WorldWideScience

Sample records for fda exploratory ind

  1. Drugs@FDA: FDA Approved Drug Products

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  2. 21 CFR 312.22 - General principles of the IND submission.

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false General principles of the IND submission. 312.22... (IND) § 312.22 General principles of the IND submission. (a) FDA's primary objectives in reviewing an... likelihood that the investigations will yield data capable of meeting statutory standards for marketing...

  3. Drugs@FDA Database

    U.S. Department of Health & Human Services — Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of...

  4. FDA Acronyms and Abbreviations

    U.S. Department of Health & Human Services — The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities

  5. Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?

    Berglund, Jelena P.; Weatherwax, Kevin; Gerber, David E.; Adamo, Joan E.

    2015-01-01

    Abstract Purpose The Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. PMID:25588691

  6. Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

    Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E

    2015-10-01

    The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.

  7. FDA Recognized Consensus Standards

    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...

  8. FDA Drug Label Data

    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...

  9. IND - THE IND DECISION TREE PACKAGE

    Buntine, W.

    1994-01-01

    A common approach to supervised classification and prediction in artificial intelligence and statistical pattern recognition is the use of decision trees. A tree is "grown" from data using a recursive partitioning algorithm to create a tree which has good prediction of classes on new data. Standard algorithms are CART (by Breiman Friedman, Olshen and Stone) and ID3 and its successor C4 (by Quinlan). As well as reimplementing parts of these algorithms and offering experimental control suites, IND also introduces Bayesian and MML methods and more sophisticated search in growing trees. These produce more accurate class probability estimates that are important in applications like diagnosis. IND is applicable to most data sets consisting of independent instances, each described by a fixed length vector of attribute values. An attribute value may be a number, one of a set of attribute specific symbols, or it may be omitted. One of the attributes is delegated the "target" and IND grows trees to predict the target. Prediction can then be done on new data or the decision tree printed out for inspection. IND provides a range of features and styles with convenience for the casual user as well as fine-tuning for the advanced user or those interested in research. IND can be operated in a CART-like mode (but without regression trees, surrogate splits or multivariate splits), and in a mode like the early version of C4. Advanced features allow more extensive search, interactive control and display of tree growing, and Bayesian and MML algorithms for tree pruning and smoothing. These often produce more accurate class probability estimates at the leaves. IND also comes with a comprehensive experimental control suite. IND consists of four basic kinds of routines: data manipulation routines, tree generation routines, tree testing routines, and tree display routines. The data manipulation routines are used to partition a single large data set into smaller training and test sets. The

  10. EVA geen FDA

    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

  11. IND/NDA process

    Frankel, R.; Kawin, B.

    1981-01-01

    This summary provides a brief, general discussion of new drug applications, the reasons for their submission to FDA, and general features of their evaluation by FDA. The generic statutory and regulatory foundation that underlies the purposes and implements the development and testing of new drugs is briefly outlined

  12. FDA Warns About Stem Cell Therapies

    ... Home For Consumers Consumer Updates FDA Warns About Stem Cell Therapies Share Tweet Linkedin Pin it More sharing ... see the boxed section below for more advice. Stem Cell Uses and FDA Regulation The FDA has the ...

  13. 21 CFR 312.120 - Foreign clinical studies not conducted under an IND.

    2010-04-01

    ... accept as support for an IND or application for marketing approval (an application under section 505 of... independent ethics committee (IEC) before initiating a study, continuing review of an ongoing study by an IEC... marketing approval a study that does not meet the conditions of paragraph (a)(1) of this section, FDA will...

  14. FDA regulation of tobacco: blessing or curse for FDA professionals?

    O'Reilly, James T

    2009-01-01

    Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.

  15. Harvard Catalyst | The Clinical Translational Science Center IND/IDE Consult Service: Providing an IND/IDE Consult Service in a Decentralized Network of Academic Healthcare Centers

    Winkler, Sabune J.; Bierer, Barbara E.; Wolf, Delia

    2014-01-01

    Abstract The Food and Drug Administration (FDA) regulations require sponsors of clinical investigations involving an investigational drug or device to submit an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. Strict adherence to applicable regulations is vital to the success of clinical research. Unlike most major pharmaceutical sponsors, investigator sponsors often do not fully appreciate their regulatory obligations nor have resources to ensure compliance. As a result they can place themselves and their institutions at risk. Nevertheless, investigator‐initiated clinical trials are vital to the further development of innovative drugs, biologics, and medical devices. The IND/IDE Subcommittee under the Regulatory Knowledge and Support Program at Harvard Catalyst, The Harvard Clinical and Translational Science Center worked in collaboration with Harvard and Harvard affiliated institutions to create and launch an IND/IDE Consult Service in a decentralized network of collaborating Academic Healthcare Centers (AHC). The IND/IDE Consult Service offers expertise, resources, and shared experiences to assist sponsor‐investigators and IRBs in meeting regulatory requirements for conducting and reviewing investigator‐initiated IND/IDE studies. The scope of the services provided by the Harvard Catalyst IND/IDE Consult Service are described, including the specifics of the service, lessons learned, and challenges faced, in a scalable model that builds inter‐institutional capacity. PMID:24455986

  16. Harvard Catalyst | The Clinical Translational Science Center IND/IDE Consult Service: providing an IND/IDE consult service in a decentralized network of academic healthcare centers.

    Kim, Min J; Winkler, Sabune J; Bierer, Barbara E; Wolf, Delia

    2014-04-01

    The Food and Drug Administration (FDA) regulations require sponsors of clinical investigations involving an investigational drug or device to submit an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. Strict adherence to applicable regulations is vital to the success of clinical research. Unlike most major pharmaceutical sponsors, investigator sponsors often do not fully appreciate their regulatory obligations nor have resources to ensure compliance. As a result they can place themselves and their institutions at risk. Nevertheless, investigator-initiated clinical trials are vital to the further development of innovative drugs, biologics, and medical devices. The IND/IDE Subcommittee under the Regulatory Knowledge and Support Program at Harvard Catalyst, The Harvard Clinical and Translational Science Center worked in collaboration with Harvard and Harvard affiliated institutions to create and launch an IND/IDE Consult Service in a decentralized network of collaborating Academic Healthcare Centers (AHC). The IND/IDE Consult Service offers expertise, resources, and shared experiences to assist sponsor-investigators and IRBs in meeting regulatory requirements for conducting and reviewing investigator-initiated IND/IDE studies. The scope of the services provided by the Harvard Catalyst IND/IDE Consult Service are described, including the specifics of the service, lessons learned, and challenges faced, in a scalable model that builds inter-institutional capacity. © 2014 Wiley Periodicals, Inc.

  17. FDA Peanut-Containing Product Recall

    U.S. Department of Health & Human Services — The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products...

  18. 78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    2013-03-05

    ... FDA's Product Tracing Web page at http://www.fda.gov/Food/FoodSafety/FSMA/ucm270851.htm . This... Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Request for Comments and... Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food...

  19. FDA Approves First Therapeutic Cancer Vaccine

    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.

  20. Gottlieb, the FDA and dumbing down medicine

    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...

  1. FDA and the Chemical Brain Drainers

    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...

  2. Virtual Exploratories

    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...

  3. Le cas de l'Inde

    pwust

    approche de l'Inde en matière de collaboration internationale. Enfin, la cinquième .... L'Inde n'adhère pas non plus à une définition uniforme de l'aide au développement. Ce que ..... commerce (OMC) et défendu l'inviolabilité du droit international.

  4. En ny flugt ind i skoven

    Haarder, Jon Helt

    2008-01-01

    Thure Erik Lund: IND. (Inn). Oversat fra norsk af Sara Koch. 192 sider, 199 kr. Gyldendal. UDKOMMER I DAG. Fire stjerner......Thure Erik Lund: IND. (Inn). Oversat fra norsk af Sara Koch. 192 sider, 199 kr. Gyldendal. UDKOMMER I DAG. Fire stjerner...

  5. Indflydelse. Hvide evangelister er inde i varmen

    Olsen, Gorm Rye

    2016-01-01

    ANALYSE De hvide evangelister bar Trump ind i Det Hvide Hus. Det vil få stor betydning for USA's udenrigspolitik.......ANALYSE De hvide evangelister bar Trump ind i Det Hvide Hus. Det vil få stor betydning for USA's udenrigspolitik....

  6. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

  7. FDA regulations for commercial food irradiation

    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

  8. Regulating nanomedicine - can the FDA handle it?

    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

  9. Evaluating eating behavior treatments by FDA standards

    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.

  10. Mining FDA drug labels for medical conditions.

    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.

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

    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...

  12. 21 CFR 60.10 - FDA assistance on eligibility.

    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...

  13. Gottlieb, the FDA and dumbing down medicine

    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 …

  14. 21 CFR 60.34 - FDA action on petitions.

    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...

  15. FDA approves efavirenz. Food and Drug Administration.

    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.

  16. Fisher, Neyman, and Bayes at FDA.

    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.

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

    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.

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

    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 ...

  19. Lengua indígena: lengua extranjera en tierra indígena

    Wilmar da Rocha D'Angelis

    2009-07-01

    Full Text Available A pesar de las reiteradas manifestaciones y instrucciones al respecto del valor de las lenguas indígenas y sobre la importancia de la enseñanza en lengua materna, sea en documentos oficiales del gobierno brasileño, sea en artículos, declaraciones y propuestas firmadas por maestros indígenas o por pesquisadores no indígenas, el hecho es que en la mayor parte de los programas educacionales en comunidades indígenas de Brasil el espacio destinado a la lengua autóctona es muy semejante a lo que acostumbramos encontrar para una lengua extranjera en la escuela nacional. Como a menudo los maestros indígenas demuestran tener convicción en la necesidad de valorizar y fortalecer sus lenguas propias, y son - ellos mismos - hablantes nativos de sus lenguas, las preguntas que se plantean son: ¿Por cuales razones las escuelas indígenas siguen restringiendo el espacio de la lengua autóctona? ¿Es posible que los maestros indígenas de hecho estén creyentes de las potencialidades y en el futuro de su lengua materna? Y, por fin, ¿Serán las presiones de la burocracia o de maestros no-indígenas en la escuela indígena lo que impide la experimentación de programas auténticamente bilingües?.Despite the repeated demonstrations and instructions about the value of indigenous languages and the importance of education in mother tongue, whether in official documents of the Brazilian government, whether in articles, statements and proposals signed by indigenous teachers or non-indigenous researchers, the fact is that in the most educational programs in indigenous communities in Brazil the space for the native language is very similar to that usually found for a foreign language in the national school. As indigenous teachers often prove to have belief in the need to value and strengthen their own languages, and are - themselves - native speakers of that, the questions that arise are: Why reasons indigenous schools continue to restrict the space of the

  20. Indústria cultural e meio rural

    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

  1. Regulatory considerations concerning IND radiopharmaceutical drug products

    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

  2. 21 CFR 312.86 - Focused FDA regulatory research.

    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...

  3. 42 CFR 405.203 - FDA categorization of investigational devices.

    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...

  4. Changes In Growth Culture FDA Activity Under Changing Growth Conditions

    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....

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

    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.

  6. 76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

    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...

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

    ... 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 ...

  8. Subarray-based FDA radar to counteract deceptive ECM signals

    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.

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

    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 ...

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

    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.

  11. Indústria do conhecimento: uma poderosa engrenagem

    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...

  12. Derechos Humanos en Poblaciones Indígenas

    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

  13. En rejse ind i dental biofilm

    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...

  14. FDA Developments: Food Code 2013 and Proposed Trans Fat Determination

    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

  15. FDA-approved small-molecule kinase inhibitors

    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...

  16. 21 CFR 5.1110 - FDA public information offices.

    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...

  17. FDA's requirements for radiation dosimetry of radiopharmaceutical drug products

    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

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

    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.

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

    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

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

    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.

  1. FDA actions against health economic promotions, 2002-2011.

    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.

  2. Three Drugs Approved for Urothelial Carcinoma by FDA.

    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.

  3. Current and future state of FDA-CMS parallel reviews.

    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.

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

    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.

  5. Jeroky Mbaekua - aspectos da etnoarte indígena.

    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.

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

    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

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

    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

  8. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    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...

  9. Managing exploratory innovation

    Charue-Duboc , Florence; Aggeri , Franck; Chanal , Valérie; Garel , Gilles

    2010-01-01

    Although the concept of exploration has been widely used in management research since James March's seminal article, the literature on exploration remains rather fuzzy. The question of exploration is dominated by the literature on ambidexterity but this research actually says little about concretely managing exploratory innovation itself, although this appears to be a central concern of most industrial firms today. Based on a material (twenty presentations made in a research seminar the autho...

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

    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 ...

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

    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.

  12. Inde | Page 43 | CRDI - Centre de recherches pour le ...

    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 ...

  13. Integration of new technology into clinical practice after FDA approval.

    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.

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

    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.

  15. Automatic extraction of drug indications from FDA drug labels.

    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.

  16. Exploratory of society

    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.

  17. Stem-cell-derived products: an FDA update.

    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. 2016 in review: FDA approvals of new molecular entities.

    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.

  19. FDA toxicity databases and real-time data entry

    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

  20. Testamentos de indígenas americanos: siglos XVI - XVII

    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.

  1. Educación indígena

    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.

  2. Buen vivir y pueblos indígenas en Colombia

    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...

  3. Juventud indígena en el Totonacapan Veracruzano

    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.

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

    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 ...

  5. de las mujeres indígenas migrantes

    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.

  6. Exploratory orbit analysis

    Michelotti, L.

    1989-03-01

    Unlike the other documents in these proceedings, this paper is neither a scientific nor a technical report. It is, rather, a short personal essay which attempts to describe an Exploratory Orbit Analysis (EOA) environment. Analyzing the behavior of a four or six dimensional nonlinear dynamical system is at least as difficult as analyzing events in high-energy collisions; the consequences of doing it badly, or slowly, would be at least as devastating; and yet the level of effort and expenditure invested in the latter, the very attention paid to it by physicists at large, must be two orders of magnitude greater than that given to the former. It is difficult to choose the model which best explains the behavior of a physical device if one does not first understand the behavior of the available models. The time is ripe for the development of a functioning EOA environment, which I will try to describe in this paper to help us achieve this goal

  7. Exploratory orbit analysis

    Michelotti, L.

    1989-03-01

    Unlike the other documents in these proceedings, this paper is neither a scientific nor a technical report. It is, rather, a short personal essay which attempts to describe an Exploratory Orbit Analysis (EOA) environment. Analyzing the behavior of a four or six dimensional nonlinear dynamical system is at least as difficult as analyzing events in high-energy collisions; the consequences of doing it badly, or slowly, would be at least as devastating; and yet the level of effort and expenditure invested in the latter, the very attention paid to it by physicists at large, must be two orders of magnitude greater than that given to the former. It is difficult to choose the model which best explains the behavior of a physical device if one does not first understand the behavior of the available models. The time is ripe for the development of a functioning EOA environment, which I will try to describe in this paper to help us achieve this goal.

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

    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.

  9. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    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...

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

    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.

  11. FDA-Approved Natural Polymers for Fast Dissolving Tablets

    Md Tausif Alam

    2014-01-01

    Full Text Available Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing, in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets.

  12. The US FDA and animal cloning: risk and regulatory approach.

    Rudenko, Larisa; Matheson, John C

    2007-01-01

    The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used.

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

    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...

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

    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

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

    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.

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

    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

  17. Editorial: Anastasia Candre y otros creadores indígenas

    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.

  18. Zoom on India | Gros plan sur l’Inde

    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...

  19. Exploratory studies, 1991

    1992-03-01

    The Exploratory Studies Group is dedicated to advanced investigation of accelerators and radiation, primarily in the area of charged-particle beams and photon beams. Its primary mission is to explore the next steps in the development of particle accelerators and storage rings, which are important both for high-energy physics and for the wide range of disciplines now turning to synchrotron-radiation sources and free-electron lasers. Our research is therefore deeply committed to LBL's institutional goal of becoming a center for the generation and use of coherent and incoherent electromagnetic radiation of exceptional brightness, as well as for generic research on the future development of accelerators. A significant fraction of our effort is dedicated to general accelerator-physics research for facilities on the immediate horizon, but a vital part of our activities comprises research into exotic possibilities for charged-particle production, accumulation, acceleration, and storage. During this report period, we were proncipally involved in four general areas of study: Accelerator-physics research for the Advanced Light Source, the 1-2 GeV synchrotron radiation source now under construction at LBL. In collaboration with the Stanford Linear Accelerator Center, both the conceptual and the detailed design of PEP-II, an energy-asymmetric electron-positron collider, based on the PEP ring at SLAC and designed to serve as a B-meson factory. Studies of ultraviolet and infrared free-electron lasers based on linear accelerators and storage rings, in particular the conceptual design of an infrared free-electron laser for the proposed Chemical Dynamics Research Laboratory at LBL. Generic high-energy accelerator-physics and photon-beam research directed far into the future to envision facilities that would employ new techniques of particle-beam acceleration and storage and photon-beam generation

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

    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.

  1. Cultura indígina e identidade nacional

    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.

  2. IndElec: A Software for Analyzing Party Systems and Electoral Systems

    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.

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

    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.

  4. Representantes y representaciones indígenas en el altiplano occidental de Guatemala

    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...

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

    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.

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

    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.

  7. MedWatch, the FDA Safety Information and Adverse Event Reporting Program

    ... 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 ...

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

    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.

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

    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.

  10. Trenching as an exploratory method

    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

  11. An economic and financial exploratory

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

    2012-01-01

    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

  12. Exploratory Analysis in Learning Analytics

    Gibson, David; de Freitas, Sara

    2016-01-01

    This article summarizes the methods, observations, challenges and implications for exploratory analysis drawn from two learning analytics research projects. The cases include an analysis of a games-based virtual performance assessment and an analysis of data from 52,000 students over a 5-year period at a large Australian university. The complex…

  13. El misionero ante las culturas Indígenas

    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.

  14. Between Two Empires. Histoire des deux Indes And Modern Colonialism

    Alessandro Pandolfi

    2013-07-01

    Full Text Available The article critically analyses the late eighteenth century process of crisis and transformation of the concept of empire. By considering Raynal’s Histoire des deux Indes and the Enlightenment’s critique of the different imperial models, Pandolfi reconstructs the transit from classic colonialism – built around the relations between settlers, savages and slaves – to another phase characterized by the indirect exploitation of the labour force. The text underlines the ambivalence of Enlightenment towards the question of the empire by demonstrating how Raynal’s work reflects the constitutive tension of the second half of the 1700s. Therefore, through Diderot’s analysis, the author demonstrates how the moral advancement of humanity is the product of a constant interaction between the colonial rhetoric of commerce and those revolutions, which, – in different moments and places – have crossed the colonial space.

  15. Estado nacional y nacionalidades indígenas.

    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.

  16. Indústrias criativas: definição, limites e possibilidades

    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...

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

    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.

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

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

    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.

  20. An economic and financial exploratory

    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.

  1. An economic and financial exploratory

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

    2012-01-01

    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...

  2. Trenching as a exploratory method

    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

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

    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.

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

    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.

  5. Turismo, patrimonio y comunidades indígenas

    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

  6. La diffusion spatiale de l’informatique en Inde

    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.

  7. Le pétrole en Inde Oil in India

    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.

  8. Ecología y Salud Indígena

    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

  9. La educación indígena en el Estado de México

    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 ...

  10. La educación indígena en el Estado de México

    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...

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

    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.

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

    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.

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

    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.

  14. Pluralismo jurídico: derecho indígena y justicia nacional

    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.

  15. Utilização de controles de gestão nas maiores indústrias catarinenses

    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

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

    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.

  17. Indígenas Antropólogos e o Espetáculo da Alteridade

    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

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

    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...

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

    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.

  20. FDA publishes checklist of Y2K high-risk devices.

    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.

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

    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.

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

    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.

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

    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,…

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

    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

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

    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.

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

    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

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

    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

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

    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.

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

    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.

  10. 75 FR 28622 - FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of...

    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...

  11. Nanotechnology Laboratory Continues Partnership with FDA and National Institute of Standards and Technology | Poster

    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

  12. 21 CFR 111.610 - What records must be made available to FDA?

    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...

  13. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    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...

  14. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    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...

  15. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    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...

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

    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.

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

    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

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

    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

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

    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.

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

    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.

  1. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    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...

  2. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    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...

  3. 21 CFR 14.15 - Committees working under a contract with FDA.

    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...

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

    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

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

    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

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

    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

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

    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.

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

    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.

  9. Update of the exploratory report Acrolein

    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.

  10. Entrepreneurs’ Exploratory Perseverance in Learning Settings

    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

  11. 76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

    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...

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

    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

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

    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

  14. Saúde reprodutiva e mulheres indígenas do Alto Rio Negro

    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.

  15. Exploratory shaft liner corrosion estimate

    Duncan, D.R.

    1985-10-01

    An estimate of expected corrosion degradation during the 100-year design life of the Exploratory Shaft (ES) is presented. The basis for the estimate is a brief literature survey of corrosion data, in addition to data taken by the Basalt Waste Isolation Project. The scope of the study is expected corrosion environment of the ES, the corrosion modes of general corrosion, pitting and crevice corrosion, dissimilar metal corrosion, and environmentally assisted cracking. The expected internal and external environment of the shaft liner is described in detail and estimated effects of each corrosion mode are given. The maximum amount of general corrosion degradation was estimated to be 70 mils at the exterior and 48 mils at the interior, at the shaft bottom. Corrosion at welds or mechanical joints could be significant, dependent on design. After a final determination of corrosion allowance has been established by the project it will be added to the design criteria. 10 refs., 6 figs., 5 tabs

  16. Estratégias para Criação da Indústria Aeroespacial Brasileira

    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-...

  17. A presença feminina nas indústrias de lingerie na cidade de Franca

    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...

  18. A formação do professor indígena

    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.

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

    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.

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

    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...

  1. Notas sobre a indústria do entretenimento musical e identidade no Brasil

    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

  2. Los mayas del altiplano: supervivencia indígena en Chiapas y Guatemala

    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...

  3. A Indústria de Defesa, Inovação e Competitividade

    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...

  4. Corporeidade indígena sob o ângulo da praxeologia

    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...

  5. Migraciones indígenas a las ciudades de México y Tijuana

    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...

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

    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 ...

  7. La multiculturalidad de la Ciudad de México y los Derechos Indígenas

    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 ...

  8. Derechos humanos de los pueblos indígenas: Panorama colombiano

    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...

  9. Benchmarking e a indústria do conhecimento: um estudo de caso

    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...

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

    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...

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

    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...

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

    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.

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

    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.

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

    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.

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

    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.

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

    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.

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

    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

  18. The FDA Food Safety and Modernization Act and the Exemption for Small Firms

    Pouliot, Sebastien

    2011-01-01

    The FDA Food Safety Modernization Act of 2010 is new legislation that mandates, among other things, new food safety standards. The act includes a clause that exempts small firms from new regulatory requirements. This paper investigates the effects of a small firm exemption from more stringent food safety standards. The model compares food safety, total output and the number of market participants for different food safety regulation with and without an exemption for small firms. The numerical...

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

    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

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

    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

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

    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.

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

    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

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

    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.

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

    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.

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

    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.

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

    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.

  7. Sociometric Indicators of Leadership: An Exploratory Analysis

    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

  8. Exploratory boreholes Juchlistock-Grimsel

    Mueller, W.; Keusen, H.R.

    1981-11-01

    The aim of the investigation was the completion of missing geological, hydrogeological and rock-mechanical data about a suitable site for the intended Nagra rock laboratory at Grimsel. To this aim, 6 horizontal boreholes of 100 m length and 86 mm diameter were drilled. The cores, extracted practically without loss, and mechanical data for the main investigation was an extensive evaluation of the lithographic discontinuities and anisotropies, because they are the main determinant of the hydrogeological conditions of the locality. The area is dominated by granites and granodiorite which are of variable biotite content, lamprophyres and aplites. The largest part of the investigated mountain region consists of compact unclefted rock. 478 of the 600 bore meters, i.e. about 80 % of the drilled mountain, have no open clefts. Only 22 of the 600 bore meters (3.6 %0 contain more than five clefts per meter, at which the open clefts in the boreholes SB1 and SB5 appear more frequently. At the remaining exploratory boreholes in 90 % of the mountain ther are no open clefts. 15 refs., 52 figs., 15 tabs

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

    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.

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

    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

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

    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.

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

    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 ...

  13. El título indígena y su aplicabilidad en el Derecho chileno

    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.

  14. A General Construction of IND-CCA2 Secure Public Key Encryption

    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....

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

    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 ...

  16. Los dererchos humanos de las etnias indígenas en colombia

    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

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

    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.

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

    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.

  19. A presença feminina nas indústrias de lingerie na cidade de Franca

    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.

  20. Etnoeducación Indígena Intercultural en el Caribe Colombiano

    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.

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

    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...

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

    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.

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

    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.

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

    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...

  5. Las organizaciones indígenas peruanas, pioneras de la educación intercultural bilingüe

    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.

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

    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.

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

    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

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

    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

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

    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

  10. Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models.

    Uebbing, Lukas; Klumpp, Lukas; Webster, Gregory K; Löbenberg, Raimar

    2017-01-01

    Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA) has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR) formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP) were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning) impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is DPP controlled, disintegration, intrinsic dissolution and dissolution testing were performed in conventional and disintegration impacting media (DIM). Tablet disintegration was affected by DIM and model fitting to the Korsmeyer-Peppas equation showed a growing effect of the formulation in DIM. DDDPlus was able to predict tablet dissolution and the intrinsic dissolution profiles in conventional media and DIM. The study showed that disintegration has to occur before DPP-dependent dissolution can happen. The study suggests that

  11. Association of Attorney Advertising and FDA Action with Prescription Claims: A Time Series Segmented Regression Analysis.

    Tippett, Elizabeth C; Chen, Brian K

    2015-12-01

    Attorneys sponsor television advertisements that include repeated warnings about adverse drug events to solicit consumers for lawsuits against drug manufacturers. The relationship between such advertising, safety actions by the US Food and Drug Administration (FDA), and healthcare use is unknown. To investigate the relationship between attorney advertising, FDA actions, and prescription drug claims. The study examined total users per month and prescription rates for seven drugs with substantial attorney advertising volume and FDA or other safety interventions during 2009. Segmented regression analysis was used to detect pre-intervention trends, post-intervention level changes, and changes in post-intervention trends relative to the pre-intervention trends in the use of these seven drugs, using advertising volume, media hits, and the number of Medicare enrollees as covariates. Data for these variables were obtained from the Center for Medicare and Medicaid Services, Kantar Media, and LexisNexis. Several types of safety actions were associated with reductions in drug users and/or prescription rates, particularly for fentanyl, varenicline, and paroxetine. In most cases, attorney advertising volume rose in conjunction with major safety actions. Attorney advertising volume was positively correlated with prescription rates in five of seven drugs, likely because advertising volume began rising before safety actions, when prescription rates were still increasing. On the other hand, attorney advertising had mixed associations with the number of users per month. Regulatory and safety actions likely reduced the number of users and/or prescription rates for some drugs. Attorneys may have strategically chosen to begin advertising adverse drug events prior to major safety actions, but we found little evidence that attorney advertising reduced drug use. Further research is needed to better understand how consumers and physicians respond to attorney advertising.

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

    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...

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

    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...

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

    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...

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

    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...

  16. FDA advisory committees meet January 26 on Salk HIV-1 immunogen.

    1995-01-06

    Two advisory committees of the Food and Drug Administration (FDA) will meet to consider future trials of the HIV-1 immunogen developed by Dr. Jonas Salk. The Immune Response Corporation has already conducted several studies of the immunogen, and has found improvement in various immunological and other blood tests, and no adverse effects. However, the studies have not been large enough to show conclusively that the treatment has clinical benefit in delaying disease progression. The new, larger trials are intended to demonstrate a delay in disease progression and validate the use of blood-test markers of disease progression for studying an immune-based treatment.

  17. FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster

    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.

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

    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

  19. 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?

    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.

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

    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.

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

    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.

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

    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.

  3. Drugs Cleared Through The FDA's Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process.

    Chambers, James D; Thorat, Teja; Wilkinson, Colby L; Neumann, Peter J

    2017-08-01

    We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999-2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes. We found that drugs in at least one expedited review program offered greater gains than drugs reviewed through conventional processes (0.182 versus 0.003 QALYs). We also found that, compared to drugs not included in the same program, greater gains were provided by drugs in the priority review (0.175 versus 0.007 QALYs), accelerated approval (0.370 versus 0.031 QALYs), and fast track (0.254 versus 0.014 QALYs) programs. Our analysis suggests that the FDA has prioritized drugs that offer the largest health gains. Project HOPE—The People-to-People Health Foundation, Inc.

  4. FDA cigarette warning labels lower craving and elicit frontoinsular activation in adolescent smokers

    Do, Kathy T.

    2015-01-01

    Cigarette smoking is an economically and epidemiologically expensive public health concern. Most adult smokers become addicted during adolescence, rendering it a crucial period for prevention and intervention. Although litigation claims have delayed implementation, graphic warning labels proposed by the U.S. Food and Drug Administration (FDA) may be a promising way to achieve this goal. We aimed to determine the efficacy of the labels in reducing in-scanner craving and to characterize the neurobiological responses in adolescent and adult smokers and non-smokers. While undergoing functional magnetic resonance imaging, thirty-nine 13- to 18-year-old adolescent and forty-one 25- to 30-year-old adult smokers and non-smokers rated their desire to smoke when presented with emotionally graphic warning labels and comparison non-graphic labels. Compared with adult smokers, adolescent smokers exhibited greater craving reduction in response to the warning labels. Although smokers evinced overall blunted recruitment of insula and dorsolateral prefrontal cortex (DLPFC) relative to non-smokers, an effect that was stronger in adolescent smokers, parametrically increasing activation of these regions was associated with greater craving reduction. Functional connectivity analyses suggest that greater DLPFC regulation of limbic regions predicted cigarette craving. These data underscore a prominent role of frontoinsular circuitry in predicting the efficacy of FDA graphic warning labels in craving reduction in adult and adolescent smokers. PMID:25887154

  5. Smokers' reactions to FDA regulation of tobacco products: Findings from the 2009 ITC United States survey

    Fix Brian V

    2011-12-01

    Full Text Available Abstract Background On June 22, 2009, the US FDA was granted the authority to regulate tobacco products through the Family Smoking Prevention and Tobacco Control Act (FSPTCA. The intent is to improve public health through regulations on tobacco product marketing and tobacco products themselves. This manuscript reports baseline data on smokers' attitudes and beliefs on specific issues relevant to the FSPTCA. Method Between November 2009 and January 2010, a telephone survey among a nationally representative sample of n = 678 smokers in the US was performed as part of the International Tobacco Control (ITC United States Survey. Participants answered a battery of questions on their attitudes and beliefs about aspects of the FSPTCA. Results Most smokers were unaware of the new FDA tobacco regulations. Smokers indicated support for banning cigarette promotion and nearly a quarter supported requiring tobacco companies to sell cigarettes in plain packaging. Seventy two percent of smokers supported reducing nicotine levels to make cigarettes less addictive if nicotine was made easily available in non-cigarette form. Conclusion Most smokers were limited in their understanding of efforts to regulate tobacco products in general. Smokers were supportive of efforts to better inform the public about health risks, restrict advertising, and make tobacco products less addictive.

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

    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.

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

    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.

  8. Randomized, double-blind, placebo-controlled study of zeaxanthin and visual function in patients with atrophic age-related macular degeneration: the Zeaxanthin and Visual Function Study (ZVF) FDA IND #78, 973.

    Richer, Stuart P; Stiles, William; Graham-Hoffman, Kelly; Levin, Marc; Ruskin, Dennis; Wrobel, James; Park, Dong-Wouk; Thomas, Carla

    2011-11-01

    The purpose of this study is to evaluate whether dietary supplementation with the carotenoid zeaxanthin (Zx) raises macula pigment optical density (MPOD) and has unique visual benefits for patients with early atrophic macular degeneration having visual symptoms but lower-risk National Institute of Health/National Eye Institute/Age-Related Eye Disease Study characteristics. This was a 1-year, n = 60 (57 men, 3 women), 4-visit, intention-to-treat, prospective, randomized controlled clinical trial of patients (74.9 years, standard deviation [SD] 10) with mild-to-moderate age-related macular degeneration (AMD) randomly assigned to 1 of 2 dietary supplement carotenoid pigment intervention groups: 8 mg Zx (n = 25) and 8 mg Zx plus 9 mg lutein (L) (n = 25) or 9 mg L ("Faux Placebo," control group, n = 10). Analysis was by Bartlett's test for equal variance, 3-way repeated factors analysis of variance, independent t test (P < 0.05) for variance and between/within group differences, and post-hoc Scheffé's tests. Estimated foveal heterochromic flicker photometry, 1° macular pigment optical density (MPOD QuantifEye(®)), low- and high-contrast visual acuity, foveal shape discrimination (Retina Foundation of the Southwest), 10° yellow kinetic visual fields (KVF), glare recovery, contrast sensitivity function (CSF), and 6° blue cone ChromaTest(®) color thresholds were obtained serially at 4, 8, and 12 months. Ninety percent of subjects completed ≥ 2 visits with an initial Age-Related Eye Disease Study report #18 retinopathy score of 1.4 (1.0 SD)/4.0 and pill intake compliance of 96% with no adverse effects. There were no intergroup differences in 3 major AMD risk factors: age, smoking, and body mass index as well as disease duration and Visual Function Questionnaire 25 composite score differences. Randomization resulted in equal MPOD variance and MPOD increasing in each of the 3 groups from 0.33 density units (du) (0.17 SD) baseline to 0.51 du (0.18 SD) at 12 m, (P = 0.03), but no between-group differences (Analysis of Variance; P = 0.47). In the Zx group, detailed high-contrast visual acuity improved by 1.5 lines, Retina Foundation of the Southwest shape discrimination sharpened from 0.97 to 0.57 (P = 0.06, 1-tail), and a larger percentage of Zx patients experienced clearing of their KVF central scotomas (P = 0.057). The "Faux Placebo" L group was superior in terms of low-contrast visual acuity, CSF, and glare recovery, whereas Zx showed a trend toward significance. In older male patients with AMD, Zx-induced foveal MPOD elevation mirrored that of L and provided complementary distinct visual benefits by improving foveal cone-based visual parameters, whereas L enhanced those parameters associated with gross detailed rod-based vision, with considerable overlap between the 2 carotenoids. The equally dosed (atypical dietary ratio) Zx plus L group fared worse in terms of raising MPOD, presumably because of duodenal, hepatic-lipoprotein or retinal carotenoid competition. These results make biological sense based on retinal distribution and Zx foveal predominance. Published by Elsevier Inc.

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

    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.

  10. Exploratory Research and Development Fund, FY 1990

    1992-05-01

    The Lawrence Berkeley Laboratory Exploratory R ampersand D Fund FY 1990 report is compiled from annual reports submitted by principal investigators following the close of the fiscal year. This report describes the projects supported and summarizes their accomplishments. It constitutes a part of an Exploratory R ampersand D Fund (ERF) planning and documentation process that includes an annual planning cycle, projection selection, implementation, and review. The research areas covered in this report are: Accelerator and fusion research; applied science; cell and molecular biology; chemical biodynamics; chemical sciences; earth sciences; engineering; information and computing sciences; materials sciences; nuclear science; physics and research medicine and radiation biophysics

  11. Exploratory Research and Development Fund, FY 1990

    1992-05-01

    The Lawrence Berkeley Laboratory Exploratory R D Fund FY 1990 report is compiled from annual reports submitted by principal investigators following the close of the fiscal year. This report describes the projects supported and summarizes their accomplishments. It constitutes a part of an Exploratory R D Fund (ERF) planning and documentation process that includes an annual planning cycle, projection selection, implementation, and review. The research areas covered in this report are: Accelerator and fusion research; applied science; cell and molecular biology; chemical biodynamics; chemical sciences; earth sciences; engineering; information and computing sciences; materials sciences; nuclear science; physics and research medicine and radiation biophysics.

  12. Exploratory multivariate analysis by example using R

    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

  13. Revueltas indígenas en el Perú tardocolonial

    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...

  14. Criatividade e inovação empresarial nas indústrias criativas

    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 ...

  15. El anciano en las comunidades indígenas Páez y Zenú

    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.

     

  16. Prevalencia de diabetes mellitus e hiperlipidemias en indígenas otomíes

    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...

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

    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.

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

    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.

  19. Çocuk Diş Hekimliğinde Oral ve İntranazal Yollarla Orta Dereceli Sedasyon

    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

  20. Web 2.0 trænger ind i skolen

    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...

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

    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 ...

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

    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 ...

  3. Créer des emplois pour combler l'absence de milieu en Inde | CRDI ...

    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 ...

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

    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.

  5. Skill Transfer and Virtual Training for IND Response Decision-Making: Project Summary and Next Steps

    2016-04-12

    Lincoln Laboratory MASSACHUSETTS INSTITUTE OF TECHNOLOGY LEXINGTON, MASSACHUSETTS Technical Report 1209 Skill Transfer and Virtual ...specifically authorized by the U.S. Government may violate any copyrights that exist in this work. Skill Transfer and Virtual Training for IND Response...lns:ull of lmme<lla:e 0 evacua!lon). but many aspects are the same (such as !’laVIng fresh water . knowing evacua:Jon routn. and tlavtng a

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

    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.

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

    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 ...

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

    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 ...

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

    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 ...

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

    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

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

    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.

  12. Artes indígenas, patrimônio cultural e mercado

    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.

  13. Infraestructura y calidad educativa entre los pueblos indígenas originarios sonorenses

    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.

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

    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)

  15. Percepciones de comportamientos parentales de jóvenes indígenas mexicanos

    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.

  16. La multiculturalidad de la ciudad de México y los derechos indígenas

    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.

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

    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.

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

    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.

  19. Tendencias de Educación Indígena en Latinoamérica.

    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.

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

    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.

  1. Implicações do uso do álcool na comunidade indígena Potiguara Implications of alcohol abuse and consumption in the Potiguara indigenous community

    Juliana Rízia Félix de Melo

    2011-01-01

    Full Text Available Em função do crescimento do uso e do abuso do álcool nas populações indígenas do Brasil, esta pesquisa se propôs a investigar o consumo do álcool na comunidade Potiguara do Estado da Paraíba, devido à especificidade cultural e regional desta etnia. Trata-se de um estudo de campo exploratório. A amostra foi composta por 55 índios, maiores de 18 anos e de ambos os sexos. O instrumento utilizado foi uma entrevista semiestruturada aplicada individualmente. Para a análise dos dados, foi utilizado o software SPSS e Análise de Conteúdo Temática. Os resultados revelaram que 41,8% da amostra estudada têm, pelo menos, um membro da família que faz uso de bebida alcoólica, em sua maioria destiladas, e que o uso ocorre em idade precoce, estando desvinculado da cultura e de rituais. Dos entrevistados 27,3% afirmaram que a bebida traz diversos problemas para toda a família, inclusive com a morte. Pode-se concluir que, na população indígena estudada, o consumo de bebidas alcoólicas já ocorre de forma abusiva e precoce, necessitando-se de um trabalho mais efetivo de prevenção e de resgate da cultura desta comunidade.Due to the growth of usage and alcohol abuse in indigenous populations of Brazil, this research aims to investigate alcohol consumption in the Potiguara community, in the State of Paraíba, considering its specific cultural and regional differences of ethnicity. This is an exploratory field study. The sample consisted of 55 Indians, aged over 18 years and of both sexes. The instrument was a semistructured interview administered individually. For data analysis, we used the SPSS software and qualitative analysis. The results revealed that 41.8% of the sample have at least one family member who uses alcohol, mostly distilled, and that use starts at an early age, being detached from the culture and rituals. Of the respondents 27.3% said that drinking brings many problems for the entire family, including death. We can concluded

  2. 18 CFR 430.11 - Advance notice of exploratory drilling.

    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...

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

    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

  4. Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models

    Uebbing L

    2017-04-01

    Full Text Available Lukas Uebbing,1,2,* Lukas Klumpp,1,3,* Gregory K Webster,4 Raimar Löbenberg1 1Faculty of Pharmacy and Pharmaceutical Sciences, Katz Group-Rexall Centre for Pharmacy and Health Research, University of Alberta, Edmonton, Canada; 2Institute of Pharmacy and Biochemistry, Johannes Gutenberg University, Mainz, 3Institute of Pharmaceutical Technology, Goethe University Frankfurt, Frankfurt, Germany; 4Global Research and Development, AbbVie Inc., North Chicago, IL, USA *These authors contributed equally to this work Abstract: Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is

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

    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

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

    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

  7. Exploratory Practice and Soft Systems Methodology

    Tajino, Akira; Smith, Craig

    2005-01-01

    This paper aims to demonstrate that Soft Systems Methodology (SSM), a soft systems approach developed in management studies (see Checkland, 1981), can be usefully linked with Exploratory Practice (EP), a form of practitioner research for language classrooms. Some compatible SSM and EP characteristics, in tandem, could enhance continual efforts to…

  8. Exploratory research and development FY90

    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

  9. Exploratory research and development FY90

    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.

  10. The Infinitesimal Jackknife with Exploratory Factor Analysis

    Zhang, Guangjian; Preacher, Kristopher J.; Jennrich, Robert I.

    2012-01-01

    The infinitesimal jackknife, a nonparametric method for estimating standard errors, has been used to obtain standard error estimates in covariance structure analysis. In this article, we adapt it for obtaining standard errors for rotated factor loadings and factor correlations in exploratory factor analysis with sample correlation matrices. Both…

  11. Exploratory shaft conceptual design report: Permian Basin

    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

  12. Exploratory shaft conceptual design report: Paradox Basin

    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

  13. 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

    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...

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

    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.

  15. Identifying and Synchronizing Health Information Technology (HIT) Events from FDA Medical Device Reports.

    Kang, Hong; Wang, Frank; Zhou, Sicheng; Miao, Qi; Gong, Yang

    2017-01-01

    Health information technology (HIT) events, a subtype of patient safety events, pose a major threat and barrier toward a safer healthcare system. It is crucial to gain a better understanding of the nature of the errors and adverse events caused by current HIT systems. The scarcity of HIT event-exclusive databases and event reporting systems indicates the challenge of identifying the HIT events from existing resources. FDA Manufacturer and User Facility Device Experience (MAUDE) database is a potential resource for HIT events. However, the low proportion and the rapid evolvement of HIT-related events present challenges for distinguishing them from other equipment failures and hazards. We proposed a strategy to identify and synchronize HIT events from MAUDE by using a filter based on structured features and classifiers based on unstructured features. The strategy will help us develop and grow an HIT event-exclusive database, keeping pace with updates to MAUDE toward shared learning.

  16. An analysis of FDA-approved drugs: natural products and their derivatives.

    Patridge, Eric; Gareiss, Peter; Kinch, Michael S; Hoyer, Denton

    2016-02-01

    Natural products contribute greatly to the history and landscape of new molecular entities (NMEs). An assessment of all FDA-approved NMEs reveals that natural products and their derivatives represent over one-third of all NMEs. Nearly one-half of these are derived from mammals, one-quarter from microbes and one-quarter from plants. Since the 1930s, the total fraction of natural products has diminished, whereas semisynthetic and synthetic natural product derivatives have increased. Over time, this fraction has also become enriched with microbial natural products, which represent a significant portion of approved antibiotics, including more than two-thirds of all antibacterial NMEs. In recent years, the declining focus on natural products has impacted the pipeline of NMEs from specific classes, and this trend is likely to continue without specific investment in the pursuit of natural products. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Chiron Vision files FDA application to market intraocular implant for CMV retinitis. Food and Drug Administration.

    1995-07-01

    Chiron Corporation and Hoffman-LaRoche announced a filing of a New Drug Application with the Food and Drug Administration (FDA) to market Vitrasert, its intraocular implant which delivers ganciclovir directly to the eye for treatment of CMV retinitis. Clinical trials show that Vitrasert offers a clinical improvement versus intravenous ganciclovir in further delaying progression of CMV retinitis in the treated eye. One study reported that the median time to progression of CMV retinitis was 186 days for eyes receiving Vitrasert compared to 72 days for eyes receiving intravenous ganciclovir therapy. Chiron's intraocular implant contains ganciclovir embedded in a polymer-based system that slowly releases the drug into the eye for up to eight months. Two additional trials are underway. For further information contact the Professional Services Group at Chiron Corporation at (800) 244-7668, select 2.

  18. An analysis of the FDA Food Safety Modernization Act: protection for consumers and boon for business.

    Strauss, Debra M

    2011-01-01

    This article analyzes components of the FDA Food Safety Modernization Act, which was prompted by incidents of food contamination, exploring the history of its passage and explaining its significance, as well as its limitations. As the first time in 70 years that food law has been changed substantially, this new law represents only an initial but significant step in the direction of improving food safety. With bipartisan support from both Congress and the President, this legislation embodies a mandate that food safety is at this moment becoming a priority. As a result, the time is ripe for a reassessment of other areas of food laws--particularly genetically modified foods and the use of milk and meat from cloned animals and their progeny--which are allowed under current U.S. law with no labeling, preapprovals, or post-market monitoring. These areas warrant special regulation consistent with the new proactive policy towards securing the safety of the food supply.

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

    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.

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

    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.

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

    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.

  2. QUADrATiC: scalable gene expression connectivity mapping for repurposing FDA-approved therapeutics.

    O'Reilly, Paul G; Wen, Qing; Bankhead, Peter; Dunne, Philip D; McArt, Darragh G; McPherson, Suzanne; Hamilton, Peter W; Mills, Ken I; Zhang, Shu-Dong

    2016-05-04

    Gene expression connectivity mapping has proven to be a powerful and flexible tool for research. Its application has been shown in a broad range of research topics, most commonly as a means of identifying potential small molecule compounds, which may be further investigated as candidates for repurposing to treat diseases. The public release of voluminous data from the Library of Integrated Cellular Signatures (LINCS) programme further enhanced the utilities and potentials of gene expression connectivity mapping in biomedicine. We describe QUADrATiC ( http://go.qub.ac.uk/QUADrATiC ), a user-friendly tool for the exploration of gene expression connectivity on the subset of the LINCS data set corresponding to FDA-approved small molecule compounds. It enables the identification of compounds for repurposing therapeutic potentials. The software is designed to cope with the increased volume of data over existing tools, by taking advantage of multicore computing architectures to provide a scalable solution, which may be installed and operated on a range of computers, from laptops to servers. This scalability is provided by the use of the modern concurrent programming paradigm provided by the Akka framework. The QUADrATiC Graphical User Interface (GUI) has been developed using advanced Javascript frameworks, providing novel visualization capabilities for further analysis of connections. There is also a web services interface, allowing integration with other programs or scripts. QUADrATiC has been shown to provide an improvement over existing connectivity map software, in terms of scope (based on the LINCS data set), applicability (using FDA-approved compounds), usability and speed. It offers potential to biological researchers to analyze transcriptional data and generate potential therapeutics for focussed study in the lab. QUADrATiC represents a step change in the process of investigating gene expression connectivity and provides more biologically-relevant results than

  3. The FDA guidance for industry on PROs: the point of view of a pharmaceutical company.

    Arpinelli, Fabio; Bamfi, Francesco

    2006-10-31

    The importance of the patients point of view on their health status is widely recognised. Patient-reported outcomes is a broad term encompassing a large variety of different health data reported by patients, as symptoms, functional status, Quality of Life and Health-Related Quality of Life. Measurements of Health-Related Quality of Life have been developed during many years of researches, and a lot of validated questionnaires exist. However, few attempts have been made to standardise the evaluation of instruments characteristics, no recommendations are made about interpretation on Health-Related Quality of Life results, especially regarding the clinical significance of a change leading a therapeutic approach. Moreover, the true value of Health-Related Quality of Life evaluations in clinical trials has not yet been completely defined. An important step towards a more structured and frequent use of Patient-Reported Outcomes in drug development is represented by the FDA Guidance, issued on February 2006. In our paper we aim to report some considerations on this Guidance. Our comments focus especially on the characteristics of instruments to use, the Minimal Important Difference, and the methods to calculate it. Furthermore, we present the advantages and opportunities of using the Patient-Reported Outcomes in drug development, as seen by a pharmaceutical company. The Patient-Reported Outcomes can provide additional data to make a drug more competitive than others of the same pharmacological class, and a well demonstrated positive impact on the patient' health status and daily life might allow a higher price and/or the inclusion in a reimbursement list. Applying extensively the FDA Guidance in the next trials could lead to a wider culture of subjective measurement, and to a greater consideration for the patient's opinions on his/her care. Moreover, prescribing doctors and payers could benefit from subjective information to better define the value of drugs.

  4. Comparison of FDA safety and efficacy data for KAMRA and Raindrop corneal inlays

    Majid Moshirfar

    2017-09-01

    Full Text Available AIM: To provide a side-by-side analysis of the summary of safety and effectiveness data (SSED submitted to the FDA for the KAMRA and Raindrop corneal inlays for the correction of presbyopia. METHODS: SSED reports submitted to the FDA for KAMRA and Raindrop were compared with respect to loss of corrected distance visual acuity (CDVA, adverse event rates, induction of astigmatism, retention of contrast sensitivity, stability of manifest refractive spherical equivalent (MRSE, and achieved monocular uncorrected near visual acuity (UNVA at 24mo. RESULTS: Totally 442/508 of KAMRA patients and 344/373 Raindrop patients remained enrolled in the clinical trials at 24mo. The proportion of KAMRA and Raindrop patients who lost ≥2 lines of CDVA at 24mo was 3.4% and 1%, respectively. The adverse event rate was comparable between the devices. No significant inductions of astigmatism were noted. Both technologies induced a transient myopic shift in MRSE followed by a hyperopic shift and subsequent stabilization. Totally 87% of KAMRA and 98% of Raindrop patients attained a monocular UNVA of J5 (20/40 or better at 24mo, 28% of KAMRA and 67% of Raindrop patients attained a monocular UNVA of J1 (20/20 or better at 24mo. CONCLUSION: Both devices can be considered safe and effective, however, the results of corneal inlay implantation are mixed, and long-term patient satisfaction will likely depend on subjective expectations about the capabilities of the inlays. Variability in surgical technique and postoperative care within and between the two clinical trials diminishes the comparative power of this article.

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

    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.

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

    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.

  7. Jóvenes indígenas y relatos sobre escolaridades en la Universidad Pedagógica Nacional

    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.

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

    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.

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

    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.

  10. 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.

    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.

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

    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.

  12. Avaliação da eficiência energética em uma indústria de painéis compensado

    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...

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

    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.

  14. An Exploratory Study: Assessment of Modeled Dioxin ...

    EPA has released an external review draft entitled, An Exploratory Study: Assessment of Modeled Dioxin Exposure in Ceramic Art Studios(External Review Draft). The public comment period and the external peer-review workshop are separate processes that provide opportunities for all interested parties to comment on the document. In addition to consideration by EPA, all public comments submitted in accordance with this notice will also be forwarded to EPA’s contractor for the external peer-review panel prior to the workshop. EPA has realeased this draft document solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination. The purpose of this report is to describe an exploratory investigation of potential dioxin exposures to artists/hobbyists who use ball clay to make pottery and related products.

  15. Exploratory shaft facility preliminary designs - Permian Basin

    1983-09-01

    The purpose of the Preliminary Design Report, Permian Basin, is to provide a description of the preliminary design for an Exploratory Shaft Facility in the Permian Basin, Texas. This issue of the report describes the preliminary design for constructing the exploratory shaft using the Large Hole Drilling method of construction and outlines the preliminary design and estimates of probable construction cost. The Preliminary Design Report is prepared to complement and summarize other documents that comprise the design at the preliminary stage of completion, December 1982. Other design documents include drawings, cost estimates and schedules. The preliminary design drawing package, which includes the construction schedule drawing, depicts the descriptions in this report. For reference, a list of the drawing titles and corresponding numbers are included in the Appendix. The report is divided into three principal sections: Design Basis, Facility Description, and Construction Cost Estimate. 30 references, 13 tables

  16. Subjetividades indígenas impuestas y desafiantes en el discurso televisivo

    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.

  17. La jurisdicción indígena en el Sistema Penal Acusatorio

    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.

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

    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.

  19. Literatura indígena para crianças: o desafio da interculturalidade

    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.

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

    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.

  1. Modeling and simulation for medical product development and evaluation : highlights from the FDA-C-Path-ISOP 2013 workshop

    Romero, Klaus; Sinha, Vikram; Allerheiligen, Sandra; Danhof, Meindert; Pinheiro, Jose; Kruhlak, Naomi; Wang, Yaning; Wang, Sue-Jane; Sauer, John-Michael; Marier, J. F.; Corrigan, Brian; Rogers, James; Heerspink, H. J. Lambers; Gumbo, Tawanda; Vis, Peter; Watkins, Paul; Morrison, Tina; Gillespie, William; Gordon, Mark Forrest; Stephenson, Diane; Hanna, Debra; Pfister, Marc; Lalonde, Richard; Colatsky, Thomas

    2014-01-01

    Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [1]. Priorities identified included the need for

  2. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    2011-07-14

    ...., Bldg. 51, rm. 2201, Silver Spring, MD 20993- 0002, or Office of Communication, Outreach and Development... help make critical treatment decisions. FDA oversight of companion diagnostics will protect patients... current thinking on companion diagnostic devices. It does not create or confer any rights for or on any...

  3. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? 1.383 Section 1.383 Food and Drugs FOOD AND... Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.383 What expedited...

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

    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.

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

    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.

  6. 76 FR 13643 - FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting

    2011-03-14

    ... Act: Title III--A New Paradigm for Importers; Public Meeting AGENCY: Food and Drug Administration, HHS... announcing a public meeting entitled ``FDA Food Safety Modernization Act: Title III--A New Paradigm for... provided. Request special accommodations due By March 22, 2011.... Patricia M. Kuntze, 301- to disability...

  7. Excavationless Exterior Foundation Insulation Exploratory Study

    Mosiman, G.; Wagner, R.; Schirber, T.

    2013-02-01

    The key objective of this exploratory study was to investigate the feasibility of the development or adoption of technologies that would enable a large percentage of existing homes in cold climates to apply a combination 'excavationless' soil removal process with appropriate insulation and water management on the exterior of existing foundations at a low cost. Our approach was to explore existing excavation and material technologies and systems to discover whether potential successful combinations existed.

  8. Fundamentals of exploratory analysis of variance

    Hoaglin, David C; Tukey, John W

    2009-01-01

    The analysis of variance is presented as an exploratory component of data analysis, while retaining the customary least squares fitting methods. Balanced data layouts are used to reveal key ideas and techniques for exploration. The approach emphasizes both the individual observations and the separate parts that the analysis produces. Most chapters include exercises and the appendices give selected percentage points of the Gaussian, t, F chi-squared and studentized range distributions.

  9. Planning representation for automated exploratory data analysis

    St. Amant, Robert; Cohen, Paul R.

    1994-03-01

    Igor is a knowledge-based system for exploratory statistical analysis of complex systems and environments. Igor has two related goals: to help automate the search for interesting patterns in data sets, and to help develop models that capture significant relationships in the data. We outline a language for Igor, based on techniques of opportunistic planning, which balances control and opportunism. We describe the application of Igor to the analysis of the behavior of Phoenix, an artificial intelligence planning system.

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

    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.

  11. Otolith dysfunction alters exploratory movement in mice.

    Blankenship, Philip A; Cherep, Lucia A; Donaldson, Tia N; Brockman, Sarah N; Trainer, Alexandria D; Yoder, Ryan M; Wallace, Douglas G

    2017-05-15

    The organization of rodent exploratory behavior appears to depend on self-movement cue processing. As of yet, however, no studies have directly examined the vestibular system's contribution to the organization of exploratory movement. The current study sequentially segmented open field behavior into progressions and stops in order to characterize differences in movement organization between control and otoconia-deficient tilted mice under conditions with and without access to visual cues. Under completely dark conditions, tilted mice exhibited similar distance traveled and stop times overall, but had significantly more circuitous progressions, larger changes in heading between progressions, and less stable clustering of home bases, relative to control mice. In light conditions, control and tilted mice were similar on all measures except for the change in heading between progressions. This pattern of results is consistent with otoconia-deficient tilted mice using visual cues to compensate for impaired self-movement cue processing. This work provides the first empirical evidence that signals from the otolithic organs mediate the organization of exploratory behavior, based on a novel assessment of spatial orientation. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Limites da autonomia e da autodefesa indígena: experiências mexicanas

    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

  13. IX. El Decenio Internacional de los Pueblos Indígenas del Mundo

    Tum, Rigoberta Menchú

    2014-01-01

    Han pasado más de 500 años de oscuridad, y hoy sabemos que éste es el tiempo de profundizar en la lucha por el nuevo amanecer que ha de alumbrar el futuro de nuestros pueblos. A lo largo de los últimos años, los pueblos indígenas hemos realizado importantes actividades a nivel nacional, regional y mundial promoviendo así una amplia discusión acerca del estado de nuestros derechos y de la recuperación de nuestra cultura milenaria. De la misma manera, también se hicieron esfuerzos coordinados a...

  14. Interação academia-indústria. Relato da experiência da Vale

    LUIZ EUGENIO A. M. MELLO

    Full Text Available RESUMO Abordamos aqui a nucleação de um modelo de inovação aberta na Vale (uma das maiores mineradoras do mundo apresentando o contexto histórico em que se deu esse processo. Discutimos algumas das questões que possivelmente haviam até então dificultado a implantação de uma estrutura de pesquisa e desenvolvimento focando o longo prazo pela indústria no Brasil. Destacamos algumas das dificuldades encontradas ao longo do processo, bem como algumas das razões que levaram ao sucesso da iniciativa.

  15. Når HRM sparker døren ind til fremtiden

    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....

  16. Suministro de agua domiciliar a tres comunidades indígenas, Guatemala

    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...

  17. Práticas de produção na indústria alimentar portuguesa

    Oliveira, Maria; Silva, G. M.

    2017-01-01

    A qualidade é um dos fatores críticos na indústria alimentar (IA), resultante da legislação, das exigências dos consumidores e da concorrência e, também o critério mais importante para conseguir a lealdade dos consumidores (Dora, Kumar, Van Goubergen, Molnar & Gellynck, 2013). Alguns estudos empíricos na IA evidenciam melhorias da qualidade e da eficiência decorrentes da implementação de práticas lean (e.g., Scott, Wilcock & Kanetkar, 2009; Van Goubergen, Dora, Molnar & Gellynck, 2011). O...

  18. Migración retornada y juventud indígena (Zacualpa, Guatemala)

    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...

  19. A indústria de fertilizantes químicos no Brasil

    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 ...

  20. Pluralismo jurídico: derecho indígena y justicia nacional

    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...

  1. Eficiência agronômica de rejeitos da indústria de fertilizantes fosfatados

    Garcia, Luciana de Arruda [UNESP

    2014-01-01

    A produção de fertilizantes fosfatados solúveis gera muitos rejeitos, cujo aproveitamento não é possível pelos atuais métodos industriais, acarretando perdas elevadas de P no beneficiamento, através da subutilização dos depósitos de fosfato, representando, portanto, um bem mineral não utilizado e um problema ambiental preocupante, devido aos grandes volumes envolvidos. Neste contexto, o objetivo deste trabalho foi avaliar a eficiência agronômica de dois rejeitos da indústria de fertilizantes ...

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

    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...

  3. The 2014 FDA assessment of commercial fish: practical considerations for improved dietary guidance.

    McGuire, Jennifer; Kaplan, Jason; Lapolla, John; Kleiner, Rima

    2016-07-13

    The U.S. Food and Drug Administration (FDA) recently released its report: A Quantitative Assessment of the Net Effects on Fetal Neurodevelopment from Eating Commercial Fish (As Measured by IQ and also by Early Age Verbal Development in Children). By evaluating the benefits and potential concerns of eating fish during pregnancy and breastfeeding, the analysis suggests that pregnant women consuming two seafood meals (8-12 oz) per week could provide their child with an additional 3.3 IQ points by age 9. Recent insights from behavioral economics research indicate that other factors, such as concerns about price and methylmercury (MeHg) exposure, appear to reduce fish consumption in many individuals.To assess the net effects of eating commercial fish during pregnancy, we compared the consumption of select fish species necessary to achieve IQ benefits with the amount necessary to have adverse developmental effects due to MeHg exposure. For the species or market types evaluated, the number of servings necessary to reach MeHg exposure to observe an adverse effect was at least twice that the amount estimated to achieve peak developmental benefit. We then reported average costs of fresh and canned or pouched fish, and calculated the cost per week for pregnant women to achieve maximum IQ benefits for their gestating child. Canned light tuna was the least expensive option at $1.83 per week to achieve maximum IQ benefit.Due to their relatively low cost, canned and pouched fish products eaten with enough regularity are likely to provide peak cognitive benefits. Because of its popularity, canned and pouched tuna could provide some of the largest cognitive benefits from fish consumption in the U.S. Future FDA consumer advice and related educational initiatives could benefit from a broader perspective that highlights the importance of affordable and accessible fish choices. These observations underscore the importance of clear public health messaging that address both health

  4. Investigating drug repositioning opportunities in FDA drug labels through topic modeling.

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

    2012-01-01

    Drug repositioning offers an opportunity to revitalize the slowing drug discovery pipeline by finding new uses for currently existing drugs. Our hypothesis is that drugs sharing similar side effect profiles are likely to be effective for the same disease, and thus repositioning opportunities can be identified by finding drug pairs with similar side effects documented in U.S. Food and Drug Administration (FDA) approved drug labels. The safety information in the drug labels is usually obtained in the clinical trial and augmented with the observations in the post-market use of the drug. Therefore, our drug repositioning approach can take the advantage of more comprehensive safety information comparing with conventional de novo approach. A probabilistic topic model was constructed based on the terms in the Medical Dictionary for Regulatory Activities (MedDRA) that appeared in the Boxed Warning, Warnings and Precautions, and Adverse Reactions sections of the labels of 870 drugs. Fifty-two unique topics, each containing a set of terms, were identified by using topic modeling. The resulting probabilistic topic associations were used to measure the distance (similarity) between drugs. The success of the proposed model was evaluated by comparing a drug and its nearest neighbor (i.e., a drug pair) for common indications found in the Indications and Usage Section of the drug labels. Given a drug with more than three indications, the model yielded a 75% recall, meaning 75% of drug pairs shared one or more common indications. This is significantly higher than the 22% recall rate achieved by random selection. Additionally, the recall rate grows rapidly as the number of drug indications increases and reaches 84% for drugs with 11 indications. The analysis also demonstrated that 65 drugs with a Boxed Warning, which indicates significant risk of serious and possibly life-threatening adverse effects, might be replaced with safer alternatives that do not have a Boxed Warning. In

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

    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.

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

    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.

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

    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...

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

    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...

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

    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...

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

    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.

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

    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.

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

    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.

  13. Los pueblos indígenas y la reforma del Estado en América Latina

    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.

  14. A History of the Sonocare CST-100: The First FDA-approved HIFU Device

    Muratore, Robert

    2006-05-01

    The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.

  15. Towards a Computational Analysis of Status and Leadership Styles on FDA Panels

    Broniatowski, David A.; Magee, Christopher L.

    Decisions by committees of technical experts are increasingly impacting society. These decision-makers are typically embedded within a web of social relations. Taken as a whole, these relations define an implicit social structure which can influence the decision outcome. Aspects of this structure are founded on interpersonal affinity between parties to the negotiation, on assigned roles, and on the recognition of status characteristics, such as relevant domain expertise. This paper build upon a methodology aimed at extracting an explicit representation of such social structures using meeting transcripts as a data source. Whereas earlier results demonstrated that the method presented here can identify groups of decision-makers with a contextual affinity (i.e., membership in a given medical specialty or voting clique), we now can extract meaningful status hierarchies, and can identify differing facilitation styles among committee chairs. Use of this method is demonstrated on the transcripts of U.S. Food and Drug Administration (FDA) advisory panel meeting transcripts; nevertheless, the approach presented here is extensible to other domains and requires only a meeting transcript as input.

  16. Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports

    Judith U. Cope

    2015-01-01

    Full Text Available Background. Ewing sarcoma family of tumors (ESFT are rare but deadly cancers of unknown etiology. Few risk factors have been identified. This study was undertaken to ascertain any possible association between exposure to therapeutic drugs and ESFT. Methods. This is a retrospective, descriptive study. A query of the FDA Adverse Event Reporting System (FAERS was conducted for all reports of ESFT, January 1, 1998, through December 31, 2013. Report narratives were individually reviewed for patient characteristics, underlying conditions and drug exposures. Results. Over 16 years, 134 ESFT reports were identified, including 25 cases of ESFT following therapeutic drugs and biologics including immunosuppressive agents and hormones. Many cases were confounded by concomitant medications and other therapies. Conclusions. This study provides a closer look at medication use and underlying disorders in patients who later developed ESFT. While this study was not designed to demonstrate any clear causative association between ESFT and prior use of a single product or drug class, many drugs were used to treat immune-related disease and growth or hormonal disturbances. Further studies may be warranted to better understand possible immune or neuroendocrine abnormalities or exposure to specific classes of drugs that may predispose to the later development of ESFT.

  17. Repurposing the FDA-approved pinworm drug pyrvinium as a novel chemotherapeutic agent for intestinal polyposis.

    Bin Li

    Full Text Available Mutations in the WNT-pathway regulator ADENOMATOUS POLYPOSIS COLI (APC promote aberrant activation of the WNT pathway that is responsible for APC-associated diseases such as Familial Adenomatous Polyposis (FAP and 85% of spontaneous colorectal cancers (CRC. FAP is characterized by multiple intestinal adenomas, which inexorably result in CRC. Surprisingly, given their common occurrence, there are few effective chemotherapeutic drugs for FAP. Here we show that the FDA-approved, anti-helminthic drug Pyrvinium attenuates the growth of WNT-dependent CRC cells and does so via activation of CK1α. Furthermore, we show that Pyrvinium can function as an in vivo inhibitor of WNT-signaling and polyposis in a mouse model of FAP: APCmin mice. Oral administration of Pyrvinium, a CK1α agonist, attenuated the levels of WNT-driven biomarkers and inhibited adenoma formation in APCmin mice. Considering its well-documented safe use for treating enterobiasis in humans, our findings suggest that Pyrvinium could be repurposed for the clinical treatment of APC-associated polyposes.

  18. Inhibition of Urease by Disulfiram, an FDA-Approved Thiol Reagent Used in Humans.

    Díaz-Sánchez, Ángel Gabriel; Alvarez-Parrilla, Emilio; Martínez-Martínez, Alejandro; Aguirre-Reyes, Luis; Orozpe-Olvera, Jesica Aline; Ramos-Soto, Miguel Armando; Núñez-Gastélum, José Alberto; Alvarado-Tenorio, Bonifacio; de la Rosa, Laura Alejandra

    2016-11-26

    Urease is a nickel-dependent amidohydrolase that catalyses the decomposition of urea into carbamate and ammonia, a reaction that constitutes an important source of nitrogen for bacteria, fungi and plants. It is recognized as a potential antimicrobial target with an impact on medicine, agriculture, and the environment. The list of possible urease inhibitors is continuously increasing, with a special interest in those that interact with and block the flexible active site flap. We show that disulfiram inhibits urease in Citrullus vulgaris (CVU), following a non-competitive mechanism, and may be one of this kind of inhibitors. Disulfiram is a well-known thiol reagent that has been approved by the FDA for treatment of chronic alcoholism. We also found that other thiol reactive compounds (l-captopril and Bithionol) and quercetin inhibits CVU. These inhibitors protect the enzyme against its full inactivation by the thiol-specific reagent Aldrithiol (2,2'-dipyridyl disulphide, DPS), suggesting that the three drugs bind to the same subsite. Enzyme kinetics, competing inhibition experiments, auto-fluorescence binding experiments, and docking suggest that the disulfiram reactive site is Cys592, which has been proposed as a "hinge" located in the flexible active site flap. This study presents the basis for the use of disulfiram as one potential inhibitor to control urease activity.

  19. Tamoxifen: an FDA approved drug with neuroprotective effects for spinal cord injury recovery

    Jennifer M Colón

    2016-01-01

    Full Text Available Spinal cord injury (SCI is a condition without a cure, affecting sensory and/or motor functions. The physical trauma to the spinal cord initiates a cascade of molecular and cellular events that generates a non-permissive environment for cell survival and axonal regeneration. Among these complex set of events are damage of the blood-brain barrier, edema formation, inflammation, oxidative stress, demyelination, reactive gliosis and apoptosis. The multiple events activated after SCI require a multi-active drug that could target most of these events and produce a permissive environment for cell survival, regeneration, vascular reorganization and synaptic formation. Tamoxifen, a selective estrogen receptor modulator, is an FDA approved drug with several neuroprotective properties that should be considered for the treatment of this devastating condition. Various investigators using different animal models and injury parameters have demonstrated the beneficial effects of this drug to improve functional locomotor recovery after SCI. Results suggest that the mechanism of action of Tamoxifen administration is to modulate anti-oxidant, anti-inflammatory and anti-gliotic responses. A gap of knowledge exists regarding the sex differences in response to Tamoxifen and the therapeutic window available to administer this treatment. In addition, the effects of Tamoxifen in axonal outgrowth or synapse formation needs to be investigated. This review will address some of the mechanisms activated by Tamoxifen after SCI and the results recently published by investigators in the field.

  20. The informational turn in food politics: The US FDA's nutrition label as information infrastructure.

    Frohlich, Xaq

    2017-04-01

    This article traces the history of the US FDA regulation of nutrition labeling, identifying an 'informational turn' in the evolving politics of food, diet and health in America. Before nutrition labeling was introduced, regulators actively sought to segregate food markets from drug markets by largely prohibiting health information on food labels, believing such information would 'confuse' the ordinary food consumer. Nutrition labeling's emergence, first in the 1970s as consumer empowerment and then later in the 1990s as a solution to information overload, reflected the belief that it was better to manage markets indirectly through consumer information than directly through command-and-control regulatory architecture. By studying product labels as 'information infrastructure', rather than a 'knowledge fix', the article shows how labels are situated at the center of a legally constructed terrain of inter-textual references, both educational and promotional, that reflects a mix of market pragmatism and evolving legal thought about mass versus niche markets. A change to the label reaches out across a wide informational environment representing food and has direct material consequences for how food is produced, distributed, and consumed. One legacy of this informational turn has been an increasing focus by policymakers, industry, and arguably consumers on the politics of information in place of the politics of the food itself.

  1. Bringing smart pills to market: FDA regulation of ingestible drug/device combination products.

    Avery, Matthew; Liu, Dan

    2011-01-01

    Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills like this already exist. These so-called smart pills are an emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges. This article predicts how the Food and Drug Administration will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their "novel mode of action" rather than their "primary mode of action," (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products.

  2. Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System.

    Sanagawa, Akimasa; Hotta, Yuji; Kataoka, Tomoya; Maeda, Yasuhiro; Kondo, Masahiro; Kawade, Yoshihiro; Ogawa, Yoshihiro; Nishikawa, Ryohei; Tohkin, Masahiro; Kimura, Kazunori

    2018-04-16

    We conducted data mining using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database on spontaneously reported adverse events to evaluate the association between anticancer drug therapy and hepatitis B infection. Reports of hepatitis B infection were retrieved from the FAERS database. The reporting odds ratio (ROR) was used to estimate the association between hepatitis B infection and various anticancer agents and drug combinations. We detected statistically significant risk signals of hepatitis B for 33 of 64 anticancer agents by ROR (26 cytotoxicity drugs and seven molecular-targeted drugs). We focused on molecular-targeted drugs and assessed the risk of hepatitis B from specific anticancer drug combinations. The frequency of hepatitis B infection was significantly high for drugs such as rituximab, bortezomib, imatinib, and everolimus. The addition of cyclophosphamide, doxorubicin, and fludarabine to drug combinations additively enhanced the frequency of hepatitis B infection. There were no reports on hepatitis B infection associated with trastuzumab or azacitidine monotherapy. However, trastuzumab-containing regimens (e.g., combinations with docetaxel or paclitaxel) were correlated with the incidence of hepatitis B infection, similar to azacitidine monotherapy. Our findings suggest that the concomitant use of anticancer drugs, such as trastuzumab, taxane, and azacitidine, may contribute to the risk of hepatitis B infection. The unique signals detected from the public database might provide clues to eliminate the threat of HBV in oncology. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  3. The analysis of the market success of FDA approvals by probing top 100 bestselling drugs

    Polanski, Jaroslaw; Bogocz, Jacek; Tkocz, Aleksandra

    2016-05-01

    Target-oriented drug discovery is the main research paradigm of contemporary drug discovery. In target-oriented approaches, we attempt to maximize in vitro drug potency by finding the optimal fit to the target. This can result in a higher molecular complexity, in particular, the higher molecular weight (MW) of the drugs. However, a comparison of the successful developments of pharmaceuticals with the general trends that can be observed in medicinal chemistry resulted in the conclusion that the so-called molecular obesity is an important reason for the attrition rate of drugs. When analyzing the list of top 100 drug bestsellers versus all of the FDA approvals, we discovered that on average lower-complexity (MW, ADMET score) drugs are winners of the top 100 list in terms of numbers but that, especially, up to some optimal MW value, a higher molecular complexity can pay off with higher incomes. This indicates that slim drugs are doing better but that fat drugs are bigger fishes to catch.

  4. Security and privacy qualities of medical devices: an analysis of FDA postmarket surveillance.

    Kramer, Daniel B; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R

    2012-01-01

    Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.

  5. Cloned animal products in the human food chain: FDA should protect American consumers.

    Butler, Jennifer E F

    2009-01-01

    Animal cloning is "complex process that lets one exactly copy the genetic, or inherited, traits of an animal." In 1997, Dolly the sheep was the first animal cloned and since then "scientists have used animal cloning to breed dairy cows, beef cattle, poultry, hogs and other species of livestock." Cloned animals are highly attractive to livestock breeders because "cloning essentially produces an identical copy of an animal with superior traits." The main purpose of cloning livestock is "more focused on efficiency and economic benefits of the producer rather than the overall effect of cloning on an animal's physical and mental welfare." The focus of this article is threefold. First, the science behind animal cloning is explained and some potential uses and risks of this technology are explored. Second, FDA's historical evolution, current regulatory authority, and limitations of that authority, is described. Lastly, a new regulatory vision recognizes the realities of 21st century global markets and the dynamic evolution of scientific discovery and technology.

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

    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.

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

    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.

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

    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.

  9. Marketing verde e práticas socioambientais nas indústrias do Paraná

    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.

  10. Pueblos indígenas, Estado y Territorio en tiempos interculturales en la provincia de Salta

    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.

  11. Turismo rural y desarrollo territorial en espacios indígenas de México

    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.

  12. Los mayas del altiplano: supervivencia indígena en Chiapas y Guatemala

    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.

  13. Spatial Interaction Modeling to Identify Potentially Exposed Populations during RDD or IND Terrorism Incidents

    Regens, J.L.; Gunter, J.T.; Gupta, S.

    2009-01-01

    Homeland Security Presidential Directive no.5 (HSPD-5) Management of Domestic Incidents and Department of Homeland Security (DHS) Planning Guidance for Protection and Recovery Following Radiological Dispersal Device (RDD) and Improvised Nuclear Device (IND) Incidents underscore the need to delineate radiological emergency guidance applicable to remedial action and recovery following an RDD or IND incident. Rapid delineation of the population potentially exposed to ionizing radiation from fallout during terrorist incidents involving RDDs or low-yield nuclear devices (≤ 20 KT) is necessary for effective medical response and incident management as part of the recovery process. This paper illustrates the application of spatial interaction models to allocate population data for a representative U.S. urban area (≅1.3M people; 1,612.27 km 2 area) at a geographical scale relevant for accurately estimating risk given dose concentrations. Estimated total dose equivalents (TEDE) are calculated for isopleths moving away from the detonation point for typical release scenarios. Population is estimated within the TEDE zones using Euclidean distances between zip code polygon centroids generated in ArcGIS version 9.1 with distance decay determined by regression analysis to apportion origin-destination pairs to a population count and density matrix on a spatial basis for daytime and night-time release scenarios. (authors)

  14. Bravura Indômita: entre a fábula e a trama

    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.

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

    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.

  16. First detection of foot-and-mouth disease virus O/Ind-2001d in Vietnam.

    Vu, Le T; Long, Ngo T; Brito, Barbara; Stenfeldt, Carolina; Phuong, Nguyen T; Hoang, Bui H; Pauszek, Steven J; Hartwig, Ethan J; Smoliga, George R; Vu, Pham P; Quang, Le T V; Hung, Vo V; Tho, Nguyen D; Dong, Pham V; Minh, Phan Q; Bertram, Miranda; Fish, Ian H; Rodriguez, Luis L; Dung, Do H; Arzt, Jonathan

    2017-01-01

    In recent years, foot-and-mouth disease virus (FMDV) serotype O, topotype Middle East-South Asia (ME-SA), lineage Ind-2001d has spread from the Indian subcontinent to the Middle East, North Africa, and Southeast Asia. In the current report, we describe the first detection of this lineage in Vietnam in May, 2015 in Đắk Nông province. Three subsequent outbreaks caused by genetically related viruses occurred between May-October, 2015 after which the virus was not detected in clinical outbreaks for at least 15 subsequent months. The observed outbreaks affected (in chronological order): cattle in Đắk Nông province, pigs in Đắk Lắk province and Đắk Nông province, and cattle in Ninh Thuận province. The clinical syndromes associated with these outbreaks were consistent with typical FMD in the affected species. Overall attack rate on affected premises was 0.85 in pigs and 0.93 in cattle over the course of the outbreak. Amongst 378 pigs at risk on affected premises, 85 pigs died during the outbreaks; there were no deaths among cattle. The manner in which FMDV/O/ME-SA/Ind-2001d was introduced into Vietnam remains undetermined; however, movement of live cattle is the suspected route. This incursion has substantial implications for epidemiology and control of FMD in Southeast Asia.

  17. Tambos de Filosofía Indígenas: la perspectiva de la nosotridad

    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

  18. Educación en el medio indígena de Chihuahua

    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.

  19. New Age en Colombia y la búsqueda de la espiritualidad indígena

    Jean -Paul Sarrazin

    2012-01-01

    Full Text Available New A ge e N C olombi A y la búsqueda de la espiritualidad indígena J ean -P aul S arrazin i nve S tigador g ru P o de a ntro P ología S ocial , icanh P rofe S or de antro P ología en la u niver S idad de lo S a nde S jsarrazin@icanh.gov.co Resumen E l objetivo general de este artículo es mostrar algunas de las características más im portantes de lo que podemos llamar (no sin controversia el fenómeno New Age en Colombia. Aunque la literatura sobre este fenómeno en el país brilla por su ausencia, no es así en otros países latinoamericanos, y no se puede pensar que Colombia sea la excepción a la difusión de un fenómeno globalizado como este. Obviamente, en cada lugar lo New Age tiene particularidades locales; en Colombia una de ellas es que sus discursos y prácticas han contribuido a imaginar a los indígenas colombianos como poseedores de una cierta espiritualidad. En esta ideología se mezclan universalismo y esencialismo, pluralismo e individualismo, tradicionalismo e innovación, combi naciones aparentemente contradictorias que son analizadas aquí.

  20. Autobiografia e sujeito histórico indígena: considerações preliminares

    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.

  1. Prevalencia de diabetes mellitus e hiperlipidemias en indígenas otomíes

    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

  2. Literatura, indústria cultural e formação humana

    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.

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

    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.

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

    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.

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

    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 ...

  6. Educação Escolar Indígena - A prática docente dos Guarani Mbya

    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

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

    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 ...

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

    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.

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

    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...

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

    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...

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

    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...

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

    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...

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

    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...

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

    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...

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

    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...

  16. Cestaria e a história de vida dos artesãos indígenas da Terra Indígena Xapecó

    Tanabi Sufiatti

    2013-03-01

    Full Text Available Cada povo culturalmente distinto possui habilidades e formas de materializar as necessidades do dia a dia ou dos rituais em diferentes artefatos: a cerâmica, a cestaria, os instrumentos musicais, os pequenos adornos, a arquitetura e toda a cultura material dos povos nativos estão carregados de princípios, objetivos, conhecimentos, história e valores. Com esta perspectiva fomos motivadas a desenvolver nosso trabalho de pesquisa com o povo Kaingang, especificamente, com artesãos da Terra Indígena Xapecó, em Ipuaçu - Brasil (SC, para conhecer sua história, sua cultura e seus saberes. Buscando contribuir para a valorização, divulgação e preservação de seus conhecimentos, inclusive os conhecimentos matemáticos – outras matemáticas dos povos culturalmente distintos. Desenvolvemos um estudo sobre saberes matemáticos em prática e cestarias dos Kaingang. Como resultado, apresentamos a seleção de grafismos sobre os quais apresentamos significados na cosmologia dualista kaingang e a identificação de propriedades geométricas da matemática escolar. O estudo foi desenvolvido através de pesquisa bibliográfica e de campo, com observação participante e teve como principal ferramenta teórica a etnomatemática.

  17. Exploratory Talk in the Early Years: Analysing Exploratory Talk in Collaborative Group Activities Involving Younger Learners

    Patterson, Eira Wyn

    2018-01-01

    Collaborative group work has the potential for providing rich opportunities for children to learn through talk with peers; however, in practice, little effective engagement in learning is observed within authentic learning contexts. Exploratory talk is associated with high levels of cognitive challenge within collaborative group work. Detailed…

  18. Functional analysis of the exploratory studies facility

    Duffy, M.A.; Mozhi, T.A.; Kumar, P.N.; Senderling, M.S.; Lemeshewsky, W.A.

    1993-01-01

    The 'Physical System Requirements - Exploratory Studies Facility' (PSR-ESF) was developed as part of an improved management structure and procedure initiative by the OCRWM for managing the disposal of spent nuclear fuel and high-level radioactive wastes. This paper discusses the development of the PSR-EF document. Based on a functional analysis approach, this document includes results in the form of boundary diagrams, function hierarchy trees, function description tables containing a compilation of requirements, architecture tree and tables, and functional flow diagrams. The approach used ensures the flowdown and traceability of relevant requirements for the ESF design process

  19. Exploratory Shaft Facility design basis study report

    Langstaff, A.L.

    1987-01-01

    The Design Basis Study is a scoping/sizing study that evaluated the items concerning the Exploratory Shaft Facility Design including design basis values for water and methane inflow; flexibility of the design to support potential changes in program direction; cost and schedule impacts that could result if the design were changed to comply with gassy mine regulations; and cost, schedule, advantages and disadvantages of a larger second shaft. Recommendations are proposed concerning water and methane inflow values, facility layout, second shaft size, ventilation, and gassy mine requirements. 75 refs., 3 figs., 7 tabs

  20. An experimental investigation of masking in the US FDA adverse event reporting system database.

    Wang, Hsin-wei; Hochberg, Alan M; Pearson, Ronald K; Hauben, Manfred

    2010-12-01

    A phenomenon of 'masking' or 'cloaking' in pharmacovigilance data mining has been described, which can potentially cause signals of disproportionate reporting (SDRs) to be missed, particularly in pharmaceutical company databases. Masking has been predicted theoretically, observed anecdotally or studied to a limited extent in both pharmaceutical company and health authority databases, but no previous publication systematically assesses its occurrence in a large health authority database. To explore the nature, extent and possible consequences of masking in the US FDA Adverse Event Reporting System (AERS) database by applying various experimental unmasking protocols to a set of drugs and events representing realistic pharmacovigilance analysis conditions. This study employed AERS data from 2001 through 2005. For a set of 63 Medical Dictionary for Regulatory Activities (MedDRA®) Preferred Terms (PTs), disproportionality analysis was carried out with respect to all drugs included in the AERS database, using a previously described urn-model-based algorithm. We specifically sought masking in which drug removal induced an increase in the statistical representation of a drug-event combination (DEC) that resulted in the emergence of a new SDR. We performed a series of unmasking experiments selecting drugs for removal using rational statistical decision rules based on the requirement of a reporting ratio (RR) >1, top-ranked statistical unexpectedness (SU) and relatedness as reflected in the WHO Anatomical Therapeutic Chemical level 4 (ATC4) grouping. In order to assess the possible extent of residual masking we performed two supplemental purely empirical analyses on a limited subset of data. This entailed testing every drug and drug group to determine which was most influential in uncovering masked SDRs. We assessed the strength of external evidence for a causal association for a small number of masked SDRs involving a subset of 29 drugs for which level of evidence

  1. Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance

    Kramer, Daniel B.; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R.

    2012-01-01

    Background Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware. PMID:22829874

  2. Monitoring Antimicrobial Resistance in the Food Supply Chain and Its Implications for FDA Policy Initiatives.

    Zawack, Kelson; Li, Min; Booth, James G; Love, Will; Lanzas, Cristina; Gröhn, Yrjö T

    2016-09-01

    In response to concerning increases in antimicrobial resistance (AMR), the Food and Drug Administration (FDA) has decided to increase veterinary oversight requirements for antimicrobials and restrict their use in growth promotion. Given the high stakes of this policy for the food supply, economy, and human and veterinary health, it is important to rigorously assess the effects of this policy. We have undertaken a detailed analysis of data provided by the National Antimicrobial Resistance Monitoring System (NARMS). We examined the trends in both AMR proportion and MIC between 2004 and 2012 at slaughter and retail stages. We investigated the makeup of variation in these data and estimated the sample and effect size requirements necessary to distinguish an effect of the policy change. Finally, we applied our approach to take a detailed look at the 2005 withdrawal of approval for the fluoroquinolone enrofloxacin in poultry water. Slaughter and retail showed similar trends. Both AMR proportion and MIC were valuable in assessing AMR, capturing different information. Most variation was within years, not between years, and accounting for geographic location explained little additional variation. At current rates of data collection, a 1-fold change in MIC should be detectable in 5 years and a 6% decrease in percent resistance could be detected in 6 years following establishment of a new resistance rate. Analysis of the enrofloxacin policy change showed the complexities of the AMR policy with no statistically significant change in resistance of both Campylobacter jejuni and Campylobacter coli to ciprofloxacin, another second-generation fluoroquinolone. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  3. A Systematic Screen of FDA-Approved Drugs for Inhibitors of Biological Threat Agents

    Madrid, Peter B.; Chopra, Sidharth; Manger, Ian D.; Gilfillan, Lynne; Keepers, Tiffany R.; Shurtleff, Amy C.; Green, Carol E.; Iyer, Lalitha V.; Dilks, Holli Hutcheson; Davey, Robert A.; Kolokoltsov, Andrey A.; Carrion, Ricardo; Patterson, Jean L.; Bavari, Sina; Panchal, Rekha G.; Warren, Travis K.; Wells, Jay B.; Moos, Walter H.; Burke, RaeLyn L.; Tanga, Mary J.

    2013-01-01

    Background The rapid development of effective medical countermeasures against potential biological threat agents is vital. Repurposing existing drugs that may have unanticipated activities as potential countermeasures is one way to meet this important goal, since currently approved drugs already have well-established safety and pharmacokinetic profiles in patients, as well as manufacturing and distribution networks. Therefore, approved drugs could rapidly be made available for a new indication in an emergency. Methodology/Principal Findings A large systematic effort to determine whether existing drugs can be used against high containment bacterial and viral pathogens is described. We assembled and screened 1012 FDA-approved drugs for off-label broad-spectrum efficacy against Bacillus anthracis; Francisella tularensis; Coxiella burnetii; and Ebola, Marburg, and Lassa fever viruses using in vitro cell culture assays. We found a variety of hits against two or more of these biological threat pathogens, which were validated in secondary assays. As expected, antibiotic compounds were highly active against bacterial agents, but we did not identify any non-antibiotic compounds with broad-spectrum antibacterial activity. Lomefloxacin and erythromycin were found to be the most potent compounds in vivo protecting mice against Bacillus anthracis challenge. While multiple virus-specific inhibitors were identified, the most noteworthy antiviral compound identified was chloroquine, which disrupted entry and replication of two or more viruses in vitro and protected mice against Ebola virus challenge in vivo. Conclusions/Significance The feasibility of repurposing existing drugs to face novel threats is demonstrated and this represents the first effort to apply this approach to high containment bacteria and viruses. PMID:23577127

  4. A systematic screen of FDA-approved drugs for inhibitors of biological threat agents.

    Peter B Madrid

    Full Text Available BACKGROUND: The rapid development of effective medical countermeasures against potential biological threat agents is vital. Repurposing existing drugs that may have unanticipated activities as potential countermeasures is one way to meet this important goal, since currently approved drugs already have well-established safety and pharmacokinetic profiles in patients, as well as manufacturing and distribution networks. Therefore, approved drugs could rapidly be made available for a new indication in an emergency. METHODOLOGY/PRINCIPAL FINDINGS: A large systematic effort to determine whether existing drugs can be used against high containment bacterial and viral pathogens is described. We assembled and screened 1012 FDA-approved drugs for off-label broad-spectrum efficacy against Bacillus anthracis; Francisella tularensis; Coxiella burnetii; and Ebola, Marburg, and Lassa fever viruses using in vitro cell culture assays. We found a variety of hits against two or more of these biological threat pathogens, which were validated in secondary assays. As expected, antibiotic compounds were highly active against bacterial agents, but we did not identify any non-antibiotic compounds with broad-spectrum antibacterial activity. Lomefloxacin and erythromycin were found to be the most potent compounds in vivo protecting mice against Bacillus anthracis challenge. While multiple virus-specific inhibitors were identified, the most noteworthy antiviral compound identified was chloroquine, which disrupted entry and replication of two or more viruses in vitro and protected mice against Ebola virus challenge in vivo. CONCLUSIONS/SIGNIFICANCE: The feasibility of repurposing existing drugs to face novel threats is demonstrated and this represents the first effort to apply this approach to high containment bacteria and viruses.

  5. Effects of 31 FDA approved small-molecule kinase inhibitors on isolated rat liver mitochondria.

    Zhang, Jun; Salminen, Alec; Yang, Xi; Luo, Yong; Wu, Qiangen; White, Matthew; Greenhaw, James; Ren, Lijun; Bryant, Matthew; Salminen, William; Papoian, Thomas; Mattes, William; Shi, Qiang

    2017-08-01

    The FDA has approved 31 small-molecule kinase inhibitors (KIs) for human use as of November 2016, with six having black box warnings for hepatotoxicity (BBW-H) in product labeling. The precise mechanisms and risk factors for KI-induced hepatotoxicity are poorly understood. Here, the 31 KIs were tested in isolated rat liver mitochondria, an in vitro system recently proposed to be a useful tool to predict drug-induced hepatotoxicity in humans. The KIs were incubated with mitochondria or submitochondrial particles at concentrations ranging from therapeutic maximal blood concentrations (Cmax) levels to 100-fold Cmax levels. Ten endpoints were measured, including oxygen consumption rate, inner membrane potential, cytochrome c release, swelling, reactive oxygen species, and individual respiratory chain complex (I-V) activities. Of the 31 KIs examined only three including sorafenib, regorafenib and pazopanib, all of which are hepatotoxic, caused significant mitochondrial toxicity at concentrations equal to the Cmax, indicating that mitochondrial toxicity likely contributes to the pathogenesis of hepatotoxicity associated with these KIs. At concentrations equal to 100-fold Cmax, 18 KIs were found to be toxic to mitochondria, and among six KIs with BBW-H, mitochondrial injury was induced by regorafenib, lapatinib, idelalisib, and pazopanib, but not ponatinib, or sunitinib. Mitochondrial liability at 100-fold Cmax had a positive predictive power (PPV) of 72% and negative predictive power (NPV) of 33% in predicting human KI hepatotoxicity as defined by product labeling, with the sensitivity and specificity being 62% and 44%, respectively. Similar predictive power was obtained using the criterion of Cmax ≥1.1 µM or daily dose ≥100 mg. Mitochondrial liability at 1-2.5-fold Cmax showed a 100% PPV and specificity, though the NPV and sensitivity were 32% and 14%, respectively. These data provide novel mechanistic insights into KI hepatotoxicity and indicate that

  6. Identification of Additional Anti-Persister Activity against Borrelia burgdorferi from an FDA Drug Library

    Jie Feng

    2015-09-01

    Full Text Available Lyme disease is a leading vector-borne disease in the United States. Although the majority of Lyme patients can be cured with standard 2–4 week antibiotic treatment, 10%–20% of patients continue to suffer from prolonged post-treatment Lyme disease syndrome (PTLDS. While the cause for this is unclear, persisting organisms not killed by current Lyme antibiotics may be involved. In our previous study, we screened an FDA drug library and reported 27 top hits that showed high activity against Borrelia persisters. In this study, we present the results of an additional 113 active hits that have higher activity against the stationary phase B. burgdorferi than the currently used Lyme antibiotics. Many antimicrobial agents (antibiotics, antivirals, antifungals, anthelmintics or antiparasitics used for treating other infections were found to have better activity than the current Lyme antibiotics. These include antibacterials such as rifamycins (3-formal-rifamycin, rifaximin, rifamycin SV, thiostrepton, quinolone drugs (sarafloxacin, clinafloxacin, tosufloxacin, and cell wall inhibitors carbenicillin, tazobactam, aztreonam; antifungal agents such as fluconazole, mepartricin, bifonazole, climbazole, oxiconazole, nystatin; antiviral agents zanamivir, nevirapine, tilorone; antimalarial agents artemisinin, methylene blue, and quidaldine blue; antihelmintic and antiparasitic agents toltrazuril, tartar emetic, potassium antimonyl tartrate trihydrate, oxantel, closantel, hycanthone, pyrimethamine, and tetramisole. Interestingly, drugs used for treating other non-infectious conditions including verteporfin, oltipraz, pyroglutamic acid, pidolic acid, and dextrorphan tartrate, that act on the glutathione/γ-glutamyl pathway involved in protection against free radical damage, and also the antidepressant drug indatraline, were found to have high activity against stationary phase B. burgdorferi. Among the active hits, agents that affect cell membranes, energy

  7. Identification of Additional Anti-Persister Activity against Borrelia burgdorferi from an FDA Drug Library.

    Feng, Jie; Weitner, Megan; Shi, Wanliang; Zhang, Shuo; Sullivan, David; Zhang, Ying

    2015-09-16

    Lyme disease is a leading vector-borne disease in the United States. Although the majority of Lyme patients can be cured with standard 2-4 week antibiotic treatment, 10%-20% of patients continue to suffer from prolonged post-treatment Lyme disease syndrome (PTLDS). While the cause for this is unclear, persisting organisms not killed by current Lyme antibiotics may be involved. In our previous study, we screened an FDA drug library and reported 27 top hits that showed high activity against Borrelia persisters. In this study, we present the results of an additional 113 active hits that have higher activity against the stationary phase B. burgdorferi than the currently used Lyme antibiotics. Many antimicrobial agents (antibiotics, antivirals, antifungals, anthelmintics or antiparasitics) used for treating other infections were found to have better activity than the current Lyme antibiotics. These include antibacterials such as rifamycins (3-formal-rifamycin, rifaximin, rifamycin SV), thiostrepton, quinolone drugs (sarafloxacin, clinafloxacin, tosufloxacin), and cell wall inhibitors carbenicillin, tazobactam, aztreonam; antifungal agents such as fluconazole, mepartricin, bifonazole, climbazole, oxiconazole, nystatin; antiviral agents zanamivir, nevirapine, tilorone; antimalarial agents artemisinin, methylene blue, and quidaldine blue; antihelmintic and antiparasitic agents toltrazuril, tartar emetic, potassium antimonyl tartrate trihydrate, oxantel, closantel, hycanthone, pyrimethamine, and tetramisole. Interestingly, drugs used for treating other non-infectious conditions including verteporfin, oltipraz, pyroglutamic acid, pidolic acid, and dextrorphan tartrate, that act on the glutathione/γ-glutamyl pathway involved in protection against free radical damage, and also the antidepressant drug indatraline, were found to have high activity against stationary phase B. burgdorferi. Among the active hits, agents that affect cell membranes, energy production, and reactive

  8. FDA-EPA Public Health Guidance on Fish Consumption: A Case Study on Informal Interagency Cooperation in "Shared Regulatory Space".

    Holden, Mark

    2015-01-01

    This article is a case study on how administrative agencies interact with each other in cases of shared regulatory jurisdiction. The theoretical literature on the topic of overlapping jurisdiction both (1) makes predictions about how agencies are expected to behave when they share jurisdiction, and (2) in recent iterations argues that overlapping jurisdiction can confer unique policymaking benefits. Through the lens of that theoretical literature, this article examines the relations between the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) regarding the public health risks posed by mercury in fish. It concludes that the FDA-EPA case study (1) corroborates the extant theoretical accounts of how agencies behave in cases of overlapping jurisdiction, (2) supports the conclusion of the recent scholarship that overlapping jurisdiction can confer unique policy benefits, and (3) reveals a few wrinkles not given adequate treatment in the extant literature.

  9. The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s-1970s.

    Shorter, Edward

    2008-01-01

    The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into "rogues," regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional "cop" agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.

  10. The first FDA marketing authorizations of next-generation sequencing technology and tests: challenges, solutions and impact for future assays.

    Bijwaard, Karen; Dickey, Jennifer S; Kelm, Kellie; Težak, Živana

    2015-01-01

    The rapid emergence and clinical translation of novel high-throughput sequencing technologies created a need to clarify the regulatory pathway for the evaluation and authorization of these unique technologies. Recently, the US FDA authorized for marketing four next generation sequencing (NGS)-based diagnostic devices which consisted of two heritable disease-specific assays, library preparation reagents and a NGS platform that are intended for human germline targeted sequencing from whole blood. These first authorizations can serve as a case study in how different types of NGS-based technology are reviewed by the FDA. In this manuscript we describe challenges associated with the evaluation of these novel technologies and provide an overview of what was reviewed. Besides making validated NGS-based devices available for in vitro diagnostic use, these first authorizations create a regulatory path for similar future instruments and assays.

  11. Estado de Salud infantil en las comunidades indígenas, afrocolombianas y aisladas en Colombia.

    Francisco Nuñez L.

    2002-04-01

    Full Text Available

    Se estima que Sur América en la época precolombina tenía entre 7 y 39 millones de habitantes(1. Como consecuencia del descubrimiento y la conquista de América la población indígena fue diezmada en gran proporción; entre las causas adicionales que explican esta disminución en la población, se encuentran múltiples patologías de diverso origen. A pesar de la reducción importante de las poblaciones aisladas Colombia cuenta hoy con una amplia diversidad étnica que motivó al Instituto de Genética Humana de la Universidad Javeriana, con su proyecto de Expedición Humana (EH, a indagar sobre los problemas que afectan estos grupos humanos.

    Para cumplir este propósito los objetivos planteados fueron: realzar con elementos científicos la diversidad humana y cultural de nuestro país, prestar atención primaria en salud a las comunidades indígenas y afro colombianas diagnosticando sus principales problemas de salud e impulsando el desarrollo de proyectos que permitan el acceso de estas comunidades a los servicios de salud. Buscó también respuestas que puedan hacer aportes importantes al conocimiento universal para generar una conciencia de nuestra identidad biológica y cultural.

    El objetivo de este estudio es describir la frecuencia de las enfermedades más comunes, el estado nutricional, los antecedentes médicos, familiares y los hallazgos de la evaluación oftalmológica practicada a niños entre 0 y 18 años pertenecientes a 37 comunidades indígenas, afro colombianas y aisladas en Colombia.

    El proyecto, en lo que atañe a la evaluación del estado de salud infantil, cumple con los propósitos generales de la Expedición Humana y busca explicar la diversidad humana colombiana vista a través de la población infantil perteneciente a los grupos étnicos aislados que inicialmente poblaron nuestro territorio...

  12. Les indéterminations augustiniennes. Gilson’s reading of the Augustinian thought

    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

  13. Infestación por triatominos en comunidades indígenas de Valledupar, Colombia

    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.

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

    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.

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

    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

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

    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.

  17. Exploratory portals of research data in education

    Di Blas Nicoletta

    2015-12-01

    Full Text Available This paper presents a powerful tool to enhance research in education: ‘exploratory portals’, supporting effective storage, sharing and exploration of large sets of research data. The workflow is the following: data are gathered by a research group; they are then classified according to a taxonomy (the one that best fits the group’s research interest; once uploaded in the portal, they can be ‘explored’ via a combination of faceted search (enriched by Boolean operators and data mining techniques. The system can thus answer in a few seconds to sophisticated user’s queries that otherwise would require hours; it can save a session’s results and materials for sharing with other scholars or for further investigation. The paper presents a case study of exploratory portal, dealing with data on (technology-based education. The portal has effectively been used by five different research groups, to run complex investigations of data about technology integration into schools.

  18. FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.

    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.

  19. Does the FDA have regulatory authority over adult autologous stem cell therapies? 21 CFR 1271 and the emperor's new clothes

    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.

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

    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.

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

    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.

  2. A clinical plan for MDMA (Ecstasy) in the treatment of posttraumatic stress disorder (PTSD): partnering with the FDA.

    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.

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

    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.

  4. Taenia saginata Goeze, 1872 (Platyhelminthes: Cestoda: Taeniidae en un indígena de Tierra del Fuego, Chile

    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.

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

    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.

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

    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.

  7. Literatura Inca (¿indígena? como representación de la literatura peruana

    Gonzalo Espino Relucé

    2011-05-01

    Full Text Available Esta comunicación propone la relación entre las bellas letras y las manifestacionesdiscursivas vinculadas al indio; por eso, esboza las principales ideasliterarias que Jorge Basadre propone en Equivocaciones y cuyo trazo se puedeleer en Historia de la República del Perú.1 Se detiene en la importancia de laLiteratura inca, compilación de Basadre, cuya publicación constituye un recuentode la literatura prehispánica, la producción colonial y republicana de laescritura literaria quechua como representación de lo indígena para las culturasperuanas. Lo vinculo, asimismo, a la comprensión de la literatura como ejercicioheterogéneo y a las formas como el indio es representado en la escritura a finalesde la primera mitad del siglo XX.

  8. Antropología del poder (Anuario de Estudios Indígenas (VV.AA.

    Sergio Daniel López

    2010-05-01

    Full Text Available Se puede afirmar que el estado mexicano de Chiapas es uno de los lugares más privilegiados, ricos y diversos para estudiar desde la disciplina antropológica el poder social. La variedad de culturas y lenguas encontradas dentro de fronteras comunes; las disputas centenarias sobre la legislación de las tierras; la mezcla de los modelos políticos occidentales que chocan o conviven con las organizaciones ejidales o los sistemas de cargos tradicionales; las revoluciones campesinas, la lucha por los derechos indígenas y el establecimiento de comunidades autónomas; el abuso, la corrupción y la apropiación del espacio político; la competencia religiosa por el liderazgo espiritual serían sólo algunos ejemplos de las temáticas que sirven como objeto de estudio disciplinar en esta fascinante región.

  9. Indústria de tabaco e cidadania: confronto entre redes organizacionais

    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...

  10. Articulações políticas indígenas no sul da Bahia

    Freire, Ricardo Sallum

    2016-01-01

    Os povos indígenas no Brasil têm se organizado social e politicamente diante dos atuais desafios impostos à reapropriação de seus territórios tradicionais e à manutenção dos direitos até então conquistados. No período histórico presente, em que se configura amplamente um meio geográfico técnico-científico-informacional, suas disputas territoriais ganham novos contornos e significados. Inseridos nesse contexto, os povos Tupinambá, Pataxó e Pataxó Hãhãhãe, no sul da Bahia, vêm constituindo sign...

  11. INdAM Meeting on Homological and Computational Methods in Commutative Algebra

    Gubeladze, Joseph; Römer, Tim

    2017-01-01

    This volume collects contributions by leading experts in the area of commutative algebra related to the  INdAM meeting “Homological and Computational Methods in Commutative Algebra” held in Cortona (Italy) from May 30 to  June 3, 2016 . The conference and this volume are dedicated to Winfried Bruns on the occasion of his 70th birthday. In particular, the topics of this book strongly reflect the variety of Winfried Bruns’ research interests and his great impact on commutative algebra as well as its applications to related fields. The authors discuss recent and relevant developments in algebraic geometry, commutative algebra, computational algebra, discrete geometry and homological algebra. The book offers a unique resource, both for young and more experienced researchers seeking comprehensive overviews and extensive bibliographic references.

  12. Arte, Indústria Cultural e educação

    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.

  13. Densité de population et systèmes agricoles en Inde

    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.

  14. La vejez indígena. El caso de los zoques del noroeste chiapaneco

    Laureano Reyes Gómez

    1999-01-01

    Full Text Available En este artículo se confrontan los cambios socioculturales experimentados al interior de la comunidad indígena zoque y se analizan las relaciones con los viejos, en términos del impacto que ha sufrido la cultura del grupo cuando han sido cambiados algunos de sus valores económicos y demográficos. La vejez es vista, entonces, no ya desde una perspectiva idílica, sino de una forma más ambivalente, combinada con extrema pobreza, un rápido crecimiento de la población de viejos, el debilitamiento de las estructuras tradicionales en las que descansa el poder de los viejos y la lucha generacional que se da al interior de la comunidad.

  15. Le Kāmasūtra et la « pulsion shastrique » en Inde

    Naudou, Elizabeth

    2013-01-01

    Le mot « shastrique » fait référence au traité (śāstra) d’où sont issus les Kāmasūtra, (plus généralement appelé le Kāmasūtra), « aphorismes sur l’amour » : le Kāmaśāstra, « traité sur l’amour ». Qui dit śāstra, dit, en Inde, exposé religieux ou scientifique, d’où l’expression « pulsion shastrique » que l’on pourrait rendre par « pulsion encyclopédique énumérative et classificatoire ». Le but de cet exposé est de replacer le texte dans cette structure mentale typiquement indienne, qui reflète...

  16. INdAM conference "CoMeTA 2013 - Combinatorial Methods in Topology and Algebra"

    Delucchi, Emanuele; Moci, Luca

    2015-01-01

    Combinatorics plays a prominent role in contemporary mathematics, due to the vibrant development it has experienced in the last two decades and its many interactions with other subjects. This book arises from the INdAM conference "CoMeTA 2013 - Combinatorial Methods in Topology and Algebra,'' which was held in Cortona in September 2013. The event brought together emerging and leading researchers at the crossroads of Combinatorics, Topology and Algebra, with a particular focus on new trends in subjects such as: hyperplane arrangements; discrete geometry and combinatorial topology; polytope theory and triangulations of manifolds; combinatorial algebraic geometry and commutative algebra; algebraic combinatorics; and combinatorial representation theory. The book is divided into two parts. The first expands on the topics discussed at the conference by providing additional background and explanations, while the second presents original contributions on new trends in the topics addressed by the conference.

  17. Métrica de la literatura sobre los indígenas de México

    Cristina Restrepo-Arango; Rubén Urbizagástegui-Alvarado

    2016-01-01

    http://dx.doi.org/10.5007/1518-2924.2016v21n46p104 Se analizan las características demográficas, crecimiento y productividad de la literatura publicada sobre los pueblos indígenas de México e indizada en Web of Science y Scopus. Se encontraron 2,457 trabajos publicados, sobre todo en revistas académicas (94%) y reseñas de libros (25.5%) en idioma inglés (89%). 732 títulos de revistas que publicaron un total de 1,642 artículos y se identificaron 9 títulos de revistas en la zona núcleo, ent...

  18. O mercado e as possibilidades da indústria de biofármacos no Brasil

    Renata Leite Tanaka; Maria Cristina Sanches Amorim

    2014-01-01

    Na última década, a produção de biofármacos é uma estratégia da grande empresa farmacêutica em todo o mundo. O desafio para o Estado brasileiro e para as organizações farmacêuticas nacionais é participar desse segmento em franca expansão e com efeitos importantes nas políticas públicas de medicamentos. As informações sobre o segmento encontram-se dispersas, assim, os objetivos do artigo são descrever o mercado no Brasil e apontar os principais debates sobre a inserção da indústria nacional na...

  19. Um Olhar Sobre a Indústria Musical: Limites e Possibilidades para uma Contra Hegemonia.

    Rebecca Nora

    2017-12-01

    Full Text Available Esse artigo tem como objetivo analisar o papel central que a Indústria Musical exerce enquanto sustentáculo da hegemonia burguesa, atualmente expressa pelo modo de produção racista-patriarcal-capitalista, bem como as mudanças ocorridas nesta devido à revolução digital. Esse trabalho se constitui sob o arcabouço teórico marxista, que à luz gramsciana permite analisar dialeticamente os limites e possibilidades instauradas pela revolução técnico-cientifico-informacional no cotidiano das relações sociais. Destaca-se, em conclusão, a importante contribuição do debate no campo da ética apresentado por Maria Lúcia Silva Barroco para a elaboração desse trabalho.

  20. Génesis y desarrollo de un movimiento armado indígena en Colombia

    Juan Manuel IBEAS DELGADO

    2009-11-01

    Full Text Available RESUMEN: El autor describe y analiza, desde la perspectiva organizacional, el ciclo de una guerrilla indígena colombiana desde su nacimiento, fruto de una gran movilización social previa, hasta su incorporación a la vida legal, resultado de un proceso de negociación que culmina con la entrega de las armas.ABSTRACT: In this article, the author focusses on a Colombian indigenous guerrilla cycle, from the organizational point of view. The author deals with the cycle of this guerrilla since its emergente, as a result of a previous social mobilization, to its incorporation to legal political life, after a negotiation process that finishes with the rending of the weapons.

  1. Educa??o ind?gena makuxi pelas ondas da FM Monte Roraima (2003-2008)

    Silva, Antonia Costa da

    2009-01-01

    A proposta da presente pesquisa foi estudar o uso do r?dio no processo de educa??o ind?gena, atrav?s de um estudo de caso. Por ser um dos meios de comunica??o de massa, que presta grandes servi?os ? sociedade atrav?s da informa??o e do entretenimento, o r?dio tem se transformado ao longo de sua exist?ncia. Com o avan?o tecnol?gico, nos dias atuais, a instala??o e a recep??o das ondas de r?dio se tornaram acess?veis em todo o mundo. Ainda com o surgimento de outros meios de comunica??o, como a...

  2. Animal cysticercosis in indigenous Brazilian villages Cisticercose animal em aldeias indígenas brasileiras

    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

  3. V773 Cas, QS Aql, AND BR Ind: ECLIPSING BINARIES AS PARTS OF MULTIPLE SYSTEMS

    Zasche, P.; Juryšek, J.; Nemravová, J.; Wolf, M.; Korčáková, D. [Astronomical Institute, Charles University in Prague, Faculty of Mathematics and Physics, CZ-180 00, Praha 8, V Holešovičkách 2 (Czech Republic); Uhlař, R. [Private Observatory, Pohoří 71, CZ-254 01, Jílové u Prahy (Czech Republic); Svoboda, P. [Private Observatory, Výpustky 5, CZ-614 00, Brno (Czech Republic); Hoňková, K. [Variable Star and Exoplanet Section of Czech Astronomical Society, Vsetínská 941/78, CZ-757 01, Valašské Meziříčí (Czech Republic); Mašek, M.; Prouza, M. [Institute of Physics, The Czech Academy of Sciences, Na Slovance 1999/2, CZ-182 21, Praha (Czech Republic); Čechura, J.; Šlechta, M., E-mail: zasche@sirrah.troja.mff.cuni.cz [Astronomical Institute, The Czech Academy of Sciences, CZ-251 65, Ondřejov (Czech Republic)

    2017-01-01

    Eclipsing binaries remain crucial objects for our understanding of the universe. In particular, those that are components of multiple systems can help us solve the problem of the formation of these systems. Analysis of the radial velocities together with the light curve produced for the first time precise physical parameters of the components of the multiple systems V773 Cas, QS Aql, and BR Ind. Their visual orbits were also analyzed, which resulted in slightly improved orbital elements. What is typical for all these systems is that their most dominant source is the third distant component. The system V773 Cas consists of two similar G1-2V stars revolving in a circular orbit and a more distant component of the A3V type. Additionally, the improved value of parallax was calculated to be 17.6 mas. Analysis of QS Aql resulted in the following: the inner eclipsing pair is composed of B6V and F1V stars, and the third component is of about the B6 spectral type. The outer orbit has high eccentricity of about 0.95, and observations near its upcoming periastron passage between the years 2038 and 2040 are of high importance. Also, the parallax of the system was derived to be about 2.89 mas, moving the star much closer to the Sun than originally assumed. The system BR Ind was found to be a quadruple star consisting of two eclipsing K dwarfs orbiting each other with a period of 1.786 days; the distant component is a single-lined spectroscopic binary with an orbital period of about 6 days. Both pairs are moving around each other on their 148 year orbit.

  4. Educacion y salud indígena: preámbulo a un futuro ciudadano.

    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.

  5. Política ambiental y territorios indígenas de Sonora

    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.

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

    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.

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

    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.

  8. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.

    Gupta, Ravi; Dhruva, Sanket S; Fox, Erin R; Ross, Joseph S

    2017-10-01

    Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. To examine the clinical evidence for approval and association with prices and shortages of previously unapproved prescription drugs after being addressed by the UDI. Previously unapproved prescription drugs that faced UDI regulatory action or with at least 1 product that received FDA approval through manufacturers' voluntary compliance with the UDI between 2006 and 2015 were identified. The clinical evidence was categorized as either newly conducted clinical trials or use of previously published literature and/or bioequivalence studies to demonstrate safety and efficacy. We determined the change in average wholesale price, presence of shortage, and duration of shortage for each drug during the 2 years before and after UDI regulatory action or approval through voluntary compliance. Between 2006 and 2015, 34 previously unapproved prescription drugs were addressed by the UDI. Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, not new clinical trial evidence. Among the 26 drugs with available pricing data, average wholesale price during the 2 years before and after voluntary approval or UDI action increased by a median of 37% (interquartile range [IQR] = 23%-204%; P Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to

  9. Exploratory behaviour, emotional wellbeing and childcare quality in preschool education

    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.

  10. SOL-IND. Photovoltaics integrated in an industrialised building process. Final report; SOL-IND. Solceller integreret i industrielt byggeri. Slutrapport

    Frederiksen, K.H.B.; Vestersager Engdal, J. (EnergiMidt A/S, Silkeborg (Denmark))

    2008-06-15

    The purpose of the project, EFP06 - Photovoltaics integrated in an industrialised building process (SOLIND), has been to examine the possibilities for PV (photovoltaics) in an industrialized building process. The project is an information gathering and development project with basis in knowledge about the possibilities for PV in relation to specific housing projects in Skanska Bolig A/S, including BoKlok, developed in cooperation with IKEA. During the project a workshop with participating architectural students has been carried through resulting in detailed concepts. The concepts have in general terms been introduced nationally to the press and were invited to a poster presentation at the world's largest PV conference. In addition to this, a number of prototypes are produced together with other presentation material. The projects has been divided into three phases. The report is divided into these three phases. 1) Knowledge gathering and unravelling 2) Analysis, development and evaluation, workshop for students. 3) Promotion and demonstration of results The main results are: 4) The project has resulted in increased knowledge about the possibilities with photovoltaics in industrialized building processes. 5) A number of concepts have been developed to fit PV in the project phase of an industrialized building process. 6) The most promising concepts has been demonstrated as prototypes in different scale together with other presentation materials The project continues in SOL-IND2, with the purpose to prepare and carry out an integration of a PV system in an industrialized building process. A subsidy is granted in 2008 from the EFP to prepare the construction. (au)

  11. 77 FR 5027 - Food and Drug Administration Transparency Initiative: Exploratory Program To Increase Access to...

    2012-02-01

    ...] Food and Drug Administration Transparency Initiative: Exploratory Program To Increase Access to the... entitled ``Food and Drug Administration Transparency Initiative: Exploratory Program to [[Page 5028

  12. Indústrias criativas: alternativa de desenvolvimento regional | Creative industries: regional development alternatives

    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

  13. 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

    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

  14. Twentieth Anniversary of Leptin discovery and the Approval of Myalept by FDA

    Ata Mahmoodpoor

    2015-04-01

    Full Text Available Leptin is a 16 kDa hormone that is mainly expressed in adipose tissues (1. The major target of leptin is hypothalamus and it suppresses food intake and energy consumption, consequently diminishing adipose deposits and body weight (2, 3. The OB gene was isolated by Friedman in 1994 (4.  Based on the suggestion of Roger Guillemin, Friedman named this new hormone "leptin" from the Greek lepto meaning thin (5, 6. Since leptin discovery, numerous studies have been conducted on its physiological effects and its function in pathological conditions. Most of studies on leptin concentrated on its metabolic actions (7, receptors (8 and further broad functions such as immunity modulation (9 and memory processing (10. Considering such a vast range of functions, it is clear that patients with lack of leptin physiologically need pharmacological interventions. At this moment, we are in the twentieth year of leptin discovery. Finally, FDA approved a drug named Myalept (metreleptin for injection on February 2014 to treat rare metabolic disease caused by leptin deficiency. Congenital generalized lipodystrophy is a disorder with partial lack of fat tissues (11. The trial for the safety and effectiveness of Myalept demonstrated decrease in HbA1c, fasting blood glucose, and triglycerides (11. Nevertheless, there are some limitations to the usage of Myalept in HIV-related lipodystrophy and some metabolic disorders (11. Moreover, it may increase the risk of lymphoma by producing anti-metreleptin antibodies neutralizing endogenous leptin. Considering these concerns, Myalept is available only through a limited profile under a Risk Evaluation and Mitigation Strategy (REMS. Myalept is contraindicated in patients with general obesity not related to congenital leptin deficiency (12. Even though, Myalept has very limited indications for use in general population, it is considered a milestone towards the discovery of novel treatments for Leptin deficiencies and disorders

  15. Mining association patterns of drug-interactions using post marketing FDA's spontaneous reporting data.

    Ibrahim, Heba; Saad, Amr; Abdo, Amany; Sharaf Eldin, A

    2016-04-01

    Pharmacovigilance (PhV) is an important clinical activity with strong implications for population health and clinical research. The main goal of PhV is the timely detection of adverse drug events (ADEs) that are novel in their clinical nature, severity and/or frequency. Drug interactions (DI) pose an important problem in the development of new drugs and post marketing PhV that contribute to 6-30% of all unexpected ADEs. Therefore, the early detection of DI is vital. Spontaneous reporting systems (SRS) have served as the core data collection system for post marketing PhV since the 1960s. The main objective of our study was to particularly identify signals of DI from SRS. In addition, we are presenting an optimized tailored mining algorithm called "hybrid Apriori". The proposed algorithm is based on an optimized and modified association rule mining (ARM) approach. A hybrid Apriori algorithm has been applied to the SRS of the United States Food and Drug Administration's (U.S. FDA) adverse events reporting system (FAERS) in order to extract significant association patterns of drug interaction-adverse event (DIAE). We have assessed the resulting DIAEs qualitatively and quantitatively using two different triage features: a three-element taxonomy and three performance metrics. These features were applied on two random samples of 100 interacting and 100 non-interacting DIAE patterns. Additionally, we have employed logistic regression (LR) statistic method to quantify the magnitude and direction of interactions in order to test for confounding by co-medication in unknown interacting DIAE patterns. Hybrid Apriori extracted 2933 interacting DIAE patterns (including 1256 serious ones) and 530 non-interacting DIAE patterns. Referring to the current knowledge using four different reliable resources of DI, the results showed that the proposed method can extract signals of serious interacting DIAEs. Various association patterns could be identified based on the relationships among

  16. Evaluation of an FDA approved library against laboratory models of human intestinal nematode infections.

    Keiser, Jennifer; Panic, Gordana; Adelfio, Roberto; Cowan, Noemi; Vargas, Mireille; Scandale, Ivan

    2016-07-01

    Treatment options for infections with soil-transmitted helminths (STH) - Ascaris lumbricoides, Trichuris trichiura and the two hookworm species, Ancylostoma duodenale and Necator americanus - are limited despite their considerable global health burden. The aim of the present study was to test the activity of an openly available FDA library against laboratory models of human intestinal nematode infections. All 1,600 drugs were first screened against Ancylostoma ceylanicum third-stage larvae (L3). Active compounds were scrutinized and toxic compounds, drugs indicated solely for topical use, and already well-studied anthelmintics were excluded. The remaining hit compounds were tested in parallel against Trichuris muris first-stage larvae (L1), Heligmosomoides polygyrus third-stage larvae (L3), and adult stages of the three species in vitro. In vivo studies were performed in the H. polygyrus and T. muris mice models. Fifty-four of the 1,600 compounds tested revealed an activity of > 60 % against A. ceylanicum L3 (hit rate of 3.4 %), following incubation at 200 μM for 72 h. Twelve compounds progressed into further screens. Adult A. ceylanicum were the least affected (1/12 compounds active at 50 μM), while eight of the 12 test compounds revealed activity against T. muris L1 (100 μM) and adults (50 μM), and H. polygyrus L3 (200 μM). Trichlorfon was the only compound active against all stages of A. ceylanicum, H. polygyrus and T. muris. In addition, trichlorfon achieved high worm burden reductions of 80.1 and 98.9 %, following a single oral dose of 200 mg/kg in the T. muris and H. polygyrus mouse model, respectively. Drug screening on the larval stages of intestinal parasitic nematodes is feasible using small libraries and important given the empty drug discovery and development pipeline for STH infections. Differences and commonalities in drug activities across the different STH species and stages were confirmed. Hits identified might serve as a

  17. Use of the FDA nozzle model to illustrate validation techniques in computational fluid dynamics (CFD) simulations.

    Hariharan, Prasanna; D'Souza, Gavin A; Horner, Marc; Morrison, Tina M; Malinauskas, Richard A; Myers, Matthew R

    2017-01-01

    A "credible" computational fluid dynamics (CFD) model has the potential to provide a meaningful evaluation of safety in medical devices. One major challenge in establishing "model credibility" is to determine the required degree of similarity between the model and experimental results for the model to be considered sufficiently validated. This study proposes a "threshold-based" validation approach that provides a well-defined acceptance criteria, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity. The validation criteria developed following the threshold approach is not only a function of Comparison Error, E (which is the difference between experiments and simulations) but also takes in to account the risk to patient safety because of E. The method is applicable for scenarios in which a safety threshold can be clearly defined (e.g., the viscous shear-stress threshold for hemolysis in blood contacting devices). The applicability of the new validation approach was tested on the FDA nozzle geometry. The context of use (COU) was to evaluate if the instantaneous viscous shear stress in the nozzle geometry at Reynolds numbers (Re) of 3500 and 6500 was below the commonly accepted threshold for hemolysis. The CFD results ("S") of velocity and viscous shear stress were compared with inter-laboratory experimental measurements ("D"). The uncertainties in the CFD and experimental results due to input parameter uncertainties were quantified following the ASME V&V 20 standard. The CFD models for both Re = 3500 and 6500 could not be sufficiently validated by performing a direct comparison between CFD and experimental results using the Student's t-test. However, following the threshold-based approach, a Student's t-test comparing |S-D| and |Threshold-S| showed that relative to the threshold, the CFD and experimental datasets for Re = 3500 were statistically similar and the model could be

  18. 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

    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

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

    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

  20. Exploratory Studies Facility Subsurface Fire Hazards Analysis

    Logan, Richard C.

    2002-01-01

    The primary objective of this Fire Hazard Analysis (FHA) is to confirm the requirements for a comprehensive fire and related hazards protection program for the Exploratory Studies Facility (ESF) are sufficient to minimize the potential for: The occurrence of a fire or related event; A fire that causes an unacceptable on-site or off-site release of hazardous or radiological material that will threaten the health and safety of employees, the public or the environment; Vital U.S. Department of Energy (DOE) programs suffering unacceptable interruptions as a result of fire and related hazards; Property losses from a fire and related events exceeding limits established by DOE; and Critical process controls and safety class systems being damaged as a result of a fire and related events

  1. Exploratory Studies Facility Subsurface Fire Hazards Analysis

    Kubicek, J. L.

    2001-01-01

    The primary objective of this Fire Hazard Analysis (FHA) is to confirm the requirements for a comprehensive fire and related hazards protection program for the Exploratory Studies Facility (ESF) are sufficient to minimize the potential for: (1) The occurrence of a fire or related event. (2) A fire that causes an unacceptable on-site or off-site release of hazardous or radiological material that will threaten the health and safety of employees, the public or the environment. (3) Vital US. Department of Energy (DOE) programs suffering unacceptable interruptions as a result of fire and related hazards. (4) Property losses from a fire and related events exceeding limits established by DOE. (5) Critical process controls and safety class systems being damaged as a result of a fire and related events

  2. Crowdsourcing for quantifying transcripts: An exploratory study.

    Azzam, Tarek; Harman, Elena

    2016-02-01

    This exploratory study attempts to demonstrate the potential utility of crowdsourcing as a supplemental technique for quantifying transcribed interviews. Crowdsourcing is the harnessing of the abilities of many people to complete a specific task or a set of tasks. In this study multiple samples of crowdsourced individuals were asked to rate and select supporting quotes from two different transcripts. The findings indicate that the different crowdsourced samples produced nearly identical ratings of the transcripts, and were able to consistently select the same supporting text from the transcripts. These findings suggest that crowdsourcing, with further development, can potentially be used as a mixed method tool to offer a supplemental perspective on transcribed interviews. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. Exploratory Shaft Facility quality assurance impact evaluation

    1987-08-01

    This report addresses the impact of the quality assurance practices used for the Exploratory Shaft Facility (ESF) design, and construction in licensing as part of the repository. Acceptance criteria used for evaluating the suitability of ESF QA practices are based on documents that had not been invoked for repository design or construction activities at the time of this evaluation. This report identifies the QA practices necessary for ESF design and construction licensability. A review and evaluation of QA practices for ESF design and construction resulted in the following conclusions. QA practices were found to be acceptable with a few exceptions. QA practices for construction activities were found to be insufficiently documented in implementing procedures to allow a full and effective evaluation for licensing purposes. Recommendations are provided for mitigating impacts to ensure compatibility of the QA practices with those considered necessary for repository licensing. 8 refs., 3 tabs

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

    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...

  5. Lenguas y participación comunitaria en la educación indígena en México

    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...

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

    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...

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

    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...

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

    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...

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

    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...

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

    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...

  11. Repositioning FDA Drugs as Potential Cruzain Inhibitors from Trypanosoma cruzi: Virtual Screening, In Vitro and In Vivo Studies

    Isidro Palos

    2017-06-01

    Full Text Available Chagas disease (CD is a neglected disease caused by the parasite Trypanosoma cruzi, which affects underdeveloped countries. The current drugs of choice are nifurtimox and benznidazole, but both have severe adverse effects and less effectivity in chronic infections; therefore, the need to discover new drugs is essential. A computer-guided drug repositioning method was applied to identify potential FDA drugs (approved and withdrawn as cruzain (Cz inhibitors and trypanocidal effects were confirmed by in vitro and in vivo studies. 3180 FDA drugs were virtually screened using a structure-based approach. From a first molecular docking analysis, a set of 33 compounds with the best binding energies were selected. Subsequent consensus affinity binding, ligand amino acid contact clustering analysis, and ranked position were used to choose four known pharmacological compounds to be tested in vitro. Mouse blood samples infected with trypomastigotes from INC-5 and NINOA strains were used to test the trypanocidal effect of four selected compounds. Among these drugs, one fibrate antilipemic (etofyllin clofibrate and three β-lactam antibiotics (piperacillin, cefoperazone, and flucloxacillin showed better trypanocidal effects (LC50 range 15.8–26.1 μg/mL in comparison with benznidazole and nifurtimox (LC50 range 33.1–46.7 μg/mL. A short-term in vivo evaluation of these compounds showed a reduction of parasitemia in infected mice (range 90–60% at 6 h, but this was low compared to benznidazole (50%. This work suggests that four known FDA drugs could be used to design and obtain new trypanocidal agents.

  12. An analysis of the warning letters issued by the FDA to pharmaceutical manufacturers regarding misleading health outcomes claims

    Chatterjee S

    2012-12-01

    Full Text Available Objective: To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA to pharmaceutical manufacturers for promotional violations.Methods: Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-of-Life (QoL, and economic claims. Clinical claims included claims regarding unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims included unsubstantiated quality of life and/or health-related quality of life claims. Economic claims included any form of claim made on behalf of the pharmaceutical companies related to cost superiority of or cost savings from the drug compared to other drugs in the market.Results: In the 6-year study period, 65 warning letters were issued by FDA, which contained 144 clinical, three QoL, and one economic claim. On an average, 11 warning letters were issued per year. Omission of risk information was the most frequently violated claim (30.6% followed by unsubstantiated efficacy claims (18.6%. Warning letters were primarily directed to manufacturers of cardiovascular (14.6%, anti-microbial (14.6%, and CNS (12.5% drugs. Majority of the claims referenced in warning letters contained promotional materials directed to physicians (57%. Conclusion: The study found that misleading clinical outcome claims formed the majority of the promotional violations, and majority of the claims were directed to physicians. Since inadequate promotion of medications may lead to irrational prescribing, the study emphasizes the importance of disseminating reliable, credible, and scientific information to patients, and more importantly, physicians to protect public health.

  13. Parallel screening of FDA-approved antineoplastic drugs for identifying sensitizers of TRAIL-induced apoptosis in cancer cells

    Taylor, David J; Parsons, Christine E; Han, Haiyong; Jayaraman, Arul; Rege, Kaushal

    2011-01-01

    Tumor Necrosis Factor-α Related Apoptosis Inducing Ligand (TRAIL) and agonistic antibodies to death receptor 4 and 5 are promising candidates for cancer therapy due to their ability to induce apoptosis selectively in a variety of human cancer cells, while demonstrating little cytotoxicity in normal cells. Although TRAIL and agonistic antibodies to DR4 and DR5 are considered safe and promising candidates in cancer therapy, many malignant cells are resistant to DR-mediated, TRAIL-induced apoptosis. In the current work, we screened a small library of fifty-five FDA and foreign-approved anti-neoplastic drugs in order to identify candidates that sensitized resistant prostate and pancreatic cancer cells to TRAIL-induced apoptosis. FDA-approved drugs were screened for their ability to sensitize TRAIL resistant prostate cancer cells to TRAIL using an MTT assay for cell viability. Analysis of variance was used to identify drugs that exhibited synergy with TRAIL. Drugs demonstrating the highest synergy were selected as leads and tested in different prostate and pancreatic cancer cell lines, and one immortalized human pancreatic epithelial cell line. Sequential and simultaneous dosing modalities were investigated and the annexin V/propidium iodide assay, in concert with fluorescence microscopy, was employed to visualize cells undergoing apoptosis. Fourteen drugs were identified as having synergy with TRAIL, including those whose TRAIL sensitization activities were previously unknown in either prostate or pancreatic cancer cells or both. Five leads were tested in additional cancer cell lines of which, doxorubicin, mitoxantrone, and mithramycin demonstrated synergy in all lines. In particular, mitoxantrone and mithramycin demonstrated significant synergy with TRAIL and led to reduction of cancer cell viability at concentrations lower than 1 μM. At these low concentrations, mitoxantrone demonstrated selectivity toward malignant cells over normal pancreatic epithelial cells

  14. Parallel screening of FDA-approved antineoplastic drugs for identifying sensitizers of TRAIL-induced apoptosis in cancer cells

    Taylor David J

    2011-11-01

    Full Text Available Abstract Background Tumor Necrosis Factor-α Related Apoptosis Inducing Ligand (TRAIL and agonistic antibodies to death receptor 4 and 5 are promising candidates for cancer therapy due to their ability to induce apoptosis selectively in a variety of human cancer cells, while demonstrating little cytotoxicity in normal cells. Although TRAIL and agonistic antibodies to DR4 and DR5 are considered safe and promising candidates in cancer therapy, many malignant cells are resistant to DR-mediated, TRAIL-induced apoptosis. In the current work, we screened a small library of fifty-five FDA and foreign-approved anti-neoplastic drugs in order to identify candidates that sensitized resistant prostate and pancreatic cancer cells to TRAIL-induced apoptosis. Methods FDA-approved drugs were screened for their ability to sensitize TRAIL resistant prostate cancer cells to TRAIL using an MTT assay for cell viability. Analysis of variance was used to identify drugs that exhibited synergy with TRAIL. Drugs demonstrating the highest synergy were selected as leads and tested in different prostate and pancreatic cancer cell lines, and one immortalized human pancreatic epithelial cell line. Sequential and simultaneous dosing modalities were investigated and the annexin V/propidium iodide assay, in concert with fluorescence microscopy, was employed to visualize cells undergoing apoptosis. Results Fourteen drugs were identified as having synergy with TRAIL, including those whose TRAIL sensitization activities were previously unknown in either prostate or pancreatic cancer cells or both. Five leads were tested in additional cancer cell lines of which, doxorubicin, mitoxantrone, and mithramycin demonstrated synergy in all lines. In particular, mitoxantrone and mithramycin demonstrated significant synergy with TRAIL and led to reduction of cancer cell viability at concentrations lower than 1 μM. At these low concentrations, mitoxantrone demonstrated selectivity toward

  15. 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.

    Lowes, Steve; Jersey, Jim; Shoup, Ronald; Garofolo, Fabio; Needham, Shane; Couerbe, Philippe; Lansing, Tim; Bhatti, Masood; Sheldon, Curtis; Hayes, Roger; Islam, Rafiq; Lin, Zhongping; Garofolo, Wei; Moussallie, Marc; Teixeira, Leonardo de Souza; Rocha, Thais; Jardieu, Paula; Truog, James; Lin, Jenny; Lundberg, Richard; Breau, Alan; Dilger, Carmen; Bouhajib, Mohammed; Levesque, Ann; Gagnon-Carignan, Sofi; Jenkins, Rand; Nicholson, Robert; Lin, Ming Hung; Karnik, Shane; DeMaio, William; Smith, Kirk; Cojocaru, Laura; Allen, Mike; Fatmi, Saadya; Sayyarpour, Farhad; Malone, Michele; Fang, Xinping

    2012-04-01

    The Global CRO Council for Bioanalysis (GCC) was formed in September 2010. Since then, the representatives of the member companies come together periodically to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry. The 4th GCC Closed Forum brought together experts from bioanalytical CROs to share and discuss recent issues in regulated bioanalysis, such as the impact of coadministered drugs on stability, some differences between European Medicines Agency and US FDA bioanalytical guidance documents and lessons learned following recent Untitled Letters. Recent 483s and agency findings, as well as issues on method carryover, were also part of the topics discussed.

  16. Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop.

    Zhang, X; Duan, J; Kesisoglou, F; Novakovic, J; Amidon, G L; Jamei, M; Lukacova, V; Eissing, T; Tsakalozou, E; Zhao, L; Lionberger, R

    2017-08-01

    On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled "Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation." The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole-body framework. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  17. FDA-CDC Antimicrobial Resistance Isolate Bank: a Publicly Available Resource To Support Research, Development, and Regulatory Requirements.

    Lutgring, Joseph D; Machado, María-José; Benahmed, Faiza H; Conville, Patricia; Shawar, Ribhi M; Patel, Jean; Brown, Allison C

    2018-02-01

    The FDA-CDC Antimicrobial Resistance Isolate Bank was created in July 2015 as a publicly available resource to combat antimicrobial resistance. It is a curated repository of bacterial isolates with an assortment of clinically important resistance mechanisms that have been phenotypically and genotypically characterized. In the first 2 years of operation, the bank offered 14 panels comprising 496 unique isolates and had filled 486 orders from 394 institutions throughout the United States. New panels are being added. Copyright © 2018 American Society for Microbiology.

  18. [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

    The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

  19. FDA (Food and Drug Administration) Compliance Program Guidance Manual (FY 88). Section 4. Medical and radiological devices

    1988-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices

  20. indCAPS: A tool for designing screening primers for CRISPR/Cas9 mutagenesis events.

    Hodgens, Charles; Nimchuk, Zachary L; Kieber, Joseph J

    2017-01-01

    Genetic manipulation of organisms using CRISPR/Cas9 technology generally produces small insertions/deletions (indels) that can be difficult to detect. Here, we describe a technique to easily and rapidly identify such indels. Sequence-identified mutations that alter a restriction enzyme recognition site can be readily distinguished from wild-type alleles using a cleaved amplified polymorphic sequence (CAPS) technique. If a restriction site is created or altered by the mutation such that only one allele contains the restriction site, a polymerase chain reaction (PCR) followed by a restriction digest can be used to distinguish the two alleles. However, in the case of most CRISPR-induced alleles, no such restriction sites are present in the target sequences. In this case, a derived CAPS (dCAPS) approach can be used in which mismatches are purposefully introduced in the oligonucleotide primers to create a restriction site in one, but not both, of the amplified templates. Web-based tools exist to aid dCAPS primer design, but when supplied sequences that include indels, the current tools often fail to suggest appropriate primers. Here, we report the development of a Python-based, species-agnostic web tool, called indCAPS, suitable for the design of PCR primers used in dCAPS assays that is compatible with indels. This tool should have wide utility for screening editing events following CRISPR/Cas9 mutagenesis as well as for identifying specific editing events in a pool of CRISPR-mediated mutagenesis events. This tool was field-tested in a CRISPR mutagenesis experiment targeting a cytokinin receptor (AHK3) in Arabidopsis thaliana. The tool suggested primers that successfully distinguished between wild-type and edited alleles of a target locus and facilitated the isolation of two novel ahk3 null alleles. Users can access indCAPS and design PCR primers to employ dCAPS to identify CRISPR/Cas9 alleles at http://indcaps.kieber.cloudapps.unc.edu/.

  1. Determinantes sociales de salud en los agricultores del resguardo indígena Zenú

    Elsy C. Puello A.

    2016-04-01

    Full Text Available Objetivo: Analizar los determinantes sociales de salud presentes entre los indígenas agricultores del Resguardo Zenú de San Andrés de Sotavento. Metodología: Estudio descriptivo de corte, con enfoque cuantitativo, participaron 64 indígenas agricultores de las comunidades Celeste Imperio y Santa Elena del Municipio de San Andrés de Sotavento en el año 2012, se seleccionaron bajo la técnica del muestreo aleatorio simple. La recolección de la información se efectuó a través de encuestas estructuradas diligenciadas mediante entrevista. Resultados: El rango de edad de la población sujeto osciló entre 18 a 70 años, existe 41% de analfabetismo absoluto, las familias son extensas con orientación endogámica, las condiciones de vida son precarias, hay ausencia de actividad recreativa y actividad física programada, 97% percibe menos de un salario mínimo mensual legal vigente producto del trabajo comunitario, 95.3% pertenece al regimen de salud subsidiado, todos carecen de afiliación a riesgos laborales y pensión, 77% admitió que tuvo algún accidente laboral en el último año, así mismo, 70% manifestó morbilidad sentida relacionada con la actividad laboral. Conclusiones: Los determinantes de carácter social que influyen negativamente en la salud identificados fueron: sociopolítico, circunstancias materiales, factores biológicos, conductuales y laborales; los cuales se reflejan en deficiencias en su calidad de vida, morbilidad sentida, accidentalidad laboral, fragilidades en el Sistema de Protección Social, altos índices de analfabetismo absoluto, pobreza y características que indiscutiblemente reafirman la relación perversa e interdependiente entre analfabetismo, pobreza y salud. Sin embargo, la cohesión social se identificó como determinante social de influencia positiva para la salud (94%.

  2. Neuropsicologia transcultural: grupo indígena guarani Cross culture neuropsychology: guarany indian group

    Vivian Maria Andrade

    2007-12-01

    Full Text Available Para investigar a influência da cultura sobre o desempenho cognitivo foram estudados processos intelectuais em indivíduos de populações etnicamente diferentes. Avaliamos 12 índios e 12 pessoas não indígenas, ambos os grupos constituídos por moradores da periferia de São Paulo, pareados de acordo com idade e nível educacional. Os seguintes testes foram utilizados: Dígitos, Blocos de Corsi, Desenho com Cubos e Nomeação de Figuras. A memória verbal imediata e tardia foi avaliada por meio de estórias relacionadas ao contexto ecológico de ambos os grupos, e a memória visual, pela apresentação e recuperação de figuras. Os resultados quantitativos não demonstraram diferenças significativas entre os grupos, porém, houve uma tendência estatística dos índios mostrarem maior domínio das tarefas visuais e motoras, e os não índios das tarefas verbais. Em conclusão, é possível que o grupo indígena use a cognição de forma mais concreta e intuitiva, em função do estilo peculiar de vida, das habilidades desenvolvidas, associado à baixa escolaridade.Intellectual processes were investigated in two different populations to study the influence of culture in cognitive performance. Twelve people of an indian population of the Guarany ethnic nation were compared to 12 people ("non-indians" paired according to age and education level, both groups residing in the periphery of the city of São Paulo. The following tests were used: Digit Span; Corsi Block-Tapping Test; Block Design and Naming Figure Test. The immediate and delayed verbal memory was assessed through a short story-task with a specific ecological context and the visual memory through animal figures retrieval. No statistical differences were observed between the two groups, but a statistic tendency was observed in the sense of the indigenous group apparently encountering more facility in visual and motors tasks and the "non-indians" in verbal tasks. The results suggest

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

    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.

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

    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…

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

    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...

  6. Statistical analysis on finger replacement schemes for RAKE receivers in the soft handover region with multiple BSs over i.n.d. fading channels

    Nam, Sung Sik; Ko, Young-Chai; Alouini, Mohamed-Slim; Choi, Seyeong

    2017-01-01

    . To supplement our previous work, we present a general comprehensive framework for the performance assessment of the proposed finger replacement schemes operating over independent but non-identically distributed (i.n.d.) faded paths. To accomplish this object, we

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

    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.

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

    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

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

    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.

  10. Educación Superior y Pueblos Indígenas en América Latina

    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.

  11. Biosíntesis de los alcaloides indólicos: Una revisión crítica

    Loyola-Vargas, Víctor M.; Sánchez-Iturbe, Patricia; Canto-Canché, Blondy; Gutiérrez-Pacheco, Luis C.; Galaz-Ávalos, Rosa M.; Moreno-Valenzuela, Oscar

    2004-01-01

    Los alcaloides son uno de los grupos de metabolitos secundarios más diversos encontrados en los organismos vivos. Este grupo incluye alrededor de 12,000 productos, entre los cuales se encuentran los alcaloides indólicos, alcaloides derivados del triptofano que conforman alrededor de la cuarta parte de todos ellos. Los alcaloides se han reportado en varias familias vegetales, pero principalmente en las Apocinacea, Loganiaceae y Rubiaceae, todas del orden Gentianales. Entre los alcaloides más i...

  12. Salud, salud mental, música y musicoterapia en una comunidad indígena colombiana. Cota, 2012-2014

    Leonardo Alfonso Morales-Hernández

    2017-07-01

    Conclusiones. La reetnización es una decisión política con implicaciones culturales, organizativas y de salud. Las comunidades reetnizadas no pueden ser equiparadas con la sociedad dominante ni con otros grupos indígenas en cuanto a decisiones en salud. La salud pública requiere un diálogo intercultural que permita el trabajo adecuado con estas comunidades.

  13. Réduction des pertes de fruits en Inde et au Sri Lanka grâce à la ...

    L'Inde et le Sri Lanka sont d'importants producteurs de légumes et de fruits tropicaux, mais ils enregistrent chaque année des pertes après récolte atteignant de 35 % à 40 % qui sont évaluées à environ 800 millions de dollars. Ces pertes se répercutent sur les moyens de subsistance de près du tiers de la population, ...

  14. Misiones y lingüística indígena a finales del siglo xix en Colombia

    Triana y Antorveza, Humberto; Internacionalista y Antropólogo, investigador de Fundación Comunidades Colombianas, FUNCOL.

    2004-01-01

    Este trabajo trata sobre la labor realizada por misioneros y comuni­dades religiosas en el Siglo XIX en el aprendizaje y estudio de las lenguas aborígenes. Enfatiza cómo a fines de éste siglo, el conoci­miento de las lenguas indígenas fue objetivo prioritario de las misiones católicas.

  15. Méga-événements en Inde, au Brésil et en Afrique du Sud: Des ...

    13 déc. 2016 ... Dans cet article de 2015, Brij Maharaj de l'Université de Kwazulu-Natal présente une perspective manquante, en examinant trois méga-événements récents dans le Sud Global: les Jeux du Commonwealth 2010 à Delhi, en Inde; La Coupe du Monde de la FIFA 2010 en Afrique du Sud; Et la Coupe du ...

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

    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.

  17. Skill Transfer and Virtual Training for IND Response Decision-Making: Game Design for Disaster Response Training

    2016-01-01

    another important class of modern games that can be leveraged for serious game purposes. That genre of game can be more appropriate than a strategy...with films and books, such as emotional engagement, cultural relevance, and societal impact [21]. 9 2.3 LIGHTWEIGHT GAMES Another core concept...explosives EM emergency manager IND improvised nuclear device Narrative Game A genre of game focused on immersive story telling Playtester A

  18. Pauvreté, inégalités et violence en milieu urbain en Inde : vers un ...

    Le présent projet permettra de déterminer de quelle manière la planification et la gouvernance urbaines inclusives peuvent contribuer à réduire les tensions, les conflits, les inégalités et la violence dans cinq villes de l'Inde (Ahmedabad, Gurgaon, Patna, Guwahati et Bidar). Il s'intéressera aux moyens que prennent les ...

  19. CADDIS Volume 4. Data Analysis: Exploratory Data Analysis

    Intro to exploratory data analysis. Overview of variable distributions, scatter plots, correlation analysis, GIS datasets. Use of conditional probability to examine stressor levels and impairment. Exploring correlations among multiple stressors.

  20. Research Paper An exploratory study of psychological and ...

    Research Paper An exploratory study of psychological and developmental issues facing HIV and AIDS affected adolescents living in a residential care facility. Myrthe Van Vilsteren, Sadiyya Haffejee, Rabia Patel, Brett Bowman ...