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Comment: TOBA-748 CT Revisions

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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 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 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 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 applicant 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
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 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-blank16INTRVNITVNAMName of the Intervention ArticleTobacco ProdA
17123NRUTXCSC-50bCSC-50-blank17ITVTYPEIntervention Article Type of intervention articlePRODUCT
18123NRUTXCSC-50bCSC-50-blank18ITVCONC

Intervention Article Concentration of intervention article

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-5024INTRVNITVNAMName of the Intervention Article NameTobacco ProdA
25123NRUTXCSC-50CSC-5025ITVTYPEIntervention Article Type of intervention articlePRODUCT
26123NRUTXCSC-50CSC-5026ITVCONC

Intervention Article Concentration of intervention article

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-11032INTRVNITVNAMName of the Intervention Article NameSodium Laurel Sulfate
33123NRUTXSLS-110SLS-11033ITVTYPEIntervention Article Type of intervention articlePOSITIVE CONTROL
34123NRUTXSLS-110SLS-11034ITVCONC

Intervention Article Concentration of intervention article

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

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