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 Identifier
SPDEVID = SPTOBID for Sponsor Tobacco Device Identifier
DO/DU = Tobacco Design Parameters (DP)
LB = Tobacco Product Testing (TT)
Shelf life study has a protocol and provides the results of shelf life studies of Vapes 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 Vapes products for one testing condition at one timepoint and one replicate.
Tobacco Product Testing (TT) is a Findings domain similar to the Laboratory Test Results domain.
Row 1:
Shows the TTTEST of Potential Combustion Products which reflects the percentage of potential for combustion in the E-Liquid substance for the condition noted in TTTSTCND which is E-Liquid Standard (Long Term) Condition.
Rows 2, 3:
Shows the pH and Water Activity with the E-Liquid substance for the condition noted in TTTSTCND which is E-Liquid Standard (Long Term) Condition.
Rows 4, 5, 6:
Shows the NNK, NNN, and TSN tests in the E-Liquid substance for the condition noted in TTTSTCND which is E-Liquid Standard (Long Term) Condition.
Rows 7 - 9:
Show the other analytes used in testing (aerobic plate count, mold, and yeast) using the TTTEST and TTTESTCD variables.
Row Captions Debug Messages
Remember to keep number agreement between labels and captions.
Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.
*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 portions of the content using the TEST of Potential Combustion Products and Microbial 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 TTTPTNUM of 2,3, etc. are not shown for visual viewing purposes.
Rows 1-9:
Show the TTTEST of Potential Combusion Products for E-Liquid Standard (Long Term) Condition which is shown in TTTSTCND. The sample of various timepoints that may be used in the testing for Potential Combusion Products is reflected in TTTPT. The TTTPTNUM 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 TTTEST of Potential Combusion Products for E-Liquid Accelerated Aging Condition across the same timepoints. The TTGRPID is used to tie together a block of related records in a single domain.
Rows 19-28:
Show the TTTEST of MIcrobiological for E-Vapor Standard Aerosol Condition across the same timepoints. The TTGRPID is used to tie together a block of related records in a single domain.
Rows 29-36:
Show the TTTEST of MIcrobiological for E-Vapor Intense Aerosol Condition across the same timepoints. The TTGRPID is used to tie together a block of related records in a single domain.