• 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.

• 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.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.

• 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.

• Journal of the Korea Society of Computer and Information
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• v.28 no.3
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• pp.101-110
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• 2023

This study was conducted to identify factors influencing weight loss efforts in hypertensive patients with obesity in Korea using data from the 2016-2019 National Health and Nutrition Examination Survey. Weight perception, weight loss efforts, and weight control methods were investigated for 1,910 subjects. Data were analyzed using descriptive analysis, cross-tabulation analysis and logistic regression. Among obese hypertensive patients, 12.6% perceived their weight as normal. Weight loss efforts were 2.03 times (95% CI: 1.48 to 2.78) higher in people with overweight perception than those with normal weight perception, and 1.74 times (95% CI: 1.33 to 2.26) higher in women than in men. In addition, those with class 1 obesity were 1.50 times (95% CI: 0.85 to 2.65) higher than those with class 3 obesity, and those with class 2 obesity were 2.16 times (95% CI: 1.16 to 4.00) higher than those with class 3 obesity. These results suggest that weight management approaches for hypertensive patients with obesity should be individually designed according to weight perception, gender, and obesity class.