As clinical trial researchers and companies continue to partner, merge, outsource, and make submissions for marketing approvals, the needs for streamlined data exchange increases. One study estimates that the industry spends more than $156 million annually contract research organizations (CRO) to sponsors and from electronic data capture(EDC) providers or clinical laboratories to sponsors or CRO. Without the use of standards, the activities associated with clinical development require duplicating efforts and a lot of rework, which translates into more time and higher costs. It is in everyone's best interest to improve patient safety and reduce costs by bringing new treatments to market as quickly as possible, so the value of standardization is readily apparent. In 1997, The Clinical Data Interchange Standards Consortium (CDISC) established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. CDISC has developed six standards. We specific describes CDISC Submission Tabulation Data Model (SDTM) in clinical trial. Finally, our own regulation should be developed for streamlined data interchange as soon as possible.

Background: Lafutidine($Stogar^{(R)}$) is a novel histamine $H_2$ receptor antagonist with gastroprotective activity. It exhibited potent and long-lasting $H_2$ receptor antagonism and showed a gastroprotective effect against noxious agents-induced gastric mucosal damage through capsaicin-sensitive afferent nerves. Our objective was to determine the pharmacokinetic (PK) characteristics and safety of rising, single oral doses of lafutidine 10 mg, 20 mg, and 40 mg in healthy Korean subjects. Methods: A double-blind, dose block randomized, placebo-controlled, parallel group, single oral dose study was conducted in 30 healthy male subjects. Three groups of ten subjects received 10 mg, 20 mg, or 40 mg dosage, respectively. Two subjects in each dose group were administered matching placebo. Serial blood samples were collected for lafutidine assay during 24 h after drug administration. Pharmacokinetic parameters were determined using noncompartmental methods. Clinical safety evaluations were performed. Results: Lafutidine was rapidly absorbed with individual $T_{max}$ values ranging from 0.5 to 2 h. Mean values by dose group for oral clearance and apparent volume of distribution were similar. Lafutidine AUC and $C_{max}$ appeared to increase proportionally with dose, and dose-normalized AUC and $C_{max}$ were similar among 10 mg, 20 mg, or 40 mg dosing groups (analysis of variance, P=0.163 and 0.244, respectively). All 5 adverse events (AEs) reported were mild. No clinically significant laboratory abnormalities, vital signs or ECG measurements were observed. Conclusions: PK linearity was demonstrated up to 40 mg dosing. Lafutidine was generally safe and well tolerated with only mild AE.

Background: Bepotastine besilate is a non-sedating, second-generation $H_1$-antagonist. It is known to be rapidly absorbed after oral administration and negligibly distributed to the brain. This study aimed to assess pharmacokinetic (PK) characteristics and safety of bepotastine besilate after oral administration in Korean healthy subjects. Methods: An open, single dose, parallel group, dose-escalation study was performed in sixteen healthy subjects. Two groups of eight subjects received either 10 or 20 mg dosage, respectively. Blood samples for PK assessments were collected till 24 hours after oral administration of bepotastine besilate. For safety assessments, clinical laboratory tests, vital signs, physical examinations, and 12-lead ECGs(electrocardiographies) were measured. Results: The average area under the concentration-time curves from time zero to infinity (AUC) were $397.12{\pm}28.56\;(Mean{\pm}SD)\;{\mu}g{\cdot}h/L$ for the 10 mg group, and $776.80{\pm}88.48\;{\mu}g{\cdot}h/L$ for the 20 mg group. The values of average $C_{max}$ were $97.19{\pm}22.72\;{\mu}g/L$ and $188.79{\pm}30.39\;{\mu}g/L$ in the 10 mg and 20 mg group, respectively. AUC and $C_{max}$ appeared to increase proportionally with the dose, and dose-normalized AUC and $C_{max}$ were similar between 10 mg and 20 mg dosing groups (t-test, P=0.647 647 and 0.777, respectively). Only one adverse event (hordeolum) was reported during this trial. No clinically significant abnormalities were observed in laboratory tests, vital signs or ECG measurements. Conclusions: Bepotastine besilate $C_{max}$ and AUC values proportionally increased with increasing dose. Bepotastine besilate was generally safe and well tolerated with only a mild adverse event.

Background: Desloratadine, a nonsedating histamine $H_1$ receptor antagonist, is an orally active major metabolite of loratadine. We investigated the pharmacokinetic (PK) characteristics of a single oral dose of desloratadine in healthy Korean male volunteers. Methods: A parallel group, rising single dose (5, 10 and 20 mg), block (dose) randomized, double-blind, placebo-controlled study was conducted in 36 healthy male volunteers. Subjects were randomized into each dose group (placebo: active drug= 2: 10 subjects). Plasma concentrations of deslorataine and its major metabolite, 3-OH desloratadine were measured till 168 hours after drug administration. The results were compared to Caucasian data from a previous study. Results: The mean $AUC_{inf}$ were 37.9, 81.8, 172.2 ${\mu}g*h/L$ and $C_{max}$ were 2.4, 5.0, 9.9 ${\mu}g/L$ in 5, 10 and 20 mg dose groups, respectively. The range of mean metabolic ratio by dose groups was $0.67{\sim}0.75$. $C_{max}$ and $AUC_{inf}$ of desloratadine and 3-OH desloratadine exhibited linear properties over a dose range of 5 to 20 mg. Mean terminal elimination half-life ($t_{1/2}$) was 25 hours for desloratadine, and 38 hours for 3-OH desloratadine. The geometric mean ratios(90% confidence interval) for Koreans to Caucasians were 1.3 (1.06-1.60) for dose-normalized $AUC_{inf}$ and 1.3 (1.11-1.51) for dose-normalized $C_{max}$; PK parameters of desloratadine in Koreans showed statistically significant differences with the PK parameters in Caucasians. However, desloratadine has a wide safety margin and flat dose-response relationship, so approximately 1.3 times higher exposure is not thought to be clinically significant. Conclusions: The PK parameters of desloratadine in Koreans were linear according to dose increments. Comparison of the $AUC_{inf}$ and $C_{max}$ values between Koreans and Caucasians indicates no clinically relevant difference that requires dosage adjustment for desloratadine in Koreans.

Methods: This study was designed to examine the job satisfaction of Clinical Research Coordinators(CRC) in a university hospital. Data were collected by self-administered questionnaires. From December 20, 2006 to January 20, 2007 one hundred forty five CRCs replied to questionnaires. All of them had been worked in hospitals located in metropolitan area. The statistical analysis was performed using t-test, ANOVA and the multiple hierarchial regression analysis in SPSS package. Results: 1) The CRCs' job satisfaction showed significant difference depending on working conditions. Offering to attend training opportunity showed significant difference and the highest score, 3.53. 2) The motive of application to the job influenced to CRCs' job satisfaction. "I like to work in research field." was scored 3.70, and "I can have spare time" was 3.68. This factor showed significant differences of job satisfaction. Especially, the job satisfaction of CRCs over two-year career got the highest score. And their satisfaction was different by the intention of occupation change 3) In the hierarchical multiple regression, job satisfaction of CRCs was influenced by the intention of occupation change, career at the current work, opportunity to attend conferences, no support four major insurances and application for spare time. The five significant factors explained 19.5% of the job satisfaction. Conclusions: We investigated the factors determining job satisfaction of CRCs. If the job satisfaction could be improved, it might bring more efficiency in clinical research.