• Title/Summary/Keyword: Safety evaluation test

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Development of Dissolution Test Method for Acebrophylline Capsules and Bromhexine Hydrochloride Tablets in Korean Pharmaceutical Codex (고시수재 의약품 중 아세브로필린 캡슐 및 브롬헥신염산염 정의 용출시험법 개발)

  • Lee, Tae-Woong;Jeong, Rae-Seok;Jeong, Seung-A;Kim, Jeong-Hyun;Shim, Young-Hun;Kim, In-Kyu;Park, Chang-Won
    • YAKHAK HOEJI
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    • v.57 no.3
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    • pp.226-233
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    • 2013
  • Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specification in Korean Pharmaceutical Codex (KPC). So, with each reference and test drugs, the dissolution test method and an analytical procedure by HPLC were developed and validated to establish dissolution specification for acebrophylline capsules and bromhexine hydrochloride tablets. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Ministry of Food and Drug Safety (MFDS). The analytical method of HPLC was validated in specificity, linearity, precision and accuracy. Final dissolution test was performed with commercially available samples of 3 lots to establish specification. In addition, no difference was observed by the inter-laboratory evaluation. Dissolution specifications and conditions will be used for revising the monograph of acebrophylline capsules and bromhexine hydrochloride tablets in next supplement of KPC.

Development and Validation of Safety Performance Evaluation Scenarios of Autonomous Vehicle based on Driving Data (주행데이터 기반 자율주행 안전성 평가 시나리오 개발 및 검증)

  • Lim, Hyeongho;Chae, Heungseok;Lee, Myungsu;Lee, Kyongsu
    • Journal of Auto-vehicle Safety Association
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    • v.9 no.4
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    • pp.7-13
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    • 2017
  • As automotive industry develops, the demand for increasing traffic safety is growing. Lots of researches about vehicle convenience and safety technology have been implemented. Now, the autonomous driving test is being conducted all over the world, and the autonomous driving regulations are also being developed. Autonomous vehicles are being commercialized, but autonomous vehicle safety has not been guaranteed yet. This paper presents scenarios that assess the safety of autonomous vehicles by identifying the minimum requirements to ensure safety for a variety of situations on highway. In assessing driving safety, seven scenarios were totally selected. Seven scenarios were related to lane keeping and lane change performance in certain situations. These scenarios were verified by analyzing the driving data acquired through actual vehicle driving. Data analysis was implemented via computer simulation. These scenarios are developed based on existing ADAS evaluation and simulation of autonomous vehicle algorithm. Also Safety evaluation factors are developed based on ISO requirements, other papers and the current traffic regulations.

Determination and Validation of an Analytical Method for Dichlobentiazox in Agricultural Products with LC-MS/MS (LC-MS/MS를 이용한 농산물 중 Dichlobentiazox 시험법 개발 및 검증)

  • Gu, Sun Young;Lee, Han Sol;Park, Ji-Su;Lee, Su Jung;Shin, Hye-Sun;Kang, Sung Eun;Chung, Yun Mi;Choi, Ha Na;Yoon, Sang Soon;Jung, Young-Hyun;Yoon, Hae Jung
    • Korean Journal of Environmental Agriculture
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    • v.40 no.2
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    • pp.108-117
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    • 2021
  • BACKGROUND: Dichlobentiazox is a newly registered pesticide in Korea as a triazole fungicide and requires establishment of an official analysis method for the safety management. Therefore, the aim of this study was to determine the residual analysis method of dichlobentiazox for the five representative agricultural products. METHODS AND RESULTS: Three QuEChERS methods were applied to establish the extraction method, and the EN method was finally selected through the recovery test. In addition, various adsorbent agents were applied to establish the clean-up method. As a result, it was found that the recovery of the tested pesticide was reduced when using the d-SPE method with PSA and GCB, but C18 showed an excellent recovery. Therefore this method was established as the final analysis method. For the analysis, LC-MS/MS was used with consideration of the selectivity and sensitivity of the target pesticide and was operated in MRM mode. The results of the recovery test using the established analysis method and inter laboratory validation showed a valid range of 70-120%, with standard deviation and coefficient of variation of less than 3.0% and 11.6%, respectively. CONCLUSION: Dichlobentiazox could be analyzed with a modified QuEChERS method, and the method determined would be widely available to ensure the safety of residual pesticides in Korea.

The Evaluation on the Durability and Safety of Fuel Cyliders for CNG Buses (CNG 버스용 연료용기의 내구안전성 평가)

  • Park, Yong-Hwan
    • Journal of the Korean Society of Safety
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    • v.19 no.1
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    • pp.6-11
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    • 2004
  • CNG buses were introduced in 2002 to reduce air pollution to the big cities. The durability and safety evaluation were performed for the NGV-2 type cylinders taken from two buses after 30 months of running. No external damage and no internal corrosion was observed on the container surfaces. Defect exceeding the allowable limit was not found in the UT test. Permanent volume expansion was about 1.2% which is much smaller than the required design limit. Cycling test showed no failure after 11,250cycles and burst pressures were still above the maximum design pressure. Both the longitudinal and circumferential failure mode were observed, where both the fracture strengths were far above the design limit. This study showed the present CNG fuel cylinders were safe enough for further usage.

A Study on Proposal of Facility Standard by Research of Safety Accidents at Elderly Housing Welfare Facility (노인주거 복지시설 안전사고 실태조사에 의한 시설기준 제안에 관한 연구)

  • You, Jong-Ok;Park, Jae-Seung
    • Journal of The Korea Institute of Healthcare Architecture
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    • v.17 no.2
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    • pp.7-16
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    • 2011
  • The death toll of the elderly by accidents in 2007 takes 6.5% of total death toll. The lost income from this is estimated to be 17 trillion and 511 billion won. According to CISS of Korea Consumer Protection Board, the number of safety related accidents of the elderly at home in 2006 was 486 cases in 2006 and has gradually increased every year. This thesis created 115 guidelines at 14 spaces as facility evaluation index evaluating the aging friendliness of the facility and safety related accidents generated at elderly resident welfare facility, examined influence variables of safety related accidents with 191 elderly including demographic variable, physical skill variable, social psychological variable and facility environmental variables, and then verified relevance between safety accidents and each influence variable. As a result, it was verified through ANOVA test of SAS Package Program and $x^2$- test that facility environmental variable would be closely related to the accident. In this regard, this study newly proposes the facility standards of aging friendly facility by supplementing them with contents and guidelines of facility evaluation table as ways to reduce safety related facility of the elderly.

The Intrinsic Safety Evaluation of Solar Photovoltaic Cell (태양전지셀의 본질안전 방폭성능 평가)

  • Lee, Chun-Ha;Jee, Seung-Wook;Kim, Si-Kuk
    • Journal of the Korean Institute of Illuminating and Electrical Installation Engineers
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    • v.25 no.7
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    • pp.49-54
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    • 2011
  • Now the world will regulate the CO2 emission due to environmental issues. For an alternative plan photovoltaic system is watched. So, photovoltaic system is trend of big city and it is mandatory for renovation of construction. Oil & gas filling station existed in city is suitable to found the photovoltaic system. But the general photovoltaic system in oil & gas filling station is difficult to found because it is classified into hazardous area. This paper evaluates intrinsic safety evaluation of solar cell for making basic data to found for the photovoltaic system on hazardous area. The intrinsic safety characteristic is evaluated by short-circuit ignition test using IEC type spark ignition test apparatus and temperature rising test. The result of short-circuit ignition test, propane-air mixture gas is exploded on condition that 4 solar cells(9[V], 90[mA]) are connected serially under insolation 800[W/$m^2$]. So, if a larger solar module will be used at oil & gas filling station than we were tested, it needs explosion proof. As the result of rising temperature test, the temperature rising due to short circuit is not so much, but when the temperature rises due to radiant heat, it demands careful consideration for environmental influence.

Development of a New Approach to Determine the Potency of Bacille Calmette-Guérin Vaccines Using Flow Cytometry

  • Gweon, Eunjeong;Choi, Chanwoong;Kim, Jaeok;Kim, Byungkuk;Kang, Hyunkyung;Park, Taejun;Ban, Sangja;Bae, Minseok;Park, Sangjin;Jeong, Jayoung
    • Osong Public Health and Research Perspectives
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    • v.8 no.6
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    • pp.389-396
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    • 2017
  • Objectives: To circumvent the limitations of the current golden standard method, colony-forming unit (CFU) assay, for viability of Bacille Calmette-$Gu{\acute{e}}rin$ (BCG) vaccines, we developed a new method to rapidly and accurately determine the potency of BCG vaccines. Methods: Based on flow cytometry (FACS) and fluorescein diacetate (FDA) as the most appropriate fluorescent staining reagent, 17 lots of BCG vaccines for percutaneous administration and 5 lots of BCG vaccines for intradermal administration were analyzed in this study. The percentage of viable cells measured by flow cytometry along with the total number of organisms in BCG vaccines, as determined on a cell counter, was used to quantify the number of viable cells. Results: Pearson correlation coefficients of FACS and CFU assays for percutaneous and intradermal BCG vaccines were 0.6962 and 0.7428, respectively, indicating a high correlation. The coefficient of variation value of the FACS assay was less than 7%, which was 11 times lower than that of the CFU assay. Conclusion: This study contributes to the evaluation of new potency test method for FACS-based determination of viable cells in BCG vaccines. Accordingly, quality control of BCG vaccines can be significantly improved.

Neurotoxicity of Synthetic Cannabinoids JWH-081 and JWH-210

  • Cha, Hye Jin;Seong, Yeon-Hee;Song, Min-Ji;Jeong, Ho-Sang;Shin, Jisoon;Yun, Jaesuk;Han, Kyoungmoon;Kim, Young-Hoon;Kang, Hoil;Kim, Hyoung Soo
    • Biomolecules & Therapeutics
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    • v.23 no.6
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    • pp.597-603
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    • 2015
  • Synthetic cannabinoids JWH-018 and JWH-250 in 'herbal incense' also called 'spice' were first introduced in many countries. Numerous synthetic cannabinoids with similar chemical structures emerged simultaneously and suddenly. Currently there are not sufficient data on their adverse effects including neurotoxicity. There are only anecdotal reports that suggest their toxicity. In the present study, we evaluated the neurotoxicity of two synthetic cannabinoids (JWH-081 and JWH-210) through observation of various behavioral changes and analysis of histopathological changes using experimental mice with various doses (0.1, 1, 5 mg/kg). In functional observation battery (FOB) test, animals treated with 5 mg/kg of JWH-081 or JWH-210 showed traction and tremor. Their locomotor activities and rotarod retention time were significantly (p<0.05) decreased. However, no significant change was observed in learning or memory function. In histopathological analysis, neural cells of the animals treated with the high dose (5 mg/kg) of JWH-081 or JWH-210 showed distorted nuclei and nucleus membranes in the core shell of nucleus accumbens, suggesting neurotoxicity. Our results suggest that JWH-081 and JWH-210 may be neurotoxic substances through changing neuronal cell damages, especially in the core shell part of nucleus accumbens. To confirm our findings, further studies are needed in the future.

Development of Evaluation Programs for Adaptive Cruise Control System (ACC(Adaptive Cruise Control) 평가프로그램 개발)

  • Moon Young-Jun;Park Yukyung
    • The Journal of The Korea Institute of Intelligent Transport Systems
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    • v.1 no.1
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    • pp.70-78
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    • 2002
  • Advanced safety vehicle (ASV) equipped with intelligent drivers advisory functions for controlling vehicle to follow the lead vehicle and/or warning drivers on forward traffic impediments according to the roadway and traffic circumstances has been recently developed and on the market internationally. Standardization processes for ASV system functions have been issued in IS0/TC204 Working Group 14 (Vehicle/Roadway Warning and Control System) since 1995. Research projects developing test and evaluation technologies for ASV in establishing safety standards and/or conformity related to the national roadway and traffic circumstances are under study internationally. In Korea, an integrated test and evaluation Program was developed for the assessment of adaptive cruise control (ACC) system under the ITS research and development projects funded by the Ministry of Construction and Transportation (MOCT). This paper demonstrates the integrated test and evaluation Programs for ACC system based on the draft international standard with related to the domestic roadway and traffic conditions. Field tests fulfilled under the scenarios based on the integrated test & evaluation programs for ACC system are discussed along with a review of earlier research work regarding international standards and the safety regulations.

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