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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.
임호택(Ho-Tack Lim),유천열(Chun-Yeol You) 한국자기학회 2005 韓國磁氣學會誌 Vol.15 No.6
Effect of a ferromagnetic layer thickness on a narrow domain wall width is investigated. It is found that the narrow domain wall is formed in ferromagnetic/nonmagnetic/ferromagnetic multilayer structure with a local interlayer exchange coupling, and that the width of the narrow domain wall is affected by the ferromagnetic layer thickness. We performed micromagnetics simulations for the Fe₁/Cr/Fe₂ system with the local interlayer exchange coupling, with fixed thickness (20-㎚) of Fe₂ layer and various Fe₁ layer thickness (1, 2, 4, and 6 ㎚). Consequently, we confirmed that the thinner the Fe₁ layer thickness, the thinner the width of the domain wall is formed, because of the surface energy nature of the interlayer exchange coupling.
하루날 캡슐(염산 탐스로신, 0.2mg)에 대한 유타날 캡슐의 생물학적동등성
이경태,임호택,조성희,이헌우,박완수,김영관,류재환 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??(Jeil Korea Ltd.) and Yutanal??(Kukje Korea Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, 23.29±2.14 year in age and 72.08±7.83 kg in body weight, were divided into two groups and a randomized 2´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 AUCt, Tmax and Cmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt, Cmax and untransformed Tmax. 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~log1.11 and log0.80~log0.94 for AUCt and Cmax, respectively). The major parameters, AUCt and Cmax, met the criteria of KFDA for bioequivalence indicating that Yutanal?? capsule is bioequivalent to Harnal?? capsule.
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.