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Sample records for cervarix postmarketing requirement

  1. 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...

  2. Review of Transporter-Related Postmarketing Requirement or Postmarketing Commitment Studies.

    Science.gov (United States)

    Fan, Ying; Sun, Bo; Agarwal, Sheetal; Zhang, Lei

    2016-07-01

    The objectives of this report are to summarize the content and status of transporter-related postmarketing requirement (PMR)/postmarketing commitment (PMC) studies in new drug applications (NDAs) approved by the U.S. Food and Drug Administration (FDA) and to discuss the reasons for requesting such studies and the impact of PMR/PMC study results on labeling to guide the optimal use of the drugs. Multiple data sources were searched to collect information on transporter-related PMR/PMC studies between January 1999 and May 2015. A total of 40 transporter-related PMR/PMC study requests were issued for 35 NDAs. Among these PMR/PMC studies, 27 requested studies related to P-glycoprotein. As of May 31, 2015, 34 transporter-related PMR/PMC studies (85%) are considered "fulfilled" (per the FDA's PMR/PMC website), and 22 (65%) resulted in labeling updates. The majority of the PMR/PMC studies are for drugs in the therapeutic areas of anti-infectives, oncology, and neurology. The results from PMR/PMC studies are important for dosing optimization and are often included in the updated labeling. Because a significant lag time is anticipated between drug approval and PMR/PMC fulfillment, NDA applicants are encouraged to include transporter-related assessments in clinical drug development programs for drug products. PMID:27385175

  3. 77 FR 13339 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements...

    Science.gov (United States)

    2012-03-06

    ...Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and......

  4. Human Papillomavirus (HPV) Vaccine (Cervarix)

    Science.gov (United States)

    ... changes or ringing in the ears. Like all vaccines, HPV vaccines will continue to be monitored for unusual ... gov/std/hpv and http://www.cdc.gov/vaccines HPV Vaccine (Cervarix) Information Statement. U.S. Department of Health ...

  5. HPV vaccine (human papillomavirus) Cervarix - what you need to know

    Science.gov (United States)

    ... is taken in its entirety from the CDC HPV (Human Papillomavirus) Cervarix® Vaccine Information Statement: www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv-cervarix.html . CDC review information for HPV Cervarix® ...

  6. HPV vaccine (human papillomavirus) Cervarix - what you need to know

    Science.gov (United States)

    ... changes or ringing in the ears. Like all vaccines, HPV vaccines will continue to be monitored for unusual ... Vaccine information statement: HPV (Human Papillomavirus) Cervarix ® VIS. Centers for Disease Control and Prevention Web site. www.cdc.gov/vaccines/ ...

  7. 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...

  8. [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. PMID:27220799

  9. Comparison of the Immunogenicity and Reactogenicity of Cervarix and Gardasil Human Papillomavirus Vaccines in HIV-Infected Adults

    DEFF Research Database (Denmark)

    Nielsen, Lars Toft; Storgaard, Merete; Müller, Martin;

    2013-01-01

    Objectives. To compare the immunogenicity and reactogenicity of Cervarix(®) or Gardasil(®) Human Papillomavirus (HPV) vaccines in HIV-infected adults.Methods. A double-blind, controlled trial randomizing HIV-positive adults to receive three doses of Cervarix(®) or Gardasil(®) at 0, 1.5 and 6 months.......Results. Ninety-two participants were included in the study. Anti-HPV-18 antibody titers were higher in the Cervarix(®) group compared with the Gardasil(®) group at 7 and 12 months. No significant differences in anti-HPV-16 antibody titers were found among vaccine groups. Among Cervarix(®) vaccinees, women had.......Conclusions. Both vaccines were immunogenic and well tolerated. Compared with Gardasil(®), Cervarix(®) induced superior vaccine responses among HIV-infected women whereas in HIV-infected men the difference in immunogenicity was less pronounced....

  10. 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

  11. FDA Approves Two HPV Vaccines: Cervarix for Girls, Gardasil for Boys | Division of Cancer Prevention

    Science.gov (United States)

    The FDA has approved a second vaccine to prevent cervical cancer and cervical precancers, the vaccine’s manufacturer, GlaxoSmithKline (GSK), announced last week. The approval is based on data from a large clinical trial showing that the vaccine, Cervarix, prevented precancerous lesions in 93 percent of those who received the full vaccine sequence of three injections over 6 months. |

  12. Postmarket policy considerations for biosimilar oncology drugs.

    Science.gov (United States)

    Renwick, Matthew J; Smolina, Kate; Gladstone, Emilie J; Weymann, Deirdre; Morgan, Steven G

    2016-01-01

    Oncology biological products are some of the most expensive drugs on the market and are a growing financial burden on patients and health-care systems. By 2020, numerous major biological cancer drugs will lose their patent protection allowing follow-on competitors, known as biosimilars, to enter the market. Clinical and regulatory considerations for biosimilars have begun to harmonise in Europe and the USA to help to define and streamline the pathway for biosimilar market authorisation. Yet, substantial international variation still exists in the pricing and market uptake of approved biosimilar oncology drugs. Differences in national postmarket policies for biosimilars might explain these disparities in pricing and uptake. In this Policy Review, policy approaches to competition between biosimilars and originators used by seven European countries--Belgium, France, Germany, Italy, the Netherlands, Norway, and the UK--and the USA are discussed, chosen because these countries represent a variety of postmarket policies and build on conclusions from previous work. We discuss these policies within the context of interchangeability, physician prescribing, substitutability, pharmacist dispensing, hospital financing and tendering, and pricing. PMID:26758759

  13. 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. PMID:23818199

  14. Postmarket Drug Safety Information for Patients and Providers

    Science.gov (United States)

    ... Health and Human Services FDA U.S. Food and Drug Administration Protecting and Promoting Your Health A to ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Drug Safety and Availability Postmarket Drug ...

  15. 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

    2015-07-01

    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. PMID:26167249

  16. Signal detection using change point analysis in postmarket surveillance†

    OpenAIRE

    Xu, Zhiheng; Kass-Hout, Taha; Anderson-Smits, Colin; Gray, Gerry

    2015-01-01

    Purpose Signal detection methods have been used extensively in postmarket surveillance to identify elevated risks of adverse events associated with medical products (drugs, vaccines, and devices). However, current popular disproportionality methods ignore useful information such as trends when the data are aggregated over time for signal detection. Methods In this paper, we applied change point analysis (CPA) to trend analysis of medical products in a spontaneous adverse event reporting syste...

  17. A randomized, observer-blinded immunogenicity trial of Cervarix(® and Gardasil(® Human Papillomavirus vaccines in 12-15 year old girls.

    Directory of Open Access Journals (Sweden)

    Eve Draper

    Full Text Available BACKGROUND: The current generation of Human Papillomavirus (HPV vaccines, Cervarix® and Gardasil®, exhibit a high degree of efficacy in clinical trials against the two high-risk (HR genotypes represented in the vaccines (HPV16 and HPV18. High levels of neutralizing antibodies are elicited against the vaccine types, consistent with preclinical data showing that neutralizing antibodies can mediate type-specific protection in the absence of other immune effectors. The vaccines also confer protection against some closely related non-vaccine HR HPV types, although the vaccines appear to differ in their degree of cross-protection. The mechanism of vaccine-induced cross-protection is unknown. This study sought to compare the breadth and magnitudes of neutralizing antibodies against non-vaccine types elicited by both vaccines and establish whether such antibodies could be detected in the genital secretions of vaccinated individuals. METHODS AND FINDINGS: Serum and genital samples were collected from 12-15 year old girls following vaccination with either Cervarix® (n = 96 or Gardasil® (n = 102 HPV vaccine. Serum-neutralizing antibody responses against non-vaccine HPV types were broader and of higher magnitude in the Cervarix®, compared to the Gardasil®, vaccinated individuals. Levels of neutralizing and binding antibodies in genital secretions were closely associated with those found in the serum (r = 0.869, with Cervarix® having a median 2.5 (inter-quartile range, 1.7-3.5 fold higher geometric mean HPV-specific IgG ratio in serum and genital samples than Gardasil® (p = 0.0047. There was a strong positive association between cross-neutralizing antibody seropositivity and available HPV vaccine trial efficacy data against non-vaccine types. CONCLUSIONS: These data demonstrate for the first time that cross-neutralizing antibodies can be detected at the genital site of infection and support the possibility that cross-neutralizing antibodies play a

  18. Clinical application of human papillomavirus vaccines Gardasil and Cervarix%预防性人乳头瘤病毒疫苗Gardasil和Cervarix的临床应用

    Institute of Scientific and Technical Information of China (English)

    龙琦琦; 夏和霞; 张炜

    2016-01-01

    Oncogenic human papillomavirus (HPV) infection is the main cause of cervical cancer and anogenital and oropharyngeal cancers. A bivalent vaccine Cervarix and a quadrivalent vaccine Gardasil have been applying in vaccination programs around the world. Some highly immunogenic, safe, and effective vaccines are now available to control HPV-related diseases with proven efifcacy against diseases at many anatomical sites, including the cervix, vulva, vagina, anus, and penis ones. The data from pre-licensure and post-licensure studies have showed that both Cervarix and Gardasil are vaccines with high safety. However, there are some barriers in the promotion and application of HPV vaccination.%人乳头瘤病毒(human papillomavirus, HPV)感染可能导致宫颈癌、肛门生殖器癌和口咽癌。目前,已得到世界范围内应用的HPV疫苗主要有二价疫苗Cervarix和四价疫苗Gardasil。高免疫原性、安全、有效的HPV疫苗可预防和控制多个部位,包括宫颈、外阴、阴道、肛门和阴茎等的HPV感染相关疾病。上市前、后的研究都显示, Cervarix和Gardasil具有很高的安全性。但其推广应用也面临一些问题。

  19. 77 FR 52745 - Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal...

    Science.gov (United States)

    2012-08-30

    ... Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle AGENCY: Food and Drug... Device Data for Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle... relatively short, product life-cycle. For these reasons, FDA's Center for Devices and Radiological...

  20. 21 CFR 26.50 - Alert system and exchange of postmarket vigilance reports.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Alert system and exchange of postmarket vigilance... EUROPEAN COMMUNITY Specific Sector Provisions for Medical Devices § 26.50 Alert system and exchange of postmarket vigilance reports. (a) An alert system will be set up during the transition period and...

  1. Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.

    Science.gov (United States)

    Sekine, S; Pinnow, E E; Wu, E; Kurtzig, R; Hall, M; Dal Pan, G J

    2016-07-01

    In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-related label changes. Among 458 newly approved products, 300 were the subjects of a scheduled analysis; a new safety signal that resulted in a safety-related label change was found for 11 of these products. Less than 2% of 713 safety-related label changes were based on the scheduled analyses. Our study suggests that the safety summary analyses provide only marginal value over other pharmacovigilance activities. PMID:26853718

  2. Indicators of Drug-Seeking Aberrant Behaviours: The Feasibility of Use in Observational Post-Marketing Cohort Studies for Risk Management

    OpenAIRE

    Layton, Deborah; Osborne, Vicki; Al-Shukri, Mohammad; Shakir, Saad A W

    2014-01-01

    Background Problematic prescription drug use is reflected by or associated with drug-seeking aberrant behaviours. Research gaps include lack of post-marketing evidence and instruments. As part of the pharmacovigilance requirements, a risk management plan was developed for fentanyl buccal tablets (FEBT) by the manufacturer, with an additional pharmacovigilance activity requested by the regulatory authority, to investigate the risks of misuse, abuse, criminal use, off-label use and accidental e...

  3. PREVALENSI DAN KARAKTERISTIK PELAYANAN VAKSINASI CERVARIX SEBAGAI PREVENSI PRIMER KANKER SERVIKS DI SMP NEGERI 1 DENPASAR PERIODE OKTOBER 2011 - APRIL 2012

    Directory of Open Access Journals (Sweden)

    Hendrikus Gede Surya Adhi Putra

    2015-06-01

    Full Text Available Vaksin Human Papillomavirus (HPV saat ini menjadi metode pencegahan yang paling diperhitungkan terhadap infeksi HPV yang merupakan etiologi kanker cervix. Peningkatan efektifitas vaksin HPV terjadi pada pemberian dalam rentang usia prapubertas dan remaja. Pemberian vaksin yang menargetkan usia tersebut dapat menjaring wanita yang masih belum aktif secara seksual, sehingga probabilitas terpapar HPV masih rendah. Disamping itu, respon imunitas yang dihasilkan juga lebih besar dibandingkan pemberian pasca pubertas. Tujuan penelitian ini untuk mengetahui prevalensi vaksinasi cervarix sebagai upaya prevensi primer kanker serviks di SMP Negeri 1 Denpasar. Penelitian ini menggunakan metode deskriptif retrospektif dan dilaksanakan di SMP Negeri 1 Denpasar pada tanggal 8 November 2012. Dengan sampel yakni siswi yang mengikuti program vaksinasi HPV cervarix di SMP Negeri 1 Denpasar pada 15 Oktober 2011, 12 November 2011, dan 14 April 2012. Dari penelitian ini diperoleh yang mengikuti program vaksinasi sebanyak 46 siswi dari 420 siswi atau 10,95%. Hasil distribusi yang tertinggi, menurut umur usia 14 tahun (43,48%, kelas IX (17,95%, asal daerah Denpasar (50%, mempunyai 3 saudara kandung (39,13%, pendidikan orang tua sarjana (82,61%, pekerjaan orang tua sebagai PNS (32,61%, penghasilan orang tua diatas 3 juta (45,65%. Berdasarkan  hasil  penelitian  ini,  dapat  disimpulkan  bahwa  kesadaran siswi SMP Negeri 1 Denpasar mengenai vaksin HPV berada dalam kategori rendah. Oleh karena itu, diperlukan sosialisasi yang berkesinambungan untuk memberikan pemahaman dan kesadaran mengenai pentingnya upaya pencegahan primer kanker serviks, yaitu melalui vaksinasi.

  4. PREVALENSI DAN KARAKTERISTIK PELAYANAN VAKSINASI CERVARIX SEBAGAI PREVENSI PRIMER KANKER SERVIKS DI SMP NEGERI 1 DENPASAR PERIODE OKTOBER 2011 - APRIL 2012

    Directory of Open Access Journals (Sweden)

    Hendrikus Gede Surya Adhi Putra

    2015-07-01

    Full Text Available Vaksin Human Papillomavirus (HPV saat ini menjadi metode pencegahan yang paling diperhitungkan terhadap infeksi HPV yang merupakan etiologi kanker cervix. Peningkatan efektifitas vaksin HPV terjadi pada pemberian dalam rentang usia prapubertas dan remaja. Pemberian vaksin yang menargetkan usia tersebut dapat menjaring wanita yang masih belum aktif secara seksual, sehingga probabilitas terpapar HPV masih rendah. Disamping itu, respon imunitas yang dihasilkan juga lebih besar dibandingkan pemberian pasca pubertas. Tujuan penelitian ini untuk mengetahui prevalensi vaksinasi cervarix sebagai upaya prevensi primer kanker serviks di SMP Negeri 1 Denpasar. Penelitian ini menggunakan metode deskriptif retrospektif dan dilaksanakan di SMP Negeri 1 Denpasar pada tanggal 8 November 2012. Dengan sampel yakni siswi yang mengikuti program vaksinasi HPV cervarix di SMP Negeri 1 Denpasar pada 15 Oktober 2011, 12 November 2011, dan 14 April 2012. Dari penelitian ini diperoleh yang mengikuti program vaksinasi sebanyak 46 siswi dari 420 siswi atau 10,95%. Hasil distribusi yang tertinggi, menurut umur usia 14 tahun (43,48%, kelas IX (17,95%, asal daerah Denpasar (50%, mempunyai 3 saudara kandung (39,13%, pendidikan orang tua sarjana (82,61%, pekerjaan orang tua sebagai PNS (32,61%, penghasilan orang tua diatas 3 juta (45,65%.Berdasarkan  hasil  penelitian  ini,  dapat  disimpulkan  bahwa  kesadaran siswi SMP Negeri 1 Denpasar mengenai vaksin HPV berada dalam kategori rendah. Oleh karena itu, diperlukan sosialisasi yang berkesinambungan untuk memberikan pemahaman dan kesadaran mengenai pentingnya upaya pencegahan primer kanker serviks, yaitu melalui vaksinasi.

  5. 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

  6. Is Post-Marketing Drug Surveillance Possible in the Family Practice Setting? A Collaborative Study

    OpenAIRE

    Facklam, David P.; Baker, Myrna I.; Jacqueline S. Gardner; Herbert, Carol; Grava-Gubins, Inese

    1988-01-01

    Post-marketing surveillance is a mechanism to identify and quantify harmful, as well as beneficial, effects of drugs used under conditions different from those in which they were tested. The College of Family Physicians of Canada collaborated with the authors in a pilot, office-based, post-marketing, surveillance study. Target medications were selected from all prescriptions, written or authorized by participating physicians. The participants collected the prescriptions by using duplicate pre...

  7. Comparison of the immunogenicity of Cervarix® and Gardasil® human papillomavirus vaccines for oncogenic non-vaccine serotypes HPV-31, HPV-33, and HPV-45 in HIV-infected adults

    DEFF Research Database (Denmark)

    Nielsen, Lars Toft; Tolstrup, Martin; Müller, Martin;

    2014-01-01

    Individuals infected with human immunodeficiency virus (HIV) have excess risk of developing human papillomavirus (HPV)-related disease. A substantial fraction of HPV-associated cancers is caused by HPV serotypes not included in the currently available vaccines. Among healthy women, both Cervarix......(®) (HPV-16/18, GlaxoSmithKline Biologicals, GSK) and Gardasil(®) (HPV-6/11/16/18, Merck) have demonstrated partial cross-protection against certain oncogenic non-vaccine HPV-types. Currently, there are no available data on vaccine-induced cross-protection in men and little is known about cross......-reactive immunity after HPV-vaccination of HIV-infected individuals. In an investigator-initiated trial, we randomized 91 HIV-positive men and women to receive vaccination with Cervarix(®) or Gardasil(®). The HPV-DNA status of the participants was determined with pcr before and after immunization. Cross...

  8. [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. PMID:22292397

  9. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Science.gov (United States)

    2010-04-01

    ... then at annual intervals. The applicant shall submit each quarterly report within 30 days of the close... annual report within 60 days of the anniversary date of approval of the application. Upon written notice... § 314.80 Postmarketing reporting of adverse drug experiences. (a) Definitions. The following...

  10. 美国新药上市后定期汇总报告的研究%Study on the post-marketing aggregate reports in the United States

    Institute of Scientific and Technical Information of China (English)

    孙新欣

    2013-01-01

    周期性药物不良事件报告和药品年度报告是美国新药上市后的美国食品药品监督管理局要求药企递交的两种主要的定期汇总报告。这两种报告为管理上市药品、评估药品风险利益提供了必要的信息。文章介绍了两种报告的汇报时限和内容,并将这两种报告与中国采用的定期安全性更新报告进行了比较,指出不同。最后阐述了定期汇总报告在未来的变化趋势,希望对国内该领域工作起到参考借鉴作用。%Periodic adverse drug experience report and annual report are the two major post-marketing aggregate reports required by U.S. Food and Drug Administration (FDA) once a new drug application is approved in the United States. The two post-marketing aggregate reports provide necessary safety and efifcacy information to FDA for beneift-risk evaluation. This article introduces the two major post-marketing periodic aggregate reports, which are compared with the Periodic Safety Update Report (PSUR) adopted in China so as to point out their differences. Finally, the future direction of the post-marketing aggregate reports is evolved. And hopefully the information contained in this article can be referred and used in the pharmaceutical industry of China.

  11. [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. PMID:25532372

  12. 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

  13. Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan†

    OpenAIRE

    Kurita, Tomoko; Kitaichi, Tomomi; Nagao, Takako; Miura, Toshiyuki; Kitazono, Yoshifumi

    2014-01-01

    Purpose Abacavir is a nucleoside reverse transcriptase inhibitor indicated for human immunodeficiency virus (HIV) infection. In Japan, Ziagen® (300-mg abacavir sulfate) has been marketed since 1999. To obtain safety data on Ziagen, a mandatory postmarketing surveillance was conducted between September 1999 and September 2009. Methods A joint survey [HIV-related Drug Surveys (HRD)] has been conducted involving manufacturers of drugs for HIV treatment in Japan. Safety data from total 643 cases ...

  14. Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan

    OpenAIRE

    Kurita, Tomoko; Kitaichi, Tomomi; Nagao, Takako; Miura, Toshiyuki; Kitazono, Yoshifumi

    2014-01-01

    Purpose: Abacavir is a nucleoside reverse transcriptase inhibitor indicated for human immunodeficiency virus (HIV) infection. In Japan, Ziagen® (300-mg abacavir sulfate) has been marketed since 1999. To obtain safety data on Ziagen, a mandatory postmarketing surveillance was conducted between September 1999 and September 2009. Methods: A joint survey [HIV-related Drug Surveys (HRD)] has been conducted involving manufacturers of drugs for HIV treatment in Japan. Safety data from total 643 case...

  15. Post-marketing surveillance of enalapril: experience in 11 710 hypertensive patients in general practice

    OpenAIRE

    Cooper, Warren D.; Sheldon, David; Brown, Derek; Kimber, Graham R.; Isitt, Valerie L.; Currie, William J.C.

    1987-01-01

    Post-marketing surveillance in general practice represents an important part of the monitoring of adverse events associated with newly introduced drugs. Such a study of the angiotensin-converting enzyme inhibitor enalapril maleate has been undertaken in 11 710 patients with essential hypertension. Serious adverse events occurred in 1.7% of patients, though most of these were not thought to be related to the treatment. The incidence rates of death (0.09%), stroke (0.11%) and myocardial infarct...

  16. 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. PMID:16758501

  17. 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

  18. The use of existing environmental networks for the post-market monitoring of GM crop cultivation in the EU.

    Science.gov (United States)

    Smets, G; Alcalde, E; Andres, D; Carron, D; Delzenne, P; Heise, A; Legris, G; Martinez Parrilla, M; Verhaert, J; Wandelt, C; Ilegems, M; Rüdelsheim, P

    2014-07-01

    The European Union (EU) Directive 2001/18/EC on the deliberate release of genetically modified organisms (GMOs) into the environment requires that both Case-Specific Monitoring (CSM) and General Surveillance (GS) are considered as post-market implementing measures. Whereas CSM is directed to monitor potential adverse effects of GMOs or their use identified in the environmental risk assessment, GS aims to detect un-intended adverse effects of GMOs or their use on human and animal health or the environment. Guidance documents on the monitoring of genetically modified (GM) plants from the Commission and EFSA clarify that, as appropriate, GS can make use of established routine surveillance practices. Networks involved in routine surveillance offer recognised expertise in a particular domain and are designed to collect information on important environmental aspects over a large geographical area. However, as the suitability of existing monitoring networks to provide relevant data for monitoring impacts of GMOs is not known, plant biotechnology companies developed an approach to describe the processes and criteria that will be used for selecting and evaluating existing monitoring systems. In this paper, the availability of existing monitoring networks for this purpose is evaluated. By cataloguing the existing environmental monitoring networks in the EU, it can be concluded that they can only be used, in the context of GMO cultivation monitoring, as secondary tools to collect baseline information. PMID:24836113

  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. PMID:22292395

  20. Regulations and guidelines should be strengthened urgently for re-evaluation on post-marketing medicines in China.

    Science.gov (United States)

    Xie, Yan-Ming; Tian, Feng

    2013-07-01

    This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on postmarketing surveillance (also named pharmacovigilance), therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China's actual conditions, and cooperating with multidisciplinary researchers. PMID:23818198

  1. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

    Science.gov (United States)

    Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug. PMID:26183623

  2. Postmarketing safety experience with edoxaban in Japan for thromboprophylaxis following major orthopedic surgery

    Directory of Open Access Journals (Sweden)

    Kuroda Y

    2013-10-01

    Full Text Available Yasufumi Kuroda,1 Chie Hirayama,2 Hitoshi Hotoda,2 Yasuhiro Nishikawa,2 Akinori Nishiwaki21Daiichi Sankyo Pharma Development, Edison, NJ, USA; 2Daiichi Sankyo Company, Limited, Tokyo, JapanPurpose: Edoxaban is an oral, once-daily, selective, direct factor Xa inhibitor approved in Japan for the prevention of venous thromboembolism following major orthopedic surgery. Currently, edoxaban is in Phase III clinical development for the prevention of stroke and systemic embolic events in patients with atrial fibrillation, and for the treatment and prevention of recurrences of venous thromboembolism. This report describes the adverse drug reactions (ADRs spontaneously reported during early postmarketing phase vigilance from the time of its commercial launch in Japan.Materials and methods: All spontaneously reported ADRs following edoxaban use received by Daiichi Sankyo during early postmarketing phase vigilance from July 19, 2011, to January 18, 2012, were entered into the safety database and included in this review. Approximately 20,000 patients were estimated to have been treated with edoxaban.Results: The mean age of patients was 74.2 years, their mean weight was 59.4 kg, and approximately 70% were female. A total of 67 ADRs were reported in 56 patients, of which the majority included bleeding events (51 ADRs in 42 patients. Of these, 15 ADRs (in 14 patients were serious, including cerebral hemorrhage (n = 1, gastric hemorrhage (n = 2; gastric hemorrhage [n = 1] and gastric ulcer hemorrhage [n = 1], and surgical-site hemorrhage (n = 12; hemorrhage [n = 6], subcutaneous hemorrhage [n = 3], wound hemorrhage [n = 2], and wound hematoma [n = 1]. Most ADRs occurred within the first week of treatment and there were no fatalities. Nonserious ADRs associated with bleeding that occurred in >1 patient included subcutaneous hemorrhage (n = 9, wound hemorrhage (n = 5, postprocedural hematoma (n = 4, anemia (n = 4, and hemarthrosis (n = 3. Other nonserious ADRs

  3. 21 CFR 314.81 - Other postmarketing reports.

    Science.gov (United States)

    2010-04-01

    ... product by established name and by proprietary name. (3) The new drug application or abbreviated... advertisement for a prescription drug product. Mailing pieces and labeling that are designed to contain samples... Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the...

  4. 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.

  5. [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. PMID:26983223

  6. 76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505...

    Science.gov (United States)

    2011-04-01

    ... Federal Register of July 15, 2009 (74 FR 34358), FDA announced the availability of a draft guidance for... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Postmarketing Studies and Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act;...

  7. 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

  8. Composite sequential Monte Carlo test for post-market vaccine safety surveillance.

    Science.gov (United States)

    Silva, Ivair R

    2016-04-30

    Group sequential hypothesis testing is now widely used to analyze prospective data. If Monte Carlo simulation is used to construct the signaling threshold, the challenge is how to manage the type I error probability for each one of the multiple tests without losing control on the overall significance level. This paper introduces a valid method for a true management of the alpha spending at each one of a sequence of Monte Carlo tests. The method also enables the use of a sequential simulation strategy for each Monte Carlo test, which is useful for saving computational execution time. Thus, the proposed procedure allows for sequential Monte Carlo test in sequential analysis, and this is the reason that it is called 'composite sequential' test. An upper bound for the potential power losses from the proposed method is deduced. The composite sequential design is illustrated through an application for post-market vaccine safety surveillance data. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26561330

  9. 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.)

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

    International Nuclear Information System (INIS)

    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.)

  11. Significantly Reduced Genoprevalence of Vaccine-Type HPV-16/18 Infections among Vaccinated Compared to Non-Vaccinated Young Women 5.5 Years after a Bivalent HPV-16/18 Vaccine (Cervarix®) Pilot Project in Uganda

    Science.gov (United States)

    Berggren, Vanja; Wabinga, Henry; Lillsunde-Larsson, Gabriella; Helenius, Gisela; Kaliff, Malin; Karlsson, Mats; Kirimunda, Samuel; Musubika, Caroline; Andersson, Sören

    2016-01-01

    The objective of this study was to determine the prevalence and some predictors for vaccine and non-vaccine types of HPV infections among bivalent HPV vaccinated and non-vaccinated young women in Uganda. This was a comparative cross sectional study 5.5 years after a bivalent HPV 16/18 vaccination (Cervarix®, GlaxoSmithKline, Belgium) pilot project in western Uganda. Cervical swabs were collected between July 2014-August 2014 and analyzed with a HPV genotyping test, CLART® HPV2 assay (Genomica, Madrid Spain) which is based on PCR followed by microarray for determination of genotype. Blood samples were also tested for HIV and syphilis infections as well as CD4 and CD8 lymphocyte levels. The age range of the participants was 15–24 years and mean age was 18.6(SD 1.4). Vaccine-type HPV-16/18 strains were significantly less prevalent among vaccinated women compared to non-vaccinated women (0.5% vs 5.6%, p 0.006, OR 95% CI 0.08(0.01–0.64). At type-specific level, significant difference was observed for HPV16 only. Other STIs (HIV/syphilis) were important risk factors for HPV infections including both vaccine types and non-vaccine types. In addition, for non-vaccine HPV types, living in an urban area, having a low BMI, low CD4 count and having had a high number of life time sexual partners were also significant risk factors. Our data concurs with the existing literature from other parts of the world regarding the effectiveness of bivalent HPV-16/18 vaccine in reducing the prevalence of HPV infections particularly vaccine HPV- 16/18 strains among vaccinated women. This study reinforces the recommendation to vaccinate young girls before sexual debut and integrate other STI particularly HIV and syphilis interventions into HPV vaccination packages. PMID:27482705

  12. Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis

    Science.gov (United States)

    Harigai, Masayoshi; Ishiguro, Naoki; Inokuma, Shigeko; Mimori, Tsuneyo; Ryu, Junnosuke; Takei, Syuji; Takeuchi, Tsutomu; Tanaka, Yoshiya; Takasaki, Yoshinari; Yamanaka, Hisashi; Watanabe, Masahiko; Tamada, Hiroshi; Koike, Takao

    2016-01-01

    Abstract Objective: To perform a postmarketing surveillance study evaluating the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis (RA). Methods: Safety and effectiveness data were collected for all RA patients (at 772 sites) treated with intravenous abatacept between September 2010 and June 2011. Patients were treated by the approved dosing regimen according to the package insert. Treatment effectiveness was evaluated at baseline and at weeks 4, 12, and 24 using Disease Activity Score 28 (DAS28) according to erythrocyte sedimentation rate or serum C-reactive protein concentrations. Results: Overall, 3882 and 3016 abatacept-naïve RA patients were included in safety and effectiveness analyses, respectively. Adverse drug reactions (ADRs) were reported for 15.66% of patients and serious ADRs were detected for 2.52% of patients. The incidence of serious infections was 1.03% and these were mainly attributed to different types of bacterial pneumonia. Disease activity improved significantly over 6 months. Separate multivariate analysis identified predictors of severe ADR, and severe infections and factors predictive of clinically meaningful DAS28 improvement after 6 months of treatment with abatacept. Conclusions: Abatacept was efficacious and well tolerated in a clinical setting. No new safety concerns were detected. PMID:26635183

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

    International Nuclear Information System (INIS)

    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)

  14. 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.

  15. Post-marketing Surveillance for Combined Oral Contraceptive Containing Desogestrel (Marvelon?) in Chinese Rural Areas

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    Objective To assess the side effects and the continuation rate of combined oral contraceptive (COC) containing desogestrel (Marvelon ) during 12 months. Methods This was a post-marketing surveillance study on Marvelon COC among 870 healthy rural women in 5 different counties of Jiangsu Province during 12 months. Results About 24.02% of the women who used Marvelon COC experienced side effects during 12 months. Gastrointestinal disorder, bleeding/spotting and chloasma were ranked the first three in the side effects. The rate of side effects of Marvelon COC users during the first 3 months in southern area of Jiangsu was significantly higher than that of users in northern area of Jiangsu. Most of the users did not experience obvious weight changes i.e., loss or increase in weight of more than 5 kg during 12 months. Blood pressure and biochemical indicators of almost 99% among users were within the normal range. The gross cumulative continuation rate for 12 months was 83.14%; the most common medical reason for discontinuation was gastrointestinal disorder. There was an increased risk of discontinuation use among women with lower educational level.Conclusion Marvelon COC brought fewer side effects and was well accepted when applied in Chinese rural women.

  16. Safety and tolerability of moxifloxacin in the treatment of respiratory tract infections: a post-marketing surveillance conducted in Indonesia

    Directory of Open Access Journals (Sweden)

    Arini Setiawati

    2005-03-01

    Full Text Available Moxifloxacin 400 mg tablet has been marketed in Indonesia for several indications, i.e. acute exacerbation of chronic bronchitis (AECB, community-acquired pneumonia (CAP, and acute bacterial sinusitis (ABS. To assess the safety and tolerability of moxifloxacin, a post-marketing surveillance study was conducted in the year 2001 involving 589 physicians. Clinical efficacy was also evaluated, both by physicians and patients, using a 6-symptom total score, which was scaled 0-12. A total of 1715 patients with acute sinusitis, CAP, AECB, and other infections were treated with oral moxifloxacin 400 mg once daily. There were 151 (8.8% patients with adverse events (AEs and 5 (0.29% patients with serious adverse events (SAEs that were considered related to moxifloxacin treatment. The most common adverse reactions were nausea (4.96%, dizziness (1.52%, vomiting (0.64%, headache (0.47%, and weakness (0.47%. Twenty three (1.34% patients discontinued treatment due to adverse events. Tolerance to treatment was rated very good and good by 647 (37.7% and 919 (53.6% of patients, respectively. Based on physicians’ clinical assessment, 57.7% of patients were cured and 39.9% were improved at the end of treatment. Mean total symptom score, as assessed by the patients, decreased from 6.43 on day-1 to 2.76 on day-3. Totally, 95.3% of patients felt better after receiving moxifloxacin and 97.6% of patients had good impression on moxifloxacin treatment. In conclusion, treatment of respiratory tract infections, mainly AECB, CAP and ABS, with moxifloxacin 400 mg once daily in this post-marketing surveillance was shown to be safe and well tolerated. Moxifloxacin was also shown to be highly effective in the treatment of these infections with rapid improvement of symptoms. (Med J Indones 2005; 14: 11-19Keywords : post-marketing survtillance, PMS, moxifloxacin, respiratory tract infections

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

    International Nuclear Information System (INIS)

    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

  18. Statement on the post-marketing monitoring of the use of lycopene

    Directory of Open Access Journals (Sweden)

    EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA

    2015-01-01

    Full Text Available Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA was asked to provide an update of its exposure assessment on lycopene as a novel food ingredient in the context of Regulation (EC No 258/97 taking into account the new additional information from the post-marketing monitoring programme imposed by the Commission Decisions authorising the use of synthetic lycopene, lycopene oleoresin from tomatoes and lycopene from Blakeslea trispora as a novel food ingredient in several foodstuffs. The marketing authorisation holders for the use of lycopene as a novel food ingredient jointly prepared and submitted a dossier containing sales data, product launch data, an intake estimate and toxicological information. On the basis of information on sales and new product launch data for the period from July 2009 to June 2012 provided by the lycopene manufacturers, food supplements appear to be the main source of lycopene after intake from natural occurrence. Since no new toxicological studies became available, there is no scientific basis on which the ADI established by EFSA in 2008 could be reconsidered. On the basis of previous intake assessments performed by EFSA and data on sales and product launch data provided for the period from July 2009 to June 2012, the Panel concludes that intakes of naturally occurring lycopene and from its use as a food colouring and as a novel food ingredient at permitted use levels do not lead to intakes above the ADI of 0.5 mg/kg bw/day.

  19. 21 CFR 822.21 - What must I do if I want to make changes to my postmarket surveillance plan after you have...

    Science.gov (United States)

    2010-04-01

    ... postmarket surveillance plan after you have approved it? 822.21 Section 822.21 Food and Drugs FOOD AND DRUG... after you have approved it? You must receive our approval in writing before making changes in your plan... our approval, you must submit three copies of the request to make the proposed change and...

  20. Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data

    Directory of Open Access Journals (Sweden)

    D’Urzo AD

    2015-08-01

    Full Text Available Anthony D D’Urzo,1 Edward M Kerwin,2 Kenneth R Chapman,3 Marc Decramer,4 Robert DiGiovanni,5 Peter D’Andrea,6 Huilin Hu,6 Pankaj Goyal,5 Pablo Altman6 1Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada; 2Clinical Research Institute of Southern Oregon, PC, Medford, USA; 3Asthma and Airway Centre, University Health Network, Toronto Western Hospital, Toronto, ON, Canada; 4Respiratory Division, University of Leuven, Leuven, Belgium; 5Novartis Pharma AG, Basel, Switzerland; 6Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA Background: Chronic use of inhaled anticholinergics by patients with chronic obstructive pulmonary disease (COPD has raised long-term safety concerns, particularly cardiovascular. Glycopyrronium is a once-daily anticholinergic with greater receptor selectivity than previously available agents. Methods: We assessed the safety of inhaled glycopyrronium using data pooled from two analysis sets, involving six clinical studies and over 4,000 patients with COPD who received one of the following treatments: glycopyrronium 50 µg, placebo (both delivered via the Breezhaler® device, or tiotropium 18 µg (delivered via the HandiHaler® device. Data were pooled from studies that varied in their duration and severity of COPD of the patients (ie, ≤12 weeks duration with patients having moderate or severe COPD; and >1 year duration with patients having severe and very severe COPD. Safety comparisons were made for glycopyrronium vs tiotropium or placebo. Poisson regression was used to assess the relative risk for either active drug or placebo (and between drugs where placebo was not available for assessing the incidence of safety events. During post-marketing surveillance (PMS, safety was assessed by obtaining reports from various sources, and disproportionality scores were computed using EMPIRICA™. In particular, the cardiac safety of glycopyrronium during the post-marketing phase was

  1. [Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background].

    Science.gov (United States)

    Wang, Lian-xin; Xie, Yan-ming; Ai, Qing-hua; Song, Nian-bin

    2015-12-01

    This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety. PMID:27245017

  2. [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. PMID:25532370

  3. Safety and tolerability of fluvastatin XL in the treatment of hyper-cholesterolemia : a postmarketing surveillance conducted in Indonesia

    Directory of Open Access Journals (Sweden)

    Arini Setiawati

    2008-06-01

    Full Text Available Fluvastatin XL 80 mg tablet has been marketed in Indonesia since December 2002. This post-marketing surveillance (PMS was conducted between May 2004 and April 2005 involving 98 general physicians to observe the safety and tolerability of fluvastatin XL 80 mg once daily at bedtime for 8 weeks in the treatment of outpatients with hypercholesterolemia. The efficacy of the drug in lowering LDL-cholesterol and other lipid parameters was also observed in daily clinical practice in this PMS. A total of 740 patients were eligible for safety analyses. There were 32 patients (4.32% with 39 adverse events that were considered related to fluvastatin XL therapy. The most common adverse reactions were dizziness (2.03%, nausea (1.22%, and myalgia (0.68%. No serious adverse event (SAE was found in this PMS, and no patient discontinued due to adverse event. According to physician’s global evaluation, the safety and tolerability of treatment was good in 91.9% of patients. For efficacy analyses, only 566 patients were eligible. At week 8, fluvastatin XL caused decreases in LDL-cholesterol (LDL-C, total cholesterol (TC and triglyceride (TG levels by 28.6%, 30.2% and 24.5%, respectively, and an increase in HDL-cholesterol (HDL-C by 14.3%. In 74 patients with baseline TG > 300 mg/dL, the decrease in TG was 38.1% and the increase in HDL-C was 18.1%. Reduction in LDL-C of > 40% occurred in 19.6% of the patients. In conclusion, treatment with fluvastatin XL 80 mg once daily for 8 weeks in this PMS was shown to be safe and well tolerated, and also effective in reducing LDL-C, TC and TG, and raising HDL-C in daily clinical practice. (Med J Indones 2008; 17:88-95Keywords: post-marketing surveillance (PMS, fluvastatin XL, hypercholesterolemia

  4. [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. PMID:22292377

  5. Revised annual post-market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2013 from Monsanto Europe S.A.

    OpenAIRE

    Birch, Andrew Nicholas; Casacuberta, Josep; De Schrijver, Adinda; Gathmann, Achim; Guerche, Philippe; Gralak, Mikolaj; Jones, Huw; Manachini, Barbara; Messéan, Antoine; Naegeli, Hanspeter; Ebbesen Nielsen, Elsa; Nogué, Fabien; Robaglia, Christophe; Rostoks, Nils; Sweet, Jeremy

    2015-01-01

    Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the results of the general surveillance activities contained in the revised annual post-market environmental monitoring (PMEM) report for the 2013 growing season of maize MON 810 provided by Monsanto Europe S.A. The supplied data do not indicate any unanticipated adverse effects on human and animal health or the environment arising from ...

  6. Cases Recruitment Strategy for Post-marketing Drug Reevaluation%药品上市后临床试验的病例募集策略

    Institute of Scientific and Technical Information of China (English)

    曹红波

    2012-01-01

    病例募集是上市后药品临床试验质量控制的重要环节,采取有效的募集策略往往有助于增加募集病例的数量、提高募集病例的质量,最终保证临床试验能够保质保量地完成.基于目前上市后药品临床试验的特点和现状分析,针对如何采取有效的策略进行病例募集展开论述,希望能够为以后药品上市后临床研究的质量控制提供思路和帮助.%Casse recruitment is an important factor for the quality control of post-marketing drug clinical trials. Effective recruitment strategies will contribute to increase the case number and improve the study quality, to ensure the clinical trials finished with quality assurance. Here is to analyze the features and status of post-marketing clinical trials, and discuss related strategies on the case recruitment, in the hope of providing some ideas and help to the quality control of post-marketing drug clinical study.

  7. 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

  8. Development of a drug safety ePlatform for physicians, pharmacists, and consumers based on post-marketing adverse events

    Directory of Open Access Journals (Sweden)

    Keith B. Hoffman

    2013-07-01

    Full Text Available Rigorous clinical trials under the watchful eye of regulators remain the cornerstone of drug safety. However, the emergence of serious and life-threatening Adverse Events (AEs across best-selling drug classes [sometimes many years after winning Food and Drug Administration (FDA approval] underscores the limitations of current clinical trial processes and reinforces the need for careful post-approval pharmacovigilance. The FDA’s sizeable repository of patient case reports linking AEs to approved drugs is the Adverse Event Reporting System (FAERS. We believe that open and user-friendly access to the millions of case reports in FAERS would help advance the field of post-marketing pharmacovigilance. However, FAERS data are virtually inaccessible to most physicians, pharmacists, and consumers. Accordingly, we have recently launched a big data platform (www.AdverseEvents.com that, unlike previous efforts, provides on-demand, user-friendly, and high-impact access to FAERS data. Bringing the power of big data to regular users, such as clinicians, pharmacists, and patients, is the logical next step in the transformation of health care to a model of shared decision making between consumers and the system.

  9. 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.

  10. 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. PMID:23818200

  11. 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.

  12. Assessment of malignancy risk in patients with multiple sclerosis treated with intramuscular interferon beta-1a: retrospective evaluation using a health insurance claims database and postmarketing surveillance data

    Directory of Open Access Journals (Sweden)

    Bloomgren G

    2012-06-01

    Full Text Available Gary Bloomgren, Bjørn Sperling, Kimberly Cushing, Madé WentenBiogen Idec Inc., Weston, MA, USABackground: Intramuscular interferon beta-1a (IFNβ-1a, a multiple sclerosis (MS therapy that has been commercially available for over a decade, provides a unique opportunity to retrospectively assess postmarketing data for evidence of malignancy risk, compared with relatively limited data available for more recently approved therapies. Postmarketing and claims data were analyzed to determine the risk of malignancy in MS patients treated with intramuscular IFNβ-1a.Materials and methods: The cumulative reporting rates of suspected adverse drug reactions coded to malignancy in the intramuscular IFNβ-1a global safety database were compared with malignancy incidence rates in the World Health Organization GLOBOCAN database. In addition, using data from a large US claims database, the cumulative prevalence of malignancy in MS patients treated with intramuscular IFNβ-1a was compared with non-MS population controls, MS patients without intramuscular IFNβ-1a use, and untreated MS patients. Mean follow-up was approximately 3 years for all groups, ie, 3.1 years for the intramuscular IFNβ-1a group (range 0.02–6.0 years, 2.6 years for non-MS population controls (range 0–6.0 years, 2.6 years for the intramuscular IFNβ-1a nonuse group (range 0.01–6.0 years, and 2.4 years for the untreated MS group (range 0.01–6.0 years.Results: An estimated 402,250 patients received intramuscular IFNβ-1a during the postmarketing period. Cumulative reporting rates of malignancy in this population were consistent with GLOBOCAN incidence rates observed within the general population. The claims database included 12,894 MS patients who received intramuscular IFNβ-1a. No significant difference in malignancy prevalence was observed in intramuscular IFNβ-1a users compared with other groups.Conclusion: Results from this evaluation provide no evidence of an increased risk of

  13. Hepatoxicity associated with weight-loss supplements: A case for better post-marketing surveillance

    Institute of Scientific and Technical Information of China (English)

    Ano Lobb

    2009-01-01

    There is a growing number of case reports of hepatoxicity from the widely marketed weight-loss supplement Hydroxycut, which contains the botanical ingredient Garcinia cambogia. These case reports may substantially undercount the true magnitude of harm. Based on the past experience with harmful dietary supplements, US regulators should assume the more precautionary approach favored by Canada and Europe. Lacking effective adverse event surveillance for supplements, or the requirements to prove safety prior to coming to the market, case reports such as those summarized here assume added importance.

  14. 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 S.); J.-M. Sinning (Jan-Malte); N.M. van Mieghem (Nicolas); G. Zucchelli (Giulio); G. Nickenig (Georg); R. Bekeredjian (Raffi); B. Bosmans; 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, Minnes

  15. Post-marketing health technology monitoring. The analysis of an experience from a clinical perspective

    Directory of Open Access Journals (Sweden)

    Nora eIbargoyen-Roteta

    2011-07-01

    Full Text Available Introduction: A system for monitoring the use of aphaeresis in the treatment of Ulcerative Colitis (UC, named SiMAC, was designed in 2006 in the Basque Country. In the present study, the opinion of the clinicians who participated in SiMAC was evaluated, in order to identify the barriers and gather suggestions that could improve implementation of this kind of system. Methods: A mixed questionnaire was designed, in order to gather clinicians’ assessments of the SiMAC monitoring system. Results: The response rate was 73.9% (17/23. The data from 40.96% (159/388 of patients with UC treated with aphaeresis was recorded. The main reasons for not including the data from all treated patients were a lack of required data or not meeting the study inclusion criteria. Positive aspects of the SiMAC were identified, as the simplicity of data collection and its systematic, multi-centre approach. The negative aspects mentioned were the use of a local computer application and the lack of time for health professionals to enter data. Discussion: The use of monitoring systems helps to formalise the introduction of technologies of little-known effectiveness; involve clinicians and medical societies in coming to agreement and obtaining information about the safety, effectiveness or efficiency of new technologies; and provide relevant information to healthcare administrations for making decisions about the introduction of new technologies into healthcare practice. In order for a monitoring system to work, the process must be straightforward. A minimum set of key variables that are easy to collect must be selected, and an effort made to involve a range of stakeholders, especially institutions and scientific societies, to support the work group.

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    Fujiwara, Masakazu; Kawasaki, Yohei; Yamada, Hiroshi

    2016-01-01

    Background 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. Methods and Findings 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. Conclusions Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported

  18. Scientific Opinion on the annual post-market environmental monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2013

    OpenAIRE

    Arpaia, Salvatore; Birch, Nicholas; Chesson, Andrew; du Jardin,, Patrick; Gathmann, Achim; Gropp, Jürgen; Herman, Lieve; Hoen-Sorteberg, Hilde-Gunn; Jones, Huw; Kiss, Jozsef; Kleter, Gijs; Lovik, Martinus; Messéan, Antoine; Naegeli, Hanspeter; Nielsen, Kaare Magne

    2015-01-01

    Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the post-market environmental monitoring (PMEM) report for the 2013 growing season of maize MON 810 provided by Monsanto Europe S.A. The EFSA GMO Panel concludes that the data related to insect resistance monitoring does not indicate a significant and consistent decrease in susceptibility of the target pest field populations to Cry1Ab pr...

  19. Scientific Opinion on the annual post-market environmental monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2012

    OpenAIRE

    Arpaia, Salvatore; Birch, ANE; Chesson, Andrew; du Jardin, Patrick; Gathmann, Achim; Gropp, Jürgen; Herman, Lieve; Hoen-Sorteberg, Hilde-Gunn; Jones, Huw; Kiss, József; Kleter, Gijs; Løvik, Martinus; Messean, Antoine; Naegeli, Hanspeter; Nielsen, Kåre Magne

    2014-01-01

    Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the post-market environmental monitoring (PMEM) report for the 2012 growing season of maize MON 810 provided by Monsanto Europe S.A. The EFSA GMO Panel noted that the applicant used a similar methodology as the one previously established for monitoring maize MON 810 in 2009, 2010 and 2011. The EFSA GMO Panel therefore foc...

  20. Scientific Opinion on the annual post-market environmental monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2012

    OpenAIRE

    EFSA Panel on Genetically Modified Organisms (GMO)

    2014-01-01

    Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the post-market environmental monitoring (PMEM) report for the 2012 growing season of maize MON 810 provided by Monsanto Europe S.A. The EFSA GMO Panel noted that the applicant used a similar methodology as the one previously established for monitoring maize MON 810 in 2009, 2010 and 2011. The EFSA GMO Panel therefore focused its assessm...

  1. 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

    OpenAIRE

    Petronio, Anna S; Sinning, Jan-Malte; Van Mieghem, Nicolas; Zucchelli, Giulio; Nickenig, Georg; Bekeredjian, Raffi; Bosmans, B.; Bedogni, Francesco; Branny, Marian; Stangl, Karl; Kovac, Jan; Schiltgen, Molly; Kraus, Stacia; 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, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing. Background Conduction disturbances are a frequent complication of transcatheter aortic va...

  2. ["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

  3. Scientific Opinion on the annual Post-Market Environmental Monitoring (PMEM report from BASF Plant Science Company GmbH on the cultivation of genetically modified potato EH92-527-1 in 2011

    Directory of Open Access Journals (Sweden)

    EFSA Panel on Genetically Modified Organisms (GMO

    2012-12-01

    Full Text Available Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority(EFSA GMO Panel assessed the monitoring report for the 2011 growing season, provided by BASF, on the genetically modified (GM potato EH92-527-1 (variety Amflora. On 26 January 2012, the EFSA GMO Panel had adopted a scientific opinion on the 2010 monitoring report on potato EH92-527-1. The EFSA GMO Panel followed the same approach as for the assessment of the 2010 monitoring report and assessed, in close collaboration with the EFSA Unit for Scientific Assessment Support, the methodology used by the applicant in 2011 for the case-specific studies, the general surveillance of potato EH92-527-1 and the field study to monitor potential adverse effects on potato-feeding organisms as required in the related Commission Decision. The EFSA GMO Panel notes similar shortcomings in the methodology for general surveillance and for the specific field study on potato-feeding organisms as were found in the 2010 monitoring report. Hence, the EFSA GMO Panel reiterates the same recommendations for improvement of the methodology for the post-market environmental monitoring of potato EH92-527-1 as it did in its scientific opinion on the 2010 monitoring report. The EFSA GMO Panel also assessed the methodology of a new study monitoring GM volunteers within and around fields cropped with potato EH92-527-1 in 2010. The EFSA GMO Panel identified flaws in that study and therefore makes recommendations to the applicant to improve the study design. However, from the overall dataset submitted by the applicant, the EFSA GMO Panel did not identify adverse effects on the environment or human and animal health due to potato EH92-527-1 cultivation. The outcomes of the 2011 monitoring report do not invalidate the conclusions of the EFSA GMO Panel’s previous opinions on potato EH92-527-1.

  4. Post-marketing surveillance of adverse events following immunization with inactivated quadrivalent and trivalent influenza vaccine in health care providers in Western Australia.

    Science.gov (United States)

    Regan, Annette K; Tracey, Lauren; Gibbs, Robyn

    2015-11-17

    In 2015, inactivated quadrivalent influenza vaccine (QIV) was first introduced into the Australian market. A routine vaccine safety surveillance system in Western Australia was used to conduct post-licensure surveillance of adverse events following immunization with inactivated QIV and trivalent influenza vaccines (TIV) in a sample of 1685 healthcare providers (HCPs). A similar percentage of HCPs who received QIV reported having any reaction seven days post-vaccination as HCPs who received TIV (13.6 vs. 12.8%, respectively; p=0.66). However, a slightly higher percentage of HCPs who received QIV reported pain or swelling at the injection site as compared to HCPs who received TIV (6.9% vs. 4.2%, respectively; p=0.02). No serious vaccine-associated adverse events were detected during follow-up of either vaccine. Acknowledging the study limitations, the results of this post-marketing surveillance support the safety of QIV, suggesting there is little difference in the reactogenicity of QIV as compared to TIV. PMID:26476362

  5. [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. PMID:27220801

  6. Strategy on quality evaluation of post-marketing antibiotics in China%对抗生素药品评价性抽验基本思路与方法的思考

    Institute of Scientific and Technical Information of China (English)

    胡昌勤

    2013-01-01

    Quality evaluation of post-marketing drugs in China is a key work for quality control institutes recent years. However, how to evaluate objectively the quality of domestic drugs emphasized on finding the main problem of products for improving the quality becomes an important part in this evaluation. After summarizing the evaluation results of antibiotics recent years, author expounds how to approach the common problems of post-marketing drugs by using statistical methods from routine examination data, and how to evaluate quality, manufacture process and specification of drugs by using comprehensive analysis techniques such as LC-MS methods, database technology, toxic evaluation methods for trace quantity compound and dissolution profile comparing technology etc. in exploratory study of the evaluation. The hot issues in those fields focus on impurity profiling control, dissolution/disintegration evaluation of oral preparation, compatibility of API (active pharmaceutical ingredient) with packing materials and rationality of pharmaceutical formula. The quality of post-marketing drugs in China will be improved greatly by revising drug specifications according to the evaluation results.%开展药品评价性抽验是近年来药品检验所的一项重要工作.如何客观地评价国内药品的质量现状;分析产品的主要质量问题进而明确产品质量提高的方向,是评价性抽验中亟待解决的问题.本文在对历年抗生素评价性抽验结果总结的基础上,对评价性抽验的基本思路和方法进行探讨.

  7. 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)

    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

  8. Postmarketing safety surveillance for typhoid fever vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002.

    Science.gov (United States)

    Begier, Elizabeth M; Burwen, Dale R; Haber, Penina; Ball, Robert

    2004-03-15

    Vaccines against Salmonella enterica serotype Typhi are used for prophylaxis of international travelers and have potential use as counterbioterrorism agents. The Vaccine Adverse Event Reporting System (VAERS) cannot usually establish causal relationships between vaccines and reported adverse events without further research but has successfully detected unrecognized side effects of vaccine. We reviewed reports to VAERS for US-licensed typhoid fever vaccines for the period of July 1990 through June 2002. We received 321 reports for parenteral Vi capsular polysaccharide vaccine and 345 reports for live, oral, attenuated Ty21a vaccine, with 7.5% and 5.5%, respectively, describing death, hospitalization, permanent disability, or life-threatening illness. Unexpected frequently reported symptoms included dizziness and pruritus for Vi vaccine and fatigue and myalgia for Ty21a vaccine. Gastroenteritis-like illness after receipt of Ty21a vaccine and abdominal pain after receipt of Vi vaccine, which are previously recognized events, occasionally required hospitalization. Nonfatal anaphylaxis was reported after both vaccines. VAERS reports do not indicate any unexpected serious side effects that compromise these vaccines' use for travelers' prophylaxis. PMID:14999618

  9. Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use

    Directory of Open Access Journals (Sweden)

    Plaizier-Vercammen Jacqueline

    2007-01-01

    Full Text Available Abstract Background Artemisinin-derivative formulations are now widely used to treat falciparum malaria. However, the dry powder suspensions developed for children are few and/or are of poor quality. In addition to the active compound, the presence of a suitable preservative in these medicines is essential. In this study, an evaluation of the preservative content and efficacy in some dry suspensions available on the Kenyan market was performed. Method UV spectrophotometry was used to identify the preservatives in each sample while HPLC-UV was used for quantification. After reconstitution of the powders in water, the dissolution of the preservatives was followed for 7 days. Antimicrobial efficacy of the preservatives was assessed by conducting a preservative efficacy test (PET following the European pharmacopoeia standards. Results Four different preservatives were identified namely methylparahydroxybenzoate (MP, propylparahydroxybenzoate (PP, benzoic acid and sorbic acid. MP and PP were identified in Artesiane® (artemether 300 mg/100 ml, Alaxin® (dihydroartemisinin 160 mg/80 ml andGvither ® (artemether 300 mg/100 ml respectively. Sorbic acid was presentin Artenam® (artemether 180 mg/60 ml while benzoic acid was identified in Santecxin® (dihydroartemisinin 160 mg/80 ml andArtexin® (dihydroartemisinin 160 mg/80 ml respectively. Cotecxin® (dihydroartemisinin 160 mg/80 ml did not contain any of the above preservatives. After reconstitution in water, preservativesin 50%(3/6 of the products did not completely dissolve and the PET results revealed that only Artenam® and Gvither® met the requirements for antimicrobial efficacy. The other products did not conform. Conclusion These results show that paediatric antimalarial dry powder formulations on the market may contain ineffective or incorrect amounts of preservatives. This is a potential risk to the patient. Studies conducted on the dry powder suspensions should include the analysis of both

  10. Safety profiles and efficacy of infliximab therapy in Japanese patients with plaque psoriasis with or without psoriatic arthritis, pustular psoriasis or psoriatic erythroderma: Results from the prospective post-marketing surveillance.

    Science.gov (United States)

    Torii, Hideshi; Terui, Tadashi; Matsukawa, Miyuki; Takesaki, Kazumi; Ohtsuki, Mamitaro; Nakagawa, Hidemi

    2016-07-01

    A large-scale prospective post-marketing surveillance was conducted to evaluate the safety and efficacy of infliximab in Japanese patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. This study was conducted in all psoriasis patients treated with infliximab after its Japanese regulatory approval. Infliximab was administrated at 5 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter. Patients were serially enrolled and observed for 6 months to evaluate the safety and efficacy. The safety and efficacy were evaluated in 764 and 746 patients, respectively. Incidences of any and serious adverse drug reactions were 22.51% and 6.94%, respectively, and those of any and serious infusion reactions were 6.15% and 1.31%, respectively, which were comparable with the results in the post-marketing surveillance with 5000 rheumatoid arthritis patients in Japan. Major adverse drug reactions during the follow-up period were infections (5.10%) including pneumonia, cellulitis and herpes zoster, however, no tuberculosis was observed. The safety profiles were equivalent, regardless of the psoriasis types. No new safety problems were identified. The response rates on global improvement and median improvement rate of Psoriasis Area and Severity Index in all patients were 88.0% and 85.0%, respectively. Of note, the efficacy was equivalent for each psoriasis type as well as for each body region. Infliximab was also effective in pustular psoriasis symptoms, joint symptoms and nail psoriasis, as well as improvement of quality of life. Infliximab was confirmed to be highly effective and well tolerated in treating refractory psoriasis, including pustular psoriasis and psoriatic erythroderma. PMID:26704926

  11. Scientific Opinion on the annual Post-Market Environmental Monitoring (PMEM report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2011

    Directory of Open Access Journals (Sweden)

    EFSA Panel on Genetically Modified Organisms (GMO

    2013-12-01

    Full Text Available Following the request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel assessed the monitoring report for the 2011 growing season of maize MON 810 provided by Monsanto Europe S.A. The EFSA GMO Panel already assessed the 2009 and 2010 monitoring reports and followed the same approach as for the assessment of the methodology applied by the applicant for monitoring maize MON 810 in 2011. The EFSA GMO Panel considered the plan for insect-resistant management and addressed the comments raised by the applicant on its previous recommendations for improving the methodology of the resistance monitoring of target pests. The EFSA GMO Panel also paid particular attention to the design and analysis of the farmer questionnaires. The EFSA GMO Panel notes similar shortcomings in the overall methodology for the post-market environmental monitoring of maize MON 810 as in the previous monitoring reports. Hence, while the EFSA GMO Panel reiterates its previous recommendations for the improvement of the methodology, it also clarifies and elaborates on those related to the monitoring of resistance evolution in target pests. However, from the data submitted by the applicant, the EFSA GMO Panel does not identify adverse effects on the environment, human and animal health due to maize MON 810 cultivation during the 2011 growing season. The outcomes of the 2011 monitoring report do not invalidate the previous EFSA GMO Panel’s scientific opinions on maize MON 810.

  12. Scientific Opinion on the annual post-market environmental monitoring (PMEM report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2012

    Directory of Open Access Journals (Sweden)

    EFSA Panel on Genetically Modified Organisms (GMO

    2014-06-01

    Full Text Available Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel assessed the post-market environmental monitoring (PMEM report for the 2012 growing season of maize MON 810 provided by Monsanto Europe S.A. The EFSA GMO Panel noted that the applicant used a similar methodology as the one previously established for monitoring maize MON 810 in 2009, 2010 and 2011. The EFSA GMO Panel therefore focused its assessment on the novel datasets specific to the 2012 growing season of maize MON 810, and not on the methodology. The data submitted by the applicant in its 2012 PMEM report do not indicate any adverse effects on human and animal health or the environment arising from maize MON 810 cultivation in 2012. However, having already highlighted the poor sensitivity of the methodology followed by the applicant, the EFSA GMO Panel strongly reiterates its previous recommendations for the improvement of the methodology. In addition, the EFSA GMO Panel recommends that the applicant: (1 further investigates effects observed during the monitoring of baseline susceptibility of target pests in Spain; (2 follow-up possible adverse effects of maize MON 810 on rove beetles.

  13. Eligibility Requirements

    Science.gov (United States)

    ... Home > Donating Blood > Eligibility Requirements Printable Version Eligibility Requirements This page uses Javascript. Your browser either doesn' ... donors » Weigh at least 110 lbs. Additional weight requirements apply for donors 18-years-old and younger ...

  14. Quality-control for post-marketing drug reevaluation: current situation analysis and process management in patient recruitment%药品上市后临床试验的质量控制:病例募集的现状分析与过程管理

    Institute of Scientific and Technical Information of China (English)

    曹红波; 商洪才

    2013-01-01

    病例募集是临床试验尤其是药品上市后临床试验质量控制的关键环节,直接关系到试验的成败及其结果的可信度.本文就目前药品上市后临床试验病例募集的现状、存在问题、影响因素和募集过程的管理等作一阐述,以期为未来的上市后临床研究提供参考和借鉴.%Patient recruitment is important for clinical trials of post-marketing drugs because its quality relates to the success and reliability of clinical trial result.This article will elaborate the present situation, influence factors and process management on patient recruitment in order to provide references for the clinical trials of post-marketing drugs in the future.

  15. Software requirements

    CERN Document Server

    Wiegers, Karl E

    2003-01-01

    Without formal, verifiable software requirements-and an effective system for managing them-the programs that developers think they've agreed to build often will not be the same products their customers are expecting. In SOFTWARE REQUIREMENTS, Second Edition, requirements engineering authority Karl Wiegers amplifies the best practices presented in his original award-winning text?now a mainstay for anyone participating in the software development process. In this book, you'll discover effective techniques for managing the requirements engineering process all the way through the development cy

  16. 基于循证药学的悦安欣苦碟子注射液上市后安全性研究%A Post-marketing Safety Research of Kudiezi Injection from Evidence-based Pharmacy

    Institute of Scientific and Technical Information of China (English)

    黎元元; 李志强; 谢雁鸣

    2014-01-01

    In order to ensure safety and efficacy of Yueanxin Kudiezi Injection (referred to as KDI)we launched a comprehensive re-search ranging from production,quality control,pharmacology,to post-market safety evaluation etc.The results showed KDI was strictly QC’ed from GAP to the production process.No adverse reaction was shown in acute toxicity test,long-term toxicity test,and phase III clinical study for treatment of coronary heart disease and cerebral thrombosis;KDI was approved to be effective and safe in a random-ized,double-blind,positive controlled,multi center clinical trials for treatment of coronary disease angina pectoris (blood stasis syn-drome)and stroke (cerebral infarction);691 cases reported in SRS,PRR method and BCPNN method displayed,headache is warning signal of ADR;Our research results provided safety information of KDI for clinical use,scientific research and production.%为确保悦安欣苦碟子注射液(简称苦碟子注射液)临床应用安全有效,本研究根据《中药注射剂安全性再评价生产工艺评价等7个技术指导原则》,对苦碟子注射液的上市后研究开展系统梳理,包括生产工艺、质量控制、药理毒理、上市后临床研究、前瞻性的临床安全性医院集中监测、基于国家药品不良反应(ADR)监测中心提供的自发呈报系统(SRS)数据分析、文献研究等多方面。结果显示:苦碟子注射液从 GAP 到生产过程药品质量严格控制。急性毒性试验、长期毒性试验、特殊毒理学未见不良反应;上市前治疗冠心病和脑血栓的Ⅲ期临床研究未见明显不良反应;上市后治疗冠心病心绞痛(心血瘀阻证)和中风(脑梗死)恢复期的有效性和安全性的随机、仿盲、阳性药平行对照、多中心临床试验表明安全有效;近3年 SRS691例 ADR 报告, PRR 法和 BCPNN 法显示,头痛、头晕是 ADR 预警信号;通过这一系列的研究荟萃,形成

  17. 浅析美国FDA对医疗器械上市后监测的信息化手段及其启示%Informational Methods Used for Medical Devices Post-marketing Surveillance by FDA and Its Inspiration

    Institute of Scientific and Technical Information of China (English)

    费晓璐; 魏岚

    2011-01-01

    The information system used for the medical devices post-marketing surveillance and the information service provided to the public performed by the U.S.A. Food and Drug Administration (FDA) are studied. The data source and application characteristics of Manufacturer and User Facility Device Experience (MAUDE) are also investigated. Combining the research results and the current condition in China suggestion about the system structure is presented about establishing the voluntary repmting system and the comprehensive datahase for the adverse events with uniform standards in China.[Chinese Medical Equipment Journal, 2011 , 32 ( 5) ; 78-79 , 87]%研究美国食品与药品管理局(FDA)对医疗器械上市后监测所采用的信息系统以及其为公众提供的信息服务手段,探讨美国医疗器械不良反应监测的基础数据库--厂商和用户使用设备体验数据库(MAUDE)的数据来源及各种应用特点.根据研究结果并结合国内实际情况,对国家建设符合规范的自发报告系统及综合数据库提出内容和结构上的建议.

  18. Requirement Elicitation for Requirement in Software Engineering

    OpenAIRE

    Swathine.K*; Dr. J.KomalaLakshmi

    2014-01-01

    Requirement Elicitation is also called as Requirement Gathering, in which requirements are collected from User, Stakeholders, and Customer to build the system. Requirements elicitation practices include interviews, questionnaires, task analysis, domain analysis, user observation, workshops, brainstorming, use cases, role playing and prototyping by using this practices quality of the requirements are satisfied. A wide variety of tools exist that have been developed and used to supp...

  19. Reduced dose human papillomavirus vaccination: an update of the current state-of-the-art.

    Science.gov (United States)

    Toh, Zheng Quan; Licciardi, Paul V; Fong, James; Garland, Suzanne M; Tabrizi, Sepehr N; Russell, Fiona M; Mulholland, Edward K

    2015-09-22

    Human papillomavirus (HPV) infection is the primary cause of genital warts, some oropharyngeal cancers and anogenital cancers, including cervical, vagina, vulvar, anal and penile cancers. Primary prevention of cervical cancer requires the prevention of high-risk HPV infections, particularly HPV genotypes 16 and 18. Both Gardasil® and Cervarix® vaccines when administered by a three-dose schedule have been demonstrated to be effective against cervical, vulva, and vaginal cancer precursors from vaccine genotypes in phase III clinical trials, and post-marketing studies; Gardasil® vaccine also offers additional protection against anal cancer precursors. However, high costs of HPV vaccines and the logistics of delivering a three-dose schedule over 6 months are challenging in countries with limited resources. Several studies have demonstrated non-inferiority in antibody response between adolescents (9-15 years old) who received two doses (6 months apart) and women (>15 years old) who received the standard three-dose schedule. These studies provided evidence for the World Health Organization and European Medical Association to revise its recommendation to give two instead of three doses of HPV vaccine to adolescents below 15 years of age, provided the 2nd dose is given 6 months apart. Although reduced dose schedules can alleviate costs and logistics associated with HPV vaccination, especially in resource-poor countries, there are still gaps in this area of research, particularly regarding long-term protection. This review discusses the findings on antibody response and clinical outcomes in studies evaluating reduced dose HPV schedules, and highlights the important considerations of its implementation. In addition, other important immunological biomarkers that may be associated with long-term protection are highlighted and discussed. PMID:26271829

  20. Groupware requirements evolution patterns

    NARCIS (Netherlands)

    Pumareja, Dulce Trinidad

    2013-01-01

    Requirements evolution is a generally known problem in software development. Requirements are known to change all throughout a system's lifecycle. Nevertheless, requirements evolution is a poorly understood phenomenon. Most studies on requirements evolution focus on changes to written specifications

  1. Practice of Post-marketing Safety Reevaluation of Salvianolate and Other TCM Injections in Our Hospital%我院开展丹参多酚酸盐等中药注射剂上市后安全性再评价的实践Δ

    Institute of Scientific and Technical Information of China (English)

    吕世文; 郭佳奕; 朱亚兰

    2015-01-01

    OBJECTIVE:To explore the idea and method of post-marketing safety reevaluation of TCM injection in our hospi-tal. METHODS:In case-control study,salvianolate for injection was chosen for practice. 1 000 patients with stable angina receiv-ing Salvianolate for injection in our hospital during May 2012-Oct. 2013 were selected as subjects. The occurrence of ADR/ADE were observed and Logistic regression analysis was conducted by using SPSS 20.0 software. RESULTS:The incidence of ADR/ADE was 0.6%,and rare(0.1%-1%). The ADR/ADE were general and mainly manifested as erythra(66.67%). Skin and its ap-pendants were main organs involved in ADR(66.67%). Logistic regression analysis showed that gender,drug combination and age are risk factors of ADR/ADE. CONCLUSIONS:The post-marketing safety reevaluation of TCM injection not only make up for the deficiency of pre-marketing safety evaluation of TCM injection and find out potential delayed and severe ADR/ADE and drug inter-action,but also provide reference for rational drug use in the clinic and guarantee the safe and rational drug use.%目的:探索我院开展中药注射剂上市后安全性再评价的研究思路与方法。方法:采用队列内病例-对照研究,以注射用丹参多酚酸盐为例进行实践。选取我院2012年5月至2013年10月1000例使用注射用丹参多酚酸盐的冠心病稳定性心绞痛患者为研究对列,观察其不良反应/不良事件(ADR/ADE)的发生情况,结果采用SPSS 20.0软件进行Logistic回归分析。结果:患者的ADR/ADE发生率为0.6%,均为偶见(0.1%~1%),级别为“一般”,主要表现为皮疹(66.67%),主要累及器官为皮肤及其附件(66.67%);经Logistic回归分析显示,性别、合并用药、年龄是ADR/ADE发生的危险因素。结论:对中药注射剂进行上市后安全性再评价,不仅弥补了中药注射剂在药品上市前评价的不足,发现可能存

  2. Feed tank transfer requirements

    International Nuclear Information System (INIS)

    This document presents a definition of tank turnover; DOE responsibilities; TWRS DST permitting requirements; TWRS Authorization Basis (AB) requirements; TWRS AP Tank Farm operational requirements; unreviewed safety question (USQ) requirements; records and reporting requirements, and documentation which will require revision in support of transferring a DST in AP Tank Farm to a privatization contractor for use during Phase 1B

  3. CLINICAL STUDIES IN COMMON WEALTH INDEPENDENT STATES: CRITICAL ASSESSMENT OF THE REGULATORY REQUIREMENTS

    Directory of Open Access Journals (Sweden)

    SURESH KR

    2014-06-01

    Full Text Available This study provides the outcome of the survey carried out with the representatives of competent authorities and research industry, where they share opinions on the regulatory frameworks and experience in these countries. Duration of the study approval as per legislation of Russia and Kazakhstan corresponds to 7 and 33 weeks respectively. In Moldova and Belarus duration of the approval procedure is not fixed by the legislation, however according to the industry reports Moldova has the shortest approval times (4 weeks on average, and in Belarus it takes from 4 to 12 weeks to approve the study. The reviewed legislations of all four countries lacks proper description of the procedures carried out after the study approval, such as notification of amendments, submission of progress and final study reports, notification of adverse events and the end of the study. A number of regulatory concepts are not defined in the legislation: orphan drug (absent in Moldova, Belarus, observational study (absent all countries, post-marketing study (absent in Belarus, Kazakhstan, Moldova, substantial and non-substantial amendment (absent in all countries, etc. In the survey the industry representatives have identified two main challenges for clinical research true for all countries: customs regulations and cultural perceptions to clinical research. Areas of improvements in the national regulatory systems, identified by the representatives of the competent authorities, included poor requirements to health insurance for study subjects (Moldova, Belarus, non-harmonized standards on training of investigators and accreditation of the ECs (Kazakhstan, Moldova and poor quality of the study site inspections (Kazakhstan.

  4. Framework for Requirements Traceability

    OpenAIRE

    Raja, Uzair Akbar; Kamran, Kashif

    2008-01-01

    Requirements traceability provides support for many software engineering activities like impact analysis, requirements validation and regression testing. In addition requirements traceability is the recognized component of many software process improvement initiatives. Requirements traceability also helps to control and manage evolution of a software system. This thesis presents a systematic review and a framework for requirements traceability. The systematic review is aimed at presenting fai...

  5. Feed tank transfer requirements

    International Nuclear Information System (INIS)

    This document presents a definition of tank turnover. Also, DOE and PC responsibilities; TWRS DST permitting requirements; TWRS Authorization Basis (AB) requirements; TWRS AP Tank Farm operational requirements; unreviewed safety question (USQ) requirements are presented for two cases (i.e., tank modifications occurring before tank turnover and tank modification occurring after tank turnover). Finally, records and reporting requirements, and documentation which will require revision in support of transferring a DST in AP Tank Farm to a privatization contractor are presented

  6. Discovering system requirements

    Energy Technology Data Exchange (ETDEWEB)

    Bahill, A.T.; Bentz, B. [Univ. of Arizona, Tucson, AZ (United States). Systems and Industrial Engineering; Dean, F.F. [Sandia National Labs., Albuquerque, NM (United States)

    1996-07-01

    Cost and schedule overruns are often caused by poor requirements that are produced by people who do not understand the requirements process. This report provides a high-level overview of the system requirements process, explaining types, sources, and characteristics of good requirements. System requirements, however, are seldom stated by the customer. Therefore, this report shows ways to help you work with your customer to discover the system requirements. It also explains terminology commonly used in the requirements development field, such as verification, validation, technical performance measures, and the various design reviews.

  7. Groupware requirements evolution patterns

    OpenAIRE

    Pumareja, Dulce Trinidad

    2013-01-01

    Requirements evolution is a generally known problem in software development. Requirements are known to change all throughout a system's lifecycle. Nevertheless, requirements evolution is a poorly understood phenomenon. Most studies on requirements evolution focus on changes to written specifications and on software architecture and design. Usually, the focus is when the software is under development. Little is known about how requirements evolve when software is put into use. Groupware is an ...

  8. REQUIREMENT ENGINEERING: A REVIEW

    OpenAIRE

    Bhawna; Sanjay Kumar; Amita Dhankar

    2012-01-01

    Requirement Engineering acts as foundation for any software and is one of the most important tasks. Entire software is supported by four pillars of requirement engineering processes. Goal-oriented requirements engineering is concerned with the use of goals for eliciting, elaborating, structuring, specifying, analyzing, negotiating, documenting, and modifying requirements. This areahas received increasing attention over the past few years.The paper has highlighted requirement engineering chall...

  9. Ontology Requirements Specification

    OpenAIRE

    Suárez-Figueroa, Mari Carmen; A. GÓMEZ-PÉREZ

    2012-01-01

    The goal of the ontology requirements specification activity is to state why the ontology is being built, what its intended uses are, who the end users are, and which requirements the ontology should fulfill. This chapter presents detailed methodological guidelines for specifying ontology requirements efficiently. These guidelines will help ontology engineers to capture ontology requirements and produce the ontology requirements specification document (ORSD). The ORSD will play a key role dur...

  10. Assessing Requirements Quality through Requirements Coverage

    Science.gov (United States)

    Rajan, Ajitha; Heimdahl, Mats; Woodham, Kurt

    2008-01-01

    In model-based development, the development effort is centered around a formal description of the proposed software system the model. This model is derived from some high-level requirements describing the expected behavior of the software. For validation and verification purposes, this model can then be subjected to various types of analysis, for example, completeness and consistency analysis [6], model checking [3], theorem proving [1], and test-case generation [4, 7]. This development paradigm is making rapid inroads in certain industries, e.g., automotive, avionics, space applications, and medical technology. This shift towards model-based development naturally leads to changes in the verification and validation (V&V) process. The model validation problem determining that the model accurately captures the customer's high-level requirements has received little attention and the sufficiency of the validation activities has been largely determined through ad-hoc methods. Since the model serves as the central artifact, its correctness with respect to the users needs is absolutely crucial. In our investigation, we attempt to answer the following two questions with respect to validation (1) Are the requirements sufficiently defined for the system? and (2) How well does the model implement the behaviors specified by the requirements? The second question can be addressed using formal verification. Nevertheless, the size and complexity of many industrial systems make formal verification infeasible even if we have a formal model and formalized requirements. Thus, presently, there is no objective way of answering these two questions. To this end, we propose an approach based on testing that, when given a set of formal requirements, explores the relationship between requirements-based structural test-adequacy coverage and model-based structural test-adequacy coverage. The proposed technique uses requirements coverage metrics defined in [9] on formal high-level software

  11. Requirements for existing buildings

    DEFF Research Database (Denmark)

    Thomsen, Kirsten Engelund; Wittchen, Kim Bjarne

    2012-01-01

    This report collects energy performance requirements for existing buildings in European member states by June 2012.......This report collects energy performance requirements for existing buildings in European member states by June 2012....

  12. Obsolete Software Requirements

    OpenAIRE

    Zahda, Showayb

    2011-01-01

    Context. Requirements changes are unavoidable in any software project. Requirements change over time as software projects progress, and involved stakeholders (mainly customers) and developers gain better understanding of the final product. Additionally, time and budget constraints prevent implementing all candidate requirements and force project management to select a subset of requirements that are prioritized more important than the others so as to be implemented. As a result, some requirem...

  13. Future Home Network Requirements

    DEFF Research Database (Denmark)

    Charbonnier, Benoit; Wessing, Henrik; Lannoo, Bart;

    This paper presents the requirements for future Home Area Networks (HAN). Firstly, we discuss the applications and services as well as their requirements. Then, usage scenarios are devised to establish a first specification for the HAN. The main requirements are an increased bandwidth (towards 1...

  14. PIT Coating Requirements Analysis

    Energy Technology Data Exchange (ETDEWEB)

    MINTEER, D.J.

    2000-10-20

    This study identifies the applicable requirements for procurement and installation of a coating intended for tank farm valve and pump pit interior surfaces. These requirements are intended to be incorporated into project specification documents and design media. This study also evaluates previously recommended coatings and identifies requirement-compliant coating products.

  15. PIT Coating Requirements Analysis

    International Nuclear Information System (INIS)

    This study identifies the applicable requirements for procurement and installation of a coating intended for tank farm valve and pump pit interior surfaces. These requirements are intended to be incorporated into project specification documents and design media. This study also evaluates previously recommended coatings and identifies requirement-compliant coating products

  16. Transportation System Requirements Document

    Energy Technology Data Exchange (ETDEWEB)

    1993-09-01

    This Transportation System Requirements Document (Trans-SRD) describes the functions to be performed by and the technical requirements for the Transportation System to transport spent nuclear fuel (SNF) and high-level radioactive waste (HLW) from Purchaser and Producer sites to a Civilian Radioactive Waste Management System (CRWMS) site, and between CRWMS sites. The purpose of this document is to define the system-level requirements for Transportation consistent with the CRWMS Requirement Document (CRD). These requirements include design and operations requirements to the extent they impact on the development of the physical segments of Transportation. The document also presents an overall description of Transportation, its functions, its segments, and the requirements allocated to the segments and the system-level interfaces with Transportation. The interface identification and description are published in the CRWMS Interface Specification.

  17. Transportation System Requirements Document

    International Nuclear Information System (INIS)

    This Transportation System Requirements Document (Trans-SRD) describes the functions to be performed by and the technical requirements for the Transportation System to transport spent nuclear fuel (SNF) and high-level radioactive waste (HLW) from Purchaser and Producer sites to a Civilian Radioactive Waste Management System (CRWMS) site, and between CRWMS sites. The purpose of this document is to define the system-level requirements for Transportation consistent with the CRWMS Requirement Document (CRD). These requirements include design and operations requirements to the extent they impact on the development of the physical segments of Transportation. The document also presents an overall description of Transportation, its functions, its segments, and the requirements allocated to the segments and the system-level interfaces with Transportation. The interface identification and description are published in the CRWMS Interface Specification

  18. Software Requirements Management

    Directory of Open Access Journals (Sweden)

    Ali Altalbe

    2015-04-01

    Full Text Available Requirements are defined as the desired set of characteristics of a product or a service. In the world of software development, it is estimated that more than half of the failures are attributed towards poor requirements management. This means that although the software functions correctly, it is not what the client requested. Modern software requirements management methodologies are available to reduce the occur-rence of such incidents. This paper performs a review on the available literature in the area while tabulating possible methods of managing requirements. It also highlights the benefits of following a proper guideline for the requirements management task. With the introduction of specific software tools for the requirements management task, better software products are now been developed with lesser resources.

  19. Testing Agile Requirements Models

    OpenAIRE

    Botaschanjan, Jewgenij; Pister, Markus; Rumpe, Bernhard

    2014-01-01

    This paper discusses a model-based approach to validate software requirements in agile development processes by simulation and in particular automated testing. The use of models as central development artifact needs to be added to the portfolio of software engineering techniques, to further increase efficiency and flexibility of the development beginning already early in the requirements definition phase. Testing requirements are some of the most important techniques to give feedback and to i...

  20. Software Requirements Management

    OpenAIRE

    Ali Altalbe

    2015-01-01

    Requirements are defined as the desired set of characteristics of a product or a service. In the world of software development, it is estimated that more than half of the failures are attributed towards poor requirements management. This means that although the software functions correctly, it is not what the client requested. Modern software requirements management methodologies are available to reduce the occur-rence of such incidents. This paper performs a review on the available literatur...

  1. Anthropometric Requirements for Constellation

    Science.gov (United States)

    Raulu, Sudhakar; Margerum, Sarah; Dory, Jonathan; Rochlis, Jennifer

    2009-01-01

    This slide presentation reviews the requirement from an Anthropometric standpoint for the development of the Constellation's programs hardware, specifically the Orion crew exploration vehicle. The NASA JSC Anthropometry and Biomechanics Facility (ABF) provides anthropometry, strength, mobility, and mass properties requirements; gathers, interprets, manages and maintains the flight crew anthropometry database; and participates and provides input during crew selection. This is used to assist in requirements for vehicle and space suit design and for crew selection.

  2. Testing agile requirements models

    Institute of Scientific and Technical Information of China (English)

    BOTASCHANJAN Jewgenij; PISTER Markus; RUMPE Bernhard

    2004-01-01

    This paper discusses a model-based approach to validate software requirements in agile development processes by simulation and in particular automated testing. The use of models as central development artifact needs to be added to the portfolio of software engineering techniques, to further increase efficiency and flexibility of the development beginning already early in the requirements definition phase. Testing requirements are some of the most important techniques to give feedback and to increase the quality of the result. Therefore testing of artifacts should be introduced as early as possible, even in the requirements definition phase.

  3. Environmental Requirements Management

    Energy Technology Data Exchange (ETDEWEB)

    Cusack, Laura J.; Bramson, Jeffrey E.; Archuleta, Jose A.; Frey, Jeffrey A.

    2015-01-08

    CH2M HILL Plateau Remediation Company (CH2M HILL) is the U.S. Department of Energy (DOE) prime contractor responsible for the environmental cleanup of the Hanford Site Central Plateau. As part of this responsibility, the CH2M HILL is faced with the task of complying with thousands of environmental requirements which originate from over 200 federal, state, and local laws and regulations, DOE Orders, waste management and effluent discharge permits, Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) response and Resource Conservation and Recovery Act (RCRA) corrective action documents, and official regulatory agency correspondence. The challenge is to manage this vast number of requirements to ensure they are appropriately and effectively integrated into CH2M HILL operations. Ensuring compliance with a large number of environmental requirements relies on an organization’s ability to identify, evaluate, communicate, and verify those requirements. To ensure that compliance is maintained, all changes need to be tracked. The CH2M HILL identified that the existing system used to manage environmental requirements was difficult to maintain and that improvements should be made to increase functionality. CH2M HILL established an environmental requirements management procedure and tools to assure that all environmental requirements are effectively and efficiently managed. Having a complete and accurate set of environmental requirements applicable to CH2M HILL operations will promote a more efficient approach to: • Communicating requirements • Planning work • Maintaining work controls • Maintaining compliance

  4. Strategies for postmarketing surveillance of drugs for rare diseases.

    Science.gov (United States)

    Kesselheim, A S; Gagne, J J

    2014-03-01

    Rare diseases are an important part of the public health, affecting 6-8% of the population, and drugs intended for rare diseases comprise the fastest growing subcategory of new drug approvals in the United States. However, clinical study of therapeutics in these populations is limited by the low prevalence of these diseases, and the natural history or pathogenesis of the disease may be poorly described. In addition, commonly used strategies for evaluation of postapproval safety and effectiveness, such as meta-analyses and review of spontaneous adverse event reports, may not be applicable. Alternative methodological approaches, including natural history studies, adaptive clinical trial designs, and epidemiological studies using patient-organized registries, show substantial promise for the study of rare disease therapeutics. Bayesian trials and distributed networks of large electronic databases are the most promising strategies for active and prospective monitoring of clinical interventions for rare diseases. PMID:24193169

  5. Informatic Tools and Approaches in Postmarketing Pharmacovigilance Used by FDA

    OpenAIRE

    Weaver, Joyce; Willy, Mary; Avigan, Mark

    2008-01-01

    The safety profile of newly approved drugs and therapeutic biologics is less well developed by pre-marketing clinical testing than is the efficacy profile. The full safety profile of an approved product is established during years of clinical use. For nearly 40 years, the FDA has relied on the voluntary reporting of adverse events by healthcare practitioners and patients to help establish the safety of marketed products. Epidemiologic studies, including case series, secular trends, case-contr...

  6. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Science.gov (United States)

    2010-04-01

    ... Evaluation and Research (see mailing addresses in § 600.2). Submit all vaccine adverse experience reports to: Vaccine Adverse Event Reporting System (VAERS) (see mailing addresses in § 600.2). FDA may waive the... history of actions taken since the last report because of adverse experiences (for example,...

  7. User Requirements for Wireless

    DEFF Research Database (Denmark)

    huge problems with the final product. The elicitation of user requirements as such changes according to age groups;, to gender,; to cultural settings,; and into time; and experience in the use of the system/software. User requirements, therefore, cannot be used between projects, IT systems, and...

  8. Writing testable software requirements

    Energy Technology Data Exchange (ETDEWEB)

    Knirk, D. [Sandia National Labs., Albuquerque, NM (United States)

    1997-11-01

    This tutorial identifies common problems in analyzing requirements in the problem and constructing a written specification of what the software is to do. It deals with two main problem areas: identifying and describing problem requirements, and analyzing and describing behavior specifications.

  9. Requirements in engineering projects

    CERN Document Server

    Fernandes, João M

    2016-01-01

    This book focuses on various topics related to engineering and management of requirements, in particular elicitation, negotiation, prioritisation, and documentation (whether with natural languages or with graphical models). The book provides methods and techniques that help to characterise, in a systematic manner, the requirements of the intended engineering system.  It was written with the goal of being adopted as the main text for courses on requirements engineering, or as a strong reference to the topics of requirements in courses with a broader scope. It can also be used in vocational courses, for professionals interested in the software and information systems domain.   Readers who have finished this book will be able to: - establish and plan a requirements engineering process within the development of complex engineering systems; - define and identify the types of relevant requirements in engineering projects; - choose and apply the most appropriate techniques to elicit the requirements of a giv...

  10. Creativity in Requirement Identification

    DEFF Research Database (Denmark)

    Sørensen, Lene Tolstrup; Olesen, Henning

    Traditional requirements engineering focuses mainly on analysis and elicitation. However, current trends in new system, device and software are towards involving all stakeholders in the early stages of the engineering process to define the user requirements. Creativity is here seen as a major...... keystone in this process in order to open up stakeholder's mind to new technologies, which do not yet exist. This paper dis-cusses the application of creativity in the requirements process and illustrate through cases from the MAGNET and MAGNET Beyond projects....

  11. Requirements engineering through viewpoints

    OpenAIRE

    Finkelstein, A.; S. Easterbrook; Kramer, J.; Nuseibeh, B.

    1993-01-01

    This paper provides a short review of contributions to a better understanding of requirements engineering arising from research at Imperial College. These contributions share a common theme - a focus on “multiple perspectives” or viewpoints.

  12. TWRSview system requirements specification

    International Nuclear Information System (INIS)

    This document provides the system requirements specification for the TWRSview software system. The TWRSview software system is being developed to integrate electronic data supporting the development of the TWRS technical baseline

  13. Requirements management and control

    Science.gov (United States)

    Robbins, Red

    1993-01-01

    The systems engineering process for thermal nuclear propulsion requirements and configuration definition is described in outline and graphic form. Functional analysis and mission attributes for a Mars exploration mission are also addressed.

  14. Utility requirements for fusion

    International Nuclear Information System (INIS)

    This report describes work done and results obtained during performance of Task 1 of a study of Utility Requirements and Criteria for Fusion Options. The work consisted of developing a list of utility requirements for fusion optics containing definition of the requirements and showing their relative importance to the utility industry. The project team members developed a preliminary list which was refined by discussions and literature searches. The refined list was recast as a questionnaire which was sent to a substantial portion of the utility industry in this country. Forty-three questionnaire recipients responded including thirty-two utilities. A workshop was held to develop a revised requirements list using the survey responses as a major input. The list prepared by the workshop was further refined by a panel consisting of vice presidents of the three project team firms. The results of the study indicate that in addition to considering the cost of energy for a power plant, utilities consider twenty-three other requirements. Four of the requirements were judged to be vital to plant acceptability: Plant Capital Cost, Financial Liability, Plant Safety and Licensability

  15. NP Science Network Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Dart, Eli [Lawrence Berkeley National Laboratory (LBNL), Berkeley, CA (United States); Rotman, Lauren [Lawrence Berkeley National Laboratory (LBNL), Berkeley, CA (United States); Tierney, Brian [Lawrence Berkeley National Laboratory (LBNL), Berkeley, CA (United States)

    2011-08-26

    The Energy Sciences Network (ESnet) is the primary provider of network connectivity for the U.S. Department of Energy (DOE) Office of Science (SC), the single largest supporter of basic research in the physical sciences in the United States. To support SC programs, ESnet regularly updates and refreshes its understanding of the networking requirements of the instruments, facilities, scientists, and science programs it serves. This focus has helped ESnet to be a highly successful enabler of scientific discovery for over 20 years. In August 2011, ESnet and the Office of Nuclear Physics (NP), of the DOE SC, organized a workshop to characterize the networking requirements of the programs funded by NP. The requirements identified at the workshop are summarized in the Findings section, and are described in more detail in the body of the report.

  16. Entrepreneurial learning requires action

    DEFF Research Database (Denmark)

    Brink, Tove; Madsen, Svend Ole

    2014-01-01

    This paper reveals how managers of small- and medium-sized enterprises (SMEs) can utilise their participation in research-based training. Empirical research from a longitudinal study of 10 SMEs managers in the wind turbine industry is provided to describe a learning approach that SME managers can...... that is enhanced by essential large-scale industry players and other SME managers are required to create action and value in learning. An open-mindedness to new learning approaches by SME managers and an open-mindedness to multi- and cross-disciplinary collaboration with SME managers by facilitators is required....

  17. Requirements for Xenon International

    Energy Technology Data Exchange (ETDEWEB)

    Hayes, James C.; Ely, James H.; Haas, Derek A.; Harper, Warren W.; Heimbigner, Tom R.; Hubbard, Charles W.; Humble, Paul H.; Madison, Jill C.; Morris, Scott J.; Panisko, Mark E.; Ripplinger, Mike D.; Stewart, Timothy L.

    2015-12-30

    This document defines the requirements for the new Xenon International radioxenon system. The output of this project will be a Pacific Northwest National Laboratory (PNNL) developed prototype and a manufacturer-developed production prototype. The two prototypes are intended to be as close to matching as possible; this will be facilitated by overlapping development cycles and open communication between PNNL and the manufacturer.

  18. Ecodesign requirements for televisions

    DEFF Research Database (Denmark)

    Huulgaard, Rikke Dorothea; Dalgaard, Randi; Merciai, Stefano

    2013-01-01

    phase. This is not in line with the scientific understanding of ecodesign, where attention should be put on all life cycle phases and all relevant environmental impact categories. This study focuses on the requirements for televisions (TV). A life cycle assessment (LCA) is carried out on two TVs to...

  19. Data Crosscutting Requirements Review

    Energy Technology Data Exchange (ETDEWEB)

    Kleese van Dam, Kerstin [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Shoshani, Arie [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Plata, Charity [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2013-04-01

    In April 2013, a diverse group of researchers from the U.S. Department of Energy (DOE) scientific community assembled to assess data requirements associated with DOE-sponsored scientific facilities and large-scale experiments. Participants in the review included facilities staff, program managers, and scientific experts from the offices of Basic Energy Sciences, Biological and Environmental Research, High Energy Physics, and Advanced Scientific Computing Research. As part of the meeting, review participants discussed key issues associated with three distinct aspects of the data challenge: 1) processing, 2) management, and 3) analysis. These discussions identified commonalities and differences among the needs of varied scientific communities. They also helped to articulate gaps between current approaches and future needs, as well as the research advances that will be required to close these gaps. Moreover, the review provided a rare opportunity for experts from across the Office of Science to learn about their collective expertise, challenges, and opportunities. The "Data Crosscutting Requirements Review" generated specific findings and recommendations for addressing large-scale data crosscutting requirements.

  20. Protein Requirements during Aging.

    Science.gov (United States)

    Courtney-Martin, Glenda; Ball, Ronald O; Pencharz, Paul B; Elango, Rajavel

    2016-01-01

    Protein recommendations for elderly, both men and women, are based on nitrogen balance studies. They are set at 0.66 and 0.8 g/kg/day as the estimated average requirement (EAR) and recommended dietary allowance (RDA), respectively, similar to young adults. This recommendation is based on single linear regression of available nitrogen balance data obtained at test protein intakes close to or below zero balance. Using the indicator amino acid oxidation (IAAO) method, we estimated the protein requirement in young adults and in both elderly men and women to be 0.9 and 1.2 g/kg/day as the EAR and RDA, respectively. This suggests that there is no difference in requirement on a gender basis or on a per kg body weight basis between younger and older adults. The requirement estimates however are ~40% higher than the current protein recommendations on a body weight basis. They are also 40% higher than our estimates in young men when calculated on the basis of fat free mass. Thus, current recommendations may need to be re-assessed. Potential rationale for this difference includes a decreased sensitivity to dietary amino acids and increased insulin resistance in the elderly compared with younger individuals. PMID:27529275

  1. Protein Requirements during Aging

    Directory of Open Access Journals (Sweden)

    Glenda Courtney-Martin

    2016-08-01

    Full Text Available Protein recommendations for elderly, both men and women, are based on nitrogen balance studies. They are set at 0.66 and 0.8 g/kg/day as the estimated average requirement (EAR and recommended dietary allowance (RDA, respectively, similar to young adults. This recommendation is based on single linear regression of available nitrogen balance data obtained at test protein intakes close to or below zero balance. Using the indicator amino acid oxidation (IAAO method, we estimated the protein requirement in young adults and in both elderly men and women to be 0.9 and 1.2 g/kg/day as the EAR and RDA, respectively. This suggests that there is no difference in requirement on a gender basis or on a per kg body weight basis between younger and older adults. The requirement estimates however are ~40% higher than the current protein recommendations on a body weight basis. They are also 40% higher than our estimates in young men when calculated on the basis of fat free mass. Thus, current recommendations may need to be re-assessed. Potential rationale for this difference includes a decreased sensitivity to dietary amino acids and increased insulin resistance in the elderly compared with younger individuals.

  2. Required High School Internships

    Science.gov (United States)

    Graham, Kate; Morrow, Jennifer

    2013-01-01

    Through a literature review, and in the words of internees, this article describes the value of required internship for career growth. It notes that an internship experience ensures that students have a mentor who can be a professional reference, having actually witnessed what Mojkowski and Washor call the students' "non-academic"…

  3. 78 FR 67168 - Sixth Annual Sentinel Initiative; Public Workshop

    Science.gov (United States)

    2013-11-08

    ..., postmarketing requirements (PMRs), or postmarketing commitments (PMCs)). This workshop satisfies an FDA.... For additional travel and hotel information, please refer to http://www.cvent.com/d/jcqhyy . (FDA has... restaurants within walking distance of the hotel. If you need special accommodations due to a...

  4. Next Generation Microbiology Requirements

    Science.gov (United States)

    Ott, C. M.; Oubre, C. M.; Elliott, T. F.; Castro, V. A.; Pierson, D. L.

    2012-01-01

    As humans continue to explore deep into space, microorganisms will travel with them. The primary means to mitigate the risk of infectious disease are a combination of prudent spacecraft design and rigorous operational controls. The effectiveness of these methods are evaluated by microbiological monitoring of spacecraft, food, water, and the crew that is performed preflight, in-flight, and post-flight. Current NASA requirements associated with microbiological monitoring are based on culture-based methodology where microorganisms are grown on a semi-solid growth medium and enumerated. Subsequent identification of the organisms requires specialized labor and large equipment, which historically has been performed on Earth. Requirements that rely strictly on culture-based units limit the use of non-culture based monitoring technology. Specifically, the culture-based "measurement criteria" are Colony Forming Units (CFU, representing the growth of one microorganism at a single location on the agar medium) per a given volume, area, or sample size. As the CFU unit by definition is culture-based, these requirements limit alternative technologies for spaceflight applications. As spaceflight missions such as those to Mars extend further into space, culture-based technology will become difficult to implement due to the (a) limited shelf life of the culture media, (b) mass/volume necessary to carry these consumables, and (c) problems associated with the production of biohazardous material in the habitable volume of the spacecraft. In addition, an extensive amount of new knowledge has been obtained during the Space Shuttle, NASA-Mir, and International Space Station Programs, which gave direction for new or modified microbial control requirements for vehicle design and mission operations. The goal of this task is to develop and recommend a new set of requirements for vehicle design and mission operations, including microbiological monitoring, based upon "lessons learned" and new

  5. Essential Requirements of PPAP

    Directory of Open Access Journals (Sweden)

    A.P. Shrotri

    2014-06-01

    Full Text Available In today’s competitive environment industries are using various quality standards, such as ISO, TS, APQP etc. While applying these standards in any organizations there are certain procedures. Extensive technical documentation is the major requirement of every standard mentioned above. The Production Part Approval Process is one of the quality assurance procedures which is necessary in now days, especially in Automotive industries. The purpose of Production Part Approval Process (PPAP is as follows. 1 To provide the detailed information including design process, production process, inspection to the customer. 2 To assure the customer that the current manufacturing process is able to fulfill the requirement and special demands of the customer.

  6. Business Process Requirement Engineering

    Directory of Open Access Journals (Sweden)

    Atsa Etoundi Roger,

    2010-12-01

    Full Text Available Requirement engineering is as an increasingly important discipline for supporting business process and workflow modeling, as these are designed to satisfy diverse customer needs, and increase the productivity of enterprise. Moreover, most customers hesitate to adopt a given product or service if the added value is not conformed to their desires. Dealing with customers, with a wide range of perspective, within an enterprise, is very complex. These perspectives are grounded in differences in skills, responsibility, knowledge and expertise of stakeholders. This holds more in the domain of business processes and workflows where the satisfaction of the customers is the must if these enterprises wish to deal with the pressure of the network economy. Based on the requirement engineering, we present in this paper an integration of RE approach in the modeling of business process and workflows. (Abstract

  7. TANK FARM ENVIRONMENTAL REQUIREMENTS

    International Nuclear Information System (INIS)

    Through regulations, permitting or binding negotiations, Regulators establish requirements, limits, permit conditions and Notice of Construction (NOC) conditions with which the Office of River Protection (ORP) and the Tank Farm Contractor (TFC) must comply. Operating Specifications are technical limits which are set on a process to prevent injury to personnel, or damage to the facility or environment, The main purpose of this document is to provide specification limits and recovery actions for the TFC Environmental Surveillance Program at the Hanford Site. Specification limits are given for monitoring frequencies and permissible variation of readings from an established baseline or previous reading. The requirements in this document are driven by environmental considerations and data analysis issues, rather than facility design or personnel safety issues. This document is applicable to all single-shell tank (SST) and double-shell tank (DST) waste tanks, and the associated catch tanks and receiver tanks, and transfer systems. This Tank Farm Environmental Specifications Document (ESD) implements environmental-regulatory limits on the configuration and operation of the Hanford Tank Farms facility that have been established by Regulators. This ESD contains specific field operational limits and recovery actions for compliance with airborne effluent regulations and agreements, liquid effluents regulations and agreements, and environmental tank system requirements. The scope of this ESD is limited to conditions that have direct impact on Operations/Projects or that Operations Projects have direct impact upon. This document does not supercede or replace any Department of Energy (DOE) Orders, regulatory permits, notices of construction, or Regulatory agency agreements binding on the ORP or the TFC. Refer to the appropriate regulation, permit, or Notice of Construction for an inclusive listing of requirements

  8. [Constitutional requirements of rationing].

    Science.gov (United States)

    Kluth, Winfried

    2008-01-01

    Rationing is an emotive issue in the field of public health. This complicates the rational discourse, which is indispensable for analyzing the rationing conditions as set out by constitutional law and which requires manifold differentiation and consideration that shall briefly be outlined in the following short contribution. Of central significance is the distinction between indirect and direct rationing as well as the reference to the essential responsibility of legislators for rationing decisions. PMID:19004184

  9. Science in Requirements Engineering

    OpenAIRE

    Suhaimi Jaafar

    2014-01-01

    Based on a review of the articles about methodological principles, and some research classifications, in this work an overview of the nature and status of science in Requirements Engineering is done. The discussion takes a broad perspective of debates in other areas, including the methodologies in natural sciences, the social areas, information systems, and research design. It is proposed a new categorization for concepts validation and evaluation, and is suggested a framework criteria inspir...

  10. Utility requirements for HTGRs

    International Nuclear Information System (INIS)

    Eskom, the state utility of South Africa, is currently evaluating the technical and economic feasibility of the helium cooled Pebble Bed Modular Reactor with a closed cycle gas turbine power conversion system for future power generating additions to its electric system. This paper provides an overview of the Eskom system including the needs of the utility for future generation capacity and the key performance requirements necessary for incorporation of this gas cooled reactor plant. (author)

  11. OCRWM supercomputer requirements analysis

    International Nuclear Information System (INIS)

    The OCRWM program involves to a large extent the use of computer codes to conduct performance and safety analyses. A variety of computer codes are developed and used by OCRWM contractors. Some OCRWM contractors utilize supercomputer capacity already available at the laboratories (e.g., CRAY-XMP/48 or CRAY-XMP/24) and others utilize smaller computers (e.g., front-end machines, workstations, or PCs). The purpose of this requirements analysis is to identify the computational capacity needs of OCRWM and its contractors from 1989 to 1998 (assuming that all appropriate OCRWM codes are translated into supercomputer usage). Included in this report are: the geographic and organizational locations of OCRWM's computational capacity needs, as estimated from existing and projected in-house and contractor requirements; the generic and specific computer codes expected to be used by OCRWM; the expected machine requirements for the codes to be used, considering such parameters as computational needs and input/output complexity; and the expected supercomputer computational demand over the ten-year period of interest. 2 figs., 4 tabs

  12. LEGACY MANAGEMENT REQUIRES INFORMATION

    International Nuclear Information System (INIS)

    ''Legacy Management Requires Information'' describes the goal(s) of the US Department of Energy's Office of Legacy Management (LM) relative to maintaining critical records and the way those goals are being addressed at Hanford. The paper discusses the current practices for document control, as well as the use of modern databases for both storing and accessing the data to support cleanup decisions. In addition to the information goals of LM, the Hanford Federal Facility Agreement and Consent Order, known as the ''Tri-Party Agreement'' (TPA) is one of the main drivers in documentation and data management. The TPA, which specifies discrete milestones for cleaning up the Hanford Site, is a legally binding agreement among the US Department of Energy (DOE), the Washington State Department of Ecology (Ecology), and the US Environmental Protection Agency (EPA). The TPA requires that DOE provide the lead regulatory agency with the results of analytical laboratory and non-laboratory tests/readings to help guide them in making decisions. The Agreement also calls for each signatory to preserve--for at least ten years after the Agreement has ended--all of the records in its or its contractors, possession related to sampling, analysis, investigations, and monitoring conducted. The tools used at Hanford to meet TPA requirements are also the tools that can satisfy the needs of LM

  13. Morsleben waste acceptance requirements

    International Nuclear Information System (INIS)

    The Morsleben waste acceptance requirements take into account the valid stipulations in the permanent operational license of the Morsleben repository for radioactive waste (Eram) dated April 22, 1986, and in the documents underlying it. In line with the guaranteed continued validity until June 30, 2000 of this permanent operational license, also the classification of radioactive waste by waste types (A) and radiation protection groups (S) was retained. The revised requirements to be met by radioactive waste to be disposed of in Eram as issued by the German Federal Office for Radiation Protection (BfS) effective August 1996 constitute the safety framework which must be adhered to by this waste. They also take into account other stipulations by the BfS, especially voluntary restrictions and conditions imposed by the self-surveillance. Eram accepts the 'solid waste' and 'spent sealed radiation sources' categories. The waste generators must observe the requirements to be met by waste to be stored permanently. In the case of solid waste, these conditions include criteria to be met by waste forms, activity limitations for radionuclides and groups of radionuclides, and packaging criteria. (orig.)

  14. LEGACY MANAGEMENT REQUIRES INFORMATION

    Energy Technology Data Exchange (ETDEWEB)

    CONNELL, C.W.; HILDEBRAND, R.D.

    2006-12-14

    ''Legacy Management Requires Information'' describes the goal(s) of the US Department of Energy's Office of Legacy Management (LM) relative to maintaining critical records and the way those goals are being addressed at Hanford. The paper discusses the current practices for document control, as well as the use of modern databases for both storing and accessing the data to support cleanup decisions. In addition to the information goals of LM, the Hanford Federal Facility Agreement and Consent Order, known as the ''Tri-Party Agreement'' (TPA) is one of the main drivers in documentation and data management. The TPA, which specifies discrete milestones for cleaning up the Hanford Site, is a legally binding agreement among the US Department of Energy (DOE), the Washington State Department of Ecology (Ecology), and the US Environmental Protection Agency (EPA). The TPA requires that DOE provide the lead regulatory agency with the results of analytical laboratory and non-laboratory tests/readings to help guide them in making decisions. The Agreement also calls for each signatory to preserve--for at least ten years after the Agreement has ended--all of the records in its or its contractors, possession related to sampling, analysis, investigations, and monitoring conducted. The tools used at Hanford to meet TPA requirements are also the tools that can satisfy the needs of LM.

  15. BER Science Network Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Alapaty, Kiran; Allen, Ben; Bell, Greg; Benton, David; Brettin, Tom; Canon, Shane; Dart, Eli; Cotter, Steve; Crivelli, Silvia; Carlson, Rich; Dattoria, Vince; Desai, Narayan; Egan, Richard; Tierney, Brian; Goodwin, Ken; Gregurick, Susan; Hicks, Susan; Johnston, Bill; de Jong, Bert; Kleese van Dam, Kerstin; Livny, Miron; Markowitz, Victor; McGraw, Jim; McCord, Raymond; Oehmen, Chris; Regimbal, Kevin; Shipman, Galen; Strand, Gary; Flick, Jeff; Turnbull, Susan; Williams, Dean; Zurawski, Jason

    2010-11-01

    The Energy Sciences Network (ESnet) is the primary provider of network connectivity for the US Department of Energy Office of Science, the single largest supporter of basic research in the physical sciences in the United States. In support of the Office of Science programs, ESnet regularly updates and refreshes its understanding of the networking requirements of the instruments, facilities, scientists, and science programs that it serves. This focus has helped ESnet to be a highly successful enabler of scientific discovery for over 20 years. In April 2010 ESnet and the Office of Biological and Environmental Research, of the DOE Office of Science, organized a workshop to characterize the networking requirements of the science programs funded by BER. The requirements identified at the workshop are summarized and described in more detail in the case studies and the Findings section. A number of common themes emerged from the case studies and workshop discussions. One is that BER science, like many other disciplines, is becoming more and more distributed and collaborative in nature. Another common theme is that data set sizes are exploding. Climate Science in particular is on the verge of needing to manage exabytes of data, and Genomics is on the verge of a huge paradigm shift in the number of sites with sequencers and the amount of sequencer data being generated.

  16. Requirements for ITER diagnostics

    International Nuclear Information System (INIS)

    The development and design of plasma diagnostics for the International Thermonuclear Experimental Reactor (ITER) present a formidable challenge for experimental plasma physicists. The large plasma size, the high central density and temperature and the very high thermal wall loadings provide new challenges for present measurement techniques and lead to a search for new methods. But the physics and control requirements for the long burn phase of the discharge, combined with very limited access to the plasma, constrained by the requirement for radiation shielding of the coils and sharing of access ports with heating and current drive power, remote manipulation, fueling and turn blanket modules, make for very difficult design choices. An initial attempt at these choices has been made by an international team of diagnostic physicists, gathering together in a series of three workshops during the ITER Conceptual Design Activity. This paper is based on that report and provides a summary of its most important points. To provide a background against which to place the diagnostic requirements and design concepts, the ITER device, its most important plasma properties and the proposed experimental program will be described. The specifications for the measurement of the plasma parameters and the proposed diagnostics for these measurements will then be addressed, followed by some examples of the design concepts that have been proposed. As a result of these design studies, it was clear that there were many uncertainties associated with these concepts, particularly because of the nuclear radiation environment, so that a Research and Development Program for diagnostic hardware was established. It will also be briefly summarized

  17. NIRVANA network requirements

    Energy Technology Data Exchange (ETDEWEB)

    Wood, B.J.

    1990-08-01

    NIRVANA is an effort to standardize electrical computer-aided design workstations at Sandia National Laboratories in Albuquerque, New Mexico. The early effect of this project will be the introduction of at least 60 new engineering workstations at Sandia National Laboratories. Albuquerque, and at Allied Signal, Kansas City Division. These workstations are expected to begin arriving in September 1990. This paper proposes a design and outlines the requirements for a network to support the NIRVANA project. The author proposes a near-term network design, describes the security profile and caveats of this design, and proposes a long-term networking strategy for NIRVANA. 6 refs., 7 figs.

  18. BES Science Network Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Biocca, Alan; Carlson, Rich; Chen, Jackie; Cotter, Steve; Tierney, Brian; Dattoria, Vince; Davenport, Jim; Gaenko, Alexander; Kent, Paul; Lamm, Monica; Miller, Stephen; Mundy, Chris; Ndousse, Thomas; Pederson, Mark; Perazzo, Amedeo; Popescu, Razvan; Rouson, Damian; Sekine, Yukiko; Sumpter, Bobby; Dart, Eli; Wang, Cai-Zhuang -Z; Whitelam, Steve; Zurawski, Jason

    2011-02-01

    The Energy Sciences Network (ESnet) is the primary provider of network connectivityfor the US Department of Energy Office of Science (SC), the single largest supporter of basic research in the physical sciences in the United States. In support of the Office ofScience programs, ESnet regularly updates and refreshes its understanding of the networking requirements of the instruments, facilities, scientists, and science programs that it serves. This focus has helped ESnet to be a highly successful enabler of scientific discovery for over 20 years.

  19. BES Science Network Requirements

    International Nuclear Information System (INIS)

    The Energy Sciences Network (ESnet) is the primary provider of network connectivity for the US Department of Energy Office of Science (SC), the single largest supporter of basic research in the physical sciences in the United States. In support of the Office of Science programs, ESnet regularly updates and refreshes its understanding of the networking requirements of the instruments, facilities, scientists, and science programs that it serves. This focus has helped ESnet to be a highly successful enabler of scientific discovery for over 20 years.

  20. Importance of Requirement Management : A Requirement Engineering Concern

    OpenAIRE

    Dhirendra Pandey; Vandana Pandey

    2012-01-01

    Requirement engineering is first phase of software development processes and it is most important phase for every software development model. In requirement engineering phase we can gather the requirements from user and use this requirement to software development and produce software product that satisfy the user needs. In this research paper we describe the fundamental description of requirement engineering and present the basics dimensions of requirement engineering. Also, in this research...

  1. Importance of Requirement Management : A Requirement Engineering Concern

    Directory of Open Access Journals (Sweden)

    Dhirendra Pandey

    2012-06-01

    Full Text Available Requirement engineering is first phase of software development processes and it is most important phase for every software development model. In requirement engineering phase we can gather the requirements from user and use this requirement to software development and produce software product that satisfy the user needs. In this research paper we describe the fundamental description of requirement engineering and present the basics dimensions of requirement engineering. Also, in this research paper we also give the basic idea of software requirement specification and present the concept of why requirement management is important for software development.

  2. Repository seals requirements study

    International Nuclear Information System (INIS)

    The Yucca Mountain Site Characterization Project, managed by the Civilian Radioactive Waste Management System (CRWMS) Management and Operating Contractor (M and O) is conducting investigations to support the Viability Assessment and the License Application for a high-level nuclear waste repository at Yucca Mountain, Nevada. The sealing subsystem is part of the Yucca Mountain Waste Isolation System. The Yucca Mountain Site Characterization Project is currently evaluating the role of the sealing subsystem (shaft, ramp and exploratory borehole seals) in achieving the overall performance objectives for the Waste Isolation System. This report documents the results of those evaluations. This report presents the results of a repository sealing requirements study. Sealing is defined as the permanent closure of the shafts, ramps, and exploratory boreholes. Sealing includes those components that would reduce potential inflows above the repository, or that would divert flow near the repository horizon to allow vertical infiltration to below the repository. Sealing of such features as emplacement drifts was not done in this study because the current capability to calculate fracture flow into the drifts is not sufficiently mature. The objective of the study is to provide water or air flow performance based requirements for shafts, ramps, and exploratory boreholes located near the repository. Recommendations, as appropriate, are provided for developing plans, seals component testing, and other studies relating to sealing

  3. Section 4: Requirements Intertwining

    Science.gov (United States)

    Loucopoulos, Pericles

    Business analysts are being asked to develop increasingly complex and varied business systems that need to cater to the changing and dynamic market conditions of the new economy. This is particularly acute in today’s turbulent business environment where powerful forces such as deregulation, globalisation, mergers, advances in information and telecommunications technologies, and increasing education of people provide opportunities for organising work in ways that have never before been possible. Enterprises attempt to create wealth either by getting better at improving their products and services or by harnessing creativity and human-centred management to create innovative solutions. In these business settings, requirements become critical in bridging system solutions to organisational and societal problems. They intertwine organisational, social, cognitive, and implementation considerations and they can provide unique insights to change in systems and their business context. Such design situations often involve multiple stakeholders from different participating organisations, subcontractors, divisions, etc., who may have a diversity of expertise, come from different organisational cultures and often have competing goals. The success or failure of many projects depends, to a large extent, on understanding the contextual setting of requirements and their interaction amongst a diverse population of stakeholders.

  4. Repository seals requirements study

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-11-03

    The Yucca Mountain Site Characterization Project, managed by the Civilian Radioactive Waste Management System (CRWMS) Management and Operating Contractor (M and O) is conducting investigations to support the Viability Assessment and the License Application for a high-level nuclear waste repository at Yucca Mountain, Nevada. The sealing subsystem is part of the Yucca Mountain Waste Isolation System. The Yucca Mountain Site Characterization Project is currently evaluating the role of the sealing subsystem (shaft, ramp and exploratory borehole seals) in achieving the overall performance objectives for the Waste Isolation System. This report documents the results of those evaluations. This report presents the results of a repository sealing requirements study. Sealing is defined as the permanent closure of the shafts, ramps, and exploratory boreholes. Sealing includes those components that would reduce potential inflows above the repository, or that would divert flow near the repository horizon to allow vertical infiltration to below the repository. Sealing of such features as emplacement drifts was not done in this study because the current capability to calculate fracture flow into the drifts is not sufficiently mature. The objective of the study is to provide water or air flow performance based requirements for shafts, ramps, and exploratory boreholes located near the repository. Recommendations, as appropriate, are provided for developing plans, seals component testing, and other studies relating to sealing.

  5. Repository seals requirement study

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-11-03

    The Yucca Mountain Site Characterization Project, managed by the Civilian Radioactive Waste Management System (CRWMS) Management and Operating Contractor (M and O) is conducting investigations to support the Viability Assessment and the License Application for a high-level nuclear waste repository at Yucca Mountain, Nevada. The sealing subsystem is part of the Yucca Mountain Waste Isolation System. The Yucca Mountain Site Characterization Project is currently evaluating the role of the sealing subsystem (shaft, ramp and exploratory borehole seals) in achieving the overall performance objectives for the Waste Isolation System. This report documents the results of those evaluations. The objective of the study is to provide water or air flow performance based requirements for shafts, ramps, and exploratory boreholes located near the repository. Recommendations, as appropriate, are provided for developing plans, seals component testing, and other studies relating to sealing.

  6. Equipment Operational Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Greenwalt, B; Henderer, B; Hibbard, W; Mercer, M

    2009-06-11

    The Iraq Department of Border Enforcement is rich in personnel, but poor in equipment. An effective border control system must include detection, discrimination, decision, tracking and interdiction, capture, identification, and disposition. An equipment solution that addresses only a part of this will not succeed, likewise equipment by itself is not the answer without considering the personnel and how they would employ the equipment. The solution should take advantage of the existing in-place system and address all of the critical functions. The solutions are envisioned as being implemented in a phased manner, where Solution 1 is followed by Solution 2 and eventually by Solution 3. This allows adequate time for training and gaining operational experience for successively more complex equipment. Detailed descriptions of the components follow the solution descriptions. Solution 1 - This solution is based on changes to CONOPs, and does not have a technology component. It consists of observers at the forts and annexes, forward patrols along the swamp edge, in depth patrols approximately 10 kilometers inland from the swamp, and checkpoints on major roads. Solution 2 - This solution adds a ground sensor array to the Solution 1 system. Solution 3 - This solution is based around installing a radar/video camera system on each fort. It employs the CONOPS from Solution 1, but uses minimal ground sensors deployed only in areas with poor radar/video camera coverage (such as canals and streams shielded by vegetation), or by roads covered by radar but outside the range of the radar associated cameras. This document provides broad operational requirements for major equipment components along with sufficient operational details to allow the technical community to identify potential hardware candidates. Continuing analysis will develop quantities required and more detailed tactics, techniques, and procedures.

  7. NASA gateway requirements analysis

    Science.gov (United States)

    Duncan, Denise R.; Doby, John S.; Shockley, Cynthia W.

    1991-01-01

    NASA devotes approximately 40 percent of its budget to R&D. Twelve NASA Research Centers and their contractors conduct this R&D, which ranges across many disciplines and is fueled by information about previous endeavors. Locating the right information is crucial. While NASA researchers use peer contacts as their primary source of scientific and technical information (STI), on-line bibliographic data bases - both Government-owned and commercial - are also frequently consulted. Once identified, the STI must be delivered in a usable format. This report assesses the appropriateness of developing an intelligent gateway interface for the NASA R&D community as a means of obtaining improved access to relevant STI resources outside of NASA's Remote Console (RECON) on-line bibliographic database. A study was conducted to determine (1) the information requirements of the R&D community, (2) the information sources to meet those requirements, and (3) ways of facilitating access to those information sources. Findings indicate that NASA researchers need more comprehensive STI coverage of disciplines not now represented in the RECON database. This augmented subject coverage should preferably be provided by both domestic and foreign STI sources. It was also found that NASA researchers frequently request rapid delivery of STI, in its original format. Finally, it was found that researchers need a better system for alerting them to recent developments in their areas of interest. A gateway that provides access to domestic and international information sources can also solve several shortcomings in the present STI delivery system. NASA should further test the practicality of a gateway as a mechanism for improved STI access.

  8. Producing a Global Requirement Model from Multiple Requirement Specifications

    OpenAIRE

    Brottier, Erwan; Baudry, Benoit; Le Traon,Yves; Touzet, David; Nicolas, Bertrand

    2007-01-01

    Requirements documentation is a collection of partial specifications produced by different stakeholders. Obtaining a global specification is a fundamental step of a requirement analysis process. Merging requirement specifications is indeed a way to reveal inconsistencies between them. We propose in this paper a model-driven mechanism for that purpose. It takes as inputs a set of texts or models which conform to input requirement languages and produces a global requirements model. This mechani...

  9. ASCR Science Network Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Dart, Eli; Tierney, Brian

    2009-08-24

    The Energy Sciences Network (ESnet) is the primary provider of network connectivity for the US Department of Energy Office of Science, the single largest supporter of basic research in the physical sciences in the United States. In support of the Office of Science programs, ESnet regularly updates and refreshes its understanding of the networking requirements of the instruments, facilities, scientists, and science programs that it serves. This focus has helped ESnet to be a highly successful enabler of scientific discovery for over 20 years. In April 2009 ESnet and the Office of Advanced Scientific Computing Research (ASCR), of the DOE Office of Science, organized a workshop to characterize the networking requirements of the programs funded by ASCR. The ASCR facilities anticipate significant increases in wide area bandwidth utilization, driven largely by the increased capabilities of computational resources and the wide scope of collaboration that is a hallmark of modern science. Many scientists move data sets between facilities for analysis, and in some cases (for example the Earth System Grid and the Open Science Grid), data distribution is an essential component of the use of ASCR facilities by scientists. Due to the projected growth in wide area data transfer needs, the ASCR supercomputer centers all expect to deploy and use 100 Gigabit per second networking technology for wide area connectivity as soon as that deployment is financially feasible. In addition to the network connectivity that ESnet provides, the ESnet Collaboration Services (ECS) are critical to several science communities. ESnet identity and trust services, such as the DOEGrids certificate authority, are widely used both by the supercomputer centers and by collaborations such as Open Science Grid (OSG) and the Earth System Grid (ESG). Ease of use is a key determinant of the scientific utility of network-based services. Therefore, a key enabling aspect for scientists beneficial use of high

  10. Vegetarian athletes: Special requirements

    Directory of Open Access Journals (Sweden)

    Dilek Ongan

    2012-01-01

    Full Text Available Vegetarian diets have been mentioned on having long and short term beneficial effects while they are important parts of the Western countries. Vegetarians are not homogeneous groups and subjects are motivated to be on a vegetarian diet because of culturel and regional reasons, ethical concerns including animal rights, health parameters and environmental situations. And these reasons differ from vegetarian and omnivour athletes. Athletes, especially endurance ones (sprinters, cyclists, triathlon athletes, …, eat vegetarian diets in order to meet increasing requirements of carbohydrate and manage their weight status. A healthily well planned vegetarian diet positively affect some parameters related with performance of the athlete. However in a diet based on vegetable, herbs and high fiber, inadequate energy intake should be avoided. Although many vegetarian athletes are warned about consuming high amounts of protein, athletes take less protein than omnivour ones. Therefore, vegetarians should increase dietary protein quality by mixing different foods such as legumes and cereals. Vegetarian athletes who avoid eating animal based foods are at risk of having inadequate energy, fat (essential fatty acids, vitamins B12, B2, D and calcium, iron and zinc. In this review, contribution of vegetarian diets on purpose of healthy eating and optimal athletic performance and nutritional strategies for vegetarian athletes were discussed.

  11. Writing Quality Requirements (SRS: An Approach To Manage Requirements Volatility

    Directory of Open Access Journals (Sweden)

    Ranjana Rajnish

    2010-06-01

    Full Text Available Quality requirements, that form a major sub-category of requirements, define a broad set system-wide attributes such as security, performance, usability and scalability. Unfortunately, many organizations pay less attention to quality requirements & assume that the necessary qualities are implicitly understood & will naturally emerge as the product is developed.In this paper, we would try to address important questions related to role of quality requirements in the software development lifecycle, and techniques for managing them effectively. Also, we would find out as to what happens when requirements are not managed? and suggest some practices to write quality requirements. The purpose is to make the community specifying the requirements understand requirements defects that have been made in the past. Hopefully, it also helps to avoid similar mistakes in the future.

  12. Requirement Assurance: A Verification Process

    Science.gov (United States)

    Alexander, Michael G.

    2011-01-01

    Requirement Assurance is an act of requirement verification which assures the stakeholder or customer that a product requirement has produced its "as realized product" and has been verified with conclusive evidence. Product requirement verification answers the question, "did the product meet the stated specification, performance, or design documentation?". In order to ensure the system was built correctly, the practicing system engineer must verify each product requirement using verification methods of inspection, analysis, demonstration, or test. The products of these methods are the "verification artifacts" or "closure artifacts" which are the objective evidence needed to prove the product requirements meet the verification success criteria. Institutional direction is given to the System Engineer in NPR 7123.1A NASA Systems Engineering Processes and Requirements with regards to the requirement verification process. In response, the verification methodology offered in this report meets both the institutional process and requirement verification best practices.

  13. An Investigation of Online Homework: Required or Not Required?

    Science.gov (United States)

    Wooten, Tommy; Dillard-Eggers, Jane

    2013-01-01

    In our research we investigate the use of online homework in principles of accounting classes where some classes required online homework while other classes did not. Users of online homework, compared to nonusers, had a higher grade point average and earned a higher grade in class. On average, both required and not-required users rated the online…

  14. Evaluation of safety of haemophilus influenza type b(Hib) conjugate vaccine in postmarketing based on the immunization information management system%基于预防接种信息管理系统的b型流感嗜血杆菌结合疫苗上市后安全性评价

    Institute of Scientific and Technical Information of China (English)

    汪志国; 马福宝; 张晋琳; 于静; 康国栋; 高君

    2015-01-01

    合疫苗具有良好的安全性,但需关注预防接种后过敏性休克、喉头水肿等急性过敏性反应的发生.%Objective To analyze the occurrence feature of adverse events following immunization (AEFI)of Hib conjugate vaccine(HibCV) and to evaluate the safety of HibCV in postmarketing.Methods 2008-2013 HibCV AEFI data were collected through national AEFI information management system,which were downloaded in March 18,2014.The demographic information and inoculation quantity of HibCV were from Immunization information management system in Jiangsu province.The incidence rate and 95% CI value of AEFI,common vaccine reaction and rare vaccine reaction following immunization of HibCV were calculated.The differences in the incidence rate of common vaccine reaction and rare vaccine reaction among sex,months of age,and number of injections were compared by means of x2 tests.Results A total of 6.16 million doses of vaccine were administered in Jiangsu province during 2008-2013,and 4 718 vaccinees reported having adverse event,for a rate of 76.60/100 000(95% CI:74.42/100 000-78.79/100 000).The incidence rate of common vaccine reaction and rare vaccine reaction was 71.10/100 000(95%CI:68.99/100 000-73.20/100 000)and 5.16/100 000(95% CI:4.60/100 000-5.73/100 000),respectively.The main symptoms of common vaccine reactions were fever,swelling,indurations and gastrointestinal reactions.The incidence rates of them were 40.54/100 000,35.09/100 000,12.94/100 000 and 0.36/100 000 in turn.The main symptoms of rare vaccine reactions were anaphylactic rashes and angioedema,the incidence rates of which were 4.77/100 000 and 0.15/100 000 respectively.91.39% (4 002/4 379) of common vaccine reactions and 88.36% (281/318) of rare vaccine reactions happened within 1 d after vaccination.Anaphylactic shock (3 cases) and laryngeal edema (1 case) all happened within 1 d after vaccination.The incidence rate of common vaccine reactions among boys (79.72/100 000,2 641/3 313

  15. Software Security Requirements Gathering Instrument

    OpenAIRE

    Smriti Jain; Maya Ingle

    2011-01-01

    Security breaches are largely caused by the vulnerable software. Since individuals and organizations mostly depend on softwares, it is important to produce in secured manner. The first step towards producing secured software is through gathering security requirements. This paper describes Software Security Requirements Gathering Instrument (SSRGI) that helps gather security requirements from the various stakeholders. This will guide the developers to gather security requirements along with th...

  16. Physician Requirements-1990. For Cardiology.

    Science.gov (United States)

    Tracy, Octavious; Birchette-Pierce, Cheryl

    Professional requirements for physicians specializing in cardiology were estimated to assist policymakers in developing guidelines for graduate medical education. The determination of physician requirements was based on an adjusted needs rather than a demand or utilization model. For each illness, manpower requirements were modified by the…

  17. Requirements Engineering for Social Software

    OpenAIRE

    Glukhova, Anna

    2009-01-01

    Social software bears some special characteristics for requirements engineering (RE) like user-centeredness, self-organization and voluntarism. No concrete formalization of the RE process for social software has been established so far. In this position paper, important aspects of social contexts will be considered in order to define requirements, referring to the previously identified four key requirements principles.

  18. Cross-neutralizing antibodies elicited by the Cervarix® human papillomavirus vaccine display a range of Alpha-9 inter-type specificities ☆

    OpenAIRE

    Bissett, Sara L; Draper, Eve; Myers, Richard E.; Godi, Anna; Beddows, Simon

    2014-01-01

    The highly efficacious human papillomavirus (HPV) vaccines contain virus-like particles (VLP) representing genotypes HPV16 and HPV18, which together account for approximately 70% of cervical cancer cases. Vaccine-type protection is thought to be mediated by high titer, type-specific neutralizing antibodies. The vaccines also confer a degree of cross-protection against some genetically-related types from the Alpha-9 (HPV16-like: HPV31, HPV33, HPV35, HPV52, HPV58) and Alpha-7 (HPV18-like: HPV39...

  19. Tool-based requirement traceability between requirement and design artifacts

    CERN Document Server

    Turban, Bernhard

    2013-01-01

    Processes for developing safety-critical systems impose special demands on ensuring requirements traceability. Achieving valuable traceability information, however, is especially difficult concerning the transition from requirements to design. Bernhard Turban analyzes systems and software engineering theories cross-cutting the issue (embedded systems development, systems engineering, software engineering, requirements engineering and management, design theory and processes for safety-critical systems). As a solution, the author proposes a new tool approach to support designers in their thinkin

  20. National Ignition Facility site requirements

    International Nuclear Information System (INIS)

    The Site Requirements (SR) provide bases for identification of candidate host sites for the National Ignition Facility (NIF) and for the generation of data regarding potential actual locations for the facilities. The SR supplements the NIF Functional Requirements (FR) with information needed for preparation of responses to queries for input to HQ DOE site evaluation. The queries are to include both documents and explicit requirements for the potential host site responses. The Sr includes information extracted from the NIF FR (for convenience), data based on design approaches, and needs for physical and organization infrastructure for a fully operational NIF. The FR and SR describe requirements that may require new construction or may be met by use or modification of existing facilities. The SR do not establish requirements for NIF design or construction project planning. The SR document does not constitute an element of the NIF technical baseline

  1. Information requirements for enterprise systems

    OpenAIRE

    Sommerville, I.; Lock, R.; Storer, T.

    2012-01-01

    In this paper, we discuss an approach to system requirements engineering, which is based on using models of the responsibilities assigned to agents in a multi-agency system of systems. The responsibility models serve as a basis for identifying the stakeholders that should be considered in establishing the requirements and provide a basis for a structured approach, described here, for information requirements elicitation. We illustrate this approach using a case study drawn from civil emergenc...

  2. Verifying ontology requirements with SWIP

    OpenAIRE

    Suárez-Figueroa, Mari Carmen; Pradel, Camille; Hernandez, Nathalie

    2012-01-01

    Verifying whether an ontology meets the set of established requirements is a crucial activity in ontology engineering. In this sense, methods and tools are needed (a) to transform (semi-)automatically functional ontology requirements into SPARQL queries, which can serve as unit tests to verify the ontology, and (b) to check whether the ontology fulfils the requirements. Thus, our purpose in this poster paper is to apply the SWIP approach to verify whether an ontology satisfies the set of esta...

  3. Federal Environmental Requirements for Construction

    Data.gov (United States)

    Department of Veterans Affairs — This guide provides information on federal environmental requirements for construction projects. It is written primarily for owners of construction projects and for...

  4. Mineral requirements of dairy sheep

    International Nuclear Information System (INIS)

    The mineral requirements of dairy sheep under semi-intensive and intensive management systems are reviewed. Basically, mineral requirements obtained with mutton breeds are supplemented with specific information obtained with dairy sheep. The daily requirements of sheep in major elements have been estimated using the factorial method, first to calculate the net requirements during maintenance, growth, reproduction and lactation, and second to assess the efficiency of absorption for converting net requirements into dietary allowance. The requirements in trace elements were estimated from the results of feeding trials. The choice of values for endogenous losses and particularly the precision with which efficiency of absorption can be predicted are the main sources of error in estimates of dietary allowances, especially when efficiency of absorption is low. The net requirements in major elements are given for maintenance, pregnancy and lactation, together with the recommended coefficients of absorption. Dietary requirements in trace elements are expressed as milligram per kilogram dry matter. The requirements in all nutrients and particularly in Ca and P increase during late pregnancy, especially during lactation. The requirements during lactation mainly reflect milk composition, the level of milk yield and lactation length, but also the feed intake level. The factors related to the confinement, feeding and management of dairy breeds, which differ from those of mutton breeds, may affect their mineral requirements. Changes in husbandry practices resulting in increased production may increase the stress on the animal and therefore alter its metabolic equilibrium. Direct supplementation of the diet of dairy sheep is the cheapest and most convenient method of mineral supplementation. The cost is outweighed by the enhanced performance of sheep. Determination of the mineral composition of feedstuffs available for feeding dairy sheep indicates the type and level of mineral

  5. Humidity requirements in WSCF Laboratories

    International Nuclear Information System (INIS)

    The purpose of this paper is to develop and document a position on Relative Humidity (RH) requirements in the WSCF Laboratories. A current survey of equipment vendors for Organic, Inorganic and Radiochemical laboratories indicate that 25% - 80% relative humidity may meet the environmental requirements for safe operation and protection of all the laboratory equipment

  6. Utility requirements for fusion power

    International Nuclear Information System (INIS)

    A four-man-month study, jointly funded by EPRI and McDonnell Douglas Astronautics Company-EAST, was undertaken to identify the utility requirements of fusion power and define a role for the utilities in the fusion development process during the 1980's. This report, preliminary in nature, serves mainly as a planning document for future requirements analyses. A requirements organization was defined to consist of three major chronological phases: research and development, plant installation, and plant operation. Thirty-seven requirements were identified, covering all categories. In addition, training, environment, safety, licensing, and utility model were identified as five matrix-type requirements. As the requirement definition process continued during the study period, comments received from utility representatives revealed a consistency of key issues in the fusion development process. These issues form the basis for the eventual establishment of definitive roles for the utilities during the 1980's. The issues are not meant to reflect a negative view of fusion, but are items which must be solved before fusion can be introduced commercially as an electrical power source. As a result of this requirements study, preliminary candidate roles for the utilities in the fusion development process during the 1980's were identified as public education, commercialization studies, industry investment analyses, training plan implementation, alternate reactor concept development, ERDA concept design review, and requirements refinement

  7. Nuclear energy and investment requirements

    International Nuclear Information System (INIS)

    The author assesses the investment requirements of the French nuclear programme within the framework of the national economy. He then evokes the means of financing these requirements as well as drawing attention to certain constraints which must be taken into account

  8. Crowd-Centric Requirements Engineering

    NARCIS (Netherlands)

    Snijders, Remco; Dalpiaz, Fabiano; Hosseini, Mahmood; Shahri, Alimohammad; Ali, Raian

    2014-01-01

    Requirements engineering is a preliminary and crucial phase for the correctness and quality of software systems. Despite the agreement on the positive correlation between user involvement in requirements engineering and software success, current development methods employ a too narrow concept of tha

  9. Subsurface Contamination Focus Area technical requirements. Volume 1: Requirements summary

    Energy Technology Data Exchange (ETDEWEB)

    Nickelson, D.; Nonte, J.; Richardson, J.

    1996-10-01

    This document summarizes functions and requirements for remediation of source term and plume sites identified by the Subsurface Contamination Focus Area. Included are detailed requirements and supporting information for source term and plume containment, stabilization, retrieval, and selective retrieval remedial activities. This information will be useful both to the decision-makers within the Subsurface Contamination Focus Area (SCFA) and to the technology providers who are developing and demonstrating technologies and systems. Requirements are often expressed as graphs or charts, which reflect the site-specific nature of the functions that must be performed. Many of the tradeoff studies associated with cost savings are identified in the text.

  10. The NLC Software Requirements Methodology

    CERN Document Server

    White, G R

    2001-01-01

    We describe the software requirements and development methodology developed for the NLC control system. Given the longevity of that project, and the likely geographical distribution of the collaborating engineers, the planned requirements management process is somewhat more formal than the norm in high energy physics projects. The short term goals of the requirements process are to accurately estimate costs, to decompose the problem, and to determine likely technologies. The long term goal is to enable a smooth transition from high level functional requirements to specific subsystem and component requirements for individual programmers, and to support distributed development. The methodology covers both ends of that life cycle. It covers both the analytical and documentary tools for software engineering, and project management support.

  11. Managing System of Systems Requirements with a Requirements Screening Group

    Energy Technology Data Exchange (ETDEWEB)

    Ronald R. Barden

    2012-07-01

    Figuring out an effective and efficient way to manage not only your Requirement’s Baseline, but also the development of all your individual requirements during a Program’s/Project’s Conceptual and Development Life Cycle Stages can be both daunting and difficult. This is especially so when you are dealing with a complex and large System of Systems (SoS) Program with potentially thousands and thousands of Top Level Requirements as well as an equal number of lower level System, Subsystem and Configuration Item requirements that need to be managed. This task is made even more overwhelming when you have to add in integration with multiple requirements’ development teams (e.g., Integrated Product Development Teams (IPTs)) and/or numerous System/Subsystem Design Teams. One solution for tackling this difficult activity on a recent large System of Systems Program was to develop and make use of a Requirements Screening Group (RSG). This group is essentially a Team made up of co-chairs from the various Stakeholders with an interest in the Program of record that are enabled and accountable for Requirements Development on the Program/Project. The RSG co-chairs, often with the help of individual support team, work together as a Program Board to monitor, make decisions on, and provide guidance on all Requirements Development activities during the Conceptual and Development Life Cycle Stages of a Program/Project. In addition, the RSG can establish and maintain the Requirements Baseline, monitor and enforce requirements traceability across the entire Program, and work with other elements of the Program/Project to ensure integration and coordination.

  12. Power requirements for PHERB powertrain

    Science.gov (United States)

    Norbakyah, J. S.; Atiq, W. H.; Salisa, A. R.

    2015-12-01

    Boats are considered as favourite maritime transportation designed for recreation activities, fishing and surveillance purposes. However, in tropical developed countries, boats are employed for different applications such as passenger and goods transportation. In this paper, the power requirements for a proposed plug-in hybrid electric recreational boat (PHERB) powertrain is determined using a steady state velocity and the Kuala Terengganu river driving cycle according to the boat parameters, specifications and performance requirements. The boat power requirements can be used to size the main components for PHERB powertrain. The results obtained from this analysis are within reasonable range and satisfactory.

  13. Model-based requirements engineering

    CERN Document Server

    Holt, Jon

    2012-01-01

    This book provides a hands-on introduction to model-based requirementsengineering and management by describing a set of views that form the basisfor the approach. These views take into account each individual requirement interms of its description, but then also provide each requirement with meaning byputting it into the correct 'context'. A requirement that has been put into a contextis known as a 'use case' and may be based upon either stakeholders or levelsof hierarchy in a system. Each use case must then be analysed and validated bydefining a combination of scenarios and formal mathematica

  14. Autonomous Real Time Requirements Tracing

    Science.gov (United States)

    Plattsmier, George; Stetson, Howard

    2014-01-01

    One of the more challenging aspects of software development is the ability to verify and validate the functional software requirements dictated by the Software Requirements Specification (SRS) and the Software Detail Design (SDD). Insuring the software has achieved the intended requirements is the responsibility of the Software Quality team and the Software Test team. The utilization of Timeliner-TLX(sup TM) Auto- Procedures for relocating ground operations positions to ISS automated on-board operations has begun the transition that would be required for manned deep space missions with minimal crew requirements. This transition also moves the auto-procedures from the procedure realm into the flight software arena and as such the operational requirements and testing will be more structured and rigorous. The autoprocedures would be required to meet NASA software standards as specified in the Software Safety Standard (NASASTD- 8719), the Software Engineering Requirements (NPR 7150), the Software Assurance Standard (NASA-STD-8739) and also the Human Rating Requirements (NPR-8705). The Autonomous Fluid Transfer System (AFTS) test-bed utilizes the Timeliner-TLX(sup TM) Language for development of autonomous command and control software. The Timeliner-TLX(sup TM) system has the unique feature of providing the current line of the statement in execution during real-time execution of the software. The feature of execution line number internal reporting unlocks the capability of monitoring the execution autonomously by use of a companion Timeliner-TLX(sup TM) sequence as the line number reporting is embedded inside the Timeliner-TLX(sup TM) execution engine. This negates I/O processing of this type data as the line number status of executing sequences is built-in as a function reference. This paper will outline the design and capabilities of the AFTS Autonomous Requirements Tracker, which traces and logs SRS requirements as they are being met during real-time execution of the

  15. PFP requirements development planning guide

    International Nuclear Information System (INIS)

    The PFP Requirements Development Planning Guide presents the strategy and process used for the identification, allocation, and maintenance of requirements within the Plutonium Finishing Plant (PFP) integrated project baseline. Future revisions to this document will be included as attachments (e.g., results of the PFP Requirements Analysis attributable to this approach). This document is intended be a Project-owned management tool. As such, this document will periodically require revisions resulting from improvements of the information, processes, and techniques as now described. Future updates may be made to this document by PFP management and final approval of the content will be accomplished in a Baseline Change Request as it impacts the Multi-Year Work Plan, or baseline information managed in the Hanford Site Systems Engineering Baseline

  16. Deaf mobile application accessibility requirements

    Science.gov (United States)

    Nathan, Shelena Soosay; Hussain, Azham; Hashim, Nor Laily

    2016-08-01

    Requirement for deaf mobile applications need to be analysed to ensure the disabilities need are instilled into the mobile applications developed for them. Universal design is understandable to comply every user needs, however specific disability is argued by the authors to have different need and requirements. These differences are among the reasons for these applications being developed to target for a specific group of people, however they are less usable and later abandoned. This study focuses on deriving requirements that are needed by the deaf in their mobile applications that are meant specifically for them. Studies on previous literature was conducted it can be concluded that graphic, text, multimedia and sign language interpreter are among mostly required features to be included in their mobile application to ensure the applications are usable for this community.

  17. Capital Requirements and Banks' Leniency

    DEFF Research Database (Denmark)

    Dietrich, J. Kimball; Wihlborg, Clas

    2003-01-01

    We investigate the effect of changes in capital regulation on the strictness(leniency) of loan terms using a simple model of bank capital requirements andasset quality examinations. Banks offer different levels of `leniency' in the senseof willingness to offer automatic extensions of loans in the...... presence of temporarypayment difficulties of borrowers. Banks offering lenient (less strict) loan termsmust have higher initial levels of capital and charge higher loan rates. Whencapital requirements are increased, both strict and lenient banks hold higher levelsof initial capital and they raise loan...... rates. As capital requirements increase thedifference between initial capital levels and between interest rates of strict andlenient banks decrease. Thus, higher capital requirements in recessions tend toreduce the interest rate premium paid for leniency. If a recession is interpreted asan increase in...

  18. Monitored Geologic Repository Requirements Document

    International Nuclear Information System (INIS)

    The objective of this document is to define the performance and system requirements for the development of the Monitored Geologic Repository (MGR), including the Waste Handling System, Waste Isolation System, and the Operational Support System consistent with the Civilian Radioactive Waste Management System Requirements Document (CRD). These requirements apply to design, construction, operation, and decommissioning. The document also presents an overall description of the MGR, its functions and its systems as described in Section 2.3. In addition, the MGR interfaces are identified. Development of the MGR must be consistent with the requirements of the this document. While the MGR may evolve and change through the design process, changes must occur in a controlled manner. This document and, as necessary, the CRD, will be revised to capture the changes. Also, changes in the CRD will be captured in revisions to this document as necessary

  19. Physics and detector simulation requirements

    International Nuclear Information System (INIS)

    This document describes the computing environment needed to meet the requirements for high energy physics Monte Carlo Calculations for the simulation of Superconducting Super Collider Laboratory physics and detectors

  20. ROS signalling - specificity is required

    DEFF Research Database (Denmark)

    Møller, Ian M; Sweetlove, Lee J

    2010-01-01

    the required specificity to selectively regulate nuclear genes required for dealing with localized stress, e.g. in chloroplasts or mitochondria. Here we argue that peptides deriving from proteolytic breakdown of oxidatively damaged proteins have the requisite specificity to act as secondary ROS...... messengers and regulate source-specific genes and in this way contribute to retrograde ROS signalling during oxidative stress. Likewise, unmodified peptides deriving from the breakdown of redundant proteins could help coordinate organellar and nuclear gene expression...

  1. Quality System Requirements QS-9000

    CERN Document Server

    The Automotive Industry Action Group. Detroit

    QS-9000 is the shorthand name for "Quality System Requirements QS-9000." It is the common supplier quality standard for DaimlerChrysler Corporation, Ford Motor Company, and General Motors Corporation. QS-9000 is based on the 1994 edition of ISO 9001, requirements that are particular to the automotive industry. These additions are considered automotive "interpretations" by the ISO community of accreditation bodies and registrars.

  2. Requirements Engineering Reference Model (REM)

    OpenAIRE

    Eva Geisberger; Manfred Broy Technische Universitaet Muenchen Brian Berenbach; Juergen Kazmeier; Daniel Paulish; Arnold Rudorfer Siemens Corporate Research Princeton

    2016-01-01

    Der folgende technische Bericht beschreibt das Requirements Engineering Reference Model (REM). Die Zielsetzung von REM ist:(1) Die Definition eines Referenzmodells für das Requirements Engineering (RE) mittels Festlegung der Kernmenge von zu entwickelnden RE Artefakten (Arbeitsprodukten im RE) einer Systementwicklung und ihren Abhängigkeiten - das RE Artefaktmodell, und(2) Die Einführung und Anpassung von produkt- und projekt-spezifischen RE Prozessen auf Basis des RE Artefaktmodells.REM ist ...

  3. Capturing Requirements for Autonomous Spacecraft with Autonomy Requirements Engineering

    Science.gov (United States)

    Vassev, Emil; Hinchey, Mike

    2014-08-01

    The Autonomy Requirements Engineering (ARE) approach has been developed by Lero - the Irish Software Engineering Research Center within the mandate of a joint project with ESA, the European Space Agency. The approach is intended to help engineers develop missions for unmanned exploration, often with limited or no human control. Such robotics space missions rely on the most recent advances in automation and robotic technologies where autonomy and autonomic computing principles drive the design and implementation of unmanned spacecraft [1]. To tackle the integration and promotion of autonomy in software-intensive systems, ARE combines generic autonomy requirements (GAR) with goal-oriented requirements engineering (GORE). Using this approach, software engineers can determine what autonomic features to develop for a particular system (e.g., a space mission) as well as what artifacts that process might generate (e.g., goals models, requirements specification, etc.). The inputs required by this approach are the mission goals and the domain-specific GAR reflecting specifics of the mission class (e.g., interplanetary missions).

  4. GRID INFORMATION SECURITY FUNCTIONAL REQUIREMENT

    Directory of Open Access Journals (Sweden)

    Amy Poh Ai Ling

    2011-07-01

    Full Text Available This paper describes the background of smart information infrastructure and the needs for smart grid information security. It introduces the conceptual analysis to the methodology with the application ofhermeneutic circle and information security functional requirement identification. Information security for the grid market cover matters includes automation and communications industry that affects the operation of electric power systems and the functioning of the utilities that manage them and its awareness of this information infrastructure has become critical to the reliability of the power system. Community benefits from of cost savings, flexibility and deployment along with the establishment of wireless communications. However, concern revolves around the security protections for easily accessible devices such as the smart meter and the related communications hardware. On the other hand, the changing points between traditional versus smart grid networking trend and the information security importance on the communication field reflects the criticality of grid information security functional requirement identification. The goal of this paper is to identify the functional requirement and relate its significance addresses to the consumer requirement of an information security of a smart grid. Vulnerabilities may bring forth possibility for an attacker to penetrate a network, make headway admission to control software, alter it to load conditions that destabilize the grid in unpredictable ways. Focusing on the grid information security functional requirement is stepping ahead in developing consumer trust and satisfaction towardsmart grid completeness.

  5. Authorization basis requirements comparison report

    Energy Technology Data Exchange (ETDEWEB)

    Brantley, W.M.

    1997-08-18

    The TWRS Authorization Basis (AB) consists of a set of documents identified by TWRS management with the concurrence of DOE-RL. Upon implementation of the TWRS Basis for Interim Operation (BIO) and Technical Safety Requirements (TSRs), the AB list will be revised to include the BIO and TSRs. Some documents that currently form part of the AB will be removed from the list. This SD identifies each - requirement from those documents, and recommends a disposition for each to ensure that necessary requirements are retained when the AB is revised to incorporate the BIO and TSRs. This SD also identifies documents that will remain part of the AB after the BIO and TSRs are implemented. This document does not change the AB, but provides guidance for the preparation of change documentation.

  6. Triggering requirements for SSC physics

    Energy Technology Data Exchange (ETDEWEB)

    Gilchriese, M.G.D. [Lawrence Berkeley Lab., CA (United States)

    1989-04-01

    Some aspects of triggering requirements for high P{sub T} physics processes at the Superconducting Super Collider (SSC) are described. A very wide range of trigger types will be required to enable detection of the large number of potential physics signatures possible at the SSC. Although in many cases trigger rates are not now well understood, it is possible to conclude that the ability to trigger on transverse energy, number and energy of jets, number and energy of leptons (electrons and muons), missing energy and combinations of these will be required. An SSC trigger system must be both highly flexible and redundant to ensure reliable detection of many new physics processes at the SSC.

  7. Authorization basis requirements comparison report

    International Nuclear Information System (INIS)

    The TWRS Authorization Basis (AB) consists of a set of documents identified by TWRS management with the concurrence of DOE-RL. Upon implementation of the TWRS Basis for Interim Operation (BIO) and Technical Safety Requirements (TSRs), the AB list will be revised to include the BIO and TSRs. Some documents that currently form part of the AB will be removed from the list. This SD identifies each - requirement from those documents, and recommends a disposition for each to ensure that necessary requirements are retained when the AB is revised to incorporate the BIO and TSRs. This SD also identifies documents that will remain part of the AB after the BIO and TSRs are implemented. This document does not change the AB, but provides guidance for the preparation of change documentation

  8. User Expressions Translated Into Requirements

    Directory of Open Access Journals (Sweden)

    Birgitta Bergvall-Kåreborn

    2010-01-01

    Full Text Available Grounding the development of mobile and ubiquitous services on actual needs and behaviors of users, rather than on designers' intuition, is a well-established tradition. However, gathering data about users in different contexts usually results in large amounts of data that have to be analyzed and translated into requirements. This crucial activity and its outcome are often shaped by the preconceptions of the developers or researchers. Despite this subjectivity, the translation process is seldom transparent. The aim of this paper, therefore, is to contribute to the field by presenting a process for translating user expressions into needs and later into requirements using Reiss' taxonomy of human needs. By adopting this process of translation, we were able to identify two hierarchical levels of needs: needs of a service and needs in a service. These two levels provide a transparent bridge between user expressions and system requirements.

  9. Physical requirements in Olympic sailing

    DEFF Research Database (Denmark)

    Bojsen-Møller, J; Larsson, B; Aagaard, Per

    2015-01-01

    Abstract Physical fitness and muscular strength are important performance parameters in Olympic sailing although their relative importance changes between classes. The Olympic format consists of eight yacht types combined into 10 so-called events with total 15 sailors (male and female) in a...... complete national Olympic delegation. The yachts have different requirements with respect to handling, and moreover, each sailor plays a specific role when sailing. Therefore physical demands remain heterogeneous for Olympic sailors. Previous studies have mainly examined sailors where 'hiking' (the task of...... leaning over the side of the yacht to increase righting moment) is the primary requirement. Other than the ability to sustain prolonged quasi-isometric contractions, hiking seems to require significant maximal muscle strength especially in knee extensors, hip flexors and abdominal and lower back muscles...

  10. Airport surface operations requirements analysis

    Science.gov (United States)

    Groce, John L.; Vonbokern, Greg J.; Wray, Rick L.

    1993-01-01

    This report documents the results of the Airport Surface Operations Requirements Analysis (ASORA) study. This study was conducted in response to task 24 of NASA Contract NAS1-18027. This study is part of NASA LaRC's Low Visibility Surface Operations program, which is designed to eliminate the constraints on all-weather arrival/departure operations due to the airport/aircraft ground system. The goal of this program is to provide the capability for safe and efficient aircraft operations on the airport surface during low visibility conditions down to zero. The ASORA study objectives were to (1) develop requirements for operation on the airport surface in visibilities down to zero; (2) survey and evaluate likely technologies; (3) develop candidate concepts to meet the requirements; and (4) select the most suitable concept based on cost/benefit factors.

  11. Project X functional requirements specification

    CERN Document Server

    Holmes, S D; Kephart, R; Kerby, J; Kourbanis, I; Lebedev, V; Mishra, S; Nagaitsev, S; Solyak, N; Tschirhart, R

    2012-01-01

    Project X is a multi-megawatt proton facility being developed to support a world-leading program in Intensity Frontier physics at Fermilab. The facility is designed to support programs in elementary particle and nuclear physics, with possible applications to nuclear energy research. A Functional Requirements Specification has been developed in order to establish performance criteria for the Project X complex in support of these multiple missions, and to assure that the facility is designed with sufficient upgrade capability to provide U.S. leadership for many decades to come. This paper will briefly review the previously described Functional Requirements, and then discuss their recent evolution.

  12. Project X functional requirements specification

    International Nuclear Information System (INIS)

    Project X is a multi-megawatt proton facility being developed to support a world-leading program in Intensity Frontier physics at Fermilab. The facility is designed to support programs in elementary particle and nuclear physics, with possible applications to nuclear energy research. A Functional Requirements Specification has been developed in order to establish performance criteria for the Project X complex in support of these multiple missions, and to assure that the facility is designed with sufficient upgrade capability to provide U.S. leadership for many decades to come. This paper will briefly review the previously described Functional Requirements, and then discuss their recent evolution.

  13. Protein requirement in critical illness.

    Science.gov (United States)

    Hoffer, Leonard John

    2016-05-01

    How much protein do critically ill patients require? For the many decades that nutritional support has been used there was a broad consensus that critically ill patients need much more protein than required for normal health. Now, however, some clinical investigators recommend limiting all macronutrient provision during the early phase of critical illness. How did these conflicting recommendations emerge? Which of them is correct? This review explains the longstanding recommendation for generous protein provision in critical illness, analyzes the clinical trials now being claimed to refute it, and concludes with suggestions for clinical investigation and practice. PMID:26914090

  14. Johnson Noise Thermometry System Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Britton Jr, Charles L [ORNL; Roberts, Michael [ORNL; Ezell, N Dianne Bull [ORNL; Qualls, A L [ORNL; Holcomb, David Eugene [ORNL

    2013-01-01

    This document is intended to capture the requirements for the architecture of the developmental electronics for the ORNL-lead drift-free Johnson Noise Thermometry (JNT) project conducted under the Instrumentation, Controls, and Human-Machine Interface (ICHMI) research pathway of the U.S. Department of Energy (DOE) Advanced Small Modular Reactor (SMR) Research and Development (R&D) program. The requirements include not only the performance of the system but also the allowable measurement environment of the probe and the allowable physical environment of the associated electronics. A more extensive project background including the project rationale is available in the initial project report [1].

  15. Buddy Tag CONOPS and Requirements.

    Energy Technology Data Exchange (ETDEWEB)

    Brotz, Jay Kristoffer [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Deland, Sharon M. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2015-12-01

    This document defines the concept of operations (CONOPS) and the requirements for the Buddy Tag, which is conceived and designed in collaboration between Sandia National Laboratories and Princeton University under the Department of State Key VerificationAssets Fund. The CONOPS describe how the tags are used to support verification of treaty limitations and is only defined to the extent necessary to support a tag design. The requirements define the necessary functions and desired non-functional features of the Buddy Tag at a high level

  16. Magnet requirements for experimental areas

    International Nuclear Information System (INIS)

    The magnet requirements for the experimental areas of the TRIUMF KAON Factory are varied and demanding. In the target areas the magnets will be located in radiation fields up to 10E7 rad/h and will also absorb thermal loads from beam heating up to several W/cm3. In this operating environment the magnets must be reliable and capable of remote installation and servicing. Other magnet designs include Lambertson septum magnets for beam splitting in the proton switchyard and superconducting or superferric magnets in the secondary channels and detectors. This paper describes some of these magnet requirements and presents some preliminary ideas on their designs

  17. 78 FR 78589 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards

    Science.gov (United States)

    2013-12-26

    .... Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Final... 230 Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards... Administrative Requirements, Cost Principles, and Audit Requirements for Federal awards. These modifications...

  18. Snubber qualification and test requirements

    Energy Technology Data Exchange (ETDEWEB)

    Onesto, A.T.; Larson, D.A.

    1983-05-02

    The use of snubbers for safety related piping systems has increased significantly during the last decade. A corresponding increase in snubber requirements (criteria) has also occurred. A review of these criteria indicates inconsistencies and contradictions, and reflects how rapidly knowledge and experience has been gained and applied. This study reviews and summarizes existing criteria, illustrates inconsistencies and recommends research to resolve conflicts.

  19. ISEE-3 Microwave Filter Requirements

    Science.gov (United States)

    Galvez, J. L.; Marlin, H.; Stanton, P.

    1984-01-01

    The 64 m subnet is committed to support the International Sun Earth Explorer (ISEE-3) spacecraft. The uplink and one of the downlink frequencies will be respectively, 2090 and 2217 MHz. As these two frequencies fall outside the normal DSN transmit and receive bands, the 64-m antennas present new filter requirements, which are analyzed.

  20. Water Requirements Of Irrigated Garlic

    Science.gov (United States)

    A replicated field trial was conducted on the West side of the San Joaquin Valley to determine the crop coefficient and water requirements of irrigated garlic. Irrigation systems used included flood irrigation, subsurface drip irrigation, and surface drip irrigation. Irrigation levels were set at 5...

  1. Mineral requirements of dairy sheep

    OpenAIRE

    Giuseppina Camboni; Walter Pinna; Federico Infascelli; Giuseppe Moniello

    2010-01-01

    This paper reviews the major (Calcium, Phosphorus, Potassium, Sodium, Chlorine, Sulphur, Magnesium) and the trace  elements (Iron, Copper, Cobalt, Iodine, Manganese, Zync, Molybdenum, Selenium) that play an essential role in animal  metabolism. For each one the authors indicate not only the function, but also the more recent advances in terms of  daily requirements for dairy sheep. 

  2. Requirements management: A CSR's perspective

    Science.gov (United States)

    Thompson, Joanie

    1991-01-01

    The following subject areas are covered: customer service overview of network service request processing; Customer Service Representative (CSR) responsibility matrix; extract from a sample Memorandum of Understanding; Network Service Request Form and its instructions sample notification of receipt; and requirements management in the NASA Science Internet.

  3. SRS control system upgrade requirements

    International Nuclear Information System (INIS)

    This document defines requirements for an upgrade of the Sodium Removal System (SRS) control system. The upgrade is being performed to solve a number of maintainability and operability issues. The upgraded system will provide the same functions, controls and interlocks as the present system, and in addition provide enhanced functionality in areas discussed in this document

  4. The Present Requirements on Bank Prudence. Publicity Requirements and Sanctions

    OpenAIRE

    Gheorghe Carmen Adriana

    2012-01-01

    Requirements on banking activity impose regulation of specific issues concerning both the authorisation and the operation, and also ceasing the bank activity. This enforcement originates from the objectives pursued by the National Bank of Romania as own policy, but also as a separate member of the European financial structures. The analysis aims to identify, without exhaustive study, the intrinsic correlations of essential notions for banking field - prudence, prudential supervision, internat...

  5. Conversion of dependability deterministic requirements into probabilistic requirements

    International Nuclear Information System (INIS)

    This report concerns the on-going survey conducted jointly by the DAM/CCE and NRE/SR branches on the inclusion of dependability requirements in control and instrumentation projects. Its purpose is to enable a customer (the prime contractor) to convert into probabilistic terms dependability deterministic requirements expressed in the form ''a maximum permissible number of failures, of maximum duration d in a period t''. The customer shall select a confidence level for each previously defined undesirable event, by assigning a maximum probability of occurrence. Using the formulae we propose for two repair policies - constant rate or constant time - these probabilized requirements can then be transformed into equivalent failure rates. It is shown that the same formula can be used for both policies, providing certain realistic assumptions are confirmed, and that for a constant time repair policy, the correct result can always be obtained. The equivalent failure rates thus determined can be included in the specifications supplied to the contractors, who will then be able to proceed to their previsional justification. (author), 8 refs., 3 annexes

  6. Grading of quality assurance requirements

    International Nuclear Information System (INIS)

    The present Manual provides guidance and illustrative examples for applying a method by which graded quality assurance requirements may be determined and adapted to the items and services of a nuclear power plant in conformance with the requirements of the IAEA Nuclear Safety Standards (NUSS) Code and Safety Guides on quality assurance. The Manual replaces the previous publication IAEA-TECDOC-303 on the same subject. Various methods of grading quality assurance are available in a number of Member States. During the development of the present Manual it was not considered practical to attempt to resolve the differences between those methods and it was preferred to identify and benefit from the good practices available in all the methods. The method presented in this Manual deals with the aspects of management, documentation, control, verification and administration which affect quality. 1 fig., 4 tabs

  7. Aligning seminars with Bologna requirements

    DEFF Research Database (Denmark)

    Lueg, Klarissa; Lueg, Rainer; Lauridsen, Ole

    2015-01-01

    Changes in public policy, such as the Bologna Process, require students to be equipped with multifunctional competencies to master relevant tasks in unfamiliar situations. Achieving this goal might imply a change in many curricula toward deeper learning. As a didactical means to achieve deep...... learning results, the authors suggest reciprocal peer tutoring (RPT); as a conceptual framework the authors suggest the SOLO (Structure of Observed Learning Outcomes) taxonomy and constructive alignment as suggested by Biggs and Tang. Our study presents results from the introduction of RPT in a large...... course. The authors find that RPT produces satisfying learning outcomes, active students, and ideal constructive alignments of the seminar content with the exam, the intended learning outcomes, and the requirements of the Bologna Process. Our data, which comprise surveys and evaluations from both faculty...

  8. CMS Requirements for the Grid

    Institute of Scientific and Technical Information of China (English)

    K.Holtman; J.Amundson; 等

    2001-01-01

    CMS physicists need to seamlessly access their experimental data and results,independent of location and storage medium,in order to focus on the exploration for the new physics signals arther than the complexities of worldwide data management .In order to achieve this goal,CMS has adopted a tiered worldwide computing model which will incorporate emerging Grid technology.CMS has started to use Grid tools for data processing,replication and migration,Important Grid components are expected to be delivered by the Data Grid projects.like projects,CMS has created a set of long-term requirements to the Grid projects.These requirements are presented and discussed.

  9. DRFM requirements demand innovative technology

    Science.gov (United States)

    Webber, G.; Culp, J.; Robinson, M.

    1986-02-01

    In the context of the operation of emerging electronic countermeasures (ECM) jamming systems, a coherent means of capturing a received threat waveform is needed. The present paper is concerned with digital RF memory (DRFM) technology, which can be used to satisfy the involved requirements, taking into account high-performance multibit systems currently under development. System-driven requirements are considered along with a DRFM design implementation sampler/digitizer, Mux/Demux and memory, and packaging. It is pointed out that one of the most promising approaches for DRFM packaging involves surface mount technology (SMT). The development of low power and highspeed GaAs memory will provide DRFM designers with alternative options to the solution of power dissipation problems.

  10. Documentation requirements for radiation sterilization

    DEFF Research Database (Denmark)

    Miller, A.

    1995-01-01

    Several standards are recently approved or are under development by the standard organizations ISO and CEN in the field of radiation sterilization. Particularly in Europe these standards define new requirements on some issues and on other issues they emphasize the necessary documentation for appr......Several standards are recently approved or are under development by the standard organizations ISO and CEN in the field of radiation sterilization. Particularly in Europe these standards define new requirements on some issues and on other issues they emphasize the necessary documentation...... for approval of radiation sterilized products. The impact of these standards on the radiation sterilization is discussed, with special attention given to a few special issues, mainly traceability and uncertainty of measurement results....

  11. Integrated care requires integrated supervision

    OpenAIRE

    Ketelaars, Corry

    2011-01-01

    Introduction: Given recent developments in integrated care, it is becoming increasingly important for the Dutch Health Care Inspectorate to direct its supervision in a way that may help speed up the implementation of integrated care.Description of care practice: Since the implementation of integrated care for chronic patients is facing obstacles, alternative methods are required to ensure that the implementation process does not run into any delays. By applying a risk-based approach to integr...

  12. Faulty assumptions for repository requirements

    International Nuclear Information System (INIS)

    Long term performance requirements for a geologic repository for spent nuclear fuel and high-level waste are based on assumptions concerning water use and subsequent deaths from cancer due to ingesting water contaminated with radio isotopes ten thousand years in the future. This paper argues that the assumptions underlying these requirements are faulty for a number of reasons. First, in light of the inevitable technological progress, including efficient desalination of water, over the next ten thousand years, it is inconceivable that a future society would drill for water near a repository. Second, even today we would not use water without testing its purity. Third, today many types of cancer are curable, and with the rapid progress in medical technology in general, and the prevention and treatment of cancer in particular, it is improbable that cancer caused by ingesting contaminated water will be a significant killer in the far future. This paper reviews the performance requirements for geological repositories and comments on the difficulties in proving compliance in the face of inherent uncertainties. The already tiny long-term risk posed by a geologic repository is presented and contrasted with contemporary every day risks. A number of examples of technological progress, including cancer treatments, are advanced. The real and significant costs resulting from the overly conservative requirements are then assessed. Examples are given of how money (and political capital) could be put to much better use to save lives today and in the future. It is concluded that although a repository represents essentially no long-term risk, monitored retrievable dry storage (above or below ground) is the current best alternative for spent fuel and high-level nuclear waste

  13. Mineral requirements of dairy sheep

    Directory of Open Access Journals (Sweden)

    Giuseppina Camboni

    2010-01-01

    Full Text Available This paper reviews the major (Calcium, Phosphorus, Potassium, Sodium, Chlorine, Sulphur, Magnesium and the trace  elements (Iron, Copper, Cobalt, Iodine, Manganese, Zync, Molybdenum, Selenium that play an essential role in animal  metabolism. For each one the authors indicate not only the function, but also the more recent advances in terms of  daily requirements for dairy sheep. 

  14. Requirements and information metadata system

    OpenAIRE

    Beckman, Erin M.

    2007-01-01

    CHDS State/Local This thesis proposes an adoption of a data schema called RIMS (Requirements and Information Metadata System) developed as a pilot project in the Pittsburgh Field Office of the FBI and sets out to determine if RIMS could be an effective and efficient method to capture, catalogue and retrieve intelligence information within the Federal Bureau of Investigation (FBI). RIMS would enhance the search platform used by FBI analysts and investigators who gather or data mine exi...

  15. Space flight requires nuclear energy

    International Nuclear Information System (INIS)

    To be able to solve its future tasks, space flight needs nuclear energy: manned space flight to the Mars is almost unthinkable without nuclear propulsion, and orbital nuclear power plants will be required for the power supply of high-capacity satellites or large space stations. Nuclear energy needs space flight: a nuclear power plant on the moon does not bother man because of the high natural radiation exposure existing there, and could contribute to terrestrial power supply. (orig./HSCH)

  16. EMC Part Ⅱ Regulatory Requirements

    Institute of Scientific and Technical Information of China (English)

    JohnWong

    2005-01-01

    As described in the Part I, the goal of electromagnetic compatibility, or EMC, is to design electronic systems that are electromagnetically compatible with their environment. EMC requirements exist so that electronic systems designers have a set of guidelines that explain the limits of what is considered electromagnetically compatible. There is not, however, one allencompassing set of EMC guidelines. Instead, EMC guidelines are created by individual product manufacturers,

  17. Host City Contract operational requirements

    OpenAIRE

    2015-01-01

    The Host City Contract - Operational Requirements (the “HCC Operational Requirements”) are an important part of the Host City Contract, detailing a set of core elements for the project, which provide Olympic quality conditions for the athletes and all participants, while at the same time allowing potential host cities to responsibly match their Games concepts to their own sport, economic, social, and environmental long-term planning needs.

  18. Material Requirement Planning – MRP

    OpenAIRE

    Atanasova-Pacemska, Tatjana; Vasileva, Liljana

    2013-01-01

    Managing inventory is one of the most important logistic tasks. Many companies are faced with problems that hinder finding the optimal policy of managing inventory. Given the fact that the problem with inventory nowadays is more prominent in the operation of enterprises, studied in this paper will be contemporary models of inventory, where emphasis will be placed on management models based on inventory planning needs material (Material Requirement Planning -MRP). In domestic professional l...

  19. GRID INFORMATION SECURITY FUNCTIONAL REQUIREMENT

    OpenAIRE

    Amy Poh Ai Ling; Mukaidono Masao

    2011-01-01

    This paper describes the background of smart information infrastructure and the needs for smart grid information security. It introduces the conceptual analysis to the methodology with the application ofhermeneutic circle and information security functional requirement identification. Information security for the grid market cover matters includes automation and communications industry that affects the operation of electric power systems and the functioning of the utilities that manage them ...

  20. Digestible lysine requirements of broilers

    Directory of Open Access Journals (Sweden)

    LEP Bernal

    2014-03-01

    Full Text Available Modern broilers have been submitted to continuous genetic improvement, and therefore, their nutritional requirements must be constantly updated to ensure their performance. Two experiments were carried out to evaluate different digestible lysine levels for starter (1021 days and grower (22-35 days phases. The experiments were carried out with male and female Cobb 500 broilers, distributed according to a randomized block experimental design in a 5x2 factorial arrangement (5 increasing digestible lysine levels x 2 sexes, totaling 10 treatments, with 8 replicates of 22 and 20 birds during the starter and grower phase, respectively. Digestible lysine levels of 1.06, 1.12, 1.18, 1.24, and 1.30 were used in the starter diets (10-21 days and 0.9, 0.98, 1.04, 1.10, and 1.16% in the grower diets (22-35 days. Based on the statistical analyses of the evaluated performance parameters, digestible lysine requirements for maximum performance were determined as 1.22% for males and 1.24% for females in the starter phase, and 1.16% for both sexes in the grower phase. Carcass and performance results indicate that digestible lysine requirements vary with sex and evaluated production parameter. Considering the most relevant broiler production parameters, in 22- to 35-d-old males, digestible lysine requirement for breast meat yield (1.16% was higher than those for feed conversion ratio (1.07% and weight gain (1.05%.

  1. Requirements for Model Development Environments

    OpenAIRE

    Balci, Osman

    1983-01-01

    This paper deals with the initial phase of our ongoing research project on the Definition of a Discrete Event Simulation MDE which started on 1 June 1983. The first phase of the rapid prototyping approach we are using in designing the MDE involves the requirements specification. A literature review revealed eleven current problems in modeling. To address these problems, a MDE was identified as composed of four layers: (1) hardware and operating system, (2) kernel MDE, (3) minimal MDE, and...

  2. Requirements for light water reactors

    International Nuclear Information System (INIS)

    The EUR (European Utilities Requirements) is an organization founded in 1991 whose aim was to write down the European specifications and requirements for the future reactors of third generation. EUR gathers most of the nuclear power producers of Europe. The EUR document has been built on the large and varied experience of EUR members and can be used to elaborate invitations to tender for nuclear projects. 4000 requirements only for the nuclear part of the plant are listed, among which we have: -) the probability of core meltdown for a reactor must be less than 10-6 per year, -) the service life of every component that is not replaceable must be 60 years, -) the capacity of the spent fuel pool must be sufficient to store 10-15 years of production without clearing out. The EUR document is both open and complete: every topic has been considered, it does not favor any type of reactor but can ban any technology that is too risky or has an unfavourable feedback experience. The assessment of the conformity with the EUR document of 7 reactor projects (BWR 90/, EPR, EP1000, SWR1000, ABWR, AP1000 and VVER-AES-92) has already be made. (A.C.)

  3. Lunar Human Research Requirements (LHRR)

    Science.gov (United States)

    Denkins, Pamela

    2009-01-01

    Biomedical research will be conducted during transit and on the surface of the Moon to prepare for extended stays on the Moon and to prepare for the exploration of Mars. The objective of the Human Research Program (HRP) is to preserve the health and enhance performance of astronaut explorers. Specific objectives of the HRP include developing the knowledge, capabilities, and necessary countermeasures and technologies in support of human space exploration; focusing on mitigating the highest risks to crew health and performance; and defining and improving human spaceflight medical, environmental, behavioral, and human factors standards. This document contains a detailed description of the resource accommodations, interfaces, and environments to be provided by the Constellation Program (CxP) to support the HRP research in transit and on the lunar surface. Covered, specifically, are the requirements for mass and volume transport; crew availability; ground operations, baseline data collection, and payload processing; power, and data. Volumes and mass are given for transport of conditioned samples only. They do not account for the engineering solution that the Constellation Program will implement (refrigerator/freezer volume/mass). This document does not account for requirements on the Orion vehicle for transportation to and from the International Space Station (ISS). The ISS Program has supplied requirements for this mission.

  4. Physics and detector simulation requirements

    International Nuclear Information System (INIS)

    The Superconducting Super Collider Laboratory (SSCL) has computing requirements in several different areas at several levels of intensity. These needs vary from word processing and spreadsheet calculations on one end of the spectrum to a need for thousands of hours of super-computer time on the other. These needs and their focus will continue to develop and change throughout the life cycle of the laboratory. This document describes the computing environment needed to meet the requirements for high energy physics (HEP) Monte Carlo calculations for the simulation of SSCL physics and detectors. Two types of Monte Carlo simulations must be done: the first, to simulate the physics of the interactions that will occur at the SSCL, and the second, to determine the simulated response of the detectors that will study these interactions. The calculations to be performed in each simulation are lengthy and detailed, and could require many months per run on a VAX 11/780 and may produce several gigabyte of data per run. Consequently, a distributed computing environment of several networked high-speed computing engines is envisioned to meet these needs. These networked computers would form the basis of a centralized facility for SSCL physics and detector simulation work. It has been estimated that this computing facility will need to grow to approximately 4000 MIPS of computing horse-power by 1992

  5. Technology Requirements for Information Management

    Science.gov (United States)

    Graves, Sara; Knoblock, Craig A.; Lannom, Larry

    2002-01-01

    This report provides the results of a panel study conducted into the technology requirements for information management in support of application domains of particular government interest, including digital libraries, mission operations, and scientific research. The panel concluded that it was desirable to have a coordinated program of R&D that pursues a science of information management focused on an environment typified by applications of government interest - highly distributed with very large amounts of data and a high degree of heterogeneity of sources, data, and users.

  6. Superluminal travel requires negative energies

    OpenAIRE

    Olum, Ken D.

    1998-01-01

    I investigate the relationship between faster-than-light travel and weak-energy-condition violation, i.e., negative energy densities. In a general spacetime it is difficult to define faster-than-light travel, and I give an example of a metric which appears to allow superluminal travel, but in fact is just flat space. To avoid such difficulties, I propose a definition of superluminal travel which requires that the path to be traveled reach a destination surface at an earlier time than any neig...

  7. Requirements on high resolution detectors

    Energy Technology Data Exchange (ETDEWEB)

    Koch, A. [European Synchrotron Radiation Facility, Grenoble (France)

    1997-02-01

    For a number of microtomography applications X-ray detectors with a spatial resolution of 1 {mu}m are required. This high spatial resolution will influence and degrade other parameters of secondary importance like detective quantum efficiency (DQE), dynamic range, linearity and frame rate. This note summarizes the most important arguments, for and against those detector systems which could be considered. This article discusses the mutual dependencies between the various figures which characterize a detector, and tries to give some ideas on how to proceed in order to improve present technology.

  8. General lighting requirements for photosynthesis

    Science.gov (United States)

    Geiger, Donald R.

    1994-01-01

    This paper presents data that suggests some criteria for evaluating growth chamber and greenhouse lighting. A review of the general lighting requirements for photosynthesis reveals that four aspects of light are important: irradiance, quality, timing, and duration. Effective lighting should produce plants that perform according to the goals of the project. For example, for physiological studies the plants probably should exhibit morphology and physiology similar to that found in field-grown plants. For other projects the criteria will obviously be set according to the reason for raising the plants.

  9. Requirements and the baseline plan

    CERN Document Server

    Qureshi, M Rizwan Jameel

    2012-01-01

    For each software project a plan is developed, according to a documented procedure, that covers the software activities and commitments. The requirements allocated to software form the basis for the software development plan. Estimates for critical computer resources are documented, reviewed, and agreed to. All affected groups and individuals understand the estimates and plans and commit to support them. Senior management reviews the estimates and plans before external commitments are made. Software risks associated with the cost, resources, schedule, and technical aspects of the project are identified and evaluated, and contingencies are documented. Planning and estimation data are collected for use in planning subsequent projects and for input in management oversight review meetings.

  10. Materials requirements for fusion reactors

    International Nuclear Information System (INIS)

    Once the physics of fusion devices is understood, one or more experimental power reactors (EPR) are planned which will produce net electrical power. The structural material for the device will probably be a modification of an austenitic stainless steel. Unlike fission reactors, whose pressure boundaries are subjected to no or only light irradiation, the pressure boundary of a fusion reactor is subjected to high atomic displacement-damage and high production rates of transmutation products, e.g., helium and hydrogen. The design data base must include irradiated materials. Since in situ testing to obtain tensile, fatigue, creep, crack-growth, stress-rupture, and swelling data is currently impossible for fusion reactor conditions, a program of service-temperature irradiations in fission reactors followed by postirradiation testing, simulation of fusion conditions, and low-fluence 14 MeV neutron-irradiation tests are planned. For the Demonstration Reactor (DEMO) expected to be built within ten years after theEPR, higher heat fluxes may require the use of refractory metals, at least for the first 20 cm. A partial data base may be provided by high-flux 14 MeV neutron sources being planned. Many materials other than those for structural components will be required in the EPR and DEMO. These include superconducting magnets, insulators, neutron reflectors and shields, and breeding materials. The rest of the device should utilize conventional materials except that portion involved in tritium confinement and recovery

  11. Shielding requirements in helical tomotherapy

    International Nuclear Information System (INIS)

    Helical tomotherapy is a relatively new intensity-modulated radiation therapy (IMRT) treatment for which room shielding has to be reassessed for the following reasons. The beam-on-time needed to deliver a given target dose is increased and leads to a weekly workload of typically one order of magnitude higher than that for conventional radiation therapy. The special configuration of tomotherapy units does not allow the use of standard shielding calculation methods. A conventional linear accelerator must be shielded for primary, leakage and scatter photon radiations. For tomotherapy, primary radiation is no longer the main shielding issue since a beam stop is mounted on the gantry directly opposite the source. On the other hand, due to the longer irradiation time, the accelerator head leakage becomes a major concern. An analytical model based on geometric considerations has been developed to determine leakage radiation levels throughout the room for continuous gantry rotation. Compared to leakage radiation, scatter radiation is a minor contribution. Since tomotherapy units operate at a nominal energy of 6 MV, neutron production is negligible. This work proposes a synthetic and conservative model for calculating shielding requirements for the Hi-Art II TomoTherapy unit. Finally, the required concrete shielding thickness is given for different positions of interest

  12. Nuclear Energy, Long Term Requirements

    International Nuclear Information System (INIS)

    There are serious warnings about depletion of oil and gas and even more serious warnings about dangers of climate change caused by emission of carbon dioxide. Should developed countries be called to replace CO2 emitting energy sources as soon as possible, and the time available may not be longer then few decades, can nuclear energy answer the call and what are the requirements? Assuming optimistic contribution of renewable energy sources, can nuclear energy expand to several times present level in order to replace large part of fossil fuels use? Paper considers intermediate and long-term requirements. Future of nuclear power depends on satisfactory answers on several questions. First group of questions are those important for near and intermediate future. They deal with economics and safety of nuclear power stations in the first place. On the same time scale a generally accepted concept for radioactive waste disposal is also required. All these issues are in the focus of present research and development. Safer and more economical reactors are targets of international efforts in Generation IV and INPRO projects, but aiming further ahead these innovative projects are also addressing issues such as waste reduction and proliferation resistance. However, even assuming successful technical development of these projects, and there is no reason to doubt it, long term and large-scale nuclear power use is thereby not yet secured. If nuclear power is to play an essential role in the long-term future energy production and in reduction of CO2 emission, than several additional questions must be replied. These questions will deal with long-term nuclear fuel sufficiency, with necessary contribution of nuclear power in sectors of transport and industrial processes and with nuclear proliferation safety. This last issue is more political then technical, thus sometimes neglected by nuclear engineers, yet it will have essential role for the long-term prospects of nuclear power. The

  13. Requirements and Markets for Nanoelectronics

    Science.gov (United States)

    Hoefflinger, Bernd

    The semiconductor market grew 2010 by 70Bio. against 2009, more than in the previous 9 years taken together, and the semiconductor industry launched the biggest investment program in its history with 100Bio. over a 2-year period. This was the overture to a decade with great potential and great challenges. We look at the market segments and the required electronic functions, and we highlight four product and service areas: Approaching 6 Billion mobile-phone subscribers Access to education for any child One Carebot (personal robot) per family Efficient and safe personal mobility. At the level of over four billion active mobile phones 2010, it is clear that mobile electronic companions have become the drivers of nanoelectronic innovations with growth only limited by the creation and support of new, attractive features and services. Energy, bandwidth, size and weight requirements of these consumer products provide the largest pressure for System-on-Chip (SoC) architectures. Other exemplary new products are selected for their significance, some for their lengthy path into the market. Health care is such an example: The non-invasive glucose sensor and the portable ECG recorder" with automatic, neuroprocessor-driven event detection in the size of a quarter would serve hundreds of millions of people. Nanoelectronics for self-guided health is an area of public policy in view of the cost of "a posteriori" medical care. Access to information and education for any child/student will be provided by 1 tablets where service contracts and the spin-offs from surfing and cloud-computing will generate the revenue. Personal robots, coined by the ageing Japanese nation as the key product after the PC and ridiculed by others, will arrive as carebots for education, entertainment, rehabilitation, and home-service, accepted as a large-scale need by 2020 in most developed countries including China. Accident prevention systems on rail and road already would make millions of units per year

  14. 24 CFR 234.501 - Eligibility requirements.

    Science.gov (United States)

    2010-04-01

    ... CONDOMINIUM OWNERSHIP MORTGAGE INSURANCE Eligibility Requirements-Projects-Conversion Individual Sales Units § 234.501 Eligibility requirements. The requirements set forth in 24 CFR part 200, subpart A, apply...

  15. SLI Thermal Imaging Requirements Evaluation

    Science.gov (United States)

    Hoffman, E. H.; Woody, L. M.; Wirth, S. M.; Smith, D. S.

    2015-12-01

    The Landsat program has provided a continuous record of global terrestrial imagery since 1972. This data record is an invaluable resource for determining long term trends and monitoring rates of change in land usage, forest health, water quality, and glacier retreat. In 2014, the National Aeronautics and Space Administration (NASA), supported by the United States Geological Survey (USGS), initiated the sustainable land imaging (SLI) architecture study to develop an affordable system design for acquiring future terrestrial imagery compatible with the existing Landsat data record. The principal objective has been to leverage recent advances in focal plane technologies to enable smaller, lower-cost instruments and launch options. We present an evaluation of the trade space implied by the SLI thermal imaging requirements as well as the performance potential of enabling technologies. Multiple approaches, each incorporating measured performance data for state-of-the-art detectors, are investigated to simultaneously optimize instrument mass and volume, spatial response, radiometric sensitivity, and radiometric uncertainty.

  16. Pyridoxine requirements of channel catfish.

    Science.gov (United States)

    Andrews, J W; Murai, T

    1979-04-01

    In 20 and 12 week feeding trials, channel catfish fingerlings were fed purified diets containing five levels (0, 5, 10, 20, and 30 mg/kg) and six levels (0, 1, 2, 5, 10, and 20 mg/kg) of supplemental pyridoxine hydrochloride. Fish fed unsupplemented diets (pyridoxine content of 1.2 mg/kg) were characterized by anoxeria, nervous disorders, tetany, greenish-blue body coloration, and eventual mortality. Anemia, which has been reported in pyridoxine deficient salmonids, was not observed in pyridoxine deficient catfish. However, a microcytic, normochromic anemia was observed in groups fed high dietary levels of pyridoxine (20 mg/kg or greater). The dietary pyridoxine level required for maximal growth was approximately 3 mg/kg of diet. All other deficiency signs were prevented by 2.2 mg/kg of diet. PMID:430257

  17. Requirements engineering for digital health

    CERN Document Server

    Thümmler, Christoph; Gavras, Anastasius

    2015-01-01

    Healthcare and well-being have captured the attention of established software companies, start-ups, and investors. Software is starting to play a central role for addressing the problems of the aging society and the escalating cost of healthcare services. Enablers of such digital health are a growing number of sensors for sensing the human body and communication infrastructure for remote meetings, data sharing, and messaging. The challenge that lies in front of us is how to effectively make use of these capabilities, for example to empower patients and to free the scarce resources of medical personnel. Requirements engineering is the process by which the capabilities of a software product are aligned with stakeholder needs and a shared understanding between the stakeholders and development team established. This book provides guide for what to look for and do when inquiring and specifying software that targets healthcare and well-being, helping readers avoid the pitfalls of the highly regulated and sensible h...

  18. A Framework for Requirements Triage Process

    OpenAIRE

    Veeramachaneni, Ramya Chowdary; Uppalapati, Niroopa

    2011-01-01

    ABSTRACT Context: Requirements triage is a crucial activity in requirements engineering process for market-driven products. Triage deals with selection of appropriate requirements from large number of requirements for particular release plan. If triage is not performed initially, selection and management of a large number of requirements would be difficult in requirements engineering process. In market-driven product development triage is followed by estimation and prioritization of requireme...

  19. Discourse Structure Analysis for Requirement Mining

    OpenAIRE

    Juyeon Kang; Patrick Saint-dizier

    2014-01-01

    In this work, we first introduce two main approaches to writing requirements and then propose a method based on Natural Language Processing to improve requirement authoring and the overall coherence, cohesion and organization of requirement documents. We investigate the structure of requirement kernels, and then the discourse structure associated with those kernels. This will then enable the system to accurately extract requirements and their related contexts from texts (called requirement mi...

  20. Analysing the Assumed Benefits of Software Requirements

    OpenAIRE

    Ellis-Braithwaite, Richard

    2013-01-01

    Often during the requirements engineering (RE) process, the value of a requirement is assessed, e.g., in requirement prioritisation, release planning, and trade-off analysis. In order to support these activities, this research evaluates Goal Oriented Requirements Engineering (GORE) methods for the description of a requirement's value. Specifically, we investigate the goal-to-goal contribution relationship for its ability to demonstrate the value of a requirement, and propose that it is enrich...

  1. Requirements for an energy policy

    International Nuclear Information System (INIS)

    The central issue facing the US today lies in the rise of oil imports. No supergiant (5 billion barrels) oil discoveries have been made in the US. Production from existing fields is declining. The 1985-86 oil price collapse from $26 to less than $15 per barrel had a disastrous effect on the budgets of smaller oil companies which do most of the exploring, and on the service industry. Budgets for overseas exploration has been generally sustained. Oil prices are not expected to sustain domestic exploration. Gulf oil sources will, in the next five years, supply some 75 percent of all oil in international trade. Without an energy policy, involvement in Middle East oil will grow exponentially, as will the needs of others for Gulf oil. The natural gas situation is different, with a spare producing capacity of one trillion cubic feet this year, which could double next year. Natural gas deregulation has created an unbelievable mess in the requirements of producers/suppliers and purchasers to have dependable business arrangements. Coal is plentiful and will be until the end of time. Public opposition to emission problems and the greenhouse effect are an obstacle to greater use of coal. The nuclear option may be dead, with no new orders since 1978. Statistics are provided on proven world reserves of conventional crude oil, recoverable heavy oils, tar sands, and shale oil; which indicates for the long term an ability to transform the Geopolitics of oil away from the middle east. Energy options require energy R ampersand D, use of Alaskan gas, conservation and efficiency in energy use, strategic reserves, close energy relations with allies, and a government-industry link which insures meeting the US oil needs from the Western Hemisphere

  2. [Educational requirements of younger psychiatrists].

    Science.gov (United States)

    Rask, P H; Nielsen, B; Lolk, A; Brødsgaard, M A; Hansen, P E; Knudsen, L; Krarup, G; Lien, K; Refshammer, C M

    1993-05-24

    In order to define the requirements junior medical staff in postgraduate psychiatric training would wish to make for future postgraduate training in adult psychiatry, a questionnaire with 66 questions was sent in June 1990 to postgraduate trainees at all departments of child psychiatry and adult psychiatry in the country. Response was anonymous. The article deals with the responses from 264 persons either intending to undergo specialist training in adult psychiatry or having already completed it. Sixty-four percent stated a need for better individual clinical guidance. The majority stated that eight hours every week should be earmarked for formal tuition and research (two hrs clinical tuition, two hrs theory, two hrs supervision in psychotherapy, and two hrs for research). On average, the trainees had used 4200 DKK of their own income and four free days on courses over the previous year. Twenty-four months was proposed as adequate for an introductory appointment. The majority held that appointments should be made on the basis of the traditional curriculum vitae (82%) and a personal interview (86%), while about 20% believed that written or oral references should also be a requirement. Sixty-nine percent believed that selection of applicants for teaching appointments should be made locally with central supervision. Twenty-six percent felt they had been passed over in appointment situations, and 68% claimed it was due to nepotism. Recommendations for modifications of the future postgraduate training according to the responses are proposed, and it is concluded that earmarked resources are necessary, if the intention in the educational reform now in progress is to be realized. PMID:8316994

  3. Cold vacuum drying facility design requirements

    International Nuclear Information System (INIS)

    This document provides the detailed design requirements for the Spent Nuclear Fuel Project Cold Vacuum Drying Facility. Process, safety, and quality assurance requirements and interfaces are specified

  4. Cold vacuum drying facility design requirements

    Energy Technology Data Exchange (ETDEWEB)

    IRWIN, J.J.

    1999-07-01

    This document provides the detailed design requirements for the Spent Nuclear Fuel Project Cold Vacuum Drying Facility. Process, safety, and quality assurance requirements and interfaces are specified.

  5. REQUIREMENT PRODUCT CONFIGURATION IN MASS CUSTOMIZATION

    Institute of Scientific and Technical Information of China (English)

    Wang Xin; Tan Jianrong; Zhang Shuyou; Wu Peining

    2005-01-01

    On the basis of researching on requirement product configuration in mass customization, the concept of product family requirement class (PFRC) and requirement-matching template are put forward. A case-based requirement product configuration (CB-RPC) model and corresponding requirement product model are established. The result of requirement product configuration is obtained by using the method of two-level similar matching. In addition, the effect of the method on requirement responding is analyzed. Finally, the model and the method given are applied in elevator industry, and have improved the enterprise's ability of rapid responding to customer's requirements.

  6. Three arguments against prescription requirements.

    Science.gov (United States)

    Flanigan, Jessica

    2012-10-01

    In this essay, I argue that prescription drug laws violate patients' rights to self-medication. Patients have rights to self-medication for the same reasons they have rights to refuse medical treatment according to the doctrine of informed consent (DIC). Since we should accept the DIC, we ought to reject paternalistic prohibitions of prescription drugs and respect the right of self-medication. In section 1, I frame the puzzle of self-medication; why don't the same considerations that tell in favour of informed consent also justify a right of self-medication? In section 2, I show that the prescription drug system was historically motivated by paternalism. In section 3, I outline the justifications for the DIC in more detail. I show that consequentialist, epistemic, and deontic considerations justify the DIC. In sections 4-6, I argue that these considerations also justify rights of self-medication. I then propose that rights of self-medication require non-prohibitive prescription policies in section 7. I consider two objections in sections 8 and 9: that patients ought not to make medically risky or deadly decisions, and that unrestricted access to prescription-grade pharmaceuticals would result in widespread misuse and abuse. Section 10 concludes. PMID:22844026

  7. Global Land Transport Infrastructure Requirements

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-06-01

    Over the next four decades, global passenger and freight travel is expected to double over 2010 levels. In order to accommodate this growth, it is expected that the world will need to add nearly 25 million paved road lane-kilometres and 335 000 rail track kilometres. In addition, it is expected that between 45 000 square kilometres and 77 000 square kilometres of new parking spaces will be added to accommodate vehicle stock growth. These land transport infrastructure additions, when combined with operations, maintenance and repairs, are expected to cost as much as USD 45 trillion by 2050. This publication reports on the International Energy Agency’s (IEA) analysis of infrastructure requirements to support projected road and rail travel through 2050, using the IEA Mobility Model. It considers land transport infrastructure additions to support travel growth to 2050. It also considers potential savings if countries pursue “avoid and shift” policies: in this scenario, cumulative global land transport infrastructure spending could decrease as much as USD 20 trillion by 2050 over baseline projections.

  8. The genomics of micronutrient requirements.

    Science.gov (United States)

    Monteiro, Jacqueline Pontes; Kussmann, Martin; Kaput, Jim

    2015-07-01

    Healthy nutrition is accepted as a cornerstone of public health strategies for reducing the risk of noncommunicable conditions such as obesity, cardiovascular disease, and related morbidities. However, many research studies continue to focus on single or at most a few factors that may elicit a metabolic effect. These reductionist approaches resulted in: (1) exaggerated claims for nutrition as a cure or prevention of disease; (2) the wide use of empirically based dietary regimens, as if one fits all; and (3) frequent disappointment of consumers, patients, and healthcare providers about the real impact nutrition can make on medicine and health. Multiple factors including environment, host and microbiome genetics, social context, the chemical form of the nutrient, its (bio)availability, and chemical and metabolic interactions among nutrients all interact to result in nutrient requirement and in health outcomes. Advances in laboratory methodologies, especially in analytical and separation techniques, are making the chemical dissection of foods and their availability in physiological tissues possible in an unprecedented manner. These omics technologies have opened opportunities for extending knowledge of micronutrients and of their metabolic and endocrine roles. While these technologies are crucial, more holistic approaches to the analysis of physiology and environment, novel experimental designs, and more sophisticated computational methods are needed to advance our understanding of how nutrition influences health of individuals. PMID:25981693

  9. Space systems requirements and issues

    International Nuclear Information System (INIS)

    This paper describes some of the more important space power technology issues, requirements and challenges as we enter the decade of the 1990's and provided an assessment of the impact of new component technology on the overall performance of space power systems. The paper emphasizes advanced component, subsystem and system technologies which will make a difference for the future in terms of the performance, reliability and survivability of next generation baseload and burst mode space power systems. The paper primarily addresses technology disciplines related to power sources (solar/nuclear and chemical), power conversion, energy storage, power conditioning/distribution and control and waste heat acquisition, transport and rejection. For some of these technology disciplines, performance trends are developed which can be used as the basis for projecting future, advanced power system performance. Performance capabilities for several different types of space power systems for both baseload and burst mode applications are postulated based on evolving technology and point designs which incorporate projections of advanced component capabilities

  10. 49 CFR 383.111 - Required knowledge.

    Science.gov (United States)

    2010-10-01

    ... regulations. Driver-related elements of the regulations contained in 49 CFR parts 382, 391, 392, 393, 395, 396... 49 Transportation 5 2010-10-01 2010-10-01 false Required knowledge. 383.111 Section 383.111... STANDARDS; REQUIREMENTS AND PENALTIES Required Knowledge and Skills § 383.111 Required knowledge....

  11. 48 CFR 2906.501 - Requirement.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Requirement. 2906.501... COMPETITION REQUIREMENTS Competition Advocate 2906.501 Requirement. The Assistant Secretary for Administration... be predicated on an understanding of the competition requirements in the FAR, and particularly...

  12. 48 CFR 6.501 - Requirement.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Requirement. 6.501 Section 6.501 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 6.501 Requirement. As required by section 20 of the Office...

  13. 40 CFR 240.210-1 - Requirement.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirement. 240.210-1 Section 240.210... THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.210-1 Requirement... the design requirements. An operations manual describing the various tasks to be performed,...

  14. 18 CFR 807.1 - Requirement.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Requirement. 807.1... WITHDRAWAL REGISTRATION § 807.1 Requirement. In addition to any other requirements of Commission regulations, and subject to the consent of the affected member state to this requirement, any person withdrawing...

  15. 49 CFR 383.113 - Required skills.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Required skills. 383.113 Section 383.113... STANDARDS; REQUIREMENTS AND PENALTIES Required Knowledge and Skills § 383.113 Required skills. (a) Basic vehicle control skills. All applicants for a CDL must possess and demonstrate basic motor vehicle...

  16. 21 CFR 1304.11 - Inventory requirements.

    Science.gov (United States)

    2010-04-01

    ... the inventory of the registered location to which they are subject to control or to which the person... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Inventory requirements. 1304.11 Section 1304.11... REGISTRANTS Inventory Requirements § 1304.11 Inventory requirements. (a) General requirements. Each...

  17. 40 CFR 60.4106 - Standard requirements.

    Science.gov (United States)

    2010-07-01

    ... Electric Steam Generating Units Hg Budget Trading Program General Provisions § 60.4106 Standard requirements. (a) Permit Requirements. (1) The Hg designated representative of each Hg Budget source required to have a title V operating permit and each Hg Budget unit required to have a title V...

  18. Meeting Quay 2k30's requirements

    NARCIS (Netherlands)

    Wijnants, G.H.; Toorn, A. van der; Schuylenburg, M.; Heijnen, H.P.J.; Gijt, J.G. de; Molenaar, W.F.; Ligteringen, H.; Krom, A.H.M.

    2005-01-01

    The requirements that a quay design should meet in order to yield a viable port infrastructure, vary widely from flexibility due to future customers requirements to durability due to owners requirements. In a Port of Rotterdam backed project, current and future requirements have been aggregated by c

  19. 24 CFR 1006.315 - Lease requirements.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Lease requirements. 1006.315... DEVELOPMENT NATIVE HAWAIIAN HOUSING BLOCK GRANT PROGRAM Program Requirements § 1006.315 Lease requirements... use leases that: (a) Do not contain unreasonable terms and conditions; (b) Require the DHHL, owner,...

  20. A Framework for Modelling Software Requirements

    OpenAIRE

    Dhirendra Pandey; Ugrasen Suman; A K Ramani

    2011-01-01

    Requirement engineering plays an important role in producing quality software products. In recent past years, some approaches of requirement framework have been designed to provide an end-to-end solution for system development life cycle. Textual requirements specifications are difficult to learn, design, understand, review, and maintain whereas pictorial modelling is widely recognized as an effective requirement analysis tool. In this paper, we will present a requirement modelling framework ...

  1. Requirements Engineering in Software Houses of Pakistan

    Directory of Open Access Journals (Sweden)

    Waqas Ali

    2014-09-01

    Full Text Available Requirement engineering is an essence of software development life cycle. The more time we spend on requirement engineering, higher the probability of success. Effective requirement engineering ensures and predicts successful software product. This paper presents the adaptation of requirement engineering practices in small and medium size companies of Pakistan. The study is conducted by questionnaires to show how much of requirement engineering models and practices are followed in Pakistan.

  2. 40 CFR 258.29 - Recordkeeping requirements.

    Science.gov (United States)

    2010-07-01

    ... of an approved state program may receive electronic documents only if the state program includes the requirements of 40 CFR Part 3—(Electronic reporting). ... FOR MUNICIPAL SOLID WASTE LANDFILLS Operating Criteria § 258.29 Recordkeeping requirements. (a)...

  3. Regulatory requirements for ISI qualification. Draft

    International Nuclear Information System (INIS)

    The report present drafts for the regulation documents worked out by the Committee of the Use of Atomic Energy for Peaceful Purposes. It contains the Regulatory requirements for ISI qualifications and Regulatory requirements for the Qualification Body

  4. Business System Planning Project System Requirements Specification

    Energy Technology Data Exchange (ETDEWEB)

    NELSON, R.E.

    2000-09-08

    The purpose of the Business Systems Planning Project System Requirements Specification (SRS) is to provide the outline and contents of the requirements for the CH2M HILL Hanford Group, Inc. (CHG) integrated business and technical information systems. The SRS will translate proposed objectives into the statement of the functions that are to be performed and data and information flows that they require. The requirements gathering methodology will use (1) facilitated group requirement sessions; (2) individual interviews; (3) surveys; and (4) document reviews. The requirements will be verified and validated through coordination of the technical requirement team and CHG Managers. The SRS document used the content and format specified in Lockheed Martin Services, Inc. Organization Standard Software Practices in conjunction with the Institute of Electrical and Electronics Engineers Standard 8340-1984 for Systems Requirements Documents.

  5. 8 CFR 1216.2 - Notification requirements.

    Science.gov (United States)

    2010-01-01

    ... second time of the requirement that the alien and the petitioning spouse or alien entrepreneur must file... does not relieve the alien and the petitioning spouse, or alien entrepreneur of the requirement to...

  6. 8 CFR 216.2 - Notification requirements.

    Science.gov (United States)

    2010-01-01

    ... requirement that the alien and the petitioning spouse or alien entrepreneur must file a petition to remove the... petitioning spouse, or alien entrepreneur of the requirement to file a petition to remove conditions...

  7. Physicians: Requirements for Becoming a Physician

    Science.gov (United States)

    ... Us Contact Us A | A Text size Email Requirements for Becoming a Physician Note: We are not ... the doctor's knowledge and skills remain current. CME requirements vary by state, by professional organizations, and by ...

  8. Functions and Requirements for the Transition Project

    International Nuclear Information System (INIS)

    This document describes the functional requirement baseline for the Transition of 100 K Area Facilities Project (Transition Project). This baseline information consists of top-level functions, requirements, concept description, interface description, issues, and enabling assumptions

  9. Requirements Elicitation Problems: A Literature Analysis

    Directory of Open Access Journals (Sweden)

    Bill Davey

    2015-06-01

    Full Text Available Requirements elicitation is the process through which analysts determine the software requirements of stakeholders. Requirements elicitation is seldom well done, and an inaccurate or incomplete understanding of user requirements has led to the downfall of many software projects. This paper proposes a classification of problem types that occur in requirements elicitation. The classification has been derived from a literature analysis. Papers reporting on techniques for improving requirements elicitation practice were examined for the problem the technique was designed to address. In each classification the most recent or prominent techniques for ameliorating the problems are presented. The classification allows the requirements engineer to be sensitive to problems as they arise and the educator to structure delivery of requirements elicitation training.

  10. 40 CFR 246.202-1 - Requirement.

    Science.gov (United States)

    2010-07-01

    ...-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES SOURCE SEPARATION FOR MATERIALS RECOVERY GUIDELINES Requirements and Recommended Procedures § 246.202-1 Requirement. Any commercial establishment generating 10 or more tons of waste corrugated containers per month...

  11. 40 CFR 141.500 - General requirements.

    Science.gov (United States)

    2010-07-01

    ... treatment technique requirements in lieu of maximum contaminant levels for the following contaminants: Giardia lamblia, viruses, heterotrophic plate count bacteria, Legionella, Cryptosporidium and turbidity. The treatment technique requirements consist of installing and properly operating water...

  12. Requirement Analysis: Specify the Environmental Model

    OpenAIRE

    2005-01-01

    This interactive case study illustrates the specification of the environment model in software requirements analysis using the spec language to refine and formalize the requirements in the initial problem statement. Last modified: 5/18/2009

  13. Integrating Creativity Workshops into Structured Requirements Processes

    OpenAIRE

    MAIDEN, N; Manning, S; S. Robertson; Greenwood, J.

    2004-01-01

    Requirements engineering is a creative process in which stakeholders and designers work together to create ideas for new systems that are eventually expressed as requirements. However, many requirements engineering or software development methods do not encourage or support creative thinking, let alone integrate it with existing modeling and analysis processes. This paper describes RESCUE, a scenario-driven requirements engineering process that includes workshops that integrate creativity tec...

  14. Capturing security requirements for software systems

    OpenAIRE

    Hassan El-Hadary; Sherif El-Kassas

    2014-01-01

    Security is often an afterthought during software development. Realizing security early, especially in the requirement phase, is important so that security problems can be tackled early enough before going further in the process and avoid rework. A more effective approach for security requirement engineering is needed to provide a more systematic way for eliciting adequate security requirements. This paper proposes a methodology for security requirement elicitation based on problem frames. Th...

  15. Dosimeter characteristics and service performance requirements

    International Nuclear Information System (INIS)

    The requirements for personal dosimeters and dosimetry services given by ICRP 26, ICRP 35, ICRP 60 and ICRP 75 are summarised and compared with the requirements given in relevant international standards. Most standards could be made more relevant to actual workplace conditions. In some standards, the required tests of energy and angular dependence of the response are not sufficient, or requirements on overall uncertainty are lacking. (author)

  16. Requirements Management Tools: A Quantitative Assessment

    OpenAIRE

    Sud, Rajat R.; Arthur, James D.

    2003-01-01

    This report is primarily aimed at people with some background in Requirements Engineering or practitioners wishing to assess tools available for managing requirements. We provide a starting point for this assessment, by presenting a brief survey of existing Requirements Management tools. As a part of the survey, we characterize a set of requirements management tools by outlining their features, capabilities and goals. The characterization offers a foundation to select and possibly customize a...

  17. Attributions and requirements of Islamic leadership

    OpenAIRE

    Dahlena Sari Marbun

    2013-01-01

    Purpose – The purpose of this paper is to look into the relationship between attribution and requirements of Islamic leadership. Design/methodology/approach – This paper describes concepts of attribution and requirements of leadership and links them to related Islamic concepts. Findings - A correlation is found to exist between attribution and requirements of “conventional” and Islamic leadership. Research limitations/implications - Being a practical endeavor, attribution and requirements of ...

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

    OpenAIRE

    Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Kramer, Daniel Bruce; Baker, Matthew Charles; 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 Admini...

  19. Post-marketing surveillance of anti-malarial medicines used in Malawi

    OpenAIRE

    Chikowe, Ibrahim; Osei-Safo, Dorcas; Harrison, Jerry JEK; Konadu, Daniel Y; Addae-Mensah, Ivan

    2015-01-01

    Background The growing concern over the extent of anti-malarial medicine resistance in sub-Saharan Africa, driven largely by administration of sub-therapeutic doses derived from falsified and substandard medicines necessitates regular monitoring of the quality of these medicines to avert any potential public health disaster. This study aimed at determining the active pharmaceutical ingredient (API) content of anti-malarial medicines available in Malawi with respect to the manufacturers’ label...

  20. Labour Market Structure in Malaysia: Pre- and Post-Market Gender Comparison

    Directory of Open Access Journals (Sweden)

    Chung-Khain Wye

    2012-10-01

    Full Text Available Gender inequality in Malaysian labour market can be observed through labour force participation, unemployment, occupational distribution, top management employment involving decision making, and average monthly salary. Such an inequality generally works to the disadvantage of females, notwithstanding their outperformance of educational attainment over their males’ counterparts. Case study in the ICT services subsector points to the importance of imparting employability skills among females to have its bearing on wagedetermination. As such, future research is expected to analyse gender wage decomposition taking into considerations of different types of labour market discrimination, occupational preferences, and gender differences in employability skills.

  1. 76 FR 43691 - Unique Device Identification for Postmarket Surveillance and Enforcement; Public Workshop

    Science.gov (United States)

    2011-07-21

    ... Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, Bethesda, MD 20852; 301-822-9200... workshop will be provided beginning at 11 a.m. Hotel reservations can be made by calling the hotel and... industry and some device manufacturers have been incorporating UDI into their product labeling...

  2. 78 FR 20926 - Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International...

    Science.gov (United States)

    2013-04-08

    ... accordance with ICH E2C (see 62 FR 27470 (May 19, 1997) and 69 FR 5551 (Feb. 5, 2004)) instead of a PADER...-0002, or the Office of Communication, Outreach and Development (HFM-40), Center for Biologics...-796-2380; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and...

  3. Labour Market Structure in Malaysia: Pre- and Post-Market Gender Comparison

    OpenAIRE

    Chung-Khain Wye; Rahmah Ismail

    2012-01-01

    Gender inequality in Malaysian labour market can be observed through labour force participation, unemployment, occupational distribution, top management employment involving decision making, and average monthly salary. Such an inequality generally works to the disadvantage of females, notwithstanding their outperformance of educational attainment over their males’ counterparts. Case study in the ICT services subsector points to the importance of imparting employability skills among females to...

  4. A postmarket safety comparison of 2 vaccination strategies for measles, mumps, rubella and varicella in Italy.

    Science.gov (United States)

    Cocchio, Silvia; Zanoni, Giovanna; Opri, Roberta; Russo, Francesca; Baldo, Vincenzo

    2016-03-01

    It is strategically important to monitor the safety profile of vaccination schedules in order to achieve and maintain high levels of coverage. We analyzed the cohort of individuals actively invited for measles, mumps, rubella and varicella (MMRV) vaccination in the Veneto region (north-east Italy) from 8/1/2013 to 7/31/2014, assessing the onset of adverse events (AE) relating to 2 different vaccination strategies for MMRV (MMR+V vs MMRV). During the vaccination session at 14 months old, parents were given a form for recording local and systemic reactions to vaccinations for 4 weeks afterwards. Overall, 12,288 forms were returned, and 84.6% of them were included in this analysis (5,130 relating to MMR+V and 5,265 to MMRV); 37.3% of the sample reported no AEs, with no difference between the 2 groups. Local reactions were more common in the MMR+V group (9.6% vs 2.9%; RR 3.33; 95% CI 2.79-3.98), while there was no difference in general reactions between the 2 groups (50% MMR+V vs 52% MMRV). The events most often reported were "fever perception of the AEs occurring in response to their child's vaccination. PMID:26528829

  5. 7 CFR 1724.6 - Insurance requirements.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Insurance requirements. 1724.6 Section 1724.6... Insurance requirements. (a) Borrowers shall ensure that all architects and engineers working under contract with the borrower have insurance coverage as required by part 1788 of this chapter. (b) Borrowers...

  6. 29 CFR 99.200 - Audit requirements.

    Science.gov (United States)

    2010-07-01

    ... financial statement audit of the auditee, the auditee may elect to have a program-specific audit conducted... 29 Labor 1 2010-07-01 2010-07-01 true Audit requirements. 99.200 Section 99.200 Labor Office of....200 Audit requirements. (a) Audit required. Non-Federal entities that expend $300,000 or more in...

  7. 5 CFR 1315.9 - Required documentation.

    Science.gov (United States)

    2010-01-01

    ... made electronically except in situations where the EFT requirement is waived under 31 CFR 208.4. Where... requirement is waived under 31 CFR 208.4; (ix) Contact name (where practicable), title and telephone number... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Required documentation. 1315.9...

  8. 48 CFR 1306.501 - Requirement.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Requirement. 1306.501 Section 1306.501 Federal Acquisition Regulations System DEPARTMENT OF COMMERCE COMPETITION AND ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 1306.501 Requirement. The designee authorized...

  9. 48 CFR 706.501 - Requirement.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Requirement. 706.501 Section 706.501 Federal Acquisition Regulations System AGENCY FOR INTERNATIONAL DEVELOPMENT ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 706.501 Requirement. The USAID...

  10. 48 CFR 806.501 - Requirement.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Requirement. 806.501 Section 806.501 Federal Acquisition Regulations System DEPARTMENT OF VETERANS AFFAIRS COMPETITION AND ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 806.501 Requirement. (a) The...

  11. 48 CFR 2406.501 - Requirement.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Requirement. 2406.501 Section 2406.501 Federal Acquisition Regulations System DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT COMPETITION AND ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 2406.501 Requirement....

  12. 48 CFR 3006.501 - Requirement.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Requirement. 3006.501... ACQUISITION REGULATION (HSAR) ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 3006.501 Requirement. The DHS Senior Competition Advocate (SCA) is located in the Office of the Chief...

  13. 48 CFR 2806.501 - Requirement.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Requirement. 2806.501 Section 2806.501 Federal Acquisition Regulations System DEPARTMENT OF JUSTICE Competition and Acquisition Planning COMPETITION REQUIREMENTS Competition Advocates 2806.501 Requirement. In accordance with FAR...

  14. 40 CFR 238.30 - Requirement.

    Science.gov (United States)

    2010-07-01

    ...) and 1 CFR part 51. Copies are available from the American Society of Testing and Materials, 1916 Race... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirement. 238.30 Section 238.30... CARRIERS Requirement § 238.30 Requirement. (a) No processor or person shall manufacture or import, in...

  15. 48 CFR 906.501 - Requirement.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Requirement. 906.501 Section 906.501 Federal Acquisition Regulations System DEPARTMENT OF ENERGY COMPETITION ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 906.501 Requirement. The Secretary of Energy...

  16. 48 CFR 1206.501 - Requirement.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Requirement. 1206.501 Section 1206.501 Federal Acquisition Regulations System DEPARTMENT OF TRANSPORTATION ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 1206.501 Requirement. The DOT Senior Competition Advocate...

  17. 48 CFR 1406.501 - Requirement.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Requirement. 1406.501 Section 1406.501 Federal Acquisition Regulations System DEPARTMENT OF THE INTERIOR COMPETITION AND ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 1406.501 Requirement. (a) The...

  18. 48 CFR 9903.202 - Disclosure requirements.

    Science.gov (United States)

    2010-10-01

    ... ACCOUNTING STANDARDS CONTRACT COVERAGE CAS Program Requirements 9903.202 Disclosure requirements. ... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Disclosure requirements. 9903.202 Section 9903.202 Federal Acquisition Regulations System COST ACCOUNTING STANDARDS...

  19. 76 FR 38326 - Qualification Requirements (General)

    Science.gov (United States)

    2011-06-30

    ... title 5, Code of Federal Regulations (CFR), Qualification Requirements (General). Part 338 governs... revise title 5, Code of Federal Regulations, part 338 as follows: PART 338--QUALIFICATION REQUIREMENTS...; ] OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 338 RIN 3206-AL15 Qualification Requirements (General)...

  20. 28 CFR 80.12 - Accounting requirements.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Accounting requirements. 80.12 Section 80... PROCEDURE § 80.12 Accounting requirements. Neither the submission of a request for an FCPA Opinion, its... comply with the accounting requirements of 15 U.S.C. 78m(b)(2) and (3)....

  1. 45 CFR 96.91 - Audit requirement.

    Science.gov (United States)

    2010-10-01

    ... assurance required by section 675(c)(9) of the Reconciliation Act (42 U.S.C. 9904(c)(9)) to conform to the... 45 Public Welfare 1 2010-10-01 2010-10-01 false Audit requirement. 96.91 Section 96.91 Public... Block Grants § 96.91 Audit requirement. Pursuant to section 1745(b) of the Reconciliation Act (31...

  2. 49 CFR 177.834 - General requirements.

    Science.gov (United States)

    2010-10-01

    ... the following— (i) The applicable fire suppression requirements in 29 CFR 1910.106(e), (f), (g), (h), and (i); (ii) The emergency shutdown requirements in 29 CFR 1910.119(f), 1910.120(q) and 1910.38(a); (iii) The emergency response planning requirements in 29 CFR part 1910 and 40 CFR part 68; (iv)...

  3. 16 CFR 1505.4 - Manufacturing requirements.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Manufacturing requirements. 1505.4 Section... USE BY CHILDREN Regulations § 1505.4 Manufacturing requirements. (a) General. (1) Only materials safe...-equipped manufacturing establishment. Each component of a toy shall comply with the requirements set...

  4. 78 FR 1143 - Explosive Siting Requirements; Correction

    Science.gov (United States)

    2013-01-08

    ... correcting a final rule published on September 7, 2012 (77 FR 55108). In that rule, the FAA amended its... Siting Requirements'' (77 FR 55108). In that final rule, the FAA revised the requirements for siting... Federal Aviation Administration 14 CFR Part 420 RIN 2120-AJ73 Explosive Siting Requirements;...

  5. 33 CFR 183.302 - Flotation requirements.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Flotation requirements. 183.302...) BOATING SAFETY BOATS AND ASSOCIATED EQUIPMENT Flotation Requirements for Outboard Boats Rated for Engines of 2 Horsepower or Less General § 183.302 Flotation requirements. Each boat to which this...

  6. 24 CFR 92.612 - Project requirements.

    Science.gov (United States)

    2010-04-01

    ... Development HOME INVESTMENT PARTNERSHIPS PROGRAM American Dream Downpayment Initiative § 92.612 Project requirements. The following project requirements contained in subpart F of this part apply to the ADDI: (a... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Project requirements....

  7. 29 CFR 1910.132 - General requirements.

    Science.gov (United States)

    2010-07-01

    ... proper maintenance, and sanitation of such equipment. (c) Design. All personal protective equipment shall... boots. (4) The employer is not required to pay for: (i) The logging boots required by 29 CFR 1910.266(d... OCCUPATIONAL SAFETY AND HEALTH STANDARDS Personal Protective Equipment § 1910.132 General requirements....

  8. 12 CFR 614.4255 - Independence requirements.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Independence requirements. 614.4255 Section 614... Collateral Evaluation Requirements § 614.4255 Independence requirements. (a) Prohibitions. For all personal... indirect interest, financial or otherwise, in the loan or subject property; (2) As a director, vote on...

  9. 48 CFR 806.570 - Planning requirements.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Planning requirements. 806... AND ACQUISITION PLANNING COMPETITION REQUIREMENTS Competition Advocates 806.570 Planning requirements... staff office director. (4) Ensure that the services and offices that the contracting activity...

  10. 22 CFR 126.13 - Required information.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Required information. 126.13 Section 126.13... PROVISIONS § 126.13 Required information. (a) All applications for licenses (DSP-5, DSP-61, DSP-73, and DSP... are multiple consignors, consignees or freight forwarders, and all the required information cannot...

  11. 7 CFR 277.17 - Audit requirements.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 4 2010-01-01 2010-01-01 false Audit requirements. 277.17 Section 277.17 Agriculture... FOOD STAMP AND FOOD DISTRIBUTION PROGRAM PAYMENTS OF CERTAIN ADMINISTRATIVE COSTS OF STATE AGENCIES § 277.17 Audit requirements. (a) General. This section sets forth the audit requirements for...

  12. 24 CFR 891.625 - Lease requirements.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Lease requirements. 891.625 Section 891.625 Housing and Urban Development Regulations Relating to Housing and Urban Development (Continued... Assistance § 891.625 Lease requirements. The lease requirements are provided in § 891.425....

  13. 24 CFR 891.765 - Lease requirements.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Lease requirements. 891.765 Section 891.765 Housing and Urban Development Regulations Relating to Housing and Urban Development (Continued... Individuals-Section 162 Assistance § 891.765 Lease requirements. The lease requirements are provided in §...

  14. Technical requirements for the Wismut rehabilitation project

    International Nuclear Information System (INIS)

    The technical requirements for the rehabilitation of abandoned Wismut locations are ultimately determined by the legal provisions of the various fields of law concerned. Rehabilitation requirements differ for the various objects to be rehabilitated (pits, waste heaps, settling facilities,..). This paper first presents the methodology employed for formulating recommendations for rehabilitation requirements. This is followed by a presentation of examples of rehabilitation requirements for various objects. The examples in Chapter 3 concern principal decisions made for entire locations which were made from a correspondingly general perspective. Finally the author gives examples of technical detail requirements for the rehabilitation of a waste heap

  15. Requirements management at Westinghouse Electric Company

    International Nuclear Information System (INIS)

    Field studies and surveys made in various industry branches support the Westinghouse opinion that qualitative systems engineering and requirements management have a high value in the development of complex systems and products. Two key issues causing overspending and schedule delays in projects are underestimation of complexity and misunderstandings between the different sub-project teams. These issues often arise when a project jumps too early into detail design. Good requirements management practice before detail design helps the project teams avoid such issues. Westinghouse therefore puts great effort into requirements management. The requirements management methodology at Westinghouse rests primarily on four key cornerstones: 1 - Iterative team work when developing requirements specifications, 2 - Id number tags on requirements, 3 - Robust change routine, and 4 - Requirements Traceability Matrix. (authors)

  16. A Framework for Modelling Software Requirements

    Directory of Open Access Journals (Sweden)

    Dhirendra Pandey

    2011-05-01

    Full Text Available Requirement engineering plays an important role in producing quality software products. In recent past years, some approaches of requirement framework have been designed to provide an end-to-end solution for system development life cycle. Textual requirements specifications are difficult to learn, design, understand, review, and maintain whereas pictorial modelling is widely recognized as an effective requirement analysis tool. In this paper, we will present a requirement modelling framework with the analysis of modern requirements modelling techniques. Also, we will discuss various domains of requirement engineering with the help of modelling elements such as semantic map of business concepts, lifecycles of business objects, business processes, business rules, system context diagram, use cases and their scenarios, constraints, and user interface prototypes. The proposed framework will be illustrated with the case study of inventory management system.

  17. Advanced Communications Technology: Mobile Communications Requirements Report

    Science.gov (United States)

    1998-05-01

    The Coast Guard's mobile communications requirements will outstrip existing system capabilities, available capacity, and affordability by the late 1990s. This will require changes in the mix of mobile communications equipment and services used by operational units. New commercial mobile satellite services are available now, with many others arriving on the market between 1998 and 2003. These new services present unique opportunities to satisfy mission requirements, reduce investment in communications infrastructure, and realize more costeffective communications services. The Coast Guard Research and Development Center (R&DC) has undertaken an effort to identify and evaluate current and emerging satellite services that may be used to satisfy Coast Guard mobile communications requirements. As part of this effort, Anteon Corporation has been tasked by R&DC to collect the mobile communications functional requirements that have been identified by program managers. Anteon analysts have reviewed the Government Furnished Information (GFI) and researched other related documentation to identify and collect the requirements that may be used to describe the needed operating environment. Anteon analysts assessed the functional requirements to develop system requirements that describe the features that a communications system must provide to support the functional requirements. This report presents the current and projected Coast Guard mobile communications system requirements.

  18. Management system requirements for small reactors

    International Nuclear Information System (INIS)

    This abstract identifies the management system requirements for the life cycle of small reactors from initial conception through completion of decommissioning. For small reactors, the requirements for management systems remain the same as those for 'large' reactors regardless of the licensee' business model and objectives. The CSA N-Series of standards provides an interlinked set of requirements for the management of nuclear facilities. CSA N286 provides overall direction to management to develop and implement sound management practices and controls, while other CSA nuclear standards provide technical requirements and guidance that support the management system. CSA N286 is based on a set of principles. The principles are then supported by generic requirements that are applicable to the life cycle of nuclear facilities. CNSC regulatory documents provide further technical requirements and guidance. (author)

  19. Requirements development for a patient computing system.

    OpenAIRE

    Wald, J. S.; Pedraza, L. A.; Reilly, C. A.; Murphy, M. E.; Kuperman, G. J.

    2001-01-01

    Critical parts of the software development life cycle are concerned with eliciting, understanding, and managing requirements. Though the literature on this subject dates back for several decades, practicing effective requirements development remains a current and challenging area. Some projects flourish with a requirements development process (RDP) that is implicit and informal, but this approach may be overly risky, particularly for large projects that involve multiple individuals, groups, a...

  20. Nutrient Requirements of Ruminants in Developing Countries

    OpenAIRE

    Kearl, Leonard C.

    1982-01-01

    This book was assembled using the latest information for compiling the nutrient requirements of sheep, goats, cattle and water buffalo. Because of the complexity of the interactions between an animal, its diet, its physiological state, and the environment; the values depicting the nutrient requirements are estimates and not absolutes. These values, however, are considered to be adequate to meet the minimum requirements of healthy animals maintained in a thermoneutral environment. The mean ...

  1. Requirement Defect Identification: An Early Stage Perspective

    OpenAIRE

    Md. Rizwan Beg; Sandeep Kumar Nayak; Khan, Raees A.

    2012-01-01

    Delivery of reliable software has become a primary concern for the successful software development organizations. Successful and reliable software can be delivering only when the requirement documentation is reliable. There is various threats point in the requirement phase that causes for requirement defects and so defect occurring in the further phases of Software Development process. A key aspect of delivering and improving the software reliability it is necessary to be confident that the r...

  2. Matching ERP System Functionality to Customer Requirements

    OpenAIRE

    Rolland, Colette; Prakash, Naveen

    2001-01-01

    International audience Although procuring Enterprise Resource Planning systems from commercial suppliers is becoming increasingly popular in our industry, fitting those systems to customer requirements remains problematic. In this paper, we propose an approach for matching ERP system functionality to customer requirements. The assumption made is that the ERP system postulates a set of requirements that are worth eliciting from the ERP documentation as abstractions of the ERP system functio...

  3. Model-driven Engineering for Requirements Analysis

    OpenAIRE

    Baudry, Benoit; Nebut, Clementine; Le Traon,Yves

    2007-01-01

    Requirements engineering (RE) encompasses a set of activities for eliciting, modelling, agreeing, communicating and validating requirements that precisely define the problem domain for a software system. Several tools and methods exist to perform each of these activities, but they mainly remain separate, making it difficult to capture the global consistency of large requirement documents. In this paper we introduce model-driven engineering (MDE) as a possible technical solution to integrate the...

  4. Safety assessment and the software requirements specification

    International Nuclear Information System (INIS)

    Although much work has been done on assessing safety in programmable systems, one very important aspect, the integration of hazard analysis and requirements engineering, has been somewhat neglected. The problems associated with this integration are discussed and the HAZAPS methodology is proposed as a means of solving some of these. HAZAPS was developed for identifying hazards in programmable systems, constructing and modelling safety requirements, and assessing these requirements. A computer support tool for HAZAPS is also described

  5. Agro-ecosystems water requirements for crops

    International Nuclear Information System (INIS)

    Crop water requirements were mainly influenced by meteorological factors like temperature, wind, humidity and radiational balance. In agro-ecosystems, the main water loss was through evapotranspiration. In the present article the water requirements for rice and wheat crops in India are presented. It was observed that there were strong gradients for water requirements in the north-western and south-western parts of the country

  6. Tying, Bundling, and Loyalty/Requirement Rebates

    OpenAIRE

    Nicholas Economides

    2011-01-01

    I discuss the impact of tying, bundling, and loyalty/requirement rebates on consumer surplus in the affected markets. I show that the Chicago School Theory of a single monopoly surplus that justifies tying, bundling, and loyalty/requirement rebates on the basis of efficiency typically fails. Thus, tying, bundling, and loyalty/requirement rebates can be used to extract consumer surplus and enhance profit of firms with market power. I discuss the various setups when this occurs.

  7. Safety of magnetic fusion facilities: Requirements

    International Nuclear Information System (INIS)

    This Standard identifies safety requirements for magnetic fusion facilities. Safety functions are used to define outcomes that must be achieved to ensure that exposures to radiation, hazardous materials, or other hazards are maintained within acceptable limits. Requirements applicable to magnetic fusion facilities have been derived from Federal law, policy, and other documents. In addition to specific safety requirements, broad direction is given in the form of safety principles that are to be implemented and within which safety can be achieved

  8. Requirements engineering-based conceptual modeling

    OpenAIRE

    Insfrán, E.; O. Pastor; Wieringa, R.J.

    2002-01-01

    The software production process involves a set of phases where a clear relationship and smooth transitions between them should be introduced. In this paper, a requirements engineering-based conceptual modelling approach is introduced as a way to improve the quality of the software production process. The aim of this approach is to provide a set of techniques and methods to capture software requirements and to provide a way to move from requirements to a conceptual schema in a traceable way. T...

  9. Market risk premium: Required, historical and expected

    OpenAIRE

    Fernandez, Pablo

    2004-01-01

    The market risk premium is one of the most important but elusive parameters in finance. It is also called equity premium, market premium and risk premium. The term 'market risk premium' is difficult to understand because it is used to designate three different concepts: 1) Required market risk premium, which is the incremental return of a diversified portfolio (the market) over the risk-free rate (return of treasury bonds) required by an investor. It is needed for calculating the required ret...

  10. Requirement emergence computation of networked software

    Institute of Scientific and Technical Information of China (English)

    HE Keqing; LIANG Peng; PENG Rong; LI Bing; LIU Jing

    2007-01-01

    Emergence Computation has become a hot topic in the research of complex systems in recent years.With the substantial increase in scale and complexity of network-based information systems,the uncertain user requirements from the Internet and personalized application requirement result in the frequent change for the software requirement.Meanwhile,the software system with non self-possessed,resource become more and more complex.Furthermore,the interaction and cooperation requirement between software units and running environment in service computing increase the complexity of software systems.The software systems with complex system characteristics are developing into the"Networked Software" with characteristics of change-on-demand and change-with-cooperation.The concepts "programming","compiling" and "running"of software in common sense are extended from "desktop" to "network".The core issue of software engineering is moving to the requirement engineering,which becomes the research focus of complex systemsoftware engineering.In this paper,we present the software network view based on complex system theory,and the concept of networked software and networked requirement.We proposethe challenge problem in the research of emergence computation of networked software requirement.A hierarchical & cooperative Unified requirement modeling framework URF (Unified Requirement Framework) and related RGPS (Role,Goal,Process and Service) meta-models are proposed.Five scales and the evolutionary growth mechanismin requirement emergence computation of networked software are given with focus on user-dominant and domain-oriented requirement,and the rules and predictability in requirement emergence computation are analyzed.A case study in the application of networked e-Business with evolutionary growth based on State design pattern is presented in the end.

  11. 48 CFR 23.1004 - Requirements.

    Science.gov (United States)

    2010-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Federal Compliance With Right-To-Know Laws and Pollution Prevention Requirements...

  12. 7 CFR 35.11 - Minimum requirements.

    Science.gov (United States)

    2010-01-01

    ..., Denmark, East Germany, England, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein..., Switzerland, Wales, West Germany, Yugoslavia), or Greenland shall meet each applicable minimum requirement...

  13. Space power development impact on technology requirements

    Science.gov (United States)

    Cassidy, J. F.; Fitzgerald, T. J.; Gilje, R. I.; Gordon, J. D.

    1986-01-01

    The paper is concerned with the selection of a specific spacecraft power technology and the identification of technology development to meet system requirements. Requirements which influence the selection of a given technology include the power level required, whether the load is constant or transient in nature, and in the case of transient loads, the time required to recover the power, and overall system safety. Various power technologies, such as solar voltaic power, solar dynamic power, nuclear power systems, and electrochemical energy storage, are briefly described.

  14. Using SCR methods to analyze requirements documentation

    Science.gov (United States)

    Callahan, John; Morrison, Jeffery

    1995-01-01

    Software Cost Reduction (SCR) methods are being utilized to analyze and verify selected parts of NASA's EOS-DIS Core System (ECS) requirements documentation. SCR is being used as a spot-inspection tool. Through this formal and systematic approach of the SCR requirements methods, insights as to whether the requirements are internally inconsistent or incomplete as the scenarios of intended usage evolve in the OC (Operations Concept) documentation. Thus, by modelling the scenarios and requirements as mode charts using the SCR methods, we have been able to identify problems within and between the documents.

  15. SE Requirements Development Tool User Guide

    Energy Technology Data Exchange (ETDEWEB)

    Benson, Faith Ann [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-05-13

    The LANL Systems Engineering Requirements Development Tool (SERDT) is a data collection tool created in InfoPath for use with the Los Alamos National Laboratory’s (LANL) SharePoint sites. Projects can fail if a clear definition of the final product requirements is not performed. For projects to be successful requirements must be defined early in the project and those requirements must be tracked during execution of the project to ensure the goals of the project are met. Therefore, the focus of this tool is requirements definition. The content of this form is based on International Council on Systems Engineering (INCOSE) and Department of Defense (DoD) process standards and allows for single or collaborative input. The “Scoping” section is where project information is entered by the project team prior to requirements development, and includes definitions and examples to assist the user in completing the forms. The data entered will be used to define the requirements and once the form is filled out, a “Requirements List” is automatically generated and a Word document is created and saved to a SharePoint document library. SharePoint also includes the ability to download the requirements data defined in the InfoPath from into an Excel spreadsheet. This User Guide will assist you in navigating through the data entry process.

  16. Site Evaluation for Nuclear Installations. Safety Requirements

    International Nuclear Information System (INIS)

    This publication establishes requirements and provides criteria for ensuring safety in site evaluation for nuclear installations. The Safety Guides on site evaluation listed in the references section provide recommendations on how to meet the requirements established in this publication. A review of Safety Requirements publications was commenced in 2011 following the accident in the Fukushima Daiichi nuclear power plant in Japan. The review revealed no significant areas of weakness and resulted in just a small set of amendments to strengthen the requirements and facilitate their implementation, which are contained in the present publication

  17. Nursing staff requirements for neonatal intensive care.

    OpenAIRE

    Williams, S.; Whelan, A; Weindling, A M; Cooke, R W

    1993-01-01

    A study to estimate the number of nursing staff required for neonatal nursing was undertaken. Certain nursing tasks, such as transporting any infant, caring for the dying infant, and looking after the very unstable infant required continuous attention by one nurse (5.5 whole time equivalent (wte) nurses for each cot). The stable ventilated infant required 10.5 nursing hours each day-that is, 2.4 wte/cot. Infants with intravenous infusions, but not ventilated, required only slightly less nursi...

  18. 45 CFR 1080.8 - Reporting requirements.

    Science.gov (United States)

    2010-10-01

    ... violence. (Information collection requirements are approved by the Office of Management and Budget under..., ADMINISTRATION FOR CHILDREN AND FAMILIES, DEPARTMENT OF HEALTH AND HUMAN SERVICES EMERGENCY COMMUNITY...

  19. A Requirements Analysis Model Based on QFD

    Institute of Scientific and Technical Information of China (English)

    TANG Zhi-wei; Nelson K.H.Tang

    2004-01-01

    The enterprise resource planning (ERP) system has emerged to offer an integrated IT solution and more and more enterprises are increasing by adopting this system and regarding it as an important innovation. However, there is already evidence of high failure risks in ERP project implementation, one major reason is poor analysis of the requirements for system implementation. In this paper, the importance of requirements analysis for ERP project implementation is highlighted, and a requirements analysis model by applying quality function deployment (QFD) is presented, which will support to conduct requirements analysis for ERP project.

  20. Universal Sensor and Actuator Requirements. Chapter 5

    Science.gov (United States)

    Rosenfeld, Taylor; Webster, John; Garg, Sanjay

    2009-01-01

    The previous chapters have focused on the requirements for sensors and actuators for "More Intelligent Gas Turbine Engines" from the perspective of performance and operating environment. Even if a technology is available, which meets these performance requirements, there are still various hurdles to be overcome for the technology to transition into a real engine. Such requirements relate to TRL (Technology Readiness Level), durability, reliability, volume, weight, cost, etc. This chapter provides an overview of such universal requirements which any sensor or actuator technology will have to meet before it can be implemented on a product. The objective here is to help educate the researchers or technology developers on the extensive process that the technology has to go through beyond just meeting performance requirements. The hope is that such knowledge will help the technology developers as well as decision makers to prevent wasteful investment in developing solutions to performance requirements, which have no potential to meet the "universal" requirements. These "universal" requirements can be divided into 2 broad areas: 1) Technology value proposition; and 2) Technology maturation. These requirements are briefly discussed in the following.

  1. Maintainability program requirements for space systems

    Science.gov (United States)

    1987-01-01

    This document is established to provide common general requirements for all NASA programs to: design maintainability into all systems where maintenance is a factor in system operation and mission success; and ensure that maintainability characteristics are developed through the systems engineering process. These requirements are not new. Design for ease of maintenance and minimization of repair time have always been fundamental requirements of the systems engineering process. However, new or reusable orbital manned and in-flight maintainable unmanned space systems demand special emphasis on maintainability, and this document has been prepared to meet that need. Maintainability requirements on many NASA programs differ in phasing and task emphasis from requirements promulgated by other Government agencies. This difference is due to the research and development nature of NASA programs where quantities produced are generally small; therefore, the depth of logistics support typical of many programs is generally not warranted. The cost of excessive maintenance is very high due to the logistics problems associated with the space environment. The ability to provide timely maintenance often involves safety considerations for manned space flight applications. This document represents a basic set of requirements that will achieve a design for maintenance. These requirements are directed primarily at manned and unmanned orbital space systems. To be effective, maintainability requirements should be tailored to meet specific NASA program and project needs and constraints. NASA activities shall invoke the requirements of this document consistent with program planning in procurements or on inhouse development efforts.

  2. Bandwidth requirements for fine resolution squinted SAR

    Energy Technology Data Exchange (ETDEWEB)

    DOERRY,ARMIN W.

    2000-03-01

    The conventional rule-of-thumb for Synthetic Aperture Radar is that an RF bandwidth of c/(2{rho}{sub r}) is required to image a scene at the desired slant-range resolution {rho}{sub r}, and perhaps a little more to account for window functions and sidelobe control. This formulation is based on the notion that the total bandwidth required is the same bandwidth that is required for a single pulse. What is neglected is that efficient processing of an entire synthetic aperture of pulses will often require different frequency content for each of the different pulses that makeup a synthetic aperture. Consequently, the total RF bandwidth required of a Synthetic Aperture Radar may then be substantially wider than the bandwidth of any single pulse. The actual RF bandwidth required depends strongly on flight geometry, owing to the desire for a radar to maintain a constant projection of the Fourier space collection surface onto the {omega}{sub y} axis. Long apertures required for fine azimuth resolution, and severe squint angles with steep depression angles may require total RF bandwidths well beyond the minimum bandwidth required of any single transmitted pulse, perhaps even by a factor of two or more. Accounting for this is crucial to designing efficient versatile high-performance imaging radars. This paper addresses how a data set conducive to efficient processing might increase the total RF bandwidth, and presents examples of how a fixed RF bandwidth might then limit SAR geometries.

  3. Exploratory Study to Assess and Evaluate Requirement Specification Techniques Using Analysis Determination Requirements Framework

    OpenAIRE

    Souhaib Besrour; Lukman Bin Ab Rahim; P.D.D.Dominic

    2015-01-01

    Various requirements engineering techniques have been proposed to enhance the quality of requirement as well as the implemented software and to growth customer satisfaction with the product. However the large number of requirement techniques makes the choosing between them complicated and confusing. Consequently, this study purposes to present an exploratory study to evaluate requirement techniques and illuminate their key features, limitations and strength.

  4. CH2M Hill Hanford Group, Inc., Standards and Requirements Identification Document (SRID) Requirements Management System and Requirements Specification

    International Nuclear Information System (INIS)

    The current Tank Farm Contractor (TFC) for the U. S. Department of Energy, Office of River Protection (ORP), River Protection Project (RPP), CH2M Hill Hanford Group, Inc. (CHG), will use a computer based requirements management system. The system will serve as a tool to assist in identifying, capturing, and maintaining the Standards/Requirements Identification Document (S/RID) requirements and links to implementing procedures and other documents. By managing requirements as one integrated set, CHG will be able to carry out its mission more efficiently and effectively. CHG has chosen the Dynamic Object Oriented Requirements System (DOORS(trademark)) as the preferred computer based requirements management system. Accordingly, the S/RID program will use DOORS(trademark). DOORS(trademark) will replace the Environmental Requirements Management Interface (ERMI) system as the tool for S/RID data management. The DOORS(trademark) S/RID test project currently resides on the DOORSTM test server. The S/RID project will be migrated to the DOORS(trademark) production server. After the migration the S/RID project will be considered a production project and will no longer reside on the test server

  5. 21 CFR 660.2 - General requirements.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false General requirements. 660.2 Section 660.2 Food and... ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.2 General requirements. (a) Processing. The processing method shall be one that has been shown...

  6. 49 CFR 377.103 - Tariff requirements.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Tariff requirements. 377.103 Section 377.103... CHARGES Handling of C.O.D. Shipments § 377.103 Tariff requirements. No common carrier of property subject....d. service unless such carrier has published, posted and filed tariffs which contain the...

  7. Passive ALWR requirements to prevent containment failure

    International Nuclear Information System (INIS)

    The purpose of this report is to document a systematic evaluation of the Passive Advanced Light Water Reactor (ALWR) design requirements which address severe accident mitigation. This evaluation was performed concurrent with completion of the ALWR Requirements Document to assure the adequacy of these mitigation requirements. The passive plant approach to containment integrity assurance reflects an expansion of the approach established earlier for evolutionary ALWRs. The report identifies containment challenges that might occur coincident with or result from a core damage event, compiles the set of passive ALWR design requirements which addresses each challenge, and evaluates each set of requirements on an integrated basis to confirm that the requirements provide substantial assurance that coincident core damage and containment failure are precluded. Based on past PRAs, a review of pertinent safety functions, severe accident analyses, current regulatory requirements, and reviews by ALWR design personnel, twenty-three (23) potential containment challenges were identified. The report concludes that the relevant ALWR requirements severe to limit the likelihood and magnitude of the challenges, and to assure the capability of the containment to accommodate all challenges which remain potentially risk-significant

  8. 32 CFR 766.9 - Insurance requirements.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Insurance requirements. 766.9 Section 766.9... DEPARTMENT OF THE NAVY AVIATION FACILITIES BY CIVIL AIRCRAFT § 766.9 Insurance requirements. (a) Control of insurance. The Commander, Naval Facilities Engineering Command, or his designee, shall be responsible...

  9. 15 CFR 911.8 - Technical requirements.

    Science.gov (United States)

    2010-01-01

    ... PROCEDURES CONCERNING USE OF THE NOAA SPACE-BASED DATA COLLECTION SYSTEMS § 911.8 Technical requirements. (a) All platform operators of the NOAA DCS must use a data collection platform radio set whose technical... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Technical requirements. 911.8...

  10. 50 CFR 660.15 - Equipment requirements.

    Science.gov (United States)

    2010-10-01

    ... receivers, computer hardware for electronic fish ticket software and computer hardware for electronic... provided by Pacific States Marine Fish Commission are required to meet the hardware and software... not subject to any specific hardware or software requirements. (1) Hardware and software...

  11. 46 CFR 153.238 - Required materials.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 5 2010-10-01 2010-10-01 false Required materials. 153.238 Section 153.238 Shipping... BULK LIQUID, LIQUEFIED GAS, OR COMPRESSED GAS HAZARDOUS MATERIALS Design and Equipment Cargo Containment Systems § 153.238 Required materials. When one of the following paragraphs of this section...

  12. 7 CFR 1290.10 - Audit requirements.

    Science.gov (United States)

    2010-01-01

    ... PROGRAM § 1290.10 Audit requirements. The State is accountable for conducting a financial audit of the... 7 Agriculture 10 2010-01-01 2010-01-01 false Audit requirements. 1290.10 Section 1290.10... audit, a copy of the audit results....

  13. Protein requirements for long term missions

    Science.gov (United States)

    Stein, T. P.

    1994-01-01

    A key component of the diet for a space mission is protein. This first part of this paper reviews the reasons for emphasizing protein nurtition and then discusses what the requirements are likely to be. The second part discusses potential advantages of modifying these requirements and describes potential potential approaches to effecting these modificatons based on well established ground based models.

  14. 40 CFR 240.203-1 - Requirement.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirement. 240.203-1 Section 240.203-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.203-1...

  15. 40 CFR 240.206-1 - Requirement.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirement. 240.206-1 Section 240.206-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.206-1...

  16. 40 CFR 240.209-1 - Requirement.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirement. 240.209-1 Section 240.209-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.209-1...

  17. 40 CFR 240.205-1 - Requirement.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirement. 240.205-1 Section 240.205-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.205-1...

  18. 40 CFR 240.207-1 - Requirement.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirement. 240.207-1 Section 240.207-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.207-1...

  19. 40 CFR 240.200-1 - Requirement.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirement. 240.200-1 Section 240.200-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.200-1...

  20. 40 CFR 240.202-1 - Requirement.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirement. 240.202-1 Section 240.202-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.202-1...

  1. Core Requirements for the Economics Major

    Science.gov (United States)

    Petkus, Marie; Perry, John J.; Johnson, Bruce K.

    2014-01-01

    In this article, the authors are the first to describe the core economics curriculum requirements for economics majors at all American colleges and universities, as opposed to a sample of institutions. Not surprisingly, principles of economics is nearly universally required and implemented as a two-semester course in 85 percent of economics major…

  2. 40 CFR 240.201-1 - Requirement.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirement. 240.201-1 Section 240.201-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.201-1...

  3. 40 CFR 240.204-1 - Requirement.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirement. 240.204-1 Section 240.204-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.204-1...

  4. 40 CFR 240.208-1 - Requirement.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirement. 240.208-1 Section 240.208-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.208-1...

  5. Canister Storage Building (CSB) Technical Safety Requirements

    International Nuclear Information System (INIS)

    The purpose of this section is to explain the meaning of logical connectors with specific examples. Logical connectors are used in Technical Safety Requirements (TSRs) to discriminate between, and yet connect, discrete Conditions, Required Actions, Completion Times, Surveillances, and Frequencies. The only logical connectors that appear in TSRs are AND and OR. The physical arrangement of these connectors constitutes logical conventions with specific meanings

  6. 49 CFR 232.203 - Training requirements.

    Science.gov (United States)

    2010-10-01

    ... EQUIPMENT; END-OF-TRAIN DEVICES Inspection and Testing Requirements § 232.203 Training requirements. (a... refresher training, at an interval not to exceed three years, that includes classroom and “hands-on... to be equipped with a two-way end-of-train telemetry device pursuant to subpart E of this part,...

  7. Requirements for transporting the TMI-2 core

    International Nuclear Information System (INIS)

    This report summarizes the requirements associated with the actual transport of core debris from the damaged Three Mile Island Unit 2 reactor to the Idaho National Engineering Laboratory. The requirements are discussed under six headings: accountability, security, quality, safety, environment, and transportation

  8. 40 CFR 211.210 - Requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirements. 211.210 Section 211.210 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS PRODUCT NOISE LABELING Hearing Protective Devices § 211.210 Requirements....

  9. 40 CFR 205.157 - Requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirements. 205.157 Section 205.157 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS TRANSPORTATION EQUIPMENT NOISE EMISSION CONTROLS Motorcycles § 205.157 Requirements....

  10. 24 CFR 221.501 - Eligibility requirements.

    Science.gov (United States)

    2010-04-01

    ... LOW COST AND MODERATE INCOME MORTGAGE INSURANCE-SAVINGS CLAUSE Eligibility Requirements-Moderate... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Eligibility requirements. 221.501 Section 221.501 Housing and Urban Development Regulations Relating to Housing and Urban...

  11. 14 CFR 21.613 - Recordkeeping requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Recordkeeping requirements. 21.613 Section 21.613 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT... requirements. (a) Keeping the records. Each manufacturer holding a TSO authorization under this part shall,...

  12. 32 CFR 235.7 - Information requirements.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 2 2010-07-01 2010-07-01 false Information requirements. 235.7 Section 235.7 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS SALE OR RENTAL OF SEXUALLY EXPLICIT MATERIAL ON DOD PROPERTY § 235.7 Information requirements....

  13. 45 CFR 98.70 - Reporting requirements.

    Science.gov (United States)

    2010-10-01

    ... (April 1998 through June 1998). States and Territorial Lead Agencies which choose to submit case-level... Program Reporting Requirements § 98.70 Reporting requirements. (a) Quarterly Case-level Report— (1) State and territorial Lead Agencies that receive assistance under the CCDF shall prepare and submit to...

  14. 21 CFR 211.180 - General requirements.

    Science.gov (United States)

    2010-04-01

    ... General requirements. (a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain...

  15. Oxygen requirement and tolerance of Campylobacter jejuni.

    Science.gov (United States)

    The human pathogen Campylobacter jejuni is considered a microaerophile, yet it has been shown to grow in vitro under atmospheres with elevated oxygen tensions. Hence, a better understanding of the oxygen requirement and tolerance of C. jejuni is required. Bacterial growth was measured under various ...

  16. Legal requirements governing proxy voting in Denmark

    DEFF Research Database (Denmark)

    Werlauff, Erik

    2008-01-01

    The requirements in Danish company law concerning proxy voting in companies whose shares have been accepted for listing on a regulated market have been successively tightened in recent years, and corporate governance principles have also led to the introduction of several requirements concerning...

  17. 16 CFR 307.5 - Language requirements.

    Science.gov (United States)

    2010-01-01

    ... case of an advertisement for a smokeless tobacco product in a newspaper, magazine, periodical, or other... requirements. The warning statement on the label of a smokeless tobacco product required by the Act and these regulations shall be set out in the English language. If the label of a smokeless tobacco product contains...

  18. 10 CFR 904.5 - Revenue requirements.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Revenue requirements. 904.5 Section 904.5 Energy... PROJECT Power Marketing § 904.5 Revenue requirements. (a) Western shall collect all electric service revenues from the Project in accordance with applicable statutes and regulations and deposit such...

  19. 8 CFR 312.1 - Literacy requirements.

    Science.gov (United States)

    2010-01-01

    ... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Literacy requirements. 312.1 Section 312.1... FOR NATURALIZATION § 312.1 Literacy requirements. (a) General. Except as otherwise provided in... unable, because of a medically determinable physical or mental impairment or combination of...

  20. 13 CFR 307.5 - Application requirements.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Application requirements. 307.5 Section 307.5 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE... EDA) a CEDS, except that a CEDS is not required when applying for a Strategy Grant; and (2)...

  1. 49 CFR 630.4 - Requirements.

    Science.gov (United States)

    2010-10-01

    ... from the National Transit Database Web site located at http://www.ntdprogram.gov. These reference... Transit Database Web site and a notice of any significant changes to the reporting requirements specified... TRANSPORTATION NATIONAL TRANSIT DATABASE § 630.4 Requirements. (a) National Transit Database Reporting...

  2. 10 CFR 36.39 - Design requirements.

    Science.gov (United States)

    2010-01-01

    ... REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Design and Performance... lost for more than 10 seconds. (j) Seismic. For panoramic irradiators to be built in seismic areas, the... an earthquake by designing to the seismic requirements of an appropriate source such as...

  3. 7 CFR 1944.672 - Environmental requirements.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 13 2010-01-01 2009-01-01 true Environmental requirements. 1944.672 Section 1944.672 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... following is additional information on how to approach HPG projects under those requirements: (a)...

  4. 40 CFR 141.131 - Analytical requirements.

    Science.gov (United States)

    2010-07-01

    ... 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be inspected at EPA's Drinking Water Docket, 1301... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Analytical requirements. 141.131... Disinfection Byproduct Precursors § 141.131 Analytical requirements. (a) General. (1) Systems must use only...

  5. 46 CFR 177.700 - General requirements.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false General requirements. 177.700 Section 177.700 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) SMALL PASSENGER VESSELS (UNDER 100 GROSS TONS) CONSTRUCTION AND ARRANGEMENT Crew Spaces § 177.700 General requirements. (a) A crew accommodation space and...

  6. 46 CFR 177.100 - General requirement.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false General requirement. 177.100 Section 177.100 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) SMALL PASSENGER VESSELS (UNDER 100 GROSS TONS) CONSTRUCTION AND ARRANGEMENT General Provisions § 177.100 General requirement. The construction and...

  7. 46 CFR 177.800 - General requirements.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false General requirements. 177.800 Section 177.800 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) SMALL PASSENGER VESSELS (UNDER 100 GROSS TONS) CONSTRUCTION AND ARRANGEMENT Passenger Accommodations § 177.800 General requirements. (a) All...

  8. 20 CFR 220.133 - Skill requirements.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false Skill requirements. 220.133 Section 220.133... DISABILITY Vocational Considerations § 220.133 Skill requirements. (a) General. To evaluate skills and to... claimant does not gain work skills by doing unskilled jobs. For example, jobs are considered unskilled...

  9. 20 CFR 404.1568 - Skill requirements.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Skill requirements. 404.1568 Section 404.1568...- ) Determining Disability and Blindness Vocational Considerations § 404.1568 Skill requirements. In order to evaluate your skills and to help determine the existence in the national economy of work you are able to...

  10. 14 CFR 65.59 - Skill requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Skill requirements. 65.59 Section 65.59 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN CERTIFICATION: AIRMEN OTHER THAN FLIGHT CREWMEMBERS Aircraft Dispatchers § 65.59 Skill requirements....

  11. 14 CFR 63.57 - Skill requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Skill requirements. 63.57 Section 63.57 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN CERTIFICATION: FLIGHT CREWMEMBERS OTHER THAN PILOTS Flight Navigators § 63.57 Skill requirements. (a)...

  12. 14 CFR 65.79 - Skill requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Skill requirements. 65.79 Section 65.79... CERTIFICATION: AIRMEN OTHER THAN FLIGHT CREWMEMBERS Mechanics § 65.79 Skill requirements. Each applicant for a... cover the applicant's basic skill in performing practical projects on the subjects covered by...

  13. 20 CFR 416.968 - Skill requirements.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Skill requirements. 416.968 Section 416.968... DISABLED Determining Disability and Blindness Vocational Considerations § 416.968 Skill requirements. In order to evaluate your skills and to help determine the existence in the national economy of work...

  14. 14 CFR 63.39 - Skill requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Skill requirements. 63.39 Section 63.39 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN CERTIFICATION: FLIGHT CREWMEMBERS OTHER THAN PILOTS Flight Engineers § 63.39 Skill requirements. (a)...

  15. 29 CFR 4231.5 - Valuation requirement.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Valuation requirement. 4231.5 Section 4231.5 Labor... PLANS § 4231.5 Valuation requirement. (a) In general. For a plan that is not a significantly affected... has terminated by mass withdrawal under section 4041A(a)(2) of ERISA, the actuarial...

  16. Herausforderungen fuer das Requirements Engineering eingebetteter Systeme

    OpenAIRE

    Andreas Fleischmann; Eva Geisberger; Markus Pister

    2016-01-01

    Abstract: In diesem Bericht werden in kompakter Form die spezifischen Problemstellungen und Herausforderungen bei der Entwicklung Eingebetteter Systeme aufgezeigt und die entsprechenden Anforderungen an das Requirements Engineering definiert. Der Bericht ist Teilergebnis des REFOCUS Projekts am Lehrstuhl von Professor Broy, in dem eine durchgehende Methodik fuer das Requirements Engineering Eingebetteter Systeme entworfen wird.

  17. 27 CFR 5.33 - Additional requirements.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Additional requirements. 5.33 Section 5.33 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF DISTILLED SPIRITS Labeling Requirements...

  18. 27 CFR 4.38 - General requirements.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false General requirements. 4.38 Section 4.38 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine §...

  19. 44 CFR 80.21 - Closeout requirements.

    Science.gov (United States)

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Closeout requirements. 80.21 Section 80.21 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF... restriction language to meet the requirements of this part; (b) A photo of each property site after...

  20. Monitored Retrievable Storage System Requirements Document

    International Nuclear Information System (INIS)

    This Monitored Retrievable Storage System Requirements Document (MRS-SRD) describes the functions to be performed and technical requirements for a Monitored Retrievable Storage (MRS) facility subelement and the On-Site Transfer and Storage (OSTS) subelement. The MRS facility subelement provides for temporary storage, at a Civilian Radioactive Waste Management System (CRWMS) operated site, of spent nuclear fuel (SNF) contained in an NRC-approved Multi-Purpose Canister (MPC) storage mode, or other NRC-approved storage modes. The OSTS subelement provides for transfer and storage, at Purchaser sites, of spent nuclear fuel (SNF) contained in MPCs. Both the MRS facility subelement and the OSTS subelement are in support of the CRWMS. The purpose of the MRS-SRD is to define the top-level requirements for the development of the MRS facility and the OSTS. These requirements include design, operation, and decommissioning requirements to the extent they impact on the physical development of the MRS facility and the OSTS. The document also presents an overall description of the MRS facility and the OSTS, their functions (derived by extending the functional analysis documented by the Physical System Requirements (PSR) Store Waste Document), their segments, and the requirements allocated to the segments. In addition, the top-level interface requirements of the MRS facility and the OSTS are included. As such, the MRS-SRD provides the technical baseline for the MRS Safety Analysis Report (SAR) design and the OSTS Safety Analysis Report design

  1. 17 CFR 41.45 - Required margin.

    Science.gov (United States)

    2010-04-01

    ... PRODUCTS Customer Accounts and Margin Requirements § 41.45 Required margin. (a) Applicability. Each... positions held on behalf of a customer in a securities account or futures account as set forth in this... security future shall be twenty (20) percent of the current market value of such security future....

  2. 17 CFR 242.403 - Required margin.

    Science.gov (United States)

    2010-04-01

    ...) REGULATIONS M, SHO, ATS, AC, AND NMS AND CUSTOMER MARGIN REQUIREMENTS FOR SECURITY FUTURES Customer Margin... of a customer in a securities account or futures account as set forth in this section. (b) Required... be twenty (20) percent of the current market value of such security future. (2) Offsetting...

  3. 8 CFR 245.4 - Documentary requirements.

    Science.gov (United States)

    2010-01-01

    ... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Documentary requirements. 245.4 Section 245.4 Aliens and Nationality DEPARTMENT OF HOMELAND SECURITY IMMIGRATION REGULATIONS ADJUSTMENT OF STATUS TO THAT OF PERSON ADMITTED FOR PERMANENT RESIDENCE § 245.4 Documentary requirements....

  4. 38 CFR 21.3102 - Required counseling.

    Science.gov (United States)

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Required counseling. 21.... Chapter 35 Counseling § 21.3102 Required counseling. (a) Child. The VA counseling psychologist will provide counseling and assist in preparing the educational plan only if the eligible child or his or...

  5. Linoleic acid intake and vitamin E requirement

    NARCIS (Netherlands)

    Jager, F.C.

    1973-01-01

    In experiments with rats and Peking ducklings it has been investigated to what extent the linoleic acid content of the diet is of influence on the requirement of vitamin E. This requirement was determined by adding D-α-tocopheryl acetate in increasing doses to vitamin E-free diets and to determine h

  6. 40 CFR 425.06 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Monitoring requirements. 425.06 Section 425.06 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS LEATHER TANNING AND FINISHING POINT SOURCE CATEGORY General Provisions § 425.06 Monitoring requirements. Compliance with monthly...

  7. 32 CFR 162.7 - Information requirements.

    Science.gov (United States)

    2010-07-01

    ... ENHANCING CAPITAL INVESTMENT (PECI) § 162.7 Information requirements. (a) DoD Components shall submit to the ASD (FM&P), by December 15th of each year, an annual status report on all PECI programs as outlined in... requirements. (b) The Summary Report, “PECI Program Status,” is assigned Report Control Symbol FM&P (A)...

  8. 14 CFR 258.5 - Notice requirement.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Notice requirement. 258.5 Section 258.5 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF TRANSPORTATION (AVIATION PROCEEDINGS) ECONOMIC... are shown as requiring a change of aircraft. (b) Oral notice to prospective consumers. In any...

  9. 40 CFR 141.70 - General requirements.

    Science.gov (United States)

    2010-07-01

    ... regulations establish criteria under which filtration is required as a treatment technique for public water... under the direct influence of surface water. In addition, these regulations establish treatment technique requirements in lieu of maximum contaminant levels for the following contaminants: Giardia...

  10. 37 CFR 2.51 - Drawing required.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Drawing required. 2.51... COMMERCE RULES OF PRACTICE IN TRADEMARK CASES Drawing § 2.51 Drawing required. (a) In an application under section 1(a) of the Act, the drawing of the mark must be a substantially exact representation of the...

  11. 27 CFR 24.196 - Formula required.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Formula required. 24.196... OF THE TREASURY LIQUORS WINE Production of Special Natural Wine § 24.196 Formula required. Before producing any special natural wine, the proprietor shall receive approval of the formula by which it is...

  12. 27 CFR 24.201 - Formula required.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Formula required. 24.201... OF THE TREASURY LIQUORS WINE Production of Agricultural Wine § 24.201 Formula required. Before producing any agricultural wine, the proprietor shall obtain an approval of the formula and process by...

  13. 27 CFR 24.211 - Formula required.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Formula required. 24.211... OF THE TREASURY LIQUORS WINE Production of Other Than Standard Wine § 24.211 Formula required. The proprietor who desires to produce wine other than standard wine shall first obtain approval of the formula...

  14. 27 CFR 19.378 - Formula requirements.

    Science.gov (United States)

    2010-04-01

    ... Manufacture of Articles Formulas § 19.378 Formula requirements. An approved formula on TTB Form 5110.38 must be secured for spirits for domestic use or export as provided in 27 CFR 5.26-5.27 before processors... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Formula requirements....

  15. 42 CFR 3.106 - Security requirements.

    Science.gov (United States)

    2010-10-01

    ... ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT PSO Requirements and Agency Procedures § 3.106 Security requirements. (a) Application. A PSO must secure patient safety work product in conformance with the security... the confidentiality and security of patient safety work product. (2) Distinguishing patient...

  16. General Education Requirements: A Comparative Analysis

    Science.gov (United States)

    Warner, Darrell B.; Koeppel, Katie

    2009-01-01

    While "general education" is a phrase heavily used in higher education, Leskes and Wright note that it has multiple meanings: it can refer to those courses that a college or university requires all of its students must pass as a condition for graduation, a common curriculum, a distribution requirement, or even core texts. This analysis of general…

  17. Requirements Analysis for Information-Intensive Systems

    Science.gov (United States)

    Callender, E. D.; Hartsough, C.; Morris, R. V.; Yamamoto, Y.

    1986-01-01

    Report discusses role of requirements analysis in development of information-intensive systems. System examined from variety of human viewpoints during design, development, and implementation. Such examination, called requirements analysis, ensures system simultaneously meets number of distinct but interacting needs. Viewpoints defined and integrated to help attain objectives.

  18. 7 CFR 1770.13 - Accounting requirements.

    Science.gov (United States)

    2010-01-01

    ... statements shall be prepared for the period and audited in accordance with the provisions of 7 CFR part 1773... 7 Agriculture 12 2010-01-01 2010-01-01 false Accounting requirements. 1770.13 Section 1770.13... AGRICULTURE (CONTINUED) ACCOUNTING REQUIREMENTS FOR RUS TELECOMMUNICATIONS BORROWERS Uniform System...

  19. 40 CFR 205.55 - Requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirements. 205.55 Section 205.55 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS TRANSPORTATION EQUIPMENT NOISE EMISSION CONTROLS Medium and Heavy Trucks § 205.55 Requirements....

  20. 40 CFR 63.775 - Reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... requirements specified in 40 CFR 61.247, except that the Periodic Reports shall be submitted on the schedule... 40 Protection of Environment 10 2010-07-01 2010-07-01 false Reporting requirements. 63.775 Section 63.775 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS...

  1. 49 CFR 451.25 - Required information.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 6 2010-10-01 2010-10-01 false Required information. 451.25 Section 451.25....25 Required information. (a) The safety approval number appearing on line 1 of the safety approval... safety approval plate on the freight container provided that all the information contained on...

  2. 19 CFR 142.6 - Invoice requirements.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 2 2010-04-01 2010-04-01 false Invoice requirements. 142.6 Section 142.6 Customs... (CONTINUED) ENTRY PROCESS Entry Documentation § 142.6 Invoice requirements. (a) Contents. The commercial invoice, or the documentation acceptable in place of a commercial invoice in those instances listed...

  3. 7 CFR 58.810 - Temperature requirements.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Temperature requirements. 58.810 Section 58.810... Procedures § 58.810 Temperature requirements. (a) Unless processed within 2 hours, all whey or condensed whey... be cooled to 45 °F or less, or heated to 145 °F or higher. Other temperatures may be used...

  4. 7 CFR 1423.5 - Application requirements.

    Science.gov (United States)

    2010-01-01

    ... WAREHOUSES § 1423.5 Application requirements. To apply for approval under this part, a warehouse operator... storage agreement; (b) Evidence of compliance with § 1423.4; (c) Current financial information sufficient to meet the requirements of § 1423.6; (d) For State licensed or non-licensed warehouse operators,...

  5. 49 CFR 130.21 - Packaging requirements.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Packaging requirements. 130.21 Section 130.21 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY... Packaging requirements. Each packaging used for the transportation of oil subject to this part must...

  6. 12 CFR 704.15 - Audit requirements.

    Science.gov (United States)

    2010-01-01

    ... UNIONS § 704.15 Audit requirements. (a) External audit. The corporate credit union supervisory committee... supervisory committee shall submit the audit report to the board of directors. A copy of the audit report, and... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Audit requirements. 704.15 Section 704.15...

  7. 12 CFR 989.2 - Audit requirements.

    Science.gov (United States)

    2010-01-01

    ... the audit committee of each Bank, the OF board of directors, and the Financing Corporation Directorate... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Audit requirements. 989.2 Section 989.2 Banks... Audit requirements. (a) Each Bank, the OF and the Financing Corporation shall obtain annually...

  8. 7 CFR 3560.156 - Lease requirements.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Lease requirements. 3560.156 Section 3560.156... AGRICULTURE DIRECT MULTI-FAMILY HOUSING LOANS AND GRANTS Multi-Family Housing Occupancy § 3560.156 Lease requirements. (a) Agency approval. Borrowers must use a lease approved by the Agency. The lease must...

  9. 24 CFR 886.127 - Lease requirements.

    Science.gov (United States)

    2010-04-01

    ... the tenancy for “other good cause” under 24 CFR 247.3(a)(3), unless the termination is based on family... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Lease requirements. 886.127 Section... for Projects With HUD-Insured and HUD-Held Mortgages § 886.127 Lease requirements. (a) Term of...

  10. 24 CFR 884.215 - Lease requirements.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Lease requirements. 884.215 Section... RENTAL HOUSING PROJECTS Project Development and Operation § 884.215 Lease requirements. The Lease shall... provisions listed in paragraph (c) of this section. (a) Term of lease. The term of the Lease shall be for...

  11. 24 CFR 891.425 - Lease requirements.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Lease requirements. 891.425 Section... Lease requirements. This section shall apply to capital advances under the Section 202 Program and the Section 811 Program, as well as loans financed under subpart E of this part. (a) Term of lease. The...

  12. 24 CFR 886.327 - Lease requirements.

    Science.gov (United States)

    2010-04-01

    ... tenancy for “other good cause” under 24 CFR 247.3(a)(3), unless the termination is based on family... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Lease requirements. 886.327 Section... Program for the Disposition of HUD-Owned Projects § 886.327 Lease requirements. (a) Term of lease. (1)...

  13. 5 CFR 842.704 - Election requirements.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Election requirements. 842.704 Section... Election requirements. (a) The election of an alternative form of annuity and evidence of spousal consent... certify that the current spouse presented identification, gave consent to the specific election...

  14. 32 CFR 505.9 - Reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Reporting requirements. 505.9 Section 505.9 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY AID OF CIVIL AUTHORITIES AND PUBLIC RELATIONS ARMY PRIVACY ACT PROGRAM § 505.9 Reporting requirements. The Department of the Army...

  15. Cervical cancer vaccine: Exploring new opportunities and challenges for developing countries

    Directory of Open Access Journals (Sweden)

    Ananya Ray Laskar

    2011-01-01

    Full Text Available Cervical cancer is the second most common cancer in women worldwide, and the burden of the disease is disproportionately high in the developing world (>80%. With the advent of two new vaccines, "Gardasil" developed by Merck & Co. New Jersey, USA and "Cervarix" developed by GlaxoSmithKline (GSK in Philadelphia, USA, the future holds newer promises for prevention and control of the disease. However, various regulatory and policy changes also may be required to be undertaken and the various new challenges need to be addressed.

  16. Software requirements specification for critical applications

    International Nuclear Information System (INIS)

    The software requirements specification document is a central document for any engineered software product but is of crucial importance for critical applications for the following reasons: it is used as a basis of review of the required functionality of the system being specified; it is the basis of the software design; it is used as a basis for review of the design; and it is used as a basis of the testing of the final product. Adequate assurance that a software product has met its requirements cannot be attained without a complete, precise, unambiguous, and correct specification of the required behavior of the software based system. This paper presents a technique for requirements specification, based on a finite state machine model and tabular representation of mathematical functions, which is being developed at Ontario Hydro for use during development of software for use in real-time, critical applications

  17. Nonfunctional requirements in systems analysis and design

    CERN Document Server

    Adams, Kevin MacG

    2015-01-01

    This book will help readers gain a solid understanding of non-functional requirements inherent in systems design endeavors. It contains essential information for those who design, use, and maintain complex engineered systems, including experienced designers, teachers of design, system stakeholders, and practicing engineers. Coverage approaches non-functional requirements in a novel way by presenting a framework of four systems concerns into which the 27 major non-functional requirements fall: sustainment, design, adaptation, and viability. Within this model, the text proceeds to define each non-functional requirement, to specify how each is treated as an element of the system design process, and to develop an associated metric for their evaluation. Systems are designed to meet specific functional needs. Because non-functional requirements are not directly related to tasks that satisfy these proposed needs, designers and stakeholders often fail to recognize the importance of such attributes as availability, su...

  18. Instrumentation requirements for the ESF thermomechanical experiments

    Energy Technology Data Exchange (ETDEWEB)

    Pott, J. [Sandia National Labs., Albuquerque, NM (United States); Brechtel, C.E. [Agapito (J.F.T.) and Associates, Inc., Grand Junction, CO (United States)

    1992-12-31

    In situ thermomechanical experiments are planned as part of the Yucca Mountain Site Characterization Project that require instruments to measure stress and displacement at temperatures that exceed the typical specifications of existing geotechnical instruments. A high degree of instrument reliability will also be required to satisfy the objectives of the experiments, therefore a study was undertaken to identify areas where improvement in instrument performance was required. A preliminary list of instruments required for the experiments was developed, based on existing test planning and analysis. Projected temperature requirements were compared to specifications of existing instruments to identify instrumentation development needs. Different instrument technologies, not currently employed in geotechnical instrumentation, were reviewed to identify potential improvements of existing designs for the high temperature environment. Technologies with strong potentials to improve instrument performance with relatively high reliability include graphite fiber composite materials, fiber optics, and video imagery.

  19. Instrumentation requirements for the ESF thermomechanical experiments

    International Nuclear Information System (INIS)

    In situ thermomechanical experiments are planned as part of the Yucca Mountain Site Characterization Project that require instruments to measure stress and displacement at temperatures that exceed the typical specifications of existing geotechnical instruments. A high degree of instrument reliability will also be required to satisfy the objectives of the experiments, therefore a study was undertaken to identify areas where improvement in instrument performance was required. A preliminary list of instruments required for the experiments was developed, based on existing test planning and analysis. Projected temperature requirements were compared to specifications of existing instruments to identify instrumentation development needs. Different instrument technologies, not currently employed in geotechnical instrumentation, were reviewed to identify potential improvements of existing designs for the high temperature environment. Technologies with strong potentials to improve instrument performance with relatively high reliability include graphite fiber composite materials, fiber optics, and video imagery

  20. ATLAS Future Framework Requirements Group Report

    CERN Document Server

    The ATLAS collaboration

    2016-01-01

    The Future Frameworks Requirements Group was constituted in Summer 2013 to consider and summarise the framework requirements from trigger and offline for configuring, scheduling and monitoring the data processing software needed by the ATLAS experiment. The principal motivation for such a re-examination arises from the current and anticipated evolution of CPUs, where multiple cores, hyper-threading and wide vector registers require a shift to a concurrent programming model. Such a model requires extensive changes in the current Gaudi/Athena frameworks and offers the opportunity to consider how HLT and offline processing can be better accommodated within the ATLAS framework. This note contains the report of the Future Frameworks Requirements Group.

  1. Crewed Space Vehicle Battery Safety Requirements

    Science.gov (United States)

    Jeevarajan, Judith A.; Darcy, Eric C.

    2014-01-01

    This requirements document is applicable to all batteries on crewed spacecraft, including vehicle, payload, and crew equipment batteries. It defines the specific provisions required to design a battery that is safe for ground personnel and crew members to handle and/or operate during all applicable phases of crewed missions, safe for use in the enclosed environment of a crewed space vehicle, and safe for use in launch vehicles, as well as in unpressurized spaces adjacent to the habitable portion of a space vehicle. The required provisions encompass hazard controls, design evaluation, and verification. The extent of the hazard controls and verification required depends on the applicability and credibility of the hazard to the specific battery design and applicable missions under review. Evaluation of the design and verification program results shall be completed prior to certification for flight and ground operations. This requirements document is geared toward the designers of battery systems to be used in crewed vehicles, crew equipment, crew suits, or batteries to be used in crewed vehicle systems and payloads (or experiments). This requirements document also applies to ground handling and testing of flight batteries. Specific design and verification requirements for a battery are dependent upon the battery chemistry, capacity, complexity, charging, environment, and application. The variety of battery chemistries available, combined with the variety of battery-powered applications, results in each battery application having specific, unique requirements pertinent to the specific battery application. However, there are basic requirements for all battery designs and applications, which are listed in section 4. Section 5 includes a description of hazards and controls and also includes requirements.

  2. A MODEL FOR ALIGNING SOFTWARE PROJECTS REQUIREMENTS WITH PROJECT TEAM MEMBERS REQUIREMENTS

    Directory of Open Access Journals (Sweden)

    Robert Hans

    2013-02-01

    Full Text Available The fast-paced, dynamic environment within which information and communication technology (ICT projects are run as well as ICT professionals’ constant changing requirements present a challenge for project managers in terms of aligning projects’ requirements with project team members’ requirements. This research paper purports that if projects’ requirements are properly aligned with team members’ requirements, then this will result in a balanced decision approach. Moreover, such an alignment will result in the realization of employee’s needs as well as meeting project’s needs. This paper presents a Project’s requirements and project Team members’ requirements (PrTr alignment model and argues that a balanced decision which meets both software project’s requirements and team members’ requirements can be achieved through the application of the PrTr alignment model.

  3. Mined Geologic Disposal System Requirements Document

    International Nuclear Information System (INIS)

    This Mined Geologic Disposal System Requirements Document (MGDS-RD) describes the functions to be performed by, and the requirements for, a Mined Geologic Disposal System (MGDS) for the permanent disposal of spent nuclear fuel (SNF) (including SNF loaded in multi-purpose canisters (MPCs)) and commercial and defense high-level radioactive waste (HLW) in support of the Civilian Radioactive Waste Management System (CRWMS). The purpose of the MGDS-RD is to define the program-level requirements for the design of the Repository, the Exploratory Studies Facility (ESF), and Surface Based Testing Facilities (SBTF). These requirements include design, operation, and decommissioning requirements to the extent they impact on the physical development of the MGDS. The document also presents an overall description of the MGDS, its functions (derived using the functional analysis documented by the Physical System Requirements (PSR) documents as a starting point), its segments as described in Section 3.1.3, and the requirements allocated to the segments. In addition, the program-level interfaces of the MGDS are identified. As such, the MGDS-RD provides the technical baseline for the design of the MGDS

  4. Identifying dependability requirements for space software systems

    Directory of Open Access Journals (Sweden)

    Edgar Toshiro Yano

    2010-09-01

    Full Text Available Computer systems are increasingly used in space, whether in launch vehicles, satellites, ground support and payload systems. Software applications used in these systems have become more complex, mainly due to the high number of features to be met, thus contributing to a greater probability of hazards related to software faults. Therefore, it is fundamental that the specification activity of requirements have a decisive role in the effort of obtaining systems with high quality and safety standards. In critical systems like the embedded software of the Brazilian Satellite Launcher, ambiguity, non-completeness, and lack of good requirements can cause serious accidents with economic, material and human losses. One way to assure quality with safety, reliability and other dependability attributes may be the use of safety analysis techniques during the initial phases of the project in order to identify the most adequate dependability requirements to minimize possible fault or failure occurrences during the subsequent phases. This paper presents a structured software dependability requirements analysis process that uses system software requirement specifications and traditional safety analysis techniques. The main goal of the process is to help to identify a set of essential software dependability requirements which can be added to the software requirement previously specified for the system. The final results are more complete, consistent, and reliable specifications.

  5. TWRS configuration management requirement source document

    International Nuclear Information System (INIS)

    The TWRS Configuration Management (CM) Requirement Source document prescribes CM as a basic product life-cycle function by which work and activities are conducted or accomplished. This document serves as the requirements basis for the TWRS CM program. The objective of the TWRS CM program is to establish consistency among requirements, physical/functional configuration, information, and documentation for TWRS and TWRS products, and to maintain this consistency throughout the life-cycle of TWRS and the product, particularly as changes are being made

  6. Security Requirements for One Stop Government

    Science.gov (United States)

    Schäfer, Georg E.

    The highest ranking e-government solutions are based on one-window, one-click or one stop government concepts. For Europe, the EU services directive sets new requirements for e-government, that have to be met till December 2009. Simple, easy to understand and complete information is one requirement. The other requirements are, that the services covered by this directive shall be available electronically and at a distance (which means mostly “by Internet”). Acceptable solutions are digitally signed mails and, as an alternative or supplement, transaction oriented online services. To implement this, a one stop government with document safe is best practice.

  7. Smart gun technology requirements preliminary report

    Energy Technology Data Exchange (ETDEWEB)

    Weiss, D.R.; Brandt, D.J.; Tweet, K.D.

    1995-05-01

    Goal of the Smart Gun Technology project is to eliminate the capability of an unauthorized user from firing a law enforcement officer`s firearm by implementing user-recognizing-and-authorizing surety technologies. This project is funded by the National Institute of Justice. This document reports the projects first objective: to find and document the requirements for a user-recognizing-and-authorizing firearm technology that law enforcement officers will value. This report details the problem of firearm takeaways in law enforcement, the methodology used to develop the law enforcement officers` requirements, and the requirements themselves.

  8. Nuclear data requirements for fusion reactor shielding

    International Nuclear Information System (INIS)

    The nuclear data requirements for experimental, demonstration and commercial fusion reactors are reviewed. Particular emphasis is given to the shield as well as major reactor components of concern to the nuclear performance. The nuclear data requirements are defined as a result of analyzing four key areas. These are the most likely candidate materials, energy range, types of needed nuclear data, and the required accuracy in the data. Deducing the latter from the target goals for the accuracy in prediction is also discussed. A specific proposal of measurements is recommended. Priorities for acquisition of data are also assigned. (author)

  9. Quality Assurance Source Requirements Traceability Database

    International Nuclear Information System (INIS)

    At the Yucca Mountain Project the Project Requirements Processing System assists in the management of relationships between regulatory and national/industry standards source criteria, and Quality Assurance Requirements and Description document (DOE/R W-0333P) requirements to create compliance matrices representing respective relationships. The matrices are submitted to the U.S. Nuclear Regulatory Commission to assist in the commission's review, interpretation, and concurrence with the Yucca Mountain Project QA program document. The tool is highly customized to meet the needs of the Office of Civilian Radioactive Waste Management Office of Quality Assurance

  10. Cold vacuum drying facility design requirements

    Energy Technology Data Exchange (ETDEWEB)

    Irwin, J.J.

    1997-09-24

    This release of the Design Requirements Document is a complete restructuring and rewrite to the document previously prepared and released for project W-441 to record the design basis for the design of the Cold Vacuum Drying Facility.

  11. 8 CFR 234.2 - Landing requirements.

    Science.gov (United States)

    2010-01-01

    ... permission from an immigration officer. (d) Emergency or forced landing. Should any aircraft carrying... emergency or forced landing. ... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Landing requirements. 234.2 Section...

  12. 46 CFR 310.6 - Entrance requirements.

    Science.gov (United States)

    2010-10-01

    ... requirements, will be acceptable to the Administration. (5) Possess a secondary school education or equivalent... qualities of leadership. (b) Enrollment on or after April 1, 1982. A candidate for admission to a school...

  13. Understand the Design Requirement in Companies

    DEFF Research Database (Denmark)

    Li, Xuemeng; Ahmed-Kristensen, Saeema

    2015-01-01

    Often product development processes, in the market-pull cases, start with identifying the needs or problems that the product is expected to satisfy or solve. The initial needs and problems should be formulated into abstract, unambiguous, traceable and validatable design requirements (Brace...... and Cheutet, 2012). Design requirements coordinate the diverse desires in the end product and provide the basis of synthesizing a solution (Darlington and Culley, 2004). Various studies have been conducted in the engineering design field both descriptively to comprehend the design requirement practice......, and prescriptively to improve practice through developing theories and methods etc. (Darlington and Culley, 2002). Several procedures for developing design requirements have been proposed in literatures e.g. (Dieter and Schmidt, 2007; Pahl, et Al., 2007; Ulrich and Eppinger, 2011). Poorly identified design...

  14. The European utility requirements for future ALWRs

    International Nuclear Information System (INIS)

    The EUR (European Utilities Requirements) effort was launched in December 1991 by five European utilities, later rejoined by four others. The objective was to write down common requirements for light water reactors of the next generation, which would be built in the near future. Benefits from this approach are expected in the fields of plant licensing, public acceptance as well as the strengthening of nuclear energy competitiveness. These requirements address both evolutive reactors and the ones using intensively passive safety devices, PWRs as well as BWRs. A number of new features appear in these requirements, like the concept of Design Extension Conditions, which is developed to cover the severe accident issue, and a new classification system for all structures, systems, and components. Emphasis is put on standardisation and simplification, but also on margins and cost objectives. (orig./GL)

  15. Some Findings Concerning Requirements in Agile Methodologies

    Science.gov (United States)

    Rodríguez, Pilar; Yagüe, Agustín; Alarcón, Pedro P.; Garbajosa, Juan

    Agile methods have appeared as an attractive alternative to conventional methodologies. These methods try to reduce the time to market and, indirectly, the cost of the product through flexible development and deep customer involvement. The processes related to requirements have been extensively studied in literature, in most cases in the frame of conventional methods. However, conclusions of conventional methodologies could not be necessarily valid for Agile; in some issues, conventional and Agile processes are radically different. As recent surveys report, inadequate project requirements is one of the most conflictive issues in agile approaches and better understanding about this is needed. This paper describes some findings concerning requirements activities in a project developed under an agile methodology. The project intended to evolve an existing product and, therefore, some background information was available. The major difficulties encountered were related to non-functional needs and management of requirements dependencies.

  16. Cold vacuum drying facility design requirements

    International Nuclear Information System (INIS)

    This release of the Design Requirements Document is a complete restructuring and rewrite to the document previously prepared and released for project W-441 to record the design basis for the design of the Cold Vacuum Drying Facility

  17. 38 CFR 36.4365 - Appraisal requirements.

    Science.gov (United States)

    2010-07-01

    ... substantially completed except for customer preference items, such as interior finishes, appliances or equipment... units in the project. Lenders shall certify as to satisfaction of the presale requirement prior to...

  18. 14 CFR 61.183 - Eligibility requirements.

    Science.gov (United States)

    2010-01-01

    ... Flight Instructors With a Sport Pilot Rating § 61.183 Eligibility requirements. To be eligible for a... university. (f) Pass a knowledge test on the aeronautical knowledge areas listed in § 61.185(a)(2) and...

  19. 24 CFR 234.26 - Project requirements.

    Science.gov (United States)

    2010-04-01

    ... meet this occupancy requirement. (f) Limitations on conversion of rental housing to condominium use... entity (the same individual, investor group, partnership, or corporation) may own more than 10 percent...

  20. 32 CFR 505.8 - Training requirements.

    Science.gov (United States)

    2010-07-01

    ... PUBLIC RELATIONS ARMY PRIVACY ACT PROGRAM § 505.8 Training requirements. (a) Training. (1) The Privacy... specialists, finance officers, DOD personnel who may be expected to deal with the news media or the...

  1. Target input requirements for heavy ion fusion

    International Nuclear Information System (INIS)

    This paper summarizes the requirements a heavy ion accelerator must meet in order to initiate practical thermonuclear microexplosions. Particular emphasis is given to the question of maximum allowable ion energy

  2. Technical parameters for specifying imagery requirements

    Science.gov (United States)

    Coan, Paul P.; Dunnette, Sheri J.

    1994-01-01

    Providing visual information acquired from remote events to various operators, researchers, and practitioners has become progressively more important as the application of special skills in alien or hazardous situations increases. To provide an understanding of the technical parameters required to specify imagery, we have identified, defined, and discussed seven salient characteristics of images: spatial resolution, linearity, luminance resolution, spectral discrimination, temporal discrimination, edge definition, and signal-to-noise ratio. We then describe a generalizing imaging system and identified how various parts of the system affect the image data. To emphasize the different applications of imagery, we have constrasted the common television system with the significant parameters of a televisual imaging system for technical applications. Finally, we have established a method by which the required visual information can be specified by describing certain technical parameters which are directly related to the information content of the imagery. This method requires the user to complete a form listing all pertinent data requirements for the imagery.

  3. Requirements Engineering In Current Web Engineering Methodologies

    Directory of Open Access Journals (Sweden)

    R. Jeyakarthik

    2011-05-01

    Full Text Available Web engineering – the discipline concerned with the development of quality web applications has been receiving a lot of attention in the recent era with the increasing number of web projects being undertaken by many organizations. Many methodologies have been proposed in this regard. Requirements engineering – being an integral and crucial phase in traditional software engineering, also necessitates a careful consideration in web engineering as well. The present paper presents an overview of how well the available web engineering methodologies address requirements engineering. The types of requirements, techniques, activities and the level of detail supported by the web engineering methodologies available today are tabulated and this throws light on the need for new methodologies that address requirements engineering in a greater depth for web applications.

  4. Space shuttle requirements/configuration evolution

    Science.gov (United States)

    Andrews, E. P.

    1991-01-01

    Space Shuttle chronology; Space Shuttle comparison; Cost comparison; Performance; Program ground rules; Sizing criteria; Crew/passenger provisions; Space Shuttle Main Engine (SSME) characteristics; Space Shuttle program milestones; and Space Shuttle requirements are outlined. This presentation is represented by viewgraphs.

  5. 16 CFR 432.2 - Required disclosures.

    Science.gov (United States)

    2010-01-01

    ... UTILIZED IN HOME ENTERTAINMENT PRODUCTS § 432.2 Required disclosures. (a) Whenever any direct or indirect... sound power amplification equipment in any product brochure or manufacturer specification sheet,...

  6. Radiation safety requirements for radionuclide laboratories

    International Nuclear Information System (INIS)

    The guide lays down the requirements for laboratories and storage rooms in which radioactive substances are used or stored as unsealed sources. In addition, some general instructions concerning work in radionuclide laboratories are set out

  7. 75 FR 12803 - Fingerprint Submission Requirements Rule

    Science.gov (United States)

    2010-03-17

    ...Notice of the Compact Council's establishment of a process for initiating noncriminal justice criminal history record checks during times of emergencies and disasters under the authority of the Fingerprint Submission Requirements Rule, title 28 Code of Federal Regulations (CFR), part...

  8. 40 CFR 141.170 - General requirements.

    Science.gov (United States)

    2010-07-01

    ... regulations in this subpart establish or extend treatment technique requirements in lieu of maximum contaminant levels for the following contaminants: Giardia lamblia, viruses, heterotrophic plate count... must provide treatment of its source water that complies with these treatment technique...

  9. 48 CFR 750.7108 - Contractual requirements.

    Science.gov (United States)

    2010-10-01

    ... CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS Extraordinary Contractual Actions To Protect Foreign Policy Interests of the United States 750.7108 Contractual requirements. Every contract amended or... policy interests of the United States....

  10. Radiation safety requirements for radionuclide laboratories

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-07-01

    The guide lays down the requirements for laboratories and storage rooms in which radioactive substances are used or stored as unsealed sources. In addition, some general instructions concerning work in radionuclide laboratories are set out.

  11. Change in requirements during the design process

    DEFF Research Database (Denmark)

    Sudin, Mohd Nizam Bin; Ahmed-Kristensen, Saeema

    on a pre-defined coding scheme. The results of the study shows that change in requirements were initiated by internal stakeholders through analysis and evaluation activities during the design process, meanwhile external stakeholders were requested changes during the meeting with consultant. All......Specification is an integral part of the product development process. Frequently, more than a single version of a specification is produced due to changes in requirements. These changes are often necessary to ensure the scope of the design problem is as clear as possible. However, the negative...... effects of such changes include an increase in lead-time and cost. Thus, support to mitigate change in requirements is essential. A thorough understanding of the nature of changes in requirements is essential before a method or tool to mitigate these changes can be proposed. Therefore, a case study...

  12. Adapting safety requirements analysis to intrusion detection

    Science.gov (United States)

    Lutz, R.

    2001-01-01

    Several requirements analysis techniques widely used in safety-critical systems are being adapted to support the analysis of secure systems. Perhaps the most relevant system safety techique for Intrusion Detection Systems is hazard analysis.

  13. Metals Production Requirements for Rapid Photovoltaics Deployment

    CERN Document Server

    Kavlak, Goksin; Jaffe, Robert L; Trancik, Jessika E

    2015-01-01

    If global photovoltaics (PV) deployment grows rapidly, the required input materials need to be supplied at an increasing rate. In this paper, we quantify the effect of PV deployment levels on the scale of metals production. For example, we find that if cadmium telluride {copper indium gallium diselenide} PV accounts for more than 3% {10%} of electricity generation by 2030, the required growth rates for the production of indium and tellurium would exceed historically-observed production growth rates for a large set of metals. In contrast, even if crystalline silicon PV supplies all electricity in 2030, the required silicon production growth rate would fall within the historical range. More generally, this paper highlights possible constraints to the rate of scaling up metals production for some PV technologies, and outlines an approach to assessing projected metals growth requirements against an ensemble of past growth rates from across the metals production sector. The framework developed in this paper may be...

  14. 48 CFR 22.602 - Statutory requirements.

    Science.gov (United States)

    2010-10-01

    ... required by the Act pertaining to such matters as minimum wages, maximum hours, child labor, convict labor... PROGRAMS APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS Walsh-Healey Public Contracts Act...

  15. Should Universities lower Admission Requirements for Celebrities?

    Institute of Scientific and Technical Information of China (English)

    2012-01-01

    In recent years, many famous universities lower admission requirements for celebrities. More and more celebrities, especially sports stars, have been admitted to famous universities even without an entry examination. This phenomenon has become a subject of widespread controversy.

  16. Requirements for gamma radiation survey meter calibration

    International Nuclear Information System (INIS)

    This guide describes the minimum requirements for calibrating a portable analog gamma radiation survey meter by means of a beam calibrator, with a known calibration source. If an alternative method of calibration is to be used the licensee should make a written request to the Atomic Energy Control Board that describes the calibration method to be used, and request the Board's permission to use that method in place of the requirements contained in this guide. This guide explains: the responsibility for survey meter calibration if licensees calibrate their own survey meters, use the services of a Canadian calibration agency, and use the services of a non-Canadian calibration agency; the requirements for survey meter calibration and the supporting documentation; the requirements for record-keeping; and, a calibration certificate, a calibration sticker, and a notification of failure to calibrate form, with examples

  17. 32 CFR 516.61 - Reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... PUBLIC RELATIONS LITIGATION Remedies in Procurement Fraud and Corruption § 516.61 Reporting requirements... is requested by PFD, the provisions of DFARS 209.406-3 (48 CFR 209.406-3) will be followed....

  18. Projected uranium requirements of developing countries

    International Nuclear Information System (INIS)

    The objective of this paper is to examine the uranium requirements of developing countries both in aggregate and individually. Although the cumulative uranium requirements of these countries are expected to account for less than eight percent of total requirements, the fact that many of these countries are expressing renewed interest in nuclear is, in itself, encouraging. The countries analyzed in this paper are Argentina, Brazil, Egypt, India, Israel, Mexico, Pakistan, South Africa, South Korea and Taiwan. For each country, the existing and planned nuclear capacity levels have been identified and capacity factors have been projected. For countries with no previous nuclear power, the world weighted average capacity factor for the specific reactor type is utilized. Other factors influencing nuclear power demand and operations of these developing countries will be discussed, and finally, uranium requirements based on a calculated optimal tails assay of .30 will be provided

  19. Gas Test Loop Functional and Technical Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Glen R. Longhurst; Soli T. Khericha; James L. Jones

    2004-09-01

    This document defines the technical and functional requirements for a gas test loop (GTL) to be constructed for the purpose of providing a high intensity fast-flux irradiation environment for developers of advanced concept nuclear reactors. This capability is needed to meet fuels and materials testing requirements of the designers of Generation IV (GEN IV) reactors and other programs within the purview of the Advanced Fuel Cycle Initiative (AFCI). Space nuclear power development programs may also benefit by the services the GTL will offer. The overall GTL technical objective is to provide developers with the means for investigating and qualifying fuels and materials needed for advanced reactor concepts. The testing environment includes a fast-flux neutron spectrum of sufficient intensity to perform accelerated irradiation testing. Appropriate irradiation temperature, gaseous environment, test volume, diagnostics, and access and handling features are also needed. This document serves to identify those requirements as well as generic requirements applicable to any system of this kind.

  20. Determination of Basic Household Water Requirements (Revised)

    OpenAIRE

    Inocencio, Arlene B.; Padilla, Jose E.; Javier, Esmyra P.

    1999-01-01

    The concern for determining the basic or minimum water requirement for a person to maintain good health and proper sanitation comes about in the light of the current state of water resources and the growing scarcity against a rapidly rising population. This paper’s contribution is the determination of this basic or minimum water requirement which is necessary to sustain human life and other basic human activities through a record keeping approach and use of an econometric tool. Specifically, ...