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KMID : 0379520010170040297
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한국독성학회지
2001 Volume.17 No. 4 p.297 ~ p.301
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Single Dose Toxicity Studies of C.1-50005 (Hepatitis A virus Vaccine) in Rats and Dogs
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Kim Jong-Ho
Lee Sung-Hak
Choi Jae-Mook
Kim Dal-Hyun
Kim Hyun-Seok
Chung Yong-Ju
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Abstract
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The acute toxicity of CJ-50005, an inactivated whole virus vaccine derived from hepatitis A virus (HM175) grown in human MRC-5 diploid fibroblast culture, was tested in Sprague Dawley (SD) rats and beagle dogs. CJ-50005 was orally and intramuscularly administered up to the maximum dose of 81mutextrm{g}/kg. as much as 3,000 times of the expected clinical dose, in SD rats and was intramuscularly administered up to 27 mutextrm{g}/kg, as much as 1,000 times of the expected clinical dose, in beagle dogs. In these experiments, there were no death and clinical changes which were related to CJ-50005 administration. In addition, there were no significant changes between control and treated groups in body weights and autopsy findings. In conclusion, the administration of CJ-50005 over 81mutextrm{g}/kg in SD rats and over 27mutextrm{g}/kg in beagle dogs was proved to be safe, and it is thought that CJ-50005 may not show any toxicity in its clinical use.
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KEYWORD
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Acute toxicity, Hepatitis A vaccine, CJ-50005, Rat, Dog
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