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

• Clinical and Experimental Reproductive Medicine
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• v.49 no.3
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• pp.196-201
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• 2022

Objective: This prospective consecutive study investigated the variation in sperm DNA fragmentation (SDF) in multiple semen samples from patients with cancer. Methods: Eighty-one patients with various cancers underwent multiple semen collections on 3 consecutive days for sperm cryopreservation prior to cancer treatment. A commercial Halosperm kit was used to measure SDF. Within- and between-subject coefficients of variation were estimated via random-effects analysis of variance to assess the consistency of semen parameters and SDF. Intraclass correlation coefficients (ICCs) were calculated to assess the magnitude of the between-subject component of variance relative to the total variance. Results: The volume of semen in the day-2 and day-3 samples was significantly lower compared with the day-1 sample. Most parameters showed high ICC values, suggesting that within-subject fluctuations were small relative to the between-subject variability. The highest ICC values were identified for the SDF (ICC, 0.68; 95% confidence interval [CI], 0.45-0.84) and semen volume (ICC, 0.67; 95% CI, 0.45-0.84). Conclusion: Our findings showed that repeated ejaculates from patients with cancer had stable SDF levels.

• Phonetics and Speech Sciences
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• v.4 no.4
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• pp.19-27
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• 2012

When two speakers read a text together, the produced speech has been shown to reduce a high degree of variability (e.g., pause duration and placement, and speech rate). This paper provides a quantitative analysis of speech rate variation exhibited in synchronous speech by examining the global and local patterns in two dialects of Mandarin Chinese (Taiwan and Shanghai). We analyzed the speech data in terms of mean speech rate and the reference of "Just Noticeable difference (JND)" within a subject and across subjects. Our findings show that speakers show lower and less variable speech rates when they read a text synchronously than when they read alone. This global pattern is observed consistently across speakers and dialects maintaining the unique local variation patterns of speech rate for each dialect. We conclude that paired speakers lower their speech rates and decrease the variability in order to ensure the synchrony of their speech.

• Proceedings of the KSRS Conference
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• v.2
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• pp.688-691
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• 2006

The current system of the East China Sea, a marginal sea in the northwest Pacific, has a seasonal variation. The Changjiang Diluted Water, Chinese coastal water in the East China Sea, has different seasonal paths. It flows southward along the Chinese coast within a narrow band in winter and does northeastward the Korea/Tsushima Strait in summer, which has been a subject to many researchers. In particular, low salinity in the South Sea of Korea in 1996 and 1998 was in discord with the Changjiang River discharge and the Changjiang Diluted Water seems to play an important role in occurrence of red tide in the South Sea of Korea in 1997 and on the contrary, disappearance in the next year. These facts suggested that the Changjiang Diluted Water does not flow along the same path in every summer. According to the analyses for path of the Changjiang Diluted Water using ocean color images by SeaWiFS and salinity observations by shipboard CTD in August for recent years, the Changjiang Diluted Water in summer flowed within the range of direction from southeastward to north-northeastward anticlockwise. However, the Changjiang Diluted Water flowed northeastward toward Jeju Island of Korea for the most part. It is necessary to examine the influence of major factors on path variability of the CDW in summer such as surface wind, the Changjiang River discharge and background current.

• Journal of radiological science and technology
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• v.20 no.1
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• pp.35-38
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• 1997

Scintigraphic measurement of gastric emptying time has been reported to be influenced by the variation in depth of radionuclide within the stomach. This study was designed to clarify whether a part of the variability in gastric emptying could be ascribed to a relationship between anterior image, the total anteroposterior Image and the tissue attenuation correction(geometric mean). A dual-head scintillation camera(ADAC, USA) was used to investigate effect of such changes. We were performed 16 normal subject gastric emptying studies with $^{99m}TC$ labelled scramble egg, milk and solid meal(610 Kcal, 300 g) The results are as follows; On anterior Image, $T_{1/2}$ emptying time was delayed by 5 min, 6.5%(range $3{\sim}18\;min,\;5{\sim}31.4%$) compared with the geometric mean. But there was no different gastric emptying time between the total anteroposterior image and geometric mean. Therefore, if will be useful to use the method of geometric mean or the total anteroposterior image to evaluate the gastric emptying time accurately.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.35 no.4
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• pp.1-9
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• 2012

Decisions on reliability screening rules and burn-in policies are determined based on the estimated reliability. The variability in a semiconductor manufacturing process does not only causes quality problems but it also makes reliability estimation more complicated. This study investigates the nonuniformity characteristics of integrated circuit reliability according to defect density distribution within a wafer and between wafers then develops optimal burn-in policy based on the estimated reliability. New reliability estimation model based on yield information is developed using a spatial stochastic process. Spatial defect density variation is reflected in the reliability estimation, and the defect densities of each die location are considered as input variables of the burn-in optimization. Reliability screening and optimal burn-in policy subject to the burn-in cost minimization is examined, and numerical experiments are conducted.

• Journal of Pharmacopuncture
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• v.11 no.1
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• pp.55-69
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• 2008

Objective : We investigated the effects of distilled Wild Ginseng Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Wild Ginseng Herbal Acupuncture on the balance of the autonomic nervous system. Method : We investigated the effects of distilled Wild Ginseng Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Wild Ginseng Herbal Acupuncture on the balance of the autonomic nervous system. 1 healthy volunteers consisted of 31 subjects in experiment(distilled Wild Ginseng Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 31 subjects in experiment group were injected distilled Wild Ginseng Herbal Acupuncture at $GB_{21}$(Kyonjong) and 30 subjects in control group were injected Normal Saline at $GB_{21}$(Kyonjong). except of 2 subjects(in control group) who can't be measured and 11 subjects(7 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 24 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t-test(in group) and Student t-test(between two groups) were used to verify the result. Result : 1. After distilled Wild Ginseng Herbal Acupuncture injection, Mean HRV is significantly low only for first 5 minute, SDNN is significantly high after 5 minute, Complexity is significantly low after 5 minute, HRV index is significantly high after 10 minute and pNN50 is significantly low after 5 minute. 2. SDNN of distilled Wild Ginseng Herbal Acupuncture Group significantly increased from 20minute to 25minute, and pNN50 of distilled Wild Ginseng Herbal Acupuncture Group significantly decreased from 10minute to 15minute and 20 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Wild Ginseng Herbal Acupuncture injection, Ln(TP), Ln(VLF) and Ln(LF) are significantly high after 5 minute, normalized LF is significantly high after 5 minute and normalized HF is significantly low after 5 minute. 4. Ln(TP) and Ln(VLF) of distilled Wild Ginseng Herbal Acupuncture Group significantly increased from 20minute to 25 minute compared with those of Normal Saline group. Conclusion : The results suggest that distilled Wild Ginseng Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system and sympathetic nervous system compared to Normal Saline within normal range.

• Phonetics and Speech Sciences
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• v.4 no.4
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• pp.139-146
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• 2012

This study was designed to examine comfort levels of pitch and loudness with target matching and their effects on electroglottographic (EGG) and acoustic measures. Twelve speakers, six males and six females, were instructed to produce /a/ sustained vowel for three seconds at a comfortable pitch and loudness level without any instruction and with a target matching procedure of either a certain f0 or SPL separately with visual and auditory feedback. The range of pitch for females and males were presented by progressing up and down randomly at intervals of 5Hz from 150 Hz to 310 Hz (total 33 frequency targets) and from 85 Hz to 190 Hz (total 22 frequency targets), respectively. The loudness levels were 65, 75, 85, 95 dB (total of four intensity targets) for both males and females. Subjective estimations of comfortable levels were obtained using a 10-point equal-appearing interval rating scale following each phonation. The results showed that males and females demonstrated similar trends in loudness levels with greatest comfort at 75 dB, whereas pitch comfort ratings showed a greater variability with females having a wider range with target matching. In the comfort levels of individuals, most male and female speakers rated higher comfort at soft, rather than loud phonations. On the other hand, most male speakers perceived highest comfort levels below the comfort pitch levels they phonated under natural conditions. Higher frequency ranges, however, were perceived to be more comfortable than those of natural condition in most female speakers, although the comfortable pitch levels in spontaneous phonations were within the comfort level ranges determined by targeted phonations. When comparing acoustic (%jitter, %shimmer, SNR) and EGG measures (CQ%) between spontaneous comfortable phonations and targeted phonations produced by the same subject at similar f0 and intensity, no significant differences were observed (p>0.05). Thus, target matching procedures may be considered a compatible and alternative method to reduce the variability of comfortable pitch and loudness levels by eliciting consistent comfortable phonations.

• Korean Journal of Applied Biomechanics
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• v.19 no.3
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• pp.489-497
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• 2009

The purpose of this study was to find differences of jumping performances within individual and to identify the influencing factors in these differences. 20 male subjects performed 6 maximal vertical jumps. The best(GP) & worst(BP) performance of each subject based on their jump height were compared in further analysis. There was a significant difference of approx. 10% in the jump height between GP and BP, which resulted from height of COM and vertical velocity at the instant of take-off. We could observe a significantly higher ankle moment in the GB more than the BP but no significant differences for the knee and hip joint. Also the maximum power of ankle joints in the GP were significantly higher than that in the BP. According to the results, the mechanical output of knee and hip joint are not as influential as that of ankle joint for difference of performance within individual. In conclusion, the results showed that mechanical output of the ankle joint could be more influential factors on the performances within individual although the knee and hip joint play an important role in the vertical jump. We therefore propose that more emphasis should be placed on the potentiation of the ankle joint for the training of the maximum vertical jump.

• Child Health Nursing Research
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• v.3 no.1
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• pp.42-51
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• 1997

Although a family-centered approach to health care for developmentally disabled children has been advocated, existing systems of care have not adequately addressed the support needs of the family system and the essential role that parents play in the daily care of these children. The overall purpose of this research is to examine family system adaptation to the care of a developmetally disabled child using the Resiliency Model of Family Stress, Adjustement, and Adaptation Framework. Relationships among family system demands (stressors, strains, transitions, child's illness factors) and family system strengths and capabilities(resource of social support) were examined to determine their separate and combined contribution to explanining the variability in family system outcomes (family system coping ). The subject for this study was 46 families who have a child with developmental disabilities(mental retardation and / or autism) from three special educational programs in Seoul, Korea. Results from correlation and hierachial regression analysis revealed that perceived social support operated as a resiliency factor between family stress and coping. Child and family characteristics appeared to be important predictors of perceived social support and coping. In summary, there is evidence that the resource of social support as a family strength and capability was found to improve the family coping. These findings also must be viewed within the context that sample of families of children with disabilities was relatively small and eligible families from support group of special educational program.