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Benefit Assessments (benefit + assessment)
Selected AbstractsBenefit assessment of therapeutic products: the Centers for Education and Research on Therapeutics,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 1 2007Robert M. Califf MD Abstract The ability to manage risk depends critically on an understanding of the degree to which a known risk is balanced by the probability of a clinical benefit. Despite the massive emphasis on risk and risk management in the past few years and the long-term focus on defining benefit in the regulatory system, considerable uncertainty remains about the methods of defining benefit and how to operationalize this knowledge. In this ,think tank,' part of a larger series on risk management, issues were divided into those that can be identified before a study is initiated, those that commonly arise after a study is completed, biomarkers and surrogates, use of benefit findings in defining quality and performance indicators, implementation of findings into health systems and formularies, and methods of comparative trials. Key categories for the establishment of a research agenda to fill in gaps in our understanding of assessing benefit were developed by the group. Copyright © 2006 John Wiley & Sons, Ltd. [source] Biosimilars: pharmacovigilance and risk management,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2010Leyre Zuñiga Ph.D. Abstract Biosimilars cannot be authorised based on the same requirements that apply to generic medicines. Despite the fact that the biosimilar and reference drug can show similar efficacy, the biosimilar may exhibit different safety profile in terms of nature, seriousness or incidence of adverse reactions. However, the data from pre-authorisation clinical studies normally are insufficient to identify all potential differences. Therefore, clinical safety of similar biological medicinal products must be monitored closely on an ongoing basis during the post-approval phase including continued risk,benefit assessment. The biosimilar applicant must provide the European Medicines Agency (EMEA) with a risk management plan (EU-RMP) and pharmacovigilance programme with its application, including a description of the potential safety issues associated with the similar biological medicinal product that may be a result of differences in the manufacturing process from the reference biologic. The most critical safety concern relating to biopharmaceuticals (including biosimilars) is immunogenicity. Risk management applies scientifically based methodologies to identify, assess, communicate and minimise risk throughout a drug's life cycle so as to establish and maintain a favourable benefit,risk profile in patients. The risk management plan for biosimilars should focus on heightens the pharmacovigilance measures, identify immunogenicity risk and implement special post-marketing surveillance. Although International Nonproprietary Names (INNs) served as a useful tool in worldwide pharmacovigilance, for biologicals they should not be relied upon as the only means of product identification. Biologicals should always be commercialised with a brand name or the INN plus the manufacturer's name. Copyright © 2010 John Wiley & Sons, Ltd. [source] Evaluation of Needle Exchange ProgramsPUBLIC HEALTH NURSING, Issue 2 2004Cheryl Delgado M.S.N. Abstract Needle exchange programs exist in every major population area in the United States and in many other countries. Some operate legally under emergency health decrees issued by local departments of health, with the stated intention of risk reduction through the removal of used injection equipment from use by injection drug users. It is theorized that this results in a reduced transmission of human immunodeficiency virus, hepatitis, and, possibly, other blood-borne diseases. Needle exchange programs also offer access to drug treatment programs for the participants. It is a difficult but necessary task to evaluate these programs. This article examines examples of evaluations attempted in the past and discusses the challenges of such evaluations. Experimental evaluations, economic program analysis, legal aspects, and risk,benefit assessment along with ethical aspects are considered. An outline of program evaluation is proposed. Needle exchange programs offer an opportunity to encourage risk reduction and to offer counseling and access to health care for individuals at high risk. It is essential that such programs demonstrate their effectiveness. Assumptions of efficacy are insufficient for health care in the twenty-first century. [source] Solar UV Geometric Conversion Factors: Horizontal Plane to Cylinder Model,PHOTOCHEMISTRY & PHOTOBIOLOGY, Issue 2 2010Stanley J. Pope Most solar UV measurements are relative to the horizontal plane. However, problems arise when one uses those UV measurements to perform risk or benefit assessments because they do not yield the actual doses people get while they are outdoors. To better estimate the UV doses people actually get while outdoors, scientists need geometric conversion factors (GCF) that change horizontal plane irradiances to average irradiances on the human body. Here we describe a simple geometric method that changes unweighted, erythemally weighted and previtamin D3 -weighted UV irradiances on the horizontal plane to full cylinder and semicylinder irradiances. Scientists can use the full cylinder model to represent the complete human body, while they can use the semicylinder model to represent the face, shoulders, tops of hands and feet. We present daily, monthly and seasonally calculated averages of the GCF for these cylinder models every 5° from 20 to 70°N so that scientists can now get realistic UV doses for people who are outdoors doing a variety of different activities. The GCF show that people actually get less than half their annual erythemally weighted, and consequently half their previtamin D3 -weighted, UV doses relative to the horizontal plane. Thus, scientists can now perform realistic UV risk and benefit assessments. [source] Action Spectrum Conversion Factors that Change Erythemally Weighted to Previtamin D3 -weighted UV Doses,PHOTOCHEMISTRY & PHOTOBIOLOGY, Issue 5 2008Stanley J. Pope Many solar UV measurements, either terrestrial or personal, weight the raw data by the erythemal action spectrum. However, a problem arises when one tries to estimate the benefit of vitamin D3 production based on erythemally weighted outdoor doses, like those measured by calibrated R-B meters or polysulphone badges, because the differences between action spectra give dissimilar values. While both action spectra peak in the UVB region, the erythemal action spectrum continues throughout the UVA region while the previtamin D3 action spectrum stops near that boundary. When one uses the previtamin D3 action spectrum to weight the solar spectra (Deff), one gets a different contribution in W m,2 than what the erythemally weighted data predicts (Eeff). Thus, to do proper benefit assessments, one must incorporate action spectrum conversion factors (ASCF) into the calculations to change erythemally weighted to previtamin D3 -weighted doses. To date, all benefit assessments for vitamin D3 production in human skin from outdoor exposures are overestimates because they did not account for the different contributions of each action spectrum with changing solar zenith angle and ozone and they did not account for body geometry. Here we describe how to normalize the ratios of the effective irradiances (Deff/Eeff) to get ASCF that change erythemally weighted to previtamin D3 -weighted doses. We also give the ASCF for each season of the year in the northern hemisphere every 5° from 30°N to 60°N, based on ozone values. These ASCF, along with geometry conversion factors and other information, can give better vitamin D3 estimates from erythemally weighted outdoor doses. [source] What is plant behaviour?,PLANT CELL & ENVIRONMENT, Issue 6 2009ANTHONY TREWAVAS ABSTRACT The nature of plant behaviour is discussed, and it is concluded that it is best described as what plants do. The possibility that plant behaviour is simply signal-induced phenotypic plasticity is outlined, and some limitations of this assumption are considered. Natural environments present many challenges to growing plants, and the consequent signalling that plants perceive is becoming extremely complex. Plant behaviour is active, purposeful and intentional, and examples are discussed. Much plant behaviour, concerned with stress and herbivory, is also based on an assessment of the future likelihood of further damaging episodes and is therefore predictive. Plant behaviour involves the acquisition and processing of information. Informational terminology provides a suitable way of incorporating the concepts of learning, memory and intelligence into plant behaviour, capabilities that plants are rarely credited with. Finally, trade-offs, cost,benefit assessments and decision making are common plant behavioural attributes. It is suggested that intelligent assessments that involve the whole plant are essential to optimize these adaptive capabilities. [source] Rational Analyses of Information Foraging on the WebCOGNITIVE SCIENCE - A MULTIDISCIPLINARY JOURNAL, Issue 3 2005Peter Pirolli Abstract This article describes rational analyses and cognitive models of Web users developed within information foraging theory. This is done by following the rational analysis methodology of (a) characterizing the problems posed by the environment, (b) developing rational analyses of behavioral solutions to those problems, and (c) developing cognitive models that approach the realization of those solutions. Navigation choice is modeled as a random utility model that uses spreading activation mechanisms that link proximal cues (information scent) that occur in Web browsers to internal user goals. Web-site leaving is modeled as an ongoing assessment by the Web user of the expected benefits of continuing at a Web site as opposed to going elsewhere. These cost,benefit assessments are also based on spreading activation models of information scent. Evaluations include a computational model of Web user behavior called Scent-Based Navigation and Information Foraging in the ACT Architecture, and the Law of Surfing, which characterizes the empirical distribution of the length of paths of visitors at a Web site. [source] Nitrogen fertilisation in coriander (Coriandrum sativum L.): a review and meta-analysisJOURNAL OF THE SCIENCE OF FOOD AND AGRICULTURE, Issue 6 2009Alessandra Carrubba Abstract Nitrogen (N) fertilisation is one of the most important external inputs in assessing coriander seed yield and plant growth. Recent concerns related to the misuse of N fertilisers in agricultural environments, however, stress the opportunity for a fine-tuning of N management in order to optimise the use of this element, avoiding losses and reducing environmental hazards. In this study, some results from the literature concerning N fertilisation in coriander are reviewed and, by means of statistical analysis, an attempt is made to derive from them some general suggestions about practices of N fertilisation. In most cases examined, N fertilisation allowed a 10,70% increase in seed yields in comparison with each respective untreated control. The efficiency of use of this element, however, has proven to be greatly dependent on the overall fertility conditions of the growing site. The greatest yield advantages were actually found in more favourable environments, whereas in low-yielding environments plants reached their maximum yield with a comparatively reduced N supply. In low-yielding environments a careful risk/benefit assessment of this practice is therefore advisable. No definite conclusion could be drawn at this stage about essential oil yield and composition in relation to N fertilisation. Copyright © 2009 Society of Chemical Industry [source] | |||||||||||||