• Biomolecules & Therapeutics
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• 제8권3호
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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.

• 한국임상약학회지
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• 제9권1호
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• pp.44-48
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• 1999

The bioequivalence of two aceclofenac tablets was evaluated in 14 normal volunteers (age $21\sim29$ yrs) following oral administration. The test product was 'Apental tablet' made by Asia Pharmaceutical Co. and the reference was 'Airtal tablet' made by Daewoong Pharmaceutical Co. After one tablet containing 100 mg aceclofenac was administered, blood was taken at predetermined time intervals and the concentration of the drug in plasma was quantitated with an HPLC method. AUC, $C_{max}\;and\;T_{max}$ were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC, $C_{max}\;and\;T_{max}$ between two products were $4.23\%,\;2.15\%\;and\;0\%$, respectively. The powers for AUC,$\;C_{max}\;and\;T_{max}\;were\;>90\%,\;>90\%\;and\;85.8\%$, respectively. Confidence intervals were within $\pm20\%$ for three parameters. All of these parameters met the criteria of KFDA for bioequivalence, indicating that 'Apental tablet' is bioequivalent to "Airtal tablet".(Kor. J. Clin. Pharm. 1999; 9(1): 44-48)

• 약학회지
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• 제48권5호
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• pp.297-302
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• 2004

The purpose of the present study was to evaluate the bioequivalence of two cimetidine tablets, Tagamet (Yuhan Pharm. Co., Ltd.) and Nex (Bi-nex Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cimetidine release from the two cimetidine tablets in vitro was tested using KP Apparatus I method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solutions and water). The dissolution profiles of two cimetidine tablets were very similar at all dissolution media. Twenty four healthy male volunteers were divided into two groups with a randomized $2{\times}2$ cross-over study. After four tablets (800 mg cimetidine) were orally administrated, blood was taken and the concentrations of cimetidine in serum were determined using HPLC with UV detector. The pharmacokinetic parameters such as $AUC_{t}$, $C_{max}$ and $T_{max}$ were determined. The result showed that the differences in $AUC_{t}$, and $C_{max}$ between two cimetidine tablets based on the Tagamet were -6.82% and -12.98%, respectively. There were no sequence effects between two tablets in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., log(0.90)log(0.97) and log(0.82)log(0.93) for $AUC_{t}$ and $C_{max}$, respectively), indicating that Thrumetin tablet was bioequivalent to Tagamet tablet.

• Journal of Pharmaceutical Investigation
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• 제38권4호
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• pp.277-282
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• 2008

The purpose of the present study was to evaluate the bioequivalence of two topiramate tablets, Topamax tablet (Janssen Korea. Co., Ltd., Seoul, Korea, reference drug) and Topamin tablet (Myungmoon Pharm. Co., Ltd., Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received one tablet at the dose of 100 mg topiramate in a $2{\times}2$ crossover study. There were two-weeks washout period between the doses. Plasma concentrations of topiramate were monitored by an LC-MS/MS for over a period of 96 hr after administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 96 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals of the $AUC_t$, ratio and the $C_{max}$ ratio for Topamin/Topamax were $\log0.88{\sim}\log1.02$ and $\log0.87{\sim}\log1.03$, respectively. These values were within the acceptable bioequivalence intervals of $\log0.80{\sim}\log1.25$. Taken together, our study demonstrated the bioequivalence of Topamax and Topamin with respect to the rate and extent of absorption.

• 대한환경공학회지
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• 제30권11호
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• pp.1161-1169
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• 2008

생물학적 처리방법인 biofiltration을 이용하여 1차 기질 toluene의 존재여부에 따른 TCE와 PCE의 제거율을 비교하였다. 그리고 TCE와 PCE의 제거과정에 관련된 미생물의 군집변화를 조사하였다. TCE와 PCE혼합증기 제거율을 순치시킨 슬러지를 메디아 표면에 부착한 biofilter B를 이용해서 1차 기질로서 toluene증기 공급이 없는 상태에서 TCE/PCE 혼합증기제거율을 조사하고 또한 toluene증기로 순치시킨 슬러지를 부착한 별도의 biofliter A에서 1차 기질로서 toluene증기를 공급하는 상태에서 TCE/PCE 혼합증기의 제거율을 조사한 결과 (i) biofilter운전초기에는 PCE제거율이 TCE제거율보다 현저히 높지만, biofilter운전 지속기간의 증가에 따라 두 물질의 제거율이 증가하다가 나중에는 두 가지 물질의 제거수준이 비슷해진 상태에서 정체되는 경향이 있고, 1차 기질로서 toluene증기를 공급하지 않은 경우가 공급한 경우보다 현저히 TCE/PCE 제거율이 높으며, 두 물질의 생물여과에 의한 제거율이 동등수준에 도달하는 시간이 1차 기질을 공급하는 경우에 공급하지 않는 경우보다 빠르게 도달하였다. 이 실험은 (ii)일부의 toluene 분해 미생물이 TCE와 PCE 증기 등 염소화 휘발성 유기물 증기의 분해에도 관여하고, TCE/PCE 증기의 생물학적 저감과정에서 공동대사가 반드시 필요하지는 않는 것임을 시사한다. DGGE밴드의 16S rDNA의 염기서열을 결정한 결과 (i) uncultured alpha proteobacterium, uncultured Desulfitobacterium sp., uncultured Rhodobacteraceae bacterium, Cupriavidus necator, Pseudomonas putida 등이 toluene 분해 미생물들이었고 (ii) alpha proteobacterium HTCC396이 TCE 제거미생물이고, (iii) Desulfitobacterium sp.이 PCE 분해에 관여하는 것으로 추정된다. (iv) 특히 uncultured Desulfitobacterium sp.은 toluene뿐만 아니라 다양한 염소계 화합물을 제거시킬 수 있는 미생물임이 확인되었다.

• 원예과학기술지
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• 제29권3호
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• pp.247-254
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• 2011

제초제 저항성 유전자를 국내 장려품종 감자인 '대지'에 도입하여 제초제 저항성 감자계통들을 개발하였으며, 그 중에서 농업적 형질이 우수하며 실용화 가능성이 큰 계통을 선발하기 위하여 3년간 포장 검정을 실시하였다. 제초제 저항성 감자 4계통 중에서 가장 상업화에 적합한 Bar 3 계통을 선발하였으며, Bar 3 계통은 비형질전환 감자인 '대지'와 비교하여 수량성과 주요 작물학적인 특성, 영양학적 특성 및 충에 대한 반응에서 차이를 발견할 수 없었고 두 감자계통과 품종의 실질적 동등성을 확인할 수 있었다. Bar 3 계통은 5배의 고농도 제초제 처리에서도 피해를 나타내지 않았으며, 형질전환 후 세대가 진행되는 동안의 수량과 식물학적인 특성은 비슷한 경향을 나타내었다. Bar 3 계통은 더뎅이병과 실금이나 2차 생장과 같은 생리적 장해 발생률이 낮았으며, 그 이유는 명확하게 구명되지 않았으나, Bar 3 계통과 같은 제초제 저항성 감자를 사용할 경우 감자 재배지역에서의 더뎅이병 발생과 토양 유실 문제를 줄일 수 있을 것으로 판단되었다. 비형질전환 감자와 형질전환 Bar 3 계통의 영양학적 특성(무기성분, 비타민 C와 아미노산 함량)과 해충(파밤나방)에 대한 반응을 분석비교한 결과, 두 감자 계통과 품종의 차이를 발견할 수 없었다.

• 한국임상약학회지
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• 제18권2호
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• pp.106-113
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• 2008

The aim of this study was to evaluate the bioequivalence of two domperidone preparations. Bioequivalence assessment was conducted on 34 healthy volunteers who received two tablets (Domperidone Maleate, 12.72 mg/tablet) in the fasting state, in a randomized balanced $2{\times}2$ cross-over study design. This whole study was performed according to the implementation guidelines of the Korea Food Drug Administration. After dosing of two tablets, blood samples were collected serially for a period of 36 hours. Plasma was analyzed for domperidone by using LC/MS/MS assay method. The analysis system was validated in specificity, accuracy, precision, and linearity. $AUC_t$, (the area under the plasma concentration-time curve from the zero-time to 36 hr) was calculated through the trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma domperidone concentration-time data of each volunteer. No significant sequence effect was found for the bioavailability parameters indicating that the cross-over design was properly performed. The 90%-Confidence intervals of the $AUC_t$ ratio and the $C_{max}$ were from log 0.8007 to log 1.1240 and log 0.8645- log 1.2483, respectively. These values were within the acceptable bioequivalence intervals between 0.80 and 1.25. Therefore, this study demonstrated that two formulations have bioequivalence with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• 제35권1호
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• pp.45-50
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• 2005

The purpose of the present study was designed to evaluate the bioequivalence of two ofloxacin tablets, Tarivid (Jeil Pharm. Co., Ltd.) and Favid (ILHWA Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, $23.67{\pm}3.12$ year in age and $68.50{\pm}7.23$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After four tablets containing 100 mg of ofloxacin were orally administered, blood was taken at predetermined time intervals and concentrations of ofloxacin in plasma were determined using HPLC. Pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$ and untransformed $T_{max}$. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log 0.8 to log 1.25 (e.g., $log0.94{\sim}log1.04\;and\;log0.90{\sim}log1.07\;for\;AUC_t\;and\;C_{max}$, respectively). The major parameters, $AUC_t$, and $C_{max}$, met the criteria of KDFA for bioequivalence indicating that Favid tablet is bioequivalent to Tarivid tablet.

• Journal of Pharmaceutical Investigation
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• 제35권3호
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• pp.187-192
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• 2005

The purpose of the present study was designed to evaluate the bioequivalence of two benidipine hydrochloride tablets, Codipine (Youngjin Pharm. Co., Ltd.) and Benipine (Myungmoon Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, $23.00{\pm}1.82$ year in age and $70.08{\pm}9.59$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 4 mg of benidipine hydrochloride were orally administered, blood was taken at predetermined time intervals and concentrations of benidipine in plasma were determined using LC-MS/MS. Pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, and $C_{max}$. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log0.8 to log1.25 $(e.g., \;log1.04{\sim}log1.24\;and\;log0.91{\sim}log1.09$ for $AUC_t$, and $C_{max}$ respectively). The major parameters, $AUC_t$ and $C_{max}$, met the criteria of KDFA for bioequivalence indicating that Benipine tablet is bioequivalent to Codipine tablet.

• Journal of Pharmaceutical Investigation
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• 제37권4호
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• pp.249-254
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• 2007

The purpose of the present study was to evaluate the bioequivalence of two baclofen tablets, $Baclan^{TM}$ tablet (Yooyoung Pharm. Co., Ltd., Seoul, Korea, reference drug) and Taepyungyang Baclofen tablet (Pacificpharma Corporation, Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received three tablets containing baclofen 10 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of baclofen were monitored for over a period of 24 hr after the administration by using an LC-MS/MS. $AUC_t,\;C_{max}\;and\;T_{max}$ were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t\;and\;C_{max}$. The 90% confidence intervals of the $AUC_t$ and the $C_{max}$ for Taepyungyang $Baclofen/Baclan^{TM}$ were $log0.92{\sim}log1.06\;and\;log1.03{\sim}log1.22$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. It was concluded that Taepyungyang Baclofen tablet was bioequivalent to $Baclan^{TM}$ tablet, in terms of both rate and extent of absorption.