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      • KCI등재
      • KCI등재후보

        Sweetening a Bitter Pill: Of Drug Prices, Drug Delays and Data Exclusivity

        Gabriele Spina Alì 이화여자대학교 생명의료법연구소 2019 Asia Pacific Journal of Health Law & Ethics Vol.12 No.2

        Commentators and social activists vehemently demonize data exclusivity for increasing the price of essential pharmaceuticals beyond the purchasing power of developing countries’ citizens, whereas R&D industries defend it as a necessary instrument for bringing new medicines into the market. The present work adds to the ongoing debate by addressing the topic under the light of the empirical evidence suggesting that low-income countries significantly lag behind Western economies in the introduction of new drugs. Under a policy perspective, the paper reviews in a unitary and comprehensive framework the stance that data exclusivity has a role to play in reducing the international drug lag in developing countries. This paper concludes that empirical evidence does not offer compelling arguments to either uphold or discard drug lag driven data exclusivity claims and there is no room to advocate for data exclusivity as a generalized solution to the international drug lag. In spite of this, developing countries tend to give in to the pressures of their western counterparts and have already accepted data exclusivity in more than 30 bilateral and multilateral free trade agreements. As such, anytime data exclusivity is accepted as a bargaining chip to strike a more favourable trade deal, a health-oriented precautionary approach demands to safeguard those flexibilities that are best fit to strike a balance between intellectual property, affordable medicines and prompt drug introductions. The paper will, therefore, analyse and defend the consistency of six data exclusivity flexibilities with the international intellectual property regime and in particular with the TRIPS Agreement. In doing so, the paper provides developing countries’ governments with some legal and policy arguments in support of data exclusivity flexibilities, with the goal of best protecting the health interests of their populations in the process of implementation and/or negotiation of international data exclusivity provisions.

      • KCI등재

        Analysis of Polymer Crystallization and Residual Stresses in Injection Molded Parts

        Roberto Spina,Marcel Spekowius,Rainer Dahlmann,Christian Hopmann 한국정밀공학회 2014 International Journal of Precision Engineering and Vol. No.

        The main objective of the presented work is to develop an integrated computational environment that predicts final part properties made of semicrystalline thermoplastics. This objective is fulfilled by adopting the following two-step approach: 1) identification of an analytical scheme to correlate crystallization parameters with engineer properties; 2) apply the analytical scheme to the numerical simulation to study the polymer and final properties of the part. In this work the crystallization evolution in cooling phase, mainly influenced by thermal gradients, and its effect on the final part properties are investigated. The numerical method, crystallization models and their implementation into numerical software are described as well as the experimental data.

      • KCI등재

        Analysis of Lens Manufacturing with Injection Molding

        Roberto Spina,Paul Walach,Julian Schild,Christian Hopmann 한국정밀공학회 2012 International Journal of Precision Engineering and Vol. No.

        In the present research, the authors investigated the lens manufacturing with the injection molding process by using the geometrical contour errors as the quality criterion. In order to produce functional injection-molded optical components, a special cavity mold was used to perform experimental testing for biconvex spherical lenses and numerical simulation was used to help during mimic of the process behavior. The approach was divided into validation step and optimization step. In the validation step, a reliable numerical model was designed to reproduce material features during filling and shrinkage, in order to correctly evaluate lens deflection. In the optimization step, the Grey Relational Component analysis coupled to the Taguchi Design was used to identify the optimal parameter set leading to the best values of lens total deflection, Peak-to-Valley and Root Mean Square between real and ideal lens surface geometry.

      • KCI등재후보

        Sweetening a Bitter Pill: Of Drug Prices, Drug Delays and Data Exclusivity

        Gabriele Spina Alì 이화여자대학교 생명의료법연구소 2019 Asia Pacific Journal of Health Law & Ethics Vol.12 No.2

        Commentators and social activists vehemently demonize data exclusivity for increasing the price of essential pharmaceuticals beyond the purchasing power of developing countries’ citizens, whereas R&D industries defend it as a necessary instrument for bringing new medicines into the market. The present work adds to the ongoing debate by addressing the topic under the light of the empirical evidence suggesting that low-income countries significantly lag behind Western economies in the introduction of new drugs. Under a policy perspective, the paper reviews in a unitary and comprehensive framework the stance that data exclusivity has a role to play in reducing the international drug lag in developing countries. This paper concludes that empirical evidence does not offer compelling arguments to either uphold or discard drug lag driven data exclusivity claims and there is no room to advocate for data exclusivity as a generalized solution to the international drug lag. In spite of this, developing countries tend to give in to the pressures of their western counterparts and have already accepted data exclusivity in more than 30 bilateral and multilateral free trade agreements. As such, anytime data exclusivity is accepted as a bargaining chip to strike a more favourable trade deal, a health-oriented precautionary approach demands to safeguard those flexibilities that are best fit to strike a balance between intellectual property, affordable medicines and prompt drug introductions. The paper will, therefore, analyse and defend the consistency of six data exclusivity flexibilities with the international intellectual property regime and in particular with the TRIPS Agreement. In doing so, the paper provides developing countries’ governments with some legal and policy arguments in support of data exclusivity flexibilities, with the goal of best protecting the health interests of their populations in the process of implementation and/or negotiation of international data exclusivity provisions.

      • KCI우수등재

        Mid-infrared (MIR) spectroscopy for the detection of cow’s milk in buffalo milk

        Anna Antonella Spina,Carlotta Ceniti,Cristian Piras,Bruno Tilocca,Domenico Britti,Valeria Maria Morittu 한국축산학회 2022 한국축산학회지 Vol.64 No.3

        In Italy, buffalo mozzarella is a largely sold and consumed dairy product. The fraudulent adulteration of buffalo milk with cheaper and more available milk of other species is very frequent. In the present study, Fourier transform infrared spectroscopy (FTIR), in combination with multivariate analysis by partial least square (PLS) regression, was applied to quantitatively detect the adulteration of buffalo milk with cow milk by using a fully automatic equipment dedicated to the routine analysis of the milk composition. To enhance the heterogeneity, cow and buffalo bulk milk was collected for a period of over three years from different dairy farms. A total of 119 samples were used for the analysis to generate 17 different concentrations of buffalo- cow milk mixtures. This procedure was used to enhance variability and to properly randomize the trials. The obtained calibration model showed an R2 ≥ 0.99 (R2cal. = 0.99861; root mean square error of cross-validation [RMSEC] = 2.04; R2val. = 0.99803; root mean square error of prediction [RMSEP] = 2.84; root mean square error of cross-validation [RMSECV] = 2.44) suggesting that this method could be successfully applied in the routine analysis of buffalo milk composition, providing rapid screening for possible adulteration with cow’s milk at no additional cost.

      • KCI등재
      • Vulnerability assessment of strategic buildings based on ambient vibrations measurements

        Mori, Federico,Spina, Daniele Techno-Press 2015 Structural monitoring and maintenance Vol.2 No.2

        This paper presents a new method for seismic vulnerability assessment of buildings with reference to their operational limit state. The importance of this kind of evaluation arises from the civil protection necessity that some buildings, considered strategic for seismic emergency management, should retain their functionality also after a destructive earthquake. The method is based on the identification of experimental modal parameters from ambient vibrations measurements. The knowledge of the experimental modes allows to perform a linear spectral analysis computing the maximum structural drifts of the building caused by an assigned earthquake. Operational condition is then evaluated by comparing the maximum building drifts with the reference value assigned by the Italian Technical Code for the operational limit state. The uncertainty about the actual building seismic frequencies, typically significantly lower than the ambient ones, is explicitly taken into account through a probabilistic approach that allows to define for the building the Operational Index together with the Operational Probability Curve. The method is validated with experimental seismic data from a permanently monitored public building: by comparing the probabilistic prediction and the building experimental drifts, resulting from three weak earthquakes, the reliability of the method is confirmed. Finally an application of the method to a strategic building in Italy is presented: all the procedure, from ambient vibrations measurement, to seismic input definition, up to the computation of the Operational Probability Curve is illustrated.

      • Upper Paleozoic glacigenic deposits of Gondwana: Stratigraphy and paleoenvironmental significance of a tillite succession in Northern Victoria Land (Antarctica)

        Cornamusini, Gianluca,Talarico, Franco M.,Cirilli, Simonetta,Spina, Amalia,Olivetti, Valerio,Woo, Jusun Elsevier 2017 Sedimentary geology Vol.358 No.-

        <P><B>Abstract</B></P> <P>Late Paleozoic glacial deposits are widespread in Gondwana. In Antarctica the best outcrops occur in the Central Transantarctic Mountains, Ellsworth Mountains, Pensacola Mountains, and in Southern Victoria Land, whereas they are rare and very scattered in Northern Victoria Land, which represents a linkage sector with Tasmania and eastern Australia. The aim of the present research is to define the stratigraphic setting and the environmental interpretation of a poorly studied Lower Permian glacigenic succession located near Orr Glacier in the Lanterman Range in Northern Victoria Land. It has great importance because it represents the only significant glacigenic succession for this wide area, marking and defining time and modality of a glacial-postglacial transition during the early Permian, a critical time-interval in the paleoenvironmental evolution of southern Gondwana. This succession, named here as the Lanterman Formation, lies directly on to crystalline basement, and is overlain by a thick Permian fluvial succession (Takrouna Formation). The results provided by sedimentological facies analysis and palynological analysis, integrated with a limited petrographic characterization, show a correlation framework between two isolated successions, outlining their stratigraphic architecture and subdivided into a lower glacial portion and an upper postglacial portion. The former, Asselian in age, is dominated by diamictite, sandstone, mudstone with lonestones, and carbonate deposits, suggesting repeated advance and retreat of a terrestrial glacier, with facies associations indicating environmental changes from subglacial to glaciofluvial, to glaciolacustrine. The latter is dominated by lacustrine mudstone with decreasing lonestones upward, thin bedded sandstone, conglomerate and a thick fluvial sandstone and pebbly sandstone succession at the top, signalling the transition to a fluvial system through time. The overall dataset suggests that the late Paleozoic glacigenic deposits of Northern Victoria Land record the evolution from a setting characterized by a terrestrial small ice cap that underwent repeated advances and retreats due to climate cycles in a lacustrine setting, into a postglacial paleoenvironmental scenario with a wide fluvial system draining northwards from Victoria Land towards the Tasmanian Basin. The results contribute to increasing knowledge of the timing and modalities of the Late Paleozoic Ice Age in Gondwana, particularly for polar regions such as Antarctica.</P>

      • KCI등재

        A Possible Pathogenic Linkage Among Headache, Migraine, and Nocturnal Enuresis in Children

        Pietro Ferrara,Livia Dell’Aquila,Giacomo Perrone,Giulia Spina,Francesco Miconi,Valentina Rapaccini,Ester Del Vescovo,Vincenzo Di Lazzaro,Alberto Verrotti 대한배뇨장애요실금학회 2016 International Neurourology Journal Vol.20 No.4

        Purpose: This study aims to evaluate the prevalence of headaches and migraine in children with nocturnal enuresis (NE) and to improve knowledge on these conditions. In particular, for this purpose, a possible pathogenic relationship linking both conditions and the impact of headaches and migraine on NE persistence was evaluated. Methods: Researchers enrolled 123 children with NE, aged between 5 and 15 years, referred to the Service of Pediatrics, Campus Bio-Medico University Hospital of Rome between January 2014 and January 2015. Parents of all children enrolled in the study were invited to complete a self-reported questionnaire. The study protocol was approved by the Human Research Ethics Committee of Campus-Bio-Medico University. The NE group data was compared with the data of a control group (107 children). Results: Of the eligible patients, 7.8% suffer from headaches/migraine (mean age, 9.63 years; interquartile range [IQR], 3.5 years) and 47.1% have a family history of headaches (mean age, 8.46 years; IQR, 3.75 years). Of the 8 patients with headaches, all are male, 3 have tension-type headaches (2 of them have maternal family history) and 5 have migraine (3 of them have maternal family history). Of the 35.3% with a migraine family history (mean age, 8.36 years; IQR, 3.5 years), 22 are male, and 14 are female. Three of these patients have migraine. A total of 92.2% suffer from NE but not from headaches (mean age, 8.43 years; IQR, 3 years). Of these patients, 33 are female (35.1%), and 61 are male (64.9%). In the control group, 4.7% (5 out of 107) of the children suffer from headaches, and of these, 4 are affected by nonmigraine headaches and 1 by migraine. Conclusions: In conclusion, according to the hypothesis, NE and headaches/migraine could be linked by several similarities.

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