A Collaborative Study to Establish the Second Korean National Reference Standard for Snake Venom |
Han, Kiwon
(Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety)
Jung, Kikyung (Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety) Oh, Hokyung (Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety) Song, Hojin (Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety) Park, Sangmi (Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety) Kim, Ji-Hye (Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety) Min, Garam (Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety) Lee, Byung-Hwa (Quality Control Team, Korea Vaccine Co., Ltd.) Nam, Hyun-sik (New Drug Development Center, Osong Medical Innovation Foundation) Kim, Yang Jin (Department of Statistics, Sookmyung Women's University College of Science) Ato, Manabu (Department of Immunology, National Institute of Infectious Diseases) Jeong, Jayoung (Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety) Ahn, Chiyoung (Advanced Therapy Products Research Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety) |
1 | Wuster, W., Golay, P. and Warrell, D. (1997) Synopsis of recent developments in venomous snake systematics. Toxicon, 35, 319-340. DOI |
2 | Lim, H., Kang, H.G. and Kim, K.H. (2013) Antivenom for snake bite in Korea. J. Korean Med. Assoc., 56, 1091-1103. DOI |
3 | Eble, J.A. (2010) Matrix biology meets toxinology. Matrix Biol., 29, 239-247. DOI |
4 | Omori, T., Iwanaga, S. and Suzuki, T. (1964) The relationship between the hemorrhagic and lethal of Japanese mamushi (Agkistrodon halys blomhoffi) venom. Toxicon, 2, 1-4. DOI |
5 | Korea Food and Drug Administration (1993) Minimum Requirement for Biological Products (in Korean). |
6 | Fukuda, T., Iwaki, M., Hong, S.H., Oh, H.J., Wei, Z., Moro- kuma, K., Ohkuma, K., Dianliang, L., Arakawa, Y. and Takahashi M. (2006) Standardization of regional reference for mamushi (Gloydius blomhoffii) antivenom in Japan, Korea, and China. Jpn. J. Infect. Dis., 59, 20-24. |
7 | Yoo, S.H., Lee, N.K., Kim, S.N., Hong, C.M., Lee, K.H., Shin, I.S., Lim, J.H., Kim, Y.L., Ahn, M.J. and Park, S. (2004) Establishment of venom standard for potency test of Agkistrodon antivenom. The Annual Report of KFDA, 8-1, 1031-1036. |
8 | Oh, H., Shin, J., Ato, M., Ma, X., Williams, D., Han, K., Kim, Y.J., Kang, H.G., Jung, K., Hanada, K., Ochiai, M., Hung, P.V., Park, S. and Ahn, C. (2017) The First Meeting of the National Control Laboratories for Vaccines and Biologicals in the Western Pacific in 2016. Osong Public Health Res. Perspect., 8, 91-103. DOI |
9 | Reed, L.J. and Muench, H. (1938) A simple method of estimating fifty percent endpoints. Am. J. Epidemiol., 27, 493-497. DOI |
10 | Kondo, H., Kondo, S., Sadahiro, S., Yamauchi, K. and Murata, R. (1971) Standardazation of trimeresurus flavoviridis (Habu) antivenin. J. Med. Sci. Biol., 24, 323-327. DOI |
11 | World Health Organization (2010) WHO guidelines for the production control and regulation of snake antivenom immunoglobulins. World Health Organization, Geneva. [cited 2017 Jan 1]. Available from: http://www.who.int/bloodproducts/snake_antivenoms/snakeantivenomguide/en/. |
12 | Lee, N., Seo, J.S., Kim, J.O. and Ban, S.J. (2017) Establishment of the 2nd Korean national biological reference standard for blood coagulation factor VIII:C concentrate. Biologicals, 47, 59-63. DOI |
13 | ICH (1995) Quality of biotechnological products: stability testing of biotechnological/products: stability testing of biotechnological/biological products. Q5C in International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. |