• 제목/요약/키워드: selective criteria

검색결과 118건 처리시간 0.021초

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

  • 조혜영;임동구;신상철;문재동;이용복
    • 한국임상약학회지
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    • 제11권1호
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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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    • 제30권2호
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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.

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

  • 최태월;백종호;배상목
    • 산업진흥연구
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    • 제5권1호
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    • pp.13-20
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    • 2020
  • 본 연구는 재활용수의 선택적 자동공급이 가능한 플라스틱류 양변기 소비자 선호도에 관한 연구로서 연구분석 결과를 요약하면 다음과 같다. 첫째, 성별, 연령대별 플라스틱류 양변기 디자인 외형에 대한 선호도는 성별에서는 남녀 모드 C 타입을 선호하였고, 카이제곱 검정결과 자유도가 2일 때 유의확률은 .044로 유의성이 P<.05이므로 통계적으로 유의한 것으로 확인 할 수 있었다. 연령에서는 10대, 40대, 50대 이상은 C 타입, 20대, 30대는 B 타입을 선호하는 것으로 분석되었으나 통계적으로 유의하지 못한 것으로 분석되었다. 둘째, 일반적 특성에 따른 외형디자인 기준에 대한 선호도의 집단 간 차이는 성별, 연령, 지역, 학력, 연봉에서모두 안정성(안정적인 외관)을 선호하였으나, 카이제곱 검증 결과, 통계적으로 유의하지 못한 것으로 나타나 집단 간 차이는 없는 것으로 분석되었다. 본 연구는 플라스틱류 소재의 양변기를 제품화함으로써 주요 생산경비 절감 등 경쟁력 및 생산성 향상을 높이는데 본 연구의 시사점이 있다.

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

  • 권영혁;이만섭;양승한;김영;박준봉
    • Journal of Periodontal and Implant Science
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    • 제24권3호
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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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한미염산펙소페나딘정 120 mg의 생물학적 동등성 (Bioequivalence of Hanmi Fexofenadine Hydrochloride Tablet 120 mg)

  • 고인자;이엔티엔하이;지상철
    • 한국임상약학회지
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    • 제16권1호
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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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알레그라정(염산펙소페나딘 180 mg)에 대한 한미염산펙소페나딘정의 생물학적 동등성 (Bioequivalence of Hanmi Fexofenadine Hydrochloride Tablet to Allegra Tablet(Fexofenadine Hydrochloride 180 mg))

  • 고인자;지상철
    • Journal of Pharmaceutical Investigation
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    • 제36권1호
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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.

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

  • 하지수
    • 에너지공학
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    • 제24권2호
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    • pp.103-109
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    • 2015
  • 배열회수 보일러는 입구 확관 덕트와 전열관군으로 이루어져 있는데 전열관군에서 열전달 효율을 향상하기 위해서는 전열관군 전에서 배기가스 유동이 균일하게 되어야 한다. 본 연구에서는 전열관군 전의 배열회수 보일러 입구 덕트에서 유동 특성을 살펴보았고 전열관군의 열전달 메커니즘을 지금까지 다른 연구들에서 적용하였던 일정한 열전달 량으로 한 경우와 전열관군 배관의 내부와 외부의 대류열전달을 고려한 열전달 메커니즘을 적용한 경우의 해석에서 온도 분포를 비교하여 배열회수 보일러의 전열관군에서 실제 현상에 보다 적합한 열전달 메커니즘을 정립하는 것을 목적으로 하였다. 본 연구를 통하여 전열관군 배관의 내부와 외부의 대류열전달을 고려한 열전달 메커니즘을 적용한 해석이 일정한 열전달 량을 적용한 경우보다 온도 분포가 타당한 결과를 도출하였고 이렇게 적용한 경우는 배열회수 보일러 탈질설비 전단에서 온도 분포가 설계 기준 ${\pm}10^{\circ}C$에 만족함을 알 수 있었다.

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

  • 구정모;유순애;박상호;최창원
    • 생태와환경
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    • 제33권3호통권91호
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    • pp.206-212
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    • 2000
  • 남조류 분리균주들은 주어진 배양조건에 따라서 특징적인 세포모양이 결핍되거나 형태가 변형되기 쉽기 때문에, 형태학적으로 종을 정확하게 구분하기 어렵다. 형태학적 지표대신에 단일 혹은 조합된 반복염기를 프라이머로 이용한 repetitive oligonucleotides-primed PCR (ROP-PCR)을 수행하여 담수계 오염을 일으키는 독성 남조류 Anabaena와 Oscillatoria 속의 구성원들의 DNA 밴드양상을 구별하였다. 그람음성 세균에 빈번하게 분포한 것으로 알려진 ERIC및 REP 반복염기, 남조류의 게놈으로부터 파생된 STRRIA와 LTRR 반복염기, 그리고 진핵생물의 반복염기를 이용하여 수행한 ROP-PCR은 남조류 분리균주들의 특이적이고 반복적인 DNA 지문 및 뚜렷한 유전형을 동정하게 하였다. 분리균주의 그룹분석은 ROP-PCR에 이용된 프라이머에 따라서 유의성있는 차이를 나타내었다.

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

  • Lee, Jun-Ho;Min, Byung-Woon
    • 대한임상검사과학회지
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    • 제43권3호
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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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제스트릴®정(리시노프릴, 10 mg)에 대한 리시헥살®정의 생물학적동등성 (Bioequivalence of Lisihexal® tablet to Zestril® tablet(Lisinopril 10 mg))

  • 오수연;디펜드라 쿠마 아리얼;조종태;김형건;김윤균
    • Journal of Pharmaceutical Investigation
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    • 제36권4호
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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.