• 제목/요약/키워드: Impact Safety

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경구용 속방성 성형제품의 허가 후 변경사항을 다루는 SUPAC-IR에 대한 검토 (Scrutiny Made to SUPAC-IR Dealing with Postapproval Changes in Immediate Release Sold Oral Dosage Forms)

  • 사홍기;박상애;윤미옥;강신정
    • Journal of Pharmaceutical Investigation
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    • 제34권1호
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    • pp.57-71
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    • 2004
  • The objective of this study was to provide a better understanding of SUPAC-IR and its application in handling postapproval changes to immediate release solid oral dosage forms. Originally, SUPAC-IR was aimed at reducing the regulator burdern of the industry when they were making postapproval changes, but still at maintaining the formulation quality and performance of a drug product. The postapproval changes that were covered under SUPAC-IR included variations in the components ad composition of formulation, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. The guidance defined levels of changes, based on the likelihood of risk ocurrence and potential impact of postapproval changes upon the safety and efficacy of a drug product I suggested what a type of fing report should be submitted to the FDA for each level of change. Chemist, manufacturing, and control tests to be executed were also recommended for each change level The important tests specified in the guidance included batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. However, there have been strong demands on revising the current SUPAC-IR in order to resolve some issues and to improve its usefulness in evaluating postapproval changes to immediate release solid oral dosage forms. In particular, the rigorous requirement of case C dissolution test and the definition of batch size were challenged by both academia and the industry. A revision work was in progress to reflect these inputs and to expand the utility of SUPAC-IR. As a result of these concerted efforts, an updated 2nd version of SPAC-IR would be likely to be issued ver soon to the public.

Dietary inclusion effects of phytochemicals as growth promoters in animal production

  • Valenzuela-Grijalva, Nidia Vanessa;Pinelli-Saavedra, Araceli;Muhlia-Almazan, Adriana;Dominguez-Diaz, David;Gonzalez-Rios, Humberto
    • Journal of Animal Science and Technology
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    • 제59권4호
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    • pp.8.1-8.17
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    • 2017
  • Growth promoters have been widely used as a strategy to improve productivity, and great benefits have been observed throughout the meat production chain. However, the prohibition of growth promoters in several countries, as well as consumer rejection, has led industry and the academy to search for alternatives. For decades, the inclusion of phytochemicals in animal feed has been proposed as a replacement for traditional growth promoters. However, there are many concerns about the application of phytochemicals and their impact on the various links in the meat production chain (productive performance, carcass and meat quality). Therefore, the effects of these feed additives are reviewed in this article, along with their potential safety and consumer benefits, to understand the current state of their use. In summary, the replacement of traditional growth promoters in experiments with broilers yielded benefits in all aspects of the meat production chain, such as improvements in productive performance and carcass and meat quality. Although the effects in pigs have been similar to those observed in broilers, fewer studies have been carried out in pigs, and there is a need to define the types of phytochemicals to be used and the appropriate stages for adding such compounds. In regard to ruminant diets, few studies have been conducted, and their results have been inconclusive. Therefore, it is necessary to propose more in vivo studies to determine other strategies for phytochemical inclusion in the production phases and to select the appropriate types of compounds. It is also necessary to define the variables that will best elucidate the mechanism(s) of action that will enable the future replacement of synthetic growth promoters with phytochemical feed additives.

IMF시대의 식생활 소비패턴에 관한 연구 (A Study on the Consumption Patterns of Food Life in IMF Age)

  • 이진영;이혜임
    • 한국식생활문화학회지
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    • 제14권4호
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    • pp.333-352
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    • 1999
  • This study investigates the impact of International Monetary Fund(IMF) Age on the household behavior of food consumption and analysis the related factors(demographic variables, family life style) to find out the reasonable consumer's consciousness and food market conditions. The results are as follows. 1. General life style and food life style, considered as family life style, were classified into 7 types and 9 types respectively as family life style by factor analysis. 2. The rationality of using and disposing stage on food life has increased, the rationality of the planning stage on food life has decreased since the IMF age began. But the rationality of overall food consumption has hardly changed. 3. The amount of purchasing was decreased, discount store was favorite place to buy food, and safety and freshness were major determinants in purchasing for most of food items. But this was different with food items. The various information sources were used impartially to buy food, cash was used mainly, and the degree of using the discount ticket/coupon was a little low. 4. Income level is an influential factor on the rationality of the planning and purchasing stage on food life, while environment-oriented food life style has influenced on the rationality of using and disposing stage. The purchasing amount of grain products, meats, milk products, bread and snacks, drinks, alcoholic drinks, water and convenience goods has influenced by demographic variables, eating out had been influenced by general life styles, and fruits, healthy foods, processed foodstuffs, favorite foods, vegetables seaweeds, import foods and seafood had been mainly influenced by food life style since IMF age began.

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다구찌 설계법을 이용한 주름댐퍼를 갖는 헬멧안전의 감쇠효과에 관한 연구 (On the Damping Effects of Helmet Safety with a Corrugation Damper using Taguchi's Optimization Design)

  • 김청균
    • 한국가스학회지
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    • 제12권4호
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    • pp.34-40
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    • 2008
  • FEM과 다구찌의 설계기법을 이용하여 헬멧의 주름댐퍼에 걸리는 수직방향 변위량, von Mises 응력, 변형률 에너지를 주름댐퍼의 돌출길이와 두께, 주름댐퍼의 상단코너반경과 하단코너반경의 함수로 각각 분석하였다. 주름댐퍼의 형상에 대한 최적의 설계요소는 헬멧에 전달되는 외부의 충격력에 의해 형성되는 충격에너지를 흡수할 수 있는 감쇠용량, 즉 변형률 에너지를 높여줄 수 있다는 측면에서 대단히 중요하다. 본 연구에서 다구찌 설계법에 기반한 최적설계는 주름댐퍼의 돌출길이 L = 20 mm, 두께 t = 2 mm, 상단코너반경 $R_1=4\;mm$, 하단코너반경 $R_2=3\;mm$로 계산되었다. 주름댐퍼의 설계에 가장 큰 영향을 미치는 핵심요소는 주름댐퍼의 두께와 돌출길이고, 이들 설계요소는 헬멧의 충격에너지 흡수용량을 나타내는 변형률 에너지 증가에 대한 기여도가 높다.

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Micromechanical investigation for the probabilistic behavior of unsaturated concrete

  • Chen, Qing;Zhu, Zhiyuan;Liu, Fang;Li, Haoxin;Jiang, Zhengwu
    • Computers and Concrete
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    • 제26권2호
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    • pp.127-136
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    • 2020
  • There is an inherent randomness for concrete microstructure even with the same manufacturing process. Meanwhile, the concrete material under the aqueous environment is usually not fully saturated by water. This study aimed to develop a stochastic micromechanical framework to investigate the probabilistic behavior of the unsaturated concrete from microscale level. The material is represented as a multiphase composite composed of the water, the pores and the intrinsic concrete (made up by the mortar, the coarse aggregates and their interfaces). The differential scheme based two-level micromechanical homogenization scheme is presented to quantitatively predict the concrete's effective properties. By modeling the volume fractions and properties of the constituents as stochastic, we extend the deterministic framework to stochastic to incorporate the material's inherent randomness. Monte Carlo simulations are adopted to reach the different order moments of the effective properties. A distribution-free method is employed to get the unbiased probability density function based on the maximum entropy principle. Numerical examples including limited experimental validations, comparisons with existing micromechanical models, commonly used probability density functions and the direct Monte Carlo simulations indicate that the proposed models provide an accurate and computationally efficient framework in characterizing the material's effective properties. Finally, the effects of the saturation degrees and the pore shapes on the concrete macroscopic probabilistic behaviors are investigated based on our proposed stochastic micromechanical framework.

수치표고모형 (DEM)을 이용한 침수재해 지도작성에 관한 연구 (A Study on Making Map of Flood Using Digital Elevation Model (DEM))

  • 임현택;김재휘;이학범;박성용;김용성
    • 한국농공학회논문집
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    • 제59권2호
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    • pp.81-90
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    • 2017
  • Recent floodplain data are important for river master plan, storm and flood damage reduction comprehensive plan and pre-disaster impact assessment. Hazard map, base of floodplain data, is being emphasized as important method of non-structural flood prevention and consist of inundation trace map, inundation expected map and hazard information map. Inundation trace map describes distribution of area that damaged from typhoons, heavy rain and tsunamis and includes identified flood level, flood depth and flood time from flooding area. However due to lack of these data by local government, which are foundational and supposed to be well prepared nationwide, having hard time for making inundation trace map or hazard information map. To overcome this problem, time consumption and budget reduction is required through various research. From this study, DEM (Digital Elevation Model) from image material from UAVS (Unmanned Aerial Vehicle System) and numeric geographic map from National Geographic Information Institute are used for calculating flooding damaged area and compared with inundation trace map. As results, inundation trace map DEM based on image material from UAVS had better accuracy than that used DEM based on numeric geographic map. And making hazard map could be easier and more accurate by utilizing image material from UAVS than before.

주단위 표준강수증발산지수를 활용한 2014~2015년 북한의 극한 가뭄 평가 (Assessment of the Extreme 2014~2015 Drought Events in North Korea Using Weekly Standardized Precipitation Evapotranspiration Index (SPEI))

  • 남원호;홍은미;최진용;김태곤
    • 한국농공학회논문집
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    • 제59권4호
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    • pp.65-74
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    • 2017
  • North Korea is one of the high vulnerable countries facing the threat of natural disaster and has experienced more frequent disasters in recent years. These disasters have significantly led to food shortages and large reductions in crop yields. In 2015, both North Korean officials and international agencies had identified the extreme drought event, the worst in one hundred years according to the North Korean government. The objective of this study was an assessment of the extreme drought events in 2014~2015, and to apply climatic drought indices for drought monitoring in North Korea. Characteristics of the extreme drought in North Korea are examined by using the weekly-based Standardized Precipitation Evapotranspiration Index (SPEI). The drought characteristics illustrated by the SPEI results are compared with a Standardized Precipitation Index (SPI) results and drought impact information to understand how these indices can explain the drought conditions within the country. These results demonstrated that the SPEI could be an effective tool to provide improved spatial and temporal drought conditions to inform management decisions for drought policy.

Dry aging of beef; Review

  • Dashdorj, Dashmaa;Tripathi, Vinay Kumar;Cho, Soohyun;Kim, Younghoon;Hwang, Inho
    • Journal of Animal Science and Technology
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    • 제58권5호
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    • pp.20.1-20.11
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    • 2016
  • The present review has mainly focused on the specific parameters including aging (aging days, temperature, relative humidity, and air flow), eating quality (flavor, tenderness and juiciness), microbiological quality and economic (shrinkage, retail yields and cost) involved beef dry aging process. Dry aging is the process where beef carcasses or primal cuts are hanged and aged for 28 to 55 d under controlling environment conditions in a refrigerated room with $0^{\circ}$ to $4^{\circ}C$ and with relative humidity of 75 to 80 %. However there are various opinions on dry aging procedures and purveyors of such products are passionate about their programs. Recently, there has been an increased interest in dry aging process by a wider array of purveyors and retailers in the many countries. Dry aging process is very costly because of high aging shrinkage (6 to 15 %), trims loss (3 to 24 %), risk of contamination and the requirement of highest grades meat with. The packaging in highly moisture-permeable bag may positively impact on safety, quality and shelf stability of dry aged beef. The key effect of dry aging is the concentration of the flavor that can only be described as "dry-aged beef". But the contribution of flavor compounds of proteolysis and lipolysis to the cooked dry aged beef flavor is not fully known. Also there are limited scientific studies of aging parameters on the quality and palatability of dry aged beef.

시트 백 프레임의 형상에 따른 구조 해석에 관한 연구 (Study on Structural Analysis due to Configuration of Seat Back Frame)

  • 김성수;최해규;최두석;김세환;오범석;조재웅;국정한
    • 한국산학기술학회논문지
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    • 제13권3호
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    • pp.994-1001
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    • 2012
  • 승차감이나 안전에 관련된 부분 중 하나인 자동차 시트는 차량 주행시 전달되는 충격이나 진동을 적절하게 흡수하여 승객에게 안락성을 제공한다. 또한 이러한 여건을 만족시키면서 승객의 안전을 보장하는 충분한 강성과 강도를 가져야 한다. 자동차 시트는 2가지의 모델로 설계를 하고 구조 해석을 하였다. 그 결과, 시트 백 프레임의 모델(b)가 (a)보다 적은 변형량과 피로 수명을 보였고. 모델의 중앙에 해당되는 허리부분에서 가장 많은 변형량과 파손 가능성을 보였다. 고유진동수를 적용한 진동해석에서, 모델(a)의 경우는 모델의 바깥쪽에서 안쪽으로 변형이 되었고, 모델(b)의 경우는 모델의 안쪽에서 바깥쪽으로 변형이 되었다. 전반적으로 모든 면에서 모델(b)가 (a)보다 구조적으로 안전하다고 사료된다.

미생물제제의 해상유출유 분해 효과에 대한 연구 (A Study of the Effectiveness of Bioremediation Agents to degrade the spilled oils on waters)

  • 임재동;윤종휘;김인수
    • 해양환경안전학회:학술대회논문집
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    • 해양환경안전학회 2004년도 춘계학술발표회
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    • pp.73-79
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    • 2004
  • 해상에서의 대형 유류유출 사고 발생으로 인한 유류오염은 해양 생태계에 치명적인 영향을 미치게 되극 최종적으로는 인간에게 심각한 위험을 초래하게 된다. 따라서 해안을 접한 많은 나라들은 방제기술 향상을 위한 많은 노력을 하고 있다. 미생물제제를 이용한 유류 제거는 몇몇 국가에서 2차적인 방제방법이나 다른 방제 방법의 대안으로 제한적으로 사용하고 있다. 본 논문에서는 향후 유류사고 발생시 적용을 위해 미생물제제의 분해 효과와 영향을 실험실 규모의 실험을 통해 찾아보았다. 본 논문에서 유출유에 대한 미생물제제의 효과와 효율은 단기적으로 실험실에서 행해진 실험의 결과이므로 실제와는 많은 차이가 있다는 것을 염두에 두고 차후에는 장기적인 현장실험을 통한 미생물 제제를 이용한 유출유의 방제 가능성을 찾아보아야 할 것이다.

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