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22대 대한민국 국회 국회정보길라잡이 국회의원검색
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Title page 1

Contents 1

INITIAL CONSIDERATIONS AND LIMITATIONS 5

PRINCIPLE OF THE TEST 7

DEMONSTRATION OF PROFICIENCY 9

PROCEDURE 10

DATA AND REPORTING 14

TEST REPORT 15

APPENDIX I - DEFINITIONS 22

APPENDIX II - PRINCIPLE OF MEASUREMENT OF LUCIFERASE ACTIVITY AND DETERMINATION OF THE TRANSMISSION COEFFICIENTS... 25

APPENDIX III - PROFICIENCY SUBSTANCES 28

APPENDIX IV - TEST CHEMICALS DISSOLUTION IN ASSAYS 30

APPENDIX V - CALCULATION OF THE SUPPRESSION INDEXES 34

Tables 9

Table 1. Description of terms associated with the luciferase activity in the IL-2 Luc assay 9

Appendix Tables 25

APPENDIX II - PRINCIPLE OF MEASUREMENT OF LUCIFERASE ACTIVITY AND DETERMINATION OF THE TRANSMISSION COEFFICIENTS... 25

Table 1. Definition of the parameters in the luciferase assay 25

APPENDIX III - PROFICIENCY SUBSTANCES 28

Table 1. Recommended substances for demonstrating technical proficiency with the IL-2 Luc assay 28

Table 2. Recommended substances for demonstrating technical proficiency with the IL-2 Luc LTT assay 28

Appendix Figures 30

APPENDIX IV - TEST CHEMICALS DISSOLUTION IN ASSAYS 30

Figure 1. Dissolution by vehicle 30

Figure 2. The scheme of the procedure for the assays when the chemical is prepared in distilled water at 10 mg/mL 31

Figure 3. The scheme of the procedure for the assays when the chemical is prepared in DMSO at 200 mg/mL 32

Figure 4. Determination of the concentration of the test chemicals in subsequent test runs (i.e., the second, and third run) 33

APPENDIX V - CALCULATION OF THE SUPPRESSION INDEXES 35

Figure 1. Two patterns showing one positive data point (increase) with the same trend for at least 3 consecutive data points 35

Figure 2. Two patterns showing one positive data point with the same trend for at least 3 consecutive data points in the IL-2 Luc LTT assay 36

Figure 3. Criteria to determine antimitotic, non-antimitotic or indeterminate 37

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