9 CFR 106.1 - Biological products; exemption.

Code of Federal Regulations, 2012 CFR

2012-01-01

... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN DEPARTMENT PROGRAMS OR UNDER DEPARTMENT CONTROL OR SUPERVISION § 106.1 Biological products... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Biological products; exemption. 106.1...

9 CFR 106.1 - Biological products; exemption.

Code of Federal Regulations, 2014 CFR

2014-01-01

... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN DEPARTMENT PROGRAMS OR UNDER DEPARTMENT CONTROL OR SUPERVISION § 106.1 Biological products... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Biological products; exemption. 106.1...

9 CFR 106.1 - Biological products; exemption.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN DEPARTMENT PROGRAMS OR UNDER DEPARTMENT CONTROL OR SUPERVISION § 106.1 Biological products... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Biological products; exemption. 106.1...

9 CFR 106.1 - Biological products; exemption.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN DEPARTMENT PROGRAMS OR UNDER DEPARTMENT CONTROL OR SUPERVISION § 106.1 Biological products... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Biological products; exemption. 106.1...

9 CFR 106.1 - Biological products; exemption.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN DEPARTMENT PROGRAMS OR UNDER DEPARTMENT CONTROL OR SUPERVISION § 106.1 Biological products... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Biological products; exemption. 106.1...

9 CFR 318.308 - Deviations in processing.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) Deviations in processing (or process deviations) must be handled according to: (1)(i) A HACCP plan for canned..., containers in the retort intake valve and in transfer valves between retort shells at the time of a jam or... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Deviations in processing. 318.308...

9 CFR 113.50 - Ingredients of biological products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Ingredients of biological products... REQUIREMENTS Ingredient Requirements § 113.50 Ingredients of biological products. All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be sufficiently...

Natural production of biological optical systems

NASA Astrophysics Data System (ADS)

Choi, Seung Ho; Kim, Young L.

2015-03-01

Synthesis and production in nature often provide ideas to design and fabricate advanced biomimetic photonic materials and structures, leading to excellent physical properties and enhanced performance. In addition, the recognition and utilization of natural or biological substances have been typical routes to develop biocompatible and biodegradable materials for medical applications. In this respect, biological lasers utilizing such biomaterials and biostructures have been received considerable attention, given a variety of implications and potentials for bioimaging, biosensing, implantation, and therapy. However, without relying on industrial facilities, eco-friendly massive production of such optical components or systems has not yet been investigated. We show examples of bioproduction of biological lasers using agriculture and fisheries. We anticipate that such approaches will open new possibilities for scalable eco-friendly `green' production of biological photonics components and systems.

9 CFR 103.1 - Preparation of experimental biological products.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Preparation of experimental biological... PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING § 103.1 Preparation of experimental biological products. Except as otherwise provided in this section, experimental biological...

9 CFR 103.1 - Preparation of experimental biological products.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Preparation of experimental biological... PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING § 103.1 Preparation of experimental biological products. Except as otherwise provided in this section, experimental biological...

9 CFR 103.1 - Preparation of experimental biological products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Preparation of experimental biological... PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING § 103.1 Preparation of experimental biological products. Except as otherwise provided in this section, experimental biological...

40 CFR 63.2990 - Can I conduct short-term experimental production runs that cause parameters to deviate from...

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 12 2011-07-01 2009-07-01 true Can I conduct short-term experimental... I conduct short-term experimental production runs that cause parameters to deviate from operating limits? With the approval of the Administrator, you may conduct short-term experimental production runs...

40 CFR 63.2990 - Can I conduct short-term experimental production runs that cause parameters to deviate from...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 12 2010-07-01 2010-07-01 true Can I conduct short-term experimental... I conduct short-term experimental production runs that cause parameters to deviate from operating limits? With the approval of the Administrator, you may conduct short-term experimental production runs...

9 CFR 102.5 - U.S. Veterinary Biological Product License.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false U.S. Veterinary Biological Product... BIOLOGICAL PRODUCTS § 102.5 U.S. Veterinary Biological Product License. (a) Authorization to produce each biological product shall be specified on a U.S. Veterinary Biological Product License, issued by the...

9 CFR 102.5 - U.S. Veterinary Biological Product License.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false U.S. Veterinary Biological Product... BIOLOGICAL PRODUCTS § 102.5 U.S. Veterinary Biological Product License. (a) Authorization to produce each biological product shall be specified on a U.S. Veterinary Biological Product License, issued by the...

Design control considerations for biologic-device combination products.

PubMed

Anderson, Dave; Liu, Roger; Anand Subramony, J; Cammack, Jon

2017-03-01

Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products. As innovative as biologic-device combination products are, they can pose considerable development, regulatory, and commercialization challenges due to unique physicochemical properties and special clinical considerations (e.g., dosing volumes, frequency, co-medications, etc.) of the biologic medicine. A biologic-device combination product is a marriage between two partners with "cultural differences," so to speak. There are clear differences in the development, review, and commercialization processes of the biologic and the device. When these two cultures come together in a combination product, developers and reviewers must find ways to address the design controls and risk management processes of both the biologic and device, and knit them into a single entity with supporting product approval documentation. Moreover, digital medicine and connected health trends are pushing the boundaries of combination product development and regulations even further. Despite an admirable cooperation between industry and FDA in recent years, unique product configurations and design features have resulted in review challenges. These challenges have prompted agency reviewers to modernize consultation processes, while at the same time, promoting

Biosynthesis of therapeutic natural products using synthetic biology.

PubMed

Awan, Ali R; Shaw, William M; Ellis, Tom

2016-10-01

Natural products are a group of bioactive structurally diverse chemicals produced by microorganisms and plants. These molecules and their derivatives have contributed to over a third of the therapeutic drugs produced in the last century. However, over the last few decades traditional drug discovery pipelines from natural products have become far less productive and far more expensive. One recent development with promise to combat this trend is the application of synthetic biology to therapeutic natural product biosynthesis. Synthetic biology is a young discipline with roots in systems biology, genetic engineering, and metabolic engineering. In this review, we discuss the use of synthetic biology to engineer improved yields of existing therapeutic natural products. We further describe the use of synthetic biology to combine and express natural product biosynthetic genes in unprecedented ways, and how this holds promise for opening up completely new avenues for drug discovery and production. Copyright © 2016 Elsevier B.V. All rights reserved.

Plankton Production Biology

DTIC Science & Technology

2013-09-30

population dynamics (growth rate, production, mortality) of copepod nauplii in the field or captured water columns (mesocosms). Since biology...36-45, doi:10.1016/j.dsr.2012.03.001, 2012. PUBLICATIONS Banse, K., Naqvi, S.W.A., Narvekar, P.V., Postel, J.R., Jayakumar , D.A. Oxygen minimum

9 CFR 381.308 - Deviations in processing.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., containers in the retort intake valve and in transfer valves between retort shells at the time of a jam or... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Deviations in processing. 381.308... Deviations in processing. (a) Whenever the actual process is less than the process schedule or when any...

9 CFR 113.3 - Sampling of biological products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Sampling of biological products. 113.3 Section 113.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF... Applicability § 113.3 Sampling of biological products. Each licensee and permittee shall furnish representative...

9 CFR 113.3 - Sampling of biological products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Sampling of biological products. 113.3 Section 113.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF... Applicability § 113.3 Sampling of biological products. Each licensee and permittee shall furnish representative...

9 CFR 103.1 - Preparation of experimental biological products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Preparation of experimental biological products. 103.1 Section 103.1 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING § 103.1 Preparation of...

Influence of asymmetrical drawing radius deviation in micro deep drawing

NASA Astrophysics Data System (ADS)

Heinrich, L.; Kobayashi, H.; Shimizu, T.; Yang, M.; Vollertsen, F.

2017-09-01

Nowadays, an increasing demand for small metal parts in electronic and automotive industries can be observed. Deep drawing is a well-suited technology for the production of such parts due to its excellent qualities for mass production. However, the downscaling of the forming process leads to new challenges in tooling and process design, such as high relative deviation of tool geometry or blank displacement compared to the macro scale. FEM simulation has been a widely-used tool to investigate the influence of symmetrical process deviations as for instance a global variance of the drawing radius. This study shows a different approach that allows to determine the impact of asymmetrical process deviations on micro deep drawing. In this particular case the impact of an asymmetrical drawing radius deviation and blank displacement on cup geometry deviation was investigated for different drawing ratios by experiments and FEM simulation. It was found that both variations result in an increasing cup height deviation. Nevertheless, with increasing drawing ratio a constant drawing radius deviation has an increasing impact, while blank displacement results in a decreasing offset of the cups geometry. This is explained by different mechanisms that result in an uneven cup geometry. While blank displacement leads to material surplus on one side of the cup, an unsymmetrical radius deviation on the other hand generates uneven stretching of the cups wall. This is intensified for higher drawing ratios. It can be concluded that the effect of uneven radius geometry proves to be of major importance for the production of accurately shaped micro cups and cannot be compensated by intentional blank displacement.

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

[Building confidence in biological products].

PubMed

Rosdahl, Nils; Hardy, Anne

2006-01-01

During the last decades of the 19th century, discoveries in microbiology paved the way for health programmes as an integral part of social modernisation. Public opinion about the consequences for governmental involvement differed, but in Denmark the state's openness to modern medicine encouraged the establishment of Statens Serum Institut (SSI) in 1902, initially for the production of anti-diphtheritic serum. Under its director, Thorvald Madsen (1870-1957), the SSI soon acquired a reputation for the high quality of its products and its cutting edge research. After qualifying in medicine in 1893, Madsen worked both at the Pasteur Institute and with Paul Ehrlich in Frankfurt. During World War I, he served with the Red Cross, caring for German, Austrian and Russian prisoners of war. He had an extensive and expanding network of international contacts, and he was eminently qualified to assume the elected office of President of the League of Nations' Health Committee. The Committee served as the 'parliamentary body' of the League of Nations Health Organisation (LNHO), and Madsen's hand can be seen in much of the work undertaken by the LNHO. The drive to achieve uniform standards for biological products related directly to his own as well as the SSI's interests and expertise. Undoubtedly, standardization of biological products had an immense importance for their distribution, scientifically, commercially and therapeutically. Madsen was president of the LNHO's Commission on Biological Standardisation from 1924, and during the interwar years, the SSI was heavily involved in establishing standards for biological products such as tuberculin and tetanus antitoxin. Madsen's interests extended to application of prevention technologies, and he utilised the opportunities in Denmark to further their use, notably in the case of tuberculosis. The introduction of the BCG vaccine promised a solution to the TB problem, but the Lübeck disaster generated a widespread reaction against the

40 CFR 63.2990 - Can I conduct short-term experimental production runs that cause parameters to deviate from...

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 13 2013-07-01 2012-07-01 true Can I conduct short-term experimental... Plan § 63.2990 Can I conduct short-term experimental production runs that cause parameters to deviate from operating limits? With the approval of the Administrator, you may conduct short-term experimental...

Transfer of myelin-specific cells deviated in vitro towards IL-4 production ameliorates ongoing experimental allergic neuritis

PubMed Central

Ekerfelt, C; Dahle, C; Weissert, R; Kvarnström, M; Olsson, T; Ernerudh, J

2001-01-01

A causal role of IL-4 (Th2) production for recovery in experimental allergic neuritis (EAN) was indicated by experiments where Th1-like autoreactive cell populations, taken from the induction phase of the disease, were deviated to extensive secretion of IL-4 in a selective fashion, by ex vivo stimulation with autoantigen in the presence of IL-4. The deviated cells were adoptively transferred to EAN rats at a time just prior to the onset of clinical signs. This treatment ameliorated EAN compared with sham treatment. This therapeutic approach, with generation of autoreactive IL-4-secreting cells ex vivo followed by subsequent adoptive transfer, may become a new selective treatment of organ-specific autoimmune diseases since, in contrast to previous attempts, it is done in a physiological and technically easy way. PMID:11168007

Synthetic biology advances for pharmaceutical production

PubMed Central

Breitling, Rainer; Takano, Eriko

2015-01-01

Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems. PMID:25744872

9 CFR 112.9 - Biological products imported for research and evaluation.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Biological products imported for research and evaluation. 112.9 Section 112.9 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... PACKAGING AND LABELING § 112.9 Biological products imported for research and evaluation. A biological...

9 CFR 112.9 - Biological products imported for research and evaluation.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Biological products imported for research and evaluation. 112.9 Section 112.9 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... PACKAGING AND LABELING § 112.9 Biological products imported for research and evaluation. A biological...

9 CFR 112.9 - Biological products imported for research and evaluation.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Biological products imported for research and evaluation. 112.9 Section 112.9 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... PACKAGING AND LABELING § 112.9 Biological products imported for research and evaluation. A biological...

9 CFR 112.9 - Biological products imported for research and evaluation.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Biological products imported for research and evaluation. 112.9 Section 112.9 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... PACKAGING AND LABELING § 112.9 Biological products imported for research and evaluation. A biological...

9 CFR 112.9 - Biological products imported for research and evaluation.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Biological products imported for research and evaluation. 112.9 Section 112.9 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... PACKAGING AND LABELING § 112.9 Biological products imported for research and evaluation. A biological...

9 CFR 112.6 - Packaging biological products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Packaging biological products. 112.6 Section 112.6 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF... if seal is broken.” (d) Diluent for the following products need not be packaged with the final...

9 CFR 112.6 - Packaging biological products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Packaging biological products. 112.6 Section 112.6 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF... if seal is broken.” (d) Diluent for the following products need not be packaged with the final...

Yeast synthetic biology toolbox and applications for biofuel production.

PubMed

Tsai, Ching-Sung; Kwak, Suryang; Turner, Timothy L; Jin, Yong-Su

2015-02-01

Yeasts are efficient biofuel producers with numerous advantages outcompeting bacterial counterparts. While most synthetic biology tools have been developed and customized for bacteria especially for Escherichia coli, yeast synthetic biological tools have been exploited for improving yeast to produce fuels and chemicals from renewable biomass. Here we review the current status of synthetic biological tools and their applications for biofuel production, focusing on the model strain Saccharomyces cerevisiae We describe assembly techniques that have been developed for constructing genes, pathways, and genomes in yeast. Moreover, we discuss synthetic parts for allowing precise control of gene expression at both transcriptional and translational levels. Applications of these synthetic biological approaches have led to identification of effective gene targets that are responsible for desirable traits, such as cellulosic sugar utilization, advanced biofuel production, and enhanced tolerance against toxic products for biofuel production from renewable biomass. Although an array of synthetic biology tools and devices are available, we observed some gaps existing in tool development to achieve industrial utilization. Looking forward, future tool development should focus on industrial cultivation conditions utilizing industrial strains. © FEMS 2015. All rights reserved. For permissions, please e-mail: journals.permission@oup.com.

21 CFR 510.4 - Biologics; products subject to license control.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Biologics; products subject to license control... Biologics; products subject to license control. An animal drug produced and distributed in full conformance..., Drug, and Cosmetic Act. ...

21 CFR 510.4 - Biologics; products subject to license control.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Biologics; products subject to license control... Biologics; products subject to license control. An animal drug produced and distributed in full conformance..., Drug, and Cosmetic Act. ...

21 CFR 510.4 - Biologics; products subject to license control.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Biologics; products subject to license control... Biologics; products subject to license control. An animal drug produced and distributed in full conformance..., Drug, and Cosmetic Act. ...

9 CFR 381.308 - Deviations in processing.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) must be handled according to: (1)(i) A HACCP plan for canned product that addresses hazards associated... (d) of this section. (c) [Reserved] (d) Procedures for handling process deviations where the HACCP... accordance with the following procedures: (a) Emergency stops. (1) When retort jams or breakdowns occur...

Synthetic Biology Guides Biofuel Production

PubMed Central

Connor, Michael R.; Atsumi, Shota

2010-01-01

The advancement of microbial processes for the production of renewable liquid fuels has increased with concerns about the current fuel economy. The development of advanced biofuels in particular has risen to address some of the shortcomings of ethanol. These advanced fuels have chemical properties similar to petroleum-based liquid fuels, thus removing the need for engine modification or infrastructure redesign. While the productivity and titers of each of these processes remains to be improved, progress in synthetic biology has provided tools to guide the engineering of these processes through present and future challenges. PMID:20827393

9 CFR 118.3 - Movement of detained biological products; Termination of detention.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Movement of detained biological... VECTORS DETENTION; SEIZURE AND CONDEMNATION § 118.3 Movement of detained biological products; Termination of detention. Except as provided in paragraphs (a) and (b) of this section, no biological product...

9 CFR 115.2 - Inspections of biological products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... United States veterinary license number or a United States veterinary permit number or other mark...) When notified to stop distribution and sale of a serial or subserial of a veterinary biological product by the Secretary, veterinary biologics licensees or permittees shall: (1) Stop the preparation...

9 CFR 115.2 - Inspections of biological products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... United States veterinary license number or a United States veterinary permit number or other mark...) When notified to stop distribution and sale of a serial or subserial of a veterinary biological product by the Secretary, veterinary biologics licensees or permittees shall: (1) Stop the preparation...

Applications of systems biology towards microbial fuel production.

PubMed

Gowen, Christopher M; Fong, Stephen S

2011-10-01

Harnessing the immense natural diversity of biological functions for economical production of fuel has enormous potential benefits. Inevitably, however, the native capabilities for any given organism must be modified to increase the productivity or efficiency of a biofuel bioprocess. From a broad perspective, the challenge is to sufficiently understand the details of cellular functionality to be able to prospectively predict and modify the cellular function of a microorganism. Recent advances in experimental and computational systems biology approaches can be used to better understand cellular level function and guide future experiments. With pressure to quickly develop viable, renewable biofuel processes a balance must be maintained between obtaining depth of biological knowledge and applying that knowledge. Copyright © 2011 Elsevier Ltd. All rights reserved.

Heterogeneity-induced large deviations in activity and (in some cases) entropy production

NASA Astrophysics Data System (ADS)

Gingrich, Todd R.; Vaikuntanathan, Suriyanarayanan; Geissler, Phillip L.

2014-10-01

We solve a simple model that supports a dynamic phase transition and show conditions for the existence of the transition. Using methods of large deviation theory we analytically compute the probability distribution for activity and entropy production rates of the trajectories on a large ring with a single heterogeneous link. The corresponding joint rate function demonstrates two dynamical phases—one localized and the other delocalized, but the marginal rate functions do not always exhibit the underlying transition. Symmetries in dynamic order parameters influence the observation of a transition, such that distributions for certain dynamic order parameters need not reveal an underlying dynamical bistability. Solution of our model system furthermore yields the form of the effective Markov transition matrices that generate dynamics in which the two dynamical phases are at coexistence. We discuss the implications of the transition for the response of bacterial cells to antibiotic treatment, arguing that even simple models of a cell cycle lacking an explicit bistability in configuration space will exhibit a bistability of dynamical phases.

9 CFR 114.18 - Reprocessing of biological products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... for all tests conducted shall be submitted to Animal and Plant Health Inspection Service. The licensee... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Reprocessing of biological products. 114.18 Section 114.18 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE...

9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., dangerous, or harmful biological products. 105.3 Section 105.3 Animals and Animal Products ANIMAL AND PLANT... Notices re: worthless, contaminated, dangerous, or harmful biological products. (a) If at any time it...-Serum-Toxin Act, of any biological product by any person holding a license or permit may be dangerous in...

9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., dangerous, or harmful biological products. 105.3 Section 105.3 Animals and Animal Products ANIMAL AND PLANT... Notices re: worthless, contaminated, dangerous, or harmful biological products. (a) If at any time it...-Serum-Toxin Act, of any biological product by any person holding a license or permit may be dangerous in...

9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., dangerous, or harmful biological products. 105.3 Section 105.3 Animals and Animal Products ANIMAL AND PLANT... Notices re: worthless, contaminated, dangerous, or harmful biological products. (a) If at any time it...-Serum-Toxin Act, of any biological product by any person holding a license or permit may be dangerous in...

Biodegradation of phytosanitary products in biological wastewater treatment.

PubMed

Massot, A; Estève, K; Noilet, P; Méoule, C; Poupot, C; Mietton-Peuchot, M

2012-04-15

Agricultural activity generates two types of waste: firstly, biodegradable organic effluents generally treated by biological processes and, secondly, phytosanitary effluents which contain residues of plant protection products. The latter are collected and treated. Current technological solutions are essentially based on concentration or physical-chemical processes. However, recent improvements in the biodegradability of pesticides open the way to the consideration of alternative, biological, treatment using mixed liquor from wastewater plant activated sludge. The feasibility of the biological treatment of viticultural effluents has been evaluated by the application of pesticides to activated sludge. The necessity for selection of a pesticide-resistant biomass has been highlighted. The elimination of the phytosanitary products shows the potential of a resistant biomass in the treatment of pesticides. The aerated biological storage ponds at three wineries, followed by a sand or reed-bed filter, were used for the treatment of the total annual volume of the viticulture effluents and validate the laboratory experiments. The results show that the biological purification of pesticides by activated sludge is possible by allowing approximately 8 days for biomass adaptation. Stability of purification occurs between 20 and 30 days. Copyright © 2012 Elsevier Ltd. All rights reserved.

21 CFR 310.4 - Biologics; products subject to license control.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Biologics; products subject to license control... to license control. (a) If a drug has an approved license under section 351 of the Public Health.... (b) To obtain marketing approval for radioactive biological products for human use, as defined in...

21 CFR 310.4 - Biologics; products subject to license control.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Biologics; products subject to license control... to license control. (a) If a drug has an approved license under section 351 of the Public Health.... (b) To obtain marketing approval for radioactive biological products for human use, as defined in...

21 CFR 310.4 - Biologics; products subject to license control.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Biologics; products subject to license control... to license control. (a) If a drug has an approved license under section 351 of the Public Health.... (b) To obtain marketing approval for radioactive biological products for human use, as defined in...

21 CFR 310.4 - Biologics; products subject to license control.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Biologics; products subject to license control... to license control. (a) If a drug has an approved license under section 351 of the Public Health.... (b) To obtain marketing approval for radioactive biological products for human use, as defined in...

21 CFR 310.4 - Biologics; products subject to license control.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Biologics; products subject to license control... to license control. (a) If a drug has an approved license under section 351 of the Public Health.... (b) To obtain marketing approval for radioactive biological products for human use, as defined in...

78 FR 60884 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-02

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Immunoregulation, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics...

76 FR 44016 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research...

9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.

Code of Federal Regulations, 2011 CFR

2011-01-01

... research sponsor to control disposition of all animals administered experimental biological products or... experimental biological products or live organisms. 103.2 Section 103.2 Animals and Animal Products ANIMAL AND... PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL...

77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-25

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The...

9 CFR 103.3 - Shipment of experimental biological products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... products. 103.3 Section 103.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING § 103.3 Shipment of... Animal and Plant Health Inspection Service. (f) Data acceptable to the Administrator demonstrating that...

9 CFR 103.1 - Preparation of experimental biological products.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Preparation of experimental biological products. 103.1 Section 103.1 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL...

Wavelength selection method with standard deviation: application to pulse oximetry.

PubMed

Vazquez-Jaccaud, Camille; Paez, Gonzalo; Strojnik, Marija

2011-07-01

Near-infrared spectroscopy provides useful biological information after the radiation has penetrated through the tissue, within the therapeutic window. One of the significant shortcomings of the current applications of spectroscopic techniques to a live subject is that the subject may be uncooperative and the sample undergoes significant temporal variations, due to his health status that, from radiometric point of view, introduce measurement noise. We describe a novel wavelength selection method for monitoring, based on a standard deviation map, that allows low-noise sensitivity. It may be used with spectral transillumination, transmission, or reflection signals, including those corrupted by noise and unavoidable temporal effects. We apply it to the selection of two wavelengths for the case of pulse oximetry. Using spectroscopic data, we generate a map of standard deviation that we propose as a figure-of-merit in the presence of the noise introduced by the living subject. Even in the presence of diverse sources of noise, we identify four wavelength domains with standard deviation, minimally sensitive to temporal noise, and two wavelengths domains with low sensitivity to temporal noise.

Development and operation of a quality assurance system for deviations from standard operating procedures in a clinical cell therapy laboratory.

PubMed

McKenna, D; Kadidlo, D; Sumstad, D; McCullough, J

2003-01-01

Errors and accidents, or deviations from standard operating procedures, other policy, or regulations must be documented and reviewed, with corrective actions taken to assure quality performance in a cellular therapy laboratory. Though expectations and guidance for deviation management exist, a description of the framework for the development of such a program is lacking in the literature. Here we describe our deviation management program, which uses a Microsoft Access database and Microsoft Excel to analyze deviations and notable events, facilitating quality assurance (QA) functions and ongoing process improvement. Data is stored in a Microsoft Access database with an assignment to one of six deviation type categories. Deviation events are evaluated for potential impact on patient and product, and impact scores for each are determined using a 0- 4 grading scale. An immediate investigation occurs, and corrective actions are taken to prevent future similar events from taking place. Additionally, deviation data is collectively analyzed on a quarterly basis using Microsoft Excel, to identify recurring events or developing trends. Between January 1, 2001 and December 31, 2001 over 2500 products were processed at our laboratory. During this time period, 335 deviations and notable events occurred, affecting 385 products and/or patients. Deviations within the 'technical error' category were most common (37%). Thirteen percent of deviations had a patient and/or a product impact score > or = 2, a score indicating, at a minimum, potentially affected patient outcome or moderate effect upon product quality. Real-time analysis and quarterly review of deviations using our deviation management program allows for identification and correction of deviations. Monitoring of deviation trends allows for process improvement and overall successful functioning of the QA program in the cell therapy laboratory. Our deviation management program could serve as a model for other laboratories in

Deviation-based spam-filtering method via stochastic approach

NASA Astrophysics Data System (ADS)

Lee, Daekyung; Lee, Mi Jin; Kim, Beom Jun

2018-03-01

In the presence of a huge number of possible purchase choices, ranks or ratings of items by others often play very important roles for a buyer to make a final purchase decision. Perfectly objective rating is an impossible task to achieve, and we often use an average rating built on how previous buyers estimated the quality of the product. The problem of using a simple average rating is that it can easily be polluted by careless users whose evaluation of products cannot be trusted, and by malicious spammers who try to bias the rating result on purpose. In this letter we suggest how trustworthiness of individual users can be systematically and quantitatively reflected to build a more reliable rating system. We compute the suitably defined reliability of each user based on the user's rating pattern for all products she evaluated. We call our proposed method as the deviation-based ranking, since the statistical significance of each user's rating pattern with respect to the average rating pattern is the key ingredient. We find that our deviation-based ranking method outperforms existing methods in filtering out careless random evaluators as well as malicious spammers.

Biological Activity of Recently Discovered Halogenated Marine Natural Products

PubMed Central

Gribble, Gordon W.

2015-01-01

This review presents the biological activity—antibacterial, antifungal, anti-parasitic, antiviral, antitumor, antiinflammatory, antioxidant, and enzymatic activity—of halogenated marine natural products discovered in the past five years. Newly discovered examples that do not report biological activity are not included. PMID:26133553

Systems biology and livestock production.

PubMed

Headon, D

2013-12-01

The mapping of complete sets of genes, transcripts and proteins from many organisms has prompted the development of new '-omic' technologies for collecting and analysing very large amounts of data. Now that the tools to generate and interrogate such complete data sets are widely used, much of the focus of biological research has begun to turn towards understanding systems as a whole, rather than studying their components in isolation. This very broadly defined systems approach is being deployed across a range of problems and scales of organisation, including many aspects of the animal sciences. Here I review selected examples of this systems approach as applied to poultry and livestock production, product quality and welfare.

Estimate of standard deviation for a log-transformed variable using arithmetic means and standard deviations.

PubMed

Quan, Hui; Zhang, Ji

2003-09-15

Analyses of study variables are frequently based on log transformations. To calculate the power for detecting the between-treatment difference in the log scale, we need an estimate of the standard deviation of the log-transformed variable. However, in many situations a literature search only provides the arithmetic means and the corresponding standard deviations. Without individual log-transformed data to directly calculate the sample standard deviation, we need alternative methods to estimate it. This paper presents methods for estimating and constructing confidence intervals for the standard deviation of a log-transformed variable given the mean and standard deviation of the untransformed variable. It also presents methods for estimating the standard deviation of change from baseline in the log scale given the means and standard deviations of the untransformed baseline value, on-treatment value and change from baseline. Simulations and examples are provided to assess the performance of these estimates. Copyright 2003 John Wiley & Sons, Ltd.

48 CFR 2001.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Individual deviations. 2001... Individual deviations. In individual cases, deviations from either the FAR or the NRCAR will be authorized... deviations clearly in the best interest of the Government. Individual deviations must be authorized in...

9 CFR 113.53 - Requirements for ingredients of animal origin used for production of biologics.

Code of Federal Regulations, 2011 CFR

2011-01-01

... biological product shall be tested as prescribed in this section by the licensee or a laboratory acceptable... prepare a biological product. A serial of biological product shall not be released if produced using an... animal origin which is not subjected to heat sterilization, used to prepare a biological product shall be...

48 CFR 801.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Individual deviations. 801... Individual deviations. (a) Authority to authorize individual deviations from the FAR and VAAR is delegated to... nature of the deviation. (d) The DSPE may authorize individual deviations from the FAR and VAAR when an...

Versatile and on-demand biologics co-production in yeast.

PubMed

Cao, Jicong; Perez-Pinera, Pablo; Lowenhaupt, Ky; Wu, Ming-Ru; Purcell, Oliver; de la Fuente-Nunez, Cesar; Lu, Timothy K

2018-01-08

Current limitations to on-demand drug manufacturing can be addressed by technologies that streamline manufacturing processes. Combining the production of two or more drugs into a single batch could not only be useful for research, clinical studies, and urgent therapies but also effective when combination therapies are needed or where resources are scarce. Here we propose strategies to concurrently produce multiple biologics from yeast in single batches by multiplexing strain development, cell culture, separation, and purification. We demonstrate proof-of-concept for three biologics co-production strategies: (i) inducible expression of multiple biologics and control over the ratio between biologic drugs produced together; (ii) consolidated bioprocessing; and (iii) co-expression and co-purification of a mixture of two monoclonal antibodies. We then use these basic strategies to produce drug mixtures as well as to separate drugs. These strategies offer a diverse array of options for on-demand, flexible, low-cost, and decentralized biomanufacturing applications without the need for specialized equipment.

78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to...

LD-SPatt: large deviations statistics for patterns on Markov chains.

PubMed

Nuel, G

2004-01-01

Statistics on Markov chains are widely used for the study of patterns in biological sequences. Statistics on these models can be done through several approaches. Central limit theorem (CLT) producing Gaussian approximations are one of the most popular ones. Unfortunately, in order to find a pattern of interest, these methods have to deal with tail distribution events where CLT is especially bad. In this paper, we propose a new approach based on the large deviations theory to assess pattern statistics. We first recall theoretical results for empiric mean (level 1) as well as empiric distribution (level 2) large deviations on Markov chains. Then, we present the applications of these results focusing on numerical issues. LD-SPatt is the name of GPL software implementing these algorithms. We compare this approach to several existing ones in terms of complexity and reliability and show that the large deviations are more reliable than the Gaussian approximations in absolute values as well as in terms of ranking and are at least as reliable as compound Poisson approximations. We then finally discuss some further possible improvements and applications of this new method.

9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... serial or subserial of a veterinary biological product under the provisions of paragraph (a) or (b) of this section, veterinary biologics licensees or permittees shall: (1) Stop the preparation... veterinary biological product pending further instructions from APHIS. (2) Immediately, but no later than 2...

9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... serial or subserial of a veterinary biological product under the provisions of paragraph (a) or (b) of this section, veterinary biologics licensees or permittees shall: (1) Stop the preparation... veterinary biological product pending further instructions from APHIS. (2) Immediately, but no later than 2...

10 CFR 602.4 - Deviations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Deviations. 602.4 Section 602.4 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS EPIDEMIOLOGY AND OTHER HEALTH STUDIES FINANCIAL ASSISTANCE PROGRAM § 602.4 Deviations. (a) Single-case deviations from this part may be authorized in writing by the...

10 CFR 602.4 - Deviations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Deviations. 602.4 Section 602.4 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS EPIDEMIOLOGY AND OTHER HEALTH STUDIES FINANCIAL ASSISTANCE PROGRAM § 602.4 Deviations. (a) Single-case deviations from this part may be authorized in writing by the...

10 CFR 602.4 - Deviations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Deviations. 602.4 Section 602.4 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS EPIDEMIOLOGY AND OTHER HEALTH STUDIES FINANCIAL ASSISTANCE PROGRAM § 602.4 Deviations. (a) Single-case deviations from this part may be authorized in writing by the...

10 CFR 602.4 - Deviations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Deviations. 602.4 Section 602.4 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS EPIDEMIOLOGY AND OTHER HEALTH STUDIES FINANCIAL ASSISTANCE PROGRAM § 602.4 Deviations. (a) Single-case deviations from this part may be authorized in writing by the...

10 CFR 602.4 - Deviations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Deviations. 602.4 Section 602.4 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS EPIDEMIOLOGY AND OTHER HEALTH STUDIES FINANCIAL ASSISTANCE PROGRAM § 602.4 Deviations. (a) Single-case deviations from this part may be authorized in writing by the...

48 CFR 1501.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Individual deviations. 1501.403 Section 1501.403 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY GENERAL GENERAL Deviations 1501.403 Individual deviations. Requests for individual deviations from the FAR and the...

76 FR 13646 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-14

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review...

37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.

Code of Federal Regulations, 2011 CFR

2011-07-01

... extension for a veterinary biological product. 1.779 Section 1.779 Patents, Trademarks, and Copyrights... Calculation of patent term extension for a veterinary biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a veterinary biological product is eligible for extension, the term...

37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.

Code of Federal Regulations, 2010 CFR

2010-07-01

... extension for a veterinary biological product. 1.779 Section 1.779 Patents, Trademarks, and Copyrights... Calculation of patent term extension for a veterinary biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a veterinary biological product is eligible for extension, the term...

48 CFR 2401.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Individual deviations. 2401... DEVELOPMENT GENERAL FEDERAL ACQUISITION REGULATION SYSTEM Deviations 2401.403 Individual deviations. In individual cases, proposed deviations from the FAR or HUDAR shall be submitted to the Senior Procurement...

48 CFR 3401.404 - Class deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Class deviations. 3401.404 Section 3401.404 Federal Acquisition Regulations System DEPARTMENT OF EDUCATION ACQUISITION REGULATION GENERAL ED ACQUISITION REGULATION SYSTEM Deviations 3401.404 Class deviations. A class deviation from the...

10 CFR 961.4 - Deviations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Deviations. 961.4 Section 961.4 Energy DEPARTMENT OF ENERGY STANDARD CONTRACT FOR DISPOSAL OF SPENT NUCLEAR FUEL AND/OR HIGH-LEVEL RADIOACTIVE WASTE General § 961.4 Deviations. Requests for authority to deviate from this part shall be submitted in writing to...

10 CFR 961.4 - Deviations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Deviations. 961.4 Section 961.4 Energy DEPARTMENT OF ENERGY STANDARD CONTRACT FOR DISPOSAL OF SPENT NUCLEAR FUEL AND/OR HIGH-LEVEL RADIOACTIVE WASTE General § 961.4 Deviations. Requests for authority to deviate from this part shall be submitted in writing to...

10 CFR 961.4 - Deviations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Deviations. 961.4 Section 961.4 Energy DEPARTMENT OF ENERGY STANDARD CONTRACT FOR DISPOSAL OF SPENT NUCLEAR FUEL AND/OR HIGH-LEVEL RADIOACTIVE WASTE General § 961.4 Deviations. Requests for authority to deviate from this part shall be submitted in writing to...

10 CFR 961.4 - Deviations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Deviations. 961.4 Section 961.4 Energy DEPARTMENT OF ENERGY STANDARD CONTRACT FOR DISPOSAL OF SPENT NUCLEAR FUEL AND/OR HIGH-LEVEL RADIOACTIVE WASTE General § 961.4 Deviations. Requests for authority to deviate from this part shall be submitted in writing to...

10 CFR 961.4 - Deviations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Deviations. 961.4 Section 961.4 Energy DEPARTMENT OF ENERGY STANDARD CONTRACT FOR DISPOSAL OF SPENT NUCLEAR FUEL AND/OR HIGH-LEVEL RADIOACTIVE WASTE General § 961.4 Deviations. Requests for authority to deviate from this part shall be submitted in writing to...

Synthetic biology strategies toward heterologous phytochemical production.

PubMed

Kotopka, Benjamin J; Li, Yanran; Smolke, Christina D

2018-06-13

Covering: 2006 to 2018Phytochemicals are important sources for the discovery and development of agricultural and pharmaceutical compounds, such as pesticides and medicines. However, these compounds are typically present in low abundance in nature, and the biosynthetic pathways for most phytochemicals are not fully elucidated. Heterologous production of phytochemicals in plant, bacterial, and yeast hosts has been pursued as a potential approach to address sourcing issues associated with many valuable phytochemicals, and more recently has been utilized as a tool to aid in the elucidation of plant biosynthetic pathways. Due to the structural complexity of certain phytochemicals and the associated biosynthetic pathways, reconstitution of plant pathways in heterologous hosts can encounter numerous challenges. Synthetic biology approaches have been developed to address these challenges in areas such as precise control over heterologous gene expression, improving functional expression of heterologous enzymes, and modifying central metabolism to increase the supply of precursor compounds into the pathway. These strategies have been applied to advance plant pathway reconstitution and phytochemical production in a wide variety of heterologous hosts. Here, we review synthetic biology strategies that have been recently applied to advance complex phytochemical production in heterologous hosts.

76 FR 55397 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center...

75 FR 47605 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Laboratory of Vector Borne Virus Diseases, Division of Viral Products, Office of Vaccines Research and Review...

48 CFR 1301.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Individual deviations... DEPARTMENT OF COMMERCE ACQUISITION REGULATIONS SYSTEM Deviations From the FAR 1301.403 Individual deviations. The designee authorized to approve individual deviations from the FAR is set forth in CAM 1301.70. ...

48 CFR 301.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Individual deviations. 301... ACQUISITION REGULATION SYSTEM Deviations From the FAR 301.403 Individual deviations. Contracting activities shall prepare requests for individual deviations to either the FAR or HHSAR in accordance with 301.470. ...

48 CFR 1201.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Individual deviations... FEDERAL ACQUISITION REGULATIONS SYSTEM 70-Deviations From the FAR and TAR 1201.403 Individual deviations... Executive Service (SES) official or that of a Flag Officer, may authorize individual deviations (unless (FAR...

9 CFR 102.5 - U.S. Veterinary Biological Product License.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false U.S. Veterinary Biological Product License. 102.5 Section 102.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS LICENSES FOR...

9 CFR 102.5 - U.S. Veterinary Biological Product License.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false U.S. Veterinary Biological Product License. 102.5 Section 102.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS LICENSES FOR...

48 CFR 501.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Individual deviations. 501... Individual deviations. (a) An individual deviation affects only one contract action. (1) The Head of the Contracting Activity (HCA) must approve an individual deviation to the FAR. The authority to grant an...

48 CFR 2801.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Individual deviations. 2801... OF JUSTICE ACQUISITION REGULATIONS SYSTEM Deviations From the FAR and JAR 2801.403 Individual deviations. Individual deviations from the FAR or the JAR shall be approved by the head of the contracting...

48 CFR 401.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Individual deviations. 401... AGRICULTURE ACQUISITION REGULATION SYSTEM Deviations From the FAR and AGAR 401.403 Individual deviations. In individual cases, deviations from either the FAR or the AGAR will be authorized only when essential to effect...

Visualizing the Sample Standard Deviation

ERIC Educational Resources Information Center

Sarkar, Jyotirmoy; Rashid, Mamunur

2017-01-01

The standard deviation (SD) of a random sample is defined as the square-root of the sample variance, which is the "mean" squared deviation of the sample observations from the sample mean. Here, we interpret the sample SD as the square-root of twice the mean square of all pairwise half deviations between any two sample observations. This…

9 CFR 113.51 - Requirements for primary cells used for production of biologics.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Requirements for primary cells used... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used for production of biologics. Primary cells used to prepare biological products shall be derived from normal...

9 CFR 113.51 - Requirements for primary cells used for production of biologics.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Requirements for primary cells used... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used for production of biologics. Primary cells used to prepare biological products shall be derived from normal...

9 CFR 113.51 - Requirements for primary cells used for production of biologics.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Requirements for primary cells used... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used for production of biologics. Primary cells used to prepare biological products shall be derived from normal...

9 CFR 113.51 - Requirements for primary cells used for production of biologics.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Requirements for primary cells used... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used for production of biologics. Primary cells used to prepare biological products shall be derived from normal...

9 CFR 113.51 - Requirements for primary cells used for production of biologics.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Requirements for primary cells used... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used for production of biologics. Primary cells used to prepare biological products shall be derived from normal...

Effect of biological pretreatments in enhancing corn straw biogas production.

PubMed

Zhong, Weizhang; Zhang, Zhongzhi; Luo, Yijing; Sun, Shanshan; Qiao, Wei; Xiao, Meng

2011-12-01

A biological pretreatment with new complex microbial agents was used to pretreat corn straw at ambient temperature (about 20°C) to improve its biodegradability and anaerobic biogas production. A complex microbial agent dose of 0.01% (w/w) and pretreatment time of 15 days were appropriate for biological pretreatment. These treatment conditions resulted in 33.07% more total biogas yield, 75.57% more methane yield, and 34.6% shorter technical digestion time compared with the untreated sample. Analyses of chemical compositions showed 5.81-25.10% reductions in total lignin, cellulose, and hemicellulose contents, and 27.19-80.71% increases in hot-water extractives; these changes contributed to the enhancement of biogas production. Biological pretreatment could be an effective method for improving biodegradability and enhancing the highly efficient biological conversion of corn straw into bioenergy. Copyright © 2011 Elsevier Ltd. All rights reserved.

Systems biology solutions for biochemical production challenges.

PubMed

Hansen, Anne Sofie Lærke; Lennen, Rebecca M; Sonnenschein, Nikolaus; Herrgård, Markus J

2017-06-01

There is an urgent need to significantly accelerate the development of microbial cell factories to produce fuels and chemicals from renewable feedstocks in order to facilitate the transition to a biobased society. Methods commonly used within the field of systems biology including omics characterization, genome-scale metabolic modeling, and adaptive laboratory evolution can be readily deployed in metabolic engineering projects. However, high performance strains usually carry tens of genetic modifications and need to operate in challenging environmental conditions. This additional complexity compared to basic science research requires pushing systems biology strategies to their limits and often spurs innovative developments that benefit fields outside metabolic engineering. Here we survey recent advanced applications of systems biology methods in engineering microbial production strains for biofuels and -chemicals. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Milk kefir: composition, microbial cultures, biological activities, and related products.

PubMed

Prado, Maria R; Blandón, Lina Marcela; Vandenberghe, Luciana P S; Rodrigues, Cristine; Castro, Guillermo R; Thomaz-Soccol, Vanete; Soccol, Carlos R

2015-01-01

In recent years, there has been a strong focus on beneficial foods with probiotic microorganisms and functional organic substances. In this context, there is an increasing interest in the commercial use of kefir, since it can be marketed as a natural beverage that has health promoting bacteria. There are numerous commercially available kefir based-products. Kefir may act as a matrix in the effective delivery of probiotic microorganisms in different types of products. Also, the presence of kefir's exopolysaccharides, known as kefiran, which has biological activity, certainly adds value to products. Kefiran can also be used separately in other food products and as a coating film for various food and pharmaceutical products. This article aims to update the information about kefir and its microbiological composition, biological activity of the kefir's microflora and the importance of kefiran as a beneficial health substance.

Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.

PubMed

Schuck, Robert N; Grillo, Joseph A

2016-05-01

Precision medicine promises to improve both the efficacy and safety of therapeutic products by better informing why some patients respond well to a drug, and some experience adverse reactions, while others do not. Pharmacogenomics is a key component of precision medicine and can be utilized to select optimal doses for patients, more precisely identify individuals who will respond to a treatment and avoid serious drug-related toxicities. Since pharmacogenomic biomarker information can help inform drug dosing, efficacy, and safety, pharmacogenomic data are critically reviewed by FDA staff to ensure effective use of pharmacogenomic strategies in drug development and appropriate incorporation into product labels. Pharmacogenomic information may be provided in drug or biological product labeling to inform health care providers about the impact of genotype on response to a drug through description of relevant genomic markers, functional effects of genomic variants, dosing recommendations based on genotype, and other applicable genomic information. The format and content of labeling for biologic drugs will generally follow that of small molecule drugs; however, there are notable differences in pharmacogenomic information that might be considered useful for biologic drugs in comparison to small molecule drugs. Furthermore, the rapid entry of biologic drugs for treatment of rare genetic diseases and molecularly defined subsets of common diseases will likely lead to increased use of pharmacogenomic information in biologic drug labels in the near future. In this review, we outline the general principles of therapeutic product labeling and discuss the utilization of pharmacogenomic information in biologic drug labels.

9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.

Code of Federal Regulations, 2013 CFR

2013-01-01

... research sponsor to control disposition of all animals administered experimental biological products or... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Disposition of animals administered experimental biological products or live organisms. 103.2 Section 103.2 Animals and Animal Products ANIMAL AND...

9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.

Code of Federal Regulations, 2012 CFR

2012-01-01

... research sponsor to control disposition of all animals administered experimental biological products or... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Disposition of animals administered experimental biological products or live organisms. 103.2 Section 103.2 Animals and Animal Products ANIMAL AND...

9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.

Code of Federal Regulations, 2014 CFR

2014-01-01

... research sponsor to control disposition of all animals administered experimental biological products or... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Disposition of animals administered experimental biological products or live organisms. 103.2 Section 103.2 Animals and Animal Products ANIMAL AND...

Analytical quality goals derived from the total deviation from patients' homeostatic set points, with a margin for analytical errors.

PubMed

Bolann, B J; Asberg, A

2004-01-01

The deviation of test results from patients' homeostatic set points in steady-state conditions may complicate interpretation of the results and the comparison of results with clinical decision limits. In this study the total deviation from the homeostatic set point is defined as the maximum absolute deviation for 95% of measurements, and we present analytical quality requirements that prevent analytical error from increasing this deviation to more than about 12% above the value caused by biology alone. These quality requirements are: 1) The stable systematic error should be approximately 0, and 2) a systematic error that will be detected by the control program with 90% probability, should not be larger than half the value of the combined analytical and intra-individual standard deviation. As a result, when the most common control rules are used, the analytical standard deviation may be up to 0.15 times the intra-individual standard deviation. Analytical improvements beyond these requirements have little impact on the interpretability of measurement results.

Milk kefir: composition, microbial cultures, biological activities, and related products

PubMed Central

Prado, Maria R.; Blandón, Lina Marcela; Vandenberghe, Luciana P. S.; Rodrigues, Cristine; Castro, Guillermo R.; Thomaz-Soccol, Vanete; Soccol, Carlos R.

2015-01-01

In recent years, there has been a strong focus on beneficial foods with probiotic microorganisms and functional organic substances. In this context, there is an increasing interest in the commercial use of kefir, since it can be marketed as a natural beverage that has health promoting bacteria. There are numerous commercially available kefir based-products. Kefir may act as a matrix in the effective delivery of probiotic microorganisms in different types of products. Also, the presence of kefir’s exopolysaccharides, known as kefiran, which has biological activity, certainly adds value to products. Kefiran can also be used separately in other food products and as a coating film for various food and pharmaceutical products. This article aims to update the information about kefir and its microbiological composition, biological activity of the kefir’s microflora and the importance of kefiran as a beneficial health substance. PMID:26579086

allantools: Allan deviation calculation

NASA Astrophysics Data System (ADS)

Wallin, Anders E. E.; Price, Danny C.; Carson, Cantwell G.; Meynadier, Frédéric

2018-04-01

allantools calculates Allan deviation and related time & frequency statistics. The library is written in Python and has a GPL v3+ license. It takes input data that is either evenly spaced observations of either fractional frequency, or phase in seconds. Deviations are calculated for given tau values in seconds. Several noise generators for creating synthetic datasets are also included.

Metabolic engineering with systems biology tools to optimize production of prokaryotic secondary metabolites.

PubMed

Kim, Hyun Uk; Charusanti, Pep; Lee, Sang Yup; Weber, Tilmann

2016-08-27

Covering: 2012 to 2016Metabolic engineering using systems biology tools is increasingly applied to overproduce secondary metabolites for their potential industrial production. In this Highlight, recent relevant metabolic engineering studies are analyzed with emphasis on host selection and engineering approaches for the optimal production of various prokaryotic secondary metabolites: native versus heterologous hosts (e.g., Escherichia coli) and rational versus random approaches. This comparative analysis is followed by discussions on systems biology tools deployed in optimizing the production of secondary metabolites. The potential contributions of additional systems biology tools are also discussed in the context of current challenges encountered during optimization of secondary metabolite production.

Quantifying gait deviations in individuals with rheumatoid arthritis using the Gait Deviation Index.

PubMed

Esbjörnsson, A-C; Rozumalski, A; Iversen, M D; Schwartz, M H; Wretenberg, P; Broström, E W

2014-01-01

In this study we evaluated the usability of the Gait Deviation Index (GDI), an index that summarizes the amount of deviation in movement from a standard norm, in adults with rheumatoid arthritis (RA). The aims of the study were to evaluate the ability of the GDI to identify gait deviations, assess inter-trial repeatability, and examine the relationship between the GDI and walking speed, physical disability, and pain. Sixty-three adults with RA and 59 adults with typical gait patterns were included in this retrospective case-control study. Following a three-dimensional gait analysis (3DGA), representative gait cycles were selected and GDI scores calculated. To evaluate the effect of walking speed, GDI scores were calculated using both a free-speed and a speed-matched reference set. Physical disability was assessed using the Health Assessment Questionnaire (HAQ) and subjects rated their pain during walking. Adults with RA had significantly increased gait deviations compared to healthy individuals, as shown by lower GDI scores [87.9 (SD = 8.7) vs. 99.4 (SD = 8.3), p < 0.001]. This difference was also seen when adjusting for walking speed [91.7 (SD = 9.0) vs. 99.9 (SD = 8.6), p < 0.001]. It was estimated that a change of ≥ 5 GDI units was required to account for natural variation in gait. There was no evident relationship between GDI and low/high RA-related physical disability and pain. The GDI seems to useful for identifying and summarizing gait deviations in individuals with RA. Thus, we consider that the GDI provides an overall measure of gait deviation that may reflect lower extremity pathology and may help clinicians to understand the impact of RA on gait dynamics.

48 CFR 2501.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Individual deviations. 2501.403 Section 2501.403 Federal Acquisition Regulations System NATIONAL SCIENCE FOUNDATION GENERAL FEDERAL ACQUISITION REGULATIONS SYSTEM Deviations From the FAR 2501.403 Individual deviations. Individual...

48 CFR 1.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Individual deviations. 1.403 Section 1.403 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION GENERAL FEDERAL ACQUISITION REGULATIONS SYSTEM Deviations from the FAR 1.403 Individual deviations. Individual...

48 CFR 1.403 - Individual deviations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Individual deviations. 1.403 Section 1.403 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION GENERAL FEDERAL ACQUISITION REGULATIONS SYSTEM Deviations from the FAR 1.403 Individual deviations. Individual...

48 CFR 1.403 - Individual deviations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Individual deviations. 1.403 Section 1.403 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION GENERAL FEDERAL ACQUISITION REGULATIONS SYSTEM Deviations from the FAR 1.403 Individual deviations. Individual...

48 CFR 3401.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Individual deviations. 3401.403 Section 3401.403 Federal Acquisition Regulations System DEPARTMENT OF EDUCATION ACQUISITION REGULATION GENERAL ED ACQUISITION REGULATION SYSTEM Deviations 3401.403 Individual deviations. An individual...

Production of hydrogen using an anaerobic biological process

DOEpatents

Kramer, Robert; Pelter, Libbie S.; Patterson, John A.

2016-11-29

Various embodiments of the present invention pertain to methods for biological production of hydrogen. More specifically, embodiments of the present invention pertain to a modular energy system and related methods for producing hydrogen using organic waste as a feed stock.

48 CFR 601.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Individual deviations. 601.403 Section 601.403 Federal Acquisition Regulations System DEPARTMENT OF STATE GENERAL DEPARTMENT OF STATE ACQUISITION REGULATIONS SYSTEM Deviations from the FAR 601.403 Individual deviations. The...

75 FR 59729 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... vaccines for a post-exposure prophylaxis indication using the animal rule. On November 17, 2010, the...

77 FR 42319 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-18

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... consideration of the appropriateness of cell lines derived from human tumors for vaccine manufacture. FDA...

48 CFR 201.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Individual deviations. 201.403 Section 201.403 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM... Individual deviations. (1) Individual deviations, except those described in 201.402(1) and paragraph (2) of...

48 CFR 2801.404 - Class deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Class deviations. 2801.404 Section 2801.404 Federal Acquisition Regulations System DEPARTMENT OF JUSTICE General DEPARTMENT OF JUSTICE ACQUISITION REGULATIONS SYSTEM Deviations From the FAR and JAR 2801.404 Class deviations. Requests...

WKB theory of large deviations in stochastic populations

NASA Astrophysics Data System (ADS)

Assaf, Michael; Meerson, Baruch

2017-06-01

Stochasticity can play an important role in the dynamics of biologically relevant populations. These span a broad range of scales: from intra-cellular populations of molecules to population of cells and then to groups of plants, animals and people. Large deviations in stochastic population dynamics—such as those determining population extinction, fixation or switching between different states—are presently in a focus of attention of statistical physicists. We review recent progress in applying different variants of dissipative WKB approximation (after Wentzel, Kramers and Brillouin) to this class of problems. The WKB approximation allows one to evaluate the mean time and/or probability of population extinction, fixation and switches resulting from either intrinsic (demographic) noise, or a combination of the demographic noise and environmental variations, deterministic or random. We mostly cover well-mixed populations, single and multiple, but also briefly consider populations on heterogeneous networks and spatial populations. The spatial setting also allows one to study large fluctuations of the speed of biological invasions. Finally, we briefly discuss possible directions of future work.

Synthetic and systems biology for microbial production of commodity chemicals.

PubMed

Chubukov, Victor; Mukhopadhyay, Aindrila; Petzold, Christopher J; Keasling, Jay D; Martín, Héctor García

2016-01-01

The combination of synthetic and systems biology is a powerful framework to study fundamental questions in biology and produce chemicals of immediate practical application such as biofuels, polymers, or therapeutics. However, we cannot yet engineer biological systems as easily and precisely as we engineer physical systems. In this review, we describe the path from the choice of target molecule to scaling production up to commercial volumes. We present and explain some of the current challenges and gaps in our knowledge that must be overcome in order to bring our bioengineering capabilities to the level of other engineering disciplines. Challenges start at molecule selection, where a difficult balance between economic potential and biological feasibility must be struck. Pathway design and construction have recently been revolutionized by next-generation sequencing and exponentially improving DNA synthesis capabilities. Although pathway optimization can be significantly aided by enzyme expression characterization through proteomics, choosing optimal relative protein expression levels for maximum production is still the subject of heuristic, non-systematic approaches. Toxic metabolic intermediates and proteins can significantly affect production, and dynamic pathway regulation emerges as a powerful but yet immature tool to prevent it. Host engineering arises as a much needed complement to pathway engineering for high bioproduct yields; and systems biology approaches such as stoichiometric modeling or growth coupling strategies are required. A final, and often underestimated, challenge is the successful scale up of processes to commercial volumes. Sustained efforts in improving reproducibility and predictability are needed for further development of bioengineering.

Synthetic and systems biology for microbial production of commodity chemicals

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

Chubukov, Victor; Mukhopadhyay, Aindrila; Petzold, Christopher J.

The combination of synthetic and systems biology is a powerful framework to study fundamental questions in biology and produce chemicals of immediate practical application such as biofuels, polymers, or therapeutics. However, we cannot yet engineer biological systems as easily and precisely as we engineer physical systems. In this review, we describe the path from the choice of target molecule to scaling production up to commercial volumes. We present and explain some of the current challenges and gaps in our knowledge that must be overcome in order to bring our bioengineering capabilities to the level of other engineering disciplines. Challenges startmore » at molecule selection, where a difficult balance between economic potential and biological feasibility must be struck. Pathway design and construction have recently been revolutionized by next-generation sequencing and exponentially improving DNA synthesis capabilities. Although pathway optimization can be significantly aided by enzyme expression characterization through proteomics, choosing optimal relative protein expression levels for maximum production is still the subject of heuristic, non-systematic approaches. Toxic metabolic intermediates and proteins can significantly affect production, and dynamic pathway regulation emerges as a powerful but yet immature tool to prevent it. Host engineering arises as a much needed complement to pathway engineering for high bioproduct yields; and systems biology approaches such as stoichiometric modeling or growth coupling strategies are required. A final, and often underestimated, challenge is the successful scale up of processes to commercial volumes. Sustained efforts in improving reproducibility and predictability are needed for further development of bioengineering.« less

Synthetic and systems biology for microbial production of commodity chemicals

DOE PAGES

Chubukov, Victor; Mukhopadhyay, Aindrila; Petzold, Christopher J.; ...

2016-04-07

The combination of synthetic and systems biology is a powerful framework to study fundamental questions in biology and produce chemicals of immediate practical application such as biofuels, polymers, or therapeutics. However, we cannot yet engineer biological systems as easily and precisely as we engineer physical systems. In this review, we describe the path from the choice of target molecule to scaling production up to commercial volumes. We present and explain some of the current challenges and gaps in our knowledge that must be overcome in order to bring our bioengineering capabilities to the level of other engineering disciplines. Challenges startmore » at molecule selection, where a difficult balance between economic potential and biological feasibility must be struck. Pathway design and construction have recently been revolutionized by next-generation sequencing and exponentially improving DNA synthesis capabilities. Although pathway optimization can be significantly aided by enzyme expression characterization through proteomics, choosing optimal relative protein expression levels for maximum production is still the subject of heuristic, non-systematic approaches. Toxic metabolic intermediates and proteins can significantly affect production, and dynamic pathway regulation emerges as a powerful but yet immature tool to prevent it. Host engineering arises as a much needed complement to pathway engineering for high bioproduct yields; and systems biology approaches such as stoichiometric modeling or growth coupling strategies are required. A final, and often underestimated, challenge is the successful scale up of processes to commercial volumes. Sustained efforts in improving reproducibility and predictability are needed for further development of bioengineering.« less

48 CFR 3001.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Individual deviations... from the FAR and HSAR 3001.403 Individual deviations. Unless precluded by law, executive order, or other regulation, the HCA is authorized to approve individual deviation (except with respect to (FAR) 48...

48 CFR 1901.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Individual deviations. 1901.403 Section 1901.403 Federal Acquisition Regulations System BROADCASTING BOARD OF GOVERNORS GENERAL... Individual deviations. Deviations from the IAAR or the FAR in individual cases shall be authorized by the...

76 FR 3639 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-20

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... the influenza virus vaccine for the 2011-2012 influenza season. The committee will also hear an update...

78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... virus vaccine for the 2013- 2014 influenza season. FDA intends to make background material available to...

75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-19

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... virus vaccine for the 2010 - 2011 influenza season. FDA intends to make background material available to...

Dispersion in Rectangular Networks: Effective Diffusivity and Large-Deviation Rate Function

NASA Astrophysics Data System (ADS)

Tzella, Alexandra; Vanneste, Jacques

2016-09-01

The dispersion of a diffusive scalar in a fluid flowing through a network has many applications including to biological flows, porous media, water supply, and urban pollution. Motivated by this, we develop a large-deviation theory that predicts the evolution of the concentration of a scalar released in a rectangular network in the limit of large time t ≫1 . This theory provides an approximation for the concentration that remains valid for large distances from the center of mass, specifically for distances up to O (t ) and thus much beyond the O (t1 /2) range where a standard Gaussian approximation holds. A byproduct of the approach is a closed-form expression for the effective diffusivity tensor that governs this Gaussian approximation. Monte Carlo simulations of Brownian particles confirm the large-deviation results and demonstrate their effectiveness in describing the scalar distribution when t is only moderately large.

76 FR 52668 - Vaccines and Related Biological Products Advisory Committee; Amendment of Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-23

...] Vaccines and Related Biological Products Advisory Committee; Amendment of Notice AGENCY: Food and Drug... notice of meeting of the Vaccines and Related Biological Products Advisory Committee. This meeting was... INFORMATION: In the Federal Register of July 22, 2011, FDA announced that a meeting of the Vaccines and...

78 FR 58311 - Complex Issues in Developing Drug and Biological Products for Rare Diseases; Public Workshop...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-23

...] Complex Issues in Developing Drug and Biological Products for Rare Diseases; Public Workshop; Request for... Issues in Developing Drug and Biological Products for Rare Diseases.'' The purpose of the public workshop is twofold: To discuss complex issues in clinical trials for developing drug and biological products...

Synthetic biology approaches for the production of plant metabolites in unicellular organisms.

PubMed

Moses, Tessa; Mehrshahi, Payam; Smith, Alison G; Goossens, Alain

2017-07-10

Synthetic biology is the repurposing of biological systems for novel objectives and applications. Through the co-ordinated and balanced expression of genes, both native and those introduced from other organisms, resources within an industrial chassis can be siphoned for the commercial production of high-value commodities. This developing interdisciplinary field has the potential to revolutionize natural product discovery from higher plants, by providing a diverse array of tools, technologies, and strategies for exploring the large chemically complex space of plant natural products using unicellular organisms. In this review, we emphasize the key features that influence the generation of biorefineries and highlight technologies and strategic solutions that can be used to overcome engineering pitfalls with rational design. Also presented is a succinct guide to assist the selection of unicellular chassis most suited for the engineering and subsequent production of the desired natural product, in order to meet the global demand for plant natural products in a safe and sustainable manner. © The Author 2017. Published by Oxford University Press on behalf of the Society for Experimental Biology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

7 CFR 2502.3 - Deviations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 15 2014-01-01 2014-01-01 false Deviations. 2502.3 Section 2502.3 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF ADVOCACY AND OUTREACH, DEPARTMENT OF AGRICULTURE AGRICULTURAL CAREER AND EMPLOYMENT (ACE) GRANTS PROGRAM General Information § 2502.3 Deviations...

7 CFR 2502.3 - Deviations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 15 2013-01-01 2013-01-01 false Deviations. 2502.3 Section 2502.3 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF ADVOCACY AND OUTREACH, DEPARTMENT OF AGRICULTURE AGRICULTURAL CAREER AND EMPLOYMENT (ACE) GRANTS PROGRAM General Information § 2502.3 Deviations...

7 CFR 2502.3 - Deviations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 15 2012-01-01 2012-01-01 false Deviations. 2502.3 Section 2502.3 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF ADVOCACY AND OUTREACH, DEPARTMENT OF AGRICULTURE AGRICULTURAL CAREER AND EMPLOYMENT (ACE) GRANTS PROGRAM General Information § 2502.3 Deviations...

Entanglement transitions induced by large deviations

NASA Astrophysics Data System (ADS)

Bhosale, Udaysinh T.

2017-12-01

The probability of large deviations of the smallest Schmidt eigenvalue for random pure states of bipartite systems, denoted as A and B , is computed analytically using a Coulomb gas method. It is shown that this probability, for large N , goes as exp[-β N2Φ (ζ ) ] , where the parameter β is the Dyson index of the ensemble, ζ is the large deviation parameter, while the rate function Φ (ζ ) is calculated exactly. Corresponding equilibrium Coulomb charge density is derived for its large deviations. Effects of the large deviations of the extreme (largest and smallest) Schmidt eigenvalues on the bipartite entanglement are studied using the von Neumann entropy. Effect of these deviations is also studied on the entanglement between subsystems 1 and 2, obtained by further partitioning the subsystem A , using the properties of the density matrix's partial transpose ρ12Γ. The density of states of ρ12Γ is found to be close to the Wigner's semicircle law with these large deviations. The entanglement properties are captured very well by a simple random matrix model for the partial transpose. The model predicts the entanglement transition across a critical large deviation parameter ζ . Log negativity is used to quantify the entanglement between subsystems 1 and 2. Analytical formulas for it are derived using the simple model. Numerical simulations are in excellent agreement with the analytical results.

Entanglement transitions induced by large deviations.

PubMed

Bhosale, Udaysinh T

2017-12-01

The probability of large deviations of the smallest Schmidt eigenvalue for random pure states of bipartite systems, denoted as A and B, is computed analytically using a Coulomb gas method. It is shown that this probability, for large N, goes as exp[-βN^{2}Φ(ζ)], where the parameter β is the Dyson index of the ensemble, ζ is the large deviation parameter, while the rate function Φ(ζ) is calculated exactly. Corresponding equilibrium Coulomb charge density is derived for its large deviations. Effects of the large deviations of the extreme (largest and smallest) Schmidt eigenvalues on the bipartite entanglement are studied using the von Neumann entropy. Effect of these deviations is also studied on the entanglement between subsystems 1 and 2, obtained by further partitioning the subsystem A, using the properties of the density matrix's partial transpose ρ_{12}^{Γ}. The density of states of ρ_{12}^{Γ} is found to be close to the Wigner's semicircle law with these large deviations. The entanglement properties are captured very well by a simple random matrix model for the partial transpose. The model predicts the entanglement transition across a critical large deviation parameter ζ. Log negativity is used to quantify the entanglement between subsystems 1 and 2. Analytical formulas for it are derived using the simple model. Numerical simulations are in excellent agreement with the analytical results.

PRODUCTION AND BIOLOGICAL SIGNIFICANCE OF METHYLATED TRIVALENT ARSENICALS

EPA Science Inventory

PRODUCTION AND BIOLOGICAL SIGNIFICANCE OF METHYLATED TRIVALENT ARSENICALS

Miroslav Styblo1,2,*, Zuzana Drobna1, Felecia S. Walton1, Ilona Jaspers1,2, Shan Lin3,
Stephen B. Waters3, David J. Thomas4

1Department of Pediatrics, 2Center for Environmental Medicine an...

Production of dissolved organic carbon enriched in deoxy sugars representing an additional sink for biological C drawdown in the Amazon River plume

NASA Astrophysics Data System (ADS)

Meador, Travis B.; Aluwihare, Lihini I.

2014-10-01

In North Atlantic waters impacted by discharges from the Amazon and Orinoco Rivers, where planktonic diatom-diazotroph associations (DDA) were active, we observed that an average (± standard deviation) of 61 ± 12% of the biological drawdown of dissolved inorganic carbon (DIC) was partitioned into the accumulating total organic carbon pool, representing a flux of up to 9 ± 4 Tg C yr-1. This drawdown corresponded with chemical alteration of ultrafiltered dissolved organic matter (UDOM), including increases in stable C isotopic composition (δ13C) and C:N. The dissolved carbohydrate component of UDOM also increased with biological DIC drawdown and diatom-associated diazotroph (i.e., Richelia) abundance. New carbohydrates could be distinguished by distinctively high relative abundances of deoxy sugars (up to 55% of monosaccharides), which may promote aggregate formation and enhance vertical carbon export. The identified production of non-Redfieldian, C-enriched UDOM thus suggests a mechanism to explain enhanced C sequestration associated with DDA N2 fixation, which may be widespread in mesohaline environments.

Analysis of form deviation in non-isothermal glass molding

NASA Astrophysics Data System (ADS)

Kreilkamp, H.; Grunwald, T.; Dambon, O.; Klocke, F.

2018-02-01

Especially in the market of sensors, LED lighting and medical technologies, there is a growing demand for precise yet low-cost glass optics. This demand poses a major challenge for glass manufacturers who are confronted with the challenge arising from the trend towards ever-higher levels of precision combined with immense pressure on market prices. Since current manufacturing technologies especially grinding and polishing as well as Precision Glass Molding (PGM) are not able to achieve the desired production costs, glass manufacturers are looking for alternative technologies. Non-isothermal Glass Molding (NGM) has been shown to have a big potential for low-cost mass manufacturing of complex glass optics. However, the biggest drawback of this technology at the moment is the limited accuracy of the manufactured glass optics. This research is addressing the specific challenges of non-isothermal glass molding with respect to form deviation of molded glass optics. Based on empirical models, the influencing factors on form deviation in particular form accuracy, waviness and surface roughness will be discussed. A comparison with traditional isothermal glass molding processes (PGM) will point out the specific challenges of non-isothermal process conditions. Furthermore, the underlying physical principle leading to the formation of form deviations will be analyzed in detail with the help of numerical simulation. In this way, this research contributes to a better understanding of form deviations in non-isothermal glass molding and is an important step towards new applications demanding precise yet low-cost glass optics.

22 CFR 226.4 - Deviations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Deviations. 226.4 Section 226.4 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT ADMINISTRATION OF ASSISTANCE AWARDS TO U.S. NON-GOVERNMENTAL ORGANIZATIONS General § 226.4 Deviations. The Office of Management and Budget (OMB) may grant exceptions for...

34 CFR 74.4 - Deviations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Deviations. 74.4 Section 74.4 Education Office of the Secretary, Department of Education ADMINISTRATION OF GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS General § 74.4 Deviations. The Secretary, after...

22 CFR 145.4 - Deviations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Deviations. 145.4 Section 145.4 Foreign Relations DEPARTMENT OF STATE CIVIL RIGHTS GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS General § 145.4 Deviations. The Office of Management and...

21 CFR 510.4 - Biologics; products subject to license control.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Biologics; products subject to license control. 510.4 Section 510.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS General Provisions § 510.4...

Synthetic Biological Approaches to Natural Product Biosynthesis

PubMed Central

Winter, Jaclyn M; Tang, Yi

2012-01-01

Small molecules produced in Nature continue to be an inspiration for the development of new therapeutic agents. These natural products possess exquisite chemical diversity, which gives rise to their wide range of biological activities. In their host organism, natural products are assembled and modified by dedicated biosynthetic pathways that Nature has meticulously developed. Often times, the complex structures or chemical modifications instated by these pathways are difficult to replicate using traditional synthetic methods. An alternative approach for creating or enhancing the structural variation of natural products is through combinatorial biosynthesis. By rationally reprogramming and manipulating the biosynthetic machinery responsible for their production, unnatural metabolites that were otherwise inaccessible can be obtained. Additionally, new chemical structures can be synthesized or derivatized by developing the enzymes that carry out these complicated chemical reactions into biocatalysts. In this review, we will discuss a variety of combinatorial biosynthetic strategies, their technical challenges, and highlight some recent (since 2007) examples of rationally designed unnatural metabolites, as well as platforms that have been established for the production and modification of clinically important pharmaceutical compounds. PMID:22221832

The Standard Deviation of Launch Vehicle Environments

NASA Technical Reports Server (NTRS)

Yunis, Isam

2005-01-01

Statistical analysis is used in the development of the launch vehicle environments of acoustics, vibrations, and shock. The standard deviation of these environments is critical to accurate statistical extrema. However, often very little data exists to define the standard deviation and it is better to use a typical standard deviation than one derived from a few measurements. This paper uses Space Shuttle and expendable launch vehicle flight data to define a typical standard deviation for acoustics and vibrations. The results suggest that 3dB is a conservative and reasonable standard deviation for the source environment and the payload environment.

Biological production of ethanol from coal

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

Not Available

Due to the abundant supply of coal in the United States, significant research efforts have occurred over the past 15 years concerning the conversion of coal to liquid fuels. Researchers at the University of Arkansas have concentrated on a biological approach to coal liquefaction, starting with coal-derived synthesis gas as the raw material. Synthesis gas, a mixture of CO, H[sub 2], CO[sub 2], CH[sub 4] and sulfur gases, is first produced using traditional gasification techniques. The CO, CO[sub 2] and H[sub 2] are then converted to ethanol using a bacterial culture of Clostridium 1jungdahlii. Ethanol is the desired product ifmore » the resultant product stream is to be used as a liquid fuel. However, under normal operating conditions, the wild strain'' produces acetate in favor of ethanol in conjunction with growth in a 20:1 molar ratio. Research was performed to determine the conditions necessary to maximize not only the ratio of ethanol to acetate, but also to maximize the concentration of ethanol resulting in the product stream.« less

32 CFR 21.645 - Deviation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 1 2010-07-01 2010-07-01 false Deviation. 21.645 Section 21.645 National Defense Department of Defense OFFICE OF THE SECRETARY OF DEFENSE DoD GRANT AND AGREEMENT REGULATIONS DoD GRANTS AND AGREEMENTS-GENERAL MATTERS Definitions § 21.645 Deviation. The issuance or use of a policy or...

32 CFR 21.645 - Deviation.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 1 2014-07-01 2014-07-01 false Deviation. 21.645 Section 21.645 National Defense Department of Defense OFFICE OF THE SECRETARY OF DEFENSE DoD GRANT AND AGREEMENT REGULATIONS DoD GRANTS AND AGREEMENTS-GENERAL MATTERS Definitions § 21.645 Deviation. The issuance or use of a policy or...

32 CFR 21.645 - Deviation.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 1 2011-07-01 2011-07-01 false Deviation. 21.645 Section 21.645 National Defense Department of Defense OFFICE OF THE SECRETARY OF DEFENSE DoD GRANT AND AGREEMENT REGULATIONS DoD GRANTS AND AGREEMENTS-GENERAL MATTERS Definitions § 21.645 Deviation. The issuance or use of a policy or...

32 CFR 21.645 - Deviation.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 1 2012-07-01 2012-07-01 false Deviation. 21.645 Section 21.645 National Defense Department of Defense OFFICE OF THE SECRETARY OF DEFENSE DoD GRANT AND AGREEMENT REGULATIONS DoD GRANTS AND AGREEMENTS-GENERAL MATTERS Definitions § 21.645 Deviation. The issuance or use of a policy or...

32 CFR 21.645 - Deviation.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 1 2013-07-01 2013-07-01 false Deviation. 21.645 Section 21.645 National Defense Department of Defense OFFICE OF THE SECRETARY OF DEFENSE DoD GRANT AND AGREEMENT REGULATIONS DoD GRANTS AND AGREEMENTS-GENERAL MATTERS Definitions § 21.645 Deviation. The issuance or use of a policy or...

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...

21 CFR 510.4 - Biologics; products subject to license control.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS General Provisions § 510.4 Biologics; products subject to license control. An animal drug produced and distributed in full conformance with the animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et seq. ) and...

Waste water biological purification plants of dairy products industry and energy management

NASA Astrophysics Data System (ADS)

Stepanov, Sergey; Solkina, Olga; Stepanov, Alexander; Zhukova, Maria

2017-10-01

The paper presents results of engineering and economical comparison of waste water biological purification plants of dairy products industry. Three methods of purification are compared: traditional biological purification with the use of secondary clarifiers and afterpurification through granular-bed filters, biomembrane technology and physical-and-chemical treatment together with biomembrane technology for new construction conditions. The improvement of the biological purification technology using nitro-denitrification and membrane un-mixing of sludge mixture is a promising trend in this area. In these calculations, an energy management which is widely applied abroad was used. The descriptions of the three methods are illustrated with structural schemes. Costs of equipment and production areas are taken from manufacturers’ data. The research is aimed at an engineering and economical comparison of new constructions of waste water purification of dairy products industry. The experiment demonstrates advantages of biomembrane technology in waste water purification. This technology offers prospects of 122 million rubles cost saving during 25 years of operation when compared with of the technology of preparatory reagent flotation and of 13.7 million rubles cost saving compared to the option of traditional biological purification.

New approaches to estimation of peat deposits for production of biologically active compounds

NASA Astrophysics Data System (ADS)

Stepchenko, L. M.; Yurchenko, V. I.; Krasnik, V. G.; Syedykh, N. J.

2009-04-01

It is known, that biologically active preparations from peat increase animals productivity as well as resistance against stress-factors and have adaptogeneous, antioxidant, immunomodulative properties. Optymal choice of peat deposits for the production of biologically active preparations supposes the detailed comparative analysis of peat properties from different deposits. For this the cadastre of peat of Ukraine is developed in the humic substances laboratory named after prof. Khristeva L.A. (Dnipropetrovsk Agrarian University, Ukraine). It based on the research of its physical and chemical properties, toxicity and biological activity, and called Biocadastre. The Biocadastre is based on the set of parameters, including the descriptions of physical and chemical properties (active acidity, degree of decomposition, botanical composition etc.), toxicity estimation (by parabyotyc, infusorial, inhibitor and other tests), biological activity indexes (growth-promoting, antioxidative, adaptogeneous, immunomodulative antistress and other actions). The blocks of Biocadastre indexes are differentiated, taking into account their use for creation the preparations for vegetable, animals and microorganisms. The Biocadastre will allow to choose the peat deposits, most suitable for the production of different biologically active preparations, both wide directed and narrow spectrum of action, depending on application fields (medicine, agriculture, veterinary medicine, microbiological industry, balneology, cosmetology).

9 CFR 113.53 - Requirements for ingredients of animal origin used for production of biologics.

Code of Federal Regulations, 2014 CFR

2014-01-01

... (African green monkey kidney) cell line and of primary cells or a cell line of the same species of origin... origin used for production of biologics. 113.53 Section 113.53 Animals and Animal Products ANIMAL AND... ingredients of animal origin used for production of biologics. Each lot of ingredient of animal origin which...

9 CFR 113.53 - Requirements for ingredients of animal origin used for production of biologics.

Code of Federal Regulations, 2013 CFR

2013-01-01

... (African green monkey kidney) cell line and of primary cells or a cell line of the same species of origin... origin used for production of biologics. 113.53 Section 113.53 Animals and Animal Products ANIMAL AND... ingredients of animal origin used for production of biologics. Each lot of ingredient of animal origin which...

9 CFR 113.53 - Requirements for ingredients of animal origin used for production of biologics.

Code of Federal Regulations, 2012 CFR

2012-01-01

... (African green monkey kidney) cell line and of primary cells or a cell line of the same species of origin... origin used for production of biologics. 113.53 Section 113.53 Animals and Animal Products ANIMAL AND... ingredients of animal origin used for production of biologics. Each lot of ingredient of animal origin which...

9 CFR 318.308 - Deviations in processing.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) Deviations in processing (or process deviations) must be handled according to: (1)(i) A HACCP plan for canned...) of this section. (c) [Reserved] (d) Procedures for handling process deviations where the HACCP plan... accordance with the following procedures: (a) Emergency stops. (1) When retort jams or breakdowns occur...

Informed consent should be obtained from patients to use products (skin substitutes) and dressings containing biological material.

PubMed

Enoch, S; Shaaban, H; Dunn, K W

2005-01-01

Biological products (tissue engineered skin, allograft and xenograft, and biological dressings) are widely used in the treatment of burns, chronic wounds, and other forms of acute injury. However, the religious and ethical issues, including consent, arising from their use have never been addressed in the medical literature. This study was aimed to ascertain the views of religious leaders about the acceptability of biological products and to evaluate awareness among healthcare professionals about their constituents. The religious groups that make up about 75% of the United Kingdom population were identified and a questionnaire on 11 biological products was sent to its leaders. Another questionnaire concerning 17 products (11 biological and 6 synthetic dressings) was sent to 100 healthcare professionals working in seven specialist units in the UK. All religious leaders (100% response rate) replied, some after consultation with international bodies. Among them, 77% said that patients should be informed of the constituents of the biological products and consent obtained. Some leaders expressed concerns about particular products including the transmission of viral and prion diseases, cruelty to animals, and material derived from neonates. None of the healthcare professionals (73% response rate) surveyed knew the constituents of all the products correctly. Ignoring religious sensitivities and neglecting consent in the usage of biological products could have very serious implications, including litigation. Hospitals and manufacturers should take immediate measures to enlighten healthcare professionals of the constituents of these products so that they can obtain informed consent from patients.

Presence and biological activity of antibiotics used in fuel ethanol and corn co-product production.

PubMed

Compart, D M Paulus; Carlson, A M; Crawford, G I; Fink, R C; Diez-Gonzalez, F; Dicostanzo, A; Shurson, G C

2013-05-01

Antibiotics are used in ethanol production to control bacteria from competing with yeast for nutrients during starch fermentation. However, there is no published scientific information on whether antibiotic residues are present in distillers grains (DG), co-products from ethanol production, or whether they retain their biological activity. Therefore, the objectives of this study were to quantify concentrations of various antibiotic residues in DG and determine whether residues were biologically active. Twenty distillers wet grains and 20 distillers dried grains samples were collected quarterly from 9 states and 43 ethanol plants in the United States. Samples were analyzed for DM, CP, NDF, crude fat, S, P, and pH to describe the nutritional characteristics of the samples evaluated. Samples were also analyzed for the presence of erythromycin, penicillin G, tetracycline, tylosin, and virginiamycin M1, using liquid chromatography and mass spectrometry. Additionally, virginiamycin residues were determined, using a U.S. Food and Drug Administration-approved bioassay method. Samples were extracted and further analyzed for biological activity by exposing the sample extracts to 10(4) to 10(7) CFU/mL concentrations of sentinel bacterial strains Escherichia coli ATCC 8739 and Listeria monocytogenes ATCC 19115. Extracts that inhibited bacterial growth were considered to have biological activity. Physiochemical characteristics varied among samples but were consistent with previous findings. Thirteen percent of all samples contained low (≤1.12 mg/kg) antibiotic concentrations. Only 1 sample extract inhibited growth of Escherichia coli at 10(4) CFU/mL, but this sample contained no detectable concentrations of antibiotic residues. No extracts inhibited Listeria monocytogenes growth. These data indicate that the likelihood of detectable concentrations of antibiotic residues in DG is low; and if detected, they are found in very low concentrations. The inhibition in only 1 DG

Recent advances in the biological production of mannitol.

PubMed

Song, Seung Hoon; Vieille, Claire

2009-08-01

Mannitol is a fructose-derived, 6-carbon sugar alcohol that is widely found in bacteria, yeasts, fungi, and plants. Because of its desirable properties, mannitol has many applications in pharmaceutical products, in the food industry, and in medicine. The current mannitol chemical manufacturing process yields crystalline mannitol in yields below 20 mol% from 50% glucose/50% fructose syrups. Thus, microbial and enzymatic mannitol manufacturing methods have been actively investigated, in particular in the last 10 years. This review summarizes the most recent advances in biological mannitol production, including the development of bacterial-, yeast-, and enzyme-based transformations.

Unification of small and large time scales for biological evolution: deviations from power law.

PubMed

Chowdhury, Debashish; Stauffer, Dietrich; Kunwar, Ambarish

2003-02-14

We develop a unified model that describes both "micro" and "macro" evolutions within a single theoretical framework. The ecosystem is described as a dynamic network; the population dynamics at each node of this network describes the "microevolution" over ecological time scales (i.e., birth, ageing, and natural death of individual organisms), while the appearance of new nodes, the slow changes of the links, and the disappearance of existing nodes accounts for the "macroevolution" over geological time scales (i.e., the origination, evolution, and extinction of species). In contrast to several earlier claims in the literature, we observe strong deviations from power law in the regime of long lifetimes.

Adapting viral safety assurance strategies to continuous processing of biological products.

PubMed

Johnson, Sarah A; Brown, Matthew R; Lute, Scott C; Brorson, Kurt A

2017-01-01

There has been a recent drive in commercial large-scale production of biotechnology products to convert current batch mode processing to continuous processing manufacturing. There have been reports of model systems capable of adapting and linking upstream and downstream technologies into a continuous manufacturing pipeline. However, in many of these proposed continuous processing model systems, viral safety has not been comprehensively addressed. Viral safety and detection is a highly important and often expensive regulatory requirement for any new biological product. To ensure success in the adaption of continuous processing to large-scale production, there is a need to consider the development of approaches that allow for seamless incorporation of viral testing and clearance/inactivation methods. In this review, we outline potential strategies to apply current viral testing and clearance/inactivation technologies to continuous processing, as well as modifications of existing unit operations to ensure the successful integration of viral clearance into the continuous processing of biological products. Biotechnol. Bioeng. 2017;114: 21-32. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Biological hydrogen production by dark fermentation: challenges and prospects towards scaled-up production.

PubMed

RenNanqi; GuoWanqian; LiuBingfeng; CaoGuangli; DingJie

2011-06-01

Among different technologies of hydrogen production, bio-hydrogen production exhibits perhaps the greatest potential to replace fossil fuels. Based on recent research on dark fermentative hydrogen production, this article reviews the following aspects towards scaled-up application of this technology: bioreactor development and parameter optimization, process modeling and simulation, exploitation of cheaper raw materials and combining dark-fermentation with photo-fermentation. Bioreactors are necessary for dark-fermentation hydrogen production, so the design of reactor type and optimization of parameters are essential. Process modeling and simulation can help engineers design and optimize large-scale systems and operations. Use of cheaper raw materials will surely accelerate the pace of scaled-up production of biological hydrogen. And finally, combining dark-fermentation with photo-fermentation holds considerable promise, and has successfully achieved maximum overall hydrogen yield from a single substrate. Future development of bio-hydrogen production will also be discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

Natural products with health benefits from marine biological resources

USDA-ARS?s Scientific Manuscript database

The ocean is the cradle of lives, which provides a diverse array of intriguing natural products that has captured scientists’ attention in the past few decades due to their significant and extremely potent biological activities. In addition to being rich sources for pharmaceutical drugs, marine nat...

Natural product synthesis at the interface of chemistry and biology

PubMed Central

2014-01-01

Nature has evolved to produce unique and diverse natural products that possess high target affinity and specificity. Natural products have been the richest sources for novel modulators of biomolecular function. Since the chemical synthesis of urea by Wöhler, organic chemists have been intrigued by natural products, leading to the evolution of the field of natural product synthesis over the past two centuries. Natural product synthesis has enabled natural products to play an essential role in drug discovery and chemical biology. With the introduction of novel, innovative concepts and strategies for synthetic efficiency, natural product synthesis in the 21st century is well poised to address the challenges and complexities faced by natural product chemistry and will remain essential to progress in biomedical sciences. PMID:25043880

Biological treatment of chicken feather waste for improved biogas production.

PubMed

Forgács, Gergely; Alinezhad, Saeid; Mirabdollah, Amir; Feuk-Lagerstedt, Elisabeth; Horváth, Ilona Sárvári

2011-01-01

A two-stage system was developed which combines the biological degradation of keratin-rich waste with the production of biogas. Chicken feather waste was treated biologically with a recombinant Bacillus megaterium strain showing keratinase activity prior to biogas production. Chopped, autoclaved chicken feathers (4%, W/V) were completely degraded, resulting in a yellowish fermentation broth with a level of 0.51 mg/mL soluble proteins after 8 days of cultivation of the recombinant strain. During the subsequent anaerobic batch digestion experiments, methane production of 0.35 Nm3/kg dry feathers (i.e., 0.4 Nm3/kg volatile solids of feathers), corresponding to 80% of the theoretical value on proteins, was achieved from the feather hydrolyzates, independently of the pre-hydrolysis time period of 1, 2 or 8 days. Cultivation with a native keratinase producing strain, Bacillus licheniformis resulted in only 0.25 mg/mL soluble proteins in the feather hydrolyzate, which then was digested achieving a maximum accumulated methane production of 0.31 Nm3/kg dry feathers. Feather hydrolyzates treated with the wild type B. megaterium produced 0.21 Nm3 CH4/kg dry feathers as maximum yield.

Retention of Preservative Levels of Formaldehyde in Desiccated Biological Products

PubMed Central

Pemberton, John R.

1975-01-01

Concentrations ranging from 8 to 100% of the preservative level of formalin (37% formaldehyde solution) were retained by desiccated biologics, with most products retaining about 50% regardless of the amount originally present. PMID:972183

Introducing the Mean Absolute Deviation "Effect" Size

ERIC Educational Resources Information Center

Gorard, Stephen

2015-01-01

This paper revisits the use of effect sizes in the analysis of experimental and similar results, and reminds readers of the relative advantages of the mean absolute deviation as a measure of variation, as opposed to the more complex standard deviation. The mean absolute deviation is easier to use and understand, and more tolerant of extreme…

48 CFR 2901.404 - Class deviations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... through the Director, DAMS. (b) Requests for deviations under paragraph (a) of this section must be... contracting actions which will be affected. (c) For a FAR class deviation the Director, DAMS will consult with... Director, DAMS as required in FAR 1.404. ...

48 CFR 2901.404 - Class deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... through the Director, DAMS. (b) Requests for deviations under paragraph (a) of this section must be... contracting actions which will be affected. (c) For a FAR class deviation the Director, DAMS will consult with... Director, DAMS as required in FAR 1.404. ...

Role of the standard deviation in the estimation of benchmark doses with continuous data.

PubMed

Gaylor, David W; Slikker, William

2004-12-01

For continuous data, risk is defined here as the proportion of animals with values above a large percentile, e.g., the 99th percentile or below the 1st percentile, for the distribution of values among control animals. It is known that reducing the standard deviation of measurements through improved experimental techniques will result in less stringent (higher) doses for the lower confidence limit on the benchmark dose that is estimated to produce a specified risk of animals with abnormal levels for a biological effect. Thus, a somewhat larger (less stringent) lower confidence limit is obtained that may be used as a point of departure for low-dose risk assessment. It is shown in this article that it is important for the benchmark dose to be based primarily on the standard deviation among animals, s(a), apart from the standard deviation of measurement errors, s(m), within animals. If the benchmark dose is incorrectly based on the overall standard deviation among average values for animals, which includes measurement error variation, the benchmark dose will be overestimated and the risk will be underestimated. The bias increases as s(m) increases relative to s(a). The bias is relatively small if s(m) is less than one-third of s(a), a condition achieved in most experimental designs.

Fidelity deviation in quantum teleportation

NASA Astrophysics Data System (ADS)

Bang, Jeongho; Ryu, Junghee; Kaszlikowski, Dagomir

2018-04-01

We analyze the performance of quantum teleportation in terms of average fidelity and fidelity deviation. The average fidelity is defined as the average value of the fidelities over all possible input states and the fidelity deviation is their standard deviation, which is referred to as a concept of fluctuation or universality. In the analysis, we find the condition to optimize both measures under a noisy quantum channel—we here consider the so-called Werner channel. To characterize our results, we introduce a 2D space defined by the aforementioned measures, in which the performance of the teleportation is represented as a point with the channel noise parameter. Through further analysis, we specify some regions drawn for different channel conditions, establishing the connection to the dissimilar contributions of the entanglement to the teleportation and the Bell inequality violation.

Sustained climate warming drives declining marine biological productivity

NASA Astrophysics Data System (ADS)

Moore, J. Keith; Fu, Weiwei; Primeau, Francois; Britten, Gregory L.; Lindsay, Keith; Long, Matthew; Doney, Scott C.; Mahowald, Natalie; Hoffman, Forrest; Randerson, James T.

2018-03-01

Climate change projections to the year 2100 may miss physical-biogeochemical feedbacks that emerge later from the cumulative effects of climate warming. In a coupled climate simulation to the year 2300, the westerly winds strengthen and shift poleward, surface waters warm, and sea ice disappears, leading to intense nutrient trapping in the Southern Ocean. The trapping drives a global-scale nutrient redistribution, with net transfer to the deep ocean. Ensuing surface nutrient reductions north of 30°S drive steady declines in primary production and carbon export (decreases of 24 and 41%, respectively, by 2300). Potential fishery yields, constrained by lower–trophic-level productivity, decrease by more than 20% globally and by nearly 60% in the North Atlantic. Continued high levels of greenhouse gas emissions could suppress marine biological productivity for a millennium.

48 CFR 1401.403 - Individual deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Individual deviations. 1401.403 Section 1401.403 Federal Acquisition Regulations System DEPARTMENT OF THE INTERIOR GENERAL DEPARTMENT OF THE INTERIOR ACQUISITION REGULATION SYSTEM Deviations from the FAR and DIAR 1401.403 Individual...

9 CFR 113.29 - Determination of moisture content in desiccated biological products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Determination of moisture content in desiccated biological products. 113.29 Section 113.29 Animals and Animal Products ANIMAL AND PLANT HEALTH... as “A.” (iii) Return weighing bottles to the desiccator. (2) Remove the sample container seal. (i...

9 CFR 113.29 - Determination of moisture content in desiccated biological products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Determination of moisture content in desiccated biological products. 113.29 Section 113.29 Animals and Animal Products ANIMAL AND PLANT HEALTH... as “A.” (iii) Return weighing bottles to the desiccator. (2) Remove the sample container seal. (i...

Mapping the patent landscape of synthetic biology for fine chemical production pathways.

PubMed

Carbonell, Pablo; Gök, Abdullah; Shapira, Philip; Faulon, Jean-Loup

2016-09-01

A goal of synthetic biology bio-foundries is to innovate through an iterative design/build/test/learn pipeline. In assessing the value of new chemical production routes, the intellectual property (IP) novelty of the pathway is important. Exploratory studies can be carried using knowledge of the patent/IP landscape for synthetic biology and metabolic engineering. In this paper, we perform an assessment of pathways as potential targets for chemical production across the full catalogue of reachable chemicals in the extended metabolic space of chassis organisms, as computed by the retrosynthesis-based algorithm RetroPath. Our database for reactions processed by sequences in heterologous pathways was screened against the PatSeq database, a comprehensive collection of more than 150M sequences present in patent grants and applications. We also examine related patent families using Derwent Innovations. This large-scale computational study provides useful insights into the IP landscape of synthetic biology for fine and specialty chemicals production. © 2016 The Authors. Microbial Biotechnology published by John Wiley & Sons Ltd and Society for Applied Microbiology.

Natural product synthesis at the interface of chemistry and biology.

PubMed

Hong, Jiyong

2014-08-11

Nature has evolved to produce unique and diverse natural products that possess high target affinity and specificity. Natural products have been the richest sources for novel modulators of biomolecular function. Since the chemical synthesis of urea by Wöhler, organic chemists have been intrigued by natural products, leading to the evolution of the field of natural product synthesis over the past two centuries. Natural product synthesis has enabled natural products to play an essential role in drug discovery and chemical biology. With the introduction of novel, innovative concepts and strategies for synthetic efficiency, natural product synthesis in the 21st century is well poised to address the challenges and complexities faced by natural product chemistry and will remain essential to progress in biomedical sciences. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

41 CFR 115-1.110 - Deviations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Deviations. 115-1.110 Section 115-1.110 Public Contracts and Property Management Federal Property Management Regulations System (Continued) ENVIRONMENTAL PROTECTION AGENCY 1-INTRODUCTION 1.1-Regulation System § 115-1.110 Deviations...

Large deviation analysis of a simple information engine

NASA Astrophysics Data System (ADS)

Maitland, Michael; Grosskinsky, Stefan; Harris, Rosemary J.

2015-11-01

Information thermodynamics provides a framework for studying the effect of feedback loops on entropy production. It has enabled the understanding of novel thermodynamic systems such as the information engine, which can be seen as a modern version of "Maxwell's Dæmon," whereby a feedback controller processes information gained by measurements in order to extract work. Here, we analyze a simple model of such an engine that uses feedback control based on measurements to obtain negative entropy production. We focus on the distribution and fluctuations of the information obtained by the feedback controller. Significantly, our model allows an analytic treatment for a two-state system with exact calculation of the large deviation rate function. These results suggest an approximate technique for larger systems, which is corroborated by simulation data.

Systems Biology of Recombinant Protein Production in Bacillus megaterium

NASA Astrophysics Data System (ADS)

Biedendieck, Rebekka; Bunk, Boyke; Fürch, Tobias; Franco-Lara, Ezequiel; Jahn, Martina; Jahn, Dieter

Over the last two decades the Gram-positive bacterium Bacillus megaterium was systematically developed to a useful alternative protein production host. Multiple vector systems for high yield intra- and extracellular protein production were constructed. Strong inducible promoters were combined with DNA sequences for optimised ribosome binding sites, various leader peptides for protein export and N- as well as C-terminal affinity tags for affinity chromatographic purification of the desired protein. High cell density cultivation and recombinant protein production were successfully tested. For further system biology based control and optimisation of the production process the genomes of two B. megaterium strains were completely elucidated, DNA arrays designed, proteome, fluxome and metabolome analyses performed and all data integrated using the bioinformatics platform MEGABAC. Now, solid theoretical and experimental bases for primary modeling attempts of the production process are available.

41 CFR 101-1.110 - Deviation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 2 2010-07-01 2010-07-01 true Deviation. 101-1.110 Section 101-1.110 Public Contracts and Property Management Federal Property Management Regulations System FEDERAL PROPERTY MANAGEMENT REGULATIONS GENERAL 1-INTRODUCTION 1.1-Regulation System § 101-1.110 Deviation...

41 CFR 105-1.110 - Deviation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Deviation. 105-1.110 Section 105-1.110 Public Contracts and Property Management Federal Property Management Regulations System (Continued) GENERAL SERVICES ADMINISTRATION 1-INTRODUCTION 1.1-Regulations System § 105-1.110 Deviation. (a...

Acute myocardial infarction with changing axis deviation.

PubMed

Patanè, Salvatore; Marte, Filippo

2011-07-01

Changing axis deviation has been rarely reported also during atrial fibrillation or atrial flutter. Changing axis deviation has been rarely reported also during acute myocardial infarction associated with atrial fibrillation. Isolated left posterior hemiblock is a very rare finding but the evidence of transient right axis deviation with a left posterior hemiblock pattern has been reported during acute anterior myocardial infarction as related with significant right coronary artery obstruction and collateral circulation between the left coronary system and the posterior descending artery. Left anterior hemiblock development during acute inferior myocardial infarction can be an indicator of left anterior descending coronary artery lesions, multivessel coronary artery disease, and impaired left ventricular systolic function. We present a case of changing axis deviation in a 62-year-old Italian man with acute myocardial infarction. Also this case focuses attention on changing axis deviation during acute myocardial infarction. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

Perceptions of midline deviations among different facial types.

PubMed

Williams, Ryan P; Rinchuse, Daniel J; Zullo, Thomas G

2014-02-01

The correction of a deviated midline can involve complicated mechanics and a protracted treatment. The threshold below which midline deviations are considered acceptable might depend on multiple factors. The objective of this study was to evaluate the effect of facial type on laypersons' perceptions of various degrees of midline deviation. Smiling photographs of male and female subjects were altered to create 3 facial type variations (euryprosopic, mesoprosopic, and leptoprosopic) and deviations in the midline ranging from 0.0 to 4.0 mm. Evaluators rated the overall attractiveness and acceptability of each photograph. Data were collected from 160 raters. The overall threshold for the acceptability of a midline deviation was 2.92 ± 1.10 mm, with the threshold for the male subject significantly lower than that for the female subject. The euryprosopic facial type showed no decrease in mean attractiveness until the deviations were 2 mm or more. All other facial types were rated as decreasingly attractive from 1 mm onward. Among all facial types, the attractiveness of the male subject was only affected at deviations of 2 mm or greater; for the female subject, the attractiveness scores were significantly decreased at 1 mm. The mesoprosopic facial type was most attractive for the male subject but was the least attractive for the female subject. Facial type and sex may affect the thresholds at which a midline deviation is detected and above which a midline deviation is considered unacceptable. Both the euryprosopic facial type and male sex were associated with higher levels of attractiveness at relatively small levels of deviations. Copyright © 2014 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Advanced glycation end-products: a biological consequence of lifestyle contributing to cancer disparity

PubMed Central

Turner, David P.

2015-01-01

Low income, poor diet, obesity and a lack of exercise are inter-related lifestyle factors that can profoundly alter our biological make-up to increase cancer risk, growth and development. We recently reported a potential mechanistic link between carbohydrate derived metabolites and cancer which may provide a biological consequence of lifestyle that can directly impact tumor biology. Advanced glycation end-products (AGEs) are reactive metabolites produced as a by-product of sugar metabolism. Failure to remove these highly reactive metabolites can lead to protein damage, aberrant cell signaling, increased stress responses, and decreased genetic fidelity. Critically, AGE accumulation is also directly affected by our lifestyle choices and shows a race specific, tumor dependent pattern of accumulation in cancer patients. This review will discuss the contribution of AGEs to the cancer phenotype with a particular emphasis on their biological links with the socioeconomic and environmental risk factors that drive cancer disparity. Given the potential benefits of lifestyle changes and the potential biological role of AGEs in promoting cancer, opportunities exist for collaborations impacting basic, translational, epidemiological and cancer prevention initiatives. PMID:25920350

Sustained climate warming drives declining marine biological productivity

DOE PAGES

Moore, J. Keith; Fu, Weiwei; Primeau, Francois; ...

2018-03-01

Climate change projections to the year 2100 may miss physical-biogeochemical feedbacks that emerge later from the cumulative effects of climate warming. In a coupled climate simulation to the year 2300, the westerly winds strengthen and shift poleward, surface waters warm, and sea ice disappears, leading to intense nutrient trapping in the Southern Ocean. The trapping drives a global-scale nutrient redistribution, with net transfer to the deep ocean. Ensuing surface nutrient reductions north of 30°S drive steady declines in primary production and carbon export (decreases of 24 and 41%, respectively, by 2300). Potential fishery yields, constrained by lower–trophic-level productivity, decrease bymore » more than 20% globally and by nearly 60% in the North Atlantic. Continued high levels of greenhouse gas emissions could suppress marine biological productivity for a millennium.« less

Sustained climate warming drives declining marine biological productivity

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

Moore, J. Keith; Fu, Weiwei; Primeau, Francois

Climate change projections to the year 2100 may miss physical-biogeochemical feedbacks that emerge later from the cumulative effects of climate warming. In a coupled climate simulation to the year 2300, the westerly winds strengthen and shift poleward, surface waters warm, and sea ice disappears, leading to intense nutrient trapping in the Southern Ocean. The trapping drives a global-scale nutrient redistribution, with net transfer to the deep ocean. Ensuing surface nutrient reductions north of 30°S drive steady declines in primary production and carbon export (decreases of 24 and 41%, respectively, by 2300). Potential fishery yields, constrained by lower–trophic-level productivity, decrease bymore » more than 20% globally and by nearly 60% in the North Atlantic. Continued high levels of greenhouse gas emissions could suppress marine biological productivity for a millennium.« less

Spectral relative standard deviation: a practical benchmark in metabolomics.

PubMed

Parsons, Helen M; Ekman, Drew R; Collette, Timothy W; Viant, Mark R

2009-03-01

Metabolomics datasets, by definition, comprise of measurements of large numbers of metabolites. Both technical (analytical) and biological factors will induce variation within these measurements that is not consistent across all metabolites. Consequently, criteria are required to assess the reproducibility of metabolomics datasets that are derived from all the detected metabolites. Here we calculate spectrum-wide relative standard deviations (RSDs; also termed coefficient of variation, CV) for ten metabolomics datasets, spanning a variety of sample types from mammals, fish, invertebrates and a cell line, and display them succinctly as boxplots. We demonstrate multiple applications of spectral RSDs for characterising technical as well as inter-individual biological variation: for optimising metabolite extractions, comparing analytical techniques, investigating matrix effects, and comparing biofluids and tissue extracts from single and multiple species for optimising experimental design. Technical variation within metabolomics datasets, recorded using one- and two-dimensional NMR and mass spectrometry, ranges from 1.6 to 20.6% (reported as the median spectral RSD). Inter-individual biological variation is typically larger, ranging from as low as 7.2% for tissue extracts from laboratory-housed rats to 58.4% for fish plasma. In addition, for some of the datasets we confirm that the spectral RSD values are largely invariant across different spectral processing methods, such as baseline correction, normalisation and binning resolution. In conclusion, we propose spectral RSDs and their median values contained herein as practical benchmarks for metabolomics studies.

Biological parameters used in setting captive-breeding quotas for Indonesia's breeding facilities.

PubMed

Janssen, Jordi; Chng, Serene C L

2018-02-01

The commercial captive breeding of wildlife is often seen as a potential conservation tool to relieve pressure on wild populations, but laundering of wild-sourced specimens as captive bred can seriously undermine conservation efforts and provide a false sense of sustainability. Indonesia is at the center of such controversy; therefore, we examined Indonesia's captive-breeding production plan (CBPP) for 2016. We compared the biological parameters used in the CBPP with parameters in the literature and with parameters suggested by experts on each species and identified shortcomings of the CBPP. Production quotas for 99 out of 129 species were based on inaccurate or unrealistic biological parameters and production quotas deviated more than 10% from what parameters in the literature allow for. For 38 species, the quota exceeded the number of animals that can be bred based on the biological parameters (range 100-540%) calculated with equations in the CBPP. We calculated a lower reproductive output for 88 species based on published biological parameters compared with the parameters used in the CBPP. The equations used in the production plan did not appear to account for other factors (e.g., different survival rate for juveniles compared to adult animals) involved in breeding the proposed large numbers of specimens. We recommend the CBPP be adjusted so that realistic published biological parameters are applied and captive-breeding quotas are not allocated to species if their captive breeding is unlikely to be successful or no breeding stock is available. The shortcomings in the current CBPP create loopholes that mean mammals, reptiles, and amphibians from Indonesia declared captive bred may have been sourced from the wild. © 2017 Society for Conservation Biology.

Deviation Management: Key Management Subsystem Driver of Knowledge-Based Continuous Improvement in the Henry Ford Production System.

PubMed

Zarbo, Richard J; Copeland, Jacqueline R; Varney, Ruan C

2017-10-01

To develop a business subsystem fulfilling International Organization for Standardization 15189 nonconformance management regulatory standard, facilitating employee engagement in problem identification and resolution to effect quality improvement and risk mitigation. From 2012 to 2016, the integrated laboratories of the Henry Ford Health System used a quality technical team to develop and improve a management subsystem designed to identify, track, trend, and summarize nonconformances based on frequency, risk, and root cause for elimination at the level of the work. Programmatic improvements and training resulted in markedly increased documentation culminating in 71,641 deviations in 2016 classified by a taxonomy of 281 defect types into preanalytic (74.8%), analytic (23.6%), and postanalytic (1.6%) testing phases. The top 10 deviations accounted for 55,843 (78%) of the total. Deviation management is a key subsystem of managers' standard work whereby knowledge of nonconformities assists in directing corrective actions and continuous improvements that promote consistent execution and higher levels of performance. © American Society for Clinical Pathology, 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Comparing Standard Deviation Effects across Contexts

ERIC Educational Resources Information Center

Ost, Ben; Gangopadhyaya, Anuj; Schiman, Jeffrey C.

2017-01-01

Studies using tests scores as the dependent variable often report point estimates in student standard deviation units. We note that a standard deviation is not a standard unit of measurement since the distribution of test scores can vary across contexts. As such, researchers should be cautious when interpreting differences in the numerical size of…

9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.

Code of Federal Regulations, 2010 CFR

2010-01-01

... PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL...

Biological sludge solubilisation for reduction of excess sludge production in wastewater treatment process.

PubMed

Yamaguchi, T; Yao, Y; Kihara, Y

2006-01-01

A novel sludge disintegration system (JFE-SD system) was developed for the reduction of excess sludge production in wastewater treatment plants. Chemical and biological treatments were applied to disintegrate excess sludge. At the first step, to enhance biological disintegration, the sludge was pretreated with alkali. At the second step, the sludge was disintegrated by biological treatment. Many kinds of sludge degrading microorganisms integrated the sludge. The efficiency of the new sludge disintegration system was confirmed in a full-scale experiment. The JFE-SD system reduced excess sludge production by approximately 50% during the experimental period. The quality of effluent was kept at quite a good level. Economic analysis revealed that this system could significantly decrease the excess sludge treatment cost.

Transport Coefficients from Large Deviation Functions

NASA Astrophysics Data System (ADS)

Gao, Chloe; Limmer, David

2017-10-01

We describe a method for computing transport coefficients from the direct evaluation of large deviation function. This method is general, relying on only equilibrium fluctuations, and is statistically efficient, employing trajectory based importance sampling. Equilibrium fluctuations of molecular currents are characterized by their large deviation functions, which is a scaled cumulant generating function analogous to the free energy. A diffusion Monte Carlo algorithm is used to evaluate the large deviation functions, from which arbitrary transport coefficients are derivable. We find significant statistical improvement over traditional Green-Kubo based calculations. The systematic and statistical errors of this method are analyzed in the context of specific transport coefficient calculations, including the shear viscosity, interfacial friction coefficient, and thermal conductivity.

Systems Biology of Microbial Exopolysaccharides Production.

PubMed

Ates, Ozlem

2015-01-01

Exopolysaccharides (EPSs) produced by diverse group of microbial systems are rapidly emerging as new and industrially important biomaterials. Due to their unique and complex chemical structures and many interesting physicochemical and rheological properties with novel functionality, the microbial EPSs find wide range of commercial applications in various fields of the economy such as food, feed, packaging, chemical, textile, cosmetics and pharmaceutical industry, agriculture, and medicine. EPSs are mainly associated with high-value applications, and they have received considerable research attention over recent decades with their biocompatibility, biodegradability, and both environmental and human compatibility. However, only a few microbial EPSs have achieved to be used commercially due to their high production costs. The emerging need to overcome economic hurdles and the increasing significance of microbial EPSs in industrial and medical biotechnology call for the elucidation of the interrelations between metabolic pathways and EPS biosynthesis mechanism in order to control and hence enhance its microbial productivity. Moreover, a better understanding of biosynthesis mechanism is a significant issue for improvement of product quality and properties and also for the design of novel strains. Therefore, a systems-based approach constitutes an important step toward understanding the interplay between metabolism and EPS biosynthesis and further enhances its metabolic performance for industrial application. In this review, primarily the microbial EPSs, their biosynthesis mechanism, and important factors for their production will be discussed. After this brief introduction, recent literature on the application of omics technologies and systems biology tools for the improvement of production yields will be critically evaluated. Special focus will be given to EPSs with high market value such as xanthan, levan, pullulan, and dextran.

Systems Biology of Microbial Exopolysaccharides Production

PubMed Central

Ates, Ozlem

2015-01-01

Exopolysaccharides (EPSs) produced by diverse group of microbial systems are rapidly emerging as new and industrially important biomaterials. Due to their unique and complex chemical structures and many interesting physicochemical and rheological properties with novel functionality, the microbial EPSs find wide range of commercial applications in various fields of the economy such as food, feed, packaging, chemical, textile, cosmetics and pharmaceutical industry, agriculture, and medicine. EPSs are mainly associated with high-value applications, and they have received considerable research attention over recent decades with their biocompatibility, biodegradability, and both environmental and human compatibility. However, only a few microbial EPSs have achieved to be used commercially due to their high production costs. The emerging need to overcome economic hurdles and the increasing significance of microbial EPSs in industrial and medical biotechnology call for the elucidation of the interrelations between metabolic pathways and EPS biosynthesis mechanism in order to control and hence enhance its microbial productivity. Moreover, a better understanding of biosynthesis mechanism is a significant issue for improvement of product quality and properties and also for the design of novel strains. Therefore, a systems-based approach constitutes an important step toward understanding the interplay between metabolism and EPS biosynthesis and further enhances its metabolic performance for industrial application. In this review, primarily the microbial EPSs, their biosynthesis mechanism, and important factors for their production will be discussed. After this brief introduction, recent literature on the application of omics technologies and systems biology tools for the improvement of production yields will be critically evaluated. Special focus will be given to EPSs with high market value such as xanthan, levan, pullulan, and dextran. PMID:26734603

Biological Productivity from an Oxygen Mass Balance in the subarctic North Pacific

NASA Astrophysics Data System (ADS)

Giesbrecht, K. E.; Hamme, R. C.

2008-12-01

Biological productivity is an important process controlling the export of carbon into the deep ocean and thus influencing the earth's climate. An O2 mass balance of the upper ocean can estimate this export of organic carbon if the physical processes affecting the O2 concentrations are accounted for. This can be accomplished by measuring the dissolved O2/Ar ratio, because their similar physical properties allow us to consider Ar an 'abiotic' O2 analogue. Here we present a two-year data set of O2/N2/Ar ratio measurements collected at Station Papa and along Line P in 2007/08. Line P, situated in the subarctic North Pacific, is a series of oceanographic stations running from the southwest tip of Vancouver Island to Station Papa (50°N, 145°W), one of the oldest deep-ocean time series in existence which is located in the High-Nutrient/Low-Chlorophyll (HNLC) region of the subarctic gyre. Current cruises along Line P run three times per year, typically in February, June and August. The dissolved gas ratios are measured using a stable isotope mass spectrometer and oxygen concentrations by titration. In a simple steady state, we equate biological O2 production to diffusive gas exchange, using the O2/Ar ratio to normalize the physical component of the oxygen signal and calculate the net biological oxygen production. Diffusive gas exchange is calculated using a wind speed parameterization. Preliminary estimates of the net biological production in the mixed layer at Station Papa for 2007 are calculated at 30.9 and 14.0 mmol C m-2 d- 1 for June and August respectively, both exhibiting mixed layer O2/Ar supersaturations. The O2/Ar undersaturation in the mixed layer for February 2007 suggests net respiration at that time. The wind speed parameterization of diffusive gas exchange is the major source of error for this method. We plan to refine our productivity calculation to account for vertical mixing and also by measuring rates of production using a number of different methods

Photochemical versus biological production of methyl iodide during Meteor 55

NASA Astrophysics Data System (ADS)

Richter, U.; Wallace, D.

2003-04-01

The flux of methyl iodide from sea to air represents the largest flux of iodine from the ocean to the atmosphere. Surface water concentrations and hence fluxes are particularly high in tropical regions. This flux may be responsible for the enrichment of iodine in the marine aerosol and may contribute to important processes in the marine boundary layer, including particle formation. Methyl iodide is commonly referred to as a biogenic gas, with both macroalgae and phytoplankton identified as important sources. On the other hand experimental and field data have shown the importance of photochemical production that is not necessarily associated directly with biological activity. During the Meteor cruise 55 along 11°N in the tropical Atlantic Ocean, a series of experiments were conducted to examine the biological vs. photochemical production of methyl iodide. A total of eight separate experiments were conducted. Production of CH3I in quartz glass flasks during 24 hour incubations (dark and natural sunlight) was measured under three experimental treatments: untreated seawater, filtered seawater (0.1 um pore size filter to exclude most phytoplankton and bacteria), and seawater that was poisoned with mercuric chloride. There were two clear findings from these experiments: (1) methyl iodide production was significantly higher in all the incubations that were exposed to the light than in the dark incubations; (2) there was no significant difference between CH3I production under the three experimental treatments. These results argue very strongly for the primary importance of photochemical production of CH3I as opposed to biogenic production at least for the tropical open ocean surface waters. Further experiments are required to investigate the reactants involved, their sources, the wavelength and depth dependence of production, etc. as well as (possibly related) sink processes.

40 CFR 63.1965 - What is a deviation?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 13 2013-07-01 2012-07-01 true What is a deviation? 63.1965 Section 63.1965 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED... Compliance Requirements § 63.1965 What is a deviation? A deviation is defined in § 63.1990. For the purposes...

PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.

PubMed

Krause, Stephan O

2015-01-01

This paper provides overall guidance and best practices for the setting of specifications for clinical biological drug substances and drug products within the framework of ICH guidelines on pharmaceutical development [Q8(R2) and Q11], quality risk management (Q9), and quality systems (Q10). A review is provided of the current regulatory expectations for the specification setting process as part of a control strategy during product development, pointing to existing challenges for the investigational new drug/investigational medicinal product dossier (IND/IMPD) sponsor. A case study illustrates how the investigational medicinal product specification revision process can be managed within a flexible quality system, and how specifications can be set and justified for early and late development stages. This paper provides an overview for the setting of product specifications for investigational medicinal products used in clinical trials. A case study illustrates how product specifications of investigational medicinal products can be justified and managed within a modern product quality system. © PDA, Inc. 2015.

40 CFR 63.1965 - What is a deviation?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 12 2010-07-01 2010-07-01 true What is a deviation? 63.1965 Section 63.1965 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED... Requirements § 63.1965 What is a deviation? A deviation is defined in § 63.1990. For the purposes of the...

40 CFR 63.1965 - What is a deviation?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 12 2011-07-01 2009-07-01 true What is a deviation? 63.1965 Section 63.1965 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED... Requirements § 63.1965 What is a deviation? A deviation is defined in § 63.1990. For the purposes of the...

Advanced glycation end-products: a biological consequence of lifestyle contributing to cancer disparity.

PubMed

Turner, David P

2015-05-15

Low income, poor diet, obesity, and a lack of exercise are interrelated lifestyle factors that can profoundly alter our biologic make up to increase cancer risk, growth, and development. We recently reported a potential mechanistic link between carbohydrate-derived metabolites and cancer, which may provide a biologic consequence of lifestyle that can directly affect tumor biology. Advanced glycation end-products (AGE) are reactive metabolites produced as a by-product of sugar metabolism. Failure to remove these highly reactive metabolites can lead to protein damage, aberrant cell signaling, increased stress responses, and decreased genetic fidelity. Critically, AGE accumulation is also directly affected by our lifestyle choices and shows a race-specific, tumor-dependent pattern of accumulation in cancer patients. This review will discuss the contribution of AGEs to the cancer phenotype, with a particular emphasis on their biologic links with the socioeconomic and environmental risk factors that drive cancer disparity. Given the potential benefits of lifestyle changes and the potential biologic role of AGEs in promoting cancer, opportunities exist for collaborations affecting basic, translational, epidemiologic, and cancer prevention initiatives. ©2015 American Association for Cancer Research.

33 CFR 155.5012 - Deviation from response plan.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Deviation from response plan. 155... Response Plans § 155.5012 Deviation from response plan. The owner or operator of a nontank vessel required to have a vessel response plan (VRP) under this subpart may not deviate from the approved VRP unless...

Ocean glider observations of iceberg-enhanced biological production in the northwestern Weddell Sea

NASA Astrophysics Data System (ADS)

Biddle, Louise C.; Kaiser, Jan; Heywood, Karen J.; Thompson, Andrew F.; Jenkins, Adrian

2015-01-01

Icebergs affect local biological production around Antarctica. We used an ocean glider to observe the effects of a large iceberg that was advected by the Antarctic Slope Current along the continental slope in the northwestern Weddell Sea in early 2012. The high-resolution glider data reveal a pronounced effect of the iceberg on ocean properties, with oxygen concentrations of (13 ± 4) μmol kg-1 higher than levels in surrounding waters, which are most likely due to positive net community production. This response was confined to three areas of water in the direct vicinity of the iceberg track, each no larger than 2 km2. Our findings suggest that icebergs have an impact on Antarctic production presumably through local micronutrient injections, on a scale smaller than typical satellite observations of biological production in the Southern Ocean.

9 CFR 113.52 - Requirements for cell lines used for production of biologics.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Requirements for cell lines used for... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production of... cell line used to prepare a biological product shall be tested as prescribed in this section. A cell...

9 CFR 113.52 - Requirements for cell lines used for production of biologics.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Requirements for cell lines used for... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production of... cell line used to prepare a biological product shall be tested as prescribed in this section. A cell...

9 CFR 113.52 - Requirements for cell lines used for production of biologics.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Requirements for cell lines used for... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production of... cell line used to prepare a biological product shall be tested as prescribed in this section. A cell...

9 CFR 113.52 - Requirements for cell lines used for production of biologics.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Requirements for cell lines used for... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production of... cell line used to prepare a biological product shall be tested as prescribed in this section. A cell...

9 CFR 113.52 - Requirements for cell lines used for production of biologics.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Requirements for cell lines used for... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production of... cell line used to prepare a biological product shall be tested as prescribed in this section. A cell...

Urine: Waste product or biologically active tissue?

PubMed

2018-03-01

Historically, urine has been viewed primarily as a waste product with little biological role in the overall health of an individual. Increasingly, data suggest that urine plays a role in human health beyond waste excretion. For example, urine might act as an irritant and contribute to symptoms through interaction with-and potential compromise of-the urothelium. To explore the concept that urine may be a vehicle for agents with potential or occult bioactivity and to discuss existing evidence and novel research questions that may yield insight into such a role, the National Institute of Diabetes and Digestive and Kidney Disease invited experts in the fields of comparative evolutionary physiology, basic science, nephrology, urology, pediatrics, metabolomics, and proteomics (among others) to a Urinology Think Tank meeting on February 9, 2015. This report reflects ideas that evolved from this meeting and current literature, including the concept of urine quality, the biological, chemical, and physical characteristics of urine, including the microbiota, cells, exosomes, pH, metabolites, proteins, and specific gravity (among others). Additionally, the manuscript presents speculative, and hopefully testable, ideas about the functional roles of urine constituents in health and disease. Moving forward, there are several questions that need further understanding and pursuit. There were suggestions to consider actively using various animal models and their biological specimens to elaborate on basic mechanistic information regarding human bladder dysfunction. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.

78 FR 12760 - Guidance for Industry on Labeling for Human Prescription Drug and Biological Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-25

...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling for Human Prescription Drug and Biological Products--Implementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear; useful; informative; and to the extent possible, consistent in content and format. It will assist applicants in developing labeling for new products, revising existing labeling, and implementing the requirements on content and format of labeling for human prescription drug and biological products (71 FR 3922), which appeared in the Federal Register of January 24, 2006. The rule is commonly referred to as the ``Physician Labeling Rule'' (PLR) because it addresses prescription drug labeling that is used by prescribers and other health care practitioners.

Changing axis deviation during acute myocardial infarction.

PubMed

Patanè, Salvatore; Marte, Filippo

2010-07-09

Changing axis deviation has been reported during acute myocardial infarction also associated with atrial fibrillation. Isolated left posterior hemiblock is a very rare finding but the evidence of transient right axis deviation with a left posterior hemiblock pattern has been reported during acute anterior myocardial infarction as related with significant right coronary artery obstruction and collateral circulation between the left coronary system and the posterior descending artery. We present a case of changing axis deviation in a 70-year-old Italian man with acute myocardial infarction. Copyright (c) 2008 Elsevier Ireland Ltd. All rights reserved.

Degrees of Freedom for Allan Deviation Estimates of Multiple Clocks

DTIC Science & Technology

2016-04-01

Allan deviation . Allan deviation will be represented by σ and standard deviation will be represented by δ. In practice, when the Allan deviation of a...the Allan deviation of standard noise types. Once the number of degrees of freedom is known, an approximate confidence interval can be assigned by...measurement errors from paired difference data. We extend this approach by using the Allan deviation to estimate the error in a frequency standard

Recent advances on biological production of difructose dianhydride III.

PubMed

Zhu, Yingying; Yu, Shuhuai; Zhang, Wenli; Zhang, Tao; Guang, Cuie; Mu, Wanmeng

2018-04-01

Difructose dianhydride III (DFA III) is a cyclic difructose containing two reciprocal glycosidic linkages. It is easily generated with a small amount by sucrose caramelization and thus occurs in a wide range of food-stuffs during food processing. DFA III has half sweetness but only 1/15 energy of sucrose, showing potential industrial application as low-calorie sucrose substitute. In addition, it displays many benefits including prebiotic effect, low cariogenicity property, and hypocholesterolemic effect, and improves absorption of minerals, flavonoids, and immunoglobulin G. DFA III is biologically produced from inulin by inulin fructotransferase (IFTase, EC 4.2.2.18). Plenty of DFA III-producing enzymes have been identified. The crystal structure of inulin fructotransferase has been determined, and its molecular modification has been performed to improve the catalytic activity and structural stability. Large-scale production of DFA III has been studied by various IFTases, especially using an ultrafiltration membrane bioreactor. In this article, the recent findings on physiological effects of DFA III are briefly summarized; the research progresses on identification, expression, and molecular modification of IFTase and large-scale biological production of DFA III by IFTase are reviewed in detail.

Study of Measurement Strategies of Geometric Deviation of the Position of the Threaded Holes

NASA Astrophysics Data System (ADS)

Drbul, Mário; Martikan, Pavol; Sajgalik, Michal; Czan, Andrej; Broncek, Jozef; Babik, Ondrej

2017-12-01

Verification of product and quality control is an integral part of current production process. In terms of functional requirements and product interoperability, it is necessary to analyze their dimensional and also geometric specifications. Threaded holes are verified elements too, which are a substantial part of detachable screw connections and have a broad presence in engineering products. This paper deals with on the analysing of measurement strategies of verification geometric deviation of the position of the threaded holes, which are the indirect method of measuring threaded pins when applying different measurement strategies which can affect the result of the verification of the product..

Continuous downstream processing for high value biological products: A Review.

PubMed

Zydney, Andrew L

2016-03-01

There is growing interest in the possibility of developing truly continuous processes for the large-scale production of high value biological products. Continuous processing has the potential to provide significant reductions in cost and facility size while improving product quality and facilitating the design of flexible multi-product manufacturing facilities. This paper reviews the current state-of-the-art in separations technology suitable for continuous downstream bioprocessing, focusing on unit operations that would be most appropriate for the production of secreted proteins like monoclonal antibodies. This includes cell separation/recycle from the perfusion bioreactor, initial product recovery (capture), product purification (polishing), and formulation. Of particular importance are the available options, and alternatives, for continuous chromatographic separations. Although there are still significant challenges in developing integrated continuous bioprocesses, recent technological advances have provided process developers with a number of attractive options for development of truly continuous bioprocessing operations. © 2015 Wiley Periodicals, Inc.

Biological-inorganic hybrid systems as a generalized platform for chemical production.

PubMed

Nangle, Shannon N; Sakimoto, Kelsey K; Silver, Pamela A; Nocera, Daniel G

2017-12-01

An expanding renewable energy market to supplant petrochemicals has motivated synthesis technologies that use renewable feedstocks, such as CO 2 . Hybrid biological-inorganic systems provide a sustainable, efficient, versatile, and inexpensive chemical synthesis platform. These systems comprise biocompatible electrodes that transduce electrical energy either directly or indirectly into bioavailable energy, such as H 2 and NAD(P)H. In combination, specific bacteria use these energetic reducing equivalents to fix CO 2 into multi-carbon organic compounds. As hybrid biological-inorganic technologies have developed, the focus has shifted from phenomenological and proof-of-concept discovery towards enhanced energy efficiency, production rate, product scope, and industrial robustness. In this review, we highlight the progress and the state-of-the-art of this field and describe the advantages and challenges involved in designing bio- and chemo- compatible systems. Copyright © 2017 Elsevier Ltd. All rights reserved.

Mimicking/extracting structure and functions of natural products: synthetic approaches that address unexplored needs in chemical biology.

PubMed

Hirai, Go

2015-04-01

Natural products are often attractive and challenging targets for synthetic chemists, and many have interesting biological activities. However, synthetic chemists need to be more than simply suppliers of compounds to biologists. Therefore, we have been seeking ways to actively apply organic synthetic methods to chemical biology studies of natural products and their activities. In this personal review, I would like to introduce our work on the development of new biologically active compounds inspired by, or extracted from, the structures of natural products, focusing on enhancement of functional activity and specificity and overcoming various drawbacks of the parent natural products. Copyright © 2014 The Chemical Society of Japan and Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

On the influence of airfoil deviations on the aerodynamic performance of wind turbine rotors

NASA Astrophysics Data System (ADS)

Winstroth, J.; Seume, J. R.

2016-09-01

The manufacture of large wind turbine rotor blades is a difficult task that still involves a certain degree of manual labor. Due to the complexity, airfoil deviations between the design airfoils and the manufactured blade are certain to arise. Presently, the understanding of the impact of manufacturing uncertainties on the aerodynamic performance is still incomplete. The present work analyzes the influence of a series of airfoil deviations likely to occur during manufacturing by means of Computational Fluid Dynamics and the aeroelastic code FAST. The average power production of the NREL 5MW wind turbine is used to evaluate the different airfoil deviations. Analyzed deviations include: Mold tilt towards the leading and trailing edge, thick bond lines, thick bond lines with cantilever correction, backward facing steps and airfoil waviness. The most severe influences are observed for mold tilt towards the leading and thick bond lines. By applying the cantilever correction, the influence of thick bond lines is almost compensated. Airfoil waviness is very dependent on amplitude height and the location along the surface of the airfoil. Increased influence is observed for backward facing steps, once they are high enough to trigger boundary layer transition close to the leading edge.

Exploring Students' Conceptions of the Standard Deviation

ERIC Educational Resources Information Center

delMas, Robert; Liu, Yan

2005-01-01

This study investigated introductory statistics students' conceptual understanding of the standard deviation. A computer environment was designed to promote students' ability to coordinate characteristics of variation of values about the mean with the size of the standard deviation as a measure of that variation. Twelve students participated in an…

Moderate deviations-based importance sampling for stochastic recursive equations

DOE PAGES

Dupuis, Paul; Johnson, Dane

2017-11-17

Abstract Subsolutions to the Hamilton–Jacobi–Bellman equation associated with a moderate deviations approximation are used to design importance sampling changes of measure for stochastic recursive equations. Analogous to what has been done for large deviations subsolution-based importance sampling, these schemes are shown to be asymptotically optimal under the moderate deviations scaling. We present various implementations and numerical results to contrast their performance, and also discuss the circumstances under which a moderate deviation scaling might be appropriate.

Moderate deviations-based importance sampling for stochastic recursive equations

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

Dupuis, Paul; Johnson, Dane

Abstract Subsolutions to the Hamilton–Jacobi–Bellman equation associated with a moderate deviations approximation are used to design importance sampling changes of measure for stochastic recursive equations. Analogous to what has been done for large deviations subsolution-based importance sampling, these schemes are shown to be asymptotically optimal under the moderate deviations scaling. We present various implementations and numerical results to contrast their performance, and also discuss the circumstances under which a moderate deviation scaling might be appropriate.

14 CFR 142.9 - Deviations or waivers.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Deviations or waivers. 142.9 Section 142.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SCHOOLS AND... Administrator may issue deviations or waivers from any of the requirements of this part. (b) A training center...

14 CFR 142.9 - Deviations or waivers.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Deviations or waivers. 142.9 Section 142.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SCHOOLS AND... Administrator may issue deviations or waivers from any of the requirements of this part. (b) A training center...

14 CFR 142.9 - Deviations or waivers.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Deviations or waivers. 142.9 Section 142.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SCHOOLS AND... Administrator may issue deviations or waivers from any of the requirements of this part. (b) A training center...

14 CFR 142.9 - Deviations or waivers.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Deviations or waivers. 142.9 Section 142.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SCHOOLS AND... Administrator may issue deviations or waivers from any of the requirements of this part. (b) A training center...

14 CFR 142.9 - Deviations or waivers.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Deviations or waivers. 142.9 Section 142.9 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SCHOOLS AND... Administrator may issue deviations or waivers from any of the requirements of this part. (b) A training center...

Pharmaceutical, biological, and clinical properties of botulinum neurotoxin type A products.

PubMed

Frevert, Jürgen

2015-03-01

Botulinum neurotoxin injections are a valuable treatment modality for many therapeutic indications and have revolutionized the field of aesthetic medicine so that they are the leading cosmetic procedure performed worldwide. Studies show that onabotulinumtoxinA, abobotulinumtoxinA, and incobotulinumtoxinA are comparable in terms of clinical efficacy. Differences between the products relate to the botulinum neurotoxin complexes, specific biological potency, and their immunogenicity. Protein complex size and molecular weight have no effect on biological activity, stability, distribution, or side effect profile. Complexing proteins and inactive toxin (toxoid) content increase the risk of neutralizing antibody formation, which can cause secondary treatment failure, particularly in chronic disorders that require frequent injections and long-term treatment. These attributes could lead to differences in therapeutic outcomes, and, given the widespread aesthetic use of these three neurotoxin products, physicians should be aware of how they differ to ensure their safe and effective use.

A Visual Model for the Variance and Standard Deviation

ERIC Educational Resources Information Center

Orris, J. B.

2011-01-01

This paper shows how the variance and standard deviation can be represented graphically by looking at each squared deviation as a graphical object--in particular, as a square. A series of displays show how the standard deviation is the size of the average square.

Synthesis and Demonstration of the Biological Relevance of sp3 -rich Scaffolds Distantly Related to Natural Product Frameworks.

PubMed

Foley, Daniel J; Craven, Philip G E; Collins, Patrick M; Doveston, Richard G; Aimon, Anthony; Talon, Romain; Churcher, Ian; von Delft, Frank; Marsden, Stephen P; Nelson, Adam

2017-10-26

The productive exploration of chemical space is an enduring challenge in chemical biology and medicinal chemistry. Natural products are biologically relevant, and their frameworks have facilitated chemical tool and drug discovery. A "top-down" synthetic approach is described that enabled a range of complex bridged intermediates to be converted with high step efficiency into 26 diverse sp 3 -rich scaffolds. The scaffolds have local natural product-like features, but are only distantly related to specific natural product frameworks. To assess biological relevance, a set of 52 fragments was prepared, and screened by high-throughput crystallography against three targets from two protein families (ATAD2, BRD1 and JMJD2D). In each case, 3D fragment hits were identified that would serve as distinctive starting points for ligand discovery. This demonstrates that frameworks that are distantly related to natural products can facilitate discovery of new biologically relevant regions within chemical space. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

7 CFR 400.204 - Notification of deviation from standards.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 6 2010-01-01 2010-01-01 false Notification of deviation from standards. 400.204... Contract-Standards for Approval § 400.204 Notification of deviation from standards. A Contractor shall advise the Corporation immediately if the Contractor deviates from the requirements of these standards...

Potential of chicken by-products as sources of useful biological resources

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

Lasekan, Adeseye; Abu Bakar, Fatimah, E-mail: fatim@putra.upm.edu.my; Halal Products Research Institute, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor

By-products from different animal sources are currently being utilised for beneficial purposes. Chicken processing plants all over the world generate large amount of solid by-products in form of heads, legs, bones, viscera and feather. These wastes are often processed into livestock feed, fertilizers and pet foods or totally discarded. Inappropriate disposal of these wastes causes environmental pollution, diseases and loss of useful biological resources like protein, enzymes and lipids. Utilisation methods that make use of these biological components for producing value added products rather than the direct use of the actual waste material might be another viable option for dealingmore » with these wastes. This line of thought has consequently led to researches on these wastes as sources of protein hydrolysates, enzymes and polyunsaturated fatty acids. Due to the multi-applications of protein hydrolysates in various branches of science and industry, and the large body of literature reporting the conversion of animal wastes to hydrolysates, a large section of this review was devoted to this subject. Thus, this review reports the known functional and bioactive properties of hydrolysates derived from chicken by-products as well their utilisation as source of peptone in microbiological media. Methods of producing these hydrolysates including their microbiological safety are discussed. Based on the few references available in the literature, the potential of some chicken by-product as sources of proteases and polyunsaturated fatty acids are pointed out along with some other future applications.« less

Recent advances in food biopeptides: production, biological functionalities and therapeutic applications.

PubMed

Saadi, Sami; Saari, Nazamid; Anwar, Farooq; Abdul Hamid, Azizah; Ghazali, Hasanah Mohd

2015-01-01

The growing momentum of several common life-style diseases such as myocardial infarction, cardiovascular disorders, stroke, hypertension, diabetes, and atherosclerosis has become a serious global concern. Recent developments in the field of proteomics offering promising solutions to solving such health problems stimulates the uses of biopeptides as one of the therapeutic agents to alleviate disease-related risk factors. Functional peptides are typically produced from protein via enzymatic hydrolysis under in vitro or in vivo conditions using different kinds of proteolytic enzymes. An array of biological activities, including antioxidative, antihypertensive, antidiabetic and immunomodulating has been ascribed to different types of biopeptides derived from various food sources. In fact, biopeptides are nutritionally and functionally important for regulating some physiological functions in the body; however, these are yet to be extensively addressed with regard to their production through advance strategies, mechanisms of action and multiple biological functionalities. This review mainly focuses on recent biotechnological advances that are being made in the field of production in addition to covering the mode of action and biological activities, medicinal health functions and therapeutic applications of biopeptides. State-of-the-art strategies that can ameliorate the efficacy, bioavailability, and functionality of biopeptides along with their future prospects are likewise discussed. Copyright © 2015 Elsevier Inc. All rights reserved.

Biological production of ethanol from coal. Final report

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

Not Available

Due to the abundant supply of coal in the United States, significant research efforts have occurred over the past 15 years concerning the conversion of coal to liquid fuels. Researchers at the University of Arkansas have concentrated on a biological approach to coal liquefaction, starting with coal-derived synthesis gas as the raw material. Synthesis gas, a mixture of CO, H{sub 2}, CO{sub 2}, CH{sub 4} and sulfur gases, is first produced using traditional gasification techniques. The CO, CO{sub 2} and H{sub 2} are then converted to ethanol using a bacterial culture of Clostridium 1jungdahlii. Ethanol is the desired product ifmore » the resultant product stream is to be used as a liquid fuel. However, under normal operating conditions, the ``wild strain`` produces acetate in favor of ethanol in conjunction with growth in a 20:1 molar ratio. Research was performed to determine the conditions necessary to maximize not only the ratio of ethanol to acetate, but also to maximize the concentration of ethanol resulting in the product stream.« less

Online Deviation Detection for Medical Processes

PubMed Central

Christov, Stefan C.; Avrunin, George S.; Clarke, Lori A.

2014-01-01

Human errors are a major concern in many medical processes. To help address this problem, we are investigating an approach for automatically detecting when performers of a medical process deviate from the acceptable ways of performing that process as specified by a detailed process model. Such deviations could represent errors and, thus, detecting and reporting deviations as they occur could help catch errors before harm is done. In this paper, we identify important issues related to the feasibility of the proposed approach and empirically evaluate the approach for two medical procedures, chemotherapy and blood transfusion. For the evaluation, we use the process models to generate sample process executions that we then seed with synthetic errors. The process models describe the coordination of activities of different process performers in normal, as well as in exceptional situations. The evaluation results suggest that the proposed approach could be applied in clinical settings to help catch errors before harm is done. PMID:25954343

Biological activities of Agave by-products and their possible applications in food and pharmaceuticals.

PubMed

López-Romero, Julio Cesar; Ayala-Zavala, Jesús Fernando; González-Aguilar, Gustavo Adolfo; Peña-Ramos, Etna Aida; González-Ríos, Humberto

2018-05-01

Agave leaves are considered a by-product of alcoholic beverage production (tequila, mezcal and bacanora) because they are discarded during the production process, despite accounting for approximately 50% of the total plant weight. These by-products constitute a potential source of Agave extracts rich in bioactive compounds, such as saponins, phenolic compounds and terpenes, and possess different biological effects, as demonstrated by in vitro and in vivo tests (e.g. antimicrobial, antifungal, antioxidant, anti-inflammatory, antihypertensive, immunomodulatory, antiparasitic and anticancer activity). Despite their positive results in biological assays, Agave extracts have not been widely evaluated in food systems and pharmaceutical areas, and these fields represent a potential route to improve the usage of Agave plants as food additives and agents for treating medical diseases. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

21 CFR 330.11 - NDA deviations from applicable monograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false NDA deviations from applicable monograph. 330.11... EFFECTIVE AND NOT MISBRANDED Administrative Procedures § 330.11 NDA deviations from applicable monograph. A new drug application requesting approval of an OTC drug deviating in any respect from a monograph that...

21 CFR 330.11 - NDA deviations from applicable monograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false NDA deviations from applicable monograph. 330.11... EFFECTIVE AND NOT MISBRANDED Administrative Procedures § 330.11 NDA deviations from applicable monograph. A new drug application requesting approval of an OTC drug deviating in any respect from a monograph that...

21 CFR 330.11 - NDA deviations from applicable monograph.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false NDA deviations from applicable monograph. 330.11... EFFECTIVE AND NOT MISBRANDED Administrative Procedures § 330.11 NDA deviations from applicable monograph. A new drug application requesting approval of an OTC drug deviating in any respect from a monograph that...

21 CFR 330.11 - NDA deviations from applicable monograph.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false NDA deviations from applicable monograph. 330.11... EFFECTIVE AND NOT MISBRANDED Administrative Procedures § 330.11 NDA deviations from applicable monograph. A new drug application requesting approval of an OTC drug deviating in any respect from a monograph that...

21 CFR 330.11 - NDA deviations from applicable monograph.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false NDA deviations from applicable monograph. 330.11... EFFECTIVE AND NOT MISBRANDED Administrative Procedures § 330.11 NDA deviations from applicable monograph. A new drug application requesting approval of an OTC drug deviating in any respect from a monograph that...

Assessing Explosives Safety Risks, Deviations, And Consequences

DTIC Science & Technology

2009-07-31

Technical Paper 23 31 July 2009 DDESB Assessing Explosives Safety Risks, Deviations, And Consequences ...Deviations, And Consequences 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER...and approaches to assist warfighters in executing their mission, conserving resources, and maximizing operational effectiveness . When mission risk

Capturing Biological Activity in Natural Product Fragments by Chemical Synthesis

PubMed Central

Crane, Erika A.

2016-01-01

Abstract Natural products have had an immense influence on science and have directly led to the introduction of many drugs. Organic chemistry, and its unique ability to tailor natural products through synthesis, provides an extraordinary approach to unlock the full potential of natural products. In this Review, an approach based on natural product derived fragments is presented that can successfully address some of the current challenges in drug discovery. These fragments often display significantly reduced molecular weights, reduced structural complexity, a reduced number of synthetic steps, while retaining or even improving key biological parameters such as potency or selectivity. Examples from various stages of the drug development process up to the clinic are presented. In addition, this process can be leveraged by recent developments such as genome mining, antibody–drug conjugates, and computational approaches. All these concepts have the potential to identify the next generation of drug candidates inspired by natural products. PMID:26833854

40 CFR 63.1965 - What is a deviation?

Code of Federal Regulations, 2012 CFR

2012-07-01

... of the landfill monitoring and SSM plan requirements, deviations include the items in paragraphs (a.... (c) A deviation occurs when a SSM plan is not developed or maintained on site. [68 FR 2238, Jan. 16...

40 CFR 63.1965 - What is a deviation?

Code of Federal Regulations, 2014 CFR

2014-07-01

... of the landfill monitoring and SSM plan requirements, deviations include the items in paragraphs (a.... (c) A deviation occurs when a SSM plan is not developed or maintained on site. [68 FR 2238, Jan. 16...

Protocol deviations before and after IV tPA in community hospitals

PubMed Central

Adelman, Eric E.; Scott, Phillip A.; Skolarus, Lesli E.; Fox, Allison K.; Frederiksen, Shirley M.; Meurer, William J.

2015-01-01

Background Protocol deviations before and after tPA treatment for ischemic stroke are common. It is unclear if patient or hospital factors predict protocol deviations. We examined predictors of protocol deviations and the effects of protocol violations on symptomatic intracerebral hemorrhage. Methods We used data from the INSTINCT trial, a cluster-randomized, controlled trial evaluating the efficacy of a barrier assessment and educational intervention to increase appropriate tPA use in 24 Michigan community hospitals, to review tPA treatments between 2007 and 2010. Protocol violations were defined as deviations from the standard tPA protocol, both before and after treatment. Multi-level logistic regression models were fitted to determine if patient and hospital variables were associated with pre-treatment or post-treatment protocol deviations. Results During the study, 557 patients (mean age 70; 52% male; median NIHSS 12) were treated with tPA. Protocol deviations occurred in 233 (42%) patients: 16% had pre-treatment deviations, 35% had post-treatment deviations, and 9% had both. The most common protocol deviations included elevated post-treatment blood pressure, antithrombotic agent use within 24 hours of treatment, and elevated pre-treatment blood pressure. Protocol deviations were not associated with symptomatic intracerebral hemorrhage, stroke severity, or hospital factors. Older age was associated with pre-treatment protocol deviations (adjusted OR 0.52; 95% confidence interval 0.30-0.92). Pre-treatment deviations were associated with post-treatment deviations (adjusted OR 3.20; 95% confidence interval 1.91-5.35). Conclusions Protocol deviations were not associated with symptomatic intracerebral hemorrhage. Aside from age, patient and hospital factors were not associated with protocol deviations. PMID:26419527

Fatigue, pilot deviations and time of day

NASA Technical Reports Server (NTRS)

Baker, Susan P.

1989-01-01

The relationships between pilot fatigue, pilot deviations, reported incidents, and time of day are examined. A sample of 200 Aviation Safety Reporting System (ASRS) reports were analyzed from 1985 and 200 reports from 1987, plus 100 reports from late 1987 and early 1988 that were selected because of possible association with fatigue. The FAA pilot deviation data and incident data were analyzed in relation to denominator data that summarized the hourly operations (landings and takeoffs of scheduled flights) at major U.S. airports. Using as numerators FAA data on pilot deviations and incidents reported to the FAA, the rates by time of day were calculated. Pilot age was also analyzed in relation to the time of day, phase of flight, and type of incident.

Perception of midline deviations in smile esthetics by laypersons

PubMed Central

Ferreira, Jamille Barros; da Silva, Licínio Esmeraldo; Caetano, Márcia Tereza de Oliveira; da Motta, Andrea Fonseca Jardim; Cury-Saramago, Adriana de Alcantara; Mucha, José Nelson

2016-01-01

ABSTRACT Objective: To evaluate the esthetic perception of upper dental midline deviation by laypersons and if adjacent structures influence their judgment. Methods: An album with 12 randomly distributed frontal view photographs of the smile of a woman with the midline digitally deviated was evaluated by 95 laypersons. The frontal view smiling photograph was modified to create from 1 mm to 5 mm deviations in the upper midline to the left side. The photographs were cropped in two different manners and divided into two groups of six photographs each: group LCN included the lips, chin, and two-thirds of the nose, and group L included the lips only. The laypersons performed the rate of each smile using a visual analog scale (VAS). Wilcoxon test, Student’s t-test and Mann-Whitney test were applied, adopting a 5% level of significance. Results: Laypersons were able to perceive midline deviations starting at 1 mm. Statistically significant results (p< 0.05) were found for all multiple comparisons of the values in photographs of group LCN and for almost all comparisons in photographs of group L. Comparisons between the photographs of groups LCN and L showed statistically significant values (p< 0.05) when the deviation was 1 mm. Conclusions: Laypersons were able to perceive the upper dental midline deviations of 1 mm, and above when the adjacent structures of the smiles were included. Deviations of 2 mm and above when the lips only were included. The visualization of structures adjacent to the smile demonstrated influence on the perception of midline deviation. PMID:28125140

Perception of midline deviations in smile esthetics by laypersons.

PubMed

Ferreira, Jamille Barros; Silva, Licínio Esmeraldo da; Caetano, Márcia Tereza de Oliveira; Motta, Andrea Fonseca Jardim da; Cury-Saramago, Adriana de Alcantara; Mucha, José Nelson

2016-01-01

To evaluate the esthetic perception of upper dental midline deviation by laypersons and if adjacent structures influence their judgment. An album with 12 randomly distributed frontal view photographs of the smile of a woman with the midline digitally deviated was evaluated by 95 laypersons. The frontal view smiling photograph was modified to create from 1 mm to 5 mm deviations in the upper midline to the left side. The photographs were cropped in two different manners and divided into two groups of six photographs each: group LCN included the lips, chin, and two-thirds of the nose, and group L included the lips only. The laypersons performed the rate of each smile using a visual analog scale (VAS). Wilcoxon test, Student's t-test and Mann-Whitney test were applied, adopting a 5% level of significance. Laypersons were able to perceive midline deviations starting at 1 mm. Statistically significant results (p< 0.05) were found for all multiple comparisons of the values in photographs of group LCN and for almost all comparisons in photographs of group L. Comparisons between the photographs of groups LCN and L showed statistically significant values (p< 0.05) when the deviation was 1 mm. Laypersons were able to perceive the upper dental midline deviations of 1 mm, and above when the adjacent structures of the smiles were included. Deviations of 2 mm and above when the lips only were included. The visualization of structures adjacent to the smile demonstrated influence on the perception of midline deviation.

Suitability of Gray Water for Hydroponic Crop Production Following Biological and Physical Chemical and Biological Subsystems

NASA Technical Reports Server (NTRS)

Bubenheim, David L.; Harper, Lynn D.; Wignarajah, Kanapathipillai; Greene, Catherine

1994-01-01

The water present in waste streams from a human habitat must be recycled in Controlled Ecological Life Support Systems (CELSS) to limit resupply needs and attain self-sufficiency. Plants play an important role in providing food, regenerating air, and producing purified water via transpiration. However, we have shown that the surfactants present in hygiene waste water have acute toxic effects on plant growth (Bubenheim et al. 1994; Greene et al., 1994). These phytotoxic affects can be mitigated by allowing the microbial population on the root surface to degrade the surfactant, however, a significant suppression (several days) in crop performance is experienced prior to reaching sub-toxic surfactant levels and plant recovery. An effective alternative is to stabilize the microbial population responsible for degradation of the surfactant on an aerobic bioreactor and process the waste water prior to utilization in the hydroponic solution (Wisniewski and Bubenheim, 1993). A sensitive bioassay indicates that the surfactant phytotoxicity is suppressed by more than 90% within 5 hours of introduction of the gray water to the bioreactor; processing for more than 12 hours degrades more than 99% of the phytotoxin. Vapor Compression Distillation (VCD) is a physical / chemical method for water purification which employees sequential distillation steps to separate water from solids and to volatilize contaminants. The solids from the waste water are concentrated in a brine and the pure product water (70 - 90% of the total waste water volume depending on operating conditions) retains non of the phytotoxic effects. Results of the bioassay were used to guide evaluations of the suitability of recovered gray water following biological and VCD processing for hydroponic lettuce production in controlled environments. Lettuce crops were grown for 28 days with 100% of the input water supplied with recovered water from the biological processor or VCD. When compared with the growth of plants

Effect of nasal deviation on quality of life.

PubMed

de Lima Ramos, Sueli; Hochman, Bernardo; Gomes, Heitor Carvalho; Abla, Luiz Eduardo Felipe; Veiga, Daniela Francescato; Juliano, Yara; Dini, Gal Moreira; Ferreira, Lydia Masako

2011-07-01

Nasal deviation is a common complaint in otorhinolaryngology and plastic surgery. This condition not only causes impairment of nasal function but also affects quality of life, leading to psychological distress. The subjective assessment of quality of life, as an important aspect of outcomes research, has received increasing attention in recent decades. Quality of life is measured using standardized questionnaires that have been tested for reliability, validity, and sensitivity. The aim of this study was to evaluate health-related quality of life, self-esteem, and depression in patients with nasal deviation. Sixty patients were selected for the study. Patients with nasal deviation (n = 32) were assigned to the study group, and patients without nasal deviation (n = 28) were assigned to the control group. The diagnosis of nasal deviation was made by digital photogrammetry. Quality of life was assessed using the Medical Outcomes Study 36-Item Short Form Health Survey questionnaire; the Rosenberg Self-Esteem/Federal University of São Paulo, Escola Paulista de Medicina Scale; and the 20-item Self-Report Questionnaire. There were significant differences between groups in the physical functioning and general health subscales of the Medical Outcomes Study 36-Item Short Form Health Survey (p < 0.05). Depression was detected in 11 patients (34.4 percent) in the study group and in two patients in the control group, with a significant difference between groups (p < 0.05). Nasal deviation is an aspect of rhinoplasty of which the surgeon should be aware so that proper psychological diagnosis can be made and suitable treatment can be planned because psychologically the patients with nasal deviation have significantly worse quality of life and are more prone to depression. Risk, II.(Figure is included in full-text article.).

Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972. Final rule.

PubMed

2016-02-12

The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.

Auto-induction for high level production of biologically active reteplase in Escherichia coli.

PubMed

Fathi-Roudsari, Mehrnoosh; Maghsoudi, Nader; Maghsoudi, Amirhossein; Niazi, Sepideh; Soleiman, Morvarid

2018-06-07

Reteplase is a third generation tissue plasminogen activator (tPA) with a modified structure and prolonged half-life in comparison to native tPA. As a non-glycosylated protein, reteplase is expressed in Escherichia coli. Due to presence of several disulfide bonds, high level production of reteplase is complicated and needs extra steps for conversion to biologically active form. Auto-induction represents a method for high-yield growth of bacterial cells and higher expression of recombinant proteins. Here we have tried to optimize the auto-induction procedure for soluble and active expression of reteplase in E. coli. Results showed that using auto-induction strategy at 37 °C, Rosetta-gami (DE3) had the highest level of active and soluble reteplase production in comparison to E. coli strains BL21 (DE3), and Shuffel T7. Temperature dominantly affected the level of active reteplase production. Decreasing the temperature to 25 and 18 °C increased the level of active reteplase by 20 and 60%, respectively. The composition of auto-induction medium also dramatically changed the active production of reteplase in cytoplasm. Using higher enriched auto-induction medium, super broth base including trace elements, significantly increased biologically active reteplase by 30%. It is demonstrated here that auto-induction is a powerful method for expression of biologically active reteplase in oxidative cytoplasm of Rosetta-gami. Optimizing expression condition by decreasing temperature and using an enriched auto-induction medium resulted in at least three times higher level of active reteplase production. Production of correctly folded and active reteplase in spite of its complex structure helps for removal of inefficient and cumbersome step of refolding. Copyright © 2018. Published by Elsevier Inc.

Large-deviation theory for diluted Wishart random matrices

NASA Astrophysics Data System (ADS)

Castillo, Isaac Pérez; Metz, Fernando L.

2018-03-01

Wishart random matrices with a sparse or diluted structure are ubiquitous in the processing of large datasets, with applications in physics, biology, and economy. In this work, we develop a theory for the eigenvalue fluctuations of diluted Wishart random matrices based on the replica approach of disordered systems. We derive an analytical expression for the cumulant generating function of the number of eigenvalues IN(x ) smaller than x ∈R+ , from which all cumulants of IN(x ) and the rate function Ψx(k ) controlling its large-deviation probability Prob[IN(x ) =k N ] ≍e-N Ψx(k ) follow. Explicit results for the mean value and the variance of IN(x ) , its rate function, and its third cumulant are discussed and thoroughly compared to numerical diagonalization, showing very good agreement. The present work establishes the theoretical framework put forward in a recent letter [Phys. Rev. Lett. 117, 104101 (2016), 10.1103/PhysRevLett.117.104101] as an exact and compelling approach to deal with eigenvalue fluctuations of sparse random matrices.

Synthetic biology: tools to design microbes for the production of chemicals and fuels.

PubMed

Seo, Sang Woo; Yang, Jina; Min, Byung Eun; Jang, Sungho; Lim, Jae Hyung; Lim, Hyun Gyu; Kim, Seong Cheol; Kim, Se Yeon; Jeong, Jun Hong; Jung, Gyoo Yeol

2013-11-01

The engineering of biological systems to achieve specific purposes requires design tools that function in a predictable and quantitative manner. Recent advances in the field of synthetic biology, particularly in the programmable control of gene expression at multiple levels of regulation, have increased our ability to efficiently design and optimize biological systems to perform designed tasks. Furthermore, implementation of these designs in biological systems highlights the potential of using these tools to build microbial cell factories for the production of chemicals and fuels. In this paper, we review current developments in the design of tools for controlling gene expression at transcriptional, post-transcriptional and post-translational levels, and consider potential applications of these tools. Copyright © 2013 Elsevier Inc. All rights reserved.

Plankton Production Biology

DTIC Science & Technology

2007-09-30

schedule was also a discussion of a draft plan for the next decade by NASA’s Ocean Biology and Bio- geochemistry Program, tentatively entitled, “Earth’s...workshop was being held in Seattle. (GLOBEC was a ten-year field program under ICSU that was co-sponsored by the In- ternational Geosphere- Biosphere

[Clinical evaluation on the operation of the deviated nose and the deviated nasal septum with the plastic operation--report of 268 cases].

PubMed

Wang, Gang; Liu, Liu; Li, Fang

2011-04-01

To explore the feasibility of combination plastic operation on the deviation nose and the deviation nasal septum. Design the butterfly cut from the root of the columella nasi to the middle part of each alae nasi. So that the nasal septum, the cartilage septodorsalis and the nose bones could be exposed well. It was key to separate and fix the arch keystone area in the plastic operation of the deviation nose. It was key to separate septal cartilage of nose from the perpendicular plate of ethmoid bone and maxilla nose pun in plastic operation of the deviation nasal septum. Pack the vaseline oil gauze or chitosan reshaping PVA into two side of nasal cavity in order to internal fixation of nasal cavity and prevent the hematoma of nasal septum. The vaseline oil gauze can be pull out on the morning and on the afternoon 24 hours after which can reduce the pain. The external fixation of nasal cavity is not important to which can be omitted. Two hundred and sixty-eight cases after 6 to 24 months follow-up. Two hundred and twenty-eight cases were satisfied. None was unsatisfied. The combination plastic operation on the deviation nose and the deviation nasal septum, could cope with both the beauty problem and reconstruct the nose function.

Association between septal deviation and sinonasal papilloma.

PubMed

Nomura, Kazuhiro; Ogawa, Takenori; Sugawara, Mitsuru; Honkura, Yohei; Oshima, Hidetoshi; Arakawa, Kazuya; Oshima, Takeshi; Katori, Yukio

2013-12-01

Sinonasal papilloma is a common benign epithelial tumor of the sinonasal tract and accounts for 0.5% to 4% of all nasal tumors. The etiology of sinonasal papilloma remains unclear, although human papilloma virus has been proposed as a major risk factor. Other etiological factors, such as anatomical variations of the nasal cavity, may be related to the pathogenesis of sinonasal papilloma, because deviated nasal septum is seen in patients with chronic rhinosinusitis. We, therefore, investigated the involvement of deviated nasal septum in the development of sinonasal papilloma. Preoperative computed tomography or magnetic resonance imaging findings of 83 patients with sinonasal papilloma were evaluated retrospectively. The side of papilloma and the direction of septal deviation showed a significant correlation. Septum deviated to the intact side in 51 of 83 patients (61.4%) and to the affected side in 18 of 83 patients (21.7%). Straight or S-shaped septum was observed in 14 of 83 patients (16.9%). Even after excluding 27 patients who underwent revision surgery and 15 patients in whom the papilloma touched the concave portion of the nasal septum, the concave side of septal deviation was associated with the development of sinonasal papilloma (p = 0.040). The high incidence of sinonasal papilloma in the concave side may reflect the consequences of the traumatic effects caused by wall shear stress of the high-velocity airflow and the increased chance of inhaling viruses and pollutants. The present study supports the causative role of human papilloma virus and toxic chemicals in the occurrence of sinonasal papilloma.

Application of synthetic biology for production of chemicals in yeast Saccharomyces cerevisiae.

PubMed

Li, Mingji; Borodina, Irina

2015-02-01

Synthetic biology and metabolic engineering enable generation of novel cell factories that efficiently convert renewable feedstocks into biofuels, bulk, and fine chemicals, thus creating the basis for biosustainable economy independent on fossil resources. While over a hundred proof-of-concept chemicals have been made in yeast, only a very small fraction of those has reached commercial-scale production so far. The limiting factor is the high research cost associated with the development of a robust cell factory that can produce the desired chemical at high titer, rate, and yield. Synthetic biology has the potential to bring down this cost by improving our ability to predictably engineer biological systems. This review highlights synthetic biology applications for design, assembly, and optimization of non-native biochemical pathways in baker's yeast Saccharomyces cerevisiae We describe computational tools for the prediction of biochemical pathways, molecular biology methods for assembly of DNA parts into pathways, and for introducing the pathways into the host, and finally approaches for optimizing performance of the introduced pathways. © FEMS 2015. All rights reserved. For permissions, please e-mail: journals.permission@oup.com.

Perception of aircraft Deviation Cues

NASA Technical Reports Server (NTRS)

Martin, Lynne; Azuma, Ronald; Fox, Jason; Verma, Savita; Lozito, Sandra

2005-01-01

To begin to address the need for new displays, required by a future airspace concept to support new roles that will be assigned to flight crews, a study of potentially informative display cues was undertaken. Two cues were tested on a simple plan display - aircraft trajectory and flight corridor. Of particular interest was the speed and accuracy with which participants could detect an aircraft deviating outside its flight corridor. Presence of the trajectory cue significantly reduced participant reaction time to a deviation while the flight corridor cue did not. Although non-significant, the flight corridor cue seemed to have a relationship with the accuracy of participants judgments rather than their speed. As this is the second of a series of studies, these issues will be addressed further in future studies.

Temperature deviation index and elderly mortality in Japan.

PubMed

Lim, Youn-Hee; Reid, Colleen E; Honda, Yasushi; Kim, Ho

2016-07-01

Few studies have examined how the precedence of abnormal temperatures in previous neighboring years affects the population's health. In the present study, we attempted to quantify the health effects of abnormal weather patterns by creating a metric called the temperature deviation index (TDI) and estimated the effects of TDI on mortality in Japan. We used data from 47 prefectures in Japan to compute the TDI on days between May and September from 1966 to 2010. The TDI is a summed product of an indicator of absence of high temperatures in the neighboring years, and more weights were assigned to the years closest to the current year. To estimate the TDI effects on elderly mortality, we used generalized linear modeling with a Poisson distribution after adjusting for apparent temperature, barometric pressure, day of the week, and time trend. For each prefecture, we estimated the TDI effects and pooled the estimates to yield a national average for 1991-2010 in Japan. The estimated effects of TDI in middle- or high-latitude prefectures were greater than in low-latitude prefectures. The estimated national average of TDI effects was a 0.5 % (95 % confidence intervals [CI], 0.1, 1.0) increase in elderly mortality per 1-unit (around 1 standard deviation) increase in the TDI. The significant pooled estimation of TDI effects was mainly due to the TDI effects on summer days with moderate temperature (25th-49th percentile, mean temperature 22.9 °C): a 1.9 % (95 % CI, 1.1, 2.6) increase in elderly mortality per 1-unit increase in the TDI. However, TDI effects were insignificant in other temperature ranges. These findings suggest that elderly deaths increased on moderate temperature days in the summer that differed substantially from days during that time window in the neighboring years. Therefore, not only high temperature itself but also temperature deviation compared to previous years could be considered to be a risk factor for elderly mortality in the summer.

Radial gradient and radial deviation radiomic features from pre-surgical CT scans are associated with survival among lung adenocarcinoma patients.

PubMed

Tunali, Ilke; Stringfield, Olya; Guvenis, Albert; Wang, Hua; Liu, Ying; Balagurunathan, Yoganand; Lambin, Philippe; Gillies, Robert J; Schabath, Matthew B

2017-11-10

The goal of this study was to extract features from radial deviation and radial gradient maps which were derived from thoracic CT scans of patients diagnosed with lung adenocarcinoma and assess whether these features are associated with overall survival. We used two independent cohorts from different institutions for training (n= 61) and test (n= 47) and focused our analyses on features that were non-redundant and highly reproducible. To reduce the number of features and covariates into a single parsimonious model, a backward elimination approach was applied. Out of 48 features that were extracted, 31 were eliminated because they were not reproducible or were redundant. We considered 17 features for statistical analysis and identified a final model containing the two most highly informative features that were associated with lung cancer survival. One of the two features, radial deviation outside-border separation standard deviation, was replicated in a test cohort exhibiting a statistically significant association with lung cancer survival (multivariable hazard ratio = 0.40; 95% confidence interval 0.17-0.97). Additionally, we explored the biological underpinnings of these features and found radial gradient and radial deviation image features were significantly associated with semantic radiological features.

Radial gradient and radial deviation radiomic features from pre-surgical CT scans are associated with survival among lung adenocarcinoma patients

PubMed Central

Tunali, Ilke; Stringfield, Olya; Guvenis, Albert; Wang, Hua; Liu, Ying; Balagurunathan, Yoganand; Lambin, Philippe; Gillies, Robert J.; Schabath, Matthew B.

2017-01-01

The goal of this study was to extract features from radial deviation and radial gradient maps which were derived from thoracic CT scans of patients diagnosed with lung adenocarcinoma and assess whether these features are associated with overall survival. We used two independent cohorts from different institutions for training (n= 61) and test (n= 47) and focused our analyses on features that were non-redundant and highly reproducible. To reduce the number of features and covariates into a single parsimonious model, a backward elimination approach was applied. Out of 48 features that were extracted, 31 were eliminated because they were not reproducible or were redundant. We considered 17 features for statistical analysis and identified a final model containing the two most highly informative features that were associated with lung cancer survival. One of the two features, radial deviation outside-border separation standard deviation, was replicated in a test cohort exhibiting a statistically significant association with lung cancer survival (multivariable hazard ratio = 0.40; 95% confidence interval 0.17-0.97). Additionally, we explored the biological underpinnings of these features and found radial gradient and radial deviation image features were significantly associated with semantic radiological features. PMID:29221183

Drilling of a deviated well: E. C. Newell 10056-D Meigs County, Ohio

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

Rodgers, J.A.

1982-09-30

The Department of Energy's (DOE) Eastern Gas Shales Program (EGSP) has focused primarily on the resource characterization of the Devonian shales in the Appalachian, Michigan and Illinois Basins, where the collective volume of gas in place is estimated to be on the order of 280 Tcf. From an early assessment of the petrophysical properties of these shales, attention now has turned to an understanding of the mechanisms controlling production of this unconventional-gas source. However, present knowledge of the production history of the Devonian shales is inadequate for an accurate estimation of the gas reserves, the optimum well spacing for gasmore » extraction, and the preferred stimulation techniques to be used. As part of this program, a Deviated Well Test was designed to evaluate the spacing of natural fractures in the Devonian shale in Meigs County, Ohio as a follow-on test to further define shale production characteristics and to assess the benefit of additional section gained by drilling through the producing interval at the approximate angle for dip of 60/sup 0/ from vertical. The Columbia Gas Transmission Company, E.C. Newell 10056-D well, on the same site as a previous Off-Set Well Test, was selected for this investigation. This report summarizes drilling operations on this Deviated Well Test.« less

Giant Icebergs and Biological Productivity on Early Mars

NASA Astrophysics Data System (ADS)

Uceda, E.; Fairen, A. G.; Woodworth-Lynas, C.

2016-12-01

We have previously presented evidence for furrows, dump structures and chains of craters that we interpret as indication for giant iceberg transport and grounding on very cold oceans on early Mars, both in the northern plains and in the Hellas basin. Structures include: 1. Furrows: The furrows are located in elevated areas or on local topographic highs, particularly on the Hellas basin. We interpret these features in terms of iceberg rafting and grounding. 2. Chains of craters: High-resolution images of Utopia and Isidis Basins reveal chains of crater-like structures several hundred meters wide and 1 to 5 km long. 3. Dump structures: Dark boulder clusters are revealed at large scales by their slightly darker tonality with respect to the surrounding terrain. These clusters have sizes ranging from several hundred meters to 1-2 km. On Earth's oceans, giant icebergs release melting water containing nanoparticulate iron and other micronutrients, which support biological metabolism and growth to the near-coastal euphotic ecosystems, many of which are iron limited. This iron limitation of primary producers has been documented in large regions of the Earth's oceans, most notably in polar areas proximal to significant glacial activity, and is counterbalanced by the substantial enrichment of terrigenous material supplied by icebergs. The biological productivity extends hundreds of kilometres from the giant icebergs, and persists for over one month after the iceberg passes. Here we propose that giant iceberg activity on early Mars could have promoted a similar enhancing of biological productivity on the planet's oceans. The identification of specific biosignatures in icebergs trails on Earth could give clues as to what kind of biosignatures could be expected on the ancient Mars ocean floors, and where to look for them. In particular, assuming that life existed on Mars coeval to glacial activity, enhanced concentrations of organic carbon could be anticipated near giant iceberg

Visual field progression in glaucoma: total versus pattern deviation analyses.

PubMed

Artes, Paul H; Nicolela, Marcelo T; LeBlanc, Raymond P; Chauhan, Balwantray C

2005-12-01

To compare visual field progression with total and pattern deviation analyses in a prospective longitudinal study of patients with glaucoma and healthy control subjects. A group of 101 patients with glaucoma (168 eyes) with early to moderately advanced visual field loss at baseline (average mean deviation [MD], -3.9 dB) and no clinical evidence of media opacity were selected from a prospective longitudinal study on visual field progression in glaucoma. Patients were examined with static automated perimetry at 6-month intervals for a median follow-up of 9 years. At each test location, change was established with event and trend analyses of total and pattern deviation. The event analyses compared each follow-up test to a baseline obtained from averaging the first two tests, and visual field progression was defined as deterioration beyond the 5th percentile of test-retest variability at three test locations, observed on three consecutive tests. The trend analyses were based on point-wise linear regression, and visual field progression was defined as statistically significant deterioration (P < 5%) worse than -1 dB/year at three locations, confirmed by independently omitting the last and the penultimate observation. The incidence and the time-to-progression were compared between total and pattern deviation analyses. To estimate the specificity of the progression analyses, identical criteria were applied to visual fields obtained in 102 healthy control subjects, and the rate of visual field improvement was established in the patients with glaucoma and the healthy control subjects. With both event and trend methods, pattern deviation analyses classified approximately 15% fewer eyes as having progressed than did the total deviation analyses. In eyes classified as progressing by both the total and pattern deviation methods, total deviation analyses tended to detect progression earlier than the pattern deviation analyses. A comparison of the changes observed in MD and the

Yeast synthetic biology for the production of recombinant therapeutic proteins.

PubMed

Kim, Hyunah; Yoo, Su Jin; Kang, Hyun Ah

2015-02-01

The production of recombinant therapeutic proteins is one of the fast-growing areas of molecular medicine and currently plays an important role in treatment of several diseases. Yeasts are unicellular eukaryotic microbial host cells that offer unique advantages in producing biopharmaceutical proteins. Yeasts are capable of robust growth on simple media, readily accommodate genetic modifications, and incorporate typical eukaryotic post-translational modifications. Saccharomyces cerevisiae is a traditional baker's yeast that has been used as a major host for the production of biopharmaceuticals; however, several nonconventional yeast species including Hansenula polymorpha, Pichia pastoris, and Yarrowia lipolytica have gained increasing attention as alternative hosts for the industrial production of recombinant proteins. In this review, we address the established and emerging genetic tools and host strains suitable for recombinant protein production in various yeast expression systems, particularly focusing on current efforts toward synthetic biology approaches in developing yeast cell factories for the production of therapeutic recombinant proteins. © FEMS 2015. All rights reserved. For permissions, please e-mail: journals.permission@oup.com.

Biological properties

Treesearch

Rebecca E. Ibach

2005-01-01

There are numerous biological degradations that wood is exposed to in various environments. Biological damage occurs when a log, sawn product, or final product is not stored, handled, or designed properly. Biological organisms, such as bacteria, mold, stain, decay fungi, insects, and marine borers, depend heavily on temperature and moisture conditions to grow. A higher...

Determinants of ocular deviation in esotropic subjects under general anesthesia.

PubMed

Daien, Vincent; Turpin, Chloé; Lignereux, François; Belghobsi, Riadh; Le Meur, Guylene; Lebranchu, Pierre; Pechereau, Alain

2013-01-01

The authors attempted to identify the determinants of ocular deviation in a population of patients with esotropia under general anesthesia. Forty-one patients with esotropia were included. Horizontal ocular deviation was evaluated by the photographic Hirschberg test both in the awakened state and under general anesthesia before surgery. Changes in ocular deviation were measured and a multivariate analysis was used to assess its clinical determinants. The mean age (± standard deviation [SD]) of study subjects was 13 ± 11 years and 51% were females. The mean spherical equivalent refraction of the right eye was 2.44 ± 2.50 diopters (D), with no significant difference between eyes (P = .26). The mean ocular deviation changed significantly, from 33.5 ± 12.5 prism diopters (PD) at preoperative examination to 8.8 ± 11.4 PD under general anesthesia (P = .0001). The changes in ocular deviation positively correlated with the pre-operative ocular deviation (correlation coefficient r = 0.59, P = .0001) and negatively correlated with patient age (correlation coefficient r = -0.53, P = .0001). These two determinants remained significant after multivariate adjustment of the following variables: preoperative ocular deviation; age; gender; spherical equivalent refraction; and number of previous strabismus surgeries (model r(2) = 0.49, P = .0001). The ocular position under general anesthesia was reported as a key factor in the surgical treatment of subjects with esotropia; therefore, its clinical determinants were assessed. The authors observed that preoperative ocular deviation and patient age were the main factors that influenced the ocular position under general anesthesia. Copyright 2013, SLACK Incorporated.

Nasal Septal Deviations: A Systematic Review of Classification Systems.

PubMed

Teixeira, Jeffrey; Certal, Victor; Chang, Edward T; Camacho, Macario

2016-01-01

Objective. To systematically review the international literature for internal nasal septal deviation classification systems and summarize them for clinical and research purposes. Data Sources. Four databases (including PubMed/MEDLINE) were systematically searched through December 16, 2015. Methods. Systematic review, adhering to PRISMA. Results. After removal of duplicates, this study screened 952 articles for relevance. A final comprehensive review of 50 articles identified that 15 of these articles met the eligibility criteria. The classification systems defined in these articles included C-shaped, S-shaped, reverse C-shaped, and reverse S-shaped descriptions of the septal deviation in both the cephalocaudal and anteroposterior dimensions. Additional studies reported use of computed tomography and categorized deviation based on predefined locations. Three studies graded the severity of septal deviations based on the amount of deflection. The systems defined in the literature also included an evaluation of nasal septal spurs and perforations. Conclusion. This systematic review ascertained that the majority of the currently published classification systems for internal nasal septal deviations can be summarized by C-shaped or reverse C-shaped, as well as S-shaped or reverse S-shaped deviations in the anteroposterior and cephalocaudal dimensions. For imaging studies, predefined points have been defined along the septum. Common terminology can facilitate future research.

38 CFR 36.4304 - Deviations; changes of identity.

Code of Federal Regulations, 2010 CFR

2010-07-01

... identity. 36.4304 Section 36.4304 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS... Deviations; changes of identity. A deviation of more than 5 percent between the estimates upon which a... change in the identity of the property upon which the original appraisal was based, will invalidate the...

38 CFR 36.4304 - Deviations; changes of identity.

Code of Federal Regulations, 2012 CFR

2012-07-01

... identity. 36.4304 Section 36.4304 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS... Deviations; changes of identity. A deviation of more than 5 percent between the estimates upon which a... change in the identity of the property upon which the original appraisal was based, will invalidate the...

38 CFR 36.4304 - Deviations; changes of identity.

Code of Federal Regulations, 2013 CFR

2013-07-01

... identity. 36.4304 Section 36.4304 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS... Deviations; changes of identity. A deviation of more than 5 percent between the estimates upon which a... change in the identity of the property upon which the original appraisal was based, will invalidate the...

38 CFR 36.4304 - Deviations; changes of identity.

Code of Federal Regulations, 2011 CFR

2011-07-01

... identity. 36.4304 Section 36.4304 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS... Deviations; changes of identity. A deviation of more than 5 percent between the estimates upon which a... change in the identity of the property upon which the original appraisal was based, will invalidate the...

38 CFR 36.4304 - Deviations; changes of identity.

Code of Federal Regulations, 2014 CFR

2014-07-01

... identity. 36.4304 Section 36.4304 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS... Deviations; changes of identity. A deviation of more than 5 percent between the estimates upon which a... change in the identity of the property upon which the original appraisal was based, will invalidate the...

The Role of Synthetic Biology in the Design of Microbial Cell Factories for Biofuel Production

PubMed Central

Colin, Verónica Leticia; Rodríguez, Analía; Cristóbal, Héctor Antonio

2011-01-01

Insecurity in the supply of fossil fuels, volatile fuel prices, and major concerns regarding climate change have sparked renewed interest in the production of fuels from renewable resources. Because of this, the use of biodiesel has grown dramatically during the last few years and is expected to increase even further in the future. Biodiesel production through the use of microbial systems has marked a turning point in the field of biofuels since it is emerging as an attractive alternative to conventional technology. Recent progress in synthetic biology has accelerated the ability to analyze, construct, and/or redesign microbial metabolic pathways with unprecedented precision, in order to permit biofuel production that is amenable to industrial applications. The review presented here focuses specifically on the role of synthetic biology in the design of microbial cell factories for efficient production of biodiesel. PMID:22028591

Phase-I monitoring of standard deviations in multistage linear profiles

NASA Astrophysics Data System (ADS)

Kalaei, Mahdiyeh; Soleimani, Paria; Niaki, Seyed Taghi Akhavan; Atashgar, Karim

2018-03-01

In most modern manufacturing systems, products are often the output of some multistage processes. In these processes, the stages are dependent on each other, where the output quality of each stage depends also on the output quality of the previous stages. This property is called the cascade property. Although there are many studies in multistage process monitoring, there are fewer works on profile monitoring in multistage processes, especially on the variability monitoring of a multistage profile in Phase-I for which no research is found in the literature. In this paper, a new methodology is proposed to monitor the standard deviation involved in a simple linear profile designed in Phase I to monitor multistage processes with the cascade property. To this aim, an autoregressive correlation model between the stages is considered first. Then, the effect of the cascade property on the performances of three types of T 2 control charts in Phase I with shifts in standard deviation is investigated. As we show that this effect is significant, a U statistic is next used to remove the cascade effect, based on which the investigated control charts are modified. Simulation studies reveal good performances of the modified control charts.

Influence of occlusal plane inclination and mandibular deviation on esthetics

PubMed Central

Corte, Cristiane Cherobini Dalla; da Silveira, Bruno Lopes; Marquezan, Mariana

2015-01-01

Objective: The aim of this study was to assess the degree of perception of occlusal plane inclination and mandibular deviation in facial esthetics, assessed by laypeople, dentists and orthodontists. Methods: A woman with 5.88° of inclination and 5.54 mm of mandibular deviation was selected and, based on her original photograph, four new images were created correcting the deviations and creating more symmetric faces and smiles. Examiners assessed the images by means of a questionnaire. Their opinions were compared by qualitative and quantitative analyses. Results: A total of 45 laypeople, 27 dentists and 31 orthodontists filled out the questionnaires. All groups were able to perceive the asymmetry; however, orthodontists were more sensitive, identifying asymmetries as from 4.32° of occlusal plane inclination and 4.155 mm of mandibular deviation (p< 0.05). The other categories of evaluators identified asymmetries and assigned significantly lower grades, starting from 5.88° of occlusal plane inclination and 5.54 mm of mandibular deviation (p< 0.05). Conclusion: Occlusal plane inclination and mandibular deviation were perceived by all groups, but orthodontists presented higher perception of deviations. PMID:26560821

Connecting marine productivity to sea-spray via microscale biological processes: phytoplancton demise and viral infection

NASA Astrophysics Data System (ADS)

Facchini, C.; O'Dowd, C. D. D.; Danovaro, R.

2015-12-01

The processes that link phytoplankton biomass and productivity to the organic matter enrichment in sea spray aerosol are far from being elucidated and modelling predictions remain highly uncertain at the moment. While some studies have asserted that the enrichment of OM in sea spray aerosol is independent on marine productivity, others, have shown significant correlation with phytoplankton biomass and productivity (Chl-a retrieved by satellites). We present here new results illustrating a clear link between OM mass-fraction enrichment in sea spray (OMss) and both phytoplankton-biomass and Net Primary Productivity (NPP). We suggest that the OM enrichment of sea spray through the demise of the bloom, driven by nanoscale biological processes (such as viral infections), which determine the release of celldebris, exudates and other colloidal material. This OM, through processes, leads to enrichment in sea-spray, thus demonstrating an important coupling between biologically-drive plankton bloom termination, marine productivity and sea-spraymodification with potentially significant climate impacts.

Improvements in algal lipid production: a systems biology and gene editing approach.

PubMed

Banerjee, Avik; Banerjee, Chiranjib; Negi, Sangeeta; Chang, Jo-Shu; Shukla, Pratyoosh

2018-05-01

In the wake of rising energy demands, microalgae have emerged as potential sources of sustainable and renewable carbon-neutral fuels, such as bio-hydrogen and bio-oil. For rational metabolic engineering, the elucidation of metabolic pathways in fine detail and their manipulation according to requirements is the key to exploiting the use of microalgae. Emergence of site-specific nucleases have revolutionized applied research leading to biotechnological gains. Genome engineering as well as modulation of the endogenous genome with high precision using CRISPR systems is being gradually employed in microalgal research. Further, to optimize and produce better algal platforms, use of systems biology network analysis and integration of omics data is required. This review discusses two important approaches: systems biology and gene editing strategies used on microalgal systems with a focus on biofuel production and sustainable solutions. It also emphasizes that the integration of such systems would contribute and compliment applied research on microalgae. Recent advances in microalgae are discussed, including systems biology, gene editing approaches in lipid bio-synthesis, and antenna engineering. Lastly, it has been attempted here to showcase how CRISPR/Cas systems are a better editing tool than existing techniques that can be utilized for gene modulation and engineering during biofuel production.

7 CFR 400.174 - Notification of deviation from financial standards.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 6 2010-01-01 2010-01-01 false Notification of deviation from financial standards... Agreement-Standards for Approval; Regulations for the 1997 and Subsequent Reinsurance Years § 400.174 Notification of deviation from financial standards. An insurer must immediately advise FCIC if it deviates from...

77 FR 30887 - Amendments to Sterility Test Requirements for Biological Products; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-24

... Biological Products; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule, correction... Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 600, 610, and...

Density Large Deviations for Multidimensional Stochastic Hyperbolic Conservation Laws

NASA Astrophysics Data System (ADS)

Barré, J.; Bernardin, C.; Chetrite, R.

2018-02-01

We investigate the density large deviation function for a multidimensional conservation law in the vanishing viscosity limit, when the probability concentrates on weak solutions of a hyperbolic conservation law. When the mobility and diffusivity matrices are proportional, i.e. an Einstein-like relation is satisfied, the problem has been solved in Bellettini and Mariani (Bull Greek Math Soc 57:31-45, 2010). When this proportionality does not hold, we compute explicitly the large deviation function for a step-like density profile, and we show that the associated optimal current has a non trivial structure. We also derive a lower bound for the large deviation function, valid for a more general weak solution, and leave the general large deviation function upper bound as a conjecture.

Alien Biochemistries and Their Metabolic By-Products. Lessons from Synthetic Biology

NASA Astrophysics Data System (ADS)

Benner, S.

2014-03-01

While the metabolisms of terran organisms are accessible for study and their byproducts are, for the most part, well known, the "diversity" of terran biology arises (as far as we know) from a single common ancestor, represents only a small fraction of possible chemical difersity, and may reflect only a fraction of the possible chemical diversity that might support Darwinian evolution [1]. This talk will consider laboratory experiments on origins [2] and synthetic biology [3], asking how they might inform us about alternative biochemistries, and whether we have any chance of observing remotely their by-products, recognizing the uncertanties in both our models for "weird life" and our models of abiotic processes in incompletely defined planetary environments.

Adaptive neural coding: from biological to behavioral decision-making

PubMed Central

Louie, Kenway; Glimcher, Paul W.; Webb, Ryan

2015-01-01

Empirical decision-making in diverse species deviates from the predictions of normative choice theory, but why such suboptimal behavior occurs is unknown. Here, we propose that deviations from optimality arise from biological decision mechanisms that have evolved to maximize choice performance within intrinsic biophysical constraints. Sensory processing utilizes specific computations such as divisive normalization to maximize information coding in constrained neural circuits, and recent evidence suggests that analogous computations operate in decision-related brain areas. These adaptive computations implement a relative value code that may explain the characteristic context-dependent nature of behavioral violations of classical normative theory. Examining decision-making at the computational level thus provides a crucial link between the architecture of biological decision circuits and the form of empirical choice behavior. PMID:26722666

Endometrioid adenocarcinoma of the uterus with a minimal deviation invasive pattern.

PubMed

Landry, D; Mai, K T; Senterman, M K; Perkins, D G; Yazdi, H M; Veinot, J P; Thomas, J

2003-01-01

Minimal deviation adenocarcinoma of endometrioid type is a rare pathological entity. We describe a variant of typical endometrioid adenocarcinoma associated with minimal deviation adenocarcinoma of endometrioid type. One 'pilot' case of minimal deviation adenocarcinoma of endometrioid type associated with typical endometrioid adenocarcinoma was encountered at our institution in 2001. A second case of same type was received in consultation. We reviewed 168 consecutive hysterectomy specimens diagnosed with 'endometrioid adenocarcinoma' specifically to identify areas of minimal deviation adenocarcinoma of endometrioid type. Immunohistochemistry was done with the following antibodies: MIB1, p53, oestrogen receptor (ER), progesterone receptor (PR), cytokeratin 7 (CK7), cytokeratin 20 (CK20), carcinoembryonic antigen (CEA), and vimentin (VIM). Four additional cases of minimal deviation adenocarcinoma of endometrioid type were identified. All six cases of minimal deviation adenocarcinoma of endometrioid type were associated with superficial endometrioid adenocarcinoma. In two cases with a large amount of minimal deviation adenocarcinoma of endometrioid type, the cervix was involved. The immunoprofile of two representative cases was ER+, PR+, CK7+, CK20-, CEA-, VIM+. MIB1 immunostaining of four cases revealed little proliferative activity of the minimal deviation adenocarcinoma of endometrioid type glandular cells (0-1%) compared with the associated 'typical' endometrioid adenocarcinoma (20-30%). The same four cases showed no p53 immunostaining in minimal deviation adenocarcinoma of endometrioid type compared with a range of positive staining in the associated endometrioid adenocarcinoma. Minimal deviation adenocarcinoma of endometrioid type more often develops as a result of differentiation from typical endometrioid adenocarcinoma than de novo. Due to its deceptively benign microscopic appearance, minimal deviation adenocarcinoma of endometrioid type may be overlooked and

[Recent advances of synthetic biology for production of functional ingredients in Chinese materia medica].

PubMed

Su, Xin-Yao; Xue, Jian-Ping; Wang, Cai-Xia

2016-11-01

The functional ingredients in Chinese materia medica are the main active substance for traditional Chinese medicine and most of them are secondary metabolites derivatives. Until now,the main method to obtain those functional ingredients is through direct extraction from the Chinese materia medica. However, the income is very low because of the high extraction costs and the decreased medicinal plants. Synthetic biology technology, as a new and microbial approach, can be able to carry out large-scale production of functional ingredients and greatly ease the shortage of traditional Chinese medicine ingredients. This review mainly focused on the recent advances in synthetic biology for the functional ingredients production. Copyright© by the Chinese Pharmaceutical Association.

20 CFR 435.4 - Deviations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Deviations. 435.4 Section 435.4 Employees' Benefits SOCIAL SECURITY ADMINISTRATION UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, OTHER NON-PROFIT ORGANIZATIONS, AND COMMERCIAL ORGANIZATIONS...

7 CFR 3430.3 - Deviations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 15 2011-01-01 2011-01-01 false Deviations. 3430.3 Section 3430.3 Agriculture Regulations of the Department of Agriculture (Continued) NATIONAL INSTITUTE OF FOOD AND AGRICULTURE COMPETITIVE AND NONCOMPETITIVE NON-FORMULA FEDERAL ASSISTANCE PROGRAMS-GENERAL AWARD ADMINISTRATIVE PROVISIONS...

Conference Report: ESF-COST High-Level Research Conference Natural Products Chemistry, Biology and Medicine III.

PubMed

Catino, Arthur

2010-12-01

Natural Products Chemistry, Biology and Medicine III was the third conference in a series of events sponsored by the European Science Foundation (ESF) and the European Cooperation in the field of Scientific and Technical Research (COST). Scientists came together from within and outside the EU to present cutting-edge developments in chemical synthesis. Research areas included the synthesis of natural products, methods development, isolation/structural elucidation and chemical biology. As our capacity to produce new chemotherapeutic agents relies on chemical synthesis, this year's conference has never been so timely. This report highlights several of the scientific contributions presented during the meeting.

Characterization of persistent colors and decolorization of effluent from biologically treated cellulosic ethanol production wastewater.

PubMed

Shan, Lili; Liu, Junfeng; Yu, Yanling; Ambuchi, John J; Feng, Yujie

2016-05-01

The high chroma of cellulosic ethanol production wastewater poses a serious environmental concern; however, color-causing compounds are still not fully clear. The characteristics of the color compounds and decolorization of biologically treated effluent by electro-catalytic oxidation were investigated in this study. Excitation-emission matrix (EEM), fourier transform infrared spectrometer (FTIR), UV-Vis spectra, and ultrafiltration (UF) fractionation were used to analyze color compounds. High chroma of wastewater largely comes from humic materials, which exhibited great fluorescence proportion (67.1 %) in the biologically treated effluent. Additionally, the color compounds were mainly distributed in the molecular weight fractions with 3-10 and 10-30 kDa, which contributed 53.5 and 34.6 % of the wastewater color, respectively. Further decolorization of biologically treated effluent by electro-catalytic oxidation was investigated, and 98.3 % of color removal accompanied with 97.3 % reduction of humic acid-like matter was achieved after 180 min. The results presented herein will facilitate the development of a well decolorization for cellulosic ethanol production wastewater and better understanding of the biological fermentation.

Genome Engineering and Modification Toward Synthetic Biology for the Production of Antibiotics.

PubMed

Zou, Xuan; Wang, Lianrong; Li, Zhiqiang; Luo, Jie; Wang, Yunfu; Deng, Zixin; Du, Shiming; Chen, Shi

2018-01-01

Antibiotic production is often governed by large gene clusters composed of genes related to antibiotic scaffold synthesis, tailoring, regulation, and resistance. With the expansion of genome sequencing, a considerable number of antibiotic gene clusters has been isolated and characterized. The emerging genome engineering techniques make it possible towards more efficient engineering of antibiotics. In addition to genomic editing, multiple synthetic biology approaches have been developed for the exploration and improvement of antibiotic natural products. Here, we review the progress in the development of these genome editing techniques used to engineer new antibiotics, focusing on three aspects of genome engineering: direct cloning of large genomic fragments, genome engineering of gene clusters, and regulation of gene cluster expression. This review will not only summarize the current uses of genomic engineering techniques for cloning and assembly of antibiotic gene clusters or for altering antibiotic synthetic pathways but will also provide perspectives on the future directions of rebuilding biological systems for the design of novel antibiotics. © 2017 Wiley Periodicals, Inc.

Synthesis and Demonstration of the Biological Relevance of sp3‐rich Scaffolds Distantly Related to Natural Product Frameworks

PubMed Central

Foley, Daniel J.; Craven, Philip G. E.; Collins, Patrick M.; Doveston, Richard G.; Aimon, Anthony; Talon, Romain; Churcher, Ian; von Delft, Frank

2017-01-01

Abstract The productive exploration of chemical space is an enduring challenge in chemical biology and medicinal chemistry. Natural products are biologically relevant, and their frameworks have facilitated chemical tool and drug discovery. A “top‐down” synthetic approach is described that enabled a range of complex bridged intermediates to be converted with high step efficiency into 26 diverse sp3‐rich scaffolds. The scaffolds have local natural product‐like features, but are only distantly related to specific natural product frameworks. To assess biological relevance, a set of 52 fragments was prepared, and screened by high‐throughput crystallography against three targets from two protein families (ATAD2, BRD1 and JMJD2D). In each case, 3D fragment hits were identified that would serve as distinctive starting points for ligand discovery. This demonstrates that frameworks that are distantly related to natural products can facilitate discovery of new biologically relevant regions within chemical space. PMID:28983993

A General Conditional Large Deviation Principle

DOE PAGES

La Cour, Brian R.; Schieve, William C.

2015-07-18

Given a sequence of Borel probability measures on a Hausdorff space which satisfy a large deviation principle (LDP), we consider the corresponding sequence of measures formed by conditioning on a set B. If the large deviation rate function I is good and effectively continuous, and the conditioning set has the property that (1)more » $$\\overline{B°}$$=$$\\overline{B}$$ and (2) I(x)<∞ for all xε$$\\overline{B}$$, then the sequence of conditional measures satisfies a LDP with the good, effectively continuous rate function I B, where I B(x)=I(x)-inf I(B) if xε$$\\overline{B}$$ and I B(x)=∞ otherwise.« less

Integrated catalytic wet air oxidation and biological treatment of wastewater from Vitamin B 6 production

NASA Astrophysics Data System (ADS)

Kang, Jianxiong; Zhan, Wei; Li, Daosheng; Wang, Xiaocong; Song, Jing; Liu, Dongqi

This study investigated the feasibility of coupling a catalytic wet air oxidation (CWAO), with CuO/Al 2O 3 as catalyst, and an anaerobic/aerobic biological process to treat wastewater from Vitamin B 6 production. Results showed that the CWAO enhanced the biodegradability (BOD 5/COD) from 0.10 to 0.80. The oxidized effluents with COD of 10,000 mg l -1 was subjected to subsequent continuous anaerobic/aerobic oxidation, and 99.3% of total COD removal was achieved. The quality of the effluent obtained met the discharge standards of water pollutants for pharmaceutical industry Chemical Synthesis Products Category (GB21904-2008), and thereby it implies that the integrated CWAO and anaerobic/aerobic biological treatment may offer a promising process to treat wastewater from Vitamin B 6 production.

Biological risks associated with consumption of reptile products.

PubMed

Magnino, Simone; Colin, Pierre; Dei-Cas, Eduardo; Madsen, Mogens; McLauchlin, Jim; Nöckler, Karsten; Maradona, Miguel Prieto; Tsigarida, Eirini; Vanopdenbosch, Emmanuel; Van Peteghem, Carlos

2009-09-15

The consumption of a wide variety of species of reptiles caught from the wild has been an important source of protein for humans world-wide for millennia. Terrapins, snakes, lizards, crocodiles and iguanas are now farmed and the consumption and trade of their meat and other edible products have recently increased in some areas of the world. Biological risks associated with the consumption of products from both farmed and wild reptile meat and eggs include infections caused by bacteria (Salmonella spp., Vibrio spp.), parasites (Spirometra, Trichinella, Gnathostoma, pentastomids), as well as intoxications by biotoxins. For crocodiles, Salmonella spp. constitute a significant public health risk due to the high intestinal carrier rate which is reflected in an equally high contamination rate in their fresh and frozen meat. There is a lack of information about the presence of Salmonella spp. in meat from other edible reptilians, though captive reptiles used as pets (lizards or turtles) are frequently carriers of these bacteria in Europe. Parasitic protozoa in reptiles represent a negligible risk for public health compared to parasitic metazoans, of which trichinellosis, pentastomiasis, gnathostomiasis and sparganosis can be acquired through consumption of contaminated crocodile, monitor lizard, turtle and snake meat, respectively. Other reptiles, although found to harbour the above parasites, have not been implicated with their transmission to humans. Freezing treatment inactivates Spirometra and Trichinella in crocodile meat, while the effectiveness of freezing of other reptilian meat is unknown. Biotoxins that accumulate in the flesh of sea turtles may cause chelonitoxism, a type of food poisoning with a high mortality rate in humans. Infections by fungi, including yeasts, and viruses widely occur in reptiles but have not been linked to a human health risk through the contamination of their meat. Currently there are no indications that natural transmissible spongiform

2 CFR 170.115 - Deviations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 2 Grants and Agreements 1 2012-01-01 2012-01-01 false Deviations. 170.115 Section 170.115 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF MANAGEMENT AND BUDGET GOVERNMENTWIDE GUIDANCE FOR GRANTS AND AGREEMENTS NATIONAL POLICY REQUIREMENTS REPORTING...

2 CFR 170.115 - Deviations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 2 Grants and Agreements 1 2014-01-01 2014-01-01 false Deviations. 170.115 Section 170.115 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF MANAGEMENT AND BUDGET GOVERNMENTWIDE GUIDANCE FOR GRANTS AND AGREEMENTS Reserved REPORTING SUBAWARD AND EXECUTIVE...

2 CFR 170.115 - Deviations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 2 Grants and Agreements 1 2013-01-01 2013-01-01 false Deviations. 170.115 Section 170.115 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF MANAGEMENT AND BUDGET GOVERNMENTWIDE GUIDANCE FOR GRANTS AND AGREEMENTS NATIONAL POLICY REQUIREMENTS REPORTING...

2 CFR 170.115 - Deviations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 2 Grants and Agreements 1 2011-01-01 2011-01-01 false Deviations. 170.115 Section 170.115 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF MANAGEMENT AND BUDGET GOVERNMENTWIDE GUIDANCE FOR GRANTS AND AGREEMENTS [Reserved] REPORTING SUBAWARD AND...

48 CFR 2901.405 - Deviations pertaining to treaties and executive agreements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... DOLAR 2901.405 Deviations pertaining to treaties and executive agreements. (a) The Director, DAMS is... deviations not authorized by FAR 1.405(b) or (c), the Director, DAMS, will process the request for deviation...

48 CFR 2901.405 - Deviations pertaining to treaties and executive agreements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... DOLAR 2901.405 Deviations pertaining to treaties and executive agreements. (a) The Director, DAMS is... deviations not authorized by FAR 1.405(b) or (c), the Director, DAMS, will process the request for deviation...

Creating biological nanomaterials using synthetic biology.

PubMed

Rice, MaryJoe K; Ruder, Warren C

2014-02-01

Synthetic biology is a new discipline that combines science and engineering approaches to precisely control biological networks. These signaling networks are especially important in fields such as biomedicine and biochemical engineering. Additionally, biological networks can also be critical to the production of naturally occurring biological nanomaterials, and as a result, synthetic biology holds tremendous potential in creating new materials. This review introduces the field of synthetic biology, discusses how biological systems naturally produce materials, and then presents examples and strategies for incorporating synthetic biology approaches in the development of new materials. In particular, strategies for using synthetic biology to produce both organic and inorganic nanomaterials are discussed. Ultimately, synthetic biology holds the potential to dramatically impact biological materials science with significant potential applications in medical systems.

Complexity analysis based on generalized deviation for financial markets

NASA Astrophysics Data System (ADS)

Li, Chao; Shang, Pengjian

2018-03-01

In this paper, a new modified method is proposed as a measure to investigate the correlation between past price and future volatility for financial time series, known as the complexity analysis based on generalized deviation. In comparison with the former retarded volatility model, the new approach is both simple and computationally efficient. The method based on the generalized deviation function presents us an exhaustive way showing the quantization of the financial market rules. Robustness of this method is verified by numerical experiments with both artificial and financial time series. Results show that the generalized deviation complexity analysis method not only identifies the volatility of financial time series, but provides a comprehensive way distinguishing the different characteristics between stock indices and individual stocks. Exponential functions can be used to successfully fit the volatility curves and quantify the changes of complexity for stock market data. Then we study the influence for negative domain of deviation coefficient and differences during the volatile periods and calm periods. after the data analysis of the experimental model, we found that the generalized deviation model has definite advantages in exploring the relationship between the historical returns and future volatility.

Size-dependent standard deviation for growth rates: Empirical results and theoretical modeling

NASA Astrophysics Data System (ADS)

Podobnik, Boris; Horvatic, Davor; Pammolli, Fabio; Wang, Fengzhong; Stanley, H. Eugene; Grosse, I.

2008-05-01

We study annual logarithmic growth rates R of various economic variables such as exports, imports, and foreign debt. For each of these variables we find that the distributions of R can be approximated by double exponential (Laplace) distributions in the central parts and power-law distributions in the tails. For each of these variables we further find a power-law dependence of the standard deviation σ(R) on the average size of the economic variable with a scaling exponent surprisingly close to that found for the gross domestic product (GDP) [Phys. Rev. Lett. 81, 3275 (1998)]. By analyzing annual logarithmic growth rates R of wages of 161 different occupations, we find a power-law dependence of the standard deviation σ(R) on the average value of the wages with a scaling exponent β≈0.14 close to those found for the growth of exports, imports, debt, and the growth of the GDP. In contrast to these findings, we observe for payroll data collected from 50 states of the USA that the standard deviation σ(R) of the annual logarithmic growth rate R increases monotonically with the average value of payroll. However, also in this case we observe a power-law dependence of σ(R) on the average payroll with a scaling exponent β≈-0.08 . Based on these observations we propose a stochastic process for multiple cross-correlated variables where for each variable (i) the distribution of logarithmic growth rates decays exponentially in the central part, (ii) the distribution of the logarithmic growth rate decays algebraically in the far tails, and (iii) the standard deviation of the logarithmic growth rate depends algebraically on the average size of the stochastic variable.

Size-dependent standard deviation for growth rates: empirical results and theoretical modeling.

PubMed

Podobnik, Boris; Horvatic, Davor; Pammolli, Fabio; Wang, Fengzhong; Stanley, H Eugene; Grosse, I

2008-05-01

We study annual logarithmic growth rates R of various economic variables such as exports, imports, and foreign debt. For each of these variables we find that the distributions of R can be approximated by double exponential (Laplace) distributions in the central parts and power-law distributions in the tails. For each of these variables we further find a power-law dependence of the standard deviation sigma(R) on the average size of the economic variable with a scaling exponent surprisingly close to that found for the gross domestic product (GDP) [Phys. Rev. Lett. 81, 3275 (1998)]. By analyzing annual logarithmic growth rates R of wages of 161 different occupations, we find a power-law dependence of the standard deviation sigma(R) on the average value of the wages with a scaling exponent beta approximately 0.14 close to those found for the growth of exports, imports, debt, and the growth of the GDP. In contrast to these findings, we observe for payroll data collected from 50 states of the USA that the standard deviation sigma(R) of the annual logarithmic growth rate R increases monotonically with the average value of payroll. However, also in this case we observe a power-law dependence of sigma(R) on the average payroll with a scaling exponent beta approximately -0.08 . Based on these observations we propose a stochastic process for multiple cross-correlated variables where for each variable (i) the distribution of logarithmic growth rates decays exponentially in the central part, (ii) the distribution of the logarithmic growth rate decays algebraically in the far tails, and (iii) the standard deviation of the logarithmic growth rate depends algebraically on the average size of the stochastic variable.

WebBio, a web-based management and analysis system for patient data of biological products in hospital.

PubMed

Lu, Ying-Hao; Kuo, Chen-Chun; Huang, Yaw-Bin

2011-08-01

We selected HTML, PHP and JavaScript as the programming languages to build "WebBio", a web-based system for patient data of biological products and used MySQL as database. WebBio is based on the PHP-MySQL suite and is run by Apache server on Linux machine. WebBio provides the functions of data management, searching function and data analysis for 20 kinds of biological products (plasma expanders, human immunoglobulin and hematological products). There are two particular features in WebBio: (1) pharmacists can rapidly find out whose patients used contaminated products for medication safety, and (2) the statistics charts for a specific product can be automatically generated to reduce pharmacist's work loading. WebBio has successfully turned traditional paper work into web-based data management.

2 CFR 25.115 - Deviations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 2 Grants and Agreements 1 2014-01-01 2014-01-01 false Deviations. 25.115 Section 25.115 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF MANAGEMENT AND BUDGET GOVERNMENTWIDE GUIDANCE FOR GRANTS AND AGREEMENTS Reserved UNIVERSAL IDENTIFIER AND CENTRAL CONTRACTOR...

2 CFR 25.115 - Deviations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 2 Grants and Agreements 1 2013-01-01 2013-01-01 false Deviations. 25.115 Section 25.115 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF MANAGEMENT AND BUDGET GOVERNMENTWIDE GUIDANCE FOR GRANTS AND AGREEMENTS PRE-AWARD RESPONSIBILITIES UNIVERSAL IDENTIFIER AND CENTRAL...

2 CFR 25.115 - Deviations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 2 Grants and Agreements 1 2012-01-01 2012-01-01 false Deviations. 25.115 Section 25.115 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF MANAGEMENT AND BUDGET GOVERNMENTWIDE GUIDANCE FOR GRANTS AND AGREEMENTS PRE-AWARD RESPONSIBILITIES UNIVERSAL IDENTIFIER AND CENTRAL...

2 CFR 25.115 - Deviations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 2 Grants and Agreements 1 2011-01-01 2011-01-01 false Deviations. 25.115 Section 25.115 Grants and Agreements Office of Management and Budget Guidance for Grants and Agreements OFFICE OF MANAGEMENT AND BUDGET GOVERNMENTWIDE GUIDANCE FOR GRANTS AND AGREEMENTS Pre-award responsibilities UNIVERSAL IDENTIFIER AND CENTRAL...

37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

Code of Federal Regulations, 2013 CFR

2013-07-01

... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug, antibiotic...

37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

Code of Federal Regulations, 2012 CFR

2012-07-01

... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug, antibiotic...

37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

Code of Federal Regulations, 2014 CFR

2014-07-01

... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug, antibiotic...

37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

Code of Federal Regulations, 2011 CFR

2011-07-01

... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug, antibiotic...

37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

Code of Federal Regulations, 2010 CFR

2010-07-01

... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug, antibiotic...

Refraction in Terms of the Deviation of the Light.

ERIC Educational Resources Information Center

Goldberg, Fred M.

1985-01-01

Discusses refraction in terms of the deviation of light. Points out that in physics courses where very little mathematics is used, it might be more suitable to describe refraction entirely in terms of the deviation, rather than by introducing Snell's law. (DH)

Developmental Dyslexia, Neurolinguistic Theory and Deviations in Brain Morphology.

ERIC Educational Resources Information Center

Hynd, George W.; And Others

1991-01-01

Reviews computer tomography and magnetic resonance imaging studies examining deviations in brain morphology. Discusses methodological and technical issues. Concludes that dyslexics show variations in specific brain regions. Suggests that neuroimaging procedures appear to provide direct evidence supporting the importance of deviations in normal…

Spectrophotometric determination of 4-acetamidophenyl N'-(sulphanilamide) acetate in biological fluids.

PubMed

Shah, Bhavna; Patil, Pravin; Shah, Hirva

2014-01-01

A simple, accurate and low cost spectrophotometric method is proposed for the determination of the synthesized paracetamol derivative; 4-acetamidophenyl N'-(sulphanilamide) acetate (APSA) in biological fluids. The spectrophotometric method is based on a condensation reaction between the alcoholic solution of APSA and acidic solution of p-dimethylaminobenzaldeyde (DPMK) to generate a yellow colored product. The linear range for the determination of APSA was 1-10 µg mL(-1) with molar absorptivity of 3.6877 × 10(4) L mol(-1) cm(-1) and Sandell's sensitivity of 0.001 µg cm-2/0.001 absorbance unit. During the inter-day and intra-day analysis, the relative standard deviation for replicated determination of APSA was found to be less than 2.0% and accuracy was 99.20-101.60% and 99.10-101.30% in blood and urine samples, respectively. There was no interference with commonly used blood and urine sample. The developed spectrophotometric method was successfully applied to assess APSA in biological fluids.

Current advance in biological production of malic acid using wild type and metabolic engineered strains.

PubMed

Dai, Zhongxue; Zhou, Huiyuan; Zhang, Shangjie; Gu, Honglian; Yang, Qiao; Zhang, Wenming; Dong, Weiliang; Ma, Jiangfeng; Fang, Yan; Jiang, Min; Xin, Fengxue

2018-06-01

Malic acid (2-hydroxybutanedioic acid) is a four-carbon dicarboxylic acid, which has attracted great interest due to its wide usage as a precursor of many industrially important chemicals in the food, chemicals, and pharmaceutical industries. Several mature routes for malic acid production have been developed, such as chemical synthesis, enzymatic conversion and biological fermentation. With depletion of fossil fuels and concerns regarding environmental issues, biological production of malic acid has attracted more attention, which mainly consists of three pathways, namely non-oxidative pathway, oxidative pathway and glyoxylate cycle. In recent decades, metabolic engineering of model strains, and process optimization for malic acid production have been rapidly developed. Hence, this review comprehensively introduces an overview of malic acid producers and highlight some of the successful metabolic engineering approaches. Copyright © 2018 Elsevier Ltd. All rights reserved.

Mean-deviation analysis in the theory of choice.

PubMed

Grechuk, Bogdan; Molyboha, Anton; Zabarankin, Michael

2012-08-01

Mean-deviation analysis, along with the existing theories of coherent risk measures and dual utility, is examined in the context of the theory of choice under uncertainty, which studies rational preference relations for random outcomes based on different sets of axioms such as transitivity, monotonicity, continuity, etc. An axiomatic foundation of the theory of coherent risk measures is obtained as a relaxation of the axioms of the dual utility theory, and a further relaxation of the axioms are shown to lead to the mean-deviation analysis. Paradoxes arising from the sets of axioms corresponding to these theories and their possible resolutions are discussed, and application of the mean-deviation analysis to optimal risk sharing and portfolio selection in the context of rational choice is considered. © 2012 Society for Risk Analysis.

Linking neuroethology to the chemical biology of natural products: interactions between cone snails and their fish prey, a case study.

PubMed

Olivera, Baldomero M; Raghuraman, Shrinivasan; Schmidt, Eric W; Safavi-Hemami, Helena

2017-09-01

From a biological perspective, a natural product can be defined as a compound evolved by an organism for chemical interactions with another organism including prey, predator, competitor, pathogen, symbiont or host. Natural products hold tremendous potential as drug leads and have been extensively studied by chemists and biochemists in the pharmaceutical industry. However, the biological purpose for which a natural product evolved is rarely addressed. By focusing on a well-studied group of natural products-venom components from predatory marine cone snails-this review provides a rationale for why a better understanding of the evolution, biology and biochemistry of natural products will facilitate both neuroscience and the potential for drug leads. The larger goal is to establish a new sub-discipline in the broader field of neuroethology that we refer to as "Chemical Neuroethology", linking the substantial work carried out by chemists on natural products with accelerating advances in neuroethology.

78 FR 65904 - Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-04

... in the manufacture of the drug or an interruption in the manufacturing of the drug that is likely to... Manufacturing of Certain Drug or Biological Products AGENCY: Food and Drug Administration, HHS. ACTION: Proposed... permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a...

Deviations from Newton's law in supersymmetric large extra dimensions

NASA Astrophysics Data System (ADS)

Callin, P.; Burgess, C. P.

2006-09-01

Deviations from Newton's inverse-squared law at the micron length scale are smoking-gun signals for models containing supersymmetric large extra dimensions (SLEDs), which have been proposed as approaches for resolving the cosmological constant problem. Just like their non-supersymmetric counterparts, SLED models predict gravity to deviate from the inverse-square law because of the advent of new dimensions at sub-millimeter scales. However SLED models differ from their non-supersymmetric counterparts in three important ways: (i) the size of the extra dimensions is fixed by the observed value of the dark energy density, making it impossible to shorten the range over which new deviations from Newton's law must be seen; (ii) supersymmetry predicts there to be more fields in the extra dimensions than just gravity, implying different types of couplings to matter and the possibility of repulsive as well as attractive interactions; and (iii) the same mechanism which is purported to keep the cosmological constant naturally small also keeps the extra-dimensional moduli effectively massless, leading to deviations from general relativity in the far infrared of the scalar-tensor form. We here explore the deviations from Newton's law which are predicted over micron distances, and show the ways in which they differ and resemble those in the non-supersymmetric case.

Microbial production of natural and non-natural flavonoids: Pathway engineering, directed evolution and systems/synthetic biology.

PubMed

Pandey, Ramesh Prasad; Parajuli, Prakash; Koffas, Mattheos A G; Sohng, Jae Kyung

2016-01-01

In this review, we address recent advances made in pathway engineering, directed evolution, and systems/synthetic biology approaches employed in the production and modification of flavonoids from microbial cells. The review is divided into two major parts. In the first, various metabolic engineering and system/synthetic biology approaches used for production of flavonoids and derivatives are discussed broadly. All the manipulations/engineering accomplished on the microorganisms since 2000 are described in detail along with the biosynthetic pathway enzymes, their sources, structures of the compounds, and yield of each product. In the second part of the review, post-modifications of flavonoids by four major reactions, namely glycosylations, methylations, hydroxylations and prenylations using recombinant strains are described. Copyright © 2016 Elsevier Inc. All rights reserved.

48 CFR 570.704 - Deviations to provisions and clauses.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 4 2014-10-01 2014-10-01 false Deviations to provisions and clauses. 570.704 Section 570.704 Federal Acquisition Regulations System GENERAL SERVICES... contracting officer also needs an approved deviation to modify the language of a provision or clause mandated...

48 CFR 570.704 - Deviations to provisions and clauses.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 4 2012-10-01 2012-10-01 false Deviations to provisions and clauses. 570.704 Section 570.704 Federal Acquisition Regulations System GENERAL SERVICES... contracting officer also needs an approved deviation to modify the language of a provision or clause mandated...

48 CFR 570.704 - Deviations to provisions and clauses.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Deviations to provisions and clauses. 570.704 Section 570.704 Federal Acquisition Regulations System GENERAL SERVICES... contracting officer also needs an approved deviation to modify the language of a provision or clause mandated...

48 CFR 570.704 - Deviations to provisions and clauses.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Deviations to provisions and clauses. 570.704 Section 570.704 Federal Acquisition Regulations System GENERAL SERVICES... contracting officer also needs an approved deviation to modify the language of a provision or clause mandated...

Importance sampling large deviations in nonequilibrium steady states. I.

PubMed

Ray, Ushnish; Chan, Garnet Kin-Lic; Limmer, David T

2018-03-28

Large deviation functions contain information on the stability and response of systems driven into nonequilibrium steady states and in such a way are similar to free energies for systems at equilibrium. As with equilibrium free energies, evaluating large deviation functions numerically for all but the simplest systems is difficult because by construction they depend on exponentially rare events. In this first paper of a series, we evaluate different trajectory-based sampling methods capable of computing large deviation functions of time integrated observables within nonequilibrium steady states. We illustrate some convergence criteria and best practices using a number of different models, including a biased Brownian walker, a driven lattice gas, and a model of self-assembly. We show how two popular methods for sampling trajectory ensembles, transition path sampling and diffusion Monte Carlo, suffer from exponentially diverging correlations in trajectory space as a function of the bias parameter when estimating large deviation functions. Improving the efficiencies of these algorithms requires introducing guiding functions for the trajectories.

Importance sampling large deviations in nonequilibrium steady states. I

NASA Astrophysics Data System (ADS)

Ray, Ushnish; Chan, Garnet Kin-Lic; Limmer, David T.

2018-03-01

Large deviation functions contain information on the stability and response of systems driven into nonequilibrium steady states and in such a way are similar to free energies for systems at equilibrium. As with equilibrium free energies, evaluating large deviation functions numerically for all but the simplest systems is difficult because by construction they depend on exponentially rare events. In this first paper of a series, we evaluate different trajectory-based sampling methods capable of computing large deviation functions of time integrated observables within nonequilibrium steady states. We illustrate some convergence criteria and best practices using a number of different models, including a biased Brownian walker, a driven lattice gas, and a model of self-assembly. We show how two popular methods for sampling trajectory ensembles, transition path sampling and diffusion Monte Carlo, suffer from exponentially diverging correlations in trajectory space as a function of the bias parameter when estimating large deviation functions. Improving the efficiencies of these algorithms requires introducing guiding functions for the trajectories.

Dissolved DMSO production via biological and photochemical oxidation of dissolved DMS in the Ross Sea, Antarctica

NASA Astrophysics Data System (ADS)

del Valle, Daniela A.; Kieber, David J.; Toole, Dierdre A.; Bisgrove, John; Kiene, Ronald P.

2009-02-01

Dimethylsulfoxide (DMSO) is an important degradation product of the climate-influencing gas dimethylsulfide (DMS). In the Ross Sea, Antarctica, dissolved DMSO (DMSOd) concentrations exhibited substantial seasonal and vertical variations. Surface water DMSOd concentrations in pre-bloom waters were very low (<1 nM) but increased rapidly up to 41 nM during the spring Phaeocystis antarctica bloom (late November). Increases in DMSOd concentrations lagged by several days increases in DMS concentrations. Although DMSOd concentrations reached relatively high levels during the spring bloom, concentrations were generally higher (36.3-60.6 nM) during summer (January), even though phytoplankton biomass and DMS concentrations had decreased by that time. During both seasons, DMSOd concentrations were substantially higher within the surface mixed layer than below it. DMSOd production from biological DMS consumption (BDMSC) was higher during late November (3.4-5.2 nM d -1) than during the summer (0.7-2.4 nM d -1); therefore, production via BDMSC alone could not explain the higher DMSOd concentrations encountered during the summer. Mixed layer-integrated DMSOd production from BDMSC was 2.5-13.7 times greater than production from dissolved DMS photolysis during the P. antarctica bloom, while photolysis contributed 1.3 times more DMSO than BDMSC before the bloom. The DMSO yield from BDMSC was consistently higher within the upper mixed layer than at depths below. Experimental incubations with water from the mixed layer showed that exposure to full spectrum sunlight for 72 h caused an increase in the DMSO yield whereas exposure to only photosynthetically active radiation did not. This suggests that ultraviolet radiation is a potential factor shifting the fate of biologically consumed DMS toward DMSO. In general, the highest DMSO yields from BDMSC were in samples with slow biological DMS turnover, whereas fast turnover favored sulfate rather than DMSO as a major end-product. This study

The yeast stands alone: the future of protein biologic production.

PubMed

Love, Kerry R; Dalvie, Neil C; Love, J Christopher

2017-12-22

Yeasts are promising alternative hosts for the manufacturing of recombinant protein therapeutics because they simply and efficiently meet needs for both platform and small-market drugs. Fast accumulation of biomass and low-cost media reduce the cost-of-goods when using yeast, which in turn can enable agile, small-volume manufacturing facilities. Small, tractable yeast genomes are amenable to rapid process development, facilitating strain and product quality by design. Specifically, Pichia pastoris is becoming a widely accepted yeast for biopharmaceutical manufacturing in much of the world owing to a clean secreted product and the rapidly expanding understanding of its cell biology as a host organism. We advocate for a near term partnership spanning industry and academia to promote open source, timely development of yeast hosts. Copyright © 2017. Published by Elsevier Ltd.

Clinical Implications of Septal Deviation in Lateralized Olfaction

PubMed Central

Choi, Yoon-Seok; Ryu, Yoon-Jong; Rhee, Jihye; Seok, Jungirl; Han, Sungjun; Jin, Hong Ryul; Kim, Dae Woo

2016-01-01

Objectives Results of butanol threshold tests (BTTs) have shown that birhinal olfaction tends to converge toward monorhinal olfaction of the dominant nostril. However, birhinal olfaction may also be worse than dominant-side monorhinal olfaction. The goal of our study was to investigate the effect of deviated nasal septum on birhinal olfaction in patients with lateralized olfaction and to examine the effect of septoplasty in these patients. Methods A retrospective study with planned data collection was conducted in 518 patients who underwent BTTs. Lateralized olfaction was defined as monorhinal BTT scores that differed by >2 between sides. Underestimated birhinal olfaction was defined as a birhinal BTT score >2 lower than the dominant nostril monorhinal BTT score. Patients with lateralized olfaction were divided into 2 groups: group 1, underestimated birhinal olfaction; and group 2, without underestimated birhinal olfaction. Results Among 518 patients, 112 with lateralized olfaction were enrolled in this study. Group 1 included 23 patients (20.5%) and group 2 included 89 patients (79.5%). The severity of septal deviation (ratio of the distance of narrower side to wider side) did not differ between the 2 groups. Septal deviation to the dominant nostril was more common in group 1 than group 2 (73.9% vs. 37.6%; P=0.002). Five patients with septal deviation to the dominant nostril with underestimated birhinal olfaction underwent septoplasty. Improved lateralized olfaction occurred in all 5 patients postoperatively (P=0.041). Conclusion Septal deviation of the dominant nostril in patients with lateralized olfaction is associated with underestimated birhinal olfaction. Septoplasty may improve olfaction by increasing airflow in the dominant olfactory side. PMID:26976025

Standard Deviation for Small Samples

ERIC Educational Resources Information Center

Joarder, Anwar H.; Latif, Raja M.

2006-01-01

Neater representations for variance are given for small sample sizes, especially for 3 and 4. With these representations, variance can be calculated without a calculator if sample sizes are small and observations are integers, and an upper bound for the standard deviation is immediate. Accessible proofs of lower and upper bounds are presented for…

A review of biological delignification and detoxification methods for lignocellulosic bioethanol production.

PubMed

Moreno, Antonio D; Ibarra, David; Alvira, Pablo; Tomás-Pejó, Elia; Ballesteros, Mercedes

2015-01-01

Future biorefineries will integrate biomass conversion processes to produce fuels, power, heat and value-added chemicals. Due to its low price and wide distribution, lignocellulosic biomass is expected to play an important role toward this goal. Regarding renewable biofuel production, bioethanol from lignocellulosic feedstocks is considered the most feasible option for fossil fuels replacement since these raw materials do not compete with food or feed crops. In the overall process, lignin, the natural barrier of the lignocellulosic biomass, represents an important limiting factor in biomass digestibility. In order to reduce the recalcitrant structure of lignocellulose, biological pretreatments have been promoted as sustainable and environmentally friendly alternatives to traditional physico-chemical technologies, which are expensive and pollute the environment. These approaches include the use of diverse white-rot fungi and/or ligninolytic enzymes, which disrupt lignin polymers and facilitate the bioconversion of the sugar fraction into ethanol. As there is still no suitable biological pretreatment technology ready to scale up in an industrial context, white-rot fungi and/or ligninolytic enzymes have also been proposed to overcome, in a separated or in situ biodetoxification step, the effect of the inhibitors produced by non-biological pretreatments. The present work reviews the latest studies regarding the application of different microorganisms or enzymes as useful and environmentally friendly delignification and detoxification technologies for lignocellulosic biofuel production. This review also points out the main challenges and possible ways to make these technologies a reality for the bioethanol industry.

Annual net community production and the biological carbon flux in the ocean

NASA Astrophysics Data System (ADS)

Emerson, Steven

2014-01-01

The flux of biologically produced organic matter from the surface ocean (the biological pump), over an annual cycle, is equal to the annual net community production (ANCP). Experimental determinations of ANCP at ocean time series sites using a variety of different metabolite mass balances have made it possible to evaluate the accuracy of sediment trap fluxes and satellite-determined ocean carbon export. ANCP values at the Hawaii Ocean Time-series (HOT), the Bermuda Atlantic Time-series Study (BATS), Ocean Station Papa (OSP) are 3 ± 1 mol C m-2 yr-1—much less variable than presently suggested by satellite remote sensing measurements and global circulation models. ANCP determined from mass balances at these locations are 3-4 times particulate organic carbon fluxes measured in sediment traps. When the roles of dissolved organic carbon (DOC) flux, zooplankton migration, and depth-dependent respiration are considered these differences are reconciled at HOT and OSP but not at BATS, where measured particulate fluxes are about 3 times lower than expected. Even in the cases where sediment trap fluxes are accurate, it is not possible to "scale up" these measurements to determine ANCP without independent determinations of geographically variable DOC flux and zooplankton migration. Estimates of ANCP from satellite remote sensing using net primary production determined by the carbon-based productivity model suggests less geographic variability than its predecessor (the vertically generalized productivity model) and brings predictions at HOT and OSP closer to measurements; however, satellite-predicted ANCP at BATS is still 3 times too low.

Efficiency and large deviations in time-asymmetric stochastic heat engines

DOE PAGES

Gingrich, Todd R.; Rotskoff, Grant M.; Vaikuntanathan, Suriyanarayanan; ...

2014-10-24

In a stochastic heat engine driven by a cyclic non-equilibrium protocol, fluctuations in work and heat give rise to a fluctuating efficiency. Using computer simulations and tools from large deviation theory, we have examined these fluctuations in detail for a model two-state engine. We find in general that the form of efficiency probability distributions is similar to those described by Verley et al (2014 Nat. Commun. 5 4721), in particular featuring a local minimum in the long-time limit. In contrast to the time-symmetric engine protocols studied previously, however, this minimum need not occur at the value characteristic of a reversible Carnot engine. Furthermore, while the local minimum may reside at the global minimum of a large deviation rate function, it does not generally correspond to the least likely efficiency measured over finite time. Lastly, we introduce a general approximation for the finite-time efficiency distribution,more » $$P(\\eta )$$, based on large deviation statistics of work and heat, that remains very accurate even when $$P(\\eta )$$ deviates significantly from its large deviation form.« less

Triangular Resection of the Upper Lateral Cartilage for Middle Vault Deviation.

PubMed

Ryu, Gwanghui; Seo, Min Young; Lee, Kyung Eun; Hong, Sang Duk; Chung, Seung-Kyu; Dhong, Hun-Jong; Kim, Hyo Yeol

2018-06-02

Middle vault deviation has a significant effect on the aesthetic and functional aspects of the nose, and its management continues to be a challenge. Spreader graft and its modification techniques have been focused, but there has been scarce consideration for removing surplus portion and balancing the upper lateral cartilage (ULC). This study aimed to report the newly invented triangular-shaped resection technique ("triangular resection") of the ULC and to evaluate its efficacy for correcting middle vault deviation. A retrospective study included 17 consecutive patients who presented with middle vault deviation and underwent septorhinoplasty by using triangular resection at a tertiary academic hospital from February 2014 and March 2016. Their outcomes were evaluated pre- and postoperatively including medical photographs, acoustic rhinometry and subjective nasal obstruction using a 7-point Likert scale. The immediate outcomes were evaluated around 1 month after surgery, and long-term outcomes were available in 12 patients; the mean follow-up period was 9.1 months. Nasal tip deviation angle was reduced from 5.66º to 2.37º immediately (P<0.001). Middle vault deviation also improved from 169.50º to 177.24º (P<0.001). Long-term results were 2.49º (P=0.015) for nasal tip deviation and 178.68º (P=0.002) for middle vault deviation. The aesthetic outcome involved a complete correction in eight patients (47.1%), a minimally visible deviation in seven patients (41.2%) and a remaining residual deviation in two patients (11.8%). Pre- and postoperative minimal cross-sectional areas (summation of the right and left sides) were 0.86 and 1.07, respectively (P=0.021). Fifteen patients answered about their nasal obstruction symptoms and the median symptom score had alleviated from 6.0 to 3.0 (P=0.004). Triangular resection of the ULC is a simple and effective method for correcting middle vault deviation and balancing the ULCs without complications as internal nasal valve

45 CFR 63.19 - Budget revisions and minor deviations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Budget revisions and minor deviations. 63.19 Section 63.19 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GRANT PROGRAMS... Budget revisions and minor deviations. Pursuant to § 74.102(d) of this title, paragraphs (b)(3) and (b)(4...

45 CFR 63.19 - Budget revisions and minor deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Budget revisions and minor deviations. 63.19 Section 63.19 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GRANT PROGRAMS... Budget revisions and minor deviations. Pursuant to § 74.102(d) of this title, paragraphs (b)(3) and (b)(4...

Neoclassical canons of facial beauty: Do we see the deviations?

PubMed

Pavlic, Andrej; Trinajstic Zrinski, Magda; Katic, Visnja; Spalj, Stjepan

2017-05-01

To explore the presence of neoclassical canons of facial beauty among young people in Croatia and to question possible psychosocial repercussions occurring in those who demonstrate deviations in relation to canons. The study was cross-sectional and the sample included 249 subjects (60% female) aged 12-39 (median 20). Their en face and profile photographs were taken in Natural Head Position. Photogrammetry included analysis of nine neoclassical canons of facial beauty originating from the Renaissance. Psychosocial issues were assessed using the Self-Esteem Scale, Big Five Inventory and three domains of Orthognathic Quality of Life Questionnaire. Significant deviations from neoclassical facial beauty canons were observed in 55-65% of adolescents and young adults. Gender and age showed no relation to deviations. The deviations from canons that influenced the quality of life were mainly those related to vertical facial proportions and demonstrated increased facial aesthetics concern and social impact, and higher self-reported treatment need (p < 0.05). Deviations from canons were not related to self-esteem but a decrease in openness, agreeableness and neuroticism was observed. Neoclassical canons were not valid for the majority of adolescents and young adults in Croatia. Only deviations from some canons appear to provoke mild psychosocial repercussions. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Changes in deviation of absorbed dose to water among users by chamber calibration shift.

PubMed

Katayose, Tetsurou; Saitoh, Hidetoshi; Igari, Mitsunobu; Chang, Weishan; Hashimoto, Shimpei; Morioka, Mie

2017-07-01

The JSMP01 dosimetry protocol had adopted the provisional 60 Co calibration coefficient [Formula: see text], namely, the product of exposure calibration coefficient N C and conversion coefficient k D,X . After that, the absorbed dose to water D w  standard was established, and the JSMP12 protocol adopted the [Formula: see text] calibration. In this study, the influence of the calibration shift on the measurement of D w among users was analyzed. The intercomparison of the D w using an ionization chamber was annually performed by visiting related hospitals. Intercomparison results before and after the calibration shift were analyzed, the deviation of D w among users was re-evaluated, and the cause of deviation was estimated. As a result, the stability of LINAC, calibration of the thermometer and barometer, and collection method of ion recombination were confirmed. The statistical significance of standard deviation of D w was not observed, but that of difference of D w among users was observed between N C and [Formula: see text] calibration. Uncertainty due to chamber-to-chamber variation was reduced by the calibration shift, consequently reducing the uncertainty among users regarding D w . The result also pointed out uncertainty might be reduced by accurate and detailed instructions on the setup of an ionization chamber.

Note Onset Deviations as Musical Piece Signatures

PubMed Central

Serrà, Joan; Özaslan, Tan Hakan; Arcos, Josep Lluis

2013-01-01

A competent interpretation of a musical composition presents several non-explicit departures from the written score. Timing variations are perhaps the most important ones: they are fundamental for expressive performance and a key ingredient for conferring a human-like quality to machine-based music renditions. However, the nature of such variations is still an open research question, with diverse theories that indicate a multi-dimensional phenomenon. In the present study, we consider event-shift timing variations and show that sequences of note onset deviations are robust and reliable predictors of the musical piece being played, irrespective of the performer. In fact, our results suggest that only a few consecutive onset deviations are already enough to identify a musical composition with statistically significant accuracy. We consider a mid-size collection of commercial recordings of classical guitar pieces and follow a quantitative approach based on the combination of standard statistical tools and machine learning techniques with the semi-automatic estimation of onset deviations. Besides the reported results, we believe that the considered materials and the methodology followed widen the testing ground for studying musical timing and could open new perspectives in related research fields. PMID:23935971

Note onset deviations as musical piece signatures.

PubMed

Serrà, Joan; Özaslan, Tan Hakan; Arcos, Josep Lluis

2013-01-01

A competent interpretation of a musical composition presents several non-explicit departures from the written score. Timing variations are perhaps the most important ones: they are fundamental for expressive performance and a key ingredient for conferring a human-like quality to machine-based music renditions. However, the nature of such variations is still an open research question, with diverse theories that indicate a multi-dimensional phenomenon. In the present study, we consider event-shift timing variations and show that sequences of note onset deviations are robust and reliable predictors of the musical piece being played, irrespective of the performer. In fact, our results suggest that only a few consecutive onset deviations are already enough to identify a musical composition with statistically significant accuracy. We consider a mid-size collection of commercial recordings of classical guitar pieces and follow a quantitative approach based on the combination of standard statistical tools and machine learning techniques with the semi-automatic estimation of onset deviations. Besides the reported results, we believe that the considered materials and the methodology followed widen the testing ground for studying musical timing and could open new perspectives in related research fields.

A hybrid method with deviational particles for spatial inhomogeneous plasma

NASA Astrophysics Data System (ADS)

Yan, Bokai

2016-03-01

In this work we propose a Hybrid method with Deviational Particles (HDP) for a plasma modeled by the inhomogeneous Vlasov-Poisson-Landau system. We split the distribution into a Maxwellian part evolved by a grid based fluid solver and a deviation part simulated by numerical particles. These particles, named deviational particles, could be both positive and negative. We combine the Monte Carlo method proposed in [31], a Particle in Cell method and a Macro-Micro decomposition method [3] to design an efficient hybrid method. Furthermore, coarse particles are employed to accelerate the simulation. A particle resampling technique on both deviational particles and coarse particles is also investigated and improved. This method is applicable in all regimes and significantly more efficient compared to a PIC-DSMC method near the fluid regime.

Sub-grain induced crack deviation in multi-crystalline silicon

NASA Astrophysics Data System (ADS)

Zhao, Lv; Nelias, Daniel; Bardel, Didier; Wang, Meng; Marie, Benoit

2017-06-01

The fracture process in crystalline silicon is dictated by energy dissipation. Here, we show that sub-grains can deviate the crack path from the most energetically favorable ( 111) plane. Albeit a small misorientation across the sub-grain boundary is identified, upon entering into the sub-grain region, the crack either slightly deviates from the ideal ( 111) plane or directly chooses the secondly most favorable ( 110) one. We propose that the deviation is related to the dislocation core in the ( 111) crystal plane, which leads to a discontinuous atom debonding process and consequently a pronounced lattice trapping. In this circumstance, localized crystal defects prevail in the fracture process of silicon, while energetical criterion fails to interpret the crack path.

Manufacturing of curd products of increased biological value for the elderly from dried components.

PubMed

Zabodalova, Ludmila A; Belozerova, Maria S; Evstigneeva, Tatiana N

2018-01-01

In recent years, the number of elderly people has increased, and the diseases that arise in old age are associated, amongst other factors, with malnutrition. In the elderly, the need for primary nutrients and energy changes, so the development of food products intended for this particular group of people is becom- ing increasingly important. The purpose of this research is to work out the composition of and technology for producing low-fat curd products from raw milk and vegetable components. The developed products can be used for their gerodietetic properties, because nutritional and energy needs in the elderly were taken into account when designing the product. The curd product was manufactured from skimmed dried milk (SDM), soy isolate protein (SIP) and spelt grain. Optimal conditions for the recombination of SIP were determined. The influence of mass fraction of SIP on the properties of the clot and the end product was studied. The degree of dispersion of the grain component was determined, from the organoleptic evaluation of samples of the mixture, and the optimum method of addition was chosen. The method of adding cooked spelt into the clot after pressing was chosen. Harrington’s generalized desirability function was used for the calculation of the optimum mass frac- tion of the grain component in the end product. The formulation and technology for a curd product based on dry ingredients were determined. The amino acid composition and content of essential components in the developed product were determined, and the biological and nutritional value were calculated. The use of dry ingredients for the production of a curd product makes it possible to manufac- ture the product in the absence of raw milk. The formulation of the product is designed taking into account the needs of the body in old age. The incorporation of spelt increases the biological value of the curd product to 81.5%.

Industrial systems biology and its impact on synthetic biology of yeast cell factories.

PubMed

Fletcher, Eugene; Krivoruchko, Anastasia; Nielsen, Jens

2016-06-01

Engineering industrial cell factories to effectively yield a desired product while dealing with industrially relevant stresses is usually the most challenging step in the development of industrial production of chemicals using microbial fermentation processes. Using synthetic biology tools, microbial cell factories such as Saccharomyces cerevisiae can be engineered to express synthetic pathways for the production of fuels, biopharmaceuticals, fragrances, and food flavors. However, directing fluxes through these synthetic pathways towards the desired product can be demanding due to complex regulation or poor gene expression. Systems biology, which applies computational tools and mathematical modeling to understand complex biological networks, can be used to guide synthetic biology design. Here, we present our perspective on how systems biology can impact synthetic biology towards the goal of developing improved yeast cell factories. Biotechnol. Bioeng. 2016;113: 1164-1170. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Impact of synthetic biology and metabolic engineering on industrial production of fine chemicals.

PubMed

Jullesson, David; David, Florian; Pfleger, Brian; Nielsen, Jens

2015-11-15

Industrial bio-processes for fine chemical production are increasingly relying on cell factories developed through metabolic engineering and synthetic biology. The use of high throughput techniques and automation for the design of cell factories, and especially platform strains, has played an important role in the transition from laboratory research to industrial production. Model organisms such as Saccharomyces cerevisiae and Escherichia coli remain widely used host strains for industrial production due to their robust and desirable traits. This review describes some of the bio-based fine chemicals that have reached the market, key metabolic engineering tools that have allowed this to happen and some of the companies that are currently utilizing these technologies for developing industrial production processes. Copyright © 2015 Elsevier Inc. All rights reserved.

Laser-initiated decomposition products of indocyanine green (ICG) and carbon black sensitized biological tissues

NASA Astrophysics Data System (ADS)

Kokosa, John M.; Przyjazny, Andrzej; Bartels, Kenneth E.; Motamedi, Massoud; Hayes, Donald J.; Wallace, David B.; Frederickson, Christopher J.

1997-05-01

Organic dyes have found increasing use a s sensitizers in laser surgical procedures, due to their high optical absorbances. Little is known, however, about the nature of the degradation products formed when these dyes are irradiated with a laser. Previous work in our laboratories has shown that irradiation of polymeric and biological tissues with CO2 and Nd:YAG lasers produces a host of volatile and semivolatile by-products, some of which are known to be potential carcinogens. This work focuses on the identification of the chemical by-products formed by diode laser and Nd:YAG laser irradiation of indocyanine green (ICG) and carbon black based ink sensitized tissues, including bone, tendon and sheep's teeth. Samples were mounted in a 0.5-L Pyrex sample chamber equipped with quartz optical windows, charcoal filtered air inlet and an outlet attached to an appropriate sample trap and a constant flow pump. By-products were analyzed by GC/MS and HPLC. Volatiles identified included benzene and formaldehyde. Semi-volatiles included traces of polycyclic aromatics, arising from the biological matrix and inks, as well as fragments of ICG and the carbon ink components. The significance of these results will be discussed, including the necessity of using appropriate evacuation devices when utilizing lasers for surgical procedures.

A living foundry for Synthetic Biological Materials: A synthetic biology roadmap to new advanced materials.

PubMed

Le Feuvre, Rosalind A; Scrutton, Nigel S

2018-06-01

Society is on the cusp of harnessing recent advances in synthetic biology to discover new bio-based products and routes to their affordable and sustainable manufacture. This is no more evident than in the discovery and manufacture of Synthetic Biological Materials , where synthetic biology has the capacity to usher in a new Materials from Biology era that will revolutionise the discovery and manufacture of innovative synthetic biological materials. These will encompass novel, smart, functionalised and hybrid materials for diverse applications whose discovery and routes to bio-production will be stimulated by the fusion of new technologies positioned across physical, digital and biological spheres. This article, which developed from an international workshop held in Manchester, United Kingdom, in 2017 [1], sets out to identify opportunities in the new materials from biology era. It considers requirements, early understanding and foresight of the challenges faced in delivering a Discovery to Manufacturing Pipeline for synthetic biological materials using synthetic biology approaches. This challenge spans the complete production cycle from intelligent and predictive design, fabrication, evaluation and production of synthetic biological materials to new ways of bringing these products to market. Pathway opportunities are identified that will help foster expertise sharing and infrastructure development to accelerate the delivery of a new generation of synthetic biological materials and the leveraging of existing investments in synthetic biology and advanced materials research to achieve this goal.

Biological evaluation of nanosilver incorporated cellulose pulp for hygiene products.

PubMed

Kavitha Sankar, P C; Ramakrishnan, Reshmi; Rosemary, M J

2016-04-01

Cellulose pulp has a visible market share in personal hygiene products such as sanitary napkins and baby diapers. However it offers good surface for growth of microorganisms. Huge amount of research is going on in developing hygiene products that do not initiate microbial growth. The objective of the present work is to produce antibacterial cellulose pulp by depositing silver nanopowder on the cellulose fiber. The silver nanoparticles used were of less than 100 nm in size and were characterised using transmission electron microscopy and X-ray powder diffraction studies. Antibacterial activity of the functionalized cellulose pulp was proved by JIS L 1902 method. The in-vitro cytotoxicity, in-vivo vaginal irritation and intracutaneous reactivity studies were done with silver nanopowder incorporated cellulose pulp for introducing a new value added product to the market. Cytotoxicity evaluation suggested that the silver nanoparticle incorporated cellulose pulp is non-cytotoxic. No irritation and skin sensitization were identified in animals tested with specific extracts prepared from the test material in the in-vivo experiments. The results indicated that the silver nanopowder incorporated cellulose pulp meets the requirements of the standard practices recommended for evaluating the biological reactivity and has good biocompatibility, hence can be classified as a safe hygiene product. Copyright © 2015 Elsevier B.V. All rights reserved.

41 CFR 109-1.5304 - Deviations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... High Risk Personal Property § 109-1.5304 Deviations. (a) Life cycle control determinations. When the HFO approves a contractor program containing controls, other than life cycle control consistent with... Secretary for Procurement and Assistance Management. A HFO's decision not to provide life-cycle control...

41 CFR 109-1.5304 - Deviations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... High Risk Personal Property § 109-1.5304 Deviations. (a) Life cycle control determinations. When the HFO approves a contractor program containing controls, other than life cycle control consistent with... Secretary for Procurement and Assistance Management. A HFO's decision not to provide life-cycle control...

41 CFR 109-1.5304 - Deviations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... High Risk Personal Property § 109-1.5304 Deviations. (a) Life cycle control determinations. When the HFO approves a contractor program containing controls, other than life cycle control consistent with... Secretary for Procurement and Assistance Management. A HFO's decision not to provide life-cycle control...

41 CFR 109-1.5304 - Deviations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... High Risk Personal Property § 109-1.5304 Deviations. (a) Life cycle control determinations. When the HFO approves a contractor program containing controls, other than life cycle control consistent with... Secretary for Procurement and Assistance Management. A HFO's decision not to provide life-cycle control...

41 CFR 109-1.5304 - Deviations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... High Risk Personal Property § 109-1.5304 Deviations. (a) Life cycle control determinations. When the HFO approves a contractor program containing controls, other than life cycle control consistent with... Secretary for Procurement and Assistance Management. A HFO's decision not to provide life-cycle control...

Hormones in international meat production: biological, sociological and consumer issues.

PubMed

Galbraith, Hugh

2002-12-01

Beef and its products are an important source of nutrition in many human societies. Methods of production vary and include the use of hormonal compounds ('hormones') to increase growth and lean tissue with reduced fat deposition in cattle. The hormonal compounds are naturally occurring in animals or are synthetically produced xenobiotics and have oestrogenic (oestradiol-17beta and its esters; zeranol), androgenic (testosterone and esters; trenbolone acetate) or progestogenic (progesterone; melengestrol acetate) activity. The use of hormones as production aids is permitted in North American countries but is no longer allowed in the European Union (EU), which also prohibits the importation of beef and its products derived from hormone-treated cattle. These actions have resulted in a trade dispute between the two trading blocs. The major concern for EU authorities is the possibility of adverse effects on human consumers of residues of hormones and metabolites. Methods used to assess possible adverse effects are typical of those used by international agencies to assess acceptability of chemicals in human food. These include analysis of quantities present in the context of known biological activity and digestive, absorptive, post-absorptive and excretory processes. Particular considerations include the low quantities of hormonal compounds consumed in meat products and their relationships to endogenous production particularly in prepubertal children, enterohepatic inactivation, cellular receptor- and non-receptor-mediated effects and potential for interference with growth, development and physiological function in consumers. There is particular concern about the role of oestradiol-17beta as a carcinogen in certain tissues. Now subject to a 'permanent' EU ban, current evidence suggests that certain catechol metabolites may induce free-radical damage of DNA in cell and laboratory animal test systems. Classical oestrogen-receptor mediation is considered to stimulate

Biological Interactions of Nanomaterials

DTIC Science & Technology

2008-12-01

reagent contains the tetrazolium compound MTS and an electron coupling reagent ( phenazine ethosulfate; PES). The quantity of formazan product as...PES Phenazine ethosulfate PS Polysaccharide RET Rearranged during transfection ROS Reactive oxygen species SD Standard deviation SEM Scanning

Meat Production in a Feedlot System of Zebu—Holstein Steers and Heifers with Dairy Genetics: Productive and Biological Analyses

PubMed Central

Menezes, Gustavo Chamon de Castro; Valadares Filho, Sebastião de Campos; Ruas, José Reinaldo Mendes; Detmann, Edenio; Menezes, Arismar de Castro; Zanett, Diego; Mariz, Lays Débora Silva; Rennó, Luciana Navajas; da Silva Junior, Jarbas Miguel

2014-01-01

The aim of this study was to evaluate the productive and biological efficiency of steers and heifers from dairy genetics in a feedlot system in terms of meat production. Twenty-four steers and 24 heifers at 10 monthes of age, (3/4) Zebu × (1/4) Holstein were utilized. They were distributed over four feedlot times, 30, 60, 90, and 120 days with four replications for each sex, and were slaughtered at the end of each period. The productive and biological analyses were performed through comparative slaughter to determine the body composition. Heifers presented with greater intakes (P < 0.05) of dry matter in grams per kg of body weight. Steers presented with a greater (P < 0.05) final empty body weight, carcass gain, cold carcass weight, and meat proportion in the carcass; however, heifers presented with a greater subcutaneous fat thickness (P < 0.05) and, consequently, a greater (P < 0.05) fat proportion in the carcass. We conclude that steers are more efficient in their productive performance than heifers in a feedlot. For the finishing carcass fat cover, heifers need 90 days in the feedlot. The net energy requirements for maintenance are 67 kcal/EBW0.75/d, and the net requirements of energy (NEg) and protein (NPg) for gain can be estimated by the following equations: NEg(Mcal/d) = 0.067 × EBW0.75 × EBG1.095 and NPg = 162 × EBG − 5.62 × RE for the two sexes. PMID:25574483

A standard deviation selection in evolutionary algorithm for grouper fish feed formulation

NASA Astrophysics Data System (ADS)

Cai-Juan, Soong; Ramli, Razamin; Rahman, Rosshairy Abdul

2016-10-01

Malaysia is one of the major producer countries for fishery production due to its location in the equatorial environment. Grouper fish is one of the potential markets in contributing to the income of the country due to its desirable taste, high demand and high price. However, the demand of grouper fish is still insufficient from the wild catch. Therefore, there is a need to farm grouper fish to cater to the market demand. In order to farm grouper fish, there is a need to have prior knowledge of the proper nutrients needed because there is no exact data available. Therefore, in this study, primary data and secondary data are collected even though there is a limitation of related papers and 30 samples are investigated by using standard deviation selection in Evolutionary algorithm. Thus, this study would unlock frontiers for an extensive research in respect of grouper fish feed formulation. Results shown that the fitness of standard deviation selection in evolutionary algorithm is applicable. The feasible and low fitness, quick solution can be obtained. These fitness can be further predicted to minimize cost in farming grouper fish.

The scientific production in health and biological sciences of the top 20 Brazilian universities.

PubMed

Zorzetto, R; Razzouk, D; Dubugras, M T B; Gerolin, J; Schor, N; Guimarães, J A; Mari, J J

2006-12-01

Brazilian scientific output exhibited a 4-fold increase in the last two decades because of the stability of the investment in research and development activities and of changes in the policies of the main funding agencies. Most of this production is concentrated in public universities and research institutes located in the richest part of the country. Among all areas of knowledge, the most productive are Health and Biological Sciences. During the 1998-2002 period these areas presented heterogeneous growth ranging from 4.5% (Pharmacology) to 191% (Psychiatry), with a median growth rate of 47.2%. In order to identify and rank the 20 most prolific institutions in these areas, searches were made in three databases (DataCAPES, ISI and MEDLINE) which permitted the identification of 109,507 original articles produced by the 592 Graduate Programs in Health and Biological Sciences offered by 118 public universities and research institutes. The 20 most productive centers, ranked according to the total number of ISI-indexed articles published during the 1998-2003 period, produced 78.7% of the papers in these areas and are strongly concentrated in the Southern part of the country, mainly in São Paulo State.

40 CFR 62.14740 - What must I include in the deviation report?

Code of Federal Regulations, 2010 CFR

2010-07-01

... your unit deviated from the emission limitations or operating limit requirements. (b) The averaged and recorded data for those dates. (c) Duration and causes of each deviation from the emission limitations or... that deviated from the emission limitations or operating limits specified in this subpart, include the...

Dark-Fermentative Biological Hydrogen Production from Mixed Biowastes Using Defined Mixed Cultures.

PubMed

Patel, Sanjay K S; Lee, Jung-Kul; Kalia, Vipin C

2017-06-01

Biological hydrogen (H 2 ) production from the biowastes is widely recognized as a suitable alternative approach to utilize low cost feed instead of costly individual sugars. In the present investigation, pure and mixed biowastes were fermented by defined sets of mixed cultures for hydrolysis and H 2 production. Under batch conditions, up to 65, 67 and 70 L H 2 /kg total solids (2%, TS) were evolved from apple pomace (AP), onion peels (OP) and potato peels (PP) using a combination of hydrolytic mixed culture (MHC5) and mixed microbial cultures (MMC4 or MMC6), respectively. Among the different combinations of mixed biowastes including AP, OP, PP and pea-shells, the combination of OP and PP exhibited maximum H 2 production of 73 and 84 L/kg TS with MMC4 and MMC6, respectively. This study suggested that H 2 production can be effectively regulated by using defined sets of mixed cultures for hydrolysis and H 2 production from pure and mixed biowastes as feed even under unsterile conditions.

Evidence against a bacterial endotoxin masking effect in biologic drug products by limulus amebocyte lysate detection.

PubMed

Bolden, Jay S; Claerbout, Mark E; Miner, Matthew K; Murphy, Marie A; Smith, Kelly R; Warburton, Rob E

2014-01-01

The inability to detect endotoxin using compendia methods is a potential safety concern for patients due to the lack of endotoxin removal capabilities at the fill-finish stage in typical aseptic biologic drug product manufacturing. We have successfully demonstrated endotoxin challenge study recovery methodology using mammalian cell-produced biologic drug products and drug substances in citrate, histidine, phosphate, and sodium acetate buffer formulations containing polysorbate, challenged with an endotoxin analyte, for up to 6 months of storage. Successful recovery was similarly demonstrated for a preserved, peptide-containing drug product formulation. To isolate a potential masking-or low-endotoxin recovery-source, additional studies were performed to evaluate factors including product manufacturing contact surfaces, drug product matrix with and without polysorbate, individual matrix components, protein concentration, reagent suppliers, an orthogonal test method, and storage conditions. In all cases, acceptable recoveries were observed. Bacterial endotoxin is known to be chemically stable at physiological conditions. Purified endotoxin in aqueous conditions is likely to self-aggregate or bind to surfaces. Neither the nature of, nor the storage conditions of, the studied formulation matrices were shown experimentally to render the challenge endotoxin biologically inactive. The results highlight the importance of appropriate study design in assessing the recovery of endotoxins. Bacterial endotoxin is a Gram-negative bacterial cell wall component that is harmful to humans at threshold concentrations, and it is not expected to be in aseptically-produced pharmaceutical medicines. It has been suggested that endotoxin cannot be detected over time in certain biopharmaceutical drug product formulations containing citrate, phosphate, and polysorbate components via an unknown masking mechanism. We have generated and present data here that indicate that endotoxin can be

Statistics as Unbiased Estimators: Exploring the Teaching of Standard Deviation

ERIC Educational Resources Information Center

Wasserman, Nicholas H.; Casey, Stephanie; Champion, Joe; Huey, Maryann

2017-01-01

This manuscript presents findings from a study about the knowledge for and planned teaching of standard deviation. We investigate how understanding variance as an unbiased (inferential) estimator--not just a descriptive statistic for the variation (spread) in data--is related to teachers' instruction regarding standard deviation, particularly…

Complexities of follicle deviation during selection of a dominant follicle in Bos taurus heifers.

PubMed

Ginther, O J; Baldrighi, J M; Siddiqui, M A R; Araujo, E R

2016-11-01

Follicle deviation during a follicular wave is a continuation in growth rate of the dominant follicle (F1) and decreased growth rate of the largest subordinate follicle (F2). The reliability of using an F1 of 8.5 mm to represent the beginning of expected deviation for experimental purposes during waves 1 and 2 (n = 26 per wave) was studied daily in heifers. Each wave was subgrouped as follows: standard subgroup (F1 larger than F2 for 2 days preceding deviation and F2 > 7.0 mm on the day of deviation), undersized subgroup (F2 did not attain 7.0 mm by the day of deviation), and switched subgroup (F2 larger than F1 at least once on the 2 days before or on the day of deviation). For each wave, mean differences in diameter between F1 and F2 changed abruptly at expected deviation in the standard subgroup but began 1 day before expected deviation in the undersized and switched subgroups. Concentrations of FSH in the wave-stimulating FSH surge and an increase in LH centered on expected deviation did not differ among subgroups. Results for each wave indicated that (1) expected deviation (F1, 8.5 mm) was a reliable representation of actual deviation in the standard subgroup but not in the undersized and switched subgroups; (2) concentrations of the gonadotropins normalized to expected deviation were similar among the three subgroups, indicating that the day of deviation was related to diameter of F1 and not F2; and (3) defining an expected day of deviation for experimental use should consider both diameter of F1 and the characteristics of deviation. Copyright © 2016 Elsevier Inc. All rights reserved.

Biological production of products from waste gases

DOEpatents

Gaddy, James L.

2002-01-22

A method and apparatus are designed for converting waste gases from industrial processes such as oil refining, and carbon black, coke, ammonia, and methanol production, into useful products. The method includes introducing the waste gases into a bioreactor where they are fermented to various products, such as organic acids, alcohols, hydrogen, single cell protein, and salts of organic acids by anaerobic bacteria within the bioreactor. These valuable end products are then recovered, separated and purified.

A better norm-referenced grading using the standard deviation criterion.

PubMed

Chan, Wing-shing

2014-01-01

The commonly used norm-referenced grading assigns grades to rank-ordered students in fixed percentiles. It has the disadvantage of ignoring the actual distance of scores among students. A simple norm-referenced grading via standard deviation is suggested for routine educational grading. The number of standard deviation of a student's score from the class mean was used as the common yardstick to measure achievement level. Cumulative probability of a normal distribution was referenced to help decide the amount of students included within a grade. RESULTS of the foremost 12 students from a medical examination were used for illustrating this grading method. Grading by standard deviation seemed to produce better cutoffs in allocating an appropriate grade to students more according to their differential achievements and had less chance in creating arbitrary cutoffs in between two similarly scored students than grading by fixed percentile. Grading by standard deviation has more advantages and is more flexible than grading by fixed percentile for norm-referenced grading.

Quantifying prosthetic gait deviation using simple outcome measures

PubMed Central

Kark, Lauren; Odell, Ross; McIntosh, Andrew S; Simmons, Anne

2016-01-01

AIM: To develop a subset of simple outcome measures to quantify prosthetic gait deviation without needing three-dimensional gait analysis (3DGA). METHODS: Eight unilateral, transfemoral amputees and 12 unilateral, transtibial amputees were recruited. Twenty-eight able-bodied controls were recruited. All participants underwent 3DGA, the timed-up-and-go test and the six-minute walk test (6MWT). The lower-limb amputees also completed the Prosthesis Evaluation Questionnaire. Results from 3DGA were summarised using the gait deviation index (GDI), which was subsequently regressed, using stepwise regression, against the other measures. RESULTS: Step-length (SL), self-selected walking speed (SSWS) and the distance walked during the 6MWT (6MWD) were significantly correlated with GDI. The 6MWD was the strongest, single predictor of the GDI, followed by SL and SSWS. The predictive ability of the regression equations were improved following inclusion of self-report data related to mobility and prosthetic utility. CONCLUSION: This study offers a practicable alternative to quantifying kinematic deviation without the need to conduct complete 3DGA. PMID:27335814

78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 314 and 601... Approved Drugs and Biological Products; Correction and Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; correction and extension of comment period. SUMMARY: The Food and...

48 CFR 201.404 - Class deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., and the Defense Logistics Agency, may approve any class deviation, other than those described in 201...) Diminish any preference given small business concerns by the FAR or DFARS; or (D) Extend to requirements imposed by statute or by regulations of other agencies such as the Small Business Administration and the...

Metabolic engineering of microorganisms for biofuels production: from bugs to synthetic biology to fuels.

PubMed

Lee, Sung Kuk; Chou, Howard; Ham, Timothy S; Lee, Taek Soon; Keasling, Jay D

2008-12-01

The ability to generate microorganisms that can produce biofuels similar to petroleum-based transportation fuels would allow the use of existing engines and infrastructure and would save an enormous amount of capital required for replacing the current infrastructure to accommodate biofuels that have properties significantly different from petroleum-based fuels. Several groups have demonstrated the feasibility of manipulating microbes to produce molecules similar to petroleum-derived products, albeit at relatively low productivity (e.g. maximum butanol production is around 20 g/L). For cost-effective production of biofuels, the fuel-producing hosts and pathways must be engineered and optimized. Advances in metabolic engineering and synthetic biology will provide new tools for metabolic engineers to better understand how to rewire the cell in order to create the desired phenotypes for the production of economically viable biofuels.

Large deviations in the presence of cooperativity and slow dynamics

NASA Astrophysics Data System (ADS)

Whitelam, Stephen

2018-06-01

We study simple models of intermittency, involving switching between two states, within the dynamical large-deviation formalism. Singularities appear in the formalism when switching is cooperative or when its basic time scale diverges. In the first case the unbiased trajectory distribution undergoes a symmetry breaking, leading to a change in shape of the large-deviation rate function for a particular dynamical observable. In the second case the symmetry of the unbiased trajectory distribution remains unbroken. Comparison of these models suggests that singularities of the dynamical large-deviation formalism can signal the dynamical equivalent of an equilibrium phase transition but do not necessarily do so.

48 CFR 1352.219-71 - Notification to delay performance (Deviation).

Code of Federal Regulations, 2010 CFR

2010-10-01

... not begin performance under this purchase order until 2 working days have passed from the date of its... performance (Deviation). 1352.219-71 Section 1352.219-71 Federal Acquisition Regulations System DEPARTMENT OF....219-71 Notification to delay performance (Deviation). As prescribed in 48 CFR 1319.811-3(b), insert...

10 CFR 1017.5 - Requesting a deviation.

Code of Federal Regulations, 2010 CFR

2010-01-01

... create a potential or real vulnerability); or (3) An exception (i.e., an approved deviation from a requirement in these regulations for which DOE accepts the risk of a safeguards and security vulnerability...

Welding deviation detection algorithm based on extremum of molten pool image contour

NASA Astrophysics Data System (ADS)

Zou, Yong; Jiang, Lipei; Li, Yunhua; Xue, Long; Huang, Junfen; Huang, Jiqiang

2016-01-01

The welding deviation detection is the basis of robotic tracking welding, but the on-line real-time measurement of welding deviation is still not well solved by the existing methods. There is plenty of information in the gas metal arc welding(GMAW) molten pool images that is very important for the control of welding seam tracking. The physical meaning for the curvature extremum of molten pool contour is revealed by researching the molten pool images, that is, the deviation information points of welding wire center and the molten tip center are the maxima and the local maxima of the contour curvature, and the horizontal welding deviation is the position difference of these two extremum points. A new method of weld deviation detection is presented, including the process of preprocessing molten pool images, extracting and segmenting the contours, obtaining the contour extremum points, and calculating the welding deviation, etc. Extracting the contours is the premise, segmenting the contour lines is the foundation, and obtaining the contour extremum points is the key. The contour images can be extracted with the method of discrete dyadic wavelet transform, which is divided into two sub contours including welding wire and molten tip separately. The curvature value of each point of the two sub contour lines is calculated based on the approximate curvature formula of multi-points for plane curve, and the two points of the curvature extremum are the characteristics needed for the welding deviation calculation. The results of the tests and analyses show that the maximum error of the obtained on-line welding deviation is 2 pixels(0.16 mm), and the algorithm is stable enough to meet the requirements of the pipeline in real-time control at a speed of less than 500 mm/min. The method can be applied to the on-line automatic welding deviation detection.

The phonatory deviation diagram: a novel objective measurement of vocal function.

PubMed

Madazio, Glaucya; Leão, Sylvia; Behlau, Mara

2011-01-01

To identify the discriminative characteristics of the phonatory deviation diagram (PDD) in rough, breathy and tense voices. One hundred and ninety-six samples of normal and dysphonic voices from adults were submitted to perceptual auditory evaluation, focusing on the predominant vocal quality and the degree of deviation. Acoustic analysis was performed with the VoxMetria (CTS Informatica). Significant differences were observed between the dysphonic and normal groups (p < 0.001), and also between the breathy and rough samples (p = 0.044) and the breathy and tense samples (p < 0.001). All normal voices were positioned in the inferior left quadrant, 45% of the rough voices in the inferior right quadrant, 52.6% of the breathy voices in the superior right quadrant and 54.3% of the tense voices in the inferior left quadrant of the PDD. In the inferior left quadrant, 93.8% of voices with no deviation were located and 72.7% of voices with mild deviation; voices with moderate deviation were distributed in the inferior and superior right quadrants, the latter ones containing the most deviant voices and 80% of voices with severe deviation. The PDD was able to discriminate normal from dysphonic voices, and the distribution was related to the type and degree of voice alteration. Copyright © 2011 S. Karger AG, Basel.

Heat treatment of curdlan enhances the enzymatic production of biologically active β-(1,3)-glucan oligosaccharides.

PubMed

Kumagai, Yuya; Okuyama, Masayuki; Kimura, Atsuo

2016-08-01

Biologically active β-(1,3)-glucan oligosaccharides were prepared from curdlan using GH64 enzyme (KfGH64). KfGH64 showed low activity toward native curdlan; thereby pretreatment conditions of curdlan were evaluated. KfGH64 showed the highest activity toward curdlan with heat treatment. The most efficient pretreatment (90°C for 0.5h) converted approximately 60% of curdlan into soluble saccharides under the optimized enzyme reaction conditions (pH 5.5, 37°C, 100rpm mixing speed, 24h, and 10μg of KfGH64/1g of curdlan). The resulting products were predominantly laminaripentaose and a small amount of β-(1,3)-glucans with an average degree of polymerization (DP) of 13 and 130. The products did not contain small oligosaccharides (DP<5), indicating that the hydrolysis of heat-treated curdlan by KfGH64 is a suitable method for the production of biologically active β-(1,3)-glucan oligosaccharides. Copyright © 2016 Elsevier Ltd. All rights reserved.

Large Deviations: Advanced Probability for Undergrads

ERIC Educational Resources Information Center

Rolls, David A.

2007-01-01

In the branch of probability called "large deviations," rates of convergence (e.g. of the sample mean) are considered. The theory makes use of the moment generating function. So, particularly for sums of independent and identically distributed random variables, the theory can be made accessible to senior undergraduates after a first course in…

An integrated cell-free metabolic platform for protein production and synthetic biology

PubMed Central

Jewett, Michael C; Calhoun, Kara A; Voloshin, Alexei; Wuu, Jessica J; Swartz, James R

2008-01-01

Cell-free systems offer a unique platform for expanding the capabilities of natural biological systems for useful purposes, i.e. synthetic biology. They reduce complexity, remove structural barriers, and do not require the maintenance of cell viability. Cell-free systems, however, have been limited by their inability to co-activate multiple biochemical networks in a single integrated platform. Here, we report the assessment of biochemical reactions in an Escherichia coli cell-free platform designed to activate natural metabolism, the Cytomim system. We reveal that central catabolism, oxidative phosphorylation, and protein synthesis can be co-activated in a single reaction system. Never before have these complex systems been shown to be simultaneously activated without living cells. The Cytomim system therefore promises to provide the metabolic foundation for diverse ab initio cell-free synthetic biology projects. In addition, we describe an improved Cytomim system with enhanced protein synthesis yields (up to 1200 mg/l in 2 h) and lower costs to facilitate production of protein therapeutics and biochemicals that are difficult to make in vivo because of their toxicity, complexity, or unusual cofactor requirements. PMID:18854819

Minimization of deviations of gear real tooth surfaces determined by coordinate measurements

NASA Technical Reports Server (NTRS)

Litvin, F. L.; Kuan, C.; Wang, J.-C.; Handschuh, R. F.; Masseth, J.; Maruyama, N.

1992-01-01

The deviations of a gear's real tooth surface from the theoretical surface are determined by coordinate measurements at the grid of the surface. A method was developed to transform the deviations from Cartesian coordinates to those along the normal at the measurement locations. Equations are derived that relate the first order deviations with the adjustment to the manufacturing machine-tool settings. The deviations of the entire surface are minimized. The minimization is achieved by application of the least-square method for an overdetermined system of linear equations. The proposed method is illustrated with a numerical example for hypoid gear and pinion.

The great 2012 Arctic Ocean summer cyclone enhanced biological productivity on the shelves

PubMed Central

Zhang, Jinlun; Ashjian, Carin; Campbell, Robert; Hill, Victoria; Spitz, Yvette H; Steele, Michael

2014-01-01

[1] A coupled biophysical model is used to examine the impact of the great Arctic cyclone of early August 2012 on the marine planktonic ecosystem in the Pacific sector of the Arctic Ocean (PSA). Model results indicate that the cyclone influences the marine planktonic ecosystem by enhancing productivity on the shelves of the Chukchi, East Siberian, and Laptev seas during the storm. Although the cyclone's passage in the PSA lasted only a few days, the simulated biological effects on the shelves last 1 month or longer. At some locations on the shelves, primary productivity (PP) increases by up to 90% and phytoplankton biomass by up to 40% in the wake of the cyclone. The increase in zooplankton biomass is up to 18% on 31 August and remains 10% on 15 September, more than 1 month after the storm. In the central PSA, however, model simulations indicate a decrease in PP and plankton biomass. The biological gain on the shelves and loss in the central PSA are linked to two factors. (1) The cyclone enhances mixing in the upper ocean, which increases nutrient availability in the surface waters of the shelves; enhanced mixing in the central PSA does not increase productivity because nutrients there are mostly depleted through summer draw down by the time of the cyclone's passage. (2) The cyclone also induces divergence, resulting from the cyclone's low-pressure system that drives cyclonic sea ice and upper ocean circulation, which transports more plankton biomass onto the shelves from the central PSA. The simulated biological gain on the shelves is greater than the loss in the central PSA, and therefore, the production on average over the entire PSA is increased by the cyclone. Because the gain on the shelves is offset by the loss in the central PSA, the average increase over the entire PSA is moderate and lasts only about 10 days. The generally positive impact of cyclones on the marine ecosystem in the Arctic, particularly on the shelves, is likely to grow with increasing

The great 2012 Arctic Ocean summer cyclone enhanced biological productivity on the shelves.

PubMed

Zhang, Jinlun; Ashjian, Carin; Campbell, Robert; Hill, Victoria; Spitz, Yvette H; Steele, Michael

2014-01-01

[1] A coupled biophysical model is used to examine the impact of the great Arctic cyclone of early August 2012 on the marine planktonic ecosystem in the Pacific sector of the Arctic Ocean (PSA). Model results indicate that the cyclone influences the marine planktonic ecosystem by enhancing productivity on the shelves of the Chukchi, East Siberian, and Laptev seas during the storm. Although the cyclone's passage in the PSA lasted only a few days, the simulated biological effects on the shelves last 1 month or longer. At some locations on the shelves, primary productivity (PP) increases by up to 90% and phytoplankton biomass by up to 40% in the wake of the cyclone. The increase in zooplankton biomass is up to 18% on 31 August and remains 10% on 15 September, more than 1 month after the storm. In the central PSA, however, model simulations indicate a decrease in PP and plankton biomass. The biological gain on the shelves and loss in the central PSA are linked to two factors. (1) The cyclone enhances mixing in the upper ocean, which increases nutrient availability in the surface waters of the shelves; enhanced mixing in the central PSA does not increase productivity because nutrients there are mostly depleted through summer draw down by the time of the cyclone's passage. (2) The cyclone also induces divergence, resulting from the cyclone's low-pressure system that drives cyclonic sea ice and upper ocean circulation, which transports more plankton biomass onto the shelves from the central PSA. The simulated biological gain on the shelves is greater than the loss in the central PSA, and therefore, the production on average over the entire PSA is increased by the cyclone. Because the gain on the shelves is offset by the loss in the central PSA, the average increase over the entire PSA is moderate and lasts only about 10 days. The generally positive impact of cyclones on the marine ecosystem in the Arctic, particularly on the shelves, is likely to grow with increasing

Large deviation function for a driven underdamped particle in a periodic potential

NASA Astrophysics Data System (ADS)

Fischer, Lukas P.; Pietzonka, Patrick; Seifert, Udo

2018-02-01

Employing large deviation theory, we explore current fluctuations of underdamped Brownian motion for the paradigmatic example of a single particle in a one-dimensional periodic potential. Two different approaches to the large deviation function of the particle current are presented. First, we derive an explicit expression for the large deviation functional of the empirical phase space density, which replaces the level 2.5 functional used for overdamped dynamics. Using this approach, we obtain several bounds on the large deviation function of the particle current. We compare these to bounds for overdamped dynamics that have recently been derived, motivated by the thermodynamic uncertainty relation. Second, we provide a method to calculate the large deviation function via the cumulant generating function. We use this method to assess the tightness of the bounds in a numerical case study for a cosine potential.

Syntactic Deviations in the Novel "The Sound and the Fury"

ERIC Educational Resources Information Center

Alirezazadeh, Pooria; Talebinezhad, Mohammad Reza

2014-01-01

This article looks at William Faulkner's work "The Sound and the Fury." The goals are to investigate different types of syntactic deviations in the novel, and how these deviations helped the writer to create a literary work in the field of modernist literature and stream of consciousness. To this end, the theoretical framework for…

Gait Deviations in Children With Osteogenesis Imperfecta Type I.

PubMed

Garman, Christina R; Graf, Adam; Krzak, Joseph; Caudill, Angela; Smith, Peter; Harris, Gerald

2017-08-02

Osteogenesis imperfecta (OI) is a congenital connective tissue disorder often characterized by orthopaedic complications that impact normal gait. As such, mobility is of particular interest in the OI population as it is associated with multiple aspects of participation and quality of life. The purpose of the current study was to identify and describe common gait deviations in a large sample of individuals with type I OI and speculate the etiology with a goal of improving function. Gait analysis was performed on 44 subjects with type I (11.7±3.08 y old) and 30 typically developing controls (9.54±3.1 y old ). Spatial temporal, kinematic, and kinetic gait data were calculated from the Vicon Plug-in-Gait Model. Musculoskeletal modeling of the muscle tendon lengths (MTL) was done in OpenSim 3.3 to evaluate the MTL of the gastrocnemius and gluteus maximus. The gait deviation index, a dimensionless parameter that evaluates the deviation of 9 kinematic gait parameters from a control database, was also calculated. Walking speed, single support time, stride, and step length were lower and double support time was higher in the OI group. The gait deviation index score was lower and external hip rotation angle was higher in the OI group. Peak hip flexor, knee extensor and ankle plantarflexor moments, and power generation at the ankle were lower in the OI group. MTL analysis revealed no significant length discrepancies between the OI group and the typically developing group. Together, these findings provide a comprehensive description of gait characteristics among a group of individuals with type I OI. Such data inform clinicians about specific gait deviations in this population allowing clinicians to recommend more focused interventions. Level III-case-control study.

A Taxonomy of Delivery and Documentation Deviations During Delivery of High-Fidelity Simulations.

PubMed

McIvor, William R; Banerjee, Arna; Boulet, John R; Bekhuis, Tanja; Tseytlin, Eugene; Torsher, Laurence; DeMaria, Samuel; Rask, John P; Shotwell, Matthew S; Burden, Amanda; Cooper, Jeffrey B; Gaba, David M; Levine, Adam; Park, Christine; Sinz, Elizabeth; Steadman, Randolph H; Weinger, Matthew B

2017-02-01

We developed a taxonomy of simulation delivery and documentation deviations noted during a multicenter, high-fidelity simulation trial that was conducted to assess practicing physicians' performance. Eight simulation centers sought to implement standardized scenarios over 2 years. Rules, guidelines, and detailed scenario scripts were established to facilitate reproducible scenario delivery; however, pilot trials revealed deviations from those rubrics. A taxonomy with hierarchically arranged terms that define a lack of standardization of simulation scenario delivery was then created to aid educators and researchers in assessing and describing their ability to reproducibly conduct simulations. Thirty-six types of delivery or documentation deviations were identified from the scenario scripts and study rules. Using a Delphi technique and open card sorting, simulation experts formulated a taxonomy of high-fidelity simulation execution and documentation deviations. The taxonomy was iteratively refined and then tested by 2 investigators not involved with its development. The taxonomy has 2 main classes, simulation center deviation and participant deviation, which are further subdivided into as many as 6 subclasses. Inter-rater classification agreement using the taxonomy was 74% or greater for each of the 7 levels of its hierarchy. Cohen kappa calculations confirmed substantial agreement beyond that expected by chance. All deviations were classified within the taxonomy. This is a useful taxonomy that standardizes terms for simulation delivery and documentation deviations, facilitates quality assurance in scenario delivery, and enables quantification of the impact of deviations upon simulation-based performance assessment.

Accounting for body size deviations when reporting bone mineral density variables in children.

PubMed

Webber, C E; Sala, A; Barr, R D

2009-01-01

In a child, bone mineral density (BMD) may differ from an age-expected normal value, not only because of the presence of disease, but also because of deviations of height or weight from population averages. Appropriate adjustment for body size deviations simplifies interpretation of BMD measurements. For children, a bone mineral density (BMD) measurement is normally expressed as a Z score. Interpretation is complicated when weight or height distinctly differ from age-matched children. We develop a procedure to allow for the influence of body size deviations upon measured BMD. We examined the relation between body size deviation and spine, hip and whole body BMD deviation in 179 normal children (91 girls). Expressions were developed that allowed derivation of an expected BMD based on age, gender and body size deviation. The difference between measured and expected BMD was expressed as a HAW score (Height-, Age-, Weight-adjusted score). In a second independent sample of 26 normal children (14 girls), measured spine, total femur and whole body BMD all fell within the same single normal range after accounting for age, gender and body size deviations. When traditional Z scores and HAW scores were compared in 154 children, 17.5% showed differences of more than 1 unit and such differences were associated with height and weight deviations. For almost 1 in 5 children, body size deviations influence BMD to an extent that could alter clinical management.

Metabolic engineering of microorganisms for biofuels production: from bugs to synthetic biology to fuels

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

Kuk Lee, Sung; Chou, Howard; Ham, Timothy S.

2009-12-02

The ability to generate microorganisms that can produce biofuels similar to petroleum-based transportation fuels would allow the use of existing engines and infrastructure and would save an enormous amount of capital required for replacing the current infrastructure to accommodate biofuels that have properties significantly different from petroleum-based fuels. Several groups have demonstrated the feasibility of manipulating microbes to produce molecules similar to petroleum-derived products, albeit at relatively low productivity (e.g. maximum butanol production is around 20 g/L). For cost-effective production of biofuels, the fuel-producing hosts and pathways must be engineered and optimized. Advances in metabolic engineering and synthetic biology willmore » provide new tools for metabolic engineers to better understand how to rewire the cell in order to create the desired phenotypes for the production of economically viable biofuels.« less

Modern mass spectrometry for synthetic biology and structure-based discovery of natural products.

PubMed

Henke, Matthew T; Kelleher, Neil L

2016-08-27

Covering: up to 2016In this highlight, we describe the current landscape for dereplication and discovery of natural products based on the measurement of the intact mass by LC-MS. Often it is assumed that because better mass accuracy (provided by higher resolution mass spectrometers) is necessary for absolute chemical formula determination (≤1 part-per-million), that it is also necessary for dereplication of natural products. However, the average ability to dereplicate tapers off at ∼10 ppm, with modest improvement gained from better mass accuracy when querying focused databases of natural products. We also highlight some recent examples of how these platforms are applied to synthetic biology, and recent methods for dereplication and correlation of substructures using tandem MS data. We also offer this highlight to serve as a brief primer for those entering the field of mass spectrometry-based natural products discovery.

Need for new technologies for detection of adventitious agents in vaccines and other biological products.

PubMed

Mallet, Laurent; Gisonni-Lex, Lucy

2014-01-01

From an industrial perspective, the conventional in vitro and in vivo assays used for detection of viral contaminants have shown their limitations, as illustrated by the unfortunate detection of porcine circovirus contamination in a licensed rotavirus vaccine. This contamination event illustrates the gaps within the existing adventitious agent strategy and the potential use of new broader molecular detection methods. This paper serves to summarize current testing approaches and challenges, along with opportunities for the use of these new technologies. Testing of biological products is required to ensure the safety of patients. Recently, a licensed vaccine was found to be contaminated with a virus. This contamination did not cause a safety concern to the patients; however, it highlights the need for using new testing methods to control our biological products. This paper introduces the benefits of these new tests and outlines the challenges with the current tests. © PDA, Inc. 2014.

Production Biology of Phytoplankton

DTIC Science & Technology

1999-09-30

the publishing house, Universities Press (India) in Hyderabad ( Deccan ). New title: Breeding, Growth Rates, and Production of Marine Copepods. The...into sediment traps at 3 km depth indicate an onset of high primary production very soon after the arrival of the SWM and suggest a long open-sea...into the traps is disconcerting. For future modeling of plankton production in the open Arabian Sea, the use of two size classes of phytoplankton is

ASTM lights the way for tissue engineered medical products standards: jump start for combination medical products that restore biological function of human tissues.

PubMed

Picciolo, G L; Stocum, D L

2001-01-01

Everybody hopes for better health and restoration of impaired bodily function, and now that hope is illuminated by the promise of powerful biological tools that make human cells grow and replace human tissue. ASTM Committee F04 on Medical and Surgical Materials and Devices is taking the lead by defining some of those tools as standards that can be used for the development, production, testing, and regulatory approval of medical products.

Gait deviations in Duchenne muscular dystrophy-Part 2. Statistical non-parametric mapping to analyze gait deviations in children with Duchenne muscular dystrophy.

PubMed

Goudriaan, Marije; Van den Hauwe, Marleen; Simon-Martinez, Cristina; Huenaerts, Catherine; Molenaers, Guy; Goemans, Nathalie; Desloovere, Kaat

2018-04-30

Prolonged ambulation is considered important in children with Duchenne muscular dystrophy (DMD). However, previous studies analyzing DMD gait were sensitive to false positive outcomes, caused by uncorrected multiple comparisons, regional focus bias, and inter-component covariance bias. Also, while muscle weakness is often suggested to be the main cause for the altered gait pattern in DMD, this was never verified. Our research question was twofold: 1) are we able to confirm the sagittal kinematic and kinetic gait alterations described in a previous review with statistical non-parametric mapping (SnPM)? And 2) are these gait deviations related to lower limb weakness? We compared gait kinematics and kinetics of 15 children with DMD and 15 typical developing (TD) children (5-17 years), with a two sample Hotelling's T 2 test and post-hoc two-tailed, two-sample t-test. We used canonical correlation analyses to study the relationship between weakness and altered gait parameters. For all analyses, α-level was corrected for multiple comparisons, resulting in α = 0.005. We only found one of the previously reported kinematic deviations: the children with DMD had an increased knee flexion angle during swing (p = 0.0006). Observed gait deviations that were not reported in the review were an increased hip flexion angle during stance (p = 0.0009) and swing (p = 0.0001), altered combined knee and ankle torques (p = 0.0002), and decreased power absorption during stance (p = 0.0001). No relationships between weakness and these gait deviations were found. We were not able to replicate the gait deviations in DMD previously reported in literature, thus DMD gait remains undefined. Further, weakness does not seem to be linearly related to altered gait features. The progressive nature of the disease requires larger study populations and longitudinal analyses to gain more insight into DMD gait and its underlying causes. Copyright © 2018 Elsevier B.V. All rights

Biological conversion system

DOEpatents

Scott, C.D.

A system for bioconversion of organic material comprises a primary bioreactor column wherein a biological active agent (zymomonas mobilis) converts the organic material (sugar) to a product (alcohol), a rejuvenator column wherein the biological activity of said biological active agent is enhanced, and means for circulating said biological active agent between said primary bioreactor column and said rejuvenator column.

Genome-scale biological models for industrial microbial systems.

PubMed

Xu, Nan; Ye, Chao; Liu, Liming

2018-04-01

The primary aims and challenges associated with microbial fermentation include achieving faster cell growth, higher productivity, and more robust production processes. Genome-scale biological models, predicting the formation of an interaction among genetic materials, enzymes, and metabolites, constitute a systematic and comprehensive platform to analyze and optimize the microbial growth and production of biological products. Genome-scale biological models can help optimize microbial growth-associated traits by simulating biomass formation, predicting growth rates, and identifying the requirements for cell growth. With regard to microbial product biosynthesis, genome-scale biological models can be used to design product biosynthetic pathways, accelerate production efficiency, and reduce metabolic side effects, leading to improved production performance. The present review discusses the development of microbial genome-scale biological models since their emergence and emphasizes their pertinent application in improving industrial microbial fermentation of biological products.

Biological Oceanography

NASA Technical Reports Server (NTRS)

Abbott, M. R.

1984-01-01

Within the framework of global biogeochemical cycles and ocean productivity, there are two areas that will be of particular interest to biological oceanography in the 1990s. The first is the mapping in space time of the biomass and productivity of phytoplankton in the world ocean. The second area is the coupling of biological and physical processes as it affects the distribution and growth rate of phytoplankton biomass. Certainly other areas will be of interest to biological oceanographers, but these two areas are amenable to observations from satellites. Temporal and spatial variability is a regular feature of marine ecosystems. The temporal and spatial variability of phytoplankton biomass and productivity which is ubiquitous at all time and space scales in the ocean must be characterized. Remote sensing from satellites addresses these problems with global observations of mesocale (2 to 20 days, 10 to 200 km) features over a long period of time.

A Correlational Study of Scoliosis and Trunk Balance in Adult Patients with Mandibular Deviation

PubMed Central

Yang, Yang; Wang, Na; Wang, Wenyong; Ding, Yin; Sun, Shiyao

2013-01-01

Previous studies have confirmed that patients with mandibular deviation often have abnormal morphology of their cervical vertebrae. However, the relationship between mandibular deviation, scoliosis, and trunk balance has not been studied. Currently, mandibular deviation is usually treated as a single pathology, which leads to poor clinical efficiency. We investigated the relationship of spine coronal morphology and trunk balance in adult patients with mandibular deviation, and compared the finding to those in healthy volunteers. 35 adult patients with skeletal mandibular deviation and 10 healthy volunteers underwent anterior X-ray films of the head and posteroanterior X-ray films of the spine. Landmarks and lines were drawn and measured on these films. The axis distance method was used to measure the degree of scoliosis and the balance angle method was used to measure trunk balance. The relationship of mandibular deviation, spine coronal morphology and trunk balance was evaluated with the Pearson correlation method. The spine coronal morphology of patients with mandibular deviation demonstrated an “S” type curve, while a straight line parallel with the gravity line was found in the control group (significant difference, p<0.01). The trunk balance of patients with mandibular deviation was disturbed (imbalance angle >1°), while the control group had a normal trunk balance (imbalance angle <1°). There was a significant difference between the two groups (p<0.01). The degree of scoliosis and shoulder imbalance correlated with the degree of mandibular deviation, and presented a linear trend. The direction of mandibular deviation was the same as that of the lateral bending of thoracolumbar vertebrae, which was opposite to the direction of lateral bending of cervical vertebrae. Our study shows the degree of mandibular deviation has a high correlation with the degree of scoliosis and trunk imbalance, all the three deformities should be clinically evaluated in the

Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Final rule.

PubMed

2014-12-04

The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the "Pregnancy," "Labor and delivery," and "Nursing mothers" subsections of the "Use in Specific Populations" section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the "Labor and delivery" subsection because information about labor and delivery is included in the "Pregnancy" subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.

48 CFR 927.403 - Negotiations and deviations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Negotiations and deviations. 927.403 Section 927.403 Federal Acquisition Regulations System DEPARTMENT OF ENERGY GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Technical Data and Copyrights 927.403 Negotiations and...

48 CFR 927.403 - Negotiations and deviations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Negotiations and deviations. 927.403 Section 927.403 Federal Acquisition Regulations System DEPARTMENT OF ENERGY GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Technical Data and Copyrights 927.403 Negotiations and...

48 CFR 927.403 - Negotiations and deviations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 5 2012-10-01 2012-10-01 false Negotiations and deviations. 927.403 Section 927.403 Federal Acquisition Regulations System DEPARTMENT OF ENERGY GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Technical Data and Copyrights 927.403 Negotiations and...

48 CFR 927.403 - Negotiations and deviations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Negotiations and deviations. 927.403 Section 927.403 Federal Acquisition Regulations System DEPARTMENT OF ENERGY GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Technical Data and Copyrights 927.403 Negotiations and...

48 CFR 927.403 - Negotiations and deviations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Negotiations and deviations. 927.403 Section 927.403 Federal Acquisition Regulations System DEPARTMENT OF ENERGY GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Technical Data and Copyrights 927.403 Negotiations and...

Biological Targets and Mechanisms of Action of Natural Products from Marine Cyanobacteria

PubMed Central

Salvador-Reyes, Lilibeth A.

2015-01-01

Marine cyanobacteria are an ancient group of organisms and prolific producers of bioactive secondary metabolites. These compounds are presumably optimized by evolution over billions of years to exert high affinity for their intended biological target in the ecologically relevant organism but likely also possess activity in different biological contexts such as human cells. Screening of marine cyanobacterial extracts for bioactive natural products has largely focused on cancer cell viability; however, diversification of the screening platform led to the characterization of many new bioactive compounds. Targets of compounds have oftentimes been elusive if the compounds were discovered through phenotypic assays. Over the past few years, technology has advanced to determine mechanism of action (MOA) and targets through reverse chemical genetic and proteomic approaches, which has been applied to certain cyanobacterial compounds and will be discussed in this review. Some cyanobacterial molecules are the most-potent-in-class inhibitors and therefore may become valuable tools for chemical biology to probe protein function but also be templates for novel drugs, assuming in vitro potency translates into cellular and in vivo activity. Our review will focus on compounds for which the direct targets have been deciphered or which were found to target a novel pathway, and link them to disease states where target modulation may be beneficial. PMID:25571978

Scaling Deviations for Neutrino Reactions in Aysmptotically Free Field Theories

DOE R&D Accomplishments Database

Wilczek, F. A.; Zee, A.; Treiman, S. B.

1974-11-01

Several aspects of deep inelastic neutrino scattering are discussed in the framework of asymptotically free field theories. We first consider the growth behavior of the total cross sections at large energies. Because of the deviations from strict scaling which are characteristic of such theories the growth need not be linear. However, upper and lower bounds are established which rather closely bracket a linear growth. We next consider in more detail the expected pattern of scaling deviation for the structure functions and, correspondingly, for the differential cross sections. The analysis here is based on certain speculative assumptions. The focus is on qualitative effects of scaling breakdown as they may show up in the X and y distributions. The last section of the paper deals with deviations from the Callan-Gross relation.

Does standard deviation matter? Using "standard deviation" to quantify security of multistage testing.

PubMed

Wang, Chun; Zheng, Yi; Chang, Hua-Hua

2014-01-01

With the advent of web-based technology, online testing is becoming a mainstream mode in large-scale educational assessments. Most online tests are administered continuously in a testing window, which may post test security problems because examinees who take the test earlier may share information with those who take the test later. Researchers have proposed various statistical indices to assess the test security, and one most often used index is the average test-overlap rate, which was further generalized to the item pooling index (Chang & Zhang, 2002, 2003). These indices, however, are all defined as the means (that is, the expected proportion of common items among examinees) and they were originally proposed for computerized adaptive testing (CAT). Recently, multistage testing (MST) has become a popular alternative to CAT. The unique features of MST make it important to report not only the mean, but also the standard deviation (SD) of test overlap rate, as we advocate in this paper. The standard deviation of test overlap rate adds important information to the test security profile, because for the same mean, a large SD reflects that certain groups of examinees share more common items than other groups. In this study, we analytically derived the lower bounds of the SD under MST, with the results under CAT as a benchmark. It is shown that when the mean overlap rate is the same between MST and CAT, the SD of test overlap tends to be larger in MST. A simulation study was conducted to provide empirical evidence. We also compared the security of MST under the single-pool versus the multiple-pool designs; both analytical and simulation studies show that the non-overlapping multiple-pool design will slightly increase the security risk.

Precision analysis for standard deviation measurements of immobile single fluorescent molecule images.

PubMed

DeSantis, Michael C; DeCenzo, Shawn H; Li, Je-Luen; Wang, Y M

2010-03-29

Standard deviation measurements of intensity profiles of stationary single fluorescent molecules are useful for studying axial localization, molecular orientation, and a fluorescence imaging system's spatial resolution. Here we report on the analysis of the precision of standard deviation measurements of intensity profiles of single fluorescent molecules imaged using an EMCCD camera.We have developed an analytical expression for the standard deviation measurement error of a single image which is a function of the total number of detected photons, the background photon noise, and the camera pixel size. The theoretical results agree well with the experimental, simulation, and numerical integration results. Using this expression, we show that single-molecule standard deviation measurements offer nanometer precision for a large range of experimental parameters.

Biology Notes.

ERIC Educational Resources Information Center

School Science Review, 1982

1982-01-01

Presents procedures, exercises, demonstrations, and information on a variety of biology topics including labeling systems, biological indicators of stream pollution, growth of lichens, reproductive capacity of bulbous buttercups, a straw balance to measure transpiration, interaction of fungi, osmosis, and nitrogen fixation and crop production. (DC)

Secondary flow spanwise deviation model for the stators of NASA middle compressor stages

NASA Technical Reports Server (NTRS)

Roberts, W. B.; Sandercock, D. M.

1984-01-01

A model of the spanwise variation of deviation for stator blades is presented. Deviation is defined as the difference between the passage mean flow angle and the metal angle at the outlet of a blade element of an axial compressor stage. The variation of deviation is taken as the difference above or below that predicted by blade element, (i.e., two-dimensional) theory at any spanwise location. The variation of deviation is dependent upon the blade camber, solidity and inlet boundary layer thickness at the hub or tip end-wall, and the blade channel aspect ratio. If these parameters are known or can be calculated, the model provides a reasonable approximation of the spanwise variation of deviation for most compressor middle stage stators operating at subsonic inlet Mach numbers.

76 FR 79203 - Prospective Grant of Exclusive License: Veterinary Biological Products for Swine Influenza Vaccines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

... Exclusive License: Veterinary Biological Products for Swine Influenza Vaccines AGENCY: National Institutes....7. The invention relates to compositions and methods of use as Veterinary Influenza Vaccines... to humans. This technology describes DNA vaccines against influenza serotypes H5N1, H1N1, H3N2, and...

Linear maps preserving maximal deviation and the Jordan structure of quantum systems

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

Hamhalter, Jan

2012-12-15

In the algebraic approach to quantum theory, a quantum observable is given by an element of a Jordan algebra and a state of the system is modelled by a normalized positive functional on the underlying algebra. Maximal deviation of a quantum observable is the largest statistical deviation one can obtain in a particular state of the system. The main result of the paper shows that each linear bijective transformation between JBW algebras preserving maximal deviations is formed by a Jordan isomorphism or a minus Jordan isomorphism perturbed by a linear functional multiple of an identity. It shows that only onemore » numerical statistical characteristic has the power to determine the Jordan algebraic structure completely. As a consequence, we obtain that only very special maps can preserve the diameter of the spectra of elements. Nonlinear maps preserving the pseudometric given by maximal deviation are also described. The results generalize hitherto known theorems on preservers of maximal deviation in the case of self-adjoint parts of von Neumann algebras proved by Molnar.« less

Analysis of using the tongue deviation angle as a warning sign of a stroke

PubMed Central

2012-01-01

Background The symptom of tongue deviation is observed in a stroke or transient ischemic attack. Nevertheless, there is much room for the interpretation of the tongue deviation test. The crucial factor is the lack of an effective quantification method of tongue deviation. If we can quantify the features of the tongue deviation and scientifically verify the relationship between the deviation angle and a stroke, the information provided by the tongue will be helpful in recognizing a warning of a stroke. Methods In this study, a quantification method of the tongue deviation angle was proposed for the first time to characterize stroke patients. We captured the tongue images of stroke patients (15 males and 10 females, ranging between 55 and 82 years of age); transient ischemic attack (TIA) patients (16 males and 9 females, ranging between 53 and 79 years of age); and normal subjects (14 males and 11 females, ranging between 52 and 80 years of age) to analyze whether the method is effective. In addition, we used the receiver operating characteristic curve (ROC) for the sensitivity analysis, and determined the threshold value of the tongue deviation angle for the warning sign of a stroke. Results The means and standard deviations of the tongue deviation angles of the stroke, TIA, and normal groups were: 6.9 ± 3.1, 4.9 ± 2.1 and 1.4 ± 0.8 degrees, respectively. Analyzed by the unpaired Student’s t-test, the p-value between the stroke group and the TIA group was 0.015 (>0.01), indicating no significant difference in the tongue deviation angle. The p-values between the stroke group and the normal group, as well as between the TIA group and the normal group were both less than 0.01. These results show the significant differences in the tongue deviation angle between the patient groups (stroke and TIA patients) and the normal group. These results also imply that the tongue deviation angle can effectively identify the patient group (stroke and TIA patients

Analysis of using the tongue deviation angle as a warning sign of a stroke.

PubMed

Wei, Ching-Chuan; Huang, Shu-Wen; Hsu, Sheng-Lin; Chen, Hsing-Chung; Chen, Jong-Shin; Liang, Hsinying

2012-08-21

The symptom of tongue deviation is observed in a stroke or transient ischemic attack. Nevertheless, there is much room for the interpretation of the tongue deviation test. The crucial factor is the lack of an effective quantification method of tongue deviation. If we can quantify the features of the tongue deviation and scientifically verify the relationship between the deviation angle and a stroke, the information provided by the tongue will be helpful in recognizing a warning of a stroke. In this study, a quantification method of the tongue deviation angle was proposed for the first time to characterize stroke patients. We captured the tongue images of stroke patients (15 males and 10 females, ranging between 55 and 82 years of age); transient ischemic attack (TIA) patients (16 males and 9 females, ranging between 53 and 79 years of age); and normal subjects (14 males and 11 females, ranging between 52 and 80 years of age) to analyze whether the method is effective. In addition, we used the receiver operating characteristic curve (ROC) for the sensitivity analysis, and determined the threshold value of the tongue deviation angle for the warning sign of a stroke. The means and standard deviations of the tongue deviation angles of the stroke, TIA, and normal groups were: 6.9 ± 3.1, 4.9 ± 2.1 and 1.4 ± 0.8 degrees, respectively. Analyzed by the unpaired Student's t-test, the p-value between the stroke group and the TIA group was 0.015 (>0.01), indicating no significant difference in the tongue deviation angle. The p-values between the stroke group and the normal group, as well as between the TIA group and the normal group were both less than 0.01. These results show the significant differences in the tongue deviation angle between the patient groups (stroke and TIA patients) and the normal group. These results also imply that the tongue deviation angle can effectively identify the patient group (stroke and TIA patients) and the normal group. With

Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products. Final rule.

PubMed

2015-07-08

The Food and Drug Administration (FDA or the Agency) is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products--including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application--to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.

Deviations from LTE in a stellar atmosphere

NASA Technical Reports Server (NTRS)

Kalkofen, W.; Klein, R. I.; Stein, R. F.

1979-01-01

Deviations for LTE are investigated in an atmosphere of hydrogen atoms with one bound level, satisfying the equations of radiative, hydrostatic, and statistical equilibrium. The departure coefficient and the kinetic temperature as functions of the frequency dependence of the radiative cross section are studied analytically and numerically. Near the outer boundary of the atmosphere, the departure coefficient is smaller than unity when the radiative cross section grows with frequency faster than with the square of frequency; it exceeds unity otherwise. Far from the boundary the departure coefficient tends to exceed unity for any frequency dependence of the radiative cross section. Overpopulation always implies that the kinetic temperature in the statistical-equilibrium atmosphere is higher than the temperature in the corresponding LTE atmosphere. Upper and lower bounds on the kinetic temperature are given for an atmosphere with deviations from LTE only in the optically shallow layers when the emergent intensity can be described by a radiation temperature.

A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs)

PubMed Central

Jones, David R; McBlane, James W; McNaughton, Graham; Rajakumaraswamy, Nishanthan; Wydenbach, Kirsty

2013-01-01

The safety of trial subjects is the tenet that guides the regulatory assessment of a Clinical Trial Authorization application and applies equally to trials involving small molecules and those with biological/biotechnological products, including Advanced Therapy Medicinal Products. The objective of a regulator is to ensure that the potential risk faced by a trial subject is outweighed by the potential benefit to them from taking part in the trial. The focus of the application review is to assess whether risks have been identified and appropriate steps taken to alleviate these as much as possible. Other factors are also taken into account during a review, such as regulatory requirements, and emerging non-clinical and clinical data from other trials on the same or similar products. This paper examines the regulatory review process of a Clinical Trial Authorization application from the perspectives of Quality, Non-Clinical and Clinical Regulatory Assessors at the Medicines and Healthcare products Regulatory Agency. It should be noted that each perspective has highlighted specific issues from their individual competence and that these can be different between the disciplines. PMID:23216470