Page History

This example shows a report table, trial design,

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-78

and results data for the in vitro neutral red uptake (NRU) cytotoxicity assay

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-333

in example study 123.

Expand

title	Sample 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

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-593

value for the entire assay. The grey cells in plate 1 are cells value for the entire assay. In the table below, the light grey shading for plate 1 are 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.

For brevity, the datasets in this example are not comprehensive but are intended to demonstrate a range of proper use.

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data

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

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

1

A

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

2

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

3

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

4

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

5

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

6

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

7

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

8

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

1

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

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

3

C		107	79.0	55.0	26.5	10.1	6.06	3.66	1.74	7.02	0.780
	030001	Medium	1	2

4

D		104	80.2	55.3	29.8	8.94	3.90	3.66	1.50	6.30	0.780
	030001	Medium	1	2

5

E		101	75.7	54.1	26.7	4.86	4.38	1.26	1.02	6.30	1.02
	030001	Medium	1	2

6

F		110	85.7	67.7	26.0	5.34	4.62	3.42	1.50	6.30	0.540
	030001	Medium	1	2

7

G		104	77.8	64.9	27.7	8.22	3.18	2.46	1.02	6.30	0.780
	030001	Medium	1	2

8

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

TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	123

	TS	1		GLPFL	GLP Flag	Y
4	123

TS	1	4	TSTGDNAM	Testing Guideline Name	Publication No. 07-4519
15	123

	TS	1	4	TSTGDORG	Testing Guideline Organization	NIH
16	123

	TS	1	4	TSTGDVER	Testing Guideline Version	2006-11
17	123

Page tree

Versions Compared

Old Version 105

New Version Current

Key

NRU_ASSAY	10	SPDEVID	applicant defined device identifier	PUFFMASTER3k
11	123	TX	NRU

NRU_ASSAY	12	SPTOBID	Applicant-defined tobacco identifier	CIG01a
13	123

	INCBTMP	Incubation Temperature	37
37	123	TX	CSC-50	CSC-50	37	INCBTMPU	Incubation Temperature Unit	C
38	123	TX	CSC-50	CSC-50	38	SWAVENM	Spectrophotometer Wavelength	540
39	123	TX	CSC-50	CSC-50	39	ATMRHP	Atmospheric Relative Humidity Percent	90
40	123	TX	CSC-50	CSC-50	40	ATMCO2P	Atmospheric CO2 Percent	5
41	123	TX	CSC-50	CSC-50	41	SPDEVID	applicant defined device identifier	PUFFMASTER3k
42	123	TX	CSC-50	CSC-50	42	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
43	123	TX	CSC-50	CSC-50	43	SPTOBID	Applicant-defined tobacco identifier	CIG01a
44	123	TX	CSC-50	CSC-50	44	EXPTYP	Exposure Type	Air Liquid Interface
45	123	TX	CSC-50	CSC-50	45	SAMTYP	Sample Type	Whole Smoke Conditioned Media
46	123	TX	CSC-50	CSC-50	46	ITVNAM	Intervention Article Name	Tobacco ProdA
47	123	TX	CSC-50	CSC-50	47	ITVTYPE	Intervention Article Type	PRODUCT
48	123	TX	CSC-50	CSC-50	48	ITVCONC	Intervention Article Concentration	50
49	123	TX	CSC-50	CSC-50	49	ITVCONCU	Intervention Article Concentration Unit	ug/ml
50	123	TX	CSC-50	CSC-50	50	CELLLN	Cell Line	NHK
51	123	TX	SLS-110	SLS-110	51	IVTDMIN	In vitro Treatment Duration Minimum	47.5
52	123	TX	SLS-110	SLS-110	52	IVTDTRG	In vitro Treatment Duration Target	48
53	123	TX	SLS-110	SLS-110	53	IVTDMAX	In vitro Treatment Duration Maximum	48.5
54	123	TX	SLS-110	SLS-110	54	IVTDU	In vitro Treatment Duration Unit	HOURS
55	123	TX	SLS-110	SLS-110	55	INCBTMP	Incubation Temperature	37
56	123	TX	SLS-110	SLS-110	56	INCBTMPU	Incubation Temperature Unit	C
57	123	TX	SLS-110	SLS-110	57	SWAVENM	Spectrophotometer Wavelength	540
58	123	TX	SLS-110	SLS-110	58	ATMRHP	Atmospheric Relative Humidity Percent	90
59	123	TX	SLS-110	SLS-110	59	ATMCO2P	Atmospheric CO2 Percent	5
60	123	TX	SLS-110	SLS-110	60	SPDEVID	applicant defined device identifier	PUFFMASTER3k
61	123	TX	SLS-110	SLS-110	61	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
62	123	TX	SLS-110	SLS-110	62	SPTOBID	Applicant-defined tobacco identifier	CIG01a
63	123	TX	SLS-110	SLS-110	63	EXPTYP	Exposure Type	Air Liquid Interface
64	123	TX	SLS-110	SLS-110	64	SAMTYP	Sample Type	Liquid
65	123	TX	SLS-110	SLS-110	65	ITVNAM	Intervention Article Name	Sodium Laurel Sulfate
66	123	TX	SLS-110	SLS-110	66	ITVTYPE	Intervention Article Type	POSITIVE CONTROL
67	123	TX	SLS-110	SLS-110	67	ITVCONC	Intervention Article Concentration	110
68	123	TX	SLS-110	SLS-110	68	ITVCONCU	Intervention Article Concentration Unit	ug/ml
69	123	TX	SLS-110	SLS-110	69	CELLLN	Cell Line	NHK

GT	2	1-3-B	BKCABS	Background Corrected Absorbance Reading	1.6			1.6	1.6
3	123

	GT	5	1-3-C	BKCABS	Background Corrected Absorbance Reading	1.7			1.7	1.7
6	123

GT	7	1-3	RELABS	Relative Absorbance Reading	78.2	%	MEAN	78.2	78.2	%
8	123

GT	8	1-3	RELABS	Relative Absorbance Reading	2.9	%	STANDARD DEVIATION	2.9	2.9	%
9	123

GT	9	1-3	RELABS	Relative Absorbance Reading	3.6		COEFFICIENT OF VARIANCE	3.6	3.6
10	123

	GT	11	1-10-G	BKCABS	Background Corrected Absorbance Reading	0.6			0.6	0.6
12	123

GT	13	1-10	RELABS	Relative Absorbance Reading	8.94	%	MEAN	8.94	8.94
14	123

GT	17	2-10-G	BKCABS	Background Corrected Absorbance Reading	0.8
18	123

GT	19	2-10	RELABS	Relative Absorbance Reading	5.91	%	MEAN	5.91	5.91
20	123