• Journal of Pharmaceutical Investigation
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• 제33권3호
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• pp.237-243
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• 2003

Erdosteine, the thiol derivatives chemically related to cysteine, is a mucolytic and mucoregulator agent which modulates mucus production and viscosity and increases mucociliary transport. The purpose of the present study was to evaluate the bioequivalence of two erdosteine capsules, Erdos (Dae Woong Pharmaceutical Co., Korea) and Erblon (Kuhn Il Pharmaceutical Co., Korea), according to the guidelines of Korea Food and Drug Administration (KFDA). The erdosteine release from the two erdosteine capsules in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four healthy male subjects, $23.33{\pm}2.06$ years in age and $66.18{\pm}8.19\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three capsules containing 300 mg as erdosteine were orally administered, blood was taken at predetermined time intervals and the concentations of erdosteine in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the 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 $T_{max}$. The results showed that the differences between two formulations based on the Erdos were 0.20%, 1.10% and -9.44% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) $(e.g.,\;log(0.94){\sim}log(1.22)\;and\;log(0.92){\sim}log(1.20)\;for\;AUC_t\;and\;C_{max},\;respectively$. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Erblon capsule and Erdos capsule are bioequivalent.

• Journal of Pharmaceutical Investigation
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• 제33권4호
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• pp.311-317
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• 2003

Felodipine is a calcium antagonist that lowers blood pressure by reducing peripheral resistance by meas of a direct, selective action on smooth muscle in arterial resistance vessels. Futhermore, it have been approved for the effective in angina pectoris and cardiac failure. The purpose of the present study was to evaluate the bioequivalence of two felodipine extended release (ER) tablets, Splendil (YuHan Corporation) and Stapin (Hana Pharmaceutial Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The felodipine release from the two felodipine formulations in vitro was tested using KP VIII Apparatus II method at pH 6.5 buffer solution. Twenty six healthy male subjects, $22.73{\pm}1.78$ years in age and $66.66{\pm}7.28\;kg$ in body weight, were divided into two groups and a radomized $2{\times}2$ cross-over study was employed. After two tablets containing 5 mg as felodipine were orally administered, blood sample was taken at predetermined time intervals and the concentrations of felodipine in serum were determined using column-switching HPLC method with UV detector. The dissolution profiles of two formulations were similar at pH 6.5 buffer solution. Besides, the 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 $T_{max}$. The results showed that the differences between two formulations based on the Splendil were 2.53%, 1.32% and 18.32% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance rage of log(0.86) to log(1.25) $(e.g.,\;log(0.86){\sim}log(1.20)\;and\;log(0.89){\sim}log(1.23)\;for\;AUC_t,\;C_{max},\;respectively)$. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Stapin ER tablet and Splendil ER tablet are bioequivalent.

• 한국멀티미디어학회논문지
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• 제15권4호
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• pp.425-438
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• 2012

본 논문에서는 컴퓨터 비전 기술 기반으로 사용자의 손 움직임과 가상객체 사이의 자연스러운 상호작용을 위한 증강현실 시스템을 제안한다. 기존의 증강현실 시스템은 마커를 이용하거나 트랙커 같은 센서를 직접 조작해야 했기 때문에 사용자에게 불편함을 제공한다. 우리는 이러한 문제점을 해결하기 위해서 손 움직임을 증강현실 시스템에 적용한다. 또한 가상객체의 움직임에 물리적 현상을 적용하여 현실감을 부여한다. 제안한 시스템은 마커를 이용하여 기하학적 정보를 얻어 가상의 공이 움직이는 가상공간, 벽돌 등의 시스템 환경을 구성하였으며, 사용자의 손 움직임은 테이핑을 통하여 특징점을 추출하여 정보를 얻는다. 이 특징점을 이용하여 손 위에 가상 평면을 안정적으로 정합한다. 가상의 공의 움직임은 포물선 방정식을 이용하여 기본적으로 포물선 움직임을 보이고, 평면 또는 벽돌에 충돌이 발생할 경우에는 가상 공의 위치와 평면의 법선벡터를 이용하여 가상 공의 움직임을 보였다. 실험을 통해 충돌 시 발생되는 잘못된 공의 위치에 대해 보정되는 과정을 보였고, 증강된 가상객체의 떨림과 수행속도에 대해 마커를 이용한 시스템과 비교하여 제안한 시스템으로 대체할 수 있다는 것을 확인하였다.

• 한국의학물리학회지:의학물리
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• 제21권1호
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• pp.99-112
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• 2010

국내에서 방사선치료를 위한 선형가속기 품질관리 프로토콜은 많이 개발되어 왔지만 선형가속기를 기반으로 하는 방사선수술장비의 품질관리 프로토콜 개발은 현재까지 거의 이루어져 있지 않고 있다. 이에 본 연구는 선형가속기 기반 일체형 방사선수술장비인 노발리스의 정확도 및 정밀도를 유지하기 위하여 일간, 주간, 월간, 연간에 주기적으로 시행하여야 하는 노발리스 품질관리 프로토콜을 개발 하고 품질관리 상태의 종합적 확인을 할 수 있는 해부학적 팬텀을 제작하였다. 이를 위하여 국내외의 선형가속기를 이용하는 방사선수술 품질관리 프로토콜의 수집 및 분석을 통해 필수적인 품질관리항목과 각 항목의 허용치를 정하였다. 노발리스 품질관리 항목은 기계적 정확도 부분과 방사선 전달 부분의 2가지로 분리하고 기계적 정확도 부분은 방사선발생 장치부, 보조장치부, 그리고 미세다엽 시준기부의 3가지 부분으로 방사선 전달부분은 치료 중심점 평가와 선량학적 평가의 2가지 부분으로 나누어 작성하였다. 최종적으로 노발리스 품질관리 유지를 위하여 시행하여야 하는 일간, 주간, 월간, 연간의 노발리스 품질관리 항목 표를 완성하였다. 완성된 노발리스 품질관리항목 표는 노발리스가 방사선수술에 적합한 정확도 및 정밀도를 유지하는데 필요한 지표로서 기여 할 수 있을 것이라 생각된다.

• 한국작물학회지
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• 제31권4호
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• pp.483-492
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• 1986

토양산도가 대두품종의 생육 및 수량과 근상착생에 미치는 영향을 구명하는 동시에 내산성의 품종간 차이를 추구하고자 황금콩외 15품종을 공시하여 토양산도를 pH 5, 6, 7의 3수준에서 실시한 시험결과를 요약하면 다음과 간다. 1. 경장 및 절수로 본 개화기의 생육정도는 대부분의 품종에서 토양 pH가 낮을수록 감소되었으나 장백콩, 장엽콩, 및 Williams등은 토양산도에 따른 차이를 인정할 수 없었다. 2. 개화기에 있어서의 근상착생정도는 단엽콩, 장백콩 및 동북태를 제외한 대부분의 품종에서 토양 pH가 낮을수록 적은 경향이었고 특히 pH5 수준에서 감소정도가 현저하였다. 3. 성숙기의 경장은 Williams, Clark 및 힐콩 등 장간종에서, 분지수는 외알콩, 장단백목, LC 7601, 봉의. 광교 및 황금콩 등에서, 개체당 협수 및 종실수는 봉의, 단엽콩 및 LC7601 등에서, 100입중은 장백중, 봉의, 외알콩, Clark 및 LC7601 등에서 각각 토양 pH가 낮을수록 감소되는 경향이었으나 장단백목, 외알콩 및 위산 등은 토양 pH가 낮은 경우에 경장이 오히려 다소 증대되는 경향이었다. 4. 수량은 품종, 토양산도 및 이들의 백호작용에 모두 고도의 유의성이 인정되었고 대체로 토양 pH가 낮을수록 감수되는 경향이었으나 장백콩은 토양산도에 따른 안정성이 가장 높았고 봉의 및 위산 등도 안정성이 높은 편이었으며 토양산도에 따른 안정성도 비교적 높으면서 다수성인 품종은 황금콩 및 LC 7852 등이었다. 5. 토양산도와 수량간에 유의적 상관을 나타낸 품종은 황금콩, 광교, Williams, 단엽콩, LC 7601, 함안 및 장단백목 등이었다. 6. 수량은 토양 pH 5 수준에서 분지수 및 개체당협수와 유의적 상관이 인정되었고 개체당 종자수와는 모든 pH수준에서. 그리고 100입중과는 pH 6 및 7수준에서 고도의 유의적 상관을 나타내었다. 7. 조단백함량은 품종과 토양산도 및 이들의 상호작용 등에 모두 고도의 유의성이 인정되었고 광교, Clark, LC7852, 함안 및 외알콩 등에서는 토양산도와 조단백함량간에 유의적 상관이 인정되었으나 장백콩, 장엽콩, 동북태, Williams 및 LC7601 등에서는 토양산도에 따르는 차이를 인정할 수 없었다.

• 대한두경부종양학회지
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• 제16권2호
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• pp.167-171
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• 2000

Objectives: To compare the outcomes of treatment with a focus on the effectiveness of the two primary techniques of radiation used for treating parotid gland malignancies. Materials and Methods: A retrospective analysis of 70 patients with parotid gland cancer treated between 1981-1997. Radiation was delivered through an ipsilateral field of high energy electron and photon in 37 patients(52.9%). Two wedge paired photon was used to treat in 33 patients(47.1%). The median dose was 60 Gy, typically delivered at 1.8-2.0Gy per fraction. The median follow-up times for surviving patients was 60 months. Results: The overall and disease free 5 year survival rates were 71.6% and 69.5%, respectively. Wedge paired photon and photon-electron treatment disease tree 5 year survival rates were 61.1% and 80.5%, respectively. Overall local failure rate was 18.6%. Local failure rate of wedge paired photon technique was higher than that of mixed beam technique. Late complication rate was 37.1%, but most of them were mild grade. Conclusion: Techniques of radiation were associated with local control. The technique of using an ipsilateral field encompassing the parotid bed and treated with high energy electrons often mixed photons was effective with minimal severe late toxicity. To irradiate deep sited tumors, we consider 3-D conformal treatment plan for well encompassing the target volume.

• Journal of Pharmaceutical Investigation
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• 제32권3호
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• pp.215-221
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• 2002

Cephradine is a first generation cephalosporin and has broad spectrum antibacterial activity against gram-positive and gram-negative microorganisms, through inhibition of bacterial cell wall synthesis. Cephradine is useful for treatment of infections of the urinary and respiratory tract, skin and soft tissues. The purpose of the present study was to evaluate the bioequivalence of two cephradine capsules, Cefradine Yuhan (YuHan Corporation) and Broadcef (Ilsung Pharmaceuticals Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cephradine release from the two cephradine capsules in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty normal male volunteers, $23.10{\pm}2.90$ years in age and $67.69{\pm}8.04\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 500 mg as cephradine was orally administered, blood was taken at predetermined time intervals and the concentrations of cephradine in serum were determined using HPLC method with UV detector. The dissolution profiles of two cephradine capsules were very similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AVC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AVC_t\;and\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences in $AVC_t,\;C_{max}\;and\;T_{max}$ between two capsules based on the Cefradine Yuhan were -2.87%, -0.96% and -4.85%, respectively. There were no sequence effects between two capsules in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of 1og(0.8) to log(1.25) $(e.g.,\;log(0.93){\sim}log(1.02)\;and\;log(0.88){\sim}log(1.13)\;for \;AVC_t\;and\;C_{max},\;respectively)$. The 90% confidence interval using untransformed data was within ${\pm}20%$ $(e.g., \;-17.54{\sim}7.78\;for\;T_{max})$. All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Broadcef capsule is bioequivalent to Cefradine Yuhan capsule.

• Journal of Pharmaceutical Investigation
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• 제33권2호
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• pp.135-140
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• 2003

Fluconazole is an orally active bis-triazole antifungal agent, which is used in the treatment of superficial and systemic candidiasis and in the treatment of cryptococcal infections in patients with the acquired immuno deficiency syndrome (AIDS). The purpose of the present study was to evaluate the bioequivalence of two fluconazole capsules, Diflucan (Pfizer Pharmaceuticals Korea Inc.) and Flucona (Korean Drug Pharmaceuticals Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The fluconazole release from the two fluconazole capsules in vitro was tested using KP VII Apparatus II method at 0.1 M hydrochloride dissolution media. Twenty normal male volunteers, $23.60{\pm}1.88$ years in age and $63.57{\pm}6.17\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three capsules containing 50 mg as fluconazole was orally administered, blood was taken at predetermined time intervals and the concentrations of fluconazole in serum were determined using HPLC method with UV detector. The dissolution profiles of two fluconazole capsules were very similar at 0.1 M hydrochloride dissolution media. Besides, the 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 $T_{max}$. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two capsules based on the Diflucan were 4.96%, 5.65% and -13.76%, respectively. There were no sequence effects between two capsules in these parameter. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) $(e.g.,\;log(1.01){\sim}log(1.08)\;and\;log(1.00){\sim}log(1.12)\;for\;AUC_t\;and\;C_{max},\;respectively)$, indicating that Flucona capsule is bioequivalent to Diflucan capsule.

• Journal of Pharmaceutical Investigation
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• 제32권2호
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• pp.135-140
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• 2002

Cefadroxil is a semi-synthetic cephalosporin active against many Gram-positive and Gram-negative bacteria. The drug has been used for the treatment of the urinary and respiratory tract infections when caused by susceptible strains of the designated microorganism. The purpose of the present study was to evaluate the bioequivalence of two cefadroxil capsules, Duricef (Bo Ryung Pharmaceutical Co. Ltd.) and Hanacef (Korean Pharmaceutical Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cefadroxil release from the two cefadroxil capsules in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four normal male volunteers, $21.58{\pm}2.43$ years in age and $70.74{\pm}10.29$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 500 mg as cefadroxil was orally administered, blood was taken at predetermined time intervals and the concentrations of cefadroxil in serum were determined using HPLC with UV detector. The dissolution profiles of two cefadroxil capsules were very similar at all dissolution media. The 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 $T_{max}$. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two capsules based on the Duricef were 0.05%, -5.29% and 4.53%. There were no sequence effects between two capsules in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) $(e.g.,\;log(0.95){\sim}log(1.05)\;and\;log(0.87){\sim}log(1.02)$ for $AUC_t\;and\;C_{max}$, respectively). The 90% confidence interval using untransformed data was within ${pm}20%$ $(e.g.,\;-6.75{\sim}15.74\;for\;T_{max})$. All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Hanacef capsule is bioequivalent to Duricef capsule.

• 대한방사선치료학회지
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• 제19권1호
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• pp.7-17
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• 2007

목 적: 최신 방사선 치료에서는 환자 치료계획 시 종양체적에 분포한 3차원 공간적 선량분포의 검증이 중요시 되고 있는 추세이다. 기존의 선량계로는 공간상의 선량분포를 알 수 없어 이러한 문제점을 극복하고자 조직등가 겔 내에서 방사선에 의해 변화된 화학적 변화를 자기공명영상을 이용하여 3차원적 선량 분석을 시행하는 겔 선량계를 개발하고자 하였다. 대상 및 방법: 겔 합성 시료의 조성비에 따른 정상산소 중합체 겔의 특성 연구를 위해 다섯 개 조합의 중합체 겔을 합성하였다. 이후 방사선량과 자기공명영상의 횡이완 시간과의 상관관계를 구하기 위해 겔로 채워진 후 밀봉된 선량측정용 바이알을 제작하였고, 방사선을 조사하였다. 그리고 방사선 조사 후 선량측정용 바이알의 자기공명영상을 획득하였다. 선량특성 평가 항목으로는 자기공명영상과 R2 지도, 조성비 별 선량-R2 반응곡선 및 선량분포 등의 인자를 분석, 평가하였다. 결 과: 각 조성비 별 정상산소 중합체 겔의 선량-R2 반응 곡선에서 set 1, 3, 4, 5 의 기울기는 각각 0.60, 0.775, 0.683, 0.954이며 절편은 각각 0.322, 0.473, 0.611, 1.032이었다. Set 3의 경우 선형성도 다른 조합보다 비교적 우수한 0.9491이며 선량 반응이 일어나는 문턱 값 또한 0.473으로 0.5 Gy 정도에서 반응이 일어나는 것을 확인할 수 있었다. 결 론: 본 연구에서는 임상에서 실용적으로 사용할 수 있는 정상산소 중합체 겔(normoxic gel)을 항산화제를 사용하여 정상산소 조건에서 합성하였고, 이상적인 조성비를 얻을 수 있었다.