• Korean Journal of Air-Conditioning and Refrigeration Engineering
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• v.29 no.10
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• pp.538-550
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• 2017

In a PWR (Pressurized Water Reactor), the appropriate heat removal from the surface of fuel rod bundle is important for ensuring thermal margins and safety. Although many CFD (Computational Fluid Dynamics) software have been used to predict complex flows inside fuel assemblies with mixing vanes, there is no domestic regulatory guideline for the comprehensive evaluation of CFD software. Therefore, from the nuclear regulatory perspective, it is necessary to perform the systematic assessment and prepare the domestic regulatory guideline for checking whether valid CFD software is used for nuclear safety problems. In this study, to provide systematic evaluation and guidance on the applicability of CFD software to the domestic nuclear safety area, the results of the sensitivity analysis for the effect of the discretization scheme accuracy for the convection terms and turbulence models, which are main factors that contribute to the uncertainty in the calculation of the nuclear safety problems, on the prediction performance for the turbulent flow distribution inside the fuel assembly with split-type mixing vanes were explained.

• Proceedings of the Korean Nuclear Society Conference
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• 2005.10a
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• pp.536-537
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• 2005

• Journal of Veterinary Science
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• v.22 no.1
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• pp.6.1-6.6
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• 2021

Stem cell-based products (SCPs) are an emerging field of veterinary medicine that focuses on the regeneration, repair, or replacement of damaged tissues or organs. However, there are some issues in applying the traditional regulatory guideline for the approval of SCPs as veterinary medicinal products. This article describes the positions of Korea, US, and EU regarding SCPs, and compares the regulatory guidelines of each country for their safety evaluation. Although there are some differences in the regulatory guidelines, similar considerations in identifying the quality of SCPs and their safety has adopted. Overall, these guidelines need to be harmonized among countries.

• 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.

• Journal of Environmental Impact Assessment
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• v.2 no.2
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• pp.95-103
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• 1993

EIA has been introduced as a tool for environment protection into promulgation of the Environment Preservation Act in 1977, which replaced the Pollution Control Act in Korea. EIA system has been improved with the enlargement of project type, public participation, guideline improvement, and regulatory development. Recently, Environmental Impact Assessment(EIA) Act will have an important role for sustainable development. This article deals with regulatory development, implementation order, EIA project type, and EIS preparation guidelines by Act promulgated and amended, also it explains comparison analysis of Environmental Policy Act and Environment Impact Assessment Act Major results are summarized in the table.

• YAKHAK HOEJI
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• v.55 no.5
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• pp.426-431
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• 2011

This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the development and approval of stereoisomeric drugs in US, EU, Canada and Japan. The important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substance 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. The regulatory documents adopted in major countries for the safety and efficacy evaluation of stereoisomeric drugs were investigated with the focus on three major categories mentioned above. For the regulatory approval of stereoisomeric drugs in Korea, it is expected that the investigated results obtained in this study will be useful for the basic materials to ensure the safety and efficacy of stereoisomeric drugs as well as the stereochemical issues in chiral drug development in domestic pharmaceutical company.

• Proceedings of the PSK Conference
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• 2003.04a
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• pp.117.2-118
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• 2003

Sample size calculations plays an important role in a bioequivalence trials and is determined by considering power under the alternative hypothesis. The regulatory guideline recommends that $2{\times}2$ crossover design is conducted and raw data is log-transformed for statistical analysis. In this paper, we discuss the sample size calculation in $2{\times}2$ crossover design with the log-transformed data.

• Nuclear Engineering and Technology
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• v.50 no.8
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• pp.1289-1297
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• 2018

Preliminary surface soil Derived Concentration Guideline Levels (DCGLs) were derived conforming to the Multi-Agency Radiation Site Survey and Investigation Manual (MARSSIM) procedure for the site release and reuse of Kori Unit 1 in Korea. Based on the decommissioning experiences of the U.S. nuclear power plants, a suite of residual radionuclides was determined, and uncertainties contributed to the resultant dose by the input parameters were quantified via the sensitivity analysis of parameters. The peak of the mean dose was obtained via the probabilistic analysis of the RESRAD (RESidual RADioactivity)-ONSITE code. Consequently, $DCGL_w$ of Kori Unit 1 in accordance with two scenarios, industrial worker and residential farmer scenario, were derived and the results were compared respectively with other NPPs. It could be used as a basic guideline for establishing regulatory standards for reuse planning, designing the site characterization surveys and implementing final status survey (FSS).

• 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.

• Korean Journal of Clinical Pharmacy
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• v.29 no.4
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• pp.267-277
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• 2019

Backgrounds: With the globalization of drug development, multi-regional clinical trials (MRCTs) have emerged to facilitate rapid availability of medicines to patients worldwide. The present study aimed to has explored attitudes and perceptions towards adopting the Korean MRCT guideline. Methods: An online survey, consisting of 16 questions, classified into two subjects, was administered to stakeholders in Korea. Most quantitative components were measured using the Likert scales. A content analysis of the qualitative components was carried out to identify the keywords in open-ended responses. Results: A total of 94 survey responses were analyzed: 51 participants from pharmaceutical companies, 11 from clinical research organizations, and 21 from clinical trial centers. The content of the guideline was rated as appropriate for clarity, acceptability, and applicability (96.8, 96.8, and 93.6%, respectively). The local environmental impact of the systemic/political, academic/technical, and industrial/economical aspects of the guideline was rated as appropriate at 95.7, 97.9, and 91.5%, respectively. The suggested adoption period was 1~2 years (40, 42.6%). The concept and individuals' domestic circumstances were the key problems affecting the clarity, applicability, and local environmental impact of the guideline. Conclusion: The Korean MRCT guideline was well-developed. Their overall impact on the local environmental impact of MRCTs in Korea was expected to be beneficial, but methods are needed to minimize the negative impacts. The findings of this study can inform the priorities for the future adoption of the guideline in Korea.