Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010)

AbstractThe WHO guidelines on evaluating similar biotherapeutic products (SBPs) were adopted by the Expert Committee on Biological Standardization in 2009. The fundamental messages of the guidelines are that a) generic approach is not suitable for licensing SBPs, b) only products that have been subjected to a comparability exercise and show similarity to the reference biotherapeutic product (RBP) in terms of their quality, safety and efficacy are defined as SBPs, and c) the products that are not shown to be similar to the originator products as indicated in the guidelines should neither be described as "similar" nor called SBPs. In view of these, the products which have not been subjected to a head to head comparison with the RBP should be referred to as another term, e.g. ‘non-innovator’ therapeutic products.In order to review the current situation in each country, a survey was planned in line with the implementation workshop of the guidelines in August 2010. The results show that the diversity of regulatory framework for licensing SBPs and the ambiguous use of the terms, ‘similar’ or ‘generic’, present considerable challenges for the future use of SBPs

South Korean Nurses to West Germany: Reassessing the Role of the State in Postwar Global Labour Migration

Between the mid-1950s and the mid-1970s, 12,000 South Korean women worked as nurses in West Germany. Focusing on this migration allows for a reassessment of the role of the state in international labour migration prior to the era of globalization post-1980. Although Cold War politics shaped the diplomatic relationships that channeled South Korean nurses to West Germany, and contrary to narratives that celebrate the South Korean state’s central role in exporting female labour as the basis for South Korea’s economic miracle in the decades after the Korean War, the South Korean state played no direct role in the migration of nurses from South Korea to West Germany. South Korean nurses moved largely through the interventions not of the state but of private Catholic actors and not in the interests of South Korea’s economy but out of personal economic motivations.Entre le milieu des années 1950 et le milieu des années 1970, 12 000 Sud-Coréennes ont travaillé comme infirmières en Allemagne de l’Ouest. Attirer l’attention sur cette migration permet de réévaluer le rôle de l’État dans la migration internationale de travailleurs antérieure à la mondialisation d’après 1980. La politique de la guerre froide a certes façonné les relations diplomatiques qui ont conduit des infirmières sud-coréennes en Allemagne de l’Ouest, mais, contrairement au discours qui salue le rôle central de l’État sud-coréen dansl’exportation de main-d’oeuvre féminine et voit là le fondement du miracle économique survenu dans ce pays après la guerre de Corée, l’État sud-coréen n’a joué aucun rôle direct dans la migration de ses infirmières en Allemagne de l’Ouest. C’est surtout l’action d’intervenants catholiques privés et non celle de l’État qui a amené les infirmières sud-coréennes à agir ainsi, poussées par des raisons économiques personnelles et non par l’intérêt économique de leur pays

Part of Speech Tagging Guidelines for Penn Korean Treebank

This document describes the Part-of-Speech (POS) tagging guidelines for the Penn Korean Treebank Project. The corpus used for this project consists of around 54,000 words and 5,000 sentences. This document starts with a summary of the tagset used in the Penn Korean Treebank, followed by a more detailed discussion of each tag with examples. Then pairs of tags that are easily confused with each other are discussed and guidelines on how to distinguish one from the other for a given base forms and inflections are presented. The document concludes with a list of specific problematic examples with guidelines on how to handle such cases

Design And Fabrication Of Particle-Embedded Polymer Composite Films For Optimized Light-Modulation

ABSTRACT In this dissertation, we develop new composite optical materials by the assembly of silica nanoparticles (NPs) into micron-scaled geometries and embedding them into selected polymer media to achieve tunable and synergistic optical properties for potential applications, including photovoltaics, photobioreactors, or solar-integrated smart windows. The size and the refractive index of NPs, and the geometric arrangements are explored to optimize the targeted optical properties, including forward scattering and the reflectance of light. We also explore different types of the polymer matrix to allow for matching refractive index or introducing stimuli-responsive light scattering. Firstly, we develop a novel design of semi-transparent composite films for delivering equal and optimally efficient “doses” of sunlight to photosynthetic cells, algae, in a photobioreactor system. The efficient re-distribution of solar flux can allow the algae to receive spatially diluted solar flux and thus avoid photodamages from the direct sunlight. We develop colloidal NPs are assembled into microspheres via water-based emulsion evaporation method which is easy to set up and suitable for large-scale fabrication. Backed by numerical calculations, the overall shape/size of the microsphere and the effective refractive index of the composites are optimized, the synthetic scatterers that recapitulate the salient forward-scattering behavior of the Tridacnid clam system are presented. These hierarchically structured beads also generate various structural colors due to the periodic packing of NPs, which allows back-reflection of photosynthetically inefficient green or yellow lights depending on the sizes of NPs. Our method is simple yet scalable, cost-effective, and environmentally benign, which inspires new designs for small-footprint biofuel applications. Secondly, we develop new strategies to tune the optical transmittance via mechano-responsive polymers. Stretchable smart window film consisting of an elastomer with micro-scale wrinkles and silica (SiO2) NPs can provide reversible and switchable transparency-opacity. We design and fabricate mechanically responsive films composed of silica NPs and elastomers. By incorporating deformable and controllable wrinkling patterns into the particle-embedded polymer systems with wrinkles and NPs on opposite side of the films, we achieve the desired transparency at a low mechanical strain (\u3c 20%) without wasting energy. The wavelength, amplitude of wrinkles as well as their local ordering can be fine-tuned by the pre-strain vs. applied strain, particle size, oxygen plasma treatment intensity and time, thus, changing the total amount of light refracted from the curved surfaces. We note that since the nano-/micron-sized voids are created at the interface between NPs and polymer matrix upon stretching, they act as light scatters to “reveal” the embedded structural colors, resulting in drastic transparency-opacity switching. Besides, we fabricate the particle-embedded PDMS composite films with wrinkles on the same side of NPs and demonstrate their mechano-responsive optical properties. We confirm that the formation of ordered wrinkling patterns is impeded by the presence of particles on the surface and the homogeneity of wrinkle formation is increased by higher pre-stretch strain and longer plasma exposure time. Thus, we tune the optical transmittance of films by varying the pre-strains and the size of NPs separately. Our material designs offer new insights on how to fine-tune optical properties with minimal energy consumption for applications including on-demand smart windows and strain sensors

Shaping nanoparticle fingerprints at the interface of cholesteric droplets

The ordering of nanoparticles into predetermined configurations is of importance to the design of advanced technologies. In this work, we moderate the surface anchoring against the bulk elasticity of liquid crystals to dynamically shape nanoparticle assemblies at a fluid interface. By tuning the degree of nanoparticle hydrophobicity with surfactants that alter the molecular anchoring of liquid crystals, we pattern nanoparticles at the interface of cholesteric liquid crystal emulsions. Adjusting the particle hydrophobicity more finely further modifies the rigidity of assemblies. We establish that patterns are tunable by varying both surfactant and chiral dopant concentrations. Since particle assembly occurs at the interface with the desired structures exposed to the surrounding phase, we demonstrate that particles can be readily crosslinked and manipulated, forming structures that retain their shape under external perturbations. This study establishes the templating of nanomaterials into reconfigurable arrangements. Interfacial assembly is tempered by elastic patterns that arise from the geometric frustration of confined cholesterics. This work serves as a basis for creating materials with chemical heterogeneity and with linear, periodic structures, essential for optical and energy applications.Comment: 16 pages with 5 figures, 4 page supplementary with 5 supplementary figure

Bracketing Guidelines for Penn Korean TreeBank

This document describes the syntactic bracketing guidelines for the Penn Korean Treebank, which is an online corpus of Korean texts annotated with morphological and syntactic information. The corpus consists of around 54,000 words and 5,000 sentences. The Treebank uses a phrase structure style of annotation, making head/phrasal node distinctions, argument/adjunct distinctions, and identifying empty arguments and traces for moved constituents. This document is organized as follows. In section 2, the basic syntactic ingredients of a clause structure are presented. Some notational conventions are introduced in section 3, including different types of syntactic tags, such as head level tags, phrase level tags and function tags used in the Treebank. In section 4, the bracketing guidelines for various types of clauses are discussed, including simple clauses, subordinate clauses, and clauses with coordination. Several types of subcategorizaion frames found in the Treebank are then presented in section 5, followed by bracketing guidelines for various linguistic phenomena in sections 6 to 21, including guidelines for annotating punctuation. The document ends with guidelines for handling some bracketing ambiguities and for handling some confusing examples

Curcumin induces expression of 15-hydroxyprostaglandin dehydrogenase in gastric mucosal cells and mouse stomach in vivo: AP-1 as a potential target

15-Hydroxyprostaglandin dehydrogenase (15-PGDH) catalyzes the conversion of oncogenic prostaglandin E-2 to non-tumerigenic 15-keto prostaglandin E-2. In the present study, we found that curcumin, a yellow coloring agent present in the rhizome of Curcuma Tonga Linn (Zingiberaceae), induced expression of 15-PGDH at the both transcriptional and translational levels in normal rat gastric mucosal cells. By using deletion constructs of 15-PGDH promoter, we were able to demonstrate that activator protein-1 (AP-1) is the principal transcription factor responsible for regulating curcumin-induced 15-PGDH expression. Curcumin enhanced the expression of c-jun and cFos that are functional subunits of AP-1, in the nuclear fraction of cells. Silencing of c-jun suppressed curcumin-induced expression of 15-PGDH. Moreover, the chromatin immunoprecipitation assay revealed curcumin-induced binding of c-Jun to the AP-1 consensus sequence present in the 15-PGDH promoter. Curaimin increased phosphorylation of ERK1/2 and JNK. and pharmacologic inhibition of these kinases abrogated the curcumin-induced phosphorylation of clun and 15-PGDH expression. In contrast, tetrahydrocurcumin which lacks the alpha,beta-unsaturated carbonyl group failed to induce 15-PGDH expression, suggesting that the electrophilic carbonyl group of curcumin is essential for its induction of 15-PGDH expression. Curcumin restored the expression of 15-PGDH which is down-regulated by Helicobater pylori through suppression of DNA methyltransferase 1. In addition, oral administration of curcumin increased the expression of 15-PGDH and its regulators such as p-ERK1/2, p-JNK and c-Jun in the mouse stomach. Taken together, these findings suggest that curcumin-induced upregulation of 15-PGDH may contribute to chemopreventive effects of this phytochemical on inflammation-associated gastric carcinogenesis. (C) 2020 Elsevier Inc. All rights reserved.