• Title/Summary/Keyword: TR test

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Characterization of Test Substance in the GLP (GLP 시험에서의 시험물질 특성파악)

  • Lee, Eun-Jung;Song, Kyung-Seuk;Yu, Il-Je
    • Toxicological Research
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    • v.23 no.2
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    • pp.173-177
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    • 2007
  • The GLP contains specific language concerning characterization of the test, control and reference substances used in toxicity studies. This paper will describe and discuss what types of documents are required to support test/reference substance characterization under GLP system. The purpose of this article is to present an overview of data needed in the characterization package that will adequately define the substance. Most sponsors use a certificate of analysis (COA) to communicate the test sub-stance characterization status information to the contracting research organizations. The COA should provide the test $material^{\circ}{\phi}s$ characterization results, substance storage requirements, expiration dates, verification of the collection of the retention sample, archival location of the data to support the characterization and GLP compliance status of the characterization.

Lifetime test of batteries for BLE modules for site identification of vessel's crews and passengers (SIVCP) (SIVCP용 BLE 모듈의 배터리 수명시험)

  • Kwon, Hyuk-joo;Kim, Min-Gwon;Kim, Yoon-Sik;Lee, Sung-Geun
    • Journal of Advanced Marine Engineering and Technology
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    • v.39 no.7
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    • pp.754-759
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    • 2015
  • Nowadays, short distance communication systems with low power energy (LPE) are developed for identification and monitoring of site identification of vessel crews and passengers (SIVCP). LPE communication modules, such as Bluetooth low energy (BLE) and Zigbee, are used for short distance communications with LPE. These modules enable 1:N communications and their popularity is growing since the modules can be mounted on movable objects, such as mobile devices and human body. When these modules are used, the important factor that affects their operation time and design are the capacity and size of battery. Therefore, they must be made as small as possible, and the battery should be selected to be slightly smaller than the module. In this study, we calculate the theoretical life of batteries used in SIVCP BLE modules using data sheet and discharge characteristic graph under the condition of a 1/250 transmission-ratio (TR). We thus calculate experimental life by measuring transmission current for the same TR, and low speed mode current for a 1/5000 TR and measure long-term experimental life using 1/25 TR for days. Through these experiments, we verify experimental methods for the prediction and extension of battery life that would enable us to select appropriate sizes of batteries based on vessel usage and passenger types. The selections of the module TR and battery size are important factors affecting the cost reduction of module design, the battery maintenance, and passenger convenience.

A New Way in Deciding NOAEL Based on the Findings from GLP-Toxicity Test

  • Park, Yeong-Chul;Cho, Myung-Haing
    • Toxicological Research
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    • v.27 no.3
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    • pp.133-135
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    • 2011
  • The FDA guidance focuses on the use of the NOAEL to establish the maximum recommended starting dose. The majority of NOAEL has been described inaccurately or incompletely in final reports for 90-days repeated dose toxicity test based on GLP (good laboratory practice) regulation. This is the most serious one of reasons for why most pharmaceutical companies targeting global markets have disregarded the final report produced from GLP facilities in Korea. The problems in deciding NOAEL reflected in the final reports are mainly due to the followings; 1) Inaccurate description or use of NOEL, NOAEL and LOAEL, 2) Insufficient and inappropriate interpretations in findings from toxicity test. This paper is intended to provide the insight into distinguishing NOAEL from NOEL and LOAEL, and into classifying findings from toxicity test. Here, the three step method is newly suggested by applying the weight-based classification to the NOEL, NOAEL and LOAEL based on the findings.

Usefulness of the High B-value DWI in Brain Tumors (뇌종양 확산강조영상에서 High B-value의 유용성 평가)

  • Kim, Jin-tae;Byun, Jae-Hu;Park, Yong-Seong;Lee, Rae-Gon;Hwang, Seon-Kwang
    • Korean Journal of Digital Imaging in Medicine
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    • v.17 no.1
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    • pp.33-41
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    • 2015
  • This study attempts to examine the clinical usefulness of High b-value DWI (diffusion weighted imaging) for brain tumors with an edema. Subjects were seven patients selected from 65 patients who received an MRI scan for suspected encephalopathy and confirmed diagnosis at our hospital from February to July 2015 (male: 7, average age : 66 years old). As test equipment, 3.0T MR System (ACHIEVA Release, Philips, Best, The Netherlands) and 8Channel SENSE Head Coill were used. DWI checks on the use of the variable TR 5460ms, TE 132ms, Slice Thickness 4mm, gap 1mm, Slice number 29 is, 3D T1WI is TR 8.4ms, TE 3.9ms, matrix size $240{\times}240$, Slice can set 180 piecesIt was. b value of 0, 1,000, 2,000 s/mm2 with DWI acquisition and 3D T1WI enhancement five minutes after the Slice Thickness 3mm, gap 0mm to reconstruct the upper face axis (MPR TRA CE) was. As for the experiment, in b-value 1,000 and 2,000 images, SNR and the lesion at the lesion site and CNR in the normal site opposite to the lesion are measured. WW(window width) and WL(window level) are made equal in MRICro software, and the volume of the lesion is measured from each of b-value and MPR TRA CE image. Using SPSS ver. 1.8.0.0 Mann Whitney-test was analyzed for SNR and CNR, while Kruskal-Wallis test was analyzed for volume.

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Effect of the Balance Exercise on the Unstable Surfaces for the Vital Capacity in Healthy Adults: A Preliminary Study (불안정한 지지면에서의 균형운동이 건강한 성인의 폐활량에 미치는 효과: 사전 연구)

  • Kim, Taeho;Park, Hankyu
    • Journal of The Korean Society of Integrative Medicine
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    • v.4 no.3
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    • pp.17-25
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    • 2016
  • Purpose : This study attempts to examine the effect of the balance exercise on the unstable surfaces for the vital capacity in healthy adults. Methods : A total of 13 subjects was randomly divided into a breathing exercise training group (n=7) and a breathing and balance exercise training group (n=6). Changes in vital capacity and respiratory muscle activity were measured before and after the intervention. The intervention was performed three times a week for four weeks. Forced vital capacity (FVC), forced expiratory volume at one second (FEV1) and maximal voluntary ventilation (MVV) were used as measurement tools for the vital capacity test. Electromyography (EMG) was also used to examine respiratory muscle activity. Result : The breathing exercise training group showed significant improvement in terms of FVC, FEV1 and external oblique (EO), and transverse abdominis/internal oblique (TrA/IO) of MVV. The breathing and balance exercise training group showed significant improvement in terms of FVC, MVV and EO, TrA/IO of FVC and rectus abdominis (RA), EO, and TrA/IO of MVV. However, in comparing changes in vital capacity and respiratory muscle activity before and after the training, the breathing exercise training group and the breathing and balance exercise training group showed a significant difference in terms of MVV. Conclusion : This study is as a preliminary study to find out the relation between a balance exercise and a vital capacity, it is considered to require a further study with several revisions of subjects, duration and time for an intervention.

Reliability and validity of a personal computer based muscle viewer for measuring upper trapezius and transverses abdominis muscle thickness

  • Jeong, Ju-Ri;Han, Ju Hee;Cho, Ji-Eun;Lee, Wan-hee
    • Physical Therapy Rehabilitation Science
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    • v.5 no.3
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    • pp.155-161
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    • 2016
  • Objective: This study aimed to investigate the reliability and validity of a personal computer-based muscle viewer (PC-BMW) compared with that of a portable ultrasound (P-US) for measuring upper trapezius (UT) and transversus abdominis (TrA) muscle thickness at rest and during contraction. Design: Observational inter-rater reliability study. Methods: Fifty-five healthy participants (25 men, 30 women) participated in this study. PC-BMW and P-US were randomly measured at the UT and TrA muscles. Two examiners randomly obtained the images of all participants in 3 test sessions lasting 2 days. Intra-class correlation coefficients (ICCs), standard error of measurement, contraction ratio, and correlation were used to estimate reliability and validity. Pearson's correlation coefficients were used to analyze the relationship between muscle thickness measures taken from PC-BMW and P-US. Results: The intra-rater reliability ICCs of UT and TrA muscle thickness for the PC-BMW were >0.995, indicating excellent reliability. Inter-rater reliability ICCs for the PC-BMW ranged from 0.963 to 0.987. The P-US also exhibited high reliability. A high correlation was found between the measurements of the two muscles in PC-BMW and P-US (p<0.01). Conclusions: PC-BMW provides clear and excellent images, is pocket-sized and less expensive than a conventional ultrasound imaging system. PC-BMW can be utilized variously and has the advantage of rehabilitative ultrasound imaging. More research is needed to evaluate the utility of PC-BMW for rehabilitation.

Focal Lesion Detection of SPIO-specific agent Compared with Optimized Pulse Sequences in the Hepatic Metastases: Case Review (간 전이환자에서 최적의 펄스시퀀스에 따른 SPIO 특이성 조영제의 국소병변검출: Case review)

  • Goo, Eun-Hoe
    • Korean Journal of Digital Imaging in Medicine
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    • v.14 no.2
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    • pp.57-61
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    • 2012
  • To compare the accuracy of breath-hold magnetic resonance imaging sequences to establish the most effective superparamagnetic iron oxide-enhanced sequence for detection of hepatic metastases. A total of 100 patients(50men and 50women, mean age: 60years) with liver disease(including malignant and benign liver lesions) were investigated at 3.0T machine (GE, General Electric Medical System, Excite HD) with 8Ch body coil. Pulse sequence for MR imaging decided to the FS-T2-FSE-RT(TR/TE/Thick./Freq./Phase=12857ms/100ms/7mm/512/384), MGRE(TR/TE/Thick./Freq./Phase=100ms/9.7ms/7mm/384/288), in-out of phase echo(TR/$TE_1$, $TE_2$/Thick./Freq./Phase=140ms/2.4, 5.8ms/7mm/352/300), Images obtained before the injection of SPIO. Six sequences were optimized for lesion detection: FS-T2-FSE-RT, multigradient recalled echo data image(MGRE), T2-weighted MGRE with an 9.7msec echo time. Images were reviewed independently by five blinded observers. The accuracy of each sequence was measured by using picture archiving communication system analysis. All results were correlated with findings at multidectator computed tomography examination. Differences between the mean results of the six observers were measured by using paired student t-test analysis. Postcontrast T2-weighted MGRE sequences were the most accurate and were significantly superior to postcontrast FS-T2-FSE-RT, T2-weighted MGRE, in-out of phase MR sequences(p < .05). For all lesions that were malignant or smaller than 1 cm, respectively, contrast to noise ratio of pre and postcontrast sequences were -1and -0.3 for T2-weighted FSE, 0.53 and 4.5 in-out of phase, 7, 7.08, 5.08, 3.32, 1.7, 1.16, 0.79, 0.68 for GRE with 2.9, 7.5, 12.1, 16.6, 21.2, 25.8, 30.4, 35.0 TE values. Breath-hold various TE precontrast sequences offer improvement in sensitivity compared with fixed multigradient recalled echo sequences alone.

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Analysis of stress and distortion that develop during accelerated cooling of plate (가속냉각시 강판에 발생하는 응력 및 변형에 대한 연구)

  • 김호영;김창영;주웅용;장래웅
    • Transactions of the Korean Society of Mechanical Engineers
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    • v.12 no.5
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    • pp.952-958
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    • 1988
  • To analyze the nonflatness and residual stress in accelerated cooled plate, a numerical analysis model has been developed. Two factors, i.e. temperature and phase transformation, are considered in calculating the stress distribution that develops during cooling. The plastic strain and plate-buckling, which are often shown in accelerated cooled plate, were determined from this stress. Mean temperature in through thickness direction and temperature difference in width direction are considered in the model to simplify the calculation. The temperature and stress distribution changes caused by phase transformation are involved in terms of the effective specific heat and the effective thermal expansion coefficient. With the model, accelerated cooling of 10mm(t) $^{*}$3000mm(w) plate was simulated. The condition of accelerated cooling was .deg. C/sec from just after hot rolling to 500.deg. C. The initial temperature-difference ratio, .DELTA.Tr, in width direction is an important factor in evaluating the stress distribution. When .DELTA.Tr is 0.08, buckling occurs during cooling and 7kgf/m $m^{2}$ of residual stress develops at the edge of plate. To secure the flatness, .DELTA.Tr should be less than 0.07. Small scaled cooling test was conducted to verify the exactness of the model and the results proved the usefulness of this numerical analysis model.l.

Effect of Phenyl Vinyl Methyl Silicone (PVMQ) on Low Temperature Sealing Performance of Fluorosilicone Composites

  • Lee, Jin Hyok;Bae, Jong Woo;Choi, Myoung Chan;Yun, Yu-Mi;Jo, Nam-Ju
    • Elastomers and Composites
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    • v.56 no.4
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    • pp.209-216
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    • 2021
  • In this study, we observed the mechanical properties, thermal stability, and low temperature sealing performance of fluorosilicone elastic composites. When the blend ratio of Phenyl vinyl methyl silicone (PVMQ) was increased, the tensile strength, modulus at 100%, and compression set were decreased. The thermal stability of fluorosilicone elastic composites showed a similar tendency. These were caused by poorer green strength of PVMQ than Fluorosilicone rubber (FVMQ). The change in the tensile strength and elongation at -40℃ showed a decreasing tendency with increasing PVMQ blend ratio. By increasing the PVMQ blend ratio, low-temperature performance was improved. The Dynamic mechanical analysis (DMA) results showed that Tg was decreased and low-temperature performance was improved with increasing PVMQ blend ratio. However tanδ was decreased becaused of the poor green strength and elasticity of PVMQ. From a hysteresis loss at -40℃, the hysteresis loss value was increased and fluorosilicone elastic composites showed the decreasing tendency of elasticity with increasing PVMQ blend ratio. From the TR test, TR10 was decreased with increasing PVMQ blend ratio. FS-4 (45% PVMQ blended composites) showed a TR10 of -68.0℃ that was 5℃ lower than that of FS-1 (100% FVMQ). The gas leakage temperature was decreased with increasing PVMQ blend ratio. The gas leakage temperature of FS-4 was -69.2℃ that was 5℃ lower than that of FS-1. Caused by the polymer chain started to transfer from a glassy state to a rubbery state and had a mobility of chain under Tg, the gas leakage temperature showed a lower value than Tg. The sealing performance at low temperature was dominated by Tg that directly affected the mobility of the polymer chain.

The Effects of Squat Exercises with Vertical Whole-Body Vibration on the Center of Pressure and Trunk Muscle Activity in Patients with Low Back Pain

  • Kang, Jeongil;Jeong, Daekeun;Choi, Hyunho
    • Journal of International Academy of Physical Therapy Research
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    • v.11 no.4
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    • pp.2253-2260
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    • 2020
  • Background: Patients with low back pain (LBP) experience misalignments in the center of pressure (COP) and muscle imbalances due to frequent onesided posture adjustments to avoid pain. Objectives: To identify the effects of Squat Exercises with Vertical Whole-Body Vibration on the Center of Pressure and Trunk Muscle Activity. Design: Randomized controlled trial. Methods: Thirty LBP patients with an imbalance in the COP were sampled and randomly assigned to an experimental group of 15 patients who under went an intervention involving squat exercises with vertical WBV and a control group of 15 patients who were treated via a walking intervention. As pretests before the interventions, the subjects' COP was identified by measuring their stability index (ST), and erector spinae, rectus abdominis, transverse abdominis, gluteus medius muscle activity was analyzed by determining the % reference voluntary contraction (%RVC) value using surface electromyography while sit to stand. After four weeks, a post test was conducted to remeasure the same variables using the same methods. Results: Statistically significant differences were found in the ST (P<.01) and trunk muscle (P<.05, P<.001) in the experimental group before and after the intervention. In terms of the differences between the left- and right-side (RL) muscle activity, only the transverse abdominis (TrA) and gluteus medius (GM) exhibited statistically significant increase (P<.05). A comparison of the groups showed statistically significant differences in the TrA with respect to muscle activity (P<.05) and in the RLTrA and RLGM in terms ofthe difference between left- and right-side muscle activity (P<.01). Conclusion: Squat exercises with vertical WBV produced effective changes in the COP of patients with LBP by reducing muscle imbalances through the delivery of a uniform force. In particular, strengthening the TrA and reducing an imbalance in the GM were determined to be important factors in improving the COP.