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Bioequivalence of DilastTM Capsule to Ketas® Capsule (Ibudilast 10 mg) (케타스캅셀(이부딜라스트 10 mg)에 대한 딜라스트캡슐의 생물학적동등성)

  • Chang, Kyu-Young;Kang, Seong-Woo;Yoo, Eun-Ju;Lew, Soo-Hyun;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.37 no.3
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    • pp.197-203
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    • 2007
  • A bioequivalence study of $Dilast^{TM}$ Capsule (Chong Kun Dang Pharma. Co., Ltd.) to $Ketas^{(R)}$ Capsule (Han Dok Pharma. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty eight healthy male Korean volunteers received each medicine at the ibudilast dose of 20 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of ibudilast were monitored by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) for over a period of 36 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 36 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 was carried out using logarithmically transformed $AUC_t\;and\;C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Dilast^{TM}$ $Capsule/Ketas^{(R)}$ Capsule were $log0.93{\sim}log1.06$ and $log0.93{\sim}log1.11$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Thus, our study demonstrated the bioequivalence of $Dilast^{TM}$ Capsule and $Ketas^{(R)}$ Capsule with respect to the rate and extent of absorption.

Numerical Analysis of the Seepage from and Stability of a Mine Waste-dump Slope during Rainfall (강우시 광산폐기물 적치사면의 침투 및 안정성에 대한 수치해석)

  • Song, Young-Suk
    • The Journal of Engineering Geology
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    • v.25 no.1
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    • pp.57-66
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    • 2015
  • A numerical analysis was performed of the seepage from and stability of a mine waste-dump slope in Imgi, Busan, considering rainfall intensity. The 40-45° slope angle of the waste dump is relatively steep, and the depth of the waste dump down to bedrock is 7-8 m. The groundwater level was 6.6 m below the surface. Various laboratory tests on samples obtained from the waste dump were performed to determine the input data for seepage and stability analyses of the waste-dump slope during rainfall. The results of seepage analysis for various rainfall intensities using the SEEP/W program show that the wetting front moved down with increasing rainfall duration. When the rainfall intensity was > 50 mm/ hour and the duration was > 24 hours, the waste dump became fully saturated because the wetting front reached the groundwater level. The results of slope stability analysis coupled with seepage analysis using the SLOPE/W program show that the safety factor of the slope decreased as the wetting front moved down due to rainfall infiltration. After continuous rainfall for 5-6 hours, the safety factor of the slope suddenly decreased but then recovered and converged. The sudden decrease was induced by an increase in pore-water pressure and a decrease in matric suction down to a certain depth as the wetting front approached the potential sliding surface.

A Thermostable Protease Produced from Bacillus sp. DF 218 (Bacillus sp. DF218이 생산하는 내열성 단백질 분해효소)

  • Lee, Joung-Hee;Bai, Dong-Hoon
    • Korean Journal of Food Science and Technology
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    • v.36 no.1
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    • pp.105-110
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    • 2004
  • Microorganism (strain DF 218) producing thermostable pretense was isolated from Korean soil and compost. It was Gram-positive, rod-shaped, aerobic, and spore-forming with yellowish white colony color, Temperature range for growth at pH 6.5 was $30-65^{\circ}C$, with optimum growth at $60^{\circ}C$. pH range for growth at $60^{\circ}C$ was 5-7 with optimum of 6.5, which indicates strain DF 218 to be thermophilic. The 16S rDNA sequence of strain DF 218 had 95% sequence similarity with that of Bacillus flexus. Based on physiological properties and phylogenetic analysis, we proposed the isolated strain as Bacillus sp. DF 218. Pretense was produced aerobically at $60^{\circ}C$ for 32 hr in a medium (pH 6.5) containing 1% each trypton, glucose, and NaCl. Its molecular weight was estimated as 61 kDa, with optimum temperature and pH of $60^{\circ}C$ and 7.5, respectively.

Regional Frequency Analysis for Rainfall using L-Moment (L-모멘트법에 의한 강우의 지역빈도분석)

  • Koh, Deuk-Koo;Choo, Tai-Ho;Maeng, Seung-Jin;Trivedi, Chanda
    • The Journal of the Korea Contents Association
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    • v.8 no.3
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    • pp.252-263
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    • 2008
  • This study was conducted to derive the optimal regionalization of the precipitation data which can be classified on the basis of climatologically and geographically homogeneous regions all over the regions except Cheju and Ulreung islands in Korea. A total of 65 rain gauges were used to regional analysis of precipitation. Annual maximum series for the consecutive durations of 1, 3, 6, 12, 24, 36, 48 and 72hr were used for various statistical analyses. K-means clustering mettled is used to identify homogeneous regions all over the regions. Five homogeneous regions for the precipitation were classified by the K-means clustering. Using the L-moment ratios and Kolmogorov-Smirnov test, the underlying regional probability distribution was identified to be the generalized extreme value (GEV) distribution among applied distributions. The regional and at-site parameters of the generalized extreme value distribution were estimated by the linear combination of the probability weighted moments, L-moment. The regional and at-site analysis for the design rainfall were tested by Monte Carlo simulation. Relative root-mean-square error (RRMSE), relative bias (RBIAS) and relative reduction (RR) in RRMSE were computed and compared with those resulting from at-site Monte Carlo simulation. All show that the regional analysis procedure can substantially reduce the RRMSE, RBIAS and RR in RRMSE in the prediction of design rainfall. Consequently, optimal design rainfalls following the regions and consecutive durations were derived by the regional frequency analysis.

Bioequivalence Of SudoTM Ranitidine Hydrochloride Tablet to CuranTM Tablet (Ranitidine Hydrochloride 150 mg) (큐란 정(염산라니티딘 150 mg)에 대한 수도염산라니티딘정의 생물학적동등성)

  • Lee, Sun-Neo;Ko, Youn-Jung;Kang, Seung-Woo;Yoon, Seo-Hyun;Park, Moo-Sin;Lee, Ye-Ri;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.36 no.3
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    • pp.193-199
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    • 2006
  • A bioequivalence study of $Sudo^{TM}$ Ranitidine HCI tablet (Sudo Pharma. Ind. Co., Ltd.) to $Curan^{TM}$ tablet (Il Dong Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the ranitidine hydrochloride dose of 150 mg in a 2x2 crossover study. There was a one week wash-out period between the doses. Plasma concentrations of ranitidine were monitored by a high-turbulent liquid chromatography (HTLC) for over a period of 12 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 12 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 was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found far all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Sudo^{TM}$ Ranitidine $HCl/Curan^{TM}$ were 0.92-1.00 and 0.90-1.03, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Sudo^{TM}$ Ranitidine HCI and $Curan^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of MelaxTM Capsule to MobicTM Capsule (Meloxicam 7.5 mg) (모빅 캡슐(멜록시캄 7.5 mg)에 대한 멜락스 캡슐의 생물학적동등성)

  • Lee, Ye-Rie;Yeom, Seung-Bock;Ko, Youn-Jung;Ko, Jung-Kil;Kim, Ho-Hyun;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.5
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    • pp.413-418
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    • 2004
  • A bioequivalence of $Melax^{TM}$ capsules (Chong Kun Dang Pharm., Korea) and $Mobic^{TM}$ capsules (Boehringer Ingelheim Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 15 mg dose of meloxicam of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2\;{\times}\;2$ crossover design. Concentrations of meloxicam in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 72 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 was performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Melax^{TM}/Mobic^{TM}$ were 0.95 - 1.04 and 0.98 - 1.14, respectively. This study demonstrated a bioequivalence of $Melax^{TM}$ and $Mobic^{TM}$ with respect to the rate and extent of absorption.

Comparison of nutrients and food intakes of young children according to lunch places: based on the fifth Korea National Health and Nutrition Examination Survey (유아의 점심 식사장소에 따른 영양소 및 식품 섭취량의 비교 : 제5기 국민건강영양조사 자료를 이용하여)

  • Choi, Young-Sun
    • Journal of Nutrition and Health
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    • v.51 no.3
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    • pp.254-263
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    • 2018
  • Purpose: This study examined whether there was a difference in the nutrients and food intake of young children depending on their lunch places. Methods: The dietary survey data of the fifth Korea National Health and Nutrition Examination Survey (2010 ~ 2012) were used. The children were grouped into either a child care center lunch group (n = 728) or home lunch group (n = 592) and their nutrients and food intakes were compared. Results: No differences in the 24-hr energy intake and energy intakes from lunch and dinner according to the lunch places were observed. The percentage of breakfast energy was lower in the child care center lunch group, whereas the percentage of snack energy was higher. In children aged 3 ~ 5 years, the sodium, potassium, and vitamin C intakes were high in the child care center lunch group. The 1 ~ 2 years and 3 ~ 5 year old children's vegetable intake from lunch was significantly higher in the child care center lunch group than in the home lunch group. Children aged 3 ~ 5 years in the child care center lunch group consumed more beans and fish at lunch. The adequacy of nutrients and food diversity of child care center lunch appear better than home lunch. Conclusion: Parents and care providers need to make efforts to use diverse foods, such as vegetables and fish, in children's meals to provide balanced diets and promote healthy eating behaviors to their children.

Studios on Processing and Keeping Quality of Retort Pouched Foods (4) Preparation and Keeping Quality of Retort Pouched Seasoned Baby Clam (레토르트파우치 식품의 가공 및 품질안정성에 관한 연구 (4) 레토르트파우치 조미바지락의 제조 및 저장중의 품질안정성)

  • LEE Eung-Ho;KIM Jeong-Gyun;CHA Yong-Jun;OH Kwang-Soo;KOO Jae-Geun;KWON Chil-Sung
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.17 no.6
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    • pp.499-505
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    • 1984
  • For the purpose of obtaining basic data which can be applied to processing of retort pouched shell-fishes, retort pouched seasoned baby clam was prepared. After sand and mud were removed, and then steamed baby clams were shucked. Baby clam meats were seasoned with the mixed seasoning powder containing $3\%$ of sugar, $2.5\%$ of salt, $12\%$ of sorbitol, $0.5\%$ of monosodium glutamate and $10\%$ of smoke flavor, and then dried at $35-40^{\circ}C$ for 3 hours. After dried, the meats were vacuum packed in plastic film bag (polyester/nylon/unoriented polyproylene; $12{\mu}m/15{\mu}m/50{\mu}m,\;15{\times}17cm$), and sterilized for 12 minutes in a hot water circulating sterilzer at $120^{\circ}C$, The factors such as pH, VBN, moisture content water activity, color value (L, a, b), texture, TBA value and viable bacterial count of products were determined during storage at room temperture ($20{\pm}3^{\circ}C$). The results showed that the product could be preserved in a good condition for 120 days at $20{\pm}3^{\circ}C$. Judging from the scores of sensory evaluation on flavor, the product added smoke flavor as seasoning was the most desirable.

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Policy Effects of Secondhand Smoke Exposure in Public Places in the Republic of Korea: Evidence from PM2.5 levels and Air Nicotine Concentrations

  • Park, Eun Young;Lim, Min Kyung;Yang, Wonho;Yun, E Hwa;Oh, Jin-Kyoung;Jeong, Bo Yoon;Hong, Soon Yeoul;Lee, Do-Hoon;Tamplin, Steve
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.12
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    • pp.7725-7730
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    • 2013
  • Objective: The purpose of this study was to evaluate secondhand smoke (SHS) exposure inside selected public places to provide basic data for the development and promotion of smoke-free policies. Methods: Between March and May 2009, an SHS exposure survey was conducted. $PM_{2.5}$ levels and air nicotine concentrations were measured in hospitals (n=5), government buildings (4), restaurants (10) and entertainment venues (10) in Seoul, Republic of Korea, using a common protocol. Field researchers completed an observational questionnaire to document evidence of active smoking (the smell of cigarette smoke, presence of cigarette butts and witnessing people smoking) and administered a questionnaire regarding building characteristics and smoking policy. Results: Indoor $PM_{2.5}$ levels and air nicotine concentrations were relatively higher in monitoring sites where smoking is not prohibited by law. Entertainment venues had the highest values of $PM_{2.5}$(${\mu}g/m^3$) and air nicotine concentration(${\mu}g/m^3$), which were 7.6 and 67.9 fold higher than those of hospitals, respectively, where the values were the lowest. When evidence of active smoking was present, the mean $PM_{2.5}$ level was 104.9 ${\mu}g/m^3$, i.e., more than 4-fold the level determined by the World Health Organization for 24-hr exposure (25 ${\mu}g/m^3$). Mean indoor air nicotine concentration at monitoring sites with evidence of active smoking was 59-fold higher than at sites without this evidence (2.94 ${\mu}g/m^3$ vs. 0.05 ${\mu}g/m^3$). The results were similar at all specific monitoring sites except restaurants, where mean indoor $PM_{2.5}$ levels did not differ at sites with and without active smoking evidence and indoor air nicotine concentrations were higher in sites without evidence of smoking. Conclusion: Nicotine was detected in most of our monitoring sites, including those where smoking is prohibited by law, such as hospitals, demonstrating that enforcement and compliance with current smoke-free policies in Korea is not adequate to protect against SHS exposure.

Bioequivalence of NimegenTM Soft Capsule to RoAccutane® Soft Capsule (Isotretinoin 10 mg) (로아큐탄 연질캡슐(이소트레티노인 10 mg)에 대한 니메겐 연질캡슐의 생물학적동등성)

  • Yang, Seung-Kwon;La, Sook-Ie;Chang, Kyu-Young;Lee, Yun-Young;Yoon, Mi-Kyeong;Lew, Soo-Hyun;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.37 no.4
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    • pp.255-261
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    • 2007
  • A bioequivalence study of $Nimegen^{TM}$ soft capsule (Medica Korea Pharma. Co., Ltd.) to $RoAccutane^{(R)}$ soft capsule (Roche Korea Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty healthy male Korean volunteers received each medicine at the isotretinoin dose of 60 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of isotretinoin were monitored by a high performance liquid chromatography (HPLC) for over a period of 48 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48 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 was carried out using logarithmically transformed $AUC_t\;and\;C_{MAX}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{MAX}$ ratio for $Nimegen^{TM}/RoAccutane^{(R)}$ were $log0.860{\sim}log0.98\;and\;log0.85{\sim}log1.00$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Thus, our study demonstrated the bioequivalence of $Nimegen^{TM}\;and\;RoAccutane^{(R)}$ with respect to the rate and extent of absorption.