidades de origen, los significados históricos y subjetivos de la emigración indígena creciente y los ensayos consiguientes de reorganización social, cultural y genérica, causados por la dislocación migratoria. A partir de este complejo rompecabezas teórico, histórico, fenomenológico y relacional, en los últimos apartados se examina la mecánica del proyecto, sus contenidos y el cúmulo de resultados que la experiencia arrojó a la comunidad y a las promotoras.

Exploratory of society

Science.gov (United States)

Cederman, L.-E.; Conte, R.; Helbing, D.; Nowak, A.; Schweitzer, F.; Vespignani, A.

2012-11-01

A huge flow of quantitative social, demographic and behavioral data is becoming available that traces the activities and interactions of individuals, social patterns, transportation infrastructures and travel fluxes. This has caused, together with innovative computational techniques and methods for modeling social actions in hybrid (natural and artificial) societies, a qualitative change in the ways we model socio-technical systems. For the first time, society can be studied in a comprehensive fashion that addresses social and behavioral complexity. In other words we are in the position to envision the development of large data and computational cyber infrastructure defining an exploratory of society that provides quantitative anticipatory, explanatory and scenario analysis capabilities ranging from emerging infectious disease to conflict and crime surges. The goal of the exploratory of society is to provide the basic infrastructure embedding the framework of tools and knowledge needed for the design of forecast/anticipatory/crisis management approaches to socio technical systems, supporting future decision making procedures by accelerating the scientific cycle that goes from data generation to predictions.

Evaluación del acuerdo de Nueva Imperial y su impacto en la realidad indígena chilena, desde la percepción de la dirigencia aymara

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René Patricio Aguilera Barraza

2006-05-01

Full Text Available Este escrito revisa críticamente, desde el pensamiento de la dirigencia aymara, las repercusiones que tuvo el Acuerdo de Nueva Imperial en la realidad indígena chilena, protocolo acuñado, el año 1989, entre los pueblos precolombinos (Mapuche, Rapa Nui, Kolla, Atacameño y Aymara y los partidos políticos opositores a la dictadura de Augusto Pinochet Ugarte. En él, el movimiento indígena contraía la obligación de apoyar al candidato presidencial Sr. Patricio Aylwin Azocar. A cambio, el entonces candidato de la Concertación de Partidos Políticos por la Democracia, si era electo Presidente de la República, se comprometía a resolver las siguientes demandas indígenas. Primero, elaborar un marco jurídico en favor del desarrollo de los pueblos originarios, punto resuelto con la promulgación de la Ley Indígena Nº 19.253, un 5 de octubre de 1993. Segundo, reconocer constitucionalmente a los pueblos indígenas; y tercero, ratificar el Convenio 169 de la OIT en territorio nacional. El punto dos y tres del Acuerdo de Nueva Imperial permanecen pendientes hasta nuestros días, sin que exista, por parte de las elites de poder que rodean al Estado, la voluntad política para ser aprobados.

21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How will FDA handle classified information in an informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or...

21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... technical advisory committee for human prescription drugs. The Commissioner's determinations on the agenda...

Impaired exploratory eye movements in children with Asperger's syndrome.

Science.gov (United States)

Ohya, Takashi; Morita, Kiichiro; Yamashita, Yushiro; Egami, Chiyomi; Ishii, Youhei; Nagamitsu, Shinichiro; Matsuishi, Toyojiro

2014-03-01

Previous eye-tracking studies using an eye mark recorder have reported that disturbances in exploratory eye movements in adult schizophrenic patients are associated with social functioning. The current study sought to determine whether exploratory eye-movement disturbances are present in children with Asperger's syndrome (AS) compared with typically developing (TD) children. MATERIALS/PARTICIPANTS: The participants were 23 children with AS and 23 age-matched TD children. We measured exploratory eye movements using an EMR-8B eye mark recorder and an exploratory eye movement-measuring device. Eye movements were recorded while participants freely observed a geometric figure (free viewing task), and while they complied with the instructions of an experimenter (repeat-comparison task). We assessed eye fixation points (EFPs) and total eye scanning length (TESL) in all tasks, and measured the responsive search score (RSS) in the repeat-comparison task. In the free viewing task, children with AS exhibited significantly shorter TESL compared with TD children. In the repeat-comparison task, children with AS exhibited significantly lower RSS. Autism Spectrum Screening Questionnaire scores were negatively correlated with both EFP and TESL, but not RSS. The current results revealed that children with AS exhibited dysfunction in exploratory eye movements. Thus, assessing exploratory eye movements in a repeat-comparison task may be useful for detecting social impairment among children with AS. Copyright © 2013 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.

Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry.

Science.gov (United States)

Ciavarella, Anthony B; Khan, Mansoor A; Gupta, Abhay; Faustino, Patrick J

This U.S. Food and Drug Administration (FDA) laboratory study examines the impact of tablet splitting, the effect of tablet splitters, and the presence of a tablet score on the dose uniformity of two model drugs. Whole tablets were purchased from five manufacturers for amlodipine and six for gabapentin. Two splitters were used for each drug product, and the gabapentin tablets were also split by hand. Whole and split amlodipine tablets were tested for content uniformity following the general chapter of the United States Pharmacopeia (USP) Uniformity of Dosage Units , which is a requirement of the new FDA Guidance for Industry on tablet scoring. The USP weight variation method was used for gabapentin split tablets based on the recommendation of the guidance. All whole tablets met the USP acceptance criteria for the Uniformity of Dosage Units. Variation in whole tablet content ranged from 0.5 to 2.1 standard deviation (SD) of the percent label claim. Splitting the unscored amlodipine tablets resulted in a significant increase in dose variability of 6.5-25.4 SD when compared to whole tablets. Split tablets from all amlodipine drug products did not meet the USP acceptance criteria for content uniformity. Variation in the weight for gabapentin split tablets was greater than the whole tablets, ranging from 1.3 to 9.3 SD. All fully scored gabapentin products met the USP acceptance criteria for weight variation. Size, shape, and the presence or absence of a tablet score can affect the content uniformity and weight variation of amlodipine and gabapentin tablets. Tablet splitting produced higher variability. Differences in dose variability and fragmentation were observed between tablet splitters and hand splitting. These results are consistent with the FDA's concerns that tablet splitting can have an effect on the amount of drug present in a split tablet and available for absorption. Tablet splitting has become a very common practice in the United States and throughout the

Suministro de agua domiciliar a tres comunidades indígenas, Guatemala

OpenAIRE

Salvador Otazu, Roberto

2014-01-01

Este proyecto fin de carrera se propone dotar a comunidades indígenas de Fray Bartolomé de las Casas, Departamento de Alta Verapaz (Guatemala), de un mínimo de condiciones higiénico sanitarias básicas, como es el disponer de agua corriente. Se ha tomado como modelo a seguir la ampliación de la red de abastecimiento existente en San Pablo Comunja, a las comunidades de Chimenja, Esperanza Seamay y Nuevo Secapur. Se ampliarán el número de manantiales de abastecimiento (localización, aforos...

Pluralismo jurídico: derecho indígena y justicia nacional

OpenAIRE

Leonello Bertini Chiriboga; Nancy Yáñez Fuenzalida

2013-01-01

A partir de bases doctrinarias y normativas se analizan los avances y retrocesos de la jurisprudencia chilena en relación al reconocimiento de la costumbreindígena, la justiciabilidad del derecho propio indígena y la aplicación de un enfoque de pluralismo jurídico. Existen algunos avances en la jurisprudencia –a partir de la vigencia del Convenio 169 de la OIT– en el reconocimiento del derecho de propiedad ancestral al agua; derechos de uso, aprovechamiento y protección de tierras, recursos n...

O desenvolvimento participativo da área de medicina tradicional indígena, Projeto Vigisus II/Funasa The participant development in traditional indigenous medicine area, Project Vigisus II/Funasa

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Luciane Ouriques Ferreira

2012-05-01

Full Text Available O artigo trata sobre o desenvolvimento participativo das ações da Área de Medicina Tradicional Indígena (AMT do Projeto Vigisus II/FUNASA. A Área tem como objetivo a construção de estratégias para a articulação entre os sistemas médicos indígenas e o sistema oficial de saúde, conforme preconizado pela Política Nacional de Atenção a Saúde dos Povos Indígenas. As principais atividades executadas foram os projetos participativos de pesquisa-ação que podem ser classificados em três eixos transversais: sistemas tradicionais de parto indígenas; plantas medicinais; xamanismo e intermedicalidade. Os resultados qualitativos alcançados pelo eixo sistemas de parto indígenas são aqui apresentados de modo a demonstrar o quanto a articulação dos serviços de saúde com as medicinas tradicionais indígenas é condição fundamental para a efetivação do princípio da integralidade em um modelo diferenciado de atenção à saúde indígena.The article presents the participative planning of health care actions in the Indigenous Traditional Medicine Department, of Project Vigisus II/Funasa (National Foundation for Health. This department's function is to build strategies for the articulation between the indigenous medicine systems and the official health care system, was is established at the National Health Care Policy for Indigenous People. The main activities developed were participant projects of research-action organized along three transverse axes: indigenous childbirth's traditional systems; medicine plants; shamanism and intermedicine. Qualitative results reached at the indigenous systems of childbirth axis are presented here, in order to show how the articulation with traditional indigenous medicine is a core condition to fulfill the principle of integrality in a differentiated model of indigenous health care.

Exploratory shaft conceptual design report: Permian Basin

International Nuclear Information System (INIS)

1983-07-01

This conceptual design report summarizes the conceptualized design for an exploratory shaft facility at a representative site in the Permian Basin locatd in the western part of Texas. Conceptualized designs for other possible locations (Paradox Basin in Utah and Gulf Interior Region salt domes in Louisiana and Mississippi) are summarized in separate reports. The purpose of the exploratory shaft facility is to provide access to the reference repository horizon to permit in situ testing of the salt. The in situ testing is necessary to verify repository salt design parameters, evaluate isotropy and homogeneity of the salt, and provide a demonstration of the constructability and confirmation of the design to gain access to the repository. The fundamental purpose of this conceptual design report is to assure the feasibility of the exploratory shaft project and to develop a reliable cost estimate and realistic schedule. Because a site has not been selected and site-specific subsurface data are not available, it has been necessary to make certain assumptions in order to develop a conceptual design for an exploratory shaft facility in salt. As more definitive information becomes available to support the design process, adjustments in the projected schedule and estimated costs will be required

Exploratory shaft conceptual design report: Paradox Basin

International Nuclear Information System (INIS)

1983-07-01

This conceptual design report summarizes the conceptualized design for an exploratory shaft facility at a representative site in the Paradox Basin located in the southeastern part of Utah. Conceptualized designs for other possible locations (Permian Basin in Texas and Gulf Interior Region salt domes in Louisiana and Mississippi) are summarized in separate reports. The purpose of the exploratory shaft facility is to provide access to the reference repository horizon to permit in situ testing of the salt. The in-situ testing is necessary to verify repository salt design parameters, evaluate isotropy and homogeneity of the salt, and provide a demonstration of the constructability and confirmation of the design to gain access to the repository. The fundamental purpose of this conceptual design report is to assure the feasibility of the exploratory shaft project and to develop a reliable cost estimate and realistic schedule. Because a site has not been selected and site-specific subsurface data are not available, it has been necessary to make certain assumptions in order to develop a conceptual design for an exploratory shaft facility in salt. As more definitive information becomes available to support the design process, adjustments in the projected schedule and estimated costs will be required

Identidades colectivas y proceso de modernización: los indígenas, el Estado y los cambios contemporáneos en el caso boliviano

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H.C.F. Mansilla

2001-07-01

Full Text Available En Bolivia se ha conformado un movimiento popular que intenta reivindicar los derechos indígenas, ante la consigna de! Estado de que este es un país pluricultural. Los grupos nativos cuentan con poca memoria histórica, se han asimilado a la vida urbana y han tomado referentes ajenos a su propia experiencia (identificación con etnias de origen diferente o adhesión de comerciantes indígenas exitosos a partidos populistas. Esto ha desembocado en un lucha ideológica de retroceso a lo premoderno, pero fundadada en intereses particulares. Han comprendido de manera fundamentalista la recuperación de lo étnico, aunque exista una referencia palpable de idioma, costumbres y territorio. Palabras clave: Bolivia, Nación, Indígenas, Multiculturalismo, Ideología, Aculturación.

Educación superior y jóvenes indígenas. Aportes a la discusión desde un abordaje etnográfico

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Mariana Paladino

2016-04-01

Full Text Available Tenemos el gusto de organizar el presente dossier que reúne artículosque resultaron de las reelaboraciones de las ponenciaspresentadas en la mesa de trabajo denominada “Jóvenes indígenasen la educación superior latinoamericana: Políticas y prácticas encontextos de Educación Intercultural Bilingüe”, que coordinamos en elmarco de la I Bienal Latinoamericana de Infancias y Juventudes1.El interés por organizar un dossier sobre esta temática se debe a surelevancia tanto para los estudios antropológicos como para el área delas ciencias de la educación. Los artículos presentados convergen en loque se ha constituido como un nuevo campo de estudio, en el que sepresta singular atención al ingreso y al transcurso de la vida universitariade jóvenes indígenas y de otros sectores definidos como vulnerables.Las perspectivas etnográficas utilizadas permiten comprender la emergenciade la agencia juvenil indígena, en interrelación con las políticaspúblicas implementadas por parte de los gobiernos de la región, comoasí también el accionar de organismos de cooperación internacionalde apoyo a la educación superior indígena.

El peritaje antropológico y la defensa penal de imputados indígenas en La Araucanía, 2004-2011

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Roberto Anselmo Álvarez San Martín

2014-07-01

Full Text Available El presente artículo consiste en la exposición de los principales análisis realizados a partir de la sistematización de peritajes antropológicos solicitados por la Defensoría Penal Pública en la región de La Araucanía en el período 2004 – 2011, con el objeto de identificar los elementos centrales de las razones esgrimidas al recurrir a una defensa penal culturalmente pertinente. Para ello, se toman los fundamentos, las especificaciones técnicas y las justificaciones jurídicas de pericias realizadas en el período. A modo de síntesis se constata que: i en La Araucanía ha existido una subutilización de la pericia cultural en los procesos de defensa penal de imputados indígenas, ii los defensores especializados son quienes han recurrido mayormente a estas pericias, iii el principal argumento esgrimido en la solicitud de estas indagaciones ha sido el de la costumbre indígena, y iv la aprobación de las solicitudes de peritajes antropológicos ha sido justificada en cuanto que son esenciales en la construcción de la teoría del caso. En términos de desafíos actuales para la utilización de los peritajes antropológicos en la defensa de imputados indígenas se deja planteado un conjunto de interrogantes para la defensa penal indígena y las ciencias antropológica y jurídica.

Consideraciones sobre educación matemática y educación indígena en Colombia

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Aldo Iván Parra Sánchez

2014-09-01

Full Text Available Se relatan parte de los procesos educativos adelantados por pueblos indígenas colombianos, para contestar y ampliar problemáticas planteadas internacionalmente desde una perspectiva crítica en educación matemática. Mediante dos estudios de caso (departamentos de Cauca y Guainía se consiguen plantear diferentes cuestionamientos en torno a la relación de las propuestas educativas en matemáticas y el contexto sociopolítico de las comunidades indígenas, en particular se indagan las implicaciones de una educación no diferenciada que no tiene en cuenta los proyectos de resistencia cultural en medio de situaciones de conflicto armado. También se propone una reflexión sobre el papel del investigador dentro de los procesos comunitarios, que puede suscitar cambios en futuras experiencias del campo.

Consideraciones sobre educación matemática y educación indígena en Colombia

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Aldo Iván Parra Sánchez

2014-01-01

Full Text Available Se relatan parte de los procesos educativos adelantados por pueblos indígenas colombianos, para contestar y ampliar problemáticas planteadas internacionalmente desde una perspectiva crítica en educación matemática. Mediante dos estudios de caso (departamentos de Cauca y Guainía se consiguen plantear diferentes cuestionamientos en torno a la relación de las propuestas educativas en matemáticas y el contexto sociopolítico de las comunidades indígenas, en particular se indagan las implicaciones de una educación no diferenciada que no tiene en cuenta los proyectos de resistencia cultural en medio de situaciones de conflicto armado. También se propone una reflexión sobre el papel del investigador dentro de los procesos comunitarios, que puede suscitar cambios en futuras experiencias del campo.

Bravura Indômita: entre a fábula e a trama

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Sharmilla O'hana Rodrigues da Silva

2012-05-01

Full Text Available Neste artigo, analisam-se o romance Bravura Indômita, escrito por Charles Portis e publicado em 1968, e suas duas versões para o cinema, realizadas em 1969 e em 2010. Parte-se dos conceitos de fábula e trama – também conhecidos como fábula e enredo, narração e mostração, estória e discurso – que indicam que várias narrativas podem ser criadas a partir de uma única. Usam-se os estudos desenvolvidos por Seymour Chatman, Umberto Eco, Hélio Guimarães, Linda Hutcheon, Linda Seger, Ismail Xavier, André Gaudreault e François Jost para entender como estes conceitos funcionam na relação entre literatura e cinema. Para reflexão sobre os dois filmes, recorrem-se as resenhas publicadas por Isabela Boscov, Yuri Celico, Thiago M. Correia, Marcelo Hessel, André Sollito e Rubens Ewald Filho. Percebe-se que a adaptação é um processo de reconstrução textual em que o indivíduo insere suas experiências pessoais e sociais. Logo, as duas versões fílmicas de Bravura Indômita se configuram como interpretações de diferentes leitores – neste caso, os cineastas Henry Hathaway e Joel e Ethan Coen.

La Misión Indígena San Francisco Solano de Tacaaglé en las tierras fiscales de Formosa (1900-1950)

OpenAIRE

Dalla Corte, Gabriela

2013-01-01

La Misión Indígena fue inaugurada en el año 1901, en la zona del río Pilcomayo del Territorio Nacional de Formosa, precisamente al costado de la concesión paraguaya otorgada a Elisa (Elizabeth Alicia) Lynch. Desde entonces, fue trasladada, primero a Tacaaglé en 1902, donde adquirió el nombre de Misión San Francisco Solano, y posteriormente, en 1915, al riacho El Porteño. Los Misioneros Franciscanos asumieron la tarea de formar a “colonos indígenas” tobas y pilagás para la producción de azúcar...

Indústria de tabaco e cidadania: confronto entre redes organizacionais

OpenAIRE

Boeira, Sérgio Luís

2006-01-01

O artigo aborda a história da indústria de tabaco no Brasil e da formação de sua rede estratégica, bem como da rede dos atores sociais que a contrapõem. Na primeira parte, apresenta-se uma correlação entre a história da produção industrial, do consumo de tabaco e do antitabagismo. Na segunda parte são apresentados os conceitos de rede estratégica e de rede multifragmentária (antifumo), propostos para facilitar a compreensão de alguns dos múltiplos aspectos conflitivos entre as duas redes. A p...

Problemática lingüístico-educativa de los pueblos indígenas de Venezuela

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Natalia Bondarenko Pisemskaya

2009-12-01

Full Text Available En este artículo se examina la situación de los pueblos indígenas de Venezuela y de sus respectivas lenguas; se presentan los antecedentes y los alcances del Régimen de Educación Intercultural Bilingüe y se analizan las implicaciones de las políticas lingüísticas del Estado venezolano en materia lingüístico-educativa. La investigación, de tipo documental, se realizó a través de una metodología cualitativa, a partir de análisis teóricos y de una entrevista focalizada semiestructurada. Se concluye que a pesar de los esfuerzos del Estado, son los propios indígenas los que deben hacerse responsables tanto de su destino como de sus lenguas, rigiéndose por el principio de la autodeterminación, sin tanta intervención por parte del Estado.

Ciudad de migrantes, ciudad para quedarse. Prácticas culturales y relaciones institucionales de los grupos indígenas en Tijuana, México

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Olga Lorenia Urbalejo Castorena

2016-01-01

Full Text Available Se analiza la situación de los indígenas en Tijuana, quienes se distinguen por practicar la migración permanente, y que como parte de dicho proceso se han establecido en esta ciudad fronteriza, desde la que, entre la diversidad de pobladores, se observan como un grupo que comparte características, como son las prácticas culturales; un ejemplo de éstas es la celebración que realizan a sus santos patronales. Se efectúa un análisis del esta - blecimiento de los indígenas en la ciudad a través de dos ejes: las relaciones institucionales y el uso de algunas de sus prácticas. Dichas relaciones quedan mediadas por las lideresas y los líderes de las organizaciones, sin embargo, se puede suponer que no todos los indígenas pertenecen a alguna asociación, ni que éstas son representativas de todos.

Turismo rural y desarrollo territorial en espacios indígenas de México

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José Pedro Juárez Sánchez

2009-01-01

Full Text Available México es uno de los principales productores de café a escala mundial, lo que genera una gran cantidad de divisas al país. Sin embargo, es producido en su mayoría por indígenas en pequeñas plantaciones y viven en condiciones de extrema pobreza. Esta situación se ha acentuado a raíz de las crisis recurrentes del cultivo. Este estudio se realizó en cuatro municipios con plantaciones de café, ubicados en la sierra Nororiente de Puebla, México. La investigación se centró en la posibilidad de impulsar el agroturismo en espacios marginados, con población pobre e indígena. Los resultados muestran que el 80 por ciento de los entrevistados desea participar en actividades agroturísticas. Se concluye que mediante el apoyo a este tipo de proyectos por parte de las autoridades gubernamentales, el agroturismo puede representar una actividad complementaria a la producción de café que proporcione recursos económicos y que permita contribuir al incremento y calidad de la producción y, consecuentemente, a mejorar las condiciones de vida de la familia campesina.

Nanotechnology Laboratory Continues Partnership with FDA and National Institute of Standards and Technology | Poster

Science.gov (United States)

The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In

21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Examples of Graphic Enhancements Used by FDA A... (CONTINUED) DRUGS: GENERAL LABELING Pt. 201, App. A Appendix A to Part 201—Examples of Graphic Enhancements.... Examples of § 201.66 Standard Labeling and Modified Labeling Formats A. Section 201.66 Standard Labeling...

(Rexistir com imagens: considerações sobre a produção audiovisual indígena no Brasil

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Karliane Macedo Nunes

2017-01-01

Full Text Available O presente artigo trata das produções audiovisuais indígenas realizadas no Brasil, sobretudo aquelas vinculadas ao projeto Vídeo nas Aldeias, que desde o final dos anos 1980 vem promovendo oficinas de formação audiovisual em diversos territórios, incentivando o protagonismo de jovens indígenas na construção de suas imagens e narrativas. Chama a atenção a forma criativa como os jovens cineastas vem se apropriando das tecnologias de modo a produzir filmes que - para além propósito inicial de registrar e “preservar” a tradição – potencializam as possibilidades abertas pelo cinema, pondo-se a criar novas imagens, (reinventar culturas, abalar imaginários, manter-se em movimento, (rexistir.

Pueblos indígenas, Estado y Territorio en tiempos interculturales en la provincia de Salta

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Mariana Andrea Schmidt

2011-12-01

Full Text Available La configuración del Estado argentino hacia fines del siglo XIX y principios del XX tuvo como uno de sus móviles principales la eliminación, asimilación e invisibilización de los pueblos indígenas. En las últimas décadas del siglo XX, se ha pasado de una política de invisibilización y homogeneización a otra de visibilización y reconocimiento de la diversidad cultural, promoviéndose la diversidad territorial, cultural y lingüística acallada durante décadas. El objetivo del presente artículo es indagar en las características asumidas por estos procesos en la provincia de Salta. Partiendo de considerar al Chaco salteño como territorio históricamente imaginado como indígena, interesa pensar cómo juegan estos imaginarios territoriales a la hora de diseñar e implementar políticas públicas para este territorio y su población.

75 FR 28622 - FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of...

Science.gov (United States)

2010-05-21

...] FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U...: Notice of availability; request for comments. SUMMARY: As part of the second phase of the Transparency... Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and...

Atuação de incubadoras de empresas no desenvolvimento de uma indústria local de biotecnologia na área médica : estudo de caso da Fundação Biominas

OpenAIRE

Souza, Cláudio Vieira de

2010-01-01

A indústria de biotecnologia, apesar de estar vivendo um momento de progresso acelerado, enfrenta inúmeras dificuldades que tornam difícil a entrada de novas empresas, e o desenvolvimento de indústrias regionais. Novas empresas, apesar de geralmente possuírem escassez de recursos, são grandes fomentadoras da inovação, desempenhando importante papel no desenvolvimento de indústrias locais. Desta forma, um ambiente que propicie menores barreiras à entrada, que incentive a produtividade, inovaçã...

Indústrias criativas: alternativa de desenvolvimento regional | Creative industries: regional development alternatives

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Cláudia Sousa Leitão

2011-10-01

Full Text Available Resumo O presente artigo tem por objetivo apresentar uma proposta de fomento às cadeias produtivas das indústrias criativas no nordeste do Brasil, na perspectiva de uma discussão acerca de modelos alternativos de desenvolvimento regional. Para concretizar esse propósito, foi realizada uma pesquisa do tipo bibliográfica em livros, artigos de periódicos e documentos eletrônicos. O estudo inicia-se com a reflexão sobre os significados do desenvolvimento e suas conexões com a criatividade e a inovação. A pesquisa está estruturada em dois grandes eixos: o primeiro trata do conceito de indústrias criativas e do relato de suas potencialidades na geração de impactos econômicos, culturais, sociais e tecnológicos positivos na alavancagem do comércio doméstico e externo de bens e serviços criativos; o segundo apresenta uma discussão sobre desenvolvimento local e regional a partir do conceito de ‘bacia criativa’ com vistas a um novo enfoque territorial do nordeste brasileiro. A partir desses eixos, é proposto o Programa Nordeste Criativo que se constitui de duas linhas de ação fundamentais: o primeiro refere-se à estruturação e operacionalização de um o Observatório das Indústrias Criativas do Nordeste (OICNE voltado a produção e difusão do conhecimento sobre a economia criativa da região; o segundo diz respeito à criação e operacionalização dos Birôs de Negócios Criativos (BNC, ou seja, espaços físicos para o fomento de empreendimentos criativos sustentáveis e fortalecimento da cadeia produtiva das indústrias criativas. Assim, este estudo vem contribuir para a construção de um novo pensamento sobre o nordeste brasileiro. Por um lado, a institucionalização do Observatório das Indústrias Criativas se propõe a identificar o potencial criativo daquela região; do outro, os Birôs de Negócios Criativos objetivam consolidar as cadeias produtivas das indústrias criativas, enfatizando a profissionaliza

FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.

Science.gov (United States)

de Claro, R Angelo; McGinn, Karen M; Verdun, Nicole; Lee, Shwu-Luan; Chiu, Haw-Jyh; Saber, Haleh; Brower, Margaret E; Chang, C J George; Pfuma, Elimika; Habtemariam, Bahru; Bullock, Julie; Wang, Yun; Nie, Lei; Chen, Xiao-Hong; Lu, Donghao Robert; Al-Hakim, Ali; Kane, Robert C; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T; Pazdur, Richard

2015-08-15

On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that received all four expedited programs of the FDA: Fast-Track designation, Breakthrough Therapy designation, Priority Review, and Accelerated Approval. Both approvals were based on overall response rate (ORR) and duration of response (DOR) in single-arm clinical trials in patients with prior treatment. In MCL (N = 111), the complete and partial response rates were 17.1% and 48.6%, respectively, for an ORR of 65.8% [95% confidence interval (CI), 56.2%-74.5%]. The median DOR was 17.5 months (95% CI, 15.8-not reached). In CLL (N = 48), the ORR was 58.3% (95% CI, 43.2%-72.4%), and the DOR ranged from 5.6 to 24.2 months. The most common adverse reactions (≥ 30% in either trial) were thrombocytopenia, diarrhea, neutropenia, bruising, upper respiratory tract infection, anemia, fatigue, musculoskeletal pain, peripheral edema, and nausea. ©2015 American Association for Cancer Research.

Taenia saginata Goeze, 1872 (Platyhelminthes: Cestoda: Taeniidae en un indígena de Tierra del Fuego, Chile

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Eduardo I. Faúndez

2015-06-01

Full Text Available Se entrega el primer registro del céstodo Taenia saginata en un indígena de Tierra del Fuego (Patagonia chilena, correspondiente al año 1902. Se discute la importancia del registro y se entregan ilustraciones del ejemplar.

Política ambiental y territorios indígenas de Sonora

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Diana Luque

2012-01-01

Full Text Available La política ambiental en México ya es parte de la agenda de seguridad nacional, sin embargo, uno de sus instrumentos de planeación clave es el OET (Ordenamiento Ecológico del Territorio, el cual no ha logrado el impacto previsto. Se propone a los pueblos y territorios indígenas de Sonora como sector estratégico para la implementación de los OET, para lo cual se considera necesario profundizar en su problemática actual. Por ello, se realiza un análisis socioambiental de los complejos bioculturales de Sonora, a partir del marco de reflexión de la ecología política y la perspectiva biocultural. Esto se logra a partir de un análisis interdisciplinario donde se conjugan epistemologías y metodologías de los campos de las ciencias sociales y de la ecología. El análisis socioambiental se organiza a partir de dos grandes temas: la territorialidad y la comunidad indígena contemporánea. Se concluye que el formato actual de los OET es poco operativo, por lo que se dan recomendaciones para eficientar su implementación. Por último, se resalta la importancia de la atención de los complejos bioculturales, en primera instancia como un tema de justicia ambiental, así como por su capacidad para incidir a favor de los temas globales ambientales, como el cambio climático y la disponibilidad y calidad del agua.

A revitalização da indústria de defesa brasileira: análise da alternativa Cooperação Sul-americana/européia

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Renato Peixota Dagnino

2010-05-01

Full Text Available No Brasil, assiste-se a formação de uma policy network que busca a revitalização da indústria de defesa. O foco do presente trabalho é analisar uma alternativa em discussão no interior dessa rede para revitalizar tal indústria por meio de uma cooperação entre os países sul-americanos e europeus. Apesar da informação sobre o setor ser escassa e controversa, foi possível realizar uma análise dos atores envolvidos, dos mercados, capacidades produtivas, dos principais benefícios e ameaças que apresenta essa cooperação. O artigo sinaliza a necessidade de melhor avaliar esses potenciais benefícios e os impactos de uma revitalização da indústria de defesa nacional.

Créer des emplois pour combler l'absence de milieu en Inde | CRDI ...

International Development Research Centre (IDRC) Digital Library (Canada)

21 juin 2016 ... Les chercheurs ont aussi observé que l'expansion de l'emploi dans des secteurs autres que l'agriculture était étroitement liée à l'expansion de l'éducation. L'Inde doit s'attacher à offrir une meilleure instruction dans ses villages, afin que les travailleurs éventuels puissent acquérir les compétences de base ...

Acidentes envolvendo indígenas brasileiros atendidos em serviços de urgência e emergência do Sistema Único de Saúde

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Edinilsa Ramos de Souza

Full Text Available Resumo Foram analisados os acidentes ocorridos com indígenas brasileiros atendidos em serviços de urgência e emergência do Sistema Único de Saúde (SUS. Os dados provêm do Viva Inquérito de 2014, que incluiu 86 serviços de 24 capitais e do Distrito Federal. Caracterizou-se o perfil sociodemográfico dos indígenas, o evento e o atendimento. A maioria dos atendidos era do sexo masculino e tinha entre 20-39 anos. Acidentes de transporte e quedas foram os principais motivos dos atendimentos. O uso de bebida alcoólica foi informado por 5,6% dos atendidos. Nos acidentes de transporte esse uso sobe para 19,1%; 26,1% entre condutores e 22,8% nos motociclistas. Houve diferença estatística entre os sexos em relação à faixa etária, deficiência, local de ocorrência do evento, evento relacionado ao trabalho e condição da vítima no acidente de transporte. Destaca-se a importância de dar visibilidade aos acidentes com indígenas e de envolvê-los na prevenção desses eventos. A fidedignidade desses dados depende do seu adequado preenchimento nos sistemas de informações sobre saúde de indígenas.

Exploratory multivariate analysis by example using R

CERN Document Server

Husson, Francois; Pages, Jerome

2010-01-01

Full of real-world case studies and practical advice, Exploratory Multivariate Analysis by Example Using R focuses on four fundamental methods of multivariate exploratory data analysis that are most suitable for applications. It covers principal component analysis (PCA) when variables are quantitative, correspondence analysis (CA) and multiple correspondence analysis (MCA) when variables are categorical, and hierarchical cluster analysis.The authors take a geometric point of view that provides a unified vision for exploring multivariate data tables. Within this framework, they present the prin

Exploratory Bi-factor Analysis: The Oblique Case

OpenAIRE

Jennrich, Robert L.; Bentler, Peter M.

2011-01-01

Bi-factor analysis is a form of confirmatory factor analysis originally introduced by Holzinger and Swineford (1937). The bi-factor model has a general factor, a number of group factors, and an explicit bi-factor structure. Jennrich and Bentler (2011) introduced an exploratory form of bi-factor analysis that does not require one to provide an explicit bi-factor structure a priori. They use exploratory factor analysis and a bi-factor rotation criterion designed to produce a rotated loading mat...

A clinical plan for MDMA (Ecstasy) in the treatment of posttraumatic stress disorder (PTSD): partnering with the FDA.

Science.gov (United States)

Doblin, Rick

2002-01-01

The FDA and the Spanish Ministry of Health have concluded that the risk/benefit ratio is favorable under certain circumstances for clinical studies investigating MDMA-assisted psychotherapy. Both agencies have approved pilot studies in chronic posttraumatic stress disorder (PTSD) patients who have failed to obtain relief from at least one course of conventional treatment. These studies, the only ones in the world into the therapeutic use of MDMA, are being funded by a nonprofit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org). A rationale is offered explaining why MAPS chose to focus its limited resources on MDMA, and also on PTSD patients. A Clinical Plan is elaborated for the conduct of the "adequate and well-controlled" trials necessary to evaluate the safety and efficacy of MDMA-assisted psychotherapy for PTSD, with the studies estimated to cost about 5 million dollars and to take about five years. The Clinical Plan has been developed, in part, through analysis of the studies conducted by Pfizer in its successful effort to have Zoloft approved by the FDA for use with PTSD patients, and through review of transcripts of the FDA's Psychopharmacologic Drugs Advisory Committee meeting that recommended approval of Zoloft for PTSD.

No solo crear la memoria de nosotros como pueblos indígenas, sino enseñar a ver esa memoria

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Marisol Calambás

2014-09-01

Full Text Available Marisol Calambás Soscué presenta su recorrido creativo como una búsqueda de nuevas técnicas y formas plásticas para expresar la memoria ancestral del pueblo Nasa al que pertenece. Es necesario escapar del estancamiento artificial impuesto por el mercado turístico que etiqueta las obras indígenas como ‘artesanías’ y exige la repetición de patrones supuestamente ancestrales. La creatividad de los artistas contemporáneos indígenas, muestra Marisol, fluye transformando constantemente los canales de comunicación de la memoria. Es necesario, por tanto, educar la mirada del público para que aprenda a ver dichas transformaciones. 

Densité de population et systèmes agricoles en Inde

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François DURAND-DASTÈS

1986-12-01

Full Text Available II est classique de considérer que la densité de population et la productivité de l'agriculture sont fortement liées l'une à l'autre en Inde. La réalité de cette relation est vérifiée par la technique de la régression linéaire. La prise en compte des résidus permet de mettre en valeur des spécificités régionales, dont l'explication est esquissée par la prise en compte de l'histoire du peuplement et des structures sociales.

Migración retornada y juventud indígena (Zacualpa, Guatemala)

OpenAIRE

Ricardo Falla, S.J

2008-01-01

En este artículo resumo una investigación que acaba de ser publicada en forma de libro sobre la juventud indígena y la migración retornada en Zacualpa, Guatemala.1 De entrada advierto que los resultados de esta investigación reflejan la situación de principios de 2007. Ya se estaba enrareciendo entonces el ambiente con deportaciones masivas en los Estados Unidos, como fue la de las fábricas Swift el 12 de diciembre de 2006. Pero el repunte del número de deportaciones de2007 no se había sentid...

Gestionando la ciudadanía pluricultural: la escuela indígena en Chiapas ante los derechos culturales

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Victoria Borrell Velasco

2016-01-01

Full Text Available En una relación intercultural históricamente asimétrica, las formulaciones que afectan a las oportunidades educativas de los pue - blos originarios en el sistema público de educación se enfrentan a múl - tiples obstáculos. La enculturación en las escuelas indígenas dificulta el desarrollo de identidades múltiples homologables realmente funcio - nales para la construcción de una ciudadanía pluricultural, ya que se fomenta la tolerancia hacia pedagogías colonizadoras. Las tendencias que se originan a través de estos procesos educativos neocolonialistas, que atentan contra los derechos culturales reconocidos en las leyes, son conflictivas y contradictorias, tanto las que refuerzan la identidad étni - ca asumiendo una posición subalterna como las que la rechazan bus - cando vías de asimilación. En la resolución de este dilema apenas existe presencia indígena, ya que tradicionalmente, a pesar de los desarrollos normativos en el marco de los derechos culturales, los pueblos origina - rios quedan relegados de las consideraciones y de la toma de decisiones relacionadas con la educación. Este trabajo de investigación pretende evidenciar tanto las prin - cipales actuaciones del sistema educativo nacional en las escuelas de población originaria, ante el reto de los derechos culturales, como identificar las respuestas de los pueblos indígenas en relación con estos derechos en el estado de Chiapas.

Ecología y Salud Indígena

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Alberto Pinzón Sánchez

1989-09-01

Full Text Available

Uno de los pocos estudios hechos en el país desde el punto de vista de la Salud Pública y realizado en terreno sobre población indígena, es el estudio médico-antropológico de la Amazonia Colombiana realizado por el Doctor Ney Guzmán Gómez, de la Universidad del Valle en 1968. (1

A pesar de algunas deficiencias en el análisis antropológico, es el primer buen estudio de ese tipo, en donde se combinan los datos cualitativos y cuantitativos del nivel de salud, de un Universo Poblacional de 2.478 personas de las cuales 2.158 (87% eran indígenas, moradores de las riberas de los grandes ríos del trapecio amazónico; Putumayo, Caraparaná, Igaraparaná, Pupuña, Icatué y perteneciente a los grupos étnicos: Witotos, Borás y Ticunas.

Los indicadores más relevantes y que nos recuerdan la situación del país a comienzos de este siglo, son:

1. Pirámide poblacional con predominio de menores de 15 años.(54%
2. Elevadas tasas de natalidad 62 x 1000
3. Elevada tasa de mortalidad general 20 x 1000 – Con una elevada tasa de mortalidad de menores de una añ0 87 x 1000
4. Edad media al morir ................................25,5 años
5. Las principales causas de mortalidad:
– Gastroenteritis ...................16%
– Tuberculosis ...............10%
– Anemia.......... 6%
– Colitis. ........................... 6%
– Accidentes de selva............................. 6%
– Bronconeumonía................................. 4%
– Sarampión.................................... 2%
6. Las principales causas de morbilidad clínica fueron:
– Poli parasitismo intestinal................................... 30%
– Enfermedades respiratorias............................14%
– Enfermedades de la piel ............................. 6%
– Avitaminosis y anemia.............................. 6%
– Gastroenteritis...................................4

Does the FDA have regulatory authority over adult autologous stem cell therapies? 21 CFR 1271 and the emperor's new clothes

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Freeman Michael

2012-03-01

Full Text Available Abstract FDA has recently asserted that many autologous cell therapies once considered the practice of medicine are in fact drugs. These changes began with the creation of new sections of 21 CFR 1271 and a subsequent one word change where the FDA, without public commentary, altered a single word in its regulatory language regarding cell and tissue based therapies that asserted the authority to classify autologous tissue as drugs. The bright line between medical care and drug production can be delineated in many ways, but a simple metric that defines the dichotomy is the consent status of the patient. In healthcare, a patient can either be consented individually for a medical procedure or exposed to an unconsented risk where regulatory assurances are already in place. These new FDA policies apply rules meant to keep drugs safe in a drug factory (unconsented mass production risks to individually consented surgical procedures. We argue that there is little societal benefit to these changes and that they are already stifling medical innovation.

Animal cysticercosis in indigenous Brazilian villages Cisticercose animal em aldeias indígenas brasileiras

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Samuel Carvalho de Aragão

2010-06-01

Full Text Available Sanitary inspection of beef and pork meat has been the major tool for diagnosing animal cysticercosis and for preventing taeniasis in Brazil. The indigenous villages Jaguapiru and Bororo are located close to the urban area of the municipality of Dourados in the State of Mato Grosso do Sul, Brazil, where precarious basic sanitation conditions are observed. Both cattle and pigs are raised for self-consumption of meat and milk as well as for sale on the external market, generally without official sanitary inspection. In this study, 96 bovine carcasses and 117 pig blood serum samples from animals raised in these indigenous villages were evaluated for the presence of metacestodes by postmortem evaluation, and anti-Taenia sp. antibodies were investigated using the indirect ELISA test. Metacestode forms were observed in 18.7% of the bovine carcasses, and 9.4% of the pig serum samples were positive for anti-Taenia sp. antibodies. The occurrence of animal cysticercosis in the villages may favor the occurrence of this zoonosis in the indigenous populations. Enforcement of proper slaughter and sanitary inspection conditions are urgently needed for controlling the taeniasis-cysticercosis complex among the indigenous population.A inspeção sanitária da carne bovina e suína tem sido a principal forma diagnóstica da cisticercose animal e da prevenção da teníase no Brasil. As aldeias indígenas Jaguapirú e Bororó estão localizadas próximo à área urbana do município de Dourados-MS, com condições precárias de saneamento básico, onde bovinos e suínos são criados como fonte de alimento para consumo próprio, bem como para comercialização externa, geralmente sem inspeção sanitária oficial. Neste estudo, 96 carcaças bovinas e 117 amostras de soro de suínos, criados nas aldeias indígenas, foram avaliadas para a presença de formas metacestóides à inspeção sanitária e de anticorpos anti-Taenia sp. ao teste ELISA, respectivamente

Luces y sombras en la historia de los grupos indígenas en Sonora, siglos XIX-XXI. Panorama historiográfico

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Zulema Trejo Contreras

2015-01-01

Full Text Available en este artículo se presenta un análisis panorámico respecto a la historiografía de los grupos indígenas mayo, yaqui y ópata; el objetivo es conocer cómo ha evolucionado la forma en que se les ha estudiado. Se destaca la concepción dualista de los autores respecto a las etnias, la inserción de los textos revisados en el contexto historiográfico nacional y la manera como han ido cambiando los temas de estudio en relación con la historia de los grupos indígenas de Sonora.

Características estruturais, relacionais e gerenciais na cadeia de suprimentos de um condomínio industrial na indústria automobilística

OpenAIRE

Pires,Sílvio Roberto Ignácio; Sacomano Neto,Mário

2010-01-01

Nas últimas décadas, a contribuição da indústria automobilística tem sido muito representativa em termos de inovações na gestão da cadeia de suprimentos, tais como aquelas contempladas nos modelos de consórcio modular e de condomínio industrial. Este artigo apresenta os resultados de uma pesquisa envolvendo diferentes configurações na estrutura de relacionamento entre uma montadora de automóveis e alguns de seus fornecedores, em uma cadeia de suprimentos da indústria automobilística que utili...

Contribuciones de la educación popular para la Organización Comunitaria. Una experiencia con mujeres indígenas Purépechas.

OpenAIRE

Calvario Miramontes, Ignacio

2014-01-01

El presente estudio analiza desde una postura pedagógica, algunos procesos de organización comunitaria de grupos indígenas, frente a las condiciones agroalimentarias generadas a partir de las tendencias del “Desarrollo” manifestadas en México y en el marco del neoliberalismo. Para esta investigación se tomó el caso de un grupo de mujeres indígenas de la comunidad de Santo Tomás, en el estado de Michoacán; que son miembros de una asociación civil.

Mujeres indígenas, gobierno y comunidad: El caso de mujeres tarahumaras en Ciudad Juárez, Chihuahua

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Martha Estela Pérez García

2016-01-01

Full Text Available La situación de las mujeres indígenas en Chihuahua se caracteriza por la marginación, pobreza y desigualdad. Por esta razón, algunos(as miembros de la etnia rarámuri obligados por las necesidades más elementales, emigran con sus familias a las principales ciudades de la entidad. En el caso específico de la comunidad indígena asentada en Ciudad Juárez, Chihuahua, encontramos que son mujeres quienes dirigen las tareas de gobierno, rol tradicionalmente asignados a los hombres. El objetivo de este artículo es realizar un acercamiento de la participación femenina en el gobierno de la colonia tarahumara, con el propósito de conocer cómo se genera esta participación, sus liderazgos y las formas de resolución de sus problemas al interior de la comunidad. Para este propósito se realizaron entrevista con representantes de la comunidad y sus dos gobernadoras, además de un grupo focal con la presidenta y un grupo de mujeres. Los resultados de esta investigación mostraron dos cuestiones significativas: la situación de extrema vulnerabilidad en que viven las indígenas en el entorno urbano y que el gobierno femenino usa estrategias apegadas al rol de género para mantener el orden, el liderazgo y mejorar la calidad de vida de su comunidad.

Brechas de equidad: análisis de la información sociodemográfica de la población indígena

OpenAIRE

Stella Maris-Orzuza

2015-01-01

Objetivo: caracterizar socio-demográficamente a la población indígena residente en la provincia de Santa Fe de Argentina. Materiales y Métodos: se realizó un análisis estadístico descriptivo de las variables investigadas en la población indígena residente en la provincia de Santa Fe en Argentina, con base en la información recopilada en los Censos Nacionales de Población, Hogares y Viviendas 2001 y 2010 en la República Argentina. La población fue indagada a través de encuestas domiciliarias. ...

Inovação em serviços : estudo de casos em uma organização da indústria hoteleira brasileira

OpenAIRE

Claudia Fernanda Franceschi Klement

2007-01-01

Dentre as estratégias utilizadas pelas organizações, inclusive prestadoras de serviço, no intuito de fazer frente à concorrência e manter-se competitivas no mercado, encontra-se a busca constante da inovação. Muito já se estudou sobre inovação em indústrias manufatureiras. Utterback (1994) estudou diferentes indústrias, incluindo as de bens não-montados (como o vidro), no intuito de compreender como se dá o processo de inovação e como acontece o design dominante. Henderson e Clark (1990) busc...

Indústria fonográfica e a Nova Produção Independente: o futuro da música brasileira?

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Leonardo De Marchi

2008-09-01

Full Text Available Neste artigo, relaciona-se a rápida consolidação da indústria fonográfica independente no Brasil, ou Nova Produção Independente, às transformações promovidas pelas novas tecnologias da informação e da comunicação e pela recente economia do entretenimento. Argumenta-se que o surgimento dessas empresas se dá não por uma “crise” da indústria de música, mas pela complexificação da cadeia produtiva da fonografia, reorganizada pelo surgimento de novas tecnologias e hábitos de consumo de gravações sonoras na era digital. Palavras-chave: Indústria fonográfica brasileira; produção independente; novas tecnologias da informação e da comunicação. ABSTRACT In the article, the fast consolidation of the Brazilian phonographic independent industry, or New Independent Production, is related to the transformations promoted by the new information and communication technologies and the new entertainment economy. As argued, the appearance of these companies does not result from a “crisis” of the music industry, but from the complexification of the phonographic productive chain, reorganized by the appearance of new technologies and habits of consumption of sound recordings in the digital era. Keywords: Brazilian phonographic industry; indies; new information and communication technologies.

Les indéterminations augustiniennes. Gilson’s reading of the Augustinian thought

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Federico Chiappetta

2016-02-01

Full Text Available Étienne Gilson ha dedicato numerosi lavori alla riflessione filosofica di Agostino e alla tradizione agostiniana medievale. Lo storico francese ha cercato di rilevare i tratti principali e lo spirito della filosofia agostiniana e si è interessato ai complessi sviluppi dell’agostinismo. Gilson ha introdotto la categoria storiografica delle indeterminazioni agostiniane per esprimere la complessità del pensiero di Agostino: questa filosofia sarebbe caratterizzata da numerose questioni irrisolte dovute al tentativo agostiniano di dare alla filosofia neoplatonica un significato cristiano. In alcuni suoi lavori, Gilson ha sostenuto che la convergenza fra queste indeterminazioni e alcuni sistemi di pensiero, giunti nell’occidente latino fra il XII e il XIII secolo, avrebbe ispirato la cosiddetta riforma tomista. A questo proposito è molto importante un articolo del 1926, Pourquoi saint Thomas a critiqué saint Augustin. L’articolo mostra l’importanza delle indeterminazioni negli studi dello storico: questa intrinseca incompletezza dell’opera di Agostino consentirebbe di comprendere non solo gli sviluppi del pensiero agostiniano, ma anche il pensiero di Tommaso d’Aquino e della scuola domenicana. L’articolo tratteggia, inoltre, l’interpretazione di Gilson del pensiero agostiniano in relazione all’adesione dello storico alla filosofia neoscolastica. Étienne Gilson devoted several studies to Augustine’s thought and to medieval Augustinian tradition. The French historian attempted to paint the main tracts and the spirit of Augustine’s philosophy and he studied the complex developments of Augustinianism. Gilson introduced the historical category of the indéterminations augustiniennes to express the problematic nature of Augustine’s thought: this philosophy would be characterized by several unexplained questions due to the Augustinian attempt to attach a Christian meaning to the Neoplatonic philosophy. In numerous of his works

Le pétrole en Inde Oil in India

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Diab E.

2006-11-01

Full Text Available L'Inde est un pays riche en ressources énergétiques. En ce qui concerne le pétrole, les réserves prouvées sont déjà abondantes, mais certains pensent qu'il reste un potentiel très important à découvrir, le pays étant un des moins explorés du monde. L'ouverture récente des industries de l'énergie aux capitaux privés et étrangers devrait accélérer le développement de l'exploration, du raffinage et de la pétrochimie. Mais, bien que de nombreux projets aient été approuvés par le gouvernement, la réalisation ne suit pas dans tous les cas, en raison de conditions qui ne sont pas toujours jugées attrayantes par les investisseurs potentiels. Malgré tout, certains pensent que l'Inde sera une puissance égale sinon supérieure à la Chine et qu'elle soutient déjà la comparaison avec les dragons du Sud-Est asiatique. India is a country that is rich in energy resources. Concerning oil, proven reserves are already abundant, but there are some who think that a very large potential remains to be discovered, since the country is one of the least throughly explored in the world. The recent opening up of energy industries to private and foreign capital should speed up the development of exploration, refining and petrochemicals. However, even if numerous projects were to be approved by the Government, actually carrying them out does not always ensue because of conditions that are not always judged to be attractive by potential investors. Despite all this, there are some who think that India will be a power equal to if not greater than China and one that is already upholding the comparison with the Southeast Asian dragons.

FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster

Science.gov (United States)

By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.

Interculturalidad y derecho a la educación de la niñez indígena jornalera migrante

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Lourdes Consuelo Pacheco Ladrón de Guevara

2016-01-01

Full Text Available Niños y niñas de pueblos indígenas trabajan en campos agrícolas de acuerdo con su edad y género aunque deberían estar en la escuela recibiendo educación de calidad en su propia lengua. Desde 1999, con la Modalidad Educativa Intercultural para la Población Infantil Migrante se estableció la interculturalidad como orientación educativa para la niñez indígena agrícola migrante, que se retomó posteriormente en el Programa Educación Primaria para Niñas y Niños Migrantes. En este artículo se analizan las acciones sobrea educación intercultural dirigida a esta población a partir del análisis de las acciones establecidas por parte del sector educativo.

Etnogénesis de un grupo indígena del Brasil central Ethnogenesis of an indigenous group of central Brazil

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Marlene Castro Ossami de Moura

2008-06-01

Full Text Available El texto analiza el proceso de emergencia étnica de un grupo de indígenas llamados tapuios , que habitan el Área Indígena Carretão, situada entre los municipios de Nova América y Rubiataba, en el estado de Goiás, Brasil. Este grupo es fruto de una política de aldeamentos indígenas surgida en Brasil desde el comienzo de la colonización en el siglo XVI hasta mediados del siglo XIX. En el estado de Goiás fueron construidos cerca de 20 aldeamentos indígenas entre los años de 1741 y 1872. Los tapuios son descendientes de cuatro grupos indígenas que fueron reubicados en el aldeamento Carretão, construido en 1788 por la Corona portuguesa y desactivado al final del siglo XIX. Ocultos en el escenario nacional, con la extinción de ese aldeamento , los tapuios van adquirir visibilidad en la década de 1980 al nacer un nuevo grupo orgánico de individuos, respaldados por la lucha de recuperación de su territorio y de su identidad étnica, dos pilares de afirmación del grupo.This text analyses the process of ethnic emergence of an indigenous group called tapuios that inhabits the Indigenous Area Carretão, located between the districts of Nova América and Rubiataba, in the state of Goiás, Brazil. This group is the outcome of a settlement policy promoted in Brazil since the beginning of the colonization in the 16th century, until early 19th century. Approximately 20 indigenous settlements were built in the state of Goiás between the years 1741 and 1872. The tapuios are descendents of four indigenous groups who were moved to the Carretão indian settlement, constructed by the royal Portuguese authorities in 1788 and deactivated at the end of the nineteenth century. Hidden in the Brazilian national scene, since the settlement was extinct, the tapuios , since the 1980s, have regained visibility by the birth of a new native group of individuals, sustained by their fight to regain their territory and to recuperate their ethnic identity, two

Regulatory challenges in manufacturing of pancreatic islets.

Science.gov (United States)

Linetsky, E; Ricordi, C

2008-03-01

At the present time, transplantation of pancreatic islet cells is considered an experimental therapy for a selected cohort of patients with type 1 diabetes, and is conducted under an Investigational New Drug (IND) application. Encouraging results of the Edmonton Protocol published in the year 2000 sparked a renewed interest in clinical transplantation of allogeneic islets, triggering a large number of IND applications for phase I clinical trials. Promising results reported by a number of centers since then prompted the Food and Drug Administration (FDA) to consider the possibility of licensing allogeneic islets as a therapeutic treatment for patients with type 1 diabetes. However, prior to licensure, issues such as safety, purity, efficacy, and potency of the islet product must be addressed. This is complicated by the intricate nature of pancreatic islets and limited characterization prior to transplantation. In this context, control of the manufacturing process plays a critical role in the definition of the final product. Despite significant progress made in standardization of the donor organ preservation methods, reagents used, and characterization assays performed to qualify an islet cell product, control of the isolation process remains a challenge. Within the scope of the FDA regulations, islet cells meet the definition of a biologic product, somatic cell therapy, and a drug. In addition, AABB standards that address cellular therapy products apply to manufacturing facilities accredited by this organization. Control of the source material, isolation process, and final product are critical issues that must be addressed in the context of FDA and other relevant regulations applicable to islet cell products.

Etnomatemáticas indígenas y formación docente: una experiencia en Costa Rica a través del modelo MOCEMEI

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María Elena Gavarrete Villaverde

2015-01-01

Full Text Available Este artículo expone la evolución y resultados de una investigación desarrollada con docentes de primaria que trabajan en entornos indígenas en Costa Rica. Posee un doble objeto de estudio: las etnomatemáticas de tres grupos étnicos y la formación docente en etnomatemáticas dentro de un modelo intercultural. Los fundamentos teóricos del estudio se basan en las etnomatemáticas, la enculturación matemática y el aprendizaje a través de proyectos; así como también posee unos fundamentos empíricos que están constituidos por cuatro sub-estudios, los cuales consistieron en un diagnóstico de carácter etnológico realizado a tres grupos étnicos de Costa Rica, así como también tres diagnósticos en los cuales participaron: 30 profesionales que trabajan en temas de educación y cultura, 69 docentes de educación primaria que trabajan en entornos indígenas y 11 profesionales en pedagogía. Con los resultados de los sub-estudios se estableció un Curso de Formación Docente basado en Etnomatemáticas Indígenas, específico para quienes trabajan en estos entornos. La experiencia de implementación del curso se evaluó a través de un modelo etnográfico participativo y generó evidencias de la formación docente a través de un portafolio y un microproyecto curricular basado en etnomatemáticas indígenas. Dicha evaluación dio lugar a proponer un Modelo de Formación Docente basado en Etnomatemáticas Indígenas. Y se aportan elementos de discusión acerca de la pertinencia cultural y la formación docente, así como acerca de la relación entre el conocimiento cultural y el conocimiento matemático escolar.

Considering the Future of Pharmaceutical Promotions in Social Media Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

Science.gov (United States)

Carpentier, Francesca Renee Dillman

2016-02-09

This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim's article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim's rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA's attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media. © 2016 by Kerman University of Medical Sciences.

Exploratory wine consumer behavior in a transitional market: The case of Poland

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Renata Schaefer

2018-06-01

Full Text Available This paper investigates exploratory behavior among wine consumers in Poland where the country's wine culture is in a state of rapid change. This study investigates the extent to which demographics, values, and wine preferences relate to exploratory behavior.Data obtained from 198 Polish wine consumers was used in the analysis. Exploratory behavior was measured using the VARSEEK scale adapted to wine. Other measures included the Schwartz Value Inventory, wine knowledge and involvement, and measures relevant for wine purchasing behavior. Demographic variables were also used to profile consumers.The findings show that Polish wine consumers’ level of exploratory behavior is not related to demographics, but is influenced by personal values. The consumers who were most likely to engage in exploratory behavior valued creativity, fun, and risk taking and were less concerned about behaving properly. They also had more global outlook as they were more likely to purchase wine in other countries and desired more wines from regions outside Poland.The findings are useful for wine marketers when developing strategies for wine consumers in transitional markets based on their unique needs and expectations.This is the first known research conducted in Poland focusing on wine consumers’ exploratory behavior and subsequent wine preferences. Keywords: Polish wine market, Consumer behavior, Exploratory behavior, Consumer segmentation

21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false When does FDA have to issue a decision on an appeal? 1.405 Section 1.405 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal...

2016 in review: FDA approvals of new molecular entities.

Science.gov (United States)

Griesenauer, Rebekah H; Kinch, Michael S

2017-11-01

An overview of drugs approved by FDA in 2016 reveals dramatic disruptions in long-term trends. The number of new molecular entities (NMEs) dropped, reflecting the lowest rate of small-molecule approvals observed in almost five decades. In addition, the pace of industry consolidation slowed substantially. The impact of mergers and acquisitions decreased the total number of organizations with past approval experience and continued research and development (R&D) activities to 102, divided evenly between more established pharmaceutical and newer biotechnology companies. Despite these substantial differences, the industry continued to pursue regulatory incentives, as evidenced by a continued increase in the fraction of NMEs approved using an orphan or priority designation, and almost all oncology drugs approved in 2016 utilized these mechanisms. Copyright © 2017 Elsevier Ltd. All rights reserved.

Educacion y salud indígena: preámbulo a un futuro ciudadano.

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Edgar Merchán Hamann

2012-03-01

Full Text Available Los autores se refieren a la presencia de estudiantes indígenas en las universidades brasileñas, que constituye objeto de críticas y debates. Los indicadores de salud en las comunidades indígenas muestran las desventajas e inequidades acumuladas al cabo de siglos de exclusión. Delante de este cuadro, los autores hacen un contraste entre las estrategias posíbles de “perdón y olvido “ o de “justicia y reparación”. De la formulación de políticas de protección y garantía de derechos hasta su efectivación, hay un recorrido complejo y, a veces, azaroso. Siempre habrá presiones y, ocasionalmente, abusos y distorciones que son habilmente aprovechados por los enemigos de la política pública y defensores del Estado mínimo. Los autores creen que deben ser fomentados y creados espacios de diálogo para la realización de debates que contribuyan a superar las grandes dicotomías y tensiones dialécticas entre: aculturación versus preservación; etnología tradicional versus antropología en la multiculturalidad; etnopolítica versus resistencia étnica; reconocimiento versus reificación excluyente; identidad hegemónica de nación versus identidades colectivas particulares, entre otros.

El proceso de incorporación política de los sectores indígenas en el Ecuador. Pachakutik, un caso de estudio

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Francisco SÁNCHEZ LÓPEZ

2009-11-01

Full Text Available RESUMEN: Las élites y el sistema político ecuatoriano han, tradicionalmente marginado, la integración y la participación en el proceso de toma de decisiones de los indígenas aunque este sector de la población formara parte de la etapa fundacional de la sociedad ecuatoriana. En las tres últimas décadas la situación se ha ido transformando y, paralelamente al proceso de democratización experimentado por el sistema político en su conjunto, los indígenas han comenzado a organizarse y se han ido convirtiendo en un actor con gran capacidad de presión en la vida política del país. Este trabajo reflexiona acerca del proceso de incorporación política de los indígenas en el marco institucional del Ecuador y, en particular, analiza el período que abarca desde la utilización de "modos alternativos de acción política" hasta su integración a las instituciones a partir del empleo de los instrumentos de "participación política" del sistema político. En este marco se analiza el papel desempeñado las organizaciones indígenas como la Confederación de Nacionalidades Indígenas del Ecuador (CONAIE y por el Movimiento de Unidad Plurinacional Pachakutik-Nuevo País (MUPP-NP. La hipótesis principal de este trabajo es que el proceso de modernización rural llevado a cabo desde el Estado, la iglesia, las organizaciones no gubernamentales (ONG's y los organismos internacionales ha facilitado la incorporación del sector indígena campesino al sistema político a través del desarrollo organizativo de las comunidades.ABSTRACT: Elites and political system in Ecuador have traditionally marginalized integration and participation in process of decision-marking of indigenous people, even if this sector of population were part of the founders of ecuatorian society. During the last three decades, situation has changed because indigenous people start to be organized and has became in important actor with incidence in political life. This work focuses

New Advantage 24 contraceptive gel claims 24-hour effectiveness. But proposed FDA rule could put N-9 products to the test.

Science.gov (United States)

1995-04-01

Advantage 24 is a new contraceptive gel that makes use of bioadhesive technology to offer 24 hours of protection relying on the spermicide nonoxynol-9 (N-9) in lower concentrations. If a proposed US Food and Drug Administration (FDA) rule is enforced N-9 may be examined closely. The manufacturer, Whitehall-Robins Healthcare in New Jersey, stopped production of the Today contraceptive sponge because of the costs of complying with FDA standards. The Advantage 24 gel costs twice as much as the sponge. It is made in Switzerland and distributed by an Illinois company. Any vaginal contraceptive containing N-9 would be approved by the FDA as long as it complied with guidelines laid down in an FDA monograph. However, the registration of the gel could not be confirmed. The product uses a bioadhesive technology concept that natural substances adhere to epithelial and mucosal tissues in the body. Polycarbofil is mixed with water, N-9, and mineral oil to create an emulsion that allows for a time-release mechanism, but at any given time only 2 mg of N-9 is available to kill sperm. The final formula for Advantage 24 is 52.5 mg per dose. Too much N-9 can be toxic, as demonstrated by the Today sponge, which contained 1000 mg of N-9. In Kenya prostitutes using it frequently experienced 3 times as many genital lesions as those using a placebo. A study of Advantage 24 by a Miami laboratory involved 250 women, 22-45 years old, who had had prior tubal ligations. When the gel was applied 15-30 minutes before intercourse the efficacy rate was 98%; it was 91% for those applying it 12 hours before; and it was 86% when the gel was applied 24 hours ahead of time. FDA compliance officers are intrigued about the claim that the gel lasts 24 hours. However, if the claim is held up by research data, women will have an easily available, portable, efficient, aesthetic, and highly effective contraceptive.

Discriminación y prejuicios de jóvenes sonorenses hacia el migrante indígena

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Jesús Francisco Laborín Álvarez

2012-01-01

Full Text Available Los grupos culturales del sur de México que recorren grandes distancias para trabajar como asalariados o jornaleros en las diversas regiones agrícolas del norte se ven expuestos a situaciones de rechazo y marginación por parte de una cultura mestiza receptora. En función de lo señalado, y con una visión psicosocial, el objetivo del trabajo de investigación fue determinar las dimensiones particulares que presentan los jóvenes sonorenses en términos del prejuicio hacia los migrantes indígenas que arriban al estado de Sonora. Algunos de los resultados indican una estructura factorial del constructo de tres dimensiones (oposición al contacto, amenaza y rechazo y diferencias culturales. En cuanto a la comparación de los factores por variables atributivas, se observaron diferencias por sexo y tipo de ciudad. Podemos concluir que los jóvenes sonorenses poseen un carácter ambivalente y una expresión sutil del prejuicio que manifestaron hacia el migrante indígena.