• Title/Summary/Keyword: selective criteria

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Bioequivalence of LG Cilostazol Tablet to Pletaal Tablet (Cilostazol 100 mg) (프레탈 정(실로스타졸 100 mg)에 대한 엘지실로스타졸 정의 생물학적 동등성)

  • Cho, Hea-Young;Lim, Dong-Koo;Shin, Sang-Chul;Moon, Jai-Dong;Lee, Yong-Bok
    • Korean Journal of Clinical Pharmacy
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    • v.11 no.1
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    • pp.7-12
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    • 2001
  • Cilostazol has both antithrombotic and cerebral vasodilating effects, and one of the mechanism is the selective inhibition of platalet cyclic AMP phosphodiesterase. Bioequivalence of two cilostazol tablets, the $Pletaal^{TM}$ (Korea Otsuka Pharmaceutical Co.) and the LG $Cilostazol^{TM}$ (LG Chemical Co.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers ($20\sim29$ years old) were randomly divided into two groups and a randomized $2\times2$ cross-over study was employed. After oral administration of $Pletaal^{TM}$ or LG $Cilostazol^{TM}$ tablet (100 mg cilostazol), blood samples were taken at predetermined time intervals and the serum cilostazol concentrations were determined using an HPLC method with UV/VIS detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\;T_{max})$ were calculated and ANOVA was utilized for the statistical analysis. The results showed that the differences in AUCt, C_{max} and Tmax between two tablets based on the $Pletaal^{TM}$ tablet were $-5.39\%,\;2.32\%\;and\;4.26\%$, respectively. The powers (1-${\beta}$) for $AUC_t,\;C_{max}\;and\;T_{max}\;were\;83.81\%,\;96.02\%\;and\;91.04%$, respectively. Minimum detectable differences ($\Delta$) and $90\%$ confidence intervals were all less than $\pm20\%$. All these parameters met the criteria of KFDA for bioequivalence, indicating that LG $Cilostazol^{TM}$ tablet is bioequivalent to $Pletaal^{TM}$ tablet.

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Treatment outcome of conservative surgery plus postoperative radiotherapy for extremity soft tissue sarcoma

  • Lee, Ji-Eun;Park, Young-Je;Yang, Dae-Sik;Yoon, Won-Sup;Lee, Jung-Ae;Rim, Chai-Hong;Kim, Chul-Yong
    • Radiation Oncology Journal
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    • v.30 no.2
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    • pp.62-69
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    • 2012
  • Purpose: To evaluate the treatment outcome and prognostic factor of postoperative radiotherapy for extremity soft tissue sarcoma (STS). Materials and Methods: Forty three patients with extremity STS were treated with conservative surgery and postoperative radiotherapy from January 1981 to December 2010 at Korea University Medical Center. Median total 60 Gy (range, 50 to 74.4 Gy) of radiation was delivered and 7 patients were treated with chemotherapy. Results: The median follow-up period was 70 months (range, 5 to 302 months). Twelve patients (27.9%) sustained relapse of their disease. Local recurrence occurred in 3 patients (7.0%) and distant metastases developed in 10 patients (23.3%). The 5-year overall survival (OS) was 69.2% and disease free survival was 67.9%. The 5-year local relapse-free survival was 90.7% and distant relapse-free survival was 73.3%. On univariate analysis, no significant prognostic factors were associated with development of local recurrence. Histologic grade (p = 0.005) and stage (p = 0.02) influenced the development of distant metastases. Histologic grade was unique significant prognostic factor for the OS on univariate and multivariate analysis. Severe acute treatment-related complications, Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4, developed in 6 patients (14.0%) and severe late complications in 2 patients (4.7%). Conclusion: Conservative surgery with postoperative radiotherapy achieved a satisfactory rate of local control with acceptable complication rate in extremity STS. Most failures were distant metastases that correlate with tumor grade and stage. The majority of local recurrences developed within the field. Selective dose escalation of radiotherapy or development of effective systemic treatment might be considered.

A Study on Consumer Preference for Plastic Toilet Seats with Selective Automatic Supply of Recycled Water (재활용수의 선택적 자동공급이 가능한 플라스틱류 양변기 소비자 선호도에 관한 연구)

  • Choi, Tae-Wol;Baeg, Jong-Ho;Bae, Sang-Mok
    • Industry Promotion Research
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    • v.5 no.1
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    • pp.13-20
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    • 2020
  • This study is about consumer preference of plastic toilets that can provide automatic supply of recycled water. First, the preference for plastic toilet seat design by gender and age group was preferred for gender type C and G for the sex. As the result of the chi-square test, the significance probability is .044 and the significance is P <.0 5. I could confirm that. Age, teens, 40 s, and 50 s or older prefer type C, 20 s and 30 s, but B type is not statistically significant. Second, the differences among the groups of preference for appearance design criteria according to general characteristics were all stable (stable appearance) in gender, age, region, education, and salary, but the chi-square test showed that they were not statistically significant. There was no difference between them. This study has implications for improving competitiveness and productivity by reducing the main production cost by commercializing toilets made of plastic materials.

A CLINICAL STUDY OF THE EFFECTS ON THE HEALING PROCESS OF ADMINISTRATION OF THE ZEA MAYS L. AFTER PERIODONTAL SURGERY (치주수술후 Zea Mays L. 투여가 치유과정에 미치는 영향에 대한 임상적 연구)

  • Kwon, Young-Hyuk;Lee, Man-Sup;Yang, Seung-Han;Kim, Young;Park, Joon-Bong
    • Journal of Periodontal and Implant Science
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    • v.24 no.3
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    • pp.649-660
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    • 1994
  • The purpose of this study was to evaluate the effects of administration of Zea Mays L. on the healing process after periodontal surgery as adjuntives. Authors used 3 kinds of different clinical criteria, depth of periodontal pocket by using the Goldman Fox periodontal probe, degree, of tooth mobility by Periotest, and amount of occlusal force with electronic device. In this comparative clinical study, 30 patients who were divided into two group, 15 ZML administrated group and 15 placebo adminstrated group, were participated. All the examined teeth were isolated with gauze and air spray, and measured each clinical critera on the day of before surgery, 1, 2, 4, 8 weeks after surgery. The results were as follows. 1. The changes of the periodontal pocket depth, on the both of Zea Mays L. administrated group and placebo adminstrated group, revealed the decreasing tendency, and it was shown the time dependent tendency. But there was no statistically significant differences between the two group. 2. In the case of tooth mobility, both group showed the highest severe mobility on the 1 week after surgery. It was observed that experimental group had more effects on decreasing the mobility. But there was no statistically significant differences between the two group. 3. In the case of experimental group, the recovery trend of occlusal forces after periodontal surgery on the molar teeth revealed higher than the control group. But there was no statistically significant differences between the two group. In conclusion, Zea Mays L. may play a favorable role in the healing process after periodontal surgery. It was suggested that further study to evaluate the effects of selective administration on the patient who have systemic diseases should be needed.

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Bioequivalence of Hanmi Fexofenadine Hydrochloride Tablet 120 mg (한미염산펙소페나딘정 120 mg의 생물학적 동등성)

  • Ko In-Ja;Hai Nguyen Thien;Chi Sang-Cheol
    • Korean Journal of Clinical Pharmacy
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    • v.16 no.1
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    • pp.34-39
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    • 2006
  • Fexofenadine, one of selective histamine $H_1$ receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 120 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration(KFDA). The test product was Hanmi Fexofenadine Hydrochloride Tablet $120mg^{(R)}$ made by Hanmi Pharm. Co. and the reference product was Allegra Tablet $120mg^{(R)}$ made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a $2{\times}2$ cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t\;and\;C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t\;and\;C_{max}$ were log $0.844{\sim}log$ 1.149 and log $0.833{\sim}log$ 1.109, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet 120 mg is bioequivalent to Allegra Tablet 120 mg.

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Bioequivalence of Hanmi Fexofenadine Hydrochloride Tablet to Allegra Tablet(Fexofenadine Hydrochloride 180 mg) (알레그라정(염산펙소페나딘 180 mg)에 대한 한미염산펙소페나딘정의 생물학적 동등성)

  • Ko, In-Ja;Chi, Sang-Cheol
    • Journal of Pharmaceutical Investigation
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    • v.36 no.1
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    • pp.53-58
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    • 2006
  • Fexofenadine, one of selective histamine $H_1$ receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 180 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Hanmi Fexofenadine Hydrochloride $Tablet^{\circledR}$ made by Hanmi Pharm. Co. and the reference product was Allegra $Tablet^{\circledR}$ made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a $2\;{\time}\;2$ cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t$ and $C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t$ and $C_{max}$ were $log\;0.822{\sim}log \;1.142$ and $log\;0.848{\sim}log\;1.172$, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet is bioequivalent to Allegra Tablet.

A study on the temperature distribution characteristics in the tube modules of a heat recovery steam generator ith the change of heat transfer modeling (배열회수 보일러 전열관군에서 열전달 모델링에 따른 온도 분포 특성 연구)

  • Ha, Ji Soo
    • Journal of Energy Engineering
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    • v.24 no.2
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    • pp.103-109
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    • 2015
  • A heat recovery steam generator consists of inlet expansion duct and heat transfer tube bank modules. For the enhancement of heat transfer in the tube bank modules, the flow should be uniform before the 1st heat transfer tube bank module. The present study has been carried out to analyze the flow characteristics in the inlet expansion duct of a heat recovery steam generator by using numerical flow analysis. The aim of the present study is to establish the proper heat transfer mechanism in the heat transfer tube bank modules by the comparison of the heat transfer models, the case with the constant heat loss per unit volume and the case with heat loss by using inner and outer convective heat transfer coefficient of heat transfer tube. From the present research, it could be seen that the heat transfer mechanism with using inner and outer convective heat transfer coefficient derives more proper temperature distribution results and the acceptance criteria of the temperature distribution within ${\pm}10^{\circ}C$ before SCR is satisfied with using this heat transfer mechanism.

Diversity of Repetitive Sequences in Toxigenic Cyanobacteria Detected by Repetitive Oligonucleotides-Primed PCR (반복염기 프라이머 PCR에 의해 탐색된 독성 남조류에 분포한 반복염기의 다양성)

  • Koo, Jung-Mo;Yoo, Soon-Ae;Park, Sang-Ho;Choi, Chang-Won
    • Korean Journal of Ecology and Environment
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    • v.33 no.3 s.91
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    • pp.206-212
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    • 2000
  • Since some cyanobacterial isolates under selective culturing conditions are lacking of characteristic specialized cells or showing altered morphology, the morpho-taxonomic criteria are not accurate enough to discriminate between species. Instead of morphological parameters, a method based on the single or the combination of repetitive oligonucleotides in a single PCR, repetitive oligonucleotides-primed PCR (ROP-PCR), was applied to generate DNA profiles for members of the cyanobacterial genera Anabaena and Oscillatoria, both of which are responsible for causing poisonous blooms in various freshwater systems. ROP-PCR performed on 10 isolates of the cyanobacteria with ERIC and REP sequences from gram-negative bacteria, STRR1A and LTRR sequences derived from cyanobacterial genome, and eukaryotic repetitive sequences, led to the identification of distinct genotypes, and provided specific and repeatable DNA fingerprints for cyanobacterial isolates. Grouping analysis of cyanobacterial isolates showed a signifiant difference depending on the primer used in PCR.

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The Study on the Urinary Iodine Excretion of Koreans Living in Rural Areas

  • Lee, Jun-Ho;Min, Byung-Woon
    • Korean Journal of Clinical Laboratory Science
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    • v.43 no.3
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    • pp.105-112
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    • 2011
  • More accurate evaluation of iodine consumption of Koreans can be made by measuring the urinary iodine excretion of people living in representative areas. The data about average iodine excretions by region, sex and age were gathered in order to suggest as a factor the criteria on the progress or prognosis of thyroid disease patients. This study was conducted on 3,000 subjects (2,000 Younggwang-gun residents and 1,000 Muan-gun residents) between July 2004 and August 2005. The data sampling was done based on stratified random sampling and the data were analyzed according to age (the subjects were divided into age groups, five years each) and sex of the subjects. Of the 3,000 subjects, a total of 1,592 people (1,174 in Younggwang-gun and 418 in Muan-gun) participated in this study, which used ISE (iodine ion selective electrode) to measure the concentration of iodine in urine. The 1,592 subjects are composed of 732 males and 860 females. The average urinary iodine excretion was $3.10{\pm}1.75mg/L$ (0.31~15.2 mg/L). The average iodine excretion of males was $3.09{\pm}1.61mg/L$ (0.42~15.2 mg/L) while it was $3.11{\pm}1.86mg/L$ (0.31~12.5 mg/L) among females, which represents no significant difference between males and females. However, the values were significantly higher than those of Europeans and Americans. There were statistically significant differences among the regions. When the data were analyzed according to age, females in their 40s were found to have a little less urinary iodine excretion and males had less and less iodine excretion as they get older. These results are deemed to have a statistically significant difference. This study was conducted on a large number of people (N=1,592) for the first time in Korea. If the data collected through this study can be regarded as the average urinary iodine excretion of Koreans, it is possible to conclude that the average iodine consumptions of Koreans are a lot more than Europeans and Americans. Thus, the effect of much iodine consumption should be studied further.

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Bioequivalence of Lisihexal® tablet to Zestril® tablet(Lisinopril 10 mg) (제스트릴®정(리시노프릴, 10 mg)에 대한 리시헥살®정의 생물학적동등성)

  • Oh, Soo-Yeon;Aryal Dipendra Kumar;Cho, Jong-Tae;Kim, Hyung-Gun;Kim, Yoon-Gyoon
    • Journal of Pharmaceutical Investigation
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    • v.36 no.4
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    • pp.277-282
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    • 2006
  • Lisinopril is one of the angiotensin-converting enzyme inhibitors, which have been used for treatment of hypertension and heart failure. The aim of this study was to evaluate the bioequivalence of two lisinopril tablet, $Lisihexal^{\circledR}$ and $Zestril^{\circledR}$ as a test and reference, respectively. The study was came out on 28 healthy male Korean volunteers in $2{\times}2$ crossover design. An analytical method with LC-MS-MS was developed for the quantification of lisinopril and enalapril(IS) using SPE method. The condition was selective, sensitive and precise in human plasma, that was enough for the pharmacokinetic study of lisinopril. The pharmacokinetic parameters such as $AUC_t,\;AUC_{inf},\;C_{max},\;T_{max}\;and\;t_{1/2}$ were calculated and ANOVA test was used for the statistical analysis of the parameters using log transformed $AUC_t,\;AUC_{inf}\;and\;C_{max}$. $t_{1/2}$ of test and reference drugs were calculated $11.4{\pm}5.1\;and\;16.1{\pm}9.9\;hr$, respectively. The 90% confidence intervals of $AUC_t,\;AUC_{inf}\;and\;C_{max}$ were log 0.9245$\sim$log 1.0603, log 0.9270$\sim$log 1.0601 and log 0.9548$\sim$log 1.1009, within the acceptable range of log 0.8 to log 1.25 by KFDA bioequivalence criteria. Two medications of lisinopril were evaluated bioequivalent and thus may be prescribed interchangeably.