• YAKHAK HOEJI
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• v.47 no.2
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• pp.104-109
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• 2003

The present paper reviews the notion and comparison of the Korea Food and Drug Administration(KFDA) general pharmacology and the International Conference on Harmonisation (ICH) safety pharmacology. General pharmacology or safety pharmacology is termed the study to determine the potential of a compound to induce adverse pharmacological effects. KFDA general pharmacology studies have been considered an important component in drug safety assessment and these were originally referred to those designed to examine effects other than the primary therapeutics effect of a drug candidate. The KFDA notified the Guideline for General Pharmacology in 1997. Safety pharmacology studies were focused on identifying adverse effects on physiological functions. In the ICH came into place S7A Safety Pharmacology Studies for Human Pharmaceuticals in 2001. A new chemical entity should be assessed for its side effects, initially in those physiological systems which are generally agreed to be the key systems that are essential for life; these "core system" include the central nervous system, cardiovascular system and respiratory system in safety pharmacology studies. These studies should be performed in compliance with Good Laboratory Practice (GLP).

• Proceedings of KOSOMES biannual meeting
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• 2018.06a
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• pp.65-65
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• 2018

• Transactions of the Korean Society of Mechanical Engineers B
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• v.37 no.10
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• pp.961-969
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• 2013

In this study, the numerical analysis of a turbulent flow around both a staggered and an inline tube bundle was conducted using ANSYS CFX V.13, a commercial CFD software. The flow was assumed to be steady, incompressible, and isothermal. According to the CFD Best Practice Guideline, the sensitivity study for grid size, accuracy of the discretization scheme for convection term, and turbulence model was conducted, and its result was compared with the experimental data to estimate the applicability of the CFD Best Practice Guideline. It was concluded that the CFD Best Practice Guideline did not always guarantee an improvement in the prediction performance of the commercial CFD software in the field of tube bundle flow.

• Journal of the Korean Society of Safety
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• v.27 no.5
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• pp.164-170
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• 2012

In this study, a new technique for detecting near miss using 4M risk assessment method is suggested. Until now, the safety education with instances of near miss has just been progressed in most industrial settings, without any systematic guideline. By menas of appling 4M risk assessment method, the organized technique, which could effectively manage the fundamental prevention of industrial accident in advance, is developed. The organized technique of near miss-management suggested in this study will take an effective role in basically expanding the application of risk assessment method, as well as in contributing the activity of zero-accident as a safety guideline in hazardous workshops.

• Journal of Biomedical Engineering Research
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• v.31 no.6
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• pp.434-437
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• 2010

For approval of medical devices manufactured or imported, submission of technical documents as well as the application form is required. The manufacturer (or importer) should properly identify the raw materials the applied product is made of and the manufacturing processes the product undergoes before it is shipped in the application form. In the technical documents, scientific data to evaluate the efficacy, safety, and quality of the applied product that has been described in the application form should be provided. Therefore, identifying the raw materials that were used for the parts of the applied product and describing the physical and chemical characteristics of the raw materials are quite important and essential in ensuring the efficacy, safety, and quality of the applied product. To describe the physical and chemical characteristics of the raw materials correctively, the applicant is required to have broad knowledge in the scientific fields such as chemical, polymer, metal, and ceramic science and engineering. But most of the applicant are not experts in these fields, so that the description in the application form often includes wrong and improper descriptions. Thus, we developed a guideline which explains the raw materials for medical devices, show the their examples. The purpose of this description guideline is to help the applicant properly completing the "Raw materials or constituents and their volumes" part in the application form.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.34 no.2
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• pp.148-155
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• 2024

Objectives: Among the regulations that have recently attracted a lot of social attention in Regulation on Occupational Safety and Health Standards, we would like to specifically present the reasons why even companies with strong will to comply with regulations that are not effective or entail a number of legal problems, and suggest ways to improve them. Methods: The facts were confirmed and identified through various methods such as interviews and meetings with labor inspectors who enforce the Regulation on Occupational Safety and Health Standards and safety officials at industrial sites experiencing them. Results: Due to the lack of effectiveness in Regulation on Occupational Safety and Health Standards, there are not a few areas that do not function properly as a preventive standard. Although operating the regulatory nature of punishment as an administrative guideline without basing it on Regulation on Occupational Safety and Health Standards is a direct violation of the principles of the administration of the rule of law, there are many expedient ways to replace what should be placed in this rule as just an administrative guideline. Conclusions: It should be prioritized to explicitly stipulate effective regulations within the Regulation on Occupational Safety and Health Standards. In addition, as regulations on occupational safety and health standards play a large part in preventing industrial accidents, comprehensive and practical measures are indispensable rather than fragmented and formal measures to ensure that these rules function properly in the prevention industrial accidents.

• 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 Biomedical Engineering Research
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• v.40 no.6
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• pp.250-259
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• 2019

Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

• YAKHAK HOEJI
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• v.55 no.4
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• pp.345-351
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• 2011

Gastritis is the most common disease among Korean. The demand for the development of gastritis drugs has been increasing. Currently, however, there is no guideline available for the clinical evaluation of gastritis drugs worldwide. As a consequence, domestic and international pharmaceutical companies make errors in the drug development processes, and it becomes difficult for them to establish the scientific validity and objectivity of newly developed drugs. The objective of this study was to develop the Guideline for Clinical Trials Evaluation of Gastritis which can be used in improving the quality and consistency of clinical trials. First, we collected and reviewed the clinical trials on gastritis drugs that were available from Japan Pharmaceuticals and Medical Devices Agency and Korea Food and Drug Administration (KFDA), and investigated the recent research trends on clinical trials of gastritis drugs. Reviewers from KFDA and National Institute of Food and Drug Safety Evaluation and scientific experts from the pharmaceutical industries developed the guidelines through regularly scheduled meetings. Opinions and consultation from academic fields and industry experts were also obtained. This project will provide the clinical trial practitioners, investigator and reviewers the scientific and rational guidelines for performance and evaluation of clinical trials for gastritis drugs. Furthermore, we hope this guideline contributes to establishing the national competitiveness, improving the quality of clinical trial, and encouraging researches on drug development for gastritis.

• Proceedings of the Korean Nuclear Society Conference
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• 1997.05a
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• pp.233-238
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• 1997

본 논문에서는 Safety-critical 소프트웨어를 위한 V'||'&'||'V 지침서(guideline) 개발 방법론을 제시한다. 즉, 기존의 산업계 표준인 IEEE Std-1012, IEEE Std-1059에서 논의되고 있는 개념을 근간으로 "독립성(independence)", "소프트웨어 안전성 분석(software safety analysis)", "COTS 평가(evaluation) 기준", "다른 보증(assurance) 조직들간의 관련성(relationship)" 등의 필수 안전 항목들을 추가하여 원전 안전성 시스템(NPP safety system)을 위한 V'||'&'||'V 지침서 개발 방법론을 제시하였다 제시된 방법론에는 V'||'&'||'V 지침서의 범위(scope), 승인기준(acceptance criteria) 부분인 지침서 프레임(guideline framework), V'||'&'||'V activities 및 methods 부분인 타스크(task) entrance 및 exit 기준(criteria), 리뷰 및 감사(review and audit), 테스팅 그리고 V'||'&'||'V material의 QA 레코드(records) 및 형상관리, 소프트웨어 검증 및 확인 계획서(Software Verification and Validation Plan : SVVP) 생성 등의 내용을 기술하고, Safety-critical 소프트웨어 V'||'&'||'V 방법론도 함께 제시하였다.