146 research outputs found

    The Personal is Political:Pentecostal Approaches to Governance and Security

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    In this essay, I explore Pentecostal approaches to governance and security, taking an anthropological approach. I focus on Pentecostalism as a distinctive way of looking at and being in the world, one that understands the family as central in its approach governance and security. I highlight the paradox between Pentecostalism’s strong orientation towards individual and family moral conduct and practices of female leadership in Pentecostal contexts. I conclude with some broader reflections on the implications for diplomacy and other practitioners of foreign policy

    ‘You can’t just be a Muslim in outer space’:young people making sense of religion at local places in the city

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    This paper demonstrates how young people make sense of religion through local places in the urban context while moving from youth to young adulthood. We draw on in-depth interviews–including a mental map-making exercise–with twenty-four young Muslims (18–30) from a wide range of cultural backgrounds living in Metro Vancouver (Canada). Their narratives reveal young people ‘live’ religion in various local places and how spatialities of lived religion change over time. We highlight how making sense of religion is reflected in the changing meaning of the mosque and relates to the increased salience of places shared with young Muslims in which our participants negotiate religion in the context of their everyday lives in the city. While many studies on Muslim identities have established the complexities and dynamics of negotiating religion at specific local places, we argue for a focus on relations between lived religion at various local places over time. These spatiotemporal complexities are able to capture how making sense of religion is spatially and fluidly manifested in the urban context of Metro Vancouver

    Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics

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    Adopted guidelines reflect a harmonised European approach to a specific scientific issue and should reflect the most recent scientific knowledge. However, whilst EU regulations are mandatory for all member states and EU directives must be followed by national laws in line with the directive, EMA guidelines do not have legal force and alternative approaches may be taken, but these obviously require more justification. This new series of the BJCP, developed in collaboration with the EMA, aims to address this issue by providing an annotated version of some relevant EMA guidelines and regulatory documents by experts. Hopefully, this will help in promoting their diffusion and in opening a forum for discussion with our readers.Pharmacolog

    The role of population PK-PD modelling in paediatric clinical research

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    Children differ from adults in their response to drugs. While this may be the result of changes in dose exposure (pharmacokinetics [PK]) and/or exposure response (pharmacodynamics [PD]) relationships, the magnitude of these changes may not be solely reflected by differences in body weight. As a consequence, dosing recommendations empirically derived from adults dosing regimens using linear extrapolations based on body weight, can result in therapeutic failure, occurrence of adverse effect or even fatalities. In order to define rational, patient-tailored dosing schemes, population PK-PD studies in children are needed. For the analysis of the data, population modelling using non-linear mixed effect modelling is the preferred tool since this approach allows for the analysis of sparse and unbalanced datasets. Additionally, it permits the exploration of the influence of different covariates such as body weight and age to explain the variability in drug response. Finally, using this approach, these PK-PD studies can be designed in the most efficient manner in order to obtain the maximum information on the PK-PD parameters with the highest precision. Once a population PK-PD model is developed, internal and external validations should be performed. If the model performs well in these validation procedures, model simulations can be used to define a dosing regimen, which in turn needs to be tested and challenged in a prospective clinical trial. This methodology will improve the efficacy/safety balance of dosing guidelines, which will be of benefit to the individual child

    Systematic Evaluation of the Descriptive and Predictive Performance of Paediatric Morphine Population Models

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    Purpose: A framework for the evaluation of paediatric population models is proposed and applied to two different paediatric population pharmacokinetic models for morphine. One covariate model was based on a systematic covariate analysis, the other on fixed allometric scaling principles. Methods: The six evaluation criteria in the framework were 1) number of parameters and condition number, 2) numerical diagnostics, 3) prediction-based diagnostics, 4) η-shrinkage, 5) simulation-based diagnostics, 6) diagnostics of individual and population parameter estimates versus covariates, including measurements of bias and precision of the population values compared to the observed individual values. The framework entails both an internal and external model evaluation procedure. Results: The application of the framework to the two models resulted in the detection of overparameterization and misleading diagnostics based on individual predictions caused by high shrinkage. The diagnostic of individual and population parameter estimates versus covariates proved to be highly informative in assessing obtained covariate relationships. Based on the framework, the systematic covariate model proved to be superior over the fixed allometric model in terms of predictive performance. Conclusions: The proposed framework is suitable for the evaluation of paediatric (covariate) models and should be applied to corroborate the descriptive and predictive properties of these models

    Thermal diffusivity and Biot number: a new experimental method

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    A new simple method is presented for measuring thermal diffusivity and Biot number in cylindrical samples made of relatively highly conducting materials, subjected to laminar air flow. The basic idea is a heat source in the middle section of the sample, acting also as a thermocouple; only one additional temperature sensor at the cylinder basis is required to give all information, without requiring any hypothesis about the effective time dependence of the heat source

    Gender differences and gender convergence in alcohol use over the past three decades (1984–2008), The HUNT Study, Norway

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    Abstract Background To examine changes in men‘s and women’s drinking in Norway over a 20-year period, in order to learn whether such changes have led to gender convergence in alcohol drinking. Methods Repeated cross-sectional studies (in 1984–86, 1995–97, and 2006–08) of a large general population living in a geographically defined area (county) in Norway. Information about alcohol drinking is based on self-report questionnaires. Not all measures were assessed in all three surveys. Results Adult alcohol drinking patterns have changed markedly over a 20-year period. Abstaining has become rarer while consumption and rates of recent drinking and problematic drinking have increased. Most changes were in the same direction for men and women, but women have moved towards men’s drinking patterns in abstaining, recent drinking, problematic drinking and consumption. Intoxication (among recent drinkers) has decreased in both genders, but more in men than in women. The declines in gender differences, however, were age-specific and varied depending on which drinking behavior and which beverage was taken into account. Conclusions There has been a gender convergence in most drinking behaviours, including lifetime history of problem drinking, over the past 2–3 decades in this Norwegian general population, but the reasons for this convergence appear to be complex

    Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance.

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    Pharmacokinetic/pharmacodynamic (PKPD) modeling is important in the design and conduct of clinical pharmacology research in children. During drug development, PKPD modeling and simulation should underpin rational trial design and facilitate extrapolation to investigate efficacy and safety. The application of PKPD modeling to optimize dosing recommendations and therapeutic drug monitoring is also increasing, and PKPD model-based dose individualization will become a core feature of personalized medicine. Following extensive progress on pediatric PK modeling, a greater emphasis now needs to be placed on PD modeling to understand age-related changes in drug effects. This paper discusses the principles of PKPD modeling in the context of pediatric drug development, summarizing how important PK parameters, such as clearance (CL), are scaled with size and age, and highlights a standardized method for CL scaling in children. One standard scaling method would facilitate comparison of PK parameters across multiple studies, thus increasing the utility of existing PK models and facilitating optimal design of new studies
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