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Lange K.,Heinrich Heine University Dusseldorf | Lange K.,Bundesinstitut For Arzneimittel Und Medizinprodukte | Schnuerch R.,Heinrich Heine University Dusseldorf | Schnuerch R.,University of Bonn
Brain and Cognition | Year: 2014

Both filter and resource models of attention suggest an influence of task difficulty on the size of early attention effects. As for temporal orienting, the idea that early effects are modulated by task difficulty has not been tested directly, so far. To fill this empirical gap, the present study used an auditory temporal-orienting task, in which two differently pitched pure tones served as targets. To manipulate perceptual difficulty, the pitch difference between the targets was either small or large. Temporal orienting enhanced the N1 component of the auditory event-related potential. This early, sensory effect tended to be larger in the more difficult condition, particularly over the frontal scalp. Notably, increasing task difficulty affected predominantly the processing of attended stimuli. Hence, temporal orienting may operate by increasing processing resources or gain settings for the attended time point - rather than by withdrawing resources from the unattended time point. © 2013. Source

Haas M.,European Medicines Agency | Mantua V.,Agenzia Italiana del Farmaco | Haberkamp M.,Bundesinstitut For Arzneimittel Und Medizinprodukte | Pani L.,Agenzia Italiana del Farmaco | And 4 more authors.
Nature Reviews Drug Discovery | Year: 2015

Regulatory agencies have a key role in facilitating the development of new drugs for Alzheimer disease, particularly given the challenges associated with early intervention. Here, we highlight the strategies of the European Medicines Agency to help address such challenges. © 2015 Macmillan Publishers Limited. Source

Marzoll A.,Bundesinstitut For Arzneimittel Und Medizinprodukte | Melchior-Becker A.,University of Duisburg - Essen | Cipollone F.,University of Chieti Pescara | Fischer J.W.,University of Duisburg - Essen
Journal of Cellular and Molecular Medicine | Year: 2011

Small leucine-rich proteoglycans (SLRPs), such as decorin and biglycan, regulate the assembly and turnover of collagenous matrix. The aim of the study was to analyse the effect of chronic rosuvastatin treatment on decorin, biglycan and the collagen matrix in ApoE-deficient mice. Twenty-week-old male ApoE-deficient mice received normal chow or 20 mg rosuvastatin/kg × day for 32 weeks. Subsequently, matrix composition was analysed by histochemistry and immunostaining at the aortic root and in innominate arteries of ApoE deficient mice as well as in human carotid endarterectomy specimens. Immunoblotting of proteoglycans was performed from aortic extracts of ApoE-deficient mice. Immunohistochemistry and immunoblotting revealed strongly increased decorin and biglycan deposition in atherosclerotic plaques at the aortic root and in innominate arteries. In contrast, versican and perlecan expression was not changed by rosu-vastatin. Furthermore, matrix metalloproteinase 2 and gelatinolytic activity were decreased in response to rosuvastatin and a condensed collagen-rich matrix was formed. In carotid endarterectomy specimens of statin-treated patients increased decorin and biglycan accumulation was detected as well. Drug treatment did not change low-density lipoprotein (LDL) plasma levels in ApoE-deficient mice and did not significantly affect lipid retention at the aortic root level as demonstrated by oil-red O staining and immunohistochemistry of LDL. Long-term treatment with rosuvastatin caused pronounced remodelling of atherosclerotic plaque matrix characterized specifically by enrichment with SLRPs and formation of a condensed collagen matrix. Therefore, decorin and biglycan might represent novel targets of statin treatment that contribute to a stable plaque phenotype. © 2011 The Authors Journal of Cellular and Molecular Medicine © 2011 Foundation for Cellular and Molecular Medicine/Blackwell Publishing Ltd. Source

Bieber T.,Universitats Klinikum Bonn | Broich K.,Bundesinstitut For Arzneimittel Und Medizinprodukte
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz | Year: 2013

Personalised medicine will address the clinical and pathophysiologic complexity of many diseases with the aim of developing therapeutic strategies more adapted for selected individuals or patient subgroups in order to improve efficacy and safety of medicinal products. This biomarker-based approach will potentially allow identification of populations at risk for chronic and life-threatening diseases and to design early intervention strategies. Personalised medicine will lead to a substantial move from costly and often inefficient health care to a hopefully more cost effective, more targeted and more preventive approach addressing participative patients with increased health literacy. Thus, it provides the basement for an ultimate paradigm shift of modern medicine, away from a "reactive" medicine to a more "proactive" and personalised health care, so-called "P4 medicine". © 2013 Springer-Verlag Berlin Heidelberg. Source

Knoss W.,Bundesinstitut For Arzneimittel Und Medizinprodukte
Zeitschrift fur Phytotherapie | Year: 2010

The legal framework for marketing authorisation or registration of herbal medicinal products or traditional herbal medicinal products is clearly defined. The particular regulatory requirements depend on the specific procedure. The assessment of quality, efficacy and safety of herbal medicinal products which are also intended to be used to treat children and adolescents should take into account the particularities with respect to diagnosis and self-medication. Scientific data on herbal medicinal products for children are limited and initiatives should be started to generate data to assure a reasonable choice of herbal medicinal products for children. Source

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