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최선옥,한윤옥,Choi, Sun-Ok,Han, Yoon-Ok 한국비블리아학회 2006 한국비블리아학회지 Vol.17 No.1
The bibliotherapy program was carried out in the 'S' elementary school in Kyonggi province. Korea for the fourth grader children in order to measure the grade of stresses which they experience and coping styles. and to find what kind of changes in terms of the grade of stress and coping styles over stress through the bibliotherapy program. Especially, it was going to understand elementary school children's stresses and coping styles, and verify effects of the bibliotherapy program as a device of helping amicable adoption for the various stress which they experience, and they come to experience.
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.
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.