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Regulatory Issues (regulatory + issues)
Selected AbstractsKetorolac in the Era of Cyclo-Oxygenase-2 Selective Nonsteroidal Anti-Inflammatory Drugs: A Systematic Review of Efficacy, Side Effects, and Regulatory IssuesPAIN MEDICINE, Issue 4 2001Alex Macario MD Objective., The recent introduction of oral COX-2 selective NSAIDs with potential for perioperative use, and the ongoing development of intravenous formulations, stimulated a systemic review of efficacy, side effects, and regulatory issues related to ketorolac for management of postoperative analgesia. Design.,To examine the opioid dose sparing effect of ketorolac, we compiled published, randomized controlled trials of ketorolac versus placebo, with opioids given for breakthrough pain, published in English-language journals from 1986,2001. Odds ratios were computed to assess whether the use of ketorolac reduced the incidence of opioid side effects or improved the quality of analgesia. Results., Depending on the type of surgery, ketorolac reduced opioid dose by a mean of 36% (range 0% to 73%). Seventy percent of patients in control groups experienced moderate-severe pain 1 hour postoperatively, while 36% of the control patients had moderate to severe pain 24 hours postoperatively. Analgesia was improved in patients receiving ketorolac in combination with opioids. However, we did not find a concomitant reduction in opioid side effects (e.g., nausea, vomiting). This may be due to studies having inadequate (to small) sample sizes to detect differences in the incidence of opioid related side effects. The risk for adverse events with ketorolac increases with high doses, with prolonged therapy (>5 days), or invulnerable patients (e.g. the elderly). The incidence of serious adverse events has declined since dosage guidelines were revised. Conclusions., Ketorolac should be administered at the lowest dose necessary. Analgesics that provide effective analgesia with minimal adverse effects are needed. [source] Continuous glucose monitoring and closed-loop systemsDIABETIC MEDICINE, Issue 1 2006R. Hovorka Abstract Background The last two decades have witnessed unprecedented technological progress in the development of continuous glucose sensors, resulting in the first generation of commercial glucose monitors. This has fuelled the development of prototypes of a closed-loop system based on the combination of a continuous monitor, a control algorithm, and an insulin pump. Method A review of electromechanical closed-loop approaches is presented. This is followed by a review of existing prototypes and associated glucose sensors. A literature review was undertaken from 1960 to 2004. Results Two main approaches exist. The extracorporeal s.c.,s.c. approach employs subcutaneous glucose monitoring and subcutaneous insulin delivery. The implantable i.v.,i.p. approach adopts intravenous sampling and intraperitoneal insulin delivery. Feasibility of both solutions has been demonstrated in small-scale laboratory studies using either the classical proportional,integral,derivative controller or a model predictive controller. Performance in the home setting has yet to be demonstrated. Conclusions The glucose monitor remains the main limiting factor in the development of a commercially viable closed-loop system, as presently available monitors fail to demonstrate satisfactory characteristics in terms of reliability and/or accuracy. Regulatory issues are the second limiting factor. Closed-loop systems are likely to be used first by health-care professionals in controlled environments such as intensive care units. [source] Regulatory issues in cellular therapiesJOURNAL OF CELLULAR BIOCHEMISTRY, Issue S38 2002Adrian P. Gee, Article first published online: 23 APR 200 Cellular and gene therapies offer considerable promise as new treatment modalities. The Food and Drug Administration has been developing strategies to regulate these rapidly evolving fields in a manner that sustains progress and also ensures minimization of potential risks. The death of a patient on a gene therapy study highlighted a number of potential problems that have galvanized the agency to examine their strategy and to review current regulations for gene therapy. Meanwhile, a unified regulatory approach is emerging for cell-based therapies. This stratifies the level of regulation based upon the potential risk to the donor of the cells and the recipient. In this article the history and status of regulation of cellular therapy is briefly reviewed. J. Cell. Biochem. Suppl. 38: 104,112, 2002. © 2002 Wiley-Liss, Inc. [source] Identification of optimal poultry litter biorefinery location in Alabama through minimization of feedstock transportation costENVIRONMENTAL PROGRESS & SUSTAINABLE ENERGY, Issue 4 2008Burak Aksoy Abstract The estimated amount of poultry litter produced annually in Alabama is more than 1,250,000 tons. This large amount results in significant litter management challenges. Currently, poultry producers are facing many regulatory issues and challenges with respect to environmental impacts of litter management. Commercialization and implementation of environmentally benign biorefinery technologies have the potential to generate electric power (including on-site power) and heat as well as transportation fuels, hydrogen, valuable chemicals, and fertilizer from poultry litter economically while addressing environmental problems caused by traditional disposal practices. In this study, poultry litter generated annually in northern and southern Alabama was documented on the basis of published literature, and transportation cost of poultry litter is minimized for both north and south Alabama by the selection of the best large-scale biorefining facility location and optimal feedstock allocation using mathematical optimization techniques. The available portion of the existing poultry litter feedstock for a large scale biorefinery is found to be an important factor in determining transportation cost. Transportation cost increases several fold as the local feedstock availability for biorefining reduces from 100 to 50%. Optimum facility locations for both north and south Alabama were found within a 10 mile radius for three different poultry litter feedstock availabilities. © 2008 American Institute of Chemical Engineers Environ Prog, 2008 [source] An overview of the use of quantitative structure-activity relationships for ranking and prioritizing large chemical inventories for environmental risk assessmentsENVIRONMENTAL TOXICOLOGY & CHEMISTRY, Issue 8 2003Christine L. Russom Abstract Ecological risk assessments for chemical stressors are used to establish linkages between likely exposure concentrations and adverse effects to ecological receptors. At times, it is useful to conduct screening risk assessments to assist in prioritizing or ranking chemicals on the basis of potential hazard and exposure assessment parameters. Ranking of large chemical inventories can provide evidence for focusing research and/or cleanup efforts on specific chemicals of concern. Because of financial and time constraints, data gaps exist, and the risk assessor is left with decisions on which models to use to estimate the parameter of concern. In this review, several methods are presented for using quantitative structure-activity relationships (QSARs) in conducting hazard screening or screening-level risk assessments. The ranking methods described include those related to current regulatory issues associated with chemical inventories from Canada, Europe, and the United States and an example of a screening-level risk assessment conducted on chemicals associated with a watershed in the midwest region of the United States. [source] Clinical and experimental uses of umbilical cord bloodINTERNAL MEDICINE JOURNAL, Issue 12 2002I. D. Lewis Abstract Umbilical cord blood (UCB) has been used successfully as an alternative source of haemopoietic stem cells (HSC) in allogeneic stem-cell transplantation for the treatment of acquired and genetic diseases. Advantages of using UCB include: (i) no risk to the donor, (ii) no donor attrition, (iii) minimal risk of viral transmission and (iv) immediate availability. Early results have highlighted differences in engraftment rates and toxicity between UCB and other sources of HSC. These differences relate to the low cell dose in UCB and also to the intrinsic properties of UCB. In this article, the clinical outcome of UCB transplantation (UCBT) will be reviewed with a discussion of the biological characteristics of UCB that may account for some of the clinical outcomes. To overcome the limitations of low cell dose, novel approaches such as ex vivo expansion of HSC are being actively explored, and this will be summarized in the present study. Finally, the success of UCBT has led to the establishment of dedicated UCB banks worldwide and the regulatory issues surrounding this will be briefly discussed. (Intern Med J 2002; 32: 601,609) [source] A DVB/Inmarsat hybrid architecture for asymmetrical broadband mobile satellite servicesINTERNATIONAL JOURNAL OF SATELLITE COMMUNICATIONS AND NETWORKING, Issue 2 2006Bjørn Roger Andersen Abstract In order to bridge the gap, both regulatory and technologically, between offering mobile satellite services at L-band today and broadband mobile services at C-band, Ku-band or Ka-band in the future, a short-term solution is foreseen. Therefore, a DVB/Inmarsat hybrid service offering bi-directional asymmetrical satellite connectivity, with a broadband receive channel at Ku-band based on DVB-S, and with a transmit channel at L-band based on Inmarsat Mobile Packet Data Service, has successfully been developed, implemented and tested. The article focuses on the rationale for, and a technical solution, and how this can be evolved to support use of Inmarsat Broadband Global Area Access as transmit channel at L-band. There are no regulatory issues associated with global operation of such a system, and the users can access the services using cost-efficient off-the-shelf equipment, since the well established Inmarsat and DVB standards are utilized. The system has proved its feasibility to offer services like Internet access, email access, fast file transfers, and IP streaming of audio and video, in addition to the traditional Inmarsat services. Copyright © 2006 John Wiley & Sons, Ltd. [source] Advancing Alcohol Biomarkers ResearchALCOHOLISM, Issue 6 2010Cynthia F. Bearer Biomarkers to detect past alcohol use and identify alcohol-related diseases have long been pursued as important tools for research into alcohol use disorders as well as for clinical and treatment applications and other settings. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) sponsored a workshop titled "Workshop on Biomarkers for Alcohol-Induced Disorders" in June 2008. The intent of this workshop was to review and discuss recent progress in the development and implementation of biomarkers for alcohol use and alcohol-related disorders with a goal to formulate a set of recommendations to use to stimulate and advance research progress in this critical area of alcoholism research. Presentations at this workshop reviewed the current status of alcohol biomarkers, providing a summary of the history of biomarkers and the major goals of alcohol biomarker research. Moreover, presentations provided a comprehensive overview of the current status of several well-recognized biomarkers of alcohol use, a summary of recent studies to characterize novel biomarkers and their validation, along with perspectives and experiences from other NIH institutes and from other federal agencies and industry, related to regulatory issues. Following these presentations, a panel discussion focused on a set of issues presented by the organizers of this workshop. These discussion points addressed: (i) issues related to strategies to be adopted to stimulate biomarker discovery and application, (ii) the relevance of animal studies in biomarker development and the status of biomarkers in basic science studies, and (iii) issues related to the opportunities for clinical and commercial applications. This article summarizes these perspectives and highlights topics that constituted the basis for recommendations to enhance alcohol biomarker research. [source] An Assessment of the Dental Public Health Infrastructure in the United StatesJOURNAL OF PUBLIC HEALTH DENTISTRY, Issue 1 2006Scott L. Tomar DMD Abstract Objectives: The National Institute of Dental and Craniofacial Research commissioned an assessment of the dental public health infrastructure in the United States as a first step toward ensuring its adequacy. This study examined several elements of the US dental public health infrastructure in government, education, workforce, and regulatory issues, focused primarily at the state level. Methods: Data were drawn from a wide range of sources, including original surveys, analysis of existing databases, and compilation of publicly available information. Results: In 2002, 72.5% of states had a full-time dental director and 65% of state dental programs had total budgets of $1 million or less. Among U.S. dental schools, 68% had a dental public health academic unit. Twelve and a half percent of dental schools and 64.3% of dental hygiene programs had no faculty member with a public health degree. Among schools of public health, 15% offered a graduate degree in a dental public health concentration area, and 60% had no faculty member with a dental or dental hygiene degree. There were 141 active diplomates of the American Board of Dental Public Health as of February 2001; 15% worked for state, county, or local governments. In May 2003, there were 640 US members of the American Association of Public Health Dentistry with few members in most states. In 2002, 544 American Dental Association members reported their specialty as Dental Public Health, which ranged from 0 in five states to 41 in California. Just two states had a public health dentist on their dental licensing boards. Conclusions: Findings suggest the US dental public health workforce is small, most state programs have scant funding, the field has minimal presence in academia, and dental public health has little role in the regulation of dentistry and dental hygiene. Successful efforts to enhance the many aspects of the US dental public health infrastructure will require substantial collaboration among many diverse partners. [source] Ketorolac in the Era of Cyclo-Oxygenase-2 Selective Nonsteroidal Anti-Inflammatory Drugs: A Systematic Review of Efficacy, Side Effects, and Regulatory IssuesPAIN MEDICINE, Issue 4 2001Alex Macario MD Objective., The recent introduction of oral COX-2 selective NSAIDs with potential for perioperative use, and the ongoing development of intravenous formulations, stimulated a systemic review of efficacy, side effects, and regulatory issues related to ketorolac for management of postoperative analgesia. Design.,To examine the opioid dose sparing effect of ketorolac, we compiled published, randomized controlled trials of ketorolac versus placebo, with opioids given for breakthrough pain, published in English-language journals from 1986,2001. Odds ratios were computed to assess whether the use of ketorolac reduced the incidence of opioid side effects or improved the quality of analgesia. Results., Depending on the type of surgery, ketorolac reduced opioid dose by a mean of 36% (range 0% to 73%). Seventy percent of patients in control groups experienced moderate-severe pain 1 hour postoperatively, while 36% of the control patients had moderate to severe pain 24 hours postoperatively. Analgesia was improved in patients receiving ketorolac in combination with opioids. However, we did not find a concomitant reduction in opioid side effects (e.g., nausea, vomiting). This may be due to studies having inadequate (to small) sample sizes to detect differences in the incidence of opioid related side effects. The risk for adverse events with ketorolac increases with high doses, with prolonged therapy (>5 days), or invulnerable patients (e.g. the elderly). The incidence of serious adverse events has declined since dosage guidelines were revised. Conclusions., Ketorolac should be administered at the lowest dose necessary. Analgesics that provide effective analgesia with minimal adverse effects are needed. [source] When soft regulation is not enough: The integrated pollution prevention and control directive of the European UnionREGULATION & GOVERNANCE, Issue 3 2010Charalampos Koutalakis Abstract Recent debates regarding the effectiveness of regulatory policymaking in the European Union (EU) focus on the merits of soft, non-binding forms of regulation between public and private actors. The emergence of less coercive forms of regulation is analyzed as a response to powerful functional pressures emanating from the complexity of regulatory issues, as well as the need to secure flexibility and adaptability of regulation to distinctive territorial economic, environmental, administrative, and social conditions. In this article we empirically assess the above normative claims regarding the effectiveness of soft regulation vis-à-vis uniformly binding legislation. We draw on an exploratory investigation of the application of the Integrated Pollution Prevention and Control Directive of the EU in four countries. Our study reveals that effectiveness in the application of soft policy instruments is largely contingent upon strong cognitive, material, and political capacities of both state regulators and industrial actors involved in regulatory policymaking. In the absence of those conditions, the application of soft, legally non-binding regulation may lead to adverse effects, such as non-compliance and the "hollowing out" of the systems of environmental permits to industry. In the medium term, such developments can undermine the normative authority of the EU. [source] PUBLIC SERVICE PERSPECTIVES ON REFORMS OF ELECTRICITY DISTRIBUTION AND SUPPLY: A MODULAR ANALYSISANNALS OF PUBLIC AND COOPERATIVE ECONOMICS, Issue 2 2010Ute Dubois ABSTRACT,:,This article analyzes organizational change in electricity distribution and retail businesses and its impact on public service issues. Organizational change has resulted from the European electricity directives, especially the EU Electricity directive 2003/54/EC, which has imposed major transformations on these activities, requiring legal unbundling of electricity distribution networks by 1 July 2007. Organizational change has also resulted from an adaptation of companies to the newly competitive environment. This has led to a diversity of organizational choices across Europe. We analyze this diversity by using a modular approach, which decomposes reforms in electricity distribution and retail into logical ,blocks'. We then examine how European countries have dealt with two policy and regulatory issues related to customer protection in that new environment: the regulation of quality of distribution, which is a task of regulators, and energy affordability policies for vulnerable customers, which are a central aspect of public service policies in the electricity sector. [source] Control of Pathogenic and Spoilage Microorganisms in Fresh-cut Fruits and Fruit Juices by Traditional and Alternative Natural AntimicrobialsCOMPREHENSIVE REVIEWS IN FOOD SCIENCE AND FOOD SAFETY, Issue 3 2009Rosa M. Raybaudi-Massilia ABSTRACT:, Traditional antimicrobials have been extensively used for many years. However, consumers are currently demanding wholesome, fresh-like, and safe foods without addition of chemically synthesized preservatives. The application of novel natural antimicrobials to assure safety of fresh-cut fruits and unpasteurized juices while preventing quality loss is a promising alternative. The effectiveness of these natural substances added to fruit derivatives has been studied by different researchers. Antimicrobials of animal (lactoperoxidase, lysozyme, and chitosan), plant (essential oils, aldehydes, esters, herbs, and spices), and microbial origin (nisin) can be used to effectively reduce pathogenic and spoilage microorganisms in fresh-cut fruits and fruit juices. Nevertheless, the use of these compounds at a commercial level is still limited due to several factors such as impact on sensory attributes or, in some cases, regulatory issues concerning their use. Therefore, extensive research on the effects of each antimicrobial on food sensory characteristics is still needed so that antimicrobial substances of natural origin can be regarded as feasible alternatives to synthetic ones. [source] | |||||||||||||||||||