Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials.

A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI risk associated with new therapeutic agents in clinical trials. There was agreement that in order to achieve this goal the systematic acquisition of protocol-specified clinical measures and lab specimens from all study subjects is crucial. In addition, standard DILI terms that address the diverse clinical and pathologic signatures of DILI were considered essential. There was a strong consensus that clinical and lab analyses necessary for the evaluation of cases of acute liver injury should be consistent with the US Food and Drug Administration (FDA) guidance on pre-marketing risk assessment of DILI in clinical trials issued in 2009. A recommendation that liver injury case review and management be guided by clinicians with hepatologic expertise was made. Of note, there was agreement that emerging DILI signals should prompt the systematic collection of candidate pharmacogenomic, proteomic and/or metabonomic biomarkers from all study subjects. The use of emerging standardized clinical terminology, CRFs and graphic tools for data review to enable harmonization across clinical trials was strongly encouraged. Many of the recommendations made in the breakout session are in alignment with those made in the other parallel sessions on methodology to assess clinical liver safety data, causality assessment for suspected DILI, and liver safety assessment in special populations (hepatitis B, C, and oncology trials). Nonetheless, a few outstanding issues remain for future consideration.

Permanent demand excess as business strategy: an analysis of the Brazilian higher-education market

Many Higher Education Institutions (HEIs) establish tuition below the equilibrium price to generate permanent demand excess. This paper first adapts Becker’s (1991) theory to understand why the HEIs price in this way. The fact that students are both consumers and inputs on the education production process gives rise to a market equilibrium where some firms have excess demand and charge high prices, and others charge low prices and have empty seats.Second, the paper analyzes this equilibrium empirically. We estimated the demand for undergraduate courses in Business Administration in the State of São Paulo. The results show that tuition, quality of incoming students and percentage of lecturers holding doctorates degrees are the determining factors of students’ choice. Since the student quality determines the demand for a HEI, it is calculated what the value is for a HEI to get better students; that is the total revenue that each HEI gives up to guarantee excess demand. Regarding the “investment” in selectivity, 39 HEIs in São Paulo give up a combined R$ 5 million (or US$ 3.14 million) in revenue per year per freshman class, which means 7.6% of the revenue coming from a freshman class.

Art painting Data Collection

The classification of Art painting images is a computer vision applications that isgrowing considerably. The goal of this technology, is to classify an art paintingimage automatically, in terms of artistic style, technique used, or its author. For thispurpose, the image is analyzed extracting some visual features. Many articlesrelated with these problems have been issued, but in general the proposed solutionsare focused in a very specific field. In particular, algorithms are tested using imagesat different resolutions, acquired under different illumination conditions. Thatmakes complicate the performance comparison of the different methods. In thiscontext, it will be very interesting to construct a public art image database, in orderto compare all the existing algorithms under the same conditions. This paperpresents a large art image database, with their corresponding labels according to thefollowing characteristics: title, author, style and technique. Furthermore, a tool thatmanages this database have been developed, and it can be used to extract differentvisual features for any selected image. This data can be exported to a file in CSVformat, allowing researchers to analyze the data with other tools. During the datacollection, the tool stores the elapsed time in the calculation. Thus, this tool alsoallows to compare the efficiency, in computation time, of different mathematicalprocedures for extracting image data.

Marco metodológico para la definición de un perfil profesional en educación superior = Methodological framework for the definition of a professional profile in higher education

En el marco del Espacio Europeo de Educación Superior 1 se inscriben innumerables acciones que están desarrollando todas las universidades europeas con la intención de llegar al 2010 con un bagaje lo suficientemente importante como para afrontar este cambio con entereza y sobretodo conservando (o incrementando) la calidad de los procesos de enseñanza- aprendizaje que hasta el momento han predominado. Dentro de este amplio proceso de transformación se encuentra el diseño de los nuevos Grados que brinda la oportunidad de replantear los planes de estudios, por tanto, la organización de las asignaturas, estructura de los contenidos, metodologías y sistemas de evaluación. Toda esta reflexión debe girar, a nuestro entender, alrededor de tres núcleos que se encuentran en estado deinterdependencia: los escenarios profesionales, los perfiles profesionales y las competencias que en ellos se inscriben.Para poder plantear los nuevos Grados en coherencia con la era del EEES debe hacerse un análisis minucioso de los perfil profesionales demandados por el mercado de trabajo que, al fin y al cabo será el destino de los profesionales que se forman en nuestras universidades, es por ello, que la tarea de definir el perfil profesional a priori del diseño de los nuevos Grados resulta una máxima para garantizar la calidad de estos. En este trabajo se presenta un ejemplo de metodología a seguir para la definición de un perfil profesional en Educación Superior, concretamente, el del Ingeniero TIC mediante el Análisis Funcional.

Overeducation among European university graduates : a comparative analysis ot its incidence and the importance of higher education differentiation

The incidence of over-education is here assessed by applying some standard subjective and objective indicators and a new skill-based indicator of over-education to the national samples of eight European countries in the REFLEX survey. With the exception of Spain, the results reveal that over-education is a minor risk amongst European tertiary graduates. Yet, the contrast between the standard indicators and the skill-based indicator reveals the existence of an over-education of a moderate kind in countries with high tertiary attainment rates (Norway, Finland and Netherlands). Such a type of over-education does not come to the surface when applying the standard indicators. Our results also reveal the importance of higher education differentiation (i.e. field of study and branch of higher education) for understanding the risk of over-education. Graduates from humanistic fields, bachelor courses and vocational colleges are more exposed to over-education, though their disadvantage varies across-nationally to a significant extent.

Analysis of variables that are not directly observable: influence on decision-making during the research process

The sample dimension, types of variables, format used for measurement, and construction of instruments to collect valid and reliable data must be considered during the research process. In the social and health sciences, and more specifically in nursing, data-collection instruments are usually composed of latent variables or variables that cannot be directly observed. Such facts emphasize the importance of deciding how to measure study variables (using an ordinal scale or a Likert or Likert-type scale). Psychometric scales are examples of instruments that are affected by the type of variables that comprise them, which could cause problems with measurement and statistical analysis (parametric tests versus non-parametric tests). Hence, investigators using these variables must rely on suppositions based on simulation studies or recommendations based on scientific evidence in order to make the best decisions.

Higher education and national identity : Polish student activism in Russia 1832-1863

Doctoral dissertation, University of Helsinki

The use of ISO 9001 quality standard in higher education institution libraries

[eng] ISO standard 9001 is one of a set of management tools that libraries have adopted in recent years. This article focuses on libraries in higher education institutions that have received ISO certification of their quality management systems (ISO standard 9001:2000). We examine their reasons for seeking certification and the advantages and difficulties they have encountered in applying this ISO standard. Finally, we consider the future prospects of ISO standard 9001 in university libraries.