• Title/Summary/Keyword: reference interval

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Bioequivalence Study of Loxoprofen Sodium in healthy Volunteers (Loxoprofen sodium 제제(레녹스정)의 생물학적 동등성시험)

  • 최주영;유내춘;박민수;김경환
    • Biomolecules & Therapeutics
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    • v.6 no.4
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    • pp.417-422
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    • 1998
  • Loxoprofen sodium (sodium 2-[4-(2-oxocyclopentylmethyl)phenyl] propionate dehydrate) is a nonsteroidal antiinflammatory drug of $\alpha$-phenyl propionic acid derivative. To test the bioequivalence of loxoprofen, the pharmacokinetic parameters of new preparation of loxoprofen, LENOX was compared with LOXONIN as a reference drug. Fourteen healthy volunteers were entered to the stydy (Yonsei University College of Medicine, Severance Hospital IRB approval No. 9608). They were administered 60 mg of loxoprofen in 2$\times$2 cross-over design. There was one week of drug-free interval between doses. The blood sample was taken on schedule up to 8 hours, and the plasma concentration loxoprofen was measured by reverse phase high-performance liquid chromatography (HPLC) with UV-detector. There were no significant difference between two preparations when AUC, Cmax, and Tmax were compared by ANOVA. The mean differences of AUC, Cmax, and Tmax were within 20% of the reference drug: the values were 2.22,5.61, and 12.50%, respectively. The confidence limits of AUC and Cmax but not Tmax satisfied the bioequivalence criteria. These results suggest that the tested LENOX is bioequivalent to the reference drug.

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A Collaborative Study to Establish the Second Korean National Reference Standard for Snake Venom

  • Han, Kiwon;Jung, Kikyung;Oh, Hokyung;Song, Hojin;Park, Sangmi;Kim, Ji-Hye;Min, Garam;Lee, Byung-Hwa;Nam, Hyun-sik;Kim, Yang Jin;Ato, Manabu;Jeong, Jayoung;Ahn, Chiyoung
    • Toxicological Research
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    • v.34 no.3
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    • pp.191-197
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    • 2018
  • In 2015, a candidate for the second national reference standard (NRS) of Gloydius snake venom was produced to replace the first NRS of Gloydius snake venom. In the present study, the potencies of the candidate were determined by a collaborative study, and the qualification of the candidate was estimated. The potencies of the candidate were determined by measuring the murine lethal titers and lapine hemorrhagic titers of venom against the regional working reference standard (RWRS) for antivenom using the methods described in the previous report for the first NRS of Gloydius snake venom. Three Korean facilities contributed data from a total of 30 independent assays. Subsequently, two foreign national control research laboratories contributed to this collaborative study. The results were calculated using the Reed-Muench method for lethality and determined using a mixed-effects model for hemorrhage. The general common potencies of the lethal and hemorrhagic titers were obtained from the results of the 30 tests performed at three Korean facilities. The results are expressed in micrograms for 1 test dose (TD) with a 95% confidence interval as follows: a lethal titer of $90.13{\mu}g/TD$ (95% confidence interval = $87.39{\sim}92.86{\mu}g$) and a hemorrhagic titer of $10.80{\mu}g/TD$ (95% confidence interval = $10.46{\sim}11.14{\mu}g$). In addition, the candidate preparation showed good quality evaluation according to the results of the quality estimation of the candidate and is judged to be suitable to serve as the Korean NRS for snake venom. In conclusion, the second NRS of Gloydius snake venom was established in this study and will be used for national quality control, including a national lot release test of Korean antivenom products.

Damage of Ibuprofen Suppository on Rectal Mucosa of Rats (이부프로펜 좌제의 흰쥐 직장점막 자극성 시험)

  • Lee, Sung-Hack;Kim, Moon-Kyoung;Han, Yong-Hae;Shim, Chang-Koo
    • Journal of Pharmaceutical Investigation
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    • v.24 no.3
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    • pp.115-129
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    • 1994
  • In the present study, quantitative and qualitative histology was used to assess the effects of ibuprofen suppositories with various treatments on the rectal mucosa of rats. Two suppositories were prepared with Witepsol W35 and compared with two commercial ibuprofen suppositories Reference I (Showa Pharm.ind., Tokyo, Japan), Reference II (P.Pharm., Seoul, Korea). Single and multiple dose(dosing interval 4 hr, n=4) studies were conducted. All suppositories significantly increased epithelial cell loss, but the extent of rectal irritation was variable. These studies showed that the incorporation of ibuprofen into the suppository bases increases the morphological change in rectal tissue both for the single and multiple administrations of suppositories, but which was significantly recovered within 24 hr although the interanimal variability in scores was very substantial. Multiple administration of ibuprofen suppositories caused significant damage to rectal mucosa, but it must be considered that these were under the severe condition, that is, interval of administration (4 hr) was three times shorter than normal interval of administration and dose was fifteen times larger than usual human dose. Aluminum oxide $(Al_2O_3)$, a dispersing agent, slightly increased the irritation of rectal mucosa in rats at 5 hr and 24 hr after multiple administration, but it was possible to ignore the difference of irritation in the data at 5hr and 24hr after single administration. Finally, it was concluded that Witepsol W35 and ibuprofen had a slight rectal mucosa-irritating effect on the usual human dose, and ibuprofen suppositories prepared with Witepsol W35 or Witepsol W35, $Al_2O_3$ showed almost similar extent of rectal irritation with commercial ibuprofen products.

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The Role of Heart Rate Recovery: Possibility of Heart Disease and Exercise Program Application (회복 시 심박수의 역할: 심장질환과 운동프로그램 적용 가능성)

  • Lee, Hae Sung;Kim, Jong-Hee
    • Journal of Animal Reproduction and Biotechnology
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    • v.34 no.3
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    • pp.166-172
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    • 2019
  • Heart rate is a relatively simple and non-invasive method that is used as an important physiological indicator in many studies and has a close relationship with heart structure and function, cardiovascular disease and sudden cardiac death. In general, appropriately low heart rate during resting means effective heart function and cardiovascular fitness; heart rate at recovery is an important indicator of health and disease condition. We found a beagle dog (Dog_1) with a high heart rate in the previous preliminary experiment. Therefore, purpose of this study was to compare the heart rate response of the Dog_1 with the control group during 12 weeks of interval exercise, to evaluate the structural and functional abnormalities of the heart and to verify the applicability of exercise program. Heart rate was checked during 12 weeks of interval exercise, and after the exercise was over, imaging examination and hematological and serum biochemistry were performed. As a result, Dog_1 (165.6 ± 1.5) showed significantly higher heart rate in low intensity session of interval exercise than control group (133.3 ± 0.5, p < 0.01). In addition, Dog_1 (181.2 ± 1.4) showed significantly higher heart rate than control group (155.1 ± 0.9) in high intensity session (p < 0.01). The heart rate (30 sec, 60 sec) during recovery state was higher in Dog_1 (30 sec: 156.8 ± 4.0, 60 sec: 166.8 ± 5.8) than in the control group (30 sec: 111.2 ± 2.5, 60 sec: 104.0 ± 5.1, p < 0.01). The results of the imaging examination of Dog_1 with high heart rate confirmed that the heart had no functional and structural abnormalities. All beagles with the interval exercise program did not show maladjustment, and in the hematological and serum biochemistry results, all the parameter were within the reference range. If the interval exercise program of this study is used in the future, it is expected to be used as an important basic data to achieve the purpose of health, welfare, and physical fitness improvement of dogs.

The Apparel Sizing System of Early Adolescent Girls - Focusing on Lower Garments - (청소년 전기 여학생의 하의 치수 규격에 관한 연구)

  • Jeong, Hwa-Yeon;Suh, Mi-A
    • The Research Journal of the Costume Culture
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    • v.13 no.5 s.58
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    • pp.671-685
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    • 2005
  • The purpose of this study was to develop a new size range and size interval for early adolescent girls. For this purpose, a total of 529 girls aged between 10 and 14 were measured and data were collected from 42 anthropometric measurements and 41 photographic measurements per a person. SAS 8.1 was used in data analysis including means, standard deviations, and frequency analysis. The stature was divided at 5cm intervals as in KS into 9 sizes from the lowest 130cm to the highest 171cm. If waist circumference were divided at the same intervals, the sizes cannot reflect the body growth of adolescent girls at these ages. Thus this study set intervals between sizes irregularly based on the mean of waist circumference by the type of body shape. Based on the results, this study proposed: for Type A - 6 sizes (140A-58, 145A-54, 145A-62, 150A-58, 150A-62, 155A-62); for Type X- 9 sizes (150X-59, 155X-63, 155X-66, 160X-59, 160X-63, 160X-66, 165X-59, 165X-63, 165X-66): and for Type H - 7 sizes (145H-68, 150H-68, 150H-70, 155H-68, 155H-73, 160H-68, 160H-73). For the sizes selected for each type, reference measurements were decided - centering on items necessary for manufacturing clothes. Reference measurements suggested for lower garments 8 items including waist circumference, hip circumference, slacks length and crotch length. The suggested sizes are distributed in a wider range, so they are considered to be helpful for students to find clothes fitting their bodies.

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Computerized bone age estimation system based on China-05 standard

  • Yin, Chuangao;Zhang, Miao;Wang, Chang;Lin, Huihui;Li, Gengwu;Zhu, Lichun;Fei, Weimin;Wang, Xiaoyu
    • Advances in nano research
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    • v.12 no.2
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    • pp.197-212
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    • 2022
  • The purpose of this study is to develop an automatic software system for bone age evaluation and to evaluate its accuracy in testing and feasibility in clinical practice. 20394 left-hand radiographs of healthy children (2-18 years old) were collected from China Skeletal Development Survey data of 1998 and China Skeletal Development Survey data of 2005. Three experienced radiologists and China-05 standard maker jointly evaluate the stages of bone development and the reference bone age was determined by consensus. 1020 from 20394 radiographs were picked randomly as test set and the remaining 19374 radiographs as training set and validation set. Accuracy of the automatic software system for bone age assessment is evaluated in test set and two clinical test sets. Compared with the reference standard, the automatic software system based on RUS-CHN for bone age assessment has a 0.04 years old mean difference, ±0.40 years old in 95% confidence interval by single reading, a 85.6% percentage agreement of ratings, a 93.7% bone age accuracy rate, 0.17 years old of MAD, 0.29 years old of RMS; Compared with the reference standard, the automatic software system based on TW3-C RUS has a 0.04 years old mean difference, a ±0.38 years old in 95% confidence interval by single reading, a 90.9% percentage agreement of ratings, a 93.2% bone age accuracy rate, a 0.16 years of MAD, and a 0.28 years of RMS. Automatic software system, AI-China-05 showed reliably accuracy in bone age estimation and steady determination in different clinical test sets.

Method of Generating Information Signals in the System Industrial Internet of Things

  • Aleksandr Serkov;Nina Kuchuk;Bogdan Lazurenko;Alla Horiuskina
    • International Journal of Computer Science & Network Security
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    • v.24 no.4
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    • pp.206-210
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    • 2024
  • Industrial facilities that use modern IT technologies require the ensured reliability and security of information in automated enterprise management. Concurrently, so as to ensure a high quality of communication, it is necessary to expand the bandwidth of communication channels, which are limited by the physical parameters of the radio frequency spectrum. In order to overcome this contradiction, we propose the application of technology fundamental to ultra-wideband signals, in which the ratio between the bandwidth and its central part is greater than "one". For this reason, the information signal is emitted without a carrier frequency - simultaneously within the entire frequency band - provided that the signal level is lower than the noise level. For the transmission of information content, the method of positional-time coding is used, in which each information bit is encoded by hundreds of ultrashort pulses that arrive within a certain sequence. Mathematical models of signals and values observed in wireless communication systems with autocorrelation reception of modulated ultra-wideband signals are furthermore recommended. These assist in identifying features of the dependence of the error probability on the normalized signal-to-noise ratio and the signal base. Comparative analysis has shown that the best noise immunity of the systems considered in this paper is the communication system, which uses the time separation of the reference and information signals. During the first half of the bit interval, the switch closes the output of the transmitter directly to the generator of the ultra-wideband signal - forming a reference signal. In the middle of the bit interval, the switch alternates the output to one of two possible positions depending on the encoding signal - "zero" or "one", forming the information part of the ultra-wideband signal. It should also be noted that systems with autocorrelation reception and separate transmission of reference and information signals, provide a high level of structural signal secrecy. Furthermore, they provide the reliable transmission of digital information, especially in interference conditions.

Bioavailability Evaluation of Two Ceftriaxone Formulations Using Two Way Crossover Design in Voluteers

  • Kwon, Kwang-Il;Bok, Soo-Jin;Kim, Moo-Heon;Lee, Chang-Hyun
    • Archives of Pharmacal Research
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    • v.18 no.4
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    • pp.237-242
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    • 1995
  • For the vioequivalence study of two ceftriaxone injection formulations ($Rocephin{\circledR}$ ; Roche, and Triaxone ; Hanmi0, the HPLC analytical method for the analysis of ceftriaxone in plasma was used. Fourteen healthy volunteers completed the study and each subject were IM in jected signle doses (1 g) of the test and the reference formulations in a two-way crossover design with an one week drug free interval between doses. Following each administration, plasma concentrations of ceftrixone were monitored over a period of 24 h. Bioequivalence parameters $AUC_{24th}, {\;}T_{max}, {\;}C_{max}$ and MRT determined from the data obtained for the two formulations were examined by analyses of variance (ANOVA) and other criteria and tests for bioequivalence. Results of ANOVA and confidence limits of test/reference ratios of $AUC_{24th}, {\;}T_{max}, {\;}C_{max}$ and MRT, and statistical tests indicated the bioequivalence of the two formulations (i.e., test/reference ratio was within $100{\pm}20%$) except for $T_{max}$ The mean of $T_{max}$ showed only 6. 9% difference from the reference but the detection limit was 22.5% which is slightly over the 20% criteria. No pharmacokinetic parameters including Ka, Kel, Vd and Cl indicated significant difference in between the two fomulations. It was concluded that the data yielded fro the two cefriaxone formulations demonstrated that they were bioequivalent.

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Geoid Height Estimation Using Rail-road Reference Points (철도기준점을 활용한 지오이드고의 추정)

  • Heo, Joon;Song, Yeong-Sun;Kim, Sung-hoon;Moon, Cheung-Kyun
    • Journal of the Korean Society for Railway
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    • v.12 no.4
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    • pp.499-505
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    • 2009
  • This paper evaluated applicability of railroad reference points for determinating geoid heights. For this research, reference points on the Honam express raildroad which contain ellipsoid heights estimated by GPS/Leveling and orthometric heights by leveling were used. Geoid heights were calculated uisng orthometric and ellipsoid heights of 360 railroad reference points, and the RMSE's with respect to different intervals of reference points were analysed which were induced by interpolation methods. The results showed that no significant difference of RMSE's among interpolation. methods. RMSE's of 0-4km interval of reference points were determined within 2cm and 5-8km were within 3cm. Also, this research confirmed that GPS leveling with Geoid model is not auurate enough to be used for railroad surveying as yet.

Analysis of Factors Related to Mortality in Adult ICU Patients: Focusing on Nurse Staffing Level (성인중환자실 이용 환자의 사망률 관련 요인 분석: 간호등급을 중심으로)

  • Lee, Jeong Mo;Lee, Kwang Ok;Hong, Jeong Hwa;Park, Hyun Hee
    • Journal of muscle and joint health
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    • v.29 no.1
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    • pp.41-49
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    • 2022
  • Purpose: The purpose of this study was to assess the influence of nurses staffing level on patient health outcomes in intensive care units (ICUs) in Korea. Methods: The study was retrospective in nature. Information on patients and their outcomes, as well as nurse cohort data, were obtained from Korea's National Health Insurance Service Database. The observation period was from January 1, 2008 to December 31, 2018, and data for 2,964,991 patients were analyzed. Independent variables included patient' age and sex and hospital type, intensivist, and nurses staffing level. Results: The mortality rate in ICUs was significantly higher at tertiary hospitals with a level 3~4 (HR, 1.21; 95% confidence interval, 1.19~1.22) or level 5~9 nurse staffing (HR, 1.31; 95% confidence interval, 1.27~1.34) compare to that of tertiary hospitals with a 1~2 level. 28-day mortality rate was also higher at general hospitals with a level 3~4 (HR, 1.13; 95% confidence interval, 1.12~1.14), level 5~6 (HR. 1.34; 95% confidence interval, 1.32~1.36), level 7~9 nurse staffing (HR, 1.38; 95% confidence interval, 1.38~1.42), using level 1~2 as reference. Conclusion: Nurses staffing level is a key determinant of healthcare-associated mortality in critically ICUs patients. Policies to achieve adequate nurse staffing levels are therefore required to enhance patient outcomes.