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Sample records for english drugs industry

  1. 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…

  2. 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.

  3. Drug information residency rotation with pharmaceutical industry.

    PubMed

    Cramer, R L

    1986-01-01

    A drug information rotation in pharmaceutical industry may be elected as a component of a hospital pharmacy residency program. Program objectives include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the pharmaceutical industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of various departments within the company. During the rotation, the resident serves as a member of the Drug Information Service. Resident activities include participating in interviews with corporate professionals, updating pharmacokinetic profiles, responding to drug information requests and participating in other information projects. This rotation enables the resident to better understand pharmaceutical industry's concerns and relate these concerns to clinical pharmacy practice. PMID:10277398

  4. 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)

  5. 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…

  6. 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…

  7. 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.

  8. 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

    ... Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug... to generic drug manufacturers to follow International Conference on Hamonisation (ICH)...

  9. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Abbreviated New Drug Applications...) guidance for industry ``Q3B(R) Impurities in New Drug Products,'' which was announced in August 2006. DATES... and Research, Food and Drug Administration, 10903 New ] Hampshire Ave., Bldg. 51, rm. 2201,...

  10. 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.

  11. 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…

  12. 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…

  13. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Compliance Policy for... guidance for industry entitled ``Compliance Policy on Reporting Drug Sample Distribution Information Under... availability of a draft guidance for industry entitled ``Compliance Policy on Reporting Drug...

  14. 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

    ... the availability of a guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and Products.'' Because of increases in the number and complexity of ANDAs and FDA's desire to standardize... new drug applications to ensure the stability of new drug substances and products, FDA believes......

  15. The industrial challenge in reproductive drug development.

    PubMed

    Southern, E M

    1978-01-01

    An enormous expenditure of time, research, and money is required to develop and market a new contraceptive in the U.S. In addition to the investigation of new scientific knowledge, the intricacy of government regulations, which are stricter for contraceptives than for most other drugs, adds to the complexity of the research process. Testing procedures are lengthy, beginning with tests on laboratory animals, and before a new contraceptive drug proven effective in animals can be tested on humans, a series of animal toxicology tests must be performed. Human clinical trials are also prolonged and complex; some 10-15 years may elapse between the discovery of a suitable contraceptive compound and final approval to market a useful product. The history of Depo-Provera illustrates some of the scientific and regulatory difficulties involved in bringing a new contraceptive to market. Because of rejection by Food and Drug Administration, despite recommendations by experts, the impact of this important new contraceptive method involving years of research has been severely curtailed. Research on prostaglandins is another contribution to the development of effective fertility control methods. Were this research to lead to the development of a safe, fully effective, self-administered agent for menstrual regulation available worldwide at a low cost, the impact on fertility could be highly significant. Overriding factors are availability of research funds and approval for marketing. Access to new, improved contraceptives will depend upon decisions by government policy-makers which effect research priorities and drug regulatory procedures.

  16. 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.

  17. 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

    ... Arrangements for Drugs: Quality Agreements; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality Agreements.'' This... drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality,...

  18. 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…

  19. 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

    ... guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This... Systems.'' This draft guidance provides recommendations to developers and manufacturers of TDDS, TMDS, and... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Drug in...

  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. PMID:3576584

  2. [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.

  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

    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. 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

  6. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Rheumatoid Arthritis... guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.''...

  7. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  8. 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.

  9. 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…

  10. 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. PMID:23543602

  11. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Pulmonary Tuberculosis... industry entitled ``Pulmonary Tuberculosis: Developing Drugs for Treatment.'' The purpose of the draft... tuberculosis. This guidance applies to the development of a single investigational drug as well as...

  12. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... ``Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling.'' FDA is issuing this guidance with labeling recommendations because of concerns that both healthcare providers and patients...

  13. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications; 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 the availability of the guidance...

  14. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  15. 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...

  16. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration..., Including Certain First in Human Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  17. 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 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 draft guidance for...

  18. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Investigational New Drug 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...

  19. 77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... HUMAN SERVICES Food and Drug Administration Guidances for Industry and Food and Drug Administration... Approval and Premarket Notification (510(k)) Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  20. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Electronic Healthcare Data Sets; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic...

  1. 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)...

  2. 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

    ... Bioequivalence Data for Abbreviated New Drug Applications; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications.'' The guidance is intended to assist abbreviated new drug application (ANDA) applicants...

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

    PubMed

    Korth-Bradley, J M

    2016-07-01

    As part of drug development, drug companies conduct experiments to gather data about the potential toxicity of medications in pregnant and lactating animals. Increasingly, physiologically based pharmacokinetic models are developed to simulate drug concentrations in pregnant and lactating women. As these women are not usually included in clinical trials, targeted postapproval safety monitoring, registries, or clinical studies may be performed to gather safety and efficacy information about drug use in these special populations. PMID:27082822

  4. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of...

  5. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Availability AGENCY: Food and Drug Administration,...

  6. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Qualification Process for... entitled ``Qualification Process for Drug Development Tools.'' This draft guidance describes the qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple...

  7. 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.

  8. Job-Related Language Training for Limited English Proficient Employees: A Handbook for Program Developers and A Guide for Decision Makers in Business and Industry.

    ERIC Educational Resources Information Center

    Thomas, Robert J.; And Others

    This two-part manual is designed to assist employers who desire to retain, promote, or retrain their limited-English-proficient (LEP) workforce to meet the challenge of training and adaptation to job restructuring. This document contains manuals for both English-as-a-Second-Language (ESL) program developers and business/industry decision makers.…

  9. 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... availability of a draft guidance for industry 211 entitled ``Residual Solvents in Animal ] Drug...

  10. 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

  11. 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…

  12. 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

    ... Staff: The Content of Investigational Device Exemption and Premarket Approval Applications for Low... document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of... Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA)...

  13. 78 FR 28228 - Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Healthcare Data; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA...

  14. 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

    ... Affecting the Hematopoietic System.'' That draft guidance, when finalized, is intended to supersede the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Investigational... Hematopoietic System; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  15. 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...

  16. 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

    ... on February 10, 2004 (69 FR 6309). DATES: Submit either electronic or written comments on Agency... Federal Register of January 23, 2002 (67 FR 3060), FDA published a final rule that amended the OTC drug... HUMAN SERVICES Food and Drug Administration (Formerly 2004D-0027) Guidance for Industry on Time...

  17. 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

    ... food-producing animals. It does not create or confer any rights for or on any person and does not... of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration...-Producing Animals.'' The draft guidance, when finalized, is intended to provide guidance to industry...

  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

    ... Federal Register of June 1, 2006 (71 FR 31194), FDA published the notice of withdrawal and revision of... Substance Chemistry, Manufacturing, and Controls Information; Availability AGENCY: Food and Drug... availability of a guidance for industry 169 entitled ``Drug Substance Chemistry, Manufacturing, and...

  19. 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.

  20. 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;…

  1. English Teaching Profile: Turkey.

    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 Turkey 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, characteristics, and training of teachers of English; the…

  2. The drug industry and clinical research in interwar America: three types of physician collaborator.

    PubMed

    Rasmussen, Nicolas

    2005-01-01

    This essay describes collaborations between American pharmaceutical companies and clinical investigators, mainly in academic medical centers and other research institutions, during the interwar period. I argue that efforts on the part of early twentieth-century "scientific medicine" reformers to impose higher standards on the testing and promotion of pharmaceuticals led both to the intended disciplining of the drug industry and also, as a reciprocal but unintended consequence, to a deep involvement with industry among medical scientists. Three basic patterns of collaboration between clinical trialists and sponsoring drugs firms are described. These patterns may help illuminate the mutual accommodation between ethical drug firms and academic clinical researchers (and institutions) that still prevails today.

  3. 76 FR 48870 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... 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..., Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD...

  4. 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)...

  5. 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

    ... in part 312 (21 CFR Part 312). In the Federal Register of October 20, 2009 (74 FR 53751), FDA...: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord... Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord...

  6. 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.

  7. 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...

  8. 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)…

  9. 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 the…

  10. 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.

  11. 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…

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

    PubMed

    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. PMID:3881052

  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. [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.

  15. 76 FR 44594 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems... Document: Repetitive Transcranial Magnetic Stimulation Systems.'' This guidance document describes a...

  16. 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...

  17. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  18. 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

    ... 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... Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and...

  19. 78 FR 35940 - Guidance for Industry on Codevelopment of Two or More New Investigational Drugs for Use in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... drugs that are intended to be used in combination to treat a disease or condition. A sponsor may elect... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Codevelopment of Two or More New Investigational Drugs for Use in Combination; Availability AGENCY: Food and Drug Administration, HHS....

  20. 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 Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  1. 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...

  2. 77 FR 72869 - Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Limiting the Use of Certain...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,...

  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

    ... Supplements for Manufacturing Method or Process Changes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration...

  4. 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...

  5. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  6. 77 FR 69634 - Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of guidance...

  7. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  8. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of...

  9. On the industrial applications of MCRs: molecular diversity in drug discovery and generic drug synthesis.

    PubMed

    Kalinski, Cédric; Umkehrer, Michael; Weber, Lutz; Kolb, Jürgen; Burdack, Christoph; Ross, Günther

    2010-08-01

    During the last decades, multicomponent chemistry has gained much attention in pharmaceutical research, especially in the context of lead finding and optimization. Here, in particular, the main advantages of multicomponent reactions (MCRs) like ease of automation and high diversity generation were utilized. In consequence of these beneficial properties, a plethora of new MCRs combined with appropriate classical reaction sequences have been published, the accessible chemical space was extended steadily. In the meantime, the desired high diversity became a challenge itself, because by now the systematic use of this huge and unmanageable space for drug discovery was limited by the lack of suitable computational tools. Therefore, this article provides an insight for the rational use of this enormous chemical space in drug discovery and generic drug synthesis. In this context, a short overview of the applied chemo informatics, necessary for the virtual screening of the biggest available chemical space, is given. Furthermore, some examples for recently developed multicomponent sequences are presented.

  10. 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.

  11. 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…

  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

    ... 1995 This guidance refers to previously approved collections of information found in FDA regulations...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... access to the guidance document. Submit electronic comments on the guidance to...

  13. Four lessons from global health drug discovery: medicine for an ailing industry?

    PubMed

    Elliott, Richard L

    2012-09-13

    In recent years, the pharmaceutical industry has faced many challenges to its business model, undergoing tremendous change and turmoil to survive. Are there any lessons to be drawn from drug discovery focused on Global Health, where there is little market incentive?

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... (74 FR 46433), FDA announced the availability of the draft guidance. Comments on the draft guidance... Differentiation of Human Papillomaviruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Differentiation of Human Papillomaviruses.'' This guidance document provides industry and Agency staff...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-04

    ... regulation to the regulated industry. Date and Time: The public workshop will be held on June 20 and 21, 2011.... Seats are limited; therefore, please submit your registration as soon as possible. Course space will be... possible on a space available basis on the day of the public workshop beginning at 7:30 a.m. The cost...

  16. 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.

  17. 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. PMID:27341432

  18. 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…

  19. 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.

  20. 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

    ... guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a... 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...

  1. Minimum Teaching Essentials: Grades 5-9. Special Subjects. English as a Second Language, Foreign Language, Home Economics, Industrial Arts, Library Media, Typewriting.

    ERIC Educational Resources Information Center

    New York City Board of Education, Brooklyn, NY. Div. of Curriculum and Instruction.

    This guide presents the "minimum teaching essentials" published by the New York City Board of Education for grades 5-9. Subjects covered include: (1) communication arts; (2) English as a second language; (3) foreign language; (4) home economics; (5) industrial arts; (6) library skills; and (7) typewriting. Study skills for these areas are given…

  2. 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

    ...) System for Drug Establishment Registration.'' This draft guidance specifies the UFI system for... guidance specifies the UFI system as follows. At this time, FDA's preferred UFI for a drug establishment is... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Specification of the...

  3. 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... to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related... ANDAs and PASs to ANDAs for which the applicant is seeking approval of a new strength of the...

  4. 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

    ... Important Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration... a guidance for industry (GFI 209) entitled ``The Judicious Use of Medically Important Antimicrobial... thinking on the use of medically important antimicrobial drugs in animal agriculture. DATES: Submit...

  5. 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.

  6. 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…

  7. 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. PMID:26890488

  8. 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.

  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.

  10. 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

    ... Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement... availability of draft guidance for industry and FDA staff entitled ``Glass Syringes for Delivering Drug and... glass syringes that comply with the ISO 11040-4 standard when connected to devices (``connecting...

  11. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Heparin for Drug and Medical Device... confirm the species origin of crude heparin in each lot of every shipment before use in the manufacture or... testing crude heparin and for the identification of species origin. The method should be based on...

  12. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Administration (FDA) is correcting a notice that appeared in the Federal Register of April 25, 2011 (76 FR...

  13. 78 FR 70953 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ...The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability entitled ``Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)'', published in the Federal Register of September 10, 2013 (78 FR 55261). In that notice, FDA requested public comment on the draft guidance. FDA is reopening the comment......

  14. 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

    ... classification information.'' In the Federal Register of April 29, 2010 (75 FR 22601), FDA announced the...; 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...

  15. 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

    ....'' Because of the public health implications of both epidemic and pandemic influenza, the variable nature of... effects under epidemic and pandemic conditions. A draft notice of availability of this guidance was... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Influenza: Developing Drugs...

  16. 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...

  17. 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…

  18. 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…

  19. 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…

  20. 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

    ... Drug Research Committee: Human Research Without an Investigational New Drug Application; Availability... Drug Research Committee: Human Research Without an Investigational New Drug Application.'' This... committee, or ] whether research studies must be conducted under an investigational new drug...

  1. 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

    ... Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice...) Requests for Information Under the Federal Food, Drug, and Cosmetic Act.'' This draft guidance is not final...) Requests for Information Under the Federal Food, Drug, and Cosmetic Act'' to the Division of...

  2. 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.

  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. 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

    ..., 2010 (75 FR 22599), FDA announced the availability of the draft guidance. Comments on the draft... 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.''...

  5. 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... and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water...

  6. 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...

  7. 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. PMID:26181187

  8. 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

    ... Investigational Drugs Under an Investigational New Drug Application--Questions and Answers; Availability AGENCY... under an investigational new drug (IND) application. FDA has received a number of questions about how it... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51,...

  9. 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. PMID:27052879

  10. 78 FR 24425 - Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-25

    ... studies on an old system. The draft of this guidance was issued on January 5, 2009 (74 FR 302). The... guidance is also applicable for some 510(k) cleared devices for which transition to a new system presents...; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and...

  11. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of... notice that appeared in the Federal Register of Monday, August 27, 2012 (77 FR 51811). The...

  12. 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...

  13. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ... efficiency of the review process. This draft guidance is not final nor is it in effect at this time. DATES... review process between FDA and industry for specific medical device premarket submissions. Further... recommendations for MDUFA III, Title II of the Food and Drug Administration Safety and Innovation Act, Public...

  14. [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

  15. [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

  16. 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...

  17. 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

    ... Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Availability AGENCY: Food... applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs... Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002....

  18. 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... ``Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug... intended to assist human drug compounders that choose to register as outsourcing facilities...

  19. 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…

  20. 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

    ... quantitate the anti-seizure drugs lamotrigine and zonisamide in serum. The Therapeutic Drug Monitoring (TDM... TDM Roundtable recommendations. Some of the general concepts in this guidance may also be helpful...

  1. 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

    ... central nervous system, drugs that are chemically or pharmacologically similar to other drugs with known... Abuse (NIDA), as described in a Memorandum of Understanding (MOU) of March 8, 1985 (50 FR 9518). When...

  2. 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

    ... compendial drug products will be based on the active moiety. The name and strength of the active ingredient... monograph title, and the strength will be expressed in terms of the active moiety. The policy allows for... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH...

  3. 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; Use of ``Light,'' ``Mild,'' ``Low,'' or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  4. 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... entitled ``Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B... register as outsourcing facilities (outsourcing facilities). DATES: Although you can comment on...

  5. 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

    ... Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief; Draft Guidance for Industry and FDA... for Pain Relief Intended for Over the Counter Use; Draft Guidance for Industry and FDA Staff''; (5... Output for Pain Relief; Draft Guidance for Industry and FDA Staff''; (6) ``Class II Special...

  6. The role of population pharmacokinetics in drug development in light of the Food and Drug Administration's 'Guidance for Industry: population pharmacokinetics'.

    PubMed

    Williams, P J; Ette, E I

    2000-12-01

    Population pharmacokinetics (PPK) has evolved from a discipline primarily applied to therapeutic drug monitoring to one that plays a significant role in clinical pharmacology in general and drug development in particular. In February 1999 the US Food and Drug Administration issued a 'Guidance for Industry: Population Pharmacokinetics' that sets out the mechanisms and philosophy of PPK and outlines its role in drug development. The application of PPK to the drug development process plays an important role in the efficient development of safe and effective drugs. PPK knowledge is essential for mapping the response surface, explaining subgroup differences, developing and evaluating competing dose administration strategies, and as an aid in designing future studies. The mapping of the response surface is done to maximise the benefit-risk ratio, so that the impact of the input profile and dose magnitude on beneficial and harmful pharmacological effects can be understood and applied to individual patients. PPK combined with simulation methods provides a tool for estimating the expected range of concentrations from competing dose administration strategies. Once extracted, this knowledge can be applied to labelling or used to assess various future study designs. PPK should be implemented across all phases of drug development. For preclinical studies, PPK can be applied to allometric scaling and toxicokinetic analyses, and is useful for determining 'first time in man' doses and explaining toxicological results. Phase I studies provide initial understanding of the structural model and the effect of possible covariates, and may later be used to evaluate PPK differences between patients and healthy individuals. Phase II studies provide the greatest opportunity to map the response surface. With these PPK models it is possible to gain an improved understanding of the role of the dose on the response surface and of the range of expected responses. In phase III and IV studies, PPK

  7. 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

  8. 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. PMID:22698049

  9. 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

  10. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring... and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2312... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH...

  11. 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

    ... Federal Food, Drug, and Cosmetic Act (the FD&C Act), procedural information on how to fulfill section 522... INFORMATION: I. Background Postmarket surveillance under section 522 of the FD&C Act (21 U.S.C. 306l) is one... Food and Drug Administration Amendments Act of 2007 amended section 522 of the FD&C ] Act to expand...

  12. 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

  13. Black English in the Integrated Workplace.

    ERIC Educational Resources Information Center

    Botan, Carl; Smitherman, Geneva

    1991-01-01

    This study of lexical familiarity with black English for 324 African Americans, 266 whites, 21 Latino and "other", and 10 unidentified workers indicates that white industrial workers are more familiar with black English than are white white-collar workers. Black English is the core of an industrial lingua franca. (SLD)

  14. 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.

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

    PubMed

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

    2016-10-01

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

  16. 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

    ... current thinking regarding the overall development program and clinical trial designs for drugs to support... Administration Safety and Innovation Act that FDA review guidances for the conduct of clinical trials...

  17. 76 FR 569 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ... for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus and Staphylococcus aureus; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The... Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and...

  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

    ... Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration... of the draft guidance entitled ``Medical Device Classification Product Codes.'' The purpose of the... classification product codes for medical devices regulated by the Center for Devices and Radiological...

  19. 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

  20. 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.

  1. 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.…

  2. 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. PMID:19520877

  3. Preclinical drug metabolism in the age of high-throughput screening: an industrial perspective.

    PubMed

    Rodrigues, A D

    1997-11-01

    With the advent of genomics, combinatorial paradigms and high-throughput screen (HTS)-based pharmacological testing, the number of compounds flowing through the discovery pipeline is likely to escalate. At the same time, with increased knowledge of the human drug-metabolizing enzymes and the availability of in vitro absorption-metabolism (AM) models, Preclinical Drug Metabolism is poised to meet the challenges of HTS. In order to be successful, however, a rational HTS strategy (vs. serendipitous HTS) has to be employed. Such a strategy is based on automation, validation and integration of in vitro AM models and database management (AVID). A generalized strategy for rational (AVID-based) HTS in Preclinical Drug Metabolism is described briefly.

  4. 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.

  5. 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

  6. 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.

  7. 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

    ... same title was announced in the Federal Register on March 13, 2008 (73 FR 13546), and Docket No. FDA... includes only the information that these drugs are indicated to reduce blood pressure; the labeling does... blood pressure reduction. However, blood pressure control is well established as beneficial...

  8. 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

    ... clinical trial designs to support approval of drugs. DATES: Although you can comment on any guidance at any... previously conducted clinical trials with various effective antibiotics. The draft guidance also provides a... of information referred to in the guidance for clinical trial sponsors ``Establishment and...

  9. 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

    ... clinical trial designs to support approval of drugs. DATES: Although you can comment on any guidance at any... trial sponsors ``Establishment and Operation of Clinical Trial Data Monitoring Committees'' have been... margin based on historical observational data compared to the results of previously conducted...

  10. 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... Staphylococcus Aureus (MRSA) for Culture-Based Devices'' to the Division of Small Manufacturers,...

  11. 78 FR 27115 - Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... (21 CFR part 312, subpart I) went into effect on October 13, 2009 (74 FR 40900). These regulations... implementation of its expanded access regulations. Therefore, FDA is providing this draft guidance in a question... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring,...

  12. 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,...

  13. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... Helicobacter pylori; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... detecting Helicobacter pylori (H. pylori). This draft guidance is not final nor is it in effect at this time... Detection of Antibodies to Helicobacter pylori,'' to suggest information that submitters provide that...

  14. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug... availability of the draft guidance entitled ``Design Considerations for Devices Intended for Home Use.'' This document is intended to assist manufacturers in designing and developing home use medical devices...

  15. 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

    ..., including CTR, CTT, and Low Glucose Suspend systems. On June 22, 2011 (76 FR 36542), FDA announced the... Staff; the Content of Investigational Device Exemption and Premarket Approval Applications for... document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational...

  16. 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...

  17. 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...

  18. Binding Free Energy Calculations for Lead Optimization: Assessment of Their Accuracy in an Industrial Drug Design Context.

    PubMed

    Homeyer, Nadine; Stoll, Friederike; Hillisch, Alexander; Gohlke, Holger

    2014-08-12

    Correctly ranking compounds according to their computed relative binding affinities will be of great value for decision making in the lead optimization phase of industrial drug discovery. However, the performance of existing computationally demanding binding free energy calculation methods in this context is largely unknown. We analyzed the performance of the molecular mechanics continuum solvent, the linear interaction energy (LIE), and the thermodynamic integration (TI) approach for three sets of compounds from industrial lead optimization projects. The data sets pose challenges typical for this early stage of drug discovery. None of the methods was sufficiently predictive when applied out of the box without considering these challenges. Detailed investigations of failures revealed critical points that are essential for good binding free energy predictions. When data set-specific features were considered accordingly, predictions valuable for lead optimization could be obtained for all approaches but LIE. Our findings lead to clear recommendations for when to use which of the above approaches. Our findings also stress the important role of expert knowledge in this process, not least for estimating the accuracy of prediction results by TI, using indicators such as the size and chemical structure of exchanged groups and the statistical error in the predictions. Such knowledge will be invaluable when it comes to the question which of the TI results can be trusted for decision making.

  19. 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.

  20. 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. PMID:26122569

  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. 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

  3. Results of a survey of biological drug and device industries inspected by FDA under the Team Biologics Program.

    PubMed

    Buchholz, Steve; Gangi, Victor J; Johnson, Anne; Little, Jacqueline; Mendivil, Steven; Trott, Carolyn; Webber, Keith; Weinstein, Mark

    2007-01-01

    The Product Quality Research Institute, in conjunction with the Food and Drug Administration, conducted an anonymous, electronic survey of the biological products manufacturing industry inspected by Team Biologics, with emphasis in obtaining industry input on inspection and compliance aspects of program operations. Representatives from all of the product-specific manufacturing industries inspected under the Team Biologics Program responded to this survey (vaccines; fractionated plasma proteins and recombinant analogs; allergenics; therapeutics and in-vivo diagnostics; and in-vitro diagnostics, including blood grouping reagents). Data and written feedback was obtained regarding each firm's interactions and experiences of Team Biologics inspections at its facilities over the past three years. The three areas most impacted by Team Biologic inspections were "Production and Process Controls", "Failure Investigations" and "Facility / Equipment Controls". Overall assessment of the program was generally positive with 68% identifying a positive impact on the sites operations and 88% assessed the inspections as being conducted fairly. The findings and conclusions of this report will be utilized by the FDA to evaluate and further assess the impact of the Team Biologics Program and to implement any necessary changes. This report provides useful information to companies currently manufacturing licensed biologic products subject to Team Biologics inspections and also to those companies anticipating these inspections for future product manufacturing.

  4. 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. PMID:22386071

  5. 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

  6. 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

    ... Federal Register of September 12, 2006 (71 FR 53696), FDA announced the availability of a draft guidance... in vivo studies of drug metabolism, drug transport, and drug-drug, or drug-therapeutic protein... metabolism and/or drug transport abruptly in individuals who previously had been receiving and tolerating...

  7. [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.

  8. Perceived and self-reported licit and illicit drug use among fishing industry workers on the mid-north coast of Western Australia.

    PubMed

    Carruthers, Susan; Boots, Kevin; Midford, Richard

    2002-12-01

    This paper describes the perceptions of boat owners and regional health workers about the use of alcohol and illicit substances within the West Australian mid-west coast fishing industry. It also reports on a survey conducted among fishing industry workers concerning their consumption of alcohol and illicit drugs while at sea and in port. Boat owners and health workers perceived that cannabis and alcohol were the most commonly used substances, a perception borne out by the results of the survey. While the levels of illicit drug use for this group were lower than those reported in the fishing industry in an eastern Australian state (Queensland), they were nevertheless considerably higher than those recorded for the general population aged up to 35 years in a National Drug Survey. Cannabis was indeed the most frequently used illicit drug and injecting drug use was minimal. Alcohol use was particularly high and binge drinking described frequently. The results are compared with other industry findings and discussed in terms of occupational health and safety. Recommendations are suggested for future prevention programmes.

  9. 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,…

  10. 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…

  11. 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)

  12. 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. PMID:23138892

  13. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ...; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration...) of the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C...

  14. 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)…

  15. 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…

  16. 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…

  17. 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

    ... Staff; Center for Devices and Radiological Health Appeals Processes; Availability AGENCY: Food and Drug... and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, rm. 4613.... Buckles, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire...

  18. 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...

  19. 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

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 10, 2010 (75 FR 32952), FDA announced... 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...

  20. 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

    ... with which they are included. In the Federal Register of November 5, 2009 (74 FR 57319), FDA announced... Ingested OTC Liquid Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products.'' This document...

  1. English Grammaticology

    ERIC Educational Resources Information Center

    Leitner, Gethard

    1985-01-01

    Discusses the historical evolution of four types of grammars in the English language as well as some causes of the problems people experience in using modern grammars of English. Contends that grammars are a "text type" that rests on quite specific text structural principles and on several textual levels. (SED)

  2. 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,…

  3. 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.

  4. 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

  5. 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.

  6. 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

  7. 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

    ... in the Federal Register of May 31, 2012 (77 FR 32124). The document announced the availability of a... INFORMATION: In FR Doc. 2012-13143, appearing on page 32124 in the Federal Register of Thursday, May 31, 2012... Evaluation of Drugs for Treatment; Availability; Correction AGENCY: Food and Drug Administration, HHS....

  8. 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.

  9. 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.

  10. 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... availability of the draft guidance entitled ``Implanted Blood Access Devices for Hemodialysis.'' This guidance was developed to support the reclassification of the Implanted Blood Access Devices for...

  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.

  12. 75 FR 53971 - Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ...; Impact-Resistant Lenses: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Impact-Resistant Lenses: Questions and Answers.'' This guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including questions on...

  13. 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

    ... clarification on related issues such as user fee exemptions for orphan drugs. In the Federal Register of March 14, 2011 (76 FR 13629), FDA announced the availability of a revised draft guidance entitled...

  14. 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. PMID:26886317

  15. 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…

  16. 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

  17. 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

  18. 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.

  19. 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. PMID:21346508

  20. English in the Garment Shops.

    ERIC Educational Resources Information Center

    Verplaetse, Lorrie

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

  1. 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.

  2. 75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... Pressure Wound Therapy; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... Pressure Wound Therapy (NPWT).'' This guidance document describes a means by which non-powered suction... Device Intended for Negative Pressure Wound Therapy (NPWT)'' to the Division of Small...

  3. 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

    ... 3, 2007 (72 FR 137). The comment period closed on April 2, 2007. Over 25 companies, numerous... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 2006D-0504) Radio Frequency Wireless...) is announcing the availability of the guidance entitled ``Radio Frequency Wireless Technology...

  4. 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

    ... for the Topical Approximation of Skin; Availability AGENCY: Food and Drug Administration, HHS. ACTION... Intended for the Topical Approximation of Skin.'' This guidance document describes a means by which tissue adhesives with adjunct wound closure devices intended for the topical approximation of skin may comply...

  5. 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

    ..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-796-6380; or Stephen Ripley... specific questions during product development and early protocol ] planning, about device studies...

  6. 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

    ... Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for... entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for...

  7. 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...

  8. 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

    ... notification from manufacturers has a significant impact on the incidence and duration of shortages. Manufacturers can play a critical role in decreasing the impact of shortages by reporting to the FDA... (IFR) on drug shortages published in the Federal Register of December 19, 2011 (76 FR 78530),...

  9. 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

    ... specifically address children's toy laser products. FDA recently issued a proposed rule (78 FR 37723) that... HUMAN SERVICES Food and Drug Administration Minimizing Risk for Children's Toy Laser Products; Draft... availability of the draft guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This...

  10. 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...

  11. ''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…

  12. 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…

  13. 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…

  14. 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.…

  15. 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…

  16. 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.

  17. 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

    ... Tobacco to Protect Children and Adolescents'' (75 FR 13225, March 19, 2010, codified at 21 CFR part 1140... 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...

  18. English Instruction in English-Language Colleges.

    ERIC Educational Resources Information Center

    Conseil des Colleges, Quebec (Quebec).

    Developed to promote the consistency and quality of English instruction and to support the English-language colleges of Quebec in this direction, the report presents an overview of English instruction at the college level and presents recommendations to the Minister of Higher Education and Science (MHES) and the English-language colleges. Part I…

  19. 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.

  20. 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. PMID:22950510

  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. 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 "ENGLISH AND THE…

  3. 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…

  4. English in Australia.

    ERIC Educational Resources Information Center

    Jernudd, Bjorn H.

    This paper provides a review of "English Transported: Essays on Australasian English," edited by W. S. Ramson. The book is a collection of articles on the various types of English spoken mainly in Australia and New Zealand. Articles discuss such varieties as nineteenth and twentieth century Australian English, New Zealand English, Pidgin English…

  5. English Teaching Profile: Cameroon.

    ERIC Educational Resources Information Center

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

    A description of the role and status of the English language in Cameroon begins with an overview of the distribution of English speakers and the common uses of English. Subsequent sections outline (1) the use and status of English within the educational system at all levels, including teacher education; (2) the availability of English language…

  6. English Teaching Profile: Iraq.

    ERIC Educational Resources Information Center

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

    A description of the role and status of the English language in Iraq begins with an overview of the distribution of English speakers and the most common uses of English. Subsequent sections outline: (1) the use and status of English within the educational system at all levels, including teacher education; (2) the availability of English language…

  7. 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.

  8. Reduction in the estrogenic activity of a treated sewage effluent discharge to an English river as a result of a decrease in the concentration of industrially derived surfactants.

    PubMed

    Sheahan, David A; Brighty, Geoff C; Daniel, Mic; Jobling, Susan; Harries, Jule E; Hurst, Mark R; Kennedy, Joe; Kirby, Sonia J; Morris, Steven; Routledge, Edwin J; Sumpter, John P; Waldock, Michael J

    2002-03-01

    As a result of the introduction of tighter discharge limits and effluent treatment processes at source, the concentration of alkylphenol ethoxylates and nonylphenol present in the final effluent discharge from a sewage treatment works that treats trade effluent from the textiles industry was reduced. The estrogenic effects of the final effluent discharge to the Aire River were compared over a four-year period during which various treatment measures were introduced. Male rainbow trout exposed to the effluent on four occasions in consecutive years (1994-1997) showed a reduction in the level of induced vitellogenesis between 1994 and 1997. A marked decrease in gonadosomatic index (GSI) and increase in heptaosomatic index (HSI) was measured in fish exposed to the effluent in 1994. In successive years, these differences diminished, and in the case of the GSI no measurable difference was observed between fish exposed to the final effluent or those in the control group in 1997. However, an increase in HSI was still measurable in 1997 in fish exposed to the final effluent and at sites farther downstream. The reduction in the effects of the effluent paralleled the reduction in the concentration of nonylphenol as well as its mono- and diethoxylates, which have been demonstrated to produce estrogenic effects in trout exposed to these compounds in the laboratory. This study demonstrates that the setting of more restricted discharge limits for known estrogenic chemicals of industrial origin can lead to significant reductions in the estrogenic activity of the watercourses into which the effluents are discharged. PMID:11878464

  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. 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

  11. English Teaching Profile: Korea.

    ERIC Educational Resources Information Center

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

    The role and status of English instruction in Korea is outlined. The role of English in Korea as a whole, English instruction within the educational system, language teacher training, textbook use, educational administration, educational development and planning, English instruction outside of the educational system, British and American support…

  12. 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…

  13. 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…

  14. 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)

  15. 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…

  16. English Teaching Profile: Poland.

    ERIC Educational Resources Information Center

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

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

  17. An Effective English Program for the Technical School.

    ERIC Educational Resources Information Center

    Erickson, Harold P.

    On the basis of responses from (1) 133 of 379 industries in Wisconsin, Iowa, and Minnesota to which questionnaires were distributed, (2) 14 interviews with technicians in Wisconsin and Minnesota, and (3) seven technical schools which submitted copies of their 2-semester English programs, the author correlated a recommended English program with the…

  18. 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,...

  19. 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,...

  20. 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...

  1. 21 CFR 803.13 - Do I need to submit reports in English?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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,...

  2. 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,...

  3. 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.

  4. 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)

  5. 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…

  6. Teaching English in Indonesia

    ERIC Educational Resources Information Center

    Tarigan, T. E.

    1975-01-01

    Gives a brief survey of the background and place of English in the Indonesian secondary school system and discusses students' English proficiency level in relation to factors that impede effective teaching. (RM)

  7. Navajo-English Dictionary.

    ERIC Educational Resources Information Center

    Wall, Leon; Morgan, William

    A brief summary of the sound system of the Navajo language introduces this Navajo-English dictionary. Diacritical markings and an English definition are given for each Navajo word. Words are listed alphabetically by Navajo sound. (VM)

  8. Some Observations on Navajo English.

    ERIC Educational Resources Information Center

    Bartelt, H. Guillermo

    1981-01-01

    Aspects of Navajo English are examined to illustrate how Native American English differs from standard English of native speakers. Phonological, morphological, and syntactic characteristics of Navajo English are noted. Navajo English also differs from standard English in its approach to time frameworks and tenses. It is suggested that much of the…

  9. English Clubs: Introducing English to Young Learners

    ERIC Educational Resources Information Center

    Afia, Jawida Ben

    2006-01-01

    This article introduces an approach taken in Tunisia to introduce English as a foreign language to children in primary school classrooms. The author states that in Tunisia, children in primary schools are first taught Arabic and then French. The government does not want to overburden the students with English learning. Then, the author describes…

  10. 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…

  11. 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)

  12. 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…

  13. Competencies in Teaching English.

    ERIC Educational Resources Information Center

    Purves, Alan C.

    This paper discusses suggested requirements for a competency-based English teacher training program on the high school or college level. The author argues that an English teacher needs to demonstrate a basic knowledge of the subject matter in three areas: the structure and history of the English language, rhetorical theory and practice, and…

  14. English for Diplomats.

    ERIC Educational Resources Information Center

    Noss, Richard B.

    A course in English as a second language for diplomats, offered in Washington, D.C. is described. The course consists of two levels: the first aims at non-native speakers of English with threshold proficiency, and the second is designed for current and prospective personnel in foreign diplomatic services of non-English-speaking countries. The…

  15. 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…

  16. 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)

  17. Papers on Irish English.

    ERIC Educational Resources Information Center

    O Baoill, Donall P., Ed.

    Six papers on Irish English are presented. "The Study of Hiberno-English" (Jeffrey L. Kallen) surveys some aspects of research on the language and offers a historical context for the subsequent papers. "A Tape-Recorded Survey of Hiberno-English in Its Context" (T. M. Tilling) reports on the early stages of an island-wide survey of the English…

  18. [Behavioral Objectives in English.

    ERIC Educational Resources Information Center

    Meade, Richard; And Others

    1970-01-01

    This edition of the "Virginia English Bulletin" is devoted primarily to articles about behavioral objectives and the teaching of English. In "Behavioral Objectives for English?" Richard A. Meade argues that these objectives ought to include the acquisition not only of skills and knowledge but also of understandings, insights, and feelings. He also…

  19. 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…

  20. English Teaching Profile: Malaysia.

    ERIC Educational Resources Information Center

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

    The status of the use and instruction of English in Malaysia, where it is a commonly-used second language, is described. The following topics are discussed: (1) the general status and role of English in Malaysian society in recent years; (2) English within the educational system (preschool, elementary, secondary, higher, adult, military, prison,…

  1. 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…

  2. English Teaching Profile: Colombia.

    ERIC Educational Resources Information Center

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

    This profile of the English language teaching situation in Colombia discusses the role of English in the educational system and in Colombian society. The status of English as the country's first foreign language is examined. It is noted that because Spanish is sufficient for most needs and because there is a relatively small number of Colombians…

  3. 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…

  4. 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…

  5. 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…

  6. Modern Apprenticeships in English Professional Football

    ERIC Educational Resources Information Center

    Monk, Des; Olsson, Cliff

    2006-01-01

    Purpose: This paper will examine the two year modern apprenticeship undertaken by trainees in the English professional football industry. Design/methodology/approach: Representatives of seven clubs were interviewed in the summer of 2005; all of them were responsible for youth development in their club. These interviews were the first of what will…

  7. 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;…

  8. 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…

  9. 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.

  10. 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.

  11. 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…

  12. 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…

  13. 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)

  14. 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,…

  15. Black English: A Community Language.

    ERIC Educational Resources Information Center

    Davis, France A.

    Black English, the particular variation of the English language used by many American Negroes, is frequently condemned as inferior to standard English by arbiters of language usage, but many Negroes find the structures and style of black English satisfactory for their communication needs. Black English is the result of a complex, developmental…

  16. 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…

  17. 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…

  18. English: History, Diversity and Change.

    ERIC Educational Resources Information Center

    Graddol, David, Ed.; And Others

    Essays examine development of the English language from Old English to the present, characteristics and use of contemporary varieties, and what the language means to speakers around the world. "English Voices" (Joan Swann) raises issues and questions about variation in English, to be addressed in later chapters. "English Manuscripts: The Emergence…

  19. Teratogenic drugs and their drug interactions with hormonal contraceptives.

    PubMed

    Ahn, M R; Li, L; Shon, J; Bashaw, E D; Kim, M-J

    2016-09-01

    The US Food and Drug Administration (FDA) Guidance for Industry-Drug Interaction Studies, recommends that a potential human teratogen needs to be studied in vivo for effects on contraceptive steroids.(1) This article highlights the need to evaluate the drug-drug interactions (DDIs) between drugs with teratogenic potential and hormonal contraceptives (HCs) during drug development. It also addresses the FDA's effort of communicating DDI findings in product labels to mitigate the risk of unintended pregnancy. PMID:27090193

  20. 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.

  1. Teaching English in Francophone Senegal.

    ERIC Educational Resources Information Center

    Davis, Kay

    2002-01-01

    Examines the English teaching situation in the African Francophone country of Senegal. Discusses education in general in Senegal, English clubs, English teacher preparation, exchange and study abroad programs, and professional activities and organizations. (Author/VWL)

  2. 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. PMID:18991964

  3. 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…

  4. 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…

  5. 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…

  6. SPOKEN ENGLISH FOR TURKS.

    ERIC Educational Resources Information Center

    WISE, SHELDON; AND OTHERS

    "SPOKEN ENGLISH FOR TURKS," BASED ON ROBERT B. LEES'"KONUSULAN INGILIZCE" (WASHINGTON, D.C., AMERICAN COUNCIL OF LEARNED SOCIETIES, 1957), COMPRISES A GRADED AND CONTROLLED SERIES OF BEGINNING TO ADVANCED TEXTS FOR TURKISH STUDENTS OF ENGLISH AT COLLEGE PREPARATORY LEVEL. ORAL-AURAL IN APPROACH, A KEY FEATURE OF THE SERIES IS ITS USE OF A…

  7. Teaching English in Japan.

    ERIC Educational Resources Information Center

    Kitao, Kenji, Ed.; And Others

    English language instruction, which is considered very important in Japan, is offered in 90 percent of all secondary schools and is studied by almost all students, even though it is an elective subject. English is considered a cultural and commercial link with the western world and has been taught in Japan since the mid-nineteenth century. Most…

  8. Black English: Two Viewpoints.

    ERIC Educational Resources Information Center

    Kleederman, Frances

    This paper focuses on the two main schools of thought concerning the structure of Black English and its relationship to other dialects. One approach is that of the social dialectologists who claim that Black English shares features and origins of white non-standard Southern speech; the frequency with which specific features occur in actual speech…

  9. California's English Learner Students

    ERIC Educational Resources Information Center

    Hill, Laura E.

    2012-01-01

    English Learner (EL) students in California's schools are numerous and diverse, and they lag behind their native-English-speaking peers. Closing the achievement gap for EL students has been a long-standing goal for California educators, and there are some signs of success. Now that EL funding and curriculum issues are receiving a fresh level of…

  10. English Loanwords in Japanese.

    ERIC Educational Resources Information Center

    Kay, Gillian

    1995-01-01

    Examines the historical and cultural contexts of word borrowing from English into Japanese, processes of nativization, and functions served by English loanwords. Notes that linguistic and cultural borrowing is to some extent kept separate from native language and culture, resulting in a Japanese/Western dichotomy in Japanese life and language. (20…

  11. The Customized English Kit.

    ERIC Educational Resources Information Center

    York, Ella Mae

    The courses in the English department at Arizona Western College are organized into one-credit modules and three-credit courses. For the associate degree, each student must take six credits of English; i.e., six modules or two three-credit courses. Those students who decide to take modules usually take three modules each semester, but they may…

  12. Learning English, Learning Science

    ERIC Educational Resources Information Center

    Nelson, Virginia

    2010-01-01

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

  13. 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 book places literary analysis…

  14. 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.

  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. English Around the World.

    ERIC Educational Resources Information Center

    Marquardt, William F.; And Others

    A feature of this aural-oral program for teaching English language skills to non-English speaking children in the primary grades is the colorfully illustrated, international context in which the pupils are introduced to customs and styles from around the world. The course consists of (1) teachers' guidebooks with detailed instructions for lesson…

  17. 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…

  18. English Learners: Reaching the Highest Level of English Literacy.

    ERIC Educational Resources Information Center

    Garcia, Gilbert C., Ed.

    This collection of papers examines the critical literacy development of English learners, focusing on English reading instruction in an immersion setting, English language development, and cultural issues pertaining to English learners in and out of the classroom. The 16 papers include the following: (1) "Reading and the Bilingual Student: Fact…

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

  20. Constructing English as a Ugandan Language through an English Textbook

    ERIC Educational Resources Information Center

    Stranger-Johannessen, Espen

    2015-01-01

    English is a national language in Uganda and is widely used in elite areas such as politics and business, but most Ugandans master English to only a limited degree. In this situation, English can be seen as either a foreign language or a second language--influencing how English is taught. One goal of language teaching espoused in this article is…

  1. English(es) in Urban Contexts: Politics, Pluralism, and Possibilities

    ERIC Educational Resources Information Center

    Kirkland, David E.

    2010-01-01

    English as taught in city schools does not always reflect the Englishes city students travel with. Their urban English landscape is enriched by a procession of many voices that march in various directions in, around, and through the monuments of the city. These languages--Englishes, in this case--which have been traded on through various public…

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

    PubMed

    Gaillard, Pieter J

    2011-11-01

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

  3. 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

    ... checklists for use by FDA review staff. In the Federal Register of August 13, 2012 (77 FR 48159), FDA...; 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...

  4. The Branding of English and the Culture of the New Capitalism: Representations of the World of Work in English Language Textbooks

    ERIC Educational Resources Information Center

    Gray, John

    2010-01-01

    Coinciding with the global boom in commercial English language teaching is the development of a sizeable publishing industry in which UK-produced textbooks for the teaching of English as an international or foreign language are core products. This article takes the view that these "curriculum artefacts" can also be understood as "cultural…

  5. 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

  6. My Hesitation to Speak English

    ERIC Educational Resources Information Center

    Oda, Naruha

    2015-01-01

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

  7. English Teachers' Journal (Israel), 1991.

    ERIC Educational Resources Information Center

    English Teachers' Journal (Israel), 1991

    1991-01-01

    This document consists of the two issues of "English Teachers' Journal (Israel)" issued during 1991. Contents include: "Introduction for English Teachers"; "Announcements for Bagrut Teachers and Examiners"; "News from E.T.A.I. (English Teachers' Association of Israel)" (Ephraim Weintroub); "Learning English During the 'Emergency'"; "Immigrant…

  8. History of the English Language.

    ERIC Educational Resources Information Center

    Regional Curriculum Project, Atlanta, GA.

    This curriculum guide, developed for pre-kindergartners through grade 12 as part of the total English curriculum, is concerned with the English language as it is now known and as it evolved from its Indo-European roots. Materials include (1) an overview of the origin and development of the English language from Old English through middle English…

  9. Standards and Dialects in English.

    ERIC Educational Resources Information Center

    Shopen, Timothy; Williams, Joseph M.

    A collection of essays on linguistic variation in English that distinguishes communities and social groups from one another includes: "Standard English: Biography of a Symbol" (Shirley Brice Heath); "The Rise of Standard English" (Margaret Shaklee); "English Orthography" (Wayne O'Neil); "How Pablo Says 'Love' and 'Stove'" and "An Afterword: How…

  10. English Language Teaching in Greece.

    ERIC Educational Resources Information Center

    Adoniou, Misty

    2001-01-01

    Highlights English language teaching in Greece, both in the government school system and in private English language education, focusing on the teachers, the classrooms, the classroom and syllabus, and inservice support. Discusses English in higher education, opportunities for teachers in Greece, and support for all teachers of English in Greece.…

  11. A comparative study of the CYP450 inhibition potential of marketed drugs using two fluorescence based assay platforms routinely used in the pharmaceutical industry.

    PubMed

    Kajbaf, Mahmud; Longhi, Raffaele; Montanari, Dino; Vinco, Federica; Rigo, Monica; Fontana, Stefano; Read, Kevin D

    2011-01-01

    Semi-automated high throughput screening for the inhibition of major human cytochrome P450 enzymes (1A2, 2C9, 2C19, 2D6 and 3A4) expressed in Escherichia Coli (Cypex bactosomes) or human lymphoblastoid cells (Gentest cDNA microsomes) using fluorescent probes has been evaluated using 68 marketed drugs. In general lower IC50 values were obtained with Cypex bactosomes compared with Gentest cDNA microsomes. This could be due to use of higherconcentration of protein and also the lower activity of Gentest cDNA microsomes. Notably, when compared with in vivo clinical drug-drug interactions (cDDIs) gathered from clinical studies reported in the scientific literature Cypex bactosome data was better at predicting in vivo cDDI. Consequently, from the data obtained in this comparative study, a fluorescence based assay using Cypex bactosomes is more suitable as a front-line screen for the prediction of potential downstream CYP450 driven cDDIs.

  12. English for Business

    ERIC Educational Resources Information Center

    Moulin, Andre

    1974-01-01

    Examines four publications meant for intermediate or even advanced learners of English: first, two handbooks of commercial correspondence, then, two methods designed to develop the four basic language skills. (Author/PMP)

  13. Billing in Plain English.

    ERIC Educational Resources Information Center

    Hughes, Sarah Jane

    1987-01-01

    The author describes the efforts of the Federal Trade Commission to make credit communications more readable and informative. The group working on the project uses "plain English" as the writing model for forms and manuals. (CH)

  14. The Hyphen in English.

    ERIC Educational Resources Information Center

    Pearce, Michael

    1978-01-01

    Even English speakers do not always know when to use a hyphen. Examples are given of some fairly clear-cut cases where the hyphen should be used, leading to the formulation of some usable rules. (IFS/WGA)

  15. Club Drugs

    MedlinePlus

    ... Rohypnol, ketamine, as well as MDMA (ecstasy) and methamphetamine ( Drug Facts: Club Drugs , National Institute on Drug ... Club Drugs , National Institute on Drug Abuse, 2010). Methamphetamine is a powerfully addictive stimulant associated with serious ...

  16. Pharmaceutical Industry in Syria

    PubMed Central

    2010-01-01

    The aim of this article is to present the development of the pharmaceutical industry in Syria using national and international public data sources. At the end of the 80ies, the pharmaceutical industry in Syria was very poor, covering 6% of the national needs. In less than 20 years, with the government support in terms of legal frame and strategic political engagement, the Syrian pharmaceutical industry finally covered almost 90% of the national needs, in terms of drugs, and exported drugs in around 52 Arabian countries. Beyond covering the local market, the main added values of this huge development consisted in exporting drugs in amount of 150 million dollars per year and providing jobs for 17000 Syrian people, out of which around 85% are women. Strong and weak points of the pharmaceutical sector are taken into consideration in the article and further interventions to support a sustainable development are proposed by the author. PMID:20945828

  17. 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…

  18. 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…

  19. Workplace Literacy: Developing and Implementing an ESL Curriculum for Limited English Proficient Poultry Workers.

    ERIC Educational Resources Information Center

    Merlin, Shirley B.

    The report describes the development and implementation of an English-as-a-Second-Language (ESL) program for limited-English-proficient employees of the poultry industry. The program, undertaken at James Madison University (Virginia), was funded initially in 1991 by the federal government and has continued with funding from two poultry companies.…

  20. The Third Way: A Call for Breaking the Dependency on the Mainstream English Language Teaching

    ERIC Educational Resources Information Center

    Davari, Hossein; Aghagolzadeh, Ferdows; Golfam, Arsalan; Kambuziya, Aliyeh Kord Zafaranlu

    2014-01-01

    The worldwide spread of English, especially through the tenets and assumptions of the mainstream English language teaching (ELT) has had ideological, socio-cultural and political implications in the field of education. Reviewing these tenets and assumptions, this paper attempts to reveal this growing industry through publicizing the spread of…

  1. The Spread of English: From France to a More General Perspective.

    ERIC Educational Resources Information Center

    Truchot, Claude

    1997-01-01

    Outlines a framework for analyzing the spread of English in eight areas: the sciences, business and industry, culture and media, daily life, education, language contact phenomena (codeswitching, linguistic borrowing), attitudes toward English, and language policies. Specific focus is on the situation in France, but provides a perspective…

  2. Making an Economic Impact: Higher Education and the English Regions. Research Report

    ERIC Educational Resources Information Center

    Kelly, Ursula; McLellan, Donald; McNicoll, Iain

    2010-01-01

    This is the first published study of the impact of the higher education sector on the English regions. This study presents key economic features of UK higher education in the academic year 2007/08 and those aspects of its contribution to the nine English regions that can be readily measured. The sector is analysed as a conventional industry,…

  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. Drug allergies

    MedlinePlus

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

  5. 21 CFR 207.40 - Establishment registration and drug listing requirements for foreign establishments.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Establishment registration and drug listing requirements for foreign establishments. 207.40 Section 207.40 Food and Drugs FOOD AND DRUG ADMINISTRATION... in the English language. (c) Each foreign drug establishment required to register under paragraph...

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

    ERIC Educational Resources Information Center

    Zhu, Wenzhong; Liao, Fang

    2008-01-01

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

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

    ERIC Educational Resources Information Center

    Kilickaya, Ferit

    2009-01-01

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

  8. The Trouble Is English: Reframing English Studies in Secondary Schools

    ERIC Educational Resources Information Center

    Brauer, Lydia; Clark, Caroline T.

    2008-01-01

    Sybil Wilson is a composite representation of an English teacher that typifies much of what most preservice English teachers have seen and experienced in U.S. classrooms. The authors' aim is to articulate textual frameworks often competing and unnamed in English curriculum (and evident in Sybil's classroom) and to argue for a particular reframing…

  9. THE TEACHING OF ENGLISH TO NON-ENGLISH-SPEAKING MIGRANTS.

    ERIC Educational Resources Information Center

    VITO, LAWRENCE

    THIS PROVISIONAL GUIDE FOR TEACHING ENGLISH TO NON-ENGLISH SPEAKING MIGRANTS PRESENTS THE USUAL ENGLISH LINGUISTIC PROBLEMS OF SPANISH-SPEAKING LEARNERS--CONSONANT SOUND PROBLEMS, VOWEL SOUND PROBLEMS, CONSONANT CLUSTER PROBLEMS, LANGUAGE RHYTHM PROBLEMS, AND INTONATION PROBLEMS. AIDS TO SPANISH USAGE AND PRONUNCIATION, INCLUDING VOWEL SOUNDS,…

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

    ERIC Educational Resources Information Center

    Alimi, Modupe

    2011-01-01

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

  11. African American Evaluations of Black English and Standard American English.

    ERIC Educational Resources Information Center

    White, Michael J.; Vandiver, Beverly J.; Becker, Maria L.; Overstreet, Belinda G.; Temple, Linda E.; Hagan, Kelly L.; Mandelbaum, Emily P.

    1998-01-01

    Studied the perceptions of 55 African American undergraduates about Black English. Students identified as not having a committed Black identity evaluated Black English as lower in status than those students with a committed Black identity. Black English was not perceived as reflecting higher social solidarity. (SLD)

  12. English in the Digital Age: Making English Digital

    ERIC Educational Resources Information Center

    Beavis, Catherine

    2010-01-01

    Despite the emphasis in the press and elsewhere on the print-based nature of English curriculum, opportunities to develop digital English, with attention to web-based and multimodal forms of text, literacy, location, and activity, are present in the draft national (Australian) curriculum for English, alongside more traditional forms. This paper…

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  14. The English of Business Is the Business of English.

    ERIC Educational Resources Information Center

    Versluis, Edward B.

    Three arguments lead to the conclusion that the English of business is the business of English. First, reluctance to fully appreciate the English of Business stems in part from a serious misunderstanding about the development of written language in the Western tradition. While studying folktales and the origins of myths has made an awareness of…

  15. 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…

  16. Forest Park English Department Revisited.

    ERIC Educational Resources Information Center

    Friedrich, Dick; Harris, Angela

    1999-01-01

    Provides a retrospective update of a 1974 profile of the English Department at St. Louis's Forest Park Community College. Describes the campus, English department, internal governance, courses taught, professional activities, and departmental spirit in relationship to its 1974 profile. (SC)

  17. Moving beyond Intermediate English Proficiency

    ERIC Educational Resources Information Center

    Jewell, Mary

    2009-01-01

    Too many English learners get stuck at intermediate levels of English language proficiency. In this article, teacher Mary Jewell describes how she uses literature and scaffolds to ensure that students develop academic language.

  18. Role of Hepatic Drug Transporters in Drug Development.

    PubMed

    Liu, Houfu; Sahi, Jasminder

    2016-07-01

    Hepatic drug transporters can play an important role in pharmacokinetics and the disposition of therapeutic drugs and endogenous substances. Altered function of hepatic drug transporters due to drug-drug interactions (DDIs), genetic polymorphisms, and disease states can often result in a change in systemic and/or tissue exposure and subsequent pharmacological/toxicological effects of their substrates. Regulatory agencies including the US Food and Drug Administration, European Medicines Agency, and Japan Pharmaceuticals and Medical Devices Agency have issued guidance for industry on drug interaction studies, which contain comprehensive recommendations on in vitro and in vivo study tools and cutoff values to evaluate the DDI potential of new molecular entities mediated by hepatic drug transporters. In this report we summarize the latest regulatory and scientific progress of hepatic drug transporters in clinical DDIs, pharmacogenetics, drug-induced liver injury (DILI), as well as methods for predicting transporter-mediated pharmacokinetics and DDIs. PMID:27385168

  19. In vitro evaluation of metabolic drug-drug interactions: a descriptive and critical commentary.

    PubMed

    Li, Albert P

    2007-01-01

    Adverse drug-drug interactions represent a major challenge for the pharmaceutical industry. Recently, in vitro approaches for the evaluation of metabolism-related drug-drug interactions have been developed. These in vitro approaches are found to be useful in the assessment of clinical drug-drug interaction potential of new chemical entities and to aid the understanding of clinically significant drug-drug interactions observed with existing drugs. The general methods for the evaluation of drug-drug interactions using in vitro, human-based experimental systems are described and critically reviewed.

  20. 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.

  1. 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. PMID:18301810

  2. Drug Safety

    MedlinePlus

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

  3. Style and Variables in English.

    ERIC Educational Resources Information Center

    Shopen, Timothy, Ed.; Williams, Joseph M., Ed.

    A collection of articles on the kinds of variation in English that one finds within the language of one group or one person includes: "The English Language as Rule-Governed Behavior" (Timothy Shopen); "The English Language as Use-Governed Behavior" (Joseph M. Williams); "Styles" (Ann D. Zwicky); "The Organization of Discourse" (Charlotte Linde);…

  4. Fundamentals of English Language Teaching.

    ERIC Educational Resources Information Center

    Kitao, S. Kathleen; Kitao, Kenji

    English is not the most widely spoken language in the world, but it is the most widely used by non-native speakers, making the teaching of English as a Second Language a very important endeavor. This book provides an overview of English language teaching, giving the reader a general background on the issues related to language…

  5. Effective Instruction for English Learners

    ERIC Educational Resources Information Center

    Calderon, Margarita; Slavin, Robert; Sanchez, Marta

    2011-01-01

    The fastest-growing student population in U.S. schools today is children of immigrants, half of whom do not speak English fluently and are thus labeled English learners. Although the federal government requires school districts to provide services to English learners, it offers states no policies to follow in identifying, assessing, placing, or…

  6. ASL? English? Which? Comparing Comprehension.

    ERIC Educational Resources Information Center

    Eagney, Peggy

    1987-01-01

    Comparisons of 91 deaf children's (ages 5-15) understanding of 25 sentences presented in American Sign Language (ASL), simplified English, and standard English showed no significant differences in the children's ability to comprehend the three different forms. Findings do not support proposals to substitute ASL or simplified English for standard…

  7. Project English Summaries, March 1970.

    ERIC Educational Resources Information Center

    Haughey, Charles F.; And Others

    Information concerning Project English, which is being carried out at 14 universities and 1 State Department of Education through the support of the Office of Education, is provided in summary format. Project English is concerned with the development of English curriculum for Grades K through 12 and with the development of curriculum for…

  8. English Language Teaching Profile: Uruguay.

    ERIC Educational Resources Information Center

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

    This profile in outline form of the English language teaching situation in Uruguay discusses the role of English within Uruguayan society and within the educational system. Though English is quite widely used for reading scientific, technical and medical publications, and while it is considered important culturally in higher professions, it is not…

  9. English as an African Language.

    ERIC Educational Resources Information Center

    Desai, Gaurav

    1993-01-01

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

  10. English Takes Root in Vietnam.

    ERIC Educational Resources Information Center

    Yablonka, Marc Phillip

    1999-01-01

    English has emerged as an important language in Vietnam, and English-as-a-Second-Language (ESL) education exists at all levels of schooling and in business. This paper explains Vietnam's post-embargo quest for English, the effect of economic hardships on education in Vietnam, incoming ESL instructors, and the past, present, and future of languages…

  11. Teachers' Habitus for Teaching English

    ERIC Educational Resources Information Center

    Flynn, Naomi

    2015-01-01

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

  12. English Teachers' Journal (Israel), 1992.

    ERIC Educational Resources Information Center

    English Teachers' Journal (Israel), 1992

    1992-01-01

    This document consists of the two issues of "English Teachers' Journal (Israel)" issued during 1992. Articles include: "Information for English Teachers"; "Announcements for Bagrut Teachers and Examiners"; "News from Educational Television" (Lily Vered and Others); "News from E.T.A.I. (English Teachers' Association of Israel)" (Brenda Liptz and…

  13. Symposium: What Is College English?

    ERIC Educational Resources Information Center

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

    2013-01-01

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

  14. The English Face of Paris.

    ERIC Educational Resources Information Center

    Senior, Nancy

    1993-01-01

    Whereas in Quebec the use of English is seen as a threat to the French language, English words are often used in France, particularly in advertising. They imply certain values: British words suggest elite status; U.S. ones promise technological progress, freedom, and fun. The adaptation of English words is described. (18 references) (Author/LB)

  15. English Language Teaching Profile: Canada.

    ERIC Educational Resources Information Center

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

    This profile in outline form of the English language teaching situation in Canada discusses the role of English within Canadian society and within the educational systems in the provinces. The discussion takes place within the context of the Official Languages Act of 1969, which declared English and French official languages for all government…

  16. [English Electives and New Courses.

    ERIC Educational Resources Information Center

    Shuman, R. Baird; And Others

    1971-01-01

    This edition of the "Virginia English Bulletin" is devoted primarily to articles about multiple-elective programs in high school English classes. These articles include: (1) "Multiple Electives in the English Curriculum" by R. Baird Shuman; (2) "Creative Dramatics: A Natural for the Multiple Electives Program" by Charles R. Duke; (3) "Spotsylvania…

  17. An English-Panjabi Dictionary.

    ERIC Educational Resources Information Center

    Bailey, T. Grahame

    This English-Panjabi dictionary was compiled from about 5800 English words and expressions. Not intended to be exhaustive, the dictionary contains expressions that are considered useful to Europeans for communication with the Panjabis. It may also be useful to Panjabi students in their use of English. In addition to the dictionary proper, an…

  18. Teaching English to American Indians.

    ERIC Educational Resources Information Center

    Reyhner, Jon

    Many practices in Bureau of Indian Affairs (BIA) schools were negative, but this paper emphasizes the positive efforts that were made throughout their history, especially in regard to teaching English. The Carlisle Indian School, which opened in 1879, encouraged the use of English through an English language student newspaper and frequently…

  19. Chinese English Learners' Strategic Competence

    ERIC Educational Resources Information Center

    Wang, Dianjian; Lai, Hongling; Leslie, Michael

    2015-01-01

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

  20. English Examination Questions in Australia

    ERIC Educational Resources Information Center

    McCurry, Doug

    2010-01-01

    This paper outlines the analysis of subject English in a report written for the Commonwealth government entitled "Year 12 Curriculum Content and Achievement Standards" (CCAS). This report could not find "a core of common content (either topics or skills) in senior English (including Literature)". In the light of the diversity of English courses…

  1. The Ecology of Global English

    ERIC Educational Resources Information Center

    Canagarajah, A. Suresh

    2007-01-01

    Global English is under contestation. Although some consider lingua franca English (LFE) as a neutral medium or code that does not belong to any specific culture or nationality, others see the deceptive nature of this linguistic globalization. Along with Spring (2007/this issue), they see global English as embodying partisan interests and values.…

  2. Nanomedicine: Industry-wise research

    NASA Astrophysics Data System (ADS)

    Eaton, Mike

    2007-04-01

    Academic participation in nanomedicine research is welcomed by European industries. The recipe for success may or may not include creativity, but it will certainly require awareness of drug development and approval processes.

  3. Questioning Linguistic Instrumentalism: English, Neoliberalism, and Language Tests in Japan

    ERIC Educational Resources Information Center

    Kubota, Ryuko

    2011-01-01

    Linguistic instrumentalism, which underscores the importance of English skills for work and for achieving individual economic success, has influenced language education policies and proliferated the language teaching and testing industry in Japan. Linguistic instrumentalism is linked to the notion of human capital (i.e., skills deemed necessary…

  4. Cultivating Civilization: The Age of the English Coffee House.

    ERIC Educational Resources Information Center

    Bakken, Timothy

    1994-01-01

    Contends that the English coffee house was a social and economic institution that served as a daily newspaper and a center of commerce. Discusses coffee house origins, development, significance, and decline. Concludes that the coffee house served as a transition from medieval society to an age of rationality and industry. (CFR)

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

    ERIC Educational Resources Information Center

    El Paso Community Coll., TX. Literacy Center.

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

  6. Computers in Teaching English.

    ERIC Educational Resources Information Center

    Davis, James E., Ed.; Davis, Hazel K., Ed.

    1983-01-01

    The 26 articles in this journal issue discuss the use of the computer in the English classroom. Among the topics and applications discussed are (1) computer assisted invention, (2) word processing, (3) overcoming computer anxiety, (4) using computers in technical writing classes, (5) grading student essays by computer, (6) the experiences of an…

  7. Trends in European English.

    ERIC Educational Resources Information Center

    Wilkinson, Robert

    It is proposed that a European variety of English without native speakers is emerging as a language of international communication in Europe. This is a consequence of many factors, including the strength of the American economy, the breadth and depth of American research in science and technology, the pervasive influence of American-style popular…

  8. Patterns of English Pronunciation.

    ERIC Educational Resources Information Center

    Bowen, J. Donald

    This pronunciation manual for the study of English as a foreign/second language can be used with beginning as well as intermediate or advanced students. The text is organized in three parts or cycles. Part One is an introduction to selected features of pitch and stress and an inventory of the vowels and consonants, with contextual illustrations of…

  9. English Education and Aging.

    ERIC Educational Resources Information Center

    Gillis, Candida

    1983-01-01

    Suggests that English teachers are in an excellent position to help students learn about the aged and aging because they know literature that treats the joys and pains of later life and they understand how language shapes and reflects cultural attitudes. Proposes objectives and presents samples of activities to be used in an aging unit. (MM)

  10. This World of English

    ERIC Educational Resources Information Center

    DeVries, Ted; Tovatt, Anthony

    1971-01-01

    Reviews of articles selected from various other publications that may be of interest to readers of the English Journal": strategy for keeping a job in today's schools; how and where to publish an article; methods for creative teaching; teaching non achievers; etc. (RB)

  11. The Paradox of English

    ERIC Educational Resources Information Center

    O'Hara-Davies, Breda

    2010-01-01

    This paper summarises the results of a qualitative study which focused on 60 Malay students aged 17-19 years in Brunei Darussalam. It explored the interplay of factors that colour the participants' attitude to the English language and its role in their education as well as in their lives. Brunei's status as a former British protectorate was taken…

  12. English Leadership Quarterly. 1991.

    ERIC Educational Resources Information Center

    Strickland, James, Ed.

    1991-01-01

    These four issues of the English Leadership Quarterly represent the quarterly for 1991. Articles in number 1 deal with whole language and include: "CEL: Shorter and Better" (Myles D. Eley); "Toward a New Philosophy of Language Learning" (Kathleen Strickland); "Whole Language: Implications for Secondary Classrooms" (Barbara King-Shaver); "Whole…

  13. English in the City

    ERIC Educational Resources Information Center

    Hamilton, Greg

    2005-01-01

    Several years ago, Ruth Vinz, other colleagues at the Teachers College and Greg Hamilton worked together on a book for English teachers "Becoming (Other)wise: Enhancing Critical Reading Perspectives" that challenged some of the more popular and mainstream conceptions of a multicultural literature education. Principles theorized by the team while…

  14. [Coyote Tales. English Version.

    ERIC Educational Resources Information Center

    Albert, Roy; And Others

    Hopi storytellers told, in Hopi, 20 stories for this supplementary reading series. Each story was translated into English, graded (1.1 to 3.8), and illustrated. These stories normally serve to entertain as well as to instruct both children and adults during the winter nights. Several of the stories have Coyote as the central character. He typifies…

  15. "Right" in Singapore English

    ERIC Educational Resources Information Center

    Tan, Angela

    2010-01-01

    Singapore English has been, and still is, an enigma for many scholars and researchers. In recent years, much attention has been given to the analysis of its particles. However, rather than focusing on the analysis of one particle or several particles and how they operate at the level of the sentence, this paper looks at a particular phenomenon in…

  16. Personal Reference in English.

    ERIC Educational Resources Information Center

    Murphy, Gregory L.

    1988-01-01

    Presents a systematic investigation of the factors underlying the choice of personal reference. Five experiments examine how native-English-speaking undergraduates of Brown University refer to a professor or student in various situations. The Rule of Polite Reference (RPR) explains how speakers choose the way they will refer to a person in a given…

  17. English Leadership Quarterly, 1993.

    ERIC Educational Resources Information Center

    Strickland, James, Ed.

    1993-01-01

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

  18. Teaching English Through Action.

    ERIC Educational Resources Information Center

    Segal, Bertha

    A complete teaching guide is presented for teaching English as a second language (ESL) according to the Total Physical Response (TPR) approach as was researched by James J. Asher of San Jose (California) State University. The method is based on the following premises: (1) understanding the spoken language should be developed far in advance of…

  19. English Leadership Quarterly, 1995.

    ERIC Educational Resources Information Center

    Kiernan, Henry, Ed.

    1995-01-01

    These 4 issues of the English Leadership Quarterly comprise volume 17, published during 1995. Articles in number 1 deal with multicultural and multiethnic literature, and are, as follows: "Guidelines for Selecting European Ethnic Literature for Interdisciplinary Courses" (Sandra Stotsky); "Striving for Kinship within Diverse Communities" (Peter…

  20. English Day by Day.

    ERIC Educational Resources Information Center

    Roddy, Michael

    This book is designed as a text and workbook for students of English as a Second Language. The workbook stresses grammar, reading, writing, and pronunciation in the context of real-life situations where competency in written and conversational skills and in problem-solving can be critical. The format is sequential. Thirteen units on different…

  1. English 3135: Visual Rhetoric

    ERIC Educational Resources Information Center

    Gatta, Oriana

    2013-01-01

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

  2. What Is Career English?

    ERIC Educational Resources Information Center

    Brevard County School Board, Cocoa, FL.

    English courses which involve the language arts skills and which should be incorporated into major career areas are described in this guide. The guide also describes the units, procedures, activities, supplementary materials, and evaluation tools and is keyed--by number--to the State Accreditation Standards and assessment objectives. Teaching…

  3. Why College English?

    ERIC Educational Resources Information Center

    Logan, Shirley Wilson

    2006-01-01

    This author asserts that college English should provide students with certain communicative skills that enable them to analyze rhetorical effect and produce rhetorically effective texts, including those to be read, those to be viewed as images, those to be heard, and those not to be heard. Recently, new books on visual rhetoric, the rhetoric of…

  4. Why Teach English?

    ERIC Educational Resources Information Center

    Martin, David

    2002-01-01

    Describes many reasons why the author decided to teach English as an occupation. Suggests that jobs should be ones people enjoy, ones they look forward to getting out of bed for in the morning. Notes that people ought to do what they excel at with no consideration for financial reward. Suggests that those who study good literature find epiphanies.…

  5. Countability in World Englishes

    ERIC Educational Resources Information Center

    Hall, Christopher J.; Schmidtke, Daniel; Vickers, Jamie

    2013-01-01

    In this study we explored variation in the countability of nouns in Outer Circle, Expanding Circle and lingua franca Englishes, a phenomenon which is frequently cited as a marker of Inner Circle norms in TESOL and of endonormative and emerging varieties in the Outer and Expanding Circles. We inspected a set of mass nouns like "information" and…

  6. Deriving Verbs in English

    ERIC Educational Resources Information Center

    Dixon, R. M. W.

    2008-01-01

    Phonological and semantic principles which underlie the derivation of verbs from nouns and adjectives in English are examined. There is intricate phonological conditioning for suffix "-ize" and for suffix "-(i)fy"; a third major process is zero derivation. These derivational processes cover more than a score of semantic relations (some with…

  7. English Only JAMAS.

    ERIC Educational Resources Information Center

    Cartagena, Juan

    1989-01-01

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

  8. Correlational Comparison in English

    ERIC Educational Resources Information Center

    Smith, Elizabeth Allyn

    2011-01-01

    This dissertation proposes a novel analysis of the syntax and semantics of Comparative Correlative sentences in English such as "the bigger they are, the harder they fall or the faster we drive, the sooner we'll get there." The analysis is cast in a framework that distinguishes between argument structure and word order, called…

  9. English Leadership Quarterly, 1992.

    ERIC Educational Resources Information Center

    Strickland, James, Ed.

    1992-01-01

    These four issues of the English Leadership Quarterly represent those published during 1992. Articles in number 1 deal with testing assessing, and measuring student performance, and include: "Real Evaluation: Portfolios as an Effective Alternative to Standardized Testing" (Kate Kiefer); "No More Objective Tests, Ever" (Carol Jago); "Process-Based…

  10. Assessment of Spoken English.

    ERIC Educational Resources Information Center

    Rolfe, Elizabeth

    This study examined the usefulness of an evaluation procedure designed to measure performance in spoken English. Rating involved assessment of the prose reading and conversation skills of 57 first-year students at Wellington Teachers' College, New Zealand. Specific topics of investigation included the consistency of "general impression" ratings…

  11. English Learning Environments.

    ERIC Educational Resources Information Center

    Walen, Harry L.

    The kinds of spaces needed to house the learning activities of today's school English program are discussed in this paper. The following spaces are recommended in the planning of new buildings or in the remodeling of existing buildings: (1) a space capable of seating several hundred persons for viewing plays and films and for large-group…

  12. English-Cinyanja Dictionary.

    ERIC Educational Resources Information Center

    Zambesi Mission, Mitsidi (Malawi).

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

  13. The Subject Is English

    ERIC Educational Resources Information Center

    Scott, Melanie

    2007-01-01

    Students will have to use language all their lives, whether they are signing off on stock investments, guiding airplanes to land, or writing the next great novel. Language is the stuff of communication, and English happens to be the most commonly used language in the world. However, Canadian schools do not adequately prepare young people to use…

  14. English in the City

    ERIC Educational Resources Information Center

    Hamilton, Greg

    2004-01-01

    This article focuses on the particular challenges, choices, and celebrations relevant to teaching in an urban setting. The speech of African American students is described as rich and reflective of the African American oral tradition. The article also discusses the meaning, rules and the evolution of African American English.

  15. Learning English Through Typewriting.

    ERIC Educational Resources Information Center

    Gay, Charles W.; And Others

    The purpose of this text is to teach typing to students of English as a second language. The authors feel that "the repetition of typing patterns can reinforce language habits, which are mastered through repetition. Conversely, language drills such as pattern practice will automatically increase typing speed and accuracy." Students will also…

  16. 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.

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

    ERIC Educational Resources Information Center

    Shen, Yuru

    2012-01-01

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

  18. 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)

  19. 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…

  20. 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.

  1. English Teachers' Journal (Israel), No. 19.

    ERIC Educational Resources Information Center

    Ministry of Education and Culture, Jerusalem (Israel).

    This journal, published in Israel, contains articles of interest to teachers of English as a second language, particularly those in Hebrew-English situations. This issue contains the following articles: (1) "Thirty Years of Israel -- in the English Class," by A. Sotto and L. Marnin; (2) "English in Grade Four," by E. Gelber; (3) "English Teaching…

  2. Drug Resistance

    MedlinePlus

    HIV Treatment Drug Resistance (Last updated 3/1/2016; last reviewed 3/1/2016) Key Points As HIV multiplies in the ... the risk of drug resistance. What is HIV drug resistance? Once a person becomes infected with HIV, ...

  3. 7 CFR 247.13 - Provisions for non-English or limited-English speakers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  4. 7 CFR 247.13 - Provisions for non-English or limited-English speakers.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 4 2011-01-01 2011-01-01 false Provisions for non-English or limited-English speakers... § 247.13 Provisions for non-English or limited-English speakers. (a) What must State and local agencies do to ensure that non-English or limited-English speaking persons are aware of their rights...

  5. 7 CFR 247.13 - Provisions for non-English or limited-English speakers.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 4 2012-01-01 2012-01-01 false Provisions for non-English or limited-English speakers... § 247.13 Provisions for non-English or limited-English speakers. (a) What must State and local agencies do to ensure that non-English or limited-English speaking persons are aware of their rights...

  6. 7 CFR 247.13 - Provisions for non-English or limited-English speakers.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 4 2013-01-01 2013-01-01 false Provisions for non-English or limited-English speakers... § 247.13 Provisions for non-English or limited-English speakers. (a) What must State and local agencies do to ensure that non-English or limited-English speaking persons are aware of their rights...

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

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 4 2014-01-01 2014-01-01 false Provisions for non-English or limited-English speakers... § 247.13 Provisions for non-English or limited-English speakers. (a) What must State and local agencies do to ensure that non-English or limited-English speaking persons are aware of their rights...

  8. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New... notice entitled ``Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications... the draft guidance for industry entitled ``Draft Guidance for Industry; Dietary Supplements:...

  9. Coarticulation Resistance in English /l/

    ERIC Educational Resources Information Center

    Bladon, R. A. W.; Al-Bamerni, Ameen

    1976-01-01

    Allophonic variations in the quality and voicelessness of British English Received Pronunciation /1/ were investigated, largely through their acoustic correlates as revealed by spectrography. (Author/RM)

  10. 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.

  11. 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.

  12. Communication Skills for the Cosmetology Industry.

    ERIC Educational Resources Information Center

    Rader, Wendy

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

  13. 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.

  14. 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.

  15. 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…

  16. 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…

  17. Giving Good Weight to Black English.

    ERIC Educational Resources Information Center

    Newell, R.C.

    1981-01-01

    This critical analysis of the usage of Black English in the classroom suggests that a change in teacher attitudes toward Black English will increase student ability and desire to learn standard English. (DA)

  18. Market structure and drug innovation.

    PubMed

    Pammolli, Fabio; Riccaboni, Massimo

    2004-01-01

    An explosion of knowledge and a growing array of tools and technologies have transformed modern drug R&D, while its cost has risen by a sizable amount. At the same time, the unchecked increase in health care and prescription drug spending has spawned cost containment policies that are restricting the demand for drugs in all major markets. This Perspective explores the interplay between technological advances and regulatory policies and their likely impact on the dynamics of the pharmaceutical industry.

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

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

    NASA Astrophysics Data System (ADS)

    Yeon, Sang-Hee

    2003-04-01

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

  1. English for the English: A Chapter on National Education.

    ERIC Educational Resources Information Center

    Sampson, George

    The basic importance of English in schools is the basis for this book. Following an introduction to George Sampson by the editor Denys Thompson, a preliminary by the author discusses the half-century that has passed since the enactment of the Education Act of 1870 in England. The place of the English language and literature in the early stages of…

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  3. Integrating Science and English Proficiency for English Language Learners

    ERIC Educational Resources Information Center

    Lee, Okhee; Buxton, Cory A.

    2013-01-01

    Despite the expectation that all students should achieve high academic standards, content area instruction and English for speakers of other languages instruction for English language learners (ELLs) have traditionally been conceptualized as separate domains, resulting in educational inequities for ELLs. This is because effective instruction to…

  4. Izon Syntax and the English of Izon-English Bilinguals

    ERIC Educational Resources Information Center

    Okunrinmeta, Uriel

    2011-01-01

    This study explores the influences that the Izon language manifests in the syntax of the English of Izon (Nigerian) speakers and makes a clear distinction between the influences that result in errors and those that result in permissible local variations, which indicates that the idea of treating all variations in the syntax of Nigerian English as…

  5. Teaching College English and English Education: Reflective Stories.

    ERIC Educational Resources Information Center

    McCracken, H. Thomas, Ed.; Larson, Richard L., Ed.; Entes, Judith, Ed.

    In this collection of 32 narrative essays, scholars and teachers of English and English education share their excitement as they reflect on their professional growth over the last 30 years. The firsthand stories in the collection represent "a study of theory and applied theory, grounded in personal experience and academic study over many years."…

  6. Online English-English Learner Dictionaries Boost Word Learning

    ERIC Educational Resources Information Center

    Nurmukhamedov, Ulugbek

    2012-01-01

    Learners of English might be familiar with several online monolingual dictionaries that are not necessarily the best choices for the English as Second/Foreign Language (ESL/EFL) context. Although these monolingual online dictionaries contain definitions, pronunciation guides, and other elements normally found in general-use dictionaries, they are…

  7. Baseball/Beisbol. Spanish-English, English-Spanish. Revised.

    ERIC Educational Resources Information Center

    Grosse, Philip

    The bilingual glossary, in both English-to-Spanish and Spanish-to-English, defines words and phrases related to the game of baseball as it is reported by Spanish-language newspapers and magazines in Mexico and the United States. A list of U.S. and Mexican baseball league teams is appended. (MSE)

  8. Axiological Role of English Adjectives in English Language Teaching

    ERIC Educational Resources Information Center

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

    2016-01-01

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

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

    ERIC Educational Resources Information Center

    Singhasak, Piyahathai; Methitham, Phongsakorn

    2016-01-01

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

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

    ERIC Educational Resources Information Center

    Thelamour, Barbara; Jacobs, D'Andrea L.

    2014-01-01

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

  11. Discontinued drugs in 2012: cardiovascular drugs.

    PubMed

    Zhao, Hong-Ping; Jiang, Hong-Min; Xiang, Bing-Ren

    2013-11-01

    The continued high rate of cardiovascular morbidity and mortality has attracted wide concern and great attention of pharmaceutical industry. In order to reduce the attrition of cardiovascular drug R&D, it might be helpful recapitulating previous failures and identifying the potential factors to success. This perspective mainly analyses the 30 cardiovascular drugs dropped from clinical development in 2012. Reasons causing the termination of the cardiovascular drugs in the past 5 years are also tabulated and analysed. The analysis shows that the attrition is highest in Phase II trials and financial and strategic factors and lack of clinical efficacy are the principal reasons for these disappointments. To solve the four problems (The 'better than the Beatles' problem, the 'cautious regulator' problem, the 'throw money at it' tendency and the 'basic researchbrute force' bias) is recommended as the main measure to increase the number and quality of approvable products. PMID:23992034

  12. Drug Abuse

    MedlinePlus

    ... as drugged driving, violence, stress, and child abuse. Drug abuse can lead to homelessness, crime, and missed work or problems with keeping a job. It harms unborn babies and destroys families. There are different types of treatment for drug abuse. But the best is to prevent drug ...

  13. Controlled drugs.

    PubMed

    2016-05-18

    Essential facts Controlled drugs are defined and governed by the Misuse of Drugs Act 1971 and associated regulations. Examples of controlled drugs include morphine, pethidine and methadone. Since 2012, appropriately qualified nurses and midwives can prescribe controlled drugs for medical conditions within their competence. There are some exceptions when treating addiction. PMID:27191427

  14. Ninth Grade English: Curriculum Guide.

    ERIC Educational Resources Information Center

    Harlandale Independent School District, San Antonio, TX. Career Education Center.

    The guide is arranged in vertical columns relating curriculum concepts in English to curriculum performance objectives, career concepts and career performance objectives, suggested teaching methods, and resource materials. State concepts for ninth grade English, as outlined in the Texas Education Agency "Bulletin 615" for instruction, are used in…

  15. Eighth Grade English: Curriculum Guide.

    ERIC Educational Resources Information Center

    Harlandale Independent School District, San Antonio, TX. Career Education Center.

    The guide is arranged in vertical columns relating curriculum concepts in English to curriculum performance objectives, career concepts and career performance objectives, suggested teaching methods, and resource materials. State concepts for eighth grade English, as outlined in the Texas Education Agency "Bulletin 615" for instruction, are used in…

  16. ACCA College English Teaching Mode

    ERIC Educational Resources Information Center

    Ding, Renlun

    2008-01-01

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

  17. Options for English Language Learners

    ERIC Educational Resources Information Center

    Minaya-Rowe, Liliana

    2008-01-01

    Between 69 percent and 90 percent of English language learners (ELLs) in middle and high schools were born in the United States and have been in U.S. schools since kindergarten still have not achieved the academic proficiency to succeed in an all-English mainstream program. Various ELL program options are available for school districts to…

  18. Racializing the Nonnative English Speaker

    ERIC Educational Resources Information Center

    Shuck, Gail

    2006-01-01

    This article identifies some discursive processes by which White, middle-class, native-English-speaking, U.S.-born college students draw on a monolingualist ideology and position themselves and others within a language-race-nationality matrix. These processes construct the speakers' Whiteness and nativeness in English as unmarked and normal; mark…

  19. Teaching English: The Two Traditions.

    ERIC Educational Resources Information Center

    Fiedler, Leslie A.

    1980-01-01

    Argues for the expansion of college English courses and the redefinition of "literature" to include such works as the books of Bram Stoker, H. Rider Haggard, and television and movie scripts as a way of keeping English "alive and well." (FL)

  20. English Linguistics, An Introductory Reader.

    ERIC Educational Resources Information Center

    Hungerford, Harold, Ed.; And Others

    The readings in this volume have been selected for college level and graduate students in English who need an introduction to English linguistics which is neither too advanced or specialized, but has a broad range of interests. The editors (Harold Hungerford, Jay Robinson, and James Sledd) have prepared this anthology to use in their own teaching,…

  1. Professional Memory and English Teaching

    ERIC Educational Resources Information Center

    Tarpey, Paul

    2009-01-01

    This article concerns the way that research into Professional Memory (PM) in English teaching might re-connect the school subject with constituencies--the individuals, communities and social values--it once served. By PM I mean the collective memories of a generation of English teachers which, when brought into conjunction with existing histories,…

  2. English for Petrochemical Plant Operators.

    ERIC Educational Resources Information Center

    Bynum, Henri Sue

    The development of a program and curriculum for instruction in technical English for Saudi Arabian petrochemical plant operator trainees studying in the United States for two years was undertaken by the University of South Alabama's English Language Center. The program was designed to accommodate (1) the degree of skills and prior learning of the…

  3. Community Attitudes toward Black English

    ERIC Educational Resources Information Center

    Hoover, Mary Rhodes

    1978-01-01

    Describes research in which 28 black parents and community people were polled as to their attitudes toward vernacular and standard Black English. Attitudes were assessed in four domains--school, home, community and playground--and in four channels--reading, speaking, writing and listening. Standard Black English was preferred in all domains and…

  4. Black English and Reluctant Judges.

    ERIC Educational Resources Information Center

    Glazer, Nathan

    1981-01-01

    Discusses "Martin Luther King Jr. Elementary School Children, et al. v Ann Arbor School District Board," a court decision requiring that teachers be instructed in the role and significance of Black English. Argues that the issues of educational achievement and Black English do not constitute a matter for the courts. (GC)

  5. Essential English for Micronesian Adults.

    ERIC Educational Resources Information Center

    Conrad, Jo Ann; Reinecke, Hank

    This student workbook is designed to help Micronesian adults learn everyday English. Its ten chapters move from simple one-word picture labeling to more abstract ideas in a spiraled fashion, reiterating the essential elements of the English language in different, more complicated ways. Subjects covered include names for everyday objects and…

  6. English Teaching at Lilydale High.

    ERIC Educational Resources Information Center

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

    2002-01-01

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

  7. English Pidgins: Form and Function.

    ERIC Educational Resources Information Center

    Mufwene, Salikoko S.

    1988-01-01

    Highlights similarities and variation in both form and function of English pidgins the world over. It is argued that English pidgins are related more by socio-historical conditions and directions of development than by details of their formal structure. Reference list includes 68 citations. (Author/DJD)

  8. Black English in New York.

    ERIC Educational Resources Information Center

    Dillard, J. L.

    1971-01-01

    Black English has existed for a considerable length of time in the North as well as in the South. West African slaves who came to New York in 1625 found a contact language useful and mandatory in order to function in the slave community. The earliest slaves in the New York area may have used Pidgin English, Pidgin Portuguese, or Pidgin French…

  9. Phonetic Change in Newfoundland English

    ERIC Educational Resources Information Center

    Clarke, Sandra

    2012-01-01

    Newfoundland English has long been considered autonomous within the North American context. Sociolinguistic studies conducted over the past three decades, however, typically suggest cross-generational change in phonetic feature use, motivated by greater alignment with mainland Canadian English norms. The present study uses data spanning the past…

  10. Solving the English Phonological Puzzle.

    ERIC Educational Resources Information Center

    Piper, Terry

    A research project was undertaken to investigate the acquisition of the English sound system by kindergarten children of various first language backgrounds. Sixteen children were selected from three kindergartens in Prince Rupert, British Columbia according to the following criteria: (1) no English was spoken by parents; (2) the child scored 3 or…

  11. Variations in Standard American English.

    ERIC Educational Resources Information Center

    McDavid, Raven I., Jr.

    1968-01-01

    A discussion of nonstandard varieties of English implies a standard variety. What "standard" English actually is should be defined in order to approach it in the classroom. C.C. Fries described it as the variety used by those who hold positions of trust and respect and conduct the important affairs of a community. This definition admits that what…

  12. IDRA Family English Literacy Initiative.

    ERIC Educational Resources Information Center

    Intercultural Development Research Association, San Antonio, TX.

    Five articles from this newsletter of the Intercultural Development Research Association (IDRA) describe IDRA programs that are part of the organization's family literacy efforts. "The Family English Literacy Project: Promoting Adult Literacy in San Antonio" outlines a program to provide English language literacy for 125 parents of children in…

  13. Films and the English Class.

    ERIC Educational Resources Information Center

    Donelson, Kenneth, Ed.

    1971-01-01

    The importance of film in the English classroom and its vitality in the English curriculum are discussed. Articles that comprise this issue of the bulletin are: The Trouble with Film Teaching by James E. Cutts; "You Ain't Heard Nothin' Yet" or Send Your Students to the Flicks Tonight by Bob Haskett; It's the Reel Thing: The Verite of Cinema Is…

  14. English Teaching Profile (Provisional): Venezuela.

    ERIC Educational Resources Information Center

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

    This profile of the English language teaching situation in Venezuela discusses the status of English in society and in the educational system. It also gives an account of Venezuelan political, economic, and social life. A description is given of the education system and reforms that have been proposed for nursery school through higher education.…

  15. Cultural Identity in Korean English

    ERIC Educational Resources Information Center

    Chang, Bok-Myung

    2010-01-01

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

  16. Evaluating Workplace English Language Programs

    ERIC Educational Resources Information Center

    Ekkens, Kristin; Winke, Paula

    2009-01-01

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

  17. English Language Development in Tunisia.

    ERIC Educational Resources Information Center

    Daoud, Mohamed

    1996-01-01

    Describes English language policy decisions and implementation strategies in Tunisia and highlights the problems accompanying them. The article emphasizes that Tunisia has entered a critical stage in the promotion of English as the language of economic, scientific, and technological development and that the educational system must develop programs…

  18. The Archives of "English Journal."

    ERIC Educational Resources Information Center

    Perrin, Robert

    A perusal of back issues of the "English Journal" since its beginnings in 1912 reveals a sense of continuity in the teaching profession. Over the years, the journal has addressed topics of interest to teachers. Some of these topics, even those from the earliest issues, shed light on current topics in English teaching, including the following: (1)…

  19. Importing Canagarajah's Global English Theories

    ERIC Educational Resources Information Center

    Shelton, Linda

    2007-01-01

    Should an academic have respect toward cultural differences, including variety in language? A. Suresh Canagarajah has written extensively about global English and its power over vernacular languages, stressing that language learning is not a politically neutral activity. English teachers carry with them the possibility of ideological domination…

  20. Trends in Industry Supervisors' Feedback on Business Communication Internships

    ERIC Educational Resources Information Center

    Sapp, David Alan; Zhang, Qin

    2009-01-01

    The purpose of this empirical study is to explore expectations of industry insiders and identify how student interns are performing in relation to those expectations as defined by 11 performance areas. The results of a survey of 238 industry supervisors were collected over a 5-year period in the departments of English and communication at a…

  1. English as a Lingua Franca: Analyzing Research Frameworks in International English, World Englishes, and ELF

    ERIC Educational Resources Information Center

    Pakir, Anne

    2009-01-01

    This paper considers the problems, the properties, and the prospects of using "English as a lingua franca" as a construct and as a reality. It will therefore focus on what is meant by the term "lingua franca", what is represented as a "lingua franca", and what the debates are about English as a lingua franca. The point of departure is Kachru's…

  2. Chemistry in the Pharmaceutical Industry

    NASA Astrophysics Data System (ADS)

    Poindexter, Graham S.; Pendri, Yadagiri; Snyder, Lawrence B.; Yevich, Joseph P.; Deshpande, Milind

    This chapter will discuss the role of chemistry within the pharmaceutical industry. Although the focus will be upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first world nations such as Japan and those in Europe. The major objective of the pharmaceutical industry is the discovery, development, and marketing of efficacious and safe drugs for the treatment of human disease. Of course drug companies do not exist as altruistic, charitable organizations but like other share-holder owned corporations within our capitalistic society must achieve profits in order to remain viable and competitive. Thus, there exists a conundrum between the dual goals of enhancing the quality and duration of human life and that of increasing stock-holder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships this places upon the elderly and others of limited income.

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

    ERIC Educational Resources Information Center

    Wu, Chia-Pei; Lin, Huey-Ju

    2016-01-01

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

  4. 78 FR 78275 - Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2014

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    .... SUMMARY: According to data from FRA's Management Information System, the rail industry's random drug... determination is effective December 26, 2013. FOR FURTHER INFORMATION CONTACT: Jerry Powers, FRA Drug...

  5. Drug Debacle.

    PubMed

    Sorrel, Amy Lynn

    2016-01-01

    Medicaid's Vendor Drug Program is under examination by the Texas Legislature. TMA's Physicians Medicaid Congress is seizing the opportunity to call for an administrative overhaul of a drug benefit physicians describe as unnecessarily complicated and confusing. PMID:27441421

  6. Drug Debacle.

    PubMed

    Sorrel, Amy Lynn

    2016-07-01

    Medicaid's Vendor Drug Program is under examination by the Texas Legislature. TMA's Physicians Medicaid Congress is seizing the opportunity to call for an administrative overhaul of a drug benefit physicians describe as unnecessarily complicated and confusing.

  7. Drugged Driving

    MedlinePlus

    ... Infographics » Drugged Driving Drugged Driving Email Facebook Twitter Text Description of Infographic Top Right Figure : In 2009, ... crash than those who don't smoke. Bottom Text: Develop Social Strategies Offer to be a designated ...

  8. Drug Control

    ERIC Educational Resources Information Center

    Leviton, Harvey S.

    1975-01-01

    This article attempts to assemble pertinent information about the drug problem, particularily marihuana. It also focuses on the need for an educational program for drug control with the public schools as the main arena. (Author/HMV)

  9. Generic Drugs

    MedlinePlus

    ... drugs. There are a few other differences— like color, shape, size, or taste—but they do not ... different . Brand-name drugs are often advertised by color and shape. Remember the ads for the “purple ...

  10. English Teachers' Journal (Israel), No. 17.

    ERIC Educational Resources Information Center

    Ministry of Education and Culture, Jerusalem (Israel).

    This journal, published in Israel, contains articles of interest to teachers of English as a second language, particularly those in Hebrew-English situations. This issue contains the following articles: (1) "Evaluating the Teacher's 'Control of English'," by R. Gefen; (2) "Instructional Television and the English Proficiency Level of Ninth Grade…

  11. Negotiated Syllabus in EAP Business English Courses.

    ERIC Educational Resources Information Center

    Boyle, Erlinda R.

    Negotiation of syllabus design and content in college-level business English is discussed, looking at three types: negotiation between teachers of business English, between teachers and students of business English, and between business English and content-area business teachers. Examples of practice from the Chinese University of Hong Kong are…

  12. British Support for English Studies in Europe.

    ERIC Educational Resources Information Center

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

    This survey attempts to document British support for English Studies in Europe. "English Studies" is interpreted as covering English language, British literature in English, and appropriate background studies. The first part consists of short descriptions of the activities of the principal organizations active in this field: Association of…

  13. Instructional Services for Limited English Proficient Children.

    ERIC Educational Resources Information Center

    O'Malley, J. Michael

    1982-01-01

    The 1978 Children's English and Services Study (United States) contains five findings for limited English proficient children aged 5-14, e.g., one-third are served by bilingual education/English (second language); Federal and state support for special types of instruction are received predominantly by limited English proficient children within the…

  14. English Teaching Profile: Sabah--Malaysia.

    ERIC Educational Resources Information Center

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

    This review of the status of English language instruction in Sabah, Malaysia, provides an overview of the role of English in the society in general and outlines the status of English use and instruction in both the Chinese and government educational systems at all levels. Topics covered are: the characteristics and training of English language…

  15. Globalization and English in Chinese Higher Education

    ERIC Educational Resources Information Center

    Chang, Junyue

    2006-01-01

    This paper sets China's education of English majors within the changing global and national context. It examines the impact of accelerating globalisation and the rise of global English, the adjustment of China's English language policy, the growth of the education of English majors and the challenges faced by this sector of education. To adapt to…

  16. On the Practice Teaching of English Reading

    ERIC Educational Resources Information Center

    Gao, Yonghong

    2009-01-01

    The main task of practice teaching of English Reading is to train students' independent reading ability and good reading habits. Extra-curricular reading of English literature and English newspapers and magazines plays an active role in improving English reading ability. The principle of selecting reading materials, the scope of selection and the…

  17. English Around the World, Number 5.

    ERIC Educational Resources Information Center

    McCulloch, John I. B., Ed.

    This newsletter discusses the teaching and role of English around the world. Articles also cover English-language media in a given country, and the opportunity and need for understanding and speaking English in that country. This particular issue contains items on English-language education and use in Africa, Mexico, St. Martin, Burma, West…

  18. English Teaching Profile: Yemen Arab Republic.

    ERIC Educational Resources Information Center

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

    A description of the role and status of the English language in the Yemen Arab Republic begins with a general statement concerning the distribution of English speakers and the use of English language materials. Subsequent sections outline: (1) the use and status of English within the educational system at all levels, including teacher education;…

  19. Teaching English as an International Language

    ERIC Educational Resources Information Center

    Selvi, A. F.; Yazan, B.

    2013-01-01

    English has unquestionably become a global phenomenon, generating a fundamental discussion of EIL pedagogy for English language teaching practitioners around the world. Teaching English as an International Language captures this important moment in the history of English language teaching. Readers will find an accessible introduction to the past,…

  20. Reclassification of English Learner Students in California

    ERIC Educational Resources Information Center

    Hill, Laura E.; Weston, Margaret; Hayes, Joseph M.

    2014-01-01

    Former English Learner students who have improved their facility with English to such a degree that they have been reclassified by their school districts as fluent in the English language are among the best performing students in the state. Because these Reclassified Fluent English Proficient (RFEP) students have much better academic outcomes than…