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아젭틴 정(염산아젤라스틴 1mg)에 대한 아젤라 정의 생물학적 동등성
이성관,조혜영,오인준,이용복,문재동,윤지훈,서유리 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.1
Azelastine, a phthalazinone derivative, is an antiallergic agent which demonstrates histamine H₁-receptor antagonist activity and also inhibits histamine release from mast cells following antigen and non-antigen stimuli. Thus, azelastine may be useful in the management of both asthma and allergic disorders. The purpose of the present study was to evaluate the bioequivalence of two azelastine hydrochloride tablets, Azeptin^(TM) (Bu Kwang Pharmaceutical Co., Ltd.) and Azela^(TM) (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 22.44±2.01 years in age and 61.99±6.18 ㎏ in body weight, were divided into two groups and a randomized 2 × 2 cross-over study was employed. After two tablets containing 1 ㎎ of azelastine hydrochloride per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of azelastine in serum were determined using HPLC with fluorescence detector. 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. The results showed that the differences in AUC_t, C_(max) and T_(max) between two tablets were -6.45%, -2.60% and -7.14%, respectively, when calculated against the Azeptin^(TM) tablet. The powers (1-β) for AUC_t and C_(max) were 96.65% and 88.47%, respectively. Minimum detectable differences (△) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 14.40% and 17.65% for AUC_t and C_(max), respectively). The 90% confidence intervals were within ±20% (e.g., -14.87∼1.97 and -12.92∼7.72 for AUC_t and C_(max), respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Azela^(TM) tablet is bioequivalent to Azeptin^(TM) tablet.
Socio-Economic Impacts of an Unscheduled Event: A Case in Korea
이성관,강승림,김창호 한국도로학회 2009 한국도로학회논문집 Vol.11 No.1
Total number of recorded earthquakes in Korea is more than 2,000 of which 48 were catastrophic. The impacts from infrastructure damage due to an rthquake to production facilities and lifelines may spread across boundaries of several regions via import-export relationships and can bring serious economic impact to other regions. The economic impacts from unscheduled events stem not only from the damage and direct losses, but also from the indirect losses during the recovery and reconstruction periods. To recover and reconstruct the facilities and lifelines damaged by unexpected events through investment or government financial aid, both the direct and the indirect economic impacts from an event, need to be measured in regional and interregional contexts. Direct economic impact is the direct change of production and demand due to the disruption of production facilities and lifelines from an unexpected event, and indirect economic impact is the change in other sectors due to inter industry relationships. The purpose of the paper is to analyze various economic impacts of an earthquake, especially impacts on transportation networks in Korea. We collected spatial and economic data from Korea, and analyzed and estimated final demand loss and commodity flows from the unscheduled event. Total number of recorded earthquakes in Korea is more than 2,000 of which 48 were catastrophic. The impacts from infrastructure damage due to an rthquake to production facilities and lifelines may spread across boundaries of several regions via import-export relationships and can bring serious economic impact to other regions. The economic impacts from unscheduled events stem not only from the damage and direct losses, but also from the indirect losses during the recovery and reconstruction periods. To recover and reconstruct the facilities and lifelines damaged by unexpected events through investment or government financial aid, both the direct and the indirect economic impacts from an event, need to be measured in regional and interregional contexts. Direct economic impact is the direct change of production and demand due to the disruption of production facilities and lifelines from an unexpected event, and indirect economic impact is the change in other sectors due to inter industry relationships. The purpose of the paper is to analyze various economic impacts of an earthquake, especially impacts on transportation networks in Korea. We collected spatial and economic data from Korea, and analyzed and estimated final demand loss and commodity flows from the unscheduled event.