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Sample records for english drugs industry

  1. Manufacturing Industry Employers’ Perception of Graduates’ English Language Skills Proficiency

    Directory of Open Access Journals (Sweden)

    Manjet Kaur Mehar Singh

    2012-09-01

    Full Text Available Proficiency in English language skills among graduates that create advantages for the organization is preferred by prospective employers as one of the main criteria for employability.  This article provides an overview of undergraduates in higher education and also workplace literacy from the perspective of the employers in the manufacturing industry. The result from the research demonstrates that Malaysian manufacturing industry employers perceive that the graduate employees’ English language proficiency skills are still below their expectations. Therefore, this study recommends that there is a need for intervention into language teaching to improve the English language syllabus level of English proficiency at primary, secondary and tertiary level. At the same time, emphasis on the importance of English in everyday use should be inculcated without neglecting the national language of Malaysia.  This will ensure that the teaching of English will be in line with globalization and current workplace demands.

  2. Energy and the English Industrial Revolution.

    Science.gov (United States)

    Wrigley, E A

    2013-03-13

    Societies before the Industrial Revolution were dependent on the annual cycle of plant photosynthesis for both heat and mechanical energy. The quantity of energy available each year was therefore limited, and economic growth was necessarily constrained. In the Industrial Revolution, energy usage increased massively and output rose accordingly. The energy source continued to be plant photosynthesis, but accumulated over a geological age in the form of coal. This poses a problem for the future. Fossil fuels are a depleting stock, whereas in pre-industrial time the energy source, though limited, was renewed each year.

  3. New Zealand’s Drug Development Industry

    Directory of Open Access Journals (Sweden)

    Christopher Carswell

    2013-09-01

    Full Text Available The pharmaceutical industry’s profitability depends on identifying and successfully developing new drug candidates while trying to contain the increasing costs of drug development. It is actively searching for new sources of innovative compounds and for mechanisms to reduce the enormous costs of developing new drug candidates. There is an opportunity for academia to further develop as a source of drug discovery. The rising levels of industry outsourcing also provide prospects for organisations that can reduce the costs of drug development. We explored the potential returns to New Zealand (NZ from its drug discovery expertise by assuming a drug development candidate is out-licensed without clinical data and has anticipated peak global sales of $350 million. We also estimated the revenue from NZ’s clinical research industry based on a standard per participant payment to study sites and the number of industry-sponsored clinical trials approved each year. Our analyses found that NZ’s clinical research industry has generated increasing foreign revenue and appropriate policy support could ensure that this continues to grow. In addition the probability-based revenue from the out-licensing of a drug development candidate could be important for NZ if provided with appropriate policy and financial support.

  4. Drug needs of the sheep industry.

    Science.gov (United States)

    Bulgin, M S

    1993-01-01

    Two areas of drug needs in the sheep industry are reviewed. The first is the need for prolificacy drugs such as those used outside the country. These drugs would encourage out-of-season lambing, increased lambs/per ewe during the traditional lambing season and synchronize estrus for easier management of lambing and increased use of artificial insemination for faster genetic improvement. The other area is drugs to treat or prevent major causes of disease, specifically abortion, neonatal diarrhea, pneumonia and internal parasitism. Efficacious drugs for these diseases are either not now cleared for use in sheep at all; a safe, easy to administer product is not available; or not cleared for sheep at a dosage level which is effective. These are drugs which will have a positive impact on the industry by increasing production, reducing expenses, and helping the U. S. to be able to compete with other sheep producing countries in the U. S. markets.

  5. Nuclear English: Language skills for a globalizing industry

    International Nuclear Information System (INIS)

    Gorlin, S.

    2005-01-01

    Nuclear English is a new course designed for English language learners working in the nuclear industry and in other fields of nuclear science and technology. The textbook is composed of 12 units, each covering a different aspect of the nuclear fuel cycle or a relevant topic such as non-proliferation, safety and the use of radioisotopes in medicine. Nuclear English offers a flexible approach, allowing learners to: Study the units in any order according to professional need or interest; Focus on listening, grammar and pronunciation tasks, which are clearly signposted; Work independently or with other students in a classroom. The other main features of the course are: A audio CD containing authentic interviews with industry specialists. The course covers various accents, including British, American, Australian, South African and Indian; Transcripts of the listening materials; A language orientation test, which learners can take at the start of the course to identify their grammar weaknesses; Teacher-led exercises for working in pairs or groups; A glossary of key terms; An answer key; a downloadable teacher's guide to help teachers maximize the learning potential of the materials (available at: www.world-nuclear-university.org)

  6. Exotic drugs and English medicine: England’s drug trade, c.1550-c.1800

    OpenAIRE

    Patrick Wallis

    2010-01-01

    What effect did the dramatic expansion in long distance trade in the early modern period have on healthcare in England? This paper presents new evidence on the scale, origins and content of English imports of medical drugs between 1567 and 1774. It shows that the volume of medical drugs imported exploded in the seventeenth century, and continued growing more gradually over the eighteenth century. The variety of drugs imported changed more slowly. Much was re-exported, but estimates of dosages...

  7. The Academic English Language Needs of Industrial Design Students in UiTM Kedah, Malaysia

    Science.gov (United States)

    Adzmi, Nor Aslah; Bidin, Samsiah; Ibrahim, Syazliyati; Jusoff, Kamaruzaman

    2009-01-01

    The purpose of this study was to analyse the academic English language lacks and needs of Industrial Design students in Universiti Teknologi MARA Kedah (UiTM). It highlights the lacks and needs for English for Academic Purposes in helping the students to succeed in the program through the usage of English language. The research tools used were in…

  8. Growth in an English population from the Industrial Revolution.

    Science.gov (United States)

    Mays, S; Brickley, M; Ives, R

    2008-05-01

    The rapid urbanization of the Industrial Revolution in 18th-19th century England presented new health challenges. Our aim is to investigate using English skeletal remains whether the living conditions for an urban working class group in the Industrial Revolution negatively impacted upon their skeletal growth compared with a population from a rural agrarian parish. The Industrial Revolution skeletal material is from St Martin's Churchyard, Birmingham (SMB), West Midlands. It dates primarily from the first half of the nineteenth century when Birmingham was a major manufacturing center. The rural group is from Wharram Percy (WP), North Yorkshire, and dates from 10th-19th century AD. The methodology involves plotting diaphyseal bone lengths versus dental age for subadults. No overall difference was found between the two populations in bone length-for-age among the 2- to 18-year cohort. However the younger parts of the SMB cohort were smaller than at WP; the opposite was true of the older parts of the cohort. Growth rate, as inferred from crosssectional data, appeared greater at SMB than at WP. The only result consistent with expectations is the larger bone dimensions in young children from WP, but this likely reflects prolonged breastfeeding at WP not differences in urban and rural environments. That the deleterious health effects that we know accompanied the major transition in human society from a rural agrarian to an urban industrialized living environment should be little manifest in skeletal endochondral growth data is discouraging for those who would use such methodology to monitor health in earlier populations. (c) 2008 Wiley-Liss, Inc.

  9. Drug policy constellations: A Habermasian approach for understanding English drug policy.

    Science.gov (United States)

    Stevens, Alex; Zampini, Giulia Federica

    2018-04-24

    It is increasingly accepted that a view of policy as a rational process of fitting evidence-based means to rationally justified ends is inadequate for understanding the actual processes of drug policy making. We aim to provide a better description and explanation of recent English drug policy decisions. We develop the policy constellation concept from the work of Habermas, in dialogue with data from two contemporary debates in English policy; on decriminalisation of drug possession and on recovery in drug treatment. We collect data on these debates through long-term participant observation, stakeholder interviews (n = 15) and documentary analysis. We show the importance of social asymmetries in power in enabling structurally advantaged groups to achieve the institutionalisation of their moral preferences as well as the reproduction of their social and economic power through the deployment of policies that reflect their material interests and normative beliefs. The most influential actors in English drug policy come together in a 'medico-penal constellation', in which the aims and practices of public health and social control overlap. Formal decriminalisation of possession has not occurred, despite the efforts of members of a challenging constellation which supports it. Recovery was put forward as the aim of drug treatment by members of a more powerfully connected constellation. It has been absorbed into the practice of 'recovery-oriented' drug treatment in a way that maintains the power of public health professionals to determine the form of treatment. Actors who share interests and norms come together in policy constellations. Strategic action within and between constellations creates policies that may not take the form that was intended by any individual actor. These policies do not result from purely rational deliberation, but are produced through 'systematically distorted communication'. They enable the most structurally favoured actors to institutionalise

  10. Partnerships and communities in English drug policy: the challenge of deprivation.

    Science.gov (United States)

    Macgregor, Susanne; Thickett, Anthony

    2011-11-01

    From the mid-1990s, UK governments developed partnerships to tackle drugs nationally and locally. Over time, increased resources focused on communities and localities in greatest need. This reflected growing awareness of the concentration of problems in deprived areas, with social and spatial segregation being a feature of post-industrial urban areas. A review of English drug policy since the 1990s, drawing on:- analysis of documents; a review of sociological studies; an illustrative case-study of one northern town; interviews with local policy players; statistical analysis of key indicators with some of these data presented using Geographical Information System (GIS) mapping. In-depth sociological studies demonstrate interconnections between historical patterns, socio-economic change, cultural complexity, deprivation, limited opportunities and illicit drugs. At local level, there are links between concentrated multiple deprivation, poor health, acquisitive crime and problematic drug use. Partnership policies, encouraged by the provision of ring-fenced funds, have been effective in containing problems. Underlying issues of inequality are however neglected in political debates. The article argues that post-industrial towns and cities are characterised by an increase in problems related to poverty and drugs. Both the real shape and perceptions of what is the problem change over time. In England, the profile of the problem drug user was described in a number of sociological studies conducted from the 1980s onwards. Key features were the concentration of problems in certain social groups (such as the poorly educated or unemployed) and in certain areas (inner cities or outer estates). Responding to rising public concern, national drug strategies developed and the New Labour Government after 1997 prioritised the issue of drugs, directing increased resources to drug treatment with tight control over the use of these new monies through target setting and measurement of

  11. English for Specific Purposes: A Case Study in an Industrial Setting.

    Science.gov (United States)

    Alexander, Clare

    A course outline and sample materials for a course in English for garment workshop employees in New York are presented, and theoretical considerations in establishing an English for specific purposes (ESP) course are explored. Attention is directed to the needs analysis process undertaken in the garment industry. Specifically, ESP is used to mean…

  12. Drugonomics : Industrial Organization of Illegal Drug Markets

    OpenAIRE

    Naranjo R., Alberto J.

    2007-01-01

    Insurgents, drug lords and anti-drug supply policies in the Andes. The United States has spent enormous resources on supply policies to decrease illegal drug production in the Andes and availability in the U.S. market. However, evidence suggests increased drug production and availability over time. Moreover, insurgent activities in the region have also increased. We present an explanation for these unexpected trends by analyzing an illicit drug market where drug lords and insurgents interact...

  13. An assessment of drug testing within the construction industry.

    Science.gov (United States)

    Gerber, Jonathan K; Yacoubian, George S

    2002-01-01

    Drug testing in the workplace has gone from virtual nonexistence to widespread employer acceptance during the past two decades. This growth is particularly significant for the construction industry. High rates of alcohol and other drug use, coupled with the high-risk, safety-sensitive nature of the industry, have prompted the development of a variety of drug surveillance and prevention strategies. Despite this growing vigilance, no scholarly works have examined the impact of drug-related policies in the construction industry. To address this limitation, we investigate the efficacy of workplace drug-testing programs in reducing injury incident rates and workers' compensation experience-rating modification factors (MODs) within the construction industry. Analyses indicate that companies with drug-testing programs experienced a 51 percent reduction in incident rates within two years of implementation. Moreover, companies that drug test their employees experienced a significant reduction in their MODs. Policy implications are discussed in light of the current findings.

  14. 76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Science.gov (United States)

    2011-08-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0246] Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

  15. 76 FR 6477 - Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public...

    Science.gov (United States)

    2011-02-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...

  16. Impact of industrial nuclear releases into the English Channel

    International Nuclear Information System (INIS)

    Germain, P.; Guegueniat, P.

    1992-01-01

    The nuclear fuel reprocessing plant at La Hague is the main source of releases of weakly radioactive waste into the English Channel; there are also some contributions from nuclear power stations along the coast. Indicator species, seawater samples and sediments are used to study the distribution and transfer mechanisms of radionuclides in Channel waters. The observed pattern of radiolabelled zones is in good agreement with an hydrodynamic model for the Channel. The variations of activity with time are discussed in relation to releases from La Hague

  17. How Snuck Sneaked into English and Drug is still Dragging Behind

    DEFF Research Database (Denmark)

    Horslund, Camilla Søballe

    2014-01-01

    is increasing in relative use. Drug, on the other hand, stays a minority form over time, and there is no evidence that the form is becoming common. Snuck is generally much more common than drug, in both British and American English. Furthermore, both strong past tense forms are more common in American English...... than in British English. With respect to register, the strong form is most common in the spoken register for both American and British English and least common in the academic and newspaper registers, which could be taken to support an association between language use and language attitudes, (as......Language observers may have noticed the existence of two past tense forms for the verb to sneak in American English, sneaked and snuck. Interestingly, both forms have not always coexisted; the original form is sneaked, and snuck has only recently become a real competitor for sneaked (Hogg, 1988: 31...

  18. Software systems for energy control in the English industry

    International Nuclear Information System (INIS)

    Bouma, J.W.J.

    1993-01-01

    Monitoring and targeting software systems have proved to be valuable tools for energy control, permitting to save five to ten percent of energy. The article reviews the systems that are presently available in England and illustrates how these systems are successfully used in practice in small (British Telecom) and middle large (Charles Wells Brewery) industrial applications. (A.S.)

  19. The Influence of English Communication Ability on Income in Tourist Industry Frontline Employees of Siem Reap, Cambodia

    OpenAIRE

    Jeffrey Stewart Morrow

    2017-01-01

    Siem Reap, Cambodia’s tourism growth has been remarkable. Since most tourists are native English speakers, tourist industry (TI) employees need high levels of English communication ability (ECA) to handle tasks effectively, but data in Cambodia has been difficult to find. To fill this gap, the author wanted to collect employees’ general and English education information during interviews in six TI related businesses, to assess their ECA, and to statistically examine interactions of English va...

  20. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ...] Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted... guidance for industry entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted... draft guidance for industry entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

  1. Disclosure of industry payments to prescribers: industry payments might be a factor impacting generic drug prescribing.

    Science.gov (United States)

    Qian, Jingjing; Hansen, Richard A; Surry, Daniel; Howard, Jennifer; Kiptanui, Zippora; Harris, Ilene

    2017-07-01

    Pharmaceutical companies paid at least $3.91bn to prescribers in 2013, yet evidence indicating whether industry payments shift prescribing away from generics is limited. This study examined the association between amount of industry payments to prescribers and generic drug prescribing rates among Medicare Part D prescribers. A cross-sectional analysis was conducted among 770 095 Medicare Part D prescribers after linking the 2013 national Open Payments data with 2013 Medicare Provider Utilization and Payment data. The exposure variable was the categorized amount of total industry payments to prescribers (i.e., meals, travel, research, and ownership). The outcome was prescriber's annual generic drug prescribing rate. Multivariable generalized linear regression models were used to examine the association between the amount of industry payments and prescriber's annual generic drug prescribing rates, controlling for prescriber's demographic and practice characteristics. In this sample, over one-third (38.0%) of Medicare Part D prescribers received industry payments in 2013. The mean annual generic drug prescribing rate was highest among prescribers receiving no payments and lowest among those receiving more than $500 of industry payments (77.5% vs. 71.3%, respectively; p industry payments was independently associated with prescribers' generic drug prescribing rate; higher payments corresponded with lower generic drug prescribing rates. Other prescriber characteristics associated with higher annual generic drug prescribing rate included male sex, non-northeast region, specialty, and patient volume. Receipt of industry payments was associated with a decreased rate of generic drug prescribing. How this affects patient care and total medical costs warrants further study. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  2. English

    African Journals Online (AJOL)

    Owner

    To a dubious critical salvation: Etienne Leroux and the canons of South African English criticism. This article presents a case study in cross-cultural literary reception following the act of literary translation—in this instance, of author Etienne Leroux—from Afrikaans into English. It describes the literary reception of Leroux in ...

  3. English

    DEFF Research Database (Denmark)

    Phillipson, Robert

    2011-01-01

    The article exemplifies and presents the characteristics of linguistic imperialism, linguistic capital accumulation following the same pattern as capitalist economic dominance. The text summarizes the way English was established in the colonial period. Many of the mechanisms of linguistic hierarc...... of the English iceberg....

  4. Homochiral drugs: a demanding tendency of the pharmaceutical industry.

    Science.gov (United States)

    Núñez, María C; García-Rubiño, M Eugenia; Conejo-García, Ana; Cruz-López, Olga; Kimatrai, María; Gallo, Miguel A; Espinosa, Antonio; Campos, Joaquín M

    2009-01-01

    The issue of drug chirality is now a major theme in the design and development of new drugs, underpinned by a new understanding of the role of molecular recognition in many pharmacologically relevant events. In general, three methods are utilized for the production of a chiral drug: the chiral pool, separation of racemates, and asymmetric synthesis. Although the use of chiral drugs predates modern medicine, only since the 1980's has there been a significant increase in the development of chiral pharmaceutical drugs. An important commercial reason is that as patents on racemic drugs expire, pharmaceutical companies have the opportunity to extend patent coverage through development of the chiral switch enantiomers with desired bioactivity. Stimulated by the new policy statements issued by the regulatory agencies, the pharmaceutical industry has systematically begun to develop chiral drugs in enantiometrically enriched pure forms. This new trend has caused a tremendous change in the industrial small- and large-scale production to enantiomerically pure drugs, leading to the revisiting and updating of old technologies, and to the development of new methodologies of their large-scale preparation (as the use of stereoselective syntheses and biocatalyzed reactions). The final decision whether a given chiral drug will be marketed in an enantiomerically pure form, or as a racemic mixture of both enantiomers, will be made weighing all the medical, financial and social proficiencies of one or other form. The kinetic, pharmacological and toxicological properties of individual enantiomers need to be characterized, independently of a final decision.

  5. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Science.gov (United States)

    2010-04-29

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic... and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and...

  6. The Influence of English Communication Ability on Income in Tourist Industry Frontline Employees of Siem Reap, Cambodia

    Directory of Open Access Journals (Sweden)

    Jeffrey Stewart Morrow

    2017-06-01

    Full Text Available Siem Reap, Cambodia’s tourism growth has been remarkable. Since most tourists are native English speakers, tourist industry (TI employees need high levels of English communication ability (ECA to handle tasks effectively, but data in Cambodia has been difficult to find. To fill this gap, the author wanted to collect employees’ general and English education information during interviews in six TI related businesses, to assess their ECA, and to statistically examine interactions of English variables with income. The author created an English assessment test loosely based on the Common European Framework of Reference for Languages (CEFR. Statistical analysis found direct positive influence from English ability on income. Findings also showed that employees who have advanced levels of English ability earn USD200 per month, double the salary of garment workers. This type of research can be used profitably over the Internet in many research situations.

  7. English

    DEFF Research Database (Denmark)

    Phillipson, Robert

    2011-01-01

    The article exemplifies and presents the characteristics of linguistic imperialism, linguistic capital accumulation following the same pattern as capitalist economic dominance. The text summarizes the way English was established in the colonial period. Many of the mechanisms of linguistic hierarchy...... to the present-day world ‘order’, as the postcolonial is subsumed under global empire, assisted by English linguistic neoimperialism. Some scholars who deny the existence of linguistic imperialism are reported on, and the complexity of language policy in European integration is demonstrated. The article...

  8. Removal of the nonconformities in the drug boxes packaging industry

    Directory of Open Access Journals (Sweden)

    Bălan Emilia

    2017-01-01

    Full Text Available The paper presents the specific quality aspects of cardboard drug boxes (folding boxes used as packaging in pharmaceutical industry. The types of defects and nonconformities that occur during offset printing and finishing of the packaging products are being identified and analyzed, such as: differences in color printing, scratches on the printed sheets, cracks during creasing, unparalleled gluing in respect to the closing flaps, ungluing, successive drug boxes stick to each other. The paper also focuses on aspects regarding the nonconformities removal of the drug boxes by establishing a control plan and preventive and corrective methods applicable in different technological stages of the production flow. Monitoring and analyzing activities for quality improvement of the drug boxes, in accordance with the quality specifications required by customers were performed for 20 months on a production line with Heidelberg machines. Nonconformities considered in this paper are also encountered in advertising printing.

  9. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Science.gov (United States)

    2012-04-06

    ...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...

  10. Herbal drug regulation and commercialization: an Indian industry perspective.

    Science.gov (United States)

    Sahoo, Niharika; Manchikanti, Padmavati

    2013-12-01

    To assess the constraints for Indian herbal drug industry with respect to manufacturing and commercialization of herbal medicines. A questionnaire-based survey was conducted to obtain primary data on challenges faced during production, commercialization, and marketing approval for traditional or herbal drugs in India and abroad. Responses were collected from 150 companies by email, telephone, and in-person interviews from June 2009 to August 2010 and were analyzed to draw appropriate conclusions. The survey result showed that differing regulatory requirements and the limited market in foreign countries are the major hindrances for exporting. Standardization and quality control of raw materials and herbal formulations emerged as the major challenge for Indian herbal drug manufacturing firms. Insufficient regulatory guidelines, particularly guidelines for good manufacturing practices; nonimplementation of good agricultural and collection practices; and weak implementation of the Drugs and Cosmetics Act of 1940 are considered major drawbacks for the Indian herbal industry. Proper implementation of the Drugs and Cosmetics Act of 1940, development of more elaborate guidelines on quality control aspects, and development of marker-based standards are needed to produce safe and effective herbal medicines in India. Because evidence-based studies are becoming increasingly essential for establishing the safety and efficacy of herbal products in the domestic and export market, more focus should be placed on scientific and technological advancement in the field of herbal medicine. Regulatory harmonization becomes essential to mitigate the delays in commercialization across countries.

  11. Industrial natural product chemistry for drug discovery and development.

    Science.gov (United States)

    Bauer, Armin; Brönstrup, Mark

    2014-01-01

    Covering: up to March 2013. In addition to their prominent role in basic biological and chemical research, natural products are a rich source of commercial products for the pharmaceutical and other industries. Industrial natural product chemistry is of fundamental importance for successful product development, as the vast majority (ca. 80%) of commercial drugs derived from natural products require synthetic efforts, either to enable economical access to bulk material, and/or to optimize drug properties through structural modifications. This review aims to illustrate issues on the pathway from lead to product, and how they have been successfully addressed by modern natural product chemistry. It is focused on natural products of current relevance that are, or are intended to be, used as pharmaceuticals.

  12. Redactions in protocols for drug trials: what industry sponsors concealed.

    Science.gov (United States)

    Marquardsen, Mikkel; Ogden, Michelle; Gøtzsche, Peter C

    2018-01-01

    Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.

  13. Industry Perspectives on Market Access of Innovative Drugs: The Relevance for Oncology Drugs.

    Science.gov (United States)

    Pauwels, Kim; Huys, Isabelle; Casteels, Minne; Simoens, Steven

    2016-01-01

    Key Points - Representatives of the pharmaceutical industry call for a broader recognition of value within the assessment and appraisal of innovative drugs- Focus on value within the assessment and appraisal of drugs is jeopardized by financial drives as the side of industry and at the side of the payers- A well-considered value-framework, with attention for patient reported outcomes, societal preferences and dynamic approach on the drug life cycle, needs to be incorporated in assessment and appraisal at national and European level in order to coordinate the views of different stakeholders and allow efficient resource allocation This study presents industry perspectives on the challenges related to market access of innovative drugs in general and oncology drugs in specific. Fifteen interviews were conducted with representatives of pharmaceutical companies and industry associations. Interviewees call for a broader recognition of value within the assessment and appraisal of drugs. According to interviewees, focus on value is jeopardized by the lack of a common value definition across Europe, poor availability and validity of value measures and cost-saving measures such as external reference price setting and cost-effectiveness analysis at the side of the payers. Centralized assessment of relative-effectiveness at European level would provide a common value estimate across member states, independent of financial drivers. Empirical evidence on PRO and societal preferences is however essential in the development of a value definition. Furthermore, value-based pricing would imply a dynamic approach where the price is differentiated across indications and across the lifecycle of the drug, especially in fields such as oncology. Financial drivers however also threat the application of value-based pricing at the side of the industry, making value-based profitability a more appropriate term.

  14. 75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Science.gov (United States)

    2010-08-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0246] Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  15. Practical English Education for Natural Science and Technology through the Academic-Industrial Cooperation in Gunma University

    Science.gov (United States)

    Shinozuka, Kazuo

    English education for specific purpose (ESP) , particularly for the field of natural sciences and technologies, has been attracting great interests in Japan because of the growing demands of the ability to use English in working place to the graduates in the filed. In Gunma University, we have launched a new style of ESP program tilted as “Collaboration between Academic and Industrial Sectors for Practical English Education” as a part of Good Practice Program supported by the Ministry of Education, Culture, Sports, Science, and Technology, Japan (MEXT) since 2006. The program aims to steam up the ability of students to use English through a variety of activities including the presentation of scientific topics in English in a regular class work and the pseudo-conversation (role-playing) style training in a non-regular class work.

  16. Recombinant drug development, regulation, and commercialization: an Indian industry perspective.

    Science.gov (United States)

    Sahoo, Niharika; Manchikanti, Padmavati

    2011-04-01

    The Indian biopharmaceutical sector comprises nearly 40 companies that manufacture and/or market 14 recombinant drugs that account for nearly 50 products. Among these, 22 companies have manufacturing facilities in India. The aim of the present study was to analyze the patenting trends, commercialization, and regulatory system for biopharmaceuticals in India. Representatives from 19 such biopharmaceutical companies were interviewed on aspects related to regulatory compliance, manufacturing, commercialization, and innovation in order to understand the challenges faced by them in the current regulatory and patent system. The study revealed that 94% of the companies have filed patents and 52% are developing new biologic entities in areas such as diabetes mellitus, cancer, and congestive heart diseases. Forty-two percent of the companies consider delays in regulatory approval to be a major constraint for biopharmaceutical industry development. Almost all are of the opinion that uniform guidelines across countries would help to prevent delays in the commercialization of products. A high proportion of representatives of the biopharmaceutical industry in India identified that elaboration of regulatory guidelines, defined submission requirements, and drug approval timelines are vital to the growth of the biopharmaceutical industry. © 2011 Adis Data Information BV. All rights reserved.

  17. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Science.gov (United States)

    2010-11-29

    ...] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY... announcing the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration... single copies of the guidance document entitled ``Guidance for Industry and Food and Drug Administration...

  18. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-01-05

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance... single copies of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug... available at http://www.regulations.gov . To receive ``Draft Guidance for Industry and Food and Drug...

  19. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Science.gov (United States)

    2013-02-19

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...

  20. Tobacco, alcohol and drug use among dental undergraduates at one English university in 1998 and 2008.

    Science.gov (United States)

    Underwood, B; Fox, K; Manogue, M

    2010-02-27

    To estimate the prevalence of tobacco, alcohol and drug use among dental undergraduates at one English university in 2008, and compare these with prevalence in 1998. Cross-sectional survey using an anonymous self-report questionnaire. In 2008 all 384 dental undergraduates at one English university were sent a questionnaire in order to obtain data on the frequency and amount of tobacco, alcohol, cannabis and other illicit drugs used before and during their time as a dental undergraduate. The same survey had been conducted on dental undergraduates at the university 10 years earlier. Tobacco smoking was reported by 27% of males and 13.5% of females, a reduction from 1998 (42% of males and 32% of females) being significant among females. 63% of males and 69.5% of females reported drinking alcohol: significantly fewer than in 1998 (82% males and 90% females). Binge drinking was reported by 69.5% of males compared to 56% in 1998. In females 66% binged compared to 58.5% in 1998. The increase in males was significant. 62% of males and 68% of females had never used cannabis compared to 38% in males and 50.5% of females in 1998, a significant reduction. A significant reduction in amphetamine use was reported among both male and female undergraduates in 2008 compared to 1998 and a significant increase in amyl nitrate use was reported by females. Reported illicit drug use was associated with alcohol drinking, and particularly with tobacco use. Dental undergraduates at one English university in 2008 when compared to those in 1998 are reported to be significantly less likely to drink alcohol, use cannabis and amphetamines. If female, they are significantly less likely to smoke tobacco and overestimate the number of units of alcohol they can safely consume in a week, but more likely to use amyl nitrate. If male, those who drink alcohol are significantly less likely to drink at a level of increased risk, but more likely to binge drink.

  1. The Commissioning and Provision of Advocacy for Problem Drug Users in English DATS: A Cross-Sectional Survey

    Science.gov (United States)

    Cargill, Tamsin; Weaver, Tim D.; Patterson, Sue

    2012-01-01

    Aims: This study investigated the commissioning and delivery of advocacy for problem drug users. We aimed to quantify provision, describe the commissioning of advocacy services in Drug Action Teams (DATs) and to identify factors influencing advocacy provision. Methods: A cross-sectional survey of a randomly selected sample of 50 English DATs. The…

  2. Grammatical Adaptation of English Loanwords of Gaming Industry in the Russian Language

    Directory of Open Access Journals (Sweden)

    Semen V. Gornostaev

    2017-03-01

    Full Text Available The article is devoted to the grammatical adaptation of borrowed from the English lexems in the sphere of the interactive entertainment industry. It has been given also other processes of development of language units of the thematic groups: phonetic, lexical, semantic. Nominations were taken by continuous sampling of periodicals (magazine «Gambling», various Internet sources and lively conversation, presented on Internet forums. The subject of the analysis is one-component substantive derivative and nonderivative nomination. During the study the following results were obtained. 1. The leading features of grammatical adaptation of anglicisms in the sphere of the gaming industry are: a the appearance of declinability, stabilization of generic relatedness (not only animated, but also inanimate nouns, b expansion of the capacity of the diversion, which is manifested in the formation of word-forming nest of three types - nest-pairs, nest-bundles and nest-chains. 2. Derivative words included in their composition, may belong to different parts of speech (nouns and verbs and formed by affix (suffixes and prefixing and non-affix (abbriviation, clipping, adding ways. 3. There are units in the language-recipient that have not undergone the process of grammatical adaptation: blotches and immutable acronyms.

  3. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Science.gov (United States)

    2012-02-23

    ...] Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal... industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug...). This updated draft guidance is intended to provide individuals in the human and animal food industries...

  4. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-11-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of...

  5. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-10-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

  6. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Science.gov (United States)

    2013-01-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...

  7. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Science.gov (United States)

    2011-07-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0530] Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  8. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-04-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0916] Medical Device Classification Product Codes; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  9. 76 FR 6685 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommended Warning for...

    Science.gov (United States)

    2011-02-07

    ... as a cause of respiratory allergic reactions; (2) rhinitis, conjunctivitis, and dyspnea; (3... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  10. Industry Perspective of Drug Development for Pregnant/Breastfeeding Women.

    Science.gov (United States)

    Korth-Bradley, J M

    2016-07-01

    As part of drug development, drug companies conduct experiments to gather data about the potential toxicity of medications in pregnant and lactating animals. Increasingly, physiologically based pharmacokinetic models are developed to simulate drug concentrations in pregnant and lactating women. As these women are not usually included in clinical trials, targeted postapproval safety monitoring, registries, or clinical studies may be performed to gather safety and efficacy information about drug use in these special populations. © 2016 ASCPT.

  11. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  12. 78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

    Science.gov (United States)

    2013-03-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  13. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Science.gov (United States)

    2011-01-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0635] Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  14. 75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

    Science.gov (United States)

    2010-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0076] (formerly Docket No. 2007D-0387) Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies--Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS...

  15. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-07-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug...

  16. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Science.gov (United States)

    2011-11-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  17. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Science.gov (United States)

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...

  18. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  19. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Science.gov (United States)

    2012-12-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1161] Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  20. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Science.gov (United States)

    2012-01-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0916] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. [[Page 126...

  1. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Science.gov (United States)

    2011-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  2. 77 FR 60126 - Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2012-10-02

    ...; Formerly 2008N-0004] Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment... Media: Developing Drugs for Treatment.'' This guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for the...

  3. 77 FR 11133 - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for...

    Science.gov (United States)

    2012-02-24

    ...] Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for Treatment... Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (c...

  4. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Science.gov (United States)

    2013-12-04

    ...] Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing... Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The draft... human drug compounders that choose to register as outsourcing facilities (outsourcing facilities). DATES...

  5. 78 FR 27115 - Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use...

    Science.gov (United States)

    2013-05-09

    ... Use--Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of... guidance for industry entitled ``Expanded Access to Investigational Drugs for Treatment Use--Qs & As... drugs for treatment use. FDA has received a number of questions about implementation of its expanded...

  6. 75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

    Science.gov (United States)

    2010-08-02

    ... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0125] Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an...

  7. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Science.gov (United States)

    2012-02-21

    ...] (Formerly Docket No. 2006D-0344) Draft Guidance for Industry on Drug Interaction Studies--Study Design, Data... availability of a revised draft guidance for industry entitled ``Drug Interaction Studies--Study Design, Data... transport, and drug-drug, or drug-therapeutic protein interactions. DATES: Although you can comment on any...

  8. Web Based Projects Enhancing English Language and Generic Skills Development for Asian Hospitality Industry Students

    Science.gov (United States)

    Wang, Mei-jung

    2009-01-01

    This study investigated hospitality students' responses toward their learning experiences from undertaking group projects based upon a College web platform, the "Ubiquitous Hospitality English Learning Platform" (U-HELP). Twenty-six students in the Department of Applied Foreign Languages participated in this study. Their attitudes toward…

  9. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Science.gov (United States)

    2010-04-29

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for... the Internet. To receive ``Draft Guidance for Industry and Food and Drug Administration Staff; User... and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and...

  10. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Science.gov (United States)

    2010-12-03

    ... guidance for industry 211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers... availability of a draft guidance for industry 211 entitled ``Residual Solvents in Animal ] Drug Products... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Solvents in Animal...

  11. 76 FR 59705 - Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological...

    Science.gov (United States)

    2011-09-27

    ... Refunds for Drug and Biological Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION... industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This... a guidance for industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological...

  12. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2010-09-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0459] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori; Availability AGENCY: Food...

  13. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Science.gov (United States)

    2013-12-04

    ...] Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under... Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance... choose to register as outsourcing facilities (outsourcing facilities) in registering with FDA. The draft...

  14. 76 FR 72951 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-11-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0386] Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human...

  15. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Science.gov (United States)

    2011-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0787] Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies...

  16. English Communicative Events and Skills Needed at the Workplace: Feedback from the Industry

    Science.gov (United States)

    Kassim, Hafizoah; Ali, Fatimah

    2010-01-01

    The constant and continuous need for the university to work towards producing graduates who meet and exceed the requirements of their chosen industry has prompted the effort to gather feedback from those industries. The effort by researchers of an engineering-based university in the East Coast Region of Malaysia to collect information on the…

  17. 78 FR 52931 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2013-08-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938... and Products, Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft...

  18. Regulatory risk in the utilities industry: An empirical study of the English-speaking countries

    International Nuclear Information System (INIS)

    Gaggero, Alberto A.

    2007-01-01

    The economic theory on regulation suggests that firms subject to incentive regulation, such as price cap, bear more risk than firms subject to cost plus regulation, such as rate of return regulation. This hypothesis is tested empirically using a sample of 93 regulated companies operating in six English-speaking countries: Australia, Canada, Ireland, New Zealand, UK and USA, during the period 1995-2004. I replicate the methodology of the existing literature and also apply panel data techniques to my sample. The results obtained do not support the hypothesis that price cap regulation imposes more risk. (author)

  19. Living above the shop: home, business, and family in the English "Industrial Revolution".

    Science.gov (United States)

    Barker, Hannah; Hamlett, Jane

    2010-01-01

    This article explores the living arrangements and familial relations of small business households in northwest English towns between 1760 and 1820. Focusing on evidence from inventories and personal writing, it examines the homes that such households lived and worked in and the ways in which space was ordered and used: indicating that access to particular spaces was determined by status. This study suggests both the continuance of the "household family" into the nineteenth century (rather than its more modern, "nuclear" variant) and the existence of keenly felt gradations of status within households making it likely that the constitution of "the family" differed according to one's place in the domestic hierarchy.

  20. Is the term substitution relevant to Pharmacognosy and/ or vegetable crude drug industry?

    Science.gov (United States)

    Selvam, A B D

    2010-09-01

    Since each and every drug plant has its own characteristic features, in terms of its botanical characters, chemical composition and therapeutic properties, considering the highly potential drug plants as genuine plant and less potential (allied or non-allied) drug plants as substitutes is unjustifiable. Moreover, the term Substitution is being used for a couple of centuries in a wrong sense in pharmacognostic studies or in the vegetable crude drug industry. Therefore, the term 'Substitution' has to be replaced by the relevant and appropriate term, 'Alternative' or 'Alternative source'.

  1. 77 FR 20825 - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for...

    Science.gov (United States)

    2012-04-06

    ...] Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information...

  2. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Science.gov (United States)

    2011-05-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document... of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Class II...

  3. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Science.gov (United States)

    2011-12-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

  4. 75 FR 32952 - Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially...

    Science.gov (United States)

    2010-06-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0281] Draft Guidance for Industry and Food and Drug Administration Staff; ```Harmful and Potentially Harmful... Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff...

  5. 77 FR 69634 - Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing...

    Science.gov (United States)

    2012-11-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals... Effectiveness of Anticoccidial Drugs in Food-Producing Animals.'' The guidance provides guidance to industry for...

  6. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-03-19

    ... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...

  7. Drug and alcohol abuse: the bases for employee assistance programs in the nuclear-utility industry

    Energy Technology Data Exchange (ETDEWEB)

    Radford, L.R.; Rankin, W.L.; Barnes, V.; McGuire, M.V.; Hope, A.M.

    1983-07-01

    This report describes the nature, prevalence, and trends of drug and alcohol abuse among members of the US adult population and among personnel in non-nuclear industries. Analogous data specific to the nuclear utility industry are not available, so these data were gathered in order to provide a basis for regulatory planning. The nature, prevalence, and trend inforamtion was gathered using a computerized literature, telephone discussions with experts, and interviews with employee assistance program representatives from the Seattle area. This report also evaluates the possible impacts that drugs and alcohol might have on nuclear-related job performance, based on currently available nuclear utility job descriptions and on the scientific literature regarding the impairing effects of drugs and alcohol on human performance. Employee assistance programs, which can be used to minimize or eliminate job performance decrements resulting from drug or alcohol abuse, are also discussed.

  8. Globalization of the pharmaceutical industry: the physician's role in optimizing drug use.

    Science.gov (United States)

    Young, M D

    1990-11-01

    In this new era of globalization, the physician must consider cultural differences in choosing methods of disseminating information so that practitioners in diverse settings may optimize drug usage. In addition, increasing competition, stimulated by the imminent unification of the European market in 1992, demands that the industry physician be concerned with developing possible new indications and cost-effective applications. These factors will enhance roles for the medical affairs physician in the pharmaceutical industry.

  9. 78 FR 37231 - Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2013-06-20

    .... 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in... comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane...

  10. 76 FR 25696 - Guidance for Industry on Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products...

    Science.gov (United States)

    2011-05-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0322] Guidance for Industry on Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

  11. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Science.gov (United States)

    2012-08-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  12. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  13. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Science.gov (United States)

    2011-02-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  14. 75 FR 54637 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-09-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0285] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  15. 75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0515] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  16. Survey of industry and government programs to combat drug and alcohol abuse

    Energy Technology Data Exchange (ETDEWEB)

    Altman, W.; Brown, W.; Bush, L.; Cobb, L.I.

    1982-06-01

    The results of a Task Force survey of the drug and alcohol programs of ten licensed nuclear utilities, of two federal agencies, and of two large corporations not in the nuclear industry are described. The Task Force solicited, and reports on, utility management views on the extent of the drug and alcohol problem, company policies on the work-related use or possession of alcohol or drugs, and utility management views on proposed regulatory initiatives which would address the drug and alcohol question. The report also describes utility practice and perceptions on: the use of background investigations, psychological tests, supervisory training and behavioral observation, employee awareness programs, employee assistance and rehabilitation programs, and the use of chemical tests and other measures to detect drug and/or alcohol use. Nonnuclear programs reported on are: Department of Defense, Federal Aviation Administration, Kimberly-Clark Corporation, and General Motors Corporation. The Task Force's survey was limited generally to better drug and alcohol programs and discussions with corporate officials. The schedule for the survey did not permit the gathering of supporting data to determine the quantitative effectiveness of the programs reported on, or of drug and alcohol programs of the nuclear industry in general.

  17. Subjective Risk Assessment and Perception in the Greek and English Bakery Industries

    Science.gov (United States)

    Alexopoulos, Evangelos C.; Kavadi, Zafira; Bakoyannis, Giorgos; Papantonopoulos, Sotiris

    2009-01-01

    Several factors influencing risk perception in the area of occupational health and safety are known, but there is still lack of a full understanding of the ways in which people characterize risk. This study aimed to provide an insight of employee risk assessment and perception in the bakery industry. 87 British and 64 Greek employees in two comparable bakery companies were asked to estimate and evaluate hazards at their workplace. The participants' judgments of 12 hazards—according to 7 risk aspects—were collected and analyzed. Subjective assessment on important occupational hazards included handling heavy loads, repetitiveness, high temperatures, high rate of work, stressful deadlines, and noise. Although limited in the population involved, our findings revealed strong cross-national differences in employee risk perception of specific groups of hazards in the bakery industry. Additional interviews revealed evidence that Greek employees' risk perception depends mostly on work experience while British employees were aware of risks due to company health and safety policy, recognizing that safety is the responsibility of both the management and the worker. Cross-national (cultural) factors that influence workforce risk perception and attitudes towards safety have to be taken into account by technical experts and policy makers in the designing of prevention strategies and risk communication. PMID:20041018

  18. Subjective Risk Assessment and Perception in the Greek and English Bakery Industries

    International Nuclear Information System (INIS)

    Alexopoulos, E.C.; Kavadi, Z.; Bakoyannis, G.; Papantonopoulos, S.

    2010-01-01

    Several factors influencing risk perception in the area of occupational health and safety are known, but there is still lack of a full understanding of the ways in which people characterize risk. This study aimed to provide an insight of employee risk assessment and perception in the bakery industry. 87 British and 64 Greek employees in two comparable bakery companies were asked to estimate and evaluate hazards at their workplace. The participants judgments of 12 hazards according to 7 risk aspects were collected and analyzed. Subjective assessment on important occupational hazards included handling heavy loads, repetitiveness, high temperatures, high rate of work, stressful deadlines, and noise. Although limited in the population involved, our findings revealed strong cross-national differences in employee risk perception of specific groups of hazards in the bakery industry. Additional interviews revealed evidence that Greek employees risk perception depends mostly on work experience while British employees were aware of risks due to company health and safety policy, recognizing that safety is the responsibility of both the management and the worker. Cross-national (cultural) factors that influence workforce risk perception and attitudes towards safety have to be taken into account by technical experts and policy makers in the designing of prevention strategies and risk communication.

  19. Subjective Risk Assessment and Perception in the Greek and English Bakery Industries

    Directory of Open Access Journals (Sweden)

    Evangelos C. Alexopoulos

    2009-01-01

    Full Text Available Several factors influencing risk perception in the area of occupational health and safety are known, but there is still lack of a full understanding of the ways in which people characterize risk. This study aimed to provide an insight of employee risk assessment and perception in the bakery industry. 87 British and 64 Greek employees in two comparable bakery companies were asked to estimate and evaluate hazards at their workplace. The participants' judgments of 12 hazards—according to 7 risk aspects—were collected and analyzed. Subjective assessment on important occupational hazards included handling heavy loads, repetitiveness, high temperatures, high rate of work, stressful deadlines, and noise. Although limited in the population involved, our findings revealed strong cross-national differences in employee risk perception of specific groups of hazards in the bakery industry. Additional interviews revealed evidence that Greek employees' risk perception depends mostly on work experience while British employees were aware of risks due to company health and safety policy, recognizing that safety is the responsibility of both the management and the worker. Cross-national (cultural factors that influence workforce risk perception and attitudes towards safety have to be taken into account by technical experts and policy makers in the designing of prevention strategies and risk communication.

  20. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Science.gov (United States)

    2013-02-26

    ... Clinical Investigators.'' This guidance is intended to assist clinical investigators, industry, and FDA...-addressed adhesive label to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION...-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER...

  1. 78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

    Science.gov (United States)

    2013-06-07

    ... adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail... and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION... June 2013. FDA is providing this final guidance document to assist industry in developing technical and...

  2. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Science.gov (United States)

    2013-09-25

    ...] Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability...) is announcing the availability of the guidance entitled ``Mobile Medical Applications.'' The FDA is... to apply its regulatory authorities to select software applications intended for use on mobile...

  3. 75 FR 73108 - Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products...

    Science.gov (United States)

    2010-11-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0584... products submitted as ANDAs. It does not create or confer any rights for or on any person and does not...., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document...

  4. Protein crystallography and drug discovery: recollections of knowledge exchange between academia and industry

    Directory of Open Access Journals (Sweden)

    Tom L. Blundell

    2017-07-01

    Full Text Available The development of structure-guided drug discovery is a story of knowledge exchange where new ideas originate from all parts of the research ecosystem. Dorothy Crowfoot Hodgkin obtained insulin from Boots Pure Drug Company in the 1930s and insulin crystallization was optimized in the company Novo in the 1950s, allowing the structure to be determined at Oxford University. The structure of renin was developed in academia, on this occasion in London, in response to a need to develop antihypertensives in pharma. The idea of a dimeric aspartic protease came from an international academic team and was discovered in HIV; it eventually led to new HIV antivirals being developed in industry. Structure-guided fragment-based discovery was developed in large pharma and biotechs, but has been exploited in academia for the development of new inhibitors targeting protein–protein interactions and also antimicrobials to combat mycobacterial infections such as tuberculosis. These observations provide a strong argument against the so-called `linear model', where ideas flow only in one direction from academic institutions to industry. Structure-guided drug discovery is a story of applications of protein crystallography and knowledge exhange between academia and industry that has led to new drug approvals for cancer and other common medical conditions by the Food and Drug Administration in the USA, as well as hope for the treatment of rare genetic diseases and infectious diseases that are a particular challenge in the developing world.

  5. Protein crystallography and drug discovery: recollections of knowledge exchange between academia and industry.

    Science.gov (United States)

    Blundell, Tom L

    2017-07-01

    The development of structure-guided drug discovery is a story of knowledge exchange where new ideas originate from all parts of the research ecosystem. Dorothy Crowfoot Hodgkin obtained insulin from Boots Pure Drug Company in the 1930s and insulin crystallization was optimized in the company Novo in the 1950s, allowing the structure to be determined at Oxford University. The structure of renin was developed in academia, on this occasion in London, in response to a need to develop antihypertensives in pharma. The idea of a dimeric aspartic protease came from an international academic team and was discovered in HIV; it eventually led to new HIV antivirals being developed in industry. Structure-guided fragment-based discovery was developed in large pharma and biotechs, but has been exploited in academia for the development of new inhibitors targeting protein-protein interactions and also antimicrobials to combat mycobacterial infections such as tuberculosis. These observations provide a strong argument against the so-called 'linear model', where ideas flow only in one direction from academic institutions to industry. Structure-guided drug discovery is a story of applications of protein crystallography and knowledge exhange between academia and industry that has led to new drug approvals for cancer and other common medical conditions by the Food and Drug Administration in the USA, as well as hope for the treatment of rare genetic diseases and infectious diseases that are a particular challenge in the developing world.

  6. The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school.

    Science.gov (United States)

    Stanley, A G; Jackson, D; Barnett, D B

    2005-04-01

    Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK.

  7. Inhalation and dermal exposure to eight antineoplastic drugs in an industrial laundry facility.

    Science.gov (United States)

    Fransman, Wouter; Huizer, Daan; Tuerk, Jochen; Kromhout, Hans

    2007-04-01

    The aims of the study were to quantify levels of dermal and inhalation exposure to antineoplastic drugs in an industrial laundry service in the Netherlands and to test the removal efficiency of the washing procedure for removal of antineoplastic drugs. During four workdays dermal and inhalation exposure to eight frequently used antineoplastic drugs (cyclophosphamide, ifosfamide, methotrexate, 5-fluorouracil, etoposide, cytarabine, gemcitabine and chlorambucil) were measured for all job titles involved in handling unwashed laundry. To test the removal efficiency of the washing procedure, 10 x 10 cm sections were excised before and after the washing procedure. These sections were taken from 15 bed sheets that were collected in hospitals of patients who were treated with one of the selected antineoplastic drugs. During none of the four measurement days, detectable levels of any of the eight antineoplastic drugs (cyclophosphamide, ifosfamide, methotrexate, 5-fluorouracil, etoposide, cytarabine, gemcitabine, or chlorambucil) were found on workers' skin of hands or in any of the air samples. Only four out of the 15 bed sheets from patients that were treated with antineoplastic drugs appeared to be contaminated with detectable levels of antineoplastic drugs before the washing procedure (range 13.0-3,060 ng/100 cm(2)). After the pre-washing and after the complete washing procedure, no detectable levels of any of the eight antineoplastic drugs were found anymore in the selected bed sheets. The implementation of guidelines for working with antineoplastic drugs seems to be successful in reducing exposure to antineoplastic drugs of workers in this laundry facility to an acceptable, non-detectable level and to remove antineoplastic drug contamination from bed linen.

  8. 78 FR 9396 - Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early...

    Science.gov (United States)

    2013-02-08

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Alzheimer's Disease... a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of... demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer's disease that occur...

  9. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Science.gov (United States)

    2013-02-08

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco... guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked... civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic...

  10. 78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-08-14

    ... guidance entitled ``Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food... Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff,'' you... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0300...

  11. Developing drugs for treatment of atopic dermatitis in children (≥3 months to industry.

    Science.gov (United States)

    Siegfried, Elaine C; Jaworski, Jennifer C; Eichenfield, Lawrence F; Paller, Amy; Hebert, Adelaide A; Simpson, Eric L; Altman, Emily; Arena, Charles; Blauvelt, Andrew; Block, Julie; Boguniewicz, Mark; Chen, Suephy; Cordoro, Kelly; Hanna, Diane; Horii, Kimberly; Hultsch, Thomas; Lee, James; Leung, Donald Y; Lio, Peter; Milner, Joshua; Omachi, Theodore; Schneider, Christine; Schneider, Lynda; Sidbury, Robert; Smith, Timothy; Sugarman, Jeffrey; Taha, Sharif; Tofte, Susan; Tollefson, Megha; Tom, Wynnis L; West, Dennis P; Whitney, Lucinda; Zane, Lee

    2018-03-30

    Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for "the Agency's current thinking on a particular subject." Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices). © 2018 Wiley Periodicals, Inc.

  12. Lexis in Chinese-English Translation of Drug Package Inserts: Corpus-based Error Analysis and Its Translation Strategies.

    Science.gov (United States)

    Ying, Lin; Yumei, Zhou

    2010-12-01

    Error analysis (EA) has been broadly applied to the researches of writing, speaking, second language acquisition (SLA) and translation. This study was carried out based on Carl James' error taxonomy to investigate the distribution of lexical errors in Chinese-English (C-E) translation of drug package inserts (DPIs)(1), explore the underlying causes and propose some translation strategies for correction and reduction of lexical errors in DPIs. A translation corpus consisting of 25 DPIs translated from Chinese into English was established. Lexical errors in the corpus and the error causes were analyzed qualitatively and quantitatively. Some examples were used to analyze the lexical errors and their causes, and some strategies for translating vocabulary in DPIs were proposed according to Eugene Nida's translation theory. This study will not only help translators and medical workers reduce errors in C-E translation of vocabulary in DPIs and other types of medical texts but also shed light on the learning and teaching of C-E translation of medical texts.

  13. Globalization of the pharmaceutical industry: the physician's role in evaluating drug safety.

    Science.gov (United States)

    Beg, M M

    1990-11-01

    The trend toward uniformity of drug registration procedures due to imminent European Economic Community globalization has encouraged pharmaceutical companies to conduct studies on a worldwide basis. This standardization of methods will facilitate the "poolability" of efficacy and safety data generated by these international studies into a common database. With the internationalization of the pharmaceutical marketplace, physicians in industry may be required to collect and interpret such reports from all over the globe. The globalization of the pharmaceutical industry will thus broaden the opportunities for physician involvement in safety detection.

  14. 78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-08-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  15. 76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0500] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration...

  16. 76 FR 48870 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; Availability AGENCY: Food and Drug Administration...

  17. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  18. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  19. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Science.gov (United States)

    2012-05-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0384] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  20. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-06-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  1. 77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

    Science.gov (United States)

    2012-04-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0094] Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  2. 78 FR 24425 - Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-04-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0642] Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  3. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Science.gov (United States)

    2011-08-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...

  4. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Science.gov (United States)

    2012-07-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  5. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Science.gov (United States)

    2011-04-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  6. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Science.gov (United States)

    2011-12-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0817] Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  7. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...

  8. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Science.gov (United States)

    2011-12-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  9. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Science.gov (United States)

    2013-11-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1279] Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  10. 75 FR 53971 - Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions...

    Science.gov (United States)

    2010-09-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0367] Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  11. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Science.gov (United States)

    2012-10-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  12. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2010-09-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  13. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-06-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  14. 76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0189] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS...

  15. 75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0275] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability AGENCY: Food and Drug Administration, HHS. [[Page...

  16. 76 FR 44594 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0465] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems; Availability AGENCY: Food and Drug Administration, HHS...

  17. 76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-03-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0028] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS...

  18. 76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0645] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  19. 76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  20. 78 FR 35940 - Guidance for Industry on Codevelopment of Two or More New Investigational Drugs for Use in...

    Science.gov (United States)

    2013-06-14

    ...] Guidance for Industry on Codevelopment of Two or More New Investigational Drugs for Use in Combination... Investigational Drugs for Use in Combination.'' The guidance is intended to assist sponsors in the codevelopment... evidentiary expectations for the individual new investigational drugs and their use in combination, and the...

  1. 76 FR 36543 - Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and...

    Science.gov (United States)

    2011-06-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0469] Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability... and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical...

  2. From artisans to “factories”: the interpenetration of craft and industry in English cheese-making, c1650-1950

    OpenAIRE

    Blundel, Richard; Tregear, Angela

    2006-01-01

    This article traces the uneven development of English cheese-making, from its early commercialization to the eventual triumph of the “cheese factory.” The narrative shows how contemporary actors initiated and adapted to changes in technology, distribution, consumption, and regulation. It indicates that artisanal practices have both borrowed from, and become integrated with, industrial logics and strategies, exemplifying a process that Charles F. Sabel and Jonathan Zeitlin termed the “recombin...

  3. Designing Email Tasks for the Business English Classroom: Implications from a Study of Hong Kong's Key Industries

    Science.gov (United States)

    Evans, Stephen

    2012-01-01

    Email has revolutionised the way in which professionals work and companies operate, and yet has received surprisingly little scholarly attention in English for Specific Purposes and has an unexpectedly muted presence in many Business English textbooks. The dearth of research into email use in globalised business settings may be one of the factors…

  4. Lowering industry firewalls: pre-competitive informatics initiatives in drug discovery.

    Science.gov (United States)

    Barnes, Michael R; Harland, Lee; Foord, Steven M; Hall, Matthew D; Dix, Ian; Thomas, Scott; Williams-Jones, Bryn I; Brouwer, Cory R

    2009-09-01

    Pharmaceutical research and development is facing substantial challenges that have prompted the industry to shift funding from early- to late-stage projects. Among the effects is a major change in the attitude of many companies to their internal bioinformatics resources: the focus has moved from the vigorous pursuit of intellectual property towards exploration of pre-competitive cross-industry collaborations and engagement with the public domain. High-quality, open and accessible data are the foundation of pre-competitive research, and strong public-private partnerships have considerable potential to enhance public data resources, which would benefit everyone engaged in drug discovery. In this article, we discuss the background to these changes and propose new areas of collaboration in computational biology and chemistry between the public domain and the pharmaceutical industry.

  5. Innovator Organizations in New Drug Development: Assessing the Sustainability of the Biopharmaceutical Industry.

    Science.gov (United States)

    Kinch, Michael S; Moore, Ryan

    2016-06-23

    The way new medicines are discovered and brought to market has fundamentally changed over the last 30 years. Our previous analysis showed that biotechnology companies had contributed significantly to the US Food and Drug Administration approval of new molecular entities up to the mid-1980s, when the trends started to decline. Although intriguing, the focus on biotechnology necessarily precluded the wider question of how the biopharmaceutical industry has been delivering on its goals to develop new drugs. Here, we present a comprehensive analysis of all biopharmaceutical innovators and uncover unexpected findings. The present biopharmaceutical industry grew steadily from 1800 to 1950 and then stagnated for two decades, before a burst of growth attributable to the biotechnology revolution took place; but consolidation has reduced the number of active and independent innovators to a level not experienced since 1945. The trajectories and trends we observe raise fundamental questions about biopharmaceutical innovators and the sustainability of the drug-development enterprise. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0514] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance...

  7. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2011-05-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-D-0102] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and...

  8. 78 FR 54899 - Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug...

    Science.gov (United States)

    2013-09-06

    ... Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry..., information technology, and information management resources. As these variables change over time, FDA may... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0984...

  9. 76 FR 44935 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Science.gov (United States)

    2011-07-27

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Availability AGENCY: Food and Drug... technologies, and to provide greater clarity about changes that do not trigger the need for a new premarket...

  10. 77 FR 12311 - Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2012-02-29

    ...] Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY: Food and... Sprinkle.'' This guidance provides applicants preparing or submitting new drug applications (NDAs... that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads). In the...

  11. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2011-01-19

    ...] Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY... Labeled for Sprinkle.'' This draft guidance provides sponsors of new drug applications (NDAs), abbreviated... that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads). DATES...

  12. 78 FR 22887 - Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices...

    Science.gov (United States)

    2013-04-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0104] Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices Framework...-reactivity. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES...

  13. Toxicity Evaluation of Through Fish Bioassay Raw Bulk Drug Industry Wastewater After Electrochemical Treatment

    Directory of Open Access Journals (Sweden)

    S Satyanarayan

    2011-10-01

    Full Text Available Considering the high pollution potential that the synthetic Bulk Drug industry Wastewater (BDW possesses due to the presence of variety of refractory organics, toxicity evaluation is of prime importance in assessing the efficiency of the applied wastewater treatment system and in establishing the discharge standards. Therefore, in this study the toxic effects of high strength bulk drug industry wastewater before and after electrochemical treatment on common fish Lebistes reticulatus-(peter were studied under laboratory conditions. Results indicated that wastewater being very strong in terms of color, COD and BOD is found to be very toxic to the studied fish. The LC50 values for raw wastewater and after electrochemical treatment with carbon and aluminium electrodes for 24, 48, 72 and 96 hours ranged between, 2.5-3.6%, 6.8-8.0%, 5.0-5.8% respectively. Carbon electrode showed marginally better removals for toxicity than aluminium electrode. It was evident from the studies that electrochemical treatment reduces toxicity in proportion to the removal efficiency shown by both the electrodes. The reduction in toxicity after treatment indicates the intermediates generated are not toxic than the parent compounds. Furthermore, as the electrochemical treatment did not result in achieving disposal standards it could be used only as a pre-treatment and the wastewater needs further secondary treatment before final disposal.

  14. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Science.gov (United States)

    2012-04-13

    ... Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI 209... ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or...

  15. Analysis of spironolactone residues in industrial wastewater and in drug formulations by cathodic stripping voltammetry.

    Science.gov (United States)

    El-Shahawi, M S; Bashammakh, A S; Al-Sibaai, A A; Bahaidarah, E A

    2013-04-01

    The redox behavior of spironolactone (SP) drug in Britton-Robinson (BR) buffer of pH 2-11 was investigated by differential pulse cathodic stripping voltammetry (DPCSV) and cyclic voltammetry (CV) at hanging mercury dropping electrode (HMDE). At pH 9-10.5, the DPCSV of SP drug showed two cathodic peaks at -1.15 and -1.38 V at the HMDE vs. Ag/AgCl reference electrode. In the CV, at pH 9-10, the dependence of the cathodic peak current, I p , c and peak potential, E p , c of the second peak ( E p , c 2 ) on the scan rate ( ν ) and on the depolizer (SP) concentrations was typical of an electrode coupled (EC) chemical reaction type mechanism. The plot of I p , c at -1.380 V of the DPCSV vs. SP concentration at pH 9 was linear over the concentration range of 1.2×10 -10 -9.6×10 -7  M. The lower limit of detection (LLOD) and limit of quantification (LOQ) of the drug were 1.1×10 -11 and 4.14×10 -11  M, respectively. The method was successfully applied for the analysis of SP residues in industrial wastewater, in pure form (98.2±3.1%) and in drug formulations e.g. Aldactone® tablet (98.35±2.9%).The method was validated by comparison with HPLC and the official data methods.

  16. Development and Pharmacokinetic Evaluation of Industrially Viable Self-microemulsifying Drug Delivery Systems (SMEDDS) for Terbinafine.

    Science.gov (United States)

    Baheti, Ankit; Srivastava, Saurabh; Sahoo, Deepak; Lowalekar, Rohit; Panda, Bibhu Prasad; Padhi, Bijay Kumar; Raghuvanshi, Rajeev

    2015-01-20

    Objective: The aim of this study was to develop a formulation for lymphatic uptake with enhanced solubility of antifungal drug, terbinafine by use of self-microemulsifying drug delivery system (SMEDDS); suitable enough to be an industrially feasible and acceptable dosage form. Methods: Fabrication of pseudo ternary phase diagram was done with suitable oils, surfactants and co-surfactants. The optimized formulation was characterised for droplet size, polydispersity index, zeta potential, cross-polarized light microscopy, thermodynamic stability, viscosity, capsule compatibility and evaluated for in vitro- in vivo parameters. The formulation was tested in animal model for lymphatic uptake with and without chylomicron blocking agent followed by the pharmacokinetic evaluation of the same. Results: The self-emulsification time, droplet size, polydispersity index of the optimized formulation remained unaffected in different media (water, 0.1N HCl and phosphate buffer pH 6.8) over stability conditions and with time. Crossed-polarized light microscopy examination of diluted SMEDDS formulation indicated that the dispersion was an isotropically stable system. The rate of dissolution for SMEDDS formulation was almost double as compared to marketed formulation (Lamisil®). Current investigation indicated a potential for lymphatic uptake of lipid based SMEDDS formulation with enhanced solubility of the candidate drug terbinafine. The optimum formulation of terbinafine SMEDDS when orally administered to rat with and without chylomicron flow blocking agent (cycloheximide) showed the area under the curve (AUC0-48hrs) as 10168.17 ng h/ml and 7425.44 ng h/ml respectively indicating the absorption through the lymphatic route. Thus, the study shows use of SMEDDS formulation for the drug delivery by lymphatic uptake.

  17. 78 FR 78366 - Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability

    Science.gov (United States)

    2013-12-26

    ... licensed under the Public Health Service Act. The U.S.P. Salt Policy became official on May 1, 2013, and U... drug products that contain a salt. More accurate naming of drug products containing a salt helps health... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1566...

  18. 78 FR 75570 - Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered...

    Science.gov (United States)

    2013-12-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0889... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the... Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self...

  19. Use of toxicogenomics in drug safety evaluation: Current status and an industry perspective.

    Science.gov (United States)

    Vahle, John L; Anderson, Ulf; Blomme, Eric A G; Hoflack, Jean-Christophe; Stiehl, Daniel P

    2018-04-18

    Toxicogenomics held great promise as an approach to enable early detection of toxicities induced by xenobiotics; however, there remain questions regarding the impact of the discipline on pharmaceutical nonclinical safety assessment. To understand the current state of toxicogenomics in the sector, an industry group surveyed companies to determine the frequency of toxicogenomics use in in vivo studies at various stages of drug discovery and development and to assess how toxicogenomics use has evolved over time. Survey data were compiled during 2016 from thirteen pharmaceutical companies. Toxicogenomic analyses were infrequently conducted in the development phase and when performed were done to address specific mechanistic questions. Prior to development, toxicogenomics use was more frequent; however, there were significant differences in approaches among companies. Across all phases, gaining mechanistic insight was the most frequent reason cited for pursing toxicogenomics with few companies using toxicogenomics to predict toxicities. These data were consistent with the commentary submitted in response to survey questions asking companies to describe the evolution of their toxicogenomics strategy. Overall, these survey data indicate that toxicogenomics is not widely used as a predictive tool in the pharmaceutical industry but is used regularly by some companies and serves a broader role in mechanistic investigations and as a complement to other technologies. Copyright © 2018. Published by Elsevier Inc.

  20. Drug Facts

    Medline Plus

    Full Text Available ... Where Can Someone Find Treatment and Recovery Resources? Prevention Help Children and Teens Stay Drug-Free Talking ... You Used Drugs in the Past Drug Use Prevention Phone Numbers and Websites Search Share Listen English ...

  1. Industrialization

    African Journals Online (AJOL)

    Lucy

    importantly exploiting cheap labour for industrial purposes from the native population. 13 . During the colonial era manufacturing in the continent was generally at the handicraft and small scale levels. In some colonies this was supplemented by some relatively complex industries producing mainly for export, but also ...

  2. 78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  3. Pharmaceutical industry's barriers and preferences to conduct clinical drug trials in Finland: a qualitative study.

    Science.gov (United States)

    Keinonen, Tuija; Keränen, Tapani; Klaukka, Timo; Saano, Veijo; Ylitalo, Pauli; Enlund, Hannes

    2003-09-01

    The objectives of our study were to explore the barriers, preferences and attitudes of the pharmaceutical industry towards conducting clinical trials in Finland. In-depth semi-structured interviews were conducted with 18 representatives of the pharmaceutical industry with different amounts of experience of clinical trials. The interviews were audiotaped, transcribed verbatim and analysed qualitatively. Overall, the respondents had a positive attitude towards conducting clinical trials in Finland. The major barriers seemed to occur at the beginning of the trial and mostly consisted of bureaucratic obstacles. The informants hoped for a more positive attitude of the public sector, more flexibility in hospitals and professionalism in practical implementation, e.g. having special research centres or site management services. The most dismotivating factors were the high costs and the constraints imposed by bureaucracy. The variety in practices of local ethics committees was considered problematic, and the need for common standard operating procedures was pointed out. The smallest barriers were encountered in subject recruitment by the investigators and their clinical work, documentation, investigational product logistics and communication with the regulatory authorities. The quality, know-how and reliability of the study personnel, the tightening of time lines in general, an investigator register/pool and collaboration with media in disseminating information about clinical trials to the general public were reported as the most appealing factors. Training in GCP, mainly incorporated in the medical education programme, and a certificate or equivalent were generally considered necessary, though a voluntary system was preferred. The barriers and preferences pointed out suggest various improvements and ways to produce high-quality, GCP-compliant clinical drug research and to ensure the availability of sufficient conditions to carry out clinical trials also in the future.

  4. A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations.

    Science.gov (United States)

    Allan, M C

    1992-01-01

    To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text and additional readings are presented in an appendix. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction ;of the components

  5. 75 FR 21632 - Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle...

    Science.gov (United States)

    2010-04-26

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion... the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump--Premarket Notification... the Internet. To receive ``Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k...

  6. Industrialization

    African Journals Online (AJOL)

    Lucy

    . African states as ... regarded as the most important ingredients that went to add value to land and labour in order for countries ... B. Sutcliffe Industry and Underdevelopment (Massachusetts Addison – Wesley Publishing Company. 1971), pp.

  7. Industrialization

    OpenAIRE

    Blundel, Richard

    2016-01-01

    Industrialization, the historical development that saw cheesemaking transformed from a largely craft-based or artisanal activity, often located on a dairy farm, to a production process that, for the most part, takes place in large ‘cheese factories’ or creameries [See ARTISANAL]. The principal features of modern industrialized cheesemaking, which set it apart from traditional approaches include: high production volumes; sourcing of milk from multiple dairy herds; pasteurization and re-balanci...

  8. Industry

    Energy Technology Data Exchange (ETDEWEB)

    Bernstein, Lenny; Roy, Joyashree; Delhotal, K. Casey; Harnisch, Jochen; Matsuhashi, Ryuji; Price, Lynn; Tanaka, Kanako; Worrell, Ernst; Yamba, Francis; Fengqi, Zhou; de la Rue du Can, Stephane; Gielen, Dolf; Joosen, Suzanne; Konar, Manaswita; Matysek, Anna; Miner, Reid; Okazaki, Teruo; Sanders, Johan; Sheinbaum Parado, Claudia

    2007-12-01

    This chapter addresses past, ongoing, and short (to 2010) and medium-term (to 2030) future actions that can be taken to mitigate GHG emissions from the manufacturing and process industries. Globally, and in most countries, CO{sub 2} accounts for more than 90% of CO{sub 2}-eq GHG emissions from the industrial sector (Price et al., 2006; US EPA, 2006b). These CO{sub 2} emissions arise from three sources: (1) the use of fossil fuels for energy, either directly by industry for heat and power generation or indirectly in the generation of purchased electricity and steam; (2) non-energy uses of fossil fuels in chemical processing and metal smelting; and (3) non-fossil fuel sources, for example cement and lime manufacture. Industrial processes also emit other GHGs, e.g.: (1) Nitrous oxide (N{sub 2}O) is emitted as a byproduct of adipic acid, nitric acid and caprolactam production; (2) HFC-23 is emitted as a byproduct of HCFC-22 production, a refrigerant, and also used in fluoroplastics manufacture; (3) Perfluorocarbons (PFCs) are emitted as byproducts of aluminium smelting and in semiconductor manufacture; (4) Sulphur hexafluoride (SF{sub 6}) is emitted in the manufacture, use and, decommissioning of gas insulated electrical switchgear, during the production of flat screen panels and semiconductors, from magnesium die casting and other industrial applications; (5) Methane (CH{sub 4}) is emitted as a byproduct of some chemical processes; and (6) CH{sub 4} and N{sub 2}O can be emitted by food industry waste streams. Many GHG emission mitigation options have been developed for the industrial sector. They fall into three categories: operating procedures, sector-wide technologies and process-specific technologies. A sampling of these options is discussed in Sections 7.2-7.4. The short- and medium-term potential for and cost of all classes of options are discussed in Section 7.5, barriers to the application of these options are addressed in Section 7.6 and the implication of

  9. [Drug advertising as communication between the pharmaceutical industry and the physician: advertisements for psychotropic drugs in the Dutch medical journal, Nederlands Tijdschrift voor Geneeskunde, 1900-1940].

    Science.gov (United States)

    van der Hoogte, Arjo Roersch; Pieters, Toine

    2010-01-01

    In this article we explore the historical development of drug advertisements for psychotropic drugs in the leading Dutch medical journal from 1900 to 1940. The advertisements for hypnotics and sedatives, in The Nederlands Tijdschrift voor Geneeskunde (Dutch medical journal) reflected the changes in the vocabulary and image promoted by the pharmaceutical companies. In the first two decades, the advertisements were sober and to the point, and included the trademark, company name, molecular formula and therapeutic properties of the medication. The emphasis was on creating a scientific image of reliable symptom control for the therapeutic drug. In doing so, the ethical drug companies tried (successfully) to distinguish themselves from the producers of patent medicines. Once scientific credibility was established, the form and content of the advertisements changed significantly. In the late 1920s and 1930s drug companies embraced modern advertising techniques, developing a figurative language to address the changing beliefs and practices of Dutch physicians. Instead of promoting therapeutic drugs as safe and scientific, the emphasis was on their effectiveness in comparison to similar drugs. In the process, scientific information was reduced to an indispensable standardized minimum, whereby therapeutic drugs were advertised according to the latest pharmacological taxonomy rather than molecular formulas. The image-making of 'ethical marketing' began during the interwar years when marketers applied modern advertising techniques and infotainment strategies. The scanty black and white informational bulletins transitioned into colourful advertisements. The pharmaceutical companies employed the same medical language as used by physicians, so that one word or image in an advertisement would suffice for the physician to recognize a drug and its therapeutic properties. These developments show the changing relationship between the modern ethical pharmaceutical industry and Dutch

  10. Industry

    OpenAIRE

    Schmidt-Belz, B.; Mohamad, Y.; Velasco, C.A.

    2009-01-01

    Industry plays a key role in the path towards eInclusion. While corporate social responsibility statements of leading companies confirm this, surveys show that there is still a long way to go. Among various reasons for the reluctant take-up of Design for All (DfA) by industry providing Information and Communication Technology (ICT), the lack of relevant knowledge and skills obviously plays a crucial role. Therefore, the DfA@eInclusion project has undertaken to develop curriculum guidelines an...

  11. The Pharmaceutical Industry in 2017. An Analysis of FDA Drug Approvals from the Perspective of Molecules.

    Science.gov (United States)

    de la Torre, Beatriz G; Albericio, Fernando

    2018-02-27

    This is an analysis from a chemical point of view of the 46 drugs (34 New Chemical Entities and 12 Biologics) approved by the FDA during 2017. The drugs included in the 2017 "harvest" have been classified on the basis of their chemical structure: biologics (antibodies and proteins); peptides; amino acids and natural products; drug combinations; and small molecules.

  12. Assessing the relative efficiency of water companies in the English and Welsh water industry: a metafrontier approach.

    Science.gov (United States)

    Molinos-Senante, María; Maziotis, Alexandros; Sala-Garrido, Ramon

    2015-11-01

    The assessment of relative efficiency of water companies is essential for managers and authorities. This is evident in the UK water sector where there are companies with different services such as water and sewerage companies (WaSCs) and water-only companies (WoCs). Therefore, it is a critical limitation to estimate a common production frontier for both types of companies, as it might lead to biased efficiency estimates. In this paper, a robust and reliable methodology, the metafrontier model, is applied to compare the efficiency of water companies providing different services. The results illustrate the superior performance of WaSCs compared to WoCs. It also confirms the presence of economies of scope in the UK water industry. The methodology and results of this study are of great interest for both regulators and water utility managers to make informed decisions.

  13. 76 FR 36307 - Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use-Revision of...

    Science.gov (United States)

    2011-06-22

    .... FDA-2011-D-0404] Guidance for Industry on Topical Acne Drug Products for Over-the- Counter Human Use... entities entitled ``Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and... recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug...

  14. Drug Facts

    Medline Plus

    Full Text Available ... Numbers and Websites Search Share Listen English Español Information about this page Click on the button that ... about drug abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana ...

  15. Progressive MS Alliance Industry Forum: Maximizing Collective Impact To Enable Drug Development.

    Science.gov (United States)

    Zaratin, P; Comi, G; Coetzee, T; Ramsey, K; Smith, K; Thompson, A; Panzara, M

    2016-10-01

    The Progressive MS Alliance Industry Forum describes a new approach to address barriers to developing treatments for progressive multiple sclerosis (MS). This innovative model promises to facilitate robust collaboration between industry, academia, and patient organizations and accelerate research towards the overarching goal of developing safe and effective treatments for progressive MS. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. Chronic Exposure of Early Stages of Development of Japanese Oyster to Contaminants from the Industry in the English Channel. Stress Markers at Integrated and Molecular Level

    International Nuclear Information System (INIS)

    Devos, Alexandre

    2013-01-01

    This thesis explores the effects of pollutants from the industry in the English Channel, in particular radionuclides, on the early stages of development of the Japanese oyster Crassostrea gigas. Original experimental devices were designed to study in laboratory controlled conditions the growth of a large number of larvae and spats. Emphasis was given to a joint use of stress markers at integrated and molecular levels. First exposures to non-radioactive pollutants revealed a highly sensitive response of the growth of juveniles exposed to a metal (zinc). Thereafter, juveniles were exposed for several weeks to dose rates of ionizing radiation and radionuclide activities several orders of magnitude higher than the levels likely to be encountered in the marine environment. An eco-geno-toxicological approach contributed to the understanding of the effects of ionizing radiations on DNA. The results strongly suggest that biochemical mechanisms act efficiently against radio-induced damages as early as the first days of life of the Japanese oyster. It still remains a lack of information about the long-term effects of DNA damages to higher level of biological organization. (author) [fr

  17. 76 FR 60504 - Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products...

    Science.gov (United States)

    2011-09-29

    ....'' This guidance describes a two-step process on how to request that a new condition be added to the over... covered by an OTC drug monograph need not obtain FDA approval before marketing if their drug product meets... for evaluation. This two-step process allows applicants to demonstrate that eligibility criteria are...

  18. Transparency in the pharmaceutical industry - A cost accounting approach to the prices of drugs

    NARCIS (Netherlands)

    Broekhof, Martijn

    2002-01-01

    The WTO TRIPS agreement grants pharmaceutical companies patent rights on new innovative drugs. Patents give these companies the opportunity to charge higher prices for their drugs in order to recover their R&D expenses. For developing countries this is one of the reasons why people in developing

  19. 78 FR 66744 - Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2013-11-06

    ...: Developing Drugs for Treatment.'' The purpose of the draft guidance is to assist sponsors in the development...-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY... Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR...

  20. Estimating the market for tuberculosis drugs in industrialized and developing nations.

    Science.gov (United States)

    Schwalbe, N R; Wells, W A; Geaneotes, A P; Forcellina, A; Lee, M G; Dicola, L; Ignatius, H R; Walker, C L; Raafat, T; Patel, N

    2008-10-01

    The successful introduction of new drugs into low- and middle-income countries requires an understanding of the existing market size and market dynamics for the therapeutic area of interest. The drug markets in these countries are, however, less well understood than those in high-income countries. The global market for tuberculosis (TB) drugs was estimated by studying in detail six high-burden countries and four high-income countries, followed by extrapolation. Data were derived from existing pharmaceutical audit databases and interviews with government officials, medical staff and suppliers. The use of qualitative inputs to inform the collection of quantitative information, notably to identify where the major flows of TB drugs are located, allowed a confident estimate of the global market for first-line TB drugs. Final ranges were US$261-316 million or US$310-418 million, depending on whether case notification rates or incidence were used for extrapolations. An estimation of the global TB drug market is made more reliable by a qualitative understanding of TB drug distribution pathways, which differ greatly among countries. The understanding of this structure in key high-burden countries provides the basis for a simpler update of the market estimate in the future.

  1. 77 FR 59928 - Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for...

    Science.gov (United States)

    2012-10-01

    ... bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. This draft... infection caused by bacterial pathogens that show resistance to most antibacterial drugs on in vitro...

  2. [Drug addiction prevention in the workplace--feasibility study in a company from the chemical industry].

    Science.gov (United States)

    Croissant, B; Klein, O; Löber, S; Mann, K

    2004-01-01

    In recent years drug prevention at the place of work has became increasingly important for programmes focussing on health promotion at the place of work. Drug prevention programmes aim at reducing cost and protecting the employees from physical harm. There are virtually no reliable figures from surveys in companies. To date intervention programme in companies have hardly been verified. In this feasibility study we intended to examine the practicability of an evaluation of an intervention programme in a large chemical company by means of questionnaires and we present preliminary intervention effects. In the context of a pilot study we conducted and evaluated a drug prevention programme at the place of work. Focus was on illegal designer drugs. The programme was conducted as a one-day workshop for trainers in superior management positions. We used a feedback form and a detailed questionnaire on drug prevention in the working place. 41 trainers who participated in the seminar were compared with a control group of 12 trainers who did not participate. The intervention programme was well accepted by the participants. Follow-up data demonstrated, that participants in the seminar had far better knowledge of the employment agreement on addiction and drugs and of the possible ways to get help and they were far more active in realising the employment agreement. To achieve a long-term improvement of drug abuse in companies it is not enough to include and implement a passage on drug abuse and addiction in the employment agreement. Well-instructed trainers talk far often with colleagues displaying abnormal or addictive behaviour, resulting in more rapid therapeutic interventions.

  3. Industry Perspective on Contemporary Protein-Binding Methodologies: Considerations for Regulatory Drug-Drug Interaction and Related Guidelines on Highly Bound Drugs.

    Science.gov (United States)

    Di, Li; Breen, Christopher; Chambers, Rob; Eckley, Sean T; Fricke, Robert; Ghosh, Avijit; Harradine, Paul; Kalvass, J Cory; Ho, Stacy; Lee, Caroline A; Marathe, Punit; Perkins, Everett J; Qian, Mark; Tse, Susanna; Yan, Zhengyin; Zamek-Gliszczynski, Maciej J

    2017-12-01

    Regulatory agencies have recently issued drug-drug interaction guidelines, which require determination of plasma protein binding (PPB). To err on the conservative side, the agencies recommend that a 0.01 lower limit of fraction unbound (f u ) be used for highly bound compounds (>99%), irrespective of the actual measured values. While this may avoid false negatives, the recommendation would likely result in a high rate of false positive predictions, resulting in unnecessary clinical studies and more stringent inclusion/exclusion criteria, which may add cost and time in delivery of new medicines to patients. In this perspective, we provide a review of current approaches to measure PPB, and important determinants in enabling the accuracy and precision in these measurements. The ability to measure f u is further illustrated by a cross-company data comparison of PPB for warfarin and itraconazole, demonstrating good concordance of the measured f u values. The data indicate that f u values of ≤0.01 may be determined accurately across laboratories when appropriate methods are used. These data, along with numerous other examples presented in the literature, support the use of experimentally measured f u values for drug-drug interaction predictions, rather than using the arbitrary cutoff value of 0.01 as recommended in current regulatory guidelines. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  4. The Drug Discovery and Development Industry in India-Two Decades of Proprietary Small-Molecule R&D.

    Science.gov (United States)

    Differding, Edmond

    2017-06-07

    This review provides a comprehensive survey of proprietary drug discovery and development efforts performed by Indian companies between 1994 and mid-2016. It is based on the identification and detailed analysis of pharmaceutical, biotechnology, and contract research companies active in proprietary new chemical entity (NCE) research and development (R&D) in India. Information on preclinical and clinical development compounds was collected by company, therapeutic indication, mode of action, target class, and development status. The analysis focuses on the overall pipeline and its evolution over two decades, contributions by type of company, therapeutic focus, attrition rates, and contribution to Western pharmaceutical pipelines through licensing agreements. This comprehensive analysis is the first of its kind, and, in our view, represents a significant contribution to the understanding of the current state of the drug discovery and development industry in India. © 2017 The Author. Published by Wiley-VCH Verlag GmbH & Co. KGaA.

  5. Spurious and counterfeit drugs: a growing industry in the developing world.

    Science.gov (United States)

    Gautam, C S; Utreja, A; Singal, G L

    2009-05-01

    Spread of spurious/counterfeit/substandard drugs is a modern day menace which has been recognised internationally, especially so in developing countries. The problem assumes added significance in view of rapid globalisation. The market of spurious and counterfeit drugs is a well-organised, white collar crime. Poverty, high cost of medicines, lack of an official supply chain, legislative lacunae, easy accessibility to computerised printing technology, ineffective law enforcement machinery, and light penalties provide the counterfeiters with an enormous economic incentive without much risk. The consequences of the use of such medicines may vary from therapeutic failure to the occurrence of serious adverse events and even death. Proper drug quality monitoring, enforcement of laws and legislation, an effective and efficient regulatory environment, and awareness and vigilance on part of all stakeholders can help tackle this problem.

  6. China English and ELT for English Majors

    Science.gov (United States)

    Zhang, Mingjuan

    2008-01-01

    This paper is a general study of one of varieties of English--China English and its influence on English Language Teaching (ELT) for English majors. The status of English as an International language breaks the situation in which British English or American English is the sole standard. English becomes World Englishes, taking on a plural form,…

  7. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Science.gov (United States)

    2013-01-22

    ... intends to provide the underlying principles to determine the type of marketing submission that may be... industry and FDA staff on the underlying principles to determine the type of marketing submission that may... Modifications to a Combination Product Approved Under Certain Marketing Applications; Availability AGENCY: Food...

  8. Legal suits: pharmaceutical industry strategies to introduce new drugs in the Brazilian public healthcare system.

    Science.gov (United States)

    Chieffi, Ana Luiza; Barata, Rita de Cássia Barradas

    2010-06-01

    To assess the distribution rate of legal suits according to drug (manufacturer), prescribing physician, and attorney filing the lawsuit. A descriptive study was carried out to assess the lawsuits in the São Paulo State (Southeastern Brazil) courts registry in 2006, and amounts spent in complying with these lawsuits, and total costs with medication thus resulting. In 2006, the São Paulo State Administration spent 65 million Brazilian reais in compliance with court decisions to provide medication to approximately 3,600 individuals. The total cost of the medication was 1.2 billion Brazilian reais. In the period studied, 2,927 lawsuits were examined. These lawsuits were filed by 565 legal professionals, among which 549 were attorneys engaged by private individuals (97.17% of the total legal professionals). The drugs scope of the lawsuits had been prescribed by 878 different physicians. By assessing the number of lawsuits filed per attorney, it was found that 35% of them were brought before the courts by 1% of them. The data related to the lawsuits and to the medication classified according to manufacturer, show that a small number of attorneys is responsible for the largest number of lawsuits filed to obtain these drugs. The finding that more than 70% of the lawsuits filed for certain drugs are the responsibility of one single attorney, may suggest a close connection between this professional and the manufacturer.

  9. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Science.gov (United States)

    2010-10-25

    ... Development Tools.'' In March 2006, FDA issued the ``Critical Path Opportunities Report'' and the ``Critical Path Opportunities List.'' In these reports, FDA described six key areas along the critical path to... technical methods was needed to improve the efficiency of drug development. Too often, attention to a needed...

  10. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Science.gov (United States)

    2010-01-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0559... Approval (PMA) Applications.'' It does not create or confer any rights for or on any person and does not... a copy of the draft guidance may do so by using the Internet. To receive ``Heart Valves...

  11. Drug repurposing in pharmaceutical industry and its impact on market access: market access implications.

    Science.gov (United States)

    Murteira, Susana; Millier, Aurélie; Toumi, Mondher

    2014-01-01

    Drug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and combination. This study aimed to identify the determinants of successful market access outcome for drug repurposing in the United States of America (USA) and in Europe. The case studies of repurposing strategies were identified through a systematic review of the literature. Price information and reimbursement conditions for all the case studies were collected mainly through access of public datasources. A list of attributes that could be associated with market access outcome (price level and reimbursement conditions) was developed, discussed, and validated by an external expert group. Detailed information for all attributes was researched and collected for each case study. Bivariate regression models were conducted to identify factors associated with price change for all repurposing cases. A similar analysis was performed for reformulation and repositioning cases, in the USA and in Europe, separately. A significance level of 5% was used for all analyses. A total of 144 repurposing case studies were included in the statistical analysis for evaluation of mean price change. Combination cases (the combination of two or more individual drug components) were excluded from the statistical analysis due to the low number of cases retrieved. The main attributes associated with a significant price increase for overall repurposing cases were 'change in administration setting to hospital' (374%, ptarget product had a different administration route than the source product, and having a similar brand name for repurposed and original products, were variables that impacted a positive price change for repurposed drugs overall. Our research results also suggested that orphan designation could have a positive impact for repositioning in the USA, in particular. Although a change

  12. Earphone English.

    Science.gov (United States)

    Goldsmith, Francisca

    2002-01-01

    Describes Earphone English, a student club sponsored through a partnership between Berkeley High School and the Berkeley Public Library that offers students whose primary language is not English to practice their spoken and aural English skills. Discusses the audiobooks used in the program and the importance of multicultural content and age…

  13. Applying green analytical chemistry for rapid analysis of drugs: Adding health to pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Nazrul Haq

    2017-02-01

    Full Text Available Green RP-HPLC method for a rapid analysis of olmesartan medoxomil (OLM in bulk drugs, self-microemulsifying drug delivery system (SMEDDS and marketed tablets was developed and validated in the present investigation. The chromatographic identification was achieved on Lichrosphere 250 × 4.0 mm RP C8 column having a 5 μm packing as a stationary phase using a combination of green solvents ethyl acetate:ethanol (50:50% v/v as a mobile phase, at a flow rate of 1.0 mL/min with UV detection at 250 nm. The proposed method was validated for linearity, selectivity, accuracy, precision, reproducibility, robustness, sensitivity and specificity. The utility of the proposed method was verified by an assay of OLM in SMEDDS and commercial tablets. The proposed method was found to be selective, precise, reproducible, accurate, robust, sensitive and specific. The amount of OLM in SMEDDS and commercial tablets was found to be 101.25% and 98.67% respectively. The proposed method successfully resolved OLM peak in the presence of its degradation products which indicated stability-indicating property of the proposed method. These results indicated that the proposed method can be successfully employed for a routine analysis of OLM in bulk drugs and commercial formulations.

  14. Design research and industrial applicability

    DEFF Research Database (Denmark)

    Andreasen, Mogens Myrup

    1997-01-01

    Imprinted paper (copies of overheads in English) on the nature of design research, the transformation process for industrial utilization and the challenges of ENDREA from industry.......Imprinted paper (copies of overheads in English) on the nature of design research, the transformation process for industrial utilization and the challenges of ENDREA from industry....

  15. Industry Perspective on Standardizing Food-Effect Studies for New Drug Development.

    Science.gov (United States)

    Marroum, Patrick J; Nuthalapati, Silpa; Parikh, Apurvasena; Shebley, Mohamad; Hoffman, David; Zha, Jiuhong; Khatri, Amit; Awni, Walid M

    2018-02-19

    Investigating the effect of food on bioavailability during the development of an oral drug product is of prime importance because it has major implications on the study design of the clinical trials and dosing and administration recommendations. For modified-release formulations that exhibit dose dumping when administered with food, this may result in clinical concerns around safety and efficacy. In this article, we provide an overview of the various considerations in our opinion that impact the design and conduct of food-effect studies. We summarize the various recommendations from the different regulatory agencies and provide specific suggestions on study conduct in terms of statistical design, timing of studies, subject selection, and type and caloric content of the meal. We also discuss the role of modeling and simulation. Finally, we present an interpretation of the results of food-effect studies in addition to dosing and labeling recommendations in relation to regulatory guidance documents.

  16. Drug Facts

    Medline Plus

    Full Text Available ... the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos Information About Drugs ... adicción. English Español About the National Institute on Drug Abuse (NIDA) | About This Website Tools and Resources | Contact ...

  17. Drug Facts

    Medline Plus

    Full Text Available ... to main content Easy-to-Read Drug Facts Search form Search Menu Home Drugs That People Abuse Alcohol Facts ... Past Drug Use Prevention Phone Numbers and Websites Search Share Listen English Español Information about this page ...

  18. Drug Facts

    Medline Plus

    Full Text Available ... Prevention Phone Numbers and Websites Search Share Listen English Español Information about this page Click on the ... información sobre el abuso de drogas, y adicción. English Español About the National Institute on Drug Abuse ( ...

  19. Drug Facts

    Medline Plus

    Full Text Available ... Phone Numbers and Websites Search Share Listen English Español Information about this page Click on the button ... sobre el abuso de drogas, y adicción. English Español About the National Institute on Drug Abuse (NIDA) | ...

  20. 76 FR 20689 - Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability

    Science.gov (United States)

    2011-04-13

    ... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22... authorizations of antiviral drugs for influenza. This guidance is being issued consistent with FDA's good...

  1. Graphical display of histopathology data from toxicology studies for drug discovery and development: An industry perspective.

    Science.gov (United States)

    Brown, Alan P; Drew, Philip; Knight, Brian; Marc, Philippe; Troth, Sean; Wuersch, Kuno; Zandee, Joyce

    2016-12-01

    Histopathology data comprise a critical component of pharmaceutical toxicology studies and are typically presented as finding incidence counts and severity scores per organ, and tabulated on multiple pages which can be challenging for review and aggregation of results. However, the SEND (Standard for Exchange of Nonclinical Data) standard provides a means for collecting and managing histopathology data in a uniform fashion which can allow informatics systems to archive, display and analyze data in novel ways. Various software applications have become available to convert histopathology data into graphical displays for analyses. A subgroup of the FDA-PhUSE Nonclinical Working Group conducted intra-industry surveys regarding the use of graphical displays of histopathology data. Visual cues, use-cases, the value of cross-domain and cross-study visualizations, and limitations were topics for discussion in the context of the surveys. The subgroup came to the following conclusions. Graphical displays appear advantageous as a communication tool to both pathologists and non-pathologists, and provide an efficient means for communicating pathology findings to project teams. Graphics can support hypothesis-generation which could include cross-domain interactive visualizations and/-or aggregating large datasets from multiple studies to observe and/or display patterns and trends. Incorporation of the SEND standard will provide a platform by which visualization tools will be able to aggregate, select and display information from complex and disparate datasets. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Extramural English

    DEFF Research Database (Denmark)

    Jensen, Signe Hannibal

    activities are more supportive of language learning than others, i.e. gaming, watching television, music, etc. Finally, a qualitative gaming study will be carried out to explore what goes on linguistically when very young children game in English together: type of interaction between players...... and with the game and if this interaction can be seen to support their English language learning. Preliminary results indicate that although children use / are exposed to English in a range of different contexts and through a variety of modalities (internet, console/PC games, music etc.), the one activity...... that seems to have the most impact on children’s English learning is gaming....

  3. The mutual extraction industry: drug use and the normative structure of social capital in the Russian far north.

    Science.gov (United States)

    Pilkington, Hilary; Sharifullina, El'vira

    2009-05-01

    The article contributes to the literature on the role of social networks and social capital in young people's drug use. It considers the structural and cultural dimensions of the 'risk environment' of post-Soviet Russia, the micro risk-environment of a de-industrializing city in the far north of the country and the kind of social capital that circulates in young people's social networks there. Its focus is thus on social capital at the micro-level, the 'bridging' networks of peer friendship groups and the norms that govern them. The research is based on a small ethnographic study of the friendship groups and social networks of young people in the city of Vorkuta in 2006-2007. It draws on data from 32 respondents aged 17-27 in the form of 17 semi-structured audio and video interviews and field diaries. Respondents were selected from friendship groups in which drug use was a regular and symbolically significant practice. The risk environment of the Russian far north is characterised by major de-industrialization, poor health indicators, low life expectancy and limited educational and employment opportunities. It is also marked by a 'work hard, play hard' cultural ethos inherited from the Soviet period when risk-laden manual labour was well-rewarded materially and symbolically. However, young people today often rely on informal economic practices to generate the resource needed to fulfil their expectations. This is evident from the social networks among respondents which were found to be focused around a daily routine of generating and spending income, central to which is the purchase, sale and use of drugs. These practices are governed by norms that often invert those normally ascribed to social networks: reciprocity is replaced by mutual exploitation and trust by cheating. Social networks are central to young people's management of the risk environment associated with post-Soviet economic transformation. However, such networks are culturally as well as structurally

  4. The Role of Governmental Policies in Nurturing the Pharmaceutical Industry in Brazil: The Mix of Centralized Procurement, Public Drug Production and Public-private Partnerships

    OpenAIRE

    SORTE, JUNIOR Waldemiro Francisco

    2012-01-01

    Th World Health Organization estimates that only approximately one third of the world population have regular access to essential medication. Most of the deprived households are in developing countries. Studies on the pharmaceutical industry are thus particularly relevant for improving the health situation of the developing world and to increase new drug development for diseases that afflict the poor. Furthermore, as a knowledge-intensive sector, the pharmaceutical industry is of strategic im...

  5. English for Tourism and Hospitality Purposes (ETP)

    Science.gov (United States)

    Zahedpisheh, Nahid; Abu Bakar, Zulqarnain B.; Saffari, Narges

    2017-01-01

    The quick development of the tourism and hospitality industry can straightly influence the English language which is the most widely used and spoken language in international tourism in the twenty-first century. English for tourism has a major role in the delivery of quality service. Employees who work in the tourism and hospitality industry are…

  6. CALL English

    DEFF Research Database (Denmark)

    Barlach, Else

    This multimedia program of English grammar caters specifically for Danish students at Bachelor level. The handbook introduces students to well-established grammatical terminology within the traditional areas of English grammar, and the CD-ROM, which contains about 120 exercises, offers students...

  7. Analysis of the importance of drug packaging quality for end users and pharmaceutical industry as a part of the quality management system

    Directory of Open Access Journals (Sweden)

    Lončar Irma M.

    2013-01-01

    Full Text Available In this study, we collected and analyzed information on the importance of drug packaging quality to end users and pharmaceutical industry, as an indicator of the process of traceability and originality of drugs. Two surveys were conducted: one among the end users of drugs (252 patients and the other among professionals working in seven pharmaceutical companies in Serbia. For most end users (82.5% quality on the packaging of drugs was important, but only 41.8% of them thought that the appearance of the packaging could be an indicator of genuinity of drugs. The existence of the control marks (KM on drug packaging was not of great importance, since most of them (86.9% know, its function, but majority (60.2% would nevertheless decide to buy the drug without KM. Regarding the experts from the pharmaceutical industry, more then two-thirds of them (68.4% believed that the existence of KM did not contribute to efficient operations. Although a great number of pharmaceutical industry professionals (84.2% answered that the introduction of GS1 DataMatrix system would allow for complete traceability of the drug from the manufacturer to the end user, only 22.2% of them introduced this system to their products. This study also showed that domestic producers did not have a great interest for additional protection (special inks, holograms, special graphics, smart multicolor design, watermark, chemically labeled paper and cardboard etc.. on their products, given that only 15.8 % of them had some kind of additional protection against counterfeiting. Monitoring drug traceability from a manufacturer to end user is achieved by many complex activities regulated by law. A high percentage of responders said they were satisfied with the functionality of traceability systems used in their companies. As a way to increase the quality of drug packaging and business performance most responders saw in the continuous improvement of the system of traceability within the company

  8. 78 FR 38349 - Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics...

    Science.gov (United States)

    2013-06-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0575...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... conditions (expedited programs): Fast track designation, breakthrough therapy designation, accelerated...

  9. Method for manufacturing carrier containing e.g. proteins for human during oral drug delivery operation for food and drug administration application in pharmaceutical industry, involves providing active ingredient to core layer

    DEFF Research Database (Denmark)

    2015-01-01

    delivery operation for a food and drug administration (FDA) application in a pharmaceutical industry. ADVANTAGE - The method enables allowing an individual micro-structure stuck in an embossing stamp to be demolded under the conditions such that demolding operation is done by treating elastically...

  10. Drug Facts

    Medline Plus

    Full Text Available ... Say if You Used Drugs in the Past Drug Use Prevention Phone Numbers and Websites Search Share Listen English Español Information about this page Click on the button that says "Listen" on any page and the computer will read the ... Videos Information About ...

  11. Cardiovascular Mortality of Oral Antidiabetic Drugs Approved Before and After the 2008 US FDA Guidance for Industry: A Systemic Review and Meta-Analysis.

    Science.gov (United States)

    Goyat, Rashmi; Rai, Pragya; Chang, Jongwha; Ponte, Charles D; Tan, Xi

    2018-03-21

    Both diabetes and antidiabetic drugs (ADDs) increase the risk for cardiovascular (CV) diseases. Due to the increasing concern about CV safety associated with ADDs, the US FDA revised regulatory guidelines in 2008 to include CV safety as an endpoint. The objective of the current study was to conduct a systematic review with meta-analysis to compare CV mortality of oral ADDs approved before and after the FDA's 2008 guidance. Three electronic databases (PubMed, Scopus, and the Clinical Trial Registry) were searched to retrieve studies published up to 24 February 2017. Randomized clinical trials were included in this study if they (1) were published in the English language; (2) included adults with type 2 diabetes mellitus with or without CV risk factors, who were taking at least one oral antidiabetic drug; and (3) had at least one study outcome as CV mortality. Meta-analysis was performed using a random-effects model. Small-study effects were accessed using funnel plot symmetry. The primary outcome was CV mortality. We found that there was no significant increase in CV mortality for drugs approved before and after 2008. The overall odds ratio (OR) and the upper bound of the two-sided 95% confidence interval (CI) for all drugs approved after 2008 (OR 0.74, 95% CI 0.52-1.07) were lower than the overall OR for all drugs approved before 2008 (OR 1.03, 95% CI 0.89-1.19). In addition, the upper bounds of the two-sided 95% CI for both groups of drugs before and after 2008 were below 1.3. Empagliflozin, which was approved after the guidance, was significantly associated with a reduction in CV mortality. The 2008 FDA guidance appears to have a positive impact on CV risk assessment of recently marketed drugs for the management of diabetes.

  12. The Englishness of English Sedilia

    Directory of Open Access Journals (Sweden)

    James Alexander Cameron

    2017-06-01

    Full Text Available Sedilia are the ceremonial seats of the priest, deacon, and subdeacon placed to the south of the altar. In Gothic church architecture, they typically take the form of three deep niches, recessed into the thickness of the wall, surmounted by arches and separated by shafts. These types of sedilia are most well-known from English churches of the thirteenth and fourteenth centuries. This essay looks to explain why sedilia became so popular in England, through a consideration of trends in English architecture. With the help of Nikolaus Pevsner’s characterization of the country’s art from The Englishness of English Art, it will argue that the basic decorative language of sedilia is entrenched in trends first developed in the Anglo-Norman Romanesque. It will also suggest, however, that regional variations in the distribution of sedilia complicate the idea of a single “national style”.

  13. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-08-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0881...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...- identify, what information must be requested, how the information should be submitted to FDA, and what the...

  14. Opportunities for Data Science in the Pharmaceutical Industry: The Use of Data to Find Efficiencies in Drug Development Can?t Come Too Soon.

    Science.gov (United States)

    Keshava, Nirmal

    2017-01-01

    By the numbers, 2016 was not a good year for the U.S. pharmaceutical industry. As of early December, only 19 new drugs had been approved by the Food and Drug Administration (FDA), fewer than half of those approved in 2015 and the lowest number since 2007. Further, the FDA approved only 61% of submissions in 2016, compared to 95% in 2015 [1]. And, among the largest companies, the return on investment for research and development (R&D) fell to 3.7% [2].

  15. ENGLISH TRAINING

    CERN Multimedia

    2003-01-01

    If you wish to participate in one of the following courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at: http://www.cern.ch/Training/ or fill in an "application for training" form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. LANGUAGE TRAINING Françoise Benz tel. 73127 language.training@cern.ch PLACES AVAILABLE Writing Professional Documents in English This course is designed for people with a good level of spoken English who need to improve their professional writing (administrative, scientific, technical). Duration: 20 hours (2 hours a week) Price: 440 CHF (for 8 students) Date and timetable will be fixed when there are sufficient participants enrolled. Oral Expression This course is intended for people with a good knowledge of English who want to practise and maintain their sp...

  16. English Graphic

    OpenAIRE

    2012-01-01

    English Graphic is a book of essays on the subject of illustration, with the focus entirely on English artists using graphic media; drawings, prints and watercolours. As editor, I built on a schedule Tom drew up. It contains essays drawn from a variety of sources: the Great Works column, reviews, catalogue essays, and previously unpublished material. The historical span of the book is broad – from the Winchester Psalter Hellmouth to Harry Beck’s London Underground Map and Dom Sylvester Houéda...

  17. English Downfall

    Science.gov (United States)

    Theamishaugur

    2009-01-01

    In a remix of the infamous Hitler meme--taking a scene from the movie, "Downfall" (2005), and adding subtitles appropriate (in this case) for "Kairos" readers--theamishaugur makes a pointed, humorous (to some) commentary on the status of multimodal composition scholars in English departments during job market season.

  18. English Training

    CERN Multimedia

    2003-01-01

    General and Professional English Courses The next session will take place: from 03 March to 28 June 2003 (2 weeks break at Easter). These courses are open to all persons working on the Cern site, and to their spouses. For registration and further information on the courses, please consult our Web pages: http://cern.ch/Training or contact Mrs. Benz: tel.73127 or Mr. Liptow: tel.72957. Writing Professional Documents in English This course is designed for people with a good level of spoken English. Duration: 20 hours (2 hours a week) Price: 440 CHF (for 8 students) For registration and further information, please consult our Web pages: http://cern.ch/Training or contact Mrs. Tessa Osborne: Tessa.Osborne@cern. Oral Expression This course is intended for people with a good knowledge of English who want to practise and maintain their speaking skills while extending their vocabulary. There will be approximately 8 participants in a class. Speaking activities will include discussions, meeting simulations, rol...

  19. English Training

    CERN Multimedia

    2003-01-01

    General and Professional English Courses The next session will take place: from 03 March to 28 June 2003 (2 weeks break at Easter). These courses are open to all persons working on the Cern site, and to their spouses. For registration and further information on the courses, please consult our Web pages: http://cern.ch/Training or contact Mrs. Benz: tel.73127 or Mr. Liptow: tel.72957. Writing Professional Documents in English This course is designed for people with a good level of spoken English. Duration: 20 hours (2 hours a week) Price: 440 CHF (for 8 students) For registration and further information, please consult our Web pages: http://cern.ch/Training or contact Mrs. Tessa Osborne: Tessa.Osborne@cern. Oral Expression This course is intended for people with a good knowledge of English who want to practise and maintain their speaking skills while extending their vocabulary. There will be approximately 8 participants in a class. Speaking activities will include discussions, meeting simulations, role-p...

  20. English Phonetics

    DEFF Research Database (Denmark)

    for phoneticians, phonologists, and other linguists to locate and use, English Phonetics: Twentieth-Century Developments is a veritable treasure-trove. The gathered works are reproduced in facsimile, giving users a strong sense of immediacy to the texts and permitting citation to the original pagination...

  1. English courses

    CERN Document Server

    HR Department

    2010-01-01

    New courses University of Cambridge ESOL examination course We will be starting two new courses in October leading to the Cambridge First Certificate in English (level B2 of the European Framework) and the Cambridge Advanced English (level C1) examinations. These courses will consist of two semesters of 15 weeks with two two-hourly classes per week. There will be an average of eight students per class. Normally the examination will be taken in June 2011 but strong participants could take it earlier. People wishing to take these courses should enrol: http://cta.cern.ch/cta2/f?p=110:9:1927376177842004::NO::X_COURSE_ID,X_STATUS:4133%2CD and they will then be required to take a placement test to check that their level of English is of an appropriate level. Please note that we need a minimum of seven students enrolled to open a session. For further information please contact Tessa Osborne 72957. General and Professional English Courses The next session will take place: From 4th October 2010 to 5th Feb...

  2. Micro-sized TiO2 as photoactive catalyst coated on industrial porcelain grès tiles to photodegrade drugs in water.

    Science.gov (United States)

    Bianchi, Claudia L; Sacchi, Benedetta; Capelli, Sofia; Pirola, Carlo; Cerrato, Giuseppina; Morandi, Sara; Capucci, Valentino

    2017-04-27

    Pharmaceutical compounds and their metabolites raise worrying questions because of their continuous release and lack of efficient removal by conventional wastewater treatments; therefore, they are being detected in groundwater, surface water and drinking water in increasing concentrations. Paracetamol and aspirin are two of the most commonly used drugs employed as fever reducer, analgesic and anti-inflammatory. They and their metabolites are very often found in river water, so their degradation is necessary in order to render water suitable for human consumption. The present work is focused on the comparison of the photocatalytic performance of industrial active grés porcelain tiles covered with a commercial micro-sized TiO 2 by industrial process using either conventional spray deposition or innovative digital printing methods. The photodegradation of two commonly used drugs, namely aspirin and paracetamol, was investigated both individually and as a mixture, in both deionized and tap water. The results reveal the full conversion of the drugs and the significant role of the photocatalytic tiles in the mineralization processes leading to harmless inorganic species. In particular, the digitally printed tiles exhibited better photodegradation performance for both drugs compared to the spray deposited tiles. No deactivation was observed on both photocatalytic tiles.

  3. State-of-the-art and dissemination of computational tools for drug-design purposes: a survey among Italian academics and industrial institutions.

    Science.gov (United States)

    Artese, Anna; Alcaro, Stefano; Moraca, Federica; Reina, Rocco; Ventura, Marzia; Costantino, Gabriele; Beccari, Andrea R; Ortuso, Francesco

    2013-05-01

    During the first edition of the Computationally Driven Drug Discovery meeting, held in November 2011 at Dompé Pharma (L'Aquila, Italy), a questionnaire regarding the diffusion and the use of computational tools for drug-design purposes in both academia and industry was distributed among all participants. This is a follow-up of a previously reported investigation carried out among a few companies in 2007. The new questionnaire implemented five sections dedicated to: research group identification and classification; 18 different computational techniques; software information; hardware data; and economical business considerations. In this article, together with a detailed history of the different computational methods, a statistical analysis of the survey results that enabled the identification of the prevalent computational techniques adopted in drug-design projects is reported and a profile of the computational medicinal chemist currently working in academia and pharmaceutical companies in Italy is highlighted.

  4. Making out in English (English phrasebook)

    CERN Document Server

    Crownover, Richard

    2011-01-01

    Making Out in English is a fun, accessible and thorough English phrase book and guide to the English language as it's really spoken. If you are a student, businessman or tourist traveling to the English speaking world and would like to have an authentic and meaningful experience, the key is being able to speak like a local. This friendly and easy-to-use English phrasebook makes this possible. Making Out in English has been revised and redesigned to act as a guide to modern colloquial English for use in everyday informal interactions—giving access to the sort of catchy English expressions that

  5. 78 FR 28228 - Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...

    Science.gov (United States)

    2013-05-14

    ... does not address real-time active safety surveillance studies, as this field is still rapidly evolving... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057..., MD 20852. FOR FURTHER INFORMATION CONTACT: Regarding human drug products: Judy Staffa, Center for...

  6. English training

    CERN Multimedia

    2003-01-01

    You have a good level of English BUT... You still need to improve your speaking or You have problems writing professional documents Would you like to work in a small group on either of these areas? Then, the following courses are for you! Writing Professional Documents in English The aim of the course is for students to improve their professional writing. Participants will work on technical, scientific or administrative documents depending on the needs of the group. Duration: 20 hours (2 hours a week) Price: 440 CHF (for 8 students) Oral Expression The emphasis will be on oral expression with necessary feed-back. Speaking activities will include discussions, meeting simulations, role-plays etc. Duration: 20 hours (2 hours a week) Price: 440 CHF (for 8 students) For registration and further information, please consult our Web pages: http://cern.ch/Training or contact Mr. Liptow: tel. 72957 / Mrs. Tessa Osborne: Tessa.Osborne@cern.ch.

  7. English Training

    CERN Multimedia

    2003-01-01

    You have a good level of English BUT... You still need to improve your speaking or You have problems writing professional documents Would you like to work in a small group on either of these areas? Then, the following courses are for you! Writing Professional Documents in English The aim of the course is for students to improve their professional writing. Participants will work on technical, scientific or administrative documents depending on the needs of the group. Duration: 20 hours (2 hours a week) Price: 440 CHF (for 8 students) Oral Expression The emphasis will be on oral expression with necessary feed-back. Speaking activities will include discussions, meeting simulations, role-plays etc. Duration: 20 hours (2 hours a week) Price: 440 CHF (for 8 students) For registration and further information, please consult our Web pages: http://cern.ch/Training or contact Mr. Liptow: tel. 72957 / Mrs. Tessa Osborne: Tessa.Osborne@cern.ch.

  8. English in the Garment Shops.

    Science.gov (United States)

    Verplaetse, Lorrie

    This text for limited-English-speaking workers in the garment industry consits of illustrated vocabulary words, grammar lessons, narratives or brief readings, and exercises on employment-related topics. The first section focuses on shop talk, including job-specific vocabulary, simple expressions and explanations, social language, seeking and…

  9. English courses

    CERN Multimedia

    2013-01-01

    Cours d'anglais général et professionnel La prochaine session se déroulera du 4 mars jusqu’au 21 juin 2013. Ces cours s'adressent à toute personne travaillant au CERN ainsi qu'à leur conjoint. Pour le détail des cours proposés, consultez nos pages web. Oral Expression The next sessions will take place from 4 March to 21 June 2013. This course is intended for people with a good knowledge of English who want to enhance their speaking skills. There will be on average of 8 participants in a class. Speaking activities will include discussions, meeting simulations, role-plays etc. depending on the needs of the students. More information here. Writing Professional Documents in English - Administrative Writing Professional Documents in English - Technical The next sessions will take place from 4 March to 21 June 2013. These courses are designed for people with a goo...

  10. English course

    CERN Multimedia

    HR Department

    2011-01-01

    General and Professional English Courses The next sessions will take place: From 3rd October 2011 to beginning of February 2012 (break at Christmas). These courses are open to all persons working on the CERN site, and to their spouses. For registration and further information on the courses, please consult our Web pages: http://cern.ch/Training or contact Kerstin Fuhrmeister, tel. 70896. Oral Expression The next sessions will take place from 3rd October 2011 to beginning of February 2012 (break at Christmas). This course is intended for people with a good knowledge of English who want to enhance their speaking skills. There will be on average of 8 participants in a class. Speaking activities will include discussions, meeting simulations, role-plays etc. depending on the needs of the students. For registration and further information on the courses, please consult our Web pages: http://cern.ch/Training or contact Kerstin Fuhrmeister, tel. 70896. Writing Professional Documents in English - Administrative Wr...

  11. 78 FR 72900 - Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco...

    Science.gov (United States)

    2013-12-04

    ... Blvd., Rockville, MD 20850-3229. Send one self-addressed adhesive label to assist that office in... of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville...

  12. Redefining the Boundaries of Historical Writing and Historical Imagination in Carolyn Steedman’s Master and Servant: Love and Labour in the English Industrial Age

    Directory of Open Access Journals (Sweden)

    Lejla Mulalić

    2013-05-01

    Full Text Available One of the dominant features of the late 20th and early 21st century academic debates on the nature of history is a curious form of radicalism both in the ranks of defenders of traditional approaches to history/historiography and eloquent champions of postmodern theories. These debates will provide the context for my reading of Steedman’s Master and Servant, which probes disciplinary boundaries of history and fiction in order to explore the unhistoricised ways of love and labour in 18th century industrial Yorkshire. As Steedman inhabits the position of both a professional historian, with all the ideological implications of that position, and Nelly Dean, a servant and narrator in Brontë’s Wuthering Heights, this paper will consider her approach to historical imagination in the light of deconstructionist genre of historical writing.

  13. Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development-Industry Case Studies.

    Science.gov (United States)

    Kesisoglou, Filippos; Chung, John; van Asperen, Judith; Heimbach, Tycho

    2016-09-01

    In recent years, there has been a significant increase in use of physiologically based pharmacokinetic models in drug development and regulatory applications. Although most of the published examples have focused on aspects such as first-in-human (FIH) dose predictions or drug-drug interactions, several publications have highlighted the application of these models in the biopharmaceutics field and their use to inform formulation development. In this report, we present 5 case studies of use of such models in this biopharmaceutics/formulation space across different pharmaceutical companies. The case studies cover different aspects of biopharmaceutics or formulation questions including (1) prediction of absorption prior to FIH studies; (2) optimization of formulation and dissolution method post-FIH data; (3) early exploration of a modified-release formulation; (4) addressing bridging questions for late-stage formulation changes; and (5) prediction of pharmacokinetics in the fed state for a Biopharmaceutics Classification System class I drug with fasted state data. The discussion of the case studies focuses on how such models can facilitate decisions and biopharmaceutic understanding of drug candidates and the opportunities for increased use and acceptance of such models in drug development and regulatory interactions. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  14. English Education and Communication Studies: Ambiguity in the International Airway.

    Science.gov (United States)

    Aune, Adonica Schultz; Huglen, Mark; Lim, Dan

    In the airline industry, English is now the accepted medium of communication for all air traffic controllers and pilots. For international flights it is of vital importance to hundreds of airline passengers that English be spoken clearly and properly to execute proper procedures and to act decisively and safely. Airspeak, aviation English, or air…

  15. Academic-industrial relations before the blockbuster drugs: lessons from the Harvard Committee on Pharmacotherapy, 1939-1943.

    Science.gov (United States)

    Podolsky, Scott H; Greene, Jeremy A

    2011-04-01

    Increasing discussion has developed in recent years over the nature of the relationship between academic medicine and the pharmaceutical industry. This article narrates the history of a little-known attempt at Harvard Medical School between 1939 and 1943 to establish an interdisciplinary, academic-industrial Committee on Pharmacotherapy to enhance and rationalize the relationship between the field of academic research in pharmacotherapeutics and the pharmaceutical industry. Using original archival materials, the authors depict the functioning of the committee, which was headed by Soma Weiss and included such members as Fuller Albright, Henry Beecher, and Walter Cannon. The committee would be collectively funded by seven pharmaceutical companies and was to be predicated on collaboration, both across the entire university and between academia and industry. It was expected to transform the bench-to-bedside study and testing of therapeutic compounds, to redefine the teaching of pharmacotherapy, and to create a unified forum through which to discuss the overall academic-industrial relationship and more specific issues such as patents. Unfortunately, the program proved to be short-lived, the victim of such contingent factors as the untimely death of Soma Weiss and America's entry into World War II, as well as such more fundamental factors as the inadequate and temporary nature of the funding stream and unresolved tensions regarding the goals of the committee on the part of both the medical school and its industry supporters. Nevertheless, these early forays into collaborative bench-to-bedside translational research and the rationalization of academic-industrial relations remain instructive today. © by the Association of American Medical Colleges.

  16. Anguished English

    CERN Document Server

    Lederer, Richard

    2006-01-01

    Anguished English is the impossibly funny anthology of accidental assaults upon our common language. From bloopers and blunders to Signs of the Times to Mixed-Up Metaphors . . . from Two-Headed Headlines to Mangling Modifiers . . . it's a collection that will leave you roaring with delight and laughter.Help wanteds:Wanted: Unmarried girls to pick fresh fruit and produce at night.Two-Headed Headlines:Grandmother of eight makes hole in one!Doctor testifies in horse suit.Modern-Day Malapropisms:I suffer from a deviant septum.

  17. GPCR structure, function, drug discovery and crystallography: report from Academia-Industry International Conference (UK Royal Society) Chicheley Hall, 1-2 September 2014.

    Science.gov (United States)

    Heifetz, Alexander; Schertler, Gebhard F X; Seifert, Roland; Tate, Christopher G; Sexton, Patrick M; Gurevich, Vsevolod V; Fourmy, Daniel; Cherezov, Vadim; Marshall, Fiona H; Storer, R Ian; Moraes, Isabel; Tikhonova, Irina G; Tautermann, Christofer S; Hunt, Peter; Ceska, Tom; Hodgson, Simon; Bodkin, Mike J; Singh, Shweta; Law, Richard J; Biggin, Philip C

    2015-08-01

    G-protein coupled receptors (GPCRs) are the targets of over half of all prescribed drugs today. The UniProt database has records for about 800 proteins classified as GPCRs, but drugs have only been developed against 50 of these. Thus, there is huge potential in terms of the number of targets for new therapies to be designed. Several breakthroughs in GPCRs biased pharmacology, structural biology, modelling and scoring have resulted in a resurgence of interest in GPCRs as drug targets. Therefore, an international conference, sponsored by the Royal Society, with world-renowned researchers from industry and academia was recently held to discuss recent progress and highlight key areas of future research needed to accelerate GPCR drug discovery. Several key points emerged. Firstly, structures for all three major classes of GPCRs have now been solved and there is increasing coverage across the GPCR phylogenetic tree. This is likely to be substantially enhanced with data from x-ray free electron sources as they move beyond proof of concept. Secondly, the concept of biased signalling or functional selectivity is likely to be prevalent in many GPCRs, and this presents exciting new opportunities for selectivity and the control of side effects, especially when combined with increasing data regarding allosteric modulation. Thirdly, there will almost certainly be some GPCRs that will remain difficult targets because they exhibit complex ligand dependencies and have many metastable states rendering them difficult to resolve by crystallographic methods. Subtle effects within the packing of the transmembrane helices are likely to mask and contribute to this aspect, which may play a role in species dependent behaviour. This is particularly important because it has ramifications for how we interpret pre-clinical data. In summary, collaborative efforts between industry and academia have delivered significant progress in terms of structure and understanding of GPCRs and will be

  18. The cost of multiple sclerosis drugs in the US and the pharmaceutical industry: Too big to fail?

    Science.gov (United States)

    Hartung, Daniel M; Bourdette, Dennis N; Ahmed, Sharia M; Whitham, Ruth H

    2015-05-26

    To examine the pricing trajectories in the United States of disease-modifying therapies (DMT) for multiple sclerosis (MS) over the last 20 years and assess the influences on rising prices. We estimated the trend in annual drug costs for 9 DMTs using published drug pricing data from 1993 to 2013. We compared changes in DMT costs to general and prescription drug inflation during the same period. We also compared the cost trajectories for first-generation MS DMTs interferon (IFN)-β-1b, IFN-β-1a IM, and glatiramer acetate with contemporaneously approved biologic tumor necrosis factor (TNF) inhibitors. First-generation DMTs, originally costing $8,000 to $11,000, now cost about $60,000 per year. Costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%-60% higher than existing DMTs. Significant increases in the cost trajectory of the first-generation DMTs occurred following the Food and Drug Administration approvals of IFN-β-1a SC (2002) and natalizumab (reintroduced 2006) and remained high following introduction of fingolimod (2010). Similar changes did not occur with TNF inhibitor biologics during these time intervals. DMT costs in the United States currently are 2 to 3 times higher than in other comparable countries. MS DMT costs have accelerated at rates well beyond inflation and substantially above rates observed for drugs in a similar biologic class. There is an urgent need for clinicians, payers, and manufacturers in the United States to confront the soaring costs of DMTs. © 2015 American Academy of Neurology.

  19. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    Science.gov (United States)

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  20. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Science.gov (United States)

    2010-05-20

    ... Report Submission Program'' to the Division of Small Manufacturers, International, and Consumer... this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630... Ministry of Health, Labour and Welfare system. This notice of availability and draft guidance satisfy the...

  1. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Science.gov (United States)

    2012-03-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0226...) audit report provides FDA a degree of assurance of compliance with basic and fundamental quality management system requirements for medical devices. \\1\\ The GHTF founding members auditing systems include...

  2. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Science.gov (United States)

    2010-02-26

    ... Drugs and Biologics.'' The draft guidance provides sponsors and the review staff in FDA's Center for... guidance gives advice on various topics, such as what aspects of adaptive design clinical trials (i.e... and conducting adaptive design studies, what information to include in the adaptive design for FDA...

  3. 78 FR 63220 - Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for...

    Science.gov (United States)

    2013-10-23

    ... assist sponsors in the development of new antibacterial drugs to treat acute bacterial skin and skin..., rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office... Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center...

  4. 75 FR 53973 - Guidance for Industry; Small Entities Compliance Guide-Designation of New Animal Drugs for Minor...

    Science.gov (United States)

    2010-09-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0432... Health Act of 2004 (MUMS act) establishes new regulatory procedures that provide incentives intended to... other than cattle, horses, swine, chickens, turkeys, dogs, and cats) in the United States or to major...

  5. 78 FR 38058 - Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for...

    Science.gov (United States)

    2013-06-25

    ... contaminants and to recommend strategies to ensure that the heparin supply chain is not contaminated with OSCS... written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane...Tobacco/CDER/UCM206230.pdf . Users of this method should also review the Web site occasionally to ensure...

  6. The Implications of Colombian Drug Industry and Death Squad Political Violence for U.S. Counternarcotics Policy

    Science.gov (United States)

    1993-01-01

    34lOAording to DANE (Departamento Administrativo Nacional Estadistica ), the national statistical agency, nearly 80 percent of the criminal activity in Colombia ...death squad political violence on Colombia , and the consequences for U.S. counternarcotics policy. It was carried out as part of a larger project, Andean...drug trade, pose a grave threat to the political system in Colombia . An analysis of the political violence in Colombia shows that combined the two

  7. The Drug Discovery and Development Industry in India?Two Decades of Proprietary Small?Molecule R&D

    OpenAIRE

    Differding, Edmond

    2017-01-01

    Abstract This review provides a comprehensive survey of proprietary drug discovery and development efforts performed by Indian companies between 1994 and mid?2016. It is based on the identification and detailed analysis of pharmaceutical, biotechnology, and contract research companies active in proprietary new chemical entity (NCE) research and development (R&D) in India. Information on preclinical and clinical development compounds was collected by company, therapeutic indication, mode of ac...

  8. Performance comparison of two herbal and industrial medicines using nanoparticles with a starch/cellulose shell and alginate core for drug delivery: In vitro studies.

    Science.gov (United States)

    Esmaeili, Akbar; Behzadi, Sahar

    2017-10-01

    In this study, the performance of two kinds of industrial and herbal drugs encapsulated in nanoparticles with a shell of starch and cellulose and an alginate core were examined as a new technique for nanoparticle drug delivery. The test method involved creating a suspension of starch and alginate, which was then dried, mixed with cellulose, and heated to form core-shell nanoparticles. The industrial drug calcitonin and an extract of the herb Amaranthus retroflexcus L. were added separately and in combination to the nanoparticles, and the performance of each configuration was evaluated. Variables like shape, size of nanoparticle, and pH were examined for their effect in vitro. Response surface methodology (RSM) was employed for optimization of parameters. The properties of the nanoparticles were studied by scanning electron microscopy (SEM) and Ultraviolet-visible spectroscopy (UV-vis). The most optimal conditions for formation of the smallest nanoparticles were found to be pH 4 with a concentration of 0.15g starch, 0.04g alginate, and 0.01g cellulose, which resulted in a spherical nanoparticle size of 25.6-68.7nm. This novel method for helping bone regeneration offers a potentially major advance in the medical treatment of osteoporosis. The results of optimization indicated that the most optimal conditions of the tests were performed at pH 4, CA=0.04, CS=0.21, and CC=0.01. In acidic pH the size of nanoparticles was less than 100nm. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. How to create innovation by building the translation bridge from basic research into medicinal drugs: an industrial perspective.

    Science.gov (United States)

    Germann, Paul G; Schuhmacher, Alexander; Harrison, Juan; Law, Ronald; Haug, Kevin; Wong, Gordon

    2013-03-05

    The global healthcare industry is undergoing substantial changes and adaptations to the constant decline of approved new medical entities. This decrease in internal research productivity is resulting in a major decline of patent-protected sales (patent cliff) of most of the pharmaceutical companies. Three major global adaptive trends as driving forces to cope with these challenges are evident: cut backs of internal research and development jobs in the western hemisphere (Europe and USA), following the market growth potential of Asia by building up internal or external research and development capabilities there and finally, 'early innovation hunting' with an increased focus on identifying and investing in very early innovation sources within academia and small start-up companies. Early innovation hunting can be done by different approaches: increased corporate funding, establishment of translational institutions to bridge innovation, increasing sponsored collaborations and formation of technology hunting groups for capturing very early scientific ideas and concepts. This emerging trend towards early innovation hunting demands special adaptations from both the pharmaceutical industry and basic researchers in academia to bridge the translation into new medicines which deliver innovative medicines that matters to the patient. This opinion article describes the different modalities of cross-fertilisation between basic university or publicly funded institutional research and the applied research and development activities within the pharmaceutical industry. Two key factors in this important translational bridge can be identified: preparation of both partnering organisations to open up for new and sometime disruptive ideas and creation of truly trust-based relationships between the different groups allowing long-term scientific collaborations while acknowledging that value-creating differences are an essential factor for successful collaboration building.

  10. English Course

    CERN Multimedia

    HR Department

    2012-01-01

    Cours d'anglais général et professionnel : La prochaine session se déroulera : du 27 février au 22 juin 2012. Ces cours s'adressent à toute personne travaillant au CERN ainsi qu'à leur conjoint. Pour vous inscrire et voir tout le détail des cours proposés, consultez nos pages Web: http://cern.ch/Training Vous pouvez aussi contacter Kerstin Fuhrmeister, tél. 70896. Oral Expression The next sessions will take place from 27 February to 22 June, 2012.  This course is intended for people with a good knowledge of English who want to enhance their speaking skills. There will be on average of 8 participants in a class. Speaking activities will include discussions, meeting simulations, role-plays etc. depending on the needs of the students. For registration and further information on the courses, please consult our Web page: http://cern.ch/Training or contact Kerstin Fuhrmeister, tel. ...

  11. Japanese Media in English.

    Science.gov (United States)

    Tanaka, Sachiko Oda

    1995-01-01

    Describes the use of English in the media in Japan, focusing on the role and history of English-language newspapers, radio, and television programs, as well as the proliferation of English-language films shown in Japanese cinemas. Discusses the implications of English in the Japanese media. (20 references) (MDM)

  12. The Ownership of English.

    Science.gov (United States)

    Widdowson, H. G.

    1994-01-01

    A plenary address from the 1993 Teachers of English to Speakers of Other Languages (TESOL) Convention discusses the question of how English teachers delimit and design their world. Issues of standard English are raised, and it is noted that, if English serves the communicative and communal needs of different communities, it must be diverse. (One…

  13. English as "Tyrannosaurus Rex."

    Science.gov (United States)

    Swales, John M.

    1997-01-01

    The increasing domination of English as the world's leading medium of international professional communication has begun to impact English for Academic Purposes (EAP) programs, specifically the question of whether English is becoming too successful. The article argues that resistance to the "triumphalism" of English is a responsibility of EAP…

  14. English Teaching Profile: Poland.

    Science.gov (United States)

    British Council, London (England). English Language and Literature Div.

    A review of the status of English language instruction in Poland begins with an overview of the role of English in the society in general, and outlines the status of English use and instruction in the educational system at all levels (elementary, secondary, higher, adult, and teacher), the characteristics and training of English language…

  15. On Observing World English.

    Science.gov (United States)

    Urdang, Lawrence

    1990-01-01

    Reviews the current state of World English. Subjects addressed include standard accents and dialects, prejudicial attitudes toward nonstandard "local" usages, the use of English as the language of diplomacy, American influences on the language, and the fracturing of English in non-English-speaking countries around the world. (17 references) (JL)

  16. Conversational English Program, 1.

    Science.gov (United States)

    Instituto de Idiomas Yazigi, Sao Paulo (Brazil). Centro de Linguistica Aplicada.

    This first book of a conversational English program for adults contains an introductory section in Portuguese and exercises in English. The text centers around an English-speaking family from the United States that goes to live in Brazil. It contains color photographs with captions followed by exercises. The exercises are in English and involve…

  17. Conversational English Program, 2.

    Science.gov (United States)

    Instituto de Idiomas Yazigi, Sao Paulo (Brazil). Centro de Linguistica Aplicada.

    This second book of a conversational English program for adults contains an introductory section in Portuguese and exercises in English. The text centers around an English-speaking family from the United States that goes to live in Brazil. It contains color photographs with captions followed by exercises. The exercises are in English and involve…

  18. Introducing Business English

    NARCIS (Netherlands)

    Nickerson, C.; Planken, B.C.

    2015-01-01

    Introducing Business English provides a comprehensive overview of this topic, situating the concepts of Business English and English for Specific Business Purposes within the wider field of English for Special Purposes. This book draws on contemporary teaching and research contexts to demonstrate

  19. Web English --the future?

    OpenAIRE

    Monaghan, A. I. C.

    1998-01-01

    Electronic communication, and particularly the World Wide Web, is becoming increasingly indispensable in our daily lives. The vast majority of the information currently exchanged electronically is in English, and it might be assumed that this will promote the use of English. Rarely is the contrary view presented, that the adoption of English as a general-purpose medium for global communication will change the English language and perhaps even lead to the creation of a «Web English» which repl...

  20. English title

    Directory of Open Access Journals (Sweden)

    Francisco Quiles Torres

    2015-11-01

    Full Text Available Due to the limited time protection that a patent provides a new pharmaceutical product in the market, organizations need to be agile in launching them to maximize their return on investment and need qualified project managers to accomplish it. Competency models have been developed in the United States, which describes the required soft and hard skills that a manager must have in order to be successful in the execution of general as well as strategic projects, but is unknown if they would apply to the management of projects at the pharmaceutical industry in Puerto Rico. This research presents the competency model develop by Rodríguez (2005 and evaluates its applicability in determining the competences needed to manage projects in the pharmaceutical industry sector in Puerto Rico. Results demonstrate that the model has applicability in Puerto Rico, but the relative importance of every competency varied versus the results on the previous study, which indicates that the importance of the competencies may vary depending on the environment.

  1. Complaints, complainants, and rulings regarding drug promotion in the United Kingdom and Sweden 2004-2012: a quantitative and qualitative study of pharmaceutical industry self-regulation.

    Science.gov (United States)

    Zetterqvist, Anna V; Merlo, Juan; Mulinari, Shai

    2015-02-01

    more than ten times each. A qualitative content analysis of serious violations pertaining to diabetes drugs (UK, n = 15; Sweden, n = 6; 10% of serious violations) and urologics (UK, n = 6; Sweden, n = 13; 9%) revealed various types of violations: misleading claims (n = 23; 58%); failure to comply with undertakings (n = 9; 23%); pre-licensing (n = 7; 18%) or off-label promotion (n = 2; 5%); and promotion of prescription drugs to the public (n = 6; 15%). Violations that go undetected or unpunished by self-regulatory bodies are the main limitation of this study, since they are likely to lead to an underestimate of industry misconduct. The prevalence and severity of breaches testifies to a discrepancy between the ethical standard codified in industry Codes of Conduct and the actual conduct of the industry. We discuss regulatory reforms that may improve the quality of medicines information, such as pre-vetting and intensified active monitoring of promotion, along with larger fines, and giving greater publicity to rulings. But despite the importance of improving regulatory arrangements in an attempt to ensure unbiased medicines information, such efforts alone are insufficient because simply improving oversight and increasing penalties fail to address additional layers of industry bias.

  2. Complaints, complainants, and rulings regarding drug promotion in the United Kingdom and Sweden 2004-2012: a quantitative and qualitative study of pharmaceutical industry self-regulation.

    Directory of Open Access Journals (Sweden)

    Anna V Zetterqvist

    2015-02-01

    serious violation more than ten times each. A qualitative content analysis of serious violations pertaining to diabetes drugs (UK, n = 15; Sweden, n = 6; 10% of serious violations and urologics (UK, n = 6; Sweden, n = 13; 9% revealed various types of violations: misleading claims (n = 23; 58%; failure to comply with undertakings (n = 9; 23%; pre-licensing (n = 7; 18% or off-label promotion (n = 2; 5%; and promotion of prescription drugs to the public (n = 6; 15%. Violations that go undetected or unpunished by self-regulatory bodies are the main limitation of this study, since they are likely to lead to an underestimate of industry misconduct.The prevalence and severity of breaches testifies to a discrepancy between the ethical standard codified in industry Codes of Conduct and the actual conduct of the industry. We discuss regulatory reforms that may improve the quality of medicines information, such as pre-vetting and intensified active monitoring of promotion, along with larger fines, and giving greater publicity to rulings. But despite the importance of improving regulatory arrangements in an attempt to ensure unbiased medicines information, such efforts alone are insufficient because simply improving oversight and increasing penalties fail to address additional layers of industry bias.

  3. Complaints, Complainants, and Rulings Regarding Drug Promotion in the United Kingdom and Sweden 2004–2012: A Quantitative and Qualitative Study of Pharmaceutical Industry Self-Regulation

    Science.gov (United States)

    Zetterqvist, Anna V.; Merlo, Juan; Mulinari, Shai

    2015-01-01

    companies were in serious violation more than ten times each. A qualitative content analysis of serious violations pertaining to diabetes drugs (UK, n = 15; Sweden, n = 6; 10% of serious violations) and urologics (UK, n = 6; Sweden, n = 13; 9%) revealed various types of violations: misleading claims (n = 23; 58%); failure to comply with undertakings (n = 9; 23%); pre-licensing (n = 7; 18%) or off-label promotion (n = 2; 5%); and promotion of prescription drugs to the public (n = 6; 15%). Violations that go undetected or unpunished by self-regulatory bodies are the main limitation of this study, since they are likely to lead to an underestimate of industry misconduct. Conclusions The prevalence and severity of breaches testifies to a discrepancy between the ethical standard codified in industry Codes of Conduct and the actual conduct of the industry. We discuss regulatory reforms that may improve the quality of medicines information, such as pre-vetting and intensified active monitoring of promotion, along with larger fines, and giving greater publicity to rulings. But despite the importance of improving regulatory arrangements in an attempt to ensure unbiased medicines information, such efforts alone are insufficient because simply improving oversight and increasing penalties fail to address additional layers of industry bias. PMID:25689460

  4. Dictionary of surfactants English/German and German/English

    Energy Technology Data Exchange (ETDEWEB)

    Siekmann, K.

    1987-01-01

    This dictionary is supplement to the monograph ''Surfactants in Consumer Products'' edited by Professor Dr. J. Falbe. It comprises approximately 3.200 keywords of the chemistry, technology and applications of surfactants in English/German and German/English. In the monograph the physical-chemical principles of action of the surfactants, their production and their application in laundry detergents, dishwashing detergents and cleaning agents as well as in cosmetics and toiletries are discussed. The technological aspects of application and formulation along with those of production and manufacturing processes are illustrated. Ecological and toxicological questions are probed in depth. Finally, important economic data concerning this branch of industry as well as an attempt to provide a perspective with regard to the future of the surfactant market round out the picture.

  5. Drugs, prisons, and harm reduction.

    Science.gov (United States)

    Hughes, Rhidian

    2003-01-01

    The use of drugs in society raises important considerations for health and social policy. Critical health and social care issues arise when drugs are used inside prisons. This paper argues that there is an urgent need for prison drug policies to adopt the principles of harm reduction. However, current policy orthodoxy emphasises the control of drugs and punishment for drug taking. Key components of harm reduction are operationalised in this article by exploring the potential for harm reduction in prison within the context of English drug policy. Whilst the focus is on English policy debates, the discussion will have wider international resonance. Copyright 2003 The Haworth Press, Inc.

  6. Teaching College English.

    Science.gov (United States)

    Ediger, Marlow

    College instructors of English need to use selected strands from the educational psychology arena in teaching so that students may achieve more optimally. Each student needs to experience a quality English curriculum. A quality English class emphasizes instructional procedures which are conducive to achieving, growing, and learning on the part of…

  7. English Teaching Profile: Brazil.

    Science.gov (United States)

    British Council, London (England). English Language and Literature Div.

    This review of the status of English language instruction in Brazil provides an overview of the Brazilian geographic, historical, and political context and the role of English in the society in general and in the educational system. The following topics are covered: an outline of the status of English use and instruction in the educational system…

  8. English in Vietnam.

    Science.gov (United States)

    Denham, P. A.

    1992-01-01

    The growing use of English in Vietnam is reviewed, along with the nation's linguistic history that exemplifies the close relationship between language and politics. The English curriculum in Vietnamese schools is described, and the future role of Outer Circle countries in English language teaching is considered. (19 references) (Author/LB)

  9. Moodling English Language Education

    Science.gov (United States)

    Coskun, Abdullah; Arslan, Abdullah

    2014-01-01

    This paper aims to emphasize the importance of using Moodle in foreign language learning and teaching by reviewing relevant literature and introducing a Moodle-based environment aiming to help English learners to practice their English by themselves. Firstly, the use of Moodle in education and more specifically in English Language Teaching is…

  10. English in Fiji.

    Science.gov (United States)

    Siegel, Jeff

    1989-01-01

    Traces the history of English in Fiji, especially in relation to education. The role of English in interethnic communication and as a language of wider communication with the outside world is discussed, and features of Fiji English, a local language variety, are described. (Author/CB)

  11. Noch Einmal:American English - British English (Once More: American English -- British English).

    Science.gov (United States)

    Botts, M.

    1980-01-01

    Replies critically to the article by D. K. Stevenson and R. J. Brunt, "Living English: Seeing the Forest in Spite of the Trees -- On Differences between American English and British English," in this journal, issue 1979/2. A reply by Stevenson and Brunt continues the controversy. (IFS/WGA)

  12. Sentential Negation in English

    Science.gov (United States)

    Mowarin, Macaulay

    2009-01-01

    This paper undertakes a detailed analysis of sentential negation in the English language with Chomsky's Government-Binding theory of Transformational Grammar as theoretical model. It distinguishes between constituent and sentential negation in English. The essay identifies the exact position of Negation phrase in an English clause structure. It…

  13. English Language Teaching in Indonesia.

    Science.gov (United States)

    Musthafa, Bachrudin

    2002-01-01

    Discusses the education system in Indonesia, the development of a national English syllabus, English in elementary and secondary schools and in higher education, private sector English courses, teacher preparation and professional development, and expatriate English teachers. (Author/VWL)

  14. Development potential of the English language learning tourism ...

    African Journals Online (AJOL)

    Travel in order to learn English has become an enormous global industry, and in recent years South Africa has started to feature more prominently in the plans of English language learning tourists from all over the world. While the academic product tends to be similar wherever it is offered, the potential for added value lies ...

  15. English Language Teaching Profile: Poland.

    Science.gov (United States)

    British Council, London (England). English-Teaching Information Centre.

    A profile of English language teaching in Poland is provided in outline form. The following topics are dealt with: the role of English in the country, teaching hours per week in English at each educational level, English language versus English literature, public examinations, syllabuses and textbooks, specialized English programs, adult English…

  16. Teacher of primary English

    CERN Multimedia

    2003-01-01

    Part-time teacher of primary English needed for September 2003 to teach English National Curriculum (KS2) and NLS to mother tongue or good second language English-speakers aged 7-10. 4 hours contact time per week, team planning, marking and meetings. Candidates should be English mother tongue qualified teachers, confident, flexible classroom practitioners and team players. For further details and how to apply see http://enpferney.org/staff_vacancies.htm English National Programme, Lycée International, Ferney-Voltaire (http://enpferney.org/)

  17. TEACHER OF ENGLISH NEEDED

    CERN Multimedia

    2002-01-01

    Part-time teacher of primary English needed for September 2002 to teach English National Curriculum (KS2) and NLS to mother tongue or good second language English-speakers aged 7-10. 4 hours contact time per week, team planning, marking and meetings. Candidates should be English mother tongue qualified teachers, confident, flexible classroom practitioners and team players. For further details and how to apply: engnat@hotmail.com or 04 50 40 82 66. Apply as soon as possible, and in any case before 8 July. English National Programme, Lycée International, Ferney-Voltaire.

  18. What is English?

    Directory of Open Access Journals (Sweden)

    Ulrikke Rindal

    2014-10-01

    Full Text Available This article considers the developing status of English in Norway, both as a language and as a school subject, making predictions about which ontological and epistemological perspectives will influence English language teaching (ELT in Norway towards 2030. Status quo and predictions for English in Norway is approached from two angles; the development of presiding language beliefs in linguistic science and in ELT practices from the 16th century to the present, and the more recent and rapid development of English as the foremost global language of communication. The article shows how English language beliefs and the status of English are made visible in the national subject curriculum and in the English language practices among Norwegian adolescent learners. The discussion suggests that English is increasingly characterised by those who use it as a second or later language, including Norwegians who negotiate the meanings of English in the ELT classroom. The article predicts that a logical development for Norwegian ELT is increased influence from social constructionist perspectives, in combination with the existing focus on communicative competence. The study shows that global circumstances related to the status of English are reciprocally related to local language beliefs among educational authorities, teachers and students, and that these have major implications for English as a discipline in lower and higher education.

  19. 21 CFR 803.13 - Do I need to submit reports in English?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Do I need to submit reports in English? 803.13... in English? (a) Yes. You must submit all written or electronic equivalent reports required by this part in English. (b) If you submit any reports required by this part in an electronic medium, that...

  20. THE BANGLADESHI EMPLOYMENT SECTOR: EMPLOYER PERSPECTIVES CONCERNING ENGLISH PROFICIENCY

    Directory of Open Access Journals (Sweden)

    Rubina Khan

    2012-07-01

    Full Text Available Abstract: This paper presents a brief summary of a study which was carried out to investigate how employers representing major employment sectors in the Bangladeshi Industry view the skills and English proficiency level of the current employees. Opinions were also solicited on what skills are required for fresh recruits. Semi-structured interviews were conducted with 30 employers representing the major employment sectors in Bangladeshi Industry. Results revealed the importance of English as an indispensible means of communication in the Bangladeshi corporate sector and showed that the business enterprises use extensive amounts of English. It also highlighted that the existent English proficiency of the employees was far below the required proficiency level. Recommendations were made to address the gap and prepare the youth to meet the demands of the global market. Keywords: English proficiency, competency, employability skills, global literacy skills

  1. Análise comparativa da concentração industrial e de turnover da indústria farmacêutica no Brasil para os segmentos de medicamentos de marca e genéricos Comparative analysis of the Industrial Concentration and Turnover of the pharmaceutical industry in Brazil for the segments of mark and generic drugs

    Directory of Open Access Journals (Sweden)

    Gerson Rosenberg

    2010-04-01

    Full Text Available Este artigo analisa a evolução da estrutura do segmento de medicamentos de marca e genéricos no Brasil a partir de 1997. Após a entrada dos medicamentos genéricos, constatou-se que não houve diminuição significativa da concentração na indústria farmacêutica brasileira, porém, o mesmo não ocorreu em nível mundial, verificando-se um aumento da concentração a partir de 2001, impulsionado pelo expressivo processo de fusões e aquisições nos últimos anos da década de 1990. Em relação ao turnover, notou-se que este foi muito baixo para o grupo das maiores empresas em ambos os segmentos de medicamentos. Entretanto, observa-se um elevado turnover com a entrada dos genéricos, mostrando o fortalecimento da indústria nacional. Verifica-se que o processo de fusões e aquisições entre empresas nacionais é pouco significativo, o que pode ser uma alternativa para as pequenas empresas farmacêuticas aumentarem a sua participação no mercado brasileiro.This paper analyzes the evolution of brand-name and generic drugs structure in Brazil since 1997. After the introduction of generic drugs it was not verified a significant decrease in the concentration of Brazilian pharmaceutical industry. The process of mergers and acquisitions in the 90's enhanced the process of concentration in the international market. However, a non-expressive turnover can be demonstrated in both pharmaceutical and generic markets. At the same time, the entrance of the generic industry in Brazil explains the invigoration of the national industry. The mergers and acquisitions process in the pharmaceutical industry is quite intense in Europe and in the USA, although in Brazil it is still not significant.

  2. Energy-Saving Opportunities for Manufacturing Companies, (English/Russian Fact Sheet) (Revised)

    Energy Technology Data Exchange (ETDEWEB)

    2011-07-01

    This English/Russian brochure describes the Industrial Technologies Program Save Energy Now model and provides information on tools and resources to help manufacturing facilities reduce industrial energy intensity.

  3. Energy-Saving Opportunities for Manufacturing Companies (English/Portuguese Brochure)

    Energy Technology Data Exchange (ETDEWEB)

    2011-07-01

    This English/Portuguese brochure describes the Industrial Technologies Program Save Energy Now model and provides information on tools and resources to help manufacturing facilities reduce industrial energy intensity.

  4. Bilingual Education and English Proficiency

    Science.gov (United States)

    Jepsen, Christopher

    2010-01-01

    In 2001, California instituted a statewide test measuring English proficiency for English learners, students who are not proficient in English. In 2003 and 2004, nearly 500,000 English learners in grades 1-5 took this test each year. The relationship between bilingual education receipt and English proficiency is estimated using value-added…

  5. Paperwork Plus: Literacy Materials for the Service Industry. Hotel Edition.

    Science.gov (United States)

    Bond, Judith; McGill, Teresa

    The instructional materials are intended for use in teaching vocational English and English literacy to limited-English-speaking personnel in the hotel industry. They are designed for learners at three instructional levels, and address job-specific literacy tasks. An introductory section describes the materials and offers suggestions for…

  6. ESL for Hotel/Hospitality Industry. Level: Beginner.

    Science.gov (United States)

    Western Suffolk County Board of Cooperative Educational Services, Northport, NY.

    This document contains eight lesson plans for a beginning course in work-related English for non-English or limited-English speaking entry-level employees in the hotel and hospitality industry. Course objectives include the following: helping participants understand and use job-specific vocabulary; receive and understand job-related instructions;…

  7. On the Applications of Modern Educational Technology in Maritime English Teaching from the Perspective of Constructivism

    Science.gov (United States)

    Cui, Zhongliang

    2010-01-01

    Nowadays maritime transportation has become a major modern logistics because of its large capacity and low cost. English plays a leading role in the industry of maritime transportation. It is the most important medium and an indispensable communication tool in international business and global marine industry. Maritime English teaching has made…

  8. English I. [Revised].

    Science.gov (United States)

    Spann, Margaret; And Others

    This manual for language arts instructors contains a basic core of instruction in English that provides updated and extensive vocationally related application of such basic English skills as reading, writing, and practical usage. Attention is also focused on assisting students with life and study skills. The material should be adapted to…

  9. Exploring Affixation in English

    African Journals Online (AJOL)

    unique firstlady

    One of the keys to mastering English spellings is mastering the processes of word formation. The mode of word formation can influence the spelling. The study of the meaningful parts of a word is known as morphology. Linguists have identified many ways in which English form its words which include borrowing from Latin ...

  10. English for Business Communication

    Science.gov (United States)

    Bhatia, Vijay K.; Bremner, Stephen

    2012-01-01

    The concept of Business English has undergone some major shifts in the last few years because of a number of developments, such as advances in genre theory and the coming together of English for Business Purposes and Business Communication, inspired by the realization that there is a gap to be bridged between the academy and the globalized…

  11. Nineteenth-Century English

    DEFF Research Database (Denmark)

    Fabricius, Anne

    2009-01-01

    The article reviews the book "Nineteenth-Century English: Stability and Change," by Merja Kytö, Mats Rydèn and Erik Smitterberg......The article reviews the book "Nineteenth-Century English: Stability and Change," by Merja Kytö, Mats Rydèn and Erik Smitterberg...

  12. Abbreviations in Maritime English

    Science.gov (United States)

    Yang, Zhirong

    2011-01-01

    Aiming at the phenomena that more and more abbreviations occur in maritime English correspondences, the composing laws of the abbreviations in maritime English correspondence are analyzed, and the correct methods to answer the abbreviations are pointed out, and the translation method of abbreviations are summarized in this article, and the…

  13. English for Global Peacekeeping

    Science.gov (United States)

    Crossey, Mark

    2008-01-01

    In this article, I discuss the work of the British Council's Peacekeeping English Project: why the British Council is undertaking this work, why is it being sponsored, what exactly is being done and what are the key issues in English for peacekeeping and other security forces.

  14. Learning English, Learning Science

    Science.gov (United States)

    Nelson, Virginia

    2010-01-01

    Using science notebooks effectively in the classroom can encourage students who are learning English to keep up and keep interested. English language proficiency might head the list of content areas that schools can teach properly and effectively through science. Amaral, Garrison, and Klentschy (2002) reported that a successful inquiry-based…

  15. English Grammar For Dummies

    CERN Document Server

    Ward, Lesley J

    2009-01-01

    If you're confused by commas, perplexed by pronouns, and plain terrified by tenses, English Grammar For Dummies will put your fears to rest. Packed with expert guidance, it covers everything from sentence basics to rules even your English teacher didn't know - if you want to brush up on your grammar, this is the only guide you'll ever need. Discover how to: avoid common grammatical errors; get to grips with apostrophes; structure sentences correctly; use verbs and find the right tense; and decide when to use slang or formal English.  

  16. Learner Views on English and English Language Teaching in China

    Science.gov (United States)

    Liu, Na; Lin, Chih-Kai; Wiley, Terrence G.

    2016-01-01

    Since the 1980s, China has represented one of the major growth areas in the world for English language education, and studying English has been a priority among its foreign language educational policies. As English has gained more popularity in China, some have noted the potential value of English as a means to greater educational access and…

  17. Teaching English through English: Proficiency, Pedagogy and Performance

    Science.gov (United States)

    Richards, Jack C.

    2017-01-01

    Most of the world's English language teachers speak English as a second or third language rather than as their first language. For many, their level of proficiency in English may not reach benchmarks established by their employers, raising the issue that is the focus of this article, namely, what kind of proficiency in English is necessary to be…

  18. Pharmacist-industry relationships.

    Science.gov (United States)

    Saavedra, Keene; O'Connor, Bonnie; Fugh-Berman, Adriane

    2017-12-01

    The purpose of this study was to document, in their own words, beliefs and attitudes that American pharmacists have towards the pharmaceutical industry and pharmacists' interactions with industry. An ethnographic-style qualitative study was conducted utilizing open-ended interviews with four hospital pharmacists, two independent pharmacists, two retail pharmacists and one administrative pharmacist in the Washington, DC, metropolitan area to elicit descriptions of and attitudes towards pharmacists' relationships with industry. Analysis of the qualitative material followed established ethnographic conventions of narrative thematic analysis. All pharmacists reported interactions with pharmaceutical company representatives. Most had received free resources or services from industry, including educational courses. Respondents uniformly believed that industry promotional efforts are primarily directed towards physicians. Although respondents felt strongly that drug prices were excessive and that 'me-too' drugs were of limited use, they generally had a neutral-to-positive view of industry-funded adherence/compliance programmes, coupons, vouchers, and copay payment programmes. Interviewees viewed direct-to-consumer advertising negatively, but had a generally positive view of industry-funded drug information. Pharmacists may represent a hitherto under-identified cohort of health professionals who are targeted for industry influence; expanding roles for pharmacists may make them even more attractive targets for future industry attention. Pharmacy schools should ensure that students learn to rely on unbiased information sources and should teach students about conflicts of interest and the risks of interacting with industry. Further research should be conducted on the extent to which pharmacists' attitudes towards their duties and towards drug assessment and recommendation are influenced by the pharmaceutical industry. © 2017 Royal Pharmaceutical Society.

  19. Variations in Written English

    National Research Council Canada - National Science Library

    Collins, Jeffrey

    2003-01-01

    .... The implication is that these five dimensions mark fundamental rhetorical "cut points" in written English, functioning as a heretofore hidden meso-layer linking micro-level linguistic decisions...

  20. Talk of a "Default" Drug Formulary Rattles Industry: CMS Could Move in That Direction for Marketplace Plans After 2019, but the Discussion Has Already Started.

    Science.gov (United States)

    Barlas, Stephen

    2018-02-01

    A proposed CMS rule promising to consider a federal default prescription drug benefit after 2019 has startled manufacturers, pharmacy benefit managers, P&T committees, and pharmacies alike. We consider the rationale and potential effects of such a rule.

  1. Teaching English through Movies

    OpenAIRE

    Groger, Kenneth

    2004-01-01

    In this paper I will offer some techniques on how to add stimulation and enjoyment to the study of English through watching movies. The reader will have a chance to examine how teachers can utilize movies in the classroom to generate significant language production. This paper will further demonstrate how movies provide a plethora of opportunities for learners to reinforce and integrate all four English language skills, while improving their ability to engage in discussions that elicit and en...

  2. My Hesitation to Speak English

    Science.gov (United States)

    Oda, Naruha

    2015-01-01

    Even though English was the author's favorite subject, she was not good at speaking in English, and always tried to avoid it. However, it did not matter because she did not have to speak to demonstrate her English ability. After entering university, her lack of confidence in speaking English became a major issue, and other students face the same…

  3. Attitudes Toward English in Malaysia.

    Science.gov (United States)

    Crismore, Avon; And Others

    1996-01-01

    A 16-item Likert Scale questionnaire was used to investigate the perceptions and attitudes of Malaysian teachers and students at the university level toward Malaysian English. The functionality of Malaysian English was accepted, but respondents were determined to learn Standard English because they viewed Malaysian English as "wrong…

  4. English Language Teaching Profile: Cyprus.

    Science.gov (United States)

    British Council, London (England). English-Teaching Information Centre.

    This profile in outline form of the English language teaching situation in Cyprus discusses the role of English within the Greek Cypriot community and within the educational system. Areas covered include English language requirements and English within the curriculum, teaching personnel and teacher training, instructional materials, English…

  5. English made easy

    CERN Document Server

    Crichton, Jonathan

    2013-01-01

    This is a fun and user–friendly way to learn English English Made Easy is a breakthrough in English language learning—imaginatively exploiting how pictures and text can work together to create understanding and help learners learn more productively. It gives learners easy access to the vocabulary, grammar and functions of English as it is actually used in a comprehensive range of social situations. Self–guided students and classroom learners alike will be delighted by the way they are helped to progress easily from one unit to the next, using a combination of pictures and text to discover for themselves how English works. The pictorial method used in this book is based on a thorough understanding of language structure and how language is successfully learned.English Made Easy, Volume 1 consists of a total of 20 units arranged in groups of five. The first four units presents language and provide learners the opportunities to practice as they learn. The first page of each unit has a list of all the word...

  6. English made easy

    CERN Document Server

    Crichton, Jonathan

    2013-01-01

    This is a fun and user–friendly way to learn EnglishEnglish Made Easy is a breakthrough in English language learning—imaginatively exploiting how pictures and text can work together to create understanding and help learners learn more productively. It gives learners easy access to the vocabulary, grammar and functions of English as it is actually used in a comprehensive range of social situations. Self–guided students and classroom learners alike will be delighted by the way they are helped to progress easily from one unit to the next, using a combination of pictures and text to discover for themselves how English works. The pictorial method used in this book is based on a thorough understanding of language structure and how language is successfully learned.English Made Easy, Volume 2 consists of a total of 20 units arranged in groups of five. The first four units presents language and provide learners the opportunities to practice as they learn. The first page of each unit has a list of all the words...

  7. English Tsunami in Indonesian

    Directory of Open Access Journals (Sweden)

    E. Sadtono

    2013-11-01

    Full Text Available English has successfully overwhelmed Indonesian like tsunami as an imperialistic language. The meaning of imperialism here, however, differs from the conventional meaning as it is invited imperialism, not coerced imperialism.The influence of English in Indonesian is discussed in terms of modernization, globalization, economy, and history. The linguistic tsunami effects are overwhelming, staggering, and unstoppable. The data for this article were collected from various sources, and it was found that the number of English words (pure and modified is indeed confounding. Virtually English words have penetrated all walks of life. Unfortunately, there is no way we can prevent English influence on Indonesian, it is simply inevitable and we cannot do anything about it. Seen from linguistic purism, we have lost the battle in fighting off English influence; but seen from the eye of a descriptive linguist, it is an unpreventable historical phenomenon. It is a lingusitic dynamism in which language is altered and enriched by a continuous input from other languages, the most influential language being the major donor of loanwords of the receiving language. If it is considered a problem, the solution is to change our attitude to realize that any living language continues undergoing modifications and we should be willing to accommodate them. It is the dialectics of world history.

  8. NEGATION AFFIXES IN ENGLISH

    Directory of Open Access Journals (Sweden)

    Dedy Subandowo -

    2017-02-01

    Full Text Available Abstract: This research entitled "Negation Affixes in English". This study is aimed to describe the various negation affixes in English, morphological process, morphophonemic and meaning. The research data were taken from various sources of English grammar book, morphology, research journal and the book which relatees to the research. English grammar books used in this study are written by Otto Jesperson, Marcella Frank, Greenbaum and Geoffrey Leech.  The method used in this research is the descriptive-qualitative method. While the data collection techniques are performed by using jot-down method. And the results of analysis are presented in tabular form and descriptive method. The result of the research shows that English has six types of negative affixes which are categorized by the intensity of its appearance, such as dis-, in-, non-, un-, anti- and -less. Based on the function, negation affixes are divided into several categories such as adjectives, nouns, verbs, and adverbs. The morphophonemic affix in- has four allomorphs, they are in-, im-, il- and ir- . While the analysis revealed that negation affixes have some basic meanings, such as ‘not’, ‘without’, and ‘anti’.

  9. School of Juridical English

    Directory of Open Access Journals (Sweden)

    I. G. Fedotova

    2014-01-01

    Full Text Available The Department of English Language № 8 works with students of the Faculty of International Law. The unique school of teaching legal aspects of the English language is one of the most significant achievements of the department. Associate Professor V.F. Nazarov was one of professionals, was at the origin of this school. In 1992 the textbook "The course of the legal interpretation of Anglo-American Commercial Law" was published, which was the result of work of group of specialists in legal translation since early 1970s. The book laid foundation for the further development of the school of teaching legal aspects of the English language. After1990stheteaching of the legal aspects of English language was brought to the next level, marked of the by the creation of the educational complex "Legal concepts and categories in the English language" by I.G. Fedotova and G.P. Tolstopyatenko, based on the new competence-based concept of educating professional international lawyers.

  10. Medicamentos genéricos no Brasil: impactos das políticas públicas sobre a indústria nacional Generic drugs in Brazil: impacts of public policies upon the national industry

    Directory of Open Access Journals (Sweden)

    Cristiane Quental

    2008-04-01

    Full Text Available O presente artigo faz eco a trabalhos recentes da Abrasco¹, Gadelha² e Guimarães³, que enfatizam a necessidade de uma maior integração entre as políticas voltadas para o desenvolvimento do sistema de saúde e aquelas voltadas para a promoção do desenvolvimento industrial e da inovação, como forma de garantir para o país os benefícios econômicos gerados pelos gastos em saúde, assegurando a continuidade da política social, num círculo virtuoso. Embora apresente o caso dos medicamentos genéricos como uma experiência de sucesso na integração das políticas sociais voltadas para um maior acesso da população a medicamentos com qualidade garantida, com as políticas econômicas voltadas para o desenvolvimento industrial, discute os impactos e as limitações da política dialogando com a análise da competitividade da indústria de medicamentos genéricos brasileira realizada por Abreu4.This paper echoes recent works of Abrasco¹, Gadelha² and Guimarães³ emphasizing the need for a better integration between health policies and industrial development and innovation policies as the only way to keep the economic benefits generated by health expenditures in the country instead of letting them escape through imports and threaten the continuity of the social policy by growing trade deficits. Although presenting the generic drug policy as a successful case in integrating social policies aimed at a better access to quality drugs for the population with economic policies aimed at industrial development, this paper discusses the impacts and limitations of the referred policy in a dialog with Abreu's analysis of industrial competitiveness in the Brazilian generics industry.

  11. Case study: to-BBB's G-Technology, getting the best from drug-delivery research with industry-academia partnerships.

    Science.gov (United States)

    Gaillard, Pieter J

    2011-11-01

    To-BBB aims to develop efficacious treatments for patients with devastating neurological conditions based on to-BBB's proprietary G-Technology that safely enhances the delivery of drugs across the blood-brain barrier. Through strategic research collaborations, a small company such as to-BBB is able to deliver the high-quality research necessary to develop these novel treatments.

  12. English for international journalists

    CERN Document Server

    Gandon, Mike

    2013-01-01

    English for International Journalists is a clear and engaging step-by-step guide for non-native speakers using English in journalism across all forms of media. In-depth language analysis is provided in the specialised context of journalism, as well as a comprehensive approach to the rules and guidelines necessary for avoiding the pitfalls and errors that undermine accuracy and clarity. The book, written by Mike Gandon and edited by Heather Purdey, covers a broad range of vital subjects, including: Making contact Interviewing Grammar and journalistic writing Sensitive issues The language of argument The language of impartial and accurate reporting Bloggers and broadcasters Reporting economy, health and the environment. The book is closely supported by online resources concentrating on the spoken word, intonation and pronunciation, and also features an expansive range of exercises and tests, suitable for self-study or to be set as coursework. English for International Journalists presents readers with ...

  13. English Book Club

    CERN Multimedia

    CERN English Book Club

    2010-01-01

    AGM  --  AGM  -- 2010 --  AGM  --  AGM The CERN ENGLISH BOOK CLUB will hold its 2010 AGM at 18h00 on Monday November 22nd in the club rooms (club barrack 564). Club members are invited to attend. Any members wishing to add points on to the agenda should contact one of the committee before November 12th. AGM  --  AGM  -- 2010 --  AGM  --  AGM The English Book Club has a collection of over 4500 English language books, mostly general fiction with a sprinkling of nonfiction and children’s books. New books are purchased regularly and the books are shelved in our club room which is accessible to members at all times. Membership is open to all (staff and external) and there is a special tariff for short term students. See the club’s website at http://cern.ch/englishbookclub for more details.  

  14. English Book Club

    CERN Multimedia

    English Book Club

    2012-01-01

    The CERN English Book Club will hold its 2012 AGM at 17h30 on Monday 5th March in the club rooms (club barrack 564). Club members are invited to attend. Any members wishing to add points on to the agenda should contact one of the committee before February 27th. The English Book Club has a collection of over 4500 English language books, mostly general fiction with a sprinkling of nonfiction and children’s books. New books are purchased regularly and the books are shelved in our club room which is accessible to members at all times. Membership is open to all (staff and external) and there is a special tariff for short term students. See the club’s website at http://cern.ch/englishbookclub for more details.

  15. Engaging with the ‘global’-‘local’ debate in English language teaching: professional identity and teaching practice

    OpenAIRE

    Le, Thi Thu Huyen

    2017-01-01

    The continuing expansion of English as a means of international communication has led to negative effects on other languages and cultures. Among the concerns is the critique of the English language teaching industry regarding its hegemonic relationship with local languages especially in English language teaching and learning contexts and practices. As a consequence, a move from previous paradigms of English language teaching to creatively devise new practices that would address locally emergi...

  16. SPOTLIGHTING ENGLISH PHRASAL VERBS

    Directory of Open Access Journals (Sweden)

    Éva Kovács

    2014-03-01

    Full Text Available Phrasal verbs or multi-word verbs, such as call off, go into and run up against, etc. represent a very interesting and challenging aspect of the English language. In ELT there is a widespread view that familiarity with a wide range of phrasal verbs and the ability to use them appropriately in context are among the distinguishing marks of a native-like command of English. However, it is also generally recognised that these verb+particle combinations pose special difficulties for both learners and teachers of English partly because there are so many of them, partly because they have special semantic, syntactic and stylistic properties. Besides, quite many of them can be used as nouns, e.g. a hideaway, a stowaway and a write-off, etc. and adjectives, e.g. a broken-down car and a knockdown price, etc. What is more, again quite many of them have a single word equivalent of Romance origin, which, however, often differs from them in terms of style, collocation and meaning, e.g. blow up ~ explode, do away with ~ eliminate and put out ~ extinguish, etc. Furthermore, it is a misconception that phrasal verbs are mainly used in informal style and in spoken English. In fact, they can be found in many styles of writing, ranging from highly formal texts to slang, e.g. call forth vs. gobble up, etc. This paper sets out to explore the unique and complex nature of English verb+particle constructions in order to make them a more manageable part of the vocabulary of English.

  17. Higher English for CFE

    CERN Document Server

    Bridges, Ann; Mitchell, John

    2015-01-01

    A brand new edition of the former Higher English: Close Reading , completely revised and updated for the new Higher element (Reading for Understanding, Analysis and Evaluation) - worth 30% of marks in the final exam!. We are working with SQA to secure endorsement for this title. Written by two highly experienced authors this book shows you how to practice for the Reading for Understanding, Analysis and Evaluation section of the new Higher English exam. This book introduces the terms and concepts that lie behind success and offers guidance on the interpretation of questions and targeting answer

  18. Gimson's pronunciation of English

    CERN Document Server

    Cruttenden, Alan

    2014-01-01

    Since its first publication in 1962, Gimson's Pronunciation of English has been the essential reference book for anyone studying or teaching the pronunciation of English.This eighth edition has been updated to describe General British (GB) as the principal accent, rather than RP, and the accompanying transcriptions have been brought into line with recent changes in pronunciation. This latest edition also includes completely rewritten chapters on the history of the language and the emergence of a standard, alongside a justification for the change from RP to GB.

  19. Telephoning in English

    CERN Document Server

    Naterop, B Jean

    1994-01-01

    Many people have to use English on the telephone in the course of their work, either at the level of taking a simple message or involving more complex tasks such as requesting information. Telephoning in English provides an up-to-date and relevant context in which students from lower-intermediate level upwards can develop practical telephone skills. The course principally develops spoken interactive skills, but also includes reading material on telephone systems and techniques. As the material is not restricted to particular job functions, it is suitable for students in a wide range of business and administration fields.

  20. Importance of English and Different Methods of Teaching English

    OpenAIRE

    Reddy, Dr. P. Sreenivasulu

    2013-01-01

    Todays world considers English as a global language. The present article explains how the teaching of English started with Grammar-Translation Method and secured a strong hold in the field of teaching English, though its basic assumptions were questionable. It also examines the principles of Direct Method and its insistence on establishing a bond between the experience and expression. In an effort to meet the needs of the Indian students of English, we learn that Michael West proposed the Rea...

  1. Teaching English to Engineers: Between English Language Teaching and Psychology

    OpenAIRE

    Irina-Ana Drobot

    2016-01-01

    Teaching English to Engineers is part of English for Specific Purposes, a domain which is under the attention of English students especially under the current conditions of finding jobs and establishing partnerships outside Romania. The paper will analyse the existing textbooks together with the teaching strategies they adopt. Teaching English to Engineering students can intersect with domains such as psychology and cultural studies in order to teach them efficiently. Textbooks for students o...

  2. Beginnings of the Industrial Revolution in England.

    Science.gov (United States)

    Scrofani, E. Robert, Ed.

    These teacher-developed materials are designed to help educators integrate economic concepts into the teaching of history. The materials include readings on the Industrial Revolution in England and a series of activities that require students to analyze the impact of industrialization first on English peasant farmers, and then on workers in early…

  3. Drug Facts

    Medline Plus

    Full Text Available ... Why Is It So Hard to Quit Drugs? Effects of Drugs Drug Use and Other People Drug ... Unborn Children Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug ...

  4. CDC Vital Signs: HIV and Injection Drug Use

    Science.gov (United States)

    ... Read the MMWR Science Clips HIV and Injection Drug Use Syringe Services Programs for HIV Prevention Language: English ( ... Pages Vital Signs Issue details: HIV and Injection Drug Use, Morbidity and Mortality Weekly Report (MMWR) Vital Signs – ...

  5. English Verb Accuracy of Bilingual Cantonese-English Preschoolers.

    Science.gov (United States)

    Rezzonico, Stefano; Goldberg, Ahuva; Milburn, Trelani; Belletti, Adriana; Girolametto, Luigi

    2017-07-26

    Knowledge of verb development in typically developing bilingual preschoolers may inform clinicians about verb accuracy rates during the 1st 2 years of English instruction. This study aimed to investigate tensed verb accuracy in 2 assessment contexts in 4- and 5-year-old Cantonese-English bilingual preschoolers. The sample included 47 Cantonese-English bilinguals enrolled in English preschools. Half of the children were in their 1st 4 months of English language exposure, and half had completed 1 year and 4 months of exposure to English. Data were obtained from the Test of Early Grammatical Impairment (Rice & Wexler, 2001) and from a narrative generated in English. By the 2nd year of formal exposure to English, children in the present study approximated 33% accuracy of tensed verbs in a formal testing context versus 61% in a narrative context. The use of the English verb BE approximated mastery. Predictors of English third-person singular verb accuracy were task, grade, English expressive vocabulary, and lemma frequency. Verb tense accuracy was low across both groups, but a precocious mastery of BE was observed. The results of the present study suggest that speech-language pathologists may consider, in addition to an elicitation task, evaluating the use of verbs during narratives in bilingual Cantonese-English bilingual children.

  6. Practices That Promote English Reading for English Learners (Els)

    Science.gov (United States)

    Martínez, Rebecca S.; Harris, Bryn; McClain, Maryellen Brunson

    2014-01-01

    Schools are becoming increasingly diversified; however, training and professional development related to working with English language learners (ELs), especially in the area of English reading, is limited. In this article, we identify three "Big Ideas" of effective and collaborative practices that promote English reading achievement for…

  7. Japanese College Students' Attitudes towards Japan English and American English

    Science.gov (United States)

    Sasayama, Shoko

    2013-01-01

    This study investigated contemporary Japanese college students' attitudes towards Japan English (JE) and American English (AE) through a verbal guise test (VGT) as well as a questionnaire. Forty-four Japanese college students listened to four Japanese and four North Americans reading a text in English, rated them in terms of solidarity-related…

  8. Why Do Primary School English Teachers Decide to Teach English?

    Science.gov (United States)

    Amengual-Pizarro, Marian; Garcia Laborda, Jesus

    2015-01-01

    This study is an attempt to explore the nature of L2 teachers' motivation towards English language learning and their decision to become English teachers. A total of 45 third-year prospective Primary school English teachers at the University of the Balearic Islands completed a small-scale survey adapted from Gardner's Attitude/Motivation Test…

  9. World Englishes, English as an International Language and Applied Linguistics

    Science.gov (United States)

    Kilickaya, Ferit

    2009-01-01

    The paper discusses World Englishes (WEs) in relation to English as an International Language (EIL) and Applied Linguistics. Taking into account Kachru's interesting but at the same time controversial debate about the status of English in its varieties, which are commonly called WEs and the opposing ideas presented by Quirk, it is aimed to present…

  10. On Differences between General English Teaching and Business English Teaching

    Science.gov (United States)

    Zhu, Wenzhong; Liao, Fang

    2008-01-01

    With the accelerating rate of globalization, business exchanges are carried out cross the border, as a result there is a growing demand for talents professional both in English and Business. We can see that at present Business English courses are offered by many language schools in the aim of meeting the need for Business English talent. Many…

  11. Breakthrough Drugs and Turtle Soup

    OpenAIRE

    Chabner, Bruce A.

    2015-01-01

    The U.S. Food and Drug Administration (FDA) category of Breakthrough Therapy drugs was established in 2012, fostered by collaboration between legislators, researchers, industry representatives, and cancer research advocates. This category allows the FDA to designate certain lifesaving drugs for expedited review, and it has been successful in speeding the approval of several new drugs.

  12. Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study.

    Science.gov (United States)

    Hughes, Shannon; Cohen, David; Jaggi, Rachel

    2014-07-09

    To examine the degree of concordance in reporting serious adverse events (SAEs) from antidepressant and antipsychotic drug trials among journal articles and clinical trial summaries, and to categorise types of discrepancies. Cross-sectional study of summaries of all antidepressant and antipsychotic trials included in an online trial registry and their first associated stand-alone journal articles. Clinicalstudyresults.org, sponsored by Pharmaceutical Research and Manufacturers of America; clinicaltrials.gov, administered by the US National Institutes of Health. 3 coders extracted data on the numbers and types of SAEs. 244 trial summaries for six antidepressant and antipsychotic drugs were retrieved, 142 (58.2%) listing an associated article. Of 1608 SAEs in drug-treated participants according to trial summaries, 694 (43.2%) did not appear in associated articles. Nearly 60% of SAEs counted in articles and 41% in trial summaries had no description. Most cases of death (62.3%) and suicide (53.3%) were not reported in articles. Half or more of the 142 pairs were discordant in reporting the number (49.3%) or description (67.6%) of SAEs. These discrepancies resulted from journal articles' (1) omission of complete SAE data, (2) reporting acute phase study results only and (3) more restrictive reporting criteria. Trial summaries with zero SAE were 2.35 (95% CI, 1.58 to 3.49; pjournal article. Since clinicalstudyresults.org was removed from the Internet in 2011, only 7.8% of retrieved trial summaries appear with results on clinicaltrials.gov. Substantial discrepancies exist in SAE data found in journal articles and registered summaries of antidepressant and antipsychotic drug trials. Two main scientific sources accessible to clinicians and researchers are limited by incomplete, ambiguous and inconsistent reporting. Access to complete and accurate data from clinical trials of drugs currently in use remains a pressing concern. Published by the BMJ Publishing Group Limited

  13. English II. Revised.

    Science.gov (United States)

    Spann, Margaret; And Others

    This manual is intended to enable academically disadvantaged and disabled youth to acquire basic communications and English skills while also acquiring a salable vocational skill. The following topics are covered in the individual units: related vocational information (abbreviations); related vocational skills (job search, job application forms,…

  14. HAIKU IN ENGLISH.

    Science.gov (United States)

    HENDERSON, HAROLD G.

    CONVENTIONS FOR CLASSICAL JAPANESE HAIKU USUALLY INCLUDE--17 JAPANESE SYLLABLES IN A 5-7-5 LINE PATTERN, AND SOME SPECIFIC REFERENCE TO AN ASPECT OF NATURE AND TO A PARTICULAR EVENT, PRESENTED AS IF IT WERE HAPPENING IN THE IMMEDIATE PRESENT TO ALLOW THE READER TO EXPERIENCE THE POET'S EMOTION. HAIKU IN ENGLISH, A FORM OF POETRY WHICH HAS BECOME…

  15. Choosing Tense in English.

    Science.gov (United States)

    1984-11-01

    Halliday) have emphasized deixis as a temporal as well as a spatial category. Halliday’s account of tense is the foundation for the present account...Longman, 1981. [Huddleston 69] Huddleston, R. Some Observations on Tense and Deixis in English. Language 45:777 - 806, 1969. [Hudson 76] Hudson, R. A

  16. English 3135: Visual Rhetoric

    Science.gov (United States)

    Gatta, Oriana

    2013-01-01

    As an advanced rhetoric and composition doctoral student, I taught Engl 3135: Visual Rhetoric, a three-credit upper-level course offered by the Department of English at Georgia State University. Mary E. Hocks originally designed this course in 2000 to, in her words, "introduce visual information design theories and practices for writers [and]…

  17. Dictionaries of Canadian English

    African Journals Online (AJOL)

    Information Technology

    John Considine, Department of English, University of Alberta,. Edmonton, Canada .... this sort of negative attention to it. Wordlists appeared sporadically, but on a very modest scale. So, for instance, Julian Moreton's Life and Work in Newfound- ..... sort of scale as the Dictionary of Americanisms on which Lovell had worked.

  18. English Leadership Quarterly, 1993.

    Science.gov (United States)

    Strickland, James, Ed.

    1993-01-01

    These four issues of the English Leadership Quarterly represent those published during 1993. Articles in number 1 deal with parent involvement and participation, and include: "Opening the Doors to Open House" (Jolene A. Borgese); "Parent/Teacher Conferences: Avoiding the Collision Course" (Robert Perrin); "Expanding Human…

  19. English-Cinyanja Dictionary.

    Science.gov (United States)

    Zambesi Mission, Mitsidi (Malawi).

    This English-Chinyanja (Cinyanja) dictionary was prepared and published by the Zambesi Mission for use in Africa. Compilers of this volume were aided by Africans of Southern Angoniland and a Yao tribesman from the Blantyre district knowledgeable in Chinyanja. Spelling rules used are those of the United Translation Board, which has adopted…

  20. Oxford English Dictionary

    African Journals Online (AJOL)

    and supremacist attitudes, which caused entries for words of this kind to be shorter and less detailed, and affected ... kinds should receive the same degree of attention, which implies that data collection from the reading of primary ... this paper, African languages have contributed a great many vocabulary items to the English ...

  1. Overcoming Fossilized English.

    Science.gov (United States)

    Graham, Janet G.

    Causes of language fossilization and ways to overcome it are considered. Fossilization is the relatively permanent incorporation of incorrect linguistic forms into a person's second language competence. The discussion is focused on fossilization of incorrect syntactical rules, based on experiences with learners of English as a second language at…

  2. Fostering English Learners' Confidence

    Science.gov (United States)

    Bondie, Rhonda; Gaughran, Laurie; Zusho, Akane

    2014-01-01

    A teacher is doing something right when his high school students--kids with limited English, no less--form groups and begin discussing a lesson on quadratic equations at the start of class, without any teacher direction. Bondie, Gaughran, and Zusho describe "discussion routines" that teachers at International Community High School in the…

  3. English Only JAMAS.

    Science.gov (United States)

    Cartagena, Juan

    1989-01-01

    Puerto Ricans have been largely ignored in the current debate over English as a national language. Once the rhetoric of language restrictionists is discarded, the real issue becomes that of the political empowerment of Puerto Ricans. The history of language policy in relation to Puerto Ricans is also reviewed. (SLD)

  4. English in Africa

    African Journals Online (AJOL)

    English in Africa is listed in the Journal of Commonwealth Literature Annual Bibliography, the Modern Language Association MLA International Bibliography, Institute for Scientific Information Arts and Humanities Citation Index, and accredited by the South African Department of Education. The journal has its own website at.

  5. Measuring Growth in English.

    Science.gov (United States)

    Diederich, Paul B.

    The monograph is a complete outline for a program designed to help English departments institute logical and fair procedures for grading student essays. The contents in this monograph include "Factors in Judgments of Writing Ability,""The Effect of Bias,""Measuring Improvement in Writing,""Personal vs Staff Grading,""Standard Scores for Test…

  6. English Language Teaching Through Literature : An Application of English Poetry in the High School English Textbook to the Classroom

    OpenAIRE

    濵口, 脩

    2004-01-01

    The aim of this present paper is to review the present state of English poetry in the high school English textbooks in Japan and to propose some practical application of English poems to the English language classroom. Several cases in which English poems are found in actual English high school textbooks are discussed, and then, since there seems to be no explanation of teaching English poems, with some notes of them and of reading English poems in general, some practical suggetions for impro...

  7. Standard English and Language Attitudes

    OpenAIRE

    ソランキ, ネイディン

    2005-01-01

    This paper investigates the attitudes and opinions surrounding Standard English (SE) within the United Kingdom. The definition of SE, for the purposes of this study, is standard grammar and standard pronunciation of southern English, commonly referred to as 'BBC English'. The subject of SE and attitudes towards different accents and dialects of British English is emotive and attracts strong opinions. The main issues discussed here are the place of language in society, the social implications ...

  8. Symposium: What Is College English?

    Science.gov (United States)

    Bloom, Lynn Z.; White, Edward M.; Enoch, Jessica; Hawk, Byron

    2013-01-01

    This symposium explores the role(s) College English has (or has not) had in the scholarly work of four scholars. Lynn Bloom explores the many ways College English influenced her work and the work of others throughout their scholarly lives. Edward M. White examines four articles he has published in College English and draws connections between…

  9. Brunei English: A Developing Variety

    Science.gov (United States)

    O'Hara-Davies, Breda

    2010-01-01

    A considerable amount of time has elapsed since the existence of a distinct variety of English, Brunei English (BNE), was mooted in the early 1990s. A subsequent study conducted by Svalberg in 1998 suggested that BNE was then in its infancy and that its speakers were largely unaware of the differences between it and Standard British English (STE).…

  10. Prescriptivism, Creativity, and World Englishes.

    Science.gov (United States)

    Bhatt, Rakesh M.

    1995-01-01

    Critiques the idea that standard British or American English is the only model for second language instruction, arguing that successful English language teaching in nonnative contexts, such as in India, must address the relationship between the forms that English manifests and its speakers' perception of reality and the nature of their cultural…

  11. The Zanzibar English Reading Programme.

    Science.gov (United States)

    Cunningham, Roger.

    1991-01-01

    The Zanzibar Ministry of Education instituted an English reading program into all secondary schools in 1989 to raise the levels of English teaching and learning (English being the medium of instruction and testing from secondary level and beyond). The program description and conclusions include implications for program design and implementation.…

  12. Chinese English Learners' Strategic Competence

    Science.gov (United States)

    Wang, Dianjian; Lai, Hongling; Leslie, Michael

    2015-01-01

    The present study aims to investigate Chinese English learners' ability to use communication strategies (CSs). The subjects are put in a relatively real English referential communication setting and the analyses of the research data show that Chinese English learners, when encountering problems in foreign language (FL) communication, are…

  13. English as an African Language.

    Science.gov (United States)

    Desai, Gaurav

    1993-01-01

    Discusses the role of the English language in postcolonial African literature, focusing on the politics of language, "Africanized" English, and the social languages used in Chinua Achebe's novels and concludes that English today is as much an African language as a British or American one. (Contains 37 references.) (MDM)

  14. Teachers' Habitus for Teaching English

    Science.gov (United States)

    Flynn, Naomi

    2015-01-01

    In this examination of monolingual and multilingual pedagogies I draw on literature that explores the position of English globally and in the curriculum for English. I amplify the discussion with data from a project exploring how teachers responded to the arrival of Polish children in their English classrooms following Poland's entry to the…

  15. English Language Teaching Profile: Cameroon.

    Science.gov (United States)

    British Council, London (England). English-Teaching Information Centre.

    This is a summary in outline form of the English language teaching situation in Cameroon. Cameroon is officially a French/English bilingual state but English at present plays the minor part. There are five francophone and two anglophone provinces with populations of five million and one and a half million respectively. In the anglophone provinces…

  16. Intercultural Processes in Accented English

    Science.gov (United States)

    Rivers, Damian J.

    2011-01-01

    This study assessed the attitudinal responses of 48 Japanese university students towards 10 accented English speech samples across nine evaluative criteria. Of the 10 samples, one was a Japanese-English speech sample (the intracultural familiar), seven were non-native-English samples originating from a variety of Asian countries (intercultural…

  17. The Passive in Singapore English.

    Science.gov (United States)

    Bao, Zhiming; Wee, Lionel

    1999-01-01

    Presents an analysis of the two passive (or passive-like) constructions in Singapore English which exhibit substrate influence from Malay and Chinese. The paper shows that while substrate languages contribute to the grammar of Singapore English, the continued prestige of standard English exerts normative pressure and mitigates the effect of…

  18. Correct English for Modern Needs.

    Science.gov (United States)

    Pooley, Robert C.

    1995-01-01

    Reprints an article originally published in 1932. Discusses the development of S. Leonard's book "Current English Usage." Suggests that the monograph stands as a symbol of a spirit and attitude in the teaching of English which will have far-reaching influence in determining the course of study and content of English instruction in the future. (RS)

  19. Environmental pollution with antimicrobial agents from bulk drug manufacturing industries in Hyderabad, South India, is associated with dissemination of extended-spectrum beta-lactamase and carbapenemase-producing pathogens.

    Science.gov (United States)

    Lübbert, Christoph; Baars, Christian; Dayakar, Anil; Lippmann, Norman; Rodloff, Arne C; Kinzig, Martina; Sörgel, Fritz

    2017-08-01

    High antibiotic and antifungal concentrations in wastewater from anti-infective drug production may exert selection pressure for multidrug-resistant (MDR) pathogens. We investigated the environmental presence of active pharmaceutical ingredients and their association with MDR Gram-negative bacteria in Hyderabad, South India, a major production area for the global bulk drug market. From Nov 19 to 28, 2016, water samples were collected from the direct environment of bulk drug manufacturing facilities, the vicinity of two sewage treatment plants, the Musi River, and habitats in Hyderabad and nearby villages. Samples were analyzed for 25 anti-infective pharmaceuticals with liquid chromatography-tandem mass spectrometry and for MDR Gram-negative bacteria using chromogenic culture media. In addition, specimens were screened with PCR for bla VIM , bla KPC , bla NDM , bla IMP-1 , and bla OXA-48 resistance genes. All environmental specimens from 28 different sampling sites were contaminated with antimicrobials. High concentrations of moxifloxacin, voriconazole, and fluconazole (up to 694.1, 2500, and 236,950 µg/L, respectively) as well as increased concentrations of eight other antibiotics were found in sewers in the Patancheru-Bollaram industrial area. Corresponding microbiological analyses revealed an extensive presence of extended-spectrum beta-lactamase and carbapenemase-producing Enterobacteriaceae and non-fermenters (carrying mainly bla OXA-48 , bla NDM , and bla KPC ) in more than 95% of the samples. Insufficient wastewater management by bulk drug manufacturing facilities leads to unprecedented contamination of water resources with antimicrobial pharmaceuticals, which seems to be associated with the selection and dissemination of carbapenemase-producing pathogens. The development and global spread of antimicrobial resistance present a major challenge for pharmaceutical producers and regulatory agencies.

  20. Towards a corpus of South African English: corralling the sub-varieties

    African Journals Online (AJOL)

    Riette Ruthven

    lish Corpus, the New Zealand Corpus of Spoken English and the Hong Kong Corpus of Conversa- tional English. The various .... government, education, commerce, industry and in the media. Linguistic research into ..... Casual conver- sation has also been described as the quintessence of language, a kind of 'pre- genre' in ...

  1. A.P. Cowie (Editor). The Oxford History of English Lexicography ...

    African Journals Online (AJOL)

    Riette Ruthven

    According to the blurb, The Oxford History of English Lexicography (volumes I–II) presents 'the fullest account yet published of the lexicography of English from its origins in medieval glosses, through its rapid development in the eighteenth century, to a fully-established high-tech industry that is as reliant as ever on learning ...

  2. The robustness of reindeer husbandry – need for a new approach to elucidate opportunities and sustainability of the reindeer industry in its socio-ecological context (In Swedish with Summary in English

    Directory of Open Access Journals (Sweden)

    Öje Danell

    2005-04-01

    Full Text Available A series of transformations and adaptations in the Sami use of land for their subsistence over a long period of time has led to the reindeer husbandry of today. In Sweden the Sami rights to land and water are today legally connected to the practising of reindeer husbandry as a livelihood. Together with a few associated commodities, it has become considered is the only lasting Sami land-use. In the Sami culture, a central element is the association of the people with the land and the subsistence on what is provided in nature. Consequently, this association between people and land is today kept alive by the reindeer husbandry practiced as a livelihood, which thereby also produces and manages an essential base for the culture. The developments in the surrounding society are currently reducing the latitude for the reindeer industry at an accelerated rate and thereby also its capacity to handle new situations. In the complicated ecological, economic, social and institutional contexts, where reindeer husbandry is practiced, there is a large risks for sudden and unpredicted disintegrations and collapses at different system levels. The consequences thereof for the long term continuation and adaptability of Sami land use are largely unpredictable. If it leads to a collapse of reindeer industry as mode of land-use, the risks of additional deterioration of the Sami indigenous rights is also apparent and thereby the scope for new solutions as well. This will likely have serious negative consequences for the viability of the Sami culture concurrently with declining live dependences of the land. The situation of reindeer husbandry has similarities with management crises in many other integrated socio-ecological systems, which have led to sustainability failures and unpredicted consequences. These insights seem to be deficient in the treatment of the problems, which reindeer industry is facing. Scientists could probably make a very important contribution by

  3. Attitudes towards English in Ghana

    Directory of Open Access Journals (Sweden)

    Kari Dako

    2017-05-01

    Full Text Available The paper considers official and individual attitudes towards bilingualism in English and a Ghanaian language. We ask whether bilingualism in English and Ghanaian languages is a social handicap, without merit, or an important indicator of ethnic identity. Ghana has about 50 non-mutually intelligible languages, yet there are no statistics on who speaks what language(s where in the country. We consider attitudes to English against the current Ghanaian language policy in education as practised in the school system. Our data reveal that parents believe early exposure to English enhances academic performance; English is therefore becoming the language of the home.

  4. Reconsidering English Grammar Teaching for Improving Non-English Majors' English Writing Ability

    Science.gov (United States)

    Shen, Yuru

    2012-01-01

    With the globalization of world economy, English learners' writing ability has been attached less and less importance. As a result, many college students in China, especially the non-English majors, cannot express themselves effectively in written English. They make various kinds of mistakes, mostly grammar mistakes, such as writing sentence…

  5. Industry Employment

    Science.gov (United States)

    Occupational Outlook Quarterly, 2012

    2012-01-01

    This article illustrates projected employment change by industry and industry sector over 2010-20 decade. Workers are grouped into an industry according to the type of good produced or service provided by the establishment for which they work. Industry employment projections are shown in terms of numeric change (growth or decline in the total…

  6. Drug Facts

    Medline Plus

    Full Text Available ... Facts Search form Search Menu Home Drugs That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, ... Drugs? Effects of Drugs Drug Use and Other People Drug Use and Families Drug Use and Kids ...

  7. Drug Facts

    Medline Plus

    Full Text Available ... Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard to Quit Drugs? ... Drug Use and Other People Drug Use and Families Drug Use and Kids Drug Use and Unborn ...

  8. Drug Facts

    Medline Plus

    Full Text Available ... People Drug Use and Families Drug Use and Kids Drug Use and Unborn Children Drug Use and ... Children and Teens Stay Drug-Free Talking to Kids About Drugs: What to Say if You Used ...

  9. The Cutting Edge: Workplace English. Section I: Project Handbook.

    Science.gov (United States)

    El Paso Community Coll., TX. Literacy Center.

    A model workplace literacy program of El Paso Community College (Texas), in cooperation with Levi Strauss and Company, is described. The partnership designed a three-part, job-specific, video-based curriculum in English as a Second Language (ESL) for garment industry workers, implemented in seven local plants. The 18-month program had these goals:…

  10. The Prison Industrial Complex

    OpenAIRE

    Earl Smith; Angela Hattery

    2006-01-01

    Incarceration has become a multi-billion dollar industry that relies on more than 2 million citizens on any give day in the United States. African American males, who in the 1970s were only 9% of the prison population, after harsher sentencing largely fueled by the drug trade, are now 62% of the prison population. This is viewed as a national tragedy.

  11. Industry sponsorship and research outcome

    DEFF Research Database (Denmark)

    Lundh, Andreas; Sismondo, Sergio; Lexchin, Joel

    2012-01-01

    Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical industry sponsored studies are more often favorable to the sponsor's product compared with studies...

  12. Language Training: English

    CERN Multimedia

    Françoise benz

    2005-01-01

    Oral Expression The next session will take place from January to March 2005. This course is intended for people with a good knowledge of English who want to practise and maintain their speaking skills while extending their vocabulary. There will be a maximum of 10 participants in a class. Speaking activities will include discussions, meeting simulations, role-plays etc. depending on the needs of the students. Timetable: Tuesday 11.30 to 13.30 Duration: 20 hours Price: 440 CHF (for a minimum of 8 students) Writing Professional Documents in English The next session will take place from January to March 2005. This course is designed for people with a good level of spoken English. Duration: 20 hours Price: 440 CHF (for 8 students) Timetable will be fixed after discussion with the students. For registration and further information on these courses, please consult our Web pages: http://cern.ch/Training or contact Mrs. Benz: Tel. 73127. FORMATION EN LANGUES LANGUAGE TRAINING Françoise Benz 73127 langu...

  13. Language Training: English

    CERN Multimedia

    Françoise Benz

    2004-01-01

    Oral Expression The next session will take place from January to March 2005. This course is intended for people with a good knowledge of English who want to practise and maintain their speaking skills while extending their vocabulary. There will be a maximum of 10 participants in a class. Speaking activities will include discussions, meeting simulations, role-plays etc. depending on the needs of the students. Timetable: Tuesday 11.30 to 13.30 Duration: 20 hours Price: 440 CHF (for a minimum of 8 students) Writing Professional Documents in English The next session will take place from January to March 2005. This course is designed for people with a good level of spoken English. Duration: 20 hours Price: 440 CHF (for 8 students) Timetable will be fixed after discussion with the students. For registration and further information on these courses, please consult our Web pages: http://cern.ch/Training or contact Mrs. Benz: Tel. 73127. FORMATION EN LANGUES LANGUAGE TRAINING Françoise Benz 73127 langua...

  14. Language Training: English Courses

    CERN Multimedia

    Françoise Benz

    2005-01-01

    General and Professional English Courses The next session will take place from 28 February to 24 June 2005 (2/3 weeks break at Easter). These courses are open to all persons working on the CERN site, and to their spouses. For registration and further information on the courses, please consult our Web pages: http://cern.ch/Training or contact Mr. Liptow: tel. 72957. Oral Expression The next session will take place from March to June 2005. This course is intended for people with a good knowledge of English who want to practise and maintain their speaking skills while extending their vocabulary. There will be a maximum of 10 participants in a class. Speaking activities will include discussions, meeting simulations, role-plays etc. depending on the needs of the students. Duration: 20 hours Price: 440 CHF (for a minimum of 8 students) Timetable will be fixed after discussion with the students. Writing Professional Documents in English The next session will take place from March to June 2005. T...

  15. Language Training: English Courses

    CERN Multimedia

    Françoise Benz

    2005-01-01

    General and Professional English Courses The next session will take place from 28 February to 24 June 2005 (2/3 weeks break at Easter). These courses are open to all persons working on the CERN site, and to their spouses. For registration and further information on the courses, please consult our Web pages: http://cern.ch/Training or contact Mr. Liptow: tel. 72957. Oral Expression The next session will take place from March to June 2005. This course is intended for people with a good knowledge of English who want to practise and maintain their speaking skills while extending their vocabulary. There will be a maximum of 10 participants in a class. Speaking activities will include discussions, meeting simulations, role-plays etc. depending on the needs of the students. Duration: 20 hours Price: 440 CHF (for a minimum of 8 students) Timetable will be fixed after discussion with the students. Writing Professional Documents in English The next session will take place from March to June 2005. Th...

  16. Language Training - English Training

    CERN Multimedia

    HR Department

    2009-01-01

    General and Professional English Courses The next session will take place: from 2nd March to end of June 2009 (1/2 weeks break at Easter). These courses are open to all persons working on the CERN site, and to their spouses. For registration and further information on the courses, please consult our Web pages: http://cern.ch/Training or contact Nathalie Dumeaux, tel. 78144. Oral Expression The next session will take place from 2nd March to end of June 2009 (1/2 weeks break at Easter). This course is intended for people with a good knowledge of English who want to enhance their speaking skills. There will be on average of 8 participants in a class. Speaking activities will include discussions, meeting simulations, role-plays etc. depending on the needs of the students. Duration: 30 hours Price: 660 CHF (for a minimum of 8 students) Writing Professional Documents in English The next session will take place from 2nd March to end of June 2009 (1/2 weeks break at Easter). This course is designed for people w...

  17. Language Training - English Training

    CERN Multimedia

    HR Department

    2009-01-01

    General and Professional English Courses The next session will take place: from 2nd March to end of June 2009 (1/2 weeks break at Easter). These courses are open to all persons working on the CERN site, and to their spouses. For registration and further information on the courses, please consult our Web pages: http://cern.ch/Training or contact Nathalie Dumeaux, tel. 78144. Oral Expression The next session will take place from 2nd March to end of June 2009 (1/2 weeks break at Easter). This course is intended for people with a good knowledge of English who want to enhance their speaking skills. There will be an average of 8 participants per class. Speaking activities will include discussions, meeting simulations, role-plays, etc., depending on the needs of the students. Duration: 30 hours Price: 660 CHF (for a minimum of 8 students) Writing Professional Documents in English The next session will take place from 2nd March to end of June 2009 (1/2 weeks break at Easter). This course is designed for people ...

  18. Method for manufacturing carrier containing e.g. proteins for human during oral drug delivery operation for food and drug administration application in pharmaceutical industry, involves providing active ingredient to core layer

    DEFF Research Database (Denmark)

    2015-01-01

    or plastically deformable layer to increase stiction of the release layer. The method enables manufacturing the micro-container including an outer diameter of 200-500 pm and a height of 2-70 pm such that wall thickness is larger than 5 m to increase geometrical stability and reduce buckling. The method enables...... of the micro-containers containing an active ingredient or containing a core layer that is configured to accept the active ingredient such that the barrier layer partially encloses the core layer. The active ingredient is provided to the core layer when the core layer is configured to accept the active...... ingredient. USE - Method for manufacturing a multi-layered micro-container i.e. carrier, containing an active ingredient e.g. small organic molecules, proteins, peptides, vitamins, antibodies, antibody fragments, vaccines, RNA, DNA and antibiotics, for a patient e.g. human and animal, during an oral drug...

  19. Dictionaries of Canadian English

    Directory of Open Access Journals (Sweden)

    John Considine

    2011-10-01

    Full Text Available

    Abstract: The lexicographical record of English in Canada began with wordlists of the late eighteenth, nineteenth, and early twentieth centuries. From the beginning of the twentieth century onwards, the general vocabulary of English in Canada has been represented in bilingual and monolingual dictionaries, often adapted from American or British dictionaries. In the 1950s, several important projects were initiated, resulting in the publication of general dictionaries of English in Canada, and of dictionaries of Canadianisms and of the vocabulary of particular regions of Can-ada. This article gives an overview of these dictionaries and of their reception, contextualizing them in the larger picture of the lexicography of Canada's other official language, French, and of a number of its non-official languages. It concludes by looking at the future of English-language lexicography in Canada, and by observing that although it has, at its best, reached a high degree of sophistication, there are still major opportunities waiting to be taken.

    Keywords: DICTIONARY, LEXICOGRAPHY, CANADIAN ENGLISH, CANADIANISMS, NATIONAL DICTIONARIES, CANADIAN FRENCH, CANADIAN FIRST NATIONS LAN-GUAGES, BILINGUAL DICTIONARIES, REGIONAL DICTIONARIES, UNFINISHED DICTIONARY PROJECTS

    Opsomming: Woordeboeke van Kanadese Engels. Die leksikografiese optekening van Engels in Kanada begin met woordelyste van die laat agtiende, neëntiende en vroeë twintigste eeue. Van die begin van die twintigste eeu af en verder, is die algemene woordeskat van Engels weergegee in tweetalige en eentalige woordeboeke, dikwels met wysiginge ontleen aan Ameri-kaanse en Britse woordeboeke. In die 1950's is verskeie belangrike projekte onderneem wat gelei het tot die publikasie van algemene woordeboeke van Engels in Kanada, en van woordeboeke van Kanadeïsmes en van die woordeskat van bepaalde streke van Kanada. Hierdie artikel gee 'n oorsig van dié woordeboeke, en van hul ontvangs, deur

  20. ESL for Hotel/Hospitality Industry. Level: Advanced Beginner/Intermediate.

    Science.gov (United States)

    Western Suffolk County Board of Cooperative Educational Services, Northport, NY.

    This document contains 16 lesson plans for an advanced beginning and intermediate course in work-related English for non-English- or limited-English-speaking entry-level employees in the hotel and hospitality industry. Course objectives are as follows: helping participants understand and use job-specific vocabulary; receive and understand…

  1. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Science.gov (United States)

    2013-06-05

    ... No. FDA-2013-D-0589] Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs...

  2. Safe Drug Handling In Medical Facilities.

    OpenAIRE

    MUSILOVÁ, Marie

    2011-01-01

    Translation Czech ? English Abstract: Safe Drug Handling in Medical Facilities The issue of safety in drug handling in medical facilities creates a significant priority in maintaining and increasing the quality of care. The presented bachelor?s work deals with such problems both in theoretical and practical level. In the theoretical part it explains the methods of safe drug handling in all levels of that process, starting from the delivery of drugs from the hospital?s pharmacy, till their liq...

  3. Broadening the perspectives of South African English and Afrikaans ...

    African Journals Online (AJOL)

    colored english, caribbean dutch, counting-out rimes, diglossia, dutch, english, ethnolects, etymology, family names, french, german, jewish afrikaans, jewish american english, jewish british english, jewish english, jewish irish english, jewish ...

  4. Industrial Engineering

    DEFF Research Database (Denmark)

    Karlsson, Christer

    2015-01-01

    Industrial engineering is a discipline that is concerned with increasing the effectiveness of (primarily) manufacturing and (occasionally).......Industrial engineering is a discipline that is concerned with increasing the effectiveness of (primarily) manufacturing and (occasionally)....

  5. English for common entrance

    CERN Document Server

    Kossuth, Kornel

    2013-01-01

    Succeed in the exam with this revision guide, designed specifically for the brand new Common Entrance English syllabus. It breaks down the content into manageable and straightforward chunks with easy-to-use, step-by-step instructions that should take away the fear of CE and guide you through all aspects of the exam. - Gives you step-by-step guidance on how to recognise various types of comprehension questions and answer them. - Shows you how to write creatively as well as for a purpose for the section B questions. - Reinforces and consolidates learning with tips, guidance and exercises through

  6. Industrial recovery capability. Final report

    International Nuclear Information System (INIS)

    Gregg, D.W.

    1984-12-01

    This report provides an evaluation of the vulnerability - to a nuclear strike, terrorist attack, or natural disaster - of our national capacity to produce chlorine, beryllium, and a particular specialty alumina catalyst required for the production of sulfur. All of these industries are of critical importance to the United States economy. Other industries that were examined and found not to be particularly vulnerable are medicinal drugs and silicon wafers for electronics. Thus, only the three more vulnerable industries are addressed in this report

  7. Industrial symbiosis

    DEFF Research Database (Denmark)

    Sacchi, Romain; Remmen, Arne

    2017-01-01

    This study examines the development of industrial symbiosis through a practical model for physical, organizational, and social interactions in six different cases from around the world. The results provide a framework that can be used by industrial symbiosis practitioners to facilitate the creation...... of synergy in industrial areas....

  8. A communicative grammar of English

    CERN Document Server

    Leech, Geoffrey

    2013-01-01

    A Communicative Grammar of English has long been established as a grammar innovative in approach, reliable in coverage, and clear in its explanations. This fully revised and redesigned third edition provides up-to-date and accessible help to teachers, advanced learners and undergraduate students of English. Part One looks at the way English grammar varies in different types of English, such as 'formal' and 'informal', 'spoken' and 'written'; Part Two focuses on the uses of grammar rather than on grammatical structure and Part Three provides a handy alphabetically arranged guide to

  9. Meaning and the English verb

    CERN Document Server

    Leech, Geoffrey

    2014-01-01

    Every language has its peculiar problems of meaning for the foreign learner. In the English language, some of the biggest yet most fascinating problems are concentrated in the area of the finite verb phrase: in particular, tense, aspect, mood and modality. Meaning and the English Verb describes these fields in detail for teachers and advanced students of English as a foreign or second language. This new third edition uses up-to-date examples to show differences and similarities between American and British english, reflecting a great deal of recent research in this area. It also takes account

  10. GLOBALIZATION, ANGLICISMS AND BUSINESS ENGLISH

    OpenAIRE

    Pop Anamaria-Mirabela; Sim Monica-Ariana

    2015-01-01

    For a long time, people have felt the need for a common language in order to communicate faster and better and English has become the global language, spreading across the world. Nowadays, more and more people learn and speak English for different reasons. The effect of it is that English started influencing the native languages of the speakers who use a great variety of words and expressions from English while speaking their respective languages. The aim of this paper is to analyze the influ...

  11. Drug Addiction

    Science.gov (United States)

    ... attempt to stop taking the drug Recognizing unhealthy drug use in family members Sometimes it's difficult to ... sold to support drug use Recognizing signs of drug use or intoxication Signs and symptoms of drug ...

  12. Drug Allergy

    Science.gov (United States)

    ... Seizure Loss of consciousness Other conditions resulting from drug allergy Less common drug allergy reactions occur days ... reaction the first time you take the drug. Drugs commonly linked to allergies Although any drug can ...

  13. AP English language & composition

    CERN Document Server

    Bureau, Susan; Allen, John; Nesselrode, Katherine A; McGauley, Kristi R; Nesselrode, Katherine A; McGauley, Kristi R

    2013-01-01

    All Access for the AP® English Language and Composition Exam Book + Web + Mobile Everything you need to prepare for the Advanced Placement® exam, in a study system built around you! There are many different ways to prepare for an Advanced Placement® exam. What's best for you depends on how much time you have to study and how comfortable you are with the subject matter. To score your highest, you need a system that can be customized to fit you: your schedule, your learning style, and your current level of knowledge. This book, and the online tools that come with it, will help you personalize your AP® English Language and Composition prep by testing your understanding, pinpointing your weaknesses, and delivering flashcard study materials unique to you. The REA AP® All Access system allows you to create a personalized study plan through three simple steps: targeted review of exam content, assessment of your knowledge, and focused study in the topics where you need the most help. Here's how it works: Review ...

  14. Language Training: English Training

    CERN Multimedia

    Françoise Benz

    2004-01-01

    General and Professional English Courses The next session will take place from 04 October 2004 to 11 February 2005 (3 weeks break at Christmas). These courses are open to all persons working on the CERN site, and to their spouses. For registration and further information on the courses, please consult our Web pages: http://cern.ch/Training or contact Mr. Liptow, tel. 72957. Oral Expression This course is intended for people with a good knowledge of English who want to practise and maintain their speaking skills while extending their vocabulary. There will be approximately 8 participants in a class. Speaking activities will include discussions, meeting simulations, role-plays etc. depending on the needs of the students. Duration: 20 hours (2 hours a week) Price: 440 CHF (for 8 students) For further information, please contact Mr. Liptow, tel. 72957. Date and timetable will be fixed when there are sufficient participants enrolled. FORMATION EN LANGUES LANGUAGE TRAINING Françoise Benz 73127 langua...

  15. Language Training: English

    CERN Multimedia

    Françoise Benz

    2005-01-01

    If you wish to participate in one of the following courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at: http://www.cern.ch/Training/ or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. Oral Expression The next session will take place from January to March 2005. This course is intended for people with a good knowledge of English who want to practise and maintain their speaking skills while extending their vocabulary. There will be a maximum of 10 participants in a class. Speaking activities will include discussions, meeting simulations, role-plays etc. depending on the needs of the students. Timetable: Tuesday 11.30 to 13.30 Duration: 20 hours Price: 440 CHF (for a minimum of 8 students) Writing Professional Documents in English The next session will take place from Januar...

  16. Language Training: English Training

    CERN Multimedia

    Françoise Benz

    2004-01-01

    La prochaine session se déroulera du 04 octobre 2004 au 11 février 2005 (interruption de 3 semaines à Noël). Ces cours s'adressent à toute personne travaillant au CERN ainsi qu'à leur conjoint. Pour vous inscrire et voir tout le détail des cours proposés, consultez nos pages Web : http://cern.ch/Training Vous pouvez aussi contacter M. Liptow, tél. 72957. General and Professional English Courses The next session will take place from 04 October 2004 to 11 February 2005 (3 weeks break at Christmas). These courses are open to all persons working on the CERN site, and to their spouses. For registration and further information on the courses, please consult our Web pages: http://cern.ch/Training or contact Mr. Liptow, tel. 72957. Oral Expression This course is intended for people with a good knowledge of English who want to practise and maintain their speaking skills while extending their vocabulary. There will be approximately 8 participants ...

  17. Language Training: English Training

    CERN Multimedia

    Françoise Benz

    2004-01-01

    If you wish to participate in one of the following courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at: http://www.cern.ch/Training/ or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. General and Professional English Courses The next session will take place from 04 October 2004 to 11 February 2005 (3 weeks break at Christmas). These courses are open to all persons working on the CERN site, and to their spouses. For registration and further information on the courses, please consult our Web pages: http://cern.ch/Training or contact Mr. Liptow, tel. 72957. Oral Expression This course is intended for people with a good knowledge of English who want to practise and maintain their speaking skills while extending their vocabulary. There will be approximately 8 participants in...

  18. Language Training: English Training

    CERN Multimedia

    Françoise Benz

    2004-01-01

    General and Professional English Courses The next session will take place from 04 October 2004 to 11 February 2005 (3 weeks break at Christmas). These courses are open to all persons working on the CERN site, and to their spouses. For registration and further information on the courses, please consult our Web pages: http://cern.ch/Training or contact Mr. Liptow, tel. 72957. Oral Expression This course is intended for people with a good knowledge of English who want to practise and maintain their speaking skills while extending their vocabulary. There will be approximately 8 participants in a class. Speaking activities will include discussions, meeting simulations, role-plays etc. depending on the needs of the students. Duration: 20 hours (2 hours a week) Price: 440 CHF (for 8 students) For further information, please contact Mr. Liptow, tel. 72957. Date and timetable will be fixed when there are sufficient participants enrolled. FORMATION EN LANGUES LANGUAGE TRAINING Françoise Benz 73127 languag...

  19. English and French courses

    CERN Document Server

    2014-01-01

    If one of your New Year’s resolutions is to learn a language, there is no excuse anymore!   You can attend one of our English or French courses and you can practise the language with a tandem partner! Cours d’anglais général et professionnel La prochaine session se déroulera du 3 mars au 27 juin 2014. Ces cours s’adressent à toute personne travaillant au CERN ainsi qu’à leur conjoint. Pour vous inscrire et voir tout le détail des cours proposés, consultez nos pages web : http://cern.ch/Training. Oral Expression The next session will take place from 3 March to 27 June 2014. This course is intended for people with a good knowledge of English who want to enhance their speaking skills. There will be an average of 8 participants in a class. Speaking activities will include discussions, meeting simulations, role-plays etc. depending on the needs of the students. Writing Profe...

  20. English Book Club

    CERN Multimedia

    English Book Club

    The minutes of the AGM held on Tuesday November 17th can now be found on the club web-site: http://club-englishbookclub.web.cern.ch. A new version of the club’s book data-base is also available on the web: http://club-englishbookclub.web.cern.ch/club-englishbookclub/Export/index.html The last book selection for 2009 is done and the order for the new books has been placed, with luck they will be on the shelves before the end of year break. The English Book Club has a growing collection of over 4500 English language books, mostly general fiction with a sprinkling of nonfiction and children’s books. New books are purchased regularly and the books are shelved in our club room which is accessible to members at all times. Membership is open to all (staff and external) and there is a special tariff for short term students. See the club’s website at http://cern.ch/englishbookclub for more details.

  1. ENGLISH BOOK CLUB

    CERN Multimedia

    English Book Club

    2009-01-01

    http://club-englishbookclub.web.cern.ch A note to our members Dear Members, Many thanks to all of you who have paid up now. However, there are still some late payers and Morna would appreciate knowing if they will pay for 2009/2010 or if they have left the club. At the AGM on 17 November it was decided that a 3 month delay for key reimbursement will be given to all present and past members, BUT after 31.3.2010 no reimbursement will be given out. We are in the process of making changes to the access to the club for paid-up, active members only. Some of you have told Morna you will pay on your next visit to CERN, that is ok but please try to do this by 15 December if possible. A new version of the club’s book data-base is available on the web: http://club-englishbookclub.web.cern.ch/club-englishbookclub/Export/index.html The English Book Club has a growing collection of over 4500 English language books, mostly general fiction with a sprinkling of nonfiction and children’s books. New books...

  2. Industrial electrification

    International Nuclear Information System (INIS)

    Melvin, J.G.

    1983-03-01

    The technical and economic scope for industrial process electrification in Canada is assessed in the light of increasing costs of combustion fuels relative to electricity. It is concluded that electricity is capable of providing an increasing share of industrial energy, eventually aproaching 100 percent. The relatively low cost of electricity in Canada offers industry the opportunity of a head start in process electrification with consequent advantages in world markets both for industrial products and for electrical process equipment and technology. A method is described to promote the necessary innovation by providing access to technology and financing. The potential growth of electricity demand due to industrial electrification is estimated

  3. Homework Practices of English and Non-English-Speaking Parents

    Science.gov (United States)

    Thelamour, Barbara; Jacobs, D'Andrea L.

    2014-01-01

    This study compared the homework practices of English-speaking and non-English-speaking parents. Using a national data set of 7,992 students across ages and ethnicities, the frequency and type of homework practices were investigated. Statistical analysis revealed significant (though small) differences between the overall homework practices between…

  4. Botswana English: Implications for English Language Teaching and Assessment

    Science.gov (United States)

    Alimi, Modupe

    2011-01-01

    Concerted efforts to characterise Botswana English (BE), though still referred to as "a variety in development", have validated its existence. However, the teaching and assessment of English in the high schools do not seem to have responded to the development of this variety. This paper discusses the viability of using Standard British…

  5. Non-Native English Varieties: Thainess in English Narratives

    Science.gov (United States)

    Singhasak, Piyahathai; Methitham, Phongsakorn

    2016-01-01

    This study aims at examining Thainess as a writing strategy used in non-literary texts written by non-professional bilingual writers. These writers are advanced language learners who are pursuing their Master's degree in English. Seven English narratives of their language learning experiences were analyzed based on Kachruvian's framework of…

  6. Subclassification of English Adjectives for French to English Machine Translation.

    Science.gov (United States)

    Flanagan, Mary A.

    1990-01-01

    Advances the hypothesis that, when translating French personal constructions involving an adjective and a verb infinitive into English, the property of the English adjective determines whether the verb will be translated as an infinitive or as a gerund. Alternatives for handling such translations in machine translation systems are explored. (five…

  7. Orientations towards English among English-Medium Instruction Students

    Science.gov (United States)

    Karakas, Ali

    2015-01-01

    Based on the empirical data of my PhD research, this paper analyses the perceptions of 351 undergraduate students enrolled at English-medium universities towards English in terms of the language ideology framework. The students were purposively sampled from three programs at three Turkish universities. The data were drawn from student opinion…

  8. English Verb Accuracy of Bilingual Cantonese-English Preschoolers

    Science.gov (United States)

    Rezzonico, Stefano; Goldberg, Ahuva; Milburn, Trelani; Belletti, Adriana; Girolametto, Luigi

    2017-01-01

    Purpose: Knowledge of verb development in typically developing bilingual preschoolers may inform clinicians about verb accuracy rates during the 1st 2 years of English instruction. This study aimed to investigate tensed verb accuracy in 2 assessment contexts in 4- and 5-year-old Cantonese-English bilingual preschoolers. Method: The sample included…

  9. Perception of English palatal codas by Korean speakers of English

    Science.gov (United States)

    Yeon, Sang-Hee

    2003-04-01

    This study aimed at looking at perception of English palatal codas by Korean speakers of English to determine if perception problems are the source of production problems. In particular, first, this study looked at the possible first language effect on the perception of English palatal codas. Second, a possible perceptual source of vowel epenthesis after English palatal codas was investigated. In addition, individual factors, such as length of residence, TOEFL score, gender and academic status, were compared to determine if those affected the varying degree of the perception accuracy. Eleven adult Korean speakers of English as well as three native speakers of English participated in the study. Three sets of a perception test including identification of minimally different English pseudo- or real words were carried out. The results showed that, first, the Korean speakers perceived the English codas significantly worse than the Americans. Second, the study supported the idea that Koreans perceived an extra /i/ after the final affricates due to final release. Finally, none of the individual factors explained the varying degree of the perceptional accuracy. In particular, TOEFL scores and the perception test scores did not have any statistically significant association.

  10. An Introduction to English Teaching, A Textbook for English Educators

    Science.gov (United States)

    Lin, Grace Hui Chin; Chien, Paul Shih-chieh

    2010-01-01

    Teaching English became a professional and academic field from a half century ago. Many researches for teacher education and teacher training have been conducted in order to raise the English as well as the foreign language trainers' knowledge and capabilities in carrying out effective lessons in classroom. During second millennium of speedily…

  11. Axiological Role of English Adjectives in English Language Teaching

    Science.gov (United States)

    Zerkina, Natalya N.; Kostina, Nataliia N.; Urazayeva, Nailya R.; Lomakina, Yekaterina A.; Emets, Tatiana V.; Gallyamova, Maria S.; Melnikova, Elena P.; Trutnev, Alexey Yu.; Lukina, Oksana A.

    2016-01-01

    The article focuses on peculiarities of English adjective teaching as one of main and important lexicological basis. As the English language nowadays is important and universal as a native language of worldwide society, exactly that's why process of learning must include wide range of techniques not only as a process of learning theories but also…

  12. Perception of "English" and Motivation in Learning English

    Science.gov (United States)

    Sahin, Mehmet; Seçer, Sule Y. E.; Erisen, Yavuz

    2016-01-01

    This study aims to present high school students' perception of "English" through the impressions and images and the effect of these perceptions on their motivation in learning English. This qualitative study is based on the data about students' metaphors and the focus group interview to determine their effect on the students' motivation.…

  13. The impact of teachers' limited English proficiency on English ...

    African Journals Online (AJOL)

    A comparison of teacher and learner written errors was made. Based on the findings, a questionnaire was designed to determine the extent of the impact of teachers' limited English proficiency on learners' English proficiency. The findings of the questionnaire responses are presented. Recommendations are made on how ...

  14. Industrial Waste

    DEFF Research Database (Denmark)

    Christensen, Thomas Højlund

    2011-01-01

    of the industrial waste may in periods, depending on market opportunities and prices, be traded as secondary rawmaterials. Production-specificwaste from primary production, for example steel slag, is not included in the current presentation. In some countries industries must be approved or licensed and as part......Industrial waste is waste from industrial production and manufacturing. Industry covers many industrial sectors and within each sector large variations are found in terms of which raw materials are used, which production technology is used and which products are produced. Available data on unit...... generation rates and material composition as well as determining factors are discussed in this chapter. Characterizing industrial waste is faced with the problem that often only a part of the waste is handled in the municipal waste system, where information is easily accessible. In addition part...

  15. Researching awareness and attitudes : a study of world Englishes and English teachers in South Korea

    OpenAIRE

    Ahn, Hyejeong

    2017-01-01

    This study explores the awareness and attitudes of English teachers in South Korea (ETSK) toward eight selected varieties of English: American English (AmE), British English (BrE), Canadian English (CaE), Singaporean English (SiE), Indian English (InE), Chinese English (ChE), Japanese English (JaE) and Korean English (KoE). Data, consisting of 204 questionnaires and 63 interviews, is collected from both Korean and non-Korean English teachers, from two major regions, Busan Gyeongnam and Seoul ...

  16. 7 CFR 247.13 - Provisions for non-English or limited-English speakers.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 4 2010-01-01 2010-01-01 false Provisions for non-English or limited-English speakers... § 247.13 Provisions for non-English or limited-English speakers. (a) What must State and local agencies do to ensure that non-English or limited-English speaking persons are aware of their rights and...

  17. English RP: Ancient or Modern.

    Science.gov (United States)

    Gimson, Alfred C.

    1979-01-01

    Discusses changes in the pronunciation of colloquial Brltish English, reflecting changing social attitudes toward traditional Received Pronunciation. Finds that a study is needed to determine a new standard for the use of future foreign students of English. A pilot study is described. (IFS/WGA) i

  18. How is English "A" Pronounced?

    Science.gov (United States)

    Wakelin, Martyn F.

    1977-01-01

    Discusses, from both historical and sociolinguistic viewpoints, the changing of the phoneme /a/ in colloquial English. The rather "bright, moderately open" sound, once considered standard English, has been and is moving toward a more open and back articulation. (IFS/WGA)

  19. Electronic Learning of Business English

    OpenAIRE

    Milošević Danica

    2014-01-01

    This paper deals with one approach to organising electronic learning of a Business English language course. The paper will explain the basic structure of electronic learning, explore its principles and focus on the effects of this type of learning, trying to make English language teachers aware of the possibilities that this system has to offer to its users.

  20. Electronic Learning of Business English

    Directory of Open Access Journals (Sweden)

    Milošević Danica

    2014-03-01

    Full Text Available This paper deals with one approach to organising electronic learning of a Business English language course. The paper will explain the basic structure of electronic learning, explore its principles and focus on the effects of this type of learning, trying to make English language teachers aware of the possibilities that this system has to offer to its users.

  1. English Teaching at Lilydale High.

    Science.gov (United States)

    Mayer, Valerie; Matcott, Mark; Lyons, Janet; Flessa, Demi; Hayman, Anna; Hough, Peter

    2002-01-01

    Presents six narratives from teachers including: "VCE English at Lilydale High School" (Valerie Mayer); "Should 'I' Be Their Teacher" (Mark Matcott); "Teaching Poetry to Year 7 English Students" (Janet Lyons); "Creative Art Therapy and Mandalas" (Demi Flessa); "Would the 'Real' Teacher Please Stand…

  2. Cultural Identity in Korean English

    Science.gov (United States)

    Chang, Bok-Myung

    2010-01-01

    This study aims to investigate the cultural identity of Korean English and to make the intercultural communications among non-native speakers successful. The purposes of this study can be summarized as follows: 1) to recognize the concept of English as an International Language (EIL), 2) to emphasize cross-cultural understanding in the globalized…

  3. Instructional Materials Vocational Related English.

    Science.gov (United States)

    Oklahoma State Dept. of Vocational and Technical Education, Stillwater.

    This preliminary draft of instructional materials for an English curriculum offering vocational preparation focuses on grammar concepts, selected vocational English topics, and the use of resource materials. The unit plans contain general and specific behavioral objectives, student activities, and teaching procedures. Information sheets, student…

  4. ACCA College English Teaching Mode

    Science.gov (United States)

    Ding, Renlun

    2008-01-01

    This paper elucidates a new college English teaching mode--"ACCA" (Autonomous Cooperative Class-teaching All-round College English Teaching Mode). Integrated theories such as autonomous learning and cooperative learning into one teaching mode, "ACCA", which is being developed and advanced in practice as well, is the achievement…

  5. Japanese Attitudes toward English Accents.

    Science.gov (United States)

    Chiba, Reiko; And Others

    1995-01-01

    Examined the attitudes of 169 Japanese university students toward varieties of spoken English. Results found that the students with more instrumental motivation were more positive toward nonnative English accents than those with less instrumental motivation, and that the students' familiarity with accents had an influence on their acceptance of…

  6. What Matters in English Literature?

    Science.gov (United States)

    Parker, Fred

    2005-01-01

    The article talks about how--and whether--"English" can justify itself as an academic discipline, and about the pressures on it to do so. In the search for justification, is it the creative writer or the critic who provides the crucial element of value? Particular reference is made to the tradition of English at Cambridge, where the…

  7. Evaluating Workplace English Language Programs

    Science.gov (United States)

    Ekkens, Kristin; Winke, Paula

    2009-01-01

    Companies across the United States provide workplace English classes to non-native-English-speaking employees to increase productivity, retention, and on-the-job safety. Institutions that financially support the programs often require evidence of learning through standardized tests as a prerequisite for continued funding. However, the tests…

  8. Drug Facts

    Medline Plus

    Full Text Available ... some signs and symptoms of someone with a drug use problem? How Does Drug Use Become an Addiction? What Makes Someone More Likely ... So Hard to Quit Drugs? Effects of Drugs Drug Use and Other People Drug Use and Families Drug ...

  9. GLOBALIZATION, ANGLICISMS AND BUSINESS ENGLISH

    Directory of Open Access Journals (Sweden)

    Pop Anamaria-Mirabela

    2015-07-01

    Full Text Available For a long time, people have felt the need for a common language in order to communicate faster and better and English has become the global language, spreading across the world. Nowadays, more and more people learn and speak English for different reasons. The effect of it is that English started influencing the native languages of the speakers who use a great variety of words and expressions from English while speaking their respective languages. The aim of this paper is to analyze the influence of Anglicisms on the Romanian vocabulary, especially on the business vocabulary. Our paper focuses on English for Business and Economics, as we have been teaching business English to students from the Department of International Business for several years. The research undertaken in this paper is a theoretical research, concentrating on the controversies that surrounded this highly debated subject by the linguists: should Anglicisms be used in Romanian or not? In this regard, there are two sides: on one hand those who are rather supportive of the trend and those (and here we mention highly reputed Romanian linguists like George Pruteanu or Eugen Simion who were categorically against it. The paper provides the results of a survey conducted by “Special Eurobarometer 243” showing that English is the most widely spoken language in Europe with a score of 51%. The concept of “romgleza” tends to replace the Romanian language in large corporations and not only and this is a natural trend, considering the “invasion” of the English language. A conversation in “romgleza” combines Romanian and English elements, thus resulting a technical jargon, the English words being used especially in areas like IT, marketing, management. This is due to the fact that in these areas the daily exposure to English is higher because everything people in these fields do is connected to English. Romgleza appeared because in Romanian there are no words to express the

  10. Transformations in the English Classroom

    Directory of Open Access Journals (Sweden)

    Veronica L. Diptoadi

    2016-02-01

    Full Text Available In the past few years English has been taught at the elementary school level. However, many schools in Surabaya have introduced English in their curriculum at the pre-school level. In this paper the writer describes a Semi-International School in Surabaya as a model, because English is given since the play group level where students are about 2-3 years old. Thus, the focus of this paper is on be the reasons why English is taught at such an early age, constructivism as the theoretical base of the school curriculum, the English program based on topic-centered learning and activity-based approach and the facilities needed to support the whole teaching-learning process at the school

  11. Prepositions in MSA and English

    Directory of Open Access Journals (Sweden)

    Saad Nasser Aldwayan

    2013-01-01

    Full Text Available Spatial scenes are identical in the world languages. However, cultures may diverge in profiling spatial scenes (Levinson 2003. This paper selects for study the prepositions in and on in English and their Modern Standard Arabic (MSA counterparts fi and 3ala, arguing that MSA and English seem to diverge in the spatial configurations and meanings of these prepositions. The sub-schemas of CONTAINMENT (in-ness in MSA are found to partially overlap with those of English, with the other sub-schemas being taken care of by SUPPORT (on-ness and PUNCTUALITY (point-ness. Such differences classify MSA more as a CONTAINMENT-based language than English, which seems to prefer SUPPORT and PUNCTUALITY. However, English and MSA seem to converge in their metaphoric conceptualizations of states owing to conceptual embodiment (Lakoff 1987. The article discusses the implications of such findings for spatial cognition and cultural cognition and EFL/ESL writing and translating.

  12. Life after oral English certification

    DEFF Research Database (Denmark)

    Dimova, Slobodanka

    2017-01-01

    Internationalization of higher education has resulted in rapid developments of English-medium instruction (EMI) courses in non-Anglophone countries in Europe and Asia. Due to the growing concerns about lecturers' ability to teach in English, several European universities have implemented policies...... for internal assessment of lecturers' English proficiency to ensure the quality of teaching in EMI programs. However, research on the measured construct and the reliability and the validity of these assessments remains scarce. Based on interviews with tested university lecturers and formative feedback analysis......, this study discusses the consequences resulting from score and feedback interpretations and uses as part of the validation process of TOEPAS (Test of Oral English Proficiency for Academic Staff), which is a performance-based test used for oral English certification of lecturers at the University...

  13. Nordic Journal of English Studies

    DEFF Research Database (Denmark)

    2008-01-01

    In difficult economic times, the place of education in the economy comes to the forefront with questions about how effective our programs are in preparing students to become contributing members of the workforce and society. As the discipline of English studies sits at the cross-roads of humanities...... and education for a global society, it has traditionally enjoyed high enrollments and unquestioned value. However, two trends are affecting the position of English studies in the academy: 1) the emergence of communication studies as a discipline and 2) the movement towards education in English as a global...... language across many disciplines in Scandinavia. Because of these movements, the place and purpose for English studies is being called into question. In addition, the ability of an English studies degree in preparing students for the global workforce is also being examined. To address these emergent trends...

  14. Teaching the Dutch how to pronounce English

    NARCIS (Netherlands)

    Hermans, Frans; Sloep, Peter

    2018-01-01

    The Dutch overestimate their English speaking skills. Their pronunciation is not always convincing, and certain pronunciation mistakes are easily recognised as being typical for Dutch speakers of English. Although intelligibility cannot exist without adequate pronunciation, teaching English

  15. Teaching the Dutch how to pronounce English

    NARCIS (Netherlands)

    Frans Hermans; Peter Sloep

    2015-01-01

    The Dutch overestimate their English speaking skills. Their pronunciation is not always convincing and certain pronunciation mistakes are easily recognised as being typical for Dutch speakers of English. Although intelligibility cannot exist without adequate pronunciation, teaching English

  16. Language "Skills" and the Neoliberal English Education Industry

    Science.gov (United States)

    Shin, Hyunjung

    2016-01-01

    Neoliberal transformation of self, learning, and teaching constructs individuals as bundles of skills (or human capital) and subordinates learning to skill production characterized by an ethic of entrepreneurial self-management [Urciuoli, Bonnie. 2010. "Neoliberal Education: Preparing the Student for the New Workplace." In…

  17. More Danish, More English

    DEFF Research Database (Denmark)

    Chopin, Kimberly Renée

    Universities in Denmark are becoming increasingly internationalized, and areincreasingly using English as a language of research, teaching, and administration. At the same time, the Danish language is seen by some as being under threat, and Danish public discourse has focused on what role.......This study investigated the decision making process over time in order to reveal how such language policies would be received in one affected department. Interviews with department teaching staff were carried out both before and after the implementation of the decisions, along with interviews of department...... and faculty level leadership, classroom observations and analysis of written documents. Data was organized using the model provided by Innovation Theory (Henrichsen, 1989), and interpreted using the discursive framework of Nexus Analysis (Scollon & Scollon, 2004).Analysis showed how case department teaching...

  18. Drug allergies

    Science.gov (United States)

    Allergic reaction - drug (medication); Drug hypersensitivity; Medication hypersensitivity ... A drug allergy involves an immune response in the body that produces an allergic reaction to a medicine. The ...

  19. The use of simplified English language for writing technical documentation: The proposal for a research project

    Directory of Open Access Journals (Sweden)

    Pendić Zoran R.

    2016-01-01

    Full Text Available Natural language permits an enormous amount of expressive variation. Writers, especially technical writers, tend to develop special vocabularies (jargons, styles, and grammatical constructions. Technical language becomes opaque not just to ordinary readers, but to experts as well. The problem becomes particularly acute when such text is translated into another language, since the translator may not even be an expert in the technical domain. Controlled Languages (CL have been developed to counter the tendency of writers to use unusual or overly-specialized, inconsistent language [1, Section 7.6]. Engineering professionals know that making text understandable is very challenging in domestic environment (Serbian language, and especially in an international environment (mostly English language. Simplified Serbian language could help in domestic environment. Simplified English language already helps in international environment. Simplified English is sometimes used as a generic term for a controlled language. Simplified English is the original name of a controlled language originally developed for aerospace industry to facilitate the use of maintenance manuals by engineers for whom English is not the native language. It is now officially known under its trademarked name as Simplified Technical English (STE. Although STE is developed for use in the aerospace and defense industries, other industries have used it as a basis for developing their own controlled English standards, which are mostly used for making appropriate technical documentation.

  20. English Teachers, Angels & Poverty: Writing on English Curriculum and Pedagogy (Reflections on Editing "English in Australia").

    Science.gov (United States)

    Doecke, Brenton

    2002-01-01

    Explores the cultural politics of writing about English curriculum and pedagogy, focusing on the author's role as the editor of this journal. Describes his role as editor as one of providing a discursive space in which English teachers and literacy educators can begin to write about their work. (SG)

  1. Effective instruction for English learners.

    Science.gov (United States)

    Calderón, Margarita; Slavin, Robert; Sánchez, Marta

    2011-01-01

    The fastest-growing student population in U.S. schools today is children of immigrants, half of whom do not speak English fluently and are thus labeled English learners. Although the federal government requires school districts to provide services to English learners, it offers states no policies to follow in identifying, assessing, placing, or instructing them. Margarita Calderón, Robert Slavin, and Marta Sánchez identify the elements of effective instruction and review a variety of successful program models. During 2007-08, more than 5.3 million English learners made up 10.6 percent of the nation's K-12 public school enrollment. Wide and persistent achievement disparities between these English learners and English-proficient students show clearly, say the authors, that schools must address the language, literacy, and academic needs of English learners more effectively. Researchers have fiercely debated the merits of bilingual and English-only reading instruction. In elementary schools, English learners commonly receive thirty minutes of English as a Second Language (ESL) instruction but attend general education classes for the rest of the day, usually with teachers who are unprepared to teach them. Though English learners have strikingly diverse levels of skills, in high school they are typically lumped together, with one teacher to address their widely varying needs. These in-school factors contribute to the achievement disparities. Based on the studies presented here, Calderón, Slavin, and Sánchez assert that the quality of instruction is what matters most in educating English learners. They highlight comprehensive reform models, as well as individual components of these models: school structures and leadership; language and literacy instruction; integration of language, literacy, and content instruction in secondary schools; cooperative learning; professional development; parent and family support teams; tutoring; and monitoring implementation and outcomes

  2. Drug Facts

    Medline Plus

    Full Text Available ... Drug Use and Kids Drug Use and Unborn Children Drug Use and Your Health Other Effects on ... Someone Find Treatment and Recovery Resources? Prevention Help Children and Teens Stay Drug-Free Talking to Kids ...

  3. Drug Facts

    Medline Plus

    Full Text Available ... Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug Use and HIV/AIDS Treatment & ...

  4. Drug Facts

    Medline Plus

    Full Text Available ... Use and Unborn Children Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug ...

  5. Drug Safety

    Science.gov (United States)

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  6. Drug Facts

    Medline Plus

    Full Text Available ... and symptoms of someone with a drug use problem? How Does Drug Use Become an Addiction? What ... Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug Use ...

  7. Eco-efficiency in industrial production

    NARCIS (Netherlands)

    von Raesfeld Meijer, Ariane M.; de Bakker, F.G.A.; Groen, Arend J.

    2001-01-01

    English AbstractThis report of the MATRIC project investigated 'Eco-efficiency in industrial production'. After a general introduction into the domain of eco-efficiency, the first part of this report further focusses on the organisation of Product-Oriented Environmental Management (POEM), which is

  8. Communication Skills for the Cosmetology Industry.

    Science.gov (United States)

    Rader, Wendy

    This teaching guide contains materials for 24 2-hour lessons for people with limited English proficiency who are seeking a job in the cosmetology industry or seeking enrollment in cosmetology courses. The course is intended to improve students' abilities to communicate orally with customers in a cosmetology setting and to improve job seeking and…

  9. Industrial Robots.

    Science.gov (United States)

    Reed, Dean; Harden, Thomas K.

    Robots are mechanical devices that can be programmed to perform some task of manipulation or locomotion under automatic control. This paper discusses: (1) early developments of the robotics industry in the United States; (2) the present structure of the industry; (3) noneconomic factors related to the use of robots; (4) labor considerations…

  10. Students’ Motivation in Speaking English

    Directory of Open Access Journals (Sweden)

    Mas Darul Ihsan

    2016-05-01

    Full Text Available As the English teacher in the classroom, there will be some problems or conditions need to be accomplished. Teacher will see some of the students are very motivated, motivated or even feeling ignored in studying English. The learners who have contacted with English will find that some features are quite easy and extremely difficult. One of the more complicated problems of second or foreign languages learning and  teaching has been to define and apply the construct of motivation in the classroom. Motivation is a concept without physical reality, we cannot see motivation; we see effort, interest, attitude and desire. For speaking, it is important first to give competence and then performance. Competence is more likely to the extent a communicator is motivated to be so. Motivation is the extent to which a communicator is drawn towards or pushed away from communicating competently in a given context then performed. This is a descriptive  quantitative research. The data obtained from the questionnaire distributed and analyzed to get the result.  The date taken from the students of Muhammadiyah 1 Senior High School Gresik in Easy-Speaking course. The researcher wanted to know the students’ motivation in practicing speaking English in Easy-Speaking course. The results show that 1 the learners effort in practicing speaking English is 56.1 %. 2 The learners’ interest in practicing speaking English is 49.7 %. 3 The learners’ attitude towards practicing speaking English is 59.9 %. 4 The learners’ desire in practicing speaking English is 71.43 %. Then, some suggestions are made: 1 Using media is very important both to increase the learners’ motivation and to give a big opportunity to learners to explore their idea. 2 Giving more variations techniques in teaching and learning process in order do not monotonous. 3 Giving prizes, encouraging and giving extra points for learners who can express their idea by speaking English well. 4 Creating

  11. Is English a dyslexic language?

    Science.gov (United States)

    Spencer, K

    2000-01-01

    McGuinness has suggested that there 'is no diagnosis and no evidence for any special type of reading disorder like dyslexia', and that poor teaching accounts for low levels of English literacy performance, rather than inherent personal deficits. Implicit in this is the assumption that some languages have simple grapheme-phoneme codes in which there is a one-to-one mapping, making them easy to teach and learn, while others have more complicated structures and are more difficult for teachers and students. There is now an increasing number of studies which demonstrate that readers in more transparent orthographies such as Italian, Spanish, Turkish, Greek and German have little difficulty in decoding written words, while English children have many more problems. Increasingly, lack of orthographic transparency in English is seen as having a powerful negative effect on the development of reading skills in English-speaking children. There is evidence that English-speaking children who fail to acquire reading skills may fall into two distinct categories: those who would succeed in languages, other than English, that have greater orthographic consistency; and those who would still have problems even with perfect orthographic transparency. The first, larger, group is let down by the interaction of poor teaching methods and an incomprehensible system of orthography. The present study examines word factors associated with poor spelling and reading that have been identified. Three factors account for the relative ease with which pupils can spell words: frequency of the word in the English language; length of the word; and the presence of 'tricky' letters or letter combinations. Data are presented illustrating the predictive model of spelling and reading which enables word difficulty to be calculated from the characteristics of English words. The implications the model has for teaching and learning English are elaborated, with reference to the possible benefits to be derived

  12. 2001 Industry Studies: Services Industry

    National Research Council Canada - National Science Library

    Cervone, Michael

    2001-01-01

    .... has maintained its economic strength in traditional services industries such as transportation, tourism, public utilities, finance and insurance, accounting, engineering, architecture, medical, legal...

  13. Industry honoured

    CERN Multimedia

    2008-01-01

    CERN has organised a day to thank industry for its exceptional contributions to the LHC project. Lucio Rossi addresses CERN’s industrial partners in the Main Auditorium.The LHC inauguration provided an opportunity for CERN to thank all those who have contributed to transforming this technological dream into reality. Industry has been a major player in this adventure. Over the last decade it has lent its support to CERN’s teams and participating institutes in developing, building and assembling the machine, its experiments and the computing infrastructure. CERN involved its industrial partners in the LHC inauguration by organising a special industry prize-giving day on 20 October. Over 70 firms accepted the invitation. The firms not only made fundamental contributions to the project, but some have also supported LHC events in 2008 and the inauguration ceremony through generous donations, which have been coordinated by Carmen Dell’Erba, who is responsible for secu...

  14. Non-Native & Native English Teachers

    Directory of Open Access Journals (Sweden)

    İrfan Tosuncuoglu

    2017-12-01

    Full Text Available In many countries the primary (mother tongue language is not English but there is a great demand for English language teachers all over the world. The demand in this field is try to be filled largely by non-native English speaking teachers who have learned English in the country or abroad, or from another non native English peaking teachers. In some countries, particularly those where English speaking is a a sign of status, the students prefer to learn English from a native English speaker. The perception is that a non-native English speaking teacher is a less authentic teacher than a native English speaker and their instruction is not satifactory in some ways. This paper will try to examine the literature to explore whether there is a difference in instructional effectiveness between NNESTs and native English teachers.

  15. 21 CFR 207.40 - Establishment registration and drug listing requirements for foreign establishments.

    Science.gov (United States)

    2010-04-01

    ... in the English language. (c) Each foreign drug establishment required to register under paragraph (a... requirements for foreign establishments. 207.40 Section 207.40 Food and Drugs FOOD AND DRUG ADMINISTRATION... LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION Procedure for Foreign Drug Establishments § 207.40...

  16. English Grammar Workbook For Dummies

    CERN Document Server

    O'Sullivan, Nuala

    2010-01-01

    English Grammar Workbook For Dummies, UK Edition is grammar First Aid for anyone wanting to perfect their English and develop the practical skills needed to write and speak correctly. Each chapter focuses on key grammatical principles, with easy-to-follow theory and examples as well as practice questions and explanations. From verbs, prepositions and tenses, to style, expressions and tricky word traps, this hands-on workbook is essential for both beginners looking to learn and practise the basics of English grammar, and those who want to brush up skills they already have - quickly, easily, and

  17. Life after oral English certification

    DEFF Research Database (Denmark)

    Dimova, Slobodanka

    2017-01-01

    Internationalization of higher education has resulted in rapid developments of English-medium instruction (EMI) courses in non-Anglophone countries in Europe and Asia. Due to the growing concerns about lecturers' ability to teach in English, several European universities have implemented policies...... for internal assessment of lecturers' English proficiency to ensure the quality of teaching in EMI programs. However, research on the measured construct and the reliability and the validity of these assessments remains scarce. Based on interviews with tested university lecturers and formative feedback analysis...

  18. Summer Oral Expression English course

    CERN Multimedia

    2012-01-01

    An English Oral Expression course will take place this summer from 20 August to 29 September.   Schedule: to be determined (2 sessions of 2 hours per week). Please note that this course is for learners who have a good knowledge of English (CERN level 7 upwards). If you are interested in following this course, please enroll through this link. Please be sure to indicate your planned absences in the comments field so we can schedule the course. If you need more information please send a message to English.training@cern.ch

  19. Summer Oral Expression English course

    CERN Multimedia

    2012-01-01

    An English Oral Expression course will take place this summer at some time between 25 June and 28 September. The exact dates will be decided according to the preferences of the students.   Schedule: to be determined (2 sessions of 2 hours per week). Please note that this course is for learners who have a good knowledge of English (CERN level 7 upwards). If you are interested in following this course, please enroll through this link. Please be sure to indicate your planned absences in the comments field so we can schedule the course. If you need more information please send a message to English.training@cern.ch

  20. Summer Oral Expression English course

    CERN Multimedia

    2013-01-01

    An English Oral Expression course will take place this summer at some time between August 19 and October 4.   Schedule: to be determined (2 sessions of 2 hours per week). Please note that this course is for learners who have a good knowledge of English (CERN level 7 upwards). If you are interested in following this course, please enroll through this link. Please be sure to indicate your planned absences in the comments field so we can schedule the course. If you need more information please send a message to English.training@cern.ch.

  1. Working in English student's book

    CERN Document Server

    Jones, Leo

    2001-01-01

    Working In English is a comprehensive course for Business English learners from Leo Jones, co-author of the successful New International Business English course. The core course comprises 40 one-hour units, focusing on thye practical day-to-day activities that all business people are involved in, and organised into seven modules. It is supplemented by extra activities from the Teacher's Book to offer maximum flexibility. The accompanying Video contains specially filmed documentary sequences, made in Europe and the USA, that relate to the themes of the modules and provide authentic input to the course.

  2. Industrial guide to chemical and drug safety

    National Research Council Canada - National Science Library

    Diwan, Prakash V; Dikshith, T. S. S

    2003-01-01

    ... References 51 Chapter 3 Heavy Metals 59 Introduction 59 Metals and Toxicity Aluminum Arsenic Barium Beryllium Cadmium Chromium Cobalt Lead Manganese Mercury and Methyl Mercury Nickel Zinc 61 62 63 65...

  3. DRUG COSTS UPDATE ON THE PHARMACEUTICAL INDUSTRY

    African Journals Online (AJOL)

    Enrique

    The initiative involves a venture with two Indian pharmaceutical companies and a South African generic medicine manufacturer (Aspen Pharmacare). These companies will be manufacturing generic antiretroviral medication — funding from the Foundation will allow a further reduction in price. A target annual cost quoted is.

  4. International English teachers' perceptions of English as an international language

    OpenAIRE

    Altun-Evci, Hatice

    2010-01-01

    Ankara : The Department of Teaching English as a Foreign Language, Bilkent University, 2010. Thesis (Master's) -- Bilkent University, 2010. Includes bibliographical references leaves 117-126. English as an International Language (EIL) and its implications for ELT have been keenly debated throughout the last two decades. Many researchers have in some depth elaborated on the issues of identity and voice, linguistic imperialism, and the importance of non-native speakers and the...

  5. NEEDS ANALYSIS OF ENGLISH LITERATURE STUDENTS IN ENGLISH ORAL COMMUNICATION

    Directory of Open Access Journals (Sweden)

    Angga Maulana

    2017-12-01

    Full Text Available The purpose of this study is to identify factual information about the needs of students of English Literature in the activities and supporting factors of oral communication by using English, whether linguistic and non-linguistic, and analyzing the difficulties of the situation of oral communication of English Literature students using English. This research uses descriptive method. Data collection is done through two stages: the questionnaire and the interview, followed by the review of someliteratures. The results of this study indicate that in general the students of English Literature feel that participating in a formal discussion is more important than the informal. While in terms of ability in the oral communication activity, generally students mastered informal communication activities. In terms of linguistic factors, the choice of vocabularies, and good and correct sentences are considered very important, although they only feel quite capable in it. It is also found that talking with self-confidence, having proper English pronunciation and mastering the topic of conversation become the important non-linguistic factors. The same thing does not happen on loudness and facial mimic. In general, students feel it is not important enough to master. Regarding situations that facilitate students in oral communication in English, they generally feel that well preparation, self-confidence, and mastery over vocabulary and what is being discussed becomes an easier factor. Different things revealed by most students about the difficult vocabulary and the lack of preparation in oral communication. It is difficult. As for things that require improvement, students generally feel that the confidence and the amount of vocabulary that is mastered should be improved in order to improve the quality of oral communication in English.

  6. English-language learners’ problem solving in Spanish versus English

    OpenAIRE

    Ambrose, Rebecca; Molina, Marta

    2010-01-01

    To explore the role of language in English Language Learners (ELLs)´ problem solving, we compare the performance of a group of Latino first graders when working in Spanish and in English on two equivalent sets of story problems. We contrast our results with others from previous studies with bilingual and monolinguals children by focusing on students´ performance in problems with the same semantic structure. This comparison leads us to discuss some factors influencing students´ problem solving...

  7. Learning Strategies in Alleviating English Writing Anxiety for English Language Learners (ELLs) with Limited English Proficiency (LEP)

    Science.gov (United States)

    Wu, Chia-Pei; Lin, Huey-Ju

    2016-01-01

    This study utilized the Oxford Strategy Inventory for Language Learning (SILL) and an English writing anxiety scale to examine the relationship between learning strategies and English writing anxiety in 102 university-level English language learners (ELLs) with Limited English Proficiency (LEP) in a university in Taiwan. Kruskal Wallis Test…

  8. English romantic verse drama

    Directory of Open Access Journals (Sweden)

    Andrejević Ana

    2007-01-01

    Full Text Available The changes in the nature of drama and particularly the historical decline of drama as a literary form, in the eighteenth and early nineteenth centuries correspond directly to the crisis of social class, which involved the transition - in England - from an aristocratic to a middle - class social order. In the framework of those social and also historical changes in Europe, English romantic verse drama gives the answer to the social reality through the vision of free and individualized characters. The pain, intensive sensitivity of the romantics, irrationality of the sublime ideas and the poetic style of the blank verse are the main characteristics of these dramas which diachronically influenced this genre in Victorian and modern era. Wordsworth, Coleridge, Shelley, Byron and others put the passionate individualist with his ideas of freedom and love in the center of dramatic action. Byron's dramas stand as the greatest and most articulate voice of Romantic drama. Whatever its aesthetic merits or shortcomings, and however traditional scholars may situate it within the frames of literary history Romantic drama occupies a critically important position in the social history of Romanticism but it also represents an important link in the development of verse drama from the Shakespeare to the modern age.

  9. Teaching English Through Literature

    Directory of Open Access Journals (Sweden)

    Murat Hişmanoğlu

    2005-04-01

    Full Text Available This paper aims at emphasizing the use of literature as a popular technique for teaching both basiclanguage skills (i.e. reading, writing, listening and speaking and language areas (i.e. vocabulary,grammar and pronunciation in our times. Reasons for using literary texts in foreign language classroomand main criteria for selecting suitable literary texts in foreign language classes are stressed so as tomake the reader familiar with the underlying reasons and criteria for language teachers’ using andselecting literary texts. Moreover, literature and the teaching of language skills, benefits of differentgenres of literature (i.e. poetry, short fiction, drama and novel to language teaching and some problemsencountered by language teachers within the area of teaching English through literature (i.e. lack ofpreparation in the area of literature teaching in TESL / TEFL programs, absence of clear-cut objectivesdefining the role of literature in ESL / EFL, language teachers’ not having the background and trainingin literature, lack of pedagogically-designed appropriate materials that can be used by language teachersin a classroom context are taken into account.

  10. English and French courses

    CERN Document Server

    2014-01-01

    If one of your New Year’s resolutions is to learn a language, there is no excuse anymore!   You can attend one of our English or French courses and you can practise the language with a tandem partner! General and Professional French Courses The next session will take place from 27 January to 4 April 2014. These courses are open to all persons working on the CERN site, and to their spouses. Oral Expression This course is aimed at students with a good knowledge of French who want to enhance their speaking skills. Speaking activities will include discussions, meeting simulations, role-plays etc. The next session will take place from 27 January to 4 April 2014. Writing professional documents in French These courses are designed for non-French speakers with a very good standard of spoken French. The next session will take place from 27 January to 4 April 2014. Cours d’anglais général et professionnel La prochaine session se déroulera du 3 mars a...

  11. Business Writing in Freshman English.

    Science.gov (United States)

    Larmouth, Donald W.

    1980-01-01

    Suggests incorporating business writing into a freshman English course. Outlines three writing and research assignments: a financial status memorandum, a management analysis report, and an evaluation of applicants for a position at a university. (TJ)

  12. Industrious Landscaping

    DEFF Research Database (Denmark)

    Brichet, Nathalia Sofie; Hastrup, Frida

    2018-01-01

    This article offers a history of landscaping at Søby brown coal beds – a former mining site in western Denmark. Exploring this industrial landscape through a series of projects that have made different natural resources appear, we argue that what is even recognized as resources shifts over time...... has been seen interchangeably to rest with brown coal business, inexpensive estates for do-it-yourself people, pasture for grazing, and recreational forest, among other things. We discuss these rifts in landscaping, motivated by what we refer to as industriousness, to show that in an industrial site...

  13. Industrial ecology.

    Science.gov (United States)

    Patel, C K

    1992-01-01

    Industrial ecology addresses issues that will impact future production, use, and disposal technologies; proper use of the concept should reduce significantly the resources devoted to potential remediation in the future. This cradle-to-reincarnation production philosophy includes industrial processes that are environmentally sound and products that are environmentally safe during use and economically recyclable after use without adverse impact on the environment or on the net cost to society. This will require an industry-university-government round table to set the strategy and agenda for progress. PMID:11607254

  14. Chemistry in the Pharmaceutical Industry

    Science.gov (United States)

    Poindexter, Graham S.; Pendri, Yadagiri; Snyder, Lawrence B.; Yevich, Joseph P.; Deshpande, Milind

    This chapter will discuss the role of chemistry within the pharmaceutical industry. Although the focus will be upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first world nations such as Japan and those in Europe. The major objective of the pharmaceutical industry is the discovery, development, and marketing of efficacious and safe drugs for the treatment of human disease. Of course drug companies do not exist as altruistic, charitable organizations but like other share-holder owned corporations within our capitalistic society must achieve profits in order to remain viable and competitive. Thus, there exists a conundrum between the dual goals of enhancing the quality and duration of human life and that of increasing stock-holder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships this places upon the elderly and others of limited income.

  15. Summer Oral Expression English Course

    CERN Multimedia

    HR Department

    2011-01-01

    An English Oral Expression course will take place between 15 August and 30 September 2011. Schedule: to be determined (2 sessions of 2 hours per week). Please note that this course is for learners who have a good knowledge of English (CERN level 7 upwards). If you are interested in following this course, please enrol here. Or contact: Kerstin FUHRMEISTER (70896) Tessa OSBORNE (72957)  

  16. Humor and Satire in the English Classroom.

    Science.gov (United States)

    Donelson, Kenneth, Ed.

    1973-01-01

    According to the "Arizona English Bulletin" (AEB), not enough attention is given to humor or satire in high school English classes. AEB suggests that if the English class is a place for bringing reality into the curriculum, humor must become a part of the total English program. Featured in this issue are 25 essays on various aspects of…

  17. Teaching English as an International Language

    Science.gov (United States)

    Selvi, A. F.; Yazan, B.

    2013-01-01

    English has unquestionably become a global phenomenon, generating a fundamental discussion of EIL pedagogy for English language teaching practitioners around the world. Teaching English as an International Language captures this important moment in the history of English language teaching. Readers will find an accessible introduction to the past,…

  18. English Teaching Profile: Yemen Arab Republic.

    Science.gov (United States)

    British Council, London (England). English Language and Literature Div.

    A description of the role and status of the English language in the Yemen Arab Republic begins with a general statement concerning the distribution of English speakers and the use of English language materials. Subsequent sections outline: (1) the use and status of English within the educational system at all levels, including teacher education;…

  19. Globalization and English in Chinese Higher Education

    Science.gov (United States)

    Chang, Junyue

    2006-01-01

    This paper sets China's education of English majors within the changing global and national context. It examines the impact of accelerating globalisation and the rise of global English, the adjustment of China's English language policy, the growth of the education of English majors and the challenges faced by this sector of education. To adapt to…

  20. Future English Teachers' Attitudes towards EIL Pronunciation

    Science.gov (United States)

    Coskun, Abdullah

    2011-01-01

    English has become the world's international language, used for international communication mostly among non-native speakers of other languages and 80 percent of all the English teachers around the world are nonnative English-speaking (NNES) teachers (Canagarajah, 1999). Therefore, there is a growing need to investigate the EIL (English as an…

  1. English Teaching Profile: Sabah--Malaysia.

    Science.gov (United States)

    British Council, London (England). English Language and Literature Div.

    This review of the status of English language instruction in Sabah, Malaysia, provides an overview of the role of English in the society in general and outlines the status of English use and instruction in both the Chinese and government educational systems at all levels. Topics covered are: the characteristics and training of English language…

  2. English Activation through Art: Tensions and Rewards

    Science.gov (United States)

    Choi, Tat Heung

    2017-01-01

    This article describes a unit of work framed by a rationale for activating English language learning through arts-based practices that are suitable for preservice teachers who are nonnative speakers of English (seeking certification for teaching English as a second language). Because teachers of English are expected to use language arts to promote…

  3. English Around the World, Number 6.

    Science.gov (United States)

    McCulloch, John I. B., Ed.

    This newsletter discusses the teaching and role of English around the world. Articles also cover English-language media in a given country, and the opportunity and need for understanding and speaking English in that country. This particular issue contains items on English-language education and use in Belgium, Poland, Afghanistan, Hungary,…

  4. On the Practice Teaching of English Reading

    Science.gov (United States)

    Gao, Yonghong

    2009-01-01

    The main task of practice teaching of English Reading is to train students' independent reading ability and good reading habits. Extra-curricular reading of English literature and English newspapers and magazines plays an active role in improving English reading ability. The principle of selecting reading materials, the scope of selection and the…

  5. Hindsight of an English Language Learner.

    Science.gov (United States)

    Dam, Phap

    This keynote address by a native Vietnamese speaker who did not learn English until he was college-age, through the now obsolete "grammar-translation" method, recounts his difficulties in learning to converse orally in English. He stresses the need to teach conversational English to English Language Learners (ELLs) in addition to…

  6. The Mental Lexicon and English Vocabulary Teaching

    Science.gov (United States)

    He, Huaqing; Deng, Yunfei

    2015-01-01

    In China, English as a foreign language (EFL) learning mainly occurs in the classroom, and the resultant lack of practice using English in authentic settings makes it quite difficult for many Chinese learners to learn English words. They may often feel that English words are "difficult to learn and easy to forget." As such, how to…

  7. English Around the World, Number 2.

    Science.gov (United States)

    McCulloch, John I. B., Ed.

    This newsletter discusses the teaching and role of English around the world. Articles also cover English-language media in a given country, and the opportunity and need for understanding and speaking English in that country. This particular issue contains items on English-language education and use in Malaysia, Singapore, Israel, Jordan, Tunisia,…

  8. Negotiated Syllabus in EAP Business English Courses.

    Science.gov (United States)

    Boyle, Erlinda R.

    Negotiation of syllabus design and content in college-level business English is discussed, looking at three types: negotiation between teachers of business English, between teachers and students of business English, and between business English and content-area business teachers. Examples of practice from the Chinese University of Hong Kong are…

  9. English Around the World, Number 3.

    Science.gov (United States)

    McCulloch, John I. B., Ed.

    This newsletter discusses the teaching and role of English around the world. Articles also cover English-language media in a given country, and the opportunity and need for understanding and speaking English in that country. This particular issue contains items on English education and use in Yugoslavia, Norway, Iceland, Finland, Kenya, Pakistan,…

  10. English Textbooks in Japan and Korea

    Science.gov (United States)

    Yuasa, Katsura

    2010-01-01

    English education in Japan and Korea are similar in some respects. Although both countries are not completely but mostly monolingual societies, where citizens do not need English in their daily life, they have begun to realize the importance of English as a tool for international communication, and as a result their English education is becoming…

  11. English Language Teaching Profile: Central African Republic.

    Science.gov (United States)

    British Council, London (England). English-Teaching Information Centre.

    This profile in outline form of the English language teaching situation in the Central African Republic discusses the role of English and English within the educational system. While French is the official language and Sango is the national language, English is taught in all secondary schools, is used as the medium of instruction in the University…

  12. English Language Teaching Profile: Hong Kong.

    Science.gov (United States)

    British Council, London (England). English-Teaching Information Centre.

    This profile in outline form of the English language teaching situation in Hong Kong provides a brief background of the social, economic, and linguistic situation, and covers the following topics: the role of English, English within the educational system, the teaching cadre, teaching materials, English outside the educational system, and British…

  13. Black Teachers of English in South Korea

    Science.gov (United States)

    Charles, Quanisha D.

    2017-01-01

    This study used narrative inquiry as a methodological tool and Critical Race Theory (CRT) as a lens to examine how the term native English speaker (NES) is socially constructed when subscribed by Black teachers of English (BTE) in South Korea. In addition to examining how Black teachers of English interpret the term native English speaker, this…

  14. Collocations in Marine Engineering English

    Directory of Open Access Journals (Sweden)

    Mirjana Borucinsky

    2016-05-01

    Full Text Available Collocations are very frequent in the English language (Hill, 2000, and they are probably the most common and most representative of English multi-word expressions (Lewis, 2000. Furthermore, as a subset of formulaic sequences, collocations are considered to be a central aspect of communicative competence (Nation, 2001. Hence, the importance of teaching collocations in General English (GE as well as in English for Specific Purposes (ESP is undeniable. Understanding and determining the relevant collocations and their mastery are of “utmost importance to a ME instructor” (Cole et al., 2007, p. 137, and collocations are one of the most productive ways of enriching vocabulary and terminology in modern ME. Vişan & Georgescu (2011 have undertaken a relevant study on  collocations and “collocational competence” on board ships, including mostly nautical terminology. However, no substantial work on collocations in Marine Engineering English as a sub-register of ME has been carried out. Hence, this paper tries to determine the most important collocations in Marine Engineering English, based on a small corpus of collected e-mails. After determining the most relevant collocations, we suggest how to implement these in the language classroom and how to improve the collocational competence of marine engineering students.

  15. Chinese English Learners' Strategic Competence.

    Science.gov (United States)

    Wang, Dianjian; Lai, Hongling; Leslie, Michael

    2015-12-01

    The present study aims to investigate Chinese English learners' ability to use communication strategies (CSs). The subjects are put in a relatively real English referential communication setting and the analyses of the research data show that Chinese English learners, when encountering problems in foreign language (FL) communication, are characterized by the frequent use of substitution, approximation, circumlocution, literal translation, exemplification, word-coinage, repetition, and the infrequent use of cultural-knowledge and paralinguistic CSs. The rare use of paralinguistic strategies is found to be typical of Chinese English learners. The high frequency of literal translation, one first language (L1)-based strategy in our study sample, suggests that FL learners' use of L1-based CSs may depend more upon the developmental stage of their target language than the typology distance between L1 and the target language. The frequency of repetition reveals one fact that the Chinese English learners lack variety and flexibility in their use of CSs. Based on these findings, it was indicated that learners' use of CSs is influenced by a variety of factors, among which the development stage of their interlanguage and their cultural background are identified as two important factors. Some implications are finally suggested for the English foreign language teaching practice in China.

  16. The School of Business English

    Directory of Open Access Journals (Sweden)

    Lyudmila S. Pichkova

    2014-01-01

    Full Text Available School of Business English prepare students for translation and abstracting economic texts, business correspondence and business communication originated in the late 1950s. Department of English Language № 2 pioneered the creation of the school of business English at MGIMO and made the largest contribution to its development. Developing and using the latest educational technology, actively participating in many innovative projects, responsive to changes in the economic and socio-political sphere and carefully studying the international experience, the Department has become the undisputed leader in language teaching profession. The emphasis is on the use of the advantages of a new method of object-language integrated learning, in which the program of teaching business English are built in close coordination with training programs on special subjects, and sometimes supplement them. Business games, round tables, student conferences in English have become long-term practice of the English Language № 2. Specialty permeates all stages and aspects of learning, including the common language practice.

  17. Industrial pioneers

    NARCIS (Netherlands)

    Wassink, J.

    2014-01-01

    With their knowledge of metallurgy, mechanics and thermodynamics, mechanical engineers had to give shape to the industrial revolution in the Netherlands 150 years ago. This revolution only slowly gathered momentum, however, especially in comparison with England.

  18. Electronics Industry

    National Research Council Canada - National Science Library

    Ginter, Michael J; Andersen, James L; Becker, John A; Belliveau, Gerald E; Eppich, Frank J; Awai, Herman T; Hanko, David J; Hughes, Bob; Jones, Douglas; Larson, Kelly J

    2007-01-01

    .... The report is the culmination of a focused series of classroom seminar sessions and meetings with industry, government, and academic leaders through field studies in the metropolitan Washington, D.C...

  19. Industrial practices

    International Nuclear Information System (INIS)

    Velasquez Torrez, Patricia Irma

    1999-01-01

    This document reports the industrial practices carried out by the author viewing the requirements fulfilled for obtention the academic degree in chemical engineering of the San Andres University - Bolivia

  20. Industry consolidation

    OpenAIRE

    Coimbra, Diogo

    2017-01-01

    The following case study is intended to describe the evolution of the American cable industry and the corporate actions pursued by its operators and sponsors since 1990’s. Charter Communications and Time Warner Cable, respectively the fourth- and second-largest cable operators, have been chosen to represent the industry trend of horizontal consolidation. On May 23, 2015, both firms agreed to merge forming New Charter, along with parallel Charter’s acquisition of Bright House Networks. Even th...