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Bioequivalence of AmbrectTM Tablet to MucopectTM Tablet (Ambroxol hydrochloride 30 mg) (뮤코펙트 정(염산암브록솔 30 mg)에 대한 암브렉트 정의 생물학적 동등성)

  • Yoo, Jeong-Yeon;Joung, Sun-Koung;Choi, Mee-Hee;Han, Sang-Beom;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.33 no.3
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    • pp.215-221
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    • 2003
  • A bioequivalence study of $Ambrect^{TM}$ tablets (Dong Wha Pharm. Ind. Co., Ltd.) to $Mucopect^{TM}$ tablets (Boehringer Ingelheim Korea, Ltd.) was conducted according to the guideline of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korea volunteers received each medicine at the ambroxol hydrochloride dose of 30 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of ambroxol were monitored by a high-performance liquid chromatography for over a period of 24 hours after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 hr) was calulated 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 $Ambrect^{TM}/Mucopect^{TM}$ were 0.89-1.01 and 0.89-1.02, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Ambrect^{TM}\;and\;Mucopect^{TM}$ with respect to the rate and extent of absorption.

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.

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 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.

The Effect of Hypocarbic Priming Solutions on Extracorporeal Circulation during Open Heart Surgery (개심술시 충전액의 저이산화탄소 분압이 체외순환에 미치는 영향)

  • Song, Sun-Ok;Suh, Jung-Kook;Kim, Heung-Dae
    • Journal of Yeungnam Medical Science
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    • v.1 no.1
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    • pp.101-106
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    • 1984
  • Before beginning the extracorporeal circulation, perfusionists should supply oxygen into the oxygenator and establish blood flow through the blood line of the heart-lung machine. But these manipulation can induce severe hypocarbic state of priming solutions due to wash out of $CO_2$ gas in the solution. This study was carried out to examine the relationship of blood gas changes between hypocarbic priming solutions and body circulation in 15 patients undergoing open heart surgery with extracorporeal circulation. $PaCO_2$, pH, buffer base and $PaO_2$ were measured from priming solutions before and 15 minutes after the extracorporeal circulation. The results were as follows; 1) Before the extracorporeal circulation, mean $PaCO_2$ level was $12.1{\pm}7.8mmHg$ in the priming solution. However, 15 minutes after extracorporeal circulation, the $PaCO_2$ level was maintained at $35.7{\pm}5.7mmHg$. 2) pH in the priming solution was variable from 6.93 to 7.99 (mean $7.45{\pm}0.29$), but after 15 minutes it was ranged from 7.28 to 7.42 (mean $7.35{\pm}0.05$). 3) Mean buffer base level in the priming solution was $7.9{\pm}3.5mmol/l$, but after 15 minutes, it was $19.6{\pm}1.2mmol/l$. 4) Mean $PaO_2$ level in the priming solution was $667.1{\pm}45.6mmHg$, but after 15 minutes, it was $280.7{\pm}131.7mmHg$.

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Bioequivalence of LANIDIEM® Tablet 4 mg to Vaxar® Tablet 4 mg(Lacidipine 4 mg) (박사르®정 4 밀리그램(라시디핀 4 mg)에 대한 라니디엠®정 4 밀리그램의 생물학적동등성)

  • Lee, Yun-Young;Kim, Hye-Jin;La, Sookie;Cho, Kyung-Hee;Jang, Moon-Sun;Park, Young-Joon;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.40 no.2
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    • pp.125-131
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    • 2010
  • A bioequivalence study of LANIDIEM$^{(R)}$ tablet 4 mg (Samil. Co., Ltd.) to Vaxar$^{(R)}$ tablet 4 mg (GlaxoSmithKline Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Forty healthy male Korean volunteers were enrolled in the study and thirty six volunteers completed the study according to the protocol. Thirty six volunteers received each medicine at the lacidipine dose of 4 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of lacidipine were monitored by a high performance liquid chromatography - tandem mass spectrometry (LC-MS/MS) for over a period of 24 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 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 LANIDIEM$^{(R)}$/Vaxar$^{(R)}$ were log 0.8102~log 1.0417 and log 0.8493~log 1.1439, respectively. These values were within the acceptable bioequivalence intervals of log 0.80~log 1.25. Thus, our study demonstrated the bioequivalence of LANIDIEM$^{(R)}$ tablet 4 mg and Vaxar$^{(R)}$ tablet 4 mg with respect to the rate and extent of absorption.

Bioequivalence of RoxithrinTM Tablet to RulidTM Tablet (Roxithromycin 150 mg) (루리드 정(록시스로마이신 150 mg)에 대한 록시스린 정의 생물학적동등성)

  • Joung, Sun-Koung;Lee, Yun-Young;Cho, Tae-Seob;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.34 no.3
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    • pp.209-214
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    • 2004
  • A bioequivalence study of $Roxithrin^{TM}$ tablet (Kukje Pharma. Ind. Co., Ltd.) to $Rulid^{TM}$ tablet (Han Dok 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 roxithromycin dose of 300 mg in a $2{\times}2$ crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography 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 cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Roxithrin^{TM}/Rulid^{TM}$ were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of $Roxithrin^{TM}$ and $Rulid^{TM}$ with respect to the rate and extent of absorption.

A Study on High Strength Nitrogen Wastewater Treatment and Sludge Granulation Characteristics in a Pilot-scale Air-lift Sequencing Batch Reactor (파일럿 규모의 공기 유동 연속회분반응기에서 고농도 질소제거 및 슬러지 그래뉼화 특성 연구)

  • Lee, Soochul;Kim, Dong-Jin
    • Clean Technology
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    • v.18 no.4
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    • pp.398-403
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    • 2012
  • Selective nitrification and granulation have been carried out in a pilot scale air-lift sequencing batch reactor (SBR) for stable and economical nitrogen removal from wastewater. The SBR showed about 100% nitrification efficiency up to 1.0 kg ${NH_4}^+-N/m^3{\cdot}d$, about 90% efficiency at 1.0-2.0 kg ${NH_4}^+-N/m^3{\cdot}d$, and it was less than 90% when the load was higher than 2.0 kg ${NH_4}^+-N/m^3{\cdot}d$. Nitrite accumulation was induced by selective inhibition of nitrite oxidizing bacteria by free ammonia inhibition and dissolved oxygen limitation. For the purpose, high nitrite ratio (> 0.95) was obtained by keeping the pH higher than 8.0 and dissolved oxygen lower than 1.5 mg/L. In addition, sludge granulation was achieved by keeping reactor settling time to 5 minutes to wash out poor settling sludge and to promote the growth of granulation sludge. The operation accelerated sludge granulation and the sludge volume index (SVI) decreased and stably maintained to less than 75 in 60 days.

Bioequivalence of BestidineTM Tablet to Dong-A GasterTM Tablet (Famotidine 20 mg) (동아가스터 정(파모티딘 20 mg)에 대한 베스티딘 정의 생물학적동등성)

  • Park, Chang-Hun;Joung, Sun-Koung;Choi, Mee-Hee;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.6
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    • pp.505-511
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    • 2004
  • A bioequivalence study of $Bestidine^{TM}$ tablets (Choong Wae Pharma. Corp., Korea) to Dong-A $Gaster^{TM}$ (Dong-A Pharmaceutical Co., Ltd., Korea) tablets was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the famotidine dose of 40 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of famotidine were monitored by a high-performance liquid chromatography for over a period of 12 hours after the 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 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 Cmax ratio for $Bestidine^{TM}/Gaster^{TM}$ were log 0.90-log 1.06 and log 0.98-log 1.20, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Bestidine^{TM}$ and $Gaster^{TM}$ with respect to the rate and extent of absorption.

'Cook and Restaurant' reality program, structure, representation, and its cross-cultural implications: A comparative study between and of tvN ('요리 및 식당'의 리얼리티 프로그램의 구성과 재현의 의미와 문화 함축성 - tvN <윤식당1>과 <윤식당2>에 대한 기호학적 비교분석)

  • Lee, Ji Hye;Baek, Seon-Gi
    • 기호학연구
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    • no.56
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    • pp.71-107
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    • 2018
  • The purpose of this study was to find out the presentation of food and cooking process shown through the media and its cultural implications by comparing and analyzing seasons 1 and 2 of , tvN's reality program which has gained high viewer ratings and sympathy from the viewers. In light of the existing documents, the research reviewed the social and cultural meanings implied through a series of processes of "the act of cooking- the act of providing food - the act of having a meal."The authors concerned narrative structure of the program, paradigmatic analysis, actantial analysis, and analysis by applying the culinary triangle of $L{\acute{e}}vi$-Strauss were conducted, in order to find out the difference between seasons 1 and 2 of the . As a result of semiotic analysis on the programs, by focusing on the value of composure and slowness which may be felt through the simple everyday lives and travelling by running a Korean restaurant in a foreign country, the reality program revealed the changed consumption behaviors for Korean food, and the evolutionary process of cooking and the act of providing food reflecting the above. Meanwhile, the transformation of the Korean food may mean the "statelessness of Korean food" hidden under the name of localization or globalization. Furthermore, although the program intended to put up globalization of Korean food, the uniqueness of the Korean food wash armed, and this is the reason why it needs to be examined whether Korean food was used simply for entertainment in the program. Also, the program showed limitations such as drawing cultural inferiority as the motive for watching the program.