Test article CMC
| Microscopic Observation |
Test | Negative Control |
Positive Control |
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| Mono layer |
Change morph. |
Mono layer |
Change morph. |
Mono layer |
Change morph. |
|
| well 1 | 1 | 0 | 1 | 0 | 3 | 4 |
| well 2 | 1 | 0 | 1 | 0 | 3 | 4 |
| well 3 | 1 | 0 | 1 | 0 | 3 | 4 |
| well 4 | 1 | 0 | 1 | 0 | 3 | 4 |
| well 5 | 1 | 0 | 1 | 0 | 3 | 4 |
| well 6 | 1 | 0 | 1 | 0 | 3 | 4 |
| average | 1.0 | 0.0 | 1.0 | 0.0 | 3.0 | 4.0 |
| correct average test |
0.0 | 0.0 | 0.0 | 0.0 | 3.0 | 4.0 |
| microscopic testaverage |
0.0 | |||||
| Test | Neg. Control | Pos. Control | Maximum | |||||||
| inhibition of cell |
OD 570 |
% inhib. |
OD 570 |
% inhib |
% inhib. Rel. to max |
OD 570 |
% inhib |
% inhib. Rel. to max |
OD 570 |
% inhib |
| well 1 | 0.799 | 20.0 | 0.962 | 3.7 | -9.1 | 0.078 | 92.2 | 91.2 | 0.857 | 2.8 |
| well 2 | 0.822 | 17.7 | 0.998 | 0.1 | -13.2 | 0.068 | 93.2 | 92.3 | 0.867 | 1.7 |
| well3 | 0.865 | 13.4 | 1.024 | -2.6 | -16.1 | 0.065 | 93.5 | 92.6 | 0.900 | -2.1 |
| well 4 | 0.834 | 16.5 | 1.002 | -0.4 | -13.6 | 0.067 | 93.3 | 92.4 | 0.918 | -4.1 |
| well 5 | 0.836 | 16.3 | 1.017 | -1.9 | -15.4 | 0.067 | 93.3 | 92.4 | 0.886 | -0.5 |
| well 6 | 0.801 | 19.8 | 0.988 | 1.1 | -12.1 | 0.075 | 92.5 | 91.5 | 0.862 | 2.2 |
| Sample average |
0.829 | 17.3 | 0.999 | 0.0 | -13.3 | 0.070 | 93.0 | 92.1 | 0.882 | 0.0 |
| Criteria for test |
% inhibition of negative control is -13.3 % of the maximum | |||||||||
| validation | % inhibition of positive control is 92.1 % of the maximum | |||||||||
| Grade cytotoxicity |
1 0 4 |
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| Total cytotoxic |
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| Response | 1.0 |
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Comments / conclusions
- The test complies with the validation criteria set and therefore allows further processing and assessment of all other data obtained. Data obtained for the negative control will be standardised as 0% inhibition.
- Test material demonstrates no cytotoxic effects and has passed the criteria.