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오우용(Woo Young Oh),이상호(Sang Ho Lee),김형진(Hyung Jin Kim),주상섭(Sang Sup Jew),박형근(Hyeung Geun Park),함광수(Kwang Su Ham),조장섭(Jang Sup Cho),이선미(Sun Mee Lee) 한국응용약물학회 2001 Biomolecules & Therapeutics(구 응용약물학회지) Vol.9 No.3
N/A The single oral toxicity of JG-381 was studied in Sprague-Dawley rats of both sexes. In this study, rats were administrated orally with dosages of 267, 400, 600, 900 and 1350 ㎎/㎏ of JG-381. We daily examined number of deaths, clinical signs, body weights and gross findings for 14 days after JG-381 administration. When we administered different doses of 267, 400, 600, 900 and 1350 ㎎/㎏, we found 1, 4, 4, 5 and 5 male rats died and 3, 5, 4, 5 and 5 female rats died within 1 day after administration, respectively. Some clinical signs (decrease locomotor activity, salivation, soft stool, prone position, lacrimation, crouching position, convulsion, ataxic gait, incontinence of urine) were also observed during the experimental period. Our findings suggest that oral LD_(50s) (95% confidence limit) for male and female rats are 327 ㎎/㎏ (270∼396 ㎎/㎏) and 250 ㎎/㎏ (236∼264 ㎎/㎏), respectively.
SD 랫드에서 ( R ) - JG - 381 의 단회경구독성시험
오우용(Woo Young Oh),주상섭(Sang Sup Jew),함광수(Kwang Su Ham),이상호(Sang Ho Lee),김종춘(Jong Chun Kim),박형근(Hyeung Geun Park),조장섭(Jang Sup Cho),이선미(Sun Mee Lee) 한국응용약물학회 2002 Biomolecules & Therapeutics(구 응용약물학회지) Vol.10 No.1
N/A A single administration toxicity of (R)-JG-381 was studied in Sprague-Dawley rats of both sexes. In this study, rats were administered orally with dose of 50, 100, 200, 400 and 800 ㎎/㎏ of (R)-JG-381. We daily examined number of deaths, clinical signs, body weights and gross findings for 14 days after (R)-JG-381 administration. When we administered different doses of 100, 200, 400 and 800 ㎎/㎏, we found 5, 3, 5 and 5 male rats and 1, 4, 4 and 5 female rats dead within 1 day after administration, respectively. Some clinical signs(decrease of locomotor activity, decreased respiration rate, lacrimation, prone position) were observed during the experimental period. Our findings suggest that oral LD_50s(95% confidence limit) for male and female rats are 93.8 ㎎/㎏ (28.8∼161.6 ㎎/㎏) and 166.3 ㎎/㎏ (89.1∼284.8 ㎎/㎏), respectively.
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.
Nalbuphie의 병용투여에 의한 morphine의 내성 및 의존성 헝성 저하효과
정면우(Myeon Won Chung),임화경(Hwa Kyung Lim),전용준(Yong Joon Jeon),김혜정(Hye Jung Kim),박인숙(In Sook Park),오우용(Woo Yong Oh),왕소영(So Young Wang),박윤주(Yoonju Park),강주희(Ju Hee Kang),김동섭(Dong Sup Kim),김주일(Joo Il Kim) 대한약학회 2002 약학회지 Vol.46 No.4
Morphine has been used widely on the treatment of many types of chronic pain. However the development of tolerance to morphine by repeat application is a major problem in pain therapy: The purpose of the present study was to investigate whether combined administration of nalbuphine with morphine affects the development of tolerance to and dependence on morphine. We hypothesize that the use of nalbuphine, k-agonist may prove to be useful adjunct therapy to prevent morphine-induced undesirable effects in the management of some forms of chronic pain. Morphine (10 mg/kg) was injected to rats intraperitoneally for 5 days. The variable dose of nalbuphine (0.1,1.0 and 5.0 mg/kg) was administered (I.p.) in combination with morphine injection. The development of tolerance to morphine was assessed by measuring the antinociceptive effect with the Randall-Selitto apparatus. The development of dependence on morphine was determined by the scoring the precipitated withdrawal signs for 20 min after injection of naloxone (10 mg/kg,I.p.). Nalbuphine did not attenuate antinociceptive effect of mofhine in rats. Interesting1y; combined administration of morphine with nalbuphine (100:1) sign- nifcantly attenuated the development of morphine tolerance and dependence. These results suggest that the co-admin-istration of nalbuphine with morphine in chronic morphine treatment can be one of therapies to reduce the development of dependence on morphine.