• 한국임상약학회지
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• 제16권1호
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• pp.34-39
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• 2006

Fexofenadine, one of selective histamine $H_1$ receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 120 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration(KFDA). The test product was Hanmi Fexofenadine Hydrochloride Tablet $120mg^{(R)}$ made by Hanmi Pharm. Co. and the reference product was Allegra Tablet $120mg^{(R)}$ made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a $2{\times}2$ cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t\;and\;C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t\;and\;C_{max}$ were log $0.844{\sim}log$ 1.149 and log $0.833{\sim}log$ 1.109, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet 120 mg is bioequivalent to Allegra Tablet 120 mg.

• Journal of Pharmaceutical Investigation
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• 제36권1호
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• pp.53-58
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• 2006

Fexofenadine, one of selective histamine $H_1$ receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 180 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Hanmi Fexofenadine Hydrochloride $Tablet^{\circledR}$ made by Hanmi Pharm. Co. and the reference product was Allegra $Tablet^{\circledR}$ made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a $2\;{\time}\;2$ cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t$ and $C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t$ and $C_{max}$ were $log\;0.822{\sim}log \;1.142$ and $log\;0.848{\sim}log\;1.172$, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet is bioequivalent to Allegra Tablet.

• 품질경영학회지
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• 제49권1호
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• pp.31-45
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• 2021

Purpose: A noncentral composite design method is to be developed to explore farther region for the first factorial design. A general guideline for sequential experimentation is provided. Methods: (1) A non-overlapping noncentral composite design (NNCD) is developed, in which the second factorial design shares one design point that indicates the best response value in the first factorial design. (2) Four composite designs are compared in terms of the four design evaluation criteria, which are D-, A, G, and I-optimality. (3) A follow-up design strategy is suggested based on the interaction effect, direction of improvement, number of factors. Results: (1) NNCD and model building method are presented, which is useful for exploring farther region from first factorial design block. (2) The performances of the four composite designs are compared. (3) A follow-up design strategy is suggested. Conclusion: (1) NNCD will be useful to explore farther region for the first factorial design. (2) A follow-up design strategy can be beneficial to the experimental practitioners for product and process design and improvement.

• Journal of Pharmaceutical Investigation
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• 제34권6호
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• pp.499-504
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• 2004

Paroxetine, a potent and selective serotonine reuptake inhibitor, has been used for the treatment of depression, obsessive-compulsive disorder, panic disorder and social phobia. The bioequivalence of two paroxetine preparations was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Samchully Paroxetine $tablet^{\circledR}$ made by Samchully Pharm. Co. and the reference product was Seroxat $tablet^{\circledR}$ made by GlaxoSmithKline. Twenty healthy male subjects, $22.4{\pm}2.6$ years old and $63.8{\pm}4.2\;kg$, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 20 mg paroxetine was orally administered, blood was taken at predetermined time intervals and the concentration of paroxetine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t$ and $C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t$ and $C_{max}$ were log 0.84-log 1.16 and log 0.85-log 1.14, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Samchully Paroxetine tablet is bioequivalent to Seroxat tablet.

• 한국식품과학회지
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• 제53권1호
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• pp.72-77
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• 2021

숙취를 해결하기 위해서는 숙취를 직접적으로 유발하는 물질인 아세트알데하이드의 조절이 가장 중요한 인자로 작용한다. 숙잠을 함유하는 복합물인 시험식품(CKDHC)의 섭취로 혈중 아세트알데하이드 농도가 대조식품 대비 통계적으로 유의하게 감소하여 숙취개선 효능을 확인하였다. 특히, 30분부터 각 시간별(mg/L), 혈중 아세트알데하이드 농도-시간곡선하 면적(AUC), 최고 혈중 아세트알데하이드 농도(Cmax)의 감소를 통해 30분부터 빠른 숙취개선 효능을 확인하였다. 본 연구의 주원료로 사용된 숙잠은 Ji 등(2016a)에 따르면 18종의 아미노산 및 무기질을 모두 함유하며, 고단백 식용곤충으로 간에 좋은 주요 아미노산인 Alanine, Arginine 등을 많이 함유하여 간의 효소활성에 긍정적인 영향을 줄 수 있음을 알수있다. 본 연구결과를 통해 숙잠을 함유하는 시험식품이 숙취해소제로 작용할 수 있으며, 특히 음주 전 섭취시 아세트알데하이드를 빠르게 분해하여 30분부터 숙취 개선에 효과가 있음을 입증하였다.

• 한국초지조사료학회지
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• 제38권3호
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• pp.156-164
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• 2018

Pesticide application in agriculture provides significant benefits such as protection from disease, prevention of harmful insects, and increased crop yields. However, accurate toxicological tests and risk assessments are necessary because of many related adverse effects associated with pesticide use. In this review, we discuss and analyze residual pesticides contained in livestock feed in Korea. A pesticide residue tolerance standard for livestock feed has not been precisely established; so, risk assessments are required to ensure safety. Standards and approaches for animal criteria and appropriate methods for evaluating residual pesticides are discussed and analyzed based on technology related to animal product safety in Korea. The safety of livestock feed containing pesticides is assessed to establish maximum residue limits relative to pesticides. Analysis of residual pesticides in milk, muscle, brain, and fat was performed with a livestock residue test and safety evaluation of the detected pesticide was performed. Efficacy of organic solvent extraction and clean-up of feed was verified, and suitability of the instrument was examined to establish if they are effective, rapid, and safe. This review discussed extensively how pesticide residue tolerance in livestock feed and hazard evaluation may be applied in future studies.

• 한국산업보건학회지
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• 제6권1호
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• pp.109-124
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• 1996

This study was performed to evaluate the performance of three passive samplers made in U.S.A. Three passive samplers selected for this study included products made by 3M, Gilian, and SKC in U.S.A. Three organic solvents, such as toluene, trichloroethylene, and n-hexane which are used frequently in Korean industry were selected for the study. Conclusions obtained from this study are summarized as follows. 1. For toluene and trichloroethylene, the overall accuracy of the results from all of three products was within 25 %, which is the criteria recommended by the U.S. National Institute for Occupational Safety and Health (NIOSH). For n-hexane, the overall accuracy of the results from two products except 3M was exceeding 25 %. Thus 3M product showed the best accuracy among three products. 2. When passive samplers collected organic vapors were exposed to clean air for two hours, there were 12 - 16 % loss of organic vapors due to reverse diffusion in Gilian products. There was no significant loss in results from other two products. 3. Air velocity affected greatly on the performance of passive samplers which did not have permeation membrane. At high velocity, 100 cm/sec, accuracies of results from Gilian and SKC were 57 - 108 and 128 - 164 %, respectively. However, the results from 3M samplers, which contain permeation membrane, indicated accuracy below 25 %. 4. When passive samplers collected organic vapors for eight hours, the accuracy was reduced. Thus, it is recommended that passive samplers be used for less than four hours.

• Korean Chemical Engineering Research
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• 제49권5호
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• pp.639-643
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• 2011

저등급석탄의 고품위화 기술 중 하나인 유중 슬러리 건조 공정은 슬러리 혼합, 슬러리 탈수, 유분 회수, 건조, 성형공정으로 구성된 건조 및 안정화 공정이다. 연간 백만 톤 규모의 저등급석탄 고품위화 공정에 대한 경제성을 분석하기 위하여 재료비, 노무비, 경비, 판매관리비를 산정하고 이에 따른 현금흐름을 계산하였다. 투자비 $1억, 할인율 12%, 내용 연수 20년에 대한 IRR, B/C ratio, NPV, 할인투자회수기간을 통해 사업의 경제성을 분석한 결과 모든 투자 기준을 만족하는 것으로 나타났다. 민감도 분석을 통해 투자가치가 원료탄과 제품 가격에 매우 민감한 것을 확인하였으며, 석탄가격이 급등하는 현 추세에서는 예상 투자가치가 증가할 것으로 판단되었다.

• 디지털융복합연구
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• 제17권8호
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• pp.221-228
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• 2019

클라우드 컴퓨팅 활성화 정책에 따라 가상화 제품에 대한 보안 중요성이 증가하였으며, 보다 안전한 클라우드 환경을 운영하기 위해서는 가상화 제품에 대한 사이버 보안위협 분석 및 보안요구사항 개발이 필요하다. 본 논문은 가상화 제품에 대한 보안특징 및 사이버 보안위협 분석을 통해 보안기능 요구사항 개발을 위한 사전 연구 목적으로 수행되었다. 이를 위해, 미국 및 영국에서 가상화 제품의 보안성 평가를 위해 사용하고 있는 평가제도와 가상화 제품에 대한 보안위협, 보안목적 및 보안요구사항들을 비교했다. 또한, 가상화 제품의 보안특징과 관련된 핵심적인 보안기능 요구사항 개발을 위한 항목 및 절차를 제안하여 보다 안전한 가상화 제품 개발 및 보안 평가기준 마련에 기여하고자 한다.

• 정보보호학회논문지
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• 제25권6호
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• pp.1549-1560
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• 2015

최근 몇 년간 크고 작은 개인정보 유출 사고가 끊이지 않고 있다. 그에 따라 개인정보보호 관련 법령이 지속적으로 제 개정 되고 있으며, 정보보호 제품도 발전하고 있다. 또한 보안 적합성 검증인 CC인증, 국정원 검증 암호모듈(KCMVP)등 정보보호 제품에 대한 인증체계도 엄격히 이뤄지고 있다. 본 논문에서는 개인정보보호 관련 법령인 개인정보보호법, 정보통신망 이용촉진 및 정보보호 등에 관한 법률, 위치정보의 보호 및 이용 등에 관한 법률과 신용정보의 이용 및 보호에 관한 법률, 전자금융거래법의 5개 법령의 물리적, 기술적, 관리적 보호조치 중 기술적 보호조치의 키워드를 분석 및 분류하였다. 그리고 법령상 기술적 보호조치와 CC인증 및 KCMVP 제품군과 지식정보보안산업협회(KISIA) 회원사의 정보보호 제품 분포와의 연관성을 분석하였다.