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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. Postmarketing safety reports for human drug and biological products; electronic submission requirements. Final rule.

    Science.gov (United States)

    2014-06-10

    The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.

  4. 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® ...

  5. Postmarketing surveillance for drug abuse.

    Science.gov (United States)

    Arfken, Cynthia L; Cicero, Theodore J

    2003-06-01

    Assessing actual abuse of prescribed medications requires postmarketing surveillance. In this article we discuss general systems of postmarketing surveillance that exist as of the end of 2002 in the United States and two medication-specific surveillance systems that were devised and tested. The two specific surveillance systems are compared with limitations highlighted. Postmarketing surveillance is in its infancy and requires more research on ways to improve its validity without inducing illicit experimentation. Information on comparator medications is highly recommended both to validate the system and to place the results in context.

  6. 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...

  7. [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.

  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. 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

  10. 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. |

  11. Monitoring product safety in the postmarketing environment.

    Science.gov (United States)

    Sharrar, Robert G; Dieck, Gretchen S

    2013-10-01

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

  12. 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

    .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......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....... Immunogenicity was evaluated for up to 12 months. Neutralizing anti-HPV-16/18 antibodies were measured by pseudovirion-based neutralization assay (PBNA). Laboratory tests and diary cards were used for safety assessment. The HPV-DNA status of the participants was determined before and after immunization...

  13. Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

    Directory of Open Access Journals (Sweden)

    A. Anil Sinaci

    2015-01-01

    Full Text Available Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases.

  14. 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

  15. Postmarketing surveillance of abuse liability of sibutramine.

    Science.gov (United States)

    Arfken, Cynthia L; Schuster, Charles R; Johanson, Chris-Ellyn

    2003-03-01

    The abuse liability of medications is a growing concern as the number of newly approved psychoactive medications increases. Postmarketing surveillance can assist in determining abuse liability, but strategies are not well-defined for medications believed to be at low abuse risk. Using a newly approved medication (sibutramine--an anorectic drug), a novel approach to postmarketing abuse surveillance was introduced. A one-page anonymous questionnaire covering sibutramine, a scheduled anorectic drug (phentermine), and a fabricated name was added to the intake process of 58 treatment programs. From the 8780 completed questionnaires, 8.8% had heard of sibutramine and phentermine. For continued use to get high (a proxy for abuse), the rate for sibutramine was lower than for phentermine (0.6 vs. 2.2%, McNemar's chi(2) = 110.45, P < 0.001) but was higher than for the fabricated name (0.6 vs. 0.3%, McNemar's chi(2) = 11.86, P < 0.001). These results suggest the risk of abuse associated with sibutramine was lower than that associated with a known abused drug, one that itself is considered low risk despite decades of population exposure. The relatively high rate of hearing of sibutramine may be due to the direct-to-consumer advertisement. This approach is only one indicator in a surveillance framework but appears promising and validates findings from laboratory-based abuse liability studies that also indicate low abuse liability for sibutramine.

  16. 21 CFR 314.81 - Other postmarketing reports.

    Science.gov (United States)

    2010-04-01

    ... generic drug ceased being distributed, and the corresponding trade or brand name. Each dosage form and/or... constitute an unwarranted invasion of personal privacy. (viii) Status of other postmarketing studies....

  17. 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 ...

  18. 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

  19. Postmarketing drug surveillance by record linkage in Tayside.

    Science.gov (United States)

    Crombie, I K; Brown, S V; Hamley, J G

    1984-09-01

    The feasibility of conducting postmarketing drug surveillance by record linkage in Tayside was assessed. The key feature of the method is that all hospital discharge data are already computerised by the area health board and may be accessed through the unique community health number (CHNo) which has been allocated to all Tayside residents. The 12 861 prescriptions for cimetidine dispensed in Tayside over a nine month period were collected and the CHNo identified for 76%. These corresponded to 3802 individuals and their discharge data, together with those for an equal number of controls matched by age, sex, and general practitioner were retrieved from the computer. The expected excess of those diseases for which cimetidine is prescribed (peptic ulcer and oesophagitis) was observed. Other drug-disease associations were observed but may have been due to confounding and emphasise the inadequacy of community based controls. The major advantages of record linkage are, firstly, the low cost of the method, the present study costing just over pounds 12 000, and, secondly, the duration of patient follow up which may may be extended for as many years as required simply by rerunning the computer programs. To assemble large patient cohorts the study would have to be extended to other area health boards that are currently developing similar computer systems. Record linkage may provide a cost effective method for the follow up of patients to identify serious adverse drug reactions, particularly those that take several years to develop.

  20. 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... postmarket surveillance, clinical studies, and evidence appraisal. DATES: The public workshop will be held...

  1. 21 CFR 822.8 - When, where, and how must I submit my postmarket surveillance plan?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false When, where, and how must I submit my postmarket surveillance plan? 822.8 Section 822.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance Plan §...

  2. 21 CFR 822.15 - How long must I conduct postmarket surveillance of my device?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false How long must I conduct postmarket surveillance of my device? 822.15 Section 822.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Postmarket Surveillance...

  3. Patients' motives for participating in active post-marketing surveillance

    NARCIS (Netherlands)

    Harmark, Linda; Lie-Kwie, Miguel; Berm, Lisette; de Gier, Han; van Grootheest, Kees

    2013-01-01

    Purpose Web-based intensive monitoring is a method to actively collect information about adverse drug reactions (ADRs) using patients as a source of information. To date, little is known about patients' motivation to participate in this kind of active post-marketing surveillance (PMS). Increased ins

  4. 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

  5. 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

  6. 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。

  7. 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...

  8. 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...

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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...

  14. 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

    (®) (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......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......-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...

  15. 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

  16. 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...

  17. 21 CFR 822.11 - What should I consider when designing my plan to conduct postmarket surveillance?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What should I consider when designing my plan to conduct postmarket surveillance? 822.11 Section 822.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE...

  18. 21 CFR 822.12 - Do you have any information that will help me prepare my submission or design my postmarket...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Do you have any information that will help me prepare my submission or design my postmarket surveillance plan? 822.12 Section 822.12 Food and Drugs FOOD... POSTMARKET SURVEILLANCE Postmarket Surveillance Plan § 822.12 Do you have any information that will help...

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

    DEFF Research Database (Denmark)

    Tetens, Inge

    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 0.5 mg/kg bw/day....

  20. [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

  1. 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...

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

    Science.gov (United States)

    Ezaki, Asami; Hori, Akiko

    2013-03-01

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

  3. 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.

  4. [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

  5. 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

  6. 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 ...

  7. 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...

  8. 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

  9. 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

  10. [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

  11. 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

  12. 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.

  13. 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

  14. 75 FR 68802 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements...

    Science.gov (United States)

    2010-11-09

    .... FDA's Implementing Regulations On October 30, 2000 (65 FR 64607), FDA published a final rule... of the anniversary date of U.S. approval of the original application. In fiscal year 2009 (FY09), 25..., FDA completed a consolidation of certain therapeutic products formerly regulated by CBER into...

  15. 77 FR 13339 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements...

    Science.gov (United States)

    2012-03-06

    ... this notice and report. C. FDA's Implementing Regulations On October 30, 2000 (65 FR 64607), FDA... application. In fiscal year 2011 (FY11), 21 percent (43/208) of NDA/ANDA and 41 percent (41/99) of BLA annual... completed a consolidation of certain therapeutic products formerly regulated by CBER into CDER....

  16. Post-marketing management of the use of non-narcotic analgesics.

    Science.gov (United States)

    Miettinen, O S

    1986-01-01

    While the use of non-narcotic analgesics is of considerable health benefit to people everywhere, they also represent a health problem. This problem has to do more with the risks associated with individual courses of treatment than with the commonality of those treatments. The public health challenge in post-marketing management of non-narcotic analgesic use, is to promote a pattern of use such that the risks are justifiable by the benefits and are the lowest that can be attained. To achieve such goals it is essential to have scientific knowledge about the benefits and risks and to be able to determine the quality of use in the population as to how proper it is. Current post-marketing management programmes focus largely on regulation, overlooking other equally important basic methods of public health intervention, namely education and service. If it is accepted that mass education is the key element in the proper management of non-narcotic analgesic use, the present emphasis on regulation needs amendment. Such changes will take time, but it is conceivable that ultimately the management goal can be achieved with minimal regulatory intervention.

  17. 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.

  18. Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases

    Directory of Open Access Journals (Sweden)

    Xue-Lin Li

    2015-01-01

    Full Text Available Traditional Chinese medicine injections (TCMIs have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs of TCMIs have increased year by year. Danhong injection (DHI is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved.

  19. Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases.

    Science.gov (United States)

    Li, Xue-Lin; Tang, Jin-Fa; Li, Wei-Xia; Li, Chun-Xiao; Zhao, Tao; Zhao, Bu-Chang; Wang, Yong; Zhang, Hui; Chen, Xiao-Fei; Xu, Tao; Zhu, Ming-Jun

    2015-01-01

    Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved.

  20. [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

  1. 76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505...

    Science.gov (United States)

    2011-04-01

    ... Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.'' The... clinical trials for prescription drugs approved under the FD&C Act and biological products approved under... of the new provisions and a description of the types of postmarketing studies and clinical...

  2. 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.

  3. 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

  4. 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)

    Kumakech, Edward; 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.

  5. 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.)

  6. 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.)

  7. [Results of a post-marketing surveillance of meropenem administered over 2 g/day for serious infectious diseases].

    Science.gov (United States)

    Wakisaka, Koji; Tani, Shunsuke; Ishibashi, Kazuo; Nukui, Kazuhiko; Nagao, Munehiko

    2015-10-01

    The post-marketing surveillance of meropenem (Meropen®) administered over 2g/day for serious infectious diseases was conducted between August 2011 and June 2013 to evaluate safety and efficacy under actual clinical use. There were 382 and 322 evaluable cases for safety and efficacy respectively, of 399 case cards collected from 87 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 19.1% (73/382 cases), and the main ADRs were hepatic function abnormal, aspartate aminotransferase increased, alanine aminotransferase increased, liver disorder, and diarrhoea, which were similar to these observed in the post-marketing surveillances of meropenem conducted before. In efficacy analysis, the efficacy was 73.6% (237/322 cases), which is as same as 71.4% (3214/4504 cases) of post-marketing surveillance of meropenem conducted after first approval under 2 g/day for infectious diseases. These results confirmed meropenem (Meropen®) is one of the useful antimicrobial agents for serious infectious diseases.

  8. 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.

  9. 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.

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

    Science.gov (United States)

    Zhu, Xiao; Kruhlak, Naomi L

    2014-07-01

    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.

  11. 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

  12. 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.

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

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

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

  14. 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...

  15. Post-marketing safety surveillance conducted in Korea (2008–2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™)

    Science.gov (United States)

    Shin, Son Moon; Kim, Chun Soo; Karkada, Naveen; Liu, Aixue; Jayadeva, Girish; Han, Htay Htay

    2016-01-01

    ABSTRACT Purpose: According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). Methods: During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. Results: A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. Conclusions: We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice. PMID:27494163

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

    Directory of Open Access Journals (Sweden)

    Jara M

    2015-12-01

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

  17. 21 CFR 822.32 - What records are the investigators in my surveillance plan required to keep?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false What records are the investigators in my surveillance plan required to keep? 822.32 Section 822.32 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Records...

  18. [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

  19. [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

  20. 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

  1. [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

  2. 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 ...

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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... experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The... drugs) or a Periodic Adverse Experience Report (PAER) (for biologics) (21 CFR 314.80(c)(2) and...

  8. 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.

  9. 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

  10. 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

  11. 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.

  12. [Planning, realization and evaluation of post-marketing surveillance studies. Recommendations of the Society for Phytotherapy].

    Science.gov (United States)

    Kraft, K; Loew, D; Schneider, B; Kemper, F H

    1997-08-01

    Post-marketing-surveillance studies with herbal drugs usually are prospective prescription-epidemiological studies, which should allow statements on quality, efficacy and safety. Until now neither laws nor concrete normative guidelines for the methodology and the evaluation of post-marketing-surveillance studies are existing which could be used for pharmacovigilance. In the present paper guidelines for planning, realisation and evaluation are presented which should allow studies of high quality. The essential components required for the investigational plan are focussed. Also recommendations on the obligatory, optional and special components of the study protocols are made. Additionally statistical methods which allow the evaluation of the therapeutic efficacy are presented.

  13. 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.

  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. Safety experience with bosentan in 146 children 2-11 years old with pulmonary arterial hypertension: results from the European Postmarketing Surveillance program

    DEFF Research Database (Denmark)

    Beghetti, M.; Hoeper, M.M.; Kiely, D.G.;

    2008-01-01

    The oral dual endothelin receptor antagonist bosentan has been shown to improve the short- and medium-term course of adult pulmonary arterial hypertension (PAH); however, data from clinical studies in children are limited. This analysis investigated the safety profile of bosentan in pediatric...... patients in a European, prospective, noninterventional, Internet-based postmarketing surveillance database (Tracleer PMS). Pediatric patients (aged 2-11 y) were compared with patients aged > or =12 y. Over a 30-mo period, 4994 patients, including 146 bosentan-naive pediatric patients (51.4% males), were...... captured in the database. Predominant etiologies in children were idiopathic PAH (40.4%) and PAH related to congenital heart disease (45.2%). The majority of children were in New York Heart Association functional class II (28.1%) or III (50.7%), and median exposure to bosentan was 29.1 wk. Elevated...

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

    Science.gov (United States)

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

    2011-01-01

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

  17. Prescription practice of biological drugs in rheumatoid arthritis during the first three years of postmarketing use in Denmark and Norway: criteria are becoming less stringent

    DEFF Research Database (Denmark)

    Hjardem, Elisabeth; Hetland, Merete; Østergaard, Mikkel;

    2005-01-01

    -blocking agents if the prescription guidelines of the United Kingdom (UK) and Holland were applied. METHODS: Rheumatoid arthritis (RA) patients receiving TNF-blocking agents from Denmark (n= 823, age: 55.2 yrs, 72.2% women) and Norway (n= 371, age: 51.8 yrs, 75.4% women) were registered from 2000 to 2003 and each......OBJECTIVE: This study is based on the Danish DANBIO and the Norwegian NOR-DMARD databases. It was undertaken to investigate changes in prescription practice during the first three years of post-marketing use of biological drugs, and to find the proportion of patients who would not have received TNF.......5% and 5.7% did not meet the Dutch criteria. CONCLUSION: The Danish and Norwegian prescription practices of biological therapies in RA were similar, and became less stringent from 2000 to 2003. Prescriptions agreed well with the Dutch guidelines, while almost half of the patients did not meet the UK...

  18. The value of population pharmacokinetics and simulation for postmarketing safety evaluation of dosing guidelines for drugs with a narrow therapeutic index: buflomedil as a case study.

    Science.gov (United States)

    Bourguignon, Laurent; Ducher, Michel; Matanza, David; Bleyzac, Nathalie; Uhart, Mathieu; Odouard, Emmanuel; Maire, Pascal; Goutelle, Sylvain

    2012-04-01

    Population pharmacokinetics and simulation techniques currently play an important role in new drug development. This paper illustrates the potential value of those methods in postmarketing safety assessment, using buflomedil in elderly patients as an example. We retrospectively assessed the risk of buflomedil overdosing associated with the latest dosing recommendations of the French Drug Agency (AFSSAPS). First, buflomedil concentrations measured in 24 elderly patients were analysed with a nonparametric population approach. Then, the pharmacokinetic model was used to perform a 1000-patient Monte Carlo simulation for the two recommended buflomedil dosage regimens. The maximum concentrations calculated after 10 days of therapy were compared with levels observed in reported cases of toxicity to assess the probability of overdosing. A three-compartment model best fit concentration data. Population predictions showed little bias (-0.14 mg/L) and good precision (8.73 mg(2) /L(2)). Overall results of the simulation study showed that the application of the two recommended dosage regimens of buflomedil was associated with overdosing (C(max) > 10 mg/L) and potential toxicity in 2.9% of geriatric patients. In patients with mild renal impairment, who may receive the higher-dosage regimen by therapeutic error, the probability of overdosing was 6.2%. Despite specific dosing recommendations in case of renal impairment, this study shows that the use of buflomedil could be associated with significant risk of overdosing in geriatric patients. Such results might have enhanced decision-making when buflomedil safety was reassessed by AFSSAPS in 2006. The retrospective case of buflomedil illustrates how these methods may be valuable in postmarketing safety evaluation of potentially toxic drugs.

  19. 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

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

    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...

  1. 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...

  2. 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...

  3. 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...

  4. 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.

  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. [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.

  7. Evaluation of safety and efficacy of ketoconazole 2% and zinc pyrithione 1% shampoo in patients with moderate to severe dandruff--a postmarketing study.

    Science.gov (United States)

    Saple, D G; Ravichandran, G; Desai, A

    2000-12-01

    A postmarketing study was conducted on 236 patients from 23 centres suffering from moderate to severe dandruff with a combination of ketoconazole and zinc pyrithione (1%) for a duration of 4 weeks with 2 weeks further follow-up. Scoring of dandruff was done on a 0-10 scale for each of the 6 regions of scalp at each week up to 6 weeks. The results indicate that there was a consistent improvement in dandruff scores over the treatment period and a reduction of > 90% was seen for all areas of scalp individually as well as collectively as compared to baseline. The treatment also showed significant improvement in other signs and symptoms such as erythema and itching, with a highly favourable adverse event profile. The overall assessment for global improvement by investigators showed good-excellent results with high acceptability amongst the patient population for the treatment. A combination shampoo of ketoconazole (2%) and zinc pyrithione (1%) offers a safe and effective option in the treatment of dandruff.

  8. 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.

  9. 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

  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. 76 FR 78284 - Pediatric Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-16

    ... Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine... accommodate persons with physical disabilities or special needs. If you require special accommodations due...

  15. 欧盟药品上市后抽验模式分析与启示%A look into the EU post-marketing sampling and testing model and its inspiration to China

    Institute of Scientific and Technical Information of China (English)

    孙苓苓; 毕开顺

    2012-01-01

    Due to the large number of pharmaceutical manufacturers and intermediate links in China as well as the incomplete market security system, there are many factors that affect drug quality, and drug safety problems have attracted more and more attention. Compared with our country, European Union ( EU) has already set up a full equipped marketing sampling and testing system. This article gives an introduction of their surveillance and testing bodies and studies the Centrally Authorised Products (CAP) sampling and testing and the Mutual Recognition Procedure (MRP)/Decentralised Procedure (DCP) products post-marketing surveillance models, thus to provide reference for our own work.%由于我国药品生产企业数目众多,流通环节众多,市场保障体系建立尚不完全,因而影响药品安全的风险因素也较多,药品质量问题越来越引起了国家与公众的重视.与我国相比,欧盟已经建立了完善的药品抽验体系,本文通过对欧盟上市后药品抽验监管机构及技术机构的介绍,并对集中抽验和市场监督抽验两种模式进行研究,为我国上市后药品的评价性抽验和市场监督抽验提供借鉴.

  16. 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

  17. 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.

  18. Energy requirements

    NARCIS (Netherlands)

    Hulzebos, Christian V.; Sauer, Pieter J. J.

    2007-01-01

    The determination of the appropriate energy and nutritional requirements of a newborn infant requires a clear goal of the energy and other compounds to be administered, valid methods to measure energy balance and body composition, and knowledge of the neonatal metabolic capacities. Providing an appr

  19. [Drug registries: post-marketing evaluation of the benefit-risk profile and promotion of appropriateness. The regional point of view].

    Science.gov (United States)

    Martelli, Luisa; Venegoni, Mauro

    2013-06-01

    Italian Regions and the Italian regulatory agency share a common interest in promoting the appropriateness of drug use, containing drug expenditure and acquiring additional evidence on the effectiveness and safety of drugs. Drug registries can help attaining these objectives. Specifically, the registries implemented in Italy were able to cover the first two objectives, whereas some critical issues were raised on the third one. For instance, the data recorded in the registries are not available at regional level to conduct safety and effectiveness investigations. This is a paradox, when considering that drugs included in the registries have a risk-benefit profile that is only partially defined at the moment of marketing. Currently, researchers and regions can conduct epidemiological research (cohort and case control studies), on the basis of record-linkage procedures, on all drugs prescribed in general practice (which are older drugs with a better defined risk-benefit profile). The expected outcomes of registries should be more clearly defined: when the main aim is to promote appropriateness, the recording of only a very limited amount of data should be required (to avoid a bureaucratic burden on clinicians).The Italian centers of the ENCePP network might play an important role in planning and conducting drug registries: through the presence in the steering committees of the registries, and in conducting epidemiological studies that make the most of this powerful instrument.

  20. 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

  1. Progress of Post-marketing Surveillance on Adverse Events Following Immunization of the Pandemic Influenza A(H1N1) Vaccine%甲型H1N1流行性感冒疫苗疑似预防接种异常反应监测进展

    Institute of Scientific and Technical Information of China (English)

    吴冰冰; 刘大卫; 李克莉; 武文娣; 许涤沙; 贾磊

    2011-01-01

    甲型H1N1流行性感冒(甲流)疫苗上市后,疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)监测是评价甲流疫苗安全性的重要方法.文章对各国甲流疫苗的监测概况和监测结果 进行了综述.%Post-marketing surveillance on Adverse Events Following Immunization (AEFI)is crucial for evaluating the safety of vaccines against the pandemic influenza A (H1N1)virus.Progress of postmarketing surveillance of AEFI of the pandemic influenza A(H1N1 )vaccine among countries has been reviewed in this article.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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...

  7. Feed tank transfer requirements

    Energy Technology Data Exchange (ETDEWEB)

    Freeman-Pollard, J.R.

    1998-09-16

    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.

  8. 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

  9. 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.

  10. 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 ...

  11. 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...

  12. 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...

  13. 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

  14. 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....

  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. 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.

  17. 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...

  18. 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

  19. 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.

  20. Creativity in Requirement Identification

    OpenAIRE

    Sørensen, Lene Tolstrup; Olesen, Henning

    2008-01-01

    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...

  1. 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...

  2. Testing agile requirements models

    Institute of Scientific and Technical Information of China (English)

    BOTASCHANJANJewgenij; PISTERMarkus; RUMPEBernhard

    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. User Requirements for Wireless

    DEFF Research Database (Denmark)

    In most IT system development processes, the identification or elicitation of user requirements is recognized as a key building block. In practice, the identification of user needs and wants is a challenge and inadequate or faulty identifications in this step of an IT system development can cause...... in the elicitation process. Cases and user requirement elements discussed in the book include: User requirements elicitation processes for children, construction workers, and farmers User requirements for personalized services of a broadcast company Variations in user involvement Practical elements of user...

  5. 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.

  6. 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...

  7. 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....

  8. 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,...

  9. 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...

  10. Ecodesign requirements for televisions

    DEFF Research Database (Denmark)

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

    2013-01-01

    Purpose This paper concerns the Ecodesign Directive (2009/125/EC) and the implementing measures (IM) in which ecodesign requirements are set up for energy-using and energy-related products. Previous studies have found that the requirements have a unilateral focus on energy consumption and the use...... 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 analyse if other environmental hotspots and life cycle phases should be included in the requirements in the IM of the Ecodesign Directive besides energy consumption in the use phase analysis. Methods The consequential approach is used. The data for the LCA have been gathered from two manufacturers of TVs...

  11. Requirements management at NASA

    Science.gov (United States)

    Rosenburg, L.

    2001-01-01

    Requirements have always been acknowledged as the backbone of any system. However, in many past development efforts, requirements were paid little heed. At NASA, in recent years, the hue and cry for project development has been "Faster, Better, Cheaper and Safer". This has impacted the way we develop software; it has increased the risks to quality, safety and reliability. At NASA, the Software Assurance Technology Center (SATC) is working with projects to emphasize the criticality of requirements throughout development, not just in the initial phases. This emphasis is on requirements relationship to all aspects of quality, including reliability and safety. In this presentation, we will look at some of these relationships through the eyes of quality.

  12. 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.

  13. CLIC Detector Power Requirements

    CERN Document Server

    Gaddi, A

    2013-01-01

    An estimate for the CLIC detector power requirements is outlined starting from the available data on power consumptions of the four LHC experiments and considering the differences between a typical LHC Detector (CMS) and the CLIC baseline detector concept. In particular the impact of the power pulsing scheme for the CLIC Detector electronics on the overall detector consumption is considered. The document will be updated with the requirements of the sub-detector electronics once they are more defined.

  14. Uniform Requirements for Manuscripts

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    @@ Introduction The Uniform requirements are instructions to authors on how to prepare manuscripts.If authors prepare their manuscripts in the style specified in these requirements, editors of the participating journals will not return the manuscripts for changes in style before considering them for publication.In the publishing process, however, the journals may alter accepted manuscripts to conform with details of their publication styles.

  15. 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

  16. Utility requirements for fusion

    Energy Technology Data Exchange (ETDEWEB)

    Vondrasek, R.J.

    1982-02-01

    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.

  17. 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.

  18. 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.

  19. Requirements for Xenon International

    Energy Technology Data Exchange (ETDEWEB)

    Hayes, James C.; Ely, James H.

    2013-09-26

    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.

  20. 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.

  1. INDECT Advanced Security Requirements

    CERN Document Server

    Uruena, Manuel; Martinez, Maria; Niemiec, Marcin; Stoianov, Nikolai

    2010-01-01

    This paper reviews the requirements for the security mechanisms that are currently being developed in the framework of the European research project INDECT. An overview of features for integrated technologies such as Virtual Private Networks (VPNs), Cryptographic Algorithms, Quantum Cryptography, Federated ID Management and Secure Mobile Ad-hoc networking are described together with their expected use in INDECT.

  2. 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.

  3. 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

  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. 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...... apply in industry. The findings of this study show that SME managers employ a practice-shaped holistic multi- and cross-disciplinary approach to learning. This learning approach is supported by theory dissemination, business challenge applications, and organisational prerequisites. Diversified learning...... 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....

  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. 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.

  8. Creativity, Requirements and Perspectives

    Directory of Open Access Journals (Sweden)

    Oliver Hoffmann

    2005-11-01

    Full Text Available Is there room for more creativity in information systems? This article grew out of an AWRE’04 panel discussion on creativity in requirements engineering, and the impact of requirements engineering on creativity in systems engineering and systems use. Both panel and article were motivated by the goal of identifying a framework for understanding creativity in a larger context and thus establishing a potential structure for future research. The authors’ research backgrounds differ widely and, at times, our views conflict – occasionally, quite sharply. We make underlying world views - our own and those of relevant disciplines – explicit; identify the paradox caused by the need to be functionally creative while leaving room for creativity in successive stages; and argue for a multi-paradigm framework for resolving this paradox.

  9. [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

  10. Stylistic Requirement for Translation

    Institute of Scientific and Technical Information of China (English)

    HOU Yin-zhen

    2016-01-01

    Stylistic research is subordinate to language use research. The fast maturing modern stylistics has greatly boosted trans-lation studies. Translation has a close relationship with stylistics. Many problems can be solved in translation practice by stylis-tic theories and analysis methods. Based on a brief introduction of stylistics and the relationship between stylistics and transla-tion, this paper will give a specific analysis of the stylistic requirement for translation.

  11. 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.

  12. 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.

  13. 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

  14. 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...

  15. 76 FR 40374 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-07-08

    ... Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs... a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs--(OMB... Act, which requires that FDA publish a list of all authorized generic drugs included in an...

  16. 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.

  17. 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.

  18. 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...

  19. 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.

  20. 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.

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. Internationalization of regulatory requirements.

    Science.gov (United States)

    Juillet, Y

    2003-02-01

    The aim of harmonisation of medicines regulatory requirements is to allow the patient quicker access to new drugs and to avoid animal and human duplications. Harmonisation in the European Union (EU) is now completed, and has led to the submission of one dossier in one language study leading to European marketing authorizations, thanks in particular to efficacy guidelines published at the European level. With the benefit of the European experience since 1989, more than 40 guidelines have been harmonised amongst the EU, Japan and the USA through the International Conference on Harmonisation (ICH). ICH is a unique process gathering regulators and industry experts from the three regions. Its activity is built on expertise and trust. The Common Technical Document (CTD), an agreed common format for application in the three regions, is a logical follow-up to the ICH first phase harmonising the content of the dossier. The CTD final implementation in July 2003 will have considerable influence on the review process and on the exchange of information in the three regions.

  7. 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.

  8. Requirements Reasoning for Distributed Requirements Analysis using Semantic Wiki

    NARCIS (Netherlands)

    Liang, Peng; Avgeriou, Paris; Clerc, Viktor

    2009-01-01

    In large-scale collaborative software projects, thousands of requirements with complex interdependencies and different granularity spreading in different levels are elicited, documented, and evolved during the project lifecycle. Non-technical stakeholders involved in requirements engineering activit

  9. 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.

  10. 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…

  11. 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…

  12. 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

  13. Writing Software Requirements Specification Quality Requirements:An Approach to Manage Requirements Volatility

    Directory of Open Access Journals (Sweden)

    G. SWATHI

    2011-05-01

    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.

  14. 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

  15. National Ignition Facility site requirements

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-07-01

    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.

  16. 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

  17. 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...

  18. USDA registration and rectification requirements

    Science.gov (United States)

    Allen, R.

    1982-01-01

    Some of the requirements of the United States Department of Agriculture for accuracy of aerospace acquired data, and specifically, requirements for registration and rectification of remotely sensed data are discussed. Particular attention is given to foreign and domestic crop estimation and forecasting, forestry information applications, and rangeland condition evaluations.

  19. 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

  20. Energy requirements of adult cats.

    Science.gov (United States)

    Bermingham, Emma N; Thomas, David G; Morris, Penelope J; Hawthorne, Amanda J

    2010-04-01

    A meta-analysis was carried out in order to establish the energy requirements of adult cats. Publications that identified cat body weight (BW) were used to generate allometric relationships between energy requirements and BW of healthy adult cats, using log-log linear regression. Energy requirements were expressed in kcal/kg BW to be consistent with those reported by the National Research Council. Mean maintenance energy requirements were 55.1 (se 1.2) kcal/kg BW (115 treatment groups). Three allometric equations were identified to predict the energy requirements for maintenance of BW in the cat based on BW: light (53.7 kcal/kg BW- 1.061), normal (46.8 kcal/kg BW- 1.115) and heavy (131.8 kcal/kg BW- 0 .366). When reported on lean mass, the allometric equation revealed maintenance requirements were 58.4 kcal/kg lean mass- 1.140 (adjusted R2 0.694; thirty-six treatment groups). The present review suggests that values for maintenance energy requirements based on BW alone may not be an accurate prediction and more detailed information on the age, sex and neuter status, BW and composition would enhance the ability to interpret the maintenance energy requirements of cats.

  1. 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.

  2. 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.

  3. 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.

  4. Requirements for airborne vector gravimetry

    Science.gov (United States)

    Schwarz, K. P.; Colombo, O.; Hein, G.; Knickmeyer, E. T.

    1992-01-01

    The objective of airborne vector gravimetry is the determination of the full gravity disturbance vector along the aircraft trajectory. The paper briefly outlines the concept of this method using a combination of inertial and GPS-satellite data. The accuracy requirements for users in geodesy and solid earth geophysics, oceanography and exploration geophysics are then specified. Using these requirements, accuracy specifications for the GPS subsystem and the INS subsystem are developed. The integration of the subsystems and the problems connected with it are briefly discussed and operational methods are indicated that might reduce some of the stringent accuracy requirements.

  5. 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

  6. Agent Based Multiviews Requirements Model

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    Based on the current researches of viewpoints oriented requirements engineering and intelligent agent, we present the concept of viewpoint agent and its abstract model based on a meta-language for multiviews requirements engineering. It provided a basis for consistency checking and integration of different viewpoint requirements, at the same time, these checking and integration works can automatically realized in virtue of intelligent agent's autonomy, proactiveness and social ability. Finally, we introduce the practical application of the model by the case study of data flow diagram.

  7. 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.

  8. 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.

  9. 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...

  10. Refrigeration engineering - facing new requirements

    Energy Technology Data Exchange (ETDEWEB)

    Heinrich, G.

    1988-01-01

    From an analysis about the level of development in GDR's refrigeration engineering is derivated, that new requirements on refrigeration demand an effective push of development. Essentially are named as new requirements: reconstruction and improvement of food industry; key and high production-engineering; rational application of energy; utilization of geothermal energy; environmental protection and flue gas desulphurization; fluorochlorohydrocarbon/ozone problem; refrigerant mixtures; gas decomposition; high temperature superconduction; medical refrigeration; electronics application.

  11. 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.

  12. Sterol requirements in Drosophila melanogaster

    OpenAIRE

    Almeida de Carvalho, Maria Joao

    2009-01-01

    Sterol is an abundant component of eukaryotic cell membranes and is thought to influence membrane properties such as permeability, fluidity and microdomain formation. Drosophila is an excellent model system in which to study functional requirements for membrane sterol because, although it does not synthesize sterol, it nevertheless requires sterols to complete development. Moreover, Drosophila normally incorporates sterols into cell membranes. Thus, dietary sterol depletion can be used to ...

  13. Revisiting the Meaning of Requirements

    Institute of Scientific and Technical Information of China (English)

    Zhi Jin

    2006-01-01

    Understanding the meaning of requirements can help elicit the real world requirements and refine their specifications. But what do the requirements of a desired software mean is not a well-explained question yet though there are many software development methods available. This paper suggests that the meaning of requirements could be depicted by the will-to-be environments of the desired software, and the optative interactions of the software with its environments as well as the causal relationships among these interactions. This paper also emphasizes the necessity of distinguishing the external manifestation from the internal structure of each system component during the process of requirements decomposition and refinement. Several decomposition strategies have been given to support the continuous decomposition. The external manifestation and the internal structure of the system component have been defined. The roles of the knowledge about the environments have been explicitly described. A simple but meaningful example embedded in the paper illustrates the main ideas as well as how to conduct the requirements decomposition and refinement by using these proposed strategies.

  14. 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.

  15. Stone dust requirements and options

    Energy Technology Data Exchange (ETDEWEB)

    David Humphreys; Terry O' Beirne [ACIRL (Australia)

    2000-10-01

    This project investigated the level of stone dusting required to inert Australian coals to prevent the propagation of a coal dust explosion. Coal samples from Australian mines were tested to determine individual inerting levels and other explosibility factors. These properties were correlated against other coal properties such as volatile content and vitrinite reflectance. The impacts of ignition energy in the test apparatus and of the presence of methane presence were examined. Results show that the inerting requirements for individual coals are not correlated to volatile content or any other common coal property. For the range of coals mined by underground methods in Australia, the individual inerting requirement varies from 83% to 85% total incombustible content (TIC) which is the stone dust plus ash and moisture from the coal. The impact of methane is to increase the inerting requirement by 5% TIC for the first 1% of methane present. Large-scale testing of one of the Australian coals was undertaken at the Klopperbos facility in South Africa to be compared against the results obtained in the laboratory. The results obtained indicated an inerting requirement of between 81.8% and 86.3% compared to the laboratory results of 84.3% at 5kJ ignition energy.

  16. 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.

  17. 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.

  18. Velocity requirements for causality violation

    CERN Document Server

    Modanese, Giovanni

    2013-01-01

    It is known that the hypothetical existence of superluminal signals would imply the logical possibility of active causal violation: an observer in relative motion with respect to a primary source could in principle emit secondary superluminal signals (triggered by the primary ones) which go back in time and deactivate the primary source before the initial emission. This is a direct consequence of the structure of the Lorentz transformations, sometimes called "Regge-Tolman paradox". It is straightforward to find a formula for the velocity of the moving observer required to produce the causality violation. When applied to some recent claims of slight superluminal propagation, this formula yields a required velocity very close to the speed of light; this raises some doubts about the real physical observability of such violations. We re-compute this velocity requirement introducing a realistic delay between the reception of the primary signal and the emission of the secondary. It turns out that for -any- delay it...

  19. 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

  20. 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

  1. 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...

  2. Coke quality requirements in POSCO

    Energy Technology Data Exchange (ETDEWEB)

    Song, J.; Yi, J.; Wang, H. [POSCO (Republic of Korea). Cokemaking Dept.

    2001-07-01

    The 26 overheads describes coke quality requirements in POSCO, Republic of Korea. It is concluded that it is necessary to develop new coal and to prompt technical development in order to produce high quality coke. To improve coke quality. Posco had applied DMAIC (define, measurement, analysis, improvement, control) technique which is part of Six-Sigma activity.

  3. 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.

  4. 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.

  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. 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...

  7. 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....

  8. 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

  9. 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.

  10. 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...

  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. 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. 

  13. Translation of Requirements Engineering Models

    OpenAIRE

    Saidi, Imad,; Dkaki, Taoufiq; Zarour, Nacer,; Charrel, Pierre-Jean

    2015-01-01

    Part 3: Information Systems and Services; International audience; The globalization and the rapid development of information and communication technologies encourage organizations to work together. In software development, many works have emerged to support this cooperation using different tools and methodologies. Most of them focus on the design-stage concerns. However, very little works have dealt with cooperation during the early stage of software projects, namely Requirements Engineering ...

  14. 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 ...

  15. 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,

  16. 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...

  17. 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...

  18. Faulty assumptions for repository requirements

    Energy Technology Data Exchange (ETDEWEB)

    Sutcliffe, W G

    1999-06-03

    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 sign&ant 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.

  19. Velocity Requirements for Causality Violation

    Science.gov (United States)

    Modanese, Giovanni

    We re-examine the "Regge-Tolman paradox" with reference to some recent experimental results. It is straightforward to find a formula for the velocity v of the moving system required to produce causality violation. This formula typically yields a velocity very close to the speed of light (for instance, v/c > 0.97 for X-shaped microwaves), which raises some doubts about the real physical observability of the violations. We then compute the velocity requirement introducing a delay between the reception of the primary signal and the emission of the secondary. It turns out that in principle for any delay it is possible to find moving observers able to produce active causal violation. This is mathematically due to the singularity of the Lorentz transformations for β →1. For a realistic delay due to the propagation of a luminal precursor, we find that causality violations in the reported experiments are still more unlikely (v/c > 0.989), and even in the hypothesis that the superluminal propagation velocity goes to infinity, the velocity requirement is bounded by v/c > 0.62. We also prove that if two oscopic bodies exchange energy and momentum through superluminal signals, then the swap of signal source and target is incompatible with the Lorentz transformations; therefore it is not possible to distinguish between source and target, even with reference to a definite reference frame.

  20. 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 compl......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...

  1. 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.

  2. 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.

  3. 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...

  4. 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.

  5. Flight Guidance System Requirements Specification

    Science.gov (United States)

    Miller, Steven P.; Tribble, Alan C.; Carlson, Timothy M.; Danielson, Eric J.

    2003-01-01

    This report describes a requirements specification written in the RSML-e language for the mode logic of a Flight Guidance System of a typical regional jet aircraft. This model was created as one of the first steps in a five-year project sponsored by the NASA Langley Research Center, Rockwell Collins Inc., and the Critical Systems Research Group of the University of Minnesota to develop new methods and tools to improve the safety of avionics designs. This model will be used to demonstrate the application of a variety of methods and techniques, including safety analysis of system and subsystem requirements, verification of key properties using theorem provers and model checkers, identification of potential sources mode confusion in system designs, partitioning of applications based on the criticality of system hazards, and autogeneration of avionics quality code. While this model is representative of the mode logic of a typical regional jet aircraft, it does not describe an actual or planned product. Several aspects of a full Flight Guidance System, such as recovery from failed sensors, have been omitted, and no claims are made regarding the accuracy or completeness of this specification.

  6. 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

  7. 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

  8. 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...

  9. NASA Orbital Debris Requirements and Best Practices

    Science.gov (United States)

    Hull, Scott

    2014-01-01

    Limitation of orbital debris accumulation is an international and national concern, reflectedin NASA debris limitation requirements. These requirements will be reviewed, along with some practices that can be employed to achieve the requirements.

  10. 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

  11. 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...

  12. Profitable capitation requires accurate costing.

    Science.gov (United States)

    West, D A; Hicks, L L; Balas, E A; West, T D

    1996-01-01

    In the name of costing accuracy, nurses are asked to track inventory use on per treatment basis when more significant costs, such as general overhead and nursing salaries, are usually allocated to patients or treatments on an average cost basis. Accurate treatment costing and financial viability require analysis of all resources actually consumed in treatment delivery, including nursing services and inventory. More precise costing information enables more profitable decisions as is demonstrated by comparing the ratio-of-cost-to-treatment method (aggregate costing) with alternative activity-based costing methods (ABC). Nurses must participate in this costing process to assure that capitation bids are based upon accurate costs rather than simple averages. PMID:8788799

  13. 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.

  14. Symmetric States Requiring System Asymmetry

    Science.gov (United States)

    Nishikawa, Takashi; Motter, Adilson E.

    2016-09-01

    Spontaneous synchronization has long served as a paradigm for behavioral uniformity that can emerge from interactions in complex systems. When the interacting entities are identical and their coupling patterns are also identical, the complete synchronization of the entire network is the state inheriting the system symmetry. As in other systems subject to symmetry breaking, such symmetric states are not always stable. Here, we report on the discovery of the converse of symmetry breaking—the scenario in which complete synchronization is not stable for identically coupled identical oscillators but becomes stable when, and only when, the oscillator parameters are judiciously tuned to nonidentical values, thereby breaking the system symmetry to preserve the state symmetry. Aside from demonstrating that diversity can facilitate and even be required for uniformity and consensus, this suggests a mechanism for convergent forms of pattern formation in which initially asymmetric patterns evolve into symmetric ones.

  15. 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

  16. [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

  17. 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

  18. 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.

  19. 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.

  20. 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.

  1. 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....

  2. 20 CFR 655.152 - Advertising requirements.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Advertising requirements. 655.152 Section 655... Employment in the United States (H-2A Workers) Post-Acceptance Requirements § 655.152 Advertising requirements. All advertising conducted to satisfy the required recruitment activities under § 655.151...

  3. 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,...

  4. 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...

  5. 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...

  6. 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,...

  7. 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...

  8. 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...

  9. 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

  10. Closed Loop Requirements and Analysis Management

    Science.gov (United States)

    Lamoreaux, Michael; Verhoef, Brett

    2015-01-01

    Effective systems engineering involves the use of analysis in the derivation of requirements and verification of designs against those requirements. The initial development of requirements often depends on analysis for the technical definition of specific aspects of a product. Following the allocation of system-level requirements to a product's components, the closure of those requirements often involves analytical approaches to verify that the requirement criteria have been satisfied. Meanwhile, changes that occur in between these two processes need to be managed in order to achieve a closed-loop requirement derivation/verification process. Herein are presented concepts for employing emerging Team center capabilities to jointly manage requirements and analysis data such that analytical techniques are utilized to effectively derive and allocate requirements, analyses are consulted and updated during the change evaluation processes, and analyses are leveraged during the design verification process. Recommendations on concept validation case studies are also discussed.

  11. 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 ...

  12. 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)...

  13. 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...

  14. 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...

  15. 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.

  16. Insulin requirements in type 1 diabetic pregnancy

    DEFF Research Database (Denmark)

    Callesen, Nicoline; Ringholm, Lene; Stage, Edna;

    2012-01-01

    To evaluate the insulin requirements in women with type 1 diabetes during twin pregnancy compared with singleton pregnancy.......To evaluate the insulin requirements in women with type 1 diabetes during twin pregnancy compared with singleton pregnancy....

  17. 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.

  18. 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...

  19. 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...

  20. 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...

  1. 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... STATUS TO THAT OF PERSON ADMITTED FOR PERMANENT RESIDENCE § 245.4 Documentary requirements. The provisions of part 211 of this chapter relating to the documentary requirements for immigrants shall...

  2. 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...

  3. 28 CFR 26.22 - Requirements.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Requirements. 26.22 Section 26.22 Judicial Administration DEPARTMENT OF JUSTICE DEATH SENTENCES PROCEDURES Certification Process for State Capital Counsel Systems § 26.22 Requirements. A state meets the requirements for certification under 28...

  4. 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...

  5. 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...

  6. 40 CFR 63.1110 - Reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... Control Technology Standards § 63.1110 Reporting requirements. (a) Required reports. Each owner or... should be addressed, if different than the owner or operator. (3) The address (physical location) of the... activity is required to take place. The owner or operator shall include in the request whatever...

  7. 12 CFR 932.7 - Reporting requirements.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Reporting requirements. 932.7 Section 932.7 Banks and Banking FEDERAL HOUSING FINANCE BOARD FEDERAL HOME LOAN BANK RISK MANAGEMENT AND CAPITAL STANDARDS FEDERAL HOME LOAN BANK CAPITAL REQUIREMENTS § 932.7 Reporting requirements. Each Bank shall...

  8. 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....

  9. 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 §...

  10. 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...

  11. 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...

  12. 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...

  13. 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....

  14. 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...

  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 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...

  19. Variations in land requirements for meat production

    NARCIS (Netherlands)

    Elferink, E. V.; Nonhebel, S.

    2007-01-01

    Production of meat requires substantial amounts of feed grains which in turn require vast amounts of land. Future population growth and increase in consumption will raise the demand for meat and with it the land required for meat production. This paper analyses the various factors that affect land r

  20. 32 CFR 552.56 - Licensing requirements.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Licensing requirements. 552.56 Section 552.56....56 Licensing requirements. To transact personal commercial business on military installations in the... meet the licensing requirements of the State in which the installation is located. They must also...

  1. 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...

  2. 7 CFR 3418.4 - Reporting requirement.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Reporting requirement. 3418.4 Section 3418.4..., AND EXTENSION SERVICE, DEPARTMENT OF AGRICULTURE STAKEHOLDER INPUT REQUIREMENTS FOR RECIPIENTS OF AGRICULTURAL RESEARCH, EDUCATION, AND EXTENSION FORMULA FUNDS § 3418.4 Reporting requirement. Each...

  3. 45 CFR 164.105 - Organizational requirements.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Organizational requirements. 164.105 Section 164.105 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS SECURITY AND PRIVACY General Provisions § 164.105 Organizational requirements. (a)(1)...

  4. 40 CFR 96.6 - Standard requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Standard requirements. 96.6 Section 96.6 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NOX... Trading Program General Provisions § 96.6 Standard requirements. (a) Permit Requirements. (1) The...

  5. 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...

  6. 16 CFR 432.2 - Required disclosures.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Required disclosures. 432.2 Section 432.2... UTILIZED IN HOME ENTERTAINMENT PRODUCTS § 432.2 Required disclosures. (a) Whenever any direct or indirect... frequency response, in Hertz (Hz), for the rated power output required to be disclosed in paragraph (a)...

  7. 49 CFR 176.118 - Electrical requirement.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Electrical requirement. 176.118 Section 176.118... Requirements for Class 1 (Explosive) Materials Stowage § 176.118 Electrical requirement. (a) Electrical..., opening of switches or circuit breakers, or disconnection from bus bars. The means, or access to the...

  8. 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...

  9. 40 CFR 35.6450 - General requirements.

    Science.gov (United States)

    2010-07-01

    ... STATE AND LOCAL ASSISTANCE Cooperative Agreements and Superfund State Contracts for Superfund Response Actions Copyright Requirements Under A Cooperative Agreement § 35.6450 General requirements. The recipient must comply with the requirements regarding copyrights described in 40 CFR 31.34. The recipient...

  10. 9 CFR 3.104 - Space requirements.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Space requirements. 3.104 Section 3... Marine Mammals Facilities and Operating Standards § 3.104 Space requirements. (a) General. Marine mammals must be housed in primary enclosures that comply with the minimum space requirements prescribed by...

  11. 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)....

  12. SKA Aperture Array Mid Frequency Science Requirements

    CERN Document Server

    Torchinsky, S A; Gunst, A; Faulkner, A J; van Cappellen, W

    2016-01-01

    This document describes the top level requirements for the SKA-AAMID telescope as determined by the SKA key science projects. These include parameters such as operating frequency range,instantaneous bandwidth (total processed bandwidth), field of view (or survey speed, as appropriate), sensitivity, dynamic range, polarization purity etc. Moreover, through the definition of a set of science requirements, this document serves as input to a number of other documents contained within the System Requirements Review package. (particularly SKA-TEL-MFAA-0200005: `SKA-AAMID System Requirements' and SKA-TEL-MFAA-0200008: `MFAA Requirements').

  13. Theory of Regulatory Compliance for Requirements Engineering

    CERN Document Server

    Jureta, Ivan; Mylopoulos, John; Perini, Anna; Susi, Angelo

    2010-01-01

    Regulatory compliance is increasingly being addressed in the practice of requirements engineering as a main stream concern. This paper points out a gap in the theoretical foundations of regulatory compliance, and presents a theory that states (i) what it means for requirements to be compliant, (ii) the compliance problem, i.e., the problem that the engineer should resolve in order to verify whether requirements are compliant, and (iii) testable hypotheses (predictions) about how compliance of requirements is verified. The theory is instantiated by presenting a requirements engineering framework that implements its principles, and is exemplified on a real-world case study.

  14. 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)

  15. 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.

  16. 76 FR 43691 - Unique Device Identification for Postmarket Surveillance and Enforcement; Public Workshop

    Science.gov (United States)

    2011-07-21

    ... information and comments on issues confronting the effective and efficient incorporation of UDIs into... comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane... in the heading of this document. Received comments may be seen in the Division of Dockets...

  17. 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...

  18. 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.

  19. 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.

  20. Analyzing IS User Requirements using Organizational Semiotics

    Directory of Open Access Journals (Sweden)

    Kamyar Raissifar

    2014-09-01

    Full Text Available In recent years, lack of appropriate understanding of IS user requirements, has been one of the most important causes of IS development failure. Therefore, many methods were introduced for better analyzing user requirements; some of them were philosophically different. Organizational semiotics (OS is one of these methods, which with phenomenological and action-oriented view, tries to get better system requirement analysis. In this research, first, organizational semiotics and SSADM was compared, with focus on their ability to elicit and analyze IS user requirements, and then, OS was applied in analyzing an IS requirement analysis case. Research findings show that OS in many dimensions is superior to SSADM; although SSADM has superiority in few dimensions too. Therefore using OS can help analyzing IS user requirements more appropriately.

  1. 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...

  2. Training Requirements and Information Management System

    Energy Technology Data Exchange (ETDEWEB)

    Cillan, T.F.; Hodgson, M.A.

    1992-05-01

    This is the software user's guide for the Training Requirements and Information Management System. This guide defines and describes the software operating procedures as they apply to the end user of the software program. This guide is intended as a reference tool for the user who already has an indepth knowledge of the Training Requirements and Information Management System functions and data reporting requirement.

  3. 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...

  4. 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...

  5. 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 ...

  6. 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.

  7. Requirements for company-wide management

    Science.gov (United States)

    Southall, J. W.

    1980-01-01

    Computing system requirements were developed for company-wide management of information and computer programs in an engineering data processing environment. The requirements are essential to the successful implementation of a computer-based engineering data management system; they exceed the capabilities provided by the commercially available data base management systems. These requirements were derived from a study entitled The Design Process, which was prepared by design engineers experienced in development of aerospace products.

  8. 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.

  9. 48 CFR 203.1003 - Requirements.

    Science.gov (United States)

    2010-10-01

    ... OF DEFENSE GENERAL IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST Contractor Code of Business Ethics and Conduct 203.1003 Requirements. (b) Notification of possible contractor violation....

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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...

  15. 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...

  16. 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...

  17. 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.

  18. Identified adjustability dimensions when generating a product specific requirements specification by requirements reuse

    DEFF Research Database (Denmark)

    Hauksdóttir, Dagný; Mortensen, Niels Henrik; Nielsen, Poul Erik

    2014-01-01

    A requirements reuse setups typically includes reusable requirement set(s) containing a collection of reusable requirements and a number of product specific requirements sets which are drawn from the reusable set(s). The ideal scenario when reusing requirements is that all the product requirements....... An extensive state of the art is included to introduce the presented methods related to each adjustability dimensions. The options for implementing each adjustability dimensions in a requirement reuse approach are illustrated along with a discussion regarding the benefits and issues resulting from each option...

  19. Mixed-Variable Requirements Roadmaps and their Role in the Requirements Engineering of Adaptive Systems

    CERN Document Server

    Jureta, Ivan; Ernst, Neil A

    2011-01-01

    The requirements roadmap concept is introduced as a solution to the problem of the requirements engineering of adaptive systems. The concept requires a new general definition of the requirements problem which allows for quantitative (numeric) variables, together with qualitative (binary boolean) propositional variables, and distinguishes monitored from controlled variables for use in control loops. We study the consequences of these changes, and argue that the requirements roadmap concept bridges the gap between current general definitions of the requirements problem and its notion of solution, and the research into the relaxation of requirements, the evaluation of their partial satisfaction, and the monitoring and control of requirements, all topics of particular interest in the engineering of requirements for adaptive systems [Cheng et al. 2009]. From the theoretical perspective, we show clearly and formally the fundamental differences between more traditional conception of requirements engineering (e.g., Z...

  20. 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...

  1. 40 CFR 444.12 - Monitoring Requirements

    Science.gov (United States)

    2010-07-01

    ... transparent with a turbidity measurement of 1 NTU or less c. Is colorless with no perceptible odor, and d. Is... volume of effluent discharged from each outfall, and other appropriate measurements subject to notification requirements. See 40 CFR 122.44(i). EPA's pretreatment regulations similarly require...

  2. 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...

  3. 8 CFR 1245.4 - Documentary requirements.

    Science.gov (United States)

    2010-01-01

    ... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Documentary requirements. 1245.4 Section 1245.4 Aliens and Nationality EXECUTIVE OFFICE FOR IMMIGRATION REVIEW, DEPARTMENT OF JUSTICE... Documentary requirements. The provisions of part 1211 of this chapter relating to the documentary...

  4. 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)...

  5. The strictest energy requirements in the world

    DEFF Research Database (Denmark)

    Lauridsen, Erik Hagelskjær; Jensen, Jens Stissing

    2013-01-01

    50 years of progressively strengthened energy requirements in the Danish building code appear to be a success, as the energy consumption has remained constant despite an increase in the total area in requirement of heating. This article however argues that the building code mechanism is heavily...

  6. 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

  7. 40 CFR 261.147 - Liability requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 25 2010-07-01 2010-07-01 false Liability requirements. 261.147 Section 261.147 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) IDENTIFICATION AND LISTING OF HAZARDOUS WASTE Financial Requirements for Management of...

  8. 40 CFR 68.195 - Required corrections.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Required corrections. 68.195 Section 68.195 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CHEMICAL ACCIDENT PREVENTION PROVISIONS Risk Management Plan § 68.195 Required corrections. The owner...

  9. 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...

  10. 20 CFR 655.1303 - Advertising requirements.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Advertising requirements. 655.1303 Section... Employment in the United States (H-2A Workers) § 655.1303 Advertising requirements. All advertising conducted... the H-2A workers. All advertising must contain the following information: (a) The employer's name...

  11. 49 CFR 177.834 - General requirements.

    Science.gov (United States)

    2010-10-01

    ... any motor vehicle to keep fire away and to prevent persons in the vicinity from smoking, lighting... the following— (i) The applicable fire suppression requirements in 29 CFR 1910.106(e), (f), (g), (h... and Unloading § 177.834 General requirements. (a) Packages secured in a motor vehicle. Any...

  12. 48 CFR 242.7302 - Requirements.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Requirements. 242.7302 Section 242.7302 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT.../Pension Review 242.7302 Requirements. Follow the procedures at PGI 242.7302 to determine if a CIPR...

  13. 14 CFR 121.378 - Certificate requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Certificate requirements. 121.378 Section 121.378 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED... REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Maintenance, Preventive Maintenance, and...

  14. 7 CFR 1291.11 - Audit requirements.

    Science.gov (United States)

    2010-01-01

    ... PROGRAM-FARM BILL § 1291.11 Audit requirements. Each year that a State receives a grant under the SCBGP-FB, the State is required to conduct an audit of the expenditures of SCBGP-FB funds. If the Single Audit... audit of all SCBGP-FB funds no later than 60 days after the end date of the grant agreement. The...

  15. 21 CFR 640.93 - General requirements.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false General requirements. 640.93 Section 640.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS... requirements. (a) Preservative. The final product shall not contain a preservative. (b) Storage of...

  16. 49 CFR 585.76 - Reporting requirements.

    Science.gov (United States)

    2010-10-01

    ... years as complying with the upgraded moving deformable barrier (S7.2 of Standard No. 214)(49 CFR 571.214... concerning its compliance with the moving deformable barrier requirements of S7 of Standard No. 214 and with... meeting the moving deformable barrier test requirements of S7.2 of Standard No. 214, Side...

  17. 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...

  18. 20 CFR 655.17 - Advertising requirements.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Advertising requirements. 655.17 Section 655... States (H-2B Workers) § 655.17 Advertising requirements. All advertising conducted to satisfy the... employment which are not less favorable than those to be offered to the H-2B workers. All advertising...

  19. 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...

  20. 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...

  1. 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...

  2. 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....

  3. 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...

  4. 76 FR 67323 - Resolution Plans Required

    Science.gov (United States)

    2011-11-01

    ... Liquidation Authority in Title II of the Dodd-Frank Act. Some commenters criticized the corporate governance requirement of the proposed rule. These commenters suggested that a covered company's corporate governance... credible. Another commenter suggested that the corporate governance requirement should include...

  5. 14 CFR 147.15 - Space requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Space requirements. 147.15 Section 147.15 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SCHOOLS AND OTHER CERTIFICATED AGENCIES AVIATION MAINTENANCE TECHNICIAN SCHOOLS Certification Requirements §...

  6. 14 CFR 135.427 - Manual requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Manual requirements. 135.427 Section 135.427 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED... REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT...

  7. 14 CFR 121.369 - Manual requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Manual requirements. 121.369 Section 121.369 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED... REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS Maintenance, Preventive Maintenance, and...

  8. 14 CFR 135.435 - Certificate requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Certificate requirements. 135.435 Section 135.435 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED... REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT...

  9. 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 ...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 50 CFR 648.205 - VMS requirements.

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 8 2010-10-01 2010-10-01 false VMS requirements. 648.205 Section 648.205... Herring Fishery § 648.205 VMS requirements. The owner or operator of any limited access herring vessel with the exception of fixed gear fishermen must install and operate a VMS unit consistent with...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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)...

  1. 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...

  2. 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

  3. 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....

  4. 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....

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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

  19. 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...

  20. 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...

  1. 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,...

  2. 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....

  3. 47 CFR 73.6002 - Licensing requirements.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Licensing requirements. 73.6002 Section 73.6002 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Class A Television Broadcast Stations § 73.6002 Licensing requirements. (a) A Class A...

  4. 47 CFR 74.532 - Licensing requirements.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Licensing requirements. 74.532 Section 74.532 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES EXPERIMENTAL RADIO... § 74.532 Licensing requirements. (a) An aural broadcast STL or an aural broadcast intercity...

  5. 47 CFR 74.632 - Licensing requirements.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Licensing requirements. 74.632 Section 74.632 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES EXPERIMENTAL RADIO... Stations § 74.632 Licensing requirements. (a) Licenses for television pickup, television STL,...

  6. 10 CFR 110.5 - Licensing requirements.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Licensing requirements. 110.5 Section 110.5 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL General Provisions § 110.5 Licensing requirements. Except as provided under subpart B of this part, no person may...

  7. 47 CFR 73.731 - Licensing requirements.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Licensing requirements. 73.731 Section 73.731 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES International Broadcast Stations § 73.731 Licensing requirements. (a) A license for an...

  8. 42 CFR 431.703 - Licensing requirement.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Licensing requirement. 431.703 Section 431.703 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Licensing Nursing Home Administrators § 431.703 Licensing requirement. The State licensing program...

  9. 32 CFR 216.6 - Information requirements.

    Science.gov (United States)

    2010-07-01

    ... EDUCATION § 216.6 Information requirements. The information requirements identified at § 216.5(b) and (c)(1..., ABC University, Anywhere, USA 12345-9876. Dear Dr. Doe: I understand that military recruiting... listing, age (or year of birth), level of education (e.g., freshman, sophomore, or degree awarded for...

  10. 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...

  11. 45 CFR 164.314 - Organizational requirements.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Organizational requirements. 164.314 Section 164.314 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES ADMINISTRATIVE DATA STANDARDS AND RELATED... Information § 164.314 Organizational requirements. (a)(1) Standard: Business associate contracts or...

  12. 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...

  13. 46 CFR 117.25 - Additional requirements.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Additional requirements. 117.25 Section 117.25 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) SMALL PASSENGER VESSELS CARRYING MORE THAN 150... the requirements of this part inadequate; or (2) The vessel is operated in Arctic, Antarctic, or...

  14. 46 CFR 180.25 - Additional requirements.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Additional requirements. 180.25 Section 180.25 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) SMALL PASSENGER VESSELS (UNDER 100 GROSS TONS... the requirements of this part inadequate; or (2) The vessel is operated in Arctic, Antarctic, or...

  15. 40 CFR 72.9 - Standard requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Standard requirements. 72.9 Section 72...) PERMITS REGULATION Acid Rain Program General Provisions § 72.9 Standard requirements. (a) Permit... Quality Standards or State Implementation Plans. (2) Limiting the number of allowances a source can...

  16. 18 CFR 430.15 - Conservation requirements.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Conservation requirements. 430.15 Section 430.15 Conservation of Power and Water Resources DELAWARE RIVER BASIN COMMISSION SPECIAL REGULATIONS GROUND WATER PROTECTION AREA: PENNSYLVANIA § 430.15 Conservation requirements....

  17. 14 CFR 171.207 - Performance requirements.

    Science.gov (United States)

    2010-01-01

    ...) NAVIGATIONAL FACILITIES NON-FEDERAL NAVIGATION FACILITIES VHF Marker Beacons § 171.207 Performance requirements. (a) VHF Marker Beacons must meet the performance requirements set forth in the “International... identification. Identification of a marker beacon (75 MHz) must be in accordance with “U.S. Standard...

  18. 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...

  19. 12 CFR 704.15 - Audit requirements.

    Science.gov (United States)

    2010-01-01

    ... summary of the audit report to the membership at the next annual meeting. (b) Internal audit. A corporate... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Audit requirements. 704.15 Section 704.15 Banks... UNIONS § 704.15 Audit requirements. (a) External audit. The corporate credit union supervisory...

  20. 40 CFR 141.133 - Compliance requirements.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) NATIONAL PRIMARY DRINKING WATER REGULATIONS Disinfectant Residuals, Disinfection Byproducts, and Disinfection Byproduct Precursors § 141.133 Compliance requirements. (a) General requirements. (1) Where... chlorine or chloramine, the system is out of compliance at the end of that quarter. (b)...

  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. 9 CFR 3.128 - Space requirements.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Space requirements. 3.128 Section 3... Mammals Facilities and Operating Standards § 3.128 Space requirements. Enclosures shall be constructed and maintained so as to provide sufficient space to allow each animal to make normal postural and...

  3. Key requirements for future control room functionality

    DEFF Research Database (Denmark)

    Tornelli, Carlo; Zuelli, Roberto; Marinelli, Mattia;

    2016-01-01

    This internal report provides the key requirements for the future control centres. R8.1 represents the starting point of WP8 activities and wants to achieve a double objective. On the one hand it collects general requirements on future control centres emerging from the general trends in power sys...

  4. 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

  5. 49 CFR 1503.101 - TSA requirements.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 9 2010-10-01 2010-10-01 false TSA requirements. 1503.101 Section 1503.101... Scope of Investigative and Enforcement Procedures § 1503.101 TSA requirements. (a) The investigative and enforcement procedures in this part apply to TSA's investigation and enforcement of violations of...

  6. NASA's acquisition requirements for configuration management

    Science.gov (United States)

    Coletta, Mark P.

    1992-01-01

    A viewgraph presentation on NASA's acquisition requirements for configuration management (CM) goes over CM requirements for single mission and multi-mission orientations, CM automation and CALS implementation initiatives, NASA implementation of DOD standards and DID's (data item descriptions), impact of traceability in NASA CM support, NASA's CM efforts in modifying/upgrading equipment, and CM control of multi-vendor hardware.

  7. Cloud computing security requirements: a systematic review

    NARCIS (Netherlands)

    Iankoulova, Iliana; Daneva, Maya; Rolland, C.; Castro, J.; Pastor, O.

    2012-01-01

    Many publications have dealt with various types of security requirements in cloud computing but not all types have been explored in sufficient depth. It is also hard to understand which types of requirements have been under-researched and which are most investigated. This paper's goal is to provide

  8. 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)...

  9. 40 CFR 96.206 - Standard requirements.

    Science.gov (United States)

    2010-07-01

    ... requirements of subpart HHH of this part. (2) The emissions measurements recorded and reported in accordance with subpart HHH of this part shall be used to determine compliance by each CAIR SO2 source with the... HHH of this part. (2) A CAIR SO2 unit shall be subject to the requirements under paragraph (c)(1)...

  10. 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...

  11. 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...

  12. Speech Communication as a Required University Course.

    Science.gov (United States)

    Friedrich, Gustav W.

    1982-01-01

    Argues that a speech communication course should be a required course because speaking and listening are important basic skills which require refinement during a student's college/university years under the guidance of communication professionals. Advises departments to consider the resources (people and material) necessary to develop and…

  13. 40 CFR 257.30 - Recordkeeping requirements.

    Science.gov (United States)

    2010-07-01

    ... Disposal Units Recordkeeping Requirements § 257.30 Recordkeeping requirements. (a) The owner/operator of a non-municipal non-hazardous waste disposal unit must record and retain near the facility in an... FOR CLASSIFICATION OF SOLID WASTE DISPOSAL FACILITIES AND PRACTICES Disposal Standards for the...

  14. 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...

  15. 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...

  16. Predictors of juveniles' noncompliance with probation requirements.

    Science.gov (United States)

    NeMoyer, Amanda; Goldstein, Naomi E S; McKitten, Rhonda L; Prelic, Ana; Ebbecke, Jenna; Foster, Erika; Burkard, Casey

    2014-12-01

    Probation is the most common disposition for adjudicated youth, but little is known about which specific requirements are commonly imposed on juveniles, the requirements with which juveniles most often fail to comply, and how certain youth characteristics and/or imposed requirements might relate to probation noncompliance. An investigation of 120 archived files of youth represented by an urban public defender's office identified 29 probation requirements imposed on youth and 18 requirements with which youth commonly failed to comply. Results revealed that 52% of youth failed to comply with at least one probation requirement; prior probation noncompliance and race were both significantly associated with noncompliance in the examined probation disposition. In addition, the probability of probation noncompliance was significantly higher when youth received either of two substance-related probation requirements: drug tests or drug and alcohol counseling. Such results may prompt further investigation of juvenile probation-related predictors, identify areas of need for clinical service provision to foster successful completion of probation requirements, and help identify areas of potential biases among juvenile court personnel.

  17. 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.

  18. 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...

  19. A fuzzy model for exploiting customer requirements

    Directory of Open Access Journals (Sweden)

    Zahra Javadirad

    2016-09-01

    Full Text Available Nowadays, Quality function deployment (QFD is one of the total quality management tools, where customers’ views and requirements are perceived and using various techniques improves the production requirements and operations. The QFD department, after identification and analysis of the competitors, takes customers’ feedbacks to meet the customers’ demands for the products compared with the competitors. In this study, a comprehensive model for assessing the importance of the customer requirements in the products or services for an organization is proposed. The proposed study uses linguistic variables, as a more comprehensive approach, to increase the precision of the expression evaluations. The importance of these requirements specifies the strengths and weaknesses of the organization in meeting the requirements relative to competitors. The results of these experiments show that the proposed method performs better than the other methods.

  20. 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.

  1. 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.

  2. 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

  3. 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)

  4. 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 ....../36 on the exercise of shareholders' rights in listed companies, which must be implemented by 3 August 2009. It is pointed out that companies may provide with advantage in their articles of association for both the existing and the forthcoming requirements at this early stage....

  5. Quality Assurance Source Requirements Traceability Database

    Energy Technology Data Exchange (ETDEWEB)

    MURTHY, R., NAYDENOVA, A., DEKLEVER, R., BOONE, A.

    2006-01-30

    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.

  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. Shuttle-Attached Manipulator System requirements.

    Science.gov (United States)

    Bodey, C. E.; Cepollina, F. J.

    1973-01-01

    Shuttle mission requirements and cost objectives have led to the selection of a Shuttle-Attached Manipulator System (SAMS) as a general purpose mechanism for docking, payload handling, and the general launch and retrieval of free-flying satellites. SAMS design requirements are discussed, giving attention to end effectors, kinematics, timelines, dynamics, load ratings, TV cameras and lights. Requirements for low-cost payload satellites are considered, taking into account satellites with modular subsystems which are designed for replacement and for resupply in orbit by SAMS.

  9. Optical manufacturing requirements for an AVLIS plant

    Science.gov (United States)

    Primdahl, Keith A.; Chow, Robert; Taylor, John R.

    1997-11-01

    A uranium enrichment plant utilizing atomic vapor laser isotope separation technology is currently being planned. Deployment of the plant will require tens of thousands of commercial and custom optical components and subsystems. The plant optical system will be expected to perform at a high level of optical efficiency and reliability in a high- average-power-laser production environment. During construction, demand for this large number of optics must be coordinated with the manufacturing capacity of the optical industry. The general requirements and approach to ensure supply of optical components is described. Dynamic planning and a closely coupled relationship with the optics industry will be required to control cost, schedule,and quality.

  10. 7 CFR 205.202 - Land requirements.

    Science.gov (United States)

    2010-01-01

    ... Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM Organic Production and Handling Requirements § 205.202 Land...

  11. 40 CFR 63.829 - Recordkeeping requirements.

    Science.gov (United States)

    2010-07-01

    ...) National Emission Standards for the Printing and Publishing Industry § 63.829 Recordkeeping requirements. (a) The recordkeeping provisions of 40 CFR part 63 subpart A of this part that apply and those...

  12. 40 CFR 63.830 - Reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... Emission Standards for the Printing and Publishing Industry § 63.830 Reporting requirements. (a) The reporting provisions of 40 CFR part 63 subpart A of this part that apply and those that do not apply...

  13. 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...

  14. Rationale Management Challenges in Requirements Engineering

    NARCIS (Netherlands)

    Liang, Peng; Avgeriou, Paris; He, Keqing

    2010-01-01

    Rationale and rationale management have been playing an increasingly prominent role in software system development mainly due to the knowledge demand during system evaluation, maintenance, and evolution, especially for large and complex systems. The rationale management for requirements engineering,

  15. 42 CFR 422.501 - Application requirements.

    Science.gov (United States)

    2010-10-01

    ... Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM Application Procedures and Contracts for Medicare Advantage Organizations § 422.501 Application requirements. (a) Scope. This section sets forth...

  16. 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.

  17. 34 CFR 361.60 - Matching requirements.

    Science.gov (United States)

    2010-07-01

    ... REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION STATE VOCATIONAL REHABILITATION SERVICES PROGRAM Financing of State Vocational Rehabilitation Programs § 361.60 Matching requirements. (a) Federal share—(1) General... share for expenditures made for the construction of a facility for community rehabilitation...

  18. 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.

  19. 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.

  20. 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...

  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. 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.

  3. 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.

  4. Dosimetry requirements derived from the sterilization standards

    DEFF Research Database (Denmark)

    Miller, A.

    1998-01-01

    The main standards for radiation sterilization, ISO 11137 and EN 552, rest the documentation for the properly executed sterilization process on dosimetry. Both standards describe general requirements to the dosimetry system: The dose measurements must be traceable to national standards...

  5. 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...

  6. 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.

  7. 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.

  8. 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

  9. 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...

  10. 29 CFR 1926.950 - General requirements.

    Science.gov (United States)

    2010-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Power Transmission and Distribution § 1926.950 General requirements. (a) Application. The occupational safety and health standards contained in...

  11. 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...

  12. 40 CFR 35.6500 - General requirements.

    Science.gov (United States)

    2010-07-01

    ... STATE AND LOCAL ASSISTANCE Cooperative Agreements and Superfund State Contracts for Superfund Response Actions Use of Recipient Employees (âforce Accountâ) Under A Cooperative Agreement § 35.6500 General.... Procurement Requirements Under a Cooperative Agreement...

  13. Change in requirements during the design process

    DEFF Research Database (Denmark)

    Sudin, Mohd Nizam Bin; Ahmed-Kristensen, Saeema

    2011-01-01

    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...... approach was employed to understand the nature of change in requirements during the design process - particularly concerning the initiation, discovery, and motivation of these changes. Semi-structured interviews were adopted as the data collection method. The interviews were transcribed and analysed based...

  14. Vacancy Duration, Wage Offers, and Job Requirements

    DEFF Research Database (Denmark)

    Eriksson, Tor Viking; Chen, Long-Hwa

    is concerned with how vacancy durations vary with firms' minimum wage offers and minimum job requirements (regarding education, skills, age, gender and earlier work experience). The empirical analysis is based on ten employer surveys carried out by the DGBAS on Taiwan during the period 1996-2006. We estimate......Besides wage offers, credentials like education, work experience and skill requirements are key screening tools for firms in their recruitment of new employees. This paper adds some new evidence to a relatively tiny literature on firms' recruitment behaviour. In particular, our analysis...... the business cycle. However, firms vary their skills requirements over the business cycle: our empirical analysis shows that, for a given wage offer, requirements are stricter in recessions and downturns. Separating between reasons for posting vacancies turned out important in explaining differences in vacancy...

  15. 50 CFR 222.301 - General requirements.

    Science.gov (United States)

    2010-10-01

    ... waiver or variation to be lawful. (b) No person shall take, import, export or engage in any other... inspect any fish or wildlife held or to inspect, audit, or copy any permits, books, or records required...

  16. 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.

  17. 12 CFR 722.3 - Appraisals required; transactions requiring a State certified or licensed appraiser.

    Science.gov (United States)

    2010-01-01

    ... is entered into, unless the lease is the economic equivalent of a purchase or sale of the leased real...) Valuation requirement. Secured transactions exempted from appraisal requirements pursuant to paragraphs...

  18. Smart Grid Information Security (IS) Functional Requirement

    OpenAIRE

    Ling, Amy Poh Ai; Masao, Mukaidono

    2011-01-01

    It is important to implement safe smart grid environment to enhance people's lives and livelihoods. This paper provides information on smart grid IS functional requirement by illustrating some discussion points to the sixteen identified requirements. This paper introduces the smart grid potential hazards that can be referred as a triggering factor to improve the system and security of the entire grid. The background of smart information infrastructure and the needs for smart grid IS is descri...

  19. 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, ...

  20. Understanding Social and Environmental Requirements in China

    OpenAIRE

    Liu, Lin

    2009-01-01

    Rapid changes in the social and technical environment bring about many new challenges to system requirements engineering, amongst which out-sourcing or off-shoring of certain design tasks to countries with more human resources and broader markets becomes promising business leverage. Here we report some of the result from an ongoing research project on the survey of requirements practices in China. It is interesting to understand the current status of industrial practices after years' research...

  1. Semantic Approach for Service Oriented Requirements Modeling

    OpenAIRE

    Zhao, Bin; Cai, Guang-Jun; Jin, Zhi

    2010-01-01

    International audience Services computing is an interdisciplinary subject that devotes to bridging the gap between business services and IT services. It is recognized that Requirements Engineering is fundamental in implementing the service oriented architecture. It takes traditional RE techniques great efforts to model business requirements and search for the appropriate services. In this paper, we propose an ontological approach to facilitate the service-oriented modeling framework. The g...

  2. Generation of the Data Required by AGNPS

    Institute of Scientific and Technical Information of China (English)

    于苏俊

    2003-01-01

    Remote sensing techniques and geographic information systems offer a good means of collecting and manipulating the data required to assess conservation practices. A method for automatic generation of most of the data required by the agricultural non-point source (AGNPS) erosion model is put forward from three sources: (1) files with contour lines from topographic maps, (2) soil mapping units from soil surveys, and (3) land cover from land-sat TM image classifications.

  3. Pulse source requirements for OTDM systems

    DEFF Research Database (Denmark)

    Clausen, Anders; Poulsen, Henrik Nørskov; Oxenløwe, Leif Katsuo;

    2003-01-01

    A simulation model for investigating the impact of incoherent crosstalk due to pulse tail overlapping is proposed. Requirements to pulse width and pulse tail extinction ratio introducing a maximum of 1 dB penalty is extracted.......A simulation model for investigating the impact of incoherent crosstalk due to pulse tail overlapping is proposed. Requirements to pulse width and pulse tail extinction ratio introducing a maximum of 1 dB penalty is extracted....

  4. USMC tactical motor transport lift requirements model

    OpenAIRE

    Allen, Scott Andrew

    1995-01-01

    This thesis concentrates on developing a spreadable model that can be used by Marine logisticians in computing sustainment requirements and the resulting tactical motor transport lift requirements necessary to keep a notional sized maneuver element supported on a daily basis in the Marine Corps projected maneuver warfare environment. Sustainment computations are limited to resupplying the maneuver element with food, water, fuel, and ammunition. Using an "add-in" simulation package the plannin...

  5. Requirements for a Software Maintenance Methodology

    OpenAIRE

    Nance, Richard E.; Arthur, James D.; Ciaramella, John A.

    1991-01-01

    This project ventures into the domain of software maintenance methodologies, an area given relatively little attention in software engineering. Project efforts are divided into three tasks: (1) definition of maintenance methodology requirements; (2) development of a model of the AEGIS maintenance process; and (3) specification of the requirements for an AEGIS maintenance methodology. The focus of this report is on the third task. The research utilizes the Objectives/Principles/Attributes (O...

  6. Hanford analytical services quality assurance requirements documents

    Energy Technology Data Exchange (ETDEWEB)

    Hyatt, J.E.

    1997-09-25

    Hanford Analytical Services Quality Assurance Requirements Document (HASQARD) is issued by the Analytical Services, Program of the Waste Management Division, US Department of Energy (US DOE), Richland Operations Office (DOE-RL). The HASQARD establishes quality requirements in response to DOE Order 5700.6C (DOE 1991b). The HASQARD is designed to meet the needs of DOE-RL for maintaining a consistent level of quality for sampling and field and laboratory analytical services provided by contractor and commercial field and laboratory analytical operations. The HASQARD serves as the quality basis for all sampling and field/laboratory analytical services provided to DOE-RL through the Analytical Services Program of the Waste Management Division in support of Hanford Site environmental cleanup efforts. This includes work performed by contractor and commercial laboratories and covers radiological and nonradiological analyses. The HASQARD applies to field sampling, field analysis, and research and development activities that support work conducted under the Hanford Federal Facility Agreement and Consent Order Tri-Party Agreement and regulatory permit applications and applicable permit requirements described in subsections of this volume. The HASQARD applies to work done to support process chemistry analysis (e.g., ongoing site waste treatment and characterization operations) and research and development projects related to Hanford Site environmental cleanup activities. This ensures a uniform quality umbrella to analytical site activities predicated on the concepts contained in the HASQARD. Using HASQARD will ensure data of known quality and technical defensibility of the methods used to obtain that data. The HASQARD is made up of four volumes: Volume 1, Administrative Requirements; Volume 2, Sampling Technical Requirements; Volume 3, Field Analytical Technical Requirements; and Volume 4, Laboratory Technical Requirements. Volume 1 describes the administrative requirements

  7. Comparison of energy performance requirements levels

    DEFF Research Database (Denmark)

    Spiekman, Marleen; Thomsen, Kirsten Engelund; Rose, Jørgen;

    This summary report provides a synthesis of the work within the EU SAVE project ASIEPI on developing a method to compare the energy performance (EP) requirement levels among the countries of Europe. Comparing EP requirement levels constitutes a major challenge. From the comparison of for instance...... of all other project material related to that topic, which allows to easily identify the most pertinent information. Part C lists the project partners and sponsors....

  8. Forces required to vertically uproot tree stumps

    OpenAIRE

    Lindroos, Ola; Henningsson, Marina; Athanassiadis, Dimitris; Nordfjell, Tomas

    2010-01-01

    Stumpwood attracts renewed interest due to increased use of forest biomass for bioenergy. In Nordic countries stumps are generally uprooted with crawler excavators, which have strong cranes (ca. 400 kNm gross lift torque), but are not designed for moving in forest terrain. Their use is based on practical experience with available and tested machine types rather than thorough examinations of requirements, partly due to limited knowledge of force requirements for uprooting of stumps. Therefore,...

  9. Power requirements for commercial communications spacecraft

    Science.gov (United States)

    Billerbeck, W. J.

    1985-01-01

    Historical data on commercial spacecraft power systems are presented and their power requirements to the growth of satellite communications channel usage are related. Some approaches for estimating future power requirements of this class of spacecraft through the year 2000 are proposed. The key technology drivers in satellite power systems are addressed. Several technological trends in such systems are described, focusing on the most useful areas for research and development of major subsystems, including solar arrays, energy storage, and power electronics equipment.

  10. 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.

  11. Requirements development for a patient computing system.

    Science.gov (United States)

    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, and systems over time. At Partners HealthCare System in Boston, Massachusetts, we have applied a more formal approach for requirements development to the Patient Computing Project. The goal of the project is to create web-based software that connects patients electronically with their physician's offices and has the potential to improve care efficiency and quality. It is a large project, with over 500 function points. Like most technological innovation, the successful introduction of this system requires as much attention to understanding the business needs and workflow details as it does to technical design and implementation. This paper describes our RDP approach, and key business requirements discovered through this process. We believe that a formal RDP is essential, and that informatics as a field must include proficiencies in this area. PMID:11825282

  12. Requirements Flowdown for Prognostics and Health Management

    Science.gov (United States)

    Goebel, Kai; Saxena, Abhinav; Roychoudhury, Indranil; Celaya, Jose R.; Saha, Bhaskar; Saha, Sankalita

    2012-01-01

    Prognostics and Health Management (PHM) principles have considerable promise to change the game of lifecycle cost of engineering systems at high safety levels by providing a reliable estimate of future system states. This estimate is a key for planning and decision making in an operational setting. While technology solutions have made considerable advances, the tie-in into the systems engineering process is lagging behind, which delays fielding of PHM-enabled systems. The derivation of specifications from high level requirements for algorithm performance to ensure quality predictions is not well developed. From an engineering perspective some key parameters driving the requirements for prognostics performance include: (1) maximum allowable Probability of Failure (PoF) of the prognostic system to bound the risk of losing an asset, (2) tolerable limits on proactive maintenance to minimize missed opportunity of asset usage, (3) lead time to specify the amount of advanced warning needed for actionable decisions, and (4) required confidence to specify when prognosis is sufficiently good to be used. This paper takes a systems engineering view towards the requirements specification process and presents a method for the flowdown process. A case study based on an electric Unmanned Aerial Vehicle (e-UAV) scenario demonstrates how top level requirements for performance, cost, and safety flow down to the health management level and specify quantitative requirements for prognostic algorithm performance.

  13. Information System Requirements Determination: Factors Impeding Stakeholders from Reaching Common Understandings and Agreements on Requirements

    Science.gov (United States)

    Gissel, Richard L.

    2010-01-01

    Information system implementations require developers to first know what they must create and then determine how best to create it. The requirements determination phase of the system development life cycle typically determines what functions a system must perform and how well it must accomplish required functions. Implementation success depends on…

  14. From requirements to Java in a snap model-driven requirements engineering in practice

    CERN Document Server

    Smialek, Michal

    2015-01-01

    This book provides a coherent methodology for Model-Driven Requirements Engineering which stresses the systematic treatment of requirements within the realm of modelling and model transformations. The underlying basic assumption is that detailed requirements models are used as first-class artefacts playing a direct role in constructing software. To this end, the book presents the Requirements Specification Language (RSL) that allows precision and formality, which eventually permits automation of the process of turning requirements into a working system by applying model transformations and co

  15. Protein and Amino Acid Requirements during Pregnancy.

    Science.gov (United States)

    Elango, Rajavel; Ball, Ronald O

    2016-07-01

    Protein forms an essential component of a healthy diet in humans to support both growth and maintenance. During pregnancy, an exceptional stage of life defined by rapid growth and development, adequate dietary protein is crucial to ensure a healthy outcome. Protein deposition in maternal and fetal tissues increases throughout pregnancy, with most occurring during the third trimester. Dietary protein intake recommendations are based on factorial estimates because the traditional method of determining protein requirements, nitrogen balance, is invasive and undesirable during pregnancy. The current Estimated Average Requirement and RDA recommendations of 0.88 and 1.1 g · kg(-1) · d(-1), respectively, are for all stages of pregnancy. The single recommendation does not take into account the changing needs during different stages of pregnancy. Recently, with the use of the minimally invasive indicator amino acid oxidation method, we defined the requirements to be, on average, 1.2 and 1.52 g · kg(-1) · d(-1) during early (∼16 wk) and late (∼36 wk) stages of pregnancy, respectively. Although the requirements are substantially higher than current recommendations, our values are ∼14-18% of total energy and fit within the Acceptable Macronutrient Distribution Range. Using swine as an animal model we showed that the requirements for several indispensable amino acids increase dramatically during late gestation compared with early gestation. Additional studies should be conducted during pregnancy to confirm the newly determined protein requirements and to determine the indispensable amino acid requirements during pregnancy in humans. PMID:27422521

  16. The Supreme Court upholds parental notice requirements.

    Science.gov (United States)

    1990-01-01

    On June 25, 1990 the US Supreme Court ruled in 2 cases concerned with the constitutionally of 2 state law that required parental notification of minors seeking an abortion. In Hodgson v Minnesota the Court ruled that states may not require 2 parent notification. They can however require that both biological parents be notified if a judicial bypass is provided for minors wishing to keep the matter private. In Ohio v. Akron Center for Reproductive Health the Court upheld a 1 parent notification law which included a judicial bypass clause. The Court however did refuse to decide whether the state must provide the bypass option it is mandates 1 parent notification. In the Hodgson case the courts opinion stated that the state did not have the right to require that family members talk to each other. Also the Court upheld that states may require a 48-hour waiting period between notification and the procedure to give parents time to provide medical records and to check the doctor's competency. In Ohio the court ruled that states do not have to guarantee absolute anonymity of the minor as long as they make a reasonable effort to keep her name from beginning public. The Court also ruled that states can require a minor to provide "clear and compelling" evidence, the most difficult legal standard of proof, when she is petitioning the court that she is sufficiently mature to consent to the procedure or that parental notification is not in her best interest. Also, the Court ruled that the state may require doctors to notify the parents personally concerning the procedure.

  17. Getting Grip on Security Requirements Elicitation by Structuring and Reusing Security Requirements Sources

    Directory of Open Access Journals (Sweden)

    Christian Schmitt

    2015-07-01

    Full Text Available This paper presents a model for structuring and reusing security requirements sources. The model serves as blueprint for the development of an organization-specific repository, which provides relevant security requirements sources, such as security information and knowledge sources and relevant compliance obligations, in a structured and reusable form. The resulting repository is intended to be used by development teams during the elicitation and analysis of security requirements with the goal to understand the security problem space, incorporate all relevant requirements sources, and to avoid unnecessary effort for identifying, understanding, and correlating applicable security requirements sources on a project-wise basis. We start with an overview and categorization of important security requirements sources, followed by the description of the generic model. To demonstrate the applicability and benefits of the model, the instantiation approach and details of the resulting repository of security requirements sources are presented.

  18. Writing requirements across nursing programs in Canada.

    Science.gov (United States)

    Andre, Jo-Anne D; Graves, Roger

    2013-02-01

    The emphasis on scholarship in nursing, demands for evidence-based practice, and attention to writing have raised the profile of academic writing within nursing curricula. This article provides a comprehensive review of English and writing course requirements across 81 English-language baccalaureate nursing programs in Canada. The data were gathered from a review of nursing programs and curriculum information from university and college Web sites. Of the 81 programs, 39 (48.1%) require neither an English literature course nor a writing course, 15 (18.5%) require an English literature course, and 32 (39.5%) require a writing course, including five programs that require a discipline-specific writing course. Discipline-specific writing courses appear to be useful adjuncts to writing-across-the-curriculum initiatives in nursing and will help students to develop the research and writing skills needed to succeed both academically and in a career in which nursing scholarship and evidence-informed practice are increasingly valued and expected.

  19. Writing requirements across nursing programs in Canada.

    Science.gov (United States)

    Andre, Jo-Anne D; Graves, Roger

    2013-02-01

    The emphasis on scholarship in nursing, demands for evidence-based practice, and attention to writing have raised the profile of academic writing within nursing curricula. This article provides a comprehensive review of English and writing course requirements across 81 English-language baccalaureate nursing programs in Canada. The data were gathered from a review of nursing programs and curriculum information from university and college Web sites. Of the 81 programs, 39 (48.1%) require neither an English literature course nor a writing course, 15 (18.5%) require an English literature course, and 32 (39.5%) require a writing course, including five programs that require a discipline-specific writing course. Discipline-specific writing courses appear to be useful adjuncts to writing-across-the-curriculum initiatives in nursing and will help students to develop the research and writing skills needed to succeed both academically and in a career in which nursing scholarship and evidence-informed practice are increasingly valued and expected. PMID:23316890

  20. Household energy requirement and value patterns

    International Nuclear Information System (INIS)

    For an effective consumer energy policy, it is important to know why some households require more energy than others. The aim of the study described here was to examine whether there is a relationship between the total household energy requirement, on one hand, and value patterns, the motivation to save energy or the problem perception of climate change, on the other. To examine these relationships, we held a consumer survey among 2304 respondent households. We did not find significant differences in the energy requirement of groups of households with different value patterns, taking into account the differences in the socio-economic situation of households. Only for the 'motivation to save energy' we did find that the least motivated group requires 10 GJ more energy than the average and most motivated groups; this is about 4% of the total household energy requirement. This means that a self-regulating energy policy, solely based on the fact that a strategy of internalising environmental responsibility will not be effective in saving energy. There are indications that a social dilemma is one of the reasons why people's consumption patterns do not conform to their value patterns, problem perception or motivation to save energy