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서효범,조승일,윤영란,임동석 대한임상약리학회 2017 Translational and Clinical Pharmacology Vol.25 No.4
This study describes the development of an analytical method to determine radotinib levels in humanplasma using high performance liquid chromatography (HPLC) coupled with triple quadrupoletandem mass spectrometry (MS/MS) for pharmacokinetic application. Plasma samples weresequentially processed by liquid.liquid extraction using methyl tert-butyl ether, evaporation, andreconstitution. Analytes were separated and analyzed using HPLC-MS/MS in selected reactionmonitoring mode, monitoring the specific transitions of m/z 531 to 290 for radotinib and m/z 409to 238 for amlodipine (internal standard). The HPLC-MS/MS analytical method was validated withrespect to selectivity, linearity, sensitivity, accuracy, precision, recovery, and stability. Calibrationcurves were linear over a concentration range 5.3,000 ng/mL with correlation coefficients (r) >0.998. The lower limit of quantification for radotinib in plasma was 5 ng/mL. The accuracy and precisionof the analytical method were acceptable within 15% at all quality control levels. This methodwas suitable to determine radotinib levels in human plasma because of its simplicity, selectivity, precision,and accuracy.
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건강한 자원자에서 아스피린과 심바스타틴 병용투여 시, 심바스타틴이 아스피린의 약동학/약력학적 특성에 미치는 영향
구남이,김보형,정용주,임경수,서효범,임동석,신상구,장인진,유경상 대한임상약리학회 2011 Translational and Clinical Pharmacology Vol.19 No.2
Background: Both aspirin and simvastatin are prescribed as treatments or prevention of cardiovascular diseases. The aim of this study was to investigate the influence of simvastatin on pharmacokinetics and pharmacodynamics of aspirin after oral co-administration in healthy subjects. Methods: Subjects were orally administered aspirin 100 mg for 7 days followed by co-administration of aspirin 100 mg and simvastatin 40 mg for 7 days once daily. A series of blood samples were collected before and till 24hours after drug administration on Day 1 (single-dose of aspirin), Day 7 (multiple-dose of aspirin) and Day 14 (multiple-dose of aspirin and simvastatin). The effects of simvastatin on pharmacokinetics of acetylsalicylic acid and salicylic acid were assessed with the 90 % confidence intervals (CI_s) of thegeometric mean ratios (GMR_s) of Day 14 over Day 7 for maximum plasma concentration (C_max) and the area under the concentration-time curve (AUC_0-24). Pharmacodynamics was assessed with maximal changes of platelet aggregation from baseline. Results: Twenty-fourhealthy men aged 20 to 36 years were enrolled and 23 of them completed the study. GMRs (90 % CI_s) of C_max and AUC_0-24 for acetylsalicylic acid were 1.21 (1.04 - 1.42) and 1.28 (1.19 - 1.38), respectively. For salicylic acid, GMR_s of C_max and AUC_0-24 were 0.96 (0.91 - 1.00) and 1.00 (0.97 - 1.04), respectively. Maximal changes of platelet aggregation on Day 7 and Day 14 from baseline were not significantly different (p=0.41); 87.5 ± 8.8 % and 87.3 ± 9.2 %, respectively. Conclusion: Coadministration of simvastatin slightly increased the systemic exposure of acetylsalicylic acid with no changes of systemic exposure of salicylic acid or inhibition of platelet aggregation.
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