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Detailed Guidance (detailed + guidance)
Selected AbstractsEvaluation of the skin sensitizing potency of chemicals by using the existing methods and considerations of relevance for elicitationCONTACT DERMATITIS, Issue 1 2005David A. Basketter The Technical Committee of Classification and Labelling dealing with harmonized classification of substances and classification criteria under Directive 67/548/EEC on behalf of the European Commission nominated an expert group on skin sensitization in order to investigate further the possibility for potency consideration of skin sensitizers for future development of the classification criteria. All substances and preparations should be classified on the basis of their intrinsic properties and should be labelled accordingly with the rules set up in the Directive 67/548/EEC. The classification should be the same under their full life cycle and in the case that there is no harmonized classification the substance or preparation should be self-classified by the manufacturer in accordance with the same criteria. The Directive does not apply to certain preparations in the finished state, such as medical products, cosmetics, food and feeding stuffs, which are subject to specific community legislation. The main questions that are answered in this report are whether it would be possible to give detailed guidance on how to grade allergen potency based on the existing methods, whether such grading could be translated into practical thresholds and whether these could be set for both induction and elicitation. Examples are given for substances falling into various potency groups for skin sensitization relating to results from the local lymph node assay, the guinea pig maximization test, the Buehler method and human experience. [source] Cost of compliance assessments and the water industry in England and WalesENVIRONMENTAL POLICY AND GOVERNANCE, Issue 5 2002Paul McMahon Environmental compliance cost assessments (CCAs) are being increasingly demanded and used in the water industry, in order to allow regulators to balance conflicting objectives. The 1999 periodic review of water company price limits concerned massive environmental expenditures, and consequently major use of CCAs. There were major differences between Ofwat (the economic regulator) and the water companies relating to the compliance costs submitted. The assumptions used by Ofwat vis-à-vis future efficiency savings and the cost of capital are notable causes of the differentials. There are a number of other reasons why this differential might have arisen, including gaming. However, the principal cause might be more a real lack of knowledge on the part of companies of future efficiencies and the actual costs of projects. The CCAs produced in the water industry have had massive impact on policy design. A number of specific improvements to CCA are identified. These changes relate to increased collaboration between industry and regulators in working groups to design/approve, inter alia, regulatory methodologies for use in the periodic review. More detailed guidance is required for preparation of a CCA. Further use of compliance cost databases is recommended. The entire process would be facilitated by increased training and awareness raising of economics for the engineers largely responsible for preparation of CCAs. Copyright © 2002 John Wiley & Sons, Ltd. and ERP Environment. [source] Toward a more efficient and effective neurologic examination for the 21st century,EUROPEAN JOURNAL OF NEUROLOGY, Issue 12 2005T. H. Glick Practice pressures and quality improvement require greater efficiency and effectiveness in the neurologic examination. I hypothesized that certain ,marginal' elements of the examination rarely add value and that ,core' elements, exemplified by the plantar response (Babinski), are too often poorly performed or interpreted. I analyzed 100 published, neurologic clinicopathologic conferences (CPCs) and 180 ambulatory neurologic consultations regarding 13 hypothetically ,marginal' examination components (including ,frontal' reflexes, olfaction, jaw strength, corneal reflex, etc.); also, 120 exams on medical inpatients with neurologic problems, recording definitive errors. I surveyed the recalled practices of 24 non-neurologists and reviewed the literature for relevant data or guidance. In the CPCs the ,marginal' elements of the examination were rarely provided, requested, or used diagnostically, nor did they contribute in the 180 ambulatory consultations. In the chart review errors and omissions dominated testing of plantar responses, with missed Babinski signs in 14% of all cases and 77% of patients with Babinski signs. House officers harbored unrealistic expectations for performance of ,marginal' examination elements. Most textbooks omit detailed guidance (and none cite evidence) on achieving greater efficiency. Exams should be streamlined, while improving ,core' skills. Neurologists should apply evidence to update the exam taught to students and non-neurologists. [source] Emergency Department Surge Capacity: Recommendations of the Australasian Surge Strategy Working GroupACADEMIC EMERGENCY MEDICINE, Issue 12 2009David A. Bradt MD, FACEM Abstract For more than a decade, emergency medicine (EM) organizations have produced guidelines, training, and leadership for disaster management. However, to date there have been limited guidelines for emergency physicians (EPs) needing to provide a rapid response to a surge in demand. The aim of this project was to identify strategies that may guide surge management in the emergency department (ED). A working group of individuals experienced in disaster medicine from the Australasian College for Emergency Medicine Disaster Medicine Subcommittee (the Australasian Surge Strategy Working Group) was established to undertake this work. The Working Group used a modified Delphi technique to examine response actions in surge situations and identified underlying assumptions from disaster epidemiology and clinical practice. The group then characterized surge strategies from their corpus of experience; examined them through available relevant published literature; and collated these within domains of space, staff, supplies, and system operations. These recommendations detail 22 potential actions available to an EP working in the context of surge, along with detailed guidance on surge recognition, triage, patient flow through the ED, and clinical goals and practices. The article also identifies areas that merit future research, including the measurement of surge capacity, constraints to strategy implementation, validation of surge strategies, and measurement of strategy impacts on throughput, cost, and quality of care. [source] GIQAR position paper on ,Archiving and Good Laboratory Practice',QUALITY ASSURANCE JOURNAL, Issue 4 2005M. M. Brunetti Abstract Archiving of documents and specimens generated during a non-clinical laboratory study is a basic Good Laboratory Practice (GLP) requirement. The records and materials that should be archived as well as the characteristics and the organisation of archive facilities are addressed in the OECD Series on Principles of Good Laboratory Practice No. 1 (OECD Principles of Good Laboratory Practice (as revised in 1997) [1]. However, in recent years, questions concerning archiving have been raised and the need for a more detailed guidance on this matter has become evident The aim of the Society for Applied Pharmacological Sciences/Italian Group of Quality Assurance in Research (SSFA/GIQAR) working group on ,Archiving according to GLP' was to issue a position paper, present it for discussion in an ad hoc round table with representatives of the Italian GLP monitoring authority to promote common standards and to provide additional recommendations on storage and retention of records. Copyright © 2005 John Wiley & Sons, Ltd. [source] | ||||||||||