• Toxicological Research
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• v.22 no.2
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• pp.109-116
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• 2006

Safety pharmacology studies are conducted to investigated the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above. In the International Conference on Harmonisation (ICH), the guideline 'S7A: Safety Pharmacology Studies for Human Pharmaceuticals' has been developed and reached Step 5 of the ICH process in 2001. Now the Korea Food and Drug Administration (KFDA) are going to transfer 'The Guideline for General Pharmacology' into 'The Guideline for Safety Pharmacology'. Safety pharmacology studies should be performed in compliance with Good Laboratory Practice (GLP). Thus, the present paper reviews the Japanese GLP guidelines for pharmaceuticals to help the conduct and inspection of safety pharmacology studies in compliance with GLP. We also reviewed the ICH guidelines 'S7B revised : The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals' and 'E14 : The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs' to apply our drug approval systems.

• Journal of Environmental Impact Assessment
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• v.22 no.5
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• pp.537-546
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• 2013

In the Seoul Metropolitan Area(SMA) photochemical air pollutants, nitrogenic compound and particulate matters have increased substantially due to mobile sources, power plants and so on. Therefore 'Special Act on Seoul Metropolitan Air Quality Improvement' was enacted on 2003 in order to improve air quality in the SMA. According to the Special Act, Central and local government have developed the state implementation plan(SIP) to reduce air pollutant emissions from various local sources. One of the key elements of the SIP development is the air quality modeling since modeling results can be used to establish emissions control strategies as well as to demonstrate attainment of air quality goals for ozone, particulate matter, and so on. Air quality modeling, therefore, can be usefully utilized to investigate the effects of government's efforts according to control strategies or measures. Using the air quality model, we can determine whether the implementation plan should be revised or not. A number of questions, however, has been raised concerning accuracy, consistency and transparency of modeling results because if we do not trust modeling results, all the measures dependent on modeling becomes in vain. So, without dealing with these questions, we can not guarantee the reliability and utilizability of air quality modeling results. In this study, we tried to establish standard methodology for air quality modeling in order to ensure consistency and transparency of modeling results used in the development and evaluation of national air policy. For this purpose, we established air quality modeling guideline to provide or recommend modeling procedures, vertical and horizontal domains, input data of meteorological and air quality modeling and so on.

• YAKHAK HOEJI
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• v.57 no.3
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• pp.173-186
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• 2013

To ensure the safe use of pharmaceuticals in the market, US, EU and Japan reached a consensus to adopt ICH harmonised tripartite guideline "E2E Pharmacovigilance Planning" in 2004. Subsequently these regions established and implemented new pharmaceutical safety management systems for patients based on ICH E2E guideline and Risk Evaluation and Mitigation Strategy (REMS) in US or Risk Management Plan (RMP) in EU and Japan. In this study we investigated these new foreign systems and suggested a way to improve Korea's regulatory system for pharmaceutical safety management under Korea Pharmaceutical Law in the view of international harmonization.

• Transactions of the Korean Society of Mechanical Engineers A
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• v.29 no.10 s.241
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• pp.1392-1398
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• 2005

API 581 guideline provides a methodology for calculating the risks of equipments in refinery or petrochemical plant. However, especially in part of the consequence of failure, there is a major limitation of its application to the petrochemical plant directly since only a representative material is considered in calculating the risk while the equipment is composed of numerous materials. The objectives of this paper are to propose an enhanced risk-based inspection (RBI) technique to resolve shortcomings inclusive of the above issue and to assess the risks of typical petrochemical equipments. In this respect, a program incorporating material database was developed to fully incorporate the characteristics of different materials. The proposed RBI program consists of qualitative, semi-quantitative and quantitative risk evaluation modules in which toxic materials as well as representative materials were selected automatically for comparison to those in the current guideline. It has been applied to assess the risks of equipments in ethylene facilities of petrochemical plants. Thereby, more realistic evaluation results were obtained and applicability of the proposed RBI program was proven.

• Proceeding of Spring/Autumn Annual Conference of KHA
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• 2011.04a
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• pp.121-126
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• 2011

This study is a preliminary study to develop design guidelines on shared spaces of apartment for healthy housing. It was tried to set the basic direction of the guideline development by comparing and analyzing related literatures based on the previously identified evaluation indicators of healthy housing of apartment. The major findings were as followings: 1) based on the research conducted before, the characters of shared spaces for healthy housing were classified as physical, mental and social dimensions. 2) According to the comparison and analysis of relevant standards and guidelines, focuses were mostly on the physical dimension, particularly on the human traffic lines of the convenience attributes. Other focuses were on the attractiveness of the apartment complex of the vitality attribute under the mental dimension, and community facilities of the residential stability attributes under the social dimension. Therefore, it was identified that it is required to take complementary measure regarding mental and social dimensions, and design concrete steps to include different attributes of each dimension, in order to develop comprehensive guidelines for shared space.

• Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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• 2006.11a
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• pp.880-883
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• 2006

The reduction of tool vibration has been a serious issue for both employers and workers because of the risks of vibration transmitted to the workers. In this study a hand-arm vibration measurement and evaluation system was developed based on ISO 5349:2001 and used for analyzing relation of vibration level and components of tools. This system consists of a notebook PC installed a LabVIEW program and the data acquisition system including two 3-axial accelerometers and a NI-DAQ card. Vibration measurement tests were conducted for eight angle grinders and four impact wrenches where 3 subjects were used for each of the tools. The relation between different components of each tool and its vibration total value made it possible to set-up a guideline of tool design. In the past engineers developed tools by using their experience and intuition, but by using this system it became possible to design tool components so as to minimize the risks of hand-transmitted vibration.

• Journal of Environmental Impact Assessment
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• v.3 no.1
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• pp.9-30
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• 1994

Environmental Impact Assessment System, ever since its enactment in Korea fourteen years ago, has been steadily improved by introduction and implementation of new concepts and methodologies which include Environmental Impact Statement(EIS) preparation technique, selection of environmental factors, and the like. However, current guideline requires that every EIS, regardless of the specifics of the project type or characteristics of the site, must evaluate and study for all twenty-two environmental factors as set forth in the regulation. The situation causes many undesirable problems like; lack of site specific evaluation in most EISs, over-sized EIS drafts, consuming too much time and costs for EIS preparation, and so on. The objectives of this study are: - To establish a set of criteria to classify the types of the projects in terms of features of the project content and the characteristics of the site area. - To establish a guideline for selecting major environmental factors of the project type criteria, and - To provide basic materials for the preparation of complets draft EIS of the Amendment of Environmental Impact Assessment Act.

• Journal of Biomedical Engineering Research
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• v.31 no.2
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• pp.129-133
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• 2010

Intense pulsed light(IPL) is a photo-therapeutic medical device using xenon lamps with optical characteristics of incoherence, defocusing, and polychromatic. IPL has been recognized as a representative medical therapeutic device with growth of domestic skin care market. However, there is no standard regulation manual and guideline to evaluate the safety and performance of IPL. International Electrotechnical Commission(IEC) is being statued "Technical Report IEC TR 60825-16" which is a guidelines for the safe use of intense light source equipment on humans and animals. In this study, a standard Korea Food & Drug Administration (KFDA) regulation for the safety and performance of IPL was suggested by developing minimal evaluation methods for optical parameters of IPL such as output energy density, pulse mode, spot size, wavelength and uniformity of output light. We expect that this study may be a step to statue a standard regulation manual and guideline for IPLs used in domestic.

• Journal of The Korean Association For Science Education
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• v.21 no.5
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• pp.867-892
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• 2001

In both Korea and the U.S., science education leaders and specialists insist that there is a shortage of curricula to address the new national science education guidelines in support of reform. This paper addresses development of new curricula for science education reform in the hopes of facilitating further development of guideline-based curricula. We examine Korean and U.S. thematic-based (Korean Science Field Trip at Cultural Sites Program and U.S. Graduate Teaching Fellows in K-12 Education) and project-centered (Korean Teachers for Exciting Science and U.S. Foundational Approaches in Science Teaching Program) programs. Using the criteria of rationale for curriculum, content and scope, processes of implementation, and assessment strategies, we identify the curricular components that are common across four successful secondary science programs and determine which of these components address the national guidelines. Our findings indicate that common components of these four programs meet the expectations of the science guidelines being used to revamp science education in both countries. Therefore, these programs not only engage secondary students and teachers in practicing successful science education, but also lead to successful science education practices that can be incorporated in the future development of curriculum to support secondary science reform.

• Toxicological Research
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• v.21 no.4
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• pp.271-278
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• 2005

Reproductive and developmental toxicology is concerned with various physical or chemical agents interfering with fertility in both gender or normal growth of offsprings. Reproductive and developmental toxicology is rather a complex science, with many fields, i.e., various endpoints are involved and many different mechanisms of action. For that reason, diverse aspects must be considered when attempting to assess possible adverse health effects in the area of reproductive and developmental toxicology. The thalidomide tragedy made it clear to regulatory authorities around the world that systematic, comprehensive evaluation of the reproductive cycle was needed to adequately evaluate the potential of medicinal drugs to impair the process of reproduction or the development of embryos, fetuses, and children. International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) and U.S. Food and Drug Administration (FDA) developed a guideline to assess the reproductive and developmental toxicity. Also these guidelines have since been applied to the detection and regulation of environmental toxicants, food additives, and so on. Although it was hoped that testing procedures of guideline would be updated constantly to reflect the current state of the science in reproductive and developmental toxicology, it was not until this decade that regulatory guidelines and testing methods have been altered in a significant way. In this paper, we would like to present the recommended approaches and recent trends for improvement of testing guidelines or experimental methods in reproductive and developmental toxicology.