English v. General Electric Company: The state right to regulate the nuclear energy industry affirmed - (albeit indirect)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bogdan, W.

1991-12-31

The early history of the nuclear energy industry is dominated by almost exclusive federal government control and regulation. In the broadest sense, that history remains intact. Recent Supreme Court decisions, however, indicate that states are now capable of indirect regulation of the nuclear energy industry. English v. General Electric is such an example of a judicial decision with the potential to empower states with an opportunity to indirectly regulate the nuclear energy industry.

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938] Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug Substances....'' Because of increases in the number and complexity of ANDAs and FDA's desire to standardize generic drug...

Growth in an English population from the Industrial Revolution.

PubMed

Mays, S; Brickley, M; Ives, R

2008-05-01

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

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

PubMed

Amirkia, Vafa; Heinrich, Michael

2015-01-01

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. We seek to understand this phenomenon through insights from highly experienced natural product experts in industry and academia. 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. 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. 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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938] Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances... their complexity, the FDA is considering standardizing stability testing policies by adopting...

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938] Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances... Products, Questions and Answers.'' Because of increases in the number and complexity of ANDAs and FDA's...

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

... or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI 209; Availability AGENCY: Food and Drug... availability of a draft guidance for industry (draft GFI 213) entitled ``New Animal Drugs and New Animal Drug...

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

PubMed

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

2017-01-01

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

An Assessment of Drug Testing within the Construction Industry.

ERIC Educational Resources Information Center

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

2002-01-01

Investigates the efficacy of workplace drug-testing programs in reducing injury incident rates and workers' compensation experience-rating modification factors within the construction industry. Analyses indicate that companies with drug-testing programs experienced a 51 percent reduction in incident rates within two years of implementation.…

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

PubMed

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

2014-08-01

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

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.

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

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.

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

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

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

ERIC Educational Resources Information Center

Tsui, Chia-Jung

1992-01-01

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

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

...] Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical... industry entitled ``Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for... the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages.'' In the...

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

...] Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability...) is announcing the availability of a draft guidance for industry entitled ``Self-Selection Studies for Nonprescription Drug Products.'' The draft guidance is intended to provide recommendations to industry on the...

After years of steady growth, winds of restraint blowing on prescription-drug industry.

PubMed

Robinson, A

1995-07-01

Tough fiscal times are forcing cutbaks in many areas of health care, and the prescription-drug industry is no exception. The Pharmaceutical Manufacturers Association of Canada says Canada's brand-name drug companies face two major hurdles: restricted market access, as drug formularies limit the number of new drugs, and restricted price increases, as allowed by the Patented Medicine Prices Review Board and provincial formularies. The Canadian Drug Manufacturers Association, which represents Canada's generic-drug industry, says its message to physicians is that generic products are important agents of cost control and that the health care community is more aware of this than it once was. "If you don't maximize your savings while you can," cautions the association's Brenda Drinkwalter, "you'll never be able to afford the high-priced drugs of tomorrow".

After years of steady growth, winds of restraint blowing on prescription-drug industry.

PubMed Central

Robinson, A

1995-01-01

Tough fiscal times are forcing cutbaks in many areas of health care, and the prescription-drug industry is no exception. The Pharmaceutical Manufacturers Association of Canada says Canada's brand-name drug companies face two major hurdles: restricted market access, as drug formularies limit the number of new drugs, and restricted price increases, as allowed by the Patented Medicine Prices Review Board and provincial formularies. The Canadian Drug Manufacturers Association, which represents Canada's generic-drug industry, says its message to physicians is that generic products are important agents of cost control and that the health care community is more aware of this than it once was. "If you don't maximize your savings while you can," cautions the association's Brenda Drinkwalter, "you'll never be able to afford the high-priced drugs of tomorrow". Images p86-a PMID:7796380

[Generic drugs in Brazil: impacts of public policies upon the national industry].

PubMed

Quental, Cristiane; de Abreu, Jussanã Cristina; Bomtempo, José Vitor; Gadelha, Carlos Augusto Grabois

2008-04-01

This paper echoes recent works of Abrasco, Gadelha and Guimarães emphasizing the need for a better integration between health policies and industrial development and innovation policies as the only way to keep the economic benefits generated by health expenditures in the country instead of letting them escape through imports and threaten the continuity of the social policy by growing trade deficits. Although presenting the generic drug policy as a successful case in integrating social policies aimed at a better access to quality drugs for the population with economic policies aimed at industrial development, this paper discusses the impacts and limitations of the referred policy in a dialog with Abreu's analysis of industrial competitiveness in the Brazilian generics industry.

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. Copyright © 2014 Elsevier Ltd. All rights reserved.

GPs' opinions of public and industrial information regarding drugs: a cross-sectional study

PubMed Central

2011-01-01

Background General Practitioners {GP} in Sweden prescribe more than 50% of all prescriptions. Scientific knowledge on the opinions of GPs regarding drug information has been sparse. Such knowledge could be valuable when designing evidence-based drug information to GPs. GPs' opinions on public- and industry-provided drug information are presented in this article. Methods A cross-sectional study using a questionnaire was answered by 368 GPs at 97 primary-health care centres {PHCC}. The centres were invited to participate by eight out of 29 drug and therapeutic committees {DTCs}. A multilevel model was used to analyse associations between opinions of GPs regarding drug information and whether the GPs worked in public sector or in a private enterprise, their age, sex, and work experience. PHCC and geographical area were included as random effects. Results About 85% of the GPs perceived they received too much information from the industry, that the quality of public information was high and useful, and that the main task of public authorities was to increase the GPs' knowledge of drugs. Female GPs valued information from public authorities to a much greater extent than male GPs. Out of the GPs, 93% considered the main task of the industry was to promote sales. Differences between the GPs' opinions between PHCCs were generally more visible than differences between areas. Conclusions Some kind of incentives could be considered for PHCCs that actively reduce drug promotion from the industry. That female GPs valued information from public authorities to a much greater extent than male GPs should be taken into consideration when designing evidence-based drug information from public authorities to make implementation easier. PMID:21867497

English for Tourism and Hospitality Purposes (ETP)

ERIC Educational Resources Information Center

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

2017-01-01

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

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

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-24

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-23

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

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

...] Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability...) is announcing the availability of a draft guidance for industry entitled ``Pulmonary Tuberculosis... of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the...

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

...] Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY... announcing the availability of a guidance for industry entitled ``Label Comprehension Studies for Nonprescription Drug Products.'' The guidance provides recommendations on the design of label comprehension...

A knowledge management system for new drug submission by pharma-industries.

PubMed

Pinciroli, Francesco; Mottadelli, Sara; Vinci, Maurizio; Fabbro, Luigi; Gothager, Klas

2004-01-01

The pharma-industries are facing a number of crucial business issues to improve operational excellence in product time-to-market and wide regulatory compliance. These organizations own, produce, and manipulate a lot of knowledge. The new regulations by Health Authorities (HA) to pharma-industries should make the content and format of new drug application uniform worldwide. In this paper we suggest a novel approach of a pharma-industry to capture, process, and transmit clinical data electronically. The approach begins with an analysis of the knowledge generation points, some of them being outside the company. Implementations are grounded on the use of a de facto standard platform being Microsoft, having acceptable cost levels. The proposed infrastructure is integrated into existing company environment and technological platform, minimizing cost and risks, but improving efficiency and efficacy of new drug dossier compilation.

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

PubMed

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

2018-04-01

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

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0146] Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment; Availability...). The document announced the availability of a guidance for industry entitled ``Irritable Bowel Syndrome...

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

PubMed

Sahoo, Niharika; Manchikanti, Padmavati

2011-04-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-14

...] Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological... entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This revised draft... industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This...

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

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

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…

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

PubMed Central

2017-01-01

The development of structure-guided drug discovery is a story of knowledge exchange where new ideas originate from all parts of the research ecosystem. Dorothy Crowfoot Hodgkin obtained insulin from Boots Pure Drug Company in the 1930s and insulin crystallization was optimized in the company Novo in the 1950s, allowing the structure to be determined at Oxford University. The structure of renin was developed in academia, on this occasion in London, in response to a need to develop antihypertensives in pharma. The idea of a dimeric aspartic protease came from an international academic team and was discovered in HIV; it eventually led to new HIV antivirals being developed in industry. Structure-guided fragment-based discovery was developed in large pharma and biotechs, but has been exploited in academia for the development of new inhibitors targeting protein–protein interactions and also antimicrobials to combat mycobacterial infections such as tuberculosis. These observations provide a strong argument against the so-called ‘linear model’, where ideas flow only in one direction from academic institutions to industry. Structure-guided drug discovery is a story of applications of protein crystallography and knowledge exhange between academia and industry that has led to new drug approvals for cancer and other common medical conditions by the Food and Drug Administration in the USA, as well as hope for the treatment of rare genetic diseases and infectious diseases that are a particular challenge in the developing world. PMID:28875019

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-06

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

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

...] Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims... ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With...

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

...] Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment... support the approval of drug products for the treatment of patients with rheumatoid arthritis (RA). It... Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA),'' published in...

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

... documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0558] Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1083] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco... guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked...

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

...] Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment... Administration (FDA) is announcing the availability of a guidance for industry entitled ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

...] (formerly 2003D-0571) Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls... Substance Chemistry, Manufacturing, and Controls Information.'' This guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug substances that should be...

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0590] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

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.

[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.

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0429] Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs... Action'' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act...

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

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

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

PubMed

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

2015-01-01

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

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

PubMed

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

2009-09-01

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

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

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

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0881] Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations... ``Self-Identification of Generic Drug Facilities, Sites, and Organizations.'' The document was published...

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

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

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

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

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

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

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0490] Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

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

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

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

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

Drug Facts

MedlinePlus Videos and Cool Tools

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

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.

Academic-industrial partnerships in drug discovery in the age of genomics.

PubMed

Harris, Tim; Papadopoulos, Stelios; Goldstein, David B

2015-06-01

Many US FDA-approved drugs have been developed through productive interactions between the biotechnology industry and academia. Technological breakthroughs in genomics, in particular large-scale sequencing of human genomes, is creating new opportunities to understand the biology of disease and to identify high-value targets relevant to a broad range of disorders. However, the scale of the work required to appropriately analyze large genomic and clinical data sets is challenging industry to develop a broader view of what areas of work constitute precompetitive research. Copyright © 2015 Elsevier Ltd. All rights reserved.

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. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-26

... http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsand...] (formerly 1999D-4396) Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug Administration, HHS...

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Radford, L.R.; Rankin, W.L.; Barnes, V.

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 nuclearmore » 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.« less

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

... recommendations regarding study design, study conduct, and final reporting of self-selection studies. The guidance...] Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability AGENCY... announcing the availability of a guidance for industry entitled ``Self-Selection Studies for Nonprescription...

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…

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

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

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-21

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

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…

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

...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-08

...] Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance outlines FDA...

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

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

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

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-19

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0469] Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0147] Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

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

PubMed

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

2012-07-01

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

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

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

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0140] Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May Result in a Prescription Drug Shortage; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

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

...] Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug... and FDA staff entitled ``Glass Syringes for Delivering Drug and Biological Products: Technical... supplemental data are necessary for FDA to ensure the safe and effective use of glass syringes that comply with...

75 FR 6209 - Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0410] (formerly Docket No. 2006D-0191) Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials; Availability AGENCY: Food and Drug...

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

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

Practices of excellent companies in the drug industry.

PubMed

Pringle, F; Kleiner, B H

1997-01-01

Examines excellence in three major pharmaceutical companies: Merck, Lilly, and Glaxo. Provides an overview of recent trends in the health care industry. Shows that although all three companies are facing tough competition and strict cost-containment pressures, they continue to develop innovative strategies for increasing the quality of their product offering. Analyses Merck's recent acquisition of Medco and its implications; also highlights Merck's "Vital Interests" programme. Discusses Lilly's recent purchase of PCS from McKesson Drug and Lilly's recent efforts to concentrate on its core business. Introduces Helix, Glaxo's new computer network for pharmacists and explains the benefits of this unique service, both to its users and the sponsor.

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…

Industry Perspective of Pediatric Drug Development in the United States: Involvement of the European Union Countries.

PubMed

Onishi, Taku; Tsukamoto, Katsura; Matsumaru, Naoki; Waki, Takashi

2018-01-01

Efforts to promote the development of pediatric pharmacotherapy include regulatory frameworks and close collaboration between the US Food and Drug Administration and the European Medicines Agency. We characterized the current status of pediatric clinical trials conducted in the United States by the pharmaceutical industry, focusing on the involvement of the European Union member countries, to clarify the industry perspective. Data on US pediatric clinical trials were obtained from ClinicalTrials.gov . Binary regression analysis was performed to identify what factors influence the likelihood of involvement of European Union countries. A total of 633 US pediatric clinical trials that met inclusion criteria were extracted and surveyed. Of these, 206 (32.5%) involved a European Union country site(s). The results of binary regression analysis indicated that attribution of industry, phase, disease area, and age of pediatric participants influenced the likelihood of the involvement of European Union countries in US pediatric clinical trials. Relatively complicated or large pediatric clinical trials, such as phase II and III trials and those that included a broad age range of participants, had a significantly greater likelihood of the involvement of European Union countries ( P < .05). Our results suggest that (1) the pharmaceutical industry utilizes regulatory frameworks in making business decisions regarding pediatric clinical trials, (2) disease area affects the involvement of European Union countries, and (3) feasibility of clinical trials is mainly concerned by pharmaceutical industry for pediatric drug development. Additional incentives for high marketability may further motivate pharmaceutical industry to develop pediatric drugs.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0147] Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Availability AGENCY: Food and...

Vertical Integration Heats Up in Drug Industry: Will Medication Price Hikes Cool Down as a Result?

PubMed

Barlas, Stephen

2018-01-01

Is industry consolidation a response to President Donald Trump's repeated denunciation of high drug prices and congressional hearings on the issue? The author considers whether any of this corporate collaboration will get at some of the significant, underlying problems in the drug-pricing space.

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

PubMed

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

2017-01-10

Alzheimer's disease (AD) is a neurodegenerative disease with high prevalence in the rapidly growing elderly population in the developing world. The currently FDA approved drugs for the management of symptomatology of AD are marketed mainly as conventional oral medications. Due to their gastrointestinal side effects and lack of brain targeting, these drugs and dosage regiments hinder patient compliance and lead to treatment discontinuation. Nanotechnology-based drug delivery systems (NTDDS) administered by different routes can be considered as promising tools to improve patient compliance and achieve better therapeutic outcomes. Despite extensive research, literature screening revealed that clinical activities involving NTDDS application in research for AD are lagging compared to NTDDS for other diseases such as cancers. The industrial perspectives, processability, and cost/benefit ratio of using NTDDS for AD treatment are usually overlooked. Moreover, active and passive immunization against AD are by far the mostly studied alternative AD therapies because conventional oral drug therapy is not yielding satisfactorily results. NTDDS of approved drugs appear promising to transform this research from 'paper to clinic' and raise hope for AD sufferers and their caretakers. This review summarizes the recent studies conducted on NTDDS for AD treatment, with a primary focus on the industrial perspectives and processability. Additionally, it highlights the ongoing clinical trials for AD management. Copyright © 2016 Elsevier B.V. All rights reserved.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-31

... sign or symptom recurrence. The section on trial endpoints was modified to note that a drug can be...] Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment; Availability...: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

... noninferiority (NI) clinical trial designs to evaluate antibacterial drug products. The Agency's thinking in this...-controlled trials designed to show NI as the basis for approval of antibacterial drug products. This guidance... to inform industry, sponsors, applicants, researchers, and the public on the appropriate uses of NI...

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data; Availability AGENCY: Food and Drug Administration...

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

ERIC Educational Resources Information Center

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

2016-01-01

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

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

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.

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, that...

The Politics of Access to Expensive Drugs: INESSS and the Innovative Pharmaceutical Industry

PubMed Central

Hughes, David

2012-01-01

The innovative pharmaceutical industry employs thousands of people in Quebec and so has the ability to exert strong political pressure; the public statements of Sanofi-Aventis concerning the provincial reimbursement of certain expensive drugs are an example. “Maintaining a dynamic biopharmaceutical industry” is one of four main axes of the drug policy of Quebec's ministry of health. However, this role of government should not take precedence over the efficient and equitable management of health resources. We defend the legitimate and responsible choice of the Institut national d'excellence en santé et en services sociaux du Québec (INESSS) to require an acceptable cost-effectiveness ratio from expensive new drugs. PMID:23634161

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…

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;…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1083] Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers... the guidance entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... method comparison section and the sample selection inclusion and exclusion criteria section. The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

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

... selection inclusion and exclusion criteria section. The revisions define and differentiate the required... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...

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

PubMed Central

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

2005-01-01

Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK. PMID:15801942

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…

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0465] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... guidance document will serve as the special control for rTMS systems. Section 513(f)(2) of the Federal Food...

Industry-Based Bilingual Vocational Training. A Directory of Industry-Based Training Programs for LEP Adults.

ERIC Educational Resources Information Center

Thomas, Robert J.; Rhodes, Paula

The purposes of this directory of existing industry-based training programs--for limited English-proficient (LEP) adults employed in those industries--are as follows: (1) to provide a sense of the types of existing industry-based programs available to LEP employees; (2) to identify programs with the potential of implementing bilingual vocational…

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.

China English and ELT for English Majors

ERIC Educational Resources Information Center

Zhang, Mingjuan

2008-01-01

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

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

... Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New... CDRH: Anastacia Bilek, Center for Devices and Radiological Health, Food and Drug Administration, 10903... PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH,'' that...

75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-12

...] Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters... a draft guidance for industry and FDA staff entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' Dear Health Care Provider (DHCP) Letters are correspondence...

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…

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

...] Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection Devices Applied... Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to... guidance, entitled ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device...

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

... public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and... assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA...). The draft guidance, when finalized, will represent the Agency's current thinking on ``Generic Drug...

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…

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

ERIC Educational Resources Information Center

Botts, M.

1980-01-01

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

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

... costs to industry. GDUFA enables FDA to assess user fees to support critical and measurable enhancements... critical and measurable enhancements to FDA's generic drugs program. GDUFA establishes fees for abbreviated... current thinking on generic drug user fee amendments of 2012. It does not create or confer any rights for...

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

PubMed

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

2007-04-01

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

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

... facilities. The draft guidance discusses the process for registration of outsourcing facilities. The draft... outsourcing facilities that will participate in the process. Estimated reporting burden until September 30...] Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-25

...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling for Human Prescription Drug and Biological Products--Implementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear; useful; informative; and to the extent possible, consistent in content and format. It will assist applicants in developing labeling for new products, revising existing labeling, and implementing the requirements on content and format of labeling for human prescription drug and biological products (71 FR 3922), which appeared in the Federal Register of January 24, 2006. The rule is commonly referred to as the ``Physician Labeling Rule'' (PLR) because it addresses prescription drug labeling that is used by prescribers and other health care practitioners.

2003 Industry Studies: Shipbuilding

DTIC Science & Technology

2003-01-01

Vessel (HSV),” Navy Warfare Development Command (undated). Online. Internet . 1 March 2003. Industrial Technology Information Services, Taiwan... Technology Information Services, “Taiwan Industrial Outlook: Shipbuilding Industry” (2001), http://www.itis.org.tw/English/n17.html. Online. Internet ...likely see similar, if not equal improvements in the yards of global competitors. Information Technology (IT) Shipbuilders are incorporating

What You Should Know about Flu Antiviral Drugs

MedlinePlus

... Other What You Should Know About Flu Antiviral Drugs Language: English (US) Español Recommend on Facebook Tweet ... used to treat flu illness. What are antiviral drugs? Antiviral drugs are prescription medicines (pills, liquid, an ...

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…

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

PubMed

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

2009-04-01

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

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,…

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

... comments on the draft guidance by March 29, 2010. ADDRESSES: Submit written requests for single copies of...] Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability AGENCY: Food and... psychoactive effects such as sedation, euphoria, or mood change. DATES: Although you can comment on any...

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

PubMed

Löfgren, Hans

2007-06-01

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

Pharmacist-industry relationships.

PubMed

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

2017-12-01

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

Orphan drugs: trends and issues in drug development.

PubMed

Rana, Proteesh; Chawla, Shalini

2018-04-12

Research in rare diseases has contributed substantially toward the current understanding in the pathophysiology of the common diseases. However, medical needs of patients with rare diseases have always been neglected by the society and pharmaceutical industries based on their small numbers and unprofitability. The Orphan Drug Act (1983) was the first serious attempt to address the unmet medical needs for patients with rare diseases and to provide impetus for the pharmaceutical industry to promote orphan drug development. The process of drug development for rare diseases is no different from common diseases but involves significant cost and infrastructure. Further, certain aspect of drug research may not be feasible for the rare diseases. The drug-approving authority must exercise their scientific judgment and ensure due flexibility while evaluating data at various stages of orphan drug development. The emergence of patent cliff combined with the government incentives led the pharmaceutical industry to realize the good commercial prospects in developing an orphan drug despite the small market size. Indeed, many drugs that were given orphan designation ended up being blockbusters. The orphan drug market is projected to reach $178 billion by 2020, and the prospects of research and development in rare diseases appears to be quite promising and rewarding.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-07

...] Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and... availability of a final guidance document entitled ``Technical Considerations for Pen, Jet, and Related... developing information to support a marketing application for a pen, jet, or related injector device intended...

[Clinical drug trials in Germany--an assessment of current status from the viewpoint of industry].

PubMed

Baumbauer, E

1996-01-01

Drug development today is a highly professional and costly affair, whereby quality and speed are decisive competitive factors in a global setting. Germany is in the process of losing its attractiveness for clinical drug research as evidenced by a significant decrease in funding of clinical drug research which at the moment amounts to about 1.5 billion DM/year. This decrease is due to an adverse environment created by a certain anxiety in public opinion regarding technological advances, an overburden of regulations, lack of an infrastructure in hospitals to work according to GCP and a regulatory agency which has to compete with momentarily more effective agencies in Europe (UK, France). A joint effort between industry and the medical profession is called for to change this situation for the better.

Drug Themes in Science Fiction. National Institute on Drug Abuse Research Issues 9.

ERIC Educational Resources Information Center

Silverberg, Robert

This booklet is part of a series most of which focus on empirical research findings and major theoretical approaches in the area of drug usage. In this volume, the author has compiled a group of English-language short stories and novels which deal with the use of mind-altering drugs, all written since 1900 and falling within the literary category…

English Verb Accuracy of Bilingual Cantonese-English Preschoolers.

PubMed

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

2017-07-26

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

Soundscape expectations of rural tourism: A comparison between Chinese and English potential tourists.

PubMed

Ren, Xinxin; Kang, Jian; Zhu, Peisheng; Wang, Shiyuan

2018-01-01

A questionnaire survey was carried out for a comparative study between Chinese and English potential tourists to examine their soundscape expectation. The results show that while both groups prefer natural sounds most, compared to the English, the Chinese expect natural, livestock, melodic sounds more, and traffic and industrial sounds less. The sound categories related to the interactions between human activities and nature play a more dominant role for the English than the Chinese, in terms of preference of sound sources. On the expectation of a holistic soundscape, function is the most important aspect for the Chinese, while that for the English is sound characteristics; the expected psychological perception for the English is associated with emotional response rather than basic ecology consciousness, as for the Chinese.

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 Docket FDA-2008-N-0041; Formerly 2008N-0004] Guidance for Industry on Acute Bacterial Otitis Media... entitled ``Acute Bacterial Otitis Media: Developing Drugs for Treatment.'' This guidance addresses FDA's... an indication for the treatment of acute bacterial otitis media (ABOM). This guidance finalizes the...

World Englishes and English-Using Communities.

ERIC Educational Resources Information Center

Kachru, Braj B.

1997-01-01

A review of literature since 1990 on world English focuses on theoretical, conceptual, descriptive, ideological, and power-related issues, including: types of diaspora; English-using communities; dynamics of those communities; monolingual paradigms and heteroglossic English forms; transcultural literary creativity; codification and authentication…

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.…

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

...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. This draft guidance is not final nor is it in effect at this time.

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

PubMed Central

Löfgren, Hans

2007-01-01

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

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…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-05

... European Protocol for the Quality Control of the Physical and Technical Aspects of Mammography Screening... entitled ``Physical Laboratory Testing, Breast Compression System'' to follow the Mammography Quality...] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

...] Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion... the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump--Premarket Notification... this issue of the Federal Register, FDA is announcing a public meeting regarding external infusion...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-10

...] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray... guidance entitled ``Pediatric Information for X-ray Imaging Device Premarket Notifications.'' This draft... premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-19

...] Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in... entitled ``Evaluation of Sex Differences in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences in medical device clinical trials, with a specific...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

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

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

...] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Implanted Blood... blood access devices may comply with the requirement of special controls for class II devices. This...

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…

Basic English Writers' Japanese-English Wordbook.

ERIC Educational Resources Information Center

Daniels, F. J.

The author of this Japanese-English wordbook suggests that it may be used by Japanese writers of English, by those translating from Japanese into English, and by learners of Japanese, in addition to its main intended uses as an aid to the preparation of teaching material and as a work of reference for teachers. A translator will need to supplement…

Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry.

PubMed

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

2018-05-01

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

Teaching English through English: Proficiency, Pedagogy and Performance

ERIC Educational Resources Information Center

Richards, Jack C.

2017-01-01

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

77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-23

...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' FDA is issuing this guidance to inform industry and Agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for artificial pancreas systems.

Standardized Test Results: An Opportunity for English Program Improvement

ERIC Educational Resources Information Center

Jiménez, Maureyra; Rodríguez, Caroll; Rey Paba, Lourdes

2017-01-01

This case study explores the relationship between the results obtained by a group of Industrial Engineering students on a national standardized English test and the impact these results had on language program improvement. The instruments used were interviews, document analysis, observations, surveys, and test results analysis. Findings indicate…

Cheminformatics in Drug Discovery, an Industrial Perspective.

PubMed

Chen, Hongming; Kogej, Thierry; Engkvist, Ola

2018-05-18

Cheminformatics has established itself as a core discipline within large scale drug discovery operations. It would be impossible to handle the amount of data generated today in a small molecule drug discovery project without persons skilled in cheminformatics. In addition, due to increased emphasis on "Big Data", machine learning and artificial intelligence, not only in the society in general, but also in drug discovery, it is expected that the cheminformatics field will be even more important in the future. Traditional areas like virtual screening, library design and high-throughput screening analysis are highlighted in this review. Applying machine learning in drug discovery is an area that has become very important. Applications of machine learning in early drug discovery has been extended from predicting ADME properties and target activity to tasks like de novo molecular design and prediction of chemical reactions. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

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)

Redefining the Role of English as a Foreign Language in the Curriculum in the Global Context

ERIC Educational Resources Information Center

Xiaohong, Zhang; Zeegers, Margaret

2010-01-01

The English language has become a global language, a development which has influenced English language teaching and learning throughout the world. This influence has occurred more impressively in China than in other parts of the world as a result of the breathtaking pace at which China has integrated with global economies. Increasing industrial,…

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…

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…

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

PubMed

Eaton, Michael A W

2012-12-28

Over the last decade the involvement of European academic scientists in the translation of Nanomedicines and Drug Delivery into useful therapeutics has been modest. Funders have become increasingly concerned and some attempts have been made in Europe to improve impact. While the consequences are minimal at present for stakeholders, the eventual impact at national and political levels could be serious and is likely to lead to reverse innovation - the import of healthcare products from developing economies - if not addressed. Some knowledge of industrial drug development is critical for innovation in this regulated sector - this information being not easily obtained outside Pharma. While peer review has failings, more important is project inception, since once started research takes on a life of its own. This paper aims to encourage healthcare researchers to take a more translational approach to selecting (applied) drug delivery projects. Copyright © 2012 Elsevier B.V. All rights reserved.

76 FR 54473 - Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-01

... (formerly Docket No. 00D-0892)] Guidance on Positron Emission Tomography Drug Applications-- Content and... the availability of a guidance for industry entitled ``PET Drug Applications--Content and Format for... guidance for industry entitled ``PET Drug Applications--Content and Format for NDAs and ANDAs.'' The...

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…

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…

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:…

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

PubMed

Garbaccio, Robert M; Parmee, Emma R

2016-01-21

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

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…

English in the Workplace: McDonald's Executive English.

ERIC Educational Resources Information Center

Pagurek, Joyce; Fitzgerald, Brigid

The McDonald's Executive English Course was developed by Carleton University's Centre for Applied Language Studies in response to a francophone supervisor's request. As a basis for course development, information was gathered on English language use on the job, the level of English proficiency needed, and the personalities, backgrounds, and goals…

ENGLISH FOR TODAY. BOOK SIX, LITERATURE IN ENGLISH.

ERIC Educational Resources Information Center

SLAGER, WILLIAM R.; AND OTHERS

THE SIXTH AND LAST VOLUME IN THE "ENGLISH FOR TODAY" SERIES, "LITERATURE IN ENGLISH" PRESENTS A WIDE RANGE OF WELL-KNOWN CONTEMPORARY WRITERS FROM THE ENGLISH-SPEAKING WORLD--ENGLAND, THE UNITED STATES, AUSTRALIA, CANADA, INDIA, IRELAND, AND SCOTLAND. THE SELECTIONS INCLUDE--(I) SHORT STORIES BY SAKI, CALLAGHAN, O'CONNOR, HEMINGWAY, JOYCE,…

21 CFR 7.59 - General industry guidance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General industry guidance. 7.59 Section 7.59 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ENFORCEMENT POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry...

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

PubMed

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

2016-01-01

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

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

ERIC Educational Resources Information Center

Chaloupka, Diana; Papierniak, Kathleen, Ed.

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

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…

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 and...

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…

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…

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

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.

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…

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…

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…

The Irish brawn drain: English League clubs and Irish footballers, 1946-1995.

PubMed

McGovern, P

2000-09-01

This paper draws on world systems and resource dependency theories to show how the changing recruitment practices of English League clubs have deepened the brawn drain from Irish football, thereby compounding its underdevelopment. An analysis of the origins, method of recruitment and destinations of Irish players (North and South) who appeared in the English League between 1946 and 1995 shows that English clubs imported large numbers of Irish players throughout the second half of the twentieth century. However, it was the inclusion of Irish teenagers within the youth policies of the largest clubs in the period after the 1970s that marked a break from the traditional pattern of buyer-supplier relations. Instead of continuing to purchase players who had established reputations within the Irish leagues, English clubs began to hire the most promising schoolboys before they joined Irish sides. As this practice spread, it eventually eliminated a valuable source of income: the selling of players to English clubs. Despite this development it would, however, be inappropriate to view the relationship between the Irish and English football industries as a simple zero sum game as Irish clubs benefit from employing highly trained young players who return home after failing to establish careers in England.

The New English.

ERIC Educational Resources Information Center

O'Donnell, John F.

1968-01-01

Traditional English curriculums are giving way to new English programs built on the foundations of research and scholarship. The "new" English, being developed by the Project English Centers throughout the country, attempts to utilize the characteristic structure of the subject to plan sequential and spiral curriculums replacing outdated…

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.

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,…

Acculturation and drug addiction stigma among Latinos and African Americans: An examination of a church-based sample

PubMed Central

Flórez, Karen R.; Derose, Kathryn Pitkin; Breslau, Joshua; Griffin, Beth Ann; Haas, Ann C.; Kanouse, David E.; Stucky, Brian D.; Williams, Malcolm V.

2015-01-01

Background Substance use patterns among Latinos likely reflect changes in attitudes resulting from acculturation, but little is known about Latinos’ attitudes regarding drug addiction. Methods We surveyed a church-based sample of Latinos and African Americans (N=1,235) about attitudes toward drug addiction and socio-demographics. Linear regression models compared Latino subgroups with African-Americans. Results In adjusted models, Latinos had significantly higher drug addiction stigma scores compared to African Americans across all subgroups (U.S.-born Latinos, β = 0.22, p<.05; foreign-born Latinos with high English proficiency, β = 0.30, p<.05; and foreign-born Latinos with low English proficiency, β =0.49, p<.001). Additionally, Latinos with low English proficiency had significantly higher mean levels of drug use stigma compared Latinos with high proficiency (both foreign-born and U.S.-born). Discussion In this church-affiliated sample, Latinos’ drug addiction stigma decreases with acculturation, but remains higher among the most acculturated Latinos compared to African-Americans. These attitudes may pose a barrier to treatment for Latino drug users. PMID:25612923

Drug interactions between common illicit drugs and prescription therapies.

PubMed

Lindsey, Wesley T; Stewart, David; Childress, Darrell

2012-07-01

The aim was to summarize the clinical literature on interactions between common illicit drugs and prescription therapies. Medline, Iowa Drug Information Service, International Pharmaceutical Abstracts, EBSCO Academic Search Premier, and Google Scholar were searched from date of origin of database to March 2011. Search terms were cocaine, marijuana, cannabis, methamphetamine, amphetamine, ecstasy, N-methyl-3,4-methylenedioxymethamphetamine, methylenedioxymethamphetamine, heroin, gamma-hydroxybutyrate, sodium oxybate, and combined with interactions, drug interactions, and drug-drug interactions. This review focuses on established clinical evidence. All applicable full-text English language articles and abstracts found were evaluated and included in the review as appropriate. The interactions of illicit drugs with prescription therapies have the ability to potentiate or attenuate the effects of both the illicit agent and/or the prescription therapeutic agent, which can lead to toxic effects or a reduction in the prescription agent's therapeutic activity. Most texts and databases focus on theoretical or probable interactions due to the kinetic properties of the drugs and do not fully explore the pharmacodynamic and clinical implications of these interactions. Clinical trials with coadministration of illicit drugs and prescription drugs are discussed along with case reports that demonstrate a potential interaction between agents. The illicit drugs discussed are cocaine, marijuana, amphetamines, methylenedioxymethamphetamine, heroin, and sodium oxybate. Although the use of illicit drugs is widespread, there are little experimental or clinical data regarding the effects of these agents on common prescription therapies. Potential drug interactions between illicit drugs and prescription drugs are described and evaluated on the Drug Interaction Probability Scale by Horn and Hansten.

A national survey of inpatient medication systems in English NHS hospitals

PubMed Central

2014-01-01

Background Systems and processes for prescribing, supplying and administering inpatient medications can have substantial impact on medication administration errors (MAEs). However, little is known about the medication systems and processes currently used within the English National Health Service (NHS). This presents a challenge for developing NHS-wide interventions to increase medication safety. We therefore conducted a cross-sectional postal census of medication systems and processes in English NHS hospitals to address this knowledge gap. Methods The chief pharmacist at each of all 165 acute NHS trusts was invited to complete a questionnaire for medical and surgical wards in their main hospital (July 2011). We report here the findings relating to medication systems and processes, based on 18 closed questions plus one open question about local medication safety initiatives. Non-respondents were posted another questionnaire (August 2011), and then emailed (October 2011). Results One hundred (61% of NHS trusts) questionnaires were returned. Most hospitals used paper-based prescribing on the majority of medical and surgical inpatient wards (87% of hospitals), patient bedside medication lockers (92%), patients’ own drugs (89%) and ‘one-stop dispensing’ medication labelled with administration instructions for use at discharge as well as during the inpatient stay (85%). Less prevalent were the use of ward pharmacy technicians (62% of hospitals) or pharmacists (58%) to order medications on the majority of wards. Only 65% of hospitals used drug trolleys; 50% used patient-specific inpatient supplies on the majority of wards. Only one hospital had a pharmacy open 24 hours, but all had access to an on-call pharmacist. None reported use of unit-dose dispensing; 7% used an electronic drug cabinet in some ward areas. Overall, 85% of hospitals had a double-checking policy for intravenous medication and 58% for other specified drugs. “Do not disturb” tabards

A national survey of inpatient medication systems in English NHS hospitals.

PubMed

McLeod, Monsey; Ahmed, Zamzam; Barber, Nick; Franklin, Bryony Dean

2014-02-27

Systems and processes for prescribing, supplying and administering inpatient medications can have substantial impact on medication administration errors (MAEs). However, little is known about the medication systems and processes currently used within the English National Health Service (NHS). This presents a challenge for developing NHS-wide interventions to increase medication safety. We therefore conducted a cross-sectional postal census of medication systems and processes in English NHS hospitals to address this knowledge gap. The chief pharmacist at each of all 165 acute NHS trusts was invited to complete a questionnaire for medical and surgical wards in their main hospital (July 2011). We report here the findings relating to medication systems and processes, based on 18 closed questions plus one open question about local medication safety initiatives. Non-respondents were posted another questionnaire (August 2011), and then emailed (October 2011). One hundred (61% of NHS trusts) questionnaires were returned. Most hospitals used paper-based prescribing on the majority of medical and surgical inpatient wards (87% of hospitals), patient bedside medication lockers (92%), patients' own drugs (89%) and 'one-stop dispensing' medication labelled with administration instructions for use at discharge as well as during the inpatient stay (85%). Less prevalent were the use of ward pharmacy technicians (62% of hospitals) or pharmacists (58%) to order medications on the majority of wards. Only 65% of hospitals used drug trolleys; 50% used patient-specific inpatient supplies on the majority of wards. Only one hospital had a pharmacy open 24 hours, but all had access to an on-call pharmacist. None reported use of unit-dose dispensing; 7% used an electronic drug cabinet in some ward areas. Overall, 85% of hospitals had a double-checking policy for intravenous medication and 58% for other specified drugs. "Do not disturb" tabards/overalls were routinely used during nurses

To Teach Standard English or World Englishes? A Balanced Approach to Instruction

ERIC Educational Resources Information Center

Farrell, Thomas S. C.; Martin, Sonia

2009-01-01

This article suggests that English language teachers should consider all varieties of English, not just British Standard English or American Standard English. In order to better prepare students for the global world, and to show them that their own English is valued, teachers can implement a balanced approach that incorporates the teaching and…

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. Copyright © 2013 Longwoods Publishing.

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

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…

English speech sound development in preschool-aged children from bilingual English-Spanish environments.

PubMed

Gildersleeve-Neumann, Christina E; Kester, Ellen S; Davis, Barbara L; Peña, Elizabeth D

2008-07-01

English speech acquisition by typically developing 3- to 4-year-old children with monolingual English was compared to English speech acquisition by typically developing 3- to 4-year-old children with bilingual English-Spanish backgrounds. We predicted that exposure to Spanish would not affect the English phonetic inventory but would increase error frequency and type in bilingual children. Single-word speech samples were collected from 33 children. Phonetically transcribed samples for the 3 groups (monolingual English children, English-Spanish bilingual children who were predominantly exposed to English, and English-Spanish bilingual children with relatively equal exposure to English and Spanish) were compared at 2 time points and for change over time for phonetic inventory, phoneme accuracy, and error pattern frequencies. Children demonstrated similar phonetic inventories. Some bilingual children produced Spanish phonemes in their English and produced few consonant cluster sequences. Bilingual children with relatively equal exposure to English and Spanish averaged more errors than did bilingual children who were predominantly exposed to English. Both bilingual groups showed higher error rates than English-only children overall, particularly for syllable-level error patterns. All language groups decreased in some error patterns, although the ones that decreased were not always the same across language groups. Some group differences of error patterns and accuracy were significant. Vowel error rates did not differ by language group. Exposure to English and Spanish may result in a higher English error rate in typically developing bilinguals, including the application of Spanish phonological properties to English. Slightly higher error rates are likely typical for bilingual preschool-aged children. Change over time at these time points for all 3 groups was similar, suggesting that all will reach an adult-like system in English with exposure and practice.

Whose English Counts? Native Speakers as English Language Learners

ERIC Educational Resources Information Center

Grill, Jennifer

2010-01-01

The author, a teacher educator, explains that because of a lack of training in language studies, many teachers do not view language as linguists do. She identifies three misconceptions (and the implications they have for English language learners) that still persist in education: Standard English is the best and most correct form of English,…

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…

English Voices in "Text-to-Speech Tools": Representation of English Users and Their Varieties from a World Englishes Perspective

ERIC Educational Resources Information Center

Karakas, Ali

2017-01-01

English has experienced grave transformations recently in terms of socio-demographic and geographical characteristics. While such transformations have resulted in diverse types of English uses and various English users, the existing ELT materials still fail to represent the global varieties and dynamic uses and users of English. Moving from a…

Trends in Modern Drug Discovery.

PubMed

Eder, Jörg; Herrling, Paul L

2016-01-01

Drugs discovered by the pharmaceutical industry over the past 100 years have dramatically changed the practice of medicine and impacted on many aspects of our culture. For many years, drug discovery was a target- and mechanism-agnostic approach that was based on ethnobotanical knowledge often fueled by serendipity. With the advent of modern molecular biology methods and based on knowledge of the human genome, drug discovery has now largely changed into a hypothesis-driven target-based approach, a development which was paralleled by significant environmental changes in the pharmaceutical industry. Laboratories became increasingly computerized and automated, and geographically dispersed research sites are now more and more clustered into large centers to capture technological and biological synergies. Today, academia, the regulatory agencies, and the pharmaceutical industry all contribute to drug discovery, and, in order to translate the basic science into new medical treatments for unmet medical needs, pharmaceutical companies have to have a critical mass of excellent scientists working in many therapeutic fields, disciplines, and technologies. The imperative for the pharmaceutical industry to discover breakthrough medicines is matched by the increasing numbers of first-in-class drugs approved in recent years and reflects the impact of modern drug discovery approaches, technologies, and genomics.

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

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.

A Structural History of English.

ERIC Educational Resources Information Center

Nist, John

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

Theory and Practice of Chinese-English Bilingual Teaching in Circuit Course

ERIC Educational Resources Information Center

Chen, Xiao

2008-01-01

The Chinese-English bilingual teaching in the circuit course is an important approach to foster innovational talents for the electronic industry in the new century. In this article, we analyze the background, applicability and feasibility of bilingual teaching in the course of circuit and the difficulties facing in the process of implementation.…

Read the Label. English as a Second Language Initiative. Teacher's Guide.

ERIC Educational Resources Information Center

Council on Family Health, New York, NY.

The teacher's guide was developed as part of an initiative by the Council on Family Health to encourage speakers of English as a second language (ESL) to read and understand the information on over-the-counter and prescription drugs. It contains classroom activities, handout materials, and suggestions for presenting lessons on label reading. It is…

[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

Evolution of camel CYP2E1 and its associated power of binding toxic industrial chemicals and drugs.

PubMed

Kandeel, Mahmoud; Altaher, Abdullah; Kitade, Yukio; Abdelaziz, Magdi; Alnazawi, Mohamed; Elshazli, Kamal

2016-10-01

Camels are raised in harsh desert environment for hundreds of years ago. By modernization of live and the growing industrial revolution in camels rearing areas, camels are exposed to considerable amount of chemicals, industrial waste, environmental pollutions and drugs. Furthermore, camels have unique gene evolution of some genes to withstand living in harsh environments. In this work, the camel cytochrome P450 2E1 (CYP2E1) is compromised to detect its evolution rate and its power to bind with various chemicals, protoxins, procarcinogens, industrial toxins and drugs. In comparison with human CYP2E1, camel CYP2E1 more efficiently binds to small toxins as aniline, benzene, catechol, amides, butadiene, toluene and acrylamide. Larger compounds were more preferentially bound to the human CYP2E1 in comparison with camel CYP2E1. The binding of inhalant anesthetics was almost similar in both camel and human CYP2E1 coinciding with similar anesthetic effect as well as toxicity profiles. Furthermore, evolutionary analysis indicated the high evolution rate of camel CYP2E1 in comparison with human, farm and companion animals. The evolution rate of camel CYP2E1 was among the highest evolution rate in a subset of 57 different organisms. These results indicate rapid evolution and potent toxin binding power of camel CYP2E1. Copyright © 2016. Published by Elsevier Ltd.

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

PubMed Central

2017-01-01

Abstract This review provides a comprehensive survey of proprietary drug discovery and development efforts performed by Indian companies between 1994 and mid‐2016. It is based on the identification and detailed analysis of pharmaceutical, biotechnology, and contract research companies active in proprietary new chemical entity (NCE) research and development (R&D) in India. Information on preclinical and clinical development compounds was collected by company, therapeutic indication, mode of action, target class, and development status. The analysis focuses on the overall pipeline and its evolution over two decades, contributions by type of company, therapeutic focus, attrition rates, and contribution to Western pharmaceutical pipelines through licensing agreements. This comprehensive analysis is the first of its kind, and, in our view, represents a significant contribution to the understanding of the current state of the drug discovery and development industry in India. PMID:28464443

English Speech Sound Development in Preschool-Aged Children from Bilingual English-Spanish Environments

ERIC Educational Resources Information Center

Gildersleeve-Neumann, Christina E.; Kester, Ellen S.; Davis, Barbara L.; Pena, Elizabeth D.

2008-01-01

Purpose: English speech acquisition by typically developing 3- to 4-year-old children with monolingual English was compared to English speech acquisition by typically developing 3- to 4-year-old children with bilingual English-Spanish backgrounds. We predicted that exposure to Spanish would not affect the English phonetic inventory but would…

The Processing of English Derived Words by Chinese-English Bilinguals

ERIC Educational Resources Information Center

Li, Junmin; Taft, Marcus; Xu, Joe

2017-01-01

This study examined the sensitivity of Chinese-English bilinguals to derivational word structure in English. In the first experiment, English monolinguals showed masked priming effects for prime-target pairs related both transparently (e.g., "hunter-HUNT") and opaquely (e.g., "corner-CORN") but not for those related purely in…

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…

"English for the Global": Discourses in/of English-Language Voluntourism

ERIC Educational Resources Information Center

Jakubiak, Cori

2012-01-01

Drawing upon the notion of hyperglobalism and critical perspectives on English as an international language, this study examines the ways in which English language teaching via volunteer tourism (i.e. English-language voluntourism) is represented and legitimated as an altruistic practice among organizational sponsors and in the talk of current and…

New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process.

PubMed

Huang, Shiew-Mei; Strong, John M; Zhang, Lei; Reynolds, Kellie S; Nallani, Srikanth; Temple, Robert; Abraham, Sophia; Habet, Sayed Al; Baweja, Raman K; Burckart, Gilbert J; Chung, Sang; Colangelo, Philip; Frucht, David; Green, Martin D; Hepp, Paul; Karnaukhova, Elena; Ko, Hon-Sum; Lee, Jang-Ik; Marroum, Patrick J; Norden, Janet M; Qiu, Wei; Rahman, Atiqur; Sobel, Solomon; Stifano, Toni; Thummel, Kenneth; Wei, Xiao-Xiong; Yasuda, Sally; Zheng, Jenny H; Zhao, Hong; Lesko, Lawrence J

2008-06-01

Predicting clinically significant drug interactions during drug development is a challenge for the pharmaceutical industry and regulatory agencies. Since the publication of the US Food and Drug Administration's (FDA's) first in vitro and in vivo drug interaction guidance documents in 1997 and 1999, researchers and clinicians have gained a better understanding of drug interactions. This knowledge has enabled the FDA and the industry to progress and begin to overcome these challenges. The FDA has continued its efforts to evaluate methodologies to study drug interactions and communicate recommendations regarding the conduct of drug interaction studies, particularly for CYP-based and transporter-based drug interactions, to the pharmaceutical industry. A drug interaction Web site was established to document the FDA's current understanding of drug interactions (http://www.fda.gov/cder/drug/drugInteractions/default.htm). This report provides an overview of the evolution of the drug interaction guidances, includes a synopsis of the steps taken by the FDA to revise the original drug interaction guidance documents, and summarizes and highlights updated sections in the current guidance document, Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling.

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

Remapping Englishness--the Impact of Globalization on College English Instruction in Taiwan

ERIC Educational Resources Information Center

Lee, Jade Tsui-yu

2008-01-01

The purpose of this paper is to examine the impact of globalization upon the college-level instruction of English/American literature in Taiwan. The examination will be centered upon the subject of Englishness as demonstrated in the courses of English/American Literature taught in Taiwan. By focusing on the term "Englishness," the paper…

Why Do Primary School English Teachers Decide to Teach English?

ERIC Educational Resources Information Center

Amengual-Pizarro, Marian; Garcia Laborda, Jesus

2015-01-01

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

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…

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…

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…

English in Fiji.

ERIC Educational Resources Information Center

Siegel, Jeff

1989-01-01

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

ENGLISH FOR TODAY. BOOK FIVE, LIFE IN ENGLISH-SPEAKING COUNTRIES.

ERIC Educational Resources Information Center

SLAGER, WILLIAM R.; AND OTHERS

ON AN UPPER-INTERMEDIATE TO ADVANCED LEVEL OF ENGLISH AS A FOREIGN LANGUAGE FOR SECONDARY STUDENTS, "LIFE IN ENGLISH-SPEAKING COUNTRIES" IS THE FIFTH VOLUME IN THE "ENGLISH FOR TODAY" SERIES. THE MAIN EMPHASIS IN THIS VOLUME IS THE TRANSITION FROM READING TO COMPOSITION. EACH OF THE 14 READINGS IS FOLLOWED BY INTENSIVE COMPREHENSION QUESTIONS,…

Identifying and Preventing Health Problems among Young Drug-Misusing Offenders

ERIC Educational Resources Information Center

Bennett, Trevor; Holloway, Katy

2008-01-01

Purpose: The purpose of this paper is to identify the health problems and treatment needs of drug-misusing offenders and to draw out the implications of the findings for health education and prevention. Design/methodology/approach: This analysis is based on data collected as part of the New English and Welsh Arrestee Drug Abuse Monitoring…

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

PubMed

Differding, Edmond

2017-06-07

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

Importance of Phonological and Orthographic Skills for English Reading and Spelling: A Comparison of English Monolingual and Mandarin-English Bilingual Children

ERIC Educational Resources Information Center

Yeong, Stephanie H. M.; Fletcher, Janet; Bayliss, Donna M.

2014-01-01

This cross-sectional study examines the importance of English phonological and orthographic processing skills to English word reading and spelling in 3 groups of younger (8-9 years) and older (11-12 years) children from different language backgrounds: English monolingual, English first language (L1)-Mandarin second language (L2), and Mandarin…

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…

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)

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…

Drug delivery strategies for poorly water-soluble drugs.

PubMed

Fahr, Alfred; Liu, Xiangli

2007-07-01

The drug candidates coming from combinatorial chemistry research and/or the drugs selected from biologically based high-throughput screening are quite often very lipophilic, as these drug candidates exert their pharmacological action at or in biological membranes or membrane-associated proteins. This challenges drug delivery institutions in industry or academia to develop carrier systems for the optimal oral and parenteral administration of these drugs. To mention only a few of the challenges for this class of drugs: their oral bioavailability is poor and highly variable, and carrier development for parenteral administration is faced with problems, including the massive use of surface-active excipients for solubilisation. Formulation specialists are confronted with an even higher level of difficulties when these drugs have to be delivered site specifically. This article addresses the emerging formulation designs for delivering of poorly water-soluble drugs.

On Observing World English.

ERIC Educational Resources Information Center

Urdang, Lawrence

1990-01-01

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

Chinese College Students' Views on Native English and Non-Native English in EFL Classrooms

ERIC Educational Resources Information Center

Qian, Yang; Jingxia, Liu

2016-01-01

With the development of globalization, English is clearly spoken by many more non-native than native speakers, which raises the discussion of English varieties and the debate regarding the conformity to Standard English. Although a large number of studies have shown scholars' attitudes towards native English and non-native English, little research…

A Language without Borders: English Slang and Bulgarian Learners of English

ERIC Educational Resources Information Center

Charkova, Krassimira D.

2007-01-01

This study investigated the acquisition of English slang in a foreign language context. The participants were 101 Bulgarian learners of English, 58 high school students, and 43 university students. The instrument included knowledge tests of English slang terms and questions about attitudes, sources, reasons, and methods employed in learning…

Study on Correlation of English Pronunciation Self-Concept to English Learning

ERIC Educational Resources Information Center

Tang, Xin; Zhang, Shengqi; Li, Yucong; Zhao, Miqiang

2013-01-01

English pronunciation self-concept is formed in the process of pronunciation learning, which refers to the learners' self-conception and assessment of one's English pronunciation proficiency and pronunciation (Gimson, A. C. 1980). This paper reports an investigation on 237 non-English major college students into the relationship between English…

Curriculum Guide, English as a Second Language for the Workplace, Worker Education Program.

ERIC Educational Resources Information Center

Northeastern Illinois Univ., Chicago. Chicago Teachers' Center.

This guide describes a worker-centered, holistic, English-language training program for the textile industry in Illinois, now in its fifth funding cycle. The program, which provides training to approximately 500 workers, requires cooperation among business, labor unions, and educational organizations. A 5-unit curriculum covers work issues, health…

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…

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.

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…

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.

Conversational English Program, 2.

ERIC Educational Resources Information Center

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

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

Conversational English Program, 1.

ERIC Educational Resources Information Center

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

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

The Influence of English as a Social Marker in a Migrant Community.

ERIC Educational Resources Information Center

Matus-Mendoza, Mariadelaluz

Moroleon, Guanajuato (Mexico), is an industrial city on the Mexican Plateau. People from the surrounding hamlets known as rancherias frequently seek employment in the city. However, many men with low levels of education travel to Kennett Square, Pennsylvania, to work on mushroom farms. A study explored the use of English in these two communities.…

A Comparison of English Language Acquisition Patterns in English Monolingual and Bilingual Children.

ERIC Educational Resources Information Center

Glad, Diana; And Others

English monolingual and Spanish/English bilingual children in kindergarten and first grade in 11 states were administered two tests from the EL CIRCO (CIRCUS) battery. The purpose of the study was to determine comparative acquisition of English grammar for kindergarteners and first graders and for bilingual and English monolingual children. Data…

Eye Movements when Reading Spaced and Unspaced Thai and English: A Comparison of Thai-English Bilinguals and English Monolinguals

ERIC Educational Resources Information Center

Winskel, Heather; Radach, Ralph; Luksaneeyanawin, Sudaporn

2009-01-01

The study investigated the eye movements of Thai-English bilinguals when reading both Thai and English with and without interword spaces, in comparison with English monolinguals. Thai is an alphabetic orthography without interword spaces. Participants read sentences with high and low frequency target words embedded in same sentence frames with and…

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

PubMed

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

2005-01-01

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

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…

Too Good for Drugs and Violence. What Works Clearinghouse Intervention Report

ERIC Educational Resources Information Center

What Works Clearinghouse, 2006

2006-01-01

"Too Good for Drugs and Violence" is designed to promote high school students' prosocial skills, positive character traits, and violence- and drug-free norms. The curriculum consists of 14 core lessons and an additional 12 lessons that can be infused into other subject areas (such as English, science, and social studies). Students engage…

Non-Native English Speakers and Nonstandard English: An In-Depth Investigation

ERIC Educational Resources Information Center

Polat, Brittany

2012-01-01

Given the rising prominence of nonstandard varieties of English around the world (Jenkins 2007), learners of English as a second language are increasingly called on to communicate with speakers of both native and non-native nonstandard English varieties. In many classrooms around the world, however, learners continue to be exposed only to…

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…

English Medium Instruction and Idiomaticity in English as a Lingua Franca

ERIC Educational Resources Information Center

Briggs, Jessica G.; Smith, Sarah Ashley

2017-01-01

This paper critically considers the implications of the growth of English-medium instruction (EMI) globally for idiomaticity in English as a Lingua Franca (ELF). We first make the case for idiomaticity in English in terms of its contribution to language processing and use and regarding the challenges and affordances it presents to users of English…

Orientations towards English among English-Medium Instruction Students

ERIC Educational Resources Information Center

Karakas, Ali

2015-01-01

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

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…

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.…

English Verb Accuracy of Bilingual Cantonese-English Preschoolers

ERIC Educational Resources Information Center

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

2017-01-01

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

The Cambridge History of the English Language. Volume VI: English in North America.

ERIC Educational Resources Information Center

Algeo, John, Ed.

This book is one volume in a series that examines the history of English. It traces the history of English in North America during the past 400 years, from its British background to its present position among the varieties of English used worldwide. Influences that have formed American English include political, social, and cultural changes in…

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…

Understanding Disorder Within Variation: Production of English Grammatical Forms by English Language Learners.

PubMed

Bedore, Lisa M; Peña, Elizabeth D; Anaya, Jissel B; Nieto, Ricardo; Lugo-Neris, Mirza J; Baron, Alisa

2018-04-05

This study examines English performance on a set of 11 grammatical forms in Spanish-English bilingual, school-age children in order to understand how item difficulty of grammatical constructions helps correctly classify language impairment (LI) from expected variability in second language acquisition when taking into account linguistic experience and exposure. Three hundred seventy-eight children's scores on the Bilingual English-Spanish Assessment-Middle Extension (Peña, Bedore, Gutiérrez-Clellen, Iglesias, & Goldstein, 2008) morphosyntax cloze task were analyzed by bilingual experience groups (high Spanish experience, balanced English-Spanish experience, high English experience, ability (typically developing [TD] vs. LI), and grammatical form. Classification accuracy was calculated for the forms that best differentiated TD and LI groups. Children with LI scored lower than TD children across all bilingual experience groups. There were differences by grammatical form across bilingual experience and ability groups. Children from high English experience and balanced English-Spanish experience groups could be accurately classified on the basis of all the English grammatical forms tested except for prepositions. For bilinguals with high Spanish experience, it was possible to rule out LI on the basis of grammatical production but not rule in LI. It is possible to accurately identify LI in English language learners once they use English 40% of the time or more. However, for children with high Spanish experience, more information about development and patterns of impairment is needed to positively identify LI.

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…

English Language Learners and English-Only Learners' Response to Direct Vocabulary Instruction

ERIC Educational Resources Information Center

Crevecoeur, Yvel C.; Coyne, Michael D.; McCoach, D. Betsy

2014-01-01

We examined data from an 18-week kindergarten vocabulary intervention study to determine whether treatment outcomes had differential effects that favored English language learners (ELLs) or English-only learners (EOLs) and whether the relationship between initial English general receptive vocabulary knowledge and response to vocabulary…

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)

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. Copyright © 2012 Elsevier Ltd. All rights reserved.

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.

Industrial College of the Armed Forces Industry Studies 2003: Biotechnology

DTIC Science & Technology

2003-01-01

modern life. This critical sector of United States industry is developing products that will improve health care, agriculture , industrial processes...vaccines, antibiotics, drug therapies, and new medical devices. Agricultural advances include crops engineered to be pest resistant, to survive...pharmaceutical and agriculture sectors of the U.S. economy. As we enter the “Era of the Biomolecule,” the United States must implement policies and allocate

The Negro in the Drugstore Industry. The Racial Policies of American Industry.

ERIC Educational Resources Information Center

Fletcher, F. Marion; Keeney, Marie R.

This study examines the historical and current levels of Negro employment in drugstores, the reasons for the employment patterns, the prospects for greater Negro employment in high status jobs, and the effects of industry employment policies on the retail drug industry employment of Negroes. The report explores the nature of the retail drug…

English Speech Acquisition in 3- to 5-Year-Old Children Learning Russian and English

ERIC Educational Resources Information Center

Gildersleeve-Neumann, Christina E.; Wright, Kira L.

2010-01-01

Purpose: English speech acquisition in Russian-English (RE) bilingual children was investigated, exploring the effects of Russian phonetic and phonological properties on English single-word productions. Russian has more complex consonants and clusters and a smaller vowel inventory than English. Method: One hundred thirty-seven single-word samples…

Psychological Factor Affecting English Speaking Performance for the English Learners in Indonesia

ERIC Educational Resources Information Center

Haidara, Youssouf

2016-01-01

In every learning situation or environment, human psychology plays a significant role. English speaking is a language skill that is highly affected by human psychology. This research aimed at describing the psychological factor that affects negatively the English speaking performance for the English learners in Indonesia. A descriptive qualitative…

Position Paper: English Language Curriculum Guidelines for Elementary School English Language Learners

ERIC Educational Resources Information Center

Miele, Anthony

2007-01-01

English Language Development (ELD) and Academic English Development (AED) curricula in most public schools lack a communicative method and consist mostly of dry, meaningless grammar lessons devoid of relevance and authentic context. The purpose of this project is to develop guidelines to teach English language to elementary school children…

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

PubMed

Keshava, Nirmal

2017-01-01

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

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…

Drugs in sport.

PubMed

McGrath, J C; Cowan, D A

2008-06-01

This themed issue of the British Journal of Pharmacology has been compiled and edited by Ian McGrath, Regius Professor of Physiology at University of Glasgow and David Cowan, Director of the Drug Control Centre at King's College London. It contains 11 articles covering the mechanisms of action of the major groups of drugs used illicitly in sport. The articles, written by experts in how drugs work, set out where drugs can or cannot affect sporting performance, how this relates to their legitimate medicinal use, their other detrimental effects and how they can be detected. Publication coincides with Olympic year, when sport is highlighted in the public mind and much speculation is made concerning the use of drugs. The articles provide a framework of expert, accurate knowledge to inform and facilitate these debates and to help to overcome the ill-informed and dangerous anecdotal information by which sports men and women are persuaded to misuse drugs in the mistaken belief that this will improve their performance without present or future ill effects. A unique article is included by the Spedding brothers, Mike with a long career in drug discovery and Charlie, the 1984 Los Angeles Olympic Marathon Bronze Medallist and still the English National Marathon record holder. From their unique experience, they describe the insidious and unfair way that drug-assisted performance undermines the ethos of sport and endangers the vital place of sport in maintaining the health of the population.

Industry sponsorship and research outcome.

PubMed

Lundh, Andreas; Sismondo, Sergio; Lexchin, Joel; Busuioc, Octavian A; Bero, Lisa

2012-12-12

Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical industry sponsored studies are more often favorable to the sponsor's product compared with studies with other sources of sponsorship. This review is an update using more stringent methodology and also investigating sponsorship of device studies. To investigate whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship. We searched MEDLINE (1948 to September 2010), EMBASE (1980 to September 2010), the Cochrane Methodology Register (Issue 4, 2010) and Web of Science (August 2011). In addition, we searched reference lists of included papers, previous systematic reviews and author files. Cross-sectional studies, cohort studies, systematic reviews and meta-analyses that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. We had no language restrictions. Two assessors identified potentially relevant papers, and a decision about final inclusion was made by all authors. Two assessors extracted data, and we contacted authors of included papers for additional unpublished data. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether the conclusions agreed with the study results. Two assessors assessed risk of bias of included papers. We calculated pooled risk ratios (RR) for dichotomous data (with 95% confidence intervals). Forty-eight papers were included. Industry sponsored studies more often had favorable efficacy results, risk ratio (RR): 1.24 (95% confidence interval (CI): 1.14 to 1.35), harms results RR: 1.87 (95% CI: 1.54 to 2.27) and conclusions RR: 1.31 (95% CI: 1.20 to 1.44) compared with non-industry sponsored studies. Ten papers

Industry sponsorship and research outcome.

PubMed

Lundh, Andreas; Lexchin, Joel; Mintzes, Barbara; Schroll, Jeppe B; Bero, Lisa

2017-02-16

Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical-industry sponsored studies are more often favorable to the sponsor's product compared with studies with other sources of sponsorship. A similar association between sponsorship and outcomes have been found for device studies, but the body of evidence is not as strong as for sponsorship of drug studies. This review is an update of a previous Cochrane review and includes empirical studies on the association between sponsorship and research outcome. To investigate whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship. In this update we searched MEDLINE (2010 to February 2015), Embase (2010 to February 2015), the Cochrane Methodology Register (2015, Issue 2) and Web of Science (June 2015). In addition, we searched reference lists of included papers, previous systematic reviews and author files. Cross-sectional studies, cohort studies, systematic reviews and meta-analyses that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. We had no language restrictions. Two assessors screened abstracts and identified and included relevant papers. Two assessors extracted data, and we contacted authors of included papers for additional unpublished data. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether the conclusions agreed with the study results. Two assessors assessed risk of bias of included papers. We calculated pooled risk ratios (RR) for dichotomous data (with 95% confidence intervals (CIs)). Twenty-seven new papers were included in this update and in total the review contains 75 included papers. Industry sponsored studies more often

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…

English and Tok Pisin (New Guinea Pidgin English) in Papua New Guinea.

ERIC Educational Resources Information Center

Romaine, Suzanne

1989-01-01

Tok Pisin, New Guinea Pidgin English, is becoming increasingly important as a "lingua franca" in Papua New Guinea, even though English is the country's official language. Urban versus rural and spoken versus written varieties of the pidgin are examined, and the influence of English on Tok Pisin is investigated. 73 references. (Author/CB)

Is Overall Oral English Ability Related to Young Latinos' English Reading Growth?

ERIC Educational Resources Information Center

Fitzgerald, Jill; Amendum, Steven J.; Relyea, Jackie Eunjung; Garcia, Sandra G.

2015-01-01

The present study investigated whether young Latino dual-language learners' 2-year English reading growth varied over time according to their initial overall oral English ability. We followed 41 Latino children for 2 years. We tested overall oral English at the beginning of the study and administered multiple curriculum-based reading assessments…

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

ERIC Educational Resources Information Center

Doecke, Brenton

2002-01-01

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

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

PubMed

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

2004-07-01

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

Online English Learning Using Internet for English-as-a-Foreign-Language Students.

ERIC Educational Resources Information Center

Wang, Lih-Ching Chen; Dalton, David W.

Learning to communicate in English is an essential tool to access many resources via worldwide networks in the global society. Like students from many other countries, students in Taiwan study English for years, but lack opportunities to practice. For English-as-a-Second-Language students, the World Wide Web provides a learning environment in…

An Analysis of English Language Education and Its Impact on Business Practice in Taiwan.

ERIC Educational Resources Information Center

Du-Babcock, Bertha; Babcock, Richard D.

The state of English language instruction in Taiwan and its impact on firms doing business there are examined. The analysis draws on case studies of language training and use in four national and multinational corporations, each representing different nationalities and a different industry: Texas Instruments, Kaohsiung Monomer Company Limited,…

World Englishes, English as a Lingua Franca, and Intelligibility

ERIC Educational Resources Information Center

Berns, Margie

2008-01-01

This paper tests claims concerning the English as Lingua Franca (ELF) movement's position within the world Englishes paradigm. To do so, it considers the writings of Jennifer Jenkins, a leader in this movement, on what she calls "phonological intelligibility", and the writings of Larry Smith, an established scholar on intelligibility in…

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…

21 CFR 178.3520 - Industrial starch-modified.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Industrial starch-modified. 178.3520 Section 178... SANITIZERS Certain Adjuvants and Production Aids § 178.3520 Industrial starch-modified. Industrial starch... provisions of this section. (a) Industrial starch-modified is identified as follows: (1) A food starch...

21 CFR 178.3520 - Industrial starch-modified.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Industrial starch-modified. 178.3520 Section 178... SANITIZERS Certain Adjuvants and Production Aids § 178.3520 Industrial starch-modified. Industrial starch... provisions of this section. (a) Industrial starch-modified is identified as follows: (1) A food starch...

Effect of drug law enforcement on drug market violence: a systematic review.

PubMed

Werb, Dan; Rowell, Greg; Guyatt, Gordon; Kerr, Thomas; Montaner, Julio; Wood, Evan

2011-03-01

Violence is amongst the primary concerns of communities around the world and research has demonstrated links between violence and the illicit drug trade, particularly in urban settings. Given the growing emphasis on evidence-based policy-making, and the ongoing severe drug market violence in Mexico and other settings, we conducted a systematic review to examine the impacts of drug law enforcement on drug market violence. We conducted a systematic review using Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines. Specifically, we undertook a search of English language electronic databases (Academic Search Complete, PubMed, PsycINFO, EMBASE, Web of Science, Sociological Abstracts, Social Service Abstracts, PAIS International and Lexis-Nexis), the Internet (Google, Google Scholar), and article reference lists, from database inception to January 24, 2011. Overall, 15 studies were identified that evaluated the impact of drug law enforcement on drug market violence, including 11 (73%) longitudinal analyses using linear regression, 2 (13%) mathematical drug market models, and 2 (13%) qualitative studies. Fourteen (93%) studies reported an adverse impact of drug law enforcement on levels of violence. Ten of the 11 (91%) studies employing longitudinal qualitative analyses found a significant association between drug law enforcement and drug market violence. Our findings suggest that increasing drug law enforcement is unlikely to reduce drug market violence. Instead, the existing evidence base suggests that gun violence and high homicide rates may be an inevitable consequence of drug prohibition and that disrupting drug markets can paradoxically increase violence. In this context, and since drug prohibition has not meaningfully reduced drug supply, alternative regulatory models will be required if drug supply and drug market violence are to be meaningfully reduced. Copyright © 2011 Elsevier B.V. All rights reserved.

Student Editing Internships in Low-Industry Geographical Areas.

ERIC Educational Resources Information Center

Young, Gene

Morehead State University's technical writing internship program provides students who are not suited to larger, industry-based writing internship programs with professional writing experience. Most interns are English majors, and only the best and most interested students are selected. The program confers 3-6 semester hours' credit and aims to…

Collaboration between industry and academia--prospects for male fertility control.

PubMed

Stock, G; Habenicht, U F

1999-12-01

Drug development within the pharmaceutical industry is probably the field with the highest level of regulations. Due to the complexity of the different components of drug development and drug surveillance the need for a sophisticated organization and infrastructure is obvious. In addition, there is a necessity for sufficient resources and long-term commitment as well as logistic and long-term knowledge management. In order to secure high professional standards at all levels of this highly complex value creating chain, the number of cooperative arrangements in the pharmaceutical industry are increasing. The identification of new targets in the drug finding process calls in particular for outside partners. At the same time the preparedness of non-industrial researchers to cooperate with industry has also increased significantly. The area of fertility control, especially male fertility control, provides an excellent example for this kind of cooperation between industrial and non-industrial partners. Here a cooperative network is described which probably meets practically all relevant criteria for both the non-industrial but also the industrial partner. Some principles for the management of such a cooperative network are discussed. We believe that this kind of network can serve as a model for similar networks in other fields.

English Language Teaching Profile: Saudi Arabia.

ERIC Educational Resources Information Center

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

The role and status of English in Saudi Arabia are examined, with attention directed to: (1) English within the education system; (2) teachers of English; (3) English outside the education system; (4) materials support; (5) British support for the teaching of English; and (6) English syllabi at intermediate, secondary, and higher education levels.…

Prevalence and risk factors of work-related musculoskeletal disorders in the catering industry: a systematic review.

PubMed

Xu, Yan-Wen; Cheng, Andy S K; Li-Tsang, Cecilia W P

2013-01-01

This paper aims to systematically explore the prevalence and risk factors of Work-related Musculoskeletal Disorders (WMSDs) in the catering industry by reviewing relevant published literature with the goal of developing future prevention strategies. The systematic review was carried out in nine English medical databases, two Chinese-dominated full-text databases and seven web sites with the designated search strategies. Studies were included if they met the defined inclusion criteria hierarchically to investigate prevalence and or risk factors associated with WMSDs in the catering industry with appropriate epidemiological methodology. Nine English databases yielded 634 citations, and two Chinese databases yielded 401 citations, although only five English and three Chinese studies passed the inclusion criteria. Three-fourths of the studies were cross-sectional. The prevalence of WMSDs varied from 3% to 86% depending on the type of establishment and positions. The most important risk factors were physical job demands, such as work posture, force applied, and repeated movement. The lack of epidemiological information about WMSDs in the catering industry is apparent. Further studies are needed to investigate the relation among prevalence, risk factors and forms of WMSDs, in particular the interaction of risk factors in psychosocial aspects of the catering industry.

Predictors and Outcomes of Early vs. Later English Language Proficiency Among English Language Learners

PubMed Central

Halle, Tamara; Hair, Elizabeth; Wandner, Laura; McNamara, Michelle; Chien, Nina

2011-01-01

The development of English language learners (ELLs) was explored from kindergarten through eighth grade within a nationally representative sample of first-time kindergartners (N = 19,890). Growth curve analyses indicated that, compared to native English speakers, ELLs were rated by teachers more favorably on approaches to learning, self control, and externalizing behaviors in kindergarten and generally continued to grow in a positive direction on these social/behavioral outcomes at a steeper rate compared to their native English-speaking peers, holding other factors constant. Differences in reading and math achievement between ELLs and native English speakers varied based on the grade at which English proficiency is attained. Specifically, ELLs who were proficient in English by kindergarten entry kept pace with native English speakers in both reading and math initially and over time; ELLs who were proficient by first grade had modest gaps in reading and math achievement compared to native English speakers that closed narrowly or persisted over time; and ELLs who were not proficient by first grade had the largest initial gaps in reading and math achievement compared to native speakers but the gap narrowed over time in reading and grew over time in math. Among those whose home language is not English, acquiring English proficiency by kindergarten entry was associated with better cognitive and behavioral outcomes through eighth grade compared to taking longer to achieve proficiency. Multinomial regression analyses indicated that child, family, and school characteristics predict achieving English proficiency by kindergarten entry compared to achieving proficiency later. Results are discussed in terms of policies and practices that can support ELL children’s growth and development. PMID:22389551

INTERNATIONAL ENGLISH MANUAL

DOE Office of Scientific and Technical Information (OSTI.GOV)

AMADOR, MABLE; KELLER, YVONNE KELLER

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.

Tone matters for Cantonese-English bilingual children's English word reading development: A unified model of phonological transfer.

PubMed

Tong, Xiuli; He, Xinjie; Deacon, S Hélène

2017-02-01

Languages differ considerably in how they use prosodic features, or variations in pitch, duration, and intensity, to distinguish one word from another. Prosodic features include lexical tone in Chinese and lexical stress in English. Recent cross-sectional studies show a surprising result that Mandarin Chinese tone sensitivity is related to Mandarin-English bilingual children's English word reading. This study explores the mechanism underlying this relation by testing two explanations of these effects: the prosodic hypothesis and segmental phonological awareness transfer. We administered multiple measures of Cantonese tone sensitivity, English stress sensitivity, segmental phonological awareness in Cantonese and English, nonverbal ability, and English word reading to 123 Cantonese-English bilingual children ages 7 and 8 years. Structural equation modeling revealed a longitudinal prediction of Cantonese tone sensitivity to English word reading between 8 and 9 years of age. This relation was realized through two parallel routes. In one, Cantonese tone sensitivity predicted English stress sensitivity, and English stress sensitivity, in turn, significantly predicted English word reading, as postulated by the prosodic hypothesis. In the second, Cantonese tone sensitivity predicted English word reading through the transfer of segmental phonological awareness between Cantonese and English, as predicted by segmental phonological transfer. These results support a unified model of phonological transfer, emphasizing the role of tone in English word reading for Cantonese-English bilingual children.

Language Growth in English Monolingual and Spanish-English Bilingual Children from 2.5 to 5 Years.

PubMed

Hoff, Erika; Ribot, Krystal M

2017-11-01

To describe the trajectories of English and Spanish language growth in typically developing children from bilingual homes and compare those with the trajectories of English growth in children from monolingual homes, to assess effects of dual language exposure on language growth in typically developing children. Expressive vocabularies were assessed at 6-month intervals from age 30 to 60 months, in English for monolinguals and English and Spanish for bilinguals. Use of English and Spanish in the home was assessed via parental report. Multilevel modeling, including parent education as a covariate, revealed that children from bilingual homes lagged 6 months to 1 year behind monolingual children in English vocabulary growth. The size of the lag was related to the relative amount of English use in the home, but the relation was not linear. Increments in English use conferred the greatest benefit most among homes with already high levels of English use. These homes also were likely to have 1 parent who was a native English speaker. Bilingual children showed stronger growth in English than in Spanish. Bilingual children can lag 6 months to 1 year behind monolingual children in normal English language development. Such lags may not necessarily signify clinically relevant delay if parents report that children also have skills in the home language. Shorter lags are associated with 2 correlated factors: more English exposure and more exposure from native English speakers. Early exposure to Spanish in the home does not guarantee acquisition of Spanish. Copyright © 2017 Elsevier Inc. All rights reserved.

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

... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver... for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1566...

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…

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…

The Ideological Construction of English: A Critical Review on the Discourse of English in East Asia

ERIC Educational Resources Information Center

Lin, Han-Yi

2014-01-01

This research investigates the ideological character of the English language in East Asia. It focuses on the prevailing beliefs, values and propositions relating to English as a global language and the spread of English in the non-English East Asian countries, namely China, Japan, South Korea and Taiwan. By analyzing how English is presented in…

English as Cultural Action.

ERIC Educational Resources Information Center

Prodromou, Luke

1988-01-01

Discusses teaching and learning English as a foreign language in its cultural context, and the culture of the native speaker of English and its relation to the culture of the learner. Native-speaking teachers should recognize the international status of English and work from local varieties of the language. (Author/LMO)

21 CFR 178.3520 - Industrial starch-modified.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Industrial starch-modified. 178.3520 Section 178... § 178.3520 Industrial starch-modified. Industrial starch-modified may be safely used as a component of..., transporting, or holding food, subject to the provisions of this section. (a) Industrial starch-modified is...

English Proficiency and Admission and Graduation of Post-Secondary Students at a Puerto Rican University

ERIC Educational Resources Information Center

Alea, Jamie

2009-01-01

This dissertation has examined English proficiency as a mediating social factor within the occupational structure of Puerto Rico. It included an analysis of the educational records of 641 students majoring in industrial engineering, nursing, education and finance of the University of Puerto Rico, Mayaguez from 1998-2000. The investigation…

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…

An Introduction to Liberian English.

ERIC Educational Resources Information Center

Singler, John Victor; And Others

The aim of this text is to introduce Liberian English, which includes the many varieties of English spoken by Liberians, to Peace Corps volunteers. The text is divided into two sections. The first part talks about Liberian English, while the second part uses Liberian English to describe aspects of contemporary Liberian culture. Part one contains…

English Teaching Profile: Colombia.

ERIC Educational Resources Information Center

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

A review of the status of English language instruction in Colombia provides 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, postsecondary, and teacher education). The following topics are covered: the characteristics…

English Teaching in Mexico.

ERIC Educational Resources Information Center

Salazar, Denise

2002-01-01

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

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…

Effective instruction for English learners.

PubMed

Calderón, Margarita; Slavin, Robert; Sánchez, Marta

2011-01-01

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

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)

English Language Teaching Profile: Sweden.

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 Sweden discusses the role of English within Swedish society and within the Swedish educational system. The status of English as the principal foreign language since 1945 for use in business, the media and tourism is pointed out. The system of English instruction in the…

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…

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…

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,…

Industrial Arts Safety Guide. Thai. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practices in both English and Thai. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Japanese. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practice in both English and Japanese. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Cambodian. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide includes guidelines for developing a student safety program and three sections of shop safety practices in both English and Cambodian. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Korean. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practices in both English and Korean. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Ilokano. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practices in both English and Ilokano. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Chinese. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practices in both English and Chinese. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industry-Education Collaboration for Special Needs Youth and Adults.

ERIC Educational Resources Information Center

Phelps, L. Allen; Treichel, Janet

This publication examines seven programs that emphasize industrial and educational collaboration for special needs youth and adults in Illinois. The programs use various strategies to help persons with special needs, such as disadvantaged, handicapped, and limited-English-proficient persons, to prepare for the economic and employment mainstream.…

Characteristics of clinical trials that require participants to be fluent in English

PubMed Central

Egleston, Brian L; Pedraza, Omar; Wong, Yu-Ning; Dunbrack, Roland L; Griffin, Candace L; Ross, Eric A; Beck, J Robert

2015-01-01

Background/Aims Diverse samples in clinical trials can make findings more generalizable. We sought to characterize the prevalence of clinical trials in the United States that required English fluency for participants to enroll in the trial. Methods We randomly chose over 10,000 clinical trial protocols registered with ClinicalTrials.gov and examined the inclusion and exclusion criteria of the trials. We compared the relationship of clinical trial characteristics with English fluency inclusion requirements. We merged the ClinicalTrials.gov data with U.S. Census and American Community Survey data to investigate the association of English language restrictions with ZIP-code level demographic characteristics of participating institutions. We used Chi-squared tests, t-tests, and logistic regression models for analyses. Results English fluency requirements have been increasing over time, from 1.7% of trials having such requirements before 2000 to 9.0% after 2010 (p<0.001 from Chi-squared test). Industry sponsored trials had low rates of English fluency requirements (1.8%) while behavioral trials had high rates (28.4%). Trials opening in the Northeast of the U.S. had the highest regional English requirement rates (10.7%) while trials opening in more than one region had the lowest (3.3%, p<0.001). Since 1995, trials opening in ZIP-codes with larger Hispanic populations were less likely to have English fluency requirements (OR=0.92 for each 10 percent increase in proportion of Hispanics, 95% CI 0.86–0.98, p=0.013). Trials opening in ZIP-codes with more residents self-identifying as Black/African American (OR=1.87, 95% CI 1.36–2.58, p<0.001 for restricted cubic spline term) or Asian (OR=1.16 for linear term, 95% CI 1.07–1.25, p<0.001) were more likely to have English fluency requirements. ZIP-codes with higher poverty rates had trials with more English language restrictions (OR=1.06 for a 10 percent poverty rate increase, 95% CI 1.001–1.11, p=0.045). There was a

Characteristics of clinical trials that require participants to be fluent in English.

PubMed

Egleston, Brian L; Pedraza, Omar; Wong, Yu-Ning; Dunbrack, Roland L; Griffin, Candace L; Ross, Eric A; Beck, J Robert

2015-12-01

Diverse samples in clinical trials can make findings more generalizable. We sought to characterize the prevalence of clinical trials in the United States that required English fluency for participants to enroll in the trial. We randomly chose over 10,000 clinical trial protocols registered with ClinicalTrials.gov and examined the inclusion and exclusion criteria of the trials. We compared the relationship of clinical trial characteristics with English fluency inclusion requirements. We merged the ClinicalTrials.gov data with US Census and American Community Survey data to investigate the association of English-language restrictions with ZIP-code-level demographic characteristics of participating institutions. We used Chi-squared tests, t-tests, and logistic regression models for analyses. English fluency requirements have been increasing over time, from 1.7% of trials having such requirements before 2000 to 9.0% after 2010 (p < 0.001 from Chi-squared test). Industry-sponsored trials had low rates of English fluency requirements (1.8%), while behavioral trials had high rates (28.4%). Trials opening in the Northeast of the United States had the highest regional English requirement rates (10.7%), while trials opening in more than one region had the lowest (3.3%, p<0.001). Since 1995, trials opening in ZIP codes with larger Hispanic populations were less likely to have English fluency requirements (odds ratio=0.92 for each 10% increase in proportion of Hispanics, 95% confidence interval=0.86-0.98, p=0.013). Trials opening in ZIP codes with more residents self-identifying as Black/African American (odds ratio=1.87, 95% confidence interval=1.36-2.58, p<0.001 for restricted cubic spline term) or Asian (odds ratio=1.16 for linear term, 95% confidence interval=1.07-1.25, p<0.001) were more likely to have English fluency requirements. ZIP codes with higher poverty rates had trials with more English-language restrictions (odds ratio=1.06 for a 10% poverty rate increase

75 FR 59935 - Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... safety reporting for human drug products: Janet Norden, Center for Drug Evaluation and Research, Food and... for Biologics Evaluation and Research, Food and Drug Administration,1401 Rockville Pike, suite 200N..., 2003. At the request of industry, and to provide all interested persons additional time to comment, the...

Attitudes toward English & English Learning at an Iranian Military University: A Preliminary Survey

ERIC Educational Resources Information Center

Mahdavi Zafarghandi, Amir; Jodai, Hojat

2012-01-01

This study intends to represent attitudes toward English and English learning at an Iranian military university. Iranian military staff is required to study English in a social environment where there is little immediate need or opportunity to use the language for real communicative purposes.The subjects included 34 Iranian military personnel who…

English Language Proficiency and Content Assessment Performance: A Comparison of English Learners and Native English Speakers Achievement

ERIC Educational Resources Information Center

Miley, Suzi Keller; Farmer, Aarek

2017-01-01

As a result of the accountability requirements established in Title III of the Elementary and Secondary Educational Act (ESEA) legislation, English Learners (ELs) are expected to make progress in both content area academic achievement and English Language Proficiency (ELP). In Tennessee ELs progress is measured by administering WIDA-Access to…

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…

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…

English-Spanish glossary: offshore exploration and production, gas processing, and valves (in Spanish)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1981-12-01

This series of articles contains 3 different English-Spanish glossaries of related terms used in the oil industry. The glossary of the offshore exploration and production involves a summary of terms used in the offshore oil activity. It also includes names of singular equipment used in offshore drilling, as well as several navigation terms in relation to the floating oil structures. With the help of the Gas Processors Association it was possible to compile a glossary of gas processing with a concise selection of common terms of the industry of gas processing. The glossary of valves includes more than 200 termsmore » of the industry of valves in a specialized glossary, and several explanations about the application and operation of valves.« less

English-language competency of self-declared English-speaking Hispanic patients using written tests of health literacy.

PubMed Central

Zun, Leslie S.; Sadoun, Tania; Downey, LaVonne

2006-01-01

INTRODUCTION: Hispanic patients comprise the largest minority population in the United States. The federal government mandates that healthcare providers be able to communicate with those patients who have limited English ability. The primary purpose of this study was to assess the English-language proficiency of self-declared English-speaking Hispanic patients in the emergency department (ED). The secondary purpose was to determine concordance between patients' tested English proficiency and perceived proficiency by nurses and physicians. We hypothesized that many patients who state that they are able to speak English do not in fact possess sufficient ability to communicate in English. METHODS: A convenience study was conducted in an urban level-1 pediatrics and adult trauma center with 45,000 annual visits. Participants included adult patients and parents of pediatric patients, all of which spoke Spanish as their first language. Since there were no verbal tests of English-language ability used in medicine, two written tests were used as surrogates-the Rapid Estimate of Adult Literacy in Medicine (REALM) and the Short Test of Functional Health Literacy in Adults (STOFHLA). Research assistants administered these tests to patients with Hispanic surnames to assess the English comprehension of patients who stated that they spoke English. Score of seventh grade or better on the REALM and > or = 23 on the STOFHLA was considered a level of English competency. Data was entered into SPSS and analyzed for correlations. This study was approved by the institutional review board as exempt. RESULTS: Three-hundred-fifty-four patients with Hispanic names were approached and asked if they spoke English, Spanish or both. One-hundred-five patients, all self-proclaimed English speakers, were enrolled in the study. Patients ranged from 18-89 years of age, with 37.1% (39/105) male and 62.9% (66/105) and female; 49% (50/102) patients had only completed grade school. Sixty-five of 98 (66

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

PubMed

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

2013-05-01

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

In defense of industry-physician relationships.

PubMed

Nakayama, Don K

2010-09-01

The objective was to examine the economic, ethical, and legal foundations for conflict of interest restrictions between physicians and pharmaceutical and medical device industries ("industry"). Recently academic medical centers and professional organizations have adopted policies that restrict permissible interactions between industry and physicians. The motive is to avoid financial conflicts of interest that compromise core values of altruism and fiduciary relationships. Productive relationships between industry and physicians provide novel drugs and devices of immense benefit to society. The issues are opposing views of medical economics, profit motives, medical professionalism, and extent to which interactions should be lawfully restricted. Industry goals are congruent with those of physicians: patient welfare, safety, and running a profitable business. Profits are necessary to develop drugs and devices. Physician collaborators invent products, refine them, and provide feedback and so are appropriately paid. Marketing is necessary to bring approved products to patients. Economic realities limit the extent to which physicians treat their patients altruistically and as fiduciaries. Providing excellent service to patients may be a more realistic standard. Statements from industry and the American College of Surgeons appropriately guide professional behavior. Preservation of industry-physician relationships is vital to maintain medical innovation and progress.

Does Adding Mathematics to English Language Learners' Timetables Improve Their Acquisition of English?

ERIC Educational Resources Information Center

Stacey, Jenny

2016-01-01

This enquiry based project set out to find out if adult English language learners, known as ESOL (English for Speakers of Other Languages) learners in the UK, might benefit, in terms of their acquisition of English, from studying maths. This research has been conducted at a medium sized FE college in the East Midlands where I teach. I evaluate…

Teaching English or Producing Docility? Foucauldian Analysis of Pakistani State-Mandated English Textbooks

ERIC Educational Resources Information Center

Channa, Liaquat Ali; Gilhooly, Daniel; Channa, Abdul Razaque; Manan, Syed Abdul

2017-01-01

The scholarship of language education, particularly with reference to learning and use of English, is marked by varieties of English. One may note two broad models: (1) ENL, ESL, and EFL; (2) EIL, ELF, and WEs. Although the scholarship is replete with debates, the debates seem to only construct and maintain that learning English and its use are…

Reconsidering Japan's underperformance in pharmaceuticals: evidence from Japan's anticancer drug sector.

PubMed

Umemura, Maki

2010-01-01

Unlike its automobile or electronics industries, Japan's pharmaceutical industry did not become a global leader. Japan remains a net importer of pharmaceuticals and has introduced few global blockbuster drugs. Alfred Chandler argued that Japan's pharmaceutical firms remained relatively weak because Western firms enjoyed an insurmountable first first-mover advantage. However, this case study of the anticancer drug sector illustrates that Chandler's explanation is incomplete. Japanese medical culture, government policy, and research environment also played a substantial role in shaping the industry. In the 1970s and 1980s, these factors encouraged firms to develop little few effective drugs with low side effects, and profit from Japan's domestic market. But, these drugs were unsuitable to foreign markets with more demanding efficacy standards. As a result, Japan not only lost more than a decade in developing ineffective drugs, but also neglected to create the infrastructure necessary to develop innovative drugs and build a stronger pharmaceutical industry.

Business as Usual: The Use of English in the Professional World in Hong Kong

ERIC Educational Resources Information Center

Evans, Stephen

2010-01-01

This article examines the role of written and spoken English vis-a-vis written Chinese, Cantonese and Putonghua in the four key service industries that have driven Hong Kong's economy in the past decade. The study forms part of a long-standing and continuing investigation into the impact of Hong Kong's transition from British colony to Chinese…

English speech acquisition in 3- to 5-year-old children learning Russian and English.

PubMed

Gildersleeve-Neumann, Christina E; Wright, Kira L

2010-10-01

English speech acquisition in Russian-English (RE) bilingual children was investigated, exploring the effects of Russian phonetic and phonological properties on English single-word productions. Russian has more complex consonants and clusters and a smaller vowel inventory than English. One hundred thirty-seven single-word samples were phonetically transcribed from 14 RE and 28 English-only (E) children, ages 3;3 (years;months) to 5;7. Language and age differences were compared descriptively for phonetic inventories. Multivariate analyses compared phoneme accuracy and error rates between the two language groups. RE children produced Russian-influenced phones in English, including palatalized consonants and trills, and demonstrated significantly higher rates of trill substitution, final devoicing, and vowel errors than E children, suggesting Russian language effects on English. RE and E children did not differ in their overall production complexity, with similar final consonant deletion and cluster reduction error rates, similar phonetic inventories by age, and similar levels of phonetic complexity. Both older language groups were more accurate than the younger language groups. We observed effects of Russian on English speech acquisition; however, there were similarities between the RE and E children that have not been reported in previous studies of speech acquisition in bilingual children. These findings underscore the importance of knowing the phonological properties of both languages of a bilingual child in assessment.

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

PubMed

Monaghan, Mark; Yeomans, Henry

2016-11-01

Alcohol policy and illicit drugs policy are typically presented as separate and different in academic discussion. This is understandable, to a degree, as the criminal law upholds a 'great regulatory divide' (Seddon, 2010: 56) separating the licit trade in alcohol from the illicit trade in substances classified as either class A, B or C under the Misuse of Drugs Act 1971. This paper takes a different stance. In doing so, it draws upon Berridge's (2013) argument that policies governing various psychoactive substances have been converging since the mid-twentieth century and seeks to elaborate it using recent developments relating to the control and regulation of drugs and alcohol in the broader areas of criminal justice and welfare reform. Significantly, the article examines how recent policy directions relating to both drugs and alcohol in England have, under the aegis of the 'recovery agenda', been connected to a broader behavioural politics oriented towards the actions and lifestyles of an apparently problematic subgroup of the population or 'underclass'. The paper thus concludes that, although the great regulatory divide remains intact, an underclass politics is contributing towards the greater alignment of illicit drugs and alcohol policies, especially in regards to the respective significance of abstinence (or abstinence-based 'recovery'). Copyright © 2016 Elsevier B.V. All rights reserved.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-07

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

Orphan drug: Development trends and strategies

PubMed Central

Sharma, Aarti; Jacob, Abraham; Tandon, Manas; Kumar, Dushyant

2010-01-01

The growth of pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will loose their exclusivity in next 5 years. Therefore, the current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies from the essential medicines to the new business model — niche busters, also called orphan drugs. Orphan drugs may help pharma companies to reduce the impact of revenue loss caused by patent expiries of blockbuster drugs. The new business model of orphan drugs could offer an integrated healthcare solution that enables pharma companies to develop newer areas of therapeutics, diagnosis, treatment, monitoring, and patient support. Incentives for drug development provided by governments, as well as support from the FDA and EU Commission in special protocols, are a further boost for the companies developing orphan drugs. Although there may still be challenges ahead for the pharmaceutical industry, orphan drugs seem to offer the key to recovery and stability within the market. In our study, we have compared the policies and orphan drug incentives worldwide alongwith the challenges faced by the pharmaceutical companies. Recent developments are seen in orphan drug approval, the various drugs in orphan drug pipeline, and the future prospectives for orphan drugs and diseases. PMID:21180460

Characteristics of an Effective English Language Teacher as Perceived by Iranian Teachers and Learners of English

ERIC Educational Resources Information Center

Shishavan, Homa Babai; Sadeghi, Karim

2009-01-01

This study attempted to characterize qualities of an effective English language teacher (EELT) as perceived by Iranian English language teachers and learners. For this purpose, a tailor-made questionnaire was administered to 59 English language teachers and 215 learners of English at universities, high schools and language institutes in Iran. The…

Borrowing Legitimacy as English Learner (EL) Leaders: Indiana's 14-Year History with English Language Proficiency Standards

ERIC Educational Resources Information Center

Morita-Mullaney, Trish

2017-01-01

English language proficiency or English language development (ELP/D) standards guide how content-specific instruction and assessment is practiced by teachers and how English learners (ELs) at varying levels of English proficiency can perform grade-level-specific academic standards in K-12 US schools. With the transition from the state-developed…

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.

The Yale Kamusi Project: A Swahili-English, English-Swahili Dictionary.

ERIC Educational Resources Information Center

Hinnebusch, Thomas

2001-01-01

Evaluates the strengths and weaknesses of the Yale Online Kamusi project, an electronic Web-based Swahili-English and English-Swahili dictionary. The dictionary is described and checked for comprehensiveness, the adequacy and quality of the glosses and definitions are tested, and a number of recommendations are made to help make it a better and…

Which English? Whose English? An Investigation of "Non-Native" Teachers' Beliefs about Target Varieties

ERIC Educational Resources Information Center

Young, Tony Johnstone; Walsh, Steve

2010-01-01

This study explored the beliefs of "non-native English speaking" teachers about the usefulness and appropriacy of varieties such as English as an International Language (EIL) and English as a Lingua Franca (ELF), compared with native speaker varieties. The study therefore addresses the current theoretical debate concerning "appropriate" target…

Teaching colloquial Australian English to medical students from non-English speaking backgrounds.

PubMed

Chur-Hansen, A; Barrett, R J

1996-11-01

Lack of fluency in the language of instruction can form a barrier to medical education. There has been an effort within Australian universities to teach English to students from non-English speaking backgrounds (NESB), but little systematic attention has been given to the teaching of informal or colloquial English. This paper provides evidence that colloquial language is a pervasive and important aspect of doctor-patient communication. It describes a teaching project for NESB medical students which aimed to introduce them to colloquial English, and to provide them with a contextual approach to learning this form of language. Forty-four first year medical students enrolled at the University of Adelaide were required to gather examples of colloquial language by interviewing a native English speaker. Ninety-four examples of colloquial sayings were recorded. These were compiled in the form of a handbook which served as a student resource. Student evaluation of this exercise was positive. The benefits of an interactive method of teaching local and setting-specific language are discussed, and the implications of this approach for clinical teaching and for medical practice are explored.

"Under the radar": nurse practitioner prescribers and pharmaceutical industry promotions.

PubMed

Ladd, Elissa C; Mahoney, Diane Feeney; Emani, Srinivas

2010-12-01

To assess nurse practitioners' interactions with pharmaceutical industry promotional activities and their perception of information reliability and self-reported prescribing behaviors. Self-administered online survey. A nationally randomized sample of nurse practitioner prescribers was surveyed. Eligibility criteria included current clinical practice and licensure to prescribe medications in their state of practice. A total of 263 responses were analyzed. Almost all respondents (96%) reported regular contact with pharmaceutical sales representatives, and most (71%) reported receiving information on new drugs directly from pharmaceutical sales representatives some or most of the time. A large portion (66%) dispensed drug samples regularly to their patients, and 73% believed that samples were somewhat or very helpful in learning about new drugs. Eighty-one percent of respondents thought that it was ethically acceptable to give out samples to anyone, and 90% believed that it was acceptable to attend lunch and dinner events sponsored by the pharmaceutical industry. Almost half (48%) stated that they were more likely to prescribe a drug that was highlighted during a lunch or dinner event. Most respondents stated that it was ethically acceptable for speakers to be paid by industry. Nurse practitioner prescribers had extensive contact with pharmaceutical industry promotional activities such as pharmaceutical representative contact, receipt of drug samples, and regular attendance at industry-sponsored meal events and continuing education programs. They reported that industry interface with nurse practitioner prescribers in the form of sponsored meals, education events, and paid speakers was ethically acceptable.

Linguistically Directed Attention to the Temporal Aspect of Action Events in Monolingual English Speakers and Chinese-English Bilingual Speakers with Varying English Proficiency

ERIC Educational Resources Information Center

Chen, Jenn-Yeu; Su, Jui-Ju; Lee, Chao-Yang; O'Seaghdha, Padraig G.

2012-01-01

Chinese and English speakers seem to hold different conceptions of time which may be related to the different codings of time in the two languages. Employing a sentence-picture matching task, we have investigated this linguistic relativity in Chinese-English bilinguals varying in English proficiency and found that those with high proficiency…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-05

...] Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs... entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.'' The... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs...

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…

21 CFR 7.59 - General industry guidance.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false General industry guidance. 7.59 Section 7.59 Food... POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.59 General industry guidance. A recall can be disruptive of a firm's operation and business...

21 CFR 7.59 - General industry guidance.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false General industry guidance. 7.59 Section 7.59 Food... POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.59 General industry guidance. A recall can be disruptive of a firm's operation and business...

21 CFR 7.59 - General industry guidance.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false General industry guidance. 7.59 Section 7.59 Food... POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.59 General industry guidance. A recall can be disruptive of a firm's operation and business...

21 CFR 7.59 - General industry guidance.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false General industry guidance. 7.59 Section 7.59 Food... POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.59 General industry guidance. A recall can be disruptive of a firm's operation and business...

Swahili 12 Weeks Course. Volume VI, Vocabulary List: Swahili-English, English-Swahili.

ERIC Educational Resources Information Center

Defense Language Inst., Washington, DC.

This Swahili-English/English-Swahili vocabulary list accompanies the Defense Language Institute's 12-weeks course in Swahili. For a description of the first five volumes (55 lesson units), see ED 026 651. (AMM)

Regulatory Forum Opinion Piece: Review of FDA Draft Guidance Testicular Toxicity-Evaluation during Drug Development Guidance for Industry.

PubMed

Hukkanen, Renee R; Halpern, Wendy G; Vidal, Justin D

2016-10-01

In July 2015, the U.S. Food and Drug Administration (FDA) posted a new draft guidance entitled "Testicular Toxicity: Evaluation during Drug Development Guidance for Industry," with a 90-day public comment period. As the nonclinical assessment of testicular toxicity often relies on the expert interpretation of pathology affecting the male reproductive tract, this draft guidance is considered directly relevant to the toxicologic pathology community. Therefore, a working group was formed through the Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathologists (STPs) to provide a detailed review of the draft guidance. Specific comments on the guidance were submitted to the FDA by the STP. The draft guidance and all comments received are currently under review with the FDA. This commentary provides a summary of the components of the draft guidance and the comments submitted by the STP with acknowledgment of different perspectives reflected in comments from other respondents. © The Author(s) 2016.

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…

English Language Schooling, Linguistic Realities, and the Native Speaker of English in Hong Kong

ERIC Educational Resources Information Center

Hansen Edwards, Jette G.

2018-01-01

The study employs a case study approach to examine the impact of educational backgrounds on nine Hong Kong tertiary students' English and Cantonese language practices and identifications as native speakers of English and Cantonese. The study employed both survey and interview data to probe the participants' English and Cantonese language use at…

Teaching Intercultural English Learning/Teaching in World Englishes: Some Classroom Activities in South Korea

ERIC Educational Resources Information Center

Lee, Kang-Young

2012-01-01

This paper discusses what intercultural English learning/teaching (IELT) is in English as a world Englishes (WEes) and how IELT can contribute to the development of proficiency/competence among WEes and can be fitted into actual WEes classrooms. This is to claim that IELT be a pivotal contextual factor facilitating success in…

The Home Literacy Environment and the English Narrative Development of Spanish-English Bilingual Children

ERIC Educational Resources Information Center

Bitetti, Dana; Hammer, Carol Scheffner

2016-01-01

Purpose: The purpose of this study was to examine the impact of the home literacy environment (HLE) on the English narrative development of Spanish-English bilingual children from low-income backgrounds. Method: Longitudinal data were collected on 81 bilingual children from preschool through 1st grade. English narrative skills were assessed in the…

An Action Research on Improving Non-English Majors' English Writing by "Basic Sentence Pattern Translation Drills"

ERIC Educational Resources Information Center

He, Xiaoyu

2016-01-01

English writing plays an indispensible part in EFL (English as a Foreign Language) learning for Chinese students, which accounts for a high score in an English test in China. And it is also a comprehensive reflection of students' abilities in L2 application. However, most non-English majors in vocational and technical colleges have great trouble…

Stress Judgment and Production in English Derivation, and Word Reading in Adult Mandarin-Speaking English Learners.

PubMed

Chung, Wei-Lun; Jarmulowicz, Linda

2017-08-01

For monolingual English-speaking children, judgment and production of stress in derived words, including words with phonologically neutral (e.g., -ness) and non-neutral suffixes (e.g., -ity), is important to both academic vocabulary growth and to word reading. For Mandarin-speaking adult English learners (AELs) the challenge of learning the English stress system might be complicated by cross-linguistic differences in prosodic function and features. As Mandarin-speakers become more proficient in English, patterns similar to those seen in monolingual children could emerge in which awareness and use of stress and suffix cues benefit word reading. A correlational design was used to examine the contributions of English stress in derivation with neutral and non-neutral suffixes to English word and nonword reading. Stress judgment in non-neutral derivation predicted word reading after controlling for working memory and English vocabulary; whereas stress production in neutral derivation contributed to word reading and pseudoword decoding, independent of working memory and English vocabulary. Although AELs could use stress and suffix cues for word reading, AELs were different from native English speakers in awareness of non-neutral suffix cues conditioning lexical stress placement. AELs may need to rely on lexical storage of primary stress in derivations with non-neutral suffixes.

Revisiting "the origins of compulsory drug prescriptions".

PubMed Central

Marks, H M

1995-01-01

It has been argued that today's prescription drug market originated in the arbitrary acts of the US Food and Drug Administration (FDA), which in 1938 issued regulations creating a class of drugs that could be sold by prescription only. On the basis of the FDA's administrative records, I argue that the 1938 regulations on prescription drug labeling were initiated by industry and then agreed to by the FDA; that contemporaries understood and accepted the reasons for restricting the use of certain drugs; and that the subsequent evolution of these regulations is best understood as an FDA effort to limit industry abuses of the prescription labeling system. This decade-long war of position ended when drug manufacturers persuaded the US Congress to enshrine their version of prescription labeling in law in a highly politicized struggle over government's role in the economy. Images FIGURE 1 PMID:7832245

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…

Do Decision Rules Matter? A Descriptive Study of English Language Proficiency Assessment Classifications for English-Language Learners and Native English Speakers in Fifth Grade

ERIC Educational Resources Information Center

Carroll, Patricia E.; Bailey, Alison L.

2016-01-01

English language proficiency assessments (ELPA) are used in the United States to measure annually the English language progress and proficiency of English-language learners (ELLs), a subgroup of language minority students who receive language acquisition support mandated and largely funded by Title III (NCLB, 2001). ELPA proficient and…

The Effects of Industry Sponsorship on Comparator Selection in Trial Registrations for Neuropsychiatric Conditions in Children

PubMed Central

Dunn, Adam G.; Mandl, Kenneth D.; Coiera, Enrico; Bourgeois, Florence T.

2013-01-01

Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric

The effects of industry sponsorship on comparator selection in trial registrations for neuropsychiatric conditions in children.

PubMed

Dunn, Adam G; Mandl, Kenneth D; Coiera, Enrico; Bourgeois, Florence T

2013-01-01

Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric

Attitudes of Japanese Learners and Teachers of English towards Non-Standard English in Coursebooks

ERIC Educational Resources Information Center

Takahashi, Reiko

2017-01-01

Over the decades, efforts have been made to incorporate diverse perspectives on World Englishes into English Language Teaching (ELT) practice and teaching materials. To date, the majority of ELT learners and teachers have not yet been exposed to materials which use and explore non-standard forms of English. This paper examines the attitudes of…

Proposed correlation of modern processing principles for Ayurvedic herbal drug manufacturing: A systematic review.

PubMed

Jain, Rahi; Venkatasubramanian, Padma

2014-01-01

Quality Ayurvedic herbal medicines are potential, low-cost solutions for addressing contemporary healthcare needs of both Indian and global community. Correlating Ayurvedic herbal preparations with modern processing principles (MPPs) can help develop new and use appropriate technology for scaling up production of the medicines, which is necessary to meet the growing demand. Understanding the fundamental Ayurvedic principles behind formulation and processing is also important for improving the dosage forms. Even though Ayurvedic industry has adopted technologies from food, chemical and pharmaceutical industries, there is no systematic study to correlate the traditional and modern processing methods. This study is an attempt to provide a possible correlation between the Ayurvedic processing methods and MPPs. A systematic literature review was performed to identify the Ayurvedic processing methods by collecting information from English editions of classical Ayurveda texts on medicine preparation methods. Correlation between traditional and MPPs was done based on the techniques used in Ayurvedic drug processing. It was observed that in Ayurvedic medicine preparations there were two major types of processes, namely extraction, and separation. Extraction uses membrane rupturing and solute diffusion principles, while separation uses volatility, adsorption, and size-exclusion principles. The study provides systematic documentation of methods used in Ayurveda for herbal drug preparation along with its interpretation in terms of MPPs. This is the first step which can enable improving or replacing traditional techniques. New technologies or use of existing technologies can be used to improve the dosage forms and scaling up while maintaining the Ayurvedic principles similar to traditional techniques.

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,…

Reclassification Patterns among Latino English Learner Students in Bilingual, Dual Immersion, and English Immersion Classrooms

ERIC Educational Resources Information Center

Umansky, Ilana M.; Reardon, Sean F.

2014-01-01

Schools are under increasing pressure to reclassify their English learner (EL) students to "fluent English proficient" status as quickly as possible. This article examines timing to reclassification among Latino ELs in four distinct linguistic instructional environments: English immersion, transitional bilingual, maintenance bilingual,…

Harms and benefits associated with psychoactive drugs: findings of an international survey of active drug users

PubMed Central

Morgan, Celia JA; Noronha, Louise A; Muetzelfeldt, Mark; Fielding, Amanda

2013-01-01

There have been several recent efforts in the UK and the Netherlands to describe the harms of psychoactive substances based on ratings of either experts or drug users. This study aimed to assess the perceived benefits as well as harms of widely used recreational drugs, both licit and illicit, in an international sample of drug users. The survey was hosted at https://www.internationaldrugsurvey.org/ and was available in three languages. Residents reported their experience of 15 commonly used drugs or drug classes; regular users then rated their harms and benefits. In all, 5791 individuals from over 40 countries completed the survey, although the majority were from English speaking countries. Rankings of drugs differed across 10 categories of perceived benefits. Skunk and herbal cannabis were ranked consistently beneficial, whilst alcohol and tobacco fell below many classified drugs. There was no correlation at all between users’ harm ranking of drugs and their classification in schedules of the USA or ABC system in the UK. Prescription analgesics, alcohol and tobacco were ranked within the top 10 most harmful drugs. These findings suggest that neither the UK nor US classification systems act to inform users of the harms of psychoactive substances. It is hoped the results might inform health professionals and educators of what are considered to be both the harms and benefits of psychoactive substances to young people. PMID:23438502

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

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. Copyright © 2016 by The American Society for Pharmacology and Experimental Therapeutics.

The Impact of the Advent of English in Primary Schools on the Development of College English in China

ERIC Educational Resources Information Center

Liu, Jun; Dai, Zhongxin

2011-01-01

This article discusses the impact of the advent of primary English on the development of College English in China. The advent of English in primary schools as a teaching subject has brought about a downward shift of focus of the English education system in China. Basic English education will be accomplished in primary and secondary schools. The…

AMERICAN ENGLISH FOR INTERNATIONAL BUSINESSMEN.

ERIC Educational Resources Information Center

COSTINETT, SANDRA; ROSS, GORDON

DESIGNED FOR NON-ENGLISH SPEAKERS ON AN INTERMEDIATE-ADVANCED LEVEL OF ENGLISH, THIS TEXT PROVIDES FOR PRACTICE IN CONVERSATIONAL BUSINESS ENGLISH. EACH OF THE TWELVE UNITS IS BASED ON A SPECIFIC TOPIC--PHONE CALLS, TRAVEL ARRANGEMENTS, QUARTERLY REPORTS AND SALES, ORGANIZATION CHARTS, ORDERING, PLANT LAYOUT, INVESTMENTS, EMPLOYEE BENEFITS,…

Lexical Innovation in Ghanaian English.

ERIC Educational Resources Information Center

Bamiro, Edmund O.

An analysis of lexical innovation in Ghanaian English uses ten linguistic categories identified in earlier research on Nigerian English, offering an explanation of each category and a number of examples. The categories include: loanshifts (English words manipulated to produce and transmit meanings beyond purely denotative reference and conveying a…

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…

Masking Release for Igbo and English.

PubMed

Ebem, Deborah U; Desloge, Joseph G; Reed, Charlotte M; Braida, Louis D; Uguru, Joy O

2013-09-01

In this research, we explored the effect of noise interruption rate on speech intelligibility. Specifically, we used the Hearing In Noise Test (HINT) procedure with the original HINT stimuli (English) and Igbo stimuli to assess speech reception ability in interrupted noise. For a given noise level, the HINT test provides an estimate of the signal-to-noise ratio (SNR) required for 50%-correct speech intelligibility. The SNR for 50%-correct intelligibility changes depending upon the interruption rate of the noise. This phenomenon (called Masking Release) has been studied extensively in English but not for Igbo - which is an African tonal language spoken predominantly in South Eastern Nigeria. This experiment explored and compared the phenomenon of Masking Release for (i) native English speakers listening to English, (ii) native Igbo speakers listening to English, and (iii) native Igbo speakers listening to Igbo. Since Igbo is a tonal language and English is a non-tonal language, this allowed us to compare Masking Release patterns on native speakers of tonal and non-tonal languages. Our results for native English speakers listening to English HINT show that the SNR and the masking release are orderly and consistent with other English HINT data for English speakers. Our result for Igbo speakers listening to English HINT sentences show that there is greater variability in results across the different Igbo listeners than across the English listeners. This result likely reflects different levels of ability in the English language across the Igbo listeners. The masking release values in dB are less than for English listeners. Our results for Igbo speakers listening to Igbo show that in general, the SNRs for Igbo sentences are lower than for English/English and Igbo/English. This means that the Igbo listeners could understand 50% of the Igbo sentences at SNRs less than those required for English sentences by either native or non-native listeners. This result can be

The Effects of Computer Assisted English Instruction on High School Preparatory Students' Attitudes towards Computers and English

ERIC Educational Resources Information Center

Ates, Alev; Altunay, Ugur; Altun, Eralp

2006-01-01

The aim of this research was to discern the effects of computer assisted English instruction on English language preparatory students' attitudes towards computers and English in a Turkish-medium high school with an intensive English program. A quasi-experimental time series research design, also called "before-after" or "repeated…

78 FR 79700 - Request for Notification From Industry Organizations Interested in Participating in Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-31

... a Nonvoting Industry Representative on the Food Advisory Committee and Request for Nominations for a Nonvoting Industry Representative on the Food Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting that any industry...

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…

English-Russian, Russian-English glossary of coal-cleaning terms

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pekar, J.

1987-09-01

The document is an English-Russian, Russian-English glossary of coal-cleaning terms, compiled as a joint U.S./Soviet effort. The need for the glossary resulted from the growing number of language-specific terms used during information exchanges within the framework of the U.S./U.S.S.R. Working Group on Stationary Source Air Pollution Control Technology, under the U.S./U.S.S.R. Agreement of Cooperation in the Field of Environmental Protection.

Proficiency in English sentence stress production by Cantonese speakers who speak English as a second language (ESL).

PubMed

Ng, Manwa L; Chen, Yang

2011-12-01

The present study examined English sentence stress produced by native Cantonese speakers who were speaking English as a second language (ESL). Cantonese ESL speakers' proficiency in English stress production as perceived by English-speaking listeners was also studied. Acoustical parameters associated with sentence stress including fundamental frequency (F0), vowel duration, and intensity were measured from the English sentences produced by 40 Cantonese ESL speakers. Data were compared with those obtained from 40 native speakers of American English. The speech samples were also judged by eight native listeners who were native speakers of American English for placement, degree, and naturalness of stress. Results showed that Cantonese ESL speakers were able to use F0, vowel duration, and intensity to differentiate sentence stress patterns. Yet, both female and male Cantonese ESL speakers exhibited consistently higher F0 in stressed words than English speakers. Overall, Cantonese ESL speakers were found to be proficient in using duration and intensity to signal sentence stress, in a way comparable with English speakers. In addition, F0 and intensity were found to correlate closely with perceptual judgement and the degree of stress with the naturalness of stress.

Developing an English for Specific Purpose Curriculum for Asian Call Centres: How Theory Can Inform Practice

ERIC Educational Resources Information Center

Lockwood, Jane

2012-01-01

The primary focus of this article is the investigation of how current applied linguistic research into the nature of call centre communication breakdown in business processing outsourcing (BPO) sites such as India and the Philippines, can impact English communications training program content and design for this industry. It is argued that a…

Theoretical Considerations in the Measurement of the English-Language Proficiency of Limited-English-Proficient Students.

ERIC Educational Resources Information Center

Abbott, Muriel M.

Limited-English-proficient (LEP) students who are not sufficiently proficient in English to participate effectively in an English-speaking instructional environment must be identified for placement in an appropriate educational program. Their progress through an instructional program that is designed to improve their acquisition of English…

The Relationship between Cognate Awareness and English Comprehension among Spanish-English Bilingual Fourth Grade Students

ERIC Educational Resources Information Center

Proctor, C. Patrick; Mo, Elaine

2009-01-01

This study was designed to investigate the effect of English reading comprehension on cognate knowledge among a sample of Spanish-speaking bilinguals alongside their monolingual English-speaking counterparts. In order to understand this developmental relationship, the effects of English reading comprehension were controlled in regression analyses,…

Non-Standard English.

ERIC Educational Resources Information Center

Fraser, Bruce

The present paper reviews recent research in the area of nonstandard English: the major results to date, the significance of this research for education, and suggestions for further research. The notion of "standard" English resists precise definition; there is not a simple set of linguistic features which can be said to define it. The term…

The history and contemporary challenges of the US Food and Drug Administration.

PubMed

Borchers, Andrea T; Hagie, Frank; Keen, Carl L; Gershwin, M Eric

2007-01-01

The year 2006 marks the 100th anniversary of the regulatory agency now known as the US Food and Drug Administration (FDA), the first consumer protection agency of the federal government and arguably the most influential regulatory agency in the world. The FDA thus plays an integral role in the use of pharmaceuticals, not only in the United States but worldwide. The goal of this review was to present an overview of the FDA and place its current role in the perspectives of history and contemporary needs. Relevant materials for this review were identified through a search of the English-language literature indexed on MEDLINE (through 2006) using the main search terms United States Food and Drug Administration, FDA, history of the FDA, drug approvals, drug legislation, and FDA legislation. Results from the initial searches were then explored further. The statute that created the bureau which later became the FDA established this agency to prohibit interstate commerce of adulterated foods, drinks, and drugs. The Food, Drug, and Cosmetic Act that replaced it in 1938, and subsequent food and drug laws and amendments, expanded the FDA's responsibilities to cosmetics, medical devices, biological products, and radiation-emitting products. These amendments have also established the FDA as a mainly preventive regulatory agency that relies chiefly on pre-market control. As such, the FDA has played an important role in shaping the modern pharmaceutical industry by making the scientific approach and the clinical trial process the standard for establishing safety and efficacy and by making rigorous scientific analysis the predominant component of the process for pharmaceutical regulation. As shown in this review, the evolution of the FDA can be described as a series of "crisis-legislation-adaptation" cycles: a public health crisis promoted the passage of congressional legislation, which was then followed by implementation of the law by the FDA. However, the crises the FDA faces

English Teaching Profile: Syrian Arab Republic.

ERIC Educational Resources Information Center

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

A description of the status and role of English language use and instruction in Syria, in which English has been given the status of the first foreign language, is presented. The following topics are reported on: (1) general usage; (2) English within the educational system, including the length of English training, testing, syllabus construction,…

English Textbooks in Japan and Korea

ERIC Educational Resources Information Center

Yuasa, Katsura

2010-01-01

English education in Japan and Korea are similar in some respects. Although both countries are not completely but mostly monolingual societies, where citizens do not need English in their daily life, they have begun to realize the importance of English as a tool for international communication, and as a result their English education is becoming…

English Leadership Quarterly, 1998-1999.

ERIC Educational Resources Information Center

Kiernan, Henry, Ed.

1999-01-01

This journal, a publication of the National Council of Teachers of English Conference on English Leadership, publishes articles on topics of interest to those in positions of leadership in departments (elementary, secondary, or college) where English is taught. Articles in Volume 21, Number 1, August 1998 are: "Problem-Based Leadership: A…

Mandarin Chinese Dictionary: English-Chinese.

ERIC Educational Resources Information Center

Wang, Fred Fangyu

This dictionary is a companion volume to the "Mandarin Chinese Dictionary (Chinese-English)" published in 1967 by Seton Hall University. The purpose of the dictionary is to help English-speaking students produce Chinese sentences in certain cultural situations by looking up the English expressions. Natural, spoken Chinese expressions within the…

Interpreting Indian English Expository Prose.

ERIC Educational Resources Information Center

Kachru, Yamuna

1988-01-01

A study was undertaken to demonstrate that expository prose written in Indian English exhibits certain characteristics determined by the sociocultural conventions of writing in the Indian tradition. These features of Indian English texts are often judged to be inappropriate by native speakers of North American and British English, and mistakenly…

Re-examining Vernacular Black English.

ERIC Educational Resources Information Center

Wolfram, Walt

1990-01-01

Reviews two books, "American Earlier Black English," by Edgar W. Schneider, and "The Death of Black English," by Ronald Butters, that capture the essence of the renewed controversy on the reemergence of the historical issue and a new dispute over the current development of Vernacular Black English. (36 references) (JL)

Older Undergraduate English Majors and Their Self-Described Value of English

ERIC Educational Resources Information Center

Price, Joseph W.

2013-01-01

The purpose of this multiple case study was to develop an understanding of what older nontraditional undergraduate English majors voiced as the challenges, attributes, and promises concerning their choice of that academic major. Ten participants took part in this study; these were students enrolled during the Spring 2012 semester as English majors…

Yod Deletion in Fiji English: Phonological Shibboleth or L2 English?

ERIC Educational Resources Information Center

Tent, Jan

2001-01-01

Discusses one pronunciation feature shared by the vast majority of speakers of English in Fiji: the deletion of yod in non-primary stressed /Cju/ syllables. Considers variation in yod pronunciation according to ethnicity, age, gender, and education and examines whether yod deletion is a phonological shibboleth of Fiji English or merely a feature…

The Religion of Learning English in "English": A Language Educator's Reading

ERIC Educational Resources Information Center

Gao, Xuesong

2011-01-01

This essay is my reading of "English," a novel based on author Wang Gang's experiences in Urumqi, Xinjiang Uyghur Autonomous Region, Northwest China during the Cultural Revolution (1966-1976). As a language educator, I was particularly interested in the way that Wang describes learning English in the novel. The essay focuses on three…

Reading Test Performance of English-Language Learners Using an English Dictionary.

ERIC Educational Resources Information Center

Albus, Debra; Thurlow, Martha; Liu, Kristin; Bielinski, John

2005-01-01

The authors examined the effects of a simplified English dictionary accommodation on the reading-test performance of Hmong English-language learners (ELLs). Participants included a control group of 69 non-ELL students and an experimental group of 133 Hmong ELLs from 3 urban middle schools in Minnesota. In a randomized counterbalanced design, all…

Drug-Drug Interactions and Diagnostics for Drug Users With HIV and HIV/HCV Coinfections: Introduction.

PubMed

Khalsa, Jag H; Talal, Andrew H; Morse, Gene

2017-03-01

Substance use and pharmacologic treatment of co-occurring infections such as human immunodeficiency virus (HIV) and hepatitis C virus (HCV) are associated with many adverse consequences including pharmacokinetic and pharmacodynamic drug-drug interactions (DDIs). The National Institute on Drug Abuse sponsored a 2-day conference on DDIs at which clinicians/scientists from government, academia, and the pharmaceutical industry presented the most current research findings to formulate a comprehensive overview of DDIs. Specific topics discussed included drug metabolism; drug interactions between medications used in the treatment of HIV, HCV, and substance use disorders; intrahepatic concentrations and methods of assessment of drugs in liver disease of varying etiologies and degrees of impairment; and minimally invasive sampling techniques for the assessment of intrahepatic drug concentrations, viral replication, and changes in gene expression in response to treatment. Finally, the speakers identified research targets and priorities on DDIs. Areas of emphasis included development of diagnostic assays for drug concentration assessment in different organs, an enhanced understanding of factors responsible for alterations in drug metabolism and excretion, and establishment of clinical trials and work groups to study DDIs. Our long-term objective is to broaden investigation in the field of DDIs in substance users. © 2017, The American College of Clinical Pharmacology.

Associations between Psychosocial Aspects of English Classroom Environments and Motivation Types of Chinese Tertiary-Level English Majors

ERIC Educational Resources Information Center

Bi, Xuefei

2015-01-01

This study involved whether psychosocial aspects of English classroom environments had associations with the English learning motivation types of Chinese tertiary-level English majors based on a case study of approximate 1,000 English majors in their first 2 years at one of the key universities located in South China. Canonical correlation…

English Sounds and Their Spellings; a Handbook for Teachers and Students. Crowell Contemporary English Series.

ERIC Educational Resources Information Center

Allen, Robert L.; And Others

This handbook introduces the important correspondences existing between English sounds and English spelling patterns. The lessons present the vowel sounds, one by one, along with systematically selected consonant sounds, and show how each sound or combination of sounds is usually spelled in English words. Irregularly spelled words are introduced…

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…

Industrial Crafts. A Bilingual Text = Trabajos Manuales Industriales. Un Texto Bilingue.

ERIC Educational Resources Information Center

Los Angeles Unified School District, CA. Div. of Career and Continuing Education.

This bilingual instructional text, one in a series of six texts covering various vocational and technical topics, provides secondary level English and Spanish instruction in industrial crafts. Addressed in the individual units are the following topics: plastics; laminating acrylic plastic; thermoforming plastics; sawing, shaping, and finishing…

English Teaching Profile: Sarawak--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 Sarawak, Malaysia, provides 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 (preprimary, elementary, secondary, higher, vocational, adult, and teacher education). Topics covered…

Tibetan-English Dictionary with Supplement.

ERIC Educational Resources Information Center

Buck, Stuart H.

The format of this Tibetan-English dictionary includes the following: (1) after the Tibetan word or phrase, variant spellings are noted in parentheses; (2) irregular past, future, or imperative forms of the verb are also given in parentheses; (3) English definitions are separated into categories by semicolons; (4) verbal forms in English are…

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…

[Clinical relevance of drug interactions between nonsteroidal antiinflammatory drugs (NSAIDs) and antihypertensives].

PubMed

Villa, Juan; Cano, Alejandra; Franco, David; Monsalve, Mauricio; Hincapié, Jaime; Amariles, Pedro

2014-11-01

To establish the clinical relevance of drug interactions between nonsteroidal antiinflammatory drugs (NSAIDs) and antihypertensives, based on the interaction severity and probability of occurrence. Systematic review. A PubMed/Medline search was made using the MeSH terms: NSAIDs, Antihypertensive drugs, and Drug interactions. Articles between 2002 and 2012, human studies, in Spanish and English and full text access were included. Found articles were included and some of the references used in this works. Studies with in vitro methods, effects on ocular hypertension and those who do not consider the interaction NSAIDs, antihypertensives were excluded. For the selection of the papers included three independent reviewers were involved. We used a tool for data extraction and for assess of the interaction clinical relevance. Nineteen of 50 papers found were included. There were identified 21 interactions with pharmacodynamic mechanism, classified by their clinical relevance in level-2 high risk (76.2%) and level-3 medium risk (23.8%). In addition, evidence of 16 combinations of no interaction were found. Some NSAIDs may attenuate the effectiveness of antihypertensive drugs when used concurrently, especially with angiotensin converting enzyme inhibitors, diuretics, beta blockers and angiotensin receptorsii blockers. There was no evidence of effect modification of calcium channel antagonists, especially dihydropyridine, by concurrent use of NSAIDs. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

Role of Narrative Skills on Reading Comprehension: Spanish-English and Cantonese-English Dual Language Learners

ERIC Educational Resources Information Center

Uchikoshi, Yuuko; Yang, Lu; Liu, Siwei

2018-01-01

This longitudinal study examined the role of narrative skills in English reading comprehension, after controlling for vocabulary and decoding, with a sample of 112 dual language learners (DLLs), including both Spanish-English and Cantonese-English children. Decoding, vocabulary, and narrative samples were collected in the winter of first grade and…

Impact of English on Education Reforms in China: With Reference to the Learn-English Movement, the Internationalisation of Universities and the English Language Requirement in College Entrance Examinations

ERIC Educational Resources Information Center

Sun, James Jian-Min; Hu, Ping; Ng, Sik Hung

2017-01-01

When China liberalised its economy and opened up to the (Western) world, it actively promoted the English language at schools and universities on a massive scale. This learn-English movement, riding on the back of English as the dominant international language, has powered English into China's education reforms. We outline the movement and discuss…

Unconventional Internships for English Majors.

ERIC Educational Resources Information Center

Otto, Don H.

After five years of research, the English department at St. Cloud (Minnesota) State University created an internship program for English majors. The philosophy behind the program is that the typical experience of the English major in college is excellent preparation for what the college graduate will be doing in most careers in business,…

English Teaching Profile: Hong Kong.

ERIC Educational Resources Information Center

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

A review of the status of English language instruction in Hong Kong 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, vocational, adult, and teacher), the characteristics and training of English…

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…

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.…

Potentially harmful drug-drug interactions in the elderly: a review.

PubMed

Hines, Lisa E; Murphy, John E

2011-12-01

Elderly patients are vulnerable to drug interactions because of age-related physiologic changes, an increased risk for disease associated with aging, and the consequent increase in medication use. The purpose of this narrative review was to describe findings from rigorously designed observational cohort and case-control studies that have assessed specific drug interactions in elderly patients. The PubMed and International Pharmaceutical Abstracts databases were searched for studies published in English over the past 10 years (December 2000-December 2010) using relevant Medical Subject Headings terms (aged; aged, 80 and over; and drug interactions) and search terms (drug interaction and elderly). Search strategies were saved and repeated through September 2011 to ensure that the most recent relevant published articles were identified. Additional articles were found using a search of review articles and reference lists of the identified studies. Studies were included if they were observational cohort or case-control studies that reported specific adverse drug interactions, included patients aged ≥65 years, and evaluated clinically meaningful end points. Studies were excluded if they used less rigorous observational designs, assessed pharmacokinetic/pharmacodynamic properties, evaluated drug-nutrient or drug-disease interactions or interactions of drug combinations used for therapeutic benefit (eg, dual antiplatelet therapy), or had inconclusive evidence. Seventeen studies met the inclusion criteria. Sixteen studies reported an elevated risk for hospitalization in older adults associated with adverse drug interactions. The drug interactions included: angiotensin-converting enzyme (ACE) inhibitors and potassium-sparing diuretics, ACE inhibitors or angiotensin receptor blockers and sulfamethoxazole/trimethoprim, benzodiazepines or zolpidem and interacting medications, calcium channel blockers and macrolide antibiotics, digoxin and macrolide antibiotics, lithium and

Industry guidelines, laws and regulations ignored: quality of drug advertising in medical journals.

PubMed

Lankinen, Kari S; Levola, Tero; Marttinen, Kati; Puumalainen, Inka; Helin-Salmivaara, Arja

2004-11-01

To document the quality of evidence base for marketing claims in prescription drug advertisements, to facilitate identification of potential targets for quality improvement. A sample of 1036 advertisements from four major Finnish medical journals published in 2002. Marketing claims were classified in four groups: unambiguous clinical outcome, vague clinical outcome, emotive or immeasurable outcome and non-clinical outcome. Medline references were traced and classified according to the level of evidence available. The statistical variables used in the advertisements were also documented. The sample included 245 distinct advertisements with 883 marketing claims, 1-10 claims per advertisement. Three hundred thirty seven (38%) of the claims were referenced. Each claim could be supported by one reference or more, so the number of references analysed totalled 381, 1-9 references per advertisement. Nine percent of the claims implied unambiguous clinical outcomes, 68% included vague or emotive statements. Twenty one percent of the references were irrelevant to the claim. There was a fair amount of non-scientific and scientific support for the 73 unambiguous claims, but not a single claim was supported by strong scientific evidence. Vague, emotive and non-clinical claims were significantly more often supported by non-Medline or irrelevant references than unambiguous claims. Statistical parameters were stated only 34 times. Referenced marketing claims may appear more scientific, but the use of references does not guarantee the quality of the claims. For the benefit of all stakeholders, both the regulatory control and industry's self-control of drug marketing should adopt more active monitoring roles, and apply sanctions when appropriate. Concerted efforts by several stakeholders might be more effective. Copyright 2004 John Wiley & Sons, Ltd.

Variable Production of English Past Tense Morphology: A Case Study of a Thai-Speaking Learner of English

ERIC Educational Resources Information Center

Prapobaratanakul, Chariya; Pongpairoj, Nattama

2016-01-01

The study investigated variable production of English past tense morphology by an L1 Thai-speaking learner of English. Due to the absence of the past tense inflectional morphology in the Thai language, production of English past tense morphemes poses a persistent problem for L1 Thai-speaking learners of English. Hypotheses have been made in…

Drug-disease modeling in the pharmaceutical industry - where mechanistic systems pharmacology and statistical pharmacometrics meet.

PubMed

Helmlinger, Gabriel; Al-Huniti, Nidal; Aksenov, Sergey; Peskov, Kirill; Hallow, Karen M; Chu, Lulu; Boulton, David; Eriksson, Ulf; Hamrén, Bengt; Lambert, Craig; Masson, Eric; Tomkinson, Helen; Stanski, Donald

2017-11-15

Modeling & simulation (M&S) methodologies are established quantitative tools, which have proven to be useful in supporting the research, development (R&D), regulatory approval, and marketing of novel therapeutics. Applications of M&S help design efficient studies and interpret their results in context of all available data and knowledge to enable effective decision-making during the R&D process. In this mini-review, we focus on two sets of modeling approaches: population-based models, which are well-established within the pharmaceutical industry today, and fall under the discipline of clinical pharmacometrics (PMX); and systems dynamics models, which encompass a range of models of (patho-)physiology amenable to pharmacological intervention, of signaling pathways in biology, and of substance distribution in the body (today known as physiologically-based pharmacokinetic models) - which today may be collectively referred to as quantitative systems pharmacology models (QSP). We next describe the convergence - or rather selected integration - of PMX and QSP approaches into 'middle-out' drug-disease models, which retain selected mechanistic aspects, while remaining parsimonious, fit-for-purpose, and able to address variability and the testing of covariates. We further propose development opportunities for drug-disease systems models, to increase their utility and applicability throughout the preclinical and clinical spectrum of pharmaceutical R&D. Copyright © 2017 Elsevier B.V. All rights reserved.

National Workplace Literacy Program. Garment-Related Bilingual (English and Chinese) Broadcast Lessons. Book 1 and 2.

ERIC Educational Resources Information Center

Chan, Ha Yin

A compilation of transcripts of 100 bilingual English/Chinese broadcast lessons for workers in the garment industry is presented. The lessons are part of the New York Chinatown Manpower Project's Workplace Literacy Program. With the support of the Sino Radio Broadcast Corporation, the lessons are broadcast daily in the morning and again after the…

Industrial Prep, Volume Four, Junior Year--Contents: Mathematics and Guidance.

ERIC Educational Resources Information Center

Hackensack Public Schools, NJ.

As part of a 3-year comprehensive interdisciplinary program in industrial preparation for vocational students, this 11th Grade teaching guide consists of units on technical mathematics and guidance. Designed as supportive material for related physics and English curriculums, the first four sections of Volume 4 on algebra, vectors, simple machines,…

Using Flipped Learning Model in Teaching English Language among Female English Majors in Majmaah University

ERIC Educational Resources Information Center

Abdelshaheed, Bothina S. M.

2017-01-01

This study aims at investigating the effect of using Flipped Learning Model in teaching English language among female English majors in Majmaah University on their achievement in two different English courses and identifying their feelings and satisfaction about flipping their classes. The study used a pre-post test design and included two…

Rhythm in Ethiopian English: Implications for the Teaching of English Prosody

ERIC Educational Resources Information Center

Gashaw, Anegagregn

2017-01-01

In order to verify that English speeches produced by Ethiopian speakers fall under syllable-timed or stress-timed rhythm, the study tried to examine the nature of stress and rhythm in the pronunciation of Ethiopian speakers of English by focusing on one language group speaking Amharic as a native language. Using acoustic analysis of the speeches…

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…

Cross-border drug injection relationships among injection drug users in Tijuana, Mexico

PubMed Central

Wagner, Karla D.; Pollini, Robin A.; Patterson, Thomas L.; Lozada, Remedios; Ojeda, Victoria D.; Brouwer, Kimberly C.; Vera, Alicia; Volkmann, Tyson A.; Strathdee, Steffanie A.

2010-01-01

Background International borders are unique social and environmental contexts characterized by high levels of mobility. Among drug users, mobility increases risk for human immunodeficiency virus (HIV) in part through its effects on the social environment. However, the social dynamics of drug users living in border regions are understudied. Methods 1056 injection drug users (IDUs) residing in Tijuana, Mexico were recruited using respondent-driven sampling (RDS) from 2006 to 2007, and underwent surveys and testing for HIV, syphilis, and tuberculosis (TB). Using logistic regression on baseline data, we identified correlates of having ever injected drugs with someone from the US. Results Almost half (48%) reported ever injecting drugs with someone from the US. In RDS-adjusted logistic regression, factors independently associated with having ever injected with someone from the US included: having greater than middle school education (Adjusted Odds Ratio [AOR] 2.91; 95% Confidence Interval [C.I.] 1.52, 5.91), speaking English (AOR 3.24, 95% C.I. 1.96, 5.36), age (AOR 1.10 per year; 95% C.I. 1.07, 1.14), age at initiation of injection drug use (AOR 0.90 per year; 95% C.I. 0.86, 0.94), homelessness (AOR 2.61; 95% C.I. 1.27, 5.39), and having ever been incarcerated (AOR 11.82; 95% C.I., 5.22, 26.77). No associations with HIV, syphilis, TB, drug use, or injection risk behavior were detected. Conclusion Findings suggest that IDU networks in Mexico and the US may transcend international borders, with implications for cross-border transmission of infectious disease. Binational programs and policies need to consider the structure and geographic distribution of drug using networks. PMID:20889270

Survey of abuses against injecting drug users in Indonesia

PubMed Central

Davis, Sara LM; Triwahyuono, Agus; Alexander, Risa

2009-01-01

In Indonesia, an ongoing government "war on drugs" has resulted in numerous arrests and anecdotal reports of abuse in detention, but to date there has been little documentation or analysis of this issue. JANGKAR (also known in English as the Indonesian Harm Reduction Network), a nongovernmental organization (NGO) based in Jakarta, surveyed 1106 injecting drug users in 13 cities about their experiences of police abuse. Of those interviewed, 667 or 60% reported physical abuse by police. These findings indicate the importance of continuing efforts to promote police reform and harm reduction in Indonesia. PMID:19852845

[Bilingual Metric Education Module for Postsecondary and Adult Vocational Education.] Applying the Metric System (SI) in Trade and Industrial Education.

ERIC Educational Resources Information Center

Ellis Associates, Inc., College Park, MD.

This set of six instructional units on applying the metric system in trade and industrial education is one of three metric education modules designed for use with bilingual (Spanish and English) students in postsecondary and adult vocational programs. (Both the Spanish and English versions of this set are provided in the document.) Each unit…

75 FR 14604 - Guidance for Industry on Anesthetics for Companion Animals; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-26

...] Guidance for Industry on Anesthetics for Companion Animals; Availability AGENCY: Food and Drug... availability of Guidance for Industry 192 entitled ``Anesthetics for Companion Animals.'' This guidance makes recommendations for the development of anesthetic new animal drug products for companion animals. The guidance...

English in Malaysia

ERIC Educational Resources Information Center

Foo, Bernadette; Richards, Cynthia

2004-01-01

This article seeks to lay out the use and importance of English in Malaysia from the time when the British ruled what was then Malaya to the present moment. When the British came to colonize the country, they brought with them their culture, their language and their beliefs. They introduced the English language as the medium of instruction in the…

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.

A Comparison of Motivation to Learn English between English Major and Non-English Major Students in a Vietnamese University

ERIC Educational Resources Information Center

Ngo, Huong; Spooner-Lane, Rebecca; Mergler, Amanda

2017-01-01

Despite the plethora of literature examining higher education students' motivation to learn a second language, it is not known if students who choose to study English as their major differ from those who are required to study English as the minor component of their wider degree. Drawing on self-determination theory, this paper reports on the…

The Most Frequently Used English Phrasal Verbs in American and British English: A Multicorpus Examination

ERIC Educational Resources Information Center

Liu, Dilin

2011-01-01

This study uses the Corpus of Contemporary American English and the British National Corpus as data and Biber, Johansson, Leech, Conrad, and Finegan's (1999) and Gardner and Davies' (2007) informative studies as a starting point and reference. The study offers a cross-English variety and cross-register examination of the use of English phrasal…

Enhancing Students' Performance in the English Language through Literature-in-English in the Secondary Schools

ERIC Educational Resources Information Center

Adejimola, Amuseghan Sunday; Ojuolape, Momoh Adenike

2013-01-01

This paper examines the relationship between the English Language and Literature-in-English in secondary schools in Nigeria. The purpose is to explore and expose the interdependence of the two subjects in enhancing English language competence. Apart from the educational advantages, it is also in the opinion of the writer that language is not only…

Sub-Syllabic Processing in Young Korean-English Bilinguals: Semivowel Placement Differences between Korean and English

ERIC Educational Resources Information Center

Baek, Seunghyun

2014-01-01

This study investigated the sub-syllabic awareness of two groups of 86 Korean kindergarteners learning English as a foreign language (EFL) or English as a second language (ESL). In addition, it explored the cross-language transfer of sub-syllabic units between Korean and English by taking into account their lexical abilities with respect to the…

Exposure to Multiple Accents of English in the English Language Teaching Classroom: From Second Language Learners' Perspectives

ERIC Educational Resources Information Center

Sung, Chit Cheung Matthew

2016-01-01

As a result of the global presence of English as a Lingua Franca (ELF), it has been argued that learners of English should be exposed to a range of varieties of English, rather than a single variety of English, so that they can be better prepared to communicate with other people in ELF communication. However, little is known about second language…

Quantum mechanics implementation in drug-design workflows: does it really help?

PubMed

Arodola, Olayide A; Soliman, Mahmoud Es

2017-01-01

The pharmaceutical industry is progressively operating in an era where development costs are constantly under pressure, higher percentages of drugs are demanded, and the drug-discovery process is a trial-and-error run. The profit that flows in with the discovery of new drugs has always been the motivation for the industry to keep up the pace and keep abreast with the endless demand for medicines. The process of finding a molecule that binds to the target protein using in silico tools has made computational chemistry a valuable tool in drug discovery in both academic research and pharmaceutical industry. However, the complexity of many protein-ligand interactions challenges the accuracy and efficiency of the commonly used empirical methods. The usefulness of quantum mechanics (QM) in drug-protein interaction cannot be overemphasized; however, this approach has little significance in some empirical methods. In this review, we discuss recent developments in, and application of, QM to medically relevant biomolecules. We critically discuss the different types of QM-based methods and their proposed application to incorporating them into drug-design and -discovery workflows while trying to answer a critical question: are QM-based methods of real help in drug-design and -discovery research and industry?

Use of English Corpora as a Primary Resource to Teach English to the Bengali Learners

ERIC Educational Resources Information Center

Dash, Niladri Sekhar

2011-01-01

In this paper we argue in favour of teaching English as a second language to the Bengali learners with direct utilisation of English corpora. The proposed strategy is meant to be assisted with computer and is based on data, information, and examples retrieved from the present-day English corpora developed with various text samples composed by…

Judgement of Countability and Plural Marking in English by Native and Non-Native English Speakers

ERIC Educational Resources Information Center

Tsang, Art

2017-01-01

Learning whether English nouns are countable or not is a source of great difficulty for many ESL/EFL learners. In the present study, a grammaticality judgement task comprised of a range of nouns representative of the different facets of the countability system in English was distributed to 82 native speakers of English (NSs) and 98 non-native…

English as a Foreign Language Students' Opinions about the Use of English on the Internet

ERIC Educational Resources Information Center

Coskun, Abdullah

2017-01-01

As in many other fields, the Internet has been used for educational purposes, especially for foreign language learning. This study has the main objective to investigate English as a Foreign Language (EFL) students' opinions about the use of English on the Internet. By means of a Likert-type questionnaire dealing with the use of English on the…

[Japanese learners' processing time for reading English relative clauses analyzed in relation to their English listening proficiency].

PubMed

Oyama, Yoshinori

2011-06-01

The present study examined Japanese university students' processing time for English subject and object relative clauses in relation to their English listening proficiency. In Analysis 1, the relation between English listening proficiency and reading span test scores was analyzed. The results showed that the high and low listening comprehension groups' reading span test scores do not differ. Analysis 2 investigated English listening proficiency and processing time for sentences with subject and object relative clauses. The results showed that reading the relative clause ending and the main verb section of a sentence with an object relative clause (such as "attacked" and "admitted" in the sentence "The reporter that the senator attacked admitted the error") takes less time for learners with high English listening scores than for learners with low English listening scores. In Analysis 3, English listening proficiency and comprehension accuracy for sentences with subject and object relative clauses were examined. The results showed no significant difference in comprehension accuracy between the high and low listening-comprehension groups. These results indicate that processing time for English relative clauses is related to the cognitive processes involved in listening comprehension, which requires immediate processing of syntactically complex audio information.

The consequences of English language testing for international health professionals and students: An Australian case study.

PubMed

Rumsey, Michele; Thiessen, Jodi; Buchan, James; Daly, John

2016-02-01

To discuss the perceptions about the International English Language Testing System (IELTS) and its impact on migration and practice of migrant health professionals in Australia. Thematic analysis of interviews with 14 health industry participants and 35 migrated health professionals in Australia. Language testing is a barrier to health professional registration for migrant health workers in Australia. While two English language tests are recognised by the registration authorities in Australia, it is the International English Language Testing System that is most commonly used. This paper reports that study participants had underlying negative perceptions of the International English Language Testing System which they report, affect their move to Australia. These negative perceptions are caused by: frustration due to changes to processes for migration and registration; challenges regarding the structure of IELTS including timing of when test results expire, scoring requirements, cost, and suitability; and the resulting feelings of inadequacy caused by the test itself. This study has shown that some respondents have experienced difficulties in relation to the International English Language Testing System as part of their migration process. It was found that there is very little research into the effectiveness of the IELTS as it is currently administered for overseas health care professionals. Several recommendations are provided including areas for further research. Copyright © 2015 Elsevier Ltd. All rights reserved.

Brunei English: A Developing Variety

ERIC Educational Resources Information Center

O'Hara-Davies, Breda

2010-01-01

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

Are Danish doctors comfortable teaching in English?

PubMed

Nilas, L; Løkkegaard, E C; Laursen, J B; Kling, J; Cortes, D

2016-08-27

From 2012-2015, the Departments of Obstetrics and Gynecology and of Pediatrics at the University of Copenhagen conducted a project, "Internationalization at Home ", offering clinical teaching in English. The project allowed international students to work with Danish speaking students in a clinical setting. Using semi-quantitative questionnaires to 89 clinicians about use of English and need for training, this paper considers if Danish clinical doctors are prepared to teach in English. The majority self-assessed their English proficiency between seven and eight on a 10 unit visual analogue scale, with 10 equivalent to working in Danish, while 15 % rated five or less. However, one-fourth found teaching and writing in English to be twice as difficult than in Danish, and 12 % rated all teaching tasks in English at four or less compared to Danish. The self-assessed need for additional English skills was perceived low. Teaching in English was rated as 30 % more difficult than in Danish, and a significant subgroup of doctors had difficulties in all forms of communication in English, resulting in challenges when introducing international students in non-native English speaking medical departments.

Conceptual Representation Changes in Indonesian-English Bilinguals.

PubMed

Hartanto, Andree; Suárez, Lidia

2016-10-01

This study investigated conceptual representations changes in bilinguals. Participants were Indonesian-English bilinguals (dominant in Indonesian, with different levels of English proficiency) and a control group composed of English-dominant bilinguals. All completed a gender decision task, in which participants decided whether English words referred to a male or female person or animal. In order to explore conceptual representations, we divided the words into gender-specific and gender-ambiguous words. Gender-specific words were words in which conceptual representations contained gender as a defining feature, in both English and Indonesian (e.g., uncle). In contrast, gender-ambiguous words were words in which gender was a defining feature in English but not a necessary feature in Indonesian (e.g., nephew and niece are both subsumed under the same word, keponakan, in Indonesian). The experiment was conducted exclusively in English. Indonesian-English bilinguals responded faster to gender-specific words than gender-ambiguous words, but the difference was smaller for the most proficient bilinguals. As expected, English-dominant speakers' response latencies were similar across these two types of words. The results suggest that English concepts are dynamic and that proficiency leads to native-like conceptual representations.

The Professional Development Requirements of Workplace English Language and Literacy Programme Practitioners. An Adult Literacy National Project Report

ERIC Educational Resources Information Center

Berghella, Tina; Molenaar, John; Wyse, Linda

2006-01-01

This report examines the extent and nature of professional development required to meet the current and future needs of Workplace English Language and Literacy Programme practitioners. While the working environment for such practitioners is becoming more complex, with greater demands on them to have industry knowledge and project management…

National Workplace Literacy Program. Garment-Related Bilingual (English & Chinese) T.V. Broadcast Lessons. Book I: Episodes 1-15.

ERIC Educational Resources Information Center

Chinatown Manpower Project, Inc., New York, NY.

This publication contains a series of 15 garment-related bilingual (English and Chinese) television broadcast lessons produced by the National Workplace Literacy Program of Chinatown Manpower Project, Inc. (Other partners were the Union of Needletrades, Industrial and Textile Employees and the Greater Blouse, Skirt and Undergarment Association in…

English Language Learners. What Works Clearinghouse Topic Report

ERIC Educational Resources Information Center

What Works Clearinghouse, 2007

2007-01-01

English language learners are students with a primary language other than English who have a limited range of speaking, reading, writing, and listening skills in English. English language learners also include students identified and determined by their school as having limited English proficiency and a language other than English spoken in the…

School-Based Drug Abuse Prevention Programs in High School Students

ERIC Educational Resources Information Center

Sharma, Manoj; Branscum, Paul

2013-01-01

Drug abuse, or substance abuse, is a substantial public health problem in the United States, particularly among high school students. The purpose of this article was to review school-based programs implemented in high schools for substance abuse prevention and to suggest recommendations for future interventions. Included were English language…

[The pharmaceutical industry in France: the turning point of 1915].

PubMed

Bonnemain, Bruno

2015-12-01

For several convergent reasons, 1915 was a key period for the pharmaceutical industry in France. The overall realization that France was dependent on Germany for chemical and pharmaceutical products came from shortages of key drugs but also from massive use of poison gas for which France was not able to face this unexpected event. France's shortage for chemists properly trained to answer the needs of industry, the weak relationship between industry and faculty, the uncomfortable situation of specialty drugs, the regulations on patents and trademarks were many subjects of controversies which will contribute to the analysis of the source of this French dependence to Germany. It will be at the origin of new orientations after the war for the pharmaceutical industry and the French society. The objective was to be independent for drugs and consequently to resolve the identified issues, as well as to have a dynamic industrial research. The creation and development of several pharmaceutical companies after the war was a more or less direct benefit from the considerations starting in 1915.

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

... drug substance than what is intended to be delivered to the patient. This excess amount of drug... issue not only to the patient, but also to others including family members, caregivers, children, and...

Diphthong Changes in Style Shifting from Southern English to Standard American English.

ERIC Educational Resources Information Center

Weil, Karen S.; Fitch, James L.; Wolfe, Virginia I.

2000-01-01

Specific diphthongs were produced by four individuals from the coastal southern dialect region who were selected from among those who had successfully completed an accent-reduction program. Results showed that diphthongs used in Southern English were shorter and had less noticeable transitional elements than those in Standard American English.…

Published Views of Two-Year College English as Reflected in English Textbooks.

ERIC Educational Resources Information Center

Bowyer, Dolores LaVerna

This study answered four research questions: (1) Can textbook content for freshman English be determined from statements of leaders in two-year college English curriculum? (2) Do current textbooks reflect the content suggested by these leaders? (3) Are textbooks specifically designed for two-year college students? (4) How can publishers and…

Removing Bias towards World Englishes: The Development of a Rater Attitude Instrument Using Indian English as a Stimulus

ERIC Educational Resources Information Center

Hsu, Tammy Huei-Lien

2016-01-01

This study explores the attitudes of raters of English speaking tests towards the global spread of English and the challenges in rating speakers of Indian English in descriptive speaking tasks. The claims put forward by language attitude studies indicate a validity issue in English speaking tests: listeners tend to hold negative attitudes towards…

Using Local Style When Writing in English: The Citing Behaviour of Indonesian Authors in English Research Article Introductions

ERIC Educational Resources Information Center

Arsyad, Safnil; Adila, Destiantari

2017-01-01

When writing journal articles in English, authors are expected to comply with the conventionally appropriate rhetorical style. This may be problematic for non-native speakers of English, such as Indonesian authors who write in English. The purpose of this study is to investigate the rhetorical style of reviewing prior knowledge in English research…