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Federalism and subsidiarity
\"In Federalism and Subsidiarity, a distinguished interdisciplinary group of scholars in political science, law, and philosophy address the application and interaction of the concept of federalism within law and government. What are the best justifications for and conceptions of federalism? What are the most useful criteria for deciding what powers should be allocated to national governments and what powers reserved to state or provincial governments? What are the implications of the principle of subsidiarity for such questions? What should be the constitutional standing of cities in federations? Do we need to \"remap\" federalism to reckon with the emergence of translocal and transnational organizations with porous boundaries that are not reflected in traditional jurisdictional conceptions? Examining these questions and more, this latest installation in the NOMOS series sheds new light on the allocation of power within federations\"-- Provided by publisher.
Book
Federalism and subsidiarity
In Federalism and Subsidiarity, a
distinguished interdisciplinary group of scholars in political science, law,
and philosophy address the application and interaction of the concept of
federalism within law and government. What are the best justifications for and
conceptions of federalism? What are the most useful criteria for deciding what
powers should be allocated to national governments and what powers reserved to
state or provincial governments? What are the implications of the principle of
subsidiarity for such questions? What should be the constitutional standing of
cities in federations? Do we need to \"remap\" federalism to reckon with the
emergence of translocal and transnational organizations with porous boundaries
that are not reflected in traditional jurisdictional conceptions? Examining
these questions and more, this latest installation in the NOMOS series sheds new light on the allocation of power within
federations.
eBook
Individual differences in non-verbal number acuity correlate with maths achievement
Human mathematical competence emerges from two representational systems. Competence in some domains of mathematics, such as calculus, relies on symbolic representations that are unique to humans who have undergone explicit teaching. More basic numerical intuitions are supported by an evolutionarily ancient approximate number system that is shared by adults, infants and non-human animals-these groups can all represent the approximate number of items in visual or auditory arrays without verbally counting, and use this capacity to guide everyday behaviour such as foraging. Despite the widespread nature of the approximate number system both across species and across development, it is not known whether some individuals have a more precise non-verbal 'number sense' than others. Furthermore, the extent to which this system interfaces with the formal, symbolic maths abilities that humans acquire by explicit instruction remains unknown. Here we show that there are large individual differences in the non-verbal approximation abilities of 14-year-old children, and that these individual differences in the present correlate with children's past scores on standardized maths achievement tests, extending all the way back to kindergarten. Moreover, this correlation remains significant when controlling for individual differences in other cognitive and performance factors. Our results show that individual differences in achievement in school mathematics are related to individual differences in the acuity of an evolutionarily ancient, unlearned approximate number sense. Further research will determine whether early differences in number sense acuity affect later maths learning, whether maths education enhances number sense acuity, and the extent to which tertiary factors can affect both.
Journal Article
Master protocols in clinical trials: a universal Swiss Army knife?
Master protocols combine several sub-trials, each with their own research objectives, which is usually presented as one single clinical trial application. Master protocols have become increasingly popular in oncology and haematology, as either basket, umbrella, or platform trials. Although master protocols are intended to accelerate drug development and to reduce futility, their use poses challenges to ethics committees, patients, study investigators, and competent authorities during the review and authorisation process of a clinical trial application. In this Personal View, we review the experiences of clinical trial applications from two European medical regulators—the Danish Medicines Agency and the German Federal Institute for Drugs and Medical Devices. We view master protocols as a good opportunity to identify new treatment options more quickly, particularly for patients with cancer. However, the complexity of trial documentation, the amount of information resulting from sub-trials, and the volume of changes and amendments made to clinical trial applications can cause issues during trial supervision, and during the analysis and review of a corresponding application for marketing authorisation. We draw attention to the potential issues arising from these trial concepts and propose possible solutions to avoid problems during clinical trial authorisation and trial conduct.
Journal Article
Regulation of Medical Devices in the United States and European Union
As compared with Europe, the United States generally requires more rigorous clinical testing of high-risk devices, which delays patients' access to new devices but may provide better assurance of device safety.
Millions of patients worldwide depend on an ever-widening array of medical devices for the diagnosis and management of disease. In the United States, the Food and Drug Administration (FDA) requires manufacturers of high-risk devices such as heart valves and intraocular lens implants to demonstrate safety and effectiveness before the devices can be marketed. However, some policymakers and device manufacturers have characterized U.S. device regulation as slow, risk-averse, and expensive.
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Other experts, such as those at the Institute of Medicine, have suggested that current premarketing procedures may not be comprehensive enough and may be particularly dangerous for devices that have . . .
Journal Article
The Role of the National Competent Authority (NCA) In the Assessment of Medicinal Products in the National Procedure
Assessment is performed by the national competent authority of the country acting as a Reference Member State (RMS) and recognised by the Concerned Member States (CMS), i.e., other countries involved in the authorisation procedure.
Journal Article
Perpetrator Characteristics of Azole Antifungal Drugs on Three Oral Factor Xa Inhibitors Administered as a Microdosed Cocktail
Background
Factor Xa inhibitors (FXaIs) are increasingly used without having sufficient drug–drug interaction data. Using a microdosed cocktail methodology could support filling the knowledge gap quickly.
Methods
In a randomised crossover trial, we investigated the drug–drug interactions between six oral azole antifungals and a microdosed FXaI cocktail containing 25 µg rivaroxaban, 25 µg apixaban, and 50 µg edoxaban. Additionally, different enzyme activities were also monitored using a microdosed cocktail approach. The six different azole antifungals were administered in therapeutic doses over a 24 h period, while the microdosed cocktails were administered 1 h after administration of the azole antifungals.
Results
Ketoconazole and posaconazole were the strongest perpetrators, showing similar increases as apixaban (area under the concentration–time curve ratio [AUCR] 1.64 and 1.62, respectively) and edoxaban (AUCR 2.08 and 2.1, respectively), whereas ketoconazole increased rivaroxaban 2.32-fold but only increased posaconazole 1.37-fold. All other azole antifungals showed less perpetrator effects on the FXaIs. Cytochrome P450 (CYP) 3A inhibition was confirmed using microdosed midazolam, with ketoconazole also the most potent perpetrator (8.42-fold).
Conclusion
Drug–drug interactions for three victim drugs of the same drug class (FXaIs) with different clearance mechanisms can be studied using a microdosed cocktail approach. Using members of the azole antifungal drug class as perpetrators, multiple interactions can be studied in one trial, and a more detailed insight into the underlying interaction mechanisms is possible.
Clinical Trial Registration
EudraCT number: 2017-004453-16.
Journal Article