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Comment: TOBA-57

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titleSample from Report Table

The following shows example data for study 123 in a report table.  This report includes summary statistics (e.g. Average, Standard Deviation, Coeff. Var.) for each plate and an EC50 value for the entire assay. The grey cells in plate 1 are cells that do not contain the CHO Hamster cellsNHK cells

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)




Sample ID

Smoke Regime

Replicate Number

Plate Number

Well Number


Relative Assay Plate Absorbance Readings




Cigarette Smoke Condensate (µg/mL)

SLS (µg/mL)


EC50 (µg/ml)

0

10

50

75

100

120

140

160

200

110

200

0



030001

Medium

1

1

1

0.046*

0.046*0.039*0.012*0.030*0.003*0.057*0.032*0.003*0.050*0.044*

0.040*



030001

Medium

1

1

2

0.048*

107

77.7

65.7

30.2

15.6

9.79

5.41

2.49

8.09

0.791

0.014*



030001

Medium

1

1

3

0.005*

98.6

77.4

57.7

35.8

8.09

7.36

3.22

0.791

6.38

0.061

0.050*



030001

Medium

1

1

4

0.049*

94.9

81.5

38.2

31.2

7.60

5.17

3.22

0.791

5.17

0.304

0.017*



030001

Medium

1

1

5

0.047*

111

78.1

64.5

32.9

8.82

5.90

2.74

1.28

10.3

0.547

0.011*



030001

Medium

1

1

6

0.032*

96.6

76.2

48.0

26.8

7.84

4.20

2.74

1.52

8.09

4.93

0.022*



030001

Medium

1

1

7

0.044*

105

77.9

58.2

28.3

8.09

4.68

1.76

0.547

8.57

1.76

0.056*



030001

Medium

1

1

8

0.056*

0.013*0.040*0.008*0.013*0.002*0.029*0.018*0.006*0.016*0.024*

0.046*


Average


101

78.2

54.5

29.9

9.70

6.17

3.37

1.19

8.94

1.22



Std. Dev.


6

2.9

9.4

3.6

2.95

2.19

1.12

0.72

2.72

1.58



Coeff. Var.


5.8

3.6

17.2

11.9

30.4

35.5

33.1

61.0

30.5

129.9



*media without cells















030001

Medium

1

2

1


93.4

74.0

56.0

35.1

11.8

8.70

5.10

1.98

5.34

1.02




030001

Medium

1

2

2


102

75.2

53.3

35.1

11.8

7.74

5.58

3.66

5.34

1.02




030001

Medium

1

2

3


107

79.0

55.0

26.5

10.1

6.06

3.66

1.74

7.02

0.780




030001

Medium

1

2

4


104

80.2

55.3

29.8

8.94

3.90

3.66

1.50

6.30

0.780




030001

Medium

1

2

5


101

75.7

54.1

26.7

4.86

4.38

1.26

1.02

6.30

1.02




030001

Medium

1

2

6


110

85.7

67.7

26.0

5.34

4.62

3.42

1.50

6.30

0.540




030001

Medium

1

2

7


104

77.8

64.9

27.7

8.22

3.18

2.46

1.02

6.30

0.780




030001

Medium

1

2

8


103

71.6

58.9

25.5

9.42

4.14

3.90

1.26

4.38

0.780



Average


103

77.4

58.1

29.0

8.82

5.34

3.63

1.71

5.91

0.840



Std. Dev.


5

4.4

5.3

4.0

2.63

1.97

1.37

0.86

0.83

0.170



Coeff. Var.


4.6

5.6

9.2

13.6

29.8

36.9

37.6

50.0

14.1

20.2



EC50 (µg/ml). Effective concentration at 50% cytotoxicity.  (using a specific sigmoidal equation = model). 













123

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Dataset wrap

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-279

Rowcaps
Rows 1-12:Show the test conditions for the set with a short name or SETCD value of ALL.  The sponsor chose this value to represent test conditions for the entire assay. 
Rows 13-20:Show the test conditions for the set with a short name or SETCD value of CSC-50b.  The sponsor chose this value to represent plate number 1, well number 1, with a concentration of 50µg/mLof Cigarette Smoke Condensate as shown in the report table for study 123.
Row 20:Shows the value for STRAIN/SUBSTRAIN is NO STRAIN Cell Line, CELLLN, is NOT APPLICABLE because the well is a media only well, having no CHO Hamster NHK cells. 

Rows 21-28:

Show the test conditions for the set with a short name or SETCD value of CSC-50.  The sponsor chose this value to represent plate number 1, well number 2, with a concentration of 50µg/mLof Cigarette Smoke Condensate as shown in the report table for study 123.
Rows 29-36:Show the test conditions for the set with a short name or SETCD value of SLS-110.  The sponsor chose this value to represent both wells numbered 7 in plate number 1 and 2, with a concentration of 110µg/mLof Sodium Laurel Sulfate as shown in the report table for study 123.
Dataset2
NO STRAINCHOCHO
RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123NRUTXALLALL_ASSAY1TRTDMINTreatment Duration Minimum47.5
2123NRUTXALLALL_ASSAY

2

TRTDTRGTreatment Duration Target48
3123NRUTXALLALL_ASSAY3TRTDMAXTreatment Duration Maximum48.5
4123NRUTXALLALL_ASSAY4TRTDUTreatment Duration UnitHOURS
5123NRUTXALLALL_ASSAY5INCBTMPIncubation Temperature37
6123NRUTXALLALL_ASSAY6INCBTMPUIncubation Temperature UnitC
7123NRUTXALLALL_ASSAY7WAVELGTHSpectrophotometer wavelength in nanometers540
8123NRUTXALLALL_ASSAY8HUMIDAtmospheric Relative Humidity Percent90
9123NRUTXALLALL_ASSAY9ATMCO2Atmospheric CO2 Percent5
10123NRUTXALLALL_ASSAY10SPDEVIDSponsor defined device identifierPUFFMASTER3k
11123NRUTXALLALL_ASSAY11DUREFIDSmoking RegimeMedium Intensity Regimen
12123NRUTXALLALL_ASSAY12SPTOBID

Sponsor defined tobacco identifier

CIG01a
13123NRUTXCSC-50bCSC-50-blank13PSETCD

Parent Set Code

ALL
14123NRUTXCSC-50bCSC-50-blank14EXPTYP

Exposure Type

Air Liquid Interface
15123NRUTXCSC-50bCSC-50-blank15SAMTYPSample TypeWhole Smoke Conditioned Media
16123NRUTXCSC-50bCSC-50-blank16INTRVNName of the Intervention ArticleTobacco ProdA
17123NRUTXCSC-50bCSC-50-blank17ITVTYPEtype of intervention articlePRODUCT
18123NRUTXCSC-50bCSC-50-blank18ITVCONCintervention concentration50
19123NRUTXCSC-50bCSC-50-blank19ITVCONCUintervention unitug/ml
20123NRUTXCSC-50bCSC-50-blank20STRAINStrain/SubstrainCELLLNCell LineNOT APPLICABLE
21123NRUTXCSC-50CSC-5021PSETCD

Parent Set Code

ALL
22123NRUTXCSC-50CSC-5022EXPTYP

Exposure Type

Air Liquid Interface
23123NRUTXCSC-50CSC-5023SAMTYPSample TypeWhole Smoke Conditioned Media
24123NRUTXCSC-50CSC-5024INTRVNName of the Intervention ArticleTobacco ProdA
25123NRUTXCSC-50CSC-5025ITVTYPEtype of intervention articlePRODUCT
26123NRUTXCSC-50CSC-5026ITVCONCintervention concentration50
27123NRUTXCSC-50CSC-5027ITVCONCUintervention unitug/ml
28123NRUTXCSC-50CSC-5028STRAINStrain/SubstrainCELLLNCell LineNHK
29123NRUTXSLS-110SLS-11029PSETCD

Parent Set Code

ALL
30123NRUTXSLS-110SLS-11030EXPTYP

Exposure Type

Air Liquid Interface
31123NRUTXSLS-110SLS-11031SAMTYPSample TypeLiquid
32123NRUTXSLS-110SLS-11032INTRVNName of the Intervention ArticleSodium Laurel Sulfate
33123NRUTXSLS-110SLS-11033ITVTYPEtype of intervention articlePOSITIVE CONTROL
34123NRUTXSLS-110SLS-11034ITVCONCintervention concentration200
35123NRUTXSLS-110SLS-11035ITVCONCUintervention unitug/ml
36123NRUTXSLS-110SLS-11036STRAINStrain/SubstrainCELLLNCell LineNHK
Dataset wrap
Namerelref

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-280

Rowcaps
Row 1:Shows the REFID of 123NRU that indicates the entire assay.
Rows 2, 5, 8, 9:Show the REFIDs at the second level, all within the parent assay of 123NRU (REFID values of 1-3b, 1-3, 1-10, 2-10).
Rows 3-4, 6-7, 10-11: Show REFID values that the sponsor chose, in this case, to represent the plate number (1 or 2), column (1 - 10), and row (A-G) of the 96-well plate.
Rows 3-4:Show the REFIDs 1-3-A and 1-3-H that indicate two experimental units within the parent Trial Set of 1-3b.
Rows 6-7:Show the REFIDs 1-3-B and 1-3-C that indicate two experimental units within the parent Trial Set of 1-3.
Row 10:Shows the REFID of 1-10-G that indicates the experimental unit within the parent Trial Set of 1-10.
Row 11: Shows the REFID of 2-10-G that indicates the experimental unit within the parent Trial Set of 2-10.
Dataset2
tableidrelref

Row

STUDYID

GNTXAID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1123NRUALL123NRU
1ASSAY
2123NRU

CSC-50b

1-3b123NRU2TRIAL SET
3123NRU

CSC-50b

1-3-A1-3b3EXPERIMENTAL UNIT
4123NRU

CSC-50b

1-3-H1-3b3EXPERIMENTAL UNIT
5123NRUCSC-501-3123NRU2TRIAL SET
6123NRUCSC-501-3-B1-33EXPERIMENTAL UNIT
7123NRUCSC-501-3-C1-33EXPERIMENTAL UNIT
8123NRUSLS-1101-10123NRU2TRIAL SET
9123NRUSLS-1102-10123NRU2TRIAL SET
10123NRUSLS-1101-10-G1-103EXPERIMENTAL UNIT
11123NRUSLS-1102-10-G2-103EXPERIMENTAL UNIT

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