Table 3.
Test | 1 TD of Lethal titer (μg)¶ | 1 TD of Hemorrhagic titer (μg)¶ | |||||||
---|---|---|---|---|---|---|---|---|---|
| |||||||||
1* | 2† | 3‡ | 4§ | 5|| | 1* | 2† | 3‡ | 4§ | |
1 | 94.20 | 103.77 | 94.20 | 107.92 | 85.86 | 8.50 | 12.18 | 11.28 | 11.08 |
2 | 78.58 | 94.20 | 94.20 | 107.92 | 102.65 | 8.87 | 10.99 | 11.44 | 8.99 |
3 | 86.37 | 86.37 | 96.00 | 107.92 | 96.00 | 10.13 | 10.48 | 11.33 | 9.14 |
4 | 68.37 | 94.20 | 96.00 | 86.37 | 89.78 | 8.67 | 10.81 | 11.26 | 9.69 |
5 | 78.58 | 78.58 | 94.20 | 86.37 | 89.78 | 9.41 | 10.70 | 10.78 | 10.11 |
6 | 94.20 | 94.35 | 86.37 | 10.87 | 12.23 | 11.40 | |||
7 | 86.37 | 94.20 | 86.37 | 11.36 | 11.19 | 11.84 | |||
8 | 94.20 | 96.00 | 86.37 | 11.19 | 10.89 | 11.81 | |||
9 | 98.23 | 86.37 | 94.20 | 10.22 | 10.65 | 9.73 | |||
10 | 96.00 | 78.58 | 94.20 | 10.94 | 11.38 | 11.38 | |||
Common potency (%) | 87.51 | 90.66 | 92.21 | 99.30 | 92.81 | 10.02 | 11.15 | 11.23 | 9.80 |
95% confidence interval | 81.49 | 85.69 | 89.67 | 88.95 | 87.04 | 9.34 | 10.77 | 10.85 | 9.06 |
~93.53 | ~95.64 | ~94.75 | ~109.65 | ~98.59 | ~10.69 | ~11.53 | ~11.60 | ~10.54 | |
Coefficients of variation | 11.10 | 8.86 | 4.44 | 11.89 | 7.10 | 10.84 | 5.51 | 5.37 | 8.59 |
General common potency | 90.13 | - | - | 10.80 | - |
National Institute of Food and Drug Safety Evaluation (NIFDS), Cheongju, Korea.
Osong Medical Innovation Foundation (KBIO), Cheongju, Korea.
Koreavaccine co., Ansan, Korea.
National Institute of Infectious Diseases (NIID), Tokyo, Japan.
National Quality Control Laboratory of Drug and Food (NQCLDF), Central Jakarta, Indonesia.
Titers are expressed as μg per animal. Standardization of NRS for Snake Venom in Korea 195