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Historical control data
| Historical control values of micro nucleated polychromatic erythrocytes (MNPCE) | ||||||||
| Group | Hours after dosing (hr) | Dose (mg/kg) | N | MNPCE/PCE (%) (Mean±S.D.) |
Range [MNPCE/PCE] (%) | 95% control limit3) [MNPCE/PCE] | ||
| MIN | MAX | |||||||
| Negative control | 24 | 0 | 7 | 0.04±0.02 | 0 | 0.084 |
<13 | |
| Positive control | 24 | 20 | 5 | 4.18±1.26 | 3.530 |
4.835 |
- | |
| Historical control values of ratio of polychromatic erythrocytes (PCE) to total erythrocytes | ||||||||
| Group | Hours after dosing (hr) | Dose (mg/kg) | N | PCE/(NCE+PCE) (%) (Mean±S.D.) |
Range [PCE/(NCE+PCE)] (%) | |||
| MIN | MAX | |||||||
| Negative control | 24 | 0 | 7 | 34.2±4.37 | 30.6 |
37.8 |
||
| Positive control | 24 | 20 | 5 | 30.3±3.90 | 26.5 |
34.1 |
||
Negative control : Water for injection, Phosphrate buffered solution, 0.5% methyl cellulose 1500 centipoise solution, etc., Positive control : Cyclophosphamide (20 mg/kg, P.O., single dosing), N : The total number of micronucleus test, - : No data. The above historical control values were obtained fromn the data pooled from Feb. 26, 2016 to Apr. 24, 2020. *The range was calculated by the control limit of X derived from X-R value. a) Poisson-based 95% control limits of the historical negative control data.