• Title/Summary/Keyword: equivalence test

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Studies on the Bioequivalence Test of Isoniazid Tablets (시판 이소니아짓 정제의 생물학적 동등성시험에 관한 연구)

  • Choi, Jun-Shik;An, Seon-Yeob
    • YAKHAK HOEJI
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    • v.33 no.4
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    • pp.229-236
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    • 1989
  • Even though two different preparations are chemically equivalent, the variance of bioavailability differenciates the clinical effect of preparations, so that the preparations need to be evaluated by comparing bioavailability in vivo as well as chemical equivalence. In this study, bioequivalence tests of commercially available isoniazid tablets A, B, C and D (standard) were performed to give some guidelines to bioequivalence test. The bioavailability parameters obtained by drug administeration were statistically analyzed. Statistical evaluation of the data involved an analysis of variance for a cross over design. Cross over design was employed with 8 healthy volunteers. The results were within 20% difference of mean value in the AUC, Cmax, Tmax and amount of urinary excretion (Au) between standard and isoniazid tablets. The results of ANOVA showed no significant differences for 'group or sequence', but almost not for 'between subjects'. The tablet. A, B and D were within 20 min, but tablet C was within 50 min. Tablet A was biologically equivalent in the Au. tablet B biologically equivalent in the Au and AUC. Tablet C was biologically equivalent in the Au. The relationship between the dissolution rate and Au was significant.

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Food-Effect Bioavailability and Fed Bioequivalence Studies (생체이용률에 미치는 음식물의 영향 및 식후 생물학적동등성시험)

  • Choi, Sun-Ok;Kwon, Kwang-Il;Jung, Sung-Hee;Um, So-Young;Jung, Seo-Jeong;Kim, Joo-Il;Chung, Soo-Youn;Kim, Ok-Hee
    • Korean Journal of Clinical Pharmacy
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    • v.15 no.2
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    • pp.82-88
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    • 2005
  • A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies.

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The Passenger Car Equivalence Models for Noise Level of Large Vehicles (대형차 소음환산계수 산정방법)

  • Yu, Wan;Lee, Seung-Ju
    • Journal of the Korean Regional Science Association
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    • v.6 no.1
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    • pp.57-68
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    • 1990
  • The purpose of this study is to develop the models to predict the noise PCE (Passenger Car Equivalence) of large running vehicles through noise prediction models. The noises were measured at the distance of 7.5M, 11.0M, and 14.5M from the noise source with test vehicles running at the speed of 40 Km/h, 60 Km/h, and 80 Km/h while normal traffic were detoured. Total noise levels were measured while vehicles were running at given speeds, Engine noise level was considered as the noise of its idle running at the three vehicle speeds shown above friction noise level was ascertained by moving the vehicle at given speeds without the engin operating. The noise prediction models for each noise source were developed by factors which affect to the each noise level. As a result of this paper, the reduction of total vehicle noise by increasing the distance to the noise source from 10 M to 15 M is as much as that by dropping its speed from 60 Km/h to 40 Km/h. Also, the reduction of PCE of total noise of large vehicle by making the noise source to that by reducing its speed from 80 Km/h to 60 Km/h. Enging noise PCE, which is in range between 65 and 160, is larger than friction noise PCE which is in range 3.5 and 5.5. Engin noise is the main noise of the large vehicles while friction noise is that of the small vehicles. Machine noise for large vehicles, and engin noise for small vehicles should be tightly controlled to reduce the vehicle noise. A low noise engine and tire, and the shape of vehicle body are needed to be developed to reduce noise further.

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Cross-Cultural Studies in Fashion Marketing Discipline (패션마케팅 영역에서의 비교문화적 연구의 경향)

  • Cho, Yun-Jin;Yang, Su-Zin;Kim, Eun-Young;Choo, Ho-Jung
    • Journal of the Korean Society of Clothing and Textiles
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    • v.30 no.8
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    • pp.1312-1322
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    • 2006
  • A recent accelerated globalization has changed every aspect of consumers' life on the globe, thus understanding the similarity and the difference among people in the world became the crucial element of business for many global companies. As one of the most globalized industries in Korea, fashion businesses also require urgent assistance of academics in understanding global consumers. This study aimed to analyze cross-cultural fashion marketing studies published in two respectful journals in fashion studies: Journal of Korean Society of Clothing and Textiles and Journal of the Korean Society of Costume. Four researchers independently searched the target journals to locate studies using cross-cultural approaches. A total of 45 cross-cultural studies published in two journals between 1977 and 2005 were found and analyzed. The major findings could be summarized as followed. First, the US was the most frequently studied country followed by China, Japan, Hong Kong and others. Second, popular subjects of cross cultural studies in fashion marketing were fashion marketing environment and management rather than consumer psychology. Third, about 78% of the sampled studies were using quantitative approach, and statistical methods such as factor analysis, t-test, ANOVA, and $X^2$ analysis were commonly used. Finally, problems in sampling methods, translation of scales, and equivalence of concept, measure and sample were analyzed. Suggestions for future cross-cultural studies were discussed.

The Intervention Effect of Cognitive Improvement Program for Elderly with Mild Cognitive Impairment (경도인지장애 노인의 인지향상 프로그램 중재효과)

  • Song, Myeong Kyeong;Kim, Soon Ock;Kim, Chun Suk
    • Journal of Korean Public Health Nursing
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    • v.32 no.1
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    • pp.81-95
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    • 2018
  • Purpose: This study was conducted to identify the effects of a group cognitive improvement program on cognitive function, depression and self-esteem in elderly individuals with mild cognitive impairment. Methods: This was an experimental study that employed a pre-post design of a non-equivalence control group. The subjects were 52 elderly people with mild cognitive impairment, 25 of whom were assigned to the experimental group and 27 to the control group. The program was conducted for a total of 12 sessions for 60 minutes each. Data were analyzed using the ${\chi}2-test$, Fisher's exact test, and Independent t-test with the SPSS 20.0 program. Results: After the intervention, the group who participated showed improvement in all areas of cognitive function based on MMSE-KC (F=26.37, p.<0.001), the Rey Complex Figure Test: copy (F=20.66, p.<0.001), Immediate memory of Seoul Verbal Learning Test-Elderly's version (F=29.68, p.<0.001), delayed memory (F=45.79 p.<0.001), memory recall (F=28.97, p.<0.001), Forward of Digit Span Test (F=9.25, p=.004), backward (F=8.33, p.=0.006), language comprehension (F=13.42, p.<0.001), and digit symbol coding (F=17.74, p.<0.001) relative to the control group. Moreover depression (F=24.09, p.<0.001) was decreased in program participants, whereas self-esteem (F=40.24, p.<0.001) was increased. Conclusion: The program could be a useful intervention because the results show that the group cognitive improvement program has a significant effect on cognitive function, depression and self-esteem in elderly with mild cognitive impairment.

A Study on Accuracy of Meteorological Information for Low Altitude Aerospace around the Airport on the West Coast (서해안 인접공항의 저고도 항공기상 정확도 연구)

  • Cho, Young-Jin;Yoo, Kwang Eui
    • Journal of the Korean Society for Aviation and Aeronautics
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    • v.28 no.2
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    • pp.53-62
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    • 2020
  • This study is to evaluate the accuracy of the meteorological information provided for the aircraft operating at low altitude. At first, it is necessary to identify crucial elements of weather information closely related to flight safety during low altitude flights. The study conducted a survey of pilots of low altitude aircraft, divided into pre-flight and in-flight phases, and reached an opinion that wind direction, wind speed, cloud coverage and ceiling and visibility are important items. Related to these items, we compared and calculated the accuracy of TAFs and METARs from Taean Airfield, Seosan Airport and Gunsan Airport because of their high number of domestic low-altitude flights. Accuracy analysis evaluated the accuracy of two numerical variables, Mean Absolute Error(MAE) and Root Mean Square Error(RMSE), and the cloud coverage which is categorical variable was calculated and compared by accuracy. For numeric variables, one-way ANOVA, which is a parameter-test, was approached to identify differences between actual forecast values and observations based on absolute errors for each item derived from the results of MAE and RMSE accuracy analyses. To determine the satisfaction of both normality assumptions and equivalence variability assumptions, the Shapiro-Wilk test was performed to verify that they do not have a normality distribution for numerical variables, and for the non-parametric test, Kruscal-Wallis test was conducted to determine whether or not they are satisfied.

Combustion Test for a Supersonic Combustor Using a Direct-Connected Facility (직결형 설비를 이용한 초음속 연소기 연소 시험)

  • Yang, Inyoung;Lee, Kyung-Jae;Lee, Yang-Ji;Lee, Sanghoon;Kim, Hyungmo;Park, Poomin
    • Journal of the Korean Society of Propulsion Engineers
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    • v.22 no.3
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    • pp.1-7
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    • 2018
  • A combustion test for a supersonic combustor was conducted using a direct-connected type supersonic combustor test facility. The facility was verified for the capability of simulating required flow conditions. The test condition was maintained at Mach 2.0, $915^{\circ}C$ and 496 kPa for 15 s. Using gaseous hydrogen as the fuel, the combustor model was also tested for its ignition and flame holding capability at the fuel equivalence ratio of 0.12. Combustion efficiency was 71%, and the supersonic flow regime was obtained at this test condition.

Evaluation of Rail Fatigue Life by Rail Grinding in the High Speed Railway (레일연마에 따른 고속철도 레일 피로수명 평가)

  • Park, Won-Seo;Lim, Hyung-Jun;Park, Yong-Gul;Sung, Deok-Yong;Kang, Yoon-Suk
    • Proceedings of the KSR Conference
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    • 2011.10a
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    • pp.783-792
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    • 2011
  • The control of rail surface irregularity is very important for the high speed train service in the high speed rail. In order to manage it, initial, preventative, and maintainable rail grinding have been performed and among them, preventative rail grinding conducts in every each year. This study carried out the field test for dynamic track response according to rail surface irregularity comparing before and after rail grinding. In addition, the change of dynamic track responses according to rail grinding was analyzed and the fatigue life was estimated though Rainflow Counting Method and RMC Equivalence Stress. Therefore, it suggested that rail fatigue life should be increased by rail grinding, because amount of impact occurred on track is decreased by getting rid of rail surface irregularity.

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Statistical Assessment of Biosimilarity based on the Relative Distance between Follow-on Biologics in the (k + 1)-Arm Parallel Design

  • Kang, Seung-Ho;Shin, Wooyoung
    • Communications for Statistical Applications and Methods
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    • v.22 no.6
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    • pp.605-613
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    • 2015
  • A three-arm parallel design has been proposed to assess the biosimilarity between a biological product and a reference product using relative distance (Kang and Chow, 2013). The three-arm parallel design consists of two arms for the reference product and one arm for the biosimilar product. This paper extended the three-arm parallel design to a (k + 1)-arm parallel design composed of k (${\geq}3$) arms for the reference product and one arm for the biosimilar product. A new relative distance was defined based on Euclidean distance; consequently, a corresponding test procedure was developed based on asymptotic distribution. Type I error rates and powers were investigated both theoretically and empirically.

A Study on the Development of Combustor for Turbocharger Test Facilities (터보챠저 구동용 연소기 개발에 관한 연구)

  • Oh, Kook-Taek;Park, Boo-Min;Kim, Hong-Won;Ryu, Seung-Hyup;Ha, Ji-Soo
    • Proceedings of the KSME Conference
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    • 2001.06d
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    • pp.43-48
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    • 2001
  • Combustor design technique is established by reverse engineering of existing combustor and applying heat & mass balance equations for the combustion process. The ratio of entrained air for each air slot is found to be almost proportional to the area ratio from the result of numerical simulation. The shape of the combustor is modified by the numerical analysis to get circumferentially uniform flow inside the combustion chamber required for the flame stability.

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