980 resultados para QUALITY CONTROL OF MEDICINES
Resumo:
Objectives - Review available guidance for quality assurance (QA) in mammography and discuss its contribution to harmonise practices worldwide. Methods - Literature search was performed on different sources to identify guidance documents for QA in mammography available worldwide in international bodies, healthcare providers, professional/scientific associations. The guidance documents identified were reviewed and a selection was compared for type of guidance (clinical/technical), technology and proposed QA methodologies focusing on dose and image quality (IQ) performance assessment. Results - Fourteen protocols (targeted at conventional and digital mammography) were reviewed. All included recommendations for testing acquisition, processing and display systems associated with mammographic equipment. All guidance reviewed highlighted the importance of dose assessment and testing the Automatic Exposure Control (AEC) system. Recommended tests for assessment of IQ showed variations in the proposed methodologies. Recommended testing focused on assessment of low-contrast detection, spatial resolution and noise. QC of image display is recommended following the American Association of Physicists in Medicine guidelines. Conclusions - The existing QA guidance for mammography is derived from key documents (American College of Radiology and European Union guidelines) and proposes similar tests despite the variations in detail and methodologies. Studies reported on QA data should provide detail on experimental technique to allow robust data comparison. Countries aiming to implement a mammography/QA program may select/prioritise the tests depending on available technology and resources.
Resumo:
Intensity Modulated Radiotherapy (IMRT) is a technique introduced to shape more precisely the dose distributions to the tumour, providing a higher dose escalation in the volume to irradiate and simultaneously decreasing the dose in the organs at risk which consequently reduces the treatment toxicity. This technique is widely used in prostate and head and neck (H&N) tumours. Given the complexity and the use of high doses in this technique it’s necessary to ensure as a safe and secure administration of the treatment, through the use of quality control programmes for IMRT. The purpose of this study was to evaluate statistically the quality control measurements that are made for the IMRT plans in prostate and H&N patients, before the beginning of the treatment, analysing their variations, the percentage of rejected and repeated measurements, the average, standard deviations and the proportion relations.
Resumo:
The capacity to use geologic materials (soil and rock) that are available in the surrounding environment is inherent to the human civilization and has contributed to the evolution of societies throughout the course of history. The use of these materials in the construction of structures such as houses, roads, railways or dams, stirred the improvement of socioeconomic and environmental conditions. Several reports of structural problems on embankments can be found throughout history. A considerable number of those registers can be linked to inadequate compaction, demonstrating the importance of guaranteeing a suitable quality of soil compaction. Various methodologies and specifications of compaction quality control on site of earthworks, based on the fill moisture content and dry unit weight, were developed during the 20th century. Two widely known methodologies are the conventional and nuclear techniques. The conventional methods are based on the use of the field sand cone test (or similar) and sampling of material for laboratory-based testing to evaluate the fill dry unit weight and water content. The nuclear techniques measure both parameters in the field using a nuclear density gauge. A topic under discussion in the geotechnical community, namely in Portugal, is the comparison between the accuracy of the nuclear gauge and sand cone test results for assessing the compaction and density ratio of earth fills, particularly for dams. The main purpose of this dissertation is to compare both of them. The data used were acquired during the compaction quality control operations at the Coutada/Tamujais dam trial embankment and core construction. This is a 25 m high earth dam located in Vila Velha de Rodão, Portugal. To analyse the spatial distribution of the compaction parameters (water content and compaction ratio), a 3D model was also developed. The main results achieved are discussed and finally some considerations are put forward on the suitability of both techniques to ensure fill compaction quality and on additional research to complement the conclusions obtained.
Resumo:
Rigorous organization and quality control (QC) are necessary to facilitate successful genome-wide association meta-analyses (GWAMAs) of statistics aggregated across multiple genome-wide association studies. This protocol provides guidelines for (i) organizational aspects of GWAMAs, and for (ii) QC at the study file level, the meta-level across studies and the meta-analysis output level. Real-world examples highlight issues experienced and solutions developed by the GIANT Consortium that has conducted meta-analyses including data from 125 studies comprising more than 330,000 individuals. We provide a general protocol for conducting GWAMAs and carrying out QC to minimize errors and to guarantee maximum use of the data. We also include details for the use of a powerful and flexible software package called EasyQC. Precise timings will be greatly influenced by consortium size. For consortia of comparable size to the GIANT Consortium, this protocol takes a minimum of about 10 months to complete.
Formulation and Implementation of Air Quality Control Pogrammes : Patterns of Interest Consideration
Resumo:
This article investigates some central aspects of the relationships between programme structure and implementation of sulphur dioxide air quality control policies. Previous implementation research, primarily adopting American approaches, has neglected the connections between the processes of programme formulation and implementation. 'Programme', as the key variable in implementation studies, has been defined too narrowly. On the basis of theoretical and conceptual reflections and provisional empirical results from studies in France, Italy, England, and the Federal Republic of Germany, the authors demonstrate that an integral process analysis using a more extended programme concept is necessary if patterns of interest recognition in policies are to be discovered. Otherwise, the still important question of critical social science cannot be answered, namely, what is the impact of special interests upon implementation processes.
Resumo:
Gene expression data from microarrays are being applied to predict preclinical and clinical endpoints, but the reliability of these predictions has not been established. In the MAQC-II project, 36 independent teams analyzed six microarray data sets to generate predictive models for classifying a sample with respect to one of 13 endpoints indicative of lung or liver toxicity in rodents, or of breast cancer, multiple myeloma or neuroblastoma in humans. In total, >30,000 models were built using many combinations of analytical methods. The teams generated predictive models without knowing the biological meaning of some of the endpoints and, to mimic clinical reality, tested the models on data that had not been used for training. We found that model performance depended largely on the endpoint and team proficiency and that different approaches generated models of similar performance. The conclusions and recommendations from MAQC-II should be useful for regulatory agencies, study committees and independent investigators that evaluate methods for global gene expression analysis.
Distributional Issues in Regulatory Policy Implementation : the Case of Air Quality Control Policies
Resumo:
Longitudinal joint quality control/assurance is essential to the successful performance of asphalt pavements and it has received considerable amount of attention in recent years. The purpose of the study is to evaluate the level of compaction at the longitudinal joint and determine the effect of segregation on the longitudinal joint performance. Five paving projects with the use of traditional butt joint, infrared joint heater, edge restraint by milling and modified butt joint with the hot pinch longitudinal joint construction techniques were selected in this study. For each project, field density and permeability tests were made and cores from the pavement were obtained for in-lab permeability, air void and indirect tensile strength. Asphalt content and gradations were also obtained to determine the joint segregation. In general, this study finds that the minimum required joint density should be around 90.0% of the theoretical maximum density based on the AASHTO T166 method. The restrained-edge by milling and butt joint with the infrared heat treatment construction methods both create the joint density higher than this 90.0% limit. Traditional butt joint exhibits lower density and higher permeability than the criterion. In addition, all of the projects appear to have segregation at the longitudinal joint except for the edge-restraint by milling method.
Resumo:
Selectome (http://selectome.unil.ch/) is a database of positive selection, based on a branch-site likelihood test. This model estimates the number of nonsynonymous substitutions (dN) and synonymous substitutions (dS) to evaluate the variation in selective pressure (dN/dS ratio) over branches and over sites. Since the original release of Selectome, we have benchmarked and implemented a thorough quality control procedure on multiple sequence alignments, aiming to provide minimum false-positive results. We have also improved the computational efficiency of the branch-site test implementation, allowing larger data sets and more frequent updates. Release 6 of Selectome includes all gene trees from Ensembl for Primates and Glires, as well as a large set of vertebrate gene trees. A total of 6810 gene trees have some evidence of positive selection. Finally, the web interface has been improved to be more responsive and to facilitate searches and browsing.
Resumo:
Asphalt pavements suffer various failures due to insufficient quality within their design lives. The American Association of State Highway and Transportation Officials (AASHTO) Mechanistic-Empirical Pavement Design Guide (MEPDG) has been proposed to improve pavement quality through quantitative performance prediction. Evaluation of the actual performance (quality) of pavements requires in situ nondestructive testing (NDT) techniques that can accurately measure the most critical, objective, and sensitive properties of pavement systems. The purpose of this study is to assess existing as well as promising new NDT technologies for quality control/quality assurance (QC/QA) of asphalt mixtures. Specifically, this study examined field measurements of density via the PaveTracker electromagnetic gage, shear-wave velocity via surface-wave testing methods, and dynamic stiffness via the Humboldt GeoGauge for five representative paving projects covering a range of mixes and traffic loads. The in situ tests were compared against laboratory measurements of core density and dynamic modulus. The in situ PaveTracker density had a low correlation with laboratory density and was not sensitive to variations in temperature or asphalt mix type. The in situ shear-wave velocity measured by surface-wave methods was most sensitive to variations in temperature and asphalt mix type. The in situ density and in situ shear-wave velocity were combined to calculate an in situ dynamic modulus, which is a performance-based quality measurement. The in situ GeoGauge stiffness measured on hot asphalt mixtures several hours after paving had a high correlation with the in situ dynamic modulus and the laboratory density, whereas the stiffness measurement of asphalt mixtures cooled with dry ice or at ambient temperature one or more days after paving had a very low correlation with the other measurements. To transform the in situ moduli from surface-wave testing into quantitative quality measurements, a QC/QA procedure was developed to first correct the in situ moduli measured at different field temperatures to the moduli at a common reference temperature based on master curves from laboratory dynamic modulus tests. The corrected in situ moduli can then be compared against the design moduli for an assessment of the actual pavement performance. A preliminary study of microelectromechanical systems- (MEMS)-based sensors for QC/QA and health monitoring of asphalt pavements was also performed.
The effects of real time control of welding parameters on weld quality in plasma arc keyhole welding
Resumo:
Joints intended for welding frequently show variations in geometry and position, for which it is unfortunately not possible to apply a single set of operating parameters to ensure constant quality. The cause of this difficulty lies in a number of factors, including inaccurate joint preparation and joint fit up, tack welds, as well as thermal distortion of the workpiece. In plasma arc keyhole welding of butt joints, deviations in the gap width may cause weld defects such as an incomplete weld bead, excessive penetration and burn through. Manual adjustment of welding parameters to compensate for variations in the gap width is very difficult, and unsatisfactory weld quality is often obtained. In this study a control system for plasma arc keyhole welding has been developed and used to study the effects of the real time control of welding parameters on gap tolerance during welding of austenitic stainless steel AISI 304L. The welding tests demonstrated the beneficial effect of real time control on weld quality. Compared with welding using constant parameters, the maximum tolerable gap width with an acceptable weld quality was 47% higher when using the real time controlled parameters for a plate thickness of 5 mm. In addition, burn through occurred with significantly larger gap widths when parameters were controlled in real time. Increased gap tolerance enables joints to be prepared and fit up less accurately, saving time and preparation costs for welding. In addition to the control system, a novel technique for back face monitoring is described in this study. The test results showed that the technique could be successfully applied for penetration monitoring when welding non magnetic materials. The results also imply that it is possible to measure the dimensions of the plasma efflux or weld root, and use this information in a feedback control system and, thus, maintain the required weld quality.
Resumo:
Citrus fruits are affected by the black spot disease caused by the fungus Guignardia citricarpa. Chitosan can be used as covering for fruits and may delay the ripening process and inhibit the growth of some fungi. Thus, the control of citrus black spot using chitosan and the fungicides thiabendazole and imazalil was assessed in addition to the physicochemical quality of 'Pêra Rio' oranges. The oranges were immersed into chitosan, thiabendazole or imazalil, and in chitosan mixed with both fungicides. The fruits were then stored at 25 °C, 80% RH, for 7 days and, after this storage period, subjected to physicochemical analyses. Chitosan in association with the fungicides reduced black spot in 'Pêra Rio' oranges and delayed the change in the orange skin colour from green to yellow during the postharvest storage. Total soluble solids, titratable acidity, pH, ascorbic acid content and ratio were not influenced by the treatments. Thus, chitosan applied with the fungicides thiabendazole and imazalil showed potential to control the development of black spot lesions on 'Pêra Rio' oranges during the postharvest period.
Resumo:
The increased awareness and evolved consumer habits have set more demanding standards for the quality and safety control of food products. The production of foodstuffs which fulfill these standards can be hampered by different low-molecular weight contaminants. Such compounds can consist of, for example residues of antibiotics in animal use or mycotoxins. The extremely small size of the compounds has hindered the development of analytical methods suitable for routine use, and the methods currently in use require expensive instrumentation and qualified personnel to operate them. There is a need for new, cost-efficient and simple assay concepts which can be used for field testing and are capable of processing large sample quantities rapidly. Immunoassays have been considered as the golden standard for such rapid on-site screening methods. The introduction of directed antibody engineering and in vitro display technologies has facilitated the development of novel antibody based methods for the detection of low-molecular weight food contaminants. The primary aim of this study was to generate and engineer antibodies against low-molecular weight compounds found in various foodstuffs. The three antigen groups selected as targets of antibody development cause food safety and quality defects in wide range of products: 1) fluoroquinolones: a family of synthetic broad-spectrum antibacterial drugs used to treat wide range of human and animal infections, 2) deoxynivalenol: type B trichothecene mycotoxin, a widely recognized problem for crops and animal feeds globally, and 3) skatole, or 3-methyindole is one of the two compounds responsible for boar taint, found in the meat of monogastric animals. This study describes the generation and engineering of antibodies with versatile binding properties against low-molecular weight food contaminants, and the consecutive development of immunoassays for the detection of the respective compounds.