• Korean Journal of Clinical Pharmacy
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• v.16 no.2
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• pp.96-100
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• 2006

Korea Food and Drug Administration (KFDA) has been expediting the Biological Equivalence Examination (BEE) project to encourage generic substitution without expense of inappropriate therapeutic outcome. However, little is known about which considerations are most important in making the decision to prescribe a drug among many generic drugs. The purpose of this survey was to identify how strongly the KFDA certification of BEE influenced doctors when they make a choice between brand and generics of glimepiride preparations. Telephone survey was performed towards doctors working at local clinics by using a questionnaire. Most influential factor to doctors' decision was drug cost followed by pharmaceutical representatives, therapeutic efficacy, and review guideline for reimbursement. Advertisement of the drug was the least influential followed by KFDA certification of BEE. The meaning of BEE was best understood by relatively young doctors with specialty in surgical parts. This survey result further indicated that the doctors considered the therapeutic equivalence examination a preferred measure to expedite generic substitution.

• The Korean Journal of Applied Statistics
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• v.24 no.4
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• pp.623-631
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• 2011

A major goal of time-course microarray data analysis is the detection of groups of genes that manifest similar expression patterns over time. The corresponding numerous cluster algorithms for clustering time-course microarray data have been developed. In this study, we proposed a clustering method based on the primary pharmacokinetic parameters in the pharmacokinetics study for assessment of pharmaceutical equivalents between two drug products. A real data and a simulation data was used to demonstrate the usefulness of the proposed method.

• Journal of Pharmaceutical Investigation
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• v.24 no.2
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• pp.67-72
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• 1994

Bioequivalence (BE) test of biphenyl dimethyl dicarboxylate (DDB) tablets was performed. Normal healthy male volunteers (n = 20) were randomly divided into 2 groups, and reference $(Nissel{\circledR})$ and test $(Livital{\circledR})$ tablets of DDB $(25mg{\times}8\;Tab.\;= \;200\;mg)$ were given orally by balanced two-period cross-over design. The serum concentration was determined by high performance liquid chromatography. The pharmacokinetic parameters, AUC, $C_{max}$, and $T_{max}$ obtained after drug administration were statistically analyzed. Statistical evaluation of the data involved an analysis of variance (ANOVA) for cross-over design. The results were within 20% differences of mean value in AUC, $C_{max}$, and $T_{max}$ between reference and test tablets. The results of ANOVA showed no significant differences for "between group or subject" and "period". The test tablet was bioequivalent with the reference tablet in the AUC, $C_{max}$, and $T_{max}$.

• KSBB Journal
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• v.10 no.4
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• pp.461-467
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• 1995

In this study, the release experiments of drug were operated in the phosphate buffer solutions of pH 7.4 and pH 1.2 by using drug carriers(chitosan, chitosan hydrochloride, and sulfonated chitosan)coated by poly(DL-lactide) with prednisolone for delivery drug. The release time of drug was more delayed in pH 7.4 than in pH 1.2. The release time of according to the kinds of drug carrier was delayed in the order of chitosan, sulfonated chitosan, and chitosan hydrochloride. In short, the formulation allows biodegradable coated monolithic polymetic matrices to suppress the burst effect of the drug release mechanism, which led to the sustained release pattern.

• KSBB Journal
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• v.26 no.2
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• pp.157-164
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• 2011

Five assays for anti-HBs were compared to improve potency test of Human lgG preparations. The three commercial EIA kits were optimized including dose response curve ranges and compared by conducting a co-laboratory study. After selecting the most reproducible EIA kit, methods comparison was performed with 22 samples in 5 different days. As a result, EIA (7.7 ${\pm}$ 5.3%) and MEIA (AxSYM: 3.7 ${\pm}$ 1.9%, IMx: 1.6 ${\pm}$ 0.8%) showed precision and accuracy (100.1 ${\pm}$ 12.6%). Therefore, the validated EIA assay was established and it is believed to be comparable to current MEIA.

• Biomolecules & Therapeutics
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• v.8 no.3
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• pp.262-268
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• 2000

The bioequivalence of two tiropramide products was evaluated in 18 health male volunteers following oral administration. Test product was Tira $m^{R}$ tablet (Shin Poong SP-102) (Shin Poong Pharm. Co., Ltd.) and reference product was Tirop $a^{R}$ tablet (Dae Woong Pharm. Co., Ltd.) One capsule of the test and reference product containing 100 mg of tropramide.hydrochloride was administered to the volunteers by randomized two period cross-over study (2 $\times$ 2 Latin square method). The drug concentration in plasma was determined by GC/MS for over a period of 12hours after administration. Analysis of variance reveal that there are no differences in AUC (area under the plasma concentration-time curve from time zero to infinity), Cmax (maximum plasma concentration) and Tmax (time to reach Cmax). The differences of mean AUC, Cmax and Tmax between two products were 3.85, 1.47 and -3.6%, respectively. Minimum detectable differences (%) at $\alpha$=0.1 were all less than 20% given as a guideline (18.07, 17.00 and 20.69% for AUC, Cmax and Tmax, respectively). From these results, the two products are bioequivalent.ent.

• Journal of Navigation and Port Research
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• v.35 no.10
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• pp.817-822
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• 2011

Lab scale experiment study was carried out for biological treatment process development in cruise. SBR(Sequence Batch Reactor) process with BM(Beneficial Microorganisms) was investigated for practical application on shipboard sewage treatment. From the results it was suggested that SBR process with BM might be a suitable process for cruise sewage treatment in terms of decrease in odorous compounds, maintenance of useful microorganisms and creating special environmental conditions. By adding BM to SBR system, odor unit of sulfur compounds was about 20 times reduced.

• The Korean Journal of Pesticide Science
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• v.4 no.3
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• pp.68-74
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• 2000

Penicillium oxalicum (PENOX) has shown the potential as a biocontrol agent(5CA) for control of a weed, clover(Trifolium repens L.) in grass plots. The bioherbicidal activity may be due to germinative and growth capacities and substrate availability of the agent over a range of environmental factors. The influences of different water activities($0.94{\sim}0.995\;a_w$) and temperatures($18{\sim}30^{\circ}C$) on mycelial growth, conidial germination, sporulation oil 2% MEA(malt extract agar) adjusted to different water activities with glycerol, and carbon source utilization using BIOLOG GN MicroPlate were determined in vitro. Decreases in $a_w$ on MEA caused a reduction in mycelial growth and conidial germination depending on temperature. The mycelial growth of PENOX was greatest at $30^{\circ}C/0.995\;a_w$. At some lowered water activity($0.97\;a_w$), the growth was similar between 25 and $30^{\circ}C$, and considerably decreased at lowered temperature($20^{\circ}C$). The germination rate was also greatest at $30^{\circ}C/0.995\;a_w$. Lag phase times for PENOX at $18^{\circ}C$ on MEA were >6hrs at tile whole $a_w$ level tested, and at 18 and $25^{\circ}C$ they were >18hrs and >12hrs at $0.94\;a_w$, respectively. However, its sporulation was some better at $0.97\;a_w$ than $0.995\;a_w$ or $0.94\;a_w$, and better at $20^{\circ}C$ than $30^{\circ}C$. In contrast, the number of carbon sources(niche size) utilized by PENOX varied with $a_w$ and temperature. Under some water stress condition($0.95\;a_w$), the agent utilized smaller number of carbon sources than $0.995\;a_w$ depending on temperature. The niche size at 0.995 and $0.95\;a_w$ were highest at $25^{\circ}C$, and showed 86 and 65, respectively. At $30^{\circ}C$, the niche size at 0.995 and $0.95\;a_w$ showed 84 and 50, respectively. There was no carbon source utilized by PENOX at $0.90\;a_w$ regardless of temperature. These information of tile fungal ecophysiology will be useful for the effective development of BCA.

• Korean Journal of Clinical Pharmacy
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• v.15 no.1
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• pp.41-45
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• 2005

심바스타틴은 cholesterol 생합성 과정에서 속도 조절 효소인 HMG-CoA reductase의 강력한 상경적 길항약으로서 고지혈증 치료에 널리 쓰이는 약물이다. 심바스타틴 제제인 MSD 사의 조코 20 mg정을 대조약으로 하여 시험약인 유영 제약의 엘바스타 20mg정의 생물학적 동등성 평가를 하기 위해 22명의 건강한 지원자를 모집하였다. 지원자를 두 군으로 나누어 2정씩 투여하였고 $2{\times}2$ 교차시험을 실시하였다. 심바스타틴의 혈장 중의 농도를 정량하기 위하여 발리데이션된 LC/MS/MS를 사용하였다. 채혈 시간은 투약 전 및 투약 후 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 시간에 걸쳐 총 12시점에 걸쳐 시행하였다. 생물학적 동등성을 판정하기 위한 파라미터로 12시간까지의 혈장 중 농도곡선 하 면적 ($AUC_{12hr}$)과 최고 혈중 농도($C_{max}$)를 사용하였다. 12시간 까지의 혈중 농도 곡선 하 면적의 기하 평균은 $17.30ng{\cdot}ml/hr$(시험약)과 $17.35ng{\cdot}ml/hr$(대조약)으로 나타났다. 최고 혈중 농도의 경우 각 각 5.08 ng/ml(시험약)과 5.20 ng/ml(대조약)으로 관찰 되었다. $AUC_{12hr}$의 경우 로그변환한 평균치 차의 $90{\%}$ 신뢰구간이 log0.8510 - log1.1694이었고, $C_{max}$의 경우 log0.8176 - log1.1649로 계산되어 두 항목 모두 log0.8-log1.25이어야 한다는 식품의약품 안전청과 FDA의 기준을 모두 만족시켰다. 이상의 결과를 종합하면 시험약 엘바스타 정 20mg은 대조약 조코정 20 mg에 대하여 생물학적 동등한 것으로 판정되었다.트리머 전기비저항 탐사를 수행하였다. 이를 통해 하저에 케이블을 설치하는 방식에 비해 매우 신속하고 경제적으로 하저에 분포하는 이상대의 분포범위와 발달방향을 규명할 수 있었다.대에 대해 가장 효과적이다. 모델과 현장 적용 결과들을 통해 GRM SSM 방법을 이용하여 불규칙한 굴절면을 가진 지층들에 대해 좀 더 신뢰할 수 있는 정밀한 탄성파 속도를 산출할 수 있음을 보여주고 있다.별한 주의를 기울여야 한다.EX>$\alpha/\beta$=10인 경우 $62.0\~121.9\;Gy_{10}$ (중앙값: $93.0\;Gy_{10}$)의 분포를, ${\alpha/\beta}=3$인 경우 $93.6\~187.3\;Gy_3$ (중앙값=$137.6\;Gy_3$ )의 분포를 보였다. MD-BED $Gy_3$는 직장합병증 발생과의 관계는 통계적으로 유의하였고, 방광합병증과는 유의하지 않았다. 직장합병증과의 연관성은 MD-BED $Gy_3$보다 개별 환자의 직장전벽 총 선량 BED값인 R-BED $Gy_3$가 훨씬 더 높았다. 요도카테터 풍선의 후방지점이 대변하는 방광의 총 선량 BED값인 V-BED $Gy_3$도 방광합병증과 경향성 테스트에서 통계적 유의성을 보였다. 하지만, 어떠한 방사선선량도 골반제어율과 의미 있는 상관관계를 보이지 않았다. 본 기관에서 주치의의 선호도에 따라 강내근접치료가 외부방사선치료의 중간에 시행되는 형태인 샌드위치기법과 외부방사선치료 후반부에 시행되는 순차적 기법으로 구분하였을 때, 두 방식간 치료성적 및 합병증의 차이는 없었다. 총 치료기간에 대한 분석에서는 치료기간이 길어질수록 재발 위험이 커지는 경향을 보였으나, 나이 및 병기, 종양의 크기, MD-BED $Gy_{10}$

• KSBB Journal
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• v.24 no.2
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• pp.113-121
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• 2009

As one of the new areas of 'omics' technology, there is increasing interest in metabolomics, which involves the analysis of low-molecular-weight compounds in cells, tissues, and biofluids, and considers interactions within various organisms and reactions of external chemicals with those organisms. However, metabolomics research is still at a fundamental stage in Korea. Therefore, the purpose of this study was to establish a strategic long-term plan to revitalize the national metabolomics approach and obtain the elementary data necessary to determine a policy for effectively supporting metabolomics research. These investigations clarified the state of metabolomics study both in Korea and internationally, from which we attempted to find the potentiality and fields where a metabolomics approach would be applicable, such as in medical science. We also discuss strategies for developing metabolomics research. This study revealed that promoting metabolomics in Korea requires cooperation with metabolomics researchers, acquisition of advanced technology, capital investment in metabolomics approach, establishment of metabolome database, and education of metabolome analysis experts. This would reduce the gap between the national and international levels of metabolomics research, with the resulting developments in metabolomics having the potential to greatly contribute to promoting biotechnology in Korea.