• 응용통계연구
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• 제29권2호
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• pp.279-289
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• 2016

최근 식품의약품안전처는 의약품동등성시험기준에 고변동성 제제의 생물학적 동등성(생동성) 평가 기준을 넓혀주는 새로운 규정을 추가하면서 고차 교차설계법을 활용하여 생동성 평가를 하는 논의가 확대되고 있다. 확장된 생동성 기준을 적용하기 위해서는 3기간 이상의 교차설계법이 적용되어야 하지만 아직 관련된 논의가 많이 이루어지지 않고 있다. 본 연구에서는 $3{\times}3$ 교차설계법에 기초한 생동성 평가의 통계적 추론과정을 제시하고 논의한다. 또한 사례를 통해 $3{\times}3$ 교차설계법을 활용한 생동성 평가를 식품의약품안전처 의약품동등성시험기준에 따라 진행하고 그 의미를 논의한다.

• Journal of the Korean Data and Information Science Society
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• 제25권6호
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• pp.1181-1193
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• 2014

현재 식품의약품안전처에서는 2008년 7월부터 $2{\times}2$ 교차설계법으로 수행된 제제간의 생물학적 동등성 입증이 실패했을 때 1회에 한하여 추가시험을 허용하고 있다. 하지만 최근 생체이용률의 변동계수가 30% 이상인 고변동성 제제가 많이 등장하면서 $2{\times}2$ 교차설계법에 의한 생물학적 동등성 시험수행에 지나치게 많은 피험자가 소요되면서 그 대안으로 $2{\times}4$ 혹은 $2{\times}3$ 교차설계법을 활용해야 하는 필요성이 증대되고 있다. 본 연구에서는 $2{\times}4$ 혹은 $2{\times}3$ 교차설계법에 기반한 제제의 생물학적 동등성 평가의 추가시험에 대한 통계적 절차를 제안하고 논의하고자 한다.

• 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 $2{\times}2$와 $2{\times}4$ 교차설계법의 단점을 개선할 수 있는 효율적인 대안으로 관심이 많다. 본 연구에서는 $2{\times}4$와 $2{\times}3$ 교차설계법의 통계적 모형과 제시된 통계적 모형에 연계된 분산분석표를 유도한다. 현행 국내 생물학적 동등성 시험 규정에 의하면 $2{\times}4$와 $2{\times}3$ 교차설계법의 분산분석표는 반드시 제시되어야 하지만 아직 문헌상에 존재하지 않아 관련 연구에 기여할 것으로 생각된다. 또한 $2{\times}4$와 $2{\times}3$ 교차설계법에 기초한 피험자 계산을 $2{\times}2$ 교차설계법과 비교 제시하여 고변동성 제제의 생물학적 동등성 시험 연구에 적절한 시험 설계 선택에 정보를 제공한다.

• 응용통계연구
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• 제24권6호
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• pp.1095-1102
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• 2011

The classical two-period, two-sequence crossover design is no longer sufficient to assess various demands in a bioequivalence study. For instance, to estimate the within-subject and between-subject variances of test and reference formulations separately, it is necessary to use a replicate design in which each subject receives at least the reference formulation in two periods. Several designs were studied to satisfy the demands. It is provided a unified Bayesian approach applicable to those study designs. The benefit of the method in the bioequivalence study is discussed.

• 성인간호학회지
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• 제22권1호
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• pp.31-40
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• 2010

Purpose: The purpose of this study was to examine whether there is difference in the effects of aromatherapy on dysmenorrhea by research design. Methods: Findings from the two different research designs (Nonequivalent control group pretest-posttest [NCG] design vs. two-group crossover design) were compared in regard to the effect of aromatherapy on dysmenorrhea. The subjects of the NCG design and the crossover design were a total of 58 female nursing students. The treatments (aroma essential oil inhalation and carrier oil inhalation) were given using a necklace. The data were analyzed by Fisher's exact test, t-test, Mann-Whitney test, paired t-test, and Shapiro-Wilk test using the SPSS/WIN 12.0 program. The effect size for the two research designs was calculated. Results: In both research designs, the level of dysmenorrhea and menstrual pain after the aroma treatment were not significantly different from those after the placebo treatment. The effect size of the NCG design was higher than that of the crossover design. Conclusion: Aroma inhalation may not be effective in managing dysmenorrhea and menstrual pain. In order to further clarify the efficiency of research design and the effect of aromatherapy on discomfort during menstruation, replication studies are necessary. Future studies need to examine the effects of different research design on non-interval variables.

• Journal of Pharmaceutical Investigation
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• 제28권4호
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• pp.231-239
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• 1998

A $3{\times}2$ crossover design is considered for the bioequivalence of two test formulations with a control. It could be considered as a better choice over $3{\times}3$ crossover design because of the cost and experimental duration. Oh et al.(1998) derived $3{\times}2$ crossover design and discussed its benefits over the typical crossover designs. We consider here the statistical models for $3{\times}2$ crossover design and show its statistical properties. The statistical procedures for the bioequivalence in $3{\times}2$ crossover design are shown through an example and the results are summarized by satisfying the 3 standards that proposed by the Korea Food and Drug Administration Guidelines for Bioequivalence.

• 대한전기학회:학술대회논문집
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• 대한전기학회 1997년도 추계학술대회 논문집 학회본부
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• pp.257-260
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• 1997

This paper designs the optimal PID controller for load frequency control on 2-area power system. Genetic algorithm is utilized to optimize parameters of PID controller which is applied to power system. Using two-point crossover, uniform crossover and one-point crossover, Search performance of genetic algorithm with each crossover method is considered. In case of load variation in 1-area, the dynamic characteristic of power system is considered. The simulation results show that the proposed PID controller is better control performance than PID controller using Ziegler-Nichols method.

• Journal of the Korean Statistical Society
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• 제29권2호
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• pp.219-229
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• 2000

Oh et al.(1999) 3$\times$2 crossover design for assessing bioequivalence when two new generic drug formulations and innovator are simultaneously considered. This design is not only more efficient than 3$\times$3 one, proposed by Lee et al.(1998), in practical sense, but also more ethical in medical sense. However, the general statistical methods are not directly applicable to both designs when subjects are dropped out in the experiment, even though it is always possible in bioavailability and bioequivalence studies because of some administrative and economic reasons. In this research we propose an inference to drug effects when subjects are dropped out in the planed-for 3$\times$3 and 3$\times$2 crossover experiments. An example is given for illustration.

• International Journal of Aeronautical and Space Sciences
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• 제14권4호
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• pp.341-349
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• 2013

This paper considers the optimum design of flexbeam cross-sections for a full-scale bearingless helicopter rotor, using an efficient hybrid optimization algorithm based on particle swarm optimization, and an improved genetic algorithm, with an effective constraint handling scheme for constrained nonlinear optimization. The basic operators of the genetic algorithm, of crossover and mutation, are revisited, and a new rank-based multi-parent crossover operator is utilized. The rank-based crossover operator simultaneously enhances both the local, and the global exploration. The benchmark results demonstrate remarkable improvements, in terms of efficiency and robustness, as compared to other state-of-the-art algorithms. The developed algorithm is adopted for two baseline flexbeam section designs, and optimum cross-section configurations are obtained with less function evaluations, and less computation time.

• 한국의상디자인학회지
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• 제12권1호
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• pp.103-116
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• 2010

In view of our contemporary fashion, it is found that crossover between clothing and other items leads to creation of a new design and crossover of various cultural codes, ultimately creating a multicultural clothing design or any external outline of emerging costume designs by attempting mutual combination with other fields. Starting from a viewpoint that mutual combination style has significant effects on our contemporary fashion designs, this study intends to characterize external aspects of fashion design that changes through mutual combination style. This study focused upon analyzing costumes released by contemporary fashion designers after 2000, and addressed a variety of mutual combination styles. It gives various examples on mutual combination in fashion, seeking first to look into typical examples of mutual combination styling between fashion and art, between fashion and space and between fashion and technology. Based on those examples, this study classified crossover styles into 6 major categories such as attachment, suspension, modification, fusion, association and embedment. As a result, this study comes to a conclusion that external changes by mutual combination are characterized largely by overlap, simultaneity and deconstruction.