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- 저자 : 김운집 (검색결과 2 건)
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노육환,고영주,정진아,김운집,진석준,황애경,박현정,배균섭,임형석 대한임상약리학회 2010 Translational and Clinical Pharmacology Vol.18 No.1
Aims: This study was aimed to characterize the population pharmacokinetics of Arimidex® (anastrozole) which has been administered to healthy Korean male volunteers. Methods: We have committed population pharmacokinetic analysis using NONMEM® VII with 408 plasma concentration data obtained from subjects who were administered with reference drug Arimidex® in a randomized, double-blind, two-way crossover bioequivalence trial conducted in Asan Medical Center. We estimated the parameters by first-order conditional estimation (FOCE) method, and then, observed the change of objective function values which had been calculated by using different compartment models, and explored the significant covariates. To evaluate the suitability and stability of final population model, we performed bootstrapping and visual/numerical predictive checks using Wings for NONMEM and Perl-speaks-NONMEM software. We simulated the plasma concentration corresponding to daily doses of anastrozole 1 mg through 10 days. Results: The plasma concentration data of Arimidex® is best fitted by first-order two-compartment linear model. The estimated absorption rate constant value is 0.23 h-1, and the final estimates for the volume of distribution of central and peripheral compartment is calculated as 5.12 L and 319 L,respectively. Conclusions: We successfully constructed the final population pharmacokinetic model of Arimidex® in this study, which could be useful for various purposes such as Monte-Carlo simulation for the plasma concentration-time profiles of Arimidex®.
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노육환,배균섭,조상헌,최상민,김종률,정진아,김운집,진석준,박현정,김정철,임형석,Noh, Yook-Hwan,Bae, Kyun-Seop,Cho, Sang-Heon,Choe, Sangmin,Ghim, Jong-Lyul,Jung, Jin Ah,Kim, Un-Jib,Jin, Seok-Joon,Park, Hyun-Jung,Kim, Jung-Chul,Lim, Hyeon Korean Society for Clinical Pharmacology and Thera 2012 臨床藥理學會誌 Vol.20 No.2
배경: 레트로졸은 유방암 치료에 사용되는 경구용 비스테로이드성 aromatase 억제제이다. 방법: 이 연구는 건강한 성인 남성을 대상으로 무작위 배정, 단회 투여, 공개설계로서 두 치료군, 두 순서, 두 시기의 교차 시험법으로 진행되었다. 각 순서군에 13명씩 무작위 배정되어, 한군은 1기에 페마라$^{(R)}$정(대조약)을, 2기에 유한 레트로졸정(시험약)을, 다른 한군은 반대 순서로 두 시기 사이에 약 5주의 휴약기를 가지고 각각 2.5 mg정 1정씩 투여 받았다. 약동학 분석을 위한 혈액 검체는 공복 상태에서 투약 후 312 시간까지 얻어졌다. 레트로졸의 혈장 내 농도는 liquid chromatography-tandem mass spectrometry를 이용하여 측정하였다. 안전성 평가는 활력징후, 문진 및 신체검사, 심전도, 진단검사실 검사와 이상반응 모니터링을 통하여 이루어졌다. 결과: 총 26명의 피험자가 연구를 완료하였고, 약동학 분석에 26명의 자료가 모두 사용되었다. $C_{max}$와 $AUC_{last}$ 파라미터에 대한 시험약과 대조약의 기하평균비는 각각 0.92 (90 % 신뢰구간: 0.85 - 0.99)와 1.01 (90 % 신뢰구간: 0.97 - 1.04)였다. 보고된 중대한 이상반응은 없었으며, 임상적으로 유의한 변화도 관찰되지 않았다. 결론: 건강한 자원자에서 페마라$^{(R)}$정과 유한 레트로졸정의 약동학 특성과 안전성은 유사하였다. Background: Letrozole is an oral non-steroidal inhibitor of the aromatase enzyme, which has proven to be a useful drug against breast cancer. Methods: This single-dose, randomized $2{\times}2$ crossover study was conducted in healthy male volunteers. Participants of each sequence group (each 13 volunteers for sequence group) received, in randomized sequence, a single oral 2.5-mg dose of generic letrozole (test) or branded letrozole (reference). Each treatment period was separated by a 5-week washout period. Blood samples were collected for up to 312 hours after drug administration, and drug concentrations were determined using validated LC/MS-MS. Pharmacokinetic properties were obtained using noncompartmental analysis. Drug tolerability was assessed throughout the study, using measurements of vital signs, physical examination, clinical chemistry testing, EKG, and interviews. Results: A total of 26 subjects completed the study. The geometric mean ratios (90% CI) of $C_{max}$ and $AUC_{last}$ were 0.92 (0.85 - 0.99) and 1.01 (0.97 - 1.04), respectively. No serious AEs were reported, and there were no clinically significant differences between test and reference groups. Conclusion: The findings from this study suggest bioequivalence between two formulations of letrozole in healthy male volunteers. The safety profile of two formulations had similar characteristics.
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