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Comment: Flattened TX domain per CTP CDER CBER meetings

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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 NRU. 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 column 3, with a concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123.  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, 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 plate number 1, well rows B-G, well column 10, and plate number 2, 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.



FLATTENED

Dataset2

ORIGINAL

RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123TXNRUNRU_ASSAY1IVTDMINIn vitro Treatment Duration Minimum47.5
2123TXNRUNRU_ASSAY

2

IVTDTRGIn vitro Treatment Duration Target48
3123TXNRUNRU_ASSAY3IVTDMAXIn vitro Treatment Duration Maximum48.5
4123TXNRUNRU_ASSAY4IVTDUIn vitro Treatment Duration UnitHOURS
5123TXNRUNRU_ASSAY5INCBTMPIncubation Temperature37
6123TXNRUNRU_ASSAY6INCBTMPUIncubation Temperature UnitC
7123TXNRUNRU_ASSAY7SWAVENMSpectrophotometer Wavelength540
8123TXNRUNRU_ASSAY8ATMRHPAtmospheric Relative Humidity Percent90
9123TXNRUNRU_ASSAY9ATMCO2PAtmospheric CO2 Percent5
10123TXNRUNRU_ASSAY10SPDEVIDapplicant defined device identifierPUFFMASTER3k
11123TXNRUNRU_ASSAY11SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
12123TXNRUNRU_ASSAY12SPTOBID

Applicant-defined tobacco identifier

CIG01a
13123TXCSC-50bCSC-50-blank13PSETCD

Parent Set Code

NRU
14123TXCSC-50bCSC-50-blank14EXPTYP

Exposure Type

Air Liquid Interface
15123TXCSC-50bCSC-50-blank15SAMTYPSample TypeWhole Smoke Conditioned Media
16123TXCSC-50bCSC-50-blank16ITVNAMName of the Intervention ArticleTobacco ProdA
17123TXCSC-50bCSC-50-blank17ITVTYPEIntervention Article TypePRODUCT
18123TXCSC-50bCSC-50-blank18ITVCONC

Intervention Article Concentration

50
19123TXCSC-50bCSC-50-blank19ITVCONCUIntervention Article Concentration Unitug/ml
20123TXCSC-50bCSC-50-blank20CELLLNCell LineNOT APPLICABLE
21123TXCSC-50CSC-5021PSETCD

Parent Set Code

NRU
22123TXCSC-50CSC-5022EXPTYP

Exposure Type

Air Liquid Interface
23123TXCSC-50CSC-5023SAMTYPSample TypeWhole Smoke Conditioned Media
24123TXCSC-50CSC-5024ITVNAMIntervention Article NameTobacco ProdA
25123TXCSC-50CSC-5025ITVTYPEIntervention Article TypePRODUCT
26123TXCSC-50CSC-5026ITVCONC

Intervention Article Concentration

50
27123TXCSC-50CSC-5027ITVCONCUIntervention Article Concentration Unitug/ml
28123TXCSC-50CSC-5028CELLLNCell LineNHK
29123TXSLS-110

SLS-110

Jira
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serverIssue Tracker (JIRA)
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29PSETCD

Parent Set Code

NRU
30123TXSLS-110SLS-11030EXPTYP

Exposure Type

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

Intervention Article Concentration

110

Jira
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serverIssue Tracker (JIRA)
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35123TXSLS-110SLS-11035ITVCONCUIntervention Article Concentration Unitug/ml
36123TXSLS-110SLS-11036CELLLNCell LineNHK
ROWSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123TXNRUNRU_ASSAY1IVTDMINIn vitro Treatment Duration Minimum47.5
2123TXNRUNRU_ASSAY2IVTDTRGIn vitro Treatment Duration Target48
3123TXNRUNRU_ASSAY3IVTDMAXIn vitro Treatment Duration Maximum48.5
4123TXNRUNRU_ASSAY4IVTDUIn vitro Treatment Duration UnitHOURS
5123TXNRUNRU_ASSAY5INCBTMPIncubation Temperature37
6123TXNRUNRU_ASSAY6INCBTMPUIncubation Temperature UnitC
7123TXNRUNRU_ASSAY7SWAVENMSpectrophotometer Wavelength540
8123TXNRUNRU_ASSAY8ATMRHPAtmospheric Relative Humidity Percent90
9123TXNRUNRU_ASSAY9ATMCO2PAtmospheric CO2 Percent5
10123TXNRUNRU_ASSAY10SPDEVIDapplicant defined device identifierPUFFMASTER3k
11123TXNRUNRU_ASSAY11SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
12123TXNRUNRU_ASSAY12SPTOBID

Applicant-defined tobacco identifier

CIG01a
13123TXCSC-50bCSC-50-blank13IVTDMINIn vitro Treatment Duration Minimum47.5
14123TXCSC-50bCSC-50-blank14IVTDTRGIn vitro Treatment Duration Target48
15123TXCSC-50bCSC-50-blank15IVTDMAXIn vitro Treatment Duration Maximum48.5
16123TXCSC-50bCSC-50-blank16IVTDUIn vitro Treatment Duration UnitHOURS
17123TXCSC-50bCSC-50-blank17INCBTMPIncubation Temperature37
18123TXCSC-50bCSC-50-blank18INCBTMPUIncubation Temperature UnitC
19123TXCSC-50bCSC-50-blank19SWAVENMSpectrophotometer Wavelength540
20123TXCSC-50bCSC-50-blank20ATMRHPAtmospheric Relative Humidity Percent90
21123TXCSC-50bCSC-50-blank21ATMCO2PAtmospheric CO2 Percent5
22123TXCSC-50bCSC-50-blank22SPDEVIDapplicant defined device identifierPUFFMASTER3k
23123TXCSC-50bCSC-50-blank23SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
24123TXCSC-50bCSC-50-blank24SPTOBID

Applicant-defined tobacco identifier

CIG01a
25123TXCSC-50bCSC-50-blank25EXPTYP

Exposure Type

Air Liquid Interface
26123TXCSC-50bCSC-50-blank26SAMTYPSample TypeWhole Smoke Conditioned Media
27123TXCSC-50bCSC-50-blank27ITVNAMName of the Intervention ArticleTobacco ProdA
28123TXCSC-50bCSC-50-blank28ITVTYPEIntervention Article TypePRODUCT
29123TXCSC-50bCSC-50-blank29ITVCONC

Intervention Article Concentration

50
30123TXCSC-50bCSC-50-blank30ITVCONCUIntervention Article Concentration Unitug/ml
31123TXCSC-50bCSC-50-blank31CELLLNCell LineNOT APPLICABLE
32123TXCSC-50CSC-5032IVTDMINIn vitro Treatment Duration Minimum47.5
33123TXCSC-50CSC-5033IVTDTRGIn vitro Treatment Duration Target48
34123TXCSC-50CSC-5034IVTDMAXIn vitro Treatment Duration Maximum48.5
35123TXCSC-50CSC-5035IVTDUIn vitro Treatment Duration UnitHOURS
36123TXCSC-50CSC-5036INCBTMPIncubation Temperature37
37123TXCSC-50CSC-5037INCBTMPUIncubation Temperature UnitC
38123TXCSC-50CSC-5038SWAVENMSpectrophotometer Wavelength540
39123TXCSC-50CSC-5039ATMRHPAtmospheric Relative Humidity Percent90
40123TXCSC-50CSC-5040ATMCO2PAtmospheric CO2 Percent5
41123TXCSC-50CSC-5041SPDEVIDapplicant defined device identifierPUFFMASTER3k
42123TXCSC-50CSC-5042SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
43123TXCSC-50CSC-5043SPTOBID

Applicant-defined tobacco identifier

CIG01a
44123TXCSC-50CSC-5044EXPTYP

Exposure Type

Air Liquid Interface
4445123TXCSC-50CSC-504445SAMTYPSample TypeWhole Smoke Conditioned Media
4546123TXCSC-50CSC-504546ITVNAMIntervention Article NameTobacco ProdA
4647123TXCSC-50CSC-504647ITVTYPEIntervention Article TypePRODUCT
4748123TXCSC-50CSC-504748ITVCONC

Intervention Article Concentration

50
4849123TXCSC-50CSC-504849ITVCONCUIntervention Article Concentration Unitug/ml
4950123TXCSC-50CSC-504950CELLLNCell LineNHK
5051123TXSLS-110SLS-1105051IVTDMINIn vitro Treatment Duration Minimum47.5
5152123TXSLS-110SLS-1105152IVTDTRGIn vitro Treatment Duration Target48
5253123TXSLS-110SLS-1105253IVTDMAXIn vitro Treatment Duration Maximum48.5
5354123TXSLS-110SLS-1105354IVTDUIn vitro Treatment Duration UnitHOURS
5455123TXSLS-110SLS-1105455INCBTMPIncubation Temperature37
5556123TXSLS-110SLS-1105556INCBTMPUIncubation Temperature UnitC
5657123TXSLS-110SLS-1105657SWAVENMSpectrophotometer Wavelength540
5758123TXSLS-110SLS-1105758ATMRHPAtmospheric Relative Humidity Percent90
5859123TXSLS-110SLS-1105859ATMCO2PAtmospheric CO2 Percent5
5960123TXSLS-110SLS-1105960SPDEVIDapplicant defined device identifierPUFFMASTER3k
6061123TXSLS-110SLS-1106061SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
6162123TXSLS-110SLS-1106162SPTOBID

Applicant-defined tobacco identifier

CIG01a
6263123TXSLS-110SLS-1106263EXPTYP

Exposure Type

Air Liquid Interface
6364123TXSLS-110SLS-1106364SAMTYPSample TypeLiquid
6465123TXSLS-110SLS-1106465ITVNAMIntervention Article NameSodium Laurel Sulfate
6566123TXSLS-110SLS-1106566ITVTYPEIntervention Article TypePOSITIVE CONTROL
6667123TXSLS-110SLS-1106667ITVCONC

Intervention Article Concentration

110

Jira
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serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-600


6768123TXSLS-110SLS-1106768ITVCONCUIntervention Article Concentration Unitug/ml
6869123TXSLS-110SLS-1106869CELLLNCell LineNHK

Jira
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serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-461

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