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Sample records for biopharmaceutics classification system

  1. The role of BCS (biopharmaceutics classification system) and BDDCS (biopharmaceutics drug disposition classification system) in drug development.

    Science.gov (United States)

    Benet, Leslie Z

    2013-01-01

    Biopharmaceutics Classification System and Biopharmaceutics Drug Distribution Classification System are complimentary, not competing, classification systems that aim to improve, simplify, and speed drug development. Although both systems are based on classifying drugs and new molecular entities into four categories using the same solubility criteria, they differ in the criterion for permeability and have different purposes. Here, the details and applications of both systems are reviewed with particular emphasis of their role in drug development. Copyright © 2012 Wiley Periodicals, Inc.

  2. Paediatric biopharmaceutics classification system: current status and future decisions.

    Science.gov (United States)

    Batchelor, Hannah

    2014-08-05

    Biopharmaceutical methods are routinely used in the design of medicines to predict in vivo absorption and hence guide the development of new products. Differences in anatomy and physiology of paediatric patients require adaptation of existing biopharmaceutical methods to ensure that in vivo predictions are relevant for this population. The biopharmaceutics classification system is a tool used in drug development to guide formulation selection and manufacture from early clinical studies through to product launch. The applicability of the biopharmaceutics system to paediatric product development has yet to be explored; this note brings together some key issues in direct extrapolation from adults into paediatric populations. Copyright © 2014. Published by Elsevier B.V.

  3. Interplay of biopharmaceutics, biopharmaceutics drug disposition and salivary excretion classification systems.

    Science.gov (United States)

    Idkaidek, Nasir M

    2014-01-01

    The aim of this commentary is to investigate the interplay of Biopharmaceutics Classification System (BCS), Biopharmaceutics Drug Disposition Classification System (BDDCS) and Salivary Excretion Classification System (SECS). BCS first classified drugs based on permeability and solubility for the purpose of predicting oral drug absorption. Then BDDCS linked permeability with hepatic metabolism and classified drugs based on metabolism and solubility for the purpose of predicting oral drug disposition. On the other hand, SECS classified drugs based on permeability and protein binding for the purpose of predicting the salivary excretion of drugs. The role of metabolism, rather than permeability, on salivary excretion is investigated and the results are not in agreement with BDDCS. The proposed Salivary Excretion Classification System (SECS) can be used as a guide for drug salivary excretion based on permeability (not metabolism) and protein binding.

  4. [Construction of biopharmaceutics classification system of Chinese materia medica].

    Science.gov (United States)

    Liu, Yang; Wei, Li; Dong, Ling; Zhu, Mei-Ling; Tang, Ming-Min; Zhang, Lei

    2014-12-01

    Based on the characteristics of multicomponent of traditional Chinese medicine and drawing lessons from the concepts, methods and techniques of biopharmaceutics classification system (BCS) in chemical field, this study comes up with the science framework of biopharmaceutics classification system of Chinese materia medica (CMMBCS). Using the different comparison method of multicomponent level and the CMMBCS method of overall traditional Chinese medicine, the study constructs the method process while setting forth academic thoughts and analyzing theory. The basic role of this system is clear to reveal the interaction and the related absorption mechanism of multicomponent in traditional Chinese medicine. It also provides new ideas and methods for improving the quality of Chinese materia medica and the development of new drug research.

  5. Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond.

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    Polli, James E; Abrahamsson, Bertil S I; Yu, Lawrence X; Amidon, Gordon L; Baldoni, John M; Cook, Jack A; Fackler, Paul; Hartauer, Kerry; Johnston, Gordon; Krill, Steve L; Lipper, Robert A; Malick, Waseem A; Shah, Vinod P; Sun, Duxin; Winkle, Helen N; Wu, Yunhui; Zhang, Hua

    2008-06-01

    The workshop "Bioequivalence, Biopharmaceutics Classification System, and Beyond" was held May 21-23, 2007 in North Bethesda, MD, USA. This workshop provided an opportunity for pharmaceutical scientists to discuss the FDA guidance on the Biopharmaceutics Classification System (BCS), bioequivalence of oral products, and related FDA initiatives such as the FDA Critical Path Initiative. The objective of this Summary Workshop Report is to document the main points from this workshop. Key highlights of the workshop were (a) the described granting of over a dozen BCS-based biowaivers by the FDA for Class I drugs whose formulations exhibit rapid dissolution, (b) continued scientific support for biowaivers for Class III compounds whose formulations exhibit very rapid dissolution, (c) scientific support for a number of permeability methodologies to assess BCS permeability class, (d) utilization of BCS in pharmaceutical research and development, and (e) scientific progress in in vitro dissolution methods to predict dosage form performance.

  6. The utility of rat jejunal permeability for biopharmaceutics classification system.

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    Zakeri-Milani, Parvin; Valizadeh, Hadi; Tajerzadeh, Hosnieh; Islambulchilar, Ziba

    2009-12-01

    The biopharmaceutical classification system has been developed to provide a scientific approach for classifying drug compounds based on their dose/solubility ratio and human intestinal permeability. Therefore in this study a new classification is presented, which is based on a correlation between rat and human intestinal permeability values. In situ technique in rat jejunum was used to determine the effective intestinal permeability of tested drugs. Then three dimensionless parameters--dose number, absorption number, and dissolution number (D(o), A(n), and D(n))--were calculated for each drug. Four classes of drugs were defined, that is, class I, D(0) 5.09 x 10(-5) cm/s; class II, D(o) > 1, P(eff(rat)) > 5.09 x 10( -5) cm/s; class III, D(0) 1, P(eff(rat)) < 4.2 x 10(-5) cm/s. A region of borderline drugs (0.5 < D(o) < 1, 4.2 x 10(-5) < P(eff(rat)) < 5.09 x 10(-5) cm/s) was also defined. According to obtained results and proposed classification for drugs, it is concluded that drugs could be categorized correctly based on dose number and their intestinal permeability values in rat model using single-pass intestinal perfusion technique. This classification enables us to remark defined characteristics for intestinal absorption of all four classes using suitable cutoff points for both dose number and rat effective intestinal permeability values.

  7. Impact of Biopharmaceutics Classification System-based biowaivers.

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    Cook, Jack A; Davit, Barbara M; Polli, James E

    2010-10-04

    The Biopharmaceutics Classification System (BCS) is employed to waive in vivo bioequivalence testing (i.e. provide "biowaivers") for new and generic drugs that are BCS class I. Granting biowaivers under systems such as the BCS eliminates unnecessary drug exposures to healthy subjects and provides economic relief, while maintaining the high public health standard for therapeutic equivalence. International scientific consensus suggests class III drugs are also eligible for biowaivers. The objective of this study was to estimate the economic impact of class I BCS-based biowaivers, along with the economic impact of a potential expansion to BCS class III. Methods consider the distribution of drugs across the four BCS classes, numbers of in vivo bioequivalence studies performed from a five year period, and effects of highly variable drugs (HVDs). Results indicate that 26% of all drugs are class I non-HVDs, 7% are class I HVDs, 27% are class III non-HVDs, and 3% are class III HVDs. An estimated 66 to 76 million dollars can be saved each year in clinical study costs if all class I compounds were granted biowaivers. Between 21 and 24 million dollars of this savings is from HVDs. If BCS class III compounds were also granted waivers, an additional direct savings of 62 to 71 million dollars would be realized, with 9 to 10 million dollars coming from HVDs.

  8. Biopharmaceutics classification system: importance and inclusion in biowaiver guidance

    Directory of Open Access Journals (Sweden)

    Lorena Barbosa Arrunátegui

    2015-03-01

    Full Text Available Pharmacological therapy is essential in many diseases treatment and it is important that the medicine policy is intended to offering safe and effective treatment with affordable price to the population. One way to achieve this is through biowaiver, defined as the replacement of in vivo bioequivalence studies by in vitro studies. For biowaiver of new immediate release solid oral dosage forms, data such as intestinal permeability and solubility of the drug are required, as well as the product dissolution. The Biopharmaceutics Classification System (BCS is a scientific scheme that divides drugs according to their solubility and permeability and has been used by various guides as a criterion for biowaiver. This paper evaluates biowaiver application, addressing the general concepts and parameters used by BCS, making a historical account of its use, the requirements pertaining to the current legislation, the benefits and risks associated with this decision. The results revealed that the use of BCS as a biowaiver criterion greatly expands the therapeutics options, contributing to greater therapy access of the general population with drug efficacy and safety guaranteed associated to low cost.

  9. Caco-2 cells, biopharmaceutics classification system (BCS) and biowaiver.

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    Smetanová, Libuse; Stĕtinová, Vĕra; Svoboda, Zbynek; Kvetina, Jaroslav

    2011-01-01

    Almost all orally administered drugs are absorbed across the intestinal mucosa. The Caco-2 monolayers are used as an in vitro model to predict drug absorption in humans and to explore mechanism of drug absorption. The Caco-2 cells are derived from a human colon adenocarcinoma and spontaneously differentiate to form confluent monolayer of polarized cells structurally and functionally resembling the small intestinal epithelium. For studying drug permeability, Caco-2 cells are seeded onto the Transwell inserts with semipermeable membrane and grown to late confluence (21 days). After determination of cell viability, the integrity of monolayer is checked by phenol red permeability and by 14C-mannitol permeability. The transport from apical to basolateral (AP-BL) and basolateral to apical (BL-AP) is studied by adding the diluted drug on the apical or basolateral side and withdrawing the samples from the opposite compartment, respectively, for HPLC analysis or liquid scintillation spectrometry. Ca2+ -free transport medium is used to determine paracellular component of the drug transport. On the basis of permeability and solubility, drugs can be categorized into four classes of Biopharmaceutics Classification System (BCS). For certain drugs, the BCS-based biowaiver approach can be used which enables to reduce in vivo bioequivalence studies.

  10. Is the full potential of the biopharmaceutics classification system reached?

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    Bergström, Christel A S; Andersson, Sara B E; Fagerberg, Jonas H; Ragnarsson, Gert; Lindahl, Anders

    2014-06-16

    In this paper we analyse how the biopharmaceutics classification system (BCS) has been used to date. A survey of the literature resulted in a compilation of 242 compounds for which BCS classes were reported. Of these, 183 compounds had been reported to belong to one specific BCS class whereas 59 compounds had been assigned to multiple BCS classes in different papers. Interestingly, a majority of the BCS class 2 compounds had fraction absorbed (FA) values >85%, indicating that they were completely absorbed after oral administration. Solubility was computationally predicted at pH 6.8 for BCS class 2 compounds to explore the impact of the pH of the small intestine, where most of the absorption occurs, on the solubility. In addition, the solubilization capacity of lipid aggregates naturally present in the intestine was studied computationally and experimentally for a subset of 12 compounds. It was found that all acidic compounds with FA>85% were completely dissolved in the pH of the small intestine. Further, lipids at the concentration used in fasted state simulated intestinal fluid (FaSSIF) dissolved the complete dose given of the most lipophilic (logD6.5>3) compounds studied. Overall, biorelevant dissolution media (pure buffer of intestinal pH or FaSSIF) identified that for 20 of the 29 BCS class 2 compounds with FA>85% the complete dose given orally would be dissolved. These results indicate that a more relevant pH restriction for acids and/or dissolution medium with lipids present better forecast solubility-limited absorption in vivo than the presently used BCS solubility criterion. The analysis presented herein further strengthens the discussion on the requirement of more physiologically relevant dissolution media for the in vitro solubility classification performed to reach the full potential of the BCS. Copyright © 2013 Elsevier B.V. All rights reserved.

  11. Evaluation and suggested improvements of the Biopharmaceutics Classification System (BCS).

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    Fagerholm, Urban

    2007-06-01

    This review has evaluated the Biopharmaceutics Classification System (BCS) and improvements have been proposed. The BCS has a very strict solubility/dissolution limit, a generous P(e)-limit (> or = 14-times higher rate constant limit for dissolution than for permeation), and is stricter for drugs with a long half-life (t(1/2)). Available human in-vivo, in-vitro, and in-silico P(e)-methods cannot classify P(e) for moderately to highly permeable substances sufficiently well, and in-vitro data often underpredict the in-vivo dissolution potential and rate. Good in-vivo dissolution and absorption can be expected for most high P(e) drug products. It has not been possible to find a highly permeable product with a Dose number (D(o)) 40 and > 95% dissolved within 30 min and 3 h, respectively); the limit for high P(e) is increased (to >P(e) of metoprolol); accurate P(e)-models or in-vivo fraction absorbed data are used; solubility/dissolution tests are performed using real or validated simulated gastrointestinal fluids; in-vitro/in-vivo dissolution relationships are established; the t(1/2) is considered; and the rate-limiting step for in-vivo absorption is determined. A major change could be to reduce the BCS into two classes: permeation-rate (Class I) or dissolution-rate (Class II) limited absorption. It is believed that this could give a better balance and increase the number of biowaivers.

  12. [Study on biopharmaceutics classification system for Chinese materia medica of extract of Huanglian].

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    Liu, Yang; Yin, Xiu-Wen; Wang, Zi-Yu; Li, Xue-Lian; Pan, Meng; Li, Yan-Ping; Dong, Ling

    2017-11-01

    One of the advantages of biopharmaceutics classification system of Chinese materia medica (CMMBCS) is expanding the classification research level from single ingredient to multi-components of Chinese herb, and from multi-components research to holistic research of the Chinese materia medica. In present paper, the alkaloids of extract of huanglian were chosen as the main research object to explore their change rules in solubility and intestinal permeability of single-component and multi-components, and to determine the biopharmaceutical classification of extract of Huanglian from holistic level. The typical shake-flask method and HPLC were used to detect the solubility of single ingredient of alkaloids from extract of huanglian. The quantitative research of alkaloids in intestinal absorption was measured in single-pass intestinal perfusion experiment while permeability coefficient of extract of huanglian was calculated by self-defined weight coefficient method. Copyright© by the Chinese Pharmaceutical Association.

  13. A comparative analysis of biopharmaceutics classification system and biopharmaceutics drug disposition classification system: a cross-sectional survey with 500 bioequivalence studies.

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    Cristofoletti, Rodrigo; Chiann, Chang; Dressman, Jennifer B; Storpirtis, Silvia

    2013-09-01

    Although policies of waiving bioequivalence studies are part of the legal framework of various regulatory agencies, there is no harmonization with regard to extension of the biowaiver to drugs other than those with high solubility and high permeability, nor is there any consensus or official endorsement of the biopharmaceutics drug disposition classification system (BDDCS). To better understand the applicability of the biowaiver, we carried out a cross-sectional survey to estimate the relative risk of obtaining nonbioequivalent (non-BE) or bioinequivalent (BIE) results for drug products containing drugs belonging to each of the biopharmaceutics classification system (BCS) and BDDCS classes. Five hundred bioequivalence studies were randomly sampled from a database of the Brazilian Health Surveillance Agency (ANVISA). The drugs were classified according to the BCS and BDDCS, to evaluate how characteristics related to drug and dosage form influence the outcome of bioequivalence studies. The relative risk of obtaining a non-BE result was approximately four times lower for drugs in classes 1 and 3 of BCS or BDDCS when compared with class 2 drugs. Thus, it seems that the final outcome of a bioequivalence study is strongly influenced by the solubility of the drug, but not by its intestinal permeability or extent of metabolism. Copyright © 2013 Wiley Periodicals, Inc.

  14. The developability classification system: application of biopharmaceutics concepts to formulation development.

    Science.gov (United States)

    Butler, James M; Dressman, Jennifer B

    2010-12-01

    A revised classification system for oral drugs was developed using the biopharmaceutics classification system (BCS) as a starting point. The revised system is designed to have a greater focus on drug developability. Intestinal solubility, the compensatory nature of solubility and permeability in the small intestine and an estimate of the particle size needed to overcome dissolution rate limited absorption were all considered in the revised system. The system was then validated by comparison with literature on the in vivo performance of a number of test compounds. Observations on the test compounds were consistent with the revised classification, termed the developability classification system (DCS), showing it to be of greater value in predicting what factors are critical to in vivo performance than the widely used BCS. © 2010 Wiley-Liss, Inc. and the American Pharmacists Association

  15. Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs.

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    Kortejärvi, H; Shawahna, R; Koski, A; Malkki, J; Ojala, K; Yliperttula, M

    2010-02-01

    Currently, the EMEA, FDA, and WHO as regulatory authorities accept rapidly dissolving (>85% dissolved in 30 min) biopharmaceutics classification system (BCS) I drug products for biowaiver candidates. In the draft EMEA guideline the requirement has been set tighter, that is, the drug product should be very rapidly dissolving (>85% dissolved in 15 min) to be eligible for a biowaiver. Pharmacokinetic modeling of 32 BCS I drugs was performed to demonstrate that very rapid dissolution is not necessary to guarantee bioequivalence for them. Rapid dissolution and similar dissolution profiles are sufficient criteria for all BCS I drugs. (c) 2009 Wiley-Liss, Inc. and the American Pharmacists Association.

  16. Forecasting oral absorption across biopharmaceutics classification system classes with physiologically based pharmacokinetic models.

    Science.gov (United States)

    Hansmann, Simone; Darwich, Adam; Margolskee, Alison; Aarons, Leon; Dressman, Jennifer

    2016-12-01

    The aim of this study was (1) to determine how closely physiologically based pharmacokinetic (PBPK) models can predict oral bioavailability using a priori knowledge of drug-specific properties and (2) to examine the influence of the biopharmaceutics classification system class on the simulation success. Simcyp Simulator, GastroPlus ™ and GI-Sim were used. Compounds with published Biowaiver monographs (bisoprolol (BCS I), nifedipine (BCS II), cimetidine (BCS III), furosemide (BCS IV)) were selected to ensure availability of accurate and reproducible data for all required parameters. Simulation success was evaluated with the average fold error (AFE) and absolute average fold error (AAFE). Parameter sensitivity analysis (PSA) to selected parameters was performed. Plasma concentration-time profiles after intravenous administration were forecast within an AAFE biopharmaceutics classification system (BCS) class. The reliability of literature permeability data was identified as a key issue in the accuracy of predicting oral drug absorption. For the four drugs studied, it appears that the forecasting accuracy of the PBPK models is related to the BCS class (BCS I > BCS II, BCS III > BCS IV). These results will need to be verified with additional drugs. © 2016 Royal Pharmaceutical Society.

  17. [Study on property of biopharmaceutics classification system of berberine in Huanglian decoction].

    Science.gov (United States)

    Wei, Li; Zhu, Mei-Ling; Dong, Yue-Liu; Dong, Ling; Liu, Yang; Chen, Jiang-Peng; Yin, Xiu-Wen

    2016-04-01

    The study of single component in the multicomponent environment is one of the basic researches for biopharmaceutics classification system of Chinese materia medica (CMMBCS). That is to say, the classification research shall be based on the respective lift of solubility and permeability in the multicomponent environment, besides solubility and intestinal permeability of the single component. We chose berberine as the main research object to investigate the changes of its solubility and intestinal permeability in Huanglian decoction. Shake-flask and HPLC were used to detect the solubility of berberine in different pH buffer solutions and different concentrations of Huanglian decoction. In situ single-pass intestinal perfusion (SPIP) and intestinal perfusion with venous sampling (IPVS) were carried out to study berberine's intestinal absorption and absorption into blood, respectively. Copyright© by the Chinese Pharmaceutical Association.

  18. Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.

    Science.gov (United States)

    Mehta, Mehul U; Uppoor, Ramana S; Conner, Dale P; Seo, Paul; Vaidyanathan, Jayabharathi; Volpe, Donna A; Stier, Ethan; Chilukuri, Dakshina; Dorantes, Angelica; Ghosh, Tapash; Mandula, Haritha; Raines, Kimberly; Dhanormchitphong, Pariban; Woodcock, Janet; Yu, Lawrence X

    2017-12-04

    The FDA guidance on application of the biopharmaceutics classification system (BCS) for waiver of in vivo bioequivalence (BE) studies was issued in August 2000. Since then, this guidance has created worldwide interest among biopharmaceutical scientists in regulatory agencies, academia, and industry toward its implementation and further expansion. This article describes how the review implementation of this guidance was undertaken at the FDA and results of these efforts over last dozen years or so across the new, and the generic, drug domains are provided. Results show that greater than 160 applications were approved, or tentatively approved, based on the BCS approach across multiple therapeutic areas; an additional significant finding was that at least 50% of these approvals were in the central nervous system (CNS) area. These findings indicate a robust utilization of the BCS approach toward reducing unnecessary in vivo BE studies and speeding up availability of high quality pharmaceutical products. The article concludes with a look at the adoption of this framework by regulatory and health policy organizations across the globe, and FDA's current thinking on areas of improvement of this guidance.

  19. Considerations for a Pediatric Biopharmaceutics Classification System (BCS): application to five drugs.

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    Gandhi, Shivani V; Rodriguez, William; Khan, Mansoor; Polli, James E

    2014-06-01

    It has been advocated that biopharmaceutic risk assessment should be conducted early in pediatric product development and synchronized with the adult product development program. However, we are unaware of efforts to classify drugs into a Biopharmaceutics Classification System (BCS) framework for pediatric patients. The objective was to classify five drugs into a potential BCS. These five drugs were selected since both oral and intravenous pharmacokinetic data were available for each drug, and covered the four BCS classes in adults. Literature searches for each drug were conducted using Medline and applied to classify drugs with respect to solubility and permeability in pediatric subpopulations. Four pediatric subpopulations were considered: neonates, infants, children, and adolescents. Regarding solubility, dose numbers were calculated using a volume for each subpopulation based on body surface area (BSA) relative to 250 ml for a 1.73 m(2) adult. Dose numbers spanned a range of values, depending upon the pediatric dose formula and subpopulation. Regarding permeability, pharmacokinetic literature data required assumptions and decisions about data collection. Using a devised pediatric BCS framework, there was agreement in adult and pediatric BCS class for two drugs, azithromycin (class 3) and ciprofloxacin (class 4). There was discordance for the three drugs that have high adult permeability since all pediatric permeabilities were low: dolasetron (class 3 in pediatric), ketoprofen (class 4 in pediatric), and voriconazole (class 4 in pediatric). A main contribution of this work is the identification of critical factors required for a pediatric BCS.

  20. [Impacts of multicomponent environment on solubility of puerarin in biopharmaceutics classification system of Chinese materia medica].

    Science.gov (United States)

    Hou, Cheng-Bo; Wang, Guo-Peng; Zhang, Qiang; Yang, Wen-Ning; Lv, Bei-Ran; Wei, Li; Dong, Ling

    2014-12-01

    To illustrate the solubility involved in biopharmaceutics classification system of Chinese materia medica (CMMBCS) , the influences of artificial multicomponent environment on solubility were investigated in this study. Mathematical model was built to describe the variation trend of their influence on the solubility of puerarin. Carried out with progressive levels, single component environment: baicalin, berberine and glycyrrhizic acid; double-component environment: baicalin and glycyrrhizic acid, baicalin and berberine and glycyrrhizic acid and berberine; and treble-component environment: baicalin, berberin, glycyrrhizic acid were used to describe the variation tendency of their influences on the solubility of puerarin, respectively. And then, the mathematical regression equation model was established to characterize the solubility of puerarin under multicomponent environment.

  1. A century of dissolution research: from Noyes and Whitney to the biopharmaceutics classification system.

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    Dokoumetzidis, Aristides; Macheras, Panos

    2006-09-14

    Dissolution research started to develop about 100 years ago as a field of physical chemistry and since then important progress has been made. However, explicit interest in drug related dissolution has grown only since the realisation that dissolution is an important factor of drug bioavailability in the 1950s. This review attempts to account the most important developments in the field, from a historical point of view. It is structured in a chronological order, from the theoretical foundations of dissolution, developed in the first half of the 20th century, and the development of a relationship between dissolution and bioavailability in the 1950s, going to the more recent developments in the framework of the Biopharmaceutics Classification System (BCS). Research on relevant fields of pharmaceutical technology, like sustained release formulations, where drug dissolution plays an important role, is reviewed. The review concludes with the modern trends on drug dissolution research and their regulatory implications.

  2. Classification of natural products as sources of drugs according to the biopharmaceutics drug disposition classification system (BDDCS).

    Science.gov (United States)

    Li, Ji; Larregieu, Caroline A; Benet, Leslie Z

    2016-12-01

    Natural products (NPs) are compounds that are derived from natural sources such as plants, animals, and micro-organisms. Therapeutics has benefited from numerous drug classes derived from natural product sources. The Biopharmaceutics Drug Disposition Classification System (BDDCS) was proposed to serve as a basis for predicting the importance of transporters and enzymes in determining drug bioavailability and disposition. It categorizes drugs into one of four biopharmaceutical classes according to their water solubility and extent of metabolism. The present paper reviews 109 drugs from natural product sources: 29% belong to class 1 (high solubility, extensive metabolism), 22% to class 2 (low solubility, extensive metabolism), 40% to class 3 (high solubility, poor metabolism), and 9% to class 4 (low solubility, poor metabolism). Herein we evaluated the characteristics of NPs in terms of BDDCS class for all 109 drugs as wells as for subsets of NPs drugs derived from plant sources as antibiotics. In the 109 NPs drugs, we compiled 32 drugs from plants, 50% (16) of total in class 1, 22% (7) in class 2 and 28% (9) in class 3, none found in class 4; Meantime, the antibiotics were found 5 (16%) in class 2, 22 (71%) in class 3, and 4 (13%) in class 4; no drug was found in class 1. Based on this classification, we anticipate BDDCS to serve as a useful adjunct in evaluating the potential characteristics of new natural products. Copyright © 2016 China Pharmaceutical University. Published by Elsevier B.V. All rights reserved.

  3. Pediatric Biopharmaceutical Classification System: Using Age-Appropriate Initial Gastric Volume.

    Science.gov (United States)

    Shawahna, Ramzi

    2016-05-01

    Development of optimized pediatric formulations for oral administration can be challenging, time consuming, and financially intensive process. Since its inception, the biopharmaceutical classification system (BCS) has facilitated the development of oral drug formulations destined for adults. At least theoretically, the BCS principles are applied also to pediatrics. A comprehensive age-appropriate BCS has not been fully developed. The objective of this work was to provisionally classify oral drugs listed on the latest World Health Organization's Essential Medicines List for Children into an age-appropriate BCS. A total of 38 orally administered drugs were included in this classification. Dose numbers were calculated using age-appropriate initial gastric volume for neonates, 6-month-old infants, and children aging 1 year through adulthood. Using age-appropriate initial gastric volume and British National Formulary age-specific dosing recommendations in the calculation of dose numbers, the solubility classes shifted from low to high in pediatric subpopulations of 12 years and older for amoxicillin, 5 years, 12 years and older for cephalexin, 9 years and older for chloramphenicol, 3-4 years, 9-11 and 15 years and older for diazepam, 18 years and older (adult) for doxycycline and erythromycin, 8 years and older for phenobarbital, 10 years and older for prednisolone, and 15 years and older for trimethoprim. Pediatric biopharmaceutics are not fully understood where several knowledge gaps have been recently emphasized. The current biowaiver criteria are not suitable for safe application in all pediatric populations.

  4. Generative topographic mapping-based classification models and their applicability domain: application to the biopharmaceutics Drug Disposition Classification System (BDDCS).

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    Gaspar, Héléna A; Marcou, Gilles; Horvath, Dragos; Arault, Alban; Lozano, Sylvain; Vayer, Philippe; Varnek, Alexandre

    2013-12-23

    Earlier (Kireeva et al. Mol. Inf. 2012, 31, 301-312), we demonstrated that generative topographic mapping (GTM) can be efficiently used both for data visualization and building of classification models in the initial D-dimensional space of molecular descriptors. Here, we describe the modeling in two-dimensional latent space for the four classes of the BioPharmaceutics Drug Disposition Classification System (BDDCS) involving VolSurf descriptors. Three new definitions of the applicability domain (AD) of models have been suggested: one class-independent AD which considers the GTM likelihood and two class-dependent ADs considering respectively, either the predominant class in a given node of the map or informational entropy. The class entropy AD was found to be the most efficient for the BDDCS modeling. The predominant class AD can be directly visualized on GTM maps, which helps the interpretation of the model.

  5. Towards the development of a paediatric biopharmaceutics classification system: Results of a survey of experts.

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    Batchelor, Hannah; Ernest, Terry; Flanagan, Talia; Klein, Sandra; Turner, Roy; Fotaki, Nikoletta; Storey, David

    2016-09-25

    The aim of this research survey was to understand current global thinking around the need for and development of a paediatric biopharmaceutics classification system (pBCS) to be used for the development of paediatric medicines and regulatory purposes (e.g. Biowaivers). A literature review highlighted the paucity of data in this area and therefore a survey was developed to better understand this topic to identify areas of common thinking and highlight future research needs. Global experts in paediatric biopharmaceutics were identified from existing networks and public forums. An online survey was developed and circulated broadly to maximise participation. Sixty individuals (including academics, health care professionals, pharmaceutical industry scientists and regulators) completed the survey, bringing together their views on the need for a pBCS. The results highlighted that the area of greatest concern was the definition of BCS II and IV drugs within this population and additional research is required to generate evidence to underpin this issue. In questions relating to permeability and dissolution consensus was generally reached within the expert population suggesting that little additional research is required to define suitable criteria. More than 90% of those experts who participated agreed that a pBCS would be useful for paediatric populations with a greater need identified for the younger populations (newborn and infants compared to adolescents). The results presented will facilitate further discussion and research into the evidence to underpin a relevant pBCS. These results highlight the need for additional evidence and guidance in this area. Copyright © 2016. Published by Elsevier B.V.

  6. Quantitative biopharmaceutics classification system: the central role of dose/solubility ratio.

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    Rinaki, Eleni; Valsami, Georgia; Macheras, Panos

    2003-12-01

    To develop a quantitative biopharmaceutics drug classification system (QBCS) based on fundamental parameters controlling rate and extent of absorption. A simple absorption model that considers transit flow, dissolution, and permeation processes stochastically was used to illustrate the primary importance of dose/solubility ratio and permeability on drug absorption. Simple mean time considerations for dissolution, uptake, and transit were used to identify relationships between the extent of absorption and a drug's dissolution and permeability characteristics. The QBCS developed relies on a (permeability, dose/ solubility ratio) plane with cutoff points 2 x 10(-6)-10(-5) cm/s for the permeability and 0.5-1 (unitless) for the dose/solubility ratio axes. Permeability estimates, P(app) are derived from Caco-2 studies, and a constant intestinal volume content of 250 ml is used to express the dose/solubility ratio as a dimensionless quantity, q. A physiologic range of 250-500 ml was used to account for variability in the intestinal volume. Drugs are classified into the four quadrants of the plane around the cutoff points according to their P(app), q values, establishing four drug categories. i.e., I (P(app) > 10(-5) cm/s, q 10(-5) cm/s, q > 1), III (P(app) 1). A region for borderline drugs (2 x 10(-6) biopharmaceutical properties, permeability, and dose/solubility ratio. Semiquantitative predictions for the extent of absorption are essentially based on these drug properties, which either determine or are strongly related to the in vivo kinetics of drug dissolution and intestinal wall permeation.

  7. Effects of uremic toxins on transport and metabolism of different biopharmaceutics drug disposition classification system xenobiotics.

    Science.gov (United States)

    Reyes, Maribel; Benet, Leslie Z

    2011-09-01

    Chronic kidney disease (CKD) is recognized to cause pharmacokinetic changes in renally excreted drugs; however, pharmacokinetic changes are also reported for drugs that are nonrenally eliminated. Few studies have investigated how uremic toxins may affect drug transporters and metabolizing enzymes and how these may result in pharmacokinetic/metabolic changes in CKD. Here, we investigated the effects of uremic toxins and human uremic serum on the transport of the prototypical transporter substrate [(3) H]-estrone sulfate and three Biopharmaceutics Drug Disposition Classification System (BDDCS) drugs, propranolol, losartan, and eprosartan. We observed a significant decrease in [(3) H]-estrone sulfate, losartan, and eprosartan uptake with some uremic toxins in both transfected cells and rat hepatocytes. The uptake of losartan was decreased in rat and human hepatocytes (28% and 48%, respectively) in the presence of hemodialysis (HD) serum. Time-course studies of losartan showed a 27%, 65%, and 68% increase in area under the curve (AUC) in the presence of HD serum, rifampin, and sulfaphenazole, respectively. Intracellular losartan AUC decreased significantly in the treatment groups, and the metabolite AUC decreased by 41% and 26% in rifampin- and sulfaphenazole-treated group, respectively. The intracellular AUC of eprosartan increased 190% in the presence of HD serum. These studies indicate that the uremic toxins contained in HD serum play an important role in drug disposition through drug transporters, and that there would be differential effects depending on the BDDCS classification of the drug. Copyright © 2011 Wiley-Liss, Inc.

  8. The Biopharmaceutics Classification System: subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC.

    Science.gov (United States)

    Tsume, Yasuhiro; Mudie, Deanna M; Langguth, Peter; Amidon, Greg E; Amidon, Gordon L

    2014-06-16

    The Biopharmaceutics Classification System (BCS) has found widespread utility in drug discovery, product development and drug product regulatory sciences. The classification scheme captures the two most significant factors influencing oral drug absorption; solubility and intestinal permeability and it has proven to be a very useful and a widely accepted starting point for drug product development and drug product regulation. The mechanistic base of the BCS approach has, no doubt, contributed to its wide spread acceptance and utility. Nevertheless, underneath the simplicity of BCS are many detailed complexities, both in vitro and in vivo which must be evaluated and investigated for any given drug and drug product. In this manuscript we propose a simple extension of the BCS classes to include sub-specification of acid (a), base (b) and neutral (c) for classes II and IV. Sub-classification for Classes I and III (high solubility drugs as currently defined) is generally not needed except perhaps in border line solubility cases. It is well known that the , pKa physical property of a drug (API) has a significant impact on the aqueous solubility dissolution of drug from the drug product both in vitro and in vivo for BCS Class II and IV acids and bases, and is the basis, we propose for a sub-classification extension of the original BCS classification. This BCS sub-classification is particularly important for in vivo predictive dissolution methodology development due to the complex and variable in vivo environment in the gastrointestinal tract, with its changing pH, buffer capacity, luminal volume, surfactant luminal conditions, permeability profile along the gastrointestinal tract and variable transit and fasted and fed states. We believe this sub-classification is a step toward developing a more science-based mechanistic in vivo predictive dissolution (IPD) methodology. Such a dissolution methodology can be used by development scientists to assess the likelihood of a

  9. Lipid Based Formulations of Biopharmaceutics Classification System (BCS Class II Drugs: Strategy, Formulations, Methods and Saturation

    Directory of Open Access Journals (Sweden)

    Šoltýsová I.

    2016-12-01

    Full Text Available Active ingredients in pharmaceuticals differ by their physico-chemical properties and their bioavailability therefore varies. The most frequently used and most convenient way of administration of medicines is oral, however many drugs are little soluble in water. Thus they are not sufficiently effective and suitable for such administration. For this reason a system of lipid based formulations (LBF was developed. Series of formulations were prepared and tested in water and biorelevant media. On the basis of selection criteria, there were selected formulations with the best emulsification potential, good dispersion in the environment and physical stability. Samples of structurally different drugs included in the Class II of the Biopharmaceutics classification system (BCS were obtained, namely Griseofulvin, Glibenclamide, Carbamazepine, Haloperidol, Itraconazol, Triclosan, Praziquantel and Rifaximin, for testing of maximal saturation in formulations prepared from commercially available excipients. Methods were developed for preparation of formulations, observation of emulsification and its description, determination of maximum solubility of drug samples in the respective formulation and subsequent analysis. Saturation of formulations with drugs showed that formulations 80 % XA and 20 % Xh, 35 % XF and 65 % Xh were best able to dissolve the drugs which supports the hypothesis that it is desirable to identify limited series of formulations which could be generally applied for this purpose.

  10. Physicochemical properties of lomefloxacin, levofloxacin, and moxifloxacin relevant to the biopharmaceutics classification system.

    Science.gov (United States)

    Kłosińska-Szmurło, Ewa; Grudzień, Monika; Betlejewska-Kielak, Katarzyna; Pluciński, Franciszek; Biernacka, Joanna; Mazurek, Aleksander Paweł

    2014-01-01

    The aim of this investigation was to identify the impact of physicochemical properties of three fluoroquinolones (second, third, and fourth generation) on bioavailability in relation to the Biopharmaceutics Classification System (BCS) by in silico and in vitro methods. These properties were estimated by analyzing the electrostatic potential pattern and values of the free energy of solvation as well as the distribution coefficients and true partition coefficients of the studied compounds. This study was based on theoretical quantum-chemical methods and the in vitro shake-flask technique with two immiscible phases (n-octanol and phosphate buffer) as well as the experimental potentiometric method to estimate protonation macro- and micro-constants. Properties identified in the in vitro and in silico studies were similar and indicated high lipophilic properties of the studied molecules as well as their good solubility in a polar medium. It appears that both the theoretical methods and simple in vitro studies are useful tools for predicting the bioavailability of medicinal substances based on the BCS principles.

  11. Rapid in vivo dissolution of ketoprofen: implications on the biopharmaceutics classification system.

    Science.gov (United States)

    Granero, G E; Ramachandran, C; Amidon, G L

    2006-08-01

    The aim of this paper was to investigate the in vivo dissolution behavior of ketoprofen, a Class II drug according to the Biopharmaceutics Classification System (BCS), in the upper small intestine of dogs. An intubations method was used, where no blocking balloons were used to prevent luminal drug transport along the GI tract. Our design allowed the drug to be transported freely to more distal parts of the GI tract and also, it was supported by a pharmacokinetic study. Pharmacokinetic parameters of ketoprofen were determined in dogs after administering approximately 0.27 mg kg(-1) (solution) or approximately 1.47 mg kg(-1) (suspension) in oral bolus doses. There were not statistical significant differences in plasma concentrations for both formulations, either in the maximum concentrations C(max) or AUC following oral dose administration. The rapid disappearance of ketoprofen from the intestinal lumen, reflected by low mass recovery in the supernatant and sediment of the collected intestinal fluid samples, in comparison to that recovery of the non-absorbable marker phenol red, suggests that ketoprofen is emptying into the small intestine and is rapidly dissolved and absorbed. In this study, the in vivo results clearly show that the absorption rate of ketoprofen is not dissolution limited; therefore ketoprofen would be essentially equivalent to Class I drugs and could be considered for waiver of bioavailability and bioequivalence testing.

  12. Biowaiver approach for biopharmaceutics classification system class 3 compound metformin hydrochloride using in silico modeling.

    Science.gov (United States)

    Crison, John R; Timmins, Peter; Keung, Anther; Upreti, Vijay V; Boulton, David W; Scheer, Barry J

    2012-05-01

    The dependency of metformin in vivo disposition on the rate and extent of dissolution was studied. The analysis includes the use of fundamental principles of drug input, permeability, and intestinal transit time within the framework of a compartmental absorption transit model to predict key pharmacokinetic (PK) parameters and then compare the results to clinical data. The simulations show that the maximum plasma concentration (C(max) ) and area under the curve (AUC) are not significantly affected when 100% of drug is released within 2 h of oral dosing, which was confirmed with corresponding human PK data. Furthermore, in vitro dissolution profiles measured in aqueous buffers at pH values of 1.2, 4.5, and 6.8 were slower than in vivo release profiles generated by deconvolution of metformin products that were bioequivalent. On the basis of this work, formulations of metformin that release 100% in vitro in a   time period equal to or less than two hours are indicated to be bioequivalent. The use of modeling offers a mechanistic-based approach for demonstrating acceptable bioperformance for metformin formulations without having to resort to in vivo bioequivalence studies and may be more robust than statistical comparison of in vitro release profiles. This work further provides a strategy for considering Biopharmaceutics Classification System (BCS) Class 3 compounds to be included under biowaiver guidelines as for BCS Class 1 compounds. Copyright © 2012 Wiley Periodicals, Inc.

  13. Biopharmaceutics classification system-based biowaivers for generic oncology drug products: case studies.

    Science.gov (United States)

    Tampal, Nilufer; Mandula, Haritha; Zhang, Hongling; Li, Bing V; Nguyen, Hoainhon; Conner, Dale P

    2015-02-01

    Establishing bioequivalence (BE) of drugs indicated to treat cancer poses special challenges. For ethical reasons, often, the studies need to be conducted in cancer patients rather than in healthy volunteers, especially when the drug is cytotoxic. The Biopharmaceutics Classification System (BCS) introduced by Amidon (1) and adopted by the FDA, presents opportunities to avoid conducting the bioequivalence studies in humans. This paper analyzes the application of the BCS approach by the generic pharmaceutical industry and the FDA to oncology drug products. To date, the FDA has granted BCS-based biowaivers for several drug products involving at least four different drug substances, used to treat cancer. Compared to in vivo BE studies, development of data to justify BCS waivers is considered somewhat easier, faster, and more cost effective. However, the FDA experience shows that the approval times for applications containing in vitro studies to support the BCS-based biowaivers are often as long as the applications containing in vivo BE studies, primarily because of inadequate information in the submissions. This paper deliberates some common causes for the delays in the approval of applications requesting BCS-based biowaivers for oncology drug products. Scientific considerations of conducting a non-BCS-based in vivo BE study for generic oncology drug products are also discussed. It is hoped that the information provided in our study would help the applicants to improve the quality of ANDA submissions in the future.

  14. Biopharmaceutics classification system: validation and learnings of an in vitro permeability assay.

    Science.gov (United States)

    Thiel-Demby, Victoria E; Humphreys, Joan E; St John Williams, Lisa A; Ellens, Harma M; Shah, Nipa; Ayrton, Andrew D; Polli, Joseph W

    2009-01-01

    The Biopharmaceutics Classification System (BCS) is the scientific basis for classifying drugs based on their aqueous solubility and intestinal permeability that supports in vivo bioavailability and bioequivalence waivers for immediate-release solid dosage form drugs. One requirement of the BCS is that the permeability method must be validated. In order to accommodate the variety of in vitro/in situ permeability models, the BCS Guidance gives a general framework for the validation requirements, necessitating implemented experimental details to be selected by the applicant laboratory. The objective of this work was to define the parameters for a cell based in vitro permeability method (e.g., cell type, pH, transport direction, time, and concentration) and validate the method to support formal BCS classification of drugs. Twenty reference drugs were selected and permeability values determined using the Madin-Darby canine kidney type II cell line heterologously expressing the human P-glycoprotein transporter (MDCKII-MDR1). A rank order relationship was established between the in vitro permeability value and human intestinal absorption values. This relationship was as predicted and validates the MDCKII-MDR1 permeability method as defined by the BCS Guidance. The final validated in vitro permeability method employs the MDCKII-MDR1 cell line incubated with the Pgp inhibitor GF120918. It is a unidirectional apical-to-basolateral transport assay performed at apical pH values of 5.5 and 7.4 and a basolateral pH of 7.4. Four reference standards (metoprolol, pindolol, labetalol and ranitidine) dosed and analyzed as a single cassette are included in each experiment. A strategy on selection of drug concentrations and on how to deal with problematic compounds (i.e., those suffering from poor mass balance) is discussed.

  15. Predicting drug disposition via application of a Biopharmaceutics Drug Disposition Classification System.

    Science.gov (United States)

    Benet, Leslie Z

    2010-03-01

    A Biopharmaceutics Drug Disposition Classification System (BDDCS) was proposed to serve as a basis for predicting the importance of transporters in determining drug bioavailability and disposition. BDDCS may be useful in predicting: routes of drug elimination; efflux and absorptive transporters effects on oral absorption; when transporter-enzyme interplay will yield clinically significant effects (e.g. low drug bioavailability and drug-drug interactions); and transporter effects on post-absorptive systemic drug levels following oral and i.v. dosing. For highly soluble, highly permeable Class 1 compounds, metabolism is the major route of elimination and transporter effects on drug bioavailability and hepatic disposition are negligible. In contrast for the poorly permeable Class 3 and 4 compounds, metabolism only plays a minor role in drug elimination. Uptake transporters are major determinants of drug bioavailability for these poorly permeable drugs and both uptake and efflux transporters could be important for drug elimination. Highly permeable, poorly soluble, extensively metabolized Class 2 compounds present the most complicated relationship in defining the impact of transporters due to a marked transporter-enzyme interplay. Uptake transporters are unimportant for Class 2 drug bioavailability, (ensure space after,) but can play a major role in hepatic and renal elimination. Efflux transporters have major effects on drug bioavailability, absorption, metabolism and elimination of Class 2 drugs. It is difficult to accurately characterize drugs in terms of the high permeability criteria, i.e. > or =90% absorbed. We suggest that extensive metabolism may substitute for the high permeability characteristic, and that BDDCS using elimination criteria may provide predictability in characterizing drug disposition profiles for all classes of compounds.

  16. Formulation design for poorly water-soluble drugs based on biopharmaceutics classification system: basic approaches and practical applications.

    Science.gov (United States)

    Kawabata, Yohei; Wada, Koichi; Nakatani, Manabu; Yamada, Shizuo; Onoue, Satomi

    2011-11-25

    The poor oral bioavailability arising from poor aqueous solubility should make drug research and development more difficult. Various approaches have been developed with a focus on enhancement of the solubility, dissolution rate, and oral bioavailability of poorly water-soluble drugs. To complete development works within a limited amount of time, the establishment of a suitable formulation strategy should be a key consideration for the pharmaceutical development of poorly water-soluble drugs. In this article, viable formulation options are reviewed on the basis of the biopharmaceutics classification system of drug substances. The article describes the basic approaches for poorly water-soluble drugs, such as crystal modification, micronization, amorphization, self-emulsification, cyclodextrin complexation, and pH modification. Literature-based examples of the formulation options for poorly water-soluble compounds and their practical application to marketed products are also provided. Classification of drug candidates based on their biopharmaceutical properties can provide an indication of the difficulty of drug development works. A better understanding of the physicochemical and biopharmaceutical properties of drug substances and the limitations of each delivery option should lead to efficient formulation development for poorly water-soluble drugs. Copyright © 2011 Elsevier B.V. All rights reserved.

  17. Summary of the NICHD-BPCA Pediatric Formulation Initiatives Workshop-Pediatric Biopharmaceutics Classification System (PBCS) Working Group

    Science.gov (United States)

    Abdel-Rahman, Susan; Amidon, Gordon L.; Kaul, Ajay; Lukacova, Viera; Vinks, Alexander A.; Knipp, Gregory

    2012-01-01

    The Biopharmaceutics Classification System (BCS) allows compounds to be classified based on their in vitro solubility and intestinal permeability. The BCS has found widespread use in the pharmaceutical community as an enabling guide for the rational selection of compounds, formulation for clinical advancement and generic biowaivers. The Pediatric Biopharmaceutics Classification System (PBCS) working group was convened to consider the possibility of developing an analogous pediatric based classification system. Since there are distinct developmental differences that can alter intestinal contents, volumes, permeability and potentially biorelevant solubilities at the different ages, the PBCS working group focused on identifying age specific issues that would need to be considered in establishing a flexible, yet rigorous PBCS. Objective To summarize the findings of the PBCS working group and provide insights into considerations required for the development of a pediatric based biopharmaceutics classification system. Methods Through several meetings conducted both at The Eunice Kennedy Shriver National Institute of Child Health, Human Development (NICHD)-US Pediatric Formulation Initiative (PFI) workshop (November 2011) and via teleconferences, the PBCS working group considered several high level questions that were raised to frame the classification system. In addition, the PBCS working group identified a number of knowledge gaps that would need to be addressed in order to develop a rigorous PBCS. Results It was determined that for a PBCS to be truly meaningful, it would need to be broken down into several different age groups that would account for developmental changes in intestinal permeability, luminal contents, and gastrointestinal transit. Several critical knowledge gaps where identified including: 1) a lack of fully understanding the ontogeny of drug metabolizing enzymes and transporters along the gastrointestinal (GI) tract, in the liver and in the kidney; 2

  18. [Effect of multicomponent environment on intestinal permeability of puerarin in biopharmaceutics classification system of Chinese materia medica].

    Science.gov (United States)

    Liu, Yang; Wang, Gang; Dong, Ling; Tang, Ming-Min; Zhu, Mei-Ling; Dong, Hong-Huant; Hou, Cheng-Bo

    2014-12-01

    The evaluation of permeability in biopharmaceutics classification system of Chinese materia medica (CMMBCS) requires multicomponent as a whole in order to conduct research, even in the study of a specific component, should also be put in the multicomponent environment. Based on this principle, the high content components in Gegen Qinlian decoction were used as multicomponent environmental impact factors in the experiment, and the relevant parameters of intestinal permeability about puerarin were measured with using in situ single-pass intestinal perfusion model, to investigate and evaluate the intestinal permeability of puerarin with other high content components. The experimental results showed that different proportions of baicalin, glycyrrhizic acid and berberine had certain influence on intestinal permeability of puerarin, and glycyrrhizic acid could significantly inhibit the intestinal absorption of puerarin, moreover, high concentration of berberine could promote the absorption of puerarin. The research results indicated that the important research ideas of permeability evaluation in biopharmaceutics classification system of Chinese materia medica with fully considering the effects of other ingredients in multicomponent environment.

  19. Feasibility of biowaiver extension to biopharmaceutics classification system class III drug products: cimetidine.

    Science.gov (United States)

    Jantratid, Ekarat; Prakongpan, Sompol; Amidon, Gordon L; Dressman, Jennifer B

    2006-01-01

    The extension of biowaivers (drug product approval without a pharmacokinetic bioequivalence study) to drugs belonging to Class III of the Biopharmaceutics Classification System (BCS) is currently a subject of much discussion. To assess the relationship between in vitro dissolution characteristics and in vivo absorption performance of immediate-release (IR) products containing cimetidine, a BCS Class III compound, in human subjects. To evaluate the feasibility and appropriateness of an extension of the biowaiver concept to BCS Class III compounds. BCS-conform dissolution tests were carried out on ten marketed cimetidine products from Thailand and Germany, as well as cimetidine tablet formulations containing cimetidine 400mg manufactured by direct compression using methacrylate copolymer (Eudragit) RS PO) as a release-retarding agent to yield three batches with significantly different release profiles. Twelve healthy male subjects were enrolled in a randomised, open-label, single-dose schedule based on a five-way Williams' design balanced for carryover effects. Subjects received the following treatments, with 1-week washout periods between: (i) Tagamet 400mg tablet; (ii) 7.5% methacrylate copolymer cimetidine tablet; (iii) 15% methacrylate copolymer cimetidine tablet; (iv) 26% methacrylate copolymer cimetidine tablet; and (v) Tagamet (300 mg/ 2 mL) intravenous injection. The area under the plasma concentration-time curve from 0 to 12 hours (AUC(12)) and AUC from time zero to infinity (AUC(infinity)), peak plasma concentration (C(max)), absolute bioavailability (F) and mean residence time (MRT) were evaluated and statistically compared among formulations. In vitro-in vivo correlation (IVIVC) analysis was then applied to elucidate the overall absorption characteristics of each tablet formulation. The release properties of the ten marketed cimetidine products were shown to comply with current US FDA criteria for rapidly dissolving drug products. As expected, the in

  20. Hepatic Clearance Predictions from In Vitro-In Vivo Extrapolation and the Biopharmaceutics Drug Disposition Classification System.

    Science.gov (United States)

    Bowman, Christine M; Benet, Leslie Z

    2016-11-01

    Predicting in vivo pharmacokinetic parameters such as clearance from in vitro data is a crucial part of the drug-development process. There is a commonly cited trend that drugs that are highly protein-bound and are substrates for hepatic uptake transporters often yield the worst predictions. Given this information, 11 different data sets using human microsomes and hepatocytes were evaluated to search for trends in accuracy, extent of protein binding, and drug classification based on the Biopharmaceutics Drug Disposition Classification System (BDDCS), which makes predictions about transporter effects. As previously reported, both in vitro systems (microsomes and hepatocytes) gave a large number of inaccurate results, defined as predictions falling more than 2-fold outside of in vivo values. The weighted average of the percentage of inaccuracy was 66.5%. BDDCS class 2 drugs, which are subject to transporter effects in vivo unlike class 1 compounds, had a higher percentage of inaccurate predictions and often had slightly larger bias. However, since the weighted average of the percentage of inaccuracy was still high in both classes (81.9% for class 2 and 62.3% for class 1), it may be currently hard to use BDDCS class to predict potential accuracy. The results of this study emphasize the need for improved in vitro to in vivo extrapolation experimental methods, as using physiologically based scaling is still not accurate, and BDDCS cannot currently help predict accurate results. Copyright © 2016 by The American Society for Pharmacology and Experimental Therapeutics.

  1. Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir.

    Science.gov (United States)

    Vaithianathan, Soundarya; Haidar, Sam H; Zhang, Xinyuan; Jiang, Wenlei; Avon, Christopher; Dowling, Thomas C; Shao, Changxing; Kane, Maureen; Hoag, Stephen W; Flasar, Mark H; Ting, Tricia Y; Polli, James E

    2016-02-01

    The objective was to assess the impact of larger than conventional amounts of 14 commonly used excipients on Biopharmaceutics Classification System (BCS) class 3 drug absorption in humans. Cimetidine and acyclovir were used as model class 3 drugs across three separate four-way crossover bioequivalence (BE) studies (n = 24 each) in healthy human volunteers, denoted as study 1A, 1B, and 2. In study 1A and 1B, three capsule formulations of each drug were manufactured, collectively involving 14 common excipients. Capsule formulations that incorporated hydroxypropyl methylcellulose (HPMC) or magnesium stearate exhibited lower absorption. The cimetidine commercial solution contained sorbitol and also resulted in lower absorption. Hence, in study 2, two capsule formulations with lower amounts of HPMC and magnesium stearate, the sorbitol-containing commercial solution, and a sorbitol-free solution were assessed for BE. Overall, 12 common excipients were found in large amounts to not impact BCS class 3 drug absorption in humans, such that these excipients need not be qualitatively the same nor quantitatively very similar to reference, but rather simply be not more than the quantities studied here. Meanwhile, for each HPMC and microcrystalline cellulose, BCS class 3 biowaivers require these two excipients to be qualitatively the same and quantitatively very similar to the reference. Copyright © 2016. Published by Elsevier Inc.

  2. Effect on the Gastrointestinal Absorption of Drugs from Different Classes in the Biopharmaceutics Classification System, When Treating with Liraglutide.

    Science.gov (United States)

    Malm-Erjefält, Monika; Ekblom, Marianne; Vouis, Jan; Zdravkovic, Milan; Lennernäs, Hans

    2015-11-02

    Like other GLP-1 receptor agonists used for treatment of type 2 diabetes, liraglutide delays gastric emptying. In this clinical absorption study, the primary objective was to investigate the effect of liraglutide (at steady state) on the rate and/or extent of gastrointestinal (GI) absorption of concomitantly orally taken drugs from three classes of the Biopharmaceutics Classification System (BCS). To provide a general prediction on liraglutide drug-drug absorption interaction, single-dose pharmacokinetics of drugs representing BCS classes II (low solubility-high permeability; atorvastatin 40 mg and griseofulvin 500 mg), III (high solubility-low permeability; lisinopril 20 mg), and IV (low solubility-low permeability; digoxin 1 mg) were studied in healthy subjects at steady state of liraglutide 1.8 mg, or placebo, in a two-period crossover design. With liraglutide, the oral drugs atorvastatin, lisinopril, and digoxin showed delayed tmax (by ≤2 h) and did not meet the criterion for bioequivalence for Cmax (reduced Cmax by 27-38%); griseofulvin had similar tmax and 37% increased Cmax. Although the prespecified bioequivalence criterion was not met by all drugs, the overall plasma exposure (AUC) of griseofulvin, atorvastatin, lisinopril, and digoxin only exhibited minor changes and was not considered to be of clinical relevance.

  3. [Application of multicomponent dissolution evaluation method of biopharmaceutics classification system of Chinese materia medica in gegen qinlian tablets].

    Science.gov (United States)

    Wei, Li; Wang, Guo-Peng; Dong, Ling; Tang, Ming-Min; Zhang, Lei; Zhu, Mei-Ling; Liu, Yang

    2014-12-01

    The study is a paticular embodiment of Chinese patent medicine based on biopharmaceutics classification system of Chinese materia medica (CMMBCS) , focusing on assessment of synchronization issues of dissolution that may affect the timing of the multicomponent absorption. The accumulative dissolution percentages of nine components in Gengen Qinlian tablets in different dissolution solvents and times were determined by HPLC. The dissolution curve was drew and its similarity was evaluated by similarity factors (f2) and cluster method. Results in this experiment showed that the components that peak 7 and peak 8 (baicalin) represented had poor similarity with the reference peak 2 (puerarin). Their similarity factors were both 43 in water dissolution media and 31 and 45 in pH 7.4 dissolution media, respectively. Components that peaks represented had better similarity with the reference peak 2 (puerarin) in other medium. It illustrated that components that peak 3,4,5,6 (berberine) represented had fully synchronous dissolution characteristics with the reference peak 2 (puerarin), components peak 1 and 9 represented had nearly fully synchronous dissolution characteristics with the reference peak 2 (puerarin), while components that peak 7 and 8 (baicalin) represented had no synchronous dissolution characteristics with the reference peak 2 (puerarin).

  4. The "high solubility" definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs.

    Science.gov (United States)

    Yazdanian, Mehran; Briggs, Katherine; Jankovsky, Corinne; Hawi, Amale

    2004-02-01

    The purpose of this study was to assess if the definition of high solubility as proposed in the FDA Guidance on Biopharmaceutical Classification System (BCS) is too strict for highly permeable acidic drugs. The solubility and permeability values of 20 (18 acidic and 2 non-acidic) nonsteroidal anti-inflammatory drugs (NSAID) were determined. The NSAIDs were grouped into three different sets having acetic acid, propionic acid, or other acidic moieties such as fenamate, oxicam, and salicylate. Two nonacidic NSAIDs (celecoxib and rofecoxib) were also included for comparison purposes. Equilibrium solubility values were determined at pH 1.2, 5.0, 7.4, and in biorelevant media simulating fed intestinal fluid at pH 5.0. For a select number of acids, we also measured solubility values in media simulating gastric and fasted intestinal fluids. Permeability classification was established relative to that of reference drugs in the Caco-2 cell permeability model. Permeability coefficients for all drugs were measured at concentrations corresponding to the lowest and highest marketed dose strengths dissolved in 250 ml volume, and their potential interaction with cellular efflux pumps was investigated. All NSAIDs with different acidic functional groups were classified as highly permeable based on their Caco-2 cell permeability. Only ketorolac appeared to have a potential for interaction with cellular efflux pumps. Solubility classification was based on comparison of equilibrium solubility at pH 1.2, 5.0. and 7.4 relative to marketed dose strengths in 250 ml. The pKa values for the acidic NSAIDs studied were between 3.5 and 5.1. and, as expected, their solubility increased dramatically at pH 7.4 compared to pH 1.2. Only three NSAIDs, ketorolac, ketoprofen. and acetyl salicylic acid, meet the current criteria for high solubility over the entire pH range. However, with the exception of ibuprofen, oxaprozin, and mefenamic acid, the remaining compounds can be classified as Class I drugs

  5. Predicting drug disposition via application of BCS: transport/absorption/ elimination interplay and development of a biopharmaceutics drug disposition classification system.

    Science.gov (United States)

    Wu, Chi-Yuan; Benet, Leslie Z

    2005-01-01

    The Biopharmaceutics Classification System (BCS) was developed to allow prediction of in vivo pharmacokinetic performance of drug products from measurements of permeability (determined as the extent of oral absorption) and solubility. Here, we suggest that a modified version of such a classification system may be useful in predicting overall drug disposition, including routes of drug elimination and the effects of efflux and absorptive transporters on oral drug absorption; when transporter-enzyme interplay will yield clinically significant effects (e.g., low bioavailability and drug-drug interactions); the direction, mechanism, and importance of food effects; and transporter effects on postabsorption systemic drug concentrations following oral and intravenous dosing. These predictions are supported by a series of studies from our laboratory during the past few years investigating the effect of transporter inhibition and induction on drug metabolism. We conclude by suggesting that a Biopharmaceutics Drug Disposition Classification System (BDDCS) using elimination criteria may expand the number of Class 1 drugs eligible for a waiver of in vivo bioequivalence studies and provide predictability of drug disposition profiles for Classes 2, 3, and 4 compounds.

  6. In vitro evaluation of extemporaneously compounded immediate-release capsules with premixed excipients, based on the biopharmaceutics classification system (BCS) of the drugs.

    Science.gov (United States)

    Pinheiro, Vanessa A; Danopoulos, Panagiota; Demirdjian, Lara; Nogueira, Rodrigo J L; Dubois, Fanny

    2013-01-01

    Hard-capsule compounding plays an essential role in drug delivery for pharmaceutical application. Versatile and easy to use, capsules represent a popular dosage form for patients. Nevertheless, bioavailability of the drugs compounded in hard capsules is not always optimized and choosing the appropriate excipients is a key factor to improve the dissolution kinetics of active pharmaceutical ingredients. The Biopharmaceutical Classification System, which categorizes drugs regarding their solubility and permeability, is a unique tool which can be used to select the most compatible excipients for a particular drug when compounding immediate-release capsules. The aim of this study was to evaluate the efficiency of premixed excipient blends called CapsuBlend Excipients, based on the Biopharmaceutical Classification System concept, for drug dissolution rate and absorption enhancement. Drug assay and dissolution profiles were studied for three batches of metronidazole 250-mg, theophylline 100-mg, and levocarnitine 250-mg capsules, each respectively representing a highly soluble, poorly soluble, and hygroscopic drug. Methods followed the specifications set forth in the United States Pharmacopeia. Assay results demonstrated that each batch of metronidazole 250 mg, theophylline 100 mg, and levocarnitine 250 mg contained not less than 90.0% of and not more than 110.0% of the labeled amount of drug, which is in accordance with the United States Pharmacopeia requirements. Moreover, dissolution profile results for the aforementioned capsules depicted dissolution values meeting the Pharmacopeial criteria of acceptance. These results reinforce the fact that the Biopharmaceutical Classification System concept represents a valuable guideline for formulation chemists or pharmacists to assist them for capsule compounding. To ensure a high level of efficiency of compounded capsules, premixed excipient blends, carefully developed by taking into consideration the solubility and

  7. Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: verapamil hydrochloride, propranolol hydrochloride, and atenolol.

    Science.gov (United States)

    Vogelpoel, H; Welink, J; Amidon, G L; Junginger, H E; Midha, K K; Möller, H; Olling, M; Shah, V P; Barends, D M

    2004-08-01

    Literature data related to the Biopharmaceutics Classification System (BCS) are presented on verapamil hydrochloride, propranolol hydrochloride, and atenolol in the form of BCS-monographs. Data on the qualitative composition of immediate release (IR) tablets containing these active substances with a Marketing Authorization (MA) in the Netherlands (NL) are also provided; in view of these MA's the assumption was made that these tablets were bioequivalent to the innovator product. The development of a database with BCS-related data is announced by the International Pharmaceutical Federation (FIP). Copyright 2004 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 93:1945-1956, 2004

  8. Statistical investigation of simulated intestinal fluid composition on the equilibrium solubility of biopharmaceutics classification system class II drugs.

    Science.gov (United States)

    Khadra, Ibrahim; Zhou, Zhou; Dunn, Claire; Wilson, Clive G; Halbert, Gavin

    2015-01-25

    A drug's solubility and dissolution behaviour within the gastrointestinal tract is a key property for successful administration by the oral route and one of the key factors in the biopharmaceutics classification system. This property can be determined by investigating drug solubility in human intestinal fluid (HIF) but this is difficult to obtain and highly variable, which has led to the development of multiple simulated intestinal fluid (SIF) recipes. Using a statistical design of experiment (DoE) technique this paper has investigated the effects and interactions on equilibrium drug solubility of seven typical SIF components (sodium taurocholate, lecithin, sodium phosphate, sodium chloride, pH, pancreatin and sodium oleate) within concentration ranges relevant to human intestinal fluid values. A range of poorly soluble drugs with acidic (naproxen, indomethacin, phenytoin, and piroxicam), basic (aprepitant, carvedilol, zafirlukast, tadalafil) or neutral (fenofibrate, griseofulvin, felodipine and probucol) properties have been investigated. The equilibrium solubility results determined are comparable with literature studies of the drugs in either HIF or SIF indicating that the DoE is operating in the correct space. With the exception of pancreatin, all of the factors individually had a statistically significant influence on equilibrium solubility with variations in magnitude of effect between the acidic and basic or neutral compounds and drug specific interactions were evident. Interestingly for the neutral compounds pH was the factor with the second largest solubility effect. Around one third of all the possible factor combinations showed a significant influence on equilibrium solubility with variations in interaction significance and magnitude of effect between the acidic and basic or neutral compounds. The least number of significant media component interactions were noted for the acidic compounds with three and the greatest for the neutral compounds at seven

  9. Mechanistic Physiologically Based Pharmacokinetic Modeling of the Dissolution and Food Effect of a Biopharmaceutics Classification System IV Compound-The Venetoclax Story.

    Science.gov (United States)

    Emami Riedmaier, Arian; Lindley, David J; Hall, Jeffrey A; Castleberry, Steven; Slade, Russell T; Stuart, Patricia; Carr, Robert A; Borchardt, Thomas B; Bow, Daniel A J; Nijsen, Marjoleen

    2018-01-01

    Venetoclax, a selective B-cell lymphoma-2 inhibitor, is a biopharmaceutics classification system class IV compound. The aim of this study was to develop a physiologically based pharmacokinetic (PBPK) model to mechanistically describe absorption and disposition of an amorphous solid dispersion formulation of venetoclax in humans. A mechanistic PBPK model was developed incorporating measured amorphous solubility, dissolution, metabolism, and plasma protein binding. A middle-out approach was used to define permeability. Model predictions of oral venetoclax pharmacokinetics were verified against clinical studies of fed and fasted healthy volunteers, and clinical drug interaction studies with strong CYP3A inhibitor (ketoconazole) and inducer (rifampicin). Model verification demonstrated accurate prediction of the observed food effect following a low-fat diet. Ratios of predicted versus observed C max and area under the curve of venetoclax were within 0.8- to 1.25-fold of observed ratios for strong CYP3A inhibitor and inducer interactions, indicating that the venetoclax elimination pathway was correctly specified. The verified venetoclax PBPK model is one of the first examples mechanistically capturing absorption, food effect, and exposure of an amorphous solid dispersion formulated compound. This model allows evaluation of untested drug-drug interactions, especially those primarily occurring in the intestine, and paves the way for future modeling of biopharmaceutics classification system IV compounds. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  10. Comparing multilabel classification methods for provisional biopharmaceutics class prediction.

    Science.gov (United States)

    Newby, Danielle; Freitas, Alex A; Ghafourian, Taravat

    2015-01-05

    The biopharmaceutical classification system (BCS) is now well established and utilized for the development and biowaivers of immediate oral dosage forms. The prediction of BCS class can be carried out using multilabel classification. Unlike single label classification, multilabel classification methods predict more than one class label at the same time. This paper compares two multilabel methods, binary relevance and classifier chain, for provisional BCS class prediction. Large data sets of permeability and solubility of drug and drug-like compounds were obtained from the literature and were used to build models using decision trees. The separate permeability and solubility models were validated, and a BCS validation set of 127 compounds where both permeability and solubility were known was used to compare the two aforementioned multilabel classification methods for provisional BCS class prediction. Overall, the results indicate that the classifier chain method, which takes into account label interactions, performed better compared to the binary relevance method. This work offers a comparison of multilabel methods and shows the potential of the classifier chain multilabel method for improved biological property predictions for use in drug discovery and development.

  11. Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches.

    Science.gov (United States)

    Cardot, J-M; Garcia Arieta, A; Paixao, P; Tasevska, I; Davit, B

    2016-07-01

    The US-FDA recently posted a draft guideline for industry recommending procedures necessary to obtain a biowaiver for immediate-release oral dosage forms based on the Biopharmaceutics Classification System (BCS). This review compares the present FDA BCS biowaiver approach, with the existing European Medicines Agency (EMA) approach, with an emphasis on similarities, difficulties, and shared challenges. Some specifics of the current EMA BCS guideline are compared with those in the recently published draft US-FDA BCS guideline. In particular, similarities and differences in the EMA versus US-FDA approaches to establishing drug solubility, permeability, dissolution, and formulation suitability for BCS biowaiver are critically reviewed. Several case studies are presented to illustrate the (i) challenges of applying for BCS biowaivers for global registration in the face of differences in the EMA and US-FDA BCS biowaiver criteria, as well as (ii) challenges inherent in applying for BCS class I or III designation and common to both jurisdictions.

  12. Evaluation of the membrane permeability (PAMPA and skin) of benzimidazoles with potential cannabinoid activity and their relation with the Biopharmaceutics Classification System (BCS).

    Science.gov (United States)

    Alvarez-Figueroa, M Javiera; Pessoa-Mahana, C David; Palavecino-González, M Elisa; Mella-Raipán, Jaime; Espinosa-Bustos, Cristián; Lagos-Muñoz, Manuel E

    2011-06-01

    The permeability of five benzimidazole derivates with potential cannabinoid activity was determined in two models of membranes, parallel artificial membrane permeability assay (PAMPA) and skin, in order to study the relationship of the physicochemical properties of the molecules and characteristics of the membranes with the permeability defined by the Biopharmaceutics Classification System. It was established that the PAMPA intestinal absorption method is a good predictor for classifying these molecules as very permeable, independent of their thermodynamic solubility, if and only if these have a Log P(oct) value <3.0. In contrast, transdermal permeability is conditioned on the solubility of the molecule so that it can only serve as a model for classifying the permeability of molecules that possess high solubility (class I: high solubility, high permeability; class III: high solubility, low permeability).

  13. Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: chloroquine phosphate, chloroquine sulfate, and chloroquine hydrochloride.

    Science.gov (United States)

    Verbeeck, R K; Junginger, H E; Midha, K K; Shah, V P; Barends, D M

    2005-07-01

    Literature data on the properties of chloroquine phosphate, chloroquine sulfate, and chloroquine hydrochloride related to the Biopharmaceutics Classification System (BCS) are reviewed. The available information indicates that these chloroquine salts can be classified as highly soluble and highly permeable, i.e., BCS class I. The qualitative composition of immediate release (IR) tablets containing these Active Pharmaceutical Ingredients (APIs) with a Marketing Authorization (MA) in Belgium (BE), Germany (DE), Finland (FI), and The Netherlands (NL) is provided. In view of these MA's and the critical therapeutic indication of chloroquine, it is assumed that the registration authorities had evidence that these formulations are bioequivalent to the innovator. It is concluded that IR tablets formulated with these excipients are candidates for a biowaiver. (c) 2005 Wiley-Liss, Inc.

  14. Traceability of biopharmaceuticals in spontaneous reporting systems

    DEFF Research Database (Denmark)

    Vermeer, Niels S; Straus, Sabine M J M; Mantel-Teeuwisse, Aukje K

    2013-01-01

    , including spontaneous reporting systems (SRSs), in which reports of ADRs are collected. OBJECTIVE: The aim of this study was to explore the current status of traceability of biopharmaceuticals in the US and the EU up to patient level in SRSs. DESIGN AND SETTING: A cross-sectional study was conducted over......BACKGROUND: Adverse drug reactions (ADRs) of biopharmaceuticals can be batch or product specific, resulting from small differences in the manufacturing process. Detailed exposure information should be readily available in systems for postmarketing safety surveillance of biopharmaceuticals...... the period 2004-2010, including ADR reports from two major SRSs: the FDA Adverse Event Reporting System (FAERS) in the US and EudraVigilance (EV) in the EU. MAIN OUTCOME MEASURES: The availability of batch numbers was determined for biopharmaceuticals, and compared with small molecule drugs...

  15. Biopharmaceutics classification systems for new molecular entities (BCS-NMEs) and marketed drugs (BCS-MD): theoretical basis and practical examples.

    Science.gov (United States)

    Papadopoulou, Vasiliki; Valsami, Georgia; Dokoumetzidis, Aristides; Macheras, Panos

    2008-09-01

    The aim of this work is to develop biopharmaceutics classification systems for new molecular entities (BCS-NMEs) and marketed drugs (BCS-MD). The kinetics of gastrointestinal (GI) wall permeation and dissolution were re-considered theoretically. The relationships between the solubility/dose ratio and the fractions of dose dissolved and absorbed, were also examined. Mean time calculations for drug dissolution (MDT) and permeation (MPT) of the GI wall were analyzed in respect to the mean intestinal transit time (MITT) to identify a cutoff point for drug dissolution and GI wall permeation. Dissolution experiments for marketed drugs were carried out. NMEs were classified into four classes of BCS-NMEs, based on solubility/dose ratio and apparent permeability estimates. A physiologically based cutoff time point for dissolution and permeation was used to differentiate rapidly from slowly dissolving-permeating marketed drugs, which were classified into four classes of BCS-MD using their dissolution index (DI=MITT/MDT) and permeation index (PI=MITT/MPT) values as follows: I (DI>or=3, PI>or=3), II (DIor=3), III (DI>or=3, PI<3) and IV (DI<3, PI<3). In conclusion, two classification systems were developed, one for NMEs based on solubility/dose ratio and permeability estimates and one for marketed drugs based on MDT and MPT estimates.

  16. Preparation, in-vitro and in-vivo evaluation of spray-dried ternary solid dispersion of biopharmaceutics classification system class II model drug.

    Science.gov (United States)

    Paidi, Sharan K; Jena, Sunil K; Ahuja, Bhupesh K; Devasari, Naresh; Suresh, Sarasija

    2015-05-01

    The objective of this study was to investigate the impact of a novel spray-dried ternary solid dispersion (TSD) on the dissolution rate and bioavailability of a biopharmaceutics classification system (BCS) class II model drug, atorvastatin calcium trihydrate (ATC), and evaluate its in-vitro and in-vivo performance. TSD of ATC was prepared by spray-drying method employing ethanol/water solvent systems. The TSD formulations, composed of hydroxypropyl methylcellulose (HPMC E5) and nicotinamide, were optimized by rotatable central composite design. Physicochemical characterization along with dissolution, stability and pharmacokinetic study of optimized TSD was evaluated. The optimized TSD was found to be amorphous with spherical shape morphology. It exhibited a fourfold increase in dissolution rate in comparison to ATC, with a considerable enhancement in oral bioavailability (relative bioavailability of 134.11%). Physicochemical characterization and dissolution study of optimized TSD at the end of stability studies clearly indicated that the stability of optimized TSD was due to hydrogen bonding between drug and HPMC E5 and nicotinamide. This bonding remained unaffected even under stressful conditions of high temperature and humidity. The TSD exhibits a significant increase in dissolution rate, and for this reason should be useful as an efficacious tool to enhance the bioavailability of BCS class II drug molecule, ATC. © 2015 Royal Pharmaceutical Society.

  17. In vitro P-glycoprotein efflux ratio can predict the in vivo brain penetration regardless of biopharmaceutics drug disposition classification system class.

    Science.gov (United States)

    Kikuchi, Ryota; de Morais, Sonia M; Kalvass, J Cory

    2013-12-01

    P-glycoprotein (P-gp) is expressed at the blood-brain barrier (BBB) and restricts the penetration of its substrates into the central nervous system (CNS). In vitro substrate assessment for P-gp is frequently used to predict the in vivo relevance of P-gp-mediated efflux at the BBB. We have conducted a comprehensive review of literature focusing on the in vitro-in vivo correlation of P-gp efflux ratio (ER), and demonstrated that in vitro substrates of P-gp are also in vivo substrates at the BBB. It was of note that the in vitro ER in the MDCK-MDR1 cell line from National Institutes of Health was found to be a better predictor of in vivo ER than that from Netherlands Cancer Institute, with r(2) values of 0.813 and 0.531, respectively. Recently, a research group proposed that 98% of Biopharmaceutics Drug Disposition Classification System (BDDCS) class 1 drugs can penetrate the brain even when those compounds are shown as P-gp substrates in vitro. However, our data analysis suggested that in vitro ER can predict the in vivo brain penetration regardless of the class in BDDCS. Considering that very few marketed CNS drugs are in vivo substrates for P-gp, the in vitro substrate assessment of P-gp should be used in the early stages of drug discovery to select compounds that are most likely to penetrate the CNS to exert their pharmacologic action.

  18. Species differences in the dissolution and absorption of griseofulvin and albendazole, biopharmaceutics classification system class II drugs, in the gastrointestinal tract.

    Science.gov (United States)

    Tanaka, Yusuke; Waki, Ryoichi; Nagata, Shunji

    2013-01-01

    It is well known that large differences exist in the bioavailability of orally administered drugs between species. Dissolution is the first step in the oral absorption of solid drugs. In this study, we measured the in vivo luminal concentrations of griseofulvin (GF) and albendazole (AZ), Biopharmaceutics Classification System (BCS) class II drugs, and the GF fraction absorbed (Fa) in rats. Then, we compared the GF Fa in rat with that in other species reported previously to evaluate differences in drug dissolution and oral absorption. The Fa of GF has been reported to decrease from 80% to 40% with an increase in the oral dose in dogs and humans, because the rate-limiting step for absorption shifts from dissolution to solubility. However, such non-linearity was not observed in rats that were administered doses in the same ranges as those in humans, and the Fa values in rats were higher than those in dogs or humans. The in vivo luminal concentration of GF after oral administration in rats was much higher than the saturated solubility of GF in fasted-state simulated dog (FaSSIF(dog)) or human intestinal fluid (FaSSIF(human)). Furthermore, oral administration of AZ showed similar tendencies of interspecies differences in dissolution and oral absorption.

  19. A perspective for biowaivers of human bioequivalence studies on the basis of the combination of the ratio of AUC to the dose and the biopharmaceutics classification system.

    Science.gov (United States)

    Sakuma, Shinji; Tachiki, Hidehisa; Uchiyama, Hitoshi; Fukui, Yasunobu; Takeuchi, Naohiro; Kumamoto, Kazuo; Satoh, Tomonori; Yamamoto, Yoshinobu; Ishii, Emi; Sakai, Yoshiyuki; Takeuchi, Susumu; Sugita, Masaru; Yamashita, Shinji

    2011-08-01

    The ratio of AUC to the dose (AUC/dose) was previously found as a parameter that predicts a risk of bioinequivalence of oral drug products. On the basis of the combination of this parameter and the biopharmaceutics classification system (BCS), a perspective for biowaivers of human bioequivalence studies is discussed. Databases of bioequivalence studies using immediate-release solid oral dosage forms were disclosed by 6 Japanese generic pharmaceutical companies, and the number of subjects required for demonstrating bioequivalence between generic and reference products was plotted as a function of AUC/dose for each BCS category. A small variation in the number of subjects was constantly observed in bioequivalence studies using dosage forms containing an identical BCS class 1 or class 3 drug, even though formulations of the generic product differ between companies. The variation was extremely enlarged when the drugs were substituted with BCS class 2 drugs. Rate-determining steps in oral absorption of highly water-soluble BCS class 1 and class 3 drugs are independent of formulations when there is no significant difference in the in vitro dissolution profiles between formulations. The small variation observed for both BCS categories indicates that the number of subjects converges into one value for each drug. Our analysis indicates the appropriateness of biowaiver of bioequivalence studies for immediate-release solid oral dosage forms containing not only BCS class 1 drugs but also class 3 drugs.

  20. Use of the Biopharmaceutics Drug Disposition Classification System (BDDCS) to Help Predict the Occurrence of Idiosyncratic Cutaneous Adverse Drug Reactions Associated with Antiepileptic Drug Usage.

    Science.gov (United States)

    Chan, Rosa; Wei, Chun-Yu; Chen, Yuan-Tsong; Benet, Leslie Z

    2016-05-01

    Cutaneous adverse reactions (CARs) from antiepileptic drugs (AEDs) are common, ranging from mild to life-threatening, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The identification of subjects carrying the HLA-B*15:02, an inherited allelic variant of the HLA-B gene, and the avoidance of carbamazepine (CBZ) therapy in these subjects are strongly associated with a decrease in the incidence of carbamazepine-induced SJS/TEN. In spite of the strong genetic associations, the initiation of hypersensitivity for AEDs is still not very well characterized. Predicting the potential for other AEDs to cause adverse reactions will be undoubtedly beneficial to avoid CARs, which is the focus of this report. Here, we explore the use of the Biopharmaceutics Drug Disposition Classification System (BDDCS) to distinguish AEDs associated with and without CARs by examining the binding relationship of AEDs to HLA-B*15:02 and data from extensive reviews of medical records. We also evaluate the lack of benefit from a Hong Kong population policy on the effects of screening for HLA-B*15:02 and previous incorrect structure-activity hypotheses. Our analysis concludes that BDDCS class 2 AEDs are more prone to cause adverse cutaneous reactions than certain BDDCS class 1 AEDs and that BDDCS Class 3 drugs have the lowest levels of cutaneous adverse reactions. We propose that BDDCS Class 3 AEDs should be preferentially used for patients with Asian backgrounds (i.e., Han Chinese, Thai, and Malaysian populations) if possible and in patients predisposed to skin rashes.

  1. Evaluation of changes in oral drug absorption in preterm and term neonates for Biopharmaceutics Classification System (BCS) class I and II compounds.

    Science.gov (United States)

    Somani, Amit A; Thelen, Kirstin; Zheng, Songmao; Trame, Mirjam N; Coboeken, Katrin; Meyer, Michaela; Schnizler, Katrin; Ince, Ibrahim; Willmann, Stefan; Schmidt, Stephan

    2016-01-01

    Evidence suggests that the rate of oral drug absorption changes during early childhood. Yet, respective clinical implications are currently unclear, particularly for preterm neonates. The objective of this study was to evaluate changes in oral drug absorption after birth for different Biopharmaceutics Classification System (BCS) class I and II compounds to better understand respective implications for paediatric pharmacotherapy. Two paradigm compounds were selected for BCS class I (paracetamol (acetaminophen) and theophylline) and II (indomethacin and ibuprofen), respectively, based on the availability of clinical literature data following intravenous and oral dosing. A comparative population pharmacokinetic analysis was performed in a step-wise manner in NONMEM® 7.2 to characterize and predict changes in oral drug absorption after birth for paracetamol, theophylline and indomethacin. A one compartment model with an age-dependent maturation function for oral drug absorption was found appropriate to characterize the pharmacokinetics of paracetamol. Our findings indicate that the rate at which a drug is absorbed from the GI tract reaches adult levels within about 1 week after birth. The maturation function for paracetamol was found applicable to theophylline and indomethacin once solubility limitations were overcome via drug formulation. The influence of excipients on solubility and, hence, oral bioavailability was confirmed for ibuprofen, a second BCS class II compound. The findings of our study suggest that the processes underlying changes in oral drug absorption after birth are drug-independent and that the maturation function identified for paracetamol may be generally applicable to other BCS class I and II compounds for characterizing drug absorption in preterm as well as term neonates. © 2015 The British Pharmacological Society.

  2. Risk assessment for extending the Biopharmaceutics Classification System-based biowaiver of immediate release dosage forms of fluconazole in adults to the paediatric population.

    Science.gov (United States)

    Charoo, Naseem A; Cristofoletti, Rodrigo; Dressman, Jennifer B

    2015-08-01

    The paediatric population undergoes developmental changes in gastric pH, gastric emptying, intestinal transit time, membrane permeability, protein binding, body water, distribution and metabolism. It is widely recognised that changes in these parameters may result in an alteration of the plasma profile and thus in key bioequivalence parameters such as Cmax (maximum plasma concentration of drug) and area under the plasma concentration vs time profile curve. The aim of this work is to assess the risk of extending the biowaiver for immediate release dosage formulations of fluconazole from the adult to the paediatric population. Fluconazole exhibits good solubility and very rapid dissolution characteristics in various pH media. The absorption of fluconazole in children is known to be complete (over 90%) and not impaired by elevated pH, which is prevalent during the early days of life. Dose numbers calculated using body surface area are less than 1. Therefore, the risk to drug absorption due to differences in gastric pH, gastric emptying, intestinal transit, membrane permeability and metabolising enzymes between adults and children is considered low. Thus, it can be safely concluded that fluconazole meets highly soluble and highly permeable criteria in the paediatric population and can be allocated to class 1 of the Biopharmaceutics Classification System (BCS) for this population as well as in adults. Additionally, fluconazole has an excellent safety profile in children, similar to that in adults. The BCS-based biowaiver claimed in adults can be safely extended to the paediatric population provided that the requirements in excipient selection and dissolution profile comparison using BCS-based dissolution conditions as stated in the biowaiver monograph for fluconazole immediate release dosage forms in adults are fulfilled. © 2015 Royal Pharmaceutical Society.

  3. Biopharmaceutics classification and intestinal absorption study of apigenin.

    Science.gov (United States)

    Zhang, Jianjun; Liu, Dapeng; Huang, Yanting; Gao, Yuan; Qian, Shuai

    2012-10-15

    The aim of the study was to characterize the biopharmaceutics classification system (BCS) category of apigenin (AP) using intrinsic dissolution rate (IDR) and rat intestinal permeability, and to investigate the intestinal absorption mechanism of AP in rats. In the present investigation, equilibrium solubility and intrinsic dissolution rate (IDR) of AP were estimated in phosphate buffers. Effective intestinal permeability (P(eff)) of AP was determined using single-pass intestinal perfusion (SPIP) technique in four segments (duodenum, jejunum, ileum and colon) of rat intestine at three concentrations (10, 50 and 100 μg/ml). The aqueous solubility of AP in tested phosphate buffers was very poor with maximum solubility of 2.16 μg/ml at pH 7.5. The IDR of AP was very low with a value of 0.006 mg/min/cm(2). The minimum and maximum P(eff)s determined by SPIP were 0.198×10(-4) and 0.713×10(-4) cm/s at jejunum and duodenum site, respectively. In addition, the concentration-dependent permeability behavior was observed in the duodenum and jejunum, which suggested that AP was transported by both passive and active carrier-mediated saturable mechanism in these two intestinal segments. However, the observed concentration-independent permeability behavior in ileum and colon indicated primarily passive transport mechanism of absorption of AP in the last two intestinal segments. AP was classified as class II drug of the BCS due to its low solubility and high intestinal permeability. AP could be well absorbed in the whole intestine with the main absorption site at duodenum. The absorption of AP in four intestinal segments exhibited different transport mechanisms. Copyright © 2012 Elsevier B.V. All rights reserved.

  4. Acute toxicities of pharmaceuticals toward green algae. mode of action, biopharmaceutical drug disposition classification system and quantile regression models.

    Science.gov (United States)

    Villain, Jonathan; Minguez, Laetitia; Halm-Lemeille, Marie-Pierre; Durrieu, Gilles; Bureau, Ronan

    2016-02-01

    The acute toxicities of 36 pharmaceuticals towards green algae were estimated from a set of quantile regression models representing the first global quantitative structure-activity relationships. The selection of these pharmaceuticals was based on their predicted environmental concentrations. An agreement between the estimated values and the observed acute toxicity values was found for several families of pharmaceuticals, in particular, for antidepressants. A recent classification (BDDCS) of drugs based on ADME properties (Absorption, Distribution, Metabolism and Excretion) was clearly correlated with the acute ecotoxicities towards algae. Over-estimation of toxicity from our QSAR models was observed for classes 2, 3 and 4 whereas our model results were in agreement for the class 1 pharmaceuticals. Clarithromycin, a class 3 antibiotic characterized by weak metabolism and high solubility, was the most toxic to algae (molecular stability and presence in surface water). Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Effects of Uremic Toxins on Transport and Metabolism of Different Biopharmaceutics Drug Disposition Classification System (BDDCS) Xenobiotics

    Science.gov (United States)

    Reyes, Maribel; Benet, Leslie Z.

    2013-01-01

    Chronic kidney disease (CKD) is recognized to cause pharmacokinetic changes in renally excreted drugs; however, pharmacokinetic changes are also reported for drugs that are non-renally eliminated. Few studies have investigated how uremic toxins may affect drug transporters and metabolizing enzymes and how these may result in pharmacokinetic/metabolic changes in CKD. Here, we investigated the effects of uremic toxins and human uremic serum on the transport of the prototypical transporter substrate [3H]-estrone sulfate and three BDDCS drugs, propranolol, losartan, and eprosartan. We observed a significant decrease in [3H]-estrone sulfate, losartan, and eprosartan uptake with some uremic toxins in both transfected cells and rat hepatocytes. The uptake of losartan was decreased in rat and human hepatocytes (28%, and 48% respectively) in the presence of hemodialysis (HD) serum. Time-course studies of losartan showed a 27%, 65% and 68% increase in AUC in the presence of HD serum, rifampin, and sulfaphenazole respectively. Intracellular losartan AUC decreased significantly in the treatment groups and the metabolite AUC decreased by 41% and 26% in rifampin and sulfaphenazole treated group. The intracellular AUC of eprosartan increased 190% in the presence of HD serum. These studies indicate that the uremic toxins contained in HD serum play an important role in drug disposition through drug transporters, and that there would be differential effects depending on the BDDCS classification of the drug. PMID:21618544

  6. Biopharmaceuticals as Challenges to the Regulatory System

    NARCIS (Netherlands)

    Ebbers, H.C.

    2012-01-01

    Biopharmaceuticals differ from small molecules in terms of structure and pharmacology. Furthermore, they are also prescribed for different patient populations. The protein nature of biopharmaceuticals makes them especially prone for immunological reactions and their safety profile may be affected by

  7. Study on Biopharmaceutics Classification and Oral Bioavailability of a Novel Multikinase Inhibitor NCE for Cancer Therapy

    Directory of Open Access Journals (Sweden)

    Yang Yang

    2014-04-01

    Full Text Available Specific biopharmaceutics classification investigation and study on phamacokinetic profile of a novel drug candidate (2-methylcarbamoyl-4-{4-[3- (trifluoromethyl benzamido] phenoxy} pyridinium 4-methylbenzenesulfonate monohydrate, NCE were carried out. Equilibrium solubility and intrinsic dissolution rate (IDR of NCE were estimated in different phosphate buffers. Effective intestinal permeability (Peff of NCE was determined using single-pass intestinal perfusion technique in rat duodenum, jejunum and ileum at three concentrations. Theophylline (high permeability and ranitidine (low permeability were also applied to access the permeability of NCE as reference compounds. The bioavailability after intragastrical and intravenous administration was measured in beagle dogs. The solubility of NCE in tested phosphate buffers was quite low with the maximum solubility of 81.73 μg/mL at pH 1.0. The intrinsic dissolution ratio of NCE was 1 × 10−4 mg·min−1·cm−2. The Peff value of NCE in all intestinal segments was more proximate to the high-permeability reference theophylline. Therefore, NCE was classified as class II drug according to Biopharmaceutics Classification System due to its low solubility and high intestinal permeability. In addition, concentration-dependent permeability was not observed in all the segments, indicating that there might be passive transportation for NCE. The absolute oral bioavailability of NCE in beagle dogs was 26.75%. Therefore, dissolution promotion will be crucial for oral formulation development and intravenous administration route will also be suggested for further NCE formulation development. All the data would provide a reference for biopharmaceutics classification research of other novel drug candidates.

  8. Study on biopharmaceutics classification and oral bioavailability of a novel multikinase inhibitor NCE for cancer therapy.

    Science.gov (United States)

    Yang, Yang; Fan, Chun-Mei; He, Xuan; Ren, Ke; Zhang, Jin-Kun; He, Ying-Ju; Yu, Luo-Ting; Zhao, Ying-Lan; Gong, Chang-Yang; Zheng, Yu; Song, Xiang-Rong; Zeng, Jun

    2014-04-25

    Specific biopharmaceutics classification investigation and study on phamacokinetic profile of a novel drug candidate (2-methylcarbamoyl-4-{4-[3- (trifluoromethyl) benzamido] phenoxy} pyridinium 4-methylbenzenesulfonate monohydrate, NCE) were carried out. Equilibrium solubility and intrinsic dissolution rate (IDR) of NCE were estimated in different phosphate buffers. Effective intestinal permeability (P(eff)) of NCE was determined using single-pass intestinal perfusion technique in rat duodenum, jejunum and ileum at three concentrations. Theophylline (high permeability) and ranitidine (low permeability) were also applied to access the permeability of NCE as reference compounds. The bioavailability after intragastrical and intravenous administration was measured in beagle dogs. The solubility of NCE in tested phosphate buffers was quite low with the maximum solubility of 81.73 μg/mL at pH 1.0. The intrinsic dissolution ratio of NCE was 1 × 10⁻⁴ mg·min⁻¹·cm⁻². The P(eff) value of NCE in all intestinal segments was more proximate to the high-permeability reference theophylline. Therefore, NCE was classified as class II drug according to Biopharmaceutics Classification System due to its low solubility and high intestinal permeability. In addition, concentration-dependent permeability was not observed in all the segments, indicating that there might be passive transportation for NCE. The absolute oral bioavailability of NCE in beagle dogs was 26.75%. Therefore, dissolution promotion will be crucial for oral formulation development and intravenous administration route will also be suggested for further NCE formulation development. All the data would provide a reference for biopharmaceutics classification research of other novel drug candidates.

  9. Provisional in-silico biopharmaceutics classification (BCS) to guide oral drug product development.

    Science.gov (United States)

    Wolk, Omri; Agbaria, Riad; Dahan, Arik

    2014-01-01

    The main objective of this work was to investigate in-silico predictions of physicochemical properties, in order to guide oral drug development by provisional biopharmaceutics classification system (BCS). Four in-silico methods were used to estimate LogP: group contribution (CLogP) using two different software programs, atom contribution (ALogP), and element contribution (KLogP). The correlations (r(2)) of CLogP, ALogP and KLogP versus measured LogP data were 0.97, 0.82, and 0.71, respectively. The classification of drugs with reported intestinal permeability in humans was correct for 64.3%-72.4% of the 29 drugs on the dataset, and for 81.82%-90.91% of the 22 drugs that are passively absorbed using the different in-silico algorithms. Similar permeability classification was obtained with the various in-silico methods. The in-silico calculations, along with experimental melting points, were then incorporated into a thermodynamic equation for solubility estimations that largely matched the reference solubility values. It was revealed that the effect of melting point on the solubility is minor compared to the partition coefficient, and an average melting point (162.7 °C) could replace the experimental values, with similar results. The in-silico methods classified 20.76% (± 3.07%) as Class 1, 41.51% (± 3.32%) as Class 2, 30.49% (± 4.47%) as Class 3, and 6.27% (± 4.39%) as Class 4. In conclusion, in-silico methods can be used for BCS classification of drugs in early development, from merely their molecular formula and without foreknowledge of their chemical structure, which will allow for the improved selection, engineering, and developability of candidates. These in-silico methods could enhance success rates, reduce costs, and accelerate oral drug products development.

  10. Biopharmaceutical Innovation System in China: System Evolution and Policy Transitions (Pre-1990s-2010s)

    Science.gov (United States)

    Hu, Hao; Chung, Chao-Chen

    2015-01-01

    Background: This article sets up the initial discussion of the evolution of biopharmaceutical innovation in China through the perspective of sectoral innovation system (SIS). Methods: Two data sources including archival documentary data and field interviews were used in this study. Archival documentary data was collected from China Food and Drug Administration (CFDA) and Chinese National Knowledge Infrastructure (CNKI). In addition, industrial practitioners and leading researchers in academia were interviewed. Results: Biopharmaceutical in China was established through international knowledge transfer. The firms played more active role in commercializing biopharmaceutical in China though universities and research institutes were starting to interact with local firms and make contribution to biopharmaceutical industrialization. The transition of the Chinese government’s policies continuously shapes the evolution of biopharmaceutical sector. Policies have been dramatic changes before and after 1980s to encourage developing biopharmaceutical as a competitive industry for China. Conclusion: A SIS for biopharmaceutical has been shaped in China. However, currently biopharmaceutical is still a small sector in China, and for the further growth of the industry more synthetic policies should be implemented. Not only the policy supports towards the research and innovation of biopharmaceuticals in the early stage of development should be attended, but also commercialization of biopharmaceutical products in the later stage of sales. PMID:26673466

  11. pH-Dependent solubility and permeability criteria for provisional biopharmaceutics classification (BCS and BDDCS) in early drug discovery.

    Science.gov (United States)

    Varma, Manthena V; Gardner, Iain; Steyn, Stefanus J; Nkansah, Paul; Rotter, Charles J; Whitney-Pickett, Carrie; Zhang, Hui; Di, Li; Cram, Michael; Fenner, Katherine S; El-Kattan, Ayman F

    2012-05-07

    The Biopharmaceutics Classification System (BCS) is a scientific framework that provides a basis for predicting the oral absorption of drugs. These concepts have been extended in the Biopharmaceutics Drug Disposition Classification System (BDDCS) to explain the potential mechanism of drug clearance and understand the effects of uptake and efflux transporters on absorption, distribution, metabolism, and elimination. The objective of present work is to establish criteria for provisional biopharmaceutics classification using pH-dependent passive permeability and aqueous solubility data generated from high throughput screening methodologies in drug discovery settings. The apparent permeability across monolayers of clonal cell line of Madin-Darby canine kidney cells, selected for low endogenous efflux transporter expression, was measured for a set of 105 drugs, with known BCS and BDDCS class. The permeability at apical pH 6.5 for acidic drugs and at pH 7.4 for nonacidic drugs showed a good correlation with the fraction absorbed in human (Fa). Receiver operating characteristic (ROC) curve analysis was utilized to define the permeability class boundary. At permeability ≥ 5 × 10(-6) cm/s, the accuracy of predicting Fa of ≥ 0.90 was 87%. Also, this cutoff showed more than 80% sensitivity and specificity in predicting the literature permeability classes (BCS), and the metabolism classes (BDDCS). The equilibrium solubility of a subset of 49 drugs was measured in pH 1.2 medium, pH 6.5 phosphate buffer, and in FaSSIF medium (pH 6.5). Although dose was not considered, good concordance of the measured solubility with BCS and BDDCS solubility class was achieved, when solubility at pH 1.2 was used for acidic compounds and FaSSIF solubility was used for basic, neutral, and zwitterionic compounds. Using a cutoff of 200 μg/mL, the data set suggested a 93% sensitivity and 86% specificity in predicting both the BCS and BDDCS solubility classes. In conclusion, this study identified

  12. [Biopharmaceutics classification and absorption mechanisms primary study on four kinds of flavonoids].

    Science.gov (United States)

    Li, Hui-Fang; Zhang, Dong; Qu, Wen-Jun; Wang, Hai-Lin; Liu, Yang; Borjigdai, Almaz; Cui, Jian; Dong, Zheng-Qi

    2016-04-01

    The solubility and permeability on four kinds of flavonoids (kaempferol, hesperidin, apigenin, genistein) were test according to the theory of biopharmaceutics classification system (BCS), and their absorption mechanism. The solubility was investigated by the method in determination of solubility of "Chinese Pharmacopoeia 2010". To detect appearance permeability of compounds mentioned above, the appropriate concentrations were selected by the MTT method in cell transfer experiments in Caco-2 cell model, which established by in vitro cell culture method. Therefore, these compounds were classified with BCS according to solubility and permeability. In addition, to explore absorption mechanisms, the experiments in three different concentrations of compounds in high, medium and low in bidirectional transformation methods in Caco-2 cell model contacted. The study indicated that all of kaempferol, hesperidin, apigenin, genistein have the characteristics in low solubility and high permeability, which belong to BCSⅡ, and the absorption mechanism of kaempferol was active transportation. Whereas, hesperidin, apigenin, genistein were passive transportation. In this study, it carried out initial explorations on establishment of determination for solubility and permeability in flavonoids, and provided theoretical reference for further research on BCS in traditional Chinese medicine. Copyright© by the Chinese Pharmaceutical Association.

  13. Biopharmaceutics classification of selected beta-blockers: solubility and permeability class membership.

    Science.gov (United States)

    Yang, Yongsheng; Faustino, Patrick J; Volpe, Donna A; Ellison, Christopher D; Lyon, Robbe C; Yu, Lawrence X

    2007-01-01

    The purpose of this study was to determine the permeability and solubility of seven beta-blockers (acebutolol, atenolol, labetalol, metoprolol, nadolol, sotalol, and timolol) and to classify them according to the Biopharmaceutics Classification System (BCS). Apparent permeability coefficients (Papp) were measured using the Caco-2 cell line, and the solubility was determined at 37 degrees C over a pH range of 1.0-7.5. The permeability coefficients ranged from 1.0x10(-7) to 4.8x10(-5) cm/s. On the basis of the in vitro permeability and solubility data observed in the study, labetolol, metoprolol, and timolol can be categorized as BCS Class I drugs, whereas acebutolol, atenolol, and nadolol belong to BCS Class III. The permeability coefficients in Caco-2 cells were consistent with the reported extent of intestinal absorption in humans for all drugs except sotalol. Sotalol displayed low permeability in the Caco-2 cell line, but the extent of intestinal absorption in humans is over 90%. The low permeability through the Caco-2 monolayers might be largely related to its low lipophilicity. In addition, the difference between the tightness of the intercellular junction in vivo and in vitro may partially contribute to this disparity in the sotalol permeability of in vivo and in vitro.

  14. Computational models to assign biopharmaceutics drug disposition classification from molecular structure.

    Science.gov (United States)

    Khandelwal, Akash; Bahadduri, Praveen M; Chang, Cheng; Polli, James E; Swaan, Peter W; Ekins, Sean

    2007-12-01

    We applied in silico methods to automatically classify drugs according to the Biopharmaceutics Drug Disposition Classification System (BDDCS). Models were developed using machine learning methods including recursive partitioning (RP), random forest (RF) and support vector machine (SVM) algorithms with ChemDraw, clogP, polar surface area, VolSurf and MolConnZ descriptors. The dataset consisted of 165 training and 56 test set molecules. RF model 3, RP model 1, and SVM model 1 can correctly predict 73.1, 63.6 and 78.6% test compounds in classes 1, 2 and 3, respectively. Both RP and SVM models can be used for class 4 prediction. The inclusion of consensus analysis resulted in improved test set predictions for class 2 and 4 drugs. The models can be used to predict BDDCS class for new compounds from molecular structure using readily available molecular descriptors and software, representing an area where in silico approaches could aid the pharmaceutical industry in speeding drugs to the patient and reducing costs. This could have significant applications in drug discovery to identify molecules that may have future developability issues.

  15. Biopharmaceutics classification of puerarin and comparison of perfusion approaches in rats.

    Science.gov (United States)

    Li, Hewei; Dong, Ling; Liu, Yang; Wang, Guopeng; Wang, Gang; Qiao, Yanjiang

    2014-05-15

    The present study was conducted to characterize the biopharmaceutics classification system (BCS) category of puerarin in terms of intrinsic dissolution rate (IDR) and rat intestinal permeability and to investigate the poor intestinal absorption probably related to the drug metabolism in the gut wall of rats. Equilibrium solubility of puerarin was determined in various phosphate buffers and water, and IDR was estimated by measuring the dissolution of a non-disintegrating compact. Intestinal permeability (Peff and Pblood) of puerarin was determined using the technology of in situ single-pass intestinal perfusion (SPIP) and intestinal perfusion with venous sampling (IPVS) in fasted rats. Metabolism of puerarin in intestinal tissue was tested by S9 incubation in vitro. The aqueous solubility of puerarin in phosphate buffers and water was good with a maximum solubility of 7.56 mg/mL at pH 7.4. Obtained IDR values of puerarin were in the range of 0.360-1.088 mg/min/cm(2), with maximum and minimum IDR value of pH 7.4 and pH 4.0, respectively. The Peff was 1.252 × 10(-5)cm/s determined by SPIP and the Pblood was 0.068×10(-5)cm/s by IPVS in jejunum at puerarin 80 μg/mL. The metabolism rate of puerarin determined by the intestinal S9 fraction indicated that the gut wall metabolism of puerarin is one cause of poor absorption. According to the proposed classification of drugs and the results obtained from equilibrium solubility, IDR, Peff and Pblood, it is concluded that puerarin could be categorized IV drug of the BCS based on its low solubility and low intestinal permeability values. Copyright © 2014 Elsevier B.V. All rights reserved.

  16. Intestinal permeability study of minoxidil: assessment of minoxidil as a high permeability reference drug for biopharmaceutics classification.

    Science.gov (United States)

    Ozawa, Makoto; Tsume, Yasuhiro; Zur, Moran; Dahan, Arik; Amidon, Gordon L

    2015-01-05

    The purpose of this study was to evaluate minoxidil as a high permeability reference drug for Biopharmaceutics Classification System (BCS). The permeability of minoxidil was determined in in situ intestinal perfusion studies in rodents and permeability studies across Caco-2 cell monolayers. The permeability of minoxidil was compared with that of metoprolol, an FDA reference drug for BCS classification. In rat perfusion studies, the permeability of minoxidil was somewhat higher than that of metoprolol in the jejunum, while minoxidil showed lower permeability than metoprolol in the ileum. The permeability of minoxidil was independent of intestinal segment, while the permeability of metoprolol was region-dependent. Similarly, in mouse perfusion study, the jejunal permeability of minoxidil was 2.5-fold higher than that of metoprolol. Minoxidil and metoprolol showed similar permeability in Caco-2 study at apical pH of 6.5 and basolateral pH of 7.4. The permeability of minoxidil was independent of pH, while metoprolol showed pH-dependent transport in Caco-2 study. Minoxidil exhibited similar permeability in the absorptive direction (AP-BL) in comparison with secretory direction (BL-AP), while metoprolol had higher efflux ratio (ER > 2) at apical pH of 6.5 and basolateral pH of 7.4. No concentration-dependent transport was observed for either minoxidil or metoprolol transport in Caco-2 study. Verapamil did not alter the transport of either compounds across Caco-2 cell monolayers. The permeability of minoxidil was independent of both pH and intestinal segment in intestinal perfusion studies and Caco-2 studies. Caco-2 studies also showed no involvement of carrier mediated transport in the absorption process of minoxidil. These results suggest that minoxidil may be an acceptable reference drug for BCS high permeability classification. However, minoxidil exhibited higher jejunal permeability than metoprolol and thus to use minoxidil as a reference drug would raise the

  17. Biopharmaceutics permeability classification of lorcaserin, a selective 5-hydroxytryptamine 2C agonist: method suitability and permeability class membership.

    Science.gov (United States)

    Chen, Chuan; Ma, Michael G; Fullenwider, Cody L; Chen, Weichao G; Sadeque, Abu J M

    2013-12-02

    The objectives of the study were (1) to demonstrate that a Caco-2 cell-based permeability assay, developed in our laboratory, is suitable to identify the permeability classification according to the US Food and Drug Administration Biopharmaceutics Classification System guidance, and (2) to use the validated Caco-2 method to determine permeability class membership of lorcaserin. Lorcaserin, marketed in United States as Belviq, is a selective human 5-hydroxytryptamine 2C agonist used for weight management. First, the permeability of twenty commercially available drugs was determined in the apical-to-basolateral direction at a final concentration of 10 μM, with the pH of transporter buffer in the apical and basolateral compartments being 6.8 and 7.4, respectively. A rank-order relationship between in vitro permeability results and the extent of human intestinal absorption for the drugs tested was observed. Second, the apparent permeability coefficient values of lorcaserin at 2, 20, and 200 μM and apical pH values of 6.8 and 7.4 in the apical-to-basolateral direction were determined using the validated method and found to be comparable to those of the high-permeability internal standard metoprolol. Lorcaserin permeability across Caco-2 cell monolayers was not dependent on the variation of apical pH. Furthermore, lorcaserin was not a substrate for efflux transporters such as P-glycoprotein. In conclusion, using the validated Caco-2 permeability assay, it was shown that lorcaserin is a highly permeable compound.

  18. Novel cationic supersaturable nanomicellar systems of raloxifene hydrochloride with enhanced biopharmaceutical attributes.

    Science.gov (United States)

    Jain, Atul; Kaur, Rajpreet; Beg, Sarwar; Kushwah, Varun; Jain, Sanyog; Singh, Bhupinder

    2018-03-27

    The work describes systematic development of nanomicellar cationic supersaturable self-nanoemulsifying drug delivery systems (CS-SNEDDS) for augmenting oral biopharmaceutical performance of raloxifene hydrochloride. Plain SNEDDS formulation containing Capryol 90, Cremophor RH 40, and Transcutol HP was optimized using D-optimal mixture design. SNEDDS were characterized for emulsification time, globule size, in vitro drug release, and ex vivo permeation. The CS-SNEDDS formulation was prepared from the optimized SNEDDS by adding oleylamine as the cationic charge inducer and HPMC as the polymeric precipitation inhibitor. Evaluation of CS-SNEDDS was carried out through in vitro cell line studies on Caco-2 and MCF-7 cells, in situ perfusion, and in vivo pharmacokinetic studies, which indicated significant improvement in biopharmaceutical attributes of the drug from CS-SNEDDS over plain drug.

  19. Biopharmaceutical Classification System in Invitro/ In-vivo Correlation

    African Journals Online (AJOL)

    Drug development is a very laborious and expensive process. One of the major reasons for failure during the clinical phases of drug development is inadequate pharmacokinetic data on the drug candidate. Therefore, it would be advantageous if the pharmacokinetic properties of drug candidates be predicted beforehand.

  20. Evaluation of the use of partition coefficients and molecular surface properties as predictors of drug absorption: a provisional biopharmaceutical classification of the list of national essential medi

    Directory of Open Access Journals (Sweden)

    NU Rahman

    2011-05-01

    Full Text Available Background and the purpose of the study: Partition coefficients (log D and log P and molecular surface area (PSA are potential predictors of the intestinal permeability of drugs. The aim of this investigation was to evaluate and compare these intestinal permeability indicators.   Methods: Aqueous solubility data were obtained from literature or calculated using ACD/Labs and ALOGPS. Permeability data were predicted based on log P, log D at pH 6.0 (log D6.0, and PSA.  Results: Metoprolol's log P, log D6.0 and a PSA of <65 Å correctly predicted 55.9%, 50.8% and 54.2% of permeability classes, respectively. Labetalol's log P, log D6.0, and PSA correctly predicted 54.2%, 64.4% and 61% of permeability classes, respectively. Log D6.0 correlated well (81% with Caco-2 permeability (Papp. Of the list of national essential medicines, 135 orally administered drugs were classified into biopharmaceutical classification system (BCS. Of these, 57 (42.2%, 28 (20.7%, 44 (32.6%, and 6 (4.4% were class I, II, III and IV respectively. Conclusion: Log D6.0 showed better prediction capability than log P. Metoprolol as permeability internal standard was more conservative than labetalol.

  1. N-glycosylation engineering of biopharmaceutical expression systems.

    Science.gov (United States)

    Jacobs, P P; Callewaert, N

    2009-09-01

    N-glycosylation, the enzymatic coupling of oligosaccharides to specific asparagine residues of nascent polypeptide chains, is one of the most widespread post-translational modifications. Following transfer of an N-glycan precursor in the ER, this structure is further modified by a number of glycosidases and glyco-syltransferases in the ER and the Golgi complex. The processing reactions occurring in the ER are highly conserved between lower and higher eukaryotes. In contrast, the reactions that take place in the Golgi complex are species- and cell type-specific. Due to its non-template driven nature, glycoproteins typically occur as a mixture of glycoforms. Since N-glycans influence circulation half-life, tissue distribution, and biological activity each glycoform has its own pharmacokinetic, pharmacodynamic and efficacy profile. Moreover, modification of glycoproteins with non-human oligosaccharides can result in undesired immunogenicity. Therefore, engineering of the N-glycosylation pathway of most currently used heterologous protein expression systems (bacteria, mammalian cells, insect cells, yeasts and plants) is actively pursued by several academic and industrial laboratories. These research efforts are in the first place directed at humanizing the N-glycosylation pathway and eliminating immunogenic glycotopes. Moreover, one wants to establish new structure-function relationships of different glycoforms, which helps to decreasing the complexity of the N-glycan repertoire towards one defined N-glycan structure. In this review, we discuss the most important recent milestones in the glycoengineering field.

  2. Characterization of systems with amino-acids and oligosaccharides as modifiers of biopharmaceutical properties of furosemide.

    Science.gov (United States)

    Miranda, Julieta Abraham; Garnero, Claudia; Zoppi, Ariana; Sterren, Vanesa; Ayala, Alejandro P; Longhi, Marcela R

    2018-02-05

    Furosemide is the most commonly prescribed diuretic drug in spite of its suboptimal biopharmaceutical properties. In this work, the addition of different amino-acids was studied with the aim of selecting an enhancer of the furosemide solubility. The best results were obtained with arginine. Also, binary (furosemide:arginine) and ternary (furosemide:arginine:β-cyclodextrin and furosemide:arginine:maltodextrin) systems were prepared by the kneading method and they were compared with their corresponding physical mixtures. These new systems were characterized by Fourier transform infrared and Raman spectroscopy, X-ray powder diffractometry, scanning electron microscopy, thermogravimetric analysis, and differential scanning calorimetry. In addition, dissolution studies were performed in simulated gastric fluid. The best results in relation to improving biopharmaceutical properties were obtained with a binary combination of furosemide and arginine, demonstrating that this system could result in a suitable candidate for the development of a promising pharmaceutical formulation of the drug. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Ontologies vs. Classification Systems

    DEFF Research Database (Denmark)

    Madsen, Bodil Nistrup; Erdman Thomsen, Hanne

    2009-01-01

    What is an ontology compared to a classification system? Is a taxonomy a kind of classification system or a kind of ontology? These are questions that we meet when working with people from industry and public authorities, who need methods and tools for concept clarification, for developing meta...... data sets or for obtaining advanced search facilities. In this paper we will present an attempt at answering these questions. We will give a presentation of various types of ontologies and briefly introduce terminological ontologies. Furthermore we will argue that classification systems, e.g. product...... classification systems and meta data taxonomies, should be based on ontologies....

  4. Biopharmaceutics data management system for anonymised data sharing and curation: First application with orbito IMI project.

    Science.gov (United States)

    Lacy-Jones, Kristin; Hayward, Philip; Andrews, Steve; Gledhill, Ian; McAllister, Mark; Abrahamsson, Bertil; Rostami-Hodjegan, Amin; Pepin, Xavier

    2017-03-01

    The OrBiTo IMI project was designed to improve the understanding and modelling of how drugs are absorbed. To achieve this 13 pharmaceutical companies agreed to share biopharmaceutics drug properties and performance data, as long as they were able to hide certain aspects of their dataset if required. This data was then used in simulations to test how three in silico Physiological Based Pharmacokinetic (PBPK) tools performed. A unique database system was designed and implemented to store the drug data. The database system was unique, in that it had the ability to make different sections of a dataset visible or hidden depending on the stage of the project. Users were also given the option to hide identifying API attributes, to help prevent identification of project members from previously published data. This was achieved by applying blinding strategies to data parameters and the adoption of a unique numbering system. An anonymous communication tool was proposed to exchange comments about data, which enabled its curation and evolution. This paper describes the strategy adopted for numbering and blinding of the data, the tools developed to gather and search data as well as the tools used for communicating around the data with the aim of publicising the approach for other pre-competitive research between organisations. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  5. An overview about biopharmaceutics in Europe.

    Science.gov (United States)

    Aiache, Jean-Marc

    2005-01-01

    In Europe, the concept of biopharmaceutics was first introduced at the end of the 70s by various highly informed young Europeans who took into full account the publications and studies carried out by the first generation of explorers in this area in the United States such as John Wagner, Gerhard Levy, and W.A. Ritschel, amongst others. Their primary aim was to develop bioavailability studies for the registration of generics or new dosage forms. They then worked on setting up a new system for drug dissolution in vitro, including in vitro and in vivo correlations to better define the formulations. All this research led to the publication of numerous reports on different congresses, the most important of these being the European Congress of Biopharmaceutics and Pharmacokinetics, which is held once every two years in a European country and includes a large number of participants with an attendance ranging from 300 to 500 persons. During this same period, books were published in French and other European languages such as English, German and Spanish, with the result that updated information was efficiently circulated throughout all European countries. In the near future, the introduction of the biopharmaceutical classification as well as new in vitro models will certainly make a positive contribution to the further development of research in this area.

  6. Oral epithelial dysplasia classification systems

    DEFF Research Database (Denmark)

    Warnakulasuriya, S; Reibel, J; Bouquot, J

    2008-01-01

    . In this report, we review the oral epithelial dysplasia classification systems. The three classification schemes [oral epithelial dysplasia scoring system, squamous intraepithelial neoplasia and Ljubljana classification] were presented and the Working Group recommended epithelial dysplasia grading for routine...

  7. Faculty Assignment Classification System.

    Science.gov (United States)

    Whatcom Community Coll., Ferndale, WA.

    This document outlines the point-based faculty assignment classification system in effect at Whatcom Community College (Washington). The purpose of the point system is to provide an equitable and flexible means of compensating faculty members based on a system of assigning quantitative values to tasks. Teaching, which includes classroom…

  8. Elucidating the role of dose in the biopharmaceutics classification of drugs: the concepts of critical dose, effective in vivo solubility, and dose-dependent BCS.

    Science.gov (United States)

    Charkoftaki, Georgia; Dokoumetzidis, Aristides; Valsami, Georgia; Macheras, Panos

    2012-11-01

    To develop a dose dependent version of BCS and identify a critical dose after which the amount absorbed is independent from the dose. We utilized a mathematical model of drug absorption in order to produce simulations of the fraction of dose absorbed (F) and the amount absorbed as function of the dose for the various classes of BCS and the marginal cases in between classes. Simulations based on the mathematical model of F versus dose produced patterns of a constant F throughout a wide range of doses for drugs of Classes I, II and III, justifying biowaiver claim. For Classes I and III the pattern of a constant F stops at a critical dose Dose(cr) after which the amount of drug absorbed, is independent from the dose. For doses higher than Dose(cr), Class I drugs become Class II and Class III drugs become Class IV. Dose(cr) was used to define an in vivo effective solubility as S(eff) = Dose(cr)/250 ml. Literature data were used to support our simulation results. A new biopharmaceutic classification of drugs is proposed, based on F, separating drugs into three regions, taking into account the dose, and Dose(cr), while the regions for claiming biowaiver are clearly defined.

  9. Ontologies vs. Classification Systems

    DEFF Research Database (Denmark)

    Madsen, Bodil Nistrup; Erdman Thomsen, Hanne

    2009-01-01

    data sets or for obtaining advanced search facilities. In this paper we will present an attempt at answering these questions. We will give a presentation of various types of ontologies and briefly introduce terminological ontologies. Furthermore we will argue that classification systems, e.g. product...

  10. Neuromuscular disease classification system

    Science.gov (United States)

    Sáez, Aurora; Acha, Begoña; Montero-Sánchez, Adoración; Rivas, Eloy; Escudero, Luis M.; Serrano, Carmen

    2013-06-01

    Diagnosis of neuromuscular diseases is based on subjective visual assessment of biopsies from patients by the pathologist specialist. A system for objective analysis and classification of muscular dystrophies and neurogenic atrophies through muscle biopsy images of fluorescence microscopy is presented. The procedure starts with an accurate segmentation of the muscle fibers using mathematical morphology and a watershed transform. A feature extraction step is carried out in two parts: 24 features that pathologists take into account to diagnose the diseases and 58 structural features that the human eye cannot see, based on the assumption that the biopsy is considered as a graph, where the nodes are represented by each fiber, and two nodes are connected if two fibers are adjacent. A feature selection using sequential forward selection and sequential backward selection methods, a classification using a Fuzzy ARTMAP neural network, and a study of grading the severity are performed on these two sets of features. A database consisting of 91 images was used: 71 images for the training step and 20 as the test. A classification error of 0% was obtained. It is concluded that the addition of features undetectable by the human visual inspection improves the categorization of atrophic patterns.

  11. G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability, Pharm Res 12, 413-420, 1995--backstory of BCS.

    Science.gov (United States)

    Shah, Vinod P; Amidon, Gordon L

    2014-09-01

    The Biopharmaceutics Classification System (BCS) has become widely accepted today in the academic, industrial, and regulatory world. While the initial application of the BCS was to regulatory science bioequivalence (BE) issues and related implications, it has come to be utilized widely by the pharmaceutical industry in drug discovery and development as well. This brief manuscript will relate the story of the BCS development. While much of the ground work for the BCS goes back to the pharmacokinetic and drug absorption research by Gordon Amidon (GLA) in the 1970s and 1980s, the realization of the need for a classification or categorization of drug and drug products for setting dissolution standards became apparent to GLA during his 1990-1991 sabbatical year at the FDA. Initiated at the invitation of the then CEDR director, Dr. Carl Peck, to become a visiting scientist at the FDA, the goal was to promote regulatory research at the FDA, in my case, in biopharmaceutics, and to develop a science-based system to simplify regulatory requirements.

  12. Modeling in biopharmaceutics, pharmacokinetics and pharmacodynamics homogeneous and heterogeneous approaches

    CERN Document Server

    Macheras, Panos

    2016-01-01

    The state of the art in Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics Modeling is presented in this new second edition book. It shows how advanced physical and mathematical methods can expand classical models in order to cover heterogeneous drug-biological processes and therapeutic effects in the body. The book is divided into four parts; the first deals with the fundamental principles of fractals, diffusion and nonlinear dynamics; the second with drug dissolution, release, and absorption; the third with epirical, compartmental, and stochastic pharmacokinetic models, with two new chapters, one on fractional pharmacokinetics and one on bioequivalence; and the fourth mainly with classical and nonclassical aspects of pharmacodynamics. The classical models that have relevance and application to these sciences are also considered throughout. This second edition has new information on reaction limited models of dissolution, non binary biopharmaceutic classification system, time varying models, and interf...

  13. Biopharmaceutical discovery and production in yeast.

    Science.gov (United States)

    Meehl, Michael A; Stadheim, Terrance A

    2014-12-01

    The selection of an expression platform for recombinant biopharmaceuticals is often centered upon suitable product titers and critical quality attributes, including post-translational modifications. Although notable differences between microbial, yeast, plant, and mammalian host systems exist, recent advances have greatly mitigated any inherent liabilities of yeasts. Yeast expression platforms are important to both the supply of marketed biopharmaceuticals and the pipelines of novel therapeutics. In this review, recent advances in yeast-based expression of biopharmaceuticals will be discussed. The advantages of using glycoengineered yeast as a production host and in the discovery space will be illustrated. These advancements, in turn, are transforming yeast platforms from simple production systems to key technological assets in the discovery and selection of biopharmaceutical lead candidates. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. Bosniak classification system

    DEFF Research Database (Denmark)

    Graumann, Ole; Osther, Susanne Sloth; Karstoft, Jens

    2016-01-01

    BACKGROUND: The Bosniak classification was originally based on computed tomographic (CT) findings. Magnetic resonance (MR) and contrast-enhanced ultrasonography (CEUS) imaging may demonstrate findings that are not depicted at CT, and there may not always be a clear correlation between the findings...... at MR and CEUS imaging and those at CT. PURPOSE: To compare diagnostic accuracy of MR, CEUS, and CT when categorizing complex renal cystic masses according to the Bosniak classification. MATERIAL AND METHODS: From February 2011 to June 2012, 46 complex renal cysts were prospectively evaluated by three...... readers. Each mass was categorized according to the Bosniak classification and CT was chosen as gold standard. Kappa was calculated for diagnostic accuracy and data was compared with pathological results. RESULTS: CT images found 27 BII, six BIIF, seven BIII, and six BIV. Forty-three cysts could...

  15. Classification system: Netherlands

    NARCIS (Netherlands)

    Hartemink, A.E.

    2006-01-01

    Although people have always classified soils, it is only since the mid 19th century that soil classification emerged as an important topic within soil science. It forced soil scientists to think systematically about soils and its genesis and developed to facilitate communication between soil

  16. Bosniak classification system

    DEFF Research Database (Denmark)

    Graumann, Ole; Osther, Susanne S; Karstoft, Jens

    2015-01-01

    BACKGROUND: The Bosniak classification is a diagnostic tool for the differentiation of cystic changes in the kidney. The process of categorizing renal cysts may be challenging, involving a series of decisions that may affect the final diagnosis and clinical outcome such as surgical management. PU...

  17. Comparison between different papillary recession classification systems

    Directory of Open Access Journals (Sweden)

    Li-Ching Chang

    2012-12-01

    Conclusion: This study confirmed a significant correlation between the two existing classification methods. The proposed PR classification system characterizes open embrasures in greater detail than previous systems.

  18. CLASSIFICATION OF LEARNING MANAGEMENT SYSTEMS

    Directory of Open Access Journals (Sweden)

    Yu. B. Popova

    2016-01-01

    Full Text Available Using of information technologies and, in particular, learning management systems, increases opportunities of teachers and students in reaching their goals in education. Such systems provide learning content, help organize and monitor training, collect progress statistics and take into account the individual characteristics of each user. Currently, there is a huge inventory of both paid and free systems are physically located both on college servers and in the cloud, offering different features sets of different licensing scheme and the cost. This creates the problem of choosing the best system. This problem is partly due to the lack of comprehensive classification of such systems. Analysis of more than 30 of the most common now automated learning management systems has shown that a classification of such systems should be carried out according to certain criteria, under which the same type of system can be considered. As classification features offered by the author are: cost, functionality, modularity, keeping the customer’s requirements, the integration of content, the physical location of a system, adaptability training. Considering the learning management system within these classifications and taking into account the current trends of their development, it is possible to identify the main requirements to them: functionality, reliability, ease of use, low cost, support for SCORM standard or Tin Can API, modularity and adaptability. According to the requirements at the Software Department of FITR BNTU under the guidance of the author since 2009 take place the development, the use and continuous improvement of their own learning management system.

  19. Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development-Industry Case Studies.

    Science.gov (United States)

    Kesisoglou, Filippos; Chung, John; van Asperen, Judith; Heimbach, Tycho

    2016-09-01

    In recent years, there has been a significant increase in use of physiologically based pharmacokinetic models in drug development and regulatory applications. Although most of the published examples have focused on aspects such as first-in-human (FIH) dose predictions or drug-drug interactions, several publications have highlighted the application of these models in the biopharmaceutics field and their use to inform formulation development. In this report, we present 5 case studies of use of such models in this biopharmaceutics/formulation space across different pharmaceutical companies. The case studies cover different aspects of biopharmaceutics or formulation questions including (1) prediction of absorption prior to FIH studies; (2) optimization of formulation and dissolution method post-FIH data; (3) early exploration of a modified-release formulation; (4) addressing bridging questions for late-stage formulation changes; and (5) prediction of pharmacokinetics in the fed state for a Biopharmaceutics Classification System class I drug with fasted state data. The discussion of the case studies focuses on how such models can facilitate decisions and biopharmaceutic understanding of drug candidates and the opportunities for increased use and acceptance of such models in drug development and regulatory interactions. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  20. INFORMATION SYSTEM SECURITY THREATS CLASSIFICATIONS

    Directory of Open Access Journals (Sweden)

    Sandro Gerić

    2007-06-01

    Full Text Available Information systems are exposed to different types of security risks. Theconsequences of information systems security (ISS breaches can vary from e.g. damaging the data base integrity to physical "destruction" of entire information system facilities, and can result with minor disruptions in less important segments of information systems, or with significant interruptions in information systems functionality. The sources of security risks are different, and can origin from inside or outside of information system facility, and can be intentional or unintentional. The precise calculation of loses caused by such incidents is often not possible because a number of small scale ISS incidents are never detected, or detected with a significant time delay, a part of incidents are interpreted as an accidental mistakes, and all that results with an underestimation of ISS risks. This paper addresses the different types and criteria of information system security risks (threats classification and gives an overview of most common classifications used in literature and in practice. We define a common set of criteria that can be used for information system security threats classification, which will enable the comparison and evaluation of different security threats from different security threats classifications.

  1. Design of PLGA-based depot delivery systems for biopharmaceuticals prepared by spray drying

    DEFF Research Database (Denmark)

    Wan, Feng; Yang, Mingshi

    2016-01-01

    , a one-step, continuous microencapsulation process, for manufacturing of PLGA-based depot microparticle systems with a focus on the recent efforts on understanding of the role of nozzle design in the microencapsulation of proteins/peptides, and the effect of critical solvent properties and process...

  2. Cell Engineering and Molecular Pharming for Biopharmaceuticals

    Science.gov (United States)

    Abdullah, M.A; Rahmah, Anisa ur; Sinskey, A.J; Rha, C.K

    2008-01-01

    Biopharmaceuticals are often produced by recombinant E. coli or mammalian cell lines. This is usually achieved by the introduction of a gene or cDNA coding for the protein of interest into a well-characterized strain of producer cells. Naturally, each recombinant production system has its own unique advantages and disadvantages. This paper examines the current practices, developments, and future trends in the production of biopharmaceuticals. Platform technologies for rapid screening and analyses of biosystems are reviewed. Strategies to improve productivity via metabolic and integrated engineering are also highlighted. PMID:19662143

  3. Multiple Fuzzy Classification Systems

    CERN Document Server

    Scherer, Rafał

    2012-01-01

    Fuzzy classifiers are important tools in exploratory data analysis, which is a vital set of methods used in various engineering, scientific and business applications. Fuzzy classifiers use fuzzy rules and do not require assumptions common to statistical classification. Rough set theory is useful when data sets are incomplete. It defines a formal approximation of crisp sets by providing the lower and the upper approximation of the original set. Systems based on rough sets have natural ability to work on such data and incomplete vectors do not have to be preprocessed before classification. To achieve better performance than existing machine learning systems, fuzzy classifiers and rough sets can be combined in ensembles. Such ensembles consist of a finite set of learning models, usually weak learners. The present book discusses the three aforementioned fields – fuzzy systems, rough sets and ensemble techniques. As the trained ensemble should represent a single hypothesis, a lot of attention is placed o...

  4. Investigating a new drug delivery nano composite membrane system based on PVA/PCL and PVA/HA(PEG) for the controlled release of biopharmaceuticals for bone infections.

    Science.gov (United States)

    Wan, Taoyu; Stylios, George K; Giannoudi, Marilena; Giannoudis, Peter V

    2015-12-01

    The capability for sustained and gradual release of pharmaceuticals is a major requirement in the development of a guided antimicrobial bacterial control system for clinical applications. In this study, PVA gels with varying constituents that were manufactured via a refreeze/thawing route, were found to have excellent potential for antimicrobial delivery for bone infections. Cefuroxime Sodium with poly(ethylene glycol) was incorporated into 2 delivery systems poly(e-caprolactone) (PCL) and hydroxyapatite (HA), by a modified emulsion process. Our results indicate that the Cefuroxime Sodium released from poly(e-caprolactone) in PVA was tailored to a sustained release over more than 45 days, while the release from hydroxyapatite PVA reach burst maximum after 20 days. These PVA hydrogel-systems were also capable of controlled and sustained release of other biopharmaceuticals. Copyright © 2015 Elsevier Ltd. All rights reserved.

  5. Analytical techniques for biopharmaceutical development

    National Research Council Canada - National Science Library

    Wehr, Tim; Rodríguez-Díaz, Roberto; Tuck, Stephen (Stephen F.)

    2005-01-01

    ... for biopharmaceutical development / Tim Wehr, Roberto RodriguezDiaz, Stephen Tuck, editors. p. ; cm. Includes bibliographical references and index. ISBN 0-8247-2667-7 (alk. paper) 1. Protein drugs--Analysis--Laboratory manuals. [DNLM: 1. Pharmaceutical Preparations--analysis--Laboratory Manuals. 2. Biopharmaceutics--methods--Laboratory Ma...

  6. Classification of Magnetic Nanoparticle Systems

    DEFF Research Database (Denmark)

    Bogren, Sara; Fornara, Andrea; Ludwig, Frank

    2015-01-01

    This study presents classification of different magnetic single- and multi-core particle systems using their measured dynamic magnetic properties together with their nanocrystal and particle sizes. The dynamic magnetic properties are measured with AC (dynamical) susceptometry and magnetorelaxometry...... and the size parameters are determined from electron microscopy and dynamic light scattering. Using these methods, we also show that the nanocrystal size and particle morphology determines the dynamic magnetic properties for both single- and multi-core particles. The presented results are obtained from...... the four year EU NMP FP7 project, NanoMag, which is focused on standardization of analysis methods for magnetic nanoparticles....

  7. Plant-made vaccine antigens and biopharmaceuticals.

    Science.gov (United States)

    Daniell, Henry; Singh, Nameirakpam D; Mason, Hugh; Streatfield, Stephen J

    2009-12-01

    Plant cells are ideal bioreactors for the production and oral delivery of vaccines and biopharmaceuticals, eliminating the need for expensive fermentation, purification, cold storage, transportation and sterile delivery. Plant-made vaccines have been developed for two decades but none has advanced beyond Phase I. However, two plant-made biopharmaceuticals are now advancing through Phase II and Phase III human clinical trials. In this review, we evaluate the advantages and disadvantages of different plant expression systems (stable nuclear and chloroplast or transient viral) and their current limitations or challenges. We provide suggestions for advancing this valuable concept for clinical applications and conclude that greater research emphasis is needed on large-scale production, purification, functional characterization, oral delivery and preclinical evaluation.

  8. AOSpine subaxial cervical spine injury classification system

    NARCIS (Netherlands)

    Vaccaro, Alexander R.; Koerner, John D.; Radcliff, Kris E.; Oner, F. Cumhur; Reinhold, Maximilian; Schnake, Klaus J.; Kandziora, Frank; Fehlings, Michael G.; Dvorak, Marcel F.; Aarabi, Bizhan; Rajasekaran, Shanmuganathan; Schroeder, Gregory D.; Kepler, Christopher K.; Vialle, Luiz R.

    2016-01-01

    Purpose: This project describes a morphology-based subaxial cervical spine traumatic injury classification system. Using the same approach as the thoracolumbar system, the goal was to develop a comprehensive yet simple classification system with high intra- and interobserver reliability to be used

  9. Discriminant forest classification method and system

    Science.gov (United States)

    Chen, Barry Y.; Hanley, William G.; Lemmond, Tracy D.; Hiller, Lawrence J.; Knapp, David A.; Mugge, Marshall J.

    2012-11-06

    A hybrid machine learning methodology and system for classification that combines classical random forest (RF) methodology with discriminant analysis (DA) techniques to provide enhanced classification capability. A DA technique which uses feature measurements of an object to predict its class membership, such as linear discriminant analysis (LDA) or Andersen-Bahadur linear discriminant technique (AB), is used to split the data at each node in each of its classification trees to train and grow the trees and the forest. When training is finished, a set of n DA-based decision trees of a discriminant forest is produced for use in predicting the classification of new samples of unknown class.

  10. Music Genre Classification Systems - A Computational Approach

    DEFF Research Database (Denmark)

    Ahrendt, Peter

    2006-01-01

    Automatic music genre classification is the classification of a piece of music into its corresponding genre (such as jazz or rock) by a computer. It is considered to be a cornerstone of the research area Music Information Retrieval (MIR) and closely linked to the other areas in MIR. It is thought...... that MIR will be a key element in the processing, searching and retrieval of digital music in the near future. This dissertation is concerned with music genre classification systems and in particular systems which use the raw audio signal as input to estimate the corresponding genre. This is in contrast...... to systems which use e.g. a symbolic representation or textual information about the music. The approach to music genre classification systems has here been system-oriented. In other words, all the different aspects of the systems have been considered and it is emphasized that the systems should...

  11. Use of artificial digestive systems to investigate the biopharmaceutical factors influencing the survival of probiotic yeast during gastrointestinal transit in humans.

    Science.gov (United States)

    Blanquet-Diot, Stéphanie; Denis, Sylvain; Chalancon, Sandrine; Chaira, Fehd; Cardot, Jean-Michel; Alric, Monique

    2012-06-01

    To evaluate the influence of the main biopharmaceutical factors on the viability of a new probiotic yeast strain, using dynamic in vitro systems simulating human gastric/small intestinal (TIM) and large intestinal (ARCOL) environments. The viability of Saccharomyces cerevisiae CNCM I-3856 throughout the artificial digestive tract was determined by microbial counting. We investigated the effects of galenic formulation, food intake, dose, mode and frequency of administration on yeast survival rate. In both fasted and fed states, yeast viability in the upper digestive tract was significantly higher when the probiotic was administered in hydroxypropylmethylcellulose (HPMC) capsules compared to tablets. Food intake led to a delay in yeast release and a two-fold increase in strain survival. Whatever the dose, yeasts were particularly sensitive to the large intestinal environment. High concentrations of probiotic could only be maintained in the colon when it was inoculated twice a day over a 5-h-period. TIM and ARCOL are complementary in vitro tools relevant for screening purposes, supplying valuable information on the effects of galenic form, food intake and dose regimen on the viability of probiotics throughout the human digestive tract.

  12. Evaluation of classification systems for nonspecific idiopathic orbital inflammation

    NARCIS (Netherlands)

    Bijlsma, Ward R.; van 't Hullenaar, Fleur C.; Mourits, Maarten P.; Kalmann, Rachel

    2012-01-01

    To systematically analyze existing classification systems for idiopathic orbital inflammation (IOI) and propose and test a new best practice classification system. A systematic literature search was conducted to find all studies that described and applied a classification system for IOI.

  13. Biopharmaceuticals from microorganisms: from production to purification

    Directory of Open Access Journals (Sweden)

    Angela Faustino Jozala

    Full Text Available ABSTRACT The use of biopharmaceuticals dates from the 19th century and within 5-10 years, up to 50% of all drugs in development will be biopharmaceuticals. In the 1980s, the biopharmaceutical industry experienced a significant growth in the production and approval of recombinant proteins such as interferons (IFN α, β, and γ and growth hormones. The production of biopharmaceuticals, known as bioprocess, involves a wide range of techniques. In this review, we discuss the technology involved in the bioprocess and describe the available strategies and main advances in microbial fermentation and purification process to obtain biopharmaceuticals.

  14. QA CLASSIFICATION ANALYSIS OF GROUND SUPPORT SYSTEMS

    International Nuclear Information System (INIS)

    D. W. Gwyn

    1996-01-01

    The purpose and objective of this analysis is to determine if the permanent function Ground Support Systems (CI: BABEEOOOO) are quality-affecting items and if so, to establish the appropriate Quality Assurance (QA) classification

  15. Land Cover - Minnesota Land Cover Classification System

    Data.gov (United States)

    Minnesota Department of Natural Resources — Land cover data set based on the Minnesota Land Cover Classification System (MLCCS) coding scheme. This data was produced using a combination of aerial photograph...

  16. Nonclinical strategy considerations for safety pharmacology: evaluation of biopharmaceuticals.

    Science.gov (United States)

    Vargas, Hugo M; Amouzadeh, Hamid R; Engwall, Michael J

    2013-01-01

    Biopharmaceuticals, such as monoclonal antibodies and recombinant peptides, are important therapeutics to treat human disease. Key features of biopharmaceuticals that make them innovative medicines are their clinical effectiveness, high specificity for their human target, long half-life and target coverage, and low risk for "off-target" pharmacology. This paper describes nonclinical safety pharmacology assessment of biopharmaceuticals with an emphasis on special considerations needed for these agents. Insight is provided on various approaches to conduct safety pharmacology studies for such therapeutics, including appropriate integration into non-rodent toxicity studies. The safety pharmacology evaluation of biopharmaceuticals requires a science-based, case-by-case approach, as each biological modality will have unique pharmacological characteristics that influence the overall nonclinical safety assessment strategy. The integration of safety pharmacology endpoints into general (repeat-dose) toxicity studies is a rational paradigm for assessing potential changes in the cardiovascular, central nervous, and respiratory systems, but requires thoughtful and practical planning. In some cases, especially based on target-pharmacology concerns, dedicated and optimally designed safety pharmacology studies may be needed to assess the functional risk of a new biopharmaceutical. For example, cardiovascular telemetry studies may be needed to detect small changes in arterial blood pressure after acute and chronic exposure.

  17. Animal models for evaluation of oral delivery of biopharmaceuticals

    DEFF Research Database (Denmark)

    Harloff-Helleberg, Stine; Nielsen, Line Hagner; Nielsen, Hanne Mørck

    2017-01-01

    of systems for oral delivery of biopharmaceuticals may result in new treatment modalities to increase the patient compliance and reduce product cost. In the preclinical development phase, use of experimental animal models is essential for evaluation of new formulation designs. In general, the limited oral...... bioavailability of biopharmaceuticals, of just a few percent, is expected, and therefore, the animal models and the experimental settings must be chosen with utmost care. More knowledge and focus on this topic is highly needed, despite experience from the numerous studies evaluating animal models for oral drug...... delivery of small molecule drugs. This review highlights and discusses pros and cons of the most currently used animal models and settings. Additionally, it also looks into the influence of anesthetics and sampling methods for evaluation of drug delivery systems for oral delivery of biopharmaceuticals...

  18. Production of biopharmaceutical proteins by yeast: Advances through metabolic engineering

    DEFF Research Database (Denmark)

    Nielsen, Jens

    2013-01-01

    Production of recombinant proteins for use as pharmaceuticals, so-called biopharmaceuticals, is a multi-billion dollar industry. Many different cell factories are used for the production of biopharmaceuticals, but the yeast Saccharomyces cerevisiae is an important cell factory as it is used for p...... production. The involvement of directed metabolic engineering through the integration of tools from genetic engineering, systems biology and mathematical modeling, is also discussed....... by yeast are human serum albumin, hepatitis vaccines and virus like particles used for vaccination against human papillomavirus. Here is given a brief overview of biopharmaceutical production by yeast and it is discussed how the secretory pathway can be engineered to ensure more efficient protein...

  19. Paediatric oral biopharmaceutics: key considerations and current challenges.

    Science.gov (United States)

    Batchelor, Hannah K; Fotaki, Nikoletta; Klein, Sandra

    2014-06-01

    The complex process of oral drug absorption is influenced by a host of drug and formulation properties as well as their interaction with the gastrointestinal environment in terms of drug solubility, dissolution, permeability and pre-systemic metabolism. For adult dosage forms the use of biopharmaceutical tools to aid in the design and development of medicinal products is well documented. This review considers current literature evidence to guide development of bespoke paediatric biopharmaceutics tools and reviews current understanding surrounding extrapolation of adult methodology into a paediatric population. Clinical testing and the use of in silico models were also reviewed. The results demonstrate that further work is required to adequately characterise the paediatric gastrointestinal tract to ensure that biopharmaceutics tools are appropriate to predict performance within this population. The most vulnerable group was found to be neonates and infants up to 6 months where differences from adults were greatest. © 2013.

  20. Generating Interpretable Fuzzy Systems for Classification Problems

    Directory of Open Access Journals (Sweden)

    Juan A. Contreras-Montes

    2009-12-01

    Full Text Available This paper presents a new method to generate interpretable fuzzy systems from training data to deal with classification problems. The antecedent partition uses triangular sets with 0.5 interpolations avoiding the presence of complex overlapping that happens in another method. Singleton consequents are generated form the projection of the modal values of each triangular membership function into the output space. Least square method is used to adjust the consequents. The proposed method gets a higher average classification accuracy rate than the existing methods with a reduced number of rules andparameters and without sacrificing the fuzzy system interpretability. The proposed approach is applied to two classical classification problems: Iris data and the Wisconsin Breast Cancer classification problem.

  1. Basics of Sterile Compounding: Biopharmaceutics of Injectable Dosage Forms.

    Science.gov (United States)

    Akers, Michael J

    2017-01-01

    Biopharmaceutics studies the relationship between the drug product and what happens after the product is administered. Since the majority of injectables are administered by the intravenous route, thus avoiding the need for drug absorption, not many articles are published compared to other routes of drug administration. However, other routes of administration for drug injection are becoming more frequent because of greater commercial availability of sustained- and controlled-release drug delivery systems. This article reviews basic principles of drug absorption, distribution, metabolism, and elimination of injectable drugs and certain physicochemical and physiological factors affecting injectable drug biopharmaceutics. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  2. Classification

    Science.gov (United States)

    Clary, Renee; Wandersee, James

    2013-01-01

    In this article, Renee Clary and James Wandersee describe the beginnings of "Classification," which lies at the very heart of science and depends upon pattern recognition. Clary and Wandersee approach patterns by first telling the story of the "Linnaean classification system," introduced by Carl Linnacus (1707-1778), who is…

  3. IMI - oral biopharmaceutics tools project - evaluation of bottom-up PBPK prediction success part 1: Characterisation of the OrBiTo database of compounds.

    Science.gov (United States)

    Margolskee, Alison; Darwich, Adam S; Pepin, Xavier; Pathak, Shriram M; Bolger, Michael B; Aarons, Leon; Rostami-Hodjegan, Amin; Angstenberger, Jonas; Graf, Franziska; Laplanche, Loic; Müller, Thomas; Carlert, Sara; Daga, Pankaj; Murphy, Dónal; Tannergren, Christer; Yasin, Mohammed; Greschat-Schade, Susanne; Mück, Wolfgang; Muenster, Uwe; van der Mey, Dorina; Frank, Kerstin Julia; Lloyd, Richard; Adriaenssen, Lieve; Bevernage, Jan; De Zwart, Loeckie; Swerts, Dominique; Tistaert, Christophe; Van Den Bergh, An; Van Peer, Achiel; Beato, Stefania; Nguyen-Trung, Anh-Thu; Bennett, Joanne; McAllister, Mark; Wong, Mei; Zane, Patricia; Ollier, Céline; Vicat, Pascale; Kolhmann, Markus; Marker, Alexander; Brun, Priscilla; Mazuir, Florent; Beilles, Stéphane; Venczel, Marta; Boulenc, Xavier; Loos, Petra; Lennernäs, Hans; Abrahamsson, Bertil

    2017-01-01

    Predicting oral bioavailability (F oral ) is of importance for estimating systemic exposure of orally administered drugs. Physiologically-based pharmacokinetic (PBPK) modelling and simulation have been applied extensively in biopharmaceutics recently. The Oral Biopharmaceutical Tools (OrBiTo) project (Innovative Medicines Initiative) aims to develop and improve upon biopharmaceutical tools, including PBPK absorption models. A large-scale evaluation of PBPK models may be considered the first step. Here we characterise the OrBiTo active pharmaceutical ingredient (API) database for use in a large-scale simulation study. The OrBiTo database comprised 83 APIs and 1475 study arms. The database displayed a median logP of 3.60 (2.40-4.58), human blood-to-plasma ratio of 0.62 (0.57-0.71), and fraction unbound in plasma of 0.05 (0.01-0.17). The database mainly consisted of basic compounds (48.19%) and Biopharmaceutics Classification System class II compounds (55.81%). Median human intravenous clearance was 16.9L/h (interquartile range: 11.6-43.6L/h; n=23), volume of distribution was 80.8L (54.5-239L; n=23). The majority of oral formulations were immediate release (IR: 87.6%). Human F oral displayed a median of 0.415 (0.203-0.724; n=22) for IR formulations. The OrBiTo database was found to be largely representative of previously published datasets. 43 of the APIs were found to satisfy the minimum inclusion criteria for the simulation exercise, and many of these have significant gaps of other key parameters, which could potentially impact the interpretability of the simulation outcome. However, the OrBiTo simulation exercise represents a unique opportunity to perform a large-scale evaluation of the PBPK approach to predicting oral biopharmaceutics. Copyright © 2016 Elsevier B.V. All rights reserved.

  4. Transgenic plants in the biopharmaceutical market.

    Science.gov (United States)

    Twyman, Richard M; Schillberg, Stefan; Fischer, Rainer

    2005-02-01

    Many of our 'small-molecule-drugs' are natural products from plants, or are synthetic compounds based on molecules found naturally in plants. However, the vast majority of the protein therapeutics (or biopharmaceuticals) we use are from animal or human sources, and are produced commercially in microbial or mammalian bioreactor systems. Over the last few years, it has become clear that plants have great potential for the production of human proteins and other protein-based therapeutic entities. Plants offer the prospect of inexpensive biopharmaceutical production without sacrificing product quality or safety, and following the success of several plant-derived technical proteins, the first therapeutic products are now approaching the market. In this review, the different plant-based production systems are discussed and the merits of transgenic plants are evaluated compared with other platforms. A detailed discussion is provided of the development issues that remain to be addressed before plants become an acceptable mainstream production technology. The many different proteins that have already been produced using plants are described, and a sketch of the current market and the activities of the key players is provided. Despite the currently unclear regulatory framework and general industry inertia, the benefits of plant-derived pharmaceuticals are now bringing the prospect of inexpensive veterinary and human medicines closer than ever before.

  5. Production planning of biopharmaceutical manufacture.

    OpenAIRE

    Lakhdar, K.

    2006-01-01

    Multiproduct manufacturing facilities running on a campaign basis are increasingly becoming the norm for biopharmaceuticals, owing to high risks of clinical failure, regulatory pressures and the increasing number of therapeutics in clinical evaluation. The need for such flexible plants and cost-effective manufacture pose significant challenges for planning and scheduling, which are compounded by long production lead times, intermediate product stability issues and the high cost - low volume n...

  6. Fission--fusion systems: classification and critique

    International Nuclear Information System (INIS)

    Lidsky, L.M.

    1974-01-01

    A useful classification scheme for hybrid systems is described and some common features that the scheme makes apparent are pointed out. The early history of fusion-fission systems is reviewed. Some designs are described along with advantages and disadvantages of each. The extension to low and moderate Q devices is noted. (U.S.)

  7. An evaluation of classification systems for stillbirth

    Directory of Open Access Journals (Sweden)

    Pattinson Robert

    2009-06-01

    Full Text Available Abstract Background Audit and classification of stillbirths is an essential part of clinical practice and a crucial step towards stillbirth prevention. Due to the limitations of the ICD system and lack of an international approach to an acceptable solution, numerous disparate classification systems have emerged. We assessed the performance of six contemporary systems to inform the development of an internationally accepted approach. Methods We evaluated the following systems: Amended Aberdeen, Extended Wigglesworth; PSANZ-PDC, ReCoDe, Tulip and CODAC. Nine teams from 7 countries applied the classification systems to cohorts of stillbirths from their regions using 857 stillbirth cases. The main outcome measures were: the ability to retain the important information about the death using the InfoKeep rating; the ease of use according to the Ease rating (both measures used a five-point scale with a score Results InfoKeep scores were significantly different across the classifications (p ≤ 0.01 due to low scores for Wigglesworth and Aberdeen. CODAC received the highest mean (SD score of 3.40 (0.73 followed by PSANZ-PDC, ReCoDe and Tulip [2.77 (1.00, 2.36 (1.21, 1.92 (1.24 respectively]. Wigglesworth and Aberdeen resulted in a high proportion of unexplained stillbirths and CODAC and Tulip the lowest. While Ease scores were different (p ≤ 0.01, all systems received satisfactory scores; CODAC received the highest score. Aberdeen and Wigglesworth showed poor agreement with kappas of 0.35 and 0.25 respectively. Tulip performed best with a kappa of 0.74. The remainder had good to fair agreement. Conclusion The Extended Wigglesworth and Amended Aberdeen systems cannot be recommended for classification of stillbirths. Overall, CODAC performed best with PSANZ-PDC and ReCoDe performing well. Tulip was shown to have the best agreement and a low proportion of unexplained stillbirths. The virtues of these systems need to be considered in the development of an

  8. Mapping a classification system to architectural education

    DEFF Research Database (Denmark)

    Hermund, Anders; Klint, Lars; Rostrup, Nicolai

    2015-01-01

    This paper examines to what extent a new classification system, Cuneco Classification System, CCS, proves useful in the education of architects, and to what degree the aim of an architectural education, rather based on an arts and crafts approach than a polytechnic approach, benefits from...... the distinct terminology of the classification system. The method used to examine the relationship between education, practice and the CCS bifurcates in a quantitative and a qualitative exploration: Quantitative comparison of the curriculum with the students’ own descriptions of their studies through...... a questionnaire survey among 88 students in graduate school. Qualitative interviews with a handful of practicing architects, to be able to cross check the relevance of the education with the profession. The examination indicates the need of a new definition, in addition to the CCS’s scale, covering the earliest...

  9. Next Generation Biopharmaceuticals: Product Development.

    Science.gov (United States)

    Mathaes, Roman; Mahler, Hanns-Christian

    2018-04-11

    Therapeutic proteins show a rapid market growth. The relatively young biotech industry already represents 20 % of the total global pharma market. The biotech industry environment has traditionally been fast-pasted and intellectually stimulated. Nowadays the top ten best selling drugs are dominated by monoclonal antibodies (mABs).Despite mABs being the biggest medical breakthrough in the last 25 years, technical innovation does not stand still.The goal remains to preserve the benefits of a conventional mAB (serum half-life and specificity) whilst further improving efficacy and safety and to open new and better avenues for treating patients, e.g., improving the potency of molecules, target binding, tissue penetration, tailored pharmacokinetics, and reduced adverse effects or immunogenicity.The next generation of biopharmaceuticals can pose specific chemistry, manufacturing, and control (CMC) challenges. In contrast to conventional proteins, next-generation biopharmaceuticals often require lyophilization of the final drug product to ensure storage stability over shelf-life time. In addition, next-generation biopharmaceuticals require analytical methods that cover different ways of possible degradation patterns and pathways, and product development is a long way from being straight forward. The element of "prior knowledge" does not exist equally for most novel formats compared to antibodies, and thus the assessment of critical quality attributes (CQAs) and the definition of CQA assessment criteria and specifications is difficult, especially in early-stage development.

  10. Bioethical issues in the development of biopharmaceuticals

    Directory of Open Access Journals (Sweden)

    Todorović Zoran

    2012-01-01

    Full Text Available Development of biopharmaceuticals is a challenging issue in bioethics. Unlike conventional, small molecular weight drugs, biopharmaceuticals are proteins derived from DNA technology and hybrid techniques with complex three dimensional structures. Immunogenicity of biopharmaceuticals should always be tested in clinical settings due to low predictive value of preclinical animal models. However, non-human primates (NHP and transgenic mice could be used to address certain aspects of immunogenicity. Substantial efforts have been made to reduce NHP use in biopharmaceutical drug development, e.g. study design improvements and changes in regulatory policy. In addition, several expert groups are active in this field (e.g. NC3Rs, BioSafe, and Biopharmaceutical Technical Group. Despite that, there is an increasing trend of use of NHP in preclinical safety testing of biopharmaceuticals, especially regarding monoclonal antibodies. Other potential bioethical issues related biopharmaceutical drug development are their cost/effectiveness ratio, clinical safety assessment, production of biosimilars, and comparison of their efficacy with placebo in countries without intention to market. Identification of the human genome has opened many new bioethical issues. Development of biopharmaceuticals is an important bioethical issue for several reasons. It connects all aspects of contemporary bioethics: bio­medicine (e.g. clinical trials in vulnerable subjects, animal welfare and the most recent ad­vances in biotechnology. In particular, biopharmaceutical drug development is a challenging issue regarding treatment of rare diseases.

  11. Inhaled biopharmaceutical drug development: nonclinical considerations and case studies.

    Science.gov (United States)

    McElroy, Mary C; Kirton, Chris; Gliddon, Dan; Wolff, Ron K

    2013-03-01

    Biopharmaceuticals are complex molecules often manufactured from living systems and their specificity and novelty holds great promise for the treatment of chronic diseases for which there are currently no cures. The inhalation route of biopharmaceutical drug delivery is attractive because the large surface area of the lung, and close proximity of the alveolar and vascular systems, maximizes the potential for drug delivery to the lung and/or systemic circulation. In addition, costs of delivery to the patient are potentially much reduced, in comparison with parental administration, since inhalation is non-invasive and likely to promote patient compliance. However, in comparison with small molecule drug development, developing an inhaled biopharmaceutical that is effective and safe for human use is associated with many challenges. This review considers some general principles of drug delivery to lung and issues associated with the translation of proof of concept studies to toxicology safety studies (e.g. aerosol generation, species selection, exaggerated pharmacology, and immunogenicity). This review also presents a summary of nonclinical and clinical data from inhaled biopharmaceuticals which are either marketed for human use or in Phase II clinical trials (e.g. DNase, insulin, human growth hormone, vaccines, therapeutic plasmid DNA complexes).

  12. Classification System for Mortgage Arrear Management

    NARCIS (Netherlands)

    Sun, Zhe; Wiering, Marco; Petkov, Nicolai

    2014-01-01

    Due to the economic recession in the recent years, more and more mortgage customers default on the payments. This brings tremendous losses to banks and forces their arrear management departments to develop more efficient processes. In this paper, we propose a classification system to predict the

  13. Transposition revisited: New classification and notation system

    Directory of Open Access Journals (Sweden)

    Anshu Rai

    2016-01-01

    Full Text Available Introduction: Dental transposition is a rare and severe anomaly of eruptive position with varied expression. Previously, tooth transpositions have been classified according to the teeth and jaw involved, or by designating specific terms to the different types of transposition (e.g., complete/incomplete, true/false, partial, simple, coronal, and pseudotransposition. However, there is no comprehensive classification-notation system for transposition in literature that systematically discriminates the condition and presents utmost facts for the same. Materials and Methods: To know all the possible types of tooth transposition, literature was searched in PubMed and Medline library, with the keyword “tooth transposition.” A total of 494 articles were obtained. These articles were read, and all possible types of transposition were noted. The obtained data were analyzed systematically and comparatively to design a new classification-notation system. Result and Conclusion: This classification-notation system is outlined to avoid confusion, to ease communication, and to provide a better understanding of the prevailing anomaly. It is easy to remember and convey maximum information. Further, to make it easy for computer archiving, some abbreviations and symbols are added to this classification-notation system.

  14. Classification of ERP System Services

    Directory of Open Access Journals (Sweden)

    Petr Sodomka

    2016-07-01

    Full Text Available Today the ERP business information systems are an essential tool for organization management, regardless of size and field of activity. Their successful implementation and use is conditioned predominantly by IS/ICT knowledge and managerial skills required for directing their life cycle correctly. Defining and correct setting of the service level is a key requirement and skill, usually provided by a service provider based on an implementation and service contract, or an advisory organization, in particular when presale services concerning analyses and tender documentation processing are provided. The following paper discusses the characteristics of the individual service types and the particulars of their practical use. Moreover, it presents the selected significant results of the long-term research performed by the authors in the Center for inVestigations into Information Systems.

  15. The development of a classification system for inland aquatic ...

    African Journals Online (AJOL)

    A classification system is described that was developed for inland aquatic ecosystems in South Africa, including wetlands. The six-tiered classification system is based on a top-down, hierarchical classification of aquatic ecosystems, following the functionally-oriented hydrogeomorphic (HGM) approach to classification but ...

  16. Common occupational classification system - revision 3

    Energy Technology Data Exchange (ETDEWEB)

    Stahlman, E.J.; Lewis, R.E.

    1996-05-01

    Workforce planning has become an increasing concern within the DOE community as the Office of Environmental Restoration and Waste Management (ER/WM or EM) seeks to consolidate and refocus its activities and the Office of Defense Programs (DP) closes production sites. Attempts to manage the growth and skills mix of the EM workforce while retaining the critical skills of the DP workforce have been difficult due to the lack of a consistent set of occupational titles and definitions across the complex. Two reasons for this difficulty may be cited. First, classification systems commonly used in industry often fail to cover in sufficient depth the unique demands of DOE`s nuclear energy and research community. Second, the government practice of contracting the operation of government facilities to the private sector has introduced numerous contractor-specific classification schemes to the DOE complex. As a result, sites/contractors report their workforce needs using unique classification systems. It becomes difficult, therefore, to roll these data up to the national level necessary to support strategic planning and analysis. The Common Occupational Classification System (COCS) is designed to overcome these workforce planning barriers. The COCS is based on earlier workforce planning activities and the input of technical, workforce planning, and human resource managers from across the DOE complex. It provides a set of mutually-exclusive occupation titles and definitions that cover the broad range of activities present in the DOE complex. The COCS is not a required record-keeping or data management guide. Neither is it intended to replace contractor/DOE-specific classification systems. Instead, the system provides a consistent, high- level, functional structure of occupations to which contractors can crosswalk (map) their job titles.

  17. CLASSIFICATION OF THE MGR SITE OPERATIONS SYSTEM

    International Nuclear Information System (INIS)

    J.A. Ziegler

    1999-01-01

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) site operations system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333P, ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998)

  18. CLASSIFICATION OF THE MGR SUBSURFACE EXCAVATION SYSTEM

    International Nuclear Information System (INIS)

    R. Garrett

    1999-01-01

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) subsurface excavation system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333P, ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998)

  19. CLASSIFICATION OF THE MGR SITE WATER SYSTEM

    International Nuclear Information System (INIS)

    J.A. Ziegler

    1999-01-01

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) site water system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333P, ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998)

  20. CLASSIFICATION OF THE MGR EMERGENCY RESPONSE SYSTEM

    International Nuclear Information System (INIS)

    Zeigler, J.A.

    1999-01-01

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) emergency response system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333P7 ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998)

  1. CLASSIFICATION OF THE MGR SITE LAYOUT SYSTEM

    International Nuclear Information System (INIS)

    S.E. Salzman

    1999-01-01

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) site layout system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333P, ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998)

  2. CLASSIFICATION OF THE MGR SUBSURFACE VENTILATION SYSTEM

    International Nuclear Information System (INIS)

    R.J. Garrett

    1999-01-01

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) subsurface ventilation system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333P7 ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998)

  3. Comparative evaluation of the biopharmaceutical and chemical ...

    African Journals Online (AJOL)

    Erah

    Purpose: This study was undertaken with the objective of evaluating the biopharmaceutical equivalency of ten brands of ciprofloxacin tablets and the chemical equivalency with the use of an analytical method, which will be easy to use, accurate, reproducible, simple, and inexpensive. Method: The biopharmaceutical and ...

  4. Small and Medium Enterprises and Biopharmaceutical Innovations ...

    African Journals Online (AJOL)

    ... biopharmaceutical products that have been approved with about 400 presently marketable in the United States and European markets. The full potential of biopharmaceutical, biotechnology, genomic, genetic and biogeneric compounds is best realized in small entrepreneurial firms which have the capacity for creativity, ...

  5. Biosurfactants in cosmetics and biopharmaceuticals.

    Science.gov (United States)

    Varvaresou, A; Iakovou, K

    2015-09-01

    Biosurfactants are surface-active biomolecules that are produced by various micro-organisms. They show unique properties i.e. lower toxicity, higher biodegradability and environmental compatibility compared to their chemical counterparts. Glycolipids and lipopeptides have prompted application in biotechnology and cosmetics due to their multi-functional profile i.e. detergency, emulsifying, foaming and skin hydrating properties. Additionally, some of them can be served as antimicrobials. In this study the current status of research and development on rhamnolipids, sophorolipids, mannosyloerythritol lipids, trehalipids, xylolipids and lipopeptides particularly their commercial application in cosmetics and biopharmaceuticals, is described. © 2015 The Society for Applied Microbiology.

  6. Just how good an investment is the biopharmaceutical sector?

    Science.gov (United States)

    Thakor, Richard T; Anaya, Nicholas; Zhang, Yuwei; Vilanilam, Christian; Siah, Kien Wei; Wong, Chi Heem; Lo, Andrew W

    2017-12-01

    Uncertainty surrounding the risk and reward of investments in biopharmaceutical companies poses a challenge to those interested in funding such enterprises. Using data on publicly traded stocks, we track the performance of 1,066 biopharmaceutical companies from 1930 to 2015-the most comprehensive financial analysis of this sector to date. Our systematic exploration of methods for distinguishing biotech and pharmaceutical companies yields a dynamic, more accurate classification method. We find that the performance of the biotech sector is highly sensitive to the presence of a few outlier companies, and confirm that nearly all biotech companies are loss-making enterprises, exhibiting high stock volatility. In contrast, since 2000, pharmaceutical companies have become increasingly profitable, with risk-adjusted returns consistently outperforming the market. The performance of all biopharmaceutical companies is subject not only to factors arising from their drug pipelines (idiosyncratic risk), but also from general economic conditions (systematic risk). The risk associated with returns has profound implications both for patterns of investment and for funding innovation in biomedical R&D.

  7. Classification of Dynamic Vehicle Routing Systems

    DEFF Research Database (Denmark)

    Larsen, Allan; Madsen, Oli B.G.; Solomon, Marius M.

    2007-01-01

    This chapter discusses important characteristics seen within dynamic vehicle routing problems. We discuss the differences between the traditional static vehicle routing problems and its dynamic counterparts. We give an in-depth introduction to the degree of dynamism measure which can be used...... to classify dynamic vehicle routing systems. Methods for evaluation of the performance of algorithms that solve on-line routing problems are discussed and we list some of the most important issues to include in the system objective. Finally, we provide a three-echelon classification of dynamic vehicle routing...... systems based on their degree of dynamism and the system objective....

  8. Intelligent Computer Vision System for Automated Classification

    International Nuclear Information System (INIS)

    Jordanov, Ivan; Georgieva, Antoniya

    2010-01-01

    In this paper we investigate an Intelligent Computer Vision System applied for recognition and classification of commercially available cork tiles. The system is capable of acquiring and processing gray images using several feature generation and analysis techniques. Its functionality includes image acquisition, feature extraction and preprocessing, and feature classification with neural networks (NN). We also discuss system test and validation results from the recognition and classification tasks. The system investigation also includes statistical feature processing (features number and dimensionality reduction techniques) and classifier design (NN architecture, target coding, learning complexity and performance, and training with our own metaheuristic optimization method). The NNs trained with our genetic low-discrepancy search method (GLPτS) for global optimisation demonstrated very good generalisation abilities. In our view, the reported testing success rate of up to 95% is due to several factors: combination of feature generation techniques; application of Analysis of Variance (ANOVA) and Principal Component Analysis (PCA), which appeared to be very efficient for preprocessing the data; and use of suitable NN design and learning method.

  9. A comprehensive classification system for lipids

    OpenAIRE

    Fahy, E.; Subramaniam, S.; Brown, H.A.; Glass, C.K.; Merrill, A.H.; Murphy, R.C.; Raetz, C.R.H.; Russell, D.W.; Seyama, Y.; Shaw, W.; Shimizu, T.; Spener, F.; van Meer, G.; VanNieuwenhze, M.S.; White, S.H.

    2005-01-01

    Lipids are produced, transported, and recognized by the concerted actions of numerous enzymes, binding proteins, and receptors. A comprehensive analysis of lipid molecules, “lipidomics,” in the context of genomics and proteomics is crucial to understanding cellular physiology and pathology; consequently, lipid biology has become a major research target of the postgenomic revolution and systems biology. To facilitate international communication about lipids, a comprehensive classification of l...

  10. Railroad Classification Yard Technology Manual: Volume II : Yard Computer Systems

    Science.gov (United States)

    1981-08-01

    This volume (Volume II) of the Railroad Classification Yard Technology Manual documents the railroad classification yard computer systems methodology. The subjects covered are: functional description of process control and inventory computer systems,...

  11. The development of Bio-pharmaceutical industry in China: problems and solutions.

    Science.gov (United States)

    Yan, Gujun

    2014-07-01

    Known as the "sunrise industry" of the 21st century, bio-pharmaceutical industry has been a fast-growing global industry, and many countries have been developing this industry as the focus of their national economies. In China, there exists a huge market demand for the development of bio-pharmaceutical industry, but at the present stage the industry is faced with some problems, such as low level of R & D for innovative drugs, and inappropriate capital investment in the industrialization. In order to accelerate the development of China's bio-pharmaceutical industry, it is necessary to take strategic initiatives of improving the technology transfer system, developing the bio-pharmaceutical outsourcing, and building a diversified industrial financing system.

  12. Search techniques in intelligent classification systems

    CERN Document Server

    Savchenko, Andrey V

    2016-01-01

    A unified methodology for categorizing various complex objects is presented in this book. Through probability theory, novel asymptotically minimax criteria suitable for practical applications in imaging and data analysis are examined including the special cases such as the Jensen-Shannon divergence and the probabilistic neural network. An optimal approximate nearest neighbor search algorithm, which allows faster classification of databases is featured. Rough set theory, sequential analysis and granular computing are used to improve performance of the hierarchical classifiers. Practical examples in face identification (including deep neural networks), isolated commands recognition in voice control system and classification of visemes captured by the Kinect depth camera are included. This approach creates fast and accurate search procedures by using exact probability densities of applied dissimilarity measures. This book can be used as a guide for independent study and as supplementary material for a technicall...

  13. Glyco-engineering for biopharmaceutical production in moss bioreactors

    OpenAIRE

    Decker, Eva L.; Parsons, Juliana; Reski, Ralf

    2014-01-01

    The production of recombinant biopharmaceuticals (pharmaceutical proteins) is a strongly growing area in the pharmaceutical industry. While most products to date are produced in mammalian cell cultures, namely Chinese hamster ovary cells, plant-based production systems gained increasing acceptance over the last years. Different plant systems have been established which are suitable for standardization and precise control of cultivation conditions, thus meeting the criteria for pharmaceutical ...

  14. Explosives Classifications Tracking System User Manual

    Energy Technology Data Exchange (ETDEWEB)

    Genoni, R.P.

    1993-10-01

    The Explosives Classification Tracking System (ECTS) presents information and data for U.S. Department of Energy (DOE) explosives classifications of interest to EM-561, Transportation Management Division, other DOE facilities, and contractors. It is intended to be useful to the scientist, engineer, and transportation professional, who needs to classify or transport explosives. This release of the ECTS reflects upgrading of the software which provides the user with an environment that makes comprehensive retrieval of explosives related information quick and easy. Quarterly updates will be provided to the ECTS throughout its development in FY 1993 and thereafter. The ECTS is a stand alone, single user system that contains unclassified, publicly available information, and administrative information (contractor names, product descriptions, transmittal dates, EX-Numbers, etc.) information from many sources for non-decisional engineering and shipping activities. The data is the most up-to-date and accurate available to the knowledge of the system developer. The system is designed to permit easy revision and updating as new information and data become available. These, additions and corrections are welcomed by the developer. This user manual is intended to help the user install, understand, and operate the system so that the desired information may be readily obtained, reviewed, and reported.

  15. Exploring the potential of Saccharomyces cerevisiae for biopharmaceutical protein production

    DEFF Research Database (Denmark)

    Wang, Guokun; Huang, Mingtao; Nielsen, Jens

    2017-01-01

    Production of recombinant proteins by yeast plays a vital role in the biopharmaceutical industry. It is therefore desirable to develop yeast platform strains for over-production of various biopharmaceutical proteins, but this requires fundamental knowledge of the cellular machinery, especially...... synthetic biology tools, coupled with high-throughput screening are, however, also efficient approaches to relieve bottlenecks hindering high-level protein production. Here we review advances in systems biology and metabolic engineering of yeast for improving recombinant protein production....... the protein secretory pathway. Integrated analyses of multi-omics datasets can provide comprehensive understanding of cellular function, and can enable systems biology-driven and mathematical model-guided strain engineering. Rational engineering and introduction of trackable genetic modifications using...

  16. Extensions to the Speech Disorders Classification System (SDCS)

    Science.gov (United States)

    Shriberg, Lawrence D.; Fourakis, Marios; Hall, Sheryl D.; Karlsson, Heather B.; Lohmeier, Heather L.; McSweeny, Jane L.; Potter, Nancy L.; Scheer-Cohen, Alison R.; Strand, Edythe A.; Tilkens, Christie M.; Wilson, David L.

    2010-01-01

    This report describes three extensions to a classification system for paediatric speech sound disorders termed the Speech Disorders Classification System (SDCS). Part I describes a classification extension to the SDCS to differentiate motor speech disorders from speech delay and to differentiate among three sub-types of motor speech disorders.…

  17. Application of in vitro transmucosal permeability, dose number, and maximum absorbable dose for biopharmaceutics assessment during early drug development for intraoral delivery.

    Science.gov (United States)

    Yang, Zhen; Sotthivirat, Sutthilug; Wu, Yunhui; Lalloo, Anita; Nissley, Becky; Manser, Kimberly; Li, Hankun

    2016-04-30

    Intraoral (IO) administration is a unique route that takes advantage of transmucosal absorption in the oral cavity to deliver a drug substance locally or systemically. IO delivery can also enhance or enable oral administration, providing a better therapeutic benefit/safety risk profile for patient compliance. However, there are relatively few systematic biopharmaceutics assessments for IO delivery to date. Therefore, the goals of this study were to i) identify the most relevant in vitro permeability models as alternatives to porcine oral tissues (gold standard) for predicting human IO absorption and ii) establish guidelines for biopharmaceutics assessment during early drug development for IO delivery. Porcine kidney LLC-PK1 cells provided the strongest correlation of transmucosal permeability with porcine oral tissues followed by human Caco-2 cells. Furthermore, cultured human buccal tissues predicted high/low permeability classification and correlated well with porcine oral tissues, which are used for predicting clinical IO absorption. In the meantime, we introduced maximum absorbable dose and dose number in the oral cavity for IO delivery assessment as well as a decision tree to provide guidance for biopharmaceutics assessment during early drug development for IO delivery. Copyright © 2016 Elsevier B.V. All rights reserved.

  18. Process analytical technology (PAT) for biopharmaceuticals

    DEFF Research Database (Denmark)

    Glassey, Jarka; Gernaey, Krist; Clemens, Christoph

    2011-01-01

    Process analytical technology (PAT), the regulatory initiative for building in quality to pharmaceutical manufacturing, has a great potential for improving biopharmaceutical production. The recommended analytical tools for building in quality, multivariate data analysis, mechanistic modeling, nov...

  19. The interobserver reliability of classification systems for radial head fractures: the Hotchkiss modification of the Mason classification and the AO classification systems.

    Science.gov (United States)

    Sheps, David M; Kiefer, Krystina R L; Boorman, Richard S; Donaghy, John; Lalani, Aleem; Walker, Richard; Hildebrand, Kevin A

    2009-08-01

    BACKGROUND: Radial head fractures are common injuries, and there is little information on the reliability of classification systems for such injuries. The purpose of our study was to report the interobserver reliability of 2 commonly used classification systems: the Hotchkiss modification of the Mason classification and the AO classification systems. METHODS: We compiled the radiographs from a cohort series of 43 patients with radial head fractures, and 5 observers classified the radiographs according to both classification systems. Additionally, we collapsed the systems, with types II and III combined for the Hotchkiss classification and the final digit dropped for the AO classification. We calculated percent agreement, the kappa statistic and the associated 95% confidence intervals (CIs). RESULTS: The mean percent agreement was 72.3% (95% CI 65.8%-78.9%) for the Hotchkiss classification and 37.7% (95% CI 30.5%-44.9%) for the AO classification. The kappa statistic was 0.585 (0.541-0.661) for the Hotchkiss classification and 0.261 (0.240-0.350) for the AO classification. The mean percent agreement was 89.3% (86.6%-92.0%) for the consolidated Hotchkiss classification and 67.4% (54.6%-80.3%) for the consolidated AO classification. The kappa statistic was 0.760 (0.691-0.805) for the consolidated Hotchkiss classification and 0.455 (0.372-0.521) for the consolidated AO classification. CONCLUSION: The interobserver reliability for the Hotchkiss modification of the Mason classification was moderate, and that for the AO classification was fair according to the criteria of Landis and Koch. Collapsing the Hotchkiss classification improved the reliability to substantial, and collapsing the AO system improved reliability to the lower end of moderate.

  20. Nuclear reactors transients identification and classification system

    International Nuclear Information System (INIS)

    Bianchi, Paulo Henrique

    2008-01-01

    This work describes the study and test of a system capable to identify and classify transients in thermo-hydraulic systems, using a neural network technique of the self-organizing maps (SOM) type, with the objective of implanting it on the new generations of nuclear reactors. The technique developed in this work consists on the use of multiple networks to do the classification and identification of the transient states, being each network a specialist at one respective transient of the system, that compete with each other using the quantization error, that is a measure given by this type of neural network. This technique showed very promising characteristics that allow the development of new functionalities in future projects. One of these characteristics consists on the potential of each network, besides responding what transient is in course, could give additional information about that transient. (author)

  1. Gynecomastia Classification for Surgical Management: A Systematic Review and Novel Classification System.

    Science.gov (United States)

    Waltho, Daniel; Hatchell, Alexandra; Thoma, Achilleas

    2017-03-01

    Gynecomastia is a common deformity of the male breast, where certain cases warrant surgical management. There are several surgical options, which vary depending on the breast characteristics. To guide surgical management, several classification systems for gynecomastia have been proposed. A systematic review was performed to (1) identify all classification systems for the surgical management of gynecomastia, and (2) determine the adequacy of these classification systems to appropriately categorize the condition for surgical decision-making. The search yielded 1012 articles, and 11 articles were included in the review. Eleven classification systems in total were ascertained, and a total of 10 unique features were identified: (1) breast size, (2) skin redundancy, (3) breast ptosis, (4) tissue predominance, (5) upper abdominal laxity, (6) breast tuberosity, (7) nipple malposition, (8) chest shape, (9) absence of sternal notch, and (10) breast skin elasticity. On average, classification systems included two or three of these features. Breast size and ptosis were the most commonly included features. Based on their review of the current classification systems, the authors believe the ideal classification system should be universal and cater to all causes of gynecomastia; be surgically useful and easy to use; and should include a comprehensive set of clinically appropriate patient-related features, such as breast size, breast ptosis, tissue predominance, and skin redundancy. None of the current classification systems appears to fulfill these criteria.

  2. Development of a Wave Resource Classification System

    Science.gov (United States)

    Ahn, S.; Haas, K. A.; Neary, V. S.; Bredin, S.

    2016-12-01

    As the wave energy industry develops, detailed classification systems for wave resource assessments are beneficial for characterizing the wave resource statistics of particular sites and codifying opportunities and risks at these sites. Despite the wide spread availability of wave buoy data for the United States, this is currently insufficient to develop a classification scheme. Therefore, data from the 3rd generation wave model (WWIII) is utilized. Key wave resource statistics for the entire US territorial waters are computed and retained as time-series using a 30-year hindcast (1980-2009) wave spectra including: Annual available energy (AAE), omni-directional wave power, significant wave height, energy period, spectral width, direction of maximum directionally resolved wave power and directionality coefficient. The hindcast data are extensively validated with the available buoy wave measurements using the validation methodology recommended by the IEC standard for wave energy resource assessments (IEC TS 62600-101). As a high level wave classification, the AAE density is the primary indicator of wave energy resources. The AAE is analogous to annual energy production (AEP) without considering the energy conversion process. It can be thought as the theoretical available wave energy resource for any particular location. The AAE is separated into four different classes of ascending energy levels, 0, I, II, and III. Because of the dependence of wave energy devices on wave frequencies, the AAE for the US territorial waters are computed for the full spectrum along with different frequency bands corresponding to wind sea, swell and transitional sea states. The geographic distribution for the different wave classes within each frequency band have been determined. Finally, subclasses based on the extreme wave conditions will also be presented.

  3. Functional classifications for cerebral palsy: correlations between the gross motor function classification system (GMFCS), the manual ability classification system (MACS) and the communication function classification system (CFCS).

    Science.gov (United States)

    Compagnone, Eliana; Maniglio, Jlenia; Camposeo, Serena; Vespino, Teresa; Losito, Luciana; De Rinaldis, Marta; Gennaro, Leonarda; Trabacca, Antonio

    2014-11-01

    This study aimed to investigate a possible correlation between the gross motor function classification system-expanded and revised (GMFCS-E&R), the manual abilities classification system (MACS) and the communication function classification system (CFCS) functional levels in children with cerebral palsy (CP) by CP subtype. It was also geared to verify whether there is a correlation between these classification systems and intellectual functioning (IF) and parental socio-economic status (SES). A total of 87 children (47 males and 40 females, age range 4-18 years, mean age 8.9±4.2) were included in the study. A strong correlation was found between the three classifications: Level V of the GMFCS-E&R corresponds to Level V of the MACS (rs=0.67, p=0.001); the same relationship was found for the CFCS and the MACS (rs=0.73, p<0.001) and for the GMFCS-E&R and the CFCS (rs=0.61, p=0.001). The correlations between the IQ and the global functional disability profile were strong or moderate (GMFCS and IQ: rs=0.66, p=0.001; MACS and IQ: rs=0.58, p=0.001; CFCS and MACS: rs=0.65, p=0.001). The Kruskal-Wallis test was used to determine if there were differences between the GMFCS-E&R, the CFCS and the MACS by CP type. CP types showed different scores for the IQ level (Chi-square=8.59, df=2, p=0.014), the GMFCS-E&R (Chi-square=36.46, df=2, p<0.001), the CFCS (Chi-square=12.87, df=2, p=0.002), and the MACS Level (Chi-square=13.96, df=2, p<0.001) but no significant differences emerged for the SES (Chi-square=1.19, df=2, p=0.554). This study shows how the three functional classifications (GMFCS-E&R, CFCS and MACS) complement each other to provide a better description of the functional profile of CP. The systematic evaluation of the IQ can provide useful information about a possible future outcome for every functional level. The SES does not appear to affect functional profiles. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. A comprehensive classification system for lipids.

    Science.gov (United States)

    Fahy, Eoin; Subramaniam, Shankar; Brown, H Alex; Glass, Christopher K; Merrill, Alfred H; Murphy, Robert C; Raetz, Christian R H; Russell, David W; Seyama, Yousuke; Shaw, Walter; Shimizu, Takao; Spener, Friedrich; van Meer, Gerrit; VanNieuwenhze, Michael S; White, Stephen H; Witztum, Joseph L; Dennis, Edward A

    2005-05-01

    Lipids are produced, transported, and recognized by the concerted actions of numerous enzymes, binding proteins, and receptors. A comprehensive analysis of lipid molecules, "lipidomics," in the context of genomics and proteomics is crucial to understanding cellular physiology and pathology; consequently, lipid biology has become a major research target of the postgenomic revolution and systems biology. To facilitate international communication about lipids, a comprehensive classification of lipids with a common platform that is compatible with informatics requirements has been developed to deal with the massive amounts of data that will be generated by our lipid community. As an initial step in this development, we divide lipids into eight categories (fatty acyls, glycerolipids, glycerophospholipids, sphingolipids, sterol lipids, prenol lipids, saccharolipids, and polyketides) containing distinct classes and subclasses of molecules, devise a common manner of representing the chemical structures of individual lipids and their derivatives, and provide a 12 digit identifier for each unique lipid molecule. The lipid classification scheme is chemically based and driven by the distinct hydrophobic and hydrophilic elements that compose the lipid. This structured vocabulary will facilitate the systematization of lipid biology and enable the cataloging of lipids and their properties in a way that is compatible with other macromolecular databases.

  5. Model-Based Methods in the Biopharmaceutical Process Lifecycle.

    Science.gov (United States)

    Kroll, Paul; Hofer, Alexandra; Ulonska, Sophia; Kager, Julian; Herwig, Christoph

    2017-12-01

    Model-based methods are increasingly used in all areas of biopharmaceutical process technology. They can be applied in the field of experimental design, process characterization, process design, monitoring and control. Benefits of these methods are lower experimental effort, process transparency, clear rationality behind decisions and increased process robustness. The possibility of applying methods adopted from different scientific domains accelerates this trend further. In addition, model-based methods can help to implement regulatory requirements as suggested by recent Quality by Design and validation initiatives. The aim of this review is to give an overview of the state of the art of model-based methods, their applications, further challenges and possible solutions in the biopharmaceutical process life cycle. Today, despite these advantages, the potential of model-based methods is still not fully exhausted in bioprocess technology. This is due to a lack of (i) acceptance of the users, (ii) user-friendly tools provided by existing methods, (iii) implementation in existing process control systems and (iv) clear workflows to set up specific process models. We propose that model-based methods be applied throughout the lifecycle of a biopharmaceutical process, starting with the set-up of a process model, which is used for monitoring and control of process parameters, and ending with continuous and iterative process improvement via data mining techniques.

  6. Evaluation of the subaxial injury classification system

    Directory of Open Access Journals (Sweden)

    A F Joaquim

    2011-01-01

    Full Text Available Study design : Retrospective clinical study of patients treated for subaxial cervical spine trauma (SCST at a tertiary medical center. Purpose : Evaluate the validity of the Subaxial Injury Classification (SLIC system in surgical versus non-surgical decision making for SCST. Inclusion criteria : Age >12 years, presence of SCST with complete clinical and radiological (CT and MRI data. Exclusion criteria : Patients with incomplete radiographic or clinical data, pathological fractures, isolated upper cervical trauma (occiput to C2, isolated transverse process or spinous process fractures, chronic or age indeterminate fractures, isolate MRI findings, and severe systemic trauma with death prior to either surgical or non-surgical treatment. Results : Fourteen patients were treated non-surgically (C, whereas 24 were treated surgically (S. In the C group, the SLIC score ranged from 0 to 5 points (standard deviation [SD] = 1.20 points; mean 1.07; median 1. Just 1 patient had an SLIC score greater than 2 (7.1% of the patients. In the S group, the SLIC score ranged from 1 to 10 points (standard deviation [SD] = 2.03 points; mean 5.6; median 6. Just 2 patients had an SLIC score smaller than 4 (both with 1 point each, 8.3% of the total group. All the other 22 (accounting for 91.6% patients had an SLIC of 4 or more points. Conclusions : Our study suggests that the SLIC classification looks to be a promising system to aid spinal surgeons in the decision-making process of subaxial cervical trauma, but a large prospective cohort study is required.

  7. BDDCS Predictions, Self-Correcting Aspects of BDDCS Assignments, BDDCS Assignment Corrections, and Classification for more than 175 Additional Drugs.

    Science.gov (United States)

    Hosey, Chelsea M; Chan, Rosa; Benet, Leslie Z

    2016-01-01

    The biopharmaceutics drug disposition classification system was developed in 2005 by Wu and Benet as a tool to predict metabolizing enzyme and drug transporter effects on drug disposition. The system was modified from the biopharmaceutics classification system and classifies drugs according to their extent of metabolism and their water solubility. By 2010, Benet et al. had classified over 900 drugs. In this paper, we incorporate more than 175 drugs into the system and amend the classification of 13 drugs. We discuss current and additional applications of BDDCS, which include predicting drug-drug and endogenous substrate interactions, pharmacogenomic effects, food effects, elimination routes, central nervous system exposure, toxicity, and environmental impacts of drugs. When predictions and classes are not aligned, the system detects an error and is able to self-correct, generally indicating a problem with initial class assignment and/or measurements determining such assignments.

  8. Bioanalytical LC-MS/MS of protein-based biopharmaceuticals

    NARCIS (Netherlands)

    Broek, I. van den; Niessen, W.M.A.; Dongen, W.D. van

    2013-01-01

    Biotechnology increasingly delivers highly promising protein-based biopharmaceutical candidates to the drug development funnel. For successful biopharmaceutical drug development, reliable bioanalytical methods enabling quantification of drugs in biological fluids (plasma, urine, tissue, etc.) are

  9. A proposed data base system for detection, classification and ...

    African Journals Online (AJOL)

    A proposed data base system for detection, classification and location of fault on electricity company of Ghana electrical distribution system. Isaac Owusu-Nyarko, Mensah-Ananoo Eugine. Abstract. No Abstract. Keywords: database, classification of fault, power, distribution system, SCADA, ECG. Full Text: EMAIL FULL TEXT ...

  10. Determination of a radioactive waste classification system

    Energy Technology Data Exchange (ETDEWEB)

    Cohen, J.J.; King, W.C.

    1978-03-01

    Several classification systems for radioactive wastes are reviewed and a system is developed that provides guidance on disposition of the waste. The system has three classes: high-level waste (HLW), which requires complete isolation from the biosphere for extended time periods; low-level waste (LLW), which requires containment for shorter periods; and innocuous waste (essentially nonradioactive), which may be disposed of by conventional means. The LLW/innocuous waste interface was not defined in this study. Reasonably conservative analytical scenarios were used to calculate that HLW/LLW interface level which would ensure compliance with the radiological exposure guidelines of 0.5 rem/y maximum exposure for a few isolated individuals and 0.005 rem/y for large population groups. The recommended HLW/LLW interface level for /sup 239/Pu or mixed transuranic waste is 1.0 ..mu..Ci/cm/sup 3/ of waste. Levels for other radionuclides are based upon a risk equivalent to this level. A cost-benefit analysis in accordance with as low as reasonably achievable (ALARA) and National Environmental Protection Act (NEPA) guidance indicates that further reduction of this HLW/LLL interface level would entail marginal costs greater than $10/sup 8/ per man-rem of dose avoided. The environmental effects considered were limited to those involving human exposure to radioactivity.

  11. Determination of a radioactive waste classification system

    International Nuclear Information System (INIS)

    Cohen, J.J.; King, W.C.

    1978-03-01

    Several classification systems for radioactive wastes are reviewed and a system is developed that provides guidance on disposition of the waste. The system has three classes: high-level waste (HLW), which requires complete isolation from the biosphere for extended time periods; low-level waste (LLW), which requires containment for shorter periods; and innocuous waste (essentially nonradioactive), which may be disposed of by conventional means. The LLW/innocuous waste interface was not defined in this study. Reasonably conservative analytical scenarios were used to calculate that HLW/LLW interface level which would ensure compliance with the radiological exposure guidelines of 0.5 rem/y maximum exposure for a few isolated individuals and 0.005 rem/y for large population groups. The recommended HLW/LLW interface level for 239 Pu or mixed transuranic waste is 1.0 μCi/cm 3 of waste. Levels for other radionuclides are based upon a risk equivalent to this level. A cost-benefit analysis in accordance with as low as reasonably achievable (ALARA) and National Environmental Protection Act (NEPA) guidance indicates that further reduction of this HLW/LLL interface level would entail marginal costs greater than $10 8 per man-rem of dose avoided. The environmental effects considered were limited to those involving human exposure to radioactivity

  12. Marginalization and Exclusion: Unraveling Systemic Bias in Classification

    DEFF Research Database (Denmark)

    Mai, Jens-Erik

    2016-01-01

    This paper explores the knowledge organization landscape in which Hope Olson’s numerous contri- butions to the field are situated. The paper first explores some of the foundational conceptual notions within knowledge organization that today are well-accepted. The paper then reviews Hope Olson...... in large library classification has unraveled the systemic bias found in all classifications. The paper calls for stronger engagement between scholarship and practice to ad- dress marginalization and exclusion in further work on classification systems....

  13. Review of international classification systems for uranium resources

    International Nuclear Information System (INIS)

    Wang Wenyou

    2007-01-01

    The two primary classification systems for uranium resources in common use in the whole world are described. These uranium resource classification systems were developed under two distinct philosophies, it implies two very different processes, criteria, terms and definitions from which the systems evolved and were implemented. However, the two primary systems are all based on two considerations: the degree of geological confidence and the degree of economic attractiveness based on cost of producing the resource. The uranium resource classification methods currently used in most major uranium producing countries have all a bearing on the two aforesaid classification systems. The disparity exists only in the way or practice of classifying and estimating the uranium resources for reasons of different political and economical systems in various countries. The harmonization of these resource classification systems for uranium can be realized with the economic integration on a global scale. (authors)

  14. Risk-based classification system of nanomaterials

    International Nuclear Information System (INIS)

    Tervonen, Tommi; Linkov, Igor; Figueira, Jose Rui; Steevens, Jeffery; Chappell, Mark; Merad, Myriam

    2009-01-01

    Various stakeholders are increasingly interested in the potential toxicity and other risks associated with nanomaterials throughout the different stages of a product's life cycle (e.g., development, production, use, disposal). Risk assessment methods and tools developed and applied to chemical and biological materials may not be readily adaptable for nanomaterials because of the current uncertainty in identifying the relevant physico-chemical and biological properties that adequately describe the materials. Such uncertainty is further driven by the substantial variations in the properties of the original material due to variable manufacturing processes employed in nanomaterial production. To guide scientists and engineers in nanomaterial research and application as well as to promote the safe handling and use of these materials, we propose a decision support system for classifying nanomaterials into different risk categories. The classification system is based on a set of performance metrics that measure both the toxicity and physico-chemical characteristics of the original materials, as well as the expected environmental impacts through the product life cycle. Stochastic multicriteria acceptability analysis (SMAA-TRI), a formal decision analysis method, was used as the foundation for this task. This method allowed us to cluster various nanomaterials in different ecological risk categories based on our current knowledge of nanomaterial physico-chemical characteristics, variation in produced material, and best professional judgments. SMAA-TRI uses Monte Carlo simulations to explore all feasible values for weights, criteria measurements, and other model parameters to assess the robustness of nanomaterial grouping for risk management purposes.

  15. Classification of parotidectomy: a proposed modification to the European Salivary Gland Society classification system.

    Science.gov (United States)

    Wong, Wai Keat; Shetty, Subhaschandra

    2017-08-01

    Parotidectomy remains the mainstay of treatment for both benign and malignant lesions of the parotid gland. There exists a wide range of possible surgical options in parotidectomy in terms of extent of parotid tissue removed. There is increasing need for uniformity of terminology resulting from growing interest in modifications of the conventional parotidectomy. It is, therefore, of paramount importance for a standardized classification system in describing extent of parotidectomy. Recently, the European Salivary Gland Society (ESGS) proposed a novel classification system for parotidectomy. The aim of this study is to evaluate this system. A classification system proposed by the ESGS was critically re-evaluated and modified to increase its accuracy and its acceptability. Modifications mainly focused on subdividing Levels I and II into IA, IB, IIA, and IIB. From June 2006 to June 2016, 126 patients underwent 130 parotidectomies at our hospital. The classification system was tested in that cohort of patient. While the ESGS classification system is comprehensive, it does not cover all possibilities. The addition of Sublevels IA, IB, IIA, and IIB may help to address some of the clinical situations seen and is clinically relevant. We aim to test the modified classification system for partial parotidectomy to address some of the challenges mentioned.

  16. Classification process in a text document recommender system

    Directory of Open Access Journals (Sweden)

    Dan MUNTEANU

    2005-12-01

    Full Text Available This paper presents the classification process in a recommender system used for textual documents taken especially from web. The system uses in the classification process a combination of content filters, event filters and collaborative filters and it uses implicit and explicit feedback for evaluating documents.

  17. Designing a Classification System for Internet Offenders: Doing Cognitive Distortions

    Science.gov (United States)

    Hundersmarck, Steven F.; Durkin, Keith F.; Delong, Ronald L.

    2007-01-01

    Televised features such as NBC's "To Catch a Predator" have highlighted the growing problem posed by Internet sexual predators. This paper reports on the authors' attempts in designing a classification system for Internet offenders. The classification system was designed based on existing theory, understanding the nature of Internet offenders and…

  18. Classification System of Pathological Voices Using Correntropy

    Directory of Open Access Journals (Sweden)

    Aluisio I. R. Fontes

    2014-01-01

    Full Text Available This paper proposes the use of a similarity measure based on information theory called correntropy for the automatic classification of pathological voices. By using correntropy, it is possible to obtain descriptors that aggregate distinct spectral characteristics for healthy and pathological voices. Experiments using computational simulation demonstrate that such descriptors are very efficient in the characterization of vocal dysfunctions, leading to a success rate of 97% in the classification. With this new architecture, the classification process of vocal pathologies becomes much more simple and efficient.

  19. Safety classification of nuclear power plant systems, structures and components

    International Nuclear Information System (INIS)

    1992-01-01

    The Safety Classification principles used for the systems, structures and components of a nuclear power plant are detailed in the guide. For classification, the nuclear power plant is divided into structural and operational units called systems. Every structure and component under control is included into some system. The Safety Classes are 1, 2 and 3 and the Class EYT (non-nuclear). Instructions how to assign each system, structure and component to an appropriate safety class are given in the guide. The guide applies to new nuclear power plants and to the safety classification of systems, structures and components designed for the refitting of old nuclear power plants. The classification principles and procedures applying to the classification document are also given

  20. A novel classification system for aging theories

    Directory of Open Access Journals (Sweden)

    Lucas Siqueira Trindade

    2013-03-01

    Full Text Available Theories of lifespan evolution are a source of confusion amongst aging researchers. After a century of aging research the dispute over whether the aging process is active or passive persists and a comprehensive and universally accepted theoretical model remains elusive. Evolutionary aging theories primarily dispute whether the aging process is exclusively adapted to favor the kin or exclusively non-adapted to favor the individual. Interestingly, contradictory data and theories supporting both exclusively programmed and exclusively non-programmed theories continue to grow. However, this is a false dichotomy; natural selection favors traits resulting in efficient reproduction whether they benefit the individual or the kin. Thus, to understand the evolution of aging, first we must understand the environment-dependent balance between the advantages and disadvantages of extended lifespan in the process of spreading genes. As described by distinct theories, different niches and environmental conditions confer on extended lifespan a range of fitness values varying from highly beneficial to highly detrimental. Here, we considered the range of fitness values for extended lifespan and develop a fitness-based framework for categorizing existing theories. We show that all theories can be classified into four basic types: secondary (beneficial, maladaptive (neutral, assisted death (detrimental and senemorphic aging (varying between beneficial to detrimental. We anticipate that this classification system will assist with understanding and interpreting aging/death by providing a way of considering theories as members of one of these classes rather than consideration of their individual details.

  1. A fast fault classification technique for power systems

    OpenAIRE

    Nouri, H.; Wang, C.; Power Systems, Electronics and Control Research Lab

    2014-01-01

    This paper proposes a fast fault classification technique using three phase current signals for power systems. Digital Fourier Transform, the ‘Least Square’ method or the Kalman Filtering technique are used to extract fundamental frequency components of three phase fault currents. Fast fault classification can be achieved using the fault probability of three phases. Results from simulation work on EMTP have validated the proposed fault classification technique. The response time of the fault ...

  2. Update of the LIPID MAPS comprehensive classification system for lipids.

    Science.gov (United States)

    Fahy, Eoin; Subramaniam, Shankar; Murphy, Robert C; Nishijima, Masahiro; Raetz, Christian R H; Shimizu, Takao; Spener, Friedrich; van Meer, Gerrit; Wakelam, Michael J O; Dennis, Edward A

    2009-04-01

    In 2005, the International Lipid Classification and Nomenclature Committee under the sponsorship of the LIPID MAPS Consortium developed and established a "Comprehensive Classification System for Lipids" based on well-defined chemical and biochemical principles and using an ontology that is extensible, flexible, and scalable. This classification system, which is compatible with contemporary databasing and informatics needs, has now been accepted internationally and widely adopted. In response to considerable attention and requests from lipid researchers from around the globe and in a variety of fields, the comprehensive classification system has undergone significant revisions over the last few years to more fully represent lipid structures from a wider variety of sources and to provide additional levels of detail as necessary. The details of this classification system are reviewed and updated and are presented here, along with revisions to its suggested nomenclature and structure-drawing recommendations for lipids.

  3. Advanced monitoring and control in biopharmaceutical production

    NARCIS (Netherlands)

    Soons, Z.I.T.A.

    2008-01-01

    Bioprocesses are characterised by natural variability in raw materials, initial conditions, human intervention, and varying properties of the micro-organism. In traditional biopharmaceutical production quality of the product is currently tested at the end of the production process only. Recently the

  4. Comparative evaluation of the biopharmaceutical and chemical ...

    African Journals Online (AJOL)

    Method: The biopharmaceutical and chemical equivalence of ten brands of ciprofloxacin hydrochloride tablets were assessed through the evaluation of the uniformity of weight, friability test, hardness, disintegration test, dissolution rate, thin layer chromatography and non-aqueous titration procedure with the use of crystal ...

  5. Pharmaceutical technology, biopharmaceutics and drug delivery.

    Science.gov (United States)

    Youn, Yu Seok; Lee, Beom-Jin

    2011-03-01

    The 40th annual international conference of the Korean Society of Pharmaceutical Sciences and Technology on Pharmaceutical Technology, Biopharmaceutics and Drug Delivery was held on 2-3 December 2010 in Jeju Special Self-Governing Providence, Korea, to celebrate its 40th anniversary. A comprehensive review of a wide spectrum of recent topics on pharmaceutical technology, biopharmaceutics and drug delivery was presented. Invited lectures and poster presentations over 2 days were divided into six parallel sessions covering areas such as biotechnology, biopharmaceutics, drug delivery, formulation/manufacture, regulatory science and frontier science. Among these, there were two sessions related to regulatory science and biopharmaceutics that were co-sponsored by the Korea Food and Drug Administration. In fact, this conference provided an opportunity for many investigators to discuss their research, collect new information and to promote the advancement of knowledge in each pharmaceutical area. This conference report summarizes the keynote podium presentations provided by many distinguished speakers, including Gordon L Amidon of the University of Michigan.

  6. [Biopharmaceuticals in the treatment of rheumatoid arthritis

    DEFF Research Database (Denmark)

    Baslund, B.; Bendtzen, K.

    2008-01-01

    The current status on the use of biopharmaceuticals in the treatment of rheumatoid arthritis is reviewed. Blocking of TNF-alpha, co-stimulation of CD28+ T-cells and depletion of CD20+ B-cells are all effective ways to diminish inflammation and joint damage. However, not all patients react...

  7. New C2 synchondrosal fracture classification system

    Energy Technology Data Exchange (ETDEWEB)

    Rusin, Jerome A.; Ruess, Lynne [Department of Radiology, Nationwide Children' s Hospital, Columbus, OH (United States); The Ohio State University College of Medicine and Public Health, Columbus, OH (United States); Daulton, Robert S. [Department of Radiology, Nationwide Children' s Hospital, Columbus, OH (United States)

    2015-06-15

    Excessive cervical flexion-extension accompanying mild to severe impact injuries can lead to C2 synchondrosal fractures in young children. To characterize and classify C2 synchondrosal fracture patterns. We retrospectively reviewed imaging and medical records of children who were treated for cervical spine fractures at our institution between 1995 and 2014. We reviewed all fractures involving the five central C2 synchondroses with regard to patient demographics, mechanism of injury, fracture pattern, associated fractures and other injuries, treatment plans and outcome. Fourteen children had fractures involving the central C2 synchondroses. There were nine boys and five girls, all younger than 6 years. We found four distinct fracture patterns. Eleven complete fractures were further divided into four subtypes (a, b, c and d) based on degree of anterior displacement of the odontoid segment and presence of distraction. Nine of these 11 children had fractures through both odontoneural synchondroses and the odontocentral synchondrosis; one had fractures involving both neurocentral synchondroses and the odontoneural synchondrosis; one had fractures through bilateral odontoneural and bilateral neurocentral synchondroses. Three children had incomplete fractures, defined as a fracture through a single odontoneural synchondrosis with or without partial extension into either the odontocentral or the adjacent neurocentral synchondroses. All complete fractures were displaced or angulated. Four had associated spinal cord injury, including two contusions (subtype c fractures) and two fatal transections (subtype d fractures). Most children were treated with primary halo stabilization. Subtype c fractures required surgical fixation. We describe four patterns of central C2 synchondrosal fractures, including two unique patterns that have not been reported. We propose a classification system to distinguish these fractures and aid in treatment planning. (orig.)

  8. A juice extractor can simplify the downstream processing of plant-derived biopharmaceutical proteins compared to blade-based homogenizers

    OpenAIRE

    Buyel, J.F.; Fischer, R.

    2015-01-01

    The production of biopharmaceutical proteins using plant-based systems has recently become economically competitive with conventional expression platforms based on microbes and mammalian cells, but downstream processing remains a significant cost factor. Here we report that, depending on the protein expression level, production costs for biopharmaceuticals made in plants can be reduced by up to 30% if a juice extractor is used instead of a blade-based homogenizer or blender. Although the extr...

  9. Calibration of a Plastic Classification System with the Ccw Model

    International Nuclear Information System (INIS)

    Barcala Riveira, J. M.; Fernandez Marron, J. L.; Alberdi Primicia, J.; Navarrete Marin, J. J.; Oller Gonzalez, J. C.

    2003-01-01

    This document describes the calibration of a plastic Classification system with the Ccw model (Classification by Quantum's built with Wavelet Coefficients). The method is applied to spectra of plastics usually present in domestic wastes. Obtained results are showed. (Author) 16 refs

  10. A consumer-oriented classification system for home meal replacements

    NARCIS (Netherlands)

    Costa, A.I.A.; Dekker, M.; Beumer, R.R.; Rombouts, F.M.; Jongen, W.M.F.

    2001-01-01

    This paper introduces a new definition and classification system for home meal replacements (HMR), based on convenience attributes as viewed by consumers. An overview of other food classifications, focusing on methodological aspects, is also presented. The classifying criteria chosen (shelf-life and

  11. Update of the LIPID MAPS comprehensive classification system for lipids

    NARCIS (Netherlands)

    Fahy, E.; Subramaniam, S.; Murphy, R.C.; Nishijima, M.; Raetz, C.R.H.; Shimizu, T.; Spener, F.; van Meer, G.|info:eu-repo/dai/nl/068570368; Wakelam, M.J.O.; Dennis, E.A.

    2009-01-01

    In 2005, the International Lipid Classification and Nomenclature Committee under the sponsorship of the LIPID MAPS Consortium developed and established a “Comprehensive Classification System for Lipids” based on well-defined chemical and biochemical principles and using an ontology that is

  12. EPUAP classification system for pressure ulcers: European reliability study.

    NARCIS (Netherlands)

    Beeckman, D.; Schoonhoven, L.; Fletcher, J.; Furtado, K.; Gunningberg, L.; Heyman, H.; Lindholm, C.; Paquay, L.; Verdu, J.; Defloor, T.

    2007-01-01

    AIM: This paper is a report of a study of the inter-observer reliability of the European Pressure Ulcer Advisory Panel pressure ulcer classification system and of the differential diagnosis between moisture lesions and pressure ulcers. BACKGROUND: Pressure ulcer classification is a valuable tool to

  13. Development of a classification system for periodontal diseases and conditions.

    Science.gov (United States)

    Armitage, G C

    2000-01-01

    Classification systems are necessary in order to provide a framework in which to scientifically study the etiology, pathogenesis, and treatment of diseases in an orderly fashion. In addition, such systems give clinicians a way to organize the health care needs of their patients. The last time scientists and clinicians in the field of periodontology and related areas agreed upon a classification system for periodontal diseases was in 1989 at the World Workshop in Clinical Periodontics. Subsequently, a simpler classification was agreed upon at the 1st European Workshop in Periodontology. These classification systems have been widely used by clinicians and research scientists throughout the world. Unfortunately, the 1989 classification had many shortcomings, including: (1) considerable overlap in disease categories, (2) absence of a gingival disease component, (3) inappropriate emphasis on age of onset of disease and rates of progression, and (4) inadequate or unclear classification criteria. The 1993 European classification lacked the detail necessary for adequate characterization of the broad spectrum of periodontal diseases encountered in clinical practice. The need for a revised classification system for periodontal diseases was emphasized during the 1996 World Workshop in Periodontics. In 1997 the American Academy of Periodontology responded to this need and formed a committee to plan and organize an international workshop to revise the classification system for periodontal diseases. The proceedings in this volume are the result of this reclassification effort. The process involved development by the Organizing Committee of an outline for a new classification and identification of individuals to write state-of-the-science reviews for each of the items on the outline. The reviewers were encouraged to depart from the preliminary outline if there were data to support any modifications. On October 30-November 2, 1999, the International Workshop for a Classification

  14. The theory and practice of the Dewey Decimal Classification system

    CERN Document Server

    Satija, M P

    2013-01-01

    The Dewey Decimal Classification system (DDC) is the world's most popular library classification system. The 23rd edition of the DDC was published in 2011. This second edition of The Theory and Practice of the Dewey Decimal Classification System examines the history, management and technical aspects of the DDC up to its latest edition. The book places emphasis on explaining the structure and number building techniques in the DDC and reviews all aspects of subject analysis and number building by the most recent version of the DDC. A history of, and introduction to, the DDC is followed by subjec

  15. Regional intestinal drug permeation: biopharmaceutics and drug development.

    Science.gov (United States)

    Lennernäs, Hans

    2014-06-16

    Over the last 25 years, profound changes have been seen in both the development and regulation of pharmaceutical dosage forms, due primarily to the extensive use of the biopharmaceutical classification system (BCS) in both academia and industry. The BCS and the FDA scale-up and post-approval change guidelines were both developed during the 1990s and both are currently widely used to claim biowaivers. The development of the BCS and its wide acceptance were important steps in pharmaceutical science that contributed to the more rational development of oral dosage forms. The effective permeation (Peff) of drugs through the intestine often depends on the combined outcomes of passive diffusion and multiple parallel transport processes. Site-specific jejunal Peff cannot reflect the permeability of the whole intestinal tract, since this varies along the length of the intestine, but is a useful approximation of the fraction of the oral dose that is absorbed. It appears that drugs with a jejunal Peff>1.5×10(-4)cm/s will be completely absorbed no matter which transport mechanisms are utilized. In this paper, historical clinical data originating from earlier open, single-pass perfusion studies have been used to calculate the Peff of different substances from sites in the jejunum and ileum. More exploratory in vivo studies are required in order to obtain reliable data on regional intestinal drug absorption. The development of experimental and theoretical methods of assessing drug absorption from both small intestine and various sites in the colon is encouraged. Some of the existing human in vivo data are discussed in relation to commonly used cell culture models. It is crucial to accurately determine the input parameters, such as the regional intestinal Peff, as these will form the basis for the expected increase in modeling and simulation of all the processes involved in GI drug absorption, thus facilitating successful pharmaceutical development in the future. It is suggested

  16. Development of a classification system for cup anemometers - CLASSCUP

    DEFF Research Database (Denmark)

    Friis Pedersen, Troels

    2003-01-01

    classification system. A classification method for cup anemometers has been developed, which proposes general external operational ranges to be used. Anormal category range connected to ideal sites of the IEC power performance standard was made, and another extended category range for complex terrain...... the objectives to quantify the errors associated with the use of cup anemometers, and to determine the requirements for an optimum design of a cup anemometer, and to develop a classification system forquantification of systematic errors of cup anemometers. The present report describes this proposed...... was proposed. General classification indices were proposed for all types of cup anemometers. As a resultof the classification, the cup anemometer will be assigned to a certain class: 0.5, 1, 2, 3 or 5 with corresponding intrinsic errors (%) as a vector instrument (3D) or as a horizontal instrument (2D...

  17. Formulation Strategies and Particle Engineering Technologies for Pulmonary Delivery of Biopharmaceuticals

    DEFF Research Database (Denmark)

    Cun, Dongmei; Wan, Feng; Yang, Mingshi

    2015-01-01

    remains the most significant challeng to their clinical adoption due to their unfavorable intrinsic physicochemical properties. Among noninvasive administration routes the lung has been attempted intensively to be an alternative to injection to deliver the biopharmaceuticals, and has shown to be promising....... In this review we discussed the formulation strategies and particle engineering technologies to improve the efficiency of pulmonary delivery of biopharmaceutical, with a focus on systemic therapy of pharmaceutical proteins/peptides and local delivery of siRNA via the lung administration....

  18. Prediction of solubility and permeability class membership: provisional BCS classification of the world's top oral drugs.

    Science.gov (United States)

    Dahan, Arik; Miller, Jonathan M; Amidon, Gordon L

    2009-12-01

    The Biopharmaceutics Classification System (BCS) categorizes drugs into one of four biopharmaceutical classes according to their water solubility and membrane permeability characteristics and broadly allows the prediction of the rate-limiting step in the intestinal absorption process following oral administration. Since its introduction in 1995, the BCS has generated remarkable impact on the global pharmaceutical sciences arena, in drug discovery, development, and regulation, and extensive validation/discussion/extension of the BCS is continuously published in the literature. The BCS has been effectively implanted by drug regulatory agencies around the world in setting bioavailability/bioequivalence standards for immediate-release (IR) oral drug product approval. In this review, we describe the BCS scientific framework and impact on regulatory practice of oral drug products and review the provisional BCS classification of the top drugs on the global market. The Biopharmaceutical Drug Disposition Classification System and its association with the BCS are discussed as well. One notable finding of the provisional BCS classification is that the clinical performance of the majority of approved IR oral drug products essential for human health can be assured with an in vitro dissolution test, rather than empirical in vivo human studies.

  19. Cirse Quality Assurance Document and Standards for Classification of Complications: The Cirse Classification System.

    Science.gov (United States)

    Filippiadis, D K; Binkert, C; Pellerin, O; Hoffmann, R T; Krajina, A; Pereira, P L

    2017-08-01

    Interventional radiology provides a wide variety of vascular, nonvascular, musculoskeletal, and oncologic minimally invasive techniques aimed at therapy or palliation of a broad spectrum of pathologic conditions. Outcome data for these techniques are globally evaluated by hospitals, insurance companies, and government agencies targeting in a high-quality health care policy, including reimbursement strategies. To analyze effectively the outcome of a technique, accurate reporting of complications is necessary. Throughout the literature, numerous classification systems for complications grading and classification have been reported. Until now, there has been no method for uniform reporting of complications both in terms of definition and grading. The purpose of this CIRSE guideline is to provide a classification system of complications based on combining outcome and severity of sequelae. The ultimate challenge will be the adoption of this system by practitioners in different countries and health economies within the European Union and beyond.

  20. Classification systems and selection systems: the risks of radical innovation and category spanning

    NARCIS (Netherlands)

    Wijnberg, N.M.

    2011-01-01

    This paper looks at the relations between classification and competition, using the theoretical framework of selection system theory. In a particular competitive arena more than one classification system can be in use. The proportion of classification systems in use by consumers that are also in use

  1. Marginalization and Exclusion: Unraveling Systemic Bias in Classification

    DEFF Research Database (Denmark)

    Mai, Jens-Erik

    2016-01-01

    This paper explores the knowledge organization landscape in which Hope Olson’s numerous contri- butions to the field are situated. The paper first explores some of the foundational conceptual notions within knowledge organization that today are well-accepted. The paper then reviews Hope Olson’s c...... in large library classification has unraveled the systemic bias found in all classifications. The paper calls for stronger engagement between scholarship and practice to ad- dress marginalization and exclusion in further work on classification systems....

  2. A simplified classification system for partially edentulous spaces

    Directory of Open Access Journals (Sweden)

    Bhandari Aruna J, Bhandari Akshay J

    2014-04-01

    Full Text Available Background: There is no single universally employed classification system that will specify the exact edentulous situation. Several classification systems exist to group the situation and avoid confusion. Classifications based on edentulous areas, finished restored prostheses, type of direct retainers or fulcrum lines are there. Some are based depending on the placement of the implants. Widely accepted Kennedy Applegate classification does not give any idea about length, span or number of teeth missing. Rule 6 governing the application of Kennedy method states that additional edentulous areas are referred as modification number 1,2 etc. Rule 7 states that extent of the modification is not considered; only the number of edentulous areas is considered. Hence there is a need to modify the Kennedy –Applegate System. Aims: This new classification system is an attempt to modify Kennedy –Applegate System so as to give the exact idea about missing teeth, space, span, side and areas of partially edentulous arches. Methods and Material: This system will provide the information regarding Maxillary or Mandibular partially edentulous arches, Left or Right side, length of the edentulous space, number of teeth missing and whether there will be tooth borne or tooth – tissue borne prosthesis. Conclusions: This classification is easy for application, communication and will also help to design the removable cast partial denture in a better logical and systematic way. Also, this system will give the idea of the edentulous status and the number of missing teeth in fixed, hybrid or implant prosthesis.

  3. Classification System of Pathological Voices Using Correntropy

    OpenAIRE

    Aluisio I. R. Fontes; Pedro T. V. Souza; Adrião D. D. Neto; Allan de M. Martins; Luiz F. Q. Silveira

    2014-01-01

    This paper proposes the use of a similarity measure based on information theory called correntropy for the automatic classification of pathological voices. By using correntropy, it is possible to obtain descriptors that aggregate distinct spectral characteristics for healthy and pathological voices. Experiments using computational simulation demonstrate that such descriptors are very efficient in the characterization of vocal dysfunctions, leading to a success rate of 97% in the classificatio...

  4. Formalization of the classification pattern: survey of classification modeling in information systems engineering.

    Science.gov (United States)

    Partridge, Chris; de Cesare, Sergio; Mitchell, Andrew; Odell, James

    2018-01-01

    Formalization is becoming more common in all stages of the development of information systems, as a better understanding of its benefits emerges. Classification systems are ubiquitous, no more so than in domain modeling. The classification pattern that underlies these systems provides a good case study of the move toward formalization in part because it illustrates some of the barriers to formalization, including the formal complexity of the pattern and the ontological issues surrounding the "one and the many." Powersets are a way of characterizing the (complex) formal structure of the classification pattern, and their formalization has been extensively studied in mathematics since Cantor's work in the late nineteenth century. One can use this formalization to develop a useful benchmark. There are various communities within information systems engineering (ISE) that are gradually working toward a formalization of the classification pattern. However, for most of these communities, this work is incomplete, in that they have not yet arrived at a solution with the expressiveness of the powerset benchmark. This contrasts with the early smooth adoption of powerset by other information systems communities to, for example, formalize relations. One way of understanding the varying rates of adoption is recognizing that the different communities have different historical baggage. Many conceptual modeling communities emerged from work done on database design, and this creates hurdles to the adoption of the high level of expressiveness of powersets. Another relevant factor is that these communities also often feel, particularly in the case of domain modeling, a responsibility to explain the semantics of whatever formal structures they adopt. This paper aims to make sense of the formalization of the classification pattern in ISE and surveys its history through the literature, starting from the relevant theoretical works of the mathematical literature and gradually shifting focus

  5. Language of Czech Medical Reports and Classification Systems in Medicine

    Czech Academy of Sciences Publication Activity Database

    Přečková, Petra

    2010-01-01

    Roč. 6, č. 1 (2010), s. 58-65 ISSN 1801-5603 R&D Projects: GA MŠk(CZ) 1M06014 Institutional research plan: CEZ:AV0Z10300504 Keywords : terminology, * synonyms * classification systems * thesaurus * nomenclature * electronic health record * interoperability * semantic interoperability * cardiology * atherosclerosis Subject RIV: IN - Informatics, Computer Science http://www.ejbi.org/en/ejbi/article/53-en-language-of-czech-medical-reports- and - classification -systems-in-medicine.html

  6. High-Throughput Process Development for Biopharmaceuticals.

    Science.gov (United States)

    Shukla, Abhinav A; Rameez, Shahid; Wolfe, Leslie S; Oien, Nathan

    2017-11-14

    The ability to conduct multiple experiments in parallel significantly reduces the time that it takes to develop a manufacturing process for a biopharmaceutical. This is particularly significant before clinical entry, because process development and manufacturing are on the "critical path" for a drug candidate to enter clinical development. High-throughput process development (HTPD) methodologies can be similarly impactful during late-stage development, both for developing the final commercial process as well as for process characterization and scale-down validation activities that form a key component of the licensure filing package. This review examines the current state of the art for HTPD methodologies as they apply to cell culture, downstream purification, and analytical techniques. In addition, we provide a vision of how HTPD activities across all of these spaces can integrate to create a rapid process development engine that can accelerate biopharmaceutical drug development. Graphical Abstract.

  7. Glyco-engineering for biopharmaceutical production in moss bioreactors

    Directory of Open Access Journals (Sweden)

    Eva L. Decker

    2014-07-01

    Full Text Available The production of recombinant biopharmaceuticals (pharmaceutical proteins is a strongly growing area in the pharmaceutical industry. While most products to date are produced in mammalian cell cultures, namely CHO cells, plant-based production systems gained increasing acceptance over the last years. Different plant systems have been established which are suitable for standardization and precise control of cultivation conditions, thus meeting the criteria for pharmaceutical production.The majority of biopharmaceuticals comprise glycoproteins. Therefore, differences in protein glycosylation between humans and plants have to be taken into account and plant-specific glycosylation has to be eliminated to avoid adverse effects on quality, safety and efficacy of the products.The basal land plant Physcomitrella patens (moss has been employed for the recombinant production of high-value therapeutic target proteins (e.g., Vascular Endothelial Growth Factor, Complement Factor H, monoclonal antibodies, Erythropoietin. Being genetically excellently characterized and exceptionally amenable for precise gene targeting via homologous recombination, essential steps for the optimization of moss as a bioreactor for the production of recombinant proteins have been undertaken.Here, we discuss the glyco-engineering approaches to avoid non-human N- and O-glycosylation on target proteins produced in moss bioreactors.

  8. Classification

    DEFF Research Database (Denmark)

    Hjørland, Birger

    2017-01-01

    This article presents and discusses definitions of the term “classification” and the related concepts “Concept/conceptualization,”“categorization,” “ordering,” “taxonomy” and “typology.” It further presents and discusses theories of classification including the influences of Aristotle...... and Wittgenstein. It presents different views on forming classes, including logical division, numerical taxonomy, historical classification, hermeneutical and pragmatic/critical views. Finally, issues related to artificial versus natural classification and taxonomic monism versus taxonomic pluralism are briefly...

  9. The market of biopharmaceutical medicines: A snapshot of a diverse industrial landscape

    NARCIS (Netherlands)

    Moorkens, E. (Evelien); Meuwissen, N. (Nicolas); Huys, I. (Isabelle); P.J. Declerck (Paul); A.G. Vulto (Arnold); S. Simoens (Steven)

    2017-01-01

    textabstractBackground: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market. Objectives: This study aims to identify

  10. Locust bean gum: Exploring its potential for biopharmaceutical applications.

    Science.gov (United States)

    Dionísio, Marita; Grenha, Ana

    2012-07-01

    Polysaccharides have been finding, in the last decades, very interesting and useful applications in the biomedical and, specifically, in the biopharmaceutical field. Locust bean gum is a polysaccharide belonging to the group of galactomannans, being extracted from the seeds of the carob tree (Ceratonia siliqua). This polymer displays a number of appealing characteristics for biopharmaceutical applications, among which its high gelling capacity should be highlighted. In this review, we describe critical aspects of locust bean gum, contributing for its role in biopharmaceutical applications. Physicochemical properties, as well as strong and effective synergies with other biomaterials are described. The potential for in vivo biodegradation is explored and the specific biopharmaceutical applications are discussed.

  11. Meta-language for land use classification systems

    CSIR Research Space (South Africa)

    Cooper, Antony K

    2014-04-01

    Full Text Available classification systems Antony K Cooper CSIR acooper@csir.co.za Development of an Interim Framework for the National Land Use Classification Standard, Methodology and Symbology for South Africa Protea Hotel, OR Tambo International Airport, 15 April 2014... on ontologies! • Ontology – the branch of metaphysics dealing with the nature of being • [Concise Oxford Dictionary, 8th Ed] – One aspect (of many!) of ontology in philosophy is to classify things • For assessing existence, essence, qualities, etc...

  12. Revised Soil Classification System for Coarse-Fine Mixtures

    KAUST Repository

    Park, Junghee

    2017-04-17

    Soil classification systems worldwide capture great physical insight and enable geotechnical engineers to anticipate the properties and behavior of soils by grouping them into similar response categories based on their index properties. Yet gravimetric analysis and data trends summarized from published papers reveal critical limitations in soil group boundaries adopted in current systems. In particular, current classification systems fail to capture the dominant role of fines on the mechanical and hydraulic properties of soils. A revised soil classification system (RSCS) for coarse-fine mixtures is proposed herein. Definitions of classification boundaries use low and high void ratios that gravel, sand, and fines may attain. This research adopts emax and emin for gravels and sands, and three distinctive void ratio values for fines: soft eF|10  kPa and stiff eF|1  MPa for mechanical response (at effective stress 10 kPa and 1 MPa, respectively), and viscous λ⋅eF|LL for fluid flow control, where λ=2log(LL−25) and eF|LL is the void ratio at the liquid limit. For classification purposes, these void ratios can be estimated from index properties such as particle shape, the coefficient of uniformity, and the liquid limit. Analytically computed and data-adjusted boundaries are soil-specific, in contrast with the Unified Soil Classification System (USCS). Threshold fractions for mechanical control and for flow control are quite distinct in the proposed system. Therefore, the RSCS uses a two-name nomenclature whereby the first letters identify the component(s) that controls mechanical properties, followed by a letter (shown in parenthesis) that identifies the component that controls fluid flow. Sample charts in this paper and a Microsoft Excel facilitate the implementation of this revised classification system.

  13. Classification system of the mineral reserves and resources of Ukraine

    International Nuclear Information System (INIS)

    Lovinyukov, V.I.

    1998-01-01

    This paper describes the system used to classify the resources and reserves of all minerals and fuels in Ukraine. The classification system is part of an official procedure determined by the Ukrainian State Commission on Reserves. Following preparation of resource estimates the results are registered with the State, which maintains an official inventory of all mineral resources. This paper compares the Ukrainian system to, and finds it compatible with the United Nations International Framework of resource classification. The UN system is based on economics of production and mineability. (author)

  14. Hierarchical system for content-based audio classification and retrieval

    Science.gov (United States)

    Zhang, Tong; Kuo, C.-C. Jay

    1998-10-01

    A hierarchical system for audio classification and retrieval based on audio content analysis is presented in this paper. The system consists of three stages. The audio recordings are first classical and segmented into speech, music, several types of environmental sounds, and silence, based on morphological and statistical analysis of temporal curves of the energy function, the average zero-crossing rate, and the fundamental frequency of audio signals. The first stage is called the coarse-level audio classification and segmentation. Then, environmental sounds are classified into finer classes such as applause, rain, birds' sound, etc., which is called the fine-level audio classification. The second stage is based on time-frequency analysis of audio signals and the use of the hidden Markov model (HMM) for classification. In the third stage, the query-by-example audio retrieval is implemented where similar sounds can be found according to the input sample audio. The way of modeling audio features with the hidden Markov model, the procedures of audio classification and retrieval, and the experimental results are described. It is shown that, with the proposed new system, audio recordings can be automatically segmented and classified into basic types in real time with an accuracy higher than 90%. Examples of audio fine classification and audio retrieval with the proposed HMM-based method are also provided.

  15. Breast density classification to reduce false positives in CADe systems.

    Science.gov (United States)

    Vállez, Noelia; Bueno, Gloria; Déniz, Oscar; Dorado, Julián; Seoane, José Antonio; Pazos, Alejandro; Pastor, Carlos

    2014-02-01

    This paper describes a novel weighted voting tree classification scheme for breast density classification. Breast parenchymal density is an important risk factor in breast cancer. Moreover, it is known that mammogram interpretation is more difficult when dense tissue is involved. Therefore, automated breast density classification may aid in breast lesion detection and analysis. Several classification methods have been compared and a novel hierarchical classification procedure of combined classifiers with linear discriminant analysis (LDA) is proposed as the best solution to classify the mammograms into the four BIRADS tissue classes. The classification scheme is based on 298 texture features. Statistical analysis to test the normality and homoscedasticity of the data was carried out for feature selection. Thus, only features that are influenced by the tissue type were considered. The novel classification techniques have been incorporated into a CADe system to drive the detection algorithms and tested with 1459 images. The results obtained on the 322 screen-film mammograms (SFM) of the mini-MIAS dataset show that 99.75% of samples were correctly classified. On the 1137 full-field digital mammograms (FFDM) dataset results show 91.58% agreement. The results of the lesion detection algorithms were obtained from modules integrated within the CADe system developed by the authors and show that using breast tissue classification prior to lesion detection leads to an improvement of the detection results. The tools enhance the detectability of lesions and they are able to distinguish their local attenuation without local tissue density constraints. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  16. U.S. Geological Survey Library classification system

    Science.gov (United States)

    Sasscer, R. Scott

    2000-01-01

    The U.S. Geological Survey Library classification system has been designed for earth science libraries. It is a tool for assigning call numbers to earth science and allied pure science materials in order to collect these materials into related subject groups on the library shelves and arrange them alphabetically by author and title. The classification can be used as a retrieval system to access materials through the subject and geographic numbers.The classification scheme has been developed over the years since 1904 to meet the ever-changing needs of increased specialization and the development of new areas of research in the earth sciences. The system contains seven schedules: Subject scheduleGeological survey schedule Earth science periodical scheduleGovernment document periodical scheduleGeneral science periodical schedule Earth science map schedule Geographic schedule Introduction provides detailed instructions on the construction of call numbers for works falling into the framework of the classification schedules.The tables following the introduction can be quickly accessed through the use of the newly expanded subject index.The purpose of this publication is to provide the earth science community with a classification and retrieval system for earth science materials, to offer sufficient explanation of its structure and use, and to enable library staff and clientele to classify or access research materials in a library collection.

  17. An intelligent temporal pattern classification system using fuzzy ...

    Indian Academy of Sciences (India)

    Classification has been an active area of research for many decades in data mining. Recently, there is ... system has been evaluated using University of California Irvine (UCI) Machine Learning Repos- itory Data Set .... UCI machine learning repository data set: Input to the TFMM-PSO system is referred from the bench mark ...

  18. Fuel Characteristic Classification System version 3.0: technical documentation

    Science.gov (United States)

    Susan J. Prichard; David V. Sandberg; Roger D. Ottmar; Ellen Eberhardt; Anne Andreu; Paige Eagle; Kjell. Swedin

    2013-01-01

    The Fuel Characteristic Classification System (FCCS) is a software module that records wildland fuel characteristics and calculates potential fire behavior and hazard potentials based on input environmental variables. The FCCS 3.0 is housed within the Integrated Fuels Treatment Decision Support System (Joint Fire Science Program 2012). It can also be run from command...

  19. The development of a classification system for inland aquatic ...

    African Journals Online (AJOL)

    2015-10-05

    Oct 5, 2015 ... bles (such as climate and broad-scale geomorphology) to group ..... sification system for application to the National Wetland. Inventory. This classification system is the result of a collaborative research effort between a number of aquatic/wetland .... By the end of the testing period, the project team was.

  20. Should the South African red meat classification system be revised ...

    African Journals Online (AJOL)

    The objective of this review was to determine whether the current South African red meat classification system still needs to be revised and changed or maintained. It also gives insight into the most significant challenges related to meat quality evaluation in this system. Red Meat Research and Development South Africa ...

  1. Towards a regional beef carcass classification system for Southern ...

    African Journals Online (AJOL)

    This is partly because the current beef carcass grading and classification systems used in the region value inappropriately carcasses from slow-maturing indigenous cattle breeds that are ideally suited to being marketed off natural pasture. The existing systems use carcass yield and quality attributes, but do not predict ...

  2. Classification system for reporting events involving human malfunctions

    DEFF Research Database (Denmark)

    Rasmussen, Jens; Pedersen, O.M.; Mancini, G.

    1981-01-01

    The report describes a set of categories for reporting indus-trial incidents and events involving human malfunction. The classification system aims at ensuring information adequate for improvement of human work situations and man-machine interface systems and for attempts to quantify "human error...

  3. Systems Operation Studies for Automated Guideway Transit Systems - Classification and Definition of AGT Systems

    Science.gov (United States)

    1980-02-01

    The report describes the development of an AGT classification structure. Five classes are defined based on three system characteristics: service type, minimum travelling unit capacity, and maximum operating velocity. The five classes defined are: Per...

  4. Classification system for reporting events involving human malfunctions

    International Nuclear Information System (INIS)

    Rasmussen, J.; Pedersen, O.M.; Mancini, G.; Carnino, A.; Griffon, M.; Gagnolet, P.

    1981-03-01

    The report describes a set of categories for reporting industrial incidents and events involving human malfunction. The classification system aims at ensuring information adequate for improvement of human work situations and man-machine interface systems and for attempts to quantify ''human error'' rates. The classification system has a multifacetted non-hierarchial structure and its compatibility with Ispra's ERDS classification is described. The collection of the information in general and for quantification purposes are discussed. 24 categories, 12 of which being human factors oriented, are listed with their respective subcategories, and comments are given. Underlying models of human data processes and their typical malfunctions and of a human decision sequence are described. (author)

  5. Classification system for reporting events involving human malfunctions

    International Nuclear Information System (INIS)

    Rasmussen, J.; Pedersen, O.M.; Mancini, G.

    1981-01-01

    The report describes a set of categories for reporting industrial incidents and events involving human malfunction. The classification system aims at ensuring information adequate for improvement of human work situations and man-machine interface systems and for attempts to quantify ''human error'' rates. The classification system has a multifacetted non-hierarchical structure and its compatibility with Ispra's ERDS classification is described. The collection of the information in general and for quantification purposes are discussed. 24 categories, 12 of which being human factors-oriented, are listed with their respective subcategories, and comments are given. Underlying models of human data process and their typical malfuntions and of a human decision sequence are described. The work reported is a joint contribution to the CSNI Group of Experts on Human Error Data and Assessment

  6. A classification system for tableting behaviors of binary powder mixtures

    Directory of Open Access Journals (Sweden)

    Changquan Calvin Sun

    2016-08-01

    Full Text Available The ability to predict tableting properties of a powder mixture from individual components is of both fundamental and practical importance to the efficient formulation development of tablet products. A common tableting classification system (TCS of binary powder mixtures facilitates the systematic development of new knowledge in this direction. Based on the dependence of tablet tensile strength on weight fraction in a binary mixture, three main types of tableting behavior are identified. Each type is further divided to arrive at a total of 15 sub-classes. The proposed classification system lays a framework for a better understanding of powder interactions during compaction. Potential applications and limitations of this classification system are discussed.

  7. Modified Mahalanobis Taguchi System for Imbalance Data Classification

    Directory of Open Access Journals (Sweden)

    Mahmoud El-Banna

    2017-01-01

    Full Text Available The Mahalanobis Taguchi System (MTS is considered one of the most promising binary classification algorithms to handle imbalance data. Unfortunately, MTS lacks a method for determining an efficient threshold for the binary classification. In this paper, a nonlinear optimization model is formulated based on minimizing the distance between MTS Receiver Operating Characteristics (ROC curve and the theoretical optimal point named Modified Mahalanobis Taguchi System (MMTS. To validate the MMTS classification efficacy, it has been benchmarked with Support Vector Machines (SVMs, Naive Bayes (NB, Probabilistic Mahalanobis Taguchi Systems (PTM, Synthetic Minority Oversampling Technique (SMOTE, Adaptive Conformal Transformation (ACT, Kernel Boundary Alignment (KBA, Hidden Naive Bayes (HNB, and other improved Naive Bayes algorithms. MMTS outperforms the benchmarked algorithms especially when the imbalance ratio is greater than 400. A real life case study on manufacturing sector is used to demonstrate the applicability of the proposed model and to compare its performance with Mahalanobis Genetic Algorithm (MGA.

  8. Biopharmaceutics, pharmacokinetics and pharmacodynamics of antituberculosis drugs.

    Science.gov (United States)

    Budha, Nageshwar R; Lee, Richard E; Meibohm, Bernd

    2008-01-01

    Tuberculosis (TB) is the leading cause of mortality due to a single infectious agent. The currently used combination drug regimens produce cure rates that exceed 95%, given good patient adherence during the multiple months treatment period. However the recent surge in HIV infections and the synergy between HIV and TB as well as the emergence of resistance resulted in an unforeseen increase in the number of TB cases, including multi-drug resistant (MDR) and extensively-drug resistant (XDR) forms of TB. Consequently, there is an urgent need to develop novel, fast acting antituberculosis drugs with high potency that can provide treatment options for all forms of TB. It is well known that the current TB drugs exhibit differences in their in vivo activity profile and these differences are largely determined by their pharmacodynamics (PD), i.e. intrinsic antibacterial activity, biopharmaceutical properties such as solubility and permeability, and pharmacokinetic (PK) properties such as drug exposure, tissue distribution, and protein binding. An understanding of the relationships among these properties is considered key for a rational use of antituberculosis therapeutics. The current review provides a comprehensive summary of physicochemical/biopharmaceutical, PK, and PD properties of currently used antituberculosis drugs and novel agents under development. Also, a brief review of PK/PD parameters of current TB drugs is given and properties of a desirable TB drug target and drug molecule are outlined. The information provided herewith may be useful in the optimization of biopharmaceutical and PK/PD characteristics in the development of novel TB therapeutics and in the design of optimal treatment regimens.

  9. Investigating investment in biopharmaceutical R&D

    Science.gov (United States)

    Carter, Percy H.; Berndt, Ernst R.; DiMasi, Joseph A.; Trusheim, Mark

    2016-01-01

    Recent studies have highlighted a reduction in projected financial returns associated with biopharmaceutical R&D, owing to decreased productivity, increases in costs and flattening revenue per new drug, prompting calls for dramatic revisions to R&D models. On the basis of previous financial modelling, the simplest hypothesis would be that new investment in such R&D should be minimal and focused on biologics in preference to small molecules, as the internal rate of return on investment for biologics projects has been reported to be higher. PMID:27616295

  10. Binary classification of real sequences by discrete-time systems

    Science.gov (United States)

    Kaliski, M. E.; Johnson, T. L.

    1979-01-01

    This paper considers a novel approach to coding or classifying sequences of real numbers through the use of (generally nonlinear) finite-dimensional discrete-time systems. This approach involves a finite-dimensional discrete-time system (which we call a real acceptor) in cascade with a threshold type device (which we call a discriminator). The proposed classification scheme and the exact nature of the classification problem are described, along with two examples illustrating its applicability. Suggested approaches for further research are given.

  11. The biopharmaceutical industry in China: history and future perspectives.

    Science.gov (United States)

    Gao, Kai; Wang, Junzhi

    2012-06-01

    Biopharmaceuticals reflect the rapid progress achieved in modern biomedical research. This area has also become one of the main criteria for assessing the development level of biotechnology for a particular country. Although it has been only three decades since the first biopharmaceutical, recombinant human insulin, was licensed by the US Food and Drug Administration, the biopharmaceutical industry has become the fastest growing, most dynamic and technology-intensive sector in the biomedical field. Since the licensing of recombinant human interferon α1b in 1989, the biopharmaceutical industry in China has gone through initial developments and gradually entered a period of rapid growth. This paper provides an overview of the status and development trends of biopharmaceuticals in China, and compares them with those observed in developed countries.

  12. Evolution and classification of the CRISPR-Cas systems

    Science.gov (United States)

    S. Makarova, Kira; H. Haft, Daniel; Barrangou, Rodolphe; J. J. Brouns, Stan; Charpentier, Emmanuelle; Horvath, Philippe; Moineau, Sylvain; J. M. Mojica, Francisco; I. Wolf, Yuri; Yakunin, Alexander F.; van der Oost, John; V. Koonin, Eugene

    2012-01-01

    The CRISPR–Cas (clustered regularly interspaced short palindromic repeats–CRISPR-associated proteins) modules are adaptive immunity systems that are present in many archaea and bacteria. These defence systems are encoded by operons that have an extraordinarily diverse architecture and a high rate of evolution for both the cas genes and the unique spacer content. Here, we provide an updated analysis of the evolutionary relationships between CRISPR–Cas systems and Cas proteins. Three major types of CRISPR–Cas system are delineated, with a further division into several subtypes and a few chimeric variants. Given the complexity of the genomic architectures and the extremely dynamic evolution of the CRISPR–Cas systems, a unified classification of these systems should be based on multiple criteria. Accordingly, we propose a `polythetic' classification that integrates the phylogenies of the most common cas genes, the sequence and organization of the CRISPR repeats and the architecture of the CRISPR–cas loci. PMID:21552286

  13. Glycan characterization of biopharmaceuticals: Updates and perspectives

    International Nuclear Information System (INIS)

    Planinc, Ana; Bones, Jonathan; Dejaegher, Bieke; Van Antwerpen, Pierre; Delporte, Cédric

    2016-01-01

    Therapeutic proteins are rapidly becoming the most promising class of pharmaceuticals on the market due to their successful treatment of a vast array of serious diseases, such as cancers and immune disorders. Therapeutic proteins are produced using recombinant DNA technology. More than 60% of therapeutic proteins are posttranslationally modified following biosynthesis by the addition of N- or O-linked glycans. Glycosylation is the most common posttranslational modifications of proteins. However, it is also the most demanding and complex posttranslational modification from the analytical point of view. Moreover, research has shown that glycosylation significantly impacts stability, half-life, mechanism of action and safety of a therapeutic protein. Considering the exponential growth of biotherapeutics, this present review of the literature (2009–2015) focuses on the characterization of protein glycosylation, which has witnessed an improvement in methodology. Furthermore, it discusses current issues in the fields of production and characterization of therapeutic proteins. This review also highlights the problem of non-standard requirements for the approval of biosimilars with regard to their glycosylation and discusses recent developments and perspectives for improved glycan characterization. - Highlights: • Biopharmaceuticals have emerged as the new class of blockbuster drugs in the pharmaceutical industry. • More than 60% of the approved biopharmaceuticals are glycosylated. • Glycosylation has an effect on the efficacy and the safety of therapeutic glycoproteins. • N-glycosylation characterization of therapeutic glycoproteins is a regulatory requirement. • Biosimilar releases are increasing and demonstration of comparability poses challenges for N-glycosylation characterization.

  14. Glycan characterization of biopharmaceuticals: Updates and perspectives

    Energy Technology Data Exchange (ETDEWEB)

    Planinc, Ana [Analytical Platform of the Faculty of Pharmacy and Laboratory of Pharmaceutical Chemistry, Faculty of Pharmacy, Universite Libre de Bruxelles (ULB), Brussels (Belgium); Bones, Jonathan [Characterisation and Comparability Laboratory, NIBRT – The National Institute for Bioprocessing Research and Training, Foster Avenue, Mount Merrion, Blackrock, Co. Dublin (Ireland); Dejaegher, Bieke [Laboratory of Instrumental Analysis and Bioelectrochemistry, Faculty of Pharmacy, Université Libre de Bruxelles (ULB), Boulevard du Triomphe, B-1050 Brussels (Belgium); Department of Analytical Chemistry and Pharmaceutical Technology (FABI), Center for Pharmaceutical Research (CePhaR), Faculty of Medicines and Pharmacy, Vrije Universiteit Brussel - VUB, Laarbeeklaan 103, B-1090 Brussels (Belgium); Van Antwerpen, Pierre [Analytical Platform of the Faculty of Pharmacy and Laboratory of Pharmaceutical Chemistry, Faculty of Pharmacy, Universite Libre de Bruxelles (ULB), Brussels (Belgium); Delporte, Cédric, E-mail: cedric.delporte@ulb.ac.be [Analytical Platform of the Faculty of Pharmacy and Laboratory of Pharmaceutical Chemistry, Faculty of Pharmacy, Universite Libre de Bruxelles (ULB), Brussels (Belgium)

    2016-05-19

    Therapeutic proteins are rapidly becoming the most promising class of pharmaceuticals on the market due to their successful treatment of a vast array of serious diseases, such as cancers and immune disorders. Therapeutic proteins are produced using recombinant DNA technology. More than 60% of therapeutic proteins are posttranslationally modified following biosynthesis by the addition of N- or O-linked glycans. Glycosylation is the most common posttranslational modifications of proteins. However, it is also the most demanding and complex posttranslational modification from the analytical point of view. Moreover, research has shown that glycosylation significantly impacts stability, half-life, mechanism of action and safety of a therapeutic protein. Considering the exponential growth of biotherapeutics, this present review of the literature (2009–2015) focuses on the characterization of protein glycosylation, which has witnessed an improvement in methodology. Furthermore, it discusses current issues in the fields of production and characterization of therapeutic proteins. This review also highlights the problem of non-standard requirements for the approval of biosimilars with regard to their glycosylation and discusses recent developments and perspectives for improved glycan characterization. - Highlights: • Biopharmaceuticals have emerged as the new class of blockbuster drugs in the pharmaceutical industry. • More than 60% of the approved biopharmaceuticals are glycosylated. • Glycosylation has an effect on the efficacy and the safety of therapeutic glycoproteins. • N-glycosylation characterization of therapeutic glycoproteins is a regulatory requirement. • Biosimilar releases are increasing and demonstration of comparability poses challenges for N-glycosylation characterization.

  15. Applications of Raman Spectroscopy in Biopharmaceutical Manufacturing: A Short Review.

    Science.gov (United States)

    Buckley, Kevin; Ryder, Alan G

    2017-06-01

    The production of active pharmaceutical ingredients (APIs) is currently undergoing its biggest transformation in a century. The changes are based on the rapid and dramatic introduction of protein- and macromolecule-based drugs (collectively known as biopharmaceuticals) and can be traced back to the huge investment in biomedical science (in particular in genomics and proteomics) that has been ongoing since the 1970s. Biopharmaceuticals (or biologics) are manufactured using biological-expression systems (such as mammalian, bacterial, insect cells, etc.) and have spawned a large (>€35 billion sales annually in Europe) and growing biopharmaceutical industry (BioPharma). The structural and chemical complexity of biologics, combined with the intricacy of cell-based manufacturing, imposes a huge analytical burden to correctly characterize and quantify both processes (upstream) and products (downstream). In small molecule manufacturing, advances in analytical and computational methods have been extensively exploited to generate process analytical technologies (PAT) that are now used for routine process control, leading to more efficient processes and safer medicines. In the analytical domain, biologic manufacturing is considerably behind and there is both a huge scope and need to produce relevant PAT tools with which to better control processes, and better characterize product macromolecules. Raman spectroscopy, a vibrational spectroscopy with a number of useful properties (nondestructive, non-contact, robustness) has significant potential advantages in BioPharma. Key among them are intrinsically high molecular specificity, the ability to measure in water, the requirement for minimal (or no) sample pre-treatment, the flexibility of sampling configurations, and suitability for automation. Here, we review and discuss a representative selection of the more important Raman applications in BioPharma (with particular emphasis on mammalian cell culture). The review shows that

  16. Quality assurance: The 10-Group Classification System (Robson classification), induction of labor, and cesarean delivery.

    LENUS (Irish Health Repository)

    Robson, Michael

    2015-10-01

    Quality assurance in labor and delivery is needed. The method must be simple and consistent, and be of universal value. It needs to be clinically relevant, robust, and prospective, and must incorporate epidemiological variables. The 10-Group Classification System (TGCS) is a simple method providing a common starting point for further detailed analysis within which all perinatal events and outcomes can be measured and compared. The system is demonstrated in the present paper using data for 2013 from the National Maternity Hospital in Dublin, Ireland. Interpretation of the classification can be easily taught. The standard table can provide much insight into the philosophy of care in the population of women studied and also provide information on data quality. With standardization of audit of events and outcomes, any differences in either sizes of groups, events or outcomes can be explained only by poor data collection, significant epidemiological variables, or differences in practice. In April 2015, WHO proposed that the TGCS (also known as the Robson classification) is used as a global standard for assessing, monitoring, and comparing cesarean delivery rates within and between healthcare facilities.

  17. CROHN'S DISEASE: GENERAL CHARACTERISTICS AND TREATMENT WITH ADALIMUMABE BIOPHARMACEUTICAL

    Directory of Open Access Journals (Sweden)

    S. A. Marques

    2018-02-01

    Full Text Available Crohn's Disease (CD is a chronic inflammatory disease that affects the gastrointestinal system. The etiology is not fully understood, however, genetic, immunological, microbiological and environmental factors are related to its genesis. The most common manifestations of this disease are diarrhea, abdominal pain, ulcers and fistulas. In the absence of adequate treatment it can evolve into extra intestinal complications and is also an important risk factor for colon and rectal cancer. The treatment of the disease is palliative and there is no cure for the disease, being considered only the period of remission of symptoms, as a good prognosis. The biopharmaceutical, Adalimumabe, produced by recombinant DNA technology has demonstrated efficacy in the treatment of this disease, as it prevents the action of TNF-α, a cytokine involved in inflammation and is abundant in individuals with CD. Although Adalimumabe has good results, its use leads to side effects that can be mild or fatal, such as the activation of tuberculosis.

  18. Carrot cells: a pioneering platform for biopharmaceuticals production.

    Science.gov (United States)

    Rosales-Mendoza, Sergio; Tello-Olea, Marlene Anahí

    2015-03-01

    Carrot (Daucus carota L.) is of importance in the molecular farming field as it constitutes the first plant species approved to produce biopharmaceuticals for human use. In this review, features that make carrot an advantageous species in the molecular farming field are analyzed and a description of the developments achieved with this crop thus far is presented. A guide for genetic transformation procedures is also included. The state of the art comprises ten vaccine prototypes against Measles virus, Hepatitis B virus, Human immunodeficiency virus, Yersinia pestis, Chlamydia trachomatis, Mycobacterium tuberculosis, enterotoxigenic Escherichia coli, Corynebacterium diphtheria/Clostridium tetani/Bordetella pertussis, and Helicobacter pylori; as well as the case of the glucocerebrosidase, an enzyme used for replacement therapy, and other therapeutics. Perspectives for these developments are envisioned and innovations are proposed such as the use of transplastomic technologies-, hairy roots-, and viral expression-based systems to improve yields and develop new products derived from this advantageous plant species.

  19. Hotel Classification Systems: A Comparison of International Case Studies

    Directory of Open Access Journals (Sweden)

    Roberta Minazzi,

    2010-12-01

    Full Text Available Over the last few decades we have witnessed an increasing interest of scholars andespecially operators in service quality in the lodging business. Firstly, it is important to observe thatthe diverseness of the hospitality industry also affects the classification of hotel quality. We canactually find many programmes, classifications and seals of quality promoted by public authoritiesand private companies that create confusion in the consumer perceptions of hotel quality. Moreover,new electronic distribution channels and their ratings are becoming a new way to gather informationabout a hotel and its quality. Secondly, a point that can cause complications is that different countriesand regions can choose differing approaches depending on the features of the classification (numberof levels, symbols used, etc. and the nature of the programme (public, private. Considering theseassumptions and the recent changes in the Italian hotel classification system, this paper aims toanalyse the situation in Italy, underlining both its positive and negative aspects and comparing it withother European and North American cases. Based on a review of literature and tourism laws as wellas personal interviews with public authorities and exponents of the private sectors, we were able toidentify critical issues and trends in hotel classification systems. The comparison of case studiesshows a heterogeneous situation. Points in common are the scale and the symbol used but, if weanalyse the requirements of each category, we discover very different circumstances, also sometimesin the same country. A future European classification system could be possible only after astandardization of minimum requirements and criteria at a national level. In this situation brands andonline consumers’ feedbacks become even more considered by the customers in the hospitalityindustry.

  20. Standard practice for classification of computed radiology systems

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2005-01-01

    1.1 This practice describes the evaluation and classification of a computed radiography (CR) system, a particular phosphor imaging plate (IP), system scanner and software, in combination with specified metal screens for industrial radiography. It is intended to ensure that the evaluation of image quality, as far as this is influenced by the scanner/IP system, meets the needs of users. 1.2 The practice defines system tests to be used to classify the systems of different suppliers and make them comparable for users. 1.3 The CR system performance is described by signal and noise parameters. For film systems, the signal is represented by gradient and the noise by granularity. The signal-to-noise ratio is normalized by the basic spatial resolution of the system and is part of classification. The normalization is given by the scanning aperture of 100 µm diameter for the micro-photometer, which is defined in Test Method E1815 for film system classification. This practice describes how the parameters shall be meas...

  1. Performance of classification confidence measures in dynamic classifier systems

    Czech Academy of Sciences Publication Activity Database

    Štefka, D.; Holeňa, Martin

    2013-01-01

    Roč. 23, č. 4 (2013), s. 299-319 ISSN 1210-0552 R&D Projects: GA ČR GA13-17187S Institutional support: RVO:67985807 Keywords : classifier combining * dynamic classifier systems * classification confidence Subject RIV: IN - Informatics, Computer Science Impact factor: 0.412, year: 2013

  2. Classification system for rain fed wheat grain cultivars using artificial ...

    African Journals Online (AJOL)

    Artificial neural network (ANN) models have found wide applications, including prediction, classification, system modeling and image processing. Image analysis based on texture, morphology and color features of grains is essential for various applications as wheat grain industry and cultivation. In order to classify the rain ...

  3. Developing a consensus classification system for acute renal failure

    NARCIS (Netherlands)

    Kellum, John A.; Levin, Nathan; Bouman, Catherine; Lameire, Norbert

    2002-01-01

    A biochemical definition and classification system for acute renal dysfunction is long overdue. Its absence has impeded progress in clinical and even basic research concerning a syndrome associated with mortality rates of 30 to 80%. No definition of acute renal dysfunction will be perfect, but the

  4. A Classification System for Recurrent Ameloblastoma of the Jaws ...

    African Journals Online (AJOL)

    A Classification System for Recurrent Ameloblastoma of the Jaws- Review of 30 Cases in Nigerians. GT Arotiba, AO Effiom, ASO Ayodele, MO Ogundana, MO Gbotolorun, HO Olasoji, O James, AL Ladeinde, VI Ugboko, KC Ndukwe, IC Ikem, RO Braimah ...

  5. Fundamental color classification systems for the digital imaging colorimetry

    Czech Academy of Sciences Publication Activity Database

    Pospíšil, Jaroslav; Hrdý, J.; Hrdý, jr., J.

    2006-01-01

    Roč. 51, č. 6 (2006), s. 175-178 ISSN 0447-6441 Institutional research plan: CEZ:AV0Z10100522 Keywords : color classification systems * color coordinates * analog and digital imaging colorimetry Subject RIV: BH - Optics, Masers, Lasers

  6. Classification system for rain fed wheat grain cultivars using artificial ...

    African Journals Online (AJOL)

    Jane

    2011-08-03

    Aug 3, 2011 ... Artificial neural network (ANN) models have found wide applications, including prediction, classification, system modeling and image processing. Image analysis based on texture, morphology and color features of grains is essential for various applications as wheat grain industry and cultivation. In order to ...

  7. Awareness and use of Gross Motor Function Classification System ...

    African Journals Online (AJOL)

    Introduction The degree of disability in children with Cerebral Palsy (CP) can be evaluated with the Gross Motor Function Classification System (GMFCS), a valid tool which was designed for such purposes. However, there appears to be paucity of data on the awareness and use of the GMFCS particularly in the ...

  8. An intelligent temporal pattern classification system using fuzzy ...

    Indian Academy of Sciences (India)

    In this paper, we propose a new pattern classification system by combining Temporal features with Fuzzy Min–Max (TFMM) neural network based classifier for effective decision support in medical diagnosis. Moreover, a Particle Swarm Optimization (PSO) algorithm based rule extractor is also proposed in this work for ...

  9. Towards a regional beef carcass classification system for Southern ...

    African Journals Online (AJOL)

    Mapiye, C, Dr

    2017-05-15

    May 15, 2017 ... abattoir, quality assurance schemes, including carcass grading and classification systems, are used to determine meat .... channel fat, and a liberal distribution of marbling at the point of quartering. .... promotants and beta-agonists, which affect meat tenderness negatively (Strydom et al., 2011; Frylinck et al.,.

  10. 42 CFR 412.513 - Patient classification system.

    Science.gov (United States)

    2010-10-01

    ... LTC-DRG classification system provides a LTC-DRG, and an appropriate weighting factor, for those cases....513 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES..., sex, principal diagnosis (that is, the diagnosis established after study to be chiefly responsible for...

  11. On a production system using default reasoning for pattern classification

    Science.gov (United States)

    Barry, Matthew R.; Lowe, Carlyle M.

    1990-01-01

    This paper addresses an unconventional application of a production system to a problem involving belief specialization. The production system reduces a large quantity of low-level descriptions into just a few higher-level descriptions that encompass the problem space in a more tractable fashion. This classification process utilizes a set of descriptions generated by combining the component hierarchy of a physical system with the semantics of the terminology employed in its operation. The paper describes an application of this process in a program, constructed in C and CLIPS, that classifies signatures of electromechanical system configurations. The program compares two independent classifications, describing the actual and expected system configurations, in order to generate a set of contradictions between the two.

  12. Computer-aided pattern classification system for dermoscopy images.

    Science.gov (United States)

    Abbas, Qaisar; Celebi, M Emre; Fondón, Irene

    2012-08-01

    Computer-aided pattern classification of melanoma and other pigmented skin lesions is one of the most important tasks for clinical diagnosis. To differentiate between benign and malignant lesions, the extraction of color, architectural order, symmetry of pattern and homogeneity (CASH) is a challenging task. In this article, a novel pattern classification system (PCS) based on the clinical CASH rule is presented to classify among six classes of patterns. The PCS system consists of the following five steps: transformation to the CIE L*a*b* color space, pre-processing to enhance the tumor region and removal of hairs, tumor-area segmentation, color and texture feature extraction, and finally, classification based on a multiclass support vector machine. The PCS system is tested on a total of 180 dermoscopic images. To test the performance of the PCS diagnostic classifier, the area under the receiver operating characteristics curve (AUC) is utilized. The proposed classifier achieved a sensitivity of 91.64%, specificity of 94.14%, and AUC of 0.948. The experimental results demonstrate that the proposed pattern classifier is highly accurate and classify between benign and malignant lesions into some extend. The PCS method is fully automatic and can accurately detect different patterns from dermoscopy images using color and texture properties. Additional pattern features can be included to investigate the impact of pattern classification based on the CASH rule. © 2011 John Wiley & Sons A/S.

  13. A Classification System for Hospital-Based Infection Outbreaks

    Directory of Open Access Journals (Sweden)

    Paul S. Ganney

    2010-01-01

    Full Text Available Outbreaks of infection within semi-closed environments such as hospitals, whether inherent in the environment (such as Clostridium difficile (C.Diff or Methicillinresistant Staphylococcus aureus (MRSA or imported from the wider community (such as Norwalk-like viruses (NLVs, are difficult to manage. As part of our work on modelling such outbreaks, we have developed a classification system to describe the impact of a particular outbreak upon an organization. This classification system may then be used in comparing appropriate computer models to real outbreaks, as well as in comparing different real outbreaks in, for example, the comparison of differing management and containment techniques and strategies. Data from NLV outbreaks in the Hull and East Yorkshire Hospitals NHS Trust (the Trust over several previous years are analysed and classified, both for infection within staff (where the end of infection date may not be known and within patients (where it generally is known. A classification system consisting of seven elements is described, along with a goodness-of-fit method for comparing a new classification to previously known ones, for use in evaluating a simulation against history and thereby determining how ‘realistic’ (or otherwise it is.

  14. A classification system for hospital-based infection outbreaks.

    Science.gov (United States)

    Ganney, Paul S; Madeo, Maurice; Phillips, Roger

    2010-12-01

    Outbreaks of infection within semi-closed environments such as hospitals, whether inherent in the environment (such as Clostridium difficile (C.Diff) or Methicillin-resistant Staphylococcus aureus (MRSA) or imported from the wider community (such as Norwalk-like viruses (NLVs)), are difficult to manage. As part of our work on modelling such outbreaks, we have developed a classification system to describe the impact of a particular outbreak upon an organization. This classification system may then be used in comparing appropriate computer models to real outbreaks, as well as in comparing different real outbreaks in, for example, the comparison of differing management and containment techniques and strategies. Data from NLV outbreaks in the Hull and East Yorkshire Hospitals NHS Trust (the Trust) over several previous years are analysed and classified, both for infection within staff (where the end of infection date may not be known) and within patients (where it generally is known). A classification system consisting of seven elements is described, along with a goodness-of-fit method for comparing a new classification to previously known ones, for use in evaluating a simulation against history and thereby determining how 'realistic' (or otherwise) it is.

  15. Classification

    Science.gov (United States)

    Oza, Nikunj C.

    2011-01-01

    A supervised learning task involves constructing a mapping from input data (normally described by several features) to the appropriate outputs. Within supervised learning, one type of task is a classification learning task, in which each output is one or more classes to which the input belongs. In supervised learning, a set of training examples---examples with known output values---is used by a learning algorithm to generate a model. This model is intended to approximate the mapping between the inputs and outputs. This model can be used to generate predicted outputs for inputs that have not been seen before. For example, we may have data consisting of observations of sunspots. In a classification learning task, our goal may be to learn to classify sunspots into one of several types. Each example may correspond to one candidate sunspot with various measurements or just an image. A learning algorithm would use the supplied examples to generate a model that approximates the mapping between each supplied set of measurements and the type of sunspot. This model can then be used to classify previously unseen sunspots based on the candidate's measurements. This chapter discusses methods to perform machine learning, with examples involving astronomy.

  16. CLASSIFICATION OF THE MGR SITE GENERATED RADIOLOGICAL WASTE HANDLING SYSTEM

    International Nuclear Information System (INIS)

    S.E. Salzman

    1999-01-01

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) site-generated radiological waste handling system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333P, ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998)

  17. CLASSIFICATION OF THE MGR SURFACE ENVIRONMENTAL MONITORING SYSTEM

    International Nuclear Information System (INIS)

    J.A. Ziegler

    1999-01-01

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) surface environmental monitoring system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333PY ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998)

  18. Annotation and Classification of CRISPR-Cas Systems.

    Science.gov (United States)

    Makarova, Kira S; Koonin, Eugene V

    2015-01-01

    The clustered regularly interspaced short palindromic repeats (CRISPR)-Cas (CRISPR-associated proteins) is a prokaryotic adaptive immune system that is represented in most archaea and many bacteria. Among the currently known prokaryotic defense systems, the CRISPR-Cas genomic loci show unprecedented complexity and diversity. Classification of CRISPR-Cas variants that would capture their evolutionary relationships to the maximum possible extent is essential for comparative genomic and functional characterization of this theoretically and practically important system of adaptive immunity. To this end, a multipronged approach has been developed that combines phylogenetic analysis of the conserved Cas proteins with comparison of gene repertoires and arrangements in CRISPR-Cas loci. This approach led to the current classification of CRISPR-Cas systems into three distinct types and ten subtypes for each of which signature genes have been identified. Comparative genomic analysis of the CRISPR-Cas systems in new archaeal and bacterial genomes performed over the 3 years elapsed since the development of this classification makes it clear that new types and subtypes of CRISPR-Cas need to be introduced. Moreover, this classification system captures only part of the complexity of CRISPR-Cas organization and evolution, due to the intrinsic modularity and evolutionary mobility of these immunity systems, resulting in numerous recombinant variants. Moreover, most of the cas genes evolve rapidly, complicating the family assignment for many Cas proteins and the use of family profiles for the recognition of CRISPR-Cas subtype signatures. Further progress in the comparative analysis of CRISPR-Cas systems requires integration of the most sensitive sequence comparison tools, protein structure comparison, and refined approaches for comparison of gene neighborhoods.

  19. A Chinese text classification system based on Naive Bayes algorithm

    Directory of Open Access Journals (Sweden)

    Cui Wei

    2016-01-01

    Full Text Available In this paper, aiming at the characteristics of Chinese text classification, using the ICTCLAS(Chinese lexical analysis system of Chinese academy of sciences for document segmentation, and for data cleaning and filtering the Stop words, using the information gain and document frequency feature selection algorithm to document feature selection. Based on this, based on the Naive Bayesian algorithm implemented text classifier , and use Chinese corpus of Fudan University has carried on the experiment and analysis on the system.

  20. CLASSIFICATION OF THE MGR WASTE TREATMENT BUILDING VENTILATION SYSTEM

    International Nuclear Information System (INIS)

    S.E. Salzman

    1999-01-01

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) waste treatment building ventilation system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333P, ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998)

  1. Annotation and Classification of CRISPR-Cas Systems

    Science.gov (United States)

    Makarova, Kira S.; Koonin, Eugene V.

    2018-01-01

    The clustered regularly interspaced short palindromic repeats (CRISPR)-Cas (CRISPR-associated proteins) is a prokaryotic adaptive immune system that is represented in most archaea and many bacteria. Among the currently known prokaryotic defense systems, the CRISPR-Cas genomic loci show unprecedented complexity and diversity. Classification of CRISPR-Cas variants that would capture their evolutionary relationships to the maximum possible extent is essential for comparative genomic and functional characterization of this theoretically and practically important system of adaptive immunity. To this end, a multipronged approach has been developed that combines phylogenetic analysis of the conserved Cas proteins with comparison of gene repertoires and arrangements in CRISPR-Cas loci. This approach led to the current classification of CRISPR-Cas systems into three distinct types and ten subtypes for each of which signature genes have been identified. Comparative genomic analysis of the CRISPR-Cas systems in new archaeal and bacterial genomes performed over the 3 years elapsed since the development of this classification makes it clear that new types and subtypes of CRISPR-Cas need to be introduced. Moreover, this classification system captures only part of the complexity of CRISPR-Cas organization and evolution, due to the intrinsic modularity and evolutionary mobility of these immunity systems, resulting in numerous recombinant variants. Moreover, most of the cas genes evolve rapidly, complicating the family assignment for many Cas proteins and the use of family profiles for the recognition of CRISPR-Cas subtype signatures. Further progress in the comparative analysis of CRISPR-Cas systems requires integration of the most sensitive sequence comparison tools, protein structure comparison, and refined approaches for comparison of gene neighborhoods. PMID:25981466

  2. A classification system for pressure vessel shell failures

    International Nuclear Information System (INIS)

    Harrop, L.P.

    1989-01-01

    A system for classifying failures of the shells of pressure vessels is presented. The classification system is based on the way a failure physically manifests itself and not on imputed economic or safety significance. It is believed the described way of classifying the failures is useful for transferring information from one situation to another. In assigning names to types of failure, the intention has been to adopt explicit definitions rather than supposed colloquial usage. (author)

  3. CLASSIFICATION OF THE MGR SITE COMPRESSED AIR SYSTEM

    International Nuclear Information System (INIS)

    J.A. Ziegler

    1999-01-01

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) site compressed air system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333P, ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998)

  4. Classification of Recommender Expertise in the Wikipedia Recommender System

    DEFF Research Database (Denmark)

    Jensen, Christian D.; Pilkauskas, Povilas; Lefévre, Thomas

    2011-01-01

    to the quality of articles. The Wikipedia Recommender System (WRS) was developed to help users determine the credibility of articles based on feedback from other Wikipedia users. The WRS implements a collaborative filtering system with trust metrics, i.e., it provides a rating of articles which emphasizes...... an evaluation of four existing knowledge classification schemes with respect to these requirements. This evaluation helped us identify a classification scheme, which we have implemented in the current version of the Wikipedia Recommender System....... feedback from recommenders that the user has agreed with in the past. This exposes the problem that most recommenders are not equally competent in all subject areas. The first WRS prototype did not include an evaluation of the areas of expertise of recommenders, so the trust metric used in the article...

  5. Classification of Recommender Expertise in the Wikipedia Recommender System

    DEFF Research Database (Denmark)

    Jensen, Christian D.; Pilkauskas, Povilas; Lefevre, Thomas

    2011-01-01

    to the quality of articles. The Wikipedia Recommender System (WRS) was developed to help users determine the credibility of articles based on feedback from other Wikipedia users. The WRS implements a collaborative filtering system with trust metrics, i.e., it provides a rating of articles "which emphasizes...... an evaluation of four existing knowledge classification schemes with respect to these requirements. This evaluation helped us identify a classification scheme, which we have implemented in the current version of the Wikipedia Recommender System....... feedback from recommenders that the user has agreed with in the past. This exposes the problem that most recommenders are not equally competent in all subject areas. The first WRS prototype did not include an evaluation of the areas of expertise of recommenders, so the trust metric used in the article...

  6. Improvement of the Radiological system of emergency classification in Cuba

    International Nuclear Information System (INIS)

    Jerez Vegueria, Pablo F.; Yamil Lopez Forteza; Diaz Guerra, Pedro I.

    2003-01-01

    In 1998 the National Center of Nuclear Security (CNSN), on the base of the experience in the one handling of emergencies and the preparation aspects, planning and answer, it perfects and it modernizes, with the approval of the national bigger State of the Civil Defense, the approaches of the Scale of Radiological Events approved from 1992. Given the operational experience of the System of Answer to Emergency of the Ministry Of Science Technology And Environment in the year 2001 the CNSN develops, it perfects and it puts in vigor a more complete System of Classification of Emergency of unique use for all the entities that use sources of radiations ionizations and that it also includes those answer forces that are imbricate in the Plan of Measures Against Catastrophe for cases of Radiological Accidents. The setting in vigor of this Unique System of Classification of Emergencies at national level has allowed to secure the coordination, planning and answer in an effective, quick and effective way. Presently work is exposed the philosophy on which this System of Classification was elaborated, the approaches used to classify the events as much in radioactive facilities as in the practice of the transport of radioactive materials and the activation of the forces of answers in cases of radiological emergencies

  7. Validation of a new classification system for skin tears.

    Science.gov (United States)

    LeBlanc, Kimberly; Baranoski, Sharon; Holloway, Samantha; Langemo, Diane

    2013-06-01

    The aim of this study was to validate and establish reliability of the International Skin Tear classification system. A consensus panel of 12 internationally recognized key opinion leaders convened in 2011 to establish consensus statements on the prevention, prediction, assessment, and treatment of skin tears. Subsequently, a new skin tear classification system was proposed. The system was then tested for interrater and intrarater reliability between the experts before being tested more widely on a sample of 327 individuals from the United States, Canada, and Europe. The results of the study indicated a substantial level of agreement for the expert panel (Fleiss κ = 0.619; 2-month follow-up = 0.653). Intrarater reliability was high (Cohen κ = 0.877). Interrater reliability was moderate (Fleiss κ = 0.555) for healthcare professionals (n = 303) and fair for non-health professionals (Fleiss κ = 0.338; n = 24). This international study established the reliability and validity of a new classification system for skin tears.

  8. The stability of the Manual Ability Classification System over time.

    Science.gov (United States)

    Öhrvall, Ann-Marie; Krumlinde-Sundholm, Lena; Eliasson, Ann-Christin

    2014-02-01

    To evaluate the stability over time of the Manual Ability Classification System (MACS) levels. The study group comprised 1267 children with cerebral palsy (746 males, 521 females) who were followed from 2005 to 2010 with two or more registered MACS classifications rated at least 1 year apart. Thirty-five percent of the children (n=445) had four MACS registrations. The children were between 4 and 17 years old at their first rating, The stability over time was also compared between children who were younger (4y of age) or older (≥10y) at the time of their first classification. An excellent stability was found between two ratings at 1-year intervals with an intraclass correlation coefficient (ICC) of 0.97 (95% CI 0.97-0.97) and 82% agreement (n=1267). The stability was also excellent for two ratings performed 3 to 5 years apart (ICC 0.96; 95% CI 0.95-0.97) with an agreement of 78% (n=445). Across four ratings, 70% of the children remained at the same level. The results were similar for younger and older children, indicating that stability was not influenced by age. This study provides evidence that MACS levels are stable over time and that the classification has predictive value. © 2013 Mac Keith Press.

  9. Classification of Recommender Expertise in the Wikipedia Recommender System

    DEFF Research Database (Denmark)

    Jensen, Christian D.; Pilkauskas, Povilas; Lefevre, Thomas

    2011-01-01

    The Wikipedia is a web-based encyclopedia, written and edited collaboratively by Internet users. The Wikipedia has an extremely open editorial policy that allows anybody, to create or modify articles. This has promoted a broad and detailed coverage of subjects, but also introduced problems relating...... to the quality of articles. The Wikipedia Recommender System (WRS) was developed to help users determine the credibility of articles based on feedback from other Wikipedia users. The WRS implements a collaborative filtering system with trust metrics, i.e., it provides a rating of articles "which emphasizes...... in the Wikipedia. In this paper, we examine different ways to classify the subject area of Wikipedia article according to well established knowledge classification schemes. We identify a number of requirements that a classification scheme must meet in order to be useful in the context of the WRS and present...

  10. Side effects of cancer therapies. International classification and documentation systems

    International Nuclear Information System (INIS)

    Seegenschmiedt, M.H.

    1998-01-01

    The publication presents and explains verified, international classification and documentation systems for side effects induced by cancer treatments, applicable in general and clinical practice and clinical research, and covers in a clearly arranged manner the whole range of treatments, including acute and chronic side effects of chemotherapy and radiotherapy, surgery, or combined therapies. The book fills a long-felt need in tumor documentation and is a major contribution to quality assurance in clinical oncology in German-speaking countries. As most parts of the book are bilingual, presenting German and English texts and terminology, it satisfies the principles of interdisciplinarity and internationality. The tabulated form chosen for presentation of classification systems and criteria facilitate the user's approach as well as application in daily work. (orig./CB) [de

  11. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus

    DEFF Research Database (Denmark)

    Petri, Michelle; Orbai, Ana-Maria; Alarcón, Graciela S

    2012-01-01

    The Systemic Lupus International Collaborating Clinics (SLICC) group revised and validated the American College of Rheumatology (ACR) systemic lupus erythematosus (SLE) classification criteria in order to improve clinical relevance, meet stringent methodology requirements, and incorporate new...

  12. Classification of Transient Phenomena in Distribution System using wavelet Transform

    Science.gov (United States)

    Sedighi, Alireza

    2014-05-01

    An efficient procedure for classification of transient phenomena in distribution systems is proposed in this paper. The proposed method has been applied to classify some transient phenomena such as inrush current, load switching, capacitor switching and single phase to ground fault. The new scheme is based on wavelet transform algorithm. All of the events for feature extraction and test are simulated using Electro Magnetic Transient Program (EMTP). Results show high accuracy of proposed method.

  13. London 2012 Paralympic swimming: passive drag and the classification system.

    Science.gov (United States)

    Oh, Yim-Taek; Burkett, Brendan; Osborough, Conor; Formosa, Danielle; Payton, Carl

    2013-09-01

    The key difference between the Olympic and Paralympic Games is the use of classification systems within Paralympic sports to provide a fair competition for athletes with a range of physical disabilities. In 2009, the International Paralympic Committee mandated the development of new, evidence-based classification systems. This study aims to assess objectively the swimming classification system by determining the relationship between passive drag and level of swimming-specific impairment, as defined by the current swimming class. Data were collected on participants at the London 2012 Paralympic Games. The passive drag force of 113 swimmers (classes 3-14) was measured using an electro-mechanical towing device and load cell. Swimmers were towed on the surface of a swimming pool at 1.5 m/s while holding their most streamlined position. Passive drag ranged from 24.9 to 82.8 N; the normalised drag (drag/mass) ranged from 0.45 to 1.86 N/kg. Significant negative associations were found between drag and the swimming class (τ = -0.41, p < 0.01) and normalised drag and the swimming class (τ = -0.60, p < 0.01). The mean difference in drag between adjacent classes was inconsistent, ranging from 0 N (6 vs 7) to 11.9 N (5 vs 6). Reciprocal Ponderal Index (a measure of slenderness) correlated moderately with normalised drag (r(P) = -0.40, p < 0.01). Although swimmers with the lowest swimming class experienced the highest passive drag and vice versa, the inconsistent difference in mean passive drag between adjacent classes indicates that the current classification system does not always differentiate clearly between swimming groups.

  14. Capillary electrophoresis in the N-glycosylation analysis of biopharmaceuticals

    Czech Academy of Sciences Publication Activity Database

    Guttman, András

    2013-01-01

    Roč. 48, JUL-AUG (2013), s. 132-143 ISSN 0165-9936 Institutional support: RVO:68081715 Keywords : automated workflow * biopharmaceuticals * capillary electrophoresis Subject RIV: CB - Analytical Chemistry, Separation Impact factor: 6.612, year: 2013

  15. Locust bean gum: Exploring its potential for biopharmaceutical applications

    Directory of Open Access Journals (Sweden)

    Marita Dionísio

    2012-01-01

    Full Text Available Polysaccharides have been finding, in the last decades, very interesting and useful applications in the biomedical and, specifically, in the biopharmaceutical field. Locust bean gum is a polysaccharide belonging to the group of galactomannans, being extracted from the seeds of the carob tree (Ceratonia siliqua. This polymer displays a number of appealing characteristics for biopharmaceutical applications, among which its high gelling capacity should be highlighted. In this review, we describe critical aspects of locust bean gum, contributing for its role in biopharmaceutical applications. Physicochemical properties, as well as strong and effective synergies with other biomaterials are described. The potential for in vivo biodegradation is explored and the specific biopharmaceutical applications are discussed.

  16. A survey and classification of telecommunication needs in power systems

    Energy Technology Data Exchange (ETDEWEB)

    Adeyemo, A.A.; Jimoh, A.A.; Munda, J.L.; Oyedapo, O.J. [Tshwane Univ. of Technology, Pretoria (South Africa). Dept. of Electrical Engineering

    2008-07-01

    This paper discussed telecommunications needs for electric power systems. Needs were classified based on their sensitivity to delay, bit errors, and variations of delay. The aim of the study was to assess the usefulness of new telecommunications technologies. Communication needs in the power industry included security; power system control; asset management; fault detection; metering; and telephony. The use of telecommunications technologies with SCADA system hardware and controllers was discussed. The success of teleprotection systems for preventing short circuits was also discussed. Real time operational communication requirements were studied in addition to administrative operational communication requirements. Voice, data, and video telecommunications systems were compared and evaluated. Metering system components were reviewed. The classification system can be used to accurately assess power systems telecommunications requirements. 10 refs., 1 tab., 2 figs.

  17. CLASSIFICATION OF THE MGR CARRIER PREPARATION BUILDING MATERIALS HANDLING SYSTEM

    International Nuclear Information System (INIS)

    J.A. Ziegler

    2001-01-01

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) carrier preparation building materials handling system structures, systems and components (SSCs) performed by the MGR Preclosure Safety and Systems Engineering Section. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 2000). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333P7 ''Quality Assurance Requirements and Description'' (QARD) (DOE 2000)

  18. Classification of cognitive systems dedicated to data sharing

    Science.gov (United States)

    Ogiela, Lidia; Ogiela, Marek R.

    2017-08-01

    In this paper will be presented classification of new cognitive information systems dedicated to cryptographic data splitting and sharing processes. Cognitive processes of semantic data analysis and interpretation, will be used to describe new classes of intelligent information and vision systems. In addition, cryptographic data splitting algorithms and cryptographic threshold schemes will be used to improve processes of secure and efficient information management with application of such cognitive systems. The utility of the proposed cognitive sharing procedures and distributed data sharing algorithms will be also presented. A few possible application of cognitive approaches for visual information management and encryption will be also described.

  19. Automated recognition system for ELM classification in JET

    International Nuclear Information System (INIS)

    Duro, N.; Dormido, R.; Vega, J.; Dormido-Canto, S.; Farias, G.; Sanchez, J.; Vargas, H.; Murari, A.

    2009-01-01

    Edge localized modes (ELMs) are instabilities occurring in the edge of H-mode plasmas. Considerable efforts are being devoted to understanding the physics behind this non-linear phenomenon. A first characterization of ELMs is usually their identification as type I or type III. An automated pattern recognition system has been developed in JET for off-line ELM recognition and classification. The empirical method presented in this paper analyzes each individual ELM instead of starting from a temporal segment containing many ELM bursts. The ELM recognition and isolation is carried out using three signals: Dα, line integrated electron density and stored diamagnetic energy. A reduced set of characteristics (such as diamagnetic energy drop, ELM period or Dα shape) has been extracted to build supervised and unsupervised learning systems for classification purposes. The former are based on support vector machines (SVM). The latter have been developed with hierarchical and K-means clustering methods. The success rate of the classification systems is about 98% for a database of almost 300 ELMs.

  20. A Biochar Classification System and Associated Test Methods

    Energy Technology Data Exchange (ETDEWEB)

    Camps-Arbestain, Marta; Amonette, James E.; Singh, Balwant; Wang, Tao; Schmidt, Hans-Peter

    2015-02-18

    In this chapter, a biochar classification system related to its use as soil amendment is proposed. This document builds upon previous work and constrains its scope to materials with properties that satisfy the criteria for biochar as defined by either the International Biochar Initiative (IBI) Biochar Standards or the European Biochar Community (EBC) Standards, and it is intended to minimise the need for testing in addition to those required according to the above-mentioned standards. The classification system envisions enabling stakeholders and commercial entities to (i) identify the most suitable biochar to fulfil the requirements for a particular soil and/or land-use, and (ii) distinguish the application of biochar for specific niches (e.g., soilless agriculture). It is based on the best current knowledge and the intention is to periodically review and update the document based on new data and knowledge that become available in the scientific literature. The main thrust of this classification system is based on the direct or indirect beneficial effects that biochar provides from its application to soil. We have classified the potential beneficial effects of biochar application to soils into five categories with their corresponding classes, where applicable: (i) carbon (C) storage value, (ii) fertiliser value, (iii) liming value, (iv) particle-size, and (v) use in soil-less agriculture. A summary of recommended test methods is provided at the end of the chapter.

  1. Automated recognition system for ELM classification in JET

    Energy Technology Data Exchange (ETDEWEB)

    Duro, N. [Dpto. de Informatica y Automatica - UNED, C/ Juan del Rosal 16, 28040 Madrid (Spain)], E-mail: nduro@dia.uned.es; Dormido, R. [Dpto. de Informatica y Automatica - UNED, C/ Juan del Rosal 16, 28040 Madrid (Spain); Vega, J. [Asociacion EURATOM/CIEMAT para Fusion, Avd. Complutense 22, 28040 Madrid (Spain); Dormido-Canto, S.; Farias, G.; Sanchez, J.; Vargas, H. [Dpto. de Informatica y Automatica - UNED, C/ Juan del Rosal 16, 28040 Madrid (Spain); Murari, A. [Consorzio RFX-Associazione EURATOM ENEA per la Fusione, I-35127 Padua (Italy)

    2009-06-15

    Edge localized modes (ELMs) are instabilities occurring in the edge of H-mode plasmas. Considerable efforts are being devoted to understanding the physics behind this non-linear phenomenon. A first characterization of ELMs is usually their identification as type I or type III. An automated pattern recognition system has been developed in JET for off-line ELM recognition and classification. The empirical method presented in this paper analyzes each individual ELM instead of starting from a temporal segment containing many ELM bursts. The ELM recognition and isolation is carried out using three signals: D{alpha}, line integrated electron density and stored diamagnetic energy. A reduced set of characteristics (such as diamagnetic energy drop, ELM period or D{alpha} shape) has been extracted to build supervised and unsupervised learning systems for classification purposes. The former are based on support vector machines (SVM). The latter have been developed with hierarchical and K-means clustering methods. The success rate of the classification systems is about 98% for a database of almost 300 ELMs.

  2. Biopharmaceutical Process Optimization with Simulation and Scheduling Tools

    OpenAIRE

    Petrides, Demetri; Carmichael, Doug; Siletti, Charles; Koulouris, Alexandros

    2014-01-01

    Design and assessment activities associated with a biopharmaceutical process are performed at different levels of detail, based on the stage of development that the product is in. Preliminary “back-of-the envelope” assessments are performed early in the development lifecycle, whereas detailed design and evaluation are performed prior to the construction of a new facility. Both the preliminary and detailed design of integrated biopharmaceutical processes can be greatly assisted by the use of p...

  3. A Novel Classification System for Injuries After Electronic Cigarette Explosions.

    Science.gov (United States)

    Patterson, Scott B; Beckett, Allison R; Lintner, Alicia; Leahey, Carly; Greer, Ashley; Brevard, Sidney B; Simmons, Jon D; Kahn, Steven A

    Electronic cigarettes (e-cigarettes) contain lithium batteries that have been known to explode and/or cause fires that have resulted in burn injury. The purpose of this article is to present a case study, review injuries caused by e-cigarettes, and present a novel classification system from the newly emerging patterns of burns. A case study was presented and online media reports for e-cigarette burns were queried with search terms "e-cigarette burns" and "electronic cigarette burns." The reports and injury patterns were tabulated. Analysis was then performed to create a novel classification system based on the distinct injury patterns seen in the study. Two patients were seen at our regional burn center after e-cigarette burns. One had an injury to his thigh and penis that required operative intervention after ignition of this device in his pocket. The second had a facial burn and corneal abrasions when the device exploded while he was inhaling vapor. The Internet search and case studies resulted in 26 cases for evaluation. The burn patterns were divided in direct injury from the device igniting and indirect injury when the device caused a house or car fire. A numerical classification was created: direct injury: type 1 (hand injury) 7 cases, type 2 (face injury) 8 cases, type 3 (waist/groin injury) 11 cases, and type 5a (inhalation injury from using device) 2 cases; indirect injury: type 4 (house fire injury) 7 cases and type 5b (inhalation injury from fire started by the device) 4 cases. Multiple e-cigarette injuries are occurring in the United States and distinct patterns of burns are emerging. The classification system developed in this article will aid in further study and future regulation of these dangerous devices.

  4. PEGylated Biopharmaceuticals: Current Experience and Considerations for Nonclinical Development.

    Science.gov (United States)

    Ivens, Inge A; Achanzar, William; Baumann, Andreas; Brändli-Baiocco, Annamaria; Cavagnaro, Joy; Dempster, Maggie; Depelchin, B Olympe; Rovira, Armando R Irizarry; Dill-Morton, Laura; Lane, Joan H; Reipert, Birgit M; Salcedo, Theodora; Schweighardt, Becky; Tsuruda, Laurie S; Turecek, Peter L; Sims, Jennifer

    2015-10-01

    PEGylation (the covalent binding of one or more polyethylene glycol molecules to another molecule) is a technology frequently used to improve the half-life and other pharmaceutical or pharmacological properties of proteins, peptides, and aptamers. To date, 11 PEGylated biopharmaceuticals have been approved and there is indication that many more are in nonclinical or clinical development. Adverse effects seen with those in toxicology studies are mostly related to the active part of the drug molecule and not to polyethylene glycol (PEG). In 5 of the 11 approved and 10 of the 17 PEGylated biopharmaceuticals in a 2013 industry survey presented here, cellular vacuolation is histologically observed in toxicology studies in certain organs and tissues. No other effects attributed to PEG alone have been reported. Importantly, vacuolation, which occurs mainly in phagocytes, has not been linked with changes in organ function in these toxicology studies. This article was authored through collaborative efforts of industry toxicologists/nonclinical scientists to address the nonclinical safety of large PEG molecules (>10 kilo Dalton) in PEGylated biopharmaceuticals. The impact of the PEG molecule on overall nonclinical safety assessments of PEGylated biopharmaceuticals is discussed, and toxicological information from a 2013 industry survey on PEGylated biopharmaceuticals under development is summarized. Results will contribute to the database of toxicological information publicly available for PEG and PEGylated biopharmaceuticals. © 2015 by The Author(s).

  5. Antibodies Against Complement Components: Relevance for the Antiphospholipid Syndrome-Biomarkers of the Disease and Biopharmaceuticals.

    Science.gov (United States)

    Bećarević, Mirjana

    2017-07-01

    Laboratory criterion for the diagnosis of antiphospholipid syndrome (APS) is the presence of antiphospholipid antibodies (aPL Abs). Complement system has a role in mediating aPL Abs-induced thrombosis in animal models. The importance of antibodies against complement components (potential biomarkers of APS) and the importance of antibodies with beneficial anti-complement effects in APS (as biopharmaceuticals) are reviewed. Antibodies against complement components described in APS patients, so far, are anti-C1q and anti-factor H Abs, although anti-factor B Abs and anti-C5a Abs were described in animal models of APS. Clinical studies in APS patients are limited to a small number of case reports. Studies that would confirm potential role of Abs against complement components (as potential biomarkers of APS) are lacking. Lack of randomized clinical trials (that would provide complete data for confirmation of beneficial effects of biopharmaceuticals in complement inhibition) in APS is alarming.

  6. Classification of Unmanned Aircraft Systems. UAS Classification/Categorization for Certification

    Science.gov (United States)

    2004-01-01

    Category, class, and type designations are primary means to identify appropriate aircraft certification basis, operating rules/limitations, and pilot qualifications to operate in the National Airspace System (NAS). The question is whether UAS fit into existing aircraft categories or classes, or are unique enough to justify the creation of a new category/class. In addition, the characteristics or capabilities, which define when an UAS becomes a regulated aircraft, must also be decided. This issue focuses on UAS classification for certification purposes. Several approaches have been considered for classifying UAS. They basically group into either using a weight/mass basis, or a safety risk basis, factoring in the performance of the UAS, including where the UAS would operate. Under existing standards, aircraft must have a Type Certificate and Certificate of Airworthiness, in order to be used for "compensation or hire", a major difference from model aircraft. Newer technologies may make it possible for very small UAS to conduct commercial services, but that is left for a future discussion to extend the regulated aircraft to a lower level. The Access 5 position is that UAS are aircraft and should be regulated above the weight threshold differentiating them from model airplanes. The recommended classification grouping is summarized in a chart.

  7. The Comprehensive AOCMF Classification System: Midface Fractures - Level 3 Tutorial

    Science.gov (United States)

    Cornelius, Carl-Peter; Audigé, Laurent; Kunz, Christoph; Buitrago-Téllez, Carlos H.; Rudderman, Randal; Prein, Joachim

    2014-01-01

    This tutorial outlines the details of the AOCMF image-based classification system for fractures of the midface at the precision level 3. The topography of the different midface regions (central midface—upper central midface, intermediate central midface, lower central midface—incorporating the naso-orbito-ethmoid region; lateral midface—zygoma and zygomatic arch, palate) is subdivided in much greater detail than in level 2 going beyond the Le Fort fracture types and its analogs. The level 3 midface classification system is presented along with guidelines to precisely delineate the fracture patterns in these specific subregions. It is easy to plot common fracture entities, such as nasal and naso-orbito-ethmoid, and their variants due to the refined structural layout of the subregions. As a key attribute, this focused approach permits to document the occurrence of fragmentation (i.e., single vs. multiple fracture lines), displacement, and bone loss. Moreover, the preinjury dental state and the degree of alveolar atrophy in edentulous maxillary regions can be recorded. On the basis of these individual features, tooth injuries, periodontal trauma, and fracture involvement of the alveolar process can be assessed. Coding rules are given to set up a distinctive formula for typical midface fractures and their combinations. The instructions and illustrations are elucidated by a series of radiographic imaging examples. A critical appraisal of the design of this level 3 midface classification is made. PMID:25489392

  8. An alternative respiratory sounds classification system utilizing artificial neural networks

    Directory of Open Access Journals (Sweden)

    Rami J Oweis

    2015-04-01

    Full Text Available Background: Computerized lung sound analysis involves recording lung sound via an electronic device, followed by computer analysis and classification based on specific signal characteristics as non-linearity and nonstationarity caused by air turbulence. An automatic analysis is necessary to avoid dependence on expert skills. Methods: This work revolves around exploiting autocorrelation in the feature extraction stage. All process stages were implemented in MATLAB. The classification process was performed comparatively using both artificial neural networks (ANNs and adaptive neuro-fuzzy inference systems (ANFIS toolboxes. The methods have been applied to 10 different respiratory sounds for classification. Results: The ANN was superior to the ANFIS system and returned superior performance parameters. Its accuracy, specificity, and sensitivity were 98.6%, 100%, and 97.8%, respectively. The obtained parameters showed superiority to many recent approaches. Conclusions: The promising proposed method is an efficient fast tool for the intended purpose as manifested in the performance parameters, specifically, accuracy, specificity, and sensitivity. Furthermore, it may be added that utilizing the autocorrelation function in the feature extraction in such applications results in enhanced performance and avoids undesired computation complexities compared to other techniques.

  9. An alternative respiratory sounds classification system utilizing artificial neural networks.

    Science.gov (United States)

    Oweis, Rami J; Abdulhay, Enas W; Khayal, Amer; Awad, Areen

    2015-01-01

    Computerized lung sound analysis involves recording lung sound via an electronic device, followed by computer analysis and classification based on specific signal characteristics as non-linearity and nonstationarity caused by air turbulence. An automatic analysis is necessary to avoid dependence on expert skills. This work revolves around exploiting autocorrelation in the feature extraction stage. All process stages were implemented in MATLAB. The classification process was performed comparatively using both artificial neural networks (ANNs) and adaptive neuro-fuzzy inference systems (ANFIS) toolboxes. The methods have been applied to 10 different respiratory sounds for classification. The ANN was superior to the ANFIS system and returned superior performance parameters. Its accuracy, specificity, and sensitivity were 98.6%, 100%, and 97.8%, respectively. The obtained parameters showed superiority to many recent approaches. The promising proposed method is an efficient fast tool for the intended purpose as manifested in the performance parameters, specifically, accuracy, specificity, and sensitivity. Furthermore, it may be added that utilizing the autocorrelation function in the feature extraction in such applications results in enhanced performance and avoids undesired computation complexities compared to other techniques.

  10. Thyroid fine-needle aspiration and the bethesda classification system

    DEFF Research Database (Denmark)

    Larsen, Louise Vølund; Egset, Alice Viktoria; Holm, Camilla

    2018-01-01

    INTRODUCTION: Fine-needle aspiration (FNA) is a cornerstone in diagnosing thyroid nodules. For decades, Danish FNA have been categorised into the groups: “FNA not per-formed”, “Inadequate”, “Cystic”, “Inconclusive”, “Benign”, “Suspicious”, “Malignant” and “Information missing”. Internationally......, The Bethesda Classification System (TBCS) is increasingly accepted, especially owing to a detailed specification of FNA suspicious for malignancy. The Danish “Suspicious” group is very broad and includes atypia, follicular neoplasia and FNA suspicious of other malignancies. The purpose of this study...... risk of 36.4%, 13.3%, 17.2%, 16.1%, 55.3% and 88.2%, respectively. CONCLUSIONS: The Danish “Suspicious” group contains a broad spectrum of BG with varying malignancy risk. The results indicate a need for standardisation of the Danish FNA classification. A national introduction of the TBCS might secure...

  11. A model for anomaly classification in intrusion detection systems

    Science.gov (United States)

    Ferreira, V. O.; Galhardi, V. V.; Gonçalves, L. B. L.; Silva, R. C.; Cansian, A. M.

    2015-09-01

    Intrusion Detection Systems (IDS) are traditionally divided into two types according to the detection methods they employ, namely (i) misuse detection and (ii) anomaly detection. Anomaly detection has been widely used and its main advantage is the ability to detect new attacks. However, the analysis of anomalies generated can become expensive, since they often have no clear information about the malicious events they represent. In this context, this paper presents a model for automated classification of alerts generated by an anomaly based IDS. The main goal is either the classification of the detected anomalies in well-defined taxonomies of attacks or to identify whether it is a false positive misclassified by the IDS. Some common attacks to computer networks were considered and we achieved important results that can equip security analysts with best resources for their analyses.

  12. Promoting consistent use of the communication function classification system (CFCS).

    Science.gov (United States)

    Cunningham, Barbara Jane; Rosenbaum, Peter; Hidecker, Mary Jo Cooley

    2016-01-01

    We developed a Knowledge Translation (KT) intervention to standardize the way speech-language pathologists working in Ontario Canada's Preschool Speech and Language Program (PSLP) used the Communication Function Classification System (CFCS). This tool was being used as part of a provincial program evaluation and standardizing its use was critical for establishing reliability and validity within the provincial dataset. Two theoretical foundations - Diffusion of Innovations and the Communication Persuasion Matrix - were used to develop and disseminate the intervention to standardize use of the CFCS among a cohort speech-language pathologists. A descriptive pre-test/post-test study was used to evaluate the intervention. Fifty-two participants completed an electronic pre-test survey, reviewed intervention materials online, and then immediately completed an electronic post-test survey. The intervention improved clinicians' understanding of how the CFCS should be used, their intentions to use the tool in the standardized way, and their abilities to make correct classifications using the tool. Findings from this work will be shared with representatives of the Ontario PSLP. The intervention may be disseminated to all speech-language pathologists working in the program. This study can be used as a model for developing and disseminating KT interventions for clinicians in paediatric rehabilitation. The Communication Function Classification System (CFCS) is a new tool that allows speech-language pathologists to classify children's skills into five meaningful levels of function. There is uncertainty and inconsistent practice in the field about the methods for using this tool. This study used combined two theoretical frameworks to develop an intervention to standardize use of the CFCS among a cohort of speech-language pathologists. The intervention effectively increased clinicians' understanding of the methods for using the CFCS, ability to make correct classifications, and

  13. CLASSIFICATION OF THE MGR DISPOSAL CONTAINER HANDLING SYSTEM

    Energy Technology Data Exchange (ETDEWEB)

    S.E. Salzman

    1999-08-31

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) disposal container handling system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-O333P, ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998).

  14. DNA methylation-based classification of central nervous system tumours

    DEFF Research Database (Denmark)

    Capper, David; Jones, David T.W.; Sill, Martin

    2018-01-01

    Accurate pathological diagnosis is crucial for optimal management of patients with cancer. For the approximately 100 known tumour types of the central nervous system, standardization of the diagnostic process has been shown to be particularly challenging - with substantial inter......-observer variability in the histopathological diagnosis of many tumour types. Here we present a comprehensive approach for the DNA methylation-based classification of central nervous system tumours across all entities and age groups, and demonstrate its application in a routine diagnostic setting. We show...

  15. Classification of Headache Disorders: Extending to a Multiaxial System.

    Science.gov (United States)

    Martin, Paul R

    2016-11-01

    This article argues for extending the International Classification of Headache Disorders to include information that goes beyond diagnosis. The obvious model is a multiaxial system as has been developed for other taxonomies. An axis for recording disability and impact on functioning, and an axis for recording the triggers of headache/migraine, are perhaps the strongest contenders for adding to the system, but there are other possibilities such as lifestyle factors relevant to headache. Extensions such as these would contribute to headache management, provide clear targets for change, and encourage adoption of a biopsychosocial perspective. © 2016 American Headache Society.

  16. Sub system and component level safety classification evaluation and identification for tank farm safety systems

    International Nuclear Information System (INIS)

    JANICEK, G.P.

    2001-01-01

    This document provides the safety classification, and classification rationale, for all elements of (some) Tank Farm Safety Systems identified in the Tank Farms Final Safety Analyses. It also contains the official Safety Equipment List (SEL) for the safety systems evaluated. The initial issue of this document does not address all Tank Farm safety systems. The remainder will be addressed, and incorporated in this document, in subsequent revisions

  17. The roles of patents and research and development incentives in biopharmaceutical innovation.

    Science.gov (United States)

    Grabowski, Henry G; DiMasi, Joseph A; Long, Genia

    2015-02-01

    Patents and other forms of intellectual property protection play essential roles in encouraging innovation in biopharmaceuticals. As part of the "21st Century Cures" initiative, Congress is reviewing the policy mechanisms designed to accelerate the discovery, development, and delivery of new treatments. Debate continues about how best to balance patent and intellectual property incentives to encourage innovation, on the one hand, and generic utilization and price competition, on the other hand. We review the current framework for accomplishing these dual objectives and the important role of patents and regulatory exclusivity (together, the patent-based system), given the lengthy, costly, and risky biopharmaceutical research and development process. We summarize existing targeted incentives, such as for orphan drugs and neglected diseases, and we consider the pros and cons of proposed voluntary or mandatory alternatives to the patent-based system, such as prizes and government research and development contracting. We conclude that patents and regulatory exclusivity provisions are likely to remain the core approach to providing incentives for biopharmaceutical research and development. However, prizes and other voluntary supplements could play a useful role in addressing unmet needs and gaps in specific circumstances. Project HOPE—The People-to-People Health Foundation, Inc.

  18. Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities.

    Science.gov (United States)

    Garcia, Fernando A; Vandiver, Michael W

    2017-01-01

    In order to operate profitably under different product demand scenarios, biopharmaceutical companies must design their facilities with mass output flexibility in mind. Traditional biologics manufacturing technologies pose operational challenges in this regard due to their high costs and slow equipment turnaround times, restricting the types of products and mass quantities that can be processed. Modern plant design, however, has facilitated the development of lean and efficient bioprocessing facilities through footprint reduction and adoption of disposable and continuous manufacturing technologies. These development efforts have proven to be crucial in seeking to drastically reduce the high costs typically associated with the manufacturing of recombinant proteins. In this work, mathematical modeling is used to optimize annual production schedules for a single-product commercial facility operating with a continuous upstream and discrete batch downstream platform. Utilizing cell culture duration and volumetric productivity as process variables in the model, and annual plant throughput as the optimization objective, 3-D surface plots are created to understand the effect of process and facility design on expected mass output. The model shows that once a plant has been fully debottlenecked it is capable of processing well over a metric ton of product per year. Moreover, the analysis helped to uncover a major limiting constraint on plant performance, the stability of the neutralized viral inactivated pool, which may indicate that this should be a focus of attention during future process development efforts. LAY ABSTRACT: Biopharmaceutical process modeling can be used to design and optimize manufacturing facilities and help companies achieve a predetermined set of goals. One way to perform optimization is by making the most efficient use of process equipment in order to minimize the expenditure of capital, labor and plant resources. To that end, this paper introduces a

  19. Neighborhood Hypergraph Based Classification Algorithm for Incomplete Information System

    Directory of Open Access Journals (Sweden)

    Feng Hu

    2015-01-01

    Full Text Available The problem of classification in incomplete information system is a hot issue in intelligent information processing. Hypergraph is a new intelligent method for machine learning. However, it is hard to process the incomplete information system by the traditional hypergraph, which is due to two reasons: (1 the hyperedges are generated randomly in traditional hypergraph model; (2 the existing methods are unsuitable to deal with incomplete information system, for the sake of missing values in incomplete information system. In this paper, we propose a novel classification algorithm for incomplete information system based on hypergraph model and rough set theory. Firstly, we initialize the hypergraph. Second, we classify the training set by neighborhood hypergraph. Third, under the guidance of rough set, we replace the poor hyperedges. After that, we can obtain a good classifier. The proposed approach is tested on 15 data sets from UCI machine learning repository. Furthermore, it is compared with some existing methods, such as C4.5, SVM, NavieBayes, and KNN. The experimental results show that the proposed algorithm has better performance via Precision, Recall, AUC, and F-measure.

  20. Comparison of an automated classification system with an empirical classification of circulation patterns over the Pannonian basin, Central Europe

    Science.gov (United States)

    Maheras, Panagiotis; Tolika, Konstantia; Tegoulias, Ioannis; Anagnostopoulou, Christina; Szpirosz, Klicász; Károssy, Csaba; Makra, László

    2018-04-01

    The aim of the study is to compare the performance of the two classification methods, based on the atmospheric circulation types over the Pannonian basin in Central Europe. Moreover, relationships including seasonal occurrences and correlation coefficients, as well as comparative diagrams of the seasonal occurrences of the circulation types of the two classification systems are presented. When comparing of the automated (objective) and empirical (subjective) classification methods, it was found that the frequency of the empirical anticyclonic (cyclonic) types is much higher (lower) than that of the automated anticyclonic (cyclonic) types both on an annual and seasonal basis. The highest and statistically significant correlations between the circulation types of the two classification systems, as well as those between the cumulated seasonal anticyclonic and cyclonic types occur in winter for both classifications, since the weather-influencing effect of the atmospheric circulation in this season is the most prevalent. Precipitation amounts in Budapest display a decreasing trend in accordance with the decrease in the occurrence of the automated cyclonic types. In contrast, the occurrence of the empirical cyclonic types displays an increasing trend. There occur types in a given classification that are usually accompanied by high ratios of certain types in the other classification.

  1. Reporting ureteroscopy complications using the modified clavien classification system

    Directory of Open Access Journals (Sweden)

    Ahmed Khalil Ibrahim

    2015-01-01

    Full Text Available Objective: Perioperative complications are one of the surrogate indicators of surgical outcomes. However, reporting these complications need a precise grading system. Our aim is to report and grade the complications of semirigid ureteroscopy in ureteral stone management according to the modified Clavien classification system. Materials and Methods: This is a prospective study conducted From January 2012 to June 2013. All patients with ureteral stones who were indicated for semirigid URS were evaluated. All procedures were performed by the same surgeon. The data recorded including patient demographics, clinical indication, stone size and location, operative time and complications were classified according to the modified Clavien classification system. The patients were followed for 8 weeks postoperatively. Results: 148 patients included, Stone distribution was: 89 (60.1% lower ureteral, 26 (17.6% mid ureteral, and 33 (22.3% upper ureteral. the mean stone size was 8.6 mm. Urgent URS done in 23% of patient. The overall stone free rate was 88.5%, the individual stone free rate for the upper, middle and lower ureter were 87.9%, 84.6%, and 89.9%, respectively. The mean operative time was 31.9 min (20-50 min.. Complications occurred in 26.35% of patients. Grade I complications occurred in 32 patients (26.1%, grade II in 9 (6.1%, grade IIIa in 7 (4.7%, grade IIIb in 8 (5.4%, grade IVa in two patient (1.35%, and grade IVb in one patient (0.7%. No grade V complication was encountered. Conclusion: Ureteroscopy becomes the vanguard interventional therapy for ureteral stones with well-established efficacy and safety. It is of paramount importance to adopt a precise structured classification system for reporting surgical complications, that should be flexible and comprehensive in order to accommodate the various and rapidly expanding surgical fields.

  2. The influence of spine surgeons' experience on the classification and intraobserver reliability of the novel AOSpine thoracolumbar spine injury classification system : an international study

    NARCIS (Netherlands)

    Sadiqi, Said; Oner, F. Cumhur; Dvorak, Marcel F.; Aarabi, Bizhan; Schroeder, Gregory D.; Vaccaro, Alexander R.

    2015-01-01

    Study Design. International validation study. Objective. To investigate the influence of the spine surgeons' level of experience on the intraobserver reliability of the novel AOSpine Thoracolumbar Spine Injury Classification system, and the appropriate classification according to this system.

  3. Computer aided decision support system for cervical cancer classification

    Science.gov (United States)

    Rahmadwati, Rahmadwati; Naghdy, Golshah; Ros, Montserrat; Todd, Catherine

    2012-10-01

    Conventional analysis of a cervical histology image, such a pap smear or a biopsy sample, is performed by an expert pathologist manually. This involves inspecting the sample for cellular level abnormalities and determining the spread of the abnormalities. Cancer is graded based on the spread of the abnormal cells. This is a tedious, subjective and time-consuming process with considerable variations in diagnosis between the experts. This paper presents a computer aided decision support system (CADSS) tool to help the pathologists in their examination of the cervical cancer biopsies. The main aim of the proposed CADSS system is to identify abnormalities and quantify cancer grading in a systematic and repeatable manner. The paper proposes three different methods which presents and compares the results using 475 images of cervical biopsies which include normal, three stages of pre cancer, and malignant cases. This paper will explore various components of an effective CADSS; image acquisition, pre-processing, segmentation, feature extraction, classification, grading and disease identification. Cervical histological images are captured using a digital microscope. The images are captured in sufficient resolution to retain enough information for effective classification. Histology images of cervical biopsies consist of three major sections; background, stroma and squamous epithelium. Most diagnostic information are contained within the epithelium region. This paper will present two levels of segmentations; global (macro) and local (micro). At the global level the squamous epithelium is separated from the background and stroma. At the local or cellular level, the nuclei and cytoplasm are segmented for further analysis. Image features that influence the pathologists' decision during the analysis and classification of a cervical biopsy are the nuclei's shape and spread; the ratio of the areas of nuclei and cytoplasm as well as the texture and spread of the abnormalities

  4. Biopharmaceutical potentials of Prosopis spp. (Mimosaceae, Leguminosa

    Directory of Open Access Journals (Sweden)

    Santhaseelan Henciya

    2017-01-01

    Full Text Available Prosopis is a commercially important plant genus, which has been used since ancient times, particularly for medicinal purposes. Traditionally, Paste, gum, and smoke from leaves and pods are applied for anticancer, antidiabetic, anti-inflammatory, and antimicrobial purposes. Components of Prosopis such as flavonoids, tannins, alkaloids, quinones, or phenolic compounds demonstrate potentials in various biofunctions, such as analgesic, anthelmintic, antibiotic, antiemetic, microbial antioxidant, antimalarial, antiprotozoal, antipustule, and antiulcer activities; enhancement of H+, K+, ATPases; oral disinfection; and probiotic and nutritional effects; as well as in other biopharmaceutical applications, such as binding abilities for tablet production. The compound juliflorine provides a cure in Alzheimer disease by inhibiting acetylcholine esterase at cholinergic brain synapses. Some indirect medicinal applications of Prosopis spp. are indicated, including antimosquito larvicidal activity, chemical synthesis by associated fungal or bacterial symbionts, cyanobacterial degradation products, “mesquite” honey and pollens with high antioxidant activity, etc. This review will reveal the origins, distribution, folk uses, chemical components, biological functions, and applications of different representatives of Prosopis.

  5. Biopharmaceutical potentials of Prosopis spp. (Mimosaceae, Leguminosa).

    Science.gov (United States)

    Henciya, Santhaseelan; Seturaman, Prabha; James, Arthur Rathinam; Tsai, Yi-Hong; Nikam, Rahul; Wu, Yang-Chang; Dahms, Hans-Uwe; Chang, Fang Rong

    2017-01-01

    Prosopis is a commercially important plant genus, which has been used since ancient times, particularly for medicinal purposes. Traditionally, Paste, gum, and smoke from leaves and pods are applied for anticancer, antidiabetic, anti-inflammatory, and antimicrobial purposes. Components of Prosopis such as flavonoids, tannins, alkaloids, quinones, or phenolic compounds demonstrate potentials in various biofunctions, such as analgesic, anthelmintic, antibiotic, antiemetic, microbial antioxidant, antimalarial, antiprotozoal, antipustule, and antiulcer activities; enhancement of H + , K + , ATPases; oral disinfection; and probiotic and nutritional effects; as well as in other biopharmaceutical applications, such as binding abilities for tablet production. The compound juliflorine provides a cure in Alzheimer disease by inhibiting acetylcholine esterase at cholinergic brain synapses. Some indirect medicinal applications of Prosopis spp. are indicated, including antimosquito larvicidal activity, chemical synthesis by associated fungal or bacterial symbionts, cyanobacterial degradation products, "mesquite" honey and pollens with high antioxidant activity, etc. This review will reveal the origins, distribution, folk uses, chemical components, biological functions, and applications of different representatives of Prosopis. Copyright © 2016. Published by Elsevier B.V.

  6. In vitro display technologies reveal novel biopharmaceutics.

    Science.gov (United States)

    Rothe, Achim; Hosse, Ralf J; Power, Barbara E

    2006-08-01

    Display technologies are fundamental to the isolation of specific high-affinity binding proteins for diagnostic and therapeutic applications in cancer, neurodegenerative, and infectious diseases as well as autoimmune and inflammatory disorders. Applications extend into the broad field of antibody (Ab) engineering, synthetic enzymes, proteomics, and cell-free protein synthesis. Recently, in vitro display technologies have come to prominence due to the isolation of high-affinity human antibodies by phage display, the development of novel scaffolds for ribosome display, and the discovery of novel protein-protein interactions. In vitro display represents an emerging and innovative technology for the rapid isolation and evolution of high-affinity peptides and proteins. So far, only one clinical drug candidate produced by in vitro display technology has been approved by the FDA for use in humans, but several are in clinical or preclinical testing. This review highlights recent advances in various engineered biopharmaceutical products isolated by in vitro display with a focus on the commercial developments.

  7. A neuromorphic system for object detection and classification

    Science.gov (United States)

    Khosla, Deepak; Chen, Yang; Kim, Kyungnam; Cheng, Shinko Y.; Honda, Alexander L.; Zhang, Lei

    2013-05-01

    Unattended object detection, recognition and tracking on unmanned reconnaissance platforms in battlefields and urban spaces are topics of emerging importance. In this paper, we present an unattended object recognition system that automatically detects objects of interest in videos and classifies them into various categories (e.g., person, car, truck, etc.). Our system is inspired by recent findings in visual neuroscience on feed-forward object detection and recognition pipeline and mirrors that via two main neuromorphic modules (1) A front-end detection module that combines form and motion based visual attention to search for and detect "integrated" object percepts as is hypothesized to occur in the human visual pathways; (2) A back-end recognition module that processes only the detected object percepts through a neuromorphic object classification algorithm based on multi-scale convolutional neural networks, which can be efficiently implemented in COTS hardware. Our neuromorphic system was evaluated using a variety of urban area video data collected from both stationary and moving platforms. The data are quite challenging as it includes targets at long ranges, occurring under variable conditions of illuminations and occlusion with high clutter. The experimental results of our system showed excellent detection and classification performance. In addition, the proposed bio-inspired approach is good for hardware implementation due to its low complexity and mapping to off-the-shelf conventional hardware.

  8. Interobserver reliability of the Schatzker and Luo classification systems for tibial plateau fractures

    NARCIS (Netherlands)

    Mellema, Jos J.; Doornberg, Job N.; Molenaars, Rik J.; Ring, David; Kloen, Peter; Babis, George C.; Jeray, Kyle J.; Prayson, Michael J.; Pesantez, Rodrigo; Acacio, Ramos; Verbeek, Diederik O.; Melvanki, Parag; Kreis, Barbara E.; Mehta, Samir; Meylaerts, S.; Wojtek, S.; Yeap, Ewe J.; Haapasalo, Heidi; Kristan, Anž e; Coles, Chad; Marsh, J. Lawrence; Mormino, Matthew; Menon, Matthew; Tyllianakis, Minos; Schandelmaier, Peter; Jenkinson, R. J.; Neuhaus, Valentin; Shahriar, Chegini M. H.; Belangero, William D.; Kannan, S. G.; Leonidovich, Golovakha M.; Davenport, J. H.; Kabir, Koroush; Althausen, Peter L.; Weil, Yoram; Toom, Alar; Sa da Costa, Daniel; Lijoi, F.; Koukoulias, Nikolaos E.; Manidakis, Nikolaos; van den Bogaert, Max; Patczai, Balá zs; Grauls, Anthony; Kurup, Harish; van den Bekerom, Michel P.; Lansdaal, Joris R.; Vale, M.á rio; Ousema, Paul; Barquet, Antonio; Cross, Brian J.; Broekhuyse, Henry; Haverkamp, Daniel; Merchant, Milind; Harvey, Edward; Stojkovska Pemovska, Emilija; Frihagen, Frede; Seibert, Franz J.; Garnavos, Christos; van der Heide, Huub; Villamizar, Harold A.; Harris, Ian; Borris, Lars C.; Brink, Ole; Brink, Peter R. G.; Choudhari, Pradeep; Swiontkowski, Marc; Mittlmeier, Thomas; Tosounidis, Theodoros; van Rensen, Inge; Martinelli, N.; Park, D. H.; Lasanianos, Nikolaos; Vide, J.; Engvall, A.; Zura, R. D.; Jubel, Axel; Kawaguchi, Alan; Goost, Hans; Bishop, Julius; Mica, Ladislav; Pirpiris, Marinis; van Helden, S. H.; Bouaicha, Samy; Schepers, T.; Havlič ek, Tomo; Giordano, Vincenzo

    2016-01-01

    Tibial plateau fracture classification systems have limited interobserver reliability and new systems emerge. The purpose of this study was to compare the reliability of the Luo classification and the Schatzker classification for two-dimensional computed tomography (2DCT) and to study the effect of

  9. Classification of time series patterns from complex dynamic systems

    Energy Technology Data Exchange (ETDEWEB)

    Schryver, J.C.; Rao, N.

    1998-07-01

    An increasing availability of high-performance computing and data storage media at decreasing cost is making possible the proliferation of large-scale numerical databases and data warehouses. Numeric warehousing enterprises on the order of hundreds of gigabytes to terabytes are a reality in many fields such as finance, retail sales, process systems monitoring, biomedical monitoring, surveillance and transportation. Large-scale databases are becoming more accessible to larger user communities through the internet, web-based applications and database connectivity. Consequently, most researchers now have access to a variety of massive datasets. This trend will probably only continue to grow over the next several years. Unfortunately, the availability of integrated tools to explore, analyze and understand the data warehoused in these archives is lagging far behind the ability to gain access to the same data. In particular, locating and identifying patterns of interest in numerical time series data is an increasingly important problem for which there are few available techniques. Temporal pattern recognition poses many interesting problems in classification, segmentation, prediction, diagnosis and anomaly detection. This research focuses on the problem of classification or characterization of numerical time series data. Highway vehicles and their drivers are examples of complex dynamic systems (CDS) which are being used by transportation agencies for field testing to generate large-scale time series datasets. Tools for effective analysis of numerical time series in databases generated by highway vehicle systems are not yet available, or have not been adapted to the target problem domain. However, analysis tools from similar domains may be adapted to the problem of classification of numerical time series data.

  10. A complete electrical hazard classification system and its application

    Energy Technology Data Exchange (ETDEWEB)

    Gordon, Lloyd B [Los Alamos National Laboratory; Cartelli, Laura [Los Alamos National Laboratory

    2009-01-01

    The Standard for Electrical Safety in the Workplace, NFPA 70E, and relevant OSHA electrical safety standards evolved to address the hazards of 60-Hz power that are faced primarily by electricians, linemen, and others performing facility and utility work. This leaves a substantial gap in the management of electrical hazards in Research and Development (R&D) and specialized high voltage and high power equipment. Examples include lasers, accelerators, capacitor banks, electroplating systems, induction and dielectric heating systems, etc. Although all such systems are fed by 50/60 Hz alternating current (ac) power, we find substantial use of direct current (dc) electrical energy, and the use of capacitors, inductors, batteries, and radiofrequency (RF) power. The electrical hazards of these forms of electricity and their systems are different than for 50160 Hz power. Over the past 10 years there has been an effort to develop a method of classifying all of the electrical hazards found in all types of R&D and utilization equipment. Examples of the variation of these hazards from NFPA 70E include (a) high voltage can be harmless, if the available current is sufficiently low, (b) low voltage can be harmful if the available current/power is high, (c) high voltage capacitor hazards are unique and include severe reflex action, affects on the heart, and tissue damage, and (d) arc flash hazard analysis for dc and capacitor systems are not provided in existing standards. This work has led to a comprehensive electrical hazard classification system that is based on various research conducted over the past 100 years, on analysis of such systems in R&D, and on decades of experience. Initially, national electrical safety codes required the qualified worker only to know the source voltage to determine the shock hazard. Later, as arc flash hazards were understood, the fault current and clearing time were needed. These items are still insufficient to fully characterize all types of

  11. Fault Tolerant Neural Network for ECG Signal Classification Systems

    Directory of Open Access Journals (Sweden)

    MERAH, M.

    2011-08-01

    Full Text Available The aim of this paper is to apply a new robust hardware Artificial Neural Network (ANN for ECG classification systems. This ANN includes a penalization criterion which makes the performances in terms of robustness. Specifically, in this method, the ANN weights are normalized using the auto-prune method. Simulations performed on the MIT ? BIH ECG signals, have shown that significant robustness improvements are obtained regarding potential hardware artificial neuron failures. Moreover, we show that the proposed design achieves better generalization performances, compared to the standard back-propagation algorithm.

  12. Classification analysis of organization factors related to system safety

    International Nuclear Information System (INIS)

    Liu Huizhen; Zhang Li; Zhang Yuling; Guan Shihua

    2009-01-01

    This paper analyzes the different types of organization factors which influence the system safety. The organization factor can be divided into the interior organization factor and exterior organization factor. The latter includes the factors of political, economical, technical, law, social culture and geographical, and the relationships among different interest groups. The former includes organization culture, communication, decision, training, process, supervision and management and organization structure. This paper focuses on the description of the organization factors. The classification analysis of the organization factors is the early work of quantitative analysis. (authors)

  13. Intra- and Interobserver Reliability of Three Classification Systems for Hallux Rigidus.

    Science.gov (United States)

    Dillard, Sarita; Schilero, Christina; Chiang, Sharon; Pham, Peter

    2018-04-18

    There are over ten classification systems currently used in the staging of hallux rigidus. This results in confusion and inconsistency with radiographic interpretation and treatment. The reliability of hallux rigidus classification systems has not yet been tested. The purpose of this study was to evaluate intra- and interobserver reliability using three commonly used classifications for hallux rigidus. Twenty-one plain radiograph sets were presented to ten ACFAS board-certified foot and ankle surgeons. Each physician classified each radiograph based on clinical experience and knowledge according to the Regnauld, Roukis, and Hattrup and Johnson classification systems. The two-way mixed single-measure consistency intraclass correlation was used to calculate intra- and interrater reliability. The intrarater reliability of individual sets for the Roukis and Hattrup and Johnson classification systems was "fair to good" (Roukis, 0.62±0.19; Hattrup and Johnson, 0.62±0.28), whereas the intrarater reliability of individual sets for the Regnauld system bordered between "fair to good" and "poor" (0.43±0.24). The interrater reliability of the mean classification was "excellent" for all three classification systems. Conclusions Reliable and reproducible classification systems are essential for treatment and prognostic implications in hallux rigidus. In our study, Roukis classification system had the best intrarater reliability. Although there are various classification systems for hallux rigidus, our results indicate that all three of these classification systems show reliability and reproducibility.

  14. Soybeans as bioreactors for biopharmaceuticals and industrial proteins.

    Science.gov (United States)

    Vianna, G R; Cunha, N B; Murad, A M; Rech, E L

    2011-01-01

    Plants present various advantages for the production of biomolecules, including low risk of contamination with prions, viruses and other pathogens, scalability, low production costs, and available agronomical systems. Plants are also versatile vehicles for the production of recombinant molecules because they allow protein expression in various organs, such as tubers and seeds, which naturally accumulate large amounts of protein. Among crop plants, soybean is an excellent protein producer. Soybean plants are also a good source of abundant and cheap biomass and can be cultivated under controlled greenhouse conditions. Under containment, the plant cycle can be manipulated and the final seed yield can be maximized for large-scale protein production within a small and controlled area. Exploitation of specific regulatory sequences capable of directing and accumulating recombinant proteins in protein storage vacuoles in soybean seeds, associated with recently developed biological research tools and purification systems, has great potential to accelerate preliminary characterization of plant-derived biopharmaceuticals and industrial macromolecules. This is an important step in the development of genetically engineered products that are inexpensive and safe for medicinal, food and other uses.

  15. Hairy roots culture as a source of valuable biopharmaceuticals

    Directory of Open Access Journals (Sweden)

    Tomasz Kowalczyk

    2016-01-01

    Full Text Available Plants have been exploited as a source of medicinal substances for years. Nowadays, achievements of modern science, including molecular biotechnology, allow their huge potential to be utilized. They have become a promising platform for the production of valuable compounds such as biopharmaceuticals. Among the various plant systems used for this purpose, hairy root cultures are also applied for the production of recombinant proteins and secondary metabolites. For this purpose plant cells of selected species are genetically transformed using different strains of Agrobacterium rhizogenes carrying the desired genes. The next steps of this process include stable and efficient expression of these genes. Hairy root cultures exhibit a number of features which make them attractive compared to various pro- and eukaryotic cell systems including other plant models. Their main advantages are: relatively low production costs, ease of scale-up, production of compounds typical for eukaryotic cells with post-translational modifications, biological safety, and in many cases there is no need for complex purification techniques of the final product. Several compounds that are successfully obtained using this production strategy are valuable pharmaceuticals. This group includes selected cytokines, vaccine antigens and antibodies.

  16. Changing tides: increasing evidence to embrace a patient classification system.

    Science.gov (United States)

    Malloch, Kathy

    2012-01-01

    The effective use of a patient classification system (PCS) in a way that provides value to all health care organizations has yet to be realized given the challenging developmental pathway of these systems. As the science and technology of workforce management emerges along with evidence to support the relationships between nurse work and patient care needs, it is no longer appropriate to rely on systems that provide aggregated and minimal data to address the need for safer patient care and retention of nurses. Specificity about patient care needs in a valid and reliable PCS is essential on our pathway to improved resource utilization, improved decision making, integration of nurse cognitive and knowledge work, and management of variances from planned resource use. Advancements with technology, the ability to create and monitor equitable nurse-patient assignments, conceptual clarity, evidence, regulatory requirements, and professional role development point to a new receptiveness for PCSs.

  17. Value of the revised Atlanta classification (RAC) and determinant-based classification (DBC) systems in the evaluation of acute pancreatitis.

    Science.gov (United States)

    Wang, Xiaolei; Qin, Li; Cao, Jingli

    2017-11-03

    Since increasing acute pancreatitis (AP) severity is significantly associated with mortality, accurate and rapid determination of severity is crucial for effective clinical management. This study investigated the value of the revised Atlanta classification (RAC) and the determinant-based classification (DBC) systems in stratifying severity of acute pancreatitis. This retrospective observational cohort study included 480 AP patients. Patient demographics and clinical characteristics were recorded. The primary outcome was mortality, and secondary outcomes were admission to intensive care unit (ICU), duration of ICU stay, and duration of hospital stay. Based on the RAC classification, there were 295 patients with mild AP (MAP), 146 patients with moderate-to-severe AP (MSAP), and 39 patients with severe AP (SAP). Based on the DBC classification, there were 389 patients with MAP, 41 patients with MSAP, 32 patients with SAP, and 18 patients with critical AP (CAP). ROC curve analysis showed that the DBC system had a significantly higher accuracy at predicting organ failure compared to the RAC system (p < .001). Multivariate regression analysis showed that age and ICU stay were independent risk factors of mortality. The DBC system had a higher accuracy at predicting organ failure. Age and ICU stay were significantly associated with risk of death in AP patients. A classification of CAP by the DBC system should warrant close attention, and rapid implementation of effective measures to reduce mortality.

  18. A data-stream classification system for investigating terrorist threats

    Science.gov (United States)

    Schulz, Alexia; Dettman, Joshua; Gottschalk, Jeffrey; Kotson, Michael; Vuksani, Era; Yu, Tamara

    2016-05-01

    The role of cyber forensics in criminal investigations has greatly increased in recent years due to the wealth of data that is collected and available to investigators. Physical forensics has also experienced a data volume and fidelity revolution due to advances in methods for DNA and trace evidence analysis. Key to extracting insight is the ability to correlate across multi-modal data, which depends critically on identifying a touch-point connecting the separate data streams. Separate data sources may be connected because they refer to the same individual, entity or event. In this paper we present a data source classification system tailored to facilitate the investigation of potential terrorist activity. This taxonomy is structured to illuminate the defining characteristics of a particular terrorist effort and designed to guide reporting to decision makers that is complete, concise, and evidence-based. The classification system has been validated and empirically utilized in the forensic analysis of a simulated terrorist activity. Next-generation analysts can use this schema to label and correlate across existing data streams, assess which critical information may be missing from the data, and identify options for collecting additional data streams to fill information gaps.

  19. Gender and cultural issues in psychiatric nosological classification systems.

    Science.gov (United States)

    van de Water, Tanya; Suliman, Sharain; Seedat, Soraya

    2016-08-01

    Much has changed since the two dominant mental health nosological systems, the International Classification of Diseases (ICD) and the Diagnostic and Statistical Manual of Mental Disorders (DSM), were first published in 1900 and 1952, respectively. Despite numerous modifications to stay up to date with scientific and cultural changes (eg, exclusion of homosexuality as a disorder) and to improve the cultural sensitivity of psychiatric diagnoses, the ICD and DSM have only recently renewed attempts at harmonization. Previous nosological iterations demonstrate the oscillation in the importance placed on the biological focus, highlighting the tension between a gender- and culture-free nosology (solely biological) and a contextually relevant understanding of mental illness. In light of the release of the DSM 5, future nosological systems, such as the ICD 11, scheduled for release in 2017, and the Research Development Criteria (RDoC), can learn from history and apply critiques. This article aims to critically consider gender and culture in previous editions of the ICD and DSM to inform forthcoming classifications.

  20. Tangata whaiora/consumers perspectives on current psychiatric classification systems

    Directory of Open Access Journals (Sweden)

    Wells Debra

    2008-06-01

    Full Text Available Abstract Background A number of studies have been undertaken with the aim of considering the utility of mental health classification systems from the perspective of a variety of stakeholders. There is a lack of research on how useful consumers/tangata whaiora think these are in assisting them in their recovery. Methods Seventy service users were involved in seven focus groups in order to consider this question. Results and discussion While for clinicians diagnosing someone might be a discrete event and easily forgotten as a moment in a busy schedule, most people in this study remembered the occasion and aftermath very clearly. The overall consensus was that whether being 'diagnosed' was helpful or not, in large part, depended on how the process happened and what resulted from being 'labeled' in the person's life. Conclusion Overall, people thought that in terms of their recovery, the classification systems were tools and their utility depended on how they were used. They suggested that whatever tool was used it needed to help them make sense of their distress and provide them with a variety of supports, not just medication, to assist them to live lives that were meaningful to them.

  1. Derivation and Validation of Systemic Lupus International Collaborating Clinics Classification Criteria for Systemic Lupus Erythematosus

    Science.gov (United States)

    Petri, Michelle; Orbai, Ana-Maria; Alarcón, Graciela S.; Gordon, Caroline; Merrill, Joan T.; Fortin, Paul R.; Bruce, Ian N.; Isenberg, David; Wallace, Daniel J.; Nived, Ola; Sturfelt, Gunnar; Ramsey-Goldman, Rosalind; Bae, Sang-Cheol; Hanly, John G.; Sanchez-Guerrero, Jorge; Clarke, Ann; Aranow, Cynthia; Manzi, Susan; Urowitz, Murray; Gladman, Dafna; Kalunian, Kenneth; Costner, Melissa; Werth, Victoria P.; Zoma, Asad; Bernatsky, Sasha; Ruiz-Irastorza, Guillermo; Khamashta, Munther A.; Jacobsen, Soren; Buyon, Jill P.; Maddison, Peter; Dooley, Mary Anne; van Vollenhoven, Ronald F.; Ginzler, Ellen; Stoll, Thomas; Peschken, Christine; Jorizzo, Joseph L.; Callen, Jeffrey P.; Lim, S. Sam; Fessler, Barri J.; Inanc, Murat; Kamen, Diane L.; Rahman, Anisur; Steinsson, Kristjan; Franks, Andrew G.; Sigler, Lisa; Hameed, Suhail; Fang, Hong; Pham, Ngoc; Brey, Robin; Weisman, Michael H.; McGwin, Gerald; Magder, Laurence S.

    2012-01-01

    Objective The Systemic Lupus Collaborating Clinics (SLICC) revised and validated the American College of Rheumatology (ACR) SLE classification criteria in order to improve clinical relevance, meet stringent methodology requirements and incorporate new knowledge in SLE immunology. Methods The classification criteria were derived from a set of 702 expert-rated patient scenarios. Recursive partitioning was used to derive an initial rule that was simplified and refined based on SLICC physician consensus. SLICC validated the classification criteria in a new validation sample of 690 SLE patients and controls. Results Seventeen criteria were identified. The SLICC criteria for SLE classification requires: 1) Fulfillment of at least four criteria, with at least one clinical criterion AND one immunologic criterion OR 2) Lupus nephritis as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies. In the derivation set, the SLICC classification criteria resulted in fewer misclassifications than the current ACR classification criteria (49 versus 70, p=0.0082), had greater sensitivity (94% versus 86%, p<0.0001) and equal specificity (92% versus 93%, p=0.39). In the validation set, the SLICC Classification criteria resulted in fewer misclassifications (62 versus 74, p=0.24), had greater sensitivity (97% versus 83%, p<0.0001) but less specificity (84% versus 96%, p<0.0001). Conclusions The new SLICC classification criteria performed well on a large set of patient scenarios rated by experts. They require that at least one clinical criterion and one immunologic criterion be present for a classification of SLE. Biopsy confirmed nephritis compatible with lupus (in the presence of SLE autoantibodies) is sufficient for classification. PMID:22553077

  2. A Game Player Expertise Level Classification System Using Electroencephalography (EEG

    Directory of Open Access Journals (Sweden)

    Syed Muhammad Anwar

    2017-12-01

    Full Text Available The success and wider adaptability of smart phones has given a new dimension to the gaming industry. Due to the wide spectrum of video games, the success of a particular game depends on how efficiently it is able to capture the end users’ attention. This leads to the need to analyse the cognitive aspects of the end user, that is the game player, during game play. A direct window to see how an end user responds to a stimuli is to look at their brain activity. In this study, electroencephalography (EEG is used to record human brain activity during game play. A commercially available EEG headset is used for this purpose giving fourteen channels of recorded EEG brain activity. The aim is to classify a player as expert or novice using the brain activity as the player indulges in the game play. Three different machine learning classifiers have been used to train and test the system. Among the classifiers, naive Bayes has outperformed others with an accuracy of 88 % , when data from all fourteen EEG channels are used. Furthermore, the activity observed on electrodes is statistically analysed and mapped for brain visualizations. The analysis has shown that out of the available fourteen channels, only four channels in the frontal and occipital brain regions show significant activity. Features of these four channels are then used, and the performance parameters of the four-channel classification are compared to the results of the fourteen-channel classification. It has been observed that support vector machine and the naive Bayes give good classification accuracy and processing time, well suited for real-time applications.

  3. A comparison of the validity and reliability of established bone stock loss classification systems and the proposal of a novel classification system.

    Science.gov (United States)

    Parry, Michael C; Whitehouse, Michael R; Mehendale, Sanchit A; Smith, Lindsay K; Webb, Jason C; Spencer, Robert F; Blom, Ashley W

    2010-01-01

    The classification and management of aseptic loosening of total hip arthroplasty remains a distinct challenge to the modern orthopaedic surgeon. The aim of this study was to assess the inter-observer and intra-observer reliability of commonly used classification systems for the assessment of bone stock loss in revision hip surgery. Radiographs of 23 femoral and 32 acetabular components in 30 patients were assessed using the Paprosky, AAOS and Endo-Klinik classification systems. A novel classification system was introduced and also used to assess the radiographs. Assessment was undertaken by 3 surgeons on 2 separate occasions and the inter- and intra- observer reliability calculated. The novel classification system showed a good to very good intra-observer reliability for both femoral and acetabular components (0.77-1.0; pstock loss in revision hip surgery.

  4. Development of a comprehensive radioactive waste classification system

    International Nuclear Information System (INIS)

    Smith, C.F.; Cohen, J.J.

    1989-01-01

    Several previous studies have been conducted with the intent of developing a rational system for classification of radioactive wastes. Although none of the proposed systems has gained general acceptance, certain waste classes, specifically high-level waste and low-level waste suitable for shallow land burial have been essentially defined by regulation. Wastes which remain undefined include: those intermediate level wastes which require more restrictive controls than that provided by shallow land burial but not the high degree of isolation needed for high level wastes, and wastes below regulatory concern (BRC) which entail so low a radiological risk that they can be managed according to their nonradiological properties. This study has developed a framework within which the complete spectrum of radioactive wastes can be defined

  5. A space-based classification system for RF transients

    Energy Technology Data Exchange (ETDEWEB)

    Moore, K.R.; Call, D.; Johnson, S.; Payne, T.; Ford, W.; Spencer, K.; Wilkerson, J.F. [Los Alamos National Lab., NM (United States); Baumgart, C. [EG and G, Inc., Los Alamos, NM (United States)

    1993-12-01

    The FORTE (Fast On-Orbit Recording of Transient Events) small satellite is scheduled for launch in mid 1995. The mission is to measure and classify VHF (30--300 MHz) electromagnetic pulses, primarily due to lightning, within a high noise environment dominated by continuous wave carriers such as TV and FM stations. The FORTE Event Classifier will use specialized hardware to implement signal processing and neural network algorithms that perform onboard classification of RF transients and carriers. Lightning events will also be characterized with optical data telemetered to the ground. A primary mission science goal is to develop a comprehensive understanding of the correlation between the optical flash and the VHF emissions from lightning. By combining FORTE measurements with ground measurements and/or active transmitters, other science issues can be addressed. Examples include the correlation of global precipitation rates with lightning flash rates and location, the effects of large scale structures within the ionosphere (such as traveling ionospheric disturbances and horizontal gradients in the total electron content) on the propagation of broad bandwidth RF signals, and various areas of lightning physics. Event classification is a key feature of the FORTE mission. Neural networks are promising candidates for this application. The authors describe the proposed FORTE Event Classifier flight system, which consists of a commercially available digital signal processing board and a custom board, and discuss work on signal processing and neural network algorithms.

  6. A space-based classification system for RF transients

    International Nuclear Information System (INIS)

    Moore, K.R.; Call, D.; Johnson, S.; Payne, T.; Ford, W.; Spencer, K.; Wilkerson, J.F.; Baumgart, C.

    1993-01-01

    The FORTE (Fast On-Orbit Recording of Transient Events) small satellite is scheduled for launch in mid 1995. The mission is to measure and classify VHF (30--300 MHz) electromagnetic pulses, primarily due to lightning, within a high noise environment dominated by continuous wave carriers such as TV and FM stations. The FORTE Event Classifier will use specialized hardware to implement signal processing and neural network algorithms that perform onboard classification of RF transients and carriers. Lightning events will also be characterized with optical data telemetered to the ground. A primary mission science goal is to develop a comprehensive understanding of the correlation between the optical flash and the VHF emissions from lightning. By combining FORTE measurements with ground measurements and/or active transmitters, other science issues can be addressed. Examples include the correlation of global precipitation rates with lightning flash rates and location, the effects of large scale structures within the ionosphere (such as traveling ionospheric disturbances and horizontal gradients in the total electron content) on the propagation of broad bandwidth RF signals, and various areas of lightning physics. Event classification is a key feature of the FORTE mission. Neural networks are promising candidates for this application. The authors describe the proposed FORTE Event Classifier flight system, which consists of a commercially available digital signal processing board and a custom board, and discuss work on signal processing and neural network algorithms

  7. Aneurysms of the superficial venous system: classification and treatment

    Directory of Open Access Journals (Sweden)

    Ronald G. Bush

    2014-11-01

    Full Text Available Superficial venous aneurysms are rarely described and they may remain indolent or become the source for pulmonary emboli. A system of classification and treatment protocol according to size and location is proposed. Three hundred thirty patients were evaluated for symptomatic venous disease (C2-C6 over a 2-year period. A proposed designation for venous aneurysm is described. Patients fulfilling this criterion are described in reference to site of involvement, histologic findings, and method of treatment. Five percent of patients met the criteria for venous aneurysm. Nine aneurysms of the greater saphenous vein were identified. Three aneurysms were proximal to the subterminal valve and the rest were distal. Six aneurysms of the anterior accessory greater saphenous vein (AAGSV were identified. Three aneurysms of the AAGSV spontaneously thrombosed. Two patients presented with aneurysms of the small saphenous vein. Histology revealed thickened intima, smooth muscle and adventitia. Aneurysm designation relates to diameter of normal and contiguous vein. All superficial venous aneurysms in close proximity to the junction of the femoral or popliteal vein should be ligated. Classification of venous aneurysms should include the AAGSV, which may present with spontaneous thrombosis.

  8. Correlation between Gross Motor Function Classification System and Communication Function Classification System in Children with Cerebral Palsy

    Directory of Open Access Journals (Sweden)

    Vindy Margaretha

    2017-06-01

    Full Text Available Background: Cerebral Palsy (CP is a group of movement and posture disorder commonly accompanied by comorbidities such as sensation, cognition, communication abnormalities and many more. This study aimed to identify the correlation between gross motor function(measured by Gross Motor Function Classification System, GMFCS and communication function (measured by Communication Function Classification System, CFCS in children with CP. Methods: Thirty six children with CP aged 0–12 years were examined. Samples were taken from Department of Physical Medicine and Rehabilitation Dr. Hasan Sadikin General Hospital Bandung on September to October 2015. Patients’ descriptive data, levels of GMFCS and CFCS were collected by the researcher and residents previously standardized. Kendall’s tau b correlation coefficient was used to analyze the inter-relationship between the GMFCS and CFCS. Results: Levels of GMFCS and CFCS in all samples were moderately correlated (r=0.405; p=0.004. In patients with spastic quadripledic type, correlation were found moderate(r=0.495; p=0.014. No significant correlation was found when CP spastic quadriplegic patients were excluded (r=0.048, p=0.829. Conclusions: Levels of GMFCS and CFCS should be described to provide the complete gross motor and communication picture of CP children.Gross motor function in a child with spastic quadriplegic CP might be correctly predicted from his/ her communication function and vice versa.   DOI: 10.15850/amj.v4n2.1092

  9. Pathohistological classification systems in gastric cancer: diagnostic relevance and prognostic value.

    Science.gov (United States)

    Berlth, Felix; Bollschweiler, Elfriede; Drebber, Uta; Hoelscher, Arnulf H; Moenig, Stefan

    2014-05-21

    Several pathohistological classification systems exist for the diagnosis of gastric cancer. Many studies have investigated the correlation between the pathohistological characteristics in gastric cancer and patient characteristics, disease specific criteria and overall outcome. It is still controversial as to which classification system imparts the most reliable information, and therefore, the choice of system may vary in clinical routine. In addition to the most common classification systems, such as the Laurén and the World Health Organization (WHO) classifications, other authors have tried to characterize and classify gastric cancer based on the microscopic morphology and in reference to the clinical outcome of the patients. In more than 50 years of systematic classification of the pathohistological characteristics of gastric cancer, there is no sole classification system that is consistently used worldwide in diagnostics and research. However, several national guidelines for the treatment of gastric cancer refer to the Laurén or the WHO classifications regarding therapeutic decision-making, which underlines the importance of a reliable classification system for gastric cancer. The latest results from gastric cancer studies indicate that it might be useful to integrate DNA- and RNA-based features of gastric cancer into the classification systems to establish prognostic relevance. This article reviews the diagnostic relevance and the prognostic value of different pathohistological classification systems in gastric cancer.

  10. USCS and the USDA Soil Classification System: Development of a Mapping Scheme

    Science.gov (United States)

    2015-03-01

    Examples of classification systems that follow this approach are the French Soil Reference System, USDA soil taxonomy , and the World Reference Base for...ER D C/ CR RE L TR -1 5- 4 UPRM and ERDC Educational and Research Internship Program USCS and the USDA Soil Classification System...acwc.sdp.sirsi.net/client/default. UPRM and ERDC Educational and Research Internship Program ERDC/CRREL TR-15-4 March 2015 USCS and the USDA Soil Classification

  11. Risk classification and uncertainty propagation for virtual water distribution systems

    International Nuclear Information System (INIS)

    Torres, Jacob M.; Brumbelow, Kelly; Guikema, Seth D.

    2009-01-01

    While the secrecy of real water distribution system data is crucial, it poses difficulty for research as results cannot be publicized. This data includes topological layouts of pipe networks, pump operation schedules, and water demands. Therefore, a library of virtual water distribution systems can be an important research tool for comparative development of analytical methods. A virtual city, 'Micropolis', has been developed, including a comprehensive water distribution system, as a first entry into such a library. This virtual city of 5000 residents is fully described in both geographic information systems (GIS) and EPANet hydraulic model frameworks. A risk classification scheme and Monte Carlo analysis are employed for an attempted water supply contamination attack. Model inputs to be considered include uncertainties in: daily water demand, seasonal demand, initial storage tank levels, the time of day a contamination event is initiated, duration of contamination event, and contaminant quantity. Findings show that reasonable uncertainties in model inputs produce high variability in exposure levels. It is also shown that exposure level distributions experience noticeable sensitivities to population clusters within the contaminant spread area. High uncertainties in exposure patterns lead to greater resources needed for more effective mitigation strategies.

  12. Classification systems in nursing : Formalizing nursing knowledge and implications for nursing information systems

    NARCIS (Netherlands)

    Goossen, WTF; Epping, PJMM; Abraham, IL

    The development of nursing information systems (NIS) is often hampered by the fact that nursing lacks a unified nursing terminology and classification system. Currently there exist various initiatives in this area. We address the question as to how current initiatives in the development of nursing

  13. From fault classification to fault tolerance for multi-agent systems

    CERN Document Server

    Potiron, Katia; Taillibert, Patrick

    2013-01-01

    Faults are a concern for Multi-Agent Systems (MAS) designers, especially if the MAS are built for industrial or military use because there must be some guarantee of dependability. Some fault classification exists for classical systems, and is used to define faults. When dependability is at stake, such fault classification may be used from the beginning of the system's conception to define fault classes and specify which types of faults are expected. Thus, one may want to use fault classification for MAS; however, From Fault Classification to Fault Tolerance for Multi-Agent Systems argues that

  14. An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies.

    Science.gov (United States)

    Morar-Mitrica, Sorina; Adams, Monica L; Crotts, George; Wurth, Christine; Ihnat, Peter M; Tabish, Tanvir; Antochshuk, Valentyn; DiLuzio, Willow; Dix, Daniel B; Fernandez, Jason E; Gupta, Kapil; Fleming, Michael S; He, Bing; Kranz, James K; Liu, Dingjiang; Narasimhan, Chakravarthy; Routhier, Eric; Taylor, Katherine D; Truong, Nobel; Stokes, Elaine S E

    2018-02-01

    The Biophorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of best practices for the development of biopharmaceuticals. To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Point Share group conducted an intercompany collaboration exercise, which included a bench-marking survey and extensive group discussions around the scope, design, and execution of robustness studies. The results of this industry collaboration revealed several key common themes: (1) overall DP robustness is defined by both the formulation and the manufacturing process robustness; (2) robustness integrates the principles of quality by design (QbD); (3) DP robustness is an important factor in setting critical quality attribute control strategies and commercial specifications; (4) most companies employ robustness studies, along with prior knowledge, risk assessments, and statistics, to develop the DP design space; (5) studies are tailored to commercial development needs and the practices of each company. Three case studies further illustrate how a robustness study design for a biopharmaceutical DP balances experimental complexity, statistical power, scientific understanding, and risk assessment to provide the desired product and process knowledge. The BPDG-Formulation Point Share discusses identified industry challenges with regard to biopharmaceutical DP robustness and presents some recommendations for best practices. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  15. Chemically defined media modifications to lower tryptophan oxidation of biopharmaceuticals.

    Science.gov (United States)

    Hazeltine, Laurie B; Knueven, Kristine M; Zhang, Yan; Lian, Zhirui; Olson, Donald J; Ouyang, Anli

    2016-01-01

    Oxidation of biopharmaceuticals is a major product quality issue with potential impacts on activity and immunogenicity. At Eli Lilly and Company, high tryptophan oxidation was observed for two biopharmaceuticals in development produced in Chinese hamster ovary cells. A switch from historical hydrolysate-containing media to chemically defined media with a reformulated basal powder was thought to be responsible, so mitigation efforts focused on media modification. Shake flask studies identified that increasing tryptophan, copper, and manganese and decreasing cysteine concentrations were individual approaches to lower tryptophan oxidation. When amino acid and metal changes were combined, the modified formulation had a synergistic impact that led to substantially less tryptophan oxidation for both biopharmaceuticals. Similar results were achieved in shake flasks and benchtop bioreactors, demonstrating the potential to implement these modifications at manufacturing scale. The modified formulation did not negatively impact cell growth and viability, product titer, purity, charge variants, or glycan profile. A potential mechanism of action is presented for each amino acid or metal factor based on its role in oxidation chemistry. This work served not only to mitigate the tryptophan oxidation issue in two Lilly biopharmaceuticals in development, but also to increase our knowledge and appreciation for the impact of media components on product quality. © 2015 American Institute of Chemical Engineers.

  16. The successes and challenges of open-source biopharmaceutical innovation.

    Science.gov (United States)

    Allarakhia, Minna

    2014-05-01

    Increasingly, open-source-based alliances seek to provide broad access to data, research-based tools, preclinical samples and downstream compounds. The challenge is how to create value from open-source biopharmaceutical innovation. This value creation may occur via transparency and usage of data across the biopharmaceutical value chain as stakeholders move dynamically between open source and open innovation. In this article, several examples are used to trace the evolution of biopharmaceutical open-source initiatives. The article specifically discusses the technological challenges associated with the integration and standardization of big data; the human capacity development challenges associated with skill development around big data usage; and the data-material access challenge associated with data and material access and usage rights, particularly as the boundary between open source and open innovation becomes more fluid. It is the author's opinion that the assessment of when and how value creation will occur, through open-source biopharmaceutical innovation, is paramount. The key is to determine the metrics of value creation and the necessary technological, educational and legal frameworks to support the downstream outcomes of now big data-based open-source initiatives. The continued focus on the early-stage value creation is not advisable. Instead, it would be more advisable to adopt an approach where stakeholders transform open-source initiatives into open-source discovery, crowdsourcing and open product development partnerships on the same platform.

  17. System diagnostics using qualitative analysis and component functional classification

    Science.gov (United States)

    Reifman, J.; Wei, T.Y.C.

    1993-11-23

    A method for detecting and identifying faulty component candidates during off-normal operations of nuclear power plants involves the qualitative analysis of macroscopic imbalances in the conservation equations of mass, energy and momentum in thermal-hydraulic control volumes associated with one or more plant components and the functional classification of components. The qualitative analysis of mass and energy is performed through the associated equations of state, while imbalances in momentum are obtained by tracking mass flow rates which are incorporated into a first knowledge base. The plant components are functionally classified, according to their type, as sources or sinks of mass, energy and momentum, depending upon which of the three balance equations is most strongly affected by a faulty component which is incorporated into a second knowledge base. Information describing the connections among the components of the system forms a third knowledge base. The method is particularly adapted for use in a diagnostic expert system to detect and identify faulty component candidates in the presence of component failures and is not limited to use in a nuclear power plant, but may be used with virtually any type of thermal-hydraulic operating system. 5 figures.

  18. System diagnostics using qualitative analysis and component functional classification

    International Nuclear Information System (INIS)

    Reifman, J.; Wei, T.Y.C.

    1993-01-01

    A method for detecting and identifying faulty component candidates during off-normal operations of nuclear power plants involves the qualitative analysis of macroscopic imbalances in the conservation equations of mass, energy and momentum in thermal-hydraulic control volumes associated with one or more plant components and the functional classification of components. The qualitative analysis of mass and energy is performed through the associated equations of state, while imbalances in momentum are obtained by tracking mass flow rates which are incorporated into a first knowledge base. The plant components are functionally classified, according to their type, as sources or sinks of mass, energy and momentum, depending upon which of the three balance equations is most strongly affected by a faulty component which is incorporated into a second knowledge base. Information describing the connections among the components of the system forms a third knowledge base. The method is particularly adapted for use in a diagnostic expert system to detect and identify faulty component candidates in the presence of component failures and is not limited to use in a nuclear power plant, but may be used with virtually any type of thermal-hydraulic operating system. 5 figures

  19. License Compliance Issues For Biopharmaceuticals: Special Challenges For Negotiations Between Companies And Non-Profit Research Institutions.

    Science.gov (United States)

    Ponzio, Todd A; Feindt, Hans; Ferguson, Steven

    2011-09-01

    the licensee's diligence and progress; most exclusive licenses include a commercial development plan, with penalties, financial or even revocation of the license, if the plan is not followed, e.g., the license falls too far behind.This study examines whether developmental milestone schedules based on a small molecule drug development model are useful and realistic in setting expectations for biopharmaceutical product development. We reviewed the monitoring records of all exclusive Public Health Service (PHS) commercial development license agreements for small molecule drugs or therapeutics based on biotechnology (biopharmaceuticals) executed by the National Institutes of Health (NIH) Office of Technology Transfer (OTT) between 2003 and 2009. We found that most biopharmaceutical development license agreements required amending because developmental milestones in the negotiated schedule could not be met by the licensee. This was in stark contrast with license agreements for small molecule chemical compounds which rarely needed changes to their developmental milestone schedules. As commercial development licenses for biopharmaceuticals make up the vast majority of NIH's exclusive license agreements, there is clearly a need to: 1) more closely examine how these benchmark schedules are formed, 2) try to understand the particular risk factors contributing to benchmark schedule non-compliance, and 3) devise alternatives to the current license benchmark schedule structural model. Schedules that properly weigh the most relevant risk factors such as technology classification (e.g., vaccine vs recombinant antibody vs gene therapy), likelihood of unforeseen regulatory issues, and company size/structure may help assure compliance with original license benchmark schedules. This understanding, coupled with a modified approach to the license negotiation process that makes use of a clear and comprehensive term sheet to minimize ambiguities should result in a more realistic benchmark

  20. Superiority of Classification Tree versus Cluster, Fuzzy and Discriminant Models in a Heartbeat Classification System.

    Directory of Open Access Journals (Sweden)

    Vessela Krasteva

    Full Text Available This study presents a 2-stage heartbeat classifier of supraventricular (SVB and ventricular (VB beats. Stage 1 makes computationally-efficient classification of SVB-beats, using simple correlation threshold criterion for finding close match with a predominant normal (reference beat template. The non-matched beats are next subjected to measurement of 20 basic features, tracking the beat and reference template morphology and RR-variability for subsequent refined classification in SVB or VB-class by Stage 2. Four linear classifiers are compared: cluster, fuzzy, linear discriminant analysis (LDA and classification tree (CT, all subjected to iterative training for selection of the optimal feature space among extended 210-sized set, embodying interactive second-order effects between 20 independent features. The optimization process minimizes at equal weight the false positives in SVB-class and false negatives in VB-class. The training with European ST-T, AHA, MIT-BIH Supraventricular Arrhythmia databases found the best performance settings of all classification models: Cluster (30 features, Fuzzy (72 features, LDA (142 coefficients, CT (221 decision nodes with top-3 best scored features: normalized current RR-interval, higher/lower frequency content ratio, beat-to-template correlation. Unbiased test-validation with MIT-BIH Arrhythmia database rates the classifiers in descending order of their specificity for SVB-class: CT (99.9%, LDA (99.6%, Cluster (99.5%, Fuzzy (99.4%; sensitivity for ventricular ectopic beats as part from VB-class (commonly reported in published beat-classification studies: CT (96.7%, Fuzzy (94.4%, LDA (94.2%, Cluster (92.4%; positive predictivity: CT (99.2%, Cluster (93.6%, LDA (93.0%, Fuzzy (92.4%. CT has superior accuracy by 0.3-6.8% points, with the advantage for easy model complexity configuration by pruning the tree consisted of easy interpretable 'if-then' rules.

  1. Superiority of Classification Tree versus Cluster, Fuzzy and Discriminant Models in a Heartbeat Classification System.

    Science.gov (United States)

    Krasteva, Vessela; Jekova, Irena; Leber, Remo; Schmid, Ramun; Abächerli, Roger

    2015-01-01

    This study presents a 2-stage heartbeat classifier of supraventricular (SVB) and ventricular (VB) beats. Stage 1 makes computationally-efficient classification of SVB-beats, using simple correlation threshold criterion for finding close match with a predominant normal (reference) beat template. The non-matched beats are next subjected to measurement of 20 basic features, tracking the beat and reference template morphology and RR-variability for subsequent refined classification in SVB or VB-class by Stage 2. Four linear classifiers are compared: cluster, fuzzy, linear discriminant analysis (LDA) and classification tree (CT), all subjected to iterative training for selection of the optimal feature space among extended 210-sized set, embodying interactive second-order effects between 20 independent features. The optimization process minimizes at equal weight the false positives in SVB-class and false negatives in VB-class. The training with European ST-T, AHA, MIT-BIH Supraventricular Arrhythmia databases found the best performance settings of all classification models: Cluster (30 features), Fuzzy (72 features), LDA (142 coefficients), CT (221 decision nodes) with top-3 best scored features: normalized current RR-interval, higher/lower frequency content ratio, beat-to-template correlation. Unbiased test-validation with MIT-BIH Arrhythmia database rates the classifiers in descending order of their specificity for SVB-class: CT (99.9%), LDA (99.6%), Cluster (99.5%), Fuzzy (99.4%); sensitivity for ventricular ectopic beats as part from VB-class (commonly reported in published beat-classification studies): CT (96.7%), Fuzzy (94.4%), LDA (94.2%), Cluster (92.4%); positive predictivity: CT (99.2%), Cluster (93.6%), LDA (93.0%), Fuzzy (92.4%). CT has superior accuracy by 0.3-6.8% points, with the advantage for easy model complexity configuration by pruning the tree consisted of easy interpretable 'if-then' rules.

  2. A new methodology for constructing a publication-level classification system of science

    OpenAIRE

    Waltman, Ludo; van Eck, Nees Jan

    2012-01-01

    Classifying journals or publications into research areas is an essential element of many bibliometric analyses. Classification usually takes place at the level of journals, where the Web of Science subject categories are the most popular classification system. However, journal-level classification systems have two important limitations: They offer only a limited amount of detail, and they have difficulties with multidisciplinary journals. To avoid these limitations, we introduce a new methodo...

  3. A Library Book Intelligence Classification System based on Multi-agent

    Science.gov (United States)

    Pengfei, Guo; Liangxian, Du; Junxia, Qi

    This paper introduces the concept of artificial intelligence into the administrative system of the library, and then gives the model of robot system in book classification based on multi-agent. The intelligent robot can recognize books' barcode automatically and here gives the classification algorithm according to the book classification of Chinese library. The algorithm can calculate the concrete position of the books, and relate with all similar books, thus the robot can put all congener books once without turning back.

  4. Update of the LIPID MAPS comprehensive classification system for lipids1

    OpenAIRE

    Fahy, Eoin; Subramaniam, Shankar; Murphy, Robert C.; Nishijima, Masahiro; Raetz, Christian R. H.; Shimizu, Takao; Spener, Friedrich; van Meer, Gerrit; Wakelam, Michael J. O.; Dennis, Edward A.

    2009-01-01

    In 2005, the International Lipid Classification and Nomenclature Committee under the sponsorship of the LIPID MAPS Consortium developed and established a “Comprehensive Classification System for Lipids” based on well-defined chemical and biochemical principles and using an ontology that is extensible, flexible, and scalable. This classification system, which is compatible with contemporary databasing and informatics needs, has now been accepted internationally and widely adopted. In response ...

  5. The classification of glomerulonephritis in systemic lupus erythematosus revisited

    NARCIS (Netherlands)

    Weening, Jan J.; D'Agati, Vivette D.; Schwartz, Melvin M.; Seshan, Surya V.; Alpers, Charles E.; Appel, Gerald B.; Balow, James E.; Bruijn, Jan A.; Cook, Terence; Ferrario, Franco; Fogo, Agnes B.; Ginzler, Ellen M.; Hebert, Lee; Hill, Gary; Hill, Prue; Jennette, J. Charles; Kong, Norella C.; Lesavre, Philippe; Lockshin, Michael; Looi, Lai-Meng; Makino, Hirofumi; Moura, Luiz A.; Nagata, Michio

    2004-01-01

    The currently used classification reflects our understanding of the pathogenesis of the various forms of lupus nephritis, but clinicopathologic studies have revealed the need for improved categorization and terminology. Based on the 1982 classification published under the auspices of the World

  6. Asynchronous data-driven classification of weapon systems

    International Nuclear Information System (INIS)

    Jin, Xin; Mukherjee, Kushal; Gupta, Shalabh; Ray, Asok; Phoha, Shashi; Damarla, Thyagaraju

    2009-01-01

    This communication addresses real-time weapon classification by analysis of asynchronous acoustic data, collected from microphones on a sensor network. The weapon classification algorithm consists of two parts: (i) feature extraction from time-series data using symbolic dynamic filtering (SDF), and (ii) pattern classification based on the extracted features using the language measure (LM) and support vector machine (SVM). The proposed algorithm has been tested on field data, generated by firing of two types of rifles. The results of analysis demonstrate high accuracy and fast execution of the pattern classification algorithm with low memory requirements. Potential applications include simultaneous shooter localization and weapon classification with soldier-wearable networked sensors. (rapid communication)

  7. An overview of some historical knowledge organisation systems and classifications with a special emphasy on monastery libraries’ classification

    Directory of Open Access Journals (Sweden)

    Sonja Svoljšak

    2005-01-01

    Full Text Available The article gives an overview of some most prominent historical turning – points in the field of knowledge organization an2d western European sistematization of science, based on Greek and christian philosophy. Some examples of earlier attempts to unify the systems of knowledge organization and science systematization are presented. Some specific systems of the most prominent European christian religious orders’ library contents arrangement and classification are described in this context.

  8. IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes.

    Science.gov (United States)

    Darwich, Adam S; Margolskee, Alison; Pepin, Xavier; Aarons, Leon; Galetin, Aleksandra; Rostami-Hodjegan, Amin; Carlert, Sara; Hammarberg, Maria; Hilgendorf, Constanze; Johansson, Pernilla; Karlsson, Eva; Murphy, Dónal; Tannergren, Christer; Thörn, Helena; Yasin, Mohammed; Mazuir, Florent; Nicolas, Olivier; Ramusovic, Sergej; Xu, Christine; Pathak, Shriram M; Korjamo, Timo; Laru, Johanna; Malkki, Jussi; Pappinen, Sari; Tuunainen, Johanna; Dressman, Jennifer; Hansmann, Simone; Kostewicz, Edmund; He, Handan; Heimbach, Tycho; Wu, Fan; Hoft, Carolin; Pang, Yan; Bolger, Michael B; Huehn, Eva; Lukacova, Viera; Mullin, James M; Szeto, Ke X; Costales, Chester; Lin, Jian; McAllister, Mark; Modi, Sweta; Rotter, Charles; Varma, Manthena; Wong, Mei; Mitra, Amitava; Bevernage, Jan; Biewenga, Jeike; Van Peer, Achiel; Lloyd, Richard; Shardlow, Carole; Langguth, Peter; Mishenzon, Irina; Nguyen, Mai Anh; Brown, Jonathan; Lennernäs, Hans; Abrahamsson, Bertil

    2017-01-01

    Three Physiologically Based Pharmacokinetic software packages (GI-Sim, Simcyp® Simulator, and GastroPlus™) were evaluated as part of the Innovative Medicine Initiative Oral Biopharmaceutics Tools project (OrBiTo) during a blinded "bottom-up" anticipation of human pharmacokinetics. After data analysis of the predicted vs. measured pharmacokinetics parameters, it was found that oral bioavailability (F oral ) was underpredicted for compounds with low permeability, suggesting improper estimates of intestinal surface area, colonic absorption and/or lack of intestinal transporter information. F oral was also underpredicted for acidic compounds, suggesting overestimation of impact of ionisation on permeation, lack of information on intestinal transporters, or underestimation of solubilisation of weak acids due to less than optimal intestinal model pH settings or underestimation of bile micelle contribution. F oral was overpredicted for weak bases, suggesting inadequate models for precipitation or lack of in vitro precipitation information to build informed models. Relative bioavailability was underpredicted for both high logP compounds as well as poorly water-soluble compounds, suggesting inadequate models for solubility/dissolution, underperforming bile enhancement models and/or lack of biorelevant solubility measurements. These results indicate areas for improvement in model software, modelling approaches, and generation of applicable input data. However, caution is required when interpreting the impact of drug-specific properties in this exercise, as the availability of input parameters was heterogeneous and highly variable, and the modellers generally used the data "as is" in this blinded bottom-up prediction approach. Copyright © 2016 Elsevier B.V. All rights reserved.

  9. Classification of toddler nutritional status using fuzzy inference system (FIS)

    Science.gov (United States)

    Permatasari, Dian; Azizah, Isnaini Nur; Hadiat, Hanifah Latifah; Abadi, Agus Maman

    2017-08-01

    Nutrition is a major health problem and concern for parents when it is relating with their toddler. The nutritional status is an expression of the state caused by the status of the balance between the number of intake of nutrients and the amount needed by the body for a variety of biological functions. The indicators that often used to determine the nutritional status is the combination of Weight (W) and Height (H) symbolized by W/H, because it describe a sensitive and specific nutritional status. This study aims to apply the Fuzzy Inference System Mamdani method to classify the nutritional status of toddler. The inputs are weight and height of the toddler. There are nine rules that used and the output is nutritional status classification consisting of four criteria: stunting, wasting, normal, and overweight. Fuzzy Inference System that be used is Mamdani method and the defuzzification use Centroid Method. The result of this study is compared with Assessment Anthropometric Standard of Toddler Nutritional Status by Ministry of Health. The accuracy level of this fuzzy model is about 84%.

  10. Drug-induced sedation endoscopy (DISE) classification systems: a systematic review and meta-analysis.

    Science.gov (United States)

    Dijemeni, Esuabom; D'Amone, Gabriele; Gbati, Israel

    2017-12-01

    Drug-induced sedation endoscopy (DISE) classification systems have been used to assess anatomical findings on upper airway obstruction, and decide and plan surgical treatments and act as a predictor for surgical treatment outcome for obstructive sleep apnoea management. The first objective is to identify if there is a universally accepted DISE grading and classification system for analysing DISE findings. The second objective is to identify if there is one DISE grading and classification treatment planning framework for deciding appropriate surgical treatment for obstructive sleep apnoea (OSA). The third objective is to identify if there is one DISE grading and classification treatment outcome framework for determining the likelihood of success for a given OSA surgical intervention. A systematic review was performed to identify new and significantly modified DISE classification systems: concept, advantages and disadvantages. Fourteen studies proposing a new DISE classification system and three studies proposing a significantly modified DISE classification were identified. None of the studies were based on randomised control trials. DISE is an objective method for visualising upper airway obstruction. The classification and assessment of clinical findings based on DISE is highly subjective due to the increasing number of DISE classification systems. Hence, this creates a growing divergence in surgical treatment planning and treatment outcome. Further research on a universally accepted objective DISE assessment is critically needed.

  11. Perceptual and Acoustic Reliability Estimates for the Speech Disorders Classification System (SDCS)

    Science.gov (United States)

    Shriberg, Lawrence D.; Fourakis, Marios; Hall, Sheryl D.; Karlsson, Heather B.; Lohmeier, Heather L.; McSweeny, Jane L.; Potter, Nancy L.; Scheer-Cohen, Alison R.; Strand, Edythe A.; Tilkens, Christie M.; Wilson, David L.

    2010-01-01

    A companion paper describes three extensions to a classification system for paediatric speech sound disorders termed the Speech Disorders Classification System (SDCS). The SDCS uses perceptual and acoustic data reduction methods to obtain information on a speaker's speech, prosody, and voice. The present paper provides reliability estimates for…

  12. Volunteer-Based System for classification of traffic in computer networks

    DEFF Research Database (Denmark)

    Bujlow, Tomasz; Balachandran, Kartheepan; Riaz, M. Tahir

    2011-01-01

    To overcome the drawbacks of existing methods for traffic classification (by ports, Deep Packet Inspection, statistical classification) a new system was developed, in which the data are collected from client machines. This paper presents design of the system, implementation, initial runs...

  13. Application of the Safety Classification of Structures, Systems and Components in Nuclear Power Plants

    International Nuclear Information System (INIS)

    2016-04-01

    This publication describes how to complete tasks associated with every step of the classification methodology set out in IAEA Safety Standards Series No. SSG-30, Safety Classification of Structures, Systems and Components in Nuclear Power Plants. In particular, how to capture all the structures, systems and components (SSCs) of a nuclear power plant to be safety classified. Emphasis is placed on the SSCs that are necessary to limit radiological releases to the public and occupational doses to workers in operational conditions This publication provides information for organizations establishing a comprehensive safety classification of SSCs compliant with IAEA recommendations, and to support regulators in reviewing safety classification submitted by licensees

  14. Intelligence system based classification approach for medical disease diagnosis

    Science.gov (United States)

    Sagir, Abdu Masanawa; Sathasivam, Saratha

    2017-08-01

    The prediction of breast cancer in women who have no signs or symptoms of the disease as well as survivability after undergone certain surgery has been a challenging problem for medical researchers. The decision about presence or absence of diseases depends on the physician's intuition, experience and skill for comparing current indicators with previous one than on knowledge rich data hidden in a database. This measure is a very crucial and challenging task. The goal is to predict patient condition by using an adaptive neuro fuzzy inference system (ANFIS) pre-processed by grid partitioning. To achieve an accurate diagnosis at this complex stage of symptom analysis, the physician may need efficient diagnosis system. A framework describes methodology for designing and evaluation of classification performances of two discrete ANFIS systems of hybrid learning algorithms least square estimates with Modified Levenberg-Marquardt and Gradient descent algorithms that can be used by physicians to accelerate diagnosis process. The proposed method's performance was evaluated based on training and test datasets with mammographic mass and Haberman's survival Datasets obtained from benchmarked datasets of University of California at Irvine's (UCI) machine learning repository. The robustness of the performance measuring total accuracy, sensitivity and specificity is examined. In comparison, the proposed method achieves superior performance when compared to conventional ANFIS based gradient descent algorithm and some related existing methods. The software used for the implementation is MATLAB R2014a (version 8.3) and executed in PC Intel Pentium IV E7400 processor with 2.80 GHz speed and 2.0 GB of RAM.

  15. Classification System for Individualized Treatment of Adult Buried Penis Syndrome.

    Science.gov (United States)

    Tausch, Timothy J; Tachibana, Isamu; Siegel, Jordan A; Hoxworth, Ronald; Scott, Jeremy M; Morey, Allen F

    2016-09-01

    The authors present their experience with reconstructive strategies for men with various manifestations of adult buried penis syndrome, and propose a comprehensive anatomical classification system and treatment algorithm based on pathologic changes in the penile skin and involvement of neighboring abdominal and/or scrotal components. The authors reviewed all patients who underwent reconstruction of adult buried penis syndrome at their referral center between 2007 and 2015. Patients were stratified by location and severity of involved anatomical components. Procedures performed, demographics, comorbidities, and clinical outcomes were reviewed. Fifty-six patients underwent reconstruction of buried penis at the authors' center from 2007 to 2015. All procedures began with a ventral penile release. If the uncovered penile skin was determined to be viable, a phalloplasty was performed by anchoring penoscrotal skin to the proximal shaft, and the ventral shaft skin defect was closed with scrotal flaps. In more complex patients with circumferential nonviable penile skin, the penile skin was completely excised and replaced with a split-thickness skin graft. Complex patients with severe abdominal lipodystrophy required adjacent tissue transfer. For cases of genital lymphedema, the procedure involved complete excision of the lymphedematous tissue, and primary closure with or without a split-thickness skin graft, also often involving the scrotum. The authors' overall success rate was 88 percent (49 of 56), defined as resolution of symptoms without the need for additional procedures. Successful correction of adult buried penis often necessitates an interdisciplinary, multimodal approach. Therapeutic, IV.

  16. A novel classification system for evolutionary aging theories.

    Science.gov (United States)

    Trindade, Lucas S; Aigaki, Toshiro; Peixoto, Alexandre A; Balduino, Alex; Mânica da Cruz, Ivana B; Heddle, Jonathan G

    2013-01-01

    Theories of lifespan evolution are a source of confusion amongst aging researchers. After a century of aging research the dispute over whether the aging process is active or passive persists and a comprehensive and universally accepted theoretical model remains elusive. Evolutionary aging theories primarily dispute whether the aging process is exclusively adapted to favor the kin or exclusively non-adapted to favor the individual. Interestingly, contradictory data and theories supporting both exclusively programmed and exclusively non-programmed theories continue to grow. However, this is a false dichotomy; natural selection favors traits resulting in efficient reproduction whether they benefit the individual or the kin. Thus, to understand the evolution of aging, first we must understand the environment-dependent balance between the advantages and disadvantages of extended lifespan in the process of spreading genes. As described by distinct theories, different niches and environmental conditions confer on extended lifespan a range of fitness values varying from highly beneficial to highly detrimental. Here, we considered the range of fitness values for extended lifespan and develop a fitness-based framework for categorizing existing theories. We show that all theories can be classified into four basic types: secondary (beneficial), maladaptive (neutral), assisted death (detrimental), and senemorphic aging (varying between beneficial to detrimental). We anticipate that this classification system will assist with understanding and interpreting aging/death by providing a way of considering theories as members of one of these classes rather than consideration of their individual details.

  17. Intra- and interrater reliability of three different MRI grading and classification systems after acute hamstring injuries.

    Science.gov (United States)

    Wangensteen, Arnlaug; Tol, Johannes L; Roemer, Frank W; Bahr, Roald; Dijkstra, H Paul; Crema, Michel D; Farooq, Abdulaziz; Guermazi, Ali

    2017-04-01

    To assess and compare the intra- and interrater reliability of three different MRI grading and classification systems after acute hamstring injury. Male athletes (n=40) with clinical diagnosis of acute hamstring injury and MRI ≤5days were selected from a prospective cohort. Two radiologists independently evaluated the MRIs using standardised scoring form including the modified Peetrons grading system, the Chan acute muscle strain injury classification and the British Athletics Muscle Injury Classification. Intra-and interrater reliability was assessed with linear weighted kappa (κ) or unweighted Cohen's κ and percentage agreement was calculated. We observed 'substantial' to 'almost perfect' intra- (κ range 0.65-1.00) and interrater reliability (κ range 0.77-1.00) with percentage agreement 83-100% and 88-100%, respectively, for severity gradings, overall anatomical sites and overall classifications for the three MRI systems. We observed substantial variability (κ range -0.05 to 1.00) for subcategories within the Chan classification and the British Athletics Muscle Injury Classification, however, the prevalence of positive scorings was low for some subcategories. The modified Peetrons grading system, overall Chan classification and overall British Athletics Muscle Injury Classification demonstrated 'substantial' to 'almost perfect' intra- and interrater reliability when scored by experienced radiologists. The intra- and interrater reliability for the anatomical subcategories within the classifications remains unclear. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Toward a common classification approach for biorefinery systems

    NARCIS (Netherlands)

    Cherubini, F.; Jungmeier, G.; Wellisch, M.; Wilke, T.; Skiadas, I.; Ree, van R.; Jong, de E.

    2009-01-01

    This paper deals with a biorefinery classification approach developed within International Energy Agency (IEA) Bioenergy Task 42. Since production of transportation biofuels is seen as the driving force for future biorefinery developments, a selection of the most interesting transportation biofuels

  19. Mining vehicle classifications from the Columbus Metropolitan Freeway Management System.

    Science.gov (United States)

    2015-01-01

    Vehicle classification data are used in many transportation applications, including: pavement design, : environmental impact studies, traffic control, and traffic safety. Ohio has over 200 permanent count stations, : supplemented by many more short-t...

  20. Lie Group Classification of a Generalized Lane-Emden Type System in Two Dimensions

    Directory of Open Access Journals (Sweden)

    Motlatsi Molati

    2012-01-01

    Full Text Available The aim of this work is to perform a complete Lie symmetry classification of a generalized Lane-Emden type system in two dimensions which models many physical phenomena in biological and physical sciences. The classical approach of group classification is employed for classification. We show that several cases arise in classifying the arbitrary parameters, the forms of which include amongst others the power law nonlinearity, and exponential and quadratic forms.

  1. Intra- and interrater reliability of three different MRI grading and classification systems after acute hamstring injuries

    International Nuclear Information System (INIS)

    Wangensteen, Arnlaug; Tol, Johannes L.; Roemer, Frank W.; Bahr, Roald; Dijkstra, H. Paul; Crema, Michel D.; Farooq, Abdulaziz; Guermazi, Ali

    2017-01-01

    Highlights: • Three different MRI grading and classification systems for acute hamstring injuries are overall reliable. • Reliability for the subcategories within these MRI grading and classification systems remains, however, unclear. - Abstract: Objective: To assess and compare the intra- and interrater reliability of three different MRI grading and classification systems after acute hamstring injury. Methods: Male athletes (n = 40) with clinical diagnosis of acute hamstring injury and MRI ≤5 days were selected from a prospective cohort. Two radiologists independently evaluated the MRIs using standardised scoring form including the modified Peetrons grading system, the Chan acute muscle strain injury classification and the British Athletics Muscle Injury Classification. Intra-and interrater reliability was assessed with linear weighted kappa (κ) or unweighted Cohen's κ and percentage agreement was calculated. Results: We observed ‘substantial’ to ‘almost perfect’ intra- (κ range 0.65–1.00) and interrater reliability (κ range 0.77–1.00) with percentage agreement 83–100% and 88–100%, respectively, for severity gradings, overall anatomical sites and overall classifications for the three MRI systems. We observed substantial variability (κ range −0.05 to 1.00) for subcategories within the Chan classification and the British Athletics Muscle Injury Classification, however, the prevalence of positive scorings was low for some subcategories. Conclusions: The modified Peetrons grading system, overall Chan classification and overall British Athletics Muscle Injury Classification demonstrated ‘substantial' to ‘almost perfect' intra- and interrater reliability when scored by experienced radiologists. The intra- and interrater reliability for the anatomical subcategories within the classifications remains unclear.

  2. Intra- and interrater reliability of three different MRI grading and classification systems after acute hamstring injuries

    Energy Technology Data Exchange (ETDEWEB)

    Wangensteen, Arnlaug, E-mail: arnlaug.wangensteen@nih.no [Aspetar, Orthopaedic and Sports Medicine Hospital, Doha (Qatar); Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo (Norway); Tol, Johannes L., E-mail: johannes.tol@aspetar.com [Aspetar, Orthopaedic and Sports Medicine Hospital, Doha (Qatar); Amsterdam Center for Evidence Sports Medicine, Academic Medical Center (Netherlands); The Sports Physician Group, OLVG, Amsterdam (Netherlands); Roemer, Frank W. [Quantitative Imaging Center, Department of Radiology, Boston University School of Medicine, Boston, MA (United States); Department of Radiology, University of Erlangen-Nuremberg, Erlangen (Germany); Bahr, Roald [Aspetar, Orthopaedic and Sports Medicine Hospital, Doha (Qatar); Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo (Norway); Dijkstra, H. Paul [Aspetar, Orthopaedic and Sports Medicine Hospital, Doha (Qatar); Crema, Michel D. [Quantitative Imaging Center, Department of Radiology, Boston University School of Medicine, Boston, MA (United States); Department of Radiology, Saint-Antoine Hospital, University Paris VI, Paris (France); Farooq, Abdulaziz [Aspetar, Orthopaedic and Sports Medicine Hospital, Doha (Qatar); Guermazi, Ali [Quantitative Imaging Center, Department of Radiology, Boston University School of Medicine, Boston, MA (United States)

    2017-04-15

    Highlights: • Three different MRI grading and classification systems for acute hamstring injuries are overall reliable. • Reliability for the subcategories within these MRI grading and classification systems remains, however, unclear. - Abstract: Objective: To assess and compare the intra- and interrater reliability of three different MRI grading and classification systems after acute hamstring injury. Methods: Male athletes (n = 40) with clinical diagnosis of acute hamstring injury and MRI ≤5 days were selected from a prospective cohort. Two radiologists independently evaluated the MRIs using standardised scoring form including the modified Peetrons grading system, the Chan acute muscle strain injury classification and the British Athletics Muscle Injury Classification. Intra-and interrater reliability was assessed with linear weighted kappa (κ) or unweighted Cohen's κ and percentage agreement was calculated. Results: We observed ‘substantial’ to ‘almost perfect’ intra- (κ range 0.65–1.00) and interrater reliability (κ range 0.77–1.00) with percentage agreement 83–100% and 88–100%, respectively, for severity gradings, overall anatomical sites and overall classifications for the three MRI systems. We observed substantial variability (κ range −0.05 to 1.00) for subcategories within the Chan classification and the British Athletics Muscle Injury Classification, however, the prevalence of positive scorings was low for some subcategories. Conclusions: The modified Peetrons grading system, overall Chan classification and overall British Athletics Muscle Injury Classification demonstrated ‘substantial' to ‘almost perfect' intra- and interrater reliability when scored by experienced radiologists. The intra- and interrater reliability for the anatomical subcategories within the classifications remains unclear.

  3. Update of the LIPID MAPS comprehensive classification system for lipids1

    Science.gov (United States)

    Fahy, Eoin; Subramaniam, Shankar; Murphy, Robert C.; Nishijima, Masahiro; Raetz, Christian R. H.; Shimizu, Takao; Spener, Friedrich; van Meer, Gerrit; Wakelam, Michael J. O.; Dennis, Edward A.

    2009-01-01

    In 2005, the International Lipid Classification and Nomenclature Committee under the sponsorship of the LIPID MAPS Consortium developed and established a “Comprehensive Classification System for Lipids” based on well-defined chemical and biochemical principles and using an ontology that is extensible, flexible, and scalable. This classification system, which is compatible with contemporary databasing and informatics needs, has now been accepted internationally and widely adopted. In response to considerable attention and requests from lipid researchers from around the globe and in a variety of fields, the comprehensive classification system has undergone significant revisions over the last few years to more fully represent lipid structures from a wider variety of sources and to provide additional levels of detail as necessary. The details of this classification system are reviewed and updated and are presented here, along with revisions to its suggested nomenclature and structure-drawing recommendations for lipids. PMID:19098281

  4. Transporter Classification Database (TCDB)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Transporter Classification Database details a comprehensive classification system for membrane transport proteins known as the Transporter Classification (TC)...

  5. Oro-facial pain and temporomandibular disorders classification systems: A critical appraisal and future directions.

    Science.gov (United States)

    Klasser, G D; Manfredini, D; Goulet, J-P; De Laat, A

    2018-03-01

    It is a difficult undertaking to design a classification system for any disease entity, let alone for oro-facial pain (OFP) and more specifically for temporomandibular disorders (TMD). A further complication of this task is that both physical and psychosocial variables must be included. To augment this process, a two-step systematic review, adhering to PRISMA guidelines, of the classification systems published during the last 20 years for OFP and TMD was performed. The first search step identified 190 potential citations which ultimately resulted in only 17 articles being included for in-depth analysis and review. The second step resulted in only 5 articles being selected for inclusion in this review. Five additional articles and four classification guidelines/criteria were also included due to expansion of the search criteria. Thus, in total, 14 documents comprising articles and guidelines/criteria (8 proposals of classification systems for OFP; 6 for TMD) were selected for inclusion in the systematic review. For each, a discussion as to their advantages, strengths and limitations was provided. Suggestions regarding the future direction for improving the classification process with the use of ontological principles rather than taxonomy are discussed. Furthermore, the potential for expanding the scope of axes included in existing classification systems, to include genetic, epigenetic and neurobiological variables, is explored. It is therefore recommended that future classification system proposals be based on combined approaches aiming to provide archetypal treatment-oriented classifications. © 2017 John Wiley & Sons Ltd.

  6. Heartbeat classification system based on neural networks and dimensionality reduction

    Directory of Open Access Journals (Sweden)

    Rodolfo de Figueiredo Dalvi

    Full Text Available Abstract Introduction This paper presents a complete approach for the automatic classification of heartbeats to assist experts in the diagnosis of typical arrhythmias, such as right bundle branch block, left bundle branch block, premature ventricular beats, premature atrial beats and paced beats. Methods A pre-processing step was performed on the electrocardiograms (ECG for baseline removal. Next, a QRS complex detection algorithm was implemented to detect the heartbeats, which contain the primary information that is employed in the classification approach. Next, ECG segmentation was performed, by which a set of features based on the RR interval and the beat waveform morphology were extracted from the ECG signal. The size of the feature vector was reduced by principal component analysis. Finally, the reduced feature vector was employed as the input to an artificial neural network. Results Our approach was tested on the Massachusetts Institute of Technology arrhythmia database. The classification performance on a test set of 18 ECG records of 30 min each achieved an accuracy of 96.97%, a sensitivity of 95.05%, a specificity of 90.88%, a positive predictive value of 95.11%, and a negative predictive value of 92.7%. Conclusion The proposed approach achieved high accuracy for classifying ECG heartbeats and could be used to assist cardiologists in telecardiology services. The main contribution of our classification strategy is in the feature selection step, which reduced classification complexity without major changes in the performance.

  7. A Hybrid Classification System for Heart Disease Diagnosis Based on the RFRS Method

    Directory of Open Access Journals (Sweden)

    Xiao Liu

    2017-01-01

    Full Text Available Heart disease is one of the most common diseases in the world. The objective of this study is to aid the diagnosis of heart disease using a hybrid classification system based on the ReliefF and Rough Set (RFRS method. The proposed system contains two subsystems: the RFRS feature selection system and a classification system with an ensemble classifier. The first system includes three stages: (i data discretization, (ii feature extraction using the ReliefF algorithm, and (iii feature reduction using the heuristic Rough Set reduction algorithm that we developed. In the second system, an ensemble classifier is proposed based on the C4.5 classifier. The Statlog (Heart dataset, obtained from the UCI database, was used for experiments. A maximum classification accuracy of 92.59% was achieved according to a jackknife cross-validation scheme. The results demonstrate that the performance of the proposed system is superior to the performances of previously reported classification techniques.

  8. Review of Medical Image Classification using the Adaptive Neuro-Fuzzy Inference System.

    Science.gov (United States)

    Hosseini, Monireh Sheikh; Zekri, Maryam

    2012-01-01

    Image classification is an issue that utilizes image processing, pattern recognition and classification methods. Automatic medical image classification is a progressive area in image classification, and it is expected to be more developed in the future. Because of this fact, automatic diagnosis can assist pathologists by providing second opinions and reducing their workload. This paper reviews the application of the adaptive neuro-fuzzy inference system (ANFIS) as a classifier in medical image classification during the past 16 years. ANFIS is a fuzzy inference system (FIS) implemented in the framework of an adaptive fuzzy neural network. It combines the explicit knowledge representation of an FIS with the learning power of artificial neural networks. The objective of ANFIS is to integrate the best features of fuzzy systems and neural networks. A brief comparison with other classifiers, main advantages and drawbacks of this classifier are investigated.

  9. Improvements to the current classification of salary expenses in the accounting system of the enterprise

    Directory of Open Access Journals (Sweden)

    Fylypenko Anna

    2016-04-01

    Full Text Available The article considers the existing classification of salary expenses in Ukraine. The analysis of the classifications of such costs in management and accounting is carried out. The article suggests approaches for improvement in the cost-accounting system for the respective enterprise features, which greatly facilitates the management of salary expenses and allows the search of reserves to reduce them.

  10. An ecological classification system for the central hardwoods region: The Hoosier National Forest

    Science.gov (United States)

    James E. Van Kley; George R. Parker

    1993-01-01

    This study, a multifactor ecological classification system, using vegetation, soil characteristics, and physiography, was developed for the landscape of the Hoosier National Forest in Southern Indiana. Measurements of ground flora, saplings, and canopy trees from selected stands older than 80 years were subjected to TWINSPAN classification and DECORANA ordination....

  11. Inter-rater reliability of the EPUAP pressure ulcer classification system using photographs.

    NARCIS (Netherlands)

    Defloor, T.; Schoonhoven, L.

    2004-01-01

    BACKGROUND: Many classification systems for grading pressure ulcers are discussed in the literature. Correct identification and classification of a pressure ulcer is important for accurate reporting of the magnitude of the problem, and for timely prevention. The reliability of pressure ulcer

  12. STANSORT - Stanford Remote Sensing Laboratory pattern recognition and classification system

    Science.gov (United States)

    Honey, F. R.; Prelat, A.; Lyon, R. J. P.

    1974-01-01

    The principal barrier to routine use of the ERTS multispectral scanner computer compatible tapes, rather than photointerpretation examination of the images, has been the high computing costs involved due to the large quantity of information (4 Mbytes) contained in a scene. STANSORT, the interactive program package developed at Stanford Remote Sensing Laboratories alleviates this problem, providing an extremely rapid, flexible and low cost tool for data reduction, scene classification, species searches and edge detection. The primary classification procedure, utilizing a search with variable gate widths, for similarities in the normalized, digitized spectra is described along with associated procedures for data refinement and extraction of information. The more rigorous statistical classification procedures are also explained.

  13. Iterative Self Organized Data Algorithm for Fault Classification of Mechanical System

    OpenAIRE

    Jayamala K. Patil; P. B. Ghewari; S. S. Nagtilak

    2011-01-01

    The challenging issue for mechanical industry is to develop fast & reliable fault diagnosis systems before total breakdown of machine. Fault diagnosis & classification of faults of mechanical systems is a difficult task. It improves productivity & reduces cost of production. This paper presents an approach for classification of commonly observed faults in gears of mechanical system. These faults include weared gear, gear with one tooth broken & gear with crack on one tooth. The Power Spectral...

  14. Toward a common classification approach for biorefinery systems

    DEFF Research Database (Denmark)

    Cherubini, Francesco; Jungmeier, Gerfried; Wellisch, Maria

    2009-01-01

    until 2020 is based on their characteristics to be mixed with gasoline, diesel and natural gas, reflecting the main advantage of using the already-existing infrastructure for easier market introduction. This classification approach relies on four main features: (1) platforms; (2) products; (3) feedstock...

  15. An intelligent temporal pattern classification system using fuzzy ...

    Indian Academy of Sciences (India)

    Temporal fuzzy min–max (TFMM) neural network; particle swarm optimization algorithm (PSOA); pattern classification; rule extraction. 1. Introduction. Data mining is concerned with analysing large volumes of data to automatically discover interesting relationships which in turn lead to better understanding of the underlying ...

  16. Generating Clustered Journal Maps : An Automated System for Hierarchical Classification

    NARCIS (Netherlands)

    Leydesdorff, L.; Bornmann, L.; Wagner, C.S.

    2017-01-01

    Journal maps and classifications for 11,359 journals listed in the combined Journal Citation Reports 2015 of the Science and Social Sciences Citation Indexes are provided at https://leydesdorff.github.io/journals/ and http://www.leydesdorff.net/jcr15. A routine using VOSviewer for integrating the

  17. In Situ Intestinal Perfusion in Rodents: Future Perspectives for Application on Absorption Studies and Classification of Drugs.

    Science.gov (United States)

    Dezani, Thaisa Marinho; Dezani, Andre Bersani; de Silva, Monica Maria Coquemala; Dos Reis Serra, Cristina Helena

    2017-01-01

    In 1995, the Biopharmaceutics Classification System (BCS) was proposed by Amidon and colleagues as a tool that considers two important parameters regarding drugs: solubility and permeability. Since then, several methods for solubility and permeability studies have been developed for drug delivery and absorption prediction. In recent years, permeability has gained a great highlight and the interaction between a molecule and a biological membrane is not enough to predict the in vivo behavior of a compound. Thus, different methods for permeability assessment are currently used for mechanistic studies including involvement of carriers and several transport pathways. Furthermore, the investigation regarding metabolism has been a focus in recent researches. Based on this idea, Wu and Benet proposed a new tool called Biopharmaceutics Drug Disposition Classification System (BDDCS), where drugs are classified into four classes considering their solubility and metabolism. Among several methods for permeability studies, the in situ intestinal perfusion is considered the closest to in vivo conditions due advantages as intact blood supply and innervation. This review presents the in situ intestinal perfusion model and its application for permeability/ transport studies of drugs and intestinal metabolism. Also, this paper discusses about how the in situ perfusion studies can be used for classification of drugs and the future perspectives for in vivo absorption prediction. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  18. CLASSIFICATION OF SYSTEMS FOR PASSIVE AFTERHEAT REMOVAL FROM REACTOR CONTAINMENT OF NUCLEAR POWER PLANT WITH WATER-COOLED POWER REACTOR

    Directory of Open Access Journals (Sweden)

    N. Khaled

    2014-01-01

    Full Text Available A classification on systems for passive afterheat removal from reactor containment has been developed in the paper.  The classification permits to make a detailed analysis of various concepts pertaining to systems for passive afterheat removal from reactor containment of new generation. The paper considers main classification features of the given systems.

  19. Cause of and factors associated with stillbirth: a systematic review of classification systems.

    Science.gov (United States)

    Aminu, Mamuda; Bar-Zeev, Sarah; van den Broek, Nynke

    2017-05-01

    An estimated 2.6 million stillbirths occur worldwide each year. A standardized classification system setting out possible cause of death and contributing factors is useful to help obtain comparative data across different settings. We undertook a systematic review of stillbirth classification systems to highlight their strengths and weaknesses for practitioners and policymakers. We conducted a systematic search and review of the literature to identify the classification systems used to aggregate information for stillbirth and perinatal deaths. Narrative synthesis was used to compare the range and depth of information required to apply the systems, and the different categories provided for cause of and factors contributing to stillbirth. A total of 118 documents were screened; 31 classification systems were included, of which six were designed specifically for stillbirth, 14 for perinatal death, three systems included neonatal deaths and two included infant deaths. Most (27/31) were developed in and first tested using data obtained from high-income settings. All systems required information from clinical records. One-third of the classification systems (11/31) included information obtained from histology or autopsy. The percentage where cause of death remained unknown ranged from 0.39% using the Nordic-Baltic classification to 46.4% using the Keeling system. Over time, classification systems have become more complex. The success of application is dependent on the availability of detailed clinical information and laboratory investigations. Systems that adopt a layered approach allow for classification of cause of death to a broad as well as to a more detailed level. © 2017 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).

  20. A review on fault classification methodologies in power transmission systems: Part-II

    Directory of Open Access Journals (Sweden)

    Avagaddi Prasad

    2018-05-01

    Full Text Available The countless extent of power systems and applications requires the improvement in suitable techniques for the fault classification in power transmission systems, to increase the efficiency of the systems and to avoid major damages. For this purpose, the technical literature proposes a large number of methods. The paper analyzes the technical literature, summarizing the most important methods that can be applied to fault classification methodologies in power transmission systems.The part 2 of the article is named “A review on fault classification methodologies in power transmission systems”. In this part 2 we discussed the advanced technologies developed by various researchers for fault classification in power transmission systems. Keywords: Transmission line protection, Protective relaying, Soft computing techniques

  1. 關於圖書分類法的修訂 Concerning the Revision of Classification System

    Directory of Open Access Journals (Sweden)

    Ho-chin Chen

    1999-03-01

    Full Text Available 無For reviewing a classification scheme, we usually look in much detail at its traditional features such as detailed schedules, hospital notation, a supportive index and its adaptability. Yet another desirable feature, a good and financially secure revision programme, is a key point to the success of classification scheme. The author traces the history of revision processes of three successful classification systems (Dewey Decimal Classification, Library of Congress Classification and Universal Decimal Classification , and attempt to recommend the better revision mechanism for Lai's New Classification Scheme for Chinese Libraries ( 中國 圖書分類法in Taiwan

  2. Overview of Four Functional Classification Systems Commonly Used in Cerebral Palsy

    Directory of Open Access Journals (Sweden)

    Andrea Paulson

    2017-04-01

    Full Text Available Cerebral palsy (CP is the most common physical disability in childhood. CP comprises a heterogeneous group of disorders that can result in spasticity, dystonia, muscle contractures, weakness and coordination difficulty that ultimately affects the ability to control movements. Traditionally, CP has been classified using a combination of the motor type and the topographical distribution, as well as subjective severity level. Imprecise terms such as these tell very little about what a person is able to do functionally and can impair clear communication between providers. More recently, classification systems have been created employing a simple ordinal grading system of functional performance. These systems allow a more precise discussion between providers, as well as better subject stratification for research. The goal of this review is to describe four common functional classification systems for cerebral palsy: the Gross Motor Function Classification System (GMFCS, the Manual Ability Classification System (MACS, the Communication Function Classification System (CFCS, and the Eating and Drinking Ability Classification System (EDACS. These measures are all standardized, reliable, and complementary to one another.

  3. Overview of Four Functional Classification Systems Commonly Used in Cerebral Palsy.

    Science.gov (United States)

    Paulson, Andrea; Vargus-Adams, Jilda

    2017-04-24

    Cerebral palsy (CP) is the most common physical disability in childhood. CP comprises a heterogeneous group of disorders that can result in spasticity, dystonia, muscle contractures, weakness and coordination difficulty that ultimately affects the ability to control movements. Traditionally, CP has been classified using a combination of the motor type and the topographical distribution, as well as subjective severity level. Imprecise terms such as these tell very little about what a person is able to do functionally and can impair clear communication between providers. More recently, classification systems have been created employing a simple ordinal grading system of functional performance. These systems allow a more precise discussion between providers, as well as better subject stratification for research. The goal of this review is to describe four common functional classification systems for cerebral palsy: the Gross Motor Function Classification System (GMFCS), the Manual Ability Classification System (MACS), the Communication Function Classification System (CFCS), and the Eating and Drinking Ability Classification System (EDACS). These measures are all standardized, reliable, and complementary to one another.

  4. Healthcare sustainability and the challenges of innovation to biopharmaceuticals in Canada.

    Science.gov (United States)

    Rosenberg-Yunger, Zahava R S; Daar, Abdallah S; Singer, Peter A; Martin, Douglas K

    2008-09-01

    Governments around the world have focused on issues of sustainability, innovations and priority setting within their health systems. Tension exists between governments' desire to increase biotechnology innovation and the need to address health system sustainability. This commentary will: (1) review government initiatives in biotechnology in health innovation; (2) discuss how innovation, specifically biopharmaceuticals, challenges health system sustainability; and (3) explore how the tension between innovation and sustainability can be addressed using fairness and legitimacy. It is evident that a uni-jurisdictional approach may not be optimal in promoting innovation while ensuring a sustainable health system. Harmonization of biotechnology policies across the federal, provincial, and territorial governments will ensure consistent policies across all branches in order to circumvent the possibility of one governmental branch refusing to reimburse the very innovations other branches are promoting.

  5. Osteochondritis dissecans of the humeral capitellum: reliability of four classification systems using radiographs and computed tomography.

    Science.gov (United States)

    Claessen, Femke M A P; van den Ende, Kimberly I M; Doornberg, Job N; Guitton, Thierry G; Eygendaal, Denise; van den Bekerom, Michel P J

    2015-10-01

    The radiographic appearance of osteochondritis dissecans (OCD) of the humeral capitellum varies according to the stage of the lesion. It is important to evaluate the stage of OCD lesion carefully to guide treatment. We compared the interobserver reliability of currently used classification systems for OCD of the humeral capitellum to identify the most reliable classification system. Thirty-two musculoskeletal radiologists and orthopaedic surgeons specialized in elbow surgery from several countries evaluated anteroposterior and lateral radiographs and corresponding computed tomography (CT) scans of 22 patients to classify the stage of OCD of the humeral capitellum according to the classification systems developed by (1) Minami, (2) Berndt and Harty, (3) Ferkel and Sgaglione, and (4) Anderson on a Web-based study platform including a Digital Imaging and Communications in Medicine viewer. Magnetic resonance imaging was not evaluated as part of this study. We measured agreement among observers using the Siegel and Castellan multirater κ. All OCD classification systems, except for Berndt and Harty, which had poor agreement among observers (κ = 0.20), had fair interobserver agreement: κ was 0.27 for the Minami, 0.23 for Anderson, and 0.22 for Ferkel and Sgaglione classifications. The Minami Classification was significantly more reliable than the other classifications (P treatment in clinical practice as a result of this fair agreement. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  6. Danish translation and validation of the International Skin Tear Advisory Panel Skin Tear Classification System

    DEFF Research Database (Denmark)

    Skiveren, J; Bermark, S; LeBlanc, K

    2015-01-01

    ) and social and health-care assistants (non-RN) from both primary health care and a Danish university hospital in Copenhagen. Thirty photographs, with equal representation of the three types of skin tears, were selected to test validity. The photographs chosen were those originally used for internal.......443, respectively). CONCLUSION: The ISTAP Skin Tear Classification System was developed with the goal of establishing a global language for describing and documenting skin tears and to raise the health-care community's awareness of skin tears. The Danish translation of the ISTAP classification system supports......OBJECTIVE: The aim of this study was to translate, validate and establish reliability of the International Skin Tear Classification System in Danish. METHOD: Phase 1 of the project involved the translation of the International Skin Tear Advisory Panel (ISTAP) Skin Tear Classification System...

  7. Human error analysis of commercial aviation accidents using the human factors analysis and classification system (HFACS)

    Science.gov (United States)

    2001-02-01

    The Human Factors Analysis and Classification System (HFACS) is a general human error framework : originally developed and tested within the U.S. military as a tool for investigating and analyzing the human : causes of aviation accidents. Based upon ...

  8. Railroad classification yard technology : computer system methodology : case study : Potomac Yard

    Science.gov (United States)

    1981-08-01

    This report documents the application of the railroad classification yard computer system methodology to Potomac Yard of the Richmond, Fredericksburg, and Potomac Railroad Company (RF&P). This case study entailed evaluation of the yard traffic capaci...

  9. Methodological levels of abductive logic and its application in analyzing knowledge classification systems

    Directory of Open Access Journals (Sweden)

    Mohammad Khandan

    2015-05-01

    Originality/Value: Introduces methodological levels of abductive logic and provides LIS professionals with a new and alternative way for analyzing knowledge classification systems as interpretative and semantic social constructions.

  10. EULAR points to consider in the development of classification and diagnostic criteria in systemic vasculitis

    DEFF Research Database (Denmark)

    Basu, Neil; Watts, Richard; Bajema, Ingeborg

    2010-01-01

    The systemic vasculitides are multiorgan diseases where early diagnosis and treatment can significantly improve outcomes. Robust nomenclature reduces diagnostic delay. However, key aspects of current nomenclature are widely perceived to be out of date, these include disease definitions, classific...

  11. Financial Organization Information Security System Development using Modeling, IT assets and Accounts Classification Processes

    Directory of Open Access Journals (Sweden)

    Anton Sergeevich Zaytsev

    2013-12-01

    Full Text Available This article deals with processes of modeling, IT assets and account classification. Key principles of these processes configuration are pointed up. Also a model of Russian Federation banking system organization is developed.

  12. R-parametrization and its role in classification of linear multivariable feedback systems

    Science.gov (United States)

    Chen, Robert T. N.

    1988-01-01

    A classification of all the compensators that stabilize a given general plant in a linear, time-invariant multi-input, multi-output feedback system is developed. This classification, along with the associated necessary and sufficient conditions for stability of the feedback system, is achieved through the introduction of a new parameterization, referred to as R-Parameterization, which is a dual of the familiar Q-Parameterization. The classification is made to the stability conditions of the compensators and the plant by themselves; and necessary and sufficient conditions are based on the stability of Q and R themselves.

  13. Classification of mitral insufficiency and stenosis using MLP neural network and neuro-fuzzy system.

    Science.gov (United States)

    Barýpçý, Necaattin; Ergün, Uçman; Ilkay, Erdoğan; Serhatlýoğlu, Selami; Hardalaç, Firat; Güler, Inan

    2004-10-01

    Cardiac Doppler signals recorded from mitral valve of 60 patients were transferred to a personal computer by using a 16-bit sound card. The power spectral density (PSD) was applied to the recorded signal from each patient. In order to do a good interpretation and rapid diagnosis, PSD values classified using multilayer perceptron (MLP) and neuro-fuzzy system. Our findings demonstrated that 93.33% classification success rate was obtained from MLP, 90% classification success rate was obtained from neuro-fuzzy system. The classification results show that MLP offers best results in the case of diagnosis.

  14. HZI systems for EEG parametrization and classification of psychotropic drugs.

    Science.gov (United States)

    Itil, T M; Shapiro, D M; Herrmann, W M; Schulz, W; Morgan, V

    1979-01-01

    The EEG effects of twenty, clinically most frequently used psychotropic drugs and five placebos were studied in 75 male volunteers in five simultaneously designed basic studies. In each of the five studies single oral dosages of five drugs (well known representatives of neuroleptics, antidepressants, anxiolytics and psychostimulants, as well as placebos) were investigated in 15 subjects in a double-blind latin-square research design using the methods of the Quantitative Pharmaco-EEG. The results demonstrated that the therapeutically equivalent effective compounds also have similar effects on human EEG. With a classification rule, based on discriminant function 20, and with a classification rule, based on correlation statistics 19 of 25 compounds could be reclassified into correct clinical-therapeutic psychotropic drug groups. It is suggested that CEEG is an important tool in predicting and describing psychotropic properties of compounds, and should routinely be used in psychotropic drug development.

  15. EULAR points to consider in the development of classification and diagnostic criteria in systemic vasculitis

    DEFF Research Database (Denmark)

    Basu, Neil; Watts, Richard; Bajema, Ingeborg

    2010-01-01

    The systemic vasculitides are multiorgan diseases where early diagnosis and treatment can significantly improve outcomes. Robust nomenclature reduces diagnostic delay. However, key aspects of current nomenclature are widely perceived to be out of date, these include disease definitions, classific......, classification and diagnostic criteria. Therefore, the aim of the present work was to identify deficiencies and provide contemporary points to consider for the development of future definitions and criteria in systemic vasculitis....

  16. Manchester System: time spent on risk classification and priority of care at an emergency medical service.

    Science.gov (United States)

    Anziliero, Franciele; Dal Soler, Bárbara Elis; Silva, Bárbara Amaral da; Tanccini, Thaíla; Beghetto, Mariur Gomes

    2017-02-23

    To assess the time before and time spent on risk classification, priority of care, and destination of patients within 24 hours after their admission to an emergency medical service. Retrospective cohort study that included adults classified by the Manchester Triage System at the largest emergency medical service in the south of the country in 2012. The data were made available in the form of an electronic sheet and analyzed according to their characteristics and distribution. Of the 139,556 admissions, half of the patients arrived at classification within the time recommended (7; IQR: 2-20 minutes), and were classified within two (IQR: 1-3) minutes. Lower priority classifications and hospital discharges (88.4%) were more frequent than hospitalizations (11.4%) and deaths (0.2%). The time involved in activities that precede the first medical care remained within the recommendation. The proportion of lower priority classifications and hospital discharges within 24 hours after classification was high.

  17. A new classification code is available in the Danish health-care classification system for patients with symptoms related to chemicals and scents

    DEFF Research Database (Denmark)

    Elberling, Jesper; Bonde, Jens Peter Ellekilde; Vesterhauge, Søren

    2014-01-01

    From July 2012, a classification code for multiple chemical sensitivity has been available in the Danish healthcare classification system. The overall purpose is to register hospital contacts in Denmark. The diagnostic code is labelled "Symptoms related to chemicals and scents", DR688A1...

  18. Natural fracture systems on planetary surfaces: Genetic classification and pattern randomness

    Science.gov (United States)

    Rossbacher, Lisa A.

    1987-01-01

    One method for classifying natural fracture systems is by fracture genesis. This approach involves the physics of the formation process, and it has been used most frequently in attempts to predict subsurface fractures and petroleum reservoir productivity. This classification system can also be applied to larger fracture systems on any planetary surface. One problem in applying this classification system to planetary surfaces is that it was developed for ralatively small-scale fractures that would influence porosity, particularly as observed in a core sample. Planetary studies also require consideration of large-scale fractures. Nevertheless, this system offers some valuable perspectives on fracture systems of any size.

  19. Exposure assessment within a Total Diet Study: a comparison of the use of the pan-European classification system FoodEx-1 with national food classification systems.

    Science.gov (United States)

    Akhandaf, Y; Van Klaveren, J; De Henauw, S; Van Donkersgoed, G; Van Gorcum, T; Papadopoulos, A; Sirot, V; Kennedy, M; Pinchen, H; Ruprich, J; Rehurkova, I; Perelló, G; Sioen, I

    2015-04-01

    A Total Diet Study (TDS) consists of selecting, collecting and preparing commonly consumed foods purchased at retail level and analysing them for harmful and/or beneficial chemical substances. A food classification system is needed to link food consumption data with the contaminant concentration data obtained in the TDS for the exposure assessment. In this study a comparison was made between the use of a national food classification systems and the use of FoodEx-1, developed and recommended by the European Food Safety Authority (EFSA). The work was performed using data of six European countries: Belgium, Czech Republic, France, The Netherlands, Spain and the UK. For each population, exposure to contaminant A (organic compounds) and/or contaminant B (inorganic compound) was assessed by the Monte Carlo Risk Assessment (MCRA) software using the national classification system and FoodEx-1 for food consumption data and for TDS laboratory results. Minimal differences between both approaches were observed. This observation applied for both contaminant A and contaminant B. In general risk assessment will be similar for both approaches; however, this is not guaranteed. FoodEx-1 proved to be a valuable hierarchic classification system in order to harmonise exposure assessment based on existing TDS results throughout Europe. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Reliability of the Multidimensional Pain Inventory and stability of the MPI classification system in chronic back pain

    NARCIS (Netherlands)

    Verra, M.L.; Angst, F.; Staal, J.B.; Brioschi, R.; Lehmann, S.; Aeschlimann, A.; de Bie, R.A.

    2012-01-01

    ABSTRACT: BACKGROUND: This cross validation study examined the reliability of the Multidimensional Pain Inventory (MPI) and the stability of the Multidimensional Pain Inventory Classification System of the empirically derived subgroup classification obtained by cluster analysis in chronic

  1. Comparison of five systems of classification of diabetic foot ulcers and predictive factors for amputation.

    Science.gov (United States)

    Jeon, Byung-Joon; Choi, Hwan Jun; Kang, Jin Seok; Tak, Min Sung; Park, Eun Soo

    2017-06-01

    Diabetes mellitus is a common metabolic disorder. Among various complications, diabetic neuropathy and peripheral vascular disorders are closely associated with diabetic foot ulcers (DFUs). Lower extremity ulcers and amputations are ongoing problems among individuals with diabetes. There are several classification systems for DFUs; however, no prognostic system has to date been accepted as the gold standard or the optimum prediction tool for amputations. A retrospective study was designed. Demographic data and baseline laboratory data were gathered and scored or evaluated using five representative DFU classification systems. These included (i) the diabetic ulcer severity score (DUSS); (ii) University of Texas (UT) diabetic wound classification; (iii) Meggitt-Wagner classification; (iv) depth of the ulcer, extent of bacterial colonisation, phase of ulcer and association aetiology (DEPA) scoring system; and (v) site, ischaemia, neuropathy, bacterial infection and depth (SINBAD) score. Finally, a statistical analysis was performed. A total of 137 patients were included in this study. During the follow-up, DFU had healed in 51·1% of subjects and 48·9% of the individuals underwent lower extremity amputations (LEAs). In a univariable logistic regression analysis, history of previous DFU, hypertension, neuropathy, haemoglobin, C-reactive protein (CRP) and ankle-brachial index (ABI) showed a statistically significant difference between the healed group and the LEA group. Moreover, the stages, grades or overall prognostic ability of all five classifications were highly associated with the overall occurrence of LEA. On multivariable logistic regression analysis of the risk of LEA, all classifications showed a significant positive trend with an increased number of amputations. All the five classification systems exhibited high sensitivity, specificity, classification accuracy, positive predictive, negative predictive and area under the curve (AUC) values. They showed

  2. MRI classification system (MRICS) for children with cerebral palsy: development, reliability, and recommendations.

    Science.gov (United States)

    Himmelmann, Kate; Horber, Veronka; De La Cruz, Javier; Horridge, Karen; Mejaski-Bosnjak, Vlatka; Hollody, Katalin; Krägeloh-Mann, Ingeborg

    2017-01-01

    To develop and evaluate a classification system for magnetic resonance imaging (MRI) findings of children with cerebral palsy (CP) that can be used in CP registers. The classification system was based on pathogenic patterns occurring in different periods of brain development. The MRI classification system (MRICS) consists of five main groups: maldevelopments, predominant white matter injury, predominant grey matter injury, miscellaneous, and normal findings. A detailed manual for the descriptions of these patterns was developed, including test cases (www.scpenetwork.eu/en/my-scpe/rtm/neuroimaging/cp-neuroimaging/). A literature review was performed and MRICS was compared with other classification systems. An exercise was carried out to check applicability and interrater reliability. Professionals working with children with CP or in CP registers were invited to participate in the exercise and chose to classify either 18 MRIs or MRI reports of children with CP. Classification systems in the literature were compatible with MRICS and harmonization possible. Interrater reliability was found to be good overall (k=0.69; 0.54-0.82) among the 41 participants and very good (k=0.81; 0.74-0.92) using the classification based on imaging reports. Surveillance of Cerebral Palsy in Europe (SCPE) proposes the MRICS as a reliable tool. Together with its manual it is simple to apply for CP registers. © 2016 Mac Keith Press.

  3. Biopharmaceutical aspects of oral drug delivery

    NARCIS (Netherlands)

    Faassen, Werenfriedus Adrianus

    2004-01-01

    Most drugs display their therapeutic activity on specific places in the human body and should reach the systemic circulation in order to be transported towards the site of action. Irrespective of the route of administration the same sequence of steps are of relevance for the exposure to a drug:

  4. A radiographic classification system in juvenile rheumatoid arthritis applied to the knee

    International Nuclear Information System (INIS)

    Dale, K.; Paus, A.C.; Laires, K.

    1994-01-01

    A new radiographic grading system for evaluation of juvenile rheumatoid arthritis (JRA) for the knee is presented. The classification is based on known arthritic criteria in childhood. Joints with erosion are given a higher score than growth disturbances alone. Signs of osteoarthrosis including joint space narrowing were excluded from the classification. The femorotibial and patello-femoral joints are assessed together. Verbal definitions are used for the classification, but, regarding the erosions, standard reference films are used. The intra- and inter-observer variations of the method were low. (P < 0.01) (orig.)

  5. British athletics muscle injury classification: a reliability study for a new grading system

    International Nuclear Information System (INIS)

    Patel, A.; Chakraverty, J.; Pollock, N.; Chakraverty, R.; Suokas, A.K.; James, S.L.

    2015-01-01

    Aim: To implement and validate the newly proposed British athletics muscle injury classification in the assessment of hamstring injuries in track and field athletes and to analyse the nature and frequency of the discrepancies. Materials and methods: This was a retrospective study analysing hamstring injuries in elite British athletes using the proposed classification system. Classification of 65 hamstring injuries in 45 high-level athletes by two radiologists at two time points 4 months apart to determine interrater variability, intrarater variability, and feasibility of the classification system was undertaken. Results: Interrater Kappa values of 0.80 (95% confidence interval [CI]: 0.67–0.92; p<0.0001) for Round 1 and 0.88 (95% CI: 0.76–1.00; p<0.0001) for Round 2 of the review were observed. Percentages of agreement were 85% for Round 1 and 91% for Round 2. The intrarater Kappa value for the two reviewers were 0.76 (95% CI: 0.63–0.88; p<0.0001) and 0.65 (95% CI: 0.53–0.76; p<0.0001) and the average was 0.71 suggesting substantial overall agreement. The percentages of agreement were 82% and 72%, respectively. Conclusions: This classification system is straightforward to use and produces both reproducible and consistent results based on interrater and intrarater Kappa values with at least substantial agreement in all groups. Further work is ongoing to investigate whether individual grades within this classification system provide prognostic information and could guide clinical management. - Highlights: • This classification system is based on MRI parameters shown to have prognostic relevance. • It is simple to use, reproducible and clinically relevant which will enhance clinical practice. • Once clinicians are familiar with the classification inter & intrarater reliability will improve.

  6. Semiologic classification of psychogenic non epileptic seizures (PNES) based on video EEG analysis: do we need new classification systems?

    Science.gov (United States)

    Wadwekar, Vaibhav; Nair, Pradeep Pankajakshan; Murgai, Aditya; Thirunavukkarasu, Sibi; Thazhath, Harichandrakumar Kottyen

    2014-03-01

    Different studies have described useful signs to diagnose psychogenic non-epileptic seizure (PNES). A few authors have tried to describe the semiologic groups among PNES patients; each group consisting of combination of features. But there is no uniformity of nomenclature among these studies. Our aim was to find out whether the objective classification system proposed by Hubsch et al. was useful and adequate to classify PNES patient population from South India. We retrospectively analyzed medical records and video EEG monitoring data of patients, recorded during 3 year period from June 2010 to July 2013. We observed the semiologic features of each PNES episode and tried to group them strictly adhering to Hubsch et al. classification. Minor modifications were made to include patients who were left unclassified. A total of 65 patients were diagnosed to have PNES during this period, out of which 11 patients were excluded due to inadequate data. We could classify 42(77.77%) patients without modifying the defining criteria of the Hubsch et al. groups. With minor modification we could classify 94.96% patients. The modified groups with patient distribution are as follows: Class 1--dystonic attacks with primitive gestural activities [3(5.6%)]. Class 2 – paucikinetic attacks with or without preserved responsiveness [5(9.3%)]. Class 3--pseudosyncope with or without hyperventilation [21(38.9%)]. Class 4--hyperkinetic prolonged attacks with hyperventilation, involvement of limbs and/or trunk [14(25.9%)]. Class 5--axial dystonic attacks [8(14.8%)]. Class 6--unclassified type [3(5.6%)]. This study demonstrates that the Hubsch's classification with minor modifications is useful and adequate to classify PNES patients from South India. Copyright © 2013 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  7. Systems Approach to Standardisation, Classification and Modelling of Managed Events for Tourism

    Directory of Open Access Journals (Sweden)

    Jakulin Tadeja Jere

    2015-08-01

    Full Text Available Background and Purpose: The standardisation and classification of managed events provide a legislative basis to distinguish events managed for tourism in their characteristics and quality. The systems approach to standardisation and classification of managed events is a unique, holistic view of event management quality and event organization in tourism. It enables a clear overview of a researched topic and provides adequate support to design and decision-making. In this paper, we explain the meaning of standardisation and classification for Slovenian legislation related to event management. We present the importance of a systems approach methodology for event categorization and classification as it relates to the quality of event management organization, the quality of staff, the quality of the event program and the quality of event services.

  8. Human-interpretable feature pattern classification system using learning classifier systems.

    Science.gov (United States)

    Ebadi, Toktam; Kukenys, Ignas; Browne, Will N; Zhang, Mengjie

    2014-01-01

    Image pattern classification is a challenging task due to the large search space of pixel data. Supervised and subsymbolic approaches have proven accurate in learning a problem's classes. However, in the complex image recognition domain, there is a need for investigation of learning techniques that allow humans to interpret the learned rules in order to gain an insight about the problem. Learning classifier systems (LCSs) are a machine learning technique that have been minimally explored for image classification. This work has developed the feature pattern classification system (FPCS) framework by adopting Haar-like features from the image recognition domain for feature extraction. The FPCS integrates Haar-like features with XCS, which is an accuracy-based LCS. A major contribution of this work is that the developed framework is capable of producing human-interpretable rules. The FPCS system achieved 91 [Formula: see text] 1% accuracy on the unseen test set of the MNIST dataset. In addition, the FPCS is capable of autonomously adjusting the rotation angle in unaligned images. This rotation adjustment raised the accuracy of FPCS to 95%. Although the performance is competitive with equivalent approaches, this was not as accurate as subsymbolic approaches on this dataset. However, the benefit of the interpretability of rules produced by FPCS enabled us to identify the distribution of the learned angles-a normal distribution around [Formula: see text]-which would have been very difficult in subsymbolic approaches. The analyzable nature of FPCS is anticipated to be beneficial in domains such as speed sign recognition, where underlying reasoning and confidence of recognition needs to be human interpretable.

  9. An Expert System for Diagnosis of Sleep Disorder Using Fuzzy Rule-Based Classification Systems

    Science.gov (United States)

    Septem Riza, Lala; Pradini, Mila; Fitrajaya Rahman, Eka; Rasim

    2017-03-01

    Sleep disorder is an anomaly that could cause problems for someone’ sleeping pattern. Nowadays, it becomes an issue since people are getting busy with their own business and have no time to visit the doctors. Therefore, this research aims to develop a system used for diagnosis of sleep disorder using Fuzzy Rule-Based Classification System (FRBCS). FRBCS is a method based on the fuzzy set concepts. It consists of two steps: (i) constructing a model/knowledge involving rulebase and database, and (ii) prediction over new data. In this case, the knowledge is obtained from experts whereas in the prediction stage, we perform fuzzification, inference, and classification. Then, a platform implementing the method is built with a combination between PHP and the R programming language using the “Shiny” package. To validate the system that has been made, some experiments have been done using data from a psychiatric hospital in West Java, Indonesia. Accuracy of the result and computation time are 84.85% and 0.0133 seconds, respectively.

  10. Terminology and classification aspects of the Bethesda System for Reporting Thyroid Cytopathology

    Directory of Open Access Journals (Sweden)

    G V Semkina

    2012-12-01

    Full Text Available The article is devoted to the relevance of Betesda System for Reporting Thyroid Cytopathology. This article summarizes recent data on the main differences and advantages of new classification system. Application of the Betesda System for Reporting Thyroid Cytopathology leads to the increased sensitivity and specificity of FNA.

  11. Global Stress Classification System for Materials Used in Solar Energy Applications

    Science.gov (United States)

    Slamova, Karolina; Schill, Christian; Herrmann, Jan; Datta, Pawan; Chih Wang, Chien

    2016-08-01

    Depending on the geographical location, the individual or combined impact of environmental stress factors and corresponding performance losses for solar applications varies significantly. Therefore, as a strategy to reduce investment risks and operating and maintenance costs, it is necessary to adapt the materials and components of solar energy systems specifically to regional environmental conditions. The project «GloBe Solar» supports this strategy by focusing on the development of a global stress classification system for materials in solar energy applications. The aim of this classification system is to assist in the identification of the individual stress conditions for every location on the earth's surface. The stress classification system could serve as a decision support tool for the industry (manufacturers, investors, lenders and project developers) and help to improve knowledge and services that can provide higher confidence to solar power systems.

  12. Dens invaginatus and treatment options based on a classification system: report of a type II invagination.

    Science.gov (United States)

    Kristoffersen, Ø; Nag, O H; Fristad, I

    2008-08-01

    To give an overview of treatment options for dens invaginatus based on a classification system. Dens invaginatus is a dental malformation which may give endodontic complications. Treatment may vary in relation to anatomy, and a classification system for dens invaginatus forms the basis for discussion. A clinical case, classified as a type II invagination (Oehlers' classification), is also presented. Clinical and radiographic examination revealed an invagination penetrating into the apical third of the root canal in tooth number 12. The tooth was immature with an open apex, apical pathosis and a labial fistula. To control the infection, ultrasonic removal of the invagination was necessary, as the invagination prevented complete cleaning and shaping of the root canal. After chemo-mechanical preparation and dressing with calcium hydroxide, an apical plug of MTA was placed, followed by restoration of the tooth with resin-bonded composite. Healing of the lesion with hard tissue formation was confirmed at follow-up. KEY LEARNING POINTS * Knowledge about classification and anatomical variations of teeth with dens invaginatus is important in endodontic decision making. * A classification system may be helpful when treatment options are considered. * Classification of dens invaginatus requires a thorough preoperative radiographic examination.

  13. New classification system of endometrial hyperplasia WHO 2014 and its clinical implications

    Directory of Open Access Journals (Sweden)

    Katarzyna Sobczuk

    2017-10-01

    Full Text Available Endometrial hyperplasia (EH is a pathological condition characterised by hyperplastic changes in endometrial glandular and stromal structures lining the uterine cavity. Endometrial hyperplasia, particularly with atypia, is a significant clinical concern because it can be a precursor of endometrial cancer. Accurate diagnosis of precancerous lesions of the endometrium and exclusion of coexisting endometrial carcinomas are absolutely required for the optimal management of patients. The classification of endometrial hyperplasia has had numerous terminology. According to the classification of WHO94, based on glandular complexity and nuclear atypia, EH is divided into four groups: non-atypical endometrial hyperplasia (simple, complex and atypical endometrial hyperplasia (simple, complex. Estimated risk of progression of atypical hyperplasia to endometrial cancer is 8-29%. The American College of Obstetricians and Gynaecologists and the Society of Gynaecological Oncology states that endometrial intraepithelial neoplasia (EIN classification is superior to the World Health Organisation (WHO 94 classification for histology of endometrial hyperplasia. However, the WHO classification system remains the most commonly used and reported in existing literature. The new classification, WHO 2014, accepted by the International Society of Gynaecological Pathologists, divided hyperplasia into two groups: benign hyperplasia and atypical hyperplasia/endometrial intraepithelial neoplasia (EIN. The WHO 2014 schema is more likely to successfully identify precancerous lesions than the WHO94 classification.

  14. Classification of weld defect based on information fusion technology for radiographic testing system

    Energy Technology Data Exchange (ETDEWEB)

    Jiang, Hongquan; Liang, Zeming, E-mail: heavenlzm@126.com; Gao, Jianmin; Dang, Changying [State Key Laboratory for Manufacturing System Engineering, Department of Mechanical Engineering, Xi’an Jiaotong University, Xi’an 710049 (China)

    2016-03-15

    Improving the efficiency and accuracy of weld defect classification is an important technical problem in developing the radiographic testing system. This paper proposes a novel weld defect classification method based on information fusion technology, Dempster–Shafer evidence theory. First, to characterize weld defects and improve the accuracy of their classification, 11 weld defect features were defined based on the sub-pixel level edges of radiographic images, four of which are presented for the first time in this paper. Second, we applied information fusion technology to combine different features for weld defect classification, including a mass function defined based on the weld defect feature information and the quartile-method-based calculation of standard weld defect class which is to solve a sample problem involving a limited number of training samples. A steam turbine weld defect classification case study is also presented herein to illustrate our technique. The results show that the proposed method can increase the correct classification rate with limited training samples and address the uncertainties associated with weld defect classification.

  15. Applying inventory classification to a large inventory management system

    Directory of Open Access Journals (Sweden)

    Benjamin Isaac May

    2017-06-01

    Full Text Available Inventory classification aims to ensure that business-driving inventory items are efficiently managed in spite of constrained resources. There are numerous single- and multiple-criteria approaches to it. Our objective is to improve resource allocation to focus on items that can lead to high equipment availability. This concern is typical of many service industries such as military logistics, airlines, amusement parks and public works. Our study tests several inventory prioritization techniques and finds that a modified multi-criterion weighted non-linear optimization (WNO technique is a powerful approach for classifying inventory, outperforming traditional techniques of inventory prioritization such as ABC analysis in a variety of performance objectives.

  16. About camel breeds: A reevaluation of current classification systems.

    Science.gov (United States)

    Köhler-Rollefson, I

    1993-01-12

    This article revaluates the current dromedary breed classifications based on Leese's (1927) division into hills, riverine and plains camel according to camel breeding zones, and the even earlier distinction by Cross (1917) and Leonard (1894) between baggage and riding camels. It is suggested that these classifications are inappropriate to portray the wide variety of camel breeds actually existing, since they do not accurately reflect the ecological context of camel breeding and also depict incompletely the actual uses to which camels are put in camel pastoral societies. The breeding practices of traditional camel pastoral societies are described and discussed, and it is concluded that these have been conducive to the development of a large number of specialized camel breeds. It is pointed out that many camel breeds are endangered, and that it is imperative to take steps for their documentation. ZUSAMMENFASSUNG: Kamelrassen: Revision des gegenwärtigen Klassifikationssystems In diesem Artikel werden die heute gebräuchlichen Klassifikationssysteme für Dromedarrassen einer Prüfung unterzogen: Diese beruhen auf der Einteilung von Leese (1927) nach Kamelzuchtgebieten in Berg-, Fluß- und Flachlandkamele und der noch älteren Unterscheidung von Cross (1917) und Leonard (1894) zwischen Reit- und Lastkamelen. Es wird vorgeschlagen, daß diese Einteilungen der tatsächlichen Variabilität zwischen Kamelrassen nicht gerecht werden, weil sie die ökologischen Bedingungen, unter denen Kamelzucht betrieben wird, nicht richtig reflektieren und die tatsächlichen Nutzungsweisen, denen das Kamel in Kamelhirtenkulturen unterzogen wird, nur unvollständig wiedergeben. Die Zuchtmethoden traditioneller Kamelhirten werden beschrieben und diskutiert, und es wird die Schlußfolgerung gezogen, daß diese für die Herausbildung vieler spezialisierter Rassen ideale Vorbedingungen darstellten. Auf die große Gefahr des Verlustes vieler dieser Rassen und die Notwendigkeit diese zu

  17. Classification of transportation packaging and dry spent fuel storage system components according to importance to safety

    International Nuclear Information System (INIS)

    Tyacke, M.J.; McConnell, J.W. Jr.; Ayers, A.L. Jr.; O'Connor, S.C.; Jankovich, J.P.

    1996-01-01

    The Idaho National Engineering Laboratory prepared a technical report for the Office of Nuclear Material Safety and Safeguards of the US Nuclear Regulatory Commission, entitled Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety, NUREG/CR-6407. This paper provides the results of that report. It also presents the graded approach for classification of components used in transportation packagings and dry spent fuel storage systems. This approach provides a method for identifying the classification of components according to importance to safety within transportation packagings and dry spent fuel storage systems. Record retention requirements are discussed to identify the documentation necessary to validate that the individual components were fabricated in accordance with their assigned classification. A review of the existing regulations pertaining to transportation packagings and dry storage systems was performed to identify current requirements. The general types of transportation packagings and dry storage systems are identified. The methodology used in this paper is based on Regulatory Guide 7.10, Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material. This paper also includes a list of generic components for each of the general types of transportation packagings and spent fuel storage systems, with a classification category assigned to each component. Several examples concerning the safety importance of components are presented

  18. Biopharmaceutical industry-sponsored global clinical trials in emerging countries.

    Science.gov (United States)

    Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira

    2010-01-01

    To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (pBrazil. Trials involving subjects with less than 15 years of age, those with targeted recruitment of at least 1,000 subjects, and seven sponsors were identified as significant predictors of trial placement in Brazil. No clear direct competition between Brazil and other emerging countries was detected. South Korea showed the higher proportion of sites and ranked third in total number of trials, appearing as a major player in attractiveness for biopharmaceutical industry-sponsored clinical trials.

  19. Biopharmaceutical Process Optimization with Simulation and Scheduling Tools.

    Science.gov (United States)

    Petrides, Demetri; Carmichael, Doug; Siletti, Charles; Koulouris, Alexandros

    2014-09-29

    Design and assessment activities associated with a biopharmaceutical process are performed at different levels of detail, based on the stage of development that the product is in. Preliminary "back-of-the envelope" assessments are performed early in the development lifecycle, whereas detailed design and evaluation are performed prior to the construction of a new facility. Both the preliminary and detailed design of integrated biopharmaceutical processes can be greatly assisted by the use of process simulators, discrete event simulators or finite capacity scheduling tools. This report describes the use of such tools for bioprocess development, design, and manufacturing. The report is divided into three sections. Section One provides introductory information and explains the purpose of bioprocess simulation. Section Two focuses on the detailed modeling of a single batch bioprocess that represents the manufacturing of a therapeutic monoclonal antibody (MAb). This type of analysis is typically performed by engineers engaged in the development and optimization of such processes. Section Three focuses on production planning and scheduling models for multiproduct plants.

  20. Biopharmaceutical Process Optimization with Simulation and Scheduling Tools

    Directory of Open Access Journals (Sweden)

    Demetri Petrides

    2014-09-01

    Full Text Available Design and assessment activities associated with a biopharmaceutical process are performed at different levels of detail, based on the stage of development that the product is in. Preliminary “back-of-the envelope” assessments are performed early in the development lifecycle, whereas detailed design and evaluation are performed prior to the construction of a new facility. Both the preliminary and detailed design of integrated biopharmaceutical processes can be greatly assisted by the use of process simulators, discrete event simulators or finite capacity scheduling tools. This report describes the use of such tools for bioprocess development, design, and manufacturing. The report is divided into three sections. Section One provides introductory information and explains the purpose of bioprocess simulation. Section Two focuses on the detailed modeling of a single batch bioprocess that represents the manufacturing of a therapeutic monoclonal antibody (MAb. This type of analysis is typically performed by engineers engaged in the development and optimization of such processes. Section Three focuses on production planning and scheduling models for multiproduct plants.

  1. The transgenic animal platform for biopharmaceutical production.

    Science.gov (United States)

    Bertolini, L R; Meade, H; Lazzarotto, C R; Martins, L T; Tavares, K C; Bertolini, M; Murray, J D

    2016-06-01

    The recombinant production of therapeutic proteins for human diseases is currently the largest source of innovation in the pharmaceutical industry. The market growth has been the driving force on efforts for the development of new therapeutic proteins, in which transgenesis emerges as key component. The use of the transgenic animal platform offers attractive possibilities, residing on the low production costs allied to high productivity and quality of the recombinant proteins. Although many strategies have evolved over the past decades for the generation of transgenic founders, transgenesis in livestock animals generally faces some challenges, mainly due to random transgene integration and control over transgene copy number. But new developments in gene editing with CRISPR/Cas system promises to revolutionize the field for its simplicity and high efficiency. In addition, for the final approval of any given recombinant protein for animal or human use, the production and characterization of bioreactor founders and expression patterns and functionality of the proteins are technical part of the process, which also requires regulatory and administrative decisions, with a large emphasis on biosafety. The approval of two mammary gland-derived recombinant proteins for commercial and clinical use has boosted the interest for more efficient, safer and economic ways to generate transgenic founders to meet the increasing demand for biomedical proteins worldwide.

  2. Assessing three fuel classification systems and their maps using Forest Inventory and Analysis (FIA) surface fuel measurements

    Science.gov (United States)

    Robert E. Keane; Jason M. Herynk; Chris Toney; Shawn P. Urbanski; Duncan C. Lutes; Roger D. Ottmar

    2015-01-01

    Fuel classifications are integral tools in fire management and planning because they are used as inputs to fire behavior and effects simulation models. Fuel Loading Models (FLMs) and Fuel Characteristic Classification System (FCCSs) fuelbeds are the most popular classifications used throughout wildland fire science and management, but they have yet to be thoroughly...

  3. Biopharmaceutical protein production bySaccharomyces cerevisiae: current state and future prospects

    DEFF Research Database (Denmark)

    Huang, Mingtao; Bao, Jichen; Nielsen, Jens

    2014-01-01

    In the past few decades there has been an increasing demand of biopharmaceutical proteins in the market. Several types of cell factories are applied to produce different pharmaceutical proteins. However, manufacturers prefer to use a few favorable biological platforms to undertake the production...... tasks with low cost, high productivity and proper post-translational modifications. The yeast Saccharomyces cerevisiae is one of these preferred cell factories as it meets many of the requirements. There are several reports on improvement of recombinant protein production by S. cerevisiae through...... rational engineering of different stages of the protein secretion pathway. However, recent developments of new technologies like systems biology and synthetic biology open new doors to design S. cerevisiae as an ideal production platform....

  4. Assessing the Inventiveness of Bio-Pharmaceuticals under European and US Patent Law

    DEFF Research Database (Denmark)

    Minssen, Timo

    specifically, it investigates how the European and US patent systems interpret and apply the so called "inventive step" (Europe) or "non-obviousness" requirement (U.S.) vis-à-vis bio-pharmaceutical technology with a special emphasis on DNA-and protein related inventions. In addition to evaluating the de lata...... with DNA- and protein related patents is often difficult to assess and depends on a variety of “pre-grant“ and “post-grant” factors that fall outside the scope of the analysis, this study highlights the importance of a properly balanced and stringent application of the inventive step......“The implications and applications of biotechnology continue to be at the centre of public debate. In the light of rapid scientific advances and novel insights, the multi-faceted discussions are particularly fierce with regard to patents on DNA–related technology. In the often very emotionally...

  5. Classification of Aeronautics System Health and Safety Documents

    Data.gov (United States)

    National Aeronautics and Space Administration — Most complex aerospace systems have many text reports on safety, maintenance, and associated issues. The Aviation Safety Reporting System (ASRS) spans several...

  6. An approach for classification of hydrogeological systems at the regional scale based on groundwater hydrographs

    Science.gov (United States)

    Haaf, Ezra; Barthel, Roland

    2016-04-01

    When assessing hydrogeological conditions at the regional scale, the analyst is often confronted with uncertainty of structures, inputs and processes while having to base inference on scarce and patchy data. Haaf and Barthel (2015) proposed a concept for handling this predicament by developing a groundwater systems classification framework, where information is transferred from similar, but well-explored and better understood to poorly described systems. The concept is based on the central hypothesis that similar systems react similarly to the same inputs and vice versa. It is conceptually related to PUB (Prediction in ungauged basins) where organization of systems and processes by quantitative methods is intended and used to improve understanding and prediction. Furthermore, using the framework it is expected that regional conceptual and numerical models can be checked or enriched by ensemble generated data from neighborhood-based estimators. In a first step, groundwater hydrographs from a large dataset in Southern Germany are compared in an effort to identify structural similarity in groundwater dynamics. A number of approaches to group hydrographs, mostly based on a similarity measure - which have previously only been used in local-scale studies, can be found in the literature. These are tested alongside different global feature extraction techniques. The resulting classifications are then compared to a visual "expert assessment"-based classification which serves as a reference. A ranking of the classification methods is carried out and differences shown. Selected groups from the classifications are related to geological descriptors. Here we present the most promising results from a comparison of classifications based on series correlation, different series distances and series features, such as the coefficients of the discrete Fourier transform and the intrinsic mode functions of empirical mode decomposition. Additionally, we show examples of classes

  7. Development of an intelligent system for ultrasonic flaw classification in weldments

    International Nuclear Information System (INIS)

    Song, Sung-Jin; Kim, Hak-Joon; Cho, Hyeon

    2002-01-01

    Even though ultrasonic pattern recognition is considered as the most effective and promising approach to flaw classification in weldments, its application to the realistic field inspection is still very limited due to the crucial barriers in cost, time and reliability. To reduce such barriers, previously we have proposed an intelligent system approach that consisted of the following four ingredients: (1) a PC-based ultrasonic testing (PC-UT) system; (2) an effective invariant ultrasonic flaw classification algorithm; (3) an intelligent flaw classification software; and (4) a database with abundant experimental flaw signals. In the present work, for performing the ultrasonic flaw classification in weldments in a real-time fashion in many real word situations, we develop an intelligent system, which is called the 'Intelligent Ultrasonic Evaluation System (IUES)' by the integration of the above four ingredients into a single, unified system. In addition, for the improvement of classification accuracy of flaws, especially slag inclusions, we expand the feature set by adding new informative features, and demonstrate the enhanced performance of the IUES with flaw signals in the database constructed previously. And then, to take care of the increased redundancy in the feature set due to the addition of features, we also propose two efficient schemes for feature selection: the forward selection with trial and error, and the forward selection with criteria of the error probability and the linear correlation coefficients of individual features

  8. Optimization of Neuro-Fuzzy System Using Genetic Algorithm for Chromosome Classification

    Directory of Open Access Journals (Sweden)

    M. Sarosa

    2013-09-01

    Full Text Available Neuro-fuzzy system has been shown to provide a good performance on chromosome classification but does not offer a simple method to obtain the accurate parameter values required to yield the best recognition rate. This paper presents a neuro-fuzzy system where its parameters can be automatically adjusted using genetic algorithms. The approach combines the advantages of fuzzy logic theory, neural networks, and genetic algorithms. The structure consists of a four layer feed-forward neural network that uses a GBell membership function as the output function. The proposed methodology has been applied and tested on banded chromosome classification from the Copenhagen Chromosome Database. Simulation result showed that the proposed neuro-fuzzy system optimized by genetic algorithms offers advantages in setting the parameter values, improves the recognition rate significantly and decreases the training/testing time which makes genetic neuro-fuzzy system suitable for chromosome classification.

  9. Blastocyst classification systems used in Latin America: is a consensus possible?

    Science.gov (United States)

    Puga-Torres, Tatiana; Blum-Rojas, Xavier; Blum-Narváez, Medardo

    2017-09-01

    To identify different blastocyst classification systems used by embryologists in Latin American countries and evaluate the possibility of establishing a consensus among these countries. An E-mail survey was carried out through the Latin American Network of Assisted Reproduction (REDLARA) aimed at embryologists from assisted reproduction centers in Latin countries. Sixty surveys were collected from 12 Latin American countries, of which 66.7% had >10years of professional practice as embryologists. Seven different blastocyst classification systems were reported, of which 5 have previously been described in the literature. Although the group of embryologists surveyed use different blastocyst classification systems, most in this group consider that the embryo score system should be unified in their countries as well as in the region.

  10. Intraobserver and interobserver reliability assessment of tibial plateau fracture classification systems.

    Science.gov (United States)

    Taşkesen, Anıl; Demirkale, İsmail; Okkaoğlu, Mustafa Caner; Özdemir, Mahmut; Bilgili, Mustafa Gökhan; Altay, Murat

    2017-12-01

    This study aims to assess the intra- and interobserver reliability of commonly used tibial plateau fracture classification systems. This retrospective cohort study included computed tomography (CT) and plain radiographic images (lateral and anteroposterior X-rays) of 60 patients (40 males, 20 females; mean age 45.9 years; range 18 to 80 years) who presented to two orthopaedic clinics between January 2011 and January 2015 with unilateral tibial plateau fractures. All plain X-rays (XR) and CT images were evaluated by four observers on two separate occasions, 1.5 months apart. All fractures were classified according to the Arbeitsgemeinschaft für Osteosynthesefragen-Orthopaedic Trauma Association (AO-OTA), Schatzker, Hohl and Moore, Luo and revised Duparc systems. Intraobserver reliability was measured with Cohen's kappa (κ) coefficient and interobserver reliability with Fleiss' kappa coefficient. When Schatzker classification was performed, interobserver reliability was in moderate level for (κ=0.51) for XR and in substantial level for CT (κ=0.61). When AO/OTA classification was used, interobserver reliability was in moderate level for both methods of diagnosis (κXR=0.43 and κCT=0.54, respectively). In the Hohl and Moore classification, the interobserver reliability was also moderate for both methods of diagnosis (κXR=0.45 and κCT=0.51, respectively). Revised Duparc classification showed the lowest interobserver reliability ranging from fair to moderate level (κXR=0.27-0.55 and κCT=0.44-0.61). Interobserver reliability for Luo classification was κCT=0.47. Intraobserver reliability for CT in Luo classification was in substantial level for observers 1, 2 and 3 (κCT=0.67-0.71) and in perfect level for observer 4 (κCT=0.84). Intraobserver reliability was in substantial level in Schatzker classification and in moderate level at the other classifications. Among the classification systems compared in this study, Schatzker was the most reliable particularly when

  11. Reflecting on the structure of soil classification systems: insights from a proposal for integrating subsoil data into soil information systems

    Science.gov (United States)

    Dondeyne, Stefaan; Juilleret, Jérôme; Vancampenhout, Karen; Deckers, Jozef; Hissler, Christophe

    2017-04-01

    Classification of soils in both World Reference Base for soil resources (WRB) and Soil Taxonomy hinges on the identification of diagnostic horizons and characteristics. However as these features often occur within the first 100 cm, these classification systems convey little information on subsoil characteristics. An integrated knowledge of the soil, soil-to-substratum and deeper substratum continuum is required when dealing with environmental issues such as vegetation ecology, water quality or the Critical Zone in general. Therefore, we recently proposed a classification system of the subsolum complementing current soil classification systems. By reflecting on the structure of the subsoil classification system which is inspired by WRB, we aim at fostering a discussion on some potential future developments of WRB. For classifying the subsolum we define Regolite, Saprolite, Saprock and Bedrock as four Subsolum Reference Groups each corresponding to different weathering stages of the subsoil. Principal qualifiers can be used to categorize intergrades of these Subsoil Reference Groups while morphologic and lithologic characteristics can be presented with supplementary qualifiers. We argue that adopting a low hierarchical structure - akin to WRB and in contrast to a strong hierarchical structure as in Soil Taxonomy - offers the advantage of having an open classification system avoiding the need for a priori knowledge of all possible combinations which may be encountered in the field. Just as in WRB we also propose to use principal and supplementary qualifiers as a second level of classification. However, in contrast to WRB we propose to reserve the principal qualifiers for intergrades and to regroup the supplementary qualifiers into thematic categories (morphologic or lithologic). Structuring the qualifiers in this manner should facilitate the integration and handling of both soil and subsoil classification units into soil information systems and calls for paying

  12. The Market of Biopharmaceutical Medicines: A Snapshot of a Diverse Industrial Landscape

    Directory of Open Access Journals (Sweden)

    Evelien Moorkens

    2017-06-01

    Full Text Available Background: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market.Objectives: This study aims to identify and document which investment and development strategies are adopted by industrial players in the global biopharmaceutical market.Methods: A descriptive analysis was undertaken of the investment and development strategies of the top 25 pharmaceutical companies according to 2015 worldwide prescription drug sales. Strategies were documented by collecting data on manufacturing plans, development programs, acquisition and collaboration agreements, the portfolio and pipeline of biosimilar, originator and next-generation biopharmaceutical products. Data were extracted from publicly available sources.Results: Various investment and development strategies can be identified in the global biopharmaceutical market: (a development of originator biopharmaceuticals, (b investment in biotechnology, (c development of next-generation biopharmaceuticals, (d development of biosimilars, (e investment in emerging countries, and (f collaboration between companies. In the top 25 pharmaceutical companies almost every company invests in originator biopharmaceuticals and in biotechnology in general, but only half of them develops next-generation biopharmaceuticals. Furthermore, only half of them invest in development of biosimilars. The companies' biosimilar pipeline is mainly focused on development of biosimilar monoclonal antibodies and to some extent on biosimilar insulins. A common strategy is collaboration between companies and investment in emerging countries.Conclusions: A snapshot of investment and development strategies used by industrial players in the global biopharmaceutical market shows that all top 25 pharmaceutical companies are engaged in the biopharmaceutical market and

  13. Classification Systems, their Digitization and Consequences for Data-Driven Decision Making

    DEFF Research Database (Denmark)

    Stein, Mari-Klara; Newell, Sue; Galliers, Robert D.

    2013-01-01

    of such information systems. Based on a multi-site field study, we suggest that representational quality is achieved through four types of negotiations that human actors engage in when confronted with the materiality of a new IS. These negotiations are associated with three broad practices (instantiation, re......-narration and meta-narration), and three different information production/consumption situations. We contribute to the relational theorization of representational quality and extend classification systems research by drawing explicit attention to the importance of ‘materialization’ of classification systems...

  14. International society of neuropathology-haarlem consensus guidelines for nervous system tumor classification and grading

    NARCIS (Netherlands)

    Louis, D.N.; Perry, A.; Burger, P.; Ellison, D.W.; Reifenberger, G.; Deimling, A. Von; Aldape, K.; Brat, D.; Collins, V.P.; Eberhart, C.; Figarella-Branger, D.; Fuller, G.N.; Giangaspero, F.; Giannini, C.; Hawkins, C.; Kleihues, P.; Korshunov, A.; Kros, J.M.; Lopes, M. Beatriz; Ng, H.K.; Ohgaki, H.; Paulus, W.; Pietsch, T.; Rosenblum, M.; Rushing, E.; Soylemezoglu, F.; Wiestler, O.; Wesseling, P.

    2014-01-01

    Major discoveries in the biology of nervous system tumors have raised the question of how non-histological data such as molecular information can be incorporated into the next World Health Organization (WHO) classification of central nervous system tumors. To address this question, a meeting of

  15. A vegetation classification system for use in California: its conceptual basis

    Science.gov (United States)

    Timothy E. Paysen; Jeanine A. Derby; C. Eugene Conrad

    1982-01-01

    A taxonomic Vegetation Classification System proposed for use in California is designed to simplify interdisciplinary communication about vegetation. The system structure is an aggregative plant community hierarchy at four levels of precision--the Association, Series, Subformation, and Formation. A flexible Phase category links specific resource management concerns to...

  16. The Subaxial Cervical Spine Injury Classification System: an external agreement validation study

    NARCIS (Netherlands)

    Middendorp, J.J. van; Audige, L.; Bartels, R.H.M.A.; Bolger, C.; Deverall, H.; Dhoke, P.; Diekerhof, C.H.; Govaert, G.A.; Guimera, V.; Koller, H.; Morris, S.A.; Setiobudi, T.; Hosman, A.J.F.

    2013-01-01

    BACKGROUND CONTEXT: In 2007, the Subaxial Cervical Spine Injury Classification (SLIC) system was introduced demonstrating moderate reliability in an internal validation study. PURPOSE: To assess the agreement on the SLIC system using clinical data from a spinal trauma population and whether the SLIC

  17. The Subaxial Cervical Spine Injury Classification System : an external agreement validation study

    NARCIS (Netherlands)

    van Middendorp, Joost J.; Audige, Laurent; Bartels, Ronald H.; Bolger, Ciaran; Deverall, Hamish; Dhoke, Priyesh; Diekerhof, Carel H.; Govaert, Geertje A. M.; Guimera, Vicente; Koller, Heiko; Morris, Stephen A. C.; Setiobudi, Tony; Hosman, Allard J. F.

    BACKGROUND CONTEXT: In 2007, the Subaxial Cervical Spine Injury Classification (SLIC) system was introduced demonstrating moderate reliability in an internal validation study. PURPOSE: To assess the agreement on the SLIC system using clinical data from a spinal trauma population and whether the SLIC

  18. Characteristics of a global classification system for perinatal deaths : a Delphi consensus study

    NARCIS (Netherlands)

    Wojcieszek, Aleena M.; Reinebrant, Hanna E.; Leisher, Susannah Hopkins; Allanson, Emma; Coory, Michael; Erwich, Jan Jaap; Froen, J. Frederik; Gardosi, Jason; Gordijn, Sanne; Gulmezoglu, Metin; Heazell, Alexander E. P.; Korteweg, Fleurisca J.; McClure, Elizabeth; Pattinson, Robert; Silver, Robert M.; Smith, Gordon; Teoh, Zheyi; Tuncalp, Ozge; Flenady, Vicki

    2016-01-01

    Background: Despite the global burden of perinatal deaths, there is currently no single, globally-acceptable classification system for perinatal deaths. Instead, multiple, disparate systems are in use world-wide. This inconsistency hinders accurate estimates of causes of death and impedes effective

  19. Dengue disease severity in Indonesian children: An evaluation of the World Health Organization classification system

    NARCIS (Netherlands)

    T.E. Setiati (Tatty); A.T.A. Mairuhu; P. Koraka (Penelope); M. Supriatna (Mohamad); M.R. Mac Gillavry (Melvin); D.P.M. Brandjes (Dees); A.D.M.E. Osterhaus (Albert); J.W.M. van der Meer (Jos); E.C.M. van Gorp (Eric); A. Soemantri (Augustinus)

    2007-01-01

    textabstractBackground: Dengue disease severity is usually classified using criteria set up by the World Health Organization (WHO). We aimed to assess the diagnostic accuracy of the WHO classification system and modifications to this system, and evaluated their potential practical usefulness.

  20. Rock mass classification system : transition from RMR to GSI.

    Science.gov (United States)

    2013-11-01

    The AASHTO LRFD Bridge Design Specifications is expected to replace the rock mass rating : (RMR) system with the Geological Strength Index (GSI) system for classifying and estimating : engineering properties of rock masses. This transition is motivat...

  1. Recognizing systemic sclerosis: comparative analysis of various sets of classification criteria.

    Science.gov (United States)

    Romanowska-Próchnicka, Katarzyna; Walczyk, Marcela; Olesińska, Marzena

    2016-01-01

    Systemic sclerosis is a complex disease characterized by autoimmunity, vasculopathy and tissue fibrosis. Although most patients present with some degree of skin sclerosis, which is a distinguishing hallmark, the clinical presentation vary greatly complicating the diagnosis. In this regard, new classification criteria were jointly published in 2013 by American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR). A recent major development in the classification criteria is improved sensitivity, particularly for detecting early disease. The new criteria allow more cases to be classified as having systemic sclerosis (SSc), which leads to earlier treatment. Moreover it is clinically beneficial in preventing the disease progression with its irreversible fibrosis and organ damage. The aim of this review is to give insight into new classification criteria and current trends in the diagnosis of systemic sclerosis.

  2. Improved Management of Part Safety Classification System for Nuclear Power Plant

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jin Young; Park, Youn Won; Park, Heung Gyu; Park, Hyo Chan [BEES Inc., Daejeon (Korea, Republic of)

    2016-10-15

    As, in recent years, many quality assurance (QA) related incidents, such as falsely-certified parts and forged documentation, etc., were reported in association with the supply of structures, systems, components and parts to nuclear power plants, a need for a better management of safety classification system was addressed so that it would be based more on the level of parts . Presently, the Korean nuclear power plants do not develop and apply relevant procedures for safety classifications, but rather the safety classes of parts are determined solely based on the experience of equipment designers. So proposed in this paper is a better management plan for safety equipment classification system with an aim to strengthen the quality management for parts. The plan was developed through the analysis of newly introduced technical criteria to be applied to parts of nuclear power plant.

  3. Real-time expert system and neural network for the classification of remotely sensed data

    Science.gov (United States)

    Short, Nicholas, Jr.

    1991-01-01

    The paper examines software techniques for classifying remotely sensed data such that the number of computational steps and the amount of resources are bounded. The combination of both neural network and expert system methodology for classifying these data based on land use/land cover categories is examined. The method involves pipelining images through a neural net for initial classification and then through the expert system which resolves the ambiguous classifications. As with any pipeline, every component must have approximately equivalent run-times or otherwise a bottleneck will occur. If real-time is a requirement, each of the components must execute within a bounded number of steps. Attention is focused on the real-time system technique, which is argued to prevent a bottleneck for this data classification application.

  4. Classification of EEG Signals by Radial Neuro-Fuzzy Systems

    Czech Academy of Sciences Publication Activity Database

    Coufal, David

    2006-01-01

    Roč. 5, č. 2 (2006), s. 415-423 ISSN 1109-2777 R&D Projects: GA MŠk ME 701 Institutional research plan: CEZ:AV0Z10300504 Keywords : neuro-fuzzy systems * radial fuzzy systems * data mining * hybrid systems Subject RIV: BA - General Mathematics

  5. Fuzzy Rule-Based Classification System for Assessing Coronary Artery Disease.

    Science.gov (United States)

    Mohammadpour, Reza Ali; Abedi, Seyed Mohammad; Bagheri, Somayeh; Ghaemian, Ali

    2015-01-01

    The aim of this study was to determine the accuracy of fuzzy rule-based classification that could noninvasively predict CAD based on myocardial perfusion scan test and clinical-epidemiological variables. This was a cross-sectional study in which the characteristics, the results of myocardial perfusion scan (MPS), and coronary artery angiography of 115 patients, 62 (53.9%) males, in Mazandaran Heart Center in the north of Iran have been collected. We used membership functions for medical variables by reviewing the related literature. To improve the classification performance, we used Ishibuchi et al. and Nozaki et al. methods by adjusting the grade of certainty CF j of each rule. This system includes 144 rules and the antecedent part of all rules has more than one part. The coronary artery disease data used in this paper contained 115 samples. The data was classified into four classes, namely, classes 1 (normal), 2 (stenosis in one single vessel), 3 (stenosis in two vessels), and 4 (stenosis in three vessels) which had 39, 35, 17, and 24 subjects, respectively. The accuracy in the fuzzy classification based on if-then rule was 92.8 percent if classification result was considered based on rule selection by expert, while it was 91.9 when classification result was obtained according to the equation. To increase the classification rate, we deleted the extra rules to reduce the fuzzy rules after introducing the membership functions.

  6. Classification systems of communication for use in epidemiological surveillance of children with cerebral palsy.

    Science.gov (United States)

    Virella, Daniel; Pennington, Lindsay; Andersen, Guro L; Andrada, Maria da Graça; Greitane, Andra; Himmelmann, Kate; Prasauskiene, Audrone; Rackauskaite, Gija; De La Cruz, Javier; Colver, Allan

    2016-03-01

    Children with cerebral palsy (CP) often experience communication difficulties. We aimed to identify a classification system for communication of children with CP suitable for epidemiological surveillance. Systems to classify the communication of children with CP were identified. The Communication Function Classification System (CFCS), Functional Communication Classification System (FCCS), and Viking Speech Scale (VSS) were chosen for further investigation and translated. They were administered to 155 children aged 4 to 13 years with CP (across all motor severity levels) from eight European countries. Children's parents/carers, speech therapists, and other health professionals applied the systems through direct observation. Other professionals applied them from case notes only. The systems were assessed for agreement, stability, ease, and feasibility of application. Test-retest stability was moderate-to-high for VSS (k=0.66-0.88), CFCS (k=uncomputed-0.91), and FCCS (k=0.52-0.91). Overall interrater agreement was fair to very good for every classification system. VSS achieved the best agreement between parents/carers and speech therapists. VSS was considered the easiest instrument to apply. Because of its ease of use by a range of healthcare professionals, the VSS should be considered for CP registers which intend to survey speech intelligibility. For a wider assessment of communication, the CFCS or FCC should be considered. © 2015 Mac Keith Press.

  7. Data Processing And Machine Learning Methods For Multi-Modal Operator State Classification Systems

    Science.gov (United States)

    Hearn, Tristan A.

    2015-01-01

    This document is intended as an introduction to a set of common signal processing learning methods that may be used in the software portion of a functional crew state monitoring system. This includes overviews of both the theory of the methods involved, as well as examples of implementation. Practical considerations are discussed for implementing modular, flexible, and scalable processing and classification software for a multi-modal, multi-channel monitoring system. Example source code is also given for all of the discussed processing and classification methods.

  8. Comparison and classification of all-optical CDMA systems for future telecommunication networks

    Science.gov (United States)

    Iversen, Kay; Hampicke, Dirk

    1995-12-01

    This paper shows the state of the art in fiber optical code-division multiple-access (CDMA). Recent work in this area for both, systems and sequences is reviewed and analyzed. For that purpose a classification of systems, corresponding to the manner of signal processing and a classification of known (0,1)-sequences are presented. It is shown that due to the limits by currently available device technology especially two techniques are promising for implementation in broadband telecommunication networks: spectral encoding with integrated optical filters and CDMA in combination with wavelength multiple access schemes. Further an overview about some important experiments in this field is given.

  9. Gender and classifiers in concurrent systems: Refining the typology of nominal classification

    Directory of Open Access Journals (Sweden)

    Sebastian Fedden

    2017-04-01

    Full Text Available Some languages have both gender and classifiers, contrary to what was once believed possible. We use these interesting languages as a unique window onto nominal classification. They provide the impetus for a new typology, based on the degree of orthogonality of the semantic systems and the degree of difference of the forms realizing them. This nine-way typology integrates traditional gender, traditional classifiers and – importantly – the many recently attested phenomena lying between. Besides progress specifically in understanding nominal classification, our approach provides clarity on the wider theoretical issue of single versus concurrent featural systems.

  10. Multiple classifier systems in texton-based approach for the classification of CT images of Lung

    DEFF Research Database (Denmark)

    Gangeh, Mehrdad J.; Sørensen, Lauge; Shaker, Saher B.

    2010-01-01

    In this paper, we propose using texton signatures based on raw pixel representation along with a parallel multiple classifier system for the classification of emphysema in computed tomography images of the lung. The multiple classifier system is composed of support vector machines on the texton...... signatures as base classifiers and combines their decisions using product rule. The proposed approach is tested on 168 annotated regions of interest consisting of normal tissue, centrilobular emphysema, and paraseptal emphysema. Textonbased approach in texture classification mainly has two parameters, i...

  11. Proposal of a classification system for opportunities to innovate in skin care products.

    Science.gov (United States)

    Souza, I D da S; Almeida, T L; Takahashi, V P

    2015-10-01

    What are the opportunities to innovate in a skin care product? There are certainly many opportunities and many technologies involved. In this work, we assumed the role of identifying and categorizing these opportunities to develop a comprehensive and intelligible classification system, which could be used as a tool to support decision-making in different professional contexts. Initially, we employed the Delphi method to identify, discuss and standardize the opportunities to innovate in a skin care product. Finally, we used the classification system obtained in the previous phase to label patent applications, therefore, testing the suitability and utility of the system. At the end of the process, we achieved a 10-category classification system for opportunities to innovate in skin care products, and we also illustrated how this system could be used. The resultant classification system offers a normalized terminology for cosmetic scientists interested in dealing with the particularities of incremental and radical innovations in skin care products. © 2015 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

  12. Why Build Dewey Numbers? The Remediation of the Dewey Decimal Classification System

    Directory of Open Access Journals (Sweden)

    Tore Brattli

    2012-10-01

    Full Text Available Correct Dewey classification is demanding and time consuming. Many of the challenges with the Dewey system are related to locating and interpreting notes (i.e. classification guidelines, and number building. Today’s Dewey structure is a result of more than 100 years of optimizing a comprehensive classification system to the printed book medium. In order to limit the system into a “manageable” size, facets and facet-like subjects are represented only once and instead referred to from relevant classes for number building. A similar technique is used to reduce the number of notes. With the remediation of Dewey from printed to computer media, space is not limited and there is no need to compress the classification system. Number building can be eliminated, and all relevant notes attached to each class. Despite the fact that the system now has been available in electronic form for almost 20 years, it is still largely a copy of the printed version. This article first investigates how the Dewey system may be presented for users without number building, in order to make it more immediate and user-friendly. We first analyze the Dewey structure, and then look at different representations of the structure suited for computer media. Finally, some ideas for a new presentation without number building are proposed.

  13. Evolution and classification of the CRISPR-Cas systems

    NARCIS (Netherlands)

    Makarova, K.S.; Brouns, S.J.J.; Oost, van der J.

    2011-01-01

    The CRISPR-Cas (clustered regularly interspaced short palindromic repeats-CRISPR-associated proteins) modules are adaptive immunity systems that are present in many archaea and bacteria. These defence systems are encoded by operons that have an extraordinarily diverse architecture and a high rate of

  14. Sensor network based vehicle classification and license plate identification system

    Energy Technology Data Exchange (ETDEWEB)

    Frigo, Janette Rose [Los Alamos National Laboratory; Brennan, Sean M [Los Alamos National Laboratory; Rosten, Edward J [Los Alamos National Laboratory; Raby, Eric Y [Los Alamos National Laboratory; Kulathumani, Vinod K [WEST VIRGINIA UNIV.

    2009-01-01

    Typically, for energy efficiency and scalability purposes, sensor networks have been used in the context of environmental and traffic monitoring applications in which operations at the sensor level are not computationally intensive. But increasingly, sensor network applications require data and compute intensive sensors such video cameras and microphones. In this paper, we describe the design and implementation of two such systems: a vehicle classifier based on acoustic signals and a license plate identification system using a camera. The systems are implemented in an energy-efficient manner to the extent possible using commercially available hardware, the Mica motes and the Stargate platform. Our experience in designing these systems leads us to consider an alternate more flexible, modular, low-power mote architecture that uses a combination of FPGAs, specialized embedded processing units and sensor data acquisition systems.

  15. COMBINED SYSTEMS OF ENERGY GENERATION – A CHARACTERISATION AND CLASSIFICATION

    Directory of Open Access Journals (Sweden)

    Jan Gilewski

    2014-09-01

    Full Text Available The study presents issues concerning technical solutions of combined systems of energy generation which can be used primarily in low-level power plants, installed in various types of public utility sites. A detailed description is given of selected ways of powering combined energy generation systems, presenting conceptual outlines of their operation and information on their advantages, disadvantages and applications. The following systems are introduced: gas-steam, back-pressure steam turbine, extraction-condensing steam turbine, gas turbine, gas microturbine, Stirling engine, fuel cells and internal combustion piston engine. Moreover, the study addresses economic aspects of energy generation in combined systems, discussing different methodologies of cost calculation, including the one used by the European Union. The article also gives a detailed review of piston engine combined-system aggregates available in the Polish market. Type series of associated systems designed for low-power appliances are shown, produced by Polish and foreign companies such as Viessmann, Centrum Elektroniki Stosowanej CES, H. Cegielski – Poznań, KWE Technika Energetyczna, TEDOM Poland or the EPS System.

  16. Modeling in biopharmaceutics, pharmacokinetics, and pharmacodynamics homogeneous and heterogeneous approaches

    CERN Document Server

    Macheras, Panos

    2006-01-01

    The state of the art in Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics Modeling is presented in this book. It shows how advanced physical and mathematical methods can expand classical models in order to cover heterogeneous drug-biological processes and therapeutic effects in the body. The book is divided into four parts; the first deals with the fundamental principles of fractals, diffusion and nonlinear dynamics; the second with drug dissolution, release, and absorption; the third with empirical, compartmental, and stochastic pharmacokinetic models, and the fourth mainly with nonclassical aspects of pharmacodynamics. The classical models that have relevance and application to these sciences are also considered throughout. Many examples are used to illustrate the intrinsic complexity of drug administration related phenomena in the human, justifying the use of advanced modeling methods. This timely and useful book will appeal to graduate students and researchers in pharmacology, pharmaceutical scienc...

  17. Lipid-based nanocarriers for the oral administration of biopharmaceutics.

    Science.gov (United States)

    Karamanidou, Theodora; Bourganis, Vassilis; Kammona, Olga; Kiparissides, Costas

    2016-11-01

    Biopharmaceutics have been recognized as the drugs of choice for the treatment of several diseases, mainly due to their high selectivity and potent action. Nonetheless, their oral administration is a rather challenging problem, since their bioavailability is significantly hindered by various physiological barriers along the GI tract, including their acid-induced hydrolysis in the stomach, their enzymatic degradation throughout the GI tract and their poor mucosa permeability. Lipid-based nanocarriers represent a viable means for enhancing the oral bioavailability of biomolecules while diminishing toxicity-related issues. The present review describes the main physiological barriers limiting the oral bioavailability of macromolecules and highlights recent advances in the field of lipid-based carriers as well as the respective lipid intestinal absorption mechanisms.

  18. Image-based fall detection and classification of a user with a walking support system

    Science.gov (United States)

    Taghvaei, Sajjad; Kosuge, Kazuhiro

    2017-10-01

    The classification of visual human action is important in the development of systems that interact with humans. This study investigates an image-based classification of the human state while using a walking support system to improve the safety and dependability of these systems.We categorize the possible human behavior while utilizing a walker robot into eight states (i.e., sitting, standing, walking, and five falling types), and propose two different methods, namely, normal distribution and hidden Markov models (HMMs), to detect and recognize these states. The visual feature for the state classification is the centroid position of the upper body, which is extracted from the user's depth images. The first method shows that the centroid position follows a normal distribution while walking, which can be adopted to detect any non-walking state. The second method implements HMMs to detect and recognize these states. We then measure and compare the performance of both methods. The classification results are employed to control the motion of a passive-type walker (called "RT Walker") by activating its brakes in non-walking states. Thus, the system can be used for sit/stand support and fall prevention. The experiments are performed with four subjects, including an experienced physiotherapist. Results show that the algorithm can be adapted to the new user's motion pattern within 40 s, with a fall detection rate of 96.25% and state classification rate of 81.0%. The proposed method can be implemented to other abnormality detection/classification applications that employ depth image-sensing devices.

  19. British athletics muscle injury classification: a reliability study for a new grading system.

    Science.gov (United States)

    Patel, A; Chakraverty, J; Pollock, N; Chakraverty, R; Suokas, A K; James, S L

    2015-12-01

    To implement and validate the newly proposed British athletics muscle injury classification in the assessment of hamstring injuries in track and field athletes and to analyse the nature and frequency of the discrepancies. This was a retrospective study analysing hamstring injuries in elite British athletes using the proposed classification system. Classification of 65 hamstring injuries in 45 high-level athletes by two radiologists at two time points 4 months apart to determine interrater variability, intrarater variability, and feasibility of the classification system was undertaken. Interrater Kappa values of 0.80 (95% confidence interval [CI]: 0.67-0.92; p<0.0001) for Round 1 and 0.88 (95% CI: 0.76-1.00; p<0.0001) for Round 2 of the review were observed. Percentages of agreement were 85% for Round 1 and 91% for Round 2. The intrarater Kappa value for the two reviewers were 0.76 (95% CI: 0.63-0.88; p<0.0001) and 0.65 (95% CI: 0.53-0.76; p<0.0001) and the average was 0.71 suggesting substantial overall agreement. The percentages of agreement were 82% and 72%, respectively. This classification system is straightforward to use and produces both reproducible and consistent results based on interrater and intrarater Kappa values with at least substantial agreement in all groups. Further work is ongoing to investigate whether individual grades within this classification system provide prognostic information and could guide clinical management. Copyright © 2015 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

  20. The Influence of Spine Surgeons' Experience on the Classification and Intraobserver Reliability of the Novel AOSpine Thoracolumbar Spine Injury Classification System-An International Study.

    Science.gov (United States)

    Sadiqi, Said; Oner, F Cumhur; Dvorak, Marcel F; Aarabi, Bizhan; Schroeder, Gregory D; Vaccaro, Alexander R

    2015-12-01

    International validation study. To investigate the influence of the spine surgeons' level of experience on the intraobserver reliability of the novel AOSpine Thoracolumbar Spine Injury Classification system, and the appropriate classification according to this system. Wide variability has been demonstrated for intraobserver reliability of the AOSpine classification system. The spine surgeons' level of experience may play a crucial role in the appropriate classification of thoracolumbar fractures, and the degree of reproducibility of the same observer on separate occasions. However, this has not been previously investigated. After a training on the classification system, high quality CT images together with clinical data from 25 patients with thoracolumbar fractures were independently assessed by 100 spine surgeons from across the world on 2 different occasions, 1 month apart from each other. The spine surgeons were allocated to a subgroup, according to their years of experience. Intraobserver reliability was calculated for each individual surgeon and for each subgroup, using the Kappa statistics (κ). Descriptive statistics was used to describe any differences between the subgroups. Analysis of any misclassifications was performed by calculating sensitivity and specificity estimates. Almost all surgeons demonstrated at least moderate intraobserver reliability. All surgeon subgroups demonstrated substantial reliability (κ = 0.67-0.69) for fracture subtype grading, and almost all subgroups demonstrated excellent reliability (κ = 0.79-0.83) for fracture morphology type regardless of subtype identified. In general, the fractures were most frequently misclassified by the most experienced surgeons. No major differences were observed among the subgroups when comparing the sensitivity and specificity rates. This international study demonstrated that the spine surgeons' level of experience does not substantially influence the classification and intraobserver

  1. The application of rock mass classification systems to limestone mine in Korea

    Science.gov (United States)

    Kim, G.; Baek, H.; Kim, D.; Kang, S.; Kang, J.

    2011-12-01

    Rock mass classification procedure is an important part in solving most rock engineering problem. Well known rock mass classification systems include the rock mass rating (RMR) and the Q-system. These systems have been applied for various works, mostly in civil engineering applications rather than mining purposes. To assess the stability of the mine openings in underground limestone mines, RMR and Q values were estimated from 142 locations of 7 underground mine sites in Korea. Unsupported span derived from the estimated RMR and Q values were compared to measured mine opening span. The results showed that the span derived from RMR was more conservative than those from Q values. This difference might have been resulted from different parameters which each classification system uses, and also their sensitivity to the rock behaviors. Although the both rock mass classification systems have been modified and improved continuously, the results vary with site conditions. The critical span curves proposed by Lang(2001), often called as the Mathews' stability graph method, are used to calculate the unsupported span. These curves were modified for underground limestone mines in Korea. It has led to a reasonable conclusion for assessing the stability of wide underground openings in six limestone mines. Nevertheless, additional research seems to be necessary for other mine sites. The database should be required for calculating the unsupported span. To obtain more data, in ten mine sites the survey was conducted. It will be contributed to Limestone Mine Site Characterization Model(LSCM) for Korea.

  2. Arrhythmia Classification Based on Multi-Domain Feature Extraction for an ECG Recognition System.

    Science.gov (United States)

    Li, Hongqiang; Yuan, Danyang; Wang, Youxi; Cui, Dianyin; Cao, Lu

    2016-10-20

    Automatic recognition of arrhythmias is particularly important in the diagnosis of heart diseases. This study presents an electrocardiogram (ECG) recognition system based on multi-domain feature extraction to classify ECG beats. An improved wavelet threshold method for ECG signal pre-processing is applied to remove noise interference. A novel multi-domain feature extraction method is proposed; this method employs kernel-independent component analysis in nonlinear feature extraction and uses discrete wavelet transform to extract frequency domain features. The proposed system utilises a support vector machine classifier optimized with a genetic algorithm to recognize different types of heartbeats. An ECG acquisition experimental platform, in which ECG beats are collected as ECG data for classification, is constructed to demonstrate the effectiveness of the system in ECG beat classification. The presented system, when applied to the MIT-BIH arrhythmia database, achieves a high classification accuracy of 98.8%. Experimental results based on the ECG acquisition experimental platform show that the system obtains a satisfactory classification accuracy of 97.3% and is able to classify ECG beats efficiently for the automatic identification of cardiac arrhythmias.

  3. Method and System for Controlling a Dexterous Robot Execution Sequence Using State Classification

    Science.gov (United States)

    Sanders, Adam M. (Inventor); Platt, Robert J., Jr. (Inventor); Quillin, Nathaniel (Inventor); Permenter, Frank Noble (Inventor); Pfeiffer, Joseph (Inventor)

    2014-01-01

    A robotic system includes a dexterous robot and a controller. The robot includes a plurality of robotic joints, actuators for moving the joints, and sensors for measuring a characteristic of the joints, and for transmitting the characteristics as sensor signals. The controller receives the sensor signals, and is configured for executing instructions from memory, classifying the sensor signals into distinct classes via the state classification module, monitoring a system state of the robot using the classes, and controlling the robot in the execution of alternative work tasks based on the system state. A method for controlling the robot in the above system includes receiving the signals via the controller, classifying the signals using the state classification module, monitoring the present system state of the robot using the classes, and controlling the robot in the execution of alternative work tasks based on the present system state.

  4. A Modified Coal Mine Roof Rating Classification System to Design Support Requirements in Coal Mines

    Science.gov (United States)

    Taheri, Abbas; Lee, Yongha; Medina, Mario Andres Guardado

    2017-10-01

    The coal mine roof rating (CMRR) classification system has been applied in a number of coal mines worldwide including Australia. However, the current system cannot be used directly to design support measures in underground mines. Two case studies, the Eliza Hill project in Australia and Tabas coal mine in Iran were analyzed to assess the impact of various rock properties and gallery geometry on stability and to modify the CMRR classification system. Having considered the CMRR system as a working classification system, applicable information and related coal mine data were selected from the two case records. The CMRR value was evaluated and analysed by undertaking correlation between CMRR and factor of safety, followed by a parametric study based on various rock properties and gallery geometries. To improve the applicability of the current system, the CMRR system was then modified by adding additional parameters, namely, the width of roof span and the density of overburden rock. Consequently, based on the modified CMRR system (mCMRR) roof support requirements were recommended to select the suitable rock bolting system including length and spacing of rock bolt. Numerical modelling were then undertaken to verify the support requirements recommended. The support requirements recommended by the mCMRR were found to be relatively identical with numerical analysis results. Support systems proposed by mCMRR can assist mining engineers to assess the stability of underground coal mines or verify the results of other design tools.

  5. An intelligent condition monitoring system for on-line classification of machine tool wear

    Energy Technology Data Exchange (ETDEWEB)

    Fu Pan; Hope, A.D.; Javed, M. [Systems Engineering Faculty, Southampton Institute (United Kingdom)

    1997-12-31

    The development of intelligent tool condition monitoring systems is a necessary requirement for successful automation of manufacturing processes. This presentation introduces a tool wear monitoring system for milling operations. The system utilizes power, force, acoustic emission and vibration sensors to monitor tool condition comprehensively. Features relevant to tool wear are drawn from time and frequency domain signals and a fuzzy pattern recognition technique is applied to combine the multisensor information and provide reliable classification results of tool wear states. (orig.) 10 refs.

  6. An intelligent object recognizer and classification system for astronomical use

    Science.gov (United States)

    Bernat, Andrew P.; Mcgraw, John T.

    1986-01-01

    An account is given of an image-processing system based on AI concepts, which allows input images produced by the CCT/Transit Instrument to be compared with a standard-object hierarchylike network of prototypes presented within the computer as 'frames'. Each frame contains information concerning either a standard object or the links among such objects. This method, by comparison to conventional, statistically-based pattern recognition systems, classifies data as an astronomer would and thereby lends credibility to its conclusions; it also furnishes a natural avenue for the machine's serendipitous discovery of new classes of objects.

  7. Interobserver and intraobserver reliability of two classification systems for intra-articular calcaneal fractures.

    Science.gov (United States)

    Lauder, Anthony J; Inda, David J; Bott, Aaron M; Clare, Michael P; Fitzgibbons, Timothy C; Mormino, Matthew A

    2006-04-01

    For a fracture classification to be useful it must provide prognostic significance, interobserver reliability, and intraobserver reproducibility. Most studies have found reliability and reproducibility to be poor for fracture classification schemes. The purpose of this study was to evaluate the interobserver and intraobserver reliability of the Sanders and Crosby-Fitzgibbons classification systems, two commonly used methods for classifying intra-articular calcaneal fractures. Twenty-five CT scans of intra-articular calcaneal fractures occurring at one trauma center were reviewed. The CT images were presented to eight observers (two orthopaedic surgery chief residents, two foot and ankle fellows, two fellowship-trained orthopaedic trauma surgeons, and two fellowship-trained foot and ankle surgeons) on two separate occasions 8 weeks apart. On each viewing, observers were asked to classify the fractures according to both the Sanders and Crosby-Fitzgibbons systems. Interobserver reliability and intraobserver reproducibility were assessed with computer-generated kappa statistics (SAS software; SAS Institute Inc., Cary, North Carolina). Total unanimity (eight of eight observers assigned the same fracture classification) was achieved only 24% (six of 25) of the time with the Sanders system and 36% (nine of 25) of the time with the Crosby-Fitzgibbons scheme. Interobserver reliability for the Sanders classification method reached a moderate (kappa = 0.48, 0.50) level of agreement, when the subclasses were included. The agreement level increased but remained in the moderate (kappa = 0.55, 0.55) range when the subclasses were excluded. Interobserver agreement reached a substantial (kappa = 0.63, 0.63) level with the Crosby-Fitzgibbons system. Intraobserver reproducibility was better for both schemes. The Sanders system with subclasses included reached moderate (kappa = 0.57) agreement, while ignoring the subclasses brought agreement into the substantial (kappa = 0.77) range

  8. Development of a definition, classification system, and model for cultural geology

    Science.gov (United States)

    Mitchell, Lloyd W., III

    The concept for this study is based upon a personal interest by the author, an American Indian, in promoting cultural perspectives in undergraduate college teaching and learning environments. Most academicians recognize that merged fields can enhance undergraduate curricula. However, conflict may occur when instructors attempt to merge social science fields such as history or philosophy with geoscience fields such as mining and geomorphology. For example, ideologies of Earth structures derived from scientific methodologies may conflict with historical and spiritual understandings of Earth structures held by American Indians. Specifically, this study addresses the problem of how to combine cultural studies with the geosciences into a new merged academic discipline called cultural geology. This study further attempts to develop the merged field of cultural geology using an approach consisting of three research foci: a definition, a classification system, and a model. Literature reviews were conducted for all three foci. Additionally, to better understand merged fields, a literature review was conducted specifically for academic fields that merged social and physical sciences. Methodologies concentrated on the three research foci: definition, classification system, and model. The definition was derived via a two-step process. The first step, developing keyword hierarchical ranking structures, was followed by creating and analyzing semantic word meaning lists. The classification system was developed by reviewing 102 classification systems and incorporating selected components into a system framework. The cultural geology model was created also utilizing a two-step process. A literature review of scientific models was conducted. Then, the definition and classification system were incorporated into a model felt to reflect the realm of cultural geology. A course syllabus was then developed that incorporated the resulting definition, classification system, and model. This

  9. Developing and validating the Communication Function Classification System for individuals with cerebral palsy

    Science.gov (United States)

    HIDECKER, MARY JO COOLEY; PANETH, NIGEL; ROSENBAUM, PETER L; KENT, RAYMOND D; LILLIE, JANET; EULENBERG, JOHN B; CHESTER, KEN; JOHNSON, BRENDA; MICHALSEN, LAUREN; EVATT, MORGAN; TAYLOR, KARA

    2011-01-01

    Aim The purpose of this study was to create and validate a Communication Function Classification System (CFCS) for children with cerebral palsy (CP) that can be used by a wide variety of individuals who are interested in CP. This paper reports the content validity, interrater reliability, and test–retest reliability of the CFCS for children with CP. Method An 11-member development team created comprehensive descriptions of the CFCS levels, and four nominal groups comprising 27 participants critiqued these levels. Within a Delphi survey, 112 participants commented on the clarity and usefulness of the CFCS. Interrater reliability was completed by 61 professionals and 68 parents/relatives who classified 69 children with CP aged 2 to 18 years. Test–retest reliability was completed by 48 professionals who allowed at least 2 weeks between classifications. The participants who assessed the CFCS were all relevant stakeholders: adults with CP, parents of children with CP, educators, occupational therapists, physical therapists, physicians, and speech–language pathologists. Results The interrater reliability of the CFCS was 0.66 between two professionals and 0.49 between a parent and a professional. Professional interrater reliability improved to 0.77 for classification of children older than 4 years. The test–retest reliability was 0.82. Interpretation The CFCS demonstrates content validity and shows very good test–retest reliability, good professional interrater reliability, and moderate parent–professional interrater reliability. Combining the CFCS with the Gross Motor Function Classification System and the Manual Ability Classification System contributes to a functional performance view of daily life for individuals with CP, in accordance with the World Health Organization’s International Classification of Functioning, Disability and Health. PMID:21707596

  10. An evaluation of surgical site infections by wound classification system using the ACS-NSQIP.

    Science.gov (United States)

    Ortega, Gezzer; Rhee, Daniel S; Papandria, Dominic J; Yang, Jessica; Ibrahim, Andrew M; Shore, Andrew D; Makary, Martin A; Abdullah, Fizan

    2012-05-01

    Surgical wound classification has been the foundation for infectious risk assessment, perioperative protocol development, and surgical decision-making. The wound classification system categorizes all surgeries into: clean, clean/contaminated, contaminated, and dirty, with estimated postoperative rates of surgical site infection (SSI) being 1%-5%, 3%-11%, 10%-17%, and over 27%, respectively. The present study evaluates the associated rates of the SSI by wound classification using a large risk adjusted surgical patient database. A cross-sectional study was performed using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) dataset between 2005 and 2008. All surgical cases that specified a wound class were included in our analysis. Patient demographics, hospital length of stay, preoperative risk factors, co-morbidities, and complication rates were compared across the different wound class categories. Surgical site infection rates for superficial, deep incisional, and organ/space infections were analyzed among the four wound classifications using multivariate logistic regression. A total of 634,426 cases were analyzed. From this sample, 49.7% were classified as clean, 35.0% clean/contaminated, 8.56% contaminated, and 6.7% dirty. When stratifying by wound classification, the clean, clean/contaminated, contaminated, and dirty wound classifications had superficial SSI rates of 1.76%, 3.94%, 4.75%, and 5.16%, respectively. The rates of deep incisional infections were 0.54%, 0.86%, 1.31%, and 2.1%. The rates for organ/space infection were 0.28%, 1.87%, 2.55%, and 4.54%. Using ACS-NSQIP data, the present study demonstrates substantially lower rates of surgical site infections in the contaminated and dirty wound classifications than previously reported in the literature. Copyright © 2012 Elsevier Inc. All rights reserved.

  11. Intellectual Disability: Definition, Classification, and Systems of Supports. Eleventh Edition

    Science.gov (United States)

    Schalock, Robert L.; Borthwick-Duffy, Sharon A.; Bradley, Valerie J.; Buntinx, Wil H. E.; Coulter, David L.; Craig, Ellis M.; Gomez, Sharon C.; Lachapelle, Yves; Luckasson, Ruth; Reeve, Alya; Shogren, Karrie A.; Snell, Martha E.; Spreat, Scott; Tasse, Marc J.; Thompson, James R.; Verdugo-Alonso, Miguel A.; Wehmeyer, Michael L.; Yeager, Mark H.

    2010-01-01

    This Manual contains the most current and authoritative information and knowledge on intellectual disability, including best practice guidelines on diagnosing and classifying intellectual disability and developing a system of supports for people living with an intellectual disability. Written by a committee of 18 experts, "Intellectual…

  12. Performance Evaluation of Multimodal Multifeature Authentication System Using KNN Classification

    Directory of Open Access Journals (Sweden)

    Gayathri Rajagopal

    2015-01-01

    Full Text Available This research proposes a multimodal multifeature biometric system for human recognition using two traits, that is, palmprint and iris. The purpose of this research is to analyse integration of multimodal and multifeature biometric system using feature level fusion to achieve better performance. The main aim of the proposed system is to increase the recognition accuracy using feature level fusion. The features at the feature level fusion are raw biometric data which contains rich information when compared to decision and matching score level fusion. Hence information fused at the feature level is expected to obtain improved recognition accuracy. However, information fused at feature level has the problem of curse in dimensionality; here PCA (principal component analysis is used to diminish the dimensionality of the feature sets as they are high dimensional. The proposed multimodal results were compared with other multimodal and monomodal approaches. Out of these comparisons, the multimodal multifeature palmprint iris fusion offers significant improvements in the accuracy of the suggested multimodal biometric system. The proposed algorithm is tested using created virtual multimodal database using UPOL iris database and PolyU palmprint database.

  13. An updated evolutionary classification of CRISPR-Cas systems

    NARCIS (Netherlands)

    Makarova, K.S.; Wolf, Y.I.; Alkhnbashi, O.S.; Brouns, S.J.J.; Oost, Van Der John

    2015-01-01

    The evolution of CRISPR-cas loci, which encode adaptive immune systems in archaea and bacteria, involves rapid changes, in particular numerous rearrangements of the locus architecture and horizontal transfer of complete loci or individual modules. These dynamics complicate straightforward

  14. An intelligent temporal pattern classification system using fuzzy ...

    Indian Academy of Sciences (India)

    Max neural network based classifier, and then PSO rule extractor is used to minimize the number of features in the extracted rules. We empirically evaluated the effectiveness of the proposed TFMM-PSO system using the UCI Machine Learning ...

  15. Performance Evaluation of Multimodal Multifeature Authentication System Using KNN Classification.

    Science.gov (United States)

    Rajagopal, Gayathri; Palaniswamy, Ramamoorthy

    2015-01-01

    This research proposes a multimodal multifeature biometric system for human recognition using two traits, that is, palmprint and iris. The purpose of this research is to analyse integration of multimodal and multifeature biometric system using feature level fusion to achieve better performance. The main aim of the proposed system is to increase the recognition accuracy using feature level fusion. The features at the feature level fusion are raw biometric data which contains rich information when compared to decision and matching score level fusion. Hence information fused at the feature level is expected to obtain improved recognition accuracy. However, information fused at feature level has the problem of curse in dimensionality; here PCA (principal component analysis) is used to diminish the dimensionality of the feature sets as they are high dimensional. The proposed multimodal results were compared with other multimodal and monomodal approaches. Out of these comparisons, the multimodal multifeature palmprint iris fusion offers significant improvements in the accuracy of the suggested multimodal biometric system. The proposed algorithm is tested using created virtual multimodal database using UPOL iris database and PolyU palmprint database.

  16. A classification framework for clinical information system implementation in hospitals.

    NARCIS (Netherlands)

    Meulendijks, A.; Batenburg, R.; Wetering, R. van de

    2012-01-01

    In the last decade, many information system (IS) implementations took place in the healthcare organisations. Mainstream reasons for this evolvement are the increase of quality and safety of care, and reducing costs. As in many other sectors IS implementations in healthcare are complex, and

  17. Genetic Programming Based Ensemble System for Microarray Data Classification

    Directory of Open Access Journals (Sweden)

    Kun-Hong Liu

    2015-01-01

    Full Text Available Recently, more and more machine learning techniques have been applied to microarray data analysis. The aim of this study is to propose a genetic programming (GP based new ensemble system (named GPES, which can be used to effectively classify different types of cancers. Decision trees are deployed as base classifiers in this ensemble framework with three operators: Min, Max, and Average. Each individual of the GP is an ensemble system, and they become more and more accurate in the evolutionary process. The feature selection technique and balanced subsampling technique are applied to increase the diversity in each ensemble system. The final ensemble committee is selected by a forward search algorithm, which is shown to be capable of fitting data automatically. The performance of GPES is evaluated using five binary class and six multiclass microarray datasets, and results show that the algorithm can achieve better results in most cases compared with some other ensemble systems. By using elaborate base classifiers or applying other sampling techniques, the performance of GPES may be further improved.

  18. Acoustic Resonance Spectroscopy (ARS) Munition Classification System enhancements. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Vela, O.A.; Huggard, J.C.

    1997-09-18

    Acoustic Resonance Spectroscopy (ARS) is a non-destructive evaluation technology developed at the Los Alamos National Laboratory (LANL). This technology has resulted in three generations of instrumentation, funded by the Defense Special Weapons Agency (DSWA), specifically designed for field identification of chemical weapon (CW) munitions. Each generation of ARS instrumentation was developed with a specific user in mind. The ARS1OO was built for use by the U.N. Inspection Teams going into Iraq immediately after the Persian Gulf War. The ARS200 was built for use in the US-Russia Bilateral Chemical Weapons Treaty (the primary users for this system are the US Onsite Inspection Agency (OSIA) and their Russian counterparts). The ARS300 was built with the requirements of the Organization for the Prohibition of Chemical Weapons (OPCW) in mind. Each successive system is an improved version of the previous system based on learning the weaknesses of each and, coincidentally, on the fact that more time was available to do a requirements analysis and the necessary engineering development. The ARS300 is at a level of development that warrants transferring the technology to a commercial vendor. Since LANL will supply the computer software to the selected vendor, it is possible for LANL to continue to improve the decision algorithms, add features where necessary, and adjust the user interface before the final transfer occurs. This paper describes the current system, ARS system enhancements, and software enhancements. Appendices contain the Operations Manual (software Version 3.01), and two earlier reports on enhancements.

  19. Reliability assessment of AOSpine thoracolumbar spine injury classification system and Thoracolumbar Injury Classification and Severity Score (TLICS) for thoracolumbar spine injuries: results of a multicentre study.

    Science.gov (United States)

    Kaul, Rahul; Chhabra, Harvinder Singh; Vaccaro, Alexander R; Abel, Rainer; Tuli, Sagun; Shetty, Ajoy Prasad; Das, Kali Dutta; Mohapatra, Bibhudendu; Nanda, Ankur; Sangondimath, Gururaj M; Bansal, Murari Lal; Patel, Nishit

    2017-05-01

    The aim of this multicentre study was to determine whether the recently introduced AOSpine Classification and Injury Severity System has better interrater and intrarater reliability than the already existing Thoracolumbar Injury Classification and Severity Score (TLICS) for thoracolumbar spine injuries. Clinical and radiological data of 50 consecutive patients admitted at a single centre with a diagnosis of an acute traumatic thoracolumbar spine injury were distributed to eleven attending spine surgeons from six different institutions in the form of PowerPoint presentation, who classified them according to both classifications. After time span of 6 weeks, cases were randomly rearranged and sent again to same surgeons for re-classification. Interobserver and intraobserver reliability for each component of TLICS and new AOSpine classification were evaluated using Fleiss Kappa coefficient (k value) and Spearman rank order correlation. Moderate interrater and intrarater reliability was seen for grading fracture type and integrity of posterior ligamentous complex (Fracture type: k = 0.43 ± 0.01 and 0.59 ± 0.16, respectively, PLC: k = 0.47 ± 0.01 and 0.55 ± 0.15, respectively), and fair to moderate reliability (k = 0.29 ± 0.01 interobserver and 0.44+/0.10 intraobserver, respectively) for total score according to TLICS. Moderate interrater (k = 0.59 ± 0.01) and substantial intrarater reliability (k = 0.68 ± 0.13) was seen for grading fracture type regardless of subtype according to AOSpine classification. Near perfect interrater and intrarater agreement was seen concerning neurological status for both the classification systems. Recently proposed AOSpine classification has better reliability for identifying fracture morphology than the existing TLICS. Additional studies are clearly necessary concerning the application of these classification systems across multiple physicians at different level of training and trauma centers to evaluate not

  20. The Groningen Laryngomalacia Classification System-Based on Systematic Review and Dynamic Airway Changes

    NARCIS (Netherlands)

    van der Heijden, Martijn; Dikkers, Frederik G.; Halmos, Gyorgy B.

    2015-01-01

    Objective: Laryngomalacia is the most common cause of dyspnea and stridor in newborn infants. Laryngomalacia is a dynamic change of the upper airway based on abnormally pliable supraglottic structures, which causes upper airway obstruction. In the past, different classification systems have been

  1. A classification system for one Killing vector solutions of Einstein's equations

    International Nuclear Information System (INIS)

    Hoenselaers, C.

    1978-01-01

    A double classification system for one Killing vector solutions in terms of the eigenvectors and eigenvalues of the Ricci and Bach tensor of the associated three manifold is proposed. The calculations of the Bach tensor are carried out for special cases. (author)

  2. Next Generation Nuclear Plant Structures, Systems, and Components Safety Classification White Paper

    Energy Technology Data Exchange (ETDEWEB)

    Pete Jordan

    2010-09-01

    This white paper outlines the relevant regulatory policy and guidance for a risk-informed approach for establishing the safety classification of Structures, Systems, and Components (SSCs) for the Next Generation Nuclear Plant and sets forth certain facts for review and discussion in order facilitate an effective submittal leading to an NGNP Combined Operating License application under 10 CFR 52.

  3. Soil classification and carbon storage in cacao agroforestry farming systems of Bahia, Brazil

    Science.gov (United States)

    Information concerning the classification of soils and their properties under cacao agroforestry systems of the Atlantic rain forest biome region in the Southeast of Bahia Brazil is largely unknown. Soil and climatic conditions in this region are favorable for high soil carbon storage. This study is...

  4. A method to assess obstetric outcomes using the 10-Group Classification System: a quantitative descriptive study.

    LENUS (Irish Health Repository)

    Rossen, Janne

    2017-01-01

    Internationally, the 10-Group Classification System (TGCS) has been used to report caesarean section rates, but analysis of other outcomes is also recommended. We now aim to present the TGCS as a method to assess outcomes of labour and delivery using routine collection of perinatal information.

  5. Quantifying physical characteristics of wildland fuels using the fuel characteristic classification system.

    Science.gov (United States)

    Cynthia L. Riccardi; Susan J. Prichard; David V. Sandberg; Roger D. Ottmar

    2007-01-01

    Wildland fuel characteristics are used in many applications of operational fire predictions and to understand fire effects and behaviour. Even so, there is a shortage of information on basic fuel properties and the physical characteristics of wildland fuels. The Fuel Characteristic Classification System (FCCS) builds and catalogues fuelbed descriptions based on...

  6. A multilayered approach for the analysis of perinatal mortality using different classification systems

    NARCIS (Netherlands)

    Gordijn, Sanne J.; Korteweg, Fleurisca J.; Erwich, Jan Jaap H. M.; Holm, Jozien P.; van Diem, Mariet Th.; Bergman, Klasien A.; Timmer, Albertus

    Many classification systems for perinatal mortality are available, all with their own strengths and weaknesses: none of them has been universally accepted. We present a systematic multilayered approach for the analysis of perinatal mortality based on information related to the moment of death, the

  7. FMCW radar system for detection and classification of small vessels in high sea state conditions

    NARCIS (Netherlands)

    Wasselin, J.-P.; Mazuel, S.; Itcia, E.; Huizing, A.G.; Theil, A.

    2012-01-01

    The ROCKWELL COLLINS France radar department is currently developing a FMCW radar system for the detection and the classification of small maritime targets in the frame of the SISMARIS, SARGOS & I2C projects. Several test campaigns have been conducted since 2009 to develop a sensor as well as an

  8. 76 FR 51876 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System

    Science.gov (United States)

    2011-08-19

    ... validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation; (2) Design... HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System AGENCY: Food and Drug Administration, HHS. ACTION: Final...

  9. Capacities and overlap indexes with an application in fuzzy rule-based classification systems

    Czech Academy of Sciences Publication Activity Database

    Paternain, D.; Bustince, H.; Pagola, M.; Sussner, P.; Kolesárová, A.; Mesiar, Radko

    2016-01-01

    Roč. 305, č. 1 (2016), s. 70-94 ISSN 0165-0114 Institutional support: RVO:67985556 Keywords : Capacity * Overlap index * Overlap function * Choquet integral * Fuzzy rule-based classification systems Subject RIV: BA - General Mathematics Impact factor: 2.718, year: 2016 http://library.utia.cas.cz/separaty/2016/E/mesiar-0465739.pdf

  10. Duel frequency echo data acquisition system for sea-floor classification

    Digital Repository Service at National Institute of Oceanography (India)

    Navelkar, G.S.; Desai, R.G.P.; Chakraborty, B.

    An echo data acquisition system is designed to digitize echo signal from a single beam shipboard echo-sounder for use in sea-floor classification studies using a 12 bit analog to digital (A/D) card with a maximum sampling frequency of 1 MHz. Both 33...

  11. Developing and Validating the Communication Function Classification System for Individuals with Cerebral Palsy

    Science.gov (United States)

    Hidecker, Mary Jo Cooley; Paneth, Nigel; Rosenbaum, Peter L.; Kent, Raymond D.; Lillie, Janet; Eulenberg, John B.; Chester, Ken, Jr.; Johnson, Brenda; Michalsen, Lauren; Evatt, Morgan; Taylor, Kara

    2011-01-01

    Aim: The purpose of this study was to create and validate the Communication Function Classification System (CFCS) for children with cerebral palsy (CP), for use by a wide variety of individuals who are interested in CP. This paper reports the content validity, interrater reliability, and test-retest reliability of the CFCS for children with CP.…

  12. Development of the Gross Motor Function Classification System for Cerebral Palsy

    Science.gov (United States)

    Rosenbaum, Peter L.; Palisano, Robert J.; Bartlett, Doreen J.; Galuppi, Barbara E.; Russell, Dianne J.

    2008-01-01

    The Gross Motor Function Classification System (GMFCS) for cerebral palsy has been widely used internationally for clinical, research, and administrative purposes. This paper recounts the ideas and work behind the creation of the GMFCS, reports on the lessons learned, and identifies some philosophical challenges inherent in trying to develop an…

  13. Prevalence of secondary impairments of adults with cerebral palsy according to gross motor function classification system.

    Science.gov (United States)

    Park, Eun-Young; Kim, Won-Ho

    2017-02-01

    [Purpose] This study aimed to investigate the prevalence of secondary impairments in adults with cerebral palsy. [Subjects and Methods] The study sample included 52 adults with cerebral palsy who attended a convalescent or rehabilitation center for disabled individuals or a special school for physical disabilities in South Korea. [Results] The univariate analysis showed that the Gross Motor Functional Classification System level was a significant predictor of spondylopathies, general pain, arthropathies, and motor ability loss. The prevalence of these impairments at Gross Motor Functional Classification System level I and II was low compared with the prevalence found at Gross Motor Functional Classification System level III-V. The prevalence of secondary impairments among adults with cerebral palsy at Gross Motor Functional Classification System level III-V was high: loss of motor ability, 42.3%; spondylopathies, 38.4%; general pain, 32.7%; and arthropathies, 28.8%. [Conclusion] In this study, adults with severe cerebral palsy showed a high prevalence of motor ability loss, spondylopathies, arthropathies, and pain. It is necessary to develop intervention programs to prevent secondary impairments in adults with cerebral palsy.

  14. A classification system for plasmids from Enterococci and other Gram-positive bacteria

    DEFF Research Database (Denmark)

    Jensen, Lars Bogø; Garcia-Migura, Lourdes; Valenzuela, Antonio Jesus Sanchez

    2010-01-01

    A classification system for plasmids isolated from enterococci and other Gram-positive bacteria was developed based on 111 published plasmid sequences from enterococci and other Gram-positive bacteria; mostly staphylococci. Based on PCR amplification of conserved areas of the replication initiating...

  15. Development of the standard classification system of technical information in the field of RI-biomics and its application to the web system

    International Nuclear Information System (INIS)

    Jang, Sol Ah; Kim, Joo Yeon; Park, Tai Jin

    2014-01-01

    RI-Biomics is a new concept that combines radioisotopes (RI) and Biomics. For efficient collection of information, establishment of database for technical information system and its application to the system, there is an increasing need for constructing the standard classification system of technical information by its systematical classification. In this paper, we have summarized the development process of the standard classification system of technical information in the field of RI-Biomics and its application to the system. Constructing the draft version for the standard classification system of technical information was based on that standard classification one in national science and technology in Korea. The final classification system was then derived through the reconstruction and the feedback process based on the consultation from the 7 experts. These results were applied to the database of technical information system after transforming as standard code. Thus, the standard classification system were composed of 5 large classifications and 20 small classifications, and those classification are expected to establish the foundation of information system by achieving the circular structure of collection-analysis-application of information

  16. Capillary electrophoresis – mass spectrometry using noncovalently coated capillaries for the analysis of biopharmaceuticals

    NARCIS (Netherlands)

    Haselberg, R.

    2010-01-01

    With efficient methodologies available in biotechnology today, increasing numbers of recombinantly manufactured pharmaceutical peptides and proteins are being commercialized. The assessment of biopharmaceutical quality in terms of identity, content and purity is an important issue during

  17. Technical Evaluation Report 5: Classification of DE Delivery Systems

    Directory of Open Access Journals (Sweden)

    Diane Belyk

    2002-01-01

    Full Text Available For their optimal use in distance education (DE, online educational applications need to be integrated within a comprehensive course management system (CMS. Such systems are server-based software that supports the development, delivery, administration, and evaluation of online learning environments. The selection of an appropriate CMS should be considered from the multiple perspectives of the student, the course developer, the course instructor/ tutor, the technical support staff, and the DE institution’s administration. The current evaluation of CMS packages was conducted by a team of individuals with experience and contacts in relation to each of these DE user types. The report compares a series of CMS packages in terms of their range of features, and in relation to their satisfaction of international online education standards.

  18. Features, Functions and Components of a Library Classification System in the LIS tradition for the e-Environment

    Directory of Open Access Journals (Sweden)

    Satija, M.P.

    2015-12-01

    Full Text Available This paper describes qualities of a library classification system that are commonly discussed in the LIS tradition and literature, and explains such a system’s three main functions, namely knowledge mapping, information retrieval, and shelf arrangement. In this vein, the paper states the functional requirements of bibliographic classifications, which broadly are subject collocation and facilitation of browsing the collection. It explains with details the components of a library classification system and their functions. The major components are schedules, notations, and index. It also states their distinguished features, such as generalia class, form divisions, book numbers, and devices for number synthesis which are not required in a knowledge classification. It illustrates with examples from the WebDewey good examples of added features of an online library classification system. It emphasizes that institutional backup and a revision machinery are essential for a classification to survive and remain relevant in the print and e-environment.

  19. Enhancing accuracy of mental fatigue classification using advanced computational intelligence in an electroencephalography system.

    Science.gov (United States)

    Chai, Rifai; Tran, Yvonne; Craig, Ashley; Ling, Sai Ho; Nguyen, Hung T

    2014-01-01

    A system using electroencephalography (EEG) signals could enhance the detection of mental fatigue while driving a vehicle. This paper examines the classification between fatigue and alert states using an autoregressive (AR) model-based power spectral density (PSD) as the features extraction method and fuzzy particle swarm optimization with cross mutated of artificial neural network (FPSOCM-ANN) as the classification method. Using 32-EEG channels, results indicated an improved overall specificity from 76.99% to 82.02%, an improved sensitivity from 74.92 to 78.99% and an improved accuracy from 75.95% to 80.51% when compared to previous studies. The classification using fewer EEG channels, with eleven frontal sites resulted in 77.52% for specificity, 73.78% for sensitivity and 75.65% accuracy being achieved. For ergonomic reasons, the configuration with fewer EEG channels will enhance capacity to monitor fatigue as there is less set-up time required.

  20. What should an ideal spinal injury classification system consist of? A methodological review and conceptual proposal for future classifications.

    NARCIS (Netherlands)

    Middendorp, J.J. van; Audige, L.; Hanson, B.; Chapman, J.R.; Hosman, A.J.F.

    2010-01-01

    Since Bohler published the first categorization of spinal injuries based on plain radiographic examinations in 1929, numerous classifications have been proposed. Despite all these efforts, however, only a few have been tested for reliability and validity. This methodological, conceptual review