Criminal Liability Under the Food, Drug, and Cosmetic Act

The criminal provisions of the Federal Food, Drug, and Cosmetic Act (FDCA)' and the judicial interpretation thereof afford the Food and Drug Administration (FDA) great discretion, in determining both when and against whom criminal prosecution is warranted. Though it may employ a wide variety of enforcement mechanisms, the FDA has relied in recent years ever more heavily on criminal proceedings. Absent appropriate guidelines, however, extensive use of criminal sanctions to enforce the FDCA potentially leads to costly, inefficient, and unnecessary prosecutions. This paper attempts to define such guidelines in the context of criminal liability for corporate officers and employees. First, the paper will describe corporate liability under the FDCA. Next, it will utilize economic tools to propose guidelines to help determine when this liability is best imposed. Finally, it will examine the factual settings of two seminal cases in food and drug law using the proposed guidelines

Religiosity as a demographic factor - an underestimated connection?

Two topics are currently the subject of separate discussions in science and society: the demographic shift and the “return of the religions.“ This article appeals to data from the ALLBUS 1 survey of 2002 to demonstrate that these two phenomena (as well as a number of other questions) can be explained if the connection between religiosity and birth-behavior is taken into account

Islam in Deutschland 2030 - Erstellung einer begründeten Prognose : Seminarbericht, Tübingen, Sommersemester 2006

Wie entwickelt sich der Islam in Deutschland bis 2030? Diese Frage stellte sich unser Seminar der Religionswissenschaft, in dem über 30 Studenten interdisziplinär und auch interkonfessionell zusammenwirkten. Auf der Basis einschlägiger Studien sowie Interviews mit Fachleuten haben wir Zustandsbeschreibungen und Szenarien entwickelt und in einem mehrstufigen Prozess eine gemeinsame Prognose erstellt. Unsere Fragestellung umfasste die Herkunft und Anzahl der Muslime und ihr gesellschaftlicher, wirtschaftlicher und sozialräumlicher Stand, die organisatorischen und rechtlichen Strukturen islamischer Verbände, die Auseinandersetzung zwischen Gemäßigten und Extremisten, das Verhältnis zu Staat, Kirchen und jüdischen Gemeinschaften und auch die allgemeine Entwicklung Deutschlands wie auch der islamischen Welt. Unsere Gesamtprognose fällt vorsichtig optimistisch aus.How will Islam in Germany develop until 2030? This question was tackled by our seminary in comparative religion, to whom more than 30 students from different faculties and denominational backgrounds contributed. Based on corresponding studies as well as interviews with experts, we developped situational descriptions and scenarios and produced by way of a multistage process a shared prognosis. Our question included origin and number of muslims and their societal, economic and sociolocal standing, the organizational and legal structures of islamic associations, the struggle between moderates and extremists, the relationship to the state, churches and jewish communities and also the overall development of Germany as well as of the muslim world. Our overall prognosis culminates to a cautious optimism

Det danser vi om! – Mening med dans og kropslige udtryksformer i børnehaven

Denne artikel undersøger, hvordan arbejdet med dans og kropslige udtryksformer kan blive meningsfuldt i en børnehave, der har børn med forskellige etniske oprindelser og en afdeling for børn med særlige behov. Undersøgelsen baserer sig på empirisk materiale fra LegeKunst-forløbet: Det danser vi om! Her har en professionel danser indenfor modern dance og breakdance inspireret børn og personale til at kaste sig ud i det ukendte og lege og improvisere med kropslige udtryksformer. Mikroanalyser af tre dansescener bruges til både at beskrive rammerne indenfor hvilke improvisation og leg kan blive meningsfuldt og til at beskrive meningsskabende processer, når børn, kunstner og pædagoger danser sammen. Teoretisk tages afsæt i en sociologisk forståelse for meningsfuldhed (Antonovsky, 2000) og en fænomenologisk, kognitionsvidenskabelig tilgang til meningsskabelse (De Jaegher & Di Paolo, 2007; Fuchs & De Jaegher, 2009). Analyserne belyser eksemplarisk, at mening er noget der gøres i fællesskab, og at legende, improviserende tilgange til krop og bevægelse indeholder et stærkt potentiale for meningsskabelse. Afslutningsvis diskuteres, hvordan et sådan eksistentielt orienteret perspektiv kan bidrage med nye forståelser for meningsfulhed i det pædagogiske arbejde i krydsfeltet mellem kunst, leg og pædagogik

Automatic grid construction for few-body quantum mechanical calculations

An algorithm for generating optimal nonuniform grids for solving the two-body Schr\"odinger equation is developed and implemented. The shape of the grid is optimized to accurately reproduce the low-energy part of the spectrum of the Schr\"odinger operator. Grids constructed this way are applicable to more complex few-body systems where the number of grid points is a critical limitation to numerical accuracy. The utility of the grid generation for improving few-body calculations is illustrated through an application to bound states of He trimers

Dermal Delivery of the High-Molecular-Weight Drug Tacrolimus by Means of Polyglycerol-Based Nanogels

Polyglycerol-based thermoresponsive nanogels (tNGs) have been shown to have excellent skin hydration properties and to be valuable delivery systems for sustained release of drugs into skin. In this study, we compared the skin penetration of tacrolimus formulated in tNGs with a commercial 0.1% tacrolimus ointment. The penetration of the drug was investigated in ex vivo abdominal and breast skin, while different methods for skin barrier disruption were investigated to improve skin permeability or simulate inflammatory conditions with compromised skin barrier. The amount of penetrated tacrolimus was measured in skin extracts by liquid chromatography tandem-mass spectrometry (LC-MS/MS), whereas the inflammatory markers IL-6 and IL-8 were detected by enzyme-linked immunosorbent assay (ELISA). Higher amounts of tacrolimus penetrated in breast as compared to abdominal skin or in barrier-disrupted as compared to intact skin, confirming that the stratum corneum is the main barrier for tacrolimus skin penetration. The anti-proliferative effect of the penetrated drug was measured in skin tissue/Jurkat cells co-cultures. Interestingly, tNGs exhibited similar anti-proliferative effects as the 0.1% tacrolimus ointment. We conclude that polyglycerol-based nanogels represent an interesting alternative to paraffin-based formulations for the treatment of inflammatory skin conditions

Improved Multi-Scale Grid Rendering of Point Clouds for Radar Object Detection Networks

Architectures that first convert point clouds to a grid representation and then apply convolutional neural networks achieve good performance for radar-based object detection. However, the transfer from irregular point cloud data to a dense grid structure is often associated with a loss of information, due to the discretization and aggregation of points. In this paper, we propose a novel architecture, multi-scale KPPillarsBEV, that aims to mitigate the negative effects of grid rendering. Specifically, we propose a novel grid rendering method, KPBEV, which leverages the descriptive power of kernel point convolutions to improve the encoding of local point cloud contexts during grid rendering. In addition, we propose a general multi-scale grid rendering formulation to incorporate multi-scale feature maps into convolutional backbones of detection networks with arbitrary grid rendering methods. We perform extensive experiments on the nuScenes dataset and evaluate the methods in terms of detection performance and computational complexity. The proposed multi-scale KPPillarsBEV architecture outperforms the baseline by 5.37% and the previous state of the art by 2.88% in Car AP4.0 (average precision for a matching threshold of 4 meters) on the nuScenes validation set. Moreover, the proposed single-scale KPBEV grid rendering improves the Car AP4.0 by 2.90% over the baseline while maintaining the same inference speed.Comment: (c) 2023 IEEE. Personal use of this material is permitted. Permission from IEEE must be obtained for all other uses, in any current or future media, including reprinting/republishing this material for advertising or promotional purposes, creating new collective works, for resale or redistribution to servers or lists, or reuse of any copyrighted component of this work in other work

Two- versus three-dimensional dual gradient-echo MRI of the liver: a technical comparison

Objective: To compare 2D spoiled dual gradient-echo (SPGR-DE) and 3D SPGR-DE with fat and water separation for the assessment of focal and diffuse fatty infiltration of the liver. Methods: A total of 227 consecutive patients (141 men; 56 ± 14years) underwent clinically indicated liver MRI at 1.5T including multiple-breath-hold 2D SPGR-DE and single-breath-hold 3D SPGR-DE with automatic reconstruction of fat-only images. Two readers assessed the image quality and number of fat-containing liver lesions on 2D and 3D in- and opposed-phase (IP/OP) images. Liver fat content (LFC) was quantified in 138 patients without chronic liver disease from 2D, 3D IP/OP, and 3D fat-only images. Results: Mean durations of 3D and 2D SPGR-DE acquisitions were 23.7 ± 2.9 and 97.2 ± 9.1s respectively. The quality of all 2D and 3D images was rated diagnostically. Three-dimensional SPGR-DE revealed significantly more breathing artefacts resulting in lower image quality (P < 0.001); 2D and 3D IP/OP showed a similar detection rate of fat-containing lesions (P = 0.334) and similar LFC estimations (mean: +0.4%; P = 0.048). LFC estimations based on 3D fat-only images showed significantly higher values (mean: 2.7% + 3.5%) than those from 2D and 3D IP/OP images (P < 0.001). Conclusion: Three dimensional SPGR-DE performs as well as 2D SPGR-DE for the assessment of focal and diffuse fatty infiltration of liver parenchyma. The 3D SPGR-DE sequence used was quicker but more susceptible to breathing artefacts. Significantly higher LFC values are derived from 3D fat-only images than from 2D or 3D IP/OP images. Key Points: • Magnetic resonance imaging can assess focal and diffuse hepatic fatty infiltration • Both 2D and 3D dual-echo MRI techniques can be used for chemical shift imaging of the liver. • The single breath-hold 3D dual-echo technique is faster but more susceptible to breathing artefacts. • Three-dimensional fat-only images show higher fat estimates than in- and out-of-phase image

Improved Orientation Estimation and Detection with Hybrid Object Detection Networks for Automotive Radar

This paper presents novel hybrid architectures that combine grid- and point-based processing to improve the detection performance and orientation estimation of radar-based object detection networks. Purely grid-based detection models operate on a bird's-eye-view (BEV) projection of the input point cloud. These approaches suffer from a loss of detailed information through the discrete grid resolution. This applies in particular to radar object detection, where relatively coarse grid resolutions are commonly used to account for the sparsity of radar point clouds. In contrast, point-based models are not affected by this problem as they process point clouds without discretization. However, they generally exhibit worse detection performances than grid-based methods. We show that a point-based model can extract neighborhood features, leveraging the exact relative positions of points, before grid rendering. This has significant benefits for a subsequent grid-based convolutional detection backbone. In experiments on the public nuScenes dataset our hybrid architecture achieves improvements in terms of detection performance (19.7% higher mAP for car class than next-best radar-only submission) and orientation estimates (11.5% relative orientation improvement) over networks from previous literature.Comment: (c) 2022 IEEE. Personal use of this material is permitted. Permission from IEEE must be obtained for all other uses, in any current or future media, including reprinting/republishing this material for advertising or promotional purposes, creating new collective works, for resale or redistribution to servers or lists, or reuse of any copyrighted component of this work in other work