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국가임상시험사업단 주도 2012 임상시험 전문인력 인증시험 시범사업 시행결과
성숙진,임미선,옥선아,이주미,박성민,박정현,서정주,이혜원,신상구,박민수,윤영란,Seong, Sook Jin,Lim, Mi-Sun,Oak, Suna,Lee, Joomi,Park, Sung Min,Park, Jeonghyeon,Seo, Jeong Ju,Lee, Hae Won,Shin, Sang-Goo,Park, Min Soo,Yoon, Young-Ran 대한임상약리학회 2012 臨床藥理學會誌 Vol.20 No.2
Backgroung: In recent years, clinical trials have considerably increased and relevant education programs to clinical trials have been developed and implemented since 2008 in Korea. To enhance the quality as well as global competitiveness of clinical trial professionals (CTPs), a certification program of the human resource is needed. Accordingly, in Korea the first and the second certification examinations were implemented in February and October 2012, respectively. In this paper, introduction of the certification program of the human resource is described, and results of the cerification examinations and questionnaire survey are presented. Methods: Data including the examination results and questionaire survey was collected by cooperative officials in Korea National Enterprise for Clinical Trials. Applicants who were selected eligible for examination by the steering committee were asked to complete questionnaires provided with the test papers on the day of the certification examination. Results: In the first certification examination, a total of 221 eligible participants completed the examination. 99.5% of the participants responded the questionnaire survey. In the second examination, a total of 223 applicants participated. The examination consisted of 50 multiple-choice questions with cut-off score of 70 per cent score. 176 & 194 CTPs passed the first & second examinations respectively. Conclusion: This paper that described the results of the two cerification tests and questionnaire surveys might be helpful in establishment and activation of the certification program in the future. Quality improvement of CTPs and international competitiveness of clinical trial in Korea can be anticipated by the certification program.
건강한 남성 자원자에서 탐스로신의 공복 투여 시 항정상태의 약동학적 특성 연구
성숙진 ( Sook Jin Seong ),이혜원 ( Hae Won Lee ),이주미 ( Joomi Lee ),임미선 ( Mi Sun Lim ),김은희 ( Eun Hee Kim ),박성민 ( Sung Min Park ),권미리 ( Mi Ri Gwon ),윤영란 ( Young Ran Yoon ) 영남대학교 약품개발연구소 2014 영남대학교 약품개발연구소 연구업적집 Vol.24 No.0
Background: To evaluate the pharmacokinetic properties of daily oral doses of tamsulosin administered to fasted healthy Korean male volunteers for 5 days. Methods: In a randomized, open-label, multiple-dose, two-period, crossover study, all 44 subjects were randomly assigned in a 1:1 ratio to receive a newly developed generic capsule formulation (test) or a branded capsule formulation (reference) of tamsulosin 0.2 mg, followed by a 10-day washout period and administration of the other formulation. Plasma concentrations of tamsulosin were assessed after administration of five-day multiple doses, using HPLC-MS/MS. Clinical and laboratory adverse events (AE) were assessed. Results: The mean (SD) pharmacokinetic properties with the test and reference formulations were as follows: Css,max , 9.0 (2.9) and 8.4 (2.6) ng/mL, respectively; median (range) tmax, 4 (2-6) and 5 (2-7) hours; AUCτ, 93.7 (31.5) and 88.2 (29.3) ng × h/mL; and t½, 9.5 (2.6) and 10.0 (2.7) hours. The volume of distribution and clearance after oral administration of tamsulosin were 0.5 L/kg, and 0.04 L/h/kg, respectively. The accumulation ratios for 0.2 mg once-daily dosing regimen were 1.2. The 90% CIs of the geometric mean ratios for the log-transformed AUCτ (1.005-1.131) and Css,max (1.000-1.136) values were within the acceptable range for bioequivalence. No serious AE was reported during the study. Both formulations were well tolerated. Conclusion: The results demonstrate that the Css,max and AUCτ values in the fasted subjects were higher than those in the fed from other study, with a shorter tmax values.
이혜원 ( Hae Won Lee ),윤영란 ( Mi Sun Lim ),임미선 ( Sook Jin Seong ),성숙진 ( Joo Mi Lee ),이주미 ( Sung Min Park ),박성민 ( Keum Han Noh ),노금한 ( Sung Ho Park ),박성호 ( Eun Jung Kim ),김은정 ( Won Ku Kang ),강원구 ( Young Ra 영남대학교 약품개발연구소 2012 영남대학교 약품개발연구소 연구업적집 Vol.22 No.0
Modem biologics are biotechnology-derived therapeutics, ineluding recombinant therapeutie proteins like monoclonal antibodies, cytokines and tissue growth factors. Although the pharmacokinetics of therapeutic biologic should be evalu-ated based on the same general principles as small molecules, careful considerations should be given to bioanalyties and phannacokinetics when designing pharmaeokinetic studies of biologics during their drug development, due to their dif-feren physicochemical properties compared with small molecules. The aim of this study was to develop draft guid-ance on pharmacokinetic studies of therapeutic biologics in clinical studies. All the elements outlined in the current Food and Drug. Administration (FDA), European Medicinal Agency (EMEA), and International Conference on Hannom-isation (ICH) guidelines and regulations, and the related literatures previously published were searched and evaluated. In this drall guidance, the specitic problems to the pharmacokinetics of therapeutic biologics that need special consideration sideration during drug development process were addressed, and differences in pharmacokinetic characteristics between biologics and small molecules affecting the content of the development programme were presented.