You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 50 Next »

This example will need to be updated following the ENDS stability study approach, which was created to reflect recent developments and consultation with CDISC ISMT

NOTE TO TEAM REVIEWERS:

The example below demonstrates the required data structure of one record per analyte per replicate per test condition per timepoint to accurately represent data from a stability study.
The resulting structure would require 648 rows to illustrate the 12 analytes shown in the example study we received, done in triplicate under two test conditions at the number of timepoints in the example study.

For conciseness, we have abbreviated the examples below to demonstrate the concepts as follows:

First- we show all 12 analytes as a single replicate, at one time point and one test condition in order to illustrate the variables and terminology required to put together a stability study with assays  done in replicate at different time points and varying test conditions, even though only one record per analyte is illustrated.

Second- We show ONE analyte (moisture) in triplicate, over a series of time points and two test conditions to give a sense of what the complete data would look like.

Hopefully users could combine the information shown in both examples to construct a complete dataset containing all the records for each analyte-replicate-test condition-time point group.

Tobacco domains

DI = TO for Tobacco Product Identifiers and Descriptors

SPDEVID = SPTOBID for Sponsor Tobacco Product Identifier

DO/DU = Tobacco Product Design Parameters (PD)

LB = Tobacco Product Testing (PT) - [Would Findings be better?]


Shelf life study has a protocol and provides the results of shelf life studies of tobacco products over time with different conditions and analytes.  Generally there are many conditions with at least two with varying temperature, humidity, etc.

The initial table shows the a number of the analytes and test conditions used in Shelf Life studies for tobacco products for one testing condition at one timepoint and one replicate.


Tobacco Product Testing (PT) is a Findings domain similar to the Laboratory Test Results domain.


Row 1:Shows the PTTEST of Product Moisture which reflects the percentage of moisture in the substance for the condition noted in PTTSTCND which is Condition 1 (X°C/ Z% RH). Product Moisture is sometimes referred to as "Oven Volatiles".
Rows 4, 6, 8:Show the NNK, NNN, and TSN tests with the tobacco product "as-is" using the PTSPCCND to show that the tobacco is "FRESH".
Rows 5, 7, 9:Show the NNK, NNN, and TSN tests with the tobacco product as "Dry weight basis (DWB)" using the TTSPCCND to show that the tobacco is "DRIED".
Rows 2-12:Show the other analytes used in testing (pH, water activity, NNK, NNN, TSNA, etc.) using the PTTEST and PTTESTCD variables.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTREFIDPTTESTCDPTTESTPTCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)1TOB77777.1PRODMSTProduct MoistureSTABILITY STUDY52.0%52.052.0%TOBACCO


1Week 01
2TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)2TOB77777.1PHpHSTABILITY STUDY8.06
8.068.06
TOBACCO


1Week 01
3TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)3TOB77777.1H2OACTWater ActivitySTABILITY STUDY0.86
0.860.86
TOBACCO


1Week 01
4TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)4TOB77777.1NNK4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)STABILITY STUDY1.0225ug/g1.02251.0225ug/gTOBACCO, FRESHas-is

1Week 01
5TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)5TOB77777.1NNK4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)STABILITY STUDY0.4908ug/g0.49080.4908ug/gTOBACCO, DRIEDdry weight

1Week 01
6TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)6TOB77777.1NNNN-nitrosonornicotineSTABILITY STUDY4.4633ug/g4.46334.4633ug/gTOBACCO, FRESHas-is

1Week 01
7TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)7TOB77777.1NNNN-nitrosonornicotineSTABILITY STUDY2.1424ug/g2.14242.1424ug/gTOBACCO, DRIEDdry weight

1Week 01
8TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)8TOB77777.1TSNATobacco-specific nitrosaminesSTABILITY STUDY7.598ug/g7.5987.598ug/gTOBACCO, FRESHas-is

1Week 01
9TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)9TOB77777.1TSNATobacco-specific nitrosaminesSTABILITY STUDY3.7453ug/g3.74533.7453ug/gTOBACCO, DRIEDdry weight

1Week 01
10TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)10TOB77777.1AEBPLCTAerobic Plate CountSTABILITY STUDY154000CFU/g154000154000CFU/gTOBACCO


1Week 01
11TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)11TOB77777.1MOLDMoldSTABILITY STUDY<10CFU/g<10<10CFU/gTOBACCO


1Week 01
12TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)12TOB77777.1YEASTYeastSTABILITY STUDY<10CFU/g<10<10CFU/gTOBACCO


1Week 01

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

*DWB=Dry weight basis. The DWB normalizes the results since starting moisture may vary.


A Shelf Life study dataset would shows analytes done in different test conditions with replicates over time points.  In the interest of brevity for this example, only moisture content using the TEST of Product Moisture (also known as Oven Volatile) percentage is shown in a sample of timepoints in two conditions with replicates. The weeks reflective of Week 1,  Week 2, Week 3, etc. which would align with the PTTPTNUM of 2,3, etc. are not shown for visual viewing purposes.


Rows 1-9:Show the PTTEST of Product Moisture for Condition 1 (X°C/ Z% RH) which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for product moisture is reflected in PTTPT. The PTTPTNUM shows the numerical version of the planned timepoint. The REPNUM shows the incidence number of a test that is repeated within a given timeframe for the same test.
Rows 10-18:Show the PTTEST of Product Moisture for Condition 2 Condition 2 (A °C/ B %RH) across the same timepoints shown for Condition 1. The PTGRPID is used to tie together a block of related records in a single domain.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTREFIDPTTESTCDPTTESTPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTREPNUMPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)111TOB77777.1PRODMSTProduct Moisture51.93%51.9351.93%TOBACCOADD these
1Week 01
2TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)112TOB77777.1PRODMSTProduct Moisture51.96%51.9651.96%TOBACCO

2Week 01
3TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)113TOB77777.1PRODMSTProduct Moisture51.98%51.9851.98%TOBACCO

3Week 01
4TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)114TOB77777.1PRODMSTProduct Moisture51.75%51.7551.75%TOBACCO

1Week 84
5TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)115TOB77777.1PRODMSTProduct Moisture51.75%51.7551.75%TOBACCO

2Week 84
6TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)116TOB77777.1PRODMSTProduct Moisture51.67%51.6751.67%TOBACCO

3Week 84
7TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)117TOB77777.1PRODMSTProduct Moisture52.05%52.0552.05%TOBACCO

1Week 489
8TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)118TOB77777.1PRODMSTProduct Moisture52.68%52.6852.68%TOBACCO

2Week 489
9TOB07PTSmokeless01Condition 1 (X°C/ Z% RH)119TOB77777.1PRODMSTProduct Moisture52.21%52.2152.21%TOBACCO

3Week 489
10TOB07PTSmokeless01Condition 2 (A °C/ B %RH)120TOB77777.1PRODMSTProduct Moisture51.93%51.9351.93%TOBACCO

1Week 01
11TOB07PTSmokeless01Condition 2 (A °C/ B %RH)121TOB77777.1PRODMSTProduct Moisture51.96%51.9651.96%TOBACCO

2Week 01
12TOB07PTSmokeless01Condition 2 (A °C/ B %RH)122TOB77777.1PRODMSTProduct Moisture51.98%51.9851.98%TOBACCO

3Week 01
13TOB07PTSmokeless01Condition 2 (A °C/ B %RH)123TOB77777.1PRODMSTProduct Moisture51.80%51.8051.80%TOBACCO

1Week 84
14TOB07PTSmokeless01Condition 2 (A °C/ B %RH)124TOB77777.1PRODMSTProduct Moisture51.77%51.7751.77%TOBACCO

2Week 84
15TOB07PTSmokeless01Condition 2 (A °C/ B %RH)125TOB77777.1PRODMSTProduct Moisture51.84%51.8451.84%TOBACCO

3Week 84
16TOB07PTSmokeless01Condition 2 (A °C/ B %RH)126TOB77777.1PRODMSTProduct Moisture52.18%52.1852.18%TOBACCO

1Week 489
17TOB07PTSmokeless01Condition 2 (A °C/ B %RH)127TOB77777.1PRODMSTProduct Moisture52.21%52.2152.21%TOBACCO

2Week 489
18TOB07PTSmokeless01Condition 2 (A °C/ B %RH)128TOB77777.1PRODMSTProduct Moisture51.87%51.8751.87%TOBACCO

3Week 489

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

From previous page: - update for this example.... values are likely different - ??? - Condition 1 and Condition 2

The Test Conditions (TC) dataset allows for listing the attributes of the testing regimens used in tobacco product testing when the details are too long and variable for representing as a single value in the PTTSTCND variable in a PT dataset. 

The example below shows the attributes of the testing regimen identified as PTTSTCND="E-Liquid Standard Aerosol Condition" (see e-liquid stability study pt.xpt example). Note that the combination of TCVAR1="PTTSTCND" and TCVRVAL1="E-Liquid Standard (Long Term) Condition" identifies the specific testing regimen shown in PTTSTCND as the focus of the testing regimen parameters listed in TCPARMCD/TCPARM. TCVAL and TCVALU show the specific values and units (respectively, where applicable) for the given parameter.one testing regimen shown in the PT stability study above. 
(We've added TCVALU which was not originally part of the TC draft domain. May propose elevating this structure to a "Trial Lookup" observational class, within which some domains would allow for TCVALU) 

tc.xpt

tc.xpt

RowSTUDYIDDOMAINRDOMAINTCVAR1TCVRVAL1TCSEQTCGRPIDTCPARMCDTCPARMTCVALTCVALU
1

TOB07

TCPTPTTSTCNDSmokeless Standard (Long Term) Condition1
PUFFPROFPuff ProfileSQUARE
2

TOB07

TCPTPTTSTCNDSmokeless Standard (Long Term) Condition2


PUFFDUR

Puff Duration

1.25

sec

3

TOB07

TCPTPTTSTCNDSmokeless Standard (Long Term) Condition3


PUFFINT

Puff Interval

3

PUFF/min

4

TOB07

TCPTPTTSTCNDSmokeless Standard (Long Term) Condition4


PUFFBLCK

Puff Block

25

%

5

TOB07

TCPTPTTSTCNDSmokeless Standard (Long Term) Condition5
NUMPUFFTotal Number of Puffs

200

PUFF

6

TOB07

TCPTPTTSTCNDSmokeless Standard (Long Term) Condition6
PUFFVOLPuff Volume

10

mL

7

TOB07

TCPTPTTSTCNDSmokeless Standard (Long Term) Condition7
PUFFRNGPuff Range

100-200


8

TOB07

TCPTPTTSTCNDSmokeless Standard (Long Term) Condition81PUFFPAUSPuff Pause

60

s

9TOB07TCPTPTTSTCNDSmokeless Standard (Long Term) Condition91PUFFPINTPuff Pause Interval

10

PUFF

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

  • No labels