• Title/Summary/Keyword: Safety Evaluation

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Comparison of Clinical Development and Evaluation of Triple Antihypertensive Therapy in Advanced Foreign Countries (항고혈압 약물 3종 복합제에 대한 선진 외국의 임상자료 심사사례 비교)

  • Wang, So Young;Shon, Soo Jung;Um, Jung Yoon;Lim, Hwa Kyung;Lim, Sook;Kang, Seung Ho;Lee, Sun Hee
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.3
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    • pp.239-247
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    • 2013
  • Background: Fixed drug combinations are formulations containing two or more active ingredients in a single dosage form. Such combination therapies are commonly applied to improve efficacy, reduce adverse events and replace co-administration, etc. National and international guidelines for hypertension treatment recommend addition of other classes of antihypertensive drugs rather than incremental dose of mono-therapy, when blood pressure is not adequately controlled. Thus, many dual combinations of antihypertensive drugs have been approved and pharmaceutical companies are recently interested in developing antihypertensive triple combinations. Clinical trial designs for the fixed combinations are various depending on the target patients, dosage and clinical endpoints. Thereby, further discussions for the clinical trials of antihypertensive triple therapies are required regarding the indication claimed. Conclusion: This article provides a review for the assessment of the label and medical reports of the clinical trials on antihypertensive triple therapies in advanced foreign countries.

Case Study : Application of Specific Evaluation Criteria For Safety Circuit Design of EN ISO 13849-1 (사례 연구 : EN ISO 13849-1의 안전회로 설계를 위한 구체적 평가 기준의 적용)

  • Jung, Hwansuk;Lee, Dongju
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.41 no.1
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    • pp.94-101
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    • 2018
  • With the development of industrial technology and science, production and manufacturing facilities have been enhanced and improved, and the importance of the safety of workers has also been regulated and limited by various safety management methods. As a way to secure the safety of the workers from the production facility, the fail-safe and fool-proof methods are now being applied. Any possible insecure behavior and unsafe conditions can be removed by adopting the standards and specifications that are now secure the safety of workers and equipment. This research analyzes EN ISO 13849-1 international and European standards during CE certification. In order to secure acceptable reduced risks, the risk assessment process of ISO 12100 and the processes for reducing its risk are applied. In the current ISO 13849-1 standard, the criteria for the required performance level PLr (Required Performance Level) for the applicable risk and safety functions through the risk assessment are subjective and not subdivided. Therefore, the evaluation criteria are likely to cause judge's judgement error due to qualitative judgement. This research focuses on evaluation and acceptable performance level setting for the safety circuit of the equipment. We propose an objective and specific evaluation criteria to secure safety, and the proposed evaluation criteria are applied to the case study of the safety circuit for the equipment. In order to secure the safety of the entire safety circuit, the improvement of the MTTFd and DC level related to the SRP/CS (Safety-Related Parts of Control Systems)' lifetime is required for the future research.

A Basic Study on the Development of a BIM-based Realtime Performance Evaluation Technology for the User Life Safety in the Buildings (건물 내의 사용자 생활안전설계를 위한 BIM기반 실시간 성능검토 기술개발에 관한 기초연구)

  • Lee, Yun Gil
    • Journal of Korea Multimedia Society
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    • v.18 no.9
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    • pp.1058-1067
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    • 2015
  • Dweller's safety is one of the most important factors for the evaluation of building performance. The process of conventional safety design which is normally performed by the codes and designer's experiences is not enough to check the whole possibilities of unexpected accidents in the built environment. It means that the dwellers might be always exposed by the dangerous situation which should have been removed in the architectural design process. In order to solve this problem, this study intends to introduce a rule-based performance evaluation technology based on BIM(Building Information Modeling). The proposed technology focuses on the real time evaluation of dweller's safety in the ordinary life in the designed building alternatives and uses a commercial BIM tool as a design and evaluation platform.

A Study on the Development of ESG Safety Evaluation Index (ESG 안전 평가지표 개발에 관한 연구 )

  • Cheolhee Yoon;Keun-won Lee;Seungho Jung
    • Journal of the Korean Institute of Gas
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    • v.27 no.2
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    • pp.16-24
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    • 2023
  • ESG (environmental, social, governance) management is being introduced with the goal of sustainable development of the company in risk management, which identifies and judgement various risks that may occur in the industry. In the future, ESG evaluation will be used more as a value judgment tools for corporate sustainability. This ESG evaluation was used to manage the company's accident prevention level. Through morphological analysis of the current ESG evaluation system, it was found that the quantitative 'safety evaluation index' available in ESG was insufficient through analysis of safety evaluation items. In this study, domestic and foreign industrial accident data was analyzed, 'accident contributing factors' that required intensive management were derived, and major safety management items that needed supplementation were selected based on the results. ESG safety evaluation indicators were developed through the process of optimizing the selected items into evaluation factors suitable for 'accident prevention management'.

Development and Validation of an Official Analytical Method for Determination of Ipfencarbazone in Agricultural Products using GC-ECD (GC-ECD를 이용한 농산물 중 Ipfencarbazone의 신규분석법 개발 및 검증)

  • Jang, Jin;Kim, Heejung;Lee, Eun-Hyang;Ko, Ah-Young;Ju, Yunji;Kim, Sooyeon;Chang, Moon-Ik;Rhee, Gyu-Seek
    • The Korean Journal of Pesticide Science
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    • v.19 no.3
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    • pp.210-217
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    • 2015
  • Ipfencarbazone is a herbicide of the tetrazolinone class, and is believed to be an inhibitor of very long chain fatty acids (VLCFAs), which control cell division in weeds. The objective of this study was to develop and validate an official analytical method for ipfencarbazone determination in agricultural products. The ipfencarbazone residues in agricultural products were extracted with acetone, partitioned with n-hexane, and then purified through silica SPE cartridge. Finally, the analyte was quantified by gas chromatograph-electron capture detector (GC-ECD) and confirmed with gas chromatograph/mass spectrometer(GC/MS). The linear range of ipfencarbazone was 0.01 to 1.0 mg/L with the coefficient of determination ($r^2$) of 0.9999. The limit of detection (LOD) and quantification (LOQ) was 0.003 and 0.01 mg/kg, respectively. In addition, average recoveries of ipfencarbazone ranged from 80.6% to 112.3% at the different concentration levels LOQ, 10LOQ and 50LOQ, while the relative standard deviation was 2.2-8.6%. All values were consistent with the criteria ranges requested in the CODEX guidelines. Furthermore, and inter-laboratory study was conducted to validate the method. This proposed method for determination of ipfencarbazone residues in agricultural products can be used as an official analytical method.

Development of a Method for Analyzing the Nicotine Content in Synthetic Flavoring Substances as Unauthorized E-cigarette Liquid by Using HPLC (전자담배 액상 충진제와 유사한 합성착향료 중 니코틴의 HPLC 분석법 개발)

  • Kim, Jae-Young;Lee, Sang-Mok;Chang, Moon-Ik;Cho, Yoon-Jae;Lee, Han-Jin;Chae, Young-Sik;Rhee, Gyu-Sik
    • Korean Journal of Food Science and Technology
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    • v.45 no.6
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    • pp.693-699
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    • 2013
  • A simple, sensitive, and specific method for quantifying the nicotine content of synthetic favoring substances (SFS) was developed using high performance liquid chromatography (HPLC) with a photo-diode array detector (PDA). Nicotine was extracted from SFS samples by using an acid-base liquid-liquid extraction method with dichloromethane and distilled water. The nicotine content was quantified by HPLC/PDA (261.9 nm) with a $C_{18}$ column under a gradient of 10% acetonitrile with 20 mM ammonium formate (ammonia solution adjusted to pH 8.7) to 100% acetonitrile. The calibration curve, analyzed from concentration standards between 0.1 to 2 mg/L, presented linearity with a correlation coefficient ($r^2$)>0.9999. The limit of quantitation (LOQ) of nicotine in SFS was 0.4 mg/kg, and the average recoveries ranged from 76.4% to 96.3%. The repeatability of measurements, expressed as the coefficient of variation (CV%), ranged from 1.74 to 5.12%. This newly developed method for nicotine quantification in SFS can be considered an analytical method with an acceptable level of sensitivity and repeatability.

Detection of irradiated food using photostimulated luminescence and thermoluminescence (물리적 방법(PSL, TL)을 이용한 선종별 조사처리 식품의 검지 특성)

  • Jung, Yoo-Kyung;Lee, Ji-Yeon;Kang, Tae-Sun;Jo, Cheon-Ho;Lee, Jae-Hwang;Choi, Jang-Duck;Kwon, Ki-Sung
    • Korean Journal of Food Science and Technology
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    • v.48 no.5
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    • pp.399-404
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    • 2016
  • The applicability of photostimulated-luminescence (PSL) and thermoluminescence (TL) for the detection of 12 food materials (potato, onion, garlic, dried pumpkin, black mushroom, black soybean, Cheongkukjang powder, sea mustard, pepper powder, Ramyun soup, corn tea, and green tea powder) irradiated with an electron beam, gamma ray, and X ray at a range of 0.15 to 10 kGy was investigated. For PSL, negative results (less than 700 photon counts (PCs)) were observed from non-irradiated foods while the irradiated foods showed intermediate (879 to 2,414 PCs) and/or positive (19,951 to 65,919,035 PCs) values. In all irradiated samples, the maximum peak of the TL glow curve was observed between 150 and $250^{\circ}C$. Our findings demonstrate the successful application of PSL and TL to determine whether food items were irradiated or not. However, there were no significant differences among the radiation sources.

Studies on the Applications of TL and ESR Methods for the Detection of Spices, Berry Fruits and Pollen Extract Product (TL과 ESR 분석을 통한 일부 향신료, 장과류 및 화분가공추출물 검지 특성 연구)

  • Kim, Kyu-Heon;Son, Jin-Hyok;Kang, Yoon-Jung;Park, Hye-Young;Kwak, Ji-Young;Lee, Jae-Hwang;Park, Yong-Chjun;Jo, Tae-Yong;Lee, Hwa-Jung;Lee, Sang-Jae;Han, Sang-Bae
    • Journal of Radiation Industry
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    • v.7 no.1
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    • pp.69-74
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    • 2013
  • This study examined radiation detection characteristics of spices (cumin, caper and turmeric), other small fruits (hut-gae berry and boxthorn), and pollen extract product. Each samples were irradiated at dose of 1, 5, and 10 kGy and analyzed by the thermoluminescence (TL) and electron spin resonance (ESR) methods. To compare between non-irradiated and irradiated food, all samples were irradiated with $^{60}Co$ gamma-ray source. In TL analysis, most of samples could be applied to detect irradiated foods because of showing TL ratio above 0.1. The glow curves examined by TL method were estimated in the range of $150{\sim}250^{\circ}C$ in irradiated samples. In ESR measurements, the intensity of ESR signal (single-line) increased as the increase of irradiation dose. In particular, the specific ESR signals of irradiation-induced radical were detected in hut-gae berry and pollen extract product. As a results, it is considered that TL and ESR methods can be used to detect both hut-gae berry and pollen extract product. But cumin, caper, turmeric and boxthorn irradiated with gamma ray could be detected only by TL method. It is concluded that TL and ESR methods are suitable for detection of irradiated samples and a combined method is recommendable for enhancing the reliability of detection results.

New in vitro multiple cardiac ion channel screening system for preclinical Torsades de Pointes risk prediction under the Comprehensive in vitro Proarrhythmia Assay concepta

  • Jin Ryeol An;Seo-Yeong Mun;In Kyo Jung;Kwan Soo Kim;Chan Hyeok Kwon;Sun Ok Choi;Won Sun Park
    • The Korean Journal of Physiology and Pharmacology
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    • v.27 no.3
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    • pp.267-275
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    • 2023
  • Cardiotoxicity, particularly drug-induced Torsades de Pointes (TdP), is a concern in drug safety assessment. The recent establishment of human induced pluripotent stem cell-derived cardiomyocytes (human iPSC-CMs) has become an attractive human-based platform for predicting cardiotoxicity. Moreover, electrophysiological assessment of multiple cardiac ion channel blocks is emerging as an important parameter to recapitulate proarrhythmic cardiotoxicity. Therefore, we aimed to establish a novel in vitro multiple cardiac ion channel screening-based method using human iPSC-CMs to predict the drug-induced arrhythmogenic risk. To explain the cellular mechanisms underlying the cardiotoxicity of three representative TdP high- (sotalol), intermediate- (chlorpromazine), and low-risk (mexiletine) drugs, and their effects on the cardiac action potential (AP) waveform and voltage-gated ion channels were explored using human iPSC-CMs. In a proof-of-principle experiment, we investigated the effects of cardioactive channel inhibitors on the electrophysiological profile of human iPSC-CMs before evaluating the cardiotoxicity of these drugs. In human iPSC-CMs, sotalol prolonged the AP duration and reduced the total amplitude (TA) via selective inhibition of IKr and INa currents, which are associated with an increased risk of ventricular tachycardia TdP. In contrast, chlorpromazine did not affect the TA; however, it slightly increased AP duration via balanced inhibition of IKr and ICa currents. Moreover, mexiletine did not affect the TA, yet slightly reduced the AP duration via dominant inhibition of ICa currents, which are associated with a decreased risk of ventricular tachycardia TdP. Based on these results, we suggest that human iPSC-CMs can be extended to other preclinical protocols and can supplement drug safety assessments.

An evaluation scenario of safety performance for extraordinary service permission of autonomous vehicle (자율주행 자동차 임시운행 허가를 위한 안전 성능 평가 시나리오)

  • Jeong, Yonghwan;Yi, Kyongsu;Choi, In Seong;Min, Kyong Chan
    • Journal of Auto-vehicle Safety Association
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    • v.7 no.2
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    • pp.44-49
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    • 2015
  • This paper presents an evaluation scenario of safety performance for extraordinary service permission of autonomous vehicle driving on a motorway. Based on advanced driver assistance system (ADAS) which is already mass-production, an autonomous vehicle driving on motorway is tested on the public roads and also getting close to mass-production. Before the autonomous vehicle tested, the safety of autonomous driving system should be evaluated based on a proper test scenario. Prior to develop the test scenario, this paper reviews the licensing standards for an autonomous vehicle in California and Nevada, and the international regulations of each ADAS. To develop the scenario, the driving conditions of motorway are categorized into five modes and fundamental evaluation requirements of elements of autonomous driving system are derived. An evaluation scenario, which represents the real driving conditions, has been developed to assess the safety of autonomous vehicle. This scenario has validated by computer simulation using model predictive control (MPC) based autonomous driving algorithm.