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Comment: TOBA-601

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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 (i.e., average, standard deviation, coefficient variation) for each plate and an EC50

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-593
value for the entire assay. The grey cells in In the table below, the light grey shading for plate 1 are cells values from wells that do not contain the NHK cells.  The dark grey shading represents the column and row location within the 96-well plate, and in this example the applicant chose to use these column and row locations to assign their REFID values in the RELREF dataset and GT dataset.

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)




Sample ID

Smoke Regime

Replicate Number

Plate Number



Relative Assay Plate Absorbance Readings





Cigarette Smoke Condensate (µg/mL) 

SLS (µg/mL)


EC50 (µg/ml)

Well Column:

1

2

3

4

5

6

7

8

9

10

11

12


Well 
Row:

0

10

50

75

100

120

140

160

200

110

200

0



030001

Medium

1

1

A

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

B

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

C

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

D

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

E

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

F

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

G

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

H

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

A


93.4

74.0

56.0

35.1

11.8

8.70

5.10

1.98

5.34

1.02




030001

Medium

1

2

B


102

75.2

53.3

35.1

11.8

7.74

5.58

3.66

5.34

1.02




030001

Medium

1

2

C


107

79.0

55.0

26.5

10.1

6.06

3.66

1.74

7.02

0.780




030001

Medium

1

2

D


104

80.2

55.3

29.8

8.94

3.90

3.66

1.50

6.30

0.780




030001

Medium

1

2

E


101

75.7

54.1

26.7

4.86

4.38

1.26

1.02

6.30

1.02




030001

Medium

1

2

F


110

85.7

67.7

26.0

5.34

4.62

3.42

1.50

6.30

0.540




030001

Medium

1

2

G


104

77.8

64.9

27.7

8.22

3.18

2.46

1.02

6.30

0.780




030001

Medium

1

2

H


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 applicant 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 applicant chose this value to represent plate number 1, well row A, well number 1column 3, with a concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123.
Row 20:Shows the value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no NHK cells. 

Rows 21-28:

Show the test conditions for the set with a short name or SETCD value of CSC-50. The applicant chose this value to represent plate number 1, well rows B-G, well column 3 and plate number 2, with a , well rows A-H, well column 3. These all have the 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 applicant chose this value to represent both wells numbered 7 in plate number 1, well rows B-G, well column 10, and plate number 2, with a , well rows A-H, well column 10. These all have the concentration of 110µg/mLof sodium laurel sulfate as shown in the report table for study 123.
Dataset2
RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123NRUTXALLALL_ASSAY1IVTDMINIn vitro Treatment Duration Minimum47.5
2123NRUTXALLALL_ASSAY

2

IVTDTRGIn vitro Treatment Duration Target48
3123NRUTXALLALL_ASSAY3IVTDMAXIn vitro Treatment Duration Maximum48.5
4123NRUTXALLALL_ASSAY4IVTDUIn vitro Treatment Duration UnitHOURS
5123NRUTXALLALL_ASSAY5INCBTMPIncubation Temperature37
6123NRUTXALLALL_ASSAY6INCBTMPUIncubation Temperature UnitC
7123NRUTXALLALL_ASSAY7SWAVENMSpectrophotometer Wavelength540
8123NRUTXALLALL_ASSAY8ATMRHPAtmospheric Relative Humidity Percent90
9123NRUTXALLALL_ASSAY9ATMCO2PAtmospheric CO2 Percent5
10123NRUTXALLALL_ASSAY10SPDEVIDapplicant defined device identifierPUFFMASTER3k
11123NRUTXALLALL_ASSAY11SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
12123NRUTXALLALL_ASSAY12SPTOBID

Applicant-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-blank16ITVNAMName of the Intervention ArticleTobacco ProdA
17123NRUTXCSC-50bCSC-50-blank17ITVTYPEIntervention Article TypePRODUCT
18123NRUTXCSC-50bCSC-50-blank18ITVCONC

Intervention Article Concentration

50
19123NRUTXCSC-50bCSC-50-blank19ITVCONCUIntervention Article Concentration Unitug/ml
20123NRUTXCSC-50bCSC-50-blank20CELLLNCell 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-5024ITVNAMIntervention Article NameTobacco ProdA
25123NRUTXCSC-50CSC-5025ITVTYPEIntervention Article TypePRODUCT
26123NRUTXCSC-50CSC-5026ITVCONC

Intervention Article Concentration

50
27123NRUTXCSC-50CSC-5027ITVCONCUIntervention Article Concentration Unitug/ml
28123NRUTXCSC-50CSC-5028CELLLNCell LineNHK
29123NRUTXSLS-110SLS-11029PSETCD

Parent Set Code

ALL
30123NRUTXSLS-110SLS-11030EXPTYP

Exposure Type

Air Liquid Interface
31123NRUTXSLS-110SLS-11031SAMTYPSample TypeLiquid
32123NRUTXSLS-110SLS-11032ITVNAMIntervention Article NameSodium Laurel Sulfate
33123NRUTXSLS-110SLS-11033ITVTYPEIntervention Article TypePOSITIVE CONTROL
34123NRUTXSLS-110SLS-11034ITVCONC

Intervention Article Concentration

110
35123NRUTXSLS-110SLS-11035ITVCONCUIntervention Article Concentration Unitug/ml
36123NRUTXSLS-110SLS-11036CELLLNCell LineNHK

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