• The Korean Journal of Applied Statistics
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• v.26 no.4
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• pp.675-686
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• 2013

The Korea Food and Drug Administration(KFDA) recommends the use of a $2{\times}2$ crossover design to assess the bioequivalence of generic drugs. However, a standard $2{\times}2$ crossover design for bioequivalence trials is often considered problematic due to ethical and economic issues as highly variable drugs are usually required by large numbers of subjects when designing the trial. To overcome this problem a $2{\times}4$ crossover design has been a recommended option as per US regulations; in addition, a $2{\times}3$ crossover design has also recently drawn special attention as an efficient alternative. The current KFDA regulation requires an ANOVA table for every bioequivalence study; however, ANOVA tables of $2{\times}4$ and $2{\times}3$ crossover designs have never been published in the literature. This study shows the derivation of tables of analysis of variance for a $2{\times}4$ cross-over design and a $2{\times}3$ cross-over design. We also suggest a sample size formulas for $2{\times}2$, $2{\times}4$ and $2{\times}3$ crossover designs to provide information on the selection of efficient designs for highly variable drugs.

• The Journal of The Korea Institute of Intelligent Transport Systems
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• v.11 no.4
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• pp.70-79
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• 2012

A design guide to type-3 PLLs for FMCW radars is provided. To do that, the cross-over frequencies of the open-loop transfer functions were normalized to 1 Hz and closed-loop properties were compared through simulations using Pspice. As a result, several guides to design type-3 PLLs were provided: 1) secure 45 degrees of phase margin, 2) locate two zeroes at an identical frequency, and 3) poles may be added to raise order of the PLL at higher frequencies than the cross-over frequency of the open-loop transfer function about ten times.

• The Korean Journal of Applied Statistics
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• v.23 no.1
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• pp.139-150
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• 2010

In recent years, more generic drug products became available. The current regulation for assessing the bioequivalence of two drug formulations is based on the concept of average bioequivalence. This approach has been indicated to be insufficient for assessing switchability between two drug formulations and US FDA has adopted individual bioequivalence as one of the bioequivalence criterion since 2001. The US FDA recommends that individual bioequivalence be assessed based on $2\;{\times}\;4$ crossover design, while a $2\;{\times}\;3$ crossover design may be used as an alternative design to reduce the length and cost of the study. In this paper, a statistical procedure for assessment of individual bioequivalence under $3\;{\times}\;2$ crossover designs is proposed and some statistical points are discussed with $2\;{\times}\;3$ crossover design and $2\;{\times}\;3$ extra-reference design through simulation studies.

• Biomolecules & Therapeutics
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• v.6 no.4
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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.

• ETRI Journal
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• v.33 no.5
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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.

• The Korean Journal of Rehabilitation Nursing
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• v.18 no.1
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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.

• The Journal of Korean Institute of Electromagnetic Engineering and Science
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• v.22 no.3
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• pp.399-405
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• 2011

In this paper, we present the design of Q-band LC VCO and injection locking buffer for 77 GHz automotive radar sensor using 130 nm RF CMOS process. To improve the phase noise characteristic of LC tank, the transmission line is used. The negative resistance by the active device cross-coupled pair of buffer is used for high output power, with or without oscillation of buffer. The measured phase noise is -102 dBc/Hz at 1 MHz offset frequency and tuning range is 34.53~35.07 GHz. The output power is higher than 4.1 dBm over entire tuning range. The fabricated chip size is $510{\times}130\;um^2$. The power consumption of LC VCO is 10.8 mW and injection locking buffer is 50.4 mW from 1.2 V supply.

• Child Health Nursing Research
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• v.24 no.4
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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.

• Journal of Pharmaceutical Investigation
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• v.28 no.4
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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.

• Journal of dental hygiene science
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• v.19 no.1
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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.