• 한국임상약학회지
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• 제15권1호
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• pp.21-26
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• 2005

A bioequivalence study of CKD $Cefaclor^{(R)}$ capsule (Chong Kun Dang Pharm Co., Ltd) to $Ceclor^{(R)}$ capsule (Lilly Korea Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the cefaclor dose of 250 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. An improved high-performance liquid chromatorgraphy (HPLC) analytical method with UV detection was used to determine plasma cefaclor concentration in human volunteers for 8 hr after oral drug administration. The area under the plasma concentration-time curve from time zero to 8 hr ($AUC_{0-8hr}$) was calculated by the linear trapezoidal rule. the $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_{0-8hr}\;and\;C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The $90{\%}$ confidence intervals of the $AUC_{0-8hr}$ ratio and the $C_{max}$ ratio for CKD $Cefaclor^{(R)}$ and $Ceclor^{(R)}$ were $0.9400{\leq}{\delta}{\leq}1.0345$ and $0.8858{\leq}{\delta}{\leq}1.1021$, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the of CKD $cefaclor^{(R)}$ capsule was bioequivalent to $Cefaclor^{(R)}$ capsule with respect to its bioavailability.

• Journal of Pharmaceutical Investigation
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• 제35권2호
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• pp.117-122
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• 2005

After establishing improved HPLC analytical method of cefaclor in human plasma samples, a bioavailability study of cefaclor capsules was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). The standard calibration curve using an HPLC with UV detector was constructed in a range of $0.0324{\sim}16\;{\mu}g/ml$. The 6% perchloric acid instead of 6% trichloroacetic acid was used to precipitate plasma protein. The HPLC chromatograms were precisely and accurately resolved when spiked with human plasma spiked with cefaclor and cephalexin (internal standard). Twenty healthy male Korean volunteers received two commercial cefaclor capsules, $Neocef^{\circledR}$ capsule (Jinyang Pharm. Co., Ltd) or $Ceclor^{\circledR}$ capsule (Lilly Korea. Co., Ltd.) at the 250 mg cefaclor in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of cefaclor were monitored for 8 hours after oral drug administration. $AUC_t$ the area under the plasma concentration-time curve from time zero to 8 hr (13 points), was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Neocef^{\circledR}/Ceclor^{\circledR}$ were $0.9049{\leq}{\delta}{\leq}1.226$, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Neocef^{\circledR}/Ceclor^{\circledR}$ with respect to the extent of absorption.

• Journal of Pharmaceutical Investigation
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• 제41권5호
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• pp.317-322
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• 2011

Sertraline HCl, (1S-cis)-4-(3, 4-dichloro-phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-l-naphthalenamine hydrochloride, is a potent and selective serotonin reuptake inhibitor which is used in the treatment of depression and obsessivecompulsive disorders. The purpose of the present study was to evaluate the bioequivalence of two sertraline HCl tablets, Traline tablet (Myungin Pharm. Co. Ltd.) and Zoloft$^{(R)}$ tablet (Pfizer Inc.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of sertraline from the two sertraline HCl formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $23.50{\pm}1.74$ years in age and $64.09{\pm}7.10\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 50 mg as sertraline HCl was orally administered, blood samples were taken at predetermined time intervals and the concentrations of sertraline in serum were determined using an online columnswitching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Zoloft$^{(R)}$ tablet, were 0.04, 3.26 and -1.29% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Traline tablet was bioequivalent to Zoloft$^{(R)}$ tablet.

• Journal of Pharmaceutical Investigation
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• 제41권2호
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• pp.117-123
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• 2011

Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin$^{(R)}$ tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $22.83{\pm}1.862$ years in age and $69.92{\pm}9.14$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC^t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin$^{(R)}$ tablet, were 2.03, 2.99 and -9.49% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin$^{(R)}$ tablet.

• Journal of Pharmaceutical Investigation
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• 제34권3호
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• pp.209-214
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• 2004

A bioequivalence study of $Roxithrin^{TM}$ tablet (Kukje Pharma. Ind. Co., Ltd.) to $Rulid^{TM}$ tablet (Han Dok Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the roxithromycin dose of 300 mg in a $2{\times}2$ crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography for over a period of 36 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 36 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Roxithrin^{TM}/Rulid^{TM}$ were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of $Roxithrin^{TM}$ and $Rulid^{TM}$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• 제38권6호
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• pp.421-427
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• 2008

The purpose of the present study was to evaluate the bioequivalence of two etodolac capsules, Kuhnillodin capsule (Kuhnil. Co., Ltd., Seoul, Korea) as reference drug and Etodin capsule (Myungmun Pharm. Co., Ltd., Seoul, Korea) as test drug, according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-three healthy male Korean volunteers received one capsule at the dose of 200 mg etodolac in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of etodolac were monitored by a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) for over a period of 24 hr after the administration. $AUC_{0-24\;hr}$ was calculated by the linear trapezoidal rule method. $C_{max}$ and $T_{max}$ were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) was carried out using logarithmically transformed $AUC_{0-24\;hr}$ and $C_{max}$. The 90% confidence intervals of the $AUC_{0-24\;hr}$ ratio and the $C_{max}$ ratio for Etodin/Kuhnillodin were $\log\;0.97{\sim}\log\;1.08$ and $\log\;0.89{\sim}\log\;1.19$, respectively. These values were within the acceptable bioequivalence intervals of $\log\;0.80{\sim}\log\;1.25$. Thus, our study demonstrated that Etodin was bioeqiovalent to Kuhnillodin preparation when the rate and extent of absorption between two preparations were compared.

• 한국의류학회지
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• 제32권6호
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• pp.859-870
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• 2008

본 연구의 목적은 21세기 패션컬렉션에 나타난 모즈 룩에 대한 다양한 미학적 고찰을 통해 사회문화적 배경과 시대정신에 따라 한 시대의 미의식이 패션에 반영되는 특성을 분석하여 패션의 문화적 역할을 재인식하고자 하는 것이다. 연구방법은 모즈와 모즈 룩에 대한 문헌고찰과 2001년부터 2006년까지의 패션잡지에 나타난 모즈 룩의 사진 168건의 자료를 통한 실증적 분석을 하였다. 분석결과, 21세기 패션에서의 모즈 룩은 미니멀 스타일, 스포츠 캐주얼 스타일, 빈티지 스타일, 댄디 & 앤드로지너스 스타일로 유형화할 수 있었다. 이처럼 모즈 룩은 젊음, 발랄함, 새로움 등의 감성과 절충될 뿐만 아니라 스포츠 룩 그리고 스트리트 패션에까지 나타남으로써 대중의 기호에 맞는 디자인 개발 및 새로운 미래 패션영감에 계속 반영 될 것이다.

• 한국융합학회논문지
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• 제12권10호
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• pp.137-144
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• 2021

이 연구는 치과 종사자들의 치과 건강보험 교육경험 및 교육요구도와 산정기준에 대한 지식수준에 미치는 요인을 분석하는 것을 목적으로 한다. 대구·경북 지역의 치과 종사자들을 연구대상으로 하였으며, 구글 설문지를 활용한 온라인 조사를 실시하였다. 연구대상자의 일반적 특성, 교육 경험, 교육 경험 및 교육요구도에 따른 지식수준을 알아보기 위하여 빈도분석과 교차분석 및 ANOVA분석을 사용하였다. 분석 결과, 치과 건강보험에 대한 지식수준 조사에서 청구 프로그램에서 자동으로 처리를 해주거나 오류창으로 알려주는 경우의 산정기준에 대한 오답률이 높았다. 근무경력이 많고 치과에서 보험청구를 하고 있거나 최근 6개월 동안 치과보험 교육 경험이 있는 대상자들에서 산정기준에 대한 지식수준이 높았다. 결론적으로, 정기적인 치과 건강보험 교육을 통해 변경되는 산정기준을 숙지하도록 해야만 정확하고 올바른 보험청구가 가능하다고 보여진다. 이 연구는 치과 종사자들의 전문적인 치과 보험청구를 위한 교육체계 마련에 기초자료를 제공할 것으로 기대한다.

• 대한통합의학회지
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• 제9권3호
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• pp.165-173
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• 2021

Purpose : Myofascial decompression is frequently mentioned as a method applied to cupping. The purpose of this study is to evaluate and compare active range of motion (AROM), muscle strength, and functional movement by applying myofascial decompression to the hamstrings. Methods : This study evaluated AROM, muscle strength, and functional movement by applying active movement myofascial decompression and static myofascial decompression to the dominant leg, respectively, in a crossover design conducted with normal adults (n=21) in their average 20s enrolled at G University in G city, Gyeongsangbuk-do. Active movement myofascial decompression was implemented for five minutes at a rate of 100 bpm to make the beats in flexion and extension respectively. Static myofascial decompression was only performed for five minutes while at rest. All of these interventions were performed at a cupping depth of two mm. After a one-week washout period, static was applied again to compare the same dependent variables. Results : Regarding AROM and muscle strength, both groups showed significant differences in the before and after results (p<.05). However, in the Functional Reach Aspect and Single Leg Hop test, the active movement myofascial decompression group showed better results. There was no statistical difference between the Active movement myofascial decompression group and Static myofascial decompression group in any dependent variable (p<.05). Conclusion : As a result of this experiment, both active movement myofascial decompression and static myofascial decompression had a positive effect on dependent variable. Therefore this study is meaningful in that it is easier and simpler to see the effect on flexibility, muscle strength, and functional movement just by implementing movement myofascial decompression.

• 한국측량학회지
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• 제36권6호
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• pp.573-580
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• 2018

최근 대피시설의 위치 적절성, 수용 능력 등을 분석하기 위한 연구가 다양하게 진행되고 있으나, 신규 대피시설의 위치를 선정하는 방법에 관한 연구는 상대적으로 부족하다. 만일의 사태에 대비하기 위해서 대피시설을 지정하는 것이므로, 효율적으로 대피시설의 위치를 선정하는 방법 또한 필요하다. 따라서 본 연구에서는 대피시설의 입지 적절성 분석에 활용되어온 네트워크 분석과 대표적인 휴리스틱 알고리즘인 유전자 알고리즘을 활용하여 대피시설의 위치를 선정하는 방법을 제시하였다. 먼저, 기존의 민방위 대피시설 자료를 토대로 네트워크 분석을 시행하여 연구지역의 대피 취약지를 살펴본 결과, 지역별로 편차가 큰 것을 확인할 수 있었다. 이에 연구지역의 대피 취약지를 최소화하는 것을 목적함수로 유전자 알고리즘을 설계하여 신규 대피시설의 위치를 결정하였다. 대피시설 후보지의 위치로 구성된 초기해를 무작위로 생성하였고, 선택, 교차, 변이의 과정을 통해 목적함수를 최대로 만족하는 해를 탐색하였다. 실험결과, 연구지역 내 대피 취약지역의 비율이 높은 곳이 우선적으로 선정되었으며, 제안 기법의 효용성이 확인되었다. 본 연구의 결과는 향후 새로운 대피시설의 위치를 지정하고 효율적인 대피 계획을 수립하는 데에 기여할 수 있을 것으로 기대된다.