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왕소영(So-Young Wang),최환수(Whan-Soo Choi),김용진(Yong-Jin Kim) 한국의사학회 2003 한국의사학회지 Vol.16 No.1
The GyoJungEuiSeoGook(校定醫書局, the bureau for revising of medical books) which was established in the 2nd year of InJong GaWoou of Song dynasty, made comparative analyzation about various kinds of publication and reference materials of all classical medical books that was published until Jin Han and Su Dang dynasty, revised the medical books like as Bozushinnongboncho(補注神農本草), Zungkwangbozuhwangjenegyungsomun(重廣補注黃帝內經素問), Shanghanlon(傷寒論), Bigupchunggumyobang (備急千金要方), Magkyung(脈經), Oedaebiyo(外臺備要), Hwangjechimgugapeulgyung(黃帝鍼灸甲乙經), Cchunggumikbang(千金翼方) etc. The signification of such revision was not only to preserve the materials which may be lost before, bibliographically and also make the books of Hwangjenegyung(黃帝內經), Shanghanlon(傷寒論) etc. become more regularly. And it made the foundation of Korean Medical research depends on the documentary records so as to make it have big development by deductive method till the beginning of modern age. The success of GyoJungEuiSeoGook(校定醫書局) indicates that the stagnation of Korean Medical research due to it’s behind with the development of politics-economy, social culture and scientific technology which based on western scientific culture. So we may draw the conclusion that the success of scientific research needs to parallel with the external and internal factors of the surrounding science.
김용진,왕소영 한국의사학회 2000 한국의사학회지 Vol.13 No.1
Through this research, it was discovered that Wang Sa-wung studied classics such as 『Nai Kyung』, and brought about new theries and prescription by combining it with his own experience. He asserted ‘Ki Hwa Chu Ki' theory which differentiated 'Shin Kam' and 'Bok Sa' within 'On Byung', and this was a new theory which was not in existence before. The main reason for the recognition received by the future generation is, not only because of the substantial theoretical background but, due to the fact that his ideas were based on making practical use easier within rich near a bed experience.
박인숙,김동섭,최기환,왕소영,임화경,오우용,김소희,강주희,방영주,김주일,Park, In-Sook,Kim, Dong-Seop,Choi, Ki-Hwan,Wang, So-Young,Lim, Hwa-Kyung,Oh, Woo-Young,Kim, So-Hee,Kang, Ju-Hee,Bang, Yung-Jue,Kim, Joo-Il 대한임상약리학회 2002 臨床藥理學會誌 Vol.10 No.2
The enormous cost, intensive time, and constant efforts are required the drug discovery and development of bringing new drug products to the marketplace. The past several years, KFDA approved new drugs developed by local pharmaceutical industries; that is Sunppla, Factive etc. In addition to, investigational new drug application (IND) was established to accelerate new drug development and harmonize with international standards in 2002. At this point of time it is urgent problem to develop ability of reviewing new drug applications (NDAs) scientifically and appropriately to ensure that new drugs are safe and effective. There are many scientific issues embedded in new drug approval process from non-clinical studies to phase 3 clinical trials; 1) sample size, 2) application of end point, 3) statistical method, and etc. However the overall relation between protocols/reports of clinical trials and the characteristics of domestic medical system has fully not been studied. There is also, no references or data for the point to be considered in drug approval process. On this background, the objectives of this study are introduction of guidelines for the requirement for approval or evaluation of safety/efficacy in other countries and presentation how to practice clinical trial for new oncologic products in the present situation of clinical trial. We hope that the guidelines contribute to providing methods of clinical trials and procedures, and evaluating method to develop chemotherapeutic agents.
최기환,박인숙,임화경,오우용,왕소영,김소희,김주일,김동섭 대한약학회 2003 약학회지 Vol.47 No.2
The present paper reviews the notion and comparison of the Korea Food and Drug Administration(KFDA) general pharmacology and the International Conference on Harmonisation (ICH) safety pharmacology. General pharmacology or safety pharmacology is termed the study to determine the potential of a compound to induce adverse pharmacological effects. KFDA general pharmacology studies have been considered an important component in drug safety assessment and these were originally referred to those designed to examine effects other than the primary therapeutics effect of a drug candidate. The KFDA notified the Guideline for General Pharmacology in 1997. Safety pharmacology studies were focused on identifying adverse effects on physiological functions. In the ICH came into place S7A Safety Pharmacology Studies for Human Pharmaceuticals in 2001. A new chemical entity should be assessed for its side effects, initially in those physiological systems which are generally agreed to be the key systems that are essential for life; these "core system" include the central nervous system, cardiovascular system and respiratory system in safety pharmacology studies. These studies should be performed in compliance with Good Laboratory Practice (GLP).