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국소 피부용 부신피질 스테로이드제제의 생물학적동등성시험 가이던스 : Topical Dermatologic Corticosteroids In Vivo Bioequivalence
정성희,최선옥,엄소영,정서정,김주일,정수연 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.6
After new medical system of separation of dispensary from medical practice was started in 2000 in Korea, to expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drugs are hot issues in Korea. It will be obligatory to submit bioequivalence reports for getting licenses of all generic prescription drugs in the near future. Like other countries such as US and Japan, the KFDA also has a plan to re-evaluate the already approved drugs by bioequivalence studies. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products among already approved drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. The information on Japanese guidance and the guidance's Q&As is already provided in our previous paper. In this paper. we examined the US guideline published in 1995 and compared with the Japanese guideline. which will give a useful information to make a guidance on bioequivalence studies of topical drug products in Korea.
최선옥,정성희,엄소영,정서정,김주일,정수연 한국약제학회 2005 Journal of Pharmaceutical Investigation Vol.35 No.1
Numerous drugs are chiral because they possess one or more chiral centers. Enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. However, the significance of stereochemistry of drugs in their therapeutic uses has received relatively little attention until recently. The US FDA issued a guideline on stereoisomeric drugs in 1992, and the European agency describes tests for new drug substances which are optically active in an ICH(International Conference of Harmonization) guideline. According to the guidance, enantiomers may differ in their pharmacokinetic. pharmacological and toxicological properties. Therefore, in this paper, we examined the recently published Canadian guidance, stereochemical issues in chiral drug development, which will be references to make a guidance on stereochemical issues in chiral drug development in Korea.
생체이용률에 미치는 음식물의 영향 및 식후 생물학적 동등성시험
최선옥,정성희,엄소영,정서정,김주일,정수연 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.3
A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to the drug products which are proven to be bioequivalent to the reference listed drugs. To expand the list of bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are the hot issues in Korea. Also, the KFDA has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drug products should be submitted to the KFDA for drug approval after July in 2004. Therefore, it is increasing the necessity to develop the bioequivalence-demonstrating methods for specific drug substances and preparations which require to conduct food-effect bioavailability or bioequivalence study. There are some differences between US and Japanese guidances of food-effect bioavailability and bioequivalence studies. In this paper, we examined the recently published US guidance about food-effect study and it will be a reference to make our own guidance about food-effect bioavailability and bioequivalence guidances in Korea.
국소용 후발의약품의 생물학적동등성시험을 위한 가이드라인
최선옥,정성희,엄소영,정서정,김주일,정수연 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.4
A new medical system of separation of dispensary from medical practice was started in 2000 in Korea. To expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are hot issues in Korea. The KFDA also has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drugs should be submitted to the KFDA in the application for drug approval. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. In this paper, we examined the recently published Japanese guideline, Guideline for Bioequivalence Studies of Generic Products For Topical Uses, and Q&A of the guideline, which will be references to make a guidance on bioequivalence studies of topical drug products in Korea.
생체이용률에 미치는 음식물의 영향 및 식후 생물학적동등성시험
최선옥,권광일,정성희,엄소영,정서정,김주일,정수연,김옥희 한국임상약학회 2005 한국임상약학회지 Vol.15 No.2
A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies.
콘크리트 보강재 CFRP 그리드 성형 공정에 따른 기계적 물성 평가
김지현,송범근,민경재,최정철,은화성,정서정 한국기계기술학회 2022 한국기계기술학회지 Vol.24 No.6
In this paper, the mechanical properties of glass fiber reinforced plastic (GFRP) rebar, which has been applied as an concrete reinforcement, and produced carbon fiber reinforced plastic (CFRP) grid were compared to develop a concrete reinforcement material with excellent mechanical properties. In addition, the mechanical properties of CFRP prepared with each molding process were evaluated. Three molding processes were evaluated: prepreg oven bagging, reaction injection molding (RIM), and pultrusion. The tensile strength of the CFRP grid prepared through pultrusion was 2.85GPa, the elastic modulus was 169.81GPa, and the strain was 1.68%, which was 2.85 times better in tensile strength, and 2.83 times better in elastic modulus compared mechanical properties of GFRP rebar. The strain was confirmed to be equivalent to GFRP rebar.