• The Korean Journal of Applied Statistics
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• v.29 no.2
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• pp.279-289
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• 2016

Bioequivalence trials based on higher order crossover designs have recently been conducted for highly variable drugs since the Ministry of Korea Food and Drug Safety (MFDS) added new regulations in 2013 to widen bioequivalence limits for highly variable drugs. However, a statistical discussion of higher order crossover designs have not been discussed yet. This research proposes the statistical inference of bioequivalence based on $3{\times}3$ crossover design and discusses it with the MFDS regulations. An illustrated example is also given.

• Journal of the Korean Data and Information Science Society
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• v.25 no.6
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• pp.1181-1193
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• 2014

Currently Ministry of food and drug safety allows add-on trial when the bioequivalence between two drugs fails to show since July 1, 2008. However, bioequivalence of highly variable drugs based on $2{\times}2$ crossover designs would require too many subjects, so the alternative designs like $2{\times}4$ or $2{\times}3$ crossover experiments are preferred. In this paper, we propose and discuss the statistical procedures for add-on trials in $2{\times}4$ and $2{\times}3$ crossover designs.

• 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 Korean Journal of Applied Statistics
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• v.24 no.6
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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.

• Korean Journal of Adult Nursing
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• v.22 no.1
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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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• v.28 no.4
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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.

• Proceedings of the KIEE Conference
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• 1997.11a
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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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• v.29 no.2
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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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• v.14 no.4
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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.

• Journal of the Korea Fashion and Costume Design Association
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• v.12 no.1
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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.