Background: Since early 2000's Korean government introduced the INDA(Investigational New Drug Application) system and has operated clinical trial infrastructure conducting support program. In Korea the Clinical trials have shown rapid growth based on such active policy of Korean government. Additionally each institution does many efforts to provide high-quality clinical trials; establishment of the clinical trial center. Not only clinical trials are conducted by multi-disciplinary, but also need multistep to successful conduct. Catholic Medical Center (CMC) need to centralized system to provide 8 affiliated hospitals with high-quality clinical trials related service. For this, CMC CRCC (Catholic medical center clinical research coordinating center) was established at 2004. The administrative support division of CRCC has taken charge of main administrative affairs including consultation, research budget accounting, and computerized central trial management system(CTMS) operation. To provide better service weevaluated administrative work of CRCC by analyzing Q&A data since its opening. Method: Q&A records (from November 2004 to August 2007) of administrative support division of CRCC were analyzed. The records included requester information (affiliation, occupation), request and response method (verbal answer, letter or e-mail, others), required time for response, and classification of request. Since all variables were categorical, the results were only analyzed by descriptive methods. Result: Total 439 days' records were analyzed except the records omitted periods. Total Q&A cases were 22,748. Among these 63% were external and 36% were internal questions. As for affiliation and occupation of requester, the sponsor (55%), researchers (20%), nurses (11%), members of IRB (6%), and the others (7%). Over 85% request and response were used phone call as a method and over 10% used e-mail. The most frequent question was about research budget (30%), and then administrative affairs (26%), CTMS use (24%).

Background: Rifampicin is commonly used antimycobacterial drug and various formulations are available. The purpose of this study is to evaluate the bioequivalence of rifampicin in healthy Korean subjects. Methods: Under two way crossover Latin square design (2 sequences, 2 periods), twenty-one subjects were randomly allocated into two groups. After administration of rifampicin 600mg, blood sampling was done at prescheduled time points. Samples were analyzed using HPLC/UV method. Using WinNonlin V5.2, $C_{max},\;AUC_t$ and $T_{max}$ were calculated. ANOVA test was done for each pharmacokinetic parameter after log transformation. Results: There was no significant difference between 2 groups in demographic profile. Average AUCt of $Rifodex^{(R)}$ was $101.947{\pm}38.763\;ug{\cdot}hr/ml\;(Mean{\pm}SD)$ and that of $Rifampin^{(R)}$ was $104.480{\pm}38.122\;ug{\cdot}hr/ml\;(Mean{\pm}SD)$. Average $C_{max}$ was $16.399{\pm}5.367\;ug/ml\;(Mean{\pm}SD)$ for $Rifodex^{(R)}$, and $16.442{\pm}6.013\;ug/ml\;(Mean{\pm}SD)$ for $Rifampin^{(R)}$. Bioequivalence test for log($AUC_t$) and log($C_{max}$) showed that the 90% confidence interval for difference between 2 formulation is $-0.1128{\sim}0.0061,\;-0.0893{\sim}0.0779$. These values were within the bioequivalence range of -0.2231(=log 0.8)$\sim$0.2231(=log 1.25). Conclusion: Our study revealed that $Rifampin^{(R)}$ is bioequivalent to $Rifodex^{(R)}$ according to the guideline of Korea Food and Drug Administration(KFDA).

Backgound: Cephalexin is one of the first generation cephalosporins that has antibactericidal activity against gram-positive microorganisms. The purpose of the present study is to evaluate the bioequivalence of two cephalexin formulations(Kepacin capsule 500mg vs Falexin capsule 500mg), according to the guideline of the Korea Food and Drug Administration (KFDA) Methods: Twenty three healthy Korean male volunteers participated in this study. Under two-way, crossover, Latin-square design (1-week wash-out period), a pharmacokinetic study and bioequivalence test was performed. After oral administration of cephalexin 500mg, blood samples were taken at predetermined time points and the concentrations of cephalexin were quantified using HPLC/UV method. WinNonlin V5.0 was utilized for calculation of the pharmacokinetic parameters including $AUC_t,\;C_{max}$. Results: There were no significant differences in demographic and pharmacokinetic characteristics between $Kepacin^{TM}\;and\;Falexin^{TM}$. ANOVA test found no significant sequence effects for $AUC_t\;and\;C_{max}$. The 90% confidence intervals of the mean difference of log($AUC_t\;and\;C_{max}$) for $Kepacin^{TM}$ versus $Falexin^{TM}$ were log 0.94$\sim$log 1.03 and log 0.92$\sim$log 1.18, respectively. These values were within the bioequivalence range of log 0.8$\sim$log 1.25. Conclusion: Our study indicated that the pharmacokinetic profiles of cephalexin in Korean male subjects were not different from previous reports except low clearance. $Kepacin^{TM}$ was bioequivalent to $Falexin^{TM}$ with respect to the extent and rate of absorption.

연구배경: 타크로리무스는 이식환자들의 동종이식 거부반응을 예방하기 위해 사용된다. 타크로리무스는 치료 허용 범위가 좁고 개인 간, 개인 내 약동학적 차이가 높으므로 혈중 농도의 모니터링을 이용한 약물 투여 용량 조절이 필수적이다. 현재 타크로리무스의 흡수 기전에 관한 연구가 미흡하여 이번 연구를 통해 건강 피험자 중 타크로리무스의 최적의 흡수 모델을 정의하는 것을 목표로 하였다. 방 법: 31명의 건강한 성인들에게 각각 4 mg의 타크로리무스를 경구투여하였다. 채혈시점은 약물투여 전 및 투여 후 0.5, 1, 1.5, 2, 3, 6, 8, 10, 12, 24, 48, 60 ,72 시간이었으며 혈장 내 타크로리무스의 농도 분석은 HPLC-MS-MS를 이용하였다. 약동학적 분석을 위해 NONMEM을 사용하였고, 영차 흡수, 일차 흡수, 트랜짓 분획 흡수 모델에 2분획적 모델을 적용하여 비교하였다. 결과: 트랜짓 분획 흡수 모델이 타크로리무스의 약동학적 흡수 과정을 가장 잘 설명하는 것으로 나타났다. 여기서 적용된 3 가지의 흡수 모델 중 트랜짓 분획 흡수 모델에서 OFV와 RMSE가 가장 감소하였고, 각 개인 피험자들의 흡수기를 나타낸 그래프와 산점도 그림에서도 트랜짓 분획 흡수 모델이 일차 흡수 모델보다 더 우수했다. 결론: 우리는 최근에 고안되어진 트랜짓 분획 모델이 타크로리무스의 불규칙한 약동학적 흡수 과정을 나타내는 것에 유용한 모델임을 알 수 있었다. 타크로리무스의 흡수 과정이 제형에 관계 없이 불규칙적인 것으로 알려져 있으므로, 트랜짓 분획 모델이 흡수 지연 시간을 적용한 약동학적 흡수 과정의 특징을 생리학적으로 보다 잘 나타낼 것으로 기대한다.