• The Korean Journal of Applied Statistics
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• v.16 no.2
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• pp.455-467
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• 2003

There has been a long debate on the applicability of the chi-square approximation to statistics based on small sample size. Extending comparison results among Pearson chi-square Χ$^2$, generalized likelihood .ratio G$^2$, and the power divergence Ι(2/3) statistics suggested by Rudas(1986), recently developed disparity statistics (BWHD(1/9), BWCS(1/3), NED(4/3)) we compared and analyzed in this paper. By Monte Carlo studies about the independence model of two dimension contingency tables, the conditional model and one variable independence model of three dimensional tables, simulated 90 and 95 percentage points and approximate 95% confidence intervals for the true percentage points are obtained. It is found that the Χ$^2$, Ι(2/3), BWHD(1/9) test statistics have very similar behavior and there seem to be applcable for small sample sizes than others.

• Korean Journal of Veterinary Research
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• v.50 no.1
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• pp.43-48
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• 2010

Animal disease surveillance system, defined as the continuous investigation of a given population to detect the occurrence of disease or infection for control purposes, has been key roles to assess the health status of an animal population and, more recently, in international trade of animal and animal products with regard to risk assessment. Especially, for a system aiming to determine whether or not a disease is present in a population sensitivity of the system should be maintained high enough not to miss an infected animal. Therefore, when planning the implementation of surveillance system a number of factors that affecting surveillance sensitivity should be taken into account. Of these parameters sample size is of important, and different approaches are used to calculate sample size, usually depending on the objective of surveillance systems. The purpose of this study was to evaluate the sensitivity of the current national serological surveillance programs for four selected bovine diseases assuming a specified sampling plan, to examine factors affecting the probability of detection, and to provide sample sizes required for achieving surveillance goal of detecting at least an infection in a given population. Our results showed that, for example, detecting low level of prevalence (0.2% for bovine tuberculosis) requires selection of all animals per typical Korean cattle farm (n = 17), and thus risk-based target surveillance for high risk groups can be an alternative strategy to increase sensitivity while not increasing overall sampling efforts. The minimum sample size required for detecting at least one positive animal was sharply increased as the disease prevalence is low. More importantly, high reliability of prevalence estimation was expected with increased sampling fraction even when zero-infected animal was identified. The effect of sample size is also discussed in terms of the maximum prevalence when zero-infected animals were identified and on the probability of failure to detect an infection. We suggest that for many serological surveillance systems, diagnostic performance of the testing method, sample size, prevalence, population size, and statistical confidence need to be considered to correctly interpret results of the system.

• Journal of Preventive Medicine and Public Health
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• v.53 no.5
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• pp.342-352
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• 2020

Objectives: The aim of this retrospective cohort study was to investigate whether non-alcoholic fatty liver disease (NAFLD) was associated with incident bone mineral density (BMD) decrease. Methods: This study included 4536 subjects with normal BMD at baseline. NAFLD was defined as the presence of fatty liver on abdominal ultrasonography without significant alcohol consumption or other causes. Decreased BMD was defined as a diagnosis of osteopenia, osteoporosis, or BMD below the expected range for the patient's age based on dual-energy X-ray absorptiometry. Cox proportional hazards models were used to estimate the hazard ratio of incident BMD decrease in subjects with or without NAFLD. Subgroup analyses were conducted according to the relevant factors. Results: Across 13 354 person-years of total follow-up, decreased BMD was observed in 606 subjects, corresponding to an incidence of 45.4 cases per 1000 person-years (median follow-up duration, 2.1 years). In the model adjusted for age and sex, the hazard ratio was 0.65 (95% confidence interval, 0.51 to 0.82), and statistical significance disappeared after adjustment for body mass index (BMI) and cardiometabolic factors. In the subgroup analyses, NAFLD was associated with a lower risk of incident BMD decrease in females even after adjustment for confounders. The direction of the effect of NAFLD on the risk of BMD decrease changed depending on BMI category and body fat percentage, although the impact was statistically insignificant. Conclusions: NAFLD had a significant protective effect on BMD in females. However, the effects may vary depending on BMI category or body fat percentage.

• Biomolecules & Therapeutics
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• v.9 no.4
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• pp.285-290
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• 2001

Bioequivalence of two acetyl-1-carnitine tablets, test product (Carnitile tablet: Hanmi Pharm. Co., Ltd.) and reference product (Nicetil $e^{R}$ tablet: Dong-A Pharm. Co., Ltd.), was evaluated according to the guide- lines of Korea Food and Drug Administration (KFDA). Twenty-six healthy volunteers were divided randomly into two groups and administered the drug orally at the dose of 500 mg as acetyl-1-carnitine in a 2$\times$2 crossover study. Blood samples were taken at predetermined time intervals for 12 hours and the plasma concentration of acetyl-1-carnitine was determined using HPLC by derivatization with p-bromophenacyl bromide. The pearmacokinetic parameters (AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$) were calculated and ANOVA was utilized for the statistical analysis of parameters. The apparent differences of these parameters between two drugs were less than 20% (i.e., 1.26,-5.08 and 8.59% for AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$, respectively). The powers (1-$\beta$) for AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$, and Tmax were over 0.9. Minimal detectable difference ($\Delta$) at $\alpha$=0.05, 1-$\beta$=0.8 were less than 20% (i.e.,7.31, 14.88 and 11.77% for AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$, respectively). The confidence intervals ($\delta$) for these parameters were also within $\pm$ 20% (i.e.,-3.03$\leq$$\delta$$\leq$5.54, -13.80$\leq$$\delta$$\leq$3.64 and 1.69$\leq$$\delta$$\leq$15.48 for AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$, respectively). These results satisfied the criteria of KFDA guideline for bioequivalence, indicating Carnitile bioequivalent to Nicetil $e^{R}$ .TEX>$^{R}$ .> R/ . R/ .

• Biomolecules & Therapeutics
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• v.14 no.1
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• pp.50-55
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• 2006

The objective of the study was to evaluate the bioequivalency between the $Rozid^{TM}$ Tablet (Ilhwa Pharm. Co., Ltd.) as a test formulation and the $Rulid^{TM}$ Tablet (Handok Pharm. Co., Ltd) as a reference formulation. Twenty-four healthy male volunteers were administered the formulations by the randomized Latin square crossover design, and the plasma samples were determined by a high performance liquid chromatography (HPLC) with fluorescence detector. $AUC_t,\;C_{max}\;and\;T_{max}$ were obtained from the time-plasma concentration curves, and log-transformed $AUC_t\;and\;C_{max}$ and log-untransformed $T_{max}$ values for two formulations were compared by statistical tests and analysis of variation. $AUC_t$ was determined to be $63.30{\pm}25.57{\mu}g.hr/ml$ for the test formulation and $64.02{\pm}29.27mg.hr/ml$ for the reference formulation. The mean values of $C_{max}$ for the test and reference formulations were $5.07{\pm}2.14\;and\;5.53{\pm}2.60{\mu}g/ml$, respectively. The $AUC_t,\;and\;C_{max}$ ratios of the test $Rozid^{TM}$ Tablet to the reference $Rulid^{TM}$ Tablet were -1.12% and -8.32%, respectively, showing that the mean differences were satisfied the acceptance criteria within 20%. The results from analysis of variance for log-transformed $AUC_t,\;and\;C_{max}$ indicated that sequence effects between groups were not exerted and 90% confidence limits of the mean differences for $AUC_t,\;and\;C_{max}$ were located in ranges from log 0.80 and log 1.25, satisfying the acceptance criteria of the KFDA bioequivalence. The RozidTM Tablet as the test formulation was considered to be bioequivalent to the RulidTM Tablet used as its reference formulation, based on $AUC_t,\;and\;C_{max}$ values.

• Journal of Pharmaceutical Investigation
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• v.28 no.4
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• pp.289-294
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• 1998

Bioequivalence of two aceclofenac tablets, the $Airtal^{TM}$ (Daewoong Pharmaceutical Co., Ltd.) and the $Senital^{TM}$ (Hana Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Fourteen normal male volunteers (age $20{\sim}29$ years old) were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 100 mg of aceclofenac was orally administered, blood was taken at predetermined time intervals and the concentration of aceclofenac in plasma was determined with an HPLC method using UV detector. The pharmacokinetic parameters ($C_{max}$, $T_{max}$ and $AUC_t$) were calculated and ANOVA was utilized for the statistical analysis of parameters. The results showed that the differences in $C_{max}$, $T_{max}$ and $AUC_t$ between two tablets were 3.69%, 2.44% and 0.51%, respectively. The powers $(1-{\beta})$ for $C_{max}$, $T_{max}$ and $AUC_t$ were 87.85%, 98.70% and more than 99%, respectively. Detectable differences $({\Delta})$ and confidence intervals were all less than ${\pm}20%$. All of these parameters met the criteria of KFDA for bioequivalence, indicating that $Senital^{TM}$ tablet is bioequivalent to $Airtal^{TM}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.36 no.4
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• pp.277-282
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• 2006

Lisinopril is one of the angiotensin-converting enzyme inhibitors, which have been used for treatment of hypertension and heart failure. The aim of this study was to evaluate the bioequivalence of two lisinopril tablet, $Lisihexal^{\circledR}$ and $Zestril^{\circledR}$ as a test and reference, respectively. The study was came out on 28 healthy male Korean volunteers in $2{\times}2$ crossover design. An analytical method with LC-MS-MS was developed for the quantification of lisinopril and enalapril(IS) using SPE method. The condition was selective, sensitive and precise in human plasma, that was enough for the pharmacokinetic study of lisinopril. The pharmacokinetic parameters such as $AUC_t,\;AUC_{inf},\;C_{max},\;T_{max}\;and\;t_{1/2}$ were calculated and ANOVA test was used for the statistical analysis of the parameters using log transformed $AUC_t,\;AUC_{inf}\;and\;C_{max}$. $t_{1/2}$ of test and reference drugs were calculated $11.4{\pm}5.1\;and\;16.1{\pm}9.9\;hr$, respectively. The 90% confidence intervals of $AUC_t,\;AUC_{inf}\;and\;C_{max}$ were log 0.9245$\sim$log 1.0603, log 0.9270$\sim$log 1.0601 and log 0.9548$\sim$log 1.1009, within the acceptable range of log 0.8 to log 1.25 by KFDA bioequivalence criteria. Two medications of lisinopril were evaluated bioequivalent and thus may be prescribed interchangeably.

• Korean Journal of Community Nutrition
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• v.20 no.4
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• pp.301-309
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• 2015

Objectives: While recent studies showed that coffee consumption reduced the risk of all-cause mortality, no study has examined the effect of coffee consumption on all-cause mortality related to sleep disorders. We aimed to examine whether sleep-related disorders would differently affect the association between coffee consumption and the risk of all-cause mortality among 8,075 adults aged 40 to 69 years. Methods: In a prospective cohort study, the study participants were biennially followed up for 12 years from 2001 to 2012. On each follow-up visit, the participants underwent comprehensive tests including anthropometric examinations, interviewer-administered questionnaires, and biochemical tests. Coffee consumption frequency and the amount were measured using a semi-quantitative food frequency questionnaire. Using death certificate data from Korean National Statistical Office, the vital status of each study participant was identified. Sleep-related disorders were examined with interviewer-administered questionnaires. We estimated Hazard ratios and the corresponding 95% confidence intervals from Cox Proportional Hazard models. Multivariable models were established after adjusting for center, total caloric intake, age, gender, body mass index, physical activity, education, smoking, drinking, hypertension, diabetes, total cholesterol, c-reactive protein, energy-adjusted food groups of refined grains, vegetables, fruits, meat, fish, and dairy. Results: Compared with those who had no coffee consumption, participants who had about three cups of coffee per day showed a reduced risk of all-cause mortality, after adjusting for covariates. Those who had a sleep-related disorder showed no significant effect of coffee consumption on the risk of all-cause mortality, whereas those who had no sleep-related disorders showed significantly reduced risk of all-cause mortality. Conclusions: Our findings suggested that approximately three cups of coffee per day would be beneficial to reduce the risk of all-cause mortality only among adults with no sleep-related disorders. Coffee consumption should be prudent for those with sleep-related symptoms.

• Korean Journal of Community Nutrition
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• v.13 no.1
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• pp.69-79
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• 2008

This study was designed to develop the strategy plans for the customer satisfaction on foodservice in the senior care facilities. For this, we examined the level of the customer satisfaction and foodservice quality. Additionally, the association between service quality, customer satisfaction, and social, psychological, physical factors of the aged were tested. Data from convenience samples from 3 senior care facilities were collected by using a questionnaire. Exploratory factor analyses were completed on 20 attributes for the food and service quality and 7 items for the social and psychological states of the aged, respectively. Cronbach's a was estimated for reliability, and Pearson correlation and multiple regression analysis were used for statistical analyses. The level of the satisfaction on foodservice was 4.01 of 5.0. The satisfaction on foodservice did not show the significant differences by gender, education level, BMI, and socio-psychological satisfaction. But the foodservice quality and the satisfaction showed significant difference by income and physical problem, and the goal of life of the eldely, respectively. Multiple regression analyses revealed that the determinants of the customer satisfaction on foodservice were the core quality of product, confidence, professionalism of employees and secondary quality of products. Especially, the kindness of employee is the most important attribute of the foodservice. Based on these results, we can set the strategy plans as follow: (1) the introduction of the foodservice evaluation system (2) the deployment of the event activities for offering fun to the customer (3) the continuous training of employees for ensuring the professional and kind service system, and (4) the introduction of selective menu system and take-out service of menu.

• Journal of Korean Society for Geospatial Information Science
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• v.12 no.2 s.29
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• pp.17-28
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• 2004

This study has tried to develop the modified DRASTIC Model by supplying the parameters, such as structural lineament density and land-use, into conventional DRASTIC model, and to predict the potential of groundwater contamination using GIS in Hwanam 2 District, Gyeonggi Province, Korea. Since the aquifers in Korea is generally through the joints of rock-mass in hydrogeological environment, lineament density affects to the behavior of groundwater and contaminated plumes directly, and land-use reflect the effect of point or non-point source of contamination indirectly. For the statistical analysis, lattice-layers of each parameter were generated, and then level of confidence was assessed by analyzing each correlation coefficient. Groundwater contamination potential map was achieved as a final result by comparing modified DRASTIC potential and the amount of pollutant load logically. The result suggest the predictability of contamination potential in a specified area in the respects of hydrogeological aspect and water quality.