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Sample records for english drugs industry

  1. New Zealand's drug development industry.

    PubMed

    Lockhart, Michelle Marie; Babar, Zaheer-Ud-Din; Carswell, Christopher; Garg, Sanjay

    2013-09-13

    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.

  2. Drug use in English professional football

    PubMed Central

    Waddington, I; Malcolm, D; Roderick, M; Naik, R; Spitzer, G

    2005-01-01

    Objectives: To examine several issues related to drug use in English professional football. More particularly the project sought to gather data on: players' use of permitted supplements (mineral and vitamin pills and creatine); whether they sought advice, and if so from whom, about their use of supplements; their experience of and attitudes towards drug testing; their views on the extent of the use of banned performance enhancing and recreational drugs in football; and their personal knowledge of players who used such drugs. Methods: With the cooperation of the Professional Footballers Association (PFA), reply paid postal questionnaires were delivered to the home addresses of all 2863 members of the PFA. A total of 706 questionnaires were returned, a response rate of just under 25%. Results: Many players use supplements, although almost one in five players does so without seeking qualified professional advice from anyone within the club. Blood tests are rarely used to monitor the health of players. One third of players had not been tested for drugs within the preceding two years, and 60% felt that they were unlikely to be tested in the next year. The use of performance enhancing drugs appears to be rare, although recreational drugs are commonly used by professional footballers: 6% of respondents indicated that they personally knew players who used performance enhancing drugs, and 45% of players knew players who used recreational drugs. Conclusions: There is a need to ensure that footballers are given appropriate advice about the use of supplements in order to minimise the risk of using supplements that may be contaminated with banned substances. Footballers are tested for drugs less often than many other elite athletes. This needs to be addressed. The relatively high level of recreational drug use is not reflected in the number of positive tests. This suggests that many players who use recreational drugs avoid detection. It also raises doubts about the ability of

  3. Academic-drug industry fellowships.

    PubMed

    Pleasants, D Z; Powell, J R; Johnston, J A; Eckel, F M; Cloutier, G; Cato, A E

    1987-01-01

    The UNC/BW fellowship, like other industry/academia collaborative fellowships, provides a unique training experience in clinical research. Both academia and the pharmaceutical industry have opened their doors and allowed clinical pharmacists to spend a year or more developing clinical research skills and an understanding of the drug development process. Is it worth it? Is this program a benefit to the individuals, to the sponsors, or to the profession of pharmacy? The survey of these fellows provides us with the individual's perspective on the benefit and quality of the fellowship. Most believed the fellowship provided them with training to meet their needs and interests. However, given this small number of individual opinions and comments, how do we determine whether the fellowship is meeting the original goal to train clinical pharmacists to be clinical researchers? By looking at the career paths of those who have completed the program, we may gain insight into whether the fellows are involved with research. Since the fellowship has been in existence for only six years, we really can look only at the initial placement of these clinical pharmacists. A majority have gained employment with clinical research responsibilities within the pharmaceutical industry. One measure of the research capabilities of these fellows is their contributions to the scientific literature; 10 papers and 3 abstracts have been generated by fellows since they completed their fellowships (Appendix I). As expected, the research contributions of the two-year fellows are greater than that of the one-year fellows. Seven one-year fellows did not have a publication.(ABSTRACT TRUNCATED AT 250 WORDS)

  4. Drug Information Residency Rotation with Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Cramer, Richard L.

    1986-01-01

    Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

  5. Drug Information Residency Rotation with Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Cramer, Richard L.

    1986-01-01

    Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

  6. Stategic trends in the drug industry.

    PubMed

    Drews, Jürgen

    2003-05-01

    The promise of genomics in drug discovery, which was eagerly embraced in the mid-1990s, has not yet been fulfilled. However, the influence of modern biology on drug discovery remains viable. The promise of genomics and biology should be put in context with the two central problems of drug discovery: the search for disease-related targets, and the study of drug-protein interactions and protein-protein interactions. The first tier of the biotechnology industry has now become the most productive segment of the drug industry. It combines a high degree of innovative spirit with solid pharmaceutical professionalism. Some biotechnology firms have succeeded in addressing unmet medical needs in technologically appealing ways. In their totality, these changes will deeply alter the nature and appearance of the drug industry.

  7. Energy and the English Industrial Revolution.

    PubMed

    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.

  8. Writing and Thinking about the English Industrial Revolution.

    ERIC Educational Resources Information Center

    Hedberg, Jacqueline H.

    1988-01-01

    Notes that writing can be a more effective tool for social studies learning if assignments require students to generate their own thoughts rather than restate someone else's ideas. Offers a two-day lesson on the reform of child labor practices during the English Industrial Revolution. A wide variety of writing activities are featured. (JDH)

  9. Bioremediation of industrial pharmaceutical drugs.

    PubMed

    Mansour, Hedi Ben; Mosrati, Ridha; Barillier, Daniel; Ghedira, Kamel; Chekir-Ghedira, Leila

    2012-07-01

    Recently, attention has been drawn toward the occurrence of pharmaceuticals in the environment. In recent years, many reports have been made on the occurrence of the large, differentiated group of pharmaceuticals in wastewater (PW), surface water, ground water, and in soil. The pharmaceutical sector is currently expanding in Tunisia, with more than 34 industries. The aim of this work was to evaluate the ability of Pseudomonas putida mt-2 to treat PW. P. putida was very efficient in reducing chemical oxygen demand (COD), total dissolved solids (TDS), and turbidity of solution (85.5, 89.1, and 81.5%, respectively). Genotoxicity of effluent, before and after biodegradation, was evaluated in vivo in mouse bone marrow by assessing the percentage of cells bearing different chromosome aberrations. Results indicated that PW showed a significant ability to induce DNA damage. In addition, PW induced a remarkable lipid peroxidation (LPO) effect, however, activities of both acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE) were unchanged when treated with PW, compared to nontreated PW. This toxicity was imputed to the presence of pharmaceutical compounds in wastewater. However, chromosome aberration, as well as LPO of PW, were significantly reduced after bioremediation. Thus, the use of this strain for testing on the industrial scale seems possible and advantageous.

  10. Drug-induced liver injury and drug development: industry perspective.

    PubMed

    Regev, Arie

    2014-05-01

    Despite intensive ongoing research, drug-induced live injury (DILI) remains a serious issue for care providers and patients, and has been a major cause of drug withdrawal and non-approval by regulatory authorities in the past 50 years. Consequently, DILI remains a major concern for the pharmaceutical industry and a leading cause for attrition during drug development. In most instances, severe DILI is an uncommon idiosyncratic reaction, which typically does not present during preclinical phases or early clinical phases of drug development. In the majority of cases, drugs that caused severe DILI in humans have not shown clear and consistent hepatotoxic signals in preclinical assessment including animal studies, cell cultures, or other methods. Despite intensive efforts to develop better biomarkers that would help in predicting DILI risk in earlier phases of drug development, such biomarkers are currently not supported by sufficient evidence and are not yet available for routine use by drug makers. Due to the lack of effective and accurate methods for prediction of idiosyncratic DILI during preclinical phases of drug development, different drug makers have adopted different approaches, which are often not supported by strong systematic evidence. Based on growing experience, it is becoming increasingly evident that milder forms of liver injury occurring during clinical development, when assessed correctly, may significantly enhance our ability to predict the drug's potential to cause more severe liver injury postmarketing. Strategies based on this concept have been adopted by many drug makers, and are being increasingly implemented during drug development. Meticulous causality assessment of individual hepatic cases and adherence to strict hepatic discontinuation rules are critical components of this approach and have to rely on thorough clinical evaluation and occasionally on assessment by liver experts experienced with DILI and drug development.

  11. 77 FR 58999 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  12. 78 FR 52931 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... to generic drug manufacturers to follow International Conference on Hamonisation (ICH)...

  13. The Triumph of the Industrial-Consumer Paradigm and English as the Global Language

    ERIC Educational Resources Information Center

    Spring, Joel

    2007-01-01

    This article considers the role of English as the global language within the industrial-consumer paradigm. In the 21st century, the English language plays a different function in the global economy than it did during the 19th century when it was used as an instrument of cultural imperialism. Today, English serves as a vehicle for participation in…

  14. The Triumph of the Industrial-Consumer Paradigm and English as the Global Language

    ERIC Educational Resources Information Center

    Spring, Joel

    2007-01-01

    This article considers the role of English as the global language within the industrial-consumer paradigm. In the 21st century, the English language plays a different function in the global economy than it did during the 19th century when it was used as an instrument of cultural imperialism. Today, English serves as a vehicle for participation in…

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

    ERIC Educational Resources Information Center

    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…

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

    PubMed

    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.

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

    PubMed

    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.

  18. 76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... HUMAN SERVICES Food and Drug Administration 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) is announcing the availability of a guidance for...

  19. 78 FR 37231 - Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing...

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

    ERIC Educational Resources Information Center

    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…

  1. Predicting drug efficacy: knockouts model pipeline drugs of the pharmaceutical industry.

    PubMed

    Zambrowicz, Brian P; Turner, C Alexander; Sands, Arthur T

    2003-10-01

    One of the major challenges for the pharmaceutical industry is to develop innovative drugs to new targets from the human genome. A systematic approach for target selection could significantly increase the rate of successful new drug development, thereby enhancing industry productivity. It has previously been shown that mouse knockout phenotypes for the targets of the 100 best-selling pharmaceutical drugs correlate well with known drug efficacy. Furthermore, physiological validation of novel pipeline targets of the pharmaceutical industry has been provided using mouse knockout data. These data demonstrate an excellent correlation between knockout phenotype and anticipated drug efficacy, establishing an important marker for superior new drug targets from the genome.

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

    PubMed

    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

  3. Engineering English and the High-Tech Industry: A Case Study of an English Needs Analysis of Process Integration Engineers at a Semiconductor Manufacturing Company in Taiwan

    ERIC Educational Resources Information Center

    Spence, Paul; Liu, Gi-Zen

    2013-01-01

    The global high-tech industry is characterized by extreme competitiveness, innovation, and widespread use of English. Consequently, Taiwanese high-tech companies require engineers that are talented in both their engineering and English abilities. In response to the lack of knowledge regarding the English skills needed by engineers in Taiwan's…

  4. Engineering English and the High-Tech Industry: A Case Study of an English Needs Analysis of Process Integration Engineers at a Semiconductor Manufacturing Company in Taiwan

    ERIC Educational Resources Information Center

    Spence, Paul; Liu, Gi-Zen

    2013-01-01

    The global high-tech industry is characterized by extreme competitiveness, innovation, and widespread use of English. Consequently, Taiwanese high-tech companies require engineers that are talented in both their engineering and English abilities. In response to the lack of knowledge regarding the English skills needed by engineers in Taiwan's…

  5. An Assessment of Drug Testing within the Construction Industry.

    ERIC Educational Resources Information Center

    Gerber, Jonathan K.; Yacoubian, George S., Jr.

    2002-01-01

    Investigates the efficacy of workplace drug-testing programs in reducing injury incident rates and workers' compensation experience-rating modification factors 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.…

  6. An Assessment of Drug Testing within the Construction Industry.

    ERIC Educational Resources Information Center

    Gerber, Jonathan K.; Yacoubian, George S., Jr.

    2002-01-01

    Investigates the efficacy of workplace drug-testing programs in reducing injury incident rates and workers' compensation experience-rating modification factors 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.…

  7. Drug discovery in pharmaceutical industry: productivity challenges and trends.

    PubMed

    Khanna, Ish

    2012-10-01

    Low productivity, rising R&D costs, dissipating proprietary products and dwindling pipelines are driving the pharmaceutical industry to unprecedented challenges and scrutiny. In this article I reflect on the current status of the pharmaceutical industry and reasons for continued low productivity. An emerging 'symbiotic model of innovation', that addresses underlying issues in drug failure and attempts to narrow gaps in current drug discovery processes, is discussed to boost productivity. The model emphasizes partnerships in innovation to deliver quality products in a cost-effective system. I also discuss diverse options to build a balanced research portfolio with higher potential for persistent delivery of drug molecules.

  8. Closing the drug lag for new drug submission and review in Japan: An industry perspective.

    PubMed

    Poirier, A F

    2015-11-01

    Previous publications have focused on drug lag in Japan and the government's initiatives to address the situation.(1) Japan is the third largest pharmaceutical market, and yet has experienced significant drug lag for many years. This article reviews the progress resulting from industry adaptation of new regulatory paradigms that include Japan in global drug development programs.

  9. The US drug safety system: role of the pharmaceutical industry.

    PubMed

    Gibson, Brent R; Suh, Ryung; Tilson, Hugh

    2008-02-01

    Despite increasingly strident calls for improved drug safety in the United States, recent events underscore the continuing gap among manufacturers, regulators, patients, and physicians. In the period leading to the recent Institute of Medicine report on the future of drug safety, representatives from industry were given an opportunity to provide input into this report. In light of continuing concerns about drug safety and pending legislation, this original perspective provides an important context. This work consolidates the views of representatives of individual pharmaceutical companies; the large industry trade associations, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) and the Biotechnology Industry Association (BIO); and those of the authors with regard to the industry role of drug safety in the United States. To ensure continued protection of the public's health, manufacturers must recognize themselves as critical to ensuring safe products; maintain corporate safety functions separate from marketing functions; provide oversight by a senior medical executive; engage in structured epidemiological research, risk assessment, and risk communication; and mandate the formation and maintenance of an internal, interdisciplinary, senior level safety council. The importance of aggressive and accountable drug safety will only become more salient as the public and their elected representatives demand better accountability from industry. Individual corporations now have the opportunity to move first to counter perceptions of profit over safety and to ensure that their business practices adequately protect the public's health. Copyright 2007 John Wiley & Sons, Ltd.

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

    PubMed

    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.

  11. Barriers to Alzheimer disease drug discovery and drug development in the pharmaceutical industry.

    PubMed

    Anand, Ravi

    2002-01-01

    The drug development process in the pharmaceutical industry has evolved from separate programs, specific for each country, into one coordinated, global development scheme. As a result, such a development program must meet regulatory requirements for all countries in which approval for the new drug will be sought. Barriers to Alzheimer disease (AD) drug discovery and development in the pharmaceutical industry can be categorized as (1) regulatory, (2) logistical, and (3) drug development issues. Some of the regulatory barriers could be overcome by international harmonization of guidelines for the development of antidementia drugs. The logistical issues can be reduced through international collaboration in the conduct of clinical studies, and the developmental issues can be addressed by using an expedited drug development plan that not only can reduce the time but also the resources required to develop the drug.

  12. Drug discovery: new models for industry-academic partnerships.

    PubMed

    Tralau-Stewart, Cathy J; Wyatt, Colin A; Kleyn, Dominique E; Ayad, Alex

    2009-01-01

    The re-focusing of pharmaceutical industry research away from early discovery activities is stimulating the development of novel models of drug discovery, notably involving academia as a 'front end'. In this article the authors explore the drivers of change, the role of new entrants (universities with specialised core facilities) and novel partnership models. If they are to be sustainable and deliver, these new models must be flexible and properly funded by industry or public funding, rewarding all partners for contributions. The introduction of an industry-like process and experienced management teams signals a revolution in discovery that benefits society by improving the value gained from publicly funded research.

  13. 76 FR 14024 - Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Hypertension Indication: Drug... for industry entitled ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims... are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive...

  14. English for Special Purposes in Business and Industry: Suggestions for Program Design.

    ERIC Educational Resources Information Center

    La Perla, Joann

    1988-01-01

    Examines the growing demand for English as a Second Language (ESL) programs in business and industry. Presents study findings on the characteristics of six ESL programs offered in Fortune 500 companies, identifying factors that commonly facilitate or impede ESL program design. (DMM)

  15. Expanding Economic and Industrial Understanding through History and Technology in an English Primary School.

    ERIC Educational Resources Information Center

    Coates, David; Taylor, Paul

    1996-01-01

    Describes a joint history-technology project undertaken with ten- and eleven-year-old students in an English primary school with a view to developing the cross-curricular theme of Economic and Industrial Understanding (EIU). Outlines the classroom course and discusses the principles of EIU in relation to the British National Curriculum. (DSK)

  16. Industrial Prep, Volume Five, Senior Year--English, Chemistry, Social Studies, and Occupational Relations.

    ERIC Educational Resources Information Center

    Hackensack Public Schools, NJ.

    This 12th Grade teaching guide presents four units in industrial preparation for vocational students which serve as a general and specific vocational basis either for immediate post-secondary employment or for further formal technical education. The five diverse English curriculum units range from vocational preparation and chemistry topics to…

  17. Drug development: how academia, industry and authorities interact.

    PubMed

    Garattini, Silvio; Perico, Norberto

    2014-10-01

    Unfortunately, abundant examples could be given of pitfalls in the current drug development paradigm-including in the design, conduct and evaluation of phase III clinical trials. This article discusses issues of particular relevance to clinical trials in nephrology, including the inappropriate use of placebo, publication of reports that emphasize potential treatment benefits over adverse reactions, the sometimes dubious impartiality of independent guidelines, and inadequate recruitment of elderly patients. This Perspectives article aims to highlight and summarize the flaws in the current drug development process, while suggesting a way forward that equally satisfies the requirements of academia, patients and the pharmaceutical industry. We suggest improvements to the drug development process and related legislation that intend to balance public needs with commercial aims and ensure effective drug evaluation by regulatory authorities.

  18. 75 FR 47604 - Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration (formerly 2003D-0571) Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

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

    PubMed

    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.

  20. Herbal Drug Regulation and Commercialization: An Indian Industry Perspective

    PubMed Central

    Manchikanti, Padmavati

    2013-01-01

    Abstract Objectives: To assess the constraints for Indian herbal drug industry with respect to manufacturing and commercialization of herbal medicines. Methods: 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. Results: 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. Conclusions: 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. PMID:23829812

  1. [Veterinary Drug 'what'? Various marginal notes by an 'industrial veterinarian'].

    PubMed

    Hoftijzer, J

    1987-04-15

    A retrospective view of the history of the Veterinary Medicinal Products Act and the current situation of the trade in veterinary drugs is followed by a discussion of a number of changes which will have to be made in the fields of production, packing, distribution and the trade in these drugs. With regard to these last-named items, a connection with the Act on the Practice of Veterinary Medicine should be made. In general it can be stated that the innovating industry is not dissatisfied, but only the actual enforcement of the act will provide genuine replies to questions which are still unanswered.

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed Central

    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. PMID:27313529

  5. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Rheumatoid Arthritis... guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.'' This... of patients with rheumatoid arthritis (RA). It also addresses additional considerations for...

  6. 75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration 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 Administration (FDA) is announcing the availability of a...

  7. 78 FR 78366 - Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Naming of Drug Products Containing Salt Drug Substances.'' The United States Pharmacopeial (U.S.P.) Convention has adopted a monograph naming policy that changed the nomenclature for compendial drug products that contain a salt. Under the new policy, drug names and strengths for......

  8. An industry statistician's perspective on PHC drug development.

    PubMed

    Fridlyand, Jane; Yeh, Ru-Fang; Mackey, Howard; Bengtsson, Thomas; Delmar, Paul; Spaniolo, Greg; Lieberman, Grazyna

    2013-11-01

    In the past decade, the cost of drug development has increased significantly. The estimates vary widely but frequently quoted numbers are staggering-it takes 10-15 years and billions of dollars to bring a drug to patients. To a large extent this is due to many long, expensive and ultimately unsuccessful drug trials. While one approach to combat the low yield on investment could be to continue searching for new blockbusters, an alternative method would lead us to focus on testing new targeted treatments that have a strong underlying scientific rationale and are more likely to provide enhanced clinical benefit in population subsets defined by molecular diagnostics. Development of these new treatments, however, cannot follow the usual established path; new strategies and approaches are required for the co-development of novel therapeutics and the diagnostic. In this paper we will review, from the point of view of industry, the approaches to, and challenges of drug development strategies incorporating predictive biomarkers into clinical programs. We will outline the basic concepts behind co-development with predictive biomarkers and summarize the current regulatory paradigm. We will present guiding principles of personalized health care (PHC) development and review the statistical, strategic, regulatory and operational challenges that statisticians regularly encounter on development programs with a PHC component. Some practical recommendations for team statisticians involved in PHC drug development are included. The majority of the examples and recommendations are drawn from oncology but broader concepts apply across all therapeutic areas.

  9. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial..., Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators..., Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.'' This guidance is intended to...

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

    PubMed

    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.

  11. 77 FR 11133 - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... Infections: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Complicated Urinary Tract Infections: Developing Drugs for Treatment... treatment of complicated urinary tract infections (cUTIs). Specifically, this guidance addresses...

  12. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY...

  13. Alcohol and Drug Prevention Curriculum Resource Guide Grades 10-12: Communication Skills--English IV.

    ERIC Educational Resources Information Center

    North Carolina State Dept. of Public Instruction, Raleigh. Alcohol and Drug Defense Program.

    This curriculum resource guide on alcohol and drug prevention provides suggested activities for teachers of grades 10 through 12. Four integrated learning activities for communication skills/ English IV and healthful living are presented. Communication skills/literature goals include experiencing young adult literature, using effective techniques…

  14. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... six of them from the premarket notification requirements of the Federal Food, Drug, and Cosmetic...

  15. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Federal Food, Drug, and Cosmetic Act (the FD&C Act), procedural information on how to fulfill section...

  16. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  17. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...] [FR Doc No: 2011-28766] 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...

  18. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... educate regulated industry and FDA Staff on how, when, and why to use classification product codes for... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration...

  19. 76 FR 58018 - Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Selection Studies for... entitled ``Self-Selection Studies for Nonprescription Drug Products.'' The draft guidance is intended to provide recommendations to industry on the design of self- selection studies for nonprescription drug...

  20. Drug-drug interaction studies: regulatory guidance and an industry perspective.

    PubMed

    Prueksaritanont, Thomayant; Chu, Xiaoyan; Gibson, Christopher; Cui, Donghui; Yee, Ka Lai; Ballard, Jeanine; Cabalu, Tamara; Hochman, Jerome

    2013-07-01

    Recently, the US Food and Drug Administration and European Medicines Agency have issued new guidance for industry on drug interaction studies, which outline comprehensive recommendations on a broad range of in vitro and in vivo studies to evaluate drug-drug interaction (DDI) potential. This paper aims to provide an overview of these new recommendations and an in-depth scientifically based perspective on issues surrounding some of the recommended approaches in emerging areas, particularly, transporters and complex DDIs. We present a number of theoretical considerations and several case examples to demonstrate complexities in applying (1) the proposed transporter decision trees and associated criteria for studying a broad spectrum of transporters to derive actionable information and (2) the recommended model-based approaches at an early stage of drug development to prospectively predict DDIs involving time-dependent inhibition and mixed inhibition/induction of drug metabolizing enzymes. We hope to convey the need for conducting DDI studies on a case-by-case basis using a holistic scientifically based interrogative approach and to communicate the need for additional research to fill in knowledge gaps in these areas where the science is rapidly evolving to better ensure the safety and efficacy of new therapeutic agents.

  1. 77 FR 35689 - Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... Evaluation of Drugs for Treatment; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Drugs for...

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

    NASA Astrophysics Data System (ADS)

    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.

  3. The role of modern biology and medicine in drug development in academia and industry.

    PubMed

    Blake, Charles A; Barker, Kenneth L; Sobel, Burton E

    2006-12-01

    This symposium addresses careers in drug development in industry; the performance of translational research by academia, industry, and both; and numerous factors pertinent to alliances essential to drug discovery and development. Drug development is a complex process that regularly involves effective collaborations between academic and physician scientists and industry. There are specific occupational factors affecting recruitment of scientists and physicians in drug development programs in industry; ideal backgrounds for successful applicants for positions in industry in drug development; ethical and regulatory considerations particularly germane to the performance of scientists and physicians in drug development programs in industry and at universities; and particular gratifications available to scientists in industry working on drug development. Both similarities and differences characterize the performance of translational research in industry compared with academia. In industry, logistic, operational, and scientific oversight is complex, especially because it often involves relationships with clinical enterprises outside of the corporation. The process is long and arduous from formulation of a good idea in discovery to acceptance of a novel drug in the marketplace. Collaborations and partnerships by industry often involving academia and confrontation of multiple issues are pivotal.

  4. 77 FR 67379 - Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Highly...

  5. 75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... HUMAN SERVICES Food and Drug Administration (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. ACTION: Notice. SUMMARY: The Food and Drug...

  6. 75 FR 45641 - Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  7. 76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Treatment of Urinary Incontinence.'' This guidance document describes FDA's recommendations for clinical...

  8. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration 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. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... 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... about the potential adverse health effects from the use of powder on medical gloves and is...

  10. 75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Researchers on the Radioactive...) is announcing the availability of a guidance for industry and researchers entitled ``The Radioactive... guidance provides information to those using radioactive drugs for certain research purposes to help...

  11. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-24

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... the industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are... HUD designations may be eligible for marketing approval under the Humanitarian Device Exemption...

  12. 78 FR 21611 - Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Self-Selection Studies for... entitled ``Self-Selection Studies for Nonprescription Drug Products.'' This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application...

  13. 77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to... safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User...

  14. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration 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. SUMMARY: The Food and Drug Administration (FDA)...

  15. 77 FR 18828 - Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... Novo Classifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance document... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration...

  16. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... HUMAN SERVICES Food and Drug Administration 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 and Drug Administration (FDA) is announcing...

  17. 78 FR 12760 - Guidance for Industry on Labeling for Human Prescription Drug and Biological Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling for Human Prescription Drug and Biological Products--Implementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The......

  18. 78 FR 31943 - Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good... for the manufacturing of drugs. This draft guidance is being issued consistent with FDA's good... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Contract...

  19. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... HUMAN SERVICES Food and Drug Administration 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 Administration, HHS. ACTION: Notice; reopening of comment period...

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

    ERIC Educational Resources Information Center

    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…

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

    ERIC Educational Resources Information Center

    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. Drug packaging in 2015: risky industry choices and lax regulation.

    PubMed

    2016-06-01

    Prescrire examined the packaging quality of 240 drugs in 2015. No new advances were identified, but drug packaging continues to expose patients to a variety of dangers. Some past advances persist: for example, INNs are often more legible, and recent patient leaflets tend to be clearer and more informative. But these measures are not applied to all drugs, and are rarely applied retroactively to older drugs. The overall picture in 2015 is that many drugs are difficult to identify, risky or downright dangerous to prepare, or supplied with patient leaflets that fail to correctly inform patients about their medication. And measures to prevent drug poisoning in children need to be completely rethought. It is high time for regulators and policy makers to take the issue of drug packaging seriously, so blatant are the signs of their failure to do so: the increasing use of bulk bottles for new drugs; failure to implement guidelines on safe drug packaging (unit-dose presentations, appropriate dosing devices, etc.); and expanding umbrella brands which, given the dangers they pose to patients, should be banned instead. All things considered, healthcare professionals and patients must remain vigilant and report any dangers they identify. A major European initiative on drug packaging is becoming increasingly necessary.

  3. Work-related injuries in a state trauma registry: relationship between industry and drug screening.

    PubMed

    Bunn, Terry L; Slavova, Svetla; Bernard, Andrew C

    2014-08-01

    Work-related injuries exert a great financial and economic burden on the US population. The study objectives were to identify the industries and occupations associated with worker injuries and to determine the predictors for injured worker drug screening in trauma centers. Work-related injury cases were selected using three criteria (expected payer source of workers' compensation, industry-related e-codes, and work-related indicator) from the Kentucky Trauma Registry data set for years 2008 to 2012. Descriptive analyses and multiple logistic regression were performed on the work-related injury cases. The "other services" and construction industry sectors accounted for the highest number of work-related cases. Drugs were detected in 55% of all drug-screened work-related trauma cases. Higher percentages of injured workers tested positive for drugs in the natural resources and mining, transportation and public utilities, and construction industries. In comparison, higher percentages of injured workers in the other services as well as transportation and public utilities industries were drug screened. Treatment at Level I trauma centers and Glasgow Coma Scale (GCS) scores indicating a coma or severe brain injury were both significant independent predictors for being screened for drugs; industry was not a significant predictor for being drug screened. The injured worker was more likely to be drug screened if the worker had a greater than mild injury, regardless of whether the worker was an interfacility transfer. These findings indicate that there may be elevated drug use or abuse in natural resources and mining, transportation and public utilities, as well as construction industry workers; improved identification of the specific drug types in positive drug screen results of injured workers is needed to better target prevention efforts. Epidemiologic study, level III.

  4. Natural products and drug discovery: a survey of stakeholders in industry and academia

    PubMed Central

    Amirkia, Vafa; Heinrich, Michael

    2015-01-01

    Context: In recent decades, natural products have undisputedly played a leading role in the development of novel medicines. Yet, trends in the pharmaceutical industry at the level of research investments indicate that natural product research is neither prioritized nor perceived as fruitful in drug discovery programmes as compared with incremental structural modifications and large volume HTS screening of synthetics. Aim: We seek to understand this phenomenon through insights from highly experienced natural product experts in industry and academia. Method: We conducted a survey including a series of qualitative and quantitative questions related to current insights and prospective developments in natural product drug development. The survey was completed by a cross-section of 52 respondents in industry and academia. Results: One recurrent theme is the dissonance between the perceived high potential of NP as drug leads among individuals and the survey participants' assessment of the overall industry and/or company level strategies and their success. The study's industry and academic respondents did not perceive current discovery efforts as more effective as compared with previous decades, yet industry contacts perceived higher hit rates in HTS efforts as compared with academic respondents. Surprisingly, many industry contacts were highly critical to prevalent company and industry-wide drug discovery strategies indicating a high level of dissatisfaction within the industry. Conclusions: These findings support the notion that there is an increasing gap in perception between the effectiveness of well established, commercially widespread drug discovery strategies between those working in industry and academic experts. This research seeks to shed light on this gap and aid in furthering natural product discovery endeavors through an analysis of current bottlenecks in industry drug discovery programmes. PMID:26578954

  5. 78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ... Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability... ``Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug... Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff,'' you may either...

  6. Perception of various stakeholders regarding clinical drug trial industry in India.

    PubMed

    Parikh, Rakesh M; Pandia, Kirti; Goyal, Mahesh; Sharma, Meenakshi; Dolima, M S

    2011-07-01

    Though India has been thought to be an ideal destination for conduct of clinical drug trials, other smaller countries seem to be doing better. The pace of growth observed during 2005-2009 seems to be plateaued in 2010. There is an urgent need for introspection and corrective actions. An online survey was conducted among various stakeholders from clinical drug trial industry in India regarding their perception about clinical drug trial industry in India. Respondents were requested to rate training of investigator sites, industry, performance of regulatory, etc. Majority of respondent felt that the clinical drug trial industry in India is growing, though India is not utilizing its full potential. Lack of trained investigators and delay in regulatory approvals came out as biggest hurdles. Urgent steps need to be taken in terms of proper training of all stakeholders. Regulatory bodies ought to bring about some radical changes in the system so as to match the other competing nations.

  7. 77 FR 57094 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-17

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations; Availability; Correction AGENCY: Food and Drug... announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities, Sites...

  8. 76 FR 59705 - Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  9. 76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and...

  10. Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective.

    PubMed

    Jones, H M; Chen, Y; Gibson, C; Heimbach, T; Parrott, N; Peters, S A; Snoeys, J; Upreti, V V; Zheng, M; Hall, S D

    2015-03-01

    The application of physiologically based pharmacokinetic (PBPK) modeling has developed rapidly within the pharmaceutical industry and is becoming an integral part of drug discovery and development. In this study, we provide a cross pharmaceutical industry position on "how PBPK modeling can be applied in industry" focusing on the strategies for application of PBPK at different stages, an associated perspective on the confidence and challenges, as well as guidance on interacting with regulatory agencies and internal best practices.

  11. Recreational drug use within the employees of the mariculture and seafood industry in South Australia.

    PubMed

    Evans, Alan R; Tait, Russell; Harvey, Peter; Newbury, Jonathan

    2005-01-01

    A study of recreational drug use among workers in the Port Lincoln mariculture and seafood industries was conducted by self report questionnaire. High rates of cannabis and alcohol use were revealed during the shore based fish farming season. The occupational health and safety implications of these findings in one of Australia's most dangerous industries are significant. Further research could inform the development of industry specific harm minimisation policies.

  12. 77 FR 60126 - Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    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... treatment of acute bacterial otitis media (ABOM). This guidance finalizes the revised draft guidance of...

  13. Co-operation between patient organisations and the drug industry in Finland.

    PubMed

    Hemminki, Elina; Toiviainen, Hanna K; Vuorenkoski, Lauri

    2010-04-01

    The aim of the study was to investigate the co-operation between patient organizations and the drug industry in Finland prior to critical discussions on the topic. The data were gathered by a questionnaire survey of 85 patient organisations (response rate 65%, n = 55) and 20 drug firms (response rate 100%) in 2003, and by interviewing 13 organisations and surveying their web-pages and other documents in 2004. In the surveys, half of the patient organisations and 80% of the drug firms considered co-operation important. Most (71%) organisations reported financial support from the drug industry. Most organisations and drug firms had experienced problems. Common problems for organisations were too little or too unpredictable support from industry, and threats to independence and objectivity. Drug firms frequently mentioned unclear rules of co-operation. The patient organisation interviews exhibited similar themes and findings to those found in the surveys, revealing the complexity and importance of co-operation in organisation activities, and the variation between organisations. This case study from Finland showed that co-operation between patient organizations and the drug industry was common, many-sided and not usually transparent. The close connections between patient organizations and commercial companies, particularly drug firms, raise several policy issues and the need for action. Copyright 2010 Elsevier Ltd. All rights reserved.

  14. 76 FR 55927 - Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked... the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.''...

  15. 75 FR 70011 - Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-16

    ... approved accreditation body and certified by the Secretary of Health and Human Services (the Secretary) or... HUMAN SERVICES Food and Drug Administration Guidance for Industry, Mammography Quality Standards Act...: Modifications and Additions to Policy Guidance Help System 13; Availability AGENCY: Food and Drug...

  16. The path to oncology drug target validation: an industry perspective.

    PubMed

    Cortés-Cros, Marta; Schmelzle, Tobias; Stucke, Volker M; Hofmann, Francesco

    2013-01-01

    The advent of a variety of genomic, proteomic and other system-based scientific approaches has raised the expectations of identifying novel targets for oncology drug discovery. However, the complexity of human genome cancer alterations requires a careful analysis of the function of candidate targets identified by these efforts. The postulation and testing of a hypothesis that modulation of a protein or pathway will result in a therapeutic effect in a preclinical setting is crucial for target validation activities. In this chapter, we provide an overview on target identification and validation approaches to interrogate the functional and therapeutic relevance of a candidate cancer drug target as an essential step towards justifying the subsequent investment in drug discovery efforts.

  17. Industrial Prep, Volume Three, Junior Year--Contents: Physics and English.

    ERIC Educational Resources Information Center

    Hackensack Public Schools, NJ.

    This Grade 11 teaching guide contains two curriculums which focus on 10 team physics projects and five thematic units in English. The 10 group physics projects are derived from the application of three laboratory units on the properties of matter, mechanics, and electricity. The outlined English curriculum ranges from such specifically pragmatic…

  18. Radiopharmaceuticals for oncology drug development: a pharmaceutical industry perspective.

    PubMed

    Murphy, Philip S; Bergström, Mats

    2009-01-01

    Oncology remains an increasingly important focus of therapeutic development yet there remain many scientific and operational bottlenecks to deliver optimum treatments efficiently. Radiopharmaceuticals constitute a group of methodologies able to support the many stages of drug development. Methods such as [(18)F]-FDG-PET continue to have a role, evaluating early metabolic response to treatment and supporting more conventional assessments of disease response. Improvements over such tracers (for example, use of [(18)F]-FLT) in certain settings can also widen the impact radiotracers have on clinical development. New categories of tracers able to provide molecular insight into therapeutic intervention are likely grow and aim to remove the ambiguity of how effective a new drug is. It is likely that newer tracers able to define processes such as angiogenesis and apoptosis will supplement other methods in supporting early development decision-making and de-risking expensive, late-stage programs. Labeled drugs themselves also offer the ability to study localised pharmacokinetics in vivo and study issues such as therapeutic combinations. Owing to the significant cost, resource and time investment in developing novel tracers, new opportunities need to be closely matched with emerging drug development needs.

  19. Toward allocative efficiency in the prescription drug industry.

    PubMed

    Guell, R C; Fischbaum, M

    1995-01-01

    Traditionally, monopoly power in the pharmaceutical industry has been measured by profits. An alternative method estimates the deadweight loss of consumer surplus associated with the exercise of monopoly power. Although upper and lower bound estimates for this inefficiency are far apart, they at least suggest a dramatically greater welfare loss than measures of industry profitability would imply. A proposed system would have the U.S. government employing its power of eminent domain to "take" and distribute pharmaceutical patents, providing as "just compensation" the present value of the patent's expected future monopoly profits. Given the allocative inefficiency of raising taxes to pay for the program, the impact of the proposal on allocative efficiency would be at least as good at our lower bound estimate of monopoly costs while substantially improving efficiency at or near our upper bound estimate.

  20. 76 FR 46303 - Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    ...: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord... Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood... manipulated hematopoietic stem/progenitor cells from placental/ umbilical cord blood, from an unrelated...

  1. Drug-drug interactions related to altered absorption and plasma protein binding: theoretical and regulatory considerations, and an industry perspective.

    PubMed

    Hochman, Jerome; Tang, Cuyue; Prueksaritanont, Thomayant

    2015-03-01

    Drug-drug interactions (DDIs) related to altered drug absorption and plasma protein binding have received much less attention from regulatory agencies relative to DDIs mediated via drug metabolizing enzymes and transporters. In this review, a number of theoretical bases and regulatory framework are presented for these DDI aspects. Also presented is an industry perspective on how to approach these issues in support of drug development. Overall, with the exception of highly permeable and highly soluble (BCS 1) drugs, DDIs related to drug-induced changes in gastrointestinal (GI) physiology can be substantial, thus warranting more attentions. For a better understanding of absorption-associated DDI potential in a clinical setting, mechanistic studies should be conducted based on holistic integration of the pharmaceutical profiles (e.g., pH-dependent solubility) and pharmacological properties (e.g., GI physiology and therapeutic margin) of drug candidates. Although majority of DDI events related to altered plasma protein binding are not expected to be of clinical significance, exceptions exist for a subset of compounds with certain pharmacokinetic and pharmacological properties. Knowledge of the identity of binding proteins and the binding extent in various clinical setting (including disease states) can be valuable in aiding clinical DDI data interpretations, and ensuring safe and effective use of new drugs.

  2. 76 FR 22903 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Request AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... February 15, 2007'' to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate...

  3. 75 FR 15440 - Guidance for Industry on Standards for Securing the Drug Supply Chain-Standardized Numerical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

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

    PubMed

    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'.

  5. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Solvents in Animal... guidance for industry 211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers... Chapter Residual Solvents that applies to both human and veterinary drugs and to compendial and...

  6. 78 FR 63220 - Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Acute Bacterial Skin and Skin... guidance for industry entitled ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for... drugs to treat acute bacterial skin and skin structure infections (ABSSSI). This guidance finalizes the...

  7. Peering into the pharmaceutical "pipeline": investigational drugs, clinical trials, and industry priorities.

    PubMed

    Fisher, Jill A; Cottingham, Marci D; Kalbaugh, Corey A

    2015-04-01

    In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry's investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding--and often problematic--role of pharmaceuticals in society. To access the pharmaceutical industry's pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2477 different drugs in 4182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline was being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered.

  8. Attributable risk of alcohol and other drugs for crashes in the transit industry.

    PubMed

    Cunradi, C B; Ragland, D R; Greiner, B; Klein, M; Fisher, J M

    2005-12-01

    To estimate the impact of employee alcohol and drug use on crashes in the transit industry from 1995-2000. Secondary analysis of federally mandated post crash and random alcohol and drug testing results. The US transit industry. Transit industry employees. Relative risk (RR), population attributable risk (PAR), and population attributable risk percentage (PAR%). For alcohol testing, the estimated PAR% ranged from 0.02% (1999) to 0.03% (1995). For drug testing, the estimated PAR% ranged from 0.38% (1998) to 0.67% (1997). Based on these calculations, the estimated number of crashes per 1000 crashes attributable to alcohol was less than one during 1995-2000, and the number attributable to drugs ranged from about four to about six. The number of crashes attributable to either alcohol or drugs did not vary greatly from 1995-2000. Estimated rates of crashes attributable to alcohol or drugs were substantially lower in 1995, the first year of testing, than had been projected based on previous estimates, and did not show substantial change from 1995-2000. Approaches to transit safety based on reducing employee use of alcohol and other drugs have modest potential for reducing number of fatalities, injuries, and crashes.

  9. Attributable risk of alcohol and other drugs for crashes in the transit industry

    PubMed Central

    Cunradi, C; Ragland, D; Greiner, B; Klein, M; Fisher, J

    2005-01-01

    Objective: To estimate the impact of employee alcohol and drug use on crashes in the transit industry from 1995–2000. Design: Secondary analysis of federally mandated post crash and random alcohol and drug testing results. Setting: The US transit industry. Subjects: Transit industry employees. Main outcome measures: Relative risk (RR), population attributable risk (PAR), and population attributable risk percentage (PAR%). Results: For alcohol testing, the estimated PAR% ranged from 0.02% (1999) to 0.03% (1995). For drug testing, the estimated PAR% ranged from 0.38% (1998) to 0.67% (1997). Based on these calculations, the estimated number of crashes per 1000 crashes attributable to alcohol was less than one during 1995–2000, and the number attributable to drugs ranged from about four to about six. The number of crashes attributable to either alcohol or drugs did not vary greatly from 1995–2000. Estimated rates of crashes attributable to alcohol or drugs were substantially lower in 1995, the first year of testing, than had been projected based on previous estimates, and did not show substantial change from 1995–2000. Conclusions: Approaches to transit safety based on reducing employee use of alcohol and other drugs have modest potential for reducing number of fatalities, injuries, and crashes. PMID:16326775

  10. Petroleum Refining, Industrial Chemical, Drug, and Paper and Allied Products Industries. Reprinted from the Occupational Outlook Handbook, 1978-79 Edition.

    ERIC Educational Resources Information Center

    Bureau of Labor Statistics (DOL), Washington, DC.

    Focusing on occupations in refining and industrial chemical, drug, and paper manufacturing industries, this document is one in a series of forty-one reprints from the Occupational Outlook Handbook providing current information and employment projections for individual occupations and industries through 1985. The specific occupations covered in…

  11. Regulating drug information in Europe: a pyrrhic victory for pharmaceutical industry critics?

    PubMed

    Mulinari, Shai

    2013-06-01

    Informed by recent sociological debates on pharmaceuticalisation, this article examines the evolution of the current EU legal proposal on prescription drug information to patients, as well as the surrounding controversies. In 2008 the European Commission proposed the relaxation of the existing rules governing drug information provision to patients by the pharmaceutical industry. Critics of the industry's influence over health policy and markets, including consumer organisations, industry-independent patient organisations and health professionals, rejected the Commission's proposal, claiming that the industry cannot be considered a reliable source of patient information due to inherent financial conflicts of interest. Since these critics were at least partially successful in rallying opinion against the Commission proposal, they functioned as countervailing forces to promotion-driven pharmaceuticalisation. Even so, as a watered-down version of the proposal moved through the European Parliament it was further modified to ultimately resemble the Swedish system that was held up as a high-quality example of industry-based information provision. Yet this article contends that the Swedish system displays evidence of corporate bias. Significantly, basing EU policy on a drug information system not resistant to corporate bias risks creating practices that violate the legally mandated mission of EU drug regulation, which is to 'promote and protect public health'.

  12. [PHARMACEUTICAL INDUSTRY AND PERSONALIZED MEDICINE: A PARADIGM SHIFT IN THE DEVELOPMENT OF NEW DRUGS].

    PubMed

    Scheen, A J

    2015-01-01

    The cost of pharmacotherapy is increasing in the health care budget. The pharmaceutical industry is facing the exhaustion of medications that are largely prescribed and have a high profitability (blockbusters). Because of patient heterogeneity, there is a great interindividual variability of the responses to drug therapy. Thus, it is essential to better detect potential to avoid waste of resources resulting from the prescription of expensive drugs to poor responders. The development of personalized medicine, or precision medicine, certainly offers opportunities to the pharmaceutical industry, but also exposes it to new big challenges.

  13. Industry invites regulation: the passage of the Pure Food and Drug Act of 1906.

    PubMed Central

    Barkan, I D

    1985-01-01

    Ending its 27-year stranglehold on proposals for federal pure food and drug legislation, Congress passed the Pure Food and Drug Act and its companion bill, the Meat Inspection Act, on June 30, 1906. An unprecedented convergence of consumer, scientific, and industrial support in 1906 prompted such action; most industries even planned for it, hoping regulation would restore the competitiveness of their products on weak foreign and domestic markets. The ways in which these interests converged, and the reasons therefore, suggest a change in their relationships to each other and with the federal government as America headed into the twentieth century. Images p21-a p21-b PMID:3881052

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

    SciTech Connect

    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.

  15. Barriers to Alzheimer disease drug discovery and development in the biotechnology industry.

    PubMed

    Altstiel, L D

    2002-01-01

    The major barrier to Alzheimer disease (AD) drug discovery and development in the biotechnology industry is scale. Most biotechnology companies do not have the personnel or expertise to carry a drug from the bench to the market. Much effort in the industry has been directed toward the elucidation of molecular mechanisms of AD and the identification of new targets. Advances in biotechnology have generated new insights into disease mechanisms, increased the number of lead compounds, and accelerated biologic screening. The majority of costs associated with drug development are in clinical testing and development activities, many of which are driven by regulatory issues. For most biotechnology companies, the costs of such trials and the infrastructure necessary to support them are prohibitive. Another significant barrier is the definition of therapeutic benefit for AD drugs; Food and Drug Administration (FDA) precedent has established that a drug must show superiority to placebo on a performance-based test of cognition and a measure of global clinical function. This restrictive definition is biased toward drugs that enhance performance on memory-based tests. Newer AD drugs are targeted toward slowing disease progression; however, there is currently no accepted definition of what constitutes efficacy in disease progression. Despite these obstacles, the biotechnology industry has much to offer AD drug discovery and development. Biotechnology firms have already developed essential technology for AD drug development and will continue to do so. Biotechnology companies can move more quickly; of course, the trick is to move quickly in the right direction. Speed may offset some of the problems associated with lack of scale. Additionally, biotechnology companies can afford to address markets that may be too restricted for larger pharmaceutical companies. This advantage will have increasing importance, as therapies are developed to address subtypes of AD.

  16. 75 FR 73108 - Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... degradation products and updates the draft guidance ``ANDAs: Impurities in Drug Products'' announced in... final guidance to: (1) Update information on listing of degradation products, setting acceptance criteria, and qualifying degradation products (thresholds and procedures) in abbreviated new...

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

    ERIC Educational Resources Information Center

    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…

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

    ERIC Educational Resources Information Center

    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…

  19. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration 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 Food and Drug Administration (FDA) is announcing...

  20. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... for the Topical Approximation of Skin; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  1. 76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-14

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... subject to comment in accordance with the Agency's good guidance practices. DATES: Submit...

  2. 76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... subject to comment in accordance with the Agency's good guidance practices. DATES: Submit...

  3. 77 FR 32124 - Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... Evaluation of Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment.'' This guidance is intended to assist the pharmaceutical industry and investigators who are developing drugs for the...

  4. 78 FR 38349 - Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  5. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  6. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... HUMAN SERVICES Food and Drug Administration 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 of comment period. SUMMARY: The Food and Drug Administration (FDA...

  7. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration 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 Administration (FDA) is announcing the availability of the...

  8. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration 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 and Drug Administration (FDA) is announcing the...

  9. 78 FR 60292 - Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Application Submissions--Refuse-to-Receive Standards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  10. 76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... document is immediately in effect as the special control for the ovarian adnexal mass assessment score...

  11. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ...] [FR Doc No: 2012-15025] 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...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  12. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... HUMAN SERVICES Food and Drug Administration 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. ] SUMMARY: The Food and Drug Administration (FDA) is...

  13. 78 FR 20116 - Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement International Organization for Standardization Standard 11040-4; Availability AGENCY: Food and Drug...

  14. 76 FR 44935 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ...] [FR Doc No: 2011-18923] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0453] Draft Guidance for Industry and Food and Drug Administration Staff; 510(k... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

  15. 76 FR 69274 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-08

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. SUMMARY: The Food and Drug Administration (FDA) is reopening until November 28...

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

    SciTech Connect

    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. Perception of various stakeholders regarding clinical drug trial industry in India

    PubMed Central

    Parikh, Rakesh M.; Pandia, Kirti; Goyal, Mahesh; Sharma, Meenakshi; Dolima, M. S.

    2011-01-01

    Context: Though India has been thought to be an ideal destination for conduct of clinical drug trials, other smaller countries seem to be doing better. The pace of growth observed during 2005-2009 seems to be plateaued in 2010. Aims: There is an urgent need for introspection and corrective actions. Materials and Methods: An online survey was conducted among various stakeholders from clinical drug trial industry in India regarding their perception about clinical drug trial industry in India. Respondents were requested to rate training of investigator sites, industry, performance of regulatory, etc. Results: Majority of respondent felt that the clinical drug trial industry in India is growing, though India is not utilizing its full potential. Lack of trained investigators and delay in regulatory approvals came out as biggest hurdles. Conclusions: Urgent steps need to be taken in terms of proper training of all stakeholders. Regulatory bodies ought to bring about some radical changes in the system so as to match the other competing nations. PMID:21897882

  18. 76 FR 41803 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-15

    ... Differentiation of Influenza Viruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Differentiation of Influenza Viruses.'' FDA is issuing this guidance to inform industry and Agency staff of its... diagnostic devices intended for the detection or detection and differentiation of influenza viruses. DATES...

  19. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ... draft guidance, when finalized, is intended to provide guidance to industry for designing and conducting clinical effectiveness studies, and describes criteria that the Center for Veterinary Medicine (CVM) thinks... represent the Agency's current thinking on evaluating the effectiveness of anticoccidial drugs in food...

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

    PubMed Central

    2017-01-01

    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. PMID:28875019

  1. English Teaching Profile: Bahrain

    ERIC Educational Resources Information Center

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

    A profile of the state of English and English instruction in Bahrain covers the following topics: description of the role and status of English language use in industry and commerce, government, and education; the role of English at all levels of the educational system; the availability, characteristics, and qualifications of teachers of English;…

  2. The politics of access to expensive drugs: INESSS and the innovative pharmaceutical industry.

    PubMed

    Hughes, David

    2012-05-01

    The innovative pharmaceutical industry employs thousands of people in Quebec and so has the ability to exert strong political pressure; the public statements of Sanofi-Aventis concerning the provincial reimbursement of certain expensive drugs are an example. "Maintaining a dynamic biopharmaceutical industry" is one of four main axes of the drug policy of Quebec's ministry of health. However, this role of government should not take precedence over the efficient and equitable management of health resources. We defend the legitimate and responsible choice of the Institut national d'excellence en santé et en services sociaux du Québec (INESSS) to require an acceptable cost-effectiveness ratio from expensive new drugs.

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

    PubMed

    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.

  4. [Is it pertinent to investigate the relations between physicians and the drug industry].

    PubMed

    Moliner, Javier; Mozota, Julián; Abad, José María; Casaña, Laura; Júdez, Diego; Rabanaque, María José

    2009-04-01

    To analyse the opinions of physicians on the appropriateness of research into the relationships between doctors and pharmaceutical industry, and to evaluate the usefulness of email survey in this research. Survey via email of 373 authors of papers published in Spanish medical journals in 2007. The relationships between doctors and the industry was measured by asking doctors what they had received from industry during last year, the value in euro, and the number of visits from industry representatives. The response rate was 28.2%. Most physicians (90.5%) considered the study appropriate. Only 3.2% of doctors refused to take part in the study due to disagreeing with methodology. A total of 92.8% received something from industry during last year (62% cost associated with professional meetings, 60% material for continuing medical education). Mean value of gifts received was 900 euro (60-12,000 euro). By sex, women apparently received more drug samples, and men more payments for consulting or enrolling patients in trials. Doctors practicing in hospitals seemed to receive more gifts than primary care doctors, particularly trips or lunch. Number of visits of industry representatives (from 5 to 10 weekly) was associated with more gifts to doctors. The vast majority of doctors agree with the appropriateness of researching into the relationships between doctors and the pharmaceutical industry. Relationships between physicians and industry appear to be intensive, as seen in other studies. Response rate was low, but the simplicity and speed of the method are valuable advantages.

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

    ERIC Educational Resources Information Center

    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…

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

    ERIC Educational Resources Information Center

    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…

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

    PubMed

    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.

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

    PubMed Central

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

    2005-01-01

    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. PMID:15801942

  9. 76 FR 25696 - Guidance for Industry on Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-05

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Dosage Delivery Devices for Orally.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... intended to provide guidance to firms that are manufacturing, marketing, or distributing orally...

  10. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... guidance for industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are... HUD designation may be eligible for marketing approval under the Humanitarian Device Exemption...

  11. Oversight of marketing relationships between physicians and the drug and device industry: a comparative study.

    PubMed

    Jost, Timothy Stoltzfus

    2010-01-01

    Throughout the world, complex mutually-dependent relationships exist between physicians and pharmaceutical and medical device companies. This article focuses on one particular aspect of these relationships-payments made by drug and device companies to physicians and their organizations and institutions to market drugs and devices. It is widely believed that drug and device company marketing to physicians creates conflicts of interest that corrupt physician judgment and increase the cost of medical care. This article examines first the economic basis of physician/industry relationships that causes conflicts to arise. It next considers the measures that a number of developed countries have taken to respond to these relationships. Finally, it proposes an approach that would comprehensively address the problems caused by drug and device company marketing to physicians.

  12. Partnership between academia and industry for drug discovery in Alzheimer's disease.

    PubMed

    Ivinson, Adrian J; Lane, Roger; May, Patrick C; Hosford, David A; Carrillo, Maria C; Siemers, Eric R

    2008-03-01

    Drug discovery has traditionally been almost exclusively the purview of pharmaceutical and biotechnology companies, whereas universities have focused on basic research. However, given the challenges involved in discovering and developing truly effective, symptomatic treatments and disease-modifying drugs for Alzheimer's disease, there is a need to reassess this simple division of labor. Whereas each sector is likely to retain a core interest and expertise at either end of the drug discovery spectrum, there is room for closer cooperation at the intersection of the for-profit and not-for-profit sectors. The Alzheimer's Association Research Roundtable convened a meeting of senior industry researchers and academic investigators to discuss this intersection and to assess the opportunity for closer partnership on Alzheimer's disease drug discovery and development.

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

    PubMed

    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.

  14. Author financial conflicts of interest, industry funding, and clinical practice guidelines for anticancer drugs.

    PubMed

    Tibau, Ariadna; Bedard, Philippe L; Srikanthan, Amirrtha; Ethier, Josee-Lyne; Vera-Badillo, Francisco E; Templeton, Arnoud J; Ocaña, Alberto; Seruga, Bostjan; Barnadas, Agustí; Amir, Eitan

    2015-01-01

    Clinical practice guidelines (CPGs) and consensus statements (CSs) are used to apply evidence-based medicine or expert recommendations to clinical practice. Here we explore author financial conflicts of interest (FCOIs), sources of guideline funding, and their relationship with endorsement of specific drugs. An electronic search of MEDLINE was conducted to identify CPGs and CSs for common solid cancers published between January 2003 and October 2013. The search was restricted to articles evaluating systemic therapy. We extracted data on self-reported author FCOIs, funding sources, use of manuscript writers, and endorsement of specific drugs in the abstract of the article. Of 142 articles evaluated, 64% were CPGs, and 36% were CSs. The proportion of articles reporting FCOIs improved from 11% in 2003 to 93% in 2013 (P for trend < .001). Only 45% of articles explicitly reported funding sources. Of these, 65% disclosed partial or full industry sponsorship. Use of manuscript writers was declared in 13%, but many articles did not explicitly report the role of authors in the writing of the manuscript. Endorsement of specific drugs was significantly associated with author FCOIs (odds ratio [OR], 7.29; P = .001), but not with industry funding (OR, 0.95; P = .37). Reporting of FCOIs in CPGs and CSs has improved over time. Despite prevalent funding of guideline development by industry, such funding is not associated with endorsement of specific drugs. Author FCOIs are prevalent, and endorsement of a specific drug seems to be more common when authors have FCOIs with the pharmaceutical company marketing that drug. © 2014 by American Society of Clinical Oncology.

  15. Nanotechnology-based drug delivery systems for Alzheimer's disease management: Technical, industrial, and clinical challenges.

    PubMed

    Wen, Ming Ming; El-Salamouni, Noha S; El-Refaie, Wessam M; Hazzah, Heba A; Ali, Mai M; Tosi, Giovanni; Farid, Ragwa M; Blanco-Prieto, Maria J; Billa, Nashiru; Hanafy, Amira S

    2017-01-10

    Alzheimer's disease (AD) is a neurodegenerative disease with high prevalence in the rapidly growing elderly population in the developing world. The currently FDA approved drugs for the management of symptomatology of AD are marketed mainly as conventional oral medications. Due to their gastrointestinal side effects and lack of brain targeting, these drugs and dosage regiments hinder patient compliance and lead to treatment discontinuation. Nanotechnology-based drug delivery systems (NTDDS) administered by different routes can be considered as promising tools to improve patient compliance and achieve better therapeutic outcomes. Despite extensive research, literature screening revealed that clinical activities involving NTDDS application in research for AD are lagging compared to NTDDS for other diseases such as cancers. The industrial perspectives, processability, and cost/benefit ratio of using NTDDS for AD treatment are usually overlooked. Moreover, active and passive immunization against AD are by far the mostly studied alternative AD therapies because conventional oral drug therapy is not yielding satisfactorily results. NTDDS of approved drugs appear promising to transform this research from 'paper to clinic' and raise hope for AD sufferers and their caretakers. This review summarizes the recent studies conducted on NTDDS for AD treatment, with a primary focus on the industrial perspectives and processability. Additionally, it highlights the ongoing clinical trials for AD management.

  16. "We don't have no drugs education": The myth of universal drugs education in English secondary schools?

    PubMed

    Fletcher, Adam; Bonell, Chris; Sorhaindo, Annik

    2010-11-01

    Despite concerns regarding youth drug use and 'standards' of drugs education in British schools, little is known about young people's routine experiences of drugs education at school, or schools' other priorities, policies and practices relating to drugs. Qualitative data were collected through semi-structured interviews with students aged 14-15 (N=50) and teachers (N=10) at four schools in England. We used thematic content analysis to explore: young people's accounts of drugs education at secondary school and what they have learnt from this; and students' and teachers' accounts of schools' wider policies and practices relating to drugs. A recurring theme was that students reported having received little or no drugs education; the majority could not remember having had any at their secondary school. These students were not the 'drugwise' youth described in the normalisation thesis and young people wanted their school to provide them with more information. Teachers recognised that schools' drugs policies were rarely implemented in practice and that drugs education was not a priority. Schools also appear to be adopting new strategies based on surveillance and targeting to control students' drug use. In some cases referrals to a drugs counsellor were coercive and appeared to merely replace classroom-based drugs education. This study provides further evidence of the gap between drug policies and practice. It may be possible to increase the priority given to comprehensive drugs education and supportive drugs policies by modifying the incentive structures that schools work within. New targeted responses are unlikely to be effective at reducing drug-related harm at a population level because of the small number of students reached, and can be stigmatising. Further research is needed to explore schools' focus on surveillance and targeted control rather than universal education, and to examine interventions that might ensure schools implement adequate drugs education

  17. SPECIAL ENGLISH.

    ERIC Educational Resources Information Center

    English Language Services, Inc., Washington, DC.

    THIS 14-VOLUME SERIES OF TECHNICAL ENGLISH TEXTS IS DESIGNED TO PROVIDE PRACTICE IN TECHNICAL TERMINOLOGY FOR NON-NATIVE SPEAKERS OF ENGLISH. LANGUAGE FLUENCY LEVEL IS UPPER-INTERMEDIATE/ADVANCED. THE VARIOUS FIELDS OF INDUSTRY WHICH THE TEXTS DEAL WITH ARE AS FOLLOWS--(1) AGRICULTURE--BOOK 1, SOILS (2) AGRICULTURE--BOOK 2, FIELD CROPS (3)…

  18. SPECIAL ENGLISH.

    ERIC Educational Resources Information Center

    English Language Services, Inc., Washington, DC.

    THIS 14-VOLUME SERIES OF TECHNICAL ENGLISH TEXTS IS DESIGNED TO PROVIDE PRACTICE IN TECHNICAL TERMINOLOGY FOR NON-NATIVE SPEAKERS OF ENGLISH. LANGUAGE FLUENCY LEVEL IS UPPER-INTERMEDIATE/ADVANCED. THE VARIOUS FIELDS OF INDUSTRY WHICH THE TEXTS DEAL WITH ARE AS FOLLOWS--(1) AGRICULTURE--BOOK 1, SOILS (2) AGRICULTURE--BOOK 2, FIELD CROPS (3)…

  19. 78 FR 9396 - Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of... entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance... developing drugs for the treatment of early Alzheimer's disease. It does not create or confer any rights...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Influenza: Developing Drugs for... entitled ``Influenza: Developing Drugs for Treatment and/or Prophylaxis.'' This guidance is intended to... treatment and/or prophylaxis of illness caused by influenza viruses A and B, including both seasonal and...

  1. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... HUMAN SERVICES Food and Drug Administration (Formerly Docket No. 2006D-0344) Draft Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling... entitled ``Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and...

  2. 76 FR 50483 - Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  3. 76 FR 20688 - Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; 30- Day Notices, 135-Day Premarket Approval Supplements and 75-Day Humanitarian Device Exemption Supplements for Manufacturing Method or Process Changes; Availability AGENCY: Food and Drug Administration...

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

    PubMed

    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. Regulation of drugs and chemicals used by the poultry industry. Good manufacturing practices.

    PubMed

    Boyd, L H

    1994-09-01

    Good manufacturing practices (GMP) are required to be followed in the use of animal drugs to produce medicated feeds. The authority is found in the federal Food, Drug, and Cosmetic Act, which states that medicated feed can be deemed adulterated if GMP were not followed in its production. This authority has been translated into GMP regulations applicable to all medicated feed production. More detailed GMP are imposed on those using high potency sources of drugs that require a withdrawal period (Category II). Less detailed GMP are imposed on all other drug uses (Category I and lower potency sources of Category II). Facility registration, medicated feed applications, and biennial inspections are also imposed on those required to follow the more detailed GMP regulations. The basic thrust of the regulations is assurance that drug use is correct in all respects and that the integrity of all medicated and nonmedicated feeds is maintained. The objective is food free of illegal drug residues, i.e., food safety. The GMP regulations are based on joint industry-government endeavor and reflect the practical realities of feed manufacturing. They are, for all practical purposes, good business practices assuring that medicated feeds make a positive contribution to food production and consumer confidence.

  6. Drug delivery strategies for poorly water-soluble drugs: the industrial perspective.

    PubMed

    van Hoogevest, Peter; Liu, Xiangli; Fahr, Alfred

    2011-11-01

    For poorly soluble compounds, a good bioavailability is typically needed to assess the therapeutic index and the suitability of the compound for technical development. In industry, the selection of the delivery technology is not only driven by technical targets, but also by constraints, such as production costs, time required for development and the intellectual property situation. This review covers current developments in parenteral and oral delivery technologies and products for poorly water-soluble compounds, such as nano-suspensions, solid dispersions and liposomes. In addition, the use of biorelevant dissolution media to assess dissolution and solubility properties is described. Suggestions are also included to systematically address development hurdles typical of poorly water-soluble compounds intended for parenteral or oral administration. A holistic assessment is recommended to select the appropriate delivery technology by taking into account technical as well as intellectual property considerations. Therefore, first and foremost, a comprehensive physico-chemical characterization of poorly water-soluble compounds can provide the key for a successful selection and development outcome. In this context, the identified physical form of the compound in the formulation is used as a guide for a risk-benefit assessment of the selected oral delivery technology. The potential of nano-suspensions for intravenous administration is unclear. In the case of oral administration, nano-suspensions are mainly used to improve the oral absorption characteristics of micronized formulations. The development of an in situ instantaneous solubilization method, based on stable, standardized liposomes with low toxicity, opens new avenues to solubilize poorly water-soluble compounds.

  7. Illicit Drug and Injecting Equipment Markets inside English Prisons: A Qualitative Study

    ERIC Educational Resources Information Center

    Hughes, Rhidian

    2003-01-01

    In recent years, disrupting the supply of illicit drugs and injecting equipment inside Her Majesty's (HM) prisons has become an important focus for prison drug policy. This paper presents findings from qualitative research, which invited 24 drug injectors with prison experience to discuss the role and operation of illicit drug and injecting…

  8. The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy

    PubMed Central

    Löfgren, Hans

    2007-01-01

    This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products. PMID:17543115

  9. Subjective risk assessment and perception in the Greek and English bakery industries.

    PubMed

    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.

  10. Mold Control and Detection In Biological Drug Substance Manufacturing Facilities: An Industry Perspective.

    PubMed

    Bawa, Anita; Asefi, Sophia; Ramsey, Stephanie; Arbesser-Rastburg, Christine; Paul, Mousumi; Leira, Francisco; McFarland, Kim; Landeryou, Tracy; Reddy, Bindhu; Murphy, Marie; Daddis, Barbara; Baine, David; Willison-Parry, Derek

    2017-06-16

    The biopharmaceutical industry produces non-sterile and/or low-bioburden intermediates and bulk biologics (i.e. Drug Substances) using bioburden controlled processes in accordance to Q7A and Annex 2. In many cases, single mold isolation events have received a high level of scrutiny; the goal of this paper is to challenge this paradigm and provide the rationale for an enhanced control approach that focuses on trending of mold species as microbial indicators rather than on single isolation events. Molds, can also be part (in much lower numbers) of the normal microbial population of a biologics manufacturing facility and, therefore, mold isolation is not an unexpected event in non-aseptic processing environments. This presentation provides recommendations from a biopharmaceutical industry perspective on mold monitoring in biologics drug substance facilities and processes. Additionally, recommendations on subjects commonly encountered in the establishment of a monitoring program, such as mold trending, responding to mold isolation events and best practices on mold prevention, are included. These recommendations assist biologic manufacturers in refining their current mold control strategy, as well as developing control strategies for new processes, facilities and products. Establishing appropriate mold control programs is a key element of overall microbial control plans in biologics manufacturing facilities. Copyright © 2017, Parenteral Drug Association.

  11. Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation.

    PubMed

    Cosgrove, Lisa; Vannoy, Steven; Mintzes, Barbara; Shaughnessy, Allen F

    2016-01-01

    The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the "ghost management" of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased-rather than evidence-based-medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive "me-too" drugs with questionable risk/benefit profiles. We offer solutions for neutralizing these economies of influence.

  12. 77 FR 20825 - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ...; User Fees for 513(g) Requests for Information; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information.'' This guidance document describes the user fees associated with 513(g) requests...

  13. 77 FR 14811 - Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Direct-to-Consumer Television Advertisements--the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad Pre... entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review...

  14. 77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... establishment in 1995, the pre-IDE program has been a successful resource for both medical device applicants and... clinical studies conducted outside of the United States to support future U.S. marketing applications (Ref...

  15. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... System; the European Union Notified Body Accreditation System; the Therapeutics Goods Administration of... HUMAN SERVICES Food and Drug Administration Guidance for Industry, Third Parties and Food and Drug... manufacturer whose establishment has been audited under one of the regulatory systems implemented by the...

  16. Mixing drink and drugs: 'Underclass' politics, the recovery agenda and the partial convergence of English alcohol and drugs policy.

    PubMed

    Monaghan, Mark; Yeomans, Henry

    2016-11-01

    Alcohol policy and illicit drugs policy are typically presented as separate and different in academic discussion. This is understandable, to a degree, as the criminal law upholds a 'great regulatory divide' (Seddon, 2010: 56) separating the licit trade in alcohol from the illicit trade in substances classified as either class A, B or C under the Misuse of Drugs Act 1971. This paper takes a different stance. In doing so, it draws upon Berridge's (2013) argument that policies governing various psychoactive substances have been converging since the mid-twentieth century and seeks to elaborate it using recent developments relating to the control and regulation of drugs and alcohol in the broader areas of criminal justice and welfare reform. Significantly, the article examines how recent policy directions relating to both drugs and alcohol in England have, under the aegis of the 'recovery agenda', been connected to a broader behavioural politics oriented towards the actions and lifestyles of an apparently problematic subgroup of the population or 'underclass'. The paper thus concludes that, although the great regulatory divide remains intact, an underclass politics is contributing towards the greater alignment of illicit drugs and alcohol policies, especially in regards to the respective significance of abstinence (or abstinence-based 'recovery').

  17. Controversies in drug and industry--its measures: a view point.

    PubMed

    Narayana, A

    2003-01-01

    Man has been fascinated by nature since he evolved from his primitive ancestors, the apes. No doubt to start with, he hunted for food mainly by killing the wild animals, but if there was anything on which he could depend upon with any confidence towards its availability, it was the plant. Not only the fact that a large number of plants provided him with food but also the fact that they provided him with curative medicine and shelter, were perhaps the reasons why he worshiped them more than the animals which also gave him food. There are a large number of plants, which are used by the people all over India for curse against witchcraft or to remove the effect of the evil eye and sickness. The use of the flora in India to relieve mankind from their sufferings was known from the ancient days. This includes all food, fuel, shelter, drugs, cosmetics etc. The standards have been maintained for several centuries since the disciples were trained in the forest close to the natural flora. In the present paper certain useful methodologies are evaluated for preparing standard Herbal formulations and focus mainly on two things namely drug (Dravya) and industry (pharmaceutical industry).

  18. Psychotropic drug use in a cohort of workers 4 years after an industrial disaster in France.

    PubMed

    Diène, Eloi; Geoffroy-Perez, Béatrice; Cohidon, Christine; Gauvin, Stéphanie; Carton, Matthieu; Fouquet, Aurélie; Fatras, Jean-Yves; Imbernon, Ellen

    2014-08-01

    Two years after the 2001 Toulouse industrial disaster, a longitudinal study was set up to evaluate the impact of the disaster. The current substudy examines the medium-term impact (5 years) the incident had on the mental health of 3,004 participants. As part of the monitoring, data relating to the psychotropic drug use of 2,494 participants were collected from administrative databases 4 years after the disaster. Use of psychotropics was higher among women for anxiolytics (10.4% for men and 15.0% for women), hypnotics (10.5% and 17.0%), and antidepressants (7.6% and 11.2%). Exposure to the disaster, especially proximity to the exposure, was significantly associated with the use of antidepressants in men, OR = 3.22, 95% CI[1.57, 6.61]. This was also the case for other exposure factors (saw dead or injury, injured, home damage, death or injury loved one, psychological disorders, exposure toxic fumes): range of OR 1.75 to 2.52 in men, 1.48 to 1.62 in women. In conclusion, this study highlights the medium-term psychological impact of an industrial disaster on psychotropic drug use and the potential for using medical records data as a means for tracking postdisaster mental health. Copyright © 2014 International Society for Traumatic Stress Studies.

  19. English Teaching Profile: New Zealand.

    ERIC Educational Resources Information Center

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

    A profile of the state of English and English instruction in New Zealand covers the following topics: a description of the role and status of English language use in industry and commerce, government, and education; the role of English at all levels of the educational system; the availability and training of teachers of English, the type of…

  20. The changing environment of graduate and postdoctoral training in drug metabolism: viewpoints from academia, industry, and government.

    PubMed

    Stevens, Jeffrey C; Dean, Dennis C; Preusch, Peter C; Correia, Maria Almira

    2003-04-01

    This article is an invited report of a symposium sponsored by the Drug Metabolism Division of the American Society for Pharmacology and Experimental Therapeutics held at Experimental Biology 2002 in New Orleans. The impetus for the symposium was a perceived shortage in the supply of graduate students qualified for drug metabolism research positions in industry, academia, and government. For industry, recent hiring stems largely from the expansion of drug metabolism departments in an effort to keep pace with the demands of drug discovery and new technologies. In turn, regulatory scientists are needed to review and verify the results of the increased number and volume of studies required for drug development and approval. Thus the initial source of training, academia, has been forced to recognize these external hiring pressures while trying to attract and retain the faculty, postdoctoral scientists, and students necessary for active teaching and research programs. The trend of the expansion of the interdisciplinary nature of traditional drug metabolism to include emerging technologies such as pharmacogenetics, transporters, and proteomics and the implications for future needs in training and funding were acknowledged. There was also consensus on the value of partnerships between academia and industry for increasing student interest and providing training in disciplines directly applicable to industrial drug metabolism research. Factors affecting the sources of these trainees, such as federal funding, the number of trainees per institution, and recent issues with immigration restrictions that have limited the flow of scientists were also discussed.

  1. Project VOICE (Vocational Occupations for Industrial Communications English): A Competency Based Education Curriculum for the Limited English Proficient in Building Maintenance.

    ERIC Educational Resources Information Center

    Chaloupka, Diana; Papierniak, Kathleen, Ed.

    Developed for vocational educators of short-term or long-term programs, this manual presents a complete competency-based curriculum in building maintenance for the advanced limited English proficient student. Following instructions on use of the manual and recommended references, a student tracking system and record sheet are provided, which list…

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

    PubMed

    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.

  3. Productive university, industry, and government relationships in preclinical drug discovery and development: considerations toward a synergistic lingua franca.

    PubMed

    Janero, David R

    2012-06-01

    Efficiency and productivity shortfalls conspire with subpar economic return to stigmatize the pharmaceutical industry and jeopardize its viability. This complex and costly innovation-to-commercialization failure, the formidable associated costs, and the relevance of various core competencies endemic to universities, the pharmaceutical industry, and government have been major drivers for establishing preclinical drug-discovery alliances involving these constituencies. Such cross-sector alliances have the potential to help restore at least some of the industry's former health by militating risk, enhancing productivity, and improving the quantity/quality of development candidates. This Editorial will highlight certain characteristics of pharma-industry and non-industrial settings that can jeopardize the effectiveness of these sectors for unified preclinical discovery campaigns capable of generating well-characterized drug candidates that merit human testing. Based on decades of research and development (R&D) and business experience spanning international big-pharma, biotechnology, and academic spheres, the author opines that a synergistic lingua franca is required among involved constituencies in order for such cross-sector discovery alliances to emerge as robust drug-discovery engines fueled by joint intellectual effort. Technology-transfer professionals, postdoctoral trainees, and consultants are discussed as resources for helping establish the university-industry-government triumvirate as a normative innovation network for preclinical drug discovery and development in the 21st century.

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

    ERIC Educational Resources Information Center

    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…

  5. Advanced English as a Second Language for Manufacturing. P.R.I.D.E. People Retraining for Industry Excellence.

    ERIC Educational Resources Information Center

    Lewandowski, Carol

    This workplace skills training course in English as a Second Language (ESL) identifies English problems for nonnative speakers and encourages students to practice speaking, writing, listening, and reading skills using company literature. Introductory material includes course description, objectives, topical outline, and evaluation. The course…

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

    ERIC Educational Resources Information Center

    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…

  7. English as a Second Language in the Workplace. P.R.I.D.E. People Retraining for Industry Excellence.

    ERIC Educational Resources Information Center

    Lewandowski, Carol

    This workplace skills course in English as a Second Language in the workplace identifies English problems for non-native speakers and encourages students to practice speaking, writing, listening, and reading skills using company literature such as procedures, lists, policies, and safety information. Introductory material includes pre- and…

  8. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS... Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act.'' This... Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act'' to the Division...

  9. The Impact of Chemical Probes in Drug Discovery: A Pharmaceutical Industry Perspective.

    PubMed

    Garbaccio, Robert M; Parmee, Emma R

    2016-01-21

    Chemical probes represent an important component of both academic and pharmaceutical drug discovery research. As a complement to prior reviews that have defined this scientific field, we aim to provide an industry perspective on the value of having high-quality chemical probes throughout the course of preclinical research. By studying examples from the internal Merck pipeline, we recognize that these probes require significant collaborative investment to realize their potential impact in clarifying the tractability and translation of a given therapeutic target. This perspective concludes with recommendations for chemical probe discovery aimed toward maximizing their potential to identify targets that result in the successful delivery of novel therapeutics. Copyright © 2016 Elsevier Ltd. All rights reserved.

  10. An industry perspective on the role and utility of animal models of pain in drug discovery.

    PubMed

    Whiteside, Garth T; Pomonis, James D; Kennedy, Jeffrey D

    2013-12-17

    In recent years, animal behavioral models, particularly those used in pain research, have been increasingly scrutinized and criticized for their role in the poor translation of novel pharmacotherapies for chronic pain. This article addresses the use of animal models of pain from the perspective of industrial drug discovery research. It highlights how, when, and why animal models of pain are used as one of the many experimental tools used to gain better understanding of target mechanisms and rank-order compounds in the iterative process of establishing structure-activity relationships (SAR). Together, these models help create an 'analgesic signature' for a compound and inform the indications most likely to yield success in clinical trials. In addition, the authors discuss some often under-appreciated aspects of currently used (traditional) animal models of pain, including how industry balances efficacy with side effect measures as part of the overall conclusion of efficacy. This is provided to add perspective regarding current efforts to develop new models and endpoints both in rodents and larger animal species as well as assess cognitive and/or affective aspects of pain. Finally, the authors suggest ways in which efficacy evaluation in animal models of pain, whether traditional or new, might better align with clinical standards of analysis, citing examples where applying effect size and NNT estimations to animal model data suggest that the efficacy bar often may be set too low preclinically to allow successful translation to the clinical setting. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  11. Association of Industry Funding with the Outcome and Quality of Randomized Controlled Trials of Drug Therapy for Rheumatoid Arthritis

    PubMed Central

    Khan, Nasim A.; Lombeida, Juan I.; Singh, Manisha; Spencer, Horace J.; Torralba, Karina D.

    2013-01-01

    Objective To assess the association of industry funding with the characteristics, outcome, and reported quality of randomized controlled trials (RCTs) of drug therapy for rheumatoid arthritis (RA). Methods MEDLINE and Cochrane Central Register of Controlled Trials databases were searched to identify original RA drug therapy RCTs published in 2002–3 & 2006–7. Two reviewers independently assessed each RCT for the funding source, characteristics, outcome [positive (statistically significant result favoring experimental drug for the primary outcome) or not positive], and reporting of methodological measures whose inadequate performance may bias treatment effect assessment. RCTs registered at ClinicalTrials.gov and completed in the study years were assessed for publication bias. Results 103 eligible RCTs were identified with following funding sources: 58 (56.3%) industry; 19 (18.4%) non-profit; 6 (5.8%) mixed; and 20 (19.4%) unspecified. Industry funded RCTs had significantly more study centers and subjects; while non-profit funded RCTs had longer duration, and were more likely to study different treatment strategies. Outcome could be assessed for 86 (83.5%) RCTs. Funding source was not associated with higher likelihood of positive outcomes favoring the sponsored experimental drug [industry (75.5%), non-profit (68.8%), mixed (40%), and unspecified (81.2%); p = 0.37]. Industry funded RCTs had trend towards higher likelihood of non-publication (38.6% versus 16.7%, p = 0.093). Industry-funded RCTs reported more frequent performance of double-blinding, adequate participant flow description, and intention-to-treat analysis. Conclusion Industry funding was not associated with higher likelihood of positive outcomes of published drug therapy RCTs for RA, and reported better on some key RCT quality measures. PMID:22275179

  12. 78 FR 75570 - Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-12

    ... Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing... or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily... Medicated Feed or Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors for...

  13. Industry

    SciTech Connect

    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

  14. Association of industry funding with the outcome and quality of randomized controlled trials of drug therapy for rheumatoid arthritis.

    PubMed

    Khan, Nasim A; Lombeida, Juan I; Singh, Manisha; Spencer, Horace J; Torralba, Karina D

    2012-07-01

    To assess the association of industry funding with the characteristics, outcome, and reported quality of randomized controlled trials (RCTs) of drug therapy for rheumatoid arthritis (RA). The Medline and Cochrane Central Register of Controlled Trials databases were searched to identify original RA drug therapy RCTs published in 2002-2003 and 2006-2007. Two reviewers independently assessed each RCT for the funding source, characteristics, outcome (positive [statistically significant result favoring experimental drug for the primary outcome] or not positive), and reporting of methodologic measures whose inadequate performance may have biased the assessment of treatment effect. RCTs that were registered at ClinicalTrials.gov and completed during the study years were assessed for publication bias. Of the 103 eligible RCTs identified, 58 (56.3%) were funded by industry, 19 (18.4%) were funded by nonprofit sources, 6 (5.8%) had mixed funding, and funding for 20 (19.4%) was not specified. Industry-funded RCTs had significantly more study centers and subjects, while nonprofit agency-funded RCTs had longer duration and were more likely to study different treatment strategies. Outcome could be assessed for 86 (83.5%) of the 103 RCTs studied. The funding source was not associated with a higher likelihood of positive outcomes favoring the sponsored experimental drug (75.5% of industry-funded RCTs had a positive outcome, compared with 68.8% of non-industry-funded RCTs, 40% of RCTs with mixed funding, and 81.2% of RCTs for which funding was not specified). Industry-funded RCTs showed a trend toward a higher likelihood of nonpublication (P=0.093). Industry-funded RCTs were more frequently associated with double-blinding, an adequate description of participant flow, and performance of an intent-to-treat analysis. Industry funding was not associated with a higher likelihood of positive outcomes of published RCTs of drug therapy for RA, and industry-funded RCTs performed

  15. 75 FR 32953 - Guidance for Industry and Food and Drug Administration Staff; Use of “Light,” “Mild,” “Low,” or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Use...

  16. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

    PubMed

    Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

    2015-06-01

    Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.

  17. 77 FR 20025 - Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., 10903 New Hampshire Ave., Bldg. 51, Rm. 4288, Silver Spring, MD 20993-0002, 301- 796-0584; Paul Loebach, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg....

  18. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic... of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act...

  19. 76 FR 60504 - Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ... designed to clarify the TEA process and what happens after a TEA is submitted. This guidance finalizes the... of 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...

  20. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... Staff; User Fees for 513(g); Requests for Information; Availability AGENCY: Food and Drug Administration... the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.'' This draft guidance describes the user fees associated with 513(g) requests for...

  1. Is there an industrial future for phytopharmaceutical drugs? An outline of UNIDO programmes in the sector.

    PubMed

    Wijesekera, R O

    1991-04-01

    Although a substantial proportion of the health-care expenditure of developing countries is spent on the acquisition of drugs, this is only sufficient to serve about a quarter of their population. Therefore it is inconceivable that WHO's goal of HEALTH FOR ALL by the year 2000 could even be approached without consideration being given to the role in health care systems of herbal medicines. In this endeavour, traditional herbal medicines must perforce be granted the benefits of modern science and technology to serve future global needs. Here we are addressing both a contigency situation as well as a long term one. In developing nations there is a dire need for an improved supply of therapeutic agents for a variety of diseases that are characteristic of deprivation and poverty. In addition herbal medicines promise to provide both concepts of therapy, as well as therapeutic agents in areas where modern medicine has few answers. UNIDO's programmes for technical assistance to developing nations aim at the fullest utilisation of traditional herbal-based pharmacopoeias in addressing both these situations. They have employed a multi-disciplinary approach to the industrial production of herbal medicines. The projects endeavour to utilise the natural flora, judiciously, for selection, domestication and crop-wise cultivation of medicinal plant species for industrial processing. National R & D efforts have been strengthened to include the development of expertise in several areas such as instrumental analyses, biological assessment of raw materials as well as products. Process technology development has received special attention. A versatile poly-functional pilot plant has been developed to enable the production of herbal preparations as well as extracts and phytochemicals.(ABSTRACT TRUNCATED AT 250 WORDS)

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

    PubMed

    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.

  3. 77 FR 61417 - Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-09

    ...: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Acute Bacterial Sinusitis: Developing Drugs for Treatment.'' This guidance addresses FDA's... an indication for the treatment of acute bacterial sinusitis (ABS). This guidance finalizes...

  4. Good research practices for measuring drug costs in cost effectiveness analyses: an industry perspective: the ISPOR Drug Cost Task Force report--Part V.

    PubMed

    Mycka, Jack M; Dellamano, Renato; Kolassa, Eugene Mick; Wonder, Michael; Ghosh, Sabyasachi; Hay, Joel W; Smeeding, Jim

    2010-01-01

    The industry perspective on drug costs should be framed by the need for decision-makers to use actual and relevant costs, and to inform real-world decisions regarding medication selection and use. The objective of this report is to provide guidance and recommendations on how manufacturers should approach the use of drug costs. The Task Force was appointed with the advice and consent of the ISPOR Board of Directors. Members were experienced developers or users of drug cost information working in academia and industry, and came from several countries. Following the core assumptions developed and outlined by the Task Force, a draft report was prepared. Comments were solicited on the outline and several draft reports both from a core group of external reviewers and more broadly from the ISPOR membership of ISPOR via the ISPOR Web site. The industry should always strive for: 1) a focus on drug value and not just cost; 2) credibility-that is correct and consistent costs; 3) transparency-by disclosing the prices and costs, and ensuring that they reflect the actual cost of the drug whenever possible; and 4) providing actionable results that help customers comprehend the value offered by a drug therapy and to use products more efficiently and effectively. Understanding and accounting for all costs and consequences of the use of a medical treatment is in the best interests of all parties involved in the prescribing, consuming, reimbursement, selling, and manufacturing of bio/pharmaceuticals. Transparency, consistency, and clear communication of costs and value are essential for appropriate decision-making and should be important goals for all parties.

  5. Providers' payment and delivery system reforms hold both threats and opportunities for the drug and device industries.

    PubMed

    Robinson, James C

    2012-09-01

    For decades, medical device and specialty drug makers have produced a steady stream of breakthroughs and incremental improvements, from cancer therapies to orthopedic joint replacements, drug-eluting stents, and cardiac pacemakers. The advances were financed by a fragmented health care system that paid for whichever clinical technologies were favored by physicians without strong concern for cost. But now hospitals, health systems, insurers, and policy makers are embracing payment reforms that seek to control costs and foster uniformity in the adoption of new drugs and devices. This article explores payment reforms that will have an impact on the medical technology industry and describes opportunities for the industry to flourish in this new, more financially constrained landscape.

  6. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing... Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning... in or on medicated feed or in drinking water of food-producing animals. The purpose of this draft...

  7. Evaluation of a New Molecular Entity as a Victim of Metabolic Drug-Drug Interactions-an Industry Perspective.

    PubMed

    Bohnert, Tonika; Patel, Aarti; Templeton, Ian; Chen, Yuan; Lu, Chuang; Lai, George; Leung, Louis; Tse, Susanna; Einolf, Heidi J; Wang, Ying-Hong; Sinz, Michael; Stearns, Ralph; Walsky, Robert; Geng, Wanping; Sudsakorn, Sirimas; Moore, David; He, Ling; Wahlstrom, Jan; Keirns, Jim; Narayanan, Rangaraj; Lang, Dieter; Yang, Xiaoqing

    2016-08-01

    Under the guidance of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), scientists from 20 pharmaceutical companies formed a Victim Drug-Drug Interactions Working Group. This working group has conducted a review of the literature and the practices of each company on the approaches to clearance pathway identification (fCL), estimation of fractional contribution of metabolizing enzyme toward metabolism (fm), along with modeling and simulation-aided strategy in predicting the victim drug-drug interaction (DDI) liability due to modulation of drug metabolizing enzymes. Presented in this perspective are the recommendations from this working group on: 1) strategic and experimental approaches to identify fCL and fm, 2) whether those assessments may be quantitative for certain enzymes (e.g., cytochrome P450, P450, and limited uridine diphosphoglucuronosyltransferase, UGT enzymes) or qualitative (for most of other drug metabolism enzymes), and the impact due to the lack of quantitative information on the latter. Multiple decision trees are presented with stepwise approaches to identify specific enzymes that are involved in the metabolism of a given drug and to aid the prediction and risk assessment of drug as a victim in DDI. Modeling and simulation approaches are also discussed to better predict DDI risk in humans. Variability and parameter sensitivity analysis were emphasized when applying modeling and simulation to capture the differences within the population used and to characterize the parameters that have the most influence on the prediction outcome.

  8. Animals on drugs: understanding the role of pharmaceutical companies in the animal-industrial complex.

    PubMed

    Twine, Richard

    2013-12-01

    In this paper I revisit previous critiques that I have made of much, though by no means all, bioethical discourse. These pertain to faithfulness to dualistic ontology, a taken-for-granted normative anthropocentrism, and the exclusion of a consideration of how political economy shapes the conditions for bioethical discourse (Twine Medicine, Health Care and Philosophy 8(3):285-295, 2005; International Journal of Sociology of Agriculture and Food 16(3):1-18, 2007, 2010). Part of my argument around bioethical dualist ontology is to critique the assumption of a division between the "medical" (human) and "agricultural" (nonhuman) and to show various ways in which they are interrelated. I deepen this analysis with a focus on transnational pharmaceutical companies, with specific attention to their role in enhancing agricultural production through animal drug administration. I employ the topical case of antibiotics in order to speak to current debates in not only the interdisciplinary field of bioethics but also that of animal studies. More generally, the animal-industrial complex (Twine Journal for Critical Animal Studies 10(1):12-39, 2012) is underlined as a highly relevant bioethical object that deserves more conceptual and empirical attention.

  9. [Approval of drugs by national and European agencies--sequelae for the pharmaceutical industry].

    PubMed

    Zierenberg, O

    1997-11-01

    The research-based pharmaceutical industry supports the European harmonization process for the granting of pharmaceutical registrations. In order to improve consumer protection and the therapeutic options available to physicians in comparison to nationally registered products, the harmonization must be carried out on schedule and transparently a high scientific standard. It must not lead to the adoption of all national restrictions regarding data sheets and patient leaflets. Pharmaceutical products with the same ingredients can be registered either through the national or through the European procedure. This situation can only be remedied by the harmonization of core SPCs. This process must be agreed in consultation between pharmaceutical companies and regulatory authorities. With regard to measures to avert drug risks, professional associations and the pharmaceutical companies affected should be heard by the national authorities and their arguments given due consideration. In addition, national authorities and the CPMP must coordinate their decisions before they are published. In particular, the basis of these decisions should be made clear and therapeutic alternatives should be known.

  10. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is... information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not...

  11. The association between tobacco, alcohol, and drug use, stress, and depression among uninsured free clinic patients: U.S.-born English speakers, non-U.S.-born English speakers, and Spanish speakers.

    PubMed

    Kamimura, Akiko; Ashby, Jeanie; Tabler, Jennifer; Nourian, Maziar M; Trinh, Ha Ngoc; Chen, Jason; Reel, Justine J

    2017-01-01

    The abuse of substances is a significant public health issue. Perceived stress and depression have been found to be related to the abuse of substances. The purpose of this study is to examine the prevalence of substance use (i.e., alcohol problems, smoking, and drug use) and the association between substance use, perceived stress, and depression among free clinic patients. Patients completed a self-administered survey in 2015 (N = 504). The overall prevalence of substance use among free clinic patients was not high compared to the U.S. general population. U.S.-born English speakers reported a higher prevalence rate of tobacco smoking and drug use than did non-U.S.-born English speakers and Spanish speakers. Alcohol problems and smoking were significantly related to higher levels of perceived stress and depression. Substance use prevention and education should be included in general health education programs. U.S.-born English speakers would need additional attention. Mental health intervention would be essential to prevention and intervention.

  12. [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].

    PubMed

    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

  13. Drug Industry Groups Oppose FDA "Quality Metrics" Plan: The Agency Wants to Use Manufacturing Data to Attack Drug Shortages.

    PubMed

    Barlas, Stephen

    2017-07-01

    Raising their voices in nearly unanimous opposition, pharmaceutical manufacturers and their suppliers have mounted a campaign to dissuade the FDA from launching a voluntary program in 2018 that is aimed at reducing drug shortages.

  14. Reshaping the carcinogenic risk assessment of medicines: international harmonisation for drug safety, industry/regulator efficiency or both?

    PubMed

    Abraham, John; Reed, Tim

    2003-07-01

    The most significant institutional entity involved in the harmonisation of drug testing standards worldwide is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which comprises the three pharmaceutical industry associations and regulatory agencies of the EU, US and Japan. It is often claimed that such harmonisation will both accelerate the development and approval of new drugs and preserve safety standards, if not strengthen safety regimes. Drawing on extensive documentary research and interviews, this paper systematically examines whether the efforts by the ICH to improve industrial and regulatory efficiency by harmonising drug testing requirements is likely to raise, maintain or compromise safety standards in carcinogenic risk assessment of pharmaceuticals. The evidence suggests that, in the field of carcinogenicity testing, the ICH management of international harmonisation of medicines regulation is not achieving simultaneous improvements in safety standards and acceleration of drug development. Rather, the latter is being achieved at the expense of the former. Indeed, the ICH may be converting permissive regulatory practices of the past into new scientific standards for the future. These findings are significant as many expert scientific advisers to drug regulatory agencies seem to have accepted uncritically the conclusions reached by the ICH, which may affect a potential patient population of half a billion and tens of thousands of clinical trials.

  15. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... classification decisions and do not constitute FDA clearance or approval for marketing. Classification decisions and clearance or approval for marketing require submissions under different sections of the act... techniques, when appropriate, and other forms of information technology. Title: Draft Guidance for Industry...

  16. 75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-27

    ..., rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office... the safety and efficacy of a drug to be used under medical supervision. If a drug has abuse...

  17. How the pill became a lifestyle drug: the pharmaceutical industry and birth control in the United States since 1960.

    PubMed

    Watkins, Elizabeth Siegel

    2012-08-01

    Marketing decisions, rather than scientific innovations, have guided the development and positioning of contraceptive products in recent years. I review the stalled progress in contraceptive development in the decades following the advent of the Pill in 1960 and then examine the fine-tuning of the market for oral contraceptives in the 1990s and 2000s. Although birth control has been pitched in the United States as an individual solution, rather than a public health strategy, the purpose of oral contraceptives was understood by manufacturers, physicians, and consumers to be the prevention of pregnancy, a basic health care need for women. Since 1990, the content of that message has changed, reflecting a shift in the drug industry's view of the contraception business. Two factors contributed to bring about this change: first, the industry's move away from research and development in birth control and second, the growth of the class of medications known as lifestyle drugs.

  18. How the Pill Became a Lifestyle Drug: The Pharmaceutical Industry and Birth Control in the United States Since 1960

    PubMed Central

    Watkins, Elizabeth Siegel

    2012-01-01

    Marketing decisions, rather than scientific innovations, have guided the development and positioning of contraceptive products in recent years. I review the stalled progress in contraceptive development in the decades following the advent of the Pill in 1960 and then examine the fine-tuning of the market for oral contraceptives in the 1990s and 2000s. Although birth control has been pitched in the United States as an individual solution, rather than a public health strategy, the purpose of oral contraceptives was understood by manufacturers, physicians, and consumers to be the prevention of pregnancy, a basic health care need for women. Since 1990, the content of that message has changed, reflecting a shift in the drug industry's view of the contraception business. Two factors contributed to bring about this change: first, the industry's move away from research and development in birth control and second, the growth of the class of medications known as lifestyle drugs. PMID:22698049

  19. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and... Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act.'' This draft guidance provides updated... Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act.'' The...

  20. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act..., and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). The draft guidance...

  1. 75 FR 73109 - Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... Noninferiority Trials to Support Approval; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval.'' The purpose of... noninferiority (NI) clinical trial designs to evaluate antibacterial drug products. The Agency's thinking in this...

  2. Differences in the drug-metabolizing enzyme activities among fish and bivalves living in waters near industrial and non-industrial areas

    SciTech Connect

    Oshima, Y.; Kobayashi, K.; Hidaka, C.; Izu, S.; Imada, N. )

    1994-07-01

    Fish and shellfishes, living in coastal areas receiving agricultural, industrial and domestic wastewaters, have been exposed to various chemicals. Identifing the various harmful chemicals in the environments and accumulated in aquatic organisms is difficult. Even if concentrations of pollutants are low so that no mortality of fish and shellfishes occurs, the pollutants may affect the biochemistry and physiology of aquatic organisms. Activities of some drug-metabolizing enzymes, especially the cytochrome P-450 dependent monooxygenase (MO) in fish livers, increase when fish are exposed to environmental pollutants such as polycyclic aromatic hydrocarbons, halogenated organic chemicals. However, most studies have been done on the field evaluation only by MO induction in fish as a monitor for marine pollution with crude-oil and halogenated organic compounds, without regard for other chemicals. In a previous paper, the activity of benzo(a)pyrene hydroxylase (AHH) was induced by 22 times at 2-wk, although the cytochrome P-450 content increased only twice. Activity of phenol-sulfate transferase in the mid-gut gland of short-necked clam was induced by exposure to some phenolic compounds, especially pentachlorophenol (PCP), resulting in the increase of the enzyme activity by approximately 7 times the control after 5 wk exposure. Induced activity was maintained at least for 3 wk, even after the clam had been transferred to running clean sea water, although PCP accumulated in its body is rapidly excreted. Although the activity of this enzyme in the clam is easily induced by exposure to phenols, the induction of this enzyme activity in fish is very low as compared with that of clam. This paper examines the activities of drug-metabolizing enzymes of fish and bivalves living in waters near industrial and non-industrial areas to elucidate the applicability of the sulfate transferase activity in bivalves as a monitor for marine pollution, as well as the MO activity in fish.

  3. Improving the translation in Europe of nanomedicines (a.k.a. drug delivery) from academia to industry.

    PubMed

    Eaton, Michael A W

    2012-12-28

    Over the last decade the involvement of European academic scientists in the translation of Nanomedicines and Drug Delivery into useful therapeutics has been modest. Funders have become increasingly concerned and some attempts have been made in Europe to improve impact. While the consequences are minimal at present for stakeholders, the eventual impact at national and political levels could be serious and is likely to lead to reverse innovation - the import of healthcare products from developing economies - if not addressed. Some knowledge of industrial drug development is critical for innovation in this regulated sector - this information being not easily obtained outside Pharma. While peer review has failings, more important is project inception, since once started research takes on a life of its own. This paper aims to encourage healthcare researchers to take a more translational approach to selecting (applied) drug delivery projects.

  4. 76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-06

    ... proportions in the United States and more recently, worldwide. The morbidity and mortality associated with..., and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug...

  5. Peering into the Pharmaceutical “Pipeline”: Investigational Drugs, Clinical Trials, and Industry Priorities

    PubMed Central

    Cottingham, Marci D.; Kalbaugh, Corey A.

    2014-01-01

    In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry’s investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding – and often problematic – role of pharmaceuticals in society. To access the pharmaceutical industry’s pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2,477 different drugs in 4,182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline were being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered. PMID:25159693

  6. 78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-07

    ...: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological... ``Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological... for sponsors to consider in developing information to support a marketing application for a pen, jet...

  7. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-25

    ... qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple drug... Evaluation and Research (CDER) and DDT sponsors to support work towards qualification of an identified DDT and creates a mechanism for formal review of data by CDER to qualify the DDT and ensure that...

  8. Urinalysis and hair analysis for illicit drugs of driver applicants and drivers in the trucking industry.

    PubMed

    Mieczkowski, Tom

    2010-07-01

    The purpose of this article is to compare the differential rate of detection of illicit drugs when using two distinct sample types, hair and urine specimens. The specimens were collected from persons who applied for employment as a truck driver, or were collected from randomly selected currently employed truck drivers. The data is examined for job applicants and employees to determine if any differences in outcomes are associated with employment status or specimen type. The data is also assessed for specific patterns associated with particular drugs and their assay outcomes. Overall, it was determined that drug positive cases are relatively rare. Job applicants are more likely to test positive for an illicit drug than a currently employed driver. Applicants are more frequently positive for a drug by a factor of 3 for both urinalysis and hair analysis when compared to currently employed drivers. Approximately 2% of applicants were urine positive and 9% hair positive for an illegal drug. Considering employed truck drivers 0.6% were drug positive by urinalysis and 3% when using hair analysis. It is concluded that hair assays detect more drug use than urinalysis. It is also concluded that when urine and hair assay outcomes are non-concordant the typical case is a positive hair analysis with a negative urinalysis.

  9. 75 FR 63189 - Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ... Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug... ``Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies Can Be Conducted Without... requirements. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure...

  10. 78 FR 27116 - Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... considers your comment on this draft guidance before it begins work on the final version of the guidance..., to set forth criteria for charging for an investigational drug for the three types of expanded access.... Consistent with the goal of clarifying the requirements for charging for an investigational drug and the...

  11. Effective partnering of academic and physician scientists with the pharmaceutical drug development industry.

    PubMed

    Kennedy, Scott P; Bormann, B J

    2006-12-01

    This manuscript briefly addresses the drug discovery and development process. It is a long road from the formulation of a good discovery idea to the acceptance of a new drug in the marketplace, and there are many challenges faced along the way to the patient. Collaborations and partnerships are an important part of this process. There are a variety of partnering opportunities, ranging from the discovery of novel technologies and drug targets to lead discovery, compound gifts, and external sourcing. These partnerships help increase confidence and improve decision making on issues of safety and efficacy preclinically, which can reduce attrition and expedite the provision of new quality drugs to patients more quickly and at lower costs. Collaborations involve addressing multiple issues that include infrastructure, safety, regulatory matters, intellectual property, technical and personnel considerations, source document capture and data analysis issues, and legal and strategic alliances. A number of success factors are identified as important for quality collaborations in the drug development process.

  12. English for the Engineer.

    ERIC Educational Resources Information Center

    Daugherty, Wilson

    1964-01-01

    A brief description of the English program for students of engineering, architecture, and industrial management at Lawrence Institute of Technology includes fairly detailed information on the unique features of the 3-term freshman English course. Less extensive reference to the details of the sophomore, junior, and senior courses precedes a short…

  13. 78 FR 42965 - Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-18

    ... Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridium... Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard... Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection...

  14. 77 FR 59928 - Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

    ... previously conducted clinical trials with various effective antibiotics. The draft guidance also provides a... resistance to most antibacterial drugs on in vitro susceptibility testing. ] This draft guidance is being...

  15. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood..., Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic... Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications...

  16. 76 FR 80947 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ... Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Extension of Comment Period AGENCY: Food and Drug Administration... approaches FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk...

  17. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... mitigation strategies, under the IDE requirements. Early feasibility studies allow for limited early clinical... Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  18. Exploiting new approaches for natural product drug discovery in the biotechnology industry.

    PubMed

    Gullo, Vincent P; Hughes, Dallas E

    2005-01-01

    In recent years, large pharmaceutical companies have significantly reduced or eliminated the search for new therapeutic agents from natural sources. In spite of the many successes from natural product drug discovery, these companies have chosen to focus on compound libraries as the source of new lead compounds. Smaller biotechnology companies are continuing the search for novel natural products by developing and employing new and innovative approaches. This paper will describe some of these recent approaches to natural product drug discovery.:

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

    PubMed

    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.

  20. The Drug Discovery and Development Industry in India—Two Decades of Proprietary Small‐Molecule R&D

    PubMed Central

    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 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. PMID:28464443

  1. Rapid diagnostics of tuberculosis and drug resistance in the industrialized world: clinical and public health benefits and barriers to implementation

    PubMed Central

    2013-01-01

    In this article, we give an overview of new technologies for the diagnosis of tuberculosis (TB) and drug resistance, consider their advantages over existing methodologies, broad issues of cost, cost-effectiveness and programmatic implementation, and their clinical as well as public health impact, focusing on the industrialized world. Molecular nucleic-acid amplification diagnostic systems have high specificity for TB diagnosis (and rifampicin resistance) but sensitivity for TB detection is more variable. Nevertheless, it is possible to diagnose TB and rifampicin resistance within a day and commercial automated systems make this possible with minimal training. Although studies are limited, these systems appear to be cost-effective. Most of these tools are of value clinically and for public health use. For example, whole genome sequencing of Mycobacterium tuberculosis offers a powerful new approach to the identification of drug resistance and to map transmission at a community and population level. PMID:23987891

  2. Overview of the animal health drug development and registration process: an industry perspective.

    PubMed

    Hunter, Robert P; Shryock, Thomas R; Cox, Brian R; Butler, Roger M; Hammelman, Jason E

    2011-05-01

    Products for animal health commercialization follow a structured progression from initial concept through to regulatory approval. Typically, products are developed for use in either food animals or companion animals. These can be for the intention of disease intervention, productivity enhancement or improvement in a quality of life capacity. The animal health industry is a regulated industry, meaning that a government agency is responsible for oversight of products, both pre- and post-approval. There are three primary US government agencies that ensure quality, safety and effectiveness for the approval of new products and post-marketing compliance.

  3. The Productivity of Plain English.

    ERIC Educational Resources Information Center

    Department of Commerce, Washington, DC.

    Focusing on a meeting held in January 1983, this pamphlet describes the Forum on the Productivity of Plain English, from which grew the permanent Plain English Forum, which is committed to spreading the message that plain English is good business. The pamphlet includes quotations from leaders in business and industry explaining why they feel that…

  4. Direct-to-consumer advertising of prescription drugs: European Commission persists in putting industry's interests first.

    PubMed

    2013-01-01

    In late September 2010, Members of the European Parliament (MEPs) issued their verdict on European Commission proposals aimed at lifting the ban on pharmaceutical companies communicating directly with the general public about prescription drugs. The MEPs were able to limit the scope of some of the more harmful aspects of these proposals, in particular by proposing that drug regulatory agencies should pre-screen the "information" produced by drug companies before it is made available to the public. In December 2010, faced with ongoing opposition from European Member States, the Commission appeared to back down, announcing that it was drawing up "amended proposals". They were publicly released in February 2012 but still leave the door open to direct-to-consumer advertising of prescription drugs, particularly "reminder advertising". As of 4 July 2012, the amended proposals had not yet been examined by Member States, thus obstructing the legislative process. Public health and management of the costs of social services for Member States are at stake. The Medicines in Europe Forum (MiEF) and the International Society of Drug Bulletins (ISDB) urge Member States to continue to refuse to examine the Commission's proposals, and have drawn up concrete counterproposals that would enable the general public to obtain relevant health information.

  5. Where Are the Nanodrugs? An Industry Perspective on Development of Drug Products Containing Nanomaterials.

    PubMed

    Havel, Henry A

    2016-11-01

    While nanotechnology advancements have been applied to pharmaceutical products, the number of approved nanodrugs by global health authorities has not kept pace with research and development investments in the field. This article reviews the history of nanodrug development and provides an industrial context for realistic expectations in the future.

  6. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-06

    ...; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY... announcing the availability of a guidance for industry and FDA staff entitled ``Section 905(j) Reports... products before they may be marketed; alternatively, manufacturers may submit a 905(j) report intended...

  7. 76 FR 36133 - Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ... if: ``through either chemical reaction or intermolecular forces or both, the product mediates a... Issues; and Interpretation of the Term ``Chemical Action'' in the Definition of Device Under Section 201...'' and ``Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in the...

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

    PubMed

    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.

  9. The cost of multiple sclerosis drugs in the US and the pharmaceutical industry

    PubMed Central

    Bourdette, Dennis N.; Ahmed, Sharia M.; Whitham, Ruth H.

    2015-01-01

    Objective: 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. Methods: 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. Results: 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. Conclusions: 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. PMID:25911108

  10. Anaerobic treatment of wastewater with high suspended solids from a bulk drug industry using fixed film reactor (AFFR).

    PubMed

    Rao, A Gangagni; Naidu, G Venkata; Prasad, K Krishna; Rao, N Chandrasekhar; Mohan, S Venkata; Jetty, Annapurna; Sarma, P N

    2004-07-01

    Studies are carried out on the treatment of wastewater from a bulk drug industry using an anaerobic fixed film reactor (AFFR) designed and fabricated in the laboratory. The chemical oxygen demand (COD) and total dissolved solids (TDS) of the wastewater are found to be very high with low Biochemical oxygen demand (BOD) to COD ratio and high total suspended solid (TSS) concentration. Acclimatization of seed consortia and start up of the reactor is carried out by directly using the wastewater, which resulted in reducing the period of startup to 30 days. The reactor is studied at different organic loading rates (OLR) and it is found that the optimum OLR is 10 kg COD/m3/day. The wastewater under investigation, which is having considerable quantity of SS, is treated anaerobically without any pretreatment. The COD and BOD of the reactor outlet wastewater are monitored and reduction at steady state and optimum OLR is observed to be 60-70% of COD and 80-90% of BOD. The reactor is subjected to organic shock loads at two different OLR and it is observed that the reactor could withstand shocks and performance could be restored to normalcy at that OLR. The results obtained indicated that AFFR could be used efficiently for the treatment of wastewater from a bulk drug industry having high COD, TDS and TSS. Copyright 2003 Elsevier Ltd.

  11. Anaerobic treatment of wastewater with high suspended solids from a bulk drug industry using fixed film reactor (AFFR).

    PubMed

    Gangagni Rao, A; Venkata Naidu, G; Krishna Prasad, K; Chandrasekhar Rao, N; Venkata Mohan, S; Jetty, Annapurna; Sarma, P N

    2005-01-01

    Studies were carried out on the treatment of wastewater from a bulk drug industry using an anaerobic fixed film reactor (AFFR) designed and fabricated in the laboratory. The chemical oxygen demand (COD) and total dissolved solids (TDS) of the wastewater were found to be very high with low biochemical oxygen demand (BOD) to COD ratio and high total suspended solid (TSS) concentration. Acclimatization of seed consortia and startup of the reactor was carried out by directly using the wastewater, which resulted in reducing the period of startup to 30 days. The reactor was studied at different organic loading rates (OLR) and it was found that the optimum OLR was 10 kg COD/m(3)/day. The wastewater under investigation, which had a considerable quantity of SS, was treated anaerobically without any pretreatment. COD and BOD of the reactor outlet wastewater were monitored and at steady state and optimum OLR 60-70% of COD and 80-90% of BOD were removed. The reactor was subjected to organic shock loads at two different OLR and the reaction could withstand the shocks and performance could be restored to normalcy at that OLR. The results obtained indicated that AFFR could be used efficiently for the treatment of wastewater from a bulk drug industry having high COD, TDS and TSS.

  12. 76 FR 34999 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... Methicillin-Resistant Staphylococcus Aureus for Culture-Based Devices; Availability AGENCY: Food and Drug... Diagnostic Devices for the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture- Based... monitoring blood culture systems. This draft guidance is not final nor is it in effect at this time. DATES...

  13. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... proportions in the United States and more recently, worldwide. The morbidity and mortality associated with..., and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration...) Applications for Low Glucose Suspend (LGS) Device Systems,'' you may either send an e-mail request to...

  14. 75 FR 73106 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... Clostridium difficile; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... Clostridium difficile.'' This draft guidance document describes FDA's recommendations concerning 510(k... Clostridium difficile (C. difficile). This draft guidance is not final nor is it in effect at this time....

  15. 78 FR 57859 - Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-20

    ... determine the potential for a drug to disrupt the endocrine system. This draft guidance also discusses... compounds that have the potential to interfere with some aspect of the endocrine system of an organism or its progeny. Any component of the endocrine system can be a target of endocrine disruptors, although...

  16. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-11

    ... Container Is Not Made With Natural Rubber Latex; Availability AGENCY: Food and Drug Administration, HHS... to include in the labeling of a medical product to convey that natural rubber latex was not used as a... for inclusion in medical product labeling such as ``latex-free,'' ``does not contain natural...

  17. 78 FR 66744 - Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... electronic or written comments on the draft guidance by February 4, 2014. ADDRESSES: Submit written requests.... Submit electronic comments on the draft guidance to http://www.regulations.gov . Submit written comments... immunodeficiency virus/acquired immunodeficiency syndrome; and (3) new drugs that are active in the treatment of...

  18. 76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... Radiology Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... ``Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology...(k)) requirements for certain in vitro diagnostic and radiology devices under the regulations. This...

  19. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ... determine the type of marketing submission that may be required for postapproval changes to a combination... determine the type of marketing submission that may be required for postapproval changes to a combination... change to an approved, stand-alone drug, device, or biological product or its manufacturing process are...

  20. 76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for... Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document is intended to provide... to fulfill premarket clinical data requirements. This draft guidance is not final nor is it in...

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

    PubMed

    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%, p<0.0001), 'addressing unmet needs' (69%, p<0.05), 'reformulations belonging to Group 3'-that is, change in administration route (117%, p<0.001), and being a repurposed product with the 'same brand name' as the original product (65%, p<0.05). We found that the ability of the repurposed product to address unmet needs, a reformulation where the target product had a different

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

    PubMed Central

    Murteira, Susana; Millier, Aurélie; Toumi, Mondher

    2014-01-01

    Background 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. Objective 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. Methods 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. Results 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%, p<0.0001), ‘addressing unmet needs’ (69%, p<0.05), ‘reformulations belonging to Group 3’—that is, change in administration route (117%, p<0.001), and being a repurposed product with the ‘same brand name’ as the original product (65%, p<0.05). Conclusion We found that the ability of the repurposed product to address unmet needs

  3. A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products.

    PubMed

    Mathonet, Serge; Mahler, Hanns-Christian; Esswein, Stefan T; Mazaheri, Maryam; Cash, Patricia W; Wuchner, Klaus; Kallmeyer, Georg; Das, Tapan K; Finkler, Christof; Lennard, Andrew

    2016-01-01

    Regulatory monographs in Europe and the United States require drug products for parenteral administration to be "practically free" or "essentially free" of visible particles, respectively. Both terms have been used interchangeably and acknowledge the probabilistic nature of visual particle inspection. The probability of seeing a particle in a drug product container varies according to the size and nature of the particles as well as container and inspection conditions. Therefore, the term "without visible particles" can be highly misleading in the context of what is practically achievable. This may lead to differences in understanding between industry practitioners and regulatory agencies. Is this term intended to mean "zero particles", or is there any intention to distinguish between particle type such as "zero extraneous visible particles" or "zero proteinaceous particles"? Furthermore, how can "zero" particles as a criterion for release testing be reconciled with "practically free from particles" as stated in the definition and a low, justified level of proteinaceous particles after production?The purpose of this position paper is to review best practices in the industry in terms of visual inspection process and associated operator training, quality control sampling, testing, and setting acceptance criteria corresponding to "practically free of visible particles" and providing considerations when visible proteinaceous particles are deemed unavoidable. It also provides a brief overview of visible particle characterization and gives perspectives on patient safety. This position paper applies to biotechnology-derived drug products including monoclonal antibodies in late-phase development to licensed products. In the 2011 monoclonal antibody monograph revision, European Pharmacopoeia experts acknowledged that protein products may also contain proteinaceous particles at release or that protein particles may form during storage. Indeed, industry experience has

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

    PubMed

    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.

  5. A case in south-eastern France: a review of drug facilitated sexual assault in European and English-speaking countries.

    PubMed

    Dorandeu, Anne H; Pagès, Cheryl A; Sordino, Marie-Christine; Pépin, Gilbert; Baccino, Eric; Kintz, Pascal

    2006-07-01

    Drug facilitated sexual assaults (DFSA) have been increasingly reported in the medical literature since the 1980s but their legal recognition is more recent, at least in Europe. From a case treated in south-eastern France, whose judicial consequences were known, it seemed of interest to carry out an international study of jurisprudence concerning this type of rape. While from the medical viewpoint the drugs used are well-known and their presence can be clinically verified, the legal consequences of their use in subsequent criminal prosecution is less clear-cut. Some European countries have no jurisprudence in this area, while others consider the use of drugs as an aggravating circumstance. In France, it was only in 2003 that the first case of DFSA was truly punished by the judicial system, with considerable media attention. By contrast, in English-speaking countries, particularly the United States, the use of drugs to facilitate sexual assault has frequently been recognized in legislation and in criminal prosecutions. Prevention is fundamental and is recognised as demonstrated by campaigns in various countries.

  6. Public perceptions of the pharmaceutical industry and drug safety: implications for the pharmacovigilance professional and the culture of safety.

    PubMed

    Olsen, Axel K; Whalen, Matthew D

    2009-01-01

    A survey of the US public titled 'Consumer Perceptions on Drug Safety' was conducted in October 2006. The survey was undertaken at that time because of the heightened public awareness of drug safety concerns over rofecoxib (Vioxx(R)) and pediatric antidepressant use. The survey was designed with questions related to public perception of the pharmaceutical industry, the US FDA, Congress and whether the US public perceived there to be a safety crisis. The survey consisted of 1726 US men and women aged 18 years and over. The survey results showed that the FDA, Congress and US pharmaceutical companies are perceived as having a notable amount of responsibility to ensure safety (by 75%, 41% and 70% of respondents, respectively). Additionally, 96% of the survey respondents indicated that they had some level of concern about adverse reactions to prescription drugs that are taken as directed. Seventy-six percent of the respondents were 'fairly' to 'extremely' concerned about adverse reactions, while approximately 42% of the survey respondents' opinions ranged from 'somewhat distrusting' to 'strongly distrusting' of the pharmaceutical companies that develop drugs. These findings are comparable to those in surveys conducted by the Kaiser Family Foundation in 2005 and PriceWaterhouseCoopers in 2007. These surveys suggest that about half the respondents believe there is both the need and desire for reform in drug safety by the pharmaceutical industry and the FDA. In reports from 2006 and 2007, the Institute of Medicine challenges the healthcare system and the FDA to adopt the principles of the culture of safety. While there have been steps taken to address the recommendations of the reports, as exemplified by the FDA Amendment Act of 2007 and the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium, true reform across the life sciences sector will only come through broad adoption of these principles. Thus, it is particularly important for

  7. Delays in new drug applications in Japan and industrial R&D strategies.

    PubMed

    Hirai, Y; Kinoshita, H; Kusama, M; Yasuda, K; Sugiyama, Y; Ono, S

    2010-02-01

    The gap between Japan and both the United States (US) and the European Union (EU) with regard to access to new drugs is becoming a major issue in Japan. We analyzed the time lags involved in new drug application (NDA) and biological license application submissions in Japan, the US, and the EU in order to identify the causes of delayed access. The time lag related to submission of applications ("submission lag") was longer for in-licensed products and for non-Japanese companies. Factors related to costs of clinical studies and potential volumes of sales were not associated with the submission lag. A bridging strategy (extrapolative use of foreign clinical data in the clinical data package based on International Conference on Harmonisation guideline E5) seemed to reduce submission lag, but the association between the two diminished when the cause-and-effect relationship was specifically investigated. These results suggest that multinational companies are likely to place more emphasis on the choice of development strategies that successfully lead to their goal rather than on direct costs and expected sales when deciding to introduce their pharmaceutical products in Japan. Our findings indicate that the clinical development guidances that helps pharmaceutical companies decide on investment and strategies are also the key to narrowing the gap in access to new drugs.

  8. The drugs industry and peasant self-defence in a Peruvian cocaine enclave.

    PubMed

    van Dun, Mirella

    2012-11-01

    This article gives a detailed account of the cocaine industry and the related violence in the Peruvian Upper Huallaga. It is argued that in this cocaine producing region violence increased during state-led forced eradication operations of the coca plants. Most of the violent incidents were closely related to the diminishing cocaine industry, but they were also related to the actions of the state security forces. Instead of receiving support from the state's security apparatus, the population mobilized its own forces to fight the violence. As will be argued, the causes of violence in this cocaine enclave are part of a dynamic interaction amongst many factors - an interaction that is influenced by the local context, a partial state vacuum, and the social utility and the economic advantages of violence. One needs to be aware that motivations of those who engage in the violent behaviour can change over time, as underlying power structures are influenced by changes in local conditions. The study covers an in-depth account of events taking place in the Upper Huallaga during the years 2003-2007. The research material was collected by several ethnographical fieldwork methods.

  9. Drug reformulations and repositioning in the pharmaceutical industry and their impact on market access: regulatory implications

    PubMed Central

    Murteira, Susana; Millier, Aurélie; Ghezaiel, Zied; Lamure, Michel

    2014-01-01

    Background Repurposing has become a mainstream strategy in drug development, but it faces multiple challenges, amongst them the increasing and ever changing regulatory framework. This is the second study of a series of three-part publication project with the ultimate goal of understanding the market access rationale and conditions attributed to drug repurposing in the United States and in Europe. The aim of the current study to evaluate the regulatory path associated with each type of repurposing strategy according to the previously proposed nomenclature in the first article of this series. Methods From the cases identified, a selection process retrieved a total of 141 case studies in all countries, harmonized for data availability and common approval in the United States and in Europe. Regulatory information for each original and repurposed drug product was extracted, and several related regulatory attributes were also extracted such as, designation change and filing before or after patent expiry, among others. Descriptive analyses were conducted to determine trends and to investigate potential associations between the different regulatory paths and attributes of interest, for reformulation and repositioning cases separately. Results Within the studied European countries, most of the applications for reformulated products were filed through national applications. In contrast, for repositioned products, the centralized procedure was the most frequent regulatory pathway. Most of the repurposing cases were approved before patent expiry, and those cases have followed more complex regulatory pathways in the United States and in Europe. For new molecular entities filed in the United States, a similar number of cases were developed by serendipity and by a hypothesis-driven approach. However, for the new indication's regulatory pathway in the United States, most of the cases were developed through a hypothesis-driven approach. Conclusion The regulations in the United

  10. [Incentives and disincentives for research and development of new drugs by the pharmaceutical industry].

    PubMed

    Curcio, Pasqualina Curcio

    2008-10-01

    The authors present a model with factors that influence research and development decisions by the pharmaceutical industry: risk of disease transmission and possibility of control; case-fatality and the presence of cure or treatments; income; number of persons who demand the medicine; and opportunity costs for the company. Companies tend to invest in markets with inelastic demand (highly contagious diseases with no possibility of controlling transmission and/or very lethal diseases without treatment) and/or where there is a large population or high per capita income. Companies tend not to invest in markets where marginal costs exceed marginal income, particularly when costs increase permanently as a consequence of rising opportunity costs generated by foregoing profit in other markets. In such cases, policies to subsidize R&D are not effective, and policies must be orientated towards strengthening basic and applied research by public institutions.

  11. English Business Communication Skills Training Needs of Non-Native English-Speaking Managers: A Case in Taiwan.

    ERIC Educational Resources Information Center

    Tsui, Chia-Jung

    1992-01-01

    Discusses results of a survey of managers in high-technology industry in Taiwan regarding their needs for English business communication skills in the workplace. Finds that English conversation and English telephoning are the most urgently needed training courses. (SR)

  12. Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature

    PubMed Central

    Murteira, Susana; Ghezaiel, Zied; Karray, Slim; Lamure, Michel

    2013-01-01

    Background Medicinal products that have been developed and approved for one disease may be the object of additional clinical development in other disease areas or of additional pharmaceutical development for new and different formulations. The newly developed products can be named as repositioned or reformulated products, respectively. Market access of repositioned or reformulated products in Europe and the United States is an interesting object of study as it may provide clarity about which parameters are assessed and considered to bring added value, other than the molecule itself. As such, we aim to evaluate if the added value of repositioned or reformulated medicinal products can be systematically described, quantified, and predicted. As a first step toward investigating the impact of market access on drug research and development trends for repositioned and reformulated products, it is necessary to have consistency in the designations for the case studies evaluated in this project. In an attempt to achieve that consistency, the current study aims to propose harmonized definitions for the repositioning and reformulation strategies and to propose a taxonomy for the medicinal products derived thereof. Methods A systematic literature review was conducted to collect information on existing cases of repositioning or reformulation. A search strategy was developed by defining the search objectives, targeted data sources, search keywords, and inclusion/exclusion criteria for the retrieved documents. Results A total of 505 publications were retrieved through a search of the main data sources. The screenings and the ad hoc search led to a total of 56 publications to be used for the case study data extraction. In total, 87 repositioning and/or reformulation cases were found described in the literature, 23 of which presented different definitions and/or classifications by different authors. Conclusion Given the disparity and inconsistency of terminologies and

  13. Compliance with the new Food and Drug Administration regulations: an approach by industry.

    PubMed

    Ward, J W

    1981-09-01

    Good Laboratory Practice regulations became effective on June 20, 1979. The regulations provide guidance for the proper conduct and reporting of nonclinical laboratory studies on articles regulated by the United States Food and Drug Administration. A fundamental requirement of the regulations is the establishment of a quality assurance unit within each research facility to ensure the utilization and maintenance of good laboratory practices. A second significant feature is the requirement for an archival unit responsible for maintaining all raw data, documentation, protocols, specimens, and final reports. Experience with the regulations has been mixed. The quality of reports has been upgraded dramatically. Protocols contain more information than ever, data recording is more extensive and more carefully executed, and reports are prepared more carefully and edited more thoroughly. Conversely, there is no real evidence that quality of science has been improved, and costs have increased markedly.

  14. Biological treatment of steroidal drug industrial effluent and electricity generation in the microbial fuel cells.

    PubMed

    Liu, Ru; Gao, Chongyang; Zhao, Yang-Guo; Wang, Aijie; Lu, Shanshan; Wang, Min; Maqbool, Farhana; Huang, Qing

    2012-11-01

    The single chamber microbial fuel cells (MFCs) were used to treat steroidal drug production wastewater (SPW) and generate electricity simultaneously. The results indicated that the maximum COD removal efficiency reached 82%, total nitrogen and sulfate removal rate approached 62.47% and 26.46%, respectively. The maximum power density and the Coulombic efficiency reached to 22.3Wm(-3) and 30%, respectively. The scanning electron microscope showed that the dominant microbial populations were remarkably different in morphology on the surface of SPW and acetate-fed anodes. PCR-denaturing gradient gel electrophoresis profiles revealed that the microbial community structure fed with different concentrations of SPW presented a gradual succession and unique bacterial sequences were detected on the SPW and acetate-fed anodes. This research demonstrates that MFCs fed with SPW achieved a high efficiency of power density and simultaneous nutrient removal, and the dominant microorganisms on the anode were related to the types and the concentrations of substrates.

  15. [False pairs in expert registers: the word drug, its collocations and translation equivalents from English to Serbian language].

    PubMed

    Andjelić-Nikolendžić, Vesna

    2010-01-01

    The paper focuses on the problem of false pairs in English and Serbian languages, and the issues stemming from and related to this phenomenon. Special attention was given to false pairs in occupational registers, and particularly to the register of medical profession. The author gives a number of examples showing that translators often fail to perceive the differences in semantic fields covered by the pairs observed in the two languages, which may cause serious misunderstanding. While in everyday life such a misunderstanding can be a source of amusement or embarrassment, in scientific or academic registers it could have more serious consequences.

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

    PubMed

    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.

  17. Nonclinical reproductive toxicity testing requirements for drugs, pesticides, and industrial chemicals in India and China.

    PubMed

    Rao, K S; Dong, Jing

    2013-01-01

    India and China have booming chemical, agrochemical, and pharmaceutical industries. Both countries also represent expanding markets for foreign chemical and healthcare companies. All such products require reproductive toxicity testing before marketing. The ICH testing guidelines for medicinal products are not applicable in China and India. Nonetheless, reproductive toxicity studies designed and run to ICH principles are generally acceptable for submission. The Chinese guidelines take into consideration traditional Chinese medicines, which are usually mixtures. Likewise, the specific recommendations of India and China for the reproductive toxicity testing of chemicals and pesticides differ from those of the OECD and the USEPA. Again, studies performed in accordance with internationally recognized principles are usually acceptable for submission in both countries. The Chinese guideline for the reproductive toxicity testing of agrochemicals is currently under revision; the new version is expected to resemble more closely the requirements of the OECD and the USEPA. As a member of the OECD, India has conducted Good Laboratory Practice (GLP) inspection, accreditation, and monitoring activities since 2004. China has made several attempts to join the Council Decisions on Mutual Acceptance of Data in the Assessment of Chemicals since 2005. Currently 47 laboratories in China have been certified by the national GLP authorities. Several laboratories in China have also been recently been certified by OECD member countries as GLP compliant. In India, there are currently 23 GLP-Certified laboratories; about six of these are also AALAC accredited. The specific study designs specified in the guidelines of China and India for reproductive toxicity studies are described in detail in this chapter.

  18. Drugs.

    ERIC Educational Resources Information Center

    Hurst, Hunter, Ed.; And Others

    1984-01-01

    This document contains the third volume of "Today's Delinquent," an annual publication of the National Center for Juvenile Justice. This volume deals with the issue of drugs and includes articles by leading authorities in delinquency and substance abuse who share their views on causes and cures for the drug problem among youth in this country.…

  19. Industry practices and compliance with U.S. Food and Drug Administration guidelines among California sprout firms.

    PubMed

    Thomas, Jennifer L; Palumbo, Mary S; Farrar, Jeff A; Farver, Thomas B; Cliver, Dean O

    2003-07-01

    Since 1995, raw vegetable sprouts have been implicated as the vehicle of infection in 15 foodborne outbreaks involving Salmonella and 2 foodborne outbreaks involving Escherichia coli O157:H7. To reduce the numbers of sprout-related outbreaks, the U.S. Food and Drug Administration (FDA) published Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouting Seeds in 1999. Between October 2000 and April 2001, 61.5% (16 of 26) of the known commercial sprout firms in California were enrolled in a survey to evaluate the industry practices of California sprouting operations and to determine compliance with FDA guidelines. A standardized questionnaire was used to collect data on firm demographics and seed disinfection practices. Additionally, free chlorine levels in seed disinfection solutions were measured, and 48-h spent irrigation water samples were collected from each firm. The irrigation water was screened for Salmonella and E. coli O157:H7 with FDA-recommended test kits. Free chlorine levels in the treatment solutions ranged from 50 to 35,000 mg/liter (ppm), with a median of 14,000 mg/liter (ppm). Free chlorine levels were higher for firms producing alfalfa sprouts than for those producing only mung bean or soybean sprouts (P=0.03). Levels of free chlorine tended to be higher for firms using a calcium hypochlorite treatment solution than for firms using a sodium hypochlorite treatment solution (P=0.067). All 32 irrigation water samples screened for Salmonella tested negative. Of the irrigation water samples tested for E. coil O157:H7, 75% (24 of 32) tested negative, and 25% (8 of 32) tested presumptive positive. The eight presumptive positive samples were found to be negative after further testing. These results indicate that producers of alfalfa sprouts are generally achieving the FDA-recommended calcium hypochlorite level of 20,000 mg/liter (ppm), whereas mung bean sprout producers are not.

  20. Art English.

    ERIC Educational Resources Information Center

    Preece, Robert

    1994-01-01

    Art English is a combination of English-as-a-Second-Language (ESL)/English-as-a-Foreign-Language (EFL) and art content. As a new instructional area, it faces several challenges: as with all English for Special Purposes (ESP), exchange of information among programs; development of a suitable combination of art content and ESL, due to lack of…

  1. Art English.

    ERIC Educational Resources Information Center

    Preece, Robert

    1994-01-01

    Art English is a combination of English-as-a-Second-Language (ESL)/English-as-a-Foreign-Language (EFL) and art content. As a new instructional area, it faces several challenges: as with all English for Special Purposes (ESP), exchange of information among programs; development of a suitable combination of art content and ESL, due to lack of…

  2. 76 FR 5387 - Guidance for Industry and Food and Drug Administration Staff; “`Harmful and Potentially Harmful...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

    ... Food, Drug, and Cosmetic Act''; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' This guidance provides written guidance to... Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' The Agency...

  3. FDA Revisits Rules on Drug and Device Communication: Will the Agency Relax Existing Industry-Opposed Restrictions?

    PubMed

    Barlas, Stephen

    2017-03-01

    The Food and Drug Administration issued draft guidances in January that tackled health care economic information and product labeling. Do these publications indicate a potential shift in on- and off-label policies for drugs and devices?

  4. FDA devotes new resources to upgrading generic drug safety: but in some instances, the industry is pushing back.

    PubMed

    Barlas, Stephen

    2014-05-01

    The Food and Drug Administration, concerned about the quality of the generic drugs that represent 84 percent of U.S. prescriptions, is looking more closely at foreign manufacturing plants and weighing other changes in the generic approval process.

  5. Perspectives on World English.

    ERIC Educational Resources Information Center

    Nelson, Cecil L.

    1988-01-01

    English is the most widely used language for commerce, industrial expansion, diplomacy, science, and other fields. As speakers of other languages adapt it to their purposes, educators must adjust their perceptions of how the language is used. This idea, and related ones, are discussed in this article. (JL)

  6. Perspectives on World English.

    ERIC Educational Resources Information Center

    Nelson, Cecil L.

    1988-01-01

    English is the most widely used language for commerce, industrial expansion, diplomacy, science, and other fields. As speakers of other languages adapt it to their purposes, educators must adjust their perceptions of how the language is used. This idea, and related ones, are discussed in this article. (JL)

  7. Coalition Priorité Cancer and the Pharmaceutical Industry in Quebec: Conflicts of Interest in the Reimbursement of Expensive Cancer Drugs?

    PubMed Central

    Hughes, David; Williams-Jones, Bryn

    2013-01-01

    In the context of scarce public resources, patient interest groups have increasingly turned to private organizations for financing, including the pharmaceutical industry. This practice puts advocacy groups in a situation of potential conflicts between the interests of patients and those of the drug companies. The interests of patients and industry can converge on issues related to the approval and reimbursement of medications. But even on this issue, interests do not always align perfectly. Using the Quebec example of Coalition Priorité Cancer (CPC) as a case study, we examine the ethical issues raised by such financial relationships in the context of drug reimbursement decision-making. We collected, compiled and analyzed publicly available information on the CPC's organization and activities; this approach allowed us to raise and discuss important questions regarding the possible influence exerted on patient groups by donors. We conclude with some recommendations. PMID:23968674

  8. Coalition Priorité Cancer and the pharmaceutical industry in Quebec: conflicts of interest in the reimbursement of expensive cancer drugs?

    PubMed

    Hughes, David; Williams-Jones, Bryn

    2013-08-01

    In the context of scarce public resources, patient interest groups have increasingly turned to private organizations for financing, including the pharmaceutical industry. This practice puts advocacy groups in a situation of potential conflicts between the interests of patients and those of the drug companies. The interests of patients and industry can converge on issues related to the approval and reimbursement of medications. But even on this issue, interests do not always align perfectly. Using the Quebec example of Coalition Priorité Cancer (CPC) as a case study, we examine the ethical issues raised by such financial relationships in the context of drug reimbursement decision-making. We collected, compiled and analyzed publicly available information on the CPC's organization and activities; this approach allowed us to raise and discuss important questions regarding the possible influence exerted on patient groups by donors. We conclude with some recommendations.

  9. 78 FR 54899 - Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... Facility Identifier System for Drug Establishment Registration; Availability AGENCY: Food and Drug...) System for Drug Establishment Registration.'' This draft guidance specifies the UFI system for... and Innovation Act (FDASIA). DATES: Although you can comment on any guidance at any time (see 21 CFR...

  10. 78 FR 38058 - Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... Assay (hMRTA),'' on the Internet at http://www.fda.gov/AnimalVeterinary/ScienceResearch/ToolsResources..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4257, Silver...

  11. 75 FR 32952 - Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... the Federal Food, Drug, and Cosmetic Act''; Availability AGENCY: Food and Drug Administration, HHS... Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance... Cosmetic Act.'' This draft guidance, when finalized, will discuss the meaning of the term ``harmful and...

  12. 77 FR 12311 - Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-29

    ... applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current thinking on appropriate size... submitting NDAs, ANDAs, and BLAs CDER's current thinking on appropriate size ranges for beads in drug... guidance represents the Agency's current thinking on the size of beads in drug products labeled...

  13. The Effects of Paper-Based Portfolios and Weblog-Based Electronic Portfolios on Limited English Proficiency Students in Writing for Service Industry Course

    ERIC Educational Resources Information Center

    Wanchid, Raveewan; Charoensuk, Valaikorn

    2015-01-01

    The purposes of this study were to investigate the effects of the use of paper-based and weblog-based electronic portfolios on the writing achievement of limited English proficiency students, to survey the students' attitudes towards the use of the portfolio assessment, and to compare the viewpoints of the students in the control and experimental…

  14. Career Education: Learning with a Purpose. Secondary Guide-Vol. 1. Art, English, Industrial Arts, Physical Education, Science, Field Trips and Guest Speakers.

    ERIC Educational Resources Information Center

    Atkinson, Marilyn; And Others

    The guide offers a compilation of teacher developed career education materials which may be integrated with secondary level curriculum and, in some cases, complete unit or course outlines are included. Suggested activities and ideas are presented for the following five subject areas and their related units: art, English (activity suggestions for…

  15. English for Tourism and Hospitality Purposes (ETP)

    ERIC Educational Resources Information Center

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

    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…

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

    PubMed

    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 TiO2 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.

  17. New drug regulations in France: what are the impacts on market access? Part 2 – impacts on market access and impacts for the pharmaceutical industry

    PubMed Central

    Rémuzat, Cécile; Toumi, Mondher; Falissard, Bruno

    2013-01-01

    Access to the French drug market is being impacted by an ongoing dramatic shift in practice as well as by two laws that came into force in December 2011. This new environment has been described and analyzed in two separate articles. This second article analyzes how this new environment will actually impact the access to French drug market. French drug market access will be increasingly driven by comparative-effectiveness and cost-effectiveness data, and an increased role of postmarketing studies in the years to come. This access is evolving in a more complex environment for stakeholders due to the uncertainties surrounding these changes and it will be more complex and difficult for the pharmaceutical industry to address. The main issue faced by the pharmaceutical companies will be to minimize uncertainty at the time of a drug's launch to narrow the decision window. This is a major change of paradigm for the pharmaceutical business, in which pre- and postlaunch risks are directed toward the pharmaceutical industry. PMID:27226829

  18. Transnational industrial power, the medical profession and the regulatory state: adverse drug reactions and the crisis over the safety of Halcion in the Netherlands and the UK.

    PubMed

    Abraham, John

    2002-11-01

    Taking the controversy over the safety of the hypnotic, Halcion, in the Netherlands and the UK, as a case study, this article examines the problems for public health associated with responses to warnings about drug hazards by regulatory agencies, governmental expert advisers, the pharmaceutical industry and the medical profession. It is argued that regulators and the medical profession rely too heavily on manufacturers to investigate warnings from doctors' spontaneous reporting of adverse effects of drug products on the market. It is demonstrated that a pharmaceutical firm's commitment to search effectively for evidence against the safety of its own product in order to confirm doctors' warnings can have severe limitations. Deficiencies in the socio-institutional responses to post-market 'early warning systems' about drug hazards imply that the regulatory policies of 'early licensing' and minimal pre-market checks for new drugs are misconceived and threaten public health. To improve public protection from drug injury, the regulators should abandon their conviction that compelling evidence of drug hazards are required to confirm doctors' warning signals prior to regulatory intervention. Instead, they should adopt a policy of measured regulatory intervention as an immediate response to warning signals, while investigators, independent of the manufacturers, assess the significance of the signal.

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

    PubMed

    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.

  20. Teaching English.

    ERIC Educational Resources Information Center

    Nemanich, Donald, Ed.

    1975-01-01

    Articles in this volume of the "Illinois English Bulletin" include "Competencies in Teaching English" by Alan C. Purves, which sets forth a tentative model for planning competency-based instruction and certification based on concepts, teaching acts, skills, and strategies; "Passing the Buck Versus the Teaching of English" by Dennis Q. McInerny,…

  1. Earphone English.

    ERIC Educational Resources Information Center

    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…

  2. Earphone English.

    ERIC Educational Resources Information Center

    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…

  3. Comparison of problematic behaviours of 10th and 11th year Southern English adolescents. Part 2: Current drink, drug and sexual activity of children with smoking parents.

    PubMed

    Cox, Malcolm; Pritchard, Colin

    2007-01-01

    To determine parental and school influences upon the behaviour and attitudes of adolescents of smoking versus non-smoking parents and of those "liking and disliking" school. Utilising a self-administered confidential standardised questionnaire, a representative sample of Southern English 10th and 11th year secondary school pupils was obtained. Current drink, drug and sexual behaviour were explored and data on adolescents whose parents smoked was extrapolated and compared against adolescents of non-smoking parents. Pupils reporting "liking school" were compared against those "not liking school" and all results statistically analysed. There were 17% smoking mothers [SM] and 23% smoking fathers [SF]. The focus is upon students of SF whose adolescents are significantly more often engaged in substance misuse (38-18%), drinking in pubs (31%-15%), binge drinking (32%-18%), and under-age sexual activity (27%-14%) plus smoking (51%-32%), truanting (43%-23%), vandalism (32%-22%) and stealing (19%-11%). SM students had higher incidence of sexual behaviour (33%-13%) and unprotected sex (21%-6%). Students of smoking parents were less well informed and had significantly more negative attitudes about social behaviour and responsibility. "Liking school" was associated to significantly lower rates of problematic behaviour, which predominately was not related to the social background of the pupils. The smoking father criteria carries a social class bias, nonetheless these parents need to be aware of the particular behaviour of their children and their increased risk. SF do not "cause" the behaviour rather it reflects something of the nature of the adolescent's relationship to parents, school and society.

  4. Nasal-to-CNS drug delivery: where are we now and where are we heading? An industrial perspective.

    PubMed

    Landis, Margaret S; Boyden, Tracey; Pegg, Simon

    2012-02-01

    Delivery of drug therapeutics across the blood-brain barrier is a challenging task for pharmaceutical scientists. Nasal-to-CNS drug delivery has shown promising results in preclinical efficacy models and investigatory human clinical trials. The further development of this technology with respect to the establishment of valid, predictable preclinical species models, translatable pharmacokinetic-pharmacodynamic relationships and definition of toxicology impact will help attract additional pharmaceutical investment in this drug-delivery approach. Further discoveries in nasal nanotechnology, targeted delivery devices and diagnostic olfactory imaging will serve to fuel the advancements in this area of drug delivery.

  5. 76 FR 13629 - Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401... Food, Drug, and Cosmetic Act (the FD&C Act). This revised draft guidance describes the types of waivers...ComplianceRegulatoryInformation/Guidances/default.htm ,...

  6. Influence of kidney disease on drug disposition: An assessment of industry studies submitted to the FDA for new chemical entities 1999-2010.

    PubMed

    Matzke, Gary R; Dowling, Thomas C; Marks, Samantha A; Murphy, John E

    2016-04-01

    In 1998, the United States Food and Drug Administration (FDA) released the first guidance for industry regarding pharmacokinetic (PK) studies in renally impaired patients. This study aimed to determine if the FDA renal PK guidance influenced the frequency and rigor of renal studies conducted for new chemical entities (NCEs). FDA-approved package inserts (APIs) and clinical pharmacology review documents were analyzed for 194 NCEs approved from 1999 to 2010. Renal studies were conducted in 71.6% of NCEs approved from 1999 to 2010, a significant increase over the 56.3% conducted from 1996 to 1997 (P = .0242). Renal studies were more likely to be completed in highly renally excreted drugs (fe ≥ 30%) compared with drugs with low renal excretion, fe < 30% (89.6% vs 65.8%, P = .0015). PK studies to assess the impact of dialysis were conducted for 31.7% of NCEs that had a renal study: a greater proportion of high fe NCEs were studied (44.2% vs 26.0%, P = .0335). No significant change in frequency or rigor of PK studies was detected over time. The majority of NCEs (76.3%) with a renal study provided specific dosing recommendations in the API. The adoption of the 1998 FDA guidance has resulted in improved availability of PK and drug-dosing recommendations, particularly for high fe drugs. © 2015, The American College of Clinical Pharmacology.

  7. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ... Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using... industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.'' The draft guidance is intended to describe best...

  8. The combination of glycerol metabolic engineering and drug resistance marker-aided genome shuffling to improve very-high-gravity fermentation performances of industrial Saccharomyces cerevisiae.

    PubMed

    Wang, Pin-Mei; Zheng, Dao-Qiong; Liu, Tian-Zhe; Tao, Xiang-Lin; Feng, Ming-Guang; Min, Hang; Jiang, Xin-Hang; Wu, Xue-Chang

    2012-03-01

    A challenge associated with the ethanol productivity under very-high-gravity (VHG) conditions, optimizing multi-traits (i.e. byproduct formation and stress tolerance) of industrial yeast strains, is overcome by a combination of metabolic engineering and genome shuffling. First, industrial strain Y12 was deleted with a glycerol exporter Fps1p and hetero-expressed with glyceraldehydes-3-phosphate dehydrogenase, resulting in the modified strain YFG12 with lower glycerol yield. Second, YFG12 was subjected to three rounds of drug resistance marker-aided genome shuffling to increase its ethanol tolerance, and the best shuffled strain TS5 was obtained. Compared with wild strain Y12, shuffled strain TS5 not only decreased glycerol formation by 14.8%, but also increased fermentation rate and ethanol yield by 3.7% and 7.6%, respectively. Moreover, the system of genetic modification and Cre/loxP in aid of three different drug-resistance markers presented in the study significantly improved breeding efficiency and will facilitate the application of breeding technologies in prototrophic industrial microorganisms.

  9. The innovative use of a large-scale industry biomedical consortium to research the genetic basis of drug induced serious adverse events.

    PubMed

    Holden, Arthur L

    2007-01-01

    The International Serious Adverse Event Consortium (SAEC) is a pharmaceutical industry and FDA led international (501 c3 non-profit) consortium, focused on identifying and validating DNA-variants useful in predicting the risk of drug induced, rare serious adverse events (SAEs). As such, it functions with the explicit purpose of enhancing the 'public good'. Its members are (i) organizations engaged principally in the business of discovering, developing and marketing pharmaceutical products, or (ii) a charitable, governmental, or other non-profit organization with an interest in researching the molecular basis of drug response.Drug-induced, rare SAEs present significant health issues for patients; and pose challenges for the safe use of approved drugs and the development of new drugs. Examples of drug-induced, rare SAEs include hepatotoxicity, QT prolongation, rhabdomyolosis, serious skin rashes (e.g. SJS), edema, acute renal failure, acute hypersensitivity, anemias/neutropenias, excessive weigh gain, retinopathy, vasculitis, among others. The rarity of such drug induced SAEs and the absence of effective government surveillance/research networks, makes it extremely difficult for any one company or research entity to accrue enough SAE cases and controls to conduct effective whole genome studies. Central to the notion of the SAEC is industry, government and health care providers can join forces to make use of a variety of sample and data resources in researching the genetic basis of these events.The purpose of the SAEC is threefold:•To carry out research directed toward the discovery of DNA-variants clinically useful in understanding and predicting the risk of drug induced serious adverse events and similar scientific research.•To ensure the widespread availability of the results of such research to the scientific research community and the public at large for no charge through publication and web-based methods; and•To educate the scientific research and medical

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

    PubMed

    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.

  11. Industrial lab-on-a-chip: design, applications and scale-up for drug discovery and delivery.

    PubMed

    Vladisavljević, Goran T; Khalid, Nauman; Neves, Marcos A; Kuroiwa, Takashi; Nakajima, Mitsutoshi; Uemura, Kunihiko; Ichikawa, Sosaku; Kobayashi, Isao

    2013-11-01

    Microfluidics is an emerging and promising interdisciplinary technology which offers powerful platforms for precise production of novel functional materials (e.g., emulsion droplets, microcapsules, and nanoparticles as drug delivery vehicles- and drug molecules) as well as high-throughput analyses (e.g., bioassays, detection, and diagnostics). In particular, multiphase microfluidics is a rapidly growing technology and has beneficial applications in various fields including biomedicals, chemicals, and foods. In this review, we first describe the fundamentals and latest developments in multiphase microfluidics for producing biocompatible materials that are precisely controlled in size, shape, internal morphology and composition. We next describe some microfluidic applications that synthesize drug molecules, handle biological substances and biological units, and imitate biological organs. We also highlight and discuss design, applications and scale up of droplet- and flow-based microfluidic devices used for drug discovery and delivery. © 2013.

  12. 78 FR 55261 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. DATES... launch of the GDUFA program, FDA has revised the draft guidance and is issuing it again in draft...

  13. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-20

    ...; Class II Special Controls; Guidance Document: Topical Oxygen Chamber for Extremities; Availability... Drug Administration Staff; Class II Special Controls Guidance Documents: Topical Oxygen Chamber for... Guidance Document: Topical Oxygen Chamber for Extremities'' to the Division of Small...

  14. 77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ...-Bore Connectors Intended for Enteral Applications; Availability AGENCY: Food and Drug Administration... Misconnections with Small- bore Connectors Intended for Enteral Applications.'' The use of common connector... Risks of Misconnections With Small-Bore Connectors Intended for Enteral Applications'' to the...

  15. 77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... thinking on the use of medically important antimicrobial drugs in animal agriculture. DATES: Submit either... the Agency's current thinking on the topic. It does not create or confer any rights for or on any...

  16. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Electrocardiograph Electrodes.'' The special controls identify the following risks to health... Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph...

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

    PubMed

    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.

  18. Le lexique anglais-francais de l'industrie miniere de l'Office de la langue francaise (The English-French Lexicon of the Mining Industry prepared by the Office of the French Language)

    ERIC Educational Resources Information Center

    Rousseau, Louis-Jean

    1974-01-01

    This article describes research methods involved in compiling a lexicon of terms used in the mining industry. This consisted mainly in contrasting terms found in dictionaries with actual usage in spoken and written language. (Text is in French) (AM)

  19. NIMH Initiatives to Facilitate Collaborations between Industry, Academia and Government for the Discovery and Clinical Testing of Novel Models and Drugs for Psychiatric Disorders

    PubMed Central

    Brady, Linda S.; Winsky, Lois; Goodman, Wayne; Oliveri, Mary Ellen; Stover, Ellen

    2008-01-01

    There is an urgent need to transform basic research discoveries into tools for treatment and prevention of mental illnesses. This article presents an overview of the National Institute of Mental Health (NIMH) programs and resources to address the challenges and opportunities in psychiatric drug development starting at the point of discovery through the early phases of translational research. We summarize NIMH and selected National Institutes of Health (NIH) efforts to stimulate translation of basic and clinical neuroscience findings into novel targets, models, compounds, and strategies for the development of innovative therapeutics for psychiatric disorders. Examples of collaborations and partnerships between NIMH/NIH, academia, and industry are highlighted. PMID:18800066

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

    PubMed

    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

  1. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil Money... responses to questions FDA has received regarding the issuance of civil money penalties for violations of...

  2. 78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry... guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This draft guidance is to inform... and Radiological Health's (CDRH) proposed approach on the safety of toy laser products. This draft...

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

    PubMed

    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.

  4. What Are Drugs?

    ERIC Educational Resources Information Center

    Minnesota Police and Peace Officers Association.

    This guide for parents presents, in Laotian and English, information about drugs, drug use and abuse, and treatment for drug use. Most of the information is presented in question and answer form to give parents the information they need to answer their children's questions and help prevent drug use. The following sections are included: (1)…

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

    PubMed Central

    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

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

    PubMed

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

    2017-02-07

     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.  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10.  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany.  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.  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.  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 strictly obliged to maintain confidentiality towards the

  7. ''I'd Love to Put Someone in Jail for This:" An Initial Investigation of English in the Business Processing Outsourcing (BPO) Industry

    ERIC Educational Resources Information Center

    Forey, Gail; Lockwood, Jane

    2007-01-01

    In the global workplace, there has been tremendous growth in business processing outsourcing (BPO). Many industries are establishing call centers, back offices and other offshore enterprises in developing countries in an attempt to reduce costs. This development has far-reaching implications for language in these offshore destinations. Despite…

  8. Lexicogrammar in the International Construction Industry: A Corpus-Based Case Study of Japanese-Hong-Kongese On-Site Interactions in English

    ERIC Educational Resources Information Center

    Handford, Michael; Matous, Petr

    2011-01-01

    The purpose of this research is to identify and interpret statistically significant lexicogrammatical items that are used in on-site spoken communication in the international construction industry, initially through comparisons with reference corpora of everyday spoken and business language. Several data sources, including audio and video…

  9. Lexicogrammar in the International Construction Industry: A Corpus-Based Case Study of Japanese-Hong-Kongese On-Site Interactions in English

    ERIC Educational Resources Information Center

    Handford, Michael; Matous, Petr

    2011-01-01

    The purpose of this research is to identify and interpret statistically significant lexicogrammatical items that are used in on-site spoken communication in the international construction industry, initially through comparisons with reference corpora of everyday spoken and business language. Several data sources, including audio and video…

  10. ''I'd Love to Put Someone in Jail for This:" An Initial Investigation of English in the Business Processing Outsourcing (BPO) Industry

    ERIC Educational Resources Information Center

    Forey, Gail; Lockwood, Jane

    2007-01-01

    In the global workplace, there has been tremendous growth in business processing outsourcing (BPO). Many industries are establishing call centers, back offices and other offshore enterprises in developing countries in an attempt to reduce costs. This development has far-reaching implications for language in these offshore destinations. Despite…

  11. Maori English

    ERIC Educational Resources Information Center

    Maclagan, Margaret; King, Jeanette; Gillon, Gail

    2008-01-01

    The Maori language is the language of the indigenous people of New Zealand. Today, not all Maori speak the Maori language, and many Maori as well as non-Maori speak Maori English, the fastest growing of the main varieties of New Zealand English. This paper provides a background to the linguistic situation of the Maori populace in New Zealand,…

  12. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... explains who is required to self- identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify. DATES: Although you can... and compliance. This guidance is intended to assist human generic drug facilities, sites, and...

  13. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ... Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug... marketing clearance for a new x-ray imaging device with a pediatric indication should provide data... marketing clearance only for general indications or do not submit adequate data to the FDA to support...

  14. 76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug... Pulse Generator.'' This draft guidance document describes a means by which external pacemaker pulse generators may comply with the requirement of special controls for class II devices. This draft guidance is...

  15. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-18

    ... Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability.... Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with the requirement of special controls for class II devices...

  16. 76 FR 36543 - Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability... and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize... Factors and Usability Engineering to Optimize Medical Device Design'' to the Division of Small...

  17. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-19

    ... licensing applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current thinking on... provides sponsors of NDAs, ANDAs, and BLAs CDER's current thinking on appropriate size ranges for beads in...). The draft guidance, when finalized, will represent the Agency's current thinking on size of beads in...

  18. 76 FR 26307 - Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... Applications.'' The guidance is intended to assist abbreviated new drug application (ANDA) applicants in... the Federal Register in January 2009 (74 FR 2849, January 16, 2009). The final rule requires ANDA... subjects: Types of ANDA submissions covered by the regulations on BE studies; Recommended format...

  19. 77 FR 11550 - Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... to voluntarily notify the Agency of potential disruptions to supply of a prescription product that... or disruption in supply of a drug or biological product, and to address other issues, such as quality control and contingency planning related to product shortages or potential disruption in supply. This...

  20. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS... draft guidance entitled ``Refuse to Accept Policy for 510(k)s.'' The purpose of this document is to... (510(k)) submission is administratively complete, which determines whether it should be accepted...

  1. The production and R&D structure of the Brazilian pharmaceutical industry: the role of public procurement and public drug production.

    PubMed

    Sorte Junior, Waldemiro Francisco

    2012-01-01

    This article examines the use of governmental purchasing power and public laboratories to stimulate domestic production and research and development (R&D) activities in the Brazilian pharmaceutical industry. Three main areas in which public laboratories can play an important role are identified: (1) large-scale production of essential medications; (2) production of strategic drugs to reduce the trade deficit in the health sector; and (3) in-house research efforts and stimulation of R&D in the private sector through public-private partnerships (PPPs). The analysis of the production and R&D structure of the Brazilian pharmaceutical industry tends to show that the Ministry of Health (MOH) purchasing power can be used to nurture the growth of public laboratories and generate positive externalities for the private sector. Nonetheless, fieldwork data reveal that the lack of alignment between health policies and public laboratories' production are resulting in idle production capacity. In order for the current governmental strategy to promote industrial growth, there should be a division of tasks among public laboratories within a long-term framework, based on a stable set of priorities from the MOH.

  2. Evaluation of CYP2B6 Induction and Prediction of Clinical Drug-Drug Interactions: Considerations from the IQ Consortium Induction Working Group-An Industry Perspective.

    PubMed

    Fahmi, Odette A; Shebley, Mohamad; Palamanda, Jairam; Sinz, Michael W; Ramsden, Diane; Einolf, Heidi J; Chen, Liangfu; Wang, Hongbing

    2016-10-01

    Drug-drug interactions (DDIs) due to CYP2B6 induction have recently gained prominence and clinical induction risk assessment is recommended by regulatory agencies. This work aimed to evaluate the potency of CYP2B6 versus CYP3A4 induction in vitro and from clinical studies and to assess the predictability of efavirenz versus bupropion as clinical probe substrates of CYP2B6 induction. The analysis indicates that the magnitude of CYP3A4 induction was higher than CYP2B6 both in vitro and in vivo. The magnitude of DDIs caused by induction could not be predicted for bupropion with static or dynamic models. On the other hand, the relative induction score, net effect, and physiologically based pharmacokinetics SimCYP models using efavirenz resulted in improved DDI predictions. Although bupropion and efavirenz have been used and are recommended by regulatory agencies as clinical CYP2B6 probe substrates for DDI studies, CYP3A4 contributes to the metabolism of both probes and is induced by all reference CYP2B6 inducers. Therefore, caution must be taken when interpreting clinical induction results because of the lack of selectivity of these probes. Although in vitro-in vivo extrapolation for efavirenz performed better than bupropion, interpretation of the clinical change in exposure is confounded by the coinduction of CYP2B6 and CYP3A4, as well as the increased contribution of CYP3A4 to efavirenz metabolism under induced conditions. Current methods and probe substrates preclude accurate prediction of CYP2B6 induction. Identification of a sensitive and selective clinical substrate for CYP2B6 (fraction metabolized > 0.9) is needed to improve in vitro-in vivo extrapolation for characterizing the potential for CYP2B6-mediated DDIs. Alternative strategies and a framework for evaluating the CYP2B6 induction risk are proposed.

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

    PubMed

    Esmaeili, Akbar; Behzadi, Sahar

    2017-07-18

    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.

  4. Current Approaches for Absorption, Distribution, Metabolism, and Excretion Characterization of Antibody-Drug Conjugates: An Industry White Paper.

    PubMed

    Kraynov, Eugenia; Kamath, Amrita V; Walles, Markus; Tarcsa, Edit; Deslandes, Antoine; Iyer, Ramaswamy A; Datta-Mannan, Amita; Sriraman, Priya; Bairlein, Michaela; Yang, Johnny J; Barfield, Matthew; Xiao, Guangqing; Escandon, Enrique; Wang, Weirong; Rock, Dan A; Chemuturi, Nagendra V; Moore, David J

    2016-05-01

    An antibody-drug conjugate (ADC) is a unique therapeutic modality composed of a highly potent drug molecule conjugated to a monoclonal antibody. As the number of ADCs in various stages of nonclinical and clinical development has been increasing, pharmaceutical companies have been exploring diverse approaches to understanding the disposition of ADCs. To identify the key absorption, distribution, metabolism, and excretion (ADME) issues worth examining when developing an ADC and to find optimal scientifically based approaches to evaluate ADC ADME, the International Consortium for Innovation and Quality in Pharmaceutical Development launched an ADC ADME working group in early 2014. This white paper contains observations from the working group and provides an initial framework on issues and approaches to consider when evaluating the ADME of ADCs.

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

    PubMed

    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.

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

    PubMed Central

    2013-01-01

    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. PMID

  7. Early communication of drug safety concerns: a feasibility study on enhancing interaction between the pharmaceutical industry and regulators.

    PubMed

    Swain, Elizabeth; Morgan, Sarah; Brewster, Wendy; Kauser, Shahin

    2010-03-01

    The responsibility for monitoring the safety of marketed medicines is shared between regulatory authorities and the pharmaceutical industry and is underpinned by legal obligations on both sides. Both marketing authorisation holders (MAHs) and regulators initially evaluate and investigate potential safety concerns, and then work together on further review as appropriate. We wanted to test the feasibility of enhanced interaction between MAH and regulator via a regular monthly, two-way communication of potential safety concerns between the MAHs and the Medicines and Healthcare Products Regulatory Agency (MHRA). It was envisaged that such a process would aid prioritisation and planning by both parties, avoid duplication of effort and support a collaborative approach for decision making. Four MAHs took part in the pilot, which was conducted between July 2007 and June 2008. Potential safety concerns were exchanged on a monthly basis. The MAH/MHRA proposed a timeline for evaluation of each potential safety concern. The pilot did not include serious public health issues which are immediately reported to regulatory authorities. During the pilot, 136 potential safety concerns were exchanged. Thirteen per cent of these resulted in a change to product information for health professionals and patients. There was concurrence between the MAHs and MHRA on timelines proposed for evaluation. The pilot proved feasible for the companies involved and indicated potential benefits of a system for avoiding duplication of effort and supporting a collaborative approach to planning and prioritisation of investigation of potential safety concerns between pharmaceutical industry and regulatory authorities.

  8. Research and development costs for new drugs by therapeutic category. A study of the US pharmaceutical industry.

    PubMed

    DiMasi, J A; Hansen, R W; Grabowski, H G; Lasagna, L

    1995-02-01

    The clinical period (i.e. clinical trial and long term animal testing) development costs of a random sample of new chemical entities (NCEs) were examined for differences in average cost. All of the NCEs studied were first tested in humans between 1970 and 1982, and were classified for the purposes of the study by therapeutic class. The costs of unsuccessful projects were included with those of projects that resulted in US marketing approval. Including income forgone from expending funds before returns are earned ('time costs'), the capitalised (i.e. out-of-pocket plus time) clinical period costs per approved NCE were $US70, $US98, $US103 and $US163 million (1993 dollars) for anti-infective, cardiovascular, neuropharmacological and nonsteroidal anti-inflammatory drugs, respectively. Combining the data for all therapeutic categories, the mean clinical period cost per approved NCE was $US93 million. Omitting costs associated with unsuccessful projects, the mean capitalised clinical period costs for approved NCEs ranged from $US7.1 million (for topical steroids) to $US66.7 million (for cardiovascular agents) [1993 dollars]. The estimates of total clinical period costs per approved NCE depend on average out-of-pocket clinical phase costs, attrition rates across phases (i.e. the rates at which compounds drop out of active testing), the probability of marketing approval, and development and regulatory review times. Phase attrition and approval rates are the most important sources of variability in total clinical period costs between therapeutic categories. Development cost estimates by therapeutic category did not correlate strongly with US sales in the fifth year of marketing. Cardiovascular NCEs had much higher than average sales revenues, but clinical development costs for these drugs were only slightly above average. Conversely, nonsteroidal anti-inflammatory drugs attained average sales revenues, but had much higher than average development costs.

  9. How a patient advocacy group developed the first proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration.

    PubMed

    Furlong, Pat; Bridges, John F P; Charnas, Lawrence; Fallon, Justin R; Fischer, Ryan; Flanigan, Kevin M; Franson, Timothy R; Gulati, Neera; McDonald, Craig; Peay, Holly; Sweeney, H Lee

    2015-06-24

    Among the challenges confronting patients with rare diseases is a dearth of treatment options. The development of safe and effective new therapies is hampered by challenges associated with conducting clinical trials in small populations. In this article, we describe how the Duchenne muscular dystrophy community-led by Parent Project Muscular Dystrophy-created a proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration. This unprecedented undertaking involved a broad coalition of more than 80 stakeholders collaborating across nine time zones to produce a document in only 6 months. We hope that other rare disease communities and advocacy organizations can use our experience as a model for developing their own draft guidance documents.

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

    ERIC Educational Resources Information Center

    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…

  11. 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.

    PubMed

    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.

  12. 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

    PubMed Central

    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

  13. Rating the raters: assessing the quality of Hamilton rating scale for depression clinical interviews in two industry-sponsored clinical drug trials.

    PubMed

    Engelhardt, Nina; Feiger, Alan D; Cogger, Kenneth O; Sikich, Dawn; DeBrota, David J; Lipsitz, Joshua D; Kobak, Kenneth A; Evans, Kenneth R; Potter, William Z

    2006-02-01

    The quality of clinical interviews conducted in industry-sponsored clinical drug trials is an important but frequently overlooked variable that may influence the outcome of a study. We evaluated the quality of Hamilton Rating Scale for Depression (HAM-D) clinical interviews performed at baseline in 2 similar multicenter, randomized, placebo-controlled depression trials sponsored by 2 pharmaceutical companies. A total of 104 audiotaped HAM-D clinical interviews were evaluated by a blinded expert reviewer for interview quality using the Rater Applied Performance Scale (RAPS). The RAPS assesses adherence to a structured interview guide, clarification of and follow-up to patient responses, neutrality, rapport, and adequacy of information obtained. HAM-D interviews were brief and cursory and the quality of interviews was below what would be expected in a clinical drug trial. Thirty-nine percent of the interviews were conducted in 10 minutes or less, and most interviews were rated fair or unsatisfactory on most RAPS dimensions. Results from our small sample illustrate that the clinical interview skills of raters who administered the HAM-D were below what many would consider acceptable. Evaluation and training of clinical interview skills should be considered as part of a rater training program.

  14. The English Challenge. Final Report.

    ERIC Educational Resources Information Center

    Northern Virginia Community Coll., Alexandria.

    A federally-funded cooperative program of in-plant English language instruction for industry workers is reported. Partners in the program were Northern Virginia Community College (Alexandria) and BOAT/U.S., a national business providing goods and services to the boating public. This 60-week workplace literacy program was divided into five 12-week…

  15. Effects of Drug Use

    MedlinePlus

    ... work or losing a job trouble in relationships child abuse or neglect driving crashes arrests and jail Visit the Easy-to-Read Drug Facts webpages listed under Drugs That People Abuse to learn more about effects of specific drugs. Previous Index Next English Español ...

  16. "Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the Form FDA 356h, 'Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use;'" availability. Food and Drug Administration, HHS. Notice.

    PubMed

    1999-05-10

    The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h, 'Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use.'" This guidance document is intended to assist applicants in the preparation of the content and format of the chemistry, manufacturing, and controls (CMC) section and the establishment description section of a biologics license application (BLA), revised Form FDA 356h, for human blood and blood components intended for transfusion or for further manufacture. In addition, this guidance document provides assistance for the completion of the BLA. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiatives and the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to reduce unnecessary burdens for industry without diminishing public health protection.

  17. Living English

    ERIC Educational Resources Information Center

    Speight, Stephen

    1977-01-01

    The latest (July, 1976) edition of the "Concise Oxford Dictionary" is seen as "prescriptive," and of limited use to foreigners, since it lacks an international phonetic transcription. It is questioned whether sufficient treatment is given to new words, scientific words, non-British English, obscene language, change of meaning, and obsolescence.…

  18. Black English.

    ERIC Educational Resources Information Center

    Bailey, Charles-James N.

    This paper, presented as part of a military lecture series given by the Division of Continuing Education and Community Service Speakers' Bureau of the University of Hawaii to military personnel at Schofield Barracks and Fort Shafter, investigates the origins and present status of Black English. A discussion of early studies in the Gullah dialect…

  19. English Works!

    ERIC Educational Resources Information Center

    Rubin, Joan; And Others

    This set of materials include an interactive videotape and textbook program (tape not included here) for high-beginning and intermediate English-as-a-Second-Language (ESL) students in or about to enter the workplace. The materials provide instruction in communication skills essential for job success. The 10 video segments and corresponding student…

  20. Career English.

    ERIC Educational Resources Information Center

    Dependents Schools (DOD), Washington, DC. Pacific Area.

    Career English is a course planned to teach the fundamental communicative skills to students in a meaningful, motivational, practical way through the medium of career choice. The handbook is meant to be a supplementary tool for high school teachers. Phase 1 focuses on the fundamentals of basic grammar and basic writing; it is divided into seven…

  1. English Downfall

    ERIC Educational Resources Information Center

    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.

  2. English Downfall

    ERIC Educational Resources Information Center

    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.

  3. Reduction of multidrug-resistant and drug-susceptible Salmonella in ground beef and freshly harvested beef briskets after exposure to commonly used industry antimicrobial interventions.

    PubMed

    Hughes, M K; Yanamala, S; San Francisco, M; Loneragan, G H; Miller, M F; Brashears, M M

    2010-07-01

    Two separate studies were conducted to examine the differences in survivability of multidrug-resistant (MDR) and drug-susceptible Salmonella in fresh meats in a simulated industry environment. Beef trim from a commercial facility was inoculated with either MDR (AmpC phenotype) or drug-susceptible Salmonella (SUS) cocktails (10(6) CFU/ml). Antimicrobial interventions included 3% lactic acid (LA), 1,000 ppm of acidified sodium chloride (ASC), ambient water (AW), and an inoculated control with no intervention (CTRL). Each aliquot was ground and formed into patties and packaged using high-O(2) modified atmosphere packaging. Samples for microbiological evaluation were collected on days 0, 7, 10, and 14. In the second study, beef briskets were collected immediately after harvest. Inoculation and antimicrobial application were the same, except treatments were heated and there was an additional hot water treatment. All beef briskets were refrigerated, and samples were collected at 0, 6, and 24 h. For the first study, the overall effectiveness of the treatments (from most effective to least effective) was LA, ASC, CTRL, and AW. Significant differences were observed only between MDR and SUS Salmonella when AW was applied (P = 0.02), and bacterial loads with AW were significantly greater (P < 0.01) for MDR Salmonella. In the second study, the intervention effectiveness ranked LA, ASC, hot water, AW, and CTRL. Significant differences between MDR and SUS Salmonella levels were not detected for any intervention or sampling time point. These data indicate that MDR and SUS variants of Salmonella behave similarly in response to the antagonistic action of antimicrobials commonly used in beef facilities.

  4. Malaysia Promotes Excellence in English.

    ERIC Educational Resources Information Center

    Murugesan, Vinodini

    2003-01-01

    Highlights the role of English in Malaysia, English in the education system, students learning English, English teachers, instruction and the syllabus, inservice support, private English education, English in tertiary education, and opportunities for teachers in Malaysia. (VWL)

  5. Drugs, prisons, and harm reduction.

    PubMed

    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. English Teaching Profile: Malawi.

    ERIC Educational Resources Information Center

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

    The role and status of English instruction in Malawi is outlined. The role of English in Malawi as a whole, English instruction within the educational system, language teacher supply and training, and British support for English instruction in Malawi are reported. English is taught as a subject in primary school and is the language of instruction…

  7. Who Shall Teach English?

    ERIC Educational Resources Information Center

    Smith, Eugene

    Potential secondary school English teachers undergo a unique screening procedure at the University of Washington. The education faculty allows the English faculty to recommend qualified candidates for the English education program. Students considering teaching English as a career visit the English department's advisory office, where they complete…

  8. Plain English Helps the Financial Services Industry.

    ERIC Educational Resources Information Center

    McGrath, Matthew J.

    1987-01-01

    In examining documentation difficulties through user surveys, Citibank found that their many different accounts each had unique forms, and accounts were booked in different locations and currencies. New forms emerged with new types of accounts. Refinement efforts reduced the number of forms from 64 to 4. (Author/CH)

  9. English Channel

    NASA Technical Reports Server (NTRS)

    1984-01-01

    The cloud covered earthscape of Northern Europe demonstrates the difficulty of photographing this elusive subject from space. The English Channel (51.0N, 1.5E) separating the British Islands from Europe is in the center of the scene. The white cliffs of Dover on the SE coast of the UK, the Thames River estuary and a partial view of the city of London can be seen on the north side of the Channel while the Normandy coast of France is to the south.

  10. English Channel

    NASA Technical Reports Server (NTRS)

    1984-01-01

    The cloud covered earthscape of Northern Europe demonstrates the difficulty of photographing this elusive subject from space. The English Channel (51.0N, 1.5E) separating the British Islands from Europe is in the center of the scene. The white cliffs of Dover on the SE coast of the UK, the Thames River estuary and a partial view of the city of London can be seen on the north side of the Channel while the Normandy coast of France is to the south.

  11. A Structural History of English.

    ERIC Educational Resources Information Center

    Nist, John

    This book combines a traditional history-of-the-language approach with modern linguistic analysis to discuss the history of English from Old English through Middle English, Early Modern English, Authoritarian English, Mature Modern English, to American English. The book begins with a discussion of the present status and structure of English. Each…

  12. A Structural History of English.

    ERIC Educational Resources Information Center

    Nist, John

    This book combines a traditional history-of-the-language approach with modern linguistic analysis to discuss the history of English from Old English through Middle English, Early Modern English, Authoritarian English, Mature Modern English, to American English. The book begins with a discussion of the present status and structure of English. Each…

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

    ERIC Educational Resources Information Center

    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…

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

    ERIC Educational Resources Information Center

    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;…

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

    ERIC Educational Resources Information Center

    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…

  16. English Vocabulary Instruction for English Learners

    ERIC Educational Resources Information Center

    Manyak, Patrick C.; Bauer, Eurydice Bouchereau

    2009-01-01

    In this column Manyak and Bauer summarize key research addressing the English vocabulary development of English learners (ELs) and distill implications for instructional practice. First, the authors discuss several key studies that demonstrate the limitation of many ELs' English vocabulary knowledge and the negative impact of this limitation on…

  17. English Vocabulary Instruction for English Learners

    ERIC Educational Resources Information Center

    Manyak, Patrick C.; Bauer, Eurydice Bouchereau

    2009-01-01

    In this column Manyak and Bauer summarize key research addressing the English vocabulary development of English learners (ELs) and distill implications for instructional practice. First, the authors discuss several key studies that demonstrate the limitation of many ELs' English vocabulary knowledge and the negative impact of this limitation on…

  18. Pharmacist-industry relationships.

    PubMed

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

    2017-01-18

    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. English as "Tyrannosaurus Rex."

    ERIC Educational Resources Information Center

    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…

  20. English Teaching Profile: Ethiopia.

    ERIC Educational Resources Information Center

    British Council, London (England).

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

  1. English Teaching Profile: Singapore.

    ERIC Educational Resources Information Center

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

    This profile of the English language teaching situation in Singapore examines the role of English in society and in the educational system. It is noted: (1) that English is the most important of the four official languages, (2) that education is provided in the four languages on the primary and secondary levels, and (3) that English is the medium…

  2. ENGLISH AND THE DISADVANTAGED.

    ERIC Educational Resources Information Center

    FAGAN, EDWARD R., ED.

    PART 1 OF THIS COLLECTION OF ARTICLES BY THE STAFF AND PARTICIPANTS OF AN NDEA SUMMER INSTITUTE IN ENGLISH FOR DISADVANTAGED YOUTH DESCRIBES ATTITUDES AND VIEWPOINTS ON THE PLACE OF ENGLISH IN THE DAILY LIVES OF STUDENTS AND CONTAINS ARTICLES ON "ENGLISH FOR WHAT" BY CHARLES WEINGARTNER, "ENGLISH TEACHING AND DROP-OUTS" AND…

  3. On Observing World English.

    ERIC Educational Resources Information Center

    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)

  4. English Teaching in Argentina.

    ERIC Educational Resources Information Center

    Arazi, Blanca

    2002-01-01

    Examines the teaching of English in Argentina, a country that has had a myriad of English language teaching activities at all levels for many decades--mostly in British English. Looks at English in binational centers, in schools, and at the university level; methodological approach; language assessment; teacher training; and the current economic…

  5. English Teaching Profile: Mexico.

    ERIC Educational Resources Information Center

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

    This profile of the English language teaching situation in Mexico examines the role of English in society and in the educational system. It is noted that the extent to which English is used in Mexico is affected by the country's proximity to the United States. The educational system is described, with emphasis on English instruction which begins…

  6. The "New" English.

    ERIC Educational Resources Information Center

    DeBoer, John J.

    1968-01-01

    Recent trends in the English curriculum--little more than changes in emphases--do not constitute a utopian "new English." In fact, one trend, revealed in some current studies of the high school English curriculum, involves a return to the "old" tradition of instruction in the great masters of English and American literature. The studies imply a…

  7. English Teaching Profile: Ethiopia.

    ERIC Educational Resources Information Center

    British Council, London (England).

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

  8. The "New" English.

    ERIC Educational Resources Information Center

    DeBoer, John J.

    1968-01-01

    Recent trends in the English curriculum--little more than changes in emphases--do not constitute a utopian "new English." In fact, one trend, revealed in some current studies of the high school English curriculum, involves a return to the "old" tradition of instruction in the great masters of English and American literature. The studies imply a…

  9. English Teaching Profile: Yugoslavia.

    ERIC Educational Resources Information Center

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

    A review of the status of English language instruction in Yugoslavia 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. The review also covers the characteristics and training of English language instructors, the type and…

  10. English Teaching Profile: France.

    ERIC Educational Resources Information Center

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

    This review of the status of English language instruction in France provides an overview of the role of English in the society in general and outlines the status of English in the educational system at the elementary, secondary, higher, and vocational levels. The following topics are covered: instruction in English for special purposes, the…

  11. Conversational English Program, 2.

    ERIC Educational Resources Information Center

    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…

  12. English Teaching Profile: Senegal.

    ERIC Educational Resources Information Center

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

    This profile of the English language teaching situation in Senegal examines the role of English in society and in the educational system. It is noted that English is the principal foreign language studied, but that it is used very little as a means of communication. The English curriculum is described, especially the secondary school examinations,…

  13. Conversational English Program, 1.

    ERIC Educational Resources Information Center

    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…

  14. ENGLISH AND THE DISADVANTAGED.

    ERIC Educational Resources Information Center

    FAGAN, EDWARD R., ED.

    PART 1 OF THIS COLLECTION OF ARTICLES BY THE STAFF AND PARTICIPANTS OF AN NDEA SUMMER INSTITUTE IN ENGLISH FOR DISADVANTAGED YOUTH DESCRIBES ATTITUDES AND VIEWPOINTS ON THE PLACE OF ENGLISH IN THE DAILY LIVES OF STUDENTS AND CONTAINS ARTICLES ON "ENGLISH FOR WHAT" BY CHARLES WEINGARTNER, "ENGLISH TEACHING AND DROP-OUTS" AND…

  15. English for Teachers.

    ERIC Educational Resources Information Center

    Holt, Daniel D.; And Others

    The text for English as a second language is designed to help Peace Corps volunteers and Korean teachers of English improve English language instruction in South Korea. It is not a complete course, but a review of basic English grammar for use in classroom communication, designed as a basis for curriculum and materials development. Topics covered…

  16. Japanese Media in English.

    ERIC Educational Resources Information Center

    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)

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

    SciTech Connect

    Not Available

    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.

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

    SciTech Connect

    Not Available

    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.

  19. Catching Up with Europe: Speakers and Functions of English in Hungary.

    ERIC Educational Resources Information Center

    Petzold, Ruth; Berns, Margie

    2000-01-01

    Discusses the functional range of English and its penetration into Hungarian society and shows that in just a few years English has become an essential tool for modernization and economic development and a significant medium in the tourist and entertainment industries as well as education. The need for and use of English in the workplace has had a…

  20. Concept of Best Practices in English Language Teaching to Pakistani ELT Fraternity

    ERIC Educational Resources Information Center

    Soomro, Muhammad Arif; Memon, Natasha; Memon, Shumaila Aijaz

    2016-01-01

    Teaching industry of English as a second or foreign language has grown massively in recent times in Pakistan. There are many public sectors universities and English academies established all over Pakistan offering English language proficiency courses. Therefore, this wave led to conduct this research. The purpose of conducting this study was to…

  1. Catching Up with Europe: Speakers and Functions of English in Hungary.

    ERIC Educational Resources Information Center

    Petzold, Ruth; Berns, Margie

    2000-01-01

    Discusses the functional range of English and its penetration into Hungarian society and shows that in just a few years English has become an essential tool for modernization and economic development and a significant medium in the tourist and entertainment industries as well as education. The need for and use of English in the workplace has had a…

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

    SciTech Connect

    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.

  3. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2001-01-01

    An overview of the industrial diamond industry is provided. More than 90 percent of the industrial diamond consumed in the U.S. and the rest of the world is manufactured diamond. Ireland, Japan, Russia, and the U.S. produce 75 percent of the global industrial diamond output. In 2000, the U.S. was the largest market for industrial diamond. Industrial diamond applications, prices for industrial diamonds, imports and exports of industrial diamonds, the National Defense Stockpile of industrial diamonds, and the outlook for the industrial diamond market are discussed.

  4. Is the Drug Problem Soluble?

    ERIC Educational Resources Information Center

    Jonas, Steven

    1989-01-01

    Concludes that the principle drug problems in the United States arise from the use of cigarette tobacco and alcoholic beverages. Identifies a drug culture as the persistent force in society that promotes drug use. Points out that the influence of the primary drug industries inhibit attempts to deal effectively with drug problems. (KO)

  5. Is the Drug Problem Soluble?

    ERIC Educational Resources Information Center

    Jonas, Steven

    1989-01-01

    Concludes that the principle drug problems in the United States arise from the use of cigarette tobacco and alcoholic beverages. Identifies a drug culture as the persistent force in society that promotes drug use. Points out that the influence of the primary drug industries inhibit attempts to deal effectively with drug problems. (KO)

  6. English as a Second Language. Level 2.

    ERIC Educational Resources Information Center

    Lewandowski, Carol

    This guide is intended for use in a level 2 course in English as a second language that was developed as a component of a workplace literacy program for persons employed in the manufacturing and service industries. The course is structured so that, upon its completion, students will be able to accomplish the following: ask grammatically correct…

  7. English as a Second Language. Level 1.

    ERIC Educational Resources Information Center

    Lewandowski, Carol

    This guide is intended for use in a level 1 course in English as a second language that was developed as a component of a workplace literacy program for persons employed in the manufacturing and service industries. The course is structured so that, upon its completion, students will be able to accomplish the following: ask grammatically correct…

  8. Tussle Over English-Language Learners

    ERIC Educational Resources Information Center

    Zehr, Mary Ann

    2007-01-01

    In the past decade, Harrisonburg, Virginia, has become a magnet for immigrant families drawn to jobs in the poultry and construction industries. More than 1,600 of the school district's 4,400 students are English-learners. The largest group of newcomers are Latinos, followed by Kurdish and Russian refugees. In this article, the author discusses a…

  9. Tussle Over English-Language Learners

    ERIC Educational Resources Information Center

    Zehr, Mary Ann

    2007-01-01

    In the past decade, Harrisonburg, Virginia, has become a magnet for immigrant families drawn to jobs in the poultry and construction industries. More than 1,600 of the school district's 4,400 students are English-learners. The largest group of newcomers are Latinos, followed by Kurdish and Russian refugees. In this article, the author discusses a…

  10. Risk evaluation and mitigation strategies for drugs with abuse liability: public interest, special interest, conflicts of interest, and the industry perspective.

    PubMed

    Wright, Curtis; Schnoll, Sidney; Bernstein, David

    2008-10-01

    Risk evaluation and mitigation strategies (REMS) formerly known as Risk Minimization Action Plans (RiskMAPs) are a regulatory technique for dealing with anticipated risks of new medications and are especially important for new drugs with abuse potential. This paper describes the origin and history of risk-management plans for drugs that might be abused, the proper use of these plans in minimizing the risk to the public, and the special difficulties inherent in managing risks for drugs with abuse potential. Drugs with abuse liability are distinctive since the risks inherent in manufacture and distribution include not only risks to patients prescribed the medications, but also risks to the general public including subgroups in the population not intended to get the drug and who receive no medical benefit from the medication. The crafting of risk-management plans intended to protect nonpatient populations is unique for these products. The content, extent, and level of intensity of these plans affect areas of medical ethics, civil liability, and criminal prosecution. The need for risk-management plans for drugs with abuse liability can potentially act as a deterrent to investment and is a factor in decisions concerning the development of new medications for the treatments of pain, ADHD, anxiety disorders, and addictions. This paper provides a framework for moving the process of REMS development forward and criteria for evaluating the probity and adequacy of such programs.

  11. 21 CFR 803.13 - Do I need to submit reports in English?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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,...

  12. 21 CFR 803.13 - Do I need to submit reports in English?

    Code of Federal Regulations, 2010 CFR

    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,...

  13. 21 CFR 803.13 - Do I need to submit reports in English?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Do I need to submit reports in English? 803.13... need to submit reports 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...

  14. 21 CFR 803.13 - Do I need to submit reports in English?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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,...

  15. English Language Education in Cuba.

    ERIC Educational Resources Information Center

    Irizar, Tony

    2001-01-01

    Provides an overview of English language education in Cuba. Discusses the historical role of English in Cuba, the introduction of English for specific purposes, and the current status of English instruction. (Author/VWL)

  16. English Language Teaching in Indonesia.

    ERIC Educational Resources Information Center

    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)

  17. Industrial garnet

    USGS Publications Warehouse

    Olson, D.W.

    2001-01-01

    A general overview of the industrial garnet industry is provided. About 20 percent of global industrial garnet production takes place in the U.S. During 2000, an estimated 300 kt of industrial garnets were produced worldwide. The U.S. is the world's largest consumer of industrial garnet, consuming 56.9 kt in 2000.

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

    ERIC Educational Resources Information Center

    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…

  19. A Handbook of the Job-Site English Project 1985-86.

    ERIC Educational Resources Information Center

    Acevedo, Sheila; Dovel, Frankie

    The Orange County Public Schools' Job Site English Project was initiated to provide employees of businesses and industries with work-related English for speakers of other languages. The program features individualized curricula that are developed after the curriculum writer visits the business/industry in need of services, analyzes the…

  20. An Empirical Report on an English for Special Purposes Learning Situation.

    ERIC Educational Resources Information Center

    Hickey, Joseph

    One teacher's experience in providing individualized instruction in English to a manager in the German coal mining industry is reported. The highly motivated manager required specialized skills in English for communicating with foreign visitors who were either members of the industry or lay people. The manager brought with him to the first meeting…

  1. A Handbook of the Job-Site English Project 1985-86.

    ERIC Educational Resources Information Center

    Acevedo, Sheila; Dovel, Frankie

    The Orange County Public Schools' Job Site English Project was initiated to provide employees of businesses and industries with work-related English for speakers of other languages. The program features individualized curricula that are developed after the curriculum writer visits the business/industry in need of services, analyzes the…

  2. An ecological perspective on U.S. industrial poultry production: the role of anthropogenic ecosystems on the emergence of drug-resistant bacteria from agricultural environments.

    PubMed

    Davis, Meghan F; Price, Lance B; Liu, Cindy Meng-Hsin; Silbergeld, Ellen K

    2011-06-01

    The industrialization of food animal production, specifically the widespread use of antimicrobials, not only increased pressure on microbial populations, but also changed the ecosystems in which antimicrobials and bacteria interact. In this review, we argue that industrial food animal production (IFAP) is appropriately defined as an anthropogenic ecosystem. This paper uses an ecosystem perspective to frame an examination of these changes in the context of U.S. broiler chicken production. This perspective emphasizes multiple modes by which IFAP has altered microbiomes and also suggests a means of generating hypotheses for understanding and predicting the ecological impacts of IFAP in terms of the resistome and the flow of resistance within and between microbiomes.

  3. Beginnings of the Industrial Revolution in England.

    ERIC Educational Resources Information Center

    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…

  4. English Transported: Essays on Australasian English.

    ERIC Educational Resources Information Center

    Ramson, W. S., Ed.

    This collection of essays on Australasian English deals with various aspects of the language as it is spoken in the areas of Australian, New Zealand, and Papua-New Guinea. Although the bulk of the essays are concerned with Australian and New Zealand English, the editor expresses the hope that the integrated study of these two major dialects will…

  5. English Language Teaching Profile: Spain.

    ERIC Educational Resources Information Center

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

    The role of English in Spain is discussed, with attention directed to (1) English within the educational system, (2) inspection of teachers and teaching methods, (3) commercial English, (4) adult education, (5) radio and television instruction in English, (6) English teachers, (7) English outside the educational system, and (8) British and…

  6. China's growing biomedical industry.

    PubMed

    Han, Pei

    2009-06-01

    The biomedical industry in China is developing rapidly, and new biological drugs are increasing their share of the pharmaceutical market based on people's needs. China is the largest producer and user of vaccines in the world, but the existing production of vaccines is far from enough to meet the needs of the market. The entire market of biological drugs in China is still smaller than that for traditional medicines and chemicals. Therefore, the biopharmaceutical industry has the potential to be the rising star in the pharmaceutical market in the future.

  7. English Teaching Profile: Lesotho.

    ERIC Educational Resources Information Center

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

    A profile of the role and status of the English language in Lesotho, Africa, is presented. The following topics are outlined: (1) the extent of the use of English as the second official language; (2) instruction in English at the elementary and secondary levels and at each of the postsecondary institutions in the country; (3) the number, ratio,…

  8. English Teaching Profile: Uganda.

    ERIC Educational Resources Information Center

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

    A review of the status of English language instruction in Uganda provides an overview of the role of English in society in general, and outlines the status of English use and instruction in the educational system at all levels (preprimary, elementary, secondary, higher, vocational, adult, and teacher education). The review outlines the…

  9. English Teaching in Mexico.

    ERIC Educational Resources Information Center

    Salazar, Denise

    2002-01-01

    Discusses teaching English in Mexico, a country with important social, cultural, and economic ties to the United States. Looks at the various English teaching situations as well as teacher education for teachers in Mexico. Concludes that the English teaching situation in Mexico reflects great diversity and growth, and that the knowledge of English…

  10. Business English: Curriculum Guide.

    ERIC Educational Resources Information Center

    Montag, Elizabeth J.; Shaw, Warren

    Intended as an English elective subject for senior high school students, this business English course guide provides students with the communication tools that can lead to success in the business world. Units cover the following topics: introduction to Business English (punctuation, grammar, spelling, vocabulary, and use of reference tools);…

  11. Moodling English Language Education

    ERIC Educational Resources Information Center

    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…

  12. English and the Arts.

    ERIC Educational Resources Information Center

    Mead, Russell

    1968-01-01

    English, which enrolls all students, is the only humanities course capable of transmitting culture to everyone. Students respond to cultural stimuli other than books, however; and since many justifications for traditionally narrow English courses are demonstrably not valid, English subject matter should be broadened to include methods of…

  13. English in China.

    ERIC Educational Resources Information Center

    Dzau, Y. F.; And Others

    This collection of writings on the history and status of English language teaching (ELT) in China includes the following essays: "Historical Background" (Y. F. Dzau); "How English is Taught in Tertiary Educational Institutions" (Dzau); "Teaching English in Chinese Secondary Schools" (Yu Yining); "Teachers,…

  14. Sentential Negation in English

    ERIC Educational Resources Information Center

    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…

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

    ERIC Educational Resources Information Center

    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)

  16. English in Mauritius.

    ERIC Educational Resources Information Center

    Foley, Joseph

    1995-01-01

    Provides an overview of the position of English on the island of Mauritius, where the dominant language of the home is a French-based Creole but the language of government and schooling is English. Also discusses English instruction on Mauritius, noting that language instruction on the island has been traditionally structuralist rather than…

  17. English in Vanuatu.

    ERIC Educational Resources Information Center

    Crowley, Terry

    1989-01-01

    Although English shares official language status with French in Vanuatu, enrollments in English-language schools have increased dramatically at the expense of French-medium schools. Bislama, an English-derived pidgin, has become a compromise language between the two colonial languages that have divided the country. (Author/CB)

  18. English Teaching Profile: Algeria.

    ERIC Educational Resources Information Center

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

    A survey of the status and use of the English language in Algeria is presented. The following topics are outlined: (1) the role of English as a third language, (2) its place within the educational system at all levels and in each graduate institution, (3) the status of British expatriates teaching English in Algeria and of Algerian teachers of…

  19. Moodling English Language Education

    ERIC Educational Resources Information Center

    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…

  20. English Teaching Profile: Brazil.

    ERIC Educational Resources Information Center

    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…

  1. English Teaching in Mexico.

    ERIC Educational Resources Information Center

    Salazar, Denise

    2002-01-01

    Discusses teaching English in Mexico, a country with important social, cultural, and economic ties to the United States. Looks at the various English teaching situations as well as teacher education for teachers in Mexico. Concludes that the English teaching situation in Mexico reflects great diversity and growth, and that the knowledge of English…

  2. English in China.

    ERIC Educational Resources Information Center

    Dzau, Y. F.; And Others

    This collection of writings on the history and status of English language teaching (ELT) in China includes the following essays: "Historical Background" (Y. F. Dzau); "How English is Taught in Tertiary Educational Institutions" (Dzau); "Teaching English in Chinese Secondary Schools" (Yu Yining); "Teachers,…

  3. Aboriginal English. PEN 93.

    ERIC Educational Resources Information Center

    Eades, Diana

    This report focuses on the teaching of English to Aboriginal children in primary schools in Australia. A definition and analysis of dialectal differences between Aboriginal (Australian) English and Standard (Australian) English is offered that includes the phonological, morpho-syntactic, lexico-semantic, and pragmatic differences of the Aboriginal…

  4. English Teaching Profile: Brazil.

    ERIC Educational Resources Information Center

    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…

  5. My English History.

    ERIC Educational Resources Information Center

    Sommer, Paul

    2003-01-01

    Outlines the author's history as an English teacher. Suggests that English teaching is not hermetic but profoundly influenced by educational trends outside the subject itself. Explains that the author's commitment to English combines a sense of engagement with a sense of liberation. (PM)

  6. Sentential Negation in English

    ERIC Educational Resources Information Center

    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…

  7. English Teaching Profile: Algeria.

    ERIC Educational Resources Information Center

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

    A survey of the status and use of the English language in Algeria is presented. The following topics are outlined: (1) the role of English as a third language, (2) its place within the educational system at all levels and in each graduate institution, (3) the status of British expatriates teaching English in Algeria and of Algerian teachers of…

  8. China's English Language Environment

    ERIC Educational Resources Information Center

    Gil, Jeffrey

    2008-01-01

    Chinese students and teachers often say that the major challenge they face in acquiring English is that "China does not have a good English language environment" ("zhong guo de ying yu huan jing bu tai hao") by which they mean there are insufficient opportunities to use English in real life situations and a lack of exposure to…

  9. The New English.

    ERIC Educational Resources Information Center

    Chisholm, William

    This book is an introduction to the "new" English which utilizes knowledge gained from studies and basic research to achieve practical, intelligent goals for instruction in English. The first chapter defines the new English as a study that leads students to a critical appreciation of all forms of communication, that provides them with insights…

  10. English in...Thailand

    ERIC Educational Resources Information Center

    Foley, Joseph A.

    2005-01-01

    This account of English in the formal education system in Thailand traces briefly its historical background and then looks at the teaching of English today. The country itself has quite a complex sociolinguistic context and in order to understand the teaching and learning of English, one must understand the basic tenets of the culture. From this…

  11. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2003-01-01

    Statistics on the production, consumption, cost, trade, and government stockpile of natural and synthetic industrial diamond are provided. The outlook for the industrial diamond market is also considered.

  12. How does the pharmaceutical industry influence prescription? A qualitative study of provider payment incentives and drug remunerations in hospitals in Shanghai.

    PubMed

    Yang, Wei

    2016-10-01

    Over-prescription has become one major problem in China's health care sector. Incorporating interview data from hospitals in Shanghai, this paper provided empirical evidence on how the process of over-prescription was carried out in day-to-day clinical settings, and demonstrates various mechanisms that allow over-prescription to continue vigorously in the context of the Chinese health care system. In particular, this study identified four levels of incentives that over-prescription was carried out: hospital, medical department, doctors and pharmaceutical companies. Due to the insufficient funding from the government and rising operational costs, hospitals had to rely on the sales of drugs and provision of medical services to survive. This funding pressure then transferred to specific revenue targets for medical departments. A combination of incentives, including drug remunerations, bonus system, low pay and high workloads motivated over-prescription at doctor level. At pharmaceutical company level, high profits of pharmaceuticals products as well as lack of emphasis on efficacy of drugs led to under-table payments and illicit drug remunerations. The study argued that the way that the Chinese health care system operates was based on the profit-seeking principle rather than on fulfilling its social functions, and called for a systematic reform of provider incentives to eradicating the problem of over-prescription.

  13. 78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ...; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled ``Refuse to Accept Policy for 510(k)s.'' The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a 510(k) submission is...

  14. Industry Employment

    ERIC Educational Resources Information Center

    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…

  15. Industrial Minerals

    ERIC Educational Resources Information Center

    Bradbury, James C.

    1978-01-01

    The past year is seen as not particularly good for industrial minerals and for industry in general. Environmental concerns continued to trouble the industry with unacceptable asbestos concentrations and chlorofluorocarbon effects on ozone. A halting U.S. economy also affected industrial progress. (MA)

  16. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2000-01-01

    Part of the 1999 Industrial Minerals Review. A review of the state of the global industrial diamond industry in 1999 is presented. World consumption of industrial diamond has increased annually in recent years, with an estimated 500 million carats valued between $650 million and $800 million consumed in 1999. In 1999, the U.S. was the world's largest market for industrial diamond and was also one of the world's main producers; the others were Ireland, Russia, and South Africa. Uses of industrial diamonds are discussed, and prices of natural and synthetic industrial diamond are reported.

  17. A comparison of the chemical properties of drugs and FEMA/FDA notified GRAS chemical compounds used in the food industry.

    PubMed

    Sprous, D G; Salemme, F R

    2007-08-01

    The range of molecular properties of generally recognized as safe (GRAS) compounds that are typically used in food and beverage products is compared to marketed drugs. It is observed that GRAS compounds differ from marketed drugs with respect to several molecular descriptors, including molecular weight, H-bond acceptor count, H-bond donor count, aromatic ring count, basic group count, acidic group count, molecular flexibility, enhanced ether and ester bearing compound populations, and reduced nitrogen and halogen bearing compound populations. It was observed that log(P) and log(S), which provide computed estimates of compound solubility in organic and aqueous solvents, respectively, have significant overlap in the two populations. On the whole, GRAS compounds are seen to be more flexible, smaller, and composed of a more restricted set of elements than marketed drugs. In addition, a multivariable binary quantitative structure-activity relationship (QSAR) model incorporating the parameters listed above can distinguish GRAS and pharmaceutical compounds, further strengthening the distinction between the molecular spaces defining GRAS and pharmaceutical compounds. It is speculated that the difference between the GRAS and pharmaceutical property spaces is a result of the historical legacy of most GRAS compounds, which are primarily natural in origin. Compounds more recently added to the GRAS list appear more similar to pharmaceuticals with respect to their chemical properties.

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

    PubMed Central

    Hughes, Shannon; Cohen, David; Jaggi, Rachel

    2014-01-01

    Objective 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. Design 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. Setting Clinicalstudyresults.org, sponsored by Pharmaceutical Research and Manufacturers of America; clinicaltrials.gov, administered by the US National Institutes of Health. Main outcome measure 3 coders extracted data on the numbers and types of SAEs. Results 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; p<0.001) times more likely to be published with no discrepancy in their associated journal article. Since clinicalstudyresults.org was removed from the Internet in 2011, only 7.8% of retrieved trial summaries appear with results on clinicaltrials.gov. Conclusions 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

  19. Pharma industry in India.

    PubMed

    Sundaram, V M

    2008-01-01

    Globally ranked fourth by volume and 13th in value, the Indian pharma industry is a leading producer of high-quality, low-cost generic drugs. Its 14% share of the USD 57 billion world generic market is expected to increase to 50% by 2010. With the advantages of cost competitiveness, ability and experience in reverse engineering, availability of skilled scientific and engineering personnel and the capability to produce raw materials for a wide range of drugs from the basic stage, the industry delivers the entire range of therapeutic products. McKinsey & Co. predict that India's pharmaceutical market could reach a size of USD 20 billion by 2015, becoming one of the top 10 drug markets in the world. Generic versions of the cardiovascular drug carvedilol, ANDA-approved allopurinol, verapamil SR and the anticancer drug paclitaxel are some of the recent products introduced by Indian companies, with Caraco, Ranbaxy, Dabur, Dr. Reddy's, Nicholas Piramal India, leading the list. Setting up of integrated drug development companies and aggressive entries into the Japanese drug market have provided further impetus to the country's pharma manufacturing arena.

  20. General English Ability, Specific Purpose English Ability, and Computer Skills.

    ERIC Educational Resources Information Center

    Prapphal, Kanchana

    2003-01-01

    Aims to answer the following research questions: (1) Are general English ability and specific purpose English ability related to computer skills? and (2) Is general English ability transferable to specific purpose English ability? Subjects were third year science students enrolled in an English for academic purposes course. (Author/VWL)

  1. General English Ability, Specific Purpose English Ability, and Computer Skills.

    ERIC Educational Resources Information Center

    Prapphal, Kanchana

    2003-01-01

    Aims to answer the following research questions: (1) Are general English ability and specific purpose English ability related to computer skills? and (2) Is general English ability transferable to specific purpose English ability? Subjects were third year science students enrolled in an English for academic purposes course. (Author/VWL)

  2. English as Lingua Franca and English in Europe

    ERIC Educational Resources Information Center

    Berns, Margie

    2009-01-01

    One of the objectives of English as Lingua Franca (ELF) researchers is an account of the unique features of English that they have found in the speech of European users of English. These features, it is argued, describe a variety of English which they label "English as Lingua Franca". The choice of this particular term is problematic…

  3. Food and Drug Administration

    MedlinePlus

    ... Reportable Food Registry Report an Emergency Report Suspected Criminal Activity For Industry: Drugs and Therapeutic Biologics News & ... FDA Organization FDA Basics Advisory Committees International Programs Criminal Investigations Emergency Preparedness & Response Working at FDA Training/ ...

  4. English Teaching Profile: Sierra Leone.

    ERIC Educational Resources Information Center

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

    The role and status of English in Sierra Leone are examined, with attention directed to: (1) English within the education system, (2) teachers of English, (3) materials support; (4) educational administration for English teaching, (5) development and planning, (6) British support for the teaching of English, and (7) commercial opportunities.…

  5. The Configuration of Liberia's Englishes.

    ERIC Educational Resources Information Center

    Singler, John Victor

    1997-01-01

    Discusses the varieties of Liberian English spoken in Liberia: Kru Pidgin English, spoken by Kru mariners and migrant workers; Settler English, spoken by descendants of 19th-century African American immigrants to Liberia; and Vernacular Liberian English (VLE), spoken by the rest of Liberia's English-speaking population. Focuses on tense aspect in…

  6. English Language Teaching Profile: Turkey.

    ERIC Educational Resources Information Center

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

    The role of English in Turkey is discussed, with attention directed to: (1) education within the educational system, (2) English teachers, (3) teaching materials, (4) English outside the educational system, and (5) British and American support for the teaching of English. Although English is not used as a means of social communication in Turkey,…

  7. Thanking Responders in Cameroon English

    ERIC Educational Resources Information Center

    Ouafeu, Yves Talla Sando

    2009-01-01

    An analysis of authentic or genuine interactions among Cameroon English speakers reveals that conversational routines in this variety of English differ a good deal from those obtained in other varieties of English, non-native varieties of English inclusive, and more specifically in native varieties of English. This paper looks at "thanking…

  8. Thanking Responders in Cameroon English

    ERIC Educational Resources Information Center

    Ouafeu, Yves Talla Sando

    2009-01-01

    An analysis of authentic or genuine interactions among Cameroon English speakers reveals that conversational routines in this variety of English differ a good deal from those obtained in other varieties of English, non-native varieties of English inclusive, and more specifically in native varieties of English. This paper looks at "thanking…

  9. Bilingual Education and English Proficiency

    ERIC Educational Resources Information Center

    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…

  10. English Teaching Profile (Provisional): Germany.

    ERIC Educational Resources Information Center

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

    The role and status of English instruction in West Germany is outlined. The regions of West Berlin, Hesse, and North Rhine-Westphalia are highlighted. The role of English and English instruction in the country as a whole, English instruction in the educational system, the demand for and qualifications of English teachers, textbook selection and…

  11. INTERNATIONAL ENGLISH MANUAL

    SciTech Connect

    AMADOR, MABLE; KELLER, YVONNE KELLER

    2002-02-22

    This document presents a set of guidelines for authors who wish to express themselves more clearly to foreign readers, or readers whose first language is not American English. Topics include idioms, technical terms, jargon, word meaning, acronyms, and international conventions of measurement. The guidelines will help writers of technical documents present their ideas more effectively to audiences that may include individuals whose first language is not American English, including audiences with individuals from other English-speaking countries.

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

    ERIC Educational Resources Information Center

    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…

  13. VESL for Industrial and Technical Training (VITT) Curriculum: Student Materials [and] Instructor's Guide.

    ERIC Educational Resources Information Center

    Illinois State Board of Education, Springfield. Dept. of Adult, Vocational and Technical Education.

    This student workbook and teacher's guide are for a vocational English-as-a-Second-Languge (VESL) course designed to prepare limited-English-speaking students for vocational training programs in industrial and technical fields. The curriculum focuses on the general technical English most critical in making the transition from…

  14. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2004-01-01

    Part of the 2003 industrial minerals review. Supply and demand data for industrial diamond are provided. Topics discussed are consumption, prices, imports and exports, government stockpiles, and the outlook for 2004.

  15. 76 FR 67465 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-01

    ... HUMAN SERVICES Food and Drug Administration Request for Notification From Industry Organizations... Nominations for Nonvoting Industry Representatives on Public Advisory Panels AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting that any...

  16. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2012-01-01

    Estimated 2011 world production of natural and synthetic industrial diamond was about 4.45 billion carats. During 2011, natural industrial diamonds were produced in more than 20 countries, and synthetic industrial diamond was produced in at least 13 countries. About 98 percent of the combined natural and synthetic global output was produced in China, Ireland, Japan, Russia, South Africa and the United States. China is the world's leading producer of synthetic industrial diamond followed by Russia and the United States.

  17. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2011-01-01

    Estimated world production of natural and synthetic industrial diamond was about 4.44 billion carats in 2010. Natural industrial diamond deposits have been found in more than 35 countries, and synthetic industrial diamond is produced in at least 15 countries.

  18. Industrial diamond

    USGS Publications Warehouse

    Olson, D.W.

    2006-01-01

    In 2005, estimated world production of natural and synthetic industrial diamond was 630 million carats. Natural industrial diamond deposits were found in more than 35 countries. Synthetic industrial diamond is produced in at least 15 countries. More than 81% of the combined natural and synthetic global output was produced in Ireland, Japan, Russia, South Africa and the United States.

  19. Industrial Microbiology.

    ERIC Educational Resources Information Center

    Demain, Arnold L.; Solomon, Nadine A.

    1981-01-01

    Presents an overview of the field of industrial microbiology, providing historical backgrounds of scientific discoveries in the field and descriptions of industrially important microorganisms. Applied research in industry is also detailed, with mention of gene amplification, DNA recombination, pharmaceutical approaches, and detoxification and…

  20. Industrial Microbiology.

    ERIC Educational Resources Information Center

    Demain, Arnold L.; Solomon, Nadine A.

    1981-01-01

    Presents an overview of the field of industrial microbiology, providing historical backgrounds of scientific discoveries in the field and descriptions of industrially important microorganisms. Applied research in industry is also detailed, with mention of gene amplification, DNA recombination, pharmaceutical approaches, and detoxification and…

  1. Industry Employment

    ERIC Educational Resources Information Center

    Occupational Outlook Quarterly, 2010

    2010-01-01

    This article illustrates projected employment change from an industry perspective over the 2008-2018 decade. Workers are grouped into an industry according to the type of good produced or service provided by the establishment in which they work. Industry employment projections are shown in terms of numeric change (growth or decline in the total…

  2. Do gifts from the pharmaceutical industry affect trust in physicians?

    PubMed

    Green, Michael J; Masters, Rebecca; James, Benjamin; Simmons, Bree; Lehman, Erik

    2012-05-01

    Gifts to physicians from the pharmaceutical industry are receiving increased scrutiny, but no previous research has evaluated the effect of such gifts on trust. The goal of this study is to determine patient awareness of interactions between physicians and the pharmaceutical industry and to learn whether those interactions impact trust and the doctor-patient relationship. A cross-sectional, self-administered 61-item survey was administered in five outpatient clinic waiting rooms at a US medical center in 2008. A total of 220 consecutive English-speaking adults were invited to participate. Main outcome measures included: (1) Awareness of physician relationship with the pharmaceutical industry, (2) Attitudes about physician acceptance of gifts, (3) Perceived impact of gifts on trust in physicians, and (4) Effect of gifts on intent to adhere to physician recommendations. A total of 192 individuals participated (87% response rate). While most were unaware of particular interactions between physicians and the pharmaceutical industry (12% to 60%, depending on activity), approximately half (51%) wanted to know if their physician accepted gifts >$100. A majority indicated they would have less trust in their physician if they learned he or she: accepted gifts >$100 (59%) or went on industry-sponsored trips (58%) or sporting events (54%). Further, 25% said they would be less likely to take a prescribed medication if their physician had recently accepted a gift in return for listening to a pharmaceutical representative's presentation about that drug. Accepting gifts from the pharmaceutical industry has implications for the doctor-patient relationship. Doing so can undermine trust and affect patients' intent to adhere to medical recommendations.

  3. The Importance of Foreign Language Education to the Hospitality Industry.

    ERIC Educational Resources Information Center

    Kluge, E. Alan

    In the hospitality industry there are three major needs for study of a foreign language: (1) the need to communicate with non-English speaking employees, (2) the need to assist foreign travelers; and (3) the need to work in a non-English speaking country. The strength of the need to know a foreign language depends on the employee's level within…

  4. The Importance of Foreign Language Education to the Hospitality Industry.

    ERIC Educational Resources Information Center

    Kluge, E. Alan

    In the hospitality industry there are three major needs for study of a foreign language: (1) the need to communicate with non-English speaking employees, (2) the need to assist foreign travelers; and (3) the need to work in a non-English speaking country. The strength of the need to know a foreign language depends on the employee's level within…

  5. Pharmacy-related health disparities experienced by non-english-speaking patients: impact of pharmaceutical care.

    PubMed

    Westberg, Sarah M; Sorensen, Todd D

    2005-01-01

    To identify the availability of foreign language services in pharmacies near a medical clinic serving a large immigrant population and determine whether the type of observed drug therapy problems differed between English- and non-English-speaking patients at this clinic. A community health care center in a diverse neighborhood of Minneapolis, Minnesota. 40 pharmacies near the clinic and in the surrounding Minneapolis-St. Paul area known to provide services to patients in languages in addition to English and 91 clinic patients, including 38 for whom English was not their primary language, seen for full pharmaceutical care assessments. Comprehensive drug therapy assessments were conducted for English- and non-English-speaking patients (with assistance from interpreters) in a primary care setting secondary to physician referral. Patient-specific data and the results of the pharmacist's assessment were recorded in a patient management database. Language services provided by area pharmacies, frequency of drug therapy problems in English- and non-English-speaking patients, and the status of patient's medication conditions before and after provision of pharmaceutical care. Of the six primary languages other than English (Vietnamese, Hmong, Laotian, Somali, Spanish, and Cambodian) spoken by clinic patients, written or verbal information was available for five languages in one or more area pharmacies. The clinic pharmacist completed comprehensive assessments for 91 patients via 230 patient encounters, identifying 186 drug therapy problems. Problems related to adherence were significantly more prevalent in non-English-speaking patients compared with English-speaking patients (31% versus 12%). In all 91 patients, the percentage achieving desired drug therapy outcomes improved by 24% after a pharmacist joined the team of clinic providers. Despite the availability of clinic-based interpreters and foreign language services in pharmacies, adherence-related problems are

  6. Drug discovery in jeopardy

    PubMed Central

    Cuatrecasas, Pedro

    2006-01-01

    Despite striking advances in the biomedical sciences, the flow of new drugs has slowed to a trickle, impairing therapeutic advances as well as the commercial success of drug companies. Reduced productivity in the drug industry is caused mainly by corporate policies that discourage innovation. This is compounded by various consequences of mega-mergers, the obsession for blockbuster drugs, the shift of control of research from scientists to marketers, the need for fast sales growth, and the discontinuation of development compounds for nontechnical reasons. Lessons from the past indicate that these problems can be overcome, and herein, new and improved directions for drug discovery are suggested. PMID:17080187

  7. English Teaching Profile: Mexico.

    ERIC Educational Resources Information Center

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

    A profile of the extent of English usage and instruction in Mexico gives an overview of the following elements: its role and status alongside Spanish and within the educational system at all levels; teacher education; program accreditation; required reading skills; the supply and professional support of English teachers; the type and availability…

  8. Scientific and Technical English.

    ERIC Educational Resources Information Center

    Vaclavik, Jaroslav

    Technical English differs from everyday English because of the specialized contexts in which it is used and because of the specialized interests of scientists and engineers. This text provides exercises in technical and scientific exposition in the following fields: mathematics, physics, temperature effects, mechanics, dynamics, conservation of…

  9. Questions English Teachers Ask.

    ERIC Educational Resources Information Center

    Shuman, R. Baird

    This volume is based on the responses of 374 English teachers at the secondary and college levels to a letter asking them to describe the questions that most perplex them professionally. Answers are provided by 88 leaders in English education, including James R. Squire, Walter H. MacGinitie, R. Baird Shuman, Sheila Schwartz, and Ken Macrorie. The…

  10. Towards Developmental World Englishes

    ERIC Educational Resources Information Center

    Bolton, Kingsley; Graddol, David; Meierkord, Christiane

    2011-01-01

    Over the last three decades scholars promoting the world Englishes paradigm (WE) have worked towards establishing a more positive attitude towards international varieties of English. However, despite the best intentions of Western linguists working in this field, there is an obvious imbalance between the developed and developing world in many…

  11. English in Myanmar

    ERIC Educational Resources Information Center

    Fen, Wong Soon

    2005-01-01

    This paper provides an overview of the development of English in Myanmar. It begins by tracing the changing role and status of English and Myanmar from the colonial period, which has had an impact on the current education structure. The paper outlines the structure of the education system and the recent reforms that reflect the rising importance…

  12. English for Business Communication

    ERIC Educational Resources Information Center

    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…

  13. English for Business Communication

    ERIC Educational Resources Information Center

    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…

  14. Coordinate Structures in English.

    ERIC Educational Resources Information Center

    Meyer, Charles F.

    1996-01-01

    Examines comparable speech and writing samples in the British and American components of the International Corpus of English (ICE) to study properties of coordinate structures in English. Findings indicate that "and" is a primary coordinator, that "but" and "or" are more peripheral, and that the concept of…

  15. English Loanwords in Russian.

    ERIC Educational Resources Information Center

    Benson, Morton

    1959-01-01

    This introductory survey describes the English contribution to the vocabulary of modern Russian. The author presents an analysis of English loanwords based on the etymologies of Vasmer and Lexin, by subject classification (amusements, clothing, economics, food, nautical terminology, and technology). Separate commentary on sporting terms, where…

  16. Attitudes toward Accented English.

    ERIC Educational Resources Information Center

    Ryan, Ellen Bouchard; Carranza, Miguel A.

    Among Mexican-Americans today, not only native speakers of Spanish but also many native speakers of English speak the language with a notable influence from Spanish phonology. This paper reviews a series of studies concerning reactions of Anglos and Mexican-Americans toward accented English. The unifying goal of these investigations has been the…

  17. Lexicon of Black English.

    ERIC Educational Resources Information Center

    Dillard, J. L.

    The purpose of this volume is to demonstrate that the fields of linguistics, dialectology, language education, and early reading would be well served by a word book of the Black English vernacular. Chapters are devoted to discussion of the social significance of a lexicon of Black English vernacular, the terminology of sex and lovemaking, religion…

  18. English in Indian Media.

    ERIC Educational Resources Information Center

    Khubchandani, Lachman M.

    2000-01-01

    Examines the use of English in urban India, with specific focus on the three domains of mass media, print, television, and advertising. Points to the emergence of Angrezi, which can potentially take a divergent path as an Ausbau language different from the global English. Brings under discussion interesting examples of bilingual and biscriptal…

  19. English for Global Peacekeeping

    ERIC Educational Resources Information Center

    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.

  20. Reshaping High School English.

    ERIC Educational Resources Information Center

    Pirie, Bruce

    This book takes up the question of what shape high school English studies should take in the coming years. It describes an English program that blends philosophical depth with classroom practicality. Drawing examples from commonly taught texts such as "Macbeth,""To Kill a Mockingbird," and "Lord of the Flies," the…