• The Korean Journal of Applied Statistics
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• v.24 no.3
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• pp.495-503
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• 2011

When a patent of an innovative (brand-name) small-molecule drug expires, generic copies of the innovative drug may be marketed if their therapeutic equivalence to the innovative drug has been shown. The small-molecule drugs are considered therapeutically equivalent and can be used interchangeably if two drugs are shown to be pharmaceutically equivalent with identical active substance and bioequivalent with comparable pharmacokinetics in a crossover clinical trial. However, the therapeutic equivalence paradigm cannot be applied to biosimilars since the active ingredients of biosimilars are huge molecules with complex and heterogeneous structures, and these molecules are difficult to replicate in every detail. The European Medicine Agency(EMEA) has introduced a regulatory biosimilar pathway which mandates clinical trials to show therapeutic equivalence. In this paper, we discuss statistical considerations in the design and analysis of biosimilar cancer clinical trials.

• Communications for Statistical Applications and Methods
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• v.22 no.4
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• pp.389-399
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• 2015

It is important not to overcalculate sample sizes for clinical trials due to economic, ethical, and scientific reasons. Kang and Kim (2014) investigated the accuracy of a well-known sample size calculation formula based on the approximate power for continuous endpoints in equivalence trials, which has been widely used for Development of Biosimilar Products. They concluded that this formula is overly conservative and that sample size should be calculated based on an exact power. This paper extends these results to binary endpoints for three popular metrics: the risk difference, the log of the relative risk, and the log of the odds ratio. We conclude that the sample size formulae based on the approximate power for binary endpoints in equivalence trials are overly conservative. In many cases, sample sizes to achieve 80% power based on approximate powers have 90% exact power. We propose that sample size should be computed numerically based on the exact power.

• Journal of Advanced Marine Engineering and Technology
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• v.36 no.6
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• pp.774-779
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• 2012

MILD (Moderate and Intense Low Oxygen Dilution) combustion is a technology that uses the recirculation of combustion gas to increase thermal efficiency not only by keeping down the concentration of Nitric Oxides and temperature but also by uniformizing the internal temperature of the combustion furnace. This study is a trial to obtain MILD combustion characteristics by adjusting the equivalence ratio with the air flow rate in the conical combustor while keeping the fuel flow rate and measuring the exhaust gas of the combustion furnace.

• The Korean Journal of Applied Statistics
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• v.25 no.1
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• pp.125-138
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• 2012

Recent assessments of the biosimilarity of biologic products have received considerable global attention. A clinical trial should be conducted to assess the biosimilarity of a biosimilar product and a innovator biological product. In this paper we will describe several methods for the implementation of clinical trials and statistical analysis, a real international case and related international guidelines.

• Journal of Korean Neurosurgical Society
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• v.65 no.2
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• pp.315-324
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• 2022

Objective : The aim of this study was to verify the equivalence and effectiveness of the tablet-administered Korean Repeatable Battery for the Assessment of Neuropsychological Status (K-RBANS) for the prevention and early detection of dementia. Methods : Data from 88 psychiatry and neurology patient samples were examined to evaluate the equivalence between tablet and paper administrations of the K-RBANS using a non-randomly equivalent group design. We calculated the prediction scores of the tablet-administered K-RBANS based on demographics and covariate-test scores for focal tests using norm samples and tested format effects. In addition, we compared the receiver operating characteristic curves to confirm the effectiveness of the K-RBANS for preventing and detecting dementia. Results : In the analysis of raw scores, line orientation showed a significant difference (t=-2.94, p<0.001), and subtests showed small to large effect sizes (0.04-0.86) between paper- and tablet-administered K-RBANS. To investigate the format effect, we compared the predicted scaled scores of the tablet sample to the scaled scores of the norm sample. Consequently, a small effect size (d≤0.20) was observed in most of the subtests, except word list and story recall, which showed a medium effect size (d=0.21), while picture naming and subtests of delayed memory showed significant differences in the one-sample t-test. In addition, the area under the curve of the total scale index (TSI) (0.827; 95% confidence interval, 0.738-0.916) was higher than that of the five indices, ranging from 0.688 to 0.820. The sensitivity and specificity of TSI were 80% and 76%, respectively. Conclusion : The overall results of this study suggest that the tablet-administered K-RBANS showed significant equivalence to the norm sample, although some subtests showed format effects, and it may be used as a valid tool for the brief screening of patients with neuropsychological disorders in Korea.

• Communications for Statistical Applications and Methods
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• v.22 no.6
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• pp.605-613
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• 2015

A three-arm parallel design has been proposed to assess the biosimilarity between a biological product and a reference product using relative distance (Kang and Chow, 2013). The three-arm parallel design consists of two arms for the reference product and one arm for the biosimilar product. This paper extended the three-arm parallel design to a (k + 1)-arm parallel design composed of k (${\geq}3$) arms for the reference product and one arm for the biosimilar product. A new relative distance was defined based on Euclidean distance; consequently, a corresponding test procedure was developed based on asymptotic distribution. Type I error rates and powers were investigated both theoretically and empirically.

• Communications for Statistical Applications and Methods
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• v.19 no.1
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• pp.47-55
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• 2012

The newly revised bioequivalence guideline of Korea allows the add-on test since July 1, 2008 when the initial bioequivalence trial fails to show the equivalence of two drugs. The statistical model of the add-on test and its two stage testing procedures are discussed. Some statistical points of consistency test in the add-on test are considered and the issue on the sample size of add-on test is discussed. Some reasonable alternative like Japan's guideline for bioequivalence studies is recommended to secure the proper use of an add-on study through some simulation studies.

• The Korean Journal of Pain
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• v.34 no.3
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• pp.339-345
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• 2021

Background: Ultrasound-guided caudal epidural injection (CEI) is limited in that it cannot confirm drug distribution at the target site without fluoroscopy. We hypothesized that visualization of solution flow through the inter-laminar space of the lumbosacral spine using color Doppler ultrasound alone would allow for confirmation of drug distribution. Therefore, we aimed to prospectively evaluate the usefulness of this method by comparing the color Doppler image in the paramedian sagittal oblique view of the lumbosacral spine (LS-PSOV) with the distribution of the contrast medium observed during fluoroscopy. Methods: Sixty-five patients received a 10-mL CEI of solution containing contrast medium under ultrasound guidance. During injection, flow was observed in the LSPSOV using color Doppler ultrasonography, following which it was confirmed using fluoroscopy. The presence of contrast image at L5-S1 on fluoroscopy was defined as "successful CEI." We then calculated prediction accuracy for successful CEI using color Doppler ultrasonography in the LS-PSOV. We also investigated the correlation between the distribution levels measured via color Doppler and fluoroscopy. Results: Prediction accuracy with color Doppler ultrasonography was 96.9%. The sensitivity, specificity, positive predictive value, and negative predictive value were 96.7%, 100%, 100%, and 60.0%, respectively. In 52 of 65 patients (80%), the highest level at which contrast image was observed was the same for both color Doppler ultrasonography and fluoroscopy. Conclusions: Our findings demonstrate that color Doppler ultrasonography in the LS-PSOV is a new method for determining whether a drug solution reaches the lumbosacral region (i.e., the main target level) without the need for fluoroscopy.

• Journal of Aquaculture
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• v.17 no.2
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• pp.122-127
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• 2004

On protein equivalence base, fishmeal (FM) was replaced by lysine cell mass (LCM) in selected different diets in Korean rockfish, Sebastes schlegeli (Hilgendorf) Eight experimental diets were formulated to contain 100% FM (LC $M_{0}$), 90% FM+10% LCM (LC $M_{10}$),80% FM+20% LCM (LC $M_{20}$), 70% FM+30% LCM (LC $M_{30}$), 60% FM+40% LCM (LC $M_{40}$ ), 70% FH+30% LCM+lysine (LC $M_{+Lys}$), 60% FM+40% LCM+lysine (LC $M_{40+Lys}$), and 50% FM+50% LCM+lysine (LC $M_{50+Lys}$). Experimental individuals of the fish (12.6 g) were randomly fed on one of the experimental diets. After 6 weeks of feeding trial, weight gain (WG) and feed efficiency (FE) of fish fed LC $M_{0}$ diet was significantly (P〈0.05) higher than those of fish fed LC $M_{20}$, LC $M_{30}$, LC $M_{40}$ , LC $M_{30+Lys}$, LC $M_{40+Lys}$, and LC $M_{50+Lys}$ diets, however, there was no significant difference in WG of fish fed LC $M_{0}$ and LC $M_{10}$ diets. Supplementation of lysine has no effect on WG. There was no significant difference in condition factor (CF) of fish fed LC $M_{0}$, LC $M_{10}$ and LC $M_{20}$ diets. Hemoglobin (Hb) of fish fed LC $M_{0}$, LC $M_{10}$, LC $M_{20}$, LC $M_{30}$, LC $M_{40}$ , LC $M_{30+Lys}$, and LC $M_{40+Lys}$, diets were not significantly different from each other. No significant differences were observed in hematocrit (PCV) and hepatosomatic index (HSI) among all dietary treatments. Apparent digestibility of dry matter (ADM) and protein (ADP) of diets significantly decreased with increase in dietary LCM level, though there was no difference in ADM and ADP between LC $M_{0}$ and LC $M_{10}$. These results indicate that LCM could replace up to 10% of fishmeal in Korean rockfish diets.ish diets.iets.ish diets.s.ish diets.

• Korean Journal of School Psychology
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• v.9 no.3
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• pp.485-503
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• 2012

Academic engagement has been known as a strong predictor of students' cognitive and affective outcomes in an educational context. Despite increasing interest and theoretical usefulness of this construct, a few researchers seem to be interested in the validation of instruments to measure academic engagement for Korean students. Thus, this study would like to introduce one of academic scales widely used, UWES-S(Utrecht Work Engagement Scale-Student) (Schaufeli et al., 2002a: 2002b) and to validate the UWES-S for Korean college students. To validate the Korean version of the UWES-S, 651 college students (285 for Field Trial, 366 for Main Study) were used. The procedure is as follows. First, we used an integrated adaptation procedure to produce a Korean version of the UWES-S. Second, EFA(exploratory factor analyses) was applied to explore the factor structure of the UWES-S on the field trial data. Third, the psychometric properties of the UWES-S items were examined by graded response model(GRM). Also CFA(confirmatory factor analysis) was used to examine its internal construct validity for the data from the main study. Finally, the external validity of the UWES-S was scrutinized with the related variables such as academic motivation and satisfaction. As a result, the Korean version of the UWES-S with 13 items was accepted that the four items were excluded from its original version. Second, the internal validity was supported that the 3 factor CFA model(vigor, dedication, absorption) fit the data well. Third, we supported the partial mediation model that academic engagement played as a mediating variable between academic motivation(internal/external) and academic satisfaction. Finally, the differences between a validation of UWES-S for Korean college and high school students, the necessity of construct equivalence testing, and direction for future research of scale validating were discussed.