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단보 : 건일로딘 캡슐(에토돌락 200 mg)에 대한 에토딘 캡슐의 생물학적동등성
이명재 ( Myung Jae Lee ),강종민 ( Jong Min Kang ),최상준 ( Sang Jun Choi ),이진성 ( Jin Sung Lee ),탁성권 ( Sung Kwon Tak ),서지형 ( Ji Hyung Seo ),류재환 ( Jae Hwan Rew ),임성빈 ( Sung Vin Yim ),이경태 ( Kyung Tae Lee ) 한국약제학회 2008 Journal of Pharmaceutical Investigation Vol.38 No.6
사무직 여성 근로자의 경부 통증과 물리적 요인의 상관성 연구
남기봉,조융기,류재환,김성수,Nam, Ki-Bong,Jo, Yoong-Ki,Rew, Jae-Hwan,Kim, Sung-Su 척추신경추나의학회 2009 척추신경추나의학회지 Vol.4 No.1
Objectives : The purpose of this study was to investigate the relation between neck pain and physical factors in female office workers. Methods : Neck pain group of 31 female subjects complained of neck and arm discomfort. Normal group of 20 female subjects had no complaints or minimal discomfort. Cervical curvature and muscle tone were assessed by whole spine x-ray, meridian-electromyography(MEMG), craniovertebral angle. Neck pain was evaluated by Neck Disability Index(NDI) and Visual Analog Scale(VAS). Results : The NDI score and contraction power of upper trapezius by MEMG had a relationship significantly. However, there was no relationship between NDI and cervical curvature. Conclusions : The results suggest that neck pain is related to muscle tone rather than physical stress and cervical curvature.
레니텍<sup>®</sup> 정(말레인산 에날라프릴, 10 mg)에 대한 에나레이스 정의 생물학적 동등성
조성희,하용화,홍성제,서성훈,류재환,김동현,이경태,Cho, Sung-Hee,Ha, Yong-Hwa,Hong, Sung-Je,Seo, Seong-Hoon,Rew, Jae-Hwan,Kim, Dong-Hyun,Lee, Kyung-Tae 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.3
The purpose of the present study was to evaluate the bioequivalence of two enalapril maleate tablets, $Renitec^{TM}$ (MSD Korea Ltd.) and $Enalace^{TM}$ (Welfide Korea Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, $22.33{\pm}2.55$ year in age and $66.54{\pm}8.30$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 10 mg of enalapril maleate per tablet were orally administered, blood was taken at predetermined time intervals and concentrations of enalapril in plasma were determined using LC-MS-MS. Pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t,\;and\;C_{max}$ untransformed $T_{max}$. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log0.8 to log1.25$(e.g.,\;log1.02{\sim}log1.14\;and\;log1.03{\sim}log1.19\;for\;AUC_t\;and\;C_{max},\;respectively)$. The major parameters, $AUC_t,\;and\;C_{max}$, met the criteria of KDFA for bioequivalence indicating that $Enalace^{TM}$ tablet is bioequivalent to $Renitec^{TM}$ tablet.
하루날<sup>®</sup> 캡슐(염산 탐스로신, 0.2 mg)에 대한 유타날<sup>®</sup> 캡슐의 생물학적동등성
임호택,조성희,이헌우,박완수,김영관,류재환,이경태,Im, Ho-Taek,Cho, Sung-Hee,Lee, Heon-Woo,Park, Wan-Su,Kim, Young-Kwan,Rew, Jae-Hwan,Lee, Kyung-Tae 한국약제학회 2005 Journal of Pharmaceutical Investigation Vol.35 No.4
The purpose of the present study was to evaluate the bioequivalence of tamsulosin HCl capsule, $Harnal^{\circledR}$(Jeil Korea Ltd.) and $Yutanal^{\circledR}$(Kukje Korea Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, $23.29{\pm}2.14$ year in age and $72.08{\pm}7.83$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 0.2 mg of tamsulosin HCl were orally administered, blood was taken at predetermined time intervals and concentrations of tamsulosin in plasma were determined using LC-MS/MS. Pharmacokinetic parameters such as $AUC_t$, $T_{max}$ and $C_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log0.8 to log1.25 (e.g., $log0.93{\sim}log1.11$ and $log0.80{\sim}log0.94$ for $AUC_t$, and $C_{max}$, respectively). The major parameters, $AUC_t$, and $C_{max}$, met the criteria of KFDA for bioequivalence indicating that $Yutanal^{\circledR}$ capsule is bioequivalent to $Harnal^{\circledR}$ capsule.
란크릭 캅셀(플루옥세틴 20mg)에 대한 프로작 캅셀의 생물학적 동등성 시험
심상범,조요나,오한석,류재환,이경태,김남재,서성훈 경희대학교 동서의학연구소 2001 東西醫學硏究所 論文集 Vol.2000 No.-
Bioequivalence of two flouxetine capsule, ProzacR (Lilly kora Ltd.) and LanclicR (Samsung Pharm. IND. Co.), was evalated according to the guideline of KFDA. Twenty four healthy male volunteers (21-26 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 60mg of fluoxetine was orally administered, blood was taken at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 32, 48 and 72 hours after administration and just before administration. Plasma was analyzed for fluoxetine and internal standard (clomipramine) by a sensitive and validated HPLC assay. The pharmaco kinetic parameters (AUCt, Cmax and Tmax) wre calculated and ANOVA test was used for the statistical analysis of parameters. Differences in (AUCt, Cmax and Tmax between two capsules were -0.90, 3.46 and -14.08% respectively. All powers (1-β) for AUGt, Cmax and Tmax were more than 0.9. Detectable differences (Δ) and confidence interval were all less than ±20%. All the parameters above met the criteria of KFDA for bioequivalence and indicated that LanclicR capsules are bioequivalent to ProzacR capsules.
인체 혈장에서 염산시프로플록사신(시프로플록사신으로서 250㎎) 정량을 위한 HPLC 분석법의 유효성검토
하용화,조성희,천성국,서성훈,류재환,최영욱,이경태 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.4
A simple HPLC method with ultraviolet detection of ciprofloxacin in human plasma was developed and validated. After protein precipitation with trichloroacetic acid, chromatographic separation of ciprofloxacin in plasma was achieved at 50℃ with a C_18 column and methanol-phosphate mixture (pH 2.5), as mobile phase. Quantitative determination was performed by ultraviolet detection at 278 nm. The method was specific and validated with a limit of quantification of 100 ng/ml. The infra- and inter-day coefficients of variation were between 1.67% and 10.55% and accuracy between 92.01% and 106.09%. The method has been successfully applied in a bioavailability study of 250 ㎎ ciprofloxacin hydrochloride tablet.
레니텍^(�) 정(말레인산 에날라프릴, 10mg)에 대한 에나레이스 정의 생물학적 동등성
조성희,하용화,홍성제,서성훈,류재환,김동현,이경태 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.3
The purpose of present study was to evaluate the bioequivalence of two enalapril maleate tablets, Renitec^(™) (MSD Korea Ltd.) and Enalace ^(™) (Welfide Korea Ltd.), according to the guidelines of Korea Food Drug Administration (KFDA). Twenty-four normal male volunteers, 22.33±2.55 year in age and 66.54±8.30 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containint 10 ㎎ of enal-april maleate per tablet wre orally administered, blood was taken at predetermined time intervals and concentrations of enalapril in plasma were determined using LC-MS-MS. Pharmacokinetic parameters such as AUC_(t), C_(max) and T_(max) were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUC_(t) and C_(max) untransformed T_(max). There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transfored data were acceptance range of log0.8 to log1.25(e.g., log1.02∼log1.14 and log1.03∼log1.19 for AUC_(t) and C_(max), respectively). The major parameters, AUC_(t) and C_(max), met the criteria of KDFA for bioequivalence indicating that Enalace^(™) tablet is bioequivalent to Renitec^(™) tablet.
타리비드 정(오플록사신 100㎎)에 대한 파비드 정의 생물학적동등성
박완수,조성희,이헌우,임호택,홍성제,서성훈,류재환,이경태 한국약제학회 2005 Journal of Pharmaceutical Investigation Vol.35 No.1
The purpose of the present study was designed to evaluate the bioequivalence of two ofloxacin tablets, Tarivid (Jell Pharm. Co., Ltd.) and Favid (ILHWA Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, 23.67±3.12 year in age and 68.50±7.23 kg in body weight, were divided into two groups and a randomized 2x2 cross-over study was employed. After four tablets containing 100 mg of ofloxacin were orally administered, blood was taken at predetermined time intervals and concentrations of ofloxacin in plasma were deter mined using HPLC. Pharmacokinetic parameters such as AUC_(t) and T_(max) were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUC_(t), and C_(max) and untransformed T_(max). There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log 0.8 to log 1.25 (e.g., log 0.94-log 1.04 and log 0.90-log 1.07 for AUC_(t) and C_(max) respectively). The major parameters. AUC_(t) and C_(max) met the criteria of KDFA for bioequivalence indicating that Favid tablet is bioequivalent to Tarivid tablet.