• Korean Journal of Clinical Pharmacy
• /
• v.19 no.1
• /
• pp.50-60
• /
• 2009

Highly variable drugs (within-subject variability greater than 30%) have been difficult to meet current regulatory acceptance criteria using a reasonable number of study subjects. In this study, we reviewed previous studies presenting alternative approaches for bioequivalence evaluation of highly variable drugs, and focused on an approach for widening the bioequivalence acceptance limits using within-subject variability. We discussed the suggested five solutions for highly variable drug including the deletion of $C_{max}$ of the bioequivalence criteria, direct expansion of bioequivalence limit, multiple dose studies in steady state, bioequivalence assessment on the metabolite, add-on study, and widening the bioequivalence acceptance limits based on reference variability. The methods for widening of bioequivalence limits based on reference variability are scaled average bioequivalence containing within-subject variability on reference drug (${\sigma}_{WR}$), population bioequivalence derived from total variability on reference drug (${\sigma}_{TR}$) and test drug (${\sigma}_{TT}$), and individual bioequivalence derived from subject by formulation interaction variability (${\sigma}_D$) and within subject variability on reference drug (${\sigma}_{WR}$) and test drug (${\sigma}_{TR}$). To apply these methods, the switching variability (${\sigma}_0$) will have to be set by the regulatory authorities. The proposals of bioequivalence evaluation approach for the highly variable in Korea are presented for both of new drug and reevaluation drug.

• Journal of Korean Institute of Industrial Engineers
• /
• v.42 no.4
• /
• pp.290-295
• /
• 2016

This paper proposes a new method for the automatic detection of atrial fibrillation (AF), using Markov regime switching GARCH (1, 1) model. The proposed method is based on the observation that variability patterns of heart rate intervals during AF significantly differ from regular patterns. The proposed method captures the different patterns of heart rate intervals between two regimes : normal and AF states. We test the proposed method using Massachusetts Institute of Technology-Beth Israel Hospital (MIT-BIH) atrial fibrillation database, and demonstrate the effectiveness of the proposed method.

• Korean Journal of Optics and Photonics
• /
• v.27 no.6
• /
• pp.212-217
• /
• 2016

In connection-oriented data-transport services, data loss can occur when the service experiences a problem on its end-to-end path. To promptly resolve this problem, the data-switching systems providing the service should quickly modify their internal configurations distributed among different places in each system. This is performed through a sequence of problem (event) recognition, sharing, and handling procedures among multiple control processors in the system. This paper proposes a method for event sharing and messaging between control processors, to improve the time determinacy of event processing. This method simplifies runtime event sharing and minimizes the time variability caused by the event data, resulting in a decrease in the latency time in processing global events. The proposed method lessens the latency time of global event processing by about 40%, compared to general methods, for 738 internal path changes.

• East Asian mathematical journal
• /
• v.32 no.2
• /
• pp.217-232
• /
• 2016

The purpose of this study is to investigate the assessment expertise of Mathematics' teachers, focusing on the competence in designing assessment item development. In this present research, I analysed how the teachers' competence appears in designing assessment items development when they generated problems the given problem into a new one. To examine this assumption, the following research questions were posed and investigated in the present study : How do Pre-service and In-service Teachers in primary schools develop the assessment item when generating problems the given problems into new problems? The result from the case study of metamorphosing the given problem into a new problem teachers used similar patterns switching numbers or changing units in order to develop new problems. Also, teachers in primary schools tend to develop problems as commonly as in the mathematics workbooks. In-service teachers tend to have better skills developing assessment items, but there were quite much of variability between individuals.

• KSCE Journal of Civil and Environmental Engineering Research
• /
• v.30 no.5B
• /
• pp.471-477
• /
• 2010

In this study, the variability of the Horton index which is ratio of vaporization and wetting water is investigated using a conceptual soil water balance model. From the proposed model, the steady-state soil water probabilistic density function is derived through meteorological and watershed characteristics and then the sensitivity of Horton index to the precipitation occurrence rate and the mean of wet day precipitation is examined. As a result, the inter-annual variability of the Horton index is lower than that of precipitation and they showed the strong negative correlation. It is also shown that although precipitation is not varied, the Horton index can be varied due to the fluctuation of the precipitation occurrence rate and the mean of wet day precipitation. In addition, it is presented that there is a non-linear relationship which has a critical point switching proportional or inverse relationship between the Horton index and two main characteristics of precipitation process.

• Journal of Life Science
• /
• v.33 no.8
• /
• pp.639-650
• /
• 2023

The levels of harmful components in aerosols from heated tobacco products (HTPs) have been reported to be significantly lower than in cigarette smoke. However, it remains unclear whether the use of HTPs can mitigate the cardiovascular risks associated with cigarette smoking (CS). The objective of this study was to investigate the effects of a short-term switch from CS to HTP use on cardiac autonomic regulation (CAR). Seven healthy male smokers completed an open-label, randomized, cross-over trial consisting of five days of CS, use of three different HTPs (IQOS use, IQ; lil SOLID use, LS; lil HYBRID use, LH), or non-smoking (NS). Each session was separated by a one-week washout period, and levels of exhaled carbon monoxide (CO) and carboxyhemoglobin (COHb), systolic (SBP) and diastolic blood pressure (DBP), and heart rate variability (HRV) reflecting CAR were assessed before use of the product assigned to each session and at 24, 48, 72, 96, and 120 hr after use. Levels of exhaled CO and COHb were statistically significantly reduced only during NS. There were no statistical changes in SBP and DBP within any session. However, in HRV spectral analysis, log-transformed high frequency (lnHF) increased statistically significantly in IQ, LS, and NS, respectively. Normalized HF (HFnu) was significantly increased in NS and LH, respectively. lnHF and HFnu showed significant interaction effects. The findings of this study suggest that a short-term switch to HTPs instead of CS may lead to different distribution patterns of CAR, primarily driven by enhanced cardiac vagal tone.

• Journal of Environmental Science International
• /
• v.13 no.5
• /
• pp.479-488
• /
• 2004

Five sediment cores from the tidal flat of artificial Lake Shihwa are analyzed in terms of sedimentology and geochemistry to evaluate the heavy metal contamination and redox condition of surficial sediment following the Shihwa seawall construction. The variability of concentrations of various elements depends on the depositional environment, and reflects the various redox conditions and sediment provenances. The amounts of Ti and Al and their ratio of Ti/ Al with respect to Li clearly indicate that there is an anthropogenic contribution to the surficial sediment. The high concentrations of heavy metals suggest an anthropogenic contribution at ST. 34 and ST. 22. Concentrations of most elements (Cr, Cu, Zn and Pb) are higher near the Shihwa-Banwol industrial complex than in the central part of Lake Shihwa. Concentrations of heavy metal in surficial sediment near the Shihwa-Banwol industrial complex are two to eight times higher than in the center of Lake Shihwa. Enrichment factors (EF), which are normalized by the unpolluted shale, suggests a significant metallic contamination near the Shihwa-Banwol industrial complex (SBIC). The redox condition is divided into two anoxic and mixed oxi $c_oxic zones based on the carbon:sulfur (C/S) ratios of organic matter and elemental relationships. Correlations among geochemical elements Mn, U and Mo are significantly different from site to site, and may therefore be an indicator of the spatial redox condition. Controlling factors for switching anoxic/oxic conditions are thought to be water depth and the differences in industrial effluent supply. The variations of the Cu/Mn ratio in the sediments confirms above mentioned spatial differences of a redox condition in part, and therefore shows a location-dependence redox condition in sediments at four other sites. The redox condition of the surficial sediment characteristics of the Shihwa Lake are controlled by its geographic location and water depth.th.

• Journal of the Korean Physical Society
• /
• v.73 no.12
• /
• pp.1821-1826
• /
• 2018

Uniformity is a key feature of state-of-the-art infrared focal planed array (IRFPA) and infrared imaging system. Unlike traditional infrared telescope facility, a ground-based infrared radiant characteristics measurement system with an IRFPA not only provides a series of high signal-to-noise ratio (SNR) infrared image but also ensures the validity of radiant measurement data. Normally, a long integration time tends to produce a high SNR infrared image for infrared radiant characteristics radiometry system. In view of the variability of and uncertainty in the measured target's energy, the operation of switching the integration time and attenuators usually guarantees the guality of the infrared radiation measurement data obtainted during the infrared radiant characteristics radiometry process. Non-uniformity correction (NUC) coefficients in a given integration time are often applied to a specified integration time. If the integration time is switched, the SNR for the infrared imaging will degenerate rapidly. Considering the effect of the SNR for the infrared image and the infrared radiant characteristics radiometry above, we propose a-wide-dynamic-range NUC algorithm. In addition, this essasy derives and establishes the mathematical modal of the algorithm in detail. Then, we conduct verification experiments by using a ground-based MWIR(Mid-wave Infared) radiant characteristics radiometry system with an Ø400 mm aperture. The experimental results obtained using the proposed algorithm and the traditional algorithm for different integration time are compared. The statistical data shows that the average non-uniformity for the proposed algorithm decreased from 0.77% to 0.21% at 2.5 ms and from 1.33% to 0.26% at 5.5 ms. The testing results demonstrate that the usage of suggested algorithm can improve infrared imaging quality and radiation measurement accuracy.

• Journal of Mushroom
• /
• v.2 no.3
• /
• pp.115-126
• /
• 2004

Somatic hybrids of inter-compatible and inter-incompatible strains were obtained by protoplast fusion. The fusion products between compatible strains, Pleurotus ostreatus and P. florida, formed heterokaryons, while fusants between incompatible strains such as P. cornucopiae + P. florida, P. ostreatus + Ganoderma applanatum, P. florida + Ganoderma lucidum, and P. ostreatus + Flammulina velutipes formed synkaryons that retained genes from both parents. The heterokaryons showed the same level of basidioma development. In contrast, the synkaryons showed unique characteristics including clamp connection formation at mitosis, either partner basidioma development, and abnormal segregation and recombination compared with inter-compatible strains. Synkaryons can be classified into homokaryoyic and heterokaryotic type. A comparison of somatic hybrids with compatible and incompatible strains was made using random amplified polymorphic DNA (RAPD) analysis. The heterokaryons between compatible species showed the same level of variability and contained both parental RAPD bands. In contrast, most of the synkaryons between incompatible species showed similarity to those of either parental bands and non-parental RAPD bands. Synkaryons can be classified into microgenome insertion type and macrogenome insertion type. A tetrapolar mating system was found among monospore isolates in somatic hybrids and wild type P. ostreatus. Homokaryons from each somatic hybrid combination were paired with tester homokaryons of the initial wild type of P. ostreatus. The changed mating types were identified in progenies. The pattern of mating type switching in somatic hybrids depends on compatibility of fusion partner. There are several factors related to the mechanism of clamp connection formation and fruiting body development of synkaryons. Of these,the major factor may be associated with self-fertility and mating type switching such as homokaryotic fruiting of wild type P. ostreatus. This review will discuss these aspects.