• Journal of Pharmaceutical Investigation
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• 제34권5호
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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.

• Journal of Pharmaceutical Investigation
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• 제37권4호
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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.

• Journal of Pharmaceutical Investigation
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• 제34권3호
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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.

• Journal of Pharmaceutical Investigation
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• 제34권4호
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• pp.319-325
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• 2004

A bioequivalence of $Etodol^{TM}$ tablets (Yuhan corporation) and $Kuhnillodine^{TM}$ tablets (Kuhnil Pharm. Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 mg dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2{\times}2$ crossover design. Concentrations of etodolac 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 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 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 $Etodol^{TM}/Kuhnillodine^{TM}$ were 1.01-1.10 and 0.87-1.06, respectively. This study demonstrated a bioequivalence of $Etodol^{TM}$ and $Kuhnillodine^{TM}$ with respect to the rate and extent of absorption.

• 한국콘텐츠학회논문지
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• 제12권3호
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• pp.322-334
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• 2012

본 연구는 기업 내 서비스신뢰, 직무몰입, 고객서비스행동, 경영성과 간의 관계를 검증함으로써 종업원의 기업에 대한 신뢰가 어떻게 경영성과에 영향을 미치는가를 확인하고 설명하는데 있다. 본 조사의 설문은 국내 주요 제약사의 판매원으로부터 자료를 수집하였으며, AMOS 18.0을 이용하여 구조방정식모형분석으로 제기된 연구가설을 검증하였다. 분석결과, 기업 내 서비스신뢰는 직무몰입과 경영성과에 긍정적인 영향을 미친 반면, 고객서비스행동에는 부정적인 영향을 주었다. 그리고 고객서비스행동은 경영성과에 긍정적인 영향을 미치는 것으로 나타났다. 따라서 기업 내 서비스신뢰는 경영성과에 직접적인 영향을 주었고, 또한 직무몰입과 고객서비스행동을 통해 유의한 영향을 주었다. 결론적으로 정리하면, 종업원이 자신이 속한 조직에서 직무에 헌신할 때 고객에 대한 서비스행동이 높아지며 경영성과도 성취될 수 있음을 확인하였다. 따라서 판매를 통한 높은 수준의 경영성과를 성취하기 위해서는 종업원의 직무에 대한 몰입을 강화해야 할 것이다.

• 한국자원식물학회:학술대회논문집
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• 한국자원식물학회 2019년도 춘계학술대회
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• pp.116-116
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• 2019

Thalictrum rochebrunianum var. grandisepalum (TRG) is a Korean endemic plant, and it is widely used for edible, medicinal, landscape materials. In this study, we examined the protein and mRNA expression levels of MITF, tyrosinase, TRP-1 and TRP-2 by TRG extract (TRGE) in IBMX-treated melanocytes to evaluate the possibility of using TRG as a whitening material. IBMX were reported as melanin synthesis enhancers. It could increase intracellular melanin synthesis by activation of the microphthalmia-associated transcription factor (MITF) signaling pathway. TRGE did not show cytotoxicity at concentrations below $100{\mu}g/ml$ in B16F10 cells. TREG dose-dependently inhibited protein and mRNA levels of MITF, tyrosinase, TRP-1 and TRP-2. Therefore, we suggest that TRGE is an important natural resource for cosmetic raw materials for whitening function.

• 한국사회복지학
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• 제57권3호
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• pp.5-30
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• 2005

세계화는 제약정책에 모순적인 영향을 미친다. 세계화에 따른 '국민적 경쟁국가'로의 변화는 약제비 절감 정책을 강화하는 한편 다국적 제약자본의 영향에 의한 WTO TRIPS 협정은 신약에 대한 특허 보호를 강화하여 약제비를 증가시킨다. 현재 다국적 제약자본의 이해를 반영하는 초국적 기구(예로, 유럽연합)가 산업적 목표 때문에 국민국가 제약정책에 규제를 가함으로써 국민국가의 약제비 절감 정책의 자율성이 침해당하고 있는 실정이다. 우리나라도 예외는 아니다. 1990년대 후반까지 우리나라 제약정책의 특징은 성장제일주의 이데올로기에 의한 원가수준의 약제비 통제 정책이었으며 이는 우리나라의 고유한 발전국가적 정책수단이었다. 그러나 세계화로 인한 다국적 제약자본의 힘의 강화는 우리나라 제약정책 자율성을 침해하고 있다. 값비싼 수입의약품은 건강보험 급여 목록에서 제외되었으나 미국 정부의 오랫동안의 압력에 의해 1999년부터 수입의약품도 건강보험 급여 목록에 등재되었다. 또한 의약분업 실시 이후 값비싼 고가약 사용이 증가하자 건강보험 재정절감 차원에서 참조가격제 도입 방안이 마련되었으나 미국 정부 및 다국적 제약회사의 압력에 의해 제도 실시가 유보되어졌다. 뿐만 아니라 미국 정부의 압력에 의해 우리나라 보건의료정책 결정 과정에 영향을 미치는 워킹그룹이 만들어지게 되었다. 지금까지 세계화와 관련된 논의들은 주로 세계화에 따른 국민적 경쟁국가로의 변화가 복지지출을 축소시켰는가에 관한 것들이었다. 그러나 본 연구는 세계화가 약제비 절감정책을 통해 보건의료비 지출을 감소시킨 측면 뿐만 아니라 세계화가 민간영리 복지서비스 제공자인 다국적 제약자본의 힘을 강화시켜 복지지출을 증가시키는 측면에도 주목하였다. 본 연구는 세계화가 일국의 제약정책에 미치는 모순적인 측면에 주목하면서 이 모순이 어떻게 다국적 제약자본의 이해로 관철되는지를 우리나라의 사례를 통해 살펴보았다.

• Journal of Pharmaceutical Investigation
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• 제33권3호
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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.

• Journal of Pharmaceutical Investigation
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• 제36권3호
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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.

• Journal of Pharmaceutical Investigation
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• 제40권2호
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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.