• The Korean Journal of Applied Statistics
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• v.29 no.2
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• pp.279-289
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• 2016

Bioequivalence trials based on higher order crossover designs have recently been conducted for highly variable drugs since the Ministry of Korea Food and Drug Safety (MFDS) added new regulations in 2013 to widen bioequivalence limits for highly variable drugs. However, a statistical discussion of higher order crossover designs have not been discussed yet. This research proposes the statistical inference of bioequivalence based on $3{\times}3$ crossover design and discusses it with the MFDS regulations. An illustrated example is also given.

• 한국생물공학회:학술대회논문집
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• 2003.04a
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• pp.662-662
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• 2003

• Proceedings of the Korean Society of Applied Pharmacology
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• 1994.04a
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• pp.346-346
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• 1994

1. 위장관통과 실험결과 polycarbphil 흑은 carbomer로 코팅한 생체막점착성 마이크로캅셀 모두가 Eudragit RS/RL 마이크로캅셀보다 위 및 소장상부에 다량 존재하는 것으로 보아 Polymer의 생체막점착성에 의해 제제의 위내용배출이 억제되었음을 알 수 있었다. 2. Polycarbophil 흑은 carbomer로 코팅한 생체점착성 마이크로캅셀의 AUC는 Eudragit RS/RL 마이크로캅셀의 결과에 비해 현저히 증가되었다. Polycarbophil로 코팅한 생체막점착성 마이크로캅셀은 carbomer로 코팅한 제제에 비해 Cm의 증가뿐아니라 전체적인 약물흡수의 증가와 높은 혈중농도의 지속을 보여주어 생체막점착성 제제의 이상적인 약물흡수패턴을 보여주었다. 3. 흡수속도효율 (ARE)면에서 생체막점착성 마이크로캅셀이 코팅전의 마이크로캅셀에 비해 약간 떨어졌으나, polycarbophil 코팅제제의 경우 전체적인 흡수양상이 마이크로캅셀에 비해 우수하고 또한 제어방출효율 (CRE)이 현저하게 증가되어 생체막점착성 제제로서의 유용성을 확인할 수 있었다. 4. 위내용배출의 지연효과, AUC, CRE 등을 종합해 볼때, Polycarbophil 로 코팅한 생체막점착성 마이크로캅셀은 투여횟수의 감소 및 생체이용율을 향상시키는 유용한 제제로 평가되었다.

• The Korean Journal of Applied Statistics
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• v.26 no.4
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• pp.675-686
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• 2013

The Korea Food and Drug Administration(KFDA) recommends the use of a $2{\times}2$ crossover design to assess the bioequivalence of generic drugs. However, a standard $2{\times}2$ crossover design for bioequivalence trials is often considered problematic due to ethical and economic issues as highly variable drugs are usually required by large numbers of subjects when designing the trial. To overcome this problem a $2{\times}4$ crossover design has been a recommended option as per US regulations; in addition, a $2{\times}3$ crossover design has also recently drawn special attention as an efficient alternative. The current KFDA regulation requires an ANOVA table for every bioequivalence study; however, ANOVA tables of $2{\times}4$ and $2{\times}3$ crossover designs have never been published in the literature. This study shows the derivation of tables of analysis of variance for a $2{\times}4$ cross-over design and a $2{\times}3$ cross-over design. We also suggest a sample size formulas for $2{\times}2$, $2{\times}4$ and $2{\times}3$ crossover designs to provide information on the selection of efficient designs for highly variable drugs.

• Journal of Bio-Environment Control
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• v.21 no.2
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• pp.134-139
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• 2012

Inhibition effects on spore germination and mycelia growth for gray mold (Botrytis cinerea) were investigated in vitro using environment-friendly agricultural materials as well as environment-friendly pesticides. The inhibition effect on mycelia growth of gray mold is the highest when the gray mold mycelia were treated with a pesticide (commercial name: Koreayeok, Jihabudea KM, Sootingtan, Sootingstar) that contains a mixture of Bacillus subtilis, resulting in 100% inhibition of the mycelia growth. Meanwhile, the range of less than 20% inhibition effects on the growth of gray mold mycelia was observed with other commercial agricultural materials. The significant inhibition effects on spore germination of gray mold fungus were shown in vitro with two water dispersible pesticides containing sulfur [BTB (97.7%) and SulfurStar (92.3%)], respectively. These in vitro results of inhibiting of the spore germination and mycelia growth together cannot found. It remains to be determined whether the selected environment-friendly agricultural materials in effective control of gray mold in vitro can be used to control gray mold in field.

• Procedding of Korea Feed Ingredients Association Conference
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• v.1
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• pp.119-135
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• 2000

• 대한임상약리학회:학술대회논문집
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• 2000.04a
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• pp.11-12
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• 2000

• 동물약계
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• no.26
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• pp.2-4
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• 1995

[ $\cdot$ ]생물학적제제 국가검정품 및 보관품 발췌기준

• Korean Journal of Pharmacognosy
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• v.4 no.2
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• pp.53-58
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• 1973

• Proceedings of the Zoological Society Korea Conference
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• 1996.10a
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• pp.98.1-98
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• 1996