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.

Summary of the National Institute of Child Health and Human Development-best pharmaceuticals for Children Act Pediatric Formulation Initiatives Workshop-Pediatric Biopharmaceutics Classification System Working Group.

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

2012-11-01

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 to be 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. Because there are distinct developmental differences that can alter intestinal contents, volumes, permeability, and potentially biorelevant solubilities at different ages, the PBCS Working Group focused on identifying age-specific issues that need to be considered in establishing a flexible, yet rigorous PBCS. We summarized the findings of the PBCS Working Group and provided insights into considerations required for the development of a PBCS. Through several meetings conducted both at The Eunice Kennedy Shriver National Institute of Child Health, Human Development-US Pediatric Formulation Initiative 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 need to be addressed to develop a rigorous PBCS. It was determined that for a PBCS to be truly meaningful, it needs to be broken down into several different age groups that account for developmental changes in intestinal permeability, luminal contents, and gastrointestinal (GI) transit. Several critical knowledge gaps were identified, including (1) a lack of fully understanding the ontogeny of drug metabolizing enzymes and transporters along the GI tract, in the liver, and in the kidney; (2) an incomplete understanding of age-based changes in the GI, liver, and kidney physiology; (3) a clear need to better understand

Biopharmaceutical insights of particulate emulsified systems - a prospective overview.

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Katamreddy, Jyothshna Devi; Yalavarthi, Prasanna Raju; D, Subba Rao; Battu, Sowjanya; Peesa, Jaya Preethi

2018-05-10

During the twenty-first century, drug discovery is expanding rapidly and a large number of chemical moieties are recognized. Many of them are poorly soluble and hence related biopharmaceutical constraints are to be addressed systematically. Among novel approaches to resolving biopharmaceutical issues, micro- and nano-emulsified systems serve as the best strategy for delivering both hydrophobic and hydrophilic drugs owing to their greater solubilization and transportation capabilities. Of late, the unique physical and biopharmaceutical properties of these liquid isotropic homogenous systems have gained substantive research importance. In addition nano/micro lipid systems share structural and functional similarity with that of the physiological lipids which offer better tolerance ability in the body. In this context, this article provides information on the historical emergence of particulate emulsified systems, importance and rationale of selection of carriers. It also encompasses the physicochemical principles that are responsible for the elevation of therapeutic outcomes of delivery systems. Detailed and schematic absorption of these drug delivery systems is explained here. Gastro-intestinal biochemistry necessary in the understanding of digestion process, lipolytic products formed, micellar structures, enzymes, transporters, mechanism of cell uptake involved after subsequent oral absorption are also emphasized. In addition, this article also explains disposition and pharmacokinetic properties of emulsified systems with real-time therapeutic research outcomes. The influence of biochemical compositions and biopharmaceutical principles on absorption and disposition patterns of ME/NEs was described in the article for the interest of readers and young researchers.

Role of Knowledge Management in Development and Lifecycle Management of Biopharmaceuticals.

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Rathore, Anurag S; Garcia-Aponte, Oscar Fabián; Golabgir, Aydin; Vallejo-Diaz, Bibiana Margarita; Herwig, Christoph

2017-02-01

Knowledge Management (KM) is a key enabler for achieving quality in a lifecycle approach for production of biopharmaceuticals. Due to the important role that it plays towards successful implementation of Quality by Design (QbD), an analysis of KM solutions is needed. This work provides a comprehensive review of the interface between KM and QbD-driven biopharmaceutical production systems as perceived by academic as well as industrial viewpoints. A comprehensive set of 356 publications addressing the applications of KM tools to QbD-related tasks were screened and a query to gather industrial inputs from 17 major biopharmaceutical organizations was performed. Three KM tool classes were identified as having high relevance for biopharmaceutical production systems and have been further explored: knowledge indicators, ontologies, and process modeling. A proposed categorization of 16 distinct KM tool classes allowed for the identification of holistic technologies supporting QbD. In addition, the classification allowed for addressing the disparity between industrial and academic expectations regarding the application of KM methodologies. This is a first of a kind attempt and thus we think that this paper would be of considerable interest to those in academia and industry that are engaged in accelerating development and commercialization of biopharmaceuticals.

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

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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.

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

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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 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).

Delivery Systems for Biopharmaceuticals. Part I: Nanoparticles and Microparticles.

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Silva, Ana C; Lopes, Carla M; Lobo, José M S; Amaral, Maria H

2015-01-01

Pharmaceutical biotechnology has been showing therapeutic success never achieved with conventional drug molecules. Therefore, biopharmaceutical products are currently well-established in clinic and the development of new ones is expected. These products comprise mainly therapeutic proteins, although nucleic acids and cells are also included. However, according to their sensitive molecular structures, the efficient delivery of biopharmaceuticals is challenging. Several delivery systems (e.g. microparticles and nanoparticles) composed of different materials (e.g. polymers and lipids) have been explored and demonstrated excellent outcomes, such as: high cellular transfection efficiency for nucleic acids, cell targeting, increased proteins and peptides bioavailability, improved immune response in vaccination, and viability maintenance of microencapsulated cells. Nonetheless, important issues need to be addressed before they reach clinics. For example, more in vivo studies in animals, accessing the toxicity potential and predicting in vivo failure of these delivery systems are required. This is the Part I of two review articles, which presents the state of the art of delivery systems for biopharmaceuticals. Part I deals with microparticles and polymeric and lipid nanoparticles.

Biopharmaceuticals as Challenges to the Regulatory System

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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

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

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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.

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

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...

A reaction limited in vivo dissolution model for the study of drug absorption: Towards a new paradigm for the biopharmaceutic classification of drugs.

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Macheras, Panos; Iliadis, Athanassios; Melagraki, Georgia

2018-05-30

The aim of this work is to develop a gastrointestinal (GI) drug absorption model based on a reaction limited model of dissolution and consider its impact on the biopharmaceutic classification of drugs. Estimates for the fraction of dose absorbed as a function of dose, solubility, reaction/dissolution rate constant and the stoichiometry of drug-GI fluids reaction/dissolution were derived by numerical solution of the model equations. The undissolved drug dose and the reaction/dissolution rate constant drive the dissolution rate and determine the extent of absorption when high-constant drug permeability throughout the gastrointestinal tract is assumed. Dose is an important element of drug-GI fluids reaction/dissolution while solubility exclusively acts as an upper limit for drug concentrations in the lumen. The 3D plots of fraction of dose absorbed as a function of dose and reaction/dissolution rate constant for highly soluble and low soluble drugs for different "stoichiometries" (0.7, 1.0, 2.0) of the drug-reaction/dissolution with the GI fluids revealed that high extent of absorption was found assuming high drug- reaction/dissolution rate constant and high drug solubility. The model equations were used to simulate in vivo supersaturation and precipitation phenomena. The model developed provides the theoretical basis for the interpretation of the extent of drug's absorption on the basis of the parameters associated with the drug-GI fluids reaction/dissolution. A new paradigm emerges for the biopharmaceutic classification of drugs, namely, a model independent biopharmaceutic classification scheme of four drug categories based on either the fulfillment or not of the current dissolution criteria and the high or low % drug metabolism. Copyright © 2018. Published by Elsevier B.V.

Delivery systems for biopharmaceuticals. Part II: Liposomes, Micelles, Microemulsions and Dendrimers.

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Silva, Ana C; Lopes, Carla M; Lobo, José M S; Amaral, Maria H

2015-01-01

Biopharmaceuticals are a generation of drugs that include peptides, proteins, nucleic acids and cell products. According to their particular molecular characteristics (e.g. high molecular size, susceptibility to enzymatic activity), these products present some limitations for administration and usually parenteral routes are the only option. To avoid these limitations, different colloidal carriers (e.g. liposomes, micelles, microemulsions and dendrimers) have been proposed to improve biopharmaceuticals delivery. Liposomes are promising drug delivery systems, despite some limitations have been reported (e.g. in vivo failure, poor long-term stability and low transfection efficiency), and only a limited number of formulations have reached the market. Micelles and microemulsions require more studies to exclude some of the observed drawbacks and guarantee their potential for use in clinic. According to their peculiar structures, dendrimers have been showing good results for nucleic acids delivery and a great development of these systems during next years is expected. This is the Part II of two review articles, which provides the state of the art of biopharmaceuticals delivery systems. Part II deals with liposomes, micelles, microemulsions and dendrimers.

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

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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.

Modeling in biopharmaceutics, pharmacokinetics and pharmacodynamics homogeneous and heterogeneous approaches

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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...

Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets.

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Vaithianathan, Soundarya; Raman, Siddarth; Jiang, Wenlei; Ting, Tricia Y; Kane, Maureen A; Polli, James E

2015-07-06

The therapeutic equivalence of generic and brand name antiepileptic drugs has been questioned by neurologists and the epilepsy community. A potential contributor to such concerns is pharmaceutical quality. The objective was to assess the biopharmaceutic risk of brand name Lamictal 100 mg tablets and generic lamotrigine 100 mg tablets from several manufacturers. Lamotrigine was characterized in terms of the Biopharmaceutics Classification System (BCS), including aqueous solubility and Caco-2 permeability. A panel of pharmaceutical quality tests was also performed on three batches of Lamictal, three batches of Teva generic, and one batch of each of four other generics: appearance, identity, assay, impurity, uniformity of dosage units, disintegration, dissolution, friability, and loss on drying. These market surveillance results indicate that all brand name and generic lamotrigine 100 mg tablets passed all tests and showed acceptable pharmaceutical quality and low biopharmaceutic risk. Lamotrigine was classified as a BCS class IIb drug, exhibiting pH-dependent aqueous solubility and dissolution. At pH 1.2 and 4.5, lamotrigine exhibited high solubility, whereas lamotrigine exhibited low solubility at pH 6.8, including non-sink dissolution. Lamotrigine showed high Caco-2 permeability. The apparent permeability (Papp) of lamotrigine was (73.7 ± 8.7) × 10(-6) cm/s in the apical-to-basolateral (AP-BL) direction and (41.4 ± 1.6) × 10(-6) cm/s in the BL-AP direction, which were higher than metoprolol's AP-BL Papp of (21.2 ± 0.9) × 10(-6) cm/s and BL-AP Papp of (34.6 ± 4.6) × 10(-6) cm/s. Overall, lamotrigine's favorable biopharmaceutics from a drug substance perspective and favorable quality characteristics from a tablet formulation perspective suggest that multisource lamotrigine tablets exhibit a low biopharmaceutic risk.

Just how good an investment is the biopharmaceutical sector?

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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.

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.

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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.

Acceptability and characteristics of 124 human bioequivalence studies with active substances classified according to the Biopharmaceutic Classification System

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Ramirez, Elena; Laosa, Olga; Guerra, Pedro; Duque, Blanca; Mosquera, Beatriz; Borobia, Alberto M; Lei, Suhua H; Carcas, Antonio J; Frias, Jesus

2010-01-01

AIM The aim of this study was to evaluate the acceptability of 124 bioequivalence (BE) studies with 80 active substances categorized according to the Biopharmaceutics Classification System (BCS) in order to establish if there were different probabilities of proving BE between the different BCS classes. METHODS We evaluated the differences between pharmaceutical products with active substances from different BCS classes in terms of acceptability, number of subjects in the study (n), the point estimates, and intra- and inter-subject coefficients of variation data from BE studies with generic products. RESULTS Out of 124 BE studies 89 (71.77%) were performed with pharmaceutical products containing active substances classified by the BCS. In all BCS classes there were non-bioequivalent pharmaceutical products: 4 out of 26 (15.38%) in class 1, 14 out of 28 (50%) in class 2, 3 out of 22 (13.63%) in class 3 and 1 out of 13 (7.69%) in class 4. When we removed those pharmaceutical products in which intra-subject variability was higher than predicted (2 in class 1 active substances, 9 in class 2 and 2 in class 3) there were still non-BE pharmaceutical products in classes 1, 2 and 3. CONCLUSIONS Comparisons between pharmaceutical products with active substances from the four BCS classes have not allowed us to define differential characteristics of each class in terms of n, inter and intra-subject variability for Cmax or AUC. Despite the usually employed test dissolution methodology proposed as quality control, pharmaceutical products with active substances from the four classes of BCS showed non-BE studies. PMID:21039763

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

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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

Solubility behavior and biopharmaceutical classification of novel high-solubility ciprofloxacin and norfloxacin pharmaceutical derivatives.

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Breda, Susana A; Jimenez-Kairuz, Alvaro F; Manzo, Ruben H; Olivera, María E

2009-04-17

The hydrochlorides of the 1:3 aluminum:norfloxacin and aluminum:ciprofloxacin complexes were characterized according to the Biopharmaceutics Classification System (BCS) premises in comparison with their parent compounds. The pH-solubility profiles of the complexes were experimentally determined at 25 and 37 degrees C in the range of pH 1-8 and compared to that of uncomplexed norfloxacin and ciprofloxacin. Both complexes are clearly more soluble than the antibiotics themselves, even at the lowest solubility pHs. The increase in solubility was ascribed to the species controlling solubility, which were analyzed in the solid phases at equilibrium at selected pHs. Additionally, permeability was set as low, based on data reported in the scientific literature regarding oral bioavailability, intestinal and cell cultures permeabilities and also considering the influence of stoichiometric amounts of aluminum. The complexes fulfill the BCS criterion to be classified as class 3 compounds (high solubility/low permeability). Instead, the active pharmaceutical ingredients (APIs) currently used in solid dosage forms, norfloxacin and ciprofloxacin hydrochloride, proved to be BCS class 4 (low solubility/low permeability). The solubility improvement turns the complexes as potential biowaiver candidates from the scientific point of view and may be a good way for developing more dose-efficient formulations. An immediate release tablet showing very rapid dissolution was obtained. Its dissolution profile was compared to that of the commercial ciprofloxacin hydrochloride tablets allowing to dissolution of the complete dose at a critical pH such as 6.8.

Risk Management in Biopharmaceutical Supply Chains

OpenAIRE

Ma, Yao

2011-01-01

Biopharmaceutical supply chains present considerable complexity issue for the formulation of optimal plans due to significant uncertainty in the supply chain. The primary goal of biopharmaceutical supply chain planning is to provide reliable supply to patients while coping with various supply chain risks. In chapter 1 first I discuss the key elements and basic characteristics of the biopharmaceutical supply chain . Then I present the major challenges in biopharmaceutical supply chain planning...

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

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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.

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

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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.

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.

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

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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

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

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...

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.

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.

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...

Health economics of market access for biopharmaceuticals and biosimilars.

Science.gov (United States)

Simoens, Steven

2009-09-01

This article discusses health economic challenges of research and development, registration, pricing and reimbursement of biopharmaceuticals and biosimilars. A literature search was carried out of PubMed, Centre for Reviews and Dissemination databases, Cochrane Database of Systematic Reviews and EconLit up to March 2009. The development process of biopharmaceuticals is risky, lengthy, complex and expensive. Registration is complicated by the inherent variation between biopharmaceuticals. Also, as biopharmaceuticals are likely to be efficacious in a subgroup of the patient population, there is a need to select the most responsive target population and to identify biomarkers. To inform pricing and reimbursement decisions, the development process needs to collect comparative data to calculate the incremental cost effectiveness and budget impact of biopharmaceuticals. There is a role for innovative mechanisms such as risk-sharing arrangements to reimburse biopharmaceuticals. Given that biosimilars are similar, but not identical to the reference biopharmaceutical, the development process needs to generate clinical trial data in order to gain marketing authorisation. From a health economic perspective, the question arises whether inherent differences between biopharmaceuticals and biosimilars produce differences in safety, effectiveness and costs: to date, this question is unresolved. The early inclusion of health economics in the process of developing biopharmaceuticals and biosimilars is imperative with a view to demonstrating their relative (cost) effectiveness and informing registration, pricing and reimbursement decisions.

The state of biopharmaceutical manufacturing.

Science.gov (United States)

Molowa, David T; Mazanet, Rosemary

2003-01-01

The manufacturing of protein-based biopharmaceuticals is done in bacterial or mammalian cell cultures. While bacterial cultures are inexpensive, dependable, and approved by regulatory authorities, many complex proteins cannot be manufactured this way. Complex proteins must be manufactured in mammalian cell cultures to produce active products. Mammalian cell culture capacity is limited and has slowed the delivery of necessary biopharmaceutical products to patients. The nature of the production capacity problem and future outlook are critically examined.

Small and Medium Enterprises and Biopharmaceutical Innovations ...

African Journals Online (AJOL)

Small and Medium Enterprises and Biopharmaceutical Innovations in Africa: ... through biotechnological processes with links to biological sources especially those of live ... There are more than 500 biopharmaceutical products that have been ... By Country · List All Titles · Free To Read Titles This Journal is Open Access.

Follow-on biologics: competition in the biopharmaceutical marketplace.

Science.gov (United States)

Devine, Joshua W; Cline, Richard R; Farley, Joel F

2006-01-01

To describe the implications of a follow-on biologic approval process with focus on current stakeholders, implications of the status quo, and recommendations for future policy. A search using Medline, International Pharmaceutical Abstracts, Med Ad News, F-D-C Reports/Pink Sheets, and Google index directories was conducted with terms such as biologic, biopharmaceutical, generic, and follow-on. Articles pertaining to the follow-on biologic debate. By the authors. Over the past decade, the biopharmaceutical market has experienced substantial growth in the number of product approvals and sales. In contrast with prescription medications, biologic agents currently lack an abbreviated regulatory approval process. Evidence from the Drug Price Competition and Patent Term Restoration Act of 1984 suggests that reducing barriers to generic competition in the pharmaceutical market successfully increases generic market penetration and reduces overall prices to consumers. Although scientific and regulatory dissimilarities between biopharmaceuticals and other medications exist, a follow-on biologic approval process has the potential to play an important role in containing growth in pharmaceutical spending. In addition to biopharmaceutical and generic biopharmaceutical manufacturers, stakeholders with a vested interest in this debate include individual consumers who continue to bear the burden of spending increases in the pharmaceutical market. The debate over a follow-on process likely will be difficult as parties seek a balance between incentives for biopharmaceutical innovation, consumer safety, and affordability of existing biologic products.

Do the recommended standards for in vitro biopharmaceutic classification of drug permeability meet the "passive transport" criterion for biowaivers?

Science.gov (United States)

Žakelj, Simon; Berginc, Katja; Roškar, Robert; Kraljič, Bor; Kristl, Albin

2013-01-01

BCS based biowaivers are recognized by major regulatory agencies. An application for a biowaiver can be supported by or even based on "in vitro" measurements of drug permeability. However, guidelines limit the application of biowaivers to drug substances that are transported only by passive mechanisms. Regarding published permeability data as well as measurements obtained in our institution, one can rarely observe drug substances that conform to this very strict criterion. Therefore, we measured the apparent permeability coefficients of 13 drugs recommended by FDA's Guidance to be used as standards for "in vitro" permeability classification. The asymmetry of permeability data determined for both directions (mucosal-to-serosal and serosalto- mucosal) through the rat small intestine revealed significant active transport for four out of the nine high-permeability standards and for all four low-permeability standard drugs. As could be expected, this asymmetry was abolished at 4°C on rat intestine. The permeability of all nine high-permeability, but none of the low permeability standards, was also much lower when measured with intestinal tissue, Caco-2 cell monolayers or artificial membranes at 4°C compared to standard conditions (37°C). Additionally, concurrent testing of several standard drugs revealed that membrane transport can be affected by the use of internal permeability standards. The implications of the results are discussed regarding the regulatory aspects of biopharmaceutical classification, good practice in drug permeability evaluation and regarding the general relevance of transport proteins with broad specificity in drug absorption.

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

Separation science is the key to successful biopharmaceuticals.

Science.gov (United States)

Guiochon, Georges; Beaver, Lois Ann

2011-12-09

The impact of economic change, advances in science, therapy and production processes resulted in considerable growth in the area of biopharmaceuticals. Progress in selection of microorganisms and improvements in cell culture and bioreactors is evidenced by increased yields of the desired products in the complex fermentation mixture. At this stage the downstream process of extraction and purification of the desired biopharmaceutical requires considerable attention in the design and operation of the units used for preparative chromatography. Understanding of the process, optimization of column design and experimental conditions have become critical to the biopharmaceutical industry in order to minimize production costs while satisfying new regulatory requirements. Optimization of the purification of biopharmaceuticals by preparative liquid chromatography including an examination of column preparation and bed properties is the focus of this manuscript. Copyright © 2011 Elsevier B.V. All rights reserved.

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

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

Delivery and Immunogenicity of Biopharmaceuticals for Vaccination or Therapy

NARCIS (Netherlands)

de Groot, A.M.

2017-01-01

Biopharmaceuticals (or biologicals) are a new class of drugs produced by the biotechnology field and offer many advantages compared to classical small molecule synthetic drugs. Biopharmaceuticals (BP) are from biological origin and may consist of proteins or peptides, nucleic acids such as RNA and

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.

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 th...

Mammalian cell culture capacity for biopharmaceutical manufacturing.

Science.gov (United States)

Ecker, Dawn M; Ransohoff, Thomas C

2014-01-01

: With worldwide sales of biopharmaceuticals increasing each year and continuing growth on the horizon, the manufacture of mammalian biopharmaceuticals has become a major global enterprise. We describe the current and future industry wide supply of manufacturing capacity with regard to capacity type, distribution, and geographic location. Bioreactor capacity and the use of single-use products for biomanufacturing are also profiled. An analysis of the use of this capacity is performed, including a discussion of current trends that will influence capacity growth, availability, and utilization in the coming years.

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.

Formulation Strategies and Particle Engineering Technologies for Pulmonary Delivery of Biopharmaceuticals

DEFF Research Database (Denmark)

Cun, Dongmei; Wan, Feng; Yang, Mingshi

2015-01-01

. 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....

The Research on International Development Path of China’s Marine Biopharmaceutical Industry

Directory of Open Access Journals (Sweden)

Xiu-Mei Fu

2018-02-01

Full Text Available Under the backdrop of the Maritime Silk Road Initiative, the study on the international development of China’s marine biopharmaceutical industry based on factor allocation is of great practical significance for industrial sustainability and building the industry into a leading international player in the global market. In this paper, we first identify the leading factors that influence the development of the marine biopharmaceutical industry, namely, resources, technologies, talents, investments and policies. Furthermore, the hierarchical structure model of these factors was established and analyzed using the analytic hierarchy process (AHP. The importance ranking of these constraints was identified, as follows: technologies > talents > resources > policies > investments. Then, based on the theory of comparative advantage and game theory, we analyzed the necessity of China’s marine biopharmaceutical industry going global, that is, international cooperation may lay a solid foundation for the win-win outcome of this industry in countries along the Maritime Silk Road. According to the status quo of China’s marine biopharmaceutical industry, based on these findings, an international factor–allocation cooperation path was designed, and the path chart of the international development of the marine biopharmaceutical industry was drawn. Finally, methods for the development of China’s marine biopharmaceutical industry were proposed, which covers efforts to protect marine resources, promote R&D for core technologies, establish a strong talent pool, encourage more investments, provide policy support and promote worldwide cooperation. It is the first report to investigate the path of the sustainable exploitation of the marine biopharmaceutical industry from the perspective of factor allocation amidst the backdrop of the Maritime Silk Road Initiative.

Biopharmaceutical production: Applications of surface plasmon resonance biosensors.

Science.gov (United States)

Thillaivinayagalingam, Pranavan; Gommeaux, Julien; McLoughlin, Michael; Collins, David; Newcombe, Anthony R

2010-01-15

Surface plasmon resonance (SPR) permits the quantitative analysis of therapeutic antibody concentrations and impurities including bacteria, Protein A, Protein G and small molecule ligands leached from chromatography media. The use of surface plasmon resonance has gained popularity within the biopharmaceutical industry due to the automated, label free, real time interaction that may be exploited when using this method. The application areas to assess protein interactions and develop analytical methods for biopharmaceutical downstream process development, quality control, and in-process monitoring are reviewed. 2009 Elsevier B.V. All rights reserved.

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.

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, novel...

Biotechnological production of pharmaceuticals and biopharmaceuticals in plant cell and organ cultures.

Science.gov (United States)

Hidalgo, Diego; Sanchez, Raul; Lalaleo, Liliana; Bonfill, Mercedes; Corchete, Purificacion; Palazon, Javier

2018-03-09

Plant biofactories are biotechnological platforms based on plant cell and organ cultures used for the production of pharmaceuticals and biopharmaceuticals, although to date only a few of these systems have successfully been implemented at an industrial level. Metabolic engineering is possibly the most straightforward strategy to boost pharmaceutical production in plant biofactories, but social opposition to the use of GMOs means empirical approaches are still being used. Plant secondary metabolism involves thousands of different enzymes, some of which catalyze specific reactions, giving one product from a particular substrate, whereas others can yield multiple products from the same substrate. This trait opens plant cell biofactories to new applications, in which the natural metabolic machinery of plants can be harnessed for the bioconversion of phytochemicals or even the production of new bioactive compounds. Synthetic biological pipelines involving the bioconversion of natural substrates into products with a high market value may be established by the heterologous expression of target metabolic genes in model plants. To summarize the state of the art of plant biofactories and their applications for the pipeline production of cosme-, pharma- and biopharmaceuticals. In order to demonstrate the great potential of plant biofactories for multiple applications in the biotechnological production of pharmaceuticals and biopharmaceuticals, this review broadly covers the following: plant biofactories based on cell and hairy root cultures; secondary metabolite production; biotransformation reactions; metabolic engineering tools applied in plant biofactories; and biopharmaceutical production. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

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.

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.

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

2011-01-01

monitor 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

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

Guidance to Achieve Accurate Aggregate Quantitation in Biopharmaceuticals by SV-AUC.

Science.gov (United States)

Arthur, Kelly K; Kendrick, Brent S; Gabrielson, John P

2015-01-01

The levels and types of aggregates present in protein biopharmaceuticals must be assessed during all stages of product development, manufacturing, and storage of the finished product. Routine monitoring of aggregate levels in biopharmaceuticals is typically achieved by size exclusion chromatography (SEC) due to its high precision, speed, robustness, and simplicity to operate. However, SEC is error prone and requires careful method development to ensure accuracy of reported aggregate levels. Sedimentation velocity analytical ultracentrifugation (SV-AUC) is an orthogonal technique that can be used to measure protein aggregation without many of the potential inaccuracies of SEC. In this chapter, we discuss applications of SV-AUC during biopharmaceutical development and how characteristics of the technique make it better suited for some applications than others. We then discuss the elements of a comprehensive analytical control strategy for SV-AUC. Successful implementation of these analytical control elements ensures that SV-AUC provides continued value over the long time frames necessary to bring biopharmaceuticals to market. © 2015 Elsevier Inc. All rights reserved.

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.

Small and Medium Enterprises and Biopharmaceutical Innovations ...

African Journals Online (AJOL)

Erah

Benin City, 300001 Nigeria. All rights ... are challenges facing African Small and Medium Enterprises (SMEs) in biopharmaceutical industry, the ... Network for Drug and Diagnostics recognizes .... functionality is in place, integration into the.

Capacity Planning for Batch and Perfusion Bioprocesses Across Multiple Biopharmaceutical Facilities

OpenAIRE

Siganporia, Cyrus C; Ghosh, Soumitra; Daszkowski, Thomas; Papageorgiou, Lazaros G; Farid, Suzanne S

2014-01-01

Production planning for biopharmaceutical portfolios becomes more complex when products switch between fed-batch and continuous perfusion culture processes. This article describes the development of a discrete-time mixed integer linear programming (MILP) model to optimize capacity plans for multiple biopharmaceutical products, with either batch or perfusion bioprocesses, across multiple facilities to meet quarterly demands. The model comprised specific features to account for products with fe...

Innovator Organizations in New Drug Development: Assessing the Sustainability of the Biopharmaceutical Industry.

Science.gov (United States)

Kinch, Michael S; Moore, Ryan

2016-06-23

The way new medicines are discovered and brought to market has fundamentally changed over the last 30 years. Our previous analysis showed that biotechnology companies had contributed significantly to the US Food and Drug Administration approval of new molecular entities up to the mid-1980s, when the trends started to decline. Although intriguing, the focus on biotechnology necessarily precluded the wider question of how the biopharmaceutical industry has been delivering on its goals to develop new drugs. Here, we present a comprehensive analysis of all biopharmaceutical innovators and uncover unexpected findings. The present biopharmaceutical industry grew steadily from 1800 to 1950 and then stagnated for two decades, before a burst of growth attributable to the biotechnology revolution took place; but consolidation has reduced the number of active and independent innovators to a level not experienced since 1945. The trajectories and trends we observe raise fundamental questions about biopharmaceutical innovators and the sustainability of the drug-development enterprise. Copyright © 2016 Elsevier Ltd. All rights reserved.

Establishing the pharmaceutical quality of Chinese herbal medicine: a provisional BCS classification.

Science.gov (United States)

Fong, Sophia Y K; Liu, Mary; Wei, Hai; Löbenberg, Raimar; Kanfer, Isadore; Lee, Vincent H L; Amidon, Gordon L; Zuo, Zhong

2013-05-06

The Biopharmaceutical Classification System (BCS), which is a scientific approach to categorize active drug ingredient based on its solubility and intestinal permeability into one of the four classes, has been used to set the pharmaceutical quality standards for drug products in western society. However, it has received little attention in the area of Chinese herbal medicine (CHM). This is likely, in part, due to the presence of multiple active components as well as lack of standardization of CHM. In this report, we apply BCS classification to CHMs provisionally as a basis for establishing improved in vitro quality standards. Based on a top-200 drugs selling list in China, a total of 31 CHM products comprising 50 official active marker compounds (AMCs) were provisionally classified according to BCS. Information on AMC content and doses of these CHM products were retrieved from the Chinese Pharmacopoeia. BCS parameters including solubility and permeability of the AMCs were predicted in silico (ACD/Laboratories). A BCS classification of CHMs according to biopharmaceutical properties of their AMCs is demonstrated to be feasible in the current study and can be used to provide a minimum set of quality standards. Our provisional results showed that 44% of the included AMCs were classified as Class III (high solubility, low permeability), followed by Class II (26%), Class I (18%), and Class IV (12%). A similar trend was observed when CHMs were classified in accordance with the BCS class of AMCs. Most (45%) of the included CHMs were classified as Class III, followed by Class II (16%), Class I (10%), and Class IV (6%); whereas 23% of the CHMs were of mixed class due to the presence of multiple individual AMCs with different BCS classifications. Moreover, about 60% of the AMCs were classified as high-solubility compounds (Class I and Class III), suggesting an important role for an in vitro dissolution test in setting quality control standards ensuring consistent

Hybrid and Disposable Facilities for Manufacturing of Biopharmaceuticals: Pros and Cons

Science.gov (United States)

Ravisé, Aline; Cameau, Emmanuelle; de Abreu, Georges; Pralong, Alain

Modern biotechnology has grown over the last 35 years to a maturing industry producing and delivering high-value biopharmaceuticals that yield important medical and economical benefits. The constantly increasing need for biopharmaceuticals and significant costs related to time-consuming R&D work makes this industry risky and highly competitive. This trend is confirmed by the important number of biopharmaceuticals that are actually under development at all stages by all major pharmaceutical industry companies. A consequence of this evolution is an increasing need for development and manufacturing capacity. The build up of traditional - stainless steel - technology is complicated, time consuming and very expensive. The decision for such a major investment needs to be taken early in the development cycle of a promising drug to cope with future demands for clinical trials and product launch. Possibilities for the reduction of R&D and manufacturing costs are therefore of significant interest in order to be competitive.

Immunogenicity of biopharmaceuticals and biosimilars in relation to storage, handling and stability

International Nuclear Information System (INIS)

Hincal, F.

2009-01-01

Therapeutic proteins or biopharmaceuticals provide effective treatment for many diseases and medical conditions, and vaccines, immunoglobulins and monoclonal antibodies are critical biodefense biopharmaceuticals which constitute an indispensable part of biodefense stockpiles. The manufacturing process for biopharmaceuticals and their generic forms which are called biosimilars is far more complex than for low molecular weight drugs and generics. Any minor change made at any stage may have a critical effect on the clinical efficacy and safety. Potential immunogenicity is the key issue for biopharmaceuticals and biosimilars and may have serious clinical consequences ranging from allergy and anaphylaxis, as well as loss of efficacy of the product. Immunogenicity may be influenced by factors related to manufacturing process, formulation, aggregate formation, contaminants and impurities, and also by the factors related to the storage and handling. Stability is particularly important with larger protein molecules, because their in vivo effects often depend on their three-dimensional structure. Proteins usually aggregate from partially unfolded molecules and aggregates can enhance immunogenicity. Although product formulations are developed to maximize and maintain the fraction of the protein molecules present in the native state, significant amounts of aggregates can form, especially over pharmaceutically relevant time scales and under stress conditions. Exposure to air-liquid and solid-liquid interfaces, light, temperature fluctuations or minor impurities can induce aggregation. Such exposure can occur during processing steps, as well as in the final product container during storage, shipment and handling. Biopharmaceuticals are particularly sensitive to temperature changes and/or shaking. Strict storage and handling conditions and timely and effective stability/shelf-life testing are therefore essential for maintaining product integrity and stability, and hence efficacy

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....

Biopharmaceutical innovation and industrial developments in South Korea, Singapore and Taiwan.

Science.gov (United States)

Hsieh, Chee-Ruey; Löfgren, Hans

2009-05-01

South Korea, Singapore and Taiwan are well known as export-oriented developmental states which for decades employed industrial policy to target particular industries for government support. In the past fifteen years, these three countries all identified the biopharmaceutical industry as a strategic sector. This article explores, through economic analysis, the rationale for this decision and the strategies chosen for linking into the global bio-economy with the objective of catching up in biopharmaceuticals. The paper identifies three comparative advantages enjoyed by these countries in the biopharma sector: (1) public investments in basic research; (2) private investments in phase 1 clinical trials; and (3) a potentially significant contract research industry managing latter-stage clinical trials. Governments employ a range of industrial policies, consistent with these comparative advantages, to promote the biopharmaceutical industry, including public investment in biomedical hubs, research funding and research and development (R&D) tax credits. We argue that the most important feature of the biopharmaceutical industry in these countries is the dominant role of the public sector. That these countries have made progress in innovative capabilities is illustrated by input measures such as R&D expenditure as share of gross domestic product, number of patents granted and clinical trials, and volume of foreign direct investment. In contrast, output indicators such as approval of new chemical entities suggest that the process of catching up has only just commenced. Pharmaceutical innovation is at the stage of mainly generating inputs to integrated processes controlled by the globally incumbent firms.

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

Protein N-glycosylation in eukaryotic microalgae and its impact on the production of nuclear expressed biopharmaceuticals

Directory of Open Access Journals (Sweden)

Elodie eMathieu-Rivet

2014-07-01

Full Text Available Microalgae are currently used for the production of food compounds. Recently, few microalgae species have been investigated as potential biofactories for the production of biopharmaceuticals. Indeed in this context, microalgae are cheap, classified as Generally Recognized As Safe (GRAS organisms and can be grown easily. However, problems remain to be solved before any industrial production of microalgae-made biopharmaceuticals. Among them, post-translational modifications of the proteins need to be considered. Especially, N-glycosylation acquired by the secreted recombinant proteins is of major concern since most of the biopharmaceuticals are N-glycosylated and it is well recognized that glycosylation represent one of their critical quality attribute. Therefore, the evaluation of microalgae as alternative cell factory for biopharmaceutical productions thus requires to investigate their N-glycosylation capability in order to determine to what extend it differs from their human counterpart and to determine appropriate strategies for remodelling the microalgae glycosylation into human-compatible oligosaccharides. Here, we review the secreted recombinant proteins which have been successfully produced in microalgae. We also report on recent bioinformatics and biochemical data concerning the structure of glycans N-linked to proteins from various microalgae phyla and comment the consequences on the glycan engineering strategies that may be necessary to render those microalgae-made biopharmaceuticals compatible with human therapy.

Examining the sources of variability in cell culture media used for biopharmaceutical production.

Science.gov (United States)

McGillicuddy, Nicola; Floris, Patrick; Albrecht, Simone; Bones, Jonathan

2018-01-01

Raw materials, in particular cell culture media, represent a significant source of variability to biopharmaceutical manufacturing processes that can detrimentally affect cellular growth, viability and specific productivity or alter the quality profile of the expressed therapeutic protein. The continual expansion of the biopharmaceutical industry is creating an increasing demand on the production and supply chain consistency for cell culture media, especially as companies embrace intensive continuous processing. Here, we provide a historical perspective regarding the transition from serum containing to serum-free media, the development of chemically-defined cell culture media for biopharmaceutical production using industrial scale bioprocesses and review production mechanisms for liquid and powder culture media. An overview and critique of analytical approaches used for the characterisation of cell culture media and the identification of root causes of variability are also provided, including in-depth liquid phase separations, mass spectrometry and spectroscopic methods.

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 (pattractiveness for biopharmaceutical industry-sponsored clinical trials.

Safe handling of cytotoxic compounds in a biopharmaceutical environment.

Science.gov (United States)

Hensgen, Miriam I; Stump, Bernhard

2013-01-01

Handling cytotoxic drugs such as antibody-drug conjugates (ADCs) in a biopharmaceutical environment represents a challenge based on the potency of the compounds. These derivatives are dangerous to humans if they accidentally get in contact with the skin, are inhaled, or are ingested, either as pure compounds in their solid state or as a solution dissolved in a co-solvent. Any contamination of people involved in the manufacturing process has to be avoided. On the other hand, biopharmaceuticals need to be protected simultaneously against any contamination from the manufacturing personnel. Therefore, a tailor-made work environment is mandatory in order to manufacture ADCs. This asks for appropriate technical equipment to keep potential hazardous substances contained. In addition, clearly defined working procedures based on risk assessments as well as proper training for all personnel involved in the manufacturing process are needed to safely handle these highly potent pharmaceuticals.

A new large-scale manufacturing platform for complex biopharmaceuticals.

Science.gov (United States)

Vogel, Jens H; Nguyen, Huong; Giovannini, Roberto; Ignowski, Jolene; Garger, Steve; Salgotra, Anil; Tom, Jennifer

2012-12-01

Complex biopharmaceuticals, such as recombinant blood coagulation factors, are addressing critical medical needs and represent a growing multibillion-dollar market. For commercial manufacturing of such, sometimes inherently unstable, molecules it is important to minimize product residence time in non-ideal milieu in order to obtain acceptable yields and consistently high product quality. Continuous perfusion cell culture allows minimization of residence time in the bioreactor, but also brings unique challenges in product recovery, which requires innovative solutions. In order to maximize yield, process efficiency, facility and equipment utilization, we have developed, scaled-up and successfully implemented a new integrated manufacturing platform in commercial scale. This platform consists of a (semi-)continuous cell separation process based on a disposable flow path and integrated with the upstream perfusion operation, followed by membrane chromatography on large-scale adsorber capsules in rapid cycling mode. Implementation of the platform at commercial scale for a new product candidate led to a yield improvement of 40% compared to the conventional process technology, while product quality has been shown to be more consistently high. Over 1,000,000 L of cell culture harvest have been processed with 100% success rate to date, demonstrating the robustness of the new platform process in GMP manufacturing. While membrane chromatography is well established for polishing in flow-through mode, this is its first commercial-scale application for bind/elute chromatography in the biopharmaceutical industry and demonstrates its potential in particular for manufacturing of potent, low-dose biopharmaceuticals. Copyright © 2012 Wiley Periodicals, Inc.

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.

Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators

Directory of Open Access Journals (Sweden)

Rezaie Rahim

2012-06-01

Full Text Available Abstract Biopharmaceutical innovation has had a profound health and economic impact globally. Developed countries have traditionally been the source of most innovations as well as the destination for the resulting economic and health benefits. As a result, most prior research on this sector has focused on developed countries. This paper seeks to fill the gap in research on emerging markets by analyzing factors that influence innovative activity in the indigenous biopharmaceutical sectors of China, India, Brazil, and South Africa. Using qualitative research methodologies, this paper a shows how biopharmaceutical innovation is taking place within the entrepreneurial sectors of these emerging markets, b identifies common challenges that indigenous entrepreneurs face, c highlights the key role played by the state, and d reveals that the transition to innovation by companies in the emerging markets is characterized by increased global integration. It suggests that biopharmaceutical innovators in emerging markets are capitalizing on opportunities to participate in the drug development value chain and thus developing capabilities and relationships for competing globally both with and against established companies headquartered in developed countries.

Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators.

Science.gov (United States)

Rezaie, Rahim; McGahan, Anita M; Frew, Sarah E; Daar, Abdallah S; Singer, Peter A

2012-06-06

Biopharmaceutical innovation has had a profound health and economic impact globally. Developed countries have traditionally been the source of most innovations as well as the destination for the resulting economic and health benefits. As a result, most prior research on this sector has focused on developed countries. This paper seeks to fill the gap in research on emerging markets by analyzing factors that influence innovative activity in the indigenous biopharmaceutical sectors of China, India, Brazil, and South Africa. Using qualitative research methodologies, this paper a) shows how biopharmaceutical innovation is taking place within the entrepreneurial sectors of these emerging markets, b) identifies common challenges that indigenous entrepreneurs face, c) highlights the key role played by the state, and d) reveals that the transition to innovation by companies in the emerging markets is characterized by increased global integration. It suggests that biopharmaceutical innovators in emerging markets are capitalizing on opportunities to participate in the drug development value chain and thus developing capabilities and relationships for competing globally both with and against established companies headquartered in developed countries.

Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool.

Science.gov (United States)

Zimmermann, Hartmut F; Hentschel, Norbert

2011-01-01

With the publication of the quality guideline ICH Q9 "Quality Risk Management" by the International Conference on Harmonization, risk management has already become a standard requirement during the life cycle of a pharmaceutical product. Failure mode and effect analysis (FMEA) is a powerful risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to biopharmaceutical processes brings about some difficulties. The proposal presented here is intended to serve as a brief but nevertheless comprehensive and detailed guideline on how to conduct a biopharmaceutical process FMEA. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. The application for such a biopharmaceutical process FMEA is widespread. It can be useful whenever a biopharmaceutical manufacturing process is developed or scaled-up, or when it is transferred to a different manufacturing site. It may also be conducted during substantial optimization of an existing process or the development of a second-generation process. According to their resulting risk ratings, process parameters can be ranked for importance and important variables for process development, characterization, or validation can be identified. Health authorities around the world ask pharmaceutical companies to manage risk during development and manufacturing of pharmaceuticals. The so-called failure mode and effect analysis (FMEA) is an established risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to pharmaceutical processes that use modern biotechnology (biopharmaceutical processes) brings about some difficulties, because those biopharmaceutical processes differ from processes in mechanical and electrical industries. The proposal presented here

Hybrid and disposable facilities for manufacturing of biopharmaceuticals: pros and cons.

Science.gov (United States)

Ravisé, Aline; Cameau, Emmanuelle; De Abreu, Georges; Pralong, Alain

2009-01-01

Modern biotechnology has grown over the last 35 years to a maturing industry producing and delivering high-value biopharmaceuticals that yield important medical and economical benefits. The constantly increasing need for biopharmaceuticals and significant costs related to time-consuming R&D work makes this industry risky and highly competitive. This trend is confirmed by the important number of biopharmaceuticals that are actually under development at all stages by all major pharmaceutical industry companies. A consequence of this evolution is an increasing need for development and manufacturing capacity. The build up of traditional - stainless steel - technology is complicated, time consuming and very expensive. The decision for such a major investment needs to be taken early in the development cycle of a promising drug to cope with future demands for clinical trials and product launch. Possibilities for the reduction of R&D and manufacturing costs are therefore of significant interest in order to be competitive.In this chapter, four case studies are presented which outline ways to reduce significantly R&D and manufacturing costs by using disposable technology in the frame of a the transfer of an antibody manufacturing process, the preparation of media and buffers in commercial manufacturing and a direct comparison of a traditional and a fully disposable pilot plant.

Classification of huminite-ICCP System 1994

Energy Technology Data Exchange (ETDEWEB)

Sykorova, I. [Institute of Rock Structure and Mechanics, Academy of Science of the Czech Republic, V Holesovicka 41, 182 09 Prague 8 (Czech Republic); Pickel, W. [Coal and Organic Petrology Services Pty Ltd, 23/80 Box Road, Taren Point, NSW 2229 (Australia); Christanis, K. [Department of Geology, University of Patras, 26500 Rio-Patras (Greece); Wolf, M. [Mergelskull 29, 47802 Krefeld (Germany); Taylor, G.H. [15 Hawkesbury Cres, Farrer Act 2607 (Australia); Flores, D. [Departamento de Geologia, Faculdade de Ciencias do Porto, Praca de Gomes Teixeira, 4099-002 Porto (Portugal)

2005-04-12

In the new classification (ICCP System 1994), the maceral group huminite has been revised from the previous classification (ICCP, 1971. Int. Handbook Coal Petr., suppl. to 2nd ed.) to accommodate the nomenclature to changes in the other maceral groups, especially the changes in the vitrinite classification (ICCP, 1998. The new vitrinite classification (ICCP System 1994). Fuel 77, 349-358.). The vitrinite and huminite systems have been correlated so that down to the level of sub-maceral groups, the two systems can be used in parallel. At the level of macerals and for finer classifications, the analyst now has, according to the nature of the coal and the purpose of the analysis, a choice of using either of the two classification systems for huminite and vitrinite. This is in accordance with the new ISO Coal Classification that covers low rank coals as well and allows for the simultaneous use of the huminite and vitrinite nomenclature for low rank coals.

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.

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

Manufacturing, regulatory and commercial challenges of biopharmaceuticals production: a Finnish perspective.

Science.gov (United States)

Närhi, Marko; Nordström, Katrina

2005-04-01

Biopharmaceuticals product development is a broad and multidisciplinary field. Science and technology are combined with new manufacturing, regulatory and commercial challenges. However, although there is ample literature on the molecular biology and biochemistry of products, the implementation of processes from test tube to commercial scale has not received similar attention. Consequently, the present study aims to highlight, from practical point of view, some of the key issues involved with manufacturing technologies of biopharmaceuticals at a commercial scale. Regulatory requirements and investments are also addressed based on the practical experiences of start-up and small companies. Finland is used as a case-example of such companies as this is a EU-member state with strong technological growth and rapidly increasing number of biotech companies.

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.

Multivariate PAT solutions for biopharmaceutical cultivation: current progress and limitations

NARCIS (Netherlands)

Mercier, S.M.; Diepenbroek, B.; Wijffels, R.H.; Streefland, M.

2014-01-01

Increasingly elaborate and voluminous datasets are generated by the (bio)pharmaceutical industry and are a major challenge for application of PAT and QbD principles. Multivariate data analysis (MVDA) is required to delineate relevant process information from large multi-factorial and multi-collinear

Cellular targets for improved manufacturing of virus-based biopharmaceuticals in animal cells.

Science.gov (United States)

Rodrigues, Ana F; Carrondo, Manuel J T; Alves, Paula M; Coroadinha, Ana S

2014-12-01

The past decade witnessed the entry into the market of new virus-based biopharmaceuticals produced in animal cells such as oncolytic vectors, virus-like particle vaccines, and gene transfer vectors. Therefore, increased attention and investment to optimize cell culture processes towards enhanced manufacturing of these bioproducts is anticipated. Herein, we review key findings on virus-host interactions that have been explored in cell culture optimization. Approaches supporting improved productivity or quality of vector preparations are discussed, mainly focusing on medium design and genetic manipulation. This review provides an integrated outline for current and future efforts in exploring cellular targets for the optimization of cell culture manufacturing of virus-based biopharmaceuticals. Copyright © 2014 Elsevier Ltd. All rights reserved.

In vitro solubility, dissolution and permeability studies combined with semi-mechanistic modeling to investigate the intestinal absorption of desvenlafaxine from an immediate- and extended release formulation

DEFF Research Database (Denmark)

Franek, F; Jarlfors, A; Larsen, F.

2015-01-01

Desvenlafaxine is a biopharmaceutics classification system (BCS) class 1 (high solubility, high permeability) and biopharmaceutical drug disposition classification system (BDDCS) class 3, (high solubility, poor metabolism; implying low permeability) compound. Thus the rate-limiting step...... not imply low intestinal permeability, as indicated by the BDDCS, merely low duodenal/jejunal permeability....... for desvenlafaxine absorption (i.e. intestinal dissolution or permeation) is not fully clarified. The aim of this study was to investigate whether dissolution and/or intestinal permeability rate-limit desvenlafaxine absorption from an immediate-release formulation (IRF) and Pristiq®, an extended release formulation...

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.

Manufacturing Amorphous Solid Dispersions with a Tailored Amount of Crystallized API for Biopharmaceutical Testing.

Science.gov (United States)

Theil, Frank; Milsmann, Johanna; Anantharaman, Sankaran; van Lishaut, Holger

2018-05-07

The preparation of an amorphous solid dispersion (ASD) by dissolving a poorly water-soluble active pharmaceutical ingredient (API) in a polymer matrix can improve the bioavailability by orders of magnitude. Crystallization of the API in the ASD, though, is an inherent threat for bioavailability. Commonly, the impact of crystalline API on the drug release of the dosage form is studied with samples containing spiked crystallinity. These spiked samples possess implicit differences compared to native crystalline samples, regarding size and spatial distribution of the crystals as well as their molecular environment. In this study, we demonstrate that it is possible to grow defined amounts of crystalline API in solid dosage forms, which enables us to study the biopharmaceutical impact of actual crystallization. For this purpose, we studied the crystal growth in fenofibrate tablets over time under an elevated moisture using transmission Raman spectroscopy (TRS). As a nondestructive method to assess API crystallinity in ASD formulations, TRS enables the monitoring of crystal growth in individual dosage forms. Once the kinetic trace of the crystal growth for a certain environmental condition is determined, this method can be used to produce samples with defined amounts of crystallized API. To investigate the biopharmaceutical impact of crystallized API, non-QC dissolution methods were used, designed to identify differences between the various amounts of crystalline materials present. The drug release in the samples manufactured in this fashion was compared to that of samples with spiked crystallinity. In this study, we present for the first time a method for targeted crystallization of amorphous tablets to simulate crystallized ASDs. This methodology is a valuable tool to generate model systems for biopharmaceutical studies on the impact of crystallinity on the bioavailability.

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.

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.

Assessing the Inventiveness of Bio-Pharmaceuticals under European and US Patent Law

DEFF Research Database (Denmark)

Minssen, Timo

, is utterly wrong, since any DNA and the information it contains is the embodiment of the code of life and should be regarded part of the common heritage of mankind. Some patent opponents go even further and argue for a prohibition of patents on proteins. Others, and in particular the life science industry...... 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...

Casemix classification systems.

Science.gov (United States)

Fetter, R B

1999-01-01

The idea of using casemix classification to manage hospital services is not new, but has been limited by available technology. It was not until after the introduction of Medicare in the United States in 1965 that serious attempts were made to measure hospital production in order to contain spiralling costs. This resulted in a system of casemix classification known as diagnosis related groups (DRGs). This paper traces the development of DRGs and their evolution from the initial version to the All Patient Refined DRGs developed in 1991.

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.

Continuous downstream processing of biopharmaceuticals.

Science.gov (United States)

Jungbauer, Alois

2013-08-01

Continuous manufacturing has been applied in many different industries but has been pursued reluctantly in biotechnology where the batchwise process is still the standard. A shift to continuous operation can improve productivity of a process and substantially reduce the footprint. Continuous operation also allows robust purification of labile biomolecules. A full set of unit operations is available to design continuous downstream processing of biopharmaceuticals. Chromatography, the central unit operation, is most advanced in respect to continuous operation. Here, the problem of 'batch' definition has been solved. This has also paved the way for implementation of continuous downstream processing from a regulatory viewpoint. Economic pressure, flexibility, and parametric release considerations will be the driving force to implement continuous manufacturing strategies in future. Copyright © 2013 Elsevier Ltd. All rights reserved.

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.

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.

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.

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...

Chemometrics-based process analytical technology (PAT) tools: applications and adaptation in pharmaceutical and biopharmaceutical industries.

Science.gov (United States)

Challa, Shruthi; Potumarthi, Ravichandra

2013-01-01

Process analytical technology (PAT) is used to monitor and control critical process parameters in raw materials and in-process products to maintain the critical quality attributes and build quality into the product. Process analytical technology can be successfully implemented in pharmaceutical and biopharmaceutical industries not only to impart quality into the products but also to prevent out-of-specifications and improve the productivity. PAT implementation eliminates the drawbacks of traditional methods which involves excessive sampling and facilitates rapid testing through direct sampling without any destruction of sample. However, to successfully adapt PAT tools into pharmaceutical and biopharmaceutical environment, thorough understanding of the process is needed along with mathematical and statistical tools to analyze large multidimensional spectral data generated by PAT tools. Chemometrics is a chemical discipline which incorporates both statistical and mathematical methods to obtain and analyze relevant information from PAT spectral tools. Applications of commonly used PAT tools in combination with appropriate chemometric method along with their advantages and working principle are discussed. Finally, systematic application of PAT tools in biopharmaceutical environment to control critical process parameters for achieving product quality is diagrammatically represented.

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Proguanil Hydrochloride.

NARCIS (Netherlands)

Plöger, Gerlinde F; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Groot, D I R K W; Langguth, Peter; Mehta, Mehul U; Parr, Alan; Polli, James E; Shah, Vinod P; Tajiri, Tomokazu; Dressman, Jennifer B

2018-01-01

Literature data relevant to the decision to waive in vivo bioequivalence testing for the approval of generic immediate release solid oral dosage forms of proguanil hydrochloride are reviewed. To clarify the Biopharmaceutics Classification System (BCS) classification, experimental solubility and

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

Oral epithelial dysplasia classification systems

DEFF Research Database (Denmark)

Warnakulasuriya, S; Reibel, J; Bouquot, J

2008-01-01

At a workshop coordinated by the WHO Collaborating Centre for Oral Cancer and Precancer in the United Kingdom issues related to potentially malignant disorders of the oral cavity were discussed by an expert group. The consensus views of the Working Group are presented in a series of papers....... 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...... use. Although most oral pathologists possibly recognize and accept the criteria for grading epithelial dysplasia, firstly based on architectural features and then of cytology, there is great variability in their interpretation of the presence, degree and significance of the individual criteria...

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)

The classification of osteonecrosis in patients with cancer: validation of a new radiological classification system

International Nuclear Information System (INIS)

Niinimäki, T.; Niinimäki, J.; Halonen, J.; Hänninen, P.; Harila-Saari, A.; Niinimäki, R.

2015-01-01

Aim: To validate a new, non-joint-specific radiological classification system that is suitable regardless of the site of the osteonecrosis (ON) in patients with cancer. Material and methods: Critical deficiencies in the existing ON classification systems were identified and a new, non-joint-specific radiological classification system was developed. Seventy-two magnetic resonance imaging (MRI) images of patients with cancer and ON lesions were graded, and the validation of the new system was performed by assessing inter- and intra-observer reliability. Results: Intra-observer reliability of ON grading was good or very good, with kappa values of 0.79–0.86. Interobserver agreement was lower but still good, with kappa values of 0.62–0.77. Ninety-eight percent of all intra- or interobserver differences were within one grade. Interobserver reliability of assessing the location of ON was very good, with kappa values of 0.93–0.98. Conclusion: All the available radiological ON classification systems are joint specific. This limitation has spurred the development of multiple systems, which has led to the insufficient use of classifications in ON studies among patients with cancer. The introduced radiological classification system overcomes the problem of joint-specificity, was found to be reliable, and can be used to classify all ON lesions regardless of the affected site. - Highlights: • Patients with cancer may have osteonecrosis lesions at multiple sites. • There is no non-joint-specific osteonecrosis classification available. • We introduced a new non-joint-specific osteonecrosis classification. • The validation was performed by assessing inter- and intra-observer reliability. • The classification was reliable and could be used regardless of the affected site.

A statistical approach to root system classification.

Directory of Open Access Journals (Sweden)

Gernot eBodner

2013-08-01

Full Text Available Plant root systems have a key role in ecology and agronomy. In spite of fast increase in root studies, still there is no classification that allows distinguishing among distinctive characteristics within the diversity of rooting strategies. Our hypothesis is that a multivariate approach for plant functional type identification in ecology can be applied to the classification of root systems. We demonstrate that combining principal component and cluster analysis yields a meaningful classification of rooting types based on morphological traits. The classification method presented is based on a data-defined statistical procedure without a priori decision on the classifiers. Biplot inspection is used to determine key traits and to ensure stability in cluster based grouping. The classification method is exemplified with simulated root architectures and morphological field data. Simulated root architectures showed that morphological attributes with spatial distribution parameters capture most distinctive features within root system diversity. While developmental type (tap vs. shoot-borne systems is a strong, but coarse classifier, topological traits provide the most detailed differentiation among distinctive groups. Adequacy of commonly available morphologic traits for classification is supported by field data. Three rooting types emerged from measured data, distinguished by diameter/weight, density and spatial distribution respectively. Similarity of root systems within distinctive groups was the joint result of phylogenetic relation and environmental as well as human selection pressure. We concluded that the data-define classification is appropriate for integration of knowledge obtained with different root measurement methods and at various scales. Currently root morphology is the most promising basis for classification due to widely used common measurement protocols. To capture details of root diversity efforts in architectural measurement

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

Animal cell cultures: recent achievements and perspectives in the production of biopharmaceuticals.

Science.gov (United States)

Butler, Michael

2005-08-01

There has been a rapid increase in the number and demand for approved biopharmaceuticals produced from animal cell culture processes over the last few years. In part, this has been due to the efficacy of several humanized monoclonal antibodies that are required at large doses for therapeutic use. There have also been several identifiable advances in animal cell technology that has enabled efficient biomanufacture of these products. Gene vector systems allow high specific protein expression and some minimize the undesirable process of gene silencing that may occur in prolonged culture. Characterization of cellular metabolism and physiology has enabled the design of fed-batch and perfusion bioreactor processes that has allowed a significant improvement in product yield, some of which are now approaching 5 g/L. Many of these processes are now being designed in serum-free and animal-component-free media to ensure that products are not contaminated with the adventitious agents found in bovine serum. There are several areas that can be identified that could lead to further improvement in cell culture systems. This includes the down-regulation of apoptosis to enable prolonged cell survival under potentially adverse conditions. The characterization of the critical parameters of glycosylation should enable process control to reduce the heterogeneity of glycoforms so that production processes are consistent. Further improvement may also be made by the identification of glycoforms with enhanced biological activity to enhance clinical efficacy. The ability to produce the ever-increasing number of biopharmaceuticals by animal cell culture is dependent on sufficient bioreactor capacity in the industry. A recent shortfall in available worldwide culture capacity has encouraged commercial activity in contract manufacturing operations. However, some analysts indicate that this still may not be enough and that future manufacturing demand may exceed production capacity as the number

REAL-TIME INTELLIGENT MULTILAYER ATTACK CLASSIFICATION SYSTEM

Directory of Open Access Journals (Sweden)

T. Subbhulakshmi

2014-01-01

Full Text Available Intrusion Detection Systems (IDS takes the lion’s share of the current security infrastructure. Detection of intrusions is vital for initiating the defensive procedures. Intrusion detection was done by statistical and distance based methods. A threshold value is used in these methods to indicate the level of normalcy. When the network traffic crosses the level of normalcy then above which it is flagged as anomalous. When there are occurrences of new intrusion events which are increasingly a key part of system security, the statistical techniques cannot detect them. To overcome this issue, learning techniques are used which helps in identifying new intrusion activities in a computer system. The objective of the proposed system designed in this paper is to classify the intrusions using an Intelligent Multi Layered Attack Classification System (IMLACS which helps in detecting and classifying the intrusions with improved classification accuracy. The intelligent multi layered approach contains three intelligent layers. The first layer involves Binary Support Vector Machine classification for detecting the normal and attack. The second layer involves neural network classification to classify the attacks into classes of attacks. The third layer involves fuzzy inference system to classify the attacks into various subclasses. The proposed IMLACS can be able to detect an intrusion behavior of the networks since the system contains a three intelligent layer classification and better set of rules. Feature selection is also used to improve the time of detection. The experimental results show that the IMLACS achieves the Classification Rate of 97.31%.

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 ...

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.

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.…

A Classification Scheme for Production System Processes

DEFF Research Database (Denmark)

Sørensen, Daniel Grud Hellerup; Brunø, Thomas Ditlev; Nielsen, Kjeld

2018-01-01

Manufacturing companies often have difficulties developing production platforms, partly due to the complexity of many production systems and difficulty determining which processes constitute a platform. Understanding production processes is an important step to identifying candidate processes...... for a production platform based on existing production systems. Reviewing a number of existing classifications and taxonomies, a consolidated classification scheme for processes in production of discrete products has been outlined. The classification scheme helps ensure consistency during mapping of existing...

An evaluation of classification systems for stillbirth.

Science.gov (United States)

Flenady, Vicki; Frøen, J Frederik; Pinar, Halit; Torabi, Rozbeh; Saastad, Eli; Guyon, Grace; Russell, Laurie; Charles, Adrian; Harrison, Catherine; Chauke, Lawrence; Pattinson, Robert; Koshy, Rachel; Bahrin, Safiah; Gardener, Glenn; Day, Katie; Petersson, Karin; Gordon, Adrienne; Gilshenan, Kristen

2009-06-19

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. 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 <2 considered unsatisfactory); inter-observer agreement and the proportion of unexplained stillbirths. A randomly selected subset of 100 stillbirths was used to assess inter-observer agreement. InfoKeep scores were significantly different across the classifications (p < or = 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 < or = 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. 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

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.

Improved Protease-Targeting and Biopharmaceutical Properties of Novel Prodrugs of Ganciclovir.

Science.gov (United States)

Sun, Kefeng; Xu, Hao; Hilfinger, John L; Lee, Kyung-Dall; Provoda, Chester J; Sabit, Hairat; Amidon, Gordon L

2018-02-05

The prodrug strategy has been frequently employed as a chemical approach for overcoming the disadvantages of existing parent drugs. In this report, we synthesized four monoester prodrugs of ganciclovir, an anticytomegalovirus drug, and demonstrated their potential advantages in protease-targeted activation and biopharmaceutical profiles over the parent compound. We demonstrated that these four prodrugs of ganciclovir, i.e., N-benzyloxycarbonyl-(L)-alanine-ganciclovir (CbzAlaGCV), N-benzyloxycarbonyl-(α,l)-aminobutyric acid-ganciclovir (CbzAbuGCV), N-acetyl-(l)-phenylalanine-(l)-alanine-ganciclovir (AcPheAlaGCV), and N-acetyl-(l)-phenylalanine-(α,l)-aminobutyric acid-ganciclovir (AcPheAbuGCV), are hydrolytically activated by the protease of human cytomegalovirus (hCMV), a serine protease that possesses intrinsic esterase activities. CbzAlaGCV and AcPheAlaGCV were found to be activated at a higher rate by the hCMV protease than CbzAbuGCV and AcPheAbuGCV. These ganciclovir prodrugs could potentially be targeted to selective activation by the hCMV protease which is only present at the viral infection sites, thereby achieving higher efficacy and lower systemic toxicity. The tissue stability, cellular uptake, and trans-epithelial transport of these ganciclovir prodrugs were also characterized. The N-acetylated dipeptide prodrugs of ganciclovir were found to be generally more stable than Cbz-amino acid prodrugs in various tissue matrices. Among the four prodrug candidates, AcPheAbuGCV was the most stable in human cell homogenates, plasma, and pooled liver microsomes. AcPheAbuGCV also possessed a superior cellular uptake profile and permeability across epithelial cell monolayers. Since the targeting and selective activation of a prodrug is determined by not only its rate of hydrolysis catalyzed by the hCMV protease target but also its biopharmaceutical properties, i.e., oral absorption and systemic availability, AcPheAbuGCV is considered the best overall candidate among

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

A Confidence Paradigm for Classification Systems

Science.gov (United States)

2008-09-01

methodology to determine how much confi- dence one should have in a classifier output. This research proposes a framework to determine the level of...theoretical framework that attempts to unite the viewpoints of the classification system developer (or engineer) and the classification system user (or...operating point. An algorithm is developed that minimizes a “confidence” measure called Binned Error in the Posterior ( BEP ). Then, we prove that training a

A proposed United States resource classification system

International Nuclear Information System (INIS)

Masters, C.D.

1980-01-01

Energy is a world-wide problem calling for world-wide communication to resolve the many supply and distribution problems. Essential to a communication problem are a definition and comparability of elements being communicated. The US Geological Survey, with the co-operation of the US Bureau of Mines and the US Department of Energy, has devised a classification system for all mineral resources, the principles of which, it is felt, offer the possibility of world communication. At present several other systems, extant or under development (Potential Gas Committee of the USA, United Nations Resource Committee, and the American Society of Testing and Materials) are internally consistent and provide easy communication linkage. The system in use by the uranium community in the United States of America, however, ties resource quantities to forward-cost dollar values rendering them inconsistent with other classifications and therefore not comparable. This paper develops the rationale for the new USGS resource classification and notes its benefits relative to a forward-cost classification and its relationship specifically to other current classifications. (author)

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.

Automotive System for Remote Surface Classification.

Science.gov (United States)

Bystrov, Aleksandr; Hoare, Edward; Tran, Thuy-Yung; Clarke, Nigel; Gashinova, Marina; Cherniakov, Mikhail

2017-04-01

In this paper we shall discuss a novel approach to road surface recognition, based on the analysis of backscattered microwave and ultrasonic signals. The novelty of our method is sonar and polarimetric radar data fusion, extraction of features for separate swathes of illuminated surface (segmentation), and using of multi-stage artificial neural network for surface classification. The developed system consists of 24 GHz radar and 40 kHz ultrasonic sensor. The features are extracted from backscattered signals and then the procedures of principal component analysis and supervised classification are applied to feature data. The special attention is paid to multi-stage artificial neural network which allows an overall increase in classification accuracy. The proposed technique was tested for recognition of a large number of real surfaces in different weather conditions with the average accuracy of correct classification of 95%. The obtained results thereby demonstrate that the use of proposed system architecture and statistical methods allow for reliable discrimination of various road surfaces in real conditions.

Determination of Regional Intestinal Permeability of Diclofenac and ...

African Journals Online (AJOL)

Keywords: Biopharmaceutics classification system, Diclofenac, Metoprolol tartrate, ... intestinal transit of drug formulations is about 3 - ... delivery of perfusion medium to the excised ..... of diclofenac in transdermal therapeutic preparations.

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.

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... intermediary decides that a different LTC-DRG should be assigned, the case will be reviewed by the appropriate... 42 Public Health 2 2010-10-01 2010-10-01 false Patient classification system. 412.513 Section 412...

Revised Soil Classification System for Coarse-Fine Mixtures

KAUST Repository

Park, Junghee; Santamarina, Carlos

2017-01-01

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.

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.

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.

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.

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

A new tree classification system for southern hardwoods

Science.gov (United States)

James S. Meadows; Daniel A. Jr. Skojac

2008-01-01

A new tree classification system for southern hardwoods is described. The new system is based on the Putnam tree classification system, originally developed by Putnam et al., 1960, Management ond inventory of southern hardwoods, Agriculture Handbook 181, US For. Sew., Washington, DC, which consists of four tree classes: (1) preferred growing stock, (2) reserve growing...

Light-water reactors reference system classification for the European reliability data system (ERDS)

International Nuclear Information System (INIS)

Melis, M.; Mancini, G.

1982-01-01

The reference system classification represents a basic stage in the organization of the European reliability data system (ERDS) for light-water reactors, a project actually in development at the Joint Research Centre, Ispra. This project is concerned with operational reliability data collection from the various ''national'' data banks, and centralization in a European reliability data system, so improving the significance of the resulting reliability evaluations. In the framework of the ERDS project, the reference system classification provides a LWR functional break-down and represents a plant-unique identification in the process of homogenization of event-data coming from the various ''national'' organizations. The report, after a brief description of the main objectives of the ERDS project, reviews the criteria followed in the elaboration of the reference system classification; then the detailed classification is presented. The nuclear power station is subdivided in about 180 systems. To each system a sheet is associated, containing: a comprehensive description of system-functions and boundaries; a descritpion of the plant operating mode, linked to the various system functions; a list of the main interface system; and finally, a list of the main components, including type and safety classification

Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing.

Science.gov (United States)

Jiang, Mo; Severson, Kristen A; Love, John Christopher; Madden, Helena; Swann, Patrick; Zang, Li; Braatz, Richard D

2017-11-01

Real-time release testing (RTRT) is defined as "the ability to evaluate and ensure the quality of in-process and/or final drug product based on process data, which typically includes a valid combination of measured material attributes and process controls" (ICH Q8[R2]). This article discusses sensors (process analytical technology, PAT) and control strategies that enable RTRT for the spectrum of critical quality attributes (CQAs) in biopharmaceutical manufacturing. Case studies from the small-molecule and biologic pharmaceutical industry are described to demonstrate how RTRT can be facilitated by integrated manufacturing and multivariable control strategies to ensure the quality of products. RTRT can enable increased assurance of product safety, efficacy, and quality-with improved productivity including faster release and potentially decreased costs-all of which improve the value to patients. To implement a complete RTRT solution, biologic drug manufacturers need to consider the special attributes of their industry, particularly sterility and the measurement of viral and microbial contamination. Continued advances in on-line and in-line sensor technologies are key for the biopharmaceutical manufacturing industry to achieve the potential of RTRT. Related article: http://onlinelibrary.wiley.com/doi/10.1002/bit.26378/full. © 2017 Wiley Periodicals, Inc.

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

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.

Impact of Magnetic Stirring on Stainless Steel Integrity: Effect on Biopharmaceutical Processing.

Science.gov (United States)

Thompson, Christopher; Wilson, Kelly; Kim, Yoen Joo; Xie, Min; Wang, William K; Wendeler, Michaela

2017-11-01

Stainless steel containers are widely used in the pharmaceutical and biopharmaceutical industry for the storage of buffers, process intermediates, and purified drug substance. They are generally held to be corrosion resistant, biocompatible, and nonreactive, although it is well established that trace amounts of metal ions can leach from stainless steel equipment into biopharmaceutical products. We report here that the use of stainless steel containers in conjunction with magnetic stirring bars leads to significantly aggravated metal contamination, consisting of both metal particles and significantly elevated metal ions in solution, the degree of which is several orders of magnitude higher than described for static conditions. Metal particles are analyzed by scanning electron microscopy with electron-dispersive X-ray spectroscopy, and metal content in solution is quantitated at different time points by inductively coupled plasma-mass spectrometry. The concentration of iron, chromium, nickel, and manganese increases with increasing stirring time and speed. We describe the impact of buffer components on the extent of metal particles and ions in solution and illustrate the effect on model proteins. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Characterization of Protein-Excipient Microheterogeneity in Biopharmaceutical Solid-State Formulations by Confocal Fluorescence Microscopy.

Science.gov (United States)

Koshari, Stijn H S; Ross, Jean L; Nayak, Purnendu K; Zarraga, Isidro E; Rajagopal, Karthikan; Wagner, Norman J; Lenhoff, Abraham M

2017-02-06

Protein-stabilizer microheterogeneity is believed to influence long-term protein stability in solid-state biopharmaceutical formulations and its characterization is therefore essential for the rational design of stable formulations. However, the spatial distribution of the protein and the stabilizer in a solid-state formulation is, in general, difficult to characterize because of the lack of a functional, simple, and reliable characterization technique. We demonstrate the use of confocal fluorescence microscopy with fluorescently labeled monoclonal antibodies (mAbs) and antibody fragments (Fabs) to directly visualize three-dimensional particle morphologies and protein distributions in dried biopharmaceutical formulations, without restrictions on processing conditions or the need for extensive data analysis. While industrially relevant lyophilization procedures of a model IgG1 mAb generally lead to uniform protein-excipient distribution, the method shows that specific spray-drying conditions lead to distinct protein-excipient segregation. Therefore, this method can enable more definitive optimization of formulation conditions than has previously been possible.

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

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.

Towards a consensus on a hearing preservation classification system.

Science.gov (United States)

Skarzynski, Henryk; van de Heyning, P; Agrawal, S; Arauz, S L; Atlas, M; Baumgartner, W; Caversaccio, M; de Bodt, M; Gavilan, J; Godey, B; Green, K; Gstoettner, W; Hagen, R; Han, D M; Kameswaran, M; Karltorp, E; Kompis, M; Kuzovkov, V; Lassaletta, L; Levevre, F; Li, Y; Manikoth, M; Martin, J; Mlynski, R; Mueller, J; O'Driscoll, M; Parnes, L; Prentiss, S; Pulibalathingal, S; Raine, C H; Rajan, G; Rajeswaran, R; Rivas, J A; Rivas, A; Skarzynski, P H; Sprinzl, G; Staecker, H; Stephan, K; Usami, S; Yanov, Y; Zernotti, M E; Zimmermann, K; Lorens, A; Mertens, G

2013-01-01

The comprehensive Hearing Preservation classification system presented in this paper is suitable for use for all cochlear implant users with measurable pre-operative residual hearing. If adopted as a universal reporting standard, as it was designed to be, it should prove highly beneficial by enabling future studies to quickly and easily compare the results of previous studies and meta-analyze their data. To develop a comprehensive Hearing Preservation classification system suitable for use for all cochlear implant users with measurable pre-operative residual hearing. The HEARRING group discussed and reviewed a number of different propositions of a HP classification systems and reviewed critical appraisals to develop a qualitative system in accordance with the prerequisites. The Hearing Preservation Classification System proposed herein fulfills the following necessary criteria: 1) classification is independent from users' initial hearing, 2) it is appropriate for all cochlear implant users with measurable pre-operative residual hearing, 3) it covers the whole range of pure tone average from 0 to 120 dB; 4) it is easy to use and easy to understand.

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...

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 ...

Multivariate statistical monitoring as applied to clean-in-place (CIP) and steam-in-place (SIP) operations in biopharmaceutical manufacturing.

Science.gov (United States)

Roy, Kevin; Undey, Cenk; Mistretta, Thomas; Naugle, Gregory; Sodhi, Manbir

2014-01-01

Multivariate statistical process monitoring (MSPM) is becoming increasingly utilized to further enhance process monitoring in the biopharmaceutical industry. MSPM can play a critical role when there are many measurements and these measurements are highly correlated, as is typical for many biopharmaceutical operations. Specifically, for processes such as cleaning-in-place (CIP) and steaming-in-place (SIP, also known as sterilization-in-place), control systems typically oversee the execution of the cycles, and verification of the outcome is based on offline assays. These offline assays add to delays and corrective actions may require additional setup times. Moreover, this conventional approach does not take interactive effects of process variables into account and cycle optimization opportunities as well as salient trends in the process may be missed. Therefore, more proactive and holistic online continued verification approaches are desirable. This article demonstrates the application of real-time MSPM to processes such as CIP and SIP with industrial examples. The proposed approach has significant potential for facilitating enhanced continuous verification, improved process understanding, abnormal situation detection, and predictive monitoring, as applied to CIP and SIP operations. © 2014 American Institute of Chemical Engineers.

Design and implementation based on the classification protection vulnerability scanning system

International Nuclear Information System (INIS)

Wang Chao; Lu Zhigang; Liu Baoxu

2010-01-01

With the application and spread of the classification protection, Network Security Vulnerability Scanning should consider the efficiency and the function expansion. It proposes a kind of a system vulnerability from classification protection, and elaborates the design and implementation of a vulnerability scanning system based on vulnerability classification plug-in technology and oriented classification protection. According to the experiment, the application of classification protection has good adaptability and salability with the system, and it also approves the efficiency of scanning. (authors)

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......" rates. The classification system has a multifacetted non-hierarchical struc-ture and its compatibility with Isprals 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 malfunc-tions and of a human decision sequence are described....

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)

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.

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

Second International Conference on Accelerating Biopharmaceutical Development

Science.gov (United States)

2009-01-01

The Second International Conference on Accelerating Biopharmaceutical Development was held in Coronado, California. The meeting was organized by the Society for Biological Engineering (SBE) and the American Institute of Chemical Engineers (AIChE); SBE is a technological community of the AIChE. Bob Adamson (Wyeth) and Chuck Goochee (Centocor) were co-chairs of the event, which had the theme “Delivering cost-effective, robust processes and methods quickly and efficiently.” The first day focused on emerging disruptive technologies and cutting-edge analytical techniques. Day two featured presentations on accelerated cell culture process development, critical quality attributes, specifications and comparability, and high throughput protein formulation development. The final day was dedicated to discussion of technology options and new analysis methods provided by emerging disruptive technologies; functional interaction, integration and synergy in platform development; and rapid and economic purification process development. PMID:20065637

Single-use disposable technologies for biopharmaceutical manufacturing.

Science.gov (United States)

Shukla, Abhinav A; Gottschalk, Uwe

2013-03-01

The manufacture of protein biopharmaceuticals is conducted under current good manufacturing practice (cGMP) and involves multiple unit operations for upstream production and downstream purification. Until recently, production facilities relied on the use of relatively inflexible, hard-piped equipment including large stainless steel bioreactors and tanks to hold product intermediates and buffers. However, there is an increasing trend towards the adoption of single-use technologies across the manufacturing process. Technical advances have now made an end-to-end single-use manufacturing facility possible, but several aspects of single-use technology require further improvement and are continually evolving. This article provides a perspective on the current state-of-the-art in single-use technologies and highlights trends that will improve performance and increase the market penetration of disposable manufacturing in the future. Copyright © 2012 Elsevier Ltd. All rights reserved.

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.

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...

Oral delivery of human biopharmaceuticals, autoantigens and vaccine antigens bioencapsulated in plant cells.

Science.gov (United States)

Kwon, Kwang-Chul; Verma, Dheeraj; Singh, Nameirakpam D; Herzog, Roland; Daniell, Henry

2013-06-15

Among 12billion injections administered annually, unsafe delivery leads to >20million infections and >100million reactions. In an emerging new concept, freeze-dried plant cells (lettuce) expressing vaccine antigens/biopharmaceuticals are protected in the stomach from acids/enzymes but are released to the immune or blood circulatory system when plant cell walls are digested by microbes that colonize the gut. Vaccine antigens bioencapsulated in plant cells upon oral delivery after priming, conferred both mucosal and systemic immunity and protection against bacterial, viral or protozoan pathogens or toxin challenge. Oral delivery of autoantigens was effective against complications of type 1 diabetes and hemophilia, by developing tolerance. Oral delivery of proinsulin or exendin-4 expressed in plant cells regulated blood glucose levels similar to injections. Therefore, this new platform offers a low cost alternative to deliver different therapeutic proteins to combat infectious or inherited diseases by eliminating inactivated pathogens, expensive purification, cold storage/transportation and sterile injections. Copyright © 2012 Elsevier B.V. All rights reserved.

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.

42 CFR 412.10 - Changes in the DRG classification system.

Science.gov (United States)

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Changes in the DRG classification system. 412.10... § 412.10 Changes in the DRG classification system. (a) General rule. CMS issues changes in the DRG... after the same date the payment rates are effective. (b) Basis for changes in the DRG classification...

Hydrogen deuterium exchange mass spectrometry in biopharmaceutical discovery and development – A review

International Nuclear Information System (INIS)

Deng, Bin; Lento, Cristina; Wilson, Derek J.

2016-01-01

Protein therapeutics have emerged as a major class of biopharmaceuticals over the past several decades, a trend that has motivated the advancement of bioanalytical technologies for protein therapeutic characterization. Hydrogen deuterium exchange mass spectrometry (HDX-MS) is a powerful and sensitive technique that can probe the higher order structure of proteins and has been used in the assessment and development of monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs) and biosimilar antibodies. It has also been used to quantify protein-ligand, protein-receptor and other protein-protein interactions involved in signaling pathways. In manufacturing and development, HDX-MS can validate storage formulations and manufacturing processes for various biotherapeutics. Currently, HDX-MS is being refined to provide additional coverage, sensitivity and structural specificity and implemented on the millisecond timescale to reveal residual structure and dynamics in disordered domains and intrinsically disordered proteins. - Highlights: • The pharmaceuticals industry is increasingly shifting to protein therapeutics. • Hydrogen deuterium exchange mass spectrometry is uniquely well suited to support biopharmaceutical development. • Applications for hydrogen deuterium exchange span drug discovery, development and manufacturing. • Future developments will allow improved sensitivity, structural resolution and a broader range of dynamics to be monitored.

Hydrogen deuterium exchange mass spectrometry in biopharmaceutical discovery and development – A review

Energy Technology Data Exchange (ETDEWEB)

Deng, Bin, E-mail: dengbin@yorku.ca [Chemistry Department, York University, 4700 Keele Street, Toronto, ON, M3J 1P3 (Canada); The Centre for Research in Mass Spectrometry, York University, Toronto, ON, M3J1P3 (Canada); Lento, Cristina, E-mail: clento@yorku.ca [Chemistry Department, York University, 4700 Keele Street, Toronto, ON, M3J 1P3 (Canada); The Centre for Research in Mass Spectrometry, York University, Toronto, ON, M3J1P3 (Canada); Wilson, Derek J., E-mail: dkwilson@yorku.ca [Chemistry Department, York University, 4700 Keele Street, Toronto, ON, M3J 1P3 (Canada); The Centre for Research in Mass Spectrometry, York University, Toronto, ON, M3J1P3 (Canada)

2016-10-12

Protein therapeutics have emerged as a major class of biopharmaceuticals over the past several decades, a trend that has motivated the advancement of bioanalytical technologies for protein therapeutic characterization. Hydrogen deuterium exchange mass spectrometry (HDX-MS) is a powerful and sensitive technique that can probe the higher order structure of proteins and has been used in the assessment and development of monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs) and biosimilar antibodies. It has also been used to quantify protein-ligand, protein-receptor and other protein-protein interactions involved in signaling pathways. In manufacturing and development, HDX-MS can validate storage formulations and manufacturing processes for various biotherapeutics. Currently, HDX-MS is being refined to provide additional coverage, sensitivity and structural specificity and implemented on the millisecond timescale to reveal residual structure and dynamics in disordered domains and intrinsically disordered proteins. - Highlights: • The pharmaceuticals industry is increasingly shifting to protein therapeutics. • Hydrogen deuterium exchange mass spectrometry is uniquely well suited to support biopharmaceutical development. • Applications for hydrogen deuterium exchange span drug discovery, development and manufacturing. • Future developments will allow improved sensitivity, structural resolution and a broader range of dynamics to be monitored.

CLASSIFICATION OF THE MGR WASTE EMPLACEMENT/RETRIEVAL SYSTEM

International Nuclear Information System (INIS)

J.A. Ziegler

2000-01-01

The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) waste emplacement/retrieved 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-0333P, Quality Assurance Requirements and Description (QARD) (DOE 2000). This QA classification incorporates the current MGR design and the results of the ''Design Basis Event Frequency and Dose Calculation for Site Recommendation'' (CRWMS M andO 2000a). The content and technical approach of this analysis is in accordance with the development plan ''QA Classification of MGR Structures, Systems, and Components'' (CRWMS M andO 1999b)

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.

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

Classification systems are foundational in many standardized software tools. This digitization of classification systems gives them a new ‘materiality’ that, jointly with the social practices of information producers/consumers, has significant consequences on the representational quality of such ...... and the foundational role of representational quality in understanding the success and consequences of data-driven decision-making.......-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...

Validation of potential classification criteria for systemic sclerosis.

NARCIS (Netherlands)

Johnson, S.R.; Fransen, J.; Khanna, D.; Baron, M.; Hoogen, F. van den; Medsger TA, J.r.; Peschken, C.A.; Carreira, P.E.; Riemekasten, G.; Tyndall, A.; Matucci-Cerinic, M.; Pope, J.E.

2012-01-01

OBJECTIVE: Classification criteria for systemic sclerosis (SSc; scleroderma) are being updated jointly by the American College of Rheumatology and European League Against Rheumatism. Potential items for classification were reduced to 23 using Delphi and nominal group techniques. We evaluated the

Principles for interactions with biopharmaceutical companies: the development of guidelines for patient advocacy organizations in the field of rare diseases.

Science.gov (United States)

Stein, Susan; Bogard, Elizabeth; Boice, Nicole; Fernandez, Vivian; Field, Tessa; Gilstrap, Alan; Kahn, Susan R; Larkindale, Jane; Mathieson, Toni

2018-01-22

Rare diseases are a global public health concern, affecting an estimated 350 million individuals. Only 5% of approximately 7000 known rare diseases have a treatment, and only about half have a patient advocacy organization. Biopharmaceutical companies face complex challenges in developing treatments for rare diseases. Patient advocacy organizations may play a major role by positively influencing research and development, clinical trials, and regulations. Thus, collaboration among patient advocacy organizations and industry is essential to bring new therapeutics to patients. We identified an unmet need for guidelines on day-to-day decision-making by rare disease patient advocacy organizations when working with biopharmaceutical partners. We convened an Independent Expert Panel experienced in collaborations between patient advocacy organizations and biopharmaceutical companies (April 2017) to develop consensus guidelines for these relationships. The guidelines were based on an original version by the International Fibrodysplasia Ossificans Progressiva Association (IFOPA). The Expert Panel reviewed and broadened these to be applicable to all patient advocacy organizations. Comments on the draft Guidelines were provided first by Panel participants and subsequently by six independent experts from patient advocacy organizations and industry. The Panel comprised four experts from the rare disease community who lead patient advocacy organizations; three leaders who perform advocacy functions within biopharmaceutical companies; and two facilitators, both having leadership experience in rare diseases and industry. The finalized Guidelines consist of four main sections: Identification and Engagement With Companies, Patient Engagement and Patient Privacy, Financial Contributions, and Clinical Trial Communication and Support. The Guidelines address the daily considerations, choices, and consequences of patient advocacy organizations as they engage with biopharmaceutical

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

Development of a classification system for cup anemometers - CLASSCUP

DEFF Research Database (Denmark)

Friis Pedersen, Troels

2003-01-01

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

Calculating radiation exposures during use of (14)C-labeled nutrients, food components, and biopharmaceuticals to quantify metabolic behavior in humans.

Science.gov (United States)

Kim, Seung-Hyun; Kelly, Peter B; Clifford, Andrew J

2010-04-28

(14)C has long been used as a tracer for quantifying the in vivo human metabolism of food components, biopharmaceuticals, and nutrients. Minute amounts (food components, biopharmaceuticals, or nutrients to be organized into models suitable for quantitative hypothesis testing and determination of metabolic parameters. In vivo models are important for specification of intake levels for food components, biopharmaceuticals, and nutrients. Accurate estimation of the radiation exposure from ingested (14)C is an essential component of the experimental design. Therefore, this paper illustrates the calculation involved in determining the radiation exposure from a minute dose of orally administered (14)C-beta-carotene, (14)C-alpha-tocopherol, (14)C-lutein, and (14)C-folic acid from four prior experiments. The administered doses ranged from 36 to 100 nCi, and radiation exposure ranged from 0.12 to 5.2 microSv to whole body and from 0.2 to 3.4 microSv to liver with consideration of tissue weighting factor and fractional nutrient. In comparison, radiation exposure experienced during a 4 h airline flight across the United States at 37000 ft was 20 microSv.

Low-cost real-time automatic wheel classification system

Science.gov (United States)

Shabestari, Behrouz N.; Miller, John W. V.; Wedding, Victoria

1992-11-01

This paper describes the design and implementation of a low-cost machine vision system for identifying various types of automotive wheels which are manufactured in several styles and sizes. In this application, a variety of wheels travel on a conveyor in random order through a number of processing steps. One of these processes requires the identification of the wheel type which was performed manually by an operator. A vision system was designed to provide the required identification. The system consisted of an annular illumination source, a CCD TV camera, frame grabber, and 386-compatible computer. Statistical pattern recognition techniques were used to provide robust classification as well as a simple means for adding new wheel designs to the system. Maintenance of the system can be performed by plant personnel with minimal training. The basic steps for identification include image acquisition, segmentation of the regions of interest, extraction of selected features, and classification. The vision system has been installed in a plant and has proven to be extremely effective. The system properly identifies the wheels correctly up to 30 wheels per minute regardless of rotational orientation in the camera's field of view. Correct classification can even be achieved if a portion of the wheel is blocked off from the camera. Significant cost savings have been achieved by a reduction in scrap associated with incorrect manual classification as well as a reduction of labor in a tedious task.

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.

Capillary electrophoresis – mass spectrometry using noncovalently coated capillaries for the analysis of biopharmaceuticals

OpenAIRE

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 manufacturing. The biotechnological production process may show variability, which can introduce product diversity, isoforms and closely-related degradation products. Clearly, there is an increasing demand fo...

Changing patient classification system for hospital reimbursement in Romania.

Science.gov (United States)

Radu, Ciprian-Paul; Chiriac, Delia Nona; Vladescu, Cristian

2010-06-01

To evaluate the effects of the change in the diagnosis-related group (DRG) system on patient morbidity and hospital financial performance in the Romanian public health care system. Three variables were assessed before and after the classification switch in July 2007: clinical outcomes, the case mix index, and hospital budgets, using the database of the National School of Public Health and Health Services Management, which contains data regularly received from hospitals reimbursed through the Romanian DRG scheme (291 in 2009). The lack of a Romanian system for the calculation of cost-weights imposed the necessity to use an imported system, which was criticized by some clinicians for not accurately reflecting resource consumption in Romanian hospitals. The new DRG classification system allowed a more accurate clinical classification. However, it also exposed a lack of physicians' knowledge on diagnosing and coding procedures, which led to incorrect coding. Consequently, the reported hospital morbidity changed after the DRG switch, reflecting an increase in the national case-mix index of 25% in 2009 (compared with 2007). Since hospitals received the same reimbursement over the first two years after the classification switch, the new DRG system led them sometimes to change patients' diagnoses in order to receive more funding. Lack of oversight of hospital coding and reporting to the national reimbursement scheme allowed the increase in the case-mix index. The complexity of the new classification system requires more resources (human and financial), better monitoring and evaluation, and improved legislation in order to achieve better hospital resource allocation and more efficient patient care.

The new vitrinite classification (ICCP System 1994)

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-04-01

This paper has been prepared by the International Committee for Coal and Organic Petrology (ICCP). Within the new vitrinite classification (ICCP System 1994) the maceral group vitrinite is divided into three subgroups, telovitrinite, detrovitrinite and gelovitrinite, which are each further sub-divided into two macerals. The dominant parameter for these newly ordered and in part newly defined sub-groups is the degree of destruction (degradation), whereas the macerals can be further distinguished by their morphological characteristics and their degree of gelificiation. The new system is furthermore related more closely to the huminite classification system still in use and a future one to be published by the ICCP. 69 refs., 2 figs., 2 tabs.

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.

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.

Understanding the use of standardized nursing terminology and classification systems in published research: A case study using the International Classification for Nursing Practice(®).

Science.gov (United States)

Strudwick, Gillian; Hardiker, Nicholas R

2016-10-01

In the era of evidenced based healthcare, nursing is required to demonstrate that care provided by nurses is associated with optimal patient outcomes, and a high degree of quality and safety. The use of standardized nursing terminologies and classification systems are a way that nursing documentation can be leveraged to generate evidence related to nursing practice. Several widely-reported nursing specific terminologies and classifications systems currently exist including the Clinical Care Classification System, International Classification for Nursing Practice(®), Nursing Intervention Classification, Nursing Outcome Classification, Omaha System, Perioperative Nursing Data Set and NANDA International. However, the influence of these systems on demonstrating the value of nursing and the professions' impact on quality, safety and patient outcomes in published research is relatively unknown. This paper seeks to understand the use of standardized nursing terminology and classification systems in published research, using the International Classification for Nursing Practice(®) as a case study. A systematic review of international published empirical studies on, or using, the International Classification for Nursing Practice(®) were completed using Medline and the Cumulative Index for Nursing and Allied Health Literature. Since 2006, 38 studies have been published on the International Classification for Nursing Practice(®). The main objectives of the published studies have been to validate the appropriateness of the classification system for particular care areas or populations, further develop the classification system, or utilize it to support the generation of new nursing knowledge. To date, most studies have focused on the classification system itself, and a lesser number of studies have used the system to generate information about the outcomes of nursing practice. Based on the published literature that features the International Classification for Nursing

Accurate crop classification using hierarchical genetic fuzzy rule-based systems

Science.gov (United States)

Topaloglou, Charalampos A.; Mylonas, Stelios K.; Stavrakoudis, Dimitris G.; Mastorocostas, Paris A.; Theocharis, John B.

2014-10-01

This paper investigates the effectiveness of an advanced classification system for accurate crop classification using very high resolution (VHR) satellite imagery. Specifically, a recently proposed genetic fuzzy rule-based classification system (GFRBCS) is employed, namely, the Hierarchical Rule-based Linguistic Classifier (HiRLiC). HiRLiC's model comprises a small set of simple IF-THEN fuzzy rules, easily interpretable by humans. One of its most important attributes is that its learning algorithm requires minimum user interaction, since the most important learning parameters affecting the classification accuracy are determined by the learning algorithm automatically. HiRLiC is applied in a challenging crop classification task, using a SPOT5 satellite image over an intensively cultivated area in a lake-wetland ecosystem in northern Greece. A rich set of higher-order spectral and textural features is derived from the initial bands of the (pan-sharpened) image, resulting in an input space comprising 119 features. The experimental analysis proves that HiRLiC compares favorably to other interpretable classifiers of the literature, both in terms of structural complexity and classification accuracy. Its testing accuracy was very close to that obtained by complex state-of-the-art classification systems, such as the support vector machines (SVM) and random forest (RF) classifiers. Nevertheless, visual inspection of the derived classification maps shows that HiRLiC is characterized by higher generalization properties, providing more homogeneous classifications that the competitors. Moreover, the runtime requirements for producing the thematic map was orders of magnitude lower than the respective for the competitors.

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 and obta...

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.)

CLASSIFICATION OF THE MGR WASTE HANDLING BUILDING VENTILATION SYSTEM

International Nuclear Information System (INIS)

J.A. Ziegler

2000-01-01

The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) waste handling building ventilation 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-0333P, ''Quality Assurance Requirements and Description'' (QARD) (DOE 2000). This QA classification incorporates the current MGR design and the results of the ''Design Basis Event Frequency and Dose Calculation for Site Recommendation'' (CRWMS M andO 2000a) and ''Bounding Individual Category 1 Design Basis Event Dose Calculation to Support Quality Assurance Classification'' (Gwyn 2000)

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

The Nutraceutical Bioavailability Classification Scheme: Classifying Nutraceuticals According to Factors Limiting their Oral Bioavailability.

Science.gov (United States)

McClements, David Julian; Li, Fang; Xiao, Hang

2015-01-01

The oral bioavailability of a health-promoting dietary component (nutraceutical) may be limited by various physicochemical and physiological phenomena: liberation from food matrices, solubility in gastrointestinal fluids, interaction with gastrointestinal components, chemical degradation or metabolism, and epithelium cell permeability. Nutraceutical bioavailability can therefore be improved by designing food matrices that control their bioaccessibility (B*), absorption (A*), and transformation (T*) within the gastrointestinal tract (GIT). This article reviews the major factors influencing the gastrointestinal fate of nutraceuticals, and then uses this information to develop a new scheme to classify the major factors limiting nutraceutical bioavailability: the nutraceutical bioavailability classification scheme (NuBACS). This new scheme is analogous to the biopharmaceutical classification scheme (BCS) used by the pharmaceutical industry to classify drug bioavailability, but it contains additional factors important for understanding nutraceutical bioavailability in foods. The article also highlights potential strategies for increasing the oral bioavailability of nutraceuticals based on their NuBACS designation (B*A*T*).

CLASSIFICATION OF THE MGR MUCK HANDLING 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) muck 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). This QA classification incorporates the current MGR design and the results of the ''Preliminary Preclosure Design Basis Event Calculations for the Monitored Geologic Repository (CRWMS M and O 1998a)

Biopharmaceutical characterization of praziquantel cocrystals and cyclodextrin complexes prepared by grinding.

Science.gov (United States)

Cugovčan, Martina; Jablan, Jasna; Lovrić, Jasmina; Cinčić, Dominik; Galić, Nives; Jug, Mario

2017-04-15

Mechanochemical activation using several different co-grinding additives was applied as a green chemistry approach to improve physiochemical and biopharmaceutical properties of praziquantel (PZQ). Liquid assisted grinding with an equimolar amount of citric acid (CA), malic acid (MA), salicylic acid (SA) and tartaric acid (TA) gained in cocrystal formation, which all showed pH-dependent solubility and dissolution rate. However, the most soluble cocrystal of PZQ with MA was chemically unstable, as seen during the stability testing. Equimolar cyclodextrin complexes prepared by neat grinding with amorphous hydroxypropyl-β-cyclodextrin (HPβCD) and randomly methylated β-cyclodextrin (MEβCD) showed the highest improvement in drug solubility and the dissolution rate, but only PZQ/HPβCD product presented an acceptable chemical and photostability profile. A combined approach, by co-grinding the drug with both MA and HPβCD in equimolar ratio, also gave highly soluble amorphous product which again was chemical instable and therefore not suitable for the pharmaceutical use. Studies on Caco-2 monolayer confirmed the biocompatibility of PZQ/HPβCD complex and showed that complexation did not adversely affect the intrinsically high PZQ permeability (P app (PZQ)=(3.72±0.33)×10 -5 cms -1 and P app (PZQ/HPβCD)=(3.65±0.21)×10 -5 cms -1 ; p>0.05). All this confirmed that the co-grinding with the proper additive is as a promising strategy to improve biopharmaceutical properties of the drug. Copyright © 2017 Elsevier B.V. All rights reserved.

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.

Modified Mahalanobis Taguchi System for Imbalance Data Classification

Science.gov (United States)

2017-01-01

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). PMID:28811820

Nanoparticle formulation of a poorly soluble cannabinoid receptor 1 antagonist improves absorption by rat and human intestine

NARCIS (Netherlands)

Siissalo, Sanna; De Waard, Hans; De Jager, Marina H.; Hayeshi, Rose; Frijlink, Henderik W.; Hinrichs, Wouter L.J.; Dinter-Heidorn, Heike; Van Dam, Annie; Proost, Johannes H.; Groothuis, Geny M.M.; De Graaf, Inge A.M.

The inclusion of nanoparticles dispersed in a hydrophilic matrix is one of the formulation strategies to improve the bioavailability of orally administered Biopharmaceutics Classification System (BCS) class II and IV drugs by increasing their dissolution rate in the intestine. To confirm that the

Biowaiver monographs for immediate release solid oral dosage forms: acetaminophen (paracetamol).

NARCIS (Netherlands)

Kalantzi, L; Reppas, C; Dressman, J B; Amidon, G L; Junginger, H E; Midha, K K; Shah, V P; Stavchansky, S A; Barends, Dirk M

2006-01-01

Literature data are reviewed on the properties of acetaminophen (paracetamol) related to the biopharmaceutics classification system (BCS). According to the current BCS criteria, acetaminophen is BCS Class III compound. Differences in composition seldom, if ever, have an effect on the extent of

Biowaiver monographs for immediate release solid oral dosage forms: cimetidine.

NARCIS (Netherlands)

Jantratid, E; Prakongpan, S; Dressman, J B; Amidon, G L; Junginger, H E; Midha, K K; Barends, D M

2006-01-01

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing cimetidine are reviewed. According to the current Biopharmaceutics Classification System (BCS), cimetidine would be assigned

Nuclear power plant systems, structures and components and their safety classification

International Nuclear Information System (INIS)

2000-01-01

The assurance of a nuclear power plant's safety is based on the reliable functioning of the plant as well as on its appropriate maintenance and operation. To ensure the reliability of operation, special attention shall be paid to the design, manufacturing, commissioning and operation of the plant and its components. To control these functions the nuclear power plant is divided into structural and functional entities, i.e. systems. A systems safety class is determined by its safety significance. Safety class specifies the procedures to be employed in plant design, construction, monitoring and operation. The classification document contains all documentation related to the classification of the nuclear power plant. The principles of safety classification and the procedures pertaining to the classification document are presented in this guide. In the Appendix of the guide, examples of systems most typical of each safety class are given to clarify the safety classification principles

Novel approaches to vaginal delivery and safety of microbicides: biopharmaceuticals, nanoparticles, and vaccines.

Science.gov (United States)

Whaley, Kevin J; Hanes, Justin; Shattock, Robin; Cone, Richard A; Friend, David R

2010-12-01

The HIV-1 epidemic remains unchecked despite existing technology; vaccines and microbicides in development may help reverse the epidemic. Reverse transcriptase inhibitors (RTIs) formulated in gels tenofovir (TFV) and IVRs (dapivirine) are under clinical development. While TFV or similar products may prove successful for HIV-1, alternatives to RTIs may provide additional benefits, e.g., broader STI prevention. Biopharmaceutical agents under development as microbicides include cyanovirin, RANTES analogues, commensals, and Mabs. Cost of manufacturing biopharmaceuticals has been reduced and they can be formulated into tablets, films, and IVRs for vaginal delivery. Nanotechnology offers a novel approach to formulate microbicides potentially leading to uniform epithelial delivery. Delivery through vaginal mucus may be possible by controlling nanoparticle size and surface characteristics. Combining prevention modalities may be the most effective means of preventing STI transmission, importantly, codelivery of microbicides and vaccines has demonstrated. Finally, the safety of microbicide preparations and excipients commonly used can be assessed using a mouse/HSV-2 susceptibility model. Screening of new microbicide candidates and formulation excipients may avoid past issues of enhancing HIV-1 transmission. This article forms part of a special supplement covering several presentations on novel microbicide formulations from the symposium on "Recent Trends in Microbicide Formulations" held on 25 and 26 January 2010, Arlington, VA. Copyright © 2010 Elsevier B.V. All rights reserved.

In vitro disposition profiling of heterocyclic compounds.

Science.gov (United States)

Keemink, Janneke; Wuyts, Benjamin; Nicolaï, Johan; Jonghe, Steven De; Stella, Alessandro; Herdewijn, Piet; Augustijns, Patrick; Annaert, Pieter

2015-08-01

Compound libraries that are screened for biological activity commonly contain heterocycles. Besides potency, drug-like properties need to be evaluated to ensure in vivo efficacy of test compounds. In this context, we determined hepatic and intestinal disposition profiles for 17 heterocyclic compounds. All studied compounds showed rapid uptake in suspended rat hepatocytes, whereas metabolism was poor and the rate-limiting step in hepatic elimination. In vitro assays demonstrated a relatively low solubility and high intestinal permeability. Based on these in vitro data, heterocycles were categorized in the biopharmaceutics classification system (BCS) and the biopharmaceutics drug disposition classification system (BDDCS) to predict disposition characteristics before clinical data are available. Our findings emphasized the importance to use hepatocytes in addition to microsomes to study metabolism, since the latter lack non-microsomal enzymes and cellular context. Moreover, intracellular exposure should be considered to gain insight in the relevant fraction of the compound available at the enzymatic site. Finally, the study reveals discrepancies associated with the classification of heterocycles in BCS versus BDDCS. These probably originate from the binary character of both systems. Copyright © 2015 Elsevier B.V. All rights reserved.

Evaluation of Urinary Tract Dilation Classification System for Grading Postnatal Hydronephrosis.

Science.gov (United States)

Hodhod, Amr; Capolicchio, John-Paul; Jednak, Roman; El-Sherif, Eid; El-Doray, Abd El-Alim; El-Sherbiny, Mohamed

2016-03-01

We assessed the reliability and validity of the Urinary Tract Dilation classification system as a new grading system for postnatal hydronephrosis. We retrospectively reviewed charts of patients who presented with hydronephrosis from 2008 to 2013. We included patients diagnosed prenatally and those with hydronephrosis discovered incidentally during the first year of life. We excluded cases involving urinary tract infection, neurogenic bladder and chromosomal anomalies, those associated with extraurinary congenital malformations and those with followup of less than 24 months without resolution. Hydronephrosis was graded postnatally using the Society for Fetal Urology system, and then the management protocol was chosen. All units were regraded using the Urinary Tract Dilation classification system and compared to the Society for Fetal Urology system to assess reliability. Univariate and multivariate analyses were performed to assess the validity of the Urinary Tract Dilation classification system in predicting hydronephrosis resolution and surgical intervention. A total of 490 patients (730 renal units) were eligible to participate. The Urinary Tract Dilation classification system was reliable in the assessment of hydronephrosis (parallel forms 0.92). Hydronephrosis resolved in 357 units (49%), and 86 units (12%) were managed by surgical intervention. The remainder of renal units demonstrated stable or improved hydronephrosis. Multivariate analysis revealed that the likelihood of surgical intervention was predicted independently by Urinary Tract Dilation classification system risk group, while Society for Fetal Urology grades were predictive of likelihood of resolution. The Urinary Tract Dilation classification system is reliable for evaluation of postnatal hydronephrosis and is valid in predicting surgical intervention. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

A systematic literature review of automated clinical coding and classification systems.

Science.gov (United States)

Stanfill, Mary H; Williams, Margaret; Fenton, Susan H; Jenders, Robert A; Hersh, William R

2010-01-01

Clinical coding and classification processes transform natural language descriptions in clinical text into data that can subsequently be used for clinical care, research, and other purposes. This systematic literature review examined studies that evaluated all types of automated coding and classification systems to determine the performance of such systems. Studies indexed in Medline or other relevant databases prior to March 2009 were considered. The 113 studies included in this review show that automated tools exist for a variety of coding and classification purposes, focus on various healthcare specialties, and handle a wide variety of clinical document types. Automated coding and classification systems themselves are not generalizable, nor are the results of the studies evaluating them. Published research shows these systems hold promise, but these data must be considered in context, with performance relative to the complexity of the task and the desired outcome.

A new classification system for congenital laryngeal cysts.

Science.gov (United States)

Forte, Vito; Fuoco, Gabriel; James, Adrian

2004-06-01

A new classification system for congenital laryngeal cysts based on the extent of the cyst and on the embryologic tissue of origin is proposed. Retrospective chart review. The charts of 20 patients with either congenital or acquired laryngeal cysts that were treated surgically between 1987 and 2002 at the Hospital for Sick Children, Toronto were retrospectively reviewed. Clinical presentation, radiologic findings, surgical management, histopathology, and outcome were recorded. A new classification system is proposed to better appreciate the origin of these cysts and to guide in their successful surgical management. Fourteen of the supraglottic and subglottic simple mucous retention cysts posed no diagnostic or therapeutic challenge and were treated successfully by a single endoscopic excision or marsupialization. The remaining six patients with congenital cysts in the study were deemed more complex, and all required open surgical procedures for cure. On the basis of the analysis of the data of these patients, a new classification of congenital laryngeal cysts is proposed. Type I cysts are confined to the larynx, the cyst wall composed of endodermal elements only, and can be managed endoscopically. Type II cysts extend beyond the confines of the larynx and require an external approach. The Type II cysts are further subclassified histologically on the basis of the embryologic tissue of origin: IIa, composed of endoderm only and IIb, containing endodermal and mesodermal elements (epithelium and cartilage) in the wall of the cyst. A new classification system for congenital laryngeal cysts is proposed on the basis of the extent of the cyst and the embryologic tissue of origin. This classification can help guide the surgeon with initial management and help us better understand the origin of these cysts.

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

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.

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.

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.

[New International Classification of Chronic Pancreatitis (M-ANNHEIM multifactor classification system, 2007): principles, merits, and demerits].

Science.gov (United States)

Tsimmerman, Ia S

2008-01-01

The new International Classification of Chronic Pancreatitis (designated as M-ANNHEIM) proposed by a group of German specialists in late 2007 is reviewed. All its sections are subjected to analysis (risk group categories, clinical stages and phases, variants of clinical course, diagnostic criteria for "established" and "suspected" pancreatitis, instrumental methods and functional tests used in the diagnosis, evaluation of the severity of the disease using a scoring system, stages of elimination of pain syndrome). The new classification is compared with the earlier classification proposed by the author. Its merits and demerits are discussed.

Capacity planning for batch and perfusion bioprocesses across multiple biopharmaceutical facilities.

Science.gov (United States)

Siganporia, Cyrus C; Ghosh, Soumitra; Daszkowski, Thomas; Papageorgiou, Lazaros G; Farid, Suzanne S

2014-01-01

Production planning for biopharmaceutical portfolios becomes more complex when products switch between fed-batch and continuous perfusion culture processes. This article describes the development of a discrete-time mixed integer linear programming (MILP) model to optimize capacity plans for multiple biopharmaceutical products, with either batch or perfusion bioprocesses, across multiple facilities to meet quarterly demands. The model comprised specific features to account for products with fed-batch or perfusion culture processes such as sequence-dependent changeover times, continuous culture constraints, and decoupled upstream and downstream operations that permit independent scheduling of each. Strategic inventory levels were accounted for by applying cost penalties when they were not met. A rolling time horizon methodology was utilized in conjunction with the MILP model and was shown to obtain solutions with greater optimality in less computational time than the full-scale model. The model was applied to an industrial case study to illustrate how the framework aids decisions regarding outsourcing capacity to third party manufacturers or building new facilities. The impact of variations on key parameters such as demand or titres on the optimal production plans and costs was captured. The analysis identified the critical ratio of in-house to contract manufacturing organization (CMO) manufacturing costs that led the optimization results to favor building a future facility over using a CMO. The tool predicted that if titres were higher than expected then the optimal solution would allocate more production to in-house facilities, where manufacturing costs were lower. Utilization graphs indicated when capacity expansion should be considered. © 2014 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers.

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.

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.

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.

Bosniak Classification system

DEFF Research Database (Denmark)

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

2014-01-01

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....... Purpose: To investigate the inter- and intra-observer agreement among experienced uroradiologists when categorizing complex renal cysts according to the Bosniak classification. Material and Methods: The original categories of 100 cystic renal masses were chosen as “Gold Standard” (GS), established...... to the calculated weighted κ all readers performed “very good” for both inter-observer and intra-observer variation. Most variation was seen in cysts catagorized as Bosniak II, IIF, and III. These results show that radiologists who evaluate complex renal cysts routinely may apply the Bosniak classification...

Human Embryonic Kidney 293 Cells: A Vehicle for Biopharmaceutical Manufacturing, Structural Biology, and Electrophysiology.

Science.gov (United States)

Hu, Jianwen; Han, Jizhong; Li, Haoran; Zhang, Xian; Liu, Lan Lan; Chen, Fei; Zeng, Bin

2018-01-01

Mammalian cells, e.g., CHO, BHK, HEK293, HT-1080, and NS0 cells, represent important manufacturing platforms in bioengineering. They are widely used for the production of recombinant therapeutic proteins, vaccines, anticancer agents, and other clinically relevant drugs. HEK293 (human embryonic kidney 293) cells and their derived cell lines provide an attractive heterologous system for the development of recombinant proteins or adenovirus productions, not least due to their human-like posttranslational modification of protein molecules to provide the desired biological activity. Secondly, they also exhibit high transfection efficiency yielding high-quality recombinant proteins. They are easy to maintain and express with high fidelity membrane proteins, such as ion channels and transporters, and thus are attractive for structural biology and electrophysiology studies. In this article, we review the literature on HEK293 cells regarding their origins but also stress their advancements into the different cell lines engineered and discuss some significant aspects which make them versatile systems for biopharmaceutical manufacturing, drug screening, structural biology research, and electrophysiology applications. © 2018 S. Karger AG, Basel.

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...

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

A system for heart sounds classification.

Directory of Open Access Journals (Sweden)

Grzegorz Redlarski

Full Text Available The future of quick and efficient disease diagnosis lays in the development of reliable non-invasive methods. As for the cardiac diseases - one of the major causes of death around the globe - a concept of an electronic stethoscope equipped with an automatic heart tone identification system appears to be the best solution. Thanks to the advancement in technology, the quality of phonocardiography signals is no longer an issue. However, appropriate algorithms for auto-diagnosis systems of heart diseases that could be capable of distinguishing most of known pathological states have not been yet developed. The main issue is non-stationary character of phonocardiography signals as well as a wide range of distinguishable pathological heart sounds. In this paper a new heart sound classification technique, which might find use in medical diagnostic systems, is presented. It is shown that by combining Linear Predictive Coding coefficients, used for future extraction, with a classifier built upon combining Support Vector Machine and Modified Cuckoo Search algorithm, an improvement in performance of the diagnostic system, in terms of accuracy, complexity and range of distinguishable heart sounds, can be made. The developed system achieved accuracy above 93% for all considered cases including simultaneous identification of twelve different heart sound classes. The respective system is compared with four different major classification methods, proving its reliability.

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...

Measurement of semantic similarity for land use and land cover classification systems

Science.gov (United States)

Deng, Dongpo

2008-12-01

Land use and land cover (LULC) data is essential to environmental and ecological research. However, semantic heterogeneous of land use and land cover classification are often resulted from different data resources, different cultural contexts, and different utilities. Therefore, there is need to develop a method to measure, compare and integrate between land cover categories. To understand the meaning and the use of terminology from different domains, the common ontology approach is used to acquire information regarding the meaning of terms, and to compare two terms to determine how they might be related. Ontology is a formal specification of a shared conceptualization of a domain of interest. LULC classification system is a ontology. The semantic similarity method is used to compare to entities of three LULC classification systems: CORINE (European Environmental Agency), Oregon State, USA), and Taiwan. The semantic properties and relations firstly have been extracted from their definitions of LULC classification systems. Then semantic properties and relations of categories in three LULC classification systems are mutually compared. The visualization of semantic proximity is finally presented to explore the similarity or dissimilarity of data. This study shows the semantic similarity method efficiently detect semantic distance in three LULC classification systems and find out the semantic similar objects.

A comparison of the Web of Science with publication-level classification systems of science

Energy Technology Data Exchange (ETDEWEB)

Perianes-Rodriguez, A.; Ruiz-Castillo, J.

2016-07-01

In this paper we propose a new criterion for choosing between a pair of classification systems of science that assign publications (or journals) to a set of scientific fields. Consider the standard normalization procedure in which field mean citations are used as normalization factors. We recommend system A over system B whenever the standard normalization procedure based on A performs better than the when it is based on B. Since the evaluation can be made in terms of either system, the performance assessment requires a double test. In addition, since the assessment of two normalization procedures would be generally biased in favor of the one based on the classification system used for evaluation purposes, ideally a pair of classification systems must be compared using a third, independent classification system for evaluation purposes. We illustrate this strategy by comparing a Web of Science journal-level classification system, consisting of 236 journal subject categories, with two publication-level algorithmically constructed classification systems consisting of 1,363 (G6) and 5,119 (G8) clusters. There are two main findings. (1) The G8 system is found to dominate the G6 system. Therefore, when we have a choice between two classification systems at different granularity levels, we should use the system at the higher level because it typically exhibits a better standard normalization performance. (2) The G8 system and the Web of Science (WoS) journal-level system are found to be non-comparable. Nevertheless, the G8-normalization procedure performs better using the WoS system for evaluation purposes than the WoS-normalization procedure using the G8 system for evaluation purposes. Furthermore, when we use the G6 system for evaluation purposes, the G8-normalization procedure performs better than the WoS-normalization procedure. We conclude that algorithmically constructed classification systems constitute a credible alternative to the WoS system and, by extension, to

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.

Interrater reliability of a Pilates movement-based classification system.

Science.gov (United States)

Yu, Kwan Kenny; Tulloch, Evelyn; Hendrick, Paul

2015-01-01

To determine the interrater reliability for identification of a specific movement pattern using a Pilates Classification system. Videos of 5 subjects performing specific movement tasks were sent to raters trained in the DMA-CP classification system. Ninety-six raters completed the survey. Interrater reliability for the detection of a directional bias was excellent (Pi = 0.92, and K(free) = 0.89). Interrater reliability for classifying an individual into a specific subgroup was moderate (Pi = 0.64, K(free) = 0.55) however raters who had completed levels 1-4 of the DMA-CP training and reported using the assessment daily demonstrated excellent reliability (Pi = 0.89 and K(free) = 0.87). The reliability of the classification system demonstrated almost perfect agreement in determining the existence of a specific movement pattern and classifying into a subgroup for experienced raters. There was a trend for greater reliability associated with increased levels of training and experience of the raters. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

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

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)

Classification system of the mineral reserves and resources of Ukraine

International Nuclear Information System (INIS)

Lovyunikov, V.I.

1997-01-01

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 procedures 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 resources classification. The UN system is based on economics of production and mineability. (author). 1 tab

The history of female genital tract malformation classifications and proposal of an updated system.

Science.gov (United States)

Acién, Pedro; Acién, Maribel I

2011-01-01

A correct classification of malformations of the female genital tract is essential to prevent unnecessary and inadequate surgical operations and to compare reproductive results. An ideal classification system should be based on aetiopathogenesis and should suggest the appropriate therapeutic strategy. We conducted a systematic review of relevant articles found in PubMed, Scopus, Scirus and ISI webknowledge, and analysis of historical collections of 'female genital malformations' and 'classifications'. Of 124 full-text articles assessed for eligibility, 64 were included because they contained original general, partial or modified classifications. All the existing classifications were analysed and grouped. The unification of terms and concepts was also analysed. Traditionally, malformations of the female genital tract have been catalogued and classified as Müllerian malformations due to agenesis, lack of fusion, the absence of resorption and lack of posterior development of the Müllerian ducts. The American Fertility Society classification of the late 1980s included seven basic groups of malformations also considering the Müllerian development and the relationship of the malformations to fertility. Other classifications are based on different aspects: functional, defects in vertical fusion, embryological or anatomical (Vagina, Cervix, Uterus, Adnex and Associated Malformation: VCUAM classification). However, an embryological-clinical classification system seems to be the most appropriate. Accepting the need for a new classification system of genitourinary malformations that considers the experience gained from the application of the current classification systems, the aetiopathogenesis and that also suggests the appropriate treatment, we proposed an update of our embryological-clinical classification as a new system with six groups of female genitourinary anomalies.

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

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

Host Rock Classification (HRC) system for nuclear waste disposal in crystalline bedrock

International Nuclear Information System (INIS)

Hagros, A.

2006-01-01

A new rock mass classification scheme, the Host Rock Classification system (HRC-system) has been developed for evaluating the suitability of volumes of rock mass for the disposal of high-level nuclear waste in Precambrian crystalline bedrock. To support the development of the system, the requirements of host rock to be used for disposal have been studied in detail and the significance of the various rock mass properties have been examined. The HRC-system considers both the long-term safety of the repository and the constructability in the rock mass. The system is specific to the KBS-3V disposal concept and can be used only at sites that have been evaluated to be suitable at the site scale. By using the HRC-system, it is possible to identify potentially suitable volumes within the site at several different scales (repository, tunnel and canister scales). The selection of the classification parameters to be included in the HRC-system is based on an extensive study on the rock mass properties and their various influences on the long-term safety, the constructability and the layout and location of the repository. The parameters proposed for the classification at the repository scale include fracture zones, strength/stress ratio, hydraulic conductivity and the Groundwater Chemistry Index. The parameters proposed for the classification at the tunnel scale include hydraulic conductivity, Q' and fracture zones and the parameters proposed for the classification at the canister scale include hydraulic conductivity, Q', fracture zones, fracture width (aperture + filling) and fracture trace length. The parameter values will be used to determine the suitability classes for the volumes of rock to be classified. The HRC-system includes four suitability classes at the repository and tunnel scales and three suitability classes at the canister scale and the classification process is linked to several important decisions regarding the location and acceptability of many components of

Capacity Planning for Batch and Perfusion Bioprocesses Across Multiple Biopharmaceutical Facilities

Science.gov (United States)

Siganporia, Cyrus C; Ghosh, Soumitra; Daszkowski, Thomas; Papageorgiou, Lazaros G; Farid, Suzanne S

2014-01-01

Production planning for biopharmaceutical portfolios becomes more complex when products switch between fed-batch and continuous perfusion culture processes. This article describes the development of a discrete-time mixed integer linear programming (MILP) model to optimize capacity plans for multiple biopharmaceutical products, with either batch or perfusion bioprocesses, across multiple facilities to meet quarterly demands. The model comprised specific features to account for products with fed-batch or perfusion culture processes such as sequence-dependent changeover times, continuous culture constraints, and decoupled upstream and downstream operations that permit independent scheduling of each. Strategic inventory levels were accounted for by applying cost penalties when they were not met. A rolling time horizon methodology was utilized in conjunction with the MILP model and was shown to obtain solutions with greater optimality in less computational time than the full-scale model. The model was applied to an industrial case study to illustrate how the framework aids decisions regarding outsourcing capacity to third party manufacturers or building new facilities. The impact of variations on key parameters such as demand or titres on the optimal production plans and costs was captured. The analysis identified the critical ratio of in-house to contract manufacturing organization (CMO) manufacturing costs that led the optimization results to favor building a future facility over using a CMO. The tool predicted that if titres were higher than expected then the optimal solution would allocate more production to in-house facilities, where manufacturing costs were lower. Utilization graphs indicated when capacity expansion should be considered. © 2013 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers Biotechnol. Prog., 30:594–606, 2014 PMID:24376262

A proposal of criteria for the classification of systemic sclerosis.

Science.gov (United States)

Nadashkevich, Oleg; Davis, Paul; Fritzler, Marvin J

2004-11-01

Sensitive and specific criteria for the classification of systemic sclerosis are required by clinicians and investigators to achieve higher quality clinical studies and approaches to therapy. A clinical study of systemic sclerosis patients in Europe and Canada led to a set of criteria that achieve high sensitivity and specificity. Both clinical and laboratory investigations of patients with systemic sclerosis, related conditions and diseases with clinical features that can be mistaken as part of the systemic sclerosis spectrum were undertaken. Laboratory investigations included the detection of autoantibodies to centromere proteins, Scl-70 (topoisomerase I), and fibrillarin (U3-RNP). Based on the investigation of 269 systemic sclerosis patients and 720 patients presenting with related and confounding conditions, the following set of criteria for the classification of systemic sclerosis was proposed: 1) autoantibodies to: centromere proteins, Scl-70 (topo I), fibrillarin; 2) bibasilar pulmonary fibrosis; 3) contractures of the digital joints or prayer sign; 4) dermal thickening proximal to the wrists; 5) calcinosis cutis; 6) Raynaud's phenomenon; 7) esophageal distal hypomotility or reflux-esophagitis; 8) sclerodactyly or non-pitting digital edema; 9) teleangiectasias. The classification of definite SSc requires at least three of the above criteria. Criteria for the classification of systemic sclerosis have been proposed. Preliminary testing has defined the sensitivity and specificity of these criteria as high as 99% and 100%, respectively. Testing and validation of the proposed criteria by other clinical centers is required.

A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design.

Science.gov (United States)

Martin-Moe, Sheryl; Lim, Fredric J; Wong, Rita L; Sreedhara, Alavattam; Sundaram, Jagannathan; Sane, Samir U

2011-08-01

Quality by design (QbD) is a science- and risk-based approach to drug product development. Although pharmaceutical companies have historically used many of the same principles during development, this knowledge was not always formally captured or proactively submitted to regulators. In recent years, the US Food and Drug Administration has also recognized the need for more controls in the drug manufacturing processes, especially for biological therapeutics, and it has recently launched an initiative for Pharmaceutical Quality for the 21st Century to modernize pharmaceutical manufacturing and improve product quality. In the biopharmaceutical world, the QbD efforts have been mainly focused on active pharmaceutical ingredient processes with little emphasis on drug product development. We present a systematic approach to biopharmaceutical drug product development using a monoclonal antibody as an example. The approach presented herein leverages scientific understanding of products and processes, risk assessments, and rational experimental design to deliver processes that are consistent with QbD philosophy without excessive incremental effort. Data generated using these approaches will not only strengthen data packages to support specifications and manufacturing ranges but hopefully simplify implementation of postapproval changes. We anticipate that this approach will positively impact cost for companies, regulatory agencies, and patients, alike. Copyright © 2011 Wiley-Liss, Inc.

Classification system for acute and chronic radiation treatment sequelae

International Nuclear Information System (INIS)

Seegenschmiedt, M.H.; Sauer, R.

1993-01-01

A classification system in German language is proposed for scoring of acute and chronic treatment sequelae after radiotherapy. It includes all important organs and organ systems. The proposed grading corresponds to the four-scale-system of the WHO and UICC. The system is also compatible to the RTOG and EORTC acute and late radiation morbidity scoring criteria. This facilitates the data transfer for retrospective and prospective analysis of monomodal and multimodal radiotherapy treatment regimes. We recommend to use this scoring system in all German speaking countries for multicentric prospective studies. It is possible, that organ-specific sophistications of the toxicity grading will be developed in the future. These additions should conform with (inter)national standards and apply the same four-scale grading of this classification system. (orig.) [de

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

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

Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium

NARCIS (Netherlands)

Rup, B.; Pallardy, M.; Sikkema, D.; Albert, T.; Allez, M.; Broet, P.; Carini, C.; Creeke, P.; Davidson, J.; de Vries, N. [=Niek; Finco, D.; Fogdell-Hahn, A.; Havrdova, E.; Hincelin-Mery, A.; C Holland, M.; H Jensen, P. E.; Jury, E. C.; Kirby, H.; Kramer, D.; Lacroix-Desmazes, S.; Legrand, J.; Maggi, E.; Maillère, B.; Mariette, X.; Mauri, C.; Mikol, V.; Mulleman, D.; Oldenburg, J.; Paintaud, G.; R Pedersen, C.; Ruperto, N.; Seitz, R.; Spindeldreher, S.; Deisenhammer, F.

2015-01-01

Biopharmaceuticals (BPs) represent a rapidly growing class of approved and investigational drug therapies that is contributing significantly to advancing treatment in multiple disease areas, including inflammatory and autoimmune diseases, genetic deficiencies and cancer. Unfortunately, unwanted

On safety classification of instrumentation and control systems and their components

International Nuclear Information System (INIS)

Yastrebenetskij, M.A.; Rozen, Yu.V.

2004-01-01

Safety classification of instrumentation and control systems (I and C) and their components (hardware, software, software-hardware complexes) is described: - evaluation of classification principles and criteria in Ukrainian standards and rules; comparison between Ukrainian and international principles and criteria; possibility and ways of coordination of Ukrainian and international standards related to (I and C) safety classification

Evaluation of the physicochemical and biopharmaceutical properties of fluoro-indomethacin.

Science.gov (United States)

Mori, Michela M; Airaksinen, Anu J; Hirvonen, Jouni T; Santos, Hélder A; Caramella, Carla M

2013-01-01

Drug nanocarriers have shown great potential in therapy and as diagnostic probes, e.g. in imaging of cancer and inflammation. Imaging can be applied to localize the carrier or the drug itself in the body and/or tissues. In this particular case it is important that drug molecules have the characteristics for possible detection, e.g. after modification with positron emission tomography compliant radioisotopes, without affecting their pharmacological behavior. In order to easily and efficiently follow the ADME profile of the drug after loaded into nanocarriers, the drug can be radiolabelled with, e.g. 18F-label, in order to assess its biodistribution after enteral and parenteral administration in rats. However, this is only possible if the derivative compound behaves similarly to the parent drug compound. In this study, indomethacin (a poorly water-soluble drug) was chosen as a model compound and aimed to evaluate the physicochemical and biopharmaceutical properties of an analog of indomethacin (IMC), fluoro-indomethacin (F-IMC). Although some of the physicochemical and biopharmaceutical properties of IMC are already known, in order to establish a feasible comparison between IMC and F-IMC, the behavior of the former was also investigated in the same conditions as for F-IMC. In this context, both IMC and F-IMC were thermally and morphologically studied. Furthermore, the following properties were also studied for both compounds: pKa and logP, solubility and dissolution profiles at physiological pH values, and toxicity at different concentrations in Caco-2 cells. Finally, the transport across Caco- 2 monolayers of the IMC and F-IMC at physiological pH range was also investigated. The results obtained showed similar values in pKalogP, solubility, dissolution, cytotoxicity, and permeability for both compounds. Thus, there might be strong evidence that both IMC and F-IMC should have a similar ADME behavior and profiles in vivo. The results provide fundamental tools and

Managing Risk to the Patient: Recoding Quality Risk Management for the Pharmaceutical and Biopharmaceutical Industries

OpenAIRE

Waldron, Kelly

2017-01-01

This thesis explores the application of quality risk management (QRM) in pharmaceutical and biopharmaceutical companies and its effectiveness at managing risk to the patient. The objective of the research described in this thesis was to characterize a maturity state of QRM implementation in which the patient is adequately protected from the risks associated with medicinal products of inadequate quality. The research was conducted over three phases: first, to determine whether patients are bet...

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.

Microtools for single-cell analysis in biopharmaceutical development and manufacturing.

Science.gov (United States)

Love, Kerry Routenberg; Bagh, Sangram; Choi, Jonghoon; Love, J Christopher

2013-05-01

Biologic drugs are promoting growth in the biopharmaceutical industry. Despite the clinical benefits of these drugs, the time and costs required to bring new biologics to market still are substantial. Three key challenges, among others, persist in the development of biologic drugs: namely, establishing product similarity, product toxicity, and global accessibility. New classes of microtools that facilitate the isolation and interrogation of single cells have the potential to impact each of these challenges. This opinion considers recent examples of microtools with demonstrated or potential utility to address problems in these areas. Integrating these advanced technologies into the development of new biologics could greatly reduce time and costs required to bring alternative products to market, and thus expand their global availability. Copyright © 2013 Elsevier Ltd. All rights reserved.

Validation of a new classification system for interprosthetic femoral fractures.

Science.gov (United States)

Pires, Robinson Esteves Santos; Silveira, Marcelo Peixoto Sena; Resende, Alessandra Regina da Silva; Junior, Egidio Oliveira Santana; Campos, Tulio Vinicius Oliveira; Santos, Leandro Emilio Nascimento; Balbachevsky, Daniel; Andrade, Marco Antônio Percope de

2017-07-01

Interprosthetic femoral fracture (IFF) incidence is gradually increasing as the population is progressively ageing. However, treatment remains challenging due to several contributing factors, such as poor bone quality, patient comorbidities, small interprosthetic fragment, and prostheses instability. An effective and specific classification system is essential to optimize treatment management, therefore diminishing complication rates. This study aims to validate a previously described classification system for interprosthetic femoral fractures. Copyright © 2017 Elsevier Ltd. All rights reserved.

Aspects of research and development contract terms in the bio/pharmaceutical sector.

Science.gov (United States)

Banerjee, Tannista

2012-01-01

The cost of new drug development is increasing every year. Pharmaceutical companies use R&D joint ventures, mergers, and outsource different stages of pharmaceutical R&D activities for a faster and cost minimizing method of innovation. Pharmaceutical companies outsource R&D activities to independent small biotech or pharmaceutical companies that specialize in different stages of pharmaceutical R&D. This chapter examines the determinants of the payment structure of research contracts between large bio/pharmaceutical companies and specialized research firms. Determinants of R&D contracts are analyzed using detailed R&D contract data between bio/pharmaceutical companies and independent research firms for 10 years. A multinomial logit model is used in order to understand the determinants of three different types of contracts; royalty contracts, fixed payment contracts, and the mixed contracts. Under uncertainty, the likelihood of a royalty contract rises for the early stages of the research and with the patent stock of the research firm. It is more likely to observe both royalty and fixed payment if the pharmaceutical client has past contracts with the same research firm. The results also suggest that if Food and Drug Administration (FDA) is more stringent in any disease area in reviewing the new drug application, then the likelihood of signing pure royalty contract decreases. Understanding the nature of R&D contracts and the effects of FDA's behavior on the pharmaceutical R&D contract is important because these contracts not only affect the cost of new drug invention but also the quality and the rate of invention. VALUE: Results are useful for both the pharmaceutical companies and the economic/business researchers.

Cognitive-motivational deficits in ADHD: development of a classification system.

Science.gov (United States)

Gupta, Rashmi; Kar, Bhoomika R; Srinivasan, Narayanan

2011-01-01

The classification systems developed so far to detect attention deficit/hyperactivity disorder (ADHD) do not have high sensitivity and specificity. We have developed a classification system based on several neuropsychological tests that measure cognitive-motivational functions that are specifically impaired in ADHD children. A total of 240 (120 ADHD children and 120 healthy controls) children in the age range of 6-9 years and 32 Oppositional Defiant Disorder (ODD) children (aged 9 years) participated in the study. Stop-Signal, Task-Switching, Attentional Network, and Choice Delay tests were administered to all the participants. Receiver operating characteristic (ROC) analysis indicated that percentage choice of long-delay reward best classified the ADHD children from healthy controls. Single parameters were not helpful in making a differential classification of ADHD with ODD. Multinominal logistic regression (MLR) was performed with multiple parameters (data fusion) that produced improved overall classification accuracy. A combination of stop-signal reaction time, posterror-slowing, mean delay, switch cost, and percentage choice of long-delay reward produced an overall classification accuracy of 97.8%; with internal validation, the overall accuracy was 92.2%. Combining parameters from different tests of control functions not only enabled us to accurately classify ADHD children from healthy controls but also in making a differential classification with ODD. These results have implications for the theories of ADHD.

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

78 FR 18252 - Prevailing Rate Systems; North American Industry Classification System Based Federal Wage System...

Science.gov (United States)

2013-03-26

...-AM78 Prevailing Rate Systems; North American Industry Classification System Based Federal Wage System... applicable sections. The Federal Prevailing Rate Advisory Committee, the national labor- management committee... proposing to amend 5 CFR part 532 as follows: PART 532--PREVAILING RATE SYSTEMS 0 1. The authority citation...

Microencapsulation for the Therapeutic Delivery of Drugs, Live Mammalian and Bacterial Cells, and Other Biopharmaceutics: Current Status and Future Directions

Directory of Open Access Journals (Sweden)

Catherine Tomaro-Duchesneau

2013-01-01

Full Text Available Microencapsulation is a technology that has shown significant promise in biotherapeutics, and other applications. It has been proven useful in the immobilization of drugs, live mammalian and bacterial cells and other cells, and other biopharmaceutics molecules, as it can provide material structuration, protection of the enclosed product, and controlled release of the encapsulated contents, all of which can ensure efficient and safe therapeutic effects. This paper is a comprehensive review of microencapsulation and its latest developments in the field. It provides a comprehensive overview of the technology and primary goals of microencapsulation and discusses various processes and techniques involved in microencapsulation including physical, chemical, physicochemical, and other methods involved. It also summarizes the state-of-the-art successes of microencapsulation, specifically with regard to the encapsulation of microorganisms, mammalian cells, drugs, and other biopharmaceutics in various diseases. The limitations and future directions of microencapsulation technologies are also discussed.

Microencapsulation for the Therapeutic Delivery of Drugs, Live Mammalian and Bacterial Cells, and Other Biopharmaceutics: Current Status and Future Directions

Science.gov (United States)

Saha, Shyamali; Malhotra, Meenakshi; Kahouli, Imen; Prakash, Satya

2013-01-01

Microencapsulation is a technology that has shown significant promise in biotherapeutics, and other applications. It has been proven useful in the immobilization of drugs, live mammalian and bacterial cells and other cells, and other biopharmaceutics molecules, as it can provide material structuration, protection of the enclosed product, and controlled release of the encapsulated contents, all of which can ensure efficient and safe therapeutic effects. This paper is a comprehensive review of microencapsulation and its latest developments in the field. It provides a comprehensive overview of the technology and primary goals of microencapsulation and discusses various processes and techniques involved in microencapsulation including physical, chemical, physicochemical, and other methods involved. It also summarizes the state-of-the-art successes of microencapsulation, specifically with regard to the encapsulation of microorganisms, mammalian cells, drugs, and other biopharmaceutics in various diseases. The limitations and future directions of microencapsulation technologies are also discussed. PMID:26555963

Gender classification system in uncontrolled environments

Science.gov (United States)

Zeng, Pingping; Zhang, Yu-Jin; Duan, Fei

2011-01-01

Most face analysis systems available today perform mainly on restricted databases of images in terms of size, age, illumination. In addition, it is frequently assumed that all images are frontal and unconcealed. Actually, in a non-guided real-time supervision, the face pictures taken may often be partially covered and with head rotation less or more. In this paper, a special system supposed to be used in real-time surveillance with un-calibrated camera and non-guided photography is described. It mainly consists of five parts: face detection, non-face filtering, best-angle face selection, texture normalization, and gender classification. Emphases are focused on non-face filtering and best-angle face selection parts as well as texture normalization. Best-angle faces are figured out by PCA reconstruction, which equals to an implicit face alignment and results in a huge increase of the accuracy for gender classification. Dynamic skin model and a masked PCA reconstruction algorithm are applied to filter out faces detected in error. In order to fully include facial-texture and shape-outline features, a hybrid feature that is a combination of Gabor wavelet and PHoG (pyramid histogram of gradients) was proposed to equitable inner texture and outer contour. Comparative study on the effects of different non-face filtering and texture masking methods in the context of gender classification by SVM is reported through experiments on a set of UT (a company name) face images, a large number of internet images and CAS (Chinese Academy of Sciences) face database. Some encouraging results are obtained.

The Spinal Cord Injury-Interventions Classification System

NARCIS (Netherlands)

van Langeveld, A.H.B.

2010-01-01

Title: The Spinal Cord Injury-Interventions Classification System: development and evaluation of a documentation tool to record therapy to improve mobility and self-care in people with spinal cord injury. Background: Many rehabilitation researchers have emphasized the need to examine the actual

Classification of Metal-Deficient Dwarfs in the Vilnius Photometric System

Directory of Open Access Journals (Sweden)

Lazauskaitė R.

2003-12-01

Full Text Available Methods used for the quantitative classification of metal-deficient stars in the Vilnius photometric system are reviewed. We present a new calibration of absolute magnitudes for dwarfs and subdwarfs, based on Hipparcos parallaxes. The new classification scheme is applied to a sample of Population II visual binaries.

Ion-exchange chromatography for the characterization of biopharmaceuticals.

Science.gov (United States)

Fekete, Szabolcs; Beck, Alain; Veuthey, Jean-Luc; Guillarme, Davy

2015-09-10

Ion-exchange chromatography (IEX) is a historical technique widely used for the detailed characterization of therapeutic proteins and can be considered as a reference and powerful technique for the qualitative and quantitative evaluation of charge heterogeneity. The goal of this review is to provide an overview of theoretical and practical aspects of modern IEX applied for the characterization of therapeutic proteins including monoclonal antibodies (Mabs) and antibody drug conjugates (ADCs). The section on method development describes how to select a suitable stationary phase chemistry and dimensions, the mobile phase conditions (pH, nature and concentration of salt), as well as the temperature and flow rate, considering proteins isoelectric point (pI). In addition, both salt-gradient and pH-gradient approaches were critically reviewed and benefits as well as limitations of these two strategies were provided. Finally, several applications, mostly from pharmaceutical industries, illustrate the potential of IEX for the characterization of charge variants of various types of biopharmaceutical products. Copyright © 2015 Elsevier B.V. All rights reserved.

Categorization of intraoperative ureteroscopy complications using modified Satava classification system.

Science.gov (United States)

Tepeler, Abdulkadir; Resorlu, Berkan; Sahin, Tolga; Sarikaya, Selcuk; Bayindir, Mirze; Oguz, Ural; Armagan, Abdullah; Unsal, Ali

2014-02-01

To review our experience with ureteroscopy (URS) in the treatment of ureteral calculi and stratify intraoperative complications of URS according to the modified Satava classification system. We performed a retrospective analysis of 1,208 patients (672 males and 536 females), with a mean age of 43.1 years (range 1-78), who underwent ureteroscopic procedures for removal of ureteral stones. Intraoperative complications were recorded according to modified Satava classification system. Grade 1 complications included incidents without consequences for the patient; grade 2 complications, which are treated intraoperatively with endoscopic surgery (grade 2a) or required endoscopic re-treatment (grade 2b); and grade 3 complications included incidents requiring open or laparoscopic surgery. The stones were completely removed in 1,067 (88.3%) patients after primary procedure by either simple extraction or after fragmentation. The overall incidence of intraoperative complications was 12.6%. The most common complications were proximal stone migration (3.9%), mucosal injury (2.8%), bleeding (1.9%), inability to reach stone (1.8%), malfunctioning or breakage of instruments (0.8%), ureteral perforation (0.8%) and ureteral avulsion (0.16%). According to modified Satava classification system, there were 4.5% grade 1; 4.4% grade 2a; 3.2% grade 2b; and 0.57% grade 3 complications. We think that modified Satava classification is a quick and simple system for describing the severity of intraoperative URS complications and this grading system will facilitate a better comparison for the surgical outcomes obtained from different centers.

A Preliminary Study on the Multiple Mapping Structure of Classification Systems for Heterogeneous Databases

Directory of Open Access Journals (Sweden)

Seok-Hyoung Lee

2012-06-01

Full Text Available While science and technology information service portals and heterogeneous databases produced in Korea and other countries are integrated, methods of connecting the unique classification systems applied to each database have been studied. Results of technologists' research, such as, journal articles, patent specifications, and research reports, are organically related to each other. In this case, if the most basic and meaningful classification systems are not connected, it is difficult to achieve interoperability of the information and thus not easy to implement meaningful science technology information services through information convergence. This study aims to address the aforementioned issue by analyzing mapping systems between classification systems in order to design a structure to connect a variety of classification systems used in the academic information database of the Korea Institute of Science and Technology Information, which provides science and technology information portal service. This study also aims to design a mapping system for the classification systems to be applied to actual science and technology information services and information management systems.

Advances in industrial biopharmaceutical batch process monitoring: Machine-learning methods for small data problems.

Science.gov (United States)

Tulsyan, Aditya; Garvin, Christopher; Ündey, Cenk

2018-04-06

Biopharmaceutical manufacturing comprises of multiple distinct processing steps that require effective and efficient monitoring of many variables simultaneously in real-time. The state-of-the-art real-time multivariate statistical batch process monitoring (BPM) platforms have been in use in recent years to ensure comprehensive monitoring is in place as a complementary tool for continued process verification to detect weak signals. This article addresses a longstanding, industry-wide problem in BPM, referred to as the "Low-N" problem, wherein a product has a limited production history. The current best industrial practice to address the Low-N problem is to switch from a multivariate to a univariate BPM, until sufficient product history is available to build and deploy a multivariate BPM platform. Every batch run without a robust multivariate BPM platform poses risk of not detecting potential weak signals developing in the process that might have an impact on process and product performance. In this article, we propose an approach to solve the Low-N problem by generating an arbitrarily large number of in silico batches through a combination of hardware exploitation and machine-learning methods. To the best of authors' knowledge, this is the first article to provide a solution to the Low-N problem in biopharmaceutical manufacturing using machine-learning methods. Several industrial case studies from bulk drug substance manufacturing are presented to demonstrate the efficacy of the proposed approach for BPM under various Low-N scenarios. © 2018 Wiley Periodicals, Inc.

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.

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…

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...

78 FR 58153 - Prevailing Rate Systems; North American Industry Classification System Based Federal Wage System...

Science.gov (United States)

2013-09-23

... American Industry Classification System Based Federal Wage System Wage Surveys AGENCY: U.S. Office of... in Federal Wage System wage survey industry regulations with the 2012 NAICS revisions published by.... Applicability date: This rule applies for local wage surveys beginning on or after February 21, 2014. FOR...

Cell-Penetrating Peptides as Carriers for Oral Delivery of Biopharmaceuticals

DEFF Research Database (Denmark)

Kristensen, Mie; Nielsen, Hanne Mørck

2016-01-01

Oral delivery of biopharmaceuticals, for example peptides and proteins, constitutes a great challenge in drug delivery due to their low chemical stability and poor permeation across the intestinal mucosa, to a large extent limiting the mode of administration to injections, which is not favouring...... patient compliance. Nevertheless, cell-penetrating peptides (CPPs) have shown promising potential as carriers to overcome the epithelium, and this minireview highlights recent knowledge gained within the field of CPP-mediated transepithelial delivery of therapeutic peptides and proteins from the intestine...... is to be preferred depends on the physicochemical properties of both the specific CPP and the specific cargo. In addition to the physical epithelial barrier, a metabolic barrier must be overcome in order to obtain CPP-mediated delivery of a cargo drug from the intestine, and a number of strategies have been employed...

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...

Virtual Sensor of Surface Electromyography in a New Extensive Fault-Tolerant Classification System.

Science.gov (United States)

de Moura, Karina de O A; Balbinot, Alexandre

2018-05-01

A few prosthetic control systems in the scientific literature obtain pattern recognition algorithms adapted to changes that occur in the myoelectric signal over time and, frequently, such systems are not natural and intuitive. These are some of the several challenges for myoelectric prostheses for everyday use. The concept of the virtual sensor, which has as its fundamental objective to estimate unavailable measures based on other available measures, is being used in other fields of research. The virtual sensor technique applied to surface electromyography can help to minimize these problems, typically related to the degradation of the myoelectric signal that usually leads to a decrease in the classification accuracy of the movements characterized by computational intelligent systems. This paper presents a virtual sensor in a new extensive fault-tolerant classification system to maintain the classification accuracy after the occurrence of the following contaminants: ECG interference, electrode displacement, movement artifacts, power line interference, and saturation. The Time-Varying Autoregressive Moving Average (TVARMA) and Time-Varying Kalman filter (TVK) models are compared to define the most robust model for the virtual sensor. Results of movement classification were presented comparing the usual classification techniques with the method of the degraded signal replacement and classifier retraining. The experimental results were evaluated for these five noise types in 16 surface electromyography (sEMG) channel degradation case studies. The proposed system without using classifier retraining techniques recovered of mean classification accuracy was of 4% to 38% for electrode displacement, movement artifacts, and saturation noise. The best mean classification considering all signal contaminants and channel combinations evaluated was the classification using the retraining method, replacing the degraded channel by the virtual sensor TVARMA model. This method

42 CFR 419.31 - Ambulatory payment classification (APC) system and payment weights.

Science.gov (United States)

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Ambulatory payment classification (APC) system and... Outpatient Services § 419.31 Ambulatory payment classification (APC) system and payment weights. (a) APC... of resource use into APC groups. Except as specified in paragraph (a)(2) of this section, items and...

Dynamic classification system in large-scale supervision of energy efficiency in buildings

International Nuclear Information System (INIS)

Kiluk, S.

2014-01-01

Highlights: • Rough set approximation of classification improves energy efficiency prediction. • Dynamic features of diagnostic classification allow for its precise prediction. • Indiscernibility in large population enhances identification of process features. • Diagnostic information can be refined by dynamic references to local neighbourhood. • We introduce data exploration validation based on system dynamics and uncertainty. - Abstract: Data mining and knowledge discovery applied to the billing data provide the diagnostic instruments for the evaluation of energy use in buildings connected to a district heating network. To ensure the validity of an algorithm-based classification system, the dynamic properties of a sequence of partitions for consecutive detected events were investigated. The information regarding the dynamic properties of the classification system refers to the similarities between the supervised objects and migrations that originate from the changes in the building energy use and loss similarity to their neighbourhood and thus represents the refinement of knowledge. In this study, we demonstrate that algorithm-based diagnostic knowledge has dynamic properties that can be exploited with a rough set predictor to evaluate whether the implementation of classification for supervision of energy use aligns with the dynamics of changes of district heating-supplied building properties. Moreover, we demonstrate the refinement of the current knowledge with the previous findings and we present the creation of predictive diagnostic systems based on knowledge dynamics with a satisfactory level of classification errors, even for non-stationary data

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.

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.

A Classification Framework for Large-Scale Face Recognition Systems

OpenAIRE

Zhou, Ziheng; Deravi, Farzin

2009-01-01

This paper presents a generic classification framework for large-scale face recognition systems. Within the framework, a data sampling strategy is proposed to tackle the data imbalance when image pairs are sampled from thousands of face images for preparing a training dataset. A modified kernel Fisher discriminant classifier is proposed to make it computationally feasible to train the kernel-based classification method using tens of thousands of training samples. The framework is tested in an...

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.

Correlation of the Rock Mass Rating (RMR) System with the Unified Soil Classification System (USCS): Introduction of the Weak Rock Mass Rating System (W-RMR)

Science.gov (United States)

Warren, Sean N.; Kallu, Raj R.; Barnard, Chase K.

2016-11-01

Underground gold mines in Nevada are exploiting increasingly deeper ore bodies comprised of weak to very weak rock masses. The Rock Mass Rating (RMR) classification system is widely used at underground gold mines in Nevada and is applicable in fair to good-quality rock masses, but is difficult to apply and loses reliability in very weak rock mass to soil-like material. Because very weak rock masses are transition materials that border engineering rock mass and soil classification systems, soil classification may sometimes be easier and more appropriate to provide insight into material behavior and properties. The Unified Soil Classification System (USCS) is the most likely choice for the classification of very weak rock mass to soil-like material because of its accepted use in tunnel engineering projects and its ability to predict soil-like material behavior underground. A correlation between the RMR and USCS systems was developed by comparing underground geotechnical RMR mapping to laboratory testing of bulk samples from the same locations, thereby assigning a numeric RMR value to the USCS classification that can be used in spreadsheet calculations and geostatistical analyses. The geotechnical classification system presented in this paper including a USCS-RMR correlation, RMR rating equations, and the Geo-Pick Strike Index is collectively introduced as the Weak Rock Mass Rating System (W-RMR). It is the authors' hope that this system will aid in the classification of weak rock masses and more usable design tools based on the RMR system. More broadly, the RMR-USCS correlation and the W-RMR system help define the transition between engineering soil and rock mass classification systems and may provide insight for geotechnical design in very weak rock masses.

Efficacy measures associated to a plantar pressure based classification system in diabetic foot medicine.

Science.gov (United States)

Deschamps, Kevin; Matricali, Giovanni Arnoldo; Desmet, Dirk; Roosen, Philip; Keijsers, Noel; Nobels, Frank; Bruyninckx, Herman; Staes, Filip

2016-09-01

The concept of 'classification' has, similar to many other diseases, been found to be fundamental in the field of diabetic medicine. In the current study, we aimed at determining efficacy measures of a recently published plantar pressure based classification system. Technical efficacy of the classification system was investigated by applying a high resolution, pixel-level analysis on the normalized plantar pressure pedobarographic fields of the original experimental dataset consisting of 97 patients with diabetes and 33 persons without diabetes. Clinical efficacy was assessed by considering the occurence of foot ulcers at the plantar aspect of the forefoot in this dataset. Classification efficacy was assessed by determining the classification recognition rate as well as its sensitivity and specificity using cross-validation subsets of the experimental dataset together with a novel cohort of 12 patients with diabetes. Pixel-level comparison of the four groups associated to the classification system highlighted distinct regional differences. Retrospective analysis showed the occurence of eleven foot ulcers in the experimental dataset since their gait analysis. Eight out of the eleven ulcers developed in a region of the foot which had the highest forces. Overall classification recognition rate exceeded 90% for all cross-validation subsets. Sensitivity and specificity of the four groups associated to the classification system exceeded respectively the 0.7 and 0.8 level in all cross-validation subsets. The results of the current study support the use of the novel plantar pressure based classification system in diabetic foot medicine. It may particularly serve in communication, diagnosis and clinical decision making. Copyright © 2016 Elsevier B.V. All rights reserved.

Mini review: Recombinant production of tailored bio-pharmaceuticals in different Bacillus strains and future perspectives.

Science.gov (United States)

Lakowitz, Antonia; Godard, Thibault; Biedendieck, Rebekka; Krull, Rainer

2018-05-01

Bio-pharmaceuticals like antibodies, hormones and growth factors represent about one-fifth of commercial pharmaceuticals. Host candidates of growing interest for recombinant production of these proteins are strains of the genus Bacillus, long being established for biotechnological production of homologous and heterologous proteins. Bacillus strains benefit from development of efficient expression systems in the last decades and emerge as major industrial workhorses for recombinant proteins due to easy cultivation, non-pathogenicity and their ability to secrete recombinant proteins directly into extracellular medium allowing cost-effective downstream processing. Their broad product portfolio of pharmaceutically relevant recombinant proteins described in research include antibody fragments, growth factors, interferons and interleukins, insulin, penicillin G acylase, streptavidin and different kinases produced in various cultivation systems like microtiter plates, shake flasks and bioreactor systems in batch, fed-batch and continuous mode. To further improve production and secretion performance of Bacillus, bottlenecks and limiting factors concerning proteases, chaperones, secretion machinery or feedback mechanisms can be identified on different cell levels from genomics and transcriptomics via proteomics to metabolomics and fluxomics. For systematical identification of recurring patterns characteristic of given regulatory systems and key genetic targets, systems biology and omics-technology provide suitable and promising approaches, pushing Bacillus further towards industrial application for recombinant pharmaceutical protein production. Copyright © 2017. Published by Elsevier B.V.

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.

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...

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...

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)

Classification of the MGR Assembly Transfer 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) assembly transfer 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)

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)

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)

CLASSIFICATION OF THE MGR OFFSITE UTILITIES 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) offsite utilities 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)

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)

Hand eczema classification

DEFF Research Database (Denmark)

Diepgen, T L; Andersen, Klaus Ejner; Brandao, F M

2008-01-01

of the disease is rarely evidence based, and a classification system for different subdiagnoses of hand eczema is not agreed upon. Randomized controlled trials investigating the treatment of hand eczema are called for. For this, as well as for clinical purposes, a generally accepted classification system...... A classification system for hand eczema is proposed. Conclusions It is suggested that this classification be used in clinical work and in clinical trials....

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.

Pharmacokinetic and biopharmaceutic aspects of some psoralen derivatives used in dermatology

International Nuclear Information System (INIS)

Stolk, L.M.L.

1982-01-01

In the present thesis the pharmacokinetic and biopharmaceutic properties of some psoralen derivatives, that are used in photochemotherapy of dermatological diseases like vitiligo and psoriasis, are studied. Photochemotherapy is a combination of oral administration of one of the psoralen derivatives, 8-methoxypsoralen (8-MOP), 5-methoxypsoralen (5-MOP) or 4, 5', 8-trimethylpsoralen (TMP), and irradiation with long wave ultraviolet light, U.V.-A (320-400 nm), two hours later. This treatment is commonly called PUVA (Psoralen-UV-A). The purpose of the investigation was to develop an 8-MOP dosage form with a fast and reproducible absorption. Various dosage forms of 8-MOP were administered to volunteers and patients and 8-MOP concentrations in body fluids determined. Also the pharmacokinetic properties of 5-MOP and TMP were investigated in a pilot study. (Auth.)

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.

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)

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)

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.

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.

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.

Science.gov (United States)

Hofsäss, Martin A; Souza, Jacqueline de; Silva-Barcellos, Neila M; Bellavinha, Karime R; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Groot, D W; Parr, Alan; Langguth, Peter; Polli, James E; Shah, Vinod P; Tajiri, Tomokazu; Mehta, Mehul U; Dressman, Jennifer B

2017-12-01

This work presents a review of literature and experimental data relevant to the possibility of waiving pharmacokinetic bioequivalence studies in human volunteers for approval of immediate-release solid oral pharmaceutical forms containing folic acid as the single active pharmaceutical ingredient. For dosage forms containing 5 mg folic acid, the highest dose strength on the World Health Organization Essential Medicines List, the dose/solubility ratio calculated from solubility studies was higher than 250 mL, corresponding to a classification as "not highly soluble." Small, physiological doses of folic acid (≤320 μg) seem to be absorbed completely via active transport, but permeability data for higher doses of 1-5 mg are inconclusive. Following a conservative approach, folic acid is classified as a Biopharmaceutics Classification System class IV compound until more reliable data become available. Commensurate with its solubility characteristics, the results of dissolution studies indicated that none of the folic acid products evaluated showed rapid dissolution in media at pH 1.2 or 4.5. Therefore, according to the current criteria of the Biopharmaceutics Classification System, the biowaiver approval procedure cannot be recommended for immediate-release solid oral dosage forms containing folic acid. Copyright © 2017 American Pharmacists Association®. All rights reserved.

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

Lenke and King classification systems for adolescent idiopathic scoliosis: interobserver agreement and postoperative results.

Science.gov (United States)

Hosseinpour-Feizi, Hojjat; Soleimanpour, Jafar; Sales, Jafar Ganjpour; Arzroumchilar, Ali

2011-01-01

The aim of this study was to investigate the interobserver agreement of the Lenke and King classifications for adolescent idiopathic scoliosis, and to compare the results of surgery performed based on classification of the scoliosis according to each of these classification systems. The study was conducted in Shohada Hospital in Tabriz, Iran, between 2009 and 2010. First, a reliability assessment was undertaken to assess interobserver agreement of the Lenke and King classifications for adolescent idiopathic scoliosis. Second, postoperative efficacy and safety of surgery performed based on the Lenke and King classifications were compared. Kappa coefficients of agreement were calculated to assess the agreement. Outcomes were compared using bivariate tests and repeated measures analysis of variance. A low to moderate interobserver agreement was observed for the King classification; the Lenke classification yielded mostly high agreement coefficients. The outcome of surgery was not found to be substantially different between the two systems. Based on the results, the Lenke classification method seems advantageous. This takes into consideration the Lenke classification's priority in providing details of curvatures in different anatomical surfaces to explain precise intensity of scoliosis, that it has higher interobserver agreement scores, and also that it leads to noninferior postoperative results compared with the King classification method.

Computational fluid dynamics (CFD) insights into agitation stress methods in biopharmaceutical development.

Science.gov (United States)

Bai, Ge; Bee, Jared S; Biddlecombe, James G; Chen, Quanmin; Leach, W Thomas

2012-02-28

Agitation of small amounts of liquid is performed routinely in biopharmaceutical process, formulation, and packaging development. Protein degradation commonly results from agitation, but the specific stress responsible or degradation mechanism is usually not well understood. Characterization of the agitation stress methods is critical to identifying protein degradation mechanisms or specific sensitivities. In this study, computational fluid dynamics (CFD) was used to model agitation of 1 mL of fluid by four types of common laboratory agitation instruments, including a rotator, orbital shaker, magnetic stirrer and vortex mixer. Fluid stresses in the bulk liquid and near interfaces were identified, quantified and compared. The vortex mixer provides the most intense stresses overall, while the stir bar system presented locally intense shear proximal to the hydrophobic stir bar surface. The rotator provides gentler fluid stresses, but the air-water interfacial area and surface stresses are relatively high given its low rotational frequency. The orbital shaker provides intermediate-level stresses but with the advantage of a large stable platform for consistent vial-to-vial homogeneity. Selection of experimental agitation methods with targeted types and intensities of stresses can facilitate better understanding of protein degradation mechanisms and predictability for "real world" applications. Copyright © 2011 Elsevier B.V. All rights reserved.

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 ...

Evaluation of the Waste Isolation Pilot Plant classification of systems, structures and components

International Nuclear Information System (INIS)

1985-07-01

A review of the classification system for systems, structures, and components at the Waste Isolation Pilot Plant (WIPP) was performed using the WIPP Safety Analysis Report (SAR) and Bechtel document D-76-D-03 as primary source documents. The regulations of the US Nuclear Regulatory Commission (NRC) covering ''Disposal of High level Radioactive Wastes in Geologic Repositories,'' 10 CFR 60, and the regulations relevant to nuclear power plant siting and construction (10 CFR 50, 51, 100) were used as standards to evaluate the WIPP design classification system, although it is recognized that the US Department of Energy (DOE) is not required to comply with these NRC regulations in the design and construction of WIPP. The DOE General Design Criteria Manual (DOE Order 6430.1) and the Safety Analysis and Review System for AL Operation document (AL 54f81.1A) were reviewed in part. This report includes a discussion of the historical basis for nuclear power plant requirements, a review of WIPP and nuclear power plant classification bases, and a comparison of the codes and standards applicable to each quality level. Observations made during the review of the WIPP SAR are noted in the text of this reoport. The conclusions reached by this review are: WIPP classification methodology is comparable to corresponding nuclear power procedures. The classification levels assigned to WIPP systems are qualitatively the same as those assigned to nuclear power plant systems

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

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

Quantification of biopharmaceuticals and biomarkers in complex biological matrices: a comparison of liquid chromatography coupled to tandem mass spectrometry and ligand binding assays

NARCIS (Netherlands)

Bults, Peter; van de Merbel, Nico C; Bischoff, Rainer

2015-01-01

The quantification of proteins (biopharmaceuticals or biomarkers) in complex biological samples such as blood plasma requires exquisite sensitivity and selectivity, as all biological matrices contain myriads of proteins that are all made of the same 20 proteinogenic amino acids, notwithstanding

Classification of Magnetic Nanoparticle Systems

DEFF Research Database (Denmark)

Bogren, Sara; Fornara, Andrea; Ludwig, Frank

2015-01-01

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.......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...

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

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.

On-line coupling of size exclusion chromatography with mixed-mode liquid chromatography for comprehensive profiling of biopharmaceutical drug product.

Science.gov (United States)

He, Yan; Friese, Olga V; Schlittler, Michele R; Wang, Qian; Yang, Xun; Bass, Laura A; Jones, Michael T

2012-11-02

A methodology based on on-line coupling of size exclusion chromatography (SEC) with mixed-mode liquid chromatography (LC) has been developed. The method allows for simultaneous measurement of a wide range of components in biopharmaceutical drug products. These components include the active pharmaceutical ingredient (protein) and various kinds of excipients such as cations, anions, nonionic hydrophobic surfactant and hydrophilic sugars. Dual short SEC columns are used to separate small molecule excipients from large protein molecules. The separated protein is quantified using a UV detector at 280 nm. The isolated excipients are switched, online, to the Trinity P1 mixed-mode column for separation, and detected by an evaporative light scattering detector (ELSD). Using a stationary phase with 1.7 μm particles in SEC allows for the use of volatile buffers for both SEC and mix-mode separation. This facilitates the detection of different excipients by ELSD and provides potential for online characterization of the protein with mass spectrometry (MS). The method has been applied to quantitate protein and excipients in different biopharmaceutical drug products including monoclonal antibodies (mAb), antibody drug conjugates (ADC) and vaccines. Copyright © 2012 Elsevier B.V. All rights reserved.

Arrhythmia Classification Based on Multi-Domain Feature Extraction for an ECG Recognition System

Directory of Open Access Journals (Sweden)

Hongqiang Li

2016-10-01

Full Text Available 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.

The development of Version 2 of the AN-SNAP casemix classification system.

Science.gov (United States)

Green, Janette; Gordon, Robert

2007-04-01

This paper presents the results of a recent review of the Australian National Sub-acute and Non-acute Patient (AN-SNAP) classification system. The AN-SNAP system was developed by the Centre for Health Service Development, University of Wollongong in 1997. The review was conducted between August 2005 and September 2006. Four clinical sub-committees comprising more than 50 clinicians from sub-acute services across New South Wales as well as representatives from Queensland and the Australian Capital Territory were established to develop a set of proposals to be considered for incorporation into Version 2 of the classification. It is proposed that the final AN-SNAP Version 2 classification will be available for implementation from 1 July 2007.

Endotoxin inactivation via steam-heat treatment in dilute simethicone emulsions used in biopharmaceutical processes.

Science.gov (United States)

Britt, Keith A; Galvin, Jeffrey; Gammell, Patrick; Nti-Gyabaah, Joseph; Boras, George; Kolwyck, David; Ramirez, José G; Presente, Esther; Naugle, Gregory

2014-01-01

Simethicone emulsion is used to regulate foaming in cell culture operations in biopharmaceutical processes. It is also a potential source of endotoxin contamination. The inactivation of endotoxins in dilute simethicone emulsions was assessed as a function of time at different steam temperatures using a Limulus amebocyte lysate kinetic chromogenic technique. Endotoxin inactivation from steam-heat treatment was fit to a four-parameter double exponential decay model, which indicated that endotoxin inactivation was biphasic, consisting of fast and slow regimes. In the fast regime, temperature-related effects were dominant. Transitioning into the slow regime, the observed temperature dependence diminished, and concentration-related effects became increasingly significant. The change in the Gibbs free energy moving through the transition state indicated that a large energy barrier must be overcome for endotoxin inactivation to occur. The corresponding Arrhenius pre-exponential factor was >10(12) s(-1) suggesting that endotoxins in aqueous solution exist as aggregates. The disorder associated with the endotoxin inactivation reaction pathway was assessed via the change in entropy moving through the transition state. This quantity was positive indicating that endotoxin inactivation may result from hydrolysis of individual endotoxin molecules, which perturbs the conformation of endotoxin aggregates, thereby modulating the biological activity observed. Steam-heat treatment decreased endotoxin levels by 1-2 logarithm (log) reduction (LRV), which may be practically relevant depending on incoming raw material endotoxin levels. Antifoam efficiency and cell culture performance were negligibly impacted following steam-heat treatment. The results from this study show that steam-heat treatment is a viable endotoxin control strategy that can be implemented to support large-scale biopharmaceutical manufacturing. © 2014 American Institute of Chemical Engineers.

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

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.

Classification of Flotation Frothers

Directory of Open Access Journals (Sweden)

Jan Drzymala

2018-02-01

Full Text Available In this paper, a scheme of flotation frothers classification is presented. The scheme first indicates the physical system in which a frother is present and four of them i.e., pure state, aqueous solution, aqueous solution/gas system and aqueous solution/gas/solid system are distinguished. As a result, there are numerous classifications of flotation frothers. The classifications can be organized into a scheme described in detail in this paper. The frother can be present in one of four physical systems, that is pure state, aqueous solution, aqueous solution/gas and aqueous solution/gas/solid system. It results from the paper that a meaningful classification of frothers relies on choosing the physical system and next feature, trend, parameter or parameters according to which the classification is performed. The proposed classification can play a useful role in characterizing and evaluation of flotation frothers.

Small-scale classification schemes

DEFF Research Database (Denmark)

Hertzum, Morten

2004-01-01

Small-scale classification schemes are used extensively in the coordination of cooperative work. This study investigates the creation and use of a classification scheme for handling the system requirements during the redevelopment of a nation-wide information system. This requirements...... classification inherited a lot of its structure from the existing system and rendered requirements that transcended the framework laid out by the existing system almost invisible. As a result, the requirements classification became a defining element of the requirements-engineering process, though its main...... effects remained largely implicit. The requirements classification contributed to constraining the requirements-engineering process by supporting the software engineers in maintaining some level of control over the process. This way, the requirements classification provided the software engineers...

DOE LLW classification rationale

International Nuclear Information System (INIS)

Flores, A.Y.

1991-01-01

This report was about the rationale which the US Department of Energy had with low-level radioactive waste (LLW) classification. It is based on the Nuclear Regulatory Commission's classification system. DOE site operators met to review the qualifications and characteristics of the classification systems. They evaluated performance objectives, developed waste classification tables, and compiled dose limits on the waste. A goal of the LLW classification system was to allow each disposal site the freedom to develop limits to radionuclide inventories and concentrations according to its own site-specific characteristics. This goal was achieved with the adoption of a performance objectives system based on a performance assessment, with site-specific environmental conditions and engineered disposal systems

Classification system for oral submucous fibrosis

Directory of Open Access Journals (Sweden)

Chandramani Bhagvan More

2012-01-01

Full Text Available Oral submucous fibrosis (OSMF is a potentially malignant disorder (PMD and crippling condition of oral mucosa. It is a chronic insidious scarring disease of oral cavity, pharynx and upper digestive tract, characterized by progressive inability to open the mouth due to loss of elasticity and development of vertical fibrous bands in labial and buccal tissues. OSMF is a debilitating but preventable oral disease. It predominantly affects people of Southeast Asia and Indian subcontinent, where chewing of arecanut and its commercial preparation is high. Presence of fibrous bands is the main characteristic feature of OSMF. The present literature review provides the compilation of various classification system based on clinical and/or histopathological features of OSMF from several databases. The advantages and drawbacks of these classifications supersede each other, leading to perplexity. An attempt is made to provide and update the knowledge about this potentially malignant disorder to health care providers in order to help in early detection and treatment, thus reducing the mortality of oral cancer.

Reliability of a treatment-based classification system for subgrouping people with low back pain.

Science.gov (United States)

Henry, Sharon M; Fritz, Julie M; Trombley, Andrea R; Bunn, Janice Y

2012-09-01

Observational, cross-sectional reliability study. To examine the interrater reliability of novice raters in their use of the treatment-based classification (TBC) system for low back pain and to explore the patterns of disagreement in classification errors. Although the interrater reliability of individual test items in the TBC system is moderate to good, some error persists in classification decision making. Understanding which classification errors are common could direct further refinement of the TBC system. Using previously recorded patient data (n = 24), 12 novice raters classified patients according to the TBC schema. These classification results were combined with those of 7 other raters, allowing examination of the overall agreement using the kappa statistic, as well as agreement/disagreement among pairwise comparisons in classification assignments. A chi-square test examined differences in percent agreement between the novice and more experienced raters and differences in classification distributions between these 2 groups of raters. Among 12 novice raters, there was 80.9% agreement in the pairs of classification (κ = 0.62; 95% confidence interval: 0.59, 0.65) and an overall 75.5% agreement (κ = 0.57; 95% confidence interval: 0.55, 0.69) for the combined data set. Raters were least likely to agree on a classification of stabilization (77.5% agreement). The overall percentage of pairwise classification judgments that disagreed was 24.5%, with the most common disagreement being between manipulation and stabilization (11.0%), followed by a mismatch between stabilization and specific exercise (8.2%). Additional refinement is needed to reduce rater disagreement that persists in the TBC decision-making algorithm, particularly in the stabilization category. J Orthop Sports Phys Ther 2012;42(9):797-805, Epub 7 June 2012. doi:10.2519/jospt.2012.4078.

Novel classification system of rib fractures observed in infants.

Science.gov (United States)

Love, Jennifer C; Derrick, Sharon M; Wiersema, Jason M; Pinto, Deborrah C; Greeley, Christopher; Donaruma-Kwoh, Marcella; Bista, Bibek

2013-03-01

Rib fractures are considered highly suspicious for nonaccidental injury in the pediatric clinical literature; however, a rib fracture classification system has not been developed. As an aid and impetus for rib fracture research, we developed a concise schema for classifying rib fracture types and fracture location that is applicable to infants. The system defined four fracture types (sternal end, buckle, transverse, and oblique) and four regions of the rib (posterior, posterolateral, anterolateral, and anterior). It was applied to all rib fractures observed during 85 consecutive infant autopsies. Rib fractures were found in 24 (28%) of the cases. A total of 158 rib fractures were identified. The proposed schema was adequate to classify 153 (97%) of the observed fractures. The results indicate that the classification system is sufficiently robust to classify rib fractures typically observed in infants and should be used by researchers investigating infant rib fractures. © 2013 American Academy of Forensic Sciences.

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 ...

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

African Journals Online (AJOL)

Mapiye, C, Dr

2017-05-15

May 15, 2017 ... beef carcass grading and classification systems used in the region ..... between cattle breeds (genetic), pre-slaughter stress and growth- ..... Nguni cattle for example, owing to their adaptability (i.e. drought and heat tolerant,.

Classification of Maize in Complex Smallholder Farming Systems Using UAV Imagery

Directory of Open Access Journals (Sweden)

Ola Hall

2018-06-01

Full Text Available Yield estimates and yield gap analysis are important for identifying poor agricultural productivity. Remote sensing holds great promise for measuring yield and thus determining yield gaps. Farming systems in sub-Saharan Africa (SSA are commonly characterized by small field size, intercropping, different crop species with similar phenologies, and sometimes high cloud frequency during the growing season, all of which pose real challenges to remote sensing. Here, an unmanned aerial vehicle (UAV system based on a quadcopter equipped with two consumer-grade cameras was used for the delineation and classification of maize plants on smallholder farms in Ghana. Object-oriented image classification methods were applied to the imagery, combined with measures of image texture and intensity, hue, and saturation (IHS, in order to achieve delineation. It was found that the inclusion of a near-infrared (NIR channel and red–green–blue (RGB spectra, in combination with texture or IHS, increased the classification accuracy for both single and mosaic images to above 94%. Thus, the system proved suitable for delineating and classifying maize using RGB and NIR imagery and calculating the vegetation fraction, an important parameter in producing yield estimates for heterogeneous smallholder farming systems.

Intelligent Decision Support System for Bank Loans Risk Classification

Institute of Scientific and Technical Information of China (English)

杨保安; 马云飞; 俞莲

2001-01-01

Intelligent Decision Support System (IISS) for Bank Loans Risk Classification (BLRC), based on the way of integration Artificial Neural Network (ANN) and Expert System (ES), is proposed. According to the feature of BLRC, the key financial and non-financial factors are analyzed. Meanwhile, ES and Model Base (MB) which contain ANN are designed . The general framework,interaction and integration of the system are given. In addition, how the system realizes BLRC is elucidated in detail.

Lenke and King classification systems for adolescent idiopathic scoliosis: interobserver agreement and postoperative results

Directory of Open Access Journals (Sweden)

Hosseinpour-Feizi H

2011-12-01

Full Text Available Hojjat Hosseinpour-Feizi, Jafar Soleimanpour, Jafar Ganjpour Sales, Ali ArzroumchilarDepartment of Orthopedics, Shohada Hospital, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, IranPurpose: The aim of this study was to investigate the interobserver agreement of the Lenke and King classifications for adolescent idiopathic scoliosis, and to compare the results of surgery performed based on classification of the scoliosis according to each of these classification systems.Methods: The study was conducted in Shohada Hospital in Tabriz, Iran, between 2009 and 2010. First, a reliability assessment was undertaken to assess interobserver agreement of the Lenke and King classifications for adolescent idiopathic scoliosis. Second, postoperative efficacy and safety of surgery performed based on the Lenke and King classifications were compared. Kappa coefficients of agreement were calculated to assess the agreement. Outcomes were compared using bivariate tests and repeated measures analysis of variance.Results: A low to moderate interobserver agreement was observed for the King classification; the Lenke classification yielded mostly high agreement coefficients. The outcome of surgery was not found to be substantially different between the two systems.Conclusion: Based on the results, the Lenke classification method seems advantageous. This takes into consideration the Lenke classification’s priority in providing details of curvatures in different anatomical surfaces to explain precise intensity of scoliosis, that it has higher interobserver agreement scores, and also that it leads to noninferior postoperative results compared with the King classification method.Keywords: test reliability, scoliosis classification, postoperative efficacy, adolescents

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)

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.

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)

Classification of $E_{0}$-semigroups by product systems

CERN Document Server

Skeide, Michael

2016-01-01

In these notes the author presents a complete theory of classification of E_0-semigroups by product systems of correspondences. As an application of his theory, he answers the fundamental question if a Markov semigroup admits a dilation by a cocycle perturbations of noise: It does if and only if it is spatial.

Guidance on classification for reproductive toxicity under the globally harmonized system of classification and labelling of chemicals (GHS).

Science.gov (United States)

Moore, Nigel P; Boogaard, Peter J; Bremer, Susanne; Buesen, Roland; Edwards, James; Fraysse, Benoit; Hallmark, Nina; Hemming, Helena; Langrand-Lerche, Carole; McKee, Richard H; Meisters, Marie-Louise; Parsons, Paul; Politano, Valerie; Reader, Stuart; Ridgway, Peter; Hennes, Christa

2013-11-01

The Globally Harmonised System of Classification (GHS) is a framework within which the intrinsic hazards of substances may be determined and communicated. It is not a legislative instrument per se, but is enacted into national legislation with the appropriate legislative instruments. GHS covers many aspects of effects upon health and the environment, including adverse effects upon sexual function and fertility or on development. Classification for these effects is based upon observations in humans or from properly designed experiments in animals, although only the latter is covered herein. The decision to classify a substance based upon experimental data, and the category of classification ascribed, is determined by the level of evidence that is available for an adverse effect on sexual function and fertility or on development that does not arise as a secondary non-specific consequence of other toxic effect. This document offers guidance on the determination of level of concern as a measure of adversity, and the level of evidence to ascribe classification based on data from tests in laboratory animals.

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

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)

CLASSIFICATION OF THE MGR MAINTENANCE AND SUPPLY 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) maintenance and supply 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)

A new web-based system for unsupervised classification of satellite images from the Google Maps engine

Science.gov (United States)

Ferrán, Ángel; Bernabé, Sergio; García-Rodríguez, Pablo; Plaza, Antonio

2012-10-01

In this paper, we develop a new web-based system for unsupervised classification of satellite images available from the Google Maps engine. The system has been developed using the Google Maps API and incorporates functionalities such as unsupervised classification of image portions selected by the user (at the desired zoom level). For this purpose, we use a processing chain made up of the well-known ISODATA and k-means algorithms, followed by spatial post-processing based on majority voting. The system is currently hosted on a high performance server which performs the execution of classification algorithms and returns the obtained classification results in a very efficient way. The previous functionalities are necessary to use efficient techniques for the classification of images and the incorporation of content-based image retrieval (CBIR). Several experimental validation types of the classification results with the proposed system are performed by comparing the classification accuracy of the proposed chain by means of techniques available in the well-known Environment for Visualizing Images (ENVI) software package. The server has access to a cluster of commodity graphics processing units (GPUs), hence in future work we plan to perform the processing in parallel by taking advantage of the cluster.

Relevance of the formal red meat classification system to the South ...

African Journals Online (AJOL)

Relevance of the formal red meat classification system to the South African ... to market information make them less willing to sell their animals through the formal market. ... Keywords: Communal farmers, marketing system, meat industry ...

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.)

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

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.

Impact of Postapproval Evidence Generation on the Biopharmaceutical Industry.

Science.gov (United States)

Milne, Christopher-Paul; Cohen, Joshua P; Felix, Abigail; Chakravarthy, Ranjana

2015-08-01

Meeting marketplace demands for proving the value of new products requires more data than the industry has routinely produced. These data include evidence from comparative effectiveness research (CER), including randomized, controlled trials; pragmatic clinical trials; observational studies; and meta-analyses. We designed and conducted a survey to examine the industry's perceptions on new data requirements regarding CER evidence, the acceptability of postapproval study types, payer-specific issues related to CER, communication of data being generated postapproval, and methods used for facilitating postapproval evidence generation. CER is being used by payers for most types of postapproval decisions. Randomized, controlled trials were indicated as the most acceptable form of evidence. At the same time, there was support for the utility of other types of studies, such as pragmatic clinical trials and observational studies. Respondents indicated the use of multiple formats for communicating postapproval data with many different stakeholders including regulators, payers, providers, and patients. Risk-sharing agreements with payers were unanimously supported by respondents with regard to certain products with unclear clinical and economic outcomes at launch. In these instances, conditional reimbursement through coverage with evidence development was considered a constructive option. The Food and Drug Administration's initiative called Regulatory Science was considered by the respondents as having the most impact on streamlining the generation of postapproval research-related evidence. The biopharmaceutical industry is faced with a broad and complex set of challenges related to evidence generation for postapproval decisions by a variety of health care system stakeholders. Uncertainty remains as to how the industry and payers use postapproval studies to guide decision making with regard to pricing and reimbursement status. Correspondingly, there is uncertainty regarding

A systematic review of definitions and classification systems of adjacent segment pathology.

Science.gov (United States)

Kraemer, Paul; Fehlings, Michael G; Hashimoto, Robin; Lee, Michael J; Anderson, Paul A; Chapman, Jens R; Raich, Annie; Norvell, Daniel C

2012-10-15

Systematic review. To undertake a systematic review to determine how "adjacent segment degeneration," "adjacent segment disease," or clinical pathological processes that serve as surrogates for adjacent segment pathology are classified and defined in the peer-reviewed literature. Adjacent segment degeneration and adjacent segment disease are terms referring to degenerative changes known to occur after reconstructive spine surgery, most commonly at an immediately adjacent functional spinal unit. These can include disc degeneration, instability, spinal stenosis, facet degeneration, and deformity. The true incidence and clinical impact of degenerative changes at the adjacent segment is unclear because there is lack of a universally accepted classification system that rigorously addresses clinical and radiological issues. A systematic review of the English language literature was undertaken and articles were classified using the Grades of Recommendation Assessment, Development, and Evaluation criteria. RESULTS.: Seven classification systems of spinal degeneration, including degeneration at the adjacent segment, were identified. None have been evaluated for reliability or validity specific to patients with degeneration at the adjacent segment. The ways in which terms related to adjacent segment "degeneration" or "disease" are defined in the peer-reviewed literature are highly variable. On the basis of the systematic review presented in this article, no formal classification system for either cervical or thoracolumbar adjacent segment disorders currently exists. No recommendations regarding the use of current classification of degeneration at any segments can be made based on the available literature. A new comprehensive definition for adjacent segment pathology (ASP, the now preferred terminology) has been proposed in this Focus Issue, which reflects the diverse pathology observed at functional spinal units adjacent to previous spinal reconstruction and balances

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.

Extending an emergency classification expert system to the real-time environment

International Nuclear Information System (INIS)

Greene, K.R.; Robinson, A.H.

1990-01-01

The process of determining emergency action level (EAL) during real or simulated emergencies at the Trojan nuclear power plant was automated in 1988 with development of the EM-CLASS expert system. This system serves to replace the manual flip-chart method of determining the EAL. While the task of performing the classification is more reliable when using EM-CLASS, it still takes as long to determine the appropriate EAL with EM-CLASS as it does with the flowchart tracing method currently in use. During a plant emergency, an environment will exist where there are not enough resources to complete all of the desired tasks. To change this condition, some tasks must be accomplished with greater efficiency. The EM-CLASS application may be improved by taking advantage of the fact that most of the responses to the questions in the emergency classification procedure, EP-001, are available directly from plant measurements. This information could be passed to the expert system electronically. A prototype demonstration of a real-time emergency classification expert system has been developed. It repetitively performs the consultation, acquiring the necessary data electronically when possible and from the user when electronic data are unavailable. The expert system is being tested with scenarios from the drills and graded exercises that have taken place at the Trojan nuclear power plant. The goal of this project is to install the system on the plant simulator and/or the plant computer

Classification of building systems for concrete 3D printing

OpenAIRE

DUBALLET , Romain; BAVEREL , Olivier; Dirrenberger , Justin

2017-01-01

In the present paper, a study is conducted on building systems associated with concrete extrusion-based additive manufacturing techniques. Specific parameters are highlighted - concerning scale, environment, support, and assembly strategies - and a classification method is introduced. The objective is to explicitly characterise construction systems based on such printing processes. A cartography of the different approaches and subsequent robotic complexity is proposed. The state of the art ga...

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…

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.

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.

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.

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

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

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

African Journals Online (AJOL)

2015-10-05

Oct 5, 2015 ... 6Department of Plant Sciences, University of the Free State, Qwaqwa Campus, Private .... classification systems for wetlands and other inland aquatic ... of vegetation, soil, inundation and landform features that are ... nised as the fundamental drivers that determine the existence ...... Earth Obs. Remote Sens.

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....

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.

A probablistic neural network classification system for signal and image processing

Energy Technology Data Exchange (ETDEWEB)

Bowman, B. [Lawrence Livermore National Lab., CA (United States)

1994-11-15

The Acoustical Heart Valve Analysis Package is a system for signal and image processing and classification. It is being developed in both Matlab and C, to provide an interactive, interpreted environment, and has been optimized for large scale matrix operations. It has been used successfully to classify acoustic signals from implanted prosthetic heart valves in human patients, and will be integrated into a commercial Heart Valve Screening Center. The system uses several standard signal processing algorithms, as well as supervised learning techniques using the probabilistic neural network (PNN). Although currently used for the acoustic heart valve application, the algorithms and modular design allow it to be used for other applications, as well. We will describe the signal classification system, and show results from a set of test valves.

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

Accumulation of organic compounds leached from plastic materials used in biopharmaceutical process containers.

Science.gov (United States)

Jenke, Dennis R; Zietlow, David; Garber, Mary Jo; Sadain, Salma; Reiber, Duane; Terbush, William

2007-01-01

Plastic materials are widely used in medical items, such as solution containers, transfusion sets, transfer tubing, and devices. An emerging trend in the biotechnology industry is the utilization of plastic containers to prepare, transport, and store an assortment of solutions including buffers, media, and in-process and finished product. The direct contact of such containers with the product at one or more points in its lifetime raises the possibility that container leachables may accumulate in the finished product. The interaction between several commercially available container materials and numerous model test solutions (representative of buffers and media used in biopharmaceutical applications) was investigated. This paper summarizes the identification of leachables associated with the container materials and documents the levels to which targeted leachables accumulate in the test solutions under defined storage conditions.

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.

Stochastic change detection in uncertain nonlinear systems using reduced-order models: classification

International Nuclear Information System (INIS)

Yun, Hae-Bum; Masri, Sami F

2009-01-01

A reliable structural health monitoring methodology (SHM) is proposed to detect relatively small changes in uncertain nonlinear systems. A total of 4000 physical tests were performed using a complex nonlinear magneto-rheological (MR) damper. With the effective (or 'genuine') changes and uncertainties in the system characteristics of the semi-active MR damper, which were precisely controlled with known means and standard deviation of the input current, the tested MR damper was identified with the restoring force method (RFM), a non-parametric system identification method involving two-dimensional orthogonal polynomials. Using the identified RFM coefficients, both supervised and unsupervised pattern recognition techniques (including support vector classification and k-means clustering) were employed to detect system changes in the MR damper. The classification results showed that the identified coefficients with orthogonal basis function can be used as reliable indicators for detecting (small) changes, interpreting the physical meaning of the detected changes without a priori knowledge of the monitored system and quantifying the uncertainty bounds of the detected changes. The classification errors were analyzed using the standard detection theory to evaluate the performance of the developed SHM methodology. An optimal classifier design procedure was also proposed and evaluated to minimize type II (or 'missed') errors

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...

Inter- and intrareader variability in the interpretation of two radiographic classification systems for juvenile rheumatoid arthritis

International Nuclear Information System (INIS)

Doria, Andrea S.; Castro, Claudio C. de; Sernik, Renato A.; Vitule, Luis F.; Arantes, Paula R.; Lucato, Leandro; Germano, Marco A.N.; Cerri, Giovanni G.; Kiss, Maria Helena B.; Silva, Carlos H.M.; Zerbini, Cristiano A.F.

2003-01-01

To evaluate the inter- and intrareader variability for interpretation of a modified Larsen's radiographic classification system for juvenile rheumatoid arthritis (JRA) focused on osteochondral lesions and a conventional Larsen's classification system, compared to a reference MR scoring system of corresponding images. Seventy-five radiographs of 60 children with JRA, performed within a short interval of time from the MR examinations, were independently evaluated by three experienced radiologists, three diagnostic imaging residents and three rheumatologists, in two separate sessions, according to the two different classification methods, blinded to the corresponding MR images. The inter- and intrareader concordance rates between the two radiographic classification systems and the MR-related radiographs were respectively poor and poor/moderate. The interobserver range of weighted kappa values for the conventional and the modified Larsen's system respectively was 0.25-0.37 vs 0.19-0.39 for radiologists, 0.25-0.37 vs 0.18-0.30 for residents and 0.19-0.51 vs 0.17-0.29 for rheumatologists. The intrareader rate ranged from 0.17-0.55 for radiologists, 0.2-0.56 for residents, and 0.14-0.59 for rheumatologists. Although the proposal of a new radiographic classification system for JRA focused on osteochondral abnormalities sounds promising, the low inter- and intrareader concordance rates with an MR-related radiographic system makes the clinical applicability of such a radiographic system less suitable. (orig.)

DIAGNOSTICS OF DISORDERS AND DISEASES OF MUSCULOSKELETAL SYSTEM IN SCHOOLCHILDREN: APPROACHES, TERMINOLOGY, CLASSIFICATION

Directory of Open Access Journals (Sweden)

N.B. Mirskaya

2009-01-01

Full Text Available This article describes an information system for physicians working in general education institutes, which is named «Detection, correction and prophylaxis of musculoskeletal system disorders in students of general education institutes». This system was created for the purpose of improving diagnostics of initial stages of musculoskeletal system in schoolchildren, detecting of risk factors, and for the provision of timely prophylaxis during school education. The system was based on classification of functional disorders and initial stages of diseases of musculoskeletal system in schoolchildren, developed by authors of present article, and methods of medical examination and organization of this work.Key words: schoolchildren, musculoskeletal system, diagnostics, classification, prophylaxis.(Voprosy sovremennoi pediatrii — Current Pediatrics. 2009;8(3:10-13

Improved wavelet packet classification algorithm for vibrational intrusions in distributed fiber-optic monitoring systems

Science.gov (United States)

Wang, Bingjie; Pi, Shaohua; Sun, Qi; Jia, Bo

2015-05-01

An improved classification algorithm that considers multiscale wavelet packet Shannon entropy is proposed. Decomposition coefficients at all levels are obtained to build the initial Shannon entropy feature vector. After subtracting the Shannon entropy map of the background signal, components of the strongest discriminating power in the initial feature vector are picked out to rebuild the Shannon entropy feature vector, which is transferred to radial basis function (RBF) neural network for classification. Four types of man-made vibrational intrusion signals are recorded based on a modified Sagnac interferometer. The performance of the improved classification algorithm has been evaluated by the classification experiments via RBF neural network under different diffusion coefficients. An 85% classification accuracy rate is achieved, which is higher than the other common algorithms. The classification results show that this improved classification algorithm can be used to classify vibrational intrusion signals in an automatic real-time monitoring system.

Overweight and Obesity Prevalence Among School-Aged Nunavik Inuit Children According to Three Body Mass Index Classification Systems.

Science.gov (United States)

Medehouenou, Thierry Comlan Marc; Ayotte, Pierre; St-Jean, Audray; Meziou, Salma; Roy, Cynthia; Muckle, Gina; Lucas, Michel

2015-07-01

Little is known about the suitability of three commonly used body mass index (BMI) classification system for Indigenous children. This study aims to estimate overweight and obesity prevalence among school-aged Nunavik Inuit children according to International Obesity Task Force (IOTF), Centers for Disease Control and Prevention (CDC), and World Health Organization (WHO) BMI classification systems, to measure agreement between those classification systems, and to investigate whether BMI status as defined by these classification systems is associated with levels of metabolic and inflammatory biomarkers. Data were collected on 290 school-aged children (aged 8-14 years; 50.7% girls) from the Nunavik Child Development Study with data collected in 2005-2010. Anthropometric parameters were measured and blood sampled. Participants were classified as normal weight, overweight, and obese according to BMI classification systems. Weighted kappa (κw) statistics assessed agreement between different BMI classification systems, and multivariate analysis of variance ascertained their relationship with metabolic and inflammatory biomarkers. The combined prevalence rate of overweight/obesity was 26.9% (with 6.6% obesity) with IOTF, 24.1% (11.0%) with CDC, and 40.4% (12.8%) with WHO classification systems. Agreement was the highest between IOTF and CDC (κw = .87) classifications, and substantial for IOTF and WHO (κw = .69) and for CDC and WHO (κw = .73). Insulin and high-sensitivity C-reactive protein plasma levels were significantly higher from normal weight to obesity, regardless of classification system. Among obese subjects, higher insulin level was observed with IOTF. Compared with other systems, IOTF classification appears to be more specific to identify overweight and obesity in Inuit children. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

The revised WHO dengue case classification: does the system need to be modified?

Science.gov (United States)

Hadinegoro, Sri Rezeki S

2012-05-01

There has been considerable debate regarding the value of both the 1997 and 2009 World Health Organization (WHO) dengue case classification criteria for its diagnosis and management. Differentiation between classic dengue fever (DF) and dengue haemorrhagic fever (DHF) or severe dengue is a key aspect of dengue case classification. The geographic expansion of dengue and its increased incidence in older age groups have contributed to the limited applicability of the 1997 case definitions. Clinical experience of dengue suggests that the illness presents as a spectrum of disease instead of distinct phases. However, despite the rigid grouping of dengue into DF, DHF and dengue shock syndrome (DSS), overlap between the different manifestations has often been observed, which has affected clinical management and triage of patients. The findings of the DENCO study evaluating the 1997 case definitions formed the basis of the revised 2009 WHO case definitions, which classified the illness into dengue with and without warning signs and severe dengue. Although the revised scheme is more sensitive to the diagnosis of severe dengue, and beneficial to triage and case management, there remain issues with its applicability. It is considered by many to be too broad, requiring more specific definition of warning signs. Quantitative research into the predictive value of these warning signs on patient outcomes and the cost-effectiveness of the new classification system is required to ascertain whether the new classification system requires further modification, or whether elements of both classification systems can be combined.

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.

The development of the globally harmonized system (GHS) of classification and labelling of hazardous chemicals

International Nuclear Information System (INIS)

Winder, Chris; Azzi, Rola; Wagner, Drew

2005-01-01

The hazards of chemicals can be classified using classification criteria that are based on physical, chemical and ecotoxicological endpoints. These criteria may be developed be iteratively, based on scientific or regulatory processes. A number of national and international schemes have been developed over the past 50 years, and some, such as the UN Dangerous Goods system or the EC system for hazardous substances, are in widespread use. However, the unnecessarily complicated multiplicity of existing hazard classifications created much unnecessary confusion at the user level, and a recommendation was made at the 1992 Rio Earth summit to develop a globally harmonized chemical hazard classification and compatible labelling system, including material safety data sheets and easily understandable symbols, that could be used for manufacture, transport, use and disposal of chemical substances. This became the globally harmonized system for the Classification and Labelling of Chemicals (GHS). The developmental phase of the GHS is largely complete. Consistent criteria for categorising chemicals according to their toxic, physical, chemical and ecological hazards are now available. Consistent hazard communication tools such as labelling and material safety data sheets are also close to finalisation. The next phase is implementation of the GHS. The Intergovernmental Forum for Chemical Safety recommends that all countries implement the GHS as soon as possible with a view to have the system fully operational by 2008. When the GHS is in place, the world will finally have one system for classification of chemical hazards

Prognostic value of computed tomography classification systems for intra-articular calcaneus fractures.

Science.gov (United States)

Swords, Michael P; Alton, Timothy B; Holt, Sarah; Sangeorzan, Bruce J; Shank, John R; Benirschke, Stephen K

2014-10-01

There are several published computed tomography (CT) classification systems for calcaneus fractures, each validated by a different standard. The goal of this study was to measure which system would best predict clinical outcomes as measured by a widely used and validated musculoskeletal health status questionnaire. Forty-nine patients with isolated intra-articular joint depression calcaneus fractures more than 2 years after treatment were identified. All had preoperative CT studies and were treated with open reduction and plate fixation using a lateral extensile approach. Four different blinded reviewers classified injuries according to the CT classification systems of Crosby and Fitzgibbons, Eastwood, and Sanders. Functional outcomes evaluated with a Musculoskeletal Functional Assessment (MFA). The mean follow-up was 4.3 years. The mean MFA score was 15.7 (SD = 11.6), which is not significantly different from published values for midfoot injuries, hindfoot injuries, or both, 1 year after injury (mean = 22.1, SD = 18.4). The classification systems of Crosby and Fitzgibbons, Eastwood, and Sanders, the number of fragments of the posterior facet, and payer status were not significantly associated with outcome as determined by the MFA. The Sanders classification trended toward significance. Anterior process comminution and surgeon's overall impression of severity were significantly associated with functional outcome. The amount of anterior process comminution was an important determinant of functional outcome with increasing anterior process comminution significantly associated with worsened functional outcome (P = .04). In addition, the surgeon's overall impression of severity of injury was predictive of functional outcome (P = .02), as determined by MFA. Level III, comparative series. © The Author(s) 2014.

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)...

Reliability testing of two classification systems for osteoarthritis and post-traumatic arthritis of the elbow.

Science.gov (United States)

Amini, Michael H; Sykes, Joshua B; Olson, Stephen T; Smith, Richard A; Mauck, Benjamin M; Azar, Frederick M; Throckmorton, Thomas W

2015-03-01

The severity of elbow arthritis is one of many factors that surgeons must evaluate when considering treatment options for a given patient. Elbow surgeons have historically used the Broberg and Morrey (BM) and Hastings and Rettig (HR) classification systems to radiographically stage the severity of post-traumatic arthritis (PTA) and primary osteoarthritis (OA). We proposed to compare the intraobserver and interobserver reliability between systems for patients with either PTA or OA. The radiographs of 45 patients were evaluated at least 2 weeks apart by 6 evaluators of different levels of training. Intraobserver and interobserver reliability were calculated by Spearman correlation coefficients with 95% confidence intervals. Agreement was considered almost perfect for coefficients >0.80 and substantial for coefficients of 0.61 to 0.80. In patients with both PTA and OA, intraobserver reliability and interobserver reliability were substantial, with no difference between classification systems. There were no significant differences in intraobserver or interobserver reliability between attending physicians and trainees for either classification system (all P > .10). The presence of fracture implants did not affect reliability in the BM system but did substantially worsen reliability in the HR system (intraobserver P = .04 and interobserver P = .001). The BM and HR classifications both showed substantial intraobserver and interobserver reliability for PTA and OA. Training level differences did not affect reliability for either system. Both trainees and fellowship-trained surgeons may easily and reliably apply each classification system to the evaluation of primary elbow OA and PTA, although the HR system was less reliable in the presence of fracture implants. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

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.

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

African Journals Online (AJOL)

Soji, Zimkhitha

2017-07-24

Jul 24, 2017 ... standards used in the current South African classification system do not ..... South African beef is trimmed of visible fat, it compares favourably in terms of lipid ... structures, insufficient research on goat meat and technological ...

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 ...

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

African Journals Online (AJOL)

This paper reviewed the clinicopathologic presentation of recurrent ameloblastoma in 30 Nigerian patients at three tertiary referral centers with the sole objective of developing a classification system. Most recurrences occurred in patients in their 3rd decade of life (20-29years) and males were more frequently affected than ...

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 reliable for classifying different stages of OCD of the humeral capitellum. However, it is unclear whether radiographic evidence of OCD of the humeral capitellum, as categorized by the Minami Classification, guides 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.

Library Classification 2020

Science.gov (United States)

Harris, Christopher

2013-01-01

In this article the author explores how a new library classification system might be designed using some aspects of the Dewey Decimal Classification (DDC) and ideas from other systems to create something that works for school libraries in the year 2020. By examining what works well with the Dewey Decimal System, what features should be carried…

[GRADE system: classification of quality of evidence and strength of recommendation].

Science.gov (United States)

Aguayo-Albasini, José Luis; Flores-Pastor, Benito; Soria-Aledo, Víctor

2014-02-01

The acquisition and classification of scientific evidence, and subsequent formulation of recommendations constitute the basis for the development of clinical practice guidelines. There are several systems for the classification of evidence and strength of recommendations; the most commonly used nowadays is the Grading of Recommendations, Assessment, Development and Evaluation system (GRADE). The GRADE system initially classifies the evidence into high or low, coming from experimental or observational studies; subsequently and following a series of considerations, the evidence is classified into high, moderate, low or very low. The strength of recommendations is based not only on the quality of the evidence, but also on a series of factors such as the risk/benefit balance, values and preferences of the patients and professionals, and the use of resources or costs. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

[Diversity and classification system of weed community in Harbin City, China].

Science.gov (United States)

Chen, Xiao-Shuang; Liang, Hong; Song, Kun; Da, Liang-Jun

2014-08-01

To analyze the causes of weed community diversity and their strategies of adaption to the high heterogeneity of urban habitats, weed communities in the central urban area of Harbin, China were studied, and a classification system was established for the weed communities. There were 175 weed species, belonging to 128 genera and 38 families. The heterogeneous urban habitats and species' temporal niche differentiation resulted in the highly diversified weed communities. The high proportions of mono-species dominance and annual species dominance communities were their response to the unstable urban habitats under human disturbances with high intensities and frequencies. A four-level classification system was established in terms of plant species and habitat conditions. Within this system, the identified 1763 weed communities could be categorized into two types of life form, 5 types of dormancy form, 22 community groups, and 119 dominance communities.

Initial steps towards an evidence-based classification system for golfers with a physical impairment

NARCIS (Netherlands)

Stoter, Inge K.; Hettinga, Florentina J.; Altmann, Viola; Eisma, Wim; Arendzen, Hans; Bennett, Tony; van der Woude, Lucas H.; Dekker, Rienk

2017-01-01

Purpose: The present narrative review aims to make a first step towards an evidence-based classification system in handigolf following the International Paralympic Committee (IPC). It intends to create a conceptual framework of classification for handigolf and an agenda for future research. Method:

Classification of transportation packaging and dry spent fuel storage system components according to importance to safety

International Nuclear Information System (INIS)

McConnell, J.W., Jr; Ayers, A.L. Jr; Tyacke, M.J.

1996-02-01

This report provides a graded approach for classification of components used in transportation packaging 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 were identified. Discussions were held with suppliers and fabricators of packagings and storage systems to determine current practices. The methodology used in this report is based on Regulatory Guide 7.10, Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material. This report also includes a list of generic components for each of the general types of transportation packagings and spent fuel storage systems. The safety importance of each component is discussed, and a classification category is assigned

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

A Preliminary Study on the Multiple Mapping Structure of Classification Systems for Heterogeneous Databases

OpenAIRE

Seok-Hyoung Lee; Hwan-Min Kim; Ho-Seop Choe

2012-01-01

While science and technology information service portals and heterogeneous databases produced in Korea and other countries are integrated, methods of connecting the unique classification systems applied to each database have been studied. Results of technologists' research, such as, journal articles, patent specifications, and research reports, are organically related to each other. In this case, if the most basic and meaningful classification systems are not connected, it is difficult to ach...

Study on the Safety Classification Criteria of Mechanical Systems and Components for Open Pool-Type Research Reactors

International Nuclear Information System (INIS)

Belal, Al Momani; Jo, Jong Chull

2013-01-01

This paper describes a new compromised safety classification approach based on the comparative study of the different practices in safety classification of mechanical systems and components of open pool-type RRs, which have been adopted by several developed countries in the nuclear power area. It is hoped that the proposed safety classification criteria will be used to develop a harmonized consensus international standard. Different safety classification criteria for systems, structures, and components (SSCs) of nuclear reactors are used among the countries that export or import nuclear reactor technology, which may make the nuclear technology trade and exchange difficult. Thus, such various different approaches of safety classification need to be compromised to establish a global standard. This article proposes practicable optimized criteria for safety classification of SSCs for open pool-type research reactors (RRs)

Study on the Safety Classification Criteria of Mechanical Systems and Components for Open Pool-Type Research Reactors

Energy Technology Data Exchange (ETDEWEB)

Belal, Al Momani [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of); Jo, Jong Chull [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2013-10-15

This paper describes a new compromised safety classification approach based on the comparative study of the different practices in safety classification of mechanical systems and components of open pool-type RRs, which have been adopted by several developed countries in the nuclear power area. It is hoped that the proposed safety classification criteria will be used to develop a harmonized consensus international standard. Different safety classification criteria for systems, structures, and components (SSCs) of nuclear reactors are used among the countries that export or import nuclear reactor technology, which may make the nuclear technology trade and exchange difficult. Thus, such various different approaches of safety classification need to be compromised to establish a global standard. This article proposes practicable optimized criteria for safety classification of SSCs for open pool-type research reactors (RRs)

Classification systems for causes of stillbirth and neonatal death, 2009-2014: an assessment of alignment with characteristics for an effective global system.

Science.gov (United States)

Leisher, Susannah Hopkins; Teoh, Zheyi; Reinebrant, Hanna; Allanson, Emma; Blencowe, Hannah; Erwich, Jan Jaap; Frøen, J Frederik; Gardosi, Jason; Gordijn, Sanne; Gülmezoglu, A Metin; Heazell, Alexander E P; Korteweg, Fleurisca; Lawn, Joy; McClure, Elizabeth M; Pattinson, Robert; Smith, Gordon C S; Tunçalp, Ӧzge; Wojcieszek, Aleena M; Flenady, Vicki

2016-09-15

To reduce the burden of 5.3 million stillbirths and neonatal deaths annually, an understanding of causes of deaths is critical. A systematic review identified 81 systems for classification of causes of stillbirth (SB) and neonatal death (NND) between 2009 and 2014. The large number of systems hampers efforts to understand and prevent these deaths. This study aimed to assess the alignment of current classification systems with expert-identified characteristics for a globally effective classification system. Eighty-one classification systems were assessed for alignment with 17 characteristics previously identified through expert consensus as necessary for an effective global system. Data were extracted independently by two authors. Systems were assessed against each characteristic and weighted and unweighted scores assigned to each. Subgroup analyses were undertaken by system use, setting, type of death included and type of characteristic. None of the 81 systems were aligned with more than 9 of the 17 characteristics; most (82 %) were aligned with four or fewer. On average, systems were aligned with 19 % of characteristics. The most aligned system (Frøen 2009-Codac) still had an unweighted score of only 9/17. Alignment with individual characteristics ranged from 0 to 49 %. Alignment was somewhat higher for widely used as compared to less used systems (22 % v 17 %), systems used only in high income countries as compared to only in low and middle income countries (20 % vs 16 %), and systems including both SB and NND (23 %) as compared to NND-only (15 %) and SB-only systems (13 %). Alignment was higher with characteristics assessing structure (23 %) than function (15 %). There is an unmet need for a system exhibiting all the characteristics of a globally effective system as defined by experts in the use of systems, as none of the 81 contemporary classification systems assessed was highly aligned with these characteristics. A particular concern in terms of

The biopharmaceutics of successful controlled release drug product: Segmental-dependent permeability of glipizide vs. metoprolol throughout the intestinal tract.

Science.gov (United States)

Zur, Moran; Cohen, Noa; Agbaria, Riad; Dahan, Arik

2015-07-15

The purpose of this work was to study the challenges and prospects of regional-dependent absorption in a controlled-release scenario, through the oral biopharmaceutics of the sulfonylurea antidiabetic drug glipizide. The BCS solubility class of glipizide was determined, and its physicochemical properties and intestinal permeability were thoroughly investigated, both in-vitro (PAMPA and Caco-2) and in-vivo in rats. Metoprolol was used as the low/high permeability class boundary marker. Glipizide was found to be a low-solubility compound. All intestinal permeability experimental methods revealed similar trend; a mirror image small intestinal permeability with opposite regional/pH-dependency was obtained, a downward trend for glipizide, and an upward trend for metoprolol. Yet the lowest permeability of glipizide (terminal Ileum) was comparable to the lowest permeability of metoprolol (proximal jejunum). At the colon, similar permeability was evident for glipizide and metoprolol, that was higher than metoprolol's jejunal permeability. We present an analysis that identifies metoprolol's jejunal permeability as the low/high permeability class benchmark anywhere throughout the intestinal tract; we show that the permeability of both glipizide and metoprolol matches/exceeds this threshold throughout the entire intestinal tract, accounting for their success as controlled-release dosage form. This represents a key biopharmaceutical characteristic for a successful controlled-release dosage form. Copyright © 2015 Elsevier B.V. All rights reserved.

Large-scale gene function analysis with the PANTHER classification system.

Science.gov (United States)

Mi, Huaiyu; Muruganujan, Anushya; Casagrande, John T; Thomas, Paul D

2013-08-01

The PANTHER (protein annotation through evolutionary relationship) classification system (http://www.pantherdb.org/) is a comprehensive system that combines gene function, ontology, pathways and statistical analysis tools that enable biologists to analyze large-scale, genome-wide data from sequencing, proteomics or gene expression experiments. The system is built with 82 complete genomes organized into gene families and subfamilies, and their evolutionary relationships are captured in phylogenetic trees, multiple sequence alignments and statistical models (hidden Markov models or HMMs). Genes are classified according to their function in several different ways: families and subfamilies are annotated with ontology terms (Gene Ontology (GO) and PANTHER protein class), and sequences are assigned to PANTHER pathways. The PANTHER website includes a suite of tools that enable users to browse and query gene functions, and to analyze large-scale experimental data with a number of statistical tests. It is widely used by bench scientists, bioinformaticians, computer scientists and systems biologists. In the 2013 release of PANTHER (v.8.0), in addition to an update of the data content, we redesigned the website interface to improve both user experience and the system's analytical capability. This protocol provides a detailed description of how to analyze genome-wide experimental data with the PANTHER classification system.

Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry.

Science.gov (United States)

Beck, Alain; Reichert, Janice M

2013-01-01

In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion's Remsima® and Hospira's Inflectra®), and recommended that they be approved for marketing in the European Union (EU). The European Commission's decision on an application is typically issued 67 d after an opinion is provided; thus, decisions are expected in early September 2013. If approved, the products will comprise the first biosimilar antibody made available to patients in a highly regulated market, although launch may be delayed due to an extension of the reference product's (Remicade®) patent in the EU.

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.

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.

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

Monitoring nanotechnology using patent classifications: an overview and comparison of nanotechnology classification schemes

Energy Technology Data Exchange (ETDEWEB)

Jürgens, Björn, E-mail: bjurgens@agenciaidea.es [Agency of Innovation and Development of Andalusia, CITPIA PATLIB Centre (Spain); Herrero-Solana, Victor, E-mail: victorhs@ugr.es [University of Granada, SCImago-UGR (SEJ036) (Spain)

2017-04-15

Patents are an essential information source used to monitor, track, and analyze nanotechnology. When it comes to search nanotechnology-related patents, a keyword search is often incomplete and struggles to cover such an interdisciplinary discipline. Patent classification schemes can reveal far better results since they are assigned by experts who classify the patent documents according to their technology. In this paper, we present the most important classifications to search nanotechnology patents and analyze how nanotechnology is covered in the main patent classification systems used in search systems nowadays: the International Patent Classification (IPC), the United States Patent Classification (USPC), and the Cooperative Patent Classification (CPC). We conclude that nanotechnology has a significantly better patent coverage in the CPC since considerable more nanotechnology documents were retrieved than by using other classifications, and thus, recommend its use for all professionals involved in nanotechnology patent searches.

Monitoring nanotechnology using patent classifications: an overview and comparison of nanotechnology classification schemes

International Nuclear Information System (INIS)

Jürgens, Björn; Herrero-Solana, Victor

2017-01-01

Patents are an essential information source used to monitor, track, and analyze nanotechnology. When it comes to search nanotechnology-related patents, a keyword search is often incomplete and struggles to cover such an interdisciplinary discipline. Patent classification schemes can reveal far better results since they are assigned by experts who classify the patent documents according to their technology. In this paper, we present the most important classifications to search nanotechnology patents and analyze how nanotechnology is covered in the main patent classification systems used in search systems nowadays: the International Patent Classification (IPC), the United States Patent Classification (USPC), and the Cooperative Patent Classification (CPC). We conclude that nanotechnology has a significantly better patent coverage in the CPC since considerable more nanotechnology documents were retrieved than by using other classifications, and thus, recommend its use for all professionals involved in nanotechnology patent searches.

CLASSIFICATION OF THE MGR WASTE HANDLING BUILDING ELECTRICAL 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 handling building electrical 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)

CLASSIFICATION OF THE MGR OPERATIONS MONITORING AND CONTROL 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) Operations Monitoring and Control 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)

An indigenous soil classification system for Bellona Island - a raised atoll in the Solomon Islands

DEFF Research Database (Denmark)

Elberling, Bo; Breuning-Madsen, Henrik; Bruun, Thilde Bech

2010-01-01

One of the challenges of evaluating existing traditional farming systems is to combine local knowledge and modern scientific methods and terminology. This requires an evaluation of indigenous soil classification in modern terms. This paper focuses on an indigenous soil classification system...... perceive the same four out of seven soil types as highly useful for cultivation and rank these soil types similarly according to their suitability for different crops such as yam, watermelon, cassava and sweet potato. It is concluded that the indigenous soil classification is in line with the soil...... production potential and useful for land evaluation on Bellona....

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

A new classification system for all-ceramic and ceramic-like restorative materials.

Science.gov (United States)

Gracis, Stefano; Thompson, Van P; Ferencz, Jonathan L; Silva, Nelson R F A; Bonfante, Estevam A

2015-01-01

Classification systems for all-ceramic materials are useful for communication and educational purposes and warrant continuous revisions and updates to incorporate new materials. This article proposes a classification system for ceramic and ceramic-like restorative materials in an attempt to systematize and include a new class of materials. This new classification system categorizes ceramic restorative materials into three families: (1) glass-matrix ceramics, (2) polycrystalline ceramics, and (3) resin-matrix ceramics. Subfamilies are described in each group along with their composition, allowing for newly developed materials to be placed into the already existing main families. The criteria used to differentiate ceramic materials are based on the phase or phases present in their chemical composition. Thus, an all-ceramic material is classified according to whether a glass-matrix phase is present (glass-matrix ceramics) or absent (polycrystalline ceramics) or whether the material contains an organic matrix highly filled with ceramic particles (resin-matrix ceramics). Also presented are the manufacturers' clinical indications for the different materials and an overview of the different fabrication methods and whether they are used as framework materials or monolithic solutions. Current developments in ceramic materials not yet available to the dental market are discussed.

Modulation classification for MIMO systems: State of the art and research directions

International Nuclear Information System (INIS)

Bahloul, Mohammad Rida; Yusoff, Mohd Zuki; Abdel-Aty, Abdel-Haleem; Saad, M. Naufal M.; Al-Jemeli, Marwan

2016-01-01

Blind techniques and algorithms for Multiple-Input Multiple-Output (MIMO) signals interception have recently attracted a great deal of research efforts. This is due to their important applications in the military and civil telecommunications domains. One essential step in the signal interception process is to blindly recognize the modulation scheme of the MIMO signals. This process is formally called Modulation Classification (MC). This paper discusses the modulation classification for MIMO systems and presents a comprehensive and critical literature review of the existing MC algorithms for MIMO systems; where possible, gaps in the knowledge base are identified and future directions for the research work are suggested.

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.

A Challenge to Change: Necessary Changes in the Library Classification System for the Chicago Public Schools.

Science.gov (United States)

Williams, Florence M.

This report addresses the feasibility of changing the classification of library materials in the Chicago Public School libraries from the Dewey Decimal classification system (DDC) to the Library of Congress system (LC), thus patterning the city school libraries after the Chicago Public Library and strengthening the existing close relationship…

RFID sensors as the common sensing platform for single-use biopharmaceutical manufacturing

International Nuclear Information System (INIS)

Potyrailo, Radislav A; Surman, Cheryl; Monk, David; Morris, William G; Wortley, Timothy; Vincent, Mark; Diana, Rafael; Pizzi, Vincent; Carter, Jeffrey; Gach, Gerard; Klensmeden, Staffan; Ehring, Hanno

2011-01-01

The lack of reliable single-use sensors prevents the biopharmaceutical industry from fully embracing single-use biomanufacturing processes. Sensors based on the same detection platform for all critical parameters in single-use bioprocess components would be highly desirable to significantly simplify their installation, calibration and operation. We review here our approach for passive radio-frequency identification (RFID)-based sensing that does not rely on costly proprietary RFID memory chips with an analog input but rather implements ubiquitous passive 13.56 MHz RFID tags as inductively coupled sensors with at least 16 bit resolution provided by a sensor reader. The developed RFID sensors combine several measured parameters from the resonant sensor antenna with multivariate data analysis and deliver unique capability of multiparameter sensing and rejection of environmental interferences with a single sensor. This general sensing approach provides an elegant solution for both analytical measurement and identification and documentation of the measured location. (topical review)

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)

Artificial neural net system for interactive tissue classification with MR imaging and image segmentation

International Nuclear Information System (INIS)

Clarke, L.P.; Silbiger, M.; Naylor, C.; Brown, K.

1990-01-01

This paper reports on the development of interactive methods for MR tissue classification that permit mathematically rigorous methods for three-dimensional image segmentation and automatic organ/tumor contouring, as required for surgical and RTP planning. The authors investigate a number of image-intensity based tissue- classification methods that make no implicit assumptions on the MR parameters and hence are not limited by image data set. Similarly, we have trained artificial neural net (ANN) systems for both supervised and unsupervised tissue classification

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...

Clinical Trial Data as Public Goods: Fair Trade and the Virtual Knowledge Bank as a Solution to the Free Rider Problem - A Framework for the Promotion of Innovation by Facilitation of Clinical Trial Data Sharing among Biopharmaceutical Companies in the Era of Omics and Big Data.

Science.gov (United States)

Evangelatos, Nikolaos; Reumann, Matthias; Lehrach, Hans; Brand, Angela

2016-01-01

Knowledge in the era of Omics and Big Data has been increasingly conceptualized as a public good. Sharing of de-identified patient data has been advocated as a means to increase confidence and public trust in the results of clinical trials. On the other hand, research has shown that the current research and development model of the biopharmaceutical industry has reached its innovation capacity. In response to that, the biopharmaceutical industry has adopted open innovation practices, with sharing of clinical trial data being among the most interesting ones. However, due to the free rider problem, clinical trial data sharing among biopharmaceutical companies could undermine their innovativeness. Based on the theory of public goods, we have developed a commons arrangement and devised a model, which enables secure and fair clinical trial data sharing over a Virtual Knowledge Bank based on a web platform. Our model uses data as a virtual currency and treats knowledge as a club good. Fair sharing of clinical trial data over the Virtual Knowledge Bank has positive effects on the innovation capacity of the biopharmaceutical industry without compromising the intellectual rights, proprietary interests and competitiveness of the latter. The Virtual Knowledge Bank is a sustainable and self-expanding model for secure and fair clinical trial data sharing that allows for sharing of clinical trial data, while at the same time it increases the innovation capacity of the biopharmaceutical industry. © 2016 S. Karger AG, Basel.

A novel processed food classification system applied to Australian food composition databases.

Science.gov (United States)

O'Halloran, S A; Lacy, K E; Grimes, C A; Woods, J; Campbell, K J; Nowson, C A

2017-08-01

The extent of food processing can affect the nutritional quality of foodstuffs. Categorising foods by the level of processing emphasises the differences in nutritional quality between foods within the same food group and is likely useful for determining dietary processed food consumption. The present study aimed to categorise foods within Australian food composition databases according to the level of food processing using a processed food classification system, as well as assess the variation in the levels of processing within food groups. A processed foods classification system was applied to food and beverage items contained within Australian Food and Nutrient (AUSNUT) 2007 (n = 3874) and AUSNUT 2011-13 (n = 5740). The proportion of Minimally Processed (MP), Processed Culinary Ingredients (PCI) Processed (P) and Ultra Processed (ULP) by AUSNUT food group and the overall proportion of the four processed food categories across AUSNUT 2007 and AUSNUT 2011-13 were calculated. Across the food composition databases, the overall proportions of foods classified as MP, PCI, P and ULP were 27%, 3%, 26% and 44% for AUSNUT 2007 and 38%, 2%, 24% and 36% for AUSNUT 2011-13. Although there was wide variation in the classifications of food processing within the food groups, approximately one-third of foodstuffs were classified as ULP food items across both the 2007 and 2011-13 AUSNUT databases. This Australian processed food classification system will allow researchers to easily quantify the contribution of processed foods within the Australian food supply to assist in assessing the nutritional quality of the dietary intake of population groups. © 2017 The British Dietetic Association Ltd.

The reliability and reproducibility of the Hertel classification for comminuted proximal humeral fractures compared with the Neer classification

NARCIS (Netherlands)

Iordens, Gijs I. T.; Mahabier, Kiran C.; Buisman, Florian E.; Schep, Niels W. L.; Muradin, Galied S. R.; Beenen, Ludo F. M.; Patka, Peter; van Lieshout, Esther M. M.; den Hartog, Dennis

2016-01-01

The Neer classification is the most commonly used fracture classification system for proximal humeral fractures. Inter- and intra-observer agreement is limited, especially for comminuted fractures. A possibly more straightforward and reliable classification system is the Hertel classification. The

Classifications of Patterned Hair Loss: A Review.

Science.gov (United States)

Gupta, Mrinal; Mysore, Venkataram

2016-01-01

Patterned hair loss is the most common cause of hair loss seen in both the sexes after puberty. Numerous classification systems have been proposed by various researchers for grading purposes. These systems vary from the simpler systems based on recession of the hairline to the more advanced multifactorial systems based on the morphological and dynamic parameters that affect the scalp and the hair itself. Most of these preexisting systems have certain limitations. Currently, the Hamilton-Norwood classification system for males and the Ludwig system for females are most commonly used to describe patterns of hair loss. In this article, we review the various classification systems for patterned hair loss in both the sexes. Relevant articles were identified through searches of MEDLINE and EMBASE. Search terms included but were not limited to androgenic alopecia classification, patterned hair loss classification, male pattern baldness classification, and female pattern hair loss classification. Further publications were identified from the reference lists of the reviewed articles.

Classifications of patterned hair loss: a review

Directory of Open Access Journals (Sweden)

Mrinal Gupta

2016-01-01

Full Text Available Patterned hair loss is the most common cause of hair loss seen in both the sexes after puberty. Numerous classification systems have been proposed by various researchers for grading purposes. These systems vary from the simpler systems based on recession of the hairline to the more advanced multifactorial systems based on the morphological and dynamic parameters that affect the scalp and the hair itself. Most of these preexisting systems have certain limitations. Currently, the Hamilton-Norwood classification system for males and the Ludwig system for females are most commonly used to describe patterns of hair loss. In this article, we review the various classification systems for patterned hair loss in both the sexes. Relevant articles were identified through searches of MEDLINE and EMBASE. Search terms included but were not limited to androgenic alopecia classification, patterned hair loss classification, male pattern baldness classification, and female pattern hair loss classification. Further publications were identified from the reference lists of the reviewed articles.

A support vector machine integrated system for the classification of operation anomalies in nuclear components and systems

International Nuclear Information System (INIS)

Rocco S, Claudio M.; Zio, Enrico

2007-01-01

A support vector machine (SVM) approach to the classification of transients in nuclear power plants is presented. SVM is a machine-learning algorithm that has been successfully used in pattern recognition for cluster analysis. In the present work, single- and multiclass SVM are combined into a hierarchical structure for distinguishing among transients in nuclear systems on the basis of measured data. An example of application of the approach is presented with respect to the classification of anomalies and malfunctions occurring in the feedwater system of a boiling water reactor. The data used in the example are provided by the HAMBO simulator of the Halden Reactor Project

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.

Controlling a human-computer interface system with a novel classification method that uses electrooculography signals.

Science.gov (United States)

Wu, Shang-Lin; Liao, Lun-De; Lu, Shao-Wei; Jiang, Wei-Ling; Chen, Shi-An; Lin, Chin-Teng

2013-08-01

Electrooculography (EOG) signals can be used to control human-computer interface (HCI) systems, if properly classified. The ability to measure and process these signals may help HCI users to overcome many of the physical limitations and inconveniences in daily life. However, there are currently no effective multidirectional classification methods for monitoring eye movements. Here, we describe a classification method used in a wireless EOG-based HCI device for detecting eye movements in eight directions. This device includes wireless EOG signal acquisition components, wet electrodes and an EOG signal classification algorithm. The EOG classification algorithm is based on extracting features from the electrical signals corresponding to eight directions of eye movement (up, down, left, right, up-left, down-left, up-right, and down-right) and blinking. The recognition and processing of these eight different features were achieved in real-life conditions, demonstrating that this device can reliably measure the features of EOG signals. This system and its classification procedure provide an effective method for identifying eye movements. Additionally, it may be applied to study eye functions in real-life conditions in the near future.

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

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

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

Construction of the Classification and Grading Index System of Cultivated Land Based on the Viewpoint of Sustainable Development

Institute of Scientific and Technical Information of China (English)

2010-01-01

In order to objectively and reasonably evaluate the actual and potential value of cultivated land, both social and ecological values are introduced into the classification and grading index system of cultivated land based on the viewpoint of sustainable development, after considering the natural and economic values of cultivated land. Index system construction of the sustainable utilization of cultivated land should follow the principles of economic viability, social acceptability, and ecological protection. Classification of cultivated land should take into account the soil fertility of cultivated land. Then, grading of cultivated land is carried out from the practical productivity (or potential productivity) of cultivated land. According to the existing classification index system of cultivated land, the soil, natural and environmental factors in plains, mountains and hills are mainly modified in the classification index system of cultivated land. And index systems for the cultivated land classification in plains, mountains and hills are set up. The grading index system of cultivated land is established based on the economic viability (economic value), social acceptability (social value) and protection of cultivated land (ecological value). Quantitative expression of cultivated land grading index is also carried out.

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.

Automated radial basis function neural network based image classification system for diabetic retinopathy detection in retinal images

Science.gov (United States)

Anitha, J.; Vijila, C. Kezi Selva; Hemanth, D. Jude

2010-02-01

Diabetic retinopathy (DR) is a chronic eye disease for which early detection is highly essential to avoid any fatal results. Image processing of retinal images emerge as a feasible tool for this early diagnosis. Digital image processing techniques involve image classification which is a significant technique to detect the abnormality in the eye. Various automated classification systems have been developed in the recent years but most of them lack high classification accuracy. Artificial neural networks are the widely preferred artificial intelligence technique since it yields superior results in terms of classification accuracy. In this work, Radial Basis function (RBF) neural network based bi-level classification system is proposed to differentiate abnormal DR Images and normal retinal images. The results are analyzed in terms of classification accuracy, sensitivity and specificity. A comparative analysis is performed with the results of the probabilistic classifier namely Bayesian classifier to show the superior nature of neural classifier. Experimental results show promising results for the neural classifier in terms of the performance measures.

Rational design and optimization of downstream processes of virus particles for biopharmaceutical applications: current advances.

Science.gov (United States)

Vicente, Tiago; Mota, José P B; Peixoto, Cristina; Alves, Paula M; Carrondo, Manuel J T

2011-01-01

The advent of advanced therapies in the pharmaceutical industry has moved the spotlight into virus-like particles and viral vectors produced in cell culture holding great promise in a myriad of clinical targets, including cancer prophylaxis and treatment. Even though a couple of cases have reached the clinic, these products have yet to overcome a number of biological and technological challenges before broad utilization. Concerning the manufacturing processes, there is significant research focusing on the optimization of current cell culture systems and, more recently, on developing scalable downstream processes to generate material for pre-clinical and clinical trials. We review the current options for downstream processing of these complex biopharmaceuticals and underline current advances on knowledge-based toolboxes proposed for rational optimization of their processing. Rational tools developed to increase the yet scarce knowledge on the purification processes of complex biologicals are discussed as alternative to empirical, "black-boxed" based strategies classically used for process development. Innovative methodologies based on surface plasmon resonance, dynamic light scattering, scale-down high-throughput screening and mathematical modeling for supporting ion-exchange chromatography show great potential for a more efficient and cost-effective process design, optimization and equipment prototyping. Copyright © 2011 Elsevier Inc. All rights reserved.

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....

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.

The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers

OpenAIRE

Parr, Alan; Hidalgo, Ismael J.; Bode, Chris; Brown, William; Yazdanian, Mehran; Gonzalez, Mario A.; Sagawa, Kazuko; Miller, Kevin; Jiang, Wenlei; Stippler, Erika S.

2015-01-01

Purpose Currently, the FDA allows biowaivers for Class I (high solubility and high permeability) and Class III (high solubility and low permeability) compounds of the Biopharmaceutics Classification System (BCS). Scientific evidence should be provided to support biowaivers for BCS Class I and Class III (high solubility and low permeability) compounds. Methods Data on the effects of excipients on drug permeability are needed to demonstrate that commonly used excipients do not affect the permea...

Scientific Perspectives on Extending the Provision for Waivers of In vivo Bioavailability and Bioequivalence Studies for Drug Products Containing High Solubility-Low Permeability Drugs (BCS-Class 3)

OpenAIRE

Stavchansky, Salomon

2008-01-01

Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA–BE) studies that appeared in the guidance published by the Food and Drug Administration (FDA) (1) to pharmaceutical products containing Class 3 drugs (High solubility–Low Permeability). The extension of the Biopharmaceutics Classification System (BCS) to Class 3 drugs is meritorious because of its impact on public health policy considerations. The rate limiting ...

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.

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.

Validation of a systems-actuarial computer process for multidimensional classification of child psychopathology.

Science.gov (United States)

McDermott, P A; Hale, R L

1982-07-01

Tested diagnostic classifications of child psychopathology produced by a computerized technique known as multidimensional actuarial classification (MAC) against the criterion of expert psychological opinion. The MAC program applies series of statistical decision rules to assess the importance of and relationships among several dimensions of classification, i.e., intellectual functioning, academic achievement, adaptive behavior, and social and behavioral adjustment, to perform differential diagnosis of children's mental retardation, specific learning disabilities, behavioral and emotional disturbance, possible communication or perceptual-motor impairment, and academic under- and overachievement in reading and mathematics. Classifications rendered by MAC are compared to those offered by two expert child psychologists for cases of 73 children referred for psychological services. Experts' agreement with MAC was significant for all classification areas, as was MAC's agreement with the experts held as a conjoint reference standard. Whereas the experts' agreement with MAC averaged 86.0% above chance, their agreement with one another averaged 76.5% above chance. Implications of the findings are explored and potential advantages of the systems-actuarial approach are discussed.

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

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......) 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...... and external validation by the ISTAP group. The subjects were approached in their place of work and invited to participate in the study and to attend an educational session related to skin tears. RESULTS: The Danish translation of the ISTAP classification system was tested on 270 non-wound specialists...

The rise of a novel classification system for endometrial carcinoma; integration of molecular subclasses.

Science.gov (United States)

McAlpine, Jessica; Leon-Castillo, Alicia; Bosse, Tjalling

2018-04-01

Endometrial cancer is a clinically heterogeneous disease and it is becoming increasingly clear that this heterogeneity may be a function of the diversity of the underlying molecular alterations. Recent large-scale genomic studies have revealed that endometrial cancer can be divided into at least four distinct molecular subtypes, with well-described underlying genomic aberrations. These subtypes can be reliably delineated and carry significant prognostic as well as predictive information; embracing and incorporating them into clinical practice is thus attractive. The road towards the integration of molecular features into current classification systems is not without obstacles. Collaborative studies engaging research teams from across the world are working to define pragmatic assays, improve risk stratification systems by combining molecular features and traditional clinicopathological parameters, and determine how molecular classification can be optimally utilized to direct patient care. Pathologists and clinicians caring for women with endometrial cancer need to engage with and understand the possibilities and limitations of this new approach, because integration of molecular classification of endometrial cancers is anticipated to become an essential part of gynaecological pathology practice. This review will describe the challenges in current systems of endometrial carcinoma classification, the evolution of new molecular technologies that define prognostically distinct molecular subtypes, and potential applications of molecular classification as a step towards precision medicine and refining care for individuals with the most common gynaecological cancer in the developed world. Copyright © 2018 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd. Copyright © 2018 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.

Second International Conference on Accelerating Biopharmaceutical Development: March 9-12, 2009, Coronado, CA, USA.

Science.gov (United States)

Reichert, Janice M; Jacob, Nitya M; Amanullah, Ashraf

2009-01-01

The Second International Conference on Accelerating Biopharmaceutical Development was held in Coronado, California. The meeting was organized by the Society for Biological Engineering (SBE) and the American Institute of Chemical Engineers (AIChE); SBE is a technological community of the AIChE. Bob Adamson (Wyeth) and Chuck Goochee (Centocor) were co-chairs of the event, which had the theme "Delivering cost-effective, robust processes and methods quickly and efficiently." The first day focused on emerging disruptive technologies and cutting-edge analytical techniques. Day two featured presentations on accelerated cell culture process development, critical quality attributes, specifications and comparability, and high throughput protein formulation development. The final day was dedicated to discussion of technology options and new analysis methods provided by emerging disruptive technologies; functional interaction, integration and synergy in platform development; and rapid and economic purification process development.

Movement imagery classification in EMOTIV cap based system by Naïve Bayes.

Science.gov (United States)

Stock, Vinicius N; Balbinot, Alexandre

2016-08-01

Brain-computer interfaces (BCI) provide means of communications and control, in assistive technology, which do not require motor activity from the user. The goal of this study is to promote classification of two types of imaginary movements, left and right hands, in an EMOTIV cap based system, using the Naïve Bayes classifier. A preliminary analysis with respect to results obtained by other experiments in this field is also conducted. Processing of the electroencephalography (EEG) signals is done applying Common Spatial Pattern filters. The EPOC electrodes cap is used for EEG acquisition, in two test subjects, for two distinct trial formats. The channels picked are FC5, FC6, P7 and P8 of the 10-20 system, and a discussion about the differences of using C3, C4, P3 and P4 positions is proposed. Dataset 3 of the BCI Competition II is also analyzed using the implemented algorithms. The maximum classification results for the proposed experiment and for the BCI Competition dataset were, respectively, 79% and 85% The conclusion of this study is that the picked positions for electrodes may be applied for BCI systems with satisfactory classification rates.

YOUNG PLANETARY NEBULAE: HUBBLE SPACE TELESCOPE IMAGING AND A NEW MORPHOLOGICAL CLASSIFICATION SYSTEM

International Nuclear Information System (INIS)

Sahai, Raghvendra; Villar, Gregory G.; Morris, Mark R.

2011-01-01

Using Hubble Space Telescope images of 119 young planetary nebulae (PNs), most of which have not previously been published, we have devised a comprehensive morphological classification system for these objects. This system generalizes a recently devised system for pre-planetary nebulae, which are the immediate progenitors of PNs. Unlike previous classification studies, we have focused primarily on young PNs rather than all PNs, because the former best show the influences or symmetries imposed on them by the dominant physical processes operating at the first and primary stage of the shaping process. Older PNs develop instabilities, interact with the ambient interstellar medium, and are subject to the passage of photoionization fronts, all of which obscure the underlying symmetries and geometries imposed early on. Our classification system is designed to suffer minimal prejudice regarding the underlying physical causes of the different shapes and structures seen in our PN sample, however, in many cases, physical causes are readily suggested by the geometry, along with the kinematics that have been measured in some systems. Secondary characteristics in our system, such as ansae, indicate the impact of a jet upon a slower-moving, prior wind; a waist is the signature of a strong equatorial concentration of matter, whether it be outflowing or in a bound Keplerian disk, and point symmetry indicates a secular trend, presumably precession, in the orientation of the central driver of a rapid, collimated outflow.