21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

Cross-platform comparison of nucleic acid hybridization: toward quantitative reference standards.

PubMed

Halvorsen, Ken; Agris, Paul F

2014-11-15

Measuring interactions between biological molecules is vitally important to both basic and applied research as well as development of pharmaceuticals. Although a wide and growing range of techniques is available to measure various kinetic and thermodynamic properties of interacting biomolecules, it can be difficult to compare data across techniques of different laboratories and personnel or even across different instruments using the same technique. Here we evaluate relevant biological interactions based on complementary DNA and RNA oligonucleotides that could be used as reference standards for many experimental systems. We measured thermodynamics of duplex formation using isothermal titration calorimetry, differential scanning calorimetry, and ultraviolet-visible (UV-vis) monitored denaturation/renaturation. These standards can be used to validate results, compare data from disparate techniques, act as a teaching tool for laboratory classes, or potentially to calibrate instruments. The RNA and DNA standards have many attractive features, including low cost, high purity, easily measurable concentrations, and minimal handling concerns, making them ideal for use as a reference material. Copyright © 2014 Elsevier Inc. All rights reserved.

Fibrinolysis standards: a review of the current status.

PubMed

Thelwell, C

2010-07-01

Biological standards are used to calibrate measurements of components of the fibrinolytic system, either for assigning potency values to therapeutic products, or to determine levels in human plasma as an indicator of thrombotic risk. Traditionally WHO International Standards are calibrated in International Units based on consensus values from collaborative studies. The International Unit is defined by the response activity of a given amount of the standard in a bioassay, independent of the method used. Assay validity is based on the assumption that both standard and test preparation contain the same analyte, and the response in an assay is a true function of this analyte. This principle is reflected in the diversity of source materials used to prepare fibrinolysis standards, which has depended on the contemporary preparations they were employed to measure. With advancing recombinant technology, and improved analytical techniques, a reference system based on reference materials and associated reference methods has been recommended for future fibrinolysis standards. Careful consideration and scientific judgement must however be applied when deciding on an approach to develop a new standard, with decisions based on the suitability of a standard to serve its purpose, and not just to satisfy a metrological ideal. 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

21 CFR 660.52 - Reference preparations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Reference preparations. 660.52 Section 660.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Anti-Human Globulin § 660.52 Reference...

Interlaboratory Study Characterizing a Yeast Performance Standard for Benchmarking LC-MS Platform Performance*

PubMed Central

Paulovich, Amanda G.; Billheimer, Dean; Ham, Amy-Joan L.; Vega-Montoto, Lorenzo; Rudnick, Paul A.; Tabb, David L.; Wang, Pei; Blackman, Ronald K.; Bunk, David M.; Cardasis, Helene L.; Clauser, Karl R.; Kinsinger, Christopher R.; Schilling, Birgit; Tegeler, Tony J.; Variyath, Asokan Mulayath; Wang, Mu; Whiteaker, Jeffrey R.; Zimmerman, Lisa J.; Fenyo, David; Carr, Steven A.; Fisher, Susan J.; Gibson, Bradford W.; Mesri, Mehdi; Neubert, Thomas A.; Regnier, Fred E.; Rodriguez, Henry; Spiegelman, Cliff; Stein, Stephen E.; Tempst, Paul; Liebler, Daniel C.

2010-01-01

Optimal performance of LC-MS/MS platforms is critical to generating high quality proteomics data. Although individual laboratories have developed quality control samples, there is no widely available performance standard of biological complexity (and associated reference data sets) for benchmarking of platform performance for analysis of complex biological proteomes across different laboratories in the community. Individual preparations of the yeast Saccharomyces cerevisiae proteome have been used extensively by laboratories in the proteomics community to characterize LC-MS platform performance. The yeast proteome is uniquely attractive as a performance standard because it is the most extensively characterized complex biological proteome and the only one associated with several large scale studies estimating the abundance of all detectable proteins. In this study, we describe a standard operating protocol for large scale production of the yeast performance standard and offer aliquots to the community through the National Institute of Standards and Technology where the yeast proteome is under development as a certified reference material to meet the long term needs of the community. Using a series of metrics that characterize LC-MS performance, we provide a reference data set demonstrating typical performance of commonly used ion trap instrument platforms in expert laboratories; the results provide a basis for laboratories to benchmark their own performance, to improve upon current methods, and to evaluate new technologies. Additionally, we demonstrate how the yeast reference, spiked with human proteins, can be used to benchmark the power of proteomics platforms for detection of differentially expressed proteins at different levels of concentration in a complex matrix, thereby providing a metric to evaluate and minimize preanalytical and analytical variation in comparative proteomics experiments. PMID:19858499

Standardization of allergen products: 2. Detailed characterization of GMP-produced recombinant Phl p 5.0109 as European Pharmacopoeia reference standard.

PubMed

Himly, M; Nandy, A; Kahlert, H; Thilker, M; Steiner, M; Briza, P; Neubauer, A; Klysner, S; van Ree, R; Buchheit, K-H; Vieths, S; Ferreira, F

2016-04-01

The Biological Standardization Programme of the European Directorate for Quality of Medicines and Healthcare (EDQM) aims at the establishment of well-characterized reference standards based on recombinant allergens and validated assays for the quantification of major allergen content. The objective of this study was to examine the detailed physicochemical and immunological characterization of recombinant Phl p 5.0109, the second available allergen reference standard. Recombinant Phl p 5.0109 PP5ar06007 was produced under GMP conditions and analyzed by an array of physicochemical and immunological methods for identity, quantity, homogeneity, and folding stability in bulk solution, as well as thermal denaturation, aggregation state, and biological activity when formulated for long-time storage. PP5ar06007 revealed as a highly homogeneous, monomeric, well-folded preparation of rPhl p 5.0109, as documented by mass spectrometry, SDS-PAGE, isoelectric focusing, size-exclusion chromatography with light scattering, circular dichroism, and infrared spectroscopy. Upon storage at +4°C, PP5ar06007 retained the monomeric state for at least 2 months. A protein quantity of 1.56 ± 0.03 mg/ml was determined by amino acid analysis in PP5ar06007, and its biological activity was shown to be comparable to natural Phl p 5 in terms of basophil activation and T-cell reactivity. Recombinant Phl p 5.0109 PP5ar06007 was characterized extensively at the physicochemical and immunological level. It revealed to be a highly stable, monomeric, and immunologically equivalent of its natural counterpart. PP5ar06007 is now available as European Pharmacopoeia allergen reference standard for grass pollen products. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Reference Standardization for Mass Spectrometry and High-resolution Metabolomics Applications to Exposome Research.

PubMed

Go, Young-Mi; Walker, Douglas I; Liang, Yongliang; Uppal, Karan; Soltow, Quinlyn A; Tran, ViLinh; Strobel, Frederick; Quyyumi, Arshed A; Ziegler, Thomas R; Pennell, Kurt D; Miller, Gary W; Jones, Dean P

2015-12-01

The exposome is the cumulative measure of environmental influences and associated biological responses throughout the lifespan, including exposures from the environment, diet, behavior, and endogenous processes. A major challenge for exposome research lies in the development of robust and affordable analytic procedures to measure the broad range of exposures and associated biologic impacts occurring over a lifetime. Biomonitoring is an established approach to evaluate internal body burden of environmental exposures, but use of biomonitoring for exposome research is often limited by the high costs associated with quantification of individual chemicals. High-resolution metabolomics (HRM) uses ultra-high resolution mass spectrometry with minimal sample preparation to support high-throughput relative quantification of thousands of environmental, dietary, and microbial chemicals. HRM also measures metabolites in most endogenous metabolic pathways, thereby providing simultaneous measurement of biologic responses to environmental exposures. The present research examined quantification strategies to enhance the usefulness of HRM data for cumulative exposome research. The results provide a simple reference standardization protocol in which individual chemical concentrations in unknown samples are estimated by comparison to a concurrently analyzed, pooled reference sample with known chemical concentrations. The approach was tested using blinded analyses of amino acids in human samples and was found to be comparable to independent laboratory results based on surrogate standardization or internal standardization. Quantification was reproducible over a 13-month period and extrapolated to thousands of chemicals. The results show that reference standardization protocol provides an effective strategy that will enhance data collection for cumulative exposome research. In principle, the approach can be extended to other types of mass spectrometry and other analytical methods. © The Author 2015. Published by Oxford University Press on behalf of the Society of Toxicology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Reference Standardization for Mass Spectrometry and High-resolution Metabolomics Applications to Exposome Research

PubMed Central

Go, Young-Mi; Walker, Douglas I.; Liang, Yongliang; Uppal, Karan; Soltow, Quinlyn A.; Tran, ViLinh; Strobel, Frederick; Quyyumi, Arshed A.; Ziegler, Thomas R.; Pennell, Kurt D.; Miller, Gary W.; Jones, Dean P.

2015-01-01

The exposome is the cumulative measure of environmental influences and associated biological responses throughout the lifespan, including exposures from the environment, diet, behavior, and endogenous processes. A major challenge for exposome research lies in the development of robust and affordable analytic procedures to measure the broad range of exposures and associated biologic impacts occurring over a lifetime. Biomonitoring is an established approach to evaluate internal body burden of environmental exposures, but use of biomonitoring for exposome research is often limited by the high costs associated with quantification of individual chemicals. High-resolution metabolomics (HRM) uses ultra-high resolution mass spectrometry with minimal sample preparation to support high-throughput relative quantification of thousands of environmental, dietary, and microbial chemicals. HRM also measures metabolites in most endogenous metabolic pathways, thereby providing simultaneous measurement of biologic responses to environmental exposures. The present research examined quantification strategies to enhance the usefulness of HRM data for cumulative exposome research. The results provide a simple reference standardization protocol in which individual chemical concentrations in unknown samples are estimated by comparison to a concurrently analyzed, pooled reference sample with known chemical concentrations. The approach was tested using blinded analyses of amino acids in human samples and was found to be comparable to independent laboratory results based on surrogate standardization or internal standardization. Quantification was reproducible over a 13-month period and extrapolated to thousands of chemicals. The results show that reference standardization protocol provides an effective strategy that will enhance data collection for cumulative exposome research. In principle, the approach can be extended to other types of mass spectrometry and other analytical methods. PMID:26358001

Cross-platform comparison of nucleic acid hybridization: toward quantitative reference standardsa

PubMed Central

Halvorsen, Ken; Agris, Paul F.

2014-01-01

Measuring interactions between biological molecules is vitally important to both basic and applied research, as well as development of pharmaceuticals. While a wide and growing range of techniques are available to measure various kinetic and thermodynamic properties of interacting biomolecules, it can be difficult to compare data across techniques of different laboratories and personnel, or even across different instruments using the same technique. Here we evaluate relevant biological interactions based on complementary DNA and RNA oligonucleotides that could be used as reference standards for many experimental systems. We measured thermodynamics of duplex formation using Isothermal Titration Calorimetry, Differential Scanning Calorimetry, and UV-Vis monitored denaturation/renaturation. These standards can be used to validate results, compare data from disparate techniques, act as a teaching tool for laboratory classes, or potentially to calibrate instruments. The RNA and DNA standards have many attractive features including low cost, high purity, easily measureable concentrations, and minimal handling concerns, making them ideal for use as a reference material. PMID:25124363

42 CFR 7.5 - Payment procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Payment procedures. 7.5 Section 7.5 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL PREPARATIONS § 7.5 Payment procedures. The requester may...

Recommendations for designing and conducting veterinary clinical pathology biologic variation studies.

PubMed

Freeman, Kathleen P; Baral, Randolph M; Dhand, Navneet K; Nielsen, Søren Saxmose; Jensen, Asger L

2017-06-01

The recent creation of a veterinary clinical pathology biologic variation website has highlighted the need to provide recommendations for future studies of biologic variation in animals in order to help standardize and improve the quality of published information and to facilitate review and selection of publications as standard references. The following recommendations are provided in the format and order commonly found in veterinary publications. A checklist is provided to aid in planning, implementing, and evaluating veterinary studies on biologic variation (Appendix S1). These recommendations provide a valuable resource for clinicians, laboratorians, and researchers interested in conducting studies of biologic variation and in determining the quality of studies of biologic variation in veterinary laboratory testing. © 2017 American Society for Veterinary Clinical Pathology.

Determination of perfluorinated alkyl acid concentrations in biological standard reference materials.

PubMed

Reiner, Jessica L; O'Connell, Steven G; Butt, Craig M; Mabury, Scott A; Small, Jeff M; De Silva, Amila O; Muir, Derek C G; Delinsky, Amy D; Strynar, Mark J; Lindstrom, Andrew B; Reagen, William K; Malinsky, Michelle; Schäfer, Sandra; Kwadijk, Christiaan J A F; Schantz, Michele M; Keller, Jennifer M

2012-11-01

Standard reference materials (SRMs) are homogeneous, well-characterized materials used to validate measurements and improve the quality of analytical data. The National Institute of Standards and Technology (NIST) has a wide range of SRMs that have mass fraction values assigned for legacy pollutants. These SRMs can also serve as test materials for method development, method validation, and measurement for contaminants of emerging concern. Because inter-laboratory comparison studies have revealed substantial variability of measurements of perfluoroalkyl acids (PFAAs), future analytical measurements will benefit from determination of consensus values for PFAAs in SRMs to provide a means to demonstrate method-specific performance. To that end, NIST, in collaboration with other groups, has been measuring concentrations of PFAAs in a variety of SRMs. Here we report levels of PFAAs and perfluorooctane sulfonamide (PFOSA) determined in four biological SRMs: fish tissue (SRM 1946 Lake Superior Fish Tissue, SRM 1947 Lake Michigan Fish Tissue), bovine liver (SRM 1577c), and mussel tissue (SRM 2974a). We also report concentrations for three in-house quality-control materials: beluga whale liver, pygmy sperm whale liver, and white-sided dolphin liver. Measurements in SRMs show an array of PFAAs, with perfluorooctane sulfonate (PFOS) being the most frequently detected. Reference and information values are reported for PFAAs measured in these biological SRMs.

Aerospace Medicine and Biology: A Continuing Bibliography With Indexes. Supplement 486

NASA Technical Reports Server (NTRS)

1999-01-01

In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract.

SETTING EXPECTATIONS FOR THE ECOLOGICAL CONDITION OF STREAMS: THE CONCEPT OF REFERENCE CONDITION

EPA Science Inventory

An important component of the biological assessment of stream condition is an evaluation of the direct or indirect effects of human activities or disturbances. The concept of a "reference condition" is increasingly used to describe the standard or benchmark against which current ...

CPTC and NIST-sponsored Yeast Reference Material Now Publicly Available | Office of Cancer Clinical Proteomics Research

Cancer.gov

The yeast protein extract (RM8323) developed by National Institute of Standards and Technology (NIST) under the auspices of NCI's CPTC initiative is currently available to the public at https://www-s.nist.gov/srmors/view_detail.cfm?srm=8323. The yeast proteome offers researchers a unique biological reference material. RM8323 is the most extensively characterized complex biological proteome and the only one associated with several large-scale studies to estimate protein abundance across a wide concentration range.

Evaluation of a fungal collection as certified reference material producer and as a biological resource center.

PubMed

Forti, Tatiana; Souto, Aline da S S; do Nascimento, Carlos Roberto S; Nishikawa, Marilia M; Hubner, Marise T W; Sabagh, Fernanda P; Temporal, Rosane Maria; Rodrigues, Janaína M; da Silva, Manuela

2016-01-01

Considering the absence of standards for culture collections and more specifically for biological resource centers in the world, in addition to the absence of certified biological material in Brazil, this study aimed to evaluate a Fungal Collection from Fiocruz, as a producer of certified reference material and as Biological Resource Center (BRC). For this evaluation, a checklist based on the requirements of ABNT ISO GUIA34:2012 correlated with the ABNT NBR ISO/IEC17025:2005, was designed and applied. Complementing the implementation of the checklist, an internal audit was performed. An evaluation of this Collection as a BRC was also conducted following the requirements of the NIT-DICLA-061, the Brazilian internal standard from Inmetro, based on ABNT NBR ISO/IEC 17025:2005, ABNT ISO GUIA 34:2012 and OECD Best Practice Guidelines for BRCs. This was the first time that the NIT DICLA-061 was applied in a culture collection during an internal audit. The assessments enabled the proposal for the adequacy of this Collection to assure the implementation of the management system for their future accreditation by Inmetro as a certified reference material producer as well as its future accreditation as a Biological Resource Center according to the NIT-DICLA-061. Copyright © 2016 Sociedade Brasileira de Microbiologia. Published by Elsevier Editora Ltda. All rights reserved.

[Research strategies in standard decoction of medicinal slices].

PubMed

Chen, Shi-Lin; Liu, An; Li, Qi; Toru, Sugita; Zhu, Guang-Wei; Sun, Yi; Dai, Yun-Tao; Zhang, Jun; Zhang, Tie-Jun; Takehisa, Tomoda; Liu, Chang-Xiao

2016-04-01

This paper discusses the research situation of the standard decoction of medicinal slices at home and abroad. Combined with the experimental data, the author proposes that the standard decoction of medicinal slices is made of single herb using standard process which should be guided by the theory of traditional Chinese medicine, based on clinical practice and referred to modern extraction method with a standard process. And the author also proposes the principles of establishing the specification of process parameters and quality standards and established the basis of drug efficacy material and biological reference. As a standard material and standard system, the standard decoction of medicinal slices can provide standards for clinical medication, standardize the use of the new type of medicinal slices especially for dispensing granules, which were widely used in clinical. It can ensure the accuracy of drugs and consistency of dose, and to solve current supervision difficulties. Moreover the study of standard decoction of medicinal slices will provide the research on dispensing granules, traditional Chinese medicine prescription standard decoction and couplet medicines standard decoction a useful reference. Copyright© by the Chinese Pharmaceutical Association.

78 FR 43817 - Distribution of Reference Biological Standards and Biological Preparations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-22

... and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Direct final rule and request for comments. SUMMARY: The Centers for Disease Control and Prevention (CDC), located within the... for Disease Control and Prevention, 1600 Clifton Road, NE., MS C-17, Atlanta, Georgia 30333, ATTN...

[Diagnostic kits in parasitology: which controls?].

PubMed

Rossi, P

2004-06-01

The development of new diagnostic tools particularly for some parasitic "neglected diseases", is slowed or even hindered by limited resources assigned for basic and applied research in public institution and private sector. Even if the time-line and costs needed for developing a new In Vitro Diagnostic (IVD) test are generally lower compared to vaccines or new drugs, industry is poorly engaged in investing resources due to the perception of limited markets. To accelerate the development of diagnostics for the world's most deadly diseases, the World Health Organization's (WHO) Special Programme for Research and Training in Tropical Diseases (TDR), the United Nations Development Programme, the World Bank and the Gates Foundation, last year launched a new initiative, FIND (Foundation for Innovative New Diagnostics, www.finddiagnostics.org). The aim is to "apply the latest biotechnology innovations to develop and validate affordable diagnostic tests for diseases of the developing world". Ideally, a new diagnostic test should be accurately evaluated prior to use in medical practice. The first step would be a pre-clinical evaluation, an analytic study to determine its laboratory performance. A crucial point in this phase is the calibration of reagents (antigens, antibodies, DNA probes, etc.) against a standard reference preparation. WHO, through the WHO International Laboratories for Biological Standards, "provides International Biological Reference Preparations which serve as reference sources of defined biological activity expressed in an internationally agreed unit" (www.who.int/biologicals/IBRP/index.htm). Standardization allows "comparison of biological measurements worldwide" and ensures the reliability of diagnostic procedures. These preparations are generally intended for use in the characterization of the activity of secondary reference preparations (regional, national or in-house working standards). Unfortunately, international reference standards for parasitic diseases are not available at present, except for Toxoplasma antibodies. The first international standard reagent for Anti-Toxoplasma Serum was established in 1968 and at present, an international standard reference serum, Anti-toxoplasma serum, human TOXM is available at the National Institute for Biological Standards and Control (NIBSC) in UK. Several collaborative, multicenter studies were carried out to assess the performance of different methods and commercial tests for the diagnosis of toxoplasmosis, by providing to participating laboratories a panel of well-defined sera to be tested. A four-phase process following well-accepted methodological standards for the development of diagnostics, analogous to those internationally accepted for drugs and vaccines was recently proposed. The pre-clinical evaluation, the analytic study to assess sensitivity, specificity, predictive values in laboratory (phase I), should be followed by a proof of principle study to distinguish diseased from healthy persons in easily accessible populations (phase II). The evaluation of test performance in populations of intended use (phase III), and finally the delineation of cost-effectiveness and societal impact of new tests in comparison with existing tools (phase IV) should complete the validation procedure. In this context, national regulatory agencies play a major role in pre-market approval and post-market surveillance of IVDs. The European Community in 1998 approved a directive (Directive 98/79/EC) which rules the marketing of IVD medical devices, in order to harmonise the performance levels and standards in European countries. But, among IVDs for parasitic diseases, only those to detect congenital toxoplasmosis are submitted to defined procedures to provide the verification of products before their placing on the market and the surveillance after their marketing by a notified body, which perform appropriate examinations, tests and inspections to production facilities to verify if the device meets the requirements of the directive. In U.S.A., the Food and Drug Administration (FDA), through the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), provides a comprehensive and regulatory activity for IVDs through pre-market evaluation and post-market surveillance. In developing countries, the scarcity of resources limits the procedures through which the national control authority can assure safety, quality and efficacy of products marketed, both imported and locally manufactured.

Standardization of the capillary electrophoresis procedures Capillarys® CDT and Minicap® CDT in comparison to the IFCC reference measurement procedure.

PubMed

Schellenberg, François; Humeau, Camille

2017-06-01

CDT is at present the most relevant routinely available biological marker of alcohol use and is widely used for screening and monitoring of patients. The lack of standardization leads to specific reference intervals for each procedure. The IFCC working group devoted to CDT demonstrated that the standardization is possible using calibrators assigned to the reference measurement procedure. In this study, we compare the capillary electrophoresis (CE) techniques Capillarys® CDT and Minicap® CDT (Sebia, Lisses, France) to the reference procedure before and after standardization in 126 samples covering the range of CDT measurement. Both capillary electrophoresis procedures show a high correlation (r=0,997) with the reference procedure and the concordance correlation coefficient evaluated according to Mc Bride is "almost perfect" (>0.997 for both CE procedures). The number of results with a relative difference higher than the acceptable difference limit is only 1 for Capillarys® CDT and 5 for Minicap® CDT. These results demonstrate the efficiency of the standardization of CDT measurements for both CE techniques from Sebia, achieved using calibrators assigned to the reference measurement procedure.

Overview on the standardization in the field of electromagnetic compatibility

NASA Astrophysics Data System (ADS)

Goldberg, Georges

1989-04-01

Standardization in the domain of electromagnetic compatibility (EMC) is discussed, with specific reference to the standards of the International Electrotechnical Commission, the Comite International Special des Perturbations Radioelectriques, and the Comite Europeen de Normalisation Electrotechnique. EMC fields considered include radiocommunications, telecommunications, biological effects, and data transmission. Standards are presented for such electromagnetic disturbances as low-frequency, high-frequency, conduction, and radiation phenomena.

Radiation Standards: The Last Word or at Least a Definitive One

ERIC Educational Resources Information Center

Gillette, Robert

1972-01-01

Discusses the report of the National Academy of Science Committee on the Biological Effects of Ionizing Radiation, with particular reference to the possibilities for lowering maximum permissible standards for exposure to man-made radiation. The excessive use of diagnostic X-rays is considered. (AL)

The use of a single multielement standard for trace analysis in biological materials by external beam PIXE

NASA Astrophysics Data System (ADS)

Biswas, S. K.; Khaliquzzaman, M.; Islam, M. M.; Khan, A. H.

1984-04-01

The validity of the use of a single multielement standard for mass calibration in thick-target external beam PIXE analysis of biological materials has been investigated. In this study, the NBS orchard leaf, SRM 1571, was used as the basic standard for trace element analysis in other biological materials. Using the present procedure, the concentrations of K, Ca, Mn, Fe, Ni, Cu, Zn, Br, Rb and Sr were determined in several NBS reference materials such as bovine liver, spinach, rice flour, etc., generally in 20 μC irradiations with 2.0 MeV protons. The analytical results are compared with certified values of the NBS as well as with other measurements and the sources of errors are discussed.

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population.

PubMed

Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

2016-03-26

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients' care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine.

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population

PubMed Central

Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

2016-01-01

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients’ care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine. PMID:27019800

Aerospace Medicine and Biology: A Continuing Bibliography. Supplement 476

NASA Technical Reports Server (NTRS)

1998-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1998-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract.

Determination of silicon in biological and botanical reference materials by epithermal INAA and Compton suppression

NASA Astrophysics Data System (ADS)

Landsberger, S.; Peshev, S.; Becker, D. A.

1994-12-01

Silicon determination in sixteen botanical and biological standard reference materials is described using the 29Si(n, p) 29Al reaction through instrumental epithermal neutron activation analysis and Compton suppression gamma-ray spectroscopy. By simultaneous utilization of both cadmium and boron epithermal filters along with anticoincidence gamma-counting, detection limits as low as 12 ppm were obtained for certain matrices, much lower than previously reported values for this type of analysis. The method is applicable to many botanical and biological matrices and is attractive with its interference free, purely instrumental nature, compared with methods using the 28Si(n, p) 28Al reaction or chemical separation techniques.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 488

NASA Technical Reports Server (NTRS)

1999-01-01

This report lists reports, articles and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 490

NASA Technical Reports Server (NTRS)

1999-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. Two indexes-subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 498

NASA Technical Reports Server (NTRS)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 487

NASA Technical Reports Server (NTRS)

1999-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. Two indexes-subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 482

NASA Technical Reports Server (NTRS)

1999-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract.

Aerospace Medicine and Biology: A Continuing Bibliography With Indexes. Supplement 502

NASA Technical Reports Server (NTRS)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-2000-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. Two indexes-subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 489

NASA Technical Reports Server (NTRS)

1999-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 477

NASA Technical Reports Server (NTRS)

1998-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1998-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 478

NASA Technical Reports Server (NTRS)

1998-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1998-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 504

NASA Technical Reports Server (NTRS)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-2000-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. Two indexes- subject and author are included after the abstract section.

Determination of Trace Level Iodine in Biological and Botanical Reference Materials by Isotope Dilution Mass Spectrometry

PubMed Central

Gramlich, John W.; Murphy, Thomas J.

1989-01-01

A method has been developed for the determination of trace level iodine in biological and botanical materials. The method consists of spiking a sample with 129I, equilibration of the spike with the natural iodine, wet ashing under carefully controlled conditions, and separation of the iodine by co-precipitation with silver chloride. Measurement of the 129I/127I ratio is accomplished by negative thermal ionization mass spectrometry using LaB6 for ionization enhancement. The application of the method to the certification of trace iodine in two Standard Reference Materials is described. PMID:28053411

Aerospace medicine and biology: A continuing bibliography with indexes, supplement 97

NASA Technical Reports Server (NTRS)

1972-01-01

Subject coverage concentrates on the biological, physiological, psychological, and environmental effects to which man is subjected during and following simulated or actual flight in the earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Each entry consists of a standard citation accompanied by its abstract.

Aerospace medicine and biology: A continuing bibliography with indexes (supplement 94)

NASA Technical Reports Server (NTRS)

1971-01-01

Subject coverage concentrates on the biological, physiological, psychological, and environmental effects to which man is subjected during and following simulated or actual flight in the earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Each entry consists of a standard citation accompanied by its abstract.

Aerospace medicine and biology: A continuing bibliography with indexes, supplement 96

NASA Technical Reports Server (NTRS)

1971-01-01

Subject coverage concentrates on the biological, physiological, psychological, and environmental effects to which man is subjected during and following simulated or actual flight in the earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Each entry consists of a standard citation accompanied by its abstract.

Aerospace medicine and biology: A continuing bibliography with indexes, supplement

NASA Technical Reports Server (NTRS)

1972-01-01

Subject coverage concentrates on the biological, physiological, psychological, and environmental effects to which man is subjected during and following simulated or actual flight in the earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Each entry consists of a standard citation accompanied by its abstract.

Aerospace medicine and biology: A continuing bibliography with indexes (supplement 100)

NASA Technical Reports Server (NTRS)

1972-01-01

Subject coverage concentrates on the biological, physiological, psychological, and environmental effects to which man is subjected during and following simulated or actual flight in the earth's atmosphere or in interplanetary space. Reference describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Each entry consists of a standard citation accompanied by its abstract.

Comparative physicochemical and biological characterization of NIST Interim Reference Material PM2.5 and SRM 1648 in human A549 and mouse RAW264.7 cells.

PubMed

Mitkus, Robert J; Powell, Jan L; Zeisler, Rolf; Squibb, Katherine S

2013-12-01

The epidemiological association between exposure to fine particulate matter (PM2.5) and adverse health effects is well-known. Here we report the size distribution, metals content, endotoxin content, and biological activity of National Institute of Standards and Technology (NIST) Interim Reference Material (RM) PM2.5. Biological activity was measured in vitro by effects on cell viability and the release of four inflammatory immune mediators, from human A549 alveolar epithelial cells or murine RAW264.7 monocytes. A dose range covering three orders of magnitude (1-1000μg/mL) was tested, and biological activity was compared to an existing Standard Reference Material (SRM) for urban PM (NIST SRM 1648). Robust release of IL-8 and MCP-1 from A549 cells was observed in response to IRM PM2.5 exposures. Significant TNF-α, but not IL-6, secretion from RAW264.7 cells was observed in response to both IRM PM2.5 and SRM 1648 particle types. Cytokine or chemokine release at high doses often occurred in the presence of cytotoxicity, likely as a result of externalization of preformed mediator. Our results are consistent with a local cytotoxic and pro-inflammatory mechanism of response to exposure to inhaled ambient PM2.5 and reinforce the continued relevance of in vitro assays for mechanistic research in PM toxicology. Our study furthers the goal of developing reference samples of environmentally relevant particulate matter of various sizes that can be used for hypothesis testing by multiple investigators. Published by Elsevier Ltd.

A cumulative index to a continuing bibliography on aerospace medicine and biology, January 1972

NASA Technical Reports Server (NTRS)

1972-01-01

Subject coverage concentrates on the biological, physiological, psychological, and environmental effects to which man is subjected during and following simulated or actual flight in the earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Each entry consists of a standard citation accompanied by its abstract.

INAA Application for Trace Element Determination in Biological Reference Material

NASA Astrophysics Data System (ADS)

Atmodjo, D. P. D.; Kurniawati, S.; Lestiani, D. D.; Adventini, N.

2017-06-01

Trace element determination in biological samples is often used in the study of health and toxicology. Determination change to its essentiality and toxicity of trace element require an accurate determination method, which implies that a good Quality Control (QC) procedure should be performed. In this study, QC for trace element determination in biological samples was applied by analyzing the Standard Reference Material (SRM) Bovine muscle 8414 NIST using Instrumental Neutron Activation Analysis (INAA). Three selected trace element such as Fe, Zn, and Se were determined. Accuracy of the elements showed as %recovery and precision as %coefficient of variance (%CV). The result showed that %recovery of Fe, Zn, and Se were in the range between 99.4-107%, 92.7-103%, and 91.9-112%, respectively, whereas %CV were 2.92, 3.70, and 5.37%, respectively. These results showed that INAA method is precise and accurate for trace element determination in biological matrices.

U.S. Army Medical Research Institute of Infectious Diseases

MedlinePlus

... Health Organization. As a reference laboratory for the Department of Defense, we set the standard for identification of biological agents. Our customers in the Army and the Department of Defense know us as a "tech base" organization that ...

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 485

NASA Technical Reports Server (NTRS)

1999-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. The NASA CASI price code table, addresses of organizations, and document availability information are included before the abstract section. Two indexes-subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography With Indexes. Supplement 506

NASA Technical Reports Server (NTRS)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP#2000-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. The NASA CASI price code table, addresses of organizations, and document availability information are included before the abstract section. Two indexes- subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 494

NASA Technical Reports Server (NTRS)

1999-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. The NASA CASI price code table, addresses of organizations, and document availability information are included before the abstract section. Two indexes--subject and author are included after the abstract section.

WHO Expert Committee on Biological Standardization.

PubMed

2002-01-01

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and quality control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on issues relevant to international guidelines, recommendations and other matters related to the manufacture and quality control of biologicals. This is followed by information on the status and development of reference materials for bovine spongiform encephalopathy, various antigens, blood products, cytokines, growth factors and endocrinological substances. The second part of the report, of particular interest to manufacturers and national control authorities, contains sets of recommendations for the production and control of poliomyelitis vaccine (oral) and poliomyelitis vaccine (inactivated) and guidelines for the production and control of live attenuated Japanese encephalitis vaccine. Also included are lists of recommendations and guidelines for biological substances used in medicine, and other relevant documents.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 496

NASA Technical Reports Server (NTRS)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP#2000-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth#s atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. The NASA CASI price code table, addresses of organizations, and document availability information are included before the abstract section. Two indexes#subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography With Indexes. Supplement 499

NASA Technical Reports Server (NTRS)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP#1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth#s atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. The NASA CASI price code table, addresses of organizations, and document availability information are included before the abstract section. Two indexes-subject and author are included after the abstract section.

Recommendation for the review of biological reference intervals in medical laboratories.

PubMed

Henny, Joseph; Vassault, Anne; Boursier, Guilaine; Vukasovic, Ines; Mesko Brguljan, Pika; Lohmander, Maria; Ghita, Irina; Andreu, Francisco A Bernabeu; Kroupis, Christos; Sprongl, Ludek; Thelen, Marc H M; Vanstapel, Florent J L A; Vodnik, Tatjana; Huisman, Willem; Vaubourdolle, Michel

2016-12-01

This document is based on the original recommendation of the Expert Panel on the Theory of Reference Values of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), updated guidelines were recently published under the auspices of the IFCC and the Clinical and Laboratory Standards Institute (CLSI). This document summarizes proposals for recommendations on: (i) The terminology, which is often confusing, noticeably concerning the terms of reference limits and decision limits. (ii) The method for the determination of reference limits according to the original procedure and the conditions, which should be used. (iii) A simple procedure allowing the medical laboratories to fulfill the requirements of the regulation and standards. The updated document proposes to verify that published reference limits are applicable to the laboratory involved. Finally, the strengths and limits of the revised recommendations (especially the selection of the reference population, the maintenance of the analytical quality, the choice of the statistical method used…) will be briefly discussed.

Blood lipid measurements. Variations and practical utility.

PubMed

Cooper, G R; Myers, G L; Smith, S J; Schlant, R C

1992-03-25

To describe the magnitude and impact of the major biological and analytical sources of variation in serum lipid and lipoprotein levels on risk of coronary heart disease; to present a way to qualitatively estimate the total intraindividual variation; and to demonstrate how to determine the number of specimens required to estimate, with 95% confidence, the "true" underlying total cholesterol value in the serum of a patient. Representative references on each source of variation were selected from more than 300 reviewed publications, most published within the past 5 years, to document current findings and concepts. Most articles reviewed were in English. Studies on biological sources of variation were selected using the following criteria: representative of published findings, clear statement of either significant or insignificant results, and acquisition of clinical and laboratory data under standardized conditions. Representative results for special populations such as women and children are reported when results differ from those of adult men. References were selected based on acceptable experimental design and use of standardized laboratory lipid measurements. The lipid levels considered representative for a selected source of variation arose from quantitative measurements by a suitably standardized laboratory. Statistical analysis of data was examined to assure reliability. The proposed method of estimating the biological coefficient of variation must be considered to give qualitative results, because only two or three serial specimens are collected in most cases for the estimation. Concern has arisen about the magnitude, impact, and interpretation of preanalytical as well as analytical sources of variation on reported results of lipid measurements of an individual. Preanalytical sources of variation from behavioral, clinical, and sampling sources constitute about 60% of the total variation in a reported lipid measurement of an individual. A technique is presented to allow physicians to qualitatively estimate the intraindividual biological variation of a patient from the results of two or more specimens reported from a standardized laboratory and to determine whether additional specimens are needed to meet the National Cholesterol Education Program recommendation that the intraindividual serum total cholesterol coefficient of variation not exceed 5.0. A National Reference Method Network has been established to help solve analytical problems.

Statistical inference from multiple iTRAQ experiments without using common reference standards.

PubMed

Herbrich, Shelley M; Cole, Robert N; West, Keith P; Schulze, Kerry; Yager, James D; Groopman, John D; Christian, Parul; Wu, Lee; O'Meally, Robert N; May, Damon H; McIntosh, Martin W; Ruczinski, Ingo

2013-02-01

Isobaric tags for relative and absolute quantitation (iTRAQ) is a prominent mass spectrometry technology for protein identification and quantification that is capable of analyzing multiple samples in a single experiment. Frequently, iTRAQ experiments are carried out using an aliquot from a pool of all samples, or "masterpool", in one of the channels as a reference sample standard to estimate protein relative abundances in the biological samples and to combine abundance estimates from multiple experiments. In this manuscript, we show that using a masterpool is counterproductive. We obtain more precise estimates of protein relative abundance by using the available biological data instead of the masterpool and do not need to occupy a channel that could otherwise be used for another biological sample. In addition, we introduce a simple statistical method to associate proteomic data from multiple iTRAQ experiments with a numeric response and show that this approach is more powerful than the conventionally employed masterpool-based approach. We illustrate our methods using data from four replicate iTRAQ experiments on aliquots of the same pool of plasma samples and from a 406-sample project designed to identify plasma proteins that covary with nutrient concentrations in chronically undernourished children from South Asia.

Quantity quotient reporting. A proposal for a standardized presentation of laboratory results.

PubMed

Haeckel, Rainer; Wosniok, Werner

2009-01-01

Laboratory results are reported in different units (despite international recommendations for SI units) together with different reference limits, of which several exist for many quantities. It is proposed to adopt the concept of the intelligence quotient and to report quantitative results as a quantity quotient (QQ) in laboratory medicine. This quotient is essentially the difference (measured result minus mean or mode value of the reference interval) divided by the observed biological variation CV(o). Thus, all quantities are reported in the same unit system with the same reference limits (for convenience shifted to e.g., 80-120). The critical difference can also be included in this standardization concept. In this way the information of reference intervals and the original result are integrated into one combined value, which has the same format for all quantities suited for quotient reporting (QR). The proposal of QR does not interfere with neither the current concepts of traceability, SI units or method standardization. This proposal represents a further step towards harmonization of reporting. It provides simple values which can be interpreted easily by physicians and their patients.

Quantification of drugs in plasma without primary reference standards by liquid chromatography-chemiluminescence nitrogen detection: application to tramadol metabolite ratios.

PubMed

Ojanperä, Suvi; Rasanen, Ilpo; Sistonen, Johanna; Pelander, Anna; Vuori, Erkki; Ojanperä, Ilkka

2007-08-01

Lack of availability of reference standards for drug metabolites, newly released drugs, and illicit drugs hinders the analysis of these substances in biologic samples. To counter this problem, an approach is presented here for quantitative drug analysis in plasma without primary reference standards by liquid chromatography-chemiluminescence nitrogen detection (LC-CLND). To demonstrate the feasibility of the method, metabolic ratios of the opioid drug tramadol were determined in the setting of a pharmacogenetic study. Four volunteers were given a single 100-mg oral dose of tramadol, and a blood sample was collected from each subject 1 hour later. Tramadol, O-desmethyltramadol, and nortramadol were determined in plasma by LC-CLND without reference standards and by a gas chromatography-mass spectrometry reference method. In contrast to previous CLND studies lacking an extraction step, a liquid-liquid extraction system was created for 5-mL plasma samples using n-butyl chloride-isopropyl alcohol (98 + 2) at pH 10. Extraction recovery estimation was based on model compounds chosen according to their similar physicochemical characteristics (retention time, pKa, logD). Instrument calibration was performed with a single secondary standard (caffeine) using the equimolar response of the detector to nitrogen. The mean differences between the results of the LC-CLND and gas chromatography-mass spectrometry methods for tramadol, O-desmethyltramadol, and nortramadol were 8%, 32%, and 19%, respectively. The sensitivity of LC-CLND was sufficient for therapeutic concentrations of tramadol and metabolites. A good correlation was obtained between genotype, expressed by the number of functional genes, and the plasma metabolite ratios. This experiment suggests that a recovery-corrected LC-CLND analysis produces sufficiently accurate results to be useful in a clinical context, particularly in instances in which reference standards are not readily accessible.

Biological reference materials for extracellular vesicle studies.

PubMed

Valkonen, S; van der Pol, E; Böing, A; Yuana, Y; Yliperttula, M; Nieuwland, R; Laitinen, S; Siljander, P R M

2017-02-15

Extracellular vesicles (EVs) mediate normal physiological homeostasis and pathological processes by facilitating intercellular communication. Research of EVs in basic science and clinical settings requires both methodological standardization and development of reference materials (RM). Here, we show insights and results of biological RM development for EV studies. We used a three-step approach to find and develop a biological RM. First, a literature search was done to find candidates for biological RMs. Second, a questionnaire was sent to EV researchers querying the preferences for RM and their use. Third, a biological RM was selected, developed, characterized, and evaluated. The responses to the survey demonstrated a clear and recognized need for RM optimized for the calibration of EV measurements. Based on the literature, naturally occurring and produced biological RM, such as virus particles and liposomes, were proposed as RM. However, none of these candidate RMs have properties completely matching those of EVs, such as size and refractive index distribution. Therefore, we evaluated the use of nanoerythrosomes (NanoE), vesicles produced from erythrocytes, as a potential biological RM. The strength of NanoE is their resemblance to EVs. Compared to the erythrocyte-derived EVs (eryEVs), NanoE have similar morphology, a similar refractive index (1.37), larger diameter (70% of the NanoE are over 200nm), and increased positive staining for CD235a and lipids (Di-8-ANEPPS) (58% and 67% in NanoE vs. 21% and 45% in eryEVs, respectively). Altogether, our results highlight the general need to develop and validate new RM with similar physical and biochemical properties as EVs to standardize EV measurements between instruments and laboratories. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Collaborative study for the calibration of replacement batches for the heparin low-molecular-mass for assay biological reference preparation.

PubMed

Terao, E; Daas, A

2016-01-01

The European Pharmacopoeia (Ph. Eur.) prescribes the control of the activity of low molecular mass heparins by assays for anti-Xa and anti-IIa activities (monograph 0828), using a reference standard calibrated in International Units (IU). An international collaborative study coded BSP133 was launched in the framework of the Biological Standardisation Programme (BSP) run under the aegis of the Council of Europe and the European Commission to calibrate replacement batches for the dwindling stocks of the Heparin low-molecular-mass for assay Biological Reference Preparation (BRP) batch 8. Thirteen official medicines control and manufacturers laboratories from European and non-European countries took part in this study to calibrate two freeze-dried candidate batches against the 3rd International Standard (IS) for heparin, low molecular weight (11/176; 3rd IS). The Heparin low-molecular-mass for assay BRP (batch 8) was also included in the test panel to check the continuity between subsequent BRP batches. Taking into account the stability data, the results of this collaborative study and on the basis of the central statistical analysis performed at the European Directorate for the Quality of Medicines & HealthCare (EDQM), the 2 candidate batches were officially adopted by the Commission of the European Pharmacopoeia as Heparin low-molecular-mass for assay BRP batches 9 and 10 with assigned anti-Xa activities of 102 and 100 IU/vial and anti-IIa activities of 34 and 33 IU/vial respectively.

Arguing for Evolution.

ERIC Educational Resources Information Center

Ayala, Francisco J.

2000-01-01

Discusses the Kansas State Board of Education's decision to remove references to evolution and cosmology from the state's education standards and assessment. Advocates the need to teach evolution in high schools for a meaningful biology education. Addresses the question whether the teaching of evolution poses a threat to Christianity or other…

Biologically Based Restorative Management of Tooth Wear

PubMed Central

Kelleher, Martin G. D.; Bomfim, Deborah I.; Austin, Rupert S.

2012-01-01

The prevalence and severity of tooth wear is increasing in industrialised nations. Yet, there is no high-level evidence to support or refute any therapeutic intervention. In the absence of such evidence, many currently prevailing management strategies for tooth wear may be failing in their duty of care to first and foremost improve the oral health of patients with this disease. This paper promotes biologically sound approaches to the management of tooth wear on the basis of current best evidence of the aetiology and clinical features of this disease. The relative risks and benefits of the varying approaches to managing tooth wear are discussed with reference to long-term follow-up studies. Using reference to ethical standards such as “The Daughter Test”, this paper presents case reports of patients with moderate-to-severe levels of tooth wear managed in line with these biologically sound principles. PMID:22315608

EDRN Standard Operating Procedures (SOP) — EDRN Public Portal

Cancer.gov

The NCI’s Early Detection Research Network is developing a number of standard operating procedures for assays, methods, and protocols for collection and processing of biological samples, and other reference materials to assist investigators to conduct experiments in a consistent, reliable manner. These SOPs are established by the investigators of the Early Detection Research Network to maintain constancy throughout the Network. These SOPs represent neither a consensus, nor are the recommendations of NCI.

Synthesis, molecular modeling and evaluation of α-glucosidase inhibition activity of 3,4-dihydroxy piperidines.

PubMed

Kasturi, Siva Prasad; Surarapu, Sujatha; Uppalanchi, Srinivas; Dwivedi, Shubham; Yogeeswari, Perumal; Sigalapalli, Dilep Kumar; Bathini, Nagendra Babu; Ethiraj, Krishna S; Anireddy, Jaya Shree

2018-04-25

Biological evaluation of 3,4-dihydroxy piperidines as α-glucosidase inhibitors is being reported for the first time. Forty-five derivatives (amides, di-amides and sulfonamides) were made using cis and trans 3,4-dihydroxy piperidines to evaluate their α-glucosidase inhibition activity. Polar groups (-OH, -NH 2 ) on phenyl ring having derivatives 5i, 5l, 7g, 7i &12j showed excellent activity compared to standard references. Acarbose, Voglibose and Miglitol were used as standard references. Molecular docking simulations were done for compounds to identify important binding modes responsible for inhibition activity of α-glucosidase. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

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.

Application of quantitative 1H NMR for the calibration of protoberberine alkaloid reference standards.

PubMed

Wu, Yan; He, Yi; He, Wenyi; Zhang, Yumei; Lu, Jing; Dai, Zhong; Ma, Shuangcheng; Lin, Ruichao

2014-03-01

Quantitative nuclear magnetic resonance spectroscopy (qNMR) has been developed into an important tool in the drug analysis, biomacromolecule detection, and metabolism study. Compared with mass balance method, qNMR method bears some advantages in the calibration of reference standard (RS): it determines the absolute amount of a sample; other chemical compound and its certified reference material (CRM) can be used as internal standard (IS) to obtain the purity of the sample. Protoberberine alkaloids have many biological activities and have been used as reference standards for the control of many herbal drugs. In present study, the qNMR methods were developed for the calibration of berberine hydrochloride, palmatine hydrochloride, tetrahydropalmatine, and phellodendrine hydrochloride with potassium hydrogen phthalate as IS. Method validation was carried out according to the guidelines for the method validation of Chinese Pharmacopoeia. The results of qNMR were compared with those of mass balance method and the differences between the results of two methods were acceptable based on the analysis of estimated measurement uncertainties. Therefore, qNMR is an effective and reliable analysis method for the calibration of RS and can be used as a good complementarity to the mass balance method. Copyright © 2013 Elsevier B.V. All rights reserved.

Selection of reference genes for RT-qPCR analysis in a predatory biological control agent, Coleomegilla maculata (Coleoptera: Coccinellidae).

PubMed

Yang, Chunxiao; Pan, Huipeng; Noland, Jeffrey Edward; Zhang, Deyong; Zhang, Zhanhong; Liu, Yong; Zhou, Xuguo

2015-12-10

Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) is a reliable technique for quantifying gene expression across various biological processes, of which requires a set of suited reference genes to normalize the expression data. Coleomegilla maculata (Coleoptera: Coccinellidae), is one of the most extensively used biological control agents in the field to manage arthropod pest species. In this study, expression profiles of 16 housekeeping genes selected from C. maculata were cloned and investigated. The performance of these candidates as endogenous controls under specific experimental conditions was evaluated by dedicated algorithms, including geNorm, Normfinder, BestKeeper, and ΔCt method. In addition, RefFinder, a comprehensive platform integrating all the above-mentioned algorithms, ranked the overall stability of these candidate genes. As a result, various sets of suitable reference genes were recommended specifically for experiments involving different tissues, developmental stages, sex, and C. maculate larvae treated with dietary double stranded RNA. This study represents the critical first step to establish a standardized RT-qPCR protocol for the functional genomics research in a ladybeetle C. maculate. Furthermore, it lays the foundation for conducting ecological risk assessment of RNAi-based gene silencing biotechnologies on non-target organisms; in this case, a key predatory biological control agent.

Tadpoles: the Biology of Anuran Larvae

USGS Publications Warehouse

McDiarmid, R.W.; Altig, R.

1999-01-01

The recent alarming declines in amphibian populations worldwide and the suitability of amphibians for use in answering research questions in disciplines as diverse as molecular systematics, animal behavior, ecology, and evolutionary biology have focused enormous attention on tadpoles. Yet despite this growing interest, relatively little is known about these fascinating creatures. n this invaluable reference, leading experts on tadpole biology relate what we currently know about tadpoles and what we might learn from them in the future. Tadpoles provides detailed summaries of tadpole morphology, development, behavior, ecology, and environmental physiology; explores the evolutionary consequences of the tadpole stage; synthesizes available information on their biodiversity, and presents a standardized terminology and an exhaustive literature review of tadpole biology.

FDA's Approach to Regulating Biosimilars.

PubMed

Lemery, Steven J; Ricci, M Stacey; Keegan, Patricia; McKee, Amy E; Pazdur, Richard

2017-04-15

The Biologics Price Competition and Innovation (BPCI) Act, enacted as part of the Affordable Care Act, created a new licensure pathway for biological products demonstrated to be biosimilar with or interchangeable with an FDA-licensed biological product (the "reference product"). The FDA's approach to the regulation of biosimilars is based on the requirements set forth in the BPCI Act. A biosimilar product is highly similar to the reference product, notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between products in terms of safety, purity, and potency. The foundation of a biosimilar development program is an analytic similarity assessment that directly compares the structural/physiochemical and functional properties of the proposed biosimilar with the reference product. Data from clinical studies, which include an assessment of immunogenicity and pharmacokinetics/pharmacodynamics, are used to assess for clinically meaningful differences and not to independently establish the safety and effectiveness of the biosimilar. Like all products that the FDA regulates, the FDA requires that biosimilar products meet the agency's rigorous standards of safety and efficacy for approval. That means patients and health care professionals are able to rely upon the safety and effectiveness of biosimilar products in the same manner as for the reference product. Clin Cancer Res; 23(8); 1882-5. ©2016 AACR . ©2016 American Association for Cancer Research.

Fish gelatin thin film standards for biological application of PIXE

NASA Astrophysics Data System (ADS)

Manuel, Jack E.; Rout, Bibhudutta; Szilasi, Szabolcs Z.; Bohara, Gyanendra; Deaton, James; Luyombya, Henry; Briski, Karen P.; Glass, Gary A.

2014-08-01

There exists a critical need to understand the flow and accumulation of metallic ions, both naturally occurring and those introduced to biological systems. In this paper the results of fabricating thin film elemental biological standards containing nearly any combination of trace elements in a protein matrix are presented. Because it is capable of high elemental sensitivity, particle induced X-ray emission spectrometry (PIXE) is an excellent candidate for in situ analysis of biological tissues. Additionally, the utilization of microbeam PIXE allows the determination of elemental concentrations in and around biological cells. However, obtaining elemental reference standards with the same matrix constituents as brain tissue is difficult. An excellent choice for simulating brain-like tissue is Norland® photoengraving glue which is derived from fish skin. Fish glue is water soluble, liquid at room temperature, and resistant to dilute acid. It can also be formed into a thin membrane which dries into a durable, self-supporting film. Elements of interest are introduced to the fish glue in precise volumetric additions of well quantified atomic absorption standard solutions. In this study GeoPIXE analysis package is used to quantify elements intrinsic to the fish glue as well as trace amounts of manganese added to the sample. Elastic (non-Rutherford) backscattered spectroscopy (EBS) and the 1.734 MeV proton-on-carbon 12C(p,p)12C resonance is used for a normalization scheme of the PIXE spectra to account for any discrepancies in X-ray production arising from thickness variation of the prepared standards. It is demonstrated that greater additions of the atomic absorption standard cause a viscosity reduction of the liquid fish glue resulting in thinner films but the film thickness can be monitored by using simultaneous PIXE and EBS proton data acquisition.

USGS48 Puerto Rico precipitation - A new isotopic reference material for δ2H and δ18O measurements of water

USGS Publications Warehouse

Qi, Haiping; Coplen, Tyler B.; Tarbox, Lauren V.; Lorenz, Jennifer M.; Scholl, Martha A.

2014-01-01

A new secondary isotopic reference material has been prepared from Puerto Rico precipitation, which was filtered, homogenised, loaded into glass ampoules, sealed with a torch, autoclaved to eliminate biological activity, and calibrated by dual-inlet isotope-ratio mass spectrometry. This isotopic reference material, designated as USGS48, is intended to be one of two isotopic reference waters for daily normalisation of stable hydrogen (δ2H) and stable oxygen (δ18O) isotopic analysis of water with a mass spectrometer or a laser absorption spectrometer. The δ2H and δ18O values of this reference water are−2.0±0.4 and−2.224±0.012 ‰, respectively, relative to Vienna Standard Mean Ocean Water on scales normalised such that the δ2H and δ18O values of Standard Light Antarctic Precipitation reference water are−428 and−55.5 ‰, respectively. Each uncertainty is an estimated expanded uncertainty (U=2uc) about the reference value that provides an interval that has about a 95 % probability of encompassing the true value. This isotopic reference water is available by the case of 144 glass ampoules containing 5 mL of water in each ampoule.

Decision-Making Competence in Biology Education: Implementation into German Curricula in Relation to International Approaches

ERIC Educational Resources Information Center

Steffen, Benjamin; Hößle, Corinna

2014-01-01

The integration of decision-making competence or comparable constructs into science education has been strongly enforced during the last twenty years. Germany captured the tendency with the introduction of national standards for science education that included a domain that refers to decision-making competence. This domain--"evaluation and…

Accurate quantitation standards of glutathione via traceable sulfur measurement by inductively coupled plasma optical emission spectrometry and ion chromatography

PubMed Central

Rastogi, L.; Dash, K.; Arunachalam, J.

2013-01-01

The quantitative analysis of glutathione (GSH) is important in different fields like medicine, biology, and biotechnology. Accurate quantitative measurements of this analyte have been hampered by the lack of well characterized reference standards. The proposed procedure is intended to provide an accurate and definitive method for the quantitation of GSH for reference measurements. Measurement of the stoichiometrically existing sulfur content in purified GSH offers an approach for its quantitation and calibration through an appropriate characterized reference material (CRM) for sulfur would provide a methodology for the certification of GSH quantity, that is traceable to SI (International system of units). The inductively coupled plasma optical emission spectrometry (ICP-OES) approach negates the need for any sample digestion. The sulfur content of the purified GSH is quantitatively converted into sulfate ions by microwave-assisted UV digestion in the presence of hydrogen peroxide prior to ion chromatography (IC) measurements. The measurement of sulfur by ICP-OES and IC (as sulfate) using the “high performance” methodology could be useful for characterizing primary calibration standards and certified reference materials with low uncertainties. The relative expanded uncertainties (% U) expressed at 95% confidence interval for ICP-OES analyses varied from 0.1% to 0.3%, while in the case of IC, they were between 0.2% and 1.2%. The described methods are more suitable for characterizing primary calibration standards and certifying reference materials of GSH, than for routine measurements. PMID:29403814

Biological aerosol background characterization

NASA Astrophysics Data System (ADS)

Blatny, Janet; Fountain, Augustus W., III

2011-05-01

To provide useful information during military operations, or as part of other security situations, a biological aerosol detector has to respond within seconds or minutes to an attack by virulent biological agents, and with low false alarms. Within this time frame, measuring virulence of a known microorganism is extremely difficult, especially if the microorganism is of unknown antigenic or nucleic acid properties. Measuring "live" characteristics of an organism directly is not generally an option, yet only viable organisms are potentially infectious. Fluorescence based instruments have been designed to optically determine if aerosol particles have viability characteristics. Still, such commercially available biological aerosol detection equipment needs to be improved for their use in military and civil applications. Air has an endogenous population of microorganisms that may interfere with alarm software technologies. To design robust algorithms, a comprehensive knowledge of the airborne biological background content is essential. For this reason, there is a need to study ambient live bacterial populations in as many locations as possible. Doing so will permit collection of data to define diverse biological characteristics that in turn can be used to fine tune alarm algorithms. To avoid false alarms, improving software technologies for biological detectors is a crucial feature requiring considerations of various parameters that can be applied to suppress alarm triggers. This NATO Task Group will aim for developing reference methods for monitoring biological aerosol characteristics to improve alarm algorithms for biological detection. Additionally, they will focus on developing reference standard methodology for monitoring biological aerosol characteristics to reduce false alarm rates.

The Third International Reference Preparation of Egg Lecithin

PubMed Central

Krag, P.; Bentzon, M. Weis

1961-01-01

The Third International Reference Preparation of Egg Lecithin was produced (in a quantity of 5000 ml) at the WHO Serological Reference Centre, Copenhagen, and assayed in 1958 against the Second International Reference Preparation by four laboratories in three countries. Complement-fixation and slide-flocculation tests were used. The new preparation was found acceptable, and its establishment was authorized by the WHO Expert Committee on Biological Standardization. The average log10 titres and results of analyses of variances are shown. The variances were of the usual order of magnitude, and the differences in titre between antigens containing the Second and the Third International Reference Preparations varied from -0.011 to 0.116; only one of the differences exceeded the 5% limit of significance. The use of the Third International Reference Preparation in tests for the acceptability of lecithin preparations is described. PMID:13753864

History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology.

PubMed

Kalantar-Zadeh, Kamyar

2017-01-01

Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered biologic proteins derived from human, animal, or microorganism sources are a major area of growth in modern medical care, accounting for one-third of new drug approvals in the past decade. Despite benefit to patients, the use of biologics comes at a significant cost, representing one of the fastest growing segments of strained healthcare budgets around the world. Biosimilars, or biologic drugs that are designed to be highly similar to approved reference biologic drugs, have been available in Europe for more than 10 years with no unusual or unexpected effects compared to their reference biologics whose patents have expired. Given the success of the biosimilar approval pathway pioneered in Europe, it has served as a global reference for other regulatory authorities to establish and implement biosimilar licensure frameworks, including the United States (US), the largest pharmaceutical market in the world. Given 10 of the top 25 drugs sold in 2014 were biologics, and considering the rising costs of healthcare, biosimilars have the potential to become a significant part of the US market. Key Messages: For the nephrology community, the recent patent expiries for epoetin alfa (Epogen®, Amgen and Procrit®, Johnson & Johnson) have created the opportunity to develop biosimilar EPOs. And while no biosimilar in this therapeutic class is approved in the US, there are proposed biosimilars in development. © 2017 S. Karger AG, Basel.

Analytical performance specifications for changes in assay bias (Δbias) for data with logarithmic distributions as assessed by effects on reference change values.

PubMed

Petersen, Per H; Lund, Flemming; Fraser, Callum G; Sölétormos, György

2016-11-01

Background The distributions of within-subject biological variation are usually described as coefficients of variation, as are analytical performance specifications for bias, imprecision and other characteristics. Estimation of specifications required for reference change values is traditionally done using relationship between the batch-related changes during routine performance, described as Δbias, and the coefficients of variation for analytical imprecision (CV A ): the original theory is based on standard deviations or coefficients of variation calculated as if distributions were Gaussian. Methods The distribution of between-subject biological variation can generally be described as log-Gaussian. Moreover, recent analyses of within-subject biological variation suggest that many measurands have log-Gaussian distributions. In consequence, we generated a model for the estimation of analytical performance specifications for reference change value, with combination of Δbias and CV A based on log-Gaussian distributions of CV I as natural logarithms. The model was tested using plasma prolactin and glucose as examples. Results Analytical performance specifications for reference change value generated using the new model based on log-Gaussian distributions were practically identical with the traditional model based on Gaussian distributions. Conclusion The traditional and simple to apply model used to generate analytical performance specifications for reference change value, based on the use of coefficients of variation and assuming Gaussian distributions for both CV I and CV A , is generally useful.

Establishment of a biological reference preparation for hepatitis A vaccine (inactivated, non-adsorbed).

PubMed

Stalder, J; Costanzo, A; Daas, A; Rautmann, G; Buchheit, K-H

2010-04-01

A reference standard calibrated in International Units (IU) is needed for the in vitro potency assay of hepatitis A vaccines prepared by formalin-inactivation of purified hepatitis A virus grown in cell cultures. Thus, a project was launched by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish one or more non-adsorbed inactivated hepatitis A vaccine reference preparation(s) as working standard(s), calibrated against the 1st International Standard (IS), for the in vitro potency assay (ELISA) of all vaccines present on the European market. Four non-adsorbed liquid preparations of formalin-inactivated hepatitis A antigen with a known antigen content were obtained from 3 manufacturers as candidate Biological Reference Preparations (BRPs). Thirteen laboratories participated in the collaborative study. They were asked to use an in vitro ELISA method adapted from a commercially available kit for the detection of antibodies to hepatitis A virus. In-house validated assays were to be run in parallel, where available. Some participants also included commercially available hepatitis A vaccines in the assays, after appropriate desorption. During the collaborative study, several participants using the standard method were faced with problems with some of the most recent lots of the test kits. Due to these problems, the standard method did not perform satisfactorily and a high number of assays were invalid, whereas the in-house methods appeared to perform better. Despite this, the overall mean results of the valid assays using both methods were in agreement. Nonetheless, it was decided to base the assignment of the potency values on the in-house methods only. The results showed that all candidate BRPs were suitable for the intended purpose. However, based on availability of the material and on the results of end-product testing, 2 candidate reference preparations, Samples C and D, were selected. Both were from the same batch but filled on different days; no statistically significant difference in potency was observed. They were thus combined in 1 single batch. The candidate preparation (Sample C/D) was adopted at the June 2009 session of the European Pharmacopoeia (Ph. Eur.) Commission as the Ph. Eur. BRP batch 1 for hepatitis A vaccine (inactivated, non-adsorbed), with an assigned potency of 12 IU/ml for in vitro antigen content assays. Accelerated degradation studies have been initiated. The preliminary data show that the BRP is stable at the recommended storage temperature (< -50 degrees C). The BRP will be monitored at regular intervals throughout its lifetime.

Protein quantification using a cleavable reporter peptide.

PubMed

Duriez, Elodie; Trevisiol, Stephane; Domon, Bruno

2015-02-06

Peptide and protein quantification based on isotope dilution and mass spectrometry analysis are widely employed for the measurement of biomarkers and in system biology applications. The accuracy and reliability of such quantitative assays depend on the quality of the stable-isotope labeled standards. Although the quantification using stable-isotope labeled peptides is precise, the accuracy of the results can be severely biased by the purity of the internal standards, their stability and formulation, and the determination of their concentration. Here we describe a rapid and cost-efficient method to recalibrate stable isotope labeled peptides in a single LC-MS analysis. The method is based on the equimolar release of a protein reference peptide (used as surrogate for the protein of interest) and a universal reporter peptide during the trypsinization of a concatenated polypeptide standard. The quality and accuracy of data generated with such concatenated polypeptide standards are highlighted by the quantification of two clinically important proteins in urine samples and compared with results obtained with conventional stable isotope labeled reference peptides. Furthermore, the application of the UCRP standards in complex samples is described.

Automated GC-MS analysis of free amino acids in biological fluids.

PubMed

Kaspar, Hannelore; Dettmer, Katja; Gronwald, Wolfram; Oefner, Peter J

2008-07-15

A gas chromatography-mass spectrometry (GC-MS) method was developed for the quantitative analysis of free amino acids as their propyl chloroformate derivatives in biological fluids. Derivatization with propyl chloroformate is carried out directly in the biological samples without prior protein precipitation or solid-phase extraction of the amino acids, thereby allowing automation of the entire procedure, including addition of reagents, extraction and injection into the GC-MS. The total analysis time was 30 min and 30 amino acids could be reliably quantified using 19 stable isotope-labeled amino acids as internal standards. Limits of detection (LOD) and lower limits of quantification (LLOQ) were in the range of 0.03-12 microM and 0.3-30 microM, respectively. The method was validated using a certified amino acid standard and reference plasma, and its applicability to different biological fluids was shown. Intra-day precision for the analysis of human urine, blood plasma, and cell culture medium was 2.0-8.8%, 0.9-8.3%, and 2.0-14.3%, respectively, while the inter-day precision for human urine was 1.5-14.1%.

[Evaluation of the total biological activity and allergenic composition of allergenic extracts].

PubMed

Lombardero, M; González, R; Duffort, O; Juan, F; Ayuso, R; Ventas, P; Cortés, C; Carreira, J

1986-01-01

In the present study, a complete procedure is presented in order to standardize allergenic extracts, the meaning of which is the measurement of the total allergenic activity and the determination of the allergenic composition. The measurement of the biological activity comprises 2 steps: Preparation of Reference Extracts and determination of their "in vivo" activity. Evaluation of the total allergenic activity of extracts for clinical use. Reference extracts were prepared from the main allergens and their "in vivo" biological activity was determined by a quantitative skin prick test in a sample of at least 30 allergic patients. By definition, the protein concentration of Reference Extract that produces, in the allergic population, a geometric mean wheal of 75 mm.2 has an activity of 100 biological units (BUs). The determination of the biological activity of a problem extract is made by RAST inhibition. The sample is compared with the corresponding Reference Extract by this technique and, from this comparison, it is possible to quantify the activity of the problem extract in biologic units (BUs) with clinical significance. Likewise, different techniques have been used to determine the allergenic composition of extracts. These techniques comprise 2 steps: Separation of the components of the extract. Identification of the components that bind specific human IgE. The separation of the components of the extract has been carried out by isoelectric focusing (IEF) and electrophoresis in the presence of sodium dodecyl sulphate (SDS-PAGE). In order to identify the allergenic components, an immunoblotting technique has been employed. The separated components in the IEF gel or SDS-PAGE gel are transferred to a nitrocellulose sheet and later on, this membrane is overlaid with a serum pool from allergic patients and a mouse monoclonal anti-human IgE, labelled with 125I. Finally, the autoradiography of the nitrocellulose membrane is obtained. In this way it is possible to compare the allergenic composition of an extract with the corresponding Reference Extract and so to employ for clinical use only those extracts with the right allergenic composition.

Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; preparation procedure for aquatic biological material determined for trace metals

USGS Publications Warehouse

Hoffman, Gerald L.

1996-01-01

A method for the chemical preparation of tissue samples that are subsequently analyzed for 22 trace metals is described. The tissue-preparation procedure was tested with three National Institute of Standards and Technology biological standard reference materials and two National Water Quality Laboratory homogenized biological materials. A low-temperature (85 degrees Celsius) nitric acid digestion followed by the careful addition of hydrogen peroxide (30-percent solution) is used to decompose the biological material. The solutions are evaporated to incipient dryness, reconstituted with 5 percent nitric acid, and filtered. After filtration the solutions were diluted to a known volume and analyzed by inductively coupled plasma-mass spectrometry (ICP-MS), inductively coupled plasma-atomic emission spectrometry (ICP-AES), and cold vapor-atomic absorption spectrophotometry (CV-AAS). Many of the metals were determined by both ICP-MS and ICP-AES. This report does not provide a detailed description of the instrumental procedures and conditions used with the three types of instrumentation for the quantitation of trace metals determined in this study. Statistical data regarding recovery, accuracy, and precision for individual trace metals determined in the biological material tested are summarized.

Clinical and preclinical validation of the serum free light chain assay: identification of the critical difference for optimized clinical use.

PubMed

Hansen, Charlotte T; Münster, Anna-Marie; Nielsen, Lars; Pedersen, Per; Abildgaard, Niels

2012-12-01

The use of the assay for the measurements of free light chains in serum (sFLCs) is increasing. However, there are technical limitations that potentially affect the use in serial measurements. We need further knowledge on the standards of analytical precision, the utility of conventional population-based reference values and the critical difference (CD) between serial results required for significance. To answer these questions, the biological variation must be known. We determined the biological variation in healthy individuals and patients with plasma cell dyscrasia (PCD). We assessed the imprecision of the analysis in use from FreeLite™. We determined the reference interval (RI) in 170 healthy individuals. The biological variation is identical for healthy individuals and patients with PCD. The imprecision of the sFLC analysis cannot fulfil the desirable performance standards for a laboratory test, but are within the manufacturer's ±20% variation for quality control samples. RI showed a significant increase for κ FLC and κ/λ ratio with age, but not for λ. Critical difference was calculated to be 24% and 23% for κ and λ, respectively. We suggest the use of an age-dependent RI. When monitoring patients with PCD, their own former results are the best reference, and knowledge on CD is a valuable tool, which we describe for the first time. Also, it challenges the recently proposed International Myeloma Working Group 'paraprotein relapse criteria', recommending an increase of more than 25% in the involved FLC to indicate the need for initiation of retreatment. We recommend revision of this criterion. © 2012 John Wiley & Sons A/S.

MicroRNA Expression in Formalin-fixed Paraffin-embedded Cancer Tissue: Identifying Reference MicroRNAs and Variability.

PubMed

Boisen, Mogens Karsbøl; Dehlendorff, Christian; Linnemann, Dorte; Schultz, Nicolai Aagaard; Jensen, Benny Vittrup; Høgdall, Estrid Vilma Solyom; Johansen, Julia Sidenius

2015-12-29

Archival formalin-fixed paraffin-embedded (FFPE) cancer tissue samples are a readily available resource for microRNA (miRNA) biomarker identification. No established standard for reference miRNAs in FFPE tissue exists. We sought to identify stable reference miRNAs for normalization of miRNA expression in FFPE tissue samples from patients with colorectal (CRC) and pancreatic (PC) cancer and to quantify the variability associated with sample age and fixation. High-throughput miRNA profiling results from 203 CRC and 256 PC FFPE samples as well as from 37 paired frozen/FFPE samples from nine other CRC tumors (methodological samples) were used. Candidate reference miRNAs were identified by their correlation with global mean expression. The stability of reference genes was analyzed according to published methods. The association between sample age and global mean miRNA expression was tested using linear regression. Variability was described using correlation coefficients and linear mixed effects models. Normalization effects were determined by changes in standard deviation and by hierarchical clustering. We created lists of 20 miRNAs with the best correlation to global mean expression in each cancer type. Nine of these miRNAs were present in both lists, and miR-103a-3p was the most stable reference miRNA for both CRC and PC FFPE tissue. The optimal number of reference miRNAs was 4 in CRC and 10 in PC. Sample age had a significant effect on global miRNA expression in PC (50% reduction over 20 years) but not in CRC. Formalin fixation for 2-6 days decreased miRNA expression 30-65%. Normalization using global mean expression reduced variability for technical and biological replicates while normalization using the expression of the identified reference miRNAs reduced variability only for biological replicates. Normalization only had a minor impact on clustering results. We identified suitable reference miRNAs for future miRNA expression experiments using CRC- and PC FFPE tissue samples. Formalin fixation decreased miRNA expression considerably, while the effect of increasing sample age was estimated to be negligible in a clinical setting.

External quality assurance programs as a tool for verifying standardization of measurement procedures: Pilot collaboration in Europe.

PubMed

Perich, C; Ricós, C; Alvarez, V; Biosca, C; Boned, B; Cava, F; Doménech, M V; Fernández-Calle, P; Fernández-Fernández, P; García-Lario, J V; Minchinela, J; Simón, M; Jansen, R

2014-05-15

Current external quality assurance schemes have been classified into six categories, according to their ability to verify the degree of standardization of the participating measurement procedures. SKML (Netherlands) is a Category 1 EQA scheme (commutable EQA materials with values assigned by reference methods), whereas SEQC (Spain) is a Category 5 scheme (replicate analyses of non-commutable materials with no values assigned by reference methods). The results obtained by a group of Spanish laboratories participating in a pilot study organized by SKML are examined, with the aim of pointing out the improvements over our current scheme that a Category 1 program could provide. Imprecision and bias are calculated for each analyte and laboratory, and compared with quality specifications derived from biological variation. Of the 26 analytes studied, 9 had results comparable with those from reference methods, and 10 analytes did not have comparable results. The remaining 7 analytes measured did not have available reference method values, and in these cases, comparison with the peer group showed comparable results. The reasons for disagreement in the second group can be summarized as: use of non-standard methods (IFCC without exogenous pyridoxal phosphate for AST and ALT, Jaffé kinetic at low-normal creatinine concentrations and with eGFR); non-commutability of the reference material used to assign values to the routine calibrator (calcium, magnesium and sodium); use of reference materials without established commutability instead of reference methods for AST and GGT, and lack of a systematic effort by manufacturers to harmonize results. Results obtained in this work demonstrate the important role of external quality assurance programs using commutable materials with values assigned by reference methods to correctly monitor the standardization of laboratory tests with consequent minimization of risk to patients. Copyright © 2013 Elsevier B.V. All rights reserved.

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

Evaluation of Candidate Reference Genes for Quantitative Gene Expression Analysis in Spodoptera exigu a after Long-time Exposure to Cadmium.

PubMed

Płachetka-Bożek, Anna; Augustyniak, Maria

2017-08-21

Studies on the transcriptional control of gene expression play an important role in many areas of biology. Reference genes, which are often referred to as housekeeping genes, such as GAPDH, G3PDH, EF2, RpL7A, RpL10, TUBα and Actin, have traditionally been assumed to be stably expressed in all conditions, and they are frequently used to normalize mRNA levels between different samples in qPCR analysis. However, it is known that the expression of these genes is influenced by numerous factors, such as experimental conditions. The difference in gene expression underlies a range of biological processes, including development, reproduction and behavior. The aim of this study was to show the problems associated with using reference genes in the qPCR technique, in a study on inbred strains of Spodoptera exigua selected toward cadmium resistance. We present and discuss our results and observations, and give some recommendations concerning the use and limitations of housekeeping genes as internal standards, especially in research on insects. Our results suggest that holometabolism and poikilothermia, as well as time since metamorphosis and the level of exposure to the selective factor (cadmium in this case), have a significant effect on the expression of reference genes.

Characterization of Sulfur Compounds in Coffee Beans by Sulfur K-XANES Spectroscopy

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

Lichtenberg, H.; Hormes, J.; Institute of Physics, University of Bonn, Nussallee 12, 53115 Bonn

2007-02-02

In this 'feasibility study' the influence of roasting on the sulfur speciation in Mexican coffee beans was investigated by sulfur K-XANES Spectroscopy. Spectra of green and slightly roasted beans could be fitted to a linear combination of 'standard' reference spectra for biological samples, whereas longer roasting obviously involves formation of additional sulfur compounds in considerable amounts.

QconCATs: design and expression of concatenated protein standards for multiplexed protein quantification.

PubMed

Simpson, Deborah M; Beynon, Robert J

2012-09-01

Systems biology requires knowledge of the absolute amounts of proteins in order to model biological processes and simulate the effects of changes in specific model parameters. Quantification concatamers (QconCATs) are established as a method to provide multiplexed absolute peptide standards for a set of target proteins in isotope dilution standard experiments. Two or more quantotypic peptides representing each of the target proteins are concatenated into a designer gene that is metabolically labelled with stable isotopes in Escherichia coli or other cellular or cell-free systems. Co-digestion of a known amount of QconCAT with the target proteins generates a set of labelled reference peptide standards for the unlabelled analyte counterparts, and by using an appropriate mass spectrometry platform, comparison of the intensities of the peptide ratios delivers absolute quantification of the encoded peptides and in turn the target proteins for which they are surrogates. In this review, we discuss the criteria and difficulties associated with surrogate peptide selection and provide examples in the design of QconCATs for quantification of the proteins of the nuclear factor κB pathway.

The Biological Macromolecule Crystallization Database and NASA Protein Crystal Growth Archive

PubMed Central

Gilliland, Gary L.; Tung, Michael; Ladner, Jane

1996-01-01

The NIST/NASA/CARB Biological Macromolecule Crystallization Database (BMCD), NIST Standard Reference Database 21, contains crystal data and crystallization conditions for biological macromolecules. The database entries include data abstracted from published crystallographic reports. Each entry consists of information describing the biological macromolecule crystallized and crystal data and the crystallization conditions for each crystal form. The BMCD serves as the NASA Protein Crystal Growth Archive in that it contains protocols and results of crystallization experiments undertaken in microgravity (space). These database entries report the results, whether successful or not, from NASA-sponsored protein crystal growth experiments in microgravity and from microgravity crystallization studies sponsored by other international organizations. The BMCD was designed as a tool to assist x-ray crystallographers in the development of protocols to crystallize biological macromolecules, those that have previously been crystallized, and those that have not been crystallized. PMID:11542472

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.

Human Augmentics: augmenting human evolution.

PubMed

Kenyon, Robert V; Leigh, Jason

2011-01-01

Human Augmentics (HA) refers to technologies for expanding the capabilities, and characteristics of humans. One can think of Human Augmentics as the driving force in the non-biological evolution of humans. HA devices will provide technology to compensate for human biological limitations either natural or acquired. The strengths of HA lie in its applicability to all humans. Its interoperability enables the formation of ecosystems whereby augmented humans can draw from other realms such as "the Cloud" and other augmented humans for strength. The exponential growth in new technologies portends such a system but must be designed for interaction through the use of open-standards and open-APIs for system development. We discuss the conditions needed for HA to flourish with an emphasis on devices that provide non-biological rehabilitation.

The establishment of a WHO Reference Reagent for anti-malaria (Plasmodium falciparum) human serum.

PubMed

Bryan, Donna; Silva, Nilupa; Rigsby, Peter; Dougall, Thomas; Corran, Patrick; Bowyer, Paul W; Ho, Mei Mei

2017-08-05

At a World Health Organization (WHO) sponsored meeting it was concluded that there is an urgent need for a reference preparation that contains antibodies against malaria antigens in order to support serology studies and vaccine development. It was proposed that this reference would take the form of a lyophilized serum or plasma pool from a malaria-endemic area. In response, an immunoassay standard, comprising defibrinated human plasma has been prepared and evaluated in a collaborative study. A pool of human plasma from a malaria endemic region was collected from 140 single plasma donations selected for reactivity to Plasmodium falciparum apical membrane antigen-1 (AMA-1) and merozoite surface proteins (MSP-1 19 , MSP-1 42 , MSP-2 and MSP-3). This pool was defibrinated, filled and freeze dried into a single batch of ampoules to yield a stable source of naturally occurring antibodies to P. falciparum. The preparation was evaluated by an enzyme-linked immunosorbent assay (ELISA) in a collaborative study with sixteen participants from twelve different countries. This anti-malaria human serum preparation (NIBSC Code: 10/198) was adopted by the WHO Expert Committee on Biological Standardization (ECBS) in October 2014, as the first WHO reference reagent for anti-malaria (Plasmodium falciparum) human serum with an assigned arbitrary unitage of 100 units (U) per ampoule. Analysis of the reference reagent in a collaborative study has demonstrated the benefit of this preparation for the reduction in inter- and intra-laboratory variability in ELISA. Whilst locally sourced pools are regularly use for harmonization both within and between a few laboratories, the presence of a WHO-endorsed reference reagent should enable optimal harmonization of malaria serological assays either by direct use of the reference reagent or calibration of local standards against this WHO reference. The intended uses of this reference reagent, a multivalent preparation, are (1) to allow cross-comparisons of results of vaccine trials performed in different centres/with different products; (2) to facilitate standardization and harmonization of immunological assays used in epidemiology research; and (3) to allow optimization and validation of immunological assays used in malaria vaccine development.

Automatic extraction of angiogenesis bioprocess from text

PubMed Central

Wang, Xinglong; McKendrick, Iain; Barrett, Ian; Dix, Ian; French, Tim; Tsujii, Jun'ichi; Ananiadou, Sophia

2011-01-01

Motivation: Understanding key biological processes (bioprocesses) and their relationships with constituent biological entities and pharmaceutical agents is crucial for drug design and discovery. One way to harvest such information is searching the literature. However, bioprocesses are difficult to capture because they may occur in text in a variety of textual expressions. Moreover, a bioprocess is often composed of a series of bioevents, where a bioevent denotes changes to one or a group of cells involved in the bioprocess. Such bioevents are often used to refer to bioprocesses in text, which current techniques, relying solely on specialized lexicons, struggle to find. Results: This article presents a range of methods for finding bioprocess terms and events. To facilitate the study, we built a gold standard corpus in which terms and events related to angiogenesis, a key biological process of the growth of new blood vessels, were annotated. Statistics of the annotated corpus revealed that over 36% of the text expressions that referred to angiogenesis appeared as events. The proposed methods respectively employed domain-specific vocabularies, a manually annotated corpus and unstructured domain-specific documents. Evaluation results showed that, while a supervised machine-learning model yielded the best precision, recall and F1 scores, the other methods achieved reasonable performance and less cost to develop. Availability: The angiogenesis vocabularies, gold standard corpus, annotation guidelines and software described in this article are available at http://text0.mib.man.ac.uk/~mbassxw2/angiogenesis/ Contact: xinglong.wang@gmail.com PMID:21821664

Assessing the impact of adjusting for maturity in weight status classification in a cross-sectional sample of UK children.

PubMed

Gillison, Fiona; Cumming, Sean; Standage, Martyn; Barnaby, Catherine; Katzmarzyk, Peter

2017-06-26

To compare the weight categorisation of a cohort of UK children using standard procedures (ie, comparing body mass index (BMI) centiles to age-matched UK reference data) versus an approach adjusted for maturation status (ie, matching relative to biological age). Analysis of data collected from an observational study of UK primary school children. Schools in South West England. Four hundred and seven 9-11 year-old children (98% white British). Weight status was classified using BMI centiles using (1) sex and chronological age-matched referents and (2) sex and biological age-matched referents (based on % of predicted adult stature) relative to UK 1990 reference growth charts. For both approaches, children were classified as a normal weight if >2nd centile and <85thcentile, overweight if 85th and <95thcentiles, and obese if ≥95thcentile. Fifty-one children (12.5%) were overweight, and a further 51 obese (12.5%) according to standard chronological age-matched classifications. Adjustment for maturity resulted in 32% of overweight girls, and 15% of overweight boys being reclassified as a normal weight, and 11% and 8% of obese girls and boys, respectively, being reclassified as overweight. Early maturing children were 4.9 times more likely to be reclassified from overweight to normal weight than 'on-time' maturers (OR 95% CI 1.3 to 19). Incorporating assessments of maturational status into weight classification resulted in significant changes to the classification of early-maturing adolescents. Further research exploring the implications for objective health risk and well-being is needed. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Query Health: standards-based, cross-platform population health surveillance

PubMed Central

Klann, Jeffrey G; Buck, Michael D; Brown, Jeffrey; Hadley, Marc; Elmore, Richard; Weber, Griffin M; Murphy, Shawn N

2014-01-01

Objective Understanding population-level health trends is essential to effectively monitor and improve public health. The Office of the National Coordinator for Health Information Technology (ONC) Query Health initiative is a collaboration to develop a national architecture for distributed, population-level health queries across diverse clinical systems with disparate data models. Here we review Query Health activities, including a standards-based methodology, an open-source reference implementation, and three pilot projects. Materials and methods Query Health defined a standards-based approach for distributed population health queries, using an ontology based on the Quality Data Model and Consolidated Clinical Document Architecture, Health Quality Measures Format (HQMF) as the query language, the Query Envelope as the secure transport layer, and the Quality Reporting Document Architecture as the result language. Results We implemented this approach using Informatics for Integrating Biology and the Bedside (i2b2) and hQuery for data analytics and PopMedNet for access control, secure query distribution, and response. We deployed the reference implementation at three pilot sites: two public health departments (New York City and Massachusetts) and one pilot designed to support Food and Drug Administration post-market safety surveillance activities. The pilots were successful, although improved cross-platform data normalization is needed. Discussions This initiative resulted in a standards-based methodology for population health queries, a reference implementation, and revision of the HQMF standard. It also informed future directions regarding interoperability and data access for ONC's Data Access Framework initiative. Conclusions Query Health was a test of the learning health system that supplied a functional methodology and reference implementation for distributed population health queries that has been validated at three sites. PMID:24699371

Query Health: standards-based, cross-platform population health surveillance.

PubMed

Klann, Jeffrey G; Buck, Michael D; Brown, Jeffrey; Hadley, Marc; Elmore, Richard; Weber, Griffin M; Murphy, Shawn N

2014-01-01

Understanding population-level health trends is essential to effectively monitor and improve public health. The Office of the National Coordinator for Health Information Technology (ONC) Query Health initiative is a collaboration to develop a national architecture for distributed, population-level health queries across diverse clinical systems with disparate data models. Here we review Query Health activities, including a standards-based methodology, an open-source reference implementation, and three pilot projects. Query Health defined a standards-based approach for distributed population health queries, using an ontology based on the Quality Data Model and Consolidated Clinical Document Architecture, Health Quality Measures Format (HQMF) as the query language, the Query Envelope as the secure transport layer, and the Quality Reporting Document Architecture as the result language. We implemented this approach using Informatics for Integrating Biology and the Bedside (i2b2) and hQuery for data analytics and PopMedNet for access control, secure query distribution, and response. We deployed the reference implementation at three pilot sites: two public health departments (New York City and Massachusetts) and one pilot designed to support Food and Drug Administration post-market safety surveillance activities. The pilots were successful, although improved cross-platform data normalization is needed. This initiative resulted in a standards-based methodology for population health queries, a reference implementation, and revision of the HQMF standard. It also informed future directions regarding interoperability and data access for ONC's Data Access Framework initiative. Query Health was a test of the learning health system that supplied a functional methodology and reference implementation for distributed population health queries that has been validated at three sites. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Efficient randomization of biological networks while preserving functional characterization of individual nodes.

PubMed

Iorio, Francesco; Bernardo-Faura, Marti; Gobbi, Andrea; Cokelaer, Thomas; Jurman, Giuseppe; Saez-Rodriguez, Julio

2016-12-20

Networks are popular and powerful tools to describe and model biological processes. Many computational methods have been developed to infer biological networks from literature, high-throughput experiments, and combinations of both. Additionally, a wide range of tools has been developed to map experimental data onto reference biological networks, in order to extract meaningful modules. Many of these methods assess results' significance against null distributions of randomized networks. However, these standard unconstrained randomizations do not preserve the functional characterization of the nodes in the reference networks (i.e. their degrees and connection signs), hence including potential biases in the assessment. Building on our previous work about rewiring bipartite networks, we propose a method for rewiring any type of unweighted networks. In particular we formally demonstrate that the problem of rewiring a signed and directed network preserving its functional connectivity (F-rewiring) reduces to the problem of rewiring two induced bipartite networks. Additionally, we reformulate the lower bound to the iterations' number of the switching-algorithm to make it suitable for the F-rewiring of networks of any size. Finally, we present BiRewire3, an open-source Bioconductor package enabling the F-rewiring of any type of unweighted network. We illustrate its application to a case study about the identification of modules from gene expression data mapped on protein interaction networks, and a second one focused on building logic models from more complex signed-directed reference signaling networks and phosphoproteomic data. BiRewire3 it is freely available at https://www.bioconductor.org/packages/BiRewire/ , and it should have a broad application as it allows an efficient and analytically derived statistical assessment of results from any network biology tool.

Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia: part I--a method of manual documentary analysis.

PubMed

Ilic, Nina; Savic, Snezana; Siegel, Evan; Atkinson, Kerry; Tasic, Ljiljana

2012-12-01

Recent development of a wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Cohort 1 of the selected 18 high-tier regulatory documents from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) regulatory frameworks were subject to a manual documentary analysis. These documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Manual analysis included a terminology search. The occurrence, frequency, and interchangeable use of different terms and phrases were recorded in the manual documentary analysis. Despite obvious differences, manual documentary analysis revealed certain consistency in use of terminology across analyzed frameworks. Phrase search frequencies have shown less uniformity than the search of terms. Overall, the EMA framework's documents referred to "medicinal products" and "marketing authorization(s)," the FDA documents discussed "drug(s)" or "biologic(s)," and the TGA documents referred to "biological(s)." Although high-tier documents often use different terminology they share concepts and themes. Documents originating from the same source have more conjunction in their terminology although they belong to different frameworks (i.e., Good Clinical Practice requirements based on the Declaration of Helsinki, 1964). Automated (software-based) documentary analysis should be obtained for the conceptual and relational analysis.

Design of an embedded inverse-feedforward biomolecular tracking controller for enzymatic reaction processes.

PubMed

Foo, Mathias; Kim, Jongrae; Sawlekar, Rucha; Bates, Declan G

2017-04-06

Feedback control is widely used in chemical engineering to improve the performance and robustness of chemical processes. Feedback controllers require a 'subtractor' that is able to compute the error between the process output and the reference signal. In the case of embedded biomolecular control circuits, subtractors designed using standard chemical reaction network theory can only realise one-sided subtraction, rendering standard controller design approaches inadequate. Here, we show how a biomolecular controller that allows tracking of required changes in the outputs of enzymatic reaction processes can be designed and implemented within the framework of chemical reaction network theory. The controller architecture employs an inversion-based feedforward controller that compensates for the limitations of the one-sided subtractor that generates the error signals for a feedback controller. The proposed approach requires significantly fewer chemical reactions to implement than alternative designs, and should have wide applicability throughout the fields of synthetic biology and biological engineering.

Novel strategies to construct complex synthetic vectors to produce DNA molecular weight standards.

PubMed

Chen, Zhe; Wu, Jianbing; Li, Xiaojuan; Ye, Chunjiang; Wenxing, He

2009-05-01

DNA molecular weight standards (DNA markers, nucleic acid ladders) are commonly used in molecular biology laboratories as references to estimate the size of various DNA samples in electrophoresis process. One method of DNA marker production is digestion of synthetic vectors harboring multiple DNA fragments of known sizes by restriction enzymes. In this article, we described three novel strategies-sequential DNA fragment ligation, screening of ligation products by polymerase chain reaction (PCR) with end primers, and "small fragment accumulation"-for constructing complex synthetic vectors and minimizing the mass differences between DNA fragments produced from restrictive digestion of synthetic vectors. The strategy could be applied to construct various complex synthetic vectors to produce any type of low-range DNA markers, usually available commercially. In addition, the strategy is useful for single-step ligation of multiple DNA fragments for construction of complex synthetic vectors and other applications in molecular biology field.

Determination of non-ortho polychlorinated biphenyls in environmental Standard Reference Materials.

PubMed

Brubaker, W W; Schantz, M M; Wise, S A

2000-07-01

The concentrations of three non-ortho ("coplanar") polychlorinated biphenyls, 3,3',4,4'-tetrachlorobiphenyl (IUPAC PCB 77), 3,3',4,4',5-pentachlorobiphenyl (IUPAC PCB 126), and 3,3',4,4',5,5'-hexachlorobiphenyl (IUPAC PCB 169), were determined in five NIST Standard Reference Materials (SRMs) of environmental and biological interest. The measured levels were approximately between (0.2 to 1.3) ng/g in SRM 1588a (Organics in Cod Liver Oil), (0.3 to 9) ng/g in SRM 1944 (New York/New Jersey Waterway Sediment), (0.2 to 0.4) ng/g in SRM 1945 (Organics in Whale Blubber), (1 to 18) ng/g in SRM 2974 (Organics in Freeze-dried Mussel Tissue [Mytilus edulis]), and (0.1 to 0.4) ng/g in candidate SRM 1946 (Lake Superior Fish Tissue). PCB 169 was present at < 0.1 ng/g in SRMs 1944 and 2974.

[Research progress on breeding standard of medicinal animals and discussion on several key problems].

PubMed

Zhou, Yi-Quan; Qu, Xian-You; Yang, Guang; Li, Jun-de; Su, Yan; Li, Ying

2016-12-01

Medicinal animal breeding standards is regarded as the law to normalize relevant production that can guarantee the quality of traditional Chinese medicine of animal category. The article summarized the medicinal animal resources in our country and the present condition of medicinal animal breeding standards. It considered the current animal breeding standards system was in adequate, not only the quantity of breeding standards, the standard content and index were also uncomprehensive, which is not conducive to the scientific and orderly development and utilization of medicinal animal resources. The article pointed out that the development of the basic standards, environmental control, feed quality, raising management, inspection and quarantine should be included into the medicinal animal breeding standards, and the medicinal animal breeding standards content framework was introduced. Meanwhile, animal welfare, biological safety and file management should be concerned during the process of research. Hope the article has good reference value to medicinal animal breeding standards establishment and production management. Copyright© by the Chinese Pharmaceutical Association.

Requirements for facilities transferring or receiving select agents. Final rule.

PubMed

2001-08-31

CDC administers regulations that govern the transfer of certain biological agents and toxins ("select agents"). These regulations require entities that transfer or receive select agents to register with CDC and comply with biosafety standards contained in the Third Edition of the CDC/NIH publication "Biosafety in Microbiological and Biomedical Laboratories ("BMBL")." On October 28,1999, CDC published a Notice of Proposed Rulemaking ("NPRM") seeking both to revise the biosafety standards facilities must follow when handling select agents and to provide new biosecurity standards for such facilities. These new standards are contained in the Fourth Edition of BMBL, which the NPRM proposed to incorporate by reference, thereby replacing the Third Edition. No comments were received in response to this proposal. CDC is therefore amending its regulations to incorporate the Fourth Edition.

Collaborative study for the establishment of erythropoietin BRP batch 4.

PubMed

Burns, C; Bristow, A F; Daas, A; Costanzo, A

2015-01-01

The European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for erythropoietin (EPO) is used as a working standard for potency determination of EPO preparations by in vivo bioassay as prescribed in the Ph. Eur. monograph Erythropoietin concentrated solution (1316). The BRP batch 3 was calibrated in 2006 and its stocks are depleted. The European Directorate for the Quality of Medicines & HealthCare (EDQM) thus initiated a project to calibrate a replacement batch in International Units against the WHO 3(rd) International Standard (IS) for Erythropoietin, recombinant, for bioassay (11/170). A Ph. Eur. Chemical Reference Substance (CRS) was established recently for use as reference in some of the physicochemical tests prescribed in the monograph. Therefore, the EPO BRP batch 4 was only calibrated for the normocythaemic and polycythaemic mouse in vivo bioassays described in the Assay section of the Ph. Eur. monograph (1316). The collaborative study involved seven laboratories from Europe, the USA and South America. The results confirmed that the candidate BRP (cBRP) is suitable for use as a reference preparation in the potency determination of EPO medicinal products by bioassay (using the normocythaemic or polycythaemic mouse methods). The outcome of the study enabled the Ph. Eur. Commission to establish the proposed standard as erythropoietin BRP batch 4 in November 2014 for use as a reference preparation solely for the polycythaemic and normocythaemic mouse bioassay, with an assigned potency of 13 000 IU/vial. Furthermore, the potency of BRP3 was confirmed during the study, thus warranting a good continuity of the IU.

Setting nutrient thresholds to support an ecological assessment based on nutrient enrichment, potential primary production and undesirable disturbance.

PubMed

Devlin, Michelle; Painting, Suzanne; Best, Mike

2007-01-01

The EU Water Framework Directive recognises that ecological status is supported by the prevailing physico-chemical conditions in each water body. This paper describes an approach to providing guidance on setting thresholds for nutrients taking account of the biological response to nutrient enrichment evident in different types of water. Indices of pressure, state and impact are used to achieve a robust nutrient (nitrogen) threshold by considering each individual index relative to a defined standard, scale or threshold. These indices include winter nitrogen concentrations relative to a predetermined reference value; the potential of the waterbody to support phytoplankton growth (estimated as primary production); and detection of an undesirable disturbance (measured as dissolved oxygen). Proposed reference values are based on a combination of historical records, offshore (limited human influence) nutrient concentrations, literature values and modelled data. Statistical confidence is based on a number of attributes, including distance of confidence limits away from a reference threshold and how well the model is populated with real data. This evidence based approach ensures that nutrient thresholds are based on knowledge of real and measurable biological responses in transitional and coastal waters.

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).

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

A contemporary Colombian skeletal reference collection: A resource for the development of population specific standards.

PubMed

Sanabria-Medina, Cesar; González-Colmenares, Gretel; Restrepo, Hadaluz Osorio; Rodríguez, Juan Manuel Guerrero

2016-09-01

Several authors who have discussed human variability and its impact on the forensic identification of bodies pose the need for regional studies documenting the global variation of the attributes analyzed osteological characteristics that aid in establishing biological profile (sex, ancestry, biological age and height). This is primarily accomplished by studying documented human skeletal collections in order to investigate secular trends in skeletal development and aging, among others in the Colombian population. The purpose of this paper is to disclose the details of the new "Contemporary Colombian Skeletal Reference Collection" that currently comprises 600 identified skeletons of both sexes, who died between 2005 and 2008; and which contain information about their cause of death. This collection has infinite potential for research, open to the national and international community, and still has pending opportunities to address a variety of topics such as studies on osteopathology, bone trauma and taphonomic studies. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Computational Biology Methods for Characterization of Pluripotent Cells.

PubMed

Araúzo-Bravo, Marcos J

2016-01-01

Pluripotent cells are a powerful tool for regenerative medicine and drug discovery. Several techniques have been developed to induce pluripotency, or to extract pluripotent cells from different tissues and biological fluids. However, the characterization of pluripotency requires tedious, expensive, time-consuming, and not always reliable wet-lab experiments; thus, an easy, standard quality-control protocol of pluripotency assessment remains to be established. Here to help comes the use of high-throughput techniques, and in particular, the employment of gene expression microarrays, which has become a complementary technique for cellular characterization. Research has shown that the transcriptomics comparison with an Embryonic Stem Cell (ESC) of reference is a good approach to assess the pluripotency. Under the premise that the best protocol is a computer software source code, here I propose and explain line by line a software protocol coded in R-Bioconductor for pluripotency assessment based on the comparison of transcriptomics data of pluripotent cells with an ESC of reference. I provide advice for experimental design, warning about possible pitfalls, and guides for results interpretation.

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

The establishment of tocopherol reference intervals for Hungarian adult population using a validated HPLC method.

PubMed

Veres, Gábor; Szpisjak, László; Bajtai, Attila; Siska, Andrea; Klivényi, Péter; Ilisz, István; Földesi, Imre; Vécsei, László; Zádori, Dénes

2017-09-01

Evidence suggests that decreased α-tocopherol (the most biologically active substance in the vitamin E group) level can cause neurological symptoms, most likely ataxia. The aim of the current study was to first provide reference intervals for serum tocopherols in the adult Hungarian population with appropriate sample size, recruiting healthy control subjects and neurological patients suffering from conditions without symptoms of ataxia, myopathy or cognitive deficiency. A validated HPLC method applying a diode array detector and rac-tocol as internal standard was utilized for that purpose. Furthermore, serum cholesterol levels were determined as well for data normalization. The calculated 2.5-97.5% reference intervals for α-, β/γ- and δ-tocopherols were 24.62-54.67, 0.81-3.69 and 0.29-1.07 μm, respectively, whereas the tocopherol/cholesterol ratios were 5.11-11.27, 0.14-0.72 and 0.06-0.22 μmol/mmol, respectively. The establishment of these reference intervals may improve the diagnostic accuracy of tocopherol measurements in certain neurological conditions with decreased tocopherol levels. Moreover, the current study draws special attention to the possible pitfalls in the complex process of the determination of reference intervals as well, including the selection of study population, the application of internal standard and method validation and the calculation of tocopherol/cholesterol ratios. Copyright © 2017 John Wiley & Sons, Ltd.

Discrimination of Biological and Chemical Threat Simulants in Residue Mixtures on Multiple Substrates

DTIC Science & Technology

2011-02-18

environmental interferents selected for this study included dolomitic limestone (Lime, NIST Standard Reference Materials, Catalog No. SRM 88b) and ovalbumin...emission lines due solely to substrates or interferents can be ignored. As in previous studies by our group, the background-corrected peak ...calculated by adding the intensi- ties of the emission lines at 486 and 656 nm); the summed intensities were normalized to the total peak intensity of the

Determination of metallothionein in biological fluids using enzyme-linked immunoassay with commercial antibody.

PubMed

Milnerowicz, Halina; Bizoń, Anna

2010-01-01

Metallothionein (MT) is a low molecular weight cysteine-rich protein with a number of roles in the pro/antioxidant balance and homeostasis of essential metals, such as zinc and copper, and in the detoxification of heavy metals, such as cadmium and mercury. Until now, detection of metallothionein in biological fluids remained difficult because of a lack of a broadly reactive commercial test. Meaningful comparison of the values of metallothionein concentrations reported by different authors using their specific isolation procedures and different conditions of enzyme-linked immunoassay is difficult due to the absence of a reference material for metallothionein. Therefore in the present study, we describe a quantitative assay for metallothionein in biological fluids such as plasma and urine performed by a direct enzyme-linked immunoassay using a commercially available monoclonal mouse anti-metallothionein clone E9 antibody and commercial standards of metallothionein from rabbit liver and a custom preparation of metallothionein from human liver. The sensitivity of the assay for the standard containing two isoforms MT-I and MT-II from human liver was 140 pg/well. The reactivity of the commercial standards and standards containing two isoforms MT-I and MT-II isolated from human liver in our laboratory with a commercial monoclonal mouse anti-metallothionein clone E9 antibody were similar. This suggests that the described ELISA test can be useful for determination of metallothionein concentration in biological fluids. The concentrations of metallothionein in human plasma, erythrocyte lysate and in urine of smoking and non-smoking healthy volunteers are reported. Tobacco smoking increases the extracellular metallothionein concentration (plasma and urine) but does not affect the intracellular concentration (erythrocyte lysate).

[Preparation and certification of mussel reference material for organochlorine pesticides and polychlorinated biphenyls using isotope dilution-high resolution mass spectrometry].

PubMed

Lu, Xianbo; Chen, Jiping; Wang, Shuqiu; Zou, Lili; Tian, Yuzeng; Ni, Yuwen; Su, Fan

2012-09-01

A method for the preparation and certification of the reference material of organochlorine pesticides (OCPs) and polychlorinated biphenyls (PCBs) in mussel tissue is described. The mussel tissue from Dalian Bay was frozen-dried, comminuted, sieved, homogenized, packaged, and sterilized by 60Co radiation sterilization in turn. The certified values for 18 OCPs and 16 PCBs were determined by high resolution gas chromatography/high resolution mass spectrometry (HRGC/HRMS) using isotope dilution and internal standard quantitation techniques. The certified values were validated and given based on seven accredited laboratories, and these values are traceable to the SI (international system of units) through gravimetrically prepared standards of established purity and measurement intercomparisons. The certified values of PCBs and OCPs in mussel span 4 orders of magnitude with a relative uncertainty of about 10%. This material is a natural biological material with confirmed good homogeneity and stability, and it was approved as the grade "primary reference material" (GBW10069) in June 2012 in China. This reference material provided necessary quality control products for our country to implement the Stockholm Treaty on the monitoring of persistent organic pollutants (POPs). The material is intended to be used for the method validation and quality control in the determination of OCPs and PCBs in biota samples.

Clinically referred children and adolescents: fathers, family constellations, and other demographic factors.

PubMed

Phares, V; Lum, J J

1997-06-01

Investigated the likelihood that clinically referred youth have contact with their biological father. Family demographics such as family constellation, race/ethnicity, and socioeconomic status were also explored. Based on 356 consecutive therapy and assessment referrals to an outpatient clinic, slightly less than half (42.4%) of the children and adolescents referred due to psychological problems and more than half (67.8%) of the youth referred due to learning difficulties lived with both their biological mother and biological father. For those who did not live with both of their biological parents, 40.0% and 56.0%, respectively, had regular face-to-face contact with both biological parents. These figures suggest that, although the percentages of intact families are somewhat lower in treatment samples than in the general population or in a sample referred for learning difficulties, close to half of clinically referred youth continue to live with both of their biological parents. Future directions for the inclusion of fathers in clinical research are discussed.

Establishment of replacement batches for heparin low-molecular-mass for calibration CRS, and the International Standard Low Molecular Weight Heparin for Calibration.

PubMed

Mulloy, B; Heath, A; Behr-Gross, M-E

2007-12-01

An international collaborative study involving fourteen laboratories has taken place, organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) with National Institute for Biological Standards & Control (NIBSC) (in its capacity as a World Health Organisation (WHO) Laboratory for Biological Standardisation) to provide supporting data for the establishment of replacement batches of Heparin Low-Molecular-Mass (LMM) for Calibration Chemical Reference Substance (CRS), and of the International Reference Reagent (IRR) Low Molecular Weight Heparin for Molecular Weight Calibration. A batch of low-molecular-mass heparin was donated to the organisers and candidate preparations of freeze-dried heparin were produced at NIBSC and EDQM. The establishment study was organised in two phases: a prequalification (phase 1, performed in 3 laboratories in 2005) followed by an international collaborative study (phase 2). In phase 2, started in March 2006, molecular mass parameters were determined for seven different LMM heparin samples using the current CRS batch and two batches of candidate replacement material with a defined number average relative molecular mass (Mn) of 3,700, determined in phase 1. The values calculated using the candidates as standard were systematically different from values calculated using the current batch with its assigned number-average molecular mass (Mna) of 3,700. Using raw data supplied by participants, molecular mass parameters were recalculated using the candidates as standard with values for Mna of 3,800 and 3,900. Values for these parameters agreed more closely with those calculated using the current batch supporting the fact that the candidates, though similar to batch 1 in view of the production processes used, differ slightly in terms of molecular mass distribution. Therefore establishment of the candidates was recommended with an assigned Mna value of 3,800 that is both consistent with phase 1 results and guarantees continuity with the current CRS batch. In phase 2, participants also determined molecular weight parameters for the seven different LMM heparin samples using both the 1st IRR (90/686) and its Broad Standard Table and the candidate World Health Organization (WHO) 2nd International Standard (05/112) (2nd IS) using a Broad Standard Table established in phase 1. Mean molecular weights calculated using 2nd IS were slightly higher than with 1st IRR, and participants in the study indicated that this systematic difference precluded establishment of 2nd IS with the table supplied. A replacement Broad Standard Table has been devised on the basis of the central recalculations of raw data supplied by participants; this table gives improved agreement between values derived using the 1st IRR and the candidate 2nd IS. On the basis of this study a recommendation was made for the establishment of 2nd IS and its proposed Broad Standard Table as a replacement for the 1st International Reference Reagent Low Molecular Weight Heparin for Molecular Weight Calibration. Unlike the 1st IRR however, the candidate material 2nd IS is not suitable for use with the method of Nielsen. The candidate materials were established as heparin low-molecular-mass for calibration batches 2 and 3 by the Ph. Eur. Commission in March 2007 and as 2nd IS low-molecular-weight heparin for molecular weight calibration (05/112) by the Expert Committee on Biological Standardization in November 2007.

Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the U.S., and Australia: Part I—A Method of Manual Documentary Analysis

PubMed Central

Savic, Snezana; Siegel, Evan; Atkinson, Kerry; Tasic, Ljiljana

2012-01-01

Recent development of a wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Cohort 1 of the selected 18 high-tier regulatory documents from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) regulatory frameworks were subject to a manual documentary analysis. These documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Manual analysis included a terminology search. The occurrence, frequency, and interchangeable use of different terms and phrases were recorded in the manual documentary analysis. Despite obvious differences, manual documentary analysis revealed certain consistency in use of terminology across analyzed frameworks. Phrase search frequencies have shown less uniformity than the search of terms. Overall, the EMA framework's documents referred to “medicinal products” and “marketing authorization(s),” the FDA documents discussed “drug(s)” or “biologic(s),” and the TGA documents referred to “biological(s).” Although high-tier documents often use different terminology they share concepts and themes. Documents originating from the same source have more conjunction in their terminology although they belong to different frameworks (i.e., Good Clinical Practice requirements based on the Declaration of Helsinki, 1964). Automated (software-based) documentary analysis should be obtained for the conceptual and relational analysis. PMID:23283551

Collaborative study for the establishment of the Ph. Eur. Hepatitis E virus RNA for NAT testing biological reference preparation batch 1.

PubMed

Baylis, S A; Terao, E; Blümel, J; Hanschmann, K-M O

2017-01-01

A new European Pharmacopoeia (Ph. Eur.) biological reference preparation (BRP) had to be established further to the decision to include nucleic acid testing (NAT) for the detection of hepatitis E virus (HEV) RNA in the monograph Human plasma (pooled and treated for virus inactivation) (1646). To this purpose, an international collaborative study was launched in the framework of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Commission of the European Union (EU). The study was run in conjunction with the establishment of the 1 st World Health Organization (WHO) international reference panel (IRP) for hepatitis E virus RNA genotypes (8578/13). Twenty-three laboratories used in-house developed and commercially available assays to calibrate a lyophilised candidate BRP prepared from a HEV 3f strain positive human plasma against the 1 st WHO International Standard (IS) for HEV RNA (6329/10). Results from quantitative and qualitative assays were in good agreement and were combined to calculate an assigned potency. Real-time stability studies indicated that the candidate BRP is very stable at lower temperatures and is thus suitable for long-term use. Based on these results, in February 2016, the Ph. Eur. Commission adopted the candidate material as the hepatitis E virus RNA for NAT testing BRP batch 1, with an assigned unitage of 2.1 × 10 4 IU/vial (4.32 log 10 IU/vial).

EDQM biological reference preparation for rabies vaccine (inactivated) for veterinary use.

PubMed

Daas, A; Bruckner, L; Milne, C

2015-01-01

Rabies is a deadly zoonotic disease. Control of rabies in animals by vaccination is an important strategy to protect humans from infection and control the spread of the disease. Requirements for the quality control of rabies vaccines (inactivated) for veterinary use include an in vivo quantitative potency determination as outlined in the Ph. Eur. monograph 0451. Performance of this assay requires a reference preparation calibrated in International Units (IU). A European Pharmacopeia (Ph. Eur.) Biological Reference Preparation (BRP) for rabies vaccines (inactivated) for veterinary use, calibrated in IU, has been established for this purpose. Due to the dwindling stocks of the current batch (batch 4) of Ph. Eur. BRP for rabies vaccines (inactivated) for veterinary use, a collaborative study was run as part of the EDQM Biological Standardisation Programme to establish BRP batch 5. Ten laboratories, including Official Medicines Control Laboratories and manufacturers, participated. The candidate BRP5 was assayed against the 6(th) International Standard for rabies vaccine using the in vivo vaccination-challenge assay (monograph 0451) to assign a potency value. The candidate was also compared to BRP batch 4 to establish continuity. Taking into account the results from the comparisons a potency of 10 IU/vial was assigned and in March 2015 the Ph. Eur. Commission adopted the material as Ph. Eur. BRP for rabies vaccines (inactivated) for veterinary use batch 5. In addition to the in vivo assay 3 laboratories tested the candidate material using their in-house in vitro assays for information.

Evaluation of ability of reference toxicity tests to identify stress in laboratory populations of the amphipod Hyalella azteca

USGS Publications Warehouse

McNulty, E.W.; Dwyer, F.J.; Ellersieck, Mark R.; Greer, E.I.; Ingersoll, C.G.; Rabeni, C.F.

1999-01-01

Standard methods for conducting toxicity tests imply that the condition of test organisms can be established using reference toxicity tests. However, only a limited number of studies have evaluated whether reference toxicity tests can actually be used to determine if organisms are in good condition at the start of a test. We evaluated the ability of reference toxicants to identify stress associated with starvation in laboratory populations of the amphipod Hyalella azteca using acute toxicity tests and four reference toxicants: KCl, CdCl2, sodium pentachlorophenate (NaPCP), and carbaryl. Stress associated with severe starvation was observed with exposure of amphipods to carbaryl or NaPCP but not with exposure to KCl or CdCl2 (i.e., lower LC50 with severe starvation). Although the LC50s for NaPCP and carbaryl were statistically different between starved and fed amphipods, this difference may not be biologically significant given the variability expected in acute lethality tests. Stress associated with sieving, heat shock, or cold shock of amphipods before the start of a test was not evident with exposure to carbaryl or KCl as reference toxicants. The chemicals evaluated in this study provided minimal information about the condition of the organisms used to start a toxicity test. Laboratories should periodically perform reference toxicity tests to assess the sensitivity of life stages or strains of test organisms. However, use of other test acceptability criteria required in standard methods such as minimum survival, growth, or reproduction of organisms in the control treatment at the end of a test, provides more useful information about the condition of organisms used to start a test compared to data generated from reference toxicity tests.

Collaborative study for the establishment of the 2(nd) International Standard for Bleomycin Complex A2/B2.

PubMed

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

2015-01-01

Organization (WHO) International Standard (IS) for bleomycin complex A2/B2. Eight 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 1(st) IS for bleomycin complex A2/B2 was used as a reference. Based on the results of the study, the 2(nd) IS for bleomycin complex A2/B2 was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2014 with an assigned potency of 12 500 International Units (IU) per vial. The 2(nd) IS for bleomycin complex A2/B2 is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).

Standardizing CT lung density measure across scanner manufacturers.

PubMed

Chen-Mayer, Huaiyu Heather; Fuld, Matthew K; Hoppel, Bernice; Judy, Philip F; Sieren, Jered P; Guo, Junfeng; Lynch, David A; Possolo, Antonio; Fain, Sean B

2017-03-01

Computed Tomography (CT) imaging of the lung, reported in Hounsfield Units (HU), can be parameterized as a quantitative image biomarker for the diagnosis and monitoring of lung density changes due to emphysema, a type of chronic obstructive pulmonary disease (COPD). CT lung density metrics are global measurements based on lung CT number histograms, and are typically a quantity specifying either the percentage of voxels with CT numbers below a threshold, or a single CT number below which a fixed relative lung volume, nth percentile, falls. To reduce variability in the density metrics specified by CT attenuation, the Quantitative Imaging Biomarkers Alliance (QIBA) Lung Density Committee has organized efforts to conduct phantom studies in a variety of scanner models to establish a baseline for assessing the variations in patient studies that can be attributed to scanner calibration and measurement uncertainty. Data were obtained from a phantom study on CT scanners from four manufacturers with several protocols at various tube potential voltage (kVp) and exposure settings. Free from biological variation, these phantom studies provide an assessment of the accuracy and precision of the density metrics across platforms solely due to machine calibration and uncertainty of the reference materials. The phantom used in this study has three foam density references in the lung density region, which, after calibration against a suite of Standard Reference Materials (SRM) foams with certified physical density, establishes a HU-electron density relationship for each machine-protocol. We devised a 5-step calibration procedure combined with a simplified physical model that enabled the standardization of the CT numbers reported across a total of 22 scanner-protocol settings to a single energy (chosen at 80 keV). A standard deviation was calculated for overall CT numbers for each density, as well as by scanner and other variables, as a measure of the variability, before and after the standardization. In addition, a linear mixed-effects model was used to assess the heterogeneity across scanners, and the 95% confidence interval of the mean CT number was evaluated before and after the standardization. We show that after applying the standardization procedures to the phantom data, the instrumental reproducibility of the CT density measurement of the reference foams improved by more than 65%, as measured by the standard deviation of the overall mean CT number. Using the lung foam that did not participate in the calibration as a test case, a mixed effects model analysis shows that the 95% confidence intervals are [-862.0 HU, -851.3 HU] before standardization, and [-859.0 HU, -853.7 HU] after standardization to 80 keV. This is in general agreement with the expected CT number value at 80 keV of -855.9 HU with 95% CI of [-857.4 HU, -854.5 HU] based on the calibration and the uncertainty in the SRM certified density. This study provides a quantitative assessment of the variations expected in CT lung density measures attributed to non-biological sources such as scanner calibration and scanner x-ray spectrum and filtration. By removing scanner-protocol dependence from the measured CT numbers, higher accuracy and reproducibility of quantitative CT measures were attainable. The standardization procedures developed in study may be explored for possible application in CT lung density clinical data. © 2017 American Association of Physicists in Medicine.

CHEMICAL STRUCTURE INDEXING OF TOXICITY DATA ON ...

EPA Pesticide Factsheets

Standardized chemical structure annotation of public toxicity databases and information resources is playing an increasingly important role in the 'flattening' and integration of diverse sets of biological activity data on the Internet. This review discusses public initiatives that are accelerating the pace of this transformation, with particular reference to toxicology-related chemical information. Chemical content annotators, structure locator services, large structure/data aggregator web sites, structure browsers, International Union of Pure and Applied Chemistry (IUPAC) International Chemical Identifier (InChI) codes, toxicity data models and public chemical/biological activity profiling initiatives are all playing a role in overcoming barriers to the integration of toxicity data, and are bringing researchers closer to the reality of a mineable chemical Semantic Web. An example of this integration of data is provided by the collaboration among researchers involved with the Distributed Structure-Searchable Toxicity (DSSTox) project, the Carcinogenic Potency Project, projects at the National Cancer Institute and the PubChem database. Standardizing chemical structure annotation of public toxicity databases

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2011-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

Assessing Ecological Impacts of Shrimp and Sewage Effluent: Biological Indicators with Standard Water Quality Analyses

NASA Astrophysics Data System (ADS)

Jones, A. B.; O'Donohue, M. J.; Udy, J.; Dennison, W. C.

2001-01-01

Despite evidence linking shrimp farming to several cases of environmental degradation, there remains a lack of ecologically meaningful information about the impacts of effluent on receiving waters. The aim of this study was to determine the biological impact of shrimp farm effluent, and to compare and distinguish its impacts from treated sewage effluent. Analyses included standard water quality/sediment parameters, as well as biological indicators including tissue nitrogen (N) content, stable isotope ratio of nitrogen (δ 15N), and amino acid composition of inhabitant seagrasses, mangroves and macroalgae. The study area consisted of two tidal creeks, one receiving effluent from a sewage treatment plant and the other from an intensive shrimp farm. The creeks discharged into the western side of Moreton Bay, a sub-tropical coastal embayment on the east coast of Australia. Characterization of water quality revealed significant differences between the creeks, and with unimpacted eastern Moreton Bay. The sewage creek had higher concentrations of dissolved nutrients (predominantly NO-3/NO-2 and PO3-4, compared to NH+4 in the shrimp creek). In contrast, the shrimp creek was more turbid and had higher phytoplankton productivity. Beyond 750 m from the creek mouths, water quality parameters were indistinguishable from eastern Moreton Bay values. Biological indicators detected significant impacts up to 4 km beyond the creek mouths (reference site). Elevated plant δ 15N values ranged from 10·4-19·6‰ at the site of sewage discharge to 2·9-4·5‰ at the reference site. The free amino acid concentration and composition of seagrass and macroalgae was used to distinguish between the uptake of sewage and shrimp derived N. Proline (seagrass) and serine (macroalgae) were high in sewage impacted plants and glutamine (seagrass) and alanine (macroalgae) were high in plants impacted by shrimp effluent. The δ 15N isotopic signatures and free amino acid composition of inhabitant flora indicated that sewage N extended further from the creek mouths than shrimp N. The combination of physical/chemical and biological indicators used in this study was effective in distinguishing the composition and subsequent impacts of aquaculture and sewage effluent on the receiving waters.

A Large-Scale, Multiagency Approach to Defining a Reference Network for Pacific Northwest Streams

NASA Astrophysics Data System (ADS)

Miller, Stephanie; Eldred, Peter; Muldoon, Ariel; Anlauf-Dunn, Kara; Stein, Charlie; Hubler, Shannon; Merrick, Lesley; Haxton, Nick; Larson, Chad; Rehn, Andrew; Ode, Peter; Vander Laan, Jake

2016-12-01

Aquatic monitoring programs vary widely in objectives and design. However, each program faces the unifying challenge of assessing conditions and quantifying reasonable expectations for measured indicators. A common approach for setting resource expectations is to define reference conditions that represent areas of least human disturbance or most natural state of a resource characterized by the range of natural variability across a region of interest. Identification of reference sites often relies heavily on professional judgment, resulting in varying and unrepeatable methods. Standardized methods for data collection, site characterization, and reference site selection facilitate greater cooperation among assessment programs and development of assessment tools that are readily shareable and comparable. We illustrate an example that can serve the broader global monitoring community on how to create a consistent and transparent reference network for multiple stream resource agencies. We provide a case study that offers a simple example of how reference sites can be used, at the landscape level, to link upslope management practices to a specific in-channel response. We found management practices, particularly areas with high road densities, have more fine sediments than areas with fewer roads. While this example uses data from only one of the partner agencies, if data were collected in a similar manner they can be combined and create a larger, more robust dataset. We hope that this starts a dialog regarding more standardized ways through inter-agency collaborations to evaluate data. Creating more consistency in physical and biological field protocols will increase the ability to share data.

Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa, Canada, 14 May 2012.

PubMed

Kay, Jonathan; Feagan, Brian G; Guirguis, Micheal S; Keystone, Edward C; Klein, Agnes V; Lubiniecki, Anthony S; Mould, Diane R; Nyarko, Kwasi A; Ridgway, Anthony A G; Trudeau, Maureen E; Wang, Jian

2012-11-01

In May 2012, Health Canada and other participants held a National Summit on Subsequent Entry Biologics (SEBs). Health Canada released a guidance document in March 2010 describing policy positions and data requirements for approval of SEBs. While Health Canada and health agencies in other regulatory jurisdictions are aligned on many scientific principles related to biosimilar drugs, Health Canada's specific requirements may not be widely understood by many Canadian stakeholders. The Summit provided an opportunity for education and dialog among physicians who prescribe biologics, provincial payers, and industry on the following topics: preclinical and clinical comparability studies; manufacturing and other product differences; extrapolation of indications; substitution and interchangeability of SEBs with reference biologic drugs in clinical practice; payers' current perspective; pharmacovigilance and naming. It is anticipated that the consensus reached at this meeting will further educate Canadian healthcare professionals, provincial payers, and insurers about the appropriate use of SEBs, and may be of general interest to others internationally. Copyright © 2012 The International Alliance for Biological Standardization. All rights reserved.

Assessment of genotoxic exposure in Swedish coke-oven work by different methods of biological monitoring.

PubMed

Reuterwall, C; Aringer, L; Elinder, C G; Rannug, A; Levin, J O; Juringe, L; Onfelt, A

1991-04-01

This study evaluated the results of several biological methods used simultaneously to monitor coke-oven work. Blood samples from 44 male coke-oven workers and 48 male referents, matched for age and smoking/snuff consumption, were examined for cytogenetic damage in lymphocytes. Urinary thioether excretion was determined for 62, and urine mutagenicity for 31, of the subjects, who followed a standardized diet during the urine sampling. Exposure to polycyclic aromatic hydrocarbons varied with work task, the ambient air levels of benzo[a]pyrene sometimes exceeding 5 micrograms/m3. Cytogenetic damage, urine mutagenicity, and thioether excretion did not differ between the groups. The smokers, however, had significantly higher sister chromatid exchange frequencies, urine mutagenicity, and thioether excretion than the nonsmokers. The absence of biological indications of genotoxic exposure was unexpected and indicates that the studied methods are not adequate to assess the carcinogenic risks of Swedish coke-oven workers.

Microwave acid digestion and preconcentration neutron activation analysis of biological and diet samples for iodine.

PubMed

Rao, R R; Chatt, A

1991-07-01

A simple preconcentration neutron activation analysis (PNAA) method has been developed for the determination of low levels of iodine in biological and nutritional materials. The method involves dissolution of the samples by microwave digestion in the presence of acids in closed Teflon bombs and preconcentration of total iodine, after reduction to iodide with hydrazine sulfate, by coprecipitation with bismuth sulfide. The effects of different factors such as acidity, time for complete precipitation, and concentrations of bismuth, sulfide, and diverse ions on the quantitative recovery of iodide have been studied. The absolute detection limit of the PNAA method is 5 ng of iodine. Precision of measurement, expressed in terms of relative standard deviation, is about 5% at 100 ppb and 10% at 20 ppb levels of iodine. The PNAA method has been applied to several biological reference materials and total diet samples.

The role of chemotherapy in the treatment of malignant astrocytomas.

PubMed

Mathieu, David; Fortin, David

2006-05-01

Malignant astrocytomas are aggressive neoplasms with a dismal prognosis despite optimal treatment. Maximal resective surgery is traditionally complemented by radiation therapy. Chemotherapy is now used on patients as initial therapy when their functional status is congruent with further treatment. The classic agents used are nitrosoureas, but temozolomide has taken the front seat recently, with recent data demonstrating increased survival when this agent is used concurrently with radiation therapy in newly diagnosed glioblastoma patients. A new class of agents, refered to as biological modifiers, are increasingly used in clinical trials in an effort to affect the intrinsic biologic aberrations harboured by tumor cells. These drugs comprise differentiation agents, anti-angiogenic agents, matrix-metalloproteinase inhibitors and signal transduction inhibitors, among others. This article reviews the standard cytotoxic agents that have been used to treat malignant astrocytomas, and the different combination regimens offering promise. In addition, recent advances with biological modifiers are also discussed.

LC-PDA-ESI/MS identification of the phenolic components of three compositae spices: chamomile, tarragon, and Mexican arnica.

PubMed

Lin, Long-Ze; Harnly, James M

2012-06-01

Chamomile (Matricaria chamomilla L.), tarragon (Artemisia dracunculus L.) and Mexican arnica (Heterotheca inuoides) are common compositae spices and herbs found in the US market. They contain flavonoids and hydroxycinnamates that are potentially beneficial to human health. A standardized LC-PDA-ESI/MS profiling method was used to identify 51 flavonoids and 17 hydroxycinnamates. Many of the identifications were confirmed with authentic standards or through references in the literature or the laboratory's database. More than half of the phenol compounds for each spice had not been previously reported. The phenolic profile can be used for plant authentication and to correlate with biological activities.

LC-PDA-ESI/MS Identification of the Phenolic Components of Three Compositae Spices: Chamomile, Tarragon, and Mexican Arnica

PubMed Central

Harnly, James M.

2013-01-01

Chamomile (Matricaria chamomilla L.), tarragon (Artemisia dracunculus L.) and Mexican arnica (Heterotheca inuoides) are common compositae spices and herbs found in the US market. They contain flavonoids and hydroxycinnamates that are potentially beneficial to human health. A standardized LC-PDA-ESI/MS profiling method was used to identify 51 flavonoids and 17 hydroxycinnamates. Many of the identifications were confirmed with authentic standards or through references in the literature or the laboratory’s database. More than half of the phenol compounds for each spice had not been previously reported. The phenolic profile can be used for plant authentication and to correlate with biological activities. PMID:22816299

A gene-signature progression approach to identifying candidate small-molecule cancer therapeutics with connectivity mapping.

PubMed

Wen, Qing; Kim, Chang-Sik; Hamilton, Peter W; Zhang, Shu-Dong

2016-05-11

Gene expression connectivity mapping has gained much popularity recently with a number of successful applications in biomedical research testifying its utility and promise. Previously methodological research in connectivity mapping mainly focused on two of the key components in the framework, namely, the reference gene expression profiles and the connectivity mapping algorithms. The other key component in this framework, the query gene signature, has been left to users to construct without much consensus on how this should be done, albeit it has been an issue most relevant to end users. As a key input to the connectivity mapping process, gene signature is crucially important in returning biologically meaningful and relevant results. This paper intends to formulate a standardized procedure for constructing high quality gene signatures from a user's perspective. We describe a two-stage process for making quality gene signatures using gene expression data as initial inputs. First, a differential gene expression analysis comparing two distinct biological states; only the genes that have passed stringent statistical criteria are considered in the second stage of the process, which involves ranking genes based on statistical as well as biological significance. We introduce a "gene signature progression" method as a standard procedure in connectivity mapping. Starting from the highest ranked gene, we progressively determine the minimum length of the gene signature that allows connections to the reference profiles (drugs) being established with a preset target false discovery rate. We use a lung cancer dataset and a breast cancer dataset as two case studies to demonstrate how this standardized procedure works, and we show that highly relevant and interesting biological connections are returned. Of particular note is gefitinib, identified as among the candidate therapeutics in our lung cancer case study. Our gene signature was based on gene expression data from Taiwan female non-smoker lung cancer patients, while there is evidence from independent studies that gefitinib is highly effective in treating women, non-smoker or former light smoker, advanced non-small cell lung cancer patients of Asian origin. In summary, we introduced a gene signature progression method into connectivity mapping, which enables a standardized procedure for constructing high quality gene signatures. This progression method is particularly useful when the number of differentially expressed genes identified is large, and when there is a need to prioritize them to be included in the query signature. The results from two case studies demonstrate that the approach we have developed is capable of obtaining pertinent candidate drugs with high precision.

Standardized protocols for quality control of MRM-based plasma proteomic workflows.

PubMed

Percy, Andrew J; Chambers, Andrew G; Smith, Derek S; Borchers, Christoph H

2013-01-04

Mass spectrometry (MS)-based proteomics is rapidly emerging as a viable technology for the identification and quantitation of biological samples, such as human plasma--the most complex yet commonly employed biofluid in clinical analyses. The transition from a qualitative to quantitative science is required if proteomics is going to successfully make the transition to a clinically useful technique. MS, however, has been criticized for a lack of reproducibility and interlaboratory transferability. Currently, the MS and plasma proteomics communities lack standardized protocols and reagents to ensure that high-quality quantitative data can be accurately and precisely reproduced by laboratories across the world using different MS technologies. Toward addressing this issue, we have developed standard protocols for multiple reaction monitoring (MRM)-based assays with customized isotopically labeled internal standards for quality control of the sample preparation workflow and the MS platform in quantitative plasma proteomic analyses. The development of reference standards and their application to a single MS platform is discussed herein, along with the results from intralaboratory tests. The tests highlighted the importance of the reference standards in assessing the efficiency and reproducibility of the entire bottom-up proteomic workflow and revealed errors related to the sample preparation and performance quality and deficits of the MS and LC systems. Such evaluations are necessary if MRM-based quantitative plasma proteomics is to be used in verifying and validating putative disease biomarkers across different research laboratories and eventually in clinical laboratories.

The pPSU Plasmids for Generating DNA Molecular Weight Markers.

PubMed

Henrici, Ryan C; Pecen, Turner J; Johnston, James L; Tan, Song

2017-05-26

Visualizing nucleic acids by gel electrophoresis is one of the most common techniques in molecular biology, and reference molecular weight markers or ladders are commonly used for size estimation. We have created the pPSU1 & pPSU2 pair of molecular weight marker plasmids which produce both 100 bp and 1 kb DNA ladders when digested with two common restriction enzymes. The 100 bp ladder fragments have been optimized to migrate appropriately on both agarose and native polyacrylamide, unlike many currently available DNA ladders. Sufficient plasmid DNA can be isolated from 100 ml E. coli cultures for the two plasmids to produce 100 bp or 1 kb ladders for 1000 gels. As such, the pPSU1 and pPSU2 plasmids provide reference fragments from 50 to 10000 bp at a fraction of the cost of commercial DNA ladders. The pPSU1 and pPSU2 plasmids are available without licensing restrictions to nonprofit academic users, affording freely available high-quality, low-cost molecular weight standards for molecular biology applications.

The Concept of Biosimilars: From Characterization to Evolution-A Narrative Review.

PubMed

Farhat, Fadi; Torres, Alfredo; Park, Wungki; de Lima Lopes, Gilberto; Mudad, Raja; Ikpeazu, Chukwuemeka; Abi Aad, Simon

2018-03-01

Biologic agents are currently the fastest emerging segment of drug expenditure. Unlike chemically synthesized small-molecule drugs, biologics are more complex, medicinal products produced by a living organism. They have become part of the standard of care in the treatment of a large variety of diseases, such as growth disorders, autoimmune diseases, cancer, cardiovascular illnesses, hemophilia, and rare genetic conditions, to name a few. Biosimilars, which are copies of biologics that are highly similar, were introduced in the market with an aim to offer efficacy that is not clinically different from the originator or reference product, at lower prices. We aim to clarify the concept of biosimilar, from definitions, history, market entry, challenges faced, and future evolution. For that purpose, we performed a literature search on the sites of the medicines regulatory agencies and PubMed from 1990 to 2014 with the keywords "biosimilars," "market," and "regulatory." In 2006, the first biosimilar, somatropin [rDNA origin], was marketed and led the way for biosimilar drug manufacturing. As a result, manufacturers have entered a diversified competition, facing challenges in manufacturing these complex agents, such as immunogenicity and efficiency. Biosimilars are set to evolve differently in various markets, namely the U.S., Japan, the European Union, and the "pharmerging" economies. This article highlights the importance of biosimilars, as a cost-cutting strategy, in the delivery of state-of-the-art health care in developing countries, at a fraction of what a reference biological agent would cost. © AlphaMed Press 2017.

GlycoRDF: an ontology to standardize glycomics data in RDF

PubMed Central

Ranzinger, Rene; Aoki-Kinoshita, Kiyoko F.; Campbell, Matthew P.; Kawano, Shin; Lütteke, Thomas; Okuda, Shujiro; Shinmachi, Daisuke; Shikanai, Toshihide; Sawaki, Hiromichi; Toukach, Philip; Matsubara, Masaaki; Yamada, Issaku; Narimatsu, Hisashi

2015-01-01

Motivation: Over the last decades several glycomics-based bioinformatics resources and databases have been created and released to the public. Unfortunately, there is no common standard in the representation of the stored information or a common machine-readable interface allowing bioinformatics groups to easily extract and cross-reference the stored information. Results: An international group of bioinformatics experts in the field of glycomics have worked together to create a standard Resource Description Framework (RDF) representation for glycomics data, focused on glycan sequences and related biological source, publications and experimental data. This RDF standard is defined by the GlycoRDF ontology and will be used by database providers to generate common machine-readable exports of the data stored in their databases. Availability and implementation: The ontology, supporting documentation and source code used by database providers to generate standardized RDF are available online (http://www.glycoinfo.org/GlycoRDF/). Contact: rene@ccrc.uga.edu or kkiyoko@soka.ac.jp Supplementary information: Supplementary data are available at Bioinformatics online. PMID:25388145

GlycoRDF: an ontology to standardize glycomics data in RDF.

PubMed

Ranzinger, Rene; Aoki-Kinoshita, Kiyoko F; Campbell, Matthew P; Kawano, Shin; Lütteke, Thomas; Okuda, Shujiro; Shinmachi, Daisuke; Shikanai, Toshihide; Sawaki, Hiromichi; Toukach, Philip; Matsubara, Masaaki; Yamada, Issaku; Narimatsu, Hisashi

2015-03-15

Over the last decades several glycomics-based bioinformatics resources and databases have been created and released to the public. Unfortunately, there is no common standard in the representation of the stored information or a common machine-readable interface allowing bioinformatics groups to easily extract and cross-reference the stored information. An international group of bioinformatics experts in the field of glycomics have worked together to create a standard Resource Description Framework (RDF) representation for glycomics data, focused on glycan sequences and related biological source, publications and experimental data. This RDF standard is defined by the GlycoRDF ontology and will be used by database providers to generate common machine-readable exports of the data stored in their databases. The ontology, supporting documentation and source code used by database providers to generate standardized RDF are available online (http://www.glycoinfo.org/GlycoRDF/). © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Biological Soil Crust Technical Reference

Science.gov Websites

Technical Reference Our understanding of the biology, ecology and physiology of biological soil crusts has published studies on soil crusts. The attached PDF file is a 90-page report that summarizes our current state of knowledge about biological soil crusts, with emphasis on crusts found in the western United

Stabilized-solubilized ferric pyrophosphate as a new iron source for food fortification. Bioavailability studies by means of the prophylactic-preventive method in rats.

PubMed

Salgueiro, M J; Arnoldi, S; Kaliski, M A; Torti, H; Messeri, E; Weill, R; Zubillaga, M; Boccio, J

2009-02-01

The purpose of the present work was to evaluate the iron bioavailability of a new ferric pyrophosphate salt stabilized and solubilized with glycine. The prophylactic-preventive test in rats, using ferrous sulfate as the reference standard, was applied as the evaluating methodology both using water and yogurt as vehicles. Fifty female Sprague-Dawley rats weaned were randomized into five different groups (group 1: FeSO(4); group 2: pyr; group 3: FeSO(4) + yogurt; group 4: pyr + yogurt and group 5: control). The iron bioavailability (BioFe) of each compound was calculated using the formula proposed by Dutra-de-Oliveira et al. where BioFe % = (HbFef - HbFei) x 100/ToFeIn. Finally, the iron bioavailability results of each iron source were also given as relative biological value (RBV) using ferrous sulfate as the reference standard. The results showed that both BioFe % and RBV % of the new iron source tested is similar to that of the reference standard independently of the vehicle employed for the fortification procedure (FeSO(4) 49.46 +/- 12.0% and 100%; Pyr 52.66 +/- 15.02% and 106%; FeSO(4) + yogurth 54.39 +/- 13.92% and 110%; Pyr + yogurt 61.97 +/- 13.54% and 125%; Control 25.30 +/- 6.60, p < 0.05). Therefore, the stabilized and soluble ferric pyrophosphate may be considered as an optimal iron source for food fortification.

Challenges in the indirect quantitation of acyl-glucuronide metabolites of a cardiovascular drug from complex biological mixtures in the absence of reference standards.

PubMed

Srinivasan, Karthik; Nouri, Parya; Kavetskaia, Olga

2010-07-01

This paper describes the quantitation of acyl-glucuronide metabolites (M26 and M5) of a cardiovascular-drug (torcetrapib) from monkey urine, in the absence of their reference standards. LC/MS/MS assays for M1 and M4 (aglycones of M26 and M5, respectively) were characterized from normal and base-treated urine, as their respective reference standards were available. The in vivo study samples containing M26 and M5 were treated with 1 n sodium hydroxide to hydrolyze them to their respective aglycones. The study samples were assayed for M1 and M4 before and after alkaline hydrolysis and the difference in the concentrations provided an estimate of the urinary levels of M26 and M5. Prior to the main sample analysis, conditions for alkaline hydrolysis of the glucuronides were optimized by incubating pooled study samples. During incubations, a prolonged increase in M4 levels over time was observed, which is inconsistent with the base-hydrolysis of an acyl-glucuronide (expected to hydrolyze rapidly). Possible interference of the metabolite M9 (an ether-glucuronide metabolite isobaric to M4) was investigated to explain this observation using chromatographic and wet-chemistry approaches. The strategies adopted herein established that the LC/MS/MS assay and our approach were reliable. The metabolite exposure was then correlated to toxicological observations to gain initial insights into the physiological role of these metabolites. Copyright (c) 2009 John Wiley & Sons, Ltd.

Multicenter Evaluation of Cystatin C Measurement after Assay Standardization.

PubMed

Bargnoux, Anne-Sophie; Piéroni, Laurence; Cristol, Jean-Paul; Kuster, Nils; Delanaye, Pierre; Carlier, Marie-Christine; Fellahi, Soraya; Boutten, Anne; Lombard, Christine; González-Antuña, Ana; Delatour, Vincent; Cavalier, Etienne

2017-04-01

Since 2010, a certified reference material ERM-DA471/IFCC has been available for cystatin C (CysC). This study aimed to assess the sources of uncertainty in results for clinical samples measured using standardized assays. This evaluation was performed in 2015 and involved 7 clinical laboratories located in France and Belgium. CysC was measured in a panel of 4 serum pools using 8 automated assays and a candidate isotope dilution mass spectrometry reference measurement procedure. Sources of uncertainty (imprecision and bias) were evaluated to calculate the relative expanded combined uncertainty for each CysC assay. Uncertainty was judged against the performance specifications derived from the biological variation model. Only Siemens reagents on the Siemens systems and, to a lesser extent, DiaSys reagents on the Cobas system, provided results that met the minimum performance criterion calculated according to the intraindividual and interindividual biological variations. Although the imprecision was acceptable for almost all assays, an increase in the bias with concentration was observed for Gentian reagents, and unacceptably high biases were observed for Abbott and Roche reagents on their own systems. This comprehensive picture of the market situation since the release of ERM-DA471/IFCC shows that bias remains the major component of the combined uncertainty because of possible problems associated with the implementation of traceability. Although some manufacturers have clearly improved their calibration protocols relative to ERM-DA471, most of them failed to meet the criteria for acceptable CysC measurements. © 2016 American Association for Clinical Chemistry.

Effect of Transitioning from Standard Reference Material 2806a to Standard Reference Material 2806b for Light Obscuration Particle Countering

DTIC Science & Technology

2016-04-01

Reference Material 2806b for Light Obscuration Particle Countering April 2016 UNCLASSIFIED UNCLASSIFIED Joel Schmitigal 27809 Standard Form 298 (Rev...Standard Reference Material 2806b for Light Obscuration Particle Countering 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6...Reference Material 2806a to Standard Reference Material 2806b for Light Obscuration Particle Countering Joel Schmitigal Force Projection

Synthetic Peptide Arrays for Pathway-Level Protein Monitoring by Liquid Chromatography-Tandem Mass Spectrometry*

PubMed Central

Hewel, Johannes A.; Liu, Jian; Onishi, Kento; Fong, Vincent; Chandran, Shamanta; Olsen, Jonathan B.; Pogoutse, Oxana; Schutkowski, Mike; Wenschuh, Holger; Winkler, Dirk F. H.; Eckler, Larry; Zandstra, Peter W.; Emili, Andrew

2010-01-01

Effective methods to detect and quantify functionally linked regulatory proteins in complex biological samples are essential for investigating mammalian signaling pathways. Traditional immunoassays depend on proprietary reagents that are difficult to generate and multiplex, whereas global proteomic profiling can be tedious and can miss low abundance proteins. Here, we report a target-driven liquid chromatography-tandem mass spectrometry (LC-MS/MS) strategy for selectively examining the levels of multiple low abundance components of signaling pathways which are refractory to standard shotgun screening procedures and hence appear limited in current MS/MS repositories. Our stepwise approach consists of: (i) synthesizing microscale peptide arrays, including heavy isotope-labeled internal standards, for use as high quality references to (ii) build empirically validated high density LC-MS/MS detection assays with a retention time scheduling system that can be used to (iii) identify and quantify endogenous low abundance protein targets in complex biological mixtures with high accuracy by correlation to a spectral database using new software tools. The method offers a flexible, rapid, and cost-effective means for routine proteomic exploration of biological systems including “label-free” quantification, while minimizing spurious interferences. As proof-of-concept, we have examined the abundance of transcription factors and protein kinases mediating pluripotency and self-renewal in embryonic stem cell populations. PMID:20467045

THE CONCEPT OF REFERENCE CONDITION, REVISITED ...

EPA Pesticide Factsheets

Ecological assessments of aquatic ecosystems depend on the ability to compare current conditions against some expectation of how they could be in the absence of significant human disturbance. The concept of a ‘‘reference condition’’ is often used to describe the standard or benchmark against which current condition is compared. If assessments are to be conducted consistently, then a common understanding of the definitions and complications of reference condition is necessary. A 2006 paper (Stoddard et al., 2006, Ecological Applications 16:1267-1276) made an early attempt at codifying the reference condition concept; in this presentation we will revisit the points raised in that paper (and others) and examine how our thinking has changed in a little over 10 years.Among the issues to be discussed: (1) the “moving target” created when reference site data are used to set thresholds in large scale assessments; (2) natural vs. human disturbance and their effects on reference site distributions; (3) circularity and the use of biological data to assist in reference site identification; (4) using site-scale (in-stream or in-lake) measurements vs. landscape-level human activity to identify reference conditions. Ecological assessments of aquatic ecosystems depend on the ability to compare current conditions against some expectation of how they could be in the absence of significant human disturbance. The concept of a ‘‘reference condition’’ is often use

Multicentre evaluation of stable reference whole blood for enumeration of lymphocyte subsets by flow cytometry.

PubMed

Edwards, Cherry; Belgrave, Danielle; Janossy, George; Bradley, Nicholas J; Stebbings, Richard; Gaines-Das, Rose; Thorpe, Robin; Sawle, Alex; Arroz, Maria Jorge; Brando, Bruno; Gratama, Jan Willem; Orfao de Matos, Alberto; Papa, Stephano; Papamichail, Michael; Lenkei, Rodica; Rothe, Gregor; Barnett, David

2005-06-22

BACKGROUND: Clinical indications for lymphocyte subset enumeration by flow cytometry include monitoring of disease progression and timing of therapeutic intervention in infection with human immunodeficiency virus. Until recently international standardisation has not been possible due to a lack of suitable stable reference material. METHODS: This study consisted of two trials of a stabilised whole blood preparation. Eleven participants were sent two standard protocols for staining plus gating strategy and asked to report absolute counts for lymphocyte subsets. RESULTS: No significant difference was detected between the two methods when results from the two assays and all partners were pooled. Significant differences in results from the different partners were observed. However, representative mean counts were obtained for geometric means, geometric coefficient of variation, and 95% confidence interval for CD3 910 cells/mul, 9%, and 888 to 933, respectively), CD4 (495 cells/mul, 12%, and 483 to 507), and CD8 (408 cells/mul, 13%, and 393 to 422). CONCLUSION: We have introduced a stabilised blood preparation and a well-characterized biological standard. The availability of this reference material greatly simplifies the validation of new techniques for CD4(+) T-cell enumeration and the expansion of external quality assurance programmes for clinical laboratories, including those that operate in resource-restricted environments. (c) 2005 Wiley-Liss, Inc.

Striking against bioterrorism with advanced proteomics and reference methods.

PubMed

Armengaud, Jean

2017-01-01

The intentional use by terrorists of biological toxins as weapons has been of great concern for many years. Among the numerous toxins produced by plants, animals, algae, fungi, and bacteria, ricin is one of the most scrutinized by the media because it has already been used in biocrimes and acts of bioterrorism. Improving the analytical toolbox of national authorities to monitor these potential bioweapons all at once is of the utmost interest. MS/MS allows their absolute quantitation and exhibits advantageous sensitivity, discriminative power, multiplexing possibilities, and speed. In this issue of Proteomics, Gilquin et al. (Proteomics 2017, 17, 1600357) present a robust multiplex assay to quantify a set of eight toxins in the presence of a complex food matrix. This MS/MS reference method is based on scheduled SRM and high-quality standards consisting of isotopically labeled versions of these toxins. Their results demonstrate robust reliability based on rather loose scheduling of SRM transitions and good sensitivity for the eight toxins, lower than their oral median lethal doses. In the face of an increased threat from terrorism, relevant reference assays based on advanced proteomics and high-quality companion toxin standards are reliable and firm answers. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Introducing AAA-MS, a rapid and sensitive method for amino acid analysis using isotope dilution and high-resolution mass spectrometry.

PubMed

Louwagie, Mathilde; Kieffer-Jaquinod, Sylvie; Dupierris, Véronique; Couté, Yohann; Bruley, Christophe; Garin, Jérôme; Dupuis, Alain; Jaquinod, Michel; Brun, Virginie

2012-07-06

Accurate quantification of pure peptides and proteins is essential for biotechnology, clinical chemistry, proteomics, and systems biology. The reference method to quantify peptides and proteins is amino acid analysis (AAA). This consists of an acidic hydrolysis followed by chromatographic separation and spectrophotometric detection of amino acids. Although widely used, this method displays some limitations, in particular the need for large amounts of starting material. Driven by the need to quantify isotope-dilution standards used for absolute quantitative proteomics, particularly stable isotope-labeled (SIL) peptides and PSAQ proteins, we developed a new AAA assay (AAA-MS). This method requires neither derivatization nor chromatographic separation of amino acids. It is based on rapid microwave-assisted acidic hydrolysis followed by high-resolution mass spectrometry analysis of amino acids. Quantification is performed by comparing MS signals from labeled amino acids (SIL peptide- and PSAQ-derived) with those of unlabeled amino acids originating from co-hydrolyzed NIST standard reference materials. For both SIL peptides and PSAQ standards, AAA-MS quantification results were consistent with classical AAA measurements. Compared to AAA assay, AAA-MS was much faster and was 100-fold more sensitive for peptide and protein quantification. Finally, thanks to the development of a labeled protein standard, we also extended AAA-MS analysis to the quantification of unlabeled proteins.

Longitudinal meta-analysis of NIST pH Standard Reference Materials(®): a complement to pH key comparisons.

PubMed

Pratt, Kenneth W

2015-04-01

This meta-analysis assesses the long-term (up to 70 years) within-laboratory variation of the NIST pH Standard Reference Material® (SRM) tetroxalate, phthalate, phosphate, borate, and carbonate buffers. Values of ΔpH(S), the difference between the certified pH value, pH(S), of each SRM issue and the mean of all pH(S) values for the given SRM at that Celsius temperature, t, are graphed as a function of the SRM issue and t. In most cases, |ΔpH(S)| < 0.004. Deviations from the nominal base:acid amount (mole) ratio of a buffer yield t-independent, constant shifts in ΔpH(S). The mean ΔpH(S) characterizes such deviations. The corresponding mole fraction of impurity in the conjugate buffer component is generally <0.3 %. Changes in the equipment, personnel, materials, and methodology of the pH(S) measurement yield t-dependent variations. The standard deviation of ΔpH(S) characterizes such changes. Standard deviations of ΔpH(S) are generally 0.0015 or less. The results provide a long-term, single-institution complement to the time-specific, multi-institution results of pH key comparisons administered by the Consultative Committee for Metrology in Chemistry and Biology (CCQM).

Quantifying biological integrity by taxonomic completeness: its utility in regional and global assessments.

PubMed

Hawkins, Charles P

2006-08-01

Water resources managers and conservation biologists need reliable, quantitative, and directly comparable methods for assessing the biological integrity of the world's aquatic ecosystems. Large-scale assessments are constrained by the lack of consistency in the indicators used to assess biological integrity and our current inability to translate between indicators. In theory, assessments based on estimates of taxonomic completeness, i.e., the proportion of expected taxa that were observed (observed/expected, O/E) are directly comparable to one another and should therefore allow regionally and globally consistent summaries of the biological integrity of freshwater ecosystems. However, we know little about the true comparability of O/E assessments derived from different data sets or how well O/E assessments perform relative to other indicators in use. I compared the performance (precision, bias, and sensitivity to stressors) of O/E assessments based on five different data sets with the performance of the indicators previously applied to these data (three multimetric indices, a biotic index, and a hybrid method used by the state of Maine). Analyses were based on data collected from U.S. stream ecosystems in North Carolina, the Mid-Atlantic Highlands, Maine, and Ohio. O/E assessments resulted in very similar estimates of mean regional conditions compared with most other indicators once these indicators' values were standardized relative to reference-site means. However, other indicators tended to be biased estimators of O/E, a consequence of differences in their response to natural environmental gradients and sensitivity to stressors. These results imply that, in some cases, it may be possible to compare assessments derived from different indicators by standardizing their values (a statistical approach to data harmonization). In situations where it is difficult to standardize or otherwise harmonize two or more indicators, O/E values can easily be derived from existing raw sample data. With some caveats, O/E should provide more directly comparable assessments of biological integrity across regions than is possible by harmonizing values of a mix of indicators.

The Technical and Biological Reproducibility of Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS) Based Typing: Employment of Bioinformatics in a Multicenter Study.

PubMed

Oberle, Michael; Wohlwend, Nadia; Jonas, Daniel; Maurer, Florian P; Jost, Geraldine; Tschudin-Sutter, Sarah; Vranckx, Katleen; Egli, Adrian

2016-01-01

The technical, biological, and inter-center reproducibility of matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI TOF MS) typing data has not yet been explored. The aim of this study is to compare typing data from multiple centers employing bioinformatics using bacterial strains from two past outbreaks and non-related strains. Participants received twelve extended spectrum betalactamase-producing E. coli isolates and followed the same standard operating procedure (SOP) including a full-protein extraction protocol. All laboratories provided visually read spectra via flexAnalysis (Bruker, Germany). Raw data from each laboratory allowed calculating the technical and biological reproducibility between centers using BioNumerics (Applied Maths NV, Belgium). Technical and biological reproducibility ranged between 96.8-99.4% and 47.6-94.4%, respectively. The inter-center reproducibility showed a comparable clustering among identical isolates. Principal component analysis indicated a higher tendency to cluster within the same center. Therefore, we used a discriminant analysis, which completely separated the clusters. Next, we defined a reference center and performed a statistical analysis to identify specific peaks to identify the outbreak clusters. Finally, we used a classifier algorithm and a linear support vector machine on the determined peaks as classifier. A validation showed that within the set of the reference center, the identification of the cluster was 100% correct with a large contrast between the score with the correct cluster and the next best scoring cluster. Based on the sufficient technical and biological reproducibility of MALDI-TOF MS based spectra, detection of specific clusters is possible from spectra obtained from different centers. However, we believe that a shared SOP and a bioinformatics approach are required to make the analysis robust and reliable.

TU-EF-304-09: Quantifying the Biological Effects of Therapeutic Protons by LET Spectrum Analysis

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

Guan, F; Bronk, L; Kerr, M

2015-06-15

Purpose: To correlate in vitro cell kill with linear energy transfer (LET) spectra using Monte Carlo simulations and knowledge obtained from previous high-throughput in vitro proton relative biological effectiveness (RBE) measurements. Methods: The Monte Carlo simulation toolkit Geant4 was used to design the experimental setups and perform the dose, dose-averaged LET, and LET spectra calculations. The clonogenic assay was performed using the H460 lung cancer cell line in standard 6-well plates. Using two different experimental setups, the same dose and dose-averaged LET (12.6 keV/µm) was delivered to the cell layer; however, each respective energy or LET spectrum was different. Wemore » quantified the dose contributions from high-LET (≥10 keV/µm, threshold determined by previous RBE measurements) events in the LET spectra separately for these two setups as 39% and 53%. 8 dose levels with 1 Gy increments were delivered. The photon reference irradiation was performed using 6 MV x-rays from a LINAC. Results: The survival curves showed that both proton irradiations demonstrated an increased RBE compared to the reference photon irradiation. Within the proton-irradiated cells, the setup with 53% dose contribution from high-LET events exhibited the higher biological effectiveness. Conclusion: The experimental results indicate that the dose-averaged LET may not be an appropriate indicator to quantify the biological effects of protons when the LET spectrum is broad enough to contain both low- and high-LET events. Incorporating the LET spectrum distribution into robust intensity-modulated proton therapy optimization planning may provide more accurate biological dose distribution than using the dose-averaged LET. NIH Program Project Grant 2U19CA021239-35.« less

Evolutionary Design in Biological Physics and Materials Science

NASA Astrophysics Data System (ADS)

Yang, M.; Park, J.-M.; Deem, M. W.

In this chapter we provide a thorough discussion of the theoretical description of the multi-site approach to cancer vaccination. The discussion is somewhat demanding from a biological point of view. References to primary biological publications are given. A general reference on immunology is [1].

Impact of a product-specific reference standard for the measurement of a PEGylated rFVIII activity: the Swiss Multicentre Field Study.

PubMed

Bulla, O; Poncet, A; Alberio, L; Asmis, L M; Gähler, A; Graf, L; Nagler, M; Studt, J-D; Tsakiris, D A; Fontana, P

2017-07-01

Measuring factor VIII (FVIII) activity can be challenging when it has been modified, such as when FVIII is pegylated to increase its circulating half-life. Use of a product-specific reference standard may help avoid this issue. Evaluate the impact of using a product-specific reference standard for measuring the FVIII activity of BAX 855 - a pegylated FVIII - in eight of Switzerland's main laboratories. Factor VIII-deficient plasma, spiked with five different concentrations of BAX 855, plus a control FVIII sample, was sent to the participating laboratories. They measured FVIII activity by using either with a one-stage (OSA) or the chromogenic assay (CA) against their local or a product-specific reference standard. When using a local reference standard, there was an overestimation of BAX 855 activity compared to the target concentrations, both with the OSA and CA. The use of a product-specific reference standard reduced this effect: mean recovery ranged from 127.7% to 213.5% using the OSA with local reference standards, compared to 110% to 183.8% with a product-specific reference standard, and from 146.3% to 182.4% using the CA with local reference standards compared to 72.7% to 103.7% with a product-specific reference standard. In this in vitro study, the type of reference standard had a major impact on the measurement of BAX 855 activity. Evaluation was more accurate and precise when using a product-specific reference standard. © 2017 John Wiley & Sons Ltd.

The theory of reference values: an unfinished symphony.

PubMed

Siest, Gerard; Henny, Joseph; Gräsbeck, Ralph; Wilding, Peter; Petitclerc, Claude; Queraltó, Josep M; Hyltoft Petersen, Peter

2013-01-01

The history of the theory of reference values can be written as an unfinished symphony. The first movement, allegro con fuoco, played from 1960 to 1980: a mix of themes devoted to the study of biological variability (intra-, inter-individual, short- and long-term), preanalytical conditions, standardization of analytical methods, quality control, statistical tools for deriving reference limits, all of them complex variations developed on a central melody: the new concept of reference values that would replace the notion of normality whose definition was unclear. Additional contributions (multivariate reference values, use of reference limits from broad sets of patient data, drug interferences) conclude the movement on the variability of laboratory tests. The second movement, adagio, from 1980 to 2000, slowly develops and implements initial works. International and national recommendations were published by the IFCC-LM (International Federation of Clinical Chemistry and Laboratory Medicine) and scientific societies [French (SFBC), Spanish (SEQC), Scandinavian societies…]. Reference values are now topics of many textbooks and of several congresses, workshops, and round tables that are organized all over the world. Nowadays, reference values are part of current practice in all clinical laboratories, but not without difficulties, particularly for some laboratories to produce their own reference values and the unsuitability of the concept with respect to new technologies such as HPLC, GCMS, and PCR assays. Clinicians through consensus groups and practice guidelines have introduced their own tools, the decision limits, likelihood ratios and Reference Change Value (RCV), creating confusion among laboratorians and clinicians in substituting reference values and decision limits in laboratory reports. The rapid development of personalized medicine will eventually call for the use of individual reference values. The beginning of the second millennium is played allegro ma non-troppo from 2000 to 2012: the theory of reference values is back into fashion. The need to revise the concept is emerging. The manufacturers make a friendly pressure to facilitate the integration of Reference Intervals (RIs) in their technical documentation. Laboratorians are anxiously awaiting the solutions for what to do. The IFCC-LM creates Reference Intervals and Decision Limits Committee (C-RIDL) in 2005. Simultaneously, a joint working group IFCC-CLSI is created on the same topic. In 2008 the initial recommendations of IFCC-LM are revised and new guidelines are published by the Clinical and Laboratory Standards Institute (CLSI C28-A3). Fundamentals of the theory of reference values are not changed, but new avenues are explored: RIs transference, multicenter reference intervals, and a robust method for deriving RIs from small number of subjects. Concomitantly, other statistical methods are published such as bootstraps calculation and partitioning procedures. An alternative to recruiting healthy subjects proposes the use of biobanks conditional to the availability of controlled preanalytical conditions and of bioclinical data. The scope is also widening to include veterinary biology! During the early 2000s, several groups proposed the concept of 'Universal RIs' or 'Global RIs'. Still controversial, their applications await further investigations. The fourth movement, finale: beyond the methodological issues (statistical and analytical essentially), important questions remain unanswered. Do RIs intervene appropriately in medical decision-making? Are RIs really useful to the clinicians? Are evidence-based decision limits more appropriate? It should be appreciated that many laboratory tests represent a continuum that weakens the relevance of RIs. In addition, the boundaries between healthy and pathological states are shady areas influenced by many biological factors. In such a case the use of a single threshold is questionable. Wherever it will apply, individual reference values and reference change values have their place. A variation on an old theme! It is strange that in the period of personalized medicine (that is more stratified medicine), the concept of reference values which is based on stratification of homogeneous subgroups of healthy people could not be discussed and developed in conjunction with the stratification of sick patients. That is our message for the celebration of the 50th anniversary of Clinical Chemistry and Laboratory Medicine. Prospects are broad, enthusiasm is not lacking: much remains to be done, good luck for the new generations!

Long-Term Impacts on Macroinvertebrates Downstream of Reclaimed Mountaintop Mining Valley Fills in Central Appalachia

NASA Astrophysics Data System (ADS)

Pond, Gregory J.; Passmore, Margaret E.; Pointon, Nancy D.; Felbinger, John K.; Walker, Craig A.; Krock, Kelly J. G.; Fulton, Jennifer B.; Nash, Whitney L.

2014-10-01

Recent studies have documented adverse effects to biological communities downstream of mountaintop coal mining and valley fills (VF), but few data exist on the longevity of these impacts. We sampled 15 headwater streams with VFs reclaimed 11-33 years prior to 2011 and sampled seven local reference sites that had no VFs. We collected chemical, habitat, and benthic macroinvertebrate data in April 2011; additional chemical samples were collected in September 2011. To assess ecological condition, we compared VF and reference abiotic and biotic data using: (1) ordination to detect multivariate differences, (2) benthic indices (a multimetric index and an observed/expected predictive model) calibrated to state reference conditions to detect impairment, and (3) correlation and regression analysis to detect relationships between biotic and abiotic data. Although VF sites had good instream habitat, nearly 90 % of these streams exhibited biological impairment. VF sites with higher index scores were co-located near unaffected tributaries; we suggest that these tributaries were sources of sensitive taxa as drifting colonists. There were clear losses of expected taxa across most VF sites and two functional feeding groups (% scrapers and %shredders) were significantly altered. Percent VF and forested area were related to biological quality but varied more than individual ions and specific conductance. Within the subset of VF sites, other descriptors (e.g., VF age, site distance from VF, the presence of impoundments, % forest) had no detectable relationships with biological condition. Although these VFs were constructed pursuant to permits and regulatory programs that have as their stated goals that (1) mined land be reclaimed and restored to its original use or a use of higher value, and (2) mining does not cause or contribute to violations of water quality standards, we found sustained ecological damage in headwaters streams draining VFs long after reclamation was completed.

Optimization of Sample Preparation for the Identification and Quantification of Saxitoxin in Proficiency Test Mussel Sample using Liquid Chromatography-Tandem Mass Spectrometry

PubMed Central

Harju, Kirsi; Rapinoja, Marja-Leena; Avondet, Marc-André; Arnold, Werner; Schär, Martin; Burrell, Stephen; Luginbühl, Werner; Vanninen, Paula

2015-01-01

Saxitoxin (STX) and some selected paralytic shellfish poisoning (PSP) analogues in mussel samples were identified and quantified with liquid chromatography-tandem mass spectrometry (LC-MS/MS). Sample extraction and purification methods of mussel sample were optimized for LC-MS/MS analysis. The developed method was applied to the analysis of the homogenized mussel samples in the proficiency test (PT) within the EQuATox project (Establishment of Quality Assurance for the Detection of Biological Toxins of Potential Bioterrorism Risk). Ten laboratories from eight countries participated in the STX PT. Identification of PSP toxins in naturally contaminated mussel samples was performed by comparison of product ion spectra and retention times with those of reference standards. The quantitative results were obtained with LC-MS/MS by spiking reference standards in toxic mussel extracts. The results were within the z-score of ±1 when compared to the results measured with the official AOAC (Association of Official Analytical Chemists) method 2005.06, pre-column oxidation high-performance liquid chromatography with fluorescence detection (HPLC-FLD). PMID:26610567

Experimental verification of stopping-power prediction from single- and dual-energy computed tomography in biological tissues

NASA Astrophysics Data System (ADS)

Möhler, Christian; Russ, Tom; Wohlfahrt, Patrick; Elter, Alina; Runz, Armin; Richter, Christian; Greilich, Steffen

2018-01-01

An experimental setup for consecutive measurement of ion and x-ray absorption in tissue or other materials is introduced. With this setup using a 3D-printed sample container, the reference stopping-power ratio (SPR) of materials can be measured with an uncertainty of below 0.1%. A total of 65 porcine and bovine tissue samples were prepared for measurement, comprising five samples each of 13 tissue types representing about 80% of the total body mass (three different muscle and fatty tissues, liver, kidney, brain, heart, blood, lung and bone). Using a standard stoichiometric calibration for single-energy CT (SECT) as well as a state-of-the-art dual-energy CT (DECT) approach, SPR was predicted for all tissues and then compared to the measured reference. With the SECT approach, the SPRs of all tissues were predicted with a mean error of (-0.84  ±  0.12)% and a mean absolute error of (1.27  ±  0.12)%. In contrast, the DECT-based SPR predictions were overall consistent with the measured reference with a mean error of (-0.02  ±  0.15)% and a mean absolute error of (0.10  ±  0.15)%. Thus, in this study, the potential of DECT to decrease range uncertainty could be confirmed in biological tissue.

HPMCD: the database of human microbial communities from metagenomic datasets and microbial reference genomes.

PubMed

Forster, Samuel C; Browne, Hilary P; Kumar, Nitin; Hunt, Martin; Denise, Hubert; Mitchell, Alex; Finn, Robert D; Lawley, Trevor D

2016-01-04

The Human Pan-Microbe Communities (HPMC) database (http://www.hpmcd.org/) provides a manually curated, searchable, metagenomic resource to facilitate investigation of human gastrointestinal microbiota. Over the past decade, the application of metagenome sequencing to elucidate the microbial composition and functional capacity present in the human microbiome has revolutionized many concepts in our basic biology. When sufficient high quality reference genomes are available, whole genome metagenomic sequencing can provide direct biological insights and high-resolution classification. The HPMC database provides species level, standardized phylogenetic classification of over 1800 human gastrointestinal metagenomic samples. This is achieved by combining a manually curated list of bacterial genomes from human faecal samples with over 21000 additional reference genomes representing bacteria, viruses, archaea and fungi with manually curated species classification and enhanced sample metadata annotation. A user-friendly, web-based interface provides the ability to search for (i) microbial groups associated with health or disease state, (ii) health or disease states and community structure associated with a microbial group, (iii) the enrichment of a microbial gene or sequence and (iv) enrichment of a functional annotation. The HPMC database enables detailed analysis of human microbial communities and supports research from basic microbiology and immunology to therapeutic development in human health and disease. © The Author(s) 2015. Published by Oxford University Press on behalf of Nucleic Acids Research.

The Renilla luciferase gene as a reference gene for normalization of gene expression in transiently transfected cells.

PubMed

Jiwaji, Meesbah; Daly, Rónán; Pansare, Kshama; McLean, Pauline; Yang, Jingli; Kolch, Walter; Pitt, Andrew R

2010-12-31

The importance of appropriate normalization controls in quantitative real-time polymerase chain reaction (qPCR) experiments has become more apparent as the number of biological studies using this methodology has increased. In developing a system to study gene expression from transiently transfected plasmids, it became clear that normalization using chromosomally encoded genes is not ideal, at it does not take into account the transfection efficiency and the significantly lower expression levels of the plasmids. We have developed and validated a normalization method for qPCR using a co-transfected plasmid. The best chromosomal gene for normalization in the presence of the transcriptional activators used in this study, cadmium, dexamethasone, forskolin and phorbol-12-myristate 13-acetate was first identified. qPCR data was analyzed using geNorm, Normfinder and BestKeeper. Each software application was found to rank the normalization controls differently with no clear correlation. Including a co-transfected plasmid encoding the Renilla luciferase gene (Rluc) in this analysis showed that its calculated stability was not as good as the optimised chromosomal genes, most likely as a result of the lower expression levels and transfection variability. Finally, we validated these analyses by testing two chromosomal genes (B2M and ActB) and a co-transfected gene (Rluc) under biological conditions. When analyzing co-transfected plasmids, Rluc normalization gave the smallest errors compared to the chromosomal reference genes. Our data demonstrates that transfected Rluc is the most appropriate normalization reference gene for transient transfection qPCR analysis; it significantly reduces the standard deviation within biological experiments as it takes into account the transfection efficiencies and has easily controllable expression levels. This improves reproducibility, data validity and most importantly, enables accurate interpretation of qPCR data.

European Pharmacopoeia biological reference preparation for poliomyelitis vaccine (inactivated): collaborative study for the establishment of batch No. 3.

PubMed

Martin, J; Daas, A; Milne, C

2016-01-01

Inactivated poliomyelitis vaccines are an important part of the World Health Organization (WHO) control strategy to eradicate poliomyelitis. Requirements for the quality control of poliomyelitis vaccines (inactivated) include the use of an in vitro D antigen quantification assay for potency determination on the final lot as outlined in the European Pharmacopoeia (Ph. Eur.) monograph 0214. Performance of this assay requires a reference preparation calibrated in International Units (IU). A Ph. Eur. biological reference preparation (BRP) for poliomyelitis vaccine (inactivated) calibrated in IU has been established for this purpose. Due to the dwindling stocks of batch 2 of the BRP a collaborative study was run as part of the European Directorate for the Quality of Medicines & HealthCare (EDQM) Biological Standardisation Programme to establish BRP batch 3 (BRP3). Twelve laboratories including Official Medicines Control Laboratories (OMCLs) and manufacturers participated. The candidate BRP3 (cBRP3) was from the same source and had the same characteristics as BRP batch 2 (BRP2). During the study the candidate was calibrated against the 3 rd International Standard for inactivated poliomyelitis vaccine using in-house D antigen ELISA assays in line with the Ph. Eur. monograph 0214. The candidate was also compared to BRP2 to evaluate the continuity. Based on the results of the study, values of 320 DU/mL, 78 DU/mL and 288 DU/mL (D antigen units/mL) (IU) for poliovirus type 1, 2 and 3 respectively were assigned to the candidate. In June 2016, the Ph. Eur. Commission adopted the material as Ph. Eur. BRP for poliomyelitis vaccine (inactivated) batch 3.

Assessment of reference gene stability in Rice stripe virus and Rice black streaked dwarf virus infection rice by quantitative Real-time PCR.

PubMed

Fang, Peng; Lu, Rongfei; Sun, Feng; Lan, Ying; Shen, Wenbiao; Du, Linlin; Zhou, Yijun; Zhou, Tong

2015-10-24

Stably expressed reference gene(s) normalization is important for the understanding of gene expression patterns by quantitative Real-time PCR (RT-qPCR), particularly for Rice stripe virus (RSV) and Rice black streaked dwarf virus (RBSDV) that caused seriously damage on rice plants in China and Southeast Asia. The expression of fourteen common used reference genes of Oryza sativa L. were evaluated by RT-qPCR in RSV and RBSDV infected rice plants. Suitable normalization reference gene(s) were identified by geNorm and NormFinder algorithms. UBQ 10 + GAPDH and UBC + Actin1 were identified as suitable reference genes for RT-qPCR normalization under RSV and RBSDV infection, respectively. When using multiple reference genes, the expression patterns of OsPRIb and OsWRKY, two virus resistance genes, were approximately similar with that reported previously. Comparatively, by using single reference gene (TIP41-Like), a weaker inducible response was observed. We proposed that the combination of two reference genes could obtain more accurate and reliable normalization of RT-qPCR results in RSV- and RBSDV-infected plants. This work therefore sheds light on establishing a standardized RT-qPCR procedure in RSV- and RBSDV-infected rice plants, and might serve as an important point for discovering complex regulatory networks and identifying genes relevant to biological processes or implicated in virus.

Regional reference variation provides ecologically meaningful protection criteria for northern world heritage site.

PubMed

Bowman, Michelle; Spencer, Paula; Dubé, Monique; West, David

2010-01-01

Unprecedented rates of resource development and climate change at northern latitudes coupled with a lack of baseline information limits our ability to set ecologically meaningful criteria needed to protect these inherently sensitive ecosystems. We surveyed water and sediment chemistry, community composition of benthic algae and invertebrates and fish, and condition of a sentinel fish species, slimy sculpin (Cottus cognatus), in 2 rivers adjacent to metal mines and in 20 reference rivers in the headwaters of a World Heritage Site, the South Nahanni River Basin, NWT, Canada. The normal range (i.e., mean ± 2 standard deviations) of biological conditions in regional reference sites (grouped by community type) were used to set ecologically meaningful effect sizes. These effect sizes were used in noncentral hypotheses tests to assess the ecological condition of potentially impaired sites. Significant impairments at sites influenced by current and historical mining activity were indicative of mild enrichment (e.g., increased benthic abundance and sculpin condition) and bioaccumulation of metals (e.g., increased concentrations of Cu and Fe in muscle tissue of sculpin). Comparisons between our regional reference study and a concurrent upstream–downstream study showed that the sensitivity of biological endpoints was typically related to the impairment criteria used and not to the type of study design. Concentrations of metals such as Al, Cu, and Fe in river water at reference sites were above federal and regional guidelines, suggesting that these guidelines are not appropriate for the metal-rich headwaters of the South Nahanni River. The ephemerellid mayflies Drunella spinifera and Ephemerella maculata were present in 4 of our study sites; their occurrence had not previously been documented in the Yukon or Northwest Territories. Our results confirmed that the lack of baseline information on the physiochemical and biological composition of northern rivers is hampering our ability to evaluate changes in these understudied ecosystems. However, the use of noncentral hypotheses tests based on empirically derived effect sizes enabled us to develop ecologically meaningful protection criteria, maintain statistical rigor, and provide probabilities of impairment that can be used directly in risk assessment.

Sourcebook for Biological Sciences.

ERIC Educational Resources Information Center

Troyer, Donald L.; And Others

This is a reference book of curriculum and multimedia materials, equipment and supplies, professional references, and auxiliary resource material. This sourcebook attempts to meet the needs of the classroom biology teacher and is a direct response to the many questions and concerns of both biology teachers and those preparing to become teachers.…

Invited Review Article: Current State of Research on Biological Effects of Terahertz Radiation

NASA Astrophysics Data System (ADS)

Wilmink, Gerald J.; Grundt, Jessica E.

2011-10-01

Terahertz (THz) imaging and sensing technologies are increasingly being used in a host of medical, military, and security applications. For example, THz systems are now being tested at international airports for security screening purposes, at major medical centers for cancer and burn diagnosis, and at border patrol checkpoints for identification of concealed explosives, drugs, and weapons. Recent advances in THz applications have stimulated renewed interest regarding the biological effects associated with this frequency range. Biological effects studies are a valuable type of basic science research because they serve to enhance our fundamental understanding of the mechanisms that govern THz interactions with biological systems. Such studies are also important because they often times lay the foundation for the development of future applications. In addition, from a practical standpoint, THz biological effects research is also necessary for accurate health hazard evaluation, the development of empirically-based safety standards, and for the safe use of THz systems. Given the importance and timeliness of THz bioeffects data, the purpose of this review is twofold. First, to provide readers with a common reference, which contains the necessary background concepts in biophysics and THz technology, that are required to both conduct and evaluate THz biological research. Second, to provide a critical review of the scientific literature.

14C sample preparation for AMS microdosing studies at Lund University using online combustion and septa-sealed vials

NASA Astrophysics Data System (ADS)

Sydoff, Marie; Stenström, Kristina

2010-04-01

The Department of Physics at Lund University is participating in a European Union project called EUMAPP (European Union Microdose AMS Partnership Programme), in which sample preparation and accelerator mass spectrometry (AMS) measurements of biological samples from microdosing studies have been made. This paper describes a simplified method of converting biological samples to solid graphite for 14C analysis with AMS. The method is based on online combustion of the samples, and reduction of CO 2 in septa-sealed vials. The septa-sealed vials and disposable materials are used to eliminate sample cross-contamination. Measurements of ANU and Ox I standards show deviations of 2% and 3%, respectively, relative to reference values. This level of accuracy is sufficient for biological samples from microdosing studies. Since the method has very few handling steps from sample to graphite, the risk of failure during the sample preparation process is minimized, making the method easy to use in routine preparation of samples.

[Application of traditional Chinese medicine reference standards in quality control of Chinese herbal pieces].

PubMed

Lu, Tu-Lin; Li, Jin-Ci; Yu, Jiang-Yong; Cai, Bao-Chang; Mao, Chun-Qin; Yin, Fang-Zhou

2014-01-01

Traditional Chinese medicine (TCM) reference standards plays an important role in the quality control of Chinese herbal pieces. This paper overviewed the development of TCM reference standards. By analyzing the 2010 edition of Chinese pharmacopoeia, the application of TCM reference standards in the quality control of Chinese herbal pieces was summarized, and the problems exiting in the system were put forward. In the process of improving the quality control level of Chinese herbal pieces, various kinds of advanced methods and technology should be used to research the characteristic reference standards of Chinese herbal pieces, more and more reasonable reference standards should be introduced in the quality control system of Chinese herbal pieces. This article discussed the solutions in the aspect of TCM reference standards, and future development of quality control on Chinese herbal pieces is prospected.

Metabolite profiling of a NIST Standard Reference Material for human plasma (SRM 1950): GC-MS, LC-MS, NMR, and clinical laboratory analyses, libraries, and web-based resources.

PubMed

Simón-Manso, Yamil; Lowenthal, Mark S; Kilpatrick, Lisa E; Sampson, Maureen L; Telu, Kelly H; Rudnick, Paul A; Mallard, W Gary; Bearden, Daniel W; Schock, Tracey B; Tchekhovskoi, Dmitrii V; Blonder, Niksa; Yan, Xinjian; Liang, Yuxue; Zheng, Yufang; Wallace, William E; Neta, Pedatsur; Phinney, Karen W; Remaley, Alan T; Stein, Stephen E

2013-12-17

Recent progress in metabolomics and the development of increasingly sensitive analytical techniques have renewed interest in global profiling, i.e., semiquantitative monitoring of all chemical constituents of biological fluids. In this work, we have performed global profiling of NIST SRM 1950, "Metabolites in Human Plasma", using GC-MS, LC-MS, and NMR. Metabolome coverage, difficulties, and reproducibility of the experiments on each platform are discussed. A total of 353 metabolites have been identified in this material. GC-MS provides 65 unique identifications, and most of the identifications from NMR overlap with the LC-MS identifications, except for some small sugars that are not directly found by LC-MS. Also, repeatability and intermediate precision analyses show that the SRM 1950 profiling is reproducible enough to consider this material as a good choice to distinguish between analytical and biological variability. Clinical laboratory data shows that most results are within the reference ranges for each assay. In-house computational tools have been developed or modified for MS data processing and interactive web display. All data and programs are freely available online at http://peptide.nist.gov/ and http://srmd.nist.gov/ .

Oakland County Science Safety Series: Reference Guide for Biology.

ERIC Educational Resources Information Center

Bury, Dan; And Others

This reference guide is designed to organize and suggest acceptable practices and procedures for dealing with safety in the area of biology instruction. It is intended as a reference for teachers, administrators, and other school staff in planning for science activities and in making daily safety decisions. Discussions deal with responsibility for…

Consistent design schematics for biological systems: standardization of representation in biological engineering

PubMed Central

Matsuoka, Yukiko; Ghosh, Samik; Kitano, Hiroaki

2009-01-01

The discovery by design paradigm driving research in synthetic biology entails the engineering of de novo biological constructs with well-characterized input–output behaviours and interfaces. The construction of biological circuits requires iterative phases of design, simulation and assembly, leading to the fabrication of a biological device. In order to represent engineered models in a consistent visual format and further simulating them in silico, standardization of representation and model formalism is imperative. In this article, we review different efforts for standardization, particularly standards for graphical visualization and simulation/annotation schemata adopted in systems biology. We identify the importance of integrating the different standardization efforts and provide insights into potential avenues for developing a common framework for model visualization, simulation and sharing across various tools. We envision that such a synergistic approach would lead to the development of global, standardized schemata in biology, empowering deeper understanding of molecular mechanisms as well as engineering of novel biological systems. PMID:19493898

Rheological and molecular weight comparisons of approved hyaluronic acid products - preliminary standards for establishing class III medical device equivalence.

PubMed

Braithwaite, Gavin J C; Daley, Michael J; Toledo-Velasquez, David

2016-01-01

Hyaluronic acid of various molecular weights has been in use for the treatment of osteoarthritis knee pain for decades. Worldwide, these products are regulated as either as drugs or devices and in some countries as both. In the US, this class of products is regulated as Class III medical devices, which places specific regulatory requirements on developers of these materials under a Pre-Market Approval process, typically requiring data from prospective randomized controlled clinical studies. In 1984 pharmaceutical manufacturers became able to file an Abbreviated New Drug Application for approval of a generic drug, thus establishing standards for demonstrating equivalence to an existing chemical entity. Recently, the first biosimilar, or 'generic biologic', was approved. Biosimilars are biological products that are approved by the FDA because they are 'highly similar' to a reference product, and have been shown to have no clinically meaningful differences from the reference product. For devices, Class II medical devices have a pathway for declaring equivalence to an existing product by filing a 510 k application for FDA clearance. However, until recently no equivalent regulatory pathway was available to Class III devices. In this paper, we consider the critical mechanical performance parameters for intra-articular hyaluronic products to demonstrate indistinguishable characteristics. Analogous to the aforementioned pathways that allow for a demonstration of equivalence, we examine these parameters for an existing, marketed device and compare molecular weight and rheological properties of multiple batches of a similar product. We propose that this establishes a scientific rationale for establishing Class III medical device equivalence.

Chemoselective synthesis of sialic acid 1,7-lactones.

PubMed

Allevi, Pietro; Rota, Paola; Scaringi, Raffaella; Colombo, Raffaele; Anastasia, Mario

2010-08-20

The chemoselective synthesis of the 1,7-lactones of N-acetylneuraminic acid, N-glycolylneuraminic acid, and 3-deoxy-d-glycero-d-galacto-nononic acid is accomplished in two steps: a simple treatment of the corresponding free sialic acid with benzyloxycarbonyl chloride and a successive hydrogenolysis of the formed 2-benzyloxycarbonyl 1,7-lactone. The instability of the 1,7-lactones to protic solvents has been also evidenced together with the rationalization of the mechanism of their formation under acylation conditions. The results permit to dispose of authentic 1,7-sialolactones to be used as reference standards and of a procedure useful for the preparation of their isotopologues to be used as inner standards in improved analytical procedures for the gas liquid chromatography-mass spectrometry (GLC-MS) analysis of 1,7-sialolactones in biological media.

Biosimilars: biologics that meet patients' needs and healthcare economics.

PubMed

McCamish, Mark; Yoon, William; McKay, James

2016-09-01

Biologics have revolutionized medical care, yet uniform access to these effective medicines remains difficult due to the increasing costs of healthcare. As patent exclusivity on the early biologics wanes, regulatory and legal systems are adapting to bring competition to the field in the form of biosimilars. Biosimilars are biologics that offer the same clinical benefit in one or more of the same indications as the reference biologic drug and bring competition to the biologics space. Legislation creating a pathway resulting in the first US approvals of biosimilars has been in place since 2010, but the regulatory methodology and science of evaluating the sameness of two biologics has been in use for decades. The demonstration of biosimilarity is based on the "totality of the evidence" concept, in which all structural, functional, nonclinical, and clinical data for a biosimilar product are evaluated to show high similarity to the reference product. Clinical trials for biosimilars, therefore, are designed to confirm similarity, or discover clinically relevant differences between the reference product and the biosimilar, should differences exist. It is hoped that competition from biosimilars will drive biologic innovation and increase patient access to biologics.

A regional assessment of salt marsh restoration and monitoring in the Gulf of Maine

USGS Publications Warehouse

Konisky, R.A.; Burdick, D.M.; Dionne, M.; Neckles, H.A.

2006-01-01

We compiled salt marsh monitoring datasets from 36 complete or imminent restoration projects in the Gulf of Maine to assess regional monitoring and restoration practices. Data were organized by functional indicators and restoration project types (culvert replacement, excavation works, or ditch plugging) then pooled to generate mean values for indicators before restoration, after restoration, and at reference sites. Monitoring data were checked against the regional standards of a voluntary protocol for the Gulf of Maine. Data inventories showed that vegetation and salinity indicators were most frequently collected (89 and 78% of sites, respectively), whereas nekton, bird, and hydrologic measures were collected at only about half of the sites. Reference conditions were monitored at 72% of sites. Indicators were analyzed to see if project sites were degraded relative to reference areas and to detect ecological responses to restoration activities. Results showed that compared to reference areas, prerestoration sites had smaller tidal ranges, reduced salinity levels, greater cover of brackish plants species, and lower cover of halophyte plants. Following restoration, physical factors rebounded rapidly with increased flood and salinity levels after about one year, especially for culvert projects. Biological responses were less definitive and occurred over longer time frames. Plant communities trended toward recovered halophytes and reduced brackish species at 3+ years following restoration. Nekton and avian indicators were indistinguishable among reference, impacted, and restored areas. The protocol was successful in demonstrating restoration response for the region, but results were limited by regional inconsistencies in field practices and relatively few multiyear datasets. To improve future assessment capabilities, we encourage greater adherence to the standard protocol throughout the Gulf of Maine salt marsh restoration community.

Analyzing Students' Understanding of Models and Modeling Referring to the Disciplines Biology, Chemistry, and Physics

ERIC Educational Resources Information Center

Krell, Moritz; Reinisch, Bianca; Krüger, Dirk

2015-01-01

In this study, secondary school students' (N?=?617; grades 7 to 10) understanding of models and modeling was assessed using tasks which explicitly refer to the scientific disciplines of biology, chemistry, and physics and, as a control, to no scientific discipline. The students' responses are interpreted as their biology-, chemistry-, and…

Guidelines for Marine Biological Reference Collections. Unesco Reports in Marine Sciences, No. 22.

ERIC Educational Resources Information Center

Hureau, J. C.; Rice, A. L.

This manual provides practical advice on the appropriation, conservation, and documentation of a marine biological reference collection, in response to needs expressed by Mediterranean Arab countries. A reference collection is defined as a working museum containing a series of specimens with which biologists are able to compare their own material.…

Establishment of hepatitis A vaccine (inactivated, non-adsorbed) BRP batches 2 and 3.

PubMed

Morgeaux, S; Manniam, I; Variot, P; Buchheit, K H; Daas, A; Wierer, M; Costanzo, A

2015-01-01

The current hepatitis A vaccine (HAV), inactivated, non-adsorbed, European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) is used for the in vitro potency assay of HAV as prescribed by the Ph. Eur. general chapter 2.7.14 Assay of hepatitis A vaccine. This reference preparation was calibrated in 2008 through an international collaborative study and was assigned a potency of 12 IU/mL. During use of this BRP it appeared to be inapplicable in certain cases due to a low nominal antigen content. Consequently, the European Directorate for the Quality of Medicines and HealthCare (EDQM) established replacement batches for this BRP, calibrated against the 1(st) WHO International Standard (IS) for HAV (inactivated), using the standard in vitro ELISA (enzyme-linked immunosorbent assay) method validated previously. The results of the study showed that the candidate BRPs were suitable for the intended purpose, and following completion of the study, they were adopted in November 2014 by the Ph. Eur. Commission as HAV (inactivated, non-adsorbed) BRP batches 2 and 3, with an assigned potency of 1350 IU/mL, for in vitro antigen content determination by ELISA. As the amount of material in each vial largely exceeds the amount required for the performance of a single assay, the BRPs are to be aliquoted by users as single-use aliquots and refrozen below -50 °C prior to their use as reference preparations.

Eddy-Current Reference Standard

NASA Technical Reports Server (NTRS)

Ambrose, H. H., Jr.

1985-01-01

Magnetic properties of metallic reference standards duplicated and stabilized for eddy-current coil measurements over long times. Concept uses precisely machined notched samples of known annealed materials as reference standards.

A BIBLIOGRAPHY OF BIOLOGICAL APPLICATIONS OF AUTORADIOGRAPHY, 1958 THROUGH 1959

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

Johnston, M.E.

1959-08-01

This bibliography of 281 reports and published literature references on biological applications of autoradiography is a supplement to the one published July 1958 as UCRL-8400. References previously omitted are included. (J.E. D.)

Direct calibration of a reference standard against the air kerma strength primary standard, at 192Ir HDR energy.

PubMed

Rajan, K N Govinda; Selvam, T Palani; Bhatt, B C; Vijayam, M; Patki, V S; Vinatha; Pendse, A M; Kannan, V

2002-04-07

The primary standard of low air kerma rate sources or beams, maintained at the Radiological Standards Laboratory (RSL) of the Bhabha Atomic Research Centre (BARC), is a 60 cm3 spherical graphite ionization chamber. A 192Ir HDR source was standardized at the hospital site in units of air kerma strength (AKS) using this primary standard. A 400 cm3 bakelite chamber, functioning as a reference standard at the RSL for a long period, at low air kerma rates (compared to external beam dose rates), was calibrated against the primary standard. It was seen that the primary standard and the reference standard, both being of low Z, showed roughly the same scatter response and yielded the same calibration factor for the 400 cm3 reference chamber, with or without room scatter. However, any likelihood of change in the reference chamber calibration factor would necessitate the re-transport of the primary standard to the hospital site for re-calibration. Frequent transport of the primary standard can affect the long-term stability of the primary standard, due to its movement or other extraneous causes. The calibration of the reference standard against the primary standard at the RSL, for an industrial type 192Ir source maintained at the laboratory, showed excellent agreement with the hospital calibration, making it possible to check the reference chamber calibration at RSL itself. Further calibration procedures have been developed to offer traceable calibration of the hospital well ionization chambers.

Development and Evaluation of Reference Standards for Image-based Telemedicine Diagnosis and Clinical Research Studies in Ophthalmology

PubMed Central

Ryan, Michael C.; Ostmo, Susan; Jonas, Karyn; Berrocal, Audina; Drenser, Kimberly; Horowitz, Jason; Lee, Thomas C.; Simmons, Charles; Martinez-Castellanos, Maria-Ana; Chan, R.V. Paul; Chiang, Michael F.

2014-01-01

Information systems managing image-based data for telemedicine or clinical research applications require a reference standard representing the correct diagnosis. Accurate reference standards are difficult to establish because of imperfect agreement among physicians, and discrepancies between clinical vs. image-based diagnosis. This study is designed to describe the development and evaluation of reference standards for image-based diagnosis, which combine diagnostic impressions of multiple image readers with the actual clinical diagnoses. We show that agreement between image reading and clinical examinations was imperfect (689 [32%] discrepancies in 2148 image readings), as was inter-reader agreement (kappa 0.490-0.652). This was improved by establishing an image-based reference standard defined as the majority diagnosis given by three readers (13% discrepancies with image readers). It was further improved by establishing an overall reference standard that incorporated the clinical diagnosis (10% discrepancies with image readers). These principles of establishing reference standards may be applied to improve robustness of real-world systems supporting image-based diagnosis. PMID:25954463

Selection of reference standard during method development using the analytical hierarchy process.

PubMed

Sun, Wan-yang; Tong, Ling; Li, Dong-xiang; Huang, Jing-yi; Zhou, Shui-ping; Sun, Henry; Bi, Kai-shun

2015-03-25

Reference standard is critical for ensuring reliable and accurate method performance. One important issue is how to select the ideal one from the alternatives. Unlike the optimization of parameters, the criteria of the reference standard are always immeasurable. The aim of this paper is to recommend a quantitative approach for the selection of reference standard during method development based on the analytical hierarchy process (AHP) as a decision-making tool. Six alternative single reference standards were assessed in quantitative analysis of six phenolic acids from Salvia Miltiorrhiza and its preparations by using ultra-performance liquid chromatography. The AHP model simultaneously considered six criteria related to reference standard characteristics and method performance, containing feasibility to obtain, abundance in samples, chemical stability, accuracy, precision and robustness. The priority of each alternative was calculated using standard AHP analysis method. The results showed that protocatechuic aldehyde is the ideal reference standard, and rosmarinic acid is about 79.8% ability as the second choice. The determination results successfully verified the evaluation ability of this model. The AHP allowed us comprehensive considering the benefits and risks of the alternatives. It was an effective and practical tool for optimization of reference standards during method development. Copyright © 2015 Elsevier B.V. All rights reserved.

Solving the Problem: Genome Annotation Standards before the Data Deluge.

PubMed

Klimke, William; O'Donovan, Claire; White, Owen; Brister, J Rodney; Clark, Karen; Fedorov, Boris; Mizrachi, Ilene; Pruitt, Kim D; Tatusova, Tatiana

2011-10-15

The promise of genome sequencing was that the vast undiscovered country would be mapped out by comparison of the multitude of sequences available and would aid researchers in deciphering the role of each gene in every organism. Researchers recognize that there is a need for high quality data. However, different annotation procedures, numerous databases, and a diminishing percentage of experimentally determined gene functions have resulted in a spectrum of annotation quality. NCBI in collaboration with sequencing centers, archival databases, and researchers, has developed the first international annotation standards, a fundamental step in ensuring that high quality complete prokaryotic genomes are available as gold standard references. Highlights include the development of annotation assessment tools, community acceptance of protein naming standards, comparison of annotation resources to provide consistent annotation, and improved tracking of the evidence used to generate a particular annotation. The development of a set of minimal standards, including the requirement for annotated complete prokaryotic genomes to contain a full set of ribosomal RNAs, transfer RNAs, and proteins encoding core conserved functions, is an historic milestone. The use of these standards in existing genomes and future submissions will increase the quality of databases, enabling researchers to make accurate biological discoveries.

Solving the Problem: Genome Annotation Standards before the Data Deluge

PubMed Central

Klimke, William; O'Donovan, Claire; White, Owen; Brister, J. Rodney; Clark, Karen; Fedorov, Boris; Mizrachi, Ilene; Pruitt, Kim D.; Tatusova, Tatiana

2011-01-01

The promise of genome sequencing was that the vast undiscovered country would be mapped out by comparison of the multitude of sequences available and would aid researchers in deciphering the role of each gene in every organism. Researchers recognize that there is a need for high quality data. However, different annotation procedures, numerous databases, and a diminishing percentage of experimentally determined gene functions have resulted in a spectrum of annotation quality. NCBI in collaboration with sequencing centers, archival databases, and researchers, has developed the first international annotation standards, a fundamental step in ensuring that high quality complete prokaryotic genomes are available as gold standard references. Highlights include the development of annotation assessment tools, community acceptance of protein naming standards, comparison of annotation resources to provide consistent annotation, and improved tracking of the evidence used to generate a particular annotation. The development of a set of minimal standards, including the requirement for annotated complete prokaryotic genomes to contain a full set of ribosomal RNAs, transfer RNAs, and proteins encoding core conserved functions, is an historic milestone. The use of these standards in existing genomes and future submissions will increase the quality of databases, enabling researchers to make accurate biological discoveries. PMID:22180819

Predictive models for fish assemblages in eastern USA streams: implications for assessing biodiversity

USGS Publications Warehouse

Meador, Michael R.; Carlisle, Daren M.

2009-01-01

Management and conservation of aquatic systems require the ability to assess biological conditions and identify changes in biodiversity. Predictive models for fish assemblages were constructed to assess biological condition and changes in biodiversity for streams sampled in the eastern United States as part of the U.S. Geological Survey's National Water Quality Assessment Program. Separate predictive models were developed for northern and southern regions. Reference sites were designated using land cover and local professional judgment. Taxonomic completeness was quantified based on the ratio of the number of observed native fish species expected to occur to the number of expected native fish species. Models for both regions accurately predicted fish species composition at reference sites with relatively high precision and low bias. In general, species that occurred less frequently than expected (decreasers) tended to prefer riffle areas and larger substrates, such as gravel and cobble, whereas increaser species (occurring more frequently than expected) tended to prefer pools, backwater areas, and vegetated and sand substrates. In the north, the percentage of species identified as increasers and the percentage identified as decreasers were equal, whereas in the south nearly two-thirds of the species examined were identified as decreasers. Predictive models of fish species can provide a standardized indicator for consistent assessments of biological condition at varying spatial scales and critical information for an improved understanding of fish species that are potentially at risk of loss with changing water quality conditions.

Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons

PubMed Central

Goll, Guro L.

2017-01-01

Abstract Biologic therapies have become central to the long-term management of many chronic diseases, including inflammatory rheumatic diseases. Over recent years, the development and licensing pathways for biosimilars have become more standardized, and several biosimilars have been made available for patients with inflammatory rheumatic diseases, such as RA. Pre-licensing requirements for biosimilars mandate the demonstration of comparability with reference products in terms of clinical activity, safety and immunogenicity, whereas post-marketing surveillance and risk minimization requirements are set in place to ensure that long-term, real-world safety data are collected to assess biosimilars in clinical practice. These measures should provide a foundation for physician confidence in biosimilars, which can be established further through clinical experience. Biosimilars may help to fill an unmet need by improving patient access to effective biologic treatments for chronic diseases. Greater access may result in additional clinical benefits, with appropriate use of biologic therapies according to treatment guidelines being associated with improved outcomes and the potential for reduced costs of care. Key challenges for the integration of biosimilars into everyday practice include questions about interchangeability, switching and automatic substitution. Several switching studies have shown that biosimilars can be used in place of reference products while maintaining efficacy and safety. Additional ongoing studies and registries may help to optimize the process of switching, and different funding models are examining the optimal mechanisms to ensure effective uptake of these new treatments. PMID:28903542

Impact of calcium and TOC on biological acidification assessment in Norwegian rivers.

PubMed

Schneider, Susanne C

2011-02-15

Acidification continues to be a major impact in freshwaters of northern Europe, and the biotic response to chemical recovery from acidification is often not a straightforward process. The focus on biological recovery is relevant within the context of the EU Water Framework Directive, where a biological monitoring system is needed that detects differences in fauna and flora compared to undisturbed reference conditions. In order to verify true reference sites for biological analyses, expected river pH is modeled based on Ca and TOC, and 94% of variability in pH at reference sites is explained by Ca alone, while 98% is explained by a combination of Ca and TOC. Based on 59 samples from 28 reference sites, compared to 547 samples from 285 non-reference sites, the impact of calcium and total organic carbon (TOC) on benthic algae species composition, expressed as acidification index periphyton (AIP), is analyzed. Rivers with a high Ca concentration have a naturally higher AIP, and TOC affects reference AIP only at low Ca concentrations. Four biological river types are needed for assessment of river acidification in Norway based on benthic algae: very calcium-poor, humic rivers (Ca<1 mg/l and TOC>2 mg/l); very calcium-poor, clear rivers (Ca<1 mg/l and TOC<2 mg/l); calcium-poor rivers (Ca between 1 and 4 mg/l); moderately calcium rich rivers (Ca>4 mg/l). A biological assessment system for river acidification in Norway based on benthic algae is presented, following the demands of the Water Framework Directive. Copyright © 2010 Elsevier B.V. All rights reserved.

15 CFR 200.105 - Standard reference data.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., PROCEDURES, AND FEES § 200.105 Standard reference data. Data on the physical and chemical properties of the... application in research, development, engineering design, and commerce. The Office of Standard Reference Data... Physical and Chemical Reference Data, published jointly with the American Chemical Society and the American...

15 CFR 200.105 - Standard reference data.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., PROCEDURES, AND FEES § 200.105 Standard reference data. Data on the physical and chemical properties of the... application in research, development, engineering design, and commerce. The Office of Standard Reference Data... Physical and Chemical Reference Data, published jointly with the American Chemical Society and the American...

15 CFR 200.105 - Standard reference data.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., PROCEDURES, AND FEES § 200.105 Standard reference data. Data on the physical and chemical properties of the... application in research, development, engineering design, and commerce. The Office of Standard Reference Data... Physical and Chemical Reference Data, published jointly with the American Chemical Society and the American...

15 CFR 200.105 - Standard reference data.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., PROCEDURES, AND FEES § 200.105 Standard reference data. Data on the physical and chemical properties of the... application in research, development, engineering design, and commerce. The Office of Standard Reference Data... Physical and Chemical Reference Data, published jointly with the American Chemical Society and the American...

An index of biological integrity (IBI) for Pacific Northwest rivers

USGS Publications Warehouse

Mebane, C.A.; Maret, T.R.; Hughes, R.M.

2003-01-01

The index of biotic integrity (IBI) is a commonly used measure of relative aquatic ecosystem condition; however, its application to coldwater rivers over large geographic areas has been limited. A seven-step process was used to construct and test an IBI applicable to fish assemblages in coldwater rivers throughout the U.S. portion of the Pacific Northwest. First, fish data from the region were compiled from previous studies and candidate metrics were selected. Second, reference conditions were estimated from historical reports and minimally disturbed reference sites in the region. Third, data from the upper Snake River basin were used to test metrics and develop the initial index. Fourth, candidate metrics were evaluated for their redundancy, variability, precision, and ability to reflect a wide range of conditions while distinguishing reference sites from disturbed sites. Fifth, the selected metrics were standardized by being scored continuously from 0 to 1 and then weighted as necessary to produce an IBI ranging from 0 to 100. The resulting index included 10 metrics: number of native coldwater species, number of age-classes of sculpins Cottus spp., percentage of sensitive native individuals, percentage of coldwater individuals, percentage of tolerant individuals, number of alien species, percentage of common carp Cyprinus carpio individuals, number of selected salmonid age-classes, catch per unit effort of coldwater individuals, and percentage of individuals with selected anomalies. Sixth, the IBI responses were tested with additional data sets from throughout the Pacific Northwest. Last, scores from two minimally disturbed reference rivers were evaluated for longitudinal gradients along the river continuum. The IBI responded to environmental disturbances and was spatially and temporally stable at over 150 sites in the Pacific Northwest. The results support its use across a large geographic area to describe the relative biological condition of coolwater and coldwater rivers with low species richness.

The Planteome database: an integrated resource for reference ontologies, plant genomics and phenomics

PubMed Central

Cooper, Laurel; Meier, Austin; Laporte, Marie-Angélique; Elser, Justin L; Mungall, Chris; Sinn, Brandon T; Cavaliere, Dario; Carbon, Seth; Dunn, Nathan A; Smith, Barry; Qu, Botong; Preece, Justin; Zhang, Eugene; Todorovic, Sinisa; Gkoutos, Georgios; Doonan, John H; Stevenson, Dennis W; Arnaud, Elizabeth

2018-01-01

Abstract The Planteome project (http://www.planteome.org) provides a suite of reference and species-specific ontologies for plants and annotations to genes and phenotypes. Ontologies serve as common standards for semantic integration of a large and growing corpus of plant genomics, phenomics and genetics data. The reference ontologies include the Plant Ontology, Plant Trait Ontology and the Plant Experimental Conditions Ontology developed by the Planteome project, along with the Gene Ontology, Chemical Entities of Biological Interest, Phenotype and Attribute Ontology, and others. The project also provides access to species-specific Crop Ontologies developed by various plant breeding and research communities from around the world. We provide integrated data on plant traits, phenotypes, and gene function and expression from 95 plant taxa, annotated with reference ontology terms. The Planteome project is developing a plant gene annotation platform; Planteome Noctua, to facilitate community engagement. All the Planteome ontologies are publicly available and are maintained at the Planteome GitHub site (https://github.com/Planteome) for sharing, tracking revisions and new requests. The annotated data are freely accessible from the ontology browser (http://browser.planteome.org/amigo) and our data repository. PMID:29186578

Fluorescent nanosensors for intracellular measurements: synthesis, characterization, calibration, and measurement

PubMed Central

Desai, Arpan S.; Chauhan, Veeren M.; Johnston, Angus P. R.; Esler, Tim; Aylott, Jonathan W.

2013-01-01

Measurement of intracellular acidification is important for understanding fundamental biological pathways as well as developing effective therapeutic strategies. Fluorescent pH nanosensors are an enabling technology for real-time monitoring of intracellular acidification. The physicochemical characteristics of nanosensors can be engineered to target specific cellular compartments and respond to external stimuli. Therefore, nanosensors represent a versatile approach for probing biological pathways inside cells. The fundamental components of nanosensors comprise a pH-sensitive fluorophore (signal transducer) and a pH-insensitive reference fluorophore (internal standard) immobilized in an inert non-toxic matrix. The inert matrix prevents interference of cellular components with the sensing elements as well as minimizing potentially harmful effects of some fluorophores on cell function. Fluorescent nanosensors are synthesized using standard laboratory equipment and are detectable by non-invasive widely accessible imaging techniques. The outcomes of studies employing this technology are dependent on reliable methodology for performing measurements. In particular, special consideration must be given to conditions for sensor calibration, uptake conditions and parameters for image analysis. We describe procedures for: (1) synthesis and characterization of polyacrylamide and silica based nanosensors, (2) nanosensor calibration and (3) performing measurements using fluorescence microscopy. PMID:24474936

Designing image segmentation studies: Statistical power, sample size and reference standard quality.

PubMed

Gibson, Eli; Hu, Yipeng; Huisman, Henkjan J; Barratt, Dean C

2017-12-01

Segmentation algorithms are typically evaluated by comparison to an accepted reference standard. The cost of generating accurate reference standards for medical image segmentation can be substantial. Since the study cost and the likelihood of detecting a clinically meaningful difference in accuracy both depend on the size and on the quality of the study reference standard, balancing these trade-offs supports the efficient use of research resources. In this work, we derive a statistical power calculation that enables researchers to estimate the appropriate sample size to detect clinically meaningful differences in segmentation accuracy (i.e. the proportion of voxels matching the reference standard) between two algorithms. Furthermore, we derive a formula to relate reference standard errors to their effect on the sample sizes of studies using lower-quality (but potentially more affordable and practically available) reference standards. The accuracy of the derived sample size formula was estimated through Monte Carlo simulation, demonstrating, with 95% confidence, a predicted statistical power within 4% of simulated values across a range of model parameters. This corresponds to sample size errors of less than 4 subjects and errors in the detectable accuracy difference less than 0.6%. The applicability of the formula to real-world data was assessed using bootstrap resampling simulations for pairs of algorithms from the PROMISE12 prostate MR segmentation challenge data set. The model predicted the simulated power for the majority of algorithm pairs within 4% for simulated experiments using a high-quality reference standard and within 6% for simulated experiments using a low-quality reference standard. A case study, also based on the PROMISE12 data, illustrates using the formulae to evaluate whether to use a lower-quality reference standard in a prostate segmentation study. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Reference Standard Test and the Diagnostic Ability of Spectral Domain Optical Coherence Tomography in Glaucoma.

PubMed

Rao, Harsha L; Yadav, Ravi K; Addepalli, Uday K; Begum, Viquar U; Senthil, Sirisha; Choudhari, Nikhil S; Garudadri, Chandra S

2015-08-01

To evaluate the relationship between the reference standard used to diagnose glaucoma and the diagnostic ability of spectral domain optical coherence tomograph (SDOCT). In a cross-sectional study, 280 eyes of 175 consecutive subjects, referred to a tertiary eye care center for glaucoma evaluation, underwent optic disc photography, visual field (VF) examination, and SDOCT examination. The cohort was divided into glaucoma and control groups based on 3 reference standards for glaucoma diagnosis: first based on the optic disc classification (179 glaucoma and 101 control eyes), second on VF classification (glaucoma hemifield test outside normal limits and pattern SD with P-value of <5%, 130 glaucoma and 150 control eyes), and third on the presence of both glaucomatous optic disc and glaucomatous VF (125 glaucoma and 155 control eyes). Relationship between the reference standards and the diagnostic parameters of SDOCT were evaluated using areas under the receiver operating characteristic curve, sensitivity, and specificity. Areas under the receiver operating characteristic curve and sensitivities of most of the SDOCT parameters obtained with the 3 reference standards (ranging from 0.74 to 0.88 and 72% to 88%, respectively) were comparable (P>0.05). However, specificities of SDOCT parameters were significantly greater (P<0.05) with optic disc classification as reference standard (74% to 88%) compared with VF classification as reference standard (57% to 74%). Diagnostic parameters of SDOCT that was significantly affected by reference standard was the specificity, which was greater with optic disc classification as the reference standard. This has to be considered when comparing the diagnostic ability of SDOCT across studies.

Hypoxia-induced expression of VE-cadherin and filamin B in glioma cell cultures and pseudopalisade structures.

PubMed

Nissou, Marie-France; El Atifi, Michèle; Guttin, Audrey; Godfraind, Catherine; Salon, Caroline; Garcion, Emmanuel; van der Sanden, Boudewijn; Issartel, Jean-Paul; Berger, François; Wion, Didier

2013-06-01

Most of our knowledge regarding glioma cell biology comes from cell culture experiments. For many years the standards for glioma cell culture were the use of cell lines cultured in the presence of serum and 20 % O2. However, in vivo, normoxia in many brain areas is in close to 3 % O2. Hence, in cell culture, the experimental value referred as the norm is hyperoxic compared to any brain physiological value. Likewise, cells in vivo are not usually exposed to serum, and low-passaged glioma neurosphere cultures maintained in serum-free medium is emerging as a new standard. A consequence of changing the experimental normoxic standard from 20 % O2 to the more brain physiological value of 3 % O2, is that a 3 % O2 normoxic reference point enabled a more rigorous characterization of the level of regulation of genes by hypoxia. Among the glioma hypoxia-regulated genes characterized using this approach we found VE-cadherin that is required for blood vessel formation, and filamin B a gene involved in endothelial cell motility. Both VE-cadherin and filamin B were found expressed in pseudopalisades, a glioblastoma pathognomonic structure made of hypoxic migrating cancer cells. These results provide additional clues on the role played by hypoxia in the acquisition of endothelial traits by glioma cells and on the functional links existing between pseudopalisades, hypoxia, and tumor progression.

Determination of isoflavones in soy and selected foods containing soy by extraction, saponification, and liquid chromatography: collaborative study.

PubMed

Klump, S P; Allred, M C; MacDonald, J L; Ballam, J M

2001-01-01

Isoflavones are biologically active compounds occurring naturally in a variety of plants, with relatively high levels found in soybeans. Twelve laboratories participated in a collaborative study to determine the aglycon isoflavone content of 8 test samples of soy and foods containing soy. The analytical method for the determination of isoflavones incorporates a mild saponification step that reduces the number of analytes measured and permits quantitation versus commercially available, stable reference standards. Test samples were extracted at 65 degrees C with methanol-water (80 + 20), saponified with dilute sodium hydroxide solution, and analyzed by reversed-phase liquid chromatography with UV detection at 260 nm. Isoflavone results were reported as microg/aglycon/g or microg aglycon equivalents/g. The 8 test samples included 2 blind duplicates and 4 single test samples with total isoflavone concentrations ranging from approximately 50 to 3000 microg/g. Test samples of soy ingredients and products made with soy were distributed to collaborators with appropriate reference standards. Collaborators were asked to analyze test samples in duplicate on 2 separate days. The data were analyzed for individual isoflavone components, subtotals of daidzin-daidzein, glycitin-glycitein, and genistin-genistein, and total isoflavones. The relative standard deviation (RSD) for repeatability was 1.8-7.1%, and the RSD for reproducibility was 3.2-16.1% for total isoflavone values of 47-3099 microg/g.

A conodont-based standard reference section in central Nevada for the lower Middle Ordovician Whiterockian Series

USGS Publications Warehouse

Sweet, W.C.; Ethington, Raymond L.; Harris, A.G.

2005-01-01

Ranges of conodonts in stratigraphic sections at five localities in the Monitor and Antelope ranges of central Nevada are used graphically to assemble a standard reference section for the lower Middle Ordovician Whiterockian Series. The base of the series is officially 0.3 m above the base of the Antelope Valley Limestone in the stratotype in Whiterock Canyon (Monitor Range). The top is the level at which Baltoniodus gerdae makes a brief appearance in an exposure of the Copenhagen Formation on the flanks of Hill 8308 in the western Antelope Range. Graphic compilation of the sections considered in this report also indicates that a level correlative with the base of the Whiterockian Series in the stratotype section is 66 m above the base of the Antelope Valley Limestone in its de facto type section on Martin Ridge in the eastern part of the Monitor Range. Ranges, diversity, and the composition of the conodont faunas differ markedly in lithofacies adjacent to the basal boundary of the series; hence we are unable to identify a single conodont species, in a credible developmental sequence, to serve as biological marker of that boundary.

34 CFR 73.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 1 2011-07-01 2011-07-01 false Cross-reference to employee ethical conduct standards... of Education STANDARDS OF CONDUCT § 73.1 Cross-reference to employee ethical conduct standards and... branch-wide Standards of Ethical Conduct at 5 CFR part 2635 and to the Department of Education regulation...

34 CFR 73.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Cross-reference to employee ethical conduct standards... of Education STANDARDS OF CONDUCT § 73.1 Cross-reference to employee ethical conduct standards and... branch-wide Standards of Ethical Conduct at 5 CFR part 2635 and to the Department of Education regulation...

34 CFR 73.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 34 Education 1 2014-07-01 2014-07-01 false Cross-reference to employee ethical conduct standards... of Education STANDARDS OF CONDUCT § 73.1 Cross-reference to employee ethical conduct standards and... branch-wide Standards of Ethical Conduct at 5 CFR part 2635 and to the Department of Education regulation...

34 CFR 73.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 34 Education 1 2013-07-01 2013-07-01 false Cross-reference to employee ethical conduct standards... of Education STANDARDS OF CONDUCT § 73.1 Cross-reference to employee ethical conduct standards and... branch-wide Standards of Ethical Conduct at 5 CFR part 2635 and to the Department of Education regulation...

34 CFR 73.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 34 Education 1 2012-07-01 2012-07-01 false Cross-reference to employee ethical conduct standards... of Education STANDARDS OF CONDUCT § 73.1 Cross-reference to employee ethical conduct standards and... branch-wide Standards of Ethical Conduct at 5 CFR part 2635 and to the Department of Education regulation...

Screening and advanced lipid phenotyping in familial hypercholesterolemia: The Very Large Database of Lipids Study-17 (VLDL-17).

PubMed

Miller, P Elliott; Martin, Seth S; Toth, Peter P; Santos, Raul D; Blaha, Michael J; Nasir, Khurram; Virani, Salim S; Post, Wendy S; Blumenthal, Roger S; Jones, Steven R

2015-01-01

Familial hypercholesterolemia (FH) is an autosomal dominant dyslipidemia characterized by defective low-density lipoprotein (LDL) clearance. The aim of this study was to compare Friedewald-estimated LDL cholesterol (LDL-C) to biologic LDL-C in individuals screening positive for FH and then further characterize FH phenotypes. We studied 1,320,581 individuals from the Very Large Database of Lipids, referred from 2009 to 2011 for Vertical Auto Profile ultracentrifugation testing. Friedewald LDL-C was defined as the cholesterol content of LDL-C, intermediate-density lipoprotein cholesterol, and lipoprotein(a) cholesterol (Lp(a)-C), with LDL-C representing biologic LDL-C. Using Friedewald LDL-C, we phenotypically categorized patients by the National Lipid Association guideline age-based screening thresholds for FH. In those meeting criteria, we categorized patients using population percentile-equivalent biologic LDL-C cutpoints and explored Lp(a)-C and remnant lipoprotein cholesterol (RLP-C) levels. Overall, 3829 patients met phenotypic criteria for FH by Friedewald LDL-C screening (FH+). Of those screening FH+, 78.8% were above and 21.2% were below the population percentile-equivalent biologic LDL-C. The mean difference in Friedewald biologic LDL-C percentiles was -0.01 (standard deviation, 0.17) for those above, and 1.92 (standard deviation, 9.16) for those below, respectively. Over 1 of 3 were found to have an elevated Lp(a)-C and over 50% had RLP-C greater than 95th percentile of the entire VLDL population. Of those who screened FH+, Friedewald and biologic LDL-C levels were closely correlated. Large proportions of the FH+ group had excess levels of Lp(a)-C and RLP-C. Future studies are warranted to study these mixed phenotypic groups and determine the role for further risk stratification and treatment algorithms. Copyright © 2015 National Lipid Association. Published by Elsevier Inc. All rights reserved.

7 CFR 1728.97 - Incorporation by reference of electric standards and specifications.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 11 2014-01-01 2014-01-01 false Incorporation by reference of electric standards and...) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE ELECTRIC STANDARDS AND SPECIFICATIONS FOR MATERIALS AND CONSTRUCTION § 1728.97 Incorporation by reference of electric standards and specifications. The...

7 CFR 1728.97 - Incorporation by reference of electric standards and specifications.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 11 2012-01-01 2012-01-01 false Incorporation by reference of electric standards and...) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE ELECTRIC STANDARDS AND SPECIFICATIONS FOR MATERIALS AND CONSTRUCTION § 1728.97 Incorporation by reference of electric standards and specifications. The...

Spectroscopic diagnostics for bacteria in biologic sample

DOEpatents

El-Sayed, Mostafa A.; El-Sayed, Ivan H.

2002-01-01

A method to analyze and diagnose specific bacteria in a biologic sample using spectroscopy is disclosed. The method includes obtaining the spectra of a biologic sample of a non-infected patient for use as a reference, subtracting the reference from the spectra of an infected sample, and comparing the fingerprint regions of the resulting differential spectrum with reference spectra of bacteria in saline. Using this diagnostic technique, specific bacteria can be identified sooner and without culturing, bacteria-specific antibiotics can be prescribed sooner, resulting in decreased likelihood of antibiotic resistance and an overall reduction of medical costs.

Establishment of the Ph. Eur. erythropoietin chemical reference substance batch 1.

PubMed

Burns, C; Bristow, A F; Buchheit, K H; Daas, A; Wierer, M; Costanzo, A

2015-01-01

The Erythropoietin (EPO) European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) batch 3 was calibrated in 2006 by in vivo bioassay and was used as a reference preparation for these assays as well as for the physicochemical methods in the Ph. Eur. monograph Erythropoietin concentrated solution (1316). In order to avoid the frequent replacement of this standard and thus reduce the use of animals, a new EPO Chemical Reference Substance (CRS) was established to be used solely for the physicochemical methods. Here we report the outcome of a collaborative study aimed at demonstrating the suitability of the candidate CRS (cCRS) as a reference for the physicochemical methods in the Ph. Eur. monograph. Results from the study demonstrated that for the physicochemical methods currently required in the monograph (capillary zone electrophoresis (CZE), polyacrylamide gel electrophoresis (PAGE)/immunoblotting and peptide mapping), the cCRS is essentially identical to the existing BRP. However, data also indicated that, for the physicochemical methods under consideration for inclusion in a revised monograph (test for oxidised forms and glycan mapping), the suitability of the cCRS as a reference needs to be confirmed with additional work. Further to completion of the study, the Ph. Eur. Commission adopted the cCRS as "Erythropoietin for physicochemical tests CRS batch 1" to be used for CZE, PAGE/immunoblotting and peptide mapping.

A Converter from the Systems Biology Markup Language to the Synthetic Biology Open Language.

PubMed

Nguyen, Tramy; Roehner, Nicholas; Zundel, Zach; Myers, Chris J

2016-06-17

Standards are important to synthetic biology because they enable exchange and reproducibility of genetic designs. This paper describes a procedure for converting between two standards: the Systems Biology Markup Language (SBML) and the Synthetic Biology Open Language (SBOL). SBML is a standard for behavioral models of biological systems at the molecular level. SBOL describes structural and basic qualitative behavioral aspects of a biological design. Converting SBML to SBOL enables a consistent connection between behavioral and structural information for a biological design. The conversion process described in this paper leverages Systems Biology Ontology (SBO) annotations to enable inference of a designs qualitative function.

Rational design of gold nanoparticle toxicology assays: a question of exposure scenario, dose and experimental setup.

PubMed

Taylor, Ulrike; Rehbock, Christoph; Streich, Carmen; Rath, Detlef; Barcikowski, Stephan

2014-09-01

Many studies have evaluated the toxicity of gold nanoparticles, although reliable predictions based on these results are rare. In order to overcome this problem, this article highlights strategies to improve comparability and standardization of nanotoxicological studies. To this end, it is proposed that we should adapt the nanomaterial to the addressed exposure scenario, using ligand-free nanoparticle references in order to differentiate ligand effects from size effects. Furthermore, surface-weighted particle dosing referenced to the biologically relevant parameter (e.g., cell number or organ mass) is proposed as the gold standard. In addition, it is recommended that we should shift the focus of toxicological experiments from 'live-dead' assays to the assessment of cell function, as this strategy allows observation of bioresponses at lower doses that are more relevant for in vivo scenarios.

Telemetry Standards, RCC Standard 106-17. Chapter 3. Frequency Division Multiplexing Telemetry Standards

DTIC Science & Technology

2017-07-01

any of the listed reference frequencies may be used provided the requirements for compensation rate of change are satisfied. If the reference...for in present discriminator systems when the nominal response rating of the channels is employed and a reference frequency is recorded with the...Telemetry Standards, RCC Standard 106-17 Chapter 3, July 2017 3-i CHAPTER 3 Frequency Division Multiplexing Telemetry Standards Acronyms

It's time to move on from the bell curve.

PubMed

Robinson, Lawrence R

2017-11-01

The bell curve was first described in the 18th century by de Moivre and Gauss to depict the distribution of binomial events, such as coin tossing, or repeated measures of physical objects. In the 19th and 20th centuries, the bell curve was appropriated, or perhaps misappropriated, to apply to biologic and social measures across people. For many years we used it to derive reference values for our electrophysiologic studies. There is, however, no reason to believe that electrophysiologic measures should approximate a bell-curve distribution, and empiric evidence suggests they do not. The concept of using mean ± 2 standard deviations should be abandoned. Reference values are best derived by using non-parametric analyses, such as percentile values. This proposal aligns with the recommendation of the recent normative data task force of the American Association of Neuromuscular & Electrodiagnostic Medicine and follows sound statistical principles. Muscle Nerve 56: 859-860, 2017. © 2017 Wiley Periodicals, Inc.

Data on crystal organization in the structure of the Fab fragment from the NIST reference antibody, RM 8671.

PubMed

Gallagher, D T; Karageorgos, I; Hudgens, J W; Galvin, C V

2018-02-01

The reported data describe the crystallization, crystal packing, structure determination and twinning of the unliganded Fab (antigen-binding fragment) from the NISTmAb (standard reference material 8671). The raw atomic coordinates are available as Protein Data Bank structure 5K8A and biological aspects are described in the article, (Karageorgos et al., 2017) [1]. Crystal data show that the packing is unique, and show the basis for the crystal's twinned growth. Twinning is a common and often serious problem in protein structure determination by x-ray crystallography [2]. In the present case the twinning is due to a small deviation (about 0.3 nm) from 4-fold symmetry in the primary intermolecular interface. The deviation produces pseudosymmetry, generating slightly different conformations of the protein, and alternating strong and weak forms of key packing interfaces throughout the lattice.

It’s More Than Stamp Collecting: How Genome Sequencing Can Unify Biological Research

PubMed Central

Richards, Stephen

2015-01-01

The availability of reference genome sequences, especially the human reference, has revolutionized the study of biology. However, whilst the genomes of some species have been fully sequenced, a wide range of biological problems still cannot be effectively studied for lack of genome sequence information. Here, I identify neglected areas of biology and describe how both targeted species sequencing and more broad taxonomic surveys of the tree of life can address important biological questions. I enumerate the significant benefits that would accrue from sequencing a broader range of taxa, as well as discuss the technical advances in sequencing and assembly methods that would allow for wide-ranging application of whole-genome analysis. Finally, I suggest that in addition to “Big Science” survey initiatives to sequence the tree of life, a modified infrastructure-funding paradigm would better support reference genome sequence generation for research communities most in need. PMID:26003218

It's more than stamp collecting: how genome sequencing can unify biological research.

PubMed

Richards, Stephen

2015-07-01

The availability of reference genome sequences, especially the human reference, has revolutionized the study of biology. However, while the genomes of some species have been fully sequenced, a wide range of biological problems still cannot be effectively studied for lack of genome sequence information. Here, I identify neglected areas of biology and describe how both targeted species sequencing and more broad taxonomic surveys of the tree of life can address important biological questions. I enumerate the significant benefits that would accrue from sequencing a broader range of taxa, as well as discuss the technical advances in sequencing and assembly methods that would allow for wide-ranging application of whole-genome analysis. Finally, I suggest that in addition to 'big science' survey initiatives to sequence the tree of life, a modified infrastructure-funding paradigm would better support reference genome sequence generation for research communities most in need. Copyright © 2015 Elsevier Ltd. All rights reserved.

49 CFR 1019.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 8 2011-10-01 2011-10-01 false Cross-reference to employee ethical conduct... Cross-reference to employee ethical conduct standards and financial disclosure regulations. Members and employees of the Surface Transportation Board also should refer to the executive branch Standards of Ethical...

49 CFR 1019.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 8 2010-10-01 2010-10-01 false Cross-reference to employee ethical conduct... Cross-reference to employee ethical conduct standards and financial disclosure regulations. Members and employees of the Surface Transportation Board also should refer to the executive branch Standards of Ethical...

49 CFR 1019.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 8 2014-10-01 2014-10-01 false Cross-reference to employee ethical conduct... Cross-reference to employee ethical conduct standards and financial disclosure regulations. Members and employees of the Surface Transportation Board also should refer to the executive branch Standards of Ethical...

49 CFR 1019.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 8 2013-10-01 2013-10-01 false Cross-reference to employee ethical conduct... Cross-reference to employee ethical conduct standards and financial disclosure regulations. Members and employees of the Surface Transportation Board also should refer to the executive branch Standards of Ethical...

49 CFR 1019.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 8 2012-10-01 2012-10-01 false Cross-reference to employee ethical conduct... Cross-reference to employee ethical conduct standards and financial disclosure regulations. Members and employees of the Surface Transportation Board also should refer to the executive branch Standards of Ethical...

Paediatric reference interval and biological variation trends of thyrotropin (TSH) and free thyroxine (T4) in an Asian population.

PubMed

Loh, Tze Ping; Sethi, Sunil Kumar; Metz, Michael Patrick

2015-08-01

To describe the reference intervals and biological variation data for thyrotropin (TSH) and free thyroxine (FT4) in a mixed Asian population using an indirect sampling approach and to compare them with published reports. TSH and FT4 of children measured once or twice over a 7-year period (2008-2014) at primary-care and tertiary-care settings were extracted from the laboratory information system. After excluding outliers, age-related reference intervals were derived using the Lambda-Mu-Sigma (LMS) approach, while age-partitioned biological variation data were obtained according to recommendations by Fraser and Harris. Both TSH and FT4 were very high at birth and declined with age. Similarly within-individual and between-individual biological variations were higher for both TSH and FT4 at birth and also declined with age. Our data were broadly similar to previous studies. Significant heterogeneity in study population and methods prohibited direct numerical comparison between this and previously published studies. This study fills two important gaps in our knowledge of paediatric thyroid function by reporting the centile trends (and reference values) in a mixed Asian population, as well as providing age-partitioned biological variation data. The variation in published reference intervals highlights the difficulty in harmonising paediatric thyroid reference intervals or recommending universal clinical cut-offs. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The Technical and Biological Reproducibility of Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS) Based Typing: Employment of Bioinformatics in a Multicenter Study

PubMed Central

Oberle, Michael; Wohlwend, Nadia; Jonas, Daniel; Maurer, Florian P.; Jost, Geraldine; Tschudin-Sutter, Sarah; Vranckx, Katleen; Egli, Adrian

2016-01-01

Background The technical, biological, and inter-center reproducibility of matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI TOF MS) typing data has not yet been explored. The aim of this study is to compare typing data from multiple centers employing bioinformatics using bacterial strains from two past outbreaks and non-related strains. Material/Methods Participants received twelve extended spectrum betalactamase-producing E. coli isolates and followed the same standard operating procedure (SOP) including a full-protein extraction protocol. All laboratories provided visually read spectra via flexAnalysis (Bruker, Germany). Raw data from each laboratory allowed calculating the technical and biological reproducibility between centers using BioNumerics (Applied Maths NV, Belgium). Results Technical and biological reproducibility ranged between 96.8–99.4% and 47.6–94.4%, respectively. The inter-center reproducibility showed a comparable clustering among identical isolates. Principal component analysis indicated a higher tendency to cluster within the same center. Therefore, we used a discriminant analysis, which completely separated the clusters. Next, we defined a reference center and performed a statistical analysis to identify specific peaks to identify the outbreak clusters. Finally, we used a classifier algorithm and a linear support vector machine on the determined peaks as classifier. A validation showed that within the set of the reference center, the identification of the cluster was 100% correct with a large contrast between the score with the correct cluster and the next best scoring cluster. Conclusions Based on the sufficient technical and biological reproducibility of MALDI-TOF MS based spectra, detection of specific clusters is possible from spectra obtained from different centers. However, we believe that a shared SOP and a bioinformatics approach are required to make the analysis robust and reliable. PMID:27798637

An editor for pathway drawing and data visualization in the Biopathways Workbench.

PubMed

Byrnes, Robert W; Cotter, Dawn; Maer, Andreia; Li, Joshua; Nadeau, David; Subramaniam, Shankar

2009-10-02

Pathway models serve as the basis for much of systems biology. They are often built using programs designed for the purpose. Constructing new models generally requires simultaneous access to experimental data of diverse types, to databases of well-characterized biological compounds and molecular intermediates, and to reference model pathways. However, few if any software applications provide all such capabilities within a single user interface. The Pathway Editor is a program written in the Java programming language that allows de-novo pathway creation and downloading of LIPID MAPS (Lipid Metabolites and Pathways Strategy) and KEGG lipid metabolic pathways, and of measured time-dependent changes to lipid components of metabolism. Accessed through Java Web Start, the program downloads pathways from the LIPID MAPS Pathway database (Pathway) as well as from the LIPID MAPS web server http://www.lipidmaps.org. Data arises from metabolomic (lipidomic), microarray, and protein array experiments performed by the LIPID MAPS consortium of laboratories and is arranged by experiment. Facility is provided to create, connect, and annotate nodes and processes on a drawing panel with reference to database objects and time course data. Node and interaction layout as well as data display may be configured in pathway diagrams as desired. Users may extend diagrams, and may also read and write data and non-lipidomic KEGG pathways to and from files. Pathway diagrams in XML format, containing database identifiers referencing specific compounds and experiments, can be saved to a local file for subsequent use. The program is built upon a library of classes, referred to as the Biopathways Workbench, that convert between different file formats and database objects. An example of this feature is provided in the form of read/construct/write access to models in SBML (Systems Biology Markup Language) contained in the local file system. Inclusion of access to multiple experimental data types and of pathway diagrams within a single interface, automatic updating through connectivity to an online database, and a focus on annotation, including reference to standardized lipid nomenclature as well as common lipid names, supports the view that the Pathway Editor represents a significant, practicable contribution to current pathway modeling tools.

Soilcrust References

Science.gov Websites

Soil Crust Home Crust 101 Advanced Gallery References CCERS Site Links Updated: April 24, 2006 References The complete biological soil crust reference list is available in three formats: HTML Version

From plastic to gold: a unified classification scheme for reference standards in medical image processing

NASA Astrophysics Data System (ADS)

Lehmann, Thomas M.

2002-05-01

Reliable evaluation of medical image processing is of major importance for routine applications. Nonetheless, evaluation is often omitted or methodically defective when novel approaches or algorithms are introduced. Adopted from medical diagnosis, we define the following criteria to classify reference standards: 1. Reliance, if the generation or capturing of test images for evaluation follows an exactly determined and reproducible protocol. 2. Equivalence, if the image material or relationships considered within an algorithmic reference standard equal real-life data with respect to structure, noise, or other parameters of importance. 3. Independence, if any reference standard relies on a different procedure than that to be evaluated, or on other images or image modalities than that used routinely. This criterion bans the simultaneous use of one image for both, training and test phase. 4. Relevance, if the algorithm to be evaluated is self-reproducible. If random parameters or optimization strategies are applied, reliability of the algorithm must be shown before the reference standard is applied for evaluation. 5. Significance, if the number of reference standard images that are used for evaluation is sufficient large to enable statistically founded analysis. We demand that a true gold standard must satisfy the Criteria 1 to 3. Any standard only satisfying two criteria, i.e., Criterion 1 and Criterion 2 or Criterion 1 and Criterion 3, is referred to as silver standard. Other standards are termed to be from plastic. Before exhaustive evaluation based on gold or silver standards is performed, its relevance must be shown (Criterion 4) and sufficient tests must be carried out to found statistical analysis (Criterion 5). In this paper, examples are given for each class of reference standards.

Collaborative study on saccharide quantification of the Haemophilus influenzae type b component in liquid vaccine presentations.

PubMed

Rosskopf, U; Daas, A; Terao, E; von Hunolstein, C

2017-01-01

Before release onto the market, it must be demonstrated that the total and free polysaccharide (poly ribosyl-ribitol-phosphate, PRP) content of Haemophilus influenzae type b (Hib) vaccine complies with requirements. However, manufacturers use different methods to assay PRP content: a national control laboratory must establish and validate the relevant manufacturer methodology before using it to determine PRP content. An international study was organised by the World Health Organization (WHO), in collaboration with the Biological Standardisation Programme (BSP) of the Council of Europe/European Directorate for the Quality of Medicines & HealthCare (EDQM) and of the European Union Commission, to verify the suitability of a single method for determining PRP content in liquid pentavalent vaccines (DTwP-HepB-Hib) containing a whole-cell pertussis component. It consists of HCl hydrolysis followed by chromatographic separation and quantification of ribitol on a CarboPac MA1 column using high-performance anion exchange chromatography coupled with pulsed amperometric detection (HPAEC-PAD). The unconjugated, free, PRP is separated from the total PRP using C4 solid-phase extraction cartridges (SPE C4). Ten quality control laboratories performed two independent analyses applying the proposed analytical test protocol to five vaccine samples, including a vaccine lot with sub-potent PRP content and very high free PRP content. Both WHO PRP standard and ribitol reference standard were included as calibrating standards. A significant bias between WHO PRP standard and ribitol reference standard was observed. Study results showed that the proposed analytical method is, in principle, suitable for the intended use provided that a validation is performed as usually expected from quality control laboratories.

Progeny Clustering: A Method to Identify Biological Phenotypes

PubMed Central

Hu, Chenyue W.; Kornblau, Steven M.; Slater, John H.; Qutub, Amina A.

2015-01-01

Estimating the optimal number of clusters is a major challenge in applying cluster analysis to any type of dataset, especially to biomedical datasets, which are high-dimensional and complex. Here, we introduce an improved method, Progeny Clustering, which is stability-based and exceptionally efficient in computing, to find the ideal number of clusters. The algorithm employs a novel Progeny Sampling method to reconstruct cluster identity, a co-occurrence probability matrix to assess the clustering stability, and a set of reference datasets to overcome inherent biases in the algorithm and data space. Our method was shown successful and robust when applied to two synthetic datasets (datasets of two-dimensions and ten-dimensions containing eight dimensions of pure noise), two standard biological datasets (the Iris dataset and Rat CNS dataset) and two biological datasets (a cell phenotype dataset and an acute myeloid leukemia (AML) reverse phase protein array (RPPA) dataset). Progeny Clustering outperformed some popular clustering evaluation methods in the ten-dimensional synthetic dataset as well as in the cell phenotype dataset, and it was the only method that successfully discovered clinically meaningful patient groupings in the AML RPPA dataset. PMID:26267476

28 CFR 45.1 - Cross-reference to ethical standards and financial disclosure regulations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Cross-reference to ethical standards and...) EMPLOYEE RESPONSIBILITIES § 45.1 Cross-reference to ethical standards and financial disclosure regulations. Employees of the Department of Justice are subject to the executive branch-wide Standards of Ethical Conduct...

10 CFR 1010.102 - Cross-references to employee ethical conduct standards, financial disclosure regulations, and...

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Cross-references to employee ethical conduct standards... Cross-references to employee ethical conduct standards, financial disclosure regulations, and other conduct rules. Employees of DOE are subject to the Standards of Ethical Conduct for Employees of the...

28 CFR 45.1 - Cross-reference to ethical standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Cross-reference to ethical standards and...) EMPLOYEE RESPONSIBILITIES § 45.1 Cross-reference to ethical standards and financial disclosure regulations. Employees of the Department of Justice are subject to the executive branch-wide Standards of Ethical Conduct...

10 CFR 1010.102 - Cross-references to employee ethical conduct standards, financial disclosure regulations, and...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Cross-references to employee ethical conduct standards... Cross-references to employee ethical conduct standards, financial disclosure regulations, and other conduct rules. Employees of DOE are subject to the Standards of Ethical Conduct for Employees of the...

10 CFR 1010.102 - Cross-references to employee ethical conduct standards, financial disclosure regulations, and...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Cross-references to employee ethical conduct standards... Cross-references to employee ethical conduct standards, financial disclosure regulations, and other conduct rules. Employees of DOE are subject to the Standards of Ethical Conduct for Employees of the...

28 CFR 45.1 - Cross-reference to ethical standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Cross-reference to ethical standards and...) EMPLOYEE RESPONSIBILITIES § 45.1 Cross-reference to ethical standards and financial disclosure regulations. Employees of the Department of Justice are subject to the executive branch-wide Standards of Ethical Conduct...

10 CFR 1010.102 - Cross-references to employee ethical conduct standards, financial disclosure regulations, and...

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Cross-references to employee ethical conduct standards... Cross-references to employee ethical conduct standards, financial disclosure regulations, and other conduct rules. Employees of DOE are subject to the Standards of Ethical Conduct for Employees of the...

28 CFR 45.1 - Cross-reference to ethical standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Cross-reference to ethical standards and...) EMPLOYEE RESPONSIBILITIES § 45.1 Cross-reference to ethical standards and financial disclosure regulations. Employees of the Department of Justice are subject to the executive branch-wide Standards of Ethical Conduct...

28 CFR 45.1 - Cross-reference to ethical standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Cross-reference to ethical standards and...) EMPLOYEE RESPONSIBILITIES § 45.1 Cross-reference to ethical standards and financial disclosure regulations. Employees of the Department of Justice are subject to the executive branch-wide Standards of Ethical Conduct...

A comparison of three infant skinfold reference standards: Tanner-Whitehouse, Cambridge Infant Growth Study, and WHO Child Growth Standards.

PubMed

Miller, Elizabeth M

2015-10-01

As researchers increasingly focus on early infancy as a critical period of development, there is a greater need for methodological tools that can address all aspects of infant growth. Infant skinfold measures, in particular, are measurements in need of reliable reference standards that encompass all ages of infants and provide an accurate assessment of the relative fatness of a population. This report evaluates three published reference standards for infant skinfold measurements: Tanner-Whitehouse, Cambridge Infant Growth Study, and the World Health Organization (WHO) Child Growth Standards. To assess these standards, triceps skinfolds from a population of rural Kenyan infants (n = 250) and triceps skinfolds and subscapular skinfolds from infants in the National Health and Nutrition Examination Survey 1999-2002 (NHANES; n = 1197) were calculated as z-scores from the lambda-mu-sigma curves provided by each reference population. The Tanner-Whitehouse standards represented both the Kenyan and US populations as lean, while the Cambridge standards represented both populations as overfat. The distribution of z-scores based on the WHO standards fell in the middle, but excluded infants from both populations who were below the age of 3 months. Based on these results, the WHO reference standard is the best skinfold reference standard for infants over the age of 3 months. For populations with infants of all ages, the Tanner-Whitehouse standards are recommended, despite representing both study populations as underfat. Ideally, the WHO will extend their reference standard to include infants between the ages of 0 and 3 months. © 2014 John Wiley & Sons Ltd.

Specifications of Standards in Systems and Synthetic Biology.

PubMed

Schreiber, Falk; Bader, Gary D; Golebiewski, Martin; Hucka, Michael; Kormeier, Benjamin; Le Novère, Nicolas; Myers, Chris; Nickerson, David; Sommer, Björn; Waltemath, Dagmar; Weise, Stephan

2015-09-04

Standards shape our everyday life. From nuts and bolts to electronic devices and technological processes, standardised products and processes are all around us. Standards have technological and economic benefits, such as making information exchange, production, and services more efficient. However, novel, innovative areas often either lack proper standards, or documents about standards in these areas are not available from a centralised platform or formal body (such as the International Standardisation Organisation). Systems and synthetic biology is a relatively novel area, and it is only in the last decade that the standardisation of data, information, and models related to systems and synthetic biology has become a community-wide effort. Several open standards have been established and are under continuous development as a community initiative. COMBINE, the ‘COmputational Modeling in BIology’ NEtwork has been established as an umbrella initiative to coordinate and promote the development of the various community standards and formats for computational models. There are yearly two meeting, HARMONY (Hackathons on Resources for Modeling in Biology), Hackathon-type meetings with a focus on development of the support for standards, and COMBINE forums, workshop-style events with oral presentations, discussion, poster, and breakout sessions for further developing the standards. For more information see http://co.mbine.org/. So far the different standards were published and made accessible through the standards’ web- pages or preprint services. The aim of this special issue is to provide a single, easily accessible and citable platform for the publication of standards in systems and synthetic biology. This special issue is intended to serve as a central access point to standards and related initiatives in systems and synthetic biology, it will be published annually to provide an opportunity for standard development groups to communicate updated specifications.

[Toxicological and analytical lists: chromium and its compounds].

PubMed

Minoia, C; Apostoli, P; Battaglia, A; Catenacci, G; Cottica, D; Franco, G; Pozzoli, L; Vanola, C; Candura, F; Capodaglio, E

1987-03-01

The main aspects of occupational exposure to chromium and chromium compounds are surveyed. Special attention is paid to the toxic action of this metal at the different target organs. The nutritional aspect of CrIII is examined preliminarily, and data detailing the metal contents in water and food are provided. As far the different working processes that entail occupational exposure to chromium are concerned, hygienic and environmental problems are discussed while identifying the average environment exposure to the different chemical forms of chromium (CrIII, CrIV, soluble and not soluble), as a function of the worker's tasks, and the relevant human response (total human Cr). Different hygienic and environmental standards in force in various countries and applicable to chromium compounds are compared. Additional information is given on the main aspects of chromium metabolism (absorption, distribution, excretion), and on the prevailing toxic actions, with specific reference to cancerogenesis. As far as biologic monitoring of the exposed people is concerned, the significance of Cr-U as dose-exposure indicator is discussed, also in the light of a critical review of the reference values. The report describes a series of analytical methods for the identification of chromium in aqueous and biologic matrices. The problems connected with health monitoring and fitness for work are eventually covered.

Aerospace Medicine and Biology: A Continuing Bibliography. Supplement 483

NASA Technical Reports Server (NTRS)

1999-01-01

Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion.

Synthetic Biology Open Language (SBOL) Version 2.0.0.

PubMed

Bartley, Bryan; Beal, Jacob; Clancy, Kevin; Misirli, Goksel; Roehner, Nicholas; Oberortner, Ernst; Pocock, Matthew; Bissell, Michael; Madsen, Curtis; Nguyen, Tramy; Zhang, Zhen; Gennari, John H; Myers, Chris; Wipat, Anil; Sauro, Herbert

2015-09-04

Synthetic biology builds upon the techniques and successes of genetics, molecular biology, and metabolic engineering by applying engineering principles to the design of biological systems. The field still faces substantial challenges, including long development times, high rates of failure, and poor reproducibility. One method to ameliorate these problems would be to improve the exchange of information about designed systems between laboratories. The Synthetic Biology Open Language (SBOL) has been developed as a standard to support the specification and exchange of biological design information in synthetic biology, filling a need not satisfied by other pre-existing standards. This document details version 2.0 of SBOL, introducing a standardized format for the electronic exchange of information on the structural and functional aspects of biological designs. The standard has been designed to support the explicit and unambiguous description of biological designs by means of a well defined data model. The standard also includes rules and best practices on how to use this data model and populate it with relevant design details. The publication of this specification is intended to make these capabilities more widely accessible to potential developers and users in the synthetic biology community and beyond.

42 CFR 7.6 - Exemptions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... BIOLOGICAL STANDARDS AND BIOLOGICAL PREPARATIONS § 7.6 Exemptions. State and local health departments... ministries of health of foreign governments may be exempted from paying user charges, when using biological standards or biological preparations for public health purposes. ...

A pilot study of reference vibrotactile perception thresholds on the fingertip obtained with Malaysian healthy people using ISO 13091-1 equipment.

PubMed

Daud, Roshada; Maeda, Setsuo; Kameel, Nur Nazmin Mustafa; Ripin, Muhamad Yunus; Bakrun, Norazman; Md Zein, Raemy; Kido, Masaharu; Higuchi, Kiyotaka

2004-04-01

The purpose of this paper is to clarify the reference vibrotactile perception thresholds (VPT) for healthy people in Malaysia. The measurement equipment standard, ISO 13091-1, of the vibrotactile perception thresholds for the assessment of nerve dysfunction and the analysis and interpretation of measurements at the fingertips standard, ISO 13091-2, were published in ISO/TC108/SC4/WG8 on 2001 and 2003 individually. In the ISO 13091-2 standard, the reference VPT data were obtained from few research papers. Malaysian people's VPT data don't include to this standard. In Malaysia, when the VPT is using to diagnose of the hand-arm vibration syndrome, the reference VPT data need to compare with the worker's ones. But, Malaysia does not have the reference VPT data yet. So, in this paper, the VPT was measured by using ISO 13091-1 standard equipment to obtain the reference data for Malaysian people. And these data were compared with the ISO reference data on the ISO 13091-2 standard. From the comparison of these data, it was clear that the Malaysian healthy people's VPT data were consistent with the reference data of the ISO 13091-2 standard.

The impact of US versus Indian BMD reference standards on the diagnosis of osteoporosis among South Asian Indians living in the United States

PubMed Central

Melamed, Alexander; Vittinghoff, Eric; Sriram, Usha; Schwartz, Ann V.; Kanaya, Alka M.

2010-01-01

The relationship between bone mineral density (BMD) and fracture risk is not well-established for non-white populations. There is no established BMD reference standard for South Asians. Dual energy x-ray absorptiometry (DXA) was used to measure BMD at total hip and lumbar spine in 150 US-based South Asian Indians. For each subject T-scores were calculated using BMD reference values based on US white, North Indian and South Indian populations, and the resulting WHO BMD category assignments were compared. Reference standards derived from Indian populations classified a larger proportion of US-based Indians as normal than did US white-based standards. The percentage of individuals reclassified when changing between reference standards varied by skeletal site and reference population origin, ranging from 13% (95% CI, 7–18%), when switching from US-white- to North Indian-based standard for total hip, to 40% (95% CI, 32–48%), when switching from US white to South Indian reference values for lumbar spine. These finding illustrate that choice of reference standard has a significant effect on the diagnosis of osteoporosis in South Asians, and underscore the importance of future research to quantify the relationship between BMD and fracture risk in this population. PMID:20663699

76 FR 8989 - Federal Acquisition Regulation; Updated Financial Accounting Standards Board Accounting References

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-16

... Acquisition Regulation; Updated Financial Accounting Standards Board Accounting References AGENCIES... Acquisition Regulation (FAR) to update references to authoritative accounting standards owing to the Financial... Accounting Principles (GAAP) (``Codification of GAAP''). DATES: Interested parties should submit written...

Selection of reference genes for expression analyses of red-fleshed sweet orange (Citrus sinensis).

PubMed

Pinheiro, T T; Nishimura, D S; De Nadai, F B; Figueira, A; Latado, R R

2015-12-28

Red-fleshed oranges (Citrus sinensis) contain high levels of carotenoids and lycopene. The growing consumer demand for products with health benefits has increased interest in these types of Citrus cultivars as a potential source of nutraceuticals. However, little is known about the physiology of these cultivars under Brazilian conditions. Transcriptome and gene expression analyses are important tools in the breeding and management of red-fleshed sweet orange cultivars. Reverse transcription quantitative polymerase chain reaction is a method of quantifying gene expression, but various standardizations are required to obtain precise, accurate, and specific results. Among the standardizations required, the choice of suitable stable reference genes is fundamental. The objective of this study was to evaluate the stability of 11 candidate genes using various tissue and organ samples from healthy plants or leaves from citrus greening disease (Huanglongbing)-symptomatic plants of a Brazilian red-fleshed cultivar ('Sanguínea de Mombuca'), in order to select the most suitable reference gene for investigating gene expression under these conditions. geNorm and NormFinder identified genes that encoded translation initiation factor 3, ribosomal protein L35, and translation initiation factor 5A as the most stable genes under the biological conditions tested, and genes coding actin (ACT) and the subunit of the PSI reaction center subunit III were the least stable. Phosphatase, malate dehydrogenase, and ACT were the most stable genes in the leaf samples of infected plants.

In vitro vaccine potency testing: a proposal for reducing animal use for requalification testing.

PubMed

Brown, K; Stokes, W

2012-01-01

This paper proposes a program under which the use of animals for requalification of in vitro potency tests could be eliminated. Standard References (USDA/CVB nomenclature) would be developed, characterized, stored and monitored by selected reference laboratories worldwide. These laboratories would employ scientists skilled in protein and glycoprotein chemistry and equipped with state-of-the-art instruments for required analyses. After Standard References are established, the reference laboratories would provide them to the animal health industry as "gold standards". Companies would then establish and validate a correlation between the Standard Reference and the company Master Reference (USDA/CVB nomenclature) using an internal in vitro assay. After this correlation is established, the company could use the Standard References for qualifying, monitoring and requalifying company Master References without the use of animals. Such a program would eliminate the need for animals for requalification of Master References and the need for each company to develop and validate a battery of Master Reference Monitoring assays. It would also provide advantages in terms of reduced costs and reduced time for requalification testing. As such it would provide a strong incentive for companies to develop and use in vitro assays for potency testing.

Biocoder: A programming language for standardizing and automating biology protocols

PubMed Central

2010-01-01

Background Published descriptions of biology protocols are often ambiguous and incomplete, making them difficult to replicate in other laboratories. However, there is increasing benefit to formalizing the descriptions of protocols, as laboratory automation systems (such as microfluidic chips) are becoming increasingly capable of executing them. Our goal in this paper is to improve both the reproducibility and automation of biology experiments by using a programming language to express the precise series of steps taken. Results We have developed BioCoder, a C++ library that enables biologists to express the exact steps needed to execute a protocol. In addition to being suitable for automation, BioCoder converts the code into a readable, English-language description for use by biologists. We have implemented over 65 protocols in BioCoder; the most complex of these was successfully executed by a biologist in the laboratory using BioCoder as the only reference. We argue that BioCoder exposes and resolves ambiguities in existing protocols, and could provide the software foundations for future automation platforms. BioCoder is freely available for download at http://research.microsoft.com/en-us/um/india/projects/biocoder/. Conclusions BioCoder represents the first practical programming system for standardizing and automating biology protocols. Our vision is to change the way that experimental methods are communicated: rather than publishing a written account of the protocols used, researchers will simply publish the code. Our experience suggests that this practice is tractable and offers many benefits. We invite other researchers to leverage BioCoder to improve the precision and completeness of their protocols, and also to adapt and extend BioCoder to new domains. PMID:21059251

Standard biological parts knowledgebase.

PubMed

Galdzicki, Michal; Rodriguez, Cesar; Chandran, Deepak; Sauro, Herbert M; Gennari, John H

2011-02-24

We have created the Knowledgebase of Standard Biological Parts (SBPkb) as a publically accessible Semantic Web resource for synthetic biology (sbolstandard.org). The SBPkb allows researchers to query and retrieve standard biological parts for research and use in synthetic biology. Its initial version includes all of the information about parts stored in the Registry of Standard Biological Parts (partsregistry.org). SBPkb transforms this information so that it is computable, using our semantic framework for synthetic biology parts. This framework, known as SBOL-semantic, was built as part of the Synthetic Biology Open Language (SBOL), a project of the Synthetic Biology Data Exchange Group. SBOL-semantic represents commonly used synthetic biology entities, and its purpose is to improve the distribution and exchange of descriptions of biological parts. In this paper, we describe the data, our methods for transformation to SBPkb, and finally, we demonstrate the value of our knowledgebase with a set of sample queries. We use RDF technology and SPARQL queries to retrieve candidate "promoter" parts that are known to be both negatively and positively regulated. This method provides new web based data access to perform searches for parts that are not currently possible.

RADIOISOTOPE EXPERIMENTS IN HIGH SCHOOL BIOLOGY, AN ANNOTATED SELECTED BIBLIOGRAPHY.

ERIC Educational Resources Information Center

HURLBURT, EVELYN M.

SELECTED REFERENCES ON THE USE OF RADIOISOTOPES IN BIOLOGY ARE CONTAINED IN THIS ANNOTATED BIBLIOGRAPHY FOR SECONDARY SCHOOL STUDENTS. MATERIALS INCLUDED WERE PUBLISHED AFTER 1960 AND DEAL WITH THE PROPERTIES OF RADIATION, SIMPLE RADIATION DETECTION PROCEDURES, AND TECHNIQUES FOR USING RADIOISOTOPES EXPERIMENTALLY. THE REFERENCES ARE LISTED IN…

Field Characterization of Potential Reference Sediments in the Gulf of Mexico: Chemical and Biological Quality

EPA Science Inventory

Lewis, Michael A., Jed G. Campbell, Peggy S. Harris, Darrin D. Dantin, Steve S. Foss, Robert L. Quarles, James C. Moore and Cynthia A. Chancy. Submitted. Characterization of Potential Reference Areas in the Gulf of Mexico: Near-Coastal Sediment Chemical and Biological Quality. En...

A Framework for Establishing Standard Reference Scale of Texture by Multivariate Statistical Analysis Based on Instrumental Measurement and Sensory Evaluation.

PubMed

Zhi, Ruicong; Zhao, Lei; Xie, Nan; Wang, Houyin; Shi, Bolin; Shi, Jingye

2016-01-13

A framework of establishing standard reference scale (texture) is proposed by multivariate statistical analysis according to instrumental measurement and sensory evaluation. Multivariate statistical analysis is conducted to rapidly select typical reference samples with characteristics of universality, representativeness, stability, substitutability, and traceability. The reasonableness of the framework method is verified by establishing standard reference scale of texture attribute (hardness) with Chinese well-known food. More than 100 food products in 16 categories were tested using instrumental measurement (TPA test), and the result was analyzed with clustering analysis, principal component analysis, relative standard deviation, and analysis of variance. As a result, nine kinds of foods were determined to construct the hardness standard reference scale. The results indicate that the regression coefficient between the estimated sensory value and the instrumentally measured value is significant (R(2) = 0.9765), which fits well with Stevens's theory. The research provides reliable a theoretical basis and practical guide for quantitative standard reference scale establishment on food texture characteristics.

The French Infectious Diseases Society's readiness and response to epidemic or biological risk-the current situation following the Middle East respiratory syndrome coronavirus and Ebola virus disease alerts.

PubMed

Coignard-Biehler, H; Rapp, C; Chapplain, J M; Hoen, B; Che, D; Berthelot, P; Cazenave-Roblot, F; Rabaud, C; Brouqui, P; Leport, C

2018-03-01

In 2012, the French Infectious Diseases Society (French acronym SPILF) initiated the "Coordination of epidemic and biological risk" (SPILF-COREB - Emergences [SCE]) group to support the readiness and response of healthcare workers (HCWs) to new alerts. To present the SCE group, its functioning, and the main support it provided for frontline HCWs. A multidisciplinary group of heads of infectious disease departments from reference hospitals was created to build a network of clinical expertise for care, training, and research in the field of epidemic and biological risk (EBR). The network developed a set of standardized operational procedures (SOPs) to guide interventions to manage EBR-suspect patients. A working group created the SOP aimed at frontline HCWs taking care of patients. Priority was given to the development of a generic procedure, which was then adapted according to the current alert. Five key steps were identified and hierarchized: detecting, protecting, caring for, alerting, and referring the EBR patient. The interaction between clinicians and those responsible for the protection of the community was crucial. The SOPs validated by the SPILF and its affiliates were disseminated to a wide range of key stakeholders through various media including workshops and the SPILF's website. SPILF can easily adapt and timely mobilize the EBR expertise in case of an alert. The present work suggests that sharing and discussing this experience, initiated at the European level, can generate a new collective expertise and needs to be further developed and strengthened. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Collaborative study for the establishment of replacement batches of heparin low- molecular-mass for assay biological reference preparations.

PubMed

Terao, E; Daas, A; Rautmann, G; Buchheit, K-H

2010-10-01

A collaborative study was run by the European Directorate for the Quality of Medicines & HealthCare (EDQM) in the context of the Biological Standardisation Programme (BSP), under the aegis of the Council of Europe and the European Commission, to establish replacement batches for the dwindling stocks of the Heparin low-molecular-mass for assay European Pharmacopoeia Biological Reference Preparation (BRP). The replacement batches of BRP are intended to be used in the assays for anti-Xa and anti-IIa activities, as described in the European Pharmacopoeia (Ph. Eur.) monograph Heparins, low-molecular-mass (0828). Three freeze-dried candidate batches were calibrated against the current International Standard (IS) for Heparin, lowmolecular- weight (2nd IS, 01/608). For the purpose of the continuity check between subsequent BRP batches, the current Heparin low-molecular-mass for assay BRP (batch 5) was also included in the test panel. Thirteen official medicines control and manufacturers laboratories from European and non-European countries contributed data. A central statistical analysis of the datasets was performed at the EDQM. On the basis of the results, the 3 candidate materials were assigned a potency of 104 IU/vial for the anti-Xa activity and 31 IU/vial for the anti-IIa activity. Taken into account the preliminary stability data and the results of this collaborative study, the 3 batches of candidate BRP were adopted in June 2010 by the Commission of the Ph. Eur. as Heparin low-molecular-mass for assay BRP batches 6, 7 and 8.

18 CFR 38.2 - Incorporation by reference of North American Energy Standards Board Wholesale Electric Quadrant...

Code of Federal Regulations, 2011 CFR

2011-04-01

....13, 001-1.0, 001-9.7, 001-14.1.3, and 001-15.1.2); (2) Open Access Same-Time Information Systems... reference of North American Energy Standards Board Wholesale Electric Quadrant standards. 38.2 Section 38.2... UTILITIES § 38.2 Incorporation by reference of North American Energy Standards Board Wholesale Electric...

Towards a Framework for Developing Semantic Relatedness Reference Standards

PubMed Central

Pakhomov, Serguei V.S.; Pedersen, Ted; McInnes, Bridget; Melton, Genevieve B.; Ruggieri, Alexander; Chute, Christopher G.

2010-01-01

Our objective is to develop a framework for creating reference standards for functional testing of computerized measures of semantic relatedness. Currently, research on computerized approaches to semantic relatedness between biomedical concepts relies on reference standards created for specific purposes using a variety of methods for their analysis. In most cases, these reference standards are not publicly available and the published information provided in manuscripts that evaluate computerized semantic relatedness measurement approaches is not sufficient to reproduce the results. Our proposed framework is based on the experiences of medical informatics and computational linguistics communities and addresses practical and theoretical issues with creating reference standards for semantic relatedness. We demonstrate the use of the framework on a pilot set of 101 medical term pairs rated for semantic relatedness by 13 medical coding experts. While the reliability of this particular reference standard is in the “moderate” range; we show that using clustering and factor analyses offers a data-driven approach to finding systematic differences among raters and identifying groups of potential outliers. We test two ontology-based measures of relatedness and provide both the reference standard containing individual ratings and the R program used to analyze the ratings as open-source. Currently, these resources are intended to be used to reproduce and compare results of studies involving computerized measures of semantic relatedness. Our framework may be extended to the development of reference standards in other research areas in medical informatics including automatic classification, information retrieval from medical records and vocabulary/ontology development. PMID:21044697

Hg0 and HgCl2 Reference Gas Standards: ?NIST Traceability ...

EPA Pesticide Factsheets

EPA and NIST have collaborated to establish the necessary procedures for establishing the required NIST traceability of commercially-provided Hg0 and HgCl2 reference generators. This presentation will discuss the approach of a joint EPA/NIST study to accurately quantify the true concentrations of Hg0 and HgCl2 reference gases produced from high quality, NIST-traceable, commercial Hg0 and HgCl2 generators. This presentation will also discuss the availability of HCl and Hg0 compressed reference gas standards as a result of EPA's recently approved Alternative Methods 114 and 118. Gaseous elemental mercury (Hg0) and oxidized mercury (HgCl2) reference standards are integral to the use of mercury continuous emissions monitoring systems (Hg CEMS) for regulatory compliance emissions monitoring. However, a quantitative disparity of approximately 7-10% has been observed between commercial Hg0 and HgCl2 reference gases which currently limits the use of (HgCl2) reference gas standards. Resolving this disparity would enable the expanded use of (HgCl2) reference gas standards for regulatory compliance purposes.

Simulating Biological and Non-Biological Motion

ERIC Educational Resources Information Center

Bruzzo, Angela; Gesierich, Benno; Wohlschlager, Andreas

2008-01-01

It is widely accepted that the brain processes biological and non-biological movements in distinct neural circuits. Biological motion, in contrast to non-biological motion, refers to active movements of living beings. Aim of our experiment was to investigate the mechanisms underlying mental simulation of these two movement types. Subjects had to…

Space Station Biological Research Project: Reference Experiment Book

NASA Technical Reports Server (NTRS)

Johnson, Catherine (Editor); Wade, Charles (Editor)

1996-01-01

The Space Station Biological Research Project (SSBRP), which is the combined efforts of the Centrifuge Facility (CF) and the Gravitational Biology Facility (GBF), is responsible for the development of life sciences hardware to be used on the International Space Station to support cell, developmental, and plant biology research. The SSBRP Reference Experiment Book was developed to use as a tool for guiding this development effort. The reference experiments characterize the research interests of the international scientific community and serve to identify the hardware capabilities and support equipment needed to support such research. The reference experiments also serve as a tool for understanding the operational aspects of conducting research on board the Space Station. This material was generated by the science community by way of their responses to reference experiment solicitation packages sent to them by SSBRP scientists. The solicitation process was executed in two phases. The first phase was completed in February of 1992 and the second phase completed in November of 1995. Representing these phases, the document is subdivided into a Section 1 and a Section 2. The reference experiments contained in this document are only representative microgravity experiments. They are not intended to define actual flight experiments. Ground and flight experiments will be selected through the formal NASA Research Announcement (NRA) and Announcement of Opportunity (AO) experiment solicitation, review, and selection process.

Nephele: a cloud platform for simplified, standardized and reproducible microbiome data analysis.

PubMed

Weber, Nick; Liou, David; Dommer, Jennifer; MacMenamin, Philip; Quiñones, Mariam; Misner, Ian; Oler, Andrew J; Wan, Joe; Kim, Lewis; Coakley McCarthy, Meghan; Ezeji, Samuel; Noble, Karlynn; Hurt, Darrell E

2018-04-15

Widespread interest in the study of the microbiome has resulted in data proliferation and the development of powerful computational tools. However, many scientific researchers lack the time, training, or infrastructure to work with large datasets or to install and use command line tools. The National Institute of Allergy and Infectious Diseases (NIAID) has created Nephele, a cloud-based microbiome data analysis platform with standardized pipelines and a simple web interface for transforming raw data into biological insights. Nephele integrates common microbiome analysis tools as well as valuable reference datasets like the healthy human subjects cohort of the Human Microbiome Project (HMP). Nephele is built on the Amazon Web Services cloud, which provides centralized and automated storage and compute capacity, thereby reducing the burden on researchers and their institutions. https://nephele.niaid.nih.gov and https://github.com/niaid/Nephele. darrell.hurt@nih.gov.

Nephele: a cloud platform for simplified, standardized and reproducible microbiome data analysis

PubMed Central

Weber, Nick; Liou, David; Dommer, Jennifer; MacMenamin, Philip; Quiñones, Mariam; Misner, Ian; Oler, Andrew J; Wan, Joe; Kim, Lewis; Coakley McCarthy, Meghan; Ezeji, Samuel; Noble, Karlynn; Hurt, Darrell E

2018-01-01

Abstract Motivation Widespread interest in the study of the microbiome has resulted in data proliferation and the development of powerful computational tools. However, many scientific researchers lack the time, training, or infrastructure to work with large datasets or to install and use command line tools. Results The National Institute of Allergy and Infectious Diseases (NIAID) has created Nephele, a cloud-based microbiome data analysis platform with standardized pipelines and a simple web interface for transforming raw data into biological insights. Nephele integrates common microbiome analysis tools as well as valuable reference datasets like the healthy human subjects cohort of the Human Microbiome Project (HMP). Nephele is built on the Amazon Web Services cloud, which provides centralized and automated storage and compute capacity, thereby reducing the burden on researchers and their institutions. Availability and implementation https://nephele.niaid.nih.gov and https://github.com/niaid/Nephele Contact darrell.hurt@nih.gov PMID:29028892

Determination of molybdenum in sea and estuarine water with BETA-naphthoin oxime and neutron activation

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

Kuathilake, A.I.; Chatt, A.

1980-05-01

An analytical method has been developed for the determination of submicrogram quantities of molybdenum in sea and esturaine water. The method consists of preconcentration of molybdenum with BETA-naphthoin oxime followed by the determination of the element employing neutron activation analysis. Various factors that can influence yield and selectivity of the preconcentration process have been investigated in detail. A comparison study between ..cap alpha..-benzoin oxime and BETA-naphthoin oxime in preconcentrating molybdenum has been carried out using a standard steel sample. The method has been applied to determine molybdenum content of sea and estuarine water. A detection limit of 0.32 ..mu..g Momore » L/sup -1/ seawater has been acheived. The precision and accuracy of the method have been evaluated using an intercomparison fresh water and a biological standard reference material. 1 figure, 9 tables.« less

Synthesis and α-glucosidase inhibition activity of dihydroxy pyrrolidines.

PubMed

Kasturi, Sivaprasad; Surarapu, Sujatha; Uppalanchi, Srinivas; Anireddy, Jaya Shree; Dwivedi, Shubham; Anantaraju, Hasitha Shilpa; Perumal, Yogeeswari; Sigalapalli, Dilep Kumar; Babu, Bathini Nagendra; Ethiraj, Krishna S

2017-06-15

A new series of Deacetylsarmentamide A and B derivatives, amides and sulfonamides of 3,4-dihydroxypyrrolidines as α-glucosidase inhibitors were designed and synthesized. The biological screening test against α-glucosidase showed that some of these compounds have the positive inhibitory activity against α-glucosidase. Saturated aliphatic amides were more potent than the olefinic amides. Among all the compounds, 5o/6o having polar -NH 2 group, 10f/11f having polar -OH group on phenyl ring displayed 3-4-fold more potent than the standard drugs. Acarbose, Voglibose and Miglitol were used as standard references. The promising compounds 6i, 5o, 6o, 10a, 11a, 10f and 11f have been identified. Molecular docking simulations were done for compounds to identify important binding modes responsible for inhibition activity of α-glucosidase. Copyright © 2017 Elsevier Ltd. All rights reserved.

Reevaluation of the NOAA/CMDL carbon monoxide reference scale and comparisons with CO reference gases at NASA-Langley and the Fraunhofer Institut

NASA Technical Reports Server (NTRS)

Novelli, P. C.; Collins, J. E., Jr.; Myers, R. C.; Sachse, G. W.; Scheel, H. E.

1994-01-01

The carbon monoxide (CO) reference scale created by the National Oceanic and Atmospheric Administration/Climate Monitoring and Diagnostics Laboratory (NOAA/CMDL) is used to quantify measurements of CO in the atmosphere, calibrate standards of other laboratories and to otherwise provide reference gases to the community measuring atmospheric CO. This reference scale was created based upon a set of primary standards prepared by gravimetric methods at CMDL and has been propagated to a set of working standards. In this paper we compare CO mixing ratios assigned to the working standards by three approaches: (1) calibration against the original gravimetric standards, (2) calibration using only working standards as the reference gas, and (3) calibration against three new gravimetric standards prepared to CMDL. The agreement between these values was typically better than 1%. The calibration histories of CMDL working standards are reviewed with respect to expected rates of CO change in the atmosphere. Using a Monte Carlo approach to simulate the effect of drifting standards on calculated mixing ratios, we conclude that the error solely associated with the maintenance of standards will limit the ability to detect small CO changes in the atmosphere. We also report results of intercalibration experiments conducted between CMDL and the Diode Laser Sensor Group (DACOM) at the NASA Langley Research Center (Hampton, Virginia), and CMDL and the Fraunhofer-Institut (Garmisch-Partenkirchen, Germany). Each laboratory calibrated several working standards for CO using their reference gases, and these results were compared to calibrations conducted by CMDL. The intercomparison of eight standards (CO concentrations between approximately 100 and approximately 165 ppb) by CMDL and NASA agreed to better than +/- 2%. The calibration of six standards (CO concentrations between approximately 50 and approximately 210 ppb) by CMDL and the Fraunhofer-Institut agreed to within +/- 2% for four standards, and to within +/- 5% for all six standards.

Understanding of Energy in Biology and Vitalistic Conceptions.

ERIC Educational Resources Information Center

Barak, Judith; Gorodetsky, Malka; Chipman, David

1997-01-01

Addresses the possible connection between misconceptions of energy in biological phenomena and adherence to scientifically oriented conceptions of biology. Makes recommendations for basing the biology curriculum on the second law of thermodynamics. Contains 31 references. (DDR)

22 CFR 705.101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 22 Foreign Relations 2 2011-04-01 2009-04-01 true Cross-reference to employee ethical conduct... INVESTMENT CORPORATION ADMINISTRATIVE PROVISIONS EMPLOYEE ETHICAL CONDUCT STANDARDS AND FINANCIAL DISCLOSURE REGULATIONS § 705.101 Cross-reference to employee ethical conduct standards and financial disclosure...

Certification of elements in and use of standard reference material 3280 multivitamin/multielement tablets

USDA-ARS?s Scientific Manuscript database

Standard Reference Material (SRM) 3280 Multivitamin/Multielement Tablets was issued by the National Institute of Standards and Technology (NIST) in 2009 and has certified and reference mass fraction values for 13 vitamins, 26 elements, and 2 carotenoids. Elements were measured using two or more ana...

22 CFR 705.101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 2 2010-04-01 2010-04-01 true Cross-reference to employee ethical conduct... INVESTMENT CORPORATION ADMINISTRATIVE PROVISIONS EMPLOYEE ETHICAL CONDUCT STANDARDS AND FINANCIAL DISCLOSURE REGULATIONS § 705.101 Cross-reference to employee ethical conduct standards and financial disclosure...

22 CFR 705.101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 2 2014-04-01 2014-04-01 false Cross-reference to employee ethical conduct... INVESTMENT CORPORATION ADMINISTRATIVE PROVISIONS EMPLOYEE ETHICAL CONDUCT STANDARDS AND FINANCIAL DISCLOSURE REGULATIONS § 705.101 Cross-reference to employee ethical conduct standards and financial disclosure...

22 CFR 705.101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 22 Foreign Relations 2 2013-04-01 2009-04-01 true Cross-reference to employee ethical conduct... INVESTMENT CORPORATION ADMINISTRATIVE PROVISIONS EMPLOYEE ETHICAL CONDUCT STANDARDS AND FINANCIAL DISCLOSURE REGULATIONS § 705.101 Cross-reference to employee ethical conduct standards and financial disclosure...

22 CFR 705.101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 22 Foreign Relations 2 2012-04-01 2009-04-01 true Cross-reference to employee ethical conduct... INVESTMENT CORPORATION ADMINISTRATIVE PROVISIONS EMPLOYEE ETHICAL CONDUCT STANDARDS AND FINANCIAL DISCLOSURE REGULATIONS § 705.101 Cross-reference to employee ethical conduct standards and financial disclosure...

Agreement between diagnoses reached by clinical examination and available reference standards: a prospective study of 216 patients with lumbopelvic pain

PubMed Central

Laslett, Mark; McDonald, Barry; Tropp, Hans; Aprill, Charles N; Öberg, Birgitta

2005-01-01

Background The tissue origin of low back pain (LBP) or referred lower extremity symptoms (LES) may be identified in about 70% of cases using advanced imaging, discography and facet or sacroiliac joint blocks. These techniques are invasive and availability varies. A clinical examination is non-invasive and widely available but its validity is questioned. Diagnostic studies usually examine single tests in relation to single reference standards, yet in clinical practice, clinicians use multiple tests and select from a range of possible diagnoses. There is a need for studies that evaluate the diagnostic performance of clinical diagnoses against available reference standards. Methods We compared blinded clinical diagnoses with diagnoses based on available reference standards for known causes of LBP or LES such as discography, facet, sacroiliac or hip joint blocks, epidurals injections, advanced imaging studies or any combination of these tests. A prospective, blinded validity design was employed. Physiotherapists examined consecutive patients with chronic lumbopelvic pain and/or referred LES scheduled to receive the reference standard examinations. When diagnoses were in complete agreement regardless of complexity, "exact" agreement was recorded. When the clinical diagnosis was included within the reference standard diagnoses, "clinical agreement" was recorded. The proportional chance criterion (PCC) statistic was used to estimate agreement on multiple diagnostic possibilities because it accounts for the prevalence of individual categories in the sample. The kappa statistic was used to estimate agreement on six pathoanatomic diagnoses. Results In a sample of chronic LBP patients (n = 216) with high levels of disability and distress, 67% received a patho-anatomic diagnosis based on available reference standards, and 10% had more than one tissue origin of pain identified. For 27 diagnostic categories and combinations, chance clinical agreement (PCC) was estimated at 13%. "Exact" agreement between clinical and reference standard diagnoses was 32% and "clinical agreement" 51%. For six pathoanatomic categories (disc, facet joint, sacroiliac joint, hip joint, nerve root and spinal stenosis), PCC was 33% with actual agreement 56%. There was no overlap of 95% confidence intervals on any comparison. Diagnostic agreement on the six most common patho-anatomic categories produced a kappa of 0.31. Conclusion Clinical diagnoses agree with reference standards diagnoses more often than chance. Using available reference standards, most patients can have a tissue source of pain identified. PMID:15943873

Thermal Conductivity Measurement of Anisotropic Biological Tissue In Vitro

NASA Astrophysics Data System (ADS)

Yue, Kai; Cheng, Liang; Yang, Lina; Jin, Bitao; Zhang, Xinxin

2017-06-01

The accurate determination of the thermal conductivity of biological tissues has implications on the success of cryosurgical/hyperthermia treatments. In light of the evident anisotropy in some biological tissues, a new modified stepwise transient method was proposed to simultaneously measure the transverse and longitudinal thermal conductivities of anisotropic biological tissues. The physical and mathematical models were established, and the analytical solution was derived. Sensitivity analysis and experimental simulation were performed to determine the feasibility and measurement accuracy of simultaneously measuring the transverse and longitudinal thermal conductivities. The experimental system was set up, and its measurement accuracy was verified by measuring the thermal conductivity of a reference standard material. The thermal conductivities of the pork tenderloin and bovine muscles were measured using the traditional 1D and proposed methods, respectively, at different temperatures. Results indicate that the thermal conductivities of the bovine muscle are lower than those of the pork tenderloin muscle, whereas the bovine muscle was determined to exhibit stronger anisotropy than the pork tenderloin muscle. Moreover, the longitudinal thermal conductivity is larger than the transverse thermal conductivity for the two tissues and all thermal conductivities increase with the increase in temperature. Compared with the traditional 1D method, results obtained by the proposed method are slightly higher although the relative deviation is below 5 %.

Importance of Data Management in a Long-term Biological Monitoring Program

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

Christensen, Sigurd W; Brandt, Craig C; McCracken, Kitty

2011-01-01

The long-term Biological Monitoring and Abatement Program (BMAP) has always needed to collect and retain high-quality data on which to base its assessments of ecological status of streams and their recovery after remediation. Its formal quality assurance, data processing, and data management components all contribute to this need. The Quality Assurance Program comprehensively addresses requirements from various institutions, funders, and regulators, and includes a data management component. Centralized data management began a few years into the program. An existing relational database was adapted and extended to handle biological data. Data modeling enabled the program's database to process, store, and retrievemore » its data. The data base's main data tables and several key reference tables are described. One of the most important related activities supporting long-term analyses was the establishing of standards for sampling site names, taxonomic identification, flagging, and other components. There are limitations. Some types of program data were not easily accommodated in the central systems, and many possible data-sharing and integration options are not easily accessible to investigators. The implemented relational database supports the transmittal of data to the Oak Ridge Environmental Information System (OREIS) as the permanent repository. From our experience we offer data management advice to other biologically oriented long-term environmental sampling and analysis programs.« less

Phallometric comparison of pedophilic interest in nonadmitting sexual offenders against stepdaughters, biological daughters, other biologically related girls, and unrelated girls.

PubMed

Blanchard, Ray; Kuban, Michael E; Blak, Thomas; Cantor, James M; Klassen, Philip; Dickey, Robert

2006-01-01

This study compared the mean levels of sexual response to children produced by four groups of men with sexual offences against prepubescent girls and two comparison groups with other offences or no offences. All groups (N = 291) consisted of patients referred for clinical assessment of their sexual behavior or interests. Group assignment was determined by the victim's age and her relation to the patient: biological daughter; stepdaughter; other biologically related girl (e.g., sister, niece, granddaughter); unrelated girl; adult woman; and no known victim. The men with sexual offences had precisely one known victim each. The patients with offences may or may not have denied the act of which they were accused, but all patients denied an erotic preference for children. Sexual response to children was assessed by means of phallometric testing, a psychophysiological technique in which the individual's penile blood volume is monitored while he is presented with a standardized set of laboratory stimuli depicting male and female children and adults. The results indicated that the mean level of pedophilic response in men with offences against daughters or stepdaughters is intermediate between that in men with offences against otherwise-related or unrelated girls and that in men with no offences against girls at all.

Importance of Data Management in a Long-Term Biological Monitoring Program

NASA Astrophysics Data System (ADS)

Christensen, Sigurd W.; Brandt, Craig C.; McCracken, Mary K.

2011-06-01

The long-term Biological Monitoring and Abatement Program (BMAP) has always needed to collect and retain high-quality data on which to base its assessments of ecological status of streams and their recovery after remediation. Its formal quality assurance, data processing, and data management components all contribute to meeting this need. The Quality Assurance Program comprehensively addresses requirements from various institutions, funders, and regulators, and includes a data management component. Centralized data management began a few years into the program when an existing relational database was adapted and extended to handle biological data. The database's main data tables and several key reference tables are described. One of the most important related activities supporting long-term analyses was the establishing of standards for sampling site names, taxonomic identification, flagging, and other components. The implemented relational database supports the transmittal of data to the Oak Ridge Environmental Information System (OREIS) as the permanent repository. We also discuss some limitations to our implementation. Some types of program data were not easily accommodated in the central systems, and many possible data-sharing and integration options are not easily accessible to investigators. From our experience we offer data management advice to other biologically oriented long-term environmental sampling and analysis programs.

Alternative mass reference standards for direct analysis in real time mass spectrometry.

PubMed

Cody, Robert B; Dane, A John

2016-05-30

Mass spectra were acquired with the Direct Analysis in Real Time (DART®) ion source for an amine-terminated polyether used as positive-ion mass reference standards and for several fluorinated materials commonly used as negative-ion reference standards for mass spectrometry. A commercial time-of-flight mass spectrometer equipped with a DART ion source was used for all measurements. Mass reference standards deposited onto the sealed end of a glass melting point tube were suspended in the DART gas stream for analysis. A polyetheramine (Jeffamine® M-600) produced intense peaks corresponding to protonated molecules. Perfluorotributylamine (PFTBA), and perfluorotripentylamine, gave useful reference spectra for different m/z ranges. DART mass spectra of Ultramark 1621® resembled those previously reported for Fast Atom Bombardment (FAB) and Electrospray Ionization (ESI). Fomblin®Y, a fluorinated ether, was the most useful negative-ion reference standard of the materials tested. The material is commercially available, inexpensive, and provides reference peaks covering the m/z range 85 to >3000. Jeffamine-M600 was found to be a convenient alternative to polyethers such as polyethylene glycol (PEG) for DART positive-ion mass calibration. Fomblin Y was suitable for use as a negative-ion reference standard. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

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.

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

Updating OSHA standards based on national consensus standards. Direct final rule.

PubMed

2007-12-14

In this direct final rule, the Agency is removing several references to consensus standards that have requirements that duplicate, or are comparable to, other OSHA rules; this action includes correcting a paragraph citation in one of these OSHA rules. The Agency also is removing a reference to American Welding Society standard A3.0-1969 ("Terms and Definitions") in its general-industry welding standards. This rulemaking is a continuation of OSHA's ongoing effort to update references to consensus and industry standards used throughout its rules.

Optical-Fiber Power Meter Comparison between NIST and KRISS.

PubMed

Vayshenker, I; Kim, S K; Hong, K; Lee, D-H; Livigni, D J; Li, X; Lehman, J H

2012-01-01

We describe the results of a comparison of reference standards between the National Institute of Standards and Technology (NIST-USA) and Korea Research Institute of Standards and Science (KRISS-R.O. Korea) for optical fiber-based power measurements at wavelengths of 1302 nm and 1546 nm. We compare the laboratories' reference standards by means of a temperature-controlled optical trap detector. Measurement results showed the largest difference of less than 2.5 parts in 10(3), which is within the combined standard (k=1) uncertainty for the two laboratories' reference standards.

Physicochemical and biological characterization of SB2, a biosimilar of Remicade® (infliximab)

PubMed Central

Hong, Juyong; Lee, Yuhwa; Lee, Changsoo; Eo, Suhyeon; Kim, Soyeon; Park, Seungkyu; Seo, Donghyuck; Lee, Youngji; Yeon, Soojeong; Bou-Assaf, George; Sosic, Zoran; Zhang, Wei

2017-01-01

ABSTRACT A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product. Biosimilarity to the reference product (RP) in terms of quality characteristics, such as physicochemical and biological properties, safety, and efficacy, based on a comprehensive comparability exercise needs to be established. SB2 (Flixabi® and Renflexis®) is a biosimilar to Remicade® (infliximab). The development of SB2 was performed in accordance with relevant guidelines of the International Conference on Harmonisation, the European Medicines Agency, and the United States Food and Drug Administration. To determine whether critical quality attributes meet quality standards, an extensive characterization test was performed with more than 80 lots of EU- and US-sourced RP. The physicochemical characterization study results revealed that SB2 was similar to the RP. Although a few differences in physicochemical attributes were observed, the evidence from the related literature, structure-activity relationship studies, and comparative biological assays showed that these differences were unlikely to be clinically meaningful. The biological characterization results showed that SB2 was similar to the RP in terms of tumor necrosis factor–α (TNF-α) binding and TNF-α neutralization activities as a main mode of action. SB2 was also similar in Fc-related biological activities including antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, neonatal Fc receptor binding, C1q binding, and Fc gamma receptor binding activities. These analytical findings support that SB2 is similar to the RP and also provide confidence of biosimilarity in terms of clinical safety and efficacy. PMID:28005456

Standard Biological Parts Knowledgebase

PubMed Central

Galdzicki, Michal; Rodriguez, Cesar; Chandran, Deepak; Sauro, Herbert M.; Gennari, John H.

2011-01-01

We have created the Knowledgebase of Standard Biological Parts (SBPkb) as a publically accessible Semantic Web resource for synthetic biology (sbolstandard.org). The SBPkb allows researchers to query and retrieve standard biological parts for research and use in synthetic biology. Its initial version includes all of the information about parts stored in the Registry of Standard Biological Parts (partsregistry.org). SBPkb transforms this information so that it is computable, using our semantic framework for synthetic biology parts. This framework, known as SBOL-semantic, was built as part of the Synthetic Biology Open Language (SBOL), a project of the Synthetic Biology Data Exchange Group. SBOL-semantic represents commonly used synthetic biology entities, and its purpose is to improve the distribution and exchange of descriptions of biological parts. In this paper, we describe the data, our methods for transformation to SBPkb, and finally, we demonstrate the value of our knowledgebase with a set of sample queries. We use RDF technology and SPARQL queries to retrieve candidate “promoter” parts that are known to be both negatively and positively regulated. This method provides new web based data access to perform searches for parts that are not currently possible. PMID:21390321

77 FR 181 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-55; Introduction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-03

... System. VI Updated Financial 2010-005 Chambers. Accounting Standards Board Accounting References. VII... Financial Accounting Standards Board Accounting References (FAR Case 2010-005) This final rule amends the... authoritative accounting standards owing to the Financial Accounting Standards Board's Accounting Standards...

10 CFR 50.150 - Aircraft impact assessment.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 13, 2009; (B) Renewal of standard design certifications in effect on July 13, 2009 which have not..., standard design approval, or manufactured reactor; or (B) Reference a standard design certification issued... certification or standard design approval; or (B) Reference a standard design certification issued before July...

10 CFR 50.150 - Aircraft impact assessment.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 13, 2009; (B) Renewal of standard design certifications in effect on July 13, 2009 which have not..., standard design approval, or manufactured reactor; or (B) Reference a standard design certification issued... certification or standard design approval; or (B) Reference a standard design certification issued before July...

10 CFR 50.150 - Aircraft impact assessment.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 13, 2009; (B) Renewal of standard design certifications in effect on July 13, 2009 which have not..., standard design approval, or manufactured reactor; or (B) Reference a standard design certification issued... certification or standard design approval; or (B) Reference a standard design certification issued before July...

10 CFR 50.150 - Aircraft impact assessment.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 13, 2009; (B) Renewal of standard design certifications in effect on July 13, 2009 which have not..., standard design approval, or manufactured reactor; or (B) Reference a standard design certification issued... certification or standard design approval; or (B) Reference a standard design certification issued before July...

[Analysis of methylmercury in biological guano by the optimized atomic fluorescence spectrometry coupled with microwave assisted extraction].

PubMed

Chen, Qian-Qian; Liu, Xiao-Dong; Sun, Li-Guang; Jiang, Shan; Yan, Hong; Liu, Yi; Luo, Yu-Han; Huang, Jing

2011-01-01

The analytical method for the determination of methylmercury in seabird excrements was established using atomic fluorescence spectrometry coupled with microwave-assisted extraction In general, temperature and hydrochloric amount are the most important influencing factors on the extraction of MeHg in the samples, and the present paper optimized these two parameters. The result showed that 120 degrees C and 200 microL 6 mol x L(-1) hydrochloric acid are the best extraction conditions. Under these experimental conditions, the relative standard deviation (RSD) values of reduplicative analyses on standard reference material (human hair powder) and the same seabird excrement sample were 0.74% and 6.61% respectively, and their percent recoveries were over 90%. The combination of microwave-assisted extraction and atomic fluorescence spectrometry has many advantages such as simple operation, high sensitivity, low detection limit and low cost, therefore, it is suitable for rapid separation and analysis of trace methylmercury composition in the biological guanos. Using this method, we analyzed the methylmercury contents in the ancient and fresh seabird droppings taken from Xisha Islands of South China Sea, and the result showed that the Xisha guanos were rich in methylmercury and the large input of seabird guanos will cause serious environmental contamination in the remote island ecosystem of Xisha Islands.

Optical Fiber Power Meter Comparison Between NIST and NIM.

PubMed

Vayshenker, I; Livigni, D J; Li, X; Lehman, J H; Li, J; Xiong, L M; Zhang, Z X

2010-01-01

We describe the results of a comparison of reference standards between the National Institute of Standards and Technology (NIST-USA) and National Institute of Metrology (NIM-China). We report optical fiber-based power measurements at nominal wavelengths of 1310 nm and 1550 nm. We compare the laboratories' reference standards by means of a commercial optical power meter. Measurement results showed the largest difference of less than 2.6 parts in 10(3), which is within the combined standard (k = 1) uncertainty for the laboratories' reference standards.

Physical Habitat and Energy Inputs Determine Freshwater Invertebrate Communities in Reference and Cranberry Farm Impacted Northeastern Coastal Zone Streams

NASA Astrophysics Data System (ADS)

Lander, D. M. P.; McCanty, S. T.; Dimino, T. F.; Christian, A. D.

2016-02-01

The River Continuum Concept (RCC) predicts stream biological communities based on dominant physical structures and energy inputs into streams and predicts how these features and corresponding communities change along the stream continuum. Verifying RCC expectations is important for creating valid points of comparison during stream ecosystem evaluation. These reference expectations are critical for restoration projects, such as the restoration of decommissioned cranberry bogs. Our research compares the physical habitat and freshwater invertebrate functional feeding groups (FWIFFG) of reference, active cranberry farming, and cranberry farm passive restoration sites in Northeastern Coastal Zone streams of Massachusetts to the specific RCC FWIFFG predictions. We characterized stream physical habitat using a semi-quantitative habitat characterization protocol and sampled freshwater invertebrates using the U.S. EPA standard 20-jab multi-habitat protocol. We expected that stream habitat would be most homogeneous at active farming stations, intermediate at restoration stations, and most heterogeneous at reference stations. Furthermore, we expected reference stream FWIFFG would be accurately predicted by the RCC and distributions at restoration and active sites would vary significantly. Habitat data was analyzed using a principle component analysis and results confirmed our predictions showing more homogeneous habitat for the active and reference stations, while showing a more heterogeneous habitat at the reference stations. The FWIFFG chi-squared analysis showed significant deviation from our specific RCC FWIFFG predictions. Because published FWIFFG distributions did not match our empirical values for a least disturbed Northeastern Coastal Zone headwater stream, using our data as a community structure template for current and future restoration projects is not recommend without further considerations.

Direct and Absolute Quantification of over 1800 Yeast Proteins via Selected Reaction Monitoring*

PubMed Central

Lawless, Craig; Holman, Stephen W.; Brownridge, Philip; Lanthaler, Karin; Harman, Victoria M.; Watkins, Rachel; Hammond, Dean E.; Miller, Rebecca L.; Sims, Paul F. G.; Grant, Christopher M.; Eyers, Claire E.; Beynon, Robert J.

2016-01-01

Defining intracellular protein concentration is critical in molecular systems biology. Although strategies for determining relative protein changes are available, defining robust absolute values in copies per cell has proven significantly more challenging. Here we present a reference data set quantifying over 1800 Saccharomyces cerevisiae proteins by direct means using protein-specific stable-isotope labeled internal standards and selected reaction monitoring (SRM) mass spectrometry, far exceeding any previous study. This was achieved by careful design of over 100 QconCAT recombinant proteins as standards, defining 1167 proteins in terms of copies per cell and upper limits on a further 668, with robust CVs routinely less than 20%. The selected reaction monitoring-derived proteome is compared with existing quantitative data sets, highlighting the disparities between methodologies. Coupled with a quantification of the transcriptome by RNA-seq taken from the same cells, these data support revised estimates of several fundamental molecular parameters: a total protein count of ∼100 million molecules-per-cell, a median of ∼1000 proteins-per-transcript, and a linear model of protein translation explaining 70% of the variance in translation rate. This work contributes a “gold-standard” reference yeast proteome (including 532 values based on high quality, dual peptide quantification) that can be widely used in systems models and for other comparative studies. PMID:26750110

DNA Barcoding for Species Identification of Insect Skins: A Test on Chironomidae (Diptera) Pupal Exuviae

PubMed Central

Ekrem, Torbjørn; Stur, Elisabeth

2017-01-01

Abstract Chironomidae (Diptera) pupal exuviae samples are commonly used for biological monitoring of aquatic habitats. DNA barcoding has proved useful for species identification of chironomid life stages containing cellular tissue, but the barcoding success of chironomid pupal exuviae is unknown. We assessed whether standard DNA barcoding could be efficiently used for species identification of chironomid pupal exuviae when compared with morphological techniques and if there were differences in performance between temperate and tropical ecosystems, subfamilies, and tribes. PCR, sequence, and identification success differed significantly between geographic regions and taxonomic groups. For Norway, 27 out of 190 (14.2%) of pupal exuviae resulted in high-quality chironomid sequences that match species. For Costa Rica, 69 out of 190 (36.3%) Costa Rican pupal exuviae resulted in high-quality sequences, but none matched known species. Standard DNA barcoding of chironomid pupal exuviae had limited success in species identification of unknown specimens due to contaminations and lack of matching references in available barcode libraries, especially from Costa Rica. Therefore, we recommend future biodiversity studies that focus their efforts on understudied regions, to simultaneously use morphological and molecular identification techniques to identify all life stages of chironomids and populate the barcode reference library with identified sequences.

Multielemental analysis in small amounts of environmental reference materials with inductively coupled plasma mass spectrometry.

PubMed

Dombovári, J; Becker, J S; Dietze, H J

2000-07-01

The lowest possible sample weight for performing multielemental trace element analysis on environmental and biological samples by ICP-MS has been investigated. The certified reference materials Bovine Liver NIST SRM 1577b, Human Hair NCS DC 73347 and Oriental Tobacco Leaves CTA-OTL-1 were applied at sample weights (1, 5, 20 and 50 mg aliquots, n = 10) which were significantly lower than those recommended with most recoveries in the range of 95-110%. Samples were digested in a mixture of nitric acid, hydrogen peroxide and hydrogen fluoride by closed-vessel microwave digestion. Multielemental analysis was performed with an optimized ICP-QMS method. Aqueous standard solutions were applied for external calibration with rhodium as the internal standard element. The detection limits varied between 0.02-0.38 microg/g for Li, Na, Cr, Mn, Ni, Cu, Zn, Sr, Cd, Ba and Pb, and up to 1.92 microg/g for Mg, Al, Ca, Fe and Ni. Digested human plasma samples were spiked with multielemental solution (0.5-10 microg/L) to test the analytical method and the recoveries were 95-105% for most analytes. Our results show that in the case of homogeneous SRMs it is possible to use them in very low amounts (1-5 mg) for method development and quality control.

Towards a framework for developing semantic relatedness reference standards.

PubMed

Pakhomov, Serguei V S; Pedersen, Ted; McInnes, Bridget; Melton, Genevieve B; Ruggieri, Alexander; Chute, Christopher G

2011-04-01

Our objective is to develop a framework for creating reference standards for functional testing of computerized measures of semantic relatedness. Currently, research on computerized approaches to semantic relatedness between biomedical concepts relies on reference standards created for specific purposes using a variety of methods for their analysis. In most cases, these reference standards are not publicly available and the published information provided in manuscripts that evaluate computerized semantic relatedness measurement approaches is not sufficient to reproduce the results. Our proposed framework is based on the experiences of medical informatics and computational linguistics communities and addresses practical and theoretical issues with creating reference standards for semantic relatedness. We demonstrate the use of the framework on a pilot set of 101 medical term pairs rated for semantic relatedness by 13 medical coding experts. While the reliability of this particular reference standard is in the "moderate" range; we show that using clustering and factor analyses offers a data-driven approach to finding systematic differences among raters and identifying groups of potential outliers. We test two ontology-based measures of relatedness and provide both the reference standard containing individual ratings and the R program used to analyze the ratings as open-source. Currently, these resources are intended to be used to reproduce and compare results of studies involving computerized measures of semantic relatedness. Our framework may be extended to the development of reference standards in other research areas in medical informatics including automatic classification, information retrieval from medical records and vocabulary/ontology development. Copyright © 2010 Elsevier Inc. All rights reserved.

29 CFR 2703.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 9 2011-07-01 2011-07-01 false Cross-reference to employee ethical conduct standards and...-reference to employee ethical conduct standards and financial disclosure regulations. Members and employees... of Ethical Conduct at 5 CFR part 2635; the Commission's regulations at 5 CFR part 8401, which...

45 CFR 706.1 - Cross-references to employee ethical conduct standards, financial disclosure and financial...

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 3 2011-10-01 2011-10-01 false Cross-references to employee ethical conduct... EMPLOYEE RESPONSIBILITIES AND CONDUCT § 706.1 Cross-references to employee ethical conduct standards... States Commission on Civil Rights are subject to the executive branch standards of ethical conduct...

45 CFR 1105.1 - Cross-reference to employee ethical conduct standards and financial disclosure and financial...

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 3 2011-10-01 2011-10-01 false Cross-reference to employee ethical conduct... STANDARDS OF CONDUCT FOR EMPLOYEES § 1105.1 Cross-reference to employee ethical conduct standards and... ethical conduct at 5 CFR part 2635; the executive branch employees responsibilities and conduct...

49 CFR 99.735-1 - Cross-reference to ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false Cross-reference to ethical conduct standards and... Transportation EMPLOYEE RESPONSIBILITIES AND CONDUCT General § 99.735-1 Cross-reference to ethical conduct... the executive branch-wide Standards of Ethical Conduct at 5 CFR part 2635, the Department of...

39 CFR 3000.735-101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 39 Postal Service 1 2011-07-01 2011-07-01 false Cross-reference to employee ethical conduct... employee ethical conduct standards and financial disclosure regulations. Employees of the Postal Regulatory Commission (Commission) are subject and should refer to the executive branch-wide Standards of Ethical...

45 CFR 706.1 - Cross-references to employee ethical conduct standards, financial disclosure and financial...

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Cross-references to employee ethical conduct... EMPLOYEE RESPONSIBILITIES AND CONDUCT § 706.1 Cross-references to employee ethical conduct standards... States Commission on Civil Rights are subject to the executive branch standards of ethical conduct...

45 CFR 1105.1 - Cross-reference to employee ethical conduct standards and financial disclosure and financial...

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Cross-reference to employee ethical conduct... STANDARDS OF CONDUCT FOR EMPLOYEES § 1105.1 Cross-reference to employee ethical conduct standards and... ethical conduct at 5 CFR part 2635; the executive branch employees responsibilities and conduct...

49 CFR 99.735-1 - Cross-reference to ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false Cross-reference to ethical conduct standards and... Transportation EMPLOYEE RESPONSIBILITIES AND CONDUCT General § 99.735-1 Cross-reference to ethical conduct... the executive branch-wide Standards of Ethical Conduct at 5 CFR part 2635, the Department of...

39 CFR 3000.735-101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 39 Postal Service 1 2010-07-01 2010-07-01 false Cross-reference to employee ethical conduct... employee ethical conduct standards and financial disclosure regulations. Employees of the Postal Regulatory Commission (Commission) are subject and should refer to the executive branch-wide Standards of Ethical...

29 CFR 2703.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Cross-reference to employee ethical conduct standards and...-reference to employee ethical conduct standards and financial disclosure regulations. Members and employees... of Ethical Conduct at 5 CFR part 2635; the Commission's regulations at 5 CFR part 8401, which...

29 CFR 2703.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 9 2013-07-01 2013-07-01 false Cross-reference to employee ethical conduct standards and...-reference to employee ethical conduct standards and financial disclosure regulations. Members and employees... of Ethical Conduct at 5 CFR part 2635; the Commission's regulations at 5 CFR part 8401, which...

49 CFR 99.735-1 - Cross-reference to ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false Cross-reference to ethical conduct standards and... Transportation EMPLOYEE RESPONSIBILITIES AND CONDUCT General § 99.735-1 Cross-reference to ethical conduct... the executive branch-wide Standards of Ethical Conduct at 5 CFR part 2635, the Department of...

16 CFR § 1030.101 - Cross-references to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Cross-references to employee ethical conduct...-references to employee ethical conduct standards and financial disclosure regulations. Employees of the Consumer Product Safety Commission are subject to the Standards of Ethical Conduct, 5 CFR part 2635, which...

45 CFR 706.1 - Cross-references to employee ethical conduct standards, financial disclosure and financial...

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 3 2012-10-01 2012-10-01 false Cross-references to employee ethical conduct... EMPLOYEE RESPONSIBILITIES AND CONDUCT § 706.1 Cross-references to employee ethical conduct standards... States Commission on Civil Rights are subject to the executive branch standards of ethical conduct...

49 CFR 99.735-1 - Cross-reference to ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false Cross-reference to ethical conduct standards and... Transportation EMPLOYEE RESPONSIBILITIES AND CONDUCT General § 99.735-1 Cross-reference to ethical conduct... the executive branch-wide Standards of Ethical Conduct at 5 CFR part 2635, the Department of...

45 CFR 1105.1 - Cross-reference to employee ethical conduct standards and financial disclosure and financial...

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 3 2012-10-01 2012-10-01 false Cross-reference to employee ethical conduct... STANDARDS OF CONDUCT FOR EMPLOYEES § 1105.1 Cross-reference to employee ethical conduct standards and... ethical conduct at 5 CFR part 2635; the executive branch employees responsibilities and conduct...

29 CFR 2703.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 9 2014-07-01 2014-07-01 false Cross-reference to employee ethical conduct standards and...-reference to employee ethical conduct standards and financial disclosure regulations. Members and employees... of Ethical Conduct at 5 CFR part 2635; the Commission's regulations at 5 CFR part 8401, which...

39 CFR 3000.735-101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 39 Postal Service 1 2013-07-01 2013-07-01 false Cross-reference to employee ethical conduct... employee ethical conduct standards and financial disclosure regulations. Employees of the Postal Regulatory Commission (Commission) are subject and should refer to the executive branch-wide Standards of Ethical...

39 CFR 3000.735-101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 39 Postal Service 1 2012-07-01 2012-07-01 false Cross-reference to employee ethical conduct... employee ethical conduct standards and financial disclosure regulations. Employees of the Postal Regulatory Commission (Commission) are subject and should refer to the executive branch-wide Standards of Ethical...

45 CFR 1105.1 - Cross-reference to employee ethical conduct standards and financial disclosure and financial...

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 3 2013-10-01 2013-10-01 false Cross-reference to employee ethical conduct... STANDARDS OF CONDUCT FOR EMPLOYEES § 1105.1 Cross-reference to employee ethical conduct standards and... ethical conduct at 5 CFR part 2635; the executive branch employees responsibilities and conduct...

29 CFR 2703.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 9 2012-07-01 2012-07-01 false Cross-reference to employee ethical conduct standards and...-reference to employee ethical conduct standards and financial disclosure regulations. Members and employees... of Ethical Conduct at 5 CFR part 2635; the Commission's regulations at 5 CFR part 8401, which...

45 CFR 1105.1 - Cross-reference to employee ethical conduct standards and financial disclosure and financial...

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 3 2014-10-01 2014-10-01 false Cross-reference to employee ethical conduct... STANDARDS OF CONDUCT FOR EMPLOYEES § 1105.1 Cross-reference to employee ethical conduct standards and... ethical conduct at 5 CFR part 2635; the executive branch employees responsibilities and conduct...

39 CFR 3000.735-101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 39 Postal Service 1 2014-07-01 2014-07-01 false Cross-reference to employee ethical conduct... employee ethical conduct standards and financial disclosure regulations. Employees of the Postal Regulatory Commission (Commission) are subject and should refer to the executive branch-wide Standards of Ethical...

45 CFR 706.1 - Cross-references to employee ethical conduct standards, financial disclosure and financial...

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 3 2013-10-01 2013-10-01 false Cross-references to employee ethical conduct... EMPLOYEE RESPONSIBILITIES AND CONDUCT § 706.1 Cross-references to employee ethical conduct standards... States Commission on Civil Rights are subject to the executive branch standards of ethical conduct...

45 CFR 706.1 - Cross-references to employee ethical conduct standards, financial disclosure and financial...

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 3 2014-10-01 2014-10-01 false Cross-references to employee ethical conduct... EMPLOYEE RESPONSIBILITIES AND CONDUCT § 706.1 Cross-references to employee ethical conduct standards... States Commission on Civil Rights are subject to the executive branch standards of ethical conduct...

49 CFR 99.735-1 - Cross-reference to ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false Cross-reference to ethical conduct standards and... Transportation EMPLOYEE RESPONSIBILITIES AND CONDUCT General § 99.735-1 Cross-reference to ethical conduct... the executive branch-wide Standards of Ethical Conduct at 5 CFR part 2635, the Department of...

SHORT COMMUNICATION: Transportable Zener-diode Voltage Standard

NASA Astrophysics Data System (ADS)

Karpov, O. V.; Shulga, V. M.; Shakirzyanova, F. R.; Sarandi, A. E.

1994-01-01

Five transportable Zener-diode dc voltage standards have been developed, fabricated and investigated at the NPO VNIIFTRI. The standards were designed to transfer the unit of electromotive force (emf) from Josephson reference standards to measuring instruments. Following the results of these investigations, standard N 02 has been used for intercomparison of the Russian Josephson reference standards.

Design and Initial Characterization of the SC-200 Proteomics Standard Mixture

PubMed Central

Bauman, Andrew; Higdon, Roger; Rapson, Sean; Loiue, Brenton; Hogan, Jason; Stacy, Robin; Napuli, Alberto; Guo, Wenjin; van Voorhis, Wesley; Roach, Jared; Lu, Vincent; Landorf, Elizabeth; Stewart, Elizabeth; Kolker, Natali; Collart, Frank; Myler, Peter; van Belle, Gerald

2011-01-01

Abstract High-throughput (HTP) proteomics studies generate large amounts of data. Interpretation of these data requires effective approaches to distinguish noise from biological signal, particularly as instrument and computational capacity increase and studies become more complex. Resolving this issue requires validated and reproducible methods and models, which in turn requires complex experimental and computational standards. The absence of appropriate standards and data sets for validating experimental and computational workflows hinders the development of HTP proteomics methods. Most protein standards are simple mixtures of proteins or peptides, or undercharacterized reference standards in which the identity and concentration of the constituent proteins is unknown. The Seattle Children's 200 (SC-200) proposed proteomics standard mixture is the next step toward developing realistic, fully characterized HTP proteomics standards. The SC-200 exhibits a unique modular design to extend its functionality, and consists of 200 proteins of known identities and molar concentrations from 6 microbial genomes, distributed into 10 molar concentration tiers spanning a 1,000-fold range. We describe the SC-200's design, potential uses, and initial characterization. We identified 84% of SC-200 proteins with an LTQ-Orbitrap and 65% with an LTQ-Velos (false discovery rate = 1% for both). There were obvious trends in success rate, sequence coverage, and spectral counts with protein concentration; however, protein identification, sequence coverage, and spectral counts vary greatly within concentration levels. PMID:21250827

Design and initial characterization of the SC-200 proteomics standard mixture.

PubMed

Bauman, Andrew; Higdon, Roger; Rapson, Sean; Loiue, Brenton; Hogan, Jason; Stacy, Robin; Napuli, Alberto; Guo, Wenjin; van Voorhis, Wesley; Roach, Jared; Lu, Vincent; Landorf, Elizabeth; Stewart, Elizabeth; Kolker, Natali; Collart, Frank; Myler, Peter; van Belle, Gerald; Kolker, Eugene

2011-01-01

High-throughput (HTP) proteomics studies generate large amounts of data. Interpretation of these data requires effective approaches to distinguish noise from biological signal, particularly as instrument and computational capacity increase and studies become more complex. Resolving this issue requires validated and reproducible methods and models, which in turn requires complex experimental and computational standards. The absence of appropriate standards and data sets for validating experimental and computational workflows hinders the development of HTP proteomics methods. Most protein standards are simple mixtures of proteins or peptides, or undercharacterized reference standards in which the identity and concentration of the constituent proteins is unknown. The Seattle Children's 200 (SC-200) proposed proteomics standard mixture is the next step toward developing realistic, fully characterized HTP proteomics standards. The SC-200 exhibits a unique modular design to extend its functionality, and consists of 200 proteins of known identities and molar concentrations from 6 microbial genomes, distributed into 10 molar concentration tiers spanning a 1,000-fold range. We describe the SC-200's design, potential uses, and initial characterization. We identified 84% of SC-200 proteins with an LTQ-Orbitrap and 65% with an LTQ-Velos (false discovery rate = 1% for both). There were obvious trends in success rate, sequence coverage, and spectral counts with protein concentration; however, protein identification, sequence coverage, and spectral counts vary greatly within concentration levels.

77 FR 205 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-55; Small Entity Compliance Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-03

... System. VI Updated Financial 2010-005 Chambers. Accounting Standards Board Accounting References. VII... Financial Accounting Standards Board Accounting References (FAR Case 2010-005) This final rule amends the... authoritative accounting standards owing to the Financial Accounting Standards Board's Accounting Standards...

Reference and Standard Atmosphere Models

NASA Technical Reports Server (NTRS)

Johnson, Dale L.; Roberts, Barry C.; Vaughan, William W.; Parker, Nelson C. (Technical Monitor)

2002-01-01

This paper describes the development of standard and reference atmosphere models along with the history of their origin and use since the mid 19th century. The first "Standard Atmospheres" were established by international agreement in the 1920's. Later some countries, notably the United States, also developed and published "Standard Atmospheres". The term "Reference Atmospheres" is used to identify atmosphere models for specific geographical locations. Range Reference Atmosphere Models developed first during the 1960's are examples of these descriptions of the atmosphere. This paper discusses the various models, scopes, applications and limitations relative to use in aerospace industry activities.

RADIOISOTOPE TECHNIQUES FOR INSTRUCTION IN THE BIOLOGICAL SCIENCES, A LIST OF ANNOTATED REFERENCES.

ERIC Educational Resources Information Center

HURLBURT, EVELYN M.

REFERENCES TO BIOLOGICAL EXPERIMENTS THAT EMPHASIZE THE USE OF RADIOISOTOPES AS TRACERS ARE INCLUDED IN THIS ANNOTATED BIBLIOGRAPHY. MATERIALS INCLUDED ARE CONSIDERED TO BE READILY AVAILABLE AND WERE PUBLISHED AFTER 1960. SECTION I IS COMPOSED OF SELECTED SOURCES. ENTRIES INCLUDE (1) COMPLETE CITATIONS, (2) A BRIEF ANNOTATION, AND (3) LISTS OF…

BioSharing: curated and crowd-sourced metadata standards, databases and data policies in the life sciences.

PubMed

McQuilton, Peter; Gonzalez-Beltran, Alejandra; Rocca-Serra, Philippe; Thurston, Milo; Lister, Allyson; Maguire, Eamonn; Sansone, Susanna-Assunta

2016-01-01

BioSharing (http://www.biosharing.org) is a manually curated, searchable portal of three linked registries. These resources cover standards (terminologies, formats and models, and reporting guidelines), databases, and data policies in the life sciences, broadly encompassing the biological, environmental and biomedical sciences. Launched in 2011 and built by the same core team as the successful MIBBI portal, BioSharing harnesses community curation to collate and cross-reference resources across the life sciences from around the world. BioSharing makes these resources findable and accessible (the core of the FAIR principle). Every record is designed to be interlinked, providing a detailed description not only on the resource itself, but also on its relations with other life science infrastructures. Serving a variety of stakeholders, BioSharing cultivates a growing community, to which it offers diverse benefits. It is a resource for funding bodies and journal publishers to navigate the metadata landscape of the biological sciences; an educational resource for librarians and information advisors; a publicising platform for standard and database developers/curators; and a research tool for bench and computer scientists to plan their work. BioSharing is working with an increasing number of journals and other registries, for example linking standards and databases to training material and tools. Driven by an international Advisory Board, the BioSharing user-base has grown by over 40% (by unique IP address), in the last year thanks to successful engagement with researchers, publishers, librarians, developers and other stakeholders via several routes, including a joint RDA/Force11 working group and a collaboration with the International Society for Biocuration. In this article, we describe BioSharing, with a particular focus on community-led curation.Database URL: https://www.biosharing.org. © The Author(s) 2016. Published by Oxford University Press.

The approval process for biosimilar erythropoiesis-stimulating agents.

PubMed

Wish, Jay B

2014-09-05

A biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is "highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity and potency of the product." The advantage of biosimilar drugs is that they are significantly less expensive than the reference products, allowing for increased accessibility and cost savings. Recognizing these advantages, the US Congress passed the Biologics Price Competition and Innovation Act in 2009 as part of health care reform. The Biologics Price Competition and Innovation Act allows sponsors of biosimilar agents to seek approval by showing structural and functional similarity to the reference agent, with the extent of required clinical studies to be determined on the basis of the degree of biosimilarity with the reference product. The goal is to bring biosimilar agents to the market more efficiently while still protecting the safety of the public. The European Union has had such a process in place for a number of years. Two biosimilar epoetin agents have been approved in the European Union since 2007, and their companies are conducting trials to seek approval in the United States, because Amgen's patent protection for epoetin alfa expires in 2014. Trials completed for European Union approval of both agents showed similar efficacy and safety to the reference epoetin alfa. As with all biologics, immunogenicity concerns may persist because of the fragility of the manufacturing process and the worldwide experience with pure red cell aplasia as a result of epoetin therapy. The uptake of biosimilar epoetins after approval in the United States will depend on the balance of cost advantage against safety concerns. Competition in the marketplace will likely decrease the cost of the reference agent as well. Copyright © 2014 by the American Society of Nephrology.

Aerospace Medicine and Biology: A Continuing Bibliography With Indexes

NASA Technical Reports Server (NTRS)

1997-01-01

This issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes NASA SP-7O11 lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion.

Aerospace Medicine and Biology: A continuing bibliography with indexes, supplement 187

NASA Technical Reports Server (NTRS)

1978-01-01

This supplement to Aerospace Medicine and Biology lists 247 reports, articles and other documents announced during November 1978 in Scientific and Technical Aerospace Reports (STAR) or in International Aerospace Abstracts (IAA). In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which man is subjected during and following simulated or actual flight in the earth's atmosphere or in interplanetary space. References describing similar effects of biological organisms of lower order are also included. Emphasis is placed on applied research, but reference to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the bibliography consists of a bibliographic citation accompanied in most cases by an abstract.

Aerospace Medicine and Biology: A Continuing Bibliography. Supplement 475

NASA Technical Reports Server (NTRS)

1998-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 492

NASA Technical Reports Server (NTRS)

1999-01-01

This report lists reports, articles and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion.

15 CFR 200.104 - Standard reference materials.

Code of Federal Regulations, 2014 CFR

2014-01-01

... the NIST National Measurement Laboratory administers a program to provide many types of well... be readily referred to a common base. NIST SP 260 is a catalog of Standard Reference Materials available from NIST. ...

15 CFR 200.104 - Standard reference materials.

Code of Federal Regulations, 2013 CFR

2013-01-01

... the NIST National Measurement Laboratory administers a program to provide many types of well... be readily referred to a common base. NIST SP 260 is a catalog of Standard Reference Materials available from NIST. ...

15 CFR 200.104 - Standard reference materials.

Code of Federal Regulations, 2011 CFR

2011-01-01

... the NIST National Measurement Laboratory administers a program to provide many types of well... be readily referred to a common base. NIST SP 260 is a catalog of Standard Reference Materials available from NIST. ...

15 CFR 200.104 - Standard reference materials.

Code of Federal Regulations, 2010 CFR

2010-01-01

... the NIST National Measurement Laboratory administers a program to provide many types of well... be readily referred to a common base. NIST SP 260 is a catalog of Standard Reference Materials available from NIST. ...

15 CFR 200.104 - Standard reference materials.

Code of Federal Regulations, 2012 CFR

2012-01-01

... the NIST National Measurement Laboratory administers a program to provide many types of well... be readily referred to a common base. NIST SP 260 is a catalog of Standard Reference Materials available from NIST. ...

Coherent Frequency Reference System for the NASA Deep Space Network

NASA Technical Reports Server (NTRS)

Tucker, Blake C.; Lauf, John E.; Hamell, Robert L.; Gonzaler, Jorge, Jr.; Diener, William A.; Tjoelker, Robert L.

2010-01-01

The NASA Deep Space Network (DSN) requires state-of-the-art frequency references that are derived and distributed from very stable atomic frequency standards. A new Frequency Reference System (FRS) and Frequency Reference Distribution System (FRD) have been developed, which together replace the previous Coherent Reference Generator System (CRG). The FRS and FRD each provide new capabilities that significantly improve operability and reliability. The FRS allows for selection and switching between frequency standards, a flywheel capability (to avoid interruptions when switching frequency standards), and a frequency synthesis system (to generate standardized 5-, 10-, and 100-MHz reference signals). The FRS is powered by redundant, specially filtered, and sustainable power systems and includes a monitor and control capability for station operations to interact and control the frequency-standard selection process. The FRD receives the standardized 5-, 10-, and 100-MHz reference signals and distributes signals to distribution amplifiers in a fan out fashion to dozens of DSN users that require the highly stable reference signals. The FRD is also powered by redundant, specially filtered, and sustainable power systems. The new DSN Frequency Distribution System, which consists of the FRS and FRD systems described here, is central to all operational activities of the NASA DSN. The frequency generation and distribution system provides ultra-stable, coherent, and very low phase-noise references at 5, l0, and 100 MHz to between 60 and 100 separate users at each Deep Space Communications Complex.

12 CFR 336.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Cross-reference to employee ethical conduct... and Conduct § 336.1 Cross-reference to employee ethical conduct standards and financial disclosure... Branch-wide Standards of Ethical Conduct at 5 CFR part 2635, the Corporation regulation at 5 CFR part...

12 CFR 264.101 - Cross-reference to employees' ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 3 2011-01-01 2011-01-01 false Cross-reference to employees' ethical conduct... § 264.101 Cross-reference to employees' ethical conduct standards and financial disclosure regulations... branch-wide standards of ethical conduct at 5 CFR part 2635 and the Board's regulation at 5 CFR part 6801...

10 CFR 1010.102 - Cross-references to employee ethical conduct standards, financial disclosure regulations, and...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Cross-references to employee ethical conduct standards... ENERGY (GENERAL PROVISIONS) CONDUCT OF EMPLOYEES § 1010.102 Cross-references to employee ethical conduct... Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR part 2635, the DOE regulation at...

12 CFR 336.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Cross-reference to employee ethical conduct... and Conduct § 336.1 Cross-reference to employee ethical conduct standards and financial disclosure... Branch-wide Standards of Ethical Conduct at 5 CFR part 2635, the Corporation regulation at 5 CFR part...

12 CFR 264.101 - Cross-reference to employees' ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Cross-reference to employees' ethical conduct... § 264.101 Cross-reference to employees' ethical conduct standards and financial disclosure regulations... branch-wide standards of ethical conduct at 5 CFR part 2635 and the Board's regulation at 5 CFR part 6801...

12 CFR 264.101 - Cross-reference to employees' ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 4 2012-01-01 2012-01-01 false Cross-reference to employees' ethical conduct... AND CONDUCT § 264.101 Cross-reference to employees' ethical conduct standards and financial disclosure... executive branch-wide standards of ethical conduct at 5 CFR part 2635 and the Board's regulation at 5 CFR...

12 CFR 264.101 - Cross-reference to employees' ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 4 2014-01-01 2014-01-01 false Cross-reference to employees' ethical conduct... AND CONDUCT § 264.101 Cross-reference to employees' ethical conduct standards and financial disclosure... executive branch-wide standards of ethical conduct at 5 CFR part 2635 and the Board's regulation at 5 CFR...

12 CFR 336.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Cross-reference to employee ethical conduct... and Conduct § 336.1 Cross-reference to employee ethical conduct standards and financial disclosure... Branch-wide Standards of Ethical Conduct at 5 CFR part 2635, the Corporation regulation at 5 CFR part...

12 CFR 336.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Cross-reference to employee ethical conduct... and Conduct § 336.1 Cross-reference to employee ethical conduct standards and financial disclosure... Branch-wide Standards of Ethical Conduct at 5 CFR part 2635, the Corporation regulation at 5 CFR part...

12 CFR 336.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Cross-reference to employee ethical conduct... and Conduct § 336.1 Cross-reference to employee ethical conduct standards and financial disclosure... Branch-wide Standards of Ethical Conduct at 5 CFR part 2635, the Corporation regulation at 5 CFR part...

12 CFR 264.101 - Cross-reference to employees' ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 4 2013-01-01 2013-01-01 false Cross-reference to employees' ethical conduct... AND CONDUCT § 264.101 Cross-reference to employees' ethical conduct standards and financial disclosure... executive branch-wide standards of ethical conduct at 5 CFR part 2635 and the Board's regulation at 5 CFR...

46 CFR 160.050-1 - Incorporation by reference.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Incorporation by reference. 160.050-1 Section 160.050-1....050-1 Incorporation by reference. (a) Standard. This subpart makes reference to Federal Standard No... Service Center, General Services Administration, Washington, DC 20407. [USCG-1999-6216, 64 FR 53228, Oct...

Calibration-free assays on standard real-time PCR devices

PubMed Central

Debski, Pawel R.; Gewartowski, Kamil; Bajer, Seweryn; Garstecki, Piotr

2017-01-01

Quantitative Polymerase Chain Reaction (qPCR) is one of central techniques in molecular biology and important tool in medical diagnostics. While being a golden standard qPCR techniques depend on reference measurements and are susceptible to large errors caused by even small changes of reaction efficiency or conditions that are typically not marked by decreased precision. Digital PCR (dPCR) technologies should alleviate the need for calibration by providing absolute quantitation using binary (yes/no) signals from partitions provided that the basic assumption of amplification a single target molecule into a positive signal is met. Still, the access to digital techniques is limited because they require new instruments. We show an analog-digital method that can be executed on standard (real-time) qPCR devices. It benefits from real-time readout, providing calibration-free assessment. The method combines advantages of qPCR and dPCR and bypasses their drawbacks. The protocols provide for small simplified partitioning that can be fitted within standard well plate format. We demonstrate that with the use of synergistic assay design standard qPCR devices are capable of absolute quantitation when normal qPCR protocols fail to provide accurate estimates. We list practical recipes how to design assays for required parameters, and how to analyze signals to estimate concentration. PMID:28327545

Calibration-free assays on standard real-time PCR devices

NASA Astrophysics Data System (ADS)

Debski, Pawel R.; Gewartowski, Kamil; Bajer, Seweryn; Garstecki, Piotr

2017-03-01

Quantitative Polymerase Chain Reaction (qPCR) is one of central techniques in molecular biology and important tool in medical diagnostics. While being a golden standard qPCR techniques depend on reference measurements and are susceptible to large errors caused by even small changes of reaction efficiency or conditions that are typically not marked by decreased precision. Digital PCR (dPCR) technologies should alleviate the need for calibration by providing absolute quantitation using binary (yes/no) signals from partitions provided that the basic assumption of amplification a single target molecule into a positive signal is met. Still, the access to digital techniques is limited because they require new instruments. We show an analog-digital method that can be executed on standard (real-time) qPCR devices. It benefits from real-time readout, providing calibration-free assessment. The method combines advantages of qPCR and dPCR and bypasses their drawbacks. The protocols provide for small simplified partitioning that can be fitted within standard well plate format. We demonstrate that with the use of synergistic assay design standard qPCR devices are capable of absolute quantitation when normal qPCR protocols fail to provide accurate estimates. We list practical recipes how to design assays for required parameters, and how to analyze signals to estimate concentration.

Mass Spectrometric Quantification of N-Linked Glycans by Reference to Exogenous Standards.

PubMed

Mehta, Nickita; Porterfield, Mindy; Struwe, Weston B; Heiss, Christian; Azadi, Parastoo; Rudd, Pauline M; Tiemeyer, Michael; Aoki, Kazuhiro

2016-09-02

Environmental and metabolic processes shape the profile of glycoprotein glycans expressed by cells, whether in culture, developing tissues, or mature organisms. Quantitative characterization of glycomic changes associated with these conditions has been achieved historically by reductive coupling of oligosaccharides to various fluorophores following release from glycoprotein and subsequent HPLC or capillary electrophoretic separation. Such labeling-based approaches provide a robust means of quantifying glycan amount based on fluorescence yield. Mass spectrometry, on the other hand, has generally been limited to relative quantification in which the contribution of the signal intensity for an individual glycan is expressed as a percent of the signal intensity summed over the total profile. Relative quantification has been valuable for highlighting changes in glycan expression between samples; sensitivity is high, and structural information can be derived by fragmentation. We have investigated whether MS-based glycomics is amenable to absolute quantification by referencing signal intensities to well-characterized oligosaccharide standards. We report the qualification of a set of N-linked oligosaccharide standards by NMR, HPLC, and MS. We also demonstrate the dynamic range, sensitivity, and recovery from complex biological matrices for these standards in their permethylated form. Our results indicate that absolute quantification for MS-based glycomic analysis is reproducible and robust utilizing currently available glycan standards.

Biological Filters.

ERIC Educational Resources Information Center

Klemetson, S. L.

1978-01-01

Presents the 1978 literature review of wastewater treatment. The review is concerned with biological filters, and it covers: (1) trickling filters; (2) rotating biological contractors; and (3) miscellaneous reactors. A list of 14 references is also presented. (HM)

Controversial Issues within Biology: Enriching Biology Teaching.

ERIC Educational Resources Information Center

Van Rooy, Wilhelmina

2000-01-01

Describes the development and implementation of a senior high school biology lesson concerned with organ transplantation. Discusses the teacher's rationale and techniques for using controversial issues in science teaching. (Contains 18 references.) (Author/WRM)

Mouse Genome Informatics (MGI) Resource: Genetic, Genomic, and Biological Knowledgebase for the Laboratory Mouse.

PubMed

Eppig, Janan T

2017-07-01

The Mouse Genome Informatics (MGI) Resource supports basic, translational, and computational research by providing high-quality, integrated data on the genetics, genomics, and biology of the laboratory mouse. MGI serves a strategic role for the scientific community in facilitating biomedical, experimental, and computational studies investigating the genetics and processes of diseases and enabling the development and testing of new disease models and therapeutic interventions. This review describes the nexus of the body of growing genetic and biological data and the advances in computer technology in the late 1980s, including the World Wide Web, that together launched the beginnings of MGI. MGI develops and maintains a gold-standard resource that reflects the current state of knowledge, provides semantic and contextual data integration that fosters hypothesis testing, continually develops new and improved tools for searching and analysis, and partners with the scientific community to assure research data needs are met. Here we describe one slice of MGI relating to the development of community-wide large-scale mutagenesis and phenotyping projects and introduce ways to access and use these MGI data. References and links to additional MGI aspects are provided. © The Author 2017. Published by Oxford University Press.

Mouse Genome Informatics (MGI) Resource: Genetic, Genomic, and Biological Knowledgebase for the Laboratory Mouse

PubMed Central

Eppig, Janan T.

2017-01-01

Abstract The Mouse Genome Informatics (MGI) Resource supports basic, translational, and computational research by providing high-quality, integrated data on the genetics, genomics, and biology of the laboratory mouse. MGI serves a strategic role for the scientific community in facilitating biomedical, experimental, and computational studies investigating the genetics and processes of diseases and enabling the development and testing of new disease models and therapeutic interventions. This review describes the nexus of the body of growing genetic and biological data and the advances in computer technology in the late 1980s, including the World Wide Web, that together launched the beginnings of MGI. MGI develops and maintains a gold-standard resource that reflects the current state of knowledge, provides semantic and contextual data integration that fosters hypothesis testing, continually develops new and improved tools for searching and analysis, and partners with the scientific community to assure research data needs are met. Here we describe one slice of MGI relating to the development of community-wide large-scale mutagenesis and phenotyping projects and introduce ways to access and use these MGI data. References and links to additional MGI aspects are provided. PMID:28838066

THE FUTURE OF TOXICOLOGY-PREDICTIVE TOXICOLOGY ...

EPA Pesticide Factsheets

A chemistry approach to predictive toxicology relies on structure−activity relationship (SAR) modeling to predict biological activity from chemical structure. Such approaches have proven capabilities when applied to well-defined toxicity end points or regions of chemical space. These approaches are less well-suited, however, to the challenges of global toxicity prediction, i.e., to predicting the potential toxicity of structurally diverse chemicals across a wide range of end points of regulatory and pharmaceutical concern. New approaches that have the potential to significantly improve capabilities in predictive toxicology are elaborating the “activity” portion of the SAR paradigm. Recent advances in two areas of endeavor are particularly promising. Toxicity data informatics relies on standardized data schema, developed for particular areas of toxicological study, to facilitate data integration and enable relational exploration and mining of data across both historical and new areas of toxicological investigation. Bioassay profiling refers to large-scale high-throughput screening approaches that use chemicals as probes to broadly characterize biological response space, extending the concept of chemical “properties” to the biological activity domain. The effective capture and representation of legacy and new toxicity data into mineable form and the large-scale generation of new bioassay data in relation to chemical toxicity, both employing chemical stru

Optical-Fiber Power Meter Comparison Between NIST and PTB.

PubMed

Vayshenker, I; Haars, H; Li, X; Lehman, J H; Livigni, D J

2003-01-01

We describe the results of a comparison of reference standards between the National Institute of Standards and Technology (NIST-USA) and Physikalisch-Technische Bundesanstalt (PTB-Germany) at nominal wavelengths of 1300 nm and 1550 nm using an optical-fiber cable. Both laboratories used thermal detectors as reference standards. A novel temperature-controlled, optical-trap detector was used as a transfer standard to compare two reference standards. Measurement results showed differences of less than 1.5 × 10(-3), which is within the combined uncertainty for both laboratories.

Synthetic biology: evolution or revolution? A co-founder's perspective.

PubMed

Gardner, Timothy S; Hawkins, Kristy

2013-12-01

In this article, we relate the story of Synthetic Biology's birth, from the perspective of a co-founder, and consider its original premise--that standardization and abstraction of biological components will unlock the full potential of biological engineering. The standardization ideas of Synthetic Biology emerged in the late 1990s from a convergence of research on cellular computing, and were motivated by an array of applications from tissue regeneration to bio-sensing to mathematical programming. As the definition of Synthetic Biology has grown to be synonymous with Biological Engineering and Biotechnology, the field has lost sight of the fact that its founding premise has not yet been validated. While the value of standardization has been proven in many other engineering disciplines, none of them involve self-replicating systems. The engineering of self-replicating systems will likely benefit from standardization, and also by embracing the forces of evolution that inexorably shape such systems. Copyright © 2013 Elsevier Ltd. All rights reserved.

Filling reference gaps via assembling DNA barcodes using high-throughput sequencing—moving toward barcoding the world

PubMed Central

Zhou, Chengran

2017-01-01

Abstract Over the past decade, biodiversity researchers have dedicated tremendous efforts to constructing DNA reference barcodes for rapid species registration and identification. Although analytical cost for standard DNA barcoding has been significantly reduced since early 2000, further dramatic reduction in barcoding costs is unlikely because Sanger sequencing is approaching its limits in throughput and chemistry cost. Constraints in barcoding cost not only led to unbalanced barcoding efforts around the globe, but also prevented high-throughput sequencing (HTS)–based taxonomic identification from applying binomial species names, which provide crucial linkages to biological knowledge. We developed an Illumina-based pipeline, HIFI-Barcode, to produce full-length Cytochrome c oxidase subunit I (COI) barcodes from pooled polymerase chain reaction amplicons generated by individual specimens. The new pipeline generated accurate barcode sequences that were comparable to Sanger standards, even for different haplotypes of the same species that were only a few nucleotides different from each other. Additionally, the new pipeline was much more sensitive in recovering amplicons at low quantity. The HIFI-Barcode pipeline successfully recovered barcodes from more than 78% of the polymerase chain reactions that didn’t show clear bands on the electrophoresis gel. Moreover, sequencing results based on the single molecular sequencing platform Pacbio confirmed the accuracy of the HIFI-Barcode results. Altogether, the new pipeline can provide an improved solution to produce full-length reference barcodes at about one-tenth of the current cost, enabling construction of comprehensive barcode libraries for local fauna, leading to a feasible direction for DNA barcoding global biomes. PMID:29077841

Filling reference gaps via assembling DNA barcodes using high-throughput sequencing-moving toward barcoding the world.

PubMed

Liu, Shanlin; Yang, Chentao; Zhou, Chengran; Zhou, Xin

2017-12-01

Over the past decade, biodiversity researchers have dedicated tremendous efforts to constructing DNA reference barcodes for rapid species registration and identification. Although analytical cost for standard DNA barcoding has been significantly reduced since early 2000, further dramatic reduction in barcoding costs is unlikely because Sanger sequencing is approaching its limits in throughput and chemistry cost. Constraints in barcoding cost not only led to unbalanced barcoding efforts around the globe, but also prevented high-throughput sequencing (HTS)-based taxonomic identification from applying binomial species names, which provide crucial linkages to biological knowledge. We developed an Illumina-based pipeline, HIFI-Barcode, to produce full-length Cytochrome c oxidase subunit I (COI) barcodes from pooled polymerase chain reaction amplicons generated by individual specimens. The new pipeline generated accurate barcode sequences that were comparable to Sanger standards, even for different haplotypes of the same species that were only a few nucleotides different from each other. Additionally, the new pipeline was much more sensitive in recovering amplicons at low quantity. The HIFI-Barcode pipeline successfully recovered barcodes from more than 78% of the polymerase chain reactions that didn't show clear bands on the electrophoresis gel. Moreover, sequencing results based on the single molecular sequencing platform Pacbio confirmed the accuracy of the HIFI-Barcode results. Altogether, the new pipeline can provide an improved solution to produce full-length reference barcodes at about one-tenth of the current cost, enabling construction of comprehensive barcode libraries for local fauna, leading to a feasible direction for DNA barcoding global biomes. © The Authors 2017. Published by Oxford University Press.

[Biosimilars--opportunity or threat?].

PubMed

Swierkot, Jerzy

2013-01-01

Strong interest in biosimilars dates back several years. In the coming years the patent protection ends for subsequent biological drugs, including monoclonal antibodies. This paper organizes the most important facts related to the issue of biosimilars. A biosimilar is a biotherapeutic product which is similar in terms of quality, efficacy and safety to an already licensed reference biotherapeutic product'. It should be noted that biosimilars approved underthe current regulations of the European Medicines Agency (EMA) meet the stringent standards of safety, efficacy and immunogenicity. It is also important to realize that the biosimilar has the right to that name, if it is registered by regulatory authorities like EMA or FDA. One should not confuse biosimilar drugs with those which counterfeit or imitate. Clinical trials on the convertibility of innovative and biosimilar drugs are ongoing. Nevertheless,there is no regulatory framework and clear guidelines of conduct in this regard. In the near future, thanks to the registration of the first biosimilar monoclonal antibodies in rheumatology and gastroenterology the availability of biological treatment for patients should increase.

Development of Low-Cost Instrumentation for Single Point Autofluorescence Lifetime Measurements.

PubMed

Lagarto, João; Hares, Jonathan D; Dunsby, Christopher; French, Paul M W

2017-09-01

Autofluorescence lifetime measurements, which can provide label-free readouts in biological tissues, contrasting e.g. different types and states of tissue matrix components and different cellular metabolites, may have significant clinical potential for diagnosis and to provide surgical guidance. However, the cost of the instrumentation typically used currently presents a barrier to wider implementation. We describe a low-cost single point time-resolved autofluorescence instrument, exploiting modulated laser diodes for excitation and FPGA-based circuitry for detection, together with a custom constant fraction discriminator. Its temporal accuracy is compared against a "gold-standard" instrument incorporating commercial TCSPC circuitry by resolving the fluorescence decays of reference fluorophores presenting single and double exponential decay profiles. To illustrate the potential to read out intrinsic contrast in tissue, we present preliminary measurements of autofluorescence lifetime measurements of biological tissues ex vivo. We believe that the lower cost of this instrument could enhance the potential of autofluorescence lifetime metrology for clinical deployment and commercial development.

Biostability analysis for drinking water distribution systems.

PubMed

Srinivasan, Soumya; Harrington, Gregory W

2007-05-01

The ability to limit regrowth in drinking water is referred to as biological stability and depends on the concentration of disinfectant residual and on the concentration of substrate required for the growth of microorganisms. The biostability curve, based on this fundamental concept of biological stability, is a graphical approach to study the two competing effects that determine bacterial regrowth in a distribution system: inactivation due to the presence of a disinfectant, and growth due to the presence of a substrate. Biostability curves are a practical, system specific approach for addressing the problem of bacterial regrowth in distribution systems. This paper presents a standardized algorithm for generating biostability curves and this will enable water utilities to incorporate this approach for their site-specific needs. Using data from pilot scale studies, it was found that this algorithm was applicable to control regrowth of HPC in chlorinated systems where AOC is the growth limiting substrate, and growth of AOB in chloraminated systems, where ammonia is the growth limiting substrate.

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

Marchisio, Mario Andrea, E-mail: marchisio@hit.edu.cn

Published in 2008, Parts & Pools represents one of the first attempts to conceptualize the modular design of bacterial synthetic gene circuits with Standard Biological Parts (DNA segments) and Pools of molecules referred to as common signal carriers (e.g., RNA polymerases and ribosomes). The original framework for modeling bacterial components and designing prokaryotic circuits evolved over the last years and brought, first, to the development of an algorithm for the automatic design of Boolean gene circuits. This is a remarkable achievement since gene digital circuits have a broad range of applications that goes from biosensors for health and environment caremore » to computational devices. More recently, Parts & Pools was enabled to give a proper formal description of eukaryotic biological circuit components. This was possible by employing a rule-based modeling approach, a technique that permits a faithful calculation of all the species and reactions involved in complex systems such as eukaryotic cells and compartments. In this way, Parts & Pools is currently suitable for the visual and modular design of synthetic gene circuits in yeast and mammalian cells too.« less

Plant Reactome: a resource for plant pathways and comparative analysis

PubMed Central

Naithani, Sushma; Preece, Justin; D'Eustachio, Peter; Gupta, Parul; Amarasinghe, Vindhya; Dharmawardhana, Palitha D.; Wu, Guanming; Fabregat, Antonio; Elser, Justin L.; Weiser, Joel; Keays, Maria; Fuentes, Alfonso Munoz-Pomer; Petryszak, Robert; Stein, Lincoln D.; Ware, Doreen; Jaiswal, Pankaj

2017-01-01

Plant Reactome (http://plantreactome.gramene.org/) is a free, open-source, curated plant pathway database portal, provided as part of the Gramene project. The database provides intuitive bioinformatics tools for the visualization, analysis and interpretation of pathway knowledge to support genome annotation, genome analysis, modeling, systems biology, basic research and education. Plant Reactome employs the structural framework of a plant cell to show metabolic, transport, genetic, developmental and signaling pathways. We manually curate molecular details of pathways in these domains for reference species Oryza sativa (rice) supported by published literature and annotation of well-characterized genes. Two hundred twenty-two rice pathways, 1025 reactions associated with 1173 proteins, 907 small molecules and 256 literature references have been curated to date. These reference annotations were used to project pathways for 62 model, crop and evolutionarily significant plant species based on gene homology. Database users can search and browse various components of the database, visualize curated baseline expression of pathway-associated genes provided by the Expression Atlas and upload and analyze their Omics datasets. The database also offers data access via Application Programming Interfaces (APIs) and in various standardized pathway formats, such as SBML and BioPAX. PMID:27799469

New NIST sediment SRM for inorganic analysis.

PubMed

Zeisler, Rolf

2004-03-01

NIST maintains a portfolio of more than 1300 standard reference materials (SRM), more than a third of these relating to measurements in the biological and environmental fields. As part of the continuous renewal and replacement efforts, a set of new marine sediments has been recently developed covering organic and inorganic determinations. This paper describes the steps taken in sample preparation, homogeneity assay, and analytical characterization and certification with specific emphasis on SRM 2702 inorganics in marine sediment. Neutron activation analysis showed the SRM to be highly homogeneous, opening the possibility for use with solid sampling techniques. The certificate provides certified mass fraction values for 25 elements, reference values for eight elements, and information values for 11 elements, covering most of the priority pollutants with small uncertainties of only several percent relative. The values were obtained by combining results from different laboratories and techniques using a Bayesian statistical model. An intercomparison carried out in field laboratories with the material before certification illustrates a high commutability of this SRM.

Correcting sensitivity drift during long-term multi-element signal measurements by solid sampling-ETV-ICP-MS.

PubMed

Martin-Esteban, A; Slowikowski, B; Grobecker, K H

2004-06-17

Solid sampling-electrothermal vaporisation-inductively coupled plasma-mass spectrometry (SS-ETV-ICP-MS) is an attractive technique for the direct simultaneous determination of trace elements in solid samples and especially in long-term studies (i.e. assessment of the homogeneity of reference materials). However, during these studies a downward drift in the instrument sensitivity has been observed due likely to deposits on the sampling and skimmer cones and on the ion lens of the mass spectrometer. Accordingly, in this paper, several means of correcting and/or suppressing sensitivity drift are proposed and evaluated for the monitoring of Cd, Cu, Hg, Mn, Pb, Sb, Se, Sn, Tl, U and V in different reference materials of inorganic and organic (biological) origin. From that studies, the combination of the use of the argon dimer as internal standard together with a modification in the ETV-ICP connection tube seems to be the best mean of getting stable sensitivity during at least 60 consecutive ETV runs.

Systematic identification of human housekeeping genes possibly useful as references in gene expression studies.

PubMed

Caracausi, Maria; Piovesan, Allison; Antonaros, Francesca; Strippoli, Pierluigi; Vitale, Lorenza; Pelleri, Maria Chiara

2017-09-01

The ideal reference, or control, gene for the study of gene expression in a given organism should be expressed at a medium‑high level for easy detection, should be expressed at a constant/stable level throughout different cell types and within the same cell type undergoing different treatments, and should maintain these features through as many different tissues of the organism. From a biological point of view, these theoretical requirements of an ideal reference gene appear to be best suited to housekeeping (HK) genes. Recent advancements in the quality and completeness of human expression microarray data and in their statistical analysis may provide new clues toward the quantitative standardization of human gene expression studies in biology and medicine, both cross‑ and within‑tissue. The systematic approach used by the present study is based on the Transcriptome Mapper tool and exploits the automated reassignment of probes to corresponding genes, intra‑ and inter‑sample normalization, elaboration and representation of gene expression values in linear form within an indexed and searchable database with a graphical interface recording quantitative levels of expression, expression variability and cross‑tissue width of expression for more than 31,000 transcripts. The present study conducted a meta‑analysis of a pool of 646 expression profile data sets from 54 different human tissues and identified actin γ 1 as the HK gene that best fits the combination of all the traditional criteria to be used as a reference gene for general use; two ribosomal protein genes, RPS18 and RPS27, and one aquaporin gene, POM121 transmembrane nucleporin C, were also identified. The present study provided a list of tissue‑ and organ‑specific genes that may be most suited for the following individual tissues/organs: Adipose tissue, bone marrow, brain, heart, kidney, liver, lung, ovary, skeletal muscle and testis; and also provides in these cases a representative, quantitative portrait of the relative, typical gene‑expression profile in the form of searchable database tables.

21 CFR 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic...

Code of Federal Regulations, 2010 CFR

2010-04-01

... requirements for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. (a) The appropriate FDA Center...

Field Demonstration and Validation of a New Device for Measuring Water and Solute Fluxes at CFB Borden

DTIC Science & Technology

2006-11-01

All Quality Control Reference Materials are acquired only from authorized vendors or sources commonly used by U.S. EPA Regional Laboratories...Institue of Standards and Testing (NITS) Standard Reference Materials (SRM) or to the U.S. EPA Reference Standards. Working Standards The commercial...contaminants from clothing or equipment by blowing, shaking or any other means that may disperse material into the air is prohibited. 7.1.3. All disposable

A standard satellite control reference model

NASA Technical Reports Server (NTRS)

Golden, Constance

1994-01-01

This paper describes a Satellite Control Reference Model that provides the basis for an approach to identify where standards would be beneficial in supporting space operations functions. The background and context for the development of the model and the approach are described. A process for using this reference model to trace top level interoperability directives to specific sets of engineering interface standards that must be implemented to meet these directives is discussed. Issues in developing a 'universal' reference model are also identified.

Do changes in biomarkers from space radiation reflect dose or risk?

NASA Astrophysics Data System (ADS)

Brooks, A.

The space environment is made up of many different kinds of radiation so that the proper use of biomarkers is essential to estimate radiation risk. This presentation will evaluate differences between biomarkers of dose and risk and demonstrate why they should not be confused following radiation exposures in deep space. Dose is a physical quantity, while risk is a biological quantity. Many examples exist w ereh dose or changes in biomarkers of dose are inappropriately used as predictors of risk. Without information on the biology of the system, the biomarkers of dose provide little help in predicting risk in tissues or radiation exposure types where no excess risk can be demonstrated. Many of these biomarkers of dose only reflect changes in radiation dose or exposure. However, these markers are often incorrectly used to predict risk. For example, exposure of the trachea or of the deep lung to high-LET alpha particles results in similar changes in the biomarker chromosome damage in these two tissues. Such an observation would predict that the risk for cancer induction would be similar in these two tissues. It has been noted , however, that there has never been a tracheal tumor observed in rats that inhaled radon, but with the same exposure, large numbers of tumors were produced in the deep lung. The biology of the different tissues is the major determinant of the risk rather than the radiation dose. Recognition of this fact has resulted in the generation of tissue weighting factors for use in radiation protection. When tissue weighting factors are used the values derived are still called "dose". It is important to recognize that tissue specific observations have been corrected to reflect risk, and therefore should no longer be viewed as dose. The relative biological effectiveness (RBE) is also used to estimate radiation risk. The use of biomarkers to derive RBE is a difficult since it involves the use of a biological response to a standard low-LET reference radiation. Following low-LET radiation exposure, the biological response often does not increase as a linear function of dose. Thus, the RBE and the subsequent risk predicted is dependent on the dose where the two radiation types are compared. To avoid this problem the standard procedure is to use the dose and dose-rate response and compare the linear components of the two r diation exposures. Important riska comparisons are often done at very low doses, where the reference radiation may either increase or decrease as a function of dose. Since the low-LET exposure often does not produce a significant change above the background level of damage, the derived RBE factors can become very large.Studies using micronuclei as biomarkers following exposure to mono-energetic neutrons, x-rays and gamma rays delivered at very low doses (up to 0.10 Gy) demonstrated the differences in the shape of each dose-response relationship and the problems associated with the RBE. These studies show that RBE may not accurately reflect the hazards or risk associated with space radiation exposure. As additional measures of biological change are developed, it may become possible to base risk on biological change and not on changes in radiation doses. Research funded through grants # DE-FG03-99ER62787 from DOE Office of Biological and Environmental Research and RO1 CA74053-01 from NIH/NASA to Washington State University Tri-Cities.

Boolean Networks in Inference and Dynamic Modeling of Biological Systems at the Molecular and Physiological Level

NASA Astrophysics Data System (ADS)

Thakar, Juilee; Albert, Réka

The following sections are included: * Introduction * Boolean Network Concepts and History * Extensions of the Classical Boolean Framework * Boolean Inference Methods and Examples in Biology * Dynamic Boolean Models: Examples in Plant Biology, Developmental Biology and Immunology * Conclusions * References

A Multicenter Study To Evaluate the Performance of High-Throughput Sequencing for Virus Detection

PubMed Central

Ng, Siemon H. S.; Vandeputte, Olivier; Aljanahi, Aisha; Deyati, Avisek; Cassart, Jean-Pol; Charlebois, Robert L.; Taliaferro, Lanyn P.

2017-01-01

ABSTRACT The capability of high-throughput sequencing (HTS) for detection of known and unknown viruses makes it a powerful tool for broad microbial investigations, such as evaluation of novel cell substrates that may be used for the development of new biological products. However, like any new assay, regulatory applications of HTS need method standardization. Therefore, our three laboratories initiated a study to evaluate performance of HTS for potential detection of viral adventitious agents by spiking model viruses in different cellular matrices to mimic putative materials for manufacturing of biologics. Four model viruses were selected based upon different physical and biochemical properties and commercial availability: human respiratory syncytial virus (RSV), Epstein-Barr virus (EBV), feline leukemia virus (FeLV), and human reovirus (REO). Additionally, porcine circovirus (PCV) was tested by one laboratory. Independent samples were prepared for HTS by spiking intact viruses or extracted viral nucleic acids, singly or mixed, into different HeLa cell matrices (resuspended whole cells, cell lysate, or total cellular RNA). Data were obtained using different sequencing platforms (Roche 454, Illumina HiSeq1500 or HiSeq2500). Bioinformatic analyses were performed independently by each laboratory using available tools, pipelines, and databases. The results showed that comparable virus detection was obtained in the three laboratories regardless of sample processing, library preparation, sequencing platform, and bioinformatic analysis: between 0.1 and 3 viral genome copies per cell were detected for all of the model viruses used. This study highlights the potential for using HTS for sensitive detection of adventitious viruses in complex biological samples containing cellular background. IMPORTANCE Recent high-throughput sequencing (HTS) investigations have resulted in unexpected discoveries of known and novel viruses in a variety of sample types, including research materials, clinical materials, and biological products. Therefore, HTS can be a powerful tool for supplementing current methods for demonstrating the absence of adventitious or unwanted viruses in biological products, particularly when using a new cell line. However, HTS is a complex technology with different platforms, which needs standardization for evaluation of biologics. This collaborative study was undertaken to investigate detection of different virus types using two different HTS platforms. The results of the independently performed studies demonstrated a similar sensitivity of virus detection, regardless of the different sample preparation and processing procedures and bioinformatic analyses done in the three laboratories. Comparable HTS detection of different virus types supports future development of reference virus materials for standardization and validation of different HTS platforms. PMID:28932815

All biology is computational biology.

PubMed

Markowetz, Florian

2017-03-01

Here, I argue that computational thinking and techniques are so central to the quest of understanding life that today all biology is computational biology. Computational biology brings order into our understanding of life, it makes biological concepts rigorous and testable, and it provides a reference map that holds together individual insights. The next modern synthesis in biology will be driven by mathematical, statistical, and computational methods being absorbed into mainstream biological training, turning biology into a quantitative science.

The role of standards in the development and implementation of clinical laboratory tests: a domestic and global perspective.

PubMed

Michaud, Ginette Y

2005-01-01

In the field of clinical laboratory medicine, standardization is aimed at increasing the trueness and reliability of measured values. Standardization relies on the use of written standards, reference measurement procedures and reference materials. These are important tools for the design and validation of new tests, and for establishing the metrological traceability of diagnostic assays. Their use supports the translation of research technologies into new diagnostic assays and leads to more rapid advances in science and medicine, as well as improvements in the quality of patient care. The various standardization tools are described, as are the procedures by which written standards, reference procedures and reference materials are developed. Recent efforts to develop standards for use in the field of molecular diagnostics are discussed. The recognition of standardization tools by the FDA and other regulatory authorities is noted as evidence of their important role in ensuring the safety and performance of in vitro diagnostic devices.

Aerospace Medicine and Biology: A continuing bibliography with indexes, supplement 237

NASA Technical Reports Server (NTRS)

1982-01-01

A bibliography is given on the biological, physiological, psychological, and environmental effects to which man is subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects of biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. In general, emphasis is placed on applied research, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion.

Natural Variation of Drug Susceptibility in Wild-Type Human Immunodeficiency Virus Type 1

PubMed Central

Parkin, N. T.; Hellmann, N. S.; Whitcomb, J. M.; Kiss, L.; Chappey, C.; Petropoulos, C. J.

2004-01-01

Wild-type viruses from the ViroLogic phenotype-genotype database were evaluated to determine the upper confidence limit of the drug susceptibility distributions, or “biological cutoffs,” for the PhenoSense HIV phenotypic drug susceptibility assay. Definition of the natural variation in drug susceptibility in wild-type human immunodeficiency virus (HIV) type 1 isolates is necessary to determine the prevalence of innate drug resistance and to assess the capability of the PhenoSense assay to reliably measure subtle reductions in drug susceptibility. The biological cutoffs for each drug, defined by the 99th percentile of the fold change in the 50% inhibitory concentration distributions or the mean fold change plus 2 standard deviations, were lower than those previously reported for other phenotypic assays and lower than the clinically relevant cutoffs previously defined for the PhenoSense assay. The 99th percentile fold change values ranged from 1.2 (tenofovir) to 1.8 (zidovudine) for nucleoside reverse transcriptase RT inhibitors (RTIs), from 3.0 (efavirenz) to 6.2 (delavirdine) for nonnucleoside RTIs, and from 1.6 (lopinavir) to 3.6 (nelfinavir) for protease inhibitors. To evaluate the potential role of intrinsic assay variability in the observed variations in the drug susceptibilities of wild-type isolates, 10 reference viruses with different drug susceptibility patterns were tested 8 to 30 times each. The median coefficients of variation in fold change for the reference viruses ranged from 12 to 18% for all drugs except zidovudine (32%), strongly suggesting that the observed differences in wild-type virus susceptibility to the different drugs is related to intrinsic virus variability rather than assay variability. The low biological cutoffs and assay variability suggest that the PhenoSense HIV assay may assist in defining clinically relevant susceptibility cutoffs for resistance to antiretroviral drugs. PMID:14742192

Standardization in synthetic biology: an engineering discipline coming of age.

PubMed

Decoene, Thomas; De Paepe, Brecht; Maertens, Jo; Coussement, Pieter; Peters, Gert; De Maeseneire, Sofie L; De Mey, Marjan

2018-08-01

Leaping DNA read-and-write technologies, and extensive automation and miniaturization are radically transforming the field of biological experimentation by providing the tools that enable the cost-effective high-throughput required to address the enormous complexity of biological systems. However, standardization of the synthetic biology workflow has not kept abreast with dwindling technical and resource constraints, leading, for example, to the collection of multi-level and multi-omics large data sets that end up disconnected or remain under- or even unexploited. In this contribution, we critically evaluate the various efforts, and the (limited) success thereof, in order to introduce standards for defining, designing, assembling, characterizing, and sharing synthetic biology parts. The causes for this success or the lack thereof, as well as possible solutions to overcome these, are discussed. Akin to other engineering disciplines, extensive standardization will undoubtedly speed-up and reduce the cost of bioprocess development. In this respect, further implementation of synthetic biology standards will be crucial for the field in order to redeem its promise, i.e. to enable predictable forward engineering.

An Optimized Method for the Measurement of Acetaldehyde by High-Performance Liquid Chromatography

PubMed Central

Guan, Xiangying; Rubin, Emanuel; Anni, Helen

2011-01-01

Background Acetaldehyde is produced during ethanol metabolism predominantly in the liver by alcohol dehydrogenase, and rapidly eliminated by oxidation to acetate via aldehyde dehydrogenase. Assessment of circulating acetaldehyde levels in biological matrices is performed by headspace gas chromatography and reverse phase high-performance liquid chromatography (RP-HPLC). Methods We have developed an optimized method for the measurement of acetaldehyde by RP-HPLC in hepatoma cell culture medium, blood and plasma. After sample deproteinization, acetaldehyde was derivatized with 2,4-dinitrophenylhydrazine (DNPH). The reaction was optimized for pH, amount of derivatization reagent,, time and temperature. Extraction methods of the acetaldehyde-hydrazone (AcH-DPN) stable derivative and product stability studies were carried out. Acetaldehyde was identified by its retention time in comparison to AcH-DPN standard, using a new chromatography gradient program, and quantitated based on external reference standards and standard addition calibration curves in the presence and absence of ethanol. Results Derivatization of acetaldehyde was performed at pH 4.0 with a 80-fold molar excess of DNPH. The reaction was completed in 40 min at ambient temperature, and the product was stable for 2 days. A clear separation of AcH-DNP from DNPH was obtained with a new 11-min chromatography program. Acetaldehyde detection was linear up to 80 μM. The recovery of acetaldehyde was >88% in culture media, and >78% in plasma. We quantitatively determined the ethanol-derived acetaldehyde in hepatoma cells, rat blood and plasma with a detection limit around 3 μM. The accuracy of the method was <9% for intraday and <15% for interday measurements, in small volume (70 μl) plasma sampling. Conclusions An optimized method for the quantitative determination of acetaldehyde in biological systems was developed using derivatization with DNPH, followed by a short RP-HPLC separation of AcH-DNP. The method has an extended linear range, is reproducible and applicable to small volume sampling of culture media and biological fluids. PMID:21895715

Biologic variability of cardiac troponin I in healthy dogs and dogs with different stages of myxomatous mitral valve disease using standard and high-sensitivity immunoassays.

PubMed

Winter, Randolph L; Saunders, Ashley B; Gordon, Sonya G; Miller, Matthew W; Fosgate, Geoffrey T; Suchodolski, Jan S; Steiner, Jörg M

2017-06-01

Biologic variability (BV) is one aspect of interpreting changes in biomarker concentrations known to be clinically important in people with cardiac disease, but it has not been adequately addressed in dogs so far. The purpose of the study was to determine BV of cardiac troponin I (cTnI) in healthy dogs and dogs with 3 stages of myxomatous mitral valve disease (MMVD). Healthy dogs and dogs with 3 stages of MMVD were prospectively assigned to groups based on comprehensive clinical evaluation using current guidelines. Concentrations of cTnI were measured hourly, daily, and weekly using standard and high-sensitivity immunoassays. Within- (CV I ) and between-subject (CV G ) coefficients of variability, percent reference change value (RCV), and index of individuality (IoI) were calculated. All 10 healthy dogs and 76/112 (68%) of samples from 28 MMVD dogs had cTnI concentrations below the limit of detection (LOD) using a standard sensitivity immunoassay. Only 49/160 (31%) of healthy dog samples and no MMVD samples had cTnI below the high-sensitivity immunoassay LOD. Data analysis for the high-sensitivity immunoassay revealed CV I of 48.1%, CV G of 60.1%, RCV of 134.0%, and IoI of 0.804 in healthy dogs. In MMVD dogs, CV I was 39.6%, CV G was 80.7%, RCV was 110%, and IoI was 0.494. Of all MMVD dogs, those with Stage B2 had the lowest RCV of 91%. Biologic variability affects cTnI concentrations in healthy dogs and dogs with MMVD. Consideration of BV may be clinically relevant when monitoring individual changes in cTnI values, using high-sensitivity immunoassays. © 2017 American Society for Veterinary Clinical Pathology.

Multi-agent systems in epidemiology: a first step for computational biology in the study of vector-borne disease transmission.

PubMed

Roche, Benjamin; Guégan, Jean-François; Bousquet, François

2008-10-15

Computational biology is often associated with genetic or genomic studies only. However, thanks to the increase of computational resources, computational models are appreciated as useful tools in many other scientific fields. Such modeling systems are particularly relevant for the study of complex systems, like the epidemiology of emerging infectious diseases. So far, mathematical models remain the main tool for the epidemiological and ecological analysis of infectious diseases, with SIR models could be seen as an implicit standard in epidemiology. Unfortunately, these models are based on differential equations and, therefore, can become very rapidly unmanageable due to the too many parameters which need to be taken into consideration. For instance, in the case of zoonotic and vector-borne diseases in wildlife many different potential host species could be involved in the life-cycle of disease transmission, and SIR models might not be the most suitable tool to truly capture the overall disease circulation within that environment. This limitation underlines the necessity to develop a standard spatial model that can cope with the transmission of disease in realistic ecosystems. Computational biology may prove to be flexible enough to take into account the natural complexity observed in both natural and man-made ecosystems. In this paper, we propose a new computational model to study the transmission of infectious diseases in a spatially explicit context. We developed a multi-agent system model for vector-borne disease transmission in a realistic spatial environment. Here we describe in detail the general behavior of this model that we hope will become a standard reference for the study of vector-borne disease transmission in wildlife. To conclude, we show how this simple model could be easily adapted and modified to be used as a common framework for further research developments in this field.

An optimized method for the measurement of acetaldehyde by high-performance liquid chromatography.

PubMed

Guan, Xiangying; Rubin, Emanuel; Anni, Helen

2012-03-01

Acetaldehyde is produced during ethanol metabolism predominantly in the liver by alcohol dehydrogenase and rapidly eliminated by oxidation to acetate via aldehyde dehydrogenase. Assessment of circulating acetaldehyde levels in biological matrices is performed by headspace gas chromatography and reverse phase high-performance liquid chromatography (RP-HPLC). We have developed an optimized method for the measurement of acetaldehyde by RP-HPLC in hepatoma cell culture medium, blood, and plasma. After sample deproteinization, acetaldehyde was derivatized with 2,4-dinitrophenylhydrazine (DNPH). The reaction was optimized for pH, amount of derivatization reagent, time, and temperature. Extraction methods of the acetaldehyde-hydrazone (AcH-DNP) stable derivative and product stability studies were carried out. Acetaldehyde was identified by its retention time in comparison with AcH-DNP standard, using a new chromatography gradient program, and quantitated based on external reference standards and standard addition calibration curves in the presence and absence of ethanol. Derivatization of acetaldehyde was performed at pH 4.0 with an 80-fold molar excess of DNPH. The reaction was completed in 40 minutes at ambient temperature, and the product was stable for 2 days. A clear separation of AcH-DNP from DNPH was obtained with a new 11-minute chromatography program. Acetaldehyde detection was linear up to 80 μM. The recovery of acetaldehyde was >88% in culture media and >78% in plasma. We quantitatively determined the ethanol-derived acetaldehyde in hepatoma cells, rat blood and plasma with a detection limit around 3 μM. The accuracy of the method was <9% for intraday and <15% for interday measurements, in small volume (70 μl) plasma sampling. An optimized method for the quantitative determination of acetaldehyde in biological systems was developed using derivatization with DNPH, followed by a short RP-HPLC separation of AcH-DNP. The method has an extended linear range, is reproducible and applicable to small-volume sampling of culture media and biological fluids. Copyright © 2011 by the Research Society on Alcoholism.

POTENTIAL RADIOACTIVE POLLUTANTS RESULTING FROM EXPANDED ENERGY PROGRAMS

EPA Science Inventory

An effective environmental monitoring program must have a quality assurance component to assure the production of valid data. Quality assurance has many components: calibration standards, standard reference materials, standard reference methods, interlaboratory comparison studies...

[Preparation of flavonoid reference standards from Scutellariae Radix under the guidance of high performance liquid chromatography-mass spectrometry analysis].

PubMed

Guo, Henan; Yang, Xuedong; Liu, Jun; Zheng, Wenfeng

2012-07-01

Flavonoid reference standards were targeted-prepared from Scutellariae Radix under the guidance of high performance liquid chromatography-mass spectrometry (HPLC-MS) analysis. With HPLC-MS analysis of Scutellariae Radix, 19 flavonoid components were identified by analyzing and comparing their retention times, ultraviolet spectra, and mass spectrometry data with literature. The separation and purification protocols of all targeted flavonoid reference standards were optimally designed according to the results of HPLC-MS analysis and related literature. The ethanol extract of Scutellariae Radix was suspended in water and extracted with petroleum ether, ethyl acetate, and n-butanol successively. The ethyl acetate extract and n-butanol extract were separately subjected to primary separation by low pressure reverse phase preparative chromatography. Then the fractions containing targeted compounds were further purified by low pressure reverse and normal phases preparative chromatography. Finally, baicalin and wogonoside reference standards were obtained from n-butanol extract; baicaelin, wogonin, and oroxylin A reference standards were obtained from ethyl acetate extract. The structures of the 5 reference standards were identified by mass spectrometry (MS) and 1H nuclear magnetic resonance (1H NMR) spectroscopy. The HPLC analytical results showed that the purities of the 5 reference standards were all above 98%. It is demonstrated that the rapid targeted-preparation method under the guidance of the HPLC-MS analysis is applicable for the isolation and preparation of chemical components in traditional Chinese medicines.

Aerospace medicine and biology: A continuing bibliography with indexes, supplement 107, October 1972

NASA Technical Reports Server (NTRS)

1972-01-01

This Supplement of Aerospace Medicine and Biology lists 353 reports, articles, and other documents announced during September 1972 in Scientific and Technical Aerospace Reports or in International Aerospace Abstracts. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which man is subjected during and following simulated or actual flight in the earth's atmosphere or in interplanetary space. References describing similar effects of biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. In general, emphasis is placed on applied research, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion.

Metatranscriptomic analysis of diverse microbial communities reveals core metabolic pathways and microbiome-specific functionality.

PubMed

Jiang, Yue; Xiong, Xuejian; Danska, Jayne; Parkinson, John

2016-01-12

Metatranscriptomics is emerging as a powerful technology for the functional characterization of complex microbial communities (microbiomes). Use of unbiased RNA-sequencing can reveal both the taxonomic composition and active biochemical functions of a complex microbial community. However, the lack of established reference genomes, computational tools and pipelines make analysis and interpretation of these datasets challenging. Systematic studies that compare data across microbiomes are needed to demonstrate the ability of such pipelines to deliver biologically meaningful insights on microbiome function. Here, we apply a standardized analytical pipeline to perform a comparative analysis of metatranscriptomic data from diverse microbial communities derived from mouse large intestine, cow rumen, kimchi culture, deep-sea thermal vent and permafrost. Sequence similarity searches allowed annotation of 19 to 76% of putative messenger RNA (mRNA) reads, with the highest frequency in the kimchi dataset due to its relatively low complexity and availability of closely related reference genomes. Metatranscriptomic datasets exhibited distinct taxonomic and functional signatures. From a metabolic perspective, we identified a common core of enzymes involved in amino acid, energy and nucleotide metabolism and also identified microbiome-specific pathways such as phosphonate metabolism (deep sea) and glycan degradation pathways (cow rumen). Integrating taxonomic and functional annotations within a novel visualization framework revealed the contribution of different taxa to metabolic pathways, allowing the identification of taxa that contribute unique functions. The application of a single, standard pipeline confirms that the rich taxonomic and functional diversity observed across microbiomes is not simply an artefact of different analysis pipelines but instead reflects distinct environmental influences. At the same time, our findings show how microbiome complexity and availability of reference genomes can impact comprehensive annotation of metatranscriptomes. Consequently, beyond the application of standardized pipelines, additional caution must be taken when interpreting their output and performing downstream, microbiome-specific, analyses. The pipeline used in these analyses along with a tutorial has been made freely available for download from our project website: http://www.compsysbio.org/microbiome .

Discovery of C-3 tethered 2-oxo-benzo[1,4]oxazines as potent antioxidants: Bio-inspired based design, synthesis, biological evaluation, cytotoxic and Insilico molecular docking studies

NASA Astrophysics Data System (ADS)

Sharma, Vashundhra; Jaiswal, Pradeep K.; Saran, Mukesh; Yadav, Dharmendra Kumar; Saloni; Mathur, Manas; Swami, Ajit K.; Misra, Sanjeev; Kim, Mi-hyun; Chaudhary, Sandeep

2018-03-01

The discovery of C-3 tethered 2-oxo-benzo[1,4]oxazines as potent antioxidants is disclosed. All the analogues 20a-20ab have been synthesized via “on water” ultrasound-assisted in excellent yields (upto 98%). All the compounds have been evaluated for their in vitro antioxidant activities using DPPH free radical scavenging assay as well as FRAP assay. The result showed promising antioxidant activities having IC50 values in the range of 4.74 ± 0.08 to 92.20 ± 1.54 μg/mL taking ascorbic acid (IC50 = 4.57 μg/mL) as standard reference. In this study, compounds 20b and 20t, the most active compound of the series, showed IC50 values of 6.89 ± 0.07μg/mL and 4.74 ± 0.08 μg/mL, respectively in comparison with ascorbic acid. In addition, the detailed SAR study shows that electron-withdrawing group increases antioxidant activity and vice versa. Furthermore, in the FRAP assay, eight compounds (20c, 20j, 20m, 20n, 20r, 20u, 20z and 20aa) were found more potent than standard reference BHT (C0.5FRAP = 546.0 ± 13.6 μM). The preliminary cytotoxic study reveals the non-toxic nature of active compounds 20b and 20t in non-cancerous 3T3 fibroblast cell lines in MTT assay up to 250 μg/mL concentration. The results were validated via carrying out insilico molecular docking studies of promising compounds 20a, 20b and 20t in comparison with standard reference. To the best of our knowledge, this is the first detailed study of C-3 tethered 2-oxo-benzo[1,4]oxazines as potential antioxidant agents.

The Synthetic Biology Open Language (SBOL) provides a community standard for communicating designs in synthetic biology.

PubMed

Galdzicki, Michal; Clancy, Kevin P; Oberortner, Ernst; Pocock, Matthew; Quinn, Jacqueline Y; Rodriguez, Cesar A; Roehner, Nicholas; Wilson, Mandy L; Adam, Laura; Anderson, J Christopher; Bartley, Bryan A; Beal, Jacob; Chandran, Deepak; Chen, Joanna; Densmore, Douglas; Endy, Drew; Grünberg, Raik; Hallinan, Jennifer; Hillson, Nathan J; Johnson, Jeffrey D; Kuchinsky, Allan; Lux, Matthew; Misirli, Goksel; Peccoud, Jean; Plahar, Hector A; Sirin, Evren; Stan, Guy-Bart; Villalobos, Alan; Wipat, Anil; Gennari, John H; Myers, Chris J; Sauro, Herbert M

2014-06-01

The re-use of previously validated designs is critical to the evolution of synthetic biology from a research discipline to an engineering practice. Here we describe the Synthetic Biology Open Language (SBOL), a proposed data standard for exchanging designs within the synthetic biology community. SBOL represents synthetic biology designs in a community-driven, formalized format for exchange between software tools, research groups and commercial service providers. The SBOL Developers Group has implemented SBOL as an XML/RDF serialization and provides software libraries and specification documentation to help developers implement SBOL in their own software. We describe early successes, including a demonstration of the utility of SBOL for information exchange between several different software tools and repositories from both academic and industrial partners. As a community-driven standard, SBOL will be updated as synthetic biology evolves to provide specific capabilities for different aspects of the synthetic biology workflow.

Toward the First Data Acquisition Standard in Synthetic Biology.

PubMed

Sainz de Murieta, Iñaki; Bultelle, Matthieu; Kitney, Richard I

2016-08-19

This paper describes the development of a new data acquisition standard for synthetic biology. This comprises the creation of a methodology that is designed to capture all the data, metadata, and protocol information associated with biopart characterization experiments. The new standard, called DICOM-SB, is based on the highly successful Digital Imaging and Communications in Medicine (DICOM) standard in medicine. A data model is described which has been specifically developed for synthetic biology. The model is a modular, extensible data model for the experimental process, which can optimize data storage for large amounts of data. DICOM-SB also includes services orientated toward the automatic exchange of data and information between modalities and repositories. DICOM-SB has been developed in the context of systematic design in synthetic biology, which is based on the engineering principles of modularity, standardization, and characterization. The systematic design approach utilizes the design, build, test, and learn design cycle paradigm. DICOM-SB has been designed to be compatible with and complementary to other standards in synthetic biology, including SBOL. In this regard, the software provides effective interoperability. The new standard has been tested by experiments and data exchange between Nanyang Technological University in Singapore and Imperial College London.

18 CFR 3c.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... employee ethical conduct standards and financial disclosure regulations. 3c.1 Section 3c.1 Conservation of... STANDARDS OF CONDUCT § 3c.1 Cross-reference to employee ethical conduct standards and financial disclosure... branch-wide financial disclosure regulations at 5 CFR part 2634, the Standards of Ethical Conduct for...

13 CFR 105.101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... ethical conduct standards and financial disclosure regulations. 105.101 Section 105.101 Business Credit... RESPONSIBILITIES Standards of Conduct § 105.101 Cross-reference to employee ethical conduct standards and financial... to the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR part 2635 and the...

13 CFR 105.101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... ethical conduct standards and financial disclosure regulations. 105.101 Section 105.101 Business Credit... RESPONSIBILITIES Standards of Conduct § 105.101 Cross-reference to employee ethical conduct standards and financial... to the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR part 2635 and the...

18 CFR 3c.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... employee ethical conduct standards and financial disclosure regulations. 3c.1 Section 3c.1 Conservation of... STANDARDS OF CONDUCT § 3c.1 Cross-reference to employee ethical conduct standards and financial disclosure... branch-wide financial disclosure regulations at 5 CFR part 2634, the Standards of Ethical Conduct for...

18 CFR 3c.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... employee ethical conduct standards and financial disclosure regulations. 3c.1 Section 3c.1 Conservation of... STANDARDS OF CONDUCT § 3c.1 Cross-reference to employee ethical conduct standards and financial disclosure... branch-wide financial disclosure regulations at 5 CFR part 2634, the Standards of Ethical Conduct for...

18 CFR 3c.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... employee ethical conduct standards and financial disclosure regulations. 3c.1 Section 3c.1 Conservation of... STANDARDS OF CONDUCT § 3c.1 Cross-reference to employee ethical conduct standards and financial disclosure... branch-wide financial disclosure regulations at 5 CFR part 2634, the Standards of Ethical Conduct for...

18 CFR 3c.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... employee ethical conduct standards and financial disclosure regulations. 3c.1 Section 3c.1 Conservation of... STANDARDS OF CONDUCT § 3c.1 Cross-reference to employee ethical conduct standards and financial disclosure... branch-wide financial disclosure regulations at 5 CFR part 2634, the Standards of Ethical Conduct for...

13 CFR 105.101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... ethical conduct standards and financial disclosure regulations. 105.101 Section 105.101 Business Credit... RESPONSIBILITIES Standards of Conduct § 105.101 Cross-reference to employee ethical conduct standards and financial... to the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR part 2635 and the...

13 CFR 105.101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... ethical conduct standards and financial disclosure regulations. 105.101 Section 105.101 Business Credit... RESPONSIBILITIES Standards of Conduct § 105.101 Cross-reference to employee ethical conduct standards and financial... to the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR part 2635 and the...

13 CFR 105.101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... ethical conduct standards and financial disclosure regulations. 105.101 Section 105.101 Business Credit... RESPONSIBILITIES Standards of Conduct § 105.101 Cross-reference to employee ethical conduct standards and financial... to the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR part 2635 and the...

Biosimilars for Immune-Mediated Chronic Diseases in Primary Care: What a Practicing Physician Needs to Know.

PubMed

Feldman, Steven R; Bagel, Jerry; Namak, Shahla

2018-05-01

The introduction of biologics has revolutionized the treatment of immune-mediated diseases, but high cost and limited patient access remain hurdles, and some physicians are concerned that biosimilars are not similar enough. The purpose of this narrative review is to describe biosimilar safety, efficacy, nomenclature, extrapolation and interchangeability. In the United States, the Biologics Price Competition and Innovation Act created an abbreviated pathway for licensing of a biologic that is biosimilar to another licensed product (i.e., the reference product). This approval pathway differs from that of generic small-molecule drugs because biologics are too complex to be perfectly duplicated, and follows a process designed to demonstrate that any differences between the biosimilar and its reference product have no significant impact on safety and efficacy. The US approval process requires extensive analytical assessments, animal studies and clinical trials, assuring that biosimilar products provide clinical results similar to those of the reference product. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

A Proposal of New Reference System for the Standard Axial, Sagittal, Coronal Planes of Brain Based on the Serially-Sectioned Images

PubMed Central

Park, Jin Seo; Park, Hyo Seok; Shin, Dong Sun; Har, Dong-Hwan; Cho, Zang-Hee; Kim, Young-Bo; Han, Jae-Yong; Chi, Je-Geun

2010-01-01

Sectional anatomy of human brain is useful to examine the diseased brain as well as normal brain. However, intracerebral reference points for the axial, sagittal, and coronal planes of brain have not been standardized in anatomical sections or radiological images. We made 2,343 serially-sectioned images of a cadaver head with 0.1 mm intervals, 0.1 mm pixel size, and 48 bit color and obtained axial, sagittal, and coronal images based on the proposed reference system. This reference system consists of one principal reference point and two ancillary reference points. The two ancillary reference points are the anterior commissure and the posterior commissure. And the principal reference point is the midpoint of two ancillary reference points. It resides in the center of whole brain. From the principal reference point, Cartesian coordinate of x, y, z could be made to be the standard axial, sagittal, and coronal planes. PMID:20052359

12 CFR 400.101 - Cross-reference to employee financial disclosure and ethical conduct standards regulations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... disclosure and ethical conduct standards regulations. 400.101 Section 400.101 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES EMPLOYEE FINANCIAL DISCLOSURE AND ETHICAL CONDUCT STANDARDS REGULATIONS § 400.101 Cross-reference to employee financial disclosure and ethical conduct standards regulations...

36 CFR 811.1 - Cross-references to employees' ethical conduct standards, financial disclosure and financial...

Code of Federal Regulations, 2011 CFR

2011-07-01

...' ethical conduct standards, financial disclosure and financial interests regulations and other conduct... EMPLOYEE RESPONSIBILITIES AND CONDUCT § 811.1 Cross-references to employees' ethical conduct standards... Council on Historic Preservation are subject to the executive branch-wide standards of ethical conduct...

36 CFR 811.1 - Cross-references to employees' ethical conduct standards, financial disclosure and financial...

Code of Federal Regulations, 2010 CFR

2010-07-01

...' ethical conduct standards, financial disclosure and financial interests regulations and other conduct... EMPLOYEE RESPONSIBILITIES AND CONDUCT § 811.1 Cross-references to employees' ethical conduct standards... Council on Historic Preservation are subject to the executive branch-wide standards of ethical conduct...

12 CFR 400.101 - Cross-reference to employee financial disclosure and ethical conduct standards regulations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... disclosure and ethical conduct standards regulations. 400.101 Section 400.101 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES EMPLOYEE FINANCIAL DISCLOSURE AND ETHICAL CONDUCT STANDARDS REGULATIONS § 400.101 Cross-reference to employee financial disclosure and ethical conduct standards regulations...

12 CFR 400.101 - Cross-reference to employee financial disclosure and ethical conduct standards regulations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... disclosure and ethical conduct standards regulations. 400.101 Section 400.101 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES EMPLOYEE FINANCIAL DISCLOSURE AND ETHICAL CONDUCT STANDARDS REGULATIONS § 400.101 Cross-reference to employee financial disclosure and ethical conduct standards regulations...

12 CFR 400.101 - Cross-reference to employee financial disclosure and ethical conduct standards regulations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... disclosure and ethical conduct standards regulations. 400.101 Section 400.101 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES EMPLOYEE FINANCIAL DISCLOSURE AND ETHICAL CONDUCT STANDARDS REGULATIONS § 400.101 Cross-reference to employee financial disclosure and ethical conduct standards regulations...

36 CFR 811.1 - Cross-references to employees' ethical conduct standards, financial disclosure and financial...

Code of Federal Regulations, 2014 CFR

2014-07-01

...' ethical conduct standards, financial disclosure and financial interests regulations and other conduct... EMPLOYEE RESPONSIBILITIES AND CONDUCT § 811.1 Cross-references to employees' ethical conduct standards... Council on Historic Preservation are subject to the executive branch-wide standards of ethical conduct...

12 CFR 400.101 - Cross-reference to employee financial disclosure and ethical conduct standards regulations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... disclosure and ethical conduct standards regulations. 400.101 Section 400.101 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES EMPLOYEE FINANCIAL DISCLOSURE AND ETHICAL CONDUCT STANDARDS REGULATIONS § 400.101 Cross-reference to employee financial disclosure and ethical conduct standards regulations...

36 CFR 811.1 - Cross-references to employees' ethical conduct standards, financial disclosure and financial...

Code of Federal Regulations, 2012 CFR

2012-07-01

...' ethical conduct standards, financial disclosure and financial interests regulations and other conduct... EMPLOYEE RESPONSIBILITIES AND CONDUCT § 811.1 Cross-references to employees' ethical conduct standards... Council on Historic Preservation are subject to the executive branch-wide standards of ethical conduct...

Impacts of biological and procedural factors on semiquantification uptake value of liver in fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography imaging.

PubMed

Mahmud, Mohd Hafizi; Nordin, Abdul Jalil; Ahmad Saad, Fathinul Fikri; Azman, Ahmad Zaid Fattah

2015-10-01

Increased metabolic activity of fluorodeoxyglucose (FDG) in tissue is not only resulting of pathological uptake, but due to physiological uptake as well. This study aimed to determine the impacts of biological and procedural factors on FDG uptake of liver in whole body positron emission tomography/computed tomography (PET/CT) imaging. Whole body fluorine-18 ((18)F) FDG PET/CT scans of 51 oncology patients have been reviewed. Maximum standardized uptake value (SUVmax) of lesion-free liver was quantified in each patient. Pearson correlation was performed to determine the association between the factors of age, body mass index (BMI), blood glucose level, FDG dose and incubation period and liver SUVmax. Multivariate regression analysis was established to determine the significant factors that best predicted the liver SUVmax. Then the subjects were dichotomised into four BMI groups. Analysis of variance (ANOVA) was established for mean difference of SUVmax of liver between those BMI groups. BMI and incubation period were significantly associated with liver SUVmax. These factors were accounted for 29.6% of the liver SUVmax variance. Statistically significant differences were observed in the mean SUVmax of liver among those BMI groups (P<0.05). BMI and incubation period are significant factors affecting physiological FDG uptake of liver. It would be recommended to employ different cut-off value for physiological liver SUVmax as a reference standard for different BMI of patients in PET/CT interpretation and use a standard protocol for incubation period of patient to reduce variation in physiological FDG uptake of liver in PET/CT study.

Biological Soil Crust Web Site

Science.gov Websites

www.soilcrust.org Crust 101 Advanced Gallery References CCERS site Links Biological Soil Crusts Textbook Corrections Level of Development Index Biological soil crusts are the community of organisms , mosses, liverworts and lichens. A Field Guide to Biological Soil Crusts of Western U.S. Drylands: Common

Social Implications of Biological Education.

ERIC Educational Resources Information Center

Grobman, Arnold B.

Political and social implications of biological research, with particular reference to consequences for education, are discussed in this collection of papers presented at the 1969 convention of the National Association of Biology Teachers. Commentary papers by a panel of three, including at least one high school biology teacher and one expert in…

Continuous age- and sex-adjusted reference intervals of urinary markers for cerebral creatine deficiency syndromes: a novel approach to the definition of reference intervals.

PubMed

Mørkrid, Lars; Rowe, Alexander D; Elgstoen, Katja B P; Olesen, Jess H; Ruijter, George; Hall, Patricia L; Tortorelli, Silvia; Schulze, Andreas; Kyriakopoulou, Lianna; Wamelink, Mirjam M C; van de Kamp, Jiddeke M; Salomons, Gajja S; Rinaldo, Piero

2015-05-01

Urinary concentrations of creatine and guanidinoacetic acid divided by creatinine are informative markers for cerebral creatine deficiency syndromes (CDSs). The renal excretion of these substances varies substantially with age and sex, challenging the sensitivity and specificity of postanalytical interpretation. Results from 155 patients with CDS and 12 507 reference individuals were contributed by 5 diagnostic laboratories. They were binned into 104 adjacent age intervals and renormalized with Box-Cox transforms (Ξ). Estimates for central tendency (μ) and dispersion (σ) of Ξ were obtained for each bin. Polynomial regression analysis was used to establish the age dependence of both μ[log(age)] and σ[log(age)]. The regression residuals were then calculated as z-scores = {Ξ - μ[log(age)]}/σ[log(age)]. The process was iterated until all z-scores outside Tukey fences ±3.372 were identified and removed. Continuous percentile charts were then calculated and plotted by retransformation. Statistically significant and biologically relevant subgroups of z-scores were identified. Significantly higher marker values were seen in females than males, necessitating separate reference intervals in both adolescents and adults. Comparison between our reconstructed reference percentiles and current standard age-matched reference intervals highlights an underlying risk of false-positive and false-negative events at certain ages. Disease markers depending strongly on covariates such as age and sex require large numbers of reference individuals to establish peripheral percentiles with sufficient precision. This is feasible only through collaborative data sharing and the use of appropriate statistical methods. Broad application of this approach can be implemented through freely available Web-based software. © 2015 American Association for Clinical Chemistry.

Performance of Commercial Enzyme-Linked Immunosorbent Assays for Detection of Antibodies to Bordetella pertussis▿

PubMed Central

Riffelmann, M.; Thiel, K.; Schmetz, J.; Wirsing von Koenig, C. H.

2010-01-01

Measuring antibodies to Bordetella pertussis antigens is mostly done by enzyme-linked immunosorbent assays (ELISAs). We compared the performance of ELISA kits that were commercially available in Germany. Eleven measured IgG antibodies, and nine measured IgA antibodies. An in-house ELISA with purified antigens served as a reference method. Samples included two WHO reference preparations, the former Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER) reference preparations, serum samples from patients with clinically suspected pertussis, and serum samples from patients having received a combined tetanus, diphtheria, and pertussis (Tdap) vaccination. Kits using pertussis toxin (PT) as an antigen showed linearity compared to the WHO Reference preparation (r2 between 0.82 and 0.99), and these kits could quantify antibodies according to the reference preparation. ELISA kits using mixed antigens showed no linear correlation to the reference preparations. Patient results were compared to results of in-house ELISAs using a dual cutoff of either ≥100 IU/ml anti-PT IgG or ≥40 IU/ml anti-PT IgG together with ≥12 IU/ml anti-PT IgA. The sensitivities of kits measuring IgG antibodies ranged between 0.84 and 1.00. The specificities of kits using PT as an antigen were between 0.81 and 0.93. The specificities of kits using mixed antigens were between 0.51 and 0.59 and were thus not acceptable. The sensitivities of kits measuring IgA antibodies ranged between 0.53 and 0.73, and the specificities were between 0.67 and 0.94, indicating that IgA antibodies may be of limited diagnostic value. Our data suggest that ELISAs should use purified PT as an antigen and be standardized to the 1st International Reference preparation. PMID:20943873

22 CFR 1001.1 - Cross-references to employee ethical conduct standards and financial disclosure regulations.

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2011-04-01

... 22 Foreign Relations 2 2011-04-01 2009-04-01 true Cross-references to employee ethical conduct... FOUNDATION EMPLOYEE RESPONSIBILITIES AND CONDUCT § 1001.1 Cross-references to employee ethical conduct... Foundation should refer to the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR...

15 CFR 230.7 - Description of services and list of fees, incorporation by reference.

Code of Federal Regulations, 2010 CFR

2010-01-01

... STANDARD REFERENCE MATERIALS STANDARD REFERENCE MATERIALS Description of Services and List of Fees § 230.7 Description of services and list of fees, incorporation by reference. (a) The text of NIST Special Publication... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Description of services and list of...

22 CFR 1001.1 - Cross-references to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 2 2010-04-01 2010-04-01 true Cross-references to employee ethical conduct... FOUNDATION EMPLOYEE RESPONSIBILITIES AND CONDUCT § 1001.1 Cross-references to employee ethical conduct... Foundation should refer to the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR...

22 CFR 1001.1 - Cross-references to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 2 2014-04-01 2014-04-01 false Cross-references to employee ethical conduct... FOUNDATION EMPLOYEE RESPONSIBILITIES AND CONDUCT § 1001.1 Cross-references to employee ethical conduct... Foundation should refer to the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR...

22 CFR 1001.1 - Cross-references to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 22 Foreign Relations 2 2013-04-01 2009-04-01 true Cross-references to employee ethical conduct... FOUNDATION EMPLOYEE RESPONSIBILITIES AND CONDUCT § 1001.1 Cross-references to employee ethical conduct... Foundation should refer to the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR...

22 CFR 1001.1 - Cross-references to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 22 Foreign Relations 2 2012-04-01 2009-04-01 true Cross-references to employee ethical conduct... FOUNDATION EMPLOYEE RESPONSIBILITIES AND CONDUCT § 1001.1 Cross-references to employee ethical conduct... Foundation should refer to the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR...

Development of an electrothermal vaporization ICP-MS method and assessment of its applicability to studies of the homogeneity of reference materials.

PubMed

Friese, K C; Grobecker, K H; Wätjen, U

2001-07-01

A method has been developed for measurement of the homogeneity of analyte distribution in powdered materials by use of electrothermal vaporization with inductively coupled plasma mass spectrometric (ETV-ICP-MS) detection. The method enabled the simultaneous determination of As, Cd, Cu, Fe, Mn, Pb, and Zn in milligram amounts of samples of biological origin. The optimized conditions comprised a high plasma power of 1,500 W, reduced aerosol transport flow, and heating ramps below 300 degrees C s(-1). A temperature ramp to 550 degrees C ensured effective pyrolysis of approximately 70% of the organic compounds without losses of analyte. An additional hold stage at 700 degrees C led to separation of most of the analyte signals from the evaporation of carbonaceous matrix compounds. The effect of time resolution of signal acquisition on the precision of the ETV measurements was investigated. An increase in the number of masses monitored up to 20 is possible with not more than 1% additional relative standard deviation of results caused by limited temporal resolution of the transient signals. Recording of signals from the nebulization of aqueous standards in each sample run enabled correction for drift of the sensitivity of the ETV-ICP-MS instrument. The applicability of the developed method to homogeneity studies was assessed by use of four certified reference materials. According to the best repeatability observed in these sample runs, the maximum contribution of the method to the standard deviation is approximately 5% to 6% for all the elements investigated.

A series of strategies for solving the shortage of reference standards for multi-components determination of traditional Chinese medicine, Mahoniae Caulis as a case.

PubMed

Wang, Wenguang; Ma, Xiaoli; Guo, Xiaoyu; Zhao, Mingbo; Tu, Pengfei; Jiang, Yong

2015-09-18

In order to solve the bottleneck of reference standards shortage for comprehensive quality control of traditional Chinese medicines (TCMs), a series of strategies, including one single reference standard to determine multi-compounds (SSDMC), quantitative analysis by standardized reference extract (QASRE), and quantitative nuclear magnetic resonance spectroscopy (qNMR) were proposed, and Mahoniae Caulis was selected as an example to develop and validate these methods for simultaneous determination of four alkaloids, columbamine, jatrorrhizine, palmatine, and berberine. Comprehensive comparisons among these methods and with the conventional external standard method (ESM) were carried out. The relative expanded uncertainty of measurement was firstly used to compare their credibility. The results showed that all these three new developed methods can accurately accomplish the quantification by using only one purified reference standard, but each of them has its own advantages and disadvantages as well as the specific application scope, which were also discussed in detail in this paper. Copyright © 2015 Elsevier B.V. All rights reserved.

Evaluation of the Biolog automated microbial identification system

NASA Technical Reports Server (NTRS)

Klingler, J. M.; Stowe, R. P.; Obenhuber, D. C.; Groves, T. O.; Mishra, S. K.; Pierson, D. L.

1992-01-01

Biolog's identification system was used to identify 39 American Type Culture Collection reference taxa and 45 gram-negative isolates from water samples. Of the reference strains, 98% were identified to genus level and 76% to species level within 4 to 24 h. Identification of some authentic strains of Enterobacter, Klebsiella, and Serratia was unreliable. A total of 93% of the water isolates were identified.

Biological standards for the Knowledge-Based BioEconomy: What is at stake.

PubMed

de Lorenzo, Víctor; Schmidt, Markus

2018-01-25

The contribution of life sciences to the Knowledge-Based Bioeconomy (KBBE) asks for the transition of contemporary, gene-based biotechnology from being a trial-and-error endeavour to becoming an authentic branch of engineering. One requisite to this end is the need for standards to measure and represent accurately biological functions, along with languages for data description and exchange. However, the inherent complexity of biological systems and the lack of quantitative tradition in the field have largely curbed this enterprise. Fortunately, the onset of systems and synthetic biology has emphasized the need for standards not only to manage omics data, but also to increase reproducibility and provide the means of engineering living systems in earnest. Some domains of biotechnology can be easily standardized (e.g. physical composition of DNA sequences, tools for genome editing, languages to encode workflows), while others might be standardized with some dedicated research (e.g. biological metrology, operative systems for bio-programming cells) and finally others will require a considerable effort, e.g. defining the rules that allow functional composition of biological activities. Despite difficulties, these are worthy attempts, as the history of technology shows that those who set/adopt standards gain a competitive advantage over those who do not. Copyright © 2017 Elsevier B.V. All rights reserved.

Four domains: The fundamental unicell and Post-Darwinian Cognition-Based Evolution.

PubMed

Miller, William B; Torday, John S

2018-04-13

Contemporary research supports the viewpoint that self-referential cognition is the proper definition of life. From that initiating platform, a cohesive alternative evolutionary narrative distinct from standard Neodarwinism can be presented. Cognition-Based Evolution contends that biological variation is a product of a self-reinforcing information cycle that derives from self-referential attachment to biological information space-time with its attendant ambiguities. That information cycle is embodied through obligatory linkages among energy, biological information, and communication. Successive reiterations of the information cycle enact the informational architectures of the basic unicellular forms. From that base, inter-domain and cell-cell communications enable genetic and cellular variations through self-referential natural informational engineering and cellular niche construction. Holobionts are the exclusive endpoints of that self-referential cellular engineering as obligatory multicellular combinations of the essential Four Domains: Prokaryota, Archaea, Eukaryota and the Virome. Therefore, it is advocated that these Four Domains represent the perpetual object of the living circumstance rather than the visible macroorganic forms. In consequence, biology and its evolutionary development can be appraised as the continual defense of instantiated cellular self-reference. As the survival of cells is as dependent upon limitations and boundaries as upon any freedom of action, it is proposed that selection represents only one of many forms of cellular constraint that sustain self-referential integrity. Copyright © 2018 Elsevier Ltd. All rights reserved.

Ohio High School Biology Teachers' Views of State Standard for Evolution: Impacts on Practice

ERIC Educational Resources Information Center

Borgerding, Lisa A.

2012-01-01

High school biology teachers face many challenges as they teach evolution. State standards for evolution may provide support for sound evolution instruction. This study attempts to build upon previous work by investigating teachers' views of evolution standards and their evolution practices in a state where evolution standards have been…

Secondary analysis of anthropometric data from a South African national food consumption survey, using different growth reference standards.

PubMed

Bosman, L; Herselman, M G; Kruger, H S; Labadarios, D

2011-11-01

The National Center for Health Statistics (NCHS) references were used to analyse anthropometric data from the 1999 National Food Consumption Survey (NFCS) of South Africa. Since then, however, The Centers for Disease Control and Prevention (CDC) 2000 reference and the World Health Organization (WHO) 2006 standards were released. It was anticipated that these reference and standards may lead to differences in the previous estimates of stunting, wasting, underweight and obesity in the study population. The aim was to compare the anthropometric status of children using the 1977 NCHS, the 2000 CDC growth references and the 2006 WHO standards. All children 12-60 months of age with a complete set of anthropometric data were included in the analyses. Data for 1,512 children were analysed with SAS 9.1 for Windows. A Z-score was calculated for each child for weight-for-age (W/A), weight-for-length/height (W/H), length/height-for-age (H/A) and body mass index (BMI)-for-age, using each of the three reference or standards for comparison. The prevalence of stunting, obesity and overweight were significantly higher and the prevalence of underweight and wasting were lower when using the WHO standards compared to the NCHS and the CDC references. The higher than previously established prevalence of stunting at 20.1% and combined overweight/obesity at 30% poses a challenge to South African policy makers to implement nutrition programmes to decrease the prevalence of both stunting and overweight. The 2006 WHO growth standard should be the standard used for assessment of growth of infants and children younger than 5 years in developing countries.

On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation.

PubMed

Yang, Harry; Novick, Steven; Burdick, Richard K

Analytical similarity is the foundation for demonstration of biosimilarity between a proposed product and a reference product. For this assessment, currently the U.S. Food and Drug Administration (FDA) recommends a tiered system in which quality attributes are categorized into three tiers commensurate with their risk and approaches of varying statistical rigor are subsequently used for the three-tier quality attributes. Key to the analyses of Tiers 1 and 2 quality attributes is the establishment of equivalence acceptance criterion and quality range. For particular licensure applications, the FDA has provided advice on statistical methods for demonstration of analytical similarity. For example, for Tier 1 assessment, an equivalence test can be used based on an equivalence margin of 1.5 σ R , where σ R is the reference product variability estimated by the sample standard deviation S R from a sample of reference lots. The quality range for demonstrating Tier 2 analytical similarity is of the form X̄ R ± K × σ R where the constant K is appropriately justified. To demonstrate Tier 2 analytical similarity, a large percentage (e.g., 90%) of test product must fall in the quality range. In this paper, through both theoretical derivations and simulations, we show that when the reference drug product lots are correlated, the sample standard deviation S R underestimates the true reference product variability σ R As a result, substituting S R for σ R in the Tier 1 equivalence acceptance criterion and the Tier 2 quality range inappropriately reduces the statistical power and the ability to declare analytical similarity. Also explored is the impact of correlation among drug product lots on Type I error rate and power. Three methods based on generalized pivotal quantities are introduced, and their performance is compared against a two-one-sided tests (TOST) approach. Finally, strategies to mitigate risk of correlation among the reference products lots are discussed. A biosimilar is a generic version of the original biological drug product. A key component of a biosimilar development is the demonstration of analytical similarity between the biosimilar and the reference product. Such demonstration relies on application of statistical methods to establish a similarity margin and appropriate test for equivalence between the two products. This paper discusses statistical issues with demonstration of analytical similarity and provides alternate approaches to potentially mitigate these problems. © PDA, Inc. 2016.

Reference field specification and preliminary beam selection strategy for accelerator-based GCR simulation

NASA Astrophysics Data System (ADS)

Slaba, Tony C.; Blattnig, Steve R.; Norbury, John W.; Rusek, Adam; La Tessa, Chiara

2016-02-01

The galactic cosmic ray (GCR) simulator at the NASA Space Radiation Laboratory (NSRL) is intended to deliver the broad spectrum of particles and energies encountered in deep space to biological targets in a controlled laboratory setting. In this work, certain aspects of simulating the GCR environment in the laboratory are discussed. Reference field specification and beam selection strategies at NSRL are the main focus, but the analysis presented herein may be modified for other facilities and possible biological considerations. First, comparisons are made between direct simulation of the external, free space GCR field and simulation of the induced tissue field behind shielding. It is found that upper energy constraints at NSRL limit the ability to simulate the external, free space field directly (i.e. shielding placed in the beam line in front of a biological target and exposed to a free space spectrum). Second, variation in the induced tissue field associated with shielding configuration and solar activity is addressed. It is found that the observed variation is likely within the uncertainty associated with representing any GCR reference field with discrete ion beams in the laboratory, given current facility constraints. A single reference field for deep space missions is subsequently identified. Third, a preliminary approach for selecting beams at NSRL to simulate the designated reference field is presented. This approach is not a final design for the GCR simulator, but rather a single step within a broader design strategy. It is shown that the beam selection methodology is tied directly to the reference environment, allows facility constraints to be incorporated, and may be adjusted to account for additional constraints imposed by biological or animal care considerations. The major biology questions are not addressed herein but are discussed in a companion paper published in the present issue of this journal. Drawbacks of the proposed methodology are discussed and weighed against alternative simulation strategies.

Nutritional situation in the world.

PubMed

Bengoa, J M

1976-03-01

The paper describes the international nutrition problem, with references to previous crisis in the world. It is stated that the present situation cannot be compared to the historical famines in the past. The causes and magnitude of the problem are quite different. The information available on the nutritional situation in the world at present is scanty, erratic and contradictory. The criteria used for such evaluation is not uniform, and this is the reason of the differences in the estimation of the magnitude of the problem. According to the analysis of 101 surveys conducted in 59 developing countries during the last 10 years, in which more than 260,000 children below 5 years were examined the percentage of cases of severe forms of malnutrition was of 2.3% and of moderate forms of 18.8%. However there are some areas where severe forms represent 10 or 20% of children examined. Taking only the most representative surveys (25 out of 59) a rough estimation of the total number of malnoursihed children in developing countries gives the figure of 10 millions of severe forms and 90 millions of moderate forms. The paper makes references to mortality trends in developing countries compared with the trends observed in developed countries. It is the view of the author that the recent dramatic decline on mortality in developing countries is due more to public health action, particularly the existence of new drugs, than to any significant improvement in the standard of living, including nutrition. A distinction is made on the differences between the biological needs of nutrients and the social satisfaction produced by food intake. In fact the biological needs are much less than the average consumption of the affluent society. It is suggested that in order to raise the standards of nutrition in developing countries it would perhaps be necessary to moderate the excessive consumption among other things, of proteins of animal origin in developed countries. Finally the author strongly recommend to intensify the action on nutrition at international, national and family level.

Development of Gold Standard Ion-Selective Electrode-Based Methods for Fluoride Analysis

PubMed Central

Martínez-Mier, E.A.; Cury, J.A.; Heilman, J.R.; Katz, B.P.; Levy, S.M.; Li, Y.; Maguire, A.; Margineda, J.; O’Mullane, D.; Phantumvanit, P.; Soto-Rojas, A.E.; Stookey, G.K.; Villa, A.; Wefel, J.S.; Whelton, H.; Whitford, G.M.; Zero, D.T.; Zhang, W.; Zohouri, V.

2011-01-01

Background/Aims: Currently available techniques for fluoride analysis are not standardized. Therefore, this study was designed to develop standardized methods for analyzing fluoride in biological and nonbiological samples used for dental research. Methods A group of nine laboratories analyzed a set of standardized samples for fluoride concentration using their own methods. The group then reviewed existing analytical techniques for fluoride analysis, identified inconsistencies in the use of these techniques and conducted testing to resolve differences. Based on the results of the testing undertaken to define the best approaches for the analysis, the group developed recommendations for direct and microdiffusion methods using the fluoride ion-selective electrode. Results Initial results demonstrated that there was no consensus regarding the choice of analytical techniques for different types of samples. Although for several types of samples, the results of the fluoride analyses were similar among some laboratories, greater differences were observed for saliva, food and beverage samples. In spite of these initial differences, precise and true values of fluoride concentration, as well as smaller differences between laboratories, were obtained once the standardized methodologies were used. Intraclass correlation coefficients ranged from 0.90 to 0.93, for the analysis of a certified reference material, using the standardized methodologies. Conclusion The results of this study demonstrate that the development and use of standardized protocols for F analysis significantly decreased differences among laboratories and resulted in more precise and true values. PMID:21160184

36 CFR 400.1 - Cross-references to employees' ethical conduct standards, financial disclosure regulations and...

Code of Federal Regulations, 2011 CFR

2011-07-01

...' ethical conduct standards, financial disclosure regulations and other conduct rules. 400.1 Section 400.1... CONDUCT § 400.1 Cross-references to employees' ethical conduct standards, financial disclosure regulations... executive branch-wide standards of ethical conduct and financial disclosure regulations at 5 CFR parts 2634...

24 CFR 0.1 - Cross-reference to employees ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ethical conduct standards and financial disclosure regulations. 0.1 Section 0.1 Housing and Urban... Cross-reference to employees ethical conduct standards and financial disclosure regulations. Employees...-wide standards of ethical conduct at 5 CFR part 2635, the Department's regulation at 5 CFR part 7501...

24 CFR 0.1 - Cross-reference to employees ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ethical conduct standards and financial disclosure regulations. 0.1 Section 0.1 Housing and Urban... Cross-reference to employees ethical conduct standards and financial disclosure regulations. Employees...-wide standards of ethical conduct at 5 CFR part 2635, the Department's regulation at 5 CFR part 7501...

36 CFR 400.1 - Cross-references to employees' ethical conduct standards, financial disclosure regulations and...

Code of Federal Regulations, 2010 CFR

2010-07-01

...' ethical conduct standards, financial disclosure regulations and other conduct rules. 400.1 Section 400.1... CONDUCT § 400.1 Cross-references to employees' ethical conduct standards, financial disclosure regulations... executive branch-wide standards of ethical conduct and financial disclosure regulations at 5 CFR parts 2634...

41 CFR 105-735.1 - Cross-references to employee ethical conduct standards, financial disclosure regulations, and...

Code of Federal Regulations, 2010 CFR

2010-07-01

... employee ethical conduct standards, financial disclosure regulations, and other regulations. 105-735.1... CONDUCT § 105-735.1 Cross-references to employee ethical conduct standards, financial disclosure... executive branch-wide standards of ethical conduct at 5 CFR part 2635, GSA's regulations at 5 CFR part 6701...

29 CFR 1600.101 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 4 2010-07-01 2010-07-01 false Cross-reference to employee ethical conduct standards and... to employee ethical conduct standards and financial disclosure regulations. Employees of the Equal Employment Opportunity Commission (EEOC) are subject to the executive branch-wide Standards of Ethical...

38 CFR 0.735-10 - Cross-reference to employee ethical and other conduct standards and financial disclosure...

Code of Federal Regulations, 2014 CFR

2014-07-01

... employee ethical and other conduct standards and financial disclosure regulations. 0.735-10 Section 0.735... ETHICAL CONDUCT, AND RELATED RESPONSIBILITIES Standards of Ethical Conduct and Related Responsibilities of Employees § 0.735-10 Cross-reference to employee ethical and other conduct standards and financial...

38 CFR 0.735-10 - Cross-reference to employee ethical and other conduct standards and financial disclosure...

Code of Federal Regulations, 2013 CFR

2013-07-01

... employee ethical and other conduct standards and financial disclosure regulations. 0.735-10 Section 0.735... ETHICAL CONDUCT, AND RELATED RESPONSIBILITIES Standards of Ethical Conduct and Related Responsibilities of Employees § 0.735-10 Cross-reference to employee ethical and other conduct standards and financial...

36 CFR 400.1 - Cross-references to employees' ethical conduct standards, financial disclosure regulations and...

Code of Federal Regulations, 2014 CFR

2014-07-01

...' ethical conduct standards, financial disclosure regulations and other conduct rules. 400.1 Section 400.1... CONDUCT § 400.1 Cross-references to employees' ethical conduct standards, financial disclosure regulations... executive branch-wide standards of ethical conduct and financial disclosure regulations at 5 CFR parts 2634...

36 CFR 400.1 - Cross-references to employees' ethical conduct standards, financial disclosure regulations and...

Code of Federal Regulations, 2012 CFR

2012-07-01

...' ethical conduct standards, financial disclosure regulations and other conduct rules. 400.1 Section 400.1... CONDUCT § 400.1 Cross-references to employees' ethical conduct standards, financial disclosure regulations... executive branch-wide standards of ethical conduct and financial disclosure regulations at 5 CFR parts 2634...

24 CFR 0.1 - Cross-reference to employees ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ethical conduct standards and financial disclosure regulations. 0.1 Section 0.1 Housing and Urban... Cross-reference to employees ethical conduct standards and financial disclosure regulations. Employees...-wide standards of ethical conduct at 5 CFR part 2635, the Department's regulation at 5 CFR part 7501...

24 CFR 0.1 - Cross-reference to employees ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ethical conduct standards and financial disclosure regulations. 0.1 Section 0.1 Housing and Urban... Cross-reference to employees ethical conduct standards and financial disclosure regulations. Employees...-wide standards of ethical conduct at 5 CFR part 2635, the Department's regulation at 5 CFR part 7501...

24 CFR 0.1 - Cross-reference to employees ethical conduct standards and financial disclosure regulations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ethical conduct standards and financial disclosure regulations. 0.1 Section 0.1 Housing and Urban... Cross-reference to employees ethical conduct standards and financial disclosure regulations. Employees...-wide standards of ethical conduct at 5 CFR part 2635, the Department's regulation at 5 CFR part 7501...

Gamma-hydroxybutyric acid endogenous production and post-mortem behaviour - the importance of different biological matrices, cut-off reference values, sample collection and storage conditions.

PubMed

Castro, André L; Dias, Mário; Reis, Flávio; Teixeira, Helena M

2014-10-01

Gamma-Hydroxybutyric Acid (GHB) is an endogenous compound with a story of clinical use, since the 1960's. However, due to its secondary effects, it has become a controlled substance, entering the illicit market for recreational and "dance club scene" use, muscle enhancement purposes and drug-facilitated sexual assaults. Its endogenous context can bring some difficulties when interpreting, in a forensic context, the analytical values achieved in biological samples. This manuscript reviewed several crucial aspects related to GHB forensic toxicology evaluation, such as its post-mortem behaviour in biological samples; endogenous production values, whether in in vivo and in post-mortem samples; sampling and storage conditions (including stability tests); and cut-off reference values evaluation for different biological samples, such as whole blood, plasma, serum, urine, saliva, bile, vitreous humour and hair. This revision highlights the need of specific sampling care, storage conditions, and cut-off reference values interpretation in different biological samples, essential for proper practical application in forensic toxicology. Copyright © 2014 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

STANDARD REFERENCE MATERIALS FOR THE POLYMERS INDUSTRY.

PubMed

McDonough, Walter G; Orski, Sara V; Guttman, Charles M; Migler, Kalman D; Beers, Kathryn L

2016-01-01

The National Institute of Standards and Technology (NIST) provides science, industry, and government with a central source of well-characterized materials certified for chemical composition or for some chemical or physical property. These materials are designated Standard Reference Materials ® (SRMs) and are used to calibrate measuring instruments, to evaluate methods and systems, or to produce scientific data that can be referred readily to a common base. In this paper, we discuss the history of polymer based SRMs, their current status, and challenges and opportunities to develop new standards to address industrial measurement challenges.

Polyfluorinated substances in abiotic standard reference materials

EPA Science Inventory

The National Institute of Standards and Technology (NIST) has a wide range of Standard Reference Materials (SRMs) which have values assigned for legacy organic pollutants and toxic elements. Existing SRMs serve as homogenous materials that can be used for method development, meth...

Employment references: defamation law in the clinical laboratory.

PubMed

Parks, D G

1993-01-01

The law of defamation and the risks involved in issuing employment references are discussed. A hypothetical scenario is used to illustrate the legal standards governing the tort of defamation and to apply those standards to employment references. Practical suggestions for a "controlled reference" policy are provided, with the objective of allowing for responsible exchange of employment information and avoiding a defamation lawsuit.

Growth References of Preschool Children Based on the Taiwan Birth Cohort Study and Compared to World Health Organization Growth Standards.

PubMed

Li, Yi-Fan; Lin, Shio-Jean; Lin, Kuan-Chia; Chiang, Tung-Liang

2016-02-01

To develop new growth references for height, weight, and body mass index (BMI) for children aged 0-5 years in the Taiwan Birth Cohort Study (TBCS) and to compare these references with both 1997 Taiwan references and World Health Organization (WHO) standards. Data were obtained from the TBCS of a nationally representative sample of 24,200 children. A total of 18,466 children completed the baseline survey at 6 months of age and three follow-up surveys at 18 months, 3 years, and 5.5 years of age. The modified LMS method was used to construct percentile curves by sex, including length/height for age, weight for age, and BMI for age. TBCS children of both sexes were shorter and lighter at birth compared with 1997 Taiwan references and WHO standards. The growth patterns of TBCS children were close to those of the 1997 Taiwan references after 6 months of age. Compared with WHO standards, however, TBCS children were heavier after 6 months of age. This study has developed TBCS references to monitor the growth of children in Taiwan, whose weight growth patterns differed from those "prescribed" by WHO standards. Copyright © 2016. Published by Elsevier B.V.

The potential of standards-based agriculture biology as an alternative to traditional biology in California

NASA Astrophysics Data System (ADS)

Sellu, George Sahr

Over the past five decades, several waves of educational reform have influenced K-12 science course offerings and classroom instruction in public education. The effectiveness of educational policies has been increasingly measured by standardized tests. The focus on test scores, content standards, and performance standards (which is a product of recent educational policies) has influenced course offerings and the depth and breadth of curriculum coverage (Linn, 2000). For the better part of the last hundred years, vocational education and traditional education have followed two separate tracks in terms of objectives, policies, and values (Hillison, 1996). Educational reform policies have had varying influences on school programs. For example, elective courses such as Career Technical Education (CTE) courses---which are not considered core academic courses---have been negatively influenced by current educational reform. In the past three decades, there has been gradual movement toward merging vocational and traditional education. It has been difficult for policies from both sides to merge because of differences in objectives for both tracks. Traditional courses have been guided by federal policies, such as No Child Left Behind (NCLB) and Common Core State Standards (CCSS) while the Carl D. Perkins Act (Perkins Act) has shaped CTE courses. It appears that several of the requirements of the Perkins Act meet expectations of traditional education policies. However, there is no direct metric for measuring the contribution of CTE courses toward increased achievement in science as measured by standardized tests. As such, CTE courses will continue to lose resources in order to support courses that prepare students for standardized tests. In order to address some of these challenges over the last three decades, agriculture educators have developed integrated science courses as a means for increasing science achievement scores for agriculture education students in K-12 public schools. Thoron & Meyer (2011) suggested that research into the contribution of integrated science courses toward higher test scores yielded mixed results. This finding may have been due in part to the fact that integrated science courses only incorporate select topics into agriculture education courses. In California, however, agriculture educators have developed standards-based courses such as Agriculture Biology (AgBio) that cover the same content standards as core traditional courses such as traditional biology. Students in both AgBio and traditional biology take the same standardized biology test. This is the first time there has been an opportunity for a fair comparison and a uniform metric for an agriscience course such as AgBio to be directly compared to traditional biology. This study will examine whether there are differences between AgBio and traditional biology with regard to standardized test scores in biology. Furthermore, the study examines differences in perception between teachers and students regarding teaching and learning activities associated with higher achievement in science. The findings of the study could provide a basis for presenting AgBio as a potential alternative to traditional biology. The findings of this study suggest that there are no differences between AgBio and traditional biology students with regard to standardized biology test scores. Additionally, the findings indicate that co-curricular activities in AgBio could contribute higher student achievement in biology. However, further research is required to identify specific activities in AgBio that contribute to higher achievement in science.

78 FR 37696 - Federal Acquisition Regulation; Updated Postretirement Benefit (PRB) References

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-21

... that were deleted in the Financial Accounting Standards Board's (FASB's) Accounting Standards Codification (ASC) of Generally Accepted Accounting Principles (GAAP). The references no longer exist in the..., 2012, to replace the obsolete references to paragraphs 110, 112, and 113 of Financial Accounting...

Certification of biological candidates reference materials by neutron activation analysis

NASA Astrophysics Data System (ADS)

Kabanov, Denis V.; Nesterova, Yulia V.; Merkulov, Viktor G.

2018-03-01

The paper gives the results of interlaboratory certification of new biological candidate reference materials by neutron activation analysis recommended by the Institute of Nuclear Chemistry and Technology (Warsaw, Poland). The correctness and accuracy of the applied method was statistically estimated for the determination of trace elements in candidate reference materials. The procedure of irradiation in the reactor thermal fuel assembly without formation of fast neutrons was carried out. It excluded formation of interfering isotopes leading to false results. The concentration of more than 20 elements (e.g., Ba, Br, Ca, Co, Ce, Cr, Cs, Eu, Fe, Hf, La, Lu, Rb, Sb, Sc, Ta, Th, Tb, Yb, U, Zn) in candidate references of tobacco leaves and bottom sediment compared to certified reference materials were determined. It was shown that the average error of the applied method did not exceed 10%.

Efficacy and safety data of subsequent entry biologics pertinent to nephrology practice: a systematic review.

PubMed

Marin, Judith Genevieve; Leung, Marianna; Lo, Clifford; Tsao, Nicole W; Martinusen, Daniel J

2014-01-01

Subsequent entry biologics (SEBs) may soon be a reality in Canadian nephrology practice. Understanding the worldwide experience with these agents will be valuable to Canadian clinicians. To compare the efficacy and safety data between SEBs used in nephrology practice and their reference biologic. Systematic review. Ovid MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects, Cochrane Central Register of Controlled Trials. Adult patients with chronic kidney disease (CKD). Our systematic review follows the process outlined by Cochrane Reviews. For efficacy data, all randomized controlled trials (RCTs), quasi-RCTs and observational trials in nephrology practice were included. For safety data, case series, case reports, review articles in nephrology practice and pharmacovigilance programs were included as well. Only epoetin SEBs trials were published in the literature. Ten studies involving three different epoetin SEBs (epoetin zeta, HX575 and epoetin theta) were included. The mean epoetin dose used did not differ significantly between the SEBs and the reference product. For epoetin zeta and epoetin theta, the mean hemoglobin levels achieved in the studies were similar between the SEBs and the reference epoetin. The HX 575 studies reported a mean absolute change in hemoglobin within the predefined equivalence margin, when compared with the reference biologic. In terms of safety data, 2 cases of pure-red-cell aplasia were linked to the subcutaneous administration of HX 575. Otherwise, the rate of adverse drug reactions was similar when epoetin SEBs were compared with the reference biologic. Our analysis is limited by the paucity of information available on SEB use in nephrology with the exception of epoetin SEBs. Methodological flaw was found in one of the epoetin zeta studies which accounted for 45% of pooled results. Little clinical difference was found between epoetin SEBs and the reference product. Although not deemed clinically important, the financial implication of a possible dose difference between epoetin zeta and reference product should be considered in pharmacoeconomic studies. Ongoing trials are expected to address the risk of pure-red-cell aplasia with HX 575.

Predictive Accuracy of Sweep Frequency Impedance Technology in Identifying Conductive Conditions in Newborns.

PubMed

Aithal, Venkatesh; Kei, Joseph; Driscoll, Carlie; Murakoshi, Michio; Wada, Hiroshi

2018-02-01

Diagnosing conductive conditions in newborns is challenging for both audiologists and otolaryngologists. Although high-frequency tympanometry (HFT), acoustic stapedial reflex tests, and wideband absorbance measures are useful diagnostic tools, there is performance measure variability in their detection of middle ear conditions. Additional diagnostic sensitivity and specificity measures gained through new technology such as sweep frequency impedance (SFI) measures may assist in the diagnosis of middle ear dysfunction in newborns. The purpose of this study was to determine the test performance of SFI to predict the status of the outer and middle ear in newborns against commonly used reference standards. Automated auditory brainstem response (AABR), HFT (1000 Hz), transient evoked otoacoustic emission (TEOAE), distortion product otoacoustic emission (DPOAE), and SFI tests were administered to the study sample. A total of 188 neonates (98 males and 90 females) with a mean gestational age of 39.4 weeks were included in the sample. Mean age at the time of testing was 44.4 hr. Diagnostic accuracy of SFI was assessed in terms of its ability to identify conductive conditions in neonates when compared with nine different reference standards (including four single tests [AABR, HFT, TEOAE, and DPOAE] and five test batteries [HFT + DPOAE, HFT + TEOAE, DPOAE + TEOAE, DPOAE + AABR, and TEOAE + AABR]), using receiver operating characteristic (ROC) analysis and traditional test performance measures such as sensitivity and specificity. The test performance of SFI against the test battery reference standard of HFT + DPOAE and single reference standard of HFT was high with an area under the ROC curve (AROC) of 0.87 and 0.82, respectively. Although the HFT + DPOAE test battery reference standard performed better than the HFT reference standard in predicting middle ear conductive conditions in neonates, the difference in AROC was not significant. Further analysis revealed that the highest sensitivity and specificity for SFI (86% and 88%, respectively) was obtained when compared with the reference standard of HFT + DPOAE. Among the four single reference standards, SFI had the highest sensitivity and specificity (76% and 88%, respectively) when compared against the HFT reference standard. The high test performance of SFI against the HFT and HFT + DPOAE reference standards indicates that the SFI measure has appropriate diagnostic accuracy in detection of conductive conditions in newborns. Hence, the SFI test could be used as adjunct tool to identify conductive conditions in universal newborn hearing screening programs, and can also be used in diagnostic follow-up assessments. American Academy of Audiology

Biology Curriculum Reform in Venezuela.

ERIC Educational Resources Information Center

Rondon, Leonor Mariasole

2001-01-01

Describes science in the Venezuelan school system which reflects on the process of development followed to design and validate the Biology Study Programs (BSP) with the emphasis on the relevance of curricular changes proposed in biological science for secondary education. (Contains 19 references.) (ASK)

Acknowledging tissue donation: Human cadaveric specimens in musculoskeletal research.

PubMed

Winkelmann, Andreas; Heinze, Anne-Kathrin; Hendrix, Sven

2016-01-01

Human cadaveric specimens are an important resource for research, particularly in biomechanical studies, but their use also raises ethical questions and cannot simply be taken for granted. It was asked how much information authors publishing musculoskeletal research actually give about such specimens and about how they were acquired. The aim was to formulate recommendations on how this reporting might be improved. Relevant articles published between 2009 and 2012 in four North American or European journals were scanned for information regarding the characteristics of the human specimens used, their institutional source and the ethical or legal context of their acquisition. While the majority of articles report biological characteristics of specimens (sex, age at death, preservation method), only 40% of articles refer to body donation, only 23% report the institution that provided specimens, and only 17% refer to some kind of formalized approval of their research. There were regional and journal-to-journal differences. No standard for reporting studies involving human specimens could be detected. It is suggested that such a standard be developed by researchers and editors. Information on the source of specimens and on the ethical or legal basis should be regularly reported to acknowledge this unique research resource and to preserve the good relationship between researchers and the communities, that provide the required specimens by body donation and upon which researchers depend. © 2015 Wiley Periodicals, Inc.

Quantification of methionine and selenomethionine in biological samples using multiple reaction monitoring high performance liquid chromatography tandem mass spectrometry (MRM-HPLC-MS/MS).

PubMed

Vu, Dai Long; Ranglová, Karolína; Hájek, Jan; Hrouzek, Pavel

2018-05-01

Quantification of selenated amino-acids currently relies on methods employing inductively coupled plasma mass spectrometry (ICP-MS). Although very accurate, these methods do not allow the simultaneous determination of standard amino-acids, hampering the comparison of the content of selenated versus non-selenated species such as methionine (Met) and selenomethionine (SeMet). This paper reports two approaches for the simultaneous quantification of Met and SeMet. In the first approach, standard enzymatic hydrolysis employing Protease XIV was applied for the preparation of samples. The second approach utilized methanesulfonic acid (MA) for the hydrolysis of samples, either in a reflux system or in a microwave oven, followed by derivatization with diethyl ethoxymethylenemalonate. The prepared samples were then analyzed by multiple reaction monitoring high performance liquid chromatography tandem mass spectrometry (MRM-HPLC-MS/MS). Both approaches provided platforms for the accurate determination of selenium/sulfur substitution rate in Met. Moreover the second approach also provided accurate simultaneous quantification of Met and SeMet with a low limit of detection, low limit of quantification and wide linearity range, comparable to the commonly used gas chromatography mass spectrometry (GC-MS) method or ICP-MS. The novel method was validated using certified reference material in conjunction with the GC-MS reference method. Copyright © 2018. Published by Elsevier B.V.

Threats to Biodiversity.

ERIC Educational Resources Information Center

Wilson, Edward O.

1989-01-01

Discusses the extinction of biological wealth due to deforestation. Describes the historical trend of biological diversity and the importance of tropical forests. Lists five references for further reading. (YP)

An Annotated List of Disciplines and Sub-Disciplines in the Biological Sciences

ERIC Educational Resources Information Center

McDonald, Brandon

2008-01-01

Biology has become a large and diversified science. Current biological research areas transgress academic and professional boundaries to such a degree that the biological sciences could arguably be referred to as "all encompassing." In this article, the author describes how he compiled information on currently recognised disciplines and…

Progress with infliximab biosimilars for inflammatory bowel disease.

PubMed

Kurti, Zsuzsanna; Gonczi, Lorant; Lakatos, Peter L

2018-04-29

Biological therapies have revolutionized the treatment of inflammatory bowel diseases (IBD) in the last two decades. Though biological drugs are effective, their use is associated with high costs and access to biological agents varies among countries. As the patent for the reference products expired, the advent of biosimilar monoclonal antibodies has been expected. Biosimilars represent less expensive alternatives compared to the reference product. Areas covered: In this review, authors will review the literature on the clinical efficacy, safety and immunogenicity of current and future biosimilar infliximabs. Short- and medium-term data from real-life cohorts and from randomized-clinical trials in IBD demonstrated similar outcomes in terms of efficacy, safety and immunogenicity as the reference product for CT-P13. Switch data from the reference to the biosimilar product are also accumulating (including the NOR-SWITCH and the CT-P13 3.4 study). Expert opinion: The use of biosimilar infliximab in IBD is increasing worldwide. Its use may be associated with budget savings leading to better access to biological therapies and consequently improved health outcomes. Switching from the originator to a biosimilar in patients with IBD is acceptable, although scientific and clinical evidence is lacking regarding reverse switching, multiple switching, and cross-switching among biosimilars in IBD patients.

Collaborative study for the standardisation of the histamine sensitizing test in mice and the CHO cell-based assay for the residual toxicity testing of acellular pertussis vaccines.

PubMed

Xing, D; Maes, A; Behr-Gross, M-E; Costanzo, A; Daas, A; Buchheit, K-H

2010-04-01

The European Pharmacopoeia (Ph. Eur.) and the World Health Organisation (WHO) require the performance of extensive quality and safety control testing before the release on the market of vaccine products for human use. Safety testing with regard to residual pertussis toxin (PT) in acellular pertussis combination vaccines is performed through assessment of fatal sensitisation of mice to histamine challenge by the vaccine product under test. Currently, use of different in-house procedures and no requirement for the inclusion of a standard reference in each assay render comparisons of results obtained for identical vaccine batches between different control laboratories very difficult. At the initiative of the European Directorate for the Quality of Medicines and HealthCare (EDQM), an international collaborative study was organised for the standardization of the Histamine Sensitizing Test (HIST) in mice and the Chinese Hamster Ovary (CHO)-cell-based assay (performed at the bulk product level) for the residual toxicity testing of acellular pertussis vaccines or acellular pertussis-based combination vaccines. The study was run under the aegis of the Biological Standardisation Programme, jointly supported by the Council of Europe and the European Commission under the project code BSP076. Ten (10) laboratories participated in the study and were requested to perform 3 independent Histamine Sensitizing Tests in mice and to report results of the lethal end-point measurement as prescribed by the Ph. Eur. monographs. Some of them also reported data from an in-house validated CHO-cell-based assay. In addition, some of the laboratories reported concomitantly data obtained by measurement of the drop in temperature induced after the histamine challenge, a method currently under investigation to be added as an alternative end-point for the HIST in the Ph. Eur. monographs for acellular pertussis-based combination vaccines in order to alleviate animal suffering (in application of the 3Rs principle). Based on the results of the collaborative study, a potency of 7500 IU/vial (International Units per vial) was assigned to the current Ph. Eur. Biological Reference Preparation (BRP) for PT. The results of the study also show that 1) intra- and inter-laboratory variations can be improved by the use of a validated standard operating procedure; 2) inclusion in each assay of a standard reference sample, calibrated in IU, can increase comparability of results among laboratories and thus help to reduce repeat testing; 3) a correlation between mortality data and temperature data was observed although, due to the limited number of data sets and the lack of a common method for the temperature end-point, further investigation of this point is required; 4) the CHO-cell-based assay did not yield comparable results and further standardisation of the assay procedure may be investigated in a follow-up project.

Process of prototyping coronary stents from biodegradable Fe-Mn alloys.

PubMed

Hermawan, Hendra; Mantovani, Diego

2013-11-01

Biodegradable stents are considered to be a recent innovation, and their feasibility and applicability have been proven in recent years. Research in this area has focused on materials development and biological studies, rather than on how to transform the developed biodegradable materials into the stent itself. Currently available stent technology, the laser cutting-based process, might be adapted to fabricate biodegradable stents. In this work, the fabrication, characterization and testing of biodegradable Fe-Mn stents are described. A standard process for fabricating and testing stainless steel 316L stents was referred to. The influence of process parameters on the physical, metallurgical and mechanical properties of the stents, and the quality of the produced stents, were investigated. It was found that some steps of the standard process such as laser cutting can be directly applied, but changes to parameters are needed for annealing, and alternatives are needed to replace electropolishing. Copyright © 2013 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Incorporating Earth Science into Other High School Science Classes

NASA Astrophysics Data System (ADS)

Manning, C. L. B.; Holzer, M.; Colson, M.; Courtier, A. M. B.; Jacobs, B. E.

2016-12-01

As states begin to review their standards, some adopt or adapt the NGSS and others write their own, many basing these on the Framework for K-12 Science Education. Both the NGSS and the Frameworks have an increased emphasis on Earth Science but many high school teachers are being asked to teach these standards in traditional Biology, Chemistry and Physics courses. At the Earth Educators Rendezvous, teachers, scientists, and science education researchers worked together to find the interconnections between the sciences using the NGSS and identified ways to reference the role of Earth Sciences in the other sciences during lectures, activities and laboratory assignments. Weaving Earth and Space sciences into the other curricular areas, the teams developed relevant problems for students to solve by focusing on using current issues, media stories, and community issues. These and other lessons and units of study will be presented along with other resources used by teachers to ensure students are gaining exposure and a deeper understanding of Earth and Space Science concepts.

Characteristic of leachate at Alor Pongsu Landfill Site, Perak, Malaysia: A comparative study

NASA Astrophysics Data System (ADS)

Nor Farhana Zakaria, Siti; Aziz, Hamidi Abdul

2018-04-01

Leachate is a harmful by product generated from the landfill site. Leachate contains a high concentration of pollutant which can cause serious pollution to environmental. In this study, characteristics of leachate in Alor Pongsu Landfill Site (APLS) were monitored and analyzed according to the Standard Methods for the Examination of Water and Wastewater (2005). Composition in leachate at APLS was monitored for one year starting from January 2015 until January 2016. Nine parameters were monitored including color, chemical oxygen demand (COD), biological oxygen demand (BOD5), ammoniacal nitrogen (NH3-N), biodegradability ratio (BOD5/COD), temperature, dissolved oxygen (DO), total dissolved solid (TDS) and pH. Based on the analysis, Alor Pongsu Landfill leachate was categorized as stabilized landfill leachate by referring to the BOD5/COD < 0.1. Comparison with allowable discharge limits for leachate shows that most of parameters exceeded the standard discharge limitation. Thus, proper treatment is needed before leachate can be discharged to the environment.

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...

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...

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...

[The requirements of standard and conditions of interchangeability of medical articles].

PubMed

Men'shikov, V V; Lukicheva, T I

2013-11-01

The article deals with possibility to apply specific approaches under evaluation of interchangeability of medical articles for laboratory analysis. The development of standardized analytical technologies of laboratory medicine and formulation of requirements of standards addressed to manufacturers of medical articles the clinically validated requirements are to be followed. These requirements include sensitivity and specificity of techniques, accuracy and precision of research results, stability of reagents' quality in particular conditions of their transportation and storage. The validity of requirements formulated in standards and addressed to manufacturers of medical articles can be proved using reference system, which includes master forms and standard samples, reference techniques and reference laboratories. This approach is supported by data of evaluation of testing systems for measurement of level of thyrotrophic hormone, thyroid hormones and glycated hemoglobin HB A1c. The versions of testing systems can be considered as interchangeable only in case of results corresponding to the results of reference technique and comparable with them. In case of absence of functioning reference system the possibilities of the Joined committee of traceability in laboratory medicine make it possible for manufacturers of reagent sets to apply the certified reference materials under development of manufacturing of sets for large listing of analytes.

Evaluation of reference genes for insect olfaction studies.

PubMed

Omondi, Bonaventure Aman; Latorre-Estivalis, Jose Manuel; Rocha Oliveira, Ivana Helena; Ignell, Rickard; Lorenzo, Marcelo Gustavo

2015-04-22

Quantitative reverse transcription PCR (qRT-PCR) is a robust and accessible method to assay gene expression and to infer gene regulation. Being a chain of procedures, this technique is subject to systematic error due to biological and technical limitations mainly set by the starting material and downstream procedures. Thus, rigorous data normalization is critical to grant reliability and repeatability of gene expression quantification by qRT-PCR. A number of 'housekeeping genes', involved in basic cellular functions, have been commonly used as internal controls for this normalization process. However, these genes could themselves be regulated and must therefore be tested a priori. We evaluated eight potential reference genes for their stability as internal controls for RT-qPCR studies of olfactory gene expression in the antennae of Rhodnius prolixus, a Chagas disease vector. The set of genes included were: α-tubulin; β-actin; Glyceraldehyde-3-phosphate dehydrogenase; Eukaryotic initiation factor 1A; Glutathione-S-transferase; Serine protease; Succinate dehydrogenase; and Glucose-6-phosphate dehydrogenase. Five experimental conditions, including changes in age,developmental stage and feeding status were tested in both sexes. We show that the evaluation of candidate reference genes is necessary for each combination of sex, tissue and physiological condition analyzed in order to avoid inconsistent results and conclusions. Although, Normfinder and geNorm software yielded different results between males and females, five genes (SDH, Tub, GAPDH, Act and G6PDH) appeared in the first positions in all rankings obtained. By using gene expression data of a single olfactory coreceptor gene as an example, we demonstrated the extent of changes expected using different internal standards. This work underlines the need for a rigorous selection of internal standards to grant the reliability of normalization processes in qRT-PCR studies. Furthermore, we show that particular physiological or developmental conditions require independent evaluation of a diverse set of potential reference genes.