• Journal of the Korean Data and Information Science Society
• /
• v.28 no.4
• /
• pp.743-754
• /
• 2017

Assessing bioequivalence between original drug and generic drug is traditionally based on $2{\times}2$ crossover design. As bioequivalence trials for highly variable drugs are getting popular, the required sample size based on $2{\times}2$ crossover design would be very large, which might cause the ethical concerns. Regulatory agencies like EMA and MFDS recommended higher order crossover designs such as $2{\times}4$, $4{\times}2$ and $4{\times}4$ crossover designs. Alternatively, a $2{\times}3$ dual design may be recommended in terms of economical and ethical points of view in comparison with the $2{\times}4$ crossover design for highly variable drug. In this study, we consider some statistical characteristics of $2{\times}3$ dual design and propose statistical procedures for calculating sample size and assessing bioequivalence based on $2{\times}3$ dual design. We also discuss the proposed procedures from the perspective of newly revised bioequivalence guidance issued by MFDS.

• Journal of the Institute of Electronics Engineers of Korea SC
• /
• v.49 no.1
• /
• pp.12-19
• /
• 2012

Recently, the market of skin-care device has been steadily growing up. In this paper, we tried to develop a personal compound stimulus device more competitive than existing products. As the compound stimulus, biochemical stimulus of herbal extraction fluid, thermal stimulus of plate-shaped carbon fiber heater, and optical stimulus of near infrared LED were selected. By some evaluation tests, the thermal stimulation part and the optical stimulation part were found to be developed properly. Additionally, the efficacy of the mixed stimulus of thermal and optical stimulation was tested in C2C12 mouse myoblast. Through RT-PCR analysis, it was found that, by the developed compound stimulus, the expression of collagen I mRNA and collagen III mRNA increased by 4.9 and 1.3 times respectively.

• Journal of the Korean Applied Science and Technology
• /
• v.36 no.3
• /
• pp.942-953
• /
• 2019

The objective of this study was to evaluate the effects of L-arginine supplementation on muscle damage and fatigue indices and athletic performance improvement of canoe athletes after conducting a high-intensity training program. To achieve the objective, this study applied a high-intensity training program to seven high school canoe athletes. The high-intensity training program is composed of aerobic exercise sessions (twice per week; Tuesday and Thursday), anaerobic exercise sessions (three times per week; Monday, Wednesday, and Friday), and flexibility exercise sessions (five times per week). During the 6 week high-intensity training program, drug ingestion (L-arginine or placebo) was conducted in the first two weeks, wash out (two weeks) followed it, and drug ingestion (L-arginine or placebo) was carried out again in the last two weeks. The crossover design was used for the experiment so all study subjects were assigned to either the L-arginine intake group (the treatment group) or the placebo group (the control group). Each subject ingested 3g per day. This study confirmed the significant effects of L-arginine supplementation on muscle damage indices, fatigue indices, and antioxidants using blood samples. Additionally, FMD was analyzed to evaluate vascular endothelial cell functions and canoe performance was examined using the canoe ergometer. The results of this study showed that L-arginine intake did not have direct effects on the levels of ammonia, IP, and CK. The level of LDH decreased significantly more in the ARG group than in the PLA group due to L-arginine supplementation. Moreover, L-arginine supplementation did not change total NO, d-ROMs, BAP, and FMD significantly. Lastly, the results of the 500m canoe ergometer, which was conducted to evaluate the canoe performance, revealed that L-arginine did not have direct effects on total time, stroke distance, and mean velocity. However, L-arginine supplementation significantly improved muscle damage indices, fatigue indices, antioxidants, FMD, and canoe performance. Therefore, it is believed that additional studies are needed for examining the potential effects of L-arginine supplementation athletic performance enhancement.

• The Journal of Korean Academy of Prosthodontics
• /
• v.48 no.2
• /
• pp.111-121
• /
• 2010

Purpose: This 3D-FEA study was performed to investigate the influence of marginal bone loss pattern around the implant to the stress distribution. Material and methods: From the right second premolar to the right second molar of the mandible was modeled according to the CT data of a dentate patient. Teeth were removed and an implant ($\Phi\;4.0{\times}10.0mm$) was placed in the first molar area. Twelve bone models were created; Studied bone loss conditions were horizontal bone loss and vertical bone loss, assumed bone loss patterns during biologic width formation, and pathologic vertical bone loss with or without cortification. Axial, buccolingual, and oblique force was applied independently to the center of the implant crown. The Maximum von Mises stress value and stress contour was observed and von Mises stresses at the measuring points were recorded. Results: The stress distribution patterns were similar in the non-resorption and horizontal resorption models, but differed from those in the vertical resorption models. Models assuming biologic width formation showed altered stress distribution, and weak bone to implant at the implant neck area seams accelerates stress generation. In case of vertical bone resorption, contact of cortical bone to the implant may positively affect the stress distribution.

• Korean Journal of Ecology and Environment
• /
• v.41 no.spc
• /
• pp.68-76
• /
• 2008

This study examined the inhibition effects of a freshwater bivalve (Unio douglasiae) and a submerged plant (Potamogeton crispus) on the cyanobacterial bloom (Oscillatoria sp.). The experiment were conducted in aquarium $(50cm{\times}65cm{\times}120cm)$ with lake sediments in the bottom of the aquarium in 10 cm thick. Before the experiments, artificial cyanobacterial bloom was induced with the addition of lake sediment and CB medium. Total 12 transparent acrylic cylinders (${\Phi}19cm$, height 40 cm) were placed in the aquarium, and within which bivalves and plants were placed in various conditions such as the control (C), plant addition (P:5 stems), mussel addition (U:2 individuals), and both mussel and plant addition (PU: the same quantity as used in each treatment). The experiment was conducted in triplicate during 7 days. pH, dissolved oxygen (DO), electric conductivity (EC), salinity, cyanobacterial cell density, chlorophyll-${\alpha}$ concentration, and mussel filtering rate were monitored daily. At the end of the experiment, total phosphorus (TP), total nitrogen (TN), and plant height and weight were measured. Overall, a large degree of cyanobacterial growth inhibition appeared in both P and U treatments, and the effect was highest in the U treatment, followed by P and PU. The combined treatment of both U and P did not show any synergic effects compared to the effect in separated treatment. In all enclosures of the treatments chlorophyll-${alpha}$ (Chl-${alpha}$) concentration decreased until 36 hours after the additions of the plants and mussels. In contrast, Chl-${alpha}$ concentrations increased in PU enclosures after 36 hours. The same trend was shown in the cell density of Oscillatoria. pH and DO gradually decreased until 120 and 144 hours, respectively, in the P and PU enclosures. TP concentration increased in the mussel enclosures (U and PU), while TN concentration largely decreased in the plant enclosures (P and PU). Our results suggest that applied bivalve (Unio) and submerged plant (Potamogeton) seemed to have a potential effect on the growth inhibition of cyanobacteria, but their combined application may have an antagonistic effect to diminish the degree of the inhibition.