15 research outputs found

    A critical analysis of disability policy and practice in Flanders : toward differentiated manifestations of interdependency

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    Notions of citizenship and disability rights denote abstract, ambiguous, and contested principles, and realizing these ideas entails complexity in practice. This is particularly the case since the welfare state is no longer conceived as the principal provider of welfare services and resources in many European welfare states. In that vein, we critically analyze the underlying principles, rationales, values, and potential implications of the White Paper "Perspective 2020: a new support policy for disabled people" in Flanders (the Dutch speaking part of Belgium). We tease out which understanding of the disabled human subject is promoted by this so-called innovative social policy and excavate how policy makers and a diversity of actors involved in the policy implementation process consider the provision of care and support. Our main argument entails that the welfare state should acknowledge and vindicate differentiated manifestations of interdependency rather than reinforcing a dichotomy that is based on notions of in/dependent human subjects

    Exploratory clinical development

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    Including the most excluded? A qualitative analysis of the non-take-up of an address for people experiencing homelessness in Belgium

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    In many European countries, one needs a permanent address or domicile to be entitled to social rights. To address this minimum prerequisite, mechanisms for administrative inclusion are in place for people experiencing homelessness without an address, such as the reference address in Belgium. Yet, hitherto, poverty organizations raised concerns whether it succeeds in doing so. This paper disentangles the non-take-up mechanisms behind this reference address by drawing on interviews with professionals. Our evidence suggests this address is a minimum minimorum of social protection, albeit it can reflect and reinforce administrative and social exclusion of the beneficiaries through (1) the disproportionate punitive consequences when not complying to the imposed (sometimes additional) criteria, (2) their subjection to interprofessional (sometimes arbitrary) variation of the administration, and (3) their stigmatization. By focusing on this key policy targeting people experiencing homelessness, the results contribute to the debate on the entitlement to and non-take-up of rights, the barriers that homeless persons are confronted with, and the possibility of an administrative address that includes the most excluded

    Including the most excluded? A qualitative study on the address registration for people experiencing homelessness in Belgium

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    In many European countries, one needs a permanent address or domicile to be entitled to social rights. To address this minimum prerequisite, mechanisms for administrative inclusion are in place for people experiencing homelessness without an address, such as the reference address in Belgium. Yet, hitherto, poverty organizations raised concerns whether it succeeds in doing so. This paper disentangles the non-take-up mechanisms behind this reference address by drawing on interviews with professionals. Our evidence suggests this address is a minimum minimorum of social protection, albeit it can reflect and reinforce administrative and social exclusion of the beneficiaries through (1) the disproportionate punitive consequences when not complying to the imposed (sometimes additional) criteria, (2) their subjection to interprofessional (sometimes arbitrary) variation of the administration, and (3) their stigmatization. By focusing on this key policy targeting people experiencing homelessness, the results contribute to the debate on the entitlement to and non-take-up of rights, the barriers that homeless persons are confronted with, and the possibility of an administrative address that includes the most excluded

    Researching the Non-Take up of social rights: a social work perspective

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    In the face of growing social, economic, political and demographic challenges, many European welfare states have been confronted with barriers in realising the social rights of certain groups of citizens. This phenomenon has often been referred to as ‘the non-take up of social rights’. Considering the core mandate and key principles of social work as a practice-based profession and academic discipline, we argue that social work should have a key role in knowledge and practice development on understanding and combating the non-take up of social rights. Our integrative contextual literature review, nonetheless, demonstrates that there is a tangible scarcity of theoretically and empirically grounded social work research that generates fruitful and indepth insights into the socially unjust situations and complex dynamics behind these processes of non-take up. This article therefore aims to identify and discuss the key knowledge gaps in the existing body of research on non-take up. As a result, we address critical foci for a future empirical social work research agenda to munition social work practice development that strongly accentuates the substantial realisation of social rights and accordingly contributes to social justice

    Switchability of gabapentin formulations : a randomized trial to assess bioequivalence between Neurontin and Gabasandoz on the individual subject level

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    Generic substitution of antiepileptic drugs is generally not advised by neurologists. The present study investigated the switchability of gabapentin 800 mg tablets (Neurontin and Gabasandoz) using an individual bioequivalence (IBE) study design with two batches of each product and assessed whether between-batch and between-formulation variability in exposure play a significant role in the within-subject variability. The trial was analyzed according to the US Food and Drug Administration (FDA) framework to establish IBE. The IBE was shown between both products with the 95% upper confidence bound of the IBE criterion being -2.01 and -2.31 for area under the concentration-time curve from zero to infinity (AUC(0-inf)) and peak plasma concentration (C-max), respectively. Subject-by-formulation variability (1.35%) was negligible compared with the within-subject variability of AUC(0-inf) with Neurontin (19.0%) and Gabasandoz (23.6%). Inclusion of an additional batch did not significantly change this within-subject variability (20.2% and 23.6%, respectively). This study shows that substitution of gabapentin 800 mg tablets of Neurontin and Gabasandoz should be possible without affecting clinical outcomes

    Doravirine and the potential for CYP3A-mediated drug-drug interactions

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    Identifying and understanding potential drug-drug interactions (DDIs) are vital for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This article discusses DDIs between doravirine, a nonnucleoside reverse transcriptase inhibitor (NNRTI), and cytochrome P450 3A (CYP3A) substrates and drugs that modulate CYP3A activity. Consistent with previously published in vitro data and DDI trials with the CYP3A substrates midazolam and atorvastatin, doravirine did not have any meaningful impact on the pharmacokinetics of the CYP3A substrates ethinyl estradiol and levonorgestrel. Coadministration of doravirine with CYP3A inhibitors (ritonavir or ketoconazole) increased doravirine exposure approximately 3-fold. However, these increases were not considered clinically meaningful. Conversely, previously published trials showed that coadministered CYP3A inducers (rifampin and rifabutin) decreased doravirine exposure by 88% and 50%, respectively (K. L. Yee, S. G. Khalilieh, R. I. Sanchez, R. Liu, et al., Clin Drug Investig 37: 659-667, 2017 [https://doi. org/10.1007/s40261-017-0513-4]; S. G. Khalilieh, K. L. Yee, R. I. Sanchez, R. Liu, et al., J Clin Pharmacol 58: 1044-1052, 2018 [https://doi.org/10.1002/jcph.1103]), while doravirine exposure following prior efavirenz administration led to an initial reduction in doravirine exposure of 62%, but the reduction became less pronounced with time (K. L. Yee, R. I. Sanchez, P. Auger, R. Liu, et al., Antimicrob Agents Chemother 61: e01757-16, 2017 [https://doi.org/10.1128/AAC.01757-16]). Overall, the coadministration of doravirine with CYP3A inhibitors and substrates is, therefore, supported by these data together with efficacy and safety data from clinical trials, while coadministration with strong CYP3A inducers, such as rifampin, cannot be recommended. Concomitant dosing with rifabutin (a CYP3A inducer less potent than rifampin) is acceptable if doravirine dosing is adjusted from once to twice daily; however, the effect of other moderate inducers on doravirine pharmacokinetics is unknown

    Additional file 4: Figure S2. of KH176 under development for rare mitochondrial disease: a first in man randomized controlled clinical trial in healthy male volunteers

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    Posthoc ECG assessment results. A. Change in QTcF (median increase from baseline; SAD study). B. Change in TpTe (median increase from baseline; SAD study). C. Change in the T-wave symmetry index (median increase from baseline; SAD study). D. Change in QTcF (median increase from baseline; SAD study). E. Change in TpTe (median increase from baseline; MAD study). F. Change in the T-wave symmetry index (median increase from baseline; MAD study). (PDF 341 kb
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