WorldWideScience

Sample records for industry postmarketing studies

  1. 522 Postmarket Surveillance Studies

    Data.gov (United States)

    U.S. Department of Health & Human Services — The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the...

  2. [Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

    Science.gov (United States)

    Inagaki, Osamu

    2016-04-01

    Pharmaceutical companies recognize the importance of post-marketing studies because they are crucial in the generation of clinical evidences for the usage of new medicines. To generate clinical evidences, quality of post-marketing studies should be well controlled from view point of "ethical conduction" and "reliability of results". In addition, control of conflict of interest (COI) between researchers and industries is also indispensable and is requested for the transparency of the studies. Japan Pharmaceutical Manufacturers Association(JPMA)stresses its commitment to the progressof transparency in post-marketing studies.

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

    Science.gov (United States)

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

    2017-01-01

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

  4. Postmarket Requirements and Commitments

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical...

  5. The role of the pharmaceutical animal health industry in post-marketing surveillance of resistance.

    Science.gov (United States)

    Lens, S

    1993-06-01

    The pharmaceutical animal health industry must be committed to the total life cycle of products, i.e. during both the pre- and post-marketing period. Support of antibacterial agents during the postmarketing period is not restricted to maintaining a well-established distribution and promotion system. Care has to be taken continuously to maintain and/or improve the quality, safety (for user, target animal and environment) and clinical efficacy. The pharmaceutical industry contributes to this by: 1. Introducing antibacterials in different animal species for the most effective disease condition only and by ensuring the veterinary profession is informed about relevant findings on: a. the mechanism of action; b. pharmacodynamic properties; c. pharmacokinetic properties (plasma, target tissue); d. clinical efficacy data and in vitro sensitivity data; e. valid species-specific MIC breakpoints; f. precise dose and treatment regime. 2. Updating on a regular basis on: a. new findings on the mechanism of action (in vitro and in vivo); b. the optimal use program in the light of changes in animal husbandry, farm management and epidemiology on national and international level; c. adjustment of species-specific MIC breakpoints when necessary. 3. Providing continuous information in collaboration with animal health laboratories about: a. clinical field surveillance for efficacy (national, international); b. in vitro sensitivity/resistance surveillance (national, international); c. use of in vitro data to support prediction of in vivo efficacy. Surveillance of resistance, in vitro, is therefore part of a package of information needed on a routine basis by the pharmaceutical industry to allow the best possible use of antibacterials and to minimize induction of resistance.(ABSTRACT TRUNCATED AT 250 WORDS)

  6. Design and analysis of post-marketing research.

    Science.gov (United States)

    Zhou, Xiao-Hua Andrew; Yang, Wei

    2013-07-01

    A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

  7. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.

    Science.gov (United States)

    Hoekman, Jarno; Klamer, Thea T; Mantel-Teeuwisse, Aukje K; Leufkens, Hubert G M; De Bruin, Marie L

    2016-07-01

    The aim of the present study was to provide an insight into the characteristics and follow-up of postmarketing studies of medicines that were conditionally authorized in the European Union (EU). We compiled a list of all postmarketing studies attached as specific obligations to the licence of medicines that were granted conditional marketing authorization from January 2006 to April 2014. Studies were characterized based on their objective, design, status upon marketing authorization (MA) and due data set by authorities. They were linked to online study registrations (Clinicaltrials.gov, ENCePP) to determine completion date. We described and associated characteristics of studies and medicines, and determined whether studies were completed on time. A total of 59 postmarketing studies were requested for 21 conditionally authorized medicines. Most studies had an interventional study design (73%), were ongoing upon MA (61%) and aimed to provide additional data on efficacy (45%). Interventional studies were more often ongoing and providing efficacy data, while observational and other studies were more often new and providing safety data. Frequent grounds for requesting postmarketing studies were 'long-term follow-up' and 'increase data on subpopulations'. Of the 34 studies eligible for follow-up analysis, 26 (76%) were completed and 17 (50%) completed on time. Actual completion time took a median (interquartile range) of 274 (-121 to 556) days longer than expected. Our results indicated that most postmarketing studies attached to a conditional marketing authorization were eventually completed but that half were completed with a substantial delay. The observations suggest caution when broadening the use of postmarketing studies for resolving uncertainties about benefits and risks after MA. © 2016 The British Pharmacological Society.

  8. Characteristics and follow‐up of postmarketing studies of conditionally authorized medicines in the EU

    Science.gov (United States)

    Klamer, Thea T.; Mantel‐Teeuwisse, Aukje K.; Leufkens, Hubert G. M.; De Bruin, Marie L.

    2016-01-01

    Aim The aim of the present study was to provide an insight into the characteristics and follow‐up of postmarketing studies of medicines that were conditionally authorized in the European Union (EU). Methods We compiled a list of all postmarketing studies attached as specific obligations to the licence of medicines that were granted conditional marketing authorization from January 2006 to April 2014. Studies were characterized based on their objective, design, status upon marketing authorization (MA) and due data set by authorities. They were linked to online study registrations (Clinicaltrials.gov, ENCePP) to determine completion date. We described and associated characteristics of studies and medicines, and determined whether studies were completed on time. Results A total of 59 postmarketing studies were requested for 21 conditionally authorized medicines. Most studies had an interventional study design (73%), were ongoing upon MA (61%) and aimed to provide additional data on efficacy (45%). Interventional studies were more often ongoing and providing efficacy data, while observational and other studies were more often new and providing safety data. Frequent grounds for requesting postmarketing studies were ‘long‐term follow‐up’ and ‘increase data on subpopulations’. Of the 34 studies eligible for follow‐up analysis, 26 (76%) were completed and 17 (50%) completed on time. Actual completion time took a median (interquartile range) of 274 (−121 to 556) days longer than expected. Conclusions Our results indicated that most postmarketing studies attached to a conditional marketing authorization were eventually completed but that half were completed with a substantial delay. The observations suggest caution when broadening the use of postmarketing studies for resolving uncertainties about benefits and risks after MA. PMID:26992001

  9. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU

    NARCIS (Netherlands)

    Hoekman, Jarno; Klamer, Thea T.; Mantel-Teeuwisse, Aukje K.; Leufkens, Hubert G M; De Bruin, Marie L.

    2016-01-01

    Aim: The aim of the present study was to provide an insight into the characteristics and follow-up of postmarketing studies of medicines that were conditionally authorized in the European Union (EU). Methods: We compiled a list of all postmarketing studies attached as specific obligations to the

  10. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

    Science.gov (United States)

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

  11. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

    Directory of Open Access Journals (Sweden)

    Ross JS

    2015-05-01

    Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

  12. [Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

    2014-09-01

    Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

  13. [Strategy of constructing post-market integral evaluation system of traditional Chinese medicine injection].

    Science.gov (United States)

    Zhang, Xiao-Yu; Wang, Yan-Ping; Lin, Li-Kai; Shang, Hong-Cai; Wang, Yong-Yan

    2017-08-01

    As an important representative of modern Chinese medicine, traditional Chinese medicine (TCM) injzection has become an indispensable part of the Chinese medicine industry. However, its development is now restricted by the bottleneck of insufficient core competitiveness, low-level research and production, even injection quality and the safe use are not guaranteed. Thus, it is urgent to reevaluate post-marketing TCM injection generally and to make secondary development. Under current circumstances, taking major brands which have good clinical and market foundation, as well as research value, as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry. Unlike oral proprietary Chinese medicine, the cultivatation of major brands of TCM injection needs higher technical support, quality standards and more timely feedback. Therefore, a post-market integral evaluation system adaptive to TCM injection is required. This article discussed some key points on the construction of a post-market integral evaluation system of TCM injection in three levels: optimizing evaluation methods, building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises, and finally constructing the integral evaluation system. A "five to one" structure has been proposed to enhance TCM injection effectiveness, safety and adaptability on the whole, which are from the following aspects: mechanism research, clinical evidence validation, literature information mining, sustainable development of resources and industrialization operation. Copyright© by the Chinese Pharmaceutical Association.

  14. A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

    Science.gov (United States)

    Velentgas, Priscilla; Bohn, Rhonda L; Brown, Jeffrey S; Chan, K Arnold; Gladowski, Patricia; Holick, Crystal N; Kramer, Judith M; Nakasato, Cynthia; Spettell, Claire M; Walker, Alexander M; Zhang, Fang; Platt, Richard

    2008-12-01

    We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative. This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls. The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007. This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system. Copyright (c) 2008 John Wiley & Sons, Ltd.

  15. Estimating post-marketing exposure to pharmaceutical products using ex-factory distribution data.

    Science.gov (United States)

    Telfair, Tamara; Mohan, Aparna K; Shahani, Shalini; Klincewicz, Stephen; Atsma, Willem Jan; Thomas, Adrian; Fife, Daniel

    2006-10-01

    The pharmaceutical industry has an obligation to identify adverse reactions to drug products during all phases of drug development, including the post-marketing period. Estimates of population exposure to pharmaceutical products are important to the post-marketing surveillance of drugs, and provide a context for assessing the various risks and benefits, including drug safety, associated with drug treatment. This paper describes a systematic approach to estimating post-marketing drug exposure using ex-factory shipment data to estimate the quantity of medication available, and dosage information (stratified by indication or other factors as appropriate) to convert the quantity of medication to person time of exposure. Unlike the non-standardized methods often used to estimate exposure, this approach provides estimates whose calculations are explicit, documented, and consistent across products and over time. The methods can readily be carried out by an individual or small group specializing in this function, and lend themselves to automation. The present estimation approach is practical and relatively uncomplicated to implement. We believe it is a useful innovation. Copyright 2006 John Wiley & Sons, Ltd.

  16. 77 FR 11134 - Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary...

    Science.gov (United States)

    2012-02-24

    ... organizational unit responsible for adverse event reporting compliance when these conditions exist and when the...'s current thinking on postmarketing adverse event reporting for medical products and dietary...

  17. Sample size for post-marketing safety studies based on historical controls.

    Science.gov (United States)

    Wu, Yu-te; Makuch, Robert W

    2010-08-01

    As part of a drug's entire life cycle, post-marketing studies are an important part in the identification of rare, serious adverse events. Recently, the US Food and Drug Administration (FDA) has begun to implement new post-marketing safety mandates as a consequence of increased emphasis on safety. The purpose of this research is to provide exact sample size formula for the proposed hybrid design, based on a two-group cohort study with incorporation of historical external data. Exact sample size formula based on the Poisson distribution is developed, because the detection of rare events is our outcome of interest. Performance of exact method is compared to its approximate large-sample theory counterpart. The proposed hybrid design requires a smaller sample size compared to the standard, two-group prospective study design. In addition, the exact method reduces the number of subjects required in the treatment group by up to 30% compared to the approximate method for the study scenarios examined. The proposed hybrid design satisfies the advantages and rationale of the two-group design with smaller sample sizes generally required. 2010 John Wiley & Sons, Ltd.

  18. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    Science.gov (United States)

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  19. Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Kazuo Iijima

    Full Text Available Clinical studies for assessing the effectiveness and safety in a premarketing setting are conducted under time and cost constraints. In recent years, postmarketing data analysis has been given more attention. However, to our knowledge, no studies have compared the effectiveness and the safety between the pre- and postmarketing settings. In this study, we aimed to investigate the importance of the postmarketing data analysis using clinical data.Studies on capsule endoscopy with rich clinical data in both pre- and postmarketing settings were selected for the analysis. For effectiveness, clinical studies published before October 10, 2015 comparing capsule endoscopy and conventional flexible endoscopy measuring the detection ratio of obscure gastrointestinal bleeding were selected (premarketing: 4 studies and postmarketing: 8 studies from PubMed (MEDLINE, Cochrane Library, EMBASE and Web of Science. Among the 12 studies, 5 were blinded and 7 were non-blinded. A time series meta-analysis was conducted. Effectiveness (odds ratio decreased in the postmarketing setting (premarketing: 5.19 [95% confidence interval: 3.07-8.76] vs. postmarketing: 1.48 [0.81-2.69]. The change in odds ratio was caused by the increase in the detection ratio with flexible endoscopy as the control group. The efficacy of capsule endoscopy did not change between pre- and postmarketing settings. Heterogeneity (I2 increased in the postmarketing setting because of one study. For safety, in terms of endoscope retention in the body, data from the approval summary and adverse event reports were analyzed. The incidence of retention decreased in the postmarketing setting (premarketing: 0.75% vs postmarketing: 0.095%. The introduction of the new patency capsule for checking the patency of the digestive tract might contribute to the decrease.Effectiveness and safety could change in the postmarketing setting. Therefore, time series meta-analyses could be useful to continuously monitor the

  20. Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

    Science.gov (United States)

    Zeitoun, Jean-David; Baron, Gabriel; Vivot, Alexandre; Atal, Ignacio; Downing, Nicholas S; Ross, Joseph S; Ravaud, Philippe

    2018-01-15

    Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment. Supplemental indications were retrieved from regulatory documents and publication rate was assessed by two different methods. Ten novel anticancer agents were eligible: five were indicated for hematologic malignancies and the remaining five for solid cancers (three for kidney cancer). We identified 2,345 post-marketing trials; 1,362 (58.1%) targeted an indication other than the originally approved one. We observed extreme variations among drugs in both number of post-marketing trials (range 8-530) and overall population to be enrolled per trial (1-8,381). Post-marketing trials assessed almost all types of cancers, the three most frequently studied cancers being leukemia, kidney cancer and myeloma. In all, 6.6% of post-marketing trials had a clinical endpoint as a primary outcome, and 35.9% and 54.1% had a safety or surrogate endpoint, respectively, as a primary outcome. Nine drugs obtained approval for supplemental indications. The publication rate at 10 years was 12.3 to 26.1% depending on the analysis method. In conclusion, we found that post-marketing research in oncology is highly heterogeneous and the publication rate of launched trials is low. © 2017 UICC.

  1. [Application of Markov model in post-marketing pharmacoeconomic evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Sun, Wentao; Xie, Yanming; Wang, Yongyan

    2011-10-01

    In post-marketing study of traditional Chinese medicine (TCM), pharmacoeconomic evaluation has an important applied significance. However, the economic literatures of TCM have been unable to fully and accurately reflect the unique overall outcomes of treatment with TCM. For the special nature of TCM itself, we recommend that Markov model could be introduced into post-marketing pharmacoeconomic evaluation of TCM, and also explore the feasibility of model application. Markov model can extrapolate the study time horizon, suit with effectiveness indicators of TCM, and provide measurable comprehensive outcome. In addition, Markov model can promote the development of TCM quality of life scale and the methodology of post-marketing pharmacoeconomic evaluation.

  2. [Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Fu, Yingkun; Xie, Yanming

    2011-10-01

    In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

  3. [Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection].

    Science.gov (United States)

    Xiao, Ying; Zhao, Yubin; Xie, Yanming

    2011-10-01

    The nested case-control study design (or the case-control in a cohort study) is described here as a new study design used in safe evaluation of post-marketing traditional Chinese medicine injection. In the nested case-control study, cases of a disease that occur in a defined cohort are identified and, for each, a specified number of matched controls is selected from among those in the cohort who have not developed the disease by the time of disease occurrence in the case. For many research questions, the nested case-control design potentially offers impressive reductions in costs and efforts of data collection and analysis compared with the full cohort approach, with relatively minor loss in statistical efficiency. The nested case-control design is particularly advantageous for studies in safe evaluation of post-marketing traditional Chinese medicine injection. Some examples of the application of nested case-control study were given.

  4. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    Science.gov (United States)

    Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

    2017-06-01

    An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post-marketing

  5. Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

    Science.gov (United States)

    Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

    2015-06-01

    All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  6. [Thought on several problems of clinical revaluation of post-marketing herb research].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2010-06-01

    The revaluation of post-marketing herb is a complex research work, which concerns widely content and difficult to put it into practice. The starting of our country's revaluation post-marketing herb was comparatively late. It should profect it both in laws and regulations mechanism as well as technological specification. This article is try to focus on some attention problems in revaluation of postmarketing herb process. Such as the laws and regulations demand, the basement and the subject of revaluation of post-marketing herb.

  7. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    Energy Technology Data Exchange (ETDEWEB)

    Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

    2015-11-15

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  8. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

    Science.gov (United States)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F

    2015-11-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

  9. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    International Nuclear Information System (INIS)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

    2015-01-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  10. 76 FR 23825 - Study Methodologies for Diagnostics in the Postmarket Setting; Public Workshop

    Science.gov (United States)

    2011-04-28

    ... understanding of the performance of diagnostics at the postmarket settings. II. Who is the target audience for... interested parties. The target audience is professionals in the scientific community with experience in...

  11. [Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].

    Science.gov (United States)

    Li, Xuelin; Tang, Jinfa; Meng, Fei; Li, Chunxiao; Xie, Yanming

    2011-10-01

    To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection. Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis. Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions. The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.

  12. [Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

    Science.gov (United States)

    Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

    2018-01-01

     Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

  13. [The importance of defining methodology for post-marketing observational studies on cardiovascular therapies].

    Science.gov (United States)

    Pelliccia, Francesco; Barillà, Francesco; Tanzilli, Gaetano; Viceconte, Nicola; Paravati, Vincenzo; Mangieri, Enrico; Gaudio, Carlo

    2017-01-01

    In recent years, a growing number of observational studies in cardiology have been carried out following the criticism that rigid design of randomized clinical trials produces information that is not applicable to the general patient. This approach is very common in several branches of medicine, first of all oncology, but has often been considered marginal in cardiology. The recent introduction of new oral anticoagulants (NOACs) on the market, however, has seen a proliferation of "real-life" studies, drawing the attention of cardiologists to the advantages and limitations of post-marketing studies. NOACs have been approved for use on the basis of large randomized clinical trials that have clearly documented their efficacy and safety. Since they have become available, the analysis of phase IV data has been considered crucial and therefore a great amount of information on the use of NOACs in daily practice has become available. It should be considered, however, that the possibility exists that results obtained from "real-world" studies, which do not apply rigid scientific criteria, may lead to incorrect conclusions. Accordingly, it is mandatory to fully define the operational standards of observational studies. All the protagonists of post-marketing analysis (physicians, epidemiologists, pharmacologists, statisticians) should handle the data strictly in order to ensure their reliability and comparability with other studies. To this end, it is crucial that researchers follow rigorous operational protocols for phase IV studies. Briefly, any "real-life" study should be prospective and adhere to what is prespecified by the research protocol - which must illustrate the background and rationale of the study, define its primary endpoint, and detail the methods, i.e. study design, population and variables.

  14. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    Science.gov (United States)

    Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

    2015-06-01

    The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

  15. [Exploration of how to formulate guidelines on post-marketing traditional Chinese medicine surveillance].

    Science.gov (United States)

    Zhang, Wen; Xie, Yan-Ming; Yu, Wen-Ya

    2013-09-01

    Combining the world health organization's (WHO), the United States and the European union's relevant laws and guidelines on post-marketing drug surveillance to judge the status of post-marketing surveillance of traditional Chinese medicine(TCM) in China. We found that due to the late start of post-marketing surveillance of traditional Chinese medicine, the appropriate guidelines are yet to be developed. Hence, hospitals, enterprises and research institutions do not have a shared foundation from which to compare their research results. Therefore there is an urgent need to formulate such post-marketing surveillance guidelines. This paper has used as guidance various technical documents such as, "procedures to formulate national standards" and "testing methods of management in formulating traditional Chinese medicine standards" and has combined these to produce a version of post-marketing surveillance particular to Chinese medicine in China. How to formulate these guidelines is discussed and procedures and methods to formulate technical specifications are introduced. These provide a reference for future technical specifications and will assist in the development of TCM.

  16. A mortality index for postmarketing surveillance of new medications.

    Science.gov (United States)

    Rose, J C; Unis, A S

    2000-03-01

    The rate of introduction of new pharmaceuticals is growing as a result of advances in molecular pharmacology and targeted drug development. The Fatal Toxicity Index (FTI) has been proposed as a means for monitoring drug toxicity through post-marketing surveillance. The FTI requires data regarding the general availability of a particular agent in the community which, in the US, is proprietary. The authors propose a Mortality Index as an alternative method for calculating relative lethality that does not rely on proprietary information for postmarketing surveillance. Using data from the Toxic Exposure Surveillance System (TESS) a Mortality Index was calculated from the proportion of deaths occurring among all patients who present to a health care facility with an overdose on the same agent or class of agents. The average Mortality Index for various drugs or drug classes for the years 1989 to 1997 is reported. Because the Mortality Index for desipramine appeared much greater than that for the other tricyclics, a chi-squared analysis was performed. The authors conclude, based on this analysis, that desipramine is significantly more likely to lead to death after overdosage than any other tricyclic antidepressant in the study. Also, the Mortality Index appeared to identify the impact of pediatric formulations on overdose lethality. We conclude that the Mortality Index may be a useful tool for determining the safety of agents during the postmarketing surveillance phase.

  17. [Taking evaluation of post-marketing as point of cut-in to promote systematic research of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Yong-yan; Wang, Zhi-fei; Xie, Yan-ming

    2014-09-01

    Research on post-marketing Chinese medicine should be the systematic study from application to mechanism. Clinical evaluation is the basis of mechanism study, we can find the clue from clinical evaluation, then make a mechanism study to find the reason, then apply the results to clinic. So it is a virtuous circle. In order to achieve it, we cannot be limited to traditional Chinese medicine, we should form multi-disciplinary team under the direction of grand science thinking, try hard to put industry-university-research institute collaboration association to use, and if necessary, explore the new model of the whole nation system. An appropriate operation mechanism is very important.

  18. How to establish precise proprietary Chinese medicine in post-marketing reappraisal?

    Directory of Open Access Journals (Sweden)

    Ran Tian

    2017-10-01

    Full Text Available The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern. The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine. In this paper, we propose a reappraisal protocol called “precise proprietary Chinese medicine” to precisely i define the therapeutic aim; ii design the protocol; iii control the quality of proprietary Chinese medicine; iv implement the protocol in the trial; v study the mechanism-of-action of the proprietary Chinese medicine and vi describe the indications of the proprietary Chinese medicine. We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.

  19. [Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.

  20. 77 FR 9256 - Design and Methodology for Postmarket Surveillance Studies Under Section 522 of the Federal Food...

    Science.gov (United States)

    2012-02-16

    ... postmarket setting. 2. Who is the target audience for this public workshop? Who should attend this public workshop? This workshop is open to all interested parties. The target audience is professionals in the...

  1. [Discussion on development of four diagnostic information scale for clinical re-evaluation of postmarketing herbs].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-12-01

    Post-marketing re-evaluation of Chinese herbs can well reflect Chinese medicine characteristics, which is the most easily overlooked the clinical re-evaluation content. Since little attention has been paid to this, study on the clinical trial design method was lost. It is difficult to improving the effectiveness and safety of traditional Chinese medicine. Therefore, more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design, the study of Chinese medical information collection scale and statistical analysis methods, so as to improve the clinical trial design method study about tcm syndrome of Chinese herbs postmarketing re-evalutation status.

  2. Arthritis, Rheumatism and Aging Medical Information System Post-Marketing Surveillance Program.

    Science.gov (United States)

    Singh, G

    2001-05-01

    The Arthritis, Rheumatism, and Aging Post-Marketing Surveillance Program (ARAMIS-PMS) is a collection of multicenter, prospective, noninterventional, observational longitudinal studies of patients with rheumatic diseases. The ARAMIS-PMS program aims to study patients in normal clinical setting to evaluate the real-life effectiveness, toxicity, and cost effectiveness of various medications used to treat rheumatic diseases.

  3. Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.

    Science.gov (United States)

    Gama, Helena; Vieira, Mariana; Costa, Raquel; Graça, Joana; Magalhães, Luís M; Soares-da-Silva, Patrício

    2017-12-01

    Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015. From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at

  4. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Science.gov (United States)

    2011-08-16

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

  5. [Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

  6. Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

    Science.gov (United States)

    Silva, Ivair R

    2018-01-15

    Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. Copyright © 2017 John Wiley & Sons, Ltd.

  7. A post-marketing safety and efficacy assessment of a monoclonal antibody purified high-purity factor VIII concentrate.

    Science.gov (United States)

    Hay, C R; Lee, C A; Savidge, G

    1996-01-01

    The identification of infrequent side-effects of clotting factor concentrates, undetected by clinical trials, is facilitated by post-marketing surveillance. We present a post-marketing surveillance study in which 97 patients with haemophilia A, attending three haemophilia centres, were treated over a median follow-up period of 284 days (range 1-1074), and a total follow-up period of 30,080 days, with a pasteurized immunoaffinity purified factor VIII concentrate (Monoclate-P, Armour, Collegeville, USA). 5216 infusions, using 10,527,000 units of Monoclate-P, were carried out, mostly for routine haemarthroses or prophylaxis. No new inhibitors were observed during the study. At the start of the study 60/97 were HIV seropositive, 67/97 HBs antibody positive, 12 HbsAb negative and the remainder HBsAb positive before the study period. 13/14 tested were HAV seropositive at the beginning of the study. One patient became HAV seropositive during the study period, an infection thought to be community acquired. No other seroconversions were observed. Only one mild transfusion reaction was observed. This study confirms the safety and efficacy of Monoclate-P. Post-marketing surveillance or nationally organized pharmaco-vigilance should be practiced more widely to enable identification of low-frequency side-effects of treatment.

  8. 21 CFR 822.11 - What should I consider when designing my plan to conduct postmarket surveillance?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What should I consider when designing my plan to conduct postmarket surveillance? 822.11 Section 822.11 Food and Drugs FOOD AND DRUG ADMINISTRATION... Surveillance Plan § 822.11 What should I consider when designing my plan to conduct postmarket surveillance...

  9. National post-market surveillance assessment of veterinary medicines in Korea during the past decade.

    Science.gov (United States)

    Kang, JeongWoo; Park, Hae-Chul; Jang, Yang Ho; Hossain, Md Akil; Jeong, Kyunghun; Jeong, Mi Young; Yun, Seon-Jong; Park, Sung-Won; Kim, Dae Gyun; Lee, Kwang-Jick

    2017-05-22

    Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine. In this study, 1650 drugs for veterinary use were collected per year from each city and province in Korea and analysed for the quantity of active ingredients according to the "national post-market surveillance (NPMS) system" over the past decade. The NPMS assessment was performed using liquid and gas chromatography, titration, UV/Vis spectrophotometry, and bioassays. A total of 358 cases were deemed noncompliant, with the average noncompliance rate for all medicine types being 2.0%. The average noncompliance rates for antibiotics, biologics and other chemical drugs except antibiotics (OCD) were 1.1%, 1.2%, and 3.0%, respectively. The first leading cause for noncompliant products was insufficient quantity of major ingredients (283 cases), and the second leading cause was the existence of excess amount of active ingredients (60 cases). Tylosin, spiramycin, ampicillin, tetracyclines and penicillins were most frequently found to be noncompliant among antibiotics. Among the OCD, the noncompliance was found commonly in vitamin A. The overall trend presented gradually decreasing violation rates, suggesting that the quality of veterinary medicines has improved. Consistent application of the NPMS assessment and the establishment of the Korea Veterinary Good Manufacturing Practice (KVGMP) will help to maintain the good

  10. Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

    Science.gov (United States)

    Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

    2017-10-01

    This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

  11. Social Media Listening for Routine Post-Marketing Safety Surveillance.

    Science.gov (United States)

    Powell, Gregory E; Seifert, Harry A; Reblin, Tjark; Burstein, Phil J; Blowers, James; Menius, J Alan; Painter, Jeffery L; Thomas, Michele; Pierce, Carrie E; Rodriguez, Harold W; Brownstein, John S; Freifeld, Clark C; Bell, Heidi G; Dasgupta, Nabarun

    2016-05-01

    Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

  12. [Post-marketing drug safety-risk management plan(RMP)].

    Science.gov (United States)

    Ezaki, Asami; Hori, Akiko

    2013-03-01

    The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

  13. [Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring].

    Science.gov (United States)

    Guo, Xin-E; Zhao, Yu-Bin; Xie, Yan-Ming; Zhao, Li-Cai; Li, Yan-Feng; Hao, Zhe

    2013-09-01

    To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs). A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection. A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.

  14. Rethinking Research Ethics: The Case of Postmarketing Trials

    Science.gov (United States)

    London, Alex John; Carlisle, Benjamin

    2015-01-01

    Phase IV studies are often criticized for poor scientific standards. Yet they provide an important resource for addressing evidence shortfalls in drug safety, comparative effectiveness, and real-world utility. Current research ethics policies, and contemplated revisions to them, do not provide an adequate framework for preventing social harms that result from poor post-marketing research practice. Rather than focus exclusively on the welfare and interests of human volunteers, research policies and ethics should also safeguard the integrity of the research enterprise as a system for producing reliable medical evidence. We close by briefly describing how an integrity framework might be implemented for phase IV studies. PMID:22556237

  15. Brainstorming opportunities for postmarketing surveillance of chemicals : Workshop report

    NARCIS (Netherlands)

    Olthof ED; van Drongelen A; Graven C; Herremans J; de Kaste D; Ossendorp B; Piersma AH; GZB; V&Z

    2017-01-01

    On behalf of the Ministry of Health a survey was prepared of possibilities for setting up a 'post-marketing surveillance' (PMS)-system for chemical substances in consumer products, including food. With such a system, (long-term) health effects of substances which are already on the market may be

  16. A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records

    Directory of Open Access Journals (Sweden)

    Yamamoto K

    2011-04-01

    Full Text Available Keiichi Yamamoto1, Shigemi Matsumoto2, Kazuhiro Yanagihara2, Satoshi Teramukai1, Masanori Fukushima1,2,31Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan; 2Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan; 3Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, JapanPurpose: In conventional clinical studies, the cost of data management for the purposes of quality control tend to be high and collecting paper-based case report forms (CRFs can be burdensome, because paper-based CRFs must be developed and filled out for each clinical study protocol. Use of electronic health records (EHRs for this purpose could reduce costs and improve data quality in clinical studies. Kyoto University Hospital launched an EHR system in January 2005. At the same time, a replicate of that database was established for other purposes. At the Outpatient Oncology Unit of Kyoto University Hospital we developed a data-capture system that includes a cancer clinical database system and a data warehouse for outcomes studies. This system allows us to accumulate data at low cost and apply it to various uses in clinical or outcomes studies. Here we report on the application of this system to the post-marketing surveillance of drugs.Methods: We evaluated the availability of this system and identified problems for future development. With this system investigators can register cases for post-marketing surveillance, and the registered cases are listed on a screen. When CRFs for a particular case are required, data can be extracted from the list and CRFs are produced in PDF format.Results and conclusion: In this study we confirmed the applicability of our new system to post-marketing surveillance in providing prompt and efficient data exchange. We expect it to reduce the cost of data management and analysis and to improve the quality of data in post-marketing

  17. A post-marketing study of gadodiamide hydrate in patients with cerebral infarction

    International Nuclear Information System (INIS)

    Ono, Yuko; Aoki, Shigeki

    2003-01-01

    We evaluated the efficacy and safety of gadodiamide hydrate (GH: Omuniscan) in patients with cerebral infarction in a multicenter post-marketing study. A total of 122 patients enrolled in this study at 16 institutions in throughout Japan. We administrated GH to patients intravenously at 0.2 mL/kg, an approved usage and dosage for head MRI. Efficacy was evaluated by comparing contrast intensity and diagnostic improvement on T1WI before and after the administration of GH and diagnostic significance was investigated. Moreover, clinical data thus obtained were compared with those of phase III studies of GH and other contrast agents with respect to general evaluation of diagnostic improvement. The effects of contrast enhancement on the detection and extent of lesions as well as image quality were judged in terms of improving general evaluation and diagnosis, which was observed in 93.3% of the patients. No serious adverse event were associated with GH administration. The efficacy of GH in this clinical trial was higher, than historical data, with respect to general evaluation and diagnostic improvement. Contrast enhanced MRI with GH in cerebral infarction was confirmed to be of diagnostic value. (author)

  18. Recommendations for postmarketing surveillance studies in haemophilia and other bleeding disorders.

    Science.gov (United States)

    Lassila, R; Rothschild, C; De Moerloose, P; Richards, M; Perez, R; Gajek, H

    2005-07-01

    Prospective surveillance studies to monitor drug safety in the postapproval period are rarely employed systematically, although they are of greatest value for caregivers, drug users and regulatory authorities. Safety issues have affected not only conventional pharmaceuticals, but also especially coagulation factors in haemophilia treatment. The reputation of postmarketing surveillance (PMS) studies has been questionable, mainly due to their misuse to solicit prescriptions. Other weaknesses include inappropriate design, lack of standardized observation, limited follow-up periods, absence of rigour in identifying potential adverse drug effects, and infrequent publication. Although well-designed clinical trials represent the gold standard for generating sound clinical evidence, a number of aspects would make PMS studies valuable, if properly conducted. One of their main advantages is broader inclusion, and absence of an 'experimental' design. Lack of proper guidelines, and standardization may constitute a reason for the generally low quality of PMS studies. This paper proposes guidelines for haemophilia-specific PMS studies, in order to improve the acceptance of a basically valuable tool. In the absence of consistent regulatory guidance it will be especially important that the design and supervision of PMS studies involves physicians from the beginning. This will not only make such studies more scientifically relevant, but also help to implement them into daily clinical practice. Specifically in haemophilia, PMS studies may provide valuable data on clinical outcomes, or Quality of Life, which is of great importance when considering adequate standards of care in haemophilia patients.

  19. [Study on building index system of risk assessment of post-marketing Chinese patent medicine based on AHP-fuzzy neural network].

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming; Fu, Yingkun

    2011-10-01

    Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.

  20. [Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

    Science.gov (United States)

    Ma, Li-xin; Wang, Yu-yi; Li, Xin-xue; Liu, Jian-ping

    2012-03-01

    Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report

  1. Dalfampridine extended release tablets: 1 year of postmarketing safety experience in the US

    Directory of Open Access Journals (Sweden)

    Jara M

    2013-03-01

    Full Text Available Michele Jara,1 Graham Barker,2 Herbert R Henney 3rd1 1Acorda Therapeutics, Inc, Ardsley, NY, USA; 2Biogen Idec, Inc, Maidenhead, Berkshire, UK Background: Dalfampridine extended release tablets (dalfampridine-ER; prolonged-, modified, or sustained-release fampridine in some countries were approved in the US to improve walking in patients with multiple sclerosis, as demonstrated by improvement in walking speed. Postmarketing safety experience is available from exposure of approximately 46,000 patients in the US from product approval through March 2011. Objective: To provide a descriptive analysis of all spontaneously reported postmarketing adverse events (AEs for dalfampridine-ER since product launch. Methods: AE data were extracted from the safety database from product launch through March 31, 2011; AEs were classified using the Medical Dictionary for Regulatory Activities. Seizure cases were reviewed for patient demographics, time to event from treatment onset, and presence of additional risk factors. Results: The most frequently reported postmarketing AEs were similar to those reported during clinical development: dizziness, insomnia, balance disorder, headache, nausea, urinary tract infection, asthenia, and back pain (all included in US product labeling. New clinically significant findings are related to lack of efficacy and inappropriate dosing. Of the approximately 46,000 patients exposed, 85 seizures were reported (~5.4/1000 patient-years, of which 82 were reported or confirmed by a health care practitioner (~5.2/1000 patient-years. Beyond the intrinsic multiple sclerosis-related seizure risk, more than half of the 85 cases (62% had an additional potential risk factor for seizure including a previous history of convulsions, renal impairment, incorrect dosing, or use of concurrent medications with a labeled seizure risk. Duration of treatment prior to the seizure ranged from one dose to 365 days; 26/85 (31% patients suffered a seizure

  2. 21 CFR 822.28 - If I stop marketing the device subject to postmarket surveillance, what must I do?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false If I stop marketing the device subject to postmarket surveillance, what must I do? 822.28 Section 822.28 Food and Drugs FOOD AND DRUG ADMINISTRATION... of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what...

  3. Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post-marketing study (J-STEP/EL Study).

    Science.gov (United States)

    Utsunomiya, Kazunori; Shimmoto, Naoki; Senda, Masayuki; Kurihara, Yuji; Gunji, Ryoji; Fujii, Shoko; Kakiuchi, Seigo; Fujiwara, Hisataka; Kameda, Hiroyuki; Tamura, Masahiro; Kaku, Kohei

    2017-11-01

    Although sodium-glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus. This was a prospective, observational and multicenter post-marketing study carried out in the context of routine clinical practice. The study included all type 2 diabetes patients aged ≥65 years who started treatment with tofogliflozin during the first 3 months after its launch on 23 May 2014. Of 1,535 patients registered, 1,507 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis. A total of 270 of 1,507 patients (17.92%) had at least one adverse drug reaction to tofogliflozin. The incidences of adverse drug reactions of special interest, namely, polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, hypoglycemia and skin disorders were 2.92, 3.85, 2.06, 1.33, 1.06 and 2.39%, respectively. Among those patients evaluable for clinical effectiveness, the mean change in glycated hemoglobin and bodyweight from baseline to last visit was -0.46% (P < 0.0001) and -2.71 kg (P < 0.0001), respectively. The present study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ≥65 years differed little from the incidence in the preapproval clinical trials. It was shown that tofogliflozin significantly decreased glycated hemoglobin levels. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  4. [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    Science.gov (United States)

    Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

    2008-03-01

    Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

  5. Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

    Science.gov (United States)

    Mathieu, Chantal; Kozlovski, Plamen; Paldánius, Päivi M; Foley, James E; Modgill, Vikas; Evans, Marc; Serban, Carmen

    2017-08-01

    Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.

  6. A Postmarket Surveillance Study on Electro-Neuro-Adaptive-Regulator Therapy

    Directory of Open Access Journals (Sweden)

    Rod P. Bonello

    2014-01-01

    Full Text Available The Electro-Neuro-Adaptive-Regulator (ENAR device is a hand-held electrotherapy which is applied using energetic medicine principles and aspects of acupuncture theory. The aim of this paper is to report the findings of a postmarket survey of persons who have used the ENAR device. The conditions for which the therapy was used and its perceived effectiveness are discussed. A web-based survey of Australian recipients of ENAR therapy was completed by 481 respondents. Most (76% used ENAR exclusively for pain relief for musculoskeletal disorders, especially back, shoulder, and neck pain; 8% used ENAR exclusively for nonmusculoskeletal disorders; while 16% used ENAR for both. Respondents reported a mean reduction in pain of 70% (t(423 = 38.73, P<.001 and functional improvement of 62% (t(423 = 10.45, P<.001 using 11-point numerical rating scales. Following ENAR treatment, medication reduction was reported by 91% of respondents. Most respondents reported high satisfaction following ENAR therapy, with between 15 and 20% achieving complete pain relief. The self-delivery of ENAR may, in part, account for the high level of satisfaction.

  7. An Ethical Justification for Expanding the Notion of Effectiveness in Vaccine Post-Market Monitoring: Insights from the HPV Vaccine in Canada.

    Science.gov (United States)

    Komparic, Ana; Smith, Maxwell J; Thompson, Alison

    2016-04-01

    Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public's health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to be expanded in two ways to reflect a 'public health notion of post-market effectiveness', which incorporates normative public health considerations: (i) effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and (ii) the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize (and minimize) a vaccine's effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense.

  8. Drug- and herb-induced liver injury: Progress, current challenges and emerging signals of post-marketing risk.

    Science.gov (United States)

    Raschi, Emanuel; De Ponti, Fabrizio

    2015-07-08

    Drug-induced liver injury (DILI) and herb-induced liver injury is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications in the past 15 years. This review will first provide clues for clinicians to suspect idiosyncratic (unpredictable) DILI and succeed in diagnosis. Causality assessment remains challenging and requires careful medical history as well as awareness of multifaceted aspects, especially for herbs. Drug discontinuation and therapy reconciliation remain the mainstay in patent's management to minimize occurrence of acute liver failure. The second section will address novel agents associated with liver injury in 2014 (referred to as "signals"), especially in terms of clinical, research and drug development implications. Insights will be provided into recent trends by highlighting the contribution of different post-marketing data, especially registries and spontaneous reporting systems. This literature scrutiny suggests: (1) the importance of post-marketing databases as tools of clinical evidence to detect signals of DILI risk; and (2) the need for joining efforts in improving predictivity of pre-clinical assays, continuing post-marketing surveillance and design ad hoc post-authorization safety studies. In this context, ongoing European/United States research consortia and novel pharmaco-epidemiological tools (e.g., specialist prescription event monitoring) will support innovation in this field. Direct oral anticoagulants and herbal/dietary supplements appear as key research priorities.

  9. [Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments)].

    Science.gov (United States)

    Xie, Yan-Ming; Zhao, Yu-Bin; Jiang, Jun-Jie; Chang, Yan-Peng; Zhang, Wen; Shen, Hao; Lu, Peng-Fei

    2013-09-01

    Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.

  10. Monitoring product safety in the postmarketing environment.

    Science.gov (United States)

    Sharrar, Robert G; Dieck, Gretchen S

    2013-10-01

    The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

  11. Identifying optimal postmarket surveillance strategies for medical and surgical devices: implications for policy, practice and research.

    Science.gov (United States)

    Gagliardi, Anna R; Umoquit, Muriah; Lehoux, Pascale; Ross, Sue; Ducey, Ariel; Urbach, David R

    2013-03-01

    Non-drug technologies offer many benefits, but have been associated with adverse events, prompting calls for improved postmarket surveillance. There is little empirical research to guide the development of such a system. The purpose of this study was to identify optimal postmarket surveillance strategies for medical and surgical devices. Qualitative methods were used for sampling, data collection and analysis. Stakeholders from Canada and the USA representing different roles and perspectives were first interviewed to identify examples and characteristics of different surveillance strategies. These stakeholders and others they recommended were then assembled at a 1-day nominal group meeting to discuss and prioritise the components of a postmarket device surveillance system, and research needed to achieve such a system. Consultations were held with 37 participants, and 47 participants attended the 1-day meeting. They recommended a multicomponent system including reporting by facilities, clinicians and patients, supported with some external surveillance for validation and real-time trials for high-risk devices. Many considerations were identified that constitute desirable characteristics of, and means by which to implement such a system. An overarching network was envisioned to broker linkages, establish a shared minimum dataset, and support communication and decision making. Numerous research questions were identified, which could be pursued in tandem with phased implementation of the system. These findings provide unique guidance for establishing a device safety network that is based on existing initiatives, and could be expanded and evaluated in a prospective, phased fashion as it was developed.

  12. Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance.

    Science.gov (United States)

    Walter, Jessica R; Ghobadi, Comeron W; Hayman, Emily; Xu, Shuai

    2017-01-01

    In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk-benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.

  13. Safety and Effectiveness of Mirabegron in Patients with Overactive Bladder Aged ≥75 Years: Analysis of a Japanese Post-Marketing Study.

    Science.gov (United States)

    Yoshida, Masaki; Nozawa, Yumiko; Kato, Daisuke; Tabuchi, Hiromi; Kuroishi, Kentarou

    2017-09-12

    A 12-week post-marketing study was conducted to provide real-world data on Japanese patients with overactive bladder (OAB) initiating treatment with mirabegron. This post-hoc analysis focused on safety and effectiveness of mirabegron in patients aged ≥75 versus Similar changes were observed for I-PSS QoL in both groups. In a real-world clinical setting, mirabegron was well-tolerated and effective in patients aged ≥75 and <75 years. © 2017 John Wiley & Sons Australia, Ltd.

  14. Preclinical, clinical, and over-the-counter postmarketing experience with a new vaginal cup: menstrual collection.

    Science.gov (United States)

    North, Barbara B; Oldham, Michael J

    2011-02-01

    Menstrual cups have been available for decades, but their use is limited by bulky design and the need for multiple sizes. The Softcup® (Instead, Inc., San Diego, CA) is a simple single-size disposable over-the-counter (OTC) menstrual cup that compresses to tampon shape to facilitate insertion and can be worn during coitus. This report describes preclinical evaluation, clinical testing, and postmarketing monitoring of the Softcup. Preclinical testing complied with U.S. Food and Drug Administration (FDA) guidelines and used standard United States Pharmacopoeia methodologies for assessment of potential toxicity. Clinical testing enrolled 406 women in seven U.S. centers. A detailed written questionnaire assessed safety, acceptability, and effectiveness for menstrual collection. Study safety parameters included pelvic examinations, Pap smears, colposcopy, urinalysis, vaginal pH, wet mounts, gram stain, and vaginal microflora cultures. Postmarketing surveillance of over 100 million Softcups has been conducted by the manufacturer and by the FDA Medwatch system. No toxicity or mutagenicity was observed in preclinical evaluations. In clinical testing, after three cycles of cup use, 37% of subjects rated the cup as better than, 29% as worse than, and 34% as equal to pads or tampons. The cup was preferred for comfort, dryness, and less odor. Cups received lower ratings for disposal and convenience. Eighty-one percent of enrolled women were able to insert and remove their first cup using only written instructions. Use difficulties resulting in study discontinuations included cramping (1%), leakage (1%), and improper fit (3%). No safety parameters were adversely affected. No significant health risks were reported during postmarketing surveillance. These results demonstrate that a single-size vaginal device has no significant health risks and is acceptable to many women without the need for fitting or other medical services.

  15. Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China.

    Science.gov (United States)

    Guo, Biao; Page, Andrew; Wang, Huaqing; Taylor, Richard; McIntyre, Peter

    2013-01-11

    China is the most populous country in the world, with an annual birth cohort of approximately 16 million, requiring an average of 500 million vaccine doses administered annually. In China, over 30 domestic and less than 10 overseas vaccine manufacturers supply over 60 licensed vaccine products, representing a growing vaccine market mainly due to recent additions to the national immunization schedule, but data on post-marketing surveillance for adverse events following immunization (AEFI) are sparse. To compare reporting rates for various categories of AEFI from China with other routine post-marketing surveillance programs internationally. Systematic review of published studies reporting rates of AEFI by vaccine, category of reaction and age from post-marketing surveillance systems in English and Chinese languages. Overall AEFI reporting rates (all vaccines, all ages) in Chinese studies were consistent with those from similar international studies elsewhere, but there was substantial heterogeneity in regional reporting rates in China (range 2.3-37.8/100,000 doses). The highest AEFI reporting rates were for diphtheria-tetanus-pertussis whole-cell (DTwP) and acellular (DTaP) vaccines (range 3.3-181.1/100,000 doses for DTwP; range 3.5-92.6/100,000 doses for DTaP), with higher median rates for DTwP than DTaP, and higher than expected rates for DTaP vaccine. Similar higher rates for DTwP and DTaP containing vaccines, and relatively lower rates for vaccines against hepatitis B virus, poliovirus, and Japanese encephalitis virus were found in China and elsewhere in the world. Overall AEFI reporting rates in China were consistent with similar post-marketing surveillance systems in other countries. Sources of regional heterogeneity in AEFI reporting rates, and their relationships to differing vaccine manufacturers versus differing surveillance practices, require further exploration. Copyright © 2012 Elsevier Ltd. All rights reserved.

  16. Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

    Science.gov (United States)

    Cohen, Stanley; Curtis, Jeffrey R; DeMasi, Ryan; Chen, Yan; Fan, Haiyun; Soonasra, Arif; Fleischmann, Roy

    2018-06-01

    Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest were reviewed and reporting rates (RRs) were calculated by dividing the number of SAEs by the estimated 100 patient-years of exposure. Patient exposure was calculated based on estimated worldwide sales and an estimated daily regimen of tofacitinib 5 mg twice daily. During the 3-year reporting period, worldwide post-marketing exposure to tofacitinib since approval was estimated to be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac disorders, and 0.12 for hepatobiliary disorders. Although there are limitations to these data, no new safety risks were revealed in this real-world setting compared with the safety profile identified in the tofacitinib RA clinical development program. Any risks identified through the tofacitinib development program and PMS will continue to be monitored through pharmacovigilance surveillance. Pfizer Inc.

  17. Safety and effectiveness of rapid-acting intramuscular olanzapine for agitation associated with schizophrenia – Japan postmarketing surveillance study

    Directory of Open Access Journals (Sweden)

    Katagiri H

    2018-01-01

    Full Text Available Hideaki Katagiri,1 Masanori Taketsuna,2 Shinpei Kondo,3 Kenta Kajimoto,4 Etsuko Aoi,5 Yuka Tanji1 1Bio Medicine, 2Statistical Sciences, 3Post Marketing Study Management, 4Scientific Communications, Medicines Development Unit Japan, 5Global Patient Safety Japan, Quality and Patient Safety, Eli Lilly Japan K.K., Kobe, Japan Objective: The objective of this study was to evaluate the safety and effectiveness of rapid-acting intramuscular (IM olanzapine in the treatment of acute agitation associated with schizophrenia in real-world clinical settings in Japan.Methods: In this multicenter, postmarketing surveillance (PMS study, patients with acute agitation associated with schizophrenia were treated with IM olanzapine daily in a daily clinical setting. The observational period ranged from 1 to 7 days, including the day of initial administration. Safety was assessed by reporting treatment-emergent adverse events (TEAEs and adverse drug reactions (ADRs. The Positive and Negative Syndrome Scale – Excited Component (PANSS-EC score was used to evaluate effectiveness at baseline and at 2 hours (after each administration, 2 days, and 3 days (end of the observational period from the last administration of the IM olanzapine injection.Results: The safety analysis set included 999 patients, and the initial dose of 10 mg was administered to 955 patients. TEAEs were reported in 28 patients (36 events, the most common of which were dyslalia (5 patients, akathisia and somno­lence (4 patients each, hepatic function abnormal (3 patients, and constipation and dehydration (2 patients each. One serious adverse event of akathisia occurred during the observation period. The PANSS-EC score (mean ± standard deviation was 23.3±6.4 (n=625 at baseline, 16.9±7.0 (n=522 at 2 hours after initial injection, and 14.9±6.5 (n=650 at the last observation carried forward.Conclusion: The results of this Japanese PMS study demonstrated that IM olanzapine is safe and has a

  18. Effectiveness and tolerability of parenteral testosterone undecanoate: a post-marketing surveillance study.

    Science.gov (United States)

    Wolf, Jan; Keipert, Dieter; Motazedi, Heiko; Ernst, Michael; Nettleship, Joanne; Gooren, Louis

    2017-12-01

    This observational post-marketing study of parenteral testosterone undecanoate (TU) in a non-selected population aimed to: examine the effectiveness of TU as treatment of hypogonadism; record adverse drug reactions (ADR) quantitatively particularly regarding polycythemia, prostate safety and cardiovascular-related metabolic risk factors; and verify whether recommended injection intervals apply to routine clinical practice. Eight hundred and seventy subjects from 259 outpatient units scheduled to visit the clinic six times were included. Effectiveness and tolerability of TU administration were assessed on a 4-point scale. Body weight, waist girth, blood pressure, hemoglobin levels, hematocrit, prostate-specific antigen (PSA), and digital rectal prostate examination were assessed. Over 90% of subjects completed the observational duration of 52.8 ± 9.7 weeks (mean ± SD) and 56% judged effectiveness as very good, 30.8% as good. 63.1% judged tolerability as very good, and 24.4% as good. No adverse effects on indicators of cardiovascular risk were observed. Polycythemia occurred in one subject and a supranormal hematocrit in one subject. Four subjects developed supranormal PSA levels. Prostate carcinoma was found in one subject, one subject had recurrence of a previously surgically treated prostate carcinoma, and the other two showed no indication of malignancy. Parenteral TU is safe, effective, and well-tolerated in clinical practice proving a good therapeutic option for hypogonadism.

  19. Fingolimod Treatment in Relapsing-Remitting Multiple Sclerosis Patients: A Prospective Observational Multicenter Postmarketing Study

    Directory of Open Access Journals (Sweden)

    Rocco Totaro

    2015-01-01

    Full Text Available Objective. The aim of this prospective observational multicenter postmarketing study was to evaluate fingolimod efficacy in a real world clinical setting. Methods. One hundred forty-two subjects with relapsing-remitting multiple sclerosis (RRMS were enrolled in three multiple sclerosis centers throughout Central and Southern Italy between January 2011 and September 2013. After enrollment, regular visits and EDSS assessment were scheduled every 3 months, and MRI scan was obtained every 12 months. Patients were followed up from 1 to 33 months (mean 14.95 ± 9.15 months. The main efficacy endpoints included the proportion of patients free from clinical relapses, from disability progression, from magnetic resonance imaging activity, and from any disease activity. Results. Out of 142 patients enrolled in the study, 88.1% were free from clinical relapse and 69.0% were free from disability progression; 68.5% of patients remained free from new or newly enlarging T2 lesions and 81.7% of patients were free from gadolinium enhancing lesions. Overall the proportion of patients free from any disease activity was 41.9%. Conclusions. Our data in a real world cohort are consistent with previous findings that yield convincing evidence for the efficacy of fingolimod in patients with RRMS.

  20. Optimal implantation depth and adherence to guidelines on permanent pacing to improve the results of transcatheter aortic valve replacement with the medtronic corevalve system: The CoreValve prospective, international, post-market ADVANCE-II study

    NARCIS (Netherlands)

    A.S. Petronio (Anna); J.-M. Sinning (Jan-Malte); N.M. van Mieghem (Nicolas); G. Zucchelli (Giulio); G. Nickenig (Georg); R. Bekeredjian (Raffi); J. Bosmans (Johan); F. Bedogni (Francesco); M. Branny (Marian); K. Stangl (Karl); J. Kovac (Jan); M. Schiltgen (Molly); S. Kraus (Stacia); P.P.T. de Jaegere (Peter)

    2015-01-01

    textabstractObjectives The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis,

  1. 77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...

    Science.gov (United States)

    2012-08-30

    ... Contact Person) no later than September 5, 2012. No commercial or promotional material will be permitted... develop and implement a comprehensive medical device postmarket surveillance strategy to collect, analyze... implementing this strategy, FDA is holding a public meeting to discuss the current and future state of medical...

  2. [Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

    Science.gov (United States)

    Liu, Huan; Xie, Yanming

    2011-10-01

    The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

  3. Herpes zoster vaccine live: A 10 year review of post-marketing safety experience.

    Science.gov (United States)

    Willis, English D; Woodward, Meredith; Brown, Elizabeth; Popmihajlov, Zoran; Saddier, Patricia; Annunziato, Paula W; Halsey, Neal A; Gershon, Anne A

    2017-12-19

    Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Safety of hexaminolevulinate for blue light cystoscopy in bladder cancer. A combined analysis of the trials used for registration and postmarketing data

    NARCIS (Netherlands)

    Witjes, J.A.; Gomella, L.G.; Stenzl, A.; Chang, S.S.; Zaak, D.; Grossman, H.B.

    2014-01-01

    OBJECTIVE: To detail and put into perspective, safety of hexaminolevulinate blue light cystoscopy (HAL-BLC), including repeated use, based on combined data of controlled trials used for registration of HAL and postmarketing experience. METHODS: Safety data of 2 randomized comparative studies (group

  5. Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

    Science.gov (United States)

    Stollenwerk, Ariane; Sohns, Melanie; Heisig, Fabian; Elling, Christian; von Zabern, Detlef

    2018-01-01

    Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population. Grünenthal GmbH.

  6. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    Science.gov (United States)

    Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

  7. Post-market drug evaluation research training capacity in Canada: an environmental scan of Canadian educational institutions.

    Science.gov (United States)

    Wiens, Matthew O; Soon, Judith A; MacLeod, Stuart M; Sharma, Sunaina; Patel, Anik

    2014-01-01

    Ongoing efforts by Health Canada intended to modernize the legislation and regulation of pharmaceuticals will help improve the safety and effectiveness of drug products. It will be imperative to ensure that comprehensive and specialized training sites are available to train researchers to support the regulation of therapeutic products. The objective of this educational institution inventory was to conduct an environmental scan of educational institutions in Canada able to train students in areas of post-market drug evaluation research. A systematic web-based environmental scan of Canadian institutions was conducted. The website of each university was examined for potential academic programs. Six core programmatic areas were determined a priori as necessary to train competent post-market drug evaluation researchers. These included biostatistics, epidemiology, pharmacoepidemiology, health economics or pharmacoeconomics, pharmacogenetics or pharmacogenomics and patient safety/pharmacovigilance. Twenty-three academic institutions were identified that had the potential to train students in post-market drug evaluation research. Overall, 23 institutions taught courses in epidemiology, 22 in biostatistics, 17 in health economics/pharmacoeconomics, 5 in pharmacoepidemiology, 5 in pharmacogenetics/pharmacogenomics, and 3 in patient safety/pharmacovigilance. Of the 23 institutions, only the University of Ottawa offered six core courses. Two institutions offered five, seven offered four and the remaining 14 offered three or fewer. It is clear that some institutions may offer programs not entirely reflected in the nomenclature used for this review. As Heath Canada moves towards a more progressive licensing framework, augmented training to increase research capacity and expertise in drug safety and effectiveness is timely and necessary.

  8. Construction and analysis of a human hepatotoxicity database suitable for QSAR modeling using post-market safety data

    International Nuclear Information System (INIS)

    Zhu, Xiao; Kruhlak, Naomi L.

    2014-01-01

    Graphical abstract: - Abstract: Drug-induced liver injury (DILI) is one of the most common drug-induced adverse events (AEs) leading to life-threatening conditions such as acute liver failure. It has also been recognized as the single most common cause of safety-related post-market withdrawals or warnings. Efforts to develop new predictive methods to assess the likelihood of a drug being a hepatotoxicant have been challenging due to the complexity and idiosyncrasy of clinical manifestations of DILI. The FDA adverse event reporting system (AERS) contains post-market data that depict the morbidity of AEs. Here, we developed a scalable approach to construct a hepatotoxicity database using post-market data for the purpose of quantitative structure–activity relationship (QSAR) modeling. A set of 2029 unique and modelable drug entities with 13,555 drug-AE combinations was extracted from the AERS database using 37 hepatotoxicity-related query preferred terms (PTs). In order to determine the optimal classification scheme to partition positive from negative drugs, a manually-curated DILI calibration set composed of 105 negatives and 177 positives was developed based on the published literature. The final classification scheme combines hepatotoxicity-related PT data with supporting information that optimize the predictive performance across the calibration set. Data for other toxicological endpoints related to liver injury such as liver enzyme abnormalities, cholestasis, and bile duct disorders, were also extracted and classified. Collectively, these datasets can be used to generate a battery of QSAR models that assess a drug's potential to cause DILI

  9. Results of a customer-based, post-market surveillance survey of the HeRO access device.

    Science.gov (United States)

    Fusselman, Maureen

    2010-08-01

    In order to supplement post-market surveillance data on the HeRO vascular access device, a non-scientific customer survey was conducted to obtain quantitative data from dialysis providers caring for patients implanted with the device. Dialysis nurses involved in the care of HeRO patients were contacted in order to obtain post-implant device performance information for 10% of patients implanted with the device at the time of the survey. Thirty-eight dialysis units with a total of 65 HeRO patients participated in the survey. The total duration of HeRO device use was 348.4 months with an average use of 5.4 months. Thirty-eight of the 65 HeRO patients (58.5%) were reported to not have experienced any performance issues. There were 28 device performance incidents reported for the remaining 27 patients included in the survey. Occlusion was the single most commonly reported device-related performance issue with 18 patients (27.7%) experiencing 25 occlusive episodes. The majority of the patients who had an occlusion (66.7%) only experienced one occlusive event. Infections occurred in 4 patients (6.2%) with an overall infection rate of 0.38 per 1,000 patient days. Post-market clinical experience during the first 18 months of commercialization of the HeRO device were in line with expectations based on the results from initial clinical studies with the device. Device occlusion remains the most commonly reported performance issue with the reported rate in this survey less than that which was reported in earlier published studies with the device.

  10. Impact of Chronic Renal Failure on Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Artery Disease: Subgroup Analysis from Zilver PTX Post-Market Surveillance Study in Japan.

    Science.gov (United States)

    Ogawa, Yukihisa; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Saunders, Alan T; Dake, Michael D

    2017-11-01

    Favorable long-term outcomes of the Zilver PTX drug-eluting stent (DES) in femoropopliteal lesions have been demonstrated. Chronic renal failure (CRF) has been shown to be a risk factor for restenosis and decreased limb salvage. The results of the DES in patients with CRF have not previously been reported. This study compares the results with the DES in patients with CRF and those without CRF. This retrospective analysis from the Zilver PTX Japan Post-Market Surveillance Study included 321 patients with CRF and 584 patients without CRF. Outcomes included freedom from target lesion revascularization (TLR) and patency. Of the patients included in this subgroup analysis, 2-year data were available for 209 patients in the CRF group and 453 patients in the non-CRF group. The two groups were similar in terms of lesion length and the frequency of in-stent restenosis. Critical limb ischemia, severe calcification, and diabetes were more common in patients with CRF, whereas total occlusion was more common in patients without CRF. Freedom from TLR rates were 81.4 versus 84.9% (p = 0.24), and patency rates were 70.7 versus 70.3% (p = 0.95) in patients with and without CRF at 2 years, respectively. This is the first comparative study of the DES in femoropopliteal artery lesions in patients with and without CRF. These results indicate that the DES placed in femoropopliteal artery lesions of CRF patients is safe and effective with similar patency and TLR rates to patients without CRF. Level 3, Post-Market Surveillance Study.

  11. Development, Production, and Postmarketing Surveillance of Hepatitis A Vaccines in China

    Science.gov (United States)

    Cui, Fuqiang; Liang, Xiaofeng; Wang, Fuzhen; Zheng, Hui; Hutin, Yvan J; Yang, Weizhong

    2014-01-01

    China has long experience using live attenuated and inactivated vaccines against hepatitis A virus (HAV) infection. We summarize this experience and provide recent data on adverse events after immunization (AEFIs) with hepatitis A vaccines in China. We reviewed the published literature (in Chinese and English) and the published Chinese regulatory documents on hepatitis A vaccine development, production, and postmarketing surveillance of AEFI. We described the safety, immunogenicity, and efficacy of hepatitis A vaccines and horizontal transmission of live HAV vaccine in China. In clinical trials, live HAV vaccine was associated with fever (0.4%–5% of vaccinees), rash (0%–1.1%), and elevated alanine aminotransferase (0.015%). Inactivated HAV vaccine was associated with fever (1%–8%), but no serious AEFIs were reported. Live HAV vaccine had seroconversion rates of 83% to 91%, while inactivated HAV vaccine had seroconversion rates of 95% to 100%. Community trials showed efficacy rates of 90% to 95% for live HAV and 95% to 100% for inactivated HAV vaccine. Postmarketing surveillance showed that HAV vaccination resulted in an AEFI incidence rate of 34 per million vaccinees, which accounted for 0.7% of adverse events reported to the China AEFI monitoring system. There was no difference in AEFI rates between live and inactivated HAV vaccines. Live and inactivated HAV vaccines manufactured in China were immunogenic, effective, and safe. Live HAV vaccine had substantial horizontal transmission due to vaccine virus shedding; thus, further monitoring of the safety of virus shedding is warranted. PMID:24681843

  12. Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance.

    Science.gov (United States)

    Izem, Rima; Sanchez-Kam, Matilde; Ma, Haijun; Zink, Richard; Zhao, Yueqin

    2018-03-01

    Safety data are continuously evaluated throughout the life cycle of a medical product to accurately assess and characterize the risks associated with the product. The knowledge about a medical product's safety profile continually evolves as safety data accumulate. This paper discusses data sources and analysis considerations for safety signal detection after a medical product is approved for marketing. This manuscript is the second in a series of papers from the American Statistical Association Biopharmaceutical Section Safety Working Group. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from passive postmarketing surveillance systems compared to other sources. Signal detection has traditionally relied on spontaneous reporting databases that have been available worldwide for decades. However, current regulatory guidelines and ease of reporting have increased the size of these databases exponentially over the last few years. With such large databases, data-mining tools using disproportionality analysis and helpful graphics are often used to detect potential signals. Although the data sources have many limitations, analyses of these data have been successful at identifying safety signals postmarketing. Experience analyzing these dynamic data is useful in understanding the potential and limitations of analyses with new data sources such as social media, claims, or electronic medical records data.

  13. Pediatric post-marketing safety systems in North America: assessment of the current status.

    Science.gov (United States)

    McMahon, Ann W; Wharton, Gerold T; Bonnel, Renan; DeCelle, Mary; Swank, Kimberley; Testoni, Daniela; Cope, Judith U; Smith, Phillip Brian; Wu, Eileen; Murphy, Mary Dianne

    2015-08-01

    It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use. We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety. Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples. Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics. Copyright © 2015 John Wiley & Sons, Ltd.

  14. In vitro and in vivo postmarketing surveillance of valsartan, alone or in combination with amlodipine or hydrochlorthiazide, among Palestinian hypertensive patients

    Directory of Open Access Journals (Sweden)

    Zaid AN

    2016-09-01

    Full Text Available Abdel Naser Zaid,1 Masshour Ghanem,2 Dua’a Shweiki,1 Hala Shtewi,1 Raja’ Shaheen,1 Sondos Al Helaly,1 Zeina Khayyat,1 Rowa’a Al Ramahi,1 Sa’ed H Zyoud1 1Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National University, Nablus, 2Pharmacare Ltd, Ramallah, Palestine Objectives: The objectives of this study were to evaluate the general quality of the most prescribed products of valsartan (VL; alone or in combination and to evaluate their efficacy and safety among Palestinian population through in vivo postmarketing surveillance. Patients and methods: The first part was pharmacopeial quality control assay, including dissolution, disintegration, friability, and weight uniformity for VL. The second part was a 3-month cardiology clinics, observational, postmarketing surveillance pilot study that included 103 hypertensive patients who were prescribed 80 mg or 160 mg of VL as monotherapy or combination therapy. The end points were reduction in blood pressure (BP and the rate of incidence of adverse effects (AEs at weeks 4 and 8. Results: According to our quality control tests, all VL products showed high-quality standards according to the international guidelines. A reduction in BP was observed at weeks 4 and 8, and no significant difference was observed between the strengths of 80 mg and 160 mg. Higher BP reduction was observed after the use of combination therapy. Moreover, VL was well tolerated; most of the AEs were of mild-to-moderate intensity. In general, the most frequently reported AEs included headache (17.5%, dizziness (11.75%, and weakness (11.7%. No serious AEs or death cases were reported during the study period. Conclusion: High quality of VL tablet products was used; hence, the observed efficacy and safety results should be related to patient’s factors and not due to any product defects or substandard quality. Moreover, VL is an effective treatment for essential hypertension. Keywords: valsartan

  15. Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch® capsules 2.5 μg in 3,762 hemodialysis patients with intractable pruritus

    Directory of Open Access Journals (Sweden)

    Kozono H

    2018-01-01

    Full Text Available Hideki Kozono,* Hiroshi Yoshitani,* Ryoko Nakano* Pharmaceutical and Medical Device Vigilance Department, Toray Industries, Inc., Tokyo, Japan *The authors contributed equally to this work Background: Intractable pruritus in hemodialysis patients can significantly decrease their quality of life and is also associated with poor vital prognosis. Although combined multiple causes of intractable pruritus in these patients have been identified, no existing treatments are proven to be sufficiently effective. We conducted a post-marketing surveillance to follow-up and assess the safety and efficacy of nalfurafine, a selective κ-opioid receptor agonist, for the treatment of intractable pruritus in patients undergoing hemodialysis. Patients and methods: Hemodialysis patients with intractable pruritus from institutions in Japan who received oral nalfurafine hydrochloride between January 2010 and December 2013 were enrolled in the surveillance. Surveillance was completed in July 2015. Safety data during 1 year after nalfurafine treatment onset, and efficacy data of nalfurafine evaluating the first 12-week treatment period and the following period until 1 year after the initial dose of nalfurafine (using global assessment of the itch improvement by the physician, Visual Analog Scale, and the Shiratori’s severity scores were collected and analyzed. Results: In total, 3,762 patients were analyzed for safety. Adverse drug reactions were experienced by 402/3,762 (10.69% patients. The most frequent adverse drug reactions were insomnia (127/3,762 [3.38%] patients, constipation (34 [0.90%], somnolence (32 [0.85%], dizziness (23 [0.61%], nausea (13 [0.35%], and malaise (9 [0.24%]. No patients developed dependence on nalfurafine. Nalfurafine was effective in 82.50% (2,880/3,491 of patients during the first 12 weeks and in 84.95% (2,167/2,551 on treatment during the subsequent period until 1 year after nalfurafine treatment initiation. Statistically significant

  16. Safety and efficacy of lansoprazole injection in upper gastrointestinal bleeding: a postmarketing surveillance conducted in Indonesia.

    Science.gov (United States)

    Syam, Ari F; Setiawati, Arini

    2013-04-01

    to assess the safety and effectiveness of lansoprazole injection (Prosogan®) in patients with upper gastrointestinal bleeding due to peptic ulcers or erosive gastritis. this study was a multicenter observational postmarketing study of lansoprazole (Prosogan®) injection. Patients with upper gastrointestinal bleeding due to peptic ulcers or erosive gastritis were given intravenous lansoprazole for a maximum of 7 days or until the bleeding stopped and the patients were able to take oral doses of lansoprazole. Primary outcome of the study was cessation of bleeding. Some laboratory parameters were also measured. among a total of 204 patients evaluable for safety, there was no adverse event reported during the study. A total of 200 patients were eligible for efficacy evaluation, 125 patients (62.5%) were males. Among these patients, upper GI bleeding stopped in 20 patients (10.0%) on day 1, in 71 patients (35.5%) on day 2, 75 patients (37.5%) on day 3, 24 patients (12.0%) on day 4, and 7 patients (3.5%) on day 5, making a cumulative of 197 patients (98.5%) on day 5. The hemostatic effect was rated as 'excellent' if the bleeding stopped within 3 days, and 'good' if the bleeding stopped within 5 days. Thus, the results were 'excellent' in 166 patients (83.0%) and 'good' in 31 patients (15.5%). These results were not different between males and females, between age below 60 years and 60 years and above, and between baseline Hb below 10 g/dL and 10 g/dL and above. the results of this observational postmarketing study in 200 patients with upper gastrointestinal bleeding due to peptic ulcers or erosive gastritis demonstrated that intravenous lansoprazole twice a day was well tolerated and highly effective.

  17. Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction

    Science.gov (United States)

    Nawroth, Frank; Tandler-Schneider, Andreas; Bilger, Wilma

    2015-01-01

    This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH) using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI) alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles ≥15 mm). Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population). The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%), 50.0 IU (n=1,056 from N=3,189; 33.1%), and 75.0 IU (n=738 from N=3,189; 23.1%) on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%), 50.0 IU (n=922 from N=3,189; 28.9%), and 75.0 IU (n=895 from N=3,189; 28.1%) on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU) of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI. PMID:25926755

  18. Safety and efficacy of adapalene gel 0.1% in acne vulgaris: Results of a post-marketing surveillance study

    Directory of Open Access Journals (Sweden)

    Percy S

    2003-07-01

    Full Text Available Introduction: Adapalene is a novel retinoid indicated for the topical treatment of acne vulgaris. The drug was introduced in India in 2001. Aims: A post-marketing surveillance study was conducted to assess the safety and efficacy of adapalene gel 0.1% when used as monotherapy or in combination with other anti-acne agents in Indian patients of acne vulgaris. Material and Methods: A 12-week, multicentre, open-label, non-comparative study involving 571 patients from 21 centers across India was conducted between January and September of 2002. Concomitant prescription of other anti-acne drugs was permitted, if needed. Results: Of the 571 patients, 441 completed the treatment as per protocol. At the end of therapy, 96.3% of patients showed an improvement in their acne from baseline, with greater than 75% improvement seen in two-thirds of patients. Adverse events were reported in 24% of the patients, none of which were serious. The tolerability of therapy was rated as excellent/good in 81% of patients by physicians and in 78% by the patients. Conclusion: Adapalene gel 0.1% is a safe and effective topical agent in the treatment of mild to moderate acne vulgaris in Indian patients. It may be safely combined with other topical and oral anti-acne agents.

  19. Determinants of persistence in hypertensive patients treated with irbesartan: results of a postmarketing survey

    Directory of Open Access Journals (Sweden)

    Greminger Peter

    2005-06-01

    Full Text Available Abstract Background Persistence is a key factor for long-term blood pressure control, which is of high prognostic importance for patients at increased cardiovascular risk. Here we present the results of a post-marketing survey including 4769 hypertensive patients treated with irbesartan in 886 general practices in Switzerland. The goal of this survey was to evaluate the tolerance and the blood pressure lowering effect of irbesartan as well as the factors affecting persistence in a large unselected population. Methods Prospective observational survey conducted in general practices in all regions of Switzerland. Previously untreated and uncontrolled pre-treated patients were started with a daily dose of 150 mg irbesartan and followed up to 6 months. Results After an observation time slightly exceeding 4 months, the average reduction in systolic and diastolic blood pressure was 20 (95% confidence interval (CI -19.6 to -20.7 mmHg and 12 mmHg (95% CI -11.4 to -12.1 mmHg, respectively. At this time, 26% of patients had a blood pressure Conclusion The results of this survey confirm that irbesartan is effective, well tolerated and well accepted by patients, as indicated by the good persistence. This post-marketing survey also emphasizes the importance of the tolerability profile and of achieving an early control of blood pressure as positive predictors of persistence.

  20. Safety profile of dalfampridine extended release in multiple sclerosis: 5-year postmarketing experience in the United States

    Directory of Open Access Journals (Sweden)

    Jara M

    2015-12-01

    Full Text Available Michele Jara, Thomas Aquilina, Peter Aupperle, Adrian L Rabinowicz Acorda Therapeutics, Inc., Ardsley, NY, USA Background: Dalfampridine extended release tablets (dalfampridine-ER; prolonged-, modified, or sustained-release fampridine outside the US, 10 mg twice daily, was approved by the US Food and Drug Administration (FDA in January 2010 to improve walking in people with multiple sclerosis, as determined by an increase in walking speed. Objective: To provide a descriptive analysis of reported adverse events (AEs for commercially available dalfampridine-ER from March 2010 through March 31, 2015. Methods: Five-year postmarketing data for dalfampridine-ER were available from the exposure of approximately 107,000 patients in the US (103,700 patient-years. Commonly reported AEs (≥2% of all reported AEs and serious AEs were determined. The incidence of reported seizures was determined and the events were further investigated. Results: Among the 107,000 patients exposed to dalfampridine-ER (70% female; mean age 52.1, the most common AEs were dizziness (3.7%, insomnia (3.2%, balance disorder (3%, fall (2.4%, headache (2.4%, nausea (2.1%, and urinary tract infection (2%. Other common AEs were drug ineffectiveness (5.8%, gait disturbance (4.6%, and inappropriate dosing (3.1%. Serious AEs included rare anaphylactic reactions (five cases and drug hypersensitivity reactions (eight cases. A total of 657 seizure cases were reported (6.3/1,000 patient-years; of these, 324 were medically confirmed (3.1/1,000 patient-years. Incidence of reported seizures was stable over time. Duration of treatment prior to a seizure ranged from a single dose to >4 years; 12% of the seizures occurred within a week of starting treatment. Conclusion: The 5-year US postmarketing safety data of dalfampridine-ER is consistent with the safety profile observed in clinical trials. Incidence of reported seizures remained stable over time. Since commercial availability in March 2010, a

  1. [Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

    Science.gov (United States)

    Wang, Gui-Qian; Gao, Yang; Liu, Fu-Mei; Wei, Rui-Li; Xie, Yan-Ming

    2018-02-01

    To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication. Copyright© by the Chinese Pharmaceutical Association.

  2. 21 CFR 822.24 - What are my responsibilities once I am notified that I am required to conduct postmarket...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What are my responsibilities once I am notified that I am required to conduct postmarket surveillance? 822.24 Section 822.24 Food and Drugs FOOD AND... SURVEILLANCE Responsibilities of Manufacturers § 822.24 What are my responsibilities once I am notified that I...

  3. Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

    Science.gov (United States)

    Yang, Yu; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yanming; Feng, Yuji; Huang, Kui; Zhan, Siyan

    2018-01-01

    Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards. All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively. These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

  4. Use of carabids for the post-market environmental monitoring of genetically modified crops

    Czech Academy of Sciences Publication Activity Database

    Skoková Habuštová, Oxana; Svobodová, Zdeňka; Cagáň, Ľ.; Sehnal, František

    2017-01-01

    Roč. 9, č. 4 (2017), č. článku 121. E-ISSN 2072-6651 R&D Projects: GA MŠk(CZ) 7AMB14SK096 Grant - others:projekt VEGA(SK) 1/0732/14; GA ČR(CZ) L200961652 Institutional support: RVO:60077344 Keywords : Carabidae * surrogate * post-market environmental monitoring Subject RIV: GF - Plant Pathology, Vermin, Weed, Plant Protection OBOR OECD: GM technology (crops and livestock), livestock cloning, marker assisted selection, diagnostics (DNA chips and biosensing devices for the early/accurate detection of diseases) biomass feedstock production technologies, biopharming Impact factor: 3.030, year: 2016 http://www.mdpi.com/2072-6651/9/4/121

  5. Postmarketing study of efficacy and safety of losartan during the treatment of patients with mild and moderate hypertension: Lothar study

    Directory of Open Access Journals (Sweden)

    Vasiljević Zorana

    2013-01-01

    Full Text Available Introduction. Losartan, the angiotensin type 1 receptor blocker (ARB exercises its main antihypertensive effect by vasodilatation of peripheral arteries. Objective. The aim of this study was to evaluate the antihypertensive effect and safety of losartan in patients with mild and moderate arterial hypertension (AH. Methods. This was an open post-marketing study with losartan as monotherapy in previously treated or untreated patients with AH. Primary efficacy parameter was the percentage of patients that achieved target blood pressure after 8-week treatment with a single daily dose of losartan of 50-100 mg. Safety parameters were assessed according to the percentage of adverse events and metabolic effects of therapy. Results. The study included 550 patients with AH (59% female and 41% male, mean age 56.8±11.4 years, BMI=27±4 kg/m2. Losartan was applied in 31% of untreated and 69% of previously treatment-resistant patients After 8 weeks target blood pressure was achieved in 67.8% (SBP and in 81.1% (DBP of patients, respectively. The mean decrease was 21.8% for SBP and 21.1% for DBP (p<0.001. Out of all, 65% of patients achieved both target SBP and DBP values. Hydrochlorothiazide was added to the therapy in 11.6% of patients. There were no significant differences in drug efficacy between the entire group and subgroups of patients with diabetes mellitus and impaired renal function (p=ns. Adverse events were rare and metabolic effect was favorable. Conclusion. Monotherapy with losartan in a dosage of 50-100 mg applied during 8 weeks resulted in achieving target values of blood pressure in 65% of patient with mild and moderate hypertension, also including the patients with diabetes mellitus and impaired renal function. Losartan is a safe and metabolically neutral medication.

  6. Itopride in the treatment of functional dyspepsia in Chinese patients: a prospective, multicentre, post-marketing observational study.

    Science.gov (United States)

    Sun, Jing; Yuan, Yao-Zong; Holtmann, Gerald

    2011-12-01

    Prokinetic agents are commonly used in the symptomatic treatment of functional dyspepsia (FD). Safety or efficacy issues associated with the use of available prokinetics, such as metoclopramide, domperidone, cisapride and mosapride, mean there is a need for an effective and well tolerated prokinetic agent. Itopride is a novel prokinetic agent with a dual mode of action, good safety profile and documented efficacy in placebo-controlled trials. The objective of this study was to assess the effectiveness and safety of itopride in the management of FD. This was a prospective, multicentre, post-marketing observational study carried out in private outpatient clinics throughout China. The study included patients with symptomatic FD aged ≥18 years. Patients were prescribed itopride 50 mg three times daily before meals for 4 weeks, after which there was a 2-week follow-up period during which they did not take itopride. Effectiveness and tolerability data obtained from patients who completed 4 weeks of therapy were analysed. The treatment response rate after 4 weeks was measured by patient global assessment; scores at the end of treatment were compared with baseline scores. Response rate based on symptom scoring was also measured after 4 weeks, with an effective treatment being defined as a symptom improvement of ≥50%. In total, 587 patients with FD were enrolled. The mean ± SD difference in the total symptom score before and after the 4-week treatment period was -5.62 ± 3.27, corresponding to a 69.23 ± 26.53% reduction from baseline (p Itopride was an effective and well tolerated drug in the management of FD in this patient population.

  7. A temporal interestingness measure for drug interaction signal detection in post-marketing surveillance.

    Science.gov (United States)

    Ji, Yanqing; Ying, Hao; Tran, John; Dews, Peter; Mansour, Ayman; Massanari, R Michael

    2014-01-01

    Drug-drug interactions (DDIs) can result in serious consequences, including death. Existing methods for identifying potential DDIs in post-marketing surveillance primarily rely on the FDA's (Food and Drug Administration) spontaneous reporting system. However, this system suffers from severe underreporting, which makes it difficult to timely collect enough valid cases for statistical analysis. In this paper, we study how to signal potential DDIs using patient electronic health data. Specifically, we focus on discovery of potential DDIs by analyzing the temporal relationships between the concurrent use of two drugs of interest and the occurrences of various symptoms using novel temporal association mining techniques we developed. A new interestingness measure called functional temporal interest was proposed to assess the degrees of temporal association between two drugs of interest and each symptom. The measure was employed to screen potential DDIs from 21,405 electronic patient cases retrieved from the Veterans Affairs Medical Center in Detroit, Michigan. The preliminary results indicate the usefulness of our method in finding potential DDIs for further analysis (e.g., epidemiology study) and investigation (e.g., case review) by drug safety professionals.

  8. Clinical safety and efficacy of "filgrastim biosimilar 2" in Japanese patients in a post-marketing surveillance study.

    Science.gov (United States)

    Tamura, Kazuo; Hashimoto, Kazue; Nishikawa, Kiyohiro

    2018-05-01

    We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5.26%). Back pain was most frequently observed and reported in 20 patients (3.19%), followed by pyrexia (1.28%) and bone pain (0.96%). Risk factors for adverse reactions identified by logistic regression analyses were younger age, presence of past medical history, and lower total dose at the onset of adverse reactions. Among the 576 cancer patients who developed Grade 2-4 neutropenia after chemotherapy, recovery to Grade 1/0 was reported in 553 patients (96%) following filgrastim biosimilar 2 treatment. The median duration of neutrophil counts below 1500/μL was 5 days. In addition, all 11 patients who underwent hematopoietic stem cell transplantation had good responses to filgrastim biosimilar 2. In conclusion, this study showed that filgrastim biosimilar 2 has a similar safety profile and comparable effects to the original G-CSF product in the real world clinical setting. Copyright © 2018 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  9. Efficacy and tolerability of rasagiline in daily clinical use--a post-marketing observational study in patients with Parkinson's disease.

    Science.gov (United States)

    Reichmann, H; Jost, W H

    2010-09-01

    The MAO-B inhibitor rasagiline is indicated for the treatment of idiopathic Parkinson's disease (PD), and its use is supported by evidence from large-scale, controlled clinical studies. The post-marketing observational study presented here investigated the efficacy and tolerability of rasagiline treatment (monotherapy or combination therapy) in daily clinical practice. The study included patients with idiopathic PD who received rasagiline (recommended dose 1 mg, once daily) as monotherapy or combination therapy. The treatment and observation period was approximately 4 months. Outcome measures included the change from baseline in the Columbia University Rating Scale (CURS), the Unified PD Rating Scale fluctuation subscale, daily OFF time (patient home diaries) and the PD Questionnaire-39. Adverse drug reactions/adverse events (ADRs/AEs) and the physician's global judgement of tolerability and efficacy were also examined. Overall, 754 patients received rasagiline during the study. Patients treated with rasagiline (monotherapy or combination therapy) showed significant improvements from baseline in symptom severity (including classical motor and non-classical motor/non-motor symptoms) and quality of life (QoL). Patients receiving combination therapy also experienced significant reductions in daily OFF time. Tolerability was rated as good/very good in over 90% of patients. In daily clinical practice, monotherapy or combination therapy with rasagiline is able to improve PD symptoms, reduce OFF time, and improve QoL, whilst demonstrating favourable tolerability. In addition, rasagiline has a simple dosing schedule of one tablet, once daily, with no titration. These results are consistent with the pivotal rasagiline clinical studies (TEMPO, LARGO and PRESTO).

  10. Orphan therapies: making best use of postmarket data.

    Science.gov (United States)

    Maro, Judith C; Brown, Jeffrey S; Dal Pan, Gerald J; Li, Lingling

    2014-08-01

    Postmarket surveillance of the comparative safety and efficacy of orphan therapeutics is challenging, particularly when multiple therapeutics are licensed for the same orphan indication. To make best use of product-specific registry data collected to fulfill regulatory requirements, we propose the creation of a distributed electronic health data network among registries. Such a network could support sequential statistical analyses designed to detect early warnings of excess risks. We use a simulated example to explore the circumstances under which a distributed network may prove advantageous. We perform sample size calculations for sequential and non-sequential statistical studies aimed at comparing the incidence of hepatotoxicity following initiation of two newly licensed therapies for homozygous familial hypercholesterolemia. We calculate the sample size savings ratio, or the proportion of sample size saved if one conducted a sequential study as compared to a non-sequential study. Then, using models to describe the adoption and utilization of these therapies, we simulate when these sample sizes are attainable in calendar years. We then calculate the analytic calendar time savings ratio, analogous to the sample size savings ratio. We repeat these analyses for numerous scenarios. Sequential analyses detect effect sizes earlier or at the same time as non-sequential analyses. The most substantial potential savings occur when the market share is more imbalanced (i.e., 90% for therapy A) and the effect size is closest to the null hypothesis. However, due to low exposure prevalence, these savings are difficult to realize within the 30-year time frame of this simulation for scenarios in which the outcome of interest occurs at or more frequently than one event/100 person-years. We illustrate a process to assess whether sequential statistical analyses of registry data performed via distributed networks may prove a worthwhile infrastructure investment for pharmacovigilance.

  11. [The role of drug registries in the post-marketing surveillance].

    Science.gov (United States)

    Traversa, Giuseppe; Sagliocca, Luciano; Magrini, Nicola; Venegoni, Mauro

    2013-06-01

    The aim of this article is to provide an introduction to issue of Recenti Progressi in Medicina, devoted to the role of drug registries in the post-marketing surveillance. We first motivate the need to implement registries as a tool in promoting the appropriateness of drug use and acquiring additional information on the risk-benefit profile of drugs. Then, the different role that can be played by registries in comparison with prescription monitoring systems and observational studies is clarified. The presentation of some of the most relevant registries established in Italy since the end of the '90s, with the analysis of their strengths and weaknesses, helps to understand some of the crucial issues that should be taken into account before a new registry is adopted. Specifically, we deal with the relationship between objectives - of appropriateness, effectiveness and safety - and methods; the overlapping between drug-based registries and disease-based ones; the duration and extension of data collection, which may be either exhaustive or based on a sampling frame; the importance of ensuring the quality of the data and to minimize the number of subjects who are lost to follow-up; the importance of infrastructures, and of ad hoc funding, for the functioning of a registry; the independence in data analysis and publication of findings.

  12. Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction

    Directory of Open Access Journals (Sweden)

    Nawroth F

    2015-04-01

    Full Text Available Frank Nawroth,1 Andreas Tandler-Schneider,2 Wilma Bilger3 1Centre for Reproductive and Prenatal Medicine, Endocrinology and Osteology, Hamburg, Germany; 2Center for Reproductive Medicine, Fertility Center Berlin, Berlin, Germany; 3Medical Affairs, Fertility, Endocrinology and General Medicine, Merck Serono GmbH, Darmstadt, Germany (an affiliate of Merck KGaA, Darmstadt, Germany Abstract: This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles 15 mm. Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population. The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%, 50.0 IU (n=1,056 from N=3,189; 33.1%, and 75.0 IU (n=738 from N=3,189; 23.1% on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%, 50.0 IU (n=922 from N=3,189; 28.9%, and 75.0 IU (n=895 from N=3,189; 28.1% on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI. Keywords: ovulation

  13. Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance.

    Directory of Open Access Journals (Sweden)

    Joseph R Egger

    Full Text Available BACKGROUND: Postmarketing surveillance is routinely conducted to monitor performance of pharmaceuticals and testing devices in the marketplace. However, these surveillance methods are often done retrospectively and, as a result, are not designed to detect issues with performance in real-time. METHODS AND FINDINGS: Using HIV antibody screening test data from New York City STD clinics, we developed a formal, statistical method of prospectively detecting temporal clusters of poor performance of a screening test. From 2005 to 2008, New York City, as well as other states, observed unexpectedly high false-positive (FP rates in an oral fluid-based rapid test used for screening HIV. We attempted to formally assess whether the performance of this HIV screening test statistically deviated from both local expectation and the manufacturer's claim for the test. Results indicate that there were two significant temporal clusters in the FP rate of the oral HIV test, both of which exceeded the manufacturer's upper limit of the 95% CI for the product. Furthermore, the FP rate of the test varied significantly by both STD clinic and test lot, though not by test operator. CONCLUSIONS: Continuous monitoring of surveillance data has the benefit of providing information regarding test performance, and if conducted in real-time, it can enable programs to examine reasons for poor test performance in close proximity to the occurrence. Techniques used in this study could be a valuable addition for postmarketing surveillance of test performance and may become particularly important with the increase in rapid testing methods.

  14. The clinical efficacy of a clarithromycin-based regimen for Mycobacterium avium complex disease: A nationwide post-marketing study.

    Science.gov (United States)

    Kadota, Jun-Ichi; Kurashima, Atsuyuki; Suzuki, Katsuhiro

    2017-05-01

    The revised 2007 American Thoracic Society/Infectious Diseases Society of America statement recommend clarithromycin-based combination therapy for treatment of Mycobacterium avium complex lung disease and stipulates approximately 1 year of continuous treatment after bacilli negative conversion. However, supporting data are insufficient. Our objective was to obtain data on the clinical outcome of clarithromycin-based daily regimens by conducting a nationwide retrospective post-marketing study of M. avium complex lung disease. In accordance with the Japanese guidelines, patients were enrolled in this survey according to their chest radiographic findings and microbiologic test results. They were treated with a multidrug regimen including clarithromycin, rifampicin, and ethambutol (clarithromycin-based regimen) until bacilli negative conversion, and the treatment was continued for approximately 1 year after the initial conversion. Data were collected before administration, at the time of bacilli negative conversion, at the end of treatment, and at 6 months after the end of treatment. Of the 466 subjects enrolled in the study, 271 patients who received clarithromycin at 800 mg/day underwent evaluation for M. avium complex disease. The final bacilli negative conversion rate in those patients was 94.7%. The bacteriological relapse rate was 5.0% (5/100 patients). Bacteriological relapse was noted in patients treated for less than 15 months after conversion. No life-threatening or serious adverse drug reactions were observed. This study demonstrated that a clarithromycin-based daily regimen can yield a high bacteriological conversion rate in M. avium complex disease. After conversion, treatment for less than 15 months might be insufficient to prevent bacteriological relapse. Copyright © 2017 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  15. Decision support methods for the detection of adverse events in post-marketing data.

    Science.gov (United States)

    Hauben, M; Bate, A

    2009-04-01

    Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical measures of reporting frequency for huge numbers of drug-event combinations are increasingly used to support pharamcovigilance analysts screening large spontaneous reporting system databases. After an overview of pharmacovigilance and spontaneous reporting systems, we discuss the theory and application of contemporary computer algorithms in regular use, those under development, and the practical considerations involved in the implementation of computer algorithms within a comprehensive and holistic drug safety signal detection program.

  16. Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

    Science.gov (United States)

    Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

    2017-11-01

    Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

  17. Prodromal signs and symptoms of serious infections with tocilizumab treatment for rheumatoid arthritis: Text mining of the Japanese postmarketing adverse event-reporting database.

    Science.gov (United States)

    Atsumi, Tatsuya; Ando, Yoshiaki; Matsuda, Shinichi; Tomizawa, Shiho; Tanaka, Riwa; Takagi, Nobuhiro; Nakasone, Ayako

    2018-05-01

    To search for signs and symptoms before serious infection (SI) occurs in tocilizumab (TCZ)-treated rheumatoid arthritis (RA) patients. Individual case safety reports, including structured (age, sex, adverse event [AE]) and unstructured (clinical narratives) data, were analyzed by automated text mining from a Japanese post-marketing AE-reporting database (16 April 2008-10 April 2015) assuming the following: treated in Japan; TCZ RA treatment; ≥1 SI; unable to exclude causality between TCZ and SIs. The database included 7653 RA patients; 1221 reports met four criteria, encompassing 1591 SIs. Frequent SIs were pneumonia (15.9%), cellulitis (9.9%), and sepsis (5.0%). Reports for 782 patients included SI onset date; 60.7% of patients had signs/symptoms ≤28 days before SI diagnosis, 32.7% had signs/symptoms with date unidentified, 1.7% were asymptomatic, and 4.9% had unknown signs/symptoms. The most frequent signs/symptoms were for skin (swelling and pain) and respiratory (cough and pyrexia) infections. Among 68 patients who had normal laboratory results for C-reactive protein, body temperature, and white blood cell count, 94.1% had signs or symptoms of infection. This study identified prodromal signs and symptoms of SIs in RA patients receiving TCZ. Data mining clinical narratives from post-marketing AE databases may be beneficial in characterizing SIs.

  18. The Importance of Registries in the Postmarketing Surveillance of Surgical Meshes.

    Science.gov (United States)

    Köckerling, Ferdinand; Simon, Thomas; Hukauf, Martin; Hellinger, Achim; Fortelny, Rene; Reinpold, Wolfgang; Bittner, Reinhard

    2017-06-07

    To assess the role of registries in the postmarketing surveillance of surgical meshes. To date, surgical meshes are classified as group II medical devices. Class II devices do not require premarket clearance by clinical studies. Ethicon initiated a voluntary market withdrawal of Physiomesh for laparoscopic use after an analysis of unpublished data from the 2 large independent hernia registries-Herniamed German Registry and Danish Hernia Database. This paper now presents the relevant data from the Herniamed Registry. The present analysis compares the prospective perioperative and 1-year follow-up data collected for all patients with incisional hernia who had undergone elective laparoscopic intraperitoneal onlay mesh repair either with Physiomesh (n = 1380) or with other meshes recommended in the guidelines (n = 3834). Patients with Physiomesh repair had a markedly higher recurrence rate compared with the other recommended meshes (12.0% vs 5.0%; P manufacturing company must be taken into account.This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.

  19. ["Re-evaluation upon suspected event" is an approach for post-marketing clinical study: lessons from adverse drug events related to Bupleuri Radix preparations].

    Science.gov (United States)

    Wu, Shu-Xin; Sun, Hong-Feng; Yang, Xiao-Hui; Long, Hong-Zhu; Ye, Zu-Guang; Ji, Shao-Liang; Zhang, Li

    2014-08-01

    We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in

  20. Clinical outcomes with daptomycin: a post-marketing, real-world evaluation.

    Science.gov (United States)

    Sakoulas, G

    2009-12-01

    The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.

  1. Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study – PRIME study

    Directory of Open Access Journals (Sweden)

    Shah K

    2017-05-01

    Full Text Available Kshitij Shah,1 Omvijay B Chaudhari,2 Palash Gupta,3 R Hom Chaudhuri,4 Ranjan Kamilya,5 Shreedhar S Kulkarni,6 S Subbaiah,7 Zubair H Sorathia,8 Gauri Billa9 1MS Orthopedic, Prime Hospital, Andheri (West, 2Vatsalya Nursing Home, Kalyan (West, Mumbai, 3Dr. Palash Gupta Clinic, Rohini, New Delhi, 4Homchaudhuri’s Clinic, 5Apollo Gleneagles Hospital, Kolkata, West Bengal, 6Amrit Clinic, Matunga, Mumbai, 7Subbaiah’s Clinic, West Mambalam, Chennai, 8Medicare Hospital, Marol, Andheri East, 9Medical Services, Abbott Healthcare Pvt. Ltd, Mulund (West, Mumbai, Maharashtra, India Objective: To assess the effectiveness, overall tolerability, and gastrointestinal (GI tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg] in symptomatic treatment of severe acute pain in physician’s routine clinical practice. Materials and methods: In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18–60 years with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at baseline, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. Results: A total of 351 patients (mean age 44.2 years; male 43%; female 57% were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (p<0.0001. The number of patients with severe intensity of pain reduced from 100% at baseline to 18.3% at day 2 and 6.96% at day 5. According to the patient assessment, 68.36% of patients reported tolerability as “very good to good”, whereas according to physician’s assessment, “very good to good” tolerability was reported in 68.27% of patients. Five (1.43 % patients discontinued the study because of adverse drug reaction. Five patients developed nine GI-related events of moderate intensity. Two patients

  2. Safety and effectiveness of gemcitabine in 260 patients with biliary tract cancer in a Japanese clinical practice based on post-marketing surveillance in Japan.

    Science.gov (United States)

    Okubo, Sumiko; Nishiuma, Shinichi; Kobayashi, Noriko; Taketsuna, Masanori; Taniai, Hisashi

    2012-11-01

    Gemcitabine was approved for the treatment of biliary tract cancer in 2006 in Japan. While biliary tract cancer is usually associated with patients 70 years of age or older and/or those who tend to have underlying liver dysfunction, data on this population were limited in the Japanese Phase II study of gemcitabine. Thus, further evaluation of safety and effectiveness in this population was planned. This special post-marketing surveillance was conducted as an observational study on the use of gemcitabine in a clinical practice setting. Gemcitabine-naïve patients with biliary tract cancer were enrolled from 2006 to 2008 and observed over 12 months; one or more doses of gemcitabine were administered during the period. Data such as patient background, treatment details, adverse events occurring during the observational period, laboratory values of liver enzyme and survival status were collected 3 and 12 months after the start of therapy. Of the 285 patients registered for the study, 260 were included in the analysis. The mean age was 66.9 years. There were 120 patients (46.2%) classified as elderly (70 years or older). Haematotoxicities were the most common adverse drug reactions. In the elderly and the non-elderly, adverse drug reactions (serious) occurred in 48.3% (20.8%) and 50.7% (12.9%), respectively. The overall estimated 1-year survival rate was 52.5% (95% confidence interval, 45.9-58.7%). In line with previous clinical and post-marketing studies conducted in Japan, the results of this study suggest that gemcitabine could be used safely and effectively for biliary tract cancer patients including the elderly.

  3. Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results.

    Science.gov (United States)

    Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Snyder, Scott A; Dake, Michael D

    2016-02-08

    This multicenter, prospective, post-market surveillance study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized study and a complementary, large single-arm study supported the safety and effectiveness of the DES. There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. In this study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. Despite more challenging lesions, results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  4. Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence.

    Science.gov (United States)

    Kuwayama, Yasuaki; Hashimoto, Masako; Kakegawa, Reiko; Nomura, Akio; Shimada, Fumiki

    2017-06-01

    The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance. This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected. Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years. Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with

  5. Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study.

    Science.gov (United States)

    Yahno, Nikolay N; Fedotova, Anastasia V

    2017-01-01

    In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197), fluvoxamine (50-300 mg/day for 90 days) was effective for the treatment of depression in 299 adult patients (age ≥18 years) with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively), global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale). The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296) was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant ( P 85%) recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200) experienced moderate to very substantial clinical improvement, with no or limited side effects. Significant improvements were also recorded in the exploratory outcomes of sleep quality, assessed using the Insomnia Severity Index, and cognitive function, assessed using the Montreal Cognitive Assessment ( P effective and well tolerated for the treatment of depression in the context of neurological disorders. The effects on the exploratory endpoints of this research merit evaluation in controlled trials.

  6. Post-marketing surveillance of OraQuick whole blood and oral fluid rapid HIV testing.

    Science.gov (United States)

    Wesolowski, Laura G; MacKellar, Duncan A; Facente, Shelley N; Dowling, Teri; Ethridge, Steven F; Zhu, Julia H; Sullivan, Patrick S

    2006-08-01

    Post-marketing surveillance was conducted to monitor the performance of the OraQuick Advance rapid HIV-1/2 antibody test (OraQuick) on whole blood and oral fluid. Surveillance of routinely collected data on clients tested with OraQuick in 368 testing sites affiliated with 17 state and city health departments between 11 August 2004 and 30 June 2005. For whole blood and oral fluid, we report the median (range) health department OraQuick specificity and positive predictive value (PPV), and the number of clients with discordant results (e.g. who had a reactive rapid test not confirmed positive by Western blot or indirect immunofluorescence). At one site with lower than expected oral-fluid specificity, we evaluated whether device expiration, manufacturing lot, operator practices, or device-storage or testing-area temperatures were associated with false-positive tests. During the surveillance period, 135 724 whole blood and 26 066 oral fluid rapid tests were conducted. The median health department whole blood OraQuick specificity was 99.98% (range: 99.73-100%) and PPV was 99.24% (range: 66.67-100%); the median oral fluid specificity was 99.89% (range: 99.44-100%) and PPV was 90.00% (range: 50.00-100%). A total of 124 discordant results were reported from 68 (0.05%) whole blood and 56 (0.22%) oral fluid rapid tests. The oral fluid specificity at the site with excess oral fluid false-positive tests was 98.7% (95% confidence interval: 98.18-99.11%). The increase in false-positive tests at that site was not associated with any specific device characteristic, operator procedure or temperature condition. The specificity of OraQuick performed on whole blood and oral fluid during post-marketing surveillance was compatible with the manufacturer's claim within the package insert. However, one site experienced lower than expected oral fluid specificity. Sites that observe that the specificity of OraQuick is lower than the range indicated in the package insert should notify the

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

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

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

  8. The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese male patients with osteoporosis.

    Science.gov (United States)

    Kondo, Satoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Furuno, Yuko; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

    2018-03-12

    We conducted a post-marketing observational study to investigate the safety and effectiveness of eldecalcitol for the treatment of osteoporosis in a Japanese clinical setting. The observation period was 12 months for women and 36 months for men. The final results for the female patients have already been published. In this article, the final results for the male patients are reported. A total of 470 male osteoporosis patients were enrolled. The safety analysis set included 431 patients (mean age, 76.8 years; mean ± SD follow-up period, 631.0 ± 450.3 days), and 175 patients continued treatment throughout the 3-year observational period. Adverse drug reactions (ADRs) were reported in 28 patients (6.49%); the most common ADRs were hypercalcemia (1.16%) and renal impairment (1.16%). Serious ADRs were reported in 5 patients (1.16%). Mean serum calcium was within the normal range throughout the observation period. The cumulative incidence of new vertebral and nonvertebral fractures at 36 months, estimated by Kaplan-Meier analysis, was 10.23 and 4.06%, respectively. At the last observation, mean lumbar spine bone mineral density was 3.49% higher (P effectiveness of eldecalcitol for the treatment of Japanese male osteoporosis patients was confirmed in clinical practice. Careful monitoring of serum calcium and estimated glomerular filtration rate, both before and during treatment, is necessary to minimize the risk of hypercalcemia and renal impairment while maximizing the effectiveness of eldecalcitol.

  9. Evaluation of the Relative Abuse of an OROS® Extended-release Hydromorphone HCI Product: Results from three Post-market Surveillance Studies.

    Science.gov (United States)

    Butler, Stephen F; McNaughton, Emily C; Black, Ryan A; Cassidy, Theresa A

    2018-01-02

    Formulating prescription opioids to limit abuse remains a priority. OROS® extended-release (ER) hydromorphone HCl (EXALGO®) may have low abuse potential. Three post-marketing studies of the relative abuse liability of OROS hydromorphone ER were conducted. Estimates of abuse, unadjusted and adjusted for prescription volume, were generated for OROS hydromorphone ER and comparators from Q2 2010 through Q2 2014 for a high-risk, substance abuse treatment population and the general population using poison control center data. Comparators were selected for compound, market penetration, and route of administration (ROA) profile. ROA comparisons were made among the substance abuse treatment population. Internet discussion was examined to determine abusers' interest in and desire for the OROS formulation. Examination of abuse prevalence among adults within substance abuse treatment, intentional poison exposures and Internet discussion levels generally support the hypothesis that OROS hydromorphone ER may have lower abuse potential than many other opioid products. OROS hydromorphone ER also appears to be abused less often by alternate ROAs (e.g., snorting and injection). Lower levels of online discussion were observed along with relatively low endorsement for abuse. Abuse of OROS hydromorphone ER was observed in high-risk substance abuse and general population samples but at a very low relative prevalence. Evidence suggests it may be less often abused by alternate ROAs than some comparators. Online data did not find evidence of high levels of desire for OROS hydromorphone ER by recreational abusers. Continued monitoring of this product's abuse liability is warranted.

  10. A Post-marketing Surveillance Study of Chronic Wounds Treated With a Native Collagen Calcium Alginate Dressing.

    Science.gov (United States)

    Sabo, Matthew; Le, Lam; Yaakov, Raphael A; Carter, Marissa; Serena, Thomas E

    2018-04-01

    Chronic wounds (ie, wounds that fail to progress through a normal, orderly, timely sequence of repair) continue to pose significant clinical and economic burdens. A prospective, descriptive, 3-week post-marketing surveillance study was conducted across 3 wound care centers in the United States to evaluate the effectiveness of a collagen calcium alginate dressing on chronic wounds in conjunction with standard care (SC) practices (eg, offloading, debridement, compression) to support healing. Eligible participants had to be >18 years of age, have at least 1 chronic wound, and no known sensitivity to collagen. Demographic characteristics were recorded at the screening visit on case report forms. At each visit, wound-related pain was assessed using the Visual Analog Scale along with wound characteristics including size (using digital planimetry), wound exudate (minimal, moderate, heavy), and odor (none, mild). Participants were monitored for adverse events as well as infection based on signs and symptoms in and around the local wound bed, the deeper structures, and the surrounding skin. An intention-to-treat approach was used for all analyses. If an observation was missing, the last observation carried forward principle was used. For wounds that healed, pain and exudate were set to 0 (no pain/exudate) at visit 4. Descriptive, paired t tests and the Wilcoxon signed rank test were used to analyze the data. Of the 31 participants (15 men, 16 women, mean age 66.6 years), most (13, 42%) had a diabetic foot ulcer or venous leg ulcer (10, 32%); median duration of all wounds was 148 days. Thirty (30) patients completed the study. The mean number of comorbidities was 10.6 ± 6.3, and patients used a mean of 9.3 ± 5.64 prescription or over-the-counter medications. For all wounds combined, mean wound area was 4.8 ± 8.38 cm2 at baseline. At week 3, a decrease in wound area of 38.1% was noted (median: 45% ± 42.54; P = .006); 3 wounds healed completely. The change in wound exudate

  11. Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations

    Directory of Open Access Journals (Sweden)

    Wang C

    2018-04-01

    Full Text Available Can Wang,1,2 Qing-ping Shi,1,2 Feng Ding,2 Xiao-dong Jiang,1,2 Wei Tang,3 Mei-Ling Yu,1,2 Jian-Hua Zhu2 1Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People’s Republic of China; 2Faculty of Pharmacy, Bengbu Medical College, Bengbu, People’s Republic of China; 3Department of Pharmacy, Huaiyuan County Hospital of TCM in Anhui, Bengbu, People’s Republic of China Aim: To evaluate the factors influencing suspected hypersensitivity and adverse systemic reactions after Shuxuening injection and to provide innovative ideas and methods for the reevaluation of post-marketing safety of Shuxuening.Methods: This study used a prospective, nested case–control study design, combined with a prescription sequence analysis design method. It classified patients who exhibited trigger signals after administration of Shuxuening injection as suspected allergic patients and made comparisons with patients who did not report adverse effects to calculate the correlation between relevant risk factors and suspected allergic reactions. Randomized controlled studies and cohort studies of the adverse drug reaction (ADR of Shuxuening were performed using a computer database. Data retrieval was carried out by the foundation governing the individual database. Meta-analysis was performed by using R3.2.3 software to evaluate the ADRs of Shuxuening.Results: The results of real-world study showed that administration of Shuxuening in combination with potassium aspartate and magnesium, atorvastatin calcium, Shengmai injection, pantoprazole sodium, or high-dose medication was a risk factor for suspected allergic reactions. Meta-analysis showed that the incidence of adverse events was 5.84% (95% CI 0.0499; 0.0674, and serious adverse reaction rate was 4.36% (95% CI 0.0188; 0.0760 when Shuxuening was used in combination with these drugs. The incidence of allergic reaction was also influenced by the vehicle, duration of treatment, single

  12. A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER Database and Association Analysis.

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    Masakazu Fujiwara

    Full Text Available Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender has not been proposed.We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA. We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male.Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported adverse drug reactions

  13. Dabigatran Levels in Elderly Patients with Atrial Fibrillation: First Post-Marketing Experiences.

    Science.gov (United States)

    Bolek, Tomáš; Samoš, Matej; Škorňová, Ingrid; Stančiaková, Lucia; Staško, Ján; Galajda, Peter; Kubisz, Peter; Mokáň, Marián

    2018-05-08

    The number of elderly individuals with non-valvular atrial fibrillation (NV-AF) requiring long-term anticoagulation is rising. The pharmacokinetics of oral anticoagulants in elderly individuals may differ from that for younger patients. The aim of this study was to assess the dabigatran levels in elderly patients with NV-AF. A pilot prospective post-marketing study in patients with NV-AF on dabigatran therapy was performed; we enrolled 21 consecutive elderly patients (aged ≥ 75 years) on a reduced dabigatran regimen (110 mg twice daily) and compared them with 13 younger (≤ 70 years) individuals on reduced dabigatran therapy due to renal impairment and with 16 younger patients on standard dabigatran therapy (150 mg twice daily). Blood samples were taken for the assessment of dabigatran trough and peak levels. Dabigatran levels were measured with the Hemoclot ® Thrombin Inhibitor Assay. There were significant differences in dabigatran trough levels when comparing elderly patients on reduced dabigatran with non-elderly patients on reduced dabigatran (99.3 ± 73.6 vs 51.6 ± 25.6 ng/mL; p Similarly, the detected dabigatran peak levels were significantly higher in elderly patients on reduced dabigatran compared with non-elderly patients on reduced dabigatran (173.4 ± 116.2 vs 116.1 ± 19.1 ng/mL; p similar levels compared with younger individuals on standard dabigatran.

  14. The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study.

    Science.gov (United States)

    Gory, Benjamin; Blanc, Raphaël; Turjman, Francis; Berge, Jérôme; Piotin, Michel

    2018-02-02

    The Barrel vascular reconstruction device (Barrel VRD) is a novel stent with design features that allow endovascular coiling of wide-necked bifurcation aneurysms while preserving adjacent branches, without necessitating dual stent implantation. This study aimed to assess the safety and effectiveness of the Barrel VRD at 12-month follow-up. The Barrel VRD trial is a prospective, multicenter, observational post-marketing registry evaluating the use of the Barrel VRD for treatment of wide-necked bifurcation aneurysms. The primary effectiveness endpoint was successful aneurysm treatment measured by digital subtraction angiography with a Raymond-Roy occlusion grade of 1 or 2 in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture at 12 months. The primary safety endpoint was the absence of neurological death or major stroke at 12 months. Twenty patients were enrolled from December 2013 to December 2014. The device was implanted in 19 patients with 19 aneurysms (8 middle cerebral artery, 4 anterior communicating artery, 1 internal carotid artery terminus, 4 basilar artery aneurysms; mean dome height 5.7±1.91 mm; mean neck length 4.8±1.35 mm, mean dome-to-neck ratio 1.6±2.0). Coiling was performed in all cases. The primary effectiveness endpoint was achieved in 78.9% of subjects (15/19; 12 complete occlusions, 3 neck remnants), and the primary safety endpoint was 5.3% (1/19). This prospective study demonstrates that the Barrel VRD device resulted in ~80% occlusion rates and ~5% rates of neurological complications at 1 year after endovascular treatment of wide-necked bifurcation intracranial aneurysms. REGISTERED CLINICAL TRIAL: NCT02125097;Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective, International, Post-Market ADVANCE-II Study.

    Science.gov (United States)

    Petronio, Anna S; Sinning, Jan-Malte; Van Mieghem, Nicolas; Zucchelli, Giulio; Nickenig, Georg; Bekeredjian, Raffi; Bosmans, Johan; Bedogni, Francesco; Branny, Marian; Stangl, Karl; Kovac, Jan; Schiltgen, Molly; Kraus, Stacia; de Jaegere, Peter

    2015-05-01

    The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing. Conduction disturbances are a frequent complication of transcatheter aortic valve replacement. The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI. The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth (≤6 mm below the aortic annulus). The timing and resolution of all new-onset conduction disturbances were analyzed. A total of 194 patients were treated. The overall rate of PPI for Class I/II indications was 18.2%. An optimal depth was reached in 43.2% of patients, with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm, compared with those with deeper implants (13.3% vs. 21.1%; p = 0.14). In a paired analysis, new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4% and 39.0% of patients, respectively, and resolved spontaneously within 30 days in 43.2% and 73.9%, respectively. In patients with new PPI, the rate of intrinsic sinus rhythm increased from 25.9% at 7 days to 59.3% at 30 days (p = 0.004). Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement, compared with results reported in previous studies. (CoreValve Advance-II Study: Prospective International Post-Market Study [ADVANCE II]; NCT01624870). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  16. Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data.

    Science.gov (United States)

    Ma, Handong; Weng, Chunhua

    2016-04-01

    To link public data resources for predicting post-marketing drug safety label changes by analyzing the Convergent Focus Shift patterns among drug testing trials. We identified 256 top-selling prescription drugs between 2003 and 2013 and divided them into 83 BBW drugs (drugs with at least one black box warning label) and 173 ROBUST drugs (drugs without any black box warning label) based on their FDA black box warning (BBW) records. We retrieved 7499 clinical trials that each had at least one of these drugs for intervention from the ClinicalTrials.gov. We stratified all the trials by pre-marketing or post-marketing status, study phase, and study start date. For each trial, we retrieved drug and disease concepts from clinical trial summaries to model its study population using medParser and SNOMED-CT. Convergent Focus Shift (CFS) pattern was calculated and used to assess the temporal changes in study populations from pre-marketing to post-marketing trials for each drug. Then we selected 68 candidate drugs, 18 with BBW warning and 50 without, that each had at least nine pre-marketing trials and nine post-marketing trials for predictive modeling. A random forest predictive model was developed to predict BBW acquisition incidents based on CFS patterns among these drugs. Pre- and post-marketing trials of BBW and ROBUST drugs were compared to look for their differences in CFS patterns. Among the 18 BBW drugs, we consistently observed that the post-marketing trials focused more on recruiting patients with medical conditions previously unconsidered in the pre-marketing trials. In contrast, among the 50 ROBUST drugs, the post-marketing trials involved a variety of medications for testing their associations with target intervention(s). We found it feasible to predict BBW acquisitions using different CFS patterns between the two groups of drugs. Our random forest predictor achieved an AUC of 0.77. We also demonstrated the feasibility of the predictor for identifying long

  17. Hazardous and Industrial Wastes Management: a Case Study of Khazra Industrial Park, Kerman

    Directory of Open Access Journals (Sweden)

    Hossein Jafari Mansoorian

    2013-08-01

    Full Text Available Background & Aims of the Study: Increasing hazardous industrial wastes and lack of necessary regulations for management of them have led to serious problems in some parts of Iran. The aim of this study was to evaluate the situation of collection, transportation, recycling, and disposal of hazardous industrial wastes in the Khazra Industrial Park of Kerman, Iran. Materials & Methods: This study was a descriptive cross-sectional study that was done using questionnaires and local visits during year 2009. In this questionnaire, some information about the industrial wastes, production, storage on site , collection, transformation, sorting, recycling, and disposal were recorded. Results:   In the Khazra Industrial Park, 71,600 kg/day of different industrial waste is produced. The biggest proportion of waste includes metals, and construction and demolition waste which are about 16,500 tons a year. The smallest proportion is non-iron metal waste, which is produced at a rate of 8 tons per year. 88.7 percent of the active industries at the Khazra Industrial Park produce solid industrial waste. Most of the industrial units do not use a united and coordinated system for storing waste and have no specific place for temporary storage inside the industrial park. The majority of industrial waste collection, which is about 59.8%, is done by private contractors. The industrial units transfer their waste separately, and just 9 industrial units recycle their waste. Disposal of these wastes is mainly done by selling to trading agencies. Each day, 3 tons of hazardous industrial waste is produced in this park. The highest production belongs to the oil factory (Keyhan Motor. Conclusions: According to the results, the Khazra Industrial Park needs a unified system for storing, transporting and collecting the sorted waste, and it also needs to have a transportation station with basic facilities. The wastes of most industrial units at the Khazra Industrial Park have the

  18. Physics in Industry: A Case Study

    Science.gov (United States)

    Pratt-Ferguson, Ben

    2007-10-01

    Often ignored and sometimes even considered ``black sheep'' by the university & government-lab physicists, many industrial physicists continue making valuable scientific contributions in diverse areas, from computer science to aero and thermo-dynamics, communications, mathematics, engineering, and simulation, to name a few. This talk will focus on what industrial physicists do, what preparations are beneficial to obtaining a first industrial job, and what the business environment is like for physicists. The case study will be that of the author, starting with undergraduate and graduate studies and continuing on to jobs in industry.

  19. 2001 Industry Studies: Education

    Science.gov (United States)

    2001-01-01

    schools sector is the image that comes to mind when most people think of education . It includ Page 3 of 22Industry Studies 2001 many childcare facilities ...negativism in public debate and the media concerning the U.S. education industry? Secretary of Education Rod Paige notes that even though statistics ...new skills requirements and a large influx of immigrants. The National Center for Education Statistics forecasts record level enrollments. Public

  20. Use of Carabids for the Post-Market Environmental Monitoring of Genetically Modified Crops

    Directory of Open Access Journals (Sweden)

    Oxana Skoková Habuštová

    2017-03-01

    Full Text Available Post-market environmental monitoring (PMEM of genetically modified (GM crops is required by EU legislation and has been a subject of debate for many years; however, no consensus on the methodology to be used has been reached. We explored the suitability of carabid beetles as surrogates for the detection of unintended effects of GM crops in general PMEM surveillance. Our study combines data on carabid communities from five maize field trials in Central Europe. Altogether, 86 species and 58,304 individuals were collected. Modeling based on the gradual elimination of the least abundant species, or of the fewest categories of functional traits, showed that a trait-based analysis of the most common species may be suitable for PMEM. Species represented by fewer than 230 individuals (all localities combined should be excluded and species with an abundance higher than 600 should be preserved for statistical analyses. Sixteen species, representing 15 categories of functional traits fulfill these criteria, are typical dominant inhabitants of agroecocoenoses in Central Europe, are easy to determine, and their functional classification is well known. The effect of sampling year is negligible when at least four samples are collected during maize development beginning from 1 April. The recommended methodology fulfills PMEM requirements, including applicability to large-scale use. However, suggested thresholds of carabid comparability should be verified before definitive conclusions are drawn.

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

    Science.gov (United States)

    Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

    2012-01-01

    Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.

  2. The POST trial: initial post-market experience of the Penumbra system: revascularization of large vessel occlusion in acute ischemic stroke in the United States and Europe.

    Science.gov (United States)

    Tarr, Robert; Hsu, Dan; Kulcsar, Zsolt; Bonvin, Christophe; Rufenacht, Daniel; Alfke, Karsten; Stingele, Robert; Jansen, Olav; Frei, Donald; Bellon, Richard; Madison, Michael; Struffert, Tobias; Dorfler, Arnd; Grunwald, Iris Q; Reith, Wolfgang; Haass, Anton

    2010-12-01

    The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application. A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial. A total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not. Initial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.

  3. Risk management and post-marketing surveillance of CNS drugs.

    Science.gov (United States)

    Henningfield, Jack E; Schuster, Charles R

    2009-12-01

    Drugs affecting the central nervous system span a broad range of chemical entities, dosage forms, indications, and risks. Unintended consequences include potential abuse and overdose in non-patient drug abusers, deliberate tampering of drug dosage forms, and criminal behavior associated with diversion. Regulators must consider diverse factors to find the appropriate conditions of approval to minimize unintended consequences while enabling a level of access desired by health care providers and patients. This commentary appears as part of a special issue of Drug and Alcohol Dependence that focuses on risk management and post-marketing surveillance and addresses key issues that pose real-world challenges to pharmaceutical sponsors and regulators in particular. For example, in the U.S., Controlled Substances Act drug scheduling can be considered a risk management strategy but its legal authorities and administrative processes are independent from those of risk management (including Risk Evaluation and Mitigation Strategies or REMS); better harmonization of these approaches is vital from drug development and regulatory perspectives. Risk management would ideally be implemented on a strong science foundation demonstrating that the tools employed to mitigate risks and ensure safe use are effective. In reality, research and evaluation of tools in this area is in its infancy and will necessarily be an evolutionary process; furthermore, there is little precedent for linking interventions and program evolution to unintended consequences such as regional outbreaks of abuse and diversion. How such issues are resolved has the potential to stimulate or stifle innovations in drug development and advance or imperil health care.

  4. Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study

    Directory of Open Access Journals (Sweden)

    Yahno NN

    2017-11-01

    Full Text Available Nikolay N Yahno,1 Anastasia V Fedotova2 1Neurology Department, I.M. Sechenov First Moscow State Medical University, 2Neurology Department, Additional Professional Education Faculty, Pirogov Russian National Research Medical University, Moscow, Russian Federation Abstract: In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197, fluvoxamine (50–300 mg/day for 90 days was effective for the treatment of depression in 299 adult patients (age ≥18 years with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively, global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale. The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296 was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant (P<0.0001 improvements in both scores were recorded during fluvoxamine treatment and later follow-up. Most patients (>85% recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200 experienced moderate to very substantial clinical improvement, with no or limited side effects. Significant improvements were also recorded in the exploratory outcomes of sleep quality, assessed using the Insomnia Severity Index, and cognitive function, assessed using the Montreal Cognitive Assessment (P<0.0001 vs baseline for both. No death or serious adverse drug reactions were reported during the study. The results of this observational study affirm that fluvoxamine is effective and well tolerated for the treatment of depression in the context of neurological disorders. The effects on the exploratory endpoints of this research merit evaluation in controlled trials. Keywords: depression, anxiety, fluvoxamine

  5. Safety and efficacy of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice: interim results of the STELLA-LONG TERM post-marketing surveillance study.

    Science.gov (United States)

    Nakamura, Ichiro; Maegawa, Hiroshi; Tobe, Kazuyuki; Tabuchi, Hiromi; Uno, Satoshi

    2018-02-01

    Data regarding the efficacy and safety of sodium-glucose cotransporter 2 inhibitors in the real-world setting in Japan are limited. The STELLA-LONG TERM study is an ongoing 3-year post-marketing surveillance study of ipragliflozin in type 2 diabetes (T2D) patients. Here, we report the interim results (including 3-, 12-, and 24-month data). All Japanese patients with T2D who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at participating centers in Japan were registered in STELLA-LONG TERM. At 3, 12, and 24 months, the safety analysis set comprised 11,053, 5475, and 138 patients, respectively; the efficacy analysis set comprised 8757 patients. Ipragliflozin treatment resulted in statistically significant improvements versus baseline in hemoglobin A1c, fasting plasma glucose concentration, body weight, blood pressure, heart rate, and serum concentrations of low-density lipoprotein cholesterol and triglycerides. The adverse drug reaction incidence rate was 10.71%, the most common reactions being renal and urinary disorders (5.06%), infections and infestations (1.24%), and skin and subcutaneous tissue disorders (1.14%). Ipragliflozin was well tolerated and effective in Japanese patients with T2D; no new safety issues were identified.

  6. Is patient-reported outcome improved by nalfurafine hydrochloride in patients with primary biliary cholangitis and refractory pruritus? A post-marketing, single-arm, prospective study.

    Science.gov (United States)

    Yagi, Minami; Tanaka, Atsushi; Namisaki, Tadashi; Takahashi, Atsushi; Abe, Masanori; Honda, Akira; Matsuzaki, Yasushi; Ohira, Hiromasa; Yoshiji, Hitoshi; Takikawa, Hajime

    2018-04-16

    Patients with primary biliary cholangitis (PBC) frequently suffer from pruritus, which can severely impair their health-related quality of life (HRQOL). Nalfurafine hydrochloride, a selective κ-opioid receptor agonist, was recently approved in Japan for refractory pruritus in patients with chronic liver diseases, but it still remains unclear whether this treatment improves the patient-reported outcome (PRO) in PBC patients with refractory pruritus. Herein, we conducted a multicenter, post-marketing, single-arm prospective study to investigate the efficacy of nalfurafine in terms of PRO, and the associations of the efficacy with any clinical characteristics. After screening for pruritus in 496 patients with PBC using PBC-40 and the visual analog scale (VAS), we identified 141 patients with moderate to severe pruritus; these were invited to participate in the study. The participants received 2.5 μg nalfurafine once daily for 12 weeks, and pruritus and HRQOL were assessed in week 12 of this treatment. Generic HRQOL, short form 36, blood chemistries, and serum autotaxin levels were also measured at baseline and at week 12. Forty-four patients participated in this study. The mean PBC-40 itch domain scores and VAS declined during the study period, from 8.56 to 7.63 (P = 0.041) and from 42.9 to 29.3 (P = 0.001) at baseline and at week 12, respectively, indicating a significant effect of nalfurafine. The other domains of PBC-40 and all domains of SF-36 were not significantly altered by this treatment. We failed to find any association between the change in VAS and PBC-40 itch scores and any clinical variable. Serum autotaxin levels were significantly increased during the study period. This study demonstrated that nalfurafine improved pruritus in patients with PBC, independent of their clinical characteristics, but had a limited effect on the PRO.

  7. Ulipristal acetate for emergency contraception: postmarketing experience after use by more than 1 million women.

    Science.gov (United States)

    Levy, Delphine P; Jager, Martine; Kapp, Nathalie; Abitbol, Jean-Louis

    2014-05-01

    To describe the safety of ulipristal acetate in emergency contraception. Postmarketing pharmacovigilance data collection. A total of 553 women experienced 1049 adverse drug reactions. The most frequent (n,%) were pregnancies (282, 6.8%); nausea, abdominal pain and vomiting (139, 13.3%); headache, dizziness (67, 6.4%); and metrorrhagia, menses delay and breast symptoms (84, 8.0%). Including data from clinical trials, 376 pregnancies have been reported in total, 232 (62%) with a known outcome: 28 live births (29 newborns), 34 miscarriages, 151 induced abortions, 4 ectopics and 15 which are ongoing. No safety concern emerges from a sizable database of reported adverse reactions following ulipristal acetate exposure among varying ethnicities and regions. Postapproval data confirm the safety profile described during the clinical trials. Use of ulipristal acetate for emergency contraception in a variety of settings and among diverse populations indicate that it is safe and without unexpected or serious adverse events. Copyright © 2014 Elsevier Inc. All rights reserved.

  8. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study.

    Science.gov (United States)

    Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

    2015-01-01

    The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period. The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1-4) in the tibio-femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection. An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated. The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated. Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce their required doses, and delay potential future surgical intervention.

  9. A multicenter post-marketing evaluation of the Elixir DESolve® Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study.

    Science.gov (United States)

    Nef, Holger; Wiebe, Jens; Boeder, Niklas; Dörr, Oliver; Bauer, Timm; Hauptmann, Karl-Eugen; Latib, Azeem; Colombo, Antonio; Fischer, Dieter; Rudolph, Tanja; Foin, Nicolas; Richardt, Gert; Hamm, Christian

    2018-03-06

    To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed. © 2018 Wiley Periodicals, Inc.

  10. Integrated health outcomes research strategies in drug or medical device development, pre- and postmarketing: time for change.

    Science.gov (United States)

    Badía, Xavier; Guyver, Alice; Magaz, Sol; Bigorra, Juan

    2002-06-01

    The implementation of health outcomes research as a healthcare decision-making tool has expanded rapidly in the last decade. Drugs and medical devices are increasingly being required to demonstrate not only their efficacy and safety characteristics, but also their performance in at least three core dimensions of health outcomes research: clinical effectiveness, patient-reported outcomes and economic outcomes. However, the current integration of health outcomes research lacks coordination and communication and as a result, money and time is being spent on the generation of health outcomes research data which can be both insufficient and fail to satisfy the information demands of all the relevant stakeholders. In response to this, a new paradigm is evolving which involves the implementation of health outcomes research strategies that encompass the development, pre- and postmarketing stages of a drug or medical device.

  11. Which industry is greener? An empirical study of nine industries in OECD countries

    International Nuclear Information System (INIS)

    Fujii, Hidemichi; Managi, Shunsuke

    2013-01-01

    This study analyzed the relationship between the CO 2 emissions of different industries and economic growth in OECD countries from 1970 to 2005. We tested an environmental Kuznets curve (EKC) hypothesis and found that total CO 2 emissions from nine industries show an N-shaped trend instead of an inverted U or monotonic increasing trend with increasing income. The EKC hypothesis for sector-level CO 2 emissions was supported in the (1) paper, pulp, and printing industry; (2) wood and wood products industry; and (3) construction industry. We also found that emissions from coal and oil increase with economic growth in the steel and construction industries. In addition, the non-metallic minerals, machinery, and transport equipment industries tend to have increased emissions from oil and electricity with economic growth. Finally, the EKC turning point and the relationship between GDP per capita and sectoral CO 2 emissions differ among industries according to the fuel type used. Therefore, environmental policies for CO 2 reduction must consider these differences in industrial characteristics. - Highlights: ► We analyze the relationship between CO 2 emissions and economic growth by industry. ► Wood, paper, and construction industries have an inverted U-shaped relationship. ► The turning points differ among industries according to the fuel type used. ► The policies for CO 2 reduction must consider differences in industrial characteristics

  12. The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese patients with osteoporosis: interim report.

    Science.gov (United States)

    Saito, Hitoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Yatomi, Sawako; Nihojima, Shigeru; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

    2017-07-01

    This large-scale post-marketing surveillance study was conducted to assess the safety and effectiveness of eldecalcitol treatment in patients with osteoporosis in a Japanese clinical setting. A total of 3567 patients with osteoporosis were enrolled and received eldecalcitol 0.75 μg/day for 12 months. For this interim report, 3285 patients were eligible for analysis. Mean age was 74.9 ± 8.7 years; 86.8 % (2854/3285) were women. There were 142 reported adverse drug reactions (ADRs) in 129 patients (3.92 % of the total 3285 patients): the most common were hypercalcemia and increased blood calcium (0.88 %), renal impairment (0.27 %), abdominal discomfort (0.24 %), constipation (0.24 %), and pruritus (0.24 %). The incidence of ADRs was 5.10 % in men and 3.74 % in women. Although 10 serious ADRs were reported in 9 patients (0.27 %), no clinically significant safety issues were identified. Incidence of hypercalcemia or increased blood calcium was 8.47 % in patients with renal impairment and only 0.74 % in patients without renal impairment. At last observation, the incidence of new vertebral and nonvertebral fractures was 2.44 % and 1.70 %, respectively. There was a significant increase in bone mineral density at the lumbar spine and distal radius. The bone turnover markers BAP, serum NTX, urinary NTX, and TRACP-5b were suppressed by eldecalcitol treatment in both sexes. In conclusion, consistent with the findings of the phase III pivotal clinical trial, eldecalcitol was shown to have a favorable safety profile and effectiveness in Japanese patients with osteoporosis. However, periodic measurements of serum calcium were required to prevent occurrence of hypercalcemia during eldecalcitol treatment, especially in patients with renal impairment.

  13. 2001 Industry Studies: Services Industry

    National Research Council Canada - National Science Library

    Cervone, Michael

    2001-01-01

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

  14. Studying the features of industrial tourism development and ...

    African Journals Online (AJOL)

    Study methods: The key method of studying this issue is a content analysis of the websites of organizations involved in the system of industrial tourism ... districts, and information on the excursions to industrial enterprises in the media; the survey results of industrial enterprises and consumers of tourism facilities are provided ...

  15. Nuclear Industry Family Study

    International Nuclear Information System (INIS)

    1993-01-01

    This is a copy of the U.K.A.E.A. Question and Answer brief concerning an epidemiological study entitled the Nuclear Industry Family Study, to investigate the health of children of AEA, AWE, and BNFL Workers. The study is being carried out by an independent team of medical research workers from the London School of Hygiene and Tropical Medicine, and the Imperial Cancer Research Fund. (UK)

  16. Ethos and industry: a critical study of oil industry advertising from 1974-1984

    Energy Technology Data Exchange (ETDEWEB)

    Kurzbard, G.

    1984-01-01

    This study examines the advocacy advertising of the oil industry in general, and Mobil and Exxon Corporations in particular, during the years 1974-1984. The prospects of divestiture and nationalization of the industry, as a result of both gasoline shortages and exponential increases in profits which begin in the early seventies', created a profound concern by the majors that increasing public disaffection might result in legislation inimical to the industry. Mobil and Exxon's advertising attempted to provide a justification not only for their own operations, but for the entire American socio-economic system. The industry's value system was clearly reflected in its efforts to convince the public that its motives grew from an abiding commitment to the nation's well-being. The ideational underpinnings of oil industry discourse are traced through a rhetorical exploration of specific advertising campaigns. The study maintains that the weltanschauung of Big Oil is both directly and indirectly manifest in its advertising. An overall assessment of oil industry advertising is provided within a Burkean framework to treat of the textural elements of its discourse.

  17. Industry Study, Environment Industry, Spring 2009

    Science.gov (United States)

    2009-01-01

    practices. For example, the cruising sector of the tourism industry has widely- acknowledged negative environmental impacts (carbon emissions and ocean...Services: An Industry Analysis ,” (2009): 4. http://www.berr.gov.uk/files/file50253.pdf 18 Ibid., 5. 19 EBI, 21 20 Department for Business...Ibid., 26. 50 DataMonitor Country Analysis Report, “Korea: In-Depth PESTLE Insights,” (June 2008): 4. 51 EBI, “3000,” 1-22. 52 Ibid., 5-130, 5

  18. Active solar heating industry development study

    International Nuclear Information System (INIS)

    1995-01-01

    Despite the fact that solar water heating systems are technologically viable and commercially available, this Energy Technology Support Unit report shows that there is no established market in the United Kingdom. The Solar Trade Association (STA) has undertaken an Active Solar Heating Industry Development Study which is reported here. The data is derived from a questionnaire survey completed by companies, organizations and individuals operating within the industry. Information was also gathered from utility companies, and STAs elsewhere in Europe. Barriers which need to be overcome include lack of public awareness, especially in the construction industry, lack of capital investment and other financial disincentives, little or no government support, and lack of organization and quality monitoring and assurance within the industry itself. (UK)

  19. Radioisotope tracers in industrial flow studies

    International Nuclear Information System (INIS)

    Easey, J.F.

    1987-01-01

    The scope of radioisotope tracer work carried out by ANSTO has involved most sectors of Australian industry including iron and steel coal, chemical, petrochemical, natural gas, metallurgical, mineral, power generation, liquified air plant, as well as port authorities, water and sewerage instrumentalities, and environmental agencies. A major class of such studies concerns itself with flow and wear studies involving industrial equipment. Some examples are discussed which illustrate the utility of radioisotope tracer techniques in these applications

  20. Building a structured monitoring and evaluating system of postmarketing drug use in Shanghai.

    Science.gov (United States)

    Du, Wenmin; Levine, Mitchell; Wang, Longxing; Zhang, Yaohua; Yi, Chengdong; Wang, Hongmin; Wang, Xiaoyu; Xie, Hongjuan; Xu, Jianglong; Jin, Huilin; Wang, Tongchun; Huang, Gan; Wu, Ye

    2007-01-01

    In order to understand a drug's full profile in the post-marketing environment, information is needed regarding utilization patterns, beneficial effects, ADRs and economic value. China, the most populated country in the world, has the largest number of people who are taking medications. To begin to appreciate the impact of these medications, a multifunctional evaluation and surveillance system was developed, the Shanghai Drug Monitoring and Evaluative System (SDMES). Set up by the Shanghai Center for Adverse Drug Reaction Monitoring in 2001, the SDMES contains three databases: a population health data base of middle aged and elderly persons; hospital patient medical records; and a spontaneous ADR reporting database. Each person has a unique identification and Medicare number, which permits record-linkage within and between these three databases. After more than three years in development, the population health database has comprehensive data for more than 320,000 residents. The hospital database has two years of inpatient medical records from five major hospitals, and will be increasing to 10 hospitals in 2007. The spontaneous reporting ADR database has collected 20,205 cases since 2001 from approximately 295 sources, including hospitals, pharmaceutical companies, drug wholesalers and pharmacies. The SDMES has the potential to become an important national and international pharmacoepidemiology resource for drug evaluation.

  1. Managing the interface with marketing to improve delivery of pharmacovigilance within the pharmaceutical industry.

    Science.gov (United States)

    Edwards, Brian

    2004-01-01

    The pharmaceutical industry is under pressure to improve the scientific quality of its decisions concerning the benefit and risks of its products while ensuring compliance with acceptable standards of marketing. All those in a pharmaceutical company who currently work within pharmacovigilance should be encouraged to lead from the front to examine ongoing marketing activities to see how they can be adapted more towards pharmacovigilance and risk management. The current irony is that the personnel who have the greatest influence on benefit-risk decisions of a product are not necessarily those who acknowledge that they are performing pharmacovigilance. Indeed, for all concerned, whether their orientation is scientific and commercial, effective communication with prescribers and consumers usually underpins product success. Also, a substantial 'marketing' budget is culturally acceptable for the pharmaceutical industry so it is logical to assume that resource for postmarketing activity is often made available. Given these realities, I suggest we should strive for an integrated marketing and risk-management plan based on the best available evidence and that being fully aware and in control of the safety issues for your products is the best way to commercialise them successfully. This approach can still be consistent with other corporate responsibilities such as trying to reduce the financial burden of product development. If this article stimulates further debate about how the pharmaceutical industry can more effectively organise resources and operations to support pharmacovigilance, risk management, and marketing, then it will have achieved its purpose.

  2. Effectiveness and safety of tolvaptan in liver cirrhosis patients with edema: Interim results of post-marketing surveillance of tolvaptan in liver cirrhosis (START study).

    Science.gov (United States)

    Sakaida, Isao; Terai, Shuji; Kurosaki, Masayuki; Yasuda, Moriyoshi; Okada, Mitsuru; Bando, Kosuke; Fukuta, Yasuhiko

    2017-10-01

    Loop diuretics and spironolactone are used in patients with hepatic edema, but they are sometimes associated with insufficient responses as well as adverse events. Tolvaptan, a vasopressin type 2 receptor antagonist, was approved for hepatic edema in 2013. A large-scale post-marketing surveillance study has been carried out to evaluate the effectiveness and safety of tolvaptan in real-world clinical settings. Patients with hepatic cirrhosis with insufficient response to conventional diuretics were enrolled. The observational period was up to 6 months. Changes in body weight and clinical symptoms were measured to evaluate effectiveness. The incidence of adverse drug reactions was summarized as a safety measure. Of 970 patients enrolled, 463 were included in the safety analysis. Of this group, 340 were included in the effectiveness analysis. Decreases in body weight from baseline were -2.38 kg on day 7 and -3.52 kg on day 14. Ascites and bloated feeling was significantly improved within 14 days. The mean change in body weight depended on estimated glomerular filtration rate levels. The most frequently reported adverse drug reaction was thirst (6.9% of patients). Serum sodium level of ≥146 mEq/L was observed in 12 patients (2.7%). In the real-world clinical setting, tolvaptan showed aquaretic effectiveness in patients with cirrhosis. The mean change in body weight depended on renal function. We recommend tolvaptan use for hepatic cirrhosis at a stage in which the renal function is maintained. © 2016 The Japan Society of Hepatology.

  3. Industry - An Urban Developer. Case Study: Iron and Steel Industry in Romania

    Directory of Open Access Journals (Sweden)

    Radu SĂGEATĂ

    2013-06-01

    Full Text Available The profound economic and social changes that took place during the period of transition from a central-based economy to the market system have deeply marked the evolution of industrial towns, particularly those targeted for heavy industry development between 1950 and 1989. The present paper analyses this model of urban evolution affected by the interference of the political-ideological factor. Three towns, Galaţi, Târgovişte and Oţelu Roşu, in which a strong iron-and-steel industry was planted, have been taken into the study. Galaţi – a large town with complex functions, a regional and crossborder polarization center, was singled out for this type of industry by political decision within the context of the industrialization drive of the 1950s; Târgovişte – an old middle urban center, was pushed into the iron-and-steel route in the 1970-1980 decade. Oţelu Roşu – a small town, has a traditional iron-and-steel industry based on local raw material resources. Relying on historical documents, bibliographical sources and field work, the author correlates urban development evolutions with the industrialization policies, highlighting the causes that have led to the present decline of these towns and the challenges facing the local authorities in revitalizing them in a sustainable manner.

  4. Leather Industry Business Linkages (Case Study in District Magetan)

    OpenAIRE

    Dilahur Dilahur

    2004-01-01

    Leather industry in Magetan covers two forms; they are tanning and leathercraft. During 1960 and 1970, the leather industry decreased in its production, but in 1990 Magetan becomes the center of leather industry. Its development appeals to be studied closely. The goals of this study are to know the relation between tanning and leathercraft, the connection between these industries and other economic ativities, and their connection with production factor. This study uses survey methhod. The res...

  5. Psychosocial functioning in patients with schizophrenia treated with aripiprazole - an office-based real-world setting. Results from the German post-marketing surveillance study.

    Science.gov (United States)

    Bergmann, F; Zacher, A; Nass, A; Urban, R; Werner, C; Spevakné-Göröcs, T; Kungel, M; Ebrecht, M; Modell, S

    2009-05-01

    Aripiprazole (ABILIFY) is an effective antipsychotic used in a dose range from 10 to 30 mg, administered once daily. Soon after its approval in Germany for treatment of schizophrenia, a 12-month post-marketing surveillance study was initiated that included 1 096 patients cared for by 408 office-based psychiatrists and/or neurologists in private practice. The aim was to gain further insights into safety and efficacy of aripiprazole in an outpatient real-life setting focusing on general health, well-being and psychosocial functioning. Efficacy was rated by using standard CGI, SF-12 and SIWM-PsySo instruments for severity of disease, physical and mental health outcomes and psychosocial state, respectively. Safety was evaluated according to the reports of adverse events. Mean total daily dose of aripiprazole increased from 15.4 mg at the visit after 1 month to 17.6 mg at the visits after 6 to 12 months, the most frequently administered maintenance dose being 15 mg. Within the observation period significant improvements of CGI, SF-12 and SIWM-PsySo scores over time versus baseline values were observed (pmuch" or "very much" improved. Aripiprazole was overall well tolerated; 19.9% of patients discontinued treatment after 12 months. Adverse effects in general were moderate to mild and corresponded to the known tolerability profile of aripiprazole. Psychotic side effects reported were probably due to a recurrence of the underlying schizophrenic disorder. The results indicate that aripiprazole may be an efficacious and safe treatment option for pre-treated patients with schizophrenia also in a naturalistic psychiatrist/neurologist practice setting with effects on health and psychosocial functioning and a comparably low dropout rate.

  6. An anthropometric study of Serbian metal industry workers.

    Science.gov (United States)

    Omić, S; Brkić, V K Spasojevic; Golubović, T A; Brkić, A D; Klarin, M M

    2017-01-01

    There are recent studies using new industrial workers' anthropometric data in different countries, but for Serbia such data are not available. This study is the first anthropometric study of Serbian metal industry workers in the country, whose labor force is increasingly employed both on local and international markets. The metal industry is one of Serbia's most important economic sectors. To this end, we collected the basic static anthropometric dimensions of 122 industrial workers and used principal components analysis (PCA) to obtain multivariate anthropometric models. To confirm the results, the dimensions of an additional 50 workers were collected. The PCA methodology was also compared with the percentile method. Comparing both data samples, we found that 96% of the participants are within the tolerance ellipsoid. According to this study, multivariate modeling covers a larger extent of the intended population proportion compared to percentiles. The results of this research are useful for the designers of metal industry workstations. This information can be used in dimensioning the workplace, thus increasing job satisfaction, reducing the risk of injuries and fatalities, and consequently increasing productivity and safety.

  7. Qualitative study on maintenance management in Moroccan industries

    Science.gov (United States)

    Naji, Amal; El Oumami, Mohamed; Bouksour, Otmane; Beidouri, Zitouni

    2018-05-01

    Maintenance management is, and has been studied in depth, especially for strategies to be implemented in industry, even though, authors note that there is a gap between literature and management adopted by industries. In this paper, we present a qualitative study in five Moroccan industries to investigate “how maintenance is managed” rather than “how it should be”. The questionnaire utilized for the study consists on semi-structured and open-ended questions. We consider factors and variables related to maintenance management and we explore the relationships between those factors. The original contribution of this paper is to provide a «real view »about maintenance management in Moroccan industries, which could help to improve understanding of barriers to implementing maintenance strategy.

  8. Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report

    Science.gov (United States)

    Terao, Takeshi; Ishida, Atsuko; Kimura, Toshifumi; Yoshida, Mitsuhiro; Hara, Terufumi

    2017-01-01

    Background A post-marketing surveillance (PMS) study was conducted with a 1-year observation period to assess the safety and efficacy of lamotrigine in routine clinical practice in patients with bipolar disorder (BD). Patients and methods Central enrollment method was used to recruit patients diagnosed with BD who were being treated for the first time with lamotrigine to prevent the recurrence/relapse of BD mood episodes. Adverse drug reactions (ADRs) and recurrence/relapse were assessed. Improvement of mania and depression was also assessed using the Hamilton’s Rating Scale for Depression (HAM-D) and the Young Mania Rating Scale (YMRS) at treatment initiation, 4–6 months post treatment initiation, and 10–12 months post treatment initiation. Results A total of 237/989 patients (24.0%) reported ADRs, most commonly rash (9.1%), and the incidence of serious ADRs was 3.3% (33/989 patients). Skin disorders occurred in 130 patients (13.1%), mostly within 8 weeks post treatment. A total of 237/703 patients (33.7%) experienced recurrence/relapse of mood episodes. The 25th percentile of the time to recurrence/relapse of mood episodes was 105 days. Remission of depression symptoms (HAM-D ≤7) occurred in 147/697 patients (21.1%) at treatment initiation, rising to 361 patients (67.4%) at 10–12 months post treatment. Remission of manic symptoms (YMRS ≤13) occurred in 615/676 patients (91.0%) at treatment initiation, rising to 500 patients (97.3%) at 10–12 months post treatment. Conclusion The results of this PMS study suggest that lamotrigine is a well-tolerated and effective drug for preventing recurrence/relapse of BD in clinical practice. PMID:28652744

  9. Industrial process heat case studies. [PROSYS/ECONMAT code

    Energy Technology Data Exchange (ETDEWEB)

    Hooker, D.W.; May, E.K.; West, R.E.

    1980-05-01

    Commercially available solar collectors have the potential to provide a large fraction of the energy consumed for industrial process heat (IPH). Detailed case studies of individual industrial plants are required in order to make an accurate assessment of the technical and economic feasibility of applications. This report documents the results of seven such case studies. The objectives of the case study program are to determine the near-term feasibility of solar IPH in selected industries, identify energy conservation measures, identify conditions of IPH systems that affect solar applications, test SERI's IPH analysis software (PROSYS/ECONOMAT), disseminate information to the industrial community, and provide inputs to the SERI research program. The detailed results from the case studies are presented. Although few near-term, economical solar applications were found, the conditions that would enhance the opportunities for solar IPH applications are identified.

  10. 32nd European Study Group with Industry, Final Report

    DEFF Research Database (Denmark)

    ESGI (European Study Group with Industry) is Europe's leading workshop for interaction between mathematicians and industry. These workshops have taken place in Great Britain for a number of years, going back to 1968 when Prof. Alan Tayler initiated the so-called Oxford Study Group with Industry...

  11. Leather Industry Business Linkages (Case Study in District Magetan

    Directory of Open Access Journals (Sweden)

    Dilahur Dilahur

    2004-01-01

    Full Text Available Leather industry in Magetan covers two forms; they are tanning and leathercraft. During 1960 and 1970, the leather industry decreased in its production, but in 1990 Magetan becomes the center of leather industry. Its development appeals to be studied closely. The goals of this study are to know the relation between tanning and leathercraft, the connection between these industries and other economic ativities, and their connection with production factor. This study uses survey methhod. The respondents are taken proportionally from both of those leather industries. The data is obtained inetrviewing the respondents with questionnaire that related to the input and out put of the industry. The result of this study shows that there is no relationship between the kind of industries (small and household industry and its capital, especially in its raw material (44,44%. The relationship between tanning and leathercraft is low, because it is only 24,2% input of leathercraft which taken from output of tanning. The region relationship for tanning is larger, because the products that are sold to other regions are 97,22% for tanning and 68,29% for leathercraft. Its relationship to other sectors especially for labour supply is 56,48% from farming and trade sectors in marketing.

  12. System analysis of industrial waste management: A case study of industrial plants located between Tehran and Karaj

    OpenAIRE

    Mohammad Amin Karami; Mohsen Sadani; Mehdi Farzadkia; Nezam Mirzaei; Anvar Asadi

    2015-01-01

    Aims: In this study, management of industrial waste in industries located between Tehran and Karaj in 2009-2010 was examined. Materials and Methods: This is a cross-sectional study which was done by site survey (Iranian environmental protection organization) questionnaire usage and results analysis. This questionnaire was consisted of 45 questions about industrial waste, quantity, quality, and management. A total number of industries with over 50 employees was 283, and Stratified sampling...

  13. A study of polluted eco-system around industrial areas

    International Nuclear Information System (INIS)

    Husaini, S.N.; Khan, E.U.; Qureshi, I.E.; Malik, F.; Zaidi, J.H.; Arif, M.; Fatima, I.; Arif, M.

    2005-01-01

    Industrial pollution is one of the most serious problems in Pakistan. The uncontrolled release of untreated industrial effluents to large water bodies has deleterious effects on water quality, aquatic life and human health. The concentration of heavy metals in eco-system is reaching at alarming levels and is increasing yearly. In reality, the industries are not equipped with proper effluent treatment plants. The environmental protection law is not strictly implemented to limit the release and/or proper disposal of industrial effluents. Therefore, volume of specified industrial discharge is growing at an exponential rate without any specific safeguards. Effective measures, which can eliminate or considerably reduce hazardous factors from the human environment to minimize the associated health risks, must be identified and eradicated. In order to achieve these objectives, the study has been done to reach a balanced assessment of the risks and benefits involved. For this purpose two industrial cities of Pakistan namely, Gujranwala and Faisalabad have been selected. Four major industries existing in these cities, namely Yam, textile, paper and board and ceramics, have been studied. The specimens of the irrigated soil exposed to the industrial effluent, crops and vegetables grown on that soil have been analyzed study the hazardous effects on human health. (author)

  14. Electronics Industry Study Report

    National Research Council Canada - National Science Library

    Belt, David; Fellows, John R; Kameru, Philip; Nazaroff, Boris-Frank A; Pauroso, Anthony; Schulz, Frederick; Ballew, Bob; Bond, Thomas; Demers, Stephy; Kirkpatrick, Steve

    2005-01-01

    This paper provides a national strategy for the US electronics industry. Electronics is one of the largest industries in the US and plays a critical role in almost every aspect of national security...

  15. Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance.

    Science.gov (United States)

    Sessa, Maurizio; Rossi, Claudia; Mascolo, Annamaria; Grassi, Enrico; Fiorentino, Sonia; Scavone, Cristina; Reginelli, Alfonso; Rotondo, Antonio; Sportiello, Liberata

    2015-01-01

    During the last years in Italy, contrast media (CM) use increased. An increase of monitoring activities on CM-induced adverse drug reaction (ADR) is necessary, also in our regional territory. The main aim of this study was to give a preliminary evaluation of all Spontaneous Reports of ADRs (SRA) attributed to CM sent to Campania Pharmacovigilance Regional Center (CRFVC) from 01 January 2001 to 31 October 2014. For each SRA we evaluated: frequency and source, ADRs onset (time to event, seriousness and outcome), socio-demographic characteristics and risk factors of cases, the most reported CM (checking for pharmacodynamic and pharmacokinetic interactions). A total of 111 SRA were sent to CRFVC; specialist in radiology was the main source of reports. Ninety-seven SRA (87.3%) were referable to hypersensitivity reactions. Thirty-four SRA (30.6%) reported serious ADRs. The most reported CM were iopamidol, gadobenic acid and gadoteric acid. We identified two SRA induced by pharmacokinetic and/or pharmacodynamic interactions. During 14 years of post-marketing surveillance, only few SRA concerning CM-induced ADRs were sent to CRFVC probably due to underreporting. We aim to improve monitoring activity on CM-induced ADRs especially in hospitals. Most reported ADR and CM were in line with current body of literature.

  16. Safety and effectiveness of 24-week treatment with iguratimod, a new oral disease-modifying antirheumatic drug, for patients with rheumatoid arthritis: interim analysis of a post-marketing surveillance study of 2679 patients in Japan.

    Science.gov (United States)

    Mimori, Tsuneyo; Harigai, Masayoshi; Atsumi, Tatsuya; Fujii, Takao; Kuwana, Masataka; Matsuno, Hiroaki; Momohara, Shigeki; Takei, Syuji; Tamura, Naoto; Takasaki, Yoshinari; Ikeuchi, Satoshi; Kushimoto, Satoru; Koike, Takao

    2017-09-01

    To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, post-marketing surveillance study was conducted. An interim analysis at week 24 was performed. This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24. Safety was analyzed in 2679 patients. The overall incidences of AEs, ADRs, and serious ADRs were 38.41, 31.65, and 3.21%, respectively; the most commonly reported serious ADRs were pneumonia/bacterial pneumonia, interstitial lung disease, and Pneumocystis jiroveci pneumonia. Concomitant glucocorticoid use and comorbid conditions associated with respiratory disease were identified as risk factors for serious infections. Pulmonary alveolar hemorrhage and increased international normalized ratio of prothrombin time were observed with concomitant use of IGU and warfarin. The DAS28-CRP decreased from baseline to week 24. Although a safety concern was identified with concomitant use of IGU and warfarin, this real-world study showed no other new safety concerns and similar effectiveness to clinical trials. IGU is a new therapeutic option for RA patients.

  17. ANALISIS SISTEM PENGEMBANGAN KAWASAN INDUSTRI TERPADU BERWAWASAN LINGKUNGAN: STUDI KASUS DI PT. KAWASAN INDUSTRI MEDAN (Analysis System of Integrated Industrial Estate Ecodevelopment Case Study: At PT. Medan Industrial Estate

    Directory of Open Access Journals (Sweden)

    Kimberly Febrina Kodrat

    2011-07-01

    Full Text Available ABSTRAK Tujuan utama penelitian adalah menganalisis kinerja pengembangan kawasan industri terpadu berwawasan lingkungan. Cakupan aspek penelitian disinkronkan dengan konsep pembangunan berkelanjutan sekaligus dijadikan sebagai batasan kajian, yakni mempersekutukan aspek ekonomi, ekologi dan sosial. Data diperoleh dengan menggunakan metode survei melalui observasi, wawancara mendalam, dan pendapat pakar. Metodologi penelitian menggunakan metode survei dengan menggunakan perpaduan antara hard system (analisis sistem dinamis dan soft system (analisis prospektif. Dari hasil uji statistik chi square (α = 0,01 diperoleh bahwa kelompok masyarakat yang bekerja di dalam PT. KIM mempunyai hubungan yang sangat signifikan dengan kelompok masyarakat yang bekerja di luat PT. KIM terhadap tingkat pendapatan, tingkat pendidikan dan faktor usia. Berdasarkan hasil analisis kualitas limbah cair unit IPAL PT. KIM terdapat 5 parameter yang masih berada diatas nilai baku mutu KepMenLHNo.51/1997, yaitu: BOD, COD, TSS, klorida dan amoniak. Tingkat efisiensi pengolahan limbah cair unit IPAL PT. KIM rata-rata 53,07%. Hasil analisis ketergantungan antar faktor dengan menggunakan Analisis Prospektif diperoleh sebanyak 5 faktor strategis masa depan yang mempengaruhi pengembangan kawasan industri terpadu berwawasan lingkungan, yaitu: jumlah industri, permintaan lahan, kebijakan pemerintah, model pengembangan, dan iklim investasi yang kondusif. Pengembangan kawasan industri terpadu berwawasan lingkungan dapat dilakukan dengan strategi moderat dengan kebijakan mencakup jumlah industri bertambah secara bertahap dengan meningkatnya permintaan lahan serta kebijakan pemerintah yang memfasilitasi peningkatan modal pengembangan dan didukung oleh iklim investasi yang kondusif. ABSTRACT The main purpose of the research is to study environmental aspect of industrial estate development. The scope of the research aspects is synchronized with sustainable development concepts, namely

  18. System analysis of industrial waste management: A case study of industrial plants located between Tehran and Karaj

    Directory of Open Access Journals (Sweden)

    Mohammad Amin Karami

    2015-01-01

    Full Text Available Aims: In this study, management of industrial waste in industries located between Tehran and Karaj in 2009-2010 was examined. Materials and Methods: This is a cross-sectional study which was done by site survey (Iranian environmental protection organization questionnaire usage and results analysis. This questionnaire was consisted of 45 questions about industrial waste, quantity, quality, and management. A total number of industries with over 50 employees was 283, and Stratified sampling method was used. Sample of size 50 was selected from 283cases. Results: The major hazardous waste-generating industries include chemical and plastic. Private sectors disposed 45% of generated waste. Majority of wastes were buried (62%, and only 17% of industrial waste was recycled. Conclusion: For hazardous waste reduction in this zone and health and economic attractions, the opportunity for reuse and recovery for these wastes must maximize in short-term and burial of industrial waste must be minimized. Industries such as chemical-plastic and electronics which have higher hazardous waste, in long-term, must be replaced with other industries such as wood cellulose and paper that have lower hazardous waste production rate.

  19. Long-term post-marketing surveillance of mizoribine for the treatment of lupus nephritis: Safety and efficacy during a 3-year follow-up

    Directory of Open Access Journals (Sweden)

    Nobuyuki Yagi

    2014-05-01

    Full Text Available Objective: To determine the safety and efficacy of long-term use of mizoribine by undertaking a 3-year post-marketing surveillance study. Methods: Subjects were all lupus nephritis patients newly treated with mizoribine between 1 October 2003 and 30 September 2005 at contracted study sites. Results: Mizoribine was administered to 881 lupus nephritis patients in the safety analysis set consisting of 946 patients recruited from 281 contracted study sites after satisfying the eligibility criteria. There were 301 events of adverse drug reactions that were observed in 196 (20.7% of the 946 subjects. There were 34 events of serious adverse drug reactions in 31 patients (3.2%. No deterioration in hematological and biochemical test values was observed, but immunological testing showed significant improvements in C3, CH50, and anti-DNA antibody titers. The negative rate of proteinuria also increased over time. The median steroid dosage was 15 mg/day at the commencement of treatment, but was reduced to 10 mg/day at 12 months and 8 mg/day at 36 months. Conclusion: The findings of the 3-year long-term drug use surveillance study indicated that mizoribine can be used over the long term with relatively few adverse drug reactions, suggesting its suitability for use in maintenance drug therapy.

  20. Industrial radioisotope economics. Findings of the study group

    International Nuclear Information System (INIS)

    1965-01-01

    Within twenty years of the availability of radioisotopes in quantity the use of these as tracers has been widely applied in scientific research and in industrial process and product control. Industry spends millions of dollars on these new techniques. Since the overall attitude of industry is to favour methods that involve rapid financial returns the economic benefits must be considerable. In promoting the peaceful uses of atomic energy, the IAEA is actively interested in the international exchange of experience in all applications of radioisotopes. This has been demonstrated by a number of scientific conferences where new results of direct importance to the industrial use of radioisotopes have been presented. In 1963 the IAEA also published literature survey on radioisotope applications described in the scientific literature up to 1960, classified according to industry. However, the available scientific literature was found insufficient to determine the extent of the use of radioisotopes and the economic benefits derived from it. Therefore, further fact-finding efforts were necessary. The IAEA thus decided to carry out an International Survey on the Use of Radioisotopes in Industry. In 1962 the IAEA's highly industrialized Member States Were invited to participate in the Survey; 25 declared their willingness to do so and in due course submitted their national reports. These included information on how radioisotopes were used by industry in each country and indicated the size and form of the economic advantages, primarily in terms of savings made by industry. The findings from the Survey were discussed at a Study Group Meeting on Radioisotope Economics, held in Vienna in March 1964. Forty participants from 22 countries were nominated for this Study Group. The program of the meeting was divided in three parts: (1) experience of the International Survey on the use of radioisotopes in industry; (2) present use of radioisotopes, technical and economic aspects; (3

  1. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing phase IV study

    Directory of Open Access Journals (Sweden)

    Bashaireh K

    2015-04-01

    Full Text Available Khaldoon Bashaireh,1 Ziad Naser,2 Khaled Al Hawadya,2 Sorour Sorour,2 Rami Nabeel Al-Khateeb3 1Department of Orthopedics Surgery, King Abdullah University Hospital, Jordan University of Science and Technology, Irbid, Jordan; 2Private Clinic, 3Elaf Medical Supplies Company, Amman, Jordan Purpose: The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period.Materials and methods: The study was a post-marketing phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1–4 in the tibio–femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection.Main outcome measure(s: An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated.Main results: The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3

  2. Study fidelity spatial contours of industrial robots

    Directory of Open Access Journals (Sweden)

    A. V. Ivanova

    2014-01-01

    Full Text Available The purpose of this paper to identify deviations fidelity spatial contours of industrial robots, determine the error pattern detected, and define the ways to solve the problem.The paper presents the research results of fidelity spatial contours done by Fanuc M- 710iC/50 industrial robot when moving along a predetermined path. The proposed method uses a QC20-W ballbar wireless system of Renishaw company, designed to diagnose the state of the measurement and playback linear and angular displacements of the CNC.The solutions to adapt the QC20-W ballbar system to the constructive peculiarities of industrial robots with five or more independently controlled axes are given. The stages of the preparation of diagnostic systems and software robot movements are described.According to study results of errors that arise while playing back the programmed motions of a fixed point of robot capture in three mutually perpendicular planes its practical accuracy has been defined when performing movements in a given region of the working area, thereby allowing us, eventually, to draw a conclusion on the possibility to use a robot in one technological process or another.The study has resulted in emerging the guidelines for the operation of industrial robots with five or more independently controlled axes. Using these guidelines enables us to increase the playback accuracy of the industrial robot to 0.01 mm.

  3. Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations.

    Science.gov (United States)

    Wang, Can; Shi, Qing-Ping; Ding, Feng; Jiang, Xiao-Dong; Tang, Wei; Yu, Mei-Ling; Zhu, Jian-Hua

    2018-01-01

    To evaluate the factors influencing suspected hypersensitivity and adverse systemic reactions after Shuxuening injection and to provide innovative ideas and methods for the reevaluation of post-marketing safety of Shuxuening. This study used a prospective, nested case-control study design, combined with a prescription sequence analysis design method. It classified patients who exhibited trigger signals after administration of Shuxuening injection as suspected allergic patients and made comparisons with patients who did not report adverse effects to calculate the correlation between relevant risk factors and suspected allergic reactions. Randomized controlled studies and cohort studies of the adverse drug reaction (ADR) of Shuxuening were performed using a computer database. Data retrieval was carried out by the foundation governing the individual database. Meta-analysis was performed by using R3.2.3 software to evaluate the ADRs of Shuxuening. The results of real-world study showed that administration of Shuxuening in combination with potassium aspartate and magnesium, atorvastatin calcium, Shengmai injection, pantoprazole sodium, or high-dose medication was a risk factor for suspected allergic reactions. Meta-analysis showed that the incidence of adverse events was 5.84% (95% CI 0.0499; 0.0674), and serious adverse reaction rate was 4.36% (95% CI 0.0188; 0.0760) when Shuxuening was used in combination with these drugs. The incidence of allergic reaction was also influenced by the vehicle, duration of treatment, single dose, and indicated vs off-label use. Risk factors for adverse reaction following the use of Shuxuening injection in patients are associated with a single dose, vehicle, type of disease, and combination with potassium aspartate, atorvastatin calcium, Shengmai injection, injection with pantoprazole sodium, and other drugs. Physicians should be careful to follow guidelines when administering this drug. We further propose that the unique methodology

  4. Barriers to Industrial Energy Efficiency - Study (Appendix A), June 2015

    Energy Technology Data Exchange (ETDEWEB)

    None

    2015-06-01

    This study examines barriers that impede the adoption of energy efficient technologies and practices in the industrial sector, and identifies successful examples and opportunities to overcome these barriers. Three groups of energy efficiency technologies and measures were examined: industrial end-use energy efficiency, industrial demand response, and industrial combined heat and power. This study also includes the estimated economic benefits from hypothetical Federal energy efficiency matching grants, as directed by the Act.

  5. Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term post-marketing safety surveillance.

    Science.gov (United States)

    Goddard, Allison; Borovicka, Judy H; West, Dennis P; Evens, Andrew M; Laumann, Anne

    2011-01-01

    This case report describes a patient who developed diffuse large B-cell lymphoma (DLBCL) after receiving courses of two investigational biologic agents and cyclosporine followed by more than four years of subcutaneous efalizumab for the treatment of extensive chronic plaque psoriasis. Three years later, the patient remains free of lymphoma and his psoriasis is well controlled with thrice-weekly narrow-band ultraviolet phototherapy. This case emphasizes the importance of continued long-term post-marketing safety surveillance and the early reporting of all possible serious side effects, including cancers, related to the use of any newly available product. In particular, surveillance should focus on the immunomodulating biologic agents in order to identify possible dangerous sequelae.

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

    Science.gov (United States)

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

    2012-01-01

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

  7. Three Studies in Industrial Economics: Competition and Industry Structure

    Science.gov (United States)

    Keil, Jan

    Chapter 1 reviews alternative theories of competition - the standard Neoclassical view, the contribution of the Chicago School as well as the two dynamic lines of thought which are part of Austrian economics and Classical Political Economy. The latter is presented as a consistent alternative to the other existing theories. Of special interest is the question if and how industry structure matters in these approaches, how profitability differentials are explained and what role market share concentration and mobility barriers play. Their predictions and implications for empirical research are compared. Ways to test and evaluate these different approaches are described. Chapter 2 investigates econometrically how industry and micro level variables determine persistent differentials in the rate of return on assets in the U.S. The analysis is the first to use business segment data to explain long term profitability differentials. It presents new market concentration indicators that are superior to concentration ratios and allow to analyze an unpreceded amount of concentration and other data back to 1977. Critical concentration levels, non-linearities, interaction effects and previously ignored important control variables like industrial unionization are being considered. Concentration is found to have significant negative effects on profitability differentials. Barrier indicators are insignificant while market shares are positively correlated with long-run profitability. Concentration thus increases, not diminishes the degree of industrial competition. This is interpreted as evidence in support of Classical Political Economic competition theory. Chapter 3 presents a costs of production based industry analytical study that aims at consistency with Classical Political Economic thought. It investigates how growth of renewable electricity in Germany forces conventional power plants to shift towards more flexible operating regimes. The simulation of individual power plant load

  8. Industrial College of the Armed Forces Industry Studies 2002: Biotechnology

    National Research Council Canada - National Science Library

    2002-01-01

    The biotechnology industry is critically important to the development of products that will improve health care, agriculture, industrial processes, environmental remediation, and biological defense...

  9. The applicability of animal health surveillance systems for post-market monitoring of potential adverse effects of genetically modified (GM) feed.

    Science.gov (United States)

    Vince, L; Kleter, G A; Kostov, K; Pfeiffer, D U; Guitian, J

    2018-04-20

    A facultative post market monitoring of potential health impacts of genetically modified (GM) feedstuffs on livestock consuming these feeds after pre-market risk assessment is under ongoing consideration. Within the IPAFEED database, scientific studies on health effects beyond performance in livestock and the results of a systematic search for evidence of outcome effects due to GM feed are consolidated. These outcomes were reviewed and checked for consistency in order to identify plausible syndromes suitable for conducting surveillance. The 24 selected studies showed no consistent changes in any health parameter. There were no repeated studies in any species by GM crop type and animal species. As such, there is insufficient evidence to inform the design of surveillance systems for detecting known adverse effects. Animal health surveillance systems have been proposed for the post market monitoring of potential adverse effects in animals. Such systems were evaluated for their applicability to the detection of hypothetical adverse effects and their strengths and weaknesses to detect syndromes of concern are presented. For known adverse effects, applied controlled post-market studies may yield conclusive and high-quality evidence. For detecting unknown adverse effects, the use of existing surveillance systems may still be of interest. A simulation tool developed within the project can be adapted and applied to existing surveillance systems to explore their applicability to the detection of potential adverse effects of GM feed. Copyright © 2018. Published by Elsevier Ltd.

  10. A theoretical study of solvent effects on the characteristics of the ...

    Indian Academy of Sciences (India)

    adrenaline).25 Unlike norepinephrine and epinephrine themselves, L-DOPS is capable of crossing the protective blood–brain barrier (BBB).25. Data from clinical studies and post-marketing surveil- lance programs conducted in Japan show that the.

  11. 2002 Industry Studies: Energy

    Science.gov (United States)

    2002-01-01

    Information technologies have facilitated the rapid growth of electronic market places across the energy industry for trading energy commodities, such as...and information technology industry has further increased the importance of abundant, low-cost, and reliable electric power. Recently, public...California, the country has recently slowed its efforts to make electricity markets more competitive. Recommendations. Unless some technological “silver bullet

  12. Industry Study, Electronics Industry, Spring 2009

    Science.gov (United States)

    2009-01-01

    not have the flexibility in their processes to quickly produce custom system-on-chips because they are optimized for high-end production. Dell ...building its semiconductor industry, Malaysia has moved in the same overall directions but has lagged a few years. Malaysia has succeeded in the backend

  13. [Investigation of the factors that contribute to the onset of insomnia in hypertensive patients by using a post-marketing surveillance database].

    Science.gov (United States)

    Tanabe, Naoto; Fujita, Toshiharu; Fujii, Yosuke; Orii, Takao

    2011-01-01

    Many factors contribute to the onset of insomnia. However, few studies have identified the factors related to the onset of insomnia in hypertensive patients. We conducted a pharmacoepidemiologic study to examine the incidence of insomnia in hypertensive patients by using a post-marketing surveillance database. The insomnia onset was defined as the time of first prescription of hypnotics. The insomnia incidence rate in hypertensive patients under antihypertensive therapy was 0.77/100 person-years. The median insomnia onset date was 5 weeks. The insomnia type in 50.2% of the patients was difficulty in initiating sleep. We assessed the factors contributing to insomnia by using a nested case-control design. We selected 10 time-matched controls for every case. The hypotensive effect induced by antihypertensive therapy on the case group was lesser than that on the control group (pchannel blockers (OR, 0.62; 95% CI, 0.43-0.90) compared with angiotensin-converting enzyme inhibitors; female sex (OR, 1.76; 95% CI, 1.27-2.44); complication of gastric/duodenal disorders (OR, 2.35; 95% CI, 1.14-4.86) or musculoskeletal system/connective tissue disorders (OR, 2.43; 95% CI, 1.23-4.79); and concomitant antihypertensive therapy (OR, 0.44; 95% CI, 0.31-0.63). This study identified the potential factors that may help to predict insomnia onset in hypertensive patients under antihypertensive therapy.

  14. Analysis of postmarket complaints database for the iFuse SI Joint Fusion System®: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption.

    Science.gov (United States)

    Miller, Larry E; Reckling, W Carlton; Block, Jon E

    2013-01-01

    The sacroiliac joint is a common but under-recognized source of low back and gluteal pain. Patients with degenerative sacroiliitis or sacroiliac joint disruption resistant to nonsurgical treatments may undergo open surgery with sacroiliac joint arthrodesis, although outcomes are mixed and risks are significant. Minimally invasive sacroiliac joint arthrodesis was developed to minimize the risk of iatrogenic injury and to improve patient outcomes compared with open surgery. Between April 2009 and January 2013, 5319 patients were treated with the iFuse SI Joint Fusion System® for conditions including sacroiliac joint disruption and degenerative sacroiliitis. A database was prospectively developed to record all complaints reported to the manufacturer in patients treated with the iFuse device. Complaints were collected through spontaneous reporting mechanisms in support of ongoing mandatory postmarket surveillance efforts. Complaints were reported in 204 (3.8%) patients treated with the iFuse system. Pain was the most commonly reported clinical complaint (n = 119, 2.2%), with nerve impingement (n = 48, 0.9%) and recurrent sacroiliac joint pain (n = 43, 0.8%) most frequently cited. All other clinical complaints were rare (≤0.2%). Ninety-six revision surgeries were performed in 94 (1.8%) patients at a median follow-up of four (range 0-30) months. Revisions were typically performed in the early postoperative period for treatment of a symptomatic malpositioned implant (n = 46, 0.9%) or to correct an improperly sized implant in an asymptomatic patient (n = 10, 0.2%). Revisions in the late postoperative period were performed to treat symptom recurrence (n = 34, 0.6%) or for continued pain of undetermined etiology (n = 6, 0.1%). Analysis of a postmarket product complaints database demonstrates an overall low risk of complaints with the iFuse SI Joint Fusion System in patients with degenerative sacroiliitis or sacroiliac joint disruption.

  15. Spring 2007. Industry Study. Manufacturing Industry

    Science.gov (United States)

    2007-01-01

    their success. Each company advertised the world-class capabilities of their product, not its price. By contrast, a struggling company we visited in...business disruptions lurking within the Trojan Horse we have nestled in the US industrial base. It is important to note that a catastrophic disaster from

  16. A Critical Study of Vocational-Industrial Education in Taiwan.

    Science.gov (United States)

    Koo, Po-Ken

    This study was concerned with determining the kind of vocational-industrial educational programs that would best suit the needs of Taiwan. The general conditions and provisions of 27 existing vocational-industrial programs were studied to determine their strengths and weaknesses and to provide a set of principles that would serve as guideposts for…

  17. Transitioning from first- to second-generation biosimilars: An appraisal of regulatory and post-marketing challenges.

    Science.gov (United States)

    Blandizzi, Corrado; Galeazzi, Mauro; Valesini, Guido

    2018-02-01

    Second-generation biosimilars (i.e. monoclonal antibodies or proteins generated by fusion of antibody and receptor moieties) differ in several respects as compared to first-generation ones (e.g. epoetins, bone marrow stimulating factors, somatotropins). In this respect, as second-generation biosimilars are endowed with much greater structural and molecular complexity, which might translate into a number of pharmacological and therapeutic issues, they raise new challenges for manufacturers and regulatory authorities as well as new concerns for clinicians. Based on these arguments, the present article was intended to review information on the main differences between first- and second-generation biosimilars for treatment of immune-mediated inflammatory diseases, as well as their impact on immunogenicity, the design of clinical trials and the critical issue of extrapolation of therapeutic indications. The positions taken by relevant medical associations and the crucial role of pharmacovigilance are also reviewed. According to current knowledge, the initial post-marketing clinical experience with second-generation biosimilars is providing encouraging results, though their long-term safety and efficacy as well as the scientific basis underlying the extrapolation of therapeutic indications are still matter of discussion. There is some consensus that marketing applications should rely on studies supporting the clinical use of biosimilars in their different target diseases and patient populations. In parallel, clinical safety must be ensured by a strict control of the manufacturing processes and a solid pharmacovigilance program. It remains then a responsibility of the physician to drive a proper use of second-generation biosimilars into clinical practice, in accordance with guidelines issued by scientific societies. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  18. ICAF Financial Services Industry Study

    National Research Council Canada - National Science Library

    Allison, Douglas; Barry, Kevin; Beaver, Philip; Browne, Michael; Cubillos, Claudio; Hanger, Wallace; Kluchko, Luke; LaDue, Charles; McGhee, Michael; Mitsoff, Gregory

    2005-01-01

    .... The industry includes those firms that provide financial services to organizations or individuals, the government agencies that regulate the industry, and the markets that facilitate the exchange of financial assets...

  19. Study of industry safety management

    International Nuclear Information System (INIS)

    Park, Pil Su

    1987-06-01

    This book deals with general remarks, industrial accidents, statistics of industrial accidents, unsafe actions, making machinery and facilities safe, safe activities, having working environment safe, survey of industrial accidents and analysis of causes, system of safety management and operations, safety management planning, safety education, human engineering such as human-machines system, system safety, and costs of disaster losses. It lastly adds individual protective equipment and working clothes including protect equipment for eyes, face, hands, arms and feet.

  20. Energy analysis of 108 industrial processes. Phase 1, industrial applications study

    Energy Technology Data Exchange (ETDEWEB)

    Hamel, B. B.; Brown, H. L.

    1979-06-01

    Extensive data are compiled for energy balances in 108 industrial processes. Specific information on unit operation, material, temperature, unrecoverable losses, along with the process flow diagram is given for each of the industries. The following industries are included: meak packing; milk; canned fruits and vegetables; baked goods; sugar refining; soybean; textiles; wood products; building materials; alkalies and chlorine; inorganic gases; pigments, chemicals; plastic materials and resins; synthetic rubbers; organic fibers; pharmaceutical preparations; organic chemicals; petroleum products; fertilizers; rubber products; glass; blast furnaces and steel mills; metals; farm machinery; motor vehicles; and photographic materials. The SIC's for each industry are identified.

  1. 2001 Industry Studies: Environment

    Science.gov (United States)

    2001-01-01

    Internet . 8 March 2001. xliii Henry Kelly, “ Information Technology and the Environment: Choices and Opportunities,” CISP.org (October 1999) pp 8...development. Despite only a small percentage of U.S. environmental businesses participating in the world market , the U.S. industry has the best technology ...businesses participating in the world market , the U.S. industry has the best technology in the world and already generates a trade surplus. With the world

  2. Spring 2008 Industry Study: Financial Services Industry

    National Research Council Canada - National Science Library

    Calderon, Juan; Collins, Thomas W; Devinney, Edward; Driggers, Gene J; Dunmyer, Valrica; Flood, Paul; Gallant, Robin; Kekauoha, Stanford K; Krawietz, Anthony B; Kumashiro, Patrick T; LaDue, Paul W; LaFalce, John; Larson, Steven W; Lawrence, Steven J; Nettleton, John; Ostrowski, John A

    2008-01-01

    The extensive media coverage of the 2008 subprime crisis, both domestically and abroad, drives home the crucial role that the financial services industry plays for not only individual Americans, but for U.S. national security...

  3. Industry Study, Weapons Industry, Spring 2009

    Science.gov (United States)

    2009-01-01

    Agencies Sdn. Bhd.; Malaysia Aircraft Inspection, Repair, and Overhaul Depot; Malaysia American Malaysian Chamber of Commerce; Malaysia Samsung Techwin...Ministry of Defense: Defense Science and Technology Agency; Singapore Ministry of Defense: Industrial Affairs Office; Malaysia Boustead Shipping...Singapore, Malaysia , and Korea). Recommended policy changes included in the conclusion will strengthen these conditions, given that government goals and

  4. A Study on the Evaluation of Industrial Solid Waste Management ...

    African Journals Online (AJOL)

    Industrial solid waste is a serious health concern in Aba, South East Nigeria. This study was undertaken to assess the approaches of some industries toward some aspects of waste management in Aba. Interviews, observation and questionnaires administered to industry executives and waste managers were used to ...

  5. Environmental change challenges decision-making during post-market environmental monitoring of transgenic crops.

    Science.gov (United States)

    Sanvido, Olivier; Romeis, Jörg; Bigler, Franz

    2011-12-01

    The ability to decide what kind of environmental changes observed during post-market environmental monitoring of genetically modified (GM) crops represent environmental harm is an essential part of most legal frameworks regulating the commercial release of GM crops into the environment. Among others, such decisions are necessary to initiate remedial measures or to sustain claims of redress linked to environmental liability. Given that consensus on criteria to evaluate 'environmental harm' has not yet been found, there are a number of challenges for risk managers when interpreting GM crop monitoring data for environmental decision-making. In the present paper, we argue that the challenges in decision-making have four main causes. The first three causes relate to scientific data collection and analysis, which have methodological limits. The forth cause concerns scientific data evaluation, which is controversial among the different stakeholders involved in the debate on potential impacts of GM crops on the environment. This results in controversy how the effects of GM crops should be valued and what constitutes environmental harm. This controversy may influence decision-making about triggering corrective actions by regulators. We analyse all four challenges and propose potential strategies for addressing them. We conclude that environmental monitoring has its limits in reducing uncertainties remaining from the environmental risk assessment prior to market approval. We argue that remaining uncertainties related to adverse environmental effects of GM crops would probably be assessed in a more efficient and rigorous way during pre-market risk assessment. Risk managers should acknowledge the limits of environmental monitoring programmes as a tool for decision-making.

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

    Science.gov (United States)

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

    2012-01-01

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

  7. Safety and Effectiveness of Natalizumab: First Report of Interim Results of Post-Marketing Surveillance in Japan.

    Science.gov (United States)

    Saida, Takahiko; Yokoyama, Kazumasa; Sato, Ryusuke; Makioka, Haruki; Iizuka, Yukihiko; Hase, Masakazu; Ling, Yan; Torii, Shinichi

    2017-12-01

    Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillance of natalizumab-treated MS patients from Japan to investigate the safety and effectiveness of natalizumab in a real-world clinical setting in Japan. Here, we report the results of an interim analysis. During the observation period of 2 years, all patients who were treated with natalizumab subsequent to its approval in Japan were followed. The effectiveness of natalizumab was assessed by examining the changes in expanded disability status scale (EDSS) score and annualized relapse rate (ARR) from baseline. Safety was assessed by analyzing the incidence of adverse drug reactions (ADRs). The safety analysis included 106 patients (mean age 39.3 years; women 62.3%) whose data were collected until the data lock point (February 7, 2016). The effectiveness analysis included 75 patients. The majority of patients had relapsing-remitting MS (93/106 patients; 87.7%). The mean length of treatment exposure in the present study was 6.6 months. During the 2-year observation period, no significant change in the EDSS was observed, while the ARR decreased significantly from baseline (72.9% reduction, p = 0.001). ADRs and serious ADRs were observed in 11.3% and 3.8% of patients, respectively; however, no new safety concerns were detected. No patient had progressive multifocal leukoencephalopathy (PML) during the present study period. The safety and effectiveness of natalizumab were confirmed in Japanese patients with MS in clinical practice. Nevertheless, potential risks including PML require continuous, careful observation. Biogen Japan Ltd (Tokyo, Japan).

  8. Post-marketing surveillance of quinolones 1988-1990.

    Science.gov (United States)

    Davey, P G; McDonald, T; Lindsay, G

    1991-04-01

    It has been much easier to obtain original data on adverse drug reactions (ADR) of quinolones from the pharmaceutical industry than it was two years ago. This is to be welcomed and, as anticipated, the new data continue to suggest that the new 4-quinolones have an ADR profile which is very similar to that of other antimicrobials. Visual disturbance is not a prominent feature, in contrast to the ADR profile of nalidixic acid. Better definition of quinolone ADRs requires prospective study, and the results of a newly completed prescription event monitoring study are awaited with interest. The potential use of computerised databases and record linkage is examined, but at present the number of quinolone prescriptions is too small to assess documentation of serious but rare events such as convulsions. Physicians need to be aware of the limitations of current data on suspected ADRs. Further investment in computerised databases is required to satisfy the requirements for attributing causality of an event to a drug.

  9. Study on the Pollution-heaven Hypothesis Focusing on Pollution-Intensive Industries

    Energy Technology Data Exchange (ETDEWEB)

    Lho, S.W. [Kyungnam University, Masan (Korea)

    2002-03-01

    The purpose of this study is to test pollution-heaven hypothesis on the Korean pollution-intensive industries, that is, textile and clothing, petrochemical and primary metal industry. The empirical study examines that foreign direct investment(FDI) of Korean pollution-intensive industries regresses on couple of exogenous variables and the environmental regulation on FDI. As the environmental regulation is not directly observed, it uses C0{sub 2} emissions as the pollutant. The results of the study show that the environmental regulation in a host country is an insignificant determinant of FDI for the Korean polluting industries. That is, they do not support Leonard (1988), Xing and Kolstad (2000) that the hypothesis is a significant for heavily polluting industries. (author). 34 refs., 10 tabs.

  10. Safety and Antihypertensive Effect of Selara® (Eplerenone: Results from a Postmarketing Surveillance in Japan

    Directory of Open Access Journals (Sweden)

    Shoko Takahashi

    2016-01-01

    Full Text Available Prospective postmarketing surveillance of Selara (eplerenone, a selective mineralocorticoid receptor antagonist, was performed to confirm its safety and efficacy for hypertension treatment in Japan. The change in blood pressure after initiation of eplerenone treatment was also examined. Patients with essential hypertension who were eplerenone-naïve were recruited regardless of the use of other antihypertensive drugs. For examination of changes in blood pressure, patients were excluded if eplerenone was contraindicated or used off-label. Patients received 50–100 mg of eplerenone once daily and were observed for 12 weeks. No treatments including antihypertensive drugs were restricted during the surveillance period. Across Japan, 3,166 patients were included for safety analysis. The incidence of adverse drug reactions was 2.4%. The major adverse drug reactions observed were hyperkalemia (0.6%, dizziness, renal impairment, and increased serum potassium (0.2% each. The mean systolic blood pressure decreased from 152.1±19.0 mmHg to 134.8±15.2 mmHg at week 12, and the mean diastolic blood pressure decreased from 85.8±13.7 mmHg to 77.7±11.4 mmHg. There were no significant new findings regarding the type or incidence of adverse reactions, and eplerenone had a clinically significant antihypertensive effect, leading to favorable blood pressure control.

  11. Carbon reduction potentials of China's industrial parks: A case study of Suzhou Industry Park

    International Nuclear Information System (INIS)

    Wang, Hongsheng; Lei, Yue; Wang, Haikun; Liu, Miaomiao; Yang, Jie; Bi, Jun

    2013-01-01

    Industrial parks are the economic engines for many China regions, but they also consume a great deal of energy and emit greenhouse gases. However, few empirical studies have examined these special communities. We selected SIP (Suzhou Industrial Park) as a case study. Carbon emissions from SIP were accounted from the consumption perspective to analyze their characteristics. Results showed total carbon emissions grew 85.2% from 2005 to 2010, and carbon intensity (carbon emissions per unit of GDP (gross domestic product)) decreased by 9%. Scenario analysis was then used to depict emissions trajectories under three different pathways. The total carbon emissions and per capita carbon emissions for SIP will undoubtedly increase in the near future under a business-as-usual scenario, improved-policy scenario, and low-carbon scenario; the carbon intensity will decrease by 38% under low-carbon scenario, but it will still be difficult to reach the national mitigation target. In addition, geographic-boundary-based accounting methodology was applied for comparison analysis, carbon emissions show a large gap of 42.4–65.1% from 2005 to 2010, due to failure to account for cross-boundary emissions from imported electricity. Therefore, comprehensive analysis from a consumption perspective is necessary to provide a fair and comprehensive tool for China's local decision-makers to evaluate carbon mitigation potentials. - Highlights: ► Carbon reduction potentials of industrial parks, which are important communities in China, were analyzed. ► Comprehensive carbon emission inventories were developed for a China's industrial park. ► Policies were recommended for industrial parks to achieve low-carbon development target. ► Consumption-based emission inventory is necessary for local government to evaluate carbon reduction potentials

  12. A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran.

    Science.gov (United States)

    Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Ebadifard Azar, Farbod; Nabilo, Bahram; Abolghasem Gorji, Hassan; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh

    2015-04-23

    Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world's greatest businesses. The aim of this study was to analyze Iran's comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran's trade in this field. To identify Iran's comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran's intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran's Customs Administration, Iran's pharmaceutical Statistics, World Bank and International Trade Center. The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world's total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran's pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran's intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade.

  13. Study on the Application of PSA Method on Non-Nuclear Industry Facilities

    International Nuclear Information System (INIS)

    Andi Sofrany E; Anhar R Antariksawan; Sony T, D.T.; Puradwi IW; Sugiyanto; Giarno

    2003-01-01

    A preliminary study related to utilization of probabilistic method in non-nuclear industry facilities has been conducted The study has been performed by examining literature studies and results of research paper related to the topic. The objective of this study is to know how far the method, which is a standard in the nuclear industry, is applied in the non-nuclear fields. The PSA application in the non-nuclear process industry is mainly performed as risk management. The concept of risk management enables a systematic and realistic framework to be established for accident prevention as a whole process of hazard identification, risk estimation, risk evaluation, control measures establishment, its implementation. The most important part of this study is indeed the hazard identification and risk estimation in order to assess the consequences and to estimate event probability. The risk assessment methodology, which is also used in the probabilistic assessment of nuclear and non-nuclear industry, is performed both quantitatively and qualitatively approached by several technique analysis. Based on literature and research paper study, there are 3 main technique analysis, which can be applied in the risk management of non-nuclear industry, which are fault tree analysis (FTA), event tree analysis (ETA), and Hazard and Operability Studies (HAZOPS). The potential hazard arise in the non-nuclear process industry are flammability hazard; toxicity hazard; reactivity hazard; and elevated pressure hazard The fault tree analysis has been practically applied in the petroleum industry, chemical industry, and also other industry for improvement of safety installation by modification in the installation design or operation procedures. The event tree analysis has been applied only limited in the chemical process industry or other process industry. On the other application, HAZOPS technique can be combined with the event tree analysis with approach of accident scenario identification

  14. Manufacturing Industry, Industry Study, Spring 2009

    Science.gov (United States)

    2009-01-01

    Shuib, Lieutenant Colonel, Royal Malaysian Air Force Kevin Brennan, Commander, U.S. Navy Mr. K. Ilia Christman, Department of the Navy Robert Costa...panel to review the impact of taxation , regulatory compliance, and benefits burdens on domestic manufacturers. Review would bring focus to ways...Finally, the MISG considered the effect of these 14 characteristics on the U.S. Manufacturing Industry vis-à-vis Chinese and Malaysian

  15. Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective.

    Science.gov (United States)

    Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

    2017-06-01

    The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers.

  16. Non-auditory effects of noise in industry. VI. A final field study in industry

    NARCIS (Netherlands)

    van Dijk, F. J.; Souman, A. M.; de Vries, F. F.

    1987-01-01

    Non-auditory effects of noise were studied among 539 male workers from seven industries. The LAeq, assessed by personal noise dosimetry, has been used to study acute effects. Various indices of total noise exposure, involving level and duration, were developed for long-term effect studies. In the

  17. Self-evaluation System for Low carbon Industrial Park--A Case Study of TEDA Industrial Park in Tianjin

    Science.gov (United States)

    Wenyan, W.; Fanghua, H.; Ying, C.; Ouyang, W.; Yuan, Q.

    2013-12-01

    Massive fossil fuel burning caused by industrialization development is one major reason of global climate change. After Copenhagen climate summit, the studies of low-carbon city gain attentions from many countries. On 25th Nov. 2009, the State Council executive meeting announced that by 2020 China will reduce the carbon dioxide emissions per unit of GDP by 40% to 45% compared with the level of 2005. Industrial Park as an important part of city, has developed rapidly in recent years, and turns into a key element and an alternative mechanism to achieve emission reduction target. Thus, establishing a low carbon development model for industrial park is one of the most effective ways to build sustainable low carbon cities. By adopting the self-evaluation system of low carbon industrial park, this research aims to summarize the low carbon concept in industrial park practice. According to The Guide for Low Carbon Industrial Development Zones, the quantitative evaluation system is divided into 4 separate categories with 23 different quantitative indicators. The 4 categories include: 1) energy and GHG management (weigh 60%), 2) circular economy and environmental protection (weigh 15%), 3) administration and incentive mechanisms of industrial parks (weigh 15%), and 4) planning and urban forms (weigh 10%). By going through the necessary stages and by leading continuous improvements low carbon development goals can be achieved. Tianjin TEDA industrial park is selected as one case study to conduct an assessment on TEDA low-carbon development condition. Tianjin TEDA Industrial Park is already an ecological demonstration industrial park in China, with good foundations on environmental protection, resource recycling, etc. Based on the self-evaluation system, the indicators, such as the energy using efficiency and the degree of land intensive utilization, are also analyzed and assessed. Through field survey and data collection, in accordance with the quantitative self

  18. quality evaluation of paracetamol in the bulk, dosage forms

    African Journals Online (AJOL)

    Prince Acheampong

    assay of paracetamol-codeine combination drug as well as estimation of the amount of ... post-market is very essential in the policy and technical guidelines of drug regulatory authorities such as the Food and Drugs Board. ... Pharmaceutical industries may also have simple analytical procedures for both in-process and.

  19. A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran

    Science.gov (United States)

    Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Azar, Farbod Ebadifard; Nabilo, Bahram; Gorji, Hassan Abolghasem; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh

    2015-01-01

    Background: Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world’s greatest businesses. The aim of this study was to analyze Iran’s comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran’s trade in this field. Methods: To identify Iran’s comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran’s intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran’s Customs Administration, Iran’s pharmaceutical Statistics, World Bank and International Trade Center. Results: The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world’s total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran’s pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran’s intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. Conclusions: The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade. PMID:26153184

  20. Characterization study of industrial waste glass as starting material ...

    African Journals Online (AJOL)

    In present study, an industrial waste glass was characterized and the potential to assess as starting material in development of bioactive materials was investigated. A waste glass collected from the two different glass industry was grounded to fine powder. The samples were characterized using X-ray fluorescence (XRF), ...

  1. KEUNGGULAN KOMPETITIF INDUSTRI KECIL DI KLASTER INDUSTRI KECIL TRADISIONAL DENGAN PENDEKATAN BERBASIS SUMBER DAYA: STUDI KASUS PENGUSAHA INDUSTRI KECIL LOGAM KIARA CONDONG, BANDUNG

    Directory of Open Access Journals (Sweden)

    Widjajani Widjajani

    2008-01-01

    Full Text Available Small-scale industries play an important role in the betterment of society. Industrial cluster approach has been used by government as an alternative government policy to increase competitiveness of small-scale industries in Indonesia. An industry cluster consists of core enterprise(s and related enterprises in which the core acts as a pulling agent for the other counterparts. Therefore, developing the core enterprises is expected to increase competitiveness of the whole cluster. This research is a strategy process research, aiming at identifying and modeling strategic behavior of a successful entrepreneur in a metal-making cluster industry at Kiara Condong Bandung, West Java. Based on the literature review, qualitative research methodology is used in this research by combining soft systems methodology (SSM and grounded theory. The major findings of this research indicate four kinds of strategic behavior models, namely behavior model of strategy setting, behavior model of production operations, behavior model of research and development and innovation and behavior model of marketing operations. Abstract in Bahasa Indonesia: Industri kecil mempunyai peranan penting dalam meningkatkan kesejahteraan masyarakat. Pendekatan klaster industri dicanangkan oleh pemerintah sebagai alternatif kebijakan pemerintah untuk membangun keunggulan kompetitif di industri kecil. Di suatu klaster industri kecil yang terdiri dari unit usaha inti dan unit usaha penunjang, unit usaha inti merupakan gerbong penghela klaster. Oleh karena itu mengembangkan usaha inti sehingga mempunyai keunggulan kompetitif diharapkan dapat mengembangkan klaster secara keseluruhan. Penelitian ini merupakan penelitian proses strategi (strategy process research yang meneliti perilaku strategis manajer pemilik industri kecil dalam mengelola usahanya untuk membangun keunggulan kompetitif dengan pendekatan berbasis sumber daya (Resource-Based View atau RBV dan mengambil studi kasus pengusaha

  2. Industrial and agricultural process heat information user study

    Energy Technology Data Exchange (ETDEWEB)

    Belew, W.W.; Wood, B.L.; Marle, T.L.; Reinhardt, C.L.

    1981-03-01

    The results of a series of telephone interviews with groups of users of information on solar industrial and agricultural process heat (IAPH) are described. These results, part of a larger study on many different solar technologies, identify types of information each group needed and the best ways to get information to each group. In the current study only high-priority groups were examined. Results from 10 IAPH groups of respondents are analyzed in this report: IPH Researchers; APH Researchers; Representatives of Manufacturers of Concentrating and Nonconcentrating Collectors; Plant, Industrial, and Agricultural Engineers; Educators; Representatives of State Agricultural Offices; and County Extension Agents.

  3. Safety of telmisartan in patients with arterial hypertension - An open-label observational study

    NARCIS (Netherlands)

    Michel, Martin C.; Bohner, Herbert; Köster, Jürgen; Schäfers, Rafael; Heemann, Uwe

    2004-01-01

    Objective: To determine whether age, gender, concomitant disease and/or previous or present antihypertensive medication affect the safety or antihypertensive efficacy of telmisartan in the treatment of arterial hypertension. Study Design and Methods: In this large-scale, open-label postmarketing

  4. Premarket safety and efficacy studies for ADHD medications in children.

    Directory of Open Access Journals (Sweden)

    Florence T Bourgeois

    Full Text Available Attention-deficit hyperactivity disorder (ADHD is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing.We identified all ADHD medications approved by the Food and Drug Administration (FDA and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug's clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials.A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419. Eleven drugs (55% were approved after <100 participants were studied and 14 (70% after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9, with 5 (38% drugs approved after participants were studied <4 weeks and 10 (77% after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed.Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved.

  5. Study rates U.S. hospitals vs. other nations, industries.

    Science.gov (United States)

    Burda, D

    1991-10-07

    American hospitals generally are further along with their total quality management programs than their Canadian counterparts but lag behind companies in other U.S. industries, according to a comprehensive international study that examined four industries--healthcare, automotive, banking and computer--in four countries--the United States, Canada, Germany and Japan.

  6. Comparative studies of utilization of industrial electron accelerators and adsorption with activated carbon for industrial effluent treatment

    International Nuclear Information System (INIS)

    Sampa, Maria Helena de O.; Rela, Paulo R.; Duarte, Celina Lopes; Las Casas, Alexandre; Mori, Manoel Nunes; Omi, Nelson M.

    2005-01-01

    A technical and economical feasibility study was performed comparing the use electron beam and activated charcoal for treatment of industrial wastewater. In this study was used synthetic solutions, prepared in laboratory with organic compounds standards, where the composition was focused on the critical organic contaminants usually presented in wastewater from petrochemical industry. For the sample irradiation was used an industrial electron beam from Radiation Dynamics Inc. 1.5 MeV - 37.5 kW setup in IPEN. The doses ranged from 5 kGy to 100 kGy. A common granulated activated charcoal in a fixed-bed absorber glass column was used to study the pollutants absorption performance. The results show that if the adequate irradiation dose was delivered to the organic pollutant, it is possible to conclude for the studied compounds that the Electron Beam Process is, in aspect of organic removal efficiency, similar to the activated carbon process. (author)

  7. Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review.

    Science.gov (United States)

    Polisena, Julie; Forster, Alan J; Cimon, Karen; Rabb, Danielle

    2013-10-10

    Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature. This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting. Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.

  8. 77 FR 7166 - Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late...

    Science.gov (United States)

    2012-02-10

    ... late in the development of a drug for marketing approval or after approval based on what is already... investigational drugs to support marketing approval (premarket) and trials conducted after approval (postmarket... assessment without compromising the integrity of the trial results. DATES: Although you can comment on any...

  9. Industry-identified combustion research needs: Special study

    Energy Technology Data Exchange (ETDEWEB)

    Keller, J.G.; Soelberg, N.R.; Kessinger, G.F.

    1995-11-01

    This report discusses the development and demonstration of innovative combustion technologies that improve energy conservation and environmental practices in the US industrial sector. The report includes recommendations by industry on R&D needed to resolve current combustion-related problems. Both fundamental and applied R&D needs are presented. The report assesses combustion needs and suggests research ideas for seven major industries, which consume about 78% of all energy used by industry. Included are the glass, pulp and paper, refinery, steel, metal casting, chemicals, and aluminum industries. Information has been collected from manufacturers, industrial operators, trade organizations, and various funding organizations and has been supplemented with expertise at the Idaho National Engineering Laboratory to develop a list of suggested research and development needed for each of the seven industries.

  10. Possibility of Database Research as a Means of Pharmacovigilance in Japan Based on a Comparison with Sertraline Postmarketing Surveillance.

    Science.gov (United States)

    Hirano, Yoko; Asami, Yuko; Kuribayashi, Kazuhiko; Kitazaki, Shigeru; Yamamoto, Yuji; Fujimoto, Yoko

    2018-05-01

    Many pharmacoepidemiologic studies using large-scale databases have recently been utilized to evaluate the safety and effectiveness of drugs in Western countries. In Japan, however, conventional methodology has been applied to postmarketing surveillance (PMS) to collect safety and effectiveness information on new drugs to meet regulatory requirements. Conventional PMS entails enormous costs and resources despite being an uncontrolled observational study method. This study is aimed at examining the possibility of database research as a more efficient pharmacovigilance approach by comparing a health care claims database and PMS with regard to the characteristics and safety profiles of sertraline-prescribed patients. The characteristics of sertraline-prescribed patients recorded in a large-scale Japanese health insurance claims database developed by MinaCare Co. Ltd. were scanned and compared with the PMS results. We also explored the possibility of detecting signals indicative of adverse reactions based on the claims database by using sequence symmetry analysis. Diabetes mellitus, hyperlipidemia, and hyperthyroidism served as exploratory events, and their detection criteria for the claims database were reported by the Pharmaceuticals and Medical Devices Agency in Japan. Most of the characteristics of sertraline-prescribed patients in the claims database did not differ markedly from those in the PMS. There was no tendency for higher risks of the exploratory events after exposure to sertraline, and this was consistent with sertraline's known safety profile. Our results support the concept of using database research as a cost-effective pharmacovigilance tool that is free of selection bias . Further investigation using database research is required to confirm our preliminary observations. Copyright © 2018. Published by Elsevier Inc.

  11. Supplier quality assurance systems: a study in the nuclear industry

    International Nuclear Information System (INIS)

    Singer, A.J.; Churchill, G.F.; Dale, B.G.

    1988-01-01

    The results are reported of a study which investigated the impact of quality assurance on 13 suppliers to the nuclear industry. The purpose of the study was to determine the benefits and problems of applying quality assurance in the supply of high risk plant items and material for nuclear installations. The paper discusses the problems facing the industry including: multiple audits and inspections, the irritation with having to contend with two quality system standards (namely BS 5750 and BS 5882) and the cost effectiveness of the more stringent quality system and quality control surveillance requirements imposed by the nuclear industry. It is also pointed out that companies supplying non-nuclear industrial customers were dissatisfied with the qualifications, experience and professional competence of some auditors and many inspectors. (author)

  12. Coping with Power Interruptions in Tanzania: An Industrial Perspective A Case Study of One Small Scale Animal Food Processing Industry in Moshi Municipality

    OpenAIRE

    Kavishe, Theodora Ephrem

    2015-01-01

    This study was conducted in Moshi-Tanzania. The research topic is Coping with Power Interruptions in Tanzania.An Industrial Perspesctive:A Case Study of one Small Scale Animal Food Processing Industry in Moshi Municipality.The objectives are (1) to explore perceptions of staff in the industry and among TANESCO towards interruptions in power supply (2) to describe the coping strategies developed by the industry under study. The study was guided by Resource Dependence Theory (RDT) by Pfeffer an...

  13. Industrial Pollution in Ghana: Some Selected Case Studies of Industries in Tema

    International Nuclear Information System (INIS)

    Taylor, Nora Priscilla Ama Kuma

    1999-09-01

    Waste waters from eight selected industries namely Tema Oil Refinery, Tuyee Manufacturing Industries, Cocoa Processing Company, Tema Lube Oil Company Limited, Pioneer Food Cannery Limited, Bridal Trust Paints Company Limited, Ghana Textiles Manufacturing Company and Ghana Textiles Printing Company Limited were sampled and subjected to various physico-chemical and trace metal analysis to determine levels of pollutants, using standard methods of WHO, AO AC and APHA. Generally, the ROD values were found to be high for all the industries. Some other parameter levels were significantly high enough for the individual industries to deserve attention. Generally, the results seem to suggest that these industries sited in Tema, are likely contributors to the high degree of pollution of the Chemu and Gao Lagoons which have been reported by various workers as being highly polluted. Consequent to the results obtained, an attempt was made to treat the wastewaters. Thus wastewaters of three of these major industries Ghana Textiles Manufacturing Company. Pioneer Food Cannery Company Limited and Tema Lube Oil Company Limited, representing the textile, food and petroleum-based industries in the Tema industrial area of Ghana were subjected to various physical and chemical treatments using mainly local materials, to try and reduce the levels of pollutants detected in the earlier investigations. Sedimentation, filtration using paper and sea-sand and adsorption using charcoals prepared from dried coconut husks and palm kernel husks as well as industrially prepared activated charcoal as adsorbents, were some of the physical methods used whilst chemical precipitation and oxidation-reduction were the chemical methods used to bring about the desired results. Six different naturally occurring soil samples from Ankaful, Ekon and Elmina in the Central Region, Asokwa in the Ashanti Region, Bokazo in the Western Region and Somanya in the Eastern Region were also used to obtain some levels of

  14. Understanding transferable supply chain lessons and practices to a "high-tech" industry using guidelines from a primary sector industry: a case study in the food industry supply chain.

    Science.gov (United States)

    Coronado Mondragon, Adrian E; Coronado Mondragon, Christian E; Coronado, Etienne S

    2015-01-01

    Flexibility and innovation at creating shapes, adapting processes, and modifying materials characterize composites materials, a "high-tech" industry. However, the absence of standard manufacturing processes and the selection of materials with defined properties hinder the configuration of the composites materials supply chain. An interesting alternative for a "high-tech" industry such as composite materials would be to review supply chain lessons and practices in "low-tech" industries such as food. The main motivation of this study is to identify lessons and practices that comprise innovations in the supply chain of a firm in a perceived "low-tech" industry that can be used to provide guidelines in the design of the supply chain of a "high-tech" industry, in this case composite materials. This work uses the case study/site visit with analogy methodology to collect data from a Spanish leading producer of fresh fruit juice which is sold in major European markets and makes use of a cold chain. The study highlights supply base management and visibility/traceability as two elements of the supply chain in a "low-tech" industry that can provide guidelines that can be used in the configuration of the supply chain of the composite materials industry.

  15. Electricity distribution industry restructuring in South Africa: A case study

    International Nuclear Information System (INIS)

    Gaunt, C.T.

    2008-01-01

    For 20 years there has been vigorous debate about restructuring the large, developed electricity industry in South Africa, but the plans have not been implemented. The justification of the proposed restructuring illustrates the different expectations of the participants in the electricity industry. The case study reviews what has occurred against a background of some theories about organisations, and identifies six key issues. Some lessons include the need to adopt an industry structure compatible with the objectives of electricity distribution in developing countries, the unsuitability of orthodox approaches to organisations, that no industry structure appears to be significantly better than others, industry restructuring of public sector utilities has a significant political dimension, restructuring can fail even if there is support from a high level of government, and indecision and uncertainty have serious negative consequences. The experience should be helpful for other developing countries considering structural change of their electricity industry

  16. Environmental and Socio-economic Aspects of the Operation of Industrial Regions: The Case Study of the Industrial Area of Alexandroupolis (Greece)

    International Nuclear Information System (INIS)

    Theofanoudi, Aglaia; Diakaki, Christina; Katsivela, Eleftheria

    2009-01-01

    The paper summarizes the results of a study concerning the operation of industrial plants and their effects to the environment. It also addresses, shortly, the consequences to the quality of human life and proposes potential measures that may contribute to the reduction of the negative environmental impacts. The relatively small organized Industrial Area of Alexandroupolis (Greece) is examined as a case study. In particular, the activities of its major industrial facilities are presented and their emissions to the environment are examined. In addition, the socio-economic aspects of the operation of the Industrial Area are studied. The results of the study showed that the operation of the Industrial Area has specific negative effects in the natural environment of the region and in the quality of life of the residents. Methodological and legislative tools, such as control systems for the environmental pollution, the green chemistry, and the environmental management systems, may be employed to assist the prevention and confrontation of environmental problems

  17. 76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505...

    Science.gov (United States)

    2011-04-01

    ... and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51...

  18. Supply chain co-ordination and industry clockspeed: an exploratory study

    NARCIS (Netherlands)

    Voordijk, Johannes T.; Akkermans, Henk; Meijboom, Bert

    2003-01-01

    The increasing velocity of change, or clockspeed, in the business environment is a key challenge for firms and industries nowadays. In this study, the impact of industry and organisation clockspeed on specific mechanisms used for supply chain co-ordination is investigated from an

  19. MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population.

    Science.gov (United States)

    Di Biase, Luigi; Tung, Roderick; Szili-Torok, Tamás; Burkhardt, J David; Weiss, Peter; Tavernier, Rene; Berman, Adam E; Wissner, Erik; Spear, William; Chen, Xu; Neužil, Petr; Skoda, Jan; Lakkireddy, Dhanunjaya; Schwagten, Bruno; Lock, Ken; Natale, Andrea

    2017-04-01

    Patients with ischemic cardiomyopathy (ICM) are prone to scar-related ventricular tachycardia (VT). The success of VT ablation depends on accurate arrhythmogenic substrate localization, followed by optimal delivery of energy provided by constant electrode-tissue contact. Current manual and remote magnetic navigation (RMN)-guided ablation strategies aim to identify a reentry circuit and to target a critical isthmus through activation and entrainment mapping during ongoing tachycardia. The MAGNETIC VT trial will assess if VT ablation using the Niobe™ ES magnetic navigation system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT and low ejection fraction. This is a randomized, single-blind, prospective, multicenter post-market study. A total of 386 subjects (193 per group) will be enrolled and randomized 1:1 between treatment with the Niobe ES system and treatment via a manual procedure at up to 20 sites. The study population will consist of patients with ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of ≤35% and implantable cardioverter defibrillator (ICD) who have sustained monomorphic VT. The primary study endpoint is freedom from any recurrence of VT through 12 months. The secondary endpoints are acute success; freedom from any VT at 1 year in a large-scar subpopulation; procedure-related major adverse events; and mortality rate through 12-month follow-up. Follow-up will consist of visits at 3, 6, 9, and 12 months, all of which will include ICD interrogation. The MAGNETIC VT trial will help determine whether substrate-based ablation of VT with RMN has clinical advantages over manual catheter manipulation. Clinicaltrials.gov identifier: NCT02637947.

  20. Studies of necessity and opportunity in the field of industrial risk

    International Nuclear Information System (INIS)

    Stefanescu, I.; Cristescu, I.

    1995-01-01

    This paper presents a study of necessity and opportunity of risk analyses in industrial installations with potential dangerous activity. The input data for this study were provided from a large number of industrial units all over the country. The obtained results point to the importance of such studies especially in case of nuclear facilities

  1. Clinical significance and epidemiologic analyses of Mycobacterium avium and Mycobacterium intracellulare lung disease from post-marketing surveillance.

    Science.gov (United States)

    Suzuki, Katsuhiro; Kurashima, Atsuyuki; Tatsuno, Kinji; Kadota, Jun-Ichi

    2018-01-01

    In Japan, nontuberculous mycobacterial lung disease is mostly attributable to Mycobacterium avium complex (MAC), i.e., M. avium or M. intracellulare. However, clinical features of the disease caused by these two pathogens have not been studied sufficiently yet. A post-marketing survey of clarithromycin was performed at 130 facilities across Japan. The data on patients with M. avium infection and patients with M. intracellulare infection were selected from this survey for comparison of background variables and clinical features of the two pathogens. Among the patients analyzed (n = 368), 67.4% had M. avium infection and 32.6% had M. intracellulare infection. Stratified analysis revealed no significant differences between the ratio of the two pathogens based on gender, disease type, complication, past medical history, or smoking history. However, the percentage of patients with M. intracellulare infection was significantly higher among those with underlying lung disease than among those without lung disease (p = 0.0217). The percentage of patients with M. intracellulare infection rose significantly with age (p = 0.0296). This age-related change was more significant in women (p = 0.0018). When district-wise analysis was performed for Japan, the percentage of M. intracellulare infection was higher in the Chugoku/Shikoku and Kyushu districts whereas the percentage of M. avium infection was higher in the other districts. This survey revealed some differences in the clinical and epidemiologic features of M. avium and M. intracellulare infection. The significant predominance of M. avium infection among relatively young women is suggestive of an increase in the M. avium/M. intracellulare infection ratio among women in the future. Copyright © 2017 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

  2. Industrial College of the Armed Forces Industry Studies 2003

    National Research Council Canada - National Science Library

    Austin, Stephen

    2003-01-01

    .... Two growth niches are military privatization initiatives and security enhancements. While devoting more resources to information technology, full realization of the benefits still exceed industry's grasp...

  3. Understanding Transferable Supply Chain Lessons and Practices to a “High-Tech” Industry Using Guidelines from a Primary Sector Industry: A Case Study in the Food Industry Supply Chain

    Science.gov (United States)

    Coronado Mondragon, Adrian E.; Coronado, Etienne S.

    2015-01-01

    Flexibility and innovation at creating shapes, adapting processes, and modifying materials characterize composites materials, a “high-tech” industry. However, the absence of standard manufacturing processes and the selection of materials with defined properties hinder the configuration of the composites materials supply chain. An interesting alternative for a “high-tech” industry such as composite materials would be to review supply chain lessons and practices in “low-tech” industries such as food. The main motivation of this study is to identify lessons and practices that comprise innovations in the supply chain of a firm in a perceived “low-tech” industry that can be used to provide guidelines in the design of the supply chain of a “high-tech” industry, in this case composite materials. This work uses the case study/site visit with analogy methodology to collect data from a Spanish leading producer of fresh fruit juice which is sold in major European markets and makes use of a cold chain. The study highlights supply base management and visibility/traceability as two elements of the supply chain in a “low-tech” industry that can provide guidelines that can be used in the configuration of the supply chain of the composite materials industry. PMID:25821848

  4. 2001 Industry Studies: Land Combat Systems

    Science.gov (United States)

    2001-01-01

    invest in human capital, to allocate resources to R&D, to take advantage of information technology , to expand their markets beyond traditional...their efforts to broaden their markets and services. This means greater efforts to exploit information technology in order to control worldwide...three essays of foremost importance to the industry supplement the study’s depth and utility: the US Army’s transformation, information technology

  5. Shipbuilding Industry Study 2004

    National Research Council Canada - National Science Library

    Montroll, Mark; Johnson, Keith; Chandler, Brett; Wood, Robert; Hale, Timothy; Nally, Kevin; Harmand, Patrick; Danielescu, Marius; McQueen, Rick; Larese, William S

    2004-01-01

    ...-going military vessels. As capable as the U.S. shipbuilding industry is in responding to the world's most demanding National Security Strategy, the same cannot be said in the global commercial marketplace...

  6. Siting study for small platform-mounted industrial energy reactors

    International Nuclear Information System (INIS)

    1975-07-01

    Utilizing an existing 313 MW(t) ship propulsion reactor design, a concept has been formulated for a floating platform-mounted nuclear plant and an evaluation has been made to determine reductions in construction time and cost achievable by repetitive platform construction in a shipyard. Concepts and estimates are presented for siting platform-mounted nuclear plants at the location of industrial facilities where the nuclear plants would furnish industrial process heat and/or electrical power. The representative industrial site designated for this study is considered typical of sites that might be used along the extensive network of navigable canals adjacent to the ocean and is similar to potential sites along the inland waterways of the United States

  7. Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis.

    Science.gov (United States)

    Takeuchi, Tsutomu; Kawai, Shinichi; Yamamoto, Kazuhiko; Harigai, Masayoshi; Ishida, Kota; Miyasaka, Nobuyuki

    2014-01-01

    A post-marketing surveillance (PMS) program was implemented to assess the safety and effectiveness of tacrolimus (TAC) in Japanese rheumatoid arthritis (RA) patients and to identify risk factors related to adverse drug reactions (ADRs). Patients were registered centrally and monitored for all adverse events (AEs) for 24 weeks. Effectiveness was evaluated using the Disease Activity Score 28-CRP (DAS28-CRP). Data from 3,172 patients (mean age 62.2 years) were evaluated in the safety analysis. Of the safety population, 78.5 %were female and 25.9 % were in Steinbrocker's functional class 3 or 4. TAC was prescribed as monotherapy in 52.5 % and the most common concomitant disease modifying antirheumatic drug (DMARD) was methotrexate, used in 28.9 % of the patients. The incidence of AEs, serious AEs (SAEs), ADRs and serious ADRs were 41.2, 6.4, 36.0, and 4.9 %, respectively. The most frequent serious ADR category was infections and infestations. Age ≥ 65 years, concurrent renal dysfunction, and concurrent diabetes mellitus were identified as significant risk factors for ADR. Based on EULAR response criteria, 65.4 % of the patients showed moderate or good response. The results demonstrate that TAC is well tolerated by Japanese patients with active RA, including those receiving concomitant methotrexate, in the real world.

  8. Entrepreneurship in the Fashion Industry : A Case Study of Slow Fashion Businesses

    NARCIS (Netherlands)

    T. Brydges (Taylor); M. Lavanga (Mariangela); L. von Gunten (Lucia)

    2014-01-01

    markdownabstractIn this chapter, we explore entrepreneurship in the slow fashion industry at a time of significant restructuring in the global fashion industry. Drawing on a case study of selfemployed designers in the slow fashion industry in Geneva (Switzerland), Rotterdam (The Netherlands) and

  9. 77 FR 13612 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-07

    ... plague (plague infection with extensive lung involvement) in African Green Monkeys and provide advice.... Safety and other supportive information is derived from clinical studies and post-marketing experience in... studies and post-marketing experience in humans. FDA intends to make background material available to the...

  10. Study of skin and mucous membrane disorders among workers engaged in the sodium dichromate manufacturing industry and chrome plating industry.

    Science.gov (United States)

    Singhal, Vijay Kumar; Deswal, Balbir Singh; Singh, Bachu Narayan

    2015-01-01

    Inhalation of dusts and fumes arising during the manufacture of sodium dichromate from chrome ore, chromic acid mist emitted during electroplating, and skin contact with chromate produce hazards to workers. (1) To elucidate the prevalence of skin and mucous membrane disorders among the workers engaged in the sodium dichromate manufacturing industry and chrome plating industry. (2) To know the relationship of prevalence with the duration of exposure to chrome mist, dust, and fumes. A cross-sectional study was conducted among all the workers engaged in sodium dichromate manufacturing and chrome plating from several industries situated near the Delhi-Haryana border in the districts of Faridabad and Sonepat of Haryana, India from January 01, 2014 to December 31, 2014. All the workers available from the concerned industries for the study were interviewed and medically examined after obtaining their informed consent. A total of 130 workers comprising 66 workers from the sodium dichromate manufacturing industry and 64 workers from the chrome plating industry were examined on a pretested schedule. Descriptive statistical methods (proportions, relative risk, and Chi-square test of significance with P value analyzed using Epi Info version 7). All the workers were found to be males and of the adult age group. Out of the total examined, 69.69% and 56.22% of the workers had disorders of the nasal mucous membrane in the sodium dichromate manufacturing industry and the chrome plating industry, respectively. 42.42% and 28.22% of the workers had perforation of the nasal septum in the sodium dichromate manufacturing industry and chrome plating industry, respectively. 6.06% and 3.12% workers had skin ulcers in the sodium dichromate manufacturing industry and chrome plating industry, respectively. Nasal irritation and rhinorrhea were the most commonly found symptoms in both the processes. 48.48% and 90.52% of the workers were using hand gloves in the sodium dichromate manufacturing

  11. Safety and effectiveness of certolizumab pegol in patients with rheumatoid arthritis: Interim analysis of post-marketing surveillance.

    Science.gov (United States)

    Kameda, Hideto; Nishida, Keiichiro; Nannki, Toshihiro; Watanabe, Akira; Oshima, Yukiya; Momohara, Shigaki

    2017-01-01

    Objective: To evaluate the safety and effectiveness of certolizumab pegol (CZP) in a real-world setting among Japanese patients with rheumatoid arthritis. Post-marketing surveillance data from 2,579 patients treated with CZP were analyzed. Adverse events (AEs) observed during the 24-week CZP treatment period were recorded. Disease activity was evaluated using DAS28-ESR and DAS28-CRP at baseline, Week 12, Week 24, or at withdrawal. The total period of exposure to CZP was 1313.8 patient-years (PY). AEs were reported in 658 (25.5%) patients, at an event rate (ER) of 73.68/100 PY. The most frequent serious AEs were pneumonia, herpes zoster, and interstitial lung disease, at ER per 100 PY of 2.06, 1.29, and 1.22, respectively. Mean disease activity scores at baseline, as measured by DAS28-ESR and DAS28-CRP, were 4.77 ± 1.34 and 4.21 ± 1.27, respectively. Mean changes from baseline at the last observation were -1.29 ± 1.46 and -1.30 ± 1.42, respectively. EULAR good or moderate responses were achieved in 65% of patients. Longer disease duration, prior biologics use, and treatment without MTX co-therapy were associated with EULAR no response. In this interim analysis, no new safety signals were observed. Clinical response to CZP was observed in approximately two thirds of patients.

  12. The service industry strategy-A case study of tourism hotel in Taiwan

    Science.gov (United States)

    Lu, Chunwei; Huang, Jui-Chan; Wen, Hao-Ming; Hairui, Ji

    2017-06-01

    Regarding to raising living standard in Taiwan, service industry had stand more than 65% GDP and manufacturing is around 35% recently. The data from Council for Economic Planning and Development of Taiwan, in 2015, the service industry stand more than 73% of GDP, and the tourism industry has played one of the most important rules. In service industry, recently, the policy of Taiwan government encourages overseas tourists come to Taiwan for resort and it made many new tourism hotels built, and they also had to do the overall reform to satisfy their customers of global, especially respecting on Eastern Asia. In this study, experts and scholars in the fields of industry academia were interviewed. Survey were issued to the object companies and a comparative case study was conducted to analyze the influencing factors and extent to which differences on the competitive edge and strategies of Taiwan tourism hotels and those which benefit most or least from business operation current situation that conducted with governments' support and internal management. By primary data and literature reviews, this study hope that an effective reference for improving industrial competitiveness and models of competitiveness could be available for the governments and the companies.

  13. An Empirical Study on Marketing Effectiveness Evaluation of Green Food Industry

    OpenAIRE

    Yazhou Xiong; Qianxia Lu; Rui Wang

    2015-01-01

    This study aims to evaluate the marketing effectiveness of green food industry in Hubei Province via fuzzy comprehensive evaluation. Based on the cost basis of analysis of present situation, an evaluation system of marketing effectiveness evaluation on green food industry is established from three aspects, including the industry factor, policy factor and marketing performance factor. And fuzzy comprehensive evaluation method is used to make the quantitative research, analyze the major obstacl...

  14. Personal Study Planning in Doctoral Education in Industrial Engineering

    Science.gov (United States)

    Lahenius, K.; Martinsuo, M.

    2010-01-01

    The duration of doctoral studies has increased in Europe. Personal study planning has been considered as one possible solution to help students in achieving shorter study times. This study investigates how doctoral students experience and use personal study plans in one university department of industrial engineering. The research material…

  15. Strategic human resources study of the upstream petroleum industry : the decade ahead

    International Nuclear Information System (INIS)

    2003-10-01

    This report presents the results of a 10 month study of the human resources issues in Canada's upstream petroleum industry. The study identifies workforce demographics, skills, and supply and demand. It also discusses the impact of technology and other key challenges facing human resources issues. The upstream petroleum industry includes exploration and production, service industries, pipeline transmission, natural gas processing, and heavy oil and bitumen extracting and upgrading. The study defined four regions in Canada: Western Canada Sedimentary Basin, the oil sands, the north, and the east coast. The main influences on the management practices within the upstream petroleum industry are: globalization; cyclical economic conditions; operational excellence business models; government regulatory requirements; stakeholder expectations for involvement; technological advances; changing demographics, and workplace skills. The study also presented suggestions for changes in best practices to improve the efficiency and effectiveness of product and service delivery. refs., tabs., figs

  16. Safety and Effectiveness of Once-Daily Tadalafil (5 mg) Therapy in Korean Men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms in a Real-World Clinical Setting: Results from a Post-Marketing Surveillance Study.

    Science.gov (United States)

    Won, Ji Eon; Chu, Ji Yeon; Choi, Hyunah Caroline; Chen, Yun; Park, Hyun Jun; Dueñas, Héctor José

    2018-05-01

    The aim of this study was to investigate the safety and effectiveness of tadalafil 5 mg once daily (quaque die [everyday], QD) among Korean men with benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) in a real-world clinical setting. This was a single-country, prospective, observational cohort study in which patients newly prescribed tadalafil 5 mg QD for the treatment of BPH/LUTS were followed-up for 12±2 or 24±2 weeks, or to the last treatment, during post-marketing surveillance. Safety was evaluated in terms of the frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Effectiveness was assessed by changes in the International Prostate Symptom Score (IPSS) from baseline to each endpoint. All patients receiving ≥1 dose of tadalafil 5 mg QD (N=637) were included in the safety population. Two percent of patients (n=13) experienced 15 TEAEs of mild (n=10; 66.7%) or moderate (n=5; 33.3%) severity. No severe TEAEs and no SAEs were reported. Effectiveness evaluations included all patients receiving tadalafil who had both baseline and endpoint observations (12-week, N=265; 24-week, N=44). Compared with baseline, the mean IPSS total score (±standard error) significantly improved by 4.7±0.3 and 6.4±0.7 points at the 12- and 24-week endpoints, respectively (peffective in Korean men with BPH/LUTS in a real-world clinical setting. Copyright © 2018 Korean Society for Sexual Medicine and Andrology.

  17. Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.

    Science.gov (United States)

    Endrikat, J; Schwenke, C; Prince, M R

    2015-07-01

    To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Rates of reported ADRs were lower in elderly patients versus adults aged statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. Copyright © 2015 The Royal College of Radiologists. All rights reserved.

  18. IDENTIFYING MARKETING EFFECTIVENESS METRICS (Case study: East Azerbaijan`s industrial units)

    OpenAIRE

    Faridyahyaie, Reza; Faryabi, Mohammad; Bodaghi Khajeh Noubar, Hossein

    2012-01-01

    The Paper attempts to identify marketing eff ectiveness metrics in industrial units. The metrics investigated in this study are completely applicable and comprehensive, and consequently they can evaluate marketing eff ectiveness in various industries. The metrics studied include: Market Share, Profitability, Sales Growth, Customer Numbers, Customer Satisfaction and Customer Loyalty. The findings indicate that these six metrics are impressive when measuring marketing effectiveness. Data was ge...

  19. 2003 Industry Studies: Shipbuilding

    Science.gov (United States)

    2003-01-01

    because the industry is too expensive to sustain in peacetime. Corporate income tax on the revenue from trade shipping, income tax on mariners...Act. This legislation would accomplish at least four initiatives: (1) replace the corporate income tax on US-flagged shipping revenue with a flat

  20. Energy efficient policy impact in India: case study of investment in industrial energy efficiency

    International Nuclear Information System (INIS)

    Yang, M.

    2006-01-01

    The objective of this paper is to identify the effectiveness of energy policy and capital investment in energy efficiency technologies in the industrial sector in India. Indian energy policies relating to industrial energy efficiency over the past 25 years are briefly reviewed, and a comparison study of these energy efficiency policies and strategies in India and China has been carried out. Interviews were conducted with a number of government policy-making institutions and a national industrial development bank. The accounts of 26 industrial enterprises which applied and used a loan of the Asian Development Bank were audited for data collection. Field-visits to seven industrial entrepreneurs were undertaken in a case study. Methodologies used in this study include documentation, cross-country reviews on energy policies, questionnaire design and distribution in the industrial sector, and on-site auditing of energy efficiency technologies. This paper concludes that current energy policies and strategies in India need further improvement to promote energy efficiency investment and energy efficiency technology development in the industrial sector. This paper will interest those policy makers and industrial entrepreneurs who are willing to finance energy efficiency projects and improve energy efficiency in the industrial sector. (author)

  1. Energy efficiency policy impact in India: case study of investment in industrial energy efficiency

    International Nuclear Information System (INIS)

    Yang Ming

    2006-01-01

    The objective of this paper is to identify the effectiveness of energy policy and capital investment in energy efficiency technologies in the industrial sector in India. Indian energy policies relating to industrial energy efficiency over the past 25 years are briefly reviewed, and a comparison study of these energy efficiency policies and strategies in India and China has been carried out. Interviews were conducted with a number of government policy-making institutions and a national industrial development bank. The accounts of 26 industrial enterprises which applied and used a loan of the Asian Development Bank were audited for data collection. Field-visits to seven industrial entrepreneurs were undertaken in a case study. Methodologies used in this study include documentation, cross-country reviews on energy policies, questionnaire design and distribution in the industrial sector, and on-site auditing of energy efficiency technologies. This paper concludes that current energy policies and strategies in India need further improvement to promote energy efficiency investment and energy efficiency technology development in the industrial sector. This paper will interest those policy makers and industrial entrepreneurs who are willing to finance energy efficiency projects and improve energy efficiency in the industrial sector

  2. Risk Management Post-Marketing Surveillance for the Abuse of Medications Acting on the Central Nervous System: Expert Panel Report

    Science.gov (United States)

    Johanson, Chris-Ellyn; Balster, Robert L.; Henningfield, Jack E.; Schuster, Charles R.; Anthony, James C.; Barthwell, Andrea G.; Coleman, John J.; Dart, Richard C.; Gorodetzky, Charles W.; O’Keeffe, Charles; Sellers, Edward M.; Vocci, Frank; Walsh, Sharon L.

    2010-01-01

    The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October, 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and eleven recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized. PMID:19783383

  3. Scheduling in the FMCG industry : an industrial case study

    NARCIS (Netherlands)

    Elzakker, van M.A.H.; Zondervan, E.; Raikar, N.B.; Grossmann, I.E.; Bongers, P.M.M.

    2012-01-01

    A problem-specific model is presented for the short-term scheduling problem in the Fast Moving Consumer Goods (FMCG) industry. To increase the computational efficiency, the limited intermediate inventory is modeled indirectly by relating mixing and packing intervals. In addition, the model size is

  4. Simplification of Process Integration Studies in Intermediate Size Industries

    DEFF Research Database (Denmark)

    Dalsgård, Henrik; Petersen, P. M.; Qvale, Einar Bjørn

    2002-01-01

    associated with a given process integration study in an intermediate size industry. This is based on the observation that the systems that eventually result from a process integration project and that are economically and operationally most interesting are also quite simple. Four steps that may be used......It can be argued that the largest potential for energy savings based on process integration is in the intermediate size industry. But this is also the industrial scale in which it is most difficult to make the introduction of energy saving measures economically interesting. The reasons......' and therefore lead to non-optimal economic solutions, which may be right. But the objective of the optimisation is not to reach the best economic solution, but to relatively quickly develop the design of a simple and operationally friendly network without losing too much energy saving potential. (C) 2002...

  5. In Touch With Industry: ICAF Industry Studies, 1997

    Science.gov (United States)

    1997-01-01

    Analysis and Critical Control Program ( HACCP ) food safety system will allow both the Food and Drug Administration and Food Safety and Inspection...actively prevent food safety problems. The HACCP system is a scientific, process-based analysis of potential hazards, a determination of where those...Figure 2.—U.S. Primary Production (Quadrillion Btu) jam . The energy industry is a highly aggregated construct that stretches the definition of

  6. Effects of carbon taxes on different industries by fuzzy goal programming: A case study of the petrochemical-related industries, Taiwan

    International Nuclear Information System (INIS)

    Lee, Cheng F.; Lin, Sue J.; Lewis, Charles; Chang, Yih F.

    2007-01-01

    Implementation of a carbon tax is one of the major ways to mitigate CO 2 emission. However, blanket taxes applied to all industries in a country might not always be fair or successful in CO 2 reduction. This study aims to evaluate the effects of carbon taxes on different industries, and meanwhile to find an optimal carbon tax scenario for Taiwan's petrochemical industry. A fuzzy goal programming approach, integrated with gray prediction and input-output theory, is used to construct a model for simulating the CO 2 reduction capacities and economic impacts of three different tax scenarios. Results indicate that the up-stream industries show improved CO 2 reduction while the down-stream industries fail to achieve their reduction targets. Moreover, under the same reduction target (i.e. return the CO 2 emission amount to year 2000 level by 2020), scenario SWE induces less impact than FIN and EU on industrial GDP. This work provides a valuable approach for researches on model construction and CO 2 reduction, since it applies the gray envelop prediction to determine the boundary values of the fuzzy goal programming model, and furthermore it can take the economic interaction among industries into consideration. (author)

  7. Study of the Utah uranium-milling industry. Volume I. A policy analysis

    International Nuclear Information System (INIS)

    Turley, R.E.

    1980-05-01

    This is the first volume of a two volume study of the Utah Uranium Milling Industry. The study was precipitated by a 1977 report issued by the Western Interstate Nuclear Board entitled Policy Recommendations on Financing Stabilization. Perpetual Surveillance and Maintenance of Uranium Mill Tailings. Volume I of this study is a policy analysis or technology assessment of the uranium milling industry in the state of Utah; specifically, the study addresses issues that deal with the perpetual surveillance, monitoring, and maintenance of uranium tailings piles at the end of uranium milling operations, i.e., following shutdown and decommissioning. Volume II of this report serves somewhat as an appendix. It represents a full description of the uranium industry in the state of Utah, including its history and statements regarding its future. The topics covered in volume I are as follows: today's uranium industry in Utah; management of the industry's characteristic nuclear radiation; uranium mill licensing and regulation; state licensing and regulation of uranium mills; forecast of future milling operations; policy needs relative to perpetual surveillance, monitoring, and maintenance of tailings; policy needs relative to perpetual oversight; economic aspects; state revenue from uranium; and summary with conclusions and recommendations. Appendices, figures and tables are also presented

  8. Barriers to innovation in small-scale industries: case study from the briquetting industry in India

    NARCIS (Netherlands)

    Clancy, Joy S.

    2001-01-01

    This paper focuses on the innovation process in small- and medium-scale industries in developing countries, raking the briquetting (densification of biomass) as a case study. The technical efficiency was found to vary significantly between firms, which can be attributed to the lack of technological

  9. EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.

    Science.gov (United States)

    de Wilde, Sofieke; Coppens, Delphi G M; Hoekman, Jarno; de Bruin, Marie L; Leufkens, Hubert G M; Guchelaar, Henk-Jan; Meij, Pauline

    2018-03-21

    A comparative analysis of assessment procedures for authorization of all European Union (EU) applications for advanced therapy medicinal products (ATMPs) shows that negative opinions were associated with a lack of clinical efficacy and identified severe safety risks. Unmet medical need was often considered in positive opinions and outweighed scientific uncertainties. Numerous quality issues illustrate the difficulties in this domain for ATMP development. Altogether, it suggests that setting appropriate standards for ATMP authorization in Europe, similar to elsewhere, is a learning experience. The experimental characteristics of authorized ATMPs urge regulators, industry, and clinical practice to pay accurate attention to post-marketing risk management to limit patient risk. Methodologies for ATMP development and regulatory evaluations need to be continuously evaluated for the field to flourish. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. Treatability study of pesticide-based industrial wastewater.

    Science.gov (United States)

    Shah, Kinnari; Chauhan, L I; Galgale, A D

    2012-10-01

    This paper finds out appropriate treatment methods for wastewater of an Organophosphorus viz, chloropyrifos pesticide manufacturing industry. The characterization of wastewater generated during trial production of chloropyrifos was carried out. Based on the characterization of wastewater, various treatability studies were conducted. The most desirable results were obtained with treatment scheme employing acidification, chlorination with NaOCl, suspended growth biological treatment, chemical precipitation for phosphorous removal and activated carbon treatment. Acidification of wastewater helps in by-product recovery as well as reduction in COD upto 36.26%. Chlorination followed by biological treatment was found to be effective to reduce the COD level by 62.06%. To comply with permissible limits prescribed by Effluent Channel Project Ltd.(ECPL)* and Gujarat Pollution Control Board (GPCB) for discharge of industrial effluent into channel, further treatment in the form of chemical precipitation (for phosphorous removal) and granular activated carbon is suggested.

  11. Differing Perceptions Concerning Research Integrity Between Universities and Industry: A Qualitative Study.

    Science.gov (United States)

    Godecharle, Simon; Nemery, Benoit; Dierickx, Kris

    2017-09-14

    Despite the ever increasing collaboration between industry and universities, the previous empirical studies on research integrity and misconduct excluded participants of biomedical industry. Hence, there is a lack of empirical data on how research managers and biomedical researchers active in industry perceive the issues of research integrity and misconduct, and whether or not their perspectives differ from those of researchers and research managers active in universities. If various standards concerning research integrity and misconduct are upheld between industry and universities, this might undermine research collaborations. Therefore we performed a qualitative study by conducting 22 semi-structured interviews in order to investigate and compare the perspectives and attitudes concerning the issues of research integrity and misconduct of research managers and biomedical researchers active in industry and universities. Our study showed clear discrepancies between both groups. Diverse strategies in order to manage research misconduct and to stimulate research integrity were observed. Different definitions of research misconduct were given, indicating that similar actions are judged heterogeneously. There were also differences at an individual level, whether the interviewees were active in industry or universities. Overall, the management of research integrity proves to be a difficult exercise, due to many diverse perspectives on several essential elements connected to research integrity and misconduct. A management policy that is not in line with the vision of the biomedical researchers and research managers is at risk of being inefficient.

  12. An Evaluation Model for Sustainable Development of China’s Textile Industry: An Empirical Study

    Science.gov (United States)

    Zhao, Hong; Lu, Xiaodong; Yu, Ting; Yin, Yanbin

    2018-04-01

    With economy’s continuous rapid growth, textile industry is required to search for new rules and adjust strategies in order to optimize industrial structure and rationalize social spending. The sustainable development of China’s textile industry is a comprehensive research subject. This study analyzed the status of China’s textile industry and constructed the evaluation model based on the economical, ecologic, and social benefits. Analytic Hierarchy Process (AHP) and Data Envelopment Analysis (DEA) were used for an empirical study of textile industry. The result of evaluation model suggested that the status of the textile industry has become the major problems in the sustainable development of China’s textile industry. It’s nearly impossible to integrate into the global economy if no measures are taken. The enterprises concerned with the textile industry status should be reformed in terms of product design, raw material selection, technological reform, technological progress, and management, in accordance with the ideas and requirements of sustainable development. The results of this study are benefit for 1) discover the main elements restricting the industry’s sustainable development; 2) seek for corresponding solutions for policy formulation and implementation of textile industry; 3) provide references for enterprises’ development transformation in strategic deployment, fund allocation, and personnel assignment.

  13. Study on waste waters of metal finishing industries around Lahore metropolitan area

    International Nuclear Information System (INIS)

    Khan, Izhar-ul-Haq; Mahmood, F.; Tufail, S.; Naeem, M.

    2002-01-01

    Study was undertaken on the waste water samples from metal finishing industries of Lahore metropolitan area for the evaluation of metallic impurities. The metal finishing industry was classified into three categories i. e. medium scale, small scale and cottage scale industry. About 93 wastewater samples were collected from various metal finishing industries around Lahore metropolitan area. In addition to toxic elements like cadmium, nickel and zinc the other parameters such as hydrogen ion concentration (pH), Electrical conductivity (EC) and Total Dissolved Salts (TDS) were also determined. (author)

  14. Risk Factor for Diabetes Mellitus and High Blood Glucose With HMG-CoA Reductase Inhibitors Using a Postmarketing Surveillance Database in Japan.

    Science.gov (United States)

    Hashiguchi, Masayuki; Maruyama, Junya; Shimizu, Mikiko; Takahashi, Daichi; Shiga, Tsuyoshi

    2018-02-20

    To investigate whether 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor (statin) use is associated with an increased risk of diabetes mellitus and hyperglycemia, we performed a nested case-control study using a postmarketing surveillance database in Japan. The database cohort included 26,849 cases of statin use and 5308 cases of other lipid-lowering drug use in patients with hyperlipidemia. Participants received at least 1 type of statin, had a clear medication history of statin use, and had no complications of diabetes mellitus. Cases were defined as onset of diabetes mellitus or hyperglycemia during statin intake. For each case, 20 controls were randomly selected and matched by time point. The factors associated with an increased risk of diabetes mellitus and hyperglycemia during statin intake examined included sex, age, body mass index, statin use duration, complications, concomitant medication, and clinical laboratory tests. Statin-associated diabetes mellitus or hyperglycemia was identified based on abnormal elevation of blood glucose concentrations beyond the reference range. A total of 19,868 patients met the inclusion criteria, of whom 24 were patients in the case group. Two complicating factors, fatty liver (adjusted odds ratio 16.10) and hyperuricemia (adjusted odds ratio 28.96), were extracted for onset of diabetes mellitus or hyperglycemia. Nonalcoholic fatty liver was associated with diabetes mellitus, obesity, and insulin resistance, and hyperuricemia was associated with lifestyle. This study suggested that the onset of diabetes mellitus or hyperglycemia might be increased with statin use in patients with complications of fatty liver and hyperuricemia. © 2018, The American College of Clinical Pharmacology.

  15. Drug-induced lung injury associated with sorafenib: analysis of all-patient post-marketing surveillance in Japan.

    Science.gov (United States)

    Horiuchi-Yamamoto, Yuka; Gemma, Akihiko; Taniguchi, Hiroyuki; Inoue, Yoshikazu; Sakai, Fumikazu; Johkoh, Takeshi; Fujimoto, Kiminori; Kudoh, Shoji

    2013-08-01

    Sorafenib is a multi-kinase inhibitor currently approved in Japan for unresectable and/or metastatic renal cell carcinoma and unresectable hepatocellular carcinoma. Although drug-induced lung injury has recently been the focus of interest in Japanese patients treated with molecular targeting agents, the clinical features of patients receiving sorafenib remain to be completely investigated. All-patient post-marketing surveillance data was obtained within the frame of Special Drug Use Investigation; between April 2008 and March 2011, we summarized the clinical information of 62 cases with drug-induced lung injury among approximately 13,600 sorafenib-treated patients in Japan. In addition, we summarized the results of evaluation by a safety board of Japanese experts in 34 patients in whom pulmonary images were available. For the calculation of reporting frequency, interim results of Special Drug Use Investigation were used. In the sets of completed reports (2,407 in renal cell carcinoma and 647 in hepatocellular carcinoma), the reporting frequency was 0.33 % (8 patients; fatal, 4/8) and 0.62 % (4 patients; fatal, 2/4), respectively. Major clinical symptoms included dyspnea, cough, and fever. Evaluation of the images showed that 18 cases out of 34 patients had a pattern of diffuse alveolar damage. The patients with hepatocellular carcinoma showed a greater incidence and earlier onset of lung injury than those with renal cell carcinoma. Although the overall reporting frequency of sorafenib-induced lung injury is not considered high, the radiological diffuse alveolar damage pattern led to a fatal outcome. Therefore, early recognition of sorafenib-induced lung injury is crucial for physicians and patients.

  16. [Safety and efficacy of docetaxel in prostate cancer patients: based on the post-marketing surveillance in Japan].

    Science.gov (United States)

    Mera, Takeshi; Saijo, Nagahiro; Akaza, Hideyuki

    2012-04-01

    The safety and efficacy of docetaxel in prostate cancer were evaluated based on the results of post-marketing surveillance. 149 patients were enrolled between September 2008 and May 2010. The starting dose of docetaxel was 75 mg/m² in 53 patients(36%), 70 mg/m² in 55 (37%), and ≤ 60 mg/m² in 41(28%). The median number of treatment cycles was 8 (range, 1 to 10). There was no age difference observed in the starting doses and the treatment cycles. The most common ≥ grade 3 adverse drug reactions (ADRs) were neutropenia (71%)and leukocytopenia (51%), and they occurred more frequently in patients receiving ≥ 70 mg/m². However, the multi-variate analyses revealed that ≥ grade 3 ADRs did not correlate with the starting doses. Infection-related events (≥ grade 3) and interstitial pneumonia were observed in 15% and 1% of patients, respectively. Prostate-specific-antigen (PSA) flare appeared in 19% of 95 evaluable patients at median period of 26 days from treatment initiation. It continued with median duration of 39. 5 days. PSA response rate as defined ≥ 50% level decline was 37%(95%confidence interval: 27-47) in evaluable patients. It was low in patients receiving ≤ 60 mg/m² (18%). There was no notable difference between patients with initial dose of 75 and 70 mg/m². Further investigation for the longer term is warranted.

  17. A large, multicentre, observational, post-marketing surveillance study of the 2:1 formulation of follitropin alfa and lutropin alfa in routine clinical practice for assisted reproductive technology.

    Science.gov (United States)

    Bühler, Klaus; Naether, Olaf G J; Bilger, Wilma

    2014-01-14

    Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) both have a role to play in follicular development during the natural menstrual cycle. LH supplementation during controlled ovarian stimulation (COS) for assisted reproductive technology (ART) is used for patients with hypogonadotropic hypogonadism. However, the use of exogenous LH in COS in normogonadotropic women undergoing ART is the subject of debate. The aim of this study was to investigate characteristics of infertile women who received the 2:1 formulation of follitropin alfa and lutropin alfa (indicated for stimulation of follicular development in women with severe LH and FSH deficiency) in German clinical practice. A 3-year, multicentre, open-label, observational/non-interventional, post-marketing surveillance study of women (21-45 years) undergoing ART. Primary endpoint: reason for prescribing the 2:1 formulation of follitropin alfa and lutropin alfa. Secondary variables included: COS duration/dose; oocytes retrieved; fertilization; clinical pregnancy; ovarian hyperstimulation syndrome (OHSS). In total, 2220 cycles were assessed; at least one reason for prescribing the 2:1 formulation was given in 1834/2220 (82.6%) cycles. Most common reasons were: poor ovarian response (POR) (39.4%), low baseline LH (17.8%), and age (13.8%). COS: mean dose of the 2:1 formulation on first day, 183.1/91.5 IU; mean duration, 10.8 days. In 2173/2220 (97.9%) cycles, human chorionic gonadotrophin was administered. Oocyte pick-up (OPU) was attempted in 2108/2220 (95.0%) cycles; mean (standard deviation) 8.0 (5.4) oocytes retrieved/OPU cycle. Fertilization (≥1 oocyte fertilized) rates: in vitro fertilization (IVF), 391/439 (89.1%) cycles; intracytoplasmic sperm injection (ICSI)/IVF + ICSI, 1524/1613 (94.5%) cycles. Clinical pregnancy rate: all cycles, 25.9%; embryo transfer cycles, 31.3%. OHSS: hospitalization for OHSS, 8 (0.36%) cycles, Grade 2, 60 (2.7%), and Grade 3, 1 (0.05%). In German routine clinical

  18. A study of hierarchical structure on South China industrial electricity-consumption correlation

    Science.gov (United States)

    Yao, Can-Zhong; Lin, Ji-Nan; Liu, Xiao-Feng

    2016-02-01

    Based on industrial electricity-consumption data of five southern provinces of China from 2005 to 2013, we study the industrial correlation mechanism with MST (minimal spanning tree) and HT (hierarchical tree) models. First, we comparatively analyze the industrial electricity-consumption correlation structure in pre-crisis and after-crisis period using MST model and Bootstrap technique of statistical reliability test of links. Results exhibit that all industrial electricity-consumption trees of five southern provinces of China in pre-crisis and after-crisis time are in formation of chain, and the "center-periphery structure" of those chain-like trees is consistent with industrial specialization in classical industrial chain theory. Additionally, the industrial structure of some provinces is reorganized and transferred in pre-crisis and after-crisis time. Further, the comparative analysis with hierarchical tree and Bootstrap technique demonstrates that as for both observations of GD and overall NF, the industrial electricity-consumption correlation is non-significant clustered in pre-crisis period, whereas it turns significant clustered in after-crisis time. Therefore we propose that in perspective of electricity-consumption, their industrial structures are directed to optimized organization and global correlation. Finally, the analysis of distance of HTs verifies that industrial reorganization and development may strengthen market integration, coordination and correlation of industrial production. Except GZ, other four provinces have a shorter distance of industrial electricity-consumption correlation in after-crisis period, revealing a better performance of regional specialization and integration.

  19. Provincial labour market study : mould remediation industry

    International Nuclear Information System (INIS)

    2003-06-01

    Indoor exposure to mold can be problematic to human health, and some molds are considered to be toxigenic. The emergent mold remediation industry in Ontario is fragmented, with various different standards, training and certification processes. This report investigated the labour market for mold remediation workers, with particular reference to training needs and priorities. Research was derived from a literature review in order to analyze the economic, legal, technical and social context of the mold remediation industry. Data on the organized work force were obtained from records of the International Union of Painters and Allied Trades, the Labour Force Historical Review 2002, and various publications. Population data from the Ontario government and Statistics Canada were also used. Surveys of workers and employers were conducted with questionnaires. Results of the surveys indicated that mold remediation projects currently constitute a minority share of most companies' business. However, the importance of mold remediation projects is expected to increase, and industry self-regulation is the most likely scenario for the development of standards and related training programs. It was suggested that the creation of an industry body representing key stakeholder constituencies or the legitimization of an existing industry organization will reduce fragmentation and facilitate research, standard setting and certification, as well as improve marketing and education. If the demand for mold remediation services increases as anticipated, the industry will face the challenge of remaining competitive in the province's projected labour market due to shortages in personnel. There was a strong consensus between employers and workers in the mold remediation industry regarding the need for skills upgrading and compulsory certification. It was concluded that leadership is needed in the development and delivery of training programs, standard setting, recruitment and retention and

  20. Designing human-robot collaborations in industry 4.0: explorative case studies

    DEFF Research Database (Denmark)

    Kadir, Bzhwen A; Broberg, Ole; Souza da Conceição, Carolina

    2018-01-01

    We are experiencing an increase in human-robot interactions and the use of collaborative robots (cobots) in industrial work systems. To make full use of cobots, it is essential to understand emerging challenges and opportunities. In this paper, we analyse three successful industrial case studies...... of cobots’ implementation. We highlight the top three challenges and opportunities, from the empirical evidence, relate them to current available literature on the topic, and use them to identify key design factor to consider when designing industrial work system with human-robot collaborations....

  1. Study, design and manufacture eddy current probes for industry applications

    International Nuclear Information System (INIS)

    Nguyen Phuc; Nguyen Van Thuy; Vuong Binh Duong; Do Minh Duc; Trinh Dinh Truong; Tran Trong Duc; Do Tung Khanh; Dang Quang Trung

    2016-01-01

    This study is based on the studying, designing and manufacturing of eddy current probes for industry applications. The main tasks of this study include: i) Describes the overview and classification of eddy current probes (which can be classified into three categories based on the mode of operation: absolute eddy current probe, differential eddy current probe and reflect eddy current probe); ii) Describes the three methods of probe designing and manufacturing (including experimental, analytical and numerical designs); iii) Describes the designing and manufacturing of eddy current probes for industry applications, which based on experimental and analytical methods. Based on this study, we have successfully manufactured some current probes (including absolute eddy current probe, differential eddy current probe and reflect eddy current probe) for surface and tube inspections. (author)

  2. Assessment Study on Sensors and Automation in the Industries of the Future. Reports on Industrial Controls, Information Processing, Automation, and Robotics

    Energy Technology Data Exchange (ETDEWEB)

    Bennett, Bonnie [Adventium Labs; Boddy, Mark [Adventium Labs; Doyle, Frank [Univ. of California, Santa Barbara, CA (United States); Jamshidi, Mo [Univ. of New Mexico, Albuquerque, NM (United States); Ogunnaike, Tunde [Univ. of Delaware, Newark, DE (United States)

    2004-11-01

    This report presents the results of an expert study to identify research opportunities for Sensors & Automation, a sub-program of the U.S. Department of Energy (DOE) Industrial Technologies Program (ITP). The research opportunities are prioritized by realizable energy savings. The study encompasses the technology areas of industrial controls, information processing, automation, and robotics. These areas have been central areas of focus of many Industries of the Future (IOF) technology roadmaps. This report identifies opportunities for energy savings as a direct result of advances in these areas and also recognizes indirect means of achieving energy savings, such as product quality improvement, productivity improvement, and reduction of recycle.

  3. Configuration of supply chains in emerging industries: a multiple-case study in the wave-and-tidal energy industry

    OpenAIRE

    Bjørgum, Øyvind; Netland, Torbjørn H.

    2017-01-01

    Companies in emerging industries face particular challenges in configuring effective supply chains. In this paper, we build on transaction cost economics to explore how supply chains can be configured in emerging industries. We focus on two key aspects of supply chain configuration: the make-or-buy decision and the strength of the ties between a focal firm and its suppliers. We utilise a multiple-case study methodology, including seven start-up companies in the emerging wave-and-tidal energy ...

  4. Laboratory and Feasibility Study for Industrial Wastewater Effluents Treatment by Radiation

    Energy Technology Data Exchange (ETDEWEB)

    Zimek, Z.; Głuszewski, W. [Centre for Radiation Research and Technology, Institute of Nuclear Chemistry and Technology, Warsaw (Poland)

    2012-07-01

    The study of wastewater treatment by radiation regarding chemical processes contribution and physical-chemical separation of highly concentrated non-organic pollutants deposited in specific industrial waste are proposed. Laboratory stand should be build and the study should be performed to confirm possible mechanism of the sedimentation process of nonorganic pollutants during separation initiated by ionizing radiation. Evaluation from technical and economical point of view of this specific radiation technology and feasibility study preparation for industrial facility will be the main output at the final stage of the project. (author)

  5. Laboratory and Feasibility Study for Industrial Wastewater Effluents Treatment by Radiation

    International Nuclear Information System (INIS)

    Zimek, Z.; Głuszewski, W.

    2012-01-01

    The study of wastewater treatment by radiation regarding chemical processes contribution and physical-chemical separation of highly concentrated non-organic pollutants deposited in specific industrial waste are proposed. Laboratory stand should be build and the study should be performed to confirm possible mechanism of the sedimentation process of nonorganic pollutants during separation initiated by ionizing radiation. Evaluation from technical and economical point of view of this specific radiation technology and feasibility study preparation for industrial facility will be the main output at the final stage of the project. (author)

  6. A study on important factors influencing innovation in service: A case study of hotel industry

    Directory of Open Access Journals (Sweden)

    Koorosh Kohyari Haghighat

    2013-07-01

    Full Text Available Hotel industry plays important role on developing tourism industry and having better services in this industry always help increase market share. The proposed study of this paper considers the effects of four variables including collaboration with staff, collaboration with customers, collaboration with partners and business owners and finally mechanism of integration of knowledge on innovation on service. The population of this survey includes 259 hotels where we send our questionnaire to 179 and manage to collect 170 ones. Cronbach alpha for four variables including collaboration with staff, collaboration with customers, collaboration with partners and business owners and finally mechanism of integration of knowledge were calculated as 0.78, 0.865, 0.743 and 0.890, respectively. The proposed study uses structural equation modeling to study the relationship between independent variables and dependent variable and the effects of four variables are confirmed when the level of significance is five percent.

  7. 2001 Industry Studies: Aircraft

    Science.gov (United States)

    2001-01-01

    improving the quality of products and the speed of bringing products to market . However, substantial issues remain concerning information security... information technology professionals, managers, technicians, and mechanics are being lost. Competition from other industries, aging of the work force...observing the high demand and salaries for information technology professionals and the decline of long-term technologically challenging prospects for

  8. Effects of carbon taxes on different industries by fuzzy goal programming: A case study of the petrochemical-related industries, Taiwan

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Cheng F. [Diwan University, Tainan (China). Department of Environment and Resources Engineering; Lin, Sue J. [National Cheng Kung University, Tainan (China). Department of Environmental Engineering, SERC; Lewis, Charles [National Cheng Kung University, Tainan (China). Department of Resources Engineering; Chang, Yih F. [Chia Nan University of Pharmacy and Science, Tainan (China). Department of Tourism Management

    2007-08-15

    Implementation of a carbon tax is one of the major ways to mitigate CO{sub 2} emission. However, blanket taxes applied to all industries in a country might not always be fair or successful in CO{sub 2} reduction. This study aims to evaluate the effects of carbon taxes on different industries, and meanwhile to find an optimal carbon tax scenario for Taiwan's petrochemical industry. A fuzzy goal programming approach, integrated with gray prediction and input-output theory, is used to construct a model for simulating the CO{sub 2} reduction capacities and economic impacts of three different tax scenarios. Results indicate that the up-stream industries show improved CO{sub 2} reduction while the down-stream industries fail to achieve their reduction targets. Moreover, under the same reduction target (i.e. return the CO{sub 2} emission amount to year 2000 level by 2020), scenario SWE induces less impact than FIN and EU on industrial GDP. This work provides a valuable approach for researches on model construction and CO{sub 2} reduction, since it applies the gray envelop prediction to determine the boundary values of the fuzzy goal programming model, and furthermore it can take the economic interaction among industries into consideration. (author)

  9. Discontentment and knowledge spillovers in an emerging high-tech industry: a study of the emergence of the RFID industry

    OpenAIRE

    Finn, David J.

    2009-01-01

    This thesis is an inductive study of how entrepreneurs and their collaborators use or encourage knowledge spillovers to fuel technological innovations during the emergence of a knowledge intensive industry. Drawing on theories of the entrepreneurial process, innovation during industry emergence, and knowledge spillovers, this thesis seeks to explain the process by which entrepreneurs, facing market, organizational and technological uncertainty, use their existing knowledge to procure, share a...

  10. Foresight Model of Turkey's Defense Industries' Space Studies until 2040

    Science.gov (United States)

    Yuksel, Nurdan; Cifci, Hasan; Cakir, Serhat

    2016-07-01

    Being advanced in science and technology is inevitable reality in order to be able to have a voice in the globalized world. Therefore, for the countries, making policies in consistent with their societies' intellectual, economic and political infrastructure and attributing them to the vision having been embraced by all parties of the society is quite crucial for the success. The generated policies are supposed to ensure the usage of countries' resources in the most effective and fastest way, determine the priorities and needs of society and set their goals and related roadmaps. In this sense, technology foresight studies based on justified forecasting in science and technology have critical roles in the process of developing policies. In this article, Foresight Model of Turkey's Defense Industries' Space Studies, which is turned out to be the important part of community life and fundamental background of most technologies, up to 2040 is presented. Turkey got late in space technology studies. Hence, for being fast and efficient to use its national resources in a cost effective way and within national and international collaboration, it should be directed to its pre-set goals. By taking all these factors into consideration, the technology foresight model of Turkey's Defense Industry's Space Studies was presented in the study. In the model, the present condition of space studies in the World and Turkey was analyzed; literature survey and PEST analysis were made. PEST analysis will be the inputs of SWOT analysis and Delphi questionnaire will be used in the study. A two-round Delphi survey will be applied to the participants from universities, public and private organizations operating in space studies at Defense Industry. Critical space technologies will be distinguished according to critical technology measures determined by expert survey; space technology fields and goals will be established according to their importance and feasibility indexes. Finally, for the

  11. An exploration study to find important factors in market entrance: A case study of truck industry

    Directory of Open Access Journals (Sweden)

    Zoheir Khodamoradi

    2013-09-01

    Full Text Available This paper presents an empirical investigation to find important factors influencing market penetration in truck industry. The proposed study designs a questionnaire in Likert scale consists of 51 questions, distributes it among 300 people who worked for different truck industry related units and collects 262 filled ones. Cronbach alpha is calculated as 0.89. In addition, Kaiser-Meyer-Olkin Measure of Sampling Adequacy and Approx. Chi-Square are 0.845 and 3067.443, respectively. The study has implemented principal component analysis and the results have indicated that there were eight factors influencing entering truck making industry including adaptation strategies, new ideas, cost competitiveness, product capabilities, market characteristics, competition threats from external market environment and export accelerators.

  12. Land Combat Systems Industry. Industry Study, Spring 2009

    Science.gov (United States)

    2009-01-01

    such a technology hastened to production that might cause what the government tends to call “technological surprise” is Friction Stir Welding . This...Success Stories. “ Friction Stir Welding of Aluminum Armor”. March 2002. Available online: http://www.onr.navy.mil/sci_tech/3t/mantech/docs...supply tenders as well as other factors.4 Competition in the industry is typically low and steady, but affected by increased LCS funding along with the

  13. General Considerations on Leadership in the Hospitality Industry. Conceptual Analysis and Practical Studies

    OpenAIRE

    Andreia ISPAS

    2010-01-01

    Leadership in the hospitality industry is still an open research field especially in describing the effects of leadership style on hotel employees. The purpose of the paper is to present and analyze the following concepts: leadership and leadership style, hospitality industry; the practical aspects of leadership in the hospitality industry and to identify relevant studies regarding the importance of leadership styles applied in this industry. The research methodology consists of analyzing the...

  14. SOFTWARE IN TOURISM INDUSTRY : A Study On Emerging New Niches Of Software In Hotel Industry

    OpenAIRE

    Regmi, Krishna Kumar; Thapa, Bikesh

    2010-01-01

    This study was structured as a part of Bachelor Degree thesis in Tourism Degree Programme in Laurea University of Applied Sciences. The study examines the role of software as a major component of ICTs (Information and Communication Technologies) in hotel industry in Finland. The study was conducted in three major hotel chains in Finland in order to identify the scope and possibility of developing new software module within the periphery of contemporary Property Management Systems (PMS). Marke...

  15. Long-Term Effectiveness of the Zilver PTX Drug-Eluting Stent for Femoropopliteal Peripheral Artery Disease in Patients with No Patent Tibial Runoff Vessels-Results from the Zilver PTX Japan Post-Market Surveillance Study.

    Science.gov (United States)

    Cipollari, Stefano; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Saunders, Alan T; Dake, Michael D

    2018-01-01

    To evaluate 2-year results of the Zilver PTX (Cook Medical, Bloomington, Indiana) drug-eluting stent (DES) for femoropopliteal peripheral artery disease (PAD) in patients with no continuous patent infrapopliteal runoff arteries compared with patients with ≥ 1 continuous patent runoff vessels. A retrospective analysis of patients with femoropopliteal PAD enrolled in the Zilver PTX Post-Market Surveillance Study in Japan was performed. There were no exclusion criteria. Outcomes, including freedom from target lesion revascularization (TLR), patency, and clinical benefit, for the no-runoff group (n = 54) were compared with the runoff group (n = 846). The 2 groups were similar in terms of demographics, lesion characteristics, and comorbidities (P > .05). There was a higher incidence of critical limb ischemia in the no-runoff group compared with the runoff group (44.8% vs 19.7%; P < .01). There were 3 amputations (5.6%) in the no-runoff group versus 7 amputations (0.8%) in the runoff group (P = .02). At 2 years, freedom from TLR rates were 81.3% versus 83.8% (P = .87), patency rates were 68.4% versus 70.7% (P = .95), and clinical benefit rates were 73.7% versus 80.0% (P = .16) in the no-runoff versus runoff group, respectively. Results in patients with no continuous patent tibial runoff were favorable through 2 years and similar to results for patients with ≥ 1 continuous patent runoff vessels, indicating that the Zilver PTX DES may be a valid treatment option for patients with these difficult-to-treat lesions. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

  16. gender-specific outcome after paclitaxel-eluting stent implantation in japanese patients with coronary artery disease--sub-analysis of the Japan TAXUS Express2 post-marketing survey.

    Science.gov (United States)

    Okura, Hiroyuki; Nakamura, Masato; Kotani, Jun-Ichi; Kozuma, Ken

    2013-01-01

     Although previous randomized and non-randomized studies have demonstrated the safety and efficacy of paclitaxel-eluting stents (PES), a higher revascularization rate has been reported in women than in men. A sub-analysis of the TAXUS Japan Post-market Surveillance Study (TAXUS-PMS) was done to assess the influence of gender on clinical outcome.  A total of 2,132 PES-treated Japanese patients (women, n=551) from this registry were analyzed. Subjects were stratified by gender to compare 1-year clinical outcome. PES-treated women were older and more likely to have insulin-treated diabetes and hypertension. In contrast, PES-treated men were more likely to be smokers, have a previous history of myocardial infarction, and lower ejection fraction. While cardiac death, myocardial infarction and stent thrombosis were similar between men and women, major cardiac events tended to be lower in women than in men (6.4% vs. 8.8%, P=0.08). Although women had significantly smaller reference vessel size (2.46±0.53 mm vs. 2.59±0.60 mm, Ptarget lesion revascularization rate was significantly lower in women than in men (4.2% vs. 6.5%, P<0.05).  Despite a higher risk profile, Japanese women treated with PES did not have a higher rate of repeat revascularization or major adverse clinical outcome than PES-treated men at 1 year. 

  17. Creating new path for Old Industrial Areas: A Case Study on Dalian city, China

    Directory of Open Access Journals (Sweden)

    Yimei Yin and Zhigao Liu

    2012-01-01

    Full Text Available The formation of new industries has recently been widely studied, but little research attention has been paid to the formation of new industries in old industrial districts, especially in transitional countries such as China. Based on fieldwork and rereading historical archives, this paper uses an example of Dalian tourism cluster to contribute to understanding the emergence of new economy in old industrial areas in a transitional country. The Section 2 of this paper will provide the theoretical framework from evolutionary economics for my empirical study. In Section 3, this paper will discuss the main characteristics of the decline of old industrial areas in Northeast China and the significances of developing new economy to revitalizing old industry areas. Section 4 will introduce the transitional history of Dalian economy from a high industrial region to a new economy city and also provides descriptive information about the development process of Dalian tourism industry. In Section 5, this paper will probe into the dynamics of the Dalian tourism cluster, from viewpoints of co-evolution and co-adaptation of firm, technology and institutions. Finally, we will give some policy suggestions of how to foster and promote new industries in old industrial areas, especially for transitional countries.

  18. Assessment of the effectiveness of the post-Fukushima food monitoring campaign in the first year after the nuclear accident: A hypothesis

    International Nuclear Information System (INIS)

    Steinhauser, Georg

    2016-01-01

    The purpose of this study was to assess whether or not the food monitoring campaign after the Fukushima nuclear accident has been successful in reducing the number of above-limit-food from reaching the consumers. The hypothesis of this study is that the fraction of “post-market” food can be used for this purpose, when the post-market fraction in the above-limit (p′) items is compared to the post-market fraction in the entity of food items (p) that have been screened for radionuclides ("1"3"4Cs and "1"3"7Cs). Indeed the post-market fraction in most vegetarian produce decreased significantly in the above-limit food items (p′/p   1), indicating a much lower effectiveness of the monitoring action for beef. The author speculates that, by following the governmental monitoring manual (which gives “meat” only second priority), the sudden exceedances caught the monitoring agencies unprepared and triggered a much higher density monitoring of beef with the delay of several weeks. Even then, many above limit items reached the market (mainly because the monitoring during this period had focused on the post-market). Therefore, it is likely that some above-limit beef has been consumed by the public. For other meat products, the fraction of post-market samples was very low, which does not allow for the validation of the effectiveness of the monitoring campaign. Overall, the monitoring seemed to have been more effective for vegetarian produce than for meat. - Highlights: • The fraction of post-market food above the regulatory indicates the effectiveness of the monitoring campaign. • Monitoring of vegetables has been more effective than of meat. • Beef had the highest fraction of exceedances in the post-market fraction.

  19. Towards preventative eco-industrial development: an industrial and urban symbiosis case in one typical industrial city in China

    DEFF Research Database (Denmark)

    Dong, Liang; Fujita, Tsuyoshi; Dai, Ming

    2016-01-01

    situation. In order to investigate the eco-benefits of eco-industrial development in China, this study focused on an industrial and urban symbiosis case of Guiyang city in which process synergy, municipal solid wastes recycling and waste energy utilization were incorporated in this typical industrial city...... policy implications to address the barriers of promoting industrial and urban symbiosis were proposed. This study is critical for future industrial and urban planning policy making and shed a light on innovative eco-industrial development in China....

  20. Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: expert panel report.

    Science.gov (United States)

    Johanson, Chris-Ellyn; Balster, Robert L; Henningfield, Jack E; Schuster, Charles R; Anthony, James C; Barthwell, Andrea G; Coleman, John J; Dart, Richard C; Gorodetzky, Charles W; O'Keeffe, Charles; Sellers, Edward M; Vocci, Frank; Walsh, Sharon L

    2009-12-01

    The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and 11 recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized.

  1. Wind energy in industrial areas optional, but not obvious. A study on the chances and constraints for the use of wind energy in industrial parks

    International Nuclear Information System (INIS)

    Schoolderman, J.A.; Verbeet, E.; Jochems, A.; Versteeg, K.

    2000-06-01

    The feasibility of installing wind turbines in industrial parks in the Netherlands has been investigated. An overview is given of possibilities and constraints to fit in wind turbines in industrial areas, based on the results of a literature study, a market consultation of sectoral organizations, representatives of local industrial circles and industrial experts in the field of renewable energy. Also a telephone survey was carried out among 130 entrepreneurs in the Netherlands to determine their attitudes towards the use of sustainable energy and wind energy in industrial parks. The results of the attitude study are published in a separate report for which a separate abstract has been prepared. The intermediate results were discussed at a meeting (23 February 2000), in which representatives from the industry, provinces, municipalities and the government participated

  2. Study and radiological impact assessment produced by activities of different non-nuclear industries. Titanium dioxide industries

    International Nuclear Information System (INIS)

    Garcia-Tenorio, R.; Manjon, G.; Abril, J.M.

    2010-01-01

    After a careful study and evaluation of radiological impact, the conclusion is that these industries do not need to be subject to control, and it is not necessary any corrective action to reduce the exposition and/or to apply any radiation protection measures.

  3. Study on implementation of environmental management system in textile industry in Sudan

    International Nuclear Information System (INIS)

    Mohamed, H. A.

    2010-11-01

    This conducted from June to December, the main objective of this study is to formulate manual for textile industry in Sudan. The data used in this study is secondary data from references, books manuals, web sites and reports. This theoretical data can be executed practically. The quality of life on earth is linked inextricably to the overall quality of the environment. One of the major problems facing the industrial world today is the contamination of soil, ground water, sediments, surface water and air with hazardous toxic chemicals dumped by industries as waste. While regulatory step have been implemented in the recent past to reduce or eliminate the production and release of these chemicals into the environment, significant deterioration of the environment has already occurred so far. Conventional treatments have been used by some industries, but these can be both, expensive and inherently disruptive to the environment. Thus, economical and ecological management of industrial wastes has become a major concern these days. Integrating both economical and ecological methods in waste management by implementation environmental management system in textile sector, to enable textile industry to establish waste minimization programmes, reduction of pollution and reduced environmental impact. Effective waste minimization programmes an essential aspect of any EMS compliance with ISO 14000, reduction in the risk of pollution reliability, enhanced international acceptability, competitiveness and trade. environmental sustain ability and international and national acceptance to this are presented here, which can be used a good database by the organizations which can put into use these approaches for the efficient ecological management of their industrial wastes. The main objective of this to make Sudanese textile industry environmentally friend by establish manual for this. (Author)

  4. Analysis of Expectations of Forest Products Industry from Forest Industry Engineering Education

    OpenAIRE

    GEDİK, Tarık; ÇİL, Muhammet; SEVİM KORKUT, Derya; CEMİL AKYÜZ, Kadri; KOŞAR, Gökşen; BEKAR, İlter

    2016-01-01

    Forest industry engineers, representing the qualified labor within the forest products industry, choose their field of study either deliberately or by chance. This study explores the main skill sets of forest industry engineers required by forest products industry. As representatives of forest industry owner of forest products companies were surveyed about their views on the qualifications a forest industry engineer must have.This study covered total 7111 companies registered to TOBB as a for...

  5. Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

    Science.gov (United States)

    Lu, Zhengwu

    2009-01-01

    Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

  6. P.C. disposal decisions: a banking industry case study

    Science.gov (United States)

    Shah, Sejal P.; Sarkis, Joseph

    2002-02-01

    The service industry and the manufacturing industry are interlinked in a supply chain situation. Part of the effectiveness of some manufacturing industry environmental performance based on remanufacturing and recycling is dependent on service industry decisions. In the information technology arena, personal computers (PCs) are the hard equipment of the service industry. The end-of-life decisions made by the service industry, and in this case the banking industry will have implications for the amount of systems within the waste or reverse logistics stream for manufacturers. Looking at some of the issues (and presenting a model for evaluation) related to decision making concerning end-of-life disposition for PCs is something this paper investigates. The analytical hierarchy process (AHP) is applied in this circumstance. The development of the model, its application, and results, provide the basis for much of the discussion in this paper.

  7. Hydrogeological and geophysics study of Conaprole industrial plant Tarariras Colonia province

    International Nuclear Information System (INIS)

    Cardozo, L.; Mari, C.; Massa, E.; Cicalese, H.

    1985-01-01

    To application of the National Cooperative of Producers of Milk (CONAPROLE), it proceeded to a hydro geologic and geophysical studies for the industrial plant of that Cooperative, located in Tarariras city (Colonia province) where it was determined the technical feasibility of exploration and exploitation of groundwater in one or more waterdrills to be executed in the proximities of the industrial plant .

  8. Equipment Grafting in Telecommunication Industry (Case Study ...

    African Journals Online (AJOL)

    The growth and pace of any industry is a veritable estimation of its viability. The telecommunications industry all over the world is ever burgeoning. Its growth is buoyed by development and technologies. These innovations do not necessarily have to instantaneously supplant the old rather they are procedurally applied to the ...

  9. 2002 Industry Studies: Education

    Science.gov (United States)

    2002-01-01

    1 EDUCATION ABSTRACT United States schools are better than ever, but they are not assuring competitive advantage . Unequal access to quality...competitive advantage , and promote national security. • Demand for education continues to grow as the US transitions from an industrial to a knowledge... international assessments, pose challenges. With human capital constituting our most critical national resource, a world-class education system is vital to

  10. A comparative study of fluorescent and LED lighting in industrial facilities

    Science.gov (United States)

    Perdahci PhD, C.; Akin BSc, H. C.; Cekic Msc, O.

    2018-05-01

    Industrial facilities have always been in search for reducing outgoings and minimizing energy consumption. Rapid developments in lighting technology require more energy efficient solutions not only for industries but also for many sectors and for households. Addition of solid-state technology has brought LED lamps into play and with LED lamp usage, efficacy level has reached its current values. Lighting systems which uses fluorescent and LED lamps have become the prior choice for many industrial facilities. This paper presents a comparative study about fluorescent and LED based indoor lighting systems for a warehouse building in an industrial facility in terms of lighting distribution values, colour rendering, power consumption, energy efficiency and visual comfort. Both scenarios have been modelled and simulated by using Relux and photometric data for the luminaires have been gathered by conducting tests and measurements in an accredited laboratory.

  11. KEBIJAKAN PENGELOLAAN LINGKUNGAN KAWASAN INDUSTRI SESUAI PROPER KLHK PERINGKAT HIJAU (STUDI KASUS DI KAWASAN INDUSTRI JABABEKA BEKASI

    Directory of Open Access Journals (Sweden)

    Temmy Wikaningrum

    2015-07-01

    Full Text Available Environmental management in industrial estate is the strategic policy model which is needed to be developed referring to the Indonesian Government Decree number 24 year 2009, that state almost all of the new industrial developments should be located in industrial estate. The complexity in this environmental management was approached by “green rating” of PROPER’s criteria regulated by Ministry of Environment & Forestry (KLHK. PROPER is the assessment program of company performance rating in environmental management. Green rating is classified by PROPER in terms of beyond compliance performance. The result of the case study in Jababeka Industrial Estate (KIJA Bekasi, based on its environmental situational analysis year 2014 by multidimensional scaling (MDS method, showed that only the management dimension had a sustainability performance. The results of prospective analysis on leverage factors of MDS showed that the key factors of the environmental management model were (1 DRKPL (summary document of environmental management performance, (2 implementation of water conservation and reducing water pollution program, (3funding for water conservation, (4 monitoring and evaluation of community development program, (5 implementation of 3R (reduce, reuse, recycle programs of hazardous waste, (6 technology of 3R, and (7 benchmarking. Based on the key parameters and referred to the possibilities conditions, three scenarios have been developed to approach the implementative policy. The moderate scenario was recommended to be the right policy in term of consideration of technology, funding availability, time of implementation and organization skills.Keywords: environmental management, industrial estate, jababeka, proper KLHK

  12. Analysis of low-carbon industrial symbiosis technology for carbon mitigation in a Chinese iron/steel industrial park: A case study with carbon flow analysis

    International Nuclear Information System (INIS)

    Zhang, Hui; Dong, Liang; Li, Huiquan; Fujita, Tsuyoshi; Ohnishi, Satoshi; Tang, Qing

    2013-01-01

    CO 2 mitigation strategies in industrial parks are a significant component of the Chinese climate change mitigation policy, and industrial symbiosis can provide specific CO 2 mitigation opportunity. Technology is important to support symbiosis, but few studies in China have focused on this topic at the industrial park level. This research presented a case study in a national iron and steel industrial park in China. Focus was given onto carbon mitigation through industrial symbiosis technology using substance flow analysis (SFA). Three typical iron and steel industry technologies, including coke dry quenching (CDQ), combined cycle power plant (CCPP), and CO 2 capture by slag carbonization (CCSC) were evaluated with SFA. Technology assessment was further conducted in terms of carbon mitigation potential and unit reduction cost. Compared with the Business as usual (BAU) scenario, application with CDQ, CCPP, and CCSC reduced the net carbon emissions by 56.18, 134.43, and 222.89 kg CO 2 per ton crude steel inside the industrial parks, respectively, including both direct and indirect emissions. Economic assessment revealed that the unit costs for the three technologies were also high, thereby necessitating national financial support. Finally, relevant policy suggestions and future concerns were proposed and discussed. - Highlights: • A typical carbon mitigation case study on China iron/steel industrial park. • Using carbon SFA to investigate mitigation effects of industrial symbiosis technology. • CCPP greatly reduced the indirect carbon emission embodied in power purchase. • CCSC reduced the carbon emission by distributing fixed carbon into by-product. • Specific low carbon-tech promotion policies fit to China was discussed and proposed

  13. Study of radiation portal monitor and its application to metal recycling industry

    International Nuclear Information System (INIS)

    Pujol, L.; Lara-Calleja, S.; Suarez-Navarro, M. J.; Gonzalez-Gonzalez, J. A.

    2009-01-01

    The industry of the iron and the steel in one of the most important sectors in Spain for its economic development. the recycling of metallic materials as well as the import of metallic scrap is very significant. Several reports on accidental dispersion or smelting of radioactive sources in metal recycling industries confirm the possibility that radioactive material might be mixed with scrap. In consequence, this type of accident shows the necessity of a rigorous and specific radiation control of the sector. The control of these materials with radioactive content can be carried out with radiation portal monitors installed at the entrance of these industries. The detection of radioactive materials presents special features as the continuous background acquisition or the minimisation of the relatively large number of innocent/nuisance detections. In the present work, we study a radiation portal monitor, the FHT-1388-T Thermo-Eberline. This is one of the usual radiation portal systems installed at the entrance of the metal recycling industry. Se study the characteristics and parameters of this portal monitor to optimise its use. furthermore, we propose some rapid tests for radiation portal systems in metal recycling industry. (Author) 16 refs

  14. Safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus: a 1-year post-marketing surveillance in Japan.

    Science.gov (United States)

    Goda, Maki; Yamakura, Tomoko; Sasaki, Kazuyo; Tajima, Takumi; Ueno, Makoto

    2018-02-01

    To evaluate the safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus (T2DM) in clinical settings. The authors conducted a 1-year post-marketing surveillance (PMS) of canagliflozin in almost all the elderly patients (≥65 years old) with T2DM who began taking canagliflozin during the first 3 months after its launch in Japan. The main outcomes included the incidences of adverse drug reactions (ADRs), serious ADRs, and the changes of laboratory tests as well as efficacy variables. An ADR was reported in 9.09% (125 of 1375 patients) in the safety analysis set. The main ADRs were dehydration, constipation, thirst, pollakiuria, dizziness, cystitis, eczema, pruritus, and rash. The incidence of serious ADRs was 1.02% (14 patients), which included urinary tract infection, dehydration, hypoglycemia, and cerebral infarction (two patients each). ADRs of special interest that had been reported in clinical trials of SGLT2 inhibitors, such as hypoglycemia, volume depletion-related events, genital/urinary tract infection, polyuria/pollakiuria, and ketone body increased were also observed in this PMS. The safety profiles were similar to the results of a previous clinical study of canagliflozin, and new safety concerns were not identified in this survey. The mean change in HbA1c was -0.77% after 12 months of treatment in the efficacy analysis set. In this PMS, the safety and efficacy profiles of canagliflozin in elderly patients with T2DM were obtained in the clinical settings in Japan and the drug was well tolerated and effective in improving glycemic control.

  15. Study on eco-efficiency of industrial parks in China based on data envelopment analysis.

    Science.gov (United States)

    Fan, Yupeng; Bai, Bingyang; Qiao, Qi; Kang, Peng; Zhang, Yue; Guo, Jing

    2017-05-01

    China's industrial parks have been playing a crucial role on driving regional economy development, but also been posing threats to local environment due to intensive resource consumption and waste emission. Chinese government facilitated eco-industrial development of industrial park, aiming to output more with less environmental burden. In our study, the eco-efficiency levels of 40 Chinese industrial parks in 2012 were assessed and ranked by Data Envelopment Analysis (DEA). This paper applied indicators relevant to resource, economy, and environment from industrial parks which can well reflect the characteristics of eco-efficiency conforming to the concept of sustainability. This paper introduced how to adjust less sustainable parks to be more sustainable according to the DEA results. The roles of industrial added value per capita, industrial structure, environmental policy and development scale as influence factors of eco-efficiency were discussed. The results show that large differences exist in the eco-efficiency of different industrial parks. It is shown that 20% of the parks are relatively efficient. 47% of the study parks being inefficient in terms of scale efficiency show decreasing returns to scale. Policy implementations for the management of industrial parks were also discussed based on the results. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. [Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

    Science.gov (United States)

    Nakajima, Toshifusa

    2016-04-01

    Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media.

  17. Study on CNPEC's nuclear AE organization, its characteristics and industrial value

    International Nuclear Information System (INIS)

    Zhao Jianguang; Kuang Wei

    2014-01-01

    The paper studies and analyzes CNPEC's AE organizational operation model and its characteristics in details to explore its value and contribution to the reform of Chinese state-owned enterprises. By building the design and construction integration platform, CNPEC integrates the resources of the nuclear industry chain to effectively ensure the whole performance, the safety and high quality of nuclear power plants under construction; by establishing the total quality partnership which focuses on the cross-border quality management and control, CNPEC enhances the quality management level of enterprises in the nuclear industry chain; by promoting the technology development cooperation, CNPEC improves the technological advancement of the whole nuclear industry chain. (authors)

  18. Safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension: Japanese post-marketing surveillance data.

    Science.gov (United States)

    Yamazaki, Hiroyoshi; Kobayashi, Noriko; Taketsuna, Masanori; Tajima, Koyuki; Murakami, Masahiro

    2017-05-01

    To evaluate the long-term safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. This prospective, multicenter, noninterventional, post-marketing surveillance included patients with PAH who were observed for up to 2 years after initiation of tadalafil. Safety was assessed by analyzing the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs). Effectiveness measurements included the assessment of the change in World Health Organization (WHO) functional classification of PAH, 6-minute walk test, cardiac catheterization, and echocardiography. Among 1676 patients analyzed for safety, the overall incidence of ADRs was 31.2%. The common ADRs (≥1.0%) were headache (7.0%), diarrhea (1.9%), platelet count decreased (1.8%), anemia, epistaxis, and nausea (1.6% each), flushing (1.3%), hepatic function abnormal (1.1%), hot flush, and myalgia (1.0% each). The common SADRs (≥0.3%) were cardiac failure (0.7%), interstitial lung disease, worsening of PAH, and platelet count decreased (0.3% each). Among 1556 patients analyzed for effectiveness, the percentages of patients with improvement of WHO functional class at 3 months, 1 year, and 2 years after the initiation of tadalafil, and last observation were 17.1%, 24.8%, 28.9%, and 22.5%, respectively. At all observation points (except pulmonary regurgitation pressure gradient at end diastole at 3 months), the mean 6-minute walk distance, cardiac catheterization, and echocardiogram measurements showed statistically significant improvement. This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in patients with PAH in Japan.

  19. Methodological approaches to developing and establishing the body of evidence on post-marketing Chinese medicine safety.

    Science.gov (United States)

    Liao, Xing; Robinson, Nicola

    2013-07-01

    Evidence based medicine demands the highest form of scientific evidence to demonstrate the efficacy and clinical effectiveness for any therapeutic intervention in order to provide best care. It is however accepted that in the absence of scientific evidence, personal experience and expert opinion together with professional judgement are critical. Obtaining evidence for drug safety, postmarketing surveillance (PMS) has focussed on follow up of observational cohorts exposed to a particular drug in order to estimate the incidence of adverse drug reactions (ADRs). Evidence on PMS of Chinese herbal products is still limited, in particular for herbal injections. The aim of this article is to suggest a new model of ascertaining the safety of Chinese medicine using a more comprehensive approach for collecting data. To collect safety data on the Chinese herbal injection, Kudiezi, a mixed methods approach is proposed using 18 hospital information systems to detect ADRs in order to prospectively observe 30,000 patients over 3 years. Evidence will also be collected using a questionnaire survey and through a sample of semi structured interviews. This information based on the expert opinion and the experience of clinicians will produce additional data on the frequency and types of side effects in clinical practice. Furthermore semi structured interviews with a random sample of patients receiving the injection will be carried out to ascertain any potential side effects missed. It is hoped that this comprehensive approach to data collection will accumulate wider evidence based on individual traditional Chinese medicine care and treatment and provide important feedback to the national data collection system to ensure completeness of ADR data recording, monitoring and any potential wider effects through developing improved ADR guidelines.

  20. THE STUDY OF ORGANIZATIONAL BEHAVIOR ON FISHERY MANUFACTURE INDUSTRIES EMPLOYEES PERFORMANCES

    Directory of Open Access Journals (Sweden)

    Agung Wahyu Handaru

    2015-06-01

    Full Text Available The purpose of this study was to examine the employee performance of fish-based food processing industries in West Java, which driven by variables of organizational culture, job satisfaction and motivation. The fishing industry in Indonesia has resulted in huge foreign exchange. On the other hand, their products are still poor quality and do not meet export standard. This is likely due to low employee performance. The research object were employees of three fish-based food processing plants. The sample was selected by simple random sampling technique. This study revealed different results from previous studies, that only organizational culture has an effect on employee performance. While job satisfaction and motivation has no effect on performance. Tujuan penelitian ini adalah menguji kinerja karyawan industri pengolahan makanan berbasis ikan di wilayah Jawa Barat, yang dipengaruhi dari variabel budaya organisasi, kepuasan kerja dan motivasi. Industri perikanan di Indonesia telahmenghasilkan devisa negara besar. Disisi lain, hasil produknya masih banyak yang belum memenuhi standar ekspor dan bermutu rendah. Hal tersebut kemungkinan dikarenakan kinerja karyawan yang rendah. Objek penelitian ini adalah karyawan dari tiga pabrik pengolahan makanan berbasis ikan. Sampel dipilih dengan teknik simple random sampling. Penelitian ini mengungkapkan hasil yang berbeda dari penelitian sebelumnya. Dari ketiga variabel independen, hanya budaya organisasi yang berpengaruh pada kinerja karyawan. Sedangkan kepuasan kerja dan motivasi tidak berpengaruh.

  1. The nationwide case-cohort study in pharmacoepidemiology: a study of iatrogenic anaphylaxis and agranulocytosis

    NARCIS (Netherlands)

    M.M. van der Klauw (Melanie)

    1997-01-01

    textabstractDrug safety is an important palt of postmarketing surveillance. In ancient times, people were already aware of the fact that drugs could have side effects. The oldest drugs were mainly of plant and animal origin, but also mercury, arsenic and antimony were used, the toxic effects of

  2. [Safety and effectiveness of pemetrexed in patients with non-small cell lung cancer in Japan - analysis of post-marketing surveillance].

    Science.gov (United States)

    Okubo, Sumiko; Kobayashi, Noriko; Taketsuna, Masanori; Kaneko, Naoya; Enatsu, Sotaro; Nishiuma, Shinichi

    2014-04-01

    The safety and effectiveness of pemetrexed(PEM)in patients with non-small cell lung cancer(NSCLC)were reviewed using data from post-marketing surveillance. Among 699 patients registered from June 2009 to May 2010, 683 patients were analyzed(343, first-line therapy: 340, second-line therapy or beyond). Patient backgrounds were as follows: median age=65 years(16.1%B75 years old); 64.7% male; 91.9% performance status 0-1; 83.2% Stage IV; 99.0% non-squamous cell cancer. Also, 86% of the first-line and 20% of the second-line cohort were receiving a concomitant anti-cancer drug(mostly platinum agents). The incidence rate of adverse drug reactions(ADR)was 76.7%, including serious cases(18.0%). The most common ADRs were decreased white blood cell count(26.8%), decreased neutrophil count(25.3%), anemia(19.2%), decreased platelet count(17.0%), and nausea(23.0%). The incidence of interstitial lung disease, which is a concern during chemotherapy, was 2.6%. Peripheral neuropathy and alopecia, events influencing a patient's quality of life, were less than 1%. The estimated median survival time was 23.2 months[95%CI: 19.8 months-not calculable]in the first-line cohort, and 11.8 months[95% CI: 10.5-13.7 months]in the B second-line cohort. The surveillance results showed no apparent difference in total ADRs in this current study compared to the safety profile established in clinical trials previously conducted in Japan and overseas. These results demonstrate the safety and effectiveness of PEM treatment for NSCLC patients in daily clinical settings.

  3. Study of Cloud Computing in HealthCare Industry

    OpenAIRE

    Reddy, G. Nikhita; Reddy, G. J. Ugander

    2014-01-01

    In Todays real world technology has become a domiant crucial component in every industry including healthcare industry. The benefits of storing electronically the records of patients have increased the productivity of patient care and easy accessibility and usage. The recent technological innovations in the health care is the invention of cloud based Technology. But many fears and security measures regarding patient records storing remotely is a concern for many in health care industry. One n...

  4. EVALUASI BEBAN FISIOLOGIS PADA INDUSTRI MANUFAKTUR (INDUSTRI PEMBUATAN KOMPONEN PESAWAT TERBANG DAN INDUSTRI SEPATU

    Directory of Open Access Journals (Sweden)

    Donny Richardo Sitohang

    2012-02-01

    Full Text Available Studi ini meneliti beban fisiologis yang dialami pekerja pada industri manufaktur, tepatnya pada industri pembuatan komponen pesawat terbang dan industri pembuatan sepatu. Pada industri pembuatan komponen pesawat terbang pekerjaan yang akan diteliti beban fisiologisnya adalah pekerjaan assembly, machining,dan metal forming. Untuk industri sepatu pekerjaan yang akan diamati adalah pekerjaan pola, jahit dan potong. Penelitian ini melibatkan 10 orang responden pada setiap jenis pekerjaan. Pada industri pembuatan komponen pesawat terbang nilai rata-rata denyut jantung kerja untuk pekerjaan assembly adalah sebesar 82.9±7,1 denyut/menit, untuk pekerjaan machining sebesar 79.9±9,5 denyut/menit, dan untuk pekerjaan metal forming sebesar 88,8 ±11,2  denyut/menit. Nilai rata-rata konsumsi oksigen relatif pada pekerjaan assembly adalah sebesar 20,8±4%, pekerjaan machining 23,1±5%, dan pekerjaan metal forming 26,4 ± 8%. Sedangkan pada industri pembuatan sepatu nilai denyut jantung kerja rata-rata untuk pekerjaan pola adalah 82±5,3 denyut/menit, pekerjaan jahit 84,5±6,1 denyut/menit, dan pekerjaan potong 88,4±11,5 denyut/menit. Nilai rata-rata konsumsi oksigen relatif pada pekerjaan pola adalah sebesar 15,8±5%, pekerjaan jahit 15,9±4%, dan pekerjaan potong 18±7%. Secara umum intensitas beban kerja fisik pada aktivitas yang diteliti baik pada industri pembuatan komponen pesawat terbang maupun industri pembuatan sepatu bersifat ringan dan masih berada dalam batas yang direkomendasikan. Kata kunci : Beban kerja fisiologis, Konsumsi Oksigen, Denyut Jantung, Skala Borg       Generally, the purpose of this study is to evaluate work physical capacity of Indonesian Aerospace production division operators and shoe industry operators. In this study, physiological workloads were evaluated in assembly, machining, and metal forming tasks (Indonesian Aerospace pattern making activity, sewing, and cutting (shoe industry using three indicators (heart rate

  5. Natural gas industry competitiveness study

    International Nuclear Information System (INIS)

    1999-09-01

    A national study on the competitiveness of the natural gas industry was undertaken by the BC Oil and Gas Commission in cooperation with, and with the encouragement of the Canadian Association of Petroleum Producers (CAPP). The objective of the study was to compare the cost competitiveness of natural gas exploration , production, gathering and processing in British Columbia to the costs of the same processes in Alberta. The study was carried out by building an 'expected case' for each gas producing area in British Columbia and Alberta by averaging past events in such specific areas as pool sizes, production profiles, loads, drilling success rates, gas compositions, land, drilling, exploration and production/gathering costs, third party production/gathering and processing fees and abandonment costs; by constructing a cash flow model for each case, calculating unit cost, and ranking cases. The report provides the details of the methodology, displays the results of the investigation in graphical form, comments on the results factoring in also labour costs and cost differences due to resource characteristics, identifies some trends such as an increase in the proportion of connections to smaller plants, and provides suggestions for improvements

  6. Entering Industry: A Case Study of Links between a School Vocational Program and the Building and Construction Industry

    Science.gov (United States)

    Taylor, Anthea

    2004-01-01

    Few studies have tracked youth transition beyond the immediate post-school period or have looked at the longer-term outcomes of post-school programs. This study reports the findings of a case study investigating links between an industry-specific school vocational education and training (VET) program and subsequent work transitions to the building…

  7. 2002 Industry Studies: Aircraft

    Science.gov (United States)

    2002-01-01

    aircraft to a defense electronics, systems integration and information technology company.39 Northrop Grumman no longer seeks a position as a prime...between the military and civil market . Though also upgrading the H-1 helicopter series for the USMC, Bell has mortgaged its future on tiltrotor technology ...business in export dollars, the industry has been forced to look for new markets as worldwide aircraft sales have dropped. Because the U.S. national

  8. Industrial relationships and nationalisation in the South Wales coalmining industry

    Energy Technology Data Exchange (ETDEWEB)

    Zweiniger-Bargielowska, I.-M. (University of Cambridge, Cambridge (United Kingdom))

    1990-01-01

    The thesis examines industrial relationships in the South Wales coal mining industry at a colliery level. Various industrial relations stereotypes in the industry and the effect of nationalization on them are examined. The study concentrates on the collieries rather than the communities, comparing four collieries. Colliery managers, underofficials and mineworkers are studied, both in themselves and in relation to each other. Insights are gained into the causes of conflict within the industry. It is concluded that the ownership of the industry is not a major determinant of the level of conflict. It is suggested that many established views on the mining work force and attitudes to nationalization, work and unions need reassessing.

  9. Study of ants as bioindicators of industrial pollution in Kemerovo Region, Russia

    Science.gov (United States)

    Blinova, S. V.; Dobrydina, T. I.

    2018-01-01

    The myrmecocomplexes of five industrial cities in the territory of Kuzbass, Russia, were studied. The general trends in the reaction of ants to the pollution by gaseous (chemical industry) and solid (coal and cement dust, lead and zinc waste and metallurgical industry) emissions were revealed. It was found out that the proportion of species of subfamilies, species richness and density of the settlement can be used as bioindicators. The predominance of L. niger and M. rubra nests in myrmecocomplexes immediately indicates a high degree of man-made impact.

  10. A case–control study of occupation/industry and renal cell carcinoma risk

    International Nuclear Information System (INIS)

    Karami, Sara; Rothman, Nathanial; Chow, Wong-Ho; Purdue, Mark P; Colt, Joanne S; Schwartz, Kendra; Davis, Faith G; Ruterbusch, Julie J; Munuo, Stella S; Wacholder, Sholom; Stewart, Patricia A; Graubard, Barry I

    2012-01-01

    The role of occupation in the etiology of renal cell carcinoma (RCC) is unclear. Here, we investigated associations between employment in specific occupations and industries and RCC, and its most common histologic subtype, clear cell RCC (ccRCC). Between 2002 and 2007, a population-based case–control study of Caucasians and African Americans (1,217 cases; 1,235 controls) was conducted within the Detroit and Chicago metropolitan areas to investigate risk factors for RCC. As part of this study, occupational histories were ascertained through in-person interviews. We computed odds ratios (ORs) and 95% confidence intervals (CIs) relating occupation and industry to RCC risk using adjusted unconditional logistic regression models. Employment in the agricultural crop production industry for five years or more was associated with RCC (OR = 3.3 [95% CI = 1.0-11.5]) and ccRCC in particular (OR = 6.3 [95% CI = 1.7-23.3], P for trend with duration of employment = 0.0050). Similarly, RCC risk was elevated for employment of five years or longer in non-managerial agricultural and related occupations (OR RCC = 2.1 [95% CI = 1.0-4.5]; OR ccRCC = 3.1 [95% CI = 1.4-6.8]). Employment in the dry-cleaning industry was also associated with elevated risk (OR RCC = 2.0 [95% CI = 0.9-4.4], P for trend = 0.093; OR ccRCC = 3.0 [95% CI = 1.2-7.4], P for trend = 0.031). Suggestive elevated associations were observed for police/public safety workers, health care workers and technicians, and employment in the electronics, auto repair, and cleaning/janitorial services industries; protective associations were suggested for many white-collar jobs including computer science and administrative occupations as well employment in the business, legislative, and education industries. Our findings provide support for an elevated risk of RCC in the agricultural and dry-cleaning industries and suggest that these associations may be stronger for the ccRCC subtype. Additional studies are needed to confirm

  11. Waste Management in Industrial Construction: Investigating Contributions from Industrial Ecology

    Directory of Open Access Journals (Sweden)

    Larissa A. R. U. Freitas

    2017-07-01

    Full Text Available The need for effective construction waste management is growing in importance, due to the increasing generation of construction waste and to its adverse impacts on the environment. However, despite the numerous studies on construction waste management, recovery of construction waste through Industrial Symbiosis and the adoption of other inter-firm practices, comprised within Industrial Ecology field of study, have not been fully explored. The present research aims to investigate Industrial Ecology contributions to waste management in industrial construction. The waste management strategies adopted in two industrial construction projects in Brazil are analyzed. The main waste streams generated are identified, recycling and landfilling diversion rates are presented and waste recovery through Industrial Symbiosis is discussed. A SWOT analysis was carried out. Results demonstrate that 9% of the waste produced in one of the projects was recovered through Industrial Symbiosis, while in the other project, waste recovery through Industrial Symbiosis achieved the rate of 30%. These data reveal Industrial Symbiosis’ potential to reduce landfilling of industrial construction wastes, contributing to waste recovery in construction. In addition, results show that industrial construction projects can benefit from the following synergies common in Industrial Ecology place-based approaches: centralized waste management service, shared waste management infrastructure and administrative simplification.

  12. INDUSTRI KREATIF INDONESIA: PENDEKATAN ANALISIS KINERJA INDUSTRI

    Directory of Open Access Journals (Sweden)

    Ahmad Kamil

    2015-10-01

    Full Text Available In 2008, the Department of Commerce of the Republic of Indonesia has launched a creative economic development documents interpreted the 2025 Indonesia became the starting point and guide the development of the creative economy in Indonesia. With the existence of this document, the industry and its stakeholders or other stakeholders can readily develop the creative economy in Indonesia. Economic development in the direction of the creative industries is one manifestation of optimism aspiration to support the Master Plan for the Acceleration and Expansion of Indonesia's Economic Development in realizing the vision of Indonesia are being developed nation. The main objective of this study is the first to analyze the role of the creative industries in Indonesia for labor, value added and productivity, secondly, to analyze the performance trend of the creative industries sector, and third, to analyze the factors affecting the performance of the creative industries sector in Indonesia. Under Indonesia Standard Industrial Classification (ISIC and codes 151-372 (manufacturing industries category identified 18 industry groups belonging to the creative industries, showed that the performance of the national creative industries has been relatively high (in terms of trend analysis of the performance of the industrial creative. Furthermore, regression analysis of panel data (econometrics indicates that company size (SIZE, wages for workers (WAGE and the content of local inputs (LOCAL has a significant impact on the performance of Indonesia's creative industry. Meanwhile, the concentration ratio (CR4 no consequences but have koresi significantly positive effect on the performance of Indonesia’s creative industry.

  13. Environmental management in Slovenian industrial enterprises - Empirical study

    Directory of Open Access Journals (Sweden)

    Vesna Čančer

    2002-01-01

    Full Text Available timulated with the firm belief that environmental management helps enterprises to achieve business success, expressed by a majority of managers in the sample enterprises, we present the results of an empirical study in the Slovene processing industry. The purpose of our research work is to identify, analyse and present the importance of the environment in business decision-making, the role of environmental management in strategic decision-making and its distribution across the business functions; environmental performance in business processes; the use of the methods for environmentally oriented business decision-making and the developmental tendencies of environmental management in Slovene enterprises of the processing industry. We define the key drivers of environmental management and their effect on the environmental behaviour of these enterprises. We present and interpret data indicating that environmental management is caused not only by compliance and regulation, but also by competition and enterprises’ own initiative.

  14. The status of wastewater management in Shokuhieh industrial park (A case study of Qom province

    Directory of Open Access Journals (Sweden)

    Mohammad Fahiminia

    2015-12-01

    Full Text Available Background: Water resource management is a strategic issue in Qom city. Water scarcity is one of the most critical concerns of industrial estates. This study aimed to evaluate wastewater management in the Shokuhieh industrial park of Qom province in 2013. Methods: This is a descriptive cross-sectional study done by visiting the industrial units in person, completing questionnaires and analyzing the results. The questionnaire had 25 questions, including general information, the status of water supply, treatment and consumption, wastewater production, reuse or discharge of produced wastewater and the status of wastewater treatment and discharge of effluent. The industrial units evaluated were active with over 50 personnel and numbered 44 in total. Results: The water suppliers in the industries included network (70.5%, network and reverse osmosis (RO (22.5%, network and tanker (2.4% and tanker (4.6%. 63.63% of the industries had water treatment systems. 19.5% reused wastewater and 31.8% performed pretreatment before discharge of wastewater. The discharge sites of water treatment units’ effluent included the absorption well (17%, greenbelt (18% and sewer (65%. Discharge sites of sanitary wastewater in 50% of the industries was sewer and in 50%, it was absorption well. The discharge sites of processed wastewater was reuse (2%, sewer (52% and absorption well (46%. Discharge sites of exiting effluent from pretreatment units in the industrial park, included sewer (85.5%, transport by tanker (7.1% and absorption well (7.1%. The type of pretreatment process in 35.7% of the industries was chemical and in 64.3%, it was septic tank. Conclusion: The results of this study showed that pre-treatment is not done in most industries and wastewater reuse is performed in few industries. The main method of wastewater disposal in industries was by discharge into the sewer and absorbent well.

  15. Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data

    International Nuclear Information System (INIS)

    Endrikat, J.; Schwenke, C.; Prince, M.R.

    2015-01-01

    Aim: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18–64 years. Materials and methods: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Results: Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. Conclusions: This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. -- Highlights: •First dedicated safety study of an extracellular contrast agent in the elderly. •Elderly patients experience fewer non-serious ADRs than younger adults. •Gadobutrol has a favourable safety profile in both age groups

  16. 1997 ACEEE summer study on energy efficiency in industry: Proceedings, refereed papers, and summary monographs

    International Nuclear Information System (INIS)

    1997-01-01

    The theme of this conference is: How industry will procure energy efficiency services in the 21st century. This theme was chose in response to the changing nature of energy service companies. These changes will bring about enhanced opportunities for alliance and partnerships in the procurement of energy efficiency services as well as energy supply services. This Summer Study provides an opportunity to explore the opportunities provided by these changes in a marketplace and examines ways in which they can be used to enhance, in a cost-effective manner, energy efficiency and productivity in industry. The refereed papers in this conference are divided into the following topics: Food Products; Chemicals and Related Products; Iron and Steel; International Energy Issues; Electric Motor Systems; Small Industries; Energy Efficiency and Pollution Prevention; Utility Industry Changes; Development of Partnerships; Case Studies; Steam Systems; Industrial Decision Making; and Industrial Energy Efficiency. The summary monographs cover: Electric Motor Systems; Energy Trends and Analysis; Small Industries; Energy Efficiency and Pollution Prevention; Utility Industry Changes; Steam Systems; Industrial Decision Making; and Display-Summary Monograph. Separate abstracts were prepared for all 55 papers

  17. Feasibility studies on cogeneration from industrial wood-processing residues in Ghana

    International Nuclear Information System (INIS)

    Brew-Hammond, A.; Atakora, S.B.

    1999-01-01

    Several feasibility studies have been undertaken on cogeneration from wood-processing industrial residues in Ghana; practically all concluded that it was not economically viable because of the low tariffs for electricity in Ghana (around 3.5 US cents per kWh) at the time. Tariffs have more than doubled since September 1998 and average tariffs for industrial consumers are now around 7-8 US cents/kWh. This paper reviews earlier studies and undertakes a sensitivity analysis to determine effects of the new tariff regime and the investment costs for co-generation projects. More detailed technical and economic feasibility studies are needed to prepare the ground for an investment programme in cogeneration from wood residues. (author)

  18. Transparent collaboration between industry and academia can serve unmet patient need and contribute to reproductive public health.

    Science.gov (United States)

    D'Hooghe, Thomas

    2017-08-01

    The pharmaceutical and device industry has greatly contributed to diagnostic and therapeutic approaches in reproductive medicine in a very highly regulated environment, ensuring that development and manufacturing follow the highest standards. In spite of these achievements, collaboration between industry and physicians/academia is often presented in a negative context. However, today more than ever, partnership between industry and academia is needed to shorten the timeline between innovation and application, and to achieve faster access to better diagnostics, drugs and devices for the benefit of patients and society, based on complementary knowledge, skills and expertise. Such partnerships can include joined preclinical/clinical and post-marketing research and development, joint intellectual property, and joint revenue. In Europe, the transparency of this collaboration between pharmaceutical industry and medical doctors has been made possible by the Compliance and Disclosure Policy published by the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the major pharmaceutical companies operating in Europe, and includes as members some but not all companies active in infertility and women's health. Under the EFPIA Disclosure Code of conduct, companies need to disclose transfers of value including amounts, activity type and the names of the recipient Health Care Professionals and Organizations. EFPIA member companies have also implemented very strict internal quality control processes and procedures in the design, statistical analysis, reporting, publication and communication of clinical research, according to Good Clinical Practice and other regulations, and are regularly inspected by competent authorities such as the US Food and Drug Administration (FDA) or European Medicines Agency (EMA) for all trials used in marketing authorization applications. The risk of scientific bias exists not only in the pharmaceutical industry but

  19. Laboratory scale studies on removal of chromium from industrial wastes.

    Science.gov (United States)

    Baig, M A; Mir, Mohsin; Murtaza, Shazad; Bhatti, Zafar I

    2003-05-01

    Chromium being one of the major toxic pollutants is discharged from electroplating and chrome tanning processes and is also found in the effluents of dyes, paint pigments, manufacturing units etc. Chromium exists in aqueous systems in both trivalent (Cr(3+)) and hexavalent (Cr(6+)) forms. The hexavalent form is carcinogenic and toxic to aquatic life, whereas Cr(3+) is however comparatively less toxic. This study was undertaken to investigate the total chromium removal from industrial effluents by chemical means in order to achieve the Pakistan NEQS level of 1 mg/L by the methods of reduction and precipitation. The study was conducted in four phases. In phase I, the optimum pH and cost effective reducing agent among the four popular commercial chemicals was selected. As a result, pH of 2 was found to be most suitable and sodium meta bisulfate was found to be the most cost effective reducing agent respectively. Phase II showed that lower dose of sodium meta bisulfate was sufficient to obtain 100% efficiency in reducing Cr(6+) to Cr(3+), and it was noted that reaction time had no significance in the whole process. A design curve for reduction process was established which can act as a tool for treatment of industrial effluents. Phase III studies indicated the best pH was 8.5 for precipitation of Cr(3+) to chromium hydroxide by using lime. An efficiency of 100% was achievable and a settling time of 30 minutes produced clear effluent. Finally in Phase IV actual waste samples from chrome tanning and electroplating industries, when precipitated at pH of 12 gave 100% efficiency at a settling time of 30 minutes and confined that chemical means of reduction and precipitation is a feasible and viable solution for treating chromium wastes from industries.

  20. Number of patients studied prior to approval of new medicines

    DEFF Research Database (Denmark)

    Duijnhoven, Ruben G; Straus, Sabine M J M; Raine, June M

    2013-01-01

    length of time), whereas 67 (79.8%) of the medicines met the criteria for 12-mo patient exposure (at least 100 participants studied for 12 mo). CONCLUSIONS: For medicines intended for chronic use, the number of patients studied before marketing is insufficient to evaluate safety and long-term efficacy....... Both safety and efficacy require continued study after approval. New epidemiologic tools and legislative actions necessitate a review of the requirements for the number of patients studied prior to approval, particularly for chronic use, and adequate use of post-marketing studies. Please see later...

  1. Long term energy and materials strategies for reduction of industrial CO2 emissions. A case study for the iron and steel industry

    International Nuclear Information System (INIS)

    Gielen, D.J.

    1997-01-01

    Greenhouse gas emissions emerged in the last decade as a key environmental problem on the political agenda. The most important greenhouse gas is carbon dioxide (CO 2 ). This gas results from the combustion of fossil fuels (natural gas, oil and coal). As a consequence, greenhouse gas emission reduction is closely related to energy policies. Even a stabilization of the atmospheric CO 2 concentrations at a level of 750 ppm (parts per million), more than twice the current level, implies a reduction of global emissions by 50% in the next century. The world population will simultaneously double and the capita energy consumption will increase. As a consequence, the Western industrialized countries will have to reduce their per capita emissions by more than a factor four. Such a policy goal will significantly affect the future industrial production structure. Approximately 4% of the global CO 2 emissions can be attributed to the production of iron and steel. This sector is the most important industrial source of CO 2 . The case study for the iron and steel industry will be discussed in this paper in order to illustrate the impact of significant CO 2 emission mitigation on the industry. The goal is to show the consequences of CO 2 policies for R and D planning and investment decisions. The notion that the iron and steel industry will be affected by CO 2 policies is not new; a number of studies have addressed this issue before. These studies have compared steel production technologies and emission reduction options within the iron and steel production sector. In this paper, the emission reduction in the iron and steel industry is analyzed within the framework of the changing (inter-)national energy and materials system configuration. This includes all production, conversion and consumption processes. The impact of CO 2 policies on the optimal choice of steel production technologies and on the competitiveness of steel compared to other materials will be discussed. This paper

  2. Uncovering opportunity of low-carbon city promotion with industrial system innovation: Case study on industrial symbiosis projects in China

    International Nuclear Information System (INIS)

    Dong, Liang; Gu, Fumei; Fujita, Tsuyoshi; Hayashi, Yoshitsugu; Gao, Jie

    2014-01-01

    There is a dilemma for rapid industrializing China to balance economic growth and low carbonization. Industrial symbiosis (IS) provides a system innovation to utilize the industry to fight climate change and pursue sustainable urban development, while few attentions are paid in literatures. Under this circumstance, this study reviews the low-carbon city practice in China and conducts a case study to calculate the CO 2 emissions reduction potential under promoting IS projects in two cities of China, named Jinan and Liuzhou. With the real national project in Jinan as advanced example, new scenarios related to IS are designed for Liuzhou, including comprehensive energy network, waste plastics recycling, scrap tires recycling and flying ash recycling. The material/waste and energy exchange is quantified in the IS network, as well as the related environmental benefit. The material/energy exchange is over 10 million ton and 20 thousands tce in Jinan's case, and 2.5 million ton and 45 thousand tce in Liuzhou's case. Results highlight that IS could effectively reduce CO 2 emissions. The total reduction potential amounts to 3944.05 thousands tCO 2 /year and 2347.88 thousands tCO 2 /year in Jinan and Liuzhou. Finally, policy implications on the ever-improvement of industrial symbiosis and China's sustainable urban development are proposed and discussed. - Highlights: • Investigate two real industrial symbiosis projects in Jinan and Liuzhou of China. • Quantify the material exchange and the CO 2 reduction potential of the IS network. • CO 2 reduction potential is 3944.05 and 2347.88 ktCO 2 /year in Jinan and Liuzhou. • In current China, IS is main in term of material symbiosis. • How to coordinate IS and low-carbon city is discussed

  3. An empirical study on absenteeism in Garment industry

    OpenAIRE

    T. S. Nanjundeswaraswamy

    2016-01-01

    bsenteeism is a major challenge for any organization in the current competitive world. Curbing absenteeism helps organizations achieve their targets and increases productivity. This study highlights the major causes of absenteeism in the production division of a garment industry under various dimensions, which influence on absenteeism like work environment, organizational culture, relation and co-operation, compensation and rewards, facilities, job satisfactory and security, and general facto...

  4. Motor carrier industry profile study : financial and operating performance profiles by industry segment, 2001-2002.

    Science.gov (United States)

    2004-09-01

    This report profiles the motor carrier industry and its significant operating segments. It is one of a series of reports analyzing various aspects of the motor carrier industry. Other reports in the series focus on the safety performance of the indus...

  5. Sudbury soils study : industry perspective

    International Nuclear Information System (INIS)

    Watson, G.

    2009-01-01

    This presentation presented the industry perspective of a soils study conducted by Vale Inco to assess the risk of mining activities in the Sudbury region to human health and the environment. The study was comprised of extensive soil collection and analysis; a review of historical soils data; and extensive human health and ecological risk assessments. Extensive sampling was also conducted on air, dust, and locally-produced foods. The human health risk assessment (HHRA) study was conducted and administered by a multi-stakeholder technical committee attended by the public. A public advisory committee was also formed by Vale Inco to disseminate scientific information to the community. Scientific data obtained in the study were also peer-reviewed by an independent expert review panel comprised of leading specialists in human health, toxicology, speciation, and risk assessment. The study showed that the identified risks were over-estimated in the interest of protecting human health. The study demonstrated to the mining company that multi-stakeholder risk assessments with community involvement are expensive and time-consuming. Risk assessment methods and standard practices are conservative, and may determine risks that aren't always attributable to the proponent. It was concluded that risk assessment progress and results must be clearly and frequently communicated with the public. The presentation emphasized that companies must take time to listen to the public and consider the priorities of communities in the region. tabs., figs

  6. Assessment of industrial liquid waste management in Omdurman Industrial Area

    International Nuclear Information System (INIS)

    Elnasri, R. A. A.

    2003-04-01

    This study was conducted mainly to investigate the effects of industrial liquid waste on the environment in the Omdurman area. Various types of industries are found around Omdurman. According to the ISC the major industries are divided into eight major sub-sectors, each sub-sector is divided into types of industries. Special consideration was given to the liquid waste because of its effects. In addition to the available data, personal observation supported by photographs, laboratory analyses were carried on the industrial effluents. The investigated parameters in the analysis were, BOD, COD, O and G, Cr, TDS, TSS, pH, temp and conductivity. Interviews were conducted with waste handling workers in the industries, in order to assess the effects of industrial pollution. The results obtained showed that pollutants produced by all the factories were found to exceed the accepted levels of the industrial pollution control. The effluents disposed of in the sites allotted by municipal authorities have adverse effects on the surrounding environment and public health and amenities. Accordingly the study recommends that the waste water must be pretreated before being disposed of in site allotted by municipal authorities. Develop an appropriate system for industrial waste proper management. The study established the need to construct a sewage system in the area in order to minimize the pollutants from effluents. (Author)

  7. Assessment of industrial liquid waste management in Omdurman Industrial Area

    Energy Technology Data Exchange (ETDEWEB)

    Elnasri, R A. A. [Institute of Environmental Studies, University of Khartoum, Khartoum (Sudan)

    2003-04-15

    This study was conducted mainly to investigate the effects of industrial liquid waste on the environment in the Omdurman area. Various types of industries are found around Omdurman. According to the ISC the major industries are divided into eight major sub-sectors, each sub-sector is divided into types of industries. Special consideration was given to the liquid waste because of its effects. In addition to the available data, personal observation supported by photographs, laboratory analyses were carried on the industrial effluents. The investigated parameters in the analysis were, BOD, COD, O and G, Cr, TDS, TSS, pH, temp and conductivity. Interviews were conducted with waste handling workers in the industries, in order to assess the effects of industrial pollution. The results obtained showed that pollutants produced by all the factories were found to exceed the accepted levels of the industrial pollution control. The effluents disposed of in the sites allotted by municipal authorities have adverse effects on the surrounding environment and public health and amenities. Accordingly the study recommends that the waste water must be pretreated before being disposed of in site allotted by municipal authorities. Develop an appropriate system for industrial waste proper management. The study established the need to construct a sewage system in the area in order to minimize the pollutants from effluents. (Author)

  8. STUDI PENERAPAN PRODUKSI BERSIH UNTUK INDUSTRI KERUPUK

    Directory of Open Access Journals (Sweden)

    Banun Diyah Probowati

    2016-11-01

    Full Text Available Cleaner productionwas minimize waste and emissions and maximize product output. The aimed of research were to identified and to analysed application of cleaner production from crackers industry. By analysing the flow of materials and energy in this industry and then to identify options to minimize waste industrial processes. Improvements of organisation and technology help to reduce or suggest better choices in use of materials and energy, and to avoid waste, waste water generation, and gaseous emissions, and also waste heat.. Application of this cleaner production were a good house keeping, recycle, reduce and reuse. Modified a fireplace and smoked funnel were the choice of alternative to application the cleaner production. The benefit from application of cleaner production was 5% efficiency wood to be burn. There was the complete process of burning with value of efficiency.

  9. Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report).

    Science.gov (United States)

    Takahashi, Tomohiko; Hayata, Satoru; Kobayashi, Akihiro; Onaka, Yuna; Ebihara, Takeshi; Hara, Terufumi

    2018-03-01

    Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. PAH patients aged 15 years or older were subjected to the analysis. The safety analysis by overall cases or stratification of patient backgrounds and the efficacy analysis were investigated. Regarding patient characteristics, the 702 patients subjected to safety analysis included 543 (77.4%) women and 546 (77.8%) patients at WHO functional class II/III. The mean observational time was 392.7 days. A total of 324 adverse drug reaction (ADR) occurred in 204 (29.1%) patients. Common ADRs (≥ 2%) included anemia (4.6%), peripheral edema (4.1%), headache (3.6%), edema and face edema (2.6% each), abnormal hepatic function (2.3%), and epistaxis (2.1%). There were 82 serious ADRs occurring in 44 (6.3%) patients (385 serious adverse events in 184 (26.2%) patients). Although 11 (1.6%) interstitial lung disease (ILD) cases were reported, all were observed in patients with disease that may contribute to ILD and therefore it is difficult to assess if ambrisentan was associated with these events. There was no difference in safety in relation to the presence/absence of connective tissue disease-related PAH (CTD-PAH) or combination therapy. Among 677 patients subjected to efficacy analysis, those in whom hemodynamic status was determined before and after treatment showed improvement in the mean pulmonary arterial pressure and pulmonary vascular resistance after treatment. The interim results showed safety consistent with the known profile of ambrisentan in terms of the types and frequencies of ADRs in patients with PAH in real clinical practice, in comparison with

  10. Industrial Organization and Human Resource Management in Thailand : A Case Study of Telecommunications Industry

    OpenAIRE

    Osatis, Chadatan

    2017-01-01

    Over the past two decades, information, computer and communications have played an increasingly greater role in the Thai economy. The development of the telecommunications industry, particular the internet, broadband networks, mobile applications, IT services, software and hardware, has laid the solid foundations of an integrated platform to facilitate economic and social interactions in modern societies. In this regard, the Thai telecommunications industry has been undergoing significant eco...

  11. The analysis and investigation on basic data for development status study on the radioisotope industry

    International Nuclear Information System (INIS)

    Kim, In Hwan; Shim, H. S.; Chun, I. Y.; Jang, J. H.

    2005-12-01

    This study is intended to investigate and analysis the use degree of the radioisotope in domestic industry by the data of indirect information in focus of industry using the radioisotope per year basis. The contents and scope of this study is as follows: - Review of the industry sorting methods and application of the UNIDO(United Nation Industry Development organization). - Investigation of RI permitted companies and notified companies by 2003. 12. 31. - The Analysis and investigation of the basic data for the number of workers, wages and salaries of employees, product costs and the value added etc. of RI permitted companies from 1980

  12. A case–control study of occupation/industry and renal cell carcinoma risk

    Directory of Open Access Journals (Sweden)

    Karami Sara

    2012-08-01

    Full Text Available Abstract Background The role of occupation in the etiology of renal cell carcinoma (RCC is unclear. Here, we investigated associations between employment in specific occupations and industries and RCC, and its most common histologic subtype, clear cell RCC (ccRCC. Methods Between 2002 and 2007, a population-based case–control study of Caucasians and African Americans (1,217 cases; 1,235 controls was conducted within the Detroit and Chicago metropolitan areas to investigate risk factors for RCC. As part of this study, occupational histories were ascertained through in-person interviews. We computed odds ratios (ORs and 95% confidence intervals (CIs relating occupation and industry to RCC risk using adjusted unconditional logistic regression models. Results Employment in the agricultural crop production industry for five years or more was associated with RCC (OR = 3.3 [95% CI = 1.0-11.5] and ccRCC in particular (OR = 6.3 [95% CI = 1.7-23.3], P for trend with duration of employment = 0.0050. Similarly, RCC risk was elevated for employment of five years or longer in non-managerial agricultural and related occupations (ORRCC = 2.1 [95% CI = 1.0-4.5]; ORccRCC = 3.1 [95% CI = 1.4-6.8]. Employment in the dry-cleaning industry was also associated with elevated risk (ORRCC = 2.0 [95% CI = 0.9-4.4], P for trend = 0.093; ORccRCC = 3.0 [95% CI = 1.2-7.4], P for trend = 0.031. Suggestive elevated associations were observed for police/public safety workers, health care workers and technicians, and employment in the electronics, auto repair, and cleaning/janitorial services industries; protective associations were suggested for many white-collar jobs including computer science and administrative occupations as well employment in the business, legislative, and education industries. Conclusions Our findings provide support for an elevated risk of RCC in the agricultural and dry-cleaning industries and

  13. An empirical study of business effect and industry effect in Galicia

    Directory of Open Access Journals (Sweden)

    Susana Iglesias

    2007-07-01

    Full Text Available This work is a contribution to the analysis of the influence that industry and business factors have on the variability of the organizational performance. A linear hierarchical model with fixed effects is applied to a sample of Galician firms. The results show that the portion of such variability explained by the business factor is clearly greater than that explained by the industry factor. These results, in favour of the business effect, are similar to other obtained in previous empirical studies.

  14. DAMPAK HUBUNGAN INDUSTRIAL YANG BERSIFAT KAPITALISTIK TERHADAP HARMONISASI HUBUNGAN INDUSTRIAL PENGUSAHA DENGAN PEKERJA (Studi Kasus di PT Fiscous South Pacifik Kabupaten Purwakarta

    Directory of Open Access Journals (Sweden)

    H Gunarto

    2011-03-01

    Full Text Available The implementation of the concept on freedom of rights for association of trade union is facing the phenomenon of liberal capitalistic global economic trends characterized by conflicting industrial relations. The problems  in this research, What are the impacts of the implementation of the concept on freedom  for association in trade unions to industrial relations which is capitalistic to the workers’ welfare?. To answer these three problems, the writer used qualitative analysis with constructivism paradigm. This study draws some conclusions as follows, the implementation of the concept on freedom for association in trade unions, which is capitalistic, affects the following: (1 the high rates on labor strike, (2 the increasing number of disputes on industrial relations between the entrepreneurs and the workers.   Keywords: impact, industrial relations, capitalism

  15. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Science.gov (United States)

    2012-02-21

    ... industry entitled ``Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and... data analysis in the context of identifying potential drug interactions. The guidance also addresses... Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling.'' Comments were received...

  16. A framework for studying the importance of open innovation in the maritime industry

    DEFF Research Database (Denmark)

    Perunovic, Zoran; Vidic-Perunovic, Jelena

    The industry leaders require from maritime organizations to open up their innovation processes. The question is if the industry is ready for that? In this paper we theorize about that possibility and develop a framework for studying the importance and relevance of open innovation for the maritime...

  17. A Qualitative Study of the European Trucking Industry and Logistics Strategies Using the United States Motor Carrier Industry as a Guide

    Science.gov (United States)

    1992-09-01

    interpretation of the data (Rommerskirchen, 1986:14). In addition to tax differences, the basic costs of operations vary among EC-member states. License fees...aggregation impossible" (Aberle, 1985:18). 4. "Not only are special statistics on nationally specific transport expenditure incomplete, but even the basic ...industry. Various studies concluded that the trucking industry’s collective ratemaking system, composed of regional rate bureaus, resulted in rates in the

  18. Industry evolution in developing countries : the Indonesian pulp and paper industry

    NARCIS (Netherlands)

    Dijk, van M.

    2003-01-01

    Almost all empirical research on industry evolution has been conducted on high or medium technology industries in industrialised countries. In this paper, a detailed analysis of the life cycle of Indonesia's pulp and paper industry is presented as case study to investigate industry evolution in

  19. More evidence of unpublished industry studies of lead smelter/refinery workers

    Science.gov (United States)

    2015-01-01

    Background Lead smelter/refinery workers in the US have had significant exposure to lead and are an important occupational group to study to understand the health effects of chronic lead exposure in adults. Recent research found evidence that studies of lead smelter/refinery workers have been conducted but not published. This paper presents further evidence for this contention. Objectives To present further evidence of industry conducted, unpublished epidemiologic studies of lead smelter/refinery workers and health outcomes. Methods Historical research relying on primary sources such as internal industry documents and published studies. Results ASARCO smelter/refinery workers were studied in the early 1980s and found to have increased risk of lung cancer and stroke in one study, but not in another. Conclusions Because occupational lead exposure is an on-going concern for US and overseas workers, all epidemiologic studies should be made available to evaluate and update occupational health and safety standards. PMID:26070220

  20. Post-marketing access to orphan drugs: a critical analysis of health technology assessment and reimbursement decision-making considerations

    Directory of Open Access Journals (Sweden)

    Iskrov G

    2014-01-01

    Full Text Available Georgi Iskrov, Rumen Stefanov Department of Social Medicine and Public Health, Medical University of Plovdiv, Plovdiv, Bulgaria Abstract: This study aims to explore the current rationale of post-marketing access to orphan drugs. As access to orphan medicinal products depends on assessment and appraisal by health authorities, this article is focused on health technology assessment (HTA and reimbursement decision-making considerations for orphan drugs. A critical analysis may identify important factors that could predetermine the combined outcomes of these two processes. Following this objective, an analytical framework was developed, comprising three overlaying issues: to outline what is currently done and what needs to be done in the field of HTA of orphan drugs, to synthesize important variables relevant to the reimbursement decision-making about orphan drugs, and to unveil relationships between theory and practice. Methods for economic evaluation, cost-effectiveness threshold, budget impact, uncertainty of evidence, criteria in reimbursement decision-making, and HTA research agenda are all explored and discussed from an orphan drug perspective. Reimbursement decision-making for orphan drugs is a debate of policy priorities, health system specifics, and societal attitudes. Health authorities need to pursue a multidisciplinary analysis on a range of criteria, ensuring an explicit understanding of the trade-offs for decisions related to eligibility for reimbursement. The only reasonable way to accept a higher valuation of orphan drug benefits is if these are demonstrated empirically. Rarity means that the quality of orphan drug evidence is not the same as for conventional therapies. Closing this gap is another crucial point for the timely access to these products. The generation of evidence goes far beyond pre-market authorization trials and requires transnational cooperation and coordination. Early constructive dialogue among orphan drug

  1. A Study on the Korea Database Industry Promotion Act Legislation

    Directory of Open Access Journals (Sweden)

    Bae, Seoung-Hun

    2013-09-01

    Full Text Available The Database Industry Promotion Act was proposed at the National Assembly plenary session on July 26, 2012 and since then it has been in the process of enactment in consultation with all the governmental departments concerned. The recent trend of economic globalization and smart device innovation suggests a new opportunity and challenges for all industries. The database industry is also facing a new phase in an era of smart innovation. Korea is in a moment of opportunity to take an innovative approach to promoting the database industry. Korea should set up a national policy to promote the database industry for citizens, government, and research institutions, as well as enterprises. Above all, the Database Industry Promotion Act could play a great role in promoting the social infrastructure to enhance the capacity of small and medium-sized enterprises. This article discusses the background of the development of the Database Industry Promotion Act and its legislative processes in order to clarify its legal characteristics, including the meaning of the act. In addition, this article explains individual items related to the overall structure of the Database Industry Promotion Act. Finally, this article reviews the economic effects of the database industry for now and the future.

  2. ICAF Financial Services Industry Study

    Science.gov (United States)

    2005-06-01

    Mishkin , Frederic S. and Stanley G. Eakins. Financial Markets + Institutions . Boston, MA: Addison Wesley. 2003... Financial Markets , Federal Reserve Bank of New York, 1998. Mishkin , Frederic S. and Eakins, Stanley G., Financial Markets + Institutions , Fourth...discussion of the industry would be complete without an understanding of the concept of moral hazard in the financial markets . According to Mishkin

  3. Case study: centralized wastewater treatment plant at Rawang Integrated Industrial Park

    International Nuclear Information System (INIS)

    Ting Teo Ming; Khomsaton Abu Bakar; Zulkafli Ghazali; Khairul Zaman Mohd Dahlan

    2006-01-01

    Survey has been conducted at Rawang Integrated Industrial Park (RIIP) to investigate the possibility of setting up centralized industrial wastewater treatment plant. Rawang integrated industrial park is selected based on suggestion from department of environment. RIIP consists of about 150 industries with various type of activities operated in the area. Only 9 out of estimated 150 industries have individual wastewater treatment plant. The business activities of the 9 industries include food processing, textile, welding rods manufacturing, steel galvanizing and battery manufacturing. Wastewater generated by the industries are characterized by high oil and grease, cod, bod, organic matter, metal hydroxide and acidic. Besides that most of industries do the monitoring only once a month. This paper will also discuss the advantages of setting up of centralized industrial wastewater treatment plant to the government authorities, industries, people and environment. (Author)

  4. Studying the pollution of Barada river environment with poisonous elements resulting from leather industry (i.e. tanning industry)

    International Nuclear Information System (INIS)

    Khamis, I.; Al-Masri, M.S.; Sarheel, A.; Al-Somel, N.

    2000-07-01

    The impact of tanning and electroplating industry on the eastern part of Barada river environment has been evaluated. Sediment, soil and plant samples were collected from nine sites at the river near the eastern industrial complex during 1999. Results of instrumental neutron activation analysis have shown high levels of chrome in sediment collected near the tanning factories; the highest value obtained being 2692 ppm. In addition, relatively high levels of Cr were also found in the agriculture soil collected near the riverbank in the industrial complex; Cr concentrations in plant leaves grown at riverbank were found low and this due strong bounding of Cr to soil. Other trace metals such as copper was about 4000 ppm, which is much higher than the natural levels; electroplating shops are the main source of this element in the area. Furthermore, concentrations of the studied trace metals have decreased as the elements were found to be at low concentrations, but the obtained data can be used as a baseline for future monitoring. (Author)

  5. Summary of experimental studies on biological effects of radionuclides in Chinese Nuclear Industry

    International Nuclear Information System (INIS)

    Chen Rusong

    1994-11-01

    The experimental studies on the biological effects with internal contamination of radionuclides (Such as Uranium, Plutonium, Tritium, Iodine, Radon and its products, etc.) in the Chinese nuclear industry were summarized systematically. In these studies some institutes in the nuclear industry system and other relevant units in China were involved. The review was carried out in both stochastic and deterministic effects, and focused on the dose-effect relationship. The research work showed that great progress for the experimental studies on biological effects with internal irradiation has been made in China. There is a definite characteristic in a certain extent. It makes contribution to develop the production of nuclear industry and the construction of national economy. Several constructive suggestions of prospects for the work in future were proposed and it will make an attention in the field of radiation protection at home and abroad

  6. Perceptions of Private Sector towards the Pollutant Release and Transfer Register: A Case Study on Petrochemical Industry in the Map Ta Phut Industrial Estate, Rayong, Thailand

    Directory of Open Access Journals (Sweden)

    Marie Kondo

    2013-01-01

    Full Text Available Under the Rio Declaration and Agenda 21 from the United Nations Conference on Environment and Development in 1992 as well as other international agreements, Thailand is currently in the process of adopting the Pollutant Release and Transfer Register (PRTR through a pilot project in Rayong province with assistance from the Japan International Cooperation Agency (JICA. This research aimed to study perceptions of private sector towards the PRTR through a case study on petrochemical industry in the Map Ta Phut Industrial Estate. Through semi-structured questionnaires and in-depth interviews, the study found that the petrochemical industry viewed that benefits of the PRTR for the government and civil society is quite clear, while each petrochemical company has different understanding on such benefit for private sector to be as sustainable industrial management. Various incentive measures and concerns on the PRTR were also indicated in this study.

  7. Institutional arrangements in the emerging biodiesel industry: Case studies from Minas Gerais—Brazil

    International Nuclear Information System (INIS)

    Watanabe, Kassia; Bijman, Jos; Slingerland, Maja

    2012-01-01

    Connecting (small) family farmers to the emerging biodiesel industry requires careful design of the institutional arrangements between the producers of oil crops and the processing companies. According to institutional economics theory, the design of effective and efficient arrangements depends on production and transaction characteristics, the institutional environment, and the organizational environment supporting the transaction between producers and the industry. This paper presents a comparative study on two cases in the feedstock-for-biodiesel industry in the state of Minas Gerais, Brazil. The two case studies represent the production and transaction system of soybeans (Glycine max L. Merrill) and castor beans (Ricinus communis L.). Important elements of effective and efficient institutional arrangements are farmer collective action, availability of technical and financial support, and farmer experience with particular crops. - Highlights: ► We study institutional arrangements for feedstock transactions between family farmers and the biodiesel industry. ► We focussed on soybean and castor bean production and transaction systems. ► Institutional arrangements are affected by product and production characteristics. ► They are also affected by collective actions organizations such as cooperatives. ► Soybean involves lower transaction costs and therefore more simple arrangement than castor bean.

  8. Scenario Study on PM emission Reduction in Cement Industry

    Science.gov (United States)

    Tang, Qian; Chen, Xiaojun; Xia, Xin; Wang, Lijuan; Wang, Huili; Jin, Ling; Yan, Zhen

    2018-01-01

    Cement industry is one of the high pollution industries in China. Evaluation of the primary particulate matter (PM) emission status and the reduction potential is not only important for our understanding of the effectiveness of current pollution control measures but also vital for future policy design. In this study, PM emitted from cement producing process in 2014 was calculated using an emission factor method. Three PM emission control scenarios were set up considering source control, process management and end-of-pipe treatment, and the PM emission reduction by 2020 under the three scenarios was predicted, respectively. In 2014, the primary PM emission from cement industry was 1.95 million tons. By 2020, the productions of cement and clinker were expected to increase by 12% and 7%, respectively, and the PM emission would increase by about 10%. By implementation of GB4915-2013 and comprehensive control of fugitive PM emission, the PM emission would probably be reduced by 34%. Another 7% decrease would be expected from source control. The second scenario can be considered as an assessment of the effectiveness of the revised emission standard, and this research can be used as a technical support to the environmental management authorities to make relevant policies.

  9. Waste Management in Industrial Construction: Investigating Contributions from Industrial Ecology

    OpenAIRE

    Larissa A. R. U. Freitas; Alessandra Magrini

    2017-01-01

    The need for effective construction waste management is growing in importance, due to the increasing generation of construction waste and to its adverse impacts on the environment. However, despite the numerous studies on construction waste management, recovery of construction waste through Industrial Symbiosis and the adoption of other inter-firm practices, comprised within Industrial Ecology field of study, have not been fully explored. The present research aims to investigate Industrial Ec...

  10. Re-evaluation of the definition of remission on the 17-item Hamilton Depression Rating Scale based on recovery in health-related quality of life in an observational post-marketing study.

    Science.gov (United States)

    Sawamura, Jitsuki; Ishigooka, Jun; Nishimura, Katsuji

    2018-01-16

    Although a score of less than 7 for the 17-item Hamilton Depression Rating Scale (HAM-D17) has been widely adopted to define remission of depression, a full recovery from depression is closely related to the patient's quality of life as well. Accordingly, we re-evaluated this definition of remission using HAM-D17 in comparison with the corresponding score for health-related quality of life (HRQOL) measured by the SF-36. Using the data for depressive patients reported by GlaxoSmithKline K.K. (Study No. BRL29060A/863) in a post-marketing observational study of paroxetine, with a sample size of n = 722, multivariate logistic regression was performed with the HAM-D17 score as a dependent variable and with each of the eight domain scores of HRQOL (from the SF-36) transformed into a binominal form according to the national standard value for Japan. Then, area under curve of receiver operating characteristic analyses were conducted. Based on the obtained results, a multivariate analysis was performed using the HAM-D17 score in a binomial form with HAM-D17 as a dependent variable and with each of the eight HRQOL domain scores (SF-36) as binominalized independent variables. A cutoff value for the HAM-D17 score of 5 provided the maximum ROC-AUC at "0.864." The significantly associated scores of the eight HRQOL domains (SF-36) were identified for the HAM-D17 cutoff values of ≥5 and ≤4. The scores for physical functioning (odds ratio, 0.473), bodily pain (0.557), vitality (0.379), social functioning (0.540), role-emotion (0.265), and mental health (0.467) had a significant negative association with the HAM-D17 score (p < 0.05), and HRQOL domain scores for HAM-D17 ≥ 5 were significantly lower compared with those for HAM-D17 ≤ 4. A cutoff value for HAM-D17 of less than or equal to 4 was the best candidate for indicating remission of depression when the recovery of HRQOL is considered. Restoration of social function and performance should be considered

  11. Environmental impact of industrial wastes on marine area, case study: Port Sudan coastal area

    International Nuclear Information System (INIS)

    Abdalrahman, E. A. H.

    2004-05-01

    This study was carried out to determine the effect of the industrial wastes on marine environment in Port Sudan area. A very intensive study has been made to identify types of pollutions drained in seawater at study area of Red Sea coast. Samples were taken from three stations (1, 2 and 3) at study area and the following analysis were made: Temperature, salinity, hydrogen ion concentration, dissolved oxygen, biochemical oxygen demand, nutrient, oil and grease. The laboratory results revealed that wastes pollute the marine environment as the cooling water from studied industries which is drain into the seawater increases the degree of temperature approximately from 6 to 12 C degree above the allowed rate, the matter which was adverse effect on the environment and living marine creatures due to the sudden change of temperature degree. Also, it was found that the great amount of oil spills discharged into seawater due to many factors such as: cooling water, oil spills from ships and loading and discharging operations of crude oil ships. Accordingly these oils spills might have a deadly effect on living marine creatures, which have been mention in details through out this research. Hence, and to minimize this adverse effect of industrial wastes and others on the marine environment, may recommend to the following: Pretreatment to the industrial wastes should be taking before its draining into the Red Sea coastal area. Surveillance all ships into the port and observing loading and discharging operations as well as those ships in the regional waters and implementing the international maritime laws. Enlightenment the industrial administrators and manpower working with them about the severity which will definitely cause the marine environmental deterioration as a result of industrial wastes. To punish every one who violates the laws of environment protection. Thus, can be safeguarding the environment from pollutions and consequently develop the natural resources and proceed

  12. Evaluating Electronic Customer Relationship Management Performance: Case Studies from Persian Automotive and Computer Industry

    OpenAIRE

    Safari, Narges; Safari, Fariba; Olesen, Karin; Shahmehr, Fatemeh

    2016-01-01

    This research paper investigates the influence of industry on electronic customer relationship management (e-CRM) performance. A case study approach with two cases was applied to evaluate the influence of e-CRM on customer behavioral and attitudinal loyalty along with customer pyramid. The cases covered two industries consisting of computer and automotive industries. For investigating customer behavioral loyalty and customer pyramid companies database were computed while for examining custome...

  13. Association of Parkinson's disease with industry sectors: a French nationwide incidence study.

    Science.gov (United States)

    Vlaar, Tim; Kab, Sofiane; Schwaab, Yannick; Fréry, Nadine; Elbaz, Alexis; Moisan, Frédéric

    2018-05-05

    In order to identify working environments at risk for Parkinson's disease (PD), we investigated the relation between the importance of industry sectors, used as a surrogate for occupational exposures, and PD incidence in French cantons. The number of incident PD cases (2010-2014) in 3689 cantons of metropolitan France was determined using drug claims from French National Health Insurance databases. The proportions of workers in 38 industry sectors in 2006 were calculated for each canton. Associations between the proportions of workers in industry sectors and PD age/sex-standardized incidence ratios were examined using incidence rate ratios (IRR) and 95% confidence intervals (CI) estimated with multilevel negative binomial regressions with a random intercept at the canton-level and adjusted for smoking, deprivation index, and density of neurologists. We then used two-step semi-Bayes hierarchical regression (HR) to include prior information about exposure to pesticides, metals, and solvents in each industry sector. We identified 112,625 incident cases. PD incidence was higher in areas characterized by high proportions of workers in "Agriculture, forestry and fishing" (IRR HR  = 1.042; CI 95% = 1.014-1.070; p-Trend HR  = 0.004), "Manufacture of textiles, wearing apparel, leather and related products" (IRR HR  = 1.024; CI 95% = 1.005-1.044; p-Trend HR  = 0.010), and "Manufacture of basic metals and fabricated metal products, except machinery and equipment" (IRR HR  = 1.024; CI 95% = 1.003-1.046; p-Trend HR  = 0.071). This nationwide study, based on a comprehensive analysis of industry sectors, shows significant associations between high proportions of workers in specific industry sectors (agriculture, metallurgy, textile) and PD incidence that may be targeted in further epidemiological studies to replicate and better understand these associations.

  14. Supply chain risk management of newspaper industry: A quantitative study

    Science.gov (United States)

    Sartika, Viny; Hisjam, Muh.; Sutopo, Wahyudi

    2018-02-01

    The newspaper industry has several distinctive features that make it stands out from other industries. The strict delivery deadline and zero inventory led to a very short time frame for production and distribution. On the other hand, there is pressure from the newsroom to encourage the start of production as slowly as possible in order to enter the news, while there is pressure from production and distribution to start production as early as possible. Supply chain risk management is needed in determining the best strategy for dealing with possible risks in the newspaper industry. In a case study of a newspaper in Surakarta, quantitative approaches are made to the newspaper supply chain risk management by calculating the expected cost of risk based on the magnitude of the impact and the probability of a risk event. From the calculation results obtained that the five risks with the highest value are newspaper delays to the end customer, broken plate, miss print, down machine, and delayed delivery of newspaper content. Then analyzed appropriate mitigation strategies to cope with such risk events.

  15. Metrology in Pharmaceutical Industry - A Case Study

    International Nuclear Information System (INIS)

    Yuvamoto, Priscila D.; Fermam, Ricardo K. S.; Nascimento, Elizabeth S.

    2016-01-01

    Metrology is recognized by improving production process, increasing the productivity, giving more reliability to the measurements and consequently, it impacts in the economy of a country. Pharmaceutical area developed GMP (Good Manufacture Practice) requeriments, with no introduction of metrological concepts. However, due to Nanomedicines, it is expected this approach and the consequent positive results. The aim of this work is to verify the level of metrology implementation in a Brazilian pharmaceutical industry, using a case study. The purpose is a better mutual comprehension by both areas, acting together and governmental support to robustness of Brazilian pharmaceutical area. (paper)

  16. Nuclear emergency planning and response in industrial areas. Results of a qualitative study in 9 industrial companies

    International Nuclear Information System (INIS)

    Pauwels, N.; Hardeman, F.; Soudan, K.

    1998-11-01

    Substantial economic losses and potential dangerous situations may result when industrial companies unexpectedly have to shut down their activities in an abrupt way. With respect to the industrial companies located in the Antwerp harbour region, the reason for such an unplanned shut-down could be the decision to (preventively) evacuate their workers, or to have them sheltered, in case of an alarm situation at a nearby nuclear power plant of Doel or in any other adjacent industrial factory. Between January and August 1998, the prevention advisors of nine industrial companies have been interviewed to gain insight in the scale and relative importance of several economic costs and practical difficulties that may arise. Moreover, the appropriateness of the existing nuclear emergency response decision structure and intervention philosophy was investigated. The main conclusions drawn from the interviews are reported. Recommendations are made to increase the efficiency of implementing countermeasures in industrial areas

  17. Nuclear emergency planning and response in industrial areas. Results of a qualitative study in 9 industrial companies

    Energy Technology Data Exchange (ETDEWEB)

    Pauwels, N.; Hardeman, F.; Soudan, K

    1998-11-01

    Substantial economic losses and potential dangerous situations may result when industrial companies unexpectedly have to shut down their activities in an abrupt way. With respect to the industrial companies located in the Antwerp harbour region, the reason for such an unplanned shut-down could be the decision to (preventively) evacuate their workers, or to have them sheltered, in case of an alarm situation at a nearby nuclear power plant of Doel or in any other adjacent industrial factory. Between January and August 1998, the prevention advisors of nine industrial companies have been interviewed to gain insight in the scale and relative importance of several economic costs and practical difficulties that may arise. Moreover, the appropriateness of the existing nuclear emergency response decision structure and intervention philosophy was investigated. The main conclusions drawn from the interviews are reported. Recommendations are made to increase the efficiency of implementing countermeasures in industrial areas.

  18. A Study on How Industrial Pharmacists Rank Competences for Pharmacy Practice: A Case for Industrial Pharmacy Specialization

    Directory of Open Access Journals (Sweden)

    Jeffrey Atkinson

    2016-02-01

    Full Text Available This paper looks at the way in which industrial pharmacists rank the fundamental competences for pharmacy practice. European industrial pharmacists (n = 135 ranked 68 competences for practice, arranged into 13 clusters of two types (personal and patient care. Results show that, compared to community pharmacists (n = 258, industrial pharmacists rank competences centering on research, development and production of drugs higher, and those centering on patient care lower. Competences centering on values, communication skills, etc. were ranked similarly by the two groups of pharmacists. These results are discussed in the light of the existence or not of an “industrial pharmacy” specialization.

  19. A Study of Factor Affecting the Software Application Development in Indonesian Creative Industry

    Directory of Open Access Journals (Sweden)

    Adhi Nugroho Chandra

    2015-06-01

    Full Text Available The creative industries promising opportunities, especially the interactive game business. creative industries is still undeveloped, but lately has been showing its contribution to the economic development of Indonesia. Implementation of the Information and Communication Technology (ICT strategy is a new discourse that can provide great opportunities for the entrepreneurial. This study aims to reveal the level of implementation of ICT strategies, the role of government influence on the development of business, industry conditions as well as the existing value chain in the interactive games industry. Type of research conducted by descriptive research, qualitative analysis was based on the findings of desk research / literature, interviewsources, and the researcher's own knowledge. Level of subjectivity can be minimized with the help of quantitative analysis and the selection of competent resource persons in the field interviews. Secondary dataobtained from the creative economy planning books in 2025, which was published by the Ministry of Commerce of the Republic of Indonesia. Based on the research results, it is concluded that the implementation of ICTstrategies by entrepreneurs in the interactive games industry is still less, and this is partly because in general the industry is still small-scale and micro enterprises, mash the industry is relatively new in the world of business,and entrepreneurs are still concentrating the creation, production, and distributio, commercialization are being developed. In general, interactive games industry is growing. In the future, need to research business model and business strategy, so it would complement the models developing strategy in the game interactive industry.

  20. Realizing CO2 emission reduction through industrial symbiosis: A cement production case study for Kawasaki

    OpenAIRE

    Hashimoto, Shizuka; Fujita, Tsuyoshi; Geng, Yong; Nagasawa, Emiri

    2010-01-01

    This article is one effort to examine the present and potential performances of CO2 emission reduction though industrial symbiosis by employing a case study approach and life cycle CO2 analysis for alternative industrial symbiosis scenarios. As one of the first and the best-known eco-town projects, Kawasaki Eco-town was chosen as a case study area. First, the current industrial symbiosis practices in this area are introduced. To evaluate the potential of reducing the total CO2 emission throug...

  1. The Development of the Renewable Energy Power Industry under Feed-In Tariff and Renewable Portfolio Standard: A Case Study of China’s Photovoltaic Power Industry

    Directory of Open Access Journals (Sweden)

    Yuzhuo Zhang

    2017-03-01

    Full Text Available Among the regulatory policies, feed-in tariffs (FIT and renewable portfolio standards (RPS are the most popular to promote the development of renewable energy power industry. They can significantly contribute to the expansion of domestic industrial activities in terms of sustainable energy. In this paper, we synthetically consider various important factors with the analysis of the existing literature, and use system dynamics (SD to establish models of long-term development of the renewable energy power industry under FIT and RPS schemes. The model not only clearly shows the complex logical relationship between the factors but also reveals the process of coordination between the two policy tools in the development of the renewable energy power industry. In addition, as an example of development of renewable energy industry, the paper studies the development of China’s photovoltaic power industry under different scenarios. The models proposed in this paper can provide a reference for scholars to study development of the renewable energy power industry in different countries, thereby facilitating an understanding of the renewable energy power’s long-term sustainable development pattern under FIT and RPS schemes, and helping to provide references for policy-making institutions. The results show that in the perfect competitive market, the implementation of RPS can promote long-term and rapid development of China’s photovoltaic power industry given the constraints and actions of the mechanisms of RPS quota proportion, the TGC valid period, and fines, compared with FIT. At the end of the paper, policy implications are offered as references for the government.

  2. Region-specific study of the electric utility industry. Phase I, final report

    International Nuclear Information System (INIS)

    Wacaster, A.J.

    1985-07-01

    This report describes the financial background of the electric utility industry in VACAR, reports on the present condition of the industry and then assesses the future of this industry. The Virginia-Carolinas subregion (VACAR) of the Southeastern Electric Reliability Council (SERC) was selected for this regional study because of its cooperativeness and its representative mix of powerplants, for example coal, hydro, nuclear, oil. It was found that the supply of future economic electricity is in jeopardy because of the regulatory process, the increasing risk associated with large scale generating stations and the weakening of the nuclear option. A number of options for the future were considered, including deregulation, government ownership and retaining the present system with modifications. The option selected to improve the present condition of the electricity industry was to make the present system work. The present system is sound, and with modifications, problems could be solved within the existing framework. 8 figs., 4 tabs

  3. The Use of Market Feasibility Studies in the Restaurant Industry for Small and Medium-sized Restaurants

    OpenAIRE

    Kolster, Maria

    2017-01-01

    The goals of this thesis are to provide the reader with new information about market feasibility studies in the restaurant industry and to design a market feasibility template for the international restaurant industry which can be used for small and medium-sized restaurants before entering the market. The objectives are to define the ideal factors of a market feasibility study for the international restaurant industry, to learn and become an expert in feasibility studies for the restaurant i...

  4. Polish food industry 2008-2013

    OpenAIRE

    Mroczek, Robert; Drożdż, Jadwiga; Tereszczuk, Mirosława; Urban, Roman

    2014-01-01

    The aim of the study is to evaluate the functioning of the food industry and its various sectors in 2008-2013. Meat and poultry industry. Dairy industry. Fishing industry. Milling industry. Sugar industry. Oil-mill industry. Processing of fruit, vegetables and potatoes. Bakery industry. Confectionery industry. Feed industry. Production of other food products. Production of alcoholic beverages.Tobacco industry. Food industry.

  5. Segmentation of the industrial market for food commodities: A conjoint study of purchase of vegetable oils in the mayonnaise and margarine industries

    DEFF Research Database (Denmark)

    Bech-Larsen, Tino; Skytte, Hans

    Executive summary The purpose of this working paper is to study whether current market and technological developments in the vegetable oil industry can be used as the outset for a price and/or quality based segmentation of the major industrial markets for this product. More specifically we want...... that the application of concepts from ind buying behaviour to the study of commodity buying, such as the procurement of vegetable oil, is an appropriate outset, when trying to segment the market for such commodities. The article begins with a brief discussion of why food commodity markets should be segmented......, then follows current developments in the demand and technology conditions on the market for vegetable oil. Later we discuss how concepts from industrial buying behaviour can add to the understanding of commodity buying and segmentati Following this a conjoint model of vegetable oil procurement in the vegetable...

  6. Analisis Swot pada Industri Jagung Manis di Kota Payakumbuh (Studi Kasus : Jagung Manis F1aina)

    OpenAIRE

    Ningsih, Dea Gita; Sari, Lapeti; Setiawan, Deny

    2017-01-01

    The success of Industrial and trading sector have given big contribution in creating national economic structure. One of food industries in Payakumbuh city that have vase growth is F1 Aina corn industry. This study aims to determine the strengths, weaknesses, opportunities and threats in the development of Sweet Corn Industry F1Aina. Knowing the industry development strategy F1Aina Sweet Corn. The analytical method used is the SWOT analysis (Strengths, Weaknesses, opportunites, Threats). This...

  7. Energy Saving Potential, Costs and Uncertainties in the Industry: A Case Study of the Chemical Industry in Germany

    DEFF Research Database (Denmark)

    Bühler, Fabian; Guminski, Andrej; Gruber, Anna

    2017-01-01

    In Germany, 19.6 % of the industrial final energy consumption (FEC) can be allocated to the chemical industry. Energy efficiency measures with focus on the chemical industry could thus significantly contribute to reaching the German goal of reducing greenhouse gas emissions by 80 % in 2050 compared...

  8. Metallurgy of platinoids. Studies of industrial cases

    International Nuclear Information System (INIS)

    Blazy, P.; Jdid, E. A.

    2004-01-01

    The platinoids deposits, currently in exploitation, are often associated with dunitic and gabbroitic ultra-basic rocks containing copper, nickel and iron sulfides. The proportion of platinoids in these deposits is variable and requires generally an adaptation of the industrial processes for their recovery. Nevertheless, we can consider that the classical industrial way consists to treat the composite concentrates of copper-nickel-platinoids sulfides by melting/conversion operations following by hydrometallurgical operations of recovery of the basic metals Cu, Ni. These last ones concentrate the platinoids in leaching residues. In these residues, the platinoids are extracted and separated by hydrometallurgical ways including different techniques: dissolution, selective precipitation, distillation, solvent extraction, resins...The great variety of uses of platinoids makes their recycling difficult. The wastes are often too complex for being economically recycling. The environmental protection depends of the type of industry (metallurgical, chemical, mining). Some products present risks of fire and explosion. The toxicity often appears by superficial allergies and by serious troubles in case of ingestion of soluble salts. (O.M.)

  9. Student Teachers of Technology and Design into Industry: A Northern Ireland Case Study

    Science.gov (United States)

    Gibson, Ken

    2013-01-01

    This paper, based in Northern Ireland, is a case study of an innovative programme which places year 3 B.Ed. post-primary student teachers of Technology and Design into industry for a five-day period. The industrial placement programme is set in an international context of evolving pre-service field placements and in a local context defined by the…

  10. Managing Conflict in The Nigerian Construction Industry: A Study of ...

    African Journals Online (AJOL)

    The study investigated the causes of conflictin the Nigerian construction industry and, the strategies for managing them in terms of resolutions and prevention. A quantitative approach using questionnaire survey was adopted to empirically test the opinions of construction professionals on causes of conflicts and ...

  11. Study of non-Hodgkin's lymphoma mortality associated with industrial pollution in Spain, using Poisson models

    Directory of Open Access Journals (Sweden)

    Lope Virginia

    2009-01-01

    Full Text Available Abstract Background Non-Hodgkin's lymphomas (NHLs have been linked to proximity to industrial areas, but evidence regarding the health risk posed by residence near pollutant industries is very limited. The European Pollutant Emission Register (EPER is a public register that furnishes valuable information on industries that release pollutants to air and water, along with their geographical location. This study sought to explore the relationship between NHL mortality in small areas in Spain and environmental exposure to pollutant emissions from EPER-registered industries, using three Poisson-regression-based mathematical models. Methods Observed cases were drawn from mortality registries in Spain for the period 1994–2003. Industries were grouped into the following sectors: energy; metal; mineral; organic chemicals; waste; paper; food; and use of solvents. Populations having an industry within a radius of 1, 1.5, or 2 kilometres from the municipal centroid were deemed to be exposed. Municipalities outside those radii were considered as reference populations. The relative risks (RRs associated with proximity to pollutant industries were estimated using the following methods: Poisson Regression; mixed Poisson model with random provincial effect; and spatial autoregressive modelling (BYM model. Results Only proximity of paper industries to population centres (>2 km could be associated with a greater risk of NHL mortality (mixed model: RR:1.24, 95% CI:1.09–1.42; BYM model: RR:1.21, 95% CI:1.01–1.45; Poisson model: RR:1.16, 95% CI:1.06–1.27. Spatial models yielded higher estimates. Conclusion The reported association between exposure to air pollution from the paper, pulp and board industry and NHL mortality is independent of the model used. Inclusion of spatial random effects terms in the risk estimate improves the study of associations between environmental exposures and mortality. The EPER could be of great utility when studying the effects of

  12. A Descriptive Study of Perceived Impact of Gender on Employment Status, Type of Work, Industry Relationships, Working Environment & Job Satisfaction in Livestock Industry Magazines.

    Science.gov (United States)

    Jeffers, Dennis W.

    A two-part study examined the employment status, distribution, job satisfaction, and promotion opportunities of women working for livestock industry magazines. Livestock publications were chosen for this research because they are typical of industry-related magazines and are traditionally dominated by males. The mastheads of 59 magazines were…

  13. Participatory ergonomics intervention in an industrially developing country--a case study.

    Science.gov (United States)

    Helali, Faramarz; Lönnroth, Emma-Christin; Shahnavaz, Houshang

    2008-01-01

    In industrially developing countries, a few ergonomists have directed great efforts towards developing ergonomics awareness among managers and workers in organizations. There is little research on the degree of their success, though. Furthermore, access of organizations to ergonomics knowledge is usually very difficult, especially in industrially developing countries. Thus, building ergonomics awareness is certainly the first phase of the process. Three companies from one industry (44 people: 14 females and 30 males) participated in a project aimed at improving their work system. At the beginning, we needed to create a common goal and ensure participation with appropriate ergonomics tools. The findings of this study were the key issue for the ergonomics intervention (i.e., a shared vision, awakened need of change and learning). Further, to build ergonomics awareness and develop a continuous learning process in the company, it was necessary to use more ergonomics tools through workers' participation in different workplaces.

  14. Chinese bilateral intra-industry trade : A panel data study for 50 countries in the 1992-2001 period

    NARCIS (Netherlands)

    Zhang, J.; van Witteloostuijn, A.; Zhou, C.

    2005-01-01

    This study examines the features and determinants of Chinese intra-industry trade during the 1992-2001 transition period for 50 of China's trade partners. We disentangle total intra-industry trade (TIIT) into vertical intra-industry trade (VIIT) vis-a-vis horizontal intra-industry trade (HIIT),

  15. The Canadian petroleum industry: An activity study. 1987 Annual report

    International Nuclear Information System (INIS)

    1988-01-01

    This report provides financial aspects of activity in the Canadian petroleum and natural gas industry. Data are given in graphic and tabular form on revenues, sources and destinations of funds (including financing, incentives, dividend payments, capital and operational expenditures); on comparisons with other industries; on how revenues are shared between the industry and various levels of government; and on principal trends observed. Data are broken down by various industry sectors where applicable. 10 figs., 15 tabs

  16. Process industry properties in nuclear industry

    International Nuclear Information System (INIS)

    Zheng Hualing

    2005-01-01

    In this article the writer has described the definition of process industry, expounded the fact classifying nuclear industry as process industry, compared the differences between process industry and discrete industry, analysed process industry properties in nuclear industry and their important impact, and proposed enhancing research work on regularity of process industry in nuclear industry. (authors)

  17. An Empirical Study of Kirkpatrick's Evaluation Model in the Hospitality Industry

    Science.gov (United States)

    Chang, Ya-Hui Elegance

    2010-01-01

    This study examined Kirkpatrick's training evaluation model (Kirkpatrick & Kirkpatrick, 2006) by assessing a sales training program conducted at an organization in the hospitality industry. The study assessed the employees' training outcomes of knowledge and skills, job performance, and the impact of the training upon the organization. By…

  18. The Evolution of a Creative Industry : The industrial dynamics and spatial evolution of the global fashion design industry

    NARCIS (Netherlands)

    Wenting, R.

    2008-01-01

    The recent growth of creative industries has raised the interest of both policy makers and academic scholars. However, we know very little about the forces that drive the development and geography of these industries. This dissertation provides an in-depth study of the industrial dynamics and

  19. The Competitive status of the U.S. civil aviation manufacturing industry: a study of the influences of technology in determining international industrial competitive advantage

    National Research Council Canada - National Science Library

    Seitz, Frederick; Steele, Lowell W

    1985-01-01

    ... A Study of the Influences of Technology in Determining International Industrial Competitive Advantage Prepared by the U.S. Civil Aviation Manufacturing Industry Panel, Committee on Technology and International Economic and Trade Issues of the Office of the Foreign Secretary, National Academy of Engineering and the Commission on Engineering and Techni...

  20. Solar feasibility study for site-specific industrial-process-heat applications. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Murray, O.L.

    1980-03-18

    This study addresses the technical feasibility of solar energy in industrial process heat (IPH) applications in Mid-America. The study was one of two contracted efforts covering the MASEC 12-state region comprised of: Illinois, Michigan, North Dakota, Indiana, Minnesota, Ohio, Iowa, Missouri, South Dakota, Kansas, Nebraska, Wisconsin. The results of our study are encouraging to the potential future role of solar energy in supplying process heat to a varied range of industries and applications. We identified and developed Case Study documentation of twenty feasible solar IPH applications covering eight major SIC groups within the Mid-American region. The geographical distribution of these applications for the existing range of solar insolation levels are shown and the characteristics of the applications are summarized. The results of the study include process identification, analysis of process heat requirements, selection of preliminary solar system characteristics, and estimation of system performance and cost. These are included in each of the 20 Case Studies. The body of the report is divided into two primary discussion sections dealing with the Study Methodology employed in the effort and the Follow-On Potential of the identified applications with regard to possible demonstration projects. The 20 applications are rated with respect to their relative overall viability and procedures are discussed for possible demonstration project embarkment. Also, a possible extension of this present feasibility study for late-comer industrial firms expressing interest appears worthy of consideration.

  1. Implementation of Project Management Concept into Industrial Energetics: Case Study in Paper Factory

    Directory of Open Access Journals (Sweden)

    Golub Markovic

    2015-05-01

    Full Text Available Fuel changing is directly linked to market movements of energy sources, consequently, large companies adapt to these changes and move towards economically worthwhile strategies. The appearance of an energy source, change or fuel production startup, is a complex investment project in the field of industrial energetics. This research paper brings a case study of transition from gas to solid fuel in the paper factory, where the factory achieved significant savings by changing the basic fuel. In this study we applied a large number of criteria and parameters of the project management concepts (such as WBS structure, Gantt chart, SWOT analysis, criteria for settlement date, etc.. The purpose of this study is to demonstrate and broaden the knowledge base of in the industrial and energy sectors and to show significant benefits and cost savings which occur as a result of changes of energy sources in the industry involving mass production processes.

  2. Local economic regeneration in the fishing industry: a case study ...

    African Journals Online (AJOL)

    Local economic regeneration in the fishing industry: a case study. HR Lloyd, GS Horn. Abstract. Africa Insight Vol.33(4) 2003: 33-39. Full Text: EMAIL FULL TEXT EMAIL FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT. Article Metrics. Metrics Loading ... Metrics powered by PLOS ALM

  3. Joint Battery Industry Sector Study.

    Science.gov (United States)

    1994-08-31

    chemistries, primarily5 due to enviromental concerns. Due to safety issues involving mercury, 13 states have banned the commercial sale of mercury batteries...underway in the industrial n battay marketplace. It discusses, by chemistry, vends or changeovers of certain technologies and chemistries and describes the...place during use and handling. Containers range from a simple shrink wrap sleeve for button and cylindrical cells to a machined and fabricated

  4. Petroleum industry 1996; L`industrie petroliere 1996

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-12-31

    A survey on petroleum industry activities in France and in the world in 1996 is presented. The different parts and themes of the study are: evolution of the petroleum market (international and French markets, supply and demand, prices, mark-up and taxation in France and in Europe); activities in the petroleum industries (exploration and production, maritime transportation, inland transportation and storage, refining, quality of petroleum products and substitution fuels, oil distribution); environment and safety (refining, distribution and evolution of products, pipeline and maritime transportation, exploration and production); situation of the sector`s companies (oil groups, para-petroleum French industry, scientific and technical research)

  5. Petroleum industry 1996; L`industrie petroliere 1996

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-12-31

    A survey on petroleum industry activities in France and in the world in 1996 is presented. The different parts and themes of the study are: evolution of the petroleum market (international and French markets, supply and demand, prices, mark-up and taxation in France and in Europe); activities in the petroleum industries (exploration and production, maritime transportation, inland transportation and storage, refining, quality of petroleum products and substitution fuels, oil distribution); environment and safety (refining, distribution and evolution of products, pipeline and maritime transportation, exploration and production); situation of the sector`s companies (oil groups, para-petroleum French industry, scientific and technical research)

  6. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™).

    Science.gov (United States)

    Shin, Son Moon; Kim, Chun Soo; Karkada, Naveen; Liu, Aixue; Jayadeva, Girish; Han, Htay Htay

    2016-10-02

    According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice.

  7. A study on influencing factors on brand loyalty: A case study of Mobile industry

    Directory of Open Access Journals (Sweden)

    Bahman Dehestani

    2013-07-01

    Full Text Available Brand loyalty plays essential role on product development especially in mobile industry. In this paper, we present an empirical survey to study the effects of different factors including brand associate, brand awareness, distribution intensity and quality perception on brand loyalty. The proposed model of this paper is examined by designing a questionnaire consists of 16 questions in Likert scale and distributing it among 200 people who use a particular brand in mobile industry called Nokia. The results are analyzed using structural equation modeling where Cronbach alpha is calculated as 0.84. The results indicate that there is a positive relationship between perception quality as well as brand awareness and brand loyalty. In addition, there is a positive relationship between brand awareness and perception quality.

  8. Cleavages and co-operation in the UK alcohol industry: A qualitative study

    Directory of Open Access Journals (Sweden)

    Holden Chris

    2012-06-01

    Full Text Available Abstract Background It is widely believed that corporate actors exert substantial influence on the making of public health policy, including in the alcohol field. However, the industry is far from being monolithic, comprising a range of producers and retailers with varying and diverse interests. With a focus on contemporary debates concerning the minimum pricing of alcohol in the UK, this study examined the differing interests of actors within the alcohol industry, the cleavages which emerged between them on this issue and how this impacted on their ability to organise themselves collectively to influence the policy process. We conducted 35 semi-structured interviews between June and November 2010 with respondents from all sectors of the industry as well as a range of non-industry actors who had knowledge of the alcohol policy process, including former Ministers, Members of the UK Parliament and the Scottish Parliament, civil servants, members of civil society organisations and professionals. Methods The paper draws on an analysis of publicly available documents and 35 semi-structured interviews with respondents from the alcohol industry (on- and off-trade including retailers, producers of wines, spirits and beers and trade associations and a range of non-industry actors with knowledge of the alcohol policy process (including former Ministers, Members of Parliament and of the Scottish Parliament, civil servants, members of civil society organisations and professional groups. Interviews were recorded, transcribed and analysed using Nvivo qualitative analysis software. Processes of triangulation between data sources and different types of respondent sought to ensure we gained as accurate a picture as possible of industry participation in the policy process. Results Divergences of interest were evident between producers and retailers and within the retail sector between the on and off trade. Divisions within the alcohol industry, however, existed

  9. Current Debates in the Study of the Industrial Revolution.

    Science.gov (United States)

    Beaudoin, Steven M.

    2000-01-01

    Provides an overview of the literature on the debates surrounding the industrial revolution using four categories: (1) definition and characteristics; (2) context and causation; (3) impacts and scope; and (4) industrialization as a worldwide phenomenon. (CMK)

  10. State monopoly, Chinese style : a case study of the tobacco industry

    NARCIS (Netherlands)

    Cheng, Yi-Wen

    2015-01-01

    Adopting a historical institutionalist approach, this study focuses on the tobacco industry as a case study to explore why competition would happen in this state-monopoly regime from its outset and how it evolved during the past three decades in China. I argue that the emergence of competition in

  11. Report on an industrial machinery engineering policy study meeting. Studies on new energy industries; Sangyo kikai engineering seisaku kenkyukai (shin energy sangyo no kenkyu) hokokusho

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1979-07-01

    Effects extended to industrial areas by new energy development were analyzed by using the industrial relation table. Technological development of new energies can mass-produce energy without being restricted by energy resource availability, and retaining manufacturing facilities can exhibit energy reserve function with security. The technologies may be suitable for local energy supply. In the aspects of industrial policies and people's living, demands on diversification and improvement of the people's living may be responded, levels of scientific technologies may be enhanced, and contribution to improving the industrial structure may be expected. The energy industry includes a large number of related industries and has vast related areas. A large number of technology induced effects can be expected in the course of research and development. A market of huge size may be estimated in the future, by which level elevation of the industrial structure would be supported. Early promotion of the new energy development is an urgent assignment for the 1980's. In order to achieve this goal, it is necessary to promote research and development, proliferation and practical application, for which the physical strength of the present Japan must be utilized to its maximum in making human and fund investments. Expansion and improvement in the industrialization infrastructures are also important, whereas the government's subsidies must be increased, and vitality in the private sector must be incorporated into organized force. (NEDO)

  12. Leadership Talent: A Study of the Potential of People in the Australian Rail Industry

    Directory of Open Access Journals (Sweden)

    Janene Piip

    2015-09-01

    Full Text Available This paper discusses the importance of leadership talent in the rail industry in Australia. Like many other countries around the world, rail is troubled by its ability to attract new talent as older leaders with specialized knowledge retire. This study sought to identify whether the sector is making the most of the talent already existing within, knowing the barriers faced in attracting new industry entrants, and questions what can be done to strengthen current approaches to developing leaders. In exploring the meaning of leadership talent, from a skills based perspective with three levels of leaders, blended methods using semi-structured interviews and a survey were utilized. The study is important because it focuses on the people aspects of the industry, a little researched area of rail that has major implications for how employees are engaged and retained. The findings identified a certain mindset, culture and approach about leadership talent in organizations that overlooked the heterogeneity of rail organization populations, precluding certain groups of people from becoming leaders. The project identified that leadership and other soft skills required in the rail industry are both under researched, and often undervalued, for the impact that they can have on performance and productivity of companies. There are key messages from this study for both organizations as well as inspiring rail industry leaders.

  13. Fillers in the skin of color population.

    Science.gov (United States)

    Heath, Candrice R; Taylor, Susan C

    2011-05-01

    The skin of color population in the United States is rapidly growing and the cosmetic industry is responding to the demand for skin of color targeted treatments. The aging face in skin of color patients has a unique pattern that can be successfully augmented by dermal fillers. Though many subjects with skin of color were not included in the pre-market dermal filler clinical trials, some post-market studies have examined the safety and risks of adverse events in this population. The safety data from a selection of these studies was examined. Though pigmentary changes occurred, there have been no reports of keloid development. Developing a patient-specific care plan and instituting close follow up is emphasized.

  14. Occupational dermatitis. An epidemiological study in the rubber and cement industries

    Energy Technology Data Exchange (ETDEWEB)

    Varigos, G A; Dunt, D R

    1981-03-01

    An epidemiological study of occupational dermatitis in a tyre company and a cement company is reported. Ninety-seven percent of 999 tyre workers and 78% of 151 cement workers were screened by an occupational nurse and subsequently assessed by a specialist dermatologist. Prevalence rates of occupational contact dermatitis were 37 per 1000 and 68 per 1000 in the tyre and cement companies, respectively. Maintenance workers and tyre builders - particularly if they were Yugoslav and female - had high prevalence rates amongst tyre workers. Worker's compensation claim rates for the tyre company are similar to U.K. and U.S. rates for this industry. Prevalence rates of 37 per 1000 can be considered as a lower limit for this industry. The high prevalence rates in the cement company are noteworthy and require further study.

  15. The study on human resources toward industrialization in Madura

    International Nuclear Information System (INIS)

    Aziz Jakfar; Mochamad Nasrullah; Sriyana; Moch Djoko Birmano

    2007-01-01

    This research aims at arriving at rich description about human resources readiness toward industrialization by 1) determining the direction of industrialization development, 2) discovering supporting as well as interfering factors, 3) identifying alternative solution to the problems, 4) analyzing human resources capacity in terms of Human Development Index, 5) recognizing labor development strategy, 6) noticing the role of education in developing human resources, 7) formulating human resources development agenda. The goal of industrialization development in Madura region is to create such conductive circumstances for the investors that it is likely to trigger optimal industries with its potency and expansion based. Some supporting factors associated with the industrial development scenario in Madura are Suramadu bridge, the expansion of Gerbang Kertosusila into Germa Kertosusila and the availability of facilities and infrastructure. In addition, there are some interfering factors to be considered such as low perception of the local community on the importance of industrialization as well as the shortage of electricity and water intake. The alternative solutions to the obstacles above are to promote socialization program on the importance of industrialization for the advancement of Madura region by all related stakeholders while considering the use of PLTN desalination over water and electricity problems. However, human resources development capacity of Madurese, whose average capacity is considered both improper and far below the average capacity of the whole population in East Java. Nevertheless, Madurese relatively has already attained sufficient purchasing power which is above the average on East Java as a whole. Labor development strategy policy can be carried through: 1) improving accessibility to Madura to speed up the flow of outside investment, production as well as business, 2) promoting local labor force, 3) improving the prevailing economics activities

  16. Pharmacist-industry relationships.

    Science.gov (United States)

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

    2017-12-01

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

  17. A Study to Determine the Educational Needs of Industrial Technologists in the Automotive-Type Manufacturing Industries.

    Science.gov (United States)

    Hall, Ronald Walter

    Questionnaires were used to gather data about educational needs of industrial technologists in the automotive-type manufacturing industries in the United States. Each of the 101 establishments received four questionnaires; 67 (66.3 percent) returned one or more of the questionnaires. The responses of the selected individuals were analyzed by…

  18. Evaluation of waste management, manufacturing industries, from an environmental standpoint (Case Study: Savojbolagh city Alborz Province

    Directory of Open Access Journals (Sweden)

    mashaalah nikzad

    2016-06-01

    Full Text Available   Introduction and Purpose: The quantity and quality of industrial wastewater is variable owing to the different lines of production and product variety of industry. Meeting the effluent standards requires proper environmental management. The current study aimed to evaluate the industrial wastewater management in Savojbolagh, Alborz, Iran from an environmental perspective in 2013-2014. Methods: This study was cross-sectional. The data were collected through field visits, questionnaire (of Iran's Environmental Protection Agency, and controlling data from industrial plants with more than 50 workers (totally 108 units. The questionnaire included questions about the quantity, quality, and management of wastewater. Based on an environmental perspective, the way of managing industrial wastewater was classified into four index: wastewater production, per capita production, BOD (Biochemical oxygen demand per capita, and COD (Chemical Oxygen Demand per capita which were rated from1 to 6. For each index, a higher score was defined for better management. Results: The wastewater produced by industries was estimated to be 1942 cubic meters per day. Food industry alone produced 59% of the entire industrial wastewater. The industry related to animal slaughtering was shown to have the highest BOD per capita, 320 g/day per every worker; and the cellulose industry enjoyed the highest COD per capita, 561 g/day per every worker. 76% of the industries under investigation had no strategy to reduce the wastewater production. 34% of these industries possessed treatment plants, while only 17% of them were following the effluent discharge standards. The most common method of treated and untreated wastewater disposal was found to be absorbing well. Conclusion: Based on this assessment, the management of wastewater was revealed to be favorable in non-metallic minerals industry, but unfavorable in agriculture industry as the wastewater produced by

  19. Sustainable development of the wind power industry in a complex environment: a flexibility study

    International Nuclear Information System (INIS)

    Zhao, Zhen-Yu; Zhu, Jiang; Zuo, Jian

    2014-01-01

    As a new and developing green energy business in emerging economies such as China, the wind power industry chain faces some complex issues that are further compounded by turbulent internal and external environments. To deal with the complex environment, the wind power industry needs to improve its level of flexibility so that it can become more adaptable to the changing environment. Hence it is important to explore the dynamics of the wind power industry chain flexibility with respect to the ever changing environment. This study uses questionnaire surveys and expert interviews to identify the influential flexibility components of the wind power industry chain. Subsequently a fuzzy cognitive mapping (FCM) methodology was used to establish a flexibility operating mechanism model. The research found that special attention should be paid to competition flexibility, technology flexibility, and intellectual property and talent flexibility. Policies play a pivotal role in regulating the driving effects of these components of flexibility with the aim being long term sustainability of a healthy level of overall flexibility of the wind power industry chain. This should in turn facilitate the sustainable development of the industry. - Highlights: • Wind power industry shall improve flexibility to deal with complex environment. • Critical components of flexibility of wind power industry chain were identified. • An operating mechanism model for flexibility of wind power industry is proposed. • Fuzzy cognitive mapping method is employed to model the dynamics of flexibility. • Policies play a pivotal role in fostering an industry environment toward flexibility

  20. Entrepreneurial Alliances: A Study of Entrepreneurship and Strategic Alliances in the Charter School Industry

    Science.gov (United States)

    Washington, Cheryl A.

    2012-01-01

    This study investigated the practices, processes, and success rates of 15 entrepreneurial alliances in the Texas charter school industry. The research involved interdisciplinary industries (business and education) and focused on how a specific type of alliance structure utilized social innovation to exploit opportunity and impact change in the…

  1. DAMPAK HUBUNGAN INDUSTRIAL YANG BERSIFAT KAPITALISTIK TERHADAP HARMONISASI HUBUNGAN INDUSTRIAL PENGUSAHA DENGAN PEKERJA (Studi Kasus di PT Fiscous South Pacifik Kabupaten Purwakarta

    Directory of Open Access Journals (Sweden)

    H Gunarto

    2011-02-01

    Full Text Available The implementation of the concept on freedom of rights for association of trade union is facing the phenomenon of liberal capitalistic global economic trends characterized by conflicting industrial relations. The problems in this research, What are the impacts of the implementation of the concept on freedom for association in trade unions to industrial relations which is capitalistic to the workers’ welfare?. To answer these three problems, the writer used qualitative analysis with constructivism paradigm. This study draws some conclusions as follows, the implementation of the concept on freedom for association in trade unions, which is capitalistic, affects the following: (1 the high rates on labor strike, (2 the increasing number of disputes on industrial relations between the entrepreneurs and the workers.

  2. Insights from two industrial hygiene pilot e-cigarette passive vaping studies.

    Science.gov (United States)

    Maloney, John C; Thompson, Michael K; Oldham, Michael J; Stiff, Charles L; Lilly, Patrick D; Patskan, George J; Shafer, Kenneth H; Sarkar, Mohamadi A

    2016-01-01

    While several reports have been published using research methods of estimating exposure risk to e-cigarette vapors in nonusers, only two have directly measured indoor air concentrations from vaping using validated industrial hygiene sampling methodology. Our first study was designed to measure indoor air concentrations of nicotine, menthol, propylene glycol, glycerol, and total particulates during the use of multiple e-cigarettes in a well-characterized room over a period of time. Our second study was a repeat of the first study, and it also evaluated levels of formaldehyde. Measurements were collected using active sampling, near real-time and direct measurement techniques. Air sampling incorporated industrial hygiene sampling methodology using analytical methods established by the National Institute of Occupational Safety and Health and the Occupational Safety and Health Administration. Active samples were collected over a 12-hr period, for 4 days. Background measurements were taken in the same room the day before and the day after vaping. Panelists (n = 185 Study 1; n = 145 Study 2) used menthol and non-menthol MarkTen prototype e-cigarettes. Vaping sessions (six, 1-hr) included 3 prototypes, with total number of puffs ranging from 36-216 per session. Results of the active samples were below the limit of quantitation of the analytical methods. Near real-time data were below the lowest concentration on the established calibration curves. Data from this study indicate that the majority of chemical constituents sampled were below quantifiable levels. Formaldehyde was detected at consistent levels during all sampling periods. These two studies found that indoor vaping of MarkTen prototype e-cigarette does not produce chemical constituents at quantifiable levels or background levels using standard industrial hygiene collection techniques and analytical methods.

  3. Industrial symbiosis

    DEFF Research Database (Denmark)

    Sacchi, Romain; Remmen, Arne

    2017-01-01

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

  4. Study of Use Ozone Oxydan at Liquid Waste Processing of Prawn Industry

    International Nuclear Information System (INIS)

    Isyuniarto; Agus-Purwadi

    2006-01-01

    Study of use ozone oxidant at liquid waste processing prawn industry was done. This research target is to study the influence of utilization of ozone oxidant to degrade the BOD, COD and TSS in liquid waste processing of prawn industrial. Waste volume for every treatment is 500 ml, ozonization time 10 minute, with the variation of pH: 7; 8; 9; 10 and 11 by gift calcify. With pH optimal then used for the treatment variation of time of ozone gift: 0; 5; 10; 15; 20; and 25 minute. From the experiment it was obtained that the optimal condition is reached at pH = 9 and time of ozonization 20 minute. At this condition is obtained the three following parameters: BOD = 41 mg/l, COD = 54 mg/l, and TSS = 25 mg/l. The parameter have pursuant to permanent standard quality of industrial liquid waste processing of prawn according to Decree of The State's Minister of Environment No. Piece. 51/MENLH/10/1995 and Decision of Gubernur DIY No. 281/KPTS/1998, as conditions of waste of faction III. (author)

  5. Report on an industrial machinery engineering policy study meeting. Studies on new energy industries; Sangyo kikai engineering seisaku kenkyukai (shin energy sangyo no kenkyu) hokokusho

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1979-07-01

    Effects extended to industrial areas by new energy development were analyzed by using the industrial relation table. Technological development of new energies can mass-produce energy without being restricted by energy resource availability, and retaining manufacturing facilities can exhibit energy reserve function with security. The technologies may be suitable for local energy supply. In the aspects of industrial policies and people's living, demands on diversification and improvement of the people's living may be responded, levels of scientific technologies may be enhanced, and contribution to improving the industrial structure may be expected. The energy industry includes a large number of related industries and has vast related areas. A large number of technology induced effects can be expected in the course of research and development. A market of huge size may be estimated in the future, by which level elevation of the industrial structure would be supported. Early promotion of the new energy development is an urgent assignment for the 1980's. In order to achieve this goal, it is necessary to promote research and development, proliferation and practical application, for which the physical strength of the present Japan must be utilized to its maximum in making human and fund investments. Expansion and improvement in the industrialization infrastructures are also important, whereas the government's subsidies must be increased, and vitality in the private sector must be incorporated into organized force. (NEDO)

  6. Interesting article: cancer in children of nuclear industry employees: report on children aged under 25 years from nuclear industry family study

    International Nuclear Information System (INIS)

    Lallemand, J.

    1999-01-01

    This important study turns on the following of 46 107 children, whom 39 557 children of male workers and 8 883 children of female workers. Among these ones, 2 333 children were born from both parents working in nuclear industry. 111 cases of cancer whom 28 of leukemia are reported. 97% of the whole have been strictly identified. The results suggest that the incidence of malignant diseases ( leukemia and cancers) among children of parents working in nuclear industry is not different of this one observed for the entire of population. (N.C.)

  7. An Empirical Study of the Effect of Investor Sentiment on Returns of Different Industries

    Directory of Open Access Journals (Sweden)

    Chuangxia Huang

    2014-01-01

    Full Text Available Studies on investor sentiment are mostly focused on the stock market, but little attention has been paid to the effect of investor sentiment on the return of a specific industry. This paper constructs a proxy variable to examine the relationship between investor sentiment and the return of a specific industry, using the Principle Component Analysis, and finds that investor sentiment is positively correlated with the industry return of the current period and negatively correlated with that of one lag period; we classify investor sentiment as optimistic state and pessimistic state and find that optimistic investor sentiment has a positive effect on stock returns of most industries, while pessimistic investor sentiment has no effect on them; this paper further builds a two-state Markov regime switching model and finds that sentiment has different effect on different industries returns on different states of market.

  8. Long-term airborne contamination studied by attic dust in an industrial area: Ajka, Hungary

    Science.gov (United States)

    Völgyesi, P.; Jordan, G.; Szabo, Cs.

    2012-04-01

    Heavy industrial activities such as mining, metal industry, coal fired power plants have produced large amount of by-products and wide-spread pollution, particularly in the period of centrally dictated economy after WWII, in Hungary. Several studies suggest that significant amount of these pollutants have been deposited in the urban environment. Nowadays, more than half of the world's population is living in urban areas and people spend almost 80% of their lives indoors in developed countries increasing human health risk due to contamination present in urban dwellings. Attic dust sampling was applied to determine the long-term airborne contamination load in the industrial town of Ajka (Hungary). There has been a high industrial activity in Ajka since the end of the 19th century. In addition to aluminum and alumina industry, coal mining, coal fired power plant and glass industry sites, generated numerous waste heaps which act as multi-contamination sources in the area. In October 2010 the Ajka red mud tailings pond failed and caused an accidental regional contamination of international significance. The major objective of this research was to study and map the spatial distribution of heavy metal contamination in airborne attic dust samples. At 27 sampling sites 30 attic dust samples were collected. Sampling strategy followed a grid-based stratified random sampling design. In each cell a house for attic dust sample collection was selected that was located the closest to a randomly generated point in the grid cell. The project area covers a 8x8 grid of 1x1 km cells with a total area of 64 km2. In order to represent long-term industrial pollution, houses with attics kept intact for at least 30-40 years were selected for sampling. Sampling included the collection of background samples remotely placed from the industrialized urban area. The concentration of the major and toxic elements (Al, Ca, Fe, K, Mg, Mn, Na, P, S, and As, Ba, Cd, Co, Cr, Cu, Li, Mo, Ni, Pb, Se, Sn

  9. Leukaemia incidence among workers in the shoe and boot manufacturing industry: a case-control study

    Directory of Open Access Journals (Sweden)

    Forand Steven P

    2004-08-01

    Full Text Available Abstract Background Previous reports have indicated an excess of leukaemia in Broome County, New York, particularly in the Town of Union. Surveillance of cancer incidence data indicates that a large proportion of these cases occurred among males ages 65 and older. Shoe and boot manufacturing has been the largest single industry in this area throughout much of the past century. Occupational studies from Europe suggest a link between leukaemia and employment in the shoe and boot manufacturing industry. However, researchers have not found a positive association between leukaemia and employment in the shoe industry among workers in the United States. Methods A matched case-control study was conducted to investigate the association between leukaemia incidence among males 65 and older and employment in the shoe and boot manufacturing industry. Thirty-six cases of leukaemia occurring between 1981–1990; among males age 65 and older; residing in the town of Union met the study case criteria. Death certificates were obtained for each of the cases. These were matched to death certificates of 144 controls on date of death and date of birth +/- 1 year. Death certificates were then examined to determine the employer and occupation of each study subject. Conditional logistic regression was used to determine the risk of leukaemia among those working in the industry. Results The risk of both leukaemia (OR = 1.47; 95% CI 0.70, 3.09 and acute myeloid leukaemia (OR = 1.19; 95% CI 0.33, 4.28 were elevated among those employed in the shoe and boot manufacturing industry, however neither was statistically significant. Conclusion The results, though suggestive of an association between leukaemia and employment in the shoe and boot manufacturing industry, were not statistically conclusive due mainly to limited study power. Several additional limitations may also have prevented the observance of more conclusive findings. Better exposure assessment, information on

  10. The para-petroleum industry; L'industrie parapetroliere

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-07-01

    The para-petroleum industry includes societies that realize studies and installations for the deposits exploitation. This document presents the situation of the para-petroleum industry in 2001, the world investment growth of the activity, the french societies financial results and an inventory of the main operations in the amalgamation domain. (A.L.B.)

  11. An empirical study on the effect of WTO membership on Iranian Handicraft industry: A case study of Persian carpet

    Directory of Open Access Journals (Sweden)

    Zahra Shirzour Aliabadi

    2013-05-01

    Full Text Available The world Trade Organization (WTO is one of the few organizations, which could significantly influence on foreign trade and consequently on the economic structure of the countries. There are literally different people in Iran who either encourage or discourage WTO membership. Therefore, it is important to analyze Iran’s WTO membership to empower Iranian handmade carpet in international trades and to help improvement in quality of production. The purpose of this research is to study the effects of Iran’s membership in WTO to empower this industry by performing an empirical survey among 100 experts in this industry. Findings demonstrate that access to WTO plays an important role on increasing production of handmade carpet and developing this industry. In addition, the industry needs to incorporate the recent advances on technology to ensure cost efficient production materials. The industry also needs more creative and innovative ideas due to an increase competition in handmade carpet producers from other countries.

  12. Industrial feasibility study of a spent nuclear fuel package for direct deep disposal

    International Nuclear Information System (INIS)

    Le Lous, K.; Loubrieu, J.; Chupeau, J.; Serpantie, J.P.; Becle, D.; Aubry, S.

    2001-01-01

    EDF has undertaken to study the industrial feasibility of a spent nuclear fuel package meeting direct disposal requirements. In this context, a disposal concept has been defined in which packages are cooled in place until the module is finally sealed. Indeed, one of the objectives of that disposal concept is to reduce the underground area occupied by the repository. A functional analysis has been performed within the framework of that ventilated disposal concept, taking into account the phases of the package lifetime from its conditioning until the disposal post-closure phase. An industrial feasibility study is in progress, which takes into account the functional specifications and some preliminary studies. (author)

  13. A comparative study of golf industry between Yangtze River Delta, China and Central Japan

    Science.gov (United States)

    Yang, Yangfan; Jin, Pingbin; Gong, Huiwen

    2018-03-01

    As a competition event of the 2016 Olympic Game, golf sport has aroused great attention around the world. And the Yangtze River Delta(YRD) in China, has already got certain basis and qualifications of developing golf industry, but somehow far from meeting the great potential demand of the market. This research selects the Yangtze River Delta (YRD) and Central Japan (CJ), which are indifferent golf developing stages, as the objectives. Comparative studies are being carried out with an aim of revealing the discrepancies of golf industry in selected regions. The correlations between golf industry and regional economic developing level have been explored as well. Mainly based on a geographical perspective, this research presents an initial effort to combine approaches of setting comparative indexes and spatial analysis, so that golf industry of selected regions will be compared in all directions. The results reveal that great gaps exist in YRD and CJ in terms of golf construction, service, and golf consumption. Problems in developing golf industry in YRD are identified based on the empirical results. A long-term golf development in YRD that deviating from the realistic demand is attributed to both government policies and the operational principles that the market subjects hold. Based on a comparative empirical study, suggestions relating to the government as well as the market players are put forward, with an aim of guiding the golf industry to develop in a sustainable way.

  14. A Policy Intervention Study to Identify High-Risk Groups to Prevent Industrial Accidents in Republic of Korea.

    Science.gov (United States)

    Yi, Kwan Hyung; Lee, Seung Soo

    2016-09-01

    The objective of this study is to identify high-risk groups for industrial accidents by setting up 2003 as the base year and conducting an in-depth analysis of the trends of major industrial accident indexes the index of industrial accident rate, the index of occupational injury rate, the index of occupational illness and disease rate per 10,000 people, and the index of occupational injury fatality rate per 10,000 people for the past 10 years. This study selected industrial accident victims, who died or received more than 4 days of medical care benefits, due to occupational accidents and diseases occurring at workplaces, subject to the Industrial Accident Compensation Insurance Act, as the study population. According to the trends of four major indexes by workplace characteristics, the whole industry has shown a decreasing tendency in all four major indexes since the base year (2003); as of 2012, the index of industrial accident rate was 67, while the index of occupational injury fatality rate per 10,000 people was 59. The manufacturing industry, age over 50 years and workplaces with more than 50 employees showed a high severity level of occupational accidents. Male workers showed a higher severity level of occupational accidents than female workers. The employment period of working period are likely to have more occupational accidents than others. Overall, an industrial accident prevention policy must be established by concentrating all available resources and capacities of these high-risk groups.

  15. Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives

    Directory of Open Access Journals (Sweden)

    Zhengwu Lu

    2009-10-01

    Full Text Available Zhengwu LuClinical Research Department, Abbott Vascular, Santa Clara, CA, USAAbstract: Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product’s risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.Keywords: information technology, pharmacovigilance, safety, standard, risk management, adverse event

  16. Sustainability Management Program for Industries- A Case Study

    Directory of Open Access Journals (Sweden)

    Long Su Weng Alwin

    2017-01-01

    Full Text Available This research studied the effectiveness of Sustainability Management Program in improving production efficiency of the manufacturing site with verified result using the regression analysis. For this study, a dairy manufacturing industry located in Malaysia was selected and major energy consuming equipment in the industryplant were identified. Sustainability Management Program (SMP was carried out for three years and energy consumption and product has improved regression coefficients of 0.625 in 2013, 0.826 in 2014, and 0.878 in 2015 as the manufacturing site becomes more energy efficient. This suggests that the energy management should be carried out in a continuous manner with energy management team responsible for energy saving practices.

  17. The Negro in the Furniture Industry. The Racial Policies of American Industry Series.

    Science.gov (United States)

    Fulmer, William E.

    This is the twenty-eighth of a series of studies conducted to determine variances in industrial employment practices of Negroes and to develop appropriate hiring policies. This particular study sought to examine current racial employment policies in the furniture industry within the context of the industry's structure and history. Interviews with…

  18. PENINGKATAN DAYA SAING INDUSTRI MELALUI ANALISA BIAYA KUALITAS (Studi Kasus pada Perusahaan Bahan Baku Makanan

    Directory of Open Access Journals (Sweden)

    Felecia Felecia

    2004-01-01

    Full Text Available This article is about quality costs analysis to improve industrial competitiveness, through a study case at food ingredients industry. The purpose of this quality costs analysis is to know quality cost resources which are not efficient. The first condition shows that 90% of total quality costs is used as prevention cost and 8% as internal failure cost. The final condition after analysis and improvement shows no more internal failure and the average quality costs is reduced by 9.66%. Abstract in Bahasa Indonesia : Artikel ini membahas tentang analisa biaya kualitas untuk peningkatan daya saing industri, studi kasus di sebuah industri bahan baku makanan. Tujuan dari analisa biaya kualitas adalah untuk mengetahui sumber-sumber biaya kualitas yang tidak effisien. Kondisi awal perusahaan menunjukkan bahwa 90% dari total biaya kualitas digunakan sebagai biaya pencegahan, dan 8% sebagai biaya kegagalan internal. Kondisi akhir setelah dilakukan analisa dan perbaikan adalah tidak lagi ditemukan biaya kegagalan internal dan rata-rata biaya kualitas perusahaan secara umum menurun sebesar 9.66%. Kata kunci: analisa biaya kualitas, industri bahan baku makanan.

  19. Determinants of Iran's BilateralIntra-industry Trade in Pharmaceutical Industry.

    Science.gov (United States)

    Aghlmand, Siamak; Rahimi, Bahlol; Farrokh-Eslamlou, Hamidreza; Nabilou, Bahram; Yusefzadeh, Hassan

    2018-01-01

    Among non-oil and in trade arena, drug has always been strategic importance and most government especially industrialized countries pay special attention to its production and trade issues. Thus, having a comprehensive view from economic perspective to this section is essential for suggesting intervention. This was a descriptive-analytical and panel study. In this study, gravity model is used to estimate Iran's bilateral intra-industry trade in pharmaceutical products in the 2001-2012 periods. To illustrate the extent of pharmaceutical's intra-industry trade between Iran and its major trading partners, the explanatory variables of market size, income, factor endowments, distance, cultural contributions, and similarities and also special trade arrangements have been applied. Analysis of factors affecting Iran's bilateral intra-industry trade in pharmaceutical industry showed that the average GDP and cultural similarities had a significant positive impact on Iran's bilateral IIT, while the difference in GDP has a negative and significant effect. Coefficients obtained for the geographical distance and the average ratio of total capital to the labor force is not consistent with theoretical expectations. Special trade arrangements did not have significant impact on the extent of bilateral intra-industry trade between Iran and its trading partners. The knowledge of the intra-industry trade between Iran and its trade partners make integration between the countries. Factors affecting this type of trade pattern underlie its development in trade relationship. Therefore, the findings of this study would be useful in helping to develop and implement policies for the expansion of the pharmaceutical trade.

  20. An Empirical Study of Industrial Engineering and Management Curriculum Reform in Fostering Students' Creativity

    Science.gov (United States)

    Chen, Chi-Kuang; Jiang, Bernard C.; Hsu, Kuang-Yiao

    2005-01-01

    The objective of this paper is to examine the effectiveness of a creativity-fostering program in industrial engineering and management (IE&M) curriculum reform. Fostering creativity in students has become a crucial issue in industrial engineering education. In a survey of previous studies, we found few on IE&M curriculum reform. In…

  1. POLA PEMBIMBINGAN DI TEMPAT KERJA: STUDI KASUS PELAKSANAAN PROGRAM PRAKTIK INDUSTRI DI PT JMI

    Directory of Open Access Journals (Sweden)

    Nuur Wachid Abdulmajid

    2015-12-01

    Full Text Available This research aims to know: patterns of supervision conducted by the supervisor of PI in the workplace. This research took place at PT. Jaringan Multimedia Indonesia (PT. JMI as place for Industrial Practice Program. The key informants in this research were the industrial mentorsand students who participated in the industrial practice program. The data were collected through in-depth interviews, and documentation. The technical analysis of the data refered to the analysis of Miles & Huberman interactive model, including data collection, data condensation, data display, and drawing and verifying conclusions. The result shows that methods of supervision to students through mentoring that is focused on the handling of the case or case studies. So students are asked directly involved in work in the industry.

  2. Studies of a small PWR for onsite industrial power

    International Nuclear Information System (INIS)

    Klepper, O.H.; Smith, W.R.

    1977-01-01

    Information on the use of a 300 to 400 MW(t) PWR type reactor for industrial applications is presented concerning the potential market, reliability considerations, reactor plant description, construction techniques, comparison between nuclear and fossil-fired process steam costs, alternative fossil-fired steam supplies, and industrial application

  3. 76 FR 82306 - Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability

    Science.gov (United States)

    2011-12-30

    ...] Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Use of Histology in Biomarker... studies for which histology is a reference standard. This guidance discusses the processes that should be...

  4. Sustained Energy Savings Achieved through Successful Industrial Customer Interaction with Ratepayer Programs: Case Studies

    Energy Technology Data Exchange (ETDEWEB)

    Goldberg, Amelie [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Hedman, Bruce [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Taylor, Robert P. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Russell, Christopher [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2015-10-01

    Many states have implemented ratepayer-funded programs to acquire energy efficiency as a predictable and reliable resource for meeting existing and future energy demand. These programs have become a fixture in many U.S. electricity and natural gas markets as they help postpone or eliminate the need for expensive generation and transmission investments. Industrial energy efficiency (IEE) is an energy efficiency resource that is not only a low cost option for many of these efficiency programs, but offers productivity and competitive benefits to manufacturers as it reduces their energy costs. However, some industrial customers are less enthusiastic about participating in these programs. IEE ratepayer programs suffer low participation by industries across many states today despite a continual increase in energy efficiency program spending across all types of customers, and significant energy efficiency funds can often go unused for industrial customers. This paper provides four detailed case studies of companies that benefited from participation in their utility’s energy efficiency program offerings and highlights the business value brought to them by participation in these programs. The paper is designed both for rate-payer efficiency program administrators interested in improving the attractiveness and effectiveness of industrial efficiency programs for their industrial customers and for industrial customers interested in maximizing the value of participating in efficiency programs.

  5. Examining Tensions That Affect the Evaluation of Technology in Health Care: Considerations for System Decision Makers From the Perspective of Industry and Evaluators.

    Science.gov (United States)

    Desveaux, Laura; Shaw, James; Wallace, Ross; Bhattacharyya, Onil; Bhatia, R Sacha; Jamieson, Trevor

    2017-12-08

    Virtual technologies have the potential to mitigate a range of challenges for health care systems. Despite the widespread use of mobile devices in everyday life, they currently have a limited role in health service delivery and clinical care. Efforts to integrate the fast-paced consumer technology market with health care delivery exposes tensions among patients, providers, vendors, evaluators, and system decision makers. This paper explores the key tensions between the high bar for evidence prior to market approval that guides health care regulatory decisions and the "fail fast" reality of the technology industry. We examine three core tensions: balancing user needs versus system needs, rigor versus responsiveness, and the role of pre- versus postmarket evidence generation. We use these to elaborate on the structure and appropriateness of evaluation mechanisms for virtual care solutions. Virtual technologies provide a foundation for personalized, patient-centered medicine on the user side, coupled with a broader understanding of impact on the system side. However, mechanisms for stakeholder discussion are needed to clarify the nature of the health technology marketplace and the drivers of evaluation priorities. ©Laura Desveaux, James Shaw, Ross Wallace, Onil Bhattacharyya, R Sacha Bhatia, Trevor Jamieson. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 08.12.2017.

  6. Safety of lornoxicam in the treatment of postoperative pain: a post-marketing study of analgesic regimens containing lornoxicam compared with standard analgesic treatment in 3752 day-case surgery patients.

    Science.gov (United States)

    Rawal, Narinder; Krøner, Karsten; Simin-Geertsen, Marija; Hejl, Charlotte; Likar, Rudolf

    2010-01-01

    Post-marketing surveillance studies can provide supplemental data on the safety of medications in the general population. This study aimed to evaluate the safety of analgesic regimens including the NSAID lornoxicam in the short-term treatment of postoperative pain in a clinically relevant population. Randomized, open-label, multicentre, multinational, observational cohort study of 4 days' duration. In-hospital postoperative setting, with discharge to home treatment within 24 hours of surgery. Adults aged > or =18 years expected to be in need of analgesic treatment after day-case surgery. Analgesic regimens containing lornoxicam were compared with a standard analgesic treatment, which was defined as the treatment that the patient would normally receive at the centre. Following day-case surgery, patients were provided with appropriate analgesic medication, and adverse events (AEs; defined as all recorded events with symptoms) were recorded by the investigator during the in-hospital stay and by the patient for the next 3 days using entries recorded morning and evening in a patient diary. Statistical analyses tested for between-treatment differences in AEs, adverse drug reactions (ADRs; defined as events probably, possibly or unlikely to be related to treatment) and gastrointestinal AEs (GI-AEs). A total of 4152 patients were randomized to treatment. Since 400 patients did not take any analgesic, the safety population consisted of 1838 patients for lornoxicam and 1914 patients for standard analgesic treatment. Demographic and disease characteristics were similar between the two treatment groups, as were the type of surgery and the anaesthesia used in surgery. In the safety population, 16.9% of patients received no analgesic in hospital, and when analgesics were provided they were often administered in combination. Similarly, approximately 17% of patients did not take any analgesics at home. AEs were reported in 27.1% and 29.4% of patients in the lornoxicam and standard

  7. The MIND method: A decision support for optimization of industrial energy systems - Principles and case studies

    International Nuclear Information System (INIS)

    Karlsson, Magnus

    2011-01-01

    Changes in complex industrial energy systems require adequate tools to be evaluated satisfactorily. The MIND method (Method for analysis of INDustrial energy systems) is a flexible method constructed as decision support for different types of analyses of industrial energy systems. It is based on Mixed Integer Linear Programming (MILP) and developed at Linkoeping University in Sweden. Several industries, ranging from the food industry to the pulp and paper industry, have hitherto been modelled and analyzed using the MIND method. In this paper the principles regarding the use of the method and the creation of constraints of the modelled system are presented. Two case studies are also included, a dairy and a pulp and paper mill, that focus some measures that can be evaluated using the MIND method, e.g. load shaping, fuel conversion and introduction of energy efficiency measures. The case studies illustrate the use of the method and its strengths and weaknesses. The results from the case studies are related to the main issues stated by the European Commission, such as reduction of greenhouse gas emissions, improvements regarding security of supply and increased use of renewable energy, and show great potential as regards both cost reductions and possible load shifting.

  8. Quality benchmarking methodology: Case study of finance and culture industries in Latvia

    Directory of Open Access Journals (Sweden)

    Ieva Zemīte

    2011-01-01

    Full Text Available Political, socio-economic and cultural changes that have taken place in the world during the last years have influenced all the spheres. Constant improvements are necessary to sustain in rival and shrinking markets. This sets high quality standards for the service industries. Therefore it is important to conduct comparison of quality criteria to ascertain which practices are achieving superior performance levels. At present companies in Latvia do not carry out mutual benchmarking, and as a result of that do not know how they rank against their peers in terms of quality, as well as they do not see benefits in sharing of information and in benchmarking.The purpose of this paper is to determine the criteria of qualitative benchmarking, and to investigate the use of the benchmarking quality in service industries, particularly: finance and culture sectors in Latvia in order to determine the key driving factors of quality, to explore internal and foreign benchmarks, and to reveal the full potential of inputs’ reduction and efficiency growth for the aforementioned industries.Case study and other tools are used to define the readiness of the company for benchmarking. Certain key factors are examined for their impact on quality criteria. The results are based on the research conducted in professional associations in defined fields (insurance and theatre.Originality/value – this is the first study that adopts the benchmarking models for measuring quality criteria and readiness for mutual comparison in insurance and theatre industries in Latvia.

  9. International competitiveness and leakage: A case study of the European steel industry

    NARCIS (Netherlands)

    Kuik, O.J.

    2014-01-01

    This study develops and applies an analytical framework for examining the determinants of carbon leakage and competitiveness. The study has a long-term perspective and focuses on the European steel industry. For the case study, a CGE model is used to develop feasible scenarios of the evolution of

  10. A STUDY ON IMPACT OF ICT ON THE MARKETING STRATEGY OF INDIAN TOURISM INDUSTRY

    OpenAIRE

    Md. Kashif Ansari; Garima Jain; Jasleen Kaur

    2017-01-01

    Deployment of ICT has been changing the way companies in every industry conduct their business. The most impacted is the marketing department. Marketers need to constantly study the market and the rapid changes in technology to continue satisfying the new-age customers. These customers have access to multiple sources of information due to increased usage of ICT. The present study analyses the evolution of Indian tourism industry, focusing on its marketing strategies over the years. The author...

  11. Developing countries and incipient industrialization: a case study of ...

    African Journals Online (AJOL)

    Botswana's small and large towns offer good examples of incipient industrialization and enterprise clustering in a developing economy. Using data from Lobatse, a small industrial centre in Botswana, this brief paper shows that clustering in developing countries does not necessarily induce high inter-firm relationships as is ...

  12. Background radiation study of Offa industrial area of Kwara State ...

    African Journals Online (AJOL)

    A study of the external background radiation in Offa industrial area of Kwara State is hereby reported. An in-situ measurement using two Digilert radiation monitors at five different stations were carried out. A mean exposure rate of 0.0132mR/hr, which represents 20% elevation from the standard background radiation, was ...

  13. STUDY OF TRENDS AND PERSPECTIVES OF INDUSTRIAL ENGINEERING RESEARCH

    Directory of Open Access Journals (Sweden)

    H. Dastkhan

    2012-01-01

    Full Text Available

    ENGLISH ABSTRACT: Industrial engineering is an engineering discipline which, because of its multi-disciplinary nature, has played an important role in the development and optimization of different systems at macro and micro levels. In this paper, the results of a research to study the position and trend of Industrial Engineering research in recent years are described. The data from a sample of 7 114 IE-related articles from international journals during the last 27 years were used for the analysis. The results showed that the development of IE in many countries has a strong correlation with their industrial and economic development. However, IE research topics are spreading in other management and engineering departments and so there is a need to redefine the discipline and its specific areas of interest. According to the prediction made using time series analysis, the most favorite fields of IE research in future will be on subjects related to information technology, intelligent systems, optimization, quality, and supply chain management.

    AFRIKAANSE OPSOMMING: Bedryfsingenieurswese is 'n ingenieursdissipline wat vanweë die multi-dissiplinêre aard daarvan 'n belangrike rol gespeel het in die optimisering van verskillende sisteme op makroen mikrovlak. Hierdie artikel hou die resultate voor van 'n navorsingsprojek wat onderneem is om die posisie en rigting van Bedryfsingenieursnavorsing in onlangse jare te bepaal. Die data van 'n monster van 7 114 Bedryfsingenieursverwante artikels wat verskyn het in internasionale joernale oor die afgelope 27 jaar is gebruik vir die ontleding. Die resultate toon dat die groei van Bedryfsingenieurswese in verskeie lande sterk korreleer met industriële en ekonomiese ontwikkeling. Tog blyk dit dat die navorsingsonderwerpe van Bedryfsingenieurswese sprei na ander bestuurs- en ingenieursdepartemente en dus bestaan daar ‘n nodigheid om die dissipline en die spesifieke belangstellingsvelde te herdefinieer

  14. Biomarkers study in rainbow trout exposed to industrially contaminated groundwater

    Directory of Open Access Journals (Sweden)

    Nadjet Benchalgo

    2014-03-01

    Full Text Available The spill of liquid industrial waste from chemical and petrochemical industries in Mercier lagoons located 20 km south of Montreal, Quebec, caused a major groundwater contamination by industrial contaminants. The aim of this study was to investigate the toxic effects of Mercier groundwater, following 4 and 14 days of exposure to graded concentrations from three wells at increasing distances 1.2, 2.7 and 5.4 km from the source of contamination. Rainbow trout were examined for several biomarkers of defense [ethoxyresorufin O-deethylase (EROD and gluthatione S-transferase (GST activities] and those of tissue damage [lipid peroxidation (LPO and DNA strand breaks]. The results showed that EROD activity was significantly enhanced in hepatic tissue at 1.2 and 5.4 km, whereas inhibition in activity was observed in group at 2.7 km. Therefore, GST activity was significantly increased at 3.1% concentration for the 2.7 km well. No change in LPO was observed. However, a significant induction of DNA strand breaks in liver was obtained at each distance. In conclusion, the data suggest that the release of these contaminants in groundwater leads to increased biotransformation for coplanar aromatic hydrocarbons and DNA damage in groundwater.

  15. Reduction of Multi-pollutant Emissions from Industrial Sectors: The U.S. Cement Industry – A Case Study

    Science.gov (United States)

    For Frank Princiotta’s book, Global Climate Change—The Technology Challenge Carbon dioxide (CO2) accounts for more than 90% of worldwide CO2-eq green-house gas (GHG) emissions from industrial sectors other than power generation. Amongst these sectors, the cement industry is one ...

  16. China’s wood furniture manufacturing industry: industrial cluster and export competitiveness

    OpenAIRE

    Yang, hongqiang; Ji, Chunyi; Nie, Ning; Hong, Yinxing

    2012-01-01

    China is the largest furniture exporter in the world. Its wood furniture industry has become an important part of the country’s forestry economic development. Hence, investigating China’s furniture industry cluster and export competitiveness is favorable for the sustainable development of China’s forestry industry. This study indicates that, under the guidance of the export-oriented strategy of China’s reform and opening up for 30 years, the country’s furniture industry has formed three big i...

  17. Importance Of Fashion Cad Computer Aided Design Study For Garment Industry In Bangladesh..

    Directory of Open Access Journals (Sweden)

    Md. Tabraz

    2017-10-01

    Full Text Available The garment industry is rapidly growing with new concepts for keeping fashion business alive. To survive in the fashion industry new innovations are necessary for a while. In order to meet the demands for the market a computer-aided design CAD system gives opportunity for mass customization in fashion. The system enables to create more styles random changes make new design dimension of collection pattern generation graded size pattern marker creation and fabric cutting. By integrating the system with the processes of garment sewing test of fit and final adjustment mass customization can be realized in the apparel industry. For the manufacturers the efficiency of the supply chain can be improved by reducing human efforts costs and production time. For the customers better fittings with faster delivery stimulate the desire of purchase and enhance their satisfaction. This paper illustrates that why Fashion CAD study is important for garment industry in Bangladesh.

  18. Feasibility Studies of Palm Oil Mill Waste Aggregates for the Construction Industry

    Directory of Open Access Journals (Sweden)

    Jegathish Kanadasan

    2015-09-01

    Full Text Available The agricultural industry in Malaysia has grown rapidly over the years. Palm oil clinker (POC is a byproduct obtained from the palm oil industry. Its lightweight properties allows for its utilization as an aggregate, while in powder form as a filler material in concrete. POC specimens obtained throughout each state in Malaysia were investigated to evaluate the physical, chemical, and microstructure characteristics. Variations between each state were determined and their possible contributory factors were assessed. POC were incorporated as a replacement material for aggregates and their engineering characteristics were ascertained. Almost 7% of density was reduced with the introduction of POC as aggregates. A sustainability assessment was made through greenhouse gas emission (GHG and cost factor analyses to determine the contribution of the addition of POC to the construction industry. Addition of POC helps to lower the GHG emission by 9.6% compared to control specimens. By channeling this waste into the construction industry, an efficient waste-management system can be promoted; thus, creating a cleaner environment. This study is also expected to offer some guides and directions for upcoming research works on the incorporation of POC.

  19. Feasibility Studies of Palm Oil Mill Waste Aggregates for the Construction Industry

    Science.gov (United States)

    Kanadasan, Jegathish; Ahmad Fauzi, Auni Filzah; Abdul Razak, Hashim; Selliah, Paramananthan; Subramaniam, Vijaya; Yusoff, Sumiani

    2015-01-01

    The agricultural industry in Malaysia has grown rapidly over the years. Palm oil clinker (POC) is a byproduct obtained from the palm oil industry. Its lightweight properties allows for its utilization as an aggregate, while in powder form as a filler material in concrete. POC specimens obtained throughout each state in Malaysia were investigated to evaluate the physical, chemical, and microstructure characteristics. Variations between each state were determined and their possible contributory factors were assessed. POC were incorporated as a replacement material for aggregates and their engineering characteristics were ascertained. Almost 7% of density was reduced with the introduction of POC as aggregates. A sustainability assessment was made through greenhouse gas emission (GHG) and cost factor analyses to determine the contribution of the addition of POC to the construction industry. Addition of POC helps to lower the GHG emission by 9.6% compared to control specimens. By channeling this waste into the construction industry, an efficient waste-management system can be promoted; thus, creating a cleaner environment. This study is also expected to offer some guides and directions for upcoming research works on the incorporation of POC. PMID:28793579

  20. Feasibility Studies of Palm Oil Mill Waste Aggregates for the Construction Industry.

    Science.gov (United States)

    Kanadasan, Jegathish; Fauzi, Auni Filzah Ahmad; Razak, Hashim Abdul; Selliah, Paramananthan; Subramaniam, Vijaya; Yusoff, Sumiani

    2015-09-22

    The agricultural industry in Malaysia has grown rapidly over the years. Palm oil clinker (POC) is a byproduct obtained from the palm oil industry. Its lightweight properties allows for its utilization as an aggregate, while in powder form as a filler material in concrete. POC specimens obtained throughout each state in Malaysia were investigated to evaluate the physical, chemical, and microstructure characteristics. Variations between each state were determined and their possible contributory factors were assessed. POC were incorporated as a replacement material for aggregates and their engineering characteristics were ascertained. Almost 7% of density was reduced with the introduction of POC as aggregates. A sustainability assessment was made through greenhouse gas emission (GHG) and cost factor analyses to determine the contribution of the addition of POC to the construction industry. Addition of POC helps to lower the GHG emission by 9.6% compared to control specimens. By channeling this waste into the construction industry, an efficient waste-management system can be promoted; thus, creating a cleaner environment. This study is also expected to offer some guides and directions for upcoming research works on the incorporation of POC.

  1. Wood product industry - present state and studies of the development alternatives; Puuteollisuuden nykytilan ja haasteiden arviointia

    Energy Technology Data Exchange (ETDEWEB)

    Holmijoki, O.; Paajanen, T.; Kairi, M.

    2007-07-01

    In this research project the development of the wood products industry and its operating environment in Finland was studied using statistical data mainly from years 1995 - 2003. In this context, the wood products industry includes the sawmilling industry, the plywood and other wood panel industry, prefabricated wooden housing and the building joinery industry, wood packing manufacture and the manufacture of other wooden products. The development of the wood products industry and its operating environment has been estimated by combining statistical data about the business economy, production economy and the national economy from the Central Statistical Office of Finland together with data from the Finnish Forest Research Institute. Based on statistical data, the wood product markets, profitability and cost structure of branches, input market, use of labour force and investments have been studied. The economic importance of the wood products industry has been estimated at a national and a local level. Challenges facing wood products industry branches have been analysed using example calculations based on input-output theory. In the evaluation method, the business environment of the wood products industry branches and related branches, have been described with a use table at basic prices commonly using in the national economy. This method has enabled the direct and indirect effects of simultaneous quantity and price changes occurring in the wood product markets and markets related to the wood product industry, to be analysed. In the example calculations, variation of sawn timber production and log import, as well as the increments of sawn timber upgrading, wood product usage in building, wood panel production and purchase energy price, were reviewed

  2. Referral bias in hospital register studies of geographical and industrial differences in health.

    Science.gov (United States)

    Soll-Johanning, Helle; Hannerz, Harald; Tüchsen, Finn

    2004-05-01

    The Danish National Hospital Register contains four patient types: full-time inpatients, part-time inpatients, outpatients and emergency ward patients. The aim of the present study was to investigate whether results from comparative hospital register studies depend on which patient types we choose to include in the analysis. The hospital register was linked to the centralised civil register and the employment classification module. All economically active persons in Denmark aged 20-59 years 1st January 1995 (N = 2,281,480) were followed for six years. We calculated SIRs, first by county then by industry and finally by industry adjusted for county, for a variety of diagnostic groups and for each of the following types of cases: A) full-time inpatients, B) all inpatients, C) all inpatients and outpatients, D) all patients. The ratio between the maximum and the minimum of the four types of SIRs was calculated for each combination of the examined population groups and diseases. A max/min ratio was regarded as a sign of referral bias if it was above 1.2 and statistically significant. When calculating SIRs by county 46.7 percent of the max/min ratios signified referral bias. The percentage was 5.5 when calculating SIRs by industry and only 1.7 when they were calculated by industry adjusted for county. Estimates of geographical health differences are often distorted by differences in the health care organisation. Estimates of industrial health differences tend to be robust with a few identifiable exceptions. Standardisation for county will eliminate bias.

  3. Instructional Technologies in the Workforce: Case Studies from the Nuclear Industry.

    Science.gov (United States)

    Widen, William C.; Roth, Gene L.

    1992-01-01

    Describes six types of instructional technology used in the nuclear industry: Study Pacs, computerized test banks, computer-based training, interactive videodisc, artificial intelligence, and full-scope simulation. Each description presents the need, training device, outcomes, and limitations or constraints on use. (SK)

  4. Views of health journalists, industry employees and news consumers about disclosure and regulation of industry-journalist relationships: an empirical ethical study.

    Science.gov (United States)

    Lipworth, Wendy; Kerridge, Ian; Morrell, Bronwen; Forsyth, Rowena; Jordens, Christopher F C

    2015-03-01

    Bioethicists and policymakers are increasingly concerned about the effects on health journalism of relationships between journalists and private corporations. The concern is that relationships between journalists and manufacturers of medicines, medical devices, complementary medicines and food can and do distort health reporting. This is a problem because health news is known to have a major impact on the public's health-related expectations and behaviour. Commentators have proposed two related approaches to protecting the public from potential harms arising from industry-journalist interactions: greater transparency and external regulation. To date, few empirical studies have examined stakeholders' views of industry-journalist relationships and how these should be managed. We conducted interviews with 13 journalists and 12 industry employees, and 2 focus groups with consumers. Our findings, which are synthesised here, provide empirical support for the need for greater transparency and regulation of industry-journalist relationships. Our findings also highlight several likely barriers to instituting such measures, which will need to be overcome if transparency and regulation are to be accepted by stakeholders and have their intended effect on the quality of journalism and the actions of news consumers. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  5. Industrial assessment of radiofrequency and microwave radiations: case study at electronic manufacturing industries in Penang

    International Nuclear Information System (INIS)

    Mohd Zaid Abdullah

    1996-01-01

    In electronic manufacturing industry, the applications of an equipment emitting radiofrequency radiation (RFR) are numerous and Increasing. It is known that exposure to RFR at sufficiently high intensity and duration can produce a variety of adverse health effects. This paper presents some results from an extensive studies in the RFR field measurements at frequency range from 100 MHz to 1 GHz. All measurements were performed inside factories located at the Penang Free Trade Zone. In this case, the factories chosen are those that manufacture the electronic components whereby the applications of RFR equipment are likely to be intensive compared to other type of industries. The measurement system used in this study are the portable spectrum-analyzer, the passive log-periodic antenna and a desktop computer for data analysis. Results from this study have indicated that the RFR exposure levels in most factories are in the range of 7.7 x 10 sup -4 - 4.31 x 10 sup -3 Wm sup -2 and 0.01 - 0. 741 Vm sup -1 for power density and electric strength measurement respectively. These ranges are at least 100 times lower compared to the RFR protection guidelines proposed by the American National Standard Institute (ANSI). However, the exposure levels inside the factory are consistently 10 sup -3 - 10 sup -4 higher than the levels caused by natural sources and is about 10 sup 2 - 10 sup 6 higher than the levels measured at a distance of 30 m from a low-power output mobile phone transmitter. In the case of the health effect assessment, no sufficient evidence has been found to indicate the potential consequences resulting from excessive RFR exposure. Nonetheless, many factories surveyed are unaware of the existence of the international guidelines and codes on the safe use of radiofrequency energy even though, some measures are being taken to protect their employees against RFR

  6. Globalisation and Air Transportation Industry: A Case Study of Malaysia

    OpenAIRE

    Kamaruddin, Shahrul Kamal

    2010-01-01

    Air transportation remains a large and growing industry that is central to the globalisation process. The globalisation impact on the air transportation industry remains largely focused on the airlines, while the impact on airports is rarely defined. The objective of this research is to identify the processes of globalisation that impact the air transportation industry specifically on airport development and operations that will greatly influence the changing nature of airports. A survey ques...

  7. Online University-Industry Collaboration

    DEFF Research Database (Denmark)

    Søndergaard, Helle Alsted; Bergenholtz, Carsten; Juhl, Hans Jørn

    Extant studies have shown how online communities can promote collaborative and innovative activities in general. Studies on university-industry collaborations have so far focused less on online activities. We therefore set out to examine the individual and organizational drivers and barriers...... for academics and industrial professionals to contribute to online community-based platforms. We use a mixed method approach using both survey data and in-depth interviews with respondents from the Danish food sector. Findings show that in line with known studies on online innovation communities in general......, the main drivers for engagement are organizational and individual learning, and establishing connections, rather than monetary incentives. In contrast to offline studies on university-industry interactions, well-connected academics are less interested in online communities of academics and industry...

  8. Balanced scorecard application in the health care industry: a case study.

    Science.gov (United States)

    Kocakülâh, Mehmet C; Austill, A David

    2007-01-01

    Balanced scorecards became a popular strategic performance measurement and management tool in the 1990s by Robert Kaplan and David Norton. Mainline companies accepted balanced scorecards quickly, but health care organizations were slow to adopt them for use. A number of problems face the health care industry, including cost structure, payor limitations and constraints, and performance and quality issues that require changes in how health care organizations, both profit and nonprofit, manage operations. This article discusses balanced scorecards generally from theoretical and technical views, and why they should be used by health care organizations. The authors argue that balanced scorecards are particularly applicable to hospitals, clinics, and other health care companies. Finally, the authors perform a case study of the development, implementation, and use of balance scorecards by a regional Midwestern health care system. The positive and negative aspects of the subject's balanced scorecard are discussed. Leaders in today's health care industry are under great pressure to meet their financial goals. The industry is faced with financial pressures from consumers, insurers, and governments. Inflation in the industry is much higher than it is within the overall economy. Employers can no longer bear the burden of rising group health insurance costs for its employees. Too many large companies have used bankruptcy law as a shield to reduce or shift some of their legal obligations to provide health insurance coverage to present or retired employees. Stakeholders of health care providers are demanding greater control over costs. As the segment of un- or underinsured within the United States becomes larger as a percentage of the population, voters are seriously beginning to demand some form of national health insurance, which will drastically change the health care industry.

  9. Technical change in US industry: A cross-industry analysis

    Science.gov (United States)

    Nelson, R. R. (Editor)

    1981-01-01

    The nature of the public policies which have influenced the pace and pattern of technical progress in a number of American industries is studied with the view of assessing the broad effects of these policies. The industries studied are agriculture, pharmaceuticals, semiconductors, computers, civil aircraft, automobiles and residential construction. The policies considered include research and development funding as well as government procurement, education, information dissemination, patent protection, licensing, regulations, and anti-trust policies.

  10. Advanced dust control techniques in cement industry electrostatic precipitator - a case study

    International Nuclear Information System (INIS)

    Khattak, Z.; Ahmad, J.

    2011-01-01

    The case study deal with the current day problem of pollution by industrial zones in Pakistan with emphasis on the cement Industry which has been proved to be the second revenue generating hub after textile sector of the Pakistan. A pilot study into the identification and available removal Techniques of particulates from the exhaust of a cement plant clinker cooler was carried out. The objective of this work was to study the performance of the each technique in detail in the removal of a particulate with a wide range of sizes, under different operational conditions and to compare the results for collection efficiency with predictions by available theoretical models. A brief and comprehensive discussion regarding design, construction and bottlenecks of each tool has been discussed to fully ascertain it's scope and usability. First part of the study identifies the various pollutants being emitted from the chimney of a specific cement plant in Pakistan and while last portion deals with the ways to curtail these pollutants. (author)

  11. Work-Life Balance: A Study In The Petroleum Industry

    OpenAIRE

    Judy De Villiers; Elize Kotze

    2003-01-01

    A qualitative study was completed to discover how employees of a company in the petroleum industry define and experience the phenomenon of work-life balance, to identify the workplace determinants of work-life imbalance and to elicit some solutions for the problem. It was found that work-life balance is a personal issue that varies across time and situations and the underlying conflict experienced pertains to role overload and role interference. The most significant work-life conflict arises ...

  12. First-principles mechanistic studies of ammonia-related industrial processes

    OpenAIRE

    Gómez Díaz, Jaime

    2011-01-01

    In this dissertation, the mechanisms that govern four essential industrial processes have been studied by means of Density Functional Theory (DFT). The processes are the following: Ostwald (HNO3 production), Degussa and Andrussow (HCN production) and MacArthurForrest (gold recovery). In these processes, ammonia is the main raw material or a precursor of it.The KohnSham equations that describe the model systems have been solved by means of VASP and GPAW using the RPBE functional. These package...

  13. Competitiveness of the Garment Industry on the Basis of the Industrial Cluster Establishment

    Directory of Open Access Journals (Sweden)

    Tatiana Dmitrievna Sinyavets

    2016-03-01

    Full Text Available The issue of the development prospects of the Russian economy and the economy of its individual branches in the regions is highly relevant in terms of the increasing crises and economic development challenges. The scope of the study is a garment industry of the Siberian Federal District, which includes 12 subjects, and only six of them develop the garment industry actively. There are the regions of Kemerovo, Novosibirsk, Omsk, Tomsk, Krasnoyarsk Krai and the Republic of Khakassia. The subject matter of the research is the state and prospects of the garment industry of the Siberian Federal District. It also includes the assessment of the garment industry as one of the sub-sectors of the light industry in terms of its competitiveness in the domestic market. The purpose of the comprehensive study is to determine the conditions and factors affecting the development of the industry, as well as to identify its development reserves and competitiveness on the basis of industrial cluster’s generation. The hypothesis of this study is that in the Siberian Federal District, there are a need and reserves to create a cluster of the garment industry. The main methods of the study are the comparative analysis, the expert assessment of the sector in certain regions of the Siberian Federal District, as well as the assessment of possible formation of the industrial cluster in the region. The results of the study are the evaluation of the competitiveness and prospects of the garment industry in Russia and the Siberian Federal District (a low level of development and competitiveness; the evaluation of the development level of the garment industry in the Federal District, which have showed the demand for apparel products from the population and enterprises, as well as the conditions for the provision of clothing manufacture with natural fabrics and synthetic materials, labor resources and research and development achievements; also the justification of the existing

  14. An Epidemiological Study of Accidents in a Construction Industry: A Case-Control Study

    Directory of Open Access Journals (Sweden)

    Malakouti J.

    2013-01-01

    Full Text Available Background and Objectives: Despite science and technology development and their application in various industries, accidents continue to occur in many workplaces. This study was designed and carried out with the aim of epidemiological survey of accident among workers of a tunneling industry.Methods: This study was conducted on 144 out of a total of 440 employees of a tunneling project who were at risk of occupational accidents. 48 workers with a history of occupational accident over the past two years were selected as case group and 96 workers of the same project were selected as control group. The data were collected through a designed checklist and analyzed using logistic regression, chi-square and independent t tests.Results: A significant association was observed between accident rate and different age groups (p<0.05. There was a significant relationship (p=0.016 in the case of sport activities between case and control groups, and significant relationships were observed between two groups regarding education (p=0.057 and smoking (p=0.06, but there was no significant relationships between accident occurrence with marital status, residence in workplace, job related education, job experience, chronic diseases and obesity.Conclusion: The results of this study clarify the necessity of the use of epidemiological data in preventive and control measures in workplaces. Therefore, Developing programs for determination of physical and mental capacity of workers are essential to employ them in jobs commensurate with their abilities, especially in older workers.

  15. Industrial Based Migration in India. A Case Study of Dumdum "Dunlop Industrial Zone"

    Science.gov (United States)

    Das, Biplab; Bandyopadhyay, Aditya; Sen, Jayashree

    2012-10-01

    Migration is a very important part in our present society. Basically Millions of people moved during the industrial revolution. Some simply moved from a village to a town in the hope of finding work whilst others moved from one country to another in search of a better way of life. The main reason for moving home during the 19th century was to find work. On one hand this involved migration from the countryside to the growing industrial cities, on the other it involved rates of migration, emigration, and the social changes that were drastically affecting factors such as marriage,birth and death rates. These social changes taking place as a result of capitalism had far ranging affects, such as lowering the average age of marriage and increasing the size of the average family.Migration was not just people moving out of the country, it also invloved a lot of people moving into Britain. In the 1840's Ireland suffered a terrible famine. Faced with a massive cost of feeding the starving population many local landowners paid for labourers to emigrate.There was a shift away from agriculturally based rural dwelling towards urban habitation to meet the mass demand for labour that new industry required. There became great regional differences in population levels and in the structure of their demography. This was due to rates of migration, emigration, and the social changes that were drastically affecting factors such as marriage, birth and death rates. These social changes taking place as a result of capitalism had far ranging affects, such as lowering the average age of marriage and increasing the size of the average family. There is n serious disagreement as to the extent of the population changes that occurred but one key question that always arouses debate is that of whether an expanding population resulted in economic growth or vice versa, i.e. was industrialization a catalyst for population growth? A clear answer is difficult to decipher as the two variables are so

  16. The benefit of sustainable industrial cooperation. Study on the economical and ecological benefits of industrial cooperatives

    International Nuclear Information System (INIS)

    Hansen, D.H.J.M.; Lavrijsen, T.; Vermeulen, W.J.V.

    2005-01-01

    From scientific literature and policy memoranda it appears that sustainable industrial cooperatives result into economical and ecological benefits. However, little empirical data on practical results is available. Therefore, recently, an analysis has been carried out determining the benefit of industrial cooperation. The economical and ecological offer businesses a cost-effective option to reduce the environmental burden. Still, real implementation of such cooperatives is only realized yet by forerunners in the field of environmental management [nl

  17. Determinants of Iran’s Bilateral Intra-industry Trade in Pharmaceutical Industry

    Science.gov (United States)

    Aghlmand, Siamak; Rahimi, Bahlol; Farrokh-Eslamlou, Hamidreza; Nabilou, Bahram; Yusefzadeh, Hassan

    2018-01-01

    Among non-oil and in trade arena, drug has always been strategic importance and most government especially industrialized countries pay special attention to its production and trade issues. Thus, having a comprehensive view from economic perspective to this section is essential for suggesting intervention. This was a descriptive-analytical and panel study. In this study, gravity model is used to estimate Iran’s bilateral intra-industry trade in pharmaceutical products in the 2001-2012 periods. To illustrate the extent of pharmaceutical’s intra-industry trade between Iran and its major trading partners, the explanatory variables of market size, income, factor endowments, distance, cultural contributions, and similarities and also special trade arrangements have been applied. Analysis of factors affecting Iran’s bilateral intra-industry trade in pharmaceutical industry showed that the average GDP and cultural similarities had a significant positive impact on Iran’s bilateral IIT, while the difference in GDP has a negative and significant effect. Coefficients obtained for the geographical distance and the average ratio of total capital to the labor force is not consistent with theoretical expectations. Special trade arrangements did not have significant impact on the extent of bilateral intra-industry trade between Iran and its trading partners. The knowledge of the intra-industry trade between Iran and its trade partners make integration between the countries. Factors affecting this type of trade pattern underlie its development in trade relationship. Therefore, the findings of this study would be useful in helping to develop and implement policies for the expansion of the pharmaceutical trade. PMID:29881438

  18. The discourse of "social licence to operate": case study of the Australian wind industry

    Directory of Open Access Journals (Sweden)

    Nina L. Hall

    2014-12-01

    Full Text Available Social Licence to Operate is a concept from the mining industry that reflects the ongoing acceptance or approval for a development granted by local stakeholders. It is now being applied by wind farm developers. Using the Australian wind industry as a case study, this discourse analysis examined how Social Licence to Operate is perceived and operationalised, and the key themes in this conceptual and applied discourse. Discourse analysis acknowledges that language choices are not accidental and discourse reflects power relationships. The wind industry representatives interviewed considered power over the Social Licence to Operate was shared with community stakeholders. They recognised the stakeholders' power to delay or prevent projects, but rejected the notion that every stakeholder group should have veto power. Social Licence to Operate is seen by the wind industry through a business-oriented perspective, with an emphasis on business risk, and they describe the opposition to wind farms by invoking a metaphor of "battle". The industry respondents described Social Licence to Operate as incorporating the values of trust, transparency and participation—which all contribute to creating "authentic" relationships. These findings can inform Social Licence to Operate research, engagement practices, and also encourage reflection by industry representatives on their implicit intentions for stakeholder engagement.

  19. Quantitative feasibility study of magnetocaloric energy conversion utilizing industrial waste heat

    International Nuclear Information System (INIS)

    Vuarnoz, D.; Kitanovski, A.; Gonin, C.; Borgeaud, Y.; Delessert, M.; Meinen, M.; Egolf, P.W.

    2012-01-01

    Highlights: ► We model magnetic energy conversion machine for the use of industrial waste heat. ► Efficiencies and masses of the system are evaluated by a numerical model. ► Excellent potential of profitability is expected with large low-exergy heat sources. -- Abstract: The main objective of this theoretical study was to investigate under which conditions a magnetic energy conversion device (MECD) – utilizing industrial waste heat – is economically feasible. Furthermore, it was evaluated if magnetic energy conversion (MCE) has the potential of being a serious concurrent to already existing conventional energy conversion technologies. Up-today the availability of magnetocaloric materials with a high Curie temperature and a high magnetocaloric effect is rather limited. Therefore, this study was mainly focused on applications with heat sources of low to medium temperature levels. Magnetic energy conversion machines, containing permanent magnets, are numerically investigated for operation conditions with different temperature levels, defined by industrial waste heat sources and environmental heat sinks, different magnetic field intensities and different frequencies of operation (number of thermodynamic cycles per unit of time). Theoretical modeling and numerical simulations were performed in order to determine thermodynamic efficiencies and the exergy efficiencies as function of different operation conditions. From extracted data of our numerical results, approximate values of the total mass and total volume of magnetic energy conversion machines could be determined. These important results are presented dependent on the produced electric power. An economic feasibility study supplements the scientific study. It shows an excellent potential of profitability for certain machines. The most important result of this article is that the magnetic energy conversion technology can be economically and technically competitive to or even beat conventional energy

  20. Business Model Perusahaan Keluarga: Studi Kasus Pada Industri Batik

    Directory of Open Access Journals (Sweden)

    Achmad Sobirin

    2014-07-01

    Full Text Available AbstractThis paper was directed to review the existing busniness model of family firm within the contect of batik industry and propose a new one. Busniness model is conceived as the logic of doing business for value creation. Therefore business model is sometime understood as a construct, a mental model or a business paradigm, to be used as a guide on how to do every day’s business. Meanwhile, family firm, by definition is a firm in which the whole or majority of ownership is in the hand of family unit, managed by family members, and to be transferred to the next generation. Using a single case study that is Perusahaan Batik Bogavira – a family business enterprise producing and selling specifically batik Lampung, we identified that the existing business model of Perusahaan Batik Bogavira may potentially create cannibalism. Therefore we proposed a new business model configuration with the hope loyal buyers remain with the firm and at the same time firm can still maintain its growth.Keywords: business model, family firm, batik industry.Abstrak Paper ini membahas penerapan sebuah konsep yang relatif masih baru yaitu “business model” pada perusahaan keluarga yang bergerak di industry batik – Perusahaan Batik Bogavira yang memroduksi dan menjual batik khas Lampung. Tujuannya adalah untuk menelaah ulang business model berjalan sehingga bisa diketahui tingkat kecocokan business model tersebut dengan karakteristik bisnis dan lingkungannya, dan jika dianggap perlu mengusulkan business model baru yang lebih sesuai. Bahasan diawali dengan menelaah konsep business model dan perusahaan keluarga untuk mendapatkan gambaran tentang esensi kedua konsep tersebut. Secara umum business model adalah the logic of doing business for value creation sehingga business model sering disebut juga sebagai construct, mental model atau business paradigm yang menjadi panduan dalam menjalankan kegiatan bisnis. Sementara itu yang dimaksud dengan perusahaan keluarga

  1. An empirical study on absenteeism in Garment industry

    Directory of Open Access Journals (Sweden)

    T. S. Nanjundeswaraswamy

    2016-04-01

    Full Text Available bsenteeism is a major challenge for any organization in the current competitive world. Curbing absenteeism helps organizations achieve their targets and increases productivity. This study highlights the major causes of absenteeism in the production division of a garment industry under various dimensions, which influence on absenteeism like work environment, organizational culture, relation and co-operation, compensation and rewards, facilities, job satisfactory and security, and general factors. The Study helps to identify reasons for employee absenteeism in production division. Sample of 180 employees responses were considered for the study from the universe and the data were analysed, statistically. The study shows that the major factors like wages, other source of income, and bad relationship with supervisors were contributing to the major absence of employees from work. This clearly indicates that work environment, relation and co-operation, facilities provided by the organization and job satisfaction were the main components which are causing the employee absenteeism.

  2. How customer satisfaction changes behavior: A case study of banking industry

    Directory of Open Access Journals (Sweden)

    Hossein Vazifedoost

    2013-06-01

    Full Text Available An increase on competition industry from one side and the need for customer retention on the other side in banking industry create necessary motivation to learn more about customer behavior. This paper investigated the relationship between seven perspectives of banking services and customers’ attitude towards changing behavior. The seven perspectives included how bank employees’ treat customers, service prices, how to promote and market synergies, place and time to serve customers, products, equipment and process. The proposed study was implemented in two Iranian banks called Mellat and Tejarat in city of Tehran, Iran. The results indicated that all components except one case, which was “how to promote and market synergies” had meaningful and negative relationship with customer behavior.

  3. The natural gas industry in Japan and Europe. A comparative study

    International Nuclear Information System (INIS)

    Hideo Taki.

    1994-01-01

    Natural gas demand is forecast to rise dramatically in both Japan and Europe in the next two decades. Between the Japanese gas market and that of West European countries, however, there are considerable differences as well as some similarities. This study looks at demand and supply of natural gas, the history and structure of the industries, and the regulatory regimes, in both Japan and West European countries. It concentrates specifically on the latest moves towards liberalization of gas markets. Finally it considers possible implications of the European experience for the future of the industry in Japan, where not only is the government about to introduce a more competitive environment, but construction of a national transmission pipeline is under active consideration. (author)

  4. A comparative study on the Environmental Impact Assessment of industrial projects in Malaysia

    Science.gov (United States)

    Marmaya, E. A.; Mahbub, R.

    2018-02-01

    In the past decade, mankind has been manipulating the natural environment to better suit its needs for providing buildings and infrastructure for residential, commercial, business and industrial purposes. The rapid industrialization that has taken place has generated several issues regarding the environment. Therefore, managing environmental risks in construction projects has been recognized as an important process to achieve the project objectives in terms of time, cost, quality, safety and environmental sustainability. The aim of this research is to assess the environmental impact of industrial projects to the surrounding areas. The impact to the environment can be categorized into several aspects such as ecosystem impact, natural resources impact and public impact. This research employs the quantitative approach, that is, a questionnaire survey targeted at the occupants living in the surrounding areas of the case study location, namely the industrial sites in Sabah Ammonia Urea (SAMUR), Sipitang, Sabah and Lynas Advanced Materials Plant (LAMP), Gebeng Pahang. The findings of the research show that the two projects are perceived to have negative environmental impact especially for land pollution and green-house gas emissions.

  5. An Empirical Study on Marketing Prospecs and Potential of Steel Industry in India

    OpenAIRE

    Bagla, Varun

    2008-01-01

    In this dissertation, a sectoral review of the steel industry in India was taken into consideration. The emphasis was laid down in finding out to know the competitive advantages, which the large Indian Steel Companies have created overtime and their adaptation to the changing environment. I also analyzed the marketing potential and prospects of the steel industry in India. This study focuses on the two major companies in the steel sector in India, namely Steel authority of India ltd (SAIL) ...

  6. Knowledge Management as a Determining Factor in the Retention of Professionals in the Industry: A Case Study in an Organization in the Furniture Industry

    Directory of Open Access Journals (Sweden)

    Osmarina Pedro Garcia Garcia

    2017-01-01

    Full Text Available This study investigates which one(s of the knowledge management factor(s, via the tacit and/ or explicit way, are crucial in retaining professionals in a company in the furniture industry. The research was exploratory, with lifting procedure, and qualitative and quantitative approach. Data were collected from June to August 2014 in a furniture industry of Francisco Beltrão/PR, through a questionnaire applied to 224 employees of administrative, industrial and commercial areas, as follows: 11 managers, 44 responsible for the area and 169 operational employees. The Likert scale detected the frequency of respondents’ views. To provide consistency to the findings, the data obtained Multivariate Analysis statistical treatment, developed in the free R software. We applied the Main Component Analysis, Factorial Analysis, Correspondence Analysis, Correlation Analysis and Chi-squared Test separately for tacit and explicit ways. After the analysis, we concluded that through the factors shown in the study, both pathways influence the retention of employees of the surveyed company.

  7. Balancing environmental and industry sustainability: a case study of the US gold mining industry.

    Science.gov (United States)

    Finnie, Bruce; Stuart, Jeffrey; Gibson, Linda; Zabriskie, Fern

    2009-09-01

    Mandatory insurance requirements and/or mitigation fees (royalties) for mining companies may help reduce environmental risk exposure for the federal government. Mining is examined since the Environmental Protection Agency (EPA) Toxic Release Inventory reveals that this sector produces more hazardous waste than any other industrial sector. Although uncommon, environmental expense can exceed hundreds of millions of dollars per development. Of particular concern is the potential for mines to become unfunded Superfund sites. Monte Carlo simulation of risk exposure is used to establish a plausible range of unfunded federal liabilities associated with cyanide-leach gold mining. A model is developed to assess these costs and their impact on both the federal budget and corporate profitability (i.e., industry sustainability), particularly if such costs are borne by offending firms.

  8. Industrial applications of refrigeration. Utilizing industries; Applications industrielles du froid. Industries utilisatrices

    Energy Technology Data Exchange (ETDEWEB)

    Marvillet, Ch. [Ecole Centrale de Lyon, 69 - Ecully (France); Groupement pour la Recherche sur les Echangeurs Thermiques, GRETh (France)

    2001-10-01

    Refrigeration is used in most of the industrial domains: food industry (conservation of the organoleptic properties and sanitary quality of products, control of fermentation, of juice concentration and of the dehydration of products), transformation industries (plastic industry, rubber industry, mechanical industry (fretting, hardening and surface treatment of materials, dehumidification of compressed air), liquefaction and purification of industrial gases and hydrocarbons, processing of wastes (removal of VOCs, purification of liquid effluents etc..), civil engineering (consolidation of soils, cooling of big concrete structures), leisure (skating rink, artificial snow). (J.S.)

  9. Qualitative Phenomenological Study of Data Management Information System Deployments: Financial Services Industry

    Science.gov (United States)

    Kerns, Dannie J.

    2014-01-01

    The qualitative phenomenological study explored the lived experiences of financial services industry change managers to understand the genesis of low data management information system project adoption rates. The goal of the study was to find methods to improve data management information system adoption rates. The participant pool consisted of 19…

  10. The Auto Industry. Grade Nine. Resource Unit (Unit IV). Project Social Studies.

    Science.gov (United States)

    Minnesota Univ., Minneapolis. Project Social Studies Curriculum Center.

    Unit four of this curriculum plan for ninth grade social studies outlines a study of the automobile industry in the United States. Objectives state the desired generalizations, skills, and attitudes to be developed. A condensed outline of course content precedes expanded guidelines for teaching procedures and suggested resource materials. A…

  11. Industrial statistics with Minitab

    CERN Document Server

    Cintas, Pere Grima; Llabres, Xavier Tort-Martorell

    2012-01-01

    Industrial Statistics with MINITAB demonstrates the use of MINITAB as a tool for performing statistical analysis in an industrial context. This book covers introductory industrial statistics, exploring the most commonly used techniques alongside those that serve to give an overview of more complex issues. A plethora of examples in MINITAB are featured along with case studies for each of the statistical techniques presented. Industrial Statistics with MINITAB: Provides comprehensive coverage of user-friendly practical guidance to the essential statistical methods applied in industry.Explores

  12. Social capital generators? A case study of industry associations within the Vancouver new media cluster

    OpenAIRE

    Petrusevich, Michelle Regina

    2005-01-01

    This thesis uses a case study approach to explore the question: "How do civic associations affect social capital formation in an industrial cluster?" The Vancouver new meda industry is the site of thls research, which is based on over seventy interviews, statistical information from published sources, qualitative and quantitative surveys, and participant observation. The study concludes that civic associations play a crucial role in influencing the production, quality, and amount of social ca...

  13. Critical elements in implementations of just-in-time management: empirical study of cement industry in Pakistan.

    Science.gov (United States)

    Qureshi, Muhammad Imran; Iftikhar, Mehwish; Bhatti, Mansoor Nazir; Shams, Tauqeer; Zaman, Khalid

    2013-01-01

    In recent years, inventory management is continuous challenge for all organizations not only due to heavy cost associated with inventory holding, but also it has a great deal to do with the organizations production process. Cement industry is a growing sector of Pakistan's economy which is now facing problems in capacity utilization of their plants. This study attempts to identify the key strategies for successful implementation of just-in-time (JIT) management philosophy on the cement industry of Pakistan. The study uses survey responses from four hundred operations' managers of cement industry in order to know about the advantages and benefits that cement industry have experienced by Just in time (JIT) adoption. The results show that implementing the quality, product design, inventory management, supply chain and production plans embodied through the JIT philosophy which infect enhances cement industry competitiveness in Pakistan. JIT implementation increases performance by lower level of inventory, reduced operations & inventory costs was reduced eliminates wastage from the processes and reduced unnecessary production which is a big challenge for the manufacturer who are trying to maintain the continuous flow processes. JIT implementation is a vital manufacturing strategy that reaches capacity utilization and minimizes the rate of defect in continuous flow processes. The study emphasize the need for top management commitment in order to incorporate the necessary changes that need to take place in cement industry so that JIT implementation can take place in an effective manner.

  14. Management, restructuring and industrial relations : organizational change within the United Kingdom broadcasting industry, 1979-2002

    OpenAIRE

    Quinn, Brian J.

    2007-01-01

    In the past decade researchers began to remedy a literature deficit in the study of broadcasting institutions – addressing in particular the issues of labour process, restructuring and industrial relations. This thesis which considers management change, industrial relations and restructuring within the United Kingdom (‘UK’) broadcasting industry employs a case study format with a view to highlighting the variations of industry (macro) and firm (micro) based restructuring. Organizational chang...

  15. Predictive tool of energy performance of cold storage in agrifood industries: The Portuguese case study

    International Nuclear Information System (INIS)

    Nunes, José; Neves, Diogo; Gaspar, Pedro D.; Silva, Pedro D.; Andrade, Luís P.

    2014-01-01

    Highlights: • A predictive tool for assessment of the energy performance in agrifood industries that use cold storage is developed. • The correlations used by the predictive tool result from the greatest number of data sets collected to date in Portugal. • Strong relationships between raw material, energy consumption and volume of cold stores were established. • Case studies were analyzed that demonstrate the applicability of the tool. • The tool results are useful in the decision-making process of practice measures for the improvement of energy efficiency. - Abstract: Food processing and conservation represent decisive factors for the sustainability of the planet given the significant growth of the world population in the last decades. Therefore, the cooling process during the manufacture and/or storage of food products has been subject of study and improvement in order to ensure the food supply with good quality and safety. A predictive tool for assessment of the energy performance in agrifood industries that use cold storage is developed in order to contribute to the improvement of the energy efficiency of this industry. The predictive tool is based on a set of characteristic correlated parameters: amount of raw material annually processed, annual energy consumption and volume of cold rooms. Case studies of application of the predictive tool consider industries in the meat sector, specifically slaughterhouses. The results obtained help on the decision-making of practice measures for improvement of the energy efficiency in this industry

  16. Industrial applications study. Volume V. Bibliography of relevant literature. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Brown, Harry L.; Hamel, Bernard B.; Karamchetty, Som; Steigelmann, William H.; Gajanana, Birur C.; Agarwal, Anil P.; Klock, Lawrence W.; Henderson, James M.; Calobrisi, Gary; Hedman, Bruce A.; Koluch, Michael; Biancardi, Frank; Bass, Robert; Landerman, Abraham; Peters, George; Limaye, Dilip; Price, Jeffrey; Farr, Janet

    1976-12-01

    This five-volume report represents an initial Phase O evaluation of waste heat recovery and utilization potential in the manufacturing portion of the industrial sector. The scope of this initial phase was limited to the two-digit SIC level and addressed the feasibility of obtaining in-depth energy information in the industrial sector. Within this phase, a successful methodology and approaches for data gathering and assessment are established. Using these approaches, energy use and waste heat profiles were developed at the 2-digit level; with this data, waste heat utilization technologies were evaluated. The first section of the bibliography lists extensive citations for all industries. The next section is composed of an extensive literature search with abstracts for industrial energy conservation. EPA publications on specific industries and general references conclude the publication. (MCW)

  17. Feasibility study for an innovative industrial red mud utilisation method.

    Science.gov (United States)

    Kounalakis, Petros; Aravossis, Konstantinos; Karayianni, ChS

    2016-02-01

    Red mud is a high volume industrial waste, and its management poses a unique challenge. For the utilisation of red mud, an economical, energy saving, environmental friendly and widely applicable method has been found. The proposed novel method is purely chemical, and achieves the recovery of all the oxides contained in red mud totally and transforms them into high value added products. The present work shows that an investment in an industrial plant, treating red mud and turning a toxic industrial waste in commercial products, is safe and viable. © The Author(s) 2015.