Sample records for labelled internal standards

  1. Hydrophilic interaction liquid chromatography of anthranilic acid-labelled oligosaccharides with a 4-aminobenzoic acid ethyl ester-labelled dextran hydrolysate internal standard.

    PubMed

    Neville, David C A; Alonzi, Dominic S; Butters, Terry D

    2012-04-13

    Hydrophilic interaction liquid chromatography (HILIC) of fluorescently labelled oligosaccharides is used in many laboratories to analyse complex oligosaccharide mixtures. Separations are routinely performed using a TSK gel-Amide 80 HPLC column, and retention times of different oligosaccharide species are converted to glucose unit (GU) values that are determined with reference to an external standard. However, if retention times were to be compared with an internal standard, consistent and more accurate GU values would be obtained. We present a method to perform internal standard-calibrated HILIC of fluorescently labelled oligosaccharides. The method relies on co-injection of 4-aminobenzoic acid ethyl ester (4-ABEE)-labelled internal standard and detection by UV absorption, with 2-AA (2-aminobenzoic acid)-labelled oligosaccharides. 4-ABEE is a UV chromophore and a fluorophore, but there is no overlap of the fluorescent spectrum of 4-ABEE with the commonly used fluorescent reagents. The dual nature of 4-ABEE allows for accurate calculation of the delay between UV and fluorescent signals when determining the GU values of individual oligosaccharides. The GU values obtained are inherently more accurate as slight differences in gradients that can influence retention are negated by use of an internal standard. Therefore, this paper provides the first method for determination of HPLC-derived GU values of fluorescently labelled oligosaccharides using an internal calibrant. Copyright © 2012 Elsevier B.V. All rights reserved.

  2. Standard addition with internal standardisation as an alternative to using stable isotope labelled internal standards to correct for matrix effects-Comparison and validation using liquid chromatography-​tandem mass spectrometric assay of vitamin D.

    PubMed

    Hewavitharana, Amitha K; Abu Kassim, Nur Sofiah; Shaw, Paul Nicholas

    2018-06-08

    With mass spectrometric detection in liquid chromatography, co-eluting impurities affect the analyte response due to ion suppression/enhancement. Internal standard calibration method, using co-eluting stable isotope labelled analogue of each analyte as the internal standard, is the most appropriate technique available to correct for these matrix effects. However, this technique is not without drawbacks, proved to be expensive because separate internal standard for each analyte is required, and the labelled compounds are expensive or require synthesising. Traditionally, standard addition method has been used to overcome the matrix effects in atomic spectroscopy and was a well-established method. This paper proposes the same for mass spectrometric detection, and demonstrates that the results are comparable to those with the internal standard method using labelled analogues, for vitamin D assay. As conventional standard addition procedure does not address procedural errors, we propose the inclusion of an additional internal standard (not co-eluting). Recoveries determined on human serum samples show that the proposed method of standard addition yields more accurate results than the internal standardisation using stable isotope labelled analogues. The precision of the proposed method of standard addition is superior to the conventional standard addition method. Copyright © 2018 Elsevier B.V. All rights reserved.

  3. International Experience in Standards and Labeling Programs for Rice Cookers

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

    Zhou, Nan; Zheng, Nina

    China has had an active program on energy efficiency standards for household appliances since the mid-1990s. Rice cooker is among the first to be subject to such mandatory regulation, since it is one of the most prevalent electric appliances in Chinese households. Since first introduced in 1989, the minimum energy efficiency standard for rice cookers has not been revised. Therefore, the potential for energy saving is considerable. Initial analysis from CNIS indicates that potential carbon savings is likely to reach 7.6 million tons of CO2 by the 10th year of the standard implementation. Since September 2007, CNIS has been workingmore » with various groups to develop the new standard for rice cookers. With The Energy Foundation's support, LBNL has assisted CNIS in the revision of the minimum energy efficiency standard for rice cookers that is expected to be effective in 2009. Specifically, work has been in the following areas: assistance in developing consumer survey on usage pattern of rice cookers, review of international standards, review of international test procedures, comparison of the international standards and test procedures, and assessment of technical options of reducing energy use. This report particularly summarizes the findings of reviewing international standards and technical options of reducing energy consumption. The report consists of an overview of rice cooker standards and labeling programs and testing procedures in Hong Kong, South Korea, Japan and Thailand, and Japan's case study in developing energy efficiency rice cooker technologies and rice cooker efficiency programs. The results from the analysis can be summarized as the follows: Hong Kong has a Voluntary Energy Efficiency Labeling scheme for electric rice cookers initiated in 2001, with revision implemented in 2007; South Korea has both MEPS and Mandatory Energy Efficiency Label targeting the same category of rice cookers as Hong Kong; Thailand's voluntary endorsement labeling

  4. 18O-labeled proteome reference as global internal standards for targeted quantification by selected reaction monitoring-mass spectrometry.

    PubMed

    Kim, Jong-Seo; Fillmore, Thomas L; Liu, Tao; Robinson, Errol; Hossain, Mahmud; Champion, Boyd L; Moore, Ronald J; Camp, David G; Smith, Richard D; Qian, Wei-Jun

    2011-12-01

    Selected reaction monitoring (SRM)-MS is an emerging technology for high throughput targeted protein quantification and verification in biomarker discovery studies; however, the cost associated with the application of stable isotope-labeled synthetic peptides as internal standards can be prohibitive for screening a large number of candidate proteins as often required in the preverification phase of discovery studies. Herein we present a proof of concept study using an (18)O-labeled proteome reference as global internal standards (GIS) for SRM-based relative quantification. The (18)O-labeled proteome reference (or GIS) can be readily prepared and contains a heavy isotope ((18)O)-labeled internal standard for every possible tryptic peptide. Our results showed that the percentage of heavy isotope ((18)O) incorporation applying an improved protocol was >99.5% for most peptides investigated. The accuracy, reproducibility, and linear dynamic range of quantification were further assessed based on known ratios of standard proteins spiked into the labeled mouse plasma reference. Reliable quantification was observed with high reproducibility (i.e. coefficient of variance <10%) for analyte concentrations that were set at 100-fold higher or lower than those of the GIS based on the light ((16)O)/heavy ((18)O) peak area ratios. The utility of (18)O-labeled GIS was further illustrated by accurate relative quantification of 45 major human plasma proteins. Moreover, quantification of the concentrations of C-reactive protein and prostate-specific antigen was illustrated by coupling the GIS with standard additions of purified protein standards. Collectively, our results demonstrated that the use of (18)O-labeled proteome reference as GIS provides a convenient, low cost, and effective strategy for relative quantification of a large number of candidate proteins in biological or clinical samples using SRM.

  5. International Review of the Development and Implementation of Energy Efficiency Standards and Labeling Programs

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

    Zhou, Nan; Zheng, Nina; Fridley, David

    2012-02-28

    Appliance energy efficiency standards and labeling (S&L) programs have been important policy tools for regulating the efficiency of energy-using products for over 40 years and continue to expand in terms of geographic and product coverage. The most common S&L programs include mandatory minimum energy performance standards (MEPS) that seek to push the market for efficient products, and energy information and endorsement labels that seek to pull the market. This study seeks to review and compare some of the earliest and most well-developed S&L programs in three countries and one region: the U.S. MEPS and ENERGY STAR, Australia MEPS and Energymore » Label, European Union MEPS and Ecodesign requirements and Energy Label and Japanese Top Runner programs. For each program, key elements of S&L programs are evaluated and comparative analyses across the programs undertaken to identify best practice examples of individual elements as well as cross-cutting factors for success and lessons learned in international S&L program development and implementation. The international review and comparative analysis identified several overarching themes and highlighted some common factors behind successful program elements. First, standard-setting and programmatic implementation can benefit significantly from a legal framework that stipulates a specific timeline or schedule for standard-setting and revision, product coverage and legal sanctions for non-compliance. Second, the different MEPS programs revealed similarities in targeting efficiency gains that are technically feasible and economically justified as the principle for choosing a standard level, in many cases at a level that no product on the current market could reach. Third, detailed survey data such as the U.S. Residential Energy Consumption Survey (RECS) and rigorous analyses provide a strong foundation for standard-setting while incorporating the participation of different groups of stakeholders further strengthen the

  6. Status of China's Energy Efficiency Standards and Labels for Appliances and International Collaboration

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

    Zhou, Nan

    2008-03-01

    the development of a monitoring system to track compliance with standards and labeling, CLASP, with support from Japan's Ministry of Economy, Trade and Industry (METI), has expanded its ongoing collaboration with the China National Institute of Standards (CNIS) to include enforcement and monitoring. CNIS has already begun working on the issue of compliance. CNIS has conducted modest sample testing in 2006 for refrigerators, freezers and room air-conditioners, and repeated the same task in 2007 with a similar sample size for three products (refrigerators, freezers, air-conditioners and clothes washers). And, CNIS, with technical support from LBNL, has analyzed the data collected through testing. At the same time, parallel effort has also been paid to look at the potential impact of the label to 2020. In conjunction with CNIS, CLASP technical experts reviewed the standards development timeline of the four products currently subject to the mandatory energy information label. CLASP, with the support of METI/IEEJ, collaborated with CNIS to develop the efficiency grades, providing: technical input to the process; comment and advice on particular technical issues; as well as evaluation of the results. In addition, in order to effectively evaluate the impact of the label on China's market, CLASP further provided assistance to CNIS to collect data on both the efficiency distribution and product volume distribution of refrigerators on the market. This short report summarizes the status of Standards and Labeling program, current enforcement and monitoring mechanism in China, and states the importance of international collaborations.« less

  7. International Review of Standards and Labeling Programs for Distribution Transformers

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

    Letschert, Virginie; Scholand, Michael; Carreño, Ana María

    Transmission and distribution (T&D) losses in electricity networks represent 8.5% of final energy consumption in the world. In Latin America, T&D losses range between 6% and 20% of final energy consumption, and represent 7% in Chile. Because approximately one-third of T&D losses take place in distribution transformers alone, there is significant potential to save energy and reduce costs and carbon emissions through policy intervention to increase distribution transformer efficiency. A large number of economies around the world have recognized the significant impact of addressing distribution losses and have implemented policies to support market transformation towards more efficient distribution transformers. Asmore » a result, there is considerable international experience to be shared and leveraged to inform countries interested in reducing distribution losses through policy intervention. The report builds upon past international studies of standards and labeling (S&L) programs for distribution transformers to present the current energy efficiency programs for distribution transformers around the world.« less

  8. Evaluation of the impact of matrix effect on quantification of pesticides in foods by gas chromatography-mass spectrometry using isotope-labeled internal standards.

    PubMed

    Yarita, Takashi; Aoyagi, Yoshie; Otake, Takamitsu

    2015-05-29

    The impact of the matrix effect in GC-MS quantification of pesticides in food using the corresponding isotope-labeled internal standards was evaluated. A spike-and-recovery study of nine target pesticides was first conducted using paste samples of corn, green soybean, carrot, and pumpkin. The observed analytical values using isotope-labeled internal standards were more accurate for most target pesticides than that obtained using the external calibration method, but were still biased from the spiked concentrations when a matrix-free calibration solution was used for calibration. The respective calibration curves for each target pesticide were also prepared using matrix-free calibration solutions and matrix-matched calibration solutions with blank soybean extract. The intensity ratio of the peaks of most target pesticides to that of the corresponding isotope-labeled internal standards was influenced by the presence of the matrix in the calibration solution; therefore, the observed slope varied. The ratio was also influenced by the type of injection method (splitless or on-column). These results indicated that matrix-matching of the calibration solution is required for very accurate quantification, even if isotope-labeled internal standards were used for calibration. Copyright © 2015 Elsevier B.V. All rights reserved.

  9. Reliable LC-MS quantitative glycomics using iGlycoMab stable isotope labeled glycans as internal standards.

    PubMed

    Zhou, Shiyue; Tello, Nadia; Harvey, Alex; Boyes, Barry; Orlando, Ron; Mechref, Yehia

    2016-06-01

    Glycans have numerous functions in various biological processes and participate in the progress of diseases. Reliable quantitative glycomic profiling techniques could contribute to the understanding of the biological functions of glycans, and lead to the discovery of potential glycan biomarkers for diseases. Although LC-MS is a powerful analytical tool for quantitative glycomics, the variation of ionization efficiency and MS intensity bias are influencing quantitation reliability. Internal standards can be utilized for glycomic quantitation by MS-based methods to reduce variability. In this study, we used stable isotope labeled IgG2b monoclonal antibody, iGlycoMab, as an internal standard to reduce potential for errors and to reduce variabililty due to sample digestion, derivatization, and fluctuation of nanoESI efficiency in the LC-MS analysis of permethylated N-glycans released from model glycoproteins, human blood serum, and breast cancer cell line. We observed an unanticipated degradation of isotope labeled glycans, tracked a source of such degradation, and optimized a sample preparation protocol to minimize degradation of the internal standard glycans. All results indicated the effectiveness of using iGlycoMab to minimize errors originating from sample handling and instruments. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  10. Standard terminology and labeling of ocular tissue for transplantation.

    PubMed

    Armitage, W John; Ashford, Paul; Crow, Barbara; Dahl, Patricia; DeMatteo, Jennifer; Distler, Pat; Gopinathan, Usha; Madden, Peter W; Mannis, Mark J; Moffatt, S Louise; Ponzin, Diego; Tan, Donald

    2013-06-01

    To develop an internationally agreed terminology for describing ocular tissue grafts to improve the accuracy and reliability of information transfer, to enhance tissue traceability, and to facilitate the gathering of comparative global activity data, including denominator data for use in biovigilance analyses. ICCBBA, the international standards organization for terminology, coding, and labeling of blood, cells, and tissues, approached the major Eye Bank Associations to form an expert advisory group. The group met by regular conference calls to develop a standard terminology, which was released for public consultation and amended accordingly. The terminology uses broad definitions (Classes) with modifying characteristics (Attributes) to define each ocular tissue product. The terminology may be used within the ISBT 128 system to label tissue products with standardized bar codes enabling the electronic capture of critical data in the collection, processing, and distribution of tissues. Guidance on coding and labeling has also been developed. The development of a standard terminology for ocular tissue marks an important step for improving traceability and reducing the risk of mistakes due to transcription errors. ISBT 128 computer codes have been assigned and may now be used to label ocular tissues. Eye banks are encouraged to adopt this standard terminology and move toward full implementation of ISBT 128 nomenclature, coding, and labeling.

  11. Comparison of Test Procedures and Energy Efficiency Criteria in Selected International Standards and Labeling Programs for Clothes Washers, Water Dispensers, Vending Machines and CFLs

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

    Fridley, David; Zheng, Nina; Zhou, Nan

    Since the late 1970s, energy labeling programs and mandatory energy performance standards have been used in many different countries to improve the efficiency levels of major residential and commercial equipment. As more countries and regions launch programs covering a greater range of products that are traded worldwide, greater attention has been given to harmonizing the specific efficiency criteria in these programs and the test methods for measurements. For example, an international compact fluorescent light (CFL) harmonization initiative was launched in 2006 to focus on collaboration between Australia, China, Europe and North America. Given the long history of standards and labelingmore » programs, most major energy-consuming residential appliances and commercial equipment are already covered under minimum energy performance standards (MEPS) and/or energy labels. For these products, such as clothes washers and CFLs, harmonization may still be possible when national MEPS or labeling thresholds are revised. Greater opportunity for harmonization exists in newer energy-consuming products that are not commonly regulated but are under consideration for new standards and labeling programs. This may include commercial products such as water dispensers and vending machines, which are only covered by MEPS or energy labels in a few countries or regions. As China continues to expand its appliance standards and labeling programs and revise existing standards and labels, it is important to learn from recent international experiences with efficiency criteria and test procedures for the same products. Specifically, various types of standards and labeling programs already exist in North America, Europe and throughout Asia for products in China's 2010 standards and labeling programs, namely clothes washers, water dispensers, vending machines and CFLs. This report thus examines similarities and critical differences in energy efficiency values, test procedure specifications and

  12. Production of isotopically labeled standards from a uniformly labeled precursor for quantitative volatile metabolomic studies.

    PubMed

    Gómez-Cortés, Pilar; Brenna, J Thomas; Sacks, Gavin L

    2012-06-19

    Optimal accuracy and precision in small-molecule profiling by mass spectrometry generally requires isotopically labeled standards chemically representative of all compounds of interest. However, preparation of mixed standards from commercially available pure compounds is often prohibitively expensive and time-consuming, and many labeled compounds are not available in pure form. We used a single-prototype uniformly labeled [U-(13)C]compound to generate [U-(13)C]-labeled volatile standards for use in subsequent experimental profiling studies. [U-(13)C]-α-Linolenic acid (18:3n-3, ALA) was thermally oxidized to produce labeled lipid degradation volatiles which were subsequently characterized qualitatively and quantitatively. Twenty-five [U-(13)C]-labeled volatiles were identified by headspace solid-phase microextraction-gas chromatography/time-of-flight mass spectrometry (HS-SPME-GC/TOF-MS) by comparison of spectra with unlabeled volatiles. Labeled volatiles were quantified by a reverse isotope dilution procedure. Using the [U-(13)C]-labeled standards, limits of detection comparable to or better than those of previous HS-SPME reports were achieved, 0.010-1.04 ng/g. The performance of the [U-(13)C]-labeled volatile standards was evaluated using a commodity soybean oil (CSO) oxidized at 60 °C from 0 to 15 d. Relative responses of n-decane, an unlabeled internal standard otherwise absent from the mixture, and [U-(13)C]-labeled oxidation products changed by up to 8-fold as the CSO matrix was oxidized, demonstrating that reliance on a single standard in volatile profiling studies yields inaccurate results due to changing matrix effects. The [U-(13)C]-labeled standard mixture was used to quantify 25 volatiles in oxidized CSO and low-ALA soybean oil with an average relative standard deviation of 8.5%. Extension of this approach to other labeled substrates, e.g., [U-(13)C]-labeled sugars and amino acids, for profiling studies should be feasible and can dramatically improve

  13. Comparison of Test Procedures and Energy Efficiency Criteria in Selected International Standards & Labeling Programs for Copy Machines, External Power Supplies, LED Displays, Residential Gas Cooktops and Televisions

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

    Zheng, Nina; Zhou, Nan; Fridley, David

    2012-03-01

    This report presents a technical review of international minimum energy performance standards (MEPS), voluntary and mandatory energy efficiency labels and test procedures for five products being considered for new or revised MEPS in China: copy machines, external power supply, LED displays, residential gas cooktops and flat-screen televisions. For each product, an overview of the scope of existing international standards and labeling programs, energy values and energy performance metrics and description and detailed summary table of criteria and procedures in major test standards are presented.

  14. Comparison of international food allergen labeling regulations.

    PubMed

    Gendel, Steven M

    2012-07-01

    Food allergy is a significant public health issue worldwide. Regulatory risk management strategies for allergic consumers have focused on providing information about the presence of food allergens through label declarations. A number of countries and regulatory bodies have recognized the importance of providing this information by enacting laws, regulations or standards for food allergen labeling of "priority allergens". However, different governments and organizations have taken different approaches to identifying these "priority allergens" and to designing labeling declaration regulatory frameworks. The increasing volume of the international food trade suggests that there would be value in supporting sensitive consumers by harmonizing (to the extent possible) these regulatory frameworks. As a first step toward this goal, an inventory of allergen labeling regulations was assembled and analyzed to identify commonalities, differences, and future needs. Published by Elsevier Inc.

  15. Compensation of matrix effects in gas chromatography-mass spectrometry analysis of pesticides using a combination of matrix matching and multiple isotopically labeled internal standards.

    PubMed

    Tsuchiyama, Tomoyuki; Katsuhara, Miki; Nakajima, Masahiro

    2017-11-17

    In the multi-residue analysis of pesticides using GC-MS, the quantitative results are adversely affected by a phenomenon known as the matrix effect. Although the use of matrix-matched standards is considered to be one of the most practical solutions to this problem, complete removal of the matrix effect is difficult in complex food matrices owing to their inconsistency. As a result, residual matrix effects can introduce analytical errors. To compensate for residual matrix effects, we have developed a novel method that employs multiple isotopically labeled internal standards (ILIS). The matrix effects of ILIS and pesticides were evaluated in spiked matrix extracts of various agricultural commodities, and the obtained data were subjected to simple statistical analysis. Based on the similarities between the patterns of variation in the analytical response, a total of 32 isotopically labeled compounds were assigned to 338 pesticides as internal standards. It was found that by utilizing multiple ILIS, residual matrix effects could be effectively compensated. The developed method exhibited superior quantitative performance compared with the common single-internal-standard method. The proposed method is more feasible for regulatory purposes than that using only predetermined correction factors and is considered to be promising for practical applications. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Energy-efficiency labels and standards: A guidebook for appliances, equipment and lighting

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

    McMahon, James E.; Wiel, Stephen

    2001-02-16

    Energy-performance improvements in consumer products are an essential element in any government's portfolio of energy-efficiency and climate change mitigation programs. Governments need to develop balanced programs, both voluntary and regulatory, that remove cost-ineffective, energy-wasting products from the marketplace and stimulate the development of cost-effective, energy-efficient technology. Energy-efficiency labels and standards for appliances, equipment, and lighting products deserve to be among the first policy tools considered by a country's energy policy makers. The U.S. Agency for International Development (USAID) and the United Nations Foundation (UNF) recognize the need to support policy makers in their efforts to implement energy-efficiency standards and labelingmore » programs and have developed this guidebook, together with the Collaborative Labeling and Appliance Standards Program (CLASP), as a primary reference. This guidebook was prepared over the course of the past year with significant contribution from the authors and reviewers mentioned previously. Their diligent participation has made this the international guidance tool it was intended to be. The lead authors would also like to thank the following individuals for their support in the development, production, and distribution of the guidebook: Marcy Beck, Elisa Derby, Diana Dhunke, Ted Gartner, and Julie Osborn of Lawrence Berkeley National Laboratory as well as Anthony Ma of Bevilacqua-Knight, Inc. This guidebook is designed as a manual for government officials and others around the world responsible for developing, implementing, enforcing, monitoring, and maintaining labeling and standards-setting programs. It discusses the pros and cons of adopting energy-efficiency labels and standards and describes the data, facilities, and institutional and human resources needed for these programs. It provides guidance on the design, development, implementation, maintenance, and evaluation of the

  17. Energy-Efficiency Labels and Standards: A Guidebook forAppliances, Equipment, and Lighting - 2nd Edition

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

    Wiel, Stephen; McMahon, James E.

    2005-04-28

    Energy-performance improvements in consumer products are an essential element in any government's portfolio of energy-efficiency and climate change mitigation programs. Governments need to develop balanced programs, both voluntary and regulatory, that remove cost-ineffective, energy-wasting products from the marketplace and stimulate the development of cost-effective, energy-efficient technology. Energy-efficiency labels and standards for appliances, equipment, and lighting products deserve to be among the first policy tools considered by a country's energy policy makers. The U.S. Agency for International Development (USAID) and several other organizations identified on the cover of this guidebook recognize the need to support policy makers in their efforts tomore » implement energy-efficiency standards and labeling programs and have developed this guidebook, together with the Collaborative Labeling and Appliance Standards Program (CLASP), as a primary reference. This second edition of the guidebook was prepared over the course of the past year, four years after the preparation of the first edition, with a significant contribution from the authors and reviewers mentioned previously. Their diligent participation helps maintain this book as the international guidance tool it has become. The lead authors would like to thank the members of the Communications Office of the Environmental Energy Technologies Division, Lawrence Berkeley National Laboratory for their support in the development, production, and distribution of the guidebook. This guidebook is designed as a manual for government officials and others around the world responsible for developing, implementing, enforcing, monitoring, and maintaining labeling and standards setting programs. It discusses the pros and cons of adopting energy-efficiency labels and standards and describes the data, facilities, and institutional and human resources needed for these programs. It provides guidance on the design

  18. Simultaneous determination of chlorantraniliprole and cyantraniliprole in fruits, vegetables and cereals using ultra-high-performance liquid chromatography-tandem mass spectrometry with the isotope-labelled internal standard method.

    PubMed

    Pan, Xinglu; Dong, Fengshou; Xu, Jun; Liu, Xingang; Chen, Zenglong; Liu, Na; Chen, Xixi; Tao, Yan; Zhang, Hongjun; Zheng, Yongquan

    2015-05-01

    A reliable and sensitive isotope-labelled internal standard method for simultaneous determination of chlorantraniliprole and cyantraniliprole in fruits (apple and grape), vegetables (cucumber and tomato) and cereals (rice and wheat) using ultra-high-performance liquid chromatography-tandem mass spectrometry was developed. Isotope-labelled internal standards were effective in compensating for the loss in the pretreatment and overcoming the matrix effect. The analytes were extracted with acetonitrile and cleaned up with different kinds of sorbents. The determination of the target compounds was achieved in less than 4 min using a T3 column combined with an electrospray ionization source in positive mode. The overall average relative recoveries in all matrices at three spiking levels (10, 20 and 50 μg kg(-1)) ranged from 95.5 to 106.2 %, with all relative standard deviations being less than 14.4 % for all analytes. The limits of detection did not exceed 0.085 μg kg(-1) and the limits of quantification were below 0.28 μg kg(-1) in all matrices. The method was demonstrated to be convenient and accurate for the routine monitoring of chlorantraniliprole and cyantraniliprole in fruits, vegetables and cereals.

  19. Food and nutrition labelling in Thailand: a long march from subsistence producers to international traders

    PubMed Central

    Rimpeekool, Wimalin; Seubsman, Sam-ang; Banwell, Cathy; Kirk, Martyn; Yiengprugsawan, Vasoontara; Sleigh, Adrian

    2015-01-01

    This paper reviews the evolution of Thai food and nutrition label policies and Thailand’s international role relating to food product safety and standards. The historical record has been interpreted to identify future trends and challenges related to food labelling. These challenges are arising in Thailand and many similar emerging economies. Thailand has a good reputation in world food markets and is now becoming a global leader in food production and export. It has become deeply involved with regulations and standards applied by World Trade Organization and Codex Alimentarius while serving its own population with a safe and secure food supply. For consumers considering Thai food products, food labels can provide useful nutrition information and help build trust. Thais began a century ago with policies and laws to enhance food safety and to protect Thai consumers. During the lengthy journey from national to global standards Thai food labels have evolved and now contribute to international food labelling policies. This contribution comes from the perspective of a leading middle income south-east Asian food producer now trading with high income countries around the world. The story of that journey – a case study for many other countries in a similar situation – has not previously been told. This article provides information for policy makers dealing with food labelling, embedding trends and tensions for one middle income food exporter in a long history. Information captured here should be helpful for other middle income countries, especially those with limited records. This strategic knowledge will enable better decisions for future policies. PMID:26538793

  20. Correction for isotopic interferences between analyte and internal standard in quantitative mass spectrometry by a nonlinear calibration function.

    PubMed

    Rule, Geoffrey S; Clark, Zlatuse D; Yue, Bingfang; Rockwood, Alan L

    2013-04-16

    Stable isotope-labeled internal standards are of great utility in providing accurate quantitation in mass spectrometry (MS). An implicit assumption has been that there is no "cross talk" between signals of the internal standard and the target analyte. In some cases, however, naturally occurring isotopes of the analyte do contribute to the signal of the internal standard. This phenomenon becomes more pronounced for isotopically rich compounds, such as those containing sulfur, chlorine, or bromine, higher molecular weight compounds, and those at high analyte/internal standard concentration ratio. This can create nonlinear calibration behavior that may bias quantitative results. Here, we propose the use of a nonlinear but more accurate fitting of data for these situations that incorporates one or two constants determined experimentally for each analyte/internal standard combination and an adjustable calibration parameter. This fitting provides more accurate quantitation in MS-based assays where contributions from analyte to stable labeled internal standard signal exist. It can also correct for the reverse situation where an analyte is present in the internal standard as an impurity. The practical utility of this approach is described, and by using experimental data, the approach is compared to alternative fits.

  1. Educational Labeling System for Atmospheres (ELSA): Python Tool Development for Archiving Under the PDS4 Standard

    NASA Astrophysics Data System (ADS)

    Neakrase, Lynn; Hornung, Danae; Sweebe, Kathrine; Huber, Lyle; Chanover, Nancy J.; Stevenson, Zena; Berdis, Jodi; Johnson, Joni J.; Beebe, Reta F.

    2017-10-01

    The Research and Analysis programs within NASA’s Planetary Science Division now require archiving of resultant data with the Planetary Data System (PDS) or an equivalent archive. The PDS Atmospheres Node is developing an online environment for assisting data providers with this task. The Educational Labeling System for Atmospheres (ELSA) is being designed with Django/Python coding to provide an easier environment for facilitating not only communication with the PDS node, but also streamlining the process of learning, developing, submitting, and reviewing archive bundles under the new PDS4 archiving standard. Under the PDS4 standard, data are archived in bundles, collections, and basic products that form an organizational hierarchy of interconnected labels that describe the data and relationships between the data and its documentation. PDS4 labels are implemented using Extensible Markup Language (XML), which is an international standard for managing metadata. Potential data providers entering the ELSA environment can learn more about PDS4, plan and develop label templates, and build their archive bundles. ELSA provides an interface to tailor label templates aiding in the creation of required internal Logical Identifiers (URN - Uniform Resource Names) and Context References (missions, instruments, targets, facilities, etc.). The underlying structure of ELSA uses Django/Python code that make maintaining and updating the interface easy to do for our undergraduate/graduate students. The ELSA environment will soon provide an interface for using the tailored templates in a pipeline to produce entire collections of labeled products, essentially building the user’s archive bundle. Once the pieces of the archive bundle are assembled, ELSA provides options for queuing the completed bundle for peer review. The peer review process has also been streamlined for online access and tracking to help make the archiving process with PDS as transparent as possible. We discuss the

  2. Fluorescein thiocarbamyl amino acids as internal standards for migration time correction in capillary sieving electrophoresis

    PubMed Central

    Pugsley, Haley R.; Swearingen, Kristian E.; Dovichi, Norman J.

    2009-01-01

    A number of algorithms have been developed to correct for migration time drift in capillary electrophoresis. Those algorithms require identification of common components in each run. However, not all components may be present or resolved in separations of complex samples, which can confound attempts for alignment. This paper reports the use of fluorescein thiocarbamyl derivatives of amino acids as internal standards for alignment of 3-(2-furoyl)quinoline-2-carboxaldehyde (FQ)-labeled proteins in capillary sieving electrophoresis. The fluorescein thiocarbamyl derivative of aspartic acid migrates before FQ-labeled proteins and the fluorescein thiocarbamyl derivative of arginine migrates after the FQ-labeled proteins. These compounds were used as internal standards to correct for variations in migration time over a two-week period in the separation of a cellular homogenate. The experimental conditions were deliberately manipulated by varying electric field and sample preparation conditions. Three components of the homogenate were used to evaluate the alignment efficiency. Before alignment, the average relative standard deviation in migration time for these components was 13.3%. After alignment, the average relative standard deviation in migration time for these components was reduced to 0.5%. PMID:19249052

  3. 50 CFR 216.91 - Dolphin-safe labeling standards.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... MAMMALS Dolphin Safe Tuna Labeling § 216.91 Dolphin-safe labeling standards. (a) It is a violation of..., distributor, or seller of any tuna products that are exported from or offered for sale in the United States to... suggests that the tuna contained in the products were harvested using a method of fishing that is not...

  4. 50 CFR 216.91 - Dolphin-safe labeling standards.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... MAMMALS Dolphin Safe Tuna Labeling § 216.91 Dolphin-safe labeling standards. (a) It is a violation of..., distributor, or seller of any tuna products that are exported from or offered for sale in the United States to... suggests that the tuna contained in the products were harvested using a method of fishing that is not...

  5. 50 CFR 216.91 - Dolphin-safe labeling standards.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... MAMMALS Dolphin Safe Tuna Labeling § 216.91 Dolphin-safe labeling standards. (a) It is a violation of..., distributor, or seller of any tuna products that are exported from or offered for sale in the United States to... suggests that the tuna contained in the products were harvested using a method of fishing that is not...

  6. 50 CFR 216.91 - Dolphin-safe labeling standards.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... MAMMALS Dolphin Safe Tuna Labeling § 216.91 Dolphin-safe labeling standards. (a) It is a violation of..., distributor, or seller of any tuna products that are exported from or offered for sale in the United States to... suggests that the tuna contained in the products were harvested using a method of fishing that is not...

  7. 50 CFR 216.91 - Dolphin-safe labeling standards.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... MAMMALS Dolphin Safe Tuna Labeling § 216.91 Dolphin-safe labeling standards. (a) It is a violation of..., distributor, or seller of any tuna products that are exported from or offered for sale in the United States to... suggests that the tuna contained in the products were harvested using a method of fishing that is not...

  8. Development and implementation of energy efficiency standards and labeling programs in China: Progress and challenges

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

    Zhou, Nan; Khanna, Nina Zheng; Fridley, David

    Over the last twenty years, with growing policy emphasis on improving energy efficiency and reducing environmental pollution and carbon emissions, China has implemented a series of new minimum energy performance standards (MEPS) and mandatory and voluntary energy labels to improve appliance energy efficiency. As China begins planning for the next phase of standards and labeling (S&L) program development under the 12th Five Year Plan, an evaluation of recent program developments and future directions is needed to identify gaps that still exist when compared with international best practices. The review of China’s S&L program development and implementation in comparison with majormore » findings from international experiences reveal that there are still areas of improvement, particularly when compared to success factors observed across leading international S&L program. China currently lacks a formalized regulatory process for standard-setting and do not have any legal or regulatory guidance on elements of S&L development such as stakeholder participation or the issue of legal precedence between conflicting national, industrial and local standards. Consequently, China’s laws regarding standard-setting and management of the mandatory energy label program could be updated, as they have not been amended or revised recently and no longer reflects the current situation. While China uses similar principles for choosing target products as the U.S., Australia, EU and Japan, including high energy-consumption, mature industry and testing procedure and stakeholder support, recent MEPS revisions have generally aimed at only eliminating the bottom 20% efficiency of the market. Setting a firm principle based on maximizing energy savings that are technically feasible and economically justified may help improve the stringency of China’s MEPS program and reduce the need for frequent revisions. China also lacks robust survey data and relies primarily on market research data in

  9. Ionization enhancement in atmospheric pressure chemical ionization and suppression in electrospray ionization between target drugs and stable-isotope-labeled internal standards in quantitative liquid chromatography/tandem mass spectrometry.

    PubMed

    Liang, H R; Foltz, R L; Meng, M; Bennett, P

    2003-01-01

    The phenomena of ionization suppression in electrospray ionization (ESI) and enhancement in atmospheric pressure chemical ionization (APCI) were investigated in selected-ion monitoring and selected-reaction monitoring modes for nine drugs and their corresponding stable-isotope-labeled internal standards (IS). The results showed that all investigated target drugs and their co-eluting isotope-labeled IS suppress each other's ionization responses in ESI. The factors affecting the extent of suppression in ESI were investigated, including structures and concentrations of drugs, matrix effects, and flow rate. In contrast to the ESI results, APCI caused seven of the nine investigated target drugs and their co-eluting isotope-labeled IS to enhance each other's ionization responses. The mutual ionization suppression or enhancement between drugs and their isotope-labeled IS could possibly influence assay sensitivity, reproducibility, accuracy and linearity in quantitative liquid chromatography/mass spectrometry (LC/MS) and liquid chromatography/tandem mass spectrometry (LC/MS/MS). However, calibration curves were linear if an appropriate IS concentration was selected for a desired calibration range to keep the response factors constant. Copyright 2003 John Wiley & Sons, Ltd.

  10. 21 CFR 130.11 - Label designations of ingredients for standardized foods.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Label designations of ingredients for standardized foods. 130.11 Section 130.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD STANDARDS: GENERAL General Provisions § 130.11 Label...

  11. 21 CFR 130.11 - Label designations of ingredients for standardized foods.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Label designations of ingredients for standardized foods. 130.11 Section 130.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD STANDARDS: GENERAL General Provisions § 130.11 Label...

  12. The effect of 'standard drink' labelling on the ability of drinkers to pour a 'standard drink'.

    PubMed

    Stockwell, T; Blaze-Temple, D; Walker, C

    1991-03-01

    Australia's National Health Policy on Alcohol has recommended that beverage containers be labelled so that alcohol content is 'readily understandable by the public'. Health promotion to increase the responsible use of alcohol now relies extensively on the concept of a standard drink--usually defined as 10 g of ethyl alcohol. Numerous difficulties confront a drinker who wishes to apply the standard drink system to monitor alcohol intake. This report describes a series of experimental tests of the proposal that these difficulties are minimised if alcohol containers have their alcohol content indicated in terms of standard drinks in addition to the usual percentage alcohol by volume method. Subjects were drinkers recruited from a Perth shopping mall and were tested only on beverage types they had consumed within the previous week. They were required to pour what they judged to be a single standard drink from a 750 ml bottle of either wine or beer. Beer drinkers achieved greater accuracy in this task when the bottles had standard drink labels, even when the glass size and beverage strength were varied. Wine drinkers had equal difficulty with this task whether standard drink or percentage labels were used. The addition of a 'ladder' up the side of a wine bottle with graduations in standard drinks would be necessary for wine drinkers to achieve a high level of accuracy. We conclude that labelling drink containers with their alcohol content in terms of standard drinks would better equip all drinkers to follow the advice of health educators.

  13. Creating and Implementing a Regularized Monitoring and EnforcementSystem for China's Mandatory Standards and Energy Information Label forAppliances

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

    Lin, Jiang

    2007-03-01

    Institute of Standardization (CNIS), the China Administration for Quality, Supervision, Inspection and Quarantine (AQSIQ) and relevant stakeholders in the industry to develop a stronger system of monitoring and enforcement. In November 2005, CNIS and LBNL (a CLASP implementing partner) with funding from the Energy Foundation jointly organized an international workshop to present the international best practices in S&L monitoring and enforcement. Currently, CNIS is developing a guideline for monitoring and enforcement for appliance standards. With support from METI, CLASP has been able to expand the on-going collaboration with CNIS to include enforcement needs for the mandatory energy information label and to accelerate the progress of the project to develop a more robust monitoring and enforcement for S&L programs in China. This expanded effort has included: (1) Holding an enforcement and monitoring roadmap planning workshop with key S&L stakeholders; (2) Interviews with S&L stakeholders on the need and scope of national compliance tests; (3) Research on past enforcement activities; (4) An analysis of compliance data from the mandatory energy information labeling program; (5) Interviews with stakeholders on the need and scope of testing infrastructure; and (6) Development of a roadmap for future activities. This report summarizes the findings of these activities and identifies the progress that China is making, and can make, toward developing a stronger system of monitoring and enforcement (M&E). In sum, it outlines a vision of moving forward with more vigorous M&E in China.« less

  14. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...

  15. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...

  16. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...

  17. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...

  18. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...

  19. Reference standard space hippocampus labels according to the European Alzheimer's Disease Consortium-Alzheimer's Disease Neuroimaging Initiative harmonized protocol: Utility in automated volumetry.

    PubMed

    Wolf, Dominik; Bocchetta, Martina; Preboske, Gregory M; Boccardi, Marina; Grothe, Michel J

    2017-08-01

    A harmonized protocol (HarP) for manual hippocampal segmentation on magnetic resonance imaging (MRI) has recently been developed by an international European Alzheimer's Disease Consortium-Alzheimer's Disease Neuroimaging Initiative project. We aimed at providing consensual certified HarP hippocampal labels in Montreal Neurological Institute (MNI) standard space to serve as reference in automated image analyses. Manual HarP tracings on the high-resolution MNI152 standard space template of four expert certified HarP tracers were combined to obtain consensual bilateral hippocampus labels. Utility and validity of these reference labels is demonstrated in a simple atlas-based morphometry approach for automated calculation of HarP-compliant hippocampal volumes within SPM software. Individual tracings showed very high agreement among the four expert tracers (pairwise Jaccard indices 0.82-0.87). Automatically calculated hippocampal volumes were highly correlated (r L/R  = 0.89/0.91) with gold standard volumes in the HarP benchmark data set (N = 135 MRIs), with a mean volume difference of 9% (standard deviation 7%). The consensual HarP hippocampus labels in the MNI152 template can serve as a reference standard for automated image analyses involving MNI standard space normalization. Copyright © 2017 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  20. Global Potential of Energy Efficiency Standards and Labeling Programs

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

    McNeil, Michael A; McNeil, Michael A.; Letschert, Virginie

    2008-06-15

    This report estimates the global potential reductions in greenhouse gas emissions by 2030 for energy efficiency improvements associated with equipment (appliances, lighting, and HVAC) in buildings by means of energy efficiency standards and labels (EES&L). A consensus has emerged among the world's scientists and many corporate and political leaders regarding the need to address the threat of climate change through emissions mitigation and adaptation. A further consensus has emerged that a central component of these strategies must be focused around energy, which is the primary generator of greenhouse gas emissions. Two important questions result from this consensus: 'what kinds ofmore » policies encourage the appropriate transformation to energy efficiency' and 'how much impact can these policies have'? This report aims to contribute to the dialogue surrounding these issues by considering the potential impacts of a single policy type, applied on a global scale. The policy addressed in this report is Energy Efficient Standards and Labeling (EES&L) for energy-consuming equipment, which has now been implemented in over 60 countries. Mandatory energy performance standards are important because they contribute positively to a nation's economy and provide relative certainty about the outcome (both timing and magnitudes). Labels also contribute positively to a nation's economy and importantly increase the awareness of the energy-consuming public. Other policies not analyzed here (utility incentives, tax credits) are complimentary to standards and labels and also contribute in significant ways to reducing greenhouse gas emissions. We believe the analysis reported here to be the first systematic attempt to evaluate the potential of savings from EES&L for all countries and for such a large set of products. The goal of the analysis is to provide an assessment that is sufficiently well-quantified and accurate to allow comparison and integration with other strategies under

  1. Live Imaging of Cellular Internalization of Single Colloidal Particle by Combined Label-Free and Fluorescence Total Internal Reflection Microscopy.

    PubMed

    Byrne, Gerard D; Vllasaliu, Driton; Falcone, Franco H; Somekh, Michael G; Stolnik, Snjezana

    2015-11-02

    In this work we utilize the combination of label-free total internal reflection microscopy and total internal reflectance fluorescence (TIRM/TIRF) microscopy to achieve a simultaneous, live imaging of single, label-free colloidal particle endocytosis by individual cells. The TIRM arm of the microscope enables label free imaging of the colloid and cell membrane features, while the TIRF arm images the dynamics of fluorescent-labeled clathrin (protein involved in endocytosis via clathrin pathway), expressed in transfected 3T3 fibroblasts cells. Using a model polymeric colloid and cells with a fluorescently tagged clathrin endocytosis pathway, we demonstrate that wide field TIRM/TIRF coimaging enables live visualization of the process of colloidal particle interaction with the labeled cell structure, which is valuable for discerning the membrane events and route of colloid internalization by the cell. We further show that 500 nm in diameter model polystyrene colloid associates with clathrin, prior to and during its cellular internalization. This association is not apparent with larger, 1 μm in diameter colloids, indicating an upper particle size limit for clathrin-mediated endocytosis.

  2. Current situation of International Organization for Standardization/Technical Committee 249 international standards of traditional Chinese medicine.

    PubMed

    Liu, Yu-Qi; Wang, Yue-Xi; Shi, Nan-Nan; Han, Xue-Jie; Lu, Ai-Ping

    2017-05-01

    To review the current situation and progress of traditional Chinese medicine (TCM) international standards, standard projects and proposals in International Organization for Standardization (ISO)/ technical committee (TC) 249. ISO/TC 249 standards and standard projects on the ISO website were searched and new standard proposals information were collected from ISO/TC 249 National Mirror Committee in China. Then all the available data were summarized in 5 closely related items, including proposed time, proposed country, assigned working group (WG), current stage and classifification. In ISO/TC 249, there were 2 international standards, 18 standard projects and 24 new standard proposals proposed in 2014. These 44 standard subjects increased year by year since 2011. Twenty-nine of them were proposed by China, 15 were assigned to WG 4, 36 were in preliminary and preparatory stage and 8 were categorized into 4 fifields, 7 groups and sub-groups based on International Classifification Standards. A rapid and steady development of international standardization in TCM can be observed in ISO/TC 249.

  3. International Standardization of Bed Rest Standard Measures

    NASA Technical Reports Server (NTRS)

    Cromwell, Ronita L.

    2010-01-01

    This slide presentation gives an overview of the standardization of bed rest measures. The International Countermeasures Working Group attempted to define and agree internationally on standard measurements for spaceflight based bed rest studies. The group identified the experts amongst several stakeholder agencys. It included information on exercise, muscle, neurological, psychological, bone and cardiovascular measures.

  4. The internalization of fluorescence-labeled PLA nanoparticles by macrophages.

    PubMed

    Li, Fengjuan; Zhu, Aiping; Song, Xiaoli; Ji, Lijun; Wang, Juan

    2013-09-10

    Rhodamine B (RhB)-labeled PLA nanoparticles were prepared through surface grafting copolymerization of glycidyl methacrylate (GMA) onto PLA nanoparticles during the emulsion/evaporation process. RhB firstly interacts with sodium dodecyl sulfate (SDS) through electrostatic interaction to form hydrophobic complex (SDS-RhB). Due to the high-affinity of SDS-RhB with GMA, hydrophilic RhB can be successfully combined into PLA nanoparticles. The internalization of RhB-labeled PLA nanoparticles by macrophages was investigated with fluorescence microscope technology. The effects of the PLA nanoparticle surface nature and size on the internalization were investigated. The results indicate that the PLA particles smaller than 200 nm can avoid the uptake of phagocytosis. The bigger PLA particles (300 nm) with polyethylene glycol (PEG) surface showed less internalization by macrophage compared with those with poly(ethylene oxide-propylene oxide) copolymer (F127) or poly(vinyl alcohol) (PVA) surface. The "stealth" function of PEG on the PLA nanoparticles from internalization of macrophages due to the low protein adsorption is revealed by electrochemical impedance technology. Copyright © 2013 Elsevier B.V. All rights reserved.

  5. Label free imaging of cell-substrate contacts by holographic total internal reflection microscopy.

    PubMed

    Mandracchia, Biagio; Gennari, Oriella; Marchesano, Valentina; Paturzo, Melania; Ferraro, Pietro

    2017-09-01

    The study of cell adhesion contacts is pivotal to understand cell mechanics and interaction at substrates or chemical and physical stimuli. We designed and built a HoloTIR microscope for label-free quantitative phase imaging of total internal reflection. Here we show for the first time that HoloTIR is a good choice for label-free study of focal contacts and of cell/substrate interaction as its sensitivity is enhanced in comparison with standard TIR microscopy. Finally, the simplicity of implementation and relative low cost, due to the requirement of less optical components, make HoloTIR a reasonable alternative, or even an addition, to TIRF microscopy for mapping cell/substratum topography. As a proof of concept, we studied the formation of focal contacts of fibroblasts on three substrates with different levels of affinity for cell adhesion. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

  6. The International Standard for Aureomycin

    PubMed Central

    Humphrey, J. H.; Lightbown, J. W.; Mussett, M. V.; Perry, W. L. M.

    1953-01-01

    In 1950, the Department of Biological Standards, National Institute for Medical Research, London, was authorized by the WHO Expert Committee on Biological Standardization to proceed with the establishment of an International Standard for Aureomycin. A 100-g batch of aureomycin was obtained and was compared with the Standard Preparation of Aureomycin of the United States Food and Drug Administration (FDA) in a collaborative assay in which six laboratories in five countries participated. In all, 30 assays were carried out; 26 of these were done by biological methods, using Sarcina lutea, Bacillus pumilus, Staphylococcus aureus, or Bacillus cereus, and the remaining four by physicochemical methods. The results were subjected to standard methods of analysis, and the overall weighted mean potency (calculated from the biological assays only) was 1.0139, with limits of error of 99.5% to 100.5%. Since the International Standard is 1.39% more potent than the FDA Standard Preparation, it is probable that the latter contains a small amount of inert material; it is also possible that the International Standard itself is not 100% pure. For most practical purposes, however, both preparations may be regarded as substantially pure, and it is considered that to alter the present practice of quoting aureomycin dosage in metric units of weight would be inadvisable. Nevertheless, since the International Standard may not be a pure substance, a unit notation—for use where required in bioassays—is desirable, and the International Unit of Aureomycin has therefore been defined as the activity contained in one microgram of the International Standard. PMID:13141137

  7. Direct determination of N-methyl-2-pyrrolidone metabolites in urine by HPLC-electrospray ionization-MS/MS using deuterium-labeled compounds as internal standard.

    PubMed

    Suzuki, Yoshihiro; Endo, Yoko; Ogawa, Masanori; Yamamoto, Shinobu; Takeuchi, Akito; Nakagawa, Tomoo; Onda, Nobuhiko

    2009-11-01

    N-methyl-2-pyrrolidone (NMP) has been used in many industries and biological monitoring of NMP exposure is preferred to atmospheric monitoring in occupational health. We developed an analytical method that did not include solid phase extraction (SPE) but utilized deuterium-labeled compounds as internal standard for high-performance liquid chromatography-electrospray ionization-mass spectrometry using a C30 column. Urinary concentrations of NMP and its known metabolites 5-hydoxy-N-methyl-2-pyrrolidone (5-HNMP), N-methyl-succinimide (MSI), and 2-hydroxy-N-methylsuccinimide (2-HMSI) were determined in a single run. The method provided baseline separation of these compounds. Their limits of detection in 10-fold diluted urine were 0.0001, 0.006, 0.008, and 0.03 mg/L, respectively. Linear calibration covered a biological exposure index (BEI) for urinary concentration. The within-run and total precisions (CV, %) were 5.6% and 9.2% for NMP, 3.4% and 4.2% for 5-HNMP, 3.7% and 6.0% for MSI, and 6.5% and 6.9% for 2-HMSI. The method was evaluated using international external quality assessment samples, and urine samples from workers exposed to NMP in an occupational area.

  8. 78 FR 49412 - Personal Flotation Devices Labeling and Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ...The Coast Guard proposes to remove references to type codes in its regulations on the carriage and labeling of Coast Guard-approved personal flotation devices (PFDs). PFD type codes are unique to Coast Guard approval and are not well understood by the public. Removing these type codes from our regulations would facilitate future incorporation by reference of new industry consensus standards for PFD labeling that will more effectively convey safety information, and is a step toward harmonization of our regulations with PFD requirements in Canada and in other countries.

  9. IRMS detection of testosterone manipulated with 13C labeled standards in human urine by removing the labeled 13C.

    PubMed

    Wang, Jingzhu; Yang, Rui; Yang, Wenning; Liu, Xin; Xing, Yanyi; Xu, Youxuan

    2014-12-10

    Isotope ratio mass spectrometry (IRMS) is applied to confirm testosterone (T) abuse by determining the carbon isotope ratios (δ(13)C value). However, (13)C labeled standards can be used to control the δ(13)C value and produce manipulated T which cannot be detected by the current method. A method was explored to remove the (13)C labeled atom at C-3 from the molecule of androsterone (Andro), the metabolite of T in urine, to produce the resultant (A-nor-5α-androstane-2,17-dione, ANAD). The difference in δ(13)C values between Andro and ANAD (Δδ(13)CAndro-ANAD, ‰) would change significantly in case manipulated T is abused. Twenty-one volunteers administered T manipulated with different (13)C labeled standards. The collected urine samples were analyzed with the established method, and the maximum value of Δδ(13)CAndro-ANAD post ingestion ranged from 3.0‰ to 8.8‰. Based on the population reference, the cut-off value of Δδ(13)CAndro-ANAD for positive result was suggested as 1.2‰. The developed method could be used to detect T manipulated with 3-(13)C labeled standards. Copyright © 2014 Elsevier B.V. All rights reserved.

  10. SIB-DOTA: a trifunctional prosthetic group potentially amenable for multi-modal labeling that enhances tumor uptake of internalizing monoclonal antibodies.

    PubMed

    Vaidyanathan, G; White, B J; Affleck, D J; Zhao, X G; Welsh, P C; McDougald, D; Choi, J; Zalutsky, M R

    2012-12-15

    A major drawback of internalizing monoclonal antibodies (mAbs) radioiodinated with direct electrophilic approaches is that tumor retention of radioactivity is compromised by the rapid washout of iodo-tyrosine, the primary labeled catabolite for mAbs labeled via this strategy. In our continuing efforts to develop more versatile residualizing labels that could overcome this problem, we have designed SIB-DOTA, a prosthetic labeling template that combines the features of the prototypical, dehalogenation-resistant N-succinimidyl 3-iodobenzoate (SIB) with DOTA, a useful macrocyclic chelator for labeling with radiometals. Herein we describe the synthesis of the unlabeled standard of this prosthetic moiety, its protected tin precursor, and radioiodinated SIB-DOTA. An anti-EGFRvIII-reactive mAb, L8A4 was radiolabeled with [(131)I]SIB-DOTA in 27.1±6.2% (n=2) conjugation yields and its targeting properties to the same mAb labeled with [(125)I]SGMIB both in vitro and in vivo using U87MG·ΔEGFR cells and xenografts were compared. In vitro paired-label internalization assays showed that the intracellular radioactivity from [(131)I]SIB-DOTA-L8A4 was 21.4±0.5% and 26.2±1.1% of initially bound radioactivity at 16 and 24h, respectively. In comparison, these values for [(125)I]SGMIB-L8A4 were 16.7±0.5% and 14.9±1.1%. Similarly, the SIB-DOTA prosthetic group provided better tumor targeting in vivo than SGMIB over 8 d period. These results suggest that SIB-DOTA warrants further evaluation as a residualizing agent for labeling internalizing mAbs including those targeted to EGFRvIII. Copyright © 2012 Elsevier Ltd. All rights reserved.

  11. International Implications of Labeling Foods Containing Engineered Nanomaterials.

    PubMed

    Grieger, Khara D; Hansen, Steffen Foss; Mortensen, Ninell P; Cates, Sheryl; Kowalcyk, Barbara

    2016-05-01

    To provide greater transparency and comprehensive information to consumers regarding their purchase choices, the European Parliament and the Council have mandated via Regulation 1169/2011 that foods containing engineered nanomaterials (ENMs) be labeled. This review covers the main concerns related to the use of ENMs in foods and the potential impacts that this type of food labeling might have on diverse stakeholder groups, including those outside the European Union (EU), e.g., in the United States. We also provide recommendations to stakeholders for overcoming existing challenges related to labeling foods containing ENMs. The revised EU food labeling requirements will likely result in a number of positive developments and a number of challenges for stakeholders in both EU and non-EU countries. Although labeling of foods containing ENMs will likely improve transparency, provide more information to facilitate consumer decisions, and build trust among food safety authorities and consumers, critical obstacles to the successful implementation of these labeling requirements remain, including the need for (i) harmonized information requirements or regulations between countries in different regions of the world, (ii) clarification of the regulatory definitions of the ENMs to be used for food labeling, (iii) robust techniques to detect, measure, and characterize diverse ENMs in food matrices, and (iv) clarification of the list of ENMs that may be exempt from labeling requirements, such as several food additives used for decades. We recommend that food industries and food safety authorities be more proactive in communicating with the public and consumer groups regarding the potential benefits and risks of using ENMs in foods. Efforts should be made to improve harmonization of information requirements between countries to avoid potential international trade barriers.

  12. The Third International Standard for Corticotrophin

    PubMed Central

    Bangham, D. R.; Mussett, M. V.; Stack-Dunne, M. P.

    1962-01-01

    At its meeting in September 1957, the WHO Expert Committee on Biological Standardization agreed with the recommendation of the International Conference on Corticotrophin, held in July 1957, that a new international standard for corticotrophin should be set up, since the Second International Standard was made from crude material and was unsuitable for the assay of the purer preparations of corticotrophin now in general clinical use. In this paper, the authors describe the steps taken to establish the Third International Standard for Corticotrophin, from the preparation and international collaborative assay of the new material to the choice of the ”subcutaneous assay” for deriving the potency. The clinical and pharmacological implications of this choice are discussed. Since the preparation, characterization and exact quantitative assay of standards for corticotrophin are so difficult, several batches of approximately 3500 ampoules were prepared in a similar way from the same material to serve as an international Working Standard. Samples from two batches were included in the collaborative assay and found to have the same potency as the Third Standard. Sufficient ampoules of the Working Standard are available for use as national and laboratory standards. PMID:13966359

  13. Compliance and Verification of Standards and Labelling Programs in China: Lessons Learned

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

    Saheb, Yamina; Zhou, Nan; Fridley, David

    2010-06-11

    After implementing several energy efficiency standards and labels (30 products covered by MEPS, 50 products covered by voluntary labels and 19 products by mandatory labels), the China National Institute of Standardization (CNIS) is now implementing verification and compliance mechanism to ensure that the energy information of labeled products comply with the requirements of their labels. CNIS is doing so by organizing check testing on a random basis for room air-conditioners, refrigerators, motors, heaters, computer displays, ovens, and self -ballasted lamps. The purpose of the check testing is to understand the implementation of the Chinese labeling scheme and help local authoritiesmore » establishing effective compliance mechanisms. In addition, to ensure robustness and consistency of testing results, CNIS has coordinated a round robin testing for room air conditioners. Eight laboratories (Chinese (6), Australian (1) and Japanese (1)) have been involved in the round robin testing and tests were performed on four sets of samples selected from manufacturer?s production line. This paper describes the methodology used in undertaking both check and round robin testing, provides analysis of testing results and reports on the findings. The analysis of both check and round robin testing demonstrated the benefits of a regularized verification and monitoring system for both laboratories and products such as (i) identifying the possible deviations between laboratories to correct them, (ii) improving the quality of testing facilities, (iii) ensuring the accuracy and reliability of energy label information in order to strength the social credibility of the labeling program and the enforcement mechanism in place.« less

  14. Compliance and Verification of Standards and Labeling Programs in China: Lessons Learned

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

    Saheb, Yamina; Zhou, Nan; Fridley, David

    2010-08-01

    After implementing several energy efficiency standards and labels (30 products covered by MEPS, 50 products covered by voluntary labels and 19 products by mandatory labels), the China National Institute of Standardization (CNIS) is now implementing verification and compliance mechanism to ensure that the energy information of labeled products comply with the requirements of their labels. CNIS is doing so by organizing check testing on a random basis for room air-conditioners, refrigerators, motors, heaters, computer displays, ovens, and self -ballasted lamps. The purpose of the check testing is to understand the implementation of the Chinese labeling scheme and help local authoritiesmore » establishing effective compliance mechanisms. In addition, to ensure robustness and consistency of testing results, CNIS has coordinated a round robin testing for room air conditioners. Eight laboratories (Chinese (6), Australian (1) and Japanese (1)) have been involved in the round robin testing and tests were performed on four sets of samples selected from manufacturer's production line. This paper describes the methodology used in undertaking both check and round robin testing, provides analysis of testing results and reports on the findings. The analysis of both check and round robin testing demonstrated the benefits of a regularized verification and monitoring system for both laboratories and products such as (i) identifying the possible deviations between laboratories to correct them, (ii) improving the quality of testing facilities, (iii) ensuring the accuracy and reliability of energy label information in order to strength the social credibility of the labeling program and the enforcement mechanism in place.« less

  15. The International Standard for Oxytetracycline

    PubMed Central

    Humphrey, J. H.; Lightbown, J. W.; Mussett, M. V.; Perry, W. L. M.

    1955-01-01

    The first attempt to set up an international standard for oxytetracycline, using oxytetracycline hydrochloride, failed because of difficulties in obtaining a preparation whose moisture content was uniform after distribution into ampoules. A preparation of dihydrate of oxytetracycline base was obtained instead, and was compared in an international collaborative assay with a sample of oxytetracycline hydrochloride, which was the current working standard of Chas. Pfizer & Co., Inc., USA. The results of the collaborative assay showed that the potency of the dihydrate was uniform, and that it was a suitable preparation for use as the International Standard. Evidence was obtained, however, that the reference preparation at the time of examination was less potent than had been originally supposed, and that it was hydrated. The potency of the proposed international standard was recalculated after allowance for water in the reference preparation, and the resulting biological potency agreed well with that to be expected on the basis of the physicochemical properties of the preparation. It was agreed, therefore, that the recalculated values should be used, and the preparation of oxytetracycline base dihydrate used in the collaborative assay is established as the International Standard for Oxytetracycline with a potency of 900 International Units per mg. PMID:13284563

  16. Stable isotope labeling by essential nutrients in cell culture for preparation of labeled coenzyme A and its thioesters.

    PubMed

    Basu, Sankha S; Mesaros, Clementina; Gelhaus, Stacy L; Blair, Ian A

    2011-02-15

    Stable isotope dilution mass spectrometry (MS) represents the gold standard for quantification of endogenously formed cellular metabolites. Although coenzyme A (CoA) and acyl-CoA thioester derivatives are central players in numerous metabolic pathways, the lack of a commercially available isotopically labeled CoA limits the development of rigorous MS-based methods. In this study, we adapted stable isotope labeling by amino acids in cell culture (SILAC) methodology to biosynthetically generate stable isotope labeled CoA and thioester analogues for use as internal standards in liquid chromatography/multiple reaction monitoring mass spectrometry (LC/MRM-MS) assays. This was accomplished by incubating murine hepatocytes (Hepa 1c1c7) in media in which pantothenate (a precursor of CoA) was replaced with [(13)C(3)(15)N(1)]-pantothenate. Efficient incorporation into various CoA species was optimized to >99% [(13)C(3)(15)N(1)]-pantothenate after three passages of the murine cells in culture. Charcoal-dextran-stripped fetal bovine serum (FBS) was found to be more efficient for serum supplementation than dialyzed or undialyzed FBS, due to lower contaminating unlabeled pantothenate content. Stable isotope labeled CoA species were extracted and utilized as internal standards for CoA thioester analysis in cell culture models. This methodology of stable isotope labeling by essential nutrients in cell culture (SILEC) can serve as a paradigm for using vitamins and other essential nutrients to generate stable isotope standards that cannot be readily synthesized.

  17. Predictors of awareness of standard drink labelling and drinking guidelines to reduce negative health effects among Australian drinkers.

    PubMed

    Coomber, Kerri; Jones, Sandra C; Martino, Florentine; Miller, Peter G

    2017-03-01

    This study examined rates of awareness of standard drink labelling and drinking guidelines among Australian adult drinkers. Demographic predictors of these two outcomes were also explored. Online survey panel participants aged 18-45 years(n = 1061; mean age = 33.2 years) completed an online survey assessing demographics, alcohol consumption patterns, awareness of standard drink labels and the National Health and Medical Research Council (NHMRC) guidelines, and support for more detailed labels. The majority (80%) of participants had seen standard drink labels on alcohol products; with younger drinkers, those from a regional/rural location and high-risk drinkers significantly more likely to have seen such labelling. Most respondents estimated at or below the maximum number of drinks stipulated in the NHMRC guidelines. However, their estimates of the levels for male drinkers were significantly higher than for female drinkers. High-risk drinkers were significantly less likely to provide accurate estimates, while those who had seen the standard drink logo were significantly more likely to provide accurate estimates of drinking levels to reduce the risk of long-term harms only. Just under three-quarters of respondents supported the inclusion of more information on labels regarding guidelines to reduce negative health effects. The current standard drink labelling approach fails to address high-risk drinkers. The inclusion of information about NHMRC guidelines on alcohol labels, and placing standard drink labelling on the front of products could improve awareness of what constitutes a standard drink and safe levels of consumption among Australian drinkers.[Kerri Coomber, Sandra C. Jones, Florentine Martino, Peter G. Miller. Predictors of awareness of standard drink labelling and drinking guidelines to reduce negative health effects among Australian drinkers. Drug Alcohol Rev 2017;36:200-209]. © 2016 Australasian Professional Society on Alcohol and other Drugs.

  18. The Second International Standard for Penicillin*

    PubMed Central

    Humphrey, J. H.; Mussett, M. V.; Perry, W. L. M.

    1953-01-01

    In 1950 the Department of Biological Standards, National Institute for Medical Research, London, was authorized by the WHO Expert Committee on Biological Standardization to prepare the Second International Standard for Penicillin. A single batch of specially recrystallized sodium penicillin G was obtained and 11 laboratories in seven different countries were requested to take part in its collaborative assay. 112 assays were carried out, of which 101 were done by cup-plate methods using either Staphylococcus aureus or Bacillus subtilis. The results were subjected to standard methods of analysis, on the basis of which the authors define the Second International Standard for Penicillin as containing 1,670 International Units (IU) per mg, with limits of error (P = 0.05) of 1,666-1,674 IU/mg. The International Unit is therefore redefined as the activity contained in 0.0005988 mg of the Second International Standard for Penicillin. PMID:13082387

  19. A label-free internal standard method for the differential analysis of bioactive lupin proteins using nano HPLC-Chip coupled with Ion Trap mass spectrometry.

    PubMed

    Brambilla, Francesca; Resta, Donatella; Isak, Ilena; Zanotti, Marco; Arnoldi, Anna

    2009-01-01

    Quantitative proteomics based on MS is useful for pointing out the differences in some food proteomes relevant to human nutrition. Stable isotope label-free (SIF) techniques are suitable for comparing an unlimited number of samples by the use of relatively simple experimental workflows. We have developed an internal standard label-free method based on the intensities of peptide precursor ions from MS/MS spectra, collected in data dependent runs, for the simultaneous qualitative characterization and relative quantification of storage proteins of Lupinus albus seeds in protein extracts of four lupin cultivars (cv Adam, Arés, Lucky, Multitalia). The use of an innovative microfluidic system, the HPLC-Chip, coupled with a classical IT mass spectrometer, has allowed a complete qualitative characterization of all proteins. In particular, the homology search mode has permitted to identify single amino acid substitutions in the sequences of vicilins (beta-conglutin precursor and vicilin-like protein). The MS/MS sequencing of substituted peptides confirms the high heterogeneity of vicilins according to the peculiar characteristics of the vicilin-encoding gene family. Two suitable bioinformatics parameters were optimized for the differential analyses of the main bioactive proteins: the "normalized protein average of common reproducible peptides" (N-ACRP) for gamma-conglutin, which is a homogeneous protein, and the "normalized protein mean peptide spectral intensity" (N-MEAN) for the highly heterogenous class of the vicilins.

  20. International aerospace standards - An overview

    NASA Astrophysics Data System (ADS)

    Mason, J. L.

    1983-10-01

    Factors to be considered in adopting and extending international standards in the U.S. aerospace industry are reviewed. Cost-related advantages and disadvantages of standardization are weighed, and further obstacles are identified in the English/metric rivalry and the pacing of metrification. The problem of standard duplication is examined, and the issue of revenues from the sale of copyrighted documents describing standards is addressed. It is recommended that international metric-system standards be introduced, with proper timing, wherever possible, and that prompt negotiations be undertaken to prevent or resolve document-sales disagreements. The continuation of English-system standards for safety-related cockpit readouts and communications systems is suggested.

  1. Status of the Local Enforcement of Energy Efficiency Standards and Labeling Program in China

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

    Zhou, Nan; Zheng, Nina; Fino-Chen, Cecilia

    2011-09-26

    As part of its commitment to promoting and improving the local enforcement of appliance energy efficiency standards and labeling, the China National Institute of Standardization (CNIS) launched the National and Local Enforcement of Energy Efficiency Standards and Labeling project on August 14, 2009. The project’s short-term goal is to expand the effort to improve enforcement of standards and labeling requirements to the entire country within three years, with a long-term goal of perfecting overall enforcement. For this project, Jiangsu, Shandong, Sichuan and Shanghai were selected as pilot locations. This report provides information on the local enforcement project’s recent background, activitiesmore » and results as well as comparison to previous rounds of check-testing in 2006 and 2007. In addition, the report also offers evaluation on the achievement and weaknesses in the local enforcement scheme and recommendations. The results demonstrate both improvement and some backsliding. Enforcement schemes are in place in all target cities and applicable national standards and regulations were followed as the basis for local check testing. Check testing results show in general high labeling compliance across regions with 100% compliance for five products, including full compliance for all three products tested in Jiangsu province and two out of three products tested in Shandong province. Program results also identified key weaknesses in labeling compliance in Sichuan as well as in the efficiency standards compliance levels for small and medium three-phase asynchronous motors and self-ballasted fluorescent lamps. For example, compliance for the same product ranged from as low as 40% to 100% with mixed results for products that had been tested in previous rounds. For refrigerators, in particular, the efficiency standards compliance rate exhibited a wider range of 50% to 100%, and the average rate across all tested models also dropped from 96% in 2007 to 63

  2. International standards in mitigating trade risks.

    PubMed

    Thiermann, A B

    2011-04-01

    This paper describes the role of the World Organisation for Animal Health (OIE), as a science-based and democratic standard-setting organisation that provides guidance on preventing the spread of animal diseases, including zoonoses, in international trade. The World Trade Organization is identified as the international institution with the legal power to encourage adherence to international standards and mediate trade disputes. The importance of assuring good governance and the credibility of national Veterinary Services through a process of official certification is identified as an essential component in the safety of trade. Private-public partnerships and the evolution of responsibilities are also identified as essential for the implementation of health guarantees such as compartmentalisation. The rapid emergence of private standards is described as a potential complement to the implementation of sanitary standards, as long as they are applied globally and in support of the OIE standards. Ultimately, the biggest challenge is for the international community to create the incentives and generate the political will for fair trade and for the universal recognition and application of the established international sanitary standards.

  3. INTERNATIONAL REPORTS: New International Standards for Quantities and Units

    NASA Astrophysics Data System (ADS)

    Thor, A. J.

    1994-01-01

    Each coherent system of units is based on a system of quantities in such a way that the equations between the numerical values expressed in coherent units have exactly the same form, including numerical factors, as the corresponding equations between the quantities. The highest international body responsible for the International System of Units (SI) is the Conférence Générale des Poids et Mesures (CGPM). However, the CGPM is not concerned with quantities or systems of quantities. That question lies within the scope of Technical Committee number twelve of the International Organization for Standardization (ISO/TC 12). Quantities, units, symbols, conversion factors. To fulfil its responsibility, ISO/TC 12 has prepared the International Standard ISO 31, Quantities and Units, which consists of fourteen parts. The new editions of the different parts of the International Standard are briefly presented here.

  4. 78 FR 63873 - Minimum Internal Control Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... Internal Control Standards AGENCY: National Indian Gaming Commission, Interior. ACTION: Final rule. SUMMARY: The National Indian Gaming Commission (NIGC) amends its minimum internal control standards for Class... Internal Control Standards. 64 FR 590. The rule added a new part to the Commission's regulations...

  5. 78 FR 11793 - Minimum Internal Control Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... Internal Control Standards AGENCY: National Indian Gaming Commission. ACTION: Proposed rule. SUMMARY: The National Indian Gaming Commission (NIGC) proposes to amend its minimum internal control standards for Class... NIGC published a final rule in the Federal Register called Minimum Internal Control Standards. 64 FR...

  6. 77 FR 32444 - Minimum Internal Control Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... Internal Control Standards AGENCY: National Indian Gaming Commission. ACTION: Proposed rule. SUMMARY: The National Indian Gaming Commission (NIGC) proposes to amend its minimum internal control standards for Class... the Federal Register called Minimum Internal Control Standards. 64 FR 590. The rule added a new part...

  7. Third International Standard for Posterior Pituitary

    PubMed Central

    Bangham, D. R.; Mussett, Marjorie V.

    1958-01-01

    In October 1955, stocks of the Second International Standard for Posterior Pituitary were running low and the Department of Biological Standards of the National Institute for Medical Research, London, was asked to proceed with the arrangements for an international collaborative assay of material for the Third Standard. A single 142-g batch of posterior-pituitary-lobe powder was obtained and distributed in ampoules, in approximately 30-mg quantities. Samples were sent to 19 laboratories in 10 countries. In all, 185 assays were carried out, 122 for oxytocic activity, 53 for vasopressor activity and 10 for antidiuretic activity. On the basis of the results, which were analysed statistically at the National Institute for Medical Research, it was agreed that the potency of the Third Standard (re-named International Standard for Oxytocic, Vasopressor and Antidiuretic Substances in 1956, in view of the recent synthesis of oxytocin and vasopressin) should be expressed as 2.0 International Units per milligram. The International Unit therefore remains unchanged as 0.5 mg of the dry powder. PMID:13585079

  8. 77 FR 43196 - Minimum Internal Control Standards and Technical Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-24

    ... NATIONAL INDIAN GAMING COMMISSION 25 CFR Parts 543 and 547 Minimum Internal Control Standards [email protected] . SUPPLEMENTARY INFORMATION: Part 543 addresses minimum internal control standards (MICS) for Class II gaming operations. The regulations require tribes to establish controls and implement...

  9. UHPLC-MS/MS method for the quantitation of penicillin G and metabolites in citrus fruit using internal standards.

    PubMed

    Canzani, Daniele; Hsieh, Kevin; Standland, Matthew; Hammack, Walter; Aldeek, Fadi

    2017-02-15

    Penicillin G has been applied to citrus trees as a potential treatment in the fight against Huanglongbing (HLB). Here, we have developed and validated a method to identify and quantitate penicillin G and two of its metabolites, penillic acid and penilloic acid, in citrus fruit using ultra high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS). This method improves upon a previous method by incorporating isotopically labeled internal standards, namely, penillic acid-D 5 , and penilloic acid-D 5 . These standards greatly enhanced the accuracy and precision of our measurements by compensating for recovery losses, degradation, and matrix effects. When 2g of citrus fruit sample is extracted, the limits of detection (LOD) were determined to be 0.1ng/g for penicillin G and penilloic acid, and 0.25ng/g for penillic acid. At fortification levels of 0.1, 0.25, 1, and 10ng/g, absolute recoveries for penillic and penilloic acids were generally between 50-70%. Recoveries corrected with the isotopically labeled standards were approximately 90-110%. This method will be useful for the identification and quantitation of drug residues and their degradation products using isotopically labeled standards and UHPLC-MS/MS. Published by Elsevier B.V.

  10. The second international standard for polymyxin B.

    PubMed

    Lightbown, J W; Thomas, A H; Grab, B; Outschoorn, A S

    1973-01-01

    Since supplies of the first International Standard for Polymyxin B were exhausted, it was replaced by a second international standard the potency of which was estimated from the results of a collaborative assay carried out by 5 laboratories in 4 countries. The wide variations in the results probably resulted from difficulties experienced in handling the first international standard. The potency finally agreed upon by the collaborating laboratories, on the basis of the overall mean values obtained after rejection of the most discrepant assays, was 8 403 IU/mg. That value was accepted by the WHO Expert Committee on Biological Standardization (1970), which consequently defined the International Unit of polymyxin B as the activity contained in 0.000119 mg of the second international standard.

  11. The second international standard for polymyxin B*

    PubMed Central

    Lightbown, J. W.; Thomas, A. H.; Grab, B.; Outschoorn, A. S.

    1973-01-01

    Since supplies of the first International Standard for Polymyxin B were exhausted, it was replaced by a second international standard the potency of which was estimated from the results of a collaborative assay carried out by 5 laboratories in 4 countries. The wide variations in the results probably resulted from difficulties experienced in handling the first international standard. The potency finally agreed upon by the collaborating laboratories, on the basis of the overall mean values obtained after rejection of the most discrepant assays, was 8 403 IU/mg. That value was accepted by the WHO Expert Committee on Biological Standardization (1970), which consequently defined the International Unit of polymyxin B as the activity contained in 0.000119 mg of the second international standard. PMID:4350877

  12. Status of international optical disk standards

    NASA Astrophysics Data System (ADS)

    Chen, Di; Neumann, John

    1999-11-01

    Optical technology for data storage offers media removability with unsurpassed reliability. As the media are removable, data interchange between the media and drives from different sources is a major concern. The optical recording community realized, at the inception of this new storage technology development, that international standards for all optical recording disk/cartridge must be established to insure the healthy growth of this industry and for the benefit of the users. Many standards organizations took up the challenge and numerous international standards were established which are now being used world-wide. This paper provides a brief summary of the current status of the international optical disk standards.

  13. The international standard for colistin*

    PubMed Central

    Lightbown, J. W.; Bond, J. M.; Grab, B.

    1973-01-01

    An International Standard for Colistin has been established and the International Unit defined as the activity contained in 0.00004878 mg of this preparation. The unit was defined on the basis of a collaborative assay in which nine laboratories from six different countries participated. The material used to prepare the international standard had been manufactured in Japan; it was shown to have a composition similar to that of material produced in Europe and to be suitable for the assay of colistin from the existing sources of manufacture. PMID:4541149

  14. Energy Efficiency standards and labels provide a solid foundationfor economic growth, climate change mitigation, and regional trade

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

    Wiel, Stephen; Egan, Christine; della Cava, Mirka

    2006-09-01

    Governments around the world have increasingly beenimplementing energy efficiency standards and labeling programs for thepast 30 years. There has been an especially rapid growth in the numberand extent of these programs over the past 15 years. By the end of 2005,62 countries had adopted 1818 separate standards or labels covering 82products. The impact has been dramatic. This paper describes: (1) thebenefits that can be obtained through this policy, (2) which countriesare implementing standards and labels and for which products, (3) theimpacts such programs have been having in some countries, and (4) recentprogress through regional cooperation and alignment.

  15. Use of phenyl/tetrazolyl-functionalized magnetic microspheres and stable isotope labeled internal standards for significant reduction of matrix effect in determination of nine fluoroquinolones by liquid chromatography-quadrupole linear ion trap mass spectrometry.

    PubMed

    Xu, Fei; Liu, Feng; Wang, Chaozhan; Wei, Yinmao

    2018-02-01

    In this study, the strategy of unique adsorbent combined with isotope labeled internal standards was used to significantly reduce the matrix effect for the enrichment and analysis of nine fluoroquinolones in a complex sample by liquid chromatography coupled to quadrupole linear ion trap mass spectrometry (LC-QqQ LIT -MS/MS). The adsorbent was prepared conveniently by functionalizing Fe 3 O 4 @SiO 2 microspheres with phenyl and tetrazolyl groups, which could adsorb fluoroquinolones selectively via hydrophobic, electrostatic, and π-π interactions. The established magnetic solid-phase extraction (MSPE) method as well as using stable isotope labeled internal standards in the next MS/MS detection was able to reduce the matrix effect significantly. In the process of LC-QqQ LIT -MS/MS analysis, the precursor and product ions of the analytes were monitored quantitatively and qualitatively on a QTrap system equipped simultaneously with the multiple reaction monitoring (MRM) and enhanced product ion (EPI) scan. Subsequently, the enrichment method combined with LC-QqQ LIT -MS/MS demonstrated good analytical features in terms of linearity (7.5-100.0 ng mL -1 , r > 0.9960), satisfactory recoveries (88.6%-118.3%) with RSDs < 12.0%, LODs = 0.5 μg kg -1 and LOQs = 1.5 μg kg -1 for all tested analytes. Finally, the developed MSPE-LC-QqQ LIT -MS/MS method had been successfully applied to real pork samples for food-safety risk monitoring in Ningxia Province, China. Graphical abstract Mechanism of reducing matrix effect through the as-prepared adsorbent.

  16. 77 FR 58707 - Minimum Internal Control Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-21

    ... Gaming Commission 25 CFR Part 543 Minimum Internal Control Standards; Final Rule #0;#0;Federal Register... Control Standards AGENCY: National Indian Gaming Commission, Interior. ACTION: Final rule. SUMMARY: The National Indian Gaming Commission (NIGC) amends its minimum internal control standards for Class II gaming...

  17. The impact of more visible standard drink labelling on youth alcohol consumption: helping young people drink (ir)responsibly?

    PubMed

    Jones, Sandra C; Gregory, Parri

    2009-05-01

    In response to increasing concerns about excessive drinking among young people the Australian alcohol industry announced that it will introduce more visible standard drink labels. This study sought to examine whether young people use this information in a way that decreases, or increases, alcohol-related harms. Six focus groups with students enrolled in an undergraduate university course in a large regional city in New South Wales, recruited by direct approach on the university grounds and via an online message posted on the university bulletin board. The majority of the participants reported that they are aware of the existence of standard drink labelling; notice standard drink labels; and take these into account when choosing what to purchase. However, this was predominantly to help them choose the strongest drinks for the lowest cost. This study provides initial evidence to support the view that standard drink labelling, in isolation of other modifications to product packaging and marketing, is likely to serve to further increase heavy drinking among young people.

  18. Australia's double standard on Thailand's alcohol warning labels.

    PubMed

    O'Brien, Paula

    2013-01-01

    Since 2010, members of the World Trade Organization (WTO), including Australia, have opposed Thailand's proposal for graphic warnings on alcohol containers. This paper aims to provide an account of the arguments for/against Thailand and to examine the arguments' legal and political validity. This paper reviews primary WTO records in relation to Thailand's proposal to reveal the arguments for/against Thailand's proposal. The paper analyses these arguments in light of WTO cases to identify the legal strengths and weaknesses of Thailand's position. The paper then considers whether the attacks on Thailand by Australia are justified in light of the Australian Government's position on (i) alcohol warning labels in Australia and (ii) tobacco plain packaging. The legal arguments against Thailand are: only harmful alcohol consumption should be prevented; there is no evidence that graphic warning labels can reduce alcohol-related harm; the labels unnecessarily restrict international trade. There are some legal weaknesses in Thailand's proposal. Yet, Australia's opposition to Thailand cannot be justified whilst Australia is (i) mandating pregnancy-related alcohol warnings in Australia and (ii) defending its plain packaging law against similar WTO attacks. No WTO member is obliged to challenge another member for being non-compliant. The case tests the willingness of WTO members like Australia to respect the autonomy of other countries to pursue their public health goals and trial novel interventions. Australia's actions suggest it is willing to protect its alcohol industry at the expense of public health in Thailand. © 2012 Australasian Professional Society on Alcohol and other Drugs.

  19. Precise quantitation of 136 urinary proteins by LC/MRM-MS using stable isotope labeled peptides as internal standards for biomarker discovery and/or verification studies.

    PubMed

    Percy, Andrew J; Yang, Juncong; Hardie, Darryl B; Chambers, Andrew G; Tamura-Wells, Jessica; Borchers, Christoph H

    2015-06-15

    Spurred on by the growing demand for panels of validated disease biomarkers, increasing efforts have focused on advancing qualitative and quantitative tools for more highly multiplexed and sensitive analyses of a multitude of analytes in various human biofluids. In quantitative proteomics, evolving strategies involve the use of the targeted multiple reaction monitoring (MRM) mode of mass spectrometry (MS) with stable isotope-labeled standards (SIS) used for internal normalization. Using that preferred approach with non-invasive urine samples, we have systematically advanced and rigorously assessed the methodology toward the precise quantitation of the largest, multiplexed panel of candidate protein biomarkers in human urine to date. The concentrations of the 136 proteins span >5 orders of magnitude (from 8.6 μg/mL to 25 pg/mL), with average CVs of 8.6% over process triplicate. Detailed here is our quantitative method, the analysis strategy, a feasibility application to prostate cancer samples, and a discussion of the utility of this method in translational studies. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. The International Standard for Anti-Brucella abortus Serum

    PubMed Central

    Stableforth, A. W.

    1954-01-01

    In field trials on the eradication of brucellosis from dairy herds in Great Britain, which began in 1933, a serum standard of reference was used for the examination of agglutinating suspensions prepared in different laboratories. In 1937, the Office International des Epizooties (OIE) adopted this standard and made recommendations for its use internationally. These recommendations were revised by OIE in 1948, by the Third Inter-American Congress on Brucellosis and by the Joint FAO/WHO Expert Panel on Brucellosis in 1950, and again by the latter body in 1952. A new batch equivalent in potency to the original standard was established by the WHO Expert Committee on Biological Standardization in 1952 as the International Standard for Anti-Brucella abortus Serum. The International Standard, or a national standard of equivalent potency, ensures comparability of the titres obtained in different countries by different methods, and the results of such comparisons can be expressed in a simple manner by describing the titres in terms of International Units of Brucella antibody. PMID:13199656

  1. To label or not to label: applications of quantitative proteomics in neuroscience research.

    PubMed

    Filiou, Michaela D; Martins-de-Souza, Daniel; Guest, Paul C; Bahn, Sabine; Turck, Christoph W

    2012-02-01

    Proteomics has provided researchers with a sophisticated toolbox of labeling-based and label-free quantitative methods. These are now being applied in neuroscience research where they have already contributed to the elucidation of fundamental mechanisms and the discovery of candidate biomarkers. In this review, we evaluate and compare labeling-based and label-free quantitative proteomic techniques for applications in neuroscience research. We discuss the considerations required for the analysis of brain and central nervous system specimens, the experimental design of quantitative proteomic workflows as well as the feasibility, advantages, and disadvantages of the available techniques for neuroscience-oriented questions. Furthermore, we assess the use of labeled standards as internal controls for comparative studies in humans and review applications of labeling-based and label-free mass spectrometry approaches in relevant model organisms and human subjects. Providing a comprehensive guide of feasible and meaningful quantitative proteomic methodologies for neuroscience research is crucial not only for overcoming current limitations but also for gaining useful insights into brain function and translating proteomics from bench to bedside. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  2. Pressure Sensitive Tape and Label Surface Coating Industry: New Source Performance Standards (NSPS)

    EPA Pesticide Factsheets

    Learn about the New Source Performance Standards (NSPS) for pressure sensitive tape and label surface coating. Read the rule summary and history, and find the code of federal regulations and federal register citations.

  3. Housekeeping genes as internal standards: use and limits.

    PubMed

    Thellin, O; Zorzi, W; Lakaye, B; De Borman, B; Coumans, B; Hennen, G; Grisar, T; Igout, A; Heinen, E

    1999-10-08

    Quantitative studies are commonly realised in the biomedical research to compare RNA expression in different experimental or clinical conditions. These quantifications are performed through their comparison to the expression of the housekeeping gene transcripts like glyceraldehyde-3-phosphate dehydrogenase (G3PDH), albumin, actins, tubulins, cyclophilin, hypoxantine phsophoribosyltransferase (HRPT), L32. 28S, and 18S rRNAs are also used as internal standards. In this paper, it is recalled that the commonly used internal standards can quantitatively vary in response to various factors. Possible variations are illustrated using three experimental examples. Preferred types of internal standards are then proposed for each of these samples and thereafter the general procedure concerning the choice of an internal standard and the way to manage its uses are discussed.

  4. Data Availability in Appliance Standards and Labeling Program Development and Evaluation

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

    Romankiewicz, John; Khanna, Nina; Vine, Edward

    2013-05-01

    In this report, we describe the necessary data inputs for both standards development and program evaluation and perform an initial assessment of the availability and uncertainty of those data inputs in China. For standards development, we find that China and its standards and labeling program administrators currently has access to the basic market and technical data needed for conducting market and technology assessment and technological and economic analyses. Some data, such as shipments data, is readily available from the China Energy Label product registration database while the availability of other data, including average unit energy consumption, prices and design options,more » needs improvement. Unlike some other countries such as the United States, most of the necessary data for conducting standards development analyses are not publicly available or compiled in a consolidated data source. In addition, improved data on design and efficiency options as well as cost data (e.g., manufacturing costs, mark-ups, production and product use-phase costs) – key inputs to several technoeconomic analyses – are particularly in need given China’s unconsolidated manufacturing industry. For program evaluation, we find that while China can conduct simple savings evaluations on its incentive programs with the data it currently has available from the Ministry of Finance – the program administrator, the savings estimates produced by such an evaluation will carry high uncertainty. As such, China could benefit from an increase in surveying and metering in the next one to three years to decrease the uncertainty surrounding key data points such as unit energy savings and free ridership.« less

  5. Occupational Standards: International Perspectives.

    ERIC Educational Resources Information Center

    Oliveira, Joao, Ed.

    These nine papers from a conference of the International Research Network for Training and Development focus on occupational classification, standards, and certification. "Introduction" (Joao Oliveria) presents synopses with highlights from the papers. Part I offers an overview of recent developments in the United States in…

  6. Measuring the labeling efficiency of pseudocontinuous arterial spin labeling.

    PubMed

    Chen, Zhensen; Zhang, Xingxing; Yuan, Chun; Zhao, Xihai; van Osch, Matthias J P

    2017-05-01

    Optimization and validation of a sequence for measuring the labeling efficiency of pseudocontinuous arterial spin labeling (pCASL) perfusion MRI. The proposed sequence consists of a labeling module and a single slice Look-Locker echo planar imaging readout. A model-based algorithm was used to calculate labeling efficiency from the signal acquired from the main brain-feeding arteries. Stability of the labeling efficiency measurement was evaluated with regard to the use of cardiac triggering, flow compensation and vein signal suppression. Accuracy of the measurement was assessed by comparing the measured labeling efficiency to mean brain pCASL signal intensity over a wide range of flip angles as applied in the pCASL labeling. Simulations show that the proposed algorithm can effectively calculate labeling efficiency when correcting for T1 relaxation of the blood spins. Use of cardiac triggering and vein signal suppression improved stability of the labeling efficiency measurement, while flow compensation resulted in little improvement. The measured labeling efficiency was found to be linearly (R = 0.973; P < 0.001) related to brain pCASL signal intensity over a wide range of pCASL flip angles. The optimized labeling efficiency sequence provides robust artery-specific labeling efficiency measurement within a short acquisition time (∼30 s), thereby enabling improved accuracy of pCASL CBF quantification. Magn Reson Med 77:1841-1852, 2017. © 2016 International Society for Magnetic Resonance in Medicine Magn Reson Med 77:1841-1852, 2017. © 2016 International Society for Magnetic Resonance in Medicine. © 2016 International Society for Magnetic Resonance in Medicine.

  7. 75 FR 19944 - International Code Council: The Update Process for the International Codes and Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-16

    ... for Residential Construction in High Wind Areas. ICC 700: National Green Building Standard. The... Codes and Standards that are comprehensive, coordinated, and necessary to regulate the built environment... International Codes and Standards consist of the following: ICC Codes International Building Code. International...

  8. International Organization for Standardization (ISO) 15189

    PubMed Central

    Schneider, Frank; Friedberg, Richard C.

    2017-01-01

    The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189. PMID:28643484

  9. The influence of international standards on optomechanical design

    NASA Astrophysics Data System (ADS)

    Parks, Robert E.

    1992-12-01

    In the last 10 to 15 years, a considerable body of international standards literature has been published on both mechanical and optical design. We discuss the influence of these internationally developed standards on the design and fabrication of optical systems. We conclude that while there are large benefits to be gained from using these international standards, there will have to be a substantial educational effort at all levels from project scientist to worker on the shop floor to take advantage of the benefits. Many sources to help in this education process are outlined.

  10. A new dimethyl labeling-based SID-MRM-MS method and its application to three proteases involved in insulin maturation.

    PubMed

    Cheng, Dongwan; Zheng, Li; Hou, Junjie; Wang, Jifeng; Xue, Peng; Yang, Fuquan; Xu, Tao

    2015-01-01

    The absolute quantification of target proteins in proteomics involves stable isotope dilution coupled with multiple reactions monitoring mass spectrometry (SID-MRM-MS). The successful preparation of stable isotope-labeled internal standard peptides is an important prerequisite for the SID-MRM absolute quantification methods. Dimethyl labeling has been widely used in relative quantitative proteomics and it is fast, simple, reliable, cost-effective, and applicable to any protein sample, making it an ideal candidate method for the preparation of stable isotope-labeled internal standards. MRM mass spectrometry is of high sensitivity, specificity, and throughput characteristics and can quantify multiple proteins simultaneously, including low-abundance proteins in precious samples such as pancreatic islets. In this study, a new method for the absolute quantification of three proteases involved in insulin maturation, namely PC1/3, PC2 and CPE, was developed by coupling a stable isotope dimethyl labeling strategy for internal standard peptide preparation with SID-MRM-MS quantitative technology. This method offers a new and effective approach for deep understanding of the functional status of pancreatic β cells and pathogenesis in diabetes.

  11. International Organization for Standardization (ISO) 15189.

    PubMed

    Schneider, Frank; Maurer, Caroline; Friedberg, Richard C

    2017-09-01

    The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189. © The Korean Society for Laboratory Medicine.

  12. Site-specific labeling of RNA at internal ribose hydroxyl groups: terbium-assisted deoxyribozymes at work.

    PubMed

    Büttner, Lea; Javadi-Zarnaghi, Fatemeh; Höbartner, Claudia

    2014-06-04

    A general and efficient single-step method was established for site-specific post-transcriptional labeling of RNA. Using Tb(3+) as accelerating cofactor for deoxyribozymes, various labeled guanosines were site-specifically attached to 2'-OH groups of internal adenosines in in vitro transcribed RNA. The DNA-catalyzed 2',5'-phosphodiester bond formation proceeded efficiently with fluorescent, spin-labeled, biotinylated, or cross-linker-modified guanosine triphosphates. The sequence context of the labeling site was systematically analyzed by mutating the nucleotides flanking the targeted adenosine. Labeling of adenosines in a purine-rich environment showed the fastest reactions and highest yields. Overall, practically useful yields >70% were obtained for 13 out of 16 possible nucleotide (nt) combinations. Using this approach, we demonstrate preparative labeling under mild conditions for up to ~160-nt-long RNAs, including spliceosomal U6 small nuclear RNA and a cyclic-di-AMP binding riboswitch RNA.

  13. Standardized sign-out reduces intern perception of medical errors on the general internal medicine ward.

    PubMed

    Salerno, Stephen M; Arnett, Michael V; Domanski, Jeremy P

    2009-01-01

    Prior research on reducing variation in housestaff handoff procedures have depended on proprietary checkout software. Use of low-technology standardization techniques has not been widely studied. We wished to determine if standardizing the process of intern sign-out using low-technology sign-out tools could reduce perception of errors and missing handoff data. We conducted a pre-post prospective study of a cohort of 34 interns on a general internal medicine ward. Night interns coming off duty and day interns reassuming care were surveyed on their perception of erroneous sign-out data, mistakes made by the night intern overnight, and occurrences unanticipated by sign-out. Trainee satisfaction with the sign-out process was assessed with a 5-point Likert survey. There were 399 intern surveys performed 8 weeks before and 6 weeks after the introduction of a standardized sign-out form. The response rate was 95% for the night interns and 70% for the interns reassuming care in the morning. After the standardized form was introduced, night interns were significantly (p < .003) less likely to detect missing sign-out data including missing important diseases, contingency plans, or medications. Standardized sign-out did not significantly alter the frequency of dropped tasks or missed lab and X-ray data as perceived by the night intern. However, the day teams thought there were significantly less perceived errors on the part of the night intern (p = .001) after introduction of the standardized sign-out sheet. There was no difference in mean Likert scores of resident satisfaction with sign-out before and after the intervention. Standardized written sign-out sheets significantly improve the completeness and effectiveness of handoffs between night and day interns. Further research is needed to determine if these process improvements are related to better patient outcomes.

  14. 46 CFR 108.503 - Relationship to international standards.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Relationship to international standards. 108.503 Section 108.503 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) A-MOBILE OFFSHORE DRILLING UNITS DESIGN AND EQUIPMENT Lifesaving Equipment § 108.503 Relationship to international standards. For...

  15. Design of Standards and Labeling programs in Chile: Techno-Economic Analysis for Refrigerators

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

    Letschert, Virginie E.; McNeil, Michael A.; Pavon, Mariana

    2013-05-01

    Lawrence Berkeley National Laboratory is a global leader in the study of energy efficiency and its effective implementation through government policy. The Energy Analysis and Environmental Impacts Department of LBNL’s Environmental Energy Technologies Division provides technical assistance to help federal, stat e and local government agencies in the United States, and throughout the world, develop long-term strategies, policy, and programs to encourage energy efficiency in all sectors and industries. In the past, LBNL has assisted staff of various countries government agencies and their con tractors in providing methodologies to analyze cost-effectiveness of regulations and asses s overall national impacts ofmore » efficiency programs. The paper presents the work done in collaboration with the Ministry of Energy (MoE) in Chile and the Collaborative Labeling Appliance Standards Programs (CLASP) on designing a Minimum Energy Performance Standards (MEPS) and ext ending the current labeling program for refrigerators.« less

  16. 46 CFR 133.03 - Relationship to international standards.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 4 2011-10-01 2011-10-01 false Relationship to international standards. 133.03 Section 133.03 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS LIFESAVING SYSTEMS General § 133.03 Relationship to international standards. This subpart and subpart B of...

  17. 46 CFR 133.03 - Relationship to international standards.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 4 2014-10-01 2014-10-01 false Relationship to international standards. 133.03 Section 133.03 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS LIFESAVING SYSTEMS General § 133.03 Relationship to international standards. This subpart and subpart B of...

  18. 46 CFR 133.03 - Relationship to international standards.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 4 2012-10-01 2012-10-01 false Relationship to international standards. 133.03 Section 133.03 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS LIFESAVING SYSTEMS General § 133.03 Relationship to international standards. This subpart and subpart B of...

  19. 46 CFR 133.03 - Relationship to international standards.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Relationship to international standards. 133.03 Section 133.03 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS LIFESAVING SYSTEMS General § 133.03 Relationship to international standards. This subpart and subpart B of...

  20. Benchmarking quantitative label-free LC-MS data processing workflows using a complex spiked proteomic standard dataset.

    PubMed

    Ramus, Claire; Hovasse, Agnès; Marcellin, Marlène; Hesse, Anne-Marie; Mouton-Barbosa, Emmanuelle; Bouyssié, David; Vaca, Sebastian; Carapito, Christine; Chaoui, Karima; Bruley, Christophe; Garin, Jérôme; Cianférani, Sarah; Ferro, Myriam; Van Dorssaeler, Alain; Burlet-Schiltz, Odile; Schaeffer, Christine; Couté, Yohann; Gonzalez de Peredo, Anne

    2016-01-30

    Proteomic workflows based on nanoLC-MS/MS data-dependent-acquisition analysis have progressed tremendously in recent years. High-resolution and fast sequencing instruments have enabled the use of label-free quantitative methods, based either on spectral counting or on MS signal analysis, which appear as an attractive way to analyze differential protein expression in complex biological samples. However, the computational processing of the data for label-free quantification still remains a challenge. Here, we used a proteomic standard composed of an equimolar mixture of 48 human proteins (Sigma UPS1) spiked at different concentrations into a background of yeast cell lysate to benchmark several label-free quantitative workflows, involving different software packages developed in recent years. This experimental design allowed to finely assess their performances in terms of sensitivity and false discovery rate, by measuring the number of true and false-positive (respectively UPS1 or yeast background proteins found as differential). The spiked standard dataset has been deposited to the ProteomeXchange repository with the identifier PXD001819 and can be used to benchmark other label-free workflows, adjust software parameter settings, improve algorithms for extraction of the quantitative metrics from raw MS data, or evaluate downstream statistical methods. Bioinformatic pipelines for label-free quantitative analysis must be objectively evaluated in their ability to detect variant proteins with good sensitivity and low false discovery rate in large-scale proteomic studies. This can be done through the use of complex spiked samples, for which the "ground truth" of variant proteins is known, allowing a statistical evaluation of the performances of the data processing workflow. We provide here such a controlled standard dataset and used it to evaluate the performances of several label-free bioinformatics tools (including MaxQuant, Skyline, MFPaQ, IRMa-hEIDI and Scaffold) in

  1. Using FTIR-ATR Spectroscopy to Teach the Internal Standard Method

    ERIC Educational Resources Information Center

    Bellamy, Michael K.

    2010-01-01

    The internal standard method is widely applied in quantitative analyses. However, most analytical chemistry textbooks either omit this topic or only provide examples of a single-point internal standardization. An experiment designed to teach students how to prepare an internal standard calibration curve is described. The experiment is a modified…

  2. 78 FR 18321 - International Code Council: The Update Process for the International Codes and Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... for Residential Construction in High Wind Regions. ICC 700: National Green Building Standard The..., coordinated, and necessary to regulate the built environment. Federal agencies frequently use these codes and... International Codes and Standards consist of the following: ICC Codes International Building Code. International...

  3. Assessment of the Impacts of Standards and Labeling Programs inMexico (four products).

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

    Sanchez, Itha; Pulido, Henry; McNeil, Michael A.

    2007-06-12

    This study analyzes impacts from energy efficiency standards and labeling in Mexico from 1994 through 2005 for four major products: household refrigerators, room air conditioners, three-phase (squirrel cage) induction motors, and clothes washers. It is a retrospective analysis, seeking to assess verified impacts on product efficiency in the Mexican market in the first ten years after standards were implemented. Such an analysis allows the Mexican government to compare actual to originally forecast program benefits. In addition, it provides an extremely valuable benchmark for other countries considering standards, and to the energy policy community as a whole. The methodology for evaluationmore » begins with historical test data taken for a large number of models of each product type between 1994 and 2005. The pre-standard efficiency of models in 1994 is taken as a baseline throughout the analysis. Model efficiency data were provided by an independent certification laboratory (ANCE), which tested products as part of the certification and enforcement mechanism defined by the standards program. Using this data, together with economic and market data provided by both government and private sector sources, the analysis considers several types of national level program impacts. These include: Energy savings; Environmental (emissions) impacts, and Net financial impacts to consumers, manufacturers and utilities. Energy savings impacts are calculated using the same methodology as the original projections, allowing a comparison. Other impacts are calculated using a robust and sophisticated methodology developed by the Instituto de Investigaciones Electricas (IIE) and Lawrence Berkeley National Laboratory (LBNL), in a collaboration supported by the Collaborative Labeling and Standards Program (CLASP).« less

  4. EPA STANDARDS NETWORK FACT SHEET: ISO 14000: INTERNATIONAL ENVIRONMENTAL MANAGEMENT STANDARDS

    EPA Science Inventory

    This flyer provides an overview of the ISO 14000 series of International standards, supplying a brief history, structure of the Technical Committee (TC) 207, structure of the U.S. Technical Advisory Group (TAG) to ISO TC-207, status of the Standards development as of June 1997, w...

  5. Direct synthesis of ESBO derivatives-¹⁸O labelled with dioxirane.

    PubMed

    La Tegola, Stefano; Annese, Cosimo; Suman, Michele; Tommasi, Immacolata; Fusco, Caterina; D'Accolti, Lucia

    2013-01-01

    This work addresses a new approach developed in our laboratory, consisting in the application of isolated dimethyldioxirane (DDO, 1a) labelled with ¹⁸O for synthesis of epoxidized glyceryl linoleate (Gly-LLL, 2). We expect that this work could contribute in improving analytical methods for the determination of epoxidized soybean oil (ESBO) in complex food matrices by adopting an ¹⁸O-labelled-epoxidized triacylglycerol as an internal standard.

  6. International Standard Payload Rack volume

    NASA Technical Reports Server (NTRS)

    2001-01-01

    Outer dimensions of the International Standard Payload Rack (ISPR) that will be used on the International Space Station (ISS) sets the envelope for scientists designing hardware for experiments in biological and physical sciences aboard ISS. The ISPR includes attachments to ISS utilities (electrical power, heating and cooling, data, fluids, vacuum, etc.) through standoffs that hold the racks in place in the lab modules. Usage will range from facilities that take entire racks to specialized drawers occupying a portion of a rack.

  7. Packaging and Labeling of Pharmaceutical Products Obtained from the Internet

    PubMed Central

    2011-01-01

    paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products’ packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Conclusions Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety. PMID:21324833

  8. Packaging and labeling of pharmaceutical products obtained from the internet.

    PubMed

    Veronin, Michael

    2011-02-15

    package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products' packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety.

  9. [Labeling of food containing genetically modified organisms: international policies and Brazilian legislation].

    PubMed

    Costa, Thadeu Estevam Moreira Maramaldo; Marin, Victor Augustus

    2011-08-01

    The increase in surface area planted with genetically modified crops, with the subsequent transfer of such crops into the general environment for commercial trade, has raised questions about the safety of these products. The introduction of the Cartagena Protocol on Biosafety has led to the need to produce information and ensure training in this area for the implementation of policies on biosafety and for decision-making on the part of governments at the national, regional and international level. This article presents two main standpoints regarding the labeling of GM products (one adopted by the United States and the other by the European Union), as well as the position adopted by Brazil and its current legislation on labeling and commercial release of genetically modified (GM) products.

  10. Operations and Plans: International Military Rationalization, Standardization, and Interoperability

    DTIC Science & Technology

    1989-02-15

    Army Regulation 34–1 Operations and Plans International Military Rationalization , Standardization, and Interoperability Headquarters Department of...YYYY) 15-02-1997 2. REPORT TYPE 3. DATES COVERED (FROM - TO) xx-xx-1997 to xx-xx-1997 4. TITLE AND SUBTITLE International Military Rationalization ...DSN 427-9007 Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std Z39.18 SUMMARY of CHANGE AR 34–1 International Military Rationalization

  11. International Standardization of Library and Documentation Techniques.

    ERIC Educational Resources Information Center

    International Federation for Documentation, The Hague (Netherlands).

    This comparative study of the national and international standards, rules and regulations on library and documentation techniques adopted in various countries was conducted as a preliminary step in determining the minimal bases for facilitating national and international cooperation between documentalists and librarians. The study compares and…

  12. Production of stable isotope-labeled acyl-coenzyme A thioesters by yeast stable isotope labeling by essential nutrients in cell culture

    PubMed Central

    Snyder, Nathaniel W.; Tombline, Gregory; Worth, Andrew J.; Parry, Robert C.; Silvers, Jacob A.; Gillespie, Kevin P.; Basu, Sankha S.; Millen, Jonathan; Goldfarb, David S.; Blair, Ian A.

    2015-01-01

    Acyl-coenzyme A (CoA) thioesters are key metabolites in numerous anabolic and catabolic pathways, including fatty acid biosynthesis and β-oxidation, the Krebs cycle, and cholesterol and isoprenoid biosynthesis. Stable isotope dilution-based methodology is the gold standard for quantitative analyses by mass spectrometry. However, chemical synthesis of families of stable isotope labeled metabolites such as acyl-coenzyme A thioesters is impractical. Previously, we biosynthetically generated a library of stable isotope internal standard analogs of acyl-CoA thioesters by exploiting the essential requirement in mammals and insects for pantothenic acid (vitamin B5) as a metabolic precursor for the CoA backbone. By replacing pantothenic acid in the cell media with commercially available [13C3 15N1]-pantothenic acid, mammalian cells exclusively incorporated [13C3 15N1]-pantothenate into the biosynthesis of acyl-CoA and acyl-CoA thioesters. We have now developed a much more efficient method for generating stable isotope labeled CoA and acyl-CoAs from [13C3 15N1]-pantothenate using Stable Isotope Labeling by Essential nutrients in Cell culture (SILEC) in Pan6 deficient yeast cells. Efficiency and consistency of labeling were also increased, likely due to the stringently defined and reproducible conditions used for yeast culture. The yeast SILEC method greatly enhances the ease of use and accessibility of labeled CoA thioesters and also provides proof-of-concept for generating other labeled metabolites in yeast mutants. PMID:25572876

  13. Replacement of the International Standard for Tetanus Antitoxin and the Use of the Standard in the Flocculation Test

    PubMed Central

    Spaun, J.; Lyng, J.

    1970-01-01

    Since 1935 the International Unit for Tetanus Antitoxin has been defined as the activity contained in a certain weight of the first International Standard for Tetanus Antitoxin. As stocks of this standard had become depleted, 11 laboratories in 8 countries were requested to participate in a collaborative assay of a preparation proposed as a replacement. The assay results were analysed and presented to the WHO Expert Committee on Biological Standardization in 1969 which established the preparation studied as the second International Standard for Tetanus Antitoxin and defined the International Unit for Tetanus Antitoxin as the activity contained in 0.03384 mg of the second International Standard for Tetanus Antitoxin. This definition would ensure the continuity of the size of this international unit. The analysis of the collaborative studies also showed that the second International Standard for Tetanus Antitoxin has suitable properties for use in the flocculation test for the determination of the antigen content of tetanus toxoids in Lf values. The designation Lf-equivalent is described and the problems relating to the use of this term for the expression of results of in vitro assays are analysed in relation to the use of international units for expressing results of in vivo assays. As the second International Standard for Tetanus Antitoxin has an in vivo/in vitro ratio of 1.4, the Lf-equivalent of this antitoxin is 1.4 times less than its unitage. PMID:5310949

  14. International documentary standards and comparison of national physical measurement standards for the calibration of accelerometers

    NASA Astrophysics Data System (ADS)

    Evans, David J.

    2002-11-01

    The documentary standards defining internationally adopted methodologies and protocols for calibrating transducers used to measure vibration are currently developed under the International Organization for Standardization (ISO) Technical Committee 108 Sub Committee 3 (Use and calibration of vibration and shock measuring instruments). Recent revisions of the documentary standards on primary methods for the calibration of accelerometers used to measure rectilinear motion have been completed. These standards can be, and have been, used as references in the technical protocols of key international and regional comparisons between National Measurement Institutes (NMIs) on the calibration of accelerometers. These key comparisons are occurring in part as a result of the creation of the Mutual Recognition Arrangement between NMIs which has appendices that document the uncertainties, and the comparisons completed in support of the uncertainties, claimed by the National Laboratories that are signatories of the MRA. The measurements for the first international and the first Interamerican System of Metrology (SIM) regional key comparisons in vibration have been completed. These intercomparisons were promulgated via the relatively new Consultative Committee for Acoustics, Ultrasound and Vibration (CCAUV) of the International Committee for Weights and Measures (CIPM) and SIM Metrology Working Group (MWG) 9, respectively.

  15. International Comparison of Product Certification and Verification Methods for Appliances

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

    Zhou, Nan; Romankiewicz, John; Fridley, David

    2012-06-01

    Enforcement of appliance standards and consumer trust in appliance labeling are important foundations of growing a more energy efficient economy. Product certification and verification increase compliance rates which in turn increase both energy savings and consumer trust. This paper will serve two purposes: 1) to review international practices for product certification and verification as they relate to the enforcement of standards and labeling programs in the U.S., E.U., Australia, Japan, Canada, and China; and 2) to make recommendations for China to implement improved certification processes related to their mandatory standards and labeling program such as to increase compliance rates andmore » energy savings potential.« less

  16. IPDA PDS4 Project: Towards an International Planetary Data Standard

    NASA Astrophysics Data System (ADS)

    Martinez, Santa; Roatsch, Thomas; Capria, Maria Teresa; Heather, David; Yamamoto, Yukio; Hughes, Steven; Stein, Thomas; Cecconi, Baptiste; Prashar, Ajay; Batanov, Oleg; Gopala Krishna, Barla

    2016-07-01

    The International Planetary Data Alliance (IPDA) is an international collaboration of space agencies with the main objective of facilitating discovery, access and use of planetary data managed across international boundaries. For this purpose, the IPDA has adopted the NASA's Planetary Data System (PDS) standard as the de-facto archiving standard, and is working towards the internationalisation of the new generation of the standards, called PDS4. PDS4 is the largest upgrade in the history of the PDS, and is a significant step towards an online, distributed, model-driven and service-oriented architecture international archive. Following the successful deployment of PDS4 to support NASA's LADEE and MAVEN missions, PDS4 was endorsed by IPDA in 2014. This has led to the adoption of PDS4 by a number of international space agencies (ESA, JAXA, ISRO and Roscosmos, among others) for their upcoming missions. In order to closely follow the development of the PDS4 standards and to coordinate the international contribution and participation in its evolution, a group of experts from each international agency is dedicated to review different aspects of the standards and to capture recommendations and requirements to ensure the international needs are met. The activities performed by this group cover the assessment and implementation of all aspects of PDS4, including its use, documentation, tools, validation strategies and information model. This contribution will present the activities carried out by this group and how this partnership between PDS and IPDA provides an excellent foundation towards an international platform for planetary science research.

  17. Inter-labeler and intra-labeler variability of condition severity classification models using active and passive learning methods.

    PubMed

    Nissim, Nir; Shahar, Yuval; Elovici, Yuval; Hripcsak, George; Moskovitch, Robert

    2017-09-01

    Labeling instances by domain experts for classification is often time consuming and expensive. To reduce such labeling efforts, we had proposed the application of active learning (AL) methods, introduced our CAESAR-ALE framework for classifying the severity of clinical conditions, and shown its significant reduction of labeling efforts. The use of any of three AL methods (one well known [SVM-Margin], and two that we introduced [Exploitation and Combination_XA]) significantly reduced (by 48% to 64%) condition labeling efforts, compared to standard passive (random instance-selection) SVM learning. Furthermore, our new AL methods achieved maximal accuracy using 12% fewer labeled cases than the SVM-Margin AL method. However, because labelers have varying levels of expertise, a major issue associated with learning methods, and AL methods in particular, is how to best to use the labeling provided by a committee of labelers. First, we wanted to know, based on the labelers' learning curves, whether using AL methods (versus standard passive learning methods) has an effect on the Intra-labeler variability (within the learning curve of each labeler) and inter-labeler variability (among the learning curves of different labelers). Then, we wanted to examine the effect of learning (either passively or actively) from the labels created by the majority consensus of a group of labelers. We used our CAESAR-ALE framework for classifying the severity of clinical conditions, the three AL methods and the passive learning method, as mentioned above, to induce the classifications models. We used a dataset of 516 clinical conditions and their severity labeling, represented by features aggregated from the medical records of 1.9 million patients treated at Columbia University Medical Center. We analyzed the variance of the classification performance within (intra-labeler), and especially among (inter-labeler) the classification models that were induced by using the labels provided by seven

  18. Brief International Cognitive Assessment for MS (BICAMS): international standards for validation.

    PubMed

    Benedict, Ralph H B; Amato, Maria Pia; Boringa, Jan; Brochet, Bruno; Foley, Fred; Fredrikson, Stan; Hamalainen, Paivi; Hartung, Hans; Krupp, Lauren; Penner, Iris; Reder, Anthony T; Langdon, Dawn

    2012-07-16

    An international expert consensus committee recently recommended a brief battery of tests for cognitive evaluation in multiple sclerosis. The Brief International Cognitive Assessment for MS (BICAMS) battery includes tests of mental processing speed and memory. Recognizing that resources for validation will vary internationally, the committee identified validation priorities, to facilitate international acceptance of BICAMS. Practical matters pertaining to implementation across different languages and countries were discussed. Five steps to achieve optimal psychometric validation were proposed. In Step 1, test stimuli should be standardized for the target culture or language under consideration. In Step 2, examiner instructions must be standardized and translated, including all information from manuals necessary for administration and interpretation. In Step 3, samples of at least 65 healthy persons should be studied for normalization, matched to patients on demographics such as age, gender and education. The objective of Step 4 is test-retest reliability, which can be investigated in a small sample of MS and/or healthy volunteers over 1-3 weeks. Finally, in Step 5, criterion validity should be established by comparing MS and healthy controls. At this time, preliminary studies are underway in a number of countries as we move forward with this international assessment tool for cognition in MS.

  19. Standards: The Keys to Domestic and International Competitiveness.

    ERIC Educational Resources Information Center

    Hunter, Robert D.

    1993-01-01

    Demonstrates the importance of standards for the competitiveness of U.S. companies and for international trade. The value of standards in research and development, marketing, design, purchasing, manufacturing, installation, and service is explained. Examples of specific standards and their application to the computer industry are included. (10…

  20. Inter-Labeler and Intra-Labeler Variability of Condition Severity Classification Models Using Active and Passive Learning Methods

    PubMed Central

    Nissim, Nir; Shahar, Yuval; Boland, Mary Regina; Tatonetti, Nicholas P; Elovici, Yuval; Hripcsak, George; Moskovitch, Robert

    2018-01-01

    Background and Objectives Labeling instances by domain experts for classification is often time consuming and expensive. To reduce such labeling efforts, we had proposed the application of active learning (AL) methods, introduced our CAESAR-ALE framework for classifying the severity of clinical conditions, and shown its significant reduction of labeling efforts. The use of any of three AL methods (one well known [SVM-Margin], and two that we introduced [Exploitation and Combination_XA]) significantly reduced (by 48% to 64%) condition labeling efforts, compared to standard passive (random instance-selection) SVM learning. Furthermore, our new AL methods achieved maximal accuracy using 12% fewer labeled cases than the SVM-Margin AL method. However, because labelers have varying levels of expertise, a major issue associated with learning methods, and AL methods in particular, is how to best to use the labeling provided by a committee of labelers. First, we wanted to know, based on the labelers’ learning curves, whether using AL methods (versus standard passive learning methods) has an effect on the Intra-labeler variability (within the learning curve of each labeler) and inter-labeler variability (among the learning curves of different labelers). Then, we wanted to examine the effect of learning (either passively or actively) from the labels created by the majority consensus of a group of labelers. Methods We used our CAESAR-ALE framework for classifying the severity of clinical conditions, the three AL methods and the passive learning method, as mentioned above, to induce the classifications models. We used a dataset of 516 clinical conditions and their severity labeling, represented by features aggregated from the medical records of 1.9 million patients treated at Columbia University Medical Center. We analyzed the variance of the classification performance within (intra-labeler), and especially among (inter-labeler) the classification models that were induced by

  1. Features of standardized nursing terminology sets in Japan.

    PubMed

    Sagara, Kaoru; Abe, Akinori; Ozaku, Hiromi Itoh; Kuwahara, Noriaki; Kogure, Kiyoshi

    2006-01-01

    This paper reports the features and relationships between standardizes nursing terminology sets used in Japan. First, we analyzed the common parts in five standardized nursing terminology sets: the Japan Nursing Practice Standard Master (JNPSM) that includes the names of nursing activities and is built by the Medical Information Center Development Center (MEDIS-DC); the labels of the Japan Classification of Nursing Practice (JCNP), built by the term advisory committee in the Japan Academy of Nursing Science; the labels of the International Classification for Nursing Practice (ICNP) translated to Japanese; the labels, domain names, and class names of the North American Nursing Diagnosis Association (NANDA) Nursing Diagnoses 2003-2004 translated to Japanese; and the terms included in the labels of Nursing Interventions Classification (NIC) translated to Japanese. Then we compared them with terms in a thesaurus dictionary, the Bunrui Goihyo, that contains general Japanese words and is built by the National Institute for Japanese Language. 1) the level of interchangeability between four standardized nursing terminology sets is quite low; 2) abbreviations and katakana words are frequently used to express nursing activities; 3) general Japanese words are usually used to express the status or situation of patients.

  2. Nutrition labelling: purpose, scientific issues and challenges.

    PubMed

    Van den Wijngaart, Annoek W E M

    2002-01-01

    Nutrition labels describe the nutrient content of a food and are intended to guide the consumer in food selection. The nutrition information provided must be selected on the basis of consistency with dietary recommendations. Selection of the specific nutrients or food components to be listed should further take into account label space, the analytical feasibility of measuring the particular nutritional component within the food matrix, and the relative costs of such analyses. Nutrition information provided on labels should be truthful and not mislead consumers. At the same time, labelling regulations should provide incentives to manufacturers to develop products that promote public health and assist consumers in following dietary recommendations. It is likely that in many countries, there would be some segments of the population that would benefit from information about the composition of foods. In these cases, countries should consider the need to provide for appropriate labelling and its presentation relative to existing guidelines and approaches. As nutrition-labelling efforts have evolved, different approaches and legal requirements have been established. These create difficulties in developing and harmonizing nutrition information listings, which have broad international applications. For these reasons, the Codex Guidelines on Nutrition Labeling play an important role to provide guidance to member countries when they want to develop or update their national regulations and to encourage harmonization of national standards with international standards. These Guidelines are based on the principle that no food should be described or presented in a manner that is false, misleading or deceptive. The Guidelines include provisions for voluntary nutrient declaration, calculation and presentation of nutrient information. The Guidelines on Claims establish general principles to be followed and leave the definition of specific claims to national regulations. Definitions

  3. The Impact of Standard Nutrition Labels on Alcoholic Beverages

    ERIC Educational Resources Information Center

    Martinez, Julia A.; Dale, Chelsea F.; Fontana, Victoria C.; Collier, Suzanne L.

    2015-01-01

    Whether or not to mandate nutrition labels on alcoholic beverages is a topic of debate. We examined the effect of nutrition labels on (1) plans for drinking and (2) alcohol expectancies. Study 1, n = 80 underage college drinkers responded to an image of a beer with or without a nutrition label. Study 2, n = 98 community drinkers responded to…

  4. Interrogating Identity: The International Standard School in Indonesia

    ERIC Educational Resources Information Center

    Sakhiyya, Zulfa

    2011-01-01

    This paper examines the impact of the International Standard School (ISS) on the identity of Indonesia as a postcolonial nation. According to the Indonesian Ministry of National Education, an ISS is "a school which complies with the National Standard of Education and enriches its standards from the Organisation for Economic Cooperation and…

  5. CTEPP STANDARD OPERATING PROCEDURE FOR PREPARATION OF SURROGATE RECOVERY STANDARD AND INTERNAL STANDARD SOLUTIONS FOR NEUTRAL TARGET ANALYTES (SOP-5.25)

    EPA Science Inventory

    This standard operating procedure describes the method used for preparing internal standard, surrogate recovery standard and calibration standard solutions for neutral analytes used for gas chromatography/mass spectrometry analysis.

  6. Issues concerning international comparison of free-field calibrations of acoustical standards

    NASA Astrophysics Data System (ADS)

    Nedzelnitsky, Victor

    2002-11-01

    Primary free-field calibrations of laboratory standard microphones by the reciprocity method establish these microphones as reference standard devices for calibrating working standard microphones, other measuring microphones, and practical instruments such as sound level meters and personal sound exposure meters (noise dosimeters). These primary, secondary, and other calibrations are indispensable to the support of regulatory requirements, standards, and product characterization and quality control procedures important for industry, commerce, health, and safety. International Electrotechnical Commission (IEC) Technical Committee 29 Electroacoustics produces international documentary standards, including standards for primary and secondary free-field calibration and measurement procedures and their critically important application to practical instruments. This paper addresses some issues concerning calibrations, standards activities, and the international key comparison of primary free-field calibrations of IEC-type LS2 laboratory standard microphones that is being planned by the Consultative Committee for Acoustics, Ultrasound, and Vibration (CCAUV) of the International Committee for Weights and Measures (CIPM). This comparison will include free-field calibrations by the reciprocity method at participating major national metrology laboratories throughout the world.

  7. 25 CFR 542.32 - What are the minimum internal control standards for internal audit for Tier B gaming operations?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 2 2013-04-01 2013-04-01 false What are the minimum internal control standards for internal audit for Tier B gaming operations? 542.32 Section 542.32 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.32 What are the minimum internal control standards for...

  8. 25 CFR 542.22 - What are the minimum internal control standards for internal audit for Tier A gaming operations?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 2 2012-04-01 2012-04-01 false What are the minimum internal control standards for internal audit for Tier A gaming operations? 542.22 Section 542.22 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.22 What are the minimum internal control standards for...

  9. 25 CFR 542.22 - What are the minimum internal control standards for internal audit for Tier A gaming operations?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 2 2013-04-01 2013-04-01 false What are the minimum internal control standards for internal audit for Tier A gaming operations? 542.22 Section 542.22 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.22 What are the minimum internal control standards for...

  10. 25 CFR 542.22 - What are the minimum internal control standards for internal audit for Tier A gaming operations?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for internal audit for Tier A gaming operations? 542.22 Section 542.22 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.22 What are the minimum internal control standards for...

  11. 25 CFR 542.22 - What are the minimum internal control standards for internal audit for Tier A gaming operations?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 2 2011-04-01 2011-04-01 false What are the minimum internal control standards for internal audit for Tier A gaming operations? 542.22 Section 542.22 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.22 What are the minimum internal control standards for...

  12. 25 CFR 542.32 - What are the minimum internal control standards for internal audit for Tier B gaming operations?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 2 2011-04-01 2011-04-01 false What are the minimum internal control standards for internal audit for Tier B gaming operations? 542.32 Section 542.32 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.32 What are the minimum internal control standards for...

  13. 25 CFR 542.32 - What are the minimum internal control standards for internal audit for Tier B gaming operations?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 2 2012-04-01 2012-04-01 false What are the minimum internal control standards for internal audit for Tier B gaming operations? 542.32 Section 542.32 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.32 What are the minimum internal control standards for...

  14. 25 CFR 542.32 - What are the minimum internal control standards for internal audit for Tier B gaming operations?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for internal audit for Tier B gaming operations? 542.32 Section 542.32 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.32 What are the minimum internal control standards for...

  15. The international development of forensic science standards - A review.

    PubMed

    Wilson-Wilde, Linzi

    2018-04-16

    Standards establish specifications and procedures designed to ensure products, services and systems are safe, reliable and consistently perform as intended. Standards can be used in the accreditation of forensic laboratories or facilities and in the certification of products and services. In recent years there have been various international activities aiming at developing forensic science standards and guidelines. The most significant initiative currently underway within the global forensic community is the development of International Organization for Standardization (ISO) standards. This paper reviews the main bodies working on standards for forensic science, the processes used and the implications for accreditation. This paper specifically discusses the work of ISO Technical Committee TC272, the future TC272 work program for the development of forensic science standards and associated timelines. Also discussed, are the lessons learnt to date in navigating the complex environment of multi-country stakeholder deliberations in standards development. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.

  16. Radiation safety standards and their application: international policies and current issues.

    PubMed

    González, Abel J

    2004-09-01

    This paper briefly describes the current policies of the United Nations Scientific Committee on the Effects of Atomic Radiation and the International Commission on Radiological Protection and how these policies are converted into international radiation safety standards by the International Atomic Energy Agency, which is the only global organization-within the United Nations family of international agencies-with a statutory mandate not only to establish such standards but also to provide for their application. It also summarizes the current status of the established corpus of such international standards, and of it foreseeable evolution, as well as of legally binding undertakings by countries around the world that are linked to these standards. Moreover, this paper also reviews some major current global issues related to the application of international standards, including the following: strengthening of national infrastructures for radiation safety, including technical cooperation programs for assisting developing countries; occupational radiation safety challenges, including the protection of pregnant workers and their unborn children, dealing with working environments with high natural radiation levels, and occupational attributability of health effects (probability of occupational causation); restricting discharges of radioactive substances into the environment: reviewing current international policies vis-a-vis the growing concern on the radiation protection of the "environment;" radiological protection of patients undergoing radiodiagnostic and radiotherapeutic procedures: the current International Action Plan; safety and security of radiation sources: post-11 September developments; preparedness and response to radiation emergencies: enhancing the international network; safe transport of radioactive materials: new apprehensions; safety of radioactive waste management: concerns and connections with radiation protection; and radioactive residues remaining

  17. Advancements in internationally accepted standards for radiation processing

    NASA Astrophysics Data System (ADS)

    Farrar, Harry; Derr, Donald D.; Vehar, David W.

    1993-10-01

    Three subcommittees of the American Society for Testing and Materials (ASTM) are developing standards on various aspects of radiation processing. Subcommittee E10.01 "Dosimetry for Radiation Processing" has published 9 standards on how to select and calibrate dosimeters, where to put them, how many to use, and how to use individual types of dosimeter systems. The group is also developing standards on how to use gamma, electron beam, and x-ray facilities for radiation processing, and a standard on how to treat dose uncertainties. Efforts are underway to promote inclusion of these standards into procedures now being developed by government agencies and by international groups such as the United Nations' International Consultative Group on Food Irradiation (ICGFI) in order to harmonize regulations and help avoid trade barriers. Subcommittee F10.10 "Food Processing and Packaging" has completed standards on good irradiation practices for meat and poultry and for fresh fruits, and is developing similar standards for the irradiation of seafood and spices. These food-related standards are based on practices previously published by ICGFI. Subcommittee E10.07 on "Radiation Dosimetry for Radiation Effects on Materials and Devices" principally develops standards for determining doses for radiation hardness testing of electronics. Some, including their standards on the Fricke and TLD dosimetry systems are equally useful in other radiation processing applications.

  18. Best-Matched Internal Standard Normalization in Liquid Chromatography-Mass Spectrometry Metabolomics Applied to Environmental Samples.

    PubMed

    Boysen, Angela K; Heal, Katherine R; Carlson, Laura T; Ingalls, Anitra E

    2018-01-16

    The goal of metabolomics is to measure the entire range of small organic molecules in biological samples. In liquid chromatography-mass spectrometry-based metabolomics, formidable analytical challenges remain in removing the nonbiological factors that affect chromatographic peak areas. These factors include sample matrix-induced ion suppression, chromatographic quality, and analytical drift. The combination of these factors is referred to as obscuring variation. Some metabolomics samples can exhibit intense obscuring variation due to matrix-induced ion suppression, rendering large amounts of data unreliable and difficult to interpret. Existing normalization techniques have limited applicability to these sample types. Here we present a data normalization method to minimize the effects of obscuring variation. We normalize peak areas using a batch-specific normalization process, which matches measured metabolites with isotope-labeled internal standards that behave similarly during the analysis. This method, called best-matched internal standard (B-MIS) normalization, can be applied to targeted or untargeted metabolomics data sets and yields relative concentrations. We evaluate and demonstrate the utility of B-MIS normalization using marine environmental samples and laboratory grown cultures of phytoplankton. In untargeted analyses, B-MIS normalization allowed for inclusion of mass features in downstream analyses that would have been considered unreliable without normalization due to obscuring variation. B-MIS normalization for targeted or untargeted metabolomics is freely available at https://github.com/IngallsLabUW/B-MIS-normalization .

  19. 46 CFR 199.03 - Relationship to international standards.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 7 2011-10-01 2011-10-01 false Relationship to international standards. 199.03 Section 199.03 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) LIFESAVING APPLIANCES AND ARRANGEMENTS LIFESAVING SYSTEMS FOR CERTAIN INSPECTED VESSELS General § 199.03 Relationship to international...

  20. A review of the International Atomic Energy Agency (IAEA) international standards for tissue banks.

    PubMed

    Morales Pedraza, Jorge; Lobo Gajiwala, Astrid; Martinez Pardo, María Esther

    2012-03-01

    The IAEA International Standards for Tissue Banks published in 2003 were based on the Standards then currently in use in the USA and the European Union, among others, and reflect the best practices associated with the operation of a tissue bank. They cover legal, ethical and regulatory controls as well as requirements and procedures from donor selection and tissue retrieval to processing and distribution of finished tissue for clinical use. The application of these standards allows tissue banks to operate with the current good tissue practice, thereby providing grafts of high quality that satisfy the national and international demand for safe and biologically useful grafts. The objective of this article is to review the IAEA Standards and recommend new topics that could improve the current version.

  1. Effect of standards on new equipment design by new international standards and industry restraints

    NASA Astrophysics Data System (ADS)

    Endelman, Lincoln L.

    1991-01-01

    The use of international standards to further trade is one of the objectives of creating a standard. By having form fit and function compatible the free interchange of manufactured goods can be handled without hindrance. Unfortunately by setting up standards that are peculiar to a particular country or district it is possible to exclude competition from a group of manufacturers. A major effort is now underway to develop international laser standards. In the May I 990 issue of Laser Focus World Donald R. Johnson the director of industrial technology services for the National Institute of Standards and Technology (NIST formerly the National Bureau of Standards) is quoted as follows: " The common means of protectionism has been through certification for the market place. " The article goes on to say " Mr. Johnson expects this tradition to continue and that the new European Community (EC) will demand not just safety standards but performance standards as well. . . . the American laser industry must move very quickly on this issue or risk being left behind the European standards bandwagon. " The article continues laser companies must get involved in the actual standards negotiating process if they are to have a say in future policy. A single set of standards would reduce the need to repeatedly recalibrate products for different national markets. " As a member of ISO TC-72 SC9 I am

  2. International Safety Regulation and Standards for Space Travel and Commerce

    NASA Astrophysics Data System (ADS)

    Pelton, J. N.; Jakhu, R.

    The evolution of air travel has led to the adoption of the 1944 Chicago Convention that created the International Civil Aviation Organization (ICAO), headquartered in Montreal, Canada, and the propagation of aviation safety standards. Today, ICAO standardizes and harmonizes commercial air safety worldwide. Space travel and space safety are still at an early stage of development, and the adoption of international space safety standards and regulation still remains largely at the national level. This paper explores the international treaties and conventions that govern space travel, applications and exploration today and analyzes current efforts to create space safety standards and regulations at the national, regional and global level. Recent efforts to create a commercial space travel industry and to license commercial space ports are foreseen as means to hasten a space safety regulatory process.

  3. Enhanced sensitivity and multiplexing with 2D LC/MRM-MS and labeled standards for deeper and more comprehensive protein quantitation.

    PubMed

    Percy, Andrew J; Simon, Romain; Chambers, Andrew G; Borchers, Christoph H

    2014-06-25

    Mass spectrometry (MS)-based protein quantitation is increasingly being employed to verify candidate protein biomarkers. Multiple or selected reaction monitoring-mass spectrometry (MRM-MS or SRM-MS) with isotopically labeled internal standards has proven to be a successful approach in that regard, but has yet to reach its full potential in terms of multiplexing and sensitivity. Here, we report the development of a new MRM method for the quantitation of 253 disease-associated proteins (represented by 625 interference-free peptides) in 13 LC fractions. This 2D RPLC/MRM-MS approach extends the depth and breadth of the assay by 2 orders of magnitude over pre-fractionation-free assays, with 31 proteins below 10 ng/mL and 41 proteins above 10 ng/mL now quantifiable. Standard flow rates are used in both chromatographic dimensions, and up-front depletion or antibody-based enrichment is not required. The LC separations utilize high and low pH conditions, with the former employing an ammonium hydroxide-based eluent, instead of the conventional ammonium formate, resulting in improved LC column lifetime and performance. The high sensitivity (determined concentration range: 15 mg/mL to 452 pg/mL) and robustness afforded by this method makes the full MRM panel, or subsets thereof, useful for the verification of disease-associated plasma protein biomarkers in patient samples. The described research extends the breadth and depth of protein quantitation in undepleted and non-enriched human plasma by employing standard-flow 2D RPLC/MRM-MS in conjunction with a complex mixture of isotopically labeled peptide standards. The proteins quantified are mainly putative biomarkers of non-communicable (i.e., non-infectious) disease (e.g., cardiovascular or cancer), which require pre-clinical verification and validation before clinical implementation. Based on the enhanced sensitivity and multiplexing, this quantitative plasma proteomic method should prove useful in future candidate biomarker

  4. A label distance maximum-based classifier for multi-label learning.

    PubMed

    Liu, Xiaoli; Bao, Hang; Zhao, Dazhe; Cao, Peng

    2015-01-01

    Multi-label classification is useful in many bioinformatics tasks such as gene function prediction and protein site localization. This paper presents an improved neural network algorithm, Max Label Distance Back Propagation Algorithm for Multi-Label Classification. The method was formulated by modifying the total error function of the standard BP by adding a penalty term, which was realized by maximizing the distance between the positive and negative labels. Extensive experiments were conducted to compare this method against state-of-the-art multi-label methods on three popular bioinformatic benchmark datasets. The results illustrated that this proposed method is more effective for bioinformatic multi-label classification compared to commonly used techniques.

  5. Target analyte quantification by isotope dilution LC-MS/MS directly referring to internal standard concentrations--validation for serum cortisol measurement.

    PubMed

    Maier, Barbara; Vogeser, Michael

    2013-04-01

    Isotope dilution LC-MS/MS methods used in the clinical laboratory typically involve multi-point external calibration in each analytical series. Our aim was to test the hypothesis that determination of target analyte concentrations directly derived from the relation of the target analyte peak area to the peak area of a corresponding stable isotope labelled internal standard compound [direct isotope dilution analysis (DIDA)] may be not inferior to conventional external calibration with respect to accuracy and reproducibility. Quality control samples and human serum pools were analysed in a comparative validation protocol for cortisol as an exemplary analyte by LC-MS/MS. Accuracy and reproducibility were compared between quantification either involving a six-point external calibration function, or a result calculation merely based on peak area ratios of unlabelled and labelled analyte. Both quantification approaches resulted in similar accuracy and reproducibility. For specified analytes, reliable analyte quantification directly derived from the ratio of peak areas of labelled and unlabelled analyte without the need for a time consuming multi-point calibration series is possible. This DIDA approach is of considerable practical importance for the application of LC-MS/MS in the clinical laboratory where short turnaround times often have high priority.

  6. Microwave-assisted deuterium exchange: the convenient preparation of isotopically labelled analogues for stable isotope dilution analysis of volatile wine phenols.

    PubMed

    Crump, Anna M; Sefton, Mark A; Wilkinson, Kerry L

    2014-11-01

    This study reports the convenient, low cost, one-step synthesis of labelled analogues of six volatile phenols, guaiacol, 4-methylguaiacol, 4-ethylguaiacol, 4-ethylphenol, eugenol and vanillin, using microwave-assisted deuterium exchange, for use as internal standards for stable isotope dilution analysis. The current method improves on previous strategies in that it enables incorporation of deuterium atoms on the aromatic ring, thereby ensuring retention of the isotope label during mass spectrometry fragmentation. When used as standards for SIDA, these labelled volatile phenols will improve the accuracy and reproducibility of quantitative food and beverage analysis. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Fifth International Standard for Gas-Gangrene Antitoxin (Perfringens) (Clostridium welchii Type A Antitoxin)

    PubMed Central

    Evans, D. G.; Perkins, F. T.

    1963-01-01

    The Fifth International Standard Gas-Gangrene Antitoxin (Perfringens) (Clostridium welchii Type A Antitoxin) was prepared from serum from immunized horses. It was freeze-dried in ampoules each containing 1 ml. Seven laboratories collaborated in assaying its potency in terms of the Fourth International Standard by the intravenous inoculation of mice. The geometric mean value, taking the results of all the laboratories, was 270 International Units per ampoule and the maximum variation between laboratories was 15%. In vitro (lecithinase) tests were also done by three laboratories, giving an average of 261 International Units per ampoule. The dry weight contents of ampoules, determined in three laboratories, varied by less than 3%, with an average of 90.35 mg per ampoule. The standard was stable for 120 hours at 56°C. Each ampoule of the Fifth International Standard for Gas-Gangrene Antitoxin (Perfringens) contains 270 International Units, and one International Unit is contained in 0.3346 mg of the International Standard. PMID:14107745

  8. Different contributions of internal reviewers and external experts to labelling decisions on therapeutic indications in new drug reviews in Japan.

    PubMed

    Yokota, M; Kusama, M; Matsuki, N; Ono, S

    2013-12-01

    External experts play an important role in shaping regulatory decisions in the new drug review process in the United States, Europe and Japan. No rigorous study has been performed addressing how and to what extent external experts, in contrast to internal reviewers in the agency, influence the regulatory decisions during new drug reviews. We examined their contributions in Japanese regulatory reviews in contrast to the internal reviewers, focusing on the labelling decision on therapeutic indications. With the data set of 219 new molecular entities (NMEs) approved in Japan from 2000 to 2009, we observed how proposed indications in labelling were modified in a stepwise manner during the review process and conducted multinomial logistic analysis to examine the possible mechanism behind. We found that interim assessment of indications by the internal reviewers was modified substantially by the influence of the external experts in about 20% of the 219 NMEs. Our analysis suggested that internal reviewers provided their opinion mainly based on strict review discipline, whereas external experts added flexibility and reality to their reviews. Our analysis revealed different evaluations between internal reviewers and external experts during regulatory discussions in new drug reviews and how the external panel contributes to changing internal decisions. This study provides a new and quantitative approach to better label setting by emphasizing the contributions of each stakeholder in new drug reviews, which would improve the efficiency, quality and transparency of new drug reviews to enhance public health. © 2013 John Wiley & Sons Ltd.

  9. 40 CFR 262.206 - Labeling and management standards for containers of unwanted material in the laboratory.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 25 2010-07-01 2010-07-01 false Labeling and management standards for containers of unwanted material in the laboratory. 262.206 Section 262.206 Protection of Environment... the laboratory to assure safe storage of the unwanted material, to prevent leaks, spills, emissions to...

  10. The CMMI Product Suite and International Standards

    DTIC Science & Technology

    2006-07-01

    standards: “2.3 Reference Documents 2.3.1 Applicable ISO /IEC documents, including ISO /IEC 12207 and ISO /IEC 15504.” “3.1 Development User Requirements...related international standards such as ISO 9001:2000, 12207 , 15288 © 2006 by Carnegie Mellon University Page 12 Key Supplements Needed...the Measurement Framework in ISO /IEC 15504; and • the Process Reference Model included in ISO /IEC 12207 . A possible approach has been developed for

  11. Compliance status of product labels to the international code on marketing of breast milk substitutes.

    PubMed

    Ergin, Ahmet; Hatipoğlu, Celile; Bozkurt, Ali Ihsan; Erdoğan, Aslı; Güler, Serdar; Ince, Gülberat; Kavurgacı, Nuran; Oz, Ahmet; Yeniay, Mustafa K

    2013-01-01

    The aim of this study was to determine the compliance status of product labels regarding Article 9 of the International Code on Marketing of Breast-milk Substitutes (the Code) in Denizli province, Turkey. A cross-sectional study design was employed to determine the compliance status. The product labels were obtained from a convenience sample of five supermarkets, one store and 5 pharmacies in the City centre and district of Honaz. Using a data collection form prepared by previously published studies, data were collected between July 26, 2010 and August 06, 2010. Data collection form included 13 criteria. In addition, we checked the boxes for the availability of a Turkish written label. Forty product labels of 7 companies were reached and evaluated. These products consisted of 83.0% of the products marketed by these companies in Turkey. Thirty seven (92.5%) of the labels violated Article 9 of the Code in terms of one or more criteria. Thirty four (85.0%) of the labels had photos or pictures idealizing the use of infant formula. Nine (22.5%) had a photo, a picture or any representation of an infant, and five (12.5%) had text which idealize the use of infant formula or discouraging breastfeeding. Eight (20%) did not state that breastfeeding is the best. Four (10%) had a term such as 'similar to breast milk or human milk'. In conclusion, the majority of the product labels of breast milk substitutes marketed in our country violate the Code. It is appropriate that the Turkish Ministry of Health, medical organizations, companies, and NGOs work more actively to increase awareness of this issue.

  12. Multilevel Linkages between State Standards, Teacher Standards, and Student Achievement: Testing External versus Internal Standards-Based Education Models

    ERIC Educational Resources Information Center

    Lee, Jaekyung; Liu, Xiaoyan; Amo, Laura Casey; Wang, Weichun Leilani

    2014-01-01

    Drawing on national and state assessment datasets in reading and math, this study tested "external" versus "internal" standards-based education models. The goal was to understand whether and how student performance standards work in multilayered school systems under No Child Left Behind Act of 2001 (NCLB). Under the…

  13. [Differences and international standardization between acupuncture as therapy and as specialty].

    PubMed

    Ng, Szetuen

    2017-01-12

    The purpose of this study is to explore the differences of definition and clinical roles as well as international standardization between acupuncture as therapy and as specialty, which can provide reference evidence for specialization and internationalization of acupuncture. Owing to the clinical efficacy and safety, the credibility and controversy both exist in acupuncture; moreover, there is a lack of fair definition and international precedent regarding acupuncture specialty. Therefore, it is particularly essential to objectively compare the differences of definitions and clinical roles as well as criteria of international standardization for acupuncture as therapy and as specialty. It is believed acupuncture standardization can draw lessons from the international medical standards, evidence-based medicine and acupuncture theory from the following three major projects:acupuncture safety and contraindications; acupuncture indications and treatment guidelines; acupuncture indication classified into 3 levels of evidence-based acupuncture disease spectrum, as objective evidence of indication of acupuncture specialty.

  14. International standards for brucellosis prevention and management.

    PubMed

    Ragan, V; Vroegindewey, G; Babcock, S

    2013-04-01

    International standards are a crucial element in brucellosis prevention and management. They allow policy-makers, scientists, epidemiologists, laboratories and trade entities to have a common vocabulary for communication and understanding of the disease. These standards cover the entire spectrum of activities from surveillance, testing, prophylaxis, transport and trade to policy development, research and reporting. Developing, adhering to and monitoring standards increases both the effectiveness and efficiency of prevention and management programmes. Creating standards with the input of all stakeholders ensures that the standards do not adversely affect the requirements of any of the multiple parties involved. The World Organisation for Animal Health (OIE), in conjunction with its Member Countries, and through its standing and ad hoc committees plus expert input, has taken a key leadership role in developing and reviewing brucellosis standards. These standards are used to harmonise testing, prevention processes, vaccines and reporting, to support trade and to protect human and animal health.

  15. 77 FR 60625 - Minimum Internal Control Standards for Class II Gaming

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-04

    ...-37 Minimum Internal Control Standards for Class II Gaming AGENCY: National Indian Gaming Commission... Internal Control Standards that were published on September 21, 2012. DATES: The effective date [email protected] . FOR FURTHER INFORMATION CONTACT: Jennifer Ward, Attorney, NIGC Office of General Counsel, at...

  16. Reading the Small Print – Labelling Recommendations for Orthopaedic Implants

    PubMed Central

    Haene, Roger A; Sandhu, Ranbir S; Baxandall, Richard

    2009-01-01

    INTRODUCTION There exist, currently, no clear guidelines regarding standards for surgical implant labelling. Dimensions of the laminar flow canopies in orthopaedic use fixes the distance at which implant labels can be read. Mistakes when reading the label on an implant box can pose health risks for patients, and financial consequences for medical institutions. SUBJECTS AND METHODS Using scientifically validated tools such as the Snellen Chart Formula, a theoretical minimum standard for text on implant labels was reached. This theoretical standard was then tested under real operating conditions. After discovering a minimum practical standard for implant labels, the authors then audited current labels in use on a wide range of orthopaedic implant packages. Furthermore, other non-text-related labelling problems were also noted. RESULTS There is a definite minimum standard which should be observed when implant labels are manufactured. Implants in current use bear labels on the packaging that are of an insufficient standard to ensure patient safety in theatre. CONCLUSIONS The authors have established text parameters that will increase the legibility of implant labels. In the interests of improving risk management in theatre, therefore, the authors propose a standard for orthopaedic implant labelling, and believe this will provide a useful foundation for further discussion between the orthopaedic community and implant manufacturers. PMID:19686615

  17. Ra-224 labeling of calcium carbonate microparticles for internal α-therapy: Preparation, stability, and biodistribution in mice.

    PubMed

    Westrøm, Sara; Malenge, Marion; Jorstad, Ida Sofie; Napoli, Elisa; Bruland, Øyvind S; Bønsdorff, Tina B; Larsen, Roy H

    2018-05-30

    Internal therapy with α-emitters should be well suited for micrometastatic disease. Radium-224 emits multiple α-particles through its decay and has a convenient 3.6 days of half-life. Despite its attractive properties, the use of 224 Ra has been limited to bone-seeking applications because it cannot be stably bound to a targeting molecule. Alternative delivery systems for 224 Ra are therefore of considerable interest. In this study, calcium carbonate microparticles are proposed as carriers for 224 Ra, designed for local therapy of disseminated cancers in cavitary regions, such as peritoneal carcinomatosis. Calcium carbonate microparticles were radiolabeled by precipitation of 224 Ra on the particle surface, resulting in high labeling efficiencies for both 224 Ra and daughter 212 Pb and retention of more than 95% of these nuclides for up to 1 week in vitro. The biodistribution after intraperitoneal administration of the 224 Ra-labeled CaCO 3 microparticles in immunodeficient mice revealed that the radioactivity mainly remained in the peritoneal cavity. In addition, the systemic distribution of 224 Ra was found to be strongly dependent on the amount of administered microparticles, with a reduced skeletal uptake of 224 Ra with increasing dose. The results altogether suggest that the 224 Ra-labeled CaCO 3 microparticles have promising properties for use as a localized internal α-therapy of cavitary cancers. © 2018 Oncoinvent AS. Journal of Labelled Compounds and Radiopharmaceuticals Published by John Wiley & Sons, Ltd.

  18. CTEPP STANDARD OPERATING PROCEDURE FOR PREPARATION OF SURROGATE RECOVERY STANDARD AND INTERNAL STANDARD SOLUTIONS FOR POLAR TARGET ANALYTES (SOP-5.26)

    EPA Science Inventory

    This SOP describes the method used for preparing surrogate recovery standard and internal standard solutions for the analysis of polar target analytes. It also describes the method for preparing calibration standard solutions for polar analytes used for gas chromatography/mass sp...

  19. Food labeling; nutrition labeling of standard menu items in restaurants and similar retail food establishments. Final rule.

    PubMed

    2014-12-01

    To implement the nutrition labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act or ACA), the Food and Drug Administration (FDA or we) is requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The ACA, in part, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), among other things, to require restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under provisions of the ACA, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to these Federal requirements by registering every other year with FDA. Providing accurate, clear, and consistent nutrition information, including the calorie content of foods, in restaurants and similar retail food establishments will make such nutrition information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.

  20. 78 FR 951 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1205] Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments...

  1. International standards for pandemic screening using infrared thermography

    NASA Astrophysics Data System (ADS)

    Pascoe, D. D.; Ring, E. F.; Mercer, J. B.; Snell, J.; Osborn, D.; Hedley-Whyte, J.

    2010-03-01

    The threat of a virulent strain of influenza, severe acute respiratory syndrome (SARS), tuberculosis, H1N1/A virus (swine flu) and possible mutations are a constant threat to global health. Implementation of pandemic infrared thermographic screening is based on the detection of febrile temperatures (inner canthus of the eyes) that are correlated with an infectious disease. Previous attempts at pandemic thermal screening have experienced problems (e.g. SARS outbreak, Singapore 2003) associated with the deployment plan, implementation and operation of the screening thermograph. Since this outbreak, the International Electrotechnical Commission has developed international standards that set minimum requirements for thermographic system fever screening and procedures that insure reliable and reproducible measurements. These requirements are published in IEC 80601-2-59:2008, Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening. The International Organization for Standardization has developed ISO/TR 13154:2009, Medical Electrical Equipment - which provides deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph. These new standards includes recommendations for camera calibrations, use of black body radiators, view field, focus, pixels within measurement site, image positioning, and deployment locations. Many current uses of thermographic screening at airports do not take into account critical issues addressed in the new standard, and are operating below the necessary effectiveness and efficiency. These documents, related thermal research, implications for epidemiology screening, and the future impact on medical thermography are discussed.

  2. International collaborative study for the calibration of proposed International Standards for thromboplastin, rabbit, plain, and for thromboplastin, recombinant, human, plain.

    PubMed

    van den Besselaar, A M H P; Chantarangkul, V; Angeloni, F; Binder, N B; Byrne, M; Dauer, R; Gudmundsdottir, B R; Jespersen, J; Kitchen, S; Legnani, C; Lindahl, T L; Manning, R A; Martinuzzo, M; Panes, O; Pengo, V; Riddell, A; Subramanian, S; Szederjesi, A; Tantanate, C; Herbel, P; Tripodi, A

    2018-01-01

    Essentials Two candidate International Standards for thromboplastin (coded RBT/16 and rTF/16) are proposed. International Sensitivity Index (ISI) of proposed standards was assessed in a 20-centre study. The mean ISI for RBT/16 was 1.21 with a between-centre coefficient of variation of 4.6%. The mean ISI for rTF/16 was 1.11 with a between-centre coefficient of variation of 5.7%. Background The availability of International Standards for thromboplastin is essential for the calibration of routine reagents and hence the calculation of the International Normalized Ratio (INR). Stocks of the current Fourth International Standards are running low. Candidate replacement materials have been prepared. This article describes the calibration of the proposed Fifth International Standards for thromboplastin, rabbit, plain (coded RBT/16) and for thromboplastin, recombinant, human, plain (coded rTF/16). Methods An international collaborative study was carried out for the assignment of International Sensitivity Indexes (ISIs) to the candidate materials, according to the World Health Organization (WHO) guidelines for thromboplastins and plasma used to control oral anticoagulant therapy with vitamin K antagonists. Results Results were obtained from 20 laboratories. In several cases, deviations from the ISI calibration model were observed, but the average INR deviation attributabled to the model was not greater than 10%. Only valid ISI assessments were used to calculate the mean ISI for each candidate. The mean ISI for RBT/16 was 1.21 (between-laboratory coefficient of variation [CV]: 4.6%), and the mean ISI for rTF/16 was 1.11 (between-laboratory CV: 5.7%). Conclusions The between-laboratory variation of the ISI for candidate material RBT/16 was similar to that of the Fourth International Standard (RBT/05), and the between-laboratory variation of the ISI for candidate material rTF/16 was slightly higher than that of the Fourth International Standard (rTF/09). The candidate materials

  3. 25 CFR 543.8 - What are the minimum internal control standards for bingo?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for bingo? 543.8 Section 543.8 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.8 What are the minimum internal control standards for bingo? (a) Supervision....

  4. 25 CFR 543.8 - What are the minimum internal control standards for bingo?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 2 2013-04-01 2013-04-01 false What are the minimum internal control standards for bingo? 543.8 Section 543.8 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.8 What are the minimum internal control standards for bingo? (a) Supervision....

  5. 77 FR 37361 - National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-21

    ... National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion Engines; New Source Performance Standards for Stationary Internal Combustion Engines AGENCY: Environmental Protection... Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion Engines; New Source Performance...

  6. International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab.

    PubMed

    Prior, Sandra; Hufton, Simon E; Fox, Bernard; Dougall, Thomas; Rigsby, Peter; Bristow, Adrian

    2018-01-01

    The intrinsic complexity and heterogeneity of therapeutic monoclonal antibodies is built into the biosimilarity paradigm where critical quality attributes are controlled in exhaustive comparability studies with the reference medicinal product. The long-term success of biosimilars will depend on reassuring healthcare professionals and patients of consistent product quality, safety and efficacy. With this aim, the World Health Organization has endorsed the need for public bioactivity standards for therapeutic monoclonal antibodies in support of current controls. We have developed a candidate international potency standard for rituximab that was evaluated in a multi-center collaborative study using participants' own qualified Fc-effector function and cell-based binding bioassays. Dose-response curve model parameters were shown to reflect similar behavior amongst rituximab preparations, albeit with some differences in potency. In the absence of a common reference standard, potency estimates were in poor agreement amongst laboratories, but the use of the candidate preparation significantly reduced this variability. Our results suggest that the candidate rituximab standard can support bioassay performance and improve data harmonization, which when implemented will promote consistency of rituximab products over their life-cycles. This data provides the first scientific evidence that a classical standardization exercise allowing traceability of bioassay data to an international standard is also applicable to rituximab. However, we submit that this new type of international standard needs to be used appropriately and its role not to be mistaken with that of the reference medicinal product.

  7. International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab

    PubMed Central

    Prior, Sandra; Hufton, Simon E.; Dougall, Thomas; Rigsby, Peter; Bristow, Adrian

    2018-01-01

    ABSTRACT The intrinsic complexity and heterogeneity of therapeutic monoclonal antibodies is built into the biosimilarity paradigm where critical quality attributes are controlled in exhaustive comparability studies with the reference medicinal product. The long-term success of biosimilars will depend on reassuring healthcare professionals and patients of consistent product quality, safety and efficacy. With this aim, the World Health Organization has endorsed the need for public bioactivity standards for therapeutic monoclonal antibodies in support of current controls. We have developed a candidate international potency standard for rituximab that was evaluated in a multi-center collaborative study using participants' own qualified Fc-effector function and cell-based binding bioassays. Dose-response curve model parameters were shown to reflect similar behavior amongst rituximab preparations, albeit with some differences in potency. In the absence of a common reference standard, potency estimates were in poor agreement amongst laboratories, but the use of the candidate preparation significantly reduced this variability. Our results suggest that the candidate rituximab standard can support bioassay performance and improve data harmonization, which when implemented will promote consistency of rituximab products over their life-cycles. This data provides the first scientific evidence that a classical standardization exercise allowing traceability of bioassay data to an international standard is also applicable to rituximab. However, we submit that this new type of international standard needs to be used appropriately and its role not to be mistaken with that of the reference medicinal product. PMID:28985159

  8. 78 FR 37505 - International Standard-Setting Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-21

    ... Code of Practice for Weed Control to Prevent and Reduce Pyrrolizidine Alkaloid Contamination in Food... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2013-0002] International Standard-Setting Activities AGENCY: Office of Food Safety, USDA. ACTION: Notice. SUMMARY: This...

  9. 75 FR 31749 - International Standard-Setting Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-04

    ... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2009-0033] International Standard-Setting Activities AGENCY: Office of Food Safety, USDA. ACTION: Notice. SUMMARY: This..., and hand- or courier-delivered items: Send to Docket Clerk, U.S. Department of Agriculture, Food...

  10. 78 FR 6825 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1205] Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for Comments; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments...

  11. ISBT 128: a global information standard

    PubMed Central

    2010-01-01

    ISBT 128 is the global standard for the identification, labeling and information transfer of human blood, cell, tissue and organ products across international borders and disparate health care systems. The system has been designed and perfected over almost two decades to ensure accuracy, safety and efficiency for the benefit of donors, patients and health care workers worldwide. The use of the ISBT 128 standard has grown steadily since a blood bank in Estonia first implemented it in 1997. Today, more than 3,500 facility identifiers for the use of ISBT 128 have been assigned to organizations in 67 countries on six continents. The standard has been accepted by a variety of international standard setting organizations and government regulators. It is managed by ICCBBA, a not-for-profit organization based in the USA that is governed by an international volunteer board of directors. Members of the Board of Directors represent the fields of practice affected by the standard. Advisory groups comprising international experts guide the ongoing development of the ISBT 128 standard to ensure it continues to meet the needs of its users. While there is a cost associated with the implementation and use of the standard, the clear benefits in terms of improved patient safety and ability to meet regulatory traceability requirements justify the costs. PMID:20652420

  12. Standardization and future directions in pattern identification research: International brainstorming session.

    PubMed

    Jung, Jeeyoun; Park, Bongki; Lee, Ju Ah; You, Sooseong; Alraek, Terje; Bian, Zhao-Xiang; Birch, Stephen; Kim, Tae-Hun; Xu, Hao; Zaslawski, Chris; Kang, Byoung-Kab; Lee, Myeong Soo

    2016-09-01

    An international brainstorming session on standardizing pattern identification (PI) was held at the Korea Institute of Oriental Medicine on October 1, 2013 in Daejeon, South Korea. This brainstorming session was convened to gather insights from international traditional East Asian medicine specialists regarding PI standardization. With eight presentations and discussion sessions, the meeting allowed participants to discuss research methods and diagnostic systems used in traditional medicine for PI. One speaker presented a talk titled "The diagnostic criteria for blood stasis syndrome: implications for standardization of PI". Four speakers presented on future strategies and objective measurement tools that could be used in PI research. Later, participants shared information and methodology for accurate diagnosis and PI. They also discussed the necessity for standardizing PI and methods for international collaborations in pattern research.

  13. Food labeling issues in patients with severe food allergies: solving a hamlet-like doubt.

    PubMed

    Fierro, Vincenzo; Di Girolamo, Francesco; Marzano, Valeria; Dahdah, Lamia; Mennini, Maurizio

    2017-06-01

    We review the laws on labeling in the international community, the difficulties they pose to the food manufacturers to prepare the food labels and the methodologies to determine the concentration of potential allergens in foods. European Food Safety Authority and International Life Sciences Institute Europe are evaluating strategies to identify the threshold level of allergen that can trigger a reaction in individuals. The most used techniques to detect the presence of protein in food are Enzyme-linked immunosorbent assay, polymerase chain reaction and real time polymerase chain reaction. Researchers are now trying to apply proteomics to estimate the amount of protein within the food.In order to protect the health of consumers, the Codex Alimentarius Commission updates constantly the list of allergens. In response to these regulations, some industries have also added some precautionary allergen labeling (PAL). It was generally agreed that PAL statements needed to be visible, simple, and safe. It was suggested that PAL be standardized, an action that would occur if the 'Voluntary Incidental Trace Allergen Labelling' process was made mandatory. So far, no laboratory technique is able to reassure the consumers about the composition of foods found on the packaging. International authorities produced increasingly stringent laws, but more is still to do.

  14. Absolute Quantitation of Glycosylation Site Occupancy Using Isotopically Labeled Standards and LC-MS

    NASA Astrophysics Data System (ADS)

    Zhu, Zhikai; Go, Eden P.; Desaire, Heather

    2014-06-01

    N-linked glycans are required to maintain appropriate biological functions on proteins. Underglycosylation leads to many diseases in plants and animals; therefore, characterizing the extent of glycosylation on proteins is an important step in understanding, diagnosing, and treating diseases. To determine the glycosylation site occupancy, protein N-glycosidase F (PNGase F) is typically used to detach the glycan from the protein, during which the formerly glycosylated asparagine undergoes deamidation to become an aspartic acid. By comparing the abundance of the resulting peptide containing aspartic acid against the one containing non-glycosylated asparagine, the glycosylation site occupancy can be evaluated. However, this approach can give inaccurate results when spontaneous chemical deamidation of the non-glycosylated asparagine occurs. To overcome this limitation, we developed a new method to measure the glycosylation site occupancy that does not rely on converting glycosylated peptides to their deglycosylated forms. Specifically, the overall protein concentration and the non-glycosylated portion of the protein are quantified simultaneously by using heavy isotope-labeled internal standards coupled with LC-MS analysis, and the extent of site occupancy is accurately determined. The efficacy of the method was demonstrated by quantifying the occupancy of a glycosylation site on bovine fetuin. The developed method is the first work that measures the glycosylation site occupancy without using PNGase F, and it can be done in parallel with glycopeptide analysis because the glycan remains intact throughout the workflow.

  15. Human Rights and Values Education: Using the International Standards.

    ERIC Educational Resources Information Center

    Reardon, Betty A.

    1994-01-01

    Asserts that, in teaching about human rights, the international standards should be the fundamental core of the content and values to be communicated. Recommends that teachers should use the Universal Declaration of Human Rights as the standard by which the actions of individuals and governments should be compared. (CFR)

  16. Standard methods for sampling freshwater fishes: Opportunities for international collaboration

    USGS Publications Warehouse

    Bonar, Scott A.; Mercado-Silva, Norman; Hubert, Wayne A.; Beard, Douglas; Dave, Göran; Kubečka, Jan; Graeb, Brian D. S.; Lester, Nigel P.; Porath, Mark T.; Winfield, Ian J.

    2017-01-01

    With publication of Standard Methods for Sampling North American Freshwater Fishes in 2009, the American Fisheries Society (AFS) recommended standard procedures for North America. To explore interest in standardizing at intercontinental scales, a symposium attended by international specialists in freshwater fish sampling was convened at the 145th Annual AFS Meeting in Portland, Oregon, in August 2015. Participants represented all continents except Australia and Antarctica and were employed by state and federal agencies, universities, nongovernmental organizations, and consulting businesses. Currently, standardization is practiced mostly in North America and Europe. Participants described how standardization has been important for management of long-term data sets, promoting fundamental scientific understanding, and assessing efficacy of large spatial scale management strategies. Academics indicated that standardization has been useful in fisheries education because time previously used to teach how sampling methods are developed is now more devoted to diagnosis and treatment of problem fish communities. Researchers reported that standardization allowed increased sample size for method validation and calibration. Group consensus was to retain continental standards where they currently exist but to further explore international and intercontinental standardization, specifically identifying where synergies and bridges exist, and identify means to collaborate with scientists where standardization is limited but interest and need occur.

  17. International Labour Standards. A Workers' Education Manual.

    ERIC Educational Resources Information Center

    International Labour Office, Geneva (Switzerland).

    Concerned with the standard-setting work of the International Labor Organization (ILO), this manual is chiefly intended to provide guidance for worker's education instructors and trade union officials. It contains nine chapters: (1) the ILO origins and history are traced and the structure is explained; (2 & 3) procedures for the origination…

  18. Utilization of a deuterated derivatization agent to synthesize internal standards for gas chromatography-tandem mass spectrometry quantification of silylated metabolites.

    PubMed

    Lien, Stina K; Kvitvang, Hans Fredrik Nyvold; Bruheim, Per

    2012-07-20

    GC-MS analysis of silylated metabolites is a sensitive method that covers important metabolite groups such as sugars, amino acids and non-amino organic acids, and it has become one of the most important analytical methods for exploring the metabolome. Absolute quantitative GC-MS analysis of silylated metabolites poses a challenge as different metabolites have different derivatization kinetics and as their silyl-derivates have varying stability. This report describes the development of a targeted GC-MS/MS method for quantification of metabolites. Internal standards for each individual metabolite were obtained by derivatization of a mixture of standards with deuterated N-methyl-N-trimethylsilyltrifluoroacetamide (d9-MSTFA), and spiking this solution into MSTFA derivatized samples prior to GC-MS/MS analysis. The derivatization and spiking protocol needed optimization to ensure that the behaviour of labelled compound responses in the spiked sample correctly reflected the behaviour of unlabelled compound responses. Using labelled and unlabelled MSTFA in this way enabled normalization of metabolite responses by the response of their deuterated counterpart (i.e. individual correction). Such individual correction of metabolite responses reproducibly resulted in significantly higher precision than traditional data correction strategies when tested on samples both with and without serum and urine matrices. The developed method is thus a valuable contribution to the field of absolute quantitative metabolomics. Copyright © 2012 Elsevier B.V. All rights reserved.

  19. 21 CFR 610.67 - Bar code label requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Bar code label requirements. 610.67 Section 610.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements...

  20. 21 CFR 610.67 - Bar code label requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Bar code label requirements. 610.67 Section 610.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements...

  1. Development of PCR internal controls for DNA profiling with the AmpFℓSTR® SGM Plus® amplification kit.

    PubMed

    Nathalie, Zahra; Hadi, Sibte; Goodwin, William

    2012-09-01

    Forensic DNA profiling uses a series of commercial kits that co-amplify several loci in one reaction; the products of the PCR are fluorescently labelled and analysed using CE. Before CE, an aliquot of the PCR is mixed with formamide and an internal lane size standard. Using the SGM Plus amplification kit, we have developed two internal non-amplified controls of 80 bp and 380 bp that are labelled with ROX fluorescent dye and added to the PCR. Combined with two internal amplification controls of 90 bp and 410 bp, they provide additional controls for the PCR, electrokinetic injection, and CE and also function as an internal size standard. © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  2. Summary Brief: International Baccalaureate Standards Development and Alignment Project

    ERIC Educational Resources Information Center

    Conley, David T.; Ward, Terri

    2009-01-01

    Although the International Baccalaureate (IB) Diploma Programme is offered by many high schools in the United States and considered to be challenging and rich in content, the curriculum has not been analyzed to determine its alignment with college readiness standards or state educational standards in the U.S. The research methodology employed by…

  3. AAALAC International Standards and Accreditation Process

    PubMed Central

    Gettayacamin, Montip; Retnam, Leslie

    2017-01-01

    AAALAC International is a private, nonprofit organization that promotes humane treatment of animals in science through a voluntary international accreditation program. AAALAC International accreditation is recognized around the world as a symbol of high quality animal care and use for research, teaching and testing, as well as promoting animal welfare. Animals owned by the institution that are used for research, teaching and testing are included as part of an accredited program. More than 990 animal care and use institutions in 42 countries around the world (more than 170 programs in 13 countries in the Pacific Rim region) have earned AAALAC International accreditation. The AAALAC International Council on Accreditation evaluates overall performance and all aspects of an animal care and use program, involving an in-depth, multilayered, confidential peer-review process. The evaluators (site visitors) consider compliance with applicable local animal legislation of the host country, institutional policies, and employ a customized approach for evaluating overall program performance using a series of primary standards that include the Guide for the Care and Use of Laboratory Animals, the Guide for the Care and Use of Agricultural Animals in Research and Teaching, or the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Purposes, Council of Europe (ETS 123), and supplemental Reference Resources, as applicable. PMID:28744349

  4. 21 CFR 660.28 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.28 Labeling. In... white, except that all or a portion of the final container label of the following Blood Grouping... panel. Blood grouping reagent Color of label paper Anti-A Blue. Anti-B Yellow. Slide and rapid tube test...

  5. 21 CFR 660.28 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.28 Labeling. In... white, except that all or a portion of the final container label of the following Blood Grouping... panel. Blood grouping reagent Color of label paper Anti-A Blue. Anti-B Yellow. Slide and rapid tube test...

  6. 21 CFR 660.28 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.28 Labeling. In... white, except that all or a portion of the final container label of the following Blood Grouping... panel. Blood grouping reagent Color of label paper Anti-A Blue. Anti-B Yellow. Slide and rapid tube test...

  7. 21 CFR 660.28 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.28 Labeling. In... white, except that all or a portion of the final container label of the following Blood Grouping... panel. Blood grouping reagent Color of label paper Anti-A Blue. Anti-B Yellow. Slide and rapid tube test...

  8. 21 CFR 660.35 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Reagent Red Blood Cells § 660.35 Labeling. In... or end of the label, oustide of the main panel. (2) If washing the cells is required by the manufacturer, the container label shall include appropriate instructions; if the cells should not be washed...

  9. Internal Standards: A Source of Analytical Bias For Volatile Organic Analyte Determinations

    EPA Science Inventory

    The use of internal standards in the determination of volatile organic compounds as described in SW-846 Method 8260C introduces a potential for bias in results once the internal standards (ISTDs) are added to a sample for analysis. The bias is relative to the dissimilarity betw...

  10. 25 CFR 542.14 - What are the minimum internal control standards for the cage?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for the cage? 542.14 Section 542.14 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.14 What are the minimum internal control standards for the cage? (a) Computer applications. For...

  11. 25 CFR 543.9 - What are the minimum internal control standards for pull tabs?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 2 2013-04-01 2013-04-01 false What are the minimum internal control standards for pull tabs? 543.9 Section 543.9 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.9 What are the minimum internal control standards for pull tabs? (a)...

  12. 25 CFR 542.8 - What are the minimum internal control standards for pull tabs?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 2 2013-04-01 2013-04-01 false What are the minimum internal control standards for pull tabs? 542.8 Section 542.8 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.8 What are the minimum internal control standards for pull tabs? (a) Computer applications. For...

  13. 25 CFR 543.9 - What are the minimum internal control standards for pull tabs?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for pull tabs? 543.9 Section 543.9 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.9 What are the minimum internal control standards for pull tabs? (a)...

  14. 25 CFR 542.8 - What are the minimum internal control standards for pull tabs?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for pull tabs? 542.8 Section 542.8 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.8 What are the minimum internal control standards for pull tabs? (a) Computer applications. For...

  15. 25 CFR 542.8 - What are the minimum internal control standards for pull tabs?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 2 2012-04-01 2012-04-01 false What are the minimum internal control standards for pull tabs? 542.8 Section 542.8 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.8 What are the minimum internal control standards for pull tabs? (a) Computer applications. For...

  16. 78 FR 54606 - National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

    ... Combustion Engines; New Source Performance Standards for Stationary Internal Combustion Engines AGENCY... hazardous air pollutants for stationary reciprocating internal combustion engines and the standards of performance for stationary internal combustion engines. Subsequently, the EPA received three petitions for...

  17. 21 CFR 640.94 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Plasma Protein Fraction (Human) § 640.94 Labeling. In addition... package labels shall contain the following information: (a) The osmotic equivalent in terms of plasma, and...

  18. 21 CFR 640.94 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Plasma Protein Fraction (Human) § 640.94 Labeling. In addition... package labels shall contain the following information: (a) The osmotic equivalent in terms of plasma, and...

  19. 21 CFR 640.94 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Plasma Protein Fraction (Human) § 640.94 Labeling. In addition... package labels shall contain the following information: (a) The osmotic equivalent in terms of plasma, and...

  20. 21 CFR 640.94 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Plasma Protein Fraction (Human) § 640.94 Labeling. In addition... package labels shall contain the following information: (a) The osmotic equivalent in terms of plasma, and...

  1. 21 CFR 640.94 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Plasma Protein Fraction (Human) § 640.94 Labeling. In addition... package labels shall contain the following information: (a) The osmotic equivalent in terms of plasma, and...

  2. Serum apolipoprotein A-1 quantification by LC–MS with a SILAC internal standard reveals reduced levels in smokers

    PubMed Central

    Wang, Qingqing; Zhang, Suhong; Guo, Lili; Busch, Christine M; Jian, Wenying; Weng, Naidong; Snyder, Nathaniel W; Rangiah, Kannan; Mesaros, Clementina; Blair, Ian A

    2015-01-01

    Background: Absolute quantification of protein biomarkers such as serum apolipoprotein A1 by both immunoassays and LC–MS can provide misleading results. Results: Recombinant ApoA-1 internal standard was prepared using stable isotope labeling by amino acids in cell culture with [13C615N2]-lysine and [13C915N1]-tyrosine in human cells. A stable isotope dilution LC–MS method for serum ApoA-1 was validated and levels analyzed for 50 nonsmokers and 50 smokers. Conclusion: The concentration of ApoA-1 in nonsmokers was 169.4 mg/dl with an 18.4% reduction to 138.2 mg/dl in smokers. The validated assay will have clinical utility for assessing effects of smoking cessation and therapeutic or dietary interventions in high-risk populations. PMID:26394123

  3. 25 CFR 542.42 - What are the minimum internal control standards for internal audit for Tier C gaming operations?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... reconciliation process; (ii) Pull tabs, including but not limited to, statistical records, winner verification... 25 Indians 2 2010-04-01 2010-04-01 false What are the minimum internal control standards for... COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.42 What are...

  4. 25 CFR 542.22 - What are the minimum internal control standards for internal audit for Tier A gaming operations?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... but not limited to, bingo card control, payout procedures, and cash reconciliation process; (ii) Pull... 25 Indians 2 2010-04-01 2010-04-01 false What are the minimum internal control standards for... COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.22 What are...

  5. 25 CFR 542.32 - What are the minimum internal control standards for internal audit for Tier B gaming operations?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... but not limited to, bingo card control, payout procedures, and cash reconciliation process; (ii) Pull... 25 Indians 2 2010-04-01 2010-04-01 false What are the minimum internal control standards for... COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.32 What are...

  6. International Micrographics Standards: Report of the 1979 Paris Meeting of ISO/TC171.

    ERIC Educational Resources Information Center

    Heynen, Jeffrey

    1980-01-01

    Describes a meeting of the technical committee on micrographics of the International Organization for Standardization, and fcuses on the committee's work relating to the reproduction of library materials within the general context of international standards-making activities. (FM)

  7. Monitoring of protease catalyzed reactions by quantitative MALDI MS using metal labeling.

    PubMed

    Gregorius, Barbara; Jakoby, Thomas; Schaumlöffel, Dirk; Tholey, Andreas

    2013-05-21

    Quantitative mass spectrometry is a powerful tool for the determination of enzyme activities as it does not require labeled substrates and simultaneously allows for the identification of reaction products. However, major restrictions are the limited number of samples which can be measured in parallel due to the need for isotope labeled internal standards. Here we describe the use of metal labeling of peptides for the setup of multiplexed enzyme activity assays. After proteolytic reaction, using the protease trypsin, remaining substrates and peptide products formed in the reaction were labeled with metal chelators complexing rare earth metal ions. Labeled peptides were quantified with high accuracy and over a wide dynamic range (at least 2 orders of magnitude) using MALDI MS in case of simple peptide mixtures or by LC-MALDI MS for complex substrate mixtures and used for the monitoring of time-dependent product formation and substrate consumption. Due to multiplexing capabilities and accuracy, the presented approach will be useful for the determination of enzyme activities with a wide range of biochemical and biotechnological applications.

  8. Improving the efficiency of quantitative (1)H NMR: an innovative external standard-internal reference approach.

    PubMed

    Huang, Yande; Su, Bao-Ning; Ye, Qingmei; Palaniswamy, Venkatapuram A; Bolgar, Mark S; Raglione, Thomas V

    2014-01-01

    The classical internal standard quantitative NMR (qNMR) method determines the purity of an analyte by the determination of a solution containing the analyte and a standard. Therefore, the standard must meet the requirements of chemical compatibility and lack of resonance interference with the analyte as well as a known purity. The identification of such a standard can be time consuming and must be repeated for each analyte. In contrast, the external standard qNMR method utilizes a standard with a known purity to calibrate the NMR instrument. The external standard and the analyte are measured separately, thereby eliminating the matter of chemical compatibility and resonance interference between the standard and the analyte. However, the instrumental factors, including the quality of NMR tubes, must be kept the same. Any deviations will compromise the accuracy of the results. An innovative qNMR method reported herein utilizes an internal reference substance along with an external standard to assume the role of the standard used in the traditional internal standard qNMR method. In this new method, the internal reference substance must only be chemically compatible and be free of resonance-interference with the analyte or external standard whereas the external standard must only be of a known purity. The exact purity or concentration of the internal reference substance is not required as long as the same quantity is added to the external standard and the analyte. The new method reduces the burden of searching for an appropriate standard for each analyte significantly. Therefore the efficiency of the qNMR purity assay increases while the precision of the internal standard method is retained. Copyright © 2013 Elsevier B.V. All rights reserved.

  9. [From manual workshop to international standard maker: exploration on production standard of acupuncture needle by Chengjiang acupuncture school].

    PubMed

    Cheng, Jie; Cao, Yang; Xia, Youbing

    2015-02-01

    ABSTRACT The exploration course on production standard of acupuncture needle by Chengjiang acupuncture school is reviewed in this paper. After new China was established, acupuncture needle standard was unified by Mr. CHENG Dan-an, which guided Suzhou Hua Erfang (predecessor of Suzhou Medical Supplies Factory) to make the quality standards and testing methods of acupuncture needle and improved the production process to make the modern acupuncture needle. Based on this, Suzhou Medical Supplies Factory followed the time development pace, ac tively introduced new technology, carried out technological innovation, and constantly improved the level of production technology, as a result, it gradually developed into one of the world's largest acupuncture needle production suppliers. Meanwhile, after establishing China's first national standard on acupuncture needle (GB 2024-1980), the Suzhou Medical Supplies Factory took the lead to draft "ISO) 17218:2014 the disposable use asepsis acupuncture needle", which was officially published as an international standard. The Suzhou Medical Supplies Factory developed from a manual workshop to an international standard maker.

  10. Adaptations of International Standards on Educational Leadership Preparation in Egypt

    ERIC Educational Resources Information Center

    Purinton, Ted; Khalil, Dalia

    2016-01-01

    This paper is a case study of one leadership preparation program, utilizing US school leadership standards and practices, offered in Egypt. This case study illuminates how cultural and policy distinctions impact differing necessities of educational leadership, and how those necessities conflict or concur with the international standards and…

  11. Synthesis of a doxycycline-[(13) CD3 ] standard.

    PubMed

    Bupp, James E; Tanga, Mary J

    2016-06-15

    A stable isotope labelled mass spectrometry internal standard of the antibiotic doxycycline was prepared to assist in pharmacokinetic analyses. Our approach was to first N-demethylate doxycycline using a non-classical Polonovski reaction and then re-methylate using methyl-[(13) CD3 ] iodide, which gave doxycycline-[(13) CD3 ] with an isotopic purity of 99%. Copyright © 2016 John Wiley & Sons, Ltd.

  12. An Internal Standard for Assessing Phosphopeptide Recovery from Metal Ion/Oxide Enrichment Strategies

    NASA Astrophysics Data System (ADS)

    Paulo, Joao A.; Navarrete-Perea, Jose; Erickson, Alison R.; Knott, Jeffrey; Gygi, Steven P.

    2018-04-01

    Phosphorylation-mediated signaling pathways have major implications in cellular regulation and disease. However, proteins with roles in these pathways are frequently less abundant and phosphorylation is often sub-stoichiometric. As such, the efficient enrichment, and subsequent recovery of phosphorylated peptides, is vital. Mass spectrometry-based proteomics is a well-established approach for quantifying thousands of phosphorylation events in a single experiment. We designed a peptide internal standard-based assay directed toward sample preparation strategies for mass spectrometry analysis to understand better phosphopeptide recovery from enrichment strategies. We coupled mass-differential tandem mass tag (mTMT) reagents (specifically, TMTzero and TMTsuper-heavy), nine mass spectrometry-amenable phosphopeptides (phos9), and peak area measurements from extracted ion chromatograms to determine phosphopeptide recovery. We showcase this mTMT/phos9 recovery assay by evaluating three phosphopeptide enrichment workflows. Our assay provides data on the recovery of phosphopeptides, which complement other metrics, namely the number of identified phosphopeptides and enrichment specificity. Our mTMT/phos9 assay is applicable to any enrichment protocol in a typical experimental workflow irrespective of sample origin or labeling strategy. [Figure not available: see fulltext.

  13. 25 CFR 543.17 - What are the minimum internal control standards for drop and count?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 2 2013-04-01 2013-04-01 false What are the minimum internal control standards for drop and count? 543.17 Section 543.17 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.17 What are the minimum internal control standards for drop and count?...

  14. 25 CFR 543.15 - What are the minimum internal control standards for lines of credit?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 2 2013-04-01 2013-04-01 false What are the minimum internal control standards for lines of credit? 543.15 Section 543.15 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.15 What are the minimum internal control standards for lines of credi...

  15. 25 CFR 543.15 - What are the minimum internal control standards for lines of credit?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for lines of credit? 543.15 Section 543.15 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.15 What are the minimum internal control standards for lines of credi...

  16. 25 CFR 543.17 - What are the minimum internal control standards for drop and count?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for drop and count? 543.17 Section 543.17 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.17 What are the minimum internal control standards for drop and count?...

  17. Ra‐224 labeling of calcium carbonate microparticles for internal α‐therapy: Preparation, stability, and biodistribution in mice

    PubMed Central

    Westrøm, Sara; Malenge, Marion; Jorstad, Ida Sofie; Napoli, Elisa; Bruland, Øyvind S.; Bønsdorff, Tina B.

    2018-01-01

    Internal therapy with α‐emitters should be well suited for micrometastatic disease. Radium‐224 emits multiple α‐particles through its decay and has a convenient 3.6 days of half‐life. Despite its attractive properties, the use of 224Ra has been limited to bone‐seeking applications because it cannot be stably bound to a targeting molecule. Alternative delivery systems for 224Ra are therefore of considerable interest. In this study, calcium carbonate microparticles are proposed as carriers for 224Ra, designed for local therapy of disseminated cancers in cavitary regions, such as peritoneal carcinomatosis. Calcium carbonate microparticles were radiolabeled by precipitation of 224Ra on the particle surface, resulting in high labeling efficiencies for both 224Ra and daughter 212Pb and retention of more than 95% of these nuclides for up to 1 week in vitro. The biodistribution after intraperitoneal administration of the 224Ra‐labeled CaCO3 microparticles in immunodeficient mice revealed that the radioactivity mainly remained in the peritoneal cavity. In addition, the systemic distribution of 224Ra was found to be strongly dependent on the amount of administered microparticles, with a reduced skeletal uptake of 224Ra with increasing dose. The results altogether suggest that the 224Ra‐labeled CaCO3 microparticles have promising properties for use as a localized internal α‐therapy of cavitary cancers. PMID:29380410

  18. Australian and New Zealand Fish Oil Products in 2016 Meet Label Omega-3 Claims and Are Not Oxidized.

    PubMed

    Nichols, Peter D; Dogan, Lalen; Sinclair, Andrew

    2016-11-05

    We provide new fish oil product results to assist industry in Australia and New Zealand and, ultimately, consumers in understanding the high product quality assurance protocols in place, together with the high product quality that has been determined by both industry and independent laboratories. Fish oil capsule products common to Australia and New Zealand were purchased in May 2016 in Richmond, Victoria, Australia. Products were from two groups; five standard fish oil products and five fish oil concentrates. Noting Therapeutic Goods Administration (TGA) requirement for use of standard methods, for all analyses undertaken a laboratory was selected that met the TGA criteria, including with accreditation. Total n -3 content exceeded the label-claimed content for all 10 products, with supplements containing on average 124% of the claimed content (range 115%-136%); eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) content averaged 109% of the label claim (range 99%-119%). All 10 products (100%) similarly met the international recommended peroxide value (PV) level. Anisidine value (pAV) met the international recommended level for eight of the 10 products, with two products known to contain flavorings that interfere with the pAV test. When accredited laboratories and standard protocols are used, Australian and New Zealand fish oil products have been shown to clearly meet their label claims for EPA + DHA content, and are not oxidized.

  19. Australian and New Zealand Fish Oil Products in 2016 Meet Label Omega-3 Claims and Are Not Oxidized

    PubMed Central

    Nichols, Peter D.; Dogan, Lalen; Sinclair, Andrew

    2016-01-01

    We provide new fish oil product results to assist industry in Australia and New Zealand and, ultimately, consumers in understanding the high product quality assurance protocols in place, together with the high product quality that has been determined by both industry and independent laboratories. Fish oil capsule products common to Australia and New Zealand were purchased in May 2016 in Richmond, Victoria, Australia. Products were from two groups; five standard fish oil products and five fish oil concentrates. Noting Therapeutic Goods Administration (TGA) requirement for use of standard methods, for all analyses undertaken a laboratory was selected that met the TGA criteria, including with accreditation. Total n-3 content exceeded the label-claimed content for all 10 products, with supplements containing on average 124% of the claimed content (range 115%–136%); eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) content averaged 109% of the label claim (range 99%–119%). All 10 products (100%) similarly met the international recommended peroxide value (PV) level. Anisidine value (pAV) met the international recommended level for eight of the 10 products, with two products known to contain flavorings that interfere with the pAV test. When accredited laboratories and standard protocols are used, Australian and New Zealand fish oil products have been shown to clearly meet their label claims for EPA + DHA content, and are not oxidized. PMID:27827947

  20. A Metadata Standard for Hydroinformatic Data Conforming to International Standards

    NASA Astrophysics Data System (ADS)

    Notay, Vikram; Carstens, Georg; Lehfeldt, Rainer

    2017-04-01

    The affordable availability of computing power and digital storage has been a boon for the scientific community. The hydroinformatics community has also benefitted from the so-called digital revolution, which has enabled the tackling of more and more complex physical phenomena using hydroinformatic models, instruments, sensors, etc. With models getting more and more complex, computational domains getting larger and the resolution of computational grids and measurement data getting finer, a large amount of data is generated and consumed in any hydroinformatics related project. The ubiquitous availability of internet also contributes to this phenomenon with data being collected through sensor networks connected to telecommunications networks and the internet long before the term Internet of Things existed. Although generally good, this exponential increase in the number of available datasets gives rise to the need to describe this data in a standardised way to not only be able to get a quick overview about the data but to also facilitate interoperability of data from different sources. The Federal Waterways Engineering and Research Institute (BAW) is a federal authority of the German Federal Ministry of Transport and Digital Infrastructure. BAW acts as a consultant for the safe and efficient operation of the German waterways. As part of its consultation role, BAW operates a number of physical and numerical models for sections of inland and marine waterways. In order to uniformly describe the data produced and consumed by these models throughout BAW and to ensure interoperability with other federal and state institutes on the one hand and with EU countries on the other, a metadata profile for hydroinformatic data has been developed at BAW. The metadata profile is composed in its entirety using the ISO 19115 international standard for metadata related to geographic information. Due to the widespread use of the ISO 19115 standard in the existing geodata infrastructure

  1. Determinants of Effective Information Transfer in International Regulatory Standards Adoption

    ERIC Educational Resources Information Center

    Popescu, Denisa

    2010-01-01

    The role of international regulatory standards within the current global environment has become of the most importance. The age of the global system and free market capitalism carried us into the unprecedented age of regulations, and standard setting. Regulations are now becoming the emerging mode of global governance. This study focuses on…

  2. Restructuring of international council for standardization in haematology (ICSH) in Asia.

    PubMed

    Tatsumi, N; Lewis, S M

    2002-08-01

    Standardization and harmonization in Laboratory testing are a key issue in the midst of globalization era, because most of laboratory testing has been currently achieved with various kinds of automated systems. In the developed countries, automated systems with highly-regulated principles are commonly used in the routine laboratory. However, there are so many undeveloped and developing countries in Asia that diversity of testing levels can be observed in the area. Some laboratories use glass chamber method for blood cell counting, while other laboratory use semi-automated or fully automated analyzers for complete blood count. International standardization on Hematology is focused on the developed system but not for the developing system. Established standardized documents therefore whould not be unsuitable for Asian societies. In the context, International Council for Standardization in Hematology (ICSH) changed its rules to adjust our Asian Societies and ICSH started to restructure the body. International ICSH society is divided into 5 region sub-groups. Asian area is able to possess one new sub-society, ICSH-Asia. Its reconstruction work has been just started with Asain colleagues, and we are now extending the new societies to discuss Asian problems on the quality of hematology testing.

  3. What States Should Know about International Standards in Science: Highlights from Achieve's Analysis

    ERIC Educational Resources Information Center

    Achieve, Inc., 2010

    2010-01-01

    Achieve, through support from the Noyce Foundation, examined ten sets of international standards with the intent of informing the development of both the conceptual framework and Next Generation Science Standards. Achieve selected countries based on their strong performance on international assessments and/or their economic, political, or cultural…

  4. 76 FR 62714 - Lifesaving Equipment: Production Testing and Harmonization With International Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-11

    ... apply to: prototypes (new designs) submitted after January 1, 2012; production testing of designs... Lifesaving Equipment: Production Testing and Harmonization With International Standards AGENCY: Coast Guard... and Standards Directorate, Office of Design and Engineering Standards, Lifesaving and Fire Safety...

  5. International standards for optical wireless communications: state-of-the-art and future directions

    NASA Astrophysics Data System (ADS)

    Marciniak, Marian

    2017-10-01

    As the number of active OWC installations is growing fast, the standards for compatibility of co-existing neighbouring systems are being developed. The paper addresses the Laser Safety (IEC standards), ITU-T Study Group 15 standards (G.640 Co-location longitudinally compatible interfaces for free space optical systems), ITU-Radiocommunication Sector standards (P.1817-1 Propagation data required for the design of terrestrial free-space optical links), and the IEEE Work in Progress - standardization activity on Visible Light Communications. International standards of FSO communications have been reviewed and discussed. ITU, IEC, and IEEE International standards for Free-Space Optical links have been reviewed. The system reliability and availability as well as security issues will be addressed as well in the talk.

  6. Biosynthesis and characterization of ¹⁵N₆-labeled phomopsin A, a lupin associated mycotoxin produced by Diaporthe toxica.

    PubMed

    Schloß, Svenja; Wedell, Ines; Koch, Matthias; Rohn, Sascha; Maul, Ronald

    2015-06-15

    The hepatotoxin phomopsin A (PHO-A), a secondary metabolite mainly produced by the fungus Diaporthe toxica, occurs predominantly on sweet lupins. Along with the growing interest in sweet lupins for food and feed commodities, concerns have been raised about fungal infestations, and consequently, about the determination of PHO-A. High performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) represents the most suitable analytical technique for sensitive and selective detection of mycotoxins including PHO-A. However, isotopic labeled substances are needed as internal standards for a reliable and convenient quantification. As no isotope standard for PHO-A is currently available, a biosynthesis of fully (15)N6-labeled PHO-A was established by cultivation of D. toxica on defined media containing Na(15)NO3 and (15)N-labeled yeast extract as the only nitrogen sources. The identity of (15)N6-PHO-A was confirmed by high resolution mass spectrometry. The new (15)N6-labeled standard will facilitate the method development for PHO-A including a more accurate quantification by LC-MS/MS. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. ISO 639-1 and ISO 639-2: International Standards for Language Codes. ISO 15924: International Standard for Names of Scripts.

    ERIC Educational Resources Information Center

    Byrum, John D.

    This paper describes two international standards for the representation of the names of languages. The first (ISO 639-1), published in 1988, provides two-letter codes for 136 languages and was produced primarily to meet terminological needs. The second (ISO 639-2) appeared in late 1998 and includes three-letter codes for 460 languages. This list…

  8. INTERNATIONAL STANDARDS ON FOOD AND ENVIRONMENTAL RADIOACTIVITY MEASUREMENT FOR RADIOLOGICAL PROTECTION: STATUS AND PERSPECTIVES.

    PubMed

    Calmet, D; Ameon, R; Bombard, A; Brun, S; Byrde, F; Chen, J; Duda, J-M; Forte, M; Fournier, M; Fronka, A; Haug, T; Herranz, M; Husain, A; Jerome, S; Jiranek, M; Judge, S; Kim, S B; Kwakman, P; Loyen, J; LLaurado, M; Michel, R; Porterfield, D; Ratsirahonana, A; Richards, A; Rovenska, K; Sanada, T; Schuler, C; Thomas, L; Tokonami, S; Tsapalov, A; Yamada, T

    2017-04-01

    Radiological protection is a matter of concern for members of the public and thus national authorities are more likely to trust the quality of radioactivity data provided by accredited laboratories using common standards. Normative approach based on international standards aims to ensure the accuracy or validity of the test result through calibrations and measurements traceable to the International System of Units. This approach guarantees that radioactivity test results on the same types of samples are comparable over time and space as well as between different testing laboratories. Today, testing laboratories involved in radioactivity measurement have a set of more than 150 international standards to help them perform their work. Most of them are published by the International Standardization Organization (ISO) and the International Electrotechnical Commission (IEC). This paper reviews the most essential ISO standards that give guidance to testing laboratories at different stages from sampling planning to the transmission of the test report to their customers, summarizes recent activities and achievements and present the perspectives on new standards under development by the ISO Working Groups dealing with radioactivity measurement in connection with radiological protection. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  9. Consumer preferences for food allergen labeling.

    PubMed

    Marra, Carlo A; Harvard, Stephanie; Grubisic, Maja; Galo, Jessica; Clarke, Ann; Elliott, Susan; Lynd, Larry D

    2017-01-01

    Food allergen labeling is an important tool to reduce risk of exposure and prevent anaphylaxis for individuals with food allergies. Health Canada released a Canadian food allergen labeling regulation (2008) and subsequent update (2012) suggesting that research is needed to guide further iterations of the regulation to improve food allergen labeling and reduce risk of exposure. The primary objective of this study was to examine consumer preferences in food labeling for allergy avoidance and anaphylaxis prevention. A secondary objective was to identify whether different subgroups within the consumer population emerged. A discrete choice experiment using a fractional factorial design divided into ten different versions with 18 choice-sets per version was developed to examine consumer preferences for different attributes of food labeling. Three distinct subgroups of Canadian consumers with different allergen considerations and food allergen labeling needs were identified. Overall, preferences for standardized precautionary and safety symbols at little or no increased cost emerged. While three distinct groups with different preferences were identified, in general the results revealed that the current Canadian food allergen labeling regulation can be improved by enforcing the use of standardized precautionary and safety symbols and educating the public on the use of these symbols.

  10. Chapter 23: International Standard reagents for harmonization of HPV serology and DNA assays--an update.

    PubMed

    Pagliusi, Sonia R; Dillner, Joakim; Pawlita, Michael; Quint, Wim G V; Wheeler, Cosette M; Ferguson, M

    2006-08-31

    International reference materials such as International Standard reagents facilitate quality assurance of essential biopharmaceutical products and related in vitro diagnostic tests. Standardization of antibody and DNA measurements and harmonization of laboratory procedures are key to the success of cancer prevention strategies through screening methods as well as for development and implementation of vaccination against the human papillomavirus (HPV). The WHO supported the preparation and initial analysis of a panel of candidate serological and DNA reference reagents aimed at facilitating inter-laboratory comparisons and detection of HPV worldwide. Two international collaborative studies assessed the performance of various HPV antibody and HPV-DNA detection assays and examined the feasibility of generating HPV antibody and DNA standard reagents. These studies showed that improvement in performance and comparability of assays is urgently needed and that the use of the same International Standard reference reagent could significantly improve performance and comparability. It is hoped that the establishment of International Units and International Standards for HPV antibody and DNA analysis will be pursued with high priority.

  11. Software database creature for investment property measurement according to international standards

    NASA Astrophysics Data System (ADS)

    Ponomareva, S. V.; Merzliakova, N. A.

    2018-05-01

    The article deals with investment property measurement and accounting problems at the international, national and enterprise levels. The need to create the software for investment property measurement according to International Accounting Standards was substantiated. The necessary software functions and the processes were described.

  12. 10 CFR 835.605 - Labeling items and containers.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Labeling items and containers. 835.605 Section 835.605 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.605 Labeling... shall bear a durable, clearly visible label bearing the standard radiation warning trefoil and the words...

  13. 10 CFR 835.605 - Labeling items and containers.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Labeling items and containers. 835.605 Section 835.605 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.605 Labeling... shall bear a durable, clearly visible label bearing the standard radiation warning trefoil and the words...

  14. 10 CFR 835.605 - Labeling items and containers.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Labeling items and containers. 835.605 Section 835.605 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.605 Labeling... shall bear a durable, clearly visible label bearing the standard radiation warning trefoil and the words...

  15. 10 CFR 835.605 - Labeling items and containers.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Labeling items and containers. 835.605 Section 835.605 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.605 Labeling... shall bear a durable, clearly visible label bearing the standard radiation warning trefoil and the words...

  16. Relationship between internal medicine program board examination pass rates, accreditation standards, and program size.

    PubMed

    Falcone, John L; Gonzalo, Jed D

    2014-01-19

    To determine Internal Medicine residency program compliance with the Accreditation Council for Graduate Medical Education 80% pass-rate standard and the correlation between residency program size and performance on the American Board of Internal Medicine Certifying Examination. Using a cross-sectional study design from 2010-2012 American Board of Internal Medicine Certifying Examination data of all Internal Medicine residency pro-grams, comparisons were made between program pass rates to the Accreditation Council for Graduate Medical Education pass-rate standard. To assess the correlation between program size and performance, a Spearman's rho was calculated. To evaluate program size and its relationship to the pass-rate standard, receiver operative characteristic curves were calculated. Of 372 Internal Medicine residency programs, 276 programs (74%) achieved a pass rate of =80%, surpassing the Accreditation Council for Graduate Medical Education minimum standard. A weak correlation was found between residency program size and pass rate for the three-year period (p=0.19, p<0.001). The area underneath the receiver operative characteristic curve was 0.69 (95% Confidence Interval [0.63-0.75]), suggesting programs with less than 12 examinees/year are less likely to meet the minimum Accreditation Council for Graduate Medical Education pass-rate standard (sensitivity 63.8%, specificity 60.4%, positive predictive value 82.2%, p<0.001). Although a majority of Internal Medicine residency programs complied with Accreditation Council for Graduate Medical Education pass-rate standards, a quarter of the programs failed to meet this requirement. Program size is positively but weakly associated with American Board of Internal Medicine Certifying Examination performance, suggesting other unidentified variables significantly contribute to program performance.

  17. 25 CFR 542.17 - What are the minimum internal control standards for complimentary services or items?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 2 2011-04-01 2011-04-01 false What are the minimum internal control standards for complimentary services or items? 542.17 Section 542.17 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.17 What are the minimum internal control standards for complimentary...

  18. 25 CFR 542.17 - What are the minimum internal control standards for complimentary services or items?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 2 2012-04-01 2012-04-01 false What are the minimum internal control standards for complimentary services or items? 542.17 Section 542.17 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.17 What are the minimum internal control standards for complimentary...

  19. 25 CFR 542.17 - What are the minimum internal control standards for complimentary services or items?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 2 2013-04-01 2013-04-01 false What are the minimum internal control standards for complimentary services or items? 542.17 Section 542.17 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.17 What are the minimum internal control standards for complimentary...

  20. 25 CFR 542.17 - What are the minimum internal control standards for complimentary services or items?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for complimentary services or items? 542.17 Section 542.17 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.17 What are the minimum internal control standards for complimentary...

  1. Absolute quantification of protein NP24 in tomato fruit by liquid chromatography/tandem mass spectrometry using stable isotope-labelled tryptic peptide standard.

    PubMed

    Ippoushi, Katsunari; Sasanuma, Motoe; Oike, Hideaki; Kobori, Masuko; Maeda-Yamamoto, Mari

    2015-04-15

    Protein NP24 is a thaumatin-like protein contained in tomato (Lycopersicon esculentum Mill.). This protein is reported to be a putative tomato allergen and is listed as a food allergen in Structural Database of Allergenic Proteins (SDAP). In this research, we developed the quantitative analysis of NP24 by employing the protein absolute quantification (AQUA) technology composed of stable isotope-labelled internal standard (SIIS) peptide (GQTWVINAPR[(13)C6,(15)N4]) and liquid chromatography/tandem mass spectrometry (LC/MS/MS). A linear relationship (r(2)>0.99) was found throughout the concentration range (2.0-500 fmol/μL). The coefficients of variation (CVs) measured on each of the five days when NP24 contained in the tomato skin was analysed did not exceed 13%. Our developed assay of NP24 will contribute to the allergological examination of tomato and its derived products. Copyright © 2014 Elsevier Ltd. All rights reserved.

  2. 25 CFR 543.13 - What are the minimum internal control standards for complimentary services or items?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 2 2013-04-01 2013-04-01 false What are the minimum internal control standards for complimentary services or items? 543.13 Section 543.13 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.13 What are the minimum internal control standards fo...

  3. 25 CFR 543.13 - What are the minimum internal control standards for complimentary services or items?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for complimentary services or items? 543.13 Section 543.13 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.13 What are the minimum internal control standards fo...

  4. 21 CFR 610.67 - Bar code label requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... or to blood and blood components intended for transfusion. For blood and blood components intended...) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements. Biological products must comply with the bar code requirements at § 201.25 of this chapter. However, the bar...

  5. 21 CFR 610.67 - Bar code label requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... or to blood and blood components intended for transfusion. For blood and blood components intended...) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements. Biological products must comply with the bar code requirements at § 201.25 of this chapter. However, the bar...

  6. 21 CFR 610.67 - Bar code label requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... or to blood and blood components intended for transfusion. For blood and blood components intended...) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements. Biological products must comply with the bar code requirements at § 201.25 of this chapter. However, the bar...

  7. Defending strong tobacco packaging and labelling regulations in Uruguay: transnational tobacco control network versus Philip Morris International.

    PubMed

    Crosbie, Eric; Sosa, Particia; Glantz, Stanton A

    2018-03-01

    Describe the process of enacting and defending strong tobacco packaging and labelling regulations in Uruguay amid Philip Morris International's (PMI) legal threats and challenges. Triangulated government legislation, news sources and interviews with policy-makers and health advocates in Uruguay. In 2008 and 2009, the Uruguayan government enacted at the time the world's largest pictorial health warning labels (80% of front and back of package) and prohibited different packaging or presentations for cigarettes sold under a given brand. PMI threatened to sue Uruguay in international courts if these policies were implemented. The Vazquez administration maintained the regulations, but a week prior to President Vazquez's successor, President Mujica, took office on 1 March 2010 PMI announced its intention to file an investment arbitration dispute against Uruguay in the International Centre for the Settlement of Investment Disputes. Initially, the Mujica administration announced it would weaken the regulations to avoid litigation. In response, local public health groups in Uruguay enlisted former President Vazquez and international health groups and served as brokers to develop a collaboration with the Mujica administration to defend the regulations. This united front between the Uruguayan government and the transnational tobacco control network paid off when Uruguay defeated PMI's investment dispute in July 2016. To replicate Uruguay's success, other countries need to recognise that strong political support, an actively engaged local civil society and financial and technical support are important factors in overcoming tobacco industry's legal threats to defend strong public health regulations. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. ALE: automated label extraction from GEO metadata.

    PubMed

    Giles, Cory B; Brown, Chase A; Ripperger, Michael; Dennis, Zane; Roopnarinesingh, Xiavan; Porter, Hunter; Perz, Aleksandra; Wren, Jonathan D

    2017-12-28

    NCBI's Gene Expression Omnibus (GEO) is a rich community resource containing millions of gene expression experiments from human, mouse, rat, and other model organisms. However, information about each experiment (metadata) is in the format of an open-ended, non-standardized textual description provided by the depositor. Thus, classification of experiments for meta-analysis by factors such as gender, age of the sample donor, and tissue of origin is not feasible without assigning labels to the experiments. Automated approaches are preferable for this, primarily because of the size and volume of the data to be processed, but also because it ensures standardization and consistency. While some of these labels can be extracted directly from the textual metadata, many of the data available do not contain explicit text informing the researcher about the age and gender of the subjects with the study. To bridge this gap, machine-learning methods can be trained to use the gene expression patterns associated with the text-derived labels to refine label-prediction confidence. Our analysis shows only 26% of metadata text contains information about gender and 21% about age. In order to ameliorate the lack of available labels for these data sets, we first extract labels from the textual metadata for each GEO RNA dataset and evaluate the performance against a gold standard of manually curated labels. We then use machine-learning methods to predict labels, based upon gene expression of the samples and compare this to the text-based method. Here we present an automated method to extract labels for age, gender, and tissue from textual metadata and GEO data using both a heuristic approach as well as machine learning. We show the two methods together improve accuracy of label assignment to GEO samples.

  9. 78 FR 14457 - National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-06

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 60 and 63 [EPA-HQ-OAR-2008-0708, FRL-9756-4] RIN 2060-AQ58 National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion Engines; New Source Performance Standards for Stationary Internal Combustion Engines Correction In rule...

  10. 7 CFR 300.5 - International Standards for Phytosanitary Measures.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false International Standards for Phytosanitary Measures. 300.5 Section 300.5 Agriculture Regulations of the Department of Agriculture (Continued) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE INCORPORATION BY REFERENCE § 300.5...

  11. The Internal Medicine of the 21st century: Organizational and operational standards.

    PubMed

    Casariego-Vales, E; Zapatero-Gaviria, A; Elola-Somoza, F J

    2017-12-01

    The Spanish Society of Internal Medicine has developed a consensus document on the standards and recommendations that they consider essential to the organisation of internal medicine units for conducting their activities efficiently and with high quality. We defined 3 groups of key processes: the care of acutely ill adult patients, the comprehensive care of complex chronic patients and the examination of a patient with a difficult diagnosis and no organ-specific disease. As support processes, we identified the structure and operation of the Internal Medicine units. As strategic processes, we identified training and research. The main subprocesses are structured below, and we established the standards and recommendations for each of them. Lastly, we proposed resulting workloads. The prepared standards must be reviewed within a maximum of 4 years. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  12. To recognize the use of international standards for making harmonized regulation of medical devices in Asia-pacific.

    PubMed

    Anand, K; Saini, Ks; Chopra, Y; Binod, Sk

    2010-07-01

    'Medical Devices' include everything from highly sophisticated, computerized, medical equipment, right down to simple wooden tongue depressors. Regulations embody the public expectations for how buildings and facilities are expected to perform and as such represent public policy. Regulators, who develop and enforce regulations, are empowered to act in the public's interest to set this policy and are ultimately responsible to the public in this regard. Standardization contributes to the basic infrastructure that underpins society including health and environment, while promoting sustainability and good regulatory practice. The international organizations that produce International Standards are the International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO), and the International Telecommunication Union (ITU). With the increasing globalization of markets, International Standards (as opposed to regional or national standards) have become critical to the trading process, ensuring a level playing field for exports, and ensuring that imports meet the internationally recognized levels of performance and safety. The development of standards is done in response to sectors and stakeholders that express a clearly established need for them. An industry sector or other stakeholder group typically communicates its requirement for standards to one of the national members. To be accepted for development, a proposed work item must receive a majority support of the participating members, who verify the global relevance of the proposed item. The regulatory authority (RA) should provide a method for the recognition of international voluntary standards and for public notification of such recognition. The process of recognition may vary from country to country. Recognition may occur by periodic publication of lists of standards that a regulatory authority has found will meet the Essential Principles. In conclusion, International standards

  13. Why Adoption of Standards Matters

    ERIC Educational Resources Information Center

    Journal of Staff Development, 2016

    2016-01-01

    A total of 39 states have adopted, adapted, or endorsed the Standards for Professional Learning, including the standards issued in 2011 (labeled in red) and those published earlier (labeled in blue). Making a commitment to the standards is a commitment to continuous learning for all educators in a school.

  14. 75 FR 80761 - National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-23

    ... National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion Engines... March 3, 2010, final national emission standards for hazardous air pollutants for reciprocating internal... engines to allow emergency engines to operate for up to 15 hours per year as part of an emergency demand...

  15. Discourse Surrounding the International Education Standards for Professional Accountants (IES): A Content Analysis Approach

    ERIC Educational Resources Information Center

    Sugahara, Satoshi; Wilson, Rachel

    2013-01-01

    The development and implementation of the International Education Standards (IES) for professional accountants is currently an important issue in accounting education and for educators interested in a shift toward international education standards more broadly. The purpose of this study is to investigate professional and research discourse…

  16. ISBT 128 Standard for Coding Medical Products of Human Origin

    PubMed Central

    Ashford, Paul; Delgado, Matthew

    2017-01-01

    Background ISBT 128 is an international standard for the terminology, coding, labeling, and identification of medical products of human origin (MPHO). Full implementation of ISBT 128 improves traceability, transparency, vigilance and surveillance, and interoperability. Methods ICCBBA maintains the ISBT 128 standard through the activities of a network of expert volunteers, including representatives from professional scientific societies, governments and users, to standardize and maintain MPHO identification. These individuals are organized into Technical Advisory Groups and work within a structured framework as part of a quality-controlled standards development process. Results The extensive involvement of international scientific and professional societies in the development of the standard has ensured that ISBT 128 has gained widespread recognition. The user community has developed confidence in the ability of the standard to adapt to new developments in their fields of interest. The standard is fully compatible with Single European Code requirements for tissues and cells and is utilized by many European tissue establishments. ISBT 128's flexibility and robustness has allowed for expansions into subject areas such as cellular therapy, regenerative medicine, and tissue banking. Conclusion ISBT 128 is the internationally recognized standard for coding MPHO and has gained widespread use globally throughout the past two decades. PMID:29344013

  17. 16 CFR 1615.5 - Labeling requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE.... (a) Care labels. All items of children's sleepwear shall be labeled with precautionary instructions... accordance with rules and regulations established by the Consumer Product Safety Commission. (b) [Reserved...

  18. Harmonisation of food labelling regulations in Southeast Asia: benefits, challenges and implications.

    PubMed

    Kasapila, William; Shaarani, Sharifudin Md

    2011-01-01

    In the globalised world of the 21st century, issues of food and nutrition labelling are of pre-eminent importance. Several international bodies, including the World Health Organisation and World Trade Organisation, are encouraging countries to harmonise their food and nutrition regulations with international standards, guidelines and recommendations such as those for Codex Alimentarius. Through harmonisation, these organisations envisage fewer barriers to trade and freer movement of food products between countries, which would open doors to new markets and opportunities for the food industry. In turn, increased food trade would enhance economic development and allow consumers a greater choice of products. Inevitably, however, embracing harmonisation brings along cost implications and challenges that have to be overcome. Moreover, the harmonisation process is complex and sporadic in light of the tasks that countries have to undertake; for example, updating legislation, strengthening administrative capabilities and establishing analytical laboratories. This review discusses the legislation and regulations that govern food and nutrition labelling in Southeast Asia, and highlights the discrepancies that exist in this regard, their origin and consequences. It also gives an account of the current status of harmonising labelling of pre-packaged foodstuffs in the region and explains the subsequent benefits, challenges and implications for governments, the food industry and consumers.

  19. [International Standards of Tuberculosis Care (ISTC)--comments from the German point of view].

    PubMed

    Castell, S; Bauer, T; Diel, R; Hedrich, A; Magdorf, K; Rüsch-Gerdes, S; Schaberg, T; Loddenkemper, R

    2012-04-01

    The "International Standards for Tuberculosis Care" (ISTC) were developed by the World Health Organisation (WHO) and others to provide internationally agreed and, if possible, evidence-based standards for tuberculosis care including the care by private providers who are not part of national tuberculosis programmes or health-care systems. Hence, the ISTC primarily address resource-restrained countries with high tuberculosis prevalence. In this article, the German translation of the 21 standards from 2009 is presented - addressing diagnostic and therapeutic standards, co-infection (especially with HIV) and public-health issues. The accompanying comments show how these standards have to be modified for Germany due to the medical resources available here and country-specific characteristics respectively. © Georg Thieme Verlag KG Stuttgart · New York.

  20. International standards for programmes of training in intensive care medicine in Europe.

    PubMed

    2011-03-01

    To develop internationally harmonised standards for programmes of training in intensive care medicine (ICM). Standards were developed by using consensus techniques. A nine-member nominal group of European intensive care experts developed a preliminary set of standards. These were revised and refined through a modified Delphi process involving 28 European national coordinators representing national training organisations using a combination of moderated discussion meetings, email, and a Web-based tool for determining the level of agreement with each proposed standard, and whether the standard could be achieved in the respondent's country. The nominal group developed an initial set of 52 possible standards which underwent four iterations to achieve maximal consensus. All national coordinators approved a final set of 29 standards in four domains: training centres, training programmes, selection of trainees, and trainers' profiles. Only three standards were considered immediately achievable by all countries, demonstrating a willingness to aspire to quality rather than merely setting a minimum level. Nine proposed standards which did not achieve full consensus were identified as potential candidates for future review. This preliminary set of clearly defined and agreed standards provides a transparent framework for assuring the quality of training programmes, and a foundation for international harmonisation and quality improvement of training in ICM.

  1. Oligonucleotide labeling methods. 3. Direct labeling of oligonucleotides employing a novel, non-nucleosidic, 2-aminobutyl-1,3-propanediol backbone.

    PubMed Central

    Nelson, P S; Kent, M; Muthini, S

    1992-01-01

    Novel CE-phosphoramidite (7a-e) and CPG (8a, c, d, e) reagents have been prepared from a unique 2-aminobutyl-1,3-propanediol backbone. The reagents have been used to directly label oligonucleotides with fluorescein, acridine, and biotin via automated DNA synthesis. The versatile 2-aminobutyl-1,3-propanediol backbone allows for labeling at any position (5', internal, and 3') during solid phase oligonucleotide synthesis. Multiple labels can be achieved by repetitive coupling cycles. Furthermore, the 3-carbon atom internucleotide phosphate distance is retained when inserted internally. Using this method, individual oligonucleotides possessing two and three different reporter molecules have been prepared. PMID:1475185

  2. 33 CFR 183.514 - Fuel tanks: Labels.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Fuel tanks: Labels. 183.514...) BOATING SAFETY BOATS AND ASSOCIATED EQUIPMENT Fuel Systems Equipment Standards § 183.514 Fuel tanks: Labels. (a) Each fuel tank must have a label that meets the requirements of paragraphs (b) through (d) of...

  3. 33 CFR 183.514 - Fuel tanks: Labels.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Fuel tanks: Labels. 183.514...) BOATING SAFETY BOATS AND ASSOCIATED EQUIPMENT Fuel Systems Equipment Standards § 183.514 Fuel tanks: Labels. (a) Each fuel tank must have a label that meets the requirements of paragraphs (b) through (d) of...

  4. 78 FR 8362 - Energy Labeling Rule

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-06

    ... FEDERAL TRADE COMMISSION 16 CFR Part 305 RIN 3084-AB15] Energy Labeling Rule AGENCY: Federal Trade... furnace or central air conditioner meets applicable Department of Energy regional efficiency standards..., 20580. SUPPLEMENTARY INFORMATION: I. Background The Commission's Energy Labeling Rule (``Rule'') (16 CFR...

  5. Doctors' confusion over ratios and percentages in drug solutions: the case for standard labelling

    PubMed Central

    Wheeler, Daniel Wren; Remoundos, Dionysios Dennis; Whittlestone, Kim David; Palmer, Michael Ian; Wheeler, Sarah Jane; Ringrose, Timothy Richard; Menon, David Krishna

    2004-01-01

    The different ways of expressing concentrations of drugs in solution, as ratios or percentages or mass per unit volume, are a potential cause of confusion that may contribute to dose errors. To assess doctors' understanding of what they signify, all active subscribers to doctors.net.uk, an online community exclusively for UK doctors, were invited to complete a brief web-based multiple-choice questionnaire that explored their familiarity with solutions of adrenaline (expressed as a ratio), lidocaine (expressed as a percentage) and atropine (expressed in mg per mL), and their ability to calculate the correct volume to administer in clinical scenarios relevant to all specialties. 2974 (24.6%) replied. The mean score achieved was 4.80 out of 6 (SD 1.38). Only 85.2% and 65.8% correctly identified the mass of drug in the adrenaline and lidocaine solutions, respectively, whilst 93.1% identified the correct concentration of atropine. More would have administered the correct volume of adrenaline and lidocaine in clinical scenarios (89.4% and 81.0%, respectively) but only 65.5% identified the correct volume of atropine. The labelling of drug solutions as ratios or percentages is antiquated and confusing. Labelling should be standardized to mass per unit volume. PMID:15286190

  6. [Comparative analysis of quality labels of health websites].

    PubMed

    Padilla-Garrido, N; Aguado-Correa, F; Huelva-López, L; Ortega-Moreno, M

    2016-01-01

    The search for health related information on the Internet is a growing phenomenon, buts its main drawback is the lack of reliability of information consulted. The aim of this study was to analyse and compare existing quality labels of health websites. A cross-sectional study was performed by searching Medline, IBECS, Google, and Yahoo, in both English and Spanish, between 8 and 9 March, 2015. Different keywords were used depending on whether the search was conducted in medical databases or generic search engines. The quality labels were classified according to their origin, analysing their character, year of implementation, the existence of the accreditation process, number of categories, criteria and standards, possibility of self-assessment, number of levels of certification, certification scope, validity, analytical quality of content, fee, results of the accreditation process, application and number of websites granted the seal, and quality labels obtained by the accrediting organisation. Seven quality labels, five of Spanish origin (WMA, PAWS, WIS, SEAFORMEC and M21) and two international ones (HONcode and Health Web Site Accreditation), were analysed. There was disparity in carrying out the accreditation process, with some not detailing key aspects of the process, or providing incomplete, outdated, or even inaccurate information. The most rigorous guaranteed the level of confidence that the websites had in relation to the content of information, but none checked the quality of them. Although rigorous quality labels may become useful, the deficiencies in some of them cast doubt on their current usefulness. Copyright © 2015 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  7. The protection of migrant workers and international labour standards.

    PubMed

    Bohning, W R

    1988-06-01

    International labor standards take the form of Conventions and Recommendations that embody the agreements reached by a 2/3 majority of the representatives of Governments, Employers, and Workers of International Labour Office (ILO) member states. Originally designed to guard against the danger that 1 country or other would keep down wages and working conditions to gain competitive advantage and thereby undermine advances elsewhere, international labor standards have also been inspired by humanitarian concerns--the visible plight of workers and the physical dangers of industrialization and by the notion of social justice, which embraces wellbeing and dignity, security, and equality as well as a measure of participation in economic and social matters. ILO standards apply to workers generally and therefore also to migrant workers, irrespective of the fact that the general standards are complemented by standards especially for migrant workers. The social security protection of migrant workers has been dealt with in ILO instruments primarily from the angle of equality of treatment but also from that of the maintenance of acquired rights and rights in course of acquisition, including the payment of benefits to entitled persons resident abroad. The ILO Conventions on migrant workers and the Recommendations which supplement them deal with practically all aspects of the work and life of non-nationals such as recruitment matters, information to be made available, contract conditions, medical examination and attention, customs, exemption for personal effects, assistance in settling into their new environment, vocational training, promotion at work, job security and alternative employment, liberty of movement, participation in the cultural life of the state as well as maintenance of their own culture, transfer of earnings and savings, family reunification and visits, appeal against unjustified termination of employment or expulsion, and return assistance. ILO's supervisory

  8. 77 FR 9859 - Lifesaving Equipment: Production Testing and Harmonization With International Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... inflatable buoyant apparatuses may be certified using either occupant weight standard. Likewise, equipment...-AB46 Lifesaving Equipment: Production Testing and Harmonization With International Standards AGENCY... lifesaving equipment to harmonize Coast Guard regulations for inflatable liferafts and inflatable buoyant...

  9. 40 CFR 1042.135 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... label. (e) For engines requiring ULSD, create a separate label with the statement: “ULTRA LOW SULFUR... power (in kW), and power density (in kW/L) as needed to determine the emission standards for the engine family. You may specify displacement, maximum engine power, or power density as a range consistent with...

  10. Do Australian immunoglobulin products meet international measles antibody titer standards?

    PubMed

    Young, Megan K; Bertolini, Joseph; Kotharu, Pushpa; Maher, Darryl; Cripps, Allan W

    2017-03-04

    The effectiveness of passive immunisation post-exposure to measles appears subject to a dose-response effect. New Zealand and the United Kingdom have increased the recommended dose of polyclonal human immunoglobulin for post-exposure prophylaxis within the last decade in response to concerns about decreasing levels of measles antibodies in these products. This study used the plaque-reduction neutralization test (PRNT) to measure the titer of measles-specific antibodies in Australian immunoglobulin products for post-exposure prophylaxis and compared the utility of an enzyme-linked immunosorbent assay (ELISA) to the PRNT in available Australian and international samples: Australian intramuscular (n = 10), Australian intravenous (n = 28), New Zealand intramuscular (n = 2), Hizentra (subcutaneous)(USA) (n = 3), and Privigen (intravenous)(USA) (n = 2). Measles titres in Australian IM and IV immunoglobulins ranged from 51 to 76 IU/mL and 6 to 24 IU/mL respectively, as measured by PRNT calibrated to the WHO 3 rd international standard. ELISA titres were variable but higher than PRNT titres in all tested samples. Measles antibody titres in Australian immunoglobulin products meet consensus-prescribed international thresholds. Development of a convenient, standardized, readily accessible assay for determination of measles titres in immunoglobulin products would be useful for future studies and facilitate international comparisons.

  11. The internal consistency of the standard gamble: tests after adjusting for prospect theory.

    PubMed

    Oliver, Adam

    2003-07-01

    This article reports a study that tests whether the internal consistency of the standard gamble can be improved upon by incorporating loss weighting and probability transformation parameters in the standard gamble valuation procedure. Five alternatives to the standard EU formulation are considered: (1) probability transformation within an EU framework; and, within a prospect theory framework, (2) loss weighting and full probability transformation, (3) no loss weighting and full probability transformation, (4) loss weighting and no probability transformation, and (5) loss weighting and partial probability transformation. Of the five alternatives, only the prospect theory formulation with loss weighting and no probability transformation offers an improvement in internal consistency over the standard EU valuation procedure.

  12. Constructing Uniformity: the Standardization of International Electromagnetic Measures, 1860-1912

    NASA Astrophysics Data System (ADS)

    Lagerstrom, Larry Randles

    Metrology gained much attention from electrical scientists and practitioners in the nineteenth and early twentieth centuries. Spurred by the expanding telegraph industries, they considered the construction and acceptance of a universal system of electromagnetic measures essential for the growth of science and technology. The task was not easy. Scientists and practitioners, having different concerns and needs, often found themselves at odds. National rivalries further obstructed the attainment of uniform measures. Under the auspices of a series of international electrical congresses and conferences between 1881 and 1908, the systembuilders succeeded in establishing an international system of practical electrical units and standards--the ohm, volt, ampere, coulomb, farad, joule, and watt--based on the centimeter-gram-second (CGS) system of measures. They had less success, however, with practical magnetic units. They had designed the system of electrical units to meet the needs of telegraphy. But the rise of the technologies of electrical power in the late nineteenth century made it difficult to define magnetic units that were both practical for the new technologies and coherent with the existing system of units. The international congress, as an institution, also gave them trouble. It lacked authority and stability and, in some cases, hindered the development of the system of units. More credit for the success of the systembuilders must go, paradoxically, to the national physical laboratories that arose in Germany, France, Great Britain, and the United States circa 1900. They enabled the standardization of international electromagnetic measures by narrowing the community of systembuilders to a small circle of elite experts. This historical process illustrates important aspects of the ways and means of standardization, of the technical and social construction of uniformity.

  13. 78 FR 987 - Hazardous Materials: Harmonization with International Standards (RRR)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ...PHMSA is amending the Hazardous Materials Regulations to maintain alignment with international standards by incorporating various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. These revisions are necessary to harmonize the Hazardous Materials Regulations (HMR) with recent changes made to the International Maritime Dangerous Goods (IMDG) Code, the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions), and the United Nations Recommendations on the Transport of Dangerous Goods--Model Regulations (UN Model Regulations) and address a petition for rulemaking.

  14. 77 FR 49167 - Hazardous Materials: Harmonization with International Standards (RRR)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

    ...PHMSA proposes to amend the Hazardous Materials Regulations to maintain alignment with international standards by incorporating various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. These revisions are necessary to harmonize the Hazardous Materials Regulations with recent changes made to the International Maritime Dangerous Goods Code, the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air, and the United Nations Recommendations on the Transport of Dangerous Goods--Model Regulations and subsequently address a petition for rulemaking.

  15. Assessment of opacimeter calibration according to International Standard Organization 10155.

    PubMed

    Gomes, J F

    2001-01-01

    This paper compares the calibration method for opacimeters issued by the International Standard Organization (ISO) 10155 with the manual reference method for determination of dust content in stack gases. ISO 10155 requires at least nine operational measurements, corresponding to three operational measurements per each dust emission range within the stack. The procedure is assessed by comparison with previous calibration methods for opacimeters using only two operational measurements from a set of measurements made at stacks from pulp mills. The results show that even if the international standard for opacimeter calibration requires that the calibration curve is to be obtained using 3 x 3 points, a calibration curve derived using 3 points could be, at times, acceptable in statistical terms, provided that the amplitude of individual measurements is low.

  16. Profiling structured product labeling with NDF-RT and RxNorm

    PubMed Central

    2012-01-01

    Background Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by United States Food and Drug Administration (FDA) as a mechanism for exchanging drug product information. The SPL drug labels contain rich information about FDA approved clinical drugs. However, the lack of linkage to standard drug ontologies hinders their meaningful use. NDF-RT (National Drug File Reference Terminology) and NLM RxNorm as standard drug ontology were used to standardize and profile the product labels. Methods In this paper, we present a framework that intends to map SPL drug labels with existing drug ontologies: NDF-RT and RxNorm. We also applied existing categorical annotations from the drug ontologies to classify SPL drug labels into corresponding classes. We established the classification and relevant linkage for SPL drug labels using the following three approaches. First, we retrieved NDF-RT categorical information from the External Pharmacologic Class (EPC) indexing SPLs. Second, we used the RxNorm and NDF-RT mappings to classify and link SPLs with NDF-RT categories. Third, we profiled SPLs using RxNorm term type information. In the implementation process, we employed a Semantic Web technology framework, in which we stored the data sets from NDF-RT and SPLs into a RDF triple store, and executed SPARQL queries to retrieve data from customized SPARQL endpoints. Meanwhile, we imported RxNorm data into MySQL relational database. Results In total, 96.0% SPL drug labels were mapped with NDF-RT categories whereas 97.0% SPL drug labels are linked to RxNorm codes. We found that the majority of SPL drug labels are mapped to chemical ingredient concepts in both drug ontologies whereas a relatively small portion of SPL drug labels are mapped to clinical drug concepts. Conclusions The profiling outcomes produced by this study would provide useful insights on meaningful use of FDA SPL drug labels in clinical applications through

  17. Profiling structured product labeling with NDF-RT and RxNorm.

    PubMed

    Zhu, Qian; Jiang, Guoqian; Chute, Christopher G

    2012-12-20

    Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by United States Food and Drug Administration (FDA) as a mechanism for exchanging drug product information. The SPL drug labels contain rich information about FDA approved clinical drugs. However, the lack of linkage to standard drug ontologies hinders their meaningful use. NDF-RT (National Drug File Reference Terminology) and NLM RxNorm as standard drug ontology were used to standardize and profile the product labels. In this paper, we present a framework that intends to map SPL drug labels with existing drug ontologies: NDF-RT and RxNorm. We also applied existing categorical annotations from the drug ontologies to classify SPL drug labels into corresponding classes. We established the classification and relevant linkage for SPL drug labels using the following three approaches. First, we retrieved NDF-RT categorical information from the External Pharmacologic Class (EPC) indexing SPLs. Second, we used the RxNorm and NDF-RT mappings to classify and link SPLs with NDF-RT categories. Third, we profiled SPLs using RxNorm term type information. In the implementation process, we employed a Semantic Web technology framework, in which we stored the data sets from NDF-RT and SPLs into a RDF triple store, and executed SPARQL queries to retrieve data from customized SPARQL endpoints. Meanwhile, we imported RxNorm data into MySQL relational database. In total, 96.0% SPL drug labels were mapped with NDF-RT categories whereas 97.0% SPL drug labels are linked to RxNorm codes. We found that the majority of SPL drug labels are mapped to chemical ingredient concepts in both drug ontologies whereas a relatively small portion of SPL drug labels are mapped to clinical drug concepts. The profiling outcomes produced by this study would provide useful insights on meaningful use of FDA SPL drug labels in clinical applications through standard drug ontologies such as NDF-RT and

  18. 7 CFR 65.400 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) COUNTRY OF ORIGIN LABELING...

  19. 21 CFR 640.70 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.70 Labeling. Link to an amendment published... information shall appear on the label affixed to each container of Source Plasma: (1) The proper name of the... shall follow the proper name in the same size and type of print as the proper name. If the Source Plasma...

  20. Comparison of FRA regulations to international high-speed rail standards.

    DOT National Transportation Integrated Search

    2013-05-01

    This report compares international standards with selected parts of Federal Railroad Administration (FRA) Code of Federal Regulation Title 49 CFR Transportation. The parts were preselected by FRA and are meant to reflect those areas of the regulation...

  1. How Two Small Pharmacy Schools' Competency Standards Compare with an International Competency Framework and How Well These Schools Prepare Students for International Placements.

    PubMed

    Hawboldt, John; Nash, Rose; FitzPatrick, Beverly

    2017-03-06

    International standards of pharmacy curricula are necessary to ensure student readiness for international placements. This paper explores whether curricula from two pharmacy programs, in Australia and Canada, are congruent with international standards and if students feel prepared for international placements. Nationally prescribed educational standards for the two schools were compared to each other and then against the International Pharmaceutical Federation (FIP) Global Competency Framework. Written student reflections complemented this analysis. Mapping results suggested substantial agreement between the FIP framework and Australia and Canada, with two gaps being identified. Moreover, the students felt their programs prepared them for their international placements. Despite differences in countries, pharmacy programs, and health-systems all students acclimatized to their new practice sites. Implications are that if pharmacy programs align well with FIP, pharmacists should be able to integrate and practise in other jurisdictions that also align with the FIP. This has implications for the mobility of pharmacy practitioners to countries not of their origin of training.

  2. The legibility of prescription medication labelling in Canada

    PubMed Central

    Ahrens, Kristina; Krishnamoorthy, Abinaya; Gold, Deborah; Rojas-Fernandez, Carlos H.

    2014-01-01

    Introduction: The legibility of medication labelling is a concern for all Canadians, because poor or illegible labelling may lead to miscommunication of medication information and poor patient outcomes. There are currently few guidelines and no regulations regarding print standards on medication labels. This study analyzed sample prescription labels from Ontario, Canada, and compared them with print legibility guidelines (both generic and specific to medication labels). Methods: Cluster sampling was used to randomly select a total of 45 pharmacies in the tri-cities of Kitchener, Waterloo and Cambridge. Pharmacies were asked to supply a regular label with a hypothetical prescription. The print characteristics of patient-critical information were compared against the recommendations for prescription labels by pharmaceutical and health organizations and for print accessibility by nongovernmental organizations. Results: More than 90% of labels followed the guidelines for font style, contrast, print colour and nonglossy paper. However, only 44% of the medication instructions met the minimum guideline of 12-point print size, and none of the drug or patient names met this standard. Only 5% of the labels were judged to make the best use of space, and 51% used left alignment. None of the instructions were in sentence case, as is recommended. Discussion: We found discrepancies between guidelines and current labels in print size, justification, spacing and methods of emphasis. Conclusion: Improvements in pharmacy labelling are possible without moving to new technologies or changing the size of labels and would be expected to enhance patient outcomes. PMID:24847371

  3. An in-advance stable isotope labeling strategy for relative analysis of multiple acidic plant hormones in sub-milligram Arabidopsis thaliana seedling and a single seed.

    PubMed

    Sun, Xiaohong; Ouyang, Yue; Chu, Jinfang; Yan, Jing; Yu, Yan; Li, Xiaoqiang; Yang, Jun; Yan, Cunyu

    2014-04-18

    A sensitive and reliable in-advance stable isotope labeling strategy was developed for simultaneous relative quantification of 8 acidic plant hormones in sub-milligram amount of plant materials. Bromocholine bromide (BETA) and its deuterated counterpart D9-BETA were used to in-advance derivatize control and sample extracts individually, which were then combined and subjected to solid-phase extraction (SPE) purification followed by UPLC-MS/MS analysis. Relative quantification of target compounds was obtained by calculation of the peak area ratios of BETA/D9-BETA labeled plant hormones. The in-advance stable isotope labeling strategy realized internal standard-based relative quantification of multiple kinds of plant hormones independent of availability of internal standard of every analyte with enhanced sensitivity of 1-3 orders of magnitude. Meanwhile, the in-advance labeling contributes to higher sample throughput and more reliability. The method was successfully applied to determine 8 plant hormones in 0.8mg DW (dry weight) of seedlings and 4 plant hormones from single seed of Arabidopsis thaliana. The results show the potential of the method in relative quantification of multiple plant hormones in tiny plant tissues or organs, which will advance the knowledge of the crosstalk mechanism of plant hormones. Copyright © 2014 Elsevier B.V. All rights reserved.

  4. Combustion method for assay of biological materials labeled with carbon-14 or tritium, or double-labeled

    NASA Technical Reports Server (NTRS)

    Huebner, L. G.; Kisieleski, W. E.

    1969-01-01

    Dry catalytic combustion at high temperatures is used for assaying biological materials labeled carbon-14 and tritium, or double-labeled. A modified oxygen-flask technique is combined with standard vacuum-line techniques and includes convenience of direct in-vial collection of final combustion products, giving quantitative recovery of tritium and carbon-14.

  5. Naming, labeling, and packaging of pharmaceuticals.

    PubMed

    Kenagy, J W; Stein, G C

    2001-11-01

    The problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals is discussed. Sound-alike and look-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient injury or death. The existing medication-use system is flawed because its safety depends on human perfection. Simplicity, standardization, differentiation, lack of duplication, and unambiguous communication are human factors concepts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, current methods are based on long-standing commercial considerations and bureaucratic procedures. The process for naming a marketable drug is lengthy and complex and involves submission of a new chemical entity and patent application, generic naming, brand naming, FDA review, and final approval. Drug companies seek the fastest possible approval and may believe that the incremental benefit of human factors evaluation is small. "Trade dress" is the concept that underlies labeling and packaging issues for the drug industry. Drug companies are resistant to changing trade dress and brand names. Although a variety of private-sector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem remains. Drug names, labels, and packages are not selected and designed in accordance with human factors principles. FDA standards do not require application of these principles, the drug industry has struggled with change, and private-sector initiatives have had only limited success.

  6. Progress towards Managing Residential Electricity Demand: Impacts of Standards and Labeling for Refrigerators and Air Conditioners in India

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

    McNeil, Michael A.; Iyer, Maithili

    The development of Energy Efficiency Standards and Labeling (EES&L) began in earnest in India in 2001 with the Energy Conservation Act and the establishment of the Indian Bureau of Energy Efficiency (BEE). The first main residential appliance to be targeted was refrigerators, soon to be followed by room air conditioners. Both of these appliances are of critical importance to India's residential electricity demand. About 15percent of Indian households own a refrigerator, and sales total about 4 million per year, but are growing. At the same time, the Indian refrigerator market has seen a strong trend towards larger and more consumptivemore » frost-free units. Room air conditioners in India have traditionally been sold to commercial sector customers, but an increasing number are going to the residential sector. Room air conditioner sales growth in India peaked in the last few years at 20percent per year. In this paper, we perform an engineering-based analysis using data specific to Indian appliances. We evaluate costs and benefits to residential and commercial sector consumers from increased equipment costs and utility bill savings. The analysis finds that, while the BEE scheme presents net benefits to consumers, there remain opportunities for efficiency improvement that would optimize consumer benefits, according to Life Cycle Cost analysis. Due to the large and growing market for refrigerators and air conditioners in India, we forecast large impacts from the standards and labeling program as scheduled. By 2030, this program, if fully implemented would reduce Indian residential electricity consumption by 55 TWh. Overall savings through 2030 totals 385 TWh. Finally, while efficiency levels have been set for several years for refrigerators, labels and MEPS for these products remain voluntary. We therefore consider the negative impact of this delay of implementation to energy and financial savings achievable by 2030.« less

  7. Report of the Task Force on Testing Standards (TFTS) to the International Language Testing Association (ILTA).

    ERIC Educational Resources Information Center

    International Language Testing Association.

    The Task Force on Testing Standards (TFTS) of the International Language Testing Association was charged to produce a report of an international survey of language assessment standards, to provide for exchange of information on standards and for development of a code of practice. Contact with individuals in both language testing and the broader…

  8. Assay of potency of the proposed Fifth International Standard for Gas-Gangrene Antitoxin (Perfringens)

    PubMed Central

    Prigge, R.; Micke, H.; Krüger, J.

    1963-01-01

    As part of a collaborative assay of the proposed Fifth International Standard for Gas-Gangrene Antitoxin (Perfringens), five ampoules of the proposed replacement material were assayed in the authors' laboratory against the then current Fourth International Standard. Both in vitro and in vivo methods were used. This paper presents the results and their statistical analysis. The two methods yielded different results which were not likely to have been due to chance, but exact statistical comparison is not possible. It is thought, however, that the differences may be due, at least in part, to differences in the relative proportions of zeta-antitoxin and alpha-antitoxin in the Fourth and Fifth International Standards and the consequent different reactions with the test toxin that was used for titration. PMID:14107746

  9. International Cooperation for a Single World Production Standard of High Definition Television.

    ERIC Educational Resources Information Center

    Hongcharu, Boonchai

    Broadcasters, television engineers and the production industry have encountered many problems with diverse television standards since the introduction of color television. With the advent of high definition television (HDTV), the chance to have a common production standard for international exchange of programs and technical information has…

  10. Do nutrition labels improve dietary outcomes?

    PubMed

    Variyam, Jayachandran N

    2008-06-01

    The disclosure of nutritional characteristics of most packaged foods became mandatory in the United States with the implementation of the Nutrition Labeling and Education Act (NLEA) in 1994. Under the NLEA regulations, a 'Nutrition Facts' panel displays information on nutrients such as calories, total and saturated fats, cholesterol, and sodium in a standardized format. By providing nutrition information in a credible, distinctive, and easy-to-read format, the new label was expected to help consumers choose healthier, more nutritious diets. This paper examines whether the disclosure of nutrition information through the mandatory labels impacted consumer diets. Assessing the dietary effects of labeling is problematic due to the confounding of the label effect with unobserved label user characteristics. This self-selection problem is addressed by exploiting the fact that the NLEA exempts away-from-home foods from mandatory labeling. Difference-in-differences models that account for zero away-from-home intakes suggest that the labels increase fiber and iron intakes of label users compared with label nonusers. In comparison, a model that does not account for self-selection implies significant label effects for all but two of the 13 nutrients that are listed on the label.

  11. Determination of chemical purity and isotopic composition of natural and carbon-13-labeled arsenobetaine bromide standards by quantitative(1)H-NMR.

    PubMed

    Le, Phuong-Mai; Ding, Jianfu; Leek, Donald M; Mester, Zoltan; Robertson, Gilles; Windust, Anthony; Meija, Juris

    2016-10-01

    In this study, we report the characterization of three arsenobetaine-certified reference materials by quantitative NMR. We have synthesized an arsenobetaine bromide high-purity standard of natural isotopic composition (ABET-1) and two carbon-13-labeled isotopic standards (BBET-1 and CBET-1). Assignments of the chemical purity and isotopic composition are not trivial in the case of arsenobetaine, and in this study we utilized quantitative(1)H-NMR techniques for the determination of the mass fractions (chemical purity). The isotopic purity of all three standards was also assessed by NMR from the carbon-13 satellite signals. The standards are non-hygroscopic, high-purity (ca. 0.99 g/g), and the carbon-13 enrichment for both isotopic standards is x((13)C)≈0.99. These standards are designed for use as primary calibrators for mass spectrometric determination of arsenobetaine in environmental samples.

  12. DEVELOPMENT OF INTERNATIONAL STANDARDS FOR AIR QUALITY MONITORING AND CONTROL

    EPA Science Inventory

    This report presents a description of the activities and accomplishments of the American Society for Testing and Materials' U. S. Technical Advisory Group (TAG) to the International Standards Organization's Technical Committee 146 on Air Quality. The purpose of the TAG is to re...

  13. 25 CFR 543.23 - What are the minimum internal control standards for audit and accounting?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... supervision, bingo cards, bingo card sales, draw, prize payout; cash and equivalent controls, technologic aids... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for audit... INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.23 What are the...

  14. 25 CFR 543.23 - What are the minimum internal control standards for audit and accounting?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... supervision, bingo cards, bingo card sales, draw, prize payout; cash and equivalent controls, technologic aids... 25 Indians 2 2013-04-01 2013-04-01 false What are the minimum internal control standards for audit... INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.23 What are the...

  15. Nutrition labelling is a trade policy issue: lessons from an analysis of specific trade concerns at the World Trade Organization.

    PubMed

    Thow, Anne Marie; Jones, Alexandra; Hawkes, Corinna; Ali, Iqra; Labonté, Ronald

    2017-01-12

    Interpretive nutrition labels provide simplified nutrient-specific text and/or symbols on the front of pre-packaged foods, to encourage and enable consumers to make healthier choices. This type of labelling has been proposed as part of a comprehensive policy response to the global epidemic of non-communicable diseases. However, regulation of nutrition labelling falls under the remit of not just the health sector but also trade. Specific Trade Concerns have been raised at the World Trade Organization's Technical Barriers to Trade Committee regarding interpretive nutrition labelling initiatives in Thailand, Chile, Indonesia, Peru and Ecuador. This paper presents an analysis of the discussions of these concerns. Although nutrition labelling was identified as a legitimate policy objective, queries were raised regarding the justification of the specific labelling measures proposed, and the scientific evidence for effectiveness of such measures. Concerns were also raised regarding the consistency of the measures with international standards. Drawing on policy learning theory, we identified four lessons for public health policy makers, including: strategic framing of nutrition labelling policy objectives; pro-active policy engagement between trade and health to identify potential trade issues; identifying ways to minimize potential 'practical' trade concerns; and engagement with the Codex Alimentarius Commission to develop international guidance on interpretative labelling. This analysis indicates that while there is potential for trade sector concerns to stifle innovation in nutrition labelling policy, care in how interpretive nutrition labelling measures are crafted in light of trade commitments can minimize such a risk and help ensure that trade policy is coherent with nutrition action. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  16. 40 CFR 1037.135 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 34 2012-07-01 2012-07-01 false Labeling. 1037.135 Section 1037.135 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF... identify other emission standards that the vehicle meets or does not meet (such as European standards). You...

  17. 40 CFR 1037.135 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 34 2013-07-01 2013-07-01 false Labeling. 1037.135 Section 1037.135 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF... identify other emission standards that the vehicle meets or does not meet (such as European standards). You...

  18. Collaborative study for the establishment of the 4(th) International Standard for Streptomycin.

    PubMed

    Jorajuria, S; Raphalen, C; Dujardin, V; Daas, A

    2015-01-01

    An international collaborative study was organised to establish the 4(th) World Health Organization (WHO) International Standard (IS) for Streptomycin. Fourteen laboratories from different countries participated. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organisms. To ensure continuity between consecutive batches, the 3(rd) IS for Streptomycin was used as a reference. Based on the results of the study, the 4(th) IS for Streptomycin was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2015 with an assigned potency of 76 000 International Units (IU) per vial. The 4(th) IS for Streptomycin is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).

  19. Commercial versus Internally Developed Standardized Tests: Lessons from a Small Regional School

    ERIC Educational Resources Information Center

    Hadjicharalambous, Costas

    2014-01-01

    The author compares the efficacy of commercially available and internally developed standardized tests and evaluates their strengths and weakness in assessing student learning outcomes. The author shares the experience of a regional school in developing a standardized test to assess business knowledge. Data from a sample of 268 students were used…

  20. 78 FR 23508 - Use of Certain Symbols in Labeling

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    ... English language* * *'' (Sec. 801.15(c)(1)). The regulation goes on to allow for use of foreign language... 809 [Docket No. FDA-2013-N-0125] RIN 0910-AG74 Use of Certain Symbols in Labeling AGENCY: Food and... standardized symbol is part of a standard recognized by FDA for use on the labeling of medical devices (or on a...

  1. Problems of the development of international standards of “green building” in Russia

    NASA Astrophysics Data System (ADS)

    Meshcheryakova, Tatiana

    2017-10-01

    Problems of environmental friendliness and energy efficiency in recent decades have become not only the most important issues of economic development of the main industrial economies, but also the basis for the processes of maintaining the security and relative stability of the global ecosystem. The article presents the results of the study of the status and trends of the development of environmental standards for the construction and maintenance of real estate in the world and particularly in Russia. Special market instruments for assessing the compliance with the quality of real estate projects under construction and modern principles of environmental friendliness and energy efficiency include voluntary building certification systems that are actively used in international practice. In Russia there is active use of the following international systems of certification: BREEAM, LEED, DGNB, HQE. Also in the Russian certification market, the national standard STO NOSTROY 2.35.4-2011 “Residential and public buildings” is being implemented, which summarizes the best international experience of the rating evaluation procedure. Comparative characteristics of the “green” standards and the principles of rating assessments of the ecological compatibility of buildings give an idea of applying these standards in Russia.

  2. 76 FR 65166 - International Sanitary and Phytosanitary Standard-Setting Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-20

    ..., formerly known as the Office International des Epizooties) regarding animal health and welfare, and... bulletins on global disease status, and provides animal disease control guidelines to Members. Various OIE commissions and working groups undertake the development and preparation of draft standards, which are then...

  3. What's in a Name? a Theoretical Exploration of the Proliferation of Labels for International Education across the Higher Education Sector

    ERIC Educational Resources Information Center

    Whitsed, Craig; Green, Wendy

    2014-01-01

    Across the higher education sector international education has been described as experiencing a "crisis of identity." The recent proliferation of new terms advanced to label "internationalization," it has been suggested, represents little more than "tautology." Here, we address questions posed by de Wit regarding this…

  4. Saturation Fluorescence Labeling of Proteins for Proteomic Analyses

    PubMed Central

    Pretzer, Elizabeth; Wiktorowicz, John E.

    2008-01-01

    We present here an optimized and cost-effective approach to saturation fluorescence labeling of protein thiols for proteomic analysis. We investigated a number of conditions and reagent concentrations including a disulfide reducing agent (TCEP), pH, incubation time, linearity of labeling, and saturating dye: protein thiol ratio with protein standards to gauge specific and non-specific labeling. Efficacy of labeling under these conditions was quantified using specific fluorescence estimation, defined as the ratio of fluorescence pixel intensities and Coomassie-stained pixel intensities of bands after digital imaging. Factors leading to specific vs. non-specific labeling in the presence of thiourea are also discussed. We have found that reproducible saturation of available Cys residues of the proteins used as labeling standards (human carbonic anhydrase I, enolase, α-lactalbumin) is achieved at 50-100-fold excess of the uncharged maleimide-functionalized BODIPY™ dyes over Cys. We confirm our previous findings and those of others that the maleimide dyes are not impacted by the presence of 2M thiourea. Moreover, we establish that 2 mM TCEP used as reductant is optimal. We also establish further that labeling is optimal at pH 7.5 and complete after 30 min. Low non-specific labeling was gauged by the inclusion of non-Cys containing proteins (horse myoglobin, bovine carbonic anhydrase) to the labeling mixture. We also show that the dye exhibits little to no effect on the two dimensional mobilities of labeled proteins derived from cells. PMID:18191033

  5. Assessing the properties of internal standards for quantitative matrix-assisted laser desorption/ionization mass spectrometry of small molecules.

    PubMed

    Sleno, Lekha; Volmer, Dietrich A

    2006-01-01

    Growing interest in the ability to conduct quantitative assays for small molecules by matrix-assisted laser desorption/ionization (MALDI) has been the driving force for several recent studies. This present work includes the investigation of internal standards for these analyses using a high-repetition rate MALDI triple quadrupole instrument. Certain physicochemical properties are assessed for predicting possible matches for internal standards for different small molecules. The importance of similar molecular weight of an internal standard to its analyte is seen through experiments with a series of acylcarnitines, having a fixed charge site and growing alkyl chain length. Both acetyl- and hexanoyl-carnitine were systematically assessed with several other acylcarnitine compounds as internal standards. The results clearly demonstrate that closely matched molecular weights between analyte and internal standard are essential for acceptable quantitation results. Using alpha-cyano-4-hydroxycinnamic acid as the organic matrix, the similarities between analyte and internal standard remain the most important parameter and not necessarily their even distribution within the solid sample spot. Several 4-quinolone antibiotics as well as a diverse group of pharmaceutical drugs were tested as internal standards for the 4-quinolone, ciprofloxacin. Quantitative results were shown using the solution-phase properties, log D and pKa, of these molecules. Their distribution coefficients, log D, are demonstrated as a fundamental parameter for similar crystallization patterns of analyte and internal standard. In the end, it was also possible to quantify ciprofloxacin using a drug from a different compound class, namely quinidine, having a similar log D value as the analyte. Copyright 2006 John Wiley & Sons, Ltd.

  6. Development and testing of a new disposable sterile device for labelling white blood cells.

    PubMed

    Signore, A; Glaudemans, A W J M; Malviya, G; Lazzeri, E; Prandini, N; Viglietti, A L; De Vries, E F J; Dierckx, R A J O

    2012-08-01

    White blood cell (WBC) labelling requires isolation of cells from patient's blood under sterile conditions using sterile materials, buffers and disposables under good manufacturing practice (GMP) conditions. Till now, this limited the use of white blood cell scintigraphy (WBC-S) only to well equipped laboratories with trained personnel. We invented, developed and tested a disposable, sterile, closed device for blood manipulation, WBC purification and radionuclide labelling without exposing patient's blood and the operator to contamination risks. This device prototype and a final industrialized device (Leukokit®) were tested for WBC labelling and compared to standard procedure. Leukokit® was also tested in an international multi-centre study for easiness of WBC purification and labelling. On the device prototype we tested in parallel, with blood samples from 7 volunteers, the labelling procedure compared to the standard procedure of the International Society of Radiolabeled Blood Elements (ISORBE) consensus protocol with respect to cell recovery, labelling efficiency (LE), cell viability (Trypan Blue test) and sterility (haemoculture). On the final Leukokit® we tested the biocompatibility of all components, and again the LE, erythro-sedimentation rate, cell viability, sterility and apyrogenicity. ACD-A, HES and PBS provided by Leukokit® were also compared to Heparin, Dextran and autologous plasma, respectively. In 4 samples, we tested the chemotactic activity of purified WBC against 1 mg/ml of lipopolysaccharide (LPS) and chemotaxis of 99mTc-HMPAO-labelled WBC (925 MBq) was compared to that of unlabelled cells. For the multi-centre study, 70 labellings were performed with the Leukokit® by 9 expert operators and 3 beginners from five centers using blood from both patients and volunteers. Finally, Media-Fill tests were performed by 3 operators on two different days (11 procedures) by replacing blood and kit reagents with bacterial culture media (Tryptic Soy Broth

  7. [Cross-Mapping: diagnostic labels formulated according to the ICNP® versus diagnosis of NANDA International].

    PubMed

    Tannure, Meire Chucre; Salgado, Patrícia de Oliveira; Chianca, Tânia Couto Machado

    2014-01-01

    This descriptive study aimed at elaborating nursing diagnostic labels according to ICNP®; conducting a cross-mapping between the diagnostic formulations and the diagnostic labels of NANDA-I; identifying the diagnostic labels thus obtained that were also listed in the NANDA-I; and mapping them according to Basic Human Needs. The workshop technique was applied to 32 intensive care nurses, the cross-mapping and validation based on agreement with experts. The workshop produced 1665 diagnostic labels which were further refined into 120 labels. They were then submitted to a cross-mapping process with both NANDA-I diagnostic labels and the Basic Human Needs. The mapping results underwent content validation by two expert nurses leading to concordance rates of 92% and 100%. It was found that 63 labels were listed in NANDA-I and 47 were not.

  8. Updating the International Standards for Tuberculosis Care. Entering the era of molecular diagnostics.

    PubMed

    Hopewell, Philip C; Fair, Elizabeth L; Uplekar, Mukund

    2014-03-01

    The International Standards for Tuberculosis Care, first published in 2006 (Lancet Infect Dis 2006;6:710-725.) with a second edition in 2009 ( www.currytbcenter.ucsf.edu/international/istc_report ), was produced by an international coalition of organizations funded by the United States Agency for International Development. Development of the document was led jointly by the World Health Organization and the American Thoracic Society, with the aim of promoting engagement of all care providers, especially those in the private sector in low- and middle-income countries, in delivering high-quality services for tuberculosis. In keeping with World Health Organization recommendations regarding rapid molecular testing, as well as other pertinent new recommendations, the third edition of the Standards has been developed. After decades of dormancy, the technology available for tuberculosis care and control is now rapidly evolving. In particular, rapid molecular testing, using devices with excellent performance characteristics for detecting Mycobacterium tuberculosis and rifampin resistance, and that are practical and affordable for use in decentralized facilities in low-resource settings, is being widely deployed globally. Used appropriately, both within tuberculosis control programs and in private laboratories, these devices have the potential to revolutionize tuberculosis care and control, providing a confirmed diagnosis and a determination of rifampin resistance within a few hours, enabling appropriate treatment to be initiated promptly. Major changes have been made in the standards for diagnosis. Additional important changes include: emphasis on the recognition of groups at increased risk of tuberculosis; updating the standard on antiretroviral treatment in persons with tuberculosis and human immunodeficiency virus infection; and revising the standard on treating multiple drug-resistant tuberculosis.

  9. 78 FR 8431 - Hazardous Materials: Harmonization with International Standards (RRR)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-06

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part 172 [Docket Nos. PHMSA-2012-0027 (HM-215L)] RIN 2137-AE87 Hazardous Materials: Harmonization with International Standards (RRR) Correction In rule document 2012-31243 appearing on pages 988 through 1100 in the...

  10. The role of international standards in managing business risks

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

    Mazza, S.

    1996-08-01

    Strategic standardization is an emerging management discipline which is gaining a slow but upward acceptance by many American business leaders. It is a management discipline widely followed by European business managers for a long time to ensure a strong competitive position in the global marketplace. American businesses are increasingly adapting this concept for effective management to open new markets, increase sales, reduce trade barriers, and ensure a competitive position both domestically as well as the international arena. Contrary to the view that standardization is only a technical strategy, there is a new reality that standardization is a critical business issuemore » with implications for market access, anti-trust, product liability, patent policy and protection, occupational, health safety, environmental management, government acquisition reform, and even our quality of life. It is often stated, standards are like the air we breathe always accepted and taken for granted until there is a problem of supply or in the case of standards, when they are used as a trade barrier or competitive advantage for others or used to create substantial liabilities for businesses and for individuals.« less

  11. Human factors in labeling and training for home healthcare technology.

    PubMed

    Patterson, Patricia A

    2010-01-01

    In this article, Patricia A. Patterson, a contributor to the recently-released standard ANSI/AAMI HE75:2009 Human factors engineering-Design of medical devices, highlights information from the standard important to developing labeling and training for homecare devices. She also describes one approach to developing labeling and training materials.

  12. The international growth standard for preadolescent and adolescent children: statistical considerations.

    PubMed

    Cole, T J

    2006-12-01

    This article discusses statistical considerations for the design of a new study intended to provide an International Growth Standard for Preadolescent and Adolescent Children, including issues such as cross-sectional, longitudinal, and mixed designs; sample-size derivation for the number of populations and number of children per population; modeling of growth centiles of height, weight, and other measurements; and modeling of the adolescent growth spurt. The conclusions are that a mixed longitudinal design will provide information on both growth distance and velocity; samples of children from 5 to 10 sites should be suitable for an international standard (based on political rather than statistical arguments); the samples should be broadly uniform across age but oversampled during puberty, and should include data into adulthood. The LMS method is recommended for constructing measurement centiles, and parametric or semiparametric approaches are available to estimate the timing of the adolescent growth spurt in individuals. If the new standard is to be grafted onto the 2006 World Health Organization (WHO) reference, caution is needed at the join point of 5 years, where children from the new standard are likely to be appreciably more obese than those from the WHO reference, due to the rising trends in obesity and the time gap in data collection between the two surveys.

  13. Multiplicative effects model with internal standard in mobile phase for quantitative liquid chromatography-mass spectrometry.

    PubMed

    Song, Mi; Chen, Zeng-Ping; Chen, Yao; Jin, Jing-Wen

    2014-07-01

    Liquid chromatography-mass spectrometry assays suffer from signal instability caused by the gradual fouling of the ion source, vacuum instability, aging of the ion multiplier, etc. To address this issue, in this contribution, an internal standard was added into the mobile phase. The internal standard was therefore ionized and detected together with the analytes of interest by the mass spectrometer to ensure that variations in measurement conditions and/or instrument have similar effects on the signal contributions of both the analytes of interest and the internal standard. Subsequently, based on the unique strategy of adding internal standard in mobile phase, a multiplicative effects model was developed for quantitative LC-MS assays and tested on a proof of concept model system: the determination of amino acids in water by LC-MS. The experimental results demonstrated that the proposed method could efficiently mitigate the detrimental effects of continuous signal variation, and achieved quantitative results with average relative predictive error values in the range of 8.0-15.0%, which were much more accurate than the corresponding results of conventional internal standard method based on the peak height ratio and partial least squares method (their average relative predictive error values were as high as 66.3% and 64.8%, respectively). Therefore, it is expected that the proposed method can be developed and extended in quantitative LC-MS analysis of more complex systems. Copyright © 2014 Elsevier B.V. All rights reserved.

  14. The Role of Internal Standards and their Interaction with Soils Impact Accuracy of Volatile Organics Determinations

    EPA Science Inventory

    Both US Environmental Protection Agency (EPA) SW-846 Methods 8260C/5035 and 8261A include mixing soil with water and addition of internal standards prior to analyses but the equilibration of internal standards with the soil is not required. With increasing total organic carbon (...

  15. Food irradiation: Standards, regulations and world-wide trade

    NASA Astrophysics Data System (ADS)

    Roberts, Peter B.

    2016-12-01

    There is an established framework of international standards for food irradiation covering human health, plant protection, labelling, dose delivery, quality assurance and facility management. Approximately 60 countries permit irradiation of one or more food or food classes. National regulations are briefly reviewed. Decontamination of spices, herbs and condiments remains the single largest application of irradiation. However, in recent years the market for irradiated fresh and processed meat has become firmly established in several countries including China and the USA. At least 10 countries have recently established bi-lateral agreements for trade in irradiated fresh fruits and vegetables using phytosanitary irradiation. Irradiated fresh produce volumes now exceed 20,000 t per year. Rationalization and greater consistency in labelling regulations would be advantageous to the future growth of applications of food irradiation.

  16. National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion Engines

    EPA Pesticide Factsheets

    This page contains the current National Emission Standards for Hazardous Air Pollutants (NESHAP) for Reciprocating Internal Combustion Engines and additional information regarding rule compliance and implementation.

  17. Influence of menu labeling on food choices in real-life settings: a systematic review.

    PubMed

    Fernandes, Ana C; Oliveira, Renata C; Proença, Rossana P C; Curioni, Cintia C; Rodrigues, Vanessa M; Fiates, Giovanna M R

    2016-08-01

    Evidence that menu labeling influences food choices in real-life settings is lacking. Reviews usually focus on calorie counts without addressing broader issues related to healthy eating. This systematic review assessed the influence of diverse menu-labeling formats on food choices in real-life settings. Several databases were searched: Cochrane Library, Scopus, MEDLINE, Web of Science, Food Science and Technology Abstracts, Biological Abstracts, CAB Abstracts, EconLit, SciELO, and LILACS. Articles reporting experiments, quasi-experiments, and observational studies using control or preintervention groups were selected blindly by two reviewers. Data was extracted using a standard form. Analyses differentiated between foodservice types. The quality of the 38 included studies was assessed blindly by two reviewers. The results were mixed, but a partial influence of menu labeling on food choices was more frequent than an overall influence or no influence. Menu labeling was more effective in cafeterias than in restaurants. Qualitative information, such as healthy-food symbols and traffic-light labeling, was most effective in promoting healthy eating. In general, the studies were of moderate quality and did not use control groups. Calorie labeling in menus is not effective to promote healthier food choices. Further research in real-life settings with control groups should test diverse qualitative information in menu labeling. © The Author(s) 2016. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  18. Concept for an International Standard related to Space Weather Effects on Space Systems

    NASA Astrophysics Data System (ADS)

    Tobiska, W. Kent; Tomky, Alyssa

    There is great interest in developing an international standard related to space weather in order to specify the tools and parameters needed for space systems operations. In particular, a standard is important for satellite operators who may not be familiar with space weather. In addition, there are others who participate in space systems operations that would also benefit from such a document. For example, the developers of software systems that provide LEO satellite orbit determination, radio communication availability for scintillation events (GEO-to-ground L and UHF bands), GPS uncertainties, and the radiation environment from ground-to-space for commercial space tourism. These groups require recent historical data, current epoch specification, and forecast of space weather events into their automated or manual systems. Other examples are national government agencies that rely on space weather data provided by their organizations such as those represented in the International Space Environment Service (ISES) group of 14 national agencies. Designers, manufacturers, and launchers of space systems require real-time, operational space weather parameters that can be measured, monitored, or built into automated systems. Thus, a broad scope for the document will provide a useful international standard product to a variety of engineering and science domains. The structure of the document should contain a well-defined scope, consensus space weather terms and definitions, and internationally accepted descriptions of the main elements of space weather, its sources, and its effects upon space systems. Appendices will be useful for describing expanded material such as guidelines on how to use the standard, how to obtain specific space weather parameters, and short but detailed descriptions such as when best to use some parameters and not others; appendices provide a path for easily updating the standard since the domain of space weather is rapidly changing with new advances

  19. How to Integrate International Financial Reporting Standards into Accounting Programs

    ERIC Educational Resources Information Center

    Singer, Robert A.

    2012-01-01

    It is expected the SEC will require U.S. domestic companies to prepare and file their annual 10Ks in accordance with international financial reporting standards (IFRS) by 2016. Given the probability that the FASB-IASB convergence project (i.e., Norwalk Agreement) will continue subsequent to mandatory adoption, US accounting programs will be…

  20. What consequences should result from failure to meet internal standards?

    PubMed

    Schramm, J

    1997-01-01

    This paper tries to approach a difficult problem, namely how to deal with a resident who has failed to meet the internal standards of a residency training program. First the problems of the definition of a standard and the associated problems of its reproducibility, documentation, teaching, update, and internal variability inside the same teaching program are dealt with. Consequently the question needs to be answered that constitutes a failure to meet the standard. The results of a survey of residents' attitudes are quoted as are some responses to a survey among the chiefs of teaching programs. Considering the attitudes of residents on how to handle breaches of standard the basic message was that residents want to be told that they do not function. Both parties want the collaboration of senior staff members on this topic. Whereas residents want to re-train, exercise and talk they do not want sanctions. Chiefs, however, want much less re-training, exercising and talking but earlier sanction. The difficult point of dealing with a true failure is discussed in the light of the German legal situation and the actual possibilities of how to handle the case. Before it comes to the point of discontinuing the training of a resident, it needs to be agreed upon what would be a classical situation of failure in which both the chiefs responsible for training and the residents agree that training is better discontinued. The author describes his experience with the real course of events in 7 cases he witnessed in 22 years.

  1. Accurate determination of arsenic in arsenobetaine standard solutions of BCR-626 and NMIJ CRM 7901-a by neutron activation analysis coupled with internal standard method.

    PubMed

    Miura, Tsutomu; Chiba, Koichi; Kuroiwa, Takayoshi; Narukawa, Tomohiro; Hioki, Akiharu; Matsue, Hideaki

    2010-09-15

    Neutron activation analysis (NAA) coupled with an internal standard method was applied for the determination of As in the certified reference material (CRM) of arsenobetaine (AB) standard solutions to verify their certified values. Gold was used as an internal standard to compensate for the difference of the neutron exposure in an irradiation capsule and to improve the sample-to-sample repeatability. Application of the internal standard method significantly improved linearity of the calibration curve up to 1 microg of As, too. The analytical reliability of the proposed method was evaluated by k(0)-standardization NAA. The analytical results of As in AB standard solutions of BCR-626 and NMIJ CRM 7901-a were (499+/-55)mgkg(-1) (k=2) and (10.16+/-0.15)mgkg(-1) (k=2), respectively. These values were found to be 15-20% higher than the certified values. The between-bottle variation of BCR-626 was much larger than the expanded uncertainty of the certified value, although that of NMIJ CRM 7901-a was almost negligible. Copyright (c) 2010 Elsevier B.V. All rights reserved.

  2. FDA regulations regarding iodine addition to foods and labeling of foods containing added iodine12

    PubMed Central

    Trumbo, Paula R

    2016-01-01

    The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, “This salt does not supply iodide, a necessary nutrient.” If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine. PMID:27534626

  3. Self-assessed performance improves statistical fusion of image labels

    PubMed Central

    Bryan, Frederick W.; Xu, Zhoubing; Asman, Andrew J.; Allen, Wade M.; Reich, Daniel S.; Landman, Bennett A.

    2014-01-01

    Purpose: Expert manual labeling is the gold standard for image segmentation, but this process is difficult, time-consuming, and prone to inter-individual differences. While fully automated methods have successfully targeted many anatomies, automated methods have not yet been developed for numerous essential structures (e.g., the internal structure of the spinal cord as seen on magnetic resonance imaging). Collaborative labeling is a new paradigm that offers a robust alternative that may realize both the throughput of automation and the guidance of experts. Yet, distributing manual labeling expertise across individuals and sites introduces potential human factors concerns (e.g., training, software usability) and statistical considerations (e.g., fusion of information, assessment of confidence, bias) that must be further explored. During the labeling process, it is simple to ask raters to self-assess the confidence of their labels, but this is rarely done and has not been previously quantitatively studied. Herein, the authors explore the utility of self-assessment in relation to automated assessment of rater performance in the context of statistical fusion. Methods: The authors conducted a study of 66 volumes manually labeled by 75 minimally trained human raters recruited from the university undergraduate population. Raters were given 15 min of training during which they were shown examples of correct segmentation, and the online segmentation tool was demonstrated. The volumes were labeled 2D slice-wise, and the slices were unordered. A self-assessed quality metric was produced by raters for each slice by marking a confidence bar superimposed on the slice. Volumes produced by both voting and statistical fusion algorithms were compared against a set of expert segmentations of the same volumes. Results: Labels for 8825 distinct slices were obtained. Simple majority voting resulted in statistically poorer performance than voting weighted by self-assessed performance

  4. A systematic review of calorie labeling and modified calorie labeling interventions: Impact on consumer and restaurant behavior

    PubMed Central

    Bleich, Sara N.; Economos, Christina D.; Spiker, Marie L.; Vercammen, Kelsey; VanEpps, Eric M.; Block, Jason P.; Elbel, Brian; Story, Mary; Roberto, Christina A.

    2017-01-01

    Background Evidence on the effects of restaurant calorie labeling on consumer and restaurant behavior is mixed. This paper examined: 1) consumer responses to calorie information alone or compared to modified calorie information, and 2) changes in restaurant offerings following or in advance of menu labeling implementation. Methods We searched PubMed, Web of Science, Policy File and PAIS International to identify restaurant calorie labeling studies through October 1, 2016, that measured calories ordered, consumed, or available for purchase on restaurant menus. We also searched reference lists of calorie labeling articles. Results Fifty-three studies were included: 18 in real-world restaurants, 9 in cafeterias, and 21 in laboratory or simulation settings. Five examined restaurant offerings. Conclusion Due to a lack of well-powered studies with strong designs, the degree to which menu labeling encourages lower calorie purchases and whether that translates to a healthier population is unclear. Although there is limited evidence that menu labeling affects calories purchased at fast-food restaurants, some evidence demonstrates that it lowers calories purchased at certain types of restaurants and in cafeteria settings. The limited data on modified calorie labels find that such labels can encourage lower-calorie purchases, but may not differ in effects relative to calorie labels alone. PMID:29045080

  5. A Systematic Review of Calorie Labeling and Modified Calorie Labeling Interventions: Impact on Consumer and Restaurant Behavior.

    PubMed

    Bleich, Sara N; Economos, Christina D; Spiker, Marie L; Vercammen, Kelsey A; VanEpps, Eric M; Block, Jason P; Elbel, Brian; Story, Mary; Roberto, Christina A

    2017-12-01

    Evidence on the effects of restaurant calorie labeling on consumer and restaurant behavior is mixed. This paper examined: (1) consumer responses to calorie information alone or compared to modified calorie information and (2) changes in restaurant offerings following or in advance of menu labeling implementation. Searches were conducted in PubMed, Web of Science, Policy File, and PAIS International to identify restaurant calorie labeling studies through October 1, 2016, that measured calories ordered, consumed, or available for purchase on restaurant menus. The reference lists of calorie labeling articles were also searched. Fifty-three studies were included: 18 in real-world restaurants, 9 in cafeterias, and 21 in laboratory or simulation settings. Five examined restaurant offerings. Because of a lack of well-powered studies with strong designs, the degree to which menu labeling encourages lower-calorie purchases and whether that translates to a healthier population are unclear. Although there is limited evidence that menu labeling affects calories purchased at fast-food restaurants, some evidence demonstrates that it lowers calories purchased at certain types of restaurants and in cafeteria settings. The limited data on modified calorie labels find that such labels can encourage lower-calorie purchases but may not differ in effects relative to calorie labels alone. © 2017 The Obesity Society.

  6. ASTM International Workshop on Standards & Measurements for Tissue Engineering Scaffolds

    PubMed Central

    Simon, Carl G.; Yaszemski, Michael J.; Ratcliffe, Anthony; Tomlins, Paul; Luginbuehl, Reto; Tesk, John A.

    2016-01-01

    The “Workshop on Standards & Measurements for Tissue Engineering Scaffolds” was held on May 21, 2013 in Indianapolis, IN and was sponsored by the ASTM International (ASTM). The purpose of the workshop was to identify the highest priority items for future standards work for scaffolds used in the development and manufacture of tissue engineered medical products (TEMPs). Eighteen speakers and 78 attendees met to assess current scaffold standards and to prioritize needs for future standards. A key finding was that the ASTM TEMPs subcommittees (F04.41-46) have many active “guide” documents for educational purposes, but that few standard “test methods” or “practices” have been published. Overwhelmingly, the most clearly identified need was standards for measuring the structure of scaffolds, followed by standards for biological characterization, including in vitro testing, animal models and cell-material interactions. The third most pressing need was to develop standards for assessing the mechanical properties of scaffolds. Additional needs included standards for assessing scaffold degradation, clinical outcomes with scaffolds, effects of sterilization on scaffolds, scaffold composition and drug release from scaffolds. Discussions also highlighted the need for additional scaffold reference materials and the need to use them for measurement traceability. Finally, dialogue emphasized the needs to promote the use of standards in scaffold fabrication, characterization, and commercialization and to assess the use and impact of standards in the TEMPs community. Many scaffold standard needs have been identified and focus should now turn to generating these standards to support the use of scaffolds in TEMPs. PMID:25220952

  7. Collaborative study to assess the suitability of a candidate International Standard for yellow fever vaccine.

    PubMed

    Ferguson, Morag; Heath, Alan

    2004-12-01

    Yellow fever vaccines are routinely assayed by plaque assay. However, the results of these assays are then converted into mouse LD(50) using correlations/conversion factors which, in many cases, were established many years ago. The minimum required potency in WHO Recommendations is 10(3) LD(50)/dose. Thirteen participants from 8 countries participated in a collaborative study whose aim was to assess the suitability of two candidate preparations to serve as an International Standard for yellow fever vaccine. In addition, the study investigated the relationship between the mouse LD(50) test and plaque forming units with a view to updating the WHO recommendations. Plaque assays were more reproducible than mouse assays, as expected. Differences in sensitivities of plaque assays were observed between laboratories but these differences appear to be consistent within a laboratory for all samples and the expression of potency relative to the candidate standard vaccine improved the reproducibility of assays between laboratories. However, the use of potencies had little effect on the between laboratory variability in mouse LD(50) assays. There appears to be a consistent relationship between overall mean LD(50) and plaques titre for all study preparations other than sample E. The slope of the correlation curve is >1 and it would appear that 10(3) LD(50) is approximately equivalent to 10(4) plaque forming units (PFU), based on the overall means of all laboratory results. The First International Standard for yellow fever vaccine, NIBSC Code 99/616, has been established as the First International Standard for yellow fever vaccine by the Expert Committee of Biological Standards of the World Health Organisation. The International Standard has been arbitrarily assigned a potency of 10(4.5) International Units (IU) per ampoule. Manufacturers and National Control Laboratories are including the First International Standard for yellow fever vaccine in routine assays so that the minimum

  8. Food nutrition labelling practice in China.

    PubMed

    Tao, Yexuan; Li, Ji; Lo, Y Martin; Tang, Qingya; Wang, Youfa

    2011-03-01

    The present study aimed to scrutinize the food nutrition labelling practice in China before the Chinese Food Nutrition Labeling Regulation (CFNLR) era. Nutrition information of pre-packaged foods collected from a supermarket between December 2007 and January 2008 was analysed and compared with findings from a survey conducted in Beijing. Information collected from a supermarket in Shanghai. A total of 850 pre-packaged foods. In the Shanghai survey, the overall labelling rate was 30·9 %, similar to that found in the Beijing study (29·7 %). While only 20·5 % of the snacks in Shanghai had nutrition labelling, the percentage of food items labelled with SFA (8·6 %), trans fatty acid (4·7 %) or fibre (12·1 %) was very low. Of those food items with nutrition labels, a considerable proportion (7-15 %) did not label energy, fat, carbohydrate or protein. Food products manufactured by Taiwan and Hong Kong companies had a lower labelling rate (13·6 %) than those manufactured by domestic (31·6 %) or international manufacturers (33·8 %). The very low food nutrition labelling rate among products sold in large chain supermarkets in major cities of China before CFNLR emphasizes the need for such critical regulations to be implemented in order to reinforce industrial compliance with accurate nutrition labelling.

  9. Codex Alimentarius: food quality and safety standards for international trade.

    PubMed

    Randell, A W; Whitehead, A J

    1997-08-01

    Since 1962, the Codex Alimentarius Commission (CAC) of the Food and Agriculture Organisation/World Health Organisation has been responsible for developing standards, guidelines and other recommendations on the quality and safety of food to protect the health of consumers and to ensure fair practices in food trade. The mission of the CAC remains relevant, but a number of factors have shown the need for new techniques to form the basis of food standards, the most important of which is risk analysis. The authors give a brief description of the role and work of the CAC and the efforts deployed by the Commission to respond to the challenges posed by new approaches to government regulation, harmonisation of national requirements based on international standards and the role of civil society.

  10. Halogenated Peptides as Internal Standards (H-PINS)

    PubMed Central

    Mirzaei, Hamid; Brusniak, Mi-Youn; Mueller, Lukas N.; Letarte, Simon; Watts, Julian D.; Aebersold, Ruedi

    2009-01-01

    As the application for quantitative proteomics in the life sciences has grown in recent years, so has the need for more robust and generally applicable methods for quality control and calibration. The reliability of quantitative proteomics is tightly linked to the reproducibility and stability of the analytical platforms, which are typically multicomponent (e.g. sample preparation, multistep separations, and mass spectrometry) with individual components contributing unequally to the overall system reproducibility. Variations in quantitative accuracy are thus inevitable, and quality control and calibration become essential for the assessment of the quality of the analyses themselves. Toward this end, the use of internal standards cannot only assist in the detection and removal of outlier data acquired by an irreproducible system (quality control) but can also be used for detection of changes in instruments for their subsequent performance and calibration. Here we introduce a set of halogenated peptides as internal standards. The peptides are custom designed to have properties suitable for various quality control assessments, data calibration, and normalization processes. The unique isotope distribution of halogenated peptides makes their mass spectral detection easy and unambiguous when spiked into complex peptide mixtures. In addition, they were designed to elute sequentially over an entire aqueous to organic LC gradient and to have m/z values within the commonly scanned mass range (300–1800 Da). In a series of experiments in which these peptides were spiked into an enriched N-glycosite peptide fraction (i.e. from formerly N-glycosylated intact proteins in their deglycosylated form) isolated from human plasma, we show the utility and performance of these halogenated peptides for sample preparation and LC injection quality control as well as for retention time and mass calibration. Further use of the peptides for signal intensity normalization and retention time

  11. Automated processing of label-free Raman microscope images of macrophage cells with standardized regression for high-throughput analysis.

    PubMed

    Milewski, Robert J; Kumagai, Yutaro; Fujita, Katsumasa; Standley, Daron M; Smith, Nicholas I

    2010-11-19

    Macrophages represent the front lines of our immune system; they recognize and engulf pathogens or foreign particles thus initiating the immune response. Imaging macrophages presents unique challenges, as most optical techniques require labeling or staining of the cellular compartments in order to resolve organelles, and such stains or labels have the potential to perturb the cell, particularly in cases where incomplete information exists regarding the precise cellular reaction under observation. Label-free imaging techniques such as Raman microscopy are thus valuable tools for studying the transformations that occur in immune cells upon activation, both on the molecular and organelle levels. Due to extremely low signal levels, however, Raman microscopy requires sophisticated image processing techniques for noise reduction and signal extraction. To date, efficient, automated algorithms for resolving sub-cellular features in noisy, multi-dimensional image sets have not been explored extensively. We show that hybrid z-score normalization and standard regression (Z-LSR) can highlight the spectral differences within the cell and provide image contrast dependent on spectral content. In contrast to typical Raman imaging processing methods using multivariate analysis, such as single value decomposition (SVD), our implementation of the Z-LSR method can operate nearly in real-time. In spite of its computational simplicity, Z-LSR can automatically remove background and bias in the signal, improve the resolution of spatially distributed spectral differences and enable sub-cellular features to be resolved in Raman microscopy images of mouse macrophage cells. Significantly, the Z-LSR processed images automatically exhibited subcellular architectures whereas SVD, in general, requires human assistance in selecting the components of interest. The computational efficiency of Z-LSR enables automated resolution of sub-cellular features in large Raman microscopy data sets without

  12. Coherent total internal reflection dark-field microscopy: label-free imaging beyond the diffraction limit.

    PubMed

    von Olshausen, Philipp; Rohrbach, Alexander

    2013-10-15

    Coherent imaging is barely applicable in life-science microscopy due to multiple interference artifacts. Here, we show how these interferences can be used to improve image resolution and contrast. We present a dark-field microscopy technique with evanescent illumination via total internal reflection that delivers high-contrast images of coherently scattering samples. By incoherent averaging of multiple coherent images illuminated from different directions we can resolve image structures that remain unresolved by conventional (incoherent) fluorescence microscopy. We provide images of 190 nm beads revealing resolution beyond the diffraction limit and slightly increased object distances. An analytical model is introduced that accounts for the observed effects and which is confirmed by numerical simulations. Our approach may be a route to fast, label-free, super-resolution imaging in live-cell microscopy.

  13. Testing the internal consistency of the standard gamble in 'success' and 'failure' frames.

    PubMed

    Oliver, Adam

    2004-06-01

    Decision making behaviour has often been shown to vary following changes in the way in which choice problems are described (or 'framed'). Moreover, a number of researchers have demonstrated that the standard gamble is prone to internal inconsistency, and loss aversion has been proposed as an explanation for this observed bias. This study attempts to alter the influence of loss aversion by framing the treatment arm of the standard gamble in terms of success (where we may expect the influence of loss aversion to be relatively weak) and in terms of failure (where we may expect the influence of loss aversion to be relatively strong). The objectives of the study are (1) to test whether standard gamble values vary when structurally identical gambles are differentially framed, and (2) to test whether the standard gamble is equally prone to internal inconsistency across the two frames. The results show that compared to framing in terms of treatment success, significantly higher values were inferred when the gamble was framed in terms of treatment failure. However, there was no difference in the quite marked levels of internal inconsistency observed in both frames. It is possible that the essential construct of the standard gamble induces substantial and/or widespread loss aversion irrespective of the way in which the gamble is framed, which offers a fundamental challenge to the usefulness of this value elicitation instrument. It is therefore recommended that further tests are undertaken on more sophisticated corrective procedures designed to limit the influence of loss aversion.

  14. International Standardization of the Clinical Dosimetry of Beta Radiation Brachytherapy Sources: Progress of an ISO Standard

    NASA Astrophysics Data System (ADS)

    Soares, Christopher

    2006-03-01

    In 2004 a new work item proposal (NWIP) was accepted by the International Organization for Standardization (ISO) Technical Committee 85 (TC85 -- Nuclear Energy), Subcommittee 2 (Radiation Protection) for the development of a standard for the clinical dosimetry of beta radiation sources used for brachytherapy. To develop this standard, a new Working Group (WG 22 - Ionizing Radiation Dosimetry and Protocols in Medical Applications) was formed. The standard is based on the work of an ad-hoc working group initiated by the Dosimetry task group of the Deutsches Insitiut für Normung (DIN). Initially the work was geared mainly towards the needs of intravascular brachytherapy, but with the decline of this application, more focus has been placed on the challenges of accurate dosimetry for the concave eye plaques used to treat ocular melanoma. Guidance is given for dosimetry formalisms, reference data to be used, calibrations, measurement methods, modeling, uncertainty determinations, treatment planning and reporting, and clinical quality control. The document is currently undergoing review by the ISO member bodies for acceptance as a Committee Draft (CD) with publication of the final standard expected by 2007. There are opportunities for other ISO standards for medical dosimetry within the framework of WG22.

  15. Development Of International Data Standards For The COSMOS/PEER-LL Virtual Data Center

    NASA Astrophysics Data System (ADS)

    Swift, J. N.

    2005-12-01

    The COSMOS -PEER Lifelines Project 2L02 completed a Pilot Geotechnical Virtual Data Center (GVDC) system capable of both archiving geotechnical data and of disseminating data from multiple linked geotechnical databases. The Pilot GVDC system links geotechnical databases of four organizations: the California Geological Survey, Caltrans, PG&E, and the U. S. Geological Survey The System was presented and reviewed in the COSMOS-PEER Lifelines workshop on June 21 - 23, 2004, which was co-sponsored by the Federal Highway Administration (FHWA) and included participation by the United Kingdom Highways Agency (UKHA) , the Association of Geotechnical and Geoenvironmental Specialists in the United Kingdom (AGS), the United States Army Corp of Engineers (USACOE), Caltrans, United States Geological Survey (USGS), California Geological Survey (CGS), a number of state Departments of Transportation (DOTs), county building code officials, and representatives of academic institutions and private sector geotechnical companies. As of February 2005 COSMOS-PEER Lifelines Project 2L03 is currently funded to accomplish the following tasks: 1) expand the Pilot GVDC Geotechnical Data Dictionary and XML Schema to include data definitions and structures to describe in-situ measurements such as shear wave velocity profiles, and additional laboratory geotechnical test types; 2) participate in an international cooperative working group developing a single geotechnical data exchange standard that has broad international acceptance; and 3) upgrade the GVDC system to support corresponding exchange standard data dictionary and schema improvements. The new geophysical data structures being developed will include PS-logs, downhole geophysical logs, cross-hole velocity data, and velocity profiles derived using surface waves. A COSMOS-PEER Lifelines Geophysical Data Dictionary Working Committee constituted of experts in the development of data dictionary standards and experts in the specific data to be

  16. Free viewpoint TV and its international standardization

    NASA Astrophysics Data System (ADS)

    Tanimoto, Masayuki

    2009-05-01

    We have developed a new type of television named FTV (Free-viewpoint TV). FTV is an innovative visual media that enables us to view a 3D scene by freely changing our viewpoints. We proposed the concept of FTV and constructed the world's first real-time system including the complete chain of operation from image capture to display. We also realized FTV on a single PC and FTV with free listening-point audio. FTV is based on the ray-space method that represents one ray in real space with one point in the ray-space. We have also developed new type of ray capture and display technologies such as a 360-degree mirror-scan ray capturing system and a 360 degree ray-reproducing display. MPEG regarded FTV as the most challenging 3D media and started the international standardization activities of FTV. The first phase of FTV is MVC (Multi-view Video Coding) and the second phase is 3DV (3D Video). MVC was completed in March 2009. 3DV is a standard that targets serving a variety of 3D displays. It will be completed within the next two years.

  17. 25 CFR 542.4 - How do these regulations affect minimum internal control standards established in a Tribal-State...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false How do these regulations affect minimum internal control standards established in a Tribal-State compact? 542.4 Section 542.4 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.4 How do these regulations affect minimum internal...

  18. 25 CFR 542.4 - How do these regulations affect minimum internal control standards established in a Tribal-State...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 2 2011-04-01 2011-04-01 false How do these regulations affect minimum internal control standards established in a Tribal-State compact? 542.4 Section 542.4 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.4 How do these regulations affect minimum internal...

  19. 25 CFR 542.4 - How do these regulations affect minimum internal control standards established in a Tribal-State...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 2 2013-04-01 2013-04-01 false How do these regulations affect minimum internal control standards established in a Tribal-State compact? 542.4 Section 542.4 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.4 How do these regulations affect minimum internal...

  20. 25 CFR 542.4 - How do these regulations affect minimum internal control standards established in a Tribal-State...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 2 2012-04-01 2012-04-01 false How do these regulations affect minimum internal control standards established in a Tribal-State compact? 542.4 Section 542.4 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.4 How do these regulations affect minimum internal...

  1. 25 CFR 542.4 - How do these regulations affect minimum internal control standards established in a Tribal-State...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false How do these regulations affect minimum internal control standards established in a Tribal-State compact? 542.4 Section 542.4 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS § 542.4 How do these regulations affect minimum internal...

  2. [Off-label therapies in oncology].

    PubMed

    Telekes, András

    2009-02-22

    The unapproved (off-label) therapies represent a special problem in oncology since they are in the borderline of legal regulation and of free medical practice. Although in Hungary the off-label therapies were regarded as clinical trials without permission until the new regulation came into action at the end of October 2008, certain experts were even so arguing for its use because clinical practice changes more rapidly than the prescription label. Moreover, manufacturers are not obliged to submit Supplemental New Drug Application in spite of the fact that enough evidence is generated to do so. The regulation of off-label therapies should meet the conditions of free medical practice, evidence-based medicine, demand of patients for new chances and expectations of regulatory authorities. In this paper, following the criticism of the Hungarian status and the new regulation, as well as the review of international practice, the author outlines the frame of a potential regulation separately indicating the role of practicing physicians and authorities.

  3. 7 CFR 201.8 - Contents of the label.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Contents of the label. 201.8 Section 201.8 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Labeling Agricultural Seeds §...

  4. 7 CFR 201.25 - Contents of the label.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Contents of the label. 201.25 Section 201.25 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Labeling Vegetable Seeds §...

  5. 7 CFR 201.25 - Contents of the label.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 3 2013-01-01 2013-01-01 false Contents of the label. 201.25 Section 201.25 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Labeling Vegetable Seeds §...

  6. 7 CFR 201.8 - Contents of the label.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 3 2013-01-01 2013-01-01 false Contents of the label. 201.8 Section 201.8 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Labeling Agricultural Seeds §...

  7. 7 CFR 201.8 - Contents of the label.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Contents of the label. 201.8 Section 201.8 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Labeling Agricultural Seeds §...

  8. 7 CFR 201.8 - Contents of the label.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 3 2012-01-01 2012-01-01 false Contents of the label. 201.8 Section 201.8 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Labeling Agricultural Seeds §...

  9. 7 CFR 201.25 - Contents of the label.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 3 2014-01-01 2014-01-01 false Contents of the label. 201.25 Section 201.25 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Labeling Vegetable Seeds §...

  10. 7 CFR 201.25 - Contents of the label.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Contents of the label. 201.25 Section 201.25 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Labeling Vegetable Seeds §...

  11. 7 CFR 201.25 - Contents of the label.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 3 2012-01-01 2012-01-01 false Contents of the label. 201.25 Section 201.25 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Labeling Vegetable Seeds §...

  12. 7 CFR 201.8 - Contents of the label.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 3 2014-01-01 2014-01-01 false Contents of the label. 201.8 Section 201.8 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Labeling Agricultural Seeds §...

  13. The Meaning of Curriculum-Related Examination Standards in Scotland and England: A Home-International Comparison

    ERIC Educational Resources Information Center

    Baird, Jo-Anne; Gray, Lena

    2016-01-01

    The ways in which examination standards are conceptualised and operationalised differently across nations has not been given sufficient attention. The international literature on standard-setting has been dominated by the psychometrics tradition. Broader conceptualisations of examination standards have been discussed in the literature in England,…

  14. An Experimental Study of the Internal Consistency of Judgments Made in Bookmark Standard Setting

    ERIC Educational Resources Information Center

    Clauser, Brian E.; Baldwin, Peter; Margolis, Melissa J.; Mee, Janet; Winward, Marcia

    2017-01-01

    Validating performance standards is challenging and complex. Because of the difficulties associated with collecting evidence related to external criteria, validity arguments rely heavily on evidence related to internal criteria--especially evidence that expert judgments are internally consistent. Given its importance, it is somewhat surprising…

  15. 75 FR 55269 - Minimum Internal Control Standards for Class II Gaming

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-10

    ... DEPARTMENT OF THE INTERIOR National Indian Gaming Commission 25 CFR Parts 542 and 543 RIN 3141-AA-37 Minimum Internal Control Standards for Class II Gaming AGENCY: National Indian Gaming Commission. ACTION: Delay of effective date of final rule; request for comments. SUMMARY: The National Indian Gaming...

  16. A Principles-Based Approach to Teaching International Financial Reporting Standards (IFRS)

    ERIC Educational Resources Information Center

    Persons, Obeua

    2014-01-01

    This article discusses the principles-based approach that emphasizes a "why" question by using the International Accounting Standards Board (IASB) "Conceptual Framework for Financial Reporting" to question and understand the basis for specific differences between IFRS and U.S. generally accepted accounting principles (U.S.…

  17. Implementing standardized, inter-unit communication in an international setting: handoff of patients from emergency medicine to internal medicine.

    PubMed

    Balhara, Kamna S; Peterson, Susan M; Elabd, Mohamed Moheb; Regan, Linda; Anton, Xavier; Al-Natour, Basil Ali; Hsieh, Yu-Hsiang; Scheulen, James; Stewart de Ramirez, Sarah A

    2018-04-01

    Standardized handoffs may reduce communication errors, but research on handoff in community and international settings is lacking. Our study at a community hospital in the United Arab Emirates characterizes existing handoff practices for admitted patients from emergency medicine (EM) to internal medicine (IM), develops a standardized handoff tool, and assesses its impact on communication and physician perceptions. EM physicians completed a survey regarding handoff practices and expectations. Trained observers utilized a checklist based on the Systems Engineering Initiative for Patient Safety model to observe 40 handoffs. EM and IM physicians collaboratively developed a written tool encouraging bedside handoff of admitted patients. After the intervention, surveys of EM physicians and 40 observations were subsequently repeated. 77.5% of initial observed handoffs occurred face-to-face, with 42.5% at bedside, and in four different languages. Most survey respondents considered face-to-face handoff ideal. Respondents noted 9-13 patients suffering harm due to handoff in the prior month. After handoff tool implementation, 97.5% of observed handoffs occurred face-to-face (versus 77.5%, p = 0.014), with 82.5% at bedside (versus 42.5%, p < 0.001), and all in English. Handoff was streamlined from 7 possible pathways to 3. Most post-intervention survey respondents reported improved workflow (77.8%) and safety (83.3%); none reported patient harm. Respondents and observers noted reduced inefficiency (p < 0.05). Our standardized tool increased face-to-face and bedside handoff, positively impacted workflow, and increased perceptions of safety by EM physicians in an international, non-academic setting. Our three-step approach can be applied towards developing standardized, context-specific inter-specialty handoff in a variety of settings.

  18. 25 CFR 543.14 - What are the minimum internal control standards for patron deposit accounts and cashless systems?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for patron deposit accounts and cashless systems? 543.14 Section 543.14 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.14 What are the minimum internal control...

  19. 25 CFR 543.12 - What are the minimum internal control standards for gaming promotions and player tracking systems?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 2 2013-04-01 2013-04-01 false What are the minimum internal control standards for gaming promotions and player tracking systems? 543.12 Section 543.12 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.12 What are the minimum internal contro...

  20. 25 CFR 543.14 - What are the minimum internal control standards for patron deposit accounts and cashless systems?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 2 2013-04-01 2013-04-01 false What are the minimum internal control standards for patron deposit accounts and cashless systems? 543.14 Section 543.14 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.14 What are the minimum internal control...

  1. 25 CFR 543.12 - What are the minimum internal control standards for gaming promotions and player tracking systems?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 2 2014-04-01 2014-04-01 false What are the minimum internal control standards for gaming promotions and player tracking systems? 543.12 Section 543.12 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM INTERNAL CONTROL STANDARDS FOR CLASS II GAMING § 543.12 What are the minimum internal contro...

  2. International standards for tuberculosis care: relevance and implications for laboratory professionals.

    PubMed

    Pai, M; Daley, P; Hopewell, P C

    2007-04-01

    On World Tuberculosis (TB) Day 2006, the International Standards for Tuberculosis Care (ISTC) was officially released and widely endorsed by several agencies and organizations. The ISTC release was the culmination of a year long global effort to develop and set internationally acceptable, evidence-based standards for tuberculosis care. The ISTC describes a widely endorsed level of care that all practitioners, public and private, should seek to achieve in managing individuals who have or are suspected of having, TB and is intended to facilitate the effective engagement of all healthcare providers in delivering high quality care for patients of all ages, including those with smear-positive, smear-negative and extra-pulmonary TB, TB caused by drug-resistant Mycobacterium tuberculosis and TB/HIV coinfection. In this article, we present the ISTC, with a special focus on the diagnostic standards and describe their implications and relevance for laboratory professionals in India and worldwide. Laboratory professionals play a critical role in ensuring that all the standards are actually met by providing high quality laboratory services for smear microscopy, culture and drug susceptibility testing and other services such as testing for HIV infection. In fact, if the ISTC is widely followed, it can be expected that there will be a greater need and demand for quality assured laboratory services and this will have obvious implications for all laboratories in terms of work load, requirement for resources and trained personnel and organization of quality assurance systems.

  3. International standards: the World Organisation for Animal Health Terrestrial Animal Health Code.

    PubMed

    Thiermann, A B

    2015-04-01

    This paper provides a description of the international standards contained in the TerrestrialAnimal Health Code of the World Organisation for Animal Health (OIE) that relate to the prevention and control of vector-borne diseases. It identifies the rights and obligations of OIE Member Countries regarding the notification of animal disease occurrences, as well as the recommendations to be followed for a safe and efficient international trade of animals and their products.

  4. How informative are open-label studies for youth with bipolar disorder? A meta-analysis comparing open-label versus randomized, placebo-controlled clinical trials.

    PubMed

    Biederman, Joseph; Petty, Carter R; Woodworth, K Yvonne; Lomedico, Alexandra; O'Connor, Katherine B; Wozniak, Janet; Faraone, Stephen V

    2012-03-01

    To examine the informativeness of open-label trials toward predicting results in subsequent randomized, placebo-controlled clinical trials of psychopharmacologic treatments for pediatric bipolar disorder. We searched journal articles through PubMed at the National Library of Medicine using bipolar disorder, mania, pharmacotherapy, treatment and clinical trial as keywords. This search was supplemented with scientific presentations at national and international scientific meetings and submitted manuscripts from our group. Selection criteria included (1) enrollment of children diagnosed with DSM-IV bipolar disorder; (2) prospective assessment of at least 3 weeks; (3) monotherapy of a pharmacologic treatment for bipolar disorder; (4) use of a randomized placebo-controlled design or an open-label design for the same therapeutic compound; and (5) repeated use of the Young Mania Rating Scale (YMRS) as an outcome. The following information and data were extracted from 14 studies: study design, name of medication, class of medication, dose of medication, sample size, age, sex, trial length, and YMRS mean and standard deviation baseline and follow-up scores. For both study designs, the pooled effect size was statistically significant (open-label studies, z = 8.88, P < .001; randomized placebo-controlled studies, z = 13.75, P < .001), indicating a reduction in the YMRS from baseline to endpoint in both study designs. In a meta-analysis regression, study design was not a significant predictor of mean change in the YMRS. We found similarities in the treatment effects between open-label and randomized placebo-controlled studies in youth with bipolar disorder indicating that open-label studies are useful predictors of the potential safety and efficacy of a given compound in the treatment of pediatric bipolar disorder. © Copyright 2012 Physicians Postgraduate Press, Inc.

  5. Nanodiamonds as multi-purpose labels for microscopy.

    PubMed

    Hemelaar, S R; de Boer, P; Chipaux, M; Zuidema, W; Hamoh, T; Martinez, F Perona; Nagl, A; Hoogenboom, J P; Giepmans, B N G; Schirhagl, R

    2017-04-07

    Nanodiamonds containing fluorescent nitrogen-vacancy centers are increasingly attracting interest for use as a probe in biological microscopy. This interest stems from (i) strong resistance to photobleaching allowing prolonged fluorescence observation times; (ii) the possibility to excite fluorescence using a focused electron beam (cathodoluminescence; CL) for high-resolution localization; and (iii) the potential use for nanoscale sensing. For all these schemes, the development of versatile molecular labeling using relatively small diamonds is essential. Here, we show the direct targeting of a biological molecule with nanodiamonds as small as 70 nm using a streptavidin conjugation and standard antibody labelling approach. We also show internalization of 40 nm sized nanodiamonds. The fluorescence from the nanodiamonds survives osmium-fixation and plastic embedding making them suited for correlative light and electron microscopy. We show that CL can be observed from epon-embedded nanodiamonds, while surface-exposed nanoparticles also stand out in secondary electron (SE) signal due to the exceptionally high diamond SE yield. Finally, we demonstrate the magnetic read-out using fluorescence from diamonds prior to embedding. Thus, our results firmly establish nanodiamonds containing nitrogen-vacancy centers as unique, versatile probes for combining and correlating different types of microscopy, from fluorescence imaging and magnetometry to ultrastructural investigation using electron microscopy.

  6. 76 FR 62961 - Lifesaving Equipment: Production Testing and Harmonization With International Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-11

    ... CFR Parts 108, 117, et al. Lifesaving Equipment: Production Testing and Harmonization With... Equipment: Production Testing and Harmonization With International Standards AGENCY: Coast Guard, DHS... equipment, including launching appliances (winches and davits), release mechanisms, survival craft...

  7. India Needs International Standards in Accreditation Problems in Adoption and Implementation

    ERIC Educational Resources Information Center

    Naik, B. M.

    2012-01-01

    The paper outlines in brief, need and importance of introducing global quality standards in accreditation, prescribed by the international agreement "Washington Accord". This agreement is initially provisional and after scrutiny, if found fit, it is upgraded to Signatory status. It is this status which empowers students of engineering,…

  8. Concept of Draft International Standard for a Unified Approach to Space Program Quality Assurance

    NASA Astrophysics Data System (ADS)

    Stryzhak, Y.; Vasilina, V.; Kurbatov, V.

    2002-01-01

    For want of the unified approach to guaranteed space project and product quality assurance, implementation of many international space programs has become a challenge. Globalization of aerospace industry and participation of various international ventures with diverse quality assurance requirements in big international space programs requires for urgent generation of unified international standards related to this field. To ensure successful fulfillment of space missions, aerospace companies should design and process reliable and safe products with properties complying or bettering User's (or Customer's) requirements. Quality of the products designed or processed by subcontractors (or other suppliers) should also be in compliance with the main user (customer)'s requirements. Implementation of this involved set of unified requirements will be made possible by creating and approving a system (series) of international standards under a generic title Space Product Quality Assurance based on a system consensus principle. Conceptual features of the baseline standard in this system (series) should comprise: - Procedures for ISO 9000, CEN and ECSS requirements adaptation and introduction into space product creation, design, manufacture, testing and operation; - Procedures for quality assurance at initial (design) phases of space programs, with a decision on the end product made based on the principle of independence; - Procedures to arrange incoming inspection of products delivered by subcontractors (including testing, audit of supplier's procedures, review of supplier's documentation), and space product certification; - Procedures to identify materials and primary products applied; - Procedures for quality system audit at the component part, primary product and materials supplier facilities; - Unified procedures to form a list of basic performances to be under configuration management; - Unified procedures to form a list of critical space product components, and unified

  9. Preparation and application of in-fibre internal standardization solid-phase microextraction.

    PubMed

    Zhao, Wennan; Ouyang, Gangfeng; Pawliszyn, Janusz

    2007-03-01

    The in-fibre standardization method is a novel approach that has been developed for field sampling/sample preparation, in which an internal standard is pre-loaded onto a solid-phase microextraction (SPME) fibre for calibration of the extraction of target analytes in field samples. The same method can also be used for in-vial sample analysis. In this study, different techniques to load the standard to a non-porous SPME fibre were investigated. It was found that the appropriateness of the technique depends on the physical properties of the standards that are used for the analysis. Headspace extraction of the standard dissolved in pumping oil works well for volatile compounds. Conversely, headspace extraction of the pure standard is an effective approach for semi-volatile compounds. For compounds with low volatility, a syringe-fibre transfer method and direct extraction of the standard dissolved in a solvent exhibited a good reproducibility (<5% RSD). The main advantage of the approaches investigated in this study is that the standard generation vials can be reused for hundreds of analyses without exhibiting significant loss. Moreover, most of the standard loading processes studied can be performed automatically, which is efficient and precise. Finally, the standard loading technique and in-fibre standardization method were applied to a complex matrix (milk) and the results illustrated that the matrix effect can be effectively compensated for with this approach.

  10. Novel isotopic N, N-Dimethyl Leucine (iDiLeu) Reagents Enable Absolute Quantification of Peptides and Proteins Using a Standard Curve Approach

    NASA Astrophysics Data System (ADS)

    Greer, Tyler; Lietz, Christopher B.; Xiang, Feng; Li, Lingjun

    2015-01-01

    Absolute quantification of protein targets using liquid chromatography-mass spectrometry (LC-MS) is a key component of candidate biomarker validation. One popular method combines multiple reaction monitoring (MRM) using a triple quadrupole instrument with stable isotope-labeled standards (SIS) for absolute quantification (AQUA). LC-MRM AQUA assays are sensitive and specific, but they are also expensive because of the cost of synthesizing stable isotope peptide standards. While the chemical modification approach using mass differential tags for relative and absolute quantification (mTRAQ) represents a more economical approach when quantifying large numbers of peptides, these reagents are costly and still suffer from lower throughput because only two concentration values per peptide can be obtained in a single LC-MS run. Here, we have developed and applied a set of five novel mass difference reagents, isotopic N, N-dimethyl leucine (iDiLeu). These labels contain an amine reactive group, triazine ester, are cost effective because of their synthetic simplicity, and have increased throughput compared with previous LC-MS quantification methods by allowing construction of a four-point standard curve in one run. iDiLeu-labeled peptides show remarkably similar retention time shifts, slightly lower energy thresholds for higher-energy collisional dissociation (HCD) fragmentation, and high quantification accuracy for trypsin-digested protein samples (median errors <15%). By spiking in an iDiLeu-labeled neuropeptide, allatostatin, into mouse urine matrix, two quantification methods are validated. The first uses one labeled peptide as an internal standard to normalize labeled peptide peak areas across runs (<19% error), whereas the second enables standard curve creation and analyte quantification in one run (<8% error).

  11. FDA regulations regarding iodine addition to foods and labeling of foods containing added iodine.

    PubMed

    Trumbo, Paula R

    2016-09-01

    The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, "This salt does not supply iodide, a necessary nutrient." If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine. © 2016 American Society for Nutrition.

  12. International Standards on stability of digital prints

    NASA Astrophysics Data System (ADS)

    Adelstein, Peter Z.

    2010-06-01

    The International Standards Organization (ISO) is a worldwide recognized standardizing body which has responsibility for standards on permanence of digital prints. This paper is an update on the progress made to date by ISO in writing test methods in this area. Three technologies are involved, namely ink jet, dye diffusion thermal transfer (dye-sublimation) and electrophotography. Two types of test methods are possible, namely comparative tests and predictive tests. To date a comparative test on water fastness has been published and final balloting is underway on a comparative test on humidity fastness. Predictive tests are being finalized on thermal stability and pollution susceptibility. The test method on thermal stability is intended to predict the print life during normal aging. One of the testing concerns is that some prints do not show significant image change in practical testing times. The test method on pollution susceptibility only deals with ozone and assumes that the reciprocity law applies. This law assumes that a long time under a low pollutant concentration is equivalent to a short time under the high concentration used in the test procedure. Longer term studies include a predictive test for light stability and the preparation of a material specification. The latter requires a decision about the proper colour target to be used and what constitutes an unacceptable colour change. Moreover, a specification which gives a predictive life is very dependent upon the conditions the print encounters and will only apply to specific levels of temperature, ozone and light.

  13. Weighing in on international growth standards: testing the case in Australian preschool children.

    PubMed

    Pattinson, C L; Staton, S L; Smith, S S; Trost, S G; Sawyer, E F; Thorpe, K J

    2017-10-01

    Overweight and obesity in preschool-aged children are major health concerns. Accurate and reliable estimates of prevalence are necessary to direct public health and clinical interventions. There are currently three international growth standards used to determine prevalence of overweight and obesity, each using different methodologies: Center for Disease Control (CDC), World Health Organization (WHO) and International Obesity Task Force (IOTF). Adoption and use of each method were examined through a systematic review of Australian population studies (2006-2017). For this period, systematically identified population studies (N = 20) reported prevalence of overweight and obesity ranging between 15 and 38% with most (n = 16) applying the IOTF standards. To demonstrate the differences in prevalence estimates yielded by the IOTF in comparison to the WHO and CDC standards, methods were applied to a sample of N = 1,926 Australian children, aged 3-5 years. As expected, the three standards yielded significantly different estimates when applied to this single population. Prevalence of overweight/obesity was WHO - 9.3%, IOTF - 21.7% and CDC - 33.1%. Judicious selection of growth standards, taking account of their underpinning methodologies and provisions of access to study data sets to allow prevalence comparisons, is recommended. © 2017 World Obesity Federation.

  14. The pluralization of the international: Resistance and alter-standardization in regenerative stem cell medicine

    PubMed Central

    Rosemann, Achim; Chaisinthop, Nattaka

    2016-01-01

    The article explores the formation of an international politics of resistance and ‘alter-standardization’ in regenerative stem cell medicine. The absence of internationally harmonized regulatory frameworks in the clinical stem cell field and the presence of lucrative business opportunities have resulted in the formation of transnational networks adopting alternative research standards and practices. These oppose, as a universal global standard, strict evidence-based medicine clinical research protocols as defined by scientists and regulatory agencies in highly developed countries. The emergence of transnational spaces of alter-standardization is closely linked to scientific advances in rapidly developing countries such as China and India, but calls for more flexible regulatory frameworks, and the legitimization of experimental for-profit applications outside of evidence-based medical care, are emerging increasingly also within more stringently regulated countries, such as the United States and countries in the European Union. We can observe, then, a trend toward the pluralization of the standards, practices, and concepts in the stem cell field. PMID:26983174

  15. Educational differences in the impact of pictorial cigarette warning labels on smokers: findings from the International Tobacco Control (ITC) Europe surveys.

    PubMed

    Nagelhout, Gera E; Willemsen, Marc C; de Vries, Hein; Mons, Ute; Hitchman, Sara C; Kunst, Anton E; Guignard, Romain; Siahpush, Mohammad; Yong, Hua-Hie; van den Putte, Bas; Fong, Geoffrey T; Thrasher, James F

    2016-05-01

    To examine (1) the impact of pictorial cigarette warning labels on changes in self-reported warning label responses: warning salience, cognitive responses, forgoing cigarettes and avoiding warnings, and (2) whether these changes differed by smokers' educational level. Longitudinal data of smokers from two survey waves of the International Tobacco Control (ITC) Europe Surveys were used. In France and the UK, pictorial warning labels were implemented on the back of cigarette packages between the two survey waves. In Germany and the Netherlands, the text warning labels did not change. Warning salience decreased between the surveys in France (OR=0.81, p=0.046) and showed a non-significant increase in the UK (OR=1.30, p=0.058), cognitive responses increased in the UK (OR=1.34, p<0.001) and decreased in France (OR=0.70, p=0.002), forgoing cigarettes increased in the UK (OR=1.65, p<0.001) and decreased in France (OR=0.83, p=0.047), and avoiding warnings increased in France (OR=2.93, p<0.001) and the UK (OR=2.19, p<0.001). Warning salience and cognitive responses decreased in Germany and the Netherlands, forgoing did not change in these countries and avoidance increased in Germany. In general, these changes in warning label responses did not differ by education. However, in the UK, avoidance increased especially among low (OR=2.25, p=0.001) and moderate educated smokers (OR=3.21, p<0.001). The warning labels implemented in France in 2010 and in the UK in 2008 with pictures on one side of the cigarette package did not succeed in increasing warning salience, but did increase avoidance. The labels did not increase educational inequalities among continuing smokers. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  16. International standards for newborn weight, length, and head circumference by gestational age and sex: the Newborn Cross-Sectional Study of the INTERGROWTH-21st Project.

    PubMed

    Villar, José; Cheikh Ismail, Leila; Victora, Cesar G; Ohuma, Eric O; Bertino, Enrico; Altman, Doug G; Lambert, Ann; Papageorghiou, Aris T; Carvalho, Maria; Jaffer, Yasmin A; Gravett, Michael G; Purwar, Manorama; Frederick, Ihunnaya O; Noble, Alison J; Pang, Ruyan; Barros, Fernando C; Chumlea, Cameron; Bhutta, Zulfiqar A; Kennedy, Stephen H

    2014-09-06

    In 2006, WHO published international growth standards for children younger than 5 years, which are now accepted worldwide. In the INTERGROWTH-21(st) Project, our aim was to complement them by developing international standards for fetuses, newborn infants, and the postnatal growth period of preterm infants. INTERGROWTH-21(st) is a population-based project that assessed fetal growth and newborn size in eight geographically defined urban populations. These groups were selected because most of the health and nutrition needs of mothers were met, adequate antenatal care was provided, and there were no major environmental constraints on growth. As part of the Newborn Cross-Sectional Study (NCSS), a component of INTERGROWTH-21(st) Project, we measured weight, length, and head circumference in all newborn infants, in addition to collecting data prospectively for pregnancy and the perinatal period. To construct the newborn standards, we selected all pregnancies in women meeting (in addition to the underlying population characteristics) strict individual eligibility criteria for a population at low risk of impaired fetal growth (labelled the NCSS prescriptive subpopulation). Women had a reliable ultrasound estimate of gestational age using crown-rump length before 14 weeks of gestation or biparietal diameter if antenatal care started between 14 weeks and 24 weeks or less of gestation. Newborn anthropometric measures were obtained within 12 h of birth by identically trained anthropometric teams using the same equipment at all sites. Fractional polynomials assuming a skewed t distribution were used to estimate the fitted centiles. We identified 20,486 (35%) eligible women from the 59,137 pregnant women enrolled in NCSS between May 14, 2009, and Aug 2, 2013. We calculated sex-specific observed and smoothed centiles for weight, length, and head circumference for gestational age at birth. The observed and smoothed centiles were almost identical. We present the 3rd, 10th, 50th, 90

  17. 78 FR 52532 - Exposure Draft-Standards for Internal Control in the Federal Government

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-23

    ... developments in the accountability and financial management profession and emphasize specific considerations applicable to the government environment. The draft of the proposed changes to Standards for Internal Control...

  18. Integrated Procedures for Flight and Ground Operations Using International Standards

    NASA Technical Reports Server (NTRS)

    Ingalls, John

    2011-01-01

    Imagine astronauts using the same Interactive Electronic Technical Manuals (IETM's) as the ground personnel who assemble or maintain their flight hardware, and having all of that data interoperable with design, logistics, reliability analysis, and training. Modern international standards and their corresponding COTS tools already used in other industries provide a good foundation for streamlined technical publications in the space industry. These standards cover everything from data exchange to product breakdown structure to business rules flexibility. Full Product Lifecycle Support (PLCS) is supported. The concept is to organize, build once, reuse many ways, and integrate. This should apply to all future and some current launch vehicles, payloads, space stations/habitats, spacecraft, facilities, support equipment, and retrieval ships.

  19. Category labels versus feature labels: category labels polarize inferential predictions.

    PubMed

    Yamauchi, Takashi; Yu, Na-Yung

    2008-04-01

    What makes category labels different from feature labels in predictive inference? This study suggests that category labels tend to make inductive reasoning polarized and homogeneous. In two experiments, participants were shown two schematic pictures of insects side by side and predicted the value of a hidden feature of one insect on the basis of the other insect. Arbitrary verbal labels were shown above the two pictures, and the meanings of the labels were manipulated in the instructions. In one condition, the labels represented the category membership of the insects, and in the other conditions, the same labels represented attributes of the insects. When the labels represented category membership, participants' responses became substantially polarized and homogeneous, indicating that the mere reference to category membership can modify reasoning processes.

  20. Lack of international consensus in low-risk drinking guidelines.

    PubMed

    Furtwaengler, Nina A F F; de Visser, Richard O

    2013-01-01

    To encourage moderate alcohol consumption, many governments have developed guidelines for alcohol intake, guidelines for alcohol consumption during pregnancy and legislation relating to blood alcohol limits when driving. The aim of this study was to determine the degree of international consensus within such guidelines. Official definitions of standard drinks and consumption guidelines were searched for on government websites, including all 27 European Union Member States and countries from all global geographic regions. There was a remarkable lack of agreement about what constitutes harmful or excessive alcohol consumption on a daily basis, a weekly basis and when driving, with no consensus about the ratios of consumption guidelines for men and women. International consensus in low-risk drinking guidelines is an important--and achievable--goal. Such agreement would facilitate consistent labelling of packaged products and could help to promote moderate alcohol consumption. However, there are some paradoxes related to alcohol content labelling and people's use of such information: although clearer information could increase people's capacity to monitor and regulate their alcohol consumption, not all drinkers are motivated to drink moderately or sensibly, and drinkers who intend to get drunk may use alcohol content labelling to select more alcoholic products. © 2012 Australasian Professional Society on Alcohol and other Drugs.

  1. International Labour Standards and Technical Co-Operation: The Case of Special Public Works Programmes.

    ERIC Educational Resources Information Center

    Mayer, Jean

    1989-01-01

    Applies international labor standards to results of the International Labour Office's special public works programs to discover whether program intentions have been met. Finds that while productive employment has been pursued, popular participation is not occurring and such issues as (1) forced labor, (2) child employment, and (3) inequality of…

  2. Developing alternative over-the-counter medicine label formats: How do they compare when evaluated by consumers?

    PubMed

    Tong, Vivien; Raynor, David K; Aslani, Parisa

    2018-03-01

    In recent years, the Australian Therapeutic Goods Administration (TGA) has proposed implementing a standardized over-the-counter (OTC) medicine label. However, there were mixed consumer opinions regarding a label proposed in 2012 and limited evidence demonstrating the usability of the revised (2014) format. To develop and examine the usability of alternative OTC medicine label formats for standardization, and explore consumer perspectives on the labels. Four alternative labels were developed for the exemplar medicine diclofenac. One was based on the Medicine Information label proposed by the TGA ('Medicine Information'), one was based on the U.S. Drug Facts label ('Drug Facts'), and two were based on suggestions proposed by consumers in the earlier needs analysis phase of this research (referred to as the 'Medicine Facts' and 'Consumer Desires' label formats). Five cohorts of 10 participants were recruited. Each cohort was assigned to user test one of the alternative labels or an existing label for a proprietary diclofenac product (which acted as a comparator) for diagnostic purposes. Each participant then provided feedback on all 5 labels. Each interview consisted of the administration of a user testing questionnaire, measuring consumers' ability to find and understand key points of information, and a semi-structured interview exploring consumer perspectives. Overall, all 4 alternative label formats supported consumers' ability to find and understand key points. The existing comparator label was the poorer label with respect to participants' ability to find and understand key points. Factors such as perceived usability, color, design, content, and/or content ordering impacted consumer preferences. The 'Consumer Desires' or 'Drug Facts' label formats were most often preferred by consumers for use as the standardized OTC label over the TGA proposed format. All alternative label formats demonstrated satisfactory usability and could be considered for use in OTC label

  3. Rabies vaccine standards: comparison of the 5th and 6th WHO international reference standards to the USDA veterinary reference standard.

    PubMed

    Hermann, J; Fry, A; Reising, M; Patterson, P; Siev, D; Gatewood, D

    2012-11-06

    Ensuring rabies vaccines are potent and effective is paramount in preventing transmission of this deadly disease and safeguarding public health. Efficacy of human and veterinary vaccines is ensured by evaluating relative potency estimates of the vaccine compared to a rabies reference standard using the National Institutes of Health (NIH) test. Reference vaccines are based on the International Standard for Rabies Vaccine provided by the World Health Organization (WHO). A comparison study was conducted to determine the relative potency of the 5th WHO, 6th WHO, and United States Department of Agriculture's (USDA) 08-14 reference standards using the NIH test. Results from the study demonstrate that the 6th WHO reference standard is approximately twice as potent as the 5th WHO reference when reconstituted to contain 1 IU per ml. Based on these results, the Center for Veterinary Biologics (CVB) doubled the reconstitution volume of USDA veterinary reference 08-14 from 13 ml to 26 ml, for an initial use dilution of 0.7 IU per ml for use by veterinary biologics manufacturers in the NIH test. This study emphasizes the importance of reference standard calibration for use in the National Institutes of Health test. Published by Elsevier Ltd.

  4. De novo synthesis of trideuteromethyl esters of amino acids for use in GC-MS and GC-tandem MS exemplified for ADMA in human plasma and urine: standardization, validation, comparison and proof of evidence for their aptitude as internal standards.

    PubMed

    Tsikas, Dimitrios

    2009-08-01

    Asymmetric dimethylarginine (ADMA, N(G),N(G)-dimethyl-L-arginine) is an endogenous inhibitor of nitric oxide (NO) synthesis, a potential risk factor for cardiovascular diseases and a powerful biochemical parameter in clinical studies. In our previous work we have reported on a GC-tandem MS method for the accurate and precise quantification of ADMA in biological fluids using de novo synthesized [(2)H(3)]-methyl ester ADMA (d(3)Me-ADMA) as internal standard (IS). This method provides basal ADMA concentrations in biological fluids that agree with those obtained by other groups using other validated methods for ADMA. Unanimously, de novo synthesized stable-isotope labeled analogues are considered not ideal IS, because they must be prepared in a matrix different from the biological sample. Recently, [2,3,3,4,4,5,5-(2)H(7)]-ADMA (d(7)-ADMA) has become commercially available and we took this opportunity to test the reliability of the de novo synthesized d(3)Me-ADMA as an IS for ADMA in GC-tandem MS. In this article, we report on the re-validation of the previously reported GC-tandem MS method for ADMA in human plasma and urine using d(7)-ADMA as IS, and on comparative quantitative analyses of ADMA by GC-tandem MS using d(7)-ADMA and d(3)Me-ADMA. After thorough standardization of d(7)-ADMA and methods validation, we obtained by GC-tandem MS very similar ADMA concentrations in plasma and urine using d(7)-ADMA and d(3)Me-ADMA. The present study gives a proof of evidence for the aptitude of (2)H(3)-ADMA as IS in GC-tandem MS and suggests that de novo synthesis of stable-isotope labeled alkyl esters of amino acids and amino acid derivates may be a generally applicable method in mass spectrometry-based methods for amino acids. This approach is especially useful for amino acids for which no stable-isotope labeled analogues are commercially available.

  5. Halogenated peptides as internal standards (H-PINS): introduction of an MS-based internal standard set for liquid chromatography-mass spectrometry.

    PubMed

    Mirzaei, Hamid; Brusniak, Mi-Youn; Mueller, Lukas N; Letarte, Simon; Watts, Julian D; Aebersold, Ruedi

    2009-08-01

    As the application for quantitative proteomics in the life sciences has grown in recent years, so has the need for more robust and generally applicable methods for quality control and calibration. The reliability of quantitative proteomics is tightly linked to the reproducibility and stability of the analytical platforms, which are typically multicomponent (e.g. sample preparation, multistep separations, and mass spectrometry) with individual components contributing unequally to the overall system reproducibility. Variations in quantitative accuracy are thus inevitable, and quality control and calibration become essential for the assessment of the quality of the analyses themselves. Toward this end, the use of internal standards cannot only assist in the detection and removal of outlier data acquired by an irreproducible system (quality control) but can also be used for detection of changes in instruments for their subsequent performance and calibration. Here we introduce a set of halogenated peptides as internal standards. The peptides are custom designed to have properties suitable for various quality control assessments, data calibration, and normalization processes. The unique isotope distribution of halogenated peptides makes their mass spectral detection easy and unambiguous when spiked into complex peptide mixtures. In addition, they were designed to elute sequentially over an entire aqueous to organic LC gradient and to have m/z values within the commonly scanned mass range (300-1800 Da). In a series of experiments in which these peptides were spiked into an enriched N-glycosite peptide fraction (i.e. from formerly N-glycosylated intact proteins in their deglycosylated form) isolated from human plasma, we show the utility and performance of these halogenated peptides for sample preparation and LC injection quality control as well as for retention time and mass calibration. Further use of the peptides for signal intensity normalization and retention time

  6. Using ASBO International's Standards To Map Your Professional Growth and Development Plan.

    ERIC Educational Resources Information Center

    Stratton, Susan

    2002-01-01

    Explores various definitions of what constitutes a profession and what characteristics determine a professional. Identifies the need for continued professional growth and development related to the new Association of School Business Officials, International, "Professional Standards" (2001). Examples illustrate how individual school…

  7. ASTM international workshop on standards and measurements for tissue engineering scaffolds.

    PubMed

    Simon, Carl G; Yaszemski, Michael J; Ratcliffe, Anthony; Tomlins, Paul; Luginbuehl, Reto; Tesk, John A

    2015-07-01

    The "Workshop on Standards & Measurements for Tissue Engineering Scaffolds" was held on May 21, 2013 in Indianapolis, IN, and was sponsored by the ASTM International (ASTM). The purpose of the workshop was to identify the highest priority items for future standards work for scaffolds used in the development and manufacture of tissue engineered medical products (TEMPs). Eighteen speakers and 78 attendees met to assess current scaffold standards and to prioritize needs for future standards. A key finding was that the ASTM TEMPs subcommittees (F04.41-46) have many active "guide" documents for educational purposes, but few standard "test methods" or "practices." Overwhelmingly, the most clearly identified need was standards for measuring the structure of scaffolds, followed by standards for biological characterization, including in vitro testing, animal models and cell-material interactions. The third most pressing need was to develop standards for assessing the mechanical properties of scaffolds. Additional needs included standards for assessing scaffold degradation, clinical outcomes with scaffolds, effects of sterilization on scaffolds, scaffold composition, and drug release from scaffolds. Discussions highlighted the need for additional scaffold reference materials and the need to use them for measurement traceability. Workshop participants emphasized the need to promote the use of standards in scaffold fabrication, characterization, and commercialization. Finally, participants noted that standards would be more broadly accepted if their impact in the TEMPs community could be quantified. Many scaffold standard needs have been identified and focus is turning to generating these standards to support the use of scaffolds in TEMPs. © 2014 Wiley Periodicals, Inc.

  8. Defining the Core Archive Data Standards of the International Planetary Data Alliance (IPDA)

    NASA Technical Reports Server (NTRS)

    Hughes, J. Steven; Crichton, Dan; Beebe, Reta; Guinness, Ed; Heather, David; Zender, Joe

    2007-01-01

    A goal of the International Planetary Data Alliance (lPDA) is to develop a set of archive data standards that enable the sharing of scientific data across international agencies and missions. To help achieve this goal, the IPDA steering committee initiated a six month proj ect to write requirements for and draft an information model based on the Planetary Data System (PDS) archive data standards. The project had a special emphasis on data formats. A set of use case scenarios were first developed from which a set of requirements were derived for the IPDA archive data standards. The special emphasis on data formats was addressed by identifying data formats that have been used by PDS nodes and other agencies in the creation of successful data sets for the Planetary Data System (PDS). The dependency of the IPDA information model on the PDS archive standards required the compilation of a formal specification of the archive standards currently in use by the PDS. An ontology modelling tool was chosen to capture the information model from various sources including the Planetary Science Data Dictionary [I] and the PDS Standards Reference [2]. Exports of the modelling information from the tool database were used to produce the information model document using an object-oriented notation for presenting the model. The tool exports can also be used for software development and are directly accessible by semantic web applications.

  9. ICA contribution to the development of international standards of competence for nautical cartographers

    NASA Astrophysics Data System (ADS)

    Furness, Ron; Tsoulos, Lysandros

    2018-05-01

    All professions face challenges as how best to ensure the achievement and continuance of the highest standards as they seek to determine and promulgate best practices. In the essentially linked professions of hydrographic surveying and nautical cartography these challenges become immediately international in their impacts and require close cooperation between the professional bodies representing surveyors, hydrographers and cartographers. The Standards of Competence for Nautical Cartographers are known in short form as S-8 and they describe the minimum required competencies for nautical cartographers. They indicate the minimum degree of knowledge and experience considered necessary for nautical cartographers and provide a set of programme outlines against which the FIG/IHO/ICA International Board on Standards of Competence for Hydrographic Surveyors and Nautical Cartographers may evaluate programmes submitted for recognition. The Standards recognize two levels of competence: Cate- gory A and Category B. In nautical charting communities, Category A programmes offer levels of comprehensive and broad-based knowledge in all aspects of the theory and practice of nautical cartography. Category B programmes provide a level of practical comprehension, along with the essential theoretical background, necessary for individuals to carry out the various nautical cartography tasks. The Standards have recently undergone complete review and should be ratified during 2017/18. This paper aims to bring the existence and aims of the Standards to the wider notice of ICA members and to describe the philosophy and aims of the review in meeting the professional competency needs of the nautical cartographic community.

  10. Interpreting international governance standards for health IT use within general medical practice.

    PubMed

    Mahncke, Rachel J; Williams, Patricia A H

    2014-01-01

    General practices in Australia recognise the importance of comprehensive protective security measures. Some elements of information security governance are incorporated into recommended standards, however the governance component of information security is still insufficiently addressed in practice. The International Organistion for Standardisation (ISO) released a new global standard in May 2013 entitled, ISO/IEC 27014:2013 Information technology - Security techniques - Governance of information security. This standard, applicable to organisations of all sizes, offers a framework against which to assess and implement the governance components of information security. The standard demonstrates the relationship between governance and the management of information security, provides strategic principles and processes, and forms the basis for establishing a positive information security culture. An analysis interpretation of this standard for use in Australian general practice was performed. This work is unique as such interpretation for the Australian healthcare environment has not been undertaken before. It demonstrates an application of the standard at a strategic level to inform existing development of an information security governance framework.

  11. Translating Radiometric Requirements for Satellite Sensors to Match International Standards.

    PubMed

    Pearlman, Aaron; Datla, Raju; Kacker, Raghu; Cao, Changyong

    2014-01-01

    International scientific standards organizations created standards on evaluating uncertainty in the early 1990s. Although scientists from many fields use these standards, they are not consistently implemented in the remote sensing community, where traditional error analysis framework persists. For a satellite instrument under development, this can create confusion in showing whether requirements are met. We aim to create a methodology for translating requirements from the error analysis framework to the modern uncertainty approach using the product level requirements of the Advanced Baseline Imager (ABI) that will fly on the Geostationary Operational Environmental Satellite R-Series (GOES-R). In this paper we prescribe a method to combine several measurement performance requirements, written using a traditional error analysis framework, into a single specification using the propagation of uncertainties formula. By using this approach, scientists can communicate requirements in a consistent uncertainty framework leading to uniform interpretation throughout the development and operation of any satellite instrument.

  12. Translating Radiometric Requirements for Satellite Sensors to Match International Standards

    PubMed Central

    Pearlman, Aaron; Datla, Raju; Kacker, Raghu; Cao, Changyong

    2014-01-01

    International scientific standards organizations created standards on evaluating uncertainty in the early 1990s. Although scientists from many fields use these standards, they are not consistently implemented in the remote sensing community, where traditional error analysis framework persists. For a satellite instrument under development, this can create confusion in showing whether requirements are met. We aim to create a methodology for translating requirements from the error analysis framework to the modern uncertainty approach using the product level requirements of the Advanced Baseline Imager (ABI) that will fly on the Geostationary Operational Environmental Satellite R-Series (GOES-R). In this paper we prescribe a method to combine several measurement performance requirements, written using a traditional error analysis framework, into a single specification using the propagation of uncertainties formula. By using this approach, scientists can communicate requirements in a consistent uncertainty framework leading to uniform interpretation throughout the development and operation of any satellite instrument. PMID:26601032

  13. Upcoming new international measurement standards in the field of building acoustics

    NASA Astrophysics Data System (ADS)

    Goydke, Hans

    2002-11-01

    The extensively completed revision of most of the ISO measurement standards in building acoustics mainly initiated by the European Commissions demand for harmonized standards emphasized the insight that the main goal to avoid trade barriers between the countries can only be reached when the standards sufficiently and comprehensively cover the field when they are related to the actual state of the art and when they are sufficiently related to practice. In modern architecture one can observe the rapid change in the use of building materials, for instance regarding the use of glass. Lightweight constructions as well as heavyweight building elements with additional linings are increasingly in common use and unquestionably there are consequences to be considered regarding the ascertainment of sound insulation properties. Besides others, International Standardization is unsatisfactory regarding the assessment of noise in buildings from waste water installations, in the low frequency area and in general regarding the expression of uncertainty of measurements. Intensity measurements in building acoustics, rainfall noise assessment, estimation of sound insulation, impulse response measurement methods, assessment of sound scattering are examples of upcoming standards.

  14. Challenges and Pitfalls Facing International Education in a Post-International World

    ERIC Educational Resources Information Center

    Tate, Nicholas

    2012-01-01

    Taking as its starting point that the adjective international is an inadequate, but unavoidable, label to describe the content of a contemporary international education, this article sets out to explore some of the issues facing international education in a post-international world. It draws mainly on writings in French as a deliberate…

  15. International Symposium on Information Technology: Standards for Bibliographic Control (Bangkok, Thailand, September 4-8, 1989).

    ERIC Educational Resources Information Center

    Thammasat Univ., Bangkok (Thailand). Univ. Libraries.

    This document which covers the proceedings of the 1989 International Symposium on Information Technology, begins with several opening ceremony messages and includes the following papers: (1) "Reflections on International Bibliographic Standards" (Winston D. Roberts); (2) "Bibliographic Control from the User's Perspective" (Ruth…

  16. 40 CFR 60.4231 - What emission standards must I meet if I am a manufacturer of stationary SI internal combustion...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... I am a manufacturer of stationary SI internal combustion engines or equipment containing such... Stationary Spark Ignition Internal Combustion Engines Emission Standards for Manufacturers § 60.4231 What emission standards must I meet if I am a manufacturer of stationary SI internal combustion engines or...

  17. 40 CFR 60.4231 - What emission standards must I meet if I am a manufacturer of stationary SI internal combustion...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... I am a manufacturer of stationary SI internal combustion engines or equipment containing such... Stationary Spark Ignition Internal Combustion Engines Emission Standards for Manufacturers § 60.4231 What emission standards must I meet if I am a manufacturer of stationary SI internal combustion engines or...

  18. 40 CFR 60.4231 - What emission standards must I meet if I am a manufacturer of stationary SI internal combustion...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... I am a manufacturer of stationary SI internal combustion engines or equipment containing such... Stationary Spark Ignition Internal Combustion Engines Emission Standards for Manufacturers § 60.4231 What emission standards must I meet if I am a manufacturer of stationary SI internal combustion engines or...

  19. 40 CFR 60.4231 - What emission standards must I meet if I am a manufacturer of stationary SI internal combustion...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... I am a manufacturer of stationary SI internal combustion engines or equipment containing such... Stationary Spark Ignition Internal Combustion Engines Emission Standards for Manufacturers § 60.4231 What emission standards must I meet if I am a manufacturer of stationary SI internal combustion engines or...

  20. 40 CFR 60.4231 - What emission standards must I meet if I am a manufacturer of stationary SI internal combustion...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... I am a manufacturer of stationary SI internal combustion engines or equipment containing such... Stationary Spark Ignition Internal Combustion Engines Emission Standards for Manufacturers § 60.4231 What emission standards must I meet if I am a manufacturer of stationary SI internal combustion engines or...

  1. Establishment of the first international standard for PEGylated granulocyte colony stimulating factor (PEG-G-CSF): Report of an international collaborative study

    PubMed Central

    Wadhwa, Meenu; Bird, Chris; Dougall, Thomas; Rigsby, Peter; Bristow, Adrian; Thorpe, Robin

    2015-01-01

    We assessed the feasibility of developing a suitable international reference standard for determination of in vitro biological activity of human sequence recombinant PEG-G-CSF products with a 20 kD linear PEG linked to the N-terminal methionyl residue of G-CSF (INN Filgrastim), produced using a conjugation process and coupling chemistry similar to that employed for the lead PEGfilgrastim product. Based on initial data which showed that the current WHO 2nd international standard, IS for G-CSF (09/136) or alternatively, a PEG-G-CSF standard with a unitage traceable to the G-CSF IS may potentially serve as the IS for PEG-G-CSF products, two candidate preparations of PEG-G-CSF were formulated and lyophilized at NIBSC. These preparations were tested by 23 laboratories using in vitro bioassays in a multi-centre collaborative study. Results indicated that on the basis of parallelism, the current WHO 2nd IS for G-CSF or any of the PEG-G-CSF samples could be used as the international standard for PEG-G-CSF preparations. However, because of the variability in potency estimates seen when PEG-G-CSF preparations were compared with the current WHO 2nd IS for G-CSF, a candidate PEG-G-CSF was suitable as the WHO IS. The preparation 12/188 was judged suitable to serve as the WHO IS based on in vitro biological activity data. Therefore, the preparation coded 12/188 was established by the WHO Expert Committee on Biological Standardization (ECBS) in 2013 as the WHO 1st IS for human PEGylated G-CSF with an assigned in vitro bioactivity of 10,000 IU per ampoule. PMID:25450254

  2. A change of course: The importance to DoD of international standards for electronic commerce

    NASA Astrophysics Data System (ADS)

    Payne, Judith E.

    1991-12-01

    The U.S. Department of Defense (DoD) is committed to using electronic commerce in the future with the over 300,000 vendors interested in doing business with DoD. Electronic commerce will move DoD from a paper-based world to one based on electronic transactions enabled by the exchange of formatted, electronic messages referred to as electronic data interchange (EDI). With electronic commerce, DoD plans to reduce costs, increase effectiveness, and make it easier for vendors to deal with DoD. Benefits from electronic commerce are enhanced when many businesses use the same standards for EDI messages themselves and their transmission. The fewer standards used, the less time and resources must be spent translating messages and agreeing on how to use different standards. To enhance benefits and smooth the transition to electronic commerce for itself and its vendors, DoD has chosen to use the widely accepted American National Standards Institute (ANSI) X12 standards for EDI messages, coupled with international standards for delivering messages and organizing addresses. In the past 18 months, EDI standards sponsored by a United Nations body and serving the same purpose as ANSI X12 message standards have begun to gain wider acceptance internationally.

  3. Off-label use of vaccines.

    PubMed

    Neels, Pieter; Southern, James; Abramson, Jon; Duclos, Philippe; Hombach, Joachim; Marti, Melanie; Fitzgerald-Husek, Alanna; Fournier-Caruana, Jacqueline; Hanquet, Germaine

    2017-04-25

    This article reviews the off-label recommendations and use of vaccines, and focuses on the differences between the labelled instructions on how to use the vaccine as approved by the regulatory authorities (or "label" 1 ), and the recommendations for use issued by public health advisory bodies at national and international levels. Differences between public health recommendations and the product label regarding the vaccine use can lead to confusion at the level of vaccinators and vaccinees and possibly result in lower compliance with national vaccination schedules. In particular, in many countries, the label may contain regulatory restrictions and warnings against vaccination of specific population groups (e.g. pregnant women) due to a lack of evidence of safety from controlled trials at the time of initial licensure of the vaccine, while public health authorities may recommend the same vaccine for that group, based on additional post-marketing data and benefit risk analyses. We provide an overview of the different responsibilities between regulatory authorities and public health advisory bodies, and the rationale for off-label use 2 of vaccines, the challenges involved based on the impact of off-label use in real-life. We propose to reduce off-label use of vaccines by requiring the manufacturer to regularly adapt the label as much as possible to the public health needs as supported by new evidence. This would require manufacturers to collect and report post-marketing data, communicate them to all stakeholders and regulators to extrapolate existing evidence (when acceptable) to other groups or to other brands of a vaccine (class effect 3 ). Regulatory authorities have a key role to play by requesting additional post-marketing data, e.g. in specific target groups. When public health recommendations for vaccine use that are outside labelled indications are considered necessary, good communication between regulatory bodies, public health authorities, companies and

  4. Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin.

    PubMed

    Vedula, S Swaroop; Li, Tianjing; Dickersin, Kay

    2013-01-01

    Details about the type of analysis (e.g., intent to treat [ITT]) and definitions (i.e., criteria for including participants in the analysis) are necessary for interpreting a clinical trial's findings. Our objective was to compare the description of types of analyses and criteria for including participants in the publication (i.e., what was reported) with descriptions in the corresponding internal company documents (i.e., what was planned and what was done). Trials were for off-label uses of gabapentin sponsored by Pfizer and Parke-Davis, and documents were obtained through litigation. For each trial, we compared internal company documents (protocols, statistical analysis plans, and research reports, all unpublished), with publications. One author extracted data and another verified, with a third person verifying discordant items and a sample of the rest. Extracted data included the number of participants randomized and analyzed for efficacy, and types of analyses for efficacy and safety and their definitions (i.e., criteria for including participants in each type of analysis). We identified 21 trials, 11 of which were published randomized controlled trials, and that provided the documents needed for planned comparisons. For three trials, there was disagreement on the number of randomized participants between the research report and publication. Seven types of efficacy analyses were described in the protocols, statistical analysis plans, and publications, including ITT and six others. The protocol or publication described ITT using six different definitions, resulting in frequent disagreements between the two documents (i.e., different numbers of participants were included in the analyses). Descriptions of analyses conducted did not agree between internal company documents and what was publicly reported. Internal company documents provide extensive documentation of methods planned and used, and trial findings, and should be publicly accessible. Reporting standards

  5. Estimation of internal and external nitrogen for corals with a long-term 15N-labelling experiment and subsequent model calculations

    NASA Astrophysics Data System (ADS)

    Tanaka, Yasuaki; Grottoli, Andréa; Matsui, Yohei; Suzuki, Atsushi; Sakai, Kazuhiko

    2014-05-01

    Coral reef ecosystems maintain high primary productivity though the seawater is extremely oligotrophic. One of the hypotheses to explain this paradox is the recycling of nutrients in animal-algal symbiotic organisms such as corals. It is relatively easy to measure nutrient uptake rates by corals from seawater, but the proportion of internally circulating nutrients between the coral host and the endosymbiotic algae (zooxanthellae) is more challenging. Here, we performed a long-term and continuous 15N-labelling experiment to quantify the proportionate contribution of seawater (external N source) and the animal host (internal N source) to the total N influx in the endosymbiotic algae. Branches from the scleractinian corals Porites cylindrica and Montipora digitata from Okinawa, Japan, were cultured for 2 months in indoor, flow-through, filtered seawater tanks with the continuous supply of 15N-labelled nitrate. At the initial and after 2, 4, and 9 weeks of the study, coral branches were collected and the algal and animal fractions were separated for isotopic analyses. In both corals, the N isotope ratio of symbiotic algae exponentially increased and the values were much higher than those of the host tissue, suggesting that the algae had a faster turnover N time than the animal host. Algal and host N biomass normalized to the coral surface area slowly decreased in both coral species over the study period. To calculate the contribution of internal and external N, a simple mixing model of algal N metabolism was designed. Using differential equations of 15N balance and N biomass balance, F1 and F2 (external and internal N fluxes to symbiotic algae, respectively) were expressed as the functions of time. The model calculations showed that F2 was much higher than F1 in P. cylindrica and the percentage of internal N to the total influx N (PIN) was >70%. On the other hand, the contribution of F1 and F2 was comparable in M. digitata and the PIN was 40-70%. These results

  6. 75 FR 53457 - Lifesaving Equipment: Production Testing and Harmonization With International Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... approval process for all lifesaving equipment required under the various vessel and facility regulations in... buoyant apparatuses. If the proposed rule is made final, all equipment approved after the effective date... Equipment: Production Testing and Harmonization With International Standards; Proposed Rule #0;#0;Federal...

  7. Rapid Verification of Candidate Serological Biomarkers Using Gel-based, Label-free Multiple Reaction Monitoring

    PubMed Central

    Tang, Hsin-Yao; Beer, Lynn A.; Barnhart, Kurt T.; Speicher, David W.

    2011-01-01

    Stable isotope dilution-multiple reaction monitoring-mass spectrometry (SID-MRM-MS) has emerged as a promising platform for verification of serological candidate biomarkers. However, cost and time needed to synthesize and evaluate stable isotope peptides, optimize spike-in assays, and generate standard curves, quickly becomes unattractive when testing many candidate biomarkers. In this study, we demonstrate that label-free multiplexed MRM-MS coupled with major protein depletion and 1-D gel separation is a time-efficient, cost-effective initial biomarker verification strategy requiring less than 100 μl serum. Furthermore, SDS gel fractionation can resolve different molecular weight forms of targeted proteins with potential diagnostic value. Because fractionation is at the protein level, consistency of peptide quantitation profiles across fractions permits rapid detection of quantitation problems for specific peptides from a given protein. Despite the lack of internal standards, the entire workflow can be highly reproducible, and long-term reproducibility of relative protein abundance can be obtained using different mass spectrometers and LC methods with external reference standards. Quantitation down to ~200 pg/mL could be achieved using this workflow. Hence, the label-free GeLC-MRM workflow enables rapid, sensitive, and economical initial screening of large numbers of candidate biomarkers prior to setting up SID-MRM assays or immunoassays for the most promising candidate biomarkers. PMID:21726088

  8. Rapid verification of candidate serological biomarkers using gel-based, label-free multiple reaction monitoring.

    PubMed

    Tang, Hsin-Yao; Beer, Lynn A; Barnhart, Kurt T; Speicher, David W

    2011-09-02

    Stable isotope dilution-multiple reaction monitoring-mass spectrometry (SID-MRM-MS) has emerged as a promising platform for verification of serological candidate biomarkers. However, cost and time needed to synthesize and evaluate stable isotope peptides, optimize spike-in assays, and generate standard curves quickly becomes unattractive when testing many candidate biomarkers. In this study, we demonstrate that label-free multiplexed MRM-MS coupled with major protein depletion and 1D gel separation is a time-efficient, cost-effective initial biomarker verification strategy requiring less than 100 μL of serum. Furthermore, SDS gel fractionation can resolve different molecular weight forms of targeted proteins with potential diagnostic value. Because fractionation is at the protein level, consistency of peptide quantitation profiles across fractions permits rapid detection of quantitation problems for specific peptides from a given protein. Despite the lack of internal standards, the entire workflow can be highly reproducible, and long-term reproducibility of relative protein abundance can be obtained using different mass spectrometers and LC methods with external reference standards. Quantitation down to ~200 pg/mL could be achieved using this workflow. Hence, the label-free GeLC-MRM workflow enables rapid, sensitive, and economical initial screening of large numbers of candidate biomarkers prior to setting up SID-MRM assays or immunoassays for the most promising candidate biomarkers.

  9. Use of Joint Commission International Standards to Evaluate and Improve Pediatric Oncology Nursing Care in Guatemala

    PubMed Central

    Day, Sara W.; McKeon, Leslie M.; Garcia, Jose; Wilimas, Judith A.; Carty, Rita M.; de Alarcon, Pedro; Antillon, Federico; Howard, Scott C.

    2017-01-01

    Background Inadequate nursing care is a major impediment to development of effective programs for treatment of childhood cancer in low-income countries. When the International Outreach Program at St. Jude Children’s Research Hospital established partner sites in low-income countries, few nurses had pediatric oncology skills or experience. A comprehensive nursing program was developed to promote the provision of quality nursing care, and in this manuscript we describe the program’s impact on 20 selected Joint Commission International (JCI) quality standards at the National Pediatric Oncology Unit in Guatemala. We utilized JCI standards to focus the nursing evaluation and implementation of improvements. These standards were developed to assess public hospitals in low-income countries and are recognized as the gold standard of international quality evaluation. Methods We compared the number of JCI standards met before and after the nursing program was implemented using direct observation of nursing care; review of medical records, policies, procedures, and job descriptions; and interviews with staff. Results In 2006, only 1 of the 20 standards was met fully, 2 partially, and 17 not met. In 2009, 16 were met fully, 1 partially, and 3 not met. Several factors contributed to the improvement. The pre-program quality evaluation provided objective and credible findings and an organizational framework for implementing change. The medical, administrative, and nursing staff worked together to improve nursing standards. Conclusion A systematic approach and involvement of all hospital disciplines led to significant improvement in nursing care that was reflected by fully meeting 16 of 20 standards. PMID:23015363

  10. Evaluating Varied Label Designs for Use with Medical Devices: Optimized Labels Outperform Existing Labels in the Correct Selection of Devices and Time to Select.

    PubMed

    Bix, Laura; Seo, Do Chan; Ladoni, Moslem; Brunk, Eric; Becker, Mark W

    2016-01-01

    Effective standardization of medical device labels requires objective study of varied designs. Insufficient empirical evidence exists regarding how practitioners utilize and view labeling. Measure the effect of graphic elements (boxing information, grouping information, symbol use and color-coding) to optimize a label for comparison with those typical of commercial medical devices. Participants viewed 54 trials on a computer screen. Trials were comprised of two labels that were identical with regard to graphics, but differed in one aspect of information (e.g., one had latex, the other did not). Participants were instructed to select the label along a given criteria (e.g., latex containing) as quickly as possible. Dependent variables were binary (correct selection) and continuous (time to correct selection). Eighty-nine healthcare professionals were recruited at Association of Surgical Technologists (AST) conferences, and using a targeted e-mail of AST members. Symbol presence, color coding and grouping critical pieces of information all significantly improved selection rates and sped time to correct selection (α = 0.05). Conversely, when critical information was graphically boxed, probability of correct selection and time to selection were impaired (α = 0.05). Subsequently, responses from trials containing optimal treatments (color coded, critical information grouped with symbols) were compared to two labels created based on a review of those commercially available. Optimal labels yielded a significant positive benefit regarding the probability of correct choice ((P<0.0001) LSM; UCL, LCL: 97.3%; 98.4%, 95.5%)), as compared to the two labels we created based on commercial designs (92.0%; 94.7%, 87.9% and 89.8%; 93.0%, 85.3%) and time to selection. Our study provides data regarding design factors, namely: color coding, symbol use and grouping of critical information that can be used to significantly enhance the performance of medical device labels.

  11. Preparation and analysis of deuterium-labeled aspirin: application to pharmacokinetic studies

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

    Pedersen, A.K.; FitzGerald, G.A.

    Inhibition of endogenous prostacyclin and thromboxane biosynthesis by aspirin is critically dose-dependent in humans. Gastrointestinal and hepatic hydrolysis may limit systemic availability of aspirin, especially in low doses, perhaps contributing to the biochemical selectivity of aspirin. Existing analytical methods do not permit determination of systemic bioavailability when low (less than 100 mg) doses of aspirin are administered. Deuterium-labeled aspirin (2-acetoxy(3,4,5,6-/sup 2/H4)benzoic acid) was synthesized from salicylic acid by catalytic exchange and subsequent acetylation. Analysis of the compounds as benzyl esters by GC-MS followed extractive alkylation from plasma. Heptadeuterated compounds were used as internal standards. Simultaneous administration of tetradeuterated aspirin intravenouslymore » with native aspirin orally to anesthetized dogs permitted kinetic studies of both aspirin and salicylic acid. The sensitivity of the method is superior to published methods using HPLC and, thus, more applicable to studies of low dose aspirin. Pulse administration of stable isotope-labeled aspirin permits detailed and repeated studies of dose-related aspirin pharmacokinetics in humans.« less

  12. Quantification of isotope-labelled and unlabelled folates in plasma, ileostomy and food samples.

    PubMed

    Büttner, Barbara E; Öhrvik, Veronica E; Witthöft, Cornelia M; Rychlik, Michael

    2011-01-01

    New stable isotope dilution assays were developed for the simultaneous quantitation of [(13)C(5)]-labelled and unlabelled 5-methyltetrahydrofolic acid, 5-formyltetrahydrofolic acid, folic acid along with unlabelled tetrahydrofolic acid and 10-formylfolic acid in clinical samples deriving from human bioavailability studies, i.e. plasma, ileostomy samples, and food. The methods were based on clean-up by strong anion exchange followed by LC-MS/MS detection. Deuterated analogues of the folates were applied as the internal standards in the stable isotope dilution assays. Assay sensitivity was sufficient to detect all relevant folates in the respective samples as their limits of detection were below 0.62 nmol/L in plasma and below 0.73 μg/100 g in food or ileostomy samples. Quantification of the [(13)C(5)]-label in clinical samples offers the possibility to differentiate between folate from endogenous body pools and the administered dose when executing bioavailability trials.

  13. Hierarchical Multi-atlas Label Fusion with Multi-scale Feature Representation and Label-specific Patch Partition

    PubMed Central

    Wu, Guorong; Kim, Minjeong; Sanroma, Gerard; Wang, Qian; Munsell, Brent C.; Shen, Dinggang

    2014-01-01

    label fusion results. In particular, a coarse-to-fine iterative label fusion approach is used that gradually reduces the patch size. To evaluate the accuracy of our label fusion approach, the proposed method was used to segment the hippocampus in the ADNI dataset and 7.0 tesla MR images, sub-cortical regions in LONI LBPA40 dataset, mid-brain regions in SATA dataset from MICCAI 2013 segmentation challenge, and a set of key internal gray matter structures in IXI dataset. In all experiments, the segmentation results of the proposed hierarchical label fusion method with multi-scale feature representations and label-specific atlas patches are more accurate than several well-known state-of-the-art label fusion methods. PMID:25463474

  14. International Standards for Neurological Classification of Spinal Cord Injury: cases with classification challenges.

    PubMed

    Kirshblum, S C; Biering-Sorensen, F; Betz, R; Burns, S; Donovan, W; Graves, D E; Johansen, M; Jones, L; Mulcahey, M J; Rodriguez, G M; Schmidt-Read, M; Steeves, J D; Tansey, K; Waring, W

    2014-03-01

    The International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) is routinely used to determine the levels of injury and to classify the severity of the injury. Questions are often posed to the International Standards Committee of the American Spinal Injury Association regarding the classification. The committee felt that disseminating some of the challenging questions posed, as well as the responses, would be of benefit for professionals utilizing the ISNCSCI. Case scenarios that were submitted to the committee are presented with the responses as well as the thought processes considered by the committee members. The importance of this documentation is to clarify some points as well as update the SCI community regarding possible revisions that will be needed in the future based upon some rules that require clarification.

  15. Standard line slopes as a measure of a relative matrix effect in quantitative HPLC-MS bioanalysis.

    PubMed

    Matuszewski, B K

    2006-01-18

    A simple experimental approach for studying and identifying the relative matrix effect (for example "plasma-to-plasma" and/or "urine-to-urine") in quantitative analyses by HPLC-MS/MS is described. Using as a database a large number of examples of methods developed in recent years in our laboratories, the relationship between the precision of standard line slopes constructed in five different lots of a biofluid (for example plasma) and the reliability of determination of concentration of an analyte in a particular plasma lot (or subject) was examined. In addition, the precision of standard line slopes was compared when stable isotope-labeled analytes versus analogs were used as internal standards (IS). Also, in some cases, a direct comparison of standard line slopes was made when different HPLC-MS interfaces (APCI versus ESI) were used for the assay of the same compound, using the same IS and the same sample preparation and chromatographic separation conditions. In selected cases, the precision of standard line slopes in five different lots of a biofluid was compared with precision values determined five times in a single lot. The results of these studies indicated that the variability of standard line slopes in different lots of a biofluid [precision of standard line slopes expressed as coefficient of variation, CV (%)] may serve as a good indicator of a relative matrix effect and, it is suggested, this precision value should not exceed 3-4% for the method to be considered reliable and free from the relative matrix effect liability. Based on the results presented, in order to assess the relative matrix effect in bioanalytical methods, it is recommended to perform assay precision and accuracy determination in five different lots of a biofluid, instead of repeat (n=5) analysis in the same, single biofluid lot, calculate standard line slopes and precision of these slopes, and to use <3-4% slope precision value as a guide for method applicability to support clinical

  16. Histotype-tailored neoadjuvant chemotherapy versus standard chemotherapy in patients with high-risk soft-tissue sarcomas (ISG-STS 1001): an international, open-label, randomised, controlled, phase 3, multicentre trial.

    PubMed

    Gronchi, Alessandro; Ferrari, Stefano; Quagliuolo, Vittorio; Broto, Javier Martin; Pousa, Antonio Lopez; Grignani, Giovanni; Basso, Umberto; Blay, Jean-Yves; Tendero, Oscar; Beveridge, Robert Diaz; Ferraresi, Virginia; Lugowska, Iwona; Merlo, Domenico Franco; Fontana, Valeria; Marchesi, Emanuela; Donati, Davide Maria; Palassini, Elena; Palmerini, Emanuela; De Sanctis, Rita; Morosi, Carlo; Stacchiotti, Silvia; Bagué, Silvia; Coindre, Jean Michelle; Dei Tos, Angelo Paolo; Picci, Piero; Bruzzi, Paolo; Casali, Paolo Giovanni

    2017-06-01

    Previous trials from our group suggested an overall survival benefit with five cycles of adjuvant full-dose epirubicin plus ifosfamide in localised high-risk soft-tissue sarcoma of the extremities or trunk wall, and no difference in overall survival benefit between three cycles versus five cycles of the same neoadjuvant regimen. We aimed to show the superiority of the neoadjuvant administration of histotype-tailored regimen to standard chemotherapy. For this international, open-label, randomised, controlled, phase 3, multicentre trial, patients were enrolled from 32 hospitals in Italy, Spain, France, and Poland. Eligible patients were aged 18 years or older with localised, high-risk (high malignancy grade, 5 cm or longer in diameter, and deeply located according to the investing fascia), soft-tissue sarcoma of the extremities or trunk wall and belonging to one of five histological subtypes: high-grade myxoid liposarcoma, leiomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumour, and undifferentiated pleomorphic sarcoma. Patients were randomly assigned (1:1) to receive three cycles of full-dose standard chemotherapy (epirubicin 60 mg/m 2 per day [short infusion, days 1 and 2] plus ifosfamide 3 g/m 2 per day [days 1, 2, and 3], repeated every 21 days) or histotype-tailored chemotherapy: for high-grade myxoid liposarcoma, trabectedin 1·3 mg/m 2 via 24-h continuous infusion, repeated every 21 days; for leiomyosarcoma, gemcitabine 1800 mg/m 2 on day 1 intravenously over 180 min plus dacarbazine 500 mg/m 2 on day 1 intravenously over 20 min, repeated every 14 days; for synovial sarcoma, high-dose ifosfamide 14 g/m 2 , given over 14 days via an external infusion pump, every 28 days; for malignant peripheral nerve sheath tumour, intravenous etoposide 150 mg/m 2 per day (days 1, 2, and 3) plus intravenous ifosfamide 3 g/m 2 per day (days 1, 2, and 3), repeated every 21 days; and for undifferentiated pleomorphic sarcoma, gemcitabine 900 mg/m 2 on days 1 and

  17. Evaluation of medical record quality and communication skills among pediatric interns after standardized parent training history-taking in China.

    PubMed

    Yu, Mu Xue; Jiang, Xiao Yun; Li, Yi Juan; Shen, Zhen Yu; Zhuang, Si Qi; Gu, Yu Fen

    2018-02-01

    The effect of using standardized parent training history-taking on the quality of medical records and communication skills among pediatric interns was determined. Fifth-year interns who were undertaking a pediatric clinical practice rotation were randomized to intervention and control groups. All of the pediatric interns received history-taking training by lecture and bedside teaching. The pediatric interns in the intervention group also received standardized parent history-taking training. The following two outcome measures were used: the scores of medical records, which were written by the pediatric interns after history-taking from real parents of pediatric patients; and the communication assessment tool (CAT) assessed by real parents. The general information, history of present illness (HPI), past medical history, personal history, family history, diagnosis, diagnostic analysis, and differential diagnosis scores in the intervention group were significantly higher than the control group (p < 0.05). Assessment of the CAT indicated that the real parents were more satisfied with the pediatric interns in the intervention group. Standardized parent training history-taking is effective in improving the quality of medical records by pediatric interns. Standardized parent training history-taking is a superior teaching tool for clinical reasoning ability, as well as communication skills in clinical pediatric practice.

  18. 76 FR 70062 - Lifesaving Equipment: Production Testing and Harmonization With International Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... DEPARTMENT OF HOMELAND SECURITY Coast Guard 46 CFR Parts 160, 180, and 199 [Docket No. USCG-2010-0048] RIN 1625-AB46 Lifesaving Equipment: Production Testing and Harmonization With International Standards Correction In rule document 2011-25035, appearing on pages 62962-63015 in the issue of Monday...

  19. Polymerization Kinetics: Monitoring Monomer Conversion Using an Internal Standard and the Key Role of Sample "t[subscript 0]"

    ERIC Educational Resources Information Center

    Colombani, Olivier; Langelier, Ophelie; Martwong, Ekkachai; Castignolles, Patrice

    2011-01-01

    The use of an internal standard is a conventional and convenient way to monitor the conversion of one or several monomers during a controlled radical polymerization. However, the validity of this technique relies on an accurate determination of the initial monomer-to-internal standard ratio, A[subscript 0], because all subsequent calculations of…

  20. International Standards and Reference Materials for Quantitative Molecular Infectious Disease Testing

    PubMed Central

    Madej, Roberta M.; Davis, Jack; Holden, Marcia J.; Kwang, Stan; Labourier, Emmanuel; Schneider, George J.

    2010-01-01

    The utility of quantitative molecular diagnostics for patient management depends on the ability to relate patient results to prior results or to absolute values in clinical practice guidelines. To do this, those results need to be comparable across time and methods, either by producing the same value across methods and test versions or by using reliable and stable conversions. Universally available standards and reference materials specific to quantitative molecular technologies are critical to this process but are few in number. This review describes recent history in the establishment of international standards for nucleic acid test development, organizations involved in current efforts, and future issues and initiatives. PMID:20075208

  1. International Consensus on Allergen Immunotherapy II: Mechanisms, standardization, and pharmacoeconomics.

    PubMed

    Jutel, Marek; Agache, Ioana; Bonini, Sergio; Burks, A Wesley; Calderon, Moises; Canonica, Walter; Cox, Linda; Demoly, Pascal; Frew, Antony J; O'Hehir, Robyn; Kleine-Tebbe, Jörg; Muraro, Antonella; Lack, Gideon; Larenas, Désirée; Levin, Michael; Martin, Bryan L; Nelson, Harald; Pawankar, Ruby; Pfaar, Oliver; van Ree, Ronald; Sampson, Hugh; Sublett, James L; Sugita, Kazunari; Du Toit, George; Werfel, Thomas; Gerth van Wijk, Roy; Zhang, Luo; Akdis, Mübeccel; Akdis, Cezmi A

    2016-02-01

    This article continues the comprehensive international consensus (ICON) statement on allergen immunotherapy (AIT). The initial article also recently appeared in the Journal. The conclusions below focus on key mechanisms of AIT-triggered tolerance, requirements in allergen standardization, AIT cost-effectiveness, and regulatory guidance. Potential barriers to and facilitators of the use of AIT are described in addition to future directions. International allergy specialists representing the European Academy of Allergy and Clinical Immunology; the American Academy of Allergy, Asthma & Immunology; the American College of Allergy, Asthma and Immunology; and the World Allergy Organization critically reviewed the existing literature and prepared this summary of recommendations for best AIT practice. The authors contributed equally and reached consensus on the statements presented herein. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  2. 77 FR 75400 - Labeling Requirements for Commercial and Industrial Equipment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-20

    .... EERE-2012-BT-NOA-0037] RIN 1904-AC84 Labeling Requirements for Commercial and Industrial Equipment... standards for certain commercial and industrial equipment, and requires the Department of Energy (DOE) to administer an energy conservation program for the equipment, including the development of labeling...

  3. Collaborative study for the calibration of a replacement International Standard for Tetanus Toxoid Adsorbed.

    PubMed

    Tierney, Rob; Stickings, Paul; Hockley, Jason; Rigsby, Peter; Iwaki, Masaaki; Sesardic, Dorothea

    2011-11-01

    We present the results of a collaborative study for the establishment of a replacement International Standard (IS) for Tetanus Toxoid Adsorbed. Two candidate preparations were included in the study, one of which was established as the 4th IS for Tetanus Toxoid Adsorbed at the WHO Expert Committee on Biological Standardization meeting in October 2010. This preparation was found to have a unitage of 490 IU/ampoule, based on calibration in guinea pig challenge assays. Results from mouse challenge assays suggest that the relative performance of two candidate preparations may differ significantly between guinea pigs and mice. The authors note that the number of laboratories that performed guinea pig challenge assays, which are used to calibrate and assign IU, is much lower than in previous collaborative studies and this may have implications for calibration of replacement standards in the future. The issue of assigning separate units to the IS for guinea pig and mouse assays is discussed. The study also assessed performance of the replacement standard in serological assays which are used as alternative procedures to challenge assays for tetanus potency testing. Results suggest that the replacement standard is suitable for use as the reference vaccine in serological assays. Copyright © 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  4. Reactions of Chinese adults to warning labels on cigarette packages: A survey in Jiangsu Province

    PubMed Central

    2011-01-01

    Background To compare reactions to warning labels presented on cigarette packages with a specific focus on whether the new Chinese warning labels are better than the old labels and international labels. Methods Participants aged 18 and over were recruited in two cities of Jiangsu Province in 2008, and 876 face-to-face interviews were completed. Participants were shown six types of warning labels found on cigarette packages. They comprised one old Chinese label, one new label used within the Chinese market, and one Chinese overseas label and three foreign brand labels. Participants were asked about the impact of the warning labels on: their knowledge of harm from smoking, giving cigarettes as a gift, and quitting smoking. Results Compared with the old Chinese label, a higher proportion of participants said the new label provided clear information on harm caused by smoking (31.2% vs 18.3%). Participants were less likely to give cigarettes with the new label on the package compared with the old label (25.2% vs 20.8%). These proportions were higher when compared to the international labels. Overall, 26.8% of participants would quit smoking based on information from the old label and 31.5% from the new label. When comparing the Chinese overseas label and other foreign labels to the new Chinese label with regard to providing knowledge of harm warning, impact of quitting smoking and giving cigarettes as a gift, the overseas labels were more effective. Conclusion Both the old and the new Chinese warning label are not effective in this target population. PMID:21349205

  5. International standards on working postures and movements ISO 11226 and EN 1005-4.

    PubMed

    Delleman, N J; Dul, J

    2007-11-01

    Standards organizations have given considerable attention to the problem of work-related musculoskeletal disorders. The publication of international standards for evaluating working postures and movements, ISO 11,226 in 2000 and EN 1,005-4 in 2005, may be considered as a support for those involved in preventing and controlling these disorders. The first one is a tool for evaluation of existing work situations, whereas the latter one is a tool for evaluation during a design/engineering process. Key publications and considerations that led to the content of the standards are presented, followed by examples of application.

  6. A decade of international cooperation brings a standard seismic point of view

    USGS Publications Warehouse

    Whitcomb, H. S

    1971-01-01

    Whether in a castle in Italy, a police station in Iceland, o an abandoned gold mine in Australia, the sensitive instruments in the Worldwide Seismograph Network send a steady flow of standard earthquake records to the geophysical scientific community. They provide the raw data that make possible very precise earthquake studies, precise because the instruments are identical and their product standard. A truly international program, this network of 115 stations in 61 countires and territories has laid the foundation for reserach in seismology for many years to come. 

  7. International development of methods of analysis for the presence of products of modern biotechnology.

    PubMed

    Cantrill, Richard C

    2008-01-01

    Methods of analysis for products of modern biotechnology are required for national and international trade in seeds, grain and food in order to meet the labeling or import/export requirements of different nations and trading blocks. Although many methods were developed by the originators of transgenic events, governments, universities, and testing laboratories, trade is less complicated if there exists a set of international consensus-derived analytical standards. In any analytical situation, multiple methods may exist for testing for the same analyte. These methods may be supported by regional preferences and regulatory requirements. However, tests need to be sensitive enough to determine low levels of these traits in commodity grain for regulatory purposes and also to indicate purity of seeds containing these traits. The International Organization for Standardization (ISO) and its European counterpart have worked to produce a suite of standards through open, balanced and consensus-driven processes. Presently, these standards are approaching the time for their first review. In fact, ISO 21572, the "protein standard" has already been circulated for systematic review. In order to expedite the review and revision of the nucleic acid standards an ISO Technical Specification (ISO/TS 21098) was drafted to set the criteria for the inclusion of precision data from collaborative studies into the annexes of these standards.

  8. Standard payload computer for the international space station

    NASA Astrophysics Data System (ADS)

    Knott, Karl; Taylor, Chris; Koenig, Horst; Schlosstein, Uwe

    1999-01-01

    This paper describes the development and application of a Standard PayLoad Computer (SPLC) which is being applied by the majority of ESA payloads accommodated on the International Space Station (ISS). The strategy of adopting of a standard computer leads to a radical rethink in the payload data handling procurement process. Traditionally, this has been based on a proprietary development with repeating costs for qualification, spares, expertise and maintenance for each new payload. Implementations have also tended to be unique with very little opportunity for reuse or utilisation of previous developments. While this may to some extent have been justified for short duration one-off missions, the availability of a standard, long term space infrastructure calls for a quite different approach. To support a large number of concurrent payloads, the ISS implementation relies heavily on standardisation, and this is particularly true in the area of payloads. Physical accommodation, data interfaces, protocols, component quality, operational requirements and maintenance including spares provisioning must all conform to a common set of standards. The data handling system and associated computer used by each payload must also comply with these common requirements, and thus it makes little sense to instigate multiple developments for the same task. The opportunity exists to provide a single computer suitable for all payloads, but with only a one-off development and qualification cost. If this is combined with the benefits of multiple procurement, centralised spares and maintenance, there is potential for great savings to be made by all those concerned in the payload development process. In response to the above drivers, the SPLC is based on the following concepts: • A one-off development and qualification process • A modular computer, configurable according to the payload developer's needs from a list of space-qualified items • An `open system' which may be added to by

  9. Determination of low intrinsic clearance in vitro: the benefit of a novel internal standard in human hepatocyte incubations.

    PubMed

    Zanelli, Ugo; Michna, Thomas; Petersson, Carl

    2018-03-26

    1. A novel method utilizing an internal standard in hepatocytes incubations has been developed and demonstrated to decrease the variability in the determination of intrinsic clearance (CL int ) in this system. The reduced variability was shown to allow differentiation of lower elimination rate constants from noise. 2. The suggested method was able to compensate for a small but systematic error (0.5 µL/min/10 6 cells) caused by an evaporation of approximately 15% of the volume during the incubation time. 3. The approach was validated using six commercial drugs (ketoprofen, tolbutamide, phenacetin, etodolac and quinidine) which were metabolized by different pathways. 4. The suggested internal standard, MSC1815677, was extensively characterized and the acquired data suggest that it fulfills the requirements of an internal standard present during the incubation. The proposed internal standard was stable during the incubation and showed a low potential to inhibit drug metabolizing enzymes and transporters. With MSC1815677 we propose a novel simple, robust and cost-effective method to address the challenges in the estimation of low clearance in hepatocyte incubations.

  10. Electron detachment dissociation of fluorescently labeled sialylated oligosaccharides.

    PubMed

    Zhou, Wen; Håkansson, Kristina

    2011-12-01

    We explored the application of electron detachment dissociation (EDD) and infrared multiphoton dissociation (IRMPD) tandem mass spectrometry to fluorescently labeled sialylated oligosaccharides. Standard sialylated oligosaccharides and a sialylated N-linked glycan released from human transferrin were investigated. EDD yielded extensive glycosidic cleavages and cross-ring cleavages in all cases studied, consistently providing complementary structural information compared with infrared multiphoton dissociation. Neutral losses and satellite ions such as C-2H ions were also observed following EDD. In addition, we examined the influence of different fluorescent labels. The acidic label 2-aminobenzoic acid (2-AA) enhanced signal abundance in negative-ion mode. However, few cross-ring fragments were observed for 2-AA-labeled oligosaccharides. The neutral label 2-aminobenzamide (2-AB) resulted in more cross-ring cleavages compared with 2-AA-labeled species, but not as extensive fragmentation as for native oligosaccharides, likely resulting from altered negative charge locations from introduction of the fluorescent tag. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  11. 40 CFR 1037.135 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 33 2014-07-01 2014-07-01 false Labeling. 1037.135 Section 1037.135 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF... that the vehicle meets or does not meet (such as European standards). You may also add other...

  12. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  13. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  14. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  15. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  16. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  17. Measurement of Henry's Law Constants Using Internal Standards: A Quantitative GC Experiment for the Instrumental Analysis or Environmental Chemistry Laboratory

    ERIC Educational Resources Information Center

    Ji, Chang; Boisvert, Susanne M.; Arida, Ann-Marie C.; Day, Shannon E.

    2008-01-01

    An internal standard method applicable to undergraduate instrumental analysis or environmental chemistry laboratory has been designed and tested to determine the Henry's law constants for a series of alkyl nitriles. In this method, a mixture of the analytes and an internal standard is prepared and used to make a standard solution (organic solvent)…

  18. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.

    PubMed

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff; Basch, Ethan; Bonnetain, Franck; Calvert, Melanie; Campbell, Alicyn; Cleeland, Charles; Cocks, Kim; Collette, Laurence; Dueck, Amylou C; Devlin, Nancy; Flechtner, Hans-Henning; Gotay, Carolyn; Greimel, Eva; Griebsch, Ingolf; Groenvold, Mogens; Hamel, Jean-Francois; King, Madeleine; Kluetz, Paul G; Koller, Michael; Malone, Daniel C; Martinelli, Francesca; Mitchell, Sandra A; Moinpour, Carol M; Musoro, Jammbe; O'Connor, Daniel; Oliver, Kathy; Piault-Louis, Elisabeth; Piccart, Martine; Pimentel, Francisco L; Quinten, Chantal; Reijneveld, Jaap C; Schürmann, Christoph; Smith, Ashley Wilder; Soltys, Katherine M; Taphoorn, Martin J B; Velikova, Galina; Coens, Corneel

    2016-11-01

    Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Quantitative surface-enhanced resonance Raman scattering of phthalocyanine-labelled oligonucleotides

    PubMed Central

    Macaskill, A.; Chernonosov, A. A.; Koval, V. V.; Lukyanets, E. A.; Fedorova, O. S.; Smith, W. E.; Faulds, K.; Graham, D.

    2007-01-01

    The evaluation of phthalocyanine labels for the surface-enhanced resonance Raman scattering (SERRS) detection of oligonucleotides is reported. Three phthalocyanine-labelled oligonucleotides were assessed, each containing a different metal centre. Detection limits for each labelled oligonucleotide were determined using two excitation frequencies where possible. Limits of detection as low as 2.8 × 10−11 mol. dm−3 were obtained which are comparable to standard fluorescently labelled probes used in previous SERRS studies. The identification of two phthalocyanine-labelled oligonucleotides without separation was also demonstrated indicating their suitability for multiplexing. This study extends the range of labels suitable for quantitative surface-enhanced resonance Raman scattering with silver nanoparticles and offers more flexibility and choice when considering SERRS for quantitative DNA detection. PMID:17289751

  20. Some issues relating to the use of perfluorooctanesulfonate (PFOS) samples as reference standards.

    PubMed

    Arsenault, Gilles; Chittim, Brock; McAlees, Alan; McCrindle, Robert; Riddell, Nicole; Yeo, Brian

    2008-01-01

    Samples of potassium perfluorooctanesulfonate (PFOSK) from three suppliers were analyzed by LC-ESI-MS/MS for purity and by LC-ESI-MS for the percentage of linear isomer present. Our data indicated that the purity ranged from 80% to 98% and the percentages of linear isomer from 67% to 79%. The proportion of branched isomers present in the samples was also estimated using (19)F NMR. These results agreed quite closely with those found by LC-ESI-MS indicating that there is essentially no difference in overall SIM response factor for the branched isomers vs. that of the linear isomer. Several further observations relevant to the use of standards when analyzing for PFOS were encountered during this study. It appears unlikely that matrix effects attributable to the cation (sodium or potassium) present in PFOSNa or PFOSK internal standards is an issue. In seeking potential matrix effects, it was found that the chromatography was improved substantially when the standard was injected as a solution in 80:20 methanol/water rather than 100% methanol. Notably, in concert with the improvement in chromatography, an increase of about 10% in response was observed. In some closely related studies, when (18)O(2) mass-labeled perfluorohexanesulfonate was used as an internal standard, the actual and theoretical concentration ratios matched closely those for related native sulfonates as long as they did not co-elute. However, when they did co-elute, the peak intensities of the native species were enhanced by about 5%, while those of the labeled compound were suppressed by a similar amount. If this effect were not taken into account, the concentration of the native would be inflated by 10%.

  1. An Exploratory Study of the Perceptions of AACSB International's 2013 Accreditation Standards

    ERIC Educational Resources Information Center

    Miles, Morgan P.; Franklin, Geralyn McClure; Grimmer, Martin; Heriot, Kirl C.

    2015-01-01

    Purpose: The purpose of this paper is to report on the findings of an exploratory survey designed to measure AACSB member deans' perceptions about the recently revised 2013 Association to Advance Collegiate Schools of Business (AACSB) Accreditation Standards. In April of 2013, AACSB International released a major revision of its accreditation…

  2. International migration: security concerns and human rights standards.

    PubMed

    Crépeau, François; Nakache, Delphine; Atak, Idil

    2007-09-01

    Over the last two decades, the reinforcement of security-related migration policies has resulted in the perception of the foreigner, and especially the irregular migrant, as a category outside the circle of legality. The rights of foreigners in host countries have deteriorated due to the connection made between immigration and criminality. Restrictions imposed upon irregular migrants' basic political and civil rights have been accompanied by major obstacles to their access to economic and social rights, including the right to health. The events of 9/11 further contributed to this trend, which contradicts the basic premises of the human rights paradigm. Recent policy developments and ongoing international cooperation implementing systematic interception and interdiction mechanisms have led to the securitization of migration. The preventive and deterrent measures reinforce the security paradigm. By contrast, various national and international actors have been successful in defending irregular migrants' rights. At the domestic level, the involvement of the judiciary and civil society enhances the rights-based approach to foreigners. The role of judges is vital in holding policy-makers accountable for respecting the high national standards of human rights protection. This article elaborates on the dichotomy between the state's legitimate interest to ensure national security, and its domestic and international obligations to protect human rights for all, including irregular migrants. It focuses on the changing relationship between migration and security, on the one hand, and between state and individual, on the other hand. It affirms the necessity to recognize the pre-eminence of fundamental rights upon security concerns.

  3. The Determination of Sugars in Dairy Products: Development of a New Standard Method for the International Dairy Federation and the Internal Organization for Standardization.

    PubMed

    Sanders, Peter; Ernste-Nota, Veronica; Visser, Klaas; van Soest, Jeroen; Brunt, Kommer

    2017-09-01

    A method using high-performance anion-exchange chromatography (HPAEC) with a pulsed amperometric detector (PAD) for the determination of mono- and disaccharides is described. The method was accepted by the International Dairy Federation and the Internal Organization for Standardization as a new work item for the determination of sugars in dairy matrixes, and the Milk and Milk Products technical committee of ISO/TC 34/SC 5 accepted the topic "Milk and milk products - Determination of the sugar contents - High-performance anion-exchange chromatographic method (HPAEC-PAD)" as a new work item. The proposed method consists of an aqueous ethanol extraction of the sugars in the dairy sample, followed by clarification with Carrez I and II reagents. The clarified filtrate is diluted and then directly introduced in the HPAEC-PAD system for quantification of the sugars. A single-laboratory validation of the proposed method has been scheduled for spring 2017.

  4. Isotopic studies of metabolic systems by mass spectrometry: using Pascal's triangle to produce biological standards with fully controlled labeling patterns.

    PubMed

    Millard, Pierre; Massou, Stéphane; Portais, Jean-Charles; Létisse, Fabien

    2014-10-21

    Mass spectrometry (MS) is widely used for isotopic studies of metabolism in which detailed information about biochemical processes is obtained from the analysis of isotope incorporation into metabolites. The biological value of such experiments is dependent on the accuracy of the isotopic measurements. Using MS, isotopologue distributions are measured from the quantitative analysis of isotopic clusters. These measurements are prone to various biases, which can occur during the experimental workflow and/or MS analysis. The lack of relevant standards limits investigations of the quality of the measured isotopologue distributions. To meet that need, we developed a complete theoretical and experimental framework for the biological production of metabolites with fully controlled and predictable labeling patterns. This strategy is valid for different isotopes and different types of metabolisms and organisms, and was applied to two model microorganisms, Pichia augusta and Escherichia coli, cultivated on (13)C-labeled methanol and acetate as sole carbon source, respectively. The isotopic composition of the substrates was designed to obtain samples in which the isotopologue distribution of all the metabolites should give the binomial coefficients found in Pascal's triangle. The strategy was validated on a liquid chromatography-tandem mass spectrometry (LC-MS/MS) platform by quantifying the complete isotopologue distributions of different intracellular metabolites, which were in close agreement with predictions. This strategy can be used to evaluate entire experimental workflows (from sampling to data processing) or different analytical platforms in the context of isotope labeling experiments.

  5. International estimated fetal weight standards of the INTERGROWTH-21st Project.

    PubMed

    Stirnemann, J; Villar, J; Salomon, L J; Ohuma, E; Ruyan, P; Altman, D G; Nosten, F; Craik, R; Munim, S; Cheikh Ismail, L; Barros, F C; Lambert, A; Norris, S; Carvalho, M; Jaffer, Y A; Noble, J A; Bertino, E; Gravett, M G; Purwar, M; Victora, C G; Uauy, R; Bhutta, Z; Kennedy, S; Papageorghiou, A T

    2017-04-01

    Estimated fetal weight (EFW) and fetal biometry are complementary measures used to screen for fetal growth disturbances. Our aim was to provide international EFW standards to complement the INTERGROWTH-21 st Fetal Growth Standards that are available for use worldwide. Women with an accurate gestational-age assessment, who were enrolled in the prospective, international, multicenter, population-based Fetal Growth Longitudinal Study (FGLS) and INTERBIO-21 st Fetal Study (FS), two components of the INTERGROWTH-21 st Project, had ultrasound scans every 5 weeks from 9-14 weeks' until 40 weeks' gestation. At each visit, measurements of fetal head circumference (HC), biparietal diameter, occipitofrontal diameter, abdominal circumference (AC) and femur length (FL) were obtained blindly by dedicated research sonographers using standardized methods and identical ultrasound machines. Birth weight was measured within 12 h of delivery by dedicated research anthropometrists using standardized methods and identical electronic scales. Live babies without any congenital abnormality, who were born within 14 days of the last ultrasound scan, were selected for inclusion. As most births occurred at around 40 weeks' gestation, we constructed a bootstrap model selection and estimation procedure based on resampling of the complete dataset under an approximately uniform distribution of birth weight, thus enriching the sample size at extremes of fetal sizes, to achieve consistent estimates across the full range of fetal weight. We constructed reference centiles using second-degree fractional polynomial models. Of the overall population, 2404 babies were born within 14 days of the last ultrasound scan. Mean time between the last scan and birth was 7.7 (range, 0-14) days and was uniformly distributed. Birth weight was best estimated as a function of AC and HC (without FL) as log(EFW) = 5.084820 - 54.06633 × (AC/100) 3  - 95.80076 × (AC/100) 3  × log(AC/100)

  6. Proposed Standards for Medical Education Submissions to the Journal of General Internal Medicine

    PubMed Central

    Bowen, Judith L.; Gerrity, Martha S.; Kalet, Adina L.; Kogan, Jennifer R.; Spickard, Anderson; Wayne, Diane B.

    2008-01-01

    To help authors design rigorous studies and prepare clear and informative manuscripts, improve the transparency of editorial decisions, and raise the bar on educational scholarship, the Deputy Editors of the Journal of General Internal Medicine articulate standards for medical education submissions to the Journal. General standards include: (1) quality questions, (2) quality methods to match the questions, (3) insightful interpretation of findings, (4) transparent, unbiased reporting, and (5) attention to human subjects’ protection and ethical research conduct. Additional standards for specific study types are described. We hope these proposed standards will generate discussion that will foster their continued evolution. Electronic supplementary material The online version of this article (doi:10.1007/s11606-008-0676-z) contains supplementary material, which is available to authorized users. PMID:18612716

  7. Starworld: Preparing Accountants for the Future: A Case-Based Approach to Teach International Financial Reporting Standards Using ERP Software

    ERIC Educational Resources Information Center

    Ragan, Joseph M.; Savino, Christopher J.; Parashac, Paul; Hosler, Jonathan C.

    2010-01-01

    International Financial Reporting Standards now constitute an important part of educating young professional accountants. This paper looks at a case based process to teach International Financial Reporting Standards using integrated Enterprise Resource Planning software. The case contained within the paper can be used within a variety of courses…

  8. 21 CFR 660.55 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... identify antibody specificities other than anti-IgG and anti-C3d but the reactivity of the Anti-Human... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Anti-Human Globulin § 660.55 Labeling. In addition...

  9. 21 CFR 660.55 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... identify antibody specificities other than anti-IgG and anti-C3d but the reactivity of the Anti-Human... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Anti-Human Globulin § 660.55 Labeling. In addition...

  10. 21 CFR 660.55 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... identify antibody specificities other than anti-IgG and anti-C3d but the reactivity of the Anti-Human... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Anti-Human Globulin § 660.55 Labeling. In addition...

  11. 21 CFR 660.55 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... identify antibody specificities other than anti-IgG and anti-C3d but the reactivity of the Anti-Human... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Anti-Human Globulin § 660.55 Labeling. In addition...

  12. 40 CFR 1042.135 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... fixed-pitch propellers, etc.). If the engine is certified as a recreational engine, state: “INSTALLING... EMISSIONS FROM NEW AND IN-USE MARINE COMPRESSION-IGNITION ENGINES AND VESSELS Emission Standards and Related Requirements § 1042.135 Labeling. (a) Assign each engine a unique identification number and permanently affix...

  13. 40 CFR 1042.135 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... fixed-pitch propellers, etc.). If the engine is certified as a recreational engine, state: “INSTALLING... EMISSIONS FROM NEW AND IN-USE MARINE COMPRESSION-IGNITION ENGINES AND VESSELS Emission Standards and Related Requirements § 1042.135 Labeling. (a) Assign each engine a unique identification number and permanently affix...

  14. 40 CFR 1042.135 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... fixed-pitch propellers, etc.). If the engine is certified as a recreational engine, state: “INSTALLING... EMISSIONS FROM NEW AND IN-USE MARINE COMPRESSION-IGNITION ENGINES AND VESSELS Emission Standards and Related Requirements § 1042.135 Labeling. (a) Assign each engine a unique identification number and permanently affix...

  15. Standardization of haematology critical results management in adults: an International Council for Standardization in Haematology, ICSH, survey and recommendations.

    PubMed

    Keng, T B; De La Salle, B; Bourner, G; Merino, A; Han, J-Y; Kawai, Y; Peng, M T; McCafferty, R

    2016-10-01

    These recommendations are intended to develop a consensus in the previously published papers as to which parameters and what values should be considered critical. A practical guide on the standardization of critical results management in haematology laboratories would be beneficial as part of good laboratory and clinical practice and for use by laboratory-accrediting agencies. A working group with members from Europe, America, Australasia and Asia was formed by International Council for Standardization in Haematology. A pattern of practice survey of 21 questions was distributed in 2014, and the data were collected electronically by Survey Monkey. The mode, or most commonly occurring value, was selected as the threshold for the upper and lower alert limits for critical results reporting. A total of 666 laboratories submitted data to this study and, of these, 499 submitted complete responses. Full blood count critical results alert thresholds, morphology findings that trigger critical result notification, critical results alert list, notification process and maintenance of critical results management protocol are described. This international survey provided a snapshot of the current practice worldwide and has identified the existence of considerable heterogeneity of critical results management. The recommendations in this study represent a consensus of good laboratory practice. They are intended to encourage the implementation of a standardized critical results management protocol in the laboratory. © 2016 John Wiley & Sons Ltd.

  16. International Comparisons of Foundation Phase Number Domain Mathematics Knowledge and Practice Standards

    ERIC Educational Resources Information Center

    Human, Anja; van der Walt, Marthie; Posthuma, Barbara

    2015-01-01

    Poor mathematics performance in schools is both a national and an international concern. Teachers ought to be equipped with relevant subject matter knowledge and pedagogical content knowledge as one way to address this problem. However, no mathematics knowledge and practice standards have as yet been defined for the preparation of Foundation Phase…

  17. Partial synthesis of ganglioside and lysoganglioside lipoforms as internal standards for MS quantification.

    PubMed

    Gantner, Martin; Schwarzmann, Günter; Sandhoff, Konrad; Kolter, Thomas

    2014-12-01

    Within recent years, ganglioside patterns have been increasingly analyzed by MS. However, internal standards for calibration are only available for gangliosides GM1, GM2, and GM3. For this reason, we prepared homologous internal standards bearing nonnatural fatty acids of the major mammalian brain gangliosides GM1, GD1a, GD1b, GT1b, and GQ1b, and of the tumor-associated gangliosides GM2 and GD2. The fatty acid moieties were incorporated after selective chemical or enzymatic deacylation of bovine brain gangliosides. For modification of the sphingoid bases, we developed a new synthetic method based on olefin cross metathesis. This method was used for the preparation of a lyso-GM1 and a lyso-GM2 standard. The total yield of this method was 8.7% for the synthesis of d17:1-lyso-GM1 from d20:1/18:0-GM1 in four steps. The title compounds are currently used as calibration substances for MS quantification and are also suitable for functional studies. Copyright © 2014 by the American Society for Biochemistry and Molecular Biology, Inc.

  18. 40 CFR 60.4203 - How long must my engines meet the emission standards if I am a stationary CI internal combustion...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... emission standards if I am a stationary CI internal combustion engine manufacturer? 60.4203 Section 60.4203... Combustion Engines Emission Standards for Manufacturers § 60.4203 How long must my engines meet the emission standards if I am a stationary CI internal combustion engine manufacturer? Engines manufactured by...

  19. 40 CFR 60.4203 - How long must my engines meet the emission standards if I am a stationary CI internal combustion...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... emission standards if I am a stationary CI internal combustion engine manufacturer? 60.4203 Section 60.4203... Combustion Engines Emission Standards for Manufacturers § 60.4203 How long must my engines meet the emission standards if I am a stationary CI internal combustion engine manufacturer? Engines manufactured by...

  20. Reflections on International Bibliographic Standards.

    ERIC Educational Resources Information Center

    Roberts, W.

    This paper raises questions about many bibliographic standards developed over the past 20 years, and challenges librarians to consider how standards might evolve. A brief overview is given of the aims of Universal Bibliographic Control (UBC) and to some assumptions common to much standardization work in recent years inspired by the concept of UBC.…

  1. Genomic Sequence of the WHO International Standard for Hepatitis A Virus RNA.

    PubMed

    Jenkins, Adrian; Minhas, Rehan; Morris, Clare; Berry, Neil

    2018-05-10

    The World Health Organization (WHO) international standard for hepatitis A virus (HAV) RNA nucleic acid assays was characterized by complete genome sequencing. The entire coding sequence and noncoding regions were assigned HAV genotype IB. This information will aid the design, development, and evaluation of HAV RNA amplification assays. Copyright © 2018 Jenkins et al.

  2. An evaluation of the relative safety of U.S. mining explosion-protected equipment approval requirements versus international standards

    PubMed Central

    Calder, W.; Snyder, D.; Burr, J.F.

    2018-01-01

    This paper provides a determination of the equivalent level of protection of the international standards relative to similar criteria used by the U.S. Mine Safety and Health Administration (MSHA) to approve two-fault intrinsically safe (IS) stand-alone equipment. U.S. mining law requires such a determination for MSHA to use alternatives to existing standards. The primary issue is to demonstrate that the international standards for equipment evaluation will provide at least the same level of protection for miners as the document currently used by MSHA. PMID:29780219

  3. Chinese regulation of off-label use of drugs.

    PubMed

    Ma, Feng; Lou, Nan

    2013-01-01

    China has significant gaps and weaknesses in its regulatory oversight of the off-label use of drugs. As in the United States, the off-label prescribing of drugs is not prohibited in China if there is a sound scientific basis. Physicians are allowed to prescribe off-label drugs based on their medical judgment if they follow certain requirements. There is some constraint on the right to prescribe by the imposition of malpractice liability if patients are harmed from improper off-label prescribing. However, damages awarded to successful plaintiffs are usually insignificant compared to malpractice damage awards in the U.S. Advertisement of off-label use is prohibited in China. All drug advertisements in China are subject to pre-approval, and must be based on information included in the approved package insert. However, the term "advertisement" is poorly defined. As a result, non-advertisement promotion of drugs for on-label or off-label use exist in a unregulated gray area. To better address the problem of inappropriate off-label promotion and use, China should (i) regulate both drug advertisements and non-advertisement promotion under a standard requiring off-label use to have a sound scientific basis, (ii) introduce harsher regulatory penalties, and (iii) increase compensation available for victims of medical malpractice. Such reform would not only discourage improper off-label use by introducing penalties (or increasing existing penalties) for improper promotion, but would also provide reasonable compensation for victims harmed by off-label use.

  4. International Space Station medical standards and certification for space flight participants.

    PubMed

    Bogomolov, Valery V; Castrucci, Filippo; Comtois, Jean-Marc; Damann, Volker; Davis, Jeffrey R; Duncan, J Michael; Johnston, Smith L; Gray, Gary W; Grigoriev, Anatoly I; Koike, Yu; Kuklinski, Paul; Matveyev, Vladimir P; Morgun, Valery V; Pochuev, Vladimir I; Sargsyan, Ashot E; Shimada, Kazuhito; Straube, Ulrich; Tachibana, Shoichi; Voronkov, Yuri V; Williams, Richard S

    2007-12-01

    The medical community of the International Space Station (ISS) has developed joint medical standards and evaluation requirements for Space Flight Participants ("space tourists") which are used by the ISS medical certification board to determine medical eligibility of individuals other than professional astronauts (cosmonauts) for short-duration space flight to the ISS. These individuals are generally fare-paying passengers without operational responsibilities. By means of this publication, the medical standards and evaluation requirements for the ISS Space Flight Participants are offered to the aerospace medicine and commercial spaceflight communities for reference purposes. It is emphasized that the criteria applied to the ISS spaceflight participant candidates are substantially less stringent than those for professional astronauts and/or crewmembers of visiting and long-duration missions to the ISS. These medical standards are released by the government space agencies to facilitate the development of robust medical screening and medical risk assessment approaches in the context of the evolving commercial human spaceflight industry.

  5. 21 CFR 350.50 - Labeling of antiperspirant drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... following: “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness”]. (2) The labeling may state “also...: ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”. (3) For products that demonstrate standard effectiveness (20 percent sweat reduction) over a 24-hour period, the labeling may state...

  6. 21 CFR 350.50 - Labeling of antiperspirant drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... following: “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness”]. (2) The labeling may state “also...: ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”. (3) For products that demonstrate standard effectiveness (20 percent sweat reduction) over a 24-hour period, the labeling may state...

  7. 21 CFR 350.50 - Labeling of antiperspirant drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... following: “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness”]. (2) The labeling may state “also...: ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”. (3) For products that demonstrate standard effectiveness (20 percent sweat reduction) over a 24-hour period, the labeling may state...

  8. 21 CFR 350.50 - Labeling of antiperspirant drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... following: “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness”]. (2) The labeling may state “also...: ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”. (3) For products that demonstrate standard effectiveness (20 percent sweat reduction) over a 24-hour period, the labeling may state...

  9. 21 CFR 350.50 - Labeling of antiperspirant drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... following: “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness”]. (2) The labeling may state “also...: ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”. (3) For products that demonstrate standard effectiveness (20 percent sweat reduction) over a 24-hour period, the labeling may state...

  10. Ideal regularization for learning kernels from labels.

    PubMed

    Pan, Binbin; Lai, Jianhuang; Shen, Lixin

    2014-08-01

    In this paper, we propose a new form of regularization that is able to utilize the label information of a data set for learning kernels. The proposed regularization, referred to as ideal regularization, is a linear function of the kernel matrix to be learned. The ideal regularization allows us to develop efficient algorithms to exploit labels. Three applications of the ideal regularization are considered. Firstly, we use the ideal regularization to incorporate the labels into a standard kernel, making the resulting kernel more appropriate for learning tasks. Next, we employ the ideal regularization to learn a data-dependent kernel matrix from an initial kernel matrix (which contains prior similarity information, geometric structures, and labels of the data). Finally, we incorporate the ideal regularization to some state-of-the-art kernel learning problems. With this regularization, these learning problems can be formulated as simpler ones which permit more efficient solvers. Empirical results show that the ideal regularization exploits the labels effectively and efficiently. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. The effect of column purification on cDNA indirect labelling for microarrays

    PubMed Central

    Molas, M Lia; Kiss, John Z

    2007-01-01

    Background The success of the microarray reproducibility is dependent upon the performance of standardized procedures. Since the introduction of microarray technology for the analysis of global gene expression, reproducibility of results among different laboratories has been a major problem. Two of the main contributors to this variability are the use of different microarray platforms and different laboratory practices. In this paper, we address the latter question in terms of how variation in one of the steps of a labelling procedure affects the cDNA product prior to microarray hybridization. Results We used a standard procedure to label cDNA for microarray hybridization and employed different types of column chromatography for cDNA purification. After purifying labelled cDNA, we used the Agilent 2100 Bioanalyzer and agarose gel electrophoresis to assess the quality of the labelled cDNA before its hybridization onto a microarray platform. There were major differences in the cDNA profile (i.e. cDNA fragment lengths and abundance) as a result of using four different columns for purification. In addition, different columns have different efficiencies to remove rRNA contamination. This study indicates that the appropriate column to use in this type of protocol has to be experimentally determined. Finally, we present new evidence establishing the importance of testing the method of purification used during an indirect labelling procedure. Our results confirm the importance of assessing the quality of the sample in the labelling procedure prior to hybridization onto a microarray platform. Conclusion Standardization of column purification systems to be used in labelling procedures will improve the reproducibility of microarray results among different laboratories. In addition, implementation of a quality control check point of the labelled samples prior to microarray hybridization will prevent hybridizing a poor quality sample to expensive micorarrays. PMID:17597522

  12. The effect of column purification on cDNA indirect labelling for microarrays.

    PubMed

    Molas, M Lia; Kiss, John Z

    2007-06-27

    The success of the microarray reproducibility is dependent upon the performance of standardized procedures. Since the introduction of microarray technology for the analysis of global gene expression, reproducibility of results among different laboratories has been a major problem. Two of the main contributors to this variability are the use of different microarray platforms and different laboratory practices. In this paper, we address the latter question in terms of how variation in one of the steps of a labelling procedure affects the cDNA product prior to microarray hybridization. We used a standard procedure to label cDNA for microarray hybridization and employed different types of column chromatography for cDNA purification. After purifying labelled cDNA, we used the Agilent 2100 Bioanalyzer and agarose gel electrophoresis to assess the quality of the labelled cDNA before its hybridization onto a microarray platform. There were major differences in the cDNA profile (i.e. cDNA fragment lengths and abundance) as a result of using four different columns for purification. In addition, different columns have different efficiencies to remove rRNA contamination. This study indicates that the appropriate column to use in this type of protocol has to be experimentally determined. Finally, we present new evidence establishing the importance of testing the method of purification used during an indirect labelling procedure. Our results confirm the importance of assessing the quality of the sample in the labelling procedure prior to hybridization onto a microarray platform. Standardization of column purification systems to be used in labelling procedures will improve the reproducibility of microarray results among different laboratories. In addition, implementation of a quality control check point of the labelled samples prior to microarray hybridization will prevent hybridizing a poor quality sample to expensive micorarrays.

  13. Microgravity Science Glovebox - Labels

    NASA Technical Reports Server (NTRS)

    1997-01-01

    Labels are overlaid on a photo (0003837) of the Microgravity Science Glovebox (MSG). The MSG is being developed by the European Space Agency (ESA) and NASA are developing the MSG for use aboard the International Space Station (ISS). Scientists will use the MSG to carry out multidisciplinary studies in combustion science, fluid physics and materials science. The MSG is managed by NASA's Marshall Space Flight Center (MSFC). Photo Credit: NASA/MSFC

  14. 40 CFR 1042.135 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... EMISSIONS FROM NEW AND IN-USE MARINE COMPRESSION-IGNITION ENGINES AND VESSELS Emission Standards and Related Requirements § 1042.135 Labeling. (a) Assign each engine a unique identification number and permanently affix, engrave, or stamp it on the engine in a legible way. (b) At the time of manufacture, affix a permanent and...

  15. Processes in the development of international specialist competencies and standards: the Sports Physiotherapy for All Project.

    PubMed

    Bulley, Catherine; Donaghy, Marie

    2008-01-01

    In a world of rapidly developing knowledge it is important that professions describe their roles and capabilities. The need for a thorough description of sports physiotherapy was addressed through collaboration between the International Federation of Sports Physiotherapy (IFSP) and five European higher education institutions. This resulted in the Sports Physiotherapy for All Project, which has been successful in developing internationally accepted competencies and standards for sports physiotherapists. This article describes and reflects on the process to communicate useful lessons. A competency model was chosen to facilitate differentiation and communication of aspects of sports physiotherapy practice. Documentation relating to sports physiotherapy practice was collected from 16 countries and analysed thematically. A cut and paste method was used by a panel of experts to allocate themes to areas of practice within the competency model. Theme groups were used to select areas of practice for description in competency form. Standards were derived from competencies following in depth discussion with the expert panel, and triangulation with themes derived from international documentation. A rigorous process of international review and revision led to the final list of 11 competencies and related standards, both accepted by the IFSP. This work provides a foundation for the development of an audit toolkit to guide demonstration and evaluation of competencies and standards. This provides a foundation for targeted career development activities, appropriate provision of training opportunities, and quality enhancement. The experiences gained during this project can inform other health professions and their specialisms when embarking on a similar journey.

  16. Taking the Lead in Science Education: Forging Next-Generation Science Standards. International Science Benchmarking Report. Appendix

    ERIC Educational Resources Information Center

    Achieve, Inc., 2010

    2010-01-01

    This appendix accompanies the report "Taking the Lead in Science Education: Forging Next-Generation Science Standards. International Science Benchmarking Report," a study conducted by Achieve to compare the science standards of 10 countries. This appendix includes the following: (1) PISA and TIMSS Assessment Rankings; (2) Courses and…

  17. International Society for the Advancement of Cytometry cell sorter biosafety standards.

    PubMed

    Holmes, Kevin L; Fontes, Benjamin; Hogarth, Philip; Konz, Richard; Monard, Simon; Pletcher, Charles H; Wadley, Robert B; Schmid, Ingrid; Perfetto, Stephen P

    2014-05-01

    Flow cytometric cell sorting of biological specimens has become prevalent in basic and clinical research laboratories. These specimens may contain known or unknown infectious agents, necessitating precautions to protect instrument operators and the environment from biohazards arising from the use of sorters. To this end the International Society of Analytical Cytology (ISAC) was proactive in establishing biosafety guidelines in 1997 (Schmid et al., Cytometry 1997;28:99-117) and subsequently published revised biosafety standards for cell sorting of unfixed samples in 2007 (Schmid et al., Cytometry Part A J Int Soc Anal Cytol 2007;71A:414-437). Since their publication, these documents have become recognized worldwide as the standard of practice and safety precautions for laboratories performing cell sorting experiments. However, the field of cytometry has progressed since 2007, and the document requires an update. The new Standards provides guidance: (1) for laboratory design for cell sorter laboratories; (2) for the creation of laboratory or instrument specific Standard Operating Procedures (SOP); and (3) on procedures for the safe operation of cell sorters, including personal protective equipment (PPE) and validation of aerosol containment. Published © 2014 Wiley Periodicals Inc.

  18. International Society for the Advancement of Cytometry Cell Sorter Biosafety Standards

    PubMed Central

    Holmes, Kevin L.; Fontes, Benjamin; Hogarth, Philip; Konz, Richard; Monard, Simon; Pletcher, Charles H.; Wadley, Robert B.; Schmid, Ingrid; Perfetto, Stephen P.

    2014-01-01

    Flow cytometric cell sorting of biological specimens has become prevalent in basic and clinical research laboratories. These specimens may contain known or unknown infectious agents, necessitating precautions to protect instrument operators and the environment from biohazards arising from the use of sorters. To this end the International Society of Analytical Cytology (ISAC) was proactive in establishing biosafety guidelines in 1997 (Schmid et al., Cytometry 1997;28:99–117) and subsequently published revised biosafety standards for cell sorting of unfixed samples in 2007 (Schmid et al., Cytometry Part A J Int Soc Anal Cytol 2007;71A:414–437). Since their publication, these documents have become recognized worldwide as the standard of practice and safety precautions for laboratories performing cell sorting experiments. However, the field of cytometry has progressed since 2007, and the document requires an update. The new Standards provides guidance: (1) for laboratory design for cell sorter laboratories; (2) for the creation of laboratory or instrument specific Standard Operating Procedures (SOP); and (3) on procedures for the safe operation of cell sorters, including personal protective equipment (PPE) and validation of aerosol containment. PMID:24634405

  19. Fluorescein isothiocyanate-labeled human plasma fibronectin in extracellular matrix remodeling.

    PubMed

    Hoffmann, Celine; Leroy-Dudal, Johanne; Patel, Salima; Gallet, Olivier; Pauthe, Emmanuel

    2008-01-01

    Fluorescein isothiocyanate (FITC) is a well-known probe for labeling biologically relevant proteins. However, the impact of the labeling procedure on protein structure and biological activities remains unclear. In this work, FITC-labeled human plasma fibronectin (Fn) was developed to gain insight into the dynamic relationship between cells and Fn. The similarities and differences concerning the structure and function between Fn-FITC and standard Fn were evaluated using biochemical as well as cellular approaches. By varying the FITC/Fn ratio, we demonstrated that overlabeling (>10 FITC molecules/Fn molecule) induces probe fluorescence quenching, protein aggregation, and cell growth modifications. A correct balance between reliable fluorescence for detection and no significant modifications to structure and biological function compared with standard Fn was obtained with a final ratio of 3 FITC molecules per Fn molecule (Fn-FITC3). Fn-FITC3, similar to standard Fn, is correctly recruited into the cell matrix network. Also, Fn-FITC3 is proposed to be a powerful molecular tool to investigate Fn organization and cellular behavior concomitantly.

  20. Influence of simplified nutrition labeling and taxation on laboratory energy intake in adults.

    PubMed

    Temple, Jennifer L; Johnson, Karena M; Archer, Kelli; Lacarte, Allison; Yi, Christina; Epstein, Leonard H

    2011-08-01

    The purpose of these studies was to test the hypotheses that simplified nutrition labeling and taxation alter food selection and intake. In Experiment 1, participants consumed lunch in the laboratory three times with no labels, standard nutrition labels, or traffic light diet labels at each visit. In Experiment 2, participants were given $6.00 with which to purchase lunch in the laboratory twice with standard pricing on one visit and a 25% tax on "red" foods on another visit. Participants received a brief education session on the labeling systems being used. Total energy intake and energy intake and number of foods purchased from each traffic light category were measured. Nutrition labeling decreased energy intake in lean females, but had no effect in men or in obese females. Traffic light labels increased consumption of "green" foods and decreased consumption of "red" foods. Taxation decreased the purchasing of "red" foods in obese, but not non-obese participants. There were no interactions between taxation and simplified nutrition labeling. Although generalization to real-world purchasing and consumption is limited by the laboratory study design, our findings suggests that taking multiple, simultaneous approaches to reduce energy intake may have the greatest impact on food purchases and/or nutrient consumption. Copyright © 2011 Elsevier Ltd. All rights reserved.

  1. Electron Detachment Dissociation (EDD) of Fluorescently Labeled Sialylated Oligosaccharides

    PubMed Central

    Zhou, Wen; Håkansson, Kristina

    2012-01-01

    We explored the application of electron detachment dissociation (EDD) and infrared multiphoton dissociation (IRMPD) tandem mass spectrometry to fluorescently labeled sialylated oligosaccharides. Standard sialylated oligosaccharides and a sialylated N-linked glycan released from human transferrin were investigated. EDD yielded extensive glycosidic cleavages and cross-ring cleavages in all cases studied, consistently providing complementary structural information compared to IRMPD. Neutral losses and satellite ions such as C – 2H ions were also observed following EDD. In addition, we examined the influence of different fluorescent labels. The acidic label 2-aminobenzoic acid (2-AA) enhanced signal abundance in negative-ion mode. However, few cross-ring fragments were observed for 2-AA labeled oligosaccharides. The neutral label 2-aminobenzamide (2-AB) resulted in more cross-ring cleavages compared to 2-AA labeled species, but not as extensive fragmentation as for native oligosaccharides, likely resulting from altered negative charge locations from introduction of the fluorescent tag. PMID:22120881

  2. Selected Lessons Learned over the ISS Design, Development, Assembly, and Operations: Applicability to International Cooperation for Standardization

    NASA Technical Reports Server (NTRS)

    Hirsch, David B.

    2010-01-01

    This slide presentation reviews some of the lessons learned in the sphere of international cooperation during the development, assembly and operation of the International Space Station. From the begining all Partners shared a common objective to build, operate and utilize a crewed laboratory in low orbit as an international partnership. The importance of standards is emphasized.

  3. Evolution of activities in international biological standardization since the early days of the Health Organisation of the League of Nations.

    PubMed

    Sizaret, P

    1988-01-01

    The main activities in international biological standardization during the 18 years that followed the first international biological standardization meeting in London in 1921 were concerned with expressing the potencies of test preparations in comparison with reference materials. After the Second World War, however, it became clear that the testing of biological substances against international reference materials was only one among several measures for obtaining safe and potent products. The activities in international biological standardization were therefore widened so that, by the strict observance of specific manufacturing and control requirements, it was possible to gain further in safety and efficacy. At the end of 1987, 42 international requirements for biological substances were available and were being used as national requirements, sometimes after minor modification, by the majority of WHO's Member States. This is of utmost importance for the worldwide use of safe and potent biological products, including vaccines.

  4. 21 CFR 660.35 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... red blood cell concentration is less than 2 percent, the variance shall be no more than ±0.5... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Reagent Red Blood Cells § 660.35 Labeling. In... of red blood cells in the suspension either as a discrete figure with a variance of more than ±1...

  5. 21 CFR 660.35 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... red blood cell concentration is less than 2 percent, the variance shall be no more than ±0.5... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Reagent Red Blood Cells § 660.35 Labeling. In... of red blood cells in the suspension either as a discrete figure with a variance of more than ±1...

  6. 21 CFR 660.35 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... red blood cell concentration is less than 2 percent, the variance shall be no more than ±0.5... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Reagent Red Blood Cells § 660.35 Labeling. In... of red blood cells in the suspension either as a discrete figure with a variance of more than ±1...

  7. 21 CFR 660.35 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... red blood cell concentration is less than 2 percent, the variance shall be no more than ±0.5... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Reagent Red Blood Cells § 660.35 Labeling. In... of red blood cells in the suspension either as a discrete figure with a variance of more than ±1...

  8. 21 CFR 640.70 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.70 Labeling. (a) In addition to the... container of Source Plasma: (1) The proper name of the product. (2) The statement “Caution: For... size and type of print as the proper name. If the Source Plasma has a reactive screening test for...

  9. 21 CFR 640.70 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.70 Labeling. (a) In addition to the... container of Source Plasma: (1) The proper name of the product. (2) The statement “Caution: For... size and type of print as the proper name. If the Source Plasma has a reactive screening test for...

  10. 7 CFR 201.74 - Labeling of all classes of certified seed.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Labeling of all classes of certified seed. 201.74... SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Certified Seed § 201.74 Labeling of all classes of certified seed. (a...

  11. 7 CFR 201.74 - Labeling of all classes of certified seed.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Labeling of all classes of certified seed. 201.74... SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Certified Seed § 201.74 Labeling of all classes of certified seed. (a...

  12. Progress, innovation and regulatory science in drug development: the politics of international standard-setting.

    PubMed

    Abraham, John; Reed, Tim

    2002-06-01

    This paper examines international standard-setting in the toxicology of pharmaceuticals during the 1990s, which has involved both the pharmaceutical industry and regulatory agencies in an organization known as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The analysis shows that the relationships between innovation, regulatory science and 'progress' may be more complex and controversial than is often assumed. An assessment of the ICH's claims about the implications of 'technical' harmonization of drug-testing standards for the maintenance of drug safety, via toxicological testing, and the delivery of therapeutic progress, via innovation, is presented. By demonstrating that there is not a technoscientific validity for these claims, it is argued that, within the ICH, a discourse of technological innovation and scientific progress has been used by regulatory agencies and prominent parts of the transnational pharmaceutical industry to legitimize the lowering and loosening of toxicological standards for drug testing. The mobilization and acceptance of this discourse are shown to be pivotal to the ICH's transformation of reductions in safety standards, which are apparently against the interests of patients and public health, into supposed therapeutic benefits derived from promises of greater access to more innovative drug products. The evidence suggests that it is highly implausible that these reductions in the standards of regulatory toxicology are consistent with therapeutic progress for patients, and highlights a worrying aspect embedded in the 'technical trajectories' of regulatory science.

  13. 40 CFR 60.4202 - What emission standards must I meet for emergency engines if I am a stationary CI internal...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... emergency engines if I am a stationary CI internal combustion engine manufacturer? 60.4202 Section 60.4202... Combustion Engines Emission Standards for Manufacturers § 60.4202 What emission standards must I meet for emergency engines if I am a stationary CI internal combustion engine manufacturer? (a) Stationary CI...

  14. World Health Organization International Standard to harmonize assays for detection of hepatitis E virus RNA.

    PubMed

    Baylis, Sally A; Blümel, Johannes; Mizusawa, Saeko; Matsubayashi, Keiji; Sakata, Hidekatsu; Okada, Yoshiaki; Nübling, C Micha; Hanschmann, Kay-Martin O

    2013-05-01

    Nucleic acid amplification technique-based assays are a primary method for the detection of acute hepatitis E virus (HEV) infection, but assay sensitivity can vary widely. To improve interlaboratory results for the detection and quantification of HEV RNA, a candidate World Health Organization (WHO) International Standard (IS) strain was evaluated in a collaborative study involving 23 laboratories from 10 countries. The IS, code number 6329/10, was formulated by using a genotype 3a HEV strain from a blood donation, diluted in pooled human plasma and lyophilized. A Japanese national standard, representing a genotype 3b HEV strain, was prepared and evaluated in parallel. The potencies of the standards were determined by qualitative and quantitative assays. Assay variability was substantially reduced when HEV RNA concentrations were expressed relative to the IS. Thus, WHO has established 6329/10 as the IS for HEV RNA, with a unitage of 250,000 International Units per milliliter.

  15. Distribution in Rats Internal Organs of Intraperitoneally Given 125I-Labeled Heptapeptide [2-8]-Leucopyrokinin ([2-8]-LPK), a Truncated Analog of Insect Neuropeptide Leucopyrokinin.

    PubMed

    Ryszka, Florian; Dolińska, Barbara; Suszka-Świtek, Aleksandra; Rykaczewska-Czerwińska, Monika; Konopińska, Danuta; Kuczer, Mariola; Plech, Andrzej

    2015-01-01

    It was previously found that synthetic, insect-derived octapeptide leucopyrokinin (LPK) applied directly into the lateral brain ventricle induced a significant antinociceptive effect in rats. Its synthetic truncated analog heptapeptide [2-8]-leucopyrokinin displayed a stronger antinociceptive effect in comparison to native LPK. Moreover it was previously found a high accumulation of these both 125I-labeled peptides in adrenals, as well as in hypothalamus and in hippocampus of rats brain. The aim of the present study was to assess the distribution of 125I-labeled [2-8]-leucopyrokinin in rats' internal organs an in several parts of the brain after peripheral - intraperitoneal (i.p.) administration. The study was performed on male Wistar rats. A synthetic [2-8]-leucopyrokinin ([2-8]-LPK) was iodinated with Na125I. On the day of experiment a solution of 125I-[2-8]-LPK was i.p. injected and the next after 1 and 24 h animals were sacrificed by decapitation. Radioactivity levels in samples of parts of the brain and of internal organs were determined by counter Gamma Auto Count. A uniform, low accumulation 125I-[2-8]-LPK was found in evaluated samples of the brain and in internal organs. The results of the present study indicate a weak penetration into the brain and internal organs of intraperitoneally applied 125I-[2-8]-LPK in rats and correspond with previously determined weak biological effects of i.p. injected LPK and [2-8]-LPK.

  16. Evaluation of Vocational Services Provided to Jordanian Disabled People According to International Standards

    ERIC Educational Resources Information Center

    Al-Oweidi, Alia

    2015-01-01

    The purpose of the study is to evaluate the vocational rehabilitation services provided to people with disabilities according to international standards in Jordan. The sample of the study consisted of (56) managers and teachers in four specialized centers in vocational rehabilitation. The findings showed that the compatibility degree ranged…

  17. 76 FR 68829 - International Standards on the Transport of Dangerous Goods; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    .... PHMSA-2011-0246; Notice No. 11-11] International Standards on the Transport of Dangerous Goods; Public... of Experts on the Transport of Dangerous Goods (UNSCOE TDG) to be held November 28 to December 7... on the Transport of Dangerous Goods Model Regulations which will be implemented within relevant...

  18. [The revised Dutch College of General Practitioners' standard on COPD and the first international WHO standard: differences and similarities].

    PubMed

    van Schayck, C P

    2002-02-23

    Two standards on COPD have recently been published: the revised national standard from the Dutch College of General Practitioners and the first international standard published by the World Health Organization and the US National Heart, Lung and Blood Institute. The reduced emphasis on the role of spirometry in the monitoring and evaluation of treatment is an important change in these new standards compared to previous ones. Cessation of smoking is considered to be central to the prevention and treatment of COPD. Doctors should strongly support this approach and, more than before, are urged to view COPD as a disease caused by addiction. Bronchodilators are the cornerstone of symptomatic treatment of COPD, particularly the long-acting ones due to their ease of administration and effective treatment of morning dyspnoea. Inhalation corticosteroids should only be administered as a trial treatment and only under certain conditions. Continuation of treatment with these agents is only justified if there is a demonstrated improvement in lung function, exacerbations or symptoms, although the precise area of indication is not yet clear.

  19. Improving labeling efficiency in automatic quality control of MRSI data.

    PubMed

    Pedrosa de Barros, Nuno; McKinley, Richard; Wiest, Roland; Slotboom, Johannes

    2017-12-01

    To improve the efficiency of the labeling task in automatic quality control of MR spectroscopy imaging data. 28'432 short and long echo time (TE) spectra (1.5 tesla; point resolved spectroscopy (PRESS); repetition time (TR)= 1,500 ms) from 18 different brain tumor patients were labeled by two experts as either accept or reject, depending on their quality. For each spectrum, 47 signal features were extracted. The data was then used to run several simulations and test an active learning approach using uncertainty sampling. The performance of the classifiers was evaluated as a function of the number of patients in the training set, number of spectra in the training set, and a parameter α used to control the level of classification uncertainty required for a new spectrum to be selected for labeling. The results showed that the proposed strategy allows reductions of up to 72.97% for short TE and 62.09% for long TE in the amount of data that needs to be labeled, without significant impact in classification accuracy. Further reductions are possible with significant but minimal impact in performance. Active learning using uncertainty sampling is an effective way to increase the labeling efficiency for training automatic quality control classifiers. Magn Reson Med 78:2399-2405, 2017. © 2017 International Society for Magnetic Resonance in Medicine. © 2017 International Society for Magnetic Resonance in Medicine.

  20. Biosynthetic production of universally (13)C-labelled polyunsaturated fatty acids as reference materials for natural health product research.

    PubMed

    Le, Phuong Mai; Fraser, Catherine; Gardner, Graeme; Liang, Wei-Wan; Kralovec, Jaroslav A; Cunnane, Stephen C; Windust, Anthony J

    2007-09-01

    Long-chain polyunsaturated fatty acids (LCPUFA) including eicosapentaenoic acid (EPA, 20:5n-3) and docosahexaenoic acid (DHA, 22:6n-3) have become important natural health products with numerous proven benefits related to brain function and cardiovascular health. Not only are omega-3 fatty acids available in a plethora of dietary supplements, but they are also increasingly being incorporated as triglycerides into conventional foods, including bread, milk, yoghurt and confectionaries. Recently, transgenic oil seed crops and livestock have been developed that enhance omega-3 fatty acid content. This diverse array of matrices presents a difficult analytical challenge and is compounded further by samples generated through clinical research. Stable isotope (13)C-labelled LCPUFA standards offer many advantages as research tools because they may be distinguished from their naturally abundant counterparts by mass spectrometry and directly incorporated as internal standards into analytical procedures. Further, (13)C-labelled LCPUFAs are safe to use as metabolic tracers to study uptake and metabolism in humans. Currently, (13)C-labelled LCPUFAs are expensive, available in limited supply and not in triglyceride form. To resolve these issues, marine heterotrophic microorganisms are being isolated and screened for LCPUFA production with a view to the efficient biosynthetic production of U-(13)C-labelled fatty acids using U-(13)C glucose as a carbon source. Of 37 isolates obtained, most were thraustochytrids, and either DHA or omega-6 docosapentaenoic acid (22:5n-6) were produced as the major LCPUFA. The marine protist Hyalochlorella marina was identified as a novel source of EPA and omega-3 docosapentaenoic acid (22:5n-3). As proof of principle, gram-level production of (13)C-labelled DHA has been achieved with high chemical purity ( >99%) and high (13)C incorporation levels (>90%), as confirmed by NMR and MS analyses. Finally, U-(13)C-DHA was enzymatically re-esterified to