Impact of the council of europe resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients

Introduction and objective: The regulation of pharmacy preparations, especially for standards for quality assurance and safety, is not harmonised across Europe and falls under the national competencies of individual states. There are concerns about quality control and safety for the medicinal products made in pharmacies, which is widespread in European countries. There are, however, good reasons to continue this practice, which is able to tailor preparations to the specific needs of a particular patient or patient group and to provide a supplementary source of supply when an industrially manufactured product, which is authorised for marketing is not available or when there are temporary shortages of licensed medicines. In seeking to provide guidelines for legislation and acting on the advice of an expert group dealing in pharmaceutical practices, the Committee of Ministers of the Council of Europe passed a resolution in 2011. The Council of Europe Resolution provides authorities and pharmacists with the means to reinforce safety measures for medicinal products prepared in pharmacies and to harmonise quality assurance and safety standards. It dealt with aspects of pharmacy preparation such as quality standards for preparation and distribution, marketing authorisation, product dossiers, labelling, reporting, and safety. In 2013 and 2014 the Committee of Experts carried out a survey to evaluate the impact of the resolution within a cross section of member states,Methods: In the resolution of 2011 the member states were recommended to adapt their legislation in line with its provisions. The survey that was carried out in 2013 and 2014 followed the recommendations in the reso-lution. A questionnaire was made and sent to across section of member states.Results: Among the member states involved, the results of this survey show a clear commitment to imple-ment the recommendations of the resolution.Conclusions: This report presents the results of the survey with a discussion of outstanding issues

Low Temperature Expansions for Potts Models

On simple cubic lattices, we compute low temperature series expansions for the energy, magnetization and susceptibility of the three-state Potts model in D=2 and D=3 to 45 and 39 excited bonds respectively, and the eight-state Potts model in D=2 to 25 excited bonds. We use a recursive procedure which enumerates states explicitly. We analyze the series using Dlog Pade analysis and inhomogeneous differential approximants.Comment: (17 pages + 8 figures

Modeling of Cu oxidation in adiabatic fixed-bed reactor with N2 recycling in a Ca/Cu chemical loop

A dynamic model has been constructed to describe the Cu oxidation reaction within a large-scale Cu/CuO chemical looping process in adiabatic fixed-bed reactors. Careful control of the temperature is required during Cu oxidation because of its high reaction enthalpy. The recycling of a large amount of nitrogen, previously cooled down, and its mixture with air for Cu oxidation regulates the temperature in the reaction front, ensuring that undesirable hot spots that would lead to the irreversible loss of Cu activity are avoided. Since the gas/solid heat exchange front advances faster than the reaction front, the bed is eventually left at a low temperature. An additional stage was added to allow a gas/solid heat exchange between the hot recycled gas and the oxidized bed. This ensures that the fixed-bed is ready for the next reaction step that involves the reduction of CuO by a fuel gas. A sensitivity analysis of the main operating parameters confirms the theoretical viability of this operation. Cu oxidation is favored at high pressure and therefore fast reaction rates were achieved, even with low contents of oxygen in the feed (around 3–4%). The recirculation of more than 80% of the exit gas from the oxidation reactor and its subsequent cooling down to around 423 K keep the maximum temperature down to within reasonable values (1173 K). Although this work was focused on the boundary conditions of the Ca/Cu looping process for hydrogen production and/or power generation, some of the trends observed may be considered valid for other CLC systems that use similar N2 recycles.The authors acknowledge the grant awarded by the Spanish Science and Innovation Ministry under the project ENE2009-11353 and CSIC (201280E017).Peer reviewe

Kondo Effect in a Metal with Correlated Conduction Electrons: Diagrammatic Approach

We study the low-temperature behavior of a magnetic impurity which is weakly coupled to correlated conduction electrons. To account for conduction electron interactions a diagrammatic approach in the frame of the 1/N expansion is developed. The method allows us to study various consequences of the conduction electron correlations for the ground state and the low-energy excitations. We analyse the characteristic energy scale in the limit of weak conduction electron interactions. Results are reported for static properties (impurity valence, charge susceptibility, magnetic susceptibility, and specific heat) in the low-temperature limit.Comment: 16 pages, 9 figure

Auditory brainstem measures and genotyping boost the prediction of literacy : a longitudinal study on early markers of dyslexia

Literacy acquisition is impaired in children with developmental dyslexia resulting in lifelong struggle to read and spell. Proper diagnosis is usually late and commonly achieved after structured schooling started, which causes delayed interventions. Legascreen set out to develop a preclinical screening to identify children at risk of developmental dyslexia. To this end we examined 93 preliterate German children, half of them with a family history of dyslexia and half of them without a family history. We assessed standard demographic and behavioral precursors of literacy, acquired saliva samples for genotyping, and recorded speech-evoked brainstem responses to add an objective physiological measure. Reading and spelling was assessed after two years of structured literacy instruction. Multifactorial regression analyses considering demographic information, genotypes, and auditory brainstem encoding, predicted children’s literacy skills to varying degrees. These predictions were improved by adding the standard psychometrics with a slightly higher impact on spelling compared to reading comprehension. Our findings suggest that gene-brain-behavior profiling has the potential to determine the risk of developmental dyslexia. At the same time our results imply the need for a more sophisticated assessment to fully account for the disparate cognitive profiles and the multifactorial basis of developmental dyslexia

Landscape science: a Russian geographical tradition

The Russian geographical tradition of landscape science (landshaftovedenie) is analyzed with particular reference to its initiator, Lev Semenovich Berg (1876-1950). The differences between prevailing Russian and Western concepts of landscape in geography are discussed, and their common origins in German geographical thought in the late nineteenth and early twentieth centuries are delineated. It is argued that the principal differences are accounted for by a number of factors, of which Russia's own distinctive tradition in environmental science deriving from the work of V. V. Dokuchaev (1846-1903), the activities of certain key individuals (such as Berg and C. O. Sauer), and the very different social and political circumstances in different parts of the world appear to be the most significant. At the same time it is noted that neither in Russia nor in the West have geographers succeeded in specifying an agreed and unproblematic understanding of landscape, or more broadly in promoting a common geographical conception of human-environment relationships. In light of such uncertainties, the latter part of the article argues for closer international links between the variant landscape traditions in geography as an important contribution to the quest for sustainability

Disentangling the effect of farming practice and aridity on crop stable isotope values: a present-day model from Morocco and its application to early farming sites in the eastern Mediterranean

Agriculture has played a pivotal role in shaping landscapes, soils and vegetation. Developing a better understanding of early farming practices can contribute to wider questions regarding the long-term impact of farming and its nature in comparison with present-day traditional agrosystems. In this study we determine stable carbon and nitrogen isotope values of barley grains from a series of present-day traditionally managed farming plots in Morocco, capturing a range of annual rainfall and farming practices. This allows a framework to be developed to refine current isotopic approaches used to infer manuring intensity and crop water status in (semi-)arid regions. This method has been applied to charred crop remains from two early farming sites in the eastern Mediterranean: Abu Hureyra and ‘Ain Ghazal. In this way, our study enhances knowledge of agricultural practice in the past, adding to understanding of how people have shaped and adapted to their environment over thousands of years

Transfer Matrices and Partition-Function Zeros for Antiferromagnetic Potts Models. V. Further Results for the Square-Lattice Chromatic Polynomial

We derive some new structural results for the transfer matrix of square-lattice Potts models with free and cylindrical boundary conditions. In particular, we obtain explicit closed-form expressions for the dominant (at large |q|) diagonal entry in the transfer matrix, for arbitrary widths m, as the solution of a special one-dimensional polymer model. We also obtain the large-q expansion of the bulk and surface (resp. corner) free energies for the zero-temperature antiferromagnet (= chromatic polynomial) through order q^{-47} (resp. q^{-46}). Finally, we compute chromatic roots for strips of widths 9 <= m <= 12 with free boundary conditions and locate roughly the limiting curves.Comment: 111 pages (LaTeX2e). Includes tex file, three sty files, and 19 Postscript figures. Also included are Mathematica files data_CYL.m and data_FREE.m. Many changes from version 1: new material on series expansions and their analysis, and several proofs of previously conjectured results. Final version to be published in J. Stat. Phy

Spanning forests and the q-state Potts model in the limit q \to 0

We study the q-state Potts model with nearest-neighbor coupling v=e^{\beta J}-1 in the limit q,v \to 0 with the ratio w = v/q held fixed. Combinatorially, this limit gives rise to the generating polynomial of spanning forests; physically, it provides information about the Potts-model phase diagram in the neighborhood of (q,v) = (0,0). We have studied this model on the square and triangular lattices, using a transfer-matrix approach at both real and complex values of w. For both lattices, we have computed the symbolic transfer matrices for cylindrical strips of widths 2 \le L \le 10, as well as the limiting curves of partition-function zeros in the complex w-plane. For real w, we find two distinct phases separated by a transition point w=w_0, where w_0 = -1/4 (resp. w_0 = -0.1753 \pm 0.0002) for the square (resp. triangular) lattice. For w > w_0 we find a non-critical disordered phase, while for w < w_0 our results are compatible with a massless Berker-Kadanoff phase with conformal charge c = -2 and leading thermal scaling dimension x_{T,1} = 2 (marginal operator). At w = w_0 we find a "first-order critical point": the first derivative of the free energy is discontinuous at w_0, while the correlation length diverges as w \downarrow w_0 (and is infinite at w = w_0). The critical behavior at w = w_0 seems to be the same for both lattices and it differs from that of the Berker-Kadanoff phase: our results suggest that the conformal charge is c = -1, the leading thermal scaling dimension is x_{T,1} = 0, and the critical exponents are \nu = 1/d = 1/2 and \alpha = 1.Comment: 131 pages (LaTeX2e). Includes tex file, three sty files, and 65 Postscript figures. Also included are Mathematica files forests_sq_2-9P.m and forests_tri_2-9P.m. Final journal versio

Update on potential medical treatments for encapsulating peritoneal sclerosis; human and experimental data

Encapsulating peritoneal sclerosis (EPS) is an infrequent but serious complication of peritoneal dialysis (PD). The pathogenesis is unknown but speculation is ongoing. The current management of EPS focuses on prevention and treatment of the inflammatory and fibrotic changes at the level of the peritoneal membrane with immunosuppressive and antifibrotic agents, respectively. This article reviews the currently available human and animal data on potential agents to prevent and/or treat EPS. We propose a strategy for early diagnose EPS in an attempt to avoid the development of the full-blown and potentially life-threatening clinical syndrome of EPS. Future research should focus on studying potential prophylactic and therapeutic agents in humans in large, multicenter, randomized trials but also on early detection of EPS in the inflammatory phase by means of biomarkers and the establishment of a composite EPS score