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Regulatory Aspects (regulatory + aspect)
Selected AbstractsOverview of the DVB-SH specificationsINTERNATIONAL JOURNAL OF SATELLITE COMMUNICATIONS AND NETWORKING, Issue 4-5 2009Philip Kelley Abstract This article provides an overview of the DVB-SH specifications, and the context within which they have been developed. The main DVB-SH configurations are introduced, with explanations of both the technical and frequency planning considerations that drive choices. Regulatory aspects in the European Union and United States of America are summarized. Then specific DVB-SH issues are being addressed, involving reception conditions and channel characteristics, combining techniques for satellite and terrestrial signals, and synchronization and local content insertion. Some attention is paid to the reuse of DVB link and application layer features. Finally, a couple of likely service introduction scenarios are suggested. It is claimed that DVB-SH fulfills the initial requirements of extending the present UHF-based service offer to other frequencies below 3,GHz with a large area coverage, a reduced total network infrastructure cost and an expansion of the offer in terms of number of TV channels or multimedia services. Copyright © 2009 John Wiley & Sons, Ltd. [source] Galacto-Oligosaccharides: Production, Properties, Applications, and Significance as PrebioticsCOMPREHENSIVE REVIEWS IN FOOD SCIENCE AND FOOD SAFETY, Issue 5 2010Duarte P.M. Torres Currently, GOS are produced by glycoside hydrolases (GH) using lactose as substrate. Converting lactose into GOS by GH results in mixtures containing GOS of different degrees of polymerization (DP), unreacted lactose, and monomeric sugars (glucose and galactose). Recent and future developments in the production of GOS aim at delivering purer and more efficient mixtures. To produce high-GOS-content mixtures, GH should not only have good ability to catalyze the transgalactosylation reaction relative to hydrolysis, but also have low affinity for the GOS formed relative to the affinity for lactose. In this article, several microbial GH, proposed for the synthesis of GOS, are hierarchized according to the referred performance indicators. In addition, strategies for process improvement are discussed. Besides the differences in purity of GOS mixtures, differences in the position of the glycosidic linkages occur, because different enzymes have different regiochemical selectivity. Depending on oligosaccharide composition, GOS products will vary in terms of prebiotic activity, as well as other physiological effects. This review focuses on GOS production from synthesis to purification processes. Physicochemical characteristics, physiological effects, and applications of these prebiotic ingredients are summarized. Regulatory aspects of GOS-containing food products are also highlighted with emphasis on the current process of health claims evaluation in Europe. [source] SYMPOSIUM REVIEW: Lipid microdomains and the regulation of ion channel functionTHE JOURNAL OF PHYSIOLOGY, Issue 17 2010Caroline Dart Many types of ion channel localize to cholesterol and sphingolipid-enriched regions of the plasma membrane known as lipid microdomains or ,rafts'. The precise physiological role of these unique lipid microenvironments remains elusive due largely to difficulties associated with studying these potentially extremely small and dynamic domains. Nevertheless, increasing evidence suggests that membrane rafts regulate channel function in a number of different ways. Raft-enriched lipids such as cholesterol and sphingolipids exert effects on channel activity either through direct protein,lipid interactions or by influencing the physical properties of the bilayer. Rafts also appear to selectively recruit interacting signalling molecules to generate subcellular compartments that may be important for efficient and selective signal transduction. Direct interaction with raft-associated scaffold proteins such as caveolin can also influence channel function by altering gating kinetics or by affecting trafficking and surface expression. Selective association of ion channels with specific lipid microenvironments within the membrane is thus likely to be an important and fundamental regulatory aspect of channel physiology. This brief review highlights some of the existing evidence for raft modulation of channel function. [source] A critical reappraisal of treatment response criteria in systemic mastocytosis and a proposal for revisionsEUROPEAN JOURNAL OF HAEMATOLOGY, Issue 5 2010A. Pardanani Abstract Mast cell disease (MCD) is a hematopoietic stem cell neoplasm that is associated with infiltration of one or more organs with cytologically abnormal mast cells (MC). MCD is frequently but not always associated with a KIT mutation and, in some cases, is associated with clonal expansion of non-MC lineage cells. In adults, there is almost always MC infiltration of the bone marrow, which is a cardinal feature of systemic mastocytosis (SM). While, as members of the wider community of physician scientists, we recognize the contribution of the current consensus treatment response criteria for SM, as individuals with more than average clinical experience in SM, we would like to point out their limitations and engage in a constructive discussion that will hopefully lead to a consideration for revisions. We present here an alternative proposal for treatment response assessments we believe is more objective, reproducible, and importantly, SM-subtype specific, given the recent progress in our understanding of the natural history of this disease. We believe this proposal is timely given the prospects for new clinical trials in SM, and the related regulatory aspects of new drug approval that are currently not adequately addressed. The intent of this exercise is not to undermine the complexity of the disease or previous work by other investigators, but to come up with ideas for response criteria that are more practical and consider meaningful patient outcome. [source] Commentary: Mining for nutrients , regulatory aspects of cluster root function and developmentNEW PHYTOLOGIST, Issue 4 2010Günter Neumann First page of article [source] Organizational context and taxonomy of health care databasesPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 5 2001Deborah Shatin PhD Abstract An understanding of the organizational context and taxonomy of health care databases is essential to appropriately use these data sources for research purposes. Characteristics of the organizational structure of the specific health care setting, including the model type, financial arrangement, and provider access, have implications for accessing and using this data effectively. Additionally, the benefit coverage environment may affect the utility of health care databases to address specific research questions. Coverage considerations that affect pharmacoepidemiologic research include eligibility, the nature of the pharmacy benefit, and regulatory aspects of the treatment under consideration. Copyright © 2001 John Wiley & Sons, Ltd. [source] The journey of Indian GLP programme,looking back and forwardQUALITY ASSURANCE JOURNAL, Issue 1 2009V. Amalan Stanley Abstract The Indian GLP (Good Laboratory Practice) compliance monitoring programme has successfully brought the task of implementing the programme to the foreground where full OECD (Organization for Economic Cooperation and Development) membership is about to happen. It has been a long journey, more than five years for the programme to arrive at this juncture, succeeding through sheer commitment and will of the Science and Technology initiatives under which the programme has been implemented. Considering the spontaneous and natural challenges that are bound to make the effort of implementing the GLP compliance programme tougher for any country, the progress made by the Indian GLP programme can be considered very rapid. Though the dawn of full OECD membership for the Indian GLP programme is imminent the paper deals with the details of the journey it has traveled so far and the challenges ahead, commending the commitment of the efforts of the GLP MA (Monitoring Authority) as well as the preparedness of the test facilities. This paper discusses the GLP policy aspects that favoured the growth of the programme among non-member adherents, such as the allowance for getting GLP certification by GLP MA abroad. It also deals with the challenge of harmonizing the policies of the internal agencies that have direct influence on the implementation of the GLP programme, other than legalizing the GLP aspects as there are various government departments in India dealing with the regulatory aspects of specific drug products for human use or that are of chemical in origin. There are data requirements made mandatory by these institutions on pre-clinical or non-clinical safety evaluation of those products, which invariably necessitate studies conducted in compliance with the principles of GLP. The paper concludes with the emphasis that there is a primary need for harmony as well as legal or judicial underpinnings under the umbrella of a national GLP Monitoring Authority, a gray area to be essentially tackled with foresight, to earn credibility on the international front. Copyright © 2009 John Wiley & Sons, Ltd. [source] Molecular facets of sphingolipids: Mediators of diseasesBIOTECHNOLOGY JOURNAL, Issue 7 2009Fatma Betul Kavun Ozbayraktar Abstract Sphingolipids constitute a biologically active lipid class that is significantly important from both structural and regulatory aspects. The manipulation of sphingolipid metabolism is currently being studied as a novel strategy for cancer therapy. The basics of this therapeutic approach lie in the regulation property of sphingolipids on cellular processes, which are important in a cell's fate, such as cell proliferation, apoptosis, cell cycle arrest, senescence, and inflammation. Furthermore, the mutations in the enzymes catalyzing some specific reactions in the sphingolipid metabolism cause mortal lysosomal storage diseases like Fabry, Gaucher, Niemann-Pick, Farber, Krabbe, and Metachromatic Leukodystrophy. Therefore, the alteration of the sphingolipid metabolic pathway determines the choice between life and death. Understanding the sphingolipid metabolism and regulation is significant for the development of new therapeutic approaches for all sphingolipid-related diseases, as well as for cancer. An important feature of the sphingolipid metabolic pathway is the compartmentalization into endoplasmic reticulum, the Golgi apparatus, lysosome and plasma membrane, and this compartmentalization makes the transport of sphingolipids critical for proper functioning. This paper focuses on the structures, metabolic pathways, localization, transport mechanisms, and diseases of sphingolipids in Saccharomyces cerevisiae and humans, and provides the latest comprehensive information on sphingolipid research. [source] Emotion and Evolving Treatments for Adult PsychopathologyCLINICAL PSYCHOLOGY: SCIENCE AND PRACTICE, Issue 4 2007Douglas Mennin Clinical psychology has historically underplayed the importance of emotions in conceptualizing and treating adult psychopathology. However, there has been a recent convergence among numerous theoretical orientations in drawing from investigations of emotions within basic affective sciences, which highlight the survival and societal functions of emotions, the involvement of multiple biological systems in emotion generation, and a dynamic model for regulatory aspects of emotions. These characterizations of emotion suggest a number of ways that current treatments may benefit from explicit incorporation of interventions targeting emotions, particularly for resistant forms of adult psychopathology. Specifically, emotion-related skills training and broadening the role of emotions in meaning change may be important areas for expansion within the treatment of adult psychopathology. [source] | |||||||||||||