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연구논문 : 한국 동물대체시험법검증센터의 설립 및 국제협력
손수정 ( Soo Jung Sohn ),차혜진 ( Hye Jin Cha ),이용경 ( Yong Kyung Lee ),염영나 ( Young Na Yum ),한순영 ( Soon Young Han ) 한국동물실험대체법학회 2010 동물실험대체법학회지 Vol.4 No.2
Korean Center for the Validation of Alternative Methods (KoCVAM) was founded in 2009 as part of the Division of Toxicological Screening and Testing, Department of Toxicology Evaluation and Research at the National Institute of Food and Drug Safety Evaluation, affiliated with the Korea Food and Drug Administration. According to the Article five of the Korea Laboratory Animal Act, establishment of policies and their execution on the development and approval of alternative test methods are specified as duty of the commissioner of KFDA. KoCVAM was founded based on this law. The mission of KoCVAM are 1) promoting the 3Rs in regulatory science for the safety assessment, 2) evaluating the usefulness and limitations of alternative test methods, and 3) promoting cooperation both nationally and internationally to achieve international harmonization. In this paper we introduce KoCVAM`s organization and describe KoCVAM`s international activities.
손수정 ( Soo Jung Sohn ),차혜진 ( Hye Jin Cha ),이용경 ( Yong Kyung Lee ),염영나 ( Young Na Yum ),한순영 ( Soon Young Han ) 한국동물실험대체법학회 2010 동물실험대체법학회지 Vol.4 No.2
Korean Center for the Validation of Alternative Methods (KoCVAM) was founded in 2009 as part of the Division of Toxicological Screening and Testing, Department of Toxicology Evaluation and Research at the National Institute of Food and Drug Safety Evaluation, affiliated with the Korea Food and Drug Administration. According to the Article five of the Korea Laboratory Animal Act, establishment of policies and their execution on the development and approval of alternative test methods are specified as duty of the commissioner of KFDA. KoCVAM was founded based on this law. The mission of KoCVAM are 1) promoting the 3Rs in regulatory science for the safety assessment, 2) evaluating the usefulness and limitations of alternative test methods, and 3) promoting cooperation both nationally and internationally to achieve international harmonization. In this paper we introduce KoCVAM`s organization and describe KoCVAM`s international activities.
N-Methyl-N-Nitrosourea 유도 자매염색분체교환생성과 DNA메칠화에 대한 Galangin의 억제효과
손수정(Soo Jung Sohn),김정한(Jung Han Kim),김영진(Young Jin Kim),허인회(In Hoe Huh),허문영(Moon Young Heo) 대한약학회 1995 약학회지 Vol.39 No.1
In order to evaluate the suppressive effects of galangin on the DNA damage induced by N-methyl-N-nitrosourea(MNU), in vitro sister chromatid exchange(SCE) test using Chinese Hamster ovary(CHO) cells was performed. Also the determinations of [3H] MNU-induced total DNA binding and methylated DNA were performed to find out the mechanism of action by galangin. MNU-induced SCEs were significantly decreased by simultaneous and pretreatment of galangin when S-9 mix was added only. In post-treatment, however, the MNU-induced SCEs were not decreased whether S-9 mix was added or not. [3H] MNU-induced total DNA binding was significantly inhibited by the treatment of galangin in calf thymus DNA and CHO cells. HPLC analysis of DNA hydrolysates shows that galangin caused a dose-dependant decrease in calf thymus DNA, but not significant decrease in CHO cells. These results suggest that the inhibition of galangin on the MNU-induced SCEs is due to the decrease of DNA binding and methylation with MNU. Therefore, galangin may be useful as a chemopreventive agent of alkylating agents.
손수정(Soo Jung Sohn),강현구(Hyun Gu Kang),이선우(Sun Woo Yi),서수경(Soo Kyung Suh),박인숙(In Sook Park),안미령(Mee Ryung Ahn),최홍석(Hong Seok Choi),조재민(Jae Min Cho),손동환(Dong Hwan Sohn),유태무(Tae Moo Yoo),양지선(Ji Sun Yang) 한국환경성돌연변이발암원학회 2001 한국환경성돌연변이·발암원학회지 Vol.21 No.2
4-tert-octylphenol (OP) is a surfactant additive widely used in the manufacture of a variety of detergents and plastic products. Also, OP is known to have estrogenic activity by interacting with development and functions of endocrine system. This study was carried out to obtain toxicokinetic parameters of OP in male<br/> Sprague-Dawley rats. Male rats were administered OP, by either single oral (gavage) applications of 50, 100 or 200 mg/kg body weight. or a single intravenous injections of 1, 5 or 10 mg/kg body weight. Blood samples taken at several time intervals after administration were obtained from the femoral artery. Analysis of blood samples for OP was performed by gas chromatography mass spectrometry (GC/MS). The detection limit of OP was 1.9 ng/ml at SIM (selected ion monitoring) mode of GC/MS. Calibration curve for analysis of the concentrations of OP in plasma was (OP/butylphenol peak area ratio) = 0.0294 × (plasma conc.) + 0.028 (r²= 0.9991). The OP plasma concentration was 3921 ng/ml immediately after single intravenous application, decreased rapidly within 45 min, and was detectable at low concentration up to 6 hr after application. When administered orally in rats (50, 100 and 200 mg/kg), OP was detected in the blood early after gavage administration, indicating the rapid initial uptake from gastrointestinal tract, with Tmax obtained from 0.67~0.83 hr. Using the AUC (area under the curve) of plasma concentration vs. time, low oral bioavailabilities of 1.2, 5.0 and 5.3% were calculated for the 50, 100 and 200 mg/kg groups, respectively.
시험관내 용출 및 장관막 투과도와 생체이용률과의 상관성
서수경(Soo Kyung Suh),손수정(Soo Jung Sohn),박인숙(In Sook Park),최기환(Ki Hwan Choi),김순선(Soon Sun Kim),유태무(Tae Moo Yoo),조혜영(Hea Young Cho),이용복(Yong Bok Lee),김동섭(Dong Sup Kim),양지선(Ji Sun Yang) 대한약학회 2000 약학회지 Vol.44 No.5
A biopharmaceutics drug classification system for correlation between in vitro dissolution and in vivo bioavailability is proposed based on recognizing that drug dissolution and gastrointestinal permeability are the fundamental parameters controlling the rate and extent of drug absorption. The objective of this study was to assess whether in vitro dissolution profiles of immediate-release beta-blocker tablets can be correlated with intestinal membrane permeability and/or in vivo bioavailability. In vitro dissolution of the beta-blocker tablets was examined using KP VII Apparatus II methods at various pH. Intestinal membrane permeability was determined in vitro using the diffusion chamber method. Bioavailablity parameters were cited from literatures. The dissolution profiles did not accurately represent the in vivo bioavailablity. However, there were good correlations between intestinal membrane permeability and log P (n-octano/buffer). The correlations obtained in this study indicated that in vitro diffusion chamber method could be used to predict intestinal absorption in vivo.
클라리스로마이신의 건강한 한국 성인에 대한 집단 약물동태
김호순(Ho Soon Kim),손수정(Soo Jung Sohn),권광일(Kwang Il Kwon) 大韓藥學會 2002 약학회지 Vol.46 No.1
The purpose of this study was to estimate the population pharmacokinetics of clarithromycin in healthy adult Korean and to investigate the factors if1uencing the pharmacokinetics of clarithromycin. The population pharmacokinetic parameters of clarithromycin were calculated with the data from healthy adult Koreans. A total of 798 plasma concentrations obtained from 78 subjects after administration of a single oral dose of 250 mg or 500 mg were used for the modeling. The concentration-time data were fitted to a one-compartment open model assuming a first-order absorption and elimination with no lag time. The correlations between various factors [such as sex, age, height, welght, serum creatinine (Scr) and dose ] and pharmacokinetic parameters were estimated with stepwise linear regression analyses. The selected covariates were incorporated in the population model of NONMEM, and the importance of each covariate was investigated by means of backwards elimination. The apparent clearance (CL/F) was significantly correlated to Scr and sex, and the apparent volume of distribution (Vd/F) was significantly correlated to Scr and height in a nonlinear relationship. The population values of Ka was 1.8 hr-1, CL/F was 37.71 L/hr Vd/F was 200 L and t1/2 was 3.68 hrs for a male Korean with 170 cm height and 1.0 mg/dL Scr.