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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.

  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. Postmarketing surveillance for drug abuse.

    Science.gov (United States)

    Arfken, Cynthia L; Cicero, Theodore J

    2003-06-05

    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.

  5. 76 FR 47211 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements...

    Science.gov (United States)

    2011-08-04

    ..., clinical efficacy, clinical pharmacology, and nonclinical toxicology study/clinical trial either required... consolidation of certain therapeutic products formerly regulated by CBER into CDER. Consequently, CDER...

  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. Gardasil® and Cervarix® | NCI Technology Transfer Center | TTC

    Science.gov (United States)

    Vaccine for human papilloma virus (HPV) to protect from cancers Key elements of the technology for Gardasil® and Cervarix originated from the HPV research of the laboratory of Drs. Douglas Lowy and John Schiller of the NCI.

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

    DEFF Research Database (Denmark)

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

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Ross JS

    2015-05-01

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

  12. 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.

  13. Postmarket Drug Safety Information for Patients and Providers

    Science.gov (United States)

    ... Drug Safety Information for Patients and Providers Postmarket Drug Safety Information for Patients and Providers Share Tweet Linkedin Pin ... 2007 (FDAAA), this website contains links to postmarket drug safety information to improve transparency and communication to patients and ...

  14. 中药上市后临床再评价及Ⅳ期临床试验的基本要求%Basic requirements on post-marketing clinical re-evaluation of Chinese medicine and phase Ⅳ clinical trials

    Institute of Scientific and Technical Information of China (English)

    谢雁鸣; 王燕平; 田峰; 王永炎

    2011-01-01

    As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.%鉴于药品上市前临床试验获得的药品安全性和有效性数据的局限性,开展中药上市后临床再评价是非常必要的.该文讨论中药上市后临床再评价与Ⅳ期临床试验的共同点与区别;根据国内外相关法规,结合专家建议,提出中药上市后临床再评价的基本要求和建议;讨论Ⅳ期临床试验在适应证范围、设计方法、病例入选和排除标准、样本含量等方面的具体要求.

  15. Monitoring product safety in the postmarketing environment

    OpenAIRE

    Sharrar, Robert G; Dieck, Gretchen S

    2013-01-01

    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 dispr...

  16. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Science.gov (United States)

    2010-04-01

    ... derived from commercial marketing experience, postmarketing clinical investigations, postmarketing... literature, and from foreign marketing experience. (d) Scientific literature. (1) A 15-day Alert report based... Privacy Act System 09-20-0136, “Epidemiologic Studies and Surveillance of Disease Problems.”...

  17. 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.

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

    OpenAIRE

    Ross JS; Blount KL; Ritchie JD; Hodshon B; Krumholz HM

    2015-01-01

    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 po...

  19. 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.

  20. 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.

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

    Science.gov (United States)

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

    2015-06-01

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

  2. Closing the information gap: informing better medical decisionmaking through the use of post-market safety and comparative effectiveness information.

    Science.gov (United States)

    Fox, Bethany

    2012-01-01

    While FDA gathers vast amounts of data about prescription drugs prior to their marketing approval, important information about the relative effectiveness and long term safety of products is not required for approval, and often is never collected. Increased postmarket research on the safety and comparative effectiveness of products would improve medical decisionmaking and lead to better clinical outcomes. Fortunately, Congress has recognized the value of this information for healthcare professionals. In response to a congressional mandate in the FDA Amendments Act (FDAAA), FDA is developing the Sentinel Initiative, an active surveillance system for monitoring postmarket drug safety issues. FDAAA also authorized FDA to require a drug sponsor to conduct postmarket safety studies or clinical trials to address a specific safety concern. To increase the repository of comparative effectiveness information, Congress established the Patient-Centered Outcomes Research Institute (PCORI) in the Patient Protection and Affordable Care Act (PPACA), directing it to manage comparative effectiveness research (CER). This article discusses the need for better safety and comparative effectiveness information and outlines methods to efficiently conduct the research and communicate it effectively to healthcare professionals. Coordination between FDA and the PCORI in gathering and communicating postmarket information is recommended. Medical source data collected by the Sentinel Initiative should be used for CER in addition to postmarket safety surveillance, and FDA and the PCORI should adopt identical standards for the distribution and communication of CER. Coordination between the two entities is recommended to save costs, reduce duplication of efforts, and to generate and communicate more information on prescription drugs for medical decisionmakers.

  3. 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

  4. 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.

  5. 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 §...

  6. 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...

  7. 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。

  8. 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

  9. 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.

  10. 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.

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

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2010-06-01

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

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

    DEFF Research Database (Denmark)

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

    2014-01-01

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

  13. 76 FR 23825 - Study Methodologies for Diagnostics in the Postmarket Setting; Public Workshop

    Science.gov (United States)

    2011-04-28

    ... HUMAN SERVICES Food and Drug Administration Study Methodologies for Diagnostics in the Postmarket... Diagnostics in the Postmarket Setting.'' The purpose of the public workshop is to provide a forum for... epidemiology, statistics, diagnostics, and biomedical research to advance the methodologies for diagnostics...

  14. 21 CFR 601.70 - Annual progress reports of postmarketing studies.

    Science.gov (United States)

    2010-04-01

    ... provide useful information. Each annual progress report shall be accompanied by a completed transmittal... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Annual progress reports of postmarketing studies... SERVICES (CONTINUED) BIOLOGICS LICENSING Postmarketing Studies § 601.70 Annual progress reports...

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

    NARCIS (Netherlands)

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

    2016-01-01

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

  16. 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.

  17. [Technical specifications for post-marketing pharmacoeconomic evaluation of Chinese medicine (draft version for comments)].

    Science.gov (United States)

    Xie, Yan-Ming; Wang, Xin; Wang, Nuo; Chang, Yan-Peng

    2013-09-01

    Pharmacoeconomics is an important part of the post-marketing evaluation of Chinese medicine, post-marketing pharmacoeconomic evaluation can better reflect the clinical and market value of Chinese medicine, the purpose of establishing the technical specifications for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines more scientific and fair. Every country's technical specifications for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the technical specifications which take into account the special characteristics of Chinese medicine; these are in preparation for post-marketing pharmacoeconomic evaluation Chinese medicine.

  18. 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

  19. Drug- and herb-induced liver injury: Progress, currentchallenges and emerging signals of post-marketing risk

    Institute of Scientific and Technical Information of China (English)

    2015-01-01

    Drug-induced liver injury (DILI) and herb-inducedliver injury is a hot topic for clinicians, academia, drugcompanies and regulators, as shown by the steadilyincreasing number of publications in the past 15 years.This review will first provide clues for clinicians tosuspect idiosyncratic (unpredictable) DILI and succeedin diagnosis. Causality assessment remains challengingand requires careful medical history as well as awarenessof multifaceted aspects, especially for herbs.Drug discontinuation and therapy reconciliation remainthe mainstay in patent's management to minimizeoccurrence of acute liver failure. The second section willaddress novel agents associated with liver injury in 2014(referred to as "signals"), especially in terms of clinical,research and drug development implications. Insightswill be provided into recent trends by highlighting thecontribution of different post-marketing data, especiallyregistries and spontaneous reporting systems. Thisliterature scrutiny suggests (1) the importance of postmarketingdatabases as tools of clinical evidence todetect signals of DILI risk; and (2) the need for joiningefforts in improving predictivity of pre-clinical assays,continuing post-marketing surveillance and design adhoc post-authorization safety studies. In this context,ongoing European/United States research consortia andnovel pharmaco-epidemiological tools (e.g. , specialistprescription event monitoring) will support innovation inthis field. Direct oral anticoagulants and herbal/dietarysupplements appear as key research priorities.

  20. A pre-marketing ALT signal predicts post-marketing liver safety.

    Science.gov (United States)

    Moylan, Cynthia A; Suzuki, Ayako; Papay, Julie I; Yuen, Nancy A; Ames, Michael; Hunt, Christine M

    2012-08-01

    Drug induced liver injury during drug development is evidenced by a higher incidence of serum alanine aminotransferase (ALT) elevations in treated versus placebo populations and termed an "ALT signal". We sought to quantify whether an ALT signal in pre-marketing clinical trials predicted post-marketing hepatotoxicity. Incidence of ALT elevations (ALT ≥ 3 times upper limits normal [× ULN]) for drug and placebo of new chemical entities and approved drugs associated with hepatotoxicity was calculated using the Food and Drug Administration (FDA) website. Post-marketing liver safety events were identified using the FDA Adverse Event Reporting System (AERS). The association of FDA AERS signal score (EB05 ≥ 2) and excess risk of pre-marketing ALT elevation (difference in incidence of ALT ≥ 3× ULN in treated versus placebo) was examined. An ALT signal of ≥ 1.2% was significantly associated with a post-marketing liver safety signal (p ≤ 0.013) and a 71.4% positive predictive value. An absent ALT signal was associated with a high likelihood of post-marketing liver safety; negative predictive value of 89.7%. Daily drug dose information improved the prediction of post-marketing liver safety. A cut-off of 1.2% increase in ALT ≥ 3× ULN in treated versus placebo groups provides an easily calculated method for predicting post-marketing liver safety.

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

    Directory of Open Access Journals (Sweden)

    Oxana Skoková Habuštová

    2017-03-01

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

  2. Postmarketing surveillance of new food ingredients: results from the program with the fat replacer olestra.

    Science.gov (United States)

    Allgood, G S; Kuter, D J; Roll, K T; Taylor, S L; Zorich, N L

    2001-04-01

    Market introduction of savory snacks containing olestra offered an opportunity to evaluate the safety of olestra in a free-living population and thereby compare the outcome to the previously established safety profile determined in clinical trials in which subjects were required to eat predetermined amounts at prescribed intervals. Therefore, a multifaceted postmarketing surveillance program was designed to evaluate consumer experience and safety of olestra in the marketplace. Customer comments were solicited through toll-free telephone numbers. Collected data were evaluated by both internal and external medical experts. About 10% of toll-free telephone calls reported health effects, most of which were gastrointestinal (GI) in nature. Clinical studies were designed and conducted to determine potential GI effects under the range of consumption patterns reported by toll-free calls. Health effects reported were those found commonly in the general population and analyses of the data found no biological reason to conclude that serious or meaningful health effects were the result of olestra consumption.

  3. 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...

  4. 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...

  5. [Thought on several problems of post-marketing herbs clinical evaluation in special populations].

    Science.gov (United States)

    Zhou, Ai; Lian, Fengmei

    2011-10-01

    The re-evaluation of clinical post-marketing herbs in special populations, such as children, the aged, pregnant women, lactating women, has attracted attention in our country. The media is drug adverse reaction reports and package insert. The safety of combined administration in aged and children's growth should have been taken long-term follow-up study. Perfecting traditional chinese medicine FDA system will be beneficial to the re-evaluation of clinical postmarketing herbs in pregnant women. Dose-effect study in children also should cause the concern of researchers.

  6. Human Papillomavirus (HPV) Vaccine (Cervarix)

    Science.gov (United States)

    ... symptoms, and go away on their own. But HPV can cause cervical cancer in women. Cervical cancer is the 2nd leading ... vaccine you are getting is one of two HPV vaccines that can be given to prevent cervical cancer. It is given to females only.The other ...

  7. Food and Drug Administration (FDA) postmarket reported side effects and adverse events associated with pulmonary hypertension therapy in pediatric patients.

    Science.gov (United States)

    Maxey, Dawn M; Ivy, D Dunbar; Ogawa, Michelle T; Feinstein, Jeffrey A

    2013-10-01

    Because most medications for pediatric pulmonary hypertension (PH) are used off label and based on adult trials, little information is available on pediatric-specific adverse events (AEs). Although drug manufacturers are required to submit postmarket AE reports to the Food and Drug Administration (FDA), this information is rarely transmitted to practitioners. In the setting of a recent FDA warning for sildenafil, the authors sought to give a better description of the AEs associated with current therapies in pediatric PH. In January 2010, a written request was made to the Food and Drug Administration for AE records of commonly used PH medications. Reports were screened for pediatric patients, analyzed in terms of AEs, and compared with the medical literature. Arbitrarily, AEs that could be attributed to concomitant medications were not attributed to the PH medication in question. Adverse events occurring in more than 5 % of events for each drug were assumed to be associated with the targeted PH medication. Between November 1997 and December 2009, 588 pediatric AE reports (death in 257 cases) were reported for the three most commonly used therapies: bosentan, epoprostenol, and sildenafil. Many of the AEs were similar to those reported previously. However, 27 AEs not previously reported in the literature (e.g., pulmonary hemorrhage, hemoptysis, and pneumonia) were found. The FDA postmarket records for PH medications in pediatric patients show a significant number of AEs. The discovery of AEs not previously reported will better inform those caring for these complex and critically ill children, and the large number of deaths suggest they may be underreported in current literature.

  8. ADVERSE REACTIONS ATTRIBUTED TO SUMATRIPTAN - A POSTMARKETING STUDY IN GENERAL-PRACTICE

    NARCIS (Netherlands)

    OTTERVANGER, JP; VANWITSEN, TB; VALKENBURG, HA; GROBBEE, DE; STRICKER, BHC

    1994-01-01

    There are several reports on cardiac adverse reactions attributed to the antimigraine drug sumatriptan in the recent literature. In order to assess the frequency and the character of adverse reactions to sumatriptan, a postmarketing cohort study was performed one year after registration of the drug

  9. [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.

  10. 77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...

    Science.gov (United States)

    2012-08-30

    ... each presenter and the approximate time each oral presentation is to begin and will notify participants by September 4, 2012. All requests to make oral presentations must be received by August 31, 2012... Postmarket Surveillance System.'' The purpose of the meeting is to solicit public feedback regarding...

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

    Science.gov (United States)

    Liu, Huan; Xie, Yanming

    2011-10-01

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

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

    Science.gov (United States)

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

    2014-09-01

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

  13. 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

  14. Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study.

    Science.gov (United States)

    Botelho, Stephanie Ferreira; Martins, Maria Auxiliadora Parreiras; Vieira, Liliana Batista; Reis, Adriano Max Moreira

    2016-08-29

    This study investigated postmarketing safety events (PMSEs) for new drugs approved in Brazil and evaluated whether a range of drug characteristics influenced the time between approval and the first PMSE. This retrospective study included new drugs registered between 2003 and 2013 by the National Health Surveillance Agency (ANVISA), which is responsible for medicines approval in Brazil. PMSEs were defined as any drug safety alert or drug withdrawal from the market. The existence of risk evaluation and mitigation strategies (REMS) by the US Food and Drug Administration (FDA) and Brazil were recorded. A Kaplan-Meier survival curve of the period between the date of ANVISA registration and the PMSE was calculated. We found a statistically significant difference between the time to PMSE for drugs with an FDA REMS compared with those without a REMS, with a log rank value (Mantel Cox) of 0.002. There was no association between the time to PMSE and the other drug characteristics investigated. This study demonstrated that the frequency of PMSEs for new drugs approved by ANVISA was statistically associated with the existence of an FDA REMS. The time between approval and first PMSE was shorter for drugs with an FDA REMS, and this finding may contribute to improved awareness of the risk/benefit balance required to ensure continued safe and effective use of new drugs.

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

    Science.gov (United States)

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

    2013-11-01

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

  16. [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.

  17. 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.

  18. 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

  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...... 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...

  20. 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.

  1. 75 FR 68802 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements...

    Science.gov (United States)

    2010-11-09

    ... clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology study/clinical trial... therapeutic products formerly regulated by CBER into CDER. Consequently, CDER now reviews many BLAs....

  2. 77 FR 13339 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements...

    Science.gov (United States)

    2012-03-06

    ... clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology study/clinical trial... completed a consolidation of certain therapeutic products formerly regulated by CBER into CDER....

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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...

  8. Developments in post-marketing comparative effectiveness research.

    Science.gov (United States)

    Schneeweiss, S

    2007-08-01

    Physicians and insurers need to weigh the effectiveness of new drugs against existing therapeutics in routine care to make decisions about treatment and formularies. Because Food and Drug Administration (FDA) approval of most new drugs requires demonstrating efficacy and safety against placebo, there is limited interest by manufacturers in conducting such head-to-head trials. Comparative effectiveness research seeks to provide head-to-head comparisons of treatment outcomes in routine care. Health-care utilization databases record drug use and selected health outcomes for large populations in a timely way and reflect routine care, and therefore may be the preferred data source for comparative effectiveness research. Confounding caused by selective prescribing based on indication, severity, and prognosis threatens the validity of non-randomized database studies that often have limited details on clinical information. Several recent developments may bring the field closer to acceptable validity, including approaches that exploit the concepts of proxy variables using high-dimensional propensity scores, within-patient variation of drug exposure using crossover designs, and between-provider variation in prescribing preference using instrumental variable (IV) analyses.

  9. Post-marketing access to orphan drugs: a critical analysis of health technology assessment and reimbursement decision-making considerations

    Directory of Open Access Journals (Sweden)

    Iskrov G

    2014-01-01

    Full Text Available Georgi Iskrov, Rumen Stefanov Department of Social Medicine and Public Health, Medical University of Plovdiv, Plovdiv, Bulgaria Abstract: This study aims to explore the current rationale of post-marketing access to orphan drugs. As access to orphan medicinal products depends on assessment and appraisal by health authorities, this article is focused on health technology assessment (HTA and reimbursement decision-making considerations for orphan drugs. A critical analysis may identify important factors that could predetermine the combined outcomes of these two processes. Following this objective, an analytical framework was developed, comprising three overlaying issues: to outline what is currently done and what needs to be done in the field of HTA of orphan drugs, to synthesize important variables relevant to the reimbursement decision-making about orphan drugs, and to unveil relationships between theory and practice. Methods for economic evaluation, cost-effectiveness threshold, budget impact, uncertainty of evidence, criteria in reimbursement decision-making, and HTA research agenda are all explored and discussed from an orphan drug perspective. Reimbursement decision-making for orphan drugs is a debate of policy priorities, health system specifics, and societal attitudes. Health authorities need to pursue a multidisciplinary analysis on a range of criteria, ensuring an explicit understanding of the trade-offs for decisions related to eligibility for reimbursement. The only reasonable way to accept a higher valuation of orphan drug benefits is if these are demonstrated empirically. Rarity means that the quality of orphan drug evidence is not the same as for conventional therapies. Closing this gap is another crucial point for the timely access to these products. The generation of evidence goes far beyond pre-market authorization trials and requires transnational cooperation and coordination. Early constructive dialogue among orphan drug

  10. [Research on the issues in the process of post-market surveillance for medical devices based on the typical case analysis].

    Science.gov (United States)

    Zhang, Sumin; Zhang, Liang

    2011-11-01

    Regarding the information collected, analysis and actions that have been taken, the issues in the process of the Post-market Surveillance for Medical Device were analyzed, and some suggestions were given at the same time.

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

    Science.gov (United States)

    Hauben, M; Bate, A

    2009-04-01

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

  12. 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.

  13. Post-marketing surveillance of live-attenuated Japanese encephalitis vaccine safety in China.

    Science.gov (United States)

    Wang, Yali; Dong, Duo; Cheng, Gang; Zuo, Shuyan; Liu, Dawei; Du, Xiaoxi

    2014-10-07

    Japanese encephalitis (JE) is the most severe form of viral encephalitis in Asia and no specific treatment is available. Vaccination provides an effective intervention to prevent JE. In this paper, surveillance data for adverse events following immunization (AEFI) related to SA-14-14-2 live-attenuated Japanese encephalitis vaccine (Chengdu Institute of Biological Products) was presented. This information has been routinely generated by the Chinese national surveillance system for the period 2009-2012. There were 6024 AEFI cases (estimated reported rate 96.55 per million doses). Most common symptoms of adverse events were fever, redness, induration and skin rash. There were 70 serious AEFI cases (1.12 per million doses), including 9 cases of meningoencephalitis and 4 cases of death. The post-marketing surveillance data add the evidence that the Chengdu institute live attenutated vaccine has a reasonable safety profile. The relationship between encephalitis and SA-14-14-2 vaccination should be further studied.

  14. A distributed, collaborative intelligent agent system approach for proactive postmarketing drug safety surveillance.

    Science.gov (United States)

    Ji, Yanqing; Ying, Hao; Farber, Margo S; Yen, John; Dews, Peter; Miller, Richard E; Massanari, R Michael

    2010-05-01

    Discovering unknown adverse drug reactions (ADRs) in postmarketing surveillance as early as possible is of great importance. The current approach to postmarketing surveillance primarily relies on spontaneous reporting. It is a passive surveillance system and limited by gross underreporting (computers located in different places, are capable of continuously and autonomously collaborating with each other and assisting the human users (e.g., the food and drug administration (FDA), drug safety professionals, and physicians). The agents should enhance current systems and accelerate early ADR identification. To evaluate the performance of the ADRMonitor with respect to the current spontaneous reporting approach, we conducted simulation experiments on identification of ADR signal pairs (i.e., potential links between drugs and apparent adverse reactions) under various conditions. The experiments involved over 275,000 simulated patients created on the basis of more than 1000 real patients treated by the drug cisapride that was on the market for seven years until its withdrawal by the FDA in 2000 due to serious ADRs. Healthcare professionals utilizing the spontaneous reporting approach and the ADRMonitor were separately simulated by decision-making models derived from a general cognitive decision model called fuzzy recognition-primed decision (RPD) model that we recently developed. The quantitative simulation results show that 1) the number of true ADR signal pairs detected by the ADRMonitor is 6.6 times higher than that by the spontaneous reporting strategy; 2) the ADR detection rate of the ADRMonitor agents with even moderate decision-making skills is five times higher than that of spontaneous reporting; and 3) as the number of patient cases increases, ADRs could be detected significantly earlier by the ADRMonitor.

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

    Science.gov (United States)

    Xiao, Ying; Zhao, Yubin; Xie, Yanming

    2011-10-01

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

  16. 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.)

  17. [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.

  18. 美国异维A酸上市后风险控制措施研究%Research on Isotretinoin Post-Marketing Risk Control in America

    Institute of Scientific and Technical Information of China (English)

    刘思齐; 刘文源; 杨悦

    2015-01-01

    目的:通过研究美国异维 A 酸上市后风险控制措施,以期为我国建立完善的药品上市后风险管理体系提供参考。方法通过查阅 FDA 药品上市后风险管理指南及法规,分析美国对异维 A 酸致畸和致抑郁甚至自杀风险的干预措施,并与我国采取的相关风险控制措施进行对比。结果美国实施一系列的风险管理措施,如随处方一起发放的用药指南,处方医生、患者、药房、批发商必须遵守一定的安全用药规定,定期评估风险控制效果并不断完善等,在很大程度上控制异维 A 酸使用风险。结论美国药品上市后风险管控思路和措施对我国具有一定的借鉴意义。%Objective To research isotretinoin post-marketing risk control in America, and make reference for developing sophisticated drug post -marketing risk management system in our country. Methods Drug post -marketing risk management regulation and guidance of America were looked up, the risk control measurements against teratogenesis and depression induced by isotretinoin were analyzed, and the risk control carried out by America and China were compared. Results FDA conducts a series of risk manage measures, such as medication guide dispensed with prescription, specific requirement which prescribers, patients, pharmacies and wholesalers must follow to assure safe use, evaluating the effect of risk mitigation periodically and improving accordingly, as a result, they control the risk to a large extent. Conclusion Drug post-marketing risk control concepts and designs are useful references for China.

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

    Science.gov (United States)

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

    2013-06-01

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

  20. 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.

  1. 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.

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

    Directory of Open Access Journals (Sweden)

    Shoko Takahashi

    2016-01-01

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

  3. Citicoline for acute ischemic stroke in Mexican hospitals: a retrospective postmarketing analysis.

    Science.gov (United States)

    Leon-Jimenez, C; Chiquete, E; Cantu, C; Miramontes-Saldana, M J; Andrade-Ramos, M A; Ruiz-Sandoval, J L

    2010-06-01

    Some neuroprotective agents have shown benefits in animal models, but disappointing results in humans. Citicoline is used in several countries as coadjuvant treatment in acute ischemic stroke (AIS) patients; however, there are no retrospective postmarketing surveillances on the experience of citicoline in Mexico. The aim of this study was to evaluate the correlation between citicoline exposure and functional outcome at discharge and at 30 and 90 days post-stroke, in a retrospective case-control design on systematic descriptive databases from three referral hospitals. Clinical records of 173 consecutively registered patients were analyzed, 86 of whom were treated with citicoline within the first 48 h after AIS and the remaining 87 were untreated, randomly selected controls matched for age (+/- 5 years), gender and NIHSS (+/- 1 point) at hospital admission. Pretreatment conditions were similar between groups. Compared with controls, exposure to citicoline was associated with a significantly lower 30-day mean and median modified Rankin score (in both, P citicoline was independently associated with a lower 90-day mortality risk (P = 0.047) and with fewer in-hospital complications (mainly infections and sepsis, P = 0.001). In this observational study, citicoline use was associated with a better functional status and lower rates of short-term mortality, possibly due to fewer in-hospital systemic complications. The putative benefits should be interpreted as clinical associations, since this is not a randomized, controlled clinical trial.

  4. 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.

  5. [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.

  6. Lasting treatment effects in a postmarketing surveillance study of prolonged-release melatonin.

    Science.gov (United States)

    Hajak, Göran; Lemme, Kathrin; Zisapel, Nava

    2015-01-01

    Surveillance studies are useful to evaluate how a new medicinal product performs in everyday treatment and how the patient who takes it feels and functions, thereby determining the benefit/risk ratio of the drug under real-life conditions. Prolonged-release melatonin (PRM; Circadin) was approved in Europe for the management of primary insomnia patients age 55 years or older suffering from poor quality of sleep. With traditional hypnotics (e.g. benzodiazepine-receptor agonists), there are concerns about rebound insomnia and/or withdrawal symptoms. We report data from a postmarketing surveillance study in Germany on the effects of 3 weeks of treatment with PRM on sleep in patients with insomnia during treatment and at early (1-2 days) and late (around 2 weeks) withdrawal. In total, 653 patients (597 evaluable) were recruited at 204 sites (mean age 62.7 years, 68% previously treated with hypnotics, 65% women). With PRM treatment, the mean sleep quality (on a scale of 1-5 on which 1 is very good and 5 is very bad) improved from 4.2 to 2.6 and morning alertness improved from 4.0 to 2.5. The improvements persisted over the post-treatment observation period. Rebound insomnia, defined as a one-point deterioration in sleep quality below baseline values, was found in 3.2% (early withdrawal) and 2.0% (late withdrawal). Most of the patients (77%) who used traditional hypnotics before PRM treatment had stopped using them and only 5.6% of naive patients started such drugs after PRM discontinuation. PRM was well tolerated during treatment and the most frequently reported adverse events were nausea (10 patients, 1.5%), dizziness, restlessness and headache (five patients each, insomnia.

  7. 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.

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

    Science.gov (United States)

    Sanvido, Olivier; Romeis, Jörg; Bigler, Franz

    2011-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Daniel B Kramer

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

  10. 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...

  11. A potential causal association mining algorithm for screening adverse drug reactions in postmarketing surveillance.

    Science.gov (United States)

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

    2011-05-01

    Early detection of unknown adverse drug reactions (ADRs) in postmarketing surveillance saves lives and prevents harmful consequences. We propose a novel data mining approach to signaling potential ADRs from electronic health databases. More specifically, we introduce potential causal association rules (PCARs) to represent the potential causal relationship between a drug and ICD-9 (CDC. (2010). International Classification of Diseases, Ninth Revision (ICD-9). [Online]. Available: http://www.cdc.gov/nchs/icd/icd9.html) coded signs or symptoms representing potential ADRs. Due to the infrequent nature of ADRs, the existing frequency-based data mining methods cannot effectively discover PCARs. We introduce a new interestingness measure, potential causal leverage, to quantify the degree of association of a PCAR. This measure is based on the computational, experience-based fuzzy recognition-primed decision (RPD) model that we developed previously (Y. Ji, R. M. Massanari, J. Ager, J. Yen, R. E. Miller, and H. Ying, "A fuzzy logic-based computational recognition-primed decision model," Inf. Sci., vol. 177, pp. 4338-4353, 2007) on the basis of the well-known, psychology-originated qualitative RPD model (G. A. Klein, "A recognition-primed decision making model of rapid decision making," in Decision Making in Action: Models and Methods, 1993, pp. 138-147). The potential causal leverage assesses the strength of the association of a drug-symptom pair given a collection of patient cases. To test our data mining approach, we retrieved electronic medical data for 16,206 patients treated by one or more than eight drugs of our interest at the Veterans Affairs Medical Center in Detroit between 2007 and 2009. We selected enalapril as the target drug for this ADR signal generation study. We used our algorithm to preliminarily evaluate the associations between enalapril and all the ICD-9 codes associated with it. The experimental results indicate that our approach has a potential to

  12. 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

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

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    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

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

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    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

  15. [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.

  16. Post-marketing Safety Evaluation of S-1 in Patients with Inoperable or Recurrent Breast Cancer: Especially in Patients Treated with S-1 + Trastuzumab

    OpenAIRE

    Saito, Yuki; Oshitanai, Risa; Terao, Mayako; Terada, Mizuho; Tsuda, Banri; Okamura, Takuho; Suzuki, Yasuhiro; Tokuda, Yutaka

    2011-01-01

    Objective The purpose of this study was to assess the safety of S-1 in Japanese in inoperable or recurrent breast cancer patients. Methods A prospective post-marketing surveillance was performed at 313 sites in Japan in patients with inoperable or recurrent breast cancer treated with S-1. We examined 1361 patients between January 2006 and December 2007 with regard to the incidence of adverse drug reactions graded by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Resu...

  17. 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

  18. Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

    Science.gov (United States)

    Michel, Christiane; Scosyrev, Emil; Petrin, Michael; Schmouder, Robert

    2017-02-21

    Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs. In fact, recent publications have promoted this practice, claiming to provide guidance on treatment decisions to healthcare decision makers. In this article we investigate the validity of this approach. We argue that disproportionality cannot be used for comparative drug safety analysis beyond basic hypothesis generation because measures of disproportionality are: (1) missing the incidence denominators, (2) subject to severe reporting bias, and (3) not adjusted for confounding. Hypotheses generated by disproportionality analyses must be investigated by more robust methods before they can be allowed to influence clinical decisions.

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

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    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.

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

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    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.

  1. An update on the safety and tolerability of pimecrolimus cream 1%: evidence from clinical trials and post-marketing surveillance.

    Science.gov (United States)

    Langley, Richard G B; Luger, Thomas A; Cork, Michael J; Schneider, Dirk; Paul, Carle

    2007-01-01

    In this report, we review the data on the safety and tolerability of pimecrolimus cream 1% (Elidel) from clinical trials and post-marketing surveillance in patients with atopic dermatitis. These data demonstrate that topically applied pimecrolimus is minimally absorbed through the skin and has a favourable safety margin. The most common treatment-related adverse events are transient local reactions, particularly skin burning (16.1 and 12.9 events per 1,000 patient-months of follow-up in adults and children, respectively). When compared to the vehicle, the use of pimecrolimus cream 1% is associated with an increased incidence of herpes simplex virus infections in children (relative risk: 2.5; 95% confidence interval: 1.2-5.8; p = 0.017). However, pimecrolimus cream 1% does not increase the incidence of any skin infection in comparison with moderately potent topical corticosteroids and lacks other corticosteroid-related side effects such as skin atrophy. While cases of malignancy have been reported in patients who have used pimecrolimus cream 1%, there is no clinical evidence to establish that treatment with pimecrolimus cream 1% increases the risk of malignancy.

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

    Science.gov (United States)

    Mera, Takeshi; Saijo, Nagahiro; Akaza, Hideyuki

    2012-04-01

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

  3. [Standard Cancer Therapy Are Established by the Investigator-Initiated Post-Marketing Clinical Trials, Not by the Indication-Directed Clinical Trials].

    Science.gov (United States)

    Shimada, Yasuhiro

    2016-04-01

    The financial supports for investigator-initiated post-marketing clinical trial in clinical oncology are reduced after scandals related to the other fields of clinical trials in Japan. These clinical trials are the essential final steps of clinical development in newer cancer therapy, which should be conducted in the investigator-initiated clinical trial groups with well-organized infrastructure and continuous financial supports. The present problems are discussed and summarized. Future perspectives with the national viewpoints needed to be included the idea of "health technology assessment".

  4. [Discussion about relativity between post-marketed safety outcome and treatment course of traditional Chinese medicine drugs on basis of reinforced urn processes].

    Science.gov (United States)

    Zhong, Cheng-Liang; Hu, Si-Yuan; Xie, Yan-Ming; Wang, Yong-Yan

    2013-09-01

    Based on relevant research and development, the possibility of applying the reinforced urn processes (RUPs) statistical approach to traditional Chinese medicine(TCM) drugs safety research is discussed in this paper, primarily through theoretical discussion and simulations. Also introduced are work flows and the key points for the application of the RUPs approach. This potentially new approach has recently been applied to the target estimation of phase I human tolerance clinical trials. A traditional RUPs approach has also been widely applied in the precise point-estimation of allowable longest treatment courses, according to the particular safety outcomes of post-marketed TCM.

  5. 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

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

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    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.

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

    Science.gov (United States)

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

    2017-02-26

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

  8. Moxonidine in the treatment of overweight and obese patients with the metabolic syndrome: a postmarketing surveillance study.

    Science.gov (United States)

    Sharma, A M; Wagner, T; Marsalek, P

    2004-09-01

    Moxonidine is a centrally active imidazoline receptor agonist that effectively lowers blood pressure and has been shown to have beneficial effects on lipid and carbohydrate metabolism. We assessed the efficacy of moxonidine in a postmarketing surveillance study (CAMUS) conducted in 772 practices in Germany, documenting 4005 patients with hypertension, who were overweight and/or suffered from metabolic syndrome. Patients were treated with moxonidine (Cynt) for the first time following the baseline visit for 8 weeks. Mean blood pressure decreased from 168/97 to 141/83 mmHg for all patients and from 168/96 to 141/83 mmHg for patients with metabolic syndrome. Blood pressure reduction was particularly pronounced in patients with severe hypertension at baseline. The response rate (DBP or =10 mmHg) of antihypertensive treatment with moxonidine was 94.0% for all patients and 93.8% for patients with metabolic syndrome. The recommended targets for antihypertensive treatment of the German Diabetes Society/German Hypertension Society were reached by 30.5% of nondiabetics (goal: <140/90 mmHg) and by 3.6% of diabetics (goal: <130/80 mmHg) observed. After 8 weeks of treatment, patients achieved a mean weight loss of 1.4 kg, which was particularly pronounced in obese patients. The rate of patients receiving antihypertensive combination therapy was 81.1% for those with metabolic syndrome, and 63.3% for all other patients. Patients with metabolic syndrome were preferentially treated with ACE inhibitors and diuretics. We conclude that moxonidine effectively reduces blood pressure in patients with metabolic syndrome while simultaneously reducing body weight in obese patients.

  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.

  10. Biosimilars in inflammatory bowel disease: A review of post-marketing experience.

    Science.gov (United States)

    Deiana, Simona; Gabbani, Tommaso; Annese, Vito

    2017-01-14

    Biologic compounds are obtained from living organisms or cell cultures by means of biotechnology methods. A similar biologic drug, commonly called biosimilar, is a product copied by a native approved biologic drug whose license has expired. Biosimilar drugs usually are marketed at a lower price and provide important financial savings for public healthcare systems. Some differences between biosimilars and original biologic drugs might exist but they are acceptable if they fall within defined "boundaries of tolerance": differences in some features between the two molecules are considered important only if clinical relevant. Considering that the efficacy of the innovator biologic drug has already been established, the clinical studies required for approval of a biosimilar could be reduced compared with those required for the approval of the originator. In this review, real life data available in inflammatory bowel disease patients treated with biosimilars are reported, documenting in general satisfactory outcomes, sustained efficacy and no sign of increased immunogenicity, although, further controlled data are awaited.

  11. Hepatoxicity associated with weight-loss supplements: a case for better post-marketing surveillance.

    Science.gov (United States)

    Lobb, Ano

    2009-04-14

    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. 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.

  13. [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.

  14. Measles, mumps, and rubella virus vaccine (M-M-R™II): a review of 32 years of clinical and postmarketing experience.

    Science.gov (United States)

    Lievano, Fabio; Galea, Susan A; Thornton, Michele; Wiedmann, Richard T; Manoff, Susan B; Tran, Trung N; Amin, Manisha A; Seminack, Margaret M; Vagie, Kristen A; Dana, Adrian; Plotkin, Stanley A

    2012-11-06

    M-M-R™II (measles, mumps, and rubella virus vaccine live; Merck, Sharp, & Dohme Corp.) is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals ≥ 12 months of age. Before the vaccine era, these viruses infected most exposed individuals, with subsequent morbidity and mortality. One of the greatest achievements of public health has been to eliminate these 3 diseases in large geographic areas. The safety profile of M-M-R™II is described using data from routine global postmarketing surveillance. Postmarketing surveillance has limitations (including incomplete reporting of case data), but allows collection of real-world information on large numbers of individuals, who may have concurrent medical problems excluding them from clinical trials. It can also identify rare adverse experiences (AEs). Over its 32-year history, ≈ 575 million doses of M-M-R™II have been distributed worldwide, with 17,536 AEs voluntarily reported for an overall rate of 30.5 AEs/1,000,000 doses distributed. This review provides evidence that the vaccine is safe and well-tolerated.

  15. Biosimilars in inflammatory bowel disease: A review of post-marketing experience

    Science.gov (United States)

    Deiana, Simona; Gabbani, Tommaso; Annese, Vito

    2017-01-01

    Biologic compounds are obtained from living organisms or cell cultures by means of biotechnology methods. A similar biologic drug, commonly called biosimilar, is a product copied by a native approved biologic drug whose license has expired. Biosimilar drugs usually are marketed at a lower price and provide important financial savings for public healthcare systems. Some differences between biosimilars and original biologic drugs might exist but they are acceptable if they fall within defined “boundaries of tolerance”: differences in some features between the two molecules are considered important only if clinical relevant. Considering that the efficacy of the innovator biologic drug has already been established, the clinical studies required for approval of a biosimilar could be reduced compared with those required for the approval of the originator. In this review, real life data available in inflammatory bowel disease patients treated with biosimilars are reported, documenting in general satisfactory outcomes, sustained efficacy and no sign of increased immunogenicity, although, further controlled data are awaited. PMID:28127193

  16. [A perspective for the role of drug registries in the post-marketing surveillance].

    Science.gov (United States)

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

    2013-06-01

    Drug registries are implemented after the authorization of new products and represent a tool for systematic collection of data aimed at obtaining additional knowledge on appropriateness, effectiveness and safety. The design of registries needs to be coherent with the main objective and a study protocol is required before the implementation. A registry aimed at the appropriateness of drug use should be primarily considered for high cost drugs when there is a risk, either for the patients' safety or for public expenditure, in using the drug outside the approved indications. Since the registry is a condition for the access to drugs, and all users are included, an extremely simplified data collection is required. However, the data should be available at regional level to allow record linkage procedures with other databases for conducting outcome studies. When registries are aimed at acquiring new information on the risk profile, the duration and the regional extension of data collection should be coherent with the expected incidence of events of interest. A great attention should be devoted in preventing that patients are lost to follow-up, since the reasons for being lost are frequently associated with harmful outcomes, such as adverse drug reactions. In a registry focused on effectiveness, the main aim consists in ascertaining the reasons (the prognostic factors), for possible discrepancies between premarketing studies and clinical practice. Taking into account the greater incidence of the expected events, there are fewer reasons for extending data collection to all users, whereas the main attention should focus on quality controls and the ascertainment of confounding factors. Given the relevance of the validity issues, in the set out of a registry it is important to think about ad hoc resources and the adequacy of infrastructures. As for any epidemiological study, an adequate qualification of the researcher/clinician in charge of conducting a registry should be

  17. 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

  18. 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.

  19. 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...

  20. 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.

  1. 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

  2. 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.

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

    Science.gov (United States)

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

    2014-08-01

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

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

    Directory of Open Access Journals (Sweden)

    Miller LE

    2013-05-01

    Full Text Available Larry E Miller,1,2 W Carlton Reckling,3 Jon E Block21Miller Scientific Consulting Inc, Arden, NC, 2The Jon Block Group, San Francisco, CA, 3SI-BONE Inc, San Jose, CA, USABackground: The sacroiliac joint is a common but under-recognized source of low back and gluteal pain. Patients with degenerative sacroiliitis or sacroiliac joint disruption resistant to nonsurgical treatments may undergo open surgery with sacroiliac joint arthrodesis, although outcomes are mixed and risks are significant. Minimally invasive sacroiliac joint arthrodesis was developed to minimize the risk of iatrogenic injury and to improve patient outcomes compared with open surgery.Methods: Between April 2009 and January 2013, 5319 patients were treated with the iFuse SI Joint Fusion System® for conditions including sacroiliac joint disruption and degenerative sacroiliitis. A database was prospectively developed to record all complaints reported to the manufacturer in patients treated with the iFuse device. Complaints were collected through spontaneous reporting mechanisms in support of ongoing mandatory postmarket surveillance efforts.Results: Complaints were reported in 204 (3.8% patients treated with the iFuse system. Pain was the most commonly reported clinical complaint (n = 119, 2.2%, with nerve impingement (n = 48, 0.9% and recurrent sacroiliac joint pain (n = 43, 0.8% most frequently cited. All other clinical complaints were rare (≤0.2%. Ninety-six revision surgeries were performed in 94 (1.8% patients at a median follow-up of four (range 0–30 months. Revisions were typically performed in the early postoperative period for treatment of a symptomatic malpositioned implant (n = 46, 0.9% or to correct an improperly sized implant in an asymptomatic patient (n = 10, 0.2%. Revisions in the late postoperative period were performed to treat symptom recurrence (n = 34, 0.6% or for continued pain of undetermined etiology (n = 6, 0.1%.Conclusion: Analysis of a postmarket

  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.

  6. 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.

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

    Science.gov (United States)

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

    2015-11-17

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

  8. 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

    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......-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...... and number of previous DMARDs declined significantly during the three years, e.g. baseline DAS28 decreased from 5.6 to 5.1 in both Denmark (pp=0.004). 47.9 and 41.3% of the Norwegian and Danish patients, respectively, did not meet the UK-criteria for using TNF- blocking agents, and 10...

  9. Real-life versus package insert: a post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers.

    Science.gov (United States)

    Hatz, Christoph; Beck, Bernhard; Steffen, Robert; Genton, Blaise; d'Acremont, Valérie; Loutan, Louis; Hartmann, Katharina; Herzog, Christian

    2011-07-12

    There are various methods to collect adverse events (AEs) in clinical trials. The methods how AEs are collected in vaccine trials is of special interest: solicited reporting can lead to over-reporting events that have little or no biological relationship to the vaccine. We assessed the rate of AEs listed in the package insert for the virosomal hepatitis A vaccine Epaxal(®), comparing data collected by solicited or unsolicited self-reporting. In an open, multi-centre post-marketing study, 2675 healthy travellers received single doses of vaccine administered intramuscularly. AEs were recorded based on solicited and unsolicited questioning during a four-day period after vaccination. A total of 2541 questionnaires could be evaluated (95.0% return rate). Solicited self-reporting resulted in significantly higher (p<0.0001) rates of subjects with AEs than unsolicited reporting, both at baseline (18.9% solicited versus 2.1% unsolicited systemic AEs) and following immunization (29.6% versus 19.3% local AEs; 33.8% versus 18.2% systemic AEs). This could indicate that actual reporting rates of AEs with Epaxal(®) may be substantially lower than described in the package insert. The distribution of AEs differed significantly between the applied methods of collecting AEs. The most common AEs listed in the package insert were reported almost exclusively with solicited questioning. The reporting of local AEs was more likely than that of systemic AEs to be influenced by subjects' sex, age and study centre. Women reported higher rates of AEs than men. The results highlight the need for detailing the methods how vaccine tolerability was reported and assessed.

  10. Confirmation of in vitro and clinical safety assessment of behentrimonium chloride-containing leave-on body lotions using post-marketing adverse event data.

    Science.gov (United States)

    Cameron, D M; Donahue, D A; Costin, G-E; Kaufman, L E; Avalos, J; Downey, M E; Billhimer, W L; Gilpin, S; Wilt, N; Simion, F A

    2013-12-01

    Behentrimonium chloride (BTC) is a straight-chain alkyltrimonium chloride compound commonly used as an antistatic, hair conditioning, emulsifier, or preservative agent in personal care products. Although the European Union recently restricted the use of alkyltrimonium chlorides and bromides as preservatives to ≤0.1%, these compounds have been safely used for many years at ≤5% in hundreds of cosmetic products for other uses than as a preservative. In vitro, clinical, and controlled consumer usage tests in barrier-impaired individuals were conducted to determine if whole body, leave-on skin care products containing 1-5% BTC cause dermal irritation or any other skin reaction with use. BTC-containing formulations were predicted to be non-irritants by the EpiDerm® skin irritation test and the bovine corneal opacity and permeability (BCOP)/chorioallantoic membrane vascular assay (CAMVA) ocular irritation test battery. No evidence of allergic contact dermatitis or cumulative dermal irritation was noted under the exaggerated conditions of human occlusive patch tests. No clinically assessed or self-reported adverse reactions were noted in adults or children with atopic, eczematous, and/or xerotic skin during two-week and four-week monitored home usage studies. These results were confirmed by post-marketing data for five body lotions, which showed only 0.69 undesirable effects (mostly skin irritation) reported per million shipped consumer units during 2006-2011; a value consistent with a non-irritating body lotion. No serious undesirable effects were reported during in-market use of the products. Therefore, if formulated in appropriate conditions at 1-5%, BTC will not cause dermal irritation or delayed contact sensitization when used in a whole-body, leave-on product.

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

    Science.gov (United States)

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

    2014-04-01

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

  12. 参麦注射液上市后再评价系列研究%Series of Studies on Post-marketing Evaluation of Shenmai Injection

    Institute of Scientific and Technical Information of China (English)

    王连心; 谢雁鸣; 艾青华; 姜俊杰

    2014-01-01

    Shenmai injection is commonly used for treatment of shock,coronary heart disease,viral myocarditis,chronic pulmonary heart disease and neutropenia.After going on market drugs can have effectiveness and safety that differ from our expectation.Thus, post-marketing evaluation is both necessary and essential.The research will summarize series of studies of Shenmai injection conducted by our team (bibliometric analysis,systems analysis,electronic medical data analysis and safety data analysis of spontaneous reporting system),to provide scientific basis for proper use.%参麦注射液临床上常用于休克、冠心病、病毒性心肌炎、慢性肺心病、粒细胞减少症的治疗。药品上市后在临床真实世界的使用中,其有效性与安全性往往会与已知情况有所不同,因而,药品上市后临床再评价非常必须与必要。本文从本团队进行的参麦注射液上市后文献计量分析、系统评价以及基于电子医疗数据分析和自发呈报系统安全性数据分析等方面,进行系列研究综述,以为临床安全合理用药提供依据。

  13. The impact of neutralizing antibodies on the risk of disease worsening in interferon β-treated relapsing multiple sclerosis: a 5 year post-marketing study.

    Science.gov (United States)

    Paolicelli, D; D'Onghia, M; Pellegrini, F; Direnzo, V; Iaffaldano, P; Lavolpe, V; Trojano, M

    2013-06-01

    The impact of neutralizing antibodies (NAbs) on interferon β (IFNβ) efficacy in MS patients is still an object of controversy. To evaluate the clinical response to IFNβ during NAb-positive (NAb+) and NAb-negative (NAb-) statuses on a large population of relapsing remitting (RR) MS patients were followed up to 5 years. Sera from 567 RR MS patients treated with IFNβ for 2-5 years were collected every 6-12 months and evaluated for NAb presence by a cytopathic effect assay. The relapse rate and expanded disability status scale (EDSS) score were assessed at baseline and every 6 months for each patient. A NAb+ status was defined after two consecutive positive titers of NAbs >/= 20 neutralizing units (NU)/mL. Multivariate models were used to analyze the relapse rate, the time to first relapse, the time to confirmed EDSS score 4 during NAb+ and NAb- statuses. A propensity score (PS) matching analysis was performed to assess the robustness of the multivariate models. Fourteen percent of patients became NAb+ during the follow-up. A significant increase of the relapse rate (IRR = 1.38; p = 0.0247) and decrease of the time to 1st relapse (IRR = 1.51; p = 0.0111) were found during NAb+ periods. The PS matching analysis, in a selected cohort of patients, demonstrated a negative trend of NAbs on the time to reach the milestone EDSS 4 (IRR = 2.94; p = 0.0879). This long-term post-marketing observational study further confirms that the occurrence of NAbs significantly affects the risk of disease worsening in IFNβ- treated RRMS.

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

    Science.gov (United States)

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

    2011-01-01

    Many factors contribute to the onset of insomnia. However, few studies have identified the factors related to the onset of insomnia in hypertensive patients. We conducted a pharmacoepidemiologic study to examine the incidence of insomnia in hypertensive patients by using a post-marketing surveillance database. The insomnia onset was defined as the time of first prescription of hypnotics. The insomnia incidence rate in hypertensive patients under antihypertensive therapy was 0.77/100 person-years. The median insomnia onset date was 5 weeks. The insomnia type in 50.2% of the patients was difficulty in initiating sleep. We assessed the factors contributing to insomnia by using a nested case-control design. We selected 10 time-matched controls for every case. The hypotensive effect induced by antihypertensive therapy on the case group was lesser than that on the control group (p4-4.98), β blockers (OR, 1.54; 95% CI, 0.99-2.39), and calcium channel blockers (OR, 0.62; 95% CI, 0.43-0.90) compared with angiotensin-converting enzyme inhibitors; female sex (OR, 1.76; 95% CI, 1.27-2.44); complication of gastric/duodenal disorders (OR, 2.35; 95% CI, 1.14-4.86) or musculoskeletal system/connective tissue disorders (OR, 2.43; 95% CI, 1.23-4.79); and concomitant antihypertensive therapy (OR, 0.44; 95% CI, 0.31-0.63). This study identified the potential factors that may help to predict insomnia onset in hypertensive patients under antihypertensive therapy.

  15. Building up Evidence Body for Post-marketing Chinese Medicines Research%构建中药上市后安全性评价证据体的思考

    Institute of Scientific and Technical Information of China (English)

    廖星; 谢雁鸣

    2014-01-01

    Safety surveillance is the most important aspect for post-marketing research of Chinese medicine.However,passive monito-ring systems or phase four clinical trials or large sample epidemiology studies were historically the common ways of surveillance of post-marketing Chinese medicine.However those studies can no longer meet the expectations,and there are many more evidence sources for post-marketing Chinese medicine safety evaluation,eg.active surveillance from observational cohort study and study on hospital informa-tion system.These data and study can provide adequate source data for post-marketing Chinese medicine research.The most prominent problem is how to integrate different evidences from multiple sources.This article suggests we should build an evidence-based system to evaluate post-marketing Chinese medicines safety.%中药上市后安全性评价关乎用药患者在临床应用中的生命安全,关系着国家医疗卫生政策的导向,以及药厂对药品开发规划设计。上市后药品的安全监测无疑是所有上市后药品的重要内容,而监测主要关注药品在上市前未曾发现的那些潜在的不良反应/事件。既往,上市后药物监测习惯以被动监测模式或者是四期的临床试验或者是大型的流行病学调查,这些统被称之为安全性监测或药物警戒研究。现今,研究者们发现这些方法或方式远远不能满足当下对于上市后药品安全性评价的证据需求。为此,为了能够弥补这些证据积累的不足,目前亟需发展新的证据研究模式,比如转向大样本大范围的主动监测,采用队列观察性研究方法,基于真实世界医疗电子数据库等等。本文基于上市后中药的特点,从循证医学证据理念出发,提出构建中药上市后安全性评价证据体的设想来对未来中药上市后安全性评价研究提供参考。

  16. Italian post-marketing surveillance for adverse event reports after MF59-adjuvanted H1N1v vaccination.

    Science.gov (United States)

    Parretta, Elisabetta; Ianniello, Benedetta; Ferrazin, Fernanda; Rossi, Francesco; Capuano, Annalisa

    2011-05-09

    According to European recommendations, the Italian Medicines Agency (AIFA) required close monitoring of the safety of the MF59-adjuvanted H1N1v vaccine, which was the only vaccine available in Italy for prophylaxis of the A/H1N1 (2009) pandemic influenza. From October 2009 to June 2010, the Italian Pharmacovigilance Adverse Event (AE) Spontaneous Reporting System [Rete Nazionale Farmacovigilanza] (RNF) received 1330 reports of AEs temporally related with the pandemic influenza vaccination out of a total of 924,057 doses administered. Among these, 1,162 (87.37%) AE reports were classified 'non serious', 91 (6.84%) 'serious', 3 (0.23%) had a fatal outcome and 74 (5.56%) did not include the degree of seriousness. Among the serious AE reports, some unexpected AEs emerged. Even though some typical vaccine safety issues which emerged should be further explored, such as vaccination in pregnancy, the analysis of all AE reports sent to RNF shows that the vaccine has a well-tolerated safety profile which resembles that of the already available seasonal influenza vaccines. This contrasts with the widespread public concern about its safety, which has been one of the major causes of the low vaccination rate observed in Italy, as well as in other countries.

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

    Directory of Open Access Journals (Sweden)

    Plaizier-Vercammen Jacqueline

    2007-01-01

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

  18. 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...

  19. 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.

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

    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.

  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 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.

  2. HPV vaccine (Human Papillomavirus) Cervarix® - what you need to know

    Science.gov (United States)

    ... symptoms, and go away on their own. But HPV can cause cervical cancer in women. Cervical cancer is the second leading ... vaccine you are getting is one of two HPV vaccines that can be given to prevent cervical cancer. It is given to females only. The other ...

  3. 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

  4. 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

  5. The risk of bleeding with duloxetine treatment in patients who use nonsteroidal anti-inflammatory drugs (NSAIDs: analysis of placebo-controlled trials and post-marketing adverse event reports

    Directory of Open Access Journals (Sweden)

    Perahia DG

    2013-11-01

    Full Text Available David G Perahia,1 Mark E Bangs,2 Qi Zhang,2 Yingkai Cheng,2 Jonna Ahl,2 Elijah P Frakes,2 Michael J Adams,2 James M Martinez2 1Neurosciences, Lilly Research Centre, Windlesham, Surrey, UK; 2Neurosciences, Eli Lilly and Company, Indianapolis, IN, USA Purpose: To assess the safety of duloxetine with regards to bleeding-related events in patients who concomitantly did, versus did not, use nonsteroidal anti-inflammatory drugs (NSAIDs, including aspirin. Methods: Safety data from all placebo-controlled trials of duloxetine conducted between December 1993 and December 2010, and post-marketing reports from duloxetine-treated patients in the US Food and Drug Administration Adverse Event Reporting System (FAERS, were searched for bleeding-related treatment-emergent adverse events (TEAEs. The percentage of patients with bleeding-related TEAEs was summarized and compared between treatment groups in all the placebo-controlled studies. Differences between NSAID user and non-user subgroups from clinical trial data were analyzed by a logistic regression model that included therapy, NSAID use, and therapy-by-NSAID subgroup interaction. In addition, to determine if higher duloxetine doses are associated with an increased incidence of bleeding-related TEAEs, and whether the use of concomitant NSAIDs might influence the dose effect if one exists, placebo-controlled clinical trials with duloxetine fixed doses of 60 mg, 120 mg, and placebo were analyzed. Also, the incidence of bleeding-related TEAEs reported for duloxetine alone was compared with the incidence in patients treated with duloxetine and concomitant NSAIDs. Finally, the number of bleeding-related cases reported for duloxetine in the FAERS database was compared with the numbers reported for all other drugs. Results: Across duloxetine clinical trials, there was a significantly greater incidence of bleeding-related TEAEs in duloxetine- versus placebo-treated patients overall and also in those patients who

  6. 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.

  7. Requirements dilemma

    OpenAIRE

    2006-01-01

    This thesis was submitted for the degree of Doctor of Philosophy and awarded by Brunel University. Knowing ‘what’ to build is an integral part of an Information System Development, and it is generally understood that this, which is known as Requirements, is achievable through a process of understanding, communication and management. It is currently maintained by the Requirements theorists that successful system design clarifies the interrelations between information and its representations...

  8. [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.

  9. A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips.

    Science.gov (United States)

    Philipp-Dormston, Wolfgang G; Hilton, Said; Nathan, Myooran

    2014-06-01

    Hyaluronic acid (HA)-based injectable fillers three-dimensionally restore the natural contours of the lips and perioral area, thereby reducing some signs of aging lips. To evaluate the short-term aesthetic impact of treatment with the HA dermal filler Juvéderm(®) VOLBELLA(®) with Lidocaine, formulated utilizing VYCROSS(™) technology, for enhancement or correction of asymmetry of the lips, evaluated using a patient-centric approach. Sixty-two subjects were enrolled in this study, conducted at two sites in Germany. Primary endpoints were satisfaction with improvement, look and feel of the lips, assessed by subject and physician at first visit and 4 weeks post-treatment. Immediately after injection at first visit, 83.6% of subjects were Extremely Satisfied, Very Satisfied or Satisfied with improvement in the lips, which increased to 94.1% and 93.0% of subjects with/without top-up treatment at follow-up, respectively. After injection at first visit, 61.7% of subjects rated the look and feel of their lips as Extremely Natural or Very Natural, which increased to 75.0% and 93.0% of subjects with/without top-up treatment, respectively. The HA dermal filler was associated with minimal discomfort, bruising or swelling of the lips; almost two-thirds of subjects (62%) returned to social engagements on the same day. The high degree of subject satisfaction with aesthetic improvement in the lips, as well as the natural look and feel, indicates that this HA dermal filler represents an effective treatment option for patients requiring lip enhancement.

  10. An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland, who have been prescribed Sativex® (THC:CBD, nabiximols oromucosal spray

    Directory of Open Access Journals (Sweden)

    Etges T

    2016-11-01

    Full Text Available Tilden Etges, Kari Karolia, Thomas Grint, Adam Taylor, Heather Lauder, Brian Daka, Stephen Wright GW Pharmaceuticals, Cambridge, UK Abstract: The global exposure of Sativex® (Δ9-tetrahydrocannabinol [THC]:cannabidiol [CBD], nabiximols is estimated to be above 45,000 patient-years since it was given marketing approval for treating treatment-resistant spasticity in multiple sclerosis (MS. An observational registry to collect safety data from patients receiving THC:CBD was set up following its approval in the UK, Germany, and Switzerland, with the aim of determining its long-term safety in clinical practice. Twice a year, the Registry was opened to prescribing physicians to voluntarily report data on patients’ use of THC:CBD, clinically significant adverse events (AEs, and special interest events. The Registry contains data from 941 patients with 2,213.98 patient-years of exposure. Within this cohort, 60% were reported as continuing treatment, while 83% were reported as benefiting from the treatment. Thirty-two percent of patients stopped treatment, with approximately one third citing lack of effectiveness and one quarter citing AEs. Psychiatric AEs of clinical significance were reported in 6% of the patients, 6% reported falls requiring medical attention, and suicidality was reported in 2%. Driving ability was reported to have worsened in 2% of patients, but improved in 7%. AEs were more common during the first month of treatment. The most common treatment-related AEs included dizziness (2.3% and fatigue (1.7%. There were no signals to indicate abuse, diversion, or dependence. The long-term risk profile from the Registry is consistent with the known (labeled safety profile of THC:CBD, and therefore supports it being a well-tolerated and beneficial medication for the treatment of MS spasticity. No evidence of new long-term safety concerns has emerged. Keywords: cannabidiol, tetrahydrocannabinol, non-interventional, multiple sclerosis

  11. International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.

    Science.gov (United States)

    2016-06-23

    The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.

  12. 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.

  13. Innovations in Post-Marketing Safety Research

    NARCIS (Netherlands)

    Stefánsdóttir, G.

    2012-01-01

    Safety surveillance is important during the entire life cycle of a drug. Pre-marketing trials have been shown to be ineffective in establishing the full safety profile of the drug, mainly due to their relatively small sample size and characteristics of the patients, which are usually younger and hea

  14. Phase 0 clinical trials and post-marketed re-evaluation of clinical safety in injection of traditional Chinese medicine%0期临床试验与中药注射剂上市后临床安全性再评价

    Institute of Scientific and Technical Information of China (English)

    谢雁鸣; 魏戌; 张占军; 王永炎

    2011-01-01

    中药注射剂不良反应时有发生,临床安全性问题亟待解决,需要进行上市后临床安全性再评价,过敏反应是不良反应评价的主要内容之一.对含有毒药材的中成药、有安全问题的中药注射剂需要开展0期临床试验,0期临床试验使用“微剂量”研究周期内收集必要的药物安全性及药代动力学试验数据,微剂量可以反映中药注射剂的致敏情况.0期临床试验为上市后中药注射剂的安全性再评价提供了新的方法,是否进行0期临床试验,应依据品种是否有安全性问题而定,中药注射剂初始剂量以及样本含量的确定是研究设计的关键问题.%Adverse drug reaction induced by injection of traditional Chinese medicine ( TCM ) often occurs. Post-marketed re-evaluation of clinical safety in injection of TCM is indispensable, in order to solve the clinical safety problems. It is necessary to conduct Phase 0 clinical trials for containing toxic medicine and injection of TCM. Phase 0 clinical trials, involving very limited human exposure, and using microdose of drugs,are intended to collect the necessary safety and pharmacokinetic data in limited period. Microdose reflects allergies of injection of TCM. Phase 0 clinical trials provide a new method for post-marketed re-evaluation of safety in injection of TCM. Its use depends on whether there is a safety problem for injection of TCM, and the determination of initial dose and sample size are key questions in study design.

  15. 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

  16. Feed tank transfer requirements

    Energy Technology Data Exchange (ETDEWEB)

    Freeman-Pollard, J.R.

    1998-09-16

    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.

  17. Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine%FDA风险控制计划指南及其对我国中药上市后风险管理的启示

    Institute of Scientific and Technical Information of China (English)

    黎元元; 谢雁鸣

    2011-01-01

    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.%该文介绍了FDA风险控制计划(risk evaluation and mitigation strategy,REMS)指南,并结合实例芬太尼的FOCUS风险控制计划进行分析REMS的内容组成.我国可借鉴美国的相关经验,建立科学的药品再评价机制,强化风险意识,促进合理用药,将中药上市前和上市后评价有机结合,促进我国药品风险管理的发展与完善.

  18. 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.

  19. 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.

  20. Ontology Requirements Specification

    OpenAIRE

    Suárez-Figueroa, Mari Carmen; Gómez-Pérez, A.

    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...

  1. User Requirements for Wireless

    DEFF Research Database (Denmark)

    technologies or software has been developed. A variety of user requirements are provided illustrating the effect of changing the targeted user group with respect to age,; to the context and the different technologies or software as well as to the difference in viewpoint on ways of involving users...... 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...... involvement and requirements elicitation Usable security requirements for design of privacy...

  2. Post-marketing Evaluation of Clinical Application of St. John's Wort Extract(Neurostan®) in China%圣•约翰草提取物片(路优泰®)国内上市后临床应用评价

    Institute of Scientific and Technical Information of China (English)

    贡联兵

    2016-01-01

    目的:评价圣•约翰草提取物片(路优泰®)上市后国内临床应用情况,为临床用药提供借鉴。方法:查阅国内外相关文献,对路优泰上市后国内临床使用的适应证、有效性、安全性、经济学等方面进行评价。结果与结论:路优泰目前已在国内广泛用于治疗轻、中度抑郁症,焦虑和烦躁不安等疾病,其临床应用在不断扩展。鉴于路优泰不良反应轻微、价格相对便宜,路优泰的应用前景将会更加广阔。%Objective: To do the post-marketing evaluation ofclinical application of St. John's Wort Extracts (Neurostan®) in China, and provide the reference for clinical practice.Method: We searched the relevantliterature at domestic and abroad, and reviewed the indications, treatment efficacy, safety and cost-benefit of Neurosta after listing in China. Result andConclusion: Neurostan has been widely used to treat mild to moderate depression, anxiety and restlessness in China. And its clinical applications are expanding. Due to less side effect and cheaper cost, applications of Neurostan will be broader in the future.

  3. Replacing reserve requirements

    OpenAIRE

    Edward J. Stevens

    1993-01-01

    An examination of the fading significance of the Federal Reserve System's reserve requirements and the recent flowering of required clearing balances, a rapidly growing feature of Reserve Bank operations.

  4. 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....

  5. 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.

  6. 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...

  7. Transportation System Requirements Document

    Energy Technology Data Exchange (ETDEWEB)

    1993-09-01

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

  8. 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.

  9. 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...

  10. Anthropometric Requirements for Constellation

    Science.gov (United States)

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

    2009-01-01

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

  11. 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.

  12. 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

  13. 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.

  14. 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...

  15. 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...

  16. Ecodesign requirements for televisions

    DEFF Research Database (Denmark)

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

    2013-01-01

    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......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...

  17. 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.

  18. 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.

  19. BRD usability requirements

    Energy Technology Data Exchange (ETDEWEB)

    Deshpande, Alina [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2015-03-12

    This document describes the usability requirements for the Biosurveillance resource directory (BRD); that is, who will be using the tool and what tasks they will be using it for. It does not include information on technical implementation (e.g., whether specific information is contained in the database or pulled on demand from other sources). It also avoids specific design ideas (such as widget descriptions) unless they are necessary to illustrate a requirement.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. Functional Requirements Study

    Science.gov (United States)

    2008-07-01

    security, and statistical needs. Some of the major requirements include real time operational, hydrological, and climate data for tactical operation...Milltech Marine (distributor), US / Smart Radio ( Shenzhen Yuantong Telecom), China SR161 AIS Receiver http://www.milltechmarine.com Nasa Marine, UK AIS

  5. Lunar base construction requirements

    Science.gov (United States)

    Jolly, Steve; Helleckson, Brent

    1990-01-01

    The following viewgraph presentation is a review of the Lunar Base Constructibility Study carried out in the spring and summer of 1990. The objective of the study was to develop a method for evaluating the constructibility of Phase A proposals to build facilities on orbit or on extraterrestrial surfaces. Space construction was broadly defined as all forms of assembly, disassembly, connection, disconnection, deployment, stowage, excavation, emplacement, activation, test, transportation, etc., required to create facilities in orbit and on the surfaces of other celestial bodies. It was discovered that decisions made in the face of stated and unstated assumptions early in the design process (commonly called Phase A) can lock in non-optimal construction methods. Often, in order to construct the design, alterations must be made to the design during much later phases of the project. Such 'fixes' can be very difficult, expensive, or perhaps impossible. Assessing constructibility should thus be a part of the iterative design process, starting with the Phase A studies and continuing through production. This study assumes that there exists a minimum set of key construction requirements (i.e., questions whose answers form the set of discriminators) that must be implied or specified in order to assess the constructibility of the design. This set of construction requirements constitutes a 'constructibility filter' which then becomes part of the iterative design process. Five inherently different, dichotomous design reference missions were used in the extraction of these requirements to assure the depth and breath of the list.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Army Sociocultural Performance Requirements

    Science.gov (United States)

    2014-06-01

    L., Crafts, J. L., & Brooks, J. E. (July 1995). Intercultural communication requirements for Special Forces teams. (Study Report 1683). Arlington... Communication Uses alternative, sometimes novel, methods to communicate when verbal language is not shared; conveys information about mood, intent...status, and demeanor via gestures, tone of voice, and facial expressions; improvises communication techniques as necessary. WI Works with Interpreters

  11. 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.

  12. 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

  13. Entrepreneurial learning requires action

    DEFF Research Database (Denmark)

    Brink, Tove; Madsen, Svend Ole

    2014-01-01

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

  14. 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.

  15. Issues in Requirements Elicitation

    Science.gov (United States)

    1992-09-01

    systems approach: characterized by Checkland’s Soft Systems Methodology (SSM), which is discussed briefly in Appendix A.6; emphasizes the subjectivity of...methodology for requirements elicitation. A.6 Notes on SSM Both the definition of methodology and the philosophy behind soft systems methodology (SSM...1986. [Checkland 89a] Checkland, Peter. Soft Systems Methodology . Rational Analysis for a Problematic World. New York: John Wiley & Sons, 71-100

  16. Reusable Security Requirements

    Science.gov (United States)

    2016-06-13

    2003 by Carnegie Mellon University page 1 Carnegie Mellon Software Engineering Institute Reusable Security Requirements RE’2003 RHAS’03 Workshop...PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Carnegie Mellon University , Software Engineering Institute,Pittsburgh,PA,15213 8. PERFORMING...Carnegie Mellon University page 2 Carnegie Mellon Software Engineering Institute In a Nut Shell • Similar Assets, Attackers, and Threats • Security

  17. Getting the Requirements Right

    Science.gov (United States)

    2015-08-01

    community closely to the Navy acquisition community, and vice versa. It is also important to the Department of the Navy to understand how technical...that the technical specification, statement of work, and Request for Proposal (RFP) have accurately translated the warfighter’s requirements into an...estimating, and financial management to the acquisition of weapons systems, platforms and services. These Navy Pro- viders acquire the material and

  18. 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.

  19. Human Systems Integration Requirements

    Science.gov (United States)

    2009-09-01

    Performance Parameter (NR-KPP) Products (aka Architectures )  Appendix B: References  Appendix C: Acronym List  Appendix D: Analysis methodology...Force Specialty Codes 36 HSI REQUIREMENTS GUIDE Universal Joint Task List Full Mission Trainers ( FMT ) Field Training Detachments On-the-Job...Occupational Health F3I Form-Fit-Function Interface FM Field Manual FMT Full Mission Trainers FOA Field Operating Agencies FOC Full Operational

  20. Phi factory detector requirements

    Energy Technology Data Exchange (ETDEWEB)

    Arisaka, K.; Atac, M.; Berg, R.; Buchanan, C.; Calvette, M.; Khazin, B.; Kinoshita, K.; Muller, T.; Ohshima, T.; Olsen, S.; Park, J.; Santoni, C.; Shirai, J.; Solodov, E.; Thompson, J.; Triggiani, G.; Ueno, K.; Yamamoto, H.; Detector and Simulation Working Group

    1991-08-01

    We identify the experimental problems and the conditions required for successful phi-factory operation, and show the range of detector parameters which, in conjunction with different machine designs, may meet these conditions. We started by considering, comparing and criticizing the Italian and Novosibirsk designs. With this discussion as a background, we defined the apparent experimental problems and detector constraints. In this article we summarize our understanding. (orig./HSI).

  1. 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.

  2. 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.

  3. 21 CFR 314.81 - Other postmarketing reports.

    Science.gov (United States)

    2010-04-01

    ... clinical benefit studies, pediatric studies) or that the applicant has committed, in writing, to conduct... that is responsible for the facility involved within 3 working days of receipt by the applicant. The... information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new...

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. THE EQUALITY PRINCIPLE REQUIREMENTS

    Directory of Open Access Journals (Sweden)

    CLAUDIA ANDRIŢOI

    2013-05-01

    Full Text Available The problem premises and the objectives followed: the idea of inserting the equality principle between the freedom and the justice principles is manifested in positive law in two stages, as a general idea of all judicial norms and as requirement of the owner of a subjective right of the applicants of an objective law. Equality in face of the law and of public authorities can not involve the idea of standardization, of uniformity, of enlisting of all citizens under the mark of the same judicial regime, regardless of their natural or socio-professional situation. Through the Beijing Platform and the position documents of the European Commission we have defined the integrative approach of equality as representing an active and visible integration of the gender perspective in all sectors and at all levels. The research methods used are: the conceptualist method, the logical method and the intuitive method necessary as means of reasoning in order to argue our demonstration. We have to underline the fact that the system analysis of the research methods of the judicial phenomenon doesn’t agree with “value ranking”, because one value cannot be generalized in rapport to another. At the same time, we must fight against a methodological extremism. The final purpose of this study is represented by the reaching of the perfecting/excellence stage by all individuals through the promotion of equality and freedom. This supposes the fact that the existence of a non-discrimination favourable frame (fairness represents a means and a condition of self-determination, and the state of perfection/excellency is a result of this self-determination, the condition necessary for the obtaining of this nondiscrimination frame for all of us and in conditions of freedom for all individuals, represents the same condition that promotes the state of perfection/excellency. In conclusion we may state the fact that the equality principle represents a true catalyst of the

  14. Software Security Requirements Gathering Instrument

    Directory of Open Access Journals (Sweden)

    Smriti Jain

    2011-08-01

    Full Text Available Security breaches are largely caused by the vulnerable software. Since individuals and organizations mostly depend on softwares, it is important to produce in secured manner. The first step towards producing secured software is through gathering security requirements. This paper describes Software Security Requirements Gathering Instrument (SSRGI that helps gather security requirements from the various stakeholders. This will guide the developers to gather security requirements along with the functional requirements and further incorporate security during other phases of software development. We subsequently present case studies that describe the integration of the SSRGI instrument with Software Requirements Specification (SRS document as specified in standard IEEE 830-1998. Proposed SSRGI will support the software developers in gathering security requirements in detail during requirements gathering phase.

  15. Software Security Requirements Gathering Instrument

    OpenAIRE

    2011-01-01

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

  16. Architecture-driven requirements prioritization

    OpenAIRE

    2012-01-01

    Quality requirements are main drivers for architectural decisions of software systems. However, in practice they are often dismissed during development, because of initially unknown dependencies and consequences that complicate implementation. To decide for meaningful, feasible quality requirements and trade them off with functional requirements, tighter integration of software architecture evaluation and requirements prioritization is necessary. In this position paper, we propose a tool-supp...

  17. Requirement Development Process and Tools

    Science.gov (United States)

    Bayt, Robert

    2017-01-01

    Requirements capture the system-level capabilities in a set of complete, necessary, clear, attainable, traceable, and verifiable statements of need. Requirements should not be unduly restrictive, but should set limits that eliminate items outside the boundaries drawn, encourage competition (or alternatives), and capture source and reason of requirement. If it is not needed by the customer, it is not a requirement. They establish the verification methods that will lead to product acceptance. These must be reproducible assessment methods.

  18. 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…

  19. Guide to requirements SL-07

    DEFF Research Database (Denmark)

    Lauesen, Søren

    IT developers and consultants often ask for an exemplary requirements specification as a starting point for their specific project. This document is the guide to such a specification, Requirements Template SL-07. The specification itself is a template filled out with a complex example: requirements...

  20. Requirements Reasoning for Distributed Requirements Analysis using Semantic Wiki

    OpenAIRE

    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 activities rarely apply formal techniques; therefore it is infeasible to automatically detect problems in requirements. This situation becomes even worse in a distributed context when all sites are respon...

  1. 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

  2. Flight program language requirements. Volume 2: Requirements and evaluations

    Science.gov (United States)

    1972-01-01

    The efforts and results are summarized for a study to establish requirements for a flight programming language for future onboard computer applications. Several different languages were available as potential candidates for future NASA flight programming efforts. The study centered around an evaluation of the four most pertinent existing aerospace languages. Evaluation criteria were established, and selected kernels from the current Saturn 5 and Skylab flight programs were used as benchmark problems for sample coding. An independent review of the language specifications incorporated anticipated future programming requirements into the evaluation. A set of detailed language requirements was synthesized from these activities. The details of program language requirements and of the language evaluations are described.

  3. Software package requirements and procurement

    OpenAIRE

    1996-01-01

    This paper outlines the problems of specifying requirements and deploying these requirements in the procurement of software packages. Despite the fact that software construction de novo is the exception rather than the rule, little or no support for the task of formulating requirements to support assessment and selection among existing software packages has been developed. We analyse the problems arising in this process and review related work. We outline the key components of a programme of ...

  4. 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...

  5. Physician Requirements-1990. For Nephrology.

    Science.gov (United States)

    Rosenbach, Joan K.

    Professional requirements for physicians specializing in nephrology were estimated to assist policymakers in developing guidelines for graduate medical education. In estimating service requirements for nephrology, a nephrology Delphi panel reviewed reference and incidence-prevalence and utilization data for 34 conditions that are treated in the…

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations.

    Science.gov (United States)

    Freckmann, Guido; Schmid, Christina; Baumstark, Annette; Rutschmann, Malte; Haug, Cornelia; Heinemann, Lutz

    2015-07-01

    In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood glucose (SMBG) before the market approval. In 2013, a revised version of this standard was published. Relevant revisions in the analytical performance requirements are the inclusion of the evaluation of influence quantities, for example, hematocrit, and some changes in the testing procedures for measurement precision and system accuracy evaluation, for example, number of test strip lots. Regarding system accuracy evaluation, the most important change is the inclusion of more stringent accuracy criteria. In 2014, the Food and Drug Administration (FDA) in the United States published their own guidance document for the premarket evaluation of SMBG systems with even more stringent system accuracy criteria than stipulated by ISO 15197:2013. The establishment of strict accuracy criteria applicable for the premarket evaluation is a possible approach to further improve the measurement quality of SMBG systems. However, the system accuracy testing procedure is quite complex, and some critical aspects, for example, systematic measurement difference between the reference measurement procedure and a higher-order procedure, may potentially limit the apparent accuracy of a given system. Therefore, the implementation of a harmonized reference measurement procedure for which traceability to standards of higher order is verified through an unbroken, documented chain of calibrations is desirable. In addition, the establishment of regular and standardized post-marketing evaluations of distributed test strip lots should be considered as an approach toward an improved measurement quality of available SMBG systems.

  11. 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.

  12. Autonomous Real Time Requirements Tracing

    Science.gov (United States)

    Plattsmier, George; Stetson, Howard

    2014-01-01

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

  13. 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.

  14. Physical requirements in Olympic sailing

    DEFF Research Database (Denmark)

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

    2015-01-01

    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...... the last few years to involve more agile, fast and spectacular yachts. The change of events in Olympic sailing has likely added to physical requirements; however, data on sailors in the modern-type yachts are scarce. The present paper describes the recent developments in Olympic sailing with respect...

  15. 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.

  16. 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...

  17. 76 FR 39259 - Manual Requirements

    Science.gov (United States)

    2011-07-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 91 Manual Requirements AGENCY: Federal Aviation Administration, DOT. ACTION: Final rule; technical amendment. SUMMARY: The Federal Aviation Administration (FAA)...

  18. 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.

  19. Requirements: The Key to Sustainability

    OpenAIRE

    2016-01-01

    Software's critical role in society demands a paradigm shift in the software engineering mind-set. This shift's focus begins in requirements engineering. This article is part of a special issue on the Future of Software Engineering.

  20. 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.

  1. 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 ...

  2. 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.

  3. Capturing Requirements for Autonomous Spacecraft with Autonomy Requirements Engineering

    Science.gov (United States)

    Vassev, Emil; Hinchey, Mike

    2014-08-01

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

  4. GRID INFORMATION SECURITY FUNCTIONAL REQUIREMENT

    Directory of Open Access Journals (Sweden)

    Amy Poh Ai Ling

    2011-07-01

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

  5. 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...

  6. Fusion Energy Sciences Network Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Dart, Eli [ESNet, Berkeley, CA (United States); Tierney, Brian [ESNet, Berkeley, CA (United States)

    2012-09-26

    The Energy Sciences Network (ESnet) is the primary provider of network connectivity for the U.S. 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 25 years. In December 2011, ESnet and the Office of Fusion Energy Sciences (FES), of the DOE Office of Science (SC), organized a workshop to characterize the networking requirements of the programs funded by FES. The requirements identified at the workshop are summarized in the Findings section, and are described in more detail in the body of the report.

  7. 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.

  8. 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.

  9. Technological requirements of profile machining

    Institute of Scientific and Technical Information of China (English)

    PARK Sangchul; CHUNG Yunchan

    2006-01-01

    The term ‘profile machining’is used to refer to the milling of vertical surfaces described by profile curves. Profile machining requires higher precision (1/1000 mm) than regular 3D machining (1/100 mm) with the erosion of sharp vertices should being especially avoided. Although, profile machining is very essential for making trimming and flangedies, it seldom brought into focus. This paper addresses the technological requirements of profile machining including machining width and depth control,minimizing toolware, and protecting sharp vertices. Issues of controller alarms are also addressed.

  10. 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

  11. 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.

  12. OBJECTIVITY REQUIREMENT FOR FLUID DYNAMICS

    Institute of Scientific and Technical Information of China (English)

    邹文楠

    2003-01-01

    A new flow theory is established through the objectivity requirement on the fluid dynamics. It was known that inhomogeneous fluid motion gave rise to viscous force while the selection of observers on different space-time points would change such an inhomogeneous character. Therefore, when the viscous force was considered as an objective existence foreign to the selection of observers, the form invariances of viscous force and momentum equation under local rotation transformation required a new dynamic field,namely the vortex field to be introduced. Then the dynamical equations of all flow fields were obtained through constructing the Lagrangian density of fluid system and using the variational approach of energy.

  13. 78 FR 74151 - Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Waiver...

    Science.gov (United States)

    2013-12-10

    ... Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation... auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration... technology. Reporting in Accordance With International Conference on Harmonisation--Periodic...

  14. No Previous Public Services Required

    Science.gov (United States)

    Taylor, Kelley R.

    2009-01-01

    In 2007, the Supreme Court heard a case that involved the question of whether a school district could be required to reimburse parents who unilaterally placed their child in private school when the child had not previously received special education and related services in a public institution ("Board of Education v. Tom F."). The…

  15. WATER REQUIREMENT 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...

  16. 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...

  17. Utilizing inheritance in requirements engineering

    Science.gov (United States)

    Kaindl, Hermann

    1994-01-01

    The scope of this paper is the utilization of inheritance for requirements specification, i.e., the tasks of analyzing and modeling the domain, as well as forming and defining requirements. Our approach and the tool supporting it are named RETH (Requirements Engineering Through Hypertext). Actually, RETH uses a combination of various technologies, including object-oriented approaches and artificial intelligence (in particular frames). We do not attempt to exclude or replace formal representations, but try to complement and provide means for gradually developing them. Among others, RETH has been applied in the CERN (Conseil Europeen pour la Rechereche Nucleaire) Cortex project. While it would be impossible to explain this project in detail here, it should be sufficient to know that it deals with a generic distributed control system. Since this project is not finished yet, it is difficult to state its size precisely. In order to give an idea, its final goal is to substitute the many existing similar control systems at CERN by this generic approach. Currently, RETH is also tested using real-world requirements for the Pastel Mission Planning System at ESOC in Darmstadt. First, we outline how hypertext is integrated into a frame system in our approach. Moreover, the usefulness of inheritance is demonstrated as performed by the tool RETH. We then summarize our experiences of utilizing inheritance in the Cortex project. Lastly, RETH will be related to existing work.

  18. 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.

  19. 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.

  20. Aligning seminars with Bologna requirements

    DEFF Research Database (Denmark)

    Lueg, Klarissa; Lueg, Rainer; Lauridsen, Ole

    2016-01-01

    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...

  1. 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....

  2. 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.

  3. 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,

  4. 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.

  5. 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.

  6. Superluminal travel requires negative energies

    OpenAIRE

    Olum, Ken D.

    1998-01-01

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

  7. 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.

  8. Quality requirements for EHR archetypes.

    Science.gov (United States)

    Kalra, Dipak; Tapuria, Archana; Austin, Tony; De Moor, Georges

    2012-01-01

    The realisation of semantic interoperability, in which any EHR data may be communicated between heterogeneous systems and fully understood by computers as well as people on receipt, is a challenging goal. Despite the use of standardised generic models for the EHR and standard terminology systems, too much optionality and variability exists in how particular clinical entries may be represented. Clinical archetypes provide a means of defining how generic models should be shaped and bound to terminology for specific kinds of clinical data. However, these will only contribute to semantic interoperability if libraries of archetypes can be built up consistently. This requires the establishment of design principles, editorial and governance policies, and further research to develop ways for archetype authors to structure clinical data and to use terminology consistently. Drawing on several years of work within communities of practice developing archetypes and implementing systems from them, this paper presents quality requirements for the development of archetypes. Clinical engagement on a wide scale is also needed to help grow libraries of good quality archetypes that can be certified. Vendor and eHealth programme engagement is needed to validate such archetypes and achieve safe, meaningful exchange of EHR data between systems.

  9. 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.

  10. Shielding requirements in helical tomotherapy

    Science.gov (United States)

    Baechler, S.; Bochud, F. O.; Verellen, D.; Moeckli, R.

    2007-08-01

    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.

  11. Meeting US and European supplier control requirements.

    Science.gov (United States)

    Donawa, Maria

    2009-01-01

    Medical device manufacturers operating under European quality system requirements are sometimes surprised to learn that their supplier control procedures do not fully meet United States (US) requirements. This article discusses important differences between US and European requirements for controlling suppliers.

  12. 15 CFR 286.5 - Program requirements.

    Science.gov (United States)

    2010-01-01

    ... public input derived from the application and interpretation of generic program requirements in relation... VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM § 286.5 Program requirements. NIST... prospective program participants and other interested parties. Generic requirements are developed with...

  13. Requirements and Markets for Nanoelectronics

    Science.gov (United States)

    Hoefflinger, Bernd

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

  14. 46 CFR 182.410 - General requirements.

    Science.gov (United States)

    2010-10-01

    ...) MACHINERY INSTALLATION Specific Machinery Requirements § 182.410 General requirements. (a) Starting motors.... Electrical equipment in spaces, compartments, or enclosures that contain machinery powered by, or fuel...

  15. 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.

  16. 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.

  17. Requirements engineering for digital health

    CERN Document Server

    Thümmler, Christoph; Gavras, Anastasius

    2015-01-01

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

  18. Moral enhancement requires multiple virtues.

    Science.gov (United States)

    Hughes, James J

    2015-01-01

    Some of the debates around the concept of moral enhancement have focused on whether the improvement of a single trait, such as empathy or intelligence, would be a good in general, or in all circumstances. All virtue theories, however, both secular and religious, have articulated multiple virtues that temper and inform one another in the development of a mature moral character. The project of moral enhancement requires a reengagement with virtue ethics and contemporary moral psychology to develop an empirically grounded model of the virtues and a fuller model of character development. Each of these virtues may be manipulable with electronic, psychopharmaceutical, and genetic interventions. A set of interdependent virtues is proposed, along with some of the research pointing to ways such virtues could be enhanced.

  19. Large-scale prediction of adverse drug reactions using chemical, biological, and phenotypic properties of drugs

    OpenAIRE

    Liu, Mei; Wu, Yonghui; Chen, Yukun; Sun, Jingchun; Zhao, Zhongming; Chen, Xue-wen; Matheny, Michael Edwin; Xu, Hua

    2012-01-01

    Objective Adverse drug reaction (ADR) is one of the major causes of failure in drug development. Severe ADRs that go undetected until the post-marketing phase of a drug often lead to patient morbidity. Accurate prediction of potential ADRs is required in the entire life cycle of a drug, including early stages of drug design, different phases of clinical trials, and post-marketing surveillance. Methods Many studies have utilized either chemical structures or molecular pathways of the drugs to ...

  20. VO₂ requirements of boxing exercises.

    Science.gov (United States)

    Arseneau, Eric; Mekary, Saïd; Léger, Luc A

    2011-02-01

    The purpose of this study was to quantify the physiological requirements of various boxing exercises such as sparring, pad work, and punching bag. Because it was not possible to measure the oxygen uptake (VO₂) of "true" sparring with a collecting gas valve in the face, we developed and validated a method to measure VO₂ of "true" sparring based on "postexercise" measurements. Nine experienced male amateur boxers (Mean ± SD: age = 22.0 ± 3.5 years, height = 176.0 ± 8.0 cm, weight = 71.4 ± 10.9 kg, number of fights = 13.0 ± 9.5) of regional and provincial level volunteered to participate in 3 testing sessions: (a) maximal treadmill test in the LAB, (b) standardized boxing training in the GYM, and (c) standardized boxing exercises in the LAB. Measures of VO₂, heart rate (HR), blood lactate concentration [LA], rated perceived exertion level, and punching frequencies were collected. VO₂ values of 43.4 ± 5.9, 41.1 ± 5.1, 24.7 ± 6.1, 30.4 ± 5.8, and 38.3 ± 6.5 ml·kg⁻¹·min⁻¹ were obtained, which represent 69.7 ± 8.0, 66.1 ± 8.0, 39.8 ± 10.4, 48.8 ± 8.5, and 61.7 ± 10.3%VO₂peak for sparring, pad work, and punching bag at 60, 120, and 180 b·min⁻¹, respectively. Except for lower VO₂ values for punching the bag at 60 and 120 b·min⁻¹ (p < 0.05), there was no VO₂ difference between exercises. Similar pattern was obtained for %HRmax with respective values of 85.5 ± 5.9, 83.6 ± 6.3, 67.5 ± 3.5, 74.8 ± 5.9, and 83.0 ± 6.0. Finally, sparring %HRmax and [LA] were slightly higher in the GYM (91.7 ± 4.3 and 9.4 ± 2.2 mmol·L⁻¹) vs. LAB (85.5 ± 5.9 and 6.1 ± 2.3 mmol·L⁻¹). Thus, in this study simulated LAB sparring and pad work required similar VO₂ (43-41 ml·kg⁻¹·min⁻¹, respectively), which corresponds to ~70%VO₂peak. These results underline the importance of a minimum of aerobic fitness for boxers and draw some guidelines for the intensity of training.

  1. 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

  2. 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,...

  3. 24 CFR 92.610 - Program requirements.

    Science.gov (United States)

    2010-04-01

    ... requirements. The following program requirements contained in subpart E of this part apply to the ADDI: (a... ADDI. (b) Distribution of assistance. The distribution of assistance requirements contained in § 92.201 apply to the ADDI. (c) Income determinations. The income determination requirements contained in §...

  4. 24 CFR 266.110 - Reserve requirements.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Reserve requirements. 266.110... Finance Agency Requirements § 266.110 Reserve requirements. (a) HFAs with top-tier designation or overall... establish a reserve account funded in accordance with the requirements set forth in paragraph (b) of...

  5. 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...

  6. 49 CFR 383.111 - Required knowledge.

    Science.gov (United States)

    2010-10-01

    ... 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. All commercial motor vehicle operators must have knowledge of the following general areas: (a) Safe...

  7. 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...

  8. Defining reclaimed water potability requirements

    Science.gov (United States)

    Janik, D. S.

    1986-01-01

    Water used during previous space missions has been either carried or made aloft. Future human space endeavors will probably have to utilize some form of water reclamation and recycling. There is little applied experience in either the US or foreign space programs with this technology. Water reclamation and recycling constitutes an engineering challenge of the broadest nature and will require an intensive research and development effort if this technology is to mature in time for practical use on the proposed US spacestation. In order for this to happen, reclaimed/recycled water specification will need to be devised to guide engineering development. Perhaps the most strigent specifications will involve water to be consumed. NASA's present Potable Water Specifications are not applicable to reclaimed or recycled potable water. No specifications for reclaimed or recycled potable water presently exist either inside or outside NASA. NASA's past experience with potable water systems is reviewed, limitations of the present Potable Water Specifications are examined, present world expertise with potable water reclamation/recycling systems and system analogs is reviewed, and an approach to developing pertinent Reclaimed/Recycled Potable Water Specifications for spacecraft is presented.

  9. 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.

  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. E-ELT requirements flow down

    Science.gov (United States)

    Gonzalez, J. C.; Kurlandczyk, H.; Schmid, C.; Schneller, D.

    2016-08-01

    One of the critical activities in the systems engineering scope of work is managing requirements. In line with this, E-ELT devotes a significant effort to this activity, which follows a well-established process. This involves optimally deriving requirements from the user (Top-Level Requirements) through the system Level 1 Requirements and from here down to subsystems procurement specifications. This paper describes the process, which is illustrated with some practical examples, including in particular the role of technical budgets to derive requirements on subsystems. Also, the provisions taken for the requirements verification are discussed.

  12. Manpower Requirements Report for Fiscal Year 1976

    Science.gov (United States)

    1975-02-01

    IX-3 DC-3 DC-5 ■ PART C - MANPOWER REQUIREMENTS BY SERVICE . X Army Manpower Requirement« X-l i XI Navy Manpower Requirement« XI-1 XII ...Marine Corp« Manpower Requirement« XII -1 ** XIII Air Force Manpower Requirement« XIII-1 : XIV Oefen«e Agency Manpower Requirement« XIV-1 A APPENDICES...adnlnlatratlva poaltlona, tha bulk art aaaoolatad with oparatlonal taaka. \\ 2. Tha following tabla aumarlaaa Padaral Aganoy Support for Rftt-TTt ngtna

  13. Measles and Rubella Immunity: A New Requirement.

    Science.gov (United States)

    Dorman, John M.; And Others

    1984-01-01

    Stanford University (California) has developed a list of medical immunization requirements for incoming students to help stop incidence of rubella and measles. A discussion of these requirements is offered. (DF)

  14. 12 CFR 27.3 - Recordkeeping requirements.

    Science.gov (United States)

    2010-01-01

    ... SYSTEM § 27.3 Recordkeeping requirements. (a) Quarterly recordkeeping requirement. (1) A bank that is... dues or condominium fees, and/or utilities if the bank considers these factors in computing...

  15. 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....

  16. Requirements Engineering for Software Integrity and Safety

    Science.gov (United States)

    Leveson, Nancy G.

    2002-01-01

    Requirements flaws are the most common cause of errors and software-related accidents in operational software. Most aerospace firms list requirements as one of their most important outstanding software development problems and all of the recent, NASA spacecraft losses related to software (including the highly publicized Mars Program failures) can be traced to requirements flaws. In light of these facts, it is surprising that relatively little research is devoted to requirements in contrast with other software engineering topics. The research proposed built on our previous work. including both criteria for determining whether a requirements specification is acceptably complete and a new approach to structuring system specifications called Intent Specifications. This grant was to fund basic research on how these ideas could be extended to leverage innovative approaches to the problems of (1) reducing the impact of changing requirements, (2) finding requirements specification flaws early through formal and informal analysis, and (3) avoiding common flaws entirely through appropriate requirements specification language design.

  17. 49 CFR 172.304 - Marking requirements.

    Science.gov (United States)

    2010-10-01

    ... SECURITY PLANS Marking § 172.304 Marking requirements. (a) The marking required in this subpart— (1) Must... labels or attachments; and (4) Must be located away from any other marking (such as advertising)...

  18. 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.

  19. 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...

  20. 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...

  1. Reserve requirement systems in OECD countries

    OpenAIRE

    Yueh-Yun C. O’Brien

    2007-01-01

    This paper compares the reserve requirements of OECD countries. Reserve requirements are the minimum percentages or amounts of liabilities that depository institutions are required to keep in cash or as deposits with their central banks. To facilitate monetary policy implementation, twenty-four of the thirty OECD countries impose reserve requirements to influence their banking systems’ demand for liquidity. These include twelve OECD countries that are also members of the European Economic and...

  2. Liquidity and reserve requirements in Brazil

    OpenAIRE

    Patrice Robitaille

    2011-01-01

    The international reform initiative that followed the global financial crisis of 2008-09 has resulted in the introduction of liquidity requirements for banks. Under one requirement, the Liquidity Coverage Ratio (LCR), banks will need to hold enough highly liquid assets to survive for a month in a stress scenario. Banks' required reserve balances can be used to fulfill this liquidity requirement and this may be seen as an attractive option for emerging market economies, where financial sectors...

  3. 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...

  4. 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...

  5. 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

  6. 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...

  7. 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...

  8. 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 §...

  9. 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....

  10. 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...

  11. 7 CFR 1770.13 - Accounting requirements.

    Science.gov (United States)

    2010-01-01

    ... 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 of Accounts § 1770.13 Accounting requirements. (a) Each borrower shall maintain its books of accounts on...

  12. 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)....

  13. 7 CFR 51.310 - Packing requirements.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Packing requirements. 51.310 Section 51.310... STANDARDS) United States Standards for Grades of Apples Packing Requirements § 51.310 Packing requirements... the contents. (e) Tolerances: In order to allow for variations incident to proper packing, not...

  14. Administrator Certification Requirements for Student Assessment Competence.

    Science.gov (United States)

    Trevisan, Michael S.

    1999-01-01

    State-level administrator certification requirements were studied with respect to student-assessment expectations, using responses of state certification offices. Only 18 states require some form of student-assessment knowledge and skills, and only Washington state requires the assessment competencies promulgated by the National Policy Board for…

  15. 78 FR 66865 - Interpretation of Rest Requirements

    Science.gov (United States)

    2013-11-07

    ... TRANSPORTATION Federal Aviation Administration 14 CFR Part 135 Interpretation of Rest Requirements AGENCY... application of certain rest requirements during on-demand operations. Section 346 of the FAA Modernization and... finalize the interpretation proposed in Docket No. FAA-2010-1259, relating to rest requirements,...

  16. 75 FR 80746 - Interpretation of Rest Requirements

    Science.gov (United States)

    2010-12-23

    ... Federal Aviation Administration 14 CFR Part 135 Interpretation of Rest Requirements AGENCY: Federal... proposes to interpret the application of 14 CFR 135.263 and the rest requirements of Sec. 135.267(d) to... they will not receive the 10 hours of rest required in a 24-hour period by section...

  17. 24 CFR 92.612 - Project requirements.

    Science.gov (United States)

    2010-04-01

    ... requirements. The following project requirements contained in subpart F of this part apply to the ADDI: (a... layering requirements contained in § 92.250 apply to the total HOME and ADDI funds in a project. (b) Property standards. Housing assisted with ADDI funds must meet the property standards contained in §...

  18. 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..., Preventive Maintenance, and Alterations § 135.427 Manual requirements. (a) Each certificate holder shall put in its manual the chart or description of the certificate holder's organization required by §...

  19. 42 CFR 417.934 - Reserve requirement.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Reserve requirement. 417.934 Section 417.934 Public... PLANS Administration of Outstanding Loans and Loan Guarantees § 417.934 Reserve requirement. (a) Timing... section 1305 of the PHS Act was required to establish a restricted reserve account on the earlier of...

  20. Reserve Requirements and Monetary Management; An Introduction

    OpenAIRE

    International Monetary Fund

    1993-01-01

    Reserve requirements are widely used by central banks as a means to improve monetary control, an instrument for policy implementation, a source of revenue, and a safeguard of bank liquidity. The effectiveness of reserve requirements in fulfilling these functions is reviewed, and the detailed modalities of their use are examined. Reserve requirements in a sample of developing countries are described.

  1. 7 CFR 1942.117 - General requirements.

    Science.gov (United States)

    2010-01-01

    ... § 1942.117 General requirements. (a) Reserve requirements. Loans under this subpart are subject to the... 7 Agriculture 13 2010-01-01 2009-01-01 true General requirements. 1942.117 Section 1942.117 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL...

  2. 49 CFR 383.110 - General requirement.

    Science.gov (United States)

    2010-10-01

    ... STANDARDS; REQUIREMENTS AND PENALTIES Required Knowledge and Skills § 383.110 General requirement. All drivers of commercial motor vehicles shall have knowledge and skills necessary to operate a commercial... may wish to include in the knowledge and skills tests that it administers to CDL applicants...

  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. 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)...

  5. Gamified Requirements Engineering: Model and Experimentation

    NARCIS (Netherlands)

    Lombriser, Philipp; Dalpiaz, Fabiano; Lucassen, Garm; Brinkkemper, Sjaak

    2016-01-01

    [Context & Motivation] Engaging stakeholders in requirements engineering (RE) influences the quality of the requirements and ultimately of the system to-be. Unfortunately, stakeholder engagement is often insufficient, leading to too few, low-quality requirements. [Question/problem] We aim to evaluat

  6. 42 CFR 424.36 - Signature requirements.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Signature requirements. 424.36 Section 424.36... (CONTINUED) MEDICARE PROGRAM CONDITIONS FOR MEDICARE PAYMENT Claims for Payment § 424.36 Signature requirements. (a) General rule. The beneficiary's own signature is required on the claim unless the...

  7. 7 CFR 51.305 - Color requirements.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Color requirements. 51.305 Section 51.305 Agriculture... Standards for Grades of Apples Color Requirements § 51.305 Color requirements. In addition to the... percentage of color specified for the variety in table I appearing in this section. All apple varieties...

  8. 76 FR 50881 - Required Scale Tests

    Science.gov (United States)

    2011-08-17

    ..., Packers and Stockyards Administration 9 CFR Part 201 RIN 0580-AB10 Required Scale Tests AGENCY: Grain... January 20, 2011, and on April 4, 2011, concerning required scale tests. Those documents defined ``limited...), concerning required scale tests. Those documents incorrectly defined limited seasonal basis in Sec....

  9. 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.

  10. 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').

  11. 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.

  12. SIENA Customer Problem Statement and Requirements

    Energy Technology Data Exchange (ETDEWEB)

    L. Sauer; R. Clay; C. Adams; H. Walther; B. Allan; R. Mariano; C. Poore; B. Whiteside; B. Boughton; J. Dike; E. Hoffman; R. Hogan; C. LeGall

    2000-08-01

    This document describes the problem domain and functional requirements of the SIENA framework. The software requirements and system architecture of SIENA are specified in separate documents (called SIENA Software Requirement Specification and SIENA Software Architecture, respectively). While currently this version of the document describes the problems and captures the requirements within the Analysis domain (concentrating on finite element models), it is our intention to subsequent y expand this document to describe problems and capture requirements from the Design and Manufacturing domains. In addition, SIENA is designed to be extendible to support and integrate elements from the other domains (see SIENA Software Architecture document).

  13. Fiscal year 1999 waste information requirements document

    Energy Technology Data Exchange (ETDEWEB)

    Adams, M.R.

    1998-08-10

    The Waste Information Requirements Document (WIRD) has the following purposes: To describe the overall drivers that require characterization information and to document their source; To define how characterization is going to satisfy the drivers, close issues, and measure and report progress; and To describe deliverables and acceptance criteria for characterization. Characterization information is required to maintain regulatory compliance, perform operations and maintenance, resolve safety issues, and prepare for disposal of waste. Commitments addressing these requirements are derived from the Hanford Federal Facility Agreement and Consent Order, also known as the Tri-Party Agreement; the Recommendation 93-5 Implementation Plan (DOE-RL 1996a) to the Defense Nuclear Facilities Safety Board (DNFSB); and other requirement sources listed in Section 2.0. The Waste Information Requirements Document replaces the tank waste analysis plans and the tank characterization plan previously required by the Tri-Party Agreement, Milestone M-44-01 and M-44-02 series.

  14. 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.

  15. TRACER - TRACING AND CONTROL OF ENGINEERING REQUIREMENTS

    Science.gov (United States)

    Turner, P. R.

    1994-01-01

    TRACER (Tracing and Control of Engineering Requirements) is a database/word processing system created to document and maintain the order of both requirements and descriptive material associated with an engineering project. A set of hierarchical documents are normally generated for a project whereby the requirements of the higher level documents levy requirements on the same level or lower level documents. Traditionally, the requirements are handled almost entirely by manual paper methods. The problem with a typical paper system, however, is that requirements written and changed continuously in different areas lead to misunderstandings and noncompliance. The purpose of TRACER is to automate the capture, tracing, reviewing, and managing of requirements for an engineering project. The engineering project still requires communications, negotiations, interactions, and iterations among people and organizations, but TRACER promotes succinct and precise identification and treatment of real requirements separate from the descriptive prose in a document. TRACER permits the documentation of an engineering project's requirements and progress in a logical, controllable, traceable manner. TRACER's attributes include the presentation of current requirements and status from any linked computer terminal and the ability to differentiate headers and descriptive material from the requirements. Related requirements can be linked and traced. The program also enables portions of documents to be printed, individual approval and release of requirements, and the tracing of requirements down into the equipment specification. Requirement "links" can be made "pending" and invisible to others until the pending link is made "binding". Individuals affected by linked requirements can be notified of significant changes with acknowledgement of the changes required. An unlimited number of documents can be created for a project and an ASCII import feature permits existing documents to be incorporated

  16. Virtual phosphorus ore requirement of Japanese economy.

    Science.gov (United States)

    Matsubae, Kazuyo; Kajiyama, Jun; Hiraki, Takehito; Nagasaka, Tetsuya

    2011-08-01

    Phosphorus is indispensable for agricultural production. Hence, the consumption of imported food indirectly implies the import of phosphorus resources. The global consumption of agricultural products depends on a small number of ore-producing countries. For sustainable management of phosphorus resources, the global supply and demand network should be clarified. In this study, we propose the virtual phosphorus ore requirement as a new indicator of the direct and indirect phosphorus requirements for our society. The virtual phosphorus ore requirement indicates the direct and indirect demands for phosphorus ore transformed into agricultural products and fertilizer. In this study, the virtual phosphorus ore requirement was evaluated for the Japanese economy in 2005. Importantly, the results show that our society requires twice as much phosphorus ore as the domestic demand for fertilizer production. The phosphorus contained in "eaten" agricultural products was only 12% of virtual phosphorus ore requirement.

  17. Managing External and Internal Support Requirements

    Science.gov (United States)

    2016-03-14

    stantly must mentally separate the BSB’s brigade combat team (BCT) sustainment requirements from inter- nal BSB logistics requirements. BSBs that fail...and their executive officers (XOs) must then work with the battalion S–4 to coor- dinate movement of additional unit equipment. They must also work ...plained to my team that the proper way to use the HETs for internal transportation requirements was for me or my troop XO to submit a request to the

  18. 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.

  19. Performance Evaluation of Portfolios with Margin Requirements

    OpenAIRE

    Hui Ding; Zhongbao Zhou; Helu Xiao; Chaoqun Ma; Wenbin Liu

    2014-01-01

    In financial markets, short sellers will be required to post margin to cover possible losses in case the prices of the risky assets go up. Only a few studies focus on the optimization and performance evaluation of portfolios in the presence of margin requirements. In this paper, we investigate the theoretical foundation of DEA (data envelopment analysis) approach to evaluate the performance of portfolios with margin requirements from a different perspective. Under the mean-variance framework,...

  20. Required reserves as a credit policy tool

    OpenAIRE

    Mimir, Yasin; Sunel, Enes; Taskin, Temel

    2012-01-01

    This paper conducts a quantitative investigation of the role of reserve requirements as a macroprudential policy tool. We build a monetary DSGE model with a banking sector in which (i) an agency problem between households and banks leads to endogenous capital constraints for banks in obtaining funds from households, (ii) banks are subject to time-varying reserve requirements that countercyclically respond to expected credit growth, (iii) households face cash-in-advance constraints, requiring ...

  1. Program Estimates Areas Required By Electronic Designs

    Science.gov (United States)

    Cox, Brian

    1995-01-01

    PSIZE computer program calculates space required for electronic design. Reads in parts-list file and file containing required area for each type of part. Both unit areas of components and inherent additional space requirements taken into account. Written by use of AWK utility for Sun4-series computers running SunOS 4.x and IBM PC-series and compatible computers running MS-DOS. Sun version (NPO-19589). PC version (NPO-19065).

  2. 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.

  3. 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.

  4. Universal Sensor and Actuator Requirements. Chapter 5

    Science.gov (United States)

    Rosenfeld, Taylor; Webster, John; Garg, Sanjay

    2009-01-01

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

  5. 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.

  6. 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.

  7. 7 CFR 35.11 - Minimum requirements.

    Science.gov (United States)

    2010-01-01

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

  8. Food irradiation facilities: Requirements and technical aspects

    Science.gov (United States)

    Mittendorfer, Josef

    2016-12-01

    This survey presents some aspects and requirement for food irradiation facilities. Topics like radiation source, dose ranges and dose rate are discussed, together with logistics and operational considerations

  9. 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.

  10. 40 CFR 63.1354 - Reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... for Hazardous Air Pollutants From the Portland Cement Manufacturing Industry Notification, Reporting... combustion system component inspections conducted within the reporting period as required under §...

  11. 5 CFR 2504.9 - Identification requirements.

    Science.gov (United States)

    2010-01-01

    ... consulting with the appropriate system manager, may require further reasonable assurances, such as statements... the Privacy Act Officer, after consulting with the appropriate system manager, the granting of...

  12. 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.

  13. 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....

  14. 12 CFR 564.3 - Appraisals required; transactions requiring a State certified or licensed appraiser.

    Science.gov (United States)

    2010-01-01

    ... SUPERVISION, DEPARTMENT OF THE TREASURY APPRAISALS § 564.3 Appraisals required; transactions requiring a State certified or licensed appraiser. (a) Appraisals required. An appraisal performed by a State certified or..., pooled loan, or real property interest met OTS regulatory requirements for appraisals at the time...

  15. 12 CFR 34.43 - Appraisals required; transactions requiring a State certified or licensed appraiser.

    Science.gov (United States)

    2010-01-01

    ..., DEPARTMENT OF THE TREASURY REAL ESTATE LENDING AND APPRAISALS Appraisals § 34.43 Appraisals required; transactions requiring a State certified or licensed appraiser. (a) Appraisals required. An appraisal performed by a State certified or licensed appraiser is required for all real estate-related...

  16. 12 CFR 225.63 - Appraisals required; transactions requiring a State certified or licensed appraiser.

    Science.gov (United States)

    2010-01-01

    ... Appraisals required; transactions requiring a State certified or licensed appraiser. (a) Appraisals required. An appraisal performed by a State certified or licensed appraiser is required for all real estate... or United States government sponsored agency; or (ii) Involves a residential real estate...

  17. 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 requirement...... be a useful contribution both to researchers and practitioners working in the field of requirements reuse. (C) 2014 Elsevier B.V. All rights reserved.......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...... can be drawn directly from the reusable set. However, this is rarely the case in product development as new requirements are likely to surface. A critical issue in requirements reuse therefore becomes how to enable products to efficiently reuse requirements as well incorporating changes to the product...

  18. 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...

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

    Energy Technology Data Exchange (ETDEWEB)

    JOHNSON, A.L.

    2000-11-30

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

  20. 7 CFR 3565.255 - Environmental requirements.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE GUARANTEED RURAL RENTAL HOUSING PROGRAM Property Requirements § 3565.255 Environmental... impact of the proposed actions on protected environmental resources. Measures to avoid or at least... 7 Agriculture 15 2010-01-01 2010-01-01 false Environmental requirements. 3565.255 Section...

  1. 7 CFR 3560.3 - Environmental requirements.

    Science.gov (United States)

    2010-01-01

    ... Environmental requirements. RHS will consider environmental impacts of proposed housing as equal with economic... 7 Agriculture 15 2010-01-01 2010-01-01 false Environmental requirements. 3560.3 Section 3560.3 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, DEPARTMENT...

  2. Advanced Extravehicular Activity Pressure Garment Requirements Development

    Science.gov (United States)

    Ross, Amy

    2014-01-01

    The NASA Johnson Space Center advanced pressure garment technology development team is addressing requirements development for exploration missions. Lessons learned from the Z-2 high fidelity prototype development have reiterated that clear low-level requirements and verification methods reduce risk to the government, improve efficiency in pressure garment design efforts, and enable the government to be a smart buyer. The expectation is to provide requirements at the specification level that are validated so that their impact on pressure garment design is understood. Additionally, the team will provide defined verification protocols for the requirements. However, in reviewing exploration space suit high level requirements there are several gaps in the team's ability to define and verify related lower level requirements. This paper addresses the efforts in requirement areas such as mobility/fit/comfort and environmental protection (dust, radiation, plasma, secondary impacts) to determine the by what method the requirements can be defined and use of those methods for verification. Gaps exist at various stages. In some cases component level work is underway, but no system level effort has begun, in other cases no effort has been initiated to close the gap. Status of ongoing efforts and potential approaches to open gaps are discussed.

  3. 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.

  4. 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...

  5. 14 CFR 65.55 - Knowledge requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Knowledge requirements. 65.55 Section 65.55... CERTIFICATION: AIRMEN OTHER THAN FLIGHT CREWMEMBERS Aircraft Dispatchers § 65.55 Knowledge requirements. (a) A person who applies for an aircraft dispatcher certificate must pass a knowledge test on the...

  6. 14 CFR 63.35 - Knowledge requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Knowledge requirements. 63.35 Section 63.35 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN CERTIFICATION: FLIGHT CREWMEMBERS OTHER THAN PILOTS Flight Engineers § 63.35 Knowledge requirements. (a)...

  7. 14 CFR 63.53 - Knowledge requirements.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Knowledge requirements. 63.53 Section 63.53 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN CERTIFICATION: FLIGHT CREWMEMBERS OTHER THAN PILOTS Flight Navigators § 63.53 Knowledge requirements. (a)...

  8. 40 CFR 141.130 - General requirements.

    Science.gov (United States)

    2010-07-01

    ... treatment technique requirements for disinfection byproduct precursors in § 141.135. (2) The regulations in... established MCLs for TTHM and HAA5 and treatment technique requirements for disinfection byproduct precursors..., distribution line breaks, storm run-off events, source water contamination events, or cross-connection events....

  9. 24 CFR 886.327 - Lease requirements.

    Science.gov (United States)

    2010-04-01

    ... 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) The term of a lease, including a new lease or a lease amendment, executed by the owner and the family...

  10. 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...

  11. 24 CFR 891.425 - Lease requirements.

    Science.gov (United States)

    2010-04-01

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

  12. 24 CFR 886.127 - Lease requirements.

    Science.gov (United States)

    2010-04-01

    ... 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 lease. (1) The term of a lease, including a new lease or a lease amendment, executed by the owner and...

  13. 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...

  14. 31 CFR 103.28 - Identification required.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Identification required. 103.28 Section 103.28 Money and Finance: Treasury Regulations Relating to Money and Finance FINANCIAL RECORDKEEPING AND REPORTING OF CURRENCY AND FOREIGN TRANSACTIONS Reports Required To Be Made §...

  15. 7 CFR 1709.12 - Reporting requirements.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE ASSISTANCE TO HIGH ENERGY COST COMMUNITIES General Requirements § 1709.12 Reporting requirements... follows: (a) A financial status report listing project expenditures by budget category in such form and at... grant agreement is not being met, the report should discuss the problems or delays that may...

  16. Regulatory capital requirements and bail in mechanisms

    NARCIS (Netherlands)

    Joosen, B.P.M.; Haentjens, M.; Wessels, B.

    2015-01-01

    With the introduction of the Capital Requirements Regulation (CRR) in the European Union, the qualitative requirements for bank regulatory capital have changed. These changes aim at implementing in Europe the Basel III principles for better bank capital that is able to absorb losses of banks, withou

  17. 47 CFR 80.861 - Required capacity.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Required capacity. 80.861 Section 80.861... Required capacity. If the main power supply or the reserve power supply provided for the purpose of... capacity available at all times while the vessel is leaving or attempting to leave a harbor or port for...

  18. 47 CFR 80.919 - Required capacity.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Required capacity. 80.919 Section 80.919... capacity. If either the main or reserve power supply includes batteries, these batteries must have sufficient reserve capacity to permit proper operation of the required transmitter and receiver for at...

  19. 24 CFR 884.215 - Lease requirements.

    Science.gov (United States)

    2010-04-01

    ... which fall within the classifications listed below shall not be included in any Lease. (1) Confession of... 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...

  20. 77 FR 16768 - Export Sales Reporting Requirements

    Science.gov (United States)

    2012-03-22

    ... Office of the Secretary 7 CFR Part 20 RIN 0551-AA70 Export Sales Reporting Requirements AGENCY: Office of... frozen box/primal cuts) and distillers dried grain (DDG) to the Export Sales Reporting Requirements, is..., Branch Chief, Export Sales Reporting Branch, Import Policies and Export Reporting Division, Office...

  1. 7 CFR 3565.103 - Approval requirements.

    Science.gov (United States)

    2010-01-01

    ... lender must provide the Agency with an annual audited financial statement conducted in accordance with... reserves, to have an acceptable level of financial soundness as determined by a lender rating service (such... AGRICULTURE GUARANTEED RURAL RENTAL HOUSING PROGRAM Lender Requirements § 3565.103 Approval requirements....

  2. 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…

  3. 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... § 121.369 Manual requirements. (a) The certificate holder shall put in its manual a chart or description..., or alterations, including a general description of that work. (b) The certificate holder's...

  4. 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...

  5. 42 CFR 422.100 - General requirements.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false General requirements. 422.100 Section 422.100... General requirements. (a) Basic rule. Subject to the conditions and limitations set forth in this subpart... services. (g) Benefits affecting screening mammography, influenza vaccine, and pneumoccal vaccine....

  6. 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 §...

  7. 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...

  8. 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...

  9. 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...

  10. 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

  11. 10 CFR 61.3 - License required.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false License required. 61.3 Section 61.3 Energy NUCLEAR... Provisions § 61.3 License required. (a) No person may receive, possess, and dispose of radioactive waste... license issued by the Commission pursuant to this part, or unless exemption has been granted by...

  12. 10 CFR 60.3 - License required.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false License required. 60.3 Section 60.3 Energy NUCLEAR... Provisions § 60.3 License required. (a) DOE shall not receive or possess source, special nuclear, or byproduct material at a geologic repository operations area except as authorized by a license issued by...

  13. 10 CFR 70.3 - License requirements.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false License requirements. 70.3 Section 70.3 Energy NUCLEAR... License requirements. No person subject to the regulations in this part shall receive title to, own... license issued by the Commission pursuant to these regulations....

  14. 10 CFR 35.11 - License required.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false License required. 35.11 Section 35.11 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.11 License required. (a) A... for medical use only in accordance with a specific license issued by the Commission or an...

  15. 19 CFR 112.21 - License required.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 1 2010-04-01 2010-04-01 false License required. 112.21 Section 112.21 Customs... CARRIERS, CARTMEN, AND LIGHTERMEN Licensing of Cartmen and Lightermen § 112.21 License required. A customhouse cartage or lighterage license issued by the port director in accordance with this part or...

  16. 10 CFR 40.3 - License requirements.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false License requirements. 40.3 Section 40.3 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF SOURCE MATERIAL General Provisions § 40.3 License requirements. A..., unless authorized in a specific or general license issued by the Commission under the regulations in...

  17. 10 CFR 63.3 - License required.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false License required. 63.3 Section 63.3 Energy NUCLEAR... MOUNTAIN, NEVADA General Provisions § 63.3 License required. (a) DOE may not receive nor possess source... except as authorized by a license issued by the Commission under this part. (b) DOE may not...

  18. 10 CFR 55.3 - License requirements.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false License requirements. 55.3 Section 55.3 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) OPERATORS' LICENSES General Provisions § 55.3 License requirements. A person must be authorized by a license issued by the Commission to perform the function of an operator...

  19. 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...

  20. 45 CFR 164.314 - Organizational requirements.

    Science.gov (United States)

    2010-10-01

    ... the objectives of paragraph (a)(2)(i) of this section. (B) If a business associate is required by law... Information § 164.314 Organizational requirements. (a)(1) Standard: Business associate contracts or other arrangements. (i) The contract or other arrangement between the covered entity and its business...

  1. 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...

  2. 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...

  3. 40 CFR 141.80 - General requirements.

    Science.gov (United States)

    2010-07-01

    ... exceeding the lead or copper action level shall implement all applicable source water treatment requirements...) NATIONAL PRIMARY DRINKING WATER REGULATIONS Control of Lead and Copper § 141.80 General requirements. (a... drinking water regulations for lead and copper. Unless otherwise indicated, each of the provisions of...

  4. 49 CFR 230.86 - Required illumination.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Required illumination. 230.86 Section 230.86... Tenders Cabs, Warning Signals, Sanders and Lights § 230.86 Required illumination. (a) General provisions... provides illumination sufficient for a steam locomotive engineer in the cab to see, in a clear...

  5. 40 CFR 433.12 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... requirements. (a) In lieu of requiring monitoring for TTO, the permitting authority (or, in the case of... the permit limitation for total toxic organics (TTO), I certify that, to the best of my knowledge and... TTO standard, the industrial discharger need analyse for only those pollutants which would...

  6. 46 CFR 108.213 - Heating requirements.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Heating requirements. 108.213 Section 108.213 Shipping... EQUIPMENT Construction and Arrangement Accommodation Spaces § 108.213 Heating requirements. (a) Each accommodation space must be heated by a heating system that can maintain at least 20°C. (68°F.). (b)...

  7. 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....

  8. 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...

  9. Requirements engineering: problem analysis and solution specification

    NARCIS (Netherlands)

    Wieringa, R.J.; Koch, N.; Fraternali, P.; Wirsing, M.

    2004-01-01

    Taken literally, the term requirements engineering (RE) is a misnomer. A requirement is something that is wanted; engineering, according to Websters, is calculated manipulation. If our wants would arise by calculated manipulation, then something would be wrong. Our wants should not be engineered. Wh

  10. 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...

  11. 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…

  12. 15 CFR 806.4 - Response required.

    Science.gov (United States)

    2010-01-01

    ... ECONOMIC ANALYSIS, DEPARTMENT OF COMMERCE DIRECT INVESTMENT SURVEYS § 806.4 Response required. Reports, as... certifying in writing to the fact that the person has no direct investments within the purview of the Act or... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Response required. 806.4 Section...

  13. Meeting Ecologists Requirements with Adaptive Data Acquisition

    DEFF Research Database (Denmark)

    Chang, Marcus; Bonnet, Philippe

    their potential if they meet the scientists requirements. In an ideal world, an ecologist expresses requirements in terms of a target dataset, which the sensor network then actually collects and stores. In fact, failures occur and interesting events happen making uniform, systematic ecosys- tem sampling neither...

  14. 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....

  15. An Online Graduate Requirements Engineering Course

    Science.gov (United States)

    Kilicay-Ergin, N.; Laplante, P. A.

    2013-01-01

    Requirements engineering is one of the fundamental knowledge areas in software and systems engineering graduate curricula. Recent changes in educational delivery and student demographics have created new challenges for requirements engineering education. In particular, there is an increasing demand for online education for working professionals.…

  16. Tracing And Control Of Engineering Requirements

    Science.gov (United States)

    Turner, Philip R.; Stoller, Richard L.; Neville, Ted; Boyle, Karen A.

    1991-01-01

    TRACER (Tracing and Control of Engineering Requirements) is data-base/word-processing software system created to document and maintain order of both requirements and descriptions associated with engineering project. Implemented on IBM PC under PC-DOS. Written with CLIPPER.

  17. Modeling uncertainty in requirements engineering decision support

    Science.gov (United States)

    Feather, Martin S.; Maynard-Zhang, Pedrito; Kiper, James D.

    2005-01-01

    One inherent characteristic of requrements engineering is a lack of certainty during this early phase of a project. Nevertheless, decisions about requirements must be made in spite of this uncertainty. Here we describe the context in which we are exploring this, and some initial work to support elicitation of uncertain requirements, and to deal with the combination of such information from multiple stakeholders.

  18. 45 CFR 1328.19 - Application requirements.

    Science.gov (United States)

    2010-10-01

    ... SUPPORTIVE AND NUTRITIONAL SERVICES TO OLDER HAWAIIAN NATIVES § 1328.19 Application requirements. To receive... Hawaiian natives in close coordination with the State agency and Area Agency on Aging: (3) The eligible organization shall comply with all applicable State and local license and safety requirements for the...

  19. 12 CFR 616.6800 - Disclosure requirements.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Disclosure requirements. 616.6800 Section 616.6800 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM LEASING § 616.6800 Disclosure requirements. (a) Each System institution must give to each lessee a copy of all lease documents signed by...

  20. 12 CFR 618.8020 - Feasibility requirements.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Feasibility requirements. 618.8020 Section 618.8020 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM GENERAL PROVISIONS Related Services § 618.8020 Feasibility requirements. For every related service program a System bank...

  1. 12 CFR 725.19 - Collateral requirements.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Collateral requirements. 725.19 Section 725.19 Banks and Banking NATIONAL CREDIT UNION ADMINISTRATION REGULATIONS AFFECTING CREDIT UNIONS NATIONAL CREDIT UNION ADMINISTRATION CENTRAL LIQUIDITY FACILITY § 725.19 Collateral requirements. (a)...

  2. 12 CFR 370.9 - Recordkeeping requirements.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Recordkeeping requirements. 370.9 Section 370.9 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION REGULATIONS AND STATEMENTS OF GENERAL POLICY TEMPORARY LIQUIDITY GUARANTEE PROGRAM § 370.9 Recordkeeping requirements. The FDIC will establish...

  3. 7 CFR 58.446 - Quality requirements.

    Science.gov (United States)

    2010-01-01

    ..., Emmentaler Cheese. (e) Bulk American cheese for manufacturing. The quality requirements for bulk American cheese for manufacturing shall be in accordance with the U.S. Standards for Grades of Bulk American... Products Bearing Usda Official Identification § 58.446 Quality requirements. (a) Cheddar cheese....

  4. Security Requirements – Analysis of the Issue

    Directory of Open Access Journals (Sweden)

    Jhon Vincent

    2013-12-01

    Full Text Available Needs about security are matters little taken into account when managing requirements engineering , and when considered in the life cycle of the system , they tend to become a general list of functions, as password of protection , firewalls , virus detection tools , and other similar. But in fact, they cannot be considered as requirements of security, because they are implementation mechanisms to try to meet unspecified requirements, as an authenticated access. As a result, the security requirements for the system are ignored, which are required to protect essential services and assets, besides, when are specified, is not considered the prospect of future attacks. This paper describes the need for a systematic approach to managing security requirements engineering, in order to help avoid the problem of generic lists and take into account the future perspective. Several related approaches are described and also are provided references additional material that can help requirements engineers to ensure that their products be taken into account, effectively , the security requirements.

  5. 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...

  6. 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...

  7. 32 CFR 169a.21 - Reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... ACTIVITIES PROGRAM PROCEDURES Reporting Requirements § 169a.21 Reporting requirements. (a) Inventory and... Activities Management Information System (CAMIS) (Report Control Symbol DD-A&T(Q) 1542). (1) The purpose of... Accounting Office (GAO), OSD, and others. The CAMIS is divided into two parts. Part I contains data on...

  8. 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.

  9. Margin Requirements and Equity Option Returns

    DEFF Research Database (Denmark)

    Hitzemann, Steffen; Hofmann, Michael; Uhrig-Homburg, Marliese

    In equity option markets, traders face margin requirements both for the options themselves and for hedging-related positions in the underlying stock market. We show that these requirements carry a significant margin premium in the cross-section of equity option returns. The sign of the margin pre...

  10. 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)...

  11. 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...

  12. 34 CFR 686.32 - Counseling requirements.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false Counseling requirements. 686.32 Section 686.32...) GRANT PROGRAM Administration of Grant Payments § 686.32 Counseling requirements. (a) Initial counseling. (1) An institution must ensure that initial counseling is conducted with each TEACH Grant...

  13. 32 CFR 34.31 - Requirements.

    Science.gov (United States)

    2010-07-01

    ... breaches the contract terms, and provide for such remedial actions as may be appropriate. (2) All contracts... procurements. Prior to awarding a procurement contract under an award, a recipient may be required to provide... include a provision in the award that states the requirement. (c) Contract provisions. (1) Contracts...

  14. 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...

  15. 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.

  16. 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.

  17. Performance Evaluation of Portfolios with Margin Requirements

    Directory of Open Access Journals (Sweden)

    Hui Ding

    2014-01-01

    Full Text Available In financial markets, short sellers will be required to post margin to cover possible losses in case the prices of the risky assets go up. Only a few studies focus on the optimization and performance evaluation of portfolios in the presence of margin requirements. In this paper, we investigate the theoretical foundation of DEA (data envelopment analysis approach to evaluate the performance of portfolios with margin requirements from a different perspective. Under the mean-variance framework, we construct the optimization model and portfolio possibility set on considering margin requirements. The convexity of the portfolio possibility set is proved and the concept of efficiency in classical economics is extended to the portfolio case. The DEA models are then developed to evaluate the performance of portfolios with margin requirements. Through the simulations carried out in the end, we show that, with adequate portfolios, DEA can be used as an effective tool in computing the efficiencies of portfolios with margin requirements for the performance evaluation purpose. This study can be viewed as a justification of DEA into performance evaluation of portfolios with margin requirements.

  18. Are functional foods redefining nutritional requirements?

    Science.gov (United States)

    Jones, Peter J; Varady, Krista A

    2008-02-01

    Functional foods are increasing in popularity owing to their ability to confer health and physiological benefits. Nevertheless, the notion that functional foods improve health when providing nutrients at levels above and beyond existing recommended intakes is inconsistent with the definition of requirement. This disparity highlights the need for an alternative definition of nutrient requirement. The present objective is to examine distinctions between optimization of health, as defined by what we currently deem as required intakes, versus adding physiological benefit using bioactive agents found in functional foods. Presently, requirement is defined as the lowest amount of intake of a nutrient that will maintain a defined level of nourishment for a specific indicator of adequacy. In contrast, functional foods are described as ingredients that are not necessary for body function, yet provide added physiological benefit that confer better overall health. Plant sterols are one example of such an ingredient. Plant sterols lower plasma cholesterol concentrations, and may thus be considered essential nutrients in physiological situations where circulating cholesterol concentrations are high. Similarly, intakes of omega-3 fats beyond existing requirement may confer additional health benefits such as hypolipidemic and anti-diabetic effects. These examples underscore the inconsistencies between what is defined as a nutrient requirement versus what is identified as a health benefit of a functional food. Such discrepancies emphasize the need for a more all-encompassing definition of a nutrient requirement; that is, one that moves beyond the prevention of overt deficiency to encompass improved health and disease risk reduction.

  19. Optical manufacturing requirements for an AVLIS plant

    Energy Technology Data Exchange (ETDEWEB)

    Primdahl, K.; Chow, R.; Taylor, J.R.

    1997-07-14

    A uranium enrichment plant utilizing Atomic Vapor Laser Isotope Separation (AVLIS) 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.

  20. 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.

  1. 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...... system operation as well as experiences and results from other European projects. On the other hand, it analyses what requirements for future control rooms arise from the ELECTRA proposed control solutions. Hence, different points of view are taken into account. The ELECTRA Use Cases (UCs...

  2. 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.

  3. Data requirements and acquisition for reservoir characterization

    Energy Technology Data Exchange (ETDEWEB)

    Jackson, S.; Chang, Ming Ming; Tham, Min.

    1993-03-01

    This report outlines the types of data, data sources and measurement tools required for effective reservoir characterization, the data required for specific enhanced oil recovery (EOR) processes, and a discussion on the determination of the optimum data density for reservoir characterization and reservoir modeling. The two basic sources of data for reservoir characterization are data from the specific reservoir and data from analog reservoirs, outcrops, and modern environments. Reservoir data can be divided into three broad categories: (1) rock properties (the container) and (2) fluid properties (the contents) and (3)interaction between reservoir rock and fluid. Both static and dynamic measurements are required.

  4. 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...

  5. 40 CFR 63.624 - Operating requirements.

    Science.gov (United States)

    2010-07-01

    ... Emission Standards for Hazardous Air Pollutants From Phosphate Fertilizers Production Plants § 63.624... scrubbing liquid to each scrubber within the allowable ranges established pursuant to the requirements...

  6. 9 CFR 381.36 - Facilities required.

    Science.gov (United States)

    2010-01-01

    ... automatically with a sufficient volume of water to remove all fat, tissue, debris, and other extraneous material... surfaces. 1 This requirement may be met by deluxe cool white type of fluorescent lighting. (ix)...

  7. 7 CFR 926.17 - Reporting requirements.

    Science.gov (United States)

    2010-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE DATA COLLECTION, REPORTING AND RECORDKEEPING REQUIREMENTS APPLICABLE TO CRANBERRIES NOT SUBJECT TO THE CRANBERRY MARKETING ORDER §...

  8. 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...

  9. 48 CFR 23.905 - Requirements.

    Science.gov (United States)

    2010-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contractor Compliance With Toxic Chemical Release Reporting 23.905 Requirements. (a... Classification (SIC) codes or their corresponding North American Industry Classification System sectors:...

  10. 40 CFR 63.807 - Reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... Emission Standards for Wood Furniture Manufacturing Operations § 63.807 Reporting requirements. (a) The... months of wood furniture manufacturing operations: (1) The first report shall be submitted 30...

  11. 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.

  12. Vacancy Duration, Wage Offers, and Job Requirements

    DEFF Research Database (Denmark)

    Eriksson, Tor Viking; Chen, Long-Hwa

    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...... 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...... 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...

  13. 49 CFR 172.704 - Training requirements.

    Science.gov (United States)

    2010-10-01

    ... awareness/familiarization training designed to provide familiarity with the requirements of this subchapter... component covering how to recognize and respond to possible security threats. After March 25, 2003,...

  14. 42 CFR 489.10 - Basic requirements.

    Science.gov (United States)

    2010-10-01

    ... that no person in the United States shall, on the ground of race, color, or national origin, be... requirements of the Office of Civil Rights of HHS. (c) In order for a hospital, SNF, HHA, hospice, or RNHCI...

  15. 49 CFR 177.834 - General requirements.

    Science.gov (United States)

    2010-10-01

    ... requirements is met: (1) Electrical apparatus in the cargo compartment is nonsparking or explosion proof. (2... from the cargo compartment to the combustion apparatus. (4) The heating system will not heat any...

  16. 7 CFR 1470.6 - Eligibility requirements.

    Science.gov (United States)

    2010-01-01

    ...) Be in compliance with the highly erodible land and wetland conservation provisions found at 7 CFR... OF AGRICULTURE LOANS, PURCHASES, AND OTHER OPERATIONS CONSERVATION STEWARDSHIP PROGRAM General... limited to, information related to eligibility requirements and ranking factors; conservation activity...

  17. Change in requirements during the design process

    DEFF Research Database (Denmark)

    Sudin, Mohd Nizam Bin; Ahmed-Kristensen, Saeema

    2011-01-01

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

  18. 32 CFR 169a.12 - New requirements.

    Science.gov (United States)

    2010-07-01

    ... of new requirements involving a capital investment of $500,000 or more will not be redelegated below the level of DAS or equivalent. (e) Approval to budget for a major capital investment associated...

  19. Risk Management Practices and Accounting Requirements.

    Science.gov (United States)

    Cheng, Rita Hartung; Yahr, Robert B.

    1989-01-01

    Reviews current school district risk management practices and the related accounting requirements. Summarizes the Governmental Accounting Standards Board's proposed accounting standards and the impact of these on school districts' risk management practices and on their financial statements. (11 references) (MLF)

  20. 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.

  1. 14 CFR 65.79 - Skill requirements.

    Science.gov (United States)

    2010-01-01

    ... CERTIFICATION: AIRMEN OTHER THAN FLIGHT CREWMEMBERS Mechanics § 65.79 Skill requirements. Each applicant for a mechanic certificate or rating must pass an oral and a practical test on the rating he seeks. The...

  2. 42 CFR 455.230 - Eligibility requirements.

    Science.gov (United States)

    2010-10-01

    ... Eligibility requirements. CMS may enter into a contract with an entity to perform the activities described at... in relation to Title XIX of the Social Security Act and in other cases arising out of such...

  3. 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...

  4. Radiation Belt and Plasma Model Requirements

    Science.gov (United States)

    Barth, Janet L.

    2005-01-01

    Contents include the following: Radiation belt and plasma model environment. Environment hazards for systems and humans. Need for new models. How models are used. Model requirements. How can space weather community help?

  5. 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,

  6. 38 CFR 36.4704 - Escrow requirement.

    Science.gov (United States)

    2010-07-01

    ...) LOAN GUARANTY Sale of Loans, Guarantee of Payment, and Flood Insurance § 36.4704 Escrow requirement. If... secured by residential improved real estate or a mobile home that is made, increased, extended, or...

  7. 40 CFR 141.70 - General requirements.

    Science.gov (United States)

    2010-07-01

    ... technique requirements in lieu of maximum contaminant levels for the following contaminants: Giardia lamblia... achieve: (1) At least 99.9 percent (3-log) removal and/or inactivation of Giardia lamblia cysts between...

  8. 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...

  9. 42 CFR 431.703 - Licensing requirement.

    Science.gov (United States)

    2010-10-01

    ... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS STATE ORGANIZATION AND GENERAL ADMINISTRATION State Programs for Licensing Nursing Home Administrators § 431.703 Licensing requirement. The State licensing program must provide that only nursing homes supervised by an administrator licensed in accordance with...

  10. Front Loaded Accurate Requirements Engineering (FLARE): a requirements analysis concept for the 21st century

    OpenAIRE

    Leonard, Anthony E

    1997-01-01

    Approved for public release; distribution is unlimited This thesis focuses on ways to apply requirements engineering techniques and methods during the development and evolution of DoD software systems in an effort to reduce changes to system requirements. The major goal of this thesis is to provide a feasible course of action (COA) that reduces changes to requirements caused by the turnover of DoD decision-makers. We demonstrate a distributed requirements engineering environment using comp...

  11. 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

  12. Homology requirements for recombination in Escherichia coli.

    OpenAIRE

    Watt, V M; Ingles, C J; Urdea, M S; Rutter, W J

    1985-01-01

    The DNA sequence homology required for recombination in Escherichia coli has been determined by measuring the recombination frequency between insulin DNA in a miniplasmid pi VX and a homologous sequence in a bacteriophage lambda vector. A minimum of approximately equal to 20 base pairs in a completely homologous segment is required for significant recombination. There is an exponential increase in the frequency of recombination when the length of homologous DNA is increased from 20 base pairs...

  13. 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.

  14. 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.

  15. 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....

  16. 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.

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

    Science.gov (United States)

    2013-12-26

    ..., non-Federal entities have faced risks of more restrictive oversight and audit findings that stem from.... Targeting Audit Requirements on Risk of Waste, Fraud, and Abuse: The final guidance right-sizes the.... Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards;...

  18. 32 CFR 37.670 - Must I require participants to flow down audit requirements to subrecipients?

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 1 2010-07-01 2010-07-01 false Must I require participants to flow down audit... Affecting Participants' Financial, Property, and Purchasing Systems Financial Matters § 37.670 Must I require participants to flow down audit requirements to subrecipients? (a) Yes, in accordance with §...

  19. [Post-marketing surveillance of Tanreqing injection in children: a real world study].

    Science.gov (United States)

    Li, X X; Zhuo, L; Yang, Y H; Zhan, S Y; Zhai, S D

    2017-02-10

    Objective: To evaluate the safety of Tanreqing injection among children in the real world. Methods: A multicenter, large sample, ambispective cohort study, with registration-type clinical safety monitoring. A total of 6 188 inpatients and patients from the emergency units, aged ≤ 14 years who all had been using Tanreqing injection in 59 secondary and tertiary hospitals in China, were recruited between January, 2014 and May, 2015. The main outcomes would include incidence and severity of adverse drug reaction (ADR)/adverse drug event (ADE) of Tanreqing injection. Univariate analysis was used to explain the risk factors of ADR. Results: The overall incidence of ADE was 4.20‰ (26 cases), including 4 serious ones. The incidence of ADR was 3.07‰ (19 cases), including 17 cases of general ADR and 2 cases of new ADR. All the ADR cases were mild or moderate, mostly showing damages in skin and appendages. The onset of disease happened in 24 hours after the Tanreqing injection but all the ADR cases got improved or cured. Having histories of allergies to drugs or foods would increase the incidence of ADR. Conclusion:Tanreqing injection caused low incidence of ADR in children. Progams as stratifying high-risk patients and improving administrative management could further increase the safety level of Tanreqing injection.

  20. Effectiveness and safety of dydrogesterone in regularization of menstrual cycle: a post-marketing study.

    Science.gov (United States)

    Trivedi, Nilesh; Chauhan, Naveen; Vaidya, Vishal

    2016-08-01

    Oral administration of dydrogesterone during second half of menstrual cycle has been shown to reduce menstrual irregularities. This prospective, observational study aimed to determine continued effectiveness of dydrogesterone (prescribed between 1 and 6 cycles or longer) in menstrual cycle regularization in Indian women aged ≥18 years with irregular menstrual cycle for at least 3 months. Those achieving regular cycles (21 to 35 days, inclusive) during treatment were followed up for 6 months after cessation of dydrogesterone treatment. Of the 910 women completing dydrogesterone treatment, 880 (96.7%) achieved cycle regularization (pevent (appendicitis) and three non-serious adverse events were reported. Dydrogesterone regularizes and improves the duration of the menstrual cycle, reduces the amount of bleeding, relieves menstrual pain and prevents relapse of irregular cycles at six months after discontinuation of treatment.

  1. Safety of measles-containing vaccines in post-marketing surveillance in Anhui, China

    Science.gov (United States)

    Meng, Fan-Ya; Sun, Yong; Shen, Yong-Gang; Pan, Hai-Feng; Tang, Ji-Hai; Wang, Bin-Bing; Wu, Chang-Hao; Ye, Dong-Qing

    2017-01-01

    The safety of measles vaccination is of great interest and importance to public health practice and the general society. We have analyzed the adverse events following immunization (AEFIs) of currently used measles-containing vaccines (including live attenuated measles vaccine, live attenuated measles and rubella combined vaccine, live attenuated measles and mumps combined vaccine, live attenuated Measles, Mumps and Rubella Combined Vaccine) in Anhui Province, China. From 2009 to 2014, 9.9 million doses of measles-containing vaccines were administrated and 1893 AEFIs were found (191.4 per million doses), of which, 33 serious AEFIs (3.3 per million vaccine doses) were reported. 59.4% (1124 cases) were male cases, and 85.1% (1611 cases) occurred in persons aged < 1 year. 93.3% (1766 cases) occurred at the first dose of vaccination and 95.9% (1815 cases) were found within 3 days after vaccination. This study presents up-to-date data and suggests that the measles-containing vaccines used in Anhui Province of China are safe. PMID:28192490

  2. Safety of measles-containing vaccines in post-marketing surveillance in Anhui, China.

    Science.gov (United States)

    Meng, Fan-Ya; Sun, Yong; Shen, Yong-Gang; Pan, Hai-Feng; Tang, Ji-Hai; Wang, Bin-Bing; Wu, Chang-Hao; Ye, Dong-Qing

    2017-01-01

    The safety of measles vaccination is of great interest and importance to public health practice and the general society. We have analyzed the adverse events following immunization (AEFIs) of currently used measles-containing vaccines (including live attenuated measles vaccine, live attenuated measles and rubella combined vaccine, live attenuated measles and mumps combined vaccine, live attenuated Measles, Mumps and Rubella Combined Vaccine) in Anhui Province, China. From 2009 to 2014, 9.9 million doses of measles-containing vaccines were administrated and 1893 AEFIs were found (191.4 per million doses), of which, 33 serious AEFIs (3.3 per million vaccine doses) were reported. 59.4% (1124 cases) were male cases, and 85.1% (1611 cases) occurred in persons aged < 1 year. 93.3% (1766 cases) occurred at the first dose of vaccination and 95.9% (1815 cases) were found within 3 days after vaccination. This study presents up-to-date data and suggests that the measles-containing vaccines used in Anhui Province of China are safe.

  3. Postmarketing surveillance of proton pump inhibitors in perspective: the case of Lansoprazole

    NARCIS (Netherlands)

    Bodewes-Claessens, A. (Angela)

    2001-01-01

    The series of studies captured in this thesis have one common source, a prospective, open label, follow-up study to evaluate patterns of use, safety and effectiveness of the PPI lansoprazole in 10,008 naturally occurring patients in the Netherlands (1994-1998). Clinical record forms and medicatio

  4. 76 FR 43691 - Unique Device Identification for Postmarket Surveillance and Enforcement; Public Workshop

    Science.gov (United States)

    2011-07-21

    ... Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, Bethesda, MD 20852; 301-822-9200... workshop will be provided beginning at 11 a.m. Hotel reservations can be made by calling the hotel...

  5. 21 CFR 601.28 - Annual reports of postmarketing pediatric studies.

    Science.gov (United States)

    2010-04-01

    ..., Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research... population (neonates, infants, children, and adolescents) shall be provided, including dosage form....

  6. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Science.gov (United States)

    2011-01-07

    .... Regarding dietary supplements: John Sheehan, Center for Food Safety and Applied Nutrition (HFS-315), Food... Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360bbb- 3). This draft guidance also...

  7. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Science.gov (United States)

    2010-04-01

    ... FDA Form 3500A (Adverse Reaction Report) for each adverse drug experience not reported under paragraph... resubmit to FDA adverse drug experience reports forwarded to the applicant by FDA; however, applicants must... applicant shall report to FDA adverse drug experience information, as described in this......

  8. 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.

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

    OpenAIRE

    Chung-Khain Wye; Rahmah Ismail

    2012-01-01

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

  10. 78 FR 20926 - Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International...

    Science.gov (United States)

    2013-04-08

    ... Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk... its waiver authority to permit applicants to submit an International Conference on Harmonisation...

  11. A postmarketing surveillance study of dexrabeprazole in the treatment of acid peptic disorders.

    Science.gov (United States)

    Jain, S C

    2009-02-01

    Dexrabeprazole [R(+) rabeprazole] is a novel proton-pump inhibitor which has recently become available in India for the treatment of acid peptic diseases. Experimental and clinical studies have shown superiority of dexrabeprazole (at half the recommended rabeprazole dose) over rabeprazole in terms of favourable pharmacokinetics, better efficacy and faster and greater healing activity. Results of present study in a large population of 4931 patients of acid peptic disorders, reconfirmed safety and efficacy of dexrabeprazole 10 mg once daily in the treatment of gastro-oesophageal reflux disease and also showed its effectiveness in the treatment of patients with peptic ulcers (gastric/duodenal).

  12. [Literature review of post-marketing clinical evaluation of Xiaoke pill].

    Science.gov (United States)

    Liu, Huan; Xie, Yanming

    2011-10-01

    The literatures of clinical application showed that Xiaoke pill has exact effect on type 2 diabetes. Because Xiaoke pills contain glyburide, most adverse reactions are resulted from inappropriate use. Clinical scientific and medical treatment can be guided by strengthening the mission, improving the instructions of medicines, improving pharmaceutical production technology, strengthening clinical research to further explore the relationship between blood glucose levels and dose, and clearing indications and contraindications. These also can improve security together with the good economy, and will benefit the sustainable development of Xiaoke pill.

  13. 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

  14. 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.

  15. Response requirements as constraints on output.

    Science.gov (United States)

    Zeiler, M D; Buchman, I B

    1979-07-01

    Two experiments studied how added response requirements affected fixed-interval schedule performance. Experiment 1 involved tandem fixed-interval fixed-ratio schedules, and Experiment 2 studied conjunctive fixed-interval fixed-ratio schedules. In both, pigeons' output, defined as overall response rate or as responses during the interval, first increased and then decreased as the ratio was raised. With small ratio requirements, the frequency of reinforcement in time either did not change or decreased slightly. With progressively larger ratios, reinforcement frequency decreased consistently. Alternative explanations were discussed. The first, a reinforcement theory account, was that response strength is an increasing monotonic function of both the response requirement and reinforcement frequency, and the bitonic output function represents interacting effects. Increases in the response requirement accompanied by small changes in reinforcement frequency enhance output, but further increases result in large enough decrements in reinforcement frequency so that output is lowered. The second explanation does not view reinforcement as a basic process but, instead, derives from concepts of economics and conservation. Organisms allocate their behavior among alternatives so as to maximize value, where value is a function of the responses that can occur in a given situation under the set of restrictions imposed by particular schedules. One form of this theory explicitly predicts that output is a bitonic function of ratio requirements in simple ratio schedules. However, it was not clear that this model could explain the present effects involving joint ratio and interval schedule restrictions.

  16. Soil quality assessment under emerging regulatory requirements.

    Science.gov (United States)

    Bone, James; Head, Martin; Barraclough, Declan; Archer, Michael; Scheib, Catherine; Flight, Dee; Voulvoulis, Nikolaos

    2010-08-01

    New and emerging policies that aim to set standards for protection and sustainable use of soil are likely to require identification of geographical risk/priority areas. Soil degradation can be seen as the change or disturbance in soil quality and it is therefore crucial that soil and soil quality are well understood to protect soils and to meet legislative requirements. To increase this understanding a review of the soil quality definition evaluated its development, with a formal scientific approach to assessment beginning in the 1970s, followed by a period of discussion and refinement. A number of reservations about soil quality assessment expressed in the literature are summarised. Taking concerns into account, a definition of soil quality incorporating soil's ability to meet multifunctional requirements, to provide ecosystem services, and the potential for soils to affect other environmental media is described. Assessment using this definition requires a large number of soil function dependent indicators that can be expensive, laborious, prone to error, and problematic in comparison. Findings demonstrate the need for a method that is not function dependent, but uses a number of cross-functional indicators instead. This method to systematically prioritise areas where detailed investigation is required, using a ranking based against a desired level of action, could be relatively quick, easy and cost effective. As such this has potential to fill in gaps and compliment existing monitoring programs and assist in development and implementation of current and future soil protection legislation.

  17. 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.

  18. Organic growth factor requirements of some yeasts.

    Science.gov (United States)

    Madan, M; Gulati, N

    1980-01-01

    Some sporogenous yeasts (Brettanomyces bruxellensis, Debaryomyces hansenii, Hansenula ciferrii, Hansenula polymorpha, Pichia polymorpha, Saccharomycopsis guttulata, and Saccharomyces chevalieri), isolated from various fruits have been examined for their organic growth factor requisites. H. ciferrii was completely deficient in thiamine, biotin, inositol, riboflavin, niacin, and partially deficient in pantothenic acid. It required an external supply of 0.1-1.0 ppm thiamine, 0.01-0.1 ppm biotin, 10.0 ppm inositol, 0.10 ppm niacin and riboflavin for its optimum growth. H. polymorpha showed partial deficiency only in xanthine. P. polymorpha gave indications of partial deficiencies in thiamine and biotin. S. guttulata was completely deficient in biotin, and partially deficient in adenine sulphate. It required 0.01 ppm biotin for optimum growth. S chevalieri was completely deficient in pyridoxine and partially deficient in thiamine. It required 0.1 ppm pyridoxine for maximum growth. D. hansenii and B bruxellensis were auxoautotrophic for the various growth factors studied.

  19. Using Abduction to Evolve Inconsistent Requirements Specification

    Directory of Open Access Journals (Sweden)

    Bashar Nuseibeh

    1999-05-01

    Full Text Available Requirements specifications are often inconsistent. Inconsistencies may arise because multiple conflicting requirements are embodied in these specifications, or because the specifications themselves are in a transient stage of evolutionary development. In this paper we argue that such inconsistencies, rather than being undesirable, are actually useful drivers for changing the requirements specifications in which they arise. We present a formal technique to reason about inconsistency handling changes. Our technique is an adaptation of logical abduction - adapted to generate changes that address some specification inconsistencies, while leaving others. We represent our specifications in quasi-classical (QC logic - an adaptation of classical logic that allows continued reasoning in the presence of inconsistency. The paper develops a sound algorithm for automating our abductive reasoning technique and presents illustrative examples drawn from a library system case study.

  20. Advanced Scientific Computing Research Network Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Bacon, Charles; Bell, Greg; Canon, Shane; Dart, Eli; Dattoria, Vince; Goodwin, Dave; Lee, Jason; Hicks, Susan; Holohan, Ed; Klasky, Scott; Lauzon, Carolyn; Rogers, Jim; Shipman, Galen; Skinner, David; Tierney, Brian

    2013-03-08

    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. In support of SC 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 25 years. In October 2012, ESnet and the Office of Advanced Scientific Computing Research (ASCR) of the DOE SC organized a review to characterize the networking requirements of the programs funded by the ASCR program office. The requirements identified at the review are summarized in the Findings section, and are described in more detail in the body of the report.