Bundesinstitut For Arzneimittel Und Medizinprodukte

Bonn, Germany

Bundesinstitut For Arzneimittel Und Medizinprodukte

Bonn, Germany
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Limberg J.,Bundesinstitut For Arzneimittel Und Medizinprodukte
Pharmazeutische Industrie | Year: 2012

This article presents an overview of the current requirements concerning the validation of analytical test procedures for drug products and drug substances. The respective international requirements are introduced and discussed. Further on a definition of the validation parameters is given and recommendations are given how to perform the tests and assess the results. Possible alternatives, actual trends and pragmatic approaches are also introduced. A potential incorporation of the requirements on analytical validation in the quality by design concept introduced in ICH guidelines Q8, Q9 and Q10 is discussed at the end. © ECV • Editio Cantor Verlag.

Lange K.,Heinrich Heine University Düsseldorf | Lange K.,Bundesinstitut For Arzneimittel Und Medizinprodukte | Schnuerch R.,Heinrich Heine University Düsseldorf | 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.

Stingl J.C.,Bundesinstitut For Arzneimittel Und Medizinprodukte | Rotthauwe J.,Bundesinstitut For Arzneimittel Und Medizinprodukte
Deutsche Medizinische Wochenschrift | Year: 2015

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has issued European-wide restrictions on the use of codeine-containing medicines for cough and cold in children at the age of 0-12 because of the risk of serious side effects, including the risk of breathing problems. The PRAC further recommended that codeine must not be used in people of any age who are known to convert codeine into morphine at a faster rate than normal ('ultra-rapid metabolisers'). The reasons for this variability in codeine biotransformation lay in a genetic polymorphism in the liver enzyme CYP2D6 leading to 3 % of the northern European population being ultrarapid metabolisers due to a gene duplication of the enzyme. This is the first restriction of a common drug in CYP2D6 ultrarapid metabolizers, and more use of pharmacogenetic biomarkers for stratified benefit-risk assessment in drug regulation can be expected and will be a first step to Individualized Medicine Regulation. © Georg Thieme Verlag KG Stuttgart New York ISSN 0012-0472.

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.

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.

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.

Agency: European Commission | Branch: FP7 | Program: CSA-CA | Phase: HEALTH-2007-2.1.2-7 | Award Amount: 1.12M | Year: 2009

In contrast to the reductionist approach of Western medicine that is based on modern anatomy, cell and molecular biology, Traditional Chinese Medicine (TCM) uses a unique theory system and an individualised and holistic approach to describe health and disease, based on the philosophy of Yin-Yang balance and an emphasis on harmony of functions. These two medicine systems disagree with each other in many situations as both of them may observe health from their limited perspective. GP-TCM aims to inform best practice and harmonise research of the safety and efficacy of TCM, especially Chinese herbal medicines (CHM) and acupuncture, in EU Member States using a functional genomics approach through exchange of opinions, experience and expertise among scientists in EU Member States and China. In 10 proposed work packages, we will take actions to review the current status, identify problems and solutions in the quality control, extraction and analysis of CHM. While these fundamental issues are addressed, discussion forums emphasising the use of functional genomics methodology in research of the safety, efficacy and mechanisms of CHM and acupuncture will be the core of this Coordination project. It will include the application of the technique in cell-based models, animal models and in clinical studies. Guidelines about good practice and agreed protocols in related research areas will be published to promote future TCM research in all the EU member states; online tools and research resources will be made available to EU member states; EU member states and additional China partners will be invited to join this network; The GP-TCM Research Association will be established during this project and kept running autonomously to continue the guidance and coordination of EU-China collaboration in TCM research.

Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-24-2015 | Award Amount: 14.94M | Year: 2016

Pharmacogenomics is the study of genetic variability affecting an individuals response to a drug. Its use allows personalized medicine and reduction in trial and error prescribing leading to more efficacious, safer and cost-effective drug therapy. The U-PGx consortium will investigate a pre-emptive genotyping approach (that is: multiple pharmacogenomic variants are collected prospectively and embedded into the patients electronic record) of a panel of important pharmacogenomic variants as a new model of personalised medicine. To meet this goal we combine existing pharmacogenomics guidelines and novel health IT solutions. Implementation will be conducted at a large scale in seven existing European health care environments and accounts for the diversity in health system organisations and settings. Feasibility, health outcome and cost-effectiveness will be investigated. We will formulate European strategies for improving clinical implementation of pharmacogenomics based on the findings of this project.

Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.4.2-3 | Award Amount: 2.92M | Year: 2014

The HEALTH.2013.4.2-3 call identifies a need for new or improved statistical methodology for clinical trials for the efficient assessment of safety and/or efficacy of treatment for small population groups. This project brings together international experts in innovative clinical trial design methodology in these specific areas along with key stakeholders including regulatory authorities, industry, clinicians and patient groups to address this need. Our aim is the development novel methodology for the design and analysis of clinical trials in small populations. We will focus on four specific areas where we believe there are particular challenges: (i) early phase dose-finding studies in small populations, (ii) decision-theoretic methods for clinical trials in small populations, (iii) confirmatory trials in small populations and personalised medicines, (iv) use of evidence synthesis in the planning and interpretation of clinical trials in small populations and rare diseases. We will build on recent research advances, of our own and of others in this area. In the rare disease setting, we will focus on Bayesian and decision-theoretic methods that formally enable comparison of the gain in information with the cost, both in economic and opportunity terms, of clinical experimentation, and assess how information from outside the trial can formally be incorporated in the design and decision-making processes. In the personalised medicine setting, we will develop methods that allow evaluation of efficacy in a number of sub-populations simultaneously in a confirmatory clinical trial without any reduction in scientific or statistical rigour.

Agency: European Commission | Branch: FP7 | Program: CSA-SA | Phase: HEALTH.2013.4.1-4 | Award Amount: 645.12K | Year: 2013

The Health Directorate of the European Commissions DG Research and Innovation recently stated that Personalized Medicine is one of the most innovative areas in the future of health research with a high potential for patients, citizens and the economy. However, today the full potential can not be developed due to fragmented activities, insufficient communication and lack of generic solutions in the different areas of Personalized Medicine.The implementation of Personalized Medicine is, therefore, a major challenge in Europe and beyond. It calls for appropriate governance strategies at the European and global level as it challenges the way in which healthcare systems worldwide are set up. Thus, the EC itself, EuroBioForum, the European Health Forum Gastein (EHFG) and others have organized conferences to tackle these challenges. Furthermore, key European organizations and institutions have come up with reports, guidelines, roadmaps aiming to give guidance in this emerging and important health research field amongst others the European Science Foundation (ESF) Forward Look, the Manifesto of the European Alliance for Personalised Medicine (EAPM), the European Best Practice Guidelines of the Public Health Genomics European Network (PHGEN), the Roche report on Personalized Medicine or the report of the European Hospital and Healthcare Federation (HOPE). Based on these initiatives European and national decision-makers and funding bodies not only have expressed the urgent need for a CSA, but also initiated this specific CSA to step up coordination efforts between the European key stakeholders to allow synergies and avoid duplication or competition, to ensure maximum transparency and openness preparing Europe for leading the global way.

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