• 제목/요약/키워드: $2{\times}4$ cross-over design

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생물학적 동등성 시험을 위한 2×k 교차설계법의 통계적 고려 (Some Statistical Considerations on 2×k Crossover Designs for Bioequivalence Trial)

  • 노소영;박상규
    • 응용통계연구
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    • 제26권4호
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    • pp.675-686
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    • 2013
  • 현재 우리나라 식품의약품안전청에서는 $2{\times}2$ 교차설계법을 기초로 제제간의 생물학적 동등성 평가를 수행하도록 규정하고 있다. 하지만 고변동성 제제의 생물학적 동등성 평가에서 $2{\times}2$ 교차설계법에 의한 시험은 지나치게 많은 피험자를 필요로 할 수 있어 윤리적이고 경제적인 고려가 필요하다는 논의가 이루어지고 있다. $2{\times}2$ 교차설계법을 대체할 수 있는 대안으로 $2{\times}4$ 교차설계법은 미국 및 유럽 등에서는 생물학적 동등성 평가에 광범위하게 사용되는 설계 방법이고, $2{\times}3$ 교차설계법도 $2{\times}2$$2{\times}4$ 교차설계법의 단점을 개선할 수 있는 효율적인 대안으로 관심이 많다. 본 연구에서는 $2{\times}4$$2{\times}3$ 교차설계법의 통계적 모형과 제시된 통계적 모형에 연계된 분산분석표를 유도한다. 현행 국내 생물학적 동등성 시험 규정에 의하면 $2{\times}4$$2{\times}3$ 교차설계법의 분산분석표는 반드시 제시되어야 하지만 아직 문헌상에 존재하지 않아 관련 연구에 기여할 것으로 생각된다. 또한 $2{\times}4$$2{\times}3$ 교차설계법에 기초한 피험자 계산을 $2{\times}2$ 교차설계법과 비교 제시하여 고변동성 제제의 생물학적 동등성 시험 연구에 적절한 시험 설계 선택에 정보를 제공한다.

FMCW 레이더용 타입-3 PLL의 설계 가이드 (A Design Guide to Type-3 PLLs for FMCW Radars)

  • 황인덕;김창환
    • 한국ITS학회 논문지
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    • 제11권4호
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    • pp.70-79
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    • 2012
  • FMCW 레이더에서 주파수 램프 신호를 발생시키기 위하여 필요한 타입-3 PLL의 설계 가이드를 제시하였다. 그러기 위해서 개루프 전달함수의 크로스오버 주파수를 1 Hz로 정규화 한 조건에서 Pspice 시뮬레이션을 통하여 폐루프 특성을 비교하였다. 결론적으로 타입-3 PLL의 1) 위상여유는 45도로 하고, 2) 두 개의 영점은 같도록 하며, 3) PLL 차수를 높이기 위한 극점은 개루프 전달함수의 크로스오버 주파수보다 10배 정도 크게 할 것을 권한다.

3 X 2 교차설계법에서 개인 생물학적 동등성 검정 (Individual Bioequivalence Tests under 3 X 2 Design)

  • 정규진;임남규;박상규
    • 응용통계연구
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    • 제23권1호
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    • pp.139-150
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    • 2010
  • 최근들어 복제약(generic drug)의 개발이 활발히 이루어지고 있다. 현재 국내 생물학적 동등성 시험은 기존의 오리지널제제에 대하여 개발된 복제약이 동일한 질(quality), 안전성(safety) 그리고 효과(efficucy)를 갖는다는 것을 평균 생물학적 동등성(ABE)에 기초하여 증명하고 있다. 그러나 최근에 생물학적 동등성의 개념이 기존의 오리지널제제에 대하여 바꾸어 복용(switchability)할 수 있다는 개인 생물학적 동등성(IBE)의 개념으로 확장되었다. 미국 식약청은 개인 생물학적 동등성(IBE)을 평가하기 위하여 $2\;{\times}\;4$ 교차설계법을 권장하고 있다. 그러나 $2\;{\times}\;4$ 교차설계법은 실험기간이 길기 때문에 비용이나 피험자관리에 여러 가지 문제가 있어 실험기간을 줄인 $2\;{\times}\;3$교차설계법과 Chow 등 (2002)의 $2\;{\times}\;3$ 잉여대조 (extra-reference) 설계법이 제안되었다. 본 논문에서는 실험기간이 짧으면서 개인 생동성을 평가할 수 있는 $3\;{\times}\;2$ 교차설계법을 제안하고 모의실험을 통하여 $2\;{\times}\;3$ 교차설계법과 $2\;{\times}\;3$ 잉여대조 설계법과 비교 및 그 결과를 고찰하였다.

Loxoprofen sodium 제제(레녹스정)의 생물학적 동등성시험 (Bioequivalence Study of Loxoprofen Sodium in healthy Volunteers)

  • 최주영;유내춘;박민수;김경환
    • Biomolecules & Therapeutics
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    • 제6권4호
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    • pp.417-422
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    • 1998
  • Loxoprofen sodium (sodium 2-[4-(2-oxocyclopentylmethyl)phenyl] propionate dehydrate) is a nonsteroidal antiinflammatory drug of $\alpha$-phenyl propionic acid derivative. To test the bioequivalence of loxoprofen, the pharmacokinetic parameters of new preparation of loxoprofen, LENOX was compared with LOXONIN as a reference drug. Fourteen healthy volunteers were entered to the stydy (Yonsei University College of Medicine, Severance Hospital IRB approval No. 9608). They were administered 60 mg of loxoprofen in 2$\times$2 cross-over design. There was one week of drug-free interval between doses. The blood sample was taken on schedule up to 8 hours, and the plasma concentration loxoprofen was measured by reverse phase high-performance liquid chromatography (HPLC) with UV-detector. There were no significant difference between two preparations when AUC, Cmax, and Tmax were compared by ANOVA. The mean differences of AUC, Cmax, and Tmax were within 20% of the reference drug: the values were 2.22,5.61, and 12.50%, respectively. The confidence limits of AUC and Cmax but not Tmax satisfied the bioequivalence criteria. These results suggest that the tested LENOX is bioequivalent to the reference drug.

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GCC2Verilog Compiler Toolset for Complete Translation of C Programming Language into Verilog HDL

  • Huong, Giang Nguyen Thi;Kim, Seon-Wook
    • ETRI Journal
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    • 제33권5호
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    • pp.731-740
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    • 2011
  • Reconfigurable computing using a field-programmable gate-array (FPGA) device has become a promising solution in system design because of its power efficiency and design flexibility. To bring the benefit of FPGA to many application programmers, there has been intensive research about automatic translation from high-level programming languages (HLL) such as C and C++ into hardware. However, the large gap of syntaxes and semantics between hardware and software programming makes the translation challenging. In this paper, we introduce a new approach for the translation by using the widely used GCC compiler. By simply adding a hardware description language (HDL) backend to the existing state-of- the-art compiler, we could minimize an effort to implement the translator while supporting full features of HLL in the HLL-to-HDL translation and providing high performance. Our translator, called GCC2Verilog, was implemented as the GCC's cross compiler targeting at FPGAs instead of microprocessor architectures. Our experiment shows that we could achieve a speedup of up to 34 times and 17 times on average with 4-port memory over PICO microprocessor execution in selected EEMBC benchmarks.

뜸 요법이 노인의 만성 요통과 일상생활 활동장애에 미치는 효과 (The Effects of Moxibustion on Chronic Back Pain and Activities of Daily Living in Aged)

  • 유혜숙;박경숙
    • 재활간호학회지
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    • 제18권1호
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    • pp.38-45
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    • 2015
  • Purpose: This study was attempted in order to verify the effects of moxibustion on aged back pain and activities of daily living. Methods: A research design is quasi-experiment with pre-post test design in nonequivalent control group. As for data collection and experimental treatment, it accidentally sampled totally 50 people with 24 people for the experimental group and 26 people for the control group who appeal for chronic back pain aged over 60 who visited 4 senior centers where are located in N city from November 7, 2012 to December 3, 2012. Experimental treatment was carried out moxibustion totally 12 times by 3 times for 4 weeks in the experimental group. Data analysis was made by using SPSS program. As an analytical technique, the experimental group and the control group were analyzed the homogeneity verification with t-test, Fisher's exact test and $x^2$ test and the hypothesis verification with t-test. Results: The back pain level was reduced in the experimental group than the control group. The disability of daily living activities was reduced in the experimental group than in the control group. Conclusion: Moxibustion was considered to be likely useful therapeutic method for effects of chronic back pain and disability of daily living activities in aged.

77 GHz 자동차용 레이더 센서 응용을 위한 Q-밴드 LC 전압 제어 발진기와 주입 잠금 버퍼 설계 (Design of Q-Band LC VCO and Injection Locking Buffer 77 GHz Automotive Radar Sensor)

  • 최규진;송재훈;김성균;;남상욱;김병성
    • 한국전자파학회논문지
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    • 제22권3호
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    • pp.399-405
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    • 2011
  • 본 논문에서는 130 nm RF CMOS 공정을 이용하여 77 GHz 자동차용 레이더 센서에 응용 가능한 Q-band LC 전압 제어 발진기(Voltage Controlled Oscillator: VCO)와 주입 잠금(injection locking) 버퍼를 설계한 결과를 보인다. LC 탱크의 위상 잡음 특성 개선을 위해 전송선을 이용하였고, 버퍼는 능동 소자 교차 결합쌍(cross-coupled pair)의 부성 저항(negative resistance)단을 이용해 발진 유무에 관계없이 높은 출력 전력을 가지도록 설계하였다. 측정된 위상 잡음은 1 MHz 오프셋 주파수에서 -102 dBc/Hz이며, 주파수 조정 범위는 34.53~35.07 GHz이다. 또한, 모든 주파수 조정 범위에서 출력 전력은 4.1 dBm 이상의 값을 가진다. 제작된 칩의 사이즈는 $510{\times}130\;um^2$이며, 1.2 V 바이어스 전압에서 LC 전압 제어 발진기가 10.8 mW, 주입 잠금 버퍼가 50.4 mW의 전력 소모를 가진다.

대학생을 위한 블렌디드 러닝 기법의 성 교육 프로그램 개발 및 효과 (Development and Effects of a Sex Education Program with Blended Learning for University Students)

  • 김일옥;염계정;김미정
    • Child Health Nursing Research
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    • 제24권4호
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    • pp.443-453
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    • 2018
  • Purpose: This study was describes the development and implementation a sex education program with a blended learning method for university students. Methods: Sixty-eight university students were recruited either to the experimental group (n=35) or the control group (n=33). This program was developed based on the analysis, design, development, implementation, and evaluation model. The analysis phase consisted of a literature review, focus group interview, expert consultations, and target group survey. In addition, learning objectives and structure were designed, and a printed text-book, presentation slides, cross-word puzzle, and debate topics were developed. In the implementation phase, the program was conducted 3 times over the course of 3 weeks. The evaluation phase involved verification of the effects of the program on sex-related knowledge, sexual autonomy, and justification of violence, as well as an assessment of satisfaction with the program. Results: The experimental group had significantly higher scores on sex-related knowledge (t=5.47, p<.001), sexual autonomy (t=2.40, p=.019), and justification of violence (t=2.52, p=.015) than the control group. Conclusion: The results indicate that this sex education program with blended learning was effective in meeting the needs of university students and can be widely used in this context.

$K-BEtest^{\circledR}$, 새로운 생물학적 동등성 시험 통계처리 프로그램의 개발 (Development of $K-BEtest^{\circledR}$, a Computer Program for the Analysis of Bioequivalence)

  • 이영주;최정호;송세흠;서철환;김동섭;박인숙;최기환;나한광;정석재;이민화;심창구
    • Journal of Pharmaceutical Investigation
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    • 제28권4호
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    • pp.223-229
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    • 1998
  • A computer program for personal computers, $K-BEtest^{\circledR}$, was developed to analyze bioequivalence data in accordance with Korean Guidelines for Bioequivalence Test (KGBT). This program is user-friendly, interactive, Hangul-compatible and supports $2{\times}2$ cross-over design as well as $2{\times}2$ Latin square design with various significance levels. This program is able to calculate AUC, $C_{max}$ and $T_{max}$ parameters from the blood drug concentration-time profile of individual subjects and evaluate the parameters statistically for the bioequivalence by ${\pm}20%$ rule, the F-test, the Non-centrality test and 90% confidence intervals. All procedures are supported with graphic interface, interactive menu and outputs in Korean. In this paper, two experimental data sets were analyzed by the program and detailed process was demonstrated. The $K-BEtest^{\circledR}$ program appears to be very effective for analyzing bioequivalence data and can be widely used with convenience and accuracy.

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Factors Associated with Unmet Dental Needs among Single-Person Households in Korea

  • Kim, Dong-Hwi;Kim, Hyeongmi
    • 치위생과학회지
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    • 제19권1호
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    • pp.48-59
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    • 2019
  • Background: The purpose of this study is to provide the data for discussions related to oral health promotion policies for single-person households by analyzing the status of unmet dental needs and related factors in single-person households in Korea, based on the Anderson model. Methods: The data, obtained from 544 single-person households of those over 20 years old who were targeted for the 6th Korea National Health and Nutrition Examination Survey, were analyzed through a complex sample frequency analysis, complex sample cross analysis (Rao-Scott chi-square test), and complex sample binary logistic regression analysis on a complex sampling design. Results: The most frequently given reason for an unmet dental need among single-person households was economic (52.4%). Factors related to the unmet dental needs of single-person households are smoking, which is a predisposing factor; personal income levels, which are an enabling factor; chewing discomfort; and limited daily activities, which are need factors. Smokers, the high-income group, the chewing-discomfort group, and the limited activity group showed high unmet dental care experience. Smokers had a 2.75 times higher rate of unmet dental care than non-smokers, and the high-income group had a 5.29 times higher rate of unmet dental needs than the median group. The rate of unmet dental needs for the chewing discomfort group was 3.27 times higher than the non-chewing discomfort group, and the limited activity group had a 7.87 times higher rate of unmet dental needs than the non-limited activity group. Conclusion: It is necessary to map out policies designed to help maintain and promote met dental needs considered to be internally heterogeneous to single-person householders, based on the Anderson model.